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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
(Mark One)
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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OR | |
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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OR | |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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OR | |
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Date of event requiring this shell company report…………………………………..
For the transition period from to
Commission file number: 001-11960
ASTRAZENECA PLC |
(Exact name of Registrant as specified in its charter) |
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England and Wales |
(Jurisdiction of incorporation or organization) |
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1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA England |
(Address of principal executive offices) |
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Adrian Kemp AstraZeneca PLC 1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA England Telephone: +44 20 3749 5000 Facsimile number: +44 1223 352 858 |
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) |
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading symbol(s) |
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Name of each exchange on which registered |
American Depositary Shares, each representing one half of an Ordinary Share of 25¢ each |
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AZN |
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The Nasdaq Stock Market LLC |
Ordinary Shares of 25¢ each |
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The Nasdaq Stock Market LLC * |
0.700% Notes due 2024 |
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AZN 24 |
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The Nasdaq Stock Market LLC |
3.375% Notes due 2025 |
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AZN 25 |
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The Nasdaq Stock Market LLC |
0.700% Notes due 2026 |
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AZN 26 |
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The Nasdaq Stock Market LLC |
1.200% Notes due 2026 |
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AZN 26A |
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The Nasdaq Stock Market LLC |
3.125% Notes due 2027 |
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AZN 27A |
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The Nasdaq Stock Market LLC |
1.750% Notes due 2028 |
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AZN 28 |
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The Nasdaq Stock Market LLC |
4.875% Notes due 2028 |
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AZN 28A |
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The Nasdaq Stock Market LLC |
4.000% Notes due 2029 |
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AZN 29 |
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The Nasdaq Stock Market LLC |
1.375% Notes due 2030 |
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AZN 30 |
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The Nasdaq Stock Market LLC |
4.900% Notes due 2030 |
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AZN 30A |
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The Nasdaq Stock Market LLC |
2.250% Notes due 2031 |
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AZN 31 |
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The Nasdaq Stock Market LLC |
4.875% Notes due 2033 |
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AZN 33 |
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The Nasdaq Stock Market LLC |
6.450% Notes due 2037 |
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AZN 37 |
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The Nasdaq Stock Market LLC |
4.000% Notes due 2042 |
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AZN 42 |
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The Nasdaq Stock Market LLC |
4.375% Notes due 2045 |
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AZN 45 |
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The Nasdaq Stock Market LLC |
4.375% Notes due 2048 |
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AZN 48 |
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The Nasdaq Stock Market LLC |
2.125% Notes due 2050 |
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AZN 50 |
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The Nasdaq Stock Market LLC |
3.000% Notes due 2051 |
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AZN 51 |
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The Nasdaq Stock Market LLC |
* Not for trading, but only in connection with the registration of American Depositary Shares representing such Ordinary Shares pursuant to the requirements of the Securities and Exchange Commission.
Securities registered or to be registered pursuant to Section 12(g) of the Act:
None |
(Title of Class) |
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None |
(Title of Class) |
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
The number of outstanding shares of each class of stock of AstraZeneca PLC as of December 31, 2023 was:
Title of Class |
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Number of Shares Outstanding |
Ordinary Shares of 25¢ each: |
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1,550,162,626 |
Redeemable Preference Shares of £1 each: |
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50,000 |
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☒ No ☐
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Yes ☐ No ☒
Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “accelerated filer,” “large accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large Accelerated Filer ☒ |
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Accelerated Filer ☐ |
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Non-accelerated Filer ☐ |
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Emerging growth company ☐ |
If an emerging growth company that prepares its financial statements in accordance with US GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐
† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
US GAAP |
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International Financial Reporting Standards as issued by the International Accounting Standards Board |
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Other ☐ |
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
☐ Item 17 ☐ Item 18
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.
Yes ☐ No ☐
Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the information for the 2023 Form 20-F of AstraZeneca PLC (the “Company”) set out below is being incorporated by reference from AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated and submitted on February 20, 2024.
References below to major headings include all information under such major headings, including subheadings, unless such reference is a reference to a subheading, in which case such reference includes only the information contained under such subheading. Unless the context otherwise requires, “AstraZeneca” or “Group” refers to the Company and its consolidated entities. Other information contained within AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F, including graphs and tabular data, is not included in this Form 20-F unless specifically identified below. Photographs are also not included.
In addition to the information set out below, the information (including tabular data) set forth under the headings “Use of terms” on the inside front cover, “Strategic Report—Financial Review—Measuring performance” on page 60, and the tables on pages 61 to 63, “Additional Information —Trade Marks” on page 231, “—Glossary” on pages 232 to 235 and “—Important information for readers of this Annual Report—Cautionary statement regarding forward-looking statements”, “—Inclusion of Reported performance, Core financial measures and constant exchange rate growth rates”, “—Statements of competitive position, growth rates and sales”, “— AstraZeneca websites”, “—External/third-party websites” and “—Figures” on page 236, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. References herein to AstraZeneca websites, including where a link is provided, are textual references only and information on or accessible through such websites does not form part of and is not incorporated into this Form 20-F dated February 20, 2024. Reference to “audited” information (including graphs and tabular data) set forth under the heading “Corporate Governance—Directors’ Remuneration Report” refers to procedures performed by the Company’s external auditor in accordance with International Standards on Auditing (UK) (‘ISAs (UK)’) and applicable law and does not form part of the “Report of Independent Registered Public Accounting Firm” in Item 18 herein. For the avoidance of doubt, the “Independent auditors’ report to the members of AstraZeneca PLC” on pages 141 to 147 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 does not form part of, and is not incorporated into, this Form 20-F dated February 20, 2024.
PART 1
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
A. Reserved
B. Capitalization and Indebtedness
Not applicable.
C. Reason for the Offer and Use of Proceeds
Not applicable.
3
D. Risk Factors
Operating in the pharmaceutical sector carries various inherent risks and uncertainties that may affect our business. In this section, we describe the risks and uncertainties that we consider material to our business, in that they may have a significant effect on our financial condition, results of operations and/or reputation.
These risks have been categorised consistently with the “Risk Overview—Principal Risks” detailed on pages 56 and 57 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024, each of which are included below (in addition to other risks that we face). We believe that the forward-looking statements about AstraZeneca in this Form 20-F dated February 20, 2024, identified by words such as ‘anticipates’, ‘believes’, ‘expects’ and ‘intends’, are based on reasonable assumptions. However, forward-looking statements involve inherent risks and uncertainties such as those summarised below. They relate to events that may occur in the future, that may be influenced by factors beyond our control and that may have actual outcomes materially different from our expectations. Therefore, other risks, unknown or not currently considered material, could have a material adverse effect on our financial condition or results of operations.
Product pipeline risks |
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Impact |
Failure or delay in the delivery of our pipeline or launch of new medicines | ||
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Our continued success depends on the development and successful launch of innovative new drugs. The development of pharmaceutical product candidates is a complex, risky and lengthy process involving significant resources. A project may fail at any stage of the process due to various factors, including: failure to obtain the required regulatory or marketing approvals, unfavourable clinical efficacy data, safety concerns, failure to demonstrate adequate cost-effective benefits to regulatory authorities and/or payers, and the emergence of competing products. Details of projects that have suffered setbacks or failures during 2023 can be found in the “Strategic Report—Therapy Area Review” on pages 16 to 31 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024. Launch activities may be delayed by a number of factors, including: adverse findings in preclinical or clinical studies, regulatory demands, price negotiation, large-scale natural disasters or global pandemics, competitor activity, and technology transfer. In addition to developing products in-house, we continue to expand our portfolio through licensing arrangements and strategic collaborations which may not ultimately be successful. |
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Failure or delay in development of new product candidates could damage the reputation of our R&D capabilities, and materially adversely affect our future business and results of operations. Delays to launches can lead to excess expenses in the manufacture of pre-launch inventories, marketing materials and sales force training. For the launch of products that are seasonal in nature, delays in regulatory approvals or manufacturing may delay launch to the next season which, in turn, may significantly reduce the return on costs incurred in preparing for the launch for that season. Furthermore, in immuno-oncology in particular, speed to market is critical given the large number of clinical trials being conducted by competitors. Delay of launch can also erode the term of patent exclusivity. Competition from other pharmaceutical companies means that we may have to pay a significant premium over book or market values for our acquisitions. Failure to complete collaborative projects in a timely, cost-effective manner may limit our ability to access a greater portfolio of products, intellectual property (IP), technology and shared expertise. In many cases we make milestone payments in advance of the commercialisation of the products, with no assurance of recouping costs. |
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Failure to meet regulatory or ethical requirements for medicine development or approval | ||
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We are subject to laws and regulations that control our ability to market our pharmaceutical products. Our development programmes must meet many standards to prove our products are safe, effective and of high quality. Health authorities, such as the FDA in the US and the European Medicines Agency in the EU, can refuse to approve our products or require us to conduct additional clinical trials or scientific testing before they will approve them for marketing. Many factors influence health authority decisions to approve or reject a marketing application for a pharmaceutical product. These include advances in science and technology; new laws, regulations and policies; and different standards for evaluating safety and effectiveness. |
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Delays in regulatory approvals could delay our ability to market our products and may adversely affect our revenue. Also, post-approval requirements, including additional clinical trials, could cause increased costs. We seek to manage these risks, but policymaking by governments and health authorities can be unpredictable and unforeseen circumstances, such as public health emergencies, may strain health authority resources and delay the approval of our products. Following approval, a health authority may require us to conduct additional clinical trials or scientific testing to address concerns raised after patients have used our products in the marketplace. New data may impact a product’s approval status or lead to labelling changes that limit the use of a product. |
4
D. Risk Factors
continued
Commercialisation risks |
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Impact |
Failures or delays in the quality or execution of the Group’s commercial strategies | ||
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Maximising the commercial potential of our new products underpins the success of our strategy and the delivery of our short- and medium-term targets. We may ultimately be unable to achieve commercial success for various reasons, including: > difficulties in manufacturing sufficient quantities of the product > any price control measures imposed by governments and healthcare authorities > patient access to healthcare > diagnosis rates > erosion of IP rights > failure to show a differentiated product profile > changes in prescribing habits. The ability to successfully carry out business in emerging markets can be more challenging than in established markets. Such challenges may include: > volatility in economic or political climates > inadequate protection against crime (including counterfeiting, corruption and fraud) > inadvertent breaches of local and international law. |
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Failure to execute our commercial strategies or achieve the level of sales anticipated for a medicine could materially adversely impact our business or results of operations. Failure to leverage potential opportunities or appropriately manage risks in emerging markets may materially adversely affect our reputation, business or results of operations. |
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Pricing affordability, access and competitive pressures | ||
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Appropriate pricing, reimbursement and policy frameworks enable us to contribute significantly to patients, public health and health practice transformation. The global economic, political and social pressures are creating an ever more challenging environment in which we operate. As a result of global financial pressures there is increased evidence of cost containment measures including: > drug pricing system reforms such as the Inflation Reduction Act (IRA) in the US > changes to reference pricing rules impacting prices in some markets > expedited approval of generic drugs and introduction of new laws, regulations and policies. |
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Deterioration of, or lack of improvement in, socio-economic conditions could adversely affect supply and/or distribution in affected countries and the ability or willingness of customers to purchase our medicines, putting pressure on price and/or volumes. This could adversely affect our business or results of operations, for example, those health systems most severely impacted by downturn may seek alternative ways to settle their debts at a discount. Other customers may cease to trade, which may result in losses from writing off debts or a reduction in demand for products. Across the industry, a new government-run drug price-setting programme in the US could reduce the value of certain products sooner than planned and impact the R&D pipeline as companies seek to avoid investing in lower yield products. |
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D. Risk Factors
continued
Supply chain and business execution risks |
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Impact |
Failure to maintain supply of compliant, quality medicines | ||
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We may experience challenges, delays or interruptions in the manufacturing and supply of our products for various reasons, including: > Supply shortages or delays in construction of facilities to support future demand of our products caused by significant unforecasted demand growth or supply chain disruptions (e.g. natural disasters, climate impacts, COVID 19,conflict or political unrest). > The inability to supply products due to a product quality failure or regulatory compliance action such as licence withdrawal, product recall or change of regulatory standards (e.g. nitrosamines, where regulators have been introducing new limits/expectations for regulatory filings). It is necessary for us to meet all regulations, including compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) and comparable regulatory dossier conditions of approval in all countries in which our products are licensed, manufactured or sold. We rely significantly on third parties for the timely supply of goods (e.g. active ingredients and packaging components), many of which are difficult to substitute in a timely manner or at all. |
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Supply chain difficulties may result in product shortages, which could lead to lost Product Sales and materially affect our reputation and results of operations. Failure to comply with all manufacturing regulations can result in negative regulatory inspection findings that could lead to the halt of manufacturing, and/or product seizure, debarment or recalls which could have an adverse effect on our business, financial condition and results of operations. In the event of insolvency of third-party suppliers, it would be difficult to substitute in a timely manner or at all. |
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D. Risk Factors
continued
Illegal trade in the Group’s medicines | ||
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The illegal trade of pharmaceutical products, including counterfeiting, tampering, theft and illegal diversion (where products are found in a market where we did not send them and where they are not approved to be sold) may lead to a loss of public confidence in the integrity of medicines. |
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The incidence of illegal trade could materially adversely affect our reputation, financial performance and pose a direct risk to patient safety. In addition, concern about this issue may cause some patients to stop taking their medicines, with consequential risks to their health. If we are found liable for breaches in our supply chains, authorities may take action, financial or otherwise, that could restrict the distribution of our products. |
Reliance on third-party goods and services | ||
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A significant proportion of AstraZeneca’s annual costs relates to spend with third-party suppliers. The level of spend supports the length of our value chain from discovery to manufacture and commercialisation of our medicines. Many of our business-critical operations are outsourced to third-party providers. We are, therefore, heavily reliant on these third parties to get medicines to patients, comply with applicable laws and regulations, while also ensuring prudent use of AstraZeneca financial resources. |
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Failure to successfully secure, onboard and manage outsourced services, particularly with inflationary pressures increasing, or the failure of outsourced providers to deliver timely services, and to the required level of quality, could materially adversely affect our reputation, our financial condition and operating results as well as our ability to deliver medicines to patients. Failure to effectively manage third-party suppliers when external factors, including geopolitical tensions, or raw materials and components shortages, place increased pressure on AstraZeneca’s ability to purchase goods and services may lead to major business disruption. Any breach of security, whether physical, cyber or data related, or failure of these third parties to operate in a way that is consistent with laws or regulations, may lead to regulatory penalties, materially affect the results of operations and adversely impact our reputation. |
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Failure in information technology or cybersecurity | ||
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IT systems enable critical business functions. Critical business processes and functions are increasingly dependent on partner and vendor IT stability and data integrity. IT systems provide our workforce with continuous access to collaboration environments, global communications channels, applications and data. High availability IT systems remain a business imperative. In addition to availability and reliability, IT systems must comply with provisions specified in data security, privacy and individual protection laws. Data is a commodity that we prioritise continued access to and protection of. Data is often characterised as strictly confidential information. Examples of strictly confidential data include clinical trial records, personal information, IP, R&D data, and compliance information. AstraZeneca’s IT systems and data are potentially vulnerable to service interruptions and security breaches via attacks by malicious third parties or intentional or inadvertent actions by our employees or vendors. Attempts to exploit AstraZeneca are increasingly sophisticated. Threat actors include organised criminal groups, ‘hacktivists’, nation states, employees and others. The internet is our primary critical business transaction channel. Internet availability is increasingly at risk due to geopolitical tensions and conflict. Privacy legislation includes obligations to report data protection breaches to regulators and affected individuals within expedited timeframes. |
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Disruption to these IT systems and/or the internet (including breaches of data security or cybersecurity, failure to integrate new and existing IT systems) or failure to comply with additional requirements under applicable laws, could harm our reputation and materially adversely affect our financial condition or results of operations. While we invest heavily in the protection of our data and IT, we may be unable to prevent hardware or software failures or breaches which could result in disclosure of confidential information, damage to our reputation, regulatory penalties or sanctions, or financial loss. The inability to back-up and restore data effectively could lead to permanent loss of data that could, in turn, result in non-compliance with applicable laws and regulations and otherwise harm our business. Data loss could lead to public disclosure of confidential information which may damage our reputation, materially affect our business or results of operations, and expose us to legal risks and/or additional legal obligations. Public disclosure of sensitive information could materially adversely affect our reputation and business or operations results. Cybersecurity insurance coverage limits may not protect against any future claim or claim proceeds may be delayed. Failure to comply with regulatory disclosure requirements could cause reputational damage and a loss of public trust. |
7
D. Risk Factors
continued
Failure of critical processes | ||
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Unexpected events and/or events beyond our control could result in the failure of critical processes within the Group or at third parties on whom we are reliant. The business faces threats to business continuity from many directions. Examples of material threats include: > Disruption to our business or the global markets if there is instability in a particular geographic region, including as a result of war, terrorism, pandemics, armed conflicts, riots, unstable governments, civil insurrection or social unrest. > Natural disasters in areas of the world prone to extreme weather events, which may increase in frequency or severity as a result of climate change. > Cyber threats similar to those detailed in the ‘Failure in information technology or cybersecurity’ section above. |
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Crystallisation of such material threats may heighten certain other risks, such as those relating to the delivery of the pipeline, launch of new medicines, or the manufacture and supply of medicines, and may lead to loss of revenue and have a materially adverse impact on our financial results. |
Failure to collect and manage data in line with legal and regulatory requirements and strategic objectives | ||
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Data is increasingly recognised as being AstraZeneca’s most valuable commodity. There is an increasing range of legislative and regulatory requirements to manage data across all countries where we conduct business, these may impact certain types of data such as personal data, the way that we conduct business such as restricting the movement of data between countries or jurisdictional regions or how we make use of new technological capabilities such as artificial intelligence (AI). In addition, geopolitical changes may require changes to how AstraZeneca manages data. Beyond legal and regulatory requirements, achieving strategic objectives will require good management of data across the enterprise. As our organisation increasingly relies on data, including sensitive data relating to health and genomics, a failure to properly understand personal and collective accountabilities for managing data to maximise its value, or failure to address data risks will reduce our ability to execute at pace and deliver strategic objectives. AI technologies present significant opportunities and risks to our business. Harnessing AI’s transformative potential may enable AstraZeneca to speed up the discovery and development of new drugs, optimise our manufacturing processes, drive efficiencies and productivity, and accelerate our growth. Failure to exploit these opportunities may put AstraZeneca at a competitive disadvantage. AstraZeneca is investing significant resources into AI experimentation, development, and deployment across many parts of our business. As we scale our use of AI, it is possible not all investments will succeed. AI technologies may exacerbate existing risks, like those risks associated with data privacy, cybersecurity and IP. AI also introduces new risks due to the autonomous nature of the technology, the ease at which AI-enabled decision making can be scaled up, and the commercial pressures to adopt AI. AI systems can amplify biased and discriminatory decision making, perform unreliably and malfunction, generate insights which are difficult to interpret and explain, and cause direct harm to individuals or groups. These risks may become more significant as we increasingly utilise AI to inform, augment and automate decision making and processes in sensitive areas (e.g. clinical trials, medical decision making). The adoption and exploitation of AI is occurring under the backdrop of intense global media scrutiny, heightened political attention and low levels of public trust and understanding. There is also a range of new AI regulations being adopted and implemented worldwide, including in the EU, China and the US. |
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Despite taking measures designed to ensure compliance with applicable privacy- and AI-related laws and regulations by our personnel and our third parties, non-compliance has occurred and may occur again in the future. If future instances of non-compliance are deemed significant, these may attract material regulatory sanctions or fines and corresponding reputational damage, orders to stop certain processing of personal data, or legal action on behalf of impacted individuals. Further, failure to protect personal data could lead to a competitive disadvantage, loss of trust from our stakeholders, including patients, and prevent us from delivering our strategic objectives. If the scope of data-related laws is expanded or if the interpretation or enforcement of existing laws change or new privacy laws are implemented, AstraZeneca and its third-party vendors may be required to change their business practices or data processing practices and policies. This may lead to substantial compliance-related costs or materially adversely impact our business and financial condition. Our failure to use AI technologies in a way that maintains trust, quality and control in our business activities would pose reputational, legal, regulatory and financial risks to AstraZeneca. Investments in AI may not realise the benefits that were anticipated. |
8
D. Risk Factors
continued
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Failure to attract, develop, engage and retain a diverse, talented and capable workforce | ||
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We rely heavily on recruiting and retaining talented employees with a diverse range of skills and capabilities to meet our strategic objectives. Externally there is intense competition for well-qualified individuals, as the supply of people with certain skills or in specific geographic regions may be limited. Ensuring our employees are continually developed and engaged with strategic objectives embeds commitment across the workforce. |
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The inability to attract and retain highly skilled personnel may weaken our succession plans for critical positions, impact the implementation of our strategic objectives and ultimately result in the failure of our business operations. Failure to develop and engage our workforce could result in business disruption, a loss of productivity and higher turnover rates, all of which could materially adversely affect our business. Focus in 2024 will be to look at our global footprint to ensure we are best positioned to support science and the business towards the 2030 Bold Ambition. |
Legal, regulatory and compliance risks |
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Impact |
Failure to meet regulatory or ethical expectations on environmental impact, including climate change | ||
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Environmental issues will become more material as healthcare systems embrace net-zero climate targets. Our environmental targets and performance will have increased scrutiny by investors, governments and non-governmental organisations. Environmental considerations are becoming embedded in the public procurement of goods and services, including medicinal products and devices. Specific materials used to manufacture medicines, or used as excipients or propellants, are coming under increased regulation and may be subject to time-limited exemptions or potential phase-out. The physical impacts of climate change could impact the resilience of our business operations and supply chain. |
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Investors are increasingly focusing on environmental issues. We continue to see an increased requirement to quantify the impact of specific environmental issues and to disclose our strategy, targets and performance. Failure to maximise our environmental sustainability credentials could expose us to increased regulatory risk and put us at a commercial disadvantage relative to our peers. This could adversely impact our financial results and lead to reputational damage. Failure to proactively manage the physical risks associated with climate change could impact the resilience of our operations and supply chain. This could result in supply interruptions, loss of stock and adversely impact our financial results. |
Safety and efficacy of marketed medicines is questioned | ||
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Our ability to accurately assess, prior to launch, the eventual safety or efficacy of a new product once in broader clinical use can only be based on data available at that time, which is inherently limited due to relatively short periods of product testing and relatively small clinical study patient samples. Any unforeseen safety concerns or adverse events relating to our products, or failure to comply with laws, rules and regulations relating to provision of appropriate warnings concerning the dangers and risks of our products that result in injuries, could expose us to large product liability claims, settlements and awards, particularly in the US. Adverse publicity relating to the safety of a product, or of other competing products, may increase the risk of product liability claims. Details of material product liability litigation matters can be found in “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024. |
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Serious safety concerns or adverse events relating to our products could lead to product recalls, seizures, loss of product approvals, declining sales and interruption of supply, and could materially adversely impact patient access, our reputation and financial revenues. Significant product liability claims could also arise which could be costly, divert management attention, or damage our reputation and demand for our products. Unfavourable resolution of such current and similar future product liability claims could subject us to enhanced damages, consumer fraud and/or other claims, including civil and criminal governmental actions. This could require us to make significant provisions in our accounts relating to legal proceedings and could materially adversely affect our financial condition or results of operations, particularly where such circumstances are not covered by insurance. |
9
D. Risk Factors
continued
Adverse outcome of litigation and/or governmental investigations | ||
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Our business is subject to a wide range of laws and regulations around the world. We have been, and may continue to be, subject to various legal proceedings and governmental investigations. Actual or perceived failure to comply with laws or regulations may result in AstraZeneca and/or its employees being investigated by government agencies and authorities and/ or in civil legal proceedings. Relevant authorities have wide-ranging administrative powers to deal with any failure to comply with laws, regulations or continuing regulatory oversight, and this could affect us, whether such failure is our own or that of our contractors or external partners. In particular, the manufacturing, marketing, exportation, promotional, clinical, pharmacovigilance and pricing practices of pharmaceutical manufacturers, as well as manufacturer interaction with regulatory agencies, purchasers, prescribers and patients, are subject to extensive regulation, litigation and governmental investigation. Moreover, such laws, rules and regulations are subject to change. Details of material litigations and governmental investigations can be found in “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024. |
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Many companies, including AstraZeneca, have been subject to legal claims asserted by federal and state governmental authorities and private payers and consumers, which have resulted in substantial expense and other significant consequences. Governmental investigations or proceedings could result in civil or criminal sanctions and/or the payment of fines or damages. Civil litigation, particularly in the US, is inherently unpredictable, and unexpectedly high awards for damages can result from an adverse result. In many cases, litigation adversaries may claim enhanced damages in extremely high amounts. Government investigations, litigations, and other legal proceedings, regardless of the outcome, could be costly, divert management attention, or damage our reputation and demand for our products. Unfavourable resolutions to current and similar future proceedings against us that could subject us to criminal liability, fines, penalties or other monetary or non-monetary remedies, including enhanced damages, require us to make significant provisions in our accounts relating to legal proceedings and could materially adversely affect our business or results of operations. |
IP risks related to our products | ||
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IP protection provides the foundation for continued investment in developing innovative medicines to improve patient health. However, the pharmaceutical industry is experiencing pressure from governments and other healthcare payers to impose limits on IP protections in an effort to manage healthcare costs. Additionally, policymakers are progressively leveraging regulations to expedite the approval of generic drugs and encourage generic drug utilisation. These policies may drive accelerated utilisation of generic alternatives to our products following expiry or loss of our IP rights. We also recognise increasing use of compulsory licensing in some countries in which we operate. We are subject to numerous patent challenges relating to various products or processes and assertions of non-infringement of our patents. A loss in any of these challenges could result in loss of patent protection on the covered product and a risk to the revenue generated by the product. We also face the risk that our products may be found to infringe patents owned or licensed by third parties and we may be subject to monetary damages or compelled to cease sales of the infringing product, resulting in a potential risk to revenue. These challenges threaten the value of our investment in pharmaceutical development. Details of material patent litigation matters can be found in “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024. |
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If we are unable to obtain, defend and enforce our IP, we may experience accelerated and intensified competition. Also, if our products are found to infringe a third-party patent, we may be subject to monetary damages or compelled to cease sales of the infringing product. These negative outcomes could have an adverse material impact on our financial results. |
10
D. Risk Factors
continued
Economic and financial risks |
|
Impact |
Failure to achieve strategic plans or meet targets or expectations | ||
|
|
|
When we communicate our business strategy, targets or performance expectations, all such statements are forward-looking and based on assumptions and judgements, all of which are subject to significant inherent risks and uncertainties. |
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To achieve our strategic objectives, we must continue to develop commercially viable new products and successfully integrate new organisations we have acquired. There can be no guarantee that our strategy or expectations will materialise. Any failure to successfully implement our business strategy may frustrate the achievement of our financial targets, which may therefore materially damage our brand, business, financial position or results of operations. |
|
|
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Geopolitical and/or macroeconomic volatility disrupts the operation of our global business | ||
|
|
|
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Operating in more than 100 countries, we are subject to political, socio-economic and financial factors around the world. A sustained global economic downturn may adversely impact financial markets and/or exacerbate pressure from governments and other healthcare payers on medicine prices and other cost control measures in order to limit healthcare spending. Geopolitical tensions may lead to the imposition or escalation of trade controls, tariffs, taxes or other restrictions to market access which may increase our costs or reduce revenues. |
|
A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for medicines and our ability to raise additional capital when needed or on favourable terms, if at all. A weak or declining economy could strain our suppliers, possibly resulting in supply disruption, or cause delays in payments for our services by third-party payers. Measures taken to limit healthcare spending may lead to lower than anticipated rates of growth in some markets and an adverse impact on revenues and profitability. Any escalation in barriers to the global free flow of medicines is likely to increase costs to serve affected markets which may lead to downward pressure on margins. While the introduction of severe sanctions is unlikely in relation to medicines, it could occur if matters escalate significantly and could impact processes for the commercialisation of medicines and levels of sales in affected markets. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business. |
Failure in financial control or the occurrence of fraud | ||
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|
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Effective internal controls assist in the provision of reliable Financial Statements and the detection and prevention of fraud. Testing of internal controls provides only limited assurance over the accuracy of Financial Statements and may not prevent or detect misstatements or fraud. |
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Significant resources may be required to remediate any deficiency in internal controls. Any such deficiency may trigger related investigations and may result in fines being levied against individual directors or officers. Serious fraud may lead to prosecution of senior management. Any of the foregoing could adversely affect our financial results and lead to reputational damage. |
11
D. Risk Factors
continued
Unexpected deterioration in the Group’s financial position | ||
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|
|
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Movements in exchange rates against the US dollar, our reporting currency, impact our reported results. The key currencies of Product Sales and costs are: US dollar, Chinese renminbi, euro, Japanese yen, Swedish krona and pound sterling. Most of our cash is invested in AAA credit-rated institutional money market funds, fixed income securities issued by government, financial and non-financial entities and collateralised and non-collateralised bank deposits. Our credit exposure is a mix of US, EU and rest of world default risk across these institutions. We invest in many projects in an effort to develop a successful portfolio of approved products. Our Consolidated Statement of Financial Position therefore contains significant investments in intangible assets, including goodwill. Our ability to realise value on these investments depends on regulatory approvals, market acceptance, competition, and legal developments. Our defined benefit post-retirement obligations (primarily in the UK and Sweden) can materially change in value but are largely backed by assets invested in growth and liability hedging portfolios, which hedge some of the risks inherent in liability valuations. Although we maintain relevant insurance coverage for risks arising within the Group, we may not be able to maintain our insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. Tax law is complex, leading to the risk of different interpretations. Revenue authorities can make conflicting claims to the profits taxed in individual countries leading to double taxation and the potential for fines and penalties. Tax laws can change following action by international bodies such as the Organisation for Economic Co-operation and Development (OECD) or individual governments. |
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Foreign exchange rate movements may materially adversely affect our financial condition or results of operations. In a sustained economic downturn, such institutions may cease to trade and there can be no guarantee that we will be able to access the full value of our investments. We expect that some of our intangible assets will become impaired in the future. Impairment losses may materially adversely affect our financial condition or results of operations. Solvency levels could fall, leading to higher contributions if there are: falls in assets; increases in liability valuations (from falls in bond yields, increases in inflation or lower mortality); or changes in regulations. As liability valuation risks are hedged to a material level, significant collateral may need to be posted, which in extreme circumstances could lead to a short-term liquidity risk in some pension schemes and a request to the Group to provide temporary liquidity. Uninsured losses, or those where an insurer denies coverage, could materially adversely affect our financial condition. The resolution of tax disputes can result in incremental tax costs, a reallocation of profits or losses between jurisdictions, or even double taxation, fines and penalties. They are costly, divert management attention and may adversely affect our reputation. If tax treaties are withdrawn or amended, or Competent Authorities are unable to reach an agreement that eliminates double taxation, this could materially adversely affect our financial position. For details of our financial risk management policies, see “Strategic Report—Financial Review—Financial risk management” on page 71 and for details of current tax disputes, see “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024. Changes in tax regimes could result in a material impact on the Group’s cash tax liabilities and tax charge, resulting in either an increase or a reduction in financial results. |
12
ITEM 4. INFORMATION ON THE COMPANY
A. History and Development of the Company
AstraZeneca PLC was incorporated in England and Wales on June 17, 1992 under the Companies Act 1985. It is a public limited company domiciled in the UK. The Company’s registered number is 2723534 and its registered office is at 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, UK (Tel: +44 (0)20 3749 5000). From February 1993 until April 1999, the Company was called Zeneca Group PLC. On April 6, 1999, the Company changed its name to AstraZeneca PLC.
The Company was formed when the pharmaceutical, agrochemical and specialty chemical businesses of Imperial Chemical Industries PLC were demerged in 1993. In 1999, the Company sold the specialty chemical business. Also in 1999, the Company merged with Astra of Sweden. In 2000, it demerged the agrochemical business and merged it with the similar business of Novartis to form a new company called Syngenta AG. In 2007, the Group acquired MedImmune, a biologics and vaccines business based in the US. In 2021, the Group acquired Alexion, a rare disease business based in the US.
In 1999, in connection with the merger between Astra and Zeneca, the Company’s share capital was redenominated in US dollars. On 6 April 1999, Zeneca shares were cancelled and US dollar shares issued, credited as fully paid on the basis of one dollar share for each Zeneca share then held.
This was achieved by a reduction of capital under section 135 of the Companies Act 1985. Upon the reduction of capital becoming effective, all issued and unissued Zeneca shares were cancelled and the sum arising as a result of the share cancellation credited to a special reserve, which was converted into US dollars at the rate of exchange prevailing on the record date. This US dollar reserve was then applied in paying up, at par, newly created US dollar shares.
At the same time as the US dollar shares were issued, the Company issued 50,000 Redeemable Preference Shares for cash, at par. The Redeemable Preference Shares carry limited class voting rights, no dividend rights and are capable of redemption, at par, at the option of the Company on the giving of seven days’ written notice to the registered holder of the Redeemable Preference Shares.
A total of 826 million Ordinary Shares were issued to Astra shareholders who accepted the merger offer before the final closing date, 21 May 1999. The Company received acceptances from Astra shareholders representing 99.6% of Astra’s shares and the remaining 0.4% was acquired in 2000, for cash.
In 2021, in connection with the acquisition of Alexion, a total of 236 million Ordinary Shares (the majority of which were represented by new AstraZeneca ADRs) were issued to Alexion shareholders in part consideration for the acquisition.
The information (including tabular data) set forth under the headings “Strategic Report—Financial Review—Collaboration Revenue” on pages 65 to 66, “Strategic Report—Financial Review—Restructuring” on page 67, “Strategic Report—Financial Review—Acquisitions treated as Business combinations” and “—Acquisitions treated as asset acquisitions” on page 69, “Strategic Report—Financial Review—Investments, divestments and capital expenditure” on page 70, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Board Leadership and Company Purpose” on page 81 and “Additional Information—Important information for readers of this Annual Report—AstraZeneca websites” on page 236, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. Additionally, the information set forth under the heading “Strategic Report—Financial Review” on pages 60 to 76 of AstraZeneca’s “Annual Report and Form 20-F Information 2022” included as exhibit 15.1 to the Form 20-F dated February 21, 2023 is incorporated herein by reference.
The United States Securities and Exchange Commission (the “SEC”) maintains a website at www.sec.gov which contains in electronic form each of the reports and other information that we have filed electronically with the SEC.
13
B. Business Overview
The information (including graphs and tabular data) set forth under the headings “Strategic Report—AstraZeneca at a Glance” on page 5, “Strategic Report—Chair’s Statement” on page 2, “Strategic Report—Chief Executive Officer’s Review” on pages 3 to 4, “Strategic Report—Science can…” on page 6, “Strategic Report—Healthcare in a Changing World” on pages 7 to 9, “Strategic Report—Our Purpose, Values and Business Model” on pages 10 to 11, “Strategic Report—Our strategy and Key Performance Indicators” on pages 12 to 15, “Strategic Report—Therapy Area Review” on pages 16 to 31, “Strategic Report—Business Review” on pages 32 to 49, “Strategic Report—Task Force on Climate-related Financial Disclosures Summary Statement” on pages 51 to 53, “Strategic Report—Risk Overview—Managing risk”, “—Risk Overview—Emerging risks”, “—Risk Overview—Climate risk”, “—Risk Overview—Cybersecurity Risk” on page 54, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Global Compliance and Group Internal Audit (GIA)” on page 83, “Corporate Governance—Corporate Governance Report—Principal Decisions—Acquisitions and collaborations to strengthen pipeline” on page 87, “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161, “Financial Statements—Notes to the Group Financial Statements—Note 6—Segment information” on page 167 to 169, “Additional Information—Sustainability: supplementary information” on page 230, and “Additional Information—Important information for readers of this Annual Report—Statements of competitive position, growth rates and sales” on page 236, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
14
Development Pipeline as of February 8, 2024
This section sets out AstraZeneca-sponsored or -directed trial New Molecular Entities (NMEs) and significant indications.
First major market regulatory submission date and submission status is provided for assets in Phase III or beyond. As disclosure of compound information is balanced by the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed at this time.
Key:
PP = Partnered product
Phase I
Compound |
|
Mechanism |
|
Additional |
|
Area Under Investigation |
|
Oncology |
|
|
|
|
|
|
|
AZD0305 |
|
GPRC5D ADC |
|
|
|
relapsed/refractory multiple myeloma |
|
AZD0486 |
|
CD19-CD3 TCE |
|
|
|
R/R B-cell non-Hodgkin lymphoma |
|
AZD0486 |
|
CD19-CD3 TCE |
|
|
|
B-cell acute lymphoblastic leukaemia |
|
AZD1390 |
|
ATM inhibitor |
|
|
|
glioblastoma |
|
AZD3470 |
|
PRMT5 inhibitor |
|
|
|
classic Hodgkin lymphoma, solid tumours |
|
AZD5335 |
|
anti-folate receptor alpha topoisomerase 1 inhibitor ADC |
|
|
|
ovarian cancer, lung adenocarcinoma |
|
AZD5851 |
|
GPC3 CAR-T |
|
|
|
hepatocellular carcinoma |
|
AZD5863 |
|
CLDN18.2 x CD3 bi-specific antibody (HBM7022) |
|
|
|
solid tumours |
|
AZD6422 |
|
CLDN18.2 CAR-T |
|
|
|
solid tumours |
|
AZD8421 |
|
CDK2 inhibitor |
|
|
|
solid tumours |
|
AZD9592 |
|
EGFR/cMET |
|
|
|
solid tumours |
|
AZD9829 |
|
CD123 TOP1i ADC |
|
|
|
acute myeloid leukemia, myelodysplastic syndromes |
|
NT-125 |
|
autologous, fully-individualised, multi-specific TCR-T targeting neoantigens |
|
|
|
solid tumours |
|
NT-175 |
|
TGFBR2 KO armoured TCR-T targeting TP53 R175H/HLA-A*02:01 |
|
|
|
solid tumours |
|
volrustomig + lenvatinib |
|
PD-1/CTLA-4 bispecific mAb + VEGF |
|
|
|
advanced renal cell carcinoma |
|
CVRM |
|
|
|
|
|
|
|
AZD2373 |
|
podocyte health |
|
|
|
nephropathy |
|
AZD2389 |
|
anti-fibrotic mechanism |
|
|
|
metabolic dysfunction-associated steatohepatitis |
|
AZD4144 |
|
inflammation modulator |
|
|
|
cardiorenal disease |
|
AZD5462 |
|
RXFP1 agonist |
|
(PP) |
|
heart failure |
|
AZD6234 |
|
peptide |
|
|
|
obesity with related comorbidities |
|
AZD7503 |
|
ASO |
|
|
|
non-alcoholic steatohepatitis |
|
AZD9550 |
|
GLP-1R glucagon dual agonist |
|
|
|
non-alcoholic steatohepatitis |
|
Respiratory & Immunology |
|
|
|
|
|
|
|
AZD1163 |
|
bispecific antibody |
|
|
|
rheumatoid arthritis |
|
AZD5055 |
|
porcupine inhibitor |
|
|
|
idiopathic pulmonary fibrosis |
|
AZD6793 |
|
IRAK4 inhibitor |
|
|
|
inflammatory diseases |
|
AZD6912 |
|
siRNA |
|
|
|
rheumatoid arthritis |
|
AZD7798 |
|
humanised monoclonal antibody targets T cells subset |
|
|
|
Crohn’s disease |
|
AZD8630 |
|
inhaled TSLP FAb |
|
(PP) |
|
asthma |
|
Other Medicines |
|
|
|
|
|
|
|
AZD4041 |
|
orexin 1 receptor antagonist |
|
(PP) |
|
opioid use disorder |
|
MEDI0618 |
|
PAR2 antagonist mAb |
|
Phase I/IIa |
|
migraine |
|
MEDI1814 |
|
amyloid beta mAb |
|
(PP) |
|
Alzheimer’s disease |
|
Rare Disease |
|
|
|
|
|
|
|
ALXN1910 |
|
next generation TNSALP ERT |
|
|
|
bone metabolism |
|
ALXN1920 |
|
kidney-targeted factor H fusion protein |
|
|
|
nephrology |
|
ALXN2030 |
|
siRNA targeting complement C3 |
|
|
|
nephrology |
|
ALXN2080 |
|
oral factor D inhibitor |
|
|
|
healthy volunteers |
|
Vaccine and Immune therapies |
|
|
|
|
|
|
|
COVID mRNA VLP vaccine |
|
Vaccine |
|
|
|
COVID-19 |
|
15
Phase II
Compound |
|
Mechanism |
|
Additional |
|
Area Under Investigation |
|
Oncology |
|
|
|
|
|
|
|
AZD0171 + Imfinzi + CTx |
|
anti-LIF mAb + PD-L1 mAb + CTx |
|
|
|
1st-line metastatic pancreatic ductal adenocarcinoma |
|
AZD0901 |
|
CLDN18.2 MMAE ADC |
|
|
|
solid tumours |
|
AZD8205 |
|
B7-H4 targeting ADC |
|
|
|
solid tumours |
|
AZD9574 |
|
PARP inhibitor |
|
|
|
advanced solid malignancies |
|
camizestrant |
|
selective estrogen receptor degrader |
|
|
|
estrogen receptor +ve breast cancer |
|
ceralasertib |
|
ATR inhibitor |
|
|
|
solid tumours |
|
IPH5201 + Imfinzi |
|
CD39 + PD-L1 |
|
(PP) |
|
neoadjuvant/adjuvant NSCLC |
|
rilvegostomig ARTEMIDE-01 |
|
PD-1/TIGIT bispecific mAb |
|
(PP) |
|
solid tumours |
|
sabestomig |
|
PD-1/TIM3 bispecific mAb |
|
solid tumours (Phase II), haematological malignancies (Phase I) |
|
solid tumours, haematological malignancies |
|
saruparib |
|
PARP1Sel |
|
|
|
solid tumours |
|
volrustomig |
|
PD-1/CTLA-4 bispecific mAb |
|
|
|
solid tumours |
|
CVRM |
|
|
|
|
|
|
|
AZD0780 |
|
PCSK9 |
|
|
|
dyslipidaemia |
|
AZD2693 |
|
NASH resolution |
|
|
|
non-alcoholic steatohepatitis |
|
AZD3427 |
|
relaxin mimetic |
|
|
|
heart failure |
|
balcinrenone/dapagliflozin |
|
MR modulator + SGLT2 inhibitor |
|
|
|
heart failure with CKD |
|
MEDI6570 |
|
LOX-1 mAb |
|
|
|
cardiovascular disease |
|
mitiperstat |
|
myeloperoxidase |
|
|
|
heart failure with a preserved ejection fraction/NASH |
|
zibotentan/dapagliflozin |
|
endothelin A receptor antagonist/SGLT2 inhibitor |
|
|
|
liver cirrhosis |
|
Respiratory & Immunology |
|
|
|
|
|
|
|
atuliflapon |
|
FLAP inhibitor |
|
|
|
asthma |
|
AZD4604 |
|
inhaled JAK1 inhibitor |
|
|
|
asthma |
|
mitiperstat |
|
myeloperoxidase |
|
|
|
COPD |
|
tozorakimab FRONTIER 3 |
|
IL-33 mAb |
|
|
|
asthma |
|
Other Medicines |
|
|
|
|
|
|
|
MEDI1341 |
|
alpha synuclein mAb |
|
(PP) |
|
multiple system atrophy/Parkinson’s disease |
|
MEDI7352 |
|
NGF/TNF bispecific mAb |
|
|
|
osteoarthritis pain and painful diabetic neuropathy |
|
Rare Disease |
|
|
|
|
|
|
|
vemircopan |
|
oral factor D inhibitor |
|
|
|
generalised myasthenia gravis |
|
vemircopan |
|
oral factor D inhibitor |
|
|
|
proliferative lupus nephritis or immunoglobulin A nephropathy |
|
Voydeya (danicopan) |
|
oral factor D inhibitor |
|
|
|
geographic atrophy |
|
16
Phase III/Pivotal Phase II/Registration (listed until launch in all applicable major markets)
Compound |
|
Mechanism |
|
Area Under |
|
Additional |
|
Estimated |
|
Oncology |
|
|
|
|
|
|
|
|
|
camizestrant + CDK4/6i SERENA-6 |
|
selective estrogen receptor degrader + CDK4/6 inhibitors |
|
1st-line HR+ HER2- ESR1m breast cancer |
|
|
|
2025 |
|
camizestrant +palbociclib SERENA-4 |
|
selective estrogen receptor degrader + CDK4/6 inhibitor |
|
1st-line HR+ HER2- breast cancer |
|
|
|
2025 |
|
camizestrant CAMBRIA-1 |
|
selective estrogen receptor degrader |
|
HR+ HER2- extended adjuvant breast cancer |
|
|
|
>2025 |
|
camizestrant CAMBRIA-2 |
|
selective estrogen receptor degrader |
|
ER+/HER2- early breast cancer |
|
|
|
>2025 |
|
ceralasertib +Imfinzi LATIFY |
|
ATR inhibitor + PDL-1 mAb |
|
NSCLC |
|
|
|
>2025 |
|
datopotamab deruxtecan AVANZAR |
|
TROP2 ADC |
|
1L NSCLC, squamous and non-squamous 1L NSCLC, TROP2 BM+ |
|
(PP) |
|
2025 |
|
datopotamab deruxtecan TROPION-Breast01 |
|
TROP2 ADC |
|
2-3L HR+ HER2- breast cancer |
|
(PP) |
|
H1 2024 |
|
datopotamab deruxtecan TROPION-Breast02 |
|
TROP2 ADC |
|
1st-line triple negative breast cancer |
|
(PP) |
|
2025 |
|
datopotamab deruxtecan TROPION-Breast03 |
|
TROP2 ADC |
|
adjuvant residual disease triple negative breast cancer |
|
(PP) |
|
>2025 |
|
datopotamab deruxtecan TROPION-Breast04 |
|
TROP2 ADC |
|
neoadjuvant/adjuvant triple negative or HR-low/HER2-negative breast cancer |
|
(PP) |
|
>2025 |
|
datopotamab deruxtecan TROPION-Breast05 |
|
TROP2 ADC |
|
1L PD-L1+ triple negative breast cancer |
|
(PP) |
|
>2025 |
|
datopotamab deruxtecan TROPION-Lung01 |
|
TROP2 ADC |
|
2L+ NSCLC with or without actionable genomic alterations |
|
(PP) |
|
H1 2024 |
|
datopotamab deruxtecan TROPION-Lung07 |
|
TROP 2 ADC |
|
1L NSCLC PD-L1 <50% non-squamous |
|
(PP) |
|
>2025 |
|
datopotamab deruxtecan TROPION-Lung08 |
|
TROP2 ADC |
|
1L metastatic NSCLC without actionable genomic alterations and PD-L1 TPS ≥50 |
% |
(PP) |
|
2025 |
|
Imfinzi + Imjudo HIMALAYA |
|
PD-L1 mAb + CTLA-4 mAb |
|
1st-line hepatocellular carcinoma |
|
(PP) |
|
Launched |
|
Imfinzi +/- oleclumab +/- monalizumab PACIFIC-9 |
|
PD-L1 + NKG2A or PD-L1 + CD73 |
|
unresectable Stage III NSCLC |
|
(PP) |
|
>2025 |
|
rilvegostomig ARTEMIDEBiliary01 |
|
PD-1/TIGIT bispecific mAb |
|
adjuvant biliary tract cancer |
|
(PP) |
|
>2025 |
|
saruparib EvoPAR-Prostate01 |
|
PARP1Sel |
|
metastatic castration-sensitive prostate cancer |
|
|
|
>2025 |
|
Truqap (capivasertib) + Faslodex CAPItello-291 |
|
AKT inhibitor + fulvestrant |
|
2nd-line and beyond in aromatase inhibitor resistant locally advanced (inoperable) or metastatic breast cancer |
|
(PP) |
|
Launched |
|
volrustomig eVOLVE-Cervical |
|
PD-1/CTLA-4 bispecific mAb |
|
locally advanced cervical cancer |
|
|
|
>2025 |
|
volrustomig eVOLVE-HNSCC |
|
PD-1/CTLA-4 bispecific mAb |
|
unresected locally advanced head and neck squamous cell carcinoma |
|
|
|
>2025 |
|
volrustomig eVOLVE-Lung02 |
|
PD-1/CTLA-4 bispecific mAb |
|
1L metastatic NSCLC |
|
|
|
>2025 |
|
volrustomig eVOLVE-Meso |
|
PD-1/CTLA-4 bispecific mAb |
|
1L unresectable malignant pleural mesothelioma |
|
|
|
>2025 |
|
CVRM |
|
|
|
|
|
|
|
|
|
Andexxa |
|
anti-factor Xa reversal |
|
acute major bleed |
|
|
|
Launched |
|
baxdrostat |
|
aldosterone synthase inhibitor |
|
hypertension |
|
|
|
>2025 |
|
roxadustat OLYMPUS ROCKIES |
|
hypoxia-inducible factor prolyl hydroxylase inhibitor |
|
anaemia in chronic kidney disease/end-stage renal disease |
|
(PP) |
|
Launched |
|
Wainua (eplontersen) |
|
ligand-conjugated antisense |
|
patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) |
|
(PP) |
|
Launched |
|
zibotentan/dapagliflozin |
|
endothelin A receptor antagonist/SGLT2 inhibitor |
|
CKD with high proteinuria |
|
|
|
>2025 |
|
Respiratory & Immunology |
|
|
|
|
|
|
|
|
|
Fasenra CALIMA SIROCCO ZONDA MIRACLE |
|
IL-5R mAb |
|
severe uncontrolled asthma |
|
(PP) |
|
Launched |
|
Saphnelo TULIP 1 & TULIP 2 AZALEA (China) |
|
type I IFN receptor mAb |
|
systemic lupus erythematosus |
|
(PP) |
|
Launched |
|
Tezspire NAVIGATOR DIRECTION (China) |
|
TSLP mAb |
|
severe uncontrolled asthma |
|
(PP) |
|
Launched |
|
tozorakimab OBERON TITANIA PROSPERO MIRANDA |
|
IL-33 mAb |
|
chronic obstructive pulmonary disease |
|
|
|
>2025 |
|
tozorakimab TILIA |
|
IL-33 mAb |
|
severe viral lower respiratory tract disease |
|
|
|
2025 |
|
Vaccine and Immune Therapies |
|
|
|
|
|
|
|
|
|
Beyfortus |
|
RSV mAb-YTE |
|
passive RSV immunisation |
|
(PP) |
|
Launched |
|
sipavibart (AZD3152) SUPERNOVA |
|
SARS-CoV-2 LAAB |
|
prevention of COVID-19 |
|
|
|
H1 2024 |
|
Rare Disease |
|
|
|
|
|
|
|
|
|
acoramidis |
|
oral TTR stabiliser |
|
transthyretin amyloid cardiomyopathy |
|
(PP) |
|
H1 2024 |
|
ALXN2220 |
|
transthyretin depleter |
|
transthyretin amyloid cardiomyopathy |
|
(PP) |
|
>2025 |
|
anselamimab |
|
fibril-reactive mAb |
|
amyloid light chain amyloidosis |
|
|
|
2025 |
|
efzimfotase alfa (ALXN1850) |
|
next generation TNSALP ERT |
|
hypophosphatasia |
|
|
|
>2025 |
|
gefurulimab |
|
humanised bispecific VHH antibody |
|
generalised myasthenia gravis |
|
|
|
>2025 |
|
Voydeya (danicopan) ALPHA |
|
oral factor D inhibitor |
|
paroxysmal nocturnal haemoglobinuria with clinically significant extravascular haemolysis |
|
|
|
Approved |
|
17
Significant Life-cycle Management
First major market regulatory submission date and submission status is provided for assets in Phase III or beyond. Projects in Phase III unless otherwise noted.
Compound |
|
Mechanism |
|
Area Under Investigation |
|
Additional |
|
Estimated |
|
|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
|
|
|
Oncology |
|
|
|
|
|
|
|
|
|
Calquence + R-CHOP ESCALADE |
|
BTK inhibitor + R-CHOP |
|
1st-line diffuse large B cell lymphoma |
|
|
|
>2025 |
|
Calquence + venetoclax + obinutuzumab AMPLIFY |
|
BTK inhibitor + BCL-2 inhibitor + anti-CD20 mAb |
|
1st-line chronic lymphocytic leukaemia |
|
(PP) |
|
>2025 |
|
Calquence ECHO |
|
BTK inhibitor |
|
1st-line mantle cell lymphoma |
|
(PP) |
|
>2025 |
|
Calquence ELEVATE-TN ChangE (China) |
|
BTK inhibitor |
|
1st-line chronic lymphocytic leukaemia |
|
(PP) |
|
Launched |
|
Enhertu (platform) DESTINY-Breast07 |
|
HER2 targeting antibody drug conjugate |
|
HER2+ breast cancer |
|
(PP) Phase II LCM |
|
|
|
Enhertu (platform) DESTINY-Breast08 |
|
HER2 targeting ADC |
|
HER2-low breast cancer |
|
(PP) Phase I LCM |
|
|
|
Enhertu DESTINY-Breast02 |
|
HER2 targeting ADC |
|
HER2+, unresectable and/or metastatic breast cancer pretreated with prior standard of care HER2 therapies, including T-DM1 |
|
(PP) |
|
Approved |
|
Enhertu DESTINY-Breast05 |
|
HER2 targeting ADC |
|
HER2+ post-neoadjuvant high-risk breast cancer |
|
(PP) |
|
>2025 |
|
Enhertu DESTINY-Breast06 |
|
HER2 targeting ADC |
|
post-ET HER2-low/HR+ breast cancer 2L |
|
(PP) |
|
H2 2024 |
|
Enhertu DESTINY-Breast09 |
|
HER2 targeting ADC |
|
1st-line HER2+ breast cancer |
|
(PP) |
|
2025 |
|
Enhertu DESTINY-Breast11 |
|
HER2 targeting ADC |
|
neoadjuvant HER2+ breast cancer |
|
(PP) |
|
2025 |
|
Enhertu DESTINY-Gastric01 |
|
HER2 targeting ADC |
|
HER2-over-expressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens |
|
(PP) |
|
Launched |
|
Enhertu DESTINY-Gastric04 |
|
HER2 targeting ADC |
|
2nd-line HER2+ gastric cancer |
|
(PP) |
|
>2025 |
|
Enhertu DESTINY-Lung04 |
|
HER2 targeting ADC |
|
1st-line HER2m NSCLC |
|
(PP) |
|
>2025 |
|
Enhertu DESTINYPanTumour01 |
|
HER2 targeting ADC |
|
HER2 mutant tumours |
|
(PP) Phase II LCM |
|
|
|
Enhertu DESTINYPanTumour02 |
|
HER2 targeting ADC |
|
HER2 expressing solid tumours |
|
(PP) Phase II LCM |
|
Accepted |
|
Imfinzi (platform) BEGONIA |
|
PD-L1 mAb with paclitaxel and multiple novel oncology therapies |
|
1st-line metastatic triple negative breast cancer |
|
Phase II LCM |
|
|
|
Imfinzi (platform) HUDSON |
|
PD-L1 mAb + multiple novel oncology therapies |
|
post IO NSCLC |
|
Phase II LCM |
|
|
|
Imfinzi + CRT KUNLUN |
|
PD-L1 mAb + CRT |
|
locally advanced oesophageal squamous cell carcinoma |
|
(PP) |
|
>2025 |
|
Imfinzi + CRT PACIFIC-5 (China) |
|
PD-L1 mAb + CRT |
|
locally-advanced (Stage III) NSCLC |
|
(PP) |
|
2025 |
|
Imfinzi + CTx neoadjuvant AEGEAN |
|
PD-L1 mAb + CTx |
|
locally-advanced (Stage II-III) NSCLC |
|
|
|
Accepted |
|
Imfinzi + CTx NIAGARA |
|
PD-L1 mAb + CTx |
|
muscle invasive bladder cancer |
|
|
|
2025 |
|
Imfinzi + domvanalimab (AB154) PACIFIC-8 |
|
PD-L1 mAb + TIGIT |
|
unresectable Stage III NSCLC |
|
(PP) |
|
>2025 |
|
Imfinzi + EV +/- Imjudo VOLGA |
|
PD-L1 + nectin-4 targeting ADC +/- CTLA-4 |
|
muscle invasive bladder cancer |
|
|
|
2025 |
|
Imfinzi + FLOT MATTERHORN |
|
PD-L1 mAb + CTx |
|
neoadjuvant/adjuvant gastric cancer |
|
(PP) |
|
2025 |
|
Imfinzi + Imjudo +SoC NILE |
|
PL-L1 mAb + CTLA-4 mAb + SoC |
|
1st-line urothelial cancer |
|
|
|
H2 2024 |
|
Imfinzi + Imjudo + TACE +/- lenvatinib EMERALD-3 |
|
PD-L1 + CTLA-4 + VEGF +/- chemoembolisation |
|
locoregional hepatocellular carcinoma |
|
|
|
>2025 |
|
Imfinzi + VEGF + TACE EMERALD-1 |
|
PD-L1 mAb + VEGF + TACE |
|
locoregional hepatocellular carcinoma |
|
(PP) |
|
H1 2024 |
|
Imfinzi + VEGF EMERALD-2 |
|
PD-L1 mAb + VEGF |
|
adjuvant hepatocellular carcinoma |
|
(PP) |
|
2025 |
|
mfinzi +/- Imjudo + CRT ADRIATIC |
|
PD-L1 mAb +/- CTLA-4 mAb + CRT |
|
1st-line limited-stage small-cell lung cancer |
|
(PP) |
|
H2 2024 |
|
Imfinzi +/- Imjudo + CTx POSEIDON |
|
PD-L1 mAb +/- CTLA-4 mAb + CTx |
|
1st-line NSCLC |
|
|
|
Launched |
|
Imfinzi (platform) NeoCOAST-2 |
|
PD-L1 mAb + multiple novel oncology therapies |
|
NSCLC |
|
(PP) Phase II LCM |
|
|
|
Imfinzi post-SBRT PACIFIC-4 |
|
PD-L1 mAb post-SBRT |
|
Stage I/II NSCLC |
|
PP |
|
>2025 |
|
Imfinzi POTOMAC |
|
PD-L1 mAb |
|
non-muscle invasive bladder cancer |
|
|
|
2025 |
|
Lynparza (basket) LYNK002 |
|
PARP inhibitor |
|
HRRm cancer |
|
(PP) Phase II LCM |
|
|
|
Lynparza +abiraterone PROpel |
|
PARP inhibitor + NHA |
|
prostate cancer |
|
(PP) |
|
Launched |
|
Lynparza + Imfinzi + bevacizumab DUO-O |
|
PARP inhibitor + PD-L1 mAb + VEGF inhibitor |
|
1st-line ovarian cancer |
|
( PP) |
|
H1 2024 |
|
Lynparza + Imfinzi DUO-E |
|
PARP inhibitor + PD-L1 mAb |
|
1st-line endometrial cancer |
|
(PP) |
|
Submitted |
|
Lynparza MONO-OLA1 |
|
PARP inhibitor |
|
1st-line BRCAwt ovarian cancer |
|
(PP) |
|
2025 |
|
Lynparza OlympiA |
|
PARP inhibitor |
|
gBRCA adjuvant breast cancer |
|
(PP) |
|
Launched |
|
Orpathys + Imfinzi SAMETA |
|
MET inhibitor + PD-L1 mAb |
|
1st-line papillary renal cell carcinoma |
|
(PP) |
|
2025 |
|
Tagrisso + CTx FLAURA2 |
|
EGFR inhibitor + CTx |
|
1st-line advanced EGFRm NSCLC |
|
|
|
Accepted |
|
Tagrisso + Orpathys SAFFRON |
|
EGFR inhibitor + MET inhibitor |
|
advanced EGFRm NSCLC |
|
(PP) |
|
2025 |
|
18
Compound |
|
Mechanism |
|
Area Under Investigation |
|
Additional |
|
Estimated |
|
|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
|
|
|
Tagrisso + Orpathys SAVANNAH |
|
EGFR inhibitor + MET inhibitor |
|
advanced EGFRm NSCLC |
|
(PP) Phase II LCM |
|
|
|
Tagrisso +/- CTx neoadjuvant NeoADAURA |
|
EGFR inhibitor +/- CTx |
|
Stage II/III resectable EGFRm NSCLC |
|
|
|
H2 2024 |
|
Tagrisso ADAURA2 |
|
EGFR inhibitor |
|
adjuvant EGFRm NSCLC Stage Ia2-Ia3 following complete tumour resection |
|
|
|
>2025 |
|
Tagrisso LAURA |
|
EGFR inhibitor |
|
Stage III EGFRm non-small cell lung cancer |
|
|
|
H1 2024 |
|
Tagrisso ORCHARD platform study |
|
EGFR inhibitor + multiple novel oncology therapies |
|
2nd-line EGFRm osimertinib-resistant NSCLC |
|
(PP) Phase II LCM |
|
|
|
Truqap (capivasertib) |
|
AKT inhibitor |
|
prostate cancer |
|
Phase II LCM |
|
|
|
Truqap (capivasertib) + abiraterone CAPItello-281 |
|
AKT inhibitor + abiraterone |
|
PTEN deficient metastatic hormone sensitive prostate cancer |
|
|
|
2025 |
|
Truqap (capivasertib) + CTx CAPItello-290 |
|
AKT inhibitor + CTx |
|
1st-line metastatic triple negative breast cancer |
|
|
|
H2 2024 |
|
Truqap (capivasertib) + docetaxel CAPItello-280 |
|
AKT inhibitor + docetaxel |
|
mCRPC prostate cancer |
|
|
|
>2025 |
|
Truqap (capivasertib) + Faslodex + Palbociclib CAPItello-292 |
|
AKT inhibitor + fulvestrant + CDK4/6 inhibitor |
|
1st-line triplet in early relapse/ET resistant locally advanced (inoperable) or metastatic breast cancer |
|
PhIb/III |
|
>2025 |
|
CVRM |
|
|
|
|
|
|
|
|
|
Andexxa |
|
anti-factor Xa reversal |
|
urgent surgery |
|
|
|
|
|
Farxiga/Forxiga DAPA-MI |
|
SGLT-2 inhibitor |
|
prevention of heart failure and CV death following a myocardial infarction |
|
|
|
n/a |
|
Roxadustat |
|
hypoxia-inducible factor prolyl hydroxylase inhibitor |
|
chemotherapy induced anaemia |
|
(PP) |
|
Accepted |
|
Wainua (eplontersen) |
|
ligand-conjugated antisense |
|
patients with hereditary or wild-type transthyretin-mediated amyloid cardiomyopathy (ATTR CM) |
|
(PP) |
|
2025 |
|
Respiratory & Immunology |
|
|
|
|
|
|
|
|
|
Breztri/Trixeo (PT010) KALOS LOGOS |
|
LABA/LAMA/ICS |
|
asthma |
|
|
|
2025 |
|
Breztri/Trixeo ATHLOS |
|
LABA/LAMA/ICS |
|
COPD cardiopulmonary exercise test (CPET) trial |
|
|
|
2025 |
|
Fasenra MANDARA |
|
IL-5R mAb |
|
eosinophilic granulomatosis with polyangiitis |
|
|
|
Submitted |
|
Fasenra NATRON |
|
IL-5R mAb |
|
hypereosinophilic syndrome |
|
|
|
H2 2024 |
|
Fasenra ORCHID |
|
IL-5R mAb |
|
nasal polyps |
|
(PP) |
|
2025 |
|
Fasenra RESOLUTE |
|
IL-5R mAb |
|
chronic obstructive pulmonary disease |
|
(PP) |
|
>2025 |
|
Saphnelo DAISY |
|
type I IFN receptor mAb |
|
systemic sclerosis |
|
(PP) |
|
>2025 |
|
Saphnelo IRIS |
|
type I IFN receptor mAb |
|
lupus nephritis |
|
(PP) |
|
>2025 |
|
Saphnelo TULIP-SC |
|
type I IFN receptor mAb |
|
systemic lupus erythematosus (subcutaneous) |
|
(PP) |
|
2025 |
|
Tezspire COURSE |
|
TSLP mAb |
|
chronic obstructive pulmonary disease |
|
(PP) Phase II LCM |
|
|
|
Tezspire CROSSING |
|
TSLP mAb |
|
eosinophilic esophagitis |
|
(PP) |
|
>2025 |
|
Tezspire WAYPOINT |
|
TSLP mAb |
|
nasal polyps |
|
(PP) |
|
2025 |
|
Rare Disease |
|
|
|
|
|
|
|
|
|
Ultomiris |
|
anti-complement C5 mAb |
|
proliferative lupus nephritis or immunoglobulin A nephropathy |
|
Phase II LCM |
|
|
|
Ultomiris |
|
anti-complement C5 mAb |
|
haematopoietic stem cell transplant–associated thrombotic microangiopathy |
|
|
|
2025 |
|
Ultomiris |
|
anti-complement C5 mAb |
|
generalised myasthenia gravis |
|
|
|
Launched |
|
Ultomiris ARTEMIS |
|
anti-complement C5 mAb |
|
cardiac surgery-associated acute kidney injury |
|
|
|
>2025 |
|
Ultomiris CHAMPIONN-MOSD |
|
anti-complement C5 mAb |
|
neuromyelitis optica spectrum disorder |
|
|
|
Launched |
|
19
Patent Expiries of Key Marketed Products
Patents covering our products are, or may be, challenged by third parties. Generic products may be launched ‘at risk’ and our patents may be revoked, circumvented or found not to be infringed. Details of material challenges by third parties can be found in “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024, and incorporated by reference. The expiry dates shown below include granted Supplementary Protection Certificate (SPC) and Patent Term Extension (PTE) and/or Paediatric Exclusivity periods (as appropriate). In Europe, the exact SPC situation may vary by country as different Patent Offices grant SPCs at different rates. The expiry dates of relevant regulatory data exclusivity periods are not represented in the table below. A number of our products are subject to generic competition in one or more markets. There may be agreements permitting generic or biosimilar entry prior to the expiry dates shown below. Bolded expiry dates relate to new molecular entity patents, the remaining dates relate to other patents.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate Product |
||||
|
|
|
|
|
|
|
|
|
|
|
|
US |
|
Sales Ex-US |
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Product Sales ($m) |
|
($m) |
||||||||
Key Marketed products |
|
Description |
|
US |
|
China |
|
EU |
|
Japan |
|
2023 |
|
2022 |
|
2021 |
|
2023 |
|
2022 |
|
2021 |
Oncology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Calquence (acalabrutinib) |
|
A selective inhibitor of Bruton’s tyrosine kinase indicated for the treatment of chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL) and in development for the treatment of multiple B-cell malignancies. |
|
2026–2032, 2032–2036 |
|
2032, 2036 |
|
2032-2035, 2036 |
2 |
2037, 2036 |
|
1,815 |
|
1,657 |
|
1,089 |
|
699 |
|
400 |
|
149 |
Enhertu3 (trastuzumab deruxtecan) |
|
A HER2-directed antibody drug conjugate indicated for HER2-positive and HER2-low advanced breast cancers, for HER2-mutant metastatic non-small cell lung cancer (NSCLC), and for HER2-positive advanced gastric cancer. |
|
2033, 2035 |
|
2033-2035 |
|
2033-2035 |
|
|
4 |
— |
|
— |
|
— |
|
261 |
|
79 |
|
17 |
Faslodex (fulvestrant) |
|
An injectable oestrogen receptor antagonist used for the treatment of hormone receptor positive advanced breast cancer that has progressed following treatment with prior endocrine therapy. |
|
expired |
|
expired |
|
expired |
|
2025-2026 |
|
31 |
|
17 |
|
30 |
|
266 |
|
317 |
|
401 |
Imfinzi (durvalumab) |
|
A human monoclonal antibody (mAb) that blocks PD-1 and CD80 on T-cells indicated for unresectable, Stage III NSCLC, for extensive-stage small cell lung cancer in combination with chemotherapy, for advanced biliary tract cancer in combination with chemotherapy, for unresectable heptatocellular carcinoma (uHCC) in combination with Imjudo, for NSCLC in combination with Imjudo and chemotherapy, and for advanced bladder cancer. |
|
2031 |
|
2030 |
|
2030 |
|
2033 |
|
2,171 |
|
1,539 |
|
1,245 |
|
1,848 |
|
1,232 |
|
1,167 |
Imjudo5 (tremelimumab) |
|
A cytotoxic T-lymphocyte-associated antigen 4 blocking antibody indicated for uHCC in combination with Imfinzi and for NSCLC in combination with Imfinzi and chemotherapy. |
|
2031 |
|
2026 |
|
2026 |
|
2026 |
|
146 |
|
13 |
|
— |
|
72 |
|
— |
|
— |
Iressa (gefitinib) |
|
An epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that acts to block signals for cancer cell growth and survival in advanced NSCLC. |
|
expired |
|
2023 |
|
2023 |
|
2023 |
|
5 |
|
9 |
|
11 |
|
66 |
|
105 |
|
172 |
Lynparza6 (olaparib) |
|
An oral poly ADP-ribose polymerase (PARP) inhibitor indicated for platinum-sensitive relapsed and for BRCA-mutated (BRCAm) ovarian cancers, for homologous recombination repair deficient (HRD)-positive advanced ovarian cancer in combination with bevacizumab, for gBRCAm, HER2-negative early and metastatic breast cancers, for gBRCAm metastatic pancreatic cancer, for HRR gene-mutated and BRCAm metastatic castration-resistant prostate cancers (mCRPC), and for 1st-line mCRPC in combination with abiraterone. |
|
2022-2024, 2027*, 2024-2031 |
|
2024, 2024-2029 |
|
2029, 2024-2029 |
|
2029, 2024-2034 |
|
1,254 |
|
1,226 |
|
1,087 |
|
1,557 |
|
1,412 |
|
1,261 |
Orpathys (savolitinib) |
|
An oral, potent and highly selective MET TKI indicated for NSCLC with MET gene alterations. |
|
2030 |
|
2030 |
|
2030 |
|
2030 |
|
— |
|
— |
|
— |
|
44 |
|
33 |
|
16 |
Tagrisso (osimertinib) |
|
An EGFR-TKI indicated for early- and late-stage EGFRm NSCLC. |
|
2032, 2035 |
|
2032, 2035 |
|
2032, 2035 |
|
2034, 2035 |
|
2,276 |
|
2,007 |
|
1,780 |
|
3,523 |
|
3,437 |
|
3,235 |
Truqap (capivasertib) |
|
A first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor approved in combination with Faslodex for HR-positive, HER2-negative advanced breast cancer with certain gene alterations. |
|
2028-2030, 2025-2033 |
|
2028, 2033 |
|
2028, 2025-2033 |
|
2028 |
|
6 |
|
— |
|
— |
|
— |
|
— |
|
— |
Zoladex7 (goserelin acetate implant) |
|
A luteinising hormone-releasing hormone (LHRH) agonist used to treat prostate cancer, breast cancer and certain benign gynaecological disorders. |
|
expired |
|
expired |
|
expired |
|
expired |
|
14 |
|
15 |
|
13 |
|
938 |
|
912 |
|
935 |
CVRM |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Andexxa/ Ondexxya (andexanet alfa) |
|
A factor Xa inhibitor reversal agent. |
|
2032, 2028–2037 |
|
2028, 2030–2035 |
|
2028, 2030–2037 |
|
2028, 2030–2037 |
|
75 |
|
77 |
|
50 |
|
107 |
|
73 |
|
18 |
Brilinta/ Brilique (ticagrelor) |
|
An oral P2Y12 platelet inhibitor for acute coronary syndromes (ACS) (ticagrelor 90mg) or continuation therapy in high-risk patients (ticagrelor 60mg) with a history of myocardial infarction (MI). An oral P2Y12 platelet inhibitor for the prevention of atherothrombotic events in adult patients with ACS or high-risk patients with history of MI, high-risk patients with coronary artery disease or stroke. |
|
2025, 2030-2036 |
|
expired |
|
2025 |
|
2023-2024, 2025-2030 |
|
744 |
|
744 |
|
735 |
|
580 |
|
614 |
|
737 |
Bydureon/ Bydureon BCise (exenatide XR injectable suspension) |
|
An injectable glucagon-like Peptide-1 receptor agonist (GLP-1RA) available as a single-dose tray, a single-dose pen or autoinjector device indicated for use in adults with type-2 diabetes (T2D). |
|
2024-2028, 2031 |
8 |
2024-2028, 2029 |
8 |
2024-2028, 2029 |
8 |
2024-2028, 2029 |
8 |
133 |
|
242 |
|
321 |
|
30 |
|
38 |
|
64 |
Byetta (exenatide injection) |
|
An injectable GLP-1RA indicated for adults with T2D. |
|
expired |
|
expired |
|
expired |
|
expired |
|
8 |
|
14 |
|
26 |
|
11 |
|
17 |
|
30 |
20
Key Marketed products |
|
Description |
|
US |
|
China |
|
EU |
|
Japan |
|
2023 |
|
2022 |
|
2021 |
|
2023 |
|
2022 |
|
2021 |
Crestor (rosuvastatin calcium) |
|
A statin for dyslipidaemia and hypercholesterolaemia. |
|
expired |
|
expired |
|
expired |
|
2023 |
|
55 |
|
65 |
|
80 |
|
1,052 |
|
983 |
|
1,016 |
Farxiga/ Forxiga (dapagliflozin) |
|
A sodium-glucose cotransporter 2 (SGLT-2 inhibitor) indicated for adult patients with T2D or in adults with or without T2D with heart failure with reduced ejection fraction or chronic kidney disease (CKD). |
|
2025, 2025-2040 |
|
2023, 2028-2041 |
|
2027 |
|
2024-2025, 2028 |
|
1,339 |
|
960 |
|
644 |
|
3,795 |
|
2,711 |
|
1,770 |
Komboglyze/ Kombiglyze XR9 (saxagliptin/ metformin) |
|
Combines saxagliptin and metformin as either Komboglyze, for T2D, or Kombiglyze XR, an extended release tablet for T2D. |
|
2023, 2025 |
|
2025 |
|
2026, 2025 |
|
|
4 |
17 |
|
25 |
|
32 |
|
94 |
|
88 |
|
92 |
Lokelma (sodium zirconium cyclosilicate) |
|
An insoluble, non-absorbed sodium zirconium cyclosilicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing agent for the treatment of hyperkalaemia. |
|
2032-2035 |
|
203310 -2034 |
|
2032 |
2 |
2032-2037 |
|
214 |
|
170 |
|
115 |
|
198 |
|
119 |
|
60 |
Onglyza (saxagliptin) |
|
An oral dipeptidyl peptidase 4 inhibitor for T2D. |
|
2023, 2028 |
|
2025 |
|
2024, 2025 |
|
|
4 |
32 |
|
51 |
|
56 |
|
84 |
|
93 |
|
179 |
Roxadustat11 |
|
An oral hypoxia-inducible factor prolyl hydroxylase inhibitor indicated for the treatment of anaemia from CKD. |
|
2024, 2024-2034 |
|
2024, 2024-2033 |
|
|
4 |
|
4 |
— |
|
— |
|
— |
|
271 |
|
197 |
|
174 |
Wainua (eplontersen) |
|
Wainua injection, for subcutaneous use, is a prescription medicine used to treat adults with polyneuropathy of hereditary transthyretinmediated amyloidosis. |
|
2034 |
|
2034 |
|
2034 |
|
2034 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Xigduo/ Xigduo XR12 (dapagliflozin/ metformin) |
|
Combines dapagliflozin and metformin as either Xigduo – to improve glycaemic control in adults with T2D who are inadequately controlled on metformin alone, or Xigduo XR – an extended release tablet for adults with T2D who are inadequately controlled on metformin alone. |
|
2025, 2025-2030 |
|
2023 |
|
2028 |
|
2024-2025, 2030 |
|
112 |
|
111 |
|
88 |
|
717 |
|
599 |
|
498 |
Respiratory & Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Airsupra (albuterol/budesonide) |
|
A first-in-class, fixed-dose combination rescue medication for asthma in the US containing a short-acting beta2-agonist (SABA) and an anti-inflammatory inhaled corticosteroid (ICS), for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations, developed in a pressurized metered-dose inhaler (pMDI) using AstraZeneca’s Aerosphere delivery technology. |
|
2030 |
|
2030 |
|
|
|
2030 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Bevespi Aerosphere (glycopyrrolate/formoterol) |
|
A combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) delivered in a pressurised metered-dose inhaler (pMDI) used for the long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). |
|
2030-2031 |
|
2030 |
|
2030 |
|
2030-2034 |
|
34 |
|
42 |
|
39 |
|
24 |
|
16 |
|
15 |
Breztri/Trixeo Aerosphere (PT010) (budesonide/ glycopyrrolate/ formoterol) |
|
A fixed-dose triple combination of an inhaled corticosteroid (ICS), a LAMA and a LABA delivered in a pMDI, used for the long-term maintenance treatment of COPD. |
|
2030-2031, 2038 |
|
2030, 2038 |
|
2030, 2038 |
|
2030-2034, 2038 |
|
383 |
|
239 |
|
115 |
|
294 |
|
159 |
|
88 |
Daliresp/ Daxas (roflumilast) |
|
An oral phosphodiesterase-4 inhibitor for adults with severe COPD to decrease their number of exacerbations. |
|
2023-2024 |
|
2023 |
|
2023 |
|
expired |
|
42 |
|
176 |
|
207 |
|
12 |
|
13 |
|
20 |
Fasenra (benralizumab) |
|
A mAb which directly targets and depletes eosinophils by recruiting natural killer cells and inducing apoptosis (programmed cell death). Approved as an add-on maintenance treatment for severe eosinophilic asthma. |
|
2024, 2028-2034 |
|
2028 |
|
2025, 2028-2034 |
|
2025, 2034 |
|
992 |
|
906 |
|
790 |
|
561 |
|
490 |
|
468 |
Pulmicort (budesonide) |
|
An ICS for maintenance treatment of asthma available as Turbuhaler and as Respules. |
|
expired |
|
expired |
|
expired |
|
expired |
|
28 |
|
65 |
|
72 |
|
685 |
|
580 |
|
890 |
Saphnelo (anifrolumab) |
|
A first-in-class fully human mAb for moderate to severe systemic lupus erythematosus (SLE) that binds to subunit 1 of the type I IFN receptor, blocking the activity of type I IFNs. Type I IFNs such as IFN-alpha, IFN-beta and IFN-kappa are cytokines involved in driving the inflammatory pathways implicated in SLE. |
|
2025-2029, 2033-2036 |
|
2025-2029 |
|
2025-2029, 2036 |
|
2030-2034, 2033-2036 |
|
260 |
|
111 |
|
8 |
|
20 |
|
5 |
|
– |
Symbicort (budesonide/ formoterol) |
|
A combination of an inhaled corticosteroid and a fast-onset LABA to treat asthma and/or COPD either as Symbicort Turbuhaler or Symbicort pMDI. |
|
2023- 2029 |
13 |
expired |
|
expired |
|
expired |
|
726 |
|
973 |
|
1,065 |
|
1,636 |
|
1,565 |
|
1,663 |
Tezspire14 (tezepelumab) |
|
A first-in-class human mAb that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of airway inflammation and airway hyperresponsiveness in severe asthma. Approved for a broad population of severe asthma patients, without phenotype and biomarker limitation. Developed in collaboration with Amgen. |
|
2028, 2038 |
|
2028 |
|
2028 |
|
2028, 2038 |
|
— |
|
— |
|
— |
|
86 |
|
4 |
|
– |
Vaccines & Immune Therapies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beyfortus (nirsevimab) |
|
A long-acting anti-RSV F mAb used to prevent RSV lower respiratory tract disease in neonates and infants during their first RSV season. Jointly developed and commercialised with Sanofi. |
|
2028–2035, 2038 |
|
|
|
2035 |
|
2035, 2038 |
|
87 |
|
— |
|
— |
|
19 |
|
— |
|
— |
Evusheld (tixagevimab co-packaged with cilgavimab) |
|
A combination of two long-acting antibodies, developed for the prevention and treatment of COVID-19. |
|
2041 |
|
|
|
|
|
|
|
– |
|
1,067 |
|
– |
|
132 |
|
1,118 |
|
85 |
Fluenz Tetra/ FluMist Quadrivalent (live attenuated influenza vaccine) |
|
A live attenuated vaccine indicated for active immunisation for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. |
|
2025-2026 |
|
2025 |
|
2025 |
|
2025 |
15 |
23 |
|
21 |
|
27 |
|
193 |
|
154 |
|
226 |
Synagis (palivizumab) |
|
A humanised mAb used to prevent serious lower respiratory tract disease caused by RSV in infants at high risk of acquiring RSV disease. |
|
2023 |
16 |
expired |
|
2023 |
|
2023 |
|
(1) |
|
1 |
|
23 |
|
547 |
|
577 |
|
387 |
Vaxzevria17 (ChAdOx1-S Recombinant) |
|
An adenoviral vector vaccine, based on a weakened version of the common cold virus, for active immunisation against COVID-19. |
|
2032 |
|
2032 |
|
2032 |
|
2032 |
|
— |
|
79 |
|
64 |
|
12 |
|
1,719 |
|
3,853 |
21
Key Marketed products |
|
Description |
|
US |
|
China |
|
EU |
|
Japan |
|
2023 |
|
2022 |
|
2021 |
|
2023 |
|
2022 |
|
2021 |
Rare Disease |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kanuma (sebelipase alfa) |
|
A recombinant form of the human lysosomal acid lipase (LAL) enzyme, the enzyme replacement therapy is for the treatment of LAL deficiency. |
|
2031 |
|
2031 |
|
2031, 2026-2037 |
|
2031, 2032 |
|
85 |
|
77 |
|
32 |
|
86 |
|
83 |
|
30 |
Koselugo (selumetinib) |
|
A specific enzymes-inhibitor which blocks mitogen-activated protein kinases (MEK1 and MEK2), which are involved in stimulating cells to grow. In neurofibromatosis type 1, these enzymes are overactive, causing tumour cells to grow in an unregulated way. By blocking these enzymes, Koselugo slows down the growth of tumour cells. |
|
2023, 2023-2029 |
|
2023, 2026-2029 |
|
2023, 2026-2029 |
|
2023, 2023-2029 |
|
195 |
|
162 |
|
104 |
|
136 |
|
46 |
|
4 |
Soliris (eculizumab) |
|
A C5 inhibitor for the treatment of paroxysmal nocturnal haemoglobinuria, atypical haemolytic uraemic syndrome, generalised myasthenia gravis and neuromyelitis optica spectrum disorder. |
|
2027, 2025-2032 |
18 |
2029 |
|
2029 |
19 |
2027, 2029 |
|
1,734 |
|
2,180 |
|
1,068 |
|
1,411 |
|
1,582 |
|
806 |
Strensiq (asfotase alfa) |
|
A targeted enzyme replacement therapy for patients with hypophosphatasia. |
|
2025-2029, 2035-2038 |
|
|
|
2025-2031, 2036 |
|
2028, 2035-2036 |
|
937 |
|
769 |
|
297 |
|
215 |
|
189 |
|
81 |
Ultomiris (ravulizumab) |
|
A long-acting C5 inhibitor for the treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome, generalised myasthenia gravis and neuromyelitis optica spectrum disorder. |
|
2035, 2038 |
|
2035, 2038 |
|
2035, 2038-2039 |
|
2037, 2038 |
|
1,750 |
|
1,136 |
|
381 |
|
1,251 |
|
829 |
|
307 |
Voydeya (danicopan) |
|
An oral, Factor D inhibitor developed as add-on to proven standard-of-care Ultomiris or Soliris to address the needs of the subset of patients with PNH who experience clinically significant extravascular haemolysis while treated with a C5 inhibitor. |
|
2035 |
|
2035 |
|
2035 |
|
2035 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium20 (esomeprazole) |
|
A proton pump inhibitor used to treat acid-related diseases. |
|
expired |
|
expired |
|
expired |
|
expired |
|
115 |
|
120 |
|
128 |
|
830 |
|
1,165 |
|
1,198 |
* |
Date represents expiry of a pending SPC/PTE and/or Paediatric Exclusivity period. |
1 |
Expiry in major EU markets, which includes the UK. |
2 |
The patent is the subject of a pending opposition proceeding at the European Patent Office (EPO). The patentee successfully defended the patent in that proceeding, but the opponents have appealed. |
3 |
AstraZeneca has recorded $1,022 million of Alliance Revenue in relation to this product in 2023 (2022: $523 million; 2021: $197 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
4 |
AstraZeneca does not have commercialisation rights. |
5 |
Imjudo Product Sales are included in the Imfinzi Product Sales figure. |
6 |
In addition to any Product Sales, AstraZeneca has also recorded $245 million of Collaboration Revenue in relation to this product in 2023 (2022: $355 million; 2021: $400 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
7 |
Rights licensed to TerSera Therapeutics LLC in the US. |
8 |
Patent expiry date relates to BCise. |
9 |
Komboglyze/Kombiglyze XR revenue is included in the Onglyza Product Sales figure. |
10 |
The patent is the subject of a pending invalidation proceeding at China National Intellectual Property Administration. |
11 |
AstraZeneca has recorded $5 million of Collaboration Revenue in relation to this product in 2023 (2022: $5 million; 2021: $6 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
12 |
Xigduo/Xigduo XR Product Sales are included in the Farxiga Product Sales figure. |
13 |
Patent expiry information relates to the Symbicort pMDI product, including any granted Paediatric Exclusivity term. |
14 |
AstraZeneca has recorded $259 million of Alliance Revenue in relation to this product in 2023 (2022: $79 million; 2021: $nil), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
15 |
Rights licensed to Daiichi Sankyo, Inc. |
16 |
Rights sold to Sobi. |
17 |
AstraZeneca has recorded $nil of Alliance Revenue in relation to this product in 2023 (2022: $76 million; 2021: $64 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
18 |
Settled with Amgen for licensed biosimilar entry date of 1 March 2025. The patents expiring in 2027 are the subject of pending inter partes review proceedings before the United States Patent Office. |
19 |
The patent is the subject of a pending opposition proceeding at the EPO. Alexion has consented to revocation of this patent in the UK and has withdrawn this patent in the Netherlands. |
20 |
AstraZeneca has recorded $nil of Collaboration Revenue in relation to this product in 2023 (2022: $62 million; 2021: $75 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
22
Geographical Review
This section Item 4—“Information on the Company— Business Overview—Geographical Review” should be read in conjunction with Item 5—“Operating and Financial Review and Prospects—Operating Results” below.
|
|
World |
|
US |
|
Emerging Markets |
|
Europe |
|
Established ROW |
||||||||||||||||||
|
|
Sales |
|
Actual |
|
CER |
|
Sales |
|
Actual |
|
Sales |
|
Actual |
|
CER |
|
Sales |
|
Actual |
|
CER |
|
Sales |
|
Actual |
|
CER |
2023 |
|
$m |
|
% |
|
% |
|
$m |
|
% |
|
$m |
|
% |
|
% |
|
$m |
|
% |
|
% |
|
$m |
|
% |
|
% |
Oncology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso |
|
5,799 |
|
7 |
|
9 |
|
2,276 |
|
13 |
|
1,621 |
|
3 |
|
10 |
|
1,120 |
|
10 |
|
8 |
|
782 |
|
(8) |
|
(1) |
Imfinzi |
|
4,237 |
|
52 |
|
55 |
|
2,317 |
|
49 |
|
360 |
|
25 |
|
39 |
|
758 |
|
39 |
|
36 |
|
802 |
|
n/m |
|
n/m |
Lynparza |
|
2,811 |
|
7 |
|
9 |
|
1,254 |
|
2 |
|
542 |
|
11 |
|
21 |
|
734 |
|
12 |
|
10 |
|
281 |
|
5 |
|
12 |
Calquence |
|
2,514 |
|
22 |
|
23 |
|
1,815 |
|
10 |
|
98 |
|
n/m |
|
n/m |
|
493 |
|
72 |
|
69 |
|
108 |
|
58 |
|
65 |
Enhertu |
|
261 |
|
n/m |
|
n/m |
|
— |
|
— |
|
169 |
|
n/m |
|
n/m |
|
60 |
|
n/m |
|
n/m |
|
32 |
|
n/m |
|
n/m |
Orpathys |
|
44 |
|
34 |
|
42 |
|
— |
|
— |
|
44 |
|
34 |
|
42 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Truqap |
|
6 |
|
n/m |
|
n/m |
|
6 |
|
n/m |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Zoladex |
|
952 |
|
3 |
|
9 |
|
14 |
|
(4) |
|
687 |
|
5 |
|
12 |
|
133 |
|
— |
|
(1) |
|
118 |
|
(4) |
|
2 |
Faslodex |
|
297 |
|
(11) |
|
(6) |
|
31 |
|
87 |
|
142 |
|
(11) |
|
(6) |
|
28 |
|
(49) |
|
(50) |
|
96 |
|
(7) |
|
1 |
Others |
|
224 |
|
(33) |
|
(30) |
|
6 |
|
(44) |
|
165 |
|
(34) |
|
(31) |
|
6 |
|
(42) |
|
(41) |
|
47 |
|
(28) |
|
(23) |
Total Oncology |
|
17,145 |
|
17 |
|
20 |
|
7,719 |
|
19 |
|
3,828 |
|
8 |
|
16 |
|
3,332 |
|
22 |
|
20 |
|
2,266 |
|
20 |
|
29 |
BioPharmaceuticals: CVRM |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga |
|
5,963 |
|
36 |
|
39 |
|
1,451 |
|
35 |
|
2,211 |
|
33 |
|
40 |
|
1,881 |
|
45 |
|
42 |
|
420 |
|
21 |
|
30 |
Brilinta |
|
1,324 |
|
(2) |
|
(1) |
|
744 |
|
— |
|
285 |
|
— |
|
10 |
|
271 |
|
(4) |
|
(5) |
|
24 |
|
(49) |
|
(47) |
Lokelma |
|
412 |
|
43 |
|
46 |
|
214 |
|
26 |
|
50 |
|
n/m |
|
n/m |
|
58 |
|
94 |
|
91 |
|
90 |
|
32 |
|
42 |
roxadustat |
|
271 |
|
38 |
|
45 |
|
— |
|
— |
|
271 |
|
38 |
|
45 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Andexxa* |
|
182 |
|
21 |
|
23 |
|
75 |
|
(2) |
|
— |
|
— |
|
— |
|
62 |
|
50 |
|
47 |
|
45 |
|
39 |
|
50 |
Crestor |
|
1,107 |
|
6 |
|
11 |
|
55 |
|
(16) |
|
862 |
|
9 |
|
15 |
|
52 |
|
26 |
|
25 |
|
138 |
|
(7) |
|
- |
Seloken/Toprol-XL |
|
640 |
|
(26) |
|
(20) |
|
1 |
|
n/m |
|
621 |
|
(26) |
|
(20) |
|
11 |
|
(18) |
|
(17) |
|
7 |
|
(23) |
|
(19) |
Onglyza |
|
227 |
|
(12) |
|
(8) |
|
49 |
|
(36) |
|
131 |
|
8 |
|
16 |
|
32 |
|
(16) |
|
(17) |
|
15 |
|
(30) |
|
(28) |
Bydureon |
|
163 |
|
(42) |
|
(42) |
|
133 |
|
(45) |
|
3 |
|
12 |
|
12 |
|
27 |
|
(24) |
|
(26) |
|
- |
|
- |
|
- |
Others |
|
296 |
|
(19) |
|
(17) |
|
30 |
|
(10) |
|
152 |
|
(22) |
|
(18) |
|
109 |
|
(15) |
|
(15) |
|
5 |
|
(52) |
|
(49) |
Total CVRM |
|
10,585 |
|
15 |
|
18 |
|
2,752 |
|
11 |
|
4,586 |
|
11 |
|
18 |
|
2,503 |
|
31 |
|
29 |
|
744 |
|
9 |
|
16 |
BioPharmaceuticals: Respiratory & Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort |
|
2,362 |
|
(7) |
|
(4) |
|
726 |
|
(25) |
|
753 |
|
24 |
|
33 |
|
549 |
|
(6) |
|
(7) |
|
334 |
|
(11) |
|
(7) |
Fasenra |
|
1,553 |
|
11 |
|
12 |
|
992 |
|
9 |
|
64 |
|
50 |
|
61 |
|
355 |
|
16 |
|
14 |
|
142 |
|
— |
|
6 |
Breztri |
|
677 |
|
70 |
|
73 |
|
383 |
|
60 |
|
161 |
|
75 |
|
85 |
|
81 |
|
n/m |
|
n/m |
|
52 |
|
55 |
|
66 |
Saphnelo |
|
280 |
|
n/m |
|
n/m |
|
260 |
|
n/m |
|
2 |
|
n/m |
|
n/m |
|
8 |
|
n/m |
|
n/m |
|
10 |
|
n/m |
|
n/m |
Tezspire |
|
86 |
|
n/m |
|
n/m |
|
— |
|
— |
|
1 |
|
n/m |
|
n/m |
|
48 |
|
n/m |
|
n/m |
|
37 |
|
n/m |
|
n/m |
Pulmicort |
|
713 |
|
11 |
|
17 |
|
28 |
|
(58) |
|
575 |
|
25 |
|
34 |
|
68 |
|
(1) |
|
(2) |
|
42 |
|
(15) |
|
(10) |
Bevespi |
|
58 |
|
— |
|
— |
|
34 |
|
(19) |
|
6 |
|
19 |
|
28 |
|
17 |
|
65 |
|
62 |
|
1 |
|
50 |
|
14 |
Daliresp |
|
54 |
|
(72) |
|
(72) |
|
42 |
|
(76) |
|
3 |
|
(7) |
|
(11) |
|
8 |
|
(9) |
|
(11) |
|
1 |
|
(48) |
|
(20) |
Others |
|
324 |
|
(23) |
|
(20) |
|
82 |
|
(42) |
|
206 |
|
(10) |
|
(5) |
|
30 |
|
(29) |
|
(30) |
|
6 |
|
1 |
|
5 |
Total Respiratory & Immunology |
|
6,107 |
|
6 |
|
8 |
|
2,547 |
|
(4) |
|
1,771 |
|
23 |
|
31 |
|
1,164 |
|
10 |
|
8 |
|
625 |
|
2 |
|
8 |
BioPharmaceuticals: Vaccines & Immune Therapies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 mAbs |
|
132 |
|
(94) |
|
(93) |
|
— |
|
n/m |
|
6 |
|
(99) |
|
(99) |
|
12 |
|
(96) |
|
(96) |
|
114 |
|
(72) |
|
(68) |
Vaxzevria |
|
12 |
|
(99) |
|
(99) |
|
— |
|
n/m |
|
10 |
|
(99) |
|
(99) |
|
2 |
|
n/m |
|
(99) |
|
— |
|
n/m |
|
n/m |
Beyfortus |
|
106 |
|
n/m |
|
n/m |
|
87 |
|
n/m |
|
— |
|
— |
|
— |
|
19 |
|
n/m |
|
n/m |
|
— |
|
— |
|
— |
Synagis |
|
546 |
|
(6) |
|
(2) |
|
(1) |
|
n/m |
|
195 |
|
13 |
|
19 |
|
175 |
|
(18) |
|
(18) |
|
177 |
|
(7) |
|
(1) |
FluMist |
|
216 |
|
24 |
|
17 |
|
23 |
|
10 |
|
1 |
|
9 |
|
(2) |
|
188 |
|
25 |
|
17 |
|
4 |
|
74 |
|
80 |
Total Vaccines & Immune Therapies |
|
1,012 |
|
(79) |
|
(78) |
|
109 |
|
(91) |
|
212 |
|
(84) |
|
(83) |
|
396 |
|
(61) |
|
(62) |
|
295 |
|
(76) |
|
(74) |
Rare Disease*: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Soliris* |
|
3,145 |
|
(16) |
|
(14) |
|
1,734 |
|
(20) |
|
424 |
|
41 |
|
63 |
|
670 |
|
(17) |
|
(18) |
|
317 |
|
(33) |
|
(29) |
Ultomiris* |
|
2,965 |
|
51 |
|
52 |
|
1,750 |
|
54 |
|
71 |
|
88 |
|
89 |
|
668 |
|
39 |
|
36 |
|
476 |
|
54 |
|
65 |
Strensiq* |
|
1,152 |
|
20 |
|
21 |
|
937 |
|
22 |
|
40 |
|
15 |
|
22 |
|
89 |
|
14 |
|
11 |
|
86 |
|
13 |
|
22 |
Koselugo |
|
331 |
|
59 |
|
60 |
|
195 |
|
20 |
|
59 |
|
n/m |
|
n/m |
|
53 |
|
n/m |
|
n/m |
|
24 |
|
n/m |
|
n/m |
Kanuma* |
|
171 |
|
7 |
|
8 |
|
85 |
|
10 |
|
29 |
|
(7) |
|
(1) |
|
49 |
|
12 |
|
10 |
|
8 |
|
2 |
|
9 |
Total Rare Disease |
|
7,764 |
|
10 |
|
12 |
|
4,701 |
|
9 |
|
623 |
|
45 |
|
62 |
|
1,529 |
|
7 |
|
5 |
|
911 |
|
5 |
|
12 |
Other medicines |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium |
|
945 |
|
(27) |
|
(22) |
|
115 |
|
(5) |
|
578 |
|
2 |
|
9 |
|
53 |
|
16 |
|
13 |
|
199 |
|
(64) |
|
(61) |
Others |
|
231 |
|
(32) |
|
(30) |
|
18 |
|
(22) |
|
153 |
|
(31) |
|
(28) |
|
52 |
|
(33) |
|
(32) |
|
8 |
|
(58) |
|
(55) |
Total Other medicines |
|
1,176 |
|
(28) |
|
(24) |
|
133 |
|
(8) |
|
731 |
|
(7) |
|
(1) |
|
105 |
|
(14) |
|
(15) |
|
207 |
|
(64) |
|
(61) |
Total Product Sales |
|
43,789 |
|
2 |
|
4 |
|
17,961 |
|
4 |
|
11,751 |
|
1 |
|
8 |
|
9,029 |
|
9 |
|
7 |
|
5,048 |
|
(14) |
|
(8) |
23
|
|
World |
|
US |
|
Emerging Markets |
|
Europe |
|
Established ROW |
||||||||||||||||||
|
|
Sales |
|
Actual |
|
CER |
|
Sales |
|
Actual |
|
Sales |
|
Actual |
|
CER |
|
Sales |
|
Actual |
|
CER |
|
Sales |
|
Actual |
|
CER |
2022 |
|
$m |
|
% |
|
% |
|
$m |
|
% |
|
$m |
|
% |
|
% |
|
$m |
|
% |
|
% |
|
$m |
|
% |
|
% |
Oncology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso |
|
5,444 |
|
9 |
|
15 |
|
2,007 |
|
13 |
|
1,567 |
|
17 |
|
22 |
|
1,023 |
|
4 |
|
17 |
|
847 |
|
(7) |
|
8 |
Imfinzi |
|
2,784 |
|
15 |
|
21 |
|
1,552 |
|
25 |
|
287 |
|
4 |
|
7 |
|
544 |
|
12 |
|
26 |
|
401 |
|
(1) |
|
15 |
Lynparza |
|
2,638 |
|
12 |
|
18 |
|
1,226 |
|
13 |
|
488 |
|
27 |
|
31 |
|
655 |
|
6 |
|
19 |
|
269 |
|
4 |
|
20 |
Calquence |
|
2,057 |
|
66 |
|
69 |
|
1,657 |
|
52 |
|
45 |
|
n/m |
|
n/m |
|
286 |
|
n/m |
|
n/m |
|
69 |
|
n/m |
|
n/m |
Enhertu |
|
79 |
|
n/m |
|
n/m |
|
— |
|
— |
|
51 |
|
n/m |
|
n/m |
|
21 |
|
n/m |
|
n/m |
|
7 |
|
n/m |
|
n/m |
Orpathys |
|
33 |
|
n/m |
|
n/m |
|
— |
|
— |
|
33 |
|
n/m |
|
n/m |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Zoladex |
|
927 |
|
(2) |
|
6 |
|
15 |
|
15 |
|
657 |
|
6 |
|
12 |
|
133 |
|
(10) |
|
1 |
|
122 |
|
(28) |
|
(15) |
Faslodex |
|
334 |
|
(22) |
|
(14) |
|
17 |
|
(45) |
|
159 |
|
(4) |
|
3 |
|
55 |
|
(52) |
|
(46) |
|
103 |
|
(15) |
|
1 |
Iressa |
|
114 |
|
(38) |
|
(34) |
|
9 |
|
(19) |
|
94 |
|
(38) |
|
(35) |
|
2 |
|
(52) |
|
(41) |
|
9 |
|
(44) |
|
(35) |
Arimidex |
|
99 |
|
(29) |
|
(24) |
|
— |
|
— |
|
76 |
|
(29) |
|
(26) |
|
— |
|
(87) |
|
(86) |
|
23 |
|
(23) |
|
(11) |
Casodex |
|
78 |
|
(45) |
|
(40) |
|
— |
|
— |
|
53 |
|
(50) |
|
(47) |
|
1 |
|
(49) |
|
(48) |
|
24 |
|
(31) |
|
(19) |
Others |
|
44 |
|
(14) |
|
(6) |
|
1 |
|
59 |
|
27 |
|
(6) |
|
1 |
|
6 |
|
(4) |
|
4 |
|
10 |
|
(36) |
|
(26) |
Total Oncology |
|
14,631 |
|
13 |
|
19 |
|
6,484 |
|
23 |
|
3,537 |
|
10 |
|
14 |
|
2,726 |
|
10 |
|
23 |
|
1,884 |
|
(5) |
|
10 |
BioPharmaceuticals: CVRM |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga |
|
4,381 |
|
46 |
|
56 |
|
1,071 |
|
46 |
|
1,665 |
|
39 |
|
47 |
|
1,297 |
|
60 |
|
81 |
|
348 |
|
32 |
|
49 |
Brilinta |
|
1,358 |
|
(8) |
|
(4) |
|
744 |
|
1 |
|
286 |
|
(13) |
|
(10) |
|
282 |
|
(18) |
|
(8) |
|
46 |
|
(27) |
|
(22) |
Lokelma |
|
289 |
|
65 |
|
75 |
|
170 |
|
47 |
|
20 |
|
n/m |
|
n/m |
|
30 |
|
n/m |
|
n/m |
|
69 |
|
55 |
|
83 |
roxadustat |
|
197 |
|
13 |
|
18 |
|
— |
|
— |
|
197 |
|
13 |
|
18 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Andexxa* |
|
150 |
|
5 |
|
14 |
|
77 |
|
(32) |
|
— |
|
— |
|
— |
|
41 |
|
41 |
|
58 |
|
32 |
|
n/m |
|
n/m |
Crestor |
|
1,048 |
|
(4) |
|
2 |
|
65 |
|
(19) |
|
794 |
|
2 |
|
9 |
|
41 |
|
(21) |
|
(12) |
|
148 |
|
(21) |
|
(10) |
Seloken/Toprol-XL |
|
862 |
|
(9) |
|
(4) |
|
— |
|
n/m |
|
839 |
|
(10) |
|
(4) |
|
14 |
|
26 |
|
27 |
|
9 |
|
(16) |
|
(13) |
Bydureon |
|
280 |
|
(27) |
|
(26) |
|
242 |
|
(24) |
|
3 |
|
(16) |
|
(18) |
|
35 |
|
(37) |
|
(29) |
|
— |
|
(95) |
|
(94) |
Onglyza |
|
257 |
|
(28) |
|
(25) |
|
76 |
|
(13) |
|
121 |
|
(32) |
|
(28) |
|
38 |
|
(37) |
|
(29) |
|
22 |
|
(32) |
|
(30) |
Others |
|
366 |
|
(10) |
|
(7) |
|
34 |
|
(35) |
|
194 |
|
(1) |
|
4 |
|
128 |
|
(12) |
|
(10) |
|
10 |
|
(32) |
|
(24) |
Total CVRM |
|
9,188 |
|
13 |
|
19 |
|
2,479 |
|
11 |
|
4,119 |
|
9 |
|
15 |
|
1,906 |
|
25 |
|
40 |
|
684 |
|
10 |
|
25 |
BioPharmaceuticals: Respiratory & Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort |
|
2,538 |
|
(7) |
|
(2) |
|
973 |
|
(9) |
|
608 |
|
— |
|
5 |
|
582 |
|
(13) |
|
(3) |
|
375 |
|
(2) |
|
5 |
Fasenra |
|
1,396 |
|
11 |
|
15 |
|
906 |
|
15 |
|
43 |
|
n/m |
|
n/m |
|
305 |
|
7 |
|
20 |
|
142 |
|
(12) |
|
(1) |
Breztri |
|
398 |
|
96 |
|
n/m |
|
239 |
|
n/m |
|
92 |
|
68 |
|
75 |
|
33 |
|
n/m |
|
n/m |
|
34 |
|
32 |
|
56 |
Saphnelo |
|
116 |
|
n/m |
|
n/m |
|
111 |
|
n/m |
|
— |
|
— |
|
— |
|
2 |
|
n/m |
|
n/m |
|
3 |
|
n/m |
|
n/m |
Tezspire |
|
4 |
|
n/m |
|
n/m |
|
— |
|
— |
|
— |
|
— |
|
— |
|
2 |
|
n/m |
|
n/m |
|
2 |
|
n/m |
|
n/m |
Pulmicort |
|
645 |
|
(33) |
|
(31) |
|
65 |
|
(9) |
|
462 |
|
(40) |
|
(39) |
|
69 |
|
(6) |
|
6 |
|
49 |
|
5 |
|
15 |
Daliresp |
|
189 |
|
(17) |
|
(16) |
|
176 |
|
(15) |
|
3 |
|
(28) |
|
(24) |
|
9 |
|
(39) |
|
(32) |
|
1 |
|
3 |
|
7 |
Bevespi |
|
58 |
|
7 |
|
9 |
|
42 |
|
7 |
|
5 |
|
31 |
|
38 |
|
10 |
|
(7) |
|
5 |
|
1 |
|
n/m |
|
n/m |
Others |
|
421 |
|
(29) |
|
(27) |
|
143 |
|
32 |
|
230 |
|
(20) |
|
(17) |
|
42 |
|
(77) |
|
(75) |
|
6 |
|
(53) |
|
(46) |
Total Respiratory & Immunology |
|
5,765 |
|
(4) |
|
— |
|
2,655 |
|
10 |
|
1,443 |
|
(18) |
|
(14) |
|
1,054 |
|
(15) |
|
(5) |
|
613 |
|
(3) |
|
7 |
BioPharmaceuticals: Vaccines & Immune Therapies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaxzevria |
|
1,798 |
|
(54) |
|
(52) |
|
79 |
|
24 |
|
729 |
|
(67) |
|
(67) |
|
365 |
|
(65) |
|
(61) |
|
625 |
|
8 |
|
17 |
Evusheld |
|
2,185 |
|
n/m |
|
n/m |
|
1,067 |
|
n/m |
|
413 |
|
n/m |
|
n/m |
|
298 |
|
n/m |
|
n/m |
|
407 |
|
n/m |
|
n/m |
Synagis |
|
578 |
|
41 |
|
59 |
|
1 |
|
(94) |
|
173 |
|
n/m |
|
n/m |
|
213 |
|
5 |
|
17 |
|
191 |
|
28 |
|
51 |
FluMist |
|
175 |
|
(31) |
|
(20) |
|
21 |
|
(21) |
|
1 |
|
(51) |
|
(54) |
|
151 |
|
(32) |
|
(20) |
|
2 |
|
(4) |
|
(10) |
Total Vaccines & Immune Therapies |
|
4,736 |
|
2 |
|
8 |
|
1,168 |
|
n/m |
|
1,316 |
|
(43) |
|
(41) |
|
1,027 |
|
(33) |
|
(24) |
|
1,225 |
|
68 |
|
89 |
Rare Disease*: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Soliris* |
|
3,762 |
|
(11) |
|
(5) |
|
2,180 |
|
(7) |
|
301 |
|
(29) |
|
(10) |
|
805 |
|
(21) |
|
(12) |
|
476 |
|
11 |
|
24 |
Ultomiris* |
|
1,965 |
|
34 |
|
42 |
|
1,136 |
|
35 |
|
38 |
|
n/m |
|
n/m |
|
481 |
|
49 |
|
68 |
|
310 |
|
6 |
|
26 |
Strensiq* |
|
958 |
|
16 |
|
18 |
|
769 |
|
19 |
|
35 |
|
41 |
|
31 |
|
78 |
|
(3) |
|
9 |
|
76 |
|
(1) |
|
16 |
Koselugo |
|
208 |
|
93 |
|
96 |
|
162 |
|
55 |
|
26 |
|
n/m |
|
n/m |
|
20 |
|
n/m |
|
n/m |
|
— |
|
— |
|
— |
Kanuma* |
|
160 |
|
16 |
|
19 |
|
77 |
|
12 |
|
31 |
|
73 |
|
61 |
|
44 |
|
(3) |
|
10 |
|
8 |
|
21 |
|
38 |
Total Rare Disease |
|
7,053 |
|
4 |
|
10 |
|
4,324 |
|
8 |
|
431 |
|
(10) |
|
6 |
|
1,428 |
|
(3) |
|
9 |
|
870 |
|
8 |
|
24 |
Other medicines |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium |
|
1,285 |
|
(3) |
|
8 |
|
120 |
|
(6) |
|
568 |
|
(19) |
|
(13) |
|
46 |
|
(26) |
|
(17) |
|
551 |
|
28 |
|
50 |
Others |
|
340 |
|
(10) |
|
(7) |
|
24 |
|
(45) |
|
220 |
|
4 |
|
7 |
|
77 |
|
(29) |
|
(27) |
|
19 |
|
37 |
|
54 |
Total Other medicines |
|
1,625 |
|
(5) |
|
4 |
|
144 |
|
(16) |
|
788 |
|
(14) |
|
(9) |
|
123 |
|
(28) |
|
(24) |
|
570 |
|
28 |
|
50 |
Total Product Sales |
|
42,998 |
|
18 |
|
24 |
|
17,254 |
|
44 |
|
11,634 |
|
(4) |
|
1 |
|
8,264 |
|
9 |
|
22 |
|
5,846 |
|
22 |
|
40 |
24
From 1 January 2022, the Group reported Andexxa in CVRM, Koselugo in Rare Disease and Synagis and Flumist in Vaccines & Immune Therapies. In the “Sales by Region in 2023” section below, the 2023 figures and the comparative 2022 figures for these products are presented within their current therapy areas.
|
|
World |
|
US |
|
Emerging Markets |
|
Europe |
|
Established ROW |
||||||||||||||||||
|
|
Sales |
|
Actual |
|
CER |
|
Sales |
|
Actual |
|
Sales |
|
Actual |
|
CER |
|
Sales |
|
Actual |
|
CER |
|
Sales |
|
Actual |
|
CER |
2021 |
|
$m |
|
% |
|
% |
|
$m |
|
% |
|
$m |
|
% |
|
% |
|
$m |
|
% |
|
% |
|
$m |
|
% |
|
% |
Oncology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso |
|
5,015 |
|
16 |
|
13 |
|
1,780 |
|
14 |
|
1,336 |
|
11 |
|
6 |
|
986 |
|
32 |
|
25 |
|
913 |
|
13 |
|
14 |
Imfinzi |
|
2,412 |
|
18 |
|
16 |
|
1,245 |
|
5 |
|
277 |
|
76 |
|
68 |
|
485 |
|
31 |
|
25 |
|
405 |
|
23 |
|
23 |
Lynparza |
|
2,348 |
|
32 |
|
30 |
|
1,087 |
|
24 |
|
384 |
|
45 |
|
41 |
|
618 |
|
42 |
|
35 |
|
259 |
|
29 |
|
28 |
Calquence |
|
1,238 |
|
n/m |
|
n/m |
|
1,089 |
|
n/m |
|
20 |
|
n/m |
|
n/m |
|
111 |
|
n/m |
|
n/m |
|
18 |
|
n/m |
|
n/m |
Koselugo |
|
108 |
|
n/m |
|
n/m |
|
104 |
|
n/m |
|
1 |
|
n/m |
|
n/m |
|
3 |
|
n/m |
|
n/m |
|
— |
|
— |
|
— |
Enhertu |
|
17 |
|
n/m |
|
n/m |
|
— |
|
— |
|
12 |
|
n/m |
|
n/m |
|
4 |
|
n/m |
|
n/m |
|
1 |
|
n/m |
|
n/m |
Orpathys |
|
16 |
|
n/m |
|
n/m |
|
— |
|
— |
|
16 |
|
n/m |
|
n/m |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Zoladex |
|
948 |
|
7 |
|
3 |
|
13 |
|
n/m |
|
619 |
|
10 |
|
5 |
|
147 |
|
5 |
|
(1) |
|
169 |
|
(7) |
|
(7) |
Faslodex |
|
431 |
|
(26) |
|
(27) |
|
30 |
|
(46) |
|
167 |
|
(8) |
|
(10) |
|
113 |
|
(49) |
|
(52) |
|
121 |
|
(2) |
|
(1) |
Iressa |
|
183 |
|
(32) |
|
(35) |
|
11 |
|
(23) |
|
151 |
|
(31) |
|
(35) |
|
5 |
|
(58) |
|
(60) |
|
16 |
|
(26) |
|
(26) |
Casodex |
|
143 |
|
(17) |
|
(21) |
|
— |
|
— |
|
105 |
|
(21) |
|
(26) |
|
3 |
|
(3) |
|
6 |
|
35 |
|
(3) |
|
(3) |
Arimidex |
|
139 |
|
(25) |
|
(27) |
|
— |
|
— |
|
106 |
|
(28) |
|
(31) |
|
4 |
|
5 |
|
7 |
|
29 |
|
(15) |
|
(14) |
Others |
|
50 |
|
1 |
|
(1) |
|
— |
|
— |
|
29 |
|
3 |
|
1 |
|
5 |
|
51 |
|
43 |
|
16 |
|
(16) |
|
(15) |
Total Oncology |
|
13,048 |
|
20 |
|
18 |
|
5,359 |
|
26 |
|
3,223 |
|
11 |
|
6 |
|
2,484 |
|
28 |
|
22 |
|
1,982 |
|
13 |
|
13 |
BioPharmaceuticals: CVRM |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga |
|
3,000 |
|
53 |
|
49 |
|
732 |
|
29 |
|
1,195 |
|
74 |
|
70 |
|
810 |
|
60 |
|
52 |
|
263 |
|
34 |
|
31 |
Brilinta |
|
1,472 |
|
(8) |
|
(10) |
|
735 |
|
1 |
|
328 |
|
(29) |
|
(31) |
|
346 |
|
1 |
|
(4) |
|
63 |
|
8 |
|
(1) |
Bydureon |
|
385 |
|
(14) |
|
(15) |
|
321 |
|
(16) |
|
3 |
|
(25) |
|
(26) |
|
55 |
|
5 |
|
— |
|
6 |
|
(40) |
|
(44) |
Onglyza |
|
360 |
|
(23) |
|
(26) |
|
88 |
|
(47) |
|
179 |
|
(11) |
|
(14) |
|
61 |
|
5 |
|
(1) |
|
32 |
|
(29) |
|
(33) |
Byetta |
|
55 |
|
(19) |
|
(19) |
|
26 |
|
(31) |
|
12 |
|
61 |
|
75 |
|
11 |
|
(20) |
|
(25) |
|
6 |
|
(36) |
|
(38) |
Other diabetes |
|
59 |
|
26 |
|
24 |
|
22 |
|
(12) |
|
18 |
|
n/m |
|
n/m |
|
17 |
|
35 |
|
31 |
|
2 |
|
11 |
|
12 |
Lokelma |
|
175 |
|
n/m |
|
n/m |
|
115 |
|
n/m |
|
3 |
|
(44) |
|
(48) |
|
13 |
|
n/m |
|
n/m |
|
44 |
|
n/m |
|
n/m |
roxadustat |
|
174 |
|
n/m |
|
n/m |
|
— |
|
— |
|
174 |
|
n/m |
|
n/m |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Crestor |
|
1,096 |
|
(7) |
|
(10) |
|
80 |
|
(13) |
|
775 |
|
4 |
|
— |
|
52 |
|
(60) |
|
(62) |
|
189 |
|
(11) |
|
(10) |
Seloken/Toprol-XL |
|
951 |
|
16 |
|
10 |
|
1 |
|
(89) |
|
928 |
|
19 |
|
13 |
|
11 |
|
(33) |
|
(33) |
|
11 |
|
9 |
|
(3) |
Atacand |
|
97 |
|
(60) |
|
(60) |
|
4 |
|
(65) |
|
28 |
|
(84) |
|
(84) |
|
65 |
|
87 |
|
86 |
|
— |
|
n/m |
|
n/m |
Others |
|
196 |
|
3 |
|
(2) |
|
— |
|
— |
|
137 |
|
9 |
|
3 |
|
53 |
|
(7) |
|
(8) |
|
6 |
|
(21) |
|
(25) |
Total CVRM |
|
8,020 |
|
13 |
|
10 |
|
2,124 |
|
2 |
|
3,780 |
|
18 |
|
14 |
|
1,494 |
|
22 |
|
16 |
|
622 |
|
7 |
|
5 |
BioPharmaceuticals: Respiratory & Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort |
|
2,728 |
|
— |
|
(2) |
|
1,065 |
|
4 |
|
609 |
|
7 |
|
4 |
|
670 |
|
(3) |
|
(8) |
|
384 |
|
(12) |
|
(17) |
Fasenra |
|
1,258 |
|
33 |
|
31 |
|
790 |
|
31 |
|
20 |
|
67 |
|
67 |
|
286 |
|
41 |
|
34 |
|
162 |
|
24 |
|
22 |
Pulmicort |
|
962 |
|
(3) |
|
(8) |
|
72 |
|
1 |
|
770 |
|
(3) |
|
(9) |
|
73 |
|
- |
|
(5) |
|
47 |
|
(13) |
|
(15) |
Daliresp |
|
227 |
|
5 |
|
4 |
|
207 |
|
9 |
|
4 |
|
— |
|
(2) |
|
15 |
|
(32) |
|
(37) |
|
1 |
|
(3) |
|
(10) |
Breztri |
|
203 |
|
n/m |
|
n/m |
|
115 |
|
n/m |
|
55 |
|
n/m |
|
n/m |
|
7 |
|
n/m |
|
n/m |
|
26 |
|
n/m |
|
n/m |
Bevespi |
|
54 |
|
12 |
|
12 |
|
39 |
|
(11) |
|
4 |
|
n/m |
|
n/m |
|
11 |
|
n/m |
|
n/m |
|
— |
|
— |
|
— |
Saphnelo |
|
8 |
|
n/m |
|
n/m |
|
8 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
Others |
|
594 |
|
49 |
|
42 |
|
108 |
|
n/m |
|
287 |
|
41 |
|
32 |
|
185 |
|
5 |
|
— |
|
14 |
|
1 |
|
(6) |
Total Respiratory & Immunology |
|
6,034 |
|
13 |
|
9 |
|
2,404 |
|
24 |
|
1,749 |
|
9 |
|
4 |
|
1,247 |
|
6 |
|
1 |
|
634 |
|
(2) |
|
(5) |
Rare Disease*: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Soliris* |
|
1,874 |
|
1 |
|
2 |
|
1,068 |
|
4 |
|
170 |
|
1 |
|
8 |
|
439 |
|
(8) |
|
(7) |
|
197 |
|
8 |
|
11 |
Ultomiris* |
|
688 |
|
27 |
|
29 |
|
381 |
|
20 |
|
9 |
|
n/m |
|
n/m |
|
169 |
|
73 |
|
74 |
|
129 |
|
4 |
|
11 |
Strensiq* |
|
378 |
|
13 |
|
13 |
|
297 |
|
13 |
|
10 |
|
81 |
|
78 |
|
36 |
|
2 |
|
3 |
|
35 |
|
9 |
|
14 |
Andexxa* |
|
68 |
|
(3) |
|
(3) |
|
50 |
|
(21) |
|
— |
|
— |
|
— |
|
18 |
|
7 |
|
6 |
|
— |
|
— |
|
— |
Kanuma* |
|
62 |
|
20 |
|
21 |
|
32 |
|
13 |
|
7 |
|
n/m |
|
n/m |
|
20 |
|
7 |
|
9 |
|
3 |
|
14 |
|
25 |
Total Rare Disease |
|
3,070 |
|
8 |
|
9 |
|
1,828 |
|
8 |
|
196 |
|
11 |
|
18 |
|
682 |
|
7 |
|
9 |
|
364 |
|
7 |
|
11 |
Other medicines |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium |
|
1,326 |
|
(11) |
|
(12) |
|
128 |
|
(24) |
|
705 |
|
(7) |
|
(10) |
|
62 |
|
(13) |
|
(18) |
|
431 |
|
(13) |
|
(12) |
Synagis |
|
410 |
|
10 |
|
13 |
|
23 |
|
(51) |
|
35 |
|
— |
|
— |
|
203 |
|
(38) |
|
(37) |
|
149 |
|
— |
|
— |
Flumist |
|
253 |
|
(14) |
|
(17) |
|
27 |
|
(62) |
|
2 |
|
15 |
|
2 |
|
222 |
|
1 |
|
(2) |
|
2 |
|
(50) |
|
(53) |
Losec/Prilosec |
|
180 |
|
(2) |
|
(7) |
|
1 |
|
(89) |
|
152 |
|
— |
|
(7) |
|
26 |
|
32 |
|
31 |
|
1 |
|
(82) |
|
(72) |
Seroquel XR/IR |
|
92 |
|
(21) |
|
(20) |
|
12 |
|
(30) |
|
46 |
|
(17) |
|
(15) |
|
29 |
|
2 |
|
2 |
|
5 |
|
(71) |
|
(67) |
Others |
|
106 |
|
(16) |
|
(19) |
|
30 |
|
(45) |
|
14 |
|
n/m |
|
n/m |
|
54 |
|
(5) |
|
(9) |
|
8 |
|
(13) |
|
(19) |
Total Other medicines |
|
2,367 |
|
(8) |
|
(10) |
|
221 |
|
(39) |
|
954 |
|
(2) |
|
(5) |
|
596 |
|
(17) |
|
(19) |
|
596 |
|
12 |
|
15 |
COVID-19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaxzevria |
|
3,917 |
|
n/m |
|
n/m |
|
64 |
|
n/m |
|
2,240 |
|
n/m |
|
n/m |
|
1,035 |
|
n/m |
|
n/m |
|
578 |
|
n/m |
|
n/m |
Evusheld |
|
85 |
|
n/m |
|
n/m |
|
— |
|
— |
|
19 |
|
n/m |
|
n/m |
|
66 |
|
n/m |
|
n/m |
|
— |
|
— |
|
— |
Total COVID-19 |
|
4,002 |
|
n/m |
|
n/m |
|
64 |
|
n/m |
|
2,259 |
|
n/m |
|
n/m |
|
1,101 |
|
n/m |
|
n/m |
|
578 |
|
n/m |
|
n/m |
Total Product Sales |
|
36,541 |
|
41 |
|
38 |
|
12,000 |
|
39 |
|
12,161 |
|
40 |
|
36 |
|
7,604 |
|
50 |
|
44 |
|
4,776 |
|
36 |
|
36 |
* |
Growth rates on Rare Disease medicines have been calculated by comparing post-acquisition revenues from 21 July 2021 with the corresponding prior year pre-acquisition revenues previously published by Alexion adjusted pro rata to match the post-acquisition period. |
All commentary in “—Geographical Review” relates to Product Sales. The market definitions used in the geographical areas review below are defined in the Glossary on pages 232 to 235 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024.
2023 in brief
Product Sales increased by 2% (CER: 4%) in 2023 to $43,789 million (2022: $42,998 million; 2021: $36,541 million) despite a decline of $3,839 million from Covid-19 medicine. Following completion of the Alexion acquisition on 21 July 2021, Rare Disease medicines generated $7,764 million in 2023, growing 10% (CER: 12%) as compared to 2022 and contributing 18% of AstraZeneca’s Total Product Sales.
25
Product Sales in the US increased by 4% to $17,961 million (2022: $17,254 million; 2021: $12,000 million) driven by strong performance of Oncology, CVRM and Rare Disease medicines. Sales of Rare Disease medicines in the US increased by 9% to $4,701 million (2022: $4,324 million, 2021: $1,882 million), representing 61% of total Rare Disease sales. This is largely driven by Product Sales of Ultomiris.
In 2023, Product Sales in Emerging Markets increased by 1% (CER: 8%) to $11,751 million (2022: $11,634 million; 2021: $12,161 million). Excluding COVID-19 medicines, Product Sales in Emerging Markets increased by 12% (CER: 20%) in the year to $11,735 million. China sales, comprising 50% of Emerging Markets sales, increased by 2% (CER: 8%) to $5,867 million (2022: $5,740 million; 2021: $5,995 million). This contributed to 13% of Product Sales in 2023.
Ex-China Emerging Markets Product Sales were stable at $5,884 million (increase of 8% at CER) (2022: $5,894 million; 2021: $6,166 million). Excluding COVID-19 medicines, Product Sales in Ex-China Emerging Markets increased by 23% in the year (CER: 34%) to $5,868 million, driven by Oncology medicines and Farxiga from CVRM. Product Sales of Vaxzevria in Ex-China Emerging Markets decreased by 99% (CER: 99%) to $10 million (2022: $729 million; 2021: $2,240 million) in the year. Product Sales of COVID-19 mAbs in Ex-China Emerging Markets decreased by 99% (CER: 99%) to $6 million (2022: $411 million; 2021: $19 million) in the year.
Product Sales in Europe increased by 9% (CER: 7%) to $9,029 million (2022: $8,264 million; 2021: $7,604 million). Sales of Rare Disease medicines comprised 17% of Europe Product Sales, which increased by 7% (CER: 5%) to $1,529 million in 2023. Oncology sales in Europe grew by 22% (CER: 20%) to $3,332 million (2022: $2,726 million; 2021: $2,484 million) and represented 37% of Europe sales, primarily driven by sales of Tagrisso, Lynparza and Imfinzi. Excluding COVID-19 medicines, Product Sales in Europe grew by 19% (CER: 16%) to $9,015 million.
Product Sales in the Established ROW region decreased by 14% (CER: 8%) to $5,048 million (2022: $5,846 million; 2021: $4,776 million) largely driven by the decline in Vaccines and Immune Therapies. Japan, comprising 72% of total Established ROW Product Sales, decreased by 9% (CER: 1%) to $3,654 million (2022: $4,007 million; 2021: $3,416 million), due to the decline in sales of COVID-19 medicines, Soliris and Nexium. Product Sales in Canada, which contributed 19% of total Established ROW Product Sales, decreased by 17% (CER: 14%) to $967 million (2022: $1,165 million; 2021: $772 million).
2022 in brief
Product Sales increased by 18% (CER: 24%) in 2022 to $42,998 million (2021: $36,541 million) including Vaccines & Immune Therapies revenues. Following completion of the Alexion acquisition on 21 July 2021, Rare Disease medicines generated $7,053 million, growing 4% (CER: 10%) on a pro-rata basis, and contributed to 16% of AstraZeneca’s Total Product Sales.
Product Sales in the US increased by 44% to $17,254 million (2021: $12,000 million) driven by strong performance of Oncology and CVRM medicines. Sales of Rare Disease medicines in the US increased to $4,324 million, representing 61% of total Rare Disease sales. This is largely driven by Product Sales of Ultomiris.
In 2022, Product Sales in Emerging Markets decreased by 4% (CER: increase of 1%) to $11,634 million (2021: $12,161 million). Excluding Vaxzevria, Product Sales in Emerging Markets increased by 10% (16% at CER) in the year to $10,905 million. China sales, comprising 49% of Emerging Markets sales, decreased by 4% (CER: 1%) to $5,740 million (2021: $5,995 million). This contributed to 13% of Product Sales in 2022.
Ex-China Emerging Markets Product Sales decreased by 4% (increase of 2% at CER) to $5,894 million (2021: $6,166 million). Excluding Vaxzevria sales, Product Sales in Ex-China Emerging Markets increased by 32% in the year (CER: 42%) to $5,165 million, driven by Oncology medicines and Farxiga from CVRM. Product Sales of Vaxzevria in Ex-China Emerging Markets generated $729 million in the year. Product Sales of Evusheld in Ex-China Emerging Markets generated $411 million in the year.
Product Sales in Europe increased by 9% (CER: 22%) to $8,264 million (2021: $7,604 million). Sales of Rare Disease medicines comprised 17% of Europe Product Sales, which decreased on a pro rata basis by 3% (CER: 9%) to $1,428 million in 2022. Oncology sales in Europe grew by 10% (CER: 23%) to $2,726 million (2021: $2,484 million) and represented 33% of Europe sales, primarily driven by sales of Tagrisso, Lynparza and Imfinzi. Vaxzevria Product Sales contributed $365 million, amounting to 4% of total Europe Product Sales and 20% to the total Vaxzevria Product Sales in 2022. Excluding Vaxzevria, Product Sales in Europe grew by 20% (35% at CER) to $7,899 million.
26
Product Sales in the Established ROW region increased by 22% (CER: 40%) to $5,846 million (2021: $4,776 million) largely driven by Soliris and Farxiga. Japan, comprising 69% of total Established ROW Product Sales, increased by 17% (CER: 39%) to $4,007 million (2021: $3,416 million), underpinned by sales of Vaxzevria, Evusheld and Nexium. Product Sales in Canada, which contributed 20% of total Established ROW Product Sales, increased by 51% (CER: 57%) to $1,165 million (2021: $772 million).
From 1 January 2022, the Group reported Andexxa in CVRM, Koselugo in Rare Disease and Synagis and Flumist in Vaccines & Immune Therapies. In the “Sales by Region in 2023” section below, the 2023 figures and the comparative 2022 figures for these products are presented within their current therapy areas.
2021 in brief
Product Sales increased by 41% (CER: 38%) in 2021 to $36,541 million including COVID-19 vaccine revenues. Product Sales excluding vaccines increased 26% (24% at CER) to $32,624 million. Growth was well balanced across AstraZeneca’s strategic areas of focus with double-digit growth in all major regions, including Emerging Markets, despite some headwinds in China. Following completion of the Alexion acquisition on 21 July 2021, Rare Disease medicines generated $3,070 million, growing 8% (CER: 9%) on a pro-rata basis, and contributed to 8% of AstraZeneca’s Total Product Sales.
In 2021, Product Sales in Emerging Markets increased by 40% (CER: 36%) to $12,161 million. Excluding Vaxzevria, Product Sales in Emerging Markets increased by 14% (10% CER) in the year to $9,921 million. China sales, comprising 49% of Emerging Markets sales, increased by 12% (CER: 4%) to $5,995 million. This contributed to 16% of Product Sales in 2021.
Ex-China Emerging Markets Product Sales increased by 85% (86% at CER) to $6,166 million. Excluding Vaxzezria sales, Product Sales in Ex-China Emerging Markets increased by 18% in the year (CER: 19%) to $3,926 million, driven by Oncology medicines and Farxiga. Product Sales of Vaxzevria in Ex-China Emerging Markets generated $2,240 million in the year.
Sales in the U.S. increased by 39% to $12,000 million driven by strong performance of Oncology and Respiratory & Immunology medicines. Sales of Rare Disease medicines in the U.S. post acquisition increased to $1,828 million, representing a pro rata increase of 8% thereby contributing to 60% of total Rare Disease sales. This is largely driven by Product Sales of Soliris.
Product Sales in Europe increased by 50% (CER: 44%) to $7,604 million. Sales of Rare Disease medicines comprised 9% of Europe Product Sales, which grew on a pro rata basis by 7% (CER: 9%) to $682 million in 2021. Oncology sales in Europe grew by 28% (CER: 22%) to $2,484 million and represented 33% of Europe sales, primarily driven by sales of Tagrisso, Lynparza and Imfinzi. Vaxzevria sales contributed $1,035 million, amounting to 14% of total Europe Product Sales and 26% to the total Vaxzevria sales in 2021.Excluding Vaxzevria, Product Sales in Europe grew by 30% (25% CER) to $6,568 million.
Sales in the Established ROW region increased by 36% (CER: 36%) to $4,776 million largely driven by Tagrisso and Imfinzi. Japan, comprising 72% of total Established ROW sales, increased by 31% (CER: 35%) to $3,416 million, underpinned by sales of Oncology. Sales in Canada, which contributed 16% of total Established ROW sales, increased by 28% (CER: 19%) to $772 million. Other Established ROW sales increased by 90% (CER: 76%) to $588 million in the year, largely driven by Vaxzevria.
The Group has ceased reporting New Medicines as a performance metric (Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri). In line with practice these medicines were reported within their respective disease areas.
Sales by Region in 2023
US
Product Sales in the US increased by 4% to $17,961 million (2022: $17,254 million; 2021: $12,000 million).
Oncology
Oncology sales in the US increased by 19% to $7,719 million (2022: $6,484 million; 2021: $5,255 million).
Tagrisso sales in the US increased by 13% to $2,276 million (2022: $2,007 million; 2021: $1,780 million). Performance benefitted from continued adjuvant and 1st-line demand growth.
27
Imfinzi sales in the US increased by 49% to $2,317 million (2022: $1,552 million; 2021: $1,245 million), benefitting from continued demand growth from new launches in GI, including BTC (TOPAZ-1) and HCC Stage IV NSCLC.
Lynparza sales in the US grew by 2% to $1,254 million (2022: $1,226 million; 2021: $1,087 million) as a result of increased growth within PARP inhibitor class, offset by declining class use following the label restriction in 2nd-line ovarian cancer effective September 2023.
Calquence sales in the US exhibited a strong performance with an increase of 10% to $1,815 million (2022: $1,657 million; 2021: $1,089 million), as a result of sustained BTKi leadership across front-line and relapsed refractory CLL, partly offset by continued GtN pressure within competitive class.
Truqap sales in the US were $6 million (2022: $nil; 2021: $nil), as a result of the US approval on 16th November 2023 in 2nd-line+ HR+ breast cancer.
Faslodex sales in the US increased by 87% to $31 million (2022: $17 million; 2021: $30 million).
CVRM
CVRM sales in the US increased by 11% to $2,752 million (2022: $2,479 million; 2021: $2,174 million).
In the US Farxiga sales grew by 35% to $1,451 million (2022: $1,071 million; 2021: $732 million), with the growth driven by heart failure and CKD for patients with and without type 2 diabetes resulting in an increasing market share. There was also favourable gross-to-net adjustment in Q4 2023.
Brilinta sales in the US was $744 million (2022: $744 million; 2021: $735 million), with volume growth driven by longer duration of treatment.
Lokelma sales in the US increased by 26% to $214 million (2022: $170 million; 2021: $115 million), reflecting strong demand growth.
Andexxa sales in the US declined by 2% to $75 million (2022: $77 million; 2021: $50 million).
Crestor sales in the US decreased by 16% to $55 million (2022: $65 million; 2021: $80 million).
U.S sales of Onglyza fell by 36% in the year to $49 million (2022: $76 million; 2021: $88 million) due to continued decline for DPP-IV class.
Bydureon sales in the US declined by 45% to $133 million (2022: $242 million; 2021: $321 million) due to continued competitive pressures.
Respiratory & Immunology
Respiratory & Immunology sales in the US decreased by 4% to $2,547 million (2022: $2,655 million; 2021: $2,404 million).
Symbicort sales in the US decreased by 25% to $726 million (2022: $973 million; 2021: $1,065 million) due to generic competition entering the US market in the third quarter of 2023.
Fasenra sales in the US increased by 9% to $992 million (2022: $906 million; 2021: $790 million), benefiting from maintained share of a growing market, leading to strong volume growth.
Breztri sales in the US increased by 60% to $383 million (2022: $239 million; 2021: $115 million), following consistent share growth within the FDC triple class in new-to-brand and the total market.
Saphnelo sales in the US amounted to $260 million (2022: $111 million; 2021: $8 million) as a result of demand acceleration in the US.
Pulmicort sales in the US decreased by 58% to $28 million (2022: $65 million; 2021: $72 million).
Bevespi sales in the US decreased by 19% to $34 million (2022: $42 million; 2021: $39 million).
Daliresp/Daxas sales in the US decreased by 76% to $42 million (2022: $176 million; 2021: $207 million), impacted by uptake of multiple generics following loss of exclusivity in the US Vaccine & Immune Therapies in the US decreased by 91% to $109 million (2022: $1,168 million; 2021: $114 million), driven by a decline in sales of COVID-19 medicines.
28
Vaccines & Immune Therapies
COVID-19 mAbs sales in the US were $nil (2022: $1,067 million; 2021: $nil).
Vaxzevria sales in the US were $nil (2022: $79 million; 2021: $64 million), due to the fulfilment of contracts signed during the COVID-19 pandemic period.
Beyfortus sales in the US were $87 million (2022: $nil; 2021: $nil), as a result of AstraZeneca’s sales of manufactured Beyfortus product to Sanofi.
FluMist sales in the US increased by 10% to $23 million in the year (2022: $21 million; 2021: $27 million).
Rare Disease
Rare Disease sales in the US increased by 9% to $4,701 million (2022: $4,324 million; 2021: $1,882 million).
Soliris sales in the US decreased by 20% to $1,734 million (2022: $2,180 million; 2021: $1,068 million), driven by successful conversion of Soliris patients to Ultomiris in PNH, aHUS and gMG, partially offset by Soliris growth in NMOSD.
Ultomiris sales in the US increased by 54% to $1,750 million (2022: $1,136 million; 2021: $381 million), as a result of growth in naïve patients in gMG as well as successful conversion from Soliris across shared indications.
Strensiq sales in the US increased by 22% to $937 million (2022: $769 million; 2021: $297 million). Performance benefitted from strong patient demand.
Koselugo sales in the US increased by 20% to $195 million (2022: $162 million; 2021: $104 million;) driven by patient demand.
Kanuma sales in the US increased by 10% to $85 million (2022: $77 million; 2021: $32 million).
Other
Other medicines sales in the US decreased by 8% to $133 million (2022: $144 million; 2021: $171 million).
Nexium sales in the US decreased by 5% to $115 million (2022: $120 million; 2021: $128 million).
Emerging Markets
Product Sales in Emerging Markets increased by 1% (CER: 8%) to $11,751 million (2022: $11,634 million; 2021: $12,161 million).
Oncology
Oncology sales in Emerging Markets increased by 8% (CER: 16%) to $3,828 million (2022: $3,537 million; 2021: $3,222 million).
Tagrisso sales in Emerging Markets increased by 3% (CER: 10%) to $1,621 million (2022: $1,567 million; 2021: $1,336 million), as a result of continued demand growth partly offset by anticipated seasonality from hospital ordering dynamic in China.
Imfinzi sales in Emerging Markets increased by 25% (CER: 39%) to $360 million (2022: $287 million; 2021: $277 million) as a result of increased demand for new launches including BTC as well as continued demand for legacy indications Stage III unresectable NSCLC (PACIFIC), SCLC (CASPIAN).
Lynparza sales in Emerging Markets increased by 11% (CER: 21%) to $542 million (2022: $488 million; 2021: $384 million), benefiting from increased demand, offset by price reduction in China associated with NRDL renewal that took effect March 2023 for ovarian cancer indications (PSR and BRCAm 1st-line maintenance) and new NRDL enlistment in prostate cancer (PROfound).
Calquence sales in Emerging Markets were $98 million (2022: $45 million; 2021: $20 million).
29
Enhertu sales in Emerging Markets increased to $169 million (2022: $51 million; 2021: $12 million), as a result of continued uptake driven by approvals and launches, including strong demand growth in China following HER2-positive (DESTINY-Breast03) and HER2-low (DESTINY-Breast04) metastatic breast cancer launches.
Orpathys sales in Emerging Markets increased by 34% (CER: 42%) to $44 million (2022: $33 million; 2021: $16 million), due to its inclusion in the NRDL in China from March 2023 for the treatment of patients with NSCLC with MET exon 14 skipping alterations.
Zoladex sales in Emerging Markets increased by 5% (CER: 12%) to $687 million (2022: $657 million; 2021: $619 million) driven by strong underlying growth in China.
Faslodex sales in Emerging Markets fell by 11% (CER: 6%) to $142 million (2022: $159 million; 2021: $167 million) due to decline in China sales in fourth quarter due to supply issues, a consequence of short lead time of supply replenishment following VBP timeline changes.
CVRM
CVRM sales in Emerging Markets increased by 11% (CER: 18%) to $4,586 million (2022: $4,119 million; 2021: $3,780 million).
Forxiga sales in Emerging Markets increased by 33% (CER: 40%) to $2,211 million (2022: $1,665 million; 2021: $1,195 million) driven by solid growth despite generic competition in some markets and good momentum in Latin America.
Emerging Markets sales of Brilinta were stable at $285 million (CER: increase of 10%) (2022: $286 million; 2021: $328 million) and is holding positioning despite generics pressure.
Emerging Markets sales of roxadustat increased by 38% to $271 million (2022: $197 million; 2021: $174 million), benefitting from increased demand in both the dialysis- and non-dialysis-dependent populations as well as renewed NRDL listing.
Crestor sales in Emerging Markets increased by 9% (CER: 15%) to $862 million (2022: $794 million; 2021: $775 million).
Seloken sales in Emerging Markets declined by 26% (CER: 20%) to $621 million (2022: $839 million; 2021: $928 million).
Onglyza sales in Emerging Markets increased by 8% (CER: 16%) to $131 million (2022: $121 million; 2021: $179 million).
Bydureon sales in Emerging Markets increased by 12% (CER: 12%) to $3 million (2022: $3 million; 2021: $3 million).
Respiratory & Immunology
Respiratory & Immunology sales in Emerging Markets increased by 23% (CER: 31%) to $1,771 million (2022: $1,443 million; 2021: $1,749 million).
Emerging Markets sales of Symbicort increased by 24% (CER: 33%) to $753 million (CER: 5%) in the year (2022: $608 million; 2021: $609 million), as a result of strong underlying demand.
Fasenra sales in Emerging Markets increased by 50% (CER: 61%) to $64 million (2022: $43 million; 2021: $20 million) as a result of continued strong volume growth driven by launch acceleration across key markets.
Breztri sales in Emerging Markets increased by 75% (CER: 85%) to $161 million (2022: $92 million; 2021: $55 million) as a result of maintaining market share leadership in China with strong triple FDC class penetration.
Pulmicort sales in Emerging Markets increased by 25% (CER: 34%) to $575 million (2022: $462 million; 2021: $770 million) largely as a result of stabilized market share in China, with VBP having been in effect for over 12 months.
Bevespi sales in Emerging Markets increased by 19% (CER: 28%) to $6 million during the year (2022: $5 million; 2021: $4 million).
30
Daliresp sales in Emerging Markets declined by 7% (CER: 11%) to $3 million (2022: $3 million; 2021: $4 million).
Vaccines & Immune Therapies
Vaccines & Immune Therapies in Emerging Markets decreased by 84% (CER: 83%) to $212 million (2022: $1,316 million; 2021: $2,295 million).
COVID-19 mAbs sales in Emerging Markets decreased by 99% (CER: 99%) to $6 million (2022: $413 million; 2021: $19 million) and all sales were derived from sales of Evusheld.
Vaxzevria sales in Emerging Markets declined by 99% (CER: 99%) to $10 million (2022: $729 million; 2021: $2,240 million) due to the fulfilment of contracts signed during the COVID-19 pandemic.
Synagis sales in Emerging Markets increased by 13% (CER: 19%) to $195 million (2022: $173 million; 2021: $35 million), indicating that performance is broadly in line with prior year.
Rare Disease
Rare Disease sales in Emerging Markets increased by 45% (CER: 62%) to $623 million (2022: $431 million; 2021: $197 million).
Soliris sales in the Emerging Markets increased by 41% (CER: 63%) to $424 million (2022: $301 million; 2021: $170 million), as a result of growth following new market launches.
Ultomiris sales in the Emerging Markets increased by 88% (CER: 89%) to $71 million (2022: $38 million; 2021: $9 million), as a result of continued growth following launches in new markets.
Strensiq sales in the Emerging Markets increased by 15% (CER: 22%) to $40 million (2022: $35 million; 2021: $10 million), as a result of growth driven by strong demand.
Koselugo sales in the Emerging Markets increased to $59 million (2022: $26 million; 2021: $1 million), as a result of patient demand and expansion in new markets.
Kanuma sales in the Emerging Markets decreased by 7% (CER: 1%) to $29 million (2022: $31 million; 2021: $7 million).
Other
Other medicines sales in Emerging Markets decreased by 7% (CER: 1%) to $731 million (2022: $788 million; 2021: $917 million).
Nexium sales in Emerging Markets increased by 2% (CER: 9%) to $578 million (2022: $568 million; 2021: $705 million).
Europe
Product Sales in Europe increased by 9% (CER: 7%) to $9,029 million (2022: $8,264 million; 2021: $7,604 million).
Oncology
Oncology sales in Europe increased by 22% (CER: 20%) to $3,332 million (2022: $2,726 million; 2021: $2,481 million).
Tagrisso sales in Europe increased by 10% (CER: 8%) to $1,120 million (2022: $1,023 million; 2021: $986 million), driven by continued growth in 1st-line setting and increasing adjuvant demand.
Imfinzi sales in Europe increased by 39% (CER: 36%) to $758 million (2022: $544 million; 2021: $485 million), as a result of competitive share gain in SCLC, and expanded reimbursement for BTC, HCC, Stage IV NSCLC and SCLC.
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Lynparza sales in Europe increased by 12% (CER: 10%) to $734 million (2022: $655 million; 2021: $618 million), as a result of demand growth from increased uptake and new launches in 1st-line HRD-positive ovarian cancer (PAOLA-1), gBRCAm10 HER2-negative early breast cancer (OlympiA) and mCRPC (PROpel), offset by reduced use in 2nd-line ovarian cancer and pricing.
Calquence sales in Europe increased by 72% (CER: 69%) to $493 million (2022: $286 million; 2021: $111 million) as a result of continued growth supported by expanded access in key markets.
Enhertu sales in Europe increased to $60 million (2022: $21 million; 2021: $4 million) as a result of continued growth driven by increasing adoption in HER2-positive and HER2-low metastatic breast cancer.
Zoladex sales in Europe (CER: decrease of 1%) were stable at $133 million (2022: $133 million; 2021: $147 million), indicating a flat performance in Europe.
Faslodex sales in Europe decreased by 49% (CER: 50%) to $28 million (2022: $55 million; 2021: $113 million).
CVRM
CVRM sales in Europe increased by 31% (CER: 29%) to $2,503 million (2022: $1,906 million; 2021: $1,512 million).
Forxiga sales in Europe increased by 45% (CER: 42%) to $1,881 million (2022: $1,297 million; 2021: $810 million, benefitting from the addition of cardiovascular outcomes trial data to the label and growth in HFrEF, CKD and the HFpEF approval in February 2023 and updated ESC guidelines in August 2023 also include treatment of patients with HFpEF.
Brilique sales in Europe decreased by 4% (CER: 5%) to $271 million (2022: $282 million; 2021: $346 million) due to clawbacks.
Lokelma sales in Europe increased by 94% (CER: 91%) to $58 million (2022: $30 million; 2021: $13 million) as a result of strong demand growth.
Andexxa sales in the Europe increased by 50% (CER: 47%) to $62 million (2022: $41 million; 2021: $18 million)
Crestor sales in Europe increased by 26% (CER: 25%) to $52 million (2022: $41 million; 2021: $52 million).
Seloken /Toprol -XL sales in Europe decreased by 18% (CER: 17%) to $11 million (2022: $14 million; 2021: $11 million).
Onglyza sales in Europe decreased by 16% (CER: 17%) to $32 million (2022: $38 million; 2021: $61 million) due to continued decline for DPP-IV class.
Bydureon sales in Europe decreased by 24% (CER: 26%) to $27 million (2022: $35 million; 2021: $55 million) due to competitive pressures.
Respiratory & Immunology
Respiratory & Immunology sales in Europe increased by 10% (CER: 8%) to $1,164 million (2022: $1,054 million; 2021: $1,247 million).
Symbicort sales in Europe decreased by 6% (CER: 7%) to $549 million (2022: $582 million; 2021: $670 million), due to continued price and volume erosion from generics and a slowing overall market.
Fasenra sales in Europe increased by 16% (CER: 14%) to $355 million (2022: $305 million; 2021: $286 million), benefiting from expanded leadership in severe eosinophilic asthma.
Trixeo sales in Europe increased to $81 million (2022: $33 million; 2021: $7 million) as a result of sustained growth across markets as new launches continue to progress.
Saphnelo sales in Europe increased to $8 million (2022: $2 million; 2021: $nil) as a result of additional growth driven by ongoing launches in Europe.
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Tezspire sales in Europe increased to $48 million (2022: $2 million; 2021: $nil) as a result of achieving and maintaining new-to-brand leadership in key markets as well as pre-filled pen approved in January 2023.
Pulmicort sales in Europe declined by 1% (CER: 2%) to $68 million (2022: $69 million; 2021: $73 million).
Bevespi sales in Europe increased by 65% (CER: 62%) to $17 million (2022: $10 million; 2021: $11 million).
Daliresp/Daxas sales in Europe decreased by 9% (CER: 11%) to $8 million (2022: $9 million; 2021: $15 million).
Vaccines & Immune Therapies
Vaccines & Immune Therapies sales in Europe decreased by 61% (CER: 62%) to $396 million (2022: $1,027 million; 2021: $1,526 million).
COVID-19 mAbs sales in Europe decreased by 96% (CER: 96%) to $12 million (2022: $298 million; 2021: $66 million) and all sales were derived from sales of Evusheld.
Vaxzevria sales in Europe (CER: decrease of 99%) were $2 million (2022: $365 million; 2021: $1,035 million) due to the fulfilment of contracts signed during the COVID-19 pandemic period.
Beyfortus sales in Europe were $19 million (2022: $nil; 2021: $nil).
Synagis sales in Europe decreased by 18% (CER: 18%) to $175 million (2022: $213 million; 2021: $203 million).
FluMist sales in Europe increased by 25% (CER: 17%) to $188 million (2022: $151 million; 2021: $222 million).
Rare Disease
Rare Disease sales in Europe increased by 7% (CER: 5%) to $1,529 million (2022: $1,428 million; 2021: $667 million).
Soliris sales in Europe decreased by 17% (CER: 18%) to $670 million (2022: $805 million; 2021: $439 million), due to successful conversion from Soliris to Ultomiris, as well as biosimilar erosion in PNH.
Ultomiris sales in Europe increased by 39% (CER: 36%) to $668 million (2022: $481 million; 2021: $169 million), as result of strong demand generation following launches in new markets, particularly in neurology indications, as well as accelerated conversion from Soliris in key markets, partially offset by price reductions to secure reimbursement for new indications.
Strensiq sales in Europe increased by 14% (CER: 11%) to $89 million (2022: $78 million; 2021: $36 million), as a result of strong patient demand.
Koselugo sales in Europe were $53 million (2022: $20 million; 2021: $3 million), driven by patient demand and expansion in new markets.
Kanuma sales in Europe increased by 12% (CER: 10%) to $49 million (2022: $44 million; 2021: $20 million), as a result of continued demand growth.
Other
Other medicines sales in Europe decreased by 14% (CER: 15%) to $105 million (2022: $123 million; 2021: $171 million) due to continued impact of generic competition.
Nexium sales in Europe increased by 16% (CER: 13%) to $53 million (2022: $46 million; 2021: $62 million).
Established ROW
Product Sales in the Established ROW region decreased by 14% (CER: 8%) to $5,048 million (2022: $5,846 million; 2021: $4,776 million).
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Oncology
Oncology sales in the Established ROW region increased by 20% (CER: 29%) to $2,266 million (2022: $1,884 million; 2021: $1,982 million). Oncology sales in Japan increased by 20% (CER: 30%) to $1,804 million in the year (2022: $1,501 million; 2021: $1,665 million).
Tagrisso sales in the Established ROW region decreased by 8% (CER: 1%) to $782 million (2022: $847 million; 2021: $913 million) due to increased demand in adjuvant and 1st-line offset by continued impact from HSR price reduction in Japan effective June 2023 and reclassification of Australian government rebates from the fourth quarter of 2023. In Japan, sales of Tagrisso declined by 8% (stable at CER) to $639 million in the year (2022: $695 million; 2021: $775 million).
Imfinzi sales in the Established ROW region increased to $802 million (2022: $401 million; 2021: $405 million) as a result of growth driven by launch of BTC, HCC and Stage IV NSCLC in Japan. In Japan, sales of Imfinzi increased to $714 million (2022: $329 million; 2021: $345 million).
Lynparza sales in the Established ROW region increased by 5% (CER: 12%) to $281 million (2022: $269 million; 2021: $259 million) as a result of growth driven by increased uptake in testing and use in 1st-line HRD-positive ovarian cancer, partially offset by market expansion re-pricing in Japan from November 2023. Lynparza sales in Japan amounted to $210 million (2022: $203 million; 2021: $199 million), representing a growth of 3% (CER: 12%).
Calquence sales in the Established ROW region increased by 58% (CER: 65%) to $108 million (2022: $69 million; 2021: $18 million). Calquence sales in Japan amounted to $20 million (2022: $7 million; 2021: $3 million).
Enhertu sales in the Established ROW region increased to $32 million (2022: $7 million; 2021: $1 million).
Zoladex sales in the Established ROW region decreased by 4% (CER: increase of 2%) to $118 million (2022: $122 million; 2021: $169 million) due to a drop in sales in Japan. In Japan, Zoladex sales decreased by 22% (CER: 16%) to $83 million (2022: $107 million, 2021: $139 million).
Faslodex sales in the Established ROW region decreased by 7% (CER: increase of 1%) to $96 million (2022: $103 million; 2021: $121 million). In Japan, sales decreased by 6% (CER: increase of 2%) to $95 million (2022: $101 million; 2021: $118 million).
CVRM
CVRM sales in the Established ROW region increased by 9% (CER: 16%) to $744 million (2022: $684 million; 2021: $622 million).
Forxiga sales in the Established ROW region increased by 21% (CER: 30%) to $420 million (2022: $348 million; 2021: $263 million) as a result of continued volume growth driven by HF and CKD launches and generics launched in Canada in the third quarter of 2023. Japan sales grew by 38% (CER: 50%) to $298 million (2022: $215 million; 2021: $150 million).
Brilinta sales in the Established ROW region decreased by 49% (CER: 47%) to $24 million (2022: $46 million; 2021: $63 million) due to generic entry in Canada.
Lokelma sales in the Established ROW region increased by 32% (CER: 42%) to $90 million (2022: $69 million; 2021: $44 million) driven by strong demand growth. Sales in Japan increased by 32% (CER: 42%) to $88 million in the year (2022: $67 million; 2021: $43 million).
Andexxa sales in the Established ROW region increased by 39% (CER: 50%) to $45 million (2022: $32 million; 2021: $nil). Sales in Japan increased by 35% (CER: 46%) to $44 million in the year (2022: $33 million; 2021: $nil).
Crestor sales in the Established ROW region decreased by 7% (stable at CER) to $138 million (2022: $148 million; 2021: $189 million) with a decline in Japan sales by 8% (stable at CER) to $105 million (2022: $114 million; 2021: $151 million), where AstraZeneca collaborates with Shionogi.
Seloken/Toprol-XL sales in the Established ROW region showed a decrease by 23% (19% at CER) to $7 million (2022: $9 million; 2021: $11 million).
Onglyza sales in the Established ROW region declined by 30% (CER: 28%) to $15 million (2022: $22 million; 2021: $32 million).
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Bydureon sales in the Established ROW region was $nil (2022: $nil; 2021: $6 million).
Respiratory & Immunology
Respiratory & Immunology sales in the Established ROW region increased by 2% (CER: 8%) to $625 million (2022: $613 million; 2021: $634 million). Respiratory & Immunology sales in Japan increased by 8% (CER: 17%) to $241 million (2022: $222 million; 2021: $284 million) in the year.
Symbicort sales in the Established ROW region decreased by 11% (CER: 7%) to $334 million (2022: $375 million; 2021: $384 million). Sales in Japan declined by 20% (CER: 13%) to $65 million (2022: $81 million; 2021: $124 million) in the year due to generic erosion.
Fasenra sales in the Established ROW region (CER: increase of 6%) were stable at $142 million (2022: $142 million; 2021: $162 million). Sales in Japan declined by 7% (CER: increase if 1%) to $82 million (2022: $88 million; 2021: $110 million) in the year.
Breztri sales in the Established ROW region increased by 55% (CER: 66%) $52 million (2022: $34 million; 2021: $26 million) which is largely contributed by increased market share gains within COPD in Japan and strong launch performance in Canada. Sales in Japan increased by 22% (CER: 31%) to $37 million (2022: $31 million; 2021: $25 million).
Saphnelo sales in the Established ROW region increased to $10 million (2022: $3 million; 2021: $nil) which is largely contributed by additional growth from ongoing launches in Japan. Sales in Japan increased to $9 million (2022: $3 million; 2021: $nil).
Tezspire sales in the Established ROW region increased to $37 million (2022: $2 million; 2021: $nil) driven by Japan maintaining new-to-brand leadership. Sales in Japan increased to $30 million (2022: $2 million; 2021: $nil).
Pulmicort sales in the Established ROW region decreased by 15% (CER: 10%) to $42 million (2022: $49 million; 2021: $47 million). In Japan, sales decreased by 1% (CER: increase of 7%) in the year to $16 million (2022: $17 million, 2021: $23 million).
Vaccines & Immune Therapies
Vaccines & Immune Therapies sales in the Established ROW region decreased by 76% (CER: 74%) to $295 million (2022: $1,225 million; 2021: $730 million). Vaccines & Immune Therapies sales in Japan decreased by 69% (CER: 66%) to $234 million (2022: $756 million; 2021: $454 million) in the year.
COVID-19 mAbs sales in the Established ROW region declined by 72% (CER: 68%) to $114 million (2022: $407 million; 2021: $nil), with all product sales derived from sales of Evusheld. Sales in Japan were at $84 million (2022: $215 million; 2021: $nil).
Vaxzevria sales in the Established ROW region declined to $nil (2022: $625 million; 2021: $578 million) due to the fulfilment of contracts signed during the COVID-19 pandemic period. Sales in Japan declined to $nil (2022: $379 million; 2021: $323 million).
Synagis sales in the Established ROW region declined by 7% (CER:1%) to $177 million (2022: $191 million; 2021: $149 million). Sales in Japan declined by 7% (CER: 1%) to $150 million (2022: $162 million; 2021: $132 million).
Rare Disease
Rare Disease sales in the Established ROW region increased by 5% (CER: 12%) to $911 million (2022: $870 million; 2021: $364 million). Rare Disease sales in Japan increased by 17% (CER: 26%) to $675 million (2022: $578 million; 2021: $274 million).
Soliris sales in the Established ROW region decreased by 33% (CER: 29%) to $317 million (2022: $476 million; 2021: $197 million) driven by successful conversion from Soliris to Ultomiris. Soliris sales in Japan decreased by 41% (CER: 35%) to $133 million (2022: $224 million; 2021: $111 million).
Ultomiris sales in the Established ROW region increased by 54% (CER: 65%) to $476 million (2022: $310 million; 2021: $129 million), driven by continued conversion from Soliris and strong demand following new launches. Sales in Japan increased by 55% (CER: 67%) to $441 million (2022: $285 million; 2021: $130 million).
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Strensiq sales in the Established ROW region increased by 13% (CER: 22%) to $86 million (2022: $76 million; 2021: $35 million) driven by strong patient demand. Sales in Japan increased to $74 million (2022: $66 million; 2021: $31 million).
Koselugo sales in the Established ROW region increased to $24 million (2022: $nil; 2021: $nil) driven by patient demand and expansion in new markets. Sales in Japan increased to $23 million (2022: $nil; 2021: $nil).
Kanuma sales in the Established ROW region increased by 2% (CER: 9%) to $8 million (2022: $8 million; 2021: $3 million) driven by continued demand growth. Sales in Japan increased by 28% (CER: 39%) to $4 million (2022: $3 million; 2021: $2 million).
Other
Other medicines sales in the Established ROW region decreased by 64% (CER: 61%) to $207 million (2022: $570 million; 2021: $445 million). Sales in Japan decreased by 69% (CER: 67%) to $156 million (2022: $507 million; 2021: $376 million).
Nexium sales in the Established ROW region decreased by 64% (CER: 61%) to $199 million (2022: $551 million; 2021: $431 million) due to generic launches in Japan in the latter part of 2022. Sales in Japan decreased by 70% (67% at CER) to $150 million (2022: $497 million; 2021: $369 million), where AstraZeneca collaborated with Daiichi Sankyo until September 2021.
Disclosures Under the Iran Threat Reduction and Syria Human Rights Act of 2012
AstraZeneca is a global, innovation-driven biopharmaceutical business with operations in over 100 countries and its innovative medicines are used by millions of patients worldwide. AstraZeneca has a legal entity based in Iran, AstraZeneca Pars Company (“AstraZeneca Pars”), which has no employees, and is owned by non-US Group companies. In July 2017, AstraZeneca Pars submitted regulatory applications to the Iranian Food and Drug Administration and subsequently received marketing authorizations for several products. AstraZeneca Pars has not entered into any commercial transaction since its incorporation; products registered under AstraZeneca Pars are exclusively sold by a third-party distributor.
AstraZeneca, through one of its non-US Group companies that is neither a US person nor a foreign subsidiary of a US person, currently has sales of prescription pharmaceuticals in Iran solely through a single third-party distributor, which uses three known entities in the Iranian distribution chain. At this time, none of AstraZeneca’s US entities are involved in any business activities in Iran, or with the Iranian government. To the best knowledge of the management of AstraZeneca, the third-party distributor used by AstraZeneca is not owned or controlled by the Iranian government and AstraZeneca does not have any agreements, commercial arrangements, or other contracts with the Iranian government. However, AstraZeneca understands that one of the independent sub-distributors of AstraZeneca’s third-party distributor is likely to be indirectly controlled by the Iranian government. Further, AstraZeneca’s third-party distributor may initiate payments using banks associated with the government of Iran for the purchase of AstraZeneca products. Finally, Government agencies, hospitals and institutions may purchase AstraZeneca products from the third-party distributor or the sub-distributors.
Throughout 2017 to 2023, AstraZeneca, through a distributor, sponsored health care provider education programs in Iran, including for employees of hospitals owned or controlled by the Iranian Ministry of Health.
For the year ended December 31, 2023, the Company’s gross revenues and net profits attributable to the above-mentioned Iranian activities were $24 million and $8 million respectively. For the same period, AstraZeneca’s gross revenues and net profits were $45.8 billion and $6.0 billion, respectively. Accordingly, the gross revenues and net profits attributable to the above-mentioned Iranian activities amounted to approximately 0.05% of AstraZeneca’s gross revenues and approximately 0.13% of its net profits.
At the time of publication, the management of AstraZeneca does not anticipate any change in its activities in Iran that would result in a material impact on AstraZeneca.
C. Organizational Structure
The information (including tabular data) set forth under the headings “Additional Information—Directors’ Report—Subsidiaries and principal activities” on page 227, “—Branches and countries in which the Group conducts business” on page 227, and “Financial Statements—Group Subsidiaries and Holdings” on pages 211 to 215, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
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D. Property, Plant and Equipment
Please see the information below under the heading Item 5—“Operating and Financial Review and Prospects—Operating Results—2023 compared with 2022”. The information (including tabular data) set forth under the headings “Strategic Report—Business Review—Science and Innovation—Research and Development” on pages 34 to 35, “Strategic Report—Business Review—Growth in Therapy Area Leadership—Operations” on page 40, “Strategic Report—Business Review—Growth in Therapy Area Leadership—IT and IS resources” on page 41, “Financial Statements—Notes to the Group Financial Statements—Note 7—Property, plant and equipment” on pages 169 to 170, “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets—Environmental costs and liabilities” on page 204, and “Financial Statements—Notes to the Group Financial Statements—Note 8—Leases” on pages 170 to 171, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
Substantially all of the Group’s properties are held freehold, free of material encumbrances and are fit for their purpose. For more information, please refer to “Financial Statements—Notes to the Group Financial Statements—Note 7—Property, plant and equipment” on pages 169 to 170 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024.
ITEM 4A. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Our Strategy and Key Performance Indicators” on pages 12 to 15, “Financial Statements— Notes to the Group Financial Statements—Note 1—Revenue—Product Sales” on page 160, “Financial Statements—Notes to the Group Financial Statements—Note 28—Financial risk management objectives and policies” on pages 195 to 201, and “Additional Information—Important information for readers of this Annual Report” on page 236, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. The information contained herein under Item 8—“Summarized financial information for guarantee of securities of subsidiaries” is incorporated by reference. Please also see the information above under the heading Item 4—“Information on the Company— Business Overview—Geographical Review”.
A. Operating Results
2023 compared with 2022
The information set forth under the heading “Strategic Report—Financial Review” on pages 58 to 74 (excluding the information set forth under the subheadings “Full year 2024: additional commentary” and “Currency impact” on page 71) of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated herein by reference.
2022 compared with 2021
The information set forth under the heading “Strategic Report—Financial Review” on pages 60 to 76 of AstraZeneca’s “Annual Report and Form 20-F Information 2022” included as exhibit 15.1 to the Form 20-F dated February 21, 2023 is incorporated herein by reference.
B. Liquidity and capital resources
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Financial Review—Cash flow and liquidity—for the year ended 31 December 2023” and “—Summary cash flows” on page 68, “Strategic Report—Financial Review—Financial position – 31 December 2023” on pages 69 to 70, “Strategic Report—Financial Review—Capitalisation and shareholder return” on page 71, “Financial Statements—Notes to the Group Financial Statements—Note 19—Interest-bearing loans and borrowings” on pages 179 to 181, “Financial Statements—Notes to the Group Financial Statements—Note 13—Derivative financial instruments” on page 177, “Financial Statements—Notes to the Group Financial Statements—Note 23—Reserves” on page 191, “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
We consider the Group’s working capital to be sufficient for its present requirements.
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C. Research and development and Patent Protection and Licenses
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Business Review—Science and Innovation—Research and Development” on pages 34 to 35, “Strategic Report—Business Review—Science and Innovation—Development pipeline overview” on page 37, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. Please also see the information above under the headings Item 4—“Information on the Company— Business Overview—Development Pipeline as of February 8, 2024” and “—Patent Expiries of Key Marketed Products”.
D. Trend information
The information set forth in the introductory paragraph under the heading “Strategic Report—Financial Review” on page 58 and the information (including graphs and tabular data) set forth under the headings “Strategic Report—Our Strategy and Key Performance Indicators” on pages 12 to 15, “Strategic Report—Financial Review—Measuring performance” on pages 60 to 62, “Financial Statements— Notes to the Group Financial Statements—Note 1—Revenue—Product Sales” on page 160, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
E. Critical Accounting Estimates
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Financial Review—Critical accounting policies and estimates” on page 72, “Financial Statements—Group Accounting Policies” on page 152 to 159 and “Financial Statements— Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
The information (including tabular data) set forth under the headings “Corporate Governance—Board of Directors as at 31 December 2023” on pages 78 to 79, and “Corporate Governance—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 126, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
In addition to the Board of Directors, the Senior Executive Team, or SET, is the body through which the CEO exercises the authority delegated to him by the Board. The CEO leads the SET and has executive responsibility for the management, development and performance of the business. The CEO, CFO and SET also take the lead in developing the strategy for review, constructive challenge and approval by the Board as part of the annual strategy review process. The information set forth under the heading “Corporate Governance—Senior Executive Team (SET) as at 31 December 2023” on page 80 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
Senior Executive Team (SET) Biographies as at December 31, 2023
Sharon Barr – Executive Vice-President, Biopharmaceuticals R&D
Sharon was appointed as Executive Vice-President, BioPharmaceuticals R&D in August 2023. She is responsible for discovery through to late-stage development across CVRM and Respiratory & Immunology. Prior to this role, Sharon served as Senior Vice President, Head of Research and Product Development of Alexion, AstraZeneca Rare Disease having joined in 2013. With more than 18 years of industry experience she has previously led translational research, precision medicines, and global drug development teams. Sharon received her PhD in molecular biology from New York University, and completed a postdoctoral fellowship focused on mechanisms of DNA Damage and Repair at Stanford University. In 2022, Sharon was recognised as a Healthcare Businesswoman’s Association Luminary in recognition of her transformational leadership and passion for mentoring those around her.
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Pam Cheng – Executive Vice-President, Global Operations, IT & Chief Sustainability Officer
Pam was appointed Executive Vice-President, Operations & Information Technology in June 2015 and assumed additional responsibility for the AstraZeneca Sustainability strategy and function in January 2023. Pam joined AstraZeneca after having spent 18 years with Merck/MSD in Global Manufacturing and Supply Chain and Commercial roles. Pam was the Head of Global Supply Chain Management & Logistics for Merck and led the transformation of Merck supply chains across the global supply network. Pam also held the role of President of MSD China, responsible for MSD’s entire business in China. Prior to joining Merck, Pam held various engineering and project management positions at Universal Oil Products, Union Carbide Corporation and GAF Chemicals. Pam holds Bachelor’s and Master’s degrees in chemical engineering from Stevens Institute of Technology in New Jersey and an MBA in marketing from Pace University in New York. In addition to her role at AstraZeneca, Pam serves as a Non-Executive Director of the Smiths Group plc Board and as a Trustee Member of the Board for Stevens Institute of Technology. Pam also serves as an Advisor to the International Society of Pharmaceutical Engineering (ISPE) Board of Directors.
Ruud Dobber – Executive Vice-President, BioPharmaceuticals Business Unit
Ruud was appointed Executive Vice-President, BioPharmaceuticals Business Unit in January 2019 and is responsible for product strategy and commercial delivery for CVRM, Respiratory and Immunology, and Vaccines & Immune Therapies. Prior to this, Ruud held the role of Executive Vice-President, North America and was responsible for driving growth and maximising the contribution of the commercial operations in North America. Ruud joined Astra (later to become AstraZeneca) in 1997 and has assumed leadership roles with increasing responsibility including Executive Vice-President, North America; Executive Vice-President, Europe; Regional Vice-President, Europe, Middle East and Africa; and Regional Vice-President, Asia Pacific. Ruud served as a member of the board and executive committee of the European Federation of Pharmaceutical Industries and Associations and was previously Chairman of the Asia division of Pharmaceutical Research and Manufacturers of America. Ruud holds a doctorate in immunology from the University of Leiden, Netherlands, beginning his career as a research scientist in immunology and ageing.
Ruud was appointed as a non-executive director of the Board of Almirall S.A. in June 2021.
Marc Dunoyer – Chief Executive Officer, Alexion and Chief Strategy Officer, AstraZeneca
Marc became CEO of Alexion, AstraZeneca’s Rare Disease group, in August 2021 following its acquisition in July. He had previously served as an Executive Director and AstraZeneca’s Chief Financial Officer from November 2013. Marc’s career in pharmaceuticals, which has included periods with Roussel Uclaf, Hoechst Marion Roussel and GSK, has given him extensive industry experience. He is a qualified accountant and joined AstraZeneca in 2013, serving as Executive Vice-President, Global Product and Portfolio Strategy from June to October 2013. Prior to that, he served as Global Head of Rare Diseases at GSK and (concurrently) Chairman, GSK Japan. He holds an MBA from HEC Paris and a Bachelor of Law degree from Paris University.
Marc is a member of the Boards of Orchard Therapeutics Plc and JCR Pharmaceuticals.
David Fredrickson – Executive Vice-President, Oncology Business Unit
Dave was appointed Executive Vice-President, Oncology Business Unit in October 2017 and is responsible for driving growth and maximising the commercial performance of the AstraZeneca global Oncology portfolio. He has global accountability for marketing, sales, medical affairs and market access in Oncology and plays a critical leadership role in setting the Oncology portfolio and product strategy. Previously, Dave served as President of AstraZeneca K.K. in Japan, and Vice-President, Specialty Care in the US. While in Japan, Dave also served as Vice Chairman of the European Federation of Pharmaceutical Industries and Associations Japan and was a Director of the Japan Pharmaceutical Manufacturers Association. Before joining AstraZeneca, Dave worked at Roche/Genentech, where he served in several functions and leadership positions, including Oncology Business Unit Manager in Spain, and strategy, marketing and sales roles in the US. Prior to this, Dave worked at the Monitor Group, LLC (now Monitor Deloitte Group, LLC), a global strategy consultancy. Dave is a graduate of Georgetown University in Washington DC.
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Susan Galbraith - Executive Vice-President, Oncology R&D
Susan was appointed as Executive Vice-President, Oncology R&D in July 2021. In this role, Susan has global accountability for Oncology R&D from discovery through to late-stage development. Since joining AstraZeneca in 2010, Susan has been instrumental in bringing seven new medicines to patients, four of which are now blockbusters. Prior to AstraZeneca, Susan held senior Oncology R&D roles at Bristol-Myers Squibb. A Clinical Oncologist by background, Susan trained in medicine at Manchester and Cambridge Universities and has a PhD from the University of London. She holds an honorary Doctorate of Medical Science from the Institute of Cancer Research and is a Fellow of the Academy of Medical Sciences. Susan serves on the American Association for Cancer Research Board of Directors, the Institute of Cancer Research Scientific Advisory Board and the European Association of Cancer Research Advisory Council.
Menelas (Mene) Pangalos – Executive Vice-President, BioPharmaceuticals R&D (retiring, announced 28 July 2023)
Mene was appointed as Executive Vice-President, BioPharmaceuticals R&D in January 2019. Mene is responsible for discovery through to late-stage development across CVRM, Respiratory & Immunology, Vaccines & Immune Therapies and Neuroscience. Since joining AstraZeneca in 2010, Mene has led the transformation of R&D leading to a greater than fivefold improvement in productivity. Prior to joining AstraZeneca, Mene held senior R&D roles at Pfizer, Wyeth and GSK. Mene holds Honorary Doctorates from Glasgow University and Imperial College, London, is a Fellow of the Royal Society, the Academy of Medical Sciences, the Royal Society of Biology and Clare Hall, University of Cambridge. He is a Visiting Professor at The Wolfson Centre at Kings College and an Honorary Professor at the University of Cambridge. He is also on the Boards of The Francis Crick Institute and The Judge Business School, Cambridge University In 2019, Mene was awarded a knighthood from The Queen and has won a variety of awards including the Prix Galien Medal, Greece. He has overseen the creation of AstraZeneca’s new Global R&D Centre in Cambridge and the company’s COVID-19 efforts.
Jeff Pott – Chief Human Resources Officer, Chief Compliance Officer and General Counsel
Jeff was appointed General Counsel in January 2009 and has overall responsibility for all aspects of AstraZeneca’s Legal and IP function. In addition to his role as General Counsel, he was appointed Chief Human Resources Officer in January 2021 assuming additional responsibilities for the AstraZeneca Human Resources function and was appointed Chief Compliance Officer in January 2023. Jeff joined AstraZeneca in 1995 and has worked in various litigation roles, where he has had responsibility for IP, anti-trust and product liability litigation. Before joining AstraZeneca, he spent five years at the US legal firm Drinker Biddle and Reath LLP, where he specialised in pharmaceutical product liability litigation and anti-trust advice and litigation. He received his Bachelor’s degree in political science from Wheaton College and his Juris Doctor Degree from Villanova University School of Law.
Iskra Reic – Executive Vice-President, Vaccines and Immune Therapies
Iskra was appointed Executive Vice-President (EVP), Vaccines & Immune Therapies, in November 2021, and is responsible for both the early and late-stage development of the Unit’s pipeline and portfolio, medical affairs and commercial operations. Iskra leads the development of the unit’s portfolio and product strategy as well as establishing AstraZeneca as a trusted partner to the Infectious Disease community, supporting our ambition to develop transformative vaccines and antibodies against critical infectious diseases.
Having trained as a Doctor of Dental Surgery at the Medical University of Zagreb, Croatia, Iskra joined AstraZeneca in 2001. During this time, Iskra has held a variety of in-market, regional sales and marketing and general management roles, including Head of Specialty Care, Central & Eastern Europe, Middle East and Africa.
In 2012 she joined AstraZeneca Russia as Marketing Director, before being appointed General Manager in 2014. In 2016 Iskra was made Area Vice-President for Russia and Eurasia, before her appointment as EVP, Europe in April 2017, and the later expansion of this role to Europe & Canada in 2019.
Iskra has an International Executive MBA in Business and Leadership from the IEDC-Bled School of Management, Slovenia.
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Leon Wang – Executive Vice-President, International and China President
Leon Wang is Executive Vice-President, International and President, China. He is responsible for overall strategy driving sustainable growth across the International region, which includes China. Leon joined AstraZeneca China in March 2013 and was promoted to become President, AstraZeneca China in 2014. Under Leon’s leadership, China has become AstraZeneca’s second largest market worldwide and AstraZeneca has become the largest pharmaceutical company in China. In January 2017, Leon was promoted to Executive Vice-President, Asia Pacific Region. Prior to joining AstraZeneca, Leon held positions of increasing responsibility in marketing and business leadership at Roche, where he was a Business Unit Vice-President. In addition, Leon holds several positions in local trade associations and other prominent organisations in China. Leon holds an EMBA from China Europe International Business School, and a Bachelor of Arts from Shanghai International Studies University.
B. Compensation
The information (including graphs and tabular data) set forth under the headings “Corporate Governance—Directors’ Remuneration Report” on pages 102 to 105, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Remuneration” on page 83, “Strategic Report—Our Strategy and Key Performance Indicators—Our Key Performance Indicators and remuneration” on page 12, “Corporate Governance—Remuneration at a glance” on page 106, “Corporate Governance—How our performance measures for 2024 support the delivery of our strategy” on page 107, “Corporate Governance—How the Remuneration Committee ensures targets are stretching” on page 108, “Corporate Governance—Annual Report on Remuneration” on pages 109 to 126, “Corporate Governance—Remuneration Policy” on pages 127 to 138, “Financial Statements—Notes to the Group Financial Statements—Note 22—Post-retirement pension and other defined benefit schemes” on pages 183 to 191, “Financial Statements—Notes to the Group Financial Statements—Note 29—Employee costs and share plans for employees” on pages 201 to 203 and “Financial Statements—Notes to the Group Financial Statements—Note 31—Statutory and other information—Key management personnel compensation”, on page 210, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
C. Board Practices
The information (including graphs and tabular data) set forth under the headings “Corporate Governance—Corporate Governance Overview” on page 77, “Corporate Governance—Board of Directors as at 31 December 2023” on pages 78 to 79, “Corporate Governance—Senior Executive Team (SET) as at 31 December 2023” on page 80, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Board Leadership and Company Purpose” on page 81, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Division of responsibilities” on page 81, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Remuneration” on page 83, “Corporate Governance—Science Committee Report” on page 92, “Corporate Governance—Nomination and Governance Committee Report” on pages 90 to 91, “Corporate Governance—Sustainability Committee Report” on page 93, “Corporate Governance— Compliance with the UK Corporate Governance Code—Risk management and controls—Global Compliance and Group Internal Audit (GIA)” on page 83, “Corporate Governance—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 126, “Corporate Governance—Remuneration at a glance—Looking ahead—Executive Directors’ remuneration for 2024” on page 106, “Corporate Governance—Annual Report on Remuneration—Executive Directors’ remuneration” on pages 109 to 117, “Corporate Governance—Annual Report on Remuneration—Non-Executive Directors’ remuneration” on page 118 and “Corporate Governance—Audit Committee Report” on pages 94 to 101, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
Please also see the information above under the heading Item 6—Directors and Senior Management—Senior Executive Team (SET) Biographies”.
D. Employees
The information set forth under the headings , “Strategic Report—Business Review—Science and Innovation—Research and Development” on pages 34 to 35, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Sales and marketing—Responsible sales and marketing” on page 39, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Operations” on page 40, “Strategic Report—Business Review—Growth and Therapy Area Leadership—IT and IS resources” on page 41, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Business Development” on page 42, “Strategic Report—Business Review—People and Sustainability” on pages 43 to 49 and “Financial Statements—Notes to the Group Financial Statements—Note 29—Employee costs and share plans for employees” (including the tabular data) on pages 201 to 203, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
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E. Share Ownership
The information (including graphs and tabular data) set forth under the headings “Financial Statements—Notes to the Group Financial Statements—Note 29—Employee costs and share plans for employees” on pages 201 to 203, “Corporate Governance—Annual Report on Remuneration—Directors’ shareholdings” on pages 119 to 120, and “Additional Information—Directors’ Report—Directors’, officers’ and SET shareholdings” and “—Options to purchase securities from registrant or subsidiaries” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
F. Disclosure of a registrant’s action to recover erroneously awarded compensation
Not applicable.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
The information set forth under the heading “Additional Information—Shareholder information—US holdings” on page 226 and “Additional Information—Directors’ Report—Major shareholdings” (including tabular data) on page 228 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
B. Related Party Transactions
The information set forth under the headings “Financial Statements—Notes to the Group Financial Statements—Note 31—Statutory and other information—Related party transactions” on page 210, “Additional Information—Shareholder information—Related party transactions” on page 225, “Additional Information—Shareholder information—Issued share capital, shareholdings and share prices” on page 226 and “Additional Information—Directors’ Report—Major shareholdings” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
C. Interests of Experts and Counsel
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial Information
Please see the information below under the heading Item 18—“Financial Statements.” The information (including graphs and tabular data) set forth under the headings “Additional Information—Shareholder information” on pages 225 to 226, “Strategic Report —Financial Review—Dividend and share repurchases” on page 71 and “Additional Information—Directors’ Report—Distributions to shareholders-dividends for 2023” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
Summarized financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC (“AstraZeneca Finance”) is the issuer of 0.700% Notes due 2024, 1.200% Notes due 2026, 1.750% Notes due 2028, 4.875% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes due 2031 and 4.875% Notes due 2033 (the “AstraZeneca Finance Notes”). Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees by AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally with all of AstraZeneca Finance’s existing and future senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC’s existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
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AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether by dividends, distributions, loans or otherwise.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X of the Securities Act, we present below the summary financial information for AstraZeneca PLC, as Guarantor, excluding its consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding its consolidated subsidiaries. The following summary financial information of AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and transactions between the combining entities have been eliminated. Financial information for non-guarantor entities has been excluded. Intercompany balances and transactions between the obligor group and the non-obligor subsidiaries are presented on separate lines.
Obligor group summarised Statement of Comprehensive Income
|
|
FY 2023 |
|
FY 2022 |
|
|
$m |
|
$m |
Total Revenue |
|
— |
|
— |
Gross profit |
|
— |
|
— |
Operating loss |
|
(34) |
|
(27) |
Loss for the period |
|
(976) |
|
(687) |
Transactions with subsidiaries that are not issuers or guarantors |
|
15,660 |
|
1,071 |
Obligor group summarised Statement of Financial Position information
|
|
At 31 Dec 2023 |
|
At 31 Dec 2022 |
|
|
$m |
|
$m |
Current assets |
|
5 |
|
4 |
Non-current assets |
|
— |
|
— |
Current liabilities |
|
(4,856) |
|
(2,839) |
Non-current liabilities |
|
(22,239) |
|
(22,797) |
Amounts due from subsidiaries that are not issuers or guarantors |
|
18,421 |
|
7,806 |
Amounts due to subsidiaries that are not issuers or guarantors |
|
— |
|
(293) |
Developments in Legal Proceedings
For information in respect of material legal proceedings in which AstraZeneca is currently involved, including those discussed below, please see the information (including tabular data) set forth under the heading “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 and is incorporated by reference.
The proceedings discussed below are provided to supplement and update the corresponding disclosure in AstraZeneca’s “Annual Report and Form 20-F Information 2023”. Unless noted below or in AstraZeneca’s “Annual Report and Form 20-F Information 2023”, no provisions have been established in respect of these proceedings.
UK proceedings
PARP Inhibitor Royalty Dispute
In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK)) entered into two worldwide, royalty-bearing patent license agreements with AstraZeneca related to GSK’s product niraparib. In May 2021, AstraZeneca filed a lawsuit against GSK in the Commercial Court of England and Wales alleging that GSK has failed to pay all of the royalties due on niraparib sales under the license agreements. The case was transferred to the Chancery Division and a trial took place in March 2023. In April 2023, the trial court issued a decision in AstraZeneca’s favour. GSK was granted permission to appeal, and the appellate hearing was held in January 2024. In February 2024, the Court of Appeal issued a decision in GSK’s favour. AstraZeneca is considering its options.
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US Proceedings
Onglyza and Kombiglyze
In the US, AstraZeneca has been defending various lawsuits alleging heart failure, cardiac injuries, and/or death from treatment with Onglyza or Kombiglyze. In the California state court proceeding, the trial court granted summary judgment for AstraZeneca, which the California appellate court affirmed. The California Supreme Court has declined further review, so the California state court proceeding has concluded. In 2022, the US District Court for the Eastern District of Kentucky, presiding over the consolidated federal cases, granted AstraZeneca’s motion for summary judgment. In February 2024, the US Court of Appeals for the Sixth Circuit affirmed the grant of summary judgment in the consolidated federal cases.
B. Significant Changes
Please see the information set forth under the heading “Financial Statements—Notes to the Group Financial Statements—Note 32—Subsequent events” on page 210 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 and is incorporated by reference.
The discussion below is provided to supplement and update the corresponding disclosure in AstraZeneca’s “Annual Report and Form 20-F Information 2023”.
Icosavax acquisition
In December 2023, AstraZeneca entered into a definitive agreement to acquire Icosavax, Inc. The acquisition strengthens AstraZeneca’s late-stage pipeline with Icosavax’s lead investigational vaccine candidate, IVX-A12, a potential first-in-class, Phase III-ready, combination VLP vaccine that targets both RSV and human metapneumovirus (hMPV). RSV and hMPV are both leading causes of severe respiratory infection and hospitalisation in adults 60 years of age and older and those with chronic conditions such as cardiovascular, renal and respiratory disease. Subject to the satisfaction of the conditions in the merger agreement, the acquisition closed on February 19, 2024.
Other than as disclosed in this Item, since the date of the annual consolidated financial statements included in this Form 20-F dated February 20, 2024, no significant change has occurred.
ITEM 9. THE OFFER AND LISTING
A. Offer and Listing Details
The information (including tabular data) set forth under the heading “Additional Information—Shareholder information” on pages 225 to 226 and “Additional Information—Shareholder information—Ordinary Shares in issue” on page 226 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
The corresponding trading symbol is “AZN” in each of AstraZeneca’s principal markets for trading in AstraZeneca shares.
B. Plan of Distribution
Not applicable.
C. Markets
The information set forth in the introductory paragraph under the heading “Additional Information— Shareholder information” on page 225 and “Additional Information—Shareholder information—Issued share capital, shareholdings and share prices” on page 226 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
D. Selling Shareholders
Not applicable.
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E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
The information set forth under the heading “Additional Information—Directors’ Report—Articles of Association” on page 228 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. Please also see the information above in the first paragraph under the heading Item 4—“Information on the Company—History and Development of the Company”.
C. Material Contracts
Not applicable.
D. Exchange Controls
The information set forth under the headings “Additional Information—Shareholder information—Exchange controls and other limitations affecting security holders” on page 226 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
E. Taxation
Taxation for US persons
The following statements are intended only as a general guide to certain material UK and US federal income tax consequences of ownership of Ordinary Shares or ADRs held as capital assets by the US holders described below. This summary is based on current UK and US federal income tax law, the current US/UK double taxation convention and what is understood to be the current practice of HMRC and the US Internal Revenue Service as at the date of this Form 20-F dated February 20, 2024, each of which may change, possibly with retroactive effect. This summary does not describe all of the tax consequences that may be relevant in light of the US holders’ particular circumstances (including the US Medicare contribution tax or the US alternative minimum tax) and tax consequences applicable to US holders subject to special rules. US holders and any holders who may be subject to tax in the US or the UK are urged to consult their tax advisers regarding the UK and US federal income tax consequences of the ownership and disposition of Ordinary Shares or ADRs in their particular circumstances.
This summary is based in part on representations of the depositary for ADRs and assumes that each obligation in the deposit agreement among the Company and the depositary and the holders from time to time of ADRs and any related agreements will be performed in accordance with its terms. For the purposes of this summary, the term ‘US holder’ means a beneficial owner of Ordinary Shares or ADRs that is, for US federal income tax purposes, an individual, a corporation or an estate or trust that, in each case, is treated as a US person.
For US federal income tax purposes, a holder of ADRs generally will be treated as the owner of the underlying Ordinary Shares. Accordingly, deposits or withdrawals of Ordinary Shares for ADRs will not be subject to US federal income tax.
UK and US income taxation of dividends
The Company is not required to withhold UK tax when paying a dividend. Liability to tax on receipt of dividends will depend upon the individual circumstances of a US holder. A US holder that is resident outside the UK for UK tax purposes will not generally be subject to UK tax on dividend income received, but should consult their own tax adviser.
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For US federal income tax purposes, distributions paid by the Company to a US holder are generally included in gross income as foreign source ordinary dividend income when actually or constructively received. For any dividend paid in a foreign currency, the amount of the dividend will, in the case of ADRs, be the US dollar value of the foreign currency payment received by the depositary determined at the spot rate of the relevant foreign currency on the date the dividend is received by the depositary (or, in the case of Ordinary Shares, the US dollar value of the foreign currency payment received by the US holders, determined at the spot rate of the relevant foreign currency on the date the dividend is received by the US holders, regardless of whether the dividend is converted into US dollars). Dividends will not be eligible for the dividends received deduction generally available to US corporations.
If the dividend is converted into US dollars on the date of receipt, US holders of Ordinary Shares generally should not be required to recognise foreign currency gains or losses in respect of the dividend income. They may have foreign currency gain or loss (which would be US source and taxable at the rates applicable to ordinary income) if the amount of such dividend is converted into US dollars after the date of its receipt.
Subject to applicable limitations, dividends received by certain non-corporate US holders of Ordinary Shares or ADRs may be taxable at favourable US federal income tax rates. US holders should consult their own tax advisers to determine whether they are subject to any special rules which may limit their ability to be taxed at these favourable rates.
Taxation on capital gains
US holders that are individuals or companies who are not resident in the UK for tax purposes are generally not liable for UK tax on capital gains made on the disposal of their Ordinary Shares or ADRs, unless such Ordinary Shares or ADRs are used, held or acquired in connection with a trade, profession or vocation carried on in the UK through a branch or agency or other permanent establishment. US holders should consult their own tax advisers about the treatment of capital gains in the UK.
For US federal income tax purposes, a US holder will generally recognise US source capital gain or loss on the sale or exchange of Ordinary Shares or ADRs in an amount equal to the difference between the US dollar amount realised and such holder’s US dollar tax basis in the Ordinary Shares or ADRs. US holders should consult their own tax advisers about the treatment of capital gains, which may be taxed at lower rates than ordinary income for non-corporate US holders, and capital losses, the deductibility of which may be subject to limitations.
Passive Foreign Investment Company (PFIC) rules
We believe that we were not a PFIC for US federal income tax purposes for the year ended 31 December 2023. However, since PFIC status depends on the composition of our income and assets, and the market value of our assets, from time to time, there can be no assurance that we will not be considered a PFIC for any taxable year. If we were treated as a PFIC, certain adverse tax consequences could apply to US holders.
Information reporting and backup withholding
Payments of dividends and sales proceeds that are made within the US or through certain US-related financial intermediaries may be subject to information reporting and backup withholding, unless the US holder is an exempt recipient or, in the case of backup withholding, the US holder provides its taxpayer identification number and certifies that it is not subject to backup withholding. The amount of any backup withholding from a payment to a US holder will be allowed as a credit against the holder’s US federal income tax liability and may entitle the holder to a refund, provided that the required information is timely supplied to the US Internal Revenue Service.
Certain US holders who are individuals (or certain specified entities) may be required to report information relating to securities issued by non-US persons (or foreign accounts through which the securities are held), subject to certain exceptions (including an exception for securities held in accounts maintained by US financial institutions). US holders should consult their tax advisers regarding their reporting obligations.
UK inheritance tax
Ordinary Shares or ADRs held by an individual who is domiciled in the US for the purposes of the United States – United Kingdom Double Taxation Convention relating to taxes on estates of deceased persons and on gifts (the Estate Tax Convention), and who is not for such purposes a national of the UK, will generally not be subject to UK inheritance tax on the individual’s death or on a lifetime transfer of the Ordinary Shares or ADRs, provided that any applicable US federal gift or estate tax liability is paid, except in certain cases where the Ordinary Shares or ADRs: (i) are comprised in a settlement (unless, at the time of the settlement, the settlor was domiciled in the US and not a national of the UK); (ii) are part of the business property of a UK permanent establishment of an enterprise; or (iii) pertain to a UK fixed base of an individual used for the performance of independent personal services.
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In the exceptional case where the Ordinary Shares or ADRs are subject to both UK inheritance tax and US federal gift or estate tax, the Estate Tax Convention generally provides for double taxation to be relieved by means of credit relief.
UK stamp duty reserve tax and stamp duty
Under current UK law a charge to UK stamp duty or UK stamp duty reserve tax (SDRT) may arise on the deposit of Ordinary Shares in connection with the creation of ADRs. Under these rules, the rate of UK stamp duty or SDRT is 1.5% applied, in each case, to the issue price when the Ordinary Shares are issued, the amount or value of the consideration or, in some circumstances, the value of the Ordinary Shares. Following certain EU litigation, HMRC accepted that they would no longer seek to apply the 1.5% charge to the issue (or, where it is integral to the raising of new capital, the transfer) of shares (such as the Ordinary Shares) into a depositary receipt system (such as the ADR arrangement). UK legislation enacted on 29 June 2023, in the form of the Retained EU Law (Revocation and Reform) Act 2023, created some uncertainty as to the status of the 1.5% charge from 1 January 2024. The Finance Bill 2023-4, which is expected to be enacted in early 2024, makes provision to ensure it continues to be the case, notwithstanding the effect of the Retained EU Law (Revocation and Reform) Act 2023, that UK stamp duty or SDRT of 1.5% is not payable in relation to issues of securities into depositary receipt systems, and transfers of securities into a depositary receipt system, where such transfer is integral to the raising of new capital by the company concerned. These measures will have provisional effect from 1 January 2024. The Finance Bill 2023-4, if enacted, will give permanent legislative effect to the proposed measures, which will otherwise cease to have effect. Therefore, there is some remaining uncertainty as to the status of the 1.5% charge in the period between 1 January 2024 and enactment of the Finance Bill 2023-4.
Transfers of Ordinary Shares into CREST will generally not be subject to UK stamp duty or SDRT, unless such a transfer is made (or deemed to be made) for a consideration in money or money’s worth, in which case a liability to SDRT will arise, usually at the rate of 0.5% of the value of the consideration.
A transfer of, or an unconditional agreement to transfer, Ordinary Shares (whether within or outside CREST) will generally be subject to UK stamp duty and/or SDRT at 0.5% of the amount or value of any consideration (in the case of stamp duty, this will be rounded up to the nearest £5). Where both UK stamp duty and SDRT apply, then any SDRT charge may be cancelled if within six years of the date of the agreement becoming unconditional an instrument of transfer is executed pursuant to the agreement, and stamp duty is paid on that instrument. The purchaser would usually pay any UK stamp duty or SDRT that is due. No UK stamp duty will be payable on the transfer of existing ADRs, provided that there is no written instrument of transfer, and no SDRT should be payable on an unconditional agreement to transfer existing ADRs.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
The Company’s Articles of Association and other documents concerning the Company which are referred to in this Form 20-F dated February 20, 2024, may be inspected at the Company’s registered office at 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, UK.
I. Subsidiary Information
Not applicable.
J. Annual Report to Security Holders
The Company intends to submit any annual report provided to security holders in electronic format as an exhibit to a current report on Form 6-K.
47
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Financial Review—Financial risk management” on page 71 and “Financial Statements—Notes to the Group Financial Statements—Note 28—Financial risk management objectives and policies” on pages 195 to 201, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
48
D. American Depositary Shares
Fees and Charges Payable by ADR Holders
The Company’s American Depositary Receipt (“ADR”) program is administered by Deutsche Bank Trust Company Americas (“DBTCA” or the “Depositary”), as the depositary. The holder of an ADR may have to pay the following fees and charges to DBTCA in connection with ownership of the ADR:
Category |
|
Depositary actions |
|
Associated fee or charge |
(a) Depositing or substituting the underlying shares |
|
Issuances upon deposits of shares (excluding issuances as a result of stock distributions or the exercise of rights) |
|
Up to $5.00 for each 100 ADSs (or fraction thereof) issued |
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|
|
|
|
(b) Receiving or distributing dividends (1) |
|
Distributions of stock dividends or other free stock distributions, cash dividends or other cash distributions (i.e., sale of rights and other entitlements), distributions of securities other than ADSs or rights to purchase additional ADSs |
|
Up to $5.00 for each 100 ADSs (or fraction thereof) |
|
|
|
|
|
(c) Selling or exercising rights |
|
The exercise of rights to purchase additional ADSs |
|
Up to $5.00 for each 100 ADSs (or fraction thereof) |
|
|
|
|
|
(d) Withdrawing, cancelling or reducing an underlying security |
|
Surrendering ADSs for cancellation and withdrawal of deposited property |
|
Up to $5.00 for each 100 ADSs (or portion thereof) surrendered or cancelled (as the case may be) |
|
|
|
|
|
(e) Transferring, combination or split-up of receipts |
|
|
|
Not applicable. |
|
|
|
|
|
(f) General depositary services, particularly those charged on an annual basis (1) |
|
Depositary services fee |
|
A fee not in excess of $5.00 per 100 ADSs (or fraction thereof) held on the applicable record date(s) established by the Depositary. |
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|
|
|
|
(g) Fees and expenses of the depositary |
|
Fees and expenses incurred by the Depositary or the Depositary’s agents on behalf of holders, including in connection with: ●
taxes (including applicable interest and penalties) and other governmental charges
●
registration of shares or other deposited securities on the share register and applicable to transfers of shares or other deposited securities to or from the name of the custodian, the Depositary or any nominees upon the making of deposits and withdrawals, respectively;
●
cable, telex and facsimile transmission and delivery expenses
●
expenses and charges incurred by the Depositary in conversion of foreign currency into US dollars
●
compliance with exchange control regulations and other regulatory requirements applicable to the shares, deposited securities, ADSs and ADRs
●
the fees and expenses incurred by the Depositary, the custodian, or any nominee in connection with the delivery or servicing of deposited property (as defined in the Deposit Agreement)
|
|
As incurred by the Depositary. |
| (1) | $0.03 per ADR annually |
Fees and Payments Made by DBTCA to Us
Pursuant to the deposit agreement, the Depositary may charge a fee up to $0.05 per ADR in respect of dividends paid by us. For the year ended December 31, 2023, we agreed that the Depositary could charge an annual fee of $0.03 per ADR in respect of dividends paid by us. As at December 31, 2023, we have been paid approximately $17.05 million arising out of fees charged in respect of dividends paid during 2023 and $0.87 million as a (further) contribution to the Company’s ADR program costs. We also have an agreement with the Depositary that it will waive a certain amount of its fees for standard costs associated with the administration of the ADR program up to $10,000 per year.
49
PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
Not applicable.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.
ITEM 15. CONTROLS AND PROCEDURES
A. Disclosure Controls and Procedures
The information set forth under the heading “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Risk Management and Controls” on page 83, “Corporate Governance—Audit Committee Report—Internal Controls” on page 100, and “Financial Statements—Directors’ Annual Report on Internal Controls over Financial Reporting” on page 140, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
US corporate governance requirements
The Company’s ADRs are traded on the Nasdaq and, accordingly, it is subject to the reporting and other requirements of the SEC applicable to foreign private issuers. Section 404 of the Sarbanes-Oxley Act requires companies to include in their annual report on Form 20-F filed with the SEC, a report by management stating its responsibility for establishing internal control over financial reporting and to assess annually the effectiveness of such internal control. The Company has complied with those provisions of the Sarbanes-Oxley Act applicable to foreign private issuers.
B. Management’s Annual Report on Internal Control over Financial Reporting
As required by US regulations, management is responsible for establishing and maintaining adequate internal control over financial reporting for the Company, and is required to identify the framework used to evaluate the effectiveness of the Company’s internal control over financial reporting and to assess the effectiveness of such internal control. In this regard, management has made the same assessment and reached the same conclusion as that set forth in the section entitled “Financial Statements—Directors’ Annual Report on Internal Controls over Financial Reporting” on page 140 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024, which is incorporated by reference.
C. Attestation Report of Independent Registered Public Accounting Firm
The effectiveness of the Company’s internal control over financial reporting as of December 31, 2023, has been audited by PricewaterhouseCoopers LLP, independent registered public accounting firm, as stated in its report dated February 8, 2024, which is included below under the heading Item 18—“Financial Statements—Report of Independent Registered Public Accounting Firm”.
D. Changes in Internal Control over Financial Reporting
Based on the evaluation conducted, management has concluded that no such changes have occurred during the period covered by this Form 20-F that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
ITEM 16. RESERVED
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
The information set forth under the heading “Corporate Governance—Corporate Governance Overview—Board Committee membership and meeting attendance in 2023” on page 77 and “Corporate Governance—Audit Committee Report—Committee overview—Committee composition” on page 95, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
50
ITEM 16B. CODE OF ETHICS
The information set forth under the headings “Strategic Report—Business Review—People and Sustainability—Code of Ethics” on page 49, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Risk Management and Controls—Global Compliance and Group Internal Audit (GIA)” on page 83, “Business Review—Science and Innovation—Bioethics” on page 36, and “Corporate Governance—Audit Committee Report—Legal and Compliance” on page 96, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. AstraZeneca’s Code of Ethics is available within the ‘Ethics and transparency’ section of our website at www.astrazeneca.com/sustainability/ethics-and-transparency.html.
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table sets forth the aggregate fees for professional services rendered by PricewaterhouseCoopers LLP (PCAOB ID 876) in 2023 and 2022:
|
|
Year ended December 31, |
||
|
|
2023 |
|
2022 |
|
|
($ million) |
||
Audit fees |
|
29.1 |
|
28.7 |
Audit-related fees |
|
0.8 |
|
0.4 |
All other fees |
|
0.2 |
|
0.2 |
Total |
|
30.1 |
|
29.3 |
Audit fees included $15.0 million for the audit of subsidiaries pursuant to legislation (2022: $15.1 million), $10.2 million for the Group audit (2022: $9.9 million), $0.6 million for assurance services in relation to interim financial statements (2022: $0.6 million) and $3.3 million in respect of section 404 of the Sarbanes-Oxley Act (2022: $3.1 million). $0.7 million of Audit fees payable in 2023 are in respect of the Group audit and audit of subsidiaries related to prior years ($0.6 million of Audit fees payable in 2022 are in respect of the Group audit and audit of subsidiaries related to prior years).
Audit-related fees included $0.5 million of other audit-related services (2022: $0.1 million) and $0.3 million for the audit of subsidiaries’ pension schemes (2022: $0.3 million). Included in Audit-related fees for 2023 are $0.3 million of services provided in relation to the 2023 debt issuance and EMTN programme renewal.
All other fees of $0.2 million relate to other assurance services (2022: $0.2 million).
The information (including tabular data) set forth under the heading “Corporate Governance—Audit Committee Report” on pages 94 to 101 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
US law and regulations permit the Audit Committee pre-approval requirement to be waived with respect to engagements for non-audit services aggregating to no more than five percent of the total amount of fees paid by AstraZeneca to its principal accountants, if such engagements were not recognized by AstraZeneca at the time of engagement and were promptly brought to the attention of the Audit Committee or a designated member thereof and approved prior to the completion of the audit. In 2023 and 2022, the percentage of the total amount of fees paid by AstraZeneca to its principal accountant for non-audit services in each category that was subject to such a waiver was less than five per cent for each year.
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
Not applicable.
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not applicable.
51
ITEM 16G. CORPORATE GOVERNANCE
The Company is a public limited company incorporated in England and Wales, admitted to the premium segment of the Official List of the Financial Conduct Authority (“FCA”) and to trading on the main market of the London Stock Exchange. As a result, it follows the U.K. Corporate Governance Code 2018 (the “U.K. Code”) in respect of its corporate governance practices. The current edition of the U.K. Code, which came into effect for reporting periods beginning on or after January 1, 2019, was effective to the Company for the year ended December 31, 2023. The Companies Act 2006 (the “U.K. Act”) and the Listing Rules of the U.K. Financial Conduct Authority (the “FCA Rules”) imposes certain requirements that also influence the Company’s corporate governance practices. The Company has ADRs listed on the Nasdaq Stock Exchange and, under the Nasdaq Listing Rules applicable to listed companies, as a foreign private issuer, the Company is permitted to follow the corporate governance practice of its home country in lieu of certain provisions of the Nasdaq Listing Rules.
The Company is required to disclose any significant ways in which its corporate governance practices differ from those followed by US companies under the Nasdaq Corporate Governance Requirements. In addition, the Company must comply fully with the provisions of the Nasdaq Corporate Governance Requirements relating to the composition, responsibilities and operation of audit committees, applicable to foreign private issuers. These provisions incorporate the rules concerning audit committees implemented by the SEC under the Sarbanes-Oxley Act. The Company has reviewed the corporate governance practices required to be followed by US companies under the Nasdaq Corporate Governance Requirements and its corporate governance practices are generally consistent with those standards.
52
A summary of the significant ways in which the Company’s corporate governance practices differ from those followed by US domestic companies under the Nasdaq Standards is set forth below.
Nasdaq Listing Rules |
|
AstraZeneca Corporate Governance Practice |
1. Under the Nasdaq Listing Rules, the audit committee is to be directly responsible for the appointment, compensation, retention and oversight of a listed company’s external auditor. |
|
Under the U.K. Act, a company’s external auditors are appointed by its shareholders, or in limited circumstances, by the directors of the company or the Secretary of State. Under the U.K. Code, a company’s audit committee is responsible for, amongst other things: conducting the tender process and making recommendations to the board, about the appointment, reappointment and removal of the external auditor, and approving the remuneration and terms of engagement of the external auditor; reviewing and monitoring the external auditor’s independence and objectivity; reviewing the effectiveness of the external audit process, taking into consideration relevant U.K. professional and regulatory requirements; and developing and implementing policy on the engagement of the external auditor to supply non-audit services. In the event that the board does not accept the audit committee’s recommendation on the external auditor appointment, reappointment or removal, a statement from the audit committee explaining its recommendation and the reasons why the board has taken a different position should be included in the company’s annual report. This should also be included in any papers recommending appointment or reappointment. |
|
|
|
2. Under the Nasdaq Listing Rules, each listed company must have a formal written compensation committee charter that specifies (A) the compensation committee’s responsibility for determining, or recommending to the board for determination, the compensation of the chief executive officer and all other Executive Officers of the company, and (B) that the chief executive officer may not be present during voting or deliberations on his or her compensation. |
|
Under the U.K. Code, the Company’s Remuneration Committee determines the Company’s global remuneration frameworks and principles, approves individual salary decisions and related matters for executive members of the Company’s Board of Directors, the Senior Executive Team and the Company Secretary, and reviews annual bonus payments for all executives reporting directly to the Senior Executive Team members. While the Remuneration Committee does not make initial recommendations to the Board of Directors in this respect, it does report to the Board of Directors on these matters. Under the U.K. Act, the Company is required to offer shareholders: (i) a binding vote on the Company’s forward looking remuneration policy for its directors at least every three years; and (ii) a separate annual advisory vote on the implementation of the Company’s existing remuneration policy in terms of the payments and share awards made to its directors during the year, which is disclosed in an annual remuneration report. The U.K. Code does not require that the terms of reference of the Company’s Remuneration Committee specify that the chief executive officer may not be present during voting or deliberations on his or her compensation. |
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|
|
3. Under the Nasdaq Listing Rules, each listed company must have a compensation committee comprised of at least two members each of whom must be an Independent Director, as defined under Listing Rule 5605(a)(2). |
|
Under the U.K. Code, all of the members of the Company’s Remuneration Committee should be independent non-executive directors, with a minimum membership of three. Under the U.K. Code, the chair of the Company may be a member, but not chair, of the Remuneration Committee, provided he or she was considered independent on appointment as chair. In addition, the chair of a company’s remuneration committee should have served for at least 12 months on a remuneration committee before his or her appointment. |
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4. Under the Nasdaq Listing Rules, director nominees must either be selected, or recommended for the Board’s selection, either by (A) Independent Directors constituting a majority of the Board’s Independent Directors in a vote in which only Independent Directors participate, or (B) a nominations committee comprised solely of Independent Directors. |
|
Under the U.K. Code, a majority of the members of the Company’s nomination committee should be independent non-executive directors. Under the U.K. Code, the chair of the Company may be a member or chair of the nomination committee, provided he or she was considered independent on appointment as chair. However, the chair of the board may not chair the nomination committee when it is dealing with the appointment of his or her successor. |
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|
|
5. Under the Nasdaq Listing Rules, the by-laws of a listed company, other than a limited partnership, must provide for a quorum requirement for shareholder meetings of not less than 331/3% of the outstanding shares of voting common stock. |
|
Under the U.K. Act, if a company’s articles of association do not provide otherwise, two qualifying persons must be present at a meeting for a valid quorum, unless they are both representatives of the same corporation or have been appointed as proxies by the same shareholder. The Company’s Articles of Association contain a similar requirement. |
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6. Under the Nasdaq Listing Rules, subject to certain exceptions, shareholder approval is required prior to the issuance of securities when a stock option or purchase plan is to be established or materially amended or other equity compensation arrangement made or materially amended, pursuant to which stock may be acquired by officers, directors, employees, or consultants. |
|
Under the FCA Rules, shareholder approval is required to be obtained by the Company for the adoption of equity compensation plans which are either long-term incentive schemes in which directors of the Company can participate or schemes which may involve the issue of new shares. Under the FCA Rules, these plans may not be changed to the benefit of the plan participants unless shareholder approval is obtained (with certain minor exceptions, for example, to benefit the administration of the plan or to take account of tax benefits). |
53
Board Diversity Matrix (as of December 31, 2023)
Country of Principal Executive Offices: |
|
England and Wales |
Foreign Private Issuer |
|
Yes |
Disclosure Prohibited Under Home Country Law |
|
No |
Total Number of Directors |
|
13 |
|
|
Female |
|
Male |
|
Non-Binary |
|
Did Not Disclose Gender |
Part I: Gender Identity |
|
|
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|
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Directors |
|
6 |
|
7 |
|
- |
|
- |
Part II: Demographic Background |
|
|
||||||
Underrepresented Individual in Home Country Jurisdiction |
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2 |
||||||
LGBTQ+ |
|
- |
||||||
Did Not Disclose Demographic Background |
|
1 |
||||||
ITEM 16H. MINE SAFETY DISCLOSURE
Not applicable.
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
ITEM 16J. INSIDER TRADING POLICIES
Not applicable.
ITEM 16K. CYBERSECURITY
Risk and Management Strategy
AstraZeneca employs complimentary processes for assessing, identifying, and managing risk from cybersecurity threats. AstraZeneca information systems are protected by a multi-layered set of technology, processes, and cybersecurity experts consistent with the US National Institute of Standards and Technology (NIST) Cybersecurity Framework (CSF). Maturity against the one hundred and eighteen NIST CSF controls is assessed via recurring independent third-party assessments, internal audits, and penetration testing. The outputs of these activities are represented in detailed cybersecurity operations and performance metrics that are reviewed by multiple leadership levels and are summarized in enterprise risk reporting provided to the Senior Executive Committee and Audit Committee. Third-party partners are subject to appropriate NIST CSF controls as specified in AstraZeneca third-party risk management and procurement processes, and enforced via service agreement and contract terms and conditions. AstraZeneca has not experienced any previous cybersecurity incidents that have materially impacted its business or business strategy. Ongoing risks from cybersecurity threats demand management vigilance, investment, and oversight, as further described below.
54
Governance
Cybersecurity remains a core AstraZeneca enterprise risk focus area. The Board of Directors’ Audit Committee provides oversight of risks from cybersecurity threats. The Senior Executive Team (SET) receives quarterly cybersecurity updates via the enterprise risk function. The quarterly updates are forwarded to the Audit Committee. Audit Committee expertise includes leaders that have management expertise across a broad range of industries and market sectors which includes oversight of cybersecurity risk and incidents. The AstraZeneca cybersecurity risk management program is implemented by the Chief Information Security Officer (CISO), who reports to the Chief Digital Officer/Chief Information Officer (CDIO). The CISO is the primary executive responsible for assessing and managing cybersecurity risks, including delivering recurring updates to CDIO and SET via standardized quarterly reporting. The CISO has over three decades of cumulative cybersecurity expertise gained from increasingly complex roles in Life Sciences, Electronics Manufacturing, Supply Chain, Software Development, and IT Technical Support. The CDIO reviews risk management recommendations from the CISO and tracks AstraZeneca’s global internal audit management plans that include corrective actions to address exposed risk to information systems from cybersecurity threats. AstraZeneca maintains a global cybersecurity defense operations center that relies on advanced technology, skilled cybersecurity operations staff and documented incident response plans that are closely coupled with AstraZeneca’s enterprise crisis management processes. Incident response plans and escalation via decision matrix criteria defined in crisis management procedures ensure management is informed of cybersecurity incident prevention, detection, mitigation, and remediation. The CDIO and CISO report risk information to the Audit Committee via recurring Board of Directors presentations and written reports.
The information set forth under the heading “Strategic Report—Business Review—IT and IS resources” on page 41, “Strategic Report—Risk Overview—Principal Risks—Cybersecurity Risk” on page 54, “Strategic Report—Risk Overview—Supply chain and business execution risks—Failure in information technology or cybersecurity” on page 56, and “Corporate Governance—Audit Committee Report—Cyber risk, digital security and information governance” on page 96, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. Please also see the information above under the heading Item 3—“Key Information—Risk Factors—Supply chain and business execution risks—Failure in information technology or cybersecurity” above.
55
PART III
ITEM 17. FINANCIAL STATEMENTS
The Company has responded to Item 18 in lieu of this item.
ITEM 18. FINANCIAL STATEMENTS
The accompanying Consolidated Statements of Comprehensive Income, of Financial Position, of Changes in Equity and of Cash Flows and the Group Accounting Policies and the related notes (including tabular data) set forth under the headings “Financial Statements” on pages 139 to 210 (excluding the information set forth under the subheadings “Independent auditors’ report to the members of AstraZeneca PLC” on pages 141 to 147) and “Financial Statements—Group Financial Record” on page 223, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
In accordance with Rule 405(a)(3) under Regulation S-T, this information (including tabular data) is reproduced under Item 8 herein tagged with Inline XBRL formatting.
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of AstraZeneca PLC
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated statements of financial position of AstraZeneca PLC and its subsidiaries (the “Group”) as of 31 December 2023, 2022 and 2021, and the related consolidated statements of comprehensive income, of changes in equity and of cash flows for each of the three years in the period ended 31 December 2023, including the Group accounting policies and the related notes to the Group financial statements (collectively referred to as the “consolidated financial statements”). We also have audited the Group’s internal control over financial reporting as of 31 December 2023, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Group as of 31 December 2023, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended 31 December 2023 in accordance with (i) IFRS Accounting Standards as issued by the International Accounting Standards Board, (ii) UK-adopted International Accounting Standards and (iii) International Accounting Standards as adopted by the European Union. Also in our opinion, the Group maintained, in all material respects, effective internal control over financial reporting as of 31 December 2023, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
Basis for Opinions
The Group’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Annual Report on Internal Control over Financial Reporting appearing under Item 15.B. Our responsibility is to express opinions on the Group’s consolidated financial statements and on the Group’s internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Group in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
56
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorisations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorised acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgements. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Recognition and measurement of accruals for Managed Care, Medicaid and Medicare Part D rebates on US Product Sales (excluding Rare Diseases)
As described in the Group Accounting Policies, and Notes 1 and 20 to the consolidated financial statements, when invoicing Product Sales in the US, management estimates the rebates the Group expects to pay and considers there to be a significant estimate associated with the rebates for Managed Care, Medicaid and Medicare Part D. The major market with rebates and other revenue accruals is the US. The US Rebates, chargebacks, returns and other revenue accruals liability at 31 December 2023 amounted to $5,116 million (including $190 million attributed to Rare Diseases), principally consisting of rebates related to Managed Care, Medicaid and Medicare Part D. Rebates are amounts payable or credited to a customer, usually based on the quantity or value of Product Sales to the customer for specific products in a certain period. At the time Product Sales are invoiced, rebates and deductions that the Group expects to pay are estimated. These rebates typically arise from sales contracts with government payers, third-party managed care organisations and various state programmes. The methodology and assumptions used to estimate rebates and returns are monitored and adjusted regularly in the light of contractual and legal obligations, historical trends, past experience and projected market conditions. The rebate estimates include assumptions in respect of aggregate future sales levels, segment mix and customers’ contractual performance, and in addition for Managed Care, US Medicaid and Medicare Part D, the channel inventory levels, and assumptions related to lag time.
57
The principal considerations for our determination that performing procedures relating to recognition and measurement of accruals for Managed Care, Medicaid and Medicare Part D rebates on US Product Sales (excluding Rare Diseases) is a critical audit matter are the (i) significant estimation by management in determining the accruals for the Managed Care, Medicaid, and Medicare Part D programmes, which are monitored and adjusted in light of contractual and legal obligations, historical trends, past experience and projected market conditions and (ii) high degree of auditor judgement, subjectivity, and effort in evaluating management’s significant assumptions related to aggregate future sales levels, segment mix and customers’ contractual performance, the channel inventory levels, and lag time. In addition, the audit effort involved the use of professionals with specialised skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s recognition and measurement of the Managed Care, Medicaid, and Medicare Part D rebate accruals. These procedures also included, among others, (i) developing an independent estimate of these accruals; (ii) comparing our independent estimate to the accruals recorded by management; (iii) assessing the effect of any adjustments to prior years’ accruals in the current year’s results; and (iv) testing actual payments made and rebate claims processed by the Group, and evaluating those claims for consistency with the contractual and mandated terms of the Group’s arrangements. Developing the independent estimate of the accruals involved assessing the terms of the specific rebate programmes and/or contracts with customers; historical revenue data; market demand and market conditions in the US; third party information on inventory held by direct and indirect customers; and the historical trend of actual rebate claims paid. Professionals with specialised skill and knowledge were used to assist in assessing the compliance of the Group’s Medicaid rebate policies against the regulatory requirements.
Impairment assessment of the product, marketing and distribution rights and other intangibles
As described in the Group Accounting Policies and Note 10 to the consolidated financial statements, the Group has product, marketing and distribution rights totalling $36,941 million and other intangibles totalling $646 million (hereafter the intangible assets) at 31 December 2023. Management performs an impairment trigger assessment for all intangible assets. Intangible assets under development and not available for use are tested annually for impairment and other intangible assets are tested when there is an indication of impairment loss or reversal. Where testing is required, the recoverable amount of the assets is estimated in order to determine the extent of impairment loss or reversal. Where it is not possible to estimate the recoverable amount of an individual asset, the Group estimates the recoverable amount of the Cash Generating Unit (CGU) to which it belongs. Group level budgets and forecasts include forecast capital investment and operational impacts related to sustainability projects, as well as inflationary impacts, and form the basis for the value in use models used for impairment testing. An asset’s recoverable amount is determined as the higher of an asset’s or CGU’s fair value less costs to sell or value in use, in both cases using discounted cash flow calculations where the asset’s expected post-tax cash flows are risk-adjusted over their estimated remaining period of expected economic benefit. The key assumptions and significant estimates used in calculating the recoverable amounts are highly sensitive. The key assumptions include the outcome of research and development activities, probability of technical and regulatory success, market volume, share and pricing (to derive peak year sales), the amount and timing of projected future cash flows, and sales erosion curves following patent expiry. In 2023, the Group recorded impairment charges of $434 million related to product, marketing and distribution rights.
The principal considerations for our determination that performing procedures relating to the impairment assessment of the product, marketing and distribution rights and other intangibles is a critical audit matter are the significant judgements made by management when determining the recoverable amount of the Group’s individual assets or CGUs. This in turn led to a high degree of auditor judgement, subjectivity, and effort in performing procedures and evaluating assumptions in management’s cash flow projections related to the probability of technical and regulatory success, peak year sales and sales erosion curves following patent expiry. In addition, the audit effort involved the use of professionals with specialised skill and knowledge.
58
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s intangible asset impairment assessment, controls over the identification of triggering events and the development of assumptions used to estimate the recoverable amounts of the Group’s CGUs. These procedures also included, among others, testing management’s process for identifying indicators for impairment and for determining the recoverable amount of the Group’s individual assets or CGUs. Testing management’s process involved a) evaluating the reasonableness of significant assumptions of i) probability of technical and regulatory success, with the assistance of professionals with specialised skill and knowledge and ii) amount and timing of projected future cash flows (in particular, the drivers of peak year sales and sales erosion curves following patent expiry); and b) reconciling the cash flows to the Board approved Group level budgets and forecasts. Evaluating management’s assumptions related to the probability of technical and regulatory success and the amount and timing of projected future cash flows involved evaluating whether the assumptions used were reasonable through (1) comparing significant assumptions to external data and benchmarks; and (2) performing a retrospective comparison of past forecasted revenues to actual past performance.
Recognition and measurement of legal provisions and disclosure of contingent liabilities
As described in the Group Accounting Policies, Note 21 and Note 30 to the consolidated financial statements, the Group is involved in various legal proceedings considered typical to its business, including actual or threatened litigation and actual or potential government investigations relating to employment matters, product liability, commercial disputes, pricing, sales and marketing practices, infringement of IP rights and the validity of certain patents and competition laws. Most of the claims involve highly complex issues. Often these issues are subject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or an estimate of the amount of any loss is difficult to ascertain. As at 31 December 2023 the Group held legal provisions of $1,016 million and disclosed the more significant legal matters. Provisions are recognised when either a legal or constructive obligation as a result of a past event exists, it is probable that an outflow of economic resources will be required to settle the obligation and a reasonable estimate can be made of the amount of the obligation. Provision is made where an adverse outcome is probable and associated costs, including related legal costs, can be estimated reliably. Management’s assessment as to whether or not to recognise provisions or assets, and of the amounts concerned, usually involves a series of complex judgements about future events and can rely heavily on estimates and assumptions. Determining the timing of recognition of when an adverse outcome is probable is considered a key judgement.
The principal considerations for our determination that performing procedures related to recognition and measurement of legal provisions and disclosure of contingent liabilities is a critical audit matter are the significant judgement by management when assessing whether an adverse outcome is probable and can be estimated reliably, which in turn led to a high degree of auditor judgement and subjectivity in performing procedures and evaluating management’s assessment of the legal provisions and disclosures of contingent liabilities.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s evaluation of the liability of legal claims, including controls over determining the probability of a loss and whether the amount of loss can be reasonably estimated, as well as financial statement disclosures. These procedures also included, among others, (i) obtaining and evaluating letters of audit inquiry with internal and external legal counsel for significant litigation; (ii) testing the completeness of management’s assessment of both the identification of legal claims and possible outcomes of each significant legal claim; (iii) evaluating the reasonableness of management’s assessment regarding whether an adverse outcome is probable and estimated reliably; (iv) inspecting certain external legal documents; and (v) evaluating the sufficiency of the Group’s legal provisions and contingent liabilities disclosures.
Recognition, measurement and disclosure of tax liabilities for uncertain tax treatments
As described in the Group Accounting Policies and Note 30 to the consolidated financial statements, the Group faces a number of audits and reviews in jurisdictions around the world and, in some cases, is in dispute with the tax authorities. As at 31 December 2023 the total net tax liability recognised in respect of uncertain tax positions is $1,336 million and the potential for additional liabilities where the possibility of the additional liabilities falling due is more than remote is (a) $386 million related to transfer pricing matters including items under tax audit, and (b) $293 million related to other tax liabilities where the Group estimates the potential for additional liabilities above the amount provided. Tax liabilities recognised for uncertain tax treatments require management to make key judgements with respect to the outcome of current and potential future tax audits, and actual results could vary from these estimates. Accruals for tax liabilities are measured using either the most likely amount or the expected value amount depending on which method management expects to better predict the resolution of the uncertainty.
59
The principal considerations for our determination that performing procedures relating to recognition, measurement and disclosure of tax liabilities for uncertain tax treatments is a critical audit matter are the significant judgement made by management to estimate the tax liability, and the significant estimation uncertainty relative to the expectation of the resolution of tax audits or other disputes with tax authorities. This in turn led to a high degree of auditor judgement, subjectivity, and effort in performing procedures and evaluating management’s key judgements with respect to the outcome, estimation and recognition of current and potential future tax audits. In addition, the audit effort involved the use of professionals with specialised skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the identification, recognition and measurement of accruals for tax liabilities. These procedures also included, among others, testing management’s process for determining tax liabilities and uncertain tax treatments for which no tax liability is recognised; i) evaluating the completeness of management’s assessment of the identification of tax liabilities and evaluating management’s process for estimating the possible outcomes of each tax liability; ii) obtaining the status and results of tax audits and discussions with the relevant tax authorities; iii) testing the completeness and accuracy of underlying data used in the estimate; iv) evaluating the reasonableness of key judgements related to the outcome of tax audits and tax liabilities using the most likely amount or expected value depending on the resolution of the uncertainty; and v) evaluating the sufficiency of the Group’s disclosures where no tax liability is recognised. Professionals with specialised skill and knowledge were used to assist in evaluating the method used by management to measure accruals for tax contingencies, and to evaluate management’s key judgements with respect to the outcome of tax audits considering the technical merits of tax treatments and advice, if any, received from the Group’s external advisors.
Valuation of defined benefit obligations (in the UK and Sweden)
As described in the Group Accounting Policies and Note 22 to the consolidated financial statements, the Group and most of its subsidiaries offer retirement plans which cover the majority of its employees. Several of these plans are defined benefit, where benefits are based on employees’ length of service and linked to their salary. As at 31 December 2023 the Group had defined benefit obligations of $7,907 million mainly in the UK and Sweden. Qualified independent actuaries have updated the actuarial valuations under IAS 19 for the major defined benefit schemes operated by the Group to 31 December 2023. In respect of defined benefit plans, obligations are determined using the projected unit credit method and are discounted to present value by reference to market yields on high quality corporate bonds. Given the extent of the assumptions used to determine the value of scheme liabilities, these are considered to be significant estimates. The assumptions which had the most material impact on the results of the Group were mortality rate (for the UK scheme only), discount rates and inflation levels (for both the UK and Sweden schemes).
The principal considerations for our determination that performing procedures relating to the valuation of defined benefit obligations (in the UK and Sweden) is a critical audit matter are the significant judgement made by management in determining the discount rate, inflation and mortality rates (UK) assumptions. This in turn led to a high degree of auditor judgement and subjectivity in applying procedures relating to these assumptions. In addition, the audit effort involved the use of professionals with specialised skill and knowledge to assist in performing these procedures and evaluating audit evidence.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the assumptions used and the accuracy of the obligations. These procedures also included, among others, (i) the involvement of professionals with specialised skill and knowledge to assist in developing an independent expectation of the defined benefit obligations for the UK and Sweden, (ii) comparing the independent estimate to management’s estimate to evaluate the reasonableness of management’s estimate, and (iii) testing the completeness and accuracy of the underlying data used in the models. Developing the independent estimate involved independently deriving inflation, discount rate and mortality assumptions by evaluating the specifics of each plan and, where applicable, considering national information, and comparing the discount and inflation rates with developed ranges of recent external reporting of other companies.
/s/ PricewaterhouseCoopers LLP
London, United Kingdom
8 February 2024
We have served as the Group’s auditor since 2017.
60
ITEM 19. EXHIBITS(1)
1.1 |
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2.1 |
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4.1 |
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4.2 |
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4.3 |
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8.1 |
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12.1 |
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12.2 |
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13.1 |
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15.1 |
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15.2 |
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Consent of PricewaterhouseCoopers LLP, independent registered public accounting firm. |
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15.3 |
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15.4 |
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17.1 |
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List of subsidiary guarantors and issuers of guaranteed securities. |
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97.1 |
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AstraZeneca US Clawback Policy Applicable to Executive Officers. |
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101.INS |
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XBRL Instance Document. |
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101.SCH |
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XBRL Taxonomy Extension Schema. |
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101.CAL |
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XBRL Taxonomy Extension Scheme Calculation Linkbase. |
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101.DEF |
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XBRL Taxonomy Extension Scheme Definition Linkbase. |
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101.LAB |
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XBRL Taxonomy Extension Scheme Label Linkbase. |
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101.PRE |
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XBRL Taxonomy Extension Scheme Presentation Linkbase. |
| (1) | Exhibits other than those listed above are omitted when in the opinion of the registrant they are either not applicable or not material. Other Exhibits previously filed have been omitted when in the opinion of the registrant such Exhibits are no longer material. |
| (2) | Certain of the information included within Exhibit 15.1, which is provided pursuant to Rule 12b-23(a)(3) of the Securities Exchange Act of 1934, as amended, is incorporated by reference in this Form 20-F, as specified elsewhere in this Form 20-F. With the exception of the items and pages so specified, the Annual Report and Form 20-F Information 2023 is not deemed to be filed as part of this Annual Report on Form 20-F. |
61
SIGNATURE
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
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AstraZeneca PLC |
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By: |
/s/ Adrian Kemp |
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Name: |
Adrian Kemp |
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Title: |
Company Secretary |
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London, England |
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February 20, 2024 |
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62
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
INDEX TO FINANCIAL STATEMENTS
F-2 |
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F-3 |
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F-4 |
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F-5 |
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F-6 |
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F-14 |
F-1
Consolidated Statement of Comprehensive Income
for the year ended 31 December
|
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2023 |
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2022 |
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2021 |
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Notes |
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$m |
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|
$m |
|
|
$m |
|
Product Sales |
|
1 |
|
|
43,789 |
|
|
42,998 |
|
|
36,541 |
|
Alliance Revenue |
|
1 |
|
|
1,428 |
|
|
755 |
|
|
388 |
|
Collaboration Revenue |
|
1 |
|
|
594 |
|
|
598 |
|
|
488 |
|
Total Revenue |
|
|
|
|
45,811 |
|
|
44,351 |
|
|
37,417 |
|
Cost of sales |
|
|
|
|
(8,268) |
|
|
(12,391) |
|
|
(12,437) |
|
Gross profit |
|
|
|
|
37,543 |
|
|
31,960 |
|
|
24,980 |
|
Distribution expense |
|
|
|
|
(539) |
|
|
(536) |
|
|
(446) |
|
Research and development expense |
|
2 |
|
|
(10,935) |
|
|
(9,762) |
|
|
(9,736) |
|
Selling, general and administrative expense |
|
2 |
|
|
(19,216) |
|
|
(18,419) |
|
|
(15,234) |
|
Other operating income and expense |
|
2 |
|
|
1,340 |
|
|
514 |
|
|
1,492 |
|
Operating profit |
|
|
|
|
8,193 |
|
|
3,757 |
|
|
1,056 |
|
Finance income |
|
3 |
|
|
344 |
|
|
95 |
|
|
43 |
|
Finance expense |
|
3 |
|
|
(1,626) |
|
|
(1,346) |
|
|
(1,300) |
|
Share of after tax losses in associates and joint ventures |
|
11 |
|
|
(12) |
|
|
(5) |
|
|
(64) |
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Profit/(loss) before tax |
|
|
|
|
6,899 |
|
|
2,501 |
|
|
(265) |
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Taxation |
|
4 |
|
|
(938) |
|
|
792 |
|
|
380 |
|
Profit for the period |
|
|
|
|
5,961 |
|
|
3,293 |
|
|
115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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Other comprehensive income: |
|
|
|
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|
|
|
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|
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Items that will not be reclassified to profit or loss: |
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|
|
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|
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|
|
|
|
|
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Remeasurement of the defined benefit pension liability |
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22 |
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|
(406) |
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1,118 |
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626 |
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Net gains/(losses) on equity investments measured at fair value through other comprehensive income |
|
|
|
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278 |
|
|
(88) |
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|
(187) |
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Fair value movements related to own credit risk on bonds designated as fair value through profit or loss |
|
|
|
|
(6) |
|
|
2 |
|
|
– |
|
Tax on items that will not be reclassified to profit or loss |
|
4 |
|
|
101 |
|
|
(216) |
|
|
105 |
|
|
|
|
|
|
(33) |
|
|
816 |
|
|
544 |
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange arising on consolidation |
|
23 |
|
|
608 |
|
|
(1,446) |
|
|
(483) |
|
Foreign exchange arising on designated liabilities in net investment hedges |
|
23 |
|
|
24 |
|
|
(282) |
|
|
(321) |
|
Fair value movements on cash flow hedges |
|
|
|
|
266 |
|
|
(97) |
|
|
(167) |
|
Fair value movements on cash flow hedges transferred to profit and loss |
|
|
|
|
(145) |
|
|
73 |
|
|
208 |
|
Fair value movements on derivatives designated in net investment hedges |
|
23 |
|
|
44 |
|
|
(8) |
|
|
34 |
|
Costs of hedging |
|
|
|
|
(19) |
|
|
(7) |
|
|
(6) |
|
Tax on items that may be reclassified subsequently to profit or loss |
|
4 |
|
|
(12) |
|
|
73 |
|
|
46 |
|
|
|
|
|
|
766 |
|
|
(1,694) |
|
|
(689) |
|
Other comprehensive income/(expense) for the period, net of tax |
|
|
|
|
733 |
|
|
(878) |
|
|
(145) |
|
Total comprehensive income/(expense) for the period |
|
|
|
|
6,694 |
|
|
2,415 |
|
|
(30) |
|
Profit attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
Owners of the Parent |
|
|
|
|
5,955 |
|
|
3,288 |
|
|
112 |
|
Non-controlling interests |
|
26 |
|
|
6 |
|
|
5 |
|
|
3 |
|
Total comprehensive income/(expense) attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
Owners of the Parent |
|
|
|
|
6,688 |
|
|
2,413 |
|
|
(33) |
|
Non-controlling interests |
|
26 |
|
|
6 |
|
|
2 |
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per $0.25 Ordinary Share |
|
5 |
|
|
$3.84 |
|
|
$2.12 |
|
|
$0.08 |
|
Diluted earnings per $0.25 Ordinary Share |
|
5 |
|
|
$3.81 |
|
|
$2.11 |
|
|
$0.08 |
|
Weighted average number of Ordinary Shares in issue (millions) |
|
5 |
|
|
1,549 |
|
|
1,548 |
|
|
1,418 |
|
Diluted weighted average number of Ordinary Shares in issue (millions) |
|
5 |
|
|
1,562 |
|
|
1,560 |
|
|
1,427 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared and paid in the period |
|
25 |
|
|
4,487 |
|
|
4,485 |
|
|
3,882 |
|
All activities were in respect of continuing operations.
$m means millions of US dollars.
F-2
Consolidated Statement of Financial Position
at 31 December
|
|
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
Notes |
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$m |
|
$m |
|
$m |
|
Assets |
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
|
|
Property, plant and equipment |
|
7 |
|
9,402 |
|
8,507 |
|
9,183 |
|
Right-of-use assets |
|
8 |
|
1,100 |
|
942 |
|
988 |
|
Goodwill |
|
9 |
|
20,048 |
|
19,820 |
|
19,997 |
|
Intangible assets |
|
10 |
|
38,089 |
|
39,307 |
|
42,387 |
|
Investments in associates and joint ventures |
|
11 |
|
147 |
|
76 |
|
69 |
|
Other investments |
|
12 |
|
1,530 |
|
1,066 |
|
1,168 |
|
Derivative financial instruments |
|
13 |
|
228 |
|
74 |
|
102 |
|
Other receivables |
|
14 |
|
803 |
|
835 |
|
895 |
|
Deferred tax assets |
|
4 |
|
4,718 |
|
3,263 |
|
4,330 |
|
|
|
|
|
76,065 |
|
73,890 |
|
79,119 |
|
Current assets |
|
|
|
|
|
|
|
|
|
Inventories |
|
15 |
|
5,424 |
|
4,699 |
|
8,983 |
|
Trade and other receivables |
|
16 |
|
12,126 |
|
10,521 |
|
9,644 |
|
Other investments |
|
12 |
|
122 |
|
239 |
|
69 |
|
Derivative financial instruments |
|
13 |
|
116 |
|
87 |
|
83 |
|
Intangible assets |
|
10 |
|
– |
|
– |
|
105 |
|
Income tax receivable |
|
|
|
1,426 |
|
731 |
|
663 |
|
Cash and cash equivalents |
|
17 |
|
5,840 |
|
6,166 |
|
6,329 |
|
Assets held for sale |
|
18 |
|
– |
|
150 |
|
368 |
|
|
|
|
|
25,054 |
|
22,593 |
|
26,244 |
|
Total assets |
|
|
|
101,119 |
|
96,483 |
|
105,363 |
|
Liabilities |
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
|
Interest-bearing loans and borrowings |
|
19 |
|
(5,129) |
|
(5,314) |
|
(1,660) |
|
Lease liabilities |
|
8 |
|
(271) |
|
(228) |
|
(233) |
|
Trade and other payables |
|
20 |
|
(22,374) |
|
(19,040) |
|
(18,938) |
|
Derivative financial instruments |
|
13 |
|
(156) |
|
(93) |
|
(79) |
|
Provisions |
|
21 |
|
(1,028) |
|
(722) |
|
(768) |
|
Income tax payable |
|
|
|
(1,584) |
|
(896) |
|
(916) |
|
|
|
|
|
(30,542) |
|
(26,293) |
|
(22,594) |
|
Non-current liabilities |
|
|
|
|
|
|
|
|
|
Interest-bearing loans and borrowings |
|
19 |
|
(22,365) |
|
(22,965) |
|
(28,134) |
|
Lease liabilities |
|
8 |
|
(857) |
|
(725) |
|
(754) |
|
Derivative financial instruments |
|
13 |
|
(38) |
|
(164) |
|
(45) |
|
Deferred tax liabilities |
|
4 |
|
(2,844) |
|
(2,944) |
|
(6,206) |
|
Retirement benefit obligations |
|
22 |
|
(1,520) |
|
(1,168) |
|
(2,454) |
|
Provisions |
|
21 |
|
(1,127) |
|
(896) |
|
(956) |
|
Other payables |
|
20 |
|
(2,660) |
|
(4,270) |
|
(4,933) |
|
|
|
|
|
(31,411) |
|
(33,132) |
|
(43,482) |
|
Total liabilities |
|
|
|
(61,953) |
|
(59,425) |
|
(66,076) |
|
Net assets |
|
|
|
39,166 |
|
37,058 |
|
39,287 |
|
Equity |
|
|
|
|
|
|
|
|
|
Capital and reserves attributable to equity holders of the Company |
|
|
|
|
|
|
|
|
|
Share capital |
|
24 |
|
388 |
|
387 |
|
387 |
|
Share premium account |
|
|
|
35,188 |
|
35,155 |
|
35,126 |
|
Capital redemption reserve |
|
|
|
153 |
|
153 |
|
153 |
|
Merger reserve |
|
|
|
448 |
|
448 |
|
448 |
|
Other reserves |
|
23 |
|
1,464 |
|
1,468 |
|
1,444 |
|
Retained earnings |
|
23 |
|
1,502 |
|
(574) |
|
1,710 |
|
|
|
|
|
39,143 |
|
37,037 |
|
39,268 |
|
Non-controlling interests |
|
26 |
|
23 |
|
21 |
|
19 |
|
Total equity |
|
|
|
39,166 |
|
37,058 |
|
39,287 |
|
The Financial Statements from pages 148 to 215 were approved by the Board and were signed on its behalf by
Pascal Soriot |
Aradhana Sarin |
Director |
Director |
8 February 2024 |
|
F-3
Consolidated Statement of Changes in Equity
for the year ended 31 December
|
|
|
|
Share |
|
Capital |
|
|
|
|
|
|
|
Total |
|
Non- |
|
|
|
|
|
Share |
|
premium |
|
redemption |
|
Merger |
|
Other |
|
Retained |
|
attributable |
|
controlling |
|
Total |
|
|
|
capital |
|
account |
|
reserve |
|
reserve |
|
reserves |
|
earnings |
|
to owners |
|
interests |
|
equity |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
At 1 January 2021 |
|
328 |
|
7,971 |
|
153 |
|
448 |
|
1,423 |
|
5,299 |
|
15,622 |
|
16 |
|
15,638 |
|
Profit for the period |
|
– |
|
– |
|
– |
|
– |
|
– |
|
112 |
|
112 |
|
3 |
|
115 |
|
Other comprehensive expense1 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(145) |
|
(145) |
|
– |
|
(145) |
|
Transfer to other reserves2 |
|
– |
|
– |
|
– |
|
– |
|
21 |
|
(21) |
|
– |
|
– |
|
– |
|
Transactions with owners |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends (Note 25) |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(3,882) |
|
(3,882) |
|
– |
|
(3,882) |
|
Issue of Ordinary Shares |
|
59 |
|
27,155 |
|
– |
|
– |
|
– |
|
– |
|
27,214 |
|
– |
|
27,214 |
|
Share-based payments charge for the period (Note 29) |
|
– |
|
– |
|
– |
|
– |
|
– |
|
615 |
|
615 |
|
– |
|
615 |
|
Settlement of share plan awards |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(781) |
|
(781) |
|
– |
|
(781) |
|
Issue of replacement Alexion share awards upon acquisition (Note 27)3 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
513 |
|
513 |
|
– |
|
513 |
|
Net movement |
|
59 |
|
27,155 |
|
– |
|
– |
|
21 |
|
(3,589) |
|
23,646 |
|
3 |
|
23,649 |
|
At 31 December 2021 |
|
387 |
|
35,126 |
|
153 |
|
448 |
|
1,444 |
|
1,710 |
|
39,268 |
|
19 |
|
39,287 |
|
Profit for the period |
|
– |
|
– |
|
– |
|
– |
|
– |
|
3,288 |
|
3,288 |
|
5 |
|
3,293 |
|
Other comprehensive expense1 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(875) |
|
(875) |
|
(3) |
|
(878) |
|
Transfer to other reserves2 |
|
– |
|
– |
|
– |
|
– |
|
24 |
|
(24) |
|
– |
|
– |
|
– |
|
Transactions with owners |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends (Note 25) |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(4,485) |
|
(4,485) |
|
– |
|
(4,485) |
|
Issue of Ordinary Shares |
|
– |
|
29 |
|
– |
|
– |
|
– |
|
– |
|
29 |
|
– |
|
29 |
|
Share-based payments charge for the period (Note 29) |
|
– |
|
– |
|
– |
|
– |
|
– |
|
619 |
|
619 |
|
– |
|
619 |
|
Settlement of share plan awards |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(807) |
|
(807) |
|
– |
|
(807) |
|
Net movement |
|
– |
|
29 |
|
– |
|
– |
|
24 |
|
(2,284) |
|
(2,231) |
|
2 |
|
(2,229) |
|
At 31 December 2022 |
|
387 |
|
35,155 |
|
153 |
|
448 |
|
1,468 |
|
(574) |
|
37,037 |
|
21 |
|
37,058 |
|
Profit for the period |
|
– |
|
– |
|
– |
|
– |
|
– |
|
5,955 |
|
5,955 |
|
6 |
|
5,961 |
|
Other comprehensive income1 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
733 |
|
733 |
|
– |
|
733 |
|
Transfer to other reserves2 |
|
– |
|
– |
|
– |
|
– |
|
(4) |
|
4 |
|
– |
|
– |
|
– |
|
Transactions with owners |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends (Note 25) |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(4,487) |
|
(4,487) |
|
– |
|
(4,487) |
|
Dividends paid to non-controlling interests (Note 25) |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(4) |
|
(4) |
|
Issue of Ordinary Shares |
|
1 |
|
33 |
|
– |
|
– |
|
– |
|
– |
|
34 |
|
– |
|
34 |
|
Share-based payments charge for the period (Note 29) |
|
– |
|
– |
|
– |
|
– |
|
– |
|
579 |
|
579 |
|
– |
|
579 |
|
Settlement of share plan awards |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(708) |
|
(708) |
|
– |
|
(708) |
|
Net movement |
|
1 |
|
33 |
|
– |
|
– |
|
(4) |
|
2,076 |
|
2,106 |
|
2 |
|
2,108 |
|
At 31 December 2023 |
|
388 |
|
35,188 |
|
153 |
|
448 |
|
1,464 |
|
1,502 |
|
39,143 |
|
23 |
|
39,166 |
|
F-4
Consolidated Statement of Cash Flows
for the year ended 31 December
|
|
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
Notes |
|
$m |
|
$m |
|
$m |
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
|
Profit/(loss) before tax |
|
|
|
6,899 |
|
2,501 |
|
(265) |
|
Finance income and expense |
|
3 |
|
1,282 |
|
1,251 |
|
1,257 |
|
Share of after tax losses of associates and joint ventures |
|
11 |
|
12 |
|
5 |
|
64 |
|
Depreciation, amortisation and impairment |
|
|
|
5,387 |
|
5,480 |
|
6,530 |
|
Increase in trade and other receivables |
|
|
|
(1,425) |
|
(1,349) |
|
(961) |
|
(Increase)/decrease in inventories |
|
|
|
(669) |
|
3,941 |
|
1,577 |
|
Increase in trade and other payables and provisions |
|
|
|
2,394 |
|
1,165 |
|
1,405 |
|
Gains on disposal of intangible assets |
|
2 |
|
(251) |
|
(104) |
|
(513) |
|
Gains on disposal of investments in associates and joint ventures |
|
2 |
|
– |
|
– |
|
(776) |
|
Fair value movements on contingent consideration arising from business combinations |
|
20 |
|
549 |
|
82 |
|
14 |
|
Non-cash and other movements |
|
17 |
|
(386) |
|
(692) |
|
95 |
|
Cash generated from operations |
|
|
|
13,792 |
|
12,280 |
|
8,427 |
|
Interest paid |
|
|
|
(1,081) |
|
(849) |
|
(721) |
|
Tax paid |
|
|
|
(2,366) |
|
(1,623) |
|
(1,743) |
|
Net cash inflow from operating activities |
|
|
|
10,345 |
|
9,808 |
|
5,963 |
|
Cash flows from investing activities |
|
|
|
|
|
|
|
|
|
Acquisition of subsidiaries, net of cash acquired |
|
27 |
|
(189) |
|
(48) |
|
(9,263) |
|
Payments upon vesting of employee share awards attributable to business combinations |
|
27 |
|
(84) |
|
(215) |
|
(211) |
|
Payment of contingent consideration from business combinations |
|
20 |
|
(826) |
|
(772) |
|
(643) |
|
Purchase of property, plant and equipment |
|
|
|
(1,361) |
|
(1,091) |
|
(1,091) |
|
Disposal of property, plant and equipment |
|
|
|
132 |
|
282 |
|
13 |
|
Purchase of intangible assets |
|
|
|
(2,417) |
|
(1,480) |
|
(1,109) |
|
Disposal of intangible assets |
|
|
|
291 |
|
447 |
|
587 |
|
Movement in profit-participation liability |
|
2 |
|
190 |
|
– |
|
20 |
|
Purchase of non-current asset investments |
|
|
|
(136) |
|
(45) |
|
(184) |
|
Disposal of non-current asset investments |
|
|
|
32 |
|
42 |
|
9 |
|
Movement in short-term investments, fixed deposits and other investing instruments |
|
|
|
97 |
|
(114) |
|
96 |
|
Payments to associates and joint ventures |
|
11 |
|
(80) |
|
(26) |
|
(92) |
|
Disposal of investments in associates and joint ventures |
|
|
|
– |
|
– |
|
776 |
|
Interest received |
|
|
|
287 |
|
60 |
|
34 |
|
Net cash outflow from investing activities |
|
|
|
(4,064) |
|
(2,960) |
|
(11,058) |
|
Net cash inflow/(outflow) before financing activities |
|
|
|
6,281 |
|
6,848 |
|
(5,095) |
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
|
Proceeds from issue of share capital |
|
|
|
33 |
|
29 |
|
29 |
|
Issue of loans and borrowings |
|
|
|
3,816 |
|
– |
|
12,929 |
|
Repayment of loans and borrowings |
|
|
|
(4,942) |
|
(1,271) |
|
(4,759) |
|
Dividends paid |
|
|
|
(4,481) |
|
(4,364) |
|
(3,856) |
|
Hedge contracts relating to dividend payments |
|
|
|
(19) |
|
(127) |
|
(29) |
|
Repayment of obligations under leases |
|
|
|
(268) |
|
(244) |
|
(240) |
|
Movement in short-term borrowings |
|
|
|
161 |
|
74 |
|
(276) |
|
Payments to acquire non-controlling interests |
|
|
|
– |
|
– |
|
(149) |
|
Payment of Acerta Pharma share purchase liability |
|
|
|
(867) |
|
(920) |
|
– |
|
Net cash (outflow)/inflow from financing activities |
|
|
|
(6,567) |
|
(6,823) |
|
3,649 |
|
Net (decrease)/increase in Cash and cash equivalents in the period |
|
|
|
(286) |
|
25 |
|
(1,446) |
|
Cash and cash equivalents at the beginning of the period |
|
|
|
5,983 |
|
6,038 |
|
7,546 |
|
Exchange rate effects |
|
|
|
(60) |
|
(80) |
|
(62) |
|
Cash and cash equivalents at the end of the period |
|
17 |
|
5,637 |
|
5,983 |
|
6,038 |
|
F-5
Group Accounting Policies
Basis of accounting and preparation of financial information
The Consolidated Financial Statements have been prepared under the historical cost convention, modified to include revaluation to fair value of certain financial instruments and pension plan assets and liabilities as described below, in accordance with UK-adopted international accounting standards and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards. The Consolidated Financial Statements also comply fully with IFRS Accounting Standards as issued by the International Accounting Standards Board (IASB) and International Accounting Standards as adopted by the European Union.
The Consolidated Financial Statements are presented in US dollars, which is the Company’s functional currency.
In preparing their individual financial statements, the accounting policies of some overseas subsidiaries do not conform with IASB-issued IFRSs. Therefore, where appropriate, adjustments are made in order to present the Consolidated Financial Statements on a consistent basis.
New accounting requirements
Other than noted below, amendments to accounting standards issued by the IASB and adopted in the year ended 31 December 2023 did not have a material impact on the result or financial position of the Group.
IAS 12
On 23 May 2023, the IASB issued an amendment to IAS 12 ‘Income Taxes’ to clarify how the effects of the global minimum tax framework should be accounted for and disclosed effective 1 January 2023. This was endorsed by the UK Endorsement Board on 19 July 2023 and has been adopted by the Group for 2023 reporting. The Group has applied the exemption to recognising and disclosing information about deferred tax assets and liabilities related to Pillar 2 income taxes.
Alliance and Collaboration Revenue
Effective 1 January 2023, the Group has updated the presentation of Total Revenue on the face of the Statement of Comprehensive Income to include Alliance Revenue as a separate element to Collaboration Revenue. Alliance Revenue, previously reported within Collaboration Revenue, comprises income related to sales made by collaboration partners, where AstraZeneca is entitled to a share of gross profits, share of revenues or royalties, which are recurring in nature while the collaboration arrangement remains in place. Alliance Revenue does not include Product Sales where AstraZeneca is leading commercialisation in a territory.
Collaboration Revenue arising from collaborative arrangements where the Group retains a significant ongoing economic interest and receives upfront amounts and event-triggered milestones, which arise from the licensing of intellectual property, will continue to be reported as Collaboration Revenue. In collaboration arrangements either AstraZeneca or the collaborator acts as principal in sales to the end customer. Where AstraZeneca acts as principal, AstraZeneca records 100% of sales to the end customer within Product Sales. The updated presentation reflects the increasing importance of income arising from share of gross profit arrangements where collaboration partners are responsible for booking revenues in some or all territories.
The comparative revenue reported in the years to 31 December 2022 and 31 December 2021 has been retrospectively adjusted to reflect the new split of Total Revenue, resulting in Alliance Revenue being reported for the year to 31 December 2022 of $755m and to 31 December 2021 of $388m, however the combined total of Alliance Revenue and Collaboration Revenue is equal to the previously reported Collaboration Revenue total for each prior year.
Basis for preparation of Financial Statements on a going concern basis
The Group has considerable financial resources available. As at 31 December 2023, the Group has $12.7bn in financial resources (Cash and cash equivalent balances of $5.8bn and undrawn committed bank facilities of $6.9bn, of which $2.0bn are available until February 2025 and the remaining $4.9bn are available until April 2026, (in February 2024 these facilities were extended to April 2029), with only $5.4bn of borrowings due within one year).
The Group’s revenues are largely derived from sales of medicines covered by patents, which provide a relatively high level of resilience and predictability to cash inflows, although government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues in some of our significant markets. The Group, however, anticipates new revenue streams from both recently launched medicines and those in development, and the Group has a wide diversity of customers and suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully. Accordingly, they continue to adopt the going concern basis in preparing the Annual Report and Financial Statements.
Estimates and judgements
The preparation of the Financial Statements in conformity with generally accepted accounting principles requires management to make estimates and judgements that affect the reported amounts of assets and liabilities at the date of the Financial Statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
The accounting policy descriptions set out the areas where judgements and estimates need exercising, the most significant of which include the following Key Judgements and Significant Estimates:
| > | revenue recognition – see Revenue Accounting Policy from page 152 and Note 1 on page 161 |
| > | expensing of internal development expenses – see Research and Development Policy from page 154 |
| > | impairment reviews of Intangible assets – see Note 10 on page 174 |
| > | useful economic life of Intangible assets – see Research and Development Policy from page 154 |
| > | business combinations and Goodwill – see Business Combinations and Goodwill Policy from page 156 and Note 27 from page 193 |
| > | litigation liabilities – see Litigation and Environmental Liabilities within Note 30 on page 204 |
| > | operating segments – see Note 6 on page 167 |
| > | employee benefits – see Note 22 on page 190 |
| > | taxation – see Note 30 from page 209. |
The Group has assessed the impact of climate risk on its financial reporting. The impact assessment was primarily focused on the valuation and useful lives of intangible assets and the identification and valuation of provisions and contingent liabilities, as these are judged to be the key areas that could be impacted by climate risks. No material accounting impacts or changes to judgements or other required disclosures were noted.
Key Judgements are those judgements made in applying the Group’s accounting policies that have a material effect on the amounts of assets and liabilities recognised in the Financial Statements.
F-6
A Significant Estimate has a significant risk of material adjustment to the carrying amounts of assets and liabilities within the next financial year.
Financial risk management policies are detailed in Note 28 to the Financial Statements from page 195.
AstraZeneca’s management considers the following to be the material accounting policies in the context of the Group’s operations.
Revenue
Revenue comprises Product Sales, Alliance Revenue and Collaboration Revenue.
Revenue excludes inter-company revenues and value-added taxes.
Product Sales
Product Sales represent net invoice value less estimated rebates, returns and chargebacks, which are considered to be variable consideration and include significant estimates. Sales are recognised when the control of the goods has been transferred to a third party. This is usually when title passes to the customer, either on shipment or on receipt of goods by the customer, depending on local trading terms. Revenue is not recognised in full until it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur.
Rebates are amounts payable or credited to a customer, usually based on the quantity or value of Product Sales to the customer for specific products in a certain period. Product sales rebates, which relate to Product Sales that occur over a period of time, are normally issued retrospectively.
At the time Product Sales are invoiced, rebates and deductions that the Group expects to pay are estimated based upon assumptions developed using contractual terms, historical experience and market-related information. The rebates and deductions are recognised as variable consideration and recorded as a reduction to revenue with an accrual recorded. These rebates typically arise from sales contracts with government payers, third-party managed care organisations, hospitals, long-term care facilities, group purchasing organisations and various state programmes.
In markets where returns are significant, estimates of the quantity and value of goods which may ultimately be returned are accounted for at the point revenue is recognised. Our returns accruals are based on actual experience over the preceding 12 months for established products together with market-related information such as estimated stock levels at wholesalers and competitor activity which we receive via third-party information services. For newly launched products, we use rates based on our experience with similar products or a predetermined percentage.
When a product faces generic competition, particular attention is given to the possible levels of returns and, in cases where the circumstances are such that the level of Product Sales are considered highly probable to reverse, revenues are only recognised when the right of return expires, which is generally on ultimate prescription of the product to patients.
The methodology and assumptions used to estimate rebates and returns are monitored and adjusted regularly in the light of contractual and legal obligations, historical trends, past experience and projected market conditions. Once the uncertainty associated with returns is resolved, revenue is adjusted accordingly.
Under certain collaboration agreements which include a profit sharing mechanism, our recognition of Product Sales depends on which party acts as principal in sales to the end customer. In the cases where AstraZeneca acts as principal, we record 100% of sales to the end customer. In the cases where AstraZeneca does not act as principal, we record the share of gross profits received within Alliance Revenue.
Contracts relating to the supply of certain Vaccines & Immune Therapies medicines relating to the COVID-19 pandemic include conditions whereby payments are receivable from customers in advance of the delivery of product. Such amounts are held on the balance sheet as contract liabilities until the related revenue is recognised, generally upon product delivery. Certain of these contracts contain further provisions that restrict the use of inventory manufactured in specified supply chains to specified customers, resulting in an enforceable right to payment as the activities are performed. Under IFRS 15, such contracts require revenue to be recognised over time using an appropriate and reasonably measurable method to measure progress. Revenue is recognised on these contracts based on the proportion of product delivered compared to the total contracted volumes.
Certain arrangements include bill-and-hold arrangements under which the Group invoices a customer for a product but retains physical possession of the product until it is transferred to the customer at a point in time in the future. For these types of arrangements, an assessment is made to determine when the performance obligation has been satisfied, which is when control of the product is transferred to the customer. If the customer has obtained control of the product even though that product remains in the Group's physical possession, the performance obligation to transfer a product has been satisfied and Product Sales are recognised. Control is considered to have transferred when the reason for the bill-and-hold arrangement is substantive, the product can be identified separately as belonging to the customer, the product is ready for physical transfer to the customer and AstraZeneca is unable to use or sell the product to another customer.
Alliance Revenue
Alliance Revenue comprises income arising from the ongoing operation of collaborative arrangements related to sales made by collaboration partners, where AstraZeneca is entitled to a share of gross profits, share of revenues or royalties, which are recurring in nature while the collaboration agreement remains in place. Alliance Revenue does not include Product Sales where AstraZeneca is leading commercialisation in a territory, or reimbursement for AstraZeneca-incurred expenses such as R&D or promotion costs, which arise from the license of intellectual property.
The Group periodically enters into transactions where it acquires part of the rights to a product intangible (either on-market or in-process R&D), but for commercial reasons does not act as principal in selling the product to the customer and therefore does not recognise income from the product in the form of Product Sales. This may occur where, for example, a collaboration partner retains the right to commercialise in a specific territory, and has sufficient local control over that commercialisation to book Product Sales, while the Group instead receives a proportion of the value generated by those Product Sales, either in the form of a royalty, a share of gross profits or a share of revenues.
Where the arrangement meets the definition of a licence agreement, share of gross profits, share of revenues and sales royalties are recognised when achieved by applying the royalty exemption under IFRS 15. All other sales royalties are recognised when considered it is highly probable there will not be a significant reversal of cumulative income. The determination requires estimates to be made in relation to future Product Sales.
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Collaboration Revenue
Collaboration Revenue includes income arising from entering into collaborative arrangements where the Group has out-licensed (sold) certain rights associated with products and where AstraZeneca retains a significant ongoing economic interest in the product. Significant interest can include ongoing supply of finished goods, profit sharing arrangements or being principal in the sales of medicines. These collaborations may include development, manufacturing and/or commercialisation arrangements with the collaborator. Income from out-licences may take the form of upfront fees and milestones.
Timing of recognition of clinical and regulatory milestones is considered to be a key judgement. There can be significant uncertainty over whether it is highly probable that there would not be a significant reversal of revenue in respect of specific milestones if these are recognised before they are triggered due to them being subject to the actions of third parties. In general, where the triggering of a milestone is subject to the decisions of third parties (e.g. the acceptance or approval of a filing by a regulatory authority), the Group does not consider that the threshold for recognition is met until that decision is made.
Where Collaboration Revenue arises from the licensing of the Group’s own intellectual property, the licences we grant are typically rights to use intellectual property which do not change during the period of the licence and therefore related non-conditional revenue is recognised at the point the licence is granted and variable consideration as soon as recognition criteria are met.
Other performance obligations in the contract might include the supply of product. These arrangements typically involve the receipt of an upfront payment, which the contract attributes to the license of the intangible assets, and ongoing receipts for supply, which the contract attributes to the sale of the product we manufacture. In cases where the transaction has two or more components, we account for the delivered item (for example, the transfer of title to the intangible asset) as a separate unit of account and record revenue on delivery of that component. Where practicable, consideration is allocated to performance obligations on the basis of the standalone selling price of each performance obligation. However, where there is a licence of intellectual property, it is not always possible to establish a reliable estimate of the standalone selling price of the licence as they are unique. Therefore, in these rare situations, the residual approach is used to determine the consideration attributable to the licence.
Where fixed amounts are payable over one year from the effective date of a contract, an assessment is made as to whether a significant financing component exists, and if so, the fair value of this component is deferred and recognised as financing income over the period to the expected date of receipt.
Where control of a right to use licence for an intangible asset passes at the outset of an arrangement, revenue is recognised at the point in time control is transferred. Where the substance of a licence arrangement is that of a right to access rights attributable to an intangible asset, revenue, in the form of an upfront fee, is recognised over time, normally on a straight-line basis over the life of the contract. Where the Group provides ongoing development services, revenue in respect of this element is recognised over the duration of those services.
Where Collaboration Revenue is recorded and there is a related intangible asset that is licensed as part of the arrangement, an appropriate amount of that intangible asset is charged to Cost of sales based on an allocation of cost or value to the rights that have been licensed.
Cost of sales
Cost of sales are recognised as the associated revenue is recognised. Cost of sales include manufacturing costs, royalties payable on revenues recognised, movements in provisions for inventories, inventory write-offs and impairment charges in relation to manufacturing assets. Cost of sales also includes co-collaborator sharing of profit arising from collaborations, and foreign exchange gains and losses arising from business trading activities.
Research and development
Research expenditure is charged to profit and loss in the year in which it is incurred.
Internal development expenditure is capitalised only if it meets the recognition criteria of IAS 38 ‘Intangible Assets’. This is considered a key judgement. Where regulatory and other uncertainties are such that the criteria are not met, the expenditure is charged to profit and loss and this is almost invariably the case prior to approval of the drug by the relevant regulatory authority. Where, however, recognition criteria are met, Intangible assets are capitalised and amortised on a straight-line basis over their useful economic lives from product launch. At 31 December 2023, no amounts have met the recognition criteria.
Payments to in-license products and compounds from third parties for new research and development projects (in process research and development) generally take the form of upfront payments, milestones and royalty payments. Where payments made to third parties represent consideration for future research and development activities, an evaluation is made as to the nature of the payments. Such payments are expensed if they represent compensation for sub-contracted research and development services not resulting in a transfer of intellectual property. By contrast, payments are capitalised if they represent compensation for the transfer of identifiable intellectual property developed at the risk of the third party. Such payments may be made once development or regulatory milestones are met and may also be made on the basis of sales volumes once a product is launched. Development and regulatory milestone payments are capitalised as the milestone is triggered. Sales-related payments are accrued and capitalised with reference to the latest Group sales forecasts for approved indications at the present value of expected future cash flows. Assets capitalised are amortised, on a straight-line basis, over their useful economic lives from product launch.
The determination of useful economic life is considered to be a key judgement. On product launch, the Group makes a judgement as to the expected useful economic life with reference to the expiry of associated patents for the product, expectation around the competitive environment specific to the product and our detailed long-term risk-adjusted sales projections compiled annually across the Group and approved by the Board.
The useful economic life can extend beyond patent expiry dependent upon the nature of the product and the complexity of the development and manufacturing process. Significant sales can often be achieved post patent expiration.
Intangible assets
Intangible assets are stated at cost less accumulated amortisation and impairments. Intangible assets relating to products in development are subject to impairment testing annually. All Intangible assets are tested for impairment when there are indications that the carrying value may not be recoverable. The determination of the recoverable amounts include key estimates which are highly sensitive to, and depend upon, key assumptions as detailed in Note 10 to the Financial Statements from page 172.
Impairment reviews have been carried out on all Intangible assets that are in development (and not being amortised), all major intangible assets acquired during the year and all other intangible assets that have had indicators of impairment during the year. Recoverable amount is determined as the higher of value-in-use or fair value less costs to sell using a discounted cash flow calculation, with the products’ expected cash flows risk-adjusted over their estimated remaining useful economic life. Sales forecasts and specific allocated costs (which have both been subject to appropriate senior management review and approval) are risk-adjusted and discounted using appropriate rates based on our post-tax weighted average cost of capital or for fair value less costs to sell, a required rate of return for a market participant. Our weighted average cost of capital reflects factors such as our capital structure and our costs of debt and equity.
F-8
Any impairment losses are recognised immediately in Operating profit. Intangible assets relating to products which fail during development (or for which development ceases for other reasons) are also tested for impairment and are written down to their recoverable amount (which is usually nil).
If, subsequent to an impairment loss being recognised, development restarts or other facts and circumstances change indicating that the impairment is less or no longer exists, the value of the asset is re-estimated and its carrying value is increased to the recoverable amount, but not exceeding the original value, by recognising an impairment reversal in Operating profit.
Government grants
Government grants are recognised in the Consolidated Statement of Comprehensive Income so as to match with the related expenses that they are intended to compensate. Where grants are received in advance of the related expenses, they are initially recognised in the Consolidated Statement of Financial Position under Trade and other payables as deferred income and released to net off against the related expenditure when incurred.
Each contract is assessed to determine whether there are both grant elements and supply of product which need to be separated. In each case, the contracts set out the specified terms for the supply of the product and the provisions for funding for certain costs, primarily research and development associated with the IP. It is considered whether there are any conditions for the funding to be refunded. The consideration in the contract is allocated between the grant and supply elements. The standalone selling price for the supply of products is determined by reference to observed prices with other customers. The amount allocated as a government grant is determined by reference to the specific agreed costs and activities identified in the contract as not directly attributable to the supply of product. Government grants are recorded as an offset to the relevant expense in the Consolidated Statement of Comprehensive Income and are capped to match the relevant costs incurred.
Other operating income and expense
Other operating income and expense is generated from activities outside of the Group’s normal course of business, which includes Other income from divestments of or full out-license of assets and businesses including royalties and milestones where the Group does not retain a significant continued interest. Where the arrangement meets the definition of a licence agreement, sales milestones and sales royalties are recognised when achieved by applying the royalty exemption under IFRS 15. All other milestones and sales royalties are recognised when it is considered highly probable that there will not be a significant reversal of cumulative income. The determination requires estimates to be made in relation to future Product Sales.
Joint arrangements and associates
The Group has arrangements over which it has joint control and which qualify as joint operations or joint ventures under IFRS 11 ‘Joint Arrangements’. For joint operations, the Group recognises its share of revenue that it earns from the joint operations and its share of expenses incurred. The Group also recognises the assets associated with the joint operations that it controls and the liabilities it incurs under the joint arrangement. For joint ventures and associates, the Group recognises its interest in the joint venture or associate as an investment and uses the equity method of accounting.
Employee benefits
The Group accounts for pensions and other employee benefits (principally healthcare) under IAS 19 ‘Employee Benefits’. In respect of defined benefit plans, obligations are determined using the projected unit credit method and are discounted to present value by reference to market yields on high-quality corporate bonds, while plan assets are measured at fair value. Given the extent of the assumptions used to determine the value of scheme assets and scheme liabilities, these are considered to be significant estimates. The operating and financing costs of such plans are recognised separately in profit; current service costs are spread systematically over the lives of employees and financing costs are recognised in full in the periods in which they arise. Remeasurements of the net defined benefit pension liability, including actuarial gains and losses, are recognised immediately in Other comprehensive income.
Where the calculation results in a surplus to the Group, the recognised asset is limited to the present value of any available future refunds from the plan or reductions in future contributions to the plan subject to consideration of the effect any minimum funding requirement for future service has on the benefit available as a reduction in future contributions.
Payments to defined contribution plans are recognised in profit as they fall due.
Taxation
The current tax payable is based on taxable profit for the year. Taxable profit differs from reported profit because taxable profit excludes items that are either never taxable or tax deductible or items that are taxable or tax deductible in a different period. The Group's current tax assets and liabilities are calculated using tax rates that have been enacted or substantively enacted by the reporting date.
Deferred tax is provided using the balance sheet liability method, providing for temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred tax liabilities are recognised unless they arise from the initial recognition (other than in a business combination) of assets and liabilities in a transaction that affects neither the taxable profit nor the accounting profit. Deferred tax liabilities are not recognised to the extent they arise from the initial recognition of non-tax deductible goodwill. Deferred tax assets are recognised to the extent that there are future taxable temporary differences or it is probable that future taxable profit will be available against which the asset can be utilised. This requires judgements to be made in respect of the availability of future taxable income.
No deferred tax asset or liability is recognised in respect of temporary differences associated with investments in subsidiaries and branches where the Group is able to control the timing of reversal of the temporary differences and it is probable that the temporary differences will not reverse in the foreseeable future.
The Group's deferred tax assets and liabilities are calculated using tax rates that are expected to apply in the period when the liability is settled or the asset realised based on tax rates that have been enacted or substantively enacted by the reporting date. Deferred tax liabilities relating to assets recognised because of a business combination which may qualify for intellectual property incentives are measured at the relevant statutory tax rate. Deferred tax assets and liabilities are offset in the Consolidated Statement of Financial Position if, and only if, the taxable entity has a legally enforceable right to set off current tax assets and liabilities, and the Deferred tax assets and liabilities relate to taxes levied by the same taxation authority on the same taxable entity.
Liabilities for uncertain tax positions require management to make judgements of potential exposures in relation to tax audit issues. Tax benefits are not recognised unless the tax positions will probably be accepted by the tax authorities. This is based upon management's interpretation of applicable laws and regulations and the expectation of how the tax authority will resolve the matter. Once considered probable of not being accepted, management reviews each material tax benefit and reflects the effect of the uncertainty in determining the related taxable result.
Liabilities for uncertain tax positions are measured using either the most likely amount or the expected value amount depending on which method the entity expects to better predict the resolution of the uncertainty.
Further details of the estimates and assumptions made in determining our recorded liability for transfer pricing contingencies and other tax contingencies are included in Note 30 to the Financial Statements from page 204.
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Share-based payments
All plans have been classified as equity settled after assessment. The grant date fair value of the market-based performance elements of employee share plan awards is calculated using a modified Monte Carlo model, with other elements at market price. In accordance with IFRS 2 ‘Share-based Payment’, the resulting cost is recognised in profit on a straight-line basis over the vesting period of the awards. The value of the charge is adjusted to reflect expected and actual levels of awards vesting, except where the failure to vest is as a result of not meeting a market condition. Cancellations of equity instruments are treated as an acceleration of the vesting period and any outstanding charge is recognised in profit immediately.
Cash outflows relating to the vesting of share plans for our employees are recognised within operating activities, as they relate to employee remuneration. The cash flows relating to replacement awards issued to employees as part of the Alexion acquisition (see Note 27 from page 193) are classified within investing activities, as they are part of the aggregate cash flows arising from obtaining control of the subsidiary.
Property, plant and equipment
The Group’s policy is to depreciate the difference between the cost of each item of Property, plant and equipment and its residual value over its estimated useful life on a straight-line basis. Assets under construction are not depreciated until the asset is available for use, at which point the asset is transferred into either Land and buildings or Plant and equipment, and depreciated over its estimated useful economic life.
Reviews are made annually of the estimated remaining lives and residual values of individual productive assets, taking account of commercial and technological obsolescence as well as normal wear and tear. It is impractical to calculate average asset lives exactly. However, the useful economic lives range from approximately 10 to 50 years for buildings, and three to 15 years for plant and equipment. All items of Property, plant and equipment are tested for impairment when there are indications that the carrying value may not be recoverable. Any impairment losses are recognised immediately in Operating profit.
Leases
The Group’s lease arrangements are principally for property, most notably a portfolio of office premises and employee accommodation, and for a global car fleet, utilised primarily by our sales and marketing teams.
The lease liability and corresponding right-of-use asset arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of the following lease payments:
| > | fixed payments, less any lease incentives receivable |
| > | variable lease payments that depend on an index or a rate, initially measured using the index or rate as at the commencement date |
| > | the exercise price of a purchase option if the Group is reasonably certain to exercise that option |
| > | payments of penalties for terminating the lease, if the lease term reflects the Group exercising that option, and |
| > | amounts expected to be payable by the Group under residual value guarantees. |
Right-of-use assets are measured at cost comprising the following:
| > | the amount of the initial measurement of lease liability |
| > | any lease payments made at or before the commencement date less any lease incentives received |
| > | any initial direct costs, and |
| > | restoration costs. |
Judgements made in calculating the lease liability include assessing whether arrangements contain a lease and determining the lease term. Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. Property leases will often include an early termination or extension option to the lease term. Fleet management policies vary by jurisdiction and may include renewal of a lease until a measurement threshold, such as mileage, is reached. Extension and termination options have been considered when determining the lease term, along with all facts and circumstances that may create an economic incentive to exercise an extension option, or not exercise a termination option. Extension periods (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated).
The lease payments are discounted using incremental borrowing rates, as in the majority of leases held by the Group the interest rate implicit in the lease is not readily identifiable. Calculating the discount rate is an estimate made in calculating the lease liability. This rate is the rate that the Group would have to pay to borrow the funds necessary to obtain an asset of similar value to the right-of-use asset in a similar economic environment with similar terms, security and conditions. To determine the incremental borrowing rate, the Group uses a risk-free interest rate adjusted for credit risk, adjusting for terms specific to the lease including term, country and currency.
The Group is exposed to potential future increases in variable lease payments that are based on an index or rate, which are initially measured as at the commencement date, with any future changes in the index or rate excluded from the lease liability until they take effect. When adjustments to lease payments based on an index or rate take effect, the lease liability is reassessed and adjusted against the right-of-use asset.
Lease payments are allocated between principal and finance cost. The finance cost is charged to the Consolidated Statement of Comprehensive Income over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period.
Payments associated with short-term leases of Property, plant and equipment and all leases of low-value assets are recognised on a straight-line basis as an expense in the Consolidated Statement of Comprehensive Income. Short-term leases are leases with a lease term of 12 months or less. Low-value leases are those where the underlying asset value, when new, is $5,000 or less and includes IT equipment and small items of office furniture.
Contracts may contain both lease and non-lease components. The Group allocates the consideration in the contract to the lease and non-lease components based on their relative standalone prices.
Right-of-use assets are generally depreciated over the shorter of the asset's useful life and the lease term on a straight-line basis. If the Group is reasonably certain to exercise a purchase option, the right-of-use asset is depreciated over the underlying asset’s useful life. It is impractical to calculate average asset lives exactly. However, the total lives range from approximately 10 to 50 years for buildings, and three to 15 years for motor vehicles and other assets.
There are no material lease agreements under which the Group is a lessor.
Business combinations and goodwill
In assessing whether an acquired set of assets and activities is a business or an asset, management will first elect whether to apply an optional concentration test to simplify the assessment. Where the concentration test is applied, the acquisition will be treated as the acquisition of an asset if substantially all of the fair value of the gross assets acquired (excluding cash and cash equivalents, deferred tax assets, and related goodwill) is concentrated in a single asset or group of similar identifiable assets.
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Where the concentration test is not applied, or is not met, a further assessment of whether the acquired set of assets and activities is a business will be performed.
The determination of whether an acquired set of assets and activities is a business or an asset can be judgemental, particularly if the target is not producing outputs. Management uses a number of factors to make this determination, which are primarily focused on whether the acquired set of assets and activities include substantive processes that mean the set is capable of being managed for the purpose of providing a return. Key determining factors include the stage of development of any assets acquired, the readiness and ability of the acquired set to produce outputs and the presence of key experienced employees capable of conducting activities required to develop or manufacture the assets. Typically, the specialised nature of many pharmaceutical assets and processes is such that until assets are substantively ready for production and promotion, there are not the required processes for a set of assets and activities to meet the definition of a business in IFRS 3.
On the acquisition of a business, fair values are attributed to the identifiable assets and liabilities. Attributing fair values is a key judgement; refer to Note 27 to the Financial Statements from page 193 for additional details. Contingent liabilities are also recorded at fair value unless the fair value cannot be measured reliably, in which case the value is subsumed into goodwill. Where fair values of acquired contingent liabilities cannot be measured reliably, the assumed contingent liability is not recognised but is disclosed in the same manner as other contingent liabilities.
Where not all of the equity of a subsidiary is acquired, the non-controlling interest is recognised either at fair value or at the non-controlling interest’s proportionate share of the net assets of the subsidiary, on a case-by-case basis. Put options over non-controlling interests are recognised as a financial liability, with a corresponding entry in either Retained earnings or against non-controlling interest reserves on a case-by-case basis.
The timing and amount of future contingent elements of consideration is an estimate. Contingent consideration, which may include development and launch milestones, revenue threshold milestones and revenue-based royalties, is fair valued at the date of acquisition using decision-tree analysis with key inputs including probability of success, consideration of potential delays and revenue projections based on the Group’s internal forecasts. Unsettled amounts of consideration are held at fair value within payables with changes in fair value recognised immediately in profit.
Goodwill is the difference between the fair value of the consideration and the fair value of net assets acquired.
Goodwill arising on acquisitions is capitalised and subject to an impairment review, both annually and when there is an indication that the carrying value may not be recoverable.
The Group’s policy up to and including 1997 was to eliminate Goodwill arising upon acquisitions against reserves. Under IFRS 1 ‘First-time Adoption of International Financial Reporting Standards’ and IFRS 3 ‘Business Combinations’, such Goodwill will remain eliminated against reserves.
Subsidiaries
A subsidiary is an entity controlled, directly or indirectly, by AstraZeneca PLC. Control is regarded as the exposure or rights to the variable returns of the entity when combined with the power to affect those returns. Control is normally evidenced by holding more than 50% of the share capital of the company, however other agreements may be in place that result in control where they give AstraZeneca finance decision-making authority over the relevant activities of the company.
The financial results of subsidiaries are consolidated from the date control is obtained until the date that control ceases.
Inventories
Inventories are stated at the lower of cost and net realisable value. The first in, first out or an average method of valuation is used. For finished goods and work in progress, cost includes directly attributable costs and certain overhead expenses (including depreciation). Selling expenses and certain other overhead expenses (principally central administration costs) are excluded. Net realisable value is determined as estimated selling price less all estimated costs of completion and costs to be incurred in selling and distribution.
Write-downs of inventory occur in the general course of business and are recognised in Cost of sales for launched or approved products and in Research and development expense for products in development.
Assets held for sale
Non-current assets are classified as Assets held for sale when their carrying amount is to be recovered principally through a sale transaction and a sale is considered highly probable. A sale is considered highly probable only when the appropriate level of management has committed to the sale.
Assets held for sale are stated at the lower of carrying amount and fair value less costs to sell. Where there is a partial transfer of a non-current asset to held for sale, an allocation of value is made between the current and non-current portions of the asset based on the relative value of the two portions, unless there is a methodology that better reflects the asset to be disposed of.
Assets held for sale are neither depreciated nor amortised.
Trade and other receivables
Financial assets included in Trade and other receivables are recognised initially at fair value. The Group holds the Trade receivables with the objective to collect the contractual cash flows and therefore measures them subsequently at amortised cost using the effective interest method, less any impairment, based on expected credit losses.
Trade receivables that are subject to debt factoring arrangements are derecognised if they meet the conditions for derecognition detailed in IFRS 9 ‘Financial Instruments’.
Trade and other payables
Financial liabilities included in Trade and other payables are recognised initially at fair value. Subsequent to initial recognition they are measured at amortised cost using the effective interest method. Contingent consideration payables are held at fair value within Level 3 of the fair value hierarchy as defined in Note 12.
Financial instruments
The Group’s financial instruments include Lease liabilities, Trade and other receivables and payables, liabilities for contingent consideration and put options under business combinations, and rights and obligations under employee benefit plans which are dealt with in specific accounting policies.
The Group’s other financial instruments include:
| > | Cash and cash equivalents |
| > | Fixed deposits |
| > | Other investments |
| > | Bank and other borrowings |
| > | Derivatives. |
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Cash and cash equivalents
Cash and cash equivalents comprise cash in hand, current balances with banks and similar institutions, and highly liquid investments with maturities of three months or less when acquired. They are readily convertible into known amounts of cash and are held at amortised cost under the hold to collect classification, where they meet the hold to collect ‘solely payments of principal and interest’ test criteria under IFRS 9. Those not meeting these criteria are held at fair value through profit or loss. Cash and cash equivalents in the Consolidated Statement of Cash Flows include unsecured bank overdrafts at the balance sheet date where balances often fluctuate between a cash and overdraft position.
Fixed deposits
Fixed deposits, principally comprising funds held with banks and other financial institutions, are initially measured at fair value, plus direct transaction costs, and are subsequently measured at amortised cost using the effective interest method at each reporting date. Changes in carrying value are recognised in the Consolidated Statement of Comprehensive Income.
Other investments
Investments are classified as fair value through profit or loss (FVPL), unless the Group makes an irrevocable election at initial recognition for certain non-current equity investments to present changes in Other comprehensive income (FVOCI). If this election is made, there is no subsequent reclassification of fair value gains and losses to profit or loss following the derecognition of the investment.
Bank and other borrowings
The Group uses derivatives, principally interest rate swaps, to hedge the interest rate exposure inherent in a portion of its fixed interest rate debt. In such cases the Group will either designate the debt as FVPL when certain criteria are met or as the hedged item under a fair value hedge.
If the debt instrument is designated as FVPL, the debt is initially measured at fair value (with direct transaction costs being included in profit as an expense) and is remeasured to fair value at each reporting date with changes in carrying value being recognised in profit (along with changes in the fair value of the related derivative), with the exception of changes in the fair value of the debt instrument relating to own credit risk which are recorded in Other comprehensive income in accordance with IFRS 9. Such a designation has been made where this significantly reduces an accounting mismatch which would result from recognising gains and losses on different bases.
If the debt is designated as the hedged item under a fair value hedge, the debt is initially measured at fair value (with direct transaction costs being amortised over the life of the debt) and is remeasured for fair value changes in respect of the hedged risk at each reporting date with changes in carrying value being recognised in profit (along with changes in the fair value of the related derivative).
If the debt is designated in a cash flow hedge, the debt is measured at amortised cost (with gains or losses taken to profit and direct transaction costs being amortised over the life of the debt). The related derivative is remeasured for fair value changes at each reporting date with the portion of the gain or loss on the derivative that is determined to be an effective hedge recognised in Other comprehensive income. The amounts that have been recognised in Other comprehensive income are reclassified to profit in the same period that the hedged forecast cash flows affect profit. The reclassification adjustment is included in Finance expense in the Consolidated Statement of Comprehensive Income.
Other interest-bearing loans are initially measured at fair value (with direct transaction costs being amortised over the life of the loan) and are subsequently measured at amortised cost using the effective interest method at each reporting date. Changes in carrying value are recognised in the Consolidated Statement of Comprehensive Income.
Derivatives
Derivatives are initially measured at fair value (with direct transaction costs being included in profit as an expense) and are subsequently remeasured to fair value at each reporting date. Changes in carrying value of derivatives not designated in hedging relationships are recognised in profit or loss.
The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral, for the benefit of the other, equivalent to the market valuation of all of the derivative positions above a predetermined threshold. Cash collateral received from counterparties is included within current Interest-bearing loans and borrowings within the Consolidated Statement of Financial Position. Cash collateral pledged to counterparties is recognised as a financial asset and is included in current Other investments within the Consolidated Statement of Financial Position. Cash collateral received is included in Movement in short-term borrowings within financing activities in the Consolidated Cash Flow Statement. Cash collateral paid is included in Movements in short-term investments within investing activities in the Consolidated Cash Flow Statement. The cash flow presentation of cash paid and received follows the Consolidated Statement of Financial Position presentation of the financial asset and financial liability that is recognised from posting the collateral.
Foreign currencies
Foreign currency transactions, being transactions denominated in a currency other than an individual Group entity’s functional currency, are translated into the relevant functional currencies of individual Group entities at average rates for the relevant monthly accounting periods, which approximate to actual rates.
Monetary assets and liabilities arising from foreign currency transactions are retranslated at exchange rates prevailing at the reporting date. Exchange gains and losses on loans and on short-term foreign currency borrowings and deposits are included within Finance expense. Exchange differences on all other foreign currency transactions are recognised in Operating profit in the individual Group entity’s accounting records.
Non-monetary items arising from foreign currency transactions are not retranslated in the individual Group entity’s accounting records.
In the Consolidated Financial Statements, income and expense items for Group entities with a functional currency other than US dollars are translated into US dollars at average exchange rates, which approximate to actual rates, for the relevant accounting periods. Assets and liabilities are translated at the US dollar exchange rates prevailing at the reporting date. Exchange differences arising on consolidation are recognised in Other comprehensive income.
If certain criteria are met, non-US dollar-denominated loans or derivatives are designated as net investment hedges of foreign operations. Exchange differences arising on retranslation of net investments, and of foreign currency loans which are designated in an effective net investment hedge relationship, are recognised in Other comprehensive income in the Consolidated Financial Statements. Foreign exchange derivatives hedging net investments in foreign operations are carried at fair value. Effective fair value movements are recognised in Other comprehensive income, with any ineffectiveness taken to profit. Gains and losses accumulated in the translation reserve will be recycled to profit and loss when the foreign operation is sold.
Provisions
Provisions are recognised when there is either a legal or constructive present obligation as a result of a past event, it is probable that an outflow of economic resources will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation. If the effect of the time value of money is material, provisions are discounted at the relevant pre-tax discount rate. Where provisions are discounted, the increase in the provision resulting from the passage of time is recognised as a finance cost.
F-12
Litigation and environmental liabilities
AstraZeneca is involved in legal disputes, the settlement of which may involve cost to the Group. A provision is made where an adverse outcome is probable and associated costs, including related legal costs, can be estimated reliably. Determining the timing of recognition of when an adverse outcome is probable is considered a key judgement, refer to Note 30 to the Financial Statements from page 204.
Where it is considered that the Group is more likely than not to prevail, or in the extremely rare circumstances where the amount of the legal liability cannot be estimated reliably, legal costs involved in defending the claim are charged to the Consolidated Statement of Comprehensive Income as they are incurred.
Where it is considered that the Group has a valid contract which provides the right to reimbursement (from insurance or otherwise) of legal costs and/or all or part of any loss incurred or for which a provision has been established, the amount expected to be received is recognised as an asset only when it is virtually certain.
AstraZeneca is exposed to environmental liabilities relating to its past operations, principally in respect of soil and groundwater remediation costs. Provisions for these costs are made when there is a present obligation and where it is probable that expenditure on remedial work will be required and a reliable estimate can be made of the cost.
Restructuring
Restructuring costs are incurred in programmes that are planned and controlled by the Group which materially change either the scope of a business undertaken by the Group, or the manner in which that business is conducted.
A provision for restructuring costs is recognised when a detailed formal plan is in place and has either been announced to those affected or has started to be implemented. The general recognition criteria for provisions must also be met, as described in the Provisions policy.
Impairment
The carrying values of non-financial assets, other than Inventories and Deferred tax assets, are reviewed at least annually to determine whether there is any indication of impairment. For Goodwill, Intangible assets under development and for any other assets where such indication exists, the asset’s recoverable amount is estimated based on the greater of its value in use and its fair value less cost to sell. In assessing the recoverable amount, the estimated future cash flows, adjusted for the risks associated with the probability of success specific to each asset, as well as inflationary impacts, are discounted to their present value using a nominal discount rate that reflects current market assessments of the time value of money, the general risks affecting the pharmaceutical industry and other risks specific to each asset. For the purpose of impairment testing, assets are grouped together into the smallest group of assets that generates cash inflows from continuing use that are largely independent of the cash flows of other assets. Impairment losses are recognised immediately in the Consolidated Statement of Comprehensive Income.
Applicable accounting standards and interpretations issued but not yet adopted
At the date of authorisation of these financial statements, certain new accounting standards and amendments were in issue relating to the following standards and interpretations but not yet adopted by the Group:
| > | amendments to IAS 1 'Presentation of Financial Statements', effective for periods beginning on or after 1 January 2024 – endorsed by the UK Endorsement Board (UKEB) on 21 July 2023 |
| > | amendments to IFRS 16 ‘Leases’, effective for periods beginning on or after 1 January 2024 – endorsed by the UKEB on 11 May 2023 |
| > | amendments to IAS 7 ‘Statement of Cash Flows’ and IFRS 7 ‘Financial Instruments: Disclosures’, effective for periods beginning on or after 1 January 2024 – endorsed by the UKEB on 28 November 2023 |
| > | amendments to IAS 21 'The Effects of Changes in Foreign Exchange Rates', effective for periods beginning on or after 1 January 2025 – not endorsed by the UKEB. |
These new standards, amendments and interpretations are not expected to have a significant impact on the Group’s net results.
F-13
Notes to the Group Financial Statements
1 Revenue
Product Sales
|
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
2021 |
|
|
|
|
|
Emerging |
|
|
|
Rest of |
|
|
|
|
|
Emerging |
|
|
|
Rest of |
|
|
|
|
|
Emerging |
|
|
|
Rest of |
|
|
|
|
|
US |
|
Markets |
|
Europe |
|
World |
|
Total |
|
US |
|
Markets |
|
Europe |
|
World |
|
Total |
|
US |
|
Markets |
|
Europe |
|
World |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Oncology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso |
|
2,276 |
|
1,621 |
|
1,120 |
|
782 |
|
5,799 |
|
2,007 |
|
1,567 |
|
1,023 |
|
847 |
|
5,444 |
|
1,780 |
|
1,336 |
|
986 |
|
913 |
|
5,015 |
|
Imfinzi |
|
2,317 |
|
360 |
|
758 |
|
802 |
|
4,237 |
|
1,552 |
|
287 |
|
544 |
|
401 |
|
2,784 |
|
1,245 |
|
277 |
|
485 |
|
405 |
|
2,412 |
|
Lynparza |
|
1,254 |
|
542 |
|
734 |
|
281 |
|
2,811 |
|
1,226 |
|
488 |
|
655 |
|
269 |
|
2,638 |
|
1,087 |
|
384 |
|
618 |
|
259 |
|
2,348 |
|
Calquence |
|
1,815 |
|
98 |
|
493 |
|
108 |
|
2,514 |
|
1,657 |
|
45 |
|
286 |
|
69 |
|
2,057 |
|
1,089 |
|
20 |
|
111 |
|
18 |
|
1,238 |
|
Enhertu |
|
– |
|
169 |
|
60 |
|
32 |
|
261 |
|
– |
|
51 |
|
21 |
|
7 |
|
79 |
|
– |
|
12 |
|
4 |
|
1 |
|
17 |
|
Orpathys |
|
– |
|
44 |
|
– |
|
– |
|
44 |
|
– |
|
33 |
|
– |
|
– |
|
33 |
|
– |
|
16 |
|
– |
|
– |
|
16 |
|
Truqap |
|
6 |
|
– |
|
– |
|
– |
|
6 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
Zoladex |
|
14 |
|
687 |
|
133 |
|
118 |
|
952 |
|
15 |
|
657 |
|
133 |
|
122 |
|
927 |
|
13 |
|
619 |
|
147 |
|
169 |
|
948 |
|
Faslodex |
|
31 |
|
142 |
|
28 |
|
96 |
|
297 |
|
17 |
|
159 |
|
55 |
|
103 |
|
334 |
|
30 |
|
167 |
|
113 |
|
121 |
|
431 |
|
Others |
|
6 |
|
165 |
|
6 |
|
47 |
|
224 |
|
10 |
|
250 |
|
9 |
|
66 |
|
335 |
|
11 |
|
391 |
|
17 |
|
96 |
|
515 |
|
|
|
7,719 |
|
3,828 |
|
3,332 |
|
2,266 |
|
17,145 |
|
6,484 |
|
3,537 |
|
2,726 |
|
1,884 |
|
14,631 |
|
5,255 |
|
3,222 |
|
2,481 |
|
1,982 |
|
12,940 |
|
Cardiovascular, Renal & Metabolism: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga |
|
1,451 |
|
2,211 |
|
1,881 |
|
420 |
|
5,963 |
|
1,071 |
|
1,665 |
|
1,297 |
|
348 |
|
4,381 |
|
732 |
|
1,195 |
|
810 |
|
263 |
|
3,000 |
|
Brilinta |
|
744 |
|
285 |
|
271 |
|
24 |
|
1,324 |
|
744 |
|
286 |
|
282 |
|
46 |
|
1,358 |
|
735 |
|
328 |
|
346 |
|
63 |
|
1,472 |
|
Lokelma |
|
214 |
|
50 |
|
58 |
|
90 |
|
412 |
|
170 |
|
20 |
|
30 |
|
69 |
|
289 |
|
115 |
|
3 |
|
13 |
|
44 |
|
175 |
|
roxadustat |
|
– |
|
271 |
|
– |
|
– |
|
271 |
|
– |
|
197 |
|
– |
|
– |
|
197 |
|
– |
|
174 |
|
– |
|
– |
|
174 |
|
Andexxa |
|
75 |
|
– |
|
62 |
|
45 |
|
182 |
|
77 |
|
– |
|
41 |
|
32 |
|
150 |
|
50 |
|
– |
|
18 |
|
– |
|
68 |
|
Crestor |
|
55 |
|
862 |
|
52 |
|
138 |
|
1,107 |
|
65 |
|
794 |
|
41 |
|
148 |
|
1,048 |
|
80 |
|
775 |
|
52 |
|
189 |
|
1,096 |
|
Seloken/Toprol-XL |
|
1 |
|
621 |
|
11 |
|
7 |
|
640 |
|
– |
|
839 |
|
14 |
|
9 |
|
862 |
|
1 |
|
928 |
|
11 |
|
11 |
|
951 |
|
Onglyza |
|
49 |
|
131 |
|
32 |
|
15 |
|
227 |
|
76 |
|
121 |
|
38 |
|
22 |
|
257 |
|
88 |
|
179 |
|
61 |
|
32 |
|
360 |
|
Bydureon |
|
133 |
|
3 |
|
27 |
|
– |
|
163 |
|
242 |
|
3 |
|
35 |
|
– |
|
280 |
|
321 |
|
3 |
|
55 |
|
6 |
|
385 |
|
Others |
|
30 |
|
152 |
|
109 |
|
5 |
|
296 |
|
34 |
|
194 |
|
128 |
|
10 |
|
366 |
|
52 |
|
195 |
|
146 |
|
14 |
|
407 |
|
|
|
2,752 |
|
4,586 |
|
2,503 |
|
744 |
|
10,585 |
|
2,479 |
|
4,119 |
|
1,906 |
|
684 |
|
9,188 |
|
2,174 |
|
3,780 |
|
1,512 |
|
622 |
|
8,088 |
|
Respiratory & Immunology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort |
|
726 |
|
753 |
|
549 |
|
334 |
|
2,362 |
|
973 |
|
608 |
|
582 |
|
375 |
|
2,538 |
|
1,065 |
|
609 |
|
670 |
|
384 |
|
2,728 |
|
Fasenra |
|
992 |
|
64 |
|
355 |
|
142 |
|
1,553 |
|
906 |
|
43 |
|
305 |
|
142 |
|
1,396 |
|
790 |
|
20 |
|
286 |
|
162 |
|
1,258 |
|
Breztri |
|
383 |
|
161 |
|
81 |
|
52 |
|
677 |
|
239 |
|
92 |
|
33 |
|
34 |
|
398 |
|
115 |
|
55 |
|
7 |
|
26 |
|
203 |
|
Saphnelo |
|
260 |
|
2 |
|
8 |
|
10 |
|
280 |
|
111 |
|
– |
|
2 |
|
3 |
|
116 |
|
8 |
|
– |
|
– |
|
– |
|
8 |
|
Tezspire |
|
– |
|
1 |
|
48 |
|
37 |
|
86 |
|
– |
|
– |
|
2 |
|
2 |
|
4 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
Pulmicort |
|
28 |
|
575 |
|
68 |
|
42 |
|
713 |
|
65 |
|
462 |
|
69 |
|
49 |
|
645 |
|
72 |
|
770 |
|
73 |
|
47 |
|
962 |
|
Bevespi |
|
34 |
|
6 |
|
17 |
|
1 |
|
58 |
|
42 |
|
5 |
|
10 |
|
1 |
|
58 |
|
39 |
|
4 |
|
11 |
|
– |
|
54 |
|
Daliresp/Daxas |
|
42 |
|
3 |
|
8 |
|
1 |
|
54 |
|
176 |
|
3 |
|
9 |
|
1 |
|
189 |
|
207 |
|
4 |
|
15 |
|
1 |
|
227 |
|
Others |
|
82 |
|
206 |
|
30 |
|
6 |
|
324 |
|
143 |
|
230 |
|
42 |
|
6 |
|
421 |
|
108 |
|
287 |
|
185 |
|
14 |
|
594 |
|
|
|
2,547 |
|
1,771 |
|
1,164 |
|
625 |
|
6,107 |
|
2,655 |
|
1,443 |
|
1,054 |
|
613 |
|
5,765 |
|
2,404 |
|
1,749 |
|
1,247 |
|
634 |
|
6,034 |
|
Vaccines & Immune Therapies: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 mAbs |
|
– |
|
6 |
|
12 |
|
114 |
|
132 |
|
1,067 |
|
413 |
|
298 |
|
407 |
|
2,185 |
|
– |
|
19 |
|
66 |
|
– |
|
85 |
|
Vaxzevria |
|
– |
|
10 |
|
2 |
|
– |
|
12 |
|
79 |
|
729 |
|
365 |
|
625 |
|
1,798 |
|
64 |
|
2,240 |
|
1,035 |
|
578 |
|
3,917 |
|
Beyfortus |
|
87 |
|
– |
|
19 |
|
– |
|
106 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
Synagis |
|
(1) |
|
195 |
|
175 |
|
177 |
|
546 |
|
1 |
|
173 |
|
213 |
|
191 |
|
578 |
|
23 |
|
35 |
|
203 |
|
149 |
|
410 |
|
FluMist |
|
23 |
|
1 |
|
188 |
|
4 |
|
216 |
|
21 |
|
1 |
|
151 |
|
2 |
|
175 |
|
27 |
|
2 |
|
222 |
|
2 |
|
253 |
|
|
|
109 |
|
212 |
|
396 |
|
295 |
|
1,012 |
|
1,168 |
|
1,316 |
|
1,027 |
|
1,225 |
|
4,736 |
|
114 |
|
2,296 |
|
1,526 |
|
729 |
|
4,665 |
|
Rare Disease: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Soliris |
|
1,734 |
|
424 |
|
670 |
|
317 |
|
3,145 |
|
2,180 |
|
301 |
|
805 |
|
476 |
|
3,762 |
|
1,068 |
|
170 |
|
439 |
|
197 |
|
1,874 |
|
Ultomiris |
|
1,750 |
|
71 |
|
668 |
|
476 |
|
2,965 |
|
1,136 |
|
38 |
|
481 |
|
310 |
|
1,965 |
|
381 |
|
9 |
|
169 |
|
129 |
|
688 |
|
Strensiq |
|
937 |
|
40 |
|
89 |
|
86 |
|
1,152 |
|
769 |
|
35 |
|
78 |
|
76 |
|
958 |
|
297 |
|
10 |
|
36 |
|
35 |
|
378 |
|
Koselugo |
|
195 |
|
59 |
|
53 |
|
24 |
|
331 |
|
162 |
|
26 |
|
20 |
|
– |
|
208 |
|
104 |
|
1 |
|
3 |
|
– |
|
108 |
|
Kanuma |
|
85 |
|
29 |
|
49 |
|
8 |
|
171 |
|
77 |
|
31 |
|
44 |
|
8 |
|
160 |
|
32 |
|
7 |
|
20 |
|
3 |
|
62 |
|
|
|
4,701 |
|
623 |
|
1,529 |
|
911 |
|
7,764 |
|
4,324 |
|
431 |
|
1,428 |
|
870 |
|
7,053 |
|
1,882 |
|
197 |
|
667 |
|
364 |
|
3,110 |
|
Other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium |
|
115 |
|
578 |
|
53 |
|
199 |
|
945 |
|
120 |
|
568 |
|
46 |
|
551 |
|
1,285 |
|
128 |
|
705 |
|
62 |
|
431 |
|
1,326 |
|
Others |
|
18 |
|
153 |
|
52 |
|
8 |
|
231 |
|
24 |
|
220 |
|
77 |
|
19 |
|
340 |
|
43 |
|
212 |
|
109 |
|
14 |
|
378 |
|
|
|
133 |
|
731 |
|
105 |
|
207 |
|
1,176 |
|
144 |
|
788 |
|
123 |
|
570 |
|
1,625 |
|
171 |
|
917 |
|
171 |
|
445 |
|
1,704 |
|
Product Sales |
|
17,961 |
|
11,751 |
|
9,029 |
|
5,048 |
|
43,789 |
|
17,254 |
|
11,634 |
|
8,264 |
|
5,846 |
|
42,998 |
|
12,000 |
|
12,161 |
|
7,604 |
|
4,776 |
|
36,541 |
|
F-14
Rebates and chargebacks in the US
The major market where estimates are seen as significant is the US. When invoicing Product Sales in the US, we estimate the rebates and chargebacks we expect to pay and we consider there to be a significant estimate associated with the rebates for Managed Care, Medicaid and Medicare Part D. The total adjustment in respect of prior year net US Product Sales revenue in 2023 was 1.0% (2022: 1.3%; 2021: 1.5%); this represents the difference between our prior year estimates for rebates and chargebacks against actual amounts paid for the US business. The most significant of these relate to the Medicaid and state programmes with an adjustment in respect of prior year net US Product Sales revenue in 2023 of 0.3% (2022: 0.5%; 2021: 0.4%) and Managed Care and Medicare of 0.5% (2022: 0.8%; 2021: 0.7%).
The adjustment in respect of the prior year net US Product Sales revenue, excluding the Rare Disease therapy area in 2023, was 1.4% (2022: 1.6%; 2021: 1.8%), with Medicaid and state programmes of 0.4% (2022: 0.6%; 2021: 0.5%) and Managed Care and Medicare of 0.7% (2022: 1.1%; 2021: 0.8%).
These values demonstrate the level of sensitivity; further meaningful sensitivity is not able to be provided due to the large volume of variables that contribute to the overall rebates, chargebacks, returns and other revenue accruals. These variables include assumptions in respect of aggregate future sales levels, segment mix and customers' contractual performance, and in addition for Managed Care, US Medicaid and Medicare Part D, the channel inventory levels, and assumptions related to lag time. These assumptions are built up on a product-by-product and customer-by-customer basis, taking into account specific contract provisions coupled with expected performance, and are then aggregated into a weighted average rebate accrual rate for each of our products. Accrual rates are reviewed and adjusted on an as-needed basis. There may be further adjustments when actual rebates are invoiced based on utilisation information submitted to AstraZeneca (in the case of contractual rebates) and claims/invoices are received (in the case of regulatory rebates and chargebacks).
Alliance Revenue
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Enhertu |
|
1,022 |
|
523 |
|
197 |
|
Tezspire |
|
259 |
|
79 |
|
– |
|
Beyfortus |
|
57 |
|
– |
|
– |
|
Vaxzevria: royalties |
|
– |
|
76 |
|
64 |
|
Other royalty income |
|
81 |
|
68 |
|
70 |
|
Other Alliance Revenue |
|
9 |
|
9 |
|
57 |
|
|
|
1,428 |
|
755 |
|
388 |
|
Collaboration Revenue
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Lynparza: regulatory milestones |
|
245 |
|
355 |
|
– |
|
Lynparza: sales milestones |
|
– |
|
– |
|
400 |
|
COVID-19 mAbs: licence fees |
|
180 |
|
– |
|
– |
|
Farxiga: sales milestones |
|
29 |
|
– |
|
– |
|
tralokinumab: sales milestones |
|
20 |
|
110 |
|
– |
|
Beyfortus: regulatory milestones |
|
71 |
|
25 |
|
– |
|
Beyfortus: sales milestones |
|
27 |
|
– |
|
– |
|
Nexium: sale of rights |
|
– |
|
62 |
|
75 |
|
Other Collaboration Revenue |
|
22 |
|
46 |
|
13 |
|
|
|
594 |
|
598 |
|
488 |
|
2 Operating profit
Operating profit includes the following significant items:
Cost of sales
In 2023, Cost of sales includes a charge of $114m (2022: charge of $3,484m) in relation to the release, in line with sales, of fair value uplift to inventory that was recognised under IFRS 3 ‘Business Combinations’ upon the acquisition of Alexion (see Note 27).
During the year, $nil government grants were recognised within Cost of sales (2022: $nil; 2021: $290m). The grants recognised in 2021 related to funding of manufactured Vaxzevria product for the US government, which expired prior to being accepted by the FDA.
Selling, general and administrative expense
In 2023, Selling, general and administrative expense includes a charge of $520m (2022: charge of $182m; 2021: charge of $42m) resulting from changes in the fair value of contingent consideration arising from the acquisition of the diabetes alliance from BMS. These adjustments reflect revised estimates for future sales performance for the products acquired and, as a result, revised estimates for future royalties payable.
In 2023, Selling, general and administrative expense also includes a charge of $1,013m (2022: charge of $789m; 2021: charge of $48m) relating to a number of legal proceedings, including settlements in various jurisdictions in relation to several marketed products (see Note 30).
Research and development expense: Government grants
During the year $74m (2022: $113m; 2021: $531m) of government grants were recognised within Research and development expense. The grants recognised relate to funding for Research and development and related expenses for COVID-19 mAbs of $nil (2022: $112m; 2021: $222m) and Vaxzevria of $74m (2022: $1m; 2021: $309m).
F-15
Other operating income and expense
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Royalty income |
|
107 |
|
59 |
|
62 |
|
Gains on disposal of intangible assets |
|
251 |
|
104 |
|
513 |
|
Gains on disposal of investments in associates and joint ventures |
|
– |
|
– |
|
776 |
|
Net gains/(losses) on disposal of other non-current assets |
|
41 |
|
112 |
|
(4) |
|
Update to the contractual relationships for Beyfortus (nirsevimab) |
|
712 |
|
– |
|
– |
|
Other income1 |
|
393 |
|
439 |
|
453 |
|
Other expense |
|
(164) |
|
(200) |
|
(308) |
|
Other operating income and expense |
|
1,340 |
|
514 |
|
1,492 |
|
| 1 | Other income in 2023 includes $75m of income from Allergan Plc. in respect of the development of brazikumab (2022: $138m; 2021: $99m). |
Gains on disposal of intangible assets in 2023 includes $241m on disposal of commercial rights to Pulmicort Flexhaler to Cheplapharm in the US.
Gains on disposal of intangible assets in 2021 includes $317m on disposal of rights to Crestor in over 30 countries in Europe, except in the UK and Spain.
Net gains/(losses) on disposal of other non-current assets in 2022 includes a $125m gain in respect of the Waltham R&D site sale and leaseback in MA, US (see Note 8).
Gains on disposal of investments in associates and joint ventures in 2021 relates to the disposal of the 26.7% ownership in Viela Bio, as part of the acquisition of Viela Bio by Horizon Therapeutics plc. AstraZeneca received cash proceeds and profit of $776m upon closing, with the profit recorded as Other operating income.
As part of the total consideration received in respect of the agreement to sell US rights to Synagis in 2019, $400m in total has been received related to the rights to participate in the future cash flows from the US profits or losses for Beyfortus (nirsevimab), with $190m cash inflows in 2023 primarily relating to a cash receipt from Sobi following achievement of a regulatory milestone. At 31 December 2022, the full amount of $522m was recognised as a financial liability within non-current Other payables (the Profit Participation Liability) as the Group had not fully transferred the risks and rewards of the underlying cash flows arising from Beyfortus to Sobi. All associated cash flows have been presented within investing activities as the Group has received the cash in exchange for agreeing to transfer future cash flows relating to an intangible asset. In 2023, the contractual relationship between AstraZeneca and Sobi relating to future sales of Beyfortus in the US was replaced by a royalty relationship between Sanofi and Sobi. As a result, the Profit Participation Liability was extinguished and derecognised from the Consolidated Statement of Financial Position, with a gain of $712m recorded in Other operating income and expense. In 2021, as a result of the Probability of Technical/Regulatory Success unwind, an increase of $114m to the Profit Participation Liability was recorded with the cost recorded in Other operating expense.
Restructuring costs
During 2023, the Group has incurred $467m of net restructuring costs, of which $362m resulted from activities that are part of the Post Alexion Acquisition Group Review (PAAGR), bringing the cumulative charges under this programme to $2,067m. Costs in 2023 included $109m within Cost of sales due to the rationalisation of our manufacturing capacity and footprint across certain production sites, $207m within Selling, general and administrative expense in relation to HR, Finance, IT & other integration costs as well as some severance costs, $212m within Research and development expense in relation to the transformation of clinical, regulatory and other R&D data and systems, partially offset by income of $61m in Other operating income and expense generated from the disposal of assets impacted by the restructuring.
In conjunction with the acquisition of Alexion in 2021, the enlarged Group initiated the PAAGR; a global restructuring programme aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments. During 2023, the Group has identified all remaining activities and finalised the scope of the programme. This includes the commencement of work on the planned upgrade of the Group's Enterprise Resource Planning IT systems (Axial Project), which is expected to be substantially complete by the end of 2030. The Group has also continued to progress other legacy restructuring programmes.
Total restructuring costs in 2023 includes an impairment charge to Property, plant and equipment of $7m (2022: reversal of $4m; 2021: charge of $343m), impairment of Right-of-use assets of $13m (2022: $nil; 2021: $nil) and no impairment of Intangible assets (software development costs) (2022: reversal $17m; 2021: charge of $16m).
The tables below show the costs that have been charged in respect of restructuring programmes by cost category and type. Severance provisions are detailed in Note 21.
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Cost of sales |
|
109 |
|
266 |
|
722 |
|
Distribution expense |
|
– |
|
2 |
|
– |
|
Research and development expense |
|
212 |
|
111 |
|
223 |
|
Selling, general and administrative expense |
|
207 |
|
405 |
|
338 |
|
Other operating income and expense |
|
(61) |
|
(67) |
|
– |
|
Total charge |
|
467 |
|
717 |
|
1,283 |
|
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Severance costs |
|
57 |
|
187 |
|
217 |
|
Accelerated depreciation and impairment charges |
|
68 |
|
135 |
|
371 |
|
Other1 |
|
342 |
|
395 |
|
695 |
|
Total charge |
|
467 |
|
717 |
|
1,283 |
|
| 1 | Other costs are those incurred in designing and implementing the Group’s various restructuring initiatives, including costs of integrating systems, structure and processes as part of the PAAGR, costs relating to the Alexion acquisition, internal project costs and external service fees. |
F-16
Financial instruments
Included within Operating profit are the following net gains and losses on financial instruments:
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Gains/(losses) on forward foreign exchange contracts |
|
42 |
|
150 |
|
(21) |
|
Losses on receivables and payables |
|
(260) |
|
(203) |
|
(42) |
|
Total |
|
(218) |
|
(53) |
|
(63) |
|
Impairment charges
Details of impairment charges for 2023, 2022 and 2021 are included in Notes 7, 8 and 10.
3 Finance income and expense
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Finance income |
|
|
|
|
|
|
|
Returns on deposits and equity securities |
|
291 |
|
78 |
|
12 |
|
Fair value gains on debt and interest rate swaps |
|
43 |
|
14 |
|
– |
|
Interest income on income tax balances |
|
10 |
|
3 |
|
31 |
|
Total |
|
344 |
|
95 |
|
43 |
|
Finance expense |
|
|
|
|
|
|
|
Interest on debt, leases and other financing costs |
|
(1,132) |
|
(889) |
|
(774) |
|
Net interest on post-employment defined benefit plan net liabilities (Note 22) |
|
(38) |
|
(29) |
|
(26) |
|
Net exchange losses |
|
(34) |
|
(16) |
|
(20) |
|
Discount unwind on contingent consideration arising from business combinations (Note 20) |
|
(132) |
|
(168) |
|
(226) |
|
Discount unwind on other long-term liabilities1 |
|
(200) |
|
(216) |
|
(248) |
|
Fair value losses on debt and interest rate swaps |
|
(3) |
|
– |
|
(4) |
|
Interest expense on income tax balances |
|
(87) |
|
(28) |
|
(2) |
|
Total |
|
(1,626) |
|
(1,346) |
|
(1,300) |
|
Net finance expense |
|
(1,282) |
|
(1,251) |
|
(1,257) |
|
| 1 | Included within Discount unwind on other long-term liabilities is $55m relating to the Acerta Pharma share purchase liability (2022: $108m; 2021: $161m) and the discount unwind of other payables of $100m (2022: $nil; 2021: $nil) that have arisen from intangible asset additions, see Note 20 for further details. |
There was no interest capitalised during the year.
Financial instruments
Included within finance income and expense are the following net gains and losses on financial instruments:
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Interest and fair value adjustments in respect of debt designated at fair value through profit or loss, net of derivatives |
|
13 |
|
(9) |
|
(5) |
|
Interest and changes in carrying values of debt designated as hedged items in fair value hedges, net of derivatives |
|
– |
|
– |
|
(9) |
|
Interest and fair value changes on fixed and short-term deposits, equity securities, other derivatives and tax balances |
|
177 |
|
54 |
|
16 |
|
Interest on debt, commercial paper, overdrafts and lease liabilities held at amortised cost |
|
(1,004) |
|
(837) |
|
(738) |
|
The interest rate fair value hedges were closed in 2021. Fair value gain or loss of $nil (2022: $nil; 2021: loss of $33m) on interest rate fair value hedging instruments and $nil fair value gain or loss (2022: $nil; 2021: gain of $29m) on the related hedged items have been included within Interest and changes in carrying values of debt designated as hedged items in fair value hedges, net of derivatives.
Fair value loss of $1m (2022: loss of $25m; 2021: loss of $19m) on derivatives related to debt instruments designated at FVPL and $7m fair value gain (2022: gain of $26m; 2021: gain of $19m) on debt instruments designated at FVPL have been included within Interest and fair value adjustments in respect of debt designated at fair value through profit or loss, net of derivatives.
4 Taxation
Taxation charge/(credit) recognised in the Consolidated Statement of Comprehensive Income is as follows:
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Current tax |
|
|
|
|
|
|
|
Current year |
|
2,417 |
|
1,823 |
|
1,200 |
|
Adjustment to prior years |
|
28 |
|
(187) |
|
(5) |
|
Total |
|
2,445 |
|
1,636 |
|
1,195 |
|
Deferred tax |
|
|
|
|
|
|
|
Origination and reversal of temporary differences |
|
(1,473) |
|
(2,563) |
|
(1,417) |
|
Adjustment to prior years |
|
(34) |
|
135 |
|
(158) |
|
Total |
|
(1,507) |
|
(2,428) |
|
(1,575) |
|
Taxation charge/(credit) recognised in the profit for the year |
|
938 |
|
(792) |
|
(380) |
|
F-17
Taxation credit/(charge) recognised in Other comprehensive income is as follows:
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Current and deferred tax |
|
|
|
|
|
|
|
Items that will not be reclassified to profit or loss: |
|
|
|
|
|
|
|
Remeasurement of the defined benefit liability |
|
102 |
|
(231) |
|
(117) |
|
Equity investments measured at fair value through Other comprehensive income |
|
(1) |
|
15 |
|
27 |
|
Movement in deferred taxes relating to changes in tax rates |
|
– |
|
– |
|
195 |
|
Total |
|
101 |
|
(216) |
|
105 |
|
Items that may be reclassified subsequently to profit or loss: |
|
|
|
|
|
|
|
Foreign exchange arising on designated liabilities in net investment hedges |
|
(24) |
|
73 |
|
43 |
|
Fair value movement on cash flow hedges |
|
12 |
|
– |
|
(5) |
|
Movement in deferred taxes relating to changes in tax rates |
|
– |
|
– |
|
8 |
|
Total |
|
(12) |
|
73 |
|
46 |
|
Taxation credit/(charge) recognised in Other comprehensive income |
|
89 |
|
(143) |
|
151 |
|
The reported tax rate in the year was 14% and included a favourable adjustment of $828m to deferred taxes arising from a UK group company undertaking a routine intragroup purchase of certain intellectual property. This intragroup purchase resulted in additional amortisable tax basis in the UK which can be fully utilised against forecast UK taxable profits. Deferred tax has been recognised on this additional tax basis in the year. This is offset by updates to tax liabilities following progress of reviews by tax authorities and administrative appeal processes and derecognition of deferred tax assets following changes to forecast taxable income of specific subsidiaries.
The income tax paid for the year was $2,366m.
Taxation has been provided at current rates on the profits earned for the years covered by the Group Financial Statements. The 2023 prior year current tax adjustment relates mainly to tax accrual to tax return adjustments and updates to provisions for tax contingencies. The 2022 prior year current tax adjustment relates mainly to tax accrual to tax return adjustments and updates to provisions for tax contingencies. The 2021 prior year current tax adjustment relates mainly to tax accrual to tax return adjustments.
The 2023 prior year deferred tax adjustment relates mainly to tax accrual to tax return adjustments and adjustments to the recognition of deferred tax assets. The 2022 prior year deferred tax adjustments relate mainly to tax accrual to tax return adjustments and updates to provisions for tax contingencies. The 2021 prior year deferred tax adjustments relate mainly to tax accrual to tax return adjustments and updates to estimates of prior year tax liabilities following settlements with tax authorities.
To the extent that dividends remitted from overseas subsidiaries, joint ventures and associates are expected to result in additional taxes, appropriate amounts have been provided for. Unremitted earnings or differences in the carrying value and tax basis of investments may be liable to additional taxes if distributed as dividends or on a liquidation event. Deferred tax is provided for such differences in relation to Group entities where management is intending to remit earnings in the foreseeable future. The aggregate amount of gross temporary differences associated with investments in subsidiaries, partnerships and branches for which deferred tax liabilities have not been recognised totalled approximately $7,565m at 31 December 2023, $3,221m of which has a corresponding deductible temporary difference of the same gross value which is not recognised as it is not probable of reversing in the foreseeable future but on which different tax rates apply.
Factors affecting future tax charges
As a group with worldwide operations, AstraZeneca is subject to several factors that may affect future tax charges, principally the levels and mix of profitability in different jurisdictions, transfer pricing regulations, tax rates imposed and tax regime reforms. On 11 July 2023, Finance (No.2) Act 2023 was enacted in the UK, introducing a global minimum effective tax rate of 15%. The legislation implements a domestic top-up tax and a multinational top-up tax, effective for accounting periods starting on or after 31 December 2023. A Pillar 2 Effective Tax Rate (ETR) is calculated for every jurisdiction in which the Group operates and Pillar 2 Income Taxes will arise when the Pillar 2 ETR is less than 15%. Pillar 2 Income Taxes could be payable in the UK, or the local jurisdiction if it has introduced a Qualifying Domestic Minimum top-up Tax. AstraZeneca is continuing to monitor potential impacts as further guidance is published by the OECD and territories implement legislation to enact the rules. Management has performed an assessment of the impact of the UK’s Pillar 2 rules based on our 2023 data and no Pillar 2 Income Taxes are expected to arise for most jurisdictions in which the Group operates. It is anticipated that AstraZeneca may, in some jurisdictions, incur additional tax liabilities, but the effect on the reported tax charge is reasonably estimated to be immaterial.
The Group has applied the exemption under the IAS 12 ‘Income Taxes’ amendment for recognising and disclosing information about deferred tax assets and liabilities related to top-up income taxes.
Tax reconciliation to UK statutory rate
The table below reconciles the UK statutory tax charge to the Group’s total tax charge/(credit):
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Profit/(loss) before tax |
|
6,899 |
|
2,501 |
|
(265) |
|
Notional taxation charge at UK corporation tax rate of 23.5% (2022: 19%; 2021: 19%) |
|
1,621 |
|
475 |
|
(50) |
|
Differences in effective overseas tax rates1 |
|
(224) |
|
(59) |
|
1 |
|
Deferred tax (credit)/charge relating to change in tax rates2 |
|
(66) |
|
(108) |
|
54 |
|
Unrecognised deferred tax asset3 |
|
341 |
|
68 |
|
32 |
|
Items not deductible for tax purposes |
|
46 |
|
90 |
|
208 |
|
Items not chargeable for tax purposes |
|
– |
|
– |
|
(163) |
|
Intellectual Property incentive regimes4 |
|
(367) |
|
(265) |
|
– |
|
Other items5 |
|
(406) |
|
(941) |
|
(299) |
|
Adjustments in respect of prior years6 |
|
(7) |
|
(52) |
|
(163) |
|
Total tax charge/(credit) for the year |
|
938 |
|
(792) |
|
(380) |
|
| 1 | Includes the impact of the reversal of a $1.9bn deferred tax liability that was recognised in a previous business combination (31 December 2023: $0.9bn) and originated in goodwill. Some of this liability reverses in an innovation incentive regime and gives rise to a post-acquisition benefit to the tax charge that is not material year-on-year. Determining the cumulative post-acquisition benefit over the life of the asset involves estimates and judgements as the amount of income that qualifies for the IP incentive regime varies. The actual tax rates applied over the life of the asset are expected to be a blend between the Dutch statutory tax rate and intellectual property incentive regime rate. |
F-18
AstraZeneca is domiciled in the UK but operates in other countries where the tax rates and laws are different to those in the UK. The impact on differences in effective overseas tax rates on the Group’s overall tax charge is noted above. Profits arising from our manufacturing operation in Puerto Rico are granted special status and are taxed at a reduced rate compared with the normal rate of tax in that territory under a tax incentive grant continuing until 2031. The Group receives intellectual property incentives in certain jurisdictions, resulting in a reduction to the tax charge in the income statement of $367m in 2023.
Deferred tax
The total movement in the net deferred tax balance in the year was $1,555m. The movements are as follows:
|
|
Intangibles, |
|
Pension and |
|
Elimination of |
|
|
|
Losses and |
|
|
|
|
|
|
|
|
|
Property, plant |
|
post-retirement |
|
unrealised profit |
|
Untaxed |
|
tax credits |
|
Accrued |
|
|
|
|
|
|
|
and equipment |
1 |
benefits |
|
on inventory |
|
reserves |
2 |
carried forward |
|
expenses |
|
Other |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Net deferred tax balance at 1 January 2021 |
|
(2,627) |
|
656 |
|
1,807 |
|
(801) |
|
714 |
|
660 |
|
111 |
|
520 |
|
Income statement |
|
782 |
|
(166) |
|
(59) |
|
(139) |
|
307 |
|
697 |
|
153 |
|
1,575 |
|
Other comprehensive income |
|
52 |
|
83 |
|
– |
|
– |
|
– |
|
– |
|
40 |
|
175 |
|
Equity |
|
– |
|
– |
|
– |
|
– |
|
– |
|
4 |
|
10 |
|
14 |
|
Additions through business combinations3 |
|
(3,744) |
|
13 |
|
166 |
|
– |
|
507 |
|
(1,263) |
|
147 |
|
(4,174) |
|
Exchange |
|
57 |
|
(33) |
|
(53) |
|
78 |
|
(10) |
|
(13) |
|
(12) |
|
14 |
|
Net deferred tax balance at 31 December 2021 |
|
(5,480) |
|
553 |
|
1,861 |
|
(862) |
|
1,518 |
|
85 |
|
449 |
|
(1,876) |
|
Income statement4 |
|
1,414 |
|
(55) |
|
274 |
|
38 |
|
(126) |
|
778 |
|
105 |
|
2,428 |
|
Other comprehensive income |
|
72 |
|
(231) |
|
– |
|
– |
|
– |
|
– |
|
16 |
|
(143) |
|
Equity |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
38 |
|
38 |
|
Exchange |
|
63 |
|
(36) |
|
(111) |
|
108 |
|
(134) |
|
17 |
|
(35) |
|
(128) |
|
Net deferred tax balance at 31 December 2022 |
|
(3,931) |
|
231 |
|
2,024 |
|
(716) |
|
1,258 |
|
880 |
|
573 |
|
319 |
|
Income statement4 |
|
1,518 |
|
(69) |
|
426 |
|
96 |
|
(308) |
|
(23) |
|
(133) |
|
1,507 |
|
Other comprehensive income |
|
(16) |
|
106 |
|
– |
|
– |
|
– |
|
– |
|
(23) |
|
67 |
|
Equity |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(21) |
|
(21) |
|
Additions |
|
(24) |
|
– |
|
– |
|
– |
|
50 |
|
– |
|
(1) |
|
25 |
|
Exchange |
|
(38) |
|
15 |
|
(64) |
|
(40) |
|
106 |
|
32 |
|
(34) |
|
(23) |
|
Net deferred tax balance at 31 December 2023⁵ |
|
(2,491) |
|
283 |
|
2,386 |
|
(660) |
|
1,106 |
|
889 |
|
361 |
|
1,874 |
|
| 1 | Includes deferred tax assets of $507m on liabilities in respect of intangibles and $188m on lease liabilities in respect of right-of-use assets. |
The net deferred tax balance, before the offset of balances within countries, consists of:
|
|
Intangibles, |
|
Pension and |
|
Elimination of |
|
|
|
Losses and |
|
|
|
|
|
|
|
|
|
Property, plant |
|
post-retirement |
|
unrealised profit |
|
Untaxed |
|
tax credits |
|
Accrued |
|
|
|
|
|
|
|
and equipment |
|
benefits |
|
on inventory |
|
reserves |
|
carried forward |
|
expenses |
|
Other |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Deferred tax assets at 31 December 2021 |
|
1,476 |
|
574 |
|
1,910 |
|
– |
|
1,571 |
|
1,117 |
|
618 |
|
7,266 |
|
Deferred tax liabilities at 31 December 2021 |
|
(6,956) |
|
(21) |
|
(49) |
|
(862) |
|
(53) |
|
(1,032) |
|
(169) |
|
(9,142) |
|
Net deferred tax balance at 31 December 2021 |
|
(5,480) |
|
553 |
|
1,861 |
|
(862) |
|
1,518 |
|
85 |
|
449 |
|
(1,876) |
|
Deferred tax assets at 31 December 2022 |
|
1,499 |
|
276 |
|
2,048 |
|
– |
|
1,274 |
|
1,005 |
|
609 |
|
6,711 |
|
Deferred tax liabilities at 31 December 2022 |
|
(5,430) |
|
(45) |
|
(24) |
|
(716) |
|
(16) |
|
(125) |
|
(36) |
|
(6,392) |
|
Net deferred tax balance at 31 December 2022 |
|
(3,931) |
|
231 |
|
2,024 |
|
(716) |
|
1,258 |
|
880 |
|
573 |
|
319 |
|
Deferred tax assets at 31 December 2023 |
|
1,883 |
|
313 |
|
2,386 |
|
– |
|
1,141 |
|
1,011 |
|
488 |
|
7,222 |
|
Deferred tax liabilities at 31 December 2023 |
|
(4,374) |
|
(30) |
|
– |
|
(660) |
|
(35) |
|
(122) |
|
(127) |
|
(5,348) |
|
Net deferred tax balance at 31 December 2023 |
|
(2,491) |
|
283 |
|
2,386 |
|
(660) |
|
1,106 |
|
889 |
|
361 |
|
1,874 |
|
F-19
Analysed in the Consolidated Statement of Financial Position, after offset of balances within countries, as follows:
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Deferred tax assets |
|
4,718 |
|
3,263 |
|
4,330 |
|
Deferred tax liabilities |
|
(2,844) |
|
(2,944) |
|
(6,206) |
|
Net deferred tax balance |
|
1,874 |
|
319 |
|
(1,876) |
|
Unrecognised deferred tax assets
Deferred tax assets (DTA) of $1,251m (2022: $807m; 2021: $719m) have not been recognised in respect of deductible temporary differences because it is not probable that future taxable profit will be available against which the Group can utilise the benefits therefrom.
|
|
2023 |
|
2023 |
|
2022 |
|
2022 |
|
2021 |
|
2021 |
|
|
|
Temporary |
|
Unrecognised |
|
Temporary |
|
Unrecognised |
|
Temporary |
|
Unrecognised |
|
|
|
differences |
|
DTA |
|
differences |
|
DTA |
|
differences |
|
DTA |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Temporary differences expiring: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Within 10 years |
|
87 |
|
22 |
|
104 |
|
26 |
|
4 |
|
1 |
|
More than 10 years |
|
153 |
|
32 |
|
153 |
|
32 |
|
53 |
|
11 |
|
Indefinite |
|
2,788 |
|
595 |
|
686 |
|
163 |
|
300 |
|
79 |
|
|
|
3,028 |
|
649 |
|
943 |
|
221 |
|
357 |
|
91 |
|
Tax credits and State tax losses expiring: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Within 10 years |
|
|
|
152 |
|
|
|
115 |
|
|
|
101 |
|
More than 10 years |
|
|
|
363 |
|
|
|
384 |
|
|
|
441 |
|
Indefinite |
|
|
|
87 |
|
|
|
87 |
|
|
|
86 |
|
|
|
|
|
602 |
|
|
|
586 |
|
|
|
628 |
|
Total |
|
|
|
1,251 |
|
|
|
807 |
|
|
|
719 |
|
5 Earnings per $0.25 Ordinary Share
|
|
|
2023 |
|
|
2022 |
|
|
2021 |
|
Profit for the year attributable to equity holders ($m) |
|
|
5,955 |
|
|
3,288 |
|
|
112 |
|
Basic earnings per Ordinary Share |
|
|
$3.84 |
|
|
$2.12 |
|
|
$0.08 |
|
Diluted earnings per Ordinary Share |
|
|
$3.81 |
|
|
$2.11 |
|
|
$0.08 |
|
Weighted average number of Ordinary Shares in issue for basic earnings (millions) |
|
|
1,549 |
|
|
1,548 |
|
|
1,418 |
|
Dilutive impact of share options outstanding (millions) |
|
|
13 |
|
|
12 |
|
|
9 |
|
Diluted weighted average number of Ordinary Shares in issue (millions) |
|
|
1,562 |
|
|
1,560 |
|
|
1,427 |
|
The earnings figures used in the calculations above are post-tax. The weighted average number of Ordinary Shares in issue is calculated by taking the number of Ordinary Shares outstanding each day weighted by the number of days that those shares were outstanding.
6 Segment information
The Group has reviewed its assessment of reportable segments under IFRS 8 ‘Operating Segments’ and concluded that the Group continues to have one reportable segment.
This determination is considered to be a Key Judgement and this judgement has been taken with reference to the following factors:
1 The level of integration across the different functions of the Group’s pharmaceutical business:
AstraZeneca is engaged in a single business activity of pharmaceuticals and the Group does not have multiple operating segments. AstraZeneca’s pharmaceuticals business consists of the discovery and development of new products, which are then manufactured, marketed and sold. All of these functional activities take place (and are managed) globally on a highly integrated basis. These individual functional areas are not managed separately.
2 The identification of the Chief Operating Decision Maker (CODM) and the nature and extent of the financial information reviewed by the CODM:
The SET, established and chaired by the CEO, is the vehicle through which the CEO exercises the authority delegated to him from the Board for the management, development and performance of AstraZeneca as a whole. It is considered that the SET is AstraZeneca’s Chief Operating Decision Making body (as defined by IFRS 8). The operation of the SET is principally driven by the management of the Commercial operations, R&D, manufacturing and supply and enabling functions. All significant operating decisions are undertaken by the SET. While members of the SET have responsibility for implementation of decisions in their respective areas, operating decision making is at SET level as a whole. Where necessary, these are implemented through cross-functional sub-committees that consider the Group-wide impact of a new decision. For example, product launch decisions would be initially considered by the SET and, on approval, passed to an appropriate sub team for implementation. The ability of the enterprise to develop, produce, deliver and commercialise a wide range of pharmaceutical products are central to the SET decision-making process.
In assessing performance, the SET reviews financial information on an integrated basis for the Group as a whole, substantially in the form of, and on the same basis as, the Group’s IFRS Financial Statements. The high upfront cost of discovering and developing new products, coupled with the relatively insignificant and stable unit cost of production, means that there is not the clear link that exists in many manufacturing businesses between the revenue generated on an individual product sale and the associated cost and hence margin generated on a product. Consequently, the profitability of individual drugs or classes of drugs is not considered a key measure of performance for the business and is not monitored by the SET. The focus of additional financial information reviewed is at brand sales and Gross Margin level within specific geographies. Expenditure analysis is completed for the science units, operations and enabling functions; there is no allocation of these centrally managed Group costs to the individual product or brands. The bonus of SET members’ continues to be derived from the Group scorecard outcome as discussed in our Directors’ Remuneration Report.
F-20
3 How resources are allocated:
Resources are allocated on a Group-wide basis according to need. In particular, capital expenditure, in-licensing, and R&D resources are allocated between activities on merit, based on overall therapeutic considerations and strategy under the aegis of the Group’s Early-Stage Product Committees and Late-Stage Product Committees.
Geographic areas
The following table shows information for Total Revenue by geographic area and material countries. The additional tables show the Operating profit and Profit before tax made by companies located in that area, together with Non-current assets, Total assets, Assets acquired, Net operating assets, and Property, plant and equipment owned by the same companies. Product Sales by geographic market are included in the area/country where the legal entity resides and from which those sales were made.
|
|
|
|
|
|
Total Revenue |
|
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
UK |
|
3,368 |
|
3,117 |
|
3,245 |
|
|
|
|
|
|
|
|
|
Rest of Europe |
|
|
|
|
|
|
|
France |
|
1,152 |
|
1,107 |
|
915 |
|
Germany |
|
2,099 |
|
1,902 |
|
1,486 |
|
Italy |
|
813 |
|
735 |
|
577 |
|
Spain |
|
847 |
|
738 |
|
578 |
|
Sweden |
|
1,704 |
|
1,721 |
|
2,322 |
|
Others |
|
3,110 |
|
2,706 |
|
1,949 |
|
|
|
9,725 |
|
8,909 |
|
7,827 |
|
The Americas |
|
|
|
|
|
|
|
Canada |
|
967 |
|
1,166 |
|
772 |
|
US |
|
18,121 |
|
17,278 |
|
12,047 |
|
Others |
|
1,683 |
|
1,175 |
|
1,203 |
|
|
|
20,771 |
|
19,619 |
|
14,022 |
|
Asia, Africa & Australasia |
|
|
|
|
|
|
|
Australia |
|
390 |
|
571 |
|
547 |
|
China |
|
5,872 |
|
5,743 |
|
6,002 |
|
Japan |
|
3,640 |
|
3,986 |
|
3,395 |
|
Others |
|
2,045 |
|
2,406 |
|
2,379 |
|
|
|
11,947 |
|
12,706 |
|
12,323 |
|
Total Revenue |
|
45,811 |
|
44,351 |
|
37,417 |
|
Total Revenue outside of the UK totalled $42,443m for the year ended 31 December 2023 (2022: $41,234m; 2021: $34,172m).
|
|
|
|
Operating profit/(loss) |
|
|
|
Profit/(loss) before tax |
|
||||
|
|
2023 |
|
2022 |
|
2021 |
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
UK |
|
665 |
|
1,120 |
|
(950) |
|
(577) |
|
272 |
|
(1,477) |
|
Rest of Europe |
|
4,885 |
|
2,945 |
|
2,999 |
|
4,999 |
|
2,709 |
|
2,682 |
|
The Americas |
|
1,495 |
|
(954) |
|
(1,936) |
|
1,328 |
|
(1,140) |
|
(2,401) |
|
Asia, Africa & Australasia |
|
1,148 |
|
646 |
|
943 |
|
1,149 |
|
660 |
|
931 |
|
Continuing operations |
|
8,193 |
|
3,757 |
|
1,056 |
|
6,899 |
|
2,501 |
|
(265) |
|
|
|
|
|
Non-current assets |
1, 2 |
|
|
|
|
Total assets |
|
||
|
|
2023 |
|
2022 |
|
2021 |
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
UK |
|
8,626 |
|
8,208 |
|
7,310 |
|
19,616 |
|
16,786 |
|
16,615 |
|
Rest of Europe |
|
32,905 |
|
34,301 |
|
38,286 |
|
40,638 |
|
40,669 |
|
48,383 |
|
The Americas |
|
26,524 |
|
25,425 |
|
26,333 |
|
34,754 |
|
32,990 |
|
34,301 |
|
Asia, Africa & Australasia |
|
910 |
|
929 |
|
1,078 |
|
6,111 |
|
6,038 |
|
6,064 |
|
Continuing operations |
|
68,965 |
|
68,863 |
|
73,007 |
|
101,119 |
|
96,483 |
|
105,363 |
|
|
|
|
|
|
|
Assets acquired |
3 |
|
|
Net operating assets |
4 |
||
|
|
2023 |
|
2022 |
|
2021 |
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
UK |
|
812 |
|
2,301 |
|
810 |
|
5,275 |
|
3,863 |
|
3,239 |
|
Rest of Europe |
|
1,770 |
|
522 |
|
26,527 |
|
32,920 |
|
32,726 |
|
40,161 |
|
The Americas |
|
1,925 |
|
421 |
|
10,810 |
|
22,746 |
|
23,290 |
|
24,786 |
|
Asia, Africa & Australasia |
|
117 |
|
51 |
|
94 |
|
1,405 |
|
1,895 |
|
736 |
|
Continuing operations |
|
4,624 |
|
3,295 |
|
38,241 |
|
62,346 |
|
61,774 |
|
68,922 |
|
| 1 | Non-current assets exclude Deferred tax assets and Derivative financial instruments. |
| 2 | The Group has revised the presentation of Non-current assets to exclude certain financial assets and post-employment benefit assets which previously had been included in this disclosure. This resulted in a decrease in 2022 of $1,690m and in 2021 of $1,680m. |
| 3 | Included in Assets acquired are those assets that are expected to be used during more than one period (Property, plant and equipment, Goodwill and Intangible assets) and include those acquired through business combinations (Note 27). |
| 4 | Net operating assets exclude short-term investments, cash, short-term borrowings, loans, Derivative financial instruments, Retirement benefit obligations and non-operating receivables and payables. |
F-21
|
|
|
|
Property, plant and equipment |
|
||
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
UK |
|
2,831 |
|
2,526 |
|
2,542 |
|
Ireland |
|
1,164 |
|
1,040 |
|
969 |
|
Sweden |
|
1,678 |
|
1,472 |
|
1,593 |
|
US |
|
2,371 |
|
2,176 |
|
2,660 |
|
Rest of the world |
|
1,358 |
|
1,293 |
|
1,419 |
|
Continuing operations |
|
9,402 |
|
8,507 |
|
9,183 |
|
Geographic markets
The table below shows Product Sales in each geographic market in which customers are located.
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
UK |
|
978 |
|
996 |
|
1,206 |
|
Rest of Europe |
|
8,201 |
|
7,503 |
|
6,792 |
|
The Americas |
|
20,855 |
|
20,126 |
|
14,893 |
|
Asia, Africa & Australasia |
|
13,755 |
|
14,373 |
|
13,650 |
|
Continuing operations |
|
43,789 |
|
42,998 |
|
36,541 |
|
Product Sales are recognised when control of the goods has been transferred to a third party. A significant proportion of this is upon delivery of the products to wholesalers. One wholesaler (2022: one; 2021: one) individually represented greater than 10% of Product Sales. The value of Product Sales to this wholesaler was $6,513m (2022: $5,387m; 2021: $4,862m).
F-22
7 Property, plant and equipment
|
|
|
|
|
|
Assets in |
|
Total Property, |
|
|
|
Land and |
|
Plant and |
|
course of |
|
plant and |
|
|
|
buildings |
|
equipment |
|
construction |
|
equipment |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
Cost |
|
|
|
|
|
|
|
|
|
At 1 January 2021 |
|
5,851 |
|
7,738 |
|
2,478 |
|
16,067 |
|
Additions through business combinations (Note 27) |
|
542 |
|
339 |
|
254 |
|
1,135 |
|
Capital expenditure |
|
9 |
|
31 |
|
1,112 |
|
1,152 |
|
Transfer of assets into use |
|
236 |
|
611 |
|
(847) |
|
– |
|
Disposals and other movements |
|
(92) |
|
(469) |
|
(200) |
|
(761) |
|
Exchange adjustments |
|
(169) |
|
(347) |
|
(69) |
|
(585) |
|
At 31 December 2021 |
|
6,377 |
|
7,903 |
|
2,728 |
|
17,008 |
|
Capital expenditure |
|
5 |
|
19 |
|
1,042 |
|
1,066 |
|
Transfer of assets into use |
|
226 |
|
683 |
|
(909) |
|
– |
|
Transfer of Assets held for sale (Note 18) |
|
(434) |
|
(293) |
|
– |
|
(727) |
|
Disposals and other movements |
|
(425) |
|
(146) |
|
28 |
|
(543) |
|
Exchange adjustments |
|
(309) |
|
(610) |
|
(236) |
|
(1,155) |
|
At 31 December 2022 |
|
5,440 |
|
7,556 |
|
2,653 |
|
15,649 |
|
Additions through business combinations (Note 27) |
|
2 |
|
10 |
|
– |
|
12 |
|
Capital expenditure |
|
9 |
|
43 |
|
1,402 |
|
1,454 |
|
Transfer of assets into use |
|
959 |
|
1,158 |
|
(2,117) |
|
– |
|
Disposals and other movements |
|
(6) |
|
(255) |
|
(11) |
|
(272) |
|
Exchange adjustments |
|
65 |
|
192 |
|
118 |
|
375 |
|
At 31 December 2023 |
|
6,469 |
|
8,704 |
|
2,045 |
|
17,218 |
|
Depreciation and impairment |
|
|
|
|
|
|
|
|
|
At 1 January 2021 |
|
2,826 |
|
4,990 |
|
– |
|
7,816 |
|
Depreciation charge for the year |
|
231 |
|
493 |
|
– |
|
724 |
|
Impairment (reversal)/charge |
|
(1) |
|
121 |
|
223 |
|
343 |
|
Disposals and other movements |
|
(74) |
|
(428) |
|
(223) |
|
(725) |
|
Exchange adjustments |
|
(105) |
|
(228) |
|
– |
|
(333) |
|
At 31 December 2021 |
|
2,877 |
|
4,948 |
|
– |
|
7,825 |
|
Depreciation charge for the year |
|
286 |
|
566 |
|
– |
|
852 |
|
Impairment charge/(reversal) |
|
20 |
|
8 |
|
(28) |
|
– |
|
Transferred to Assets held for sale (Note 18) |
|
(300) |
|
(277) |
|
– |
|
(577) |
|
Disposals and other movements |
|
(227) |
|
(188) |
|
28 |
|
(387) |
|
Exchange adjustments |
|
(167) |
|
(404) |
|
– |
|
(571) |
|
At 31 December 2022 |
|
2,489 |
|
4,653 |
|
– |
|
7,142 |
|
Depreciation charge for the year |
|
241 |
|
492 |
|
– |
|
733 |
|
Impairment charge |
|
4 |
|
4 |
|
– |
|
8 |
|
Disposals and other movements |
|
(13) |
|
(220) |
|
– |
|
(233) |
|
Exchange adjustments |
|
44 |
|
122 |
|
– |
|
166 |
|
At 31 December 2023 |
|
2,765 |
|
5,051 |
|
– |
|
7,816 |
|
Net book value |
|
|
|
|
|
|
|
|
|
At 31 December 2021 |
|
3,500 |
|
2,955 |
|
2,728 |
|
9,183 |
|
At 31 December 2022 |
|
2,951 |
|
2,903 |
|
2,653 |
|
8,507 |
|
At 31 December 2023 |
|
3,704 |
|
3,653 |
|
2,045 |
|
9,402 |
|
Impairment charges in 2021 totalling $343m were recognised for Plant and equipment and Assets in course of construction due to the rationalisation of our manufacturing capacity and footprint across certain production sites as a result of restructuring programmes, including the PAAGR (see Note 2). These charges were recognised in Cost of sales. The revised carrying value of the impacted assets is $nil, under fair value less costs to sell.
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
The net book value of land and buildings comprised: |
|
|
|
|
|
|
|
Freeholds |
|
2,976 |
|
2,555 |
|
2,985 |
|
Leaseholds |
|
728 |
|
396 |
|
515 |
|
F-23
8 Leases
Right-of-use assets
|
|
|
|
|
|
|
|
Total |
|
|
|
Land and |
|
Motor |
|
|
|
Right-of-use |
|
|
|
buildings |
|
vehicles |
|
Other |
|
assets |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
Cost |
|
|
|
|
|
|
|
|
|
At 1 January 2021 |
|
735 |
|
272 |
|
36 |
|
1,043 |
|
Additions through business combinations (Note 27) |
|
255 |
|
8 |
|
– |
|
263 |
|
Additions – separately acquired |
|
145 |
|
98 |
|
2 |
|
245 |
|
Disposals and other movements |
|
25 |
|
(44) |
|
(4) |
|
(23) |
|
Exchange adjustments |
|
(27) |
|
(13) |
|
(1) |
|
(41) |
|
At 31 December 2021 |
|
1,133 |
|
321 |
|
33 |
|
1,487 |
|
Additions through business combinations (Note 27) |
|
4 |
|
– |
|
– |
|
4 |
|
Additions – separately acquired |
|
140 |
|
81 |
|
14 |
|
235 |
|
Disposals and other movements |
|
(33) |
|
(58) |
|
(13) |
|
(104) |
|
Exchange adjustments |
|
(62) |
|
(15) |
|
(2) |
|
(79) |
|
At 31 December 2022 |
|
1,182 |
|
329 |
|
32 |
|
1,543 |
|
Additions through business combinations (Note 27) |
|
8 |
|
– |
|
– |
|
8 |
|
Additions – separately acquired |
|
220 |
|
219 |
|
5 |
|
444 |
|
Disposals and other movements |
|
(71) |
|
(57) |
|
(2) |
|
(130) |
|
Exchange adjustments |
|
13 |
|
4 |
|
1 |
|
18 |
|
At 31 December 2023 |
|
1,352 |
|
495 |
|
36 |
|
1,883 |
|
Depreciation and impairment |
|
|
|
|
|
|
|
|
|
At 1 January 2021 |
|
247 |
|
117 |
|
13 |
|
377 |
|
Depreciation charge for the year |
|
144 |
|
85 |
|
6 |
|
235 |
|
Disposals and other movements |
|
(54) |
|
(42) |
|
– |
|
(96) |
|
Exchange adjustments |
|
(11) |
|
(6) |
|
– |
|
(17) |
|
At 31 December 2021 |
|
326 |
|
154 |
|
19 |
|
499 |
|
Depreciation charge for the year |
|
160 |
|
80 |
|
6 |
|
246 |
|
Impairment charge |
|
2 |
|
– |
|
– |
|
2 |
|
Disposals and other movements |
|
(54) |
|
(50) |
|
(10) |
|
(114) |
|
Exchange adjustments |
|
(23) |
|
(8) |
|
(1) |
|
(32) |
|
At 31 December 2022 |
|
411 |
|
176 |
|
14 |
|
601 |
|
Depreciation charge for the year |
|
170 |
|
98 |
|
7 |
|
275 |
|
Impairment charge |
|
14 |
|
– |
|
– |
|
14 |
|
Disposals and other movements |
|
(53) |
|
(61) |
|
(2) |
|
(116) |
|
Exchange adjustments |
|
7 |
|
2 |
|
– |
|
9 |
|
At 31 December 2023 |
|
549 |
|
215 |
|
19 |
|
783 |
|
Net book value |
|
|
|
|
|
|
|
|
|
At 31 December 2021 |
|
807 |
|
167 |
|
14 |
|
988 |
|
At 31 December 2022 |
|
771 |
|
153 |
|
18 |
|
942 |
|
At 31 December 2023 |
|
803 |
|
280 |
|
17 |
|
1,100 |
|
Lease liabilities
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
The present value of lease liabilities is as follows: |
|
|
|
|
|
|
|
Within one year |
|
(271) |
|
(228) |
|
(233) |
|
Later than one year and not later than five years |
|
(657) |
|
(549) |
|
(544) |
|
Later than five years |
|
(200) |
|
(176) |
|
(210) |
|
Total lease liabilities |
|
(1,128) |
|
(953) |
|
(987) |
|
The interest expense on lease liabilities included within Finance expense was $33m (2022: $24m; 2021: $22m).
The total cash outflow for leases in 2023 was $301m (2022: $268m; 2021: $262m).
The Group has entered into lease contracts that have not yet commenced. The nominal value of estimated future lease payments under these lease contracts approximates $1,615m as of 31 December 2023. Of this value, $1,348m relates to a property lease in the US which is expected to commence in 2026 with a lease term of 15 years.
In 2022 the Group entered into a sale and leaseback agreement in relation to the Waltham R&D site in MA, US. Prior to the sale, the carrying value of the Property, plant and equipment was $124m. Cash proceeds of $265m were received, recorded within Disposal of property, plant and equipment within the Consolidated Statement of Cash Flows, and a gain on disposal of $125m was recorded within Other operating income and expense within the Consolidated Statement of Comprehensive Income. A lease liability and a corresponding right-of-use asset were recorded of $28m and $13m, respectively.
F-24
9 Goodwill
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Cost |
|
|
|
|
|
|
|
At 1 January |
|
20,131 |
|
20,311 |
|
12,164 |
|
Additions through business combinations (Note 27) |
|
158 |
|
15 |
|
8,287 |
|
Exchange and other adjustments |
|
72 |
|
(195) |
|
(140) |
|
At 31 December |
|
20,361 |
|
20,131 |
|
20,311 |
|
Amortisation and impairment losses |
|
|
|
|
|
|
|
At 1 January |
|
311 |
|
314 |
|
319 |
|
Exchange and other adjustments |
|
2 |
|
(3) |
|
(5) |
|
At 31 December |
|
313 |
|
311 |
|
314 |
|
Net book value |
|
|
|
|
|
|
|
At 31 December |
|
20,048 |
|
19,820 |
|
19,997 |
|
Goodwill is tested for impairment at the operating segment level, this being the level at which goodwill is monitored for internal management purposes. As detailed in Note 6, the Group does not have multiple operating segments and is engaged in a single business activity of pharmaceuticals.
Recoverable amount is determined on a fair value less costs to sell basis using the market value of the Company’s outstanding Ordinary Shares. Our market capitalisation is compared to the book value of the Group’s net assets and this indicates a significant surplus at 31 December 2023 (and 31 December 2022 and 31 December 2021). No goodwill impairment was identified.
10 Intangible assets
|
|
Product, |
|
|
|
Software |
|
|
|
|
|
marketing and |
|
Other |
|
development |
|
|
|
|
|
distribution rights |
|
intangibles |
|
costs |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
Cost |
|
|
|
|
|
|
|
|
|
At 1 January 2021 |
|
42,677 |
|
2,642 |
|
1,288 |
|
46,607 |
|
Additions through business combinations (Note 27) |
|
26,455 |
|
430 |
|
70 |
|
26,955 |
|
Additions – separately acquired |
|
587 |
|
6 |
|
119 |
|
712 |
|
Transferred to Assets held for sale (Note 18) |
|
(1,266) |
|
(47) |
|
– |
|
(1,313) |
|
Disposals |
|
(801) |
|
(402) |
|
(23) |
|
(1,226) |
|
Exchange and other adjustments |
|
(1,062) |
|
(18) |
|
(22) |
|
(1,102) |
|
At 31 December 2021 |
|
66,590 |
|
2,611 |
|
1,432 |
|
70,633 |
|
Additions through business combinations (Note 27) |
|
– |
|
46 |
|
– |
|
46 |
|
Additions – separately acquired |
|
2,051 |
|
12 |
|
105 |
|
2,168 |
|
Disposals |
|
(57) |
|
(105) |
|
(36) |
|
(198) |
|
Exchange and other adjustments |
|
(1,799) |
|
(122) |
|
(106) |
|
(2,027) |
|
At 31 December 2022 |
|
66,785 |
|
2,442 |
|
1,395 |
|
70,622 |
|
Additions through business combinations (Note 27) |
|
65 |
|
35 |
|
– |
|
100 |
|
Additions – separately acquired |
|
2,530 |
|
200 |
|
170 |
|
2,900 |
|
Disposals |
|
(669) |
|
– |
|
(14) |
|
(683) |
|
Exchange and other adjustments |
|
496 |
|
30 |
|
24 |
|
550 |
|
At 31 December 2023 |
|
69,207 |
|
2,707 |
|
1,575 |
|
73,489 |
|
Amortisation and impairment losses |
|
|
|
|
|
|
|
|
|
At 1 January 2021 |
|
22,564 |
|
2,128 |
|
968 |
|
25,660 |
|
Amortisation for year |
|
2,908 |
|
172 |
|
63 |
|
3,143 |
|
Impairment charges |
|
2,067 |
|
– |
|
18 |
|
2,085 |
|
Transferred to Assets held for sale (Note 18) |
|
(931) |
|
(14) |
|
– |
|
(945) |
|
Disposals |
|
(797) |
|
(402) |
|
(21) |
|
(1,220) |
|
Exchange and other adjustments |
|
(535) |
|
(21) |
|
(26) |
|
(582) |
|
At 31 December 2021 |
|
25,276 |
|
1,863 |
|
1,002 |
|
28,141 |
|
Amortisation for year |
|
3,899 |
|
181 |
|
76 |
|
4,156 |
|
Impairment charges |
|
236 |
|
82 |
|
– |
|
318 |
|
Impairment reversals |
|
(77) |
|
– |
|
(17) |
|
(94) |
|
Disposals |
|
(55) |
|
(105) |
|
(20) |
|
(180) |
|
Exchange and other adjustments |
|
(887) |
|
(76) |
|
(63) |
|
(1,026) |
|
At 31 December 2022 |
|
28,392 |
|
1,945 |
|
978 |
|
31,315 |
|
Amortisation for year |
|
3,771 |
|
75 |
|
80 |
|
3,926 |
|
Impairment charges |
|
434 |
|
– |
|
– |
|
434 |
|
Disposals |
|
(667) |
|
– |
|
(12) |
|
(679) |
|
Exchange and other adjustments |
|
336 |
|
41 |
|
27 |
|
404 |
|
At 31 December 2023 |
|
32,266 |
|
2,061 |
|
1,073 |
|
35,400 |
|
Net book value |
|
|
|
|
|
|
|
|
|
At 31 December 2021 |
|
41,314 |
|
748 |
|
430 |
|
42,492 |
|
At 31 December 2022 |
|
38,393 |
|
497 |
|
417 |
|
39,307 |
|
At 31 December 2023 |
|
36,941 |
|
646 |
|
502 |
|
38,089 |
|
F-25
|
|
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
|
|
$m |
|
$m |
|
$m |
|
Net book value |
|
|
|
|
|
|
|
|
|
Current intangible assets |
|
|
|
– |
|
– |
|
105 |
|
Non-current intangible assets |
|
|
|
38,089 |
|
39,307 |
|
42,387 |
|
At 31 December |
|
|
|
38,089 |
|
39,307 |
|
42,492 |
|
Other intangibles consist mainly of research and device technologies and the Alexion brand name. Included within Software development costs are assets currently in development that will commence amortisation when ready for use.
Included within Additions − separately acquired are amounts of $625m (2022: $1,135m; 2021: $124m), relating to deferred payments and other non-cash consideration for the acquisition of Product, marketing and distribution rights, which are not reflected in the current year Consolidated Statement of Cash Flows. Disposals include amounts related to fully depreciated assets that are no longer in use by the Group.
Amortisation charges are recognised in profit as follows:
|
|
Product, |
|
|
|
Software |
|
|
|
|
|
marketing and |
|
Other |
|
development |
|
|
|
|
|
distribution rights |
|
intangibles |
|
costs |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
Year ended 31 December 2021 |
|
|
|
|
|
|
|
|
|
Cost of sales |
|
66 |
|
– |
|
– |
|
66 |
|
Research and development expense |
|
– |
|
33 |
|
– |
|
33 |
|
Selling, general and administrative expense |
|
2,842 |
|
138 |
|
63 |
|
3,043 |
|
Other operating income and expense |
|
– |
|
1 |
|
– |
|
1 |
|
Total |
|
2,908 |
|
172 |
|
63 |
|
3,143 |
|
Year ended 31 December 2022 |
|
|
|
|
|
|
|
|
|
Cost of sales |
|
32 |
|
– |
|
– |
|
32 |
|
Research and development expense |
|
– |
|
30 |
|
– |
|
30 |
|
Selling, general and administrative expense |
|
3,867 |
|
151 |
|
76 |
|
4,094 |
|
Total |
|
3,899 |
|
181 |
|
76 |
|
4,156 |
|
Year ended 31 December 2023 |
|
|
|
|
|
|
|
|
|
Cost of sales |
|
32 |
|
– |
|
– |
|
32 |
|
Research and development expense |
|
– |
|
28 |
|
– |
|
28 |
|
Selling, general and administrative expense |
|
3,739 |
|
47 |
|
80 |
|
3,866 |
|
Total |
|
3,771 |
|
75 |
|
80 |
|
3,926 |
|
Net impairment charges are recognised in profit as follows:
|
|
Product, |
|
|
|
Software |
|
|
|
|
|
marketing and |
|
Other |
|
development |
|
|
|
|
|
distribution rights |
|
intangibles |
|
costs |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
Year ended 31 December 2021 |
|
|
|
|
|
|
|
|
|
Research and development expense |
|
1,464 |
|
– |
|
– |
|
1,464 |
|
Selling, general and administrative expense |
|
603 |
|
– |
|
18 |
|
621 |
|
Total |
|
2,067 |
|
– |
|
18 |
|
2,085 |
|
Year ended 31 December 2022 |
|
|
|
|
|
|
|
|
|
Research and development expense |
|
95 |
|
– |
|
– |
|
95 |
|
Selling, general and administrative expense |
|
64 |
|
82 |
|
(17) |
|
129 |
|
Total |
|
159 |
|
82 |
|
(17) |
|
224 |
|
Year ended 31 December 2023 |
|
|
|
|
|
|
|
|
|
Research and development expense |
|
417 |
|
– |
|
– |
|
417 |
|
Selling, general and administrative expense |
|
17 |
|
– |
|
– |
|
17 |
|
Total |
|
434 |
|
– |
|
– |
|
434 |
|
Impairment charges and reversals
We perform a rigorous impairment trigger assessment for all our intangible assets. Intangible assets under development and not available for use are tested annually for impairment and other intangible assets are tested when there is an indication of impairment loss or reversal. Where testing is required, the recoverable amount of the assets is estimated in order to determine the extent of the impairment loss or reversal. Where it is not possible to estimate the recoverable amount of an individual asset, the Group estimates the recoverable amount of the Cash Generating Unit (CGU) to which it belongs. The Group considers that as the intangible assets are linked to individual products and that product cash flows are considered to be largely independent of other product cash flows, the CGU for intangibles is at the product level. Group-level budgets and forecasts include forecast capital investment and operational impacts related to sustainability projects, as well as inflationary impacts, and form the basis for the value in use models used for impairment testing.
An asset’s recoverable amount is determined as the higher of an asset’s or CGU’s fair value less costs to sell or value in use, in both cases using discounted cash flow calculations where the asset’s expected post-tax cash flows are risk-adjusted over their estimated remaining period of expected economic benefit. Where the value in use approach is used, the post-tax risk-adjusted cash flows are discounted using AstraZeneca’s post-tax weighted average cost of capital (7.5% for 2023, 7% for 2022 and 2021) which is a nominal rate. There is no material difference in the approach taken to using pre-tax cash flows and a pre-tax rate compared to post-tax cash flows and a post-tax rate, as required by IAS 36. Where fair value less costs to sell is used to determine recoverable value, the discount rate is assessed with reference to a market participant; this is not usually materially different to the AstraZeneca post-tax weighted average cost of capital of 7.5%. Intangible assets have been tested for impairment under the value in use basis at risk-adjusted post-tax discount rates ranging between 7.5% to 9.5%.
F-26
Key assumptions and significant estimates used in calculating the recoverable amounts are highly sensitive and specific to the nature of the Group’s activities including:
| > | outcome of R&D activities |
| > | probability of technical and regulatory success |
| > | market volume, share and pricing (to derive peak year sales) |
| > | amount and timing of projected future cash flows |
| > | sales erosion curves following patent expiry. |
Whilst the intangible assets portfolio is generally exposed to significant impairment risk within the next financial year, no sensitivities have been disclosed since no specific asset has been identified as having a significant risk of a material impairment arising from reasonably possible changes in key assumptions.
For assets held at fair value less costs to sell, we make appropriate adjustments to reflect market participant assessments.
In 2023, the Group recorded impairment charges of $17m in respect of launched products. Impairment charges recorded against products in development totalled $417m, including $244m related to ALXN1840 which was fully impaired following the decision to discontinue development.
In 2022, the Group recorded impairment charges of $146m in respect of launched products. Impairment charges recorded against products in development totalled $172m due to decisions made to terminate the related activities.
In 2021, the Group recorded impairment charges of $603m in respect of launched products, including Bydureon ($469m, revised carrying amount of $50m) under value in use model, roxadustat ($121m, revised carrying amount of $215m) under value in use model and other launched products totalling $13m.
Impairment charges recorded against products in development in 2021, based on fair value less costs to sell, totalled $1,464m, principally Ardea ($1,172m) which was fully impaired following the decision to discontinue development of verinurad. The remaining impairments relate to full impairments of various products in development, due to either management’s decision to discontinue development as part of a Group-wide portfolio prioritisation review, or due to the outcome of research activities.
The Group has performed an assessment on assets which have had impairments recorded in previous periods to determine if any reversals of impairments were required. No impairment reversals were recorded in 2023. Impairment reversals of $94m were recorded in 2022, including $77m in respect of products in development. No impairment reversals were recorded in 2021.
When launched products are partially impaired, the carrying values of these assets in future periods are particularly sensitive to changes in forecast assumptions, including those assumptions set out above, as the asset is impaired down to its recoverable amount.
Significant assets
|
|
Carrying value |
|
Remaining amortisation |
|
|
|
$m |
|
period |
|
C5 franchise (Soliris/Ultomiris) intangible assets arising from the acquisition of Alexion |
|
14,356 |
|
4 to 12 years |
|
Intangible assets arising from the acquisition of Acerta Pharma |
|
4,335 |
|
9 years |
|
Strensiq, Kanuma, Andexxa intangible assets arising from the acquisition of Alexion |
|
4,147 |
|
9 to 15 years |
|
Enhertu intangible assets acquired from Daiichi Sankyo |
|
2,831 |
|
10 years |
|
Intangible asset products in development arising from the acquisition of Alexion1 |
|
2,489 |
|
Not amortised |
|
Intangible assets arising from the acquisition of ZS Pharma Inc. |
|
1,838 |
|
8 years |
|
Other intangible assets acquired from Daiichi Sankyo1 |
|
989 |
|
Not amortised |
|
Baxdrostat intangible asset acquired from CinCor Pharma, Inc.1 |
|
780 |
|
Not amortised |
|
Airsupra intangible asset |
|
524 |
|
11 years |
|
Intangible assets arising from the restructuring of a historical joint venture with MSD |
|
472 |
|
3 to 6 years |
|
Farxiga/Forxiga intangible assets acquired from BMS |
|
426 |
|
3 years |
|
Intangible assets arising from the acquisition of Pearl Therapeutics, Inc |
|
412 |
|
5 to 6 years |
|
Monalizumab intangible assets acquired from Innate Pharma1 |
|
370 |
|
Not amortised |
|
RSV franchise assets arising from the acquisition of MedImmune |
|
305 |
|
2 years |
|
Rare disease portfolio assets acquired from Pfizer1 |
|
300 |
|
Not amortised |
|
| 1 | Assets in development are not amortised but are tested annually for impairment. |
The intangible asset baxdrostat recognised on acquisition of CinCor Pharma, Inc. in 2023 was assessed under the optional concentration test in IFRS 3 and was determined to be an asset acquisition, as substantially all of the value of the gross assets acquired was concentrated in this single asset.
The acquisition of Pfizer’s pre-clinical rare disease gene therapy portfolio in 2023 was assessed under IFRS 3 and the transaction was treated as an asset acquisition.
11 Investments in associates and joint ventures
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
At 1 January |
|
76 |
|
69 |
|
39 |
|
Additions |
|
80 |
|
26 |
|
92 |
|
Share of after tax losses |
|
(12) |
|
(5) |
|
(64) |
|
Exchange and other adjustments |
|
3 |
|
(14) |
|
2 |
|
At 31 December |
|
147 |
|
76 |
|
69 |
|
F-27
On 1 November 2023, AstraZeneca entered into an agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet medical need, including oncology, immunology and rare diseases. Under the terms of the agreement, AstraZeneca contributed $80m in funds and holds a 22% interest in the associate entity.
On 29 January 2021, AstraZeneca entered into an agreement with IHP Holdings Limited to create and run an online platform (iHospital) offering consultations with physicians, repeat prescriptions and e-pharmacy in China. The agreement resulted in the formation of a new entity, IHP HK 27 Holdings Limited. AstraZeneca contributed $30m in initial funds and holds a 50% interest in the associate entity.
On 1 December 2020, AstraZeneca and China International Capital Corporation (CICC) entered into an agreement to set up a Global Healthcare Industrial Fund to drive healthcare system innovation by leveraging local capital and accelerating China-related innovation incubation. The agreement resulted in the formation of a new entity, Wuxi AstraZeneca-CICC Venture Capital Partnership (Limited Partnership). AstraZeneca holds a 22% interest in the associate entity and contributed $1m in initial funds in 2020, with contributions of $45m and $21m made in 2021 and 2022 respectively.
On 23 September 2021, AstraZeneca entered into an agreement with VaxEquity Limited to collaborate and develop self-amplifying RNA technology with the aim of generating treatments for target diseases. AstraZeneca contributed $14m in initial funds and holds a 40% interest in the associate entity.
On 23 February 2018, AstraZeneca entered into an agreement with a consortium of investors to form a new, US-domiciled standalone company called Viela Bio. In February 2021, AstraZeneca agreed to divest its 26.7% ownership in Viela Bio, as part of the acquisition of Viela by Horizon Therapeutics plc. AstraZeneca received cash proceeds and profit of $776m upon closing with the profit recorded as Other operating income. In 2021, prior to divestment, the Group provided transitional research and development services to Viela Bio, comprising $1m of passed-through third-party costs incurred by the Group on behalf of Viela Bio.
On 27 November 2017, AstraZeneca entered into a joint venture agreement with Chinese Future Industry Investment Fund (FIIF), to discover, develop and commercialise potential new medicines to help address unmet medical needs globally, and to bring innovative new medicines to patients in China more quickly. The agreement resulted in the formation of a joint venture entity based in China, Dizal (Jiangsu) Pharmaceutical Co., Limited (Dizal). Since its establishment, AstraZeneca has contributed $80m in cash to the joint venture entity and has a 27% interest in the joint venture.
On 1 December 2015, AstraZeneca entered into a joint venture agreement with Fujifilm Kyowa Kirin Biologics Co., Ltd. to develop a biosimilar using the combined capabilities of the two parties. The agreement resulted in the formation of a joint venture entity based in the UK, Centus Biotherapeutics Limited (Centus). Since its establishment, AstraZeneca has contributed $135m in cash to the joint venture entity and has a 50% interest in the joint venture. On 26 April 2023, Centus entered a voluntary liquidation process.
All investments are accounted for using the equity method. At 31 December 2023, unrecognised losses in associates and joint ventures totalled $140m (2022: $92m; 2021: $73m) which have not been recognised due to the investment carrying value reaching $nil value.
Aggregated summarised financial information for the associate and joint venture entities is set out below:
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Non-current assets |
|
424 |
|
290 |
|
215 |
|
Current assets |
|
362 |
|
300 |
|
506 |
|
Total liabilities |
|
(287) |
|
(72) |
|
(99) |
|
Net assets |
|
499 |
|
518 |
|
622 |
|
Amount attributable to AstraZeneca |
|
85 |
|
91 |
|
65 |
|
Goodwill |
|
52 |
|
– |
|
– |
|
Exchange adjustments |
|
10 |
|
(15) |
|
4 |
|
Carrying value of investments in associates and joint ventures |
|
147 |
|
76 |
|
69 |
|
Joint contractual arrangements were entered into between AstraZeneca and Daiichi Sankyo Company Limited (Daiichi Sankyo); in March 2019 for the co-development and co-commercialisation of Enhertu and in July 2020 for the co-development and co-commercialisation of Dato-DXd. Each party shares global pre-tax net income from the collaboration on a 50:50 basis (with the exception of Japan where Daiichi Sankyo maintains exclusive rights and AstraZeneca receives a royalty). The joint operation is not structured through a separate legal entity, and it operates from AstraZeneca and Daiichi Sankyo’s respective principal places of business.
12 Other investments
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Non-current investments |
|
|
|
|
|
|
|
Equity securities at fair value through Other comprehensive income |
|
1,530 |
|
1,056 |
|
1,168 |
|
Fixed income securities at fair value through profit or loss |
|
– |
|
10 |
|
– |
|
Total |
|
1,530 |
|
1,066 |
|
1,168 |
|
Current investments |
|
|
|
|
|
|
|
Fixed income securities at fair value through profit or loss |
|
20 |
|
13 |
|
16 |
|
Cash collateral pledged to counterparties |
|
102 |
|
162 |
|
– |
|
Fixed deposits |
|
– |
|
64 |
|
53 |
|
Total |
|
122 |
|
239 |
|
69 |
|
Other investments held at FVOCI include equity securities which are not held for trading and which the Group has irrevocably elected at initial recognition to recognise in this category. Other investments held at FVPL mainly comprise fixed income securities that the Group holds to sell.
The fair value of listed investments is based on year end quoted market prices. Fixed deposits and Cash collateral pledged to counterparties are held at amortised cost with carrying value being a reasonable approximation of fair value given their short-term nature.
Cash collateral pledged to counterparties relates to collateral pledged on derivatives entered into to hedge the Group's risk exposures. In 2022, following significant foreign currency volatility increasing the collateral requirements, the Group revised its presentation to ‘Other investments’. In 2021 amounts of $47m are presented within Cash and cash equivalents.
F-28
Fair value hierarchy
The table below analyses equity securities and bonds, contained within Other investments and carried at fair value, by valuation method. The different levels have been defined as follows:
| > | Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities |
| > | Level 2: inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (i.e. as prices) or indirectly (i.e. derived from prices) |
| > | Level 3: inputs for the asset or liability that are not based on observable market data (unobservable inputs). |
|
|
2023 |
|
2023 |
|
2022 |
|
2022 |
|
2021 |
|
2021 |
|
|
|
FVPL |
|
FVOCI |
|
FVPL |
|
FVOCI |
|
FVPL |
|
FVOCI |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Level 1 |
|
20 |
|
1,217 |
|
13 |
|
880 |
|
16 |
|
1,064 |
|
Level 2 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
Level 3 |
|
– |
|
313 |
|
10 |
|
176 |
|
– |
|
104 |
|
Total |
|
20 |
|
1,530 |
|
23 |
|
1,056 |
|
16 |
|
1,168 |
|
Assets are transferred in or out of each Level on the date of the event or change in circumstances that caused the transfer.
Equity securities that are analysed at Level 3 include investments in private biotech companies. In the absence of specific market data, these unlisted investments are held at fair value based on the cost of investment and adjusting as necessary for impairments and revaluations on new funding rounds, which approximates to fair value. Movements in Level 3 investments are detailed below:
|
|
2023 |
|
2023 |
|
2022 |
|
2022 |
|
2021 |
|
|
|
FVPL |
|
FVOCI |
|
FVPL |
|
FVOCI |
|
FVOCI |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
At 1 January |
|
10 |
|
176 |
|
– |
|
104 |
|
217 |
|
Additions |
|
– |
|
127 |
|
10 |
|
32 |
|
1 |
|
Revaluations |
|
3 |
|
14 |
|
– |
|
50 |
|
– |
|
Net transfers out from Level 3 to Level 1 |
|
– |
|
– |
|
– |
|
(4) |
|
(113) |
|
Disposals |
|
(13) |
|
(8) |
|
– |
|
(5) |
|
– |
|
Impairments and exchange adjustments |
|
– |
|
4 |
|
– |
|
(1) |
|
(1) |
|
At 31 December |
|
– |
|
313 |
|
10 |
|
176 |
|
104 |
|
13 Derivative financial instruments
|
|
Non-current |
|
Current |
|
Current |
|
Non-current |
|
|
|
|
|
assets |
|
assets |
|
liabilities |
|
liabilities |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Interest rate swaps related to instruments designated at fair value through profit or loss1 |
|
25 |
|
– |
|
– |
|
– |
|
25 |
|
Cross currency swaps designated in a net investment hedge |
|
62 |
|
– |
|
– |
|
(2) |
|
60 |
|
Cross currency swaps designated in a cash flow hedge |
|
– |
|
– |
|
– |
|
(43) |
|
(43) |
|
Forward FX designated in a cash flow hedge2 |
|
– |
|
13 |
|
– |
|
– |
|
13 |
|
Other derivatives |
|
15 |
|
70 |
|
(79) |
|
– |
|
6 |
|
31 December 2021 |
|
102 |
|
83 |
|
(79) |
|
(45) |
|
61 |
|
|
|
Non-current |
|
Current |
|
Current |
|
Non-current |
|
|
|
|
|
assets |
|
assets |
|
liabilities |
|
liabilities |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Interest rate swaps related to instruments designated at fair value through profit or loss1 |
|
– |
|
1 |
|
– |
|
– |
|
1 |
|
Cross currency swaps designated in a net investment hedge |
|
55 |
|
– |
|
– |
|
(4) |
|
51 |
|
Cross currency swaps designated in a cash flow hedge |
|
– |
|
– |
|
– |
|
(160) |
|
(160) |
|
Forward FX designated in a cash flow hedge2 |
|
– |
|
1 |
|
(13) |
|
– |
|
(12) |
|
Other derivatives |
|
19 |
|
85 |
|
(80) |
|
– |
|
24 |
|
31 December 2022 |
|
74 |
|
87 |
|
(93) |
|
(164) |
|
(96) |
|
|
|
Non-current |
|
Current |
|
Current |
|
Non-current |
|
|
|
|
|
assets |
|
assets |
|
liabilities |
|
liabilities |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Cross currency swaps designated in a net investment hedge |
|
100 |
|
– |
|
– |
|
(1) |
|
99 |
|
Cross currency swaps designated in a cash flow hedge |
|
116 |
|
– |
|
(30) |
|
(37) |
|
49 |
|
Forward FX designated in a cash flow hedge2 |
|
– |
|
19 |
|
(4) |
|
– |
|
15 |
|
Other derivatives |
|
12 |
|
97 |
|
(122) |
|
– |
|
(13) |
|
31 December 2023 |
|
228 |
|
116 |
|
(156) |
|
(38) |
|
150 |
|
| 1 | Interest rate swaps related to instruments designated at fair value through profit or loss matured in 2023. |
| 2 | Forward FX designated in a cash flow hedge relates to contracts hedging anticipated CNY, EUR, GBP, JPY and SEK transactions occurring in the quarter immediately after the balance sheet date. |
All derivatives are held at fair value and fall within Level 2 of the fair value hierarchy as defined in Note 12, except for an equity warrant which falls within Level 3 (valued at $12m (2022: $19m; 2021: $15m), held within Non-current assets). None of the derivatives have been reclassified in the year.
The fair value of interest rate swaps and cross currency swaps is estimated using appropriate zero coupon curve valuation techniques to discount future contractual cash flows based on rates at the current year end.
The fair value of forward foreign exchange contracts and currency options are estimated by cash flow accounting models using appropriate yield curves based on market forward foreign exchange rates at the year end. The majority of forward foreign exchange contracts for existing transactions had maturities of less than one month from year end.
F-29
The interest rates used to discount future cash flows for fair value adjustments, where applicable, are based on market swap curves at the reporting date, and were as follows:
|
|
|
|
|
2023 |
|
|
|
|
2022 |
|
|
|
|
2021 |
|
Derivatives |
|
0.1 |
% |
to |
5.3 |
% |
0.1 |
% |
to |
4.7 |
% |
(0.5) |
% |
to |
3.6 |
% |
14 Non-current other receivables
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Prepayments |
|
274 |
|
243 |
|
391 |
|
Accrued income |
|
52 |
|
44 |
|
61 |
|
Retirement benefit scheme surpluses (Note 22) |
|
92 |
|
90 |
|
– |
|
Other receivables |
|
385 |
|
458 |
|
443 |
|
Non-current other receivables |
|
803 |
|
835 |
|
895 |
|
Prepayments include $nil (2022: $nil; 2021: $92m) in relation to our research collaboration with Moderna. Other receivables include $51m (2022: $71m; 2021: $44m) owed by FibroGen, Inc. for promotional activity in China pursuant to the roxadustat collaboration.
15 Inventories
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Raw materials and consumables |
|
1,531 |
|
1,422 |
|
1,755 |
|
Inventories in process |
|
2,325 |
|
1,864 |
|
5,216 |
|
Finished goods and goods for resale |
|
1,568 |
|
1,413 |
|
2,012 |
|
Inventories |
|
5,424 |
|
4,699 |
|
8,983 |
|
The Group recognised $6,038m (2022: $9,618m; 2021: $9,640m) of inventories as an expense within Cost of sales during the year.
Inventory write-downs in the year amounted to $574m (2022: $479m; 2021: $552m), principally arising from the reassessment of usage or demand expectations prior to inventory expiration.
16 Current trade and other receivables
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Trade receivables |
|
8,452 |
|
7,271 |
|
6,054 |
|
Less: Expected credit loss provision (Note 28) |
|
(45) |
|
(59) |
|
(23) |
|
|
|
8,407 |
|
7,212 |
|
6,031 |
|
Other receivables |
|
1,639 |
|
1,659 |
|
1,808 |
|
Prepayments |
|
1,617 |
|
1,329 |
|
1,512 |
|
Government grants receivable |
|
11 |
|
25 |
|
– |
|
Accrued income |
|
452 |
|
296 |
|
293 |
|
Trade and other receivables |
|
12,126 |
|
10,521 |
|
9,644 |
|
Trade receivables include $1,977m (2022: $2,470m; 2021: $1,865m) measured at FVOCI classified ‘hold to collect and sell’ as they are due from customers that the Group has the option to factor, or relate to bank acceptance drafts received in settlement of trade receivables per common practice in China.
All other financial assets included within Current trade and other receivables are held at amortised cost with carrying value being a reasonable approximation of fair value.
17 Cash and cash equivalents
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Cash at bank and in hand |
|
1,325 |
|
1,411 |
|
1,461 |
|
Short-term deposits |
|
4,515 |
|
4,755 |
|
4,868 |
|
Cash and cash equivalents |
|
5,840 |
|
6,166 |
|
6,329 |
|
Unsecured bank overdrafts |
|
(203) |
|
(183) |
|
(291) |
|
Cash and cash equivalents in the cash flow statement |
|
5,637 |
|
5,983 |
|
6,038 |
|
AstraZeneca invests in constant net asset value funds, low-volatility net asset value funds and short-term variable net asset value funds with same day access for subscription and redemption. These investments fail the ‘solely payments of principal and interest’ test criteria under IFRS 9. They are therefore measured at FVPL, although the fair value is materially the same as amortised cost.
F-30
Non-cash and other movements, within operating activities in the Consolidated Statement of Cash Flows, includes:
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Share-based payments charge for the period |
|
579 |
|
619 |
|
615 |
|
Settlement of share plan awards |
|
(650) |
|
(592) |
|
(570) |
|
Pension contributions |
|
(188) |
|
(205) |
|
(174) |
|
Pension charges recorded in operating profit |
|
55 |
|
101 |
|
136 |
|
Long-term provision charges recorded in operating profit |
|
460 |
|
87 |
|
270 |
|
(Gain)/loss on disposal of tangible assets |
|
(41) |
|
(112) |
|
4 |
|
Update to the contractual relationships for Beyfortus (nirsevimab) |
|
(729) |
|
– |
|
– |
|
Foreign exchange and other1 |
|
128 |
|
(590) |
|
(186) |
|
Total operating activities non-cash and other movements |
|
(386) |
|
(692) |
|
95 |
|
| 1 | Foreign exchange and other includes, among other items, the foreign exchange of inter-company transactions, including dividends, across Group entities and the related impact from hedging those transactions. |
18 Assets held for sale
Assets held for sale amount to $nil (2022: $150m; 2021: $368m).
In 2022, Assets held for sale comprised Property, plant and equipment assets relating to the West Chester site in Ohio, US. The transaction closed on 30 January 2023.
In 2021, Assets held for sale comprised Intangible assets relating to the rights to certain respiratory assets acquired from Almirall and Actavis plc. (including Tudorza and Duaklir). The transaction closed on 4 January 2022.
F-31
19 Interest-bearing loans and borrowings
|
|
|
|
Repayment |
|
2023 |
|
2022 |
|
2021 |
|
|
|
|
|
dates |
|
$m |
|
$m |
|
$m |
|
Current liabilities |
|
|
|
|
|
|
|
|
|
|
|
Bank overdrafts |
|
|
|
On demand |
|
203 |
|
183 |
|
291 |
|
Other short-term borrowings excluding overdrafts |
|
|
|
|
|
97 |
|
78 |
|
3 |
|
Collateral received from derivative counterparties |
|
|
|
|
|
215 |
|
89 |
|
93 |
|
Lease liabilities |
|
|
|
|
|
271 |
|
228 |
|
233 |
|
Floating rate notes |
|
US dollars |
|
2022 |
|
– |
|
– |
|
250 |
|
2.375% Callable bond |
|
US dollars |
|
2022 |
|
– |
|
– |
|
999 |
|
0.3% Callable bond |
|
US dollars |
|
2023 |
|
– |
|
1,399 |
|
– |
|
2023 Floating bank loan |
|
US dollars |
|
2023 |
|
– |
|
2,000 |
|
– |
|
Floating rate notes |
|
US dollars |
|
2023 |
|
– |
|
400 |
|
– |
|
3.5% Callable bond |
|
US dollars |
|
2023 |
|
– |
|
849 |
|
– |
|
7% Guaranteed debentures |
|
US dollars |
|
2023 |
|
– |
|
294 |
|
– |
|
0.75% Callable bond |
|
euros |
|
2024 |
|
995 |
|
– |
|
– |
|
0.7% Callable bond |
|
US dollars |
|
2024 |
|
1,600 |
|
– |
|
– |
|
2024 Floating rate bank loans |
|
US dollars |
|
2024 |
|
2,000 |
|
– |
|
– |
|
Other loans (including commercial paper) |
|
|
|
Within one year |
|
19 |
|
22 |
|
24 |
|
Total |
|
|
|
|
|
5,400 |
|
5,542 |
|
1,893 |
|
Non-current liabilities |
|
|
|
|
|
|
|
|
|
|
|
Lease liabilities |
|
|
|
|
|
857 |
|
725 |
|
754 |
|
0.3% Callable bond |
|
US dollars |
|
2023 |
|
– |
|
– |
|
1,397 |
|
2023 Floating bank loan |
|
US dollars |
|
2023 |
|
– |
|
– |
|
1,998 |
|
Floating rate notes |
|
US dollars |
|
2023 |
|
– |
|
– |
|
400 |
|
3.5% Callable bond |
|
US dollars |
|
2023 |
|
– |
|
– |
|
848 |
|
7% Guaranteed debentures |
|
US dollars |
|
2023 |
|
– |
|
– |
|
320 |
|
0.75% Callable bond |
|
euros |
|
2024 |
|
– |
|
957 |
|
1,014 |
|
0.7% Callable bond |
|
US dollars |
|
2024 |
|
– |
|
1,598 |
|
1,598 |
|
2024 Floating bank loans |
|
US dollars |
|
2024 |
|
– |
|
1,998 |
|
1,997 |
|
3.375% Callable bond |
|
US dollars |
|
2025 |
|
1,994 |
|
1,992 |
|
1,988 |
|
0.7% Callable bond |
|
US dollars |
|
2026 |
|
1,196 |
|
1,195 |
|
1,193 |
|
1.2% Callable bond |
|
US dollars |
|
2026 |
|
1,248 |
|
1,246 |
|
1,245 |
|
3.625% Callable bond |
|
euros |
|
2027 |
|
829 |
|
– |
|
– |
|
3.125% Callable bond |
|
US dollars |
|
2027 |
|
747 |
|
746 |
|
745 |
|
4.875% Callable bond |
|
US dollars |
|
2028 |
|
1,095 |
|
– |
|
– |
|
1.25% Callable bond |
|
euros |
|
2028 |
|
879 |
|
845 |
|
896 |
|
1.75% Callable bond |
|
US dollars |
|
2028 |
|
1,246 |
|
1,245 |
|
1,244 |
|
4% Callable bond |
|
US dollars |
|
2029 |
|
995 |
|
995 |
|
994 |
|
0.375% Callable bond |
|
euros |
|
2029 |
|
881 |
|
846 |
|
898 |
|
4.9% Callable bond |
|
US dollars |
|
2030 |
|
645 |
|
– |
|
– |
|
1.375% Callable bond |
|
US dollars |
|
2030 |
|
1,294 |
|
1,293 |
|
1,292 |
|
2.25% Callable bond |
|
US dollars |
|
2031 |
|
747 |
|
747 |
|
746 |
|
5.75% Non-callable bond |
|
pound sterling |
|
2031 |
|
444 |
|
420 |
|
470 |
|
3.75% Callable bond |
|
euros |
|
2032 |
|
827 |
|
– |
|
– |
|
4.875% Callable bond |
|
US dollars |
|
2033 |
|
497 |
|
– |
|
– |
|
6.45% Callable bond |
|
US dollars |
|
2037 |
|
2,725 |
|
2,724 |
|
2,724 |
|
4% Callable bond |
|
US dollars |
|
2042 |
|
989 |
|
988 |
|
988 |
|
4.375% Callable bond |
|
US dollars |
|
2045 |
|
981 |
|
981 |
|
980 |
|
4.375% Callable bond |
|
US dollars |
|
2048 |
|
738 |
|
737 |
|
737 |
|
2.125% Callable bond |
|
US dollars |
|
2050 |
|
487 |
|
487 |
|
486 |
|
3% Callable bond |
|
US dollars |
|
2051 |
|
735 |
|
735 |
|
734 |
|
Other loans |
|
US dollars |
|
|
|
146 |
|
190 |
|
202 |
|
Total |
|
|
|
|
|
23,222 |
|
23,690 |
|
28,888 |
|
Total interest-bearing loans and borrowings1, 2 |
|
|
|
|
|
28,622 |
|
29,232 |
|
30,781 |
|
| 1 | All loans and borrowings above are unsecured. In previous years, there were current (2022: $22m; 2021: $24m) and non-current (2022: $181m; 2021: $188m) secured loans, both included within Other loans. |
| 2 | The $2bn USD 2024 floating rate bank loans pay interest rate based on compounded daily USD Secured Overnight Funding Rate (SOFR). |
F-32
|
|
|
|
|
|
|
|
Total |
|
Total |
|
Total |
|
|
|
|
|
|
|
|
|
loans and |
|
loans and |
|
loans and |
|
|
|
|
|
|
|
|
|
borrowings |
|
borrowings |
|
borrowings |
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
$m |
|
$m |
|
$m |
|
At 1 January |
|
|
|
|
|
|
|
29,232 |
|
30,781 |
|
20,380 |
|
Changes from financing cash flows |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of loans and borrowings |
|
|
|
|
|
|
|
3,816 |
|
– |
|
12,929 |
|
Repayment of loans and borrowings |
|
|
|
|
|
|
|
(4,942) |
|
(1,271) |
|
(4,759) |
|
Movement in short-term borrowings |
|
|
|
|
|
|
|
161 |
|
74 |
|
(276) |
|
Repayment of obligations under leases |
|
|
|
|
|
|
|
(268) |
|
(244) |
|
(240) |
|
Total changes in cash flows arising on financing activities from borrowings |
|
|
|
|
|
|
|
(1,233) |
|
(1,441) |
|
7,654 |
|
Movement in overdrafts |
|
|
|
|
|
|
|
20 |
|
(85) |
|
31 |
|
New lease liabilities |
|
|
|
|
|
|
|
444 |
|
253 |
|
503 |
|
Additions through business combinations |
|
|
|
|
|
|
|
– |
|
5 |
|
2,523 |
|
Exchange |
|
|
|
|
|
|
|
187 |
|
(287) |
|
(378) |
|
Other movements |
|
|
|
|
|
|
|
(28) |
|
6 |
|
68 |
|
At 31 December |
|
|
|
|
|
|
|
28,622 |
|
29,232 |
|
30,781 |
|
Also included within cash flows arising from financing activities within the Consolidated Statement of Cash Flows is a $867m cash outflow (2022: outflow of $920m; 2021: $nil) related to the Acerta Pharma share purchase liability which has a closing liability at 31 December 2023 of $833m (2022: $1,646m; 2021: $2,458m) within Trade and other payables (see Note 20).
Set out below is a comparison by category of carrying values and fair values of all the Group’s interest-bearing loans and borrowings:
|
|
|
|
Instruments |
|
Instruments |
|
|
|
Total |
|
|
|
|
|
|
|
designated |
|
designated in |
|
Amortised |
|
carrying |
|
Fair |
|
|
|
|
|
at fair value |
1 |
cash flow hedge |
2 |
cost |
|
value |
|
value |
|
|
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Overdrafts |
|
|
|
– |
|
– |
|
291 |
|
291 |
|
291 |
|
Lease liabilities due within one year |
|
|
|
– |
|
– |
|
233 |
|
233 |
|
233 |
|
Lease liabilities due after more than one year |
|
|
|
– |
|
– |
|
754 |
|
754 |
|
754 |
|
Loans and borrowings due within one year |
|
|
|
– |
|
– |
|
1,369 |
|
1,369 |
|
1,378 |
|
Loans and borrowings due after more than one year |
|
|
|
320 |
|
1,910 |
|
25,904 |
|
28,134 |
|
30,596 |
|
Total at 31 December 2021 |
|
|
|
320 |
|
1,910 |
|
28,551 |
|
30,781 |
|
33,252 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Overdrafts |
|
|
|
– |
|
– |
|
183 |
|
183 |
|
183 |
|
Lease liabilities due within one year |
|
|
|
– |
|
– |
|
228 |
|
228 |
|
228 |
|
Lease liabilities due after more than one year |
|
|
|
– |
|
– |
|
725 |
|
725 |
|
725 |
|
Loans and borrowings due within one year |
|
|
|
294 |
|
– |
|
4,837 |
|
5,131 |
|
5,105 |
|
Loans and borrowings due after more than one year |
|
|
|
– |
|
1,802 |
|
21,163 |
|
22,965 |
|
21,657 |
|
Total at 31 December 2022 |
|
|
|
294 |
|
1,802 |
|
27,136 |
|
29,232 |
|
27,898 |
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Overdrafts |
|
|
|
– |
|
– |
|
203 |
|
203 |
|
203 |
|
Lease liabilities due within one year |
|
|
|
– |
|
– |
|
271 |
|
271 |
|
271 |
|
Lease liabilities due after more than one year |
|
|
|
– |
|
– |
|
857 |
|
857 |
|
857 |
|
Loans and borrowings due within one year |
|
|
|
– |
|
995 |
|
3,931 |
|
4,926 |
|
4,887 |
|
Loans and borrowings due after more than one year |
|
|
|
– |
|
2,535 |
|
19,830 |
|
22,365 |
|
21,769 |
|
Total at 31 December 2023 |
|
|
|
– |
|
3,530 |
|
25,092 |
|
28,622 |
|
27,987 |
|
| 1 | Instruments designated at FVPL include the US dollar 7% guaranteed debentures which matured on 15 November 2023. |
The fair value of fixed-rate publicly traded debt is based on year end quoted market prices; the fair value of floating rate debt is nominal value, as mark-to-market differences would be minimal given the frequency of resets. The carrying value of loans designated at FVPL is the fair value; this falls within the Level 1 valuation method as defined in Note 12. For loans designated in a fair value hedge relationship, carrying value is initially measured at fair value and remeasured for fair value changes in respect of the hedged risk at each reporting date. All other loans are held at amortised cost. Fair values, as disclosed in the table above, are all determined using the Level 1 valuation method as defined in Note 12, with the exception of overdrafts and lease liabilities, where fair value approximates to carrying values.
A loss of $6m was made during the year on the fair value of bonds designated as FVPL. A gain of $25m has been made on these bonds since designation. Under IFRS 9, the Group records the component of fair value changes relating to the component of own credit risk through Other comprehensive income. Changes in credit risk had no material effect on any other financial assets and liabilities recognised at fair value in the Group Financial Statements. The change in fair value attributable to changes in credit risk is calculated as the change in fair value not attributable to market risk.
The interest rates used to discount future cash flows for fair value adjustments, where applicable, are based on market swap curves at the reporting date, and were as follows:
|
|
|
|
|
2023 |
|
|
|
|
2022 |
|
|
|
|
2021 |
|
Loans and borrowings |
|
n/a |
|
to |
n/a |
1 |
4.3 |
% |
to |
4.9 |
% |
0.1 |
% |
to |
0.6 |
% |
| 1 | All bonds designated as FVPL have matured prior to the reporting date. |
F-33
20 Trade and other payables
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Current liabilities |
|
|
|
|
|
|
|
Trade payables |
|
3,267 |
|
2,550 |
|
2,824 |
|
Value-added and payroll taxes and social security |
|
492 |
|
468 |
|
463 |
|
Rebates, chargebacks, returns and other revenue accruals |
|
7,817 |
|
6,078 |
|
5,298 |
|
Clinical trial accruals |
|
1,424 |
|
1,417 |
|
1,047 |
|
Other accruals |
|
6,112 |
|
5,551 |
|
5,649 |
|
Collaboration Revenue contract liabilities |
|
7 |
|
12 |
|
12 |
|
Vaccine contract liabilities |
|
142 |
|
169 |
|
1,003 |
|
Deferred government grant income |
|
– |
|
1 |
|
67 |
|
Contingent consideration |
|
966 |
|
757 |
|
849 |
|
Acerta Pharma share purchase liability (Note 26) |
|
833 |
|
867 |
|
920 |
|
Other payables |
|
1,314 |
|
1,170 |
|
806 |
|
Total |
|
22,374 |
|
19,040 |
|
18,938 |
|
Non-current liabilities |
|
|
|
|
|
|
|
Accruals |
|
36 |
|
37 |
|
25 |
|
Collaboration Revenue contract liabilities |
|
7 |
|
14 |
|
26 |
|
Contingent consideration |
|
1,171 |
|
1,465 |
|
2,016 |
|
Acerta Pharma share purchase liability (Note 26) |
|
– |
|
779 |
|
1,538 |
|
Other payables |
|
1,446 |
|
1,975 |
|
1,328 |
|
Total |
|
2,660 |
|
4,270 |
|
4,933 |
|
Included within Rebates, chargebacks, returns and other revenue accruals are contract liabilities of $102m (2022: $87m; 2021: $99m). The revenue recognised in the year from opening contract liabilities is $88m, comprising $76m relating to other revenue accruals and $12m Collaboration Revenue contract liabilities. The major markets with Rebates, chargebacks, returns and other revenue accruals are the US where the liability at 31 December 2023 amounted to $5,116m (2022: $3,961m; 2021: $3,172m), of which Rare Disease comprises $190m (2022: $139m; 2021: $127m), and China where the liability at 31 December 2023 amounted to $567m (2022: $579m; 2021: $814m).
Trade payables includes $123m (2022: $67m; 2021: $44m) due to suppliers that have signed up to a supply chain financing programme, under which the suppliers can elect on an invoice-by-invoice basis to receive a discounted early payment from the relationship bank rather than being paid in line with the agreed payment terms. If the option is taken, the Group’s liability is assigned by the supplier to be due to the relationship bank rather than the supplier. The value of the liability payable by the Group remains unchanged. The Group assesses the arrangement against indicators to assess if debts which vendors have sold to the funder under the supplier financing scheme continue to meet the definition of trade payables or should be classified as borrowings. At 31 December 2023, the payables met the criteria of Trade payables. The supply chain financing programme operates in the US, UK, Sweden, China and Germany, and as at 31 December 2023, the programme had 461 suppliers enrolled across these countries.
Vaccine contract liabilities relate to amounts received from customers, primarily government bodies, in advance of supply of product.
Deferred government grant income relates to government grants received or receivable but for which the related expenses have not been incurred.
Included within current Other payables are liabilities to Daiichi Sankyo totalling $199m (2022: $100m; 2021: $nil) resulting from the collaboration agreement in relation to Enhertu entered into in March 2019 and $nil (2022: $nil; 2021: $324m) in relation to Dato-DXd entered into in July 2020. Additionally, included within non-current Other payables are liabilities totalling $774m (2022: $1,125m; 2021: $100m) as a result of the Enhertu collaboration agreement and $464m (2022: $nil; 2021: $nil) as a result of the Airsupra collaboration agreement.
In November 2020, Calquence received marketing approval in the EU, which removed all remaining conditionality in respect of the Acerta Pharma put and call options regarding the non-controlling interest; the option was exercised in April 2021 (see Note 26). The payments will be made in similar annual instalments in 2022 through to 2024, with the first payment of $920m made in 2022 and the second payment of $867m made in 2023, with a closing liability as at 31 December 2023 of $833m (2022: $1,646m; 2021: $2,458m). Interest arising from amortising the liability is included within Finance expense (see Note 3). The associated cash flows are disclosed as financing activities within the Consolidated Statement of Cash Flows.
With the exception of Contingent consideration payables of $2,137m (2022: $2,222m; 2021: $2,865m) which are held at fair value within Level 3 of the fair value hierarchy as defined in Note 12, all other financial liabilities are held at amortised cost with carrying value being a reasonable approximation of fair value.
Contingent consideration
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
At 1 January |
|
2,222 |
|
2,865 |
|
3,323 |
|
Additions through business combinations |
|
60 |
|
– |
|
– |
|
Settlements |
|
(826) |
|
(772) |
|
(643) |
|
Disposals |
|
– |
|
(121) |
|
– |
|
Revaluations |
|
549 |
|
82 |
|
14 |
|
Reclassification to Other payables |
|
– |
|
– |
|
(55) |
|
Discount unwind (Note 3) |
|
132 |
|
168 |
|
226 |
|
At 31 December |
|
2,137 |
|
2,222 |
|
2,865 |
|
Contingent consideration arising from business combinations is fair valued using decision-tree analysis, with key inputs including the probability of success, consideration of potential delays and the expected levels of future revenues.
Revaluations of Contingent consideration are recognised in Selling, general and administrative expense and include an increase of $520m in 2023 (2022: an increase of $182m; 2021: an increase of $42m) based on revised milestone probabilities, and revenue and royalty forecasts, relating to the acquisition of BMS’s share of the Global Diabetes Alliance. Discount unwind on the liability is included within Finance expense (see Note 3).
F-34
The discount rate used for the Contingent consideration balances range from 5% to 8%. The most significant Contingent consideration balance is the Global Diabetes Alliance which is discounted at 8% and is reviewed against comparable benchmarks on a regular basis.
Management has identified that reasonably possible changes in certain key assumptions, including the likelihood of achieving successful trial results, obtaining regulatory approval, the projected market share of the therapy area and expected pricing for launched products, may cause the calculated fair value of the above contingent consideration to vary materially in future years.
The contingent consideration balance relating to BMS’s share of Global Diabetes Alliance of $1,945m (2022: $2,124m; 2021: $2,544m) would increase/decrease by $195m with an increase/decrease in sales of 10% as compared with the current estimates.
The maximum development and sales milestones payable under outstanding Contingent consideration arrangements arising on business combinations are as follows:
|
|
|
|
Nature of |
|
Maximum future milestones |
|
Acquisitions |
|
Year |
|
contingent consideration |
|
$m |
|
Spirogen |
|
2013 |
|
Milestones |
|
180 |
|
Amplimmune, Inc. |
|
2013 |
|
Milestones |
|
150 |
|
Almirall1 |
|
2014 |
|
Milestones and royalties |
|
345 |
|
Neogene |
|
2023 |
|
Milestones |
|
110 |
|
| 1 | These contingent consideration liabilities have been designated as the hedge instrument in a net investment hedge of foreign currency risk arising on the Group’s underlying US dollar net investments held in non-US dollar denominated subsidiaries. Exchange differences on the retranslation of the contingent consideration liability are recognised in Other comprehensive income to the extent that the hedge is effective. Any ineffectiveness is taken to profit. |
The amount of royalties payable under the arrangements is inherently uncertain and difficult to predict, given the direct link to future sales and the range of outcomes. The maximum amount of royalties payable in each year is with reference to net sales.
F-35
21 Provisions
|
|
|
|
|
|
Employee |
|
|
|
Other |
|
|
|
|
|
Severance |
|
Environmental |
|
benefits |
|
Legal |
|
provisions |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
At 1 January 2021 |
|
214 |
|
100 |
|
128 |
|
348 |
|
770 |
|
1,560 |
|
Additions through business combinations (Note 27) |
|
– |
|
– |
|
41 |
|
73 |
|
27 |
|
141 |
|
Charge for year |
|
238 |
|
23 |
|
46 |
|
109 |
|
456 |
|
872 |
|
Cash paid |
|
(172) |
|
(32) |
|
(49) |
|
(285) |
|
(84) |
|
(622) |
|
Reversals |
|
(62) |
|
– |
|
– |
|
(5) |
|
(175) |
|
(242) |
|
Exchange and other movements |
|
(6) |
|
(1) |
|
29 |
|
(1) |
|
(6) |
|
15 |
|
At 31 December 2021 |
|
212 |
|
90 |
|
195 |
|
239 |
|
988 |
|
1,724 |
|
Charge for year |
|
227 |
|
61 |
|
1 |
|
830 |
|
365 |
|
1,484 |
|
Cash paid |
|
(223) |
|
(19) |
|
(41) |
|
(814) |
|
(185) |
|
(1,282) |
|
Reversals |
|
(43) |
|
– |
|
(27) |
|
(94) |
|
(98) |
|
(262) |
|
Exchange and other movements |
|
(8) |
|
(1) |
|
15 |
|
– |
|
(52) |
|
(46) |
|
At 31 December 2022 |
|
165 |
|
131 |
|
143 |
|
161 |
|
1,018 |
|
1,618 |
|
Charge for year |
|
123 |
|
21 |
|
22 |
|
1,102 |
|
245 |
|
1,513 |
|
Cash paid |
|
(87) |
|
(41) |
|
(14) |
|
(219) |
|
(404) |
|
(765) |
|
Reversals |
|
(28) |
|
(3) |
|
(3) |
|
(23) |
|
(143) |
|
(200) |
|
Exchange and other movements |
|
3 |
|
4 |
|
20 |
|
(5) |
|
(33) |
|
(11) |
|
At 31 December 2023 |
|
176 |
|
112 |
|
168 |
|
1,016 |
|
683 |
|
2,155 |
|
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Due within one year |
|
1,028 |
|
722 |
|
768 |
|
Due after more than one year |
|
1,127 |
|
896 |
|
956 |
|
Total |
|
2,155 |
|
1,618 |
|
1,724 |
|
Provisions are often subject to substantial uncertainties with regard to the timing and final amounts of any payments. Once established, these amounts remain in Provisions even after settlement is reached and uncertainty resolved, with no transfer to Trade and other payables prior to payment. This is to provide more transparent disclosure of subsequent movements in brought forward and carried forward balances. Settled legal claims included within provisions are held at amortised cost with carrying value being a reasonable approximation of fair value.
Severance provisions arise predominantly in connection with global restructuring initiatives, including the PAAGR, which involve rationalisation of the global supply chain, the sales and marketing organisation, IT and business support infrastructure, and R&D.
In conjunction with the acquisition of Alexion in 2021, the enlarged Group initiated the PAAGR; a global restructuring programme, aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments. This includes the commencement of work on the planned upgrade of the Group's Enterprise Resource Planning IT systems (Axial Project). The Group has also continued to progress other legacy restructuring programmes.
Employee costs in connection with the initiatives are recognised in severance provisions when a detailed formal plan has been communicated to those employees affected. Final severance costs are often subject to the completion of the requisite consultations on the areas impacted, with the majority of the cost expected to be paid within one year. AstraZeneca endeavours to support employees affected by restructuring initiatives to seek alternative roles within the organisation. Where the employee is successful, any severance provisions will be released.
Details of the Environmental provisions totalling $112m (2022: $131m; 2021: $90m) and ongoing matters are provided in Note 30. These uncertainties can also cause reversal in previously established provisions once final settlement is reached.
Legal issues are often subject to substantial uncertainties with regard to the timing and final amounts of any payments. A significant proportion of the total legal provision, $616m (2022: $30m; 2021: $15m) due within one year and $372m (2022: $92m; 2021: $105m) due after more than one year1, relates to matters settled, but not paid, in previous periods, further details are provided in Note 30.
The majority of Employee benefit provisions relate to Executive Deferred Compensation Plans, which include uncertainty over the ultimate timing and amount of payment to be made to the executives.
Other provisions comprise amounts relating to specific contractual or constructive obligations and disputes. Included within Other provisions are amounts associated with long-standing product liability settlements that arose prior to the merger of Astra and Zeneca, which given the nature of the provision, the amounts are expected to be settled over many years; the final settlement values and timings are uncertain. Also included in Other provisions is an amount of $163m (2022: $165m; 2021: $185m), in relation to third-party liability and other risks (including incurred but not yet reported claims); the claims are considered to be uncertain as to timing and amount. Charges to Other provisions in 2023 included $87m (2022: $12m; 2021: $243m) in relation to the PAAGR restructuring programme, which has a closing provision of $49m (2022: $143m; 2021: $243m), including $8m (2022: $95m; 2021: $158m) held in non-current provisions expected to be settled over time by 2025. In 2022, charges to Other provisions included $301m in relation to termination fees and onerous contracts with contract manufacturing organisations, the vast majority of which was settled in 2023.
No provision has been released or applied for any purpose other than that for which it was established.
1 The profile of future payments of legal provisions due after one year is as follows; in one to two years $180m (2022: $22m; 2021: $14m), in two to three years $159m (2022: $21m; 2021: $17m), in three to four years $10m (2022: $9m; 2021: $22m), in four to five years $9m (2022: $9m; 2021: $9m), and in more than five years $14m (2022: $31m; 2021: $43m).
F-36
22 Post-retirement pension and other defined benefit schemes
Background
This section predominantly covers defined benefit arrangements like post-retirement pension and medical plans which make up the vast bulk of the Group’s liabilities. However, it also incorporates other benefits which fall under IAS 19 rules and which require an actuarial valuation, including but not limited to: lump sum plans, long service awards and defined contribution pension plans which have some defined benefit characteristics (e.g. a minimum guaranteed level of benefit). In total, over 50 plans in 28 countries are covered.
The Group and most of its subsidiaries offer retirement plans which cover the majority of employees. The Group’s policy is to provide defined contribution (DC) orientated pension provision to its employees unless otherwise compelled by local regulation. As a result, many of these retirement plans are DC, where the Group contribution and resulting charge is fixed at a set level or is a set percentage of employees’ pay. However, several plans, mainly in the UK and Sweden, are defined benefit (DB), where benefits are based on employees’ length of service and salary. The major DB plans are largely legacy arrangements as they have been closed to new entrants since 2000, apart from the collectively bargained Swedish plan (which is still open to employees born before 1979). During 2010, following consultation with its UK employees’ representatives, the Group introduced a freeze on pensionable pay at 30 June 2010 levels for DB members of the UK Pension Fund. The number of active members in the Fund continues to decline and is now 400 employees.
The major DB plans are funded through separate, fiduciary-administered assets. The cash funding of the plans, which may from time to time involve payments from the Group, is designed, in consultation with independent qualified actuaries, to ensure that the assets are sufficient to meet future obligations as and when they fall due. The funding level is monitored by the Group and local fiduciaries, who take into account the strength of the Group’s covenant, local regulation, cash flows, and the solvency and maturity of the pension plan.
Financing Principles and Funding Framework
Eighty six per cent of the Group’s total DB obligations (or 66% of net obligations) at 31 December 2023 are in schemes within the UK and Sweden. In these countries, the pension obligations are funded in line with the Group’s financing principles, as disclosed in prior years.
The Group has developed a long-term funding framework to implement these principles. This framework targets either full funding on a low-risk funding measure, or buyout with an external insurer as the pension funds mature, with affordable long-term de-risking of investment strategy along the way. Unless local regulation dictates otherwise, this framework determines the cash contributions payable.
UK
The UK Pension Fund represents approximately 65% of the Group’s DB obligations at 31 December 2023. The financing principles are modified in light of the UK regulatory requirements (summarised below) and resulting discussions with the Trustee.
Role of Trustee and Regulation
The UK Pension Fund is governed and administered by a corporate Trustee which is legally separate from the Group. The Trustee Directors are comprised of representatives appointed by both the employer and employees and include an independent professional Trustee Director. The Trustee Directors are required by law to act in the interest of all relevant beneficiaries and are responsible in particular for investment strategy and the day-to-day administration of the benefits. They are also responsible for jointly agreeing with the employer the level of contributions due to the UK Pension Fund.
The UK pensions industry is regulated by The Pensions Regulator whose statutory objectives and regulatory powers are described on its website, www.thepensionsregulator.gov.uk.
The Pension Scheme Act 2021 became effective in the UK from 1 October 2021. A section of this Act places additional legal requirements on companies who sponsor UK defined benefit pension schemes, to monitor and assess corporate activity, with a focus on the potential impact of such activity on the ongoing security of these benefits. The Group maintains a framework to ensure it meets its responsibilities under the Act.
There have been two UK High Court Rulings relating to Guaranteed Minimum Pensions (GMP) equalisation in 2018 and 2020. Following the publication of guidance around implementation in 2021, the Trustee, with input from the Group, has now completed the equalisation of benefits for the vast majority of pensioner members, with the project expected to complete in 2024. Further details are set out later in this Note. An estimate of the impact of these changes has already been recognised in 2018 and 2020, and actual experience is in line with the estimates previously recognised.
In June 2023, the UK High Court (Virgin Media Limited v NTL Pension Trustees II Limited) ruled that certain historical amendments for contracted-out defined benefit schemes were invalid if they were not accompanied by the correct actuarial confirmation. The judgment is subject to appeal. The Trustee and Group are monitoring developments and will consider if there are any implications for the UK Pension Fund, if the ruling is upheld.
Funding requirements
UK legislation requires that an actuarial valuation is completed for all DB pension schemes every three years, which compares the schemes’ liabilities to its assets. As part of the triennial valuation process, the Trustee and the Group must agree on a set of assumptions to value the liabilities and determine the contributions required, if any, to ensure the UK Pension Fund is fully funded over an appropriate time period and on a suitably prudent measure. The assumptions used to value the liabilities for the triennial actuarial valuation are required to be prudent, whereas the assumptions used to prepare an IAS 19 accounting valuation are required to be ‘best estimate’.
The last full actuarial valuation of the UK Pension Fund was carried out by a qualified actuary as at 31 March 2022 and finalised in May 2023, ahead of the statutory deadline.
Under the funding assumptions used to set the statutory funding target, the key assumptions from the actuarial valuation as at 31 March 2022 (shown as a single-equivalent rate) were as follows: salary increases at 0% per annum (as a result of pensionable pay levels being frozen in 2010); pension increases at 3.64% per annum; and discount rate at 3.03% per annum. The resulting valuation of the Fund’s liabilities on that basis was £5,951m ($7,820m) compared to a market valuation of assets at 31 March 2022 of £5,604m ($7,364m).
Aspects of the triennial actuarial valuation are governed by a long-term funding agreement, effective since October 2016, which sets out a path to full funding on a low-risk measure. Under this agreement, if a deficit exists, the Group is required to provide security. This security takes the form of a charge in favour of the Trustee over all land and buildings on the Group’s Cambridge Biomedical Campus site. This charge was enacted in December 2023, and provides long-term security to the Trustee in respect of the Group’s future deficit recovery contributions. The value of the charge is currently £317m ($404m) and it is capped at £350m ($446m). The value of the charge will vary and is expected to reduce over time, before falling away. Under the terms of the charge, the Trustee can only exercise its right over the ownership of the site in a Group insolvency event.
In relation to deficit recovery contributions, a lump sum contribution of £39m ($48m) was made in March 2023, with a further annual contribution of £39m ($50m) due before 31 March 2024, and each year up to March 2028.
Further progress was made over 2023 in equalising GMP for members of the UK Pension Fund. The method of equalisation converts GMP to non-GMP pension to simplify the structure and administration of benefits. As at 31 December 2023, almost all pensioner and dependent members have had their benefits equalised and, for non-pensioner members, a process will be in place in 2024 to equalise their benefits at their point of retirement.
F-37
As part of the project, a Pension Increase Exchange (‘PiE’) option was also made available to the majority of pensioner members, at the Group’s discretion. This option provided the member with a choice to opt for a higher pension right away, but with no, or fewer, inflation-linked increases in the future. Take-up of this option resulted in a reduction to expected future liabilities and a $16m past service credit was taken to the income statement in March 2023.
Under the governing documentation of the UK Pension Fund, any future surplus in the Fund would be returnable to the Group by refund assuming gradual settlement of the liabilities over the lifetime of the Fund. In particular, the Trustee has no unilateral right to wind up the Fund without Company consent nor does it have the power to unilaterally use surplus to augment benefits prior to wind-up. As such, there are no adjustments required in respect of IFRIC 14 ‘IAS 19 – The Limit on a Defined Benefit Asset, Minimum Funding Requirements and their Interaction’.
On current bases, it is expected that ongoing contributions (excluding those in respect of past service deficit contributions) during the year ending 31 December 2024 for the UK scheme will be approximately $18m.
United States
In May 2023, AstraZeneca Pharmaceuticals LP agreed a buy-out of its qualified US Defined Benefit Pension Plan with an external insurer. All Plan liabilities (approximately $840m) have now been discharged (via a mix of cash payments to participants and purchase of insured annuities), with an impact of $1.7m on the income statement and a net Group cash contribution of approximately $25m. The Plan is wound up and the Trust is closed. The transaction will be completed in 2024, pending approval of Group annuity contracts from State Regulators.
There are three remaining immaterial US post-retirement benefit plans and therefore from 2024, these will not be individually disclosed.
Sweden
The Swedish plans account for 20% of the Group’s defined benefit obligations. They are governed by Fiduciary Bodies with responsibility for the investment of the assets. These plans are funded in line with the Group’s financing principles and local regulations.
The Swedish defined benefit pension plans were actuarially valued at 31 December 2022, when plan obligations were estimated to amount to $1,312m and plan assets were $946m. The local Swedish GAAP funding position can influence contribution policy. Over 2023, for the main pension fund the Group did not request a reimbursement of benefit payments made throughout the year as the funding level was below 100% on the Swedish GAAP basis. The benefit payments over 2023, totalling approximately $47m, are therefore regarded as Group contributions.
On current bases, it is expected that ongoing contributions (excluding those in respect of past service deficit contributions) during the year ending 31 December 2024 for Sweden will be approximately $53m.
Other defined benefit plans
The Group provides benefit plans other than pensions which have to be reported under IAS 19. These include lump sum plans, long service awards and defined contribution pension plans which have a guaranteed minimum benefit. However, the largest category of these ‘other’ non-pension plans are healthcare benefits.
In the US, and to a lesser extent in certain other countries, the Group’s employment practices include the provision of healthcare and life assurance benefits for eligible retired employees. As at 31 December 2023, some 2,673 retired employees and covered dependents currently benefit from these provisions and some 2,133 current employees will be eligible on their retirement. The Group accrues for the present value of such retiree obligations over the working life of the employee. In practice, these benefits will be funded with reference to the financing principles.
In the US, the Post Retirement Welfare Plan which provides retiree medical benefits has a surplus of $66m. As a result, the investment strategy has been fully de-risked. The Group has concluded that under current legislation, the surplus would be repayable in the future to subsidise other medical benefits offered to employees.
The cost of post-retirement benefits other than pensions for the Group in 2023 was $1m (2022: $1m; 2021: $1m). Plan assets were $161m and plan obligations were $114m at 31 December 2023. These benefit plans have been included in the disclosure of post-retirement benefits under IAS 19.
Financial assumptions
Qualified independent actuaries have updated the actuarial valuations under IAS 19 for the major defined benefit schemes operated by the Group to 31 December 2023. The assumptions used may not necessarily be borne out in practice, due to the inherent financial and demographic uncertainty associated with making long-term projections. These assumptions reflect the changes which have the most material impact on the results of the Group and were as follows:
|
|
|
|
|
|
|
|
|
2022 |
|
|
UK |
|
US |
|
Sweden |
|
Rest of Group1 |
|
Inflation assumption |
|
3.2 |
% |
– |
|
1.9 |
% |
2.5 |
% |
Rate of increase in salaries |
|
– |
2 |
– |
|
3.4 |
% |
4.0 |
% |
Rate of increase in pensions in payment |
|
3.1 |
% |
– |
|
1.9 |
% |
2.5 |
% |
Discount rate – defined benefit obligation |
|
4.9 |
% |
5.0 |
% |
4.1 |
% |
3.7 |
% |
Discount rate – interest cost |
|
5.0 |
% |
4.9 |
% |
4.0 |
% |
3.8 |
% |
Discount rate – service cost |
|
4.8 |
% |
n/a |
|
4.0 |
% |
3.7 |
% |
|
|
|
|
|
|
|
|
|
2023 |
|
|
UK |
|
US |
|
Sweden |
|
Rest of Group1 |
|
Inflation assumption |
|
3.1 |
% 3 |
– |
|
1.6 |
% |
2.2 |
% |
Rate of increase in salaries |
|
– |
2 |
– |
|
3.1 |
% |
3.7 |
% |
Rate of increase in pensions in payment |
|
2.9 |
% |
– |
|
1.6 |
% |
2.2 |
% |
Discount rate – defined benefit obligation4 |
|
4.6 |
% |
4.7 |
% |
3.3 |
% |
3.3 |
% |
Discount rate – interest cost5 |
|
4.6 |
% |
4.7 |
% |
3.3 |
% |
3.3 |
% |
Discount rate – service cost5 |
|
4.5 |
% |
n/a |
|
3.3 |
% |
3.3 |
% |
| 1 | Rest of Group reflects the assumptions in Germany as these have the most material impact on the Group. |
The weighted average duration of the post-retirement scheme obligations is approximately 11 years in the UK, 16 years in Sweden and 13 years for the Rest of the Group (including Germany).
Demographic assumptions
The mortality assumptions are based on country-specific mortality tables. These are compared to actual experience and adjusted where sufficient data are available. Additional allowance for future improvements in life expectancy is included for all major schemes where there is credible data to support a continuing trend.
F-38
The table below illustrates life expectancy assumptions at age 65 for male and female members retiring in 2023 and male and female members expected to retire in 2043 (2022: 2022 and 2042 respectively).
|
|
Life expectancy assumption for a male member retiring at age 65 |
|
Life expectancy assumption for a female member retiring at age 65 |
|
||||||||||||
Country |
|
2023 |
|
2043 |
|
2022 |
|
2042 |
|
2023 |
|
2043 |
|
2022 |
|
2042 |
|
UK |
|
22.1 |
|
23.1 |
|
22.2 |
|
23.2 |
|
23.7 |
|
24.8 |
|
23.8 |
|
24.9 |
|
US |
|
22.2 |
|
24.6 |
|
22.0 |
|
23.2 |
|
23.3 |
|
26.2 |
|
23.4 |
|
25.0 |
|
Sweden |
|
21.8 |
|
23.6 |
|
21.8 |
|
23.6 |
|
23.9 |
|
26.0 |
|
23.9 |
|
26.0 |
|
In the UK, the Group adopted the CMI 2022 Mortality Projections Model with a 1% long-term improvement rate. No other demographic assumptions have changed since they were updated in 2022 following the actuarial valuation. The Group has continued to assume that 25% of members (2022: 25%) will transfer out of the defined benefit section of the AstraZeneca Pension Fund at the point of retirement.
In the US and Sweden, the mortality assumptions are unchanged from 2022.
Risks associated with the Group’s defined benefit pension schemes
The UK defined benefit plan accounts for 65% of the Group’s defined benefit obligations and exposes the Group to a number of risks, the most significant of which are:
Risk |
|
Description |
|
Mitigation |
Asset pricing risk |
|
The Defined Benefit Obligation (DBO) is calculated using a discount rate set with reference to AA-rated corporate bond yields; asset returns that differ from the discount rate will create an element of volatility in the solvency ratio. Approximately 45% of the UK Pension Fund is allocated to growth assets. Although these growth assets are expected to outperform AA-rated corporate bonds in the long term, they can lead to volatility and mismatching risk in the short term. The allocation to growth assets is monitored to ensure it remains appropriate given the UK Pension Fund’s long-term objectives. |
|
In order to mitigate investment risk, the Trustee invests in a suitably diversified range of asset classes, return drivers and investment managers. The investment strategy will evolve to further improve the expected risk/return profile as opportunities arise. De-risking of the investment strategy took place over 2023, as the Fund moved ahead of its long-term target, with the benchmark allocation to Growth Assets reducing from 62.5% to 47.5%. The Trustee has hedged approximately 92% of unintended non-sterling, overseas currency risk within the UK Pension Fund assets. |
Interest rate risk |
|
A decrease in corporate bond yields will increase the present value placed on the DBO for accounting purposes. |
|
The interest rate hedge of the UK Pension Fund is predominantly implemented via holding gilts (and gilt repurchase agreements or ‘gilt repo’) of appropriate duration. This hedge protects to a large degree against falls in long-term interest rates and the UK Pension Fund is approximately 98% hedged as a percentage of assets at the end of 2023 (versus target of 100%). Nonetheless, there remain differences in the bonds and instruments held by the UK Pension Fund to hedge interest rate risk on the statutory and long-term funding basis (gilts and gilt repo) and the bonds analysed to set the DBO discount rate on an accounting basis (AA corporate bonds). As such, there remains some mismatching risk on an accounting basis should yields on gilts diverge compared to AA corporate bonds. |
Inflation risk |
|
The majority of the DBO is indexed in line with price inflation (mainly inflation as measured by the UK Retail Price Index (RPI) but also for some members a component of pensions is indexed by the UK Consumer Price Index (CPI)) and higher inflation will lead to higher liabilities (although, in the vast majority of cases, this is capped at an annual increase of 5%, known as Limited Price Indexation or LPI). |
|
The UK Pension Fund holds RPI index-linked gilts and gilt repo. The inflation hedge of the UK Pension Fund protects to some degree against higher-than-expected inflation increases on the DBO (approximately 100% hedged as a percentage of assets at the end of 2023). Over 2023, work was carried out by the Trustee to improve the accuracy of the hedge to LPI linked liabilities. |
Life expectancy |
|
The majority of the UK Pension Fund’s obligations are to provide benefits for the life of the member, so increases in life expectancy will result in an increase in the liabilities. |
|
In 2013 the Trustee entered into a longevity swap to hedge against the risk of increasing life expectancy over the next 75 years. The swap currently covers approximately 8,000 of the UK Pension Fund’s pensioners, equivalent to $2.4bn of Pension fund liability. A one-year increase in life expectancy would result in a $214m increase in pension fund obligations, which would be partially offset by a $108m increase in the value of the longevity swap and hence the pension fund assets. |
Cash flow and liquidity risk |
|
The UK Pension Fund is maturing and cash flow negative. Assets are liquidated to meet benefit outgo and potentially from time to time, to supplement the collateral pool required to post margin for derivative holdings. There is a risk of the Trustee requesting liquidity support from the Group to meet margin calls or expenditure, if the liquidity position of the UK Pension Fund is not effectively monitored and managed. |
|
The Trustee invests in a diversified portfolio of highly liquid assets to manage sequencing risk and operates a collateral management policy, maintaining a minimum liquidity ‘buffer’ above recommended regulatory guidelines, which can be quickly supplemented in an orderly manner. Over 2023, in addition to the Growth and Liability Hedging portfolios, the Trustee allocated 7% of assets to a new, cash flow driven investment portfolio, consisting of investment grade corporate bonds. The purpose of this portfolio is to generate income to help meet the Fund’s benefit outgo. The portfolio is expected to grow over time as further de-risking occurs. |
Other risks
There are a number of other risks of administering the UK Pension Fund which the Trustee manages with Group input. Some of the major risks include counterparty risks from using derivatives (mitigated by using a specialist investment manager to oversee a diversified range of counterparties of high standing and ensuring positions are collateralised daily). Furthermore, there are operational risks (such as paying out the wrong benefits) and legislative risks (such as the UK government introducing new legislation). These are mitigated so far as possible via the governance structure in place which oversees and administers the pension funds.
F-39
The Group’s pension plans in Sweden also manage these key risks, where relevant, in a similar way, with the local fiduciary bodies investing in a diversified manner and employing a framework to hedge interest rate risk where practicable.
Local fiduciary boards are aware of Environmental, Social and Governance (ESG) risks as they pertain to investment policy, and where local regulation allows, have policies in place to monitor and manage such risks and comply with local legislation and disclosure requirements. The Trustee of the UK Pension Fund published its inaugural Task Force for Climate-related Disclosures (TCFD) report in October 2023.
Assets and obligations of defined benefit schemes
The assets and obligations of the defined benefit schemes operated by the Group at 31 December 2023, as calculated in accordance with IAS 19, are shown below. The fair values of the schemes’ assets are not intended to be realised in the short term and may be subject to significant change before they are realised. The present value of the schemes’ obligations is derived from cash flow projections over long periods and is therefore inherently uncertain.
Scheme assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2022 |
|
|
|
|
|
UK |
|
|
|
US |
|
|
|
Sweden |
|
|
|
Rest of Group |
|
|
|
Total |
|
|
|
|
|
Quoted |
|
Unquoted |
|
Quoted |
|
Unquoted |
|
Quoted |
|
Unquoted |
|
Quoted |
|
Unquoted |
|
Quoted |
|
Unquoted |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Government bonds1 |
|
1,931 |
|
– |
|
104 |
|
– |
|
– |
|
– |
|
60 |
|
– |
|
2,095 |
|
– |
|
2,095 |
|
Corporate bonds2 |
|
– |
|
– |
|
622 |
|
– |
|
– |
|
– |
|
11 |
|
– |
|
633 |
|
– |
|
633 |
|
Derivatives3 |
|
– |
|
(608) |
|
(2) |
|
(3) |
|
– |
|
325 |
|
(2) |
|
– |
|
(4) |
|
(286) |
|
(290) |
|
Investment funds: Listed Equities4 |
|
– |
|
265 |
|
– |
|
– |
|
– |
|
– |
|
49 |
|
4 |
|
49 |
|
269 |
|
318 |
|
Investment funds: Absolute Return/Multi Strategy4 |
|
– |
|
1,701 |
|
– |
|
– |
|
– |
|
475 |
|
6 |
|
– |
|
6 |
|
2,176 |
|
2,182 |
|
Investment funds: Corporate Bonds/Credit4 |
|
– |
|
817 |
|
– |
|
– |
|
– |
|
144 |
|
49 |
|
10 |
|
49 |
|
971 |
|
1,020 |
|
Cash and cash equivalents |
|
52 |
|
415 |
|
285 |
|
– |
|
– |
|
2 |
|
– |
|
4 |
|
337 |
|
421 |
|
758 |
|
Other |
|
– |
|
– |
|
– |
|
2 |
|
– |
|
– |
|
1 |
|
311 |
|
1 |
|
313 |
|
314 |
|
Total fair value of scheme assets/(liabilities)5 |
|
1,983 |
|
2,590 |
|
1,009 |
|
(1) |
|
– |
|
946 |
|
174 |
|
329 |
|
3,166 |
|
3,864 |
|
7,030 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
|
|
UK |
|
|
|
US |
|
|
|
Sweden |
|
|
|
Rest of Group |
|
|
|
Total |
|
|
|
|
|
Quoted |
|
Unquoted |
|
Quoted |
|
Unquoted |
|
Quoted |
|
Unquoted |
|
Quoted |
|
Unquoted |
|
Quoted |
|
Unquoted |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Government bonds1 |
|
2,383 |
|
– |
|
61 |
|
– |
|
– |
|
– |
|
51 |
|
– |
|
2,495 |
|
– |
|
2,495 |
|
Corporate bonds2 |
|
373 |
|
– |
|
94 |
|
– |
|
– |
|
– |
|
6 |
|
– |
|
473 |
|
– |
|
473 |
|
Derivatives3 |
|
– |
|
(532) |
|
– |
|
– |
|
– |
|
440 |
|
– |
|
– |
|
– |
|
(92) |
|
(92) |
|
Investment funds: Listed Equities4 |
|
– |
|
321 |
|
– |
|
– |
|
– |
|
– |
|
53 |
|
3 |
|
53 |
|
324 |
|
377 |
|
Investment funds: Absolute Return/Multi Strategy4 |
|
– |
|
1,131 |
|
– |
|
– |
|
– |
|
461 |
|
5 |
|
8 |
|
5 |
|
1,600 |
|
1,605 |
|
Investment funds: Corporate Bonds/Credit4 |
|
– |
|
667 |
|
– |
|
– |
|
– |
|
165 |
|
48 |
|
– |
|
48 |
|
832 |
|
880 |
|
Cash and cash equivalents |
|
53 |
|
363 |
|
5 |
|
– |
|
– |
|
2 |
|
– |
|
3 |
|
58 |
|
368 |
|
426 |
|
Other |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
(1) |
|
316 |
|
(1) |
|
316 |
|
315 |
|
Total fair value of scheme assets5 |
|
2,809 |
|
1,950 |
|
160 |
|
– |
|
– |
|
1,068 |
|
162 |
|
330 |
|
3,131 |
|
3,348 |
|
6,479 |
|
| 1 | Predominantly developed markets in nature. |
| 2 | Predominantly developed markets in nature and investment grade (AAA-BBB). |
| 3 | Includes interest rate swaps, inflation swaps, longevity swap, equity total return swaps and other contracts. More detail is given in the section Risks associated with the Group’s defined benefit pensions on page 187. Valuations are determined by independent third parties. |
| 4 | Investment Funds are pooled, commingled vehicles, whereby the pension scheme owns units in the fund, alongside other investors. The pension schemes invest in a number of Investment Funds, including Listed Equities (primarily developed markets with some emerging markets), Corporate Bonds/Credit (a range of investment-grade and non investment-grade credit) and Absolute Return/Multi Strategy (multi-asset exposure both across and within traditional and alternative asset classes). The price of the funds is set by independent administrators/custodians employed by the investment managers and based on the value of the underlying assets held in the fund. Details of pricing methodology is set out within internal control reports provided for each fund. Prices are updated daily, weekly or monthly depending upon the frequency of the fund’s dealing. |
| 5 | None of the Group’s own assets were included in the scheme assets (2022: $1m). The assets held in 2022 were AstraZeneca corporate debt held by the US qualified plan and amounted to 0.05% of the plan's then assets. |
Scheme obligations
|
|
|
|
|
|
|
|
|
|
2022 |
|
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
Present value of scheme obligations in respect of: |
|
|
|
|
|
|
|
|
|
|
Active membership |
|
(212) |
|
(54) |
|
(430) |
|
(424) |
|
(1,120) |
Deferred membership |
|
(804) |
|
(437) |
|
(369) |
|
(299) |
|
(1,909) |
Pensioners |
|
(3,785) |
|
(531) |
|
(513) |
|
(250) |
|
(5,079) |
Total value of scheme obligations |
|
(4,801) |
|
(1,022) |
|
(1,312) |
|
(973) |
|
(8,108) |
|
|
|
|
|
|
|
|
|
|
2023 |
|
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
Present value of scheme obligations in respect of: |
|
|
|
|
|
|
|
|
|
|
Active membership |
|
(233) |
|
(45) |
|
(553) |
|
(442) |
|
(1,273) |
Deferred membership |
|
(853) |
|
(2) |
|
(443) |
|
(294) |
|
(1,592) |
Pensioners |
|
(4,075) |
|
(107) |
|
(606) |
|
(254) |
|
(5,042) |
Total value of scheme obligations |
|
(5,161) |
|
(154) |
|
(1,602) |
|
(990) |
|
(7,907) |
F-40
Net (deficit)/surplus in the scheme
|
|
|
|
|
|
|
|
|
2022 |
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
Total fair value of scheme assets |
4,573 |
|
1,008 |
|
946 |
|
503 |
|
7,030 |
Total value of scheme obligations |
(4,801) |
|
(1,022) |
|
(1,312) |
|
(973) |
|
(8,108) |
Deficit in the scheme as recognised in the |
(228) |
|
(14) |
|
(366) |
|
(470) |
|
(1,078) |
Included in Non-current other receivables |
– |
|
62 |
|
– |
|
28 |
1 |
90 |
Included in Retirement benefit obligations |
(228) |
|
(76) |
|
(366) |
|
(498) |
|
(1,168) |
|
(228) |
|
(14) |
|
(366) |
|
(470) |
|
(1,078) |
|
|
|
|
|
|
|
|
|
2023 |
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
Total fair value of scheme assets |
4,759 |
|
160 |
|
1,068 |
|
492 |
|
6,479 |
Total value of scheme obligations |
(5,161) |
|
(154) |
|
(1,602) |
|
(990) |
|
(7,907) |
(Deficit)/surplus in the scheme as recognised in the Consolidated Statement of Financial Position |
(402) |
|
6 |
|
(534) |
|
(498) |
|
(1,428) |
Included in Non-current other receivables |
– |
|
66 |
|
– |
|
26 |
1 |
92 |
Included in Retirement benefit obligations |
(402) |
|
(60) |
|
(534) |
|
(524) |
|
(1,520) |
|
(402) |
|
6 |
|
(534) |
|
(498) |
|
(1,428) |
| 1 | Surpluses were recognised in Ireland and Belgium. |
Fair value of scheme assets
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
2022 |
|
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
At beginning of year |
4,573 |
|
1,008 |
|
946 |
|
503 |
|
7,030 |
|
7,333 |
|
1,413 |
|
1,234 |
|
584 |
|
10,564 |
|
Interest income on scheme assets |
229 |
|
22 |
|
38 |
|
11 |
|
300 |
|
123 |
|
29 |
|
18 |
|
5 |
|
175 |
|
Expenses |
(9) |
|
(1) |
|
– |
|
(1) |
|
(11) |
|
(5) |
|
(2) |
|
– |
|
– |
|
(7) |
|
Actuarial (losses)/gains |
(59) |
|
2 |
|
37 |
|
(45) |
|
(65) |
|
(1,964) |
|
(295) |
|
(153) |
|
(55) |
|
(2,467) |
|
Exchange and other adjustments |
262 |
|
(1) |
|
48 |
|
20 |
|
329 |
|
(728) |
|
– |
|
(152) |
|
(34) |
|
(914) |
|
Employer contributions |
65 |
|
35 |
|
46 |
|
42 |
|
188 |
|
118 |
|
7 |
|
43 |
|
37 |
|
205 |
|
Participant contributions |
1 |
|
4 |
|
– |
|
7 |
|
12 |
|
1 |
|
5 |
|
– |
|
5 |
|
11 |
|
Benefits paid |
(303) |
|
(68) |
|
(47) |
|
(45) |
|
(463) |
|
(305) |
|
(149) |
|
(44) |
|
(39) |
|
(537) |
|
Settlements |
– |
|
(841) |
|
– |
|
– |
|
(841) |
|
– |
|
– |
|
– |
|
– |
|
– |
|
Scheme assets’ fair value at end of year |
4,759 |
|
160 |
|
1,068 |
|
492 |
|
6,479 |
|
4,573 |
|
1,008 |
|
946 |
|
503 |
|
7,030 |
|
The actual return on the plan assets was a gain of $235m (2022: loss of $2,292m).
Movement in post-retirement scheme obligations
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
2022 |
|
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Present value of obligations in scheme at beginning of year |
(4,801) |
|
(1,022) |
|
(1,312) |
|
(973) |
|
(8,108) |
|
(7,941) |
|
(1,404) |
|
(2,373) |
|
(1,300) |
|
(13,018) |
|
Current service cost |
(6) |
|
(2) |
|
(13) |
|
(35) |
|
(56) |
|
(14) |
|
(1) |
|
(35) |
|
(38) |
|
(88) |
|
Past service credit/(cost) |
12 |
|
– |
|
(2) |
|
2 |
|
12 |
|
(5) |
|
– |
|
(4) |
|
3 |
|
(6) |
|
Participant contributions |
(1) |
|
(4) |
|
– |
|
(7) |
|
(12) |
|
(1) |
|
(4) |
|
– |
|
(5) |
|
(10) |
|
Benefits paid |
303 |
|
68 |
|
47 |
|
45 |
|
463 |
|
305 |
|
149 |
|
44 |
|
39 |
|
537 |
|
Interest expense on post-retirement scheme obligations |
(239) |
|
(22) |
|
(50) |
|
(27) |
|
(338) |
|
(132) |
|
(29) |
|
(31) |
|
(12) |
|
(204) |
|
Actuarial (losses)/gains |
(155) |
|
(12) |
|
(202) |
|
28 |
|
(341) |
|
2,243 |
|
268 |
|
806 |
|
268 |
|
3,585 |
|
Exchange and other adjustments |
(274) |
|
1 |
|
(70) |
|
(34) |
|
(377) |
|
744 |
|
(1) |
|
281 |
|
72 |
|
1,096 |
|
Settlements |
– |
|
839 |
|
– |
|
11 |
|
850 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
Present value of obligations in scheme at end of year |
(5,161) |
|
(154) |
|
(1,602) |
|
(990) |
|
(7,907) |
|
(4,801) |
|
(1,022) |
|
(1,312) |
|
(973) |
|
(8,108) |
|
The obligations arise from over 50 plans in 28 countries:
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
2022 |
|
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Funded – pension schemes1 |
(5,151) |
|
– |
|
(1,599) |
|
(868) |
|
(7,618) |
|
(4,787) |
|
(851) |
|
(1,310) |
|
(842) |
|
(7,790) |
|
Funded – post-retirement healthcare |
– |
|
(94) |
|
– |
|
– |
|
(94) |
|
– |
|
(111) |
|
– |
|
– |
|
(111) |
|
Unfunded – pension schemes1 |
– |
|
(60) |
|
(3) |
|
(113) |
|
(176) |
|
– |
|
(60) |
|
(2) |
|
(122) |
|
(184) |
|
Unfunded – post-retirement healthcare |
(10) |
|
– |
|
– |
|
(9) |
|
(19) |
|
(14) |
|
– |
|
– |
|
(9) |
|
(23) |
|
Total |
(5,161) |
|
(154) |
|
(1,602) |
|
(990) |
|
(7,907) |
|
(4,801) |
|
(1,022) |
|
(1,312) |
|
(973) |
|
(8,108) |
|
| 1 | Includes defined benefit pension schemes and other plans, such as lump sum, long service awards and DC plans with underpins. |
F-41
Consolidated Statement of Comprehensive Income disclosures
The amounts that have been charged to the Consolidated Statement of Comprehensive Income, in respect of defined benefit schemes for the year ended 31 December 2023, are set out below.
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
2022 |
|
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
UK |
|
US |
|
Sweden |
|
Rest of Group |
|
Total |
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Operating profit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current service cost |
(6) |
|
(2) |
|
(13) |
|
(35) |
|
(56) |
|
(14) |
|
(1) |
|
(35) |
|
(38) |
|
(88) |
|
Past service credit/(cost) |
12 |
|
– |
|
(2) |
|
2 |
|
12 |
|
(5) |
|
– |
|
(4) |
|
3 |
|
(6) |
|
Expenses |
(9) |
|
(1) |
|
– |
|
(1) |
|
(11) |
|
(5) |
|
(2) |
|
– |
|
– |
|
(7) |
|
Total charge to Operating profit |
(3) |
|
(3) |
|
(15) |
|
(34) |
|
(55) |
|
(24) |
|
(3) |
|
(39) |
|
(35) |
|
(101) |
|
Finance expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income on scheme assets |
229 |
|
22 |
|
38 |
|
11 |
|
300 |
|
123 |
|
29 |
|
18 |
|
5 |
|
175 |
|
Interest expense on post-retirement scheme obligations |
(239) |
|
(22) |
|
(50) |
|
(27) |
|
(338) |
|
(132) |
|
(29) |
|
(31) |
|
(12) |
|
(204) |
|
Net interest on post-employment defined benefit plan liabilities |
(10) |
|
– |
|
(12) |
|
(16) |
|
(38) |
|
(9) |
|
– |
|
(13) |
|
(7) |
|
(29) |
|
Charge before taxation |
(13) |
|
(3) |
|
(27) |
|
(50) |
|
(93) |
|
(33) |
|
(3) |
|
(52) |
|
(42) |
|
(130) |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Difference between the actual return and the expected return on the post-retirement scheme assets |
(59) |
|
2 |
|
37 |
|
(45) |
|
(65) |
|
(1,964) |
|
(295) |
|
(153) |
|
(55) |
|
(2,467) |
|
Experience (losses)/gains arising on the post-retirement scheme obligations |
(25) |
|
(2) |
|
(67) |
|
(13) |
|
(107) |
|
55 |
|
(16) |
|
(99) |
|
(6) |
|
(66) |
|
Changes in financial assumptions underlying the present value of the post-retirement scheme obligations |
(142) |
|
(10) |
|
(135) |
|
44 |
|
(243) |
|
2,272 |
|
284 |
|
896 |
|
275 |
|
3,727 |
|
Changes in demographic assumptions |
12 |
|
– |
|
– |
|
(3) |
|
9 |
|
(84) |
|
– |
|
9 |
|
(1) |
|
(76) |
|
Remeasurement of the defined benefit liability |
(214) |
|
(10) |
|
(165) |
|
(17) |
|
(406) |
|
279 |
|
(27) |
|
653 |
|
213 |
|
1,118 |
|
Past service cost includes granting early retirement in UK and Sweden.
Total Group pension costs in respect of defined contribution and defined benefit schemes during the year are set out below (see Note 29).
|
|
|
|
2023 |
|
2022 |
|
|
|
|
|
$m |
|
$m |
|
Defined contribution schemes |
|
|
|
482 |
|
445 |
|
Defined benefit schemes − Current service cost and Expenses |
|
|
|
67 |
|
95 |
|
Defined benefit schemes − Past service (credit)/cost |
|
|
|
(12) |
|
6 |
|
Pension costs |
|
|
|
537 |
|
546 |
|
Rate sensitivities
The following table shows the US dollar effect of a change in the significant actuarial assumptions used to determine the retirement benefits obligations in our three main defined benefit pension obligation countries.
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
+0.5% |
|
−0.5% |
|
+0.5% |
|
−0.5% |
|
Discount rate |
|
|
|
|
|
|
|
|
|
UK ($m) |
|
269 |
|
(308) |
|
262 |
|
(289) |
|
US ($m) |
|
4 |
|
(4) |
|
46 |
|
(49) |
|
Sweden ($m) |
|
109 |
|
(123) |
|
95 |
|
(107) |
|
Total ($m) |
|
382 |
|
(435) |
|
403 |
|
(445) |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
+0.5% |
|
−0.5% |
|
+0.5% |
|
−0.5% |
|
Inflation rate1 |
|
|
|
|
|
|
|
|
|
UK ($m) |
|
(189) |
|
184 |
|
(173) |
|
165 |
|
US ($m) |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
Sweden ($m) |
|
(116) |
|
104 |
|
(104) |
|
93 |
|
Total ($m) |
|
(305) |
|
288 |
|
(277) |
|
258 |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
+0.5% |
|
−0.5% |
|
+0.5% |
|
−0.5% |
|
Rate of increase in salaries |
|
|
|
|
|
|
|
|
|
UK ($m) |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
US ($m) |
|
n/a |
|
n/a |
|
n/a |
|
n/a |
|
Sweden ($m) |
|
(46) |
|
42 |
|
(47) |
|
43 |
|
Total ($m) |
|
(46) |
|
42 |
|
(47) |
|
43 |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
+1 year |
|
−1 year |
|
+1 year |
|
−1 year |
|
Mortality rate |
|
|
|
|
|
|
|
|
|
UK ($m) |
|
(214) |
2 |
212 |
3 |
(191) |
|
193 |
|
US ($m) |
|
(2) |
|
2 |
|
(20) |
|
20 |
|
Sweden ($m) |
|
(51) |
|
51 |
|
(44) |
|
44 |
|
Total ($m) |
|
(267) |
|
265 |
|
(255) |
|
257 |
|
| 1 | Rate of increase in pensions in payment follows inflation. |
| 2 | Of the $214m increase, $108m is covered by the longevity swap. |
F-42
| 3 | Of the $212m decrease, $106m is covered by the longevity swap. |
In consideration of current market conditions, additional sensitivities have been calculated for the UK and Sweden schemes for 2023. The effect on retirement benefit obligations of a 1.0% change in assumption is as follows: $525m (UK) and $210m (Sweden) if the discount rate is increased; $(634)m (UK) and $(254)m (Sweden) if the discount rate is decreased; $(384)m (UK) and $(240)m (Sweden) if the inflation rate is increased; and $363m (UK) and $201m (Sweden) if the inflation rate is decreased.
The sensitivity to the financial assumptions shown above has been estimated taking into account the approximate duration of the liabilities and the overall profile of the plan membership.
The inflation sensitivity allows for the impact of a change in inflation on salary increases and pension increases (where these assumptions are inflation-linked).
The salary increase sensitivity reflects the impact of an increase of only salary relative to inflation.
The sensitivity to the life expectancy assumption is estimated based on a revised mortality assumption that extends/reduces the current life expectancy by one year for a particular age.
23 Reserves
Retained earnings
The cumulative amount of goodwill written off directly to reserves resulting from acquisitions, net of disposals, amounted to $595m (2022: $591m; 2021: $615m) using year end rates of exchange.
At 31 December 2023, 1,580,137 shares, at a cost of $129m, have been deducted from Retained earnings (2022: 1,671,446 shares, at a cost of $112m; 2021: 3,922,122 shares, at a cost of $239m) to satisfy future vesting of employee share plans.
There are no significant statutory or contractual restrictions on the distribution of current profits of subsidiaries; undistributed profits of prior years are, in the main, permanently employed in the businesses of these companies. The undistributed income of AstraZeneca companies overseas might be liable to overseas taxes and/or UK taxation (after allowing for double taxation relief) if they were to be distributed as dividends (see Note 4).
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Cumulative translation differences included within Retained earnings |
|
|
|
|
|
|
|
At 1 January |
|
(3,694) |
|
(1,934) |
|
(1,143) |
|
Foreign exchange arising on consolidation |
|
608 |
|
(1,446) |
|
(483) |
|
Exchange adjustments on goodwill (recorded against other reserves) |
|
4 |
|
(24) |
|
(21) |
|
Foreign exchange arising on designated liabilities in net investment hedges1 |
|
24 |
|
(282) |
|
(321) |
|
Fair value movements on derivatives designated in net investment hedges |
|
44 |
|
(8) |
|
34 |
|
Net exchange movement in Retained earnings |
|
680 |
|
(1,760) |
|
(791) |
|
At 31 December |
|
(3,014) |
|
(3,694) |
|
(1,934) |
|
| 1 | Foreign exchange arising on designated liabilities in net investment hedges includes $(57)m in respect of designated bonds and $81m in respect of designated contingent consideration and other liabilities. The change in value of designated contingent consideration liabilities relates to $82m in respect of BMS’ share of Global Diabetes Alliance. |
The cumulative loss with respect to costs of hedging is $22m (2022: loss of $3m; 2021: gain of $4m) and the loss during the year was $19m (2022: loss of $7m; 2021: loss of $6m).
The balance remaining in the foreign currency translation reserve from net investment hedging relationships for which hedge accounting no longer applied is a gain of $527m. For further detail relating to hedging balances, please see the Hedge accounting section within Note 28, from page 200.
Other reserves
The other reserves arose from the cancellation of £1,255m of share premium account by the Company in 1993 and the redenomination of share capital of $157m in 1999. The reserves are available for writing off goodwill arising on consolidation and, subject to guarantees given to preserve creditors at the date of the court order, are available for distribution.
24 Share capital
|
|
|
|
Allotted, called-up and fully paid |
|
||
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Issued Ordinary Shares ($0.25 each) |
|
388 |
|
387 |
|
387 |
|
Redeemable Preference Shares (£1 each – £50,000) |
|
– |
|
– |
|
– |
|
At 31 December |
|
388 |
|
387 |
|
387 |
|
The Redeemable Preference Shares carry limited class voting rights and no dividend rights. This class of shares is capable of redemption at par at the option of the Company on the giving of seven days’ written notice to the registered holder of the shares.
The Company does not have a limited amount of authorised share capital.
The movements in the number of Ordinary Shares during the year can be summarised as follows:
|
|
|
|
|
|
No. of shares |
|
|
|
2023 |
|
2022 |
|
2021 |
|
At 1 January |
|
1,549,800,030 |
|
1,549,400,665 |
|
1,312,668,724 |
|
Issue of share capital (business combinations) |
|
– |
|
– |
|
236,321,411 |
|
Issue of shares (share schemes) |
|
362,596 |
|
399,365 |
|
410,530 |
|
At 31 December |
|
1,550,162,626 |
|
1,549,800,030 |
|
1,549,400,665 |
|
Share issues
Issue of share capital (business combinations) represents share capital issued as part of the acquisition of Alexion (see Note 27).
Share repurchases
No Ordinary Shares were repurchased by the Company in 2023 (2022: nil; 2021: nil).
F-43
Shares held by subsidiaries
No shares in the Company were held by subsidiaries in any year.
25 Dividends to shareholders
|
|
|
2023 |
|
|
2022 |
|
|
2021 |
|
2023 |
|
2022 |
|
2021 |
|
|
|
|
Per share |
|
|
Per share |
|
|
Per share |
|
$m |
|
$m |
|
$m |
|
Second interim (March 2023) |
|
|
$1.97 |
|
|
$1.97 |
|
|
$1.90 |
|
3,047 |
|
3,046 |
|
2,490 |
|
First interim (September 2023) |
|
|
$0.93 |
|
|
$0.93 |
|
|
$0.90 |
|
1,440 |
|
1,440 |
|
1,392 |
|
Total |
|
|
$2.90 |
|
|
$2.90 |
|
|
$2.80 |
|
4,487 |
|
4,486 |
|
3,882 |
|
The Company has exercised its authority in accordance with the provisions set out in the Company’s Articles of Association, that the balance of unclaimed dividends outstanding past 12 years be forfeited. Unclaimed dividends of $nil (2022: $1m; 2021: $nil) have been adjusted for in Retained earnings in 2023.
The 2022 second interim dividend of $1.97 per share was paid on 27 March 2023. The 2023 first interim dividend of $0.93 per share was paid on 11 September 2023.
Reconciliation of dividends charged to equity to cash flow statement:
|
|
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
|
$m |
|
$m |
|
$m |
Dividends charged to equity |
|
|
|
4,487 |
|
4,486 |
|
3,882 |
Exchange losses on payment of dividend |
|
|
|
5 |
|
5 |
|
3 |
Hedge contracts relating to payment of dividends (cash flow statement) |
|
|
|
(19) |
|
(127) |
|
(29) |
Dividends paid to non-controlling interests |
|
|
|
4 |
|
– |
|
– |
Net movement of unclaimed dividends in the year |
|
|
|
4 |
|
– |
|
– |
Dividends paid (cash flow statement) |
|
|
|
4,481 |
|
4,364 |
|
3,856 |
26 Non-controlling interests
The Group Financial Statements at 31 December 2023 reflect equity of $23m (2022: $21m; 2021: $19m) and total comprehensive income of $6m (2022: $2m; 2021: $3m) attributable to the non-controlling interests in AstraZeneca Pharma India Limited, P.T. AstraZeneca Indonesia, Beijing Falikang Pharmaceutical (China) Co. Limited, and AstraZeneca Algeria Pharmaceutical Industries SPA.
In February 2016, AstraZeneca acquired a 55% controlling stake in Acerta Pharma where the non-controlling interest was subject to put and call options. The put option gave rise to a liability (see Note 20). AstraZeneca exercised its option to acquire the remaining 45% of shares in Acerta Pharma in April 2021.
As part of the acquisition of Alexion in July 2021, a pre-existing non-controlling interest in Caelum Biosciences was recognised (Note 27). This was valued at $150m, the agreed-upon exercise price for the exclusive option to acquire the remaining equity. The option was exercised on 28 September 2021 and the acquisition of Caelum Biosciences closed shortly thereafter on 5 October 2021.
27 Acquisition of business operations
Acquisitions of business operations in 2023
On 16 January 2023, AstraZeneca completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts). The purchase price allocation exercise has completed, with the fair value of total consideration determined at $267m. Intangible assets of $100m and goodwill of $158m were recognised in the acquisition balance sheet, as well as a cash outflow of $189m net of cash acquired. Future contingent milestones-based and non-contingent consideration is payable to a maximum of $120m. Neogene’s results have been consolidated into the Group’s results from 16 January 2023.
Acquisitions of business operations in 2022
On 16 November 2022, AstraZeneca completed the acquisition of 100% of the issued shares of LogicBio Therapeutics, Inc. (LogicBio) based in Lexington, MA, US. LogicBio is a clinical-stage genetic medicine company pioneering genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The total consideration was $72m. Cash of $68m was paid on the completion date, with $4m of outstanding options, which will be settled in cash, recorded in current Trade and other payables. Goodwill of $15m, assets of $82m, including $46m of intangible assets, and liabilities of $25m were recognised on acquisition. LogicBio’s results have been consolidated into the Group’s results from 16 November 2022.
Acquisitions of business operations in 2021
On 21 July 2021, AstraZeneca completed the acquisition of 100% of the issued shares of Alexion Pharmaceuticals, Inc (Alexion), based in Boston, MA, US. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialisation of life-changing medicines.
At closing, Alexion shareholders received 2.1243 AstraZeneca American Depositary Shares (ADSs) and $60 in cash for each of their Alexion shares. Unvested Alexion employee share awards were converted to equivalent AstraZeneca share awards. The fair value of the purchase consideration was $41,058m, comprising AstraZeneca ADSs of $27,196m, cash of $13,349m and replacement employee share awards of $513m.
The Group funded the cash element of the acquisition with $8bn of new long-term debt, issued in May and June 2021, $4bn of term loans drawn in July 2021 under the $17.5bn committed bank facilities entered into in December 2020 to secure the acquisition financing, and existing cash balances. The Group cancelled the remaining $13.5bn of the facilities in June, July and October 2021. Loans and borrowings of $2.3bn acquired with Alexion were repaid in full shortly following completion of the acquisition.
The acquisition was accounted for as a business combination using the acquisition method of accounting in accordance with IFRS 3 ‘Business Combinations’ and consequently the Alexion assets acquired, and liabilities assumed, were recorded by AstraZeneca at fair value, with the excess of the purchase price over the fair value of the identifiable assets and liabilities being recognised as goodwill.
F-44
As part of the Alexion acquisition in 2021, we identified the assets (comprising principally launched products and IPR&D post pre-clinical stage) and liabilities acquired. Attributing fair values to assets acquired and liabilities assumed as part of business combinations is considered to be a key judgement. The purchase price allocation was performed with assistance from an independent valuer to advise on the valuation techniques and key assumptions in the valuation, in particular in respect of the valuation of the intangible assets and inventory.
The fair values assigned to the Alexion business combination in 2021 were:
|
|
|
|
|
|
Fair value |
|
|
|
|
|
|
|
$m |
|
Non-current assets |
|
|
|
|
|
|
|
Property, plant and equipment |
|
|
|
|
|
1,135 |
|
Right-of-use assets |
|
|
|
|
|
263 |
|
Intangible assets |
|
|
|
|
|
26,855 |
|
Other non-current assets |
|
|
|
|
|
301 |
|
|
|
|
|
|
|
28,554 |
|
Current assets |
|
|
|
|
|
|
|
Inventories |
|
|
|
|
|
6,769 |
|
Trade and other receivables |
|
|
|
|
|
2,096 |
|
Intangible assets |
|
|
|
|
|
100 |
|
Cash and cash equivalents |
|
|
|
|
|
4,086 |
|
|
|
|
|
|
|
13,051 |
|
Current liabilities |
|
|
|
|
|
|
|
Interest-bearing loans and borrowings |
|
|
|
|
|
(2,336) |
|
Trade and other payables |
|
|
|
|
|
(1,192) |
|
Other current liabilities |
|
|
|
|
|
(40) |
|
|
|
|
|
|
|
(3,568) |
|
Non-current liabilities |
|
|
|
|
|
|
|
Lease liabilities |
|
|
|
|
|
(228) |
|
Deferred tax liabilities |
|
|
|
|
|
(4,191) |
|
Other non-current liabilities |
|
|
|
|
|
(697) |
|
|
|
|
|
|
|
(5,116) |
|
Total net assets acquired |
|
|
|
|
|
32,921 |
|
Less: non-controlling interests |
|
|
|
|
|
(150) |
|
Goodwill |
|
|
|
|
|
8,287 |
|
Total fair value of consideration |
|
|
|
|
|
41,058 |
|
Less: fair value of equity consideration |
|
|
|
|
|
(27,196) |
|
Less: fair value of replacement employee share awards |
|
|
|
|
|
(513) |
|
Less: cash and cash equivalents acquired |
|
|
|
|
|
(4,086) |
|
Net cash outflow |
|
|
|
|
|
9,263 |
|
The estimated fair value and useful lives of intangible assets were as follows:
|
|
|
|
Fair value |
|
Useful lives |
|
|
|
|
|
$m |
|
Years |
|
Launched products – C5 franchise (Soliris/Ultomiris) |
|
|
|
18,480 |
|
6 to 15 |
|
Launched products – Strensiq, Kanuma, Andexxa |
|
|
|
5,215 |
|
11 to 17 |
|
Products in development |
|
|
|
2,760 |
|
Not amortised |
|
Other intangibles |
|
|
|
500 |
|
5 to 10 |
|
|
|
|
|
26,955 |
|
|
|
The fair value attributed to intangible assets was $26,955m and primarily represents intellectual property rights over launched products of $23,695m and products under development of $2,760m. These were fair valued using the multi-period excess earnings method, which uses a number of estimates regarding the amount and timing of future cash flows. The key assumptions in the cash flows are the probability of technical and regulatory success, peak year sales and revenue erosion curves. In accordance with the Group’s policy on impairment assessments as set out on page 159, the assets were assessed for impairment in the final quarter of 2023, 2022 and 2021. Future milestones have been included in the valuation of the intangible assets (as a deduction of cash flows).
The fair value of inventory, which includes raw materials, work in progress and finished goods related to the launched products was estimated at $6,769m, an uplift of $5,635m on the carrying value prior to the acquisition. The fair value adjustment relates only to work in progress and finished goods and was calculated as the estimated selling price less costs to complete and sell the inventory, associated margins on these activities and holding costs. As at 31 December 2023, the fair value uplift has been fully unwound.
Property, plant and equipment principally comprises the manufacturing facilities in Dublin and Athlone, Ireland and was fair valued using a cost approach. The estimated fair value of $1,135m represents an uplift of $111m over carrying value.
The estimated fair value of contingent liabilities was $76m, relating to various claims and disputes in each case where there is a possible, but not probable, future financial exposure, and involve an assessment of the likelihood of a number of scenarios in relation to those matters. This amount has been included within other non-current liabilities of $697m.
The estimated fair value of trade and other receivables was $2,096m, which approximated the contractual cash flows.
The net deferred tax position reflected an adjustment of $5,215m related to the deferred tax impact of the fair value uplifts on intangible assets, inventories, property, plant and equipment and contingent liabilities as described above.
Goodwill amounting to $8,287m was recognised on acquisition and is underpinned by a number of elements, which individually could not be quantified. Most significant among these is the premium attributable to a pre-existing, well-positioned business in the innovation-intensive, high-growth rare diseases market with a highly skilled workforce and established reputation.
F-45
Other important elements include the potential unidentified products that future research and development may yield and the core technological capabilities and knowledge base of the company. Goodwill is not expected to be deductible for tax purposes.
Non-controlling interests reflect Alexion’s pre-existing minority equity interest in Caelum Biosciences and have been valued at $150m, the agreed-upon exercise price for the exclusive option to acquire the remaining equity. The option was exercised on 28 September 2021 and the acquisition of Caelum Biosciences closed shortly thereafter on 5 October 2021 (Note 26).
Alexion’s results have been consolidated into the Group’s results from 21 July 2021. For the period from acquisition to 31 December 2021, before reflecting the fair value adjustments arising on the acquisition, Alexion’s Total Revenues were $3,071m and Profit after tax was $889m. If the acquisition had taken effect at the beginning of the reporting period in which the acquisition occurred (1 January 2021), on a pro forma basis, after reflecting the fair value adjustments arising on the acquisition, the Total Revenue of the combined Group for the year ended 31 December 2021 would have been $41,132m and the Loss after tax would have been $1,152m. This pro forma information does not purport to represent the results of the combined Group that actually would have occurred had the acquisition taken place on 1 January 2021 and should not be taken to be representative of future results.
Total acquisition-related costs of $5m (2022: $4m; 2021: $171m) have been incurred by the Group, which include advisory, legal and other professional fees. These costs are presented in the Statement of Comprehensive Income within Selling, general and administrative expense and Finance expense.
The terms of the acquisition include a retention bonus plan for legacy Alexion employees whereby up to $50m may be used for retention bonus awards to employees at the level of Vice President or below. In 2023, $nil costs were recorded in the Statement of Comprehensive Income (2022: $3m; 2021: $24m). These bonuses vested and were paid six months after the acquisition, or earlier.
Upon completion of the acquisition, all unvested Alexion employee share awards were converted into AstraZeneca restricted stock awards that continue to have, and shall be subject to, the same terms and conditions as applied in the corresponding Alexion awards immediately prior to completion. Alexion Performance Stock Plan (PSU) awards that included performance-based vesting conditions were converted using the greater of the original target level and Alexion's assessment of the level of achievement immediately prior to completion (subject to a limit of 175% for the awards granted in 2019 and a limit of 150% for the awards granted in 2020). In the year, a cost of $48m (2022: $257m; 2021: $257m) has been recorded in the Statement of Comprehensive Income, $nil (2022: $9m; 2021: $9m) in Cost of sales, $16m (2022: $92m; 2021: $73m) in Research and development expense and $32m (2022: $156m; 2021: $175m) in Selling, general and administrative expense. Payments made to the Employee Benefit Trust upon vesting of share awards recognised as part of the consideration for the acquisition of Alexion are recognised within investing activities in the Group’s Statement of Cash Flows as the cash payment relates to the settlement of the obligation that arose on the acquisition of Alexion that was included as part of the consideration for the acquisition.
28 Financial risk management objectives and policies
The Group’s principal financial instruments, other than derivatives, comprise bank overdrafts, loans and other borrowings, lease liabilities, current and non-current investments, cash and short-term deposits. The main purpose of these financial instruments is to manage the Group’s funding and liquidity requirements. The Group has other financial assets and liabilities such as trade receivables and trade payables, which arise directly from its operations.
The principal financial risks to which the Group is exposed are those of liquidity, interest rate, foreign currency and credit. Each of these is managed in accordance with Board-approved policies. These policies, together with the Group's approach to capital management, are set out below.
Capital management
The capital structure of the Group consists of Shareholders’ equity (Note 24), Debt (Note 19), Other current investments (Note 12) and Cash (Note 17). For the foreseeable future, the Board will maintain a capital structure that supports the Group’s strategic objectives through:
| > | managing funding and liquidity risk |
| > | optimising shareholder return |
| > | maintaining a strong, investment-grade credit rating. |
The Group utilises factoring arrangements and bank acceptance drafts discounting for selected trade receivables. These arrangements qualify for full derecognition of the associated trade receivables under IFRS 9. Amounts due on invoices that have not been factored at year end, from customers that are subject to these arrangements, are disclosed in Note 16.
Funding and liquidity risk are reviewed regularly by the Board and managed in accordance with the policies described below.
The Board regularly reviews its shareholders’ distribution policy, which comprises a regular cash dividend and potentially a share repurchase component. No share repurchases have been made since 2012.
The Group’s net debt position (loans and borrowings net of Cash and cash equivalents, Other investments and Derivative financial instruments) has decreased from a net debt position of $22,923m at the beginning of the year to a net debt position of $22,510m at 31 December 2023.
Liquidity risk
The Board reviews the Group’s ongoing liquidity risks annually as part of the planning process and on an ad hoc basis. The Board considers short-term requirements against available sources of funding, taking into account forecast cash flows. The Group manages liquidity risk by maintaining access to a number of sources of funding which are sufficient to meet anticipated funding requirements. Specifically, the Group uses US and European commercial paper, bank loans, committed bank facilities and cash resources to manage short-term liquidity and manages long-term liquidity by raising funds through the capital markets. At 31 December 2023, the Group was assigned short-term credit ratings of P-1 by Moody’s and A-1 by Standard and Poor’s. The Group’s long-term credit rating was A2 Stable outlook by Moody’s and A Stable outlook by Standard and Poor’s.
In addition to Cash and cash equivalents of $5,840m, short-term fixed income investments of $20m, less overdrafts of $203m at 31 December 2023, the Group has committed bank facilities of $6,875m available to manage liquidity. These committed bank facilities have no financial covenants. $2,000m mature in February 2025. The maturity of the $4,875m facilities was extended in February 2024 from April 2026 to April 2029. The Group regularly monitors the credit standing of the banks providing the facilities and currently does not anticipate any issue with drawing on the committed facilities should this be necessary. Advances under these facilities currently bear an interest rate per annum based on SOFR (Secured Overnight Financing Rate) plus a margin.
F-46
At 31 December 2023, the Group has $4,855m outstanding from debt issued under a Euro Medium Term Note programme and $19,959m under a SEC-registered programme. The funds made available under these facility agreements may be used for the general corporate purposes of the Group.
The maturity profile of the anticipated future contractual cash flows including interest in relation to the Group’s financial liabilities, on an undiscounted basis and which, therefore, differs from both the carrying value and fair value, is as follows:
|
|
Bank |
|
|
|
|
|
|
|
Total |
|
Derivative |
|
Derivative |
|
Total |
|
|
|
|
|
overdrafts |
|
|
|
|
|
Trade |
|
non-derivative |
|
financial |
|
financial |
|
derivative |
|
|
|
|
|
and other |
|
Bonds and |
|
Lease |
|
and other |
|
financial |
|
instruments |
|
instruments |
|
financial |
|
|
|
|
|
loans |
|
bank loans |
|
liability |
|
payables |
|
instruments |
|
receivable |
|
payable |
|
instruments |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Within one year |
|
387 |
|
1,981 |
|
256 |
|
19,007 |
|
21,631 |
|
(11,766) |
|
11,774 |
|
8 |
|
21,639 |
|
In one to two years |
|
– |
|
5,647 |
|
210 |
|
2,521 |
|
8,378 |
|
(55) |
|
66 |
|
11 |
|
8,389 |
|
In two to three years |
|
– |
|
5,242 |
|
163 |
|
1,669 |
|
7,074 |
|
(1,060) |
|
1,079 |
|
19 |
|
7,093 |
|
In three to four years |
|
– |
|
2,591 |
|
130 |
|
862 |
|
3,583 |
|
(35) |
|
39 |
|
4 |
|
3,587 |
|
In four to five years |
|
– |
|
2,970 |
|
96 |
|
233 |
|
3,299 |
|
(118) |
|
111 |
|
(7) |
|
3,292 |
|
In more than five years |
|
– |
|
19,727 |
|
221 |
|
2,212 |
|
22,160 |
|
(1,521) |
|
1,480 |
|
(41) |
|
22,119 |
|
|
|
387 |
|
38,158 |
|
1,076 |
|
26,504 |
|
66,125 |
|
(14,555) |
|
14,549 |
|
(6) |
|
66,119 |
|
Effect of interest |
|
– |
|
(8,609) |
|
– |
|
– |
|
(8,609) |
|
299 |
|
(325) |
|
(26) |
|
(8,635) |
|
Effect of discounting, fair values and issue costs |
|
– |
|
(142) |
|
(89) |
|
(2,633) |
|
(2,864) |
|
(36) |
|
7 |
|
(29) |
|
(2,893) |
|
31 December 2021 |
|
387 |
|
29,407 |
|
987 |
|
23,871 |
|
54,652 |
|
(14,292) |
|
14,231 |
|
(61) |
|
54,591 |
|
|
|
Bank |
|
|
|
|
|
|
|
Total |
|
Derivative |
|
Derivative |
|
Total |
|
|
|
|
|
overdrafts |
|
|
|
|
|
Trade |
|
non-derivative |
|
financial |
|
financial |
|
derivative |
|
|
|
|
|
and other |
|
Bonds and |
|
Lease |
|
and other |
|
financial |
|
instruments |
|
instruments |
|
financial |
|
|
|
|
|
loans |
|
bank loans |
|
liability |
|
payables |
|
instruments |
|
receivable |
|
payable |
|
instruments |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Within one year |
|
365 |
|
5,777 |
|
249 |
|
19,065 |
|
25,456 |
|
(12,445) |
|
12,478 |
|
33 |
|
25,489 |
|
In one to two years |
|
– |
|
5,233 |
|
208 |
|
2,086 |
|
7,527 |
|
(1,012) |
|
1,078 |
|
66 |
|
7,593 |
|
In two to three years |
|
– |
|
2,608 |
|
172 |
|
872 |
|
3,652 |
|
(34) |
|
38 |
|
4 |
|
3,656 |
|
In three to four years |
|
– |
|
2,983 |
|
128 |
|
595 |
|
3,706 |
|
(103) |
|
103 |
|
– |
|
3,706 |
|
In four to five years |
|
– |
|
1,267 |
|
84 |
|
814 |
|
2,165 |
|
(32) |
|
35 |
|
3 |
|
2,168 |
|
In more than five years |
|
– |
|
18,156 |
|
184 |
|
3,177 |
|
21,517 |
|
(1,436) |
|
1,378 |
|
(58) |
|
21,459 |
|
|
|
365 |
|
36,024 |
|
1,025 |
|
26,609 |
|
64,023 |
|
(15,062) |
|
15,110 |
|
48 |
|
64,071 |
|
Effect of interest |
|
(15) |
|
(7,982) |
|
– |
|
– |
|
(7,997) |
|
227 |
|
(249) |
|
(22) |
|
(8,019) |
|
Effect of discounting, fair values and issue costs |
|
– |
|
(113) |
|
(72) |
|
(3,299) |
|
(3,484) |
|
63 |
|
7 |
|
70 |
|
(3,414) |
|
31 December 2022 |
|
350 |
|
27,929 |
|
953 |
|
23,310 |
|
52,542 |
|
(14,772) |
|
14,868 |
|
96 |
|
52,638 |
|
|
|
Bank |
|
|
|
|
|
|
|
Total |
|
Derivative |
|
Derivative |
|
Total |
|
|
|
|
|
overdrafts |
|
|
|
|
|
Trade |
|
non-derivative |
|
financial |
|
financial |
|
derivative |
|
|
|
|
|
and other |
|
Bonds and |
|
Lease |
|
and other |
|
financial |
|
instruments |
|
instruments |
|
financial |
|
|
|
|
|
loans |
|
bank loans |
|
liability |
|
payables |
|
instruments |
|
receivable |
|
payable |
|
instruments |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Within one year |
|
542 |
|
5,469 |
|
313 |
|
22,401 |
|
28,725 |
|
(11,302) |
|
11,366 |
|
64 |
|
28,789 |
|
In one to two years |
|
– |
|
2,764 |
|
261 |
|
1,482 |
|
4,507 |
|
(100) |
|
114 |
|
14 |
|
4,521 |
|
In two to three years |
|
– |
|
3,137 |
|
208 |
|
788 |
|
4,133 |
|
(164) |
|
179 |
|
15 |
|
4,148 |
|
In three to four years |
|
– |
|
2,230 |
|
138 |
|
625 |
|
2,993 |
|
(924) |
|
883 |
|
(41) |
|
2,952 |
|
In four to five years |
|
– |
|
3,822 |
|
88 |
|
12 |
|
3,922 |
|
(949) |
|
971 |
|
22 |
|
3,944 |
|
In more than five years |
|
– |
|
17,995 |
|
271 |
|
35 |
|
18,301 |
|
(1,507) |
|
1,340 |
|
(167) |
|
18,134 |
|
|
|
542 |
|
35,417 |
|
1,279 |
|
25,343 |
|
62,581 |
|
(14,946) |
|
14,853 |
|
(93) |
|
62,488 |
|
Effect of interest |
|
(27) |
|
(8,270) |
|
– |
|
– |
|
(8,297) |
|
589 |
|
(644) |
|
(55) |
|
(8,352) |
|
Effect of discounting, fair values and issue costs |
|
– |
|
(168) |
|
(151) |
|
(309) |
|
(628) |
|
44 |
|
(46) |
|
(2) |
|
(630) |
|
31 December 2023 |
|
515 |
|
26,979 |
|
1,128 |
|
25,034 |
|
53,656 |
|
(14,313) |
|
14,163 |
|
(150) |
|
53,506 |
|
Where interest payments are on a floating rate basis, it is assumed that rates will remain unchanged from the last business day of each year ended 31 December.
The Group has $2bn of bank loans that mature in July 2024 which the Group can repay before maturity at face value. Other than that, it is not expected that the cash flows in the maturity profile could occur significantly earlier or at significantly different amounts, with the exception of $2,137m of contingent consideration held within Trade and other payables (see Note 20).
Market risk
Interest rate risk
The Group maintains a Board-approved mix of fixed and floating rate debt and uses underlying debt, interest rate swaps and forward rate agreements to manage this mix.
The majority of surplus cash is currently invested in US dollar liquidity funds and investment-grade fixed income securities.
F-47
The interest rate profile of the Group’s interest-bearing financial instruments are set out below. In the case of current and non-current financial liabilities, the classification includes the impact of interest rate swaps which convert the debt to floating rate.
|
|
|
|
|
|
2023 |
|
|
|
|
|
2022 |
|
|
|
|
|
2021 |
|
|
|
Fixed rate |
|
Floating rate |
|
Total |
|
Fixed rate |
|
Floating rate |
|
Total |
|
Fixed rate |
|
Floating rate |
|
Total |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Financial liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current |
|
2,885 |
|
2,515 |
|
5,400 |
|
2,476 |
|
3,066 |
|
5,542 |
|
1,232 |
|
661 |
|
1,893 |
|
Non-current |
|
23,222 |
|
– |
|
23,222 |
|
21,511 |
|
2,179 |
|
23,690 |
|
23,985 |
|
4,903 |
|
28,888 |
|
Total |
|
26,107 |
|
2,515 |
|
28,622 |
|
23,987 |
|
5,245 |
|
29,232 |
|
25,217 |
|
5,564 |
|
30,781 |
|
Financial assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed deposits |
|
– |
|
– |
|
– |
|
64 |
|
– |
|
64 |
|
53 |
|
– |
|
53 |
|
Cash collateral pledged to counterparties |
|
– |
|
102 |
|
102 |
|
– |
|
162 |
|
162 |
|
– |
|
– |
|
– |
|
Cash and cash equivalents |
|
– |
|
5,840 |
|
5,840 |
|
250 |
|
5,916 |
|
6,166 |
|
– |
|
6,329 |
|
6,329 |
|
Total |
|
– |
|
5,942 |
|
5,942 |
|
314 |
|
6,078 |
|
6,392 |
|
53 |
|
6,329 |
|
6,382 |
|
In addition to the financial assets above, there are $11,288m (2022: $9,546m; 2021: $8,765m) of other current and non-current asset investments and other financial assets.
The Group is also exposed to market risk on other investments.
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Equity securities at fair value through Other comprehensive income (Note 12) |
|
1,530 |
|
1,056 |
|
1,168 |
|
Non-current fixed income securities at fair value through profit or loss (Note 12) |
|
– |
|
10 |
|
– |
|
Total |
|
1,530 |
|
1,066 |
|
1,168 |
|
Foreign currency risk
The US dollar is the Group’s most significant currency. As a consequence, the Group results are presented in US dollars and exposures are managed against US dollars accordingly.
Translational
Approximately 60% of Group external sales in 2023 were denominated in currencies other than the US dollar, while a significant proportion of manufacturing, and research and development costs were denominated in pound sterling and Swedish krona. Surplus cash generated by business units is substantially converted to, and held centrally in, US dollars. As a result, operating profit and total cash flow in US dollars will be affected by movements in exchange rates.
This currency exposure is managed centrally, based on forecast cash flows. The impact of movements in exchange rates is mitigated significantly by the correlations which exist between the major currencies to which the Group is exposed and the US dollar. Monitoring of currency exposures and correlations is undertaken on a regular basis and hedging is subject to pre-execution approval.
As at 31 December 2023, before the impact of derivatives, 2% of interest-bearing loans and borrowings were denominated in pound sterling and 16% were denominated in euros. Where there is non-US dollar debt and an underlying net investment of that amount in the same currency, the Group applies net investment hedging. Exchange differences on the retranslation of debt designated as net investment hedges are recognised in Other comprehensive income to the extent that the hedge is effective. Any ineffectiveness is taken to profit. For details of non-US dollar debt in a designated hedging relationship please see the Hedge accounting section within this Note 28 from page 200.
The Group holds cross-currency swaps to hedge against the impact of fluctuations in foreign exchange rates. Fair value movements on the revaluation of the cross-currency swaps are recognised in Other comprehensive income to the extent that the hedge is effective, with any ineffectiveness taken to profit.
As at 31 December 2023, the Group operates in three countries designated as hyperinflationary, being Argentina, Venezuela and Turkey. The foreign exchange risk of these markets has been assessed and deemed to be immaterial.
Transactional
The Group aims to hedge all its forecasted major transactional currency exposures on working capital balances, which typically extend for up to three months. Where practicable, these are hedged using forward foreign exchange contracts. In addition, external dividend payments in pound sterling to UK shareholders and in Swedish krona to Swedish shareholders are fully hedged from announcement date to payment date. Foreign exchange gains and losses on forward contracts transacted for transactional hedging are taken to profit or to Other comprehensive income if the contract is in a designated cash flow hedge.
Sensitivity analysis
The sensitivity analysis set out below summarises the sensitivity of the market value of our financial instruments to hypothetical changes in market rates and prices. The range of variables chosen for the sensitivity analysis reflects our view of changes which are reasonably possible over a one-year period. Market values are the present value of future cash flows based on market rates and prices at the valuation date. For long-term debt, an increase in interest rates results in a decline in the fair value of debt.
The sensitivity analysis assumes an instantaneous 100 basis point change in interest rates in all currencies from their levels at 31 December 2023, with all other variables held constant. Based on the composition of our long-term debt portfolio and cash reserves as at 31 December 2023, a 1% increase in interest rates would result in an additional $25m in interest expense on the debt and an additional $58m interest income on the cash reserves. The exchange rate sensitivity analysis assumes an instantaneous 10% change in foreign currency exchange rates from their levels at 31 December 2023, with all other variables held constant. The +10% case assumes a 10% strengthening of the US dollar against all other currencies and the -10% case assumes a 10% weakening of the US dollar.
F-48
Each incremental 10% movement in foreign currency exchange rates would have approximately the same effect as the initial 10% detailed in the table below and each incremental 1% change in interest rates would have approximately the same effect as the 1% detailed in the table below.
|
|
|
|
Interest rates |
|
|
|
Exchange rates |
|
31 December 2021 |
|
+1% |
|
−1% |
|
+10% |
|
−10% |
|
Increase/(decrease) in fair value of financial instruments ($m) |
|
1,978 |
|
(2,106) |
|
82 |
|
(85) |
|
Impact on profit: gain/(loss) ($m) |
|
– |
|
– |
|
24 |
|
(9) |
|
Impact on equity: gain/(loss) ($m) |
|
– |
|
– |
|
58 |
|
(76) |
|
|
|
|
|
Interest rates |
|
|
|
Exchange rates |
|
31 December 2022 |
|
+1% |
|
−1% |
|
+10% |
|
−10% |
|
Increase/(decrease) in fair value of financial instruments ($m) |
|
1,317 |
|
(1,490) |
|
81 |
|
(89) |
|
Impact on profit: gain/(loss) ($m) |
|
– |
|
– |
|
26 |
|
(15) |
|
Impact on equity: gain/(loss) ($m) |
|
– |
|
– |
|
55 |
|
(74) |
|
|
|
|
|
Interest rates |
|
|
|
Exchange rates |
|
31 December 2023 |
|
+1% |
|
−1% |
|
+10% |
|
−10% |
|
Increase/(decrease) in fair value of financial instruments ($m) |
|
1,361 |
|
(1,534) |
|
196 |
|
(212) |
|
Impact on profit: gain/(loss) ($m) |
|
– |
|
– |
|
134 |
|
(128) |
|
Impact on equity: gain/(loss) ($m) |
|
– |
|
– |
|
62 |
|
(83) |
|
Credit risk
The Group is exposed to credit risk on financial assets, such as cash investments, derivative instruments, and Trade and other receivables. The Group was also exposed in its Net asset position to its own credit risk in respect of the 2023 debentures which are accounted for at FVPL. Under IFRS 9, the effect of the losses and gains arising from own credit risk on the fair value of bonds designated at FVPL are recorded in Other comprehensive income.
Financial counterparty credit risk
The majority of the AstraZeneca Group’s cash is centralised within the Group treasury entity and is subject to counterparty risk on the principal invested. The level of the Group’s cash investments and hence credit risk will depend on the cash flow generated by the Group and the timing of the use of that cash. The credit risk is mitigated through a policy of prioritising security and liquidity over return and, as such, cash is only invested in high credit-quality investments. Counterparty limits are set according to the assessed risk of each counterparty and exposures are monitored against these limits on a regular basis.
The Group’s principal financial counterparty credit risks at 31 December 2023 were as follows:
Current assets
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Cash at bank and in hand |
|
1,325 |
|
1,411 |
|
1,461 |
|
Money market liquidity funds |
|
4,425 |
|
4,486 |
|
4,772 |
|
Other short-term cash equivalents |
|
90 |
|
269 |
|
96 |
|
Total Cash and cash equivalents (Note 17) |
|
5,840 |
|
6,166 |
|
6,329 |
|
Fixed income securities at fair value through profit or loss (Note 12) |
|
20 |
|
13 |
|
16 |
|
Cash collateral pledged to counterparties (Note 12) |
|
102 |
|
162 |
|
– |
|
Fixed deposits (Note 12) |
|
– |
|
64 |
|
53 |
|
Total derivative financial instruments (Note 13) |
|
116 |
|
87 |
|
83 |
|
Current assets subject to credit risk |
|
6,078 |
|
6,492 |
|
6,481 |
|
Non-current assets
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Derivative financial instruments (Note 13) |
|
228 |
|
74 |
|
102 |
|
Non-current assets subject to credit risk |
|
228 |
|
74 |
|
102 |
|
The majority of the Group’s cash is invested in US dollar AAA-rated money market liquidity funds. The money market liquidity fund portfolios are managed by six external third-party fund managers to maintain an AAA rating. The Group’s investments represent no more than 10% of each overall fund value. There were no other significant concentrations of financial credit risk at the reporting date.
All financial derivatives are transacted with commercial banks, in line with standard market practice. The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral, for the benefit of the other, equivalent to the market valuation of the derivative positions above a predetermined threshold. The carrying value of such cash collateral held by the Group at 31 December 2023 was $215m (2022: $89m; 2021: $93m) and the carrying value of such cash collateral posted by the Group at 31 December 2023 was $102m (2022: $162m; 2021: $47m).
The impairment provision for other financial assets at 31 December 2023 was immaterial.
Trade receivables
Trade receivable exposures are managed locally in the operating units where they arise and credit limits are set as deemed appropriate for the customer. The Group is exposed to customers ranging from government-backed agencies and large private wholesalers to privately owned pharmacies, and the underlying local economic and sovereign risks vary throughout the world. Where appropriate, the Group endeavours to minimise risks by the use of trade finance instruments such as letters of credit and insurance. The Group applies the expected credit loss approach to establish an allowance for impairment that represents its estimate of expected losses in respect of Trade receivables.
The Group applies the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime expected loss allowance to Trade receivables. To measure expected credit losses, Trade receivables have been grouped based on shared credit characteristics and the days past due.
F-49
The expected loss rates are based on payment profiles over a period of 36 months before 31 December 2023, 31 December 2022 or 31 December 2021 respectively and the corresponding historical credit losses experienced within this period. The historical loss rates are adjusted to reflect current and forward-looking information on macroeconomic factors affecting the ability of the customer to settle the receivables.
On that basis, the loss allowance was determined as follows:
|
|
|
|
0-90 days |
|
90-180 days |
|
Over 180 days |
|
|
|
31 December 2021 |
|
Current |
|
past due |
|
past due |
|
past due |
|
Total |
|
Expected loss rate |
|
0.1 |
% |
1.2 |
% |
22.6 |
% |
11.0 |
% |
|
|
Gross carrying amount ($m) |
|
5,617 |
|
328 |
|
18 |
|
91 |
|
6,054 |
|
Loss allowance ($m) |
|
5 |
|
4 |
|
4 |
|
10 |
|
23 |
|
|
|
|
|
0-90 days |
|
90-180 days |
|
Over 180 days |
|
|
|
31 December 2022 |
|
Current |
|
past due |
|
past due |
|
past due |
|
Total |
|
Expected loss rate |
|
0.03 |
% |
0.3 |
% |
32.0 |
% |
40.6 |
% |
|
|
Gross carrying amount ($m) |
|
6,791 |
|
331 |
|
50 |
|
99 |
|
7,271 |
|
Loss allowance ($m) |
|
2 |
|
1 |
|
16 |
|
40 |
|
59 |
|
|
|
|
|
0-90 days |
|
90-180 days |
|
Over 180 days |
|
|
|
31 December 2023 |
|
Current |
|
past due |
|
past due |
|
past due |
|
Total |
|
Expected loss rate |
|
0.01 |
% |
0.3 |
% |
0.8 |
% |
15.0 |
% |
|
|
Gross carrying amount ($m) |
|
7,709 |
|
342 |
|
121 |
|
280 |
|
8,452 |
|
Loss allowance ($m) |
|
1 |
|
1 |
|
1 |
|
42 |
|
45 |
|
Trade receivables are written off where there is no reasonable expectation of recovery.
Impairment losses on Trade receivables are presented as net impairment losses within Operating profit, any subsequent recoveries are credited against the same line.
In the US, sales to three wholesalers accounted for approximately 80% of US sales (2022: three wholesalers accounted for approximately 73%; 2021: three wholesalers accounted for approximately 94%).
The movements of the Group expected credit losses provision are follows:
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
At 1 January |
|
59 |
|
23 |
|
23 |
|
Net movement recognised in income statement |
|
(14) |
|
37 |
|
(2) |
|
Amounts utilised, exchange and other movements |
|
– |
|
(1) |
|
2 |
|
At 31 December |
|
45 |
|
59 |
|
23 |
|
Given the profile of our customers, including large wholesalers and government-backed agencies, no further credit risk has been identified with the Trade receivables not past due other than those balances for which an allowance has been made. The income statement credit or charge is recorded in Operating profit.
Hedge accounting
The Group uses foreign currency borrowings, foreign currency forwards and swaps, currency options, interest rate swaps and cross-currency interest rate swaps for the purpose of hedging its foreign currency and interest rate risks. The Group may designate certain financial instruments as fair value hedges, cash flow hedges or net investment hedges in accordance with IFRS 9. Hedge effectiveness is determined at the inception of the hedge relationship, and through periodic prospective effectiveness assessments to ensure that an economic relationship exists between the hedged item and hedging instrument. Sources of hedge effectiveness will depend on the hedge relationship designation but may include:
| > | a significant change in the credit risk of either party to the hedging relationship |
| > | a timing mismatch between the hedging instrument and the hedged item |
| > | movements in foreign currency basis spread for derivatives in a fair value hedge |
| > | a significant change in the value of the foreign currency-denominated net assets of the Group in a net investment hedge. |
The hedge ratio for each designation will be established by comparing the quantity of the hedging instrument and the quantity of the hedged item to determine their relative weighting; for all of the Group’s existing hedge relationships the hedge ratio has been determined as 1:1. Designated hedges are expected to be effective and therefore the impact of ineffectiveness on profit is not expected to be material. The accounting treatment for fair value hedges and debt designated as FVPL is disclosed in the Group Accounting Policies section from page 152.
F-50
The following table represents the Group’s continuing designated hedge relationships under IFRS 9.
2021
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
Fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opening |
|
Fair value |
|
recycled |
|
Closing |
|
|
|
|
|
|
|
|
|
Nominal |
|
|
|
balance |
|
(gain)/loss |
|
to the |
|
balance |
|
|
|
|
|
Average |
|
|
|
amounts |
|
Carrying |
|
1 January |
|
deferred |
|
Income |
|
31 December |
|
Average |
|
Average |
|
pay |
|
|
|
in local |
|
value |
|
2021 |
|
to OCI |
|
statement |
|
2021 |
|
maturity |
|
USD FX |
|
interest |
|
|
|
currency |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
year |
|
rate |
|
rate |
|
Cash flow hedges – foreign currency and interest rate risk1, 3, 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cross currency interest rate swaps – Euro bonds |
|
EUR 1,700m |
|
(43) |
|
46 |
|
182 |
|
(201) |
|
27 |
|
2026 |
|
1.14 |
|
USD 2.85% |
|
FX Forwards − short-term FX risk |
|
USD 1,220m |
|
12 |
|
(5) |
|
– |
|
(7) |
|
(12) |
|
2022 |
|
– |
|
– |
|
Net investment hedge – foreign exchange risk2, 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions matured pre-2021 |
|
|
|
– |
|
(565) |
|
– |
|
– |
|
(565) |
|
– |
|
– |
|
– |
|
Cross currency interest rate swap – JPY investment |
|
JPY 58.3bn |
|
62 |
|
(19) |
|
(43) |
|
– |
|
(62) |
|
2029 |
|
108.03 |
|
JPY 1.53% |
|
Cross currency interest rate swap – CNY investment |
|
CNY 458m |
|
(2) |
|
2 |
|
– |
|
– |
|
2 |
|
2026 |
|
6.68 |
|
CNY 4.80% |
|
Foreign currency borrowing – GBP investment |
|
GBP 350m |
|
470 |
|
(233) |
|
(5) |
|
– |
|
(238) |
|
2031 |
|
n/a |
|
GBP 5.75% |
|
Foreign currency borrowing – EUR investment5 |
|
EUR 450m |
|
– |
|
85 |
|
(47) |
|
– |
|
38 |
|
2021 |
|
n/a |
|
EUR 0.88% |
|
Foreign currency borrowing – EUR investment6 |
|
EUR 800m |
|
898 |
|
– |
|
(50) |
|
– |
|
(50) |
|
2029 |
|
n/a |
|
EUR 0.38% |
|
Contingent consideration liabilities and Acerta Pharma share purchase liability – AZUK and AZAB USD investments |
|
USD 2,658m |
|
(2,658) |
|
1,411 |
|
421 |
|
– |
|
1,832 |
|
– |
|
– |
|
– |
|
2022
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
Fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(gain)/loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opening |
|
Fair value |
|
recycled |
|
Closing |
|
|
|
|
|
|
|
|
|
Nominal |
|
|
|
balance |
|
(gain)/loss |
|
to the |
|
balance |
|
|
|
|
|
Average |
|
|
|
amounts |
|
Carrying |
|
1 January |
|
deferred |
|
Income |
|
31 December |
|
Average |
|
Average |
|
pay |
|
|
|
in local |
|
value |
|
2022 |
|
to OCI |
|
statement |
|
2022 |
|
maturity |
|
USD FX |
|
interest |
|
|
|
currency |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
year |
|
rate |
|
rate |
|
Cash flow hedges – foreign currency and interest rate risk1, 3, 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cross currency interest rate swaps – Euro bonds |
|
EUR 1,700m |
|
(160) |
|
27 |
|
118 |
|
(111) |
|
34 |
|
2026 |
|
1.14 |
|
USD 2.85% |
|
FX Forwards − short-term FX risk |
|
USD 1,126m |
|
(12) |
|
(12) |
|
(14) |
|
38 |
|
12 |
|
2023 |
|
– |
|
– |
|
Net investment hedge – foreign exchange risk2, 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions matured pre-2022 |
|
|
|
– |
|
(527) |
|
– |
|
– |
|
(527) |
|
– |
|
– |
|
– |
|
Cross currency interest rate swap – JPY investment |
|
JPY 58.3bn |
|
55 |
|
(62) |
|
7 |
|
– |
|
(55) |
|
2029 |
|
108.03 |
|
JPY 1.53% |
|
Cross currency interest rate swap – CNY investment |
|
CNY 458m |
|
(4) |
|
2 |
|
2 |
|
– |
|
4 |
|
2026 |
|
6.68 |
|
CNY 4.80% |
|
Foreign currency borrowing – GBP investment |
|
GBP 350m |
|
420 |
|
(238) |
|
(50) |
|
– |
|
(288) |
|
2031 |
|
n/a |
|
GBP 5.75% |
|
Foreign currency borrowing – EUR investment6 |
|
EUR 800m |
|
846 |
|
(50) |
|
(52) |
|
– |
|
(102) |
|
2029 |
|
n/a |
|
EUR 0.38% |
|
Contingent consideration liabilities and Acerta Pharma share purchase liability – AZUK and AZAB USD investments |
|
USD 2,093m |
|
(2,093) |
|
1,832 |
|
384 |
|
– |
|
2,216 |
|
– |
|
– |
|
– |
|
2023
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
Fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(gain)/loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opening |
|
Fair value |
|
recycled |
|
Closing |
|
|
|
|
|
|
|
|
|
Nominal |
|
|
|
balance |
|
(gain)/loss |
|
to the |
|
balance |
|
|
|
|
|
Average |
|
|
|
amounts |
|
Carrying |
|
1 January |
|
deferred |
|
Income |
|
31 December |
|
Average |
|
Average |
|
pay |
|
|
|
in local |
|
value |
|
2023 |
|
to OCI |
|
statement |
|
2023 |
|
maturity |
|
USD FX |
|
interest |
|
|
|
currency |
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
year |
|
rate |
|
rate |
|
Cash flow hedges – foreign currency and interest rate risk2, 4, 5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cross currency interest rate swaps – Euro bonds |
|
EUR 3,200m |
|
49 |
|
34 |
|
(210) |
|
139 |
|
(37) |
|
2027 |
|
1.10 |
|
USD 3.80% |
|
FX Forwards − short-term FX risk |
|
USD 2,009m |
|
15 |
|
12 |
|
(33) |
|
6 |
|
(15) |
|
2024 |
|
– |
|
– |
|
Net investment hedge – foreign exchange risk3, 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transactions matured pre-2023 |
|
|
|
– |
|
(527) |
|
– |
|
– |
|
(527) |
|
– |
|
– |
|
– |
|
Cross currency interest rate swap – JPY investment |
|
JPY 58.3bn |
|
100 |
|
(55) |
|
(45) |
|
– |
|
(100) |
|
2029 |
|
108.03 |
|
JPY 1.53% |
|
Cross currency interest rate swap – CNY investment |
|
CNY 458m |
|
(1) |
|
4 |
|
(3) |
|
– |
|
1 |
|
2026 |
|
6.68 |
|
CNY 4.80% |
|
Foreign currency borrowing – GBP investment |
|
GBP 350m |
|
444 |
|
(288) |
|
24 |
|
– |
|
(264) |
|
2031 |
|
n/a |
|
GBP 5.75% |
|
Foreign currency borrowing – EUR investment7 |
|
EUR 800m |
|
881 |
|
(102) |
|
33 |
|
– |
|
(69) |
|
2029 |
|
n/a |
|
EUR 0.38% |
|
Contingent consideration liabilities and Acerta Pharma share purchase liability – AZUK and AZAB USD investments |
|
USD 1,937m |
|
(1,937) |
|
2,216 |
|
(81) |
|
– |
|
2,135 |
|
– |
|
– |
|
– |
|
| 1 | Swaps designated in a fair value hedge matured on 24 November 2021 and hedge ineffectiveness during 2023 was $nil (2022: $nil; 2021: $nil). |
| 2 | Hedge ineffectiveness recognised on swaps designated in a cash flow hedge during the period was $nil (2022: $nil; 2021: $nil). |
| 3 | Hedge ineffectiveness recognised on swaps designated in a net investment hedge during the period was $nil (2022: $nil; 2021: $nil). |
| 4 | Fair value movements on cross-currency interest rate swaps in cash flow hedge and net investment hedge relationships are shown inclusive of the impact of costs of hedging. |
| 5 | Nominal amount of FX forwards in a cash flow hedge of $2,009m represents the USD equivalent notional of the FX forwards. By currency, the nominal amounts were SEK 9,778m at FX rate 9.9869, JPY 24,351m at 141.4050, GBP 428m at 0.7844 and EUR 228m at 0.9036. All FX forwards in a cash flow hedge mature on 25 January 2024. |
| 6 | The EUR 450m NIH matured in November 2021, when the hedging instrument, a EUR bond matured. |
| 7 | On 3 June 2021, upon issuance of the EUR 800m 0.375% 2029 Non-callable bond, EUR 550m was designated in a net investment hedge of the foreign currency exposure in relation of an equivalent amount of EUR-denominated net assets. The remaining EUR 250m was subsequently designated in a net investment hedge upon maturity of the EUR 450m bond on 24 November 2021. |
Key controls applied to transactions in derivative financial instruments are to use only instruments where good market liquidity exists, to revalue all financial instruments regularly using current market rates and to sell options only to offset previously purchased options or as part of a risk management strategy. The Group is not a net seller of options, and does not use derivative financial instruments for speculative purposes. The Group held no options during the reporting period.
F-51
29 Employee costs and share plans for employees
Employee costs
The monthly average number of people, to the nearest hundred, employed by the Group is set out in the table below. In accordance with the Companies Act 2006, this includes part-time employees.
|
|
2023 |
|
2022 |
|
2021 |
|
Employees |
|
|
|
|
|
|
|
UK |
|
10,700 |
|
9,800 |
|
8,900 |
|
Rest of Europe |
|
23,000 |
|
20,600 |
|
18,300 |
|
The Americas |
|
22,400 |
|
20,900 |
|
18,800 |
|
Asia, Africa & Australasia |
|
30,300 |
|
30,700 |
|
33,600 |
|
Continuing operations |
|
86,400 |
|
82,000 |
|
79,600 |
|
Geographical distribution described in the table above is by location of legal entity employing staff. Certain staff will undertake some or all of their activity in a different location.
The number of people employed by the Group at the end of 2023 was 89,900 (2022: 83,500; 2021: 83,100).
The costs incurred during the year in respect of these employees were:
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$m |
|
$m |
|
$m |
|
Wages and salaries |
|
9,341 |
|
8,656 |
|
7,633 |
|
Social security costs |
|
1,100 |
|
991 |
|
886 |
|
Pension costs |
|
537 |
|
546 |
|
564 |
|
Other employment costs |
|
1,357 |
|
1,338 |
|
1,192 |
|
Total |
|
12,335 |
|
11,531 |
|
10,275 |
|
Severance costs of $123m are not included above (2022: $227m; 2021: $238m).
The charge for share-based payments in respect of share plans is $579m (2022: $619m; 2021: $615m). Payments made to the Employee Benefit Trust upon vesting of share awards are recognised within operating cash flows, reflecting the substance of the arrangement in place between the Group and the Trust. The plans are equity settled.
The Directors believe that, together with the basic salary system, the Group’s employee incentive schemes provide competitive and market-related packages to motivate employees. They should also align the interests of employees with those of shareholders, as a whole, through long-term share ownership in the Company. The Group’s current US, UK and Swedish schemes are described below; other arrangements apply elsewhere.
Bonus and share plans
US
In the US, there are two employee short-term performance bonus plans in operation to differentiate and reward strong individual performance. Performance bonuses are paid in cash. The AstraZeneca Performance Share Plan and the AstraZeneca Global Restricted Share Plan operate in respect of relevant employees in the US. AstraZeneca ADRs necessary to satisfy the awards are purchased on the market or funded via a trust.
UK
The AstraZeneca UK Performance Bonus Plan
Employees of participating AstraZeneca UK companies are invited to participate in this bonus plan, which rewards strong individual performance. Bonuses are paid in cash.
The AstraZeneca UK All-Employee Share Plan
The Company offers UK employees the opportunity to buy Partnership Shares (Ordinary Shares). Employees may invest up to £150 a month to purchase Partnership Shares in the Company at the current market value. In 2010, the Company introduced a Matching Share element, the first award of which was made in 2011. Currently one Matching Share is awarded for every four Partnership Shares purchased. Partnership Shares and Matching Shares are held in the HM Revenue & Customs (HMRC)-approved All-Employee Share Plan. At the Company’s AGM in 2002, shareholders approved the issue of new shares for the purposes of the All-Employee Share Plan.
Sweden
In Sweden, an all-employee performance bonus plan is in operation, which rewards strong individual performance. Bonuses are paid 50% into a fund investing in AstraZeneca equities and 50% in cash. The AstraZeneca Executive Annual Bonus Scheme, the AstraZeneca Performance Share Plan and the AstraZeneca Global Restricted Stock Plan all operate in respect of relevant AstraZeneca employees in Sweden.
Other bonus and share plans that operate across the Group are described below.
The AstraZeneca Executive Annual Bonus Scheme
This scheme is a performance bonus scheme for Directors and senior employees who do not participate in the AstraZeneca UK Performance Bonus Plan. Annual bonuses are paid in cash and reflect both corporate and individual performance measures. The Remuneration Committee has discretion to reduce or withhold bonuses if business performance falls sufficiently short of expectations in any year such as to make the payment of bonuses inappropriate.
The AstraZeneca Deferred Bonus Plan
This plan was introduced in 2006 and is used to defer a portion of the bonus earned under the AstraZeneca Executive Annual Bonus Scheme into Ordinary Shares in the Company for a period of three years. The plan currently operates only in respect of Executive Directors and members of the SET (with awards granted as AstraZeneca ADRs for members of SET employed within the US). Awards of shares under this plan are typically made in March each year, the first award having been made in February 2006.
F-52
The AstraZeneca Performance Share Plan
This plan was approved by shareholders in 2020 for a period of 10 years (subsequently amended by approval of shareholders in 2021) and replaces the 2014 AstraZeneca Performance Share Plan. Generally, awards can be granted at any time, but not during a closed period of the Company. The first grant of Performance Share Plan awards was made in May 2014 under the 2014 AstraZeneca Performance Share Plan. Awards granted under the plan vest after three years, or in the case of Executive Directors and members of the SET, after an additional two-year holding period, and is subject to the achievement of performance conditions. For awards granted to all participants in 2023, vesting is subject to a combination of measures focused on science and innovation, revenue growth, financial performance and carbon reduction. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated, including agreeing performance targets and which employees should be eligible to participate.
The AstraZeneca Investment Plan
This plan was introduced in 2010 and approved by shareholders at the 2010 AGM. The final grant of awards under this plan took place in March 2016. Awards granted under the plan vest after eight years and are subject to performance conditions measured over a period of four years.
The AstraZeneca Global Restricted Stock Plan
The Global Restricted Stock Plan (GRSP) was introduced in 2010. This plan provides for the grant of restricted stock unit (RSU) awards to selected below SET-level employees and is used in conjunction with the AstraZeneca Performance Share Plan to provide a mix of RSUs and performance share units (PSUs). Awards typically vest on the third anniversary of the date of grant and are contingent on continued employment with the Company. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated.
The AstraZeneca Restricted Share Plan
This plan was introduced in 2008 and provides for the grant of restricted share unit (RSU) awards to key employees, excluding Executive Directors. Awards are made on an ad hoc basis with variable vesting dates. The plan has been used five times in 2023 to make awards to 305 employees. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated.
The AstraZeneca Extended Incentive Plan
This plan was introduced in 2018 and provides for the grant of awards to key employees, excluding Executive Directors. Awards are made on an ad hoc basis and 50% of the award will normally vest on the fifth anniversary of grant, with the balance vesting on the tenth anniversary of grant. The award can be subject to the achievement of performance conditions. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated, including agreeing performance targets (if any) and which employees should be invited to participate.
Details of share options outstanding during the year for the main share plans are shown below.
|
|
The AstraZeneca |
|
The AstraZeneca |
|
The AstraZeneca |
|
The AstraZeneca |
|
||||||||
|
|
Ordinary Shares |
|
ADR Shares |
|
Ordinary Shares |
|
ADR Shares |
1 |
Ordinary Shares |
|
ADR Shares |
|
Ordinary Shares |
|
ADR Shares |
|
|
|
ʼ000 |
|
ʼ000 |
|
ʼ000 |
|
ʼ000 |
|
ʼ000 |
|
ʼ000 |
|
ʼ000 |
|
ʼ000 |
|
Outstanding at 1 January 2021 |
|
3,045 |
|
4,791 |
|
1,626 |
|
9,175 |
|
161 |
|
506 |
|
300 |
|
65 |
|
Granted |
|
1,275 |
|
2,082 |
|
902 |
|
4,509 |
|
139 |
|
481 |
|
– |
|
175 |
|
Forfeited |
|
(220) |
|
(494) |
|
(158) |
|
(1,254) |
|
(18) |
|
(42) |
|
(18) |
|
(45) |
|
Cancelled |
|
(9) |
|
– |
|
(1) |
|
(8) |
|
– |
|
– |
|
– |
|
– |
|
Exercised |
|
(632) |
|
(1,201) |
|
(341) |
|
(2,881) |
|
(27) |
|
(182) |
|
– |
|
– |
|
Outstanding at 31 December 2021 |
|
3,459 |
|
5,178 |
|
2,028 |
|
9,541 |
|
255 |
|
763 |
|
282 |
|
195 |
|
Granted |
|
1,059 |
|
2,339 |
|
1,237 |
|
6,478 |
|
75 |
|
216 |
|
– |
|
– |
|
Forfeited |
|
(132) |
|
(570) |
|
(190) |
|
(1,627) |
|
(25) |
|
(136) |
|
(23) |
|
– |
|
Cancelled |
|
– |
|
– |
|
– |
|
(3) |
|
– |
|
– |
|
– |
|
– |
|
Exercised |
|
(756) |
|
(1,223) |
|
(606) |
|
(2,706) |
|
(72) |
|
(165) |
|
– |
|
– |
|
Outstanding at 31 December 2022 |
|
3,630 |
|
5,724 |
|
2,469 |
|
11,683 |
|
233 |
|
678 |
|
259 |
|
195 |
|
Granted |
|
976 |
|
2,071 |
|
1,185 |
|
6,343 |
|
208 |
|
436 |
|
71 |
|
95 |
|
Forfeited |
|
(148) |
|
(437) |
|
(187) |
|
(1,417) |
|
(20) |
|
(59) |
|
(8) |
|
– |
|
Cancelled |
|
– |
|
– |
|
– |
|
(3) |
|
– |
|
– |
|
– |
|
(34) |
|
Exercised |
|
(813) |
|
(1,470) |
|
(570) |
|
(2,738) |
|
(86) |
|
(288) |
|
(107) |
|
(9) |
|
Outstanding at 31 December 2023 |
|
3,645 |
|
5,888 |
|
2,897 |
|
13,868 |
|
335 |
|
767 |
|
215 |
|
247 |
|
| 1 | Shares issued to Alexion employees under the GRSP are covered under the Alexion employee share award below. |
|
|
The AstraZeneca |
|
The AstraZeneca |
|
The AstraZeneca |
|
The AstraZeneca |
|
||||||||
|
|
WAFV |
1 |
WAFV |
|
WAFV |
|
WAFV |
|
WAFV |
|
WAFV |
|
WAFV |
|
WAFV |
|
|
|
pence |
|
$ |
|
pence |
|
$ |
|
pence |
|
$ |
|
pence |
|
$ |
|
WAFV of 2021 grants |
|
6012 |
|
41.56 |
|
6893 |
|
47.75 |
|
7415 |
|
53.96 |
|
– |
|
56.83 |
|
WAFV of 2022 grants |
|
8328 |
|
55.73 |
|
9167 |
|
61.21 |
|
9894 |
|
63.35 |
|
– |
|
– |
|
WAFV of 2023 grants |
|
9929 |
|
59.95 |
|
10822 |
|
65.38 |
|
11135 |
|
65.37 |
|
11748 |
|
74.78 |
|
| 1 | Weighted average fair value. |
Alexion employee share award plan
At acquisition in 2021 Alexion employee share awards were converted into AstraZeneca restricted stock awards that continue to have, and shall be subject to, the same terms and conditions as applied in the corresponding Alexion awards immediately prior to completion. The fair value at the grant date was $57.54 and of the 15,220,000 shares outstanding at 31 December 2021, 8,627,000 were exercised and 980,000 were forfeited during 2022. During 2022, Alexion employees had the option to defer awards due to vest in July 2022 until February 2023 when they would also receive an additional vest equivalent to 15% of the shares deferred. As a result, 1,780,000 shares were deferred, resulting in an additional 267,000 shares being issued with a grant date fair value of $65.62, that vested in 2023. During 2023, 2,060,000 shares vested, 531,000 were forfeited/cancelled and the closing balance of these awards as of 31 December 2023 was 3,022,000.
F-53
The weighted average fair value for awards granted under the AstraZeneca Performance Share Plan is primarily based on the market price at the point of grant adjusted for the market-based performance elements which are valued using a modified version of the Monte Carlo method. The fair values of all other plans are set using the market price at the point of award. These awards are settled in equity including dividends accumulated from the date of award to vesting.
30 Commitments, contingent liabilities and contingent assets
|
|
2023 |
|
2022 |
|
2021 |
|
Commitments |
|
$m |
|
$m |
|
$m |
|
Contracts placed for future capital expenditure on Property, plant and equipment and |
|
1,368 |
|
502 |
|
388 |
|
Guarantees and contingencies arising in the ordinary course of business, for which no security has been given, are not expected to result in any material financial loss.
Research and development collaboration payments
The Group has various ongoing collaborations, including in-licensing and similar arrangements with development partners. Such collaborations may require the Group to make payments on achievement of stages of development, launch or revenue milestones, although the Group generally has the right to terminate these agreements at no cost. The Group recognises research and development milestones as an intangible asset once it is committed to payment, which is generally when the Group reaches set trigger points in the development cycle. Revenue-related milestones are recognised as intangible assets on product launch at a value based on the Group’s long-term revenue forecasts for the related product. The table below indicates potential development and revenue-related payments that the Group may be required to make under such collaborations.
|
|
|
|
|
|
|
|
|
|
Years 5 |
|
|
|
Total |
|
Under 1 year |
|
Years 1 and 2 |
|
Years 3 and 4 |
|
and greater |
|
|
|
$m |
|
$m |
|
$m |
|
$m |
|
$m |
|
Future potential research and development milestone payments |
|
10,971 |
|
1,256 |
|
3,798 |
|
1,764 |
|
4,153 |
|
Future potential revenue milestone payments |
|
20,195 |
|
43 |
|
491 |
|
2,400 |
|
17,261 |
|
The table includes all potential payments for achievement of milestones under ongoing research and development arrangements. Revenue-related milestone payments represent the maximum possible amount payable on achievement of specified levels of revenue as set out in individual contract agreements, but exclude variable payments that are based on unit sales (e.g. royalty-type payments) which are expensed as the associated sale is recognised. The table excludes any payments already capitalised in the Financial Statements for the year ended 31 December 2023 which have been capitalised with reference to the latest Group sales forecasts for approved indications.
The future payments we disclose represent contracted payments and, as such, are not discounted and are not risk-adjusted. As detailed in the Risk section from page 54, the development of any pharmaceutical product candidate is a complex and risky process that may fail at any stage in the development process due to a number of factors (including items such as failure to obtain regulatory approval, unfavourable data from key studies, adverse reactions to the product candidate or indications of other safety concerns). The timing of the payments is based on the Group’s current best estimate of achievement of the relevant milestone.
Environmental costs and liabilities
The Group’s expenditure on environmental protection, including both capital and revenue items, relates to costs that are necessary for implementing internal systems and programmes, and meeting legal and regulatory requirements for processes and products. This includes investment to conserve natural resources and otherwise minimise the impact of our activities on the environment.
They are an integral part of normal ongoing expenditure for carrying out the Group’s research, manufacturing and commercial operations and are not separated from overall operating and development costs. There are no known changes in legal, regulatory or other requirements resulting in material changes to the levels of expenditure for 2021, 2022 or 2023.
In addition to expenditure for meeting current and foreseen environmental protection requirements, the Group incurs costs in investigating and cleaning up legacy land and groundwater contamination. In particular, AstraZeneca has environmental liabilities at some currently or formerly owned, leased and third-party sites.
In the US, Zeneca Inc., and/or its indemnitees, have been named as potentially responsible parties (PRPs) or defendants at a number of sites where Zeneca Inc. is likely to incur future environmental investigation, remediation, operation and maintenance costs under federal, state, statutory or common law environmental liability allocation schemes (together, US Environmental Consequences). Similarly, Stauffer Management Company LLC (SMC), which was established in 1987 to own and manage certain assets of Stauffer Chemical Company acquired that year, and/or its indemnitees, have been named as PRPs or defendants at a number of sites where SMC is likely to incur US Environmental Consequences.
AstraZeneca has also given indemnities to third parties for a number of sites outside the US. These environmental liabilities arise from legacy operations that are not currently part of the Group’s business and, at most of these sites, remediation, where required, is either completed or in progress. AstraZeneca has made provisions for the estimated costs of future environmental investigation, remediation, operation and maintenance activity beyond normal ongoing expenditure for maintaining the Group’s R&D and manufacturing capacity and product ranges, where a present obligation exists, it is probable that such costs will be incurred and they can be estimated reliably. With respect to such estimated future costs, there were provisions at 31 December 2023 in the aggregate of $112m (2022: $131m; 2021: $90m), mainly relating to the US. Where we are jointly liable or otherwise have cost-sharing agreements with third parties, we reflect only our share of the obligation. Where the liability is insured in part or in whole by insurance or other arrangements for reimbursement, an asset is recognised to the extent that this recovery is virtually certain.
It is possible that AstraZeneca could incur future environmental costs beyond the extent of our current provisions. The extent of such possible additional costs is inherently difficult to estimate due to a number of factors, including: (1) the nature and extent of claims that may be asserted in the future; (2) whether AstraZeneca has or will have any legal obligation with respect to asserted or unasserted claims; (3) the type of remedial action, if any, that may be selected at sites where the remedy is presently not known; (4) the potential for recoveries from or allocation of liability to third parties; and (5) the length of time that the environmental investigation, remediation and liability allocation process can take. As per our accounting policy on page 158, Provisions for these costs are made when there is a present obligation and where it is probable that expenditure on remedial work will be required and a reliable estimate can be made of the cost. Notwithstanding and subject to the foregoing, we estimate the potential additional loss for future environmental investigation, remediation, remedial operation and maintenance activity above and beyond our provisions to be, in aggregate, between $114m and $191m (2022: $113m and $188m; 2021: $99m and $165m) which relates mainly to the US.
F-54
Legal proceedings
AstraZeneca is involved in various legal proceedings considered typical to its business, including actual or threatened litigation and actual or potential government investigations relating to employment matters, product liability, commercial disputes, pricing, sales and marketing practices, infringement of IP rights, and the validity of certain patents and competition laws. The more significant matters are discussed below.
Most of the claims involve highly complex issues. Often these issues are subject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or an estimate of the amount of any loss is difficult to ascertain.
We do not believe that disclosure of the amounts sought by plaintiffs, if known, would be meaningful with respect to these legal proceedings. This is due to a number of factors, including (i) the stage of the proceedings (in many cases trial dates have not been set) and the overall length and extent of pre-trial discovery; (ii) the entitlement of the parties to an action to appeal a decision; (iii) clarity as to theories of liability, damages and governing law; (iv) uncertainties in timing of litigation; and (v) the possible need for further legal proceedings to establish the appropriate amount of damages, if any.
While there can be no assurance regarding the outcome of any of the legal proceedings referred to in this Note 30, based on management’s current and considered view of each situation, we do not currently expect them to have a material adverse effect on our financial position including within the next financial year. This position could of course change over time, not least because of the factors referred to above.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal (or other similar forms of relief), or where a loss is probable and we are able to make a reasonable estimate of the loss, we generally indicate the loss absorbed or make a provision for our best estimate of the expected loss.
Where it is considered that the Group is more likely than not to prevail, legal costs involved in defending the claim are charged to profit as they are incurred.
Where it is considered that the Group has a valid contract which provides the right to reimbursement (from insurance or otherwise) of legal costs and/or all or part of any loss incurred or for which a provision has been established, and we consider recovery to be virtually certain, the best estimate of the amount expected to be received is recognised as an asset.
Assessments as to whether or not to recognise provisions or assets, and of the amounts concerned, usually involve a series of complex judgements about future events and can rely heavily on estimates and assumptions. AstraZeneca believes that the provisions recorded are adequate based on currently available information and that the insurance recoveries recorded will be received. However, given the inherent uncertainties involved in assessing the outcomes of these cases, and in estimating the amount of the potential losses and the associated insurance recoveries, we could in the future incur judgments or insurance settlements that could have a material adverse effect on our results in any particular period.
IP claims include challenges to the Group’s patents on various products or processes and assertions of non-infringement of patents. A loss in any of these cases could result in loss of patent protection on the related product.
The consequences of any such loss could be a significant decrease in Product Sales, which could have a material adverse effect on our results. The lawsuits filed by AstraZeneca for patent infringement against companies that have filed abbreviated new drug applications (ANDAs) in the US, seeking to market generic forms of products sold by the Group prior to the expiry of the applicable patents covering these products, typically also involve allegations of non-infringement, invalidity and unenforceability of these patents by the ANDA filers. In the event that the Group is unsuccessful in these actions or the statutory 30-month stay expires before a ruling is obtained, the ANDA filers involved will also have the ability, subject to FDA approval, to introduce generic versions of the product concerned.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP.
Over the course of the past several years, including in 2023, a significant number of commercial litigation claims in which AstraZeneca is involved have been resolved, particularly in the US, thereby reducing potential contingent liability exposure arising from such litigation. Similarly, in part due to patent litigation and settlement developments, greater certainty has been achieved regarding possible generic entry dates with respect to some of our patented products. At the same time, like other companies in the pharmaceutical sector and other industries, AstraZeneca continues to be subject to government investigations around the world.
Patent litigation
Legal proceedings brought against AstraZeneca for which a provision has been taken
Imfinzi and Imjudo
US and ROW patent proceedings
In February 2022, in Japan, Ono Pharmaceuticals filed a lawsuit in Tokyo District Court, Civil Division against AstraZeneca alleging that AstraZeneca’s marketing of Imfinzi in Japan infringed several of their patents.
In March 2022, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC filed a lawsuit in the US District Court for the District of Delaware (District Court) against AstraZeneca alleging that AstraZeneca’s marketing of Imfinzi infringed several of their patents. In April 2023, Bristol-Myers Squibb Co., E.R. Squibb & Sons, LLC, Tasuku Honjo, Ono Pharmaceutical Co., Ltd., and the Dana-Farber Cancer Institute Inc. filed a separate lawsuit in the District Court against AstraZeneca alleging that AstraZeneca’s marketing of Imfinzi infringed another of their patents.
In January 2023, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC filed a lawsuit in the District Court against AstraZeneca alleging that AstraZeneca’s marketing of Imjudo infringed two of their patents.
In July 2023, AstraZeneca entered into a global settlement agreement with Bristol-Myers Squibb Co., E.R. Squibb & Sons, LLC, and Ono Pharmaceutical Co., Ltd. that resolves all patent disputes between the companies relating to Imfinzi and Imjudo. In June 2023, a provision was taken totaling $510m.
These matters are now concluded.
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Enhertu
US patent proceedings
In October 2020, Seagen Inc. (Seagen) filed a complaint against Daiichi Sankyo Company, Limited (Daiichi Sankyo) in the US District Court for the Eastern District of Texas (District Court) alleging that Enhertu infringes a Seagen patent. AstraZeneca co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US. After trial in April 2022, the jury found that the patent was infringed and awarded Seagen $41.82m in past damages. In July 2022, the District Court entered final judgment and declined to enhance damages on the basis of wilfulness. In October 2023, the District Court entered an amended final judgment that requires Daiichi Sankyo to pay Seagen a royalty of 8% on US sales of Enhertu from April 1, 2022, through November 4, 2024, in addition to the past damages previously awarded by the Court. AstraZeneca and Daiichi Sankyo have appealed the District Court’s decision.
F-55
In December 2020 and January 2021, AstraZeneca and Daiichi Sankyo, Inc. filed post-grant review (PGR) petitions with the US Patent and Trademark Office (USPTO) alleging, inter alia, that the Seagen patent is invalid for lack of written description and enablement. The USPTO initially declined to institute the PGRs, but, in April 2022, the USPTO granted the rehearing requests, instituting both PGR petitions. Seagen subsequently disclaimed all patent claims at issue in one of the PGR proceedings. In July 2022, the USPTO reversed its institution decision and declined to institute the other PGR petition. AstraZeneca and Daiichi Sankyo, Inc. requested reconsideration of the decision not to institute review of the patent. In February 2023, the USPTO reinstituted the PGR proceeding. An oral hearing took place in August 2023. In January 2024, the USPTO issued a decision that Seagen's patent is unpatentable, invalidating all claims asserted against Enhertu. The USPTO’s decision does not overturn the Texas District Court’s decision unless and until the USPTO’s decision is affirmed on appeal by the US Court of Appeals for the Federal Circuit. No such appeal has been filed.
Faslodex
Patent proceedings outside the US
In 2021 in Japan, AstraZeneca received notice from the Japan Patent Office (JPO) that Sandoz K.K. (Sandoz) and Sun Pharma Japan Ltd. (Sun) were seeking to invalidate the Faslodex formulation patent. AstraZeneca defended the challenged patent, and Sun withdrew from the JPO patent challenge. In July 2023, the JPO issued a final decision upholding various claims of the challenged patent and determining that other patent claims were invalid. In August 2023, Sandoz appealed the JPO decision to the Japan IP High Court.
Tagrisso
US patent proceedings
In September 2021, Puma Biotechnology, Inc. and Wyeth LLC filed a patent infringement lawsuit in the US District Court for the District of Delaware against AstraZeneca relating to Tagrisso. Trial has been scheduled for May 2024.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Brilinta
US patent proceedings
In 2015 and subsequently, in response to Paragraph IV notices from ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of Delaware (District Court) relating to patents listed in the FDA Orange Book with reference to Brilinta. In 2022, AstraZeneca entered into several separate settlements and the District Court entered consent judgments to dismiss each of the corresponding litigations. Additional proceedings are ongoing in the District Court. No trial date has been set.
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of Delaware. In its complaint, AstraZeneca alleges that a generic version of Calquence, if approved and marketed, would infringe patents listed in the FDA Orange Book with reference to Calquence that are owned or licensed by AstraZeneca. Trial has been scheduled for March 2025.
In February 2023, Sandoz Inc. filed a petition for inter partes review with the US Patent and Trademark Office of certain Calquence patent claims. AstraZeneca has asserted claims for patent infringement against Sandoz and other defendants in the US ANDA litigation. In August 2023, the US Patent Trial and Appeal Board issued a decision denying institution of inter partes review.
Daliresp
US patent proceedings
In 2015 and subsequently, in response to Paragraph IV notices from ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of New Jersey (District Court) relating to patents listed in the FDA Orange Book with reference to Daliresp. In 2022, AstraZeneca entered into a settlement agreement and the District Court entered a consent judgment to dismiss the corresponding litigation. Additional ANDA challenges are pending.
Farxiga
US patent proceedings
In May 2021, AstraZeneca proceeded to trial against ANDA filer Zydus Pharmaceuticals (USA) Inc. (Zydus) in the US District Court for the District of Delaware (District Court). In October 2021, the District Court issued a decision finding the asserted claims of AstraZeneca’s patent as valid and infringed by Zydus’s ANDA product. In August 2022, Zydus appealed the District Court decision. Zydus’s appeal has been dismissed.
In December 2023, AstraZeneca initiated ANDA litigation against Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. in the District Court. No trial date has been set.
Lokelma
US patent proceedings
In August 2022, in response to Paragraph IV notices, AstraZeneca initiated ANDA litigation against multiple generic filers in the US District Court for the District of Delaware. Trial has been scheduled for March 2025.
Lynparza
US patent proceedings
In December 2022, AstraZeneca received a Paragraph IV notice from an ANDA filer relating to patents listed in the FDA Orange Book with reference to Lynparza. In February 2023, in response to the Paragraph IV notice, AstraZeneca, MSD International Business GmbH, and the University of Sheffield initiated ANDA litigation against Natco Pharma Limited (Natco) in the US District Court for the District of New Jersey. In the complaint, AstraZeneca alleged that Natco’s generic version of Lynparza, if approved and marketed, would infringe patents listed in the FDA Orange Book with reference to Lynparza. No trial date has been scheduled.
In December 2023, AstraZeneca received a Paragraph IV notice from an ANDA filer relating to patents listed in the FDA Orange Book with reference to Lynparza. In February 2024, in response to the Paragraph IV notice, AstraZeneca, MSD International Business GmbH, and the University of Sheffield initiated ANDA litigation against Sandoz Inc. (Sandoz) in the US District Court for the District of New Jersey. In the complaint, AstraZeneca alleged that Sandoz’s generic version of Lynparza, if approved and marketed, would infringe patents listed in the FDA Orange Book with reference to Lynparza. No trial date has been scheduled.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent infringement litigation against Samsung Bioepis Co. Ltd. in the US District Court for the District of Delaware alleging that Samsung’s biosimilar eculizumab product, for which Samsung is currently seeking FDA approval, will infringe six Soliris-related patents. No trial date has been scheduled. Five of the six asserted patents are also the subject of inter partes review proceedings before the US Patent and Trademark Office.
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Tagrisso
Patent proceedings outside the US
In Russia, in August 2023, AstraZeneca filed lawsuits in the Arbitration Court of the Moscow Region (Court) against the Ministry of Health of the Russian Federation and Axelpharm LLC related to Axelpharm’s improper use of AstraZeneca’s information to obtain authorisation to market a generic version of Tagrisso. In December 2023, the Court dismissed the lawsuit against the Ministry of Health of the Russian Federation. In January 2024, AstraZeneca filed an appeal, which is pending. The lawsuit against Axelpharm remains pending before the Court.
In Russia, in November 2023, Axelpharm LLC filed a compulsory licensing action against AstraZeneca in the Arbitration Court of the Moscow Region (Court) related to a patent that covers Tagrisso. The lawsuit remains pending before the Court.
Legal proceedings brought against AstraZeneca which have been concluded
Movantik
US patent proceedings
AstraZeneca has resolved by settlement agreement the previously disclosed patent infringement lawsuit brought by Aether Therapeutics, Inc. in the US District Court for the District of Delaware against AstraZeneca, Nektar Therapeutics and Daiichi Sankyo, Inc., relating to Movantik. This matter is now concluded.
Legal proceedings brought by AstraZeneca which have been concluded
Symbicort
US patent proceedings
In February 2023, AstraZeneca resolved by settlement agreement the previously disclosed ANDA litigations with Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P. (together, defendants). In those actions, AstraZeneca alleged that the defendants' generic versions of Symbicort, if approved and marketed, would infringe various AstraZeneca patents. This matter is now concluded.
Tagrisso
Patent proceedings outside the US
In Russia, in October 2021, AstraZeneca filed a lawsuit in the Arbitration Court of the Moscow Region (Court) against Axelpharm, LLC to prevent it from obtaining authorisation to market a generic version of Tagrisso prior to the expiration of AstraZeneca’s patents covering Tagrisso. The lawsuit also names the Ministry of Health of the Russian Federation as a third party. In March 2022, the Court dismissed the lawsuit. In June 2022, the dismissal was affirmed on appeal. In January 2023, the dismissal was affirmed on further appeal. This matter is now concluded.
Product liability litigation
Legal proceedings brought against AstraZeneca for which a provision has been taken
Nexium and Losec/Prilosec
US proceedings
AstraZeneca has been defending lawsuits brought in federal and state courts involving claims that plaintiffs have been diagnosed with various injuries following treatment with proton pump inhibitors (PPIs), including Nexium and Prilosec. Most of the lawsuits alleged kidney injury. In August 2017, the pending federal court cases were consolidated in a multidistrict litigation (MDL) proceeding in the US District Court for the District of New Jersey for pre-trial purposes. In addition to the MDL cases, there were cases alleging kidney injury filed in Delaware and New Jersey state courts.
In addition, AstraZeneca has been defending lawsuits involving allegations of gastric cancer following treatment with PPIs, including one such claim in the US District Court for the Middle District of Louisiana (Louisiana District Court).
In October 2023, AstraZeneca resolved all pending claims in the MDL, as well as all pending claims in Delaware and New Jersey state courts, for $425m, for which a provision has been taken. The only remaining case is the one pending in the Louisiana District Court. The Court in that case has postponed trial, which was previously scheduled to begin in April 2024. No new trial date has been set.
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Farxiga and Xigduo XR
US proceedings
AstraZeneca has been named as a defendant in lawsuits involving plaintiffs claiming physical injury, including Fournier's Gangrene and necrotising fasciitis, from treatment with Farxiga and/or Xigduo XR. In September 2023, the parties resolved by settlement agreement one case, filed in state court in Minnesota, previously scheduled for trial in October 2023. All remaining claims are filed in Delaware state court and remain pending.
Nexium and Losec/Prilosec
Canada proceedings
In Canada, in July and August 2017, AstraZeneca was served with three putative class action lawsuits. Two of the lawsuits have been dismissed, one in 2019 and one in 2021. The third lawsuit seeks authorisation to represent individual residents in Canada who allegedly suffered kidney injuries from the use of proton pump inhibitors, including Nexium and Losec.
Onglyza and Kombiglyze
US proceedings
In the US, AstraZeneca is defending various lawsuits alleging heart failure, cardiac injuries, and/or death from treatment with Onglyza or Kombiglyze. In August 2022, the US District Court for the Eastern District of Kentucky, presiding over the consolidated federal cases, granted AstraZeneca’s motion for summary judgment, which plaintiffs have appealed to the US Court of Appeals for the Sixth Circuit. In the California state court proceeding, the trial court granted summary judgment for AstraZeneca, which the California appellate court affirmed. The California Supreme Court has declined further review, so the California state court proceeding has concluded.
Commercial litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
340B Antitrust Litigation
US proceedings
In September 2021, AstraZeneca was served with a class-action antitrust complaint filed in the US District Court for the Western District of New York (District Court) by Mosaic Health alleging a conspiracy to restrict access to 340B discounts in the diabetes market through contract pharmacies. In September 2022, the District Court granted AstraZeneca’s motion to dismiss the Complaint. In February 2024, the District Court denied Plaintiffs’ request to file a new amended complaint and entered an order closing the matter.
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Anti-Terrorism Act Civil Lawsuit
US proceedings
In the US, in October 2017, AstraZeneca and certain other pharmaceutical and/or medical device companies were named as defendants in a complaint filed in the US District Court for the District of Columbia (District Court) by US nationals (or their estates, survivors, or heirs) who were killed or wounded in Iraq between 2005 and 2013. The plaintiffs allege that the defendants violated the US Anti-Terrorism Act and various state laws by selling pharmaceuticals and medical supplies to the Iraqi Ministry of Health. In July 2020, the District Court granted AstraZeneca’s and the other defendants’ motion to dismiss the lawsuit, which the DC Circuit Court of Appeals (the Appellate Court) reversed in January 2022. In February 2023, the Appellate Court denied a request for en banc review. In June 2023, AstraZeneca and the other defendants filed a petition for review by the United States Supreme Court.
Caelum Trade Secrets Litigation
US proceedings
AstraZeneca has been defending a matter filed by the University of Tennessee Research Foundation in the US District Court for the Eastern District of Tennessee (District Court) related to CAEL-101. In October 2023, AstraZeneca filed a motion for summary judgment on all claims and awaits a decision by the District Court. Trial is currently scheduled for September 2024.
Definiens
Germany proceedings
In Germany, in July 2020, AstraZeneca received a notice of arbitration filed with the German Institution of Arbitration from the sellers of Definiens AG (the Sellers) regarding the 2014 Share Purchase Agreement (SPA) between AstraZeneca and the Sellers. The Sellers claim that they are owed approximately $140m in earn-outs under the SPA. The arbitration hearing took place in March 2023 and final post-hearing written briefs were submitted in June 2023. In December 2023, the arbitration panel made a final award of $46.43m in favour of the Sellers. AstraZeneca is considering its options.
Employment Litigation
US proceedings
In December 2022, AstraZeneca was served with a lawsuit filed by seven former employees in the US District Court for the District of Delaware (District Court) asserting age, religion, and disability discrimination claims related to AstraZeneca’s vaccination requirement. In March 2023, AstraZeneca filed a motion to dismiss the religious and disability discrimination claims and a motion to strike the class and collective claims. That motion is fully briefed and the parties are awaiting a decision by the District Court.
Pay Equity Litigation
US proceedings
AstraZeneca was defending a putative class and collective action matter in the US District Court for the Northern District of Illinois (District Court) brought by three named plaintiffs, who are former AstraZeneca employees. The case involved claims under the federal and Illinois Equal Pay Acts, with the plaintiffs alleging they were paid less than male employees who performed substantially similar and/or equal work. In January 2023, the District Court granted AstraZeneca’s motion to dismiss plaintiffs’ complaint. In March 2023, plaintiffs filed a Second Amended Complaint. AstraZeneca moved to dismiss the Second Amended Complaint in April 2023. The motion to dismiss was denied in October 2023, and the parties are proceeding with discovery.
Seroquel XR (Antitrust Litigation)
US proceedings
In 2019, AstraZeneca was named in several related complaints brought in the US District Court for the Southern District of New York (District Court), including several putative class action lawsuits that were purportedly brought on behalf of classes of direct purchasers or end payors of Seroquel XR, that allege AstraZeneca and generic drug manufacturers violated US antitrust laws when settling patent litigation related to Seroquel XR. In July 2022, in response to AstraZeneca’s motion to dismiss, the District Court dismissed all claims relating to the settlement with one of the generic manufacturers but denied the motion with respect to all claims relating to the second generic manufacturer and allowed those claims to proceed. Trial is currently scheduled for May 2025.
Syntimmune
US proceedings
In connection with Alexion’s prior acquisition of Syntimmune, Inc., (Syntimmune) in December 2020, Alexion was served with a lawsuit filed by the stockholders’ representative for Syntimmune in Delaware state court that alleged, among other things, breaches of contractual obligations relating to the 2018 merger agreement. The stockholders’ representative alleges that Alexion failed to meet its obligations under the merger agreement to use commercially reasonable efforts to achieve the milestones. Alexion also filed a claim for breach of the representations in the 2018 merger agreement. A trial was held in July 2023 and a decision is expected in 2024.
Viela Bio, Inc. Shareholder Litigation
US proceedings
In February 2023, AstraZeneca was served with a lawsuit filed in Delaware state court against AstraZeneca and certain officers (collectively, defendants), on behalf of a putative class of Viela Bio, Inc. (Viela) shareholders. The complaint alleges that defendants breached their fiduciary duty to Viela shareholders in the course of Viela’s 2021 merger with Horizon Therapeutics, plc. In May 2023, AstraZeneca filed a motion to dismiss, which is now fully briefed and pending before the Court.
Legal proceedings brought by AstraZeneca considered to be contingent assets
PARP Inhibitor Royalty Dispute
UK proceedings
In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK)) entered into two worldwide, royalty-bearing patent license agreements with AstraZeneca related to GSK’s product niraparib. In May 2021, AstraZeneca filed a lawsuit against GSK in the Commercial Court of England and Wales alleging that GSK has failed to pay all of the royalties due on niraparib sales under the license agreements. The case was transferred to the Chancery Division and a trial took place in March 2023. In April 2023, the court issued a decision in AstraZeneca’s favour. GSK has been granted permission to appeal, and the appellate hearing was held in January 2024.
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Legal proceedings brought against AstraZeneca which have been concluded
Alexion Shareholder Litigation
US proceedings
In December 2016, putative securities class action lawsuits were filed in the US District Court for the District of Connecticut (District Court) against Alexion and certain officers and directors (collectively, defendants), on behalf of purchasers of Alexion publicly traded securities during the period 30 January 2014 through 26 May 2017. The amended complaint alleged that defendants engaged in securities fraud, including by making misrepresentations and omissions in their public disclosures concerning Alexion’s Soliris sales practices, management changes, and related investigations. In August 2021, the District Court issued a decision denying in part defendants’ motion to dismiss the matter. The Court granted plaintiffs’ motion for class certification in April 2023. In August 2023, the parties reached a settlement in principle of this matter. In September 2023, the court granted preliminary approval of the class settlement. A provision was taken in September 2023. The court granted final approval of the class settlement in December 2023, and the matter is now concluded.
AZD1222 Securities Litigation
US proceedings
In January 2021, putative securities class action lawsuits were filed in the US District Court for the Southern District of New York (District Court) against AstraZeneca PLC and certain officers, on behalf of purchasers of AstraZeneca publicly traded securities during a period later amended to cover 15 June 2020 through 29 January 2021. The Amended Complaint alleges that defendants made materially false and misleading statements in connection with the development of AZD1222, AstraZeneca’s vaccine for the prevention of COVID-19. In September 2022, the District Court granted AstraZeneca’s motion to dismiss the Amended Complaint with prejudice. In May 2023, the US Court of Appeals for the Second Circuit affirmed the dismissal. The matter is now concluded.
Portola Shareholder Litigation
US proceedings
In connection with Alexion’s July 2020 acquisition of Portola Pharmaceuticals, Inc. (Portola), Alexion assumed litigation to which Portola is a party. In January 2020, putative securities class action lawsuits were filed in the US District Court for the Northern District of California against Portola and certain officers and directors (collectively, defendants), on behalf of purchasers of Portola publicly traded securities during the period 8 January 2019 through 26 February 2020. The operative complaints alleged that defendants made materially false and/or misleading statements or omissions with regard to Andexxa. In June 2022, the parties reached a settlement in principle of this matter. In March 2023, the court granted final approval of the settlement. The matter is now concluded.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
340B Qui Tam
US proceedings
In July 2023, AstraZeneca was served with an unsealed civil lawsuit brought by a qui tam relator on behalf of the United States, several states, and the District of Columbia in the US District Court for the Central District of California. The complaint alleges that AstraZeneca violated the US False Claims Act (FCA) and state-law analogues. In September 2023, AstraZeneca filed a motion to dismiss the relator’s claims. In response, the relator filed a First Amended Complaint. In December 2023, AstraZeneca filed a motion to dismiss the First Amended Complaint.
340B Administrative Proceedings
US proceedings
In September 2023, the Arkansas Insurance Department sent AstraZeneca an administrative complaint concerning compliance with Arkansas’s 340B Statute, which requires manufacturers to recognize an unlimited number of contract pharmacies.
Previously disclosed Administrative Dispute Resolution proceedings against AstraZeneca remain pending before the US Health Resources and Services Administration.
Brazilian Tax Assessment Matter
Brazil proceedings
In connection with an ongoing matter, in August 2019, the Brazilian Federal Revenue Service provided a Notice of Tax and Description of the Facts (the Tax Assessment) to two Alexion subsidiaries (the Brazil Subsidiaries), as well as to two additional entities – a logistics provider utilised by Alexion and a distributor. The Tax Assessment focuses on the importation of Soliris vials pursuant to Alexion’s free drug supply to patients programme in Brazil.
Alexion prevailed in the first level of administrative appeals in the Brazilian federal administrative proceeding system based on a deficiency in the Brazil Tax Assessment. The decision was subject to an automatic (ex officio) appeal to the second level of the administrative courts. In March 2023, the second level of the administrative courts issued a decision to remand the matter to the first level of administrative courts for a determination on the merits.
Texas Qui Tam
US proceedings
In December 2022, AstraZeneca was served with an unsealed civil lawsuit brought by qui tam relators on behalf of the State of Texas in Texas state court, which alleges that AstraZeneca engaged in unlawful marketing practices. In March 2023, AstraZeneca filed a motion to dismiss and a motion to transfer venue. In response, relators filed an Amended Petition. In May 2023, AstraZeneca filed a motion to dismiss the Amended Petition and renewed its motion to transfer venue. In September 2023, the Texas state court denied AstraZeneca’s motion to transfer venue and motion to dismiss. Trial is currently scheduled for October 2024.
Turkish Ministry of Health Matter
Turkey proceedings
In Turkey, in July 2020, the Turkish Ministry of Health (Ministry of Health) initiated an investigation regarding payments to healthcare providers by Alexion Turkey and former employees and consultants. The investigation arose from Alexion’s disclosure of a $21.5m civil settlement with the US Securities & Exchange Commission (SEC) in July 2020 fully resolving the SEC’s investigation into possible violations of the US Foreign Corrupt Practices Act. In September 2021, the Ministry of Health completed its draft investigation report, and referred the matter to the Ankara Public Prosecutor’s Office with a recommendation for further proceedings against certain former employees.
US Congressional Inquiry
US proceedings
In January 2024, AstraZeneca received a letter from the US Senate Committee on Health, Education, Labor and Pensions (HELP Committee) seeking information related to AstraZeneca's inhaled Respiratory products. AstraZeneca intends to cooperate with the inquiry.
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Vermont US Attorney Investigation
US proceedings
In April 2020, AstraZeneca received a Civil Investigative Demand from the US Attorney’s Office in Vermont and the Department of Justice, Civil Division, seeking documents and information relating to AstraZeneca’s relationships with electronic health-record vendors. AstraZeneca continues to cooperate with this enquiry.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in federal court in Delaware challenging aspects of the drug price negotiation provisions of the Inflation Reduction Act and the implementing guidance and regulations promulgated by the US Department of Health and Human Services.
Louisiana 340B Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit against the State of Louisiana alleging that the Louisiana’s 340B statute, which requires manufacturers to recognize an unlimited number of contract pharmacies, is preempted on several grounds and violates the Contracts Clause of the U.S. Constitution. AstraZeneca and the State of Louisiana have moved for summary judgment on AstraZeneca’s claims.
Legal proceedings brought against AstraZeneca which have been concluded
COVID-19 Vaccine Supply and Manufacturing Inquiries
Brazil proceedings
In February 2022, a Brazilian Public Prosecutor filed a lawsuit against several defendants including the Brazilian Federal Government, AstraZeneca, and other COVID-19 vaccine manufacturers. In April 2022, a Brazilian Court issued an order dismissing the lawsuit. In October 2023, the pending appeal was dismissed. No further appeal was made. This matter is now concluded.
Legal proceedings brought by AstraZeneca which have been concluded
US 340B Litigation
US proceedings
In January 2021, AstraZeneca filed a lawsuit in the US District Court for the District of Delaware (District Court) alleging that an Advisory Opinion issued by the Department of Health and Human Services violates the Administrative Procedure Act. In June 2021, the District Court found in favour of AstraZeneca, invalidating the Advisory Opinion. However, in May 2021, prior to the District Court’s ruling, the US Government issued new and separate letters to AstraZeneca (and other companies) asserting that AstraZeneca’s contract pharmacy policy violates the 340B statute. AstraZeneca amended the complaint to include allegations challenging the letter sent in May 2021, and in February 2022, the District Court ruled in favour of AstraZeneca invalidating those letters sent by the US Government. In January 2023, the Court of Appeals affirmed the District Court’s decision in AstraZeneca’s favour. Final judgment was entered in favour of AstraZeneca in May 2023 and this matter is now concluded.
Other
Additional government inquiries
As is true for most, if not all, major prescription pharmaceutical companies, AstraZeneca is currently involved in multiple inquiries into drug marketing and pricing practices. In addition to the investigations described above, various law enforcement offices have, from time to time, requested information from the Group. There have been no material developments in those matters.
Tax
AstraZeneca considers whether it is probable that a taxation authority will accept an uncertain tax treatment. If it is concluded that it is not probable that the taxation authority will accept an uncertain tax treatment, where tax exposures can be quantified, a tax liability is recognised based on either the most likely amount method or the expected value method depending on which method management expects to better predict the resolution of the uncertainty. Tax liabilities for uncertain tax treatments can be built up over a long period of time but the resolution of such tax exposures usually occurs at a point in time, and given the inherent uncertainties in assessing the outcomes of these exposures (which sometimes can be binary in nature), we could, in future periods, experience adjustments to the liabilities recognised in respect of uncertain tax treatments that have a material positive or negative effect on our results in any particular period. Details of the movements in relation to material uncertain tax treatments are discussed below.
AstraZeneca faces a number of audits and reviews in jurisdictions around the world and, in some cases, is in dispute with the tax authorities. The issues under discussion are often complex and can require many years to resolve. Tax liabilities recognised for uncertain tax treatments require management to make key judgements with respect to the outcome of current and potential future tax audits, and actual results could vary from these estimates. Management does not believe a significant risk of material change to uncertain tax positions exists in the next 12 months.
The total net tax liability recognised in the Group Financial Statements in respect of uncertain tax positions is $1,336m (2022: $830m; 2021: $768m). The net tax liability consists of $1,241m (2022: $632m; 2021: $702m) included within income tax payable, $441m (2022: $291m; 2021: $(33)m) included within deferred tax asset, partially offset by $9m (2022: $(20)m; 2021: $(17)m) included within deferred tax liabilities, and $337m (2022: $113m; 2021: additional $82m) included within income tax receivable.
Transfer pricing
The net tax liability included in the Group Financial Statements to cover the worldwide exposure to uncertain tax treatments is $401m (2022: $260m; 2021: $77m). The increase in the net tax liability for uncertain tax positions relating to transfer pricing of $141m compared with 2022 is mainly as a result of an increase of tax liabilities arising from updates to estimates of prior period tax liabilities following progression of tax authority reviews.
These matters can be complex and judgemental. The liability includes uncertain tax treatments which are estimated using the expected value method and depend on AstraZeneca’s assessment of the likelihood of the approach taken by the tax authorities and could change in the future to reflect progress in tax authority reviews, the extent that any tax authority challenge is concluded, or matters lapse including following expiry of the relevant statutes of limitation resulting in a reduction in the tax charge in future periods.
For transfer pricing matters, including items under tax audit, AstraZeneca estimates the potential for additional tax liabilities above the amount provided where the possibility of the additional liabilities falling due is more than remote, to be up to $386m (2022: $245m; 2021: $48m) including associated interest.
Management believes that it is unlikely that these additional liabilities will arise. It is possible that some of these contingencies may change in the future to reflect progress in tax authority reviews, to the extent that any tax authority challenge is concluded or matters lapse including following expiry of the relevant statutes of limitation resulting in a reduction in the tax charge in future periods. Management continues to believe that AstraZeneca’s positions on all its transfer pricing positions, audits and disputes are robust, and that AstraZeneca has recognised appropriate tax balances, including consideration of whether corresponding relief will be available under Mutual Agreement procedures or unilaterally.
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Other uncertain tax treatments
Included in the net tax liability is $935m (2022: $570m; 2021: $691m) relating to a number of other uncertain tax treatments. The increase of $365m in the net tax liability relating to the other uncertain tax treatments mainly relates to an update to tax liabilities following progress of reviews by tax authorities and administrative appeal processes. The liability includes tax liabilities in respect of uncertain tax treatments which are estimated using the most likely amount method and the expected value method and depend on AstraZeneca’s assessment of the likelihood of the approach taken by the tax authorities. This could change in the future to reflect progress in tax authority reviews, the extent that any tax authority challenge is concluded, or matters lapse including following expiry of the relevant statutes of limitation resulting in a reduction in the tax charge in future periods.
For these other tax liabilities in respect of uncertain tax treatments, AstraZeneca estimates the potential for additional liabilities above the amount provided where the possibility of the additional liabilities falling due is more than remote, to be up to $293m (2022: $209m; 2021: $273m) including associated interest. It is possible that some of these liabilities may reduce in the future if any tax authority challenge is concluded or matters lapse following expiry of the relevant statutes of limitation, resulting in a reduction in the tax charge in future periods. AstraZeneca does not believe there are any significant other uncertain tax treatments where the possibility of the additional liabilities falling due is more than remote (2022: $280m; 2021: $325m) including associated interest.
Timing of cash flows and interest
The Group is currently under audit in several countries and the timing of any resolution of these audits is uncertain.
It is anticipated that tax payments may be required in relation to a number of significant disputes which may be resolved over the next one to two years. AstraZeneca considers the tax liabilities set out above to appropriately reflect the expected value of any final settlement. Some of the items discussed above are not currently within the scope of tax authority audits and may take longer to resolve.
Included within other payables is a net amount of interest arising on tax contingencies of $184m (2022: $106m; 2021: $85m).
31 Statutory and other information
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2023 |
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2022 |
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2021 |
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$m |
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$m |
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$m |
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Fees payable to PricewaterhouseCoopers LLP and its associates: |
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|
|
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|
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Group audit fee |
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10.2 |
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9.9 |
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10.5 |
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Fees payable to PricewaterhouseCoopers LLP and its associates for other services: |
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|
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|
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The audit of subsidiaries pursuant to legislation |
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15.0 |
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15.1 |
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15.2 |
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Attestation under s404 of Sarbanes-Oxley Act 2002 |
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3.3 |
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3.1 |
|
2.0 |
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Audit-related assurance services |
|
1.1 |
|
0.7 |
|
4.5 |
|
Other assurance services |
|
0.2 |
|
0.2 |
|
3.4 |
|
Fees payable to PricewaterhouseCoopers Associates in respect of the Group’s pension schemes: |
|
|
|
|
|
|
|
The audit of subsidiaries’ pension schemes |
|
0.3 |
|
0.3 |
|
0.3 |
|
|
|
30.1 |
|
29.3 |
|
35.9 |
|
$0.7m of fees payable in 2023 are in respect of the Group audit and audit of subsidiaries related to prior years (2022: $0.6m in respect of the Group audit and audit of subsidiaries related to prior years).
$0.3m of 2021 Group audit fees and $0.7m of 2021 Audit-related assurance services and Other assurance services relate to pre-acquisition fees incurred by Alexion.
Included in the 2021 Audit-related assurance services and Other assurance services are $6.1m of services provided in relation to the acquisition of Alexion and related debt issuance.
Related party transactions
The Group had no material related party transactions which might reasonably be expected to influence decisions made by the users of these Financial Statements.
Key management personnel compensation
Key management personnel are defined for the purpose of disclosure under IAS 24 ‘Related Party Disclosures’ as the members of the Board and the members of the SET.
|
|
2023 |
|
2022 |
|
2021 |
|
|
|
$’000 |
|
$’000 |
|
$’000 |
|
Short-term employee benefits |
|
38,636 |
|
38,632 |
|
32,985 |
|
Post-employment benefits |
|
1,354 |
|
1,388 |
|
1,378 |
|
Share-based payments |
|
58,242 |
|
56,297 |
|
45,234 |
|
|
|
98,232 |
|
96,317 |
|
79,597 |
|
Total remuneration is included within employee costs (see Note 29).
32 Subsequent events
There were no material subsequent events.
F-61
Group Subsidiaries and Holdings
In accordance with section 409 of the Companies Act 2006 a full list of subsidiaries, partnerships, associates, joint ventures and joint arrangements, the place of incorporation, registered office address, and the effective percentage of equity owned as at 31 December 2023 are disclosed below. Unless otherwise stated, the share capital disclosed comprises ordinary shares which are indirectly held by AstraZeneca PLC.
Unless otherwise stated, the accounting year ends of subsidiaries are 31 December. The Group Financial Statements consolidate the Financial Statements of the Company and its subsidiaries at 31 December 2023.
At 31 December 2023 |
|
Group Interest |
|
Wholly owned subsidiaries |
|
|
|
|
|
|
|
Algeria |
|
|
|
AAPM SARL |
|
100 |
% |
Number 20, Micro-Economic Zone, Hydra Business Center, Dar El Medina, Algiers, Algeria |
|
|
|
|
|
|
|
Argentina |
|
|
|
AstraZeneca S.A. |
|
100 |
% |
Olga Cossettini 363, 3° floor, Buenos Aires, Argentina |
|
|
|
Alexion Pharma Argentina SRL |
|
100 |
% |
Avenida Leandro N. Alem 592 Piso 6, Buenos Aires, Argentina |
|
|
|
|
|
|
|
Australia |
|
|
|
AstraZeneca Holdings Pty Limited |
|
100 |
% |
AstraZeneca Pty Limited |
|
100 |
% |
Alexion Pharmaceuticals Australasia Pty Ltd |
|
100 |
% |
66 Talavera Road, Macquarie Park, NSW 2113, Australia |
|
|
|
LogicBio Australia Pty Limited |
|
100 |
% |
Level 40, 2-26 Park Street, Sydney, NSW 2000, Australia |
|
|
|
|
|
|
|
Austria |
|
|
|
AstraZeneca Österreich GmbH |
|
100 |
% |
A-1120 Wien, Rechte Wienzeile 223 Tür 16.1, Austria |
|
|
|
Alexion Pharma Austria GmbH |
|
100 |
% |
Donau-City-Straße 7, 30. Stock, DC Tower, Vienna 1220, Austria |
|
|
|
Portola Österreich GmbH (in liquidation) |
|
100 |
% |
Mooslackengasse 17, 1190 Wien, Austria |
|
|
|
|
|
|
|
Belgium |
|
|
|
AstraZeneca S.A. / N.V. |
|
100 |
% |
Alfons Gossetlaan 40 bus 201 at 1702 Groot-Bijgaarden, Belgium |
|
|
|
Alexion Pharma Belgium Sprl |
|
100 |
% |
Alexion Services Europe Sprl |
|
100 |
% |
de Meeûssquare 37, Bruxelles 1000, Belgium |
|
|
|
|
|
|
|
Bermuda |
|
|
|
Alexion Bermuda Holding ULC |
|
100 |
% |
Alexion Bermuda Limited |
|
100 |
% |
Alexion Bermuda Partners LP |
|
100 |
% |
Canon's Court, 22 Victoria St., Hamilton, Bermuda |
|
|
|
|
|
|
|
Brazil |
|
|
|
AstraZeneca do Brasil Limitada |
|
100 |
% |
Rod. Raposo Tavares, KM 26, 9, Cotia, Brazil |
|
|
|
Alexion Farmacêutica América Latina Serviços de Administração de Vendas Ltda. |
|
100 |
% |
Alexion Serviços e Farmacêutica do Brasil Ltda. |
|
100 |
% |
Av. Dr Chucri Zaidan, 1240, 15° andar, CEP 04711-130, Ed. Morumbi Corporate – Golden Tower Vila São Francisco, São Paulo, Brazil |
|
|
|
|
|
|
|
Bulgaria |
|
|
|
AstraZeneca Bulgaria EOOD |
|
100 |
% |
1057 Sofia, Izgrev Region, 36 Dragan Tsankov Blvrd, Bulgaria |
|
|
|
|
|
|
|
Canada |
|
|
|
AstraZeneca Canada Inc.1 |
|
100 |
% |
Suite 5000, 1004 Middlegate Road, Mississanga, ON, L4Y 1M4, Canada |
|
|
|
Alexion Pharma Canada Corporation |
|
100 |
% |
1300-1969 ST Upper Water, Halifax, NS, B3J 3R7, Canada |
|
|
|
|
|
|
|
Cayman Islands |
|
|
|
AZ Reinsurance Limited |
|
100 |
% |
18 Forum Lane, 2nd Floor, Camana Bay, Grand Cayman, P.O. Box 69, Cayman Islands |
|
|
|
Grey Wolf Merger Sub |
|
100 |
% |
PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands |
|
|
|
|
|
|
|
Chile |
|
|
|
AstraZeneca S.A. |
|
100 |
% |
AstraZeneca Farmaceutica Chile Limitada |
|
100 |
% |
Av. Isidora Goyenechea 3477, 2nd Floor, Las Condes, Santiago, Chile |
|
|
|
|
|
|
|
China |
|
|
|
AstraZeneca Pharmaceutical Co., Limited |
|
100 |
% |
No. 2, Huangshan Road, Wuxi, Jiangsu Province, China |
|
|
|
AstraZeneca (Wuxi) Trading Co. Ltd |
|
100 |
% |
Building E, Huirong Plaza, Jinghui Road East, Xinwu District, Wuxi, Jiangsu Province, China |
|
|
|
AstraZeneca Investment (China) Co., Ltd |
|
100 |
% |
199 Liangjing Road, China (Shanghai) Pilot Free Trade Zone, Shanghai, China |
|
|
|
AstraZeneca Pharmaceutical (China) Co. Ltd |
|
100 |
% |
No. 9, Medical Avenue, Jiangsu Province, Taizhou, China |
|
|
|
AstraZeneca Pharmaceutical (Beijing) Co., Ltd |
|
100 |
% |
1F, Building No. 4, No. 8 Courtyard, No. 1 Kegu Street, Beijing Economic-Technological Development Area, Beijing 100176, China |
|
|
|
AstraZeneca (Guangzhou) Pharmaceutical Co., Ltd |
|
100 |
% |
Room 406-178, No. 1, Yichuang Street, (China-Singapore Guangzhou Knowledge City) Huangpu District, Guangzhou City, China |
|
|
|
AstraZeneca Investment Consulting (Wuxi) Co., Ltd |
|
100 |
% |
Room 808, 8F, Building 99-2 Linghu Avenue, Xinwu District, Wuxi, Jiangsu, China |
|
|
|
AstraZeneca Pharmaceutical (Hangzhou) Co., Ltd |
|
100 |
% |
12F & 14F, Building 1, Shuli Plaza, 758 Fei Jia Tang Road, Gongshu District, Hangzhou, Zhejiang Province, China |
|
|
|
AstraZeneca Global R&D (China) Co., Ltd |
|
100 |
% |
16F, 88 Xizang North Road, Jing’an District, Shanghai, China |
|
|
|
AstraZeneca Pharmaceutical (Chengdu) Co., Ltd |
|
100 |
% |
10th Floor, Building 11 (Building E11), No. 366, Hemin Street, Chengdu High-tech Zone, China (Sichuan) Pilot Free Trade Zone, China |
|
|
|
AstraZeneca Pharmaceutical (Shanghai) Co., Ltd |
|
100 |
% |
B1F, 8F & 9F, 88 Xizang North Road, Jing’an District, Shanghai, China |
|
|
|
Alexion Pharmaceuticals (Shanghai) Company Limited |
|
100 |
% |
Room 702, No. 1539 West Nanjing Road, Jing'an District, Shanghai, China |
|
|
|
AstraZeneca Pharmaceutical Manufacturing (Qingdao) Co., Ltd. |
|
100 |
% |
AstraZeneca Pharmaceutical (Qingdao) Co., Ltd. |
|
100 |
% |
Room 806, Building 2, No. 82 Juxianqiao Road, High-tech Zone, Qingdao City, Shandong Province, China |
|
|
|
|
|
|
|
Colombia |
|
|
|
AstraZeneca Colombia S.A.S. |
|
100 |
% |
Av Carrera 9 No. 101-67 Office 601, Bogotá, 110231, Colombia |
|
|
|
Alexion Pharma Colombia S.A.S. |
|
100 |
% |
Carrera 9 No. 115 - 06 /30 Edificio Tierra Firme Oficina 2904 Bogotá D.C., Colombia |
|
|
|
|
|
|
|
|
|
|
|
Costa Rica |
|
|
|
AstraZeneca CAMCAR Costa Rica, S.A. |
|
100 |
% |
San José, Escazú, Roble Corporate Center, 5to piso, Costa Rica |
|
|
|
|
|
|
|
Croatia |
|
|
|
AstraZeneca d.o.o. |
|
100 |
% |
Radnicka cesta 80, 10000 Zagreb, Croatia |
|
|
|
|
|
|
|
Czech Republic |
|
|
|
AstraZeneca Czech Republic, s.r.o. |
|
100 |
% |
U Trezorky 921/2, 158 00 Prague 5, Czech Republic |
|
|
|
Alexion Pharma Czech s.r.o. |
|
100 |
% |
Novodvorská 994/138, Braník, 142 00 Prague, Czech Republic |
|
|
|
|
|
|
|
Denmark |
|
|
|
AstraZeneca A/S |
|
100 |
% |
Johanne Møllers Passage 1, Dk-1799 Copenhagen V, Denmark |
|
|
|
|
|
|
|
Egypt |
|
|
|
AstraZeneca Egypt for Pharmaceutical Industries SAE |
|
100 |
% |
6th of October City, 6th Industrial Zone, Plot 2, Giza, Egypt |
|
|
|
AstraZeneca Egypt LLC |
|
100 |
% |
47 St. 270 New Maadi, Cairo, Egypt |
|
|
|
Drimex LLC |
|
100 |
% |
Plot 133, Banks’ District, 5th Settlement, New Cairo, Cairo, Egypt |
|
|
|
|
|
|
|
Estonia |
|
|
|
AstraZeneca Eesti OÜ |
|
100 |
% |
Harju maakond, Tallinn, Lasnamäe linnaosa, Valukoja tn 8/1, 11415, Estonia |
|
|
|
|
|
|
|
Finland |
|
|
|
AstraZeneca Oy. |
|
100 |
% |
Keilaranta 18, 02150 Espoo, Finland |
|
|
|
|
|
|
|
France |
|
|
|
AstraZeneca SAS |
|
100 |
% |
Tour Carpe Diem-31, Place des Corolles, 92400 Courbevoie, France |
|
|
|
AstraZeneca Reims Production SAS |
|
100 |
% |
F-62
Chemin de Vrilly Parc, Industriel de la Pompelle, Reims, 51100, France |
|
|
|
AstraZeneca Dunkerque Production SCS |
|
100 |
% |
224 Avenue de la Dordogne, 59640 Dunkerque, France |
|
|
|
Alexion Europe SAS |
|
100 |
% |
Alexion Pharma France SAS |
|
100 |
% |
103-105 Rue Anatole France 92300 Levallois-Perret, France |
|
|
|
|
|
|
|
Germany |
|
|
|
AstraZeneca Holding GmbH |
|
100 |
% |
AstraZeneca GmbH |
|
100 |
% |
Friesenweg 26, 22763, Hamburg, Germany |
|
|
|
Sofotec GmbH |
|
100 |
% |
Benzstrasse 1-3, 61352, Bad Homburg v.d. Hohe, Germany |
|
|
|
AstraZeneca Computational Pathology GmbH2 |
|
100 |
% |
Bernhard-Wicki-Straße 5, 80636, Munich, Germany |
|
|
|
Alexion Pharma Germany GmbH |
|
100 |
% |
Landsberger Straße 300, 80687, Munich, Germany |
|
|
|
|
|
|
|
Greece |
|
|
|
AstraZeneca S.A. |
|
100 |
% |
Agisilaou 6-8 Marousi, Athens, Greece |
|
|
|
|
|
|
|
Hong Kong |
|
|
|
AstraZeneca Hong Kong Limited |
|
100 |
% |
Unit 1 – 3, 11/F., China Taiping Finance Centre, 18 King Wah Road, North Point, Hong Kong |
|
|
|
|
|
|
|
Hungary |
|
|
|
AstraZeneca Kft |
|
100 |
% |
1st floor, 4 building B, Alíz str., Budapest, 1117, Hungary |
|
|
|
|
|
|
|
India |
|
|
|
AstraZeneca India Private Limited3 |
|
100 |
% |
Block A, Neville Tower, 11th Floor, Ramanujan IT SEZ, Taramani, Chennai, Tamil Nadu, PIN 600113, India |
|
|
|
Alexion Business Services Private Limited |
|
100 |
% |
9th Floor, Platina, G Block Plot No. C-59, Bandra-Kurla Complex Bandra (East), Mumbai 400051, India |
|
|
|
|
|
|
|
Iran |
|
|
|
AstraZeneca Pars Company |
|
100 |
% |
Suite 1, 1st Floor No. 39, Alvand Ave., Argantin Sq., Tehran 1516673114, Iran |
|
|
|
|
|
|
|
Ireland |
|
|
|
AstraZeneca Pharmaceuticals (Ireland) Designated Activity Company |
|
100 |
% |
4th Floor, South Bank House, Barrow Street, Dublin, 4, Republic of Ireland |
|
|
|
Alexion Pharma Holding Limited |
|
100 |
% |
Alexion Pharma International Operations Limited |
|
100 |
% |
Alexion Pharma Development Limited |
|
100 |
% |
AstraZeneca Ireland Limited |
|
100 |
% |
College Business & Technology Park, Blanchardstown Road North, Dublin 15, Republic of Ireland |
|
|
|
|
|
|
|
Israel |
|
|
|
AstraZeneca (Israel) Ltd |
|
100 |
% |
Atirei Yeda 1, Building O-Tech 2, POB 8044, Kfar Saba, 4464301, Israel |
|
|
|
Alexion Pharma Israel Ltd |
|
100 |
% |
4 Weizmann Str., Tel-Aviv-Jaffa, Israel |
|
|
|
|
|
|
|
Italy |
|
|
|
Simesa SpA |
|
100 |
% |
AstraZeneca SpA |
|
100 |
% |
Alexion Pharma Italy Srl |
|
100 |
% |
Viale Decumano 39, 20157 Milan, Italy |
|
|
|
|
|
|
|
Japan |
|
|
|
AstraZeneca K.K. |
|
100 |
% |
Grand Front Osaka Tower B, 3-1, Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan |
|
|
|
Alexion Pharma GK |
|
100 |
% |
Ebisu First Square, 18-14, Ebisu 1-chome, Shibuya-ku, Tokyo, Japan |
|
|
|
|
|
|
|
Kazakhstan |
|
|
|
AstraZeneca Kazakhstan LLP |
|
100 |
% |
Office 101, 77 Kunayev Street, Almaty 050000, Kazakhstan |
|
|
|
|
|
|
|
Kenya |
|
|
|
AstraZeneca Pharmaceuticals Limited |
|
100 |
% |
L.R. No.1/1327, Avenue 5, 1st Floor, Rose Avenue, Nairobi, Kenya |
|
|
|
|
|
|
|
Latvia |
|
|
|
AstraZeneca Latvija SIA |
|
100 |
% |
Skanstes iela 50, Riga, LV-1013, Latvia |
|
|
|
|
|
|
|
Lithuania |
|
|
|
AstraZeneca Lietuva UAB |
|
100 |
% |
Spaudos g., Vilnius, LT-05132, Lithuania |
|
|
|
|
|
|
|
Luxembourg |
|
|
|
AstraZeneca Luxembourg S.A. |
|
100 |
% |
Rue Nicolas Bové 2A – L-1253, Luxembourg |
|
|
|
|
|
|
|
Malaysia |
|
|
|
AstraZeneca Asia-Pacific Business Services Sdn Bhd |
|
100 |
% |
12th Floor, Menara Symphony, No. 5 Jalan Prof, Khoo Kay Kim, Seksyen 13, 46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia |
|
|
|
AstraZeneca Sdn Bhd |
|
100 |
% |
Nucleus Tower, Level 11 & 12, No. 10 Jalan PJU 7/6, Mutiara Damansara, 47800 Petaling Jaya, Selangor Darul Ehsan, Malaysia |
|
|
|
|
|
|
|
Mexico |
|
|
|
AstraZeneca Health Care Division, S.A. de C.V. |
|
100 |
% |
AstraZeneca, S.A. de C.V. |
|
100 |
% |
Av. Periferico Sur 4305 interior 5, Colonia Jardines en la Montaña, Mexico City, Tlalpan Distrito Federal, CP 14210, Mexico |
|
|
|
Alexion Pharma Mexico S. de R.L. de C.V. |
|
100 |
% |
Paseo de los Tamarindos 90, Torre 1 piso 6 - A Col., Bosques de la Lomas, CP 05120 D.F, Mexico |
|
|
|
|
|
|
|
Morocco |
|
|
|
AstraZeneca Maroc SARLAU |
|
100 |
% |
92 Boulevard Anfa ETG 2, Casablanca 20000, Morocco |
|
|
|
|
|
|
|
The Netherlands |
|
|
|
AstraZeneca B.V. |
|
100 |
% |
AstraZeneca Continent B.V. |
|
100 |
% |
AstraZeneca Gamma B.V. |
|
100 |
% |
AstraZeneca Holdings B.V. |
|
100 |
% |
AstraZeneca Jota B.V. |
|
100 |
% |
AstraZeneca Rho B.V. |
|
100 |
% |
AstraZeneca Sigma B.V. |
|
100 |
% |
AstraZeneca Treasury B.V. |
|
100 |
% |
AstraZeneca Zeta B.V. |
|
100 |
% |
Prinses Beatrixlaan 582, 2595BM, The Hague, The Netherlands |
|
|
|
AstraZeneca Nijmegen B.V. |
|
100 |
% |
Lagelandseweg 78, 6545 CG Nijmegen, The Netherlands |
|
|
|
Acerta Pharma B.V. |
|
100 |
% |
Aspire Therapeutics B.V. |
|
100 |
% |
Kloosterstraat 9, 5349 AB, Oss, The Netherlands |
|
|
|
Portola Netherlands B.V. |
|
100 |
% |
Prins Bernhardplein 200 JB Amsterdam 1097, The Netherlands |
|
|
|
Alexion Holding B.V. |
|
100 |
% |
Alexion Pharma Foreign Holdings B.V. |
|
100 |
% |
Alexion Pharma Netherlands B.V. |
|
100 |
% |
Prinses Beatrixlaan 582, 5895 BM, The Hague, The Netherlands |
|
|
|
Neogene Therapeutics B.V. |
|
100 |
% |
Science Park 106, 1098 XG Amsterdam, The Netherlands |
|
|
|
At 31 December 2023 |
|
Group Interest |
|
New Zealand |
|
|
|
AstraZeneca Limited |
|
100 |
% |
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics, 58 Richard Pearse Drive, Mangere, Auckland, 1142, New Zealand |
|
|
|
|
|
|
|
Nigeria |
|
|
|
AstraZeneca Nigeria Limited |
|
100 |
% |
11A, Alfred Olaiya Street, Awuse Estate, Off Salvation Street, Opebi, Ikeja, Lagos, Nigeria |
|
|
|
|
|
|
|
Norway |
|
|
|
AstraZeneca AS |
|
100 |
% |
Karvesvingen 7, 0579 Oslo, Norway |
|
|
|
|
|
|
|
Pakistan |
|
|
|
AstraZeneca Pharmaceuticals Pakistan (Private) Limited4 |
|
100 |
% |
Office No 1, 2nd Floor, Sasi Arcade, Block 7, Main Clifton Road, Karachi, Pakistan |
|
|
|
|
|
|
|
Panama |
|
|
|
AstraZeneca CAMCAR, S.A. |
|
100 |
% |
Bodega #1, Parque Logistico MIT, Carretera Hacia Coco Solo, Colon, Panama |
|
|
|
|
|
|
|
Peru |
|
|
|
AstraZeneca Peru S.A. |
|
100 |
% |
Calle Las Orquídeas N° 675, Int. 802, Edificio Pacific Tower, San Isidro, Lima, Peru |
|
|
|
|
|
|
|
Philippines |
|
|
|
AstraZeneca Pharmaceuticals (Phils.) Inc. |
|
100 |
% |
16th Floor, Inoza Tower, 40th Street, Bonifacio Global City, Taguig 1634, Philippines |
|
|
|
|
|
|
|
Poland |
|
|
|
AstraZeneca Pharma Poland Sp.z.o.o. |
|
100 |
% |
Alexion Pharma Poland Sp.z.o.o. |
|
100 |
% |
Postepu 14, 02-676, Warszawa, Poland |
|
|
|
|
|
|
|
Portugal |
|
|
|
Astra Alpha Produtos Farmacêuticos Lda |
|
100 |
% |
AstraZeneca Produtos Farmacêuticos Lda |
|
100 |
% |
Novastra Promoção e Comércio Farmacêutico Lda |
|
100 |
% |
Novastuart Produtos Farmacêuticos Lda |
|
100 |
% |
Stuart-Produtos Farmacêuticos Lda |
|
100 |
% |
Zeneca Epsilon – Produtos Farmacêuticos Lda |
|
100 |
% |
Zenecapharma Produtos Farmacêuticos, Unipessoal Lda |
|
100 |
% |
Rua Humberto Madeira, No 7, Queluz de Baixo, 2730-097, Barcarena, Portugal |
|
|
|
|
|
|
|
Puerto Rico |
|
|
|
IPR Pharmaceuticals, Inc. |
|
100 |
% |
Road 188, San Isidro Industrial Park, Canóvanas, 00729, Puerto Rico |
|
|
|
|
|
|
|
Romania |
|
|
|
AstraZeneca Pharma S.R.L. |
|
100 |
% |
Bucharest, 1A Tipografilor Street, MUSE Offices, 2nd and |
|
|
|
F-63
3rd Floor, District 1, 013714, Romania |
|||
|
|
|
|
Russia |
|
|
|
AstraZeneca Industries, LLC |
|
100 |
% |
8 1st Vostochniy lane, Dobrino village, Borovskiy district, Kaluga region 249006, Russian Federation |
|
|
|
AstraZeneca Pharmaceuticals, LLC |
|
100 |
% |
Building 1, 21 First Krasnogvardeyskiy lane, floor 30, rooms 13 and 14, Moscow, 123112, Russian Federation |
|
|
|
Alexion Pharma OOO LLC |
|
100 |
% |
Building 1, 21 First Krasnogvardeyskiy lane, floor 29, Moscow, 123112, Russian Federation |
|
|
|
|
|
|
|
Saudi Arabia |
|
|
|
AstraZeneca Continent - Regional Headquarter |
|
100 |
% |
Al-Nakhlah Tower, Floor 13th Ath Thumamah Road, Al Sahafa District., P.O. Box 42150, Riyadh, Kingdom of Saudi Arabia |
|
|
|
AstraZeneca Trading Company |
|
100 |
% |
125 Prince Sultan, 2086 Ar Rawdah District, 23435, Jeddah, Kingdom of Saudi Arabia |
|
|
|
|
|
|
|
Singapore |
|
|
|
AstraZeneca Singapore Pte Limited |
|
100 |
% |
10 Kallang Avenue #12-10, Aperia Tower 2, 339510, Singapore |
|
|
|
|
|
|
|
South Africa |
|
|
|
AstraZeneca Pharmaceuticals (Pty) Limited |
|
100 |
% |
17 Georgian Crescent West, Northdowns Office Park, Bryanston, 2191, South Africa |
|
|
|
|
|
|
|
South Korea |
|
|
|
AstraZeneca Korea Co. Ltd |
|
100 |
% |
21st Floor, Asem Tower, 517, Yeongdong-daero, Gangnam-gu, Seoul, 06164, Republic of Korea |
|
|
|
Alexion Pharma Korea LLC |
|
100 |
% |
41 FL., 152 Teheran-ro (Yeoksam-dong Gangnam Finance Center), Gangnam-gu, Seoul, Republic of Korea |
|
|
|
|
|
|
|
Spain |
|
|
|
AstraZeneca Farmaceutica Holding Spain, S.A. |
|
100 |
% |
AstraZeneca Farmaceutica Spain S.A. |
|
100 |
% |
Laboratorio Beta, S.A. |
|
100 |
% |
Laboratorio Lailan, S.A. |
|
100 |
% |
Laboratorio Tau, S.A. |
|
100 |
% |
Fundación AstraZeneca |
|
100 |
% |
Calle del Puerto de Somport, 21-23, 28050, Madrid, Spain |
|
|
|
Alexion Pharma Spain S.L. |
|
100 |
% |
Av Diagonal Num.601 P.1, Barcelona 08028, Spain |
|
|
|
|
|
|
|
Sweden |
|
|
|
Astra Export & Trading Aktiebolag |
|
100 |
% |
Astra Lakemedel Aktiebolag |
|
100 |
% |
AstraZeneca AB |
|
100 |
% |
AstraZeneca Biotech AB |
|
100 |
% |
AstraZeneca BioVentureHub AB |
|
100 |
% |
AstraZeneca Holding Aktiebolag5 |
|
100 |
% |
AstraZeneca International Holdings Aktiebolag6 |
|
100 |
% |
AstraZeneca Nordic AB |
|
100 |
% |
AstraZeneca Pharmaceuticals Aktiebolag |
|
100 |
% |
AstraZeneca Södertälje 2 AB |
|
100 |
% |
Stuart Pharma Aktiebolag |
|
100 |
% |
Tika Lakemedel Aktiebolag |
|
100 |
% |
SE-151 85 Södertälje, Sweden |
|
|
|
Aktiebolaget Hassle |
|
100 |
% |
Symbicom Aktiebolag6 |
|
100 |
% |
431 83 MoIndal, Sweden |
|
|
|
Astra Tech International Aktiebolag |
|
100 |
% |
Box 14, 431 21 MoIndal, Sweden |
|
|
|
Alexion Pharma Nordics Holding AB |
|
100 |
% |
Alexion Pharma Nordics AB |
|
100 |
% |
Kungsgatan 3, Stockholm 111 43, Sweden |
|
|
|
|
|
|
|
Switzerland |
|
|
|
AstraZeneca AG |
|
100 |
% |
Evinova AG |
|
100 |
% |
Neuhofstrasse 34, 6340 Baar, Switzerland |
|
|
|
Spirogen Sarl6 |
|
100 |
% |
Rue du Grand-Chêne 5, CH-1003 Lausanne, Switzerland |
|
|
|
Alexion Pharma GmbH |
|
100 |
% |
Giesshübelstrasse 30, Zürich 8045, Switzerland |
|
|
|
|
|
|
|
Taiwan |
|
|
|
AstraZeneca Taiwan Limited |
|
100 |
% |
21st Floor, Taipei Metro Building 207, Tun Hwa South Road, SEC 2 Taipei, Taiwan |
|
|
|
Alexion Pharma Taiwan Ltd |
|
100 |
% |
Room 1153, 11F, No. 1, SongZhi Rd, Taipei 11047, Taiwan |
|
|
|
|
|
|
|
Thailand |
|
|
|
AstraZeneca (Thailand) Limited |
|
100 |
% |
Asia Centre 19th floor, 173/20, South Sathorn Rd, Khwaeng Thungmahamek, Khet Sathorn, Bangkok, 10120, Thailand |
|
|
|
|
|
|
|
Tunisia |
|
|
|
AstraZeneca Tunisie SaRL |
|
100 |
% |
Lot n°1.5.5 les jardins du lac, bloc B les berges du lac Tunis, Tunisia |
|
|
|
|
|
|
|
Turkey |
|
|
|
AstraZeneca Ilac Sanayi ve Ticaret Limited Sirketi |
|
100 |
% |
YKB Plaza, B Blok, Kat:3-4, Levent/Beşiktaş, Istanbul, Turkey |
|
|
|
Zeneca Ilac Sanayi ve Ticaret Anonim Sirketi |
|
100 |
% |
Büyükdere Cad., Y.K.B. Plaza, B Blok, Kat:4, Levent/Beşiktaş, Istanbul, Turkey |
|
|
|
Alexion Ilac Ticaret Limited Sirketi |
|
100 |
% |
İçerenköy Mahellisi Umut SK. and Ofis Sit. No: 10 12/73 Ataşehir, Istanbul 10-12/73, Turkey |
|
|
|
|
|
|
|
Ukraine |
|
|
|
AstraZeneca Ukraina LLC |
|
100 |
% |
54 Simi Prakhovykh street, Kyiv, 01033, Ukraine |
|
|
|
|
|
|
|
United Arab Emirates |
|
|
|
AstraZeneca FZ-LLC |
|
100 |
% |
P.O. Box 505070, Block D, Dubai Healthcare City, Oud Mehta Road, Dubai, United Arab Emirates |
|
|
|
Alexion Pharma Middle East FZ-LLC |
|
100 |
% |
Dubai Science Park, 501, Floor 5, EIB Building No. 2, Dubai, United Arab Emirates |
|
|
|
|
|
|
|
United Kingdom |
|
|
|
Ardea Biosciences Limited |
|
100 |
% |
Arrow Therapeutics Limited |
|
100 |
% |
Astra Pharmaceuticals Limited |
|
100 |
% |
AstraPharm6 |
|
100 |
% |
AstraZeneca China UK Limited |
|
100 |
% |
AstraZeneca Death In Service Trustee Limited |
|
100 |
% |
AstraZeneca Employee Share Trust Limited |
|
100 |
% |
AstraZeneca Finance Limited |
|
100 |
% |
AstraZeneca Intermediate Holdings Limited5 |
|
100 |
% |
AstraZeneca Investments Limited |
|
100 |
% |
AstraZeneca Japan Limited |
|
100 |
% |
AstraZeneca Nominees Limited |
|
100 |
% |
AstraZeneca Quest Limited |
|
100 |
% |
AstraZeneca Share Trust Limited |
|
100 |
% |
AstraZeneca Sweden Investments Limited |
|
100 |
% |
AstraZeneca Treasury Limited6 |
|
100 |
% |
AstraZeneca UK Limited |
|
100 |
% |
AstraZeneca US Investments Limited5 |
|
100 |
% |
AZENCO2 Limited |
|
100 |
% |
AZENCO4 Limited |
|
100 |
% |
Cambridge Antibody Technology Group Limited |
|
100 |
% |
KuDOS Horsham Limited |
|
100 |
% |
KuDOS Pharmaceuticals Limited |
|
100 |
% |
Zenco (No. 8) Limited |
|
100 |
% |
Zeneca Finance (Netherlands) Company |
|
100 |
% |
MedImmune Limited |
|
100 |
% |
1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, United Kingdom |
|
|
|
MedImmune U.K. Limited |
|
100 |
% |
Plot 6, Renaissance Way, Boulevard Industry Park, Liverpool, L24 9JW, United Kingdom |
|
|
|
Syntimmune Limited |
|
100 |
% |
21 Holborn Viaduct, London, EC1A 2DY, United Kingdom |
|
|
|
Alexion Pharma UK Limited |
|
100 |
% |
Portola Pharma UK Limited (in liquidation) |
|
100 |
% |
3 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1EZ, United Kingdom |
|
|
|
|
|
|
|
United States |
|
|
|
Ardea Biosciences, Inc. |
|
100 |
% |
Amylin Ohio LLC7 |
|
100 |
% |
Amylin Pharmaceuticals, LLC7 |
|
100 |
% |
AstraZeneca Collaboration Ventures, LLC7 |
|
100 |
% |
AstraZeneca Finance LLC7 |
|
100 |
% |
AstraZeneca Finance and Holdings Inc. |
|
100 |
% |
AstraZeneca Pharmaceuticals LP8 |
|
100 |
% |
Atkemix Nine Inc. |
|
100 |
% |
Atkemix Ten Inc. |
|
100 |
% |
BMS Holdco, Inc. |
|
100 |
% |
Cincor Pharma Inc. |
|
100 |
% |
Corpus Christi Holdings Inc. |
|
100 |
% |
Isochrone Merger Sub Inc. |
|
100 |
% |
Neogene Therapeutics, Inc. |
|
100 |
% |
Omthera Pharmaceuticals, Inc. |
|
100 |
% |
Optein, Inc. |
|
100 |
% |
Stauffer Management Company LLC7 |
|
100 |
% |
Zeneca Holdings Inc. |
|
100 |
% |
Zeneca Inc. |
|
100 |
% |
Zeneca Wilmington Inc.5 |
|
100 |
% |
1800 Concord Pike, Wilmington, DE 19803, United States |
|
|
|
ZS Pharma Inc. |
|
100 |
% |
1100 Park Place, Suite 300, San Mateo, CA 94403, United States |
|
|
|
AlphaCore Pharma, LLC7 |
|
100 |
% |
333 Parkland Plaza, Suite 5, Ann Arbor, MI 48103, United States |
|
|
|
AZ-Mont Insurance Company |
|
100 |
% |
F-64
100 Bank Street, Suite 630, Burlington, VT 05401, United States |
|
|
|
MedImmune, LLC7 |
|
100 |
% |
MedImmune Ventures, Inc. |
|
100 |
% |
One MedImmune Way, Gaithersburg, MD 20878, United States |
|
|
|
Pearl Therapeutics, Inc. |
|
100 |
% |
200 Cardinal Way, Redwood City, CA 94063, United States |
|
|
|
Caelum Biosciences Inc. |
|
100 |
% |
1200 Florence Columbus Road, Bordentown, NJ 08505, United States |
|
|
|
Alexion Services Latin America Inc. |
|
100 |
% |
600 Brickell Ave, Miami, FL 33131, United States |
|
|
|
Portola USA, Inc. |
|
100 |
% |
Portola Pharmaceuticals LLC |
|
100 |
% |
270 East Grand Avenue, South San Francisco, CA 94080, United States |
|
|
|
Achillion Pharmaceuticals Inc. |
|
100 |
% |
Alexion Delaware Holding LLC |
|
100 |
% |
Alexion Pharma LLC |
|
100 |
% |
Alexion Pharmaceuticals, Inc. |
|
100 |
% |
Alexion US1 LLC |
|
100 |
% |
Alexion US Holdings LLC |
|
100 |
% |
LogicBio Therapeutics, Inc. |
|
100 |
% |
Savoy Therapeutics Corp |
|
100 |
% |
Syntimmune, Inc. |
|
100 |
% |
TeneoTwo, Inc. |
|
100 |
% |
121 Seaport Boulevard, Boston, MA 02210, United States |
|
|
|
Acerta Pharma LLC7 |
|
100 |
% |
121 Oyster Point Boulevard, South San Francisco, CA 94080, United States |
|
|
|
LogicBio Securities Corporation |
|
100 |
% |
65 Hayden Avenue, Lexington, MA 92421, United States |
|
|
|
Alexion Holding LLC |
|
100 |
% |
100 College Street, New Haven, CT 06510, United States |
|
|
|
At 31 December 2023 |
|
Group Interest |
|
Uruguay |
|
|
|
AstraZeneca S.A. |
|
100 |
% |
Yaguarón 1407 of 1205, 11.100, Montevideo, Uruguay |
|
|
|
|
|
|
|
Venezuela |
|
|
|
AstraZeneca Venezuela S.A. |
|
100 |
% |
Gotland Pharma S.A. |
|
100 |
% |
Av. La Castellana, Torre La Castellana, Piso 5, Oficina 5-G, 5-H, 5-I, Urbanización La Castellana, Municipio Chacao, Estado Bolivariano de Miranda, Venezuela |
|
|
|
|
|
|
|
Vietnam |
|
|
|
AstraZeneca Vietnam Company Limited |
|
100 |
% |
18th Floor, A&B Tower, 76 Le Lai, Ben Thanh Ward, District 1, Ho Chi Minh City, Vietnam |
|
|
|
|
|
|
|
Subsidiaries where the effective interest is less than 100% |
|
|
|
Algeria |
|
|
|
AstraZeneca Algeria Pharmaceutical Industries SPA |
|
49 |
% |
N° 20, Micro Zone d’Activité Hydra, Centre des Affaires Dar El Madina, Bloc A, 6th Floor, Hydra, Algiers, Algeria |
|
|
|
|
|
|
|
China |
|
|
|
Beijing Falikang Pharmaceutical (China) Co. Ltd |
|
49 |
% |
No. 69 Fushi Road, Haidian District, Beijing, 100143, China |
|
|
|
|
|
|
|
India |
|
|
|
AstraZeneca Pharma India Limited3 |
|
75 |
% |
Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, Bangalore-560 045, India |
|
|
|
|
|
|
|
Indonesia |
|
|
|
P.T. AstraZeneca Indonesia |
|
95 |
% |
Perkantoran Hijau Arkadia Tower F, 3rd Floor, JI. T.B. Simatupang Kav. 88, South Jakarta, 12520, Indonesia |
|
|
|
|
|
|
|
Joint Ventures |
|
|
|
China |
|
|
|
WuXi MedImmune Biopharmaceutical Co., Limited (in liquidation) |
|
50 |
% |
Room 1902, 19/F, Lee Garden One, 33 Hysan Avenue, Causeway Bay, Hong Kong |
|
|
|
IHP HK Holdings Limited |
|
50 |
% |
Unit 5805, 58/F., Two International Finance Centre 8 Finance Street, Central, China |
|
|
|
|
|
|
|
United Kingdom |
|
|
|
Centus Biotherapeutics Limited (in liquidation) |
|
50 |
% |
c/o Cork Gully LLP, 40 Villiers Street, London, WC2N 6NJ, United Kingdom |
|
|
|
|
|
|
|
Ireland |
|
|
|
Centus Biotherapeutics Europe Limited (in liquidation) |
|
50 |
% |
6th Floor, South Bank House, Barrow Street, Dublin 4, Republic of Ireland |
|
|
|
|
|
|
|
United States |
|
|
|
Montrose Chemical Corporation of California |
|
50 |
% |
Suite 380, 600 Ericksen Ave N/E, Bainbridge Island, United States |
|
|
|
|
|
|
|
Significant Holdings |
|
|
|
China |
|
|
|
Dizal (Jiangsu) Pharmaceutical Co., Ltd. |
|
26.69 |
% |
199 Liangjing Rd, Zhangjiang Hi-Tech Park, Pudong District, Shanghai, 201203, China |
|
|
|
Wuxi AstraZeneca-CICC Venture Capital Partnership (Limited Partnership) |
|
22.13 |
% |
Room 808, 8F, Building 99-2 Linghu Avenue, Xinwu District, Wuxi, Jiangsu, China |
|
|
|
|
|
|
|
United Kingdom |
|
|
|
VaxEquity |
|
40 |
% |
Lab 4 Cambridge Science Park, Unit 204 Milton Road, Cambridge, CB4 0GZ, United Kingdom |
|
|
|
|
|
|
|
United States |
|
|
|
C.C. Global Chemicals Company |
|
37.50 |
% |
PO Box 7, MS2901, Texas, TX76101-0007, United States |
|
|
|
|
|
|
|
Associated Holdings |
|
|
|
France |
|
|
|
Medetia SAS |
|
10 |
% |
Institute Imagine 24, Boulevard du Montparnasse 75015, Paris, France |
|
|
|
Cellectis S.A. |
|
22.35 |
% |
8, rue de la Croix Jarry, 75013 Paris, France |
|
|
|
|
|
|
|
Israel |
|
|
|
AION Labs Innovation Lab Ltd. |
|
19.23 |
% |
4 Oppenheimer Street, Building B, Rehovot, 7670104, Israel |
|
|
|
CombinAble.AI Ltd. |
|
11.25 |
% |
5 Oppenheimer Street, Building B, Rehovot, 7670104, Israel |
|
|
|
TenAces Biosciences Ltd. |
|
12.50 |
% |
6 Oppenheimer Street, Building B, Rehovot, 7670104, Israel |
|
|
|
|
|
|
|
Sweden |
|
|
|
Swedish Orphan Biovitrum AB (publ) |
|
9.89 |
% |
Tomtebodavägen 23A, Stockholm, Sweden |
|
|
|
OnDosis AB |
|
19.90 |
% |
GoCo House, 5 tr, Gemenskapens gata 9, 431 53 Mölndal, Sweden |
|
|
|
CCRM Nordic AB |
|
19.90 |
% |
CCRM Nordic AB, c/o GU Ventures AB, Erik Dahlbergsgatan 11 A, 411 26 Göteborg, Sweden |
|
|
|
|
|
|
|
United Kingdom |
|
|
|
Niox Group plc |
|
16.89 |
% |
Hayakawa Building, Edmund Halley Road, Oxford Science Park, Oxford, OX4 4GB, United Kingdom |
|
|
|
|
|
|
|
United States |
|
|
|
AbMed Corporation |
|
18 |
% |
68 Cummings Park Drive, Woburn, MA 01801, United States |
|
|
|
Baergic Bio, Inc. |
|
19.95 |
% |
1111 Kane Concourse, Suite 301 Bay Harbor Islands, FL 33154, United States |
|
|
|
Regio Biosciences |
|
19.54 |
% |
668 Stoney Hill Road, #2, Yardley, PA 19067, United States |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Benefit Trust |
|
|
|
The AstraZeneca Employee Benefit Trust |
|
|
|
| 1 | Ownership held in ordinary and class B special shares. |
| 2 | Ownership held in common shares, preferred shares 2003, preferred shares 2003 ex (A), preferred shares 2003 ex (B), preferred shares Series D, preferred shares Series E and preferred shares Series F. |
| 3 | Accounting year end is 31 March. |
| 4 | Accounting year end is 30 June. |
| 5 | Directly held by AstraZeneca PLC. |
| 6 | Ownership held in Ordinary A shares and Ordinary B shares. |
| 7 | Ownership held as membership interest. |
| 8 | Ownership held as partnership interest. |
| 9 | With effect from 13 January 2023, Namor Merger Sub Inc. was merged with and into Neogene Therapeutics, Inc., with Neogene Therapeutics, Inc. being the surviving corporation. |
F-65
Exhibit 2.1
DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT
As of December 31, 2023, AstraZeneca PLC (“AZ,” the “Company,” “we,” “us” and “our”) had the following series of securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading symbol(s) |
|
Name of each exchange on which registered |
American Depositary Shares, each representing one half of an Ordinary Share of 25¢ each |
|
AZN |
|
The Nasdaq Stock Market LLC |
Ordinary Shares of 25¢ each |
|
|
|
The Nasdaq Stock Market LLC * |
0.700% Notes due 2024 |
|
AZN 24 |
|
The Nasdaq Stock Market LLC |
3.375% Notes due 2025 |
|
AZN 25 |
|
The Nasdaq Stock Market LLC |
0.700% Notes due 2026 |
|
AZN 26 |
|
The Nasdaq Stock Market LLC |
1.200% Notes due 2026 |
|
AZN 26A |
|
The Nasdaq Stock Market LLC |
3.125% Notes due 2027 |
|
AZN 27A |
|
The Nasdaq Stock Market LLC |
1.750% Notes due 2028 |
|
AZN 28 |
|
The Nasdaq Stock Market LLC |
4.875% Notes due 2028 |
|
AZN 28A |
|
The Nasdaq Stock Market LLC |
4.000% Notes due 2029 |
|
AZN 29 |
|
The Nasdaq Stock Market LLC |
1.375% Notes due 2030 |
|
AZN 30 |
|
The Nasdaq Stock Market LLC |
4.900% Notes due 2030 |
|
AZN 30A |
|
The Nasdaq Stock Market LLC |
2.250% Notes due 2031 |
|
AZN 31 |
|
The Nasdaq Stock Market LLC |
4.875% Notes due 2033 |
|
AZN 33 |
|
The Nasdaq Stock Market LLC |
6.450% Notes due 2037 |
|
AZN 37 |
|
The Nasdaq Stock Market LLC |
4.000% Notes due 2042 |
|
AZN 42 |
|
The Nasdaq Stock Market LLC |
4.375% Notes due 2045 |
|
AZN 45 |
|
The Nasdaq Stock Market LLC |
4.375% Notes due 2048 |
|
AZN 48 |
|
The Nasdaq Stock Market LLC |
2.125% Notes due 2050 |
|
AZN 50 |
|
The Nasdaq Stock Market LLC |
3.000% Notes due 2051 |
|
AZN 51 |
|
The Nasdaq Stock Market LLC |
*Not for trading, but only in connection with the registration of American Depositary Shares representing such Ordinary Shares pursuant to the requirements of the Securities and Exchange Commission.
Capitalized terms used but not defined herein have the meanings given to them in AZ’s annual report on Form 20-F for the fiscal year ended December 31, 2023.
ORDINARY SHARES
The following description of our ordinary shares is a summary and does not purport to be complete. It is subject to and qualified in its entirety by AZ’s articles of association as adopted at the Annual General Meeting (“AGM”) on April 27, 2023, and by the Companies Act 2006 and any other applicable English law concerning companies, as amended from time to time.
A copy of AZ’s articles of association is filed as an exhibit to AZ’s annual report on Form 20-F for the fiscal year ended December 31, 2023, as Exhibit 1.1.
General
As at December 31, 2023 there were 1,550,162,626 ordinary shares of 25¢ each and 50,000 redeemable preference shares in issue. The ordinary shares represent 99.99% and redeemable preference shares represent 0.01% of the Company’s total share capital. Our ordinary shares are listed on the London Stock Exchange (LSE) and on the Nasdaq Stockholm. AZ ADSs (as further described below), representing 0.5 AZ ordinary shares each, are listed on the Nasdaq Stock Market LLC (Nasdaq) under the symbol “AZN”.
Under English law, persons who are neither residents nor nationals of the United Kingdom may freely hold, vote and transfer AZ’s ordinary shares in the same manner and under the same rules as UK residents or nationals.
Dividend rights
Holders of AZ’s ordinary shares may, by ordinary resolution, declare dividends but may not declare dividends in excess of the amount recommended by the board. The directors may also pay interim dividends if it appears to the board that they are justified by the profits of the Company available for distribution. Except as otherwise provided by the rights attached to shares, all dividends shall be declared and paid according to the amounts paid up on the shares on which the dividend is paid; but no amount paid on a share in advance of the date on which a call is payable shall be treated as paid on the share. Dividends may be paid in any currency or currencies and such dividends will be calculated using an appropriate market exchange rate as determined by the directors in accordance with AZ’s articles of association.
If a dividend has not been claimed, the directors may invest the dividend or use it in some other way for the benefit of AZ until the dividend is claimed. If a dividend, an amount treated as an unclaimed dividend or other amount payable in respect of a share remains unclaimed for 12 years after the date such dividend, amount treated as an unclaimed dividend or amount payable in respect of a share was declared or became due for payment, it will be forfeited and ceases to remain owing by AZ (unless the directors decide otherwise). AZ may stop sending dividend cheques, warrants or similar financial instruments by post or otherwise to a holder if those instruments have been returned undelivered to, or left uncashed by, that holder on at least two consecutive occasions, or, following one such occasion, reasonable enquiries have failed to establish the holder’s new address. This entitlement of AZ ceases if the holder claims a dividend or cashes a dividend warrant, cheque or similar financial instrument.
AZ’s articles of association permit payment or satisfaction of a dividend wholly or partly by distribution of assets, including, without limitation, paid up shares or debentures of any other body corporate. Such action must be directed by the general meeting which declared the dividend and upon the recommendation of the directors.
The redeemable preference shares carry no rights to receive dividends.
Voting rights
Shareholders holding ordinary shares directly are entitled to attend and vote at the AGM or may submit a proxy voting instruction in advance, by following the instructions in the notice of AGM. If a shareholder holds shares listed in Stockholm or holds ADRs, information relating to voting and attendance will be included in the relevant notice of AGM. If a shareholder holds his or her shares through a nominee, the nominee provider will be able to advise the shareholder of their arrangements in relation to voting and attendance. AGMs require 21 clear days’ notice to shareholders. Subject to the Companies Act 2006, other general meetings require 14 clear days’ notice.
The necessary quorum is two shareholders present in person or by proxy or corporate representative, representing at least one-third in nominal value of the issued shares of the class (excluding any shares of that class held as treasury shares) or, at any adjourned meeting of such shareholders, one shareholder present in person or by proxy or corporate representative, whatever the amount of such shareholder’s holding, who shall be deemed to constitute a meeting.
A resolution put to the vote at a general meeting held partly by means of electronic facility or facilities, unless the chair of the meeting determines that it will be decided on a show of hands, will be decided on a poll. A resolution put to the vote at a general meeting will be decided on a show of hands unless before, or on the declaration of the result of, a vote on the show of hands, or on the withdrawal of any other demand for a poll, a poll is duly demanded.
A poll may be demanded by any of the following:
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the chair of the general meeting; |
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at least five shareholders present in person or by proxy having the right to vote on the resolution; |
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any shareholder or shareholders present in person or by proxy representing not less than one-tenth of the total voting rights of all the members having the right to vote on the resolution (excluding any voting rights attached to any shares held as treasury shares); or |
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any shareholder or shareholders present in person or by proxy holding shares conferring a right to vote on the resolution, being shares on which an aggregate sum has been paid up equal to not less than one-tenth of the total sum paid up on all the shares conferring that right (excluding any shares conferring a right to vote on the resolution which are held as treasury shares). |
The holders of redeemable preference shares have no rights to receive notices of, attend or vote at general meetings except in certain limited circumstances. They have one vote for every 50,000 redeemable preference shares held.
Subject to the provisions of the Companies Act and without prejudice to any special rights previously conferred on the holders of any shares or class of shares for the time being issued, any share in the Company may be classified and be issued in any currency with such preferred, deferred or other special rights, or subject to such restrictions, whether as regards dividend, return of capital, voting or otherwise, as the Company may from time to time by ordinary resolution determine (or, in the absence of any such determination, as the board may classify and determine) and the Company may issue any shares which are, or at the option of the Company or the holder are liable to be redeemed on such terms and in such manner as may be provided by these Articles.
There are no limitations under English law or the articles on the right of non-resident or foreign owners to be the registered holders of, or to exercise voting rights in relation to, ordinary shares or ADRs or to be registered holders of notes or debentures of AZ or its wholly owned subsidiary, Zeneca Wilmington Inc.
AZ is not aware of any agreements between holders of shares that may result in restrictions on the transfer of shares or that may result in restrictions on voting rights.
Directors
AZ’s articles of association provide for a board of directors, consisting (unless otherwise determined by an ordinary resolution of shareholders) of not fewer than 5 directors and not more than 16 directors, in which all powers to manage the business of AZ are vested. Directors may be elected by the members in a general meeting or appointed by AZ’s board. All directors must retire from office at the company’s AGM each year and may present themselves for election or re-election. Directors are not prohibited, upon reaching a particular age, from submitting themselves for election or re-election. Directors may also be removed before the expiration of their term of office in accordance with the provisions of the Companies Act.
The quorum for meetings of the board is a majority of the board, of whom at least four must be non-executive directors. In the absence of a quorum, the directors do not have power to determine compensation arrangements for themselves or any member of the board.
Liquidation rights
On a distribution of AZ’s assets, on a winding-up or other return of capital (subject to certain exceptions), the holders of redeemable preference shares have priority over the holders of ordinary shares to receive the capital paid up on those shares.
Pre-emption rights and new issues of shares
Subject to the provisions of the Companies Act, and without prejudice to any rights attached to any existing shares or class of shares, shares may be issued which are to be redeemed or are to be liable to be redeemed at the option of the Company or the holder. The board may determine the terms, conditions and manner of redemption of shares provided that it does so before the shares are allotted. Subject to the provisions of the Companies Act 2006, AZ has the right to redeem the redeemable preference shares at any time on giving not less than seven days’ written notice.
Subject to the provisions of the Companies Act relating to authority, pre-emption rights or otherwise and of any resolution of the Company in general meeting passed pursuant to those provisions, and, in the case of redeemable shares, the paragraph above: (a) the board has general authority to exercise all the powers of the Company to allot shares and to grant rights to subscribe for and to convert any security into shares; (b) all shares shall be at the disposal of the board; and (c) the board may reclassify, allot (with or without conferring a right of renunciation), grant options over, or otherwise dispose of them to such persons on such terms and conditions and at such times as it thinks fit.
Disclosures of interests in AZ’s shares
There are no provisions in our articles of association whereby persons acquiring, holding or disposing of a certain percentage of AZ’s shares are required to make disclosure of their ownership percentage.
Variation of rights
If, at any time, AZ’s share capital is divided into different classes of shares, the rights attached to any class of shares may be varied, subject to the provisions of the Companies Act, either with the consent in writing of the holders of not less than three-quarters in nominal value of the issued shares of that class or with the sanction of a special resolution passed at a general meeting of such holders.
Class rights are not deemed to be varied by the creation or issue of new share ranking equally with or subsequent to that share or class of shares or by the purchase or redemption by AZ of its own shares, or AZ permitting, in accordance with the Uncertificated Securities Regulations 2001 (including any modification or re-enactment of them for the time being in force), the holding of and transfer of title to shares of that or any other class in uncertificated form by means of a relevant system.
Repurchase of shares
Having regard for business investment, funding the progressive dividend policy and meeting our debt service obligations, the AZ’s board currently believes it is appropriate to continue the suspension of the share repurchase programme which was announced in 2012.
Restrictions on transfers of shares
There are no specific restrictions on the transfer of shares in the Company, which is governed by AZ’s articles of association and prevailing legislation.
AMERICAN DEPOSITARY SHARES
General
The ordinary shares of AZ may be issued in the form of American depositary shares, or ADSs. Each ADS represents 0.5 ordinary share of AZ.
Deutsche Bank Trust Company Americas is the depositary (the “Depositary”) with respect to the ADSs, which are evidenced by American depositary receipts, or ADRs. Each ADS represents a beneficial interest in 0.5 ordinary share deposited with the custodian, as agent of the Depositary, under the Deposit Agreement dated February 6, 2020 between AZ, the Depositary and owners and beneficiaries of the ADRs (the “Deposit Agreement”).
The principal executive office of Depositary and the office at which the ADRs will be administered is currently located at 60 Wall Street, New York, NY 10005, United States of America. The Depositary is a national banking association organized under the laws of the United States. The custodian will be Deutsche Bank AG (London Branch) (the “Custodian”) and its duties will be administered from its principal London office, currently located at Winchester House, 1 Great Winchester Street, London EC2N 2DB, United Kingdom.
The holders of ADSs may hold ADSs either directly by having an ADS registered in their name on the books of the Depositary or indirectly through their broker or other financial institution (the “Holders”). If the Holders hold the ADSs through their broker or financial institution nominee, they must rely on the procedures of such broker or financial institution to assert the rights described in this section. The Holders should consult with their broker or financial institution to find out what those procedures are.
AZ will not treat the Holders as shareholders and the Holders will not have shareholder rights. The Depositary will be the holder of the ordinary shares underlying the ADSs. The Holders will have ADR holder rights, which are set out in the Deposit Agreement. The Deposit Agreement also sets out the rights and obligations of the Depositary.
The following is a summary of the material terms of the Deposit Agreement. Because it is a summary, it does not contain all the information that may be important to the Holders. For more complete information, the Holders should read the entire form of Deposit Agreement and the form of ADR, which contain the terms of the ADSs.
Please refer to Exhibit A on Form F-6 (File no. 333-258002) filed with the Securities and Exchange Commission on July 19, 2021 and available at www.sec.gov. Copies of the Deposit Agreement are also available for inspection at the offices of the Depositary.
Share Dividends and Other Distributions
Whenever the Depositary receives confirmation from the Custodian of receipt of any cash dividend or other cash distribution on any Deposited Securities, or receives proceeds from the sale of any Shares, rights securities or other entitlements under the Deposit Agreement, the Depositary will, if at the time of receipt thereof any amounts received in a Foreign Currency can, in the judgment of the Depositary (upon the terms of the Deposit Agreement), be converted on a practicable basis, into Dollars transferable to the United States, promptly convert or cause to be converted such dividend, distribution or proceeds into Dollars and will distribute promptly the amount thus received (net of applicable fees and charges of, and expenses incurred by, the Depositary and/or a division or Affiliate(s) of the Depositary and taxes and/or governmental charges) to the Holders of record as of the ADS Record Date in proportion to the number of ADSs representing such Deposited Securities held by such Holders respectively as of the ADS Record Date. The Depositary shall distribute only such amount, however, as can be distributed without attributing to any Holder a fraction of one cent. Any such fractional amounts shall be rounded down to the nearest whole cent and so distributed to Holders entitled thereto. Holders and Beneficial Owners understand that in converting Foreign Currency, amounts received on conversion are calculated at a rate which exceeds the number of decimal places used by the Depositary to report distribution rates. The excess amount may be retained by the Depositary as an additional cost of conversion, irrespective of any other fees and expenses payable or owing hereunder and shall not be subject to escheatment. If the Company, the Custodian or the Depositary is required to withhold and does withhold from any cash dividend or other cash distribution in respect of any Deposited Securities an amount on account of taxes, duties or other governmental charges, the amount distributed to Holders on the ADSs representing such Deposited Securities shall be reduced accordingly. Such withheld amounts shall be forwarded by the Company, the Custodian or the Depositary to the relevant governmental authority. Evidence of payment thereof by the Company shall be forwarded by the Company to the Depositary upon request. The Depositary shall forward to the Company or its agent such information from its records as the Company may reasonably request to enable the Company or its agent to file with governmental agencies such reports as are necessary to obtain benefits under the applicable tax treaties for the Holders and Beneficial Owners of Receipts.
If any distribution upon any Deposited Securities consists of a dividend in, or free distribution of, Shares, the Company shall cause such Shares to be deposited with the Custodian and registered, as the case may be, in the name of the Depositary, the Custodian or their nominees. Upon receipt of confirmation of such deposit, the Depositary shall, subject to and in accordance with the Deposit Agreement, establish the ADS Record Date and either (i) distribute to the Holders as of the ADS Record Date in proportion to the number of ADSs held by such Holders as of the ADS Record Date, additional ADSs, which represent in aggregate the number of Shares received as such dividend, or free distribution, subject to the terms of the Deposit Agreement (including, without limitation, the applicable fees and charges of, and expenses incurred by, the Depositary, and taxes and/or governmental charges), or (ii) if additional ADSs are not so distributed, each ADS issued and outstanding after the ADS Record Date shall, to the extent permissible by law, thenceforth also represent rights and interests in the additional Shares distributed upon the Deposited Securities represented thereby (net of the applicable fees and charges of, and the expenses incurred by, the Depositary, and taxes and/or governmental charges). In lieu of delivering fractional ADSs, the Depositary shall sell the number of Shares represented by the aggregate of such fractions and distribute the proceeds upon the terms set forth in the Deposit Agreement.
In the event that (x) the Depositary determines that any distribution in property (including Shares) is subject to any tax or other governmental charges which the Depositary is obligated to withhold, or, (y) if the Company, in the fulfillment of its obligations under the Deposit Agreement, has either (a) furnished an opinion of U.S. counsel determining that Shares must be registered under the Securities Act or other laws in order to be distributed to Holders (and no such registration statement has been declared effective), or (b) fails to timely deliver the documentation contemplated in the Deposit Agreement, the Depositary may dispose of all or a portion of such property (including Shares and rights to subscribe therefor) in such amounts and in such manner, including by public or private sale, as the Depositary deems necessary and practicable, and the Depositary shall distribute the net proceeds of any such sale (after deduction of taxes and/or governmental charges, and fees and charges of, and expenses incurred by, the Depositary and/or a division or Affiliate(s) of the Depositary) to Holders entitled thereto upon the terms of the Deposit Agreement.
The Depositary shall hold and/or distribute any unsold balance of such property in accordance with the provisions of the Deposit Agreement.
Upon timely receipt of a notice indicating that the Company wishes an elective distribution to be made available to Holders upon the terms described in the Deposit Agreement, the Depositary shall, upon provision of all documentation required under the Deposit Agreement, (including, without limitation, any legal opinions the Depositary may request under the Deposit Agreement) determine whether such distribution is lawful and reasonably practicable. If so, the Depositary shall, subject to the terms and conditions of the Deposit Agreement, establish an ADS Record Date hereof and establish procedures to enable the Holder hereof to elect to receive the proposed distribution in cash or in additional ADSs. If a Holder elects to receive the distribution in cash, the dividend shall be distributed as in the case of a distribution in cash. If the Holder hereof elects to receive the distribution in additional ADSs, the distribution shall be distributed as in the case of a distribution in Shares upon the terms described in the Deposit Agreement. If such elective distribution is not lawful or reasonably practicable or if the Depositary did not receive satisfactory documentation set forth in the Deposit Agreement, the Depositary shall, to the extent permitted by law, distribute to Holders, on the basis of the same determination as is made in the United Kingdom, in respect of the Shares for which no election is made, either (x) cash or (y) additional ADSs representing such additional Shares, in each case, upon the terms described in the Deposit Agreement. Nothing herein shall obligate the Depositary to make available to the Holder hereof a method to receive the elective dividend in Shares (rather than ADSs). There can be no assurance that the Holder hereof will be given the opportunity to receive elective distributions on the same terms and conditions as the holders of Shares.
Whenever the Company intends to distribute to the holders of the Deposited Securities rights to subscribe for additional Shares, the Company shall give notice thereof to the Depositary at least 60 days prior to the proposed distribution stating whether or not it wishes such rights to be made available to Holders of ADSs. Upon timely receipt by the Depositary of a notice indicating that the Company wishes such rights to be made available to Holders of ADSs, the Company shall determine whether it is lawful and reasonably practicable to make such rights available to the Holders. The Depositary shall make such rights available to any Holders only if the Company shall have timely requested that such rights be made available to Holders, the Depositary shall have received the documentation required by the Deposit Agreement, and the Depositary shall have determined that such distribution of rights is lawful and reasonably practicable. If such conditions are not satisfied, the Depositary shall sell the rights as described below. In the event all conditions set forth above are satisfied, the Depositary shall establish an ADS Record Date and establish procedures (x) to distribute such rights (by means of warrants or otherwise) and (y) to enable the Holders to exercise the rights (upon payment of the applicable fees and charges of, and expenses incurred by, the Depositary and/or a division or Affiliate(s) of the Depositary and taxes and/or governmental charges). Nothing herein or in the Deposit Agreement shall obligate the Depositary to make available to the Holders a method to exercise such rights to subscribe for Shares (rather than ADSs). If (i) the Company does not timely request the Depositary to make the rights available to Holders or if the Company requests that the rights not be made available to Holders, (ii) the Depositary fails to receive the documentation required by the Deposit Agreement or determines it is not lawful or reasonably practicable to make the rights available to Holders, or (iii) any rights made available are not exercised and appear to be about to lapse, the Depositary shall determine whether it is lawful and reasonably practicable to sell such rights, and if it so determines that it is lawful and reasonably practicable, endeavour to sell such rights in a riskless principal capacity or otherwise, at such place and upon such terms (including public and/or private sale) as it may deem proper. The Depositary shall, upon such sale, convert and distribute proceeds of such sale (net of applicable fees and charges of, and expenses incurred by, the Depositary and/or a division or Affiliate(s) of the Depositary and taxes and/or governmental charges) upon the terms hereof and in the Deposit Agreement. If the Depositary is unable to make any rights available to Holders or to arrange for the sale of the rights upon the terms described above, the Depositary shall allow such rights to lapse. The Depositary shall not be responsible for, and the Company shall not be liable to Holders or Beneficial Owners for (i) any failure to determine that it may be lawful or practicable to make such rights available to Holders in general or any Holders in particular, (ii) any foreign exchange exposure or loss incurred in connection with such sale, or exercise, or (iii) the content of any materials forwarded to the Holders on behalf of the Company in connection with the rights distribution.
Notwithstanding anything herein to the contrary, if registration (under the Securities Act and/or any other applicable law) of the rights or the securities to which any rights relate may be required in order for the Company to offer such rights or such securities to Holders and to sell the securities represented by such rights, the Depositary will not distribute such rights to the Holders (i) unless and until a registration statement under the Securities Act (and such other applicable law) covering such offering is in effect or (ii) unless the Company furnishes to the Depositary opinion(s) of counsel for the Company in the United States and counsel for the Company in the United Kingdom, in each case satisfactory to the Depositary, to the effect that the offering and sale of such securities to Holders and Beneficial Owners are exempt from, or do not require registration under, the provisions of the Securities Act or any other applicable laws.
In the event that the Company, the Depositary or the Custodian shall be required to withhold and does withhold from any distribution of property (including rights) an amount on account of taxes and/or other governmental charges, the amount distributed to the Holders shall be reduced accordingly. In the event that the Depositary determines that any distribution in property (including Shares and rights to subscribe therefor) is subject to any tax or other governmental charges which the Depositary is obligated to withhold, the Depositary may dispose of all or a portion of such property (including Shares and rights to subscribe therefor) in such amounts and in such manner, including by public or private sale, as the Depositary deems necessary and practicable to pay any such taxes and/or charges.
There can be no assurance that Holders generally, or any Holder in particular, will be given the opportunity to exercise rights on the same terms and conditions as the holders of Shares or to exercise such rights. Nothing herein shall obligate the Company to file any registration statement in respect of any rights or Shares or other securities to be acquired upon the exercise of such rights or otherwise to register or qualify the offer or sale of such rights or securities under the applicable law of any other jurisdiction for any purpose.
Upon receipt of a notice regarding property other than cash, Shares or rights to purchase additional Shares, to be made to Holders of ADSs, the Depositary shall determine, after consultation with the Company, whether such distribution to Holders is lawful and reasonably practicable. The Depositary shall not make such distribution unless (i) the Company shall have timely requested the Depositary to make such distribution to Holders, (ii) the Depositary shall have received the documentation required by the Deposit Agreement, and (iii) the Depositary shall have determined that such distribution is lawful and reasonably practicable. Upon satisfaction of such conditions, the Depositary shall distribute the property so received to the Holders of record as of the ADS Record Date, in proportion to the number of ADSs held by such Holders respectively and in such manner as the Depositary may deem practicable for accomplishing such distribution (i) upon receipt of payment or net of the applicable fees and charges of, and expenses incurred by, the Depositary, and (ii) net of any taxes and/or governmental charges. The Depositary may dispose of all or a portion of the property so distributed and deposited, in such amounts and in such manner (including public or private sale) as the Depositary may deem practicable or necessary to satisfy any taxes (including applicable interest and penalties) or other governmental charges applicable to the distribution.
If the conditions above are not satisfied, the Depositary shall sell or cause such property to be sold in a public or private sale, at such place or places and upon such terms as it may deem proper and shall distribute the proceeds of such sale received by the Depositary (net of (a) applicable fees and charges of, and expenses incurred by, the Depositary and/or a division or Affiliate(s) of the Depositary and (b) taxes and/or governmental charges) to the Holders upon the terms hereof and of the Deposit Agreement. If the Depositary is unable to sell such property, the Depositary may dispose of such property in any way it deems reasonably practicable under the circumstances.
Withdrawal and Cancellation
Upon surrender, at the Corporate Trust Office of the Depositary, of ADSs evidenced by this Receipt for the purpose of withdrawal of the Deposited Securities represented thereby, and upon payment of (i) the fees and charges of the Depositary for the making of withdrawals of Deposited Securities and cancellation of Receipts and (ii) all fees, taxes and/or governmental charges payable in connection with such surrender and withdrawal, and, subject to the terms and conditions of the Deposit Agreement, the Memorandum and Articles of Association and the provisions of or governing the Deposited Securities and other applicable laws, the Holder of the American Depositary Shares evidenced hereby is entitled to Delivery, to him or upon his order, of the Deposited Securities represented by the ADS so surrendered. ADS may be surrendered for the purpose of withdrawing Deposited Securities by Delivery of a Receipt evidencing such ADS (if held in registered form) or by book entry delivery of such ADS to the Depositary.
A Receipt surrendered for such purposes shall, if so required by the Depositary, be properly endorsed in blank or accompanied by proper instruments of transfer in blank, and if the Depositary so requires, the Holder thereof shall execute and deliver to the Depositary a written order directing the Depositary to cause the Deposited Securities being withdrawn to be Delivered to or upon the written order of a person or persons designated in such order.
Thereupon, the Depositary shall direct the Custodian to Deliver (without unreasonable delay) at the designated office of the Custodian or through a book-entry delivery of the Shares (in either case subject to the terms and conditions of the Deposit Agreement, to the Memorandum and Articles of Association, and to the provisions of or governing the Deposited Securities and applicable laws, now or hereafter in effect), to or upon the written order of the person or persons designated in the order delivered to the Depositary as provided above, the Deposited Securities represented by such ADSs, together with any certificate or other proper documents of or relating to title for the Deposited Securities or evidence of the electronic transfer thereof (if available) as the case may be to or for the account of such person. In the case of surrender of a Receipt evidencing a number of ADSs representing other than a whole number of Shares, the Depositary shall cause ownership of the appropriate whole number of Shares to be Delivered in accordance with the terms hereof, and shall, at the discretion of the Depositary, either (i) issue and Deliver to the person surrendering such Receipt a new Receipt evidencing American Depositary Shares representing any remaining fractional Share, or (ii) sell or cause to be sold the fractional Shares represented by the Receipt so surrendered and remit the proceeds thereof (net of (a) applicable fees and charges of, and expenses incurred by, the Depositary and/or a division or Affiliate(s) of the Depositary and (b) taxes and/or governmental charges) to the person surrendering the Receipt. At the request, risk and expense of any Holder so surrendering a Receipt, and for the account of such Holder, the Depositary shall direct the Custodian to forward (to the extent permitted by law) any cash or other property (other than securities) held in respect of, and any certificate or certificates and other proper documents of or relating to title to, the Deposited Securities represented by such Receipt to the Depositary for Delivery at the Corporate Trust Office of the Depositary, and for further Delivery to such Holder. Such direction shall be given by letter or, at the request, risk and expense of such Holder, by cable, telex or facsimile transmission. Upon receipt of such direction by the Depositary, the Depositary may make delivery to such person or persons entitled thereto at the Corporate Trust Office of the Depositary of any dividends or cash distributions with respect to the Deposited Securities represented by such Receipt, or of any proceeds of sale of any dividends, distributions or rights, which may at the time be held by the Depositary.
Voting Rights
Subject to the next sentence, as soon as practicable after receipt of notice of any meeting at which the holders of Deposited Securities are entitled to vote, or of solicitation of consents or proxies from holders of Deposited Securities, the Depositary shall fix the ADS Record Date in respect of such meeting or such solicitation of consents or proxies. The Depositary shall, if requested by the Company in writing in a timely manner (the Depositary having no obligation to take any further action if the request shall not have been received by the Depositary at least 30 Business Days prior to the date of such vote or meeting) and at the Company’s expense, and provided no U.S. legal prohibitions exist, mail by regular, ordinary mail delivery (or by electronic mail or as otherwise may be agreed between the Company and the Depositary in writing from time to time) or otherwise distribute as soon as practicable after receipt thereof to Holders as of the ADS Record Date: (a) such notice of meeting or solicitation of consent or proxy; (b) a statement that the Holders at the close of business on the ADS Record Date will be entitled, subject to any applicable law, the provisions of this Deposit Agreement, the Company’s Memorandum and Articles of Association and the provisions of or governing the Deposited Securities (which provisions, if any, shall be summarized in pertinent part by the Company), to instruct the Depositary as to the exercise of the voting rights, if any, pertaining to the Deposited Securities represented by such Holder’s American Depositary Shares; and (c) a brief statement as to the manner in which such voting instructions may be given to the Depositary. Voting instructions may be given only in respect of a number of American Depositary Shares representing an integral number of Deposited Securities. Upon the timely receipt of voting instructions of a Holder on the ADS Record Date in the manner specified by the Depositary, the Depositary shall endeavor, insofar as practicable and permitted under applicable law, the provisions of this Deposit Agreement, the Company’s Memorandum and Articles of Association and the provisions of or governing the Deposited Securities, to vote or cause the Custodian to vote the Deposited Securities (in person or by proxy) represented by American Depositary Shares evidenced by such Receipt in accordance with such voting instructions.
Neither the Depositary nor the Custodian shall, under any circumstances exercise any discretion as to voting, and neither the Depositary nor the Custodian shall vote, attempt to exercise the right to vote, or in any way make use of for purposes of establishing a quorum or otherwise, Deposited Securities represented by ADSs except pursuant to and in accordance with such written instructions from Holders. Deposited Securities represented by ADSs for which (i) no timely voting instructions are received by the Depositary from the Holder, or (ii) timely voting instructions are received by the Depositary from the Holder but such voting instructions fail to specify the manner in which the Depositary is to vote the Deposited Securities represented by such Holder’s ADSs, shall be voted in the manner provided under the previous paragraph.
There can be no assurance that Holders or Beneficial Owners generally or any Holder or Beneficial Owner in particular will receive the notice described above with sufficient time to enable the Holder to return voting instructions to the Depositary in a timely manner.
Notwithstanding the above, save for applicable provisions of the laws of England and Wales, and in accordance with the Standard of Care of the Deposit Agreement, the Depositary shall not be liable for any failure to carry out any instructions to vote any of the Deposited Securities or the manner in which such vote is cast or the effect of such vote.
Reports and Other Communications
The Company is subject to the periodic reporting requirements of the Exchange Act applicable to foreign private issuers (as defined in Rule 405 of the Securities Act) and accordingly files certain information with the Commission. These reports and documents can be inspected and copied at the public reference facilities maintained by the Commission located at 100 F Street, N.E., Washington D.C. 20549, U.S.A. The Depositary shall make available during normal business hours on any Business Day for inspection by Holders at its Corporate Trust Office any reports and communications, including any proxy soliciting materials, received from the Company which are both (a) received by the Depositary, the Custodian, or the nominee of either of them as the holder of the Deposited Securities and (b) made generally available to the holders of such Deposited Securities by the Company.
Reclassifications, Recapitalizations and Mergers
Upon any change in par value, split-up, subdivision, cancellation, consolidation or any other reclassification of Deposited Securities, or upon any recapitalization, reorganization, merger, amalgamation or consolidation or sale of assets affecting the Company or to which it otherwise is a party, any securities which shall be received by the Depositary or a Custodian in exchange for, or in conversion of or replacement or otherwise in respect of, such Deposited Securities shall, to the extent permitted by law, be treated as new Deposited Securities under the Deposit Agreement, and the Receipts shall, subject to the provisions of the Deposit Agreement and applicable law, evidence ADSs representing the right to receive such additional securities. Alternatively, the Depositary may, with the Company’s approval, and shall, if the Company shall so requests, subject to the terms of the Deposit Agreement and receipt of satisfactory documentation contemplated by the Deposit Agreement, execute and deliver additional Receipts as in the case of a stock dividend on the Shares, or call for the surrender of outstanding Receipts to be exchanged for new Receipts, in either case, as well as in the event of newly deposited Shares, with necessary modifications to this form of Receipt specifically describing such new Deposited Securities and/or corporate change. Notwithstanding the foregoing, in the event that any security so received may not be lawfully distributed to some or all Holders, the Depositary may, with the Company’s approval, and shall if the Company requests, subject to receipt of satisfactory legal documentation contemplated in the Deposit Agreement, sell such securities at public or private sale, at such place or places and upon such terms as it may deem proper and may allocate the net proceeds of such sales (net of fees and charges of, and expenses incurred by, the Depositary and/or a division or Affiliate(s) of the Depositary and taxes and/or governmental charges) for the account of the Holders otherwise entitled to such securities and distribute the net proceeds so allocated to the extent practicable as in the case of a distribution received in cash pursuant to the Deposit Agreement. The Depositary shall not be responsible for (i) any failure to determine that it may be lawful or feasible to make such securities available to Holders in general or any Holder in particular, (ii) any foreign exchange exposure or loss incurred in connection with such sale, or (iii) any liability to the purchaser of such securities.
Amendment and Termination
Subject to the terms and conditions of this paragraph, and applicable law, this Receipt and any provisions of the Deposit Agreement may at any time and from time to time be amended or supplemented by written agreement between the Company and the Depositary in any respect which they may deem necessary or desirable without the consent of the Holders or Beneficial Owners. Any amendment or supplement which shall impose or increase any fees or charges (other than the charges of the Depositary in connection with foreign exchange control regulations, and taxes and/or other governmental charges, delivery and other such expenses), or which shall otherwise materially prejudice any substantial existing right of Holders or Beneficial Owners, shall not, however, become effective as to outstanding Receipts until 30 days after notice of such amendment or supplement shall have been given to the Holders of outstanding Receipts. Notice of any amendment to the Deposit Agreement or form of Receipts shall not need to describe in detail the specific amendments effectuated thereby, and failure to describe the specific amendments in any such notice shall not render such notice invalid, provided, however, that, in each such case, the notice given to the Holders identifies a means for Holders and Beneficial Owners to retrieve or receive the text of such amendment (i.e., upon retrieval from the Commission’s, the Depositary’s or the Company’s website or upon request from the Depositary).
The parties hereto agree that any amendments or supplements which (i) are reasonably necessary (as agreed by the Company and the Depositary) in order for (a) the ADSs to be registered on Form F-6 under the Securities Act or (b) the ADSs or Shares to be traded solely in electronic book-entry form and (ii) do not in either such case impose or increase any fees or charges to be borne by Holders, shall be deemed not to materially prejudice any substantial rights of Holders or Beneficial Owners. Every Holder and Beneficial Owner at the time any amendment or supplement so becomes effective shall be deemed, by continuing to hold such ADS, to consent and agree to such amendment or supplement and to be bound by the Deposit Agreement as amended or supplemented thereby. In no event shall any amendment or supplement impair the right of the Holder to surrender such Receipt and receive therefor the Deposited Securities represented thereby, except in order to comply with mandatory provisions of applicable law. Notwithstanding the foregoing, if any governmental body should adopt new laws, rules or regulations which would require amendment or supplement of the Deposit Agreement to ensure compliance therewith, the Company and the Depositary may amend or supplement the Deposit Agreement and the Receipt at any time in accordance with such changed laws, rules or regulations. Such amendment or supplement to the Deposit Agreement in such circumstances may become effective before a notice of such amendment or supplement is given to Holders or within any other period of time as required for compliance with such laws, or rules or regulations.
The Depositary shall, at any time at the written direction of the Company, terminate the Deposit Agreement by mailing notice of such termination to the Holders of all Receipts then outstanding at least 90 days prior to the date fixed in such notice for such termination provided that, the Depositary shall be reimbursed for any amounts, fees, costs or expenses owed to it in accordance with the terms of the Deposit Agreement and in accordance with any other agreements as otherwise agreed in writing between the Company and the Depositary from time to time, prior to such termination shall take effect. If 90 days shall have expired after (i) the Depositary shall have delivered to the Company a written notice of its election to resign, or (ii) the Company shall have delivered to the Depositary a written notice of the removal of the Depositary, and in either case a successor depositary shall not have been appointed and accepted its appointment as provided herein and in the Deposit Agreement, the Depositary may terminate the Deposit Agreement by mailing notice of such termination to the Holders of all Receipts then outstanding at least 30 days prior to the date fixed for such termination. On and after the date of termination of the Deposit Agreement, each Holder will, upon surrender of such Holder’s Receipt at the Corporate Trust Office of the Depositary, upon the payment of the charges of the Depositary for the surrender of Receipts referred to in Article (2) hereof and in the Deposit Agreement and subject to the conditions and restrictions therein set forth, and upon payment of any applicable taxes and/or governmental charges, be entitled to delivery, to him or upon his order, of the amount of Deposited Securities represented by such Receipt. If any Receipts shall remain outstanding after the date of termination of the Deposit Agreement, the Registrar thereafter shall discontinue the registration of transfers of Receipts, and the Depositary shall suspend the distribution of dividends to the Holders thereof, and shall not give any further notices or perform any further acts under the Deposit Agreement, except that the Depositary shall continue to collect dividends and other distributions pertaining to Deposited Securities, shall sell rights or other property as provided in the Deposit Agreement, and shall continue to deliver Deposited Securities, subject to the conditions and restrictions set forth in the Deposit Agreement, together with any dividends or other distributions received with respect thereto and the net proceeds of the sale of any rights or other property, in exchange for Receipts surrendered to the Depositary (after deducting, or charging, as the case may be, in each case the charges of the Depositary for the surrender of a Receipt, any expenses for the account of the Holder in accordance with the terms and conditions of the Deposit Agreement and any applicable taxes and/or governmental charges or assessments). At any time after the expiration of six months from the date of termination of the Deposit Agreement, the Depositary may sell the Deposited Securities then held hereunder and may thereafter hold uninvested the net proceeds of any such sale, together with any other cash then held by it hereunder, in an unsegregated account, without liability for interest for the pro rata benefit of the Holders of Receipts whose Receipts have not theretofore been surrendered. After making such sale, the Depositary shall be discharged from all obligations under the Deposit Agreement with respect to the Receipts and the Shares, Deposited Securities and ADSs, except to account for such net proceeds and other cash (after deducting, or charging, as the case may be, in each case the charges of the Depositary for the surrender of a Receipt, any expenses for the account of the Holder in accordance with the terms and conditions of the Deposit Agreement and any applicable taxes and/or governmental charges or assessments) and except as set forth in the Deposit Agreement. Upon the termination of the Deposit Agreement, the Company shall be discharged from all obligations under the Deposit Agreement except as set forth in the Deposit Agreement.
The obligations under the terms of the Deposit Agreement and Receipts of Holders and Beneficial Owners of ADSs outstanding as of the effective date of any termination shall survive such effective date of termination and shall be discharged only when the applicable ADSs are presented by their Holders to the Depositary for cancellation under the terms of the Deposit Agreement and the Holders have each satisfied any and all of their obligations hereunder (including, but not limited to, any payment and/or reimbursement obligations which relate to prior to the effective date of termination but which payment and/or reimbursement is claimed after such effective date of termination).
Limitation on Obligations and Liability to ADR Holders
None of the Depositary, the Custodian or the Company shall be obligated to do or perform any act which is inconsistent with the provisions of the Deposit Agreement or shall incur any liability to Holders, Beneficial Owners or any third parties (i) if the Depositary, the Custodian or the Company or their respective controlling persons or agents shall be prevented or forbidden from, or subjected to any civil or criminal penalty or restraint on account of, or delayed in, doing or performing any act or thing required by the terms of the Deposit Agreement and this Receipt, by reason of any provision of any present or future law or regulation of the United States, England and Wales or any other country, or of any other governmental authority or regulatory authority or stock exchange, or by reason of any provision, present or future of the Memorandum and Articles of Association or any provision of or governing any Deposited Securities, or by reason of any act of God or war or other circumstances beyond its control, (including, without limitation, nationalization, expropriation, currency restrictions, work stoppage, strikes, civil unrest, revolutions, rebellions, explosions and computer failure), (ii) by reason of any exercise of, or failure to exercise, any discretion provided for in the Deposit Agreement or in the Memorandum and Articles of Association or provisions of or governing Deposited Securities, (iii) for any action or inaction of the Depositary, the Custodian or the Company or their respective controlling persons or agents in reliance upon the advice of or information from legal counsel, accountants, any person presenting Shares for deposit, any Holder, any Beneficial Owner or authorized representative thereof, or any other person believed by it in good faith to be competent to give such advice or information, (iv) for any inability by a Holder or Beneficial Owner to benefit from any distribution, offering, right or other benefit which is made available to holders of Deposited Securities but is not, under the terms of the Deposit Agreement, made available to Holders of ADS or (v) for any special, consequential, indirect or punitive damages for any breach of the terms of the Deposit Agreement or otherwise. The Depositary, its controlling persons, its agents (including without limitation, the Agents), any Custodian and the Company, its controlling persons and its agents may rely and shall be protected in acting upon any written notice, request, opinion or other document believed by it to be genuine and to have been signed or presented by the proper party or parties. No disclaimer of liability under the Securities Act or the Exchange Act is intended by any provision of the Deposit Agreement.
Books of Depositary
The Depositary or the Registrar, as applicable, shall keep books for the registration of Receipts and transfers of Receipts which at all reasonable times shall be open for inspection by the Company and by the Holders of such Receipts, provided that such inspection shall not be, to the Depositary’s or the Registrar’s knowledge, for the purpose of communicating with Holders of such Receipts in the interest of a business or object other than the business of the Company or other than a matter related to the Deposit Agreement or the Receipts.
The Depositary or the Registrar, as applicable, may close the transfer books with respect to the Receipts, at any time or from time to time, when deemed necessary or advisable by it in good faith in connection with the performance of its duties hereunder, or at the reasonable written request of the Company subject, in all cases, to Regulatory Compliance and compliance with U.S. Securities Laws.
DEBT SECURITIES
The following table sets for the dates of the registration statements, dates of the base prospectus, dates of issuance and issuer for each relevant series of the notes (“Notes”).
Each series of notes listed on the Nasdaq Stock Market LLC and set forth on the cover page to AZ’s annual report on Form 20-F for the fiscal year ended December 31, 2023 has either been issued by (a) AstraZeneca PLC or (b) AstraZeneca Finance LLC fully and unconditionally guaranteed on an unsecured basis by AstraZeneca PLC. Each of these series of notes was issued pursuant to an effective registration statement and a related prospectus and prospectus supplement (if applicable) setting forth the terms of the relevant series of notes. Unless otherwise stated or unless the context otherwise requires, references to the “Company”,” “we”,” “our” and “us” are to AstraZeneca PLC and its consolidated subsidiaries, references to AstraZeneca PLC are to AstraZeneca PLC exclusive of its subsidiaries, and references to AstraZeneca Finance are to AstraZeneca Finance LLC exclusive of its subsidiaries.
Each of AstraZeneca PLC and AstraZeneca Finance, exclusive of their respective subsidiaries, is referred to as a “registrant,” and together as the “registrants.” The term “issuer” means either AstraZeneca PLC or AstraZeneca Finance, exclusive of their respective subsidiaries, depending on which registrant is offering the debt securities, and the term “issuers” means both AstraZeneca PLC and AstraZeneca Finance exclusive of their respective subsidiaries. The term “Guarantor” means AstraZeneca PLC, exclusive of its subsidiaries, as guarantor of debt securities offered by AstraZeneca Finance.
The following table sets forth the dates of the registration statements, dates of the base prospectuses and dates of issuance and issuer for each relevant series of notes (the “Notes”).
Series |
|
Registration Statement |
|
Date of Base Prospectus |
|
Issuer/Date of Issuance |
|
0.700% Notes due 2024 |
|
333-256406 |
|
May 24, 2021 |
|
AstraZeneca Finance LLC/May 28, 2021 |
|
3.375% Notes due 2025 |
|
333-192551 |
|
November 26, 2013 |
|
AstraZeneca PLC/November 16, 2015 |
|
0.700% Notes due 2026 |
|
333-234586 |
|
November 8, 2019 |
|
AstraZeneca PLC/August 6, 2020 |
|
1.200% Notes due 2026 |
|
333-256406 |
|
May 24, 2021 |
|
AstraZeneca Finance LLC/May 28, 2021 |
|
3.125% Notes due 2027 |
|
333-214756 |
|
November 22, 2016 |
|
AstraZeneca PLC/June 12, 2017 |
|
1.750% Notes due 2028 |
|
333-256406 |
|
May 24, 2021 |
|
AstraZeneca Finance LLC/May 28, 2021 |
|
4.875% Notes due 2028 |
|
333-256406 |
|
May 24, 2021 |
|
AstraZeneca Finance LLC/February 28, 2023 |
|
4.000% Notes due 2029 |
|
333-214756 |
|
November 22, 2016 |
|
AstraZeneca PLC/August 17, 2018 |
|
1.375% Notes due 2030 |
|
333-234586 |
|
November 8, 2019 |
|
AstraZeneca PLC/August 6, 2020 |
|
4.900% Notes due 2030 |
|
333-256406 |
|
May 24, 2021 |
|
AstraZeneca Finance LLC/February 28, 2023 |
|
2.250% Notes due 2031 |
|
333-256406 |
|
May 24, 2021 |
|
AstraZeneca Finance LLC/May 28, 2021 |
|
4.875% Notes due 2033 |
|
333-256406 |
|
May 24, 2021 |
|
AstraZeneca Finance LLC/February 28, 2023 |
|
6.450% Notes due 2037 |
|
333-145848 |
|
August 31, 2007 |
|
AstraZeneca PLC/September 12, 2007 |
|
4.000% Notes due 2042 |
|
333-171306 |
|
December 21, 2010 |
|
AstraZeneca PLC/September 18, 2012 |
|
4.375% Notes due 2045 |
|
333-192551 |
|
November 26, 2013 |
|
AstraZeneca PLC/November 16, 2015 |
|
4.375% Notes due 2048 |
|
333-214756 |
|
November 22, 2016 |
|
AstraZeneca PLC/August 17, 2018 |
|
2.125% Notes due 2050 |
|
333-234586 |
|
November 8, 2019 |
|
AstraZeneca PLC/August 6, 2020 |
|
3.000% Notes due 2051 |
|
333-256406 |
|
May 24, 2021 |
|
AstraZeneca PLC/May 28, 2021 |
|
The following descriptions of the Notes are summaries and do not purport to be complete and are qualified in their entirety by the full terms of the applicable Notes.
The Prospectus Supplement sections below describe the specific financial and legal terms of the respective Notes, and supplements the more general descriptions under “Description of Debt Securities” in the applicable Base Prospectus of the respective Notes. To the extent that the Prospectus Supplement description is inconsistent with the terms described under “Description of Debt Securities” in the applicable Base Prospectus, the description in the Prospectus Supplement supersedes that in the applicable Base Prospectus.
A. |
0.700% Notes due 2024, 1.200% Notes due 2026, 1.750% Notes due 2028, 4.875% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes due 2031, 4.875% Notes due 2033 and 3.000% Notes due 2051 |
Prospectus Supplement:
DESCRIPTION OF ASTRAZENECA PLC NOTES
General
AstraZeneca PLC offered $750,000,000 initial aggregate principal amount of 3.000% Notes due 2051 (the “AZ PLC 2051 Notes” or the “AstraZeneca PLC Notes”), as a series of AstraZeneca PLC Notes under the indenture dated May 28, 2021 between AstraZeneca PLC, as the issuer, and The Bank of New York Mellon, as trustee (the “AstraZeneca Indenture”). The AstraZeneca PLC Notes are governed by New York law.
The AstraZeneca PLC Notes are unsecured, unsubordinated indebtedness of AstraZeneca PLC and rank equally with all of AstraZeneca PLC’s other unsecured and unsubordinated indebtedness from time to time outstanding. There is no sinking fund for any series of AstraZeneca PLC Notes. We have listed the notes on the Nasdaq Stock Market LLC.
Interest Payments and Maturity
For purposes of the description below, “business day” means any day which is not, in London, England or New York, New York, or the place of payment of amounts payable in respect of the AstraZeneca PLC Notes, a Saturday, a Sunday, a legal holiday or a day on which banking institutions are authorized or obligated by law, regulation or executive order to close. A “London business day” is a day on which dealings in deposits in U.S. dollars are transacted in the London interbank market.
Maturity. The entire principal amount of the AZ PLC 2051 Notes will mature and become due and payable, together with any accrued and unpaid interest, on May 28, 2051.
Interest Rate. The AZ PLC 2051 Notes bear interest from and including the original issue date to but excluding the date on which the principal amount is paid or made available for payment, at a rate equal to 3.000 % per annum, calculated on the basis of a 360-day year and twelve 30-day months.
Interest Payment Dates. Interest on the AZ PLC 2051 Notes is paid semi-annually in arrears on May 28 and November 28 of each year, commencing November 28, 2021. Each interest payment date referenced herein is referred to as an “Interest Payment Date.” However, if an Interest Payment Date would fall on a day that is not a business day, the Interest Payment Date will be postponed to the next succeeding day that is a business day, but no additional interest shall be paid unless we fail to make payment on such date (and such adjustment shall not affect the determination of any Interest Period).
Interest Periods. The first interest period for the AstraZeneca PLC Notes is the period from and including the issue date to but excluding the first Interest Payment Date. Thereafter, the interest periods for the AstraZeneca PLC Notes are the periods from and including the Interest Payment Dates to but excluding the immediately succeeding Interest Payment Date (together with the first interest period, each an “Interest Period”). The final Interest Period is the period from and including the Interest Payment Date immediately preceding the maturity date or the redemption date to but excluding the maturity or the redemption date.
Redemption
As explained below, under certain circumstances we may redeem the AstraZeneca PLC Notes before they mature. This means that we may repay them prior to maturity. The AstraZeneca PLC Notes will stop bearing interest on the applicable redemption date, even if you do not collect your money. We will give notice of any redemption we propose to make to DTC at least 10 days, but no more than 60 days, before the applicable redemption date. Notice by DTC to its participants and by these participants to street name holders of indirect interests in the AstraZeneca PLC Notes will be made according to arrangements among them and may be subject to statutory or regulatory requirements. Any redemption or notice may, at our discretion, be subject to one or more conditions precedent and, at our discretion, the redemption date may be delayed until such time as any or all such conditions precedent included at our discretion shall be satisfied (or waived by us) (even if more than 60 days after the giving of notice of redemption) or the redemption date may not occur and such notice may be rescinded if all such conditions precedent included at our discretion shall not have been satisfied (or waived by us).
We will notify the trustee of the redemption price of any series of AstraZeneca PLC Notes to be redeemed promptly after the calculation thereof, and the trustee shall have no responsibility for any calculation or determination in respect of the redemption price of any AstraZeneca PLC Notes, or any component thereof, and shall be entitled to receive, and fully protected in relying upon, an officers’ certificate from AstraZeneca PLC that states such redemption price.
Optional Redemption
We may redeem the AZ PLC 2051 Notes, in whole or in part, from time to time as follows: (i) prior to the Par Call Date (as set forth below), at a redemption price equal to the greater of (A) 100% of the principal amount of the AZ PLC 2051 Notes to be redeemed, and (B) as determined by the Quotation Agent, the sum of the present values of the remaining scheduled payments of principal and interest on the AZ PLC 2051 Notes to be redeemed (assuming for this purpose that the AZ PLC 2051 Notes matured on the applicable Par Call Date and not including any portion of such payments of interest accrued as of the date of redemption) discounted to the date of redemption on a semi-annual basis (assuming a 360-day year consisting of twelve 30-day months) at the Treasury Rate plus the applicable Make-Whole Spread (as set forth below) and (ii) on or after the applicable Par Call Date, at a redemption price equal to 100% of the principal amount of the AZ PLC 2051 Notes to be redeemed, plus, in each case, accrued interest thereon to but excluding the date of redemption.
In connection with such optional redemption, the following defined terms apply:
· |
Comparable Treasury Issue” means the United States Treasury security selected by the Quotation Agent as having an actual or interpolated maturity comparable to the remaining term of the applicable series of the AstraZeneca PLC Notes to be redeemed that would be utilized, at the time of selection and in accordance with customary financial practice, in pricing new issues of corporate debt securities of comparable maturity to the remaining term of such series of the AstraZeneca PLC Notes (assuming for this purpose that the AZ PLC 2051 Notes matured on the Par Call Date). |
· |
“Comparable Treasury Price” means, with respect to any redemption date, (i) the average, as determined by the Quotation Agent, of the Reference Treasury Dealer Quotations for such redemption date, after excluding the highest and lowest such Reference Treasury Dealer Quotations, or (ii) if the Quotation Agent obtains fewer than three such Reference Treasury Dealer Quotations, the average of all such quotations. |
· |
“Make-Whole Spread” means, with respect to the AZ PLC 2051 Notes, 15 basis points. |
· |
“Par Call Date” means, with respect to the AZ PLC 2051 Notes, November 28, 2050. |
· |
“Quotation Agent” means the Reference Treasury Dealer appointed by us. |
· |
“Reference Treasury Dealer” means (i) each of Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC and their respective successors or affiliates; provided, however, that if the foregoing shall cease to be a primary U.S. government securities dealer in New York City (a “primary treasury dealer”), we shall substitute therefor another primary treasury dealer; and (ii) any other primary treasury dealer selected by us. |
· |
“Reference Treasury Dealer Quotations” means, with respect to each Reference Treasury Dealer and any redemption date, the average, as determined by the Quotation Agent, of the bid and asked prices for the Comparable Treasury Issue (expressed in each case as a percentage of its principal amount) quoted in writing to the Quotation Agent by such Reference Treasury Dealer at 3:30 p.m., Eastern Time, on the third business day preceding such redemption date. |
· |
“Treasury Rate” means, with respect to any redemption date, the rate per annum equal to the semi-annual equivalent yield to maturity of the Comparable Treasury Issue, assuming a price for the Comparable Treasury Issue (expressed as a percentage of its principal amount) equal to the Comparable Treasury Price for such redemption date. |
Optional Tax Redemption
In the event of certain tax law changes and other limited circumstances relating to tax matters, we may redeem all, but not less than all, of the AstraZeneca PLC Notes of any series at a price equal to 100% of the principal amount of such series of AstraZeneca PLC Notes plus accrued interest thereon to but excluding the date of redemption.
This means we may repay any one or each series of AstraZeneca PLC Notes prior to maturity.
Further Issuances
We may, at our option, at any time and without the consent of the then existing noteholders, reopen any series of AstraZeneca PLC Notes and issue additional AstraZeneca PLC Notes in one or more transactions after the date of this prospectus supplement with terms (other than the issuance date and, possibly, first interest payment date, original interest accrual date and issue price) identical to such series of AstraZeneca PLC Notes issued hereby. These additional AstraZeneca PLC Notes will be deemed to have been part of the applicable series of AstraZeneca PLC Notes offered hereby and will provide the holders of these additional AstraZeneca PLC Notes the right to vote together with holders of the applicable series of AstraZeneca PLC Notes issued hereby; provided, however, that if these additional AstraZeneca PLC Notes are not fungible with the applicable series of AstraZeneca PLC Notes offered hereby for U.S. federal income tax purposes, these additional AstraZeneca PLC Notes will have a different CUSIP or other identifying number.
Form, Denomination, Clearance and Settlement
We will issue the AstraZeneca PLC Notes in fully registered form. The AstraZeneca PLC Notes will be represented by one or more global securities registered in the name of a nominee of DTC. You will hold beneficial interests in the Notes through DTC in book-entry form. The AstraZeneca PLC Notes will be issued in minimum denominations of $2,000 and in integral multiples of $1,000 in excess thereof. The underwriters expect to deliver the AstraZeneca PLC Notes through the facilities of DTC on May 28, 2021. Indirect holders trading their beneficial interests in the AstraZeneca PLC Notes through DTC must trade in DTC’s same-day funds settlement system and pay in immediately available funds. Secondary market trading through Euroclear and Clearstream, Luxembourg will occur in the ordinary way following the applicable rules and operating procedures of Euroclear and Clearstream, Luxembourg.
Payment of principal of and interest on AstraZeneca PLC Notes, so long as the AstraZeneca PLC Notes are represented by global securities, as discussed below, will be made in immediately available funds. Beneficial interests in the global securities will trade in the same-day funds settlement system of DTC, and secondary market trading activity in such interests will therefore settle in same-day fund.
Payment of Additional Amounts
If any deduction or withholding for any present or future taxes, levies, imposts or other governmental charges whatsoever imposed, assessed, levied or collected by or for the account of the Relevant Taxing Jurisdiction of AstraZeneca PLC or any political subdivision or taxing authority thereof or therein shall at any time be required by such jurisdiction (or any such political subdivision or taxing authority) in respect of any amounts to be paid by AstraZeneca PLC under any AstraZeneca PLC Notes, AstraZeneca PLC will (subject to compliance by the holders of such AstraZeneca PLC Notes with any administrative requirements) pay such additional amounts as may be necessary in order that the net amounts paid to the holders after such deduction or withholding, shall be not less than the amounts to which the holders were entitled had no such withholding or deduction been required; provided, however, that AstraZeneca PLC shall not be required to make any payment of additional amounts for or on account of:
(i) any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the fact that the holder (or a fiduciary, settlor, beneficiary, member or shareholder of, or possessor of a power over, such holder, if such holder is an estate, trust, partnership or corporation) is or has been a domiciliary, national or resident of, or is or has been engaged in a trade or business in, or maintains or has maintained a permanent establishment in, or is or has been physically present in, the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein or otherwise has or has had some connection with the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein other than the holding or ownership of the AstraZeneca PLC Note or the collection of principal, premium or interest, if any, on, or the enforcement of, the AstraZeneca PLC Note;
(ii) any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the fact that, where presentation is required, the relevant AstraZeneca PLC Note was presented more than 30 days after the date on which such payment became due or was provided for, whichever is later;
(iii) any estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge;
(iv) any present or future tax, levy, impost or other governmental charge which is payable otherwise than by deduction or withholding from payments on or in respect of the relevant AstraZeneca PLC Note;
(v) any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the failure of the holder or beneficial owner of the relevant AstraZeneca PLC Note to comply with any certification, identification or other reporting requirements concerning the holder’s or the beneficial owner’s nationality, residence, identity or connection with the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein, if compliance is required by treaty or by statute, regulation or administrative practice of such jurisdiction or of any such political subdivision or taxing authority thereof or therein as a condition to relief or exemption from such tax, levy, impost or other governmental charge;
(vi) any present or future tax, levy, impost or other governmental charge which the holder would have been able to avoid by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form requested by the relevant tax authority, a declaration, claim, certificate, document or other evidence establishing exemption therefrom;
(vii) any present or future tax, levy, impost or other governmental charge which is required by Sections 1471 through 1474 (“FATCA”) of the Internal Revenue Code of 1986, as amended (the “Code”), any current or future U.S. Treasury regulations or rulings promulgated thereunder, any intergovernmental agreement between the United States and any other jurisdiction to implement FATCA (an “IGA”), any law, regulation or other official guidance enacted in any jurisdiction implementing FATCA or an IGA, or any agreement with the U.S. Internal Revenue Service (the “IRS”) under or with respect to FATCA;
(viii) any present or future tax, levy, impost or other governmental charge which is imposed, assessed, levied or collected in respect of a payment under or with respect to an AstraZeneca PLC Note to any holder of the AstraZeneca PLC Note that is a fiduciary, partnership or a person other than the sole beneficial owner of such payment or AstraZeneca PLC Note to the extent that the beneficiary or settlor with respect to the fiduciary, member of that partnership or beneficial owner would not have been entitled to the additional amounts or would not have been subject to such tax, levy, impost or charge had that beneficiary, settlor, member or beneficial owner been the actual holder of such AstraZeneca PLC Note; or
(ix) any combination of the exceptions listed above (i) through (viii).
The Relevant Taxing Jurisdiction for AstraZeneca PLC is the jurisdiction in which it is resident for tax purposes (presently, the UK). AstraZeneca PLC will remit the full amount of any taxes withheld to the applicable taxing authorities in accordance with the applicable law. AstraZeneca PLC will also provide the trustee with documentation satisfactory to the trustee evidencing the payment of any taxes in respect of which AstraZeneca PLC has paid additional amounts. AstraZeneca PLC will provide copies of such documentation to the holders of the AstraZeneca PLC Notes upon request.
Any reference in this prospectus supplement, the AstraZeneca Indenture or the AstraZeneca PLC Notes to principal, premium or interest in respect of the AstraZeneca PLC Notes will be deemed also to refer to any additional amounts that may be payable with respect to such principal, premium or interest under the obligations referred to in this subsection.
Defeasance and Discharge
We may release ourselves from any payment or other obligations on each series of AstraZeneca PLC Notes as described under “Description of Debt Securities and Guarantees — Satisfaction, Discharge and Defeasance” in the Base Prospectus.
Paying Agent
The trustee, at its principal corporate trust office in The City of New York, is designated as the principal paying agent. See “— Trustee” immediately below. We may at any time designate additional paying agents or rescind the designation of paying agents or approve a change in the office through which any paying agent acts.
Trustee
The Bank of New York Mellon is the trustee under the AstraZeneca Indenture. The trustee’s current address is The Bank of New York Mellon, Corporate Trust Office, 240 Greenwich Street, New York, NY 10286. The Bank of New York Mellon will also serve as the paying agent for the AstraZeneca PLC Notes. See “— Paying Agent” immediately above.
DESCRIPTION OF ASTRAZENECA FINANCE NOTES
General
AstraZeneca Finance LLC offered $1,600,000,000 initial aggregate principal amount of 0.700% Notes due 2024 (the “AZ Finance 2024 Notes”), $1,250,000,000 initial aggregate principal amount of 1.200% Notes due 2026 (the “AZ Finance 2026 Notes”), $1,250,000,000 initial aggregate principal amount of 1.750% Notes due 2028 (the “AZ Finance 2028 Notes”), $1,100,000,000 initial aggregate principal amount of 4.875% Notes due 2028 (the “AZ Finance 2028 A Notes”), $650,000,000 initial aggregate principal amount of 4.900% Notes due 2030 (the “AZ Finance 2030 A Notes”), $750,000,000 initial aggregate principal amount of 2.250% Notes due 2031 (the “AZ Finance 2031 Notes”) and $500,000,000 initial aggregate principal amount of 4.875% Notes due 2033 (the “AZ Finance 2033 Notes” and, together with the AZ Finance 2024 Notes, the AZ Finance 2026 Notes, the AZ Finance 2028 Notes, the AZ Finance 2028 A Notes and the AZ Finance 2031 Notes, the “AstraZeneca Finance Notes”), each as a separate series of AstraZeneca Finance Notes under the indenture dated May 28, 2021 between AstraZeneca Finance LLC, as the issuer, AstraZeneca PLC, as the guarantor, and the Bank of New York Mellon, as trustee (the “AstraZeneca Finance Indenture”), and, as such, each series of AstraZeneca Finance Notes will vote and act, and may be redeemed, separately. The AstraZeneca Finance Notes are governed by New York law.
There is no sinking fund for any series of AstraZeneca Finance Notes. The AstraZeneca Finance Notes are listed on The Nasdaq Stock Market LLC.
Guarantees
The AstraZeneca Finance Notes are unsecured, unsubordinated indebtedness of AstraZeneca Finance LLC and rank equally with all of AstraZeneca Finance LLC’s other unsecured and unsubordinated indebtedness from time to time outstanding. The AstraZeneca Finance Notes are fully and unconditionally guaranteed by AstraZeneca PLC (each, a “Guaranty” and, collectively, the “Guarantees”). The Guarantees are the unsubordinated and unsecured obligations of AstraZeneca PLC and rank equally in right of payment with all of AstraZeneca PLC’s other unsecured and unsubordinated indebtedness, including debt securities issued by AstraZeneca PLC.
Interest Payments and Maturity
For purposes of the description below, “business day” means any day which is not, in London, England or New York, New York, or the place of payment of amounts payable in respect of the AstraZeneca PLC Notes, a Saturday, a Sunday, a legal holiday or a day on which banking institutions are authorized or obligated by law, regulation or executive order to close. A “London business day” is a day on which dealings in deposits in U.S. dollars are transacted in the London interbank market.
Maturity. The aggregate principal amounts of the AZ Finance 2024 Notes, the AZ Finance 2026 Notes, the AZ Finance 2028 Notes, the AZ Finance 2028 A Notes, the AZ Finance 2030 A Notes, the AZ Finance 2031 Notes and the AZ Finance 2033 Notes will mature and become due and payable, together with any accrued and unpaid interest, on May 28, 2024, May 28, 2026, May 28, 2028, March 3, 2028, March 3, 2030, May 28, 2031 and March 3, 2033, respectively.
Interest Rate. Each of the AZ Finance 2024 Notes, the AZ Finance 2026 Notes, the AZ Finance 2028 Notes, the AZ Finance 2028 A Notes, the AZ Finance 2030 A Notes, the AZ Finance 2031 Notes and the AZ Finance 2033 Notes will bear interest from and including their respective original issue dates to but excluding the respective dates on which their principal amount is paid or made available for payment, at a rate equal to 0.700%, 1.200% 1.750,%, 4.875%, 4.900%, 2.250% and 4.875% per annum, respectively, calculated on the basis of a 360-day year and twelve 30-day months.
Interest Payment Dates. Interest on the AZ Finance 2024 Notes, the AZ Finance 2026 Notes, the AZ Finance 2028 Notes and the AZ Finance 2031 Notes will be paid semi-annually in arrears on May 28 and November 28 of each year, commencing November 28, 2021. Interest on the AZ Finance 2028 A Notes, the AZ Finance 2030 A Notes and the AZ Finance 2033 Notes will be paid semi-annually in arrears on March 3 and September 3 of each year, commencing September 3, 2023. Each interest payment date referenced herein is referred to as an “Interest Payment Date.” However, if an Interest Payment Date would fall on a day that is not a business day, the Interest Payment Date will be postponed to the next succeeding day that is a business day, but no additional interest shall be paid unless we fail to make payment on such date (and such adjustment shall not affect the determination of any Interest Period).
Interest Periods. The first interest period for the AstraZeneca Finance Notes will be the period from and including the issue date to but excluding the first Interest Payment Date. Thereafter, the interest periods for the AstraZeneca Finance Notes will be the periods from and including the Interest Payment Dates to but excluding the immediately succeeding Interest Payment Date (together with the first interest period, each an “Interest Period”). The final Interest Period will be the period from and including the Interest Payment Date immediately preceding the maturity date or the redemption date to but excluding the maturity or the redemption date.
Redemption
As explained below, under certain circumstances AstraZeneca Finance may redeem the AstraZeneca Finance Notes before they mature. This means that AstraZeneca Finance may repay them prior to maturity. If AstraZeneca Finance redeems one series of AstraZeneca Finance Notes we will have no obligation to redeem any other series of AstraZeneca Finance Notes. Each series of AstraZeneca Finance Notes will stop bearing interest on the applicable redemption date, even if you do not collect your money. AstraZeneca Finance will give notice of any redemption we propose to make to DTC at least 10 days, but no more than 60 days, before the applicable redemption date. Notice by DTC to its participants and by these participants to street name holders of indirect interests in the AstraZeneca Finance Notes will be made according to arrangements among them and may be subject to statutory or regulatory requirements. Any redemption or notice may, at our discretion, be subject to one or more conditions precedent and, at our discretion, the redemption date may be delayed until such time as any or all such conditions precedent included at our discretion shall be satisfied (or waived by us) (even if more than 60 days after the giving of notice of redemption) or the redemption date may not occur and such notice may be rescinded if all such conditions precedent included at our discretion shall not have been satisfied (or waived by us).
We will notify the trustee of the redemption price of any series of AstraZeneca Finance Notes to be redeemed promptly after the calculation thereof, and the trustee shall have no responsibility for any calculation or determination in respect of the redemption price of any AstraZeneca Finance Notes, or any component thereof, and shall be entitled to receive, and fully protected in relying upon, an officers’ certificate from AstraZeneca Finance that states such redemption price.
Optional Redemption
AstraZeneca Finance may redeem the AZ Finance 2024 Notes, the AZ Finance 2026 Notes, the AZ Finance 2028 Notes and the AZ Finance 2031 Notes in whole or in part, from time to time as follows: (i) prior to the applicable Par Call Date (as set forth below), at a redemption price equal to the greater of (A) 100% of the principal amount of such AstraZeneca Finance Notes to be redeemed, and (B) as determined by the Quotation Agent, the sum of the present values of the remaining scheduled payments of principal and interest on such AstraZeneca Finance Notes to be redeemed (assuming for this purpose that such series of AstraZeneca Finance Notes matured on the applicable Par Call Date and not including any portion of such payments of interest accrued as of the date of redemption) discounted to the date of redemption on a semi-annual basis (assuming a 360-day year consisting of twelve 30-day months) at the Treasury Rate plus the applicable Make-Whole Spread (as set forth below) and (ii) on or after the applicable Par Call Date, at a redemption price equal to 100% of the principal amount of the AstraZeneca Finance Notes to be redeemed, plus, in each case, accrued interest thereon to but excluding the date of redemption.
AstraZeneca Finance may redeem the AZ Finance 2028 A Notes, the AZ Finance 2030 A Notes and the AZ Finance 2033 Notes in whole or in part, from time to time as follows: (i) prior to the applicable Par Call Date (as set forth below), at a redemption price equal to the greater of (A) 100% of the principal amount of the Notes to be redeemed, plus, in either case, accrued and unpaid interest thereon to the relevant redemption date, and (B) the sum of the present values of the remaining scheduled payments of principal and interest thereon discounted to the applicable redemption date (assuming the relevant Notes matured on the applicable Par Call Date) on a semi-annual basis (assuming a 360-day year consisting of twelve 30-day months) at the Treasury Rate (as defined herein) plus the applicable Make-Whole Spread (as set forth below) less (b) interest accrued to the relevant date of redemption and (ii) on or after the applicable Par Call Date, at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus, in each case, accrued interest thereon to but excluding the date of redemption.
In connection with such optional redemption, the following defined terms apply:
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Comparable Treasury Issue” means the United States Treasury security selected by the Quotation Agent as having an actual or interpolated maturity comparable to the remaining term of the applicable series of AstraZeneca Finance Notes to be redeemed that would be utilized, at the time of selection and in accordance with customary financial practice, in pricing new issues of corporate debt securities of comparable maturity to the remaining term of such series of AstraZeneca Finance Notes (assuming for this purpose that such series of AstraZeneca Finance Notes matured on the applicable Par Call Date). |
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“Comparable Treasury Price” means, with respect to any redemption date, (i) the average, as determined by the Quotation Agent, of the Reference Treasury Dealer Quotations for such redemption date, after excluding the highest and lowest such Reference Treasury Dealer Quotations, or (ii) if the Quotation Agent obtains fewer than three such Reference Treasury Dealer Quotations, the average of all such quotations. |
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“Make-Whole Spread” means, with respect to (i) the AZ Finance 2024 Notes, 10 basis points, (ii) the AZ Finance 2026 Notes, 10 basis points, (iii) the AZ Finance 2028 Notes, 10 basis points, (iv) the AZ Finance 2028 Notes, 15 basis points, (v) the AZ Finance 2030 Notes, 15 basis points, (vi) the AZ Finance 2031 Notes, 12.5 basis points and (vii) the AZ Finance 2033 Notes, 15 basis points. |
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“Par Call Date” means, with respect to (i) the AZ Finance 2024 Notes, May 28, 2022, (ii) the AZ Finance 2026 Notes, April 28, 2026, (iii) the AZ Finance 2028 Notes, March 28, 2028, (iv) the AZ Finance 2028 Notes, February 3, 2028, (v) the AZ Finance 2030 Notes, January 3, 2030, (vi) the AZ Finance 2031 Notes, February 28, 2031 and (vii) ) the AZ Finance 2033 Notes, December 3, 2032. |
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“Quotation Agent” means the Reference Treasury Dealer appointed by us. |
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“Reference Treasury Dealer” means (i) each of Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC and their respective successors or affiliates; provided, however, that if the foregoing shall cease to be a primary U.S. government securities dealer in New York City (a “primary treasury dealer”), we shall substitute therefor another primary treasury dealer; and (ii) any other primary treasury dealer selected by us. |
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“Reference Treasury Dealer Quotations” means, with respect to each Reference Treasury Dealer and any redemption date, the average, as determined by the Quotation Agent, of the bid and asked prices for the Comparable Treasury Issue (expressed in each case as a percentage of its principal amount) quoted in writing to the Quotation Agent by such Reference Treasury Dealer at 3:30 p.m., Eastern Time, on the third business day preceding such redemption date. |
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“Treasury Rate” means, with respect to any redemption date, the rate per annum equal to the semi-annual equivalent yield to maturity of the Comparable Treasury Issue, assuming a price for the Comparable Treasury Issue (expressed as a percentage of its principal amount) equal to the Comparable Treasury Price for such redemption date. |
Optional Tax Redemption
In the event of certain tax law changes and other limited circumstances relating to tax matters, AstraZeneca Finance may redeem all, but not less than all, of the AstraZeneca Finance Notes of any series at a price equal to 100% of the principal amount of such series of AstraZeneca Finance Notes plus accrued interest thereon to but excluding the date of redemption. This means we may repay any one or each series of AstraZeneca Finance Notes prior to maturity.
Further Issuances
AstraZeneca Finance LLC may, at its option, at any time and without the consent of the then existing noteholders, reopen any series of AstraZeneca Finance Notes and issue additional AstraZeneca Finance Notes in one or more transactions after the date of this prospectus supplement with terms (other than the issuance date and, possibly, first interest payment date, original interest accrual date and issue price) identical to such series of AstraZeneca Finance Notes issued hereby. These additional AstraZeneca Finance Notes will be deemed to have been part of the applicable series of AstraZeneca Finance Notes offered hereby and will provide the holders of these additional AstraZeneca Finance Notes the right to vote together with holders of the applicable series of AstraZeneca Finance Notes issued hereby; provided, however, that if these additional AstraZeneca Finance Notes are not fungible with the applicable series of AstraZeneca Finance Notes offered hereby for U.S. federal income tax purposes, these additional AstraZeneca Finance Notes will have a different CUSIP or other identifying number.
Form, Denomination, Clearance and Settlement
AstraZeneca Finance LLC will issue the AstraZeneca Finance Notes in fully registered form. Each series of AstraZeneca Finance Notes will be represented by one or more global securities registered in the name of a nominee of DTC. You will hold beneficial interests in the AstraZeneca Finance Notes through DTC in book-entry form. The AstraZeneca Finance Notes will be issued in minimum denominations of $2,000 and in integral multiples of $1,000 in excess thereof. The underwriters expect to deliver the AZ Finance 2024 Notes, the AZ Finance 2026 Notes, the AZ Finance 2028 Notes and the AZ Finance 2031 Notes through the facilities of DTC on May 28, 2021. The underwriters expect to deliver the AZ Finance 2028 A Notes, the AZ Finance 2030 A Notes and the AZ Finance 2033 Notes through the facilities of DTC on March 3, 2023. Indirect holders trading their beneficial interests in the AstraZeneca Finance Notes through DTC must trade in DTC’s same-day funds settlement system and pay in immediately available funds. Secondary market trading through Euroclear and Clearstream, Luxembourg will occur in the ordinary way following the applicable rules and operating procedures of Euroclear and Clearstream, Luxembourg. See “Clearance and Settlement” in the attached prospectus for more information about these clearing systems.
Payment of principal of and interest on each series of AstraZeneca Finance Notes, so long as the AstraZeneca Finance Notes are represented by global securities, as discussed below, will be made in immediately available funds. Beneficial interests in the global securities will trade in the same-day funds settlement system of DTC, and secondary market trading activity in such interests will therefore settle in same-day funds.
Payment of Additional Amounts
If any deduction or withholding for any present or future taxes, levies, imposts or other governmental charges whatsoever imposed, assessed, levied or collected by or for the account of the Relevant Taxing Jurisdiction of AstraZeneca Finance or the Guarantor (as applicable) or any political subdivision or taxing authority thereof or therein shall at any time be required by such jurisdiction (or any such political subdivision or taxing authority) in respect of any amounts to be paid by AstraZeneca Finance or the Guarantor under any AstraZeneca Finance Notes, AstraZeneca Finance or the Guarantor, as applicable, will (subject to compliance by the holders of such AstraZeneca Finance Notes with any administrative requirements) pay such additional amounts as may be necessary in order that the net amounts paid to the holders after such deduction or withholding, shall be not less than the amounts to which the holders were entitled had no such withholding or deduction been required; provided, however, that neither AstraZeneca Finance nor the Guarantor shall be required to make any payment of additional amounts for or on account of:
(i) any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the fact that the holder (or a fiduciary, settlor, beneficiary, member or shareholder of, or possessor of a power over, such holder, if such holder is an estate, trust, partnership or corporation) is or has been a domiciliary, national or resident of, or is or has been engaged in a trade or business in, or maintains or has maintained a permanent establishment in, or is or has been physically present in, the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein or otherwise has or has had some connection with the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein other than the holding or ownership of the AstraZeneca Finance Note or the collection of principal, premium or interest, if any, on, or the enforcement of, the AstraZeneca Finance Note;
(ii) any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the fact that, where presentation is required, the relevant AstraZeneca Finance Note was presented more than 30 days after the date on which such payment became due or was provided for, whichever is later;
(iii) any estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge;
(iv) any present or future tax, levy, impost or other governmental charge which is payable otherwise than by deduction or withholding from payments on or in respect of the relevant AstraZeneca Finance Note;
(v) any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the failure of the holder or beneficial owner of the relevant AstraZeneca Finance Note to comply with any certification, identification or other reporting requirements concerning the holder’s or the beneficial owner’s nationality, residence, identity or connection with the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein, if compliance is required by treaty or by statute, regulation or administrative practice of such jurisdiction or of any such political subdivision or taxing authority thereof or therein as a condition to relief or exemption from such tax, levy, impost or other governmental charge;
(vi) any present or future tax, levy, impost or other governmental charge which the holder would have been able to avoid by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form requested by the relevant tax authority, a declaration, claim, certificate, document or other evidence establishing exemption therefrom;
(vii) any present or future tax, levy, impost or other governmental charge which is required by Sections 1471 through 1474 (“FATCA”) of the Internal Revenue Code of 1986, as amended (the “Code”), any current or future U.S. Treasury regulations or rulings promulgated thereunder, any intergovernmental agreement between the United States and any other jurisdiction to implement FATCA (an “IGA”), any law, regulation or other official guidance enacted in any jurisdiction implementing FATCA or an IGA, or any agreement with the U.S. Internal Revenue Service (the “IRS”) under or with respect to FATCA;
(viii) any present or future tax, levy, impost or other governmental charge which is imposed or withheld because the holder of the AstraZeneca Finance Note is (1) considered a 10% shareholder (within the meaning of Sections 871(h)(3) or 881(c)(3) of the Code) of the issuer of the AstraZeneca Finance Note or (2) a controlled foreign corporation related (within the meaning of Section 864(d)(4) of the Code) to the issuer of the AstraZeneca Finance Note;
(ix) any present or future tax, levy, impost or other governmental charge which is imposed because the holder (1) is a bank purchasing the AstraZeneca Finance Note in the ordinary course of its lending business or (2) is a bank that is neither (A) buying the AstraZeneca Finance Note for investment purposes only nor (B) buying the AstraZeneca Finance Note for resale to a third party that either is not a bank or will hold the AstraZeneca Finance Note for investment purposes only;
(x) any present or future tax, levy, impost or other governmental charge which is imposed, assessed, levied or collected in respect of a payment under or with respect to a AstraZeneca Finance Note to any holder of the relevant AstraZeneca Finance Note that is a fiduciary, partnership or a person other than the sole beneficial owner of such payment or AstraZeneca Finance Note to the extent that the beneficiary or settlor with respect to the fiduciary, a member of that partnership or beneficial owner would not have been entitled to the additional amounts or would not have been subject to such tax, levy, impost or charge had that beneficiary, settlor, member or beneficial owner been the actual holder of such AstraZeneca Finance Note; or
(xi) any combination of the exceptions listed above (i) through (x).
The Relevant Taxing Jurisdiction for AstraZeneca Finance is the jurisdiction in which it is subject to tax by reason of its organization under such jurisdiction’s laws or, if relevant, where it is resident for tax purposes (being presently the United States) and for AstraZeneca PLC, as Guarantor, is the jurisdiction in which it is resident for tax purposes (presently, the UK).
AstraZeneca Finance and the Guarantor will remit the full amount of any taxes withheld to the applicable taxing authorities in accordance with the applicable law. AstraZeneca Finance and the Guarantor will also provide the trustee with documentation satisfactory to the trustee evidencing the payment of any taxes in respect of which AstraZeneca Finance and the Guarantor have paid additional amounts. AstraZeneca Finance and the Guarantor will provide copies of such documentation to the holders of the AstraZeneca Finance Notes upon request.
Any reference in this prospectus supplement, the AstraZeneca Finance Indenture or the AstraZeneca Finance Notes to principal, premium or interest in respect of the AstraZeneca Finance Notes will be deemed also to refer to any additional amounts that may be payable with respect to such principal, premium or interest under the obligations referred to in this subsection.
Defeasance and Discharge
AstraZeneca PLC and AstraZeneca Finance may release themselves from any payment or other obligations on each series of AstraZeneca Finance Notes as described under “Description of Debt Securities and Guarantees — Satisfaction, Discharge and Defeasance” in the Base Prospectus.
Paying Agent
The trustee, at its principal corporate trust office in The City of New York, is designated as the principal paying agent. See “— Trustee” immediately below. We may at any time designate additional paying agents or rescind the designation of paying agents or approve a change in the office through which any paying agent acts.
Trustee
The Bank of New York Mellon is the trustee under the AstraZeneca Indenture. The trustee’s current address is The Bank of New York Mellon, Corporate Trust Office, 240 Greenwich Street, New York, NY 10286. The Bank of New York Mellon will also serve as the paying agent for the AstraZeneca Finance Notes. See “— Paying Agent” immediately above.
Base Prospectus:
DESCRIPTION OF DEBT SECURITIES
The debt securities issued by AstraZeneca PLC will rank equally in right of payment with all of our other unsecured and unsubordinated indebtedness except for indebtedness that is preferred under applicable law. The debt securities issued by AstraZeneca PLC will be structurally subordinated to any indebtedness incurred by the subsidiaries of AstraZeneca PLC. as to the assets of such subsidiaries. The debt securities of AstraZeneca PLC are unsecured obligations and are not guaranteed by any of AstraZeneca PLC’s subsidiaries. The debt securities issued by AstraZeneca Finance will rank equally in right of payment with all of AstraZeneca Finance’s other unsecured and unsubordinated indebtedness except for indebtedness that is preferred under applicable law. The debt securities issued by AstraZeneca Finance will be structurally subordinated to any indebtedness incurred by the subsidiaries of AstraZeneca Finance (if any). The debt securities of AstraZeneca Finance are unsecured obligations, are guaranteed by AstraZeneca PLC, but are not guaranteed by any of AstraZeneca Finance’s subsidiaries. The debt securities of AstraZeneca Finance will be guaranteed by AstraZeneca PLC. AstraZeneca PLC’s guarantee will rank equally in right of payment with all of AstraZeneca PLC’s other unsecured and unsubordinated indebtedness, including debt securities issued by AstraZeneca PLC, except for indebtedness that is preferred under applicable law. The guarantees of AstraZeneca PLC will be structurally subordinated to any indebtedness incurred by the subsidiaries of AstraZeneca PLC as to the assets of such subsidiaries. The guarantees are unsecured obligations of AstraZeneca PLC and are not guaranteed by any of AstraZeneca PLC’s other subsidiaries.
The Trustee
The Bank of New York Mellon is the trustee under each of the indentures. As trustee, it has two main roles:
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first, it can enforce the security holder’s rights against the applicable issuer if the applicable issuer defaults on debt securities issued under each indenture. There are some limitations on the extent to which the trustee may act on the security holder’s behalf, described under “— Defaults and Related Matters — Remedies if an event of default occurs” below; and |
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second, the trustee performs administrative duties for us, such as sending the security holder interest payments and notices. |
Types of Debt Securities
Neither of the indentures limits the amount of debt securities that the applicable issuer can issue. Each of the indentures provides that debt securities may be issued in one or more series up to the aggregate principal amount as the applicable issuer authorizes from time to time. All debt securities of one series need not be issued at the same time, and the applicable issuer may reopen any series, without the consent of a holder of that series, to issue additional debt securities of the same series.
The prospectus supplement relating to a series of debt securities will describe the following terms of the series:
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whether the debt securities are issued by AstraZeneca PLC, AstraZeneca Finance LLC or both of them, and whether debt securities will benefit from one or more guarantees; |
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the title of the series of debt securities; |
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the aggregate principal amount of debt securities and any limit on the aggregate principal amount of the series of debt securities; |
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any exchange on which the debt securities will be listed; |
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the date or dates on which the applicable issuer will repay the principal amount of the series of debt securities or the method by which the date or dates will be determined; |
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any rate or rates at which the series of debt securities will bear interest or the method by which the interest rate or rates will be determined; |
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the date or dates from which any interest on the series of debt securities will accrue, the dates on which interest will be payable and the record dates for interest payments and the method by which interest will be calculated if different to a 360-day year of twelve 30-day months; |
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the place or places where the principal and any interest on debt securities will be payable if other than the corporate trust office of the trustee in New York, New York; |
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the price or prices at which, the period or periods within which, and the terms and conditions upon which the applicable issuer may redeem the series of debt securities in whole or in part; |
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any right or obligation to redeem, repay or purchase the debt securities as a result of any sinking fund or similar provisions, or at the option of the holder of the debt securities and the period or periods within which, the price or prices at which and every other term and condition upon which the debt securities will be redeemed, repaid or purchased; |
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the denominations in which debt securities of the series are issuable, if other than denominations of $2,000 and any whole multiple of $1,000 in excess thereof; |
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the portion of the principal amount of the series of debt securities payable if an acceleration of the maturity of the debt securities is declared or provable in bankruptcy, if other than the principal amount; |
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the currency, including any composite currency, of payment of the principal, premium, if any, and interest on the series of debt securities if other than U.S. dollars; |
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whether the applicable issuer or a holder of debt securities may elect to have the principal, premium, if any, or interest on the series of debt securities paid in a currency or composite currency other than the currency in which the debt securities are stated to be payable, and if so, any election period and the terms and conditions governing such an election; |
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whether the applicable issuer will be required to pay additional amounts for withholding taxes or other governmental charges and, if applicable, a related right to an optional tax redemption for such a series; |
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any index used to determine the amount of payment of principal, premium, if any, and interest on the series of debt securities and how these amounts will be determined if they are not fixed when the debt securities are issued; |
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the forms of the series of debt securities; |
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the applicability of the provisions described later under “— Satisfaction, Discharge and Defeasance”; |
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any authenticating or paying agents, transfer agents or registrars or any other agents acting in connection with the debt securities other than the trustee; |
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if applicable, a discussion of any additional or alternative material U.S. federal income and UK tax considerations; and |
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any other special features of the series of debt securities. |
We may issue the debt securities as original issue discount securities, which are debt securities offered and sold at a substantial discount to their stated principal amount.
Guaranty
Unless otherwise provided in the prospectus supplement relating to debt securities of any series of AstraZeneca Finance, each series of AstraZeneca Finance’s debt securities shall be fully and unconditionally guaranteed by the Guarantor as to (i) the prompt payment by AstraZeneca Finance of the outstanding principal of such debt securities when and as the same shall become due, whether at the stated maturity thereof, by acceleration or otherwise, (ii) the prompt payment by AstraZeneca Finance of any interest and any premium payable with respect to the outstanding principal of all such debt securities when and as the same shall become due, whether at the stated maturity thereof, by acceleration or otherwise and (iii) the payment of all other sums owing from AstraZeneca Finance under such debt securities when and as the same shall become due, all in accordance with the terms of such debt securities and the AstraZeneca Finance indenture (the payment obligations by AstraZeneca PLC identified in subparagraphs (i) through (iii) being collectively referred to herein as the “Guaranteed Obligations”). All payments by the Guarantor shall be made in lawful money of the United States of America. Each Guaranty shall be unsecured and unsubordinated indebtedness of the Guarantor and rank equally with other unsecured and unsubordinated indebtedness for borrowed money of the Guarantor.
Each Guaranty shall terminate and be of no further force and effect (i) subject to customary contingent reinstatement provisions, upon payment in full of the aggregate principal amount of all applicable debt securities then outstanding and all other Guaranteed Obligations of the Guarantor then due and owing or (ii) upon legal or covenant defeasance of AstraZeneca Finance’s obligations in accordance with the terms of the AstraZeneca Finance indenture or the full satisfaction and discharge of the AstraZeneca Finance indenture with respect to all series of debt securities issued thereunder; provided that all Guaranteed Obligations incurred to the date of such satisfaction and discharge have been paid in full.
Under the AstraZeneca Finance indenture, the Guarantor is generally permitted to consolidate or merge with another person that is organized under the laws of the UK, a State of the U.S. or any other country which is a member of the Organization for Economic Cooperation and Development. The Guarantor is also generally permitted to sell or convey its property as an entirety or substantially as an entirety to such other entity.
Its ability to take some of these actions is restricted in the following ways:
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any successor to the Guarantor must assume the Guarantor’s obligations in relation to the Guarantees and under the AstraZeneca Finance indenture; and |
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if the succeeding entity is resident for tax purposes other than in the UK, the succeeding entity’s assumption of the Guarantor’s obligations in relation to the Guarantees and under the AstraZeneca Finance indenture must include the obligation to pay any additional amounts as described under “— Payment of Additional Amounts.” |
Each Guaranty shall provide that in the event of a default in the payment of principal of and any interest and any premium which may be payable by AstraZeneca Finance in respect of the debt securities issued by AstraZeneca Finance, the holder of such debt securities may institute legal proceedings directly against the Guarantor to enforce the Guaranty without proceeding first against AstraZeneca Finance.
Overview of the Remainder of this Description
The remainder of this description summarizes:
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Additional mechanics relevant to the debt securities under normal circumstances, such as how the security holder transfers ownership and where the applicable issuer makes payments. |
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The security holder’s right to receive payment of additional amounts due to changes in the tax withholding requirements of various jurisdictions. |
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The security holder’s rights under several special situations, such as if the applicable issuer merges with another company or if the applicable issuer wants to redeem the debt securities for tax reasons. |
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Covenants contained in the applicable indenture that restrict AstraZeneca PLC’s ability to incur liens and undertake sale and leaseback transactions. A particular series of debt securities may have different covenants. |
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The security holder’s rights if there is a default under the applicable indenture. |
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The security holder’s rights if the applicable issuer wants to modify the indenture. |
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The relationship of the issuers with the trustee. |
Additional Mechanics
Exchange and Transfer
The debt securities will be issued only in fully registered form without interest coupons in denominations of $2,000 or whole multiples of $1,000 in excess thereof. The security holder may have his or her debt securities broken into more debt securities of smaller denominations of whole multiples of $1,000 (but not less than a minimum denomination of $2,000) or combined into fewer debt securities of larger denominations of whole multiples of $1,000, as long as the total principal amount is not changed. This is called an exchange.
The security holder may exchange or transfer registered debt securities at the office of the trustee. The trustee acts as the agent for the issuers for registering debt securities in the names of holders and for transferring registered debt securities. Each issuer may change this appointment to another entity or perform the service by itself. The entity performing the role of maintaining the list of registered holders is called the security registrar. It will also register transfers of the registered debt securities.
The security holder may not exchange his or her registered debt securities for bearer securities.
There will be no service charge for any exchange or registration of transfer of the debt securities, but the applicable issuer may require payment of an amount sufficient to cover any tax or other governmental charge imposed in connection with any exchange or registration of transfer.
The transfer or exchange of a registered debt security may be made only if the security registrar is satisfied with the security holder’s proof of ownership.
If the debt securities are redeemable and the applicable issuer redeems less than all of the debt securities of a particular series, such issuer may block the transfer or exchange of debt securities during a specified period of time in order to freeze the list of holders to prepare the mailing. The period begins 15 days before the day the applicable issuer first mails the notice of redemption and ends on the day of that mailing. The applicable issuer may also refuse to register transfers or exchanges of debt securities selected or called for redemption. However, the applicable issuer will continue to permit transfers and exchanges of the unredeemed portion of any security being partially redeemed.
Payment and Paying Agents
The applicable issuer will pay interest to the security holder if he or she is a direct holder of debt securities at the close of business on a particular day in advance of each due date for interest, even if the security holder no longer owns the security on the interest due date. That particular day, usually about two weeks in advance of the interest due date, is called the record date and is stated in the applicable prospectus supplement.
Unless provided otherwise in the applicable prospectus supplement, the applicable issuer will pay interest, principal and any other money due on debt securities in registered form at the corporate trust office of The Bank of New York Mellon in the Borough of Manhattan, The City and State of New York as paying agent for the debt securities. That office is located at The Bank of New York Mellon, 101 Barclay Street, New York, New York 10286. At its option, the applicable issuer may pay interest on any debt securities by check mailed to the registered holders.
Some of the debt securities may be denominated, and payments may be made, in currencies other than U.S. dollars or in composite currencies. A summary of any special considerations which apply to these debt securities is in the applicable prospectus supplement.
Street name and other indirect holders should consult their banks or brokers for information on how they will receive payments.
The applicable issuer may arrange for additional payment offices, or may cancel or change these offices, including the use of the trustee’s corporate trust office. These offices are called paying agents. The applicable issuer may also choose to act as its own paying agent, but must always maintain a paying agency in the Borough of Manhattan, The City and State of New York. Whenever there are changes in the paying agents for any particular series of debt securities the applicable issuer must notify the trustee.
Payment of Additional Amounts
Payment of Additional Amounts by AstraZeneca PLC
Unless provided otherwise in the applicable prospectus supplement, if any deduction or withholding for any present or future taxes, levies, imposts or other governmental charges whatsoever imposed, assessed, levied or collected by or for the account of the Relevant Taxing Jurisdiction of AstraZeneca PLC or any political subdivision or taxing authority thereof or therein shall at any time be required by such jurisdiction (or any such political subdivision or taxing authority) in respect of any amounts to be paid by AstraZeneca PLC under any series of AstraZeneca PLC debt securities, AstraZeneca PLC will (subject to compliance by holders of such AstraZeneca PLC debt securities with any administrative requirements) pay such additional amounts as may be necessary in order that the net amounts paid to the holders after such deduction or withholding, shall be not less than the amounts to which the holders are entitled had no such withholding or deduction been required; provided, however, that AstraZeneca PLC shall not be required to make any payment of additional amounts for or on account of:
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any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the fact that the holder (or a fiduciary, settlor, beneficiary, member or shareholder of, or possessor of a power over, such holder, if such holder is an estate, trust, partnership or corporation) is or has been a domiciliary, national or resident of, or is or has been engaged in a trade or business in, or maintains or has maintained a permanent establishment in, or |
is or has been physically present in, the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein or otherwise has or has had some connection with the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein other than the holding or ownership of the debt security or the collection of principal, premium or interest, if any, on, or the enforcement of, the debt security;
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any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the fact that, where presentation is required, the relevant debt security was presented more than 30 days after the date on which such payment became due or was provided for, whichever is later; |
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any estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge; |
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any present or future tax, levy, impost or other governmental charge which is payable otherwise than by deduction or withholding from payments on or in respect of the relevant debt security; |
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any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the failure of the holder or beneficial owner of the relevant debt security to comply with any certification, identification or other reporting requirements concerning the holder’s or the beneficial owner’s nationality, residence, identity or connection with the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein, if compliance is required by treaty or by statute, regulation or administrative practice of such jurisdiction or of any such political subdivision or taxing authority thereof or therein as a condition to relief or exemption from such tax, levy, impost or other governmental charge; |
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any present or future tax, levy, impost or other governmental charge which the holder would have been able to avoid by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form requested by the relevant tax authority, a declaration, claim, certificate, document or other evidence establishing exemption therefrom; |
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any present or future tax, levy, impost or other governmental charge which is required by Sections 1471 through 1474 (“FATCA”) of the Internal Revenue Code of 1986, as amended (the “Code”), any current or future U.S. Treasury regulations or rulings promulgated thereunder, any intergovernmental agreement between the United States and any other jurisdiction to implement FATCA (an “IGA”), any law, regulation or other official guidance enacted in any jurisdiction implementing FATCA or an IGA, or any agreement with the U.S. Internal Revenue Service (the “IRS”) under or with respect to FATCA; |
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any present or future tax, levy, impost or other governmental charge which is imposed, assessed, levied or collected in respect of a payment under or with respect to a debt security to any holder of the relevant debt security that is a fiduciary, partnership or a person other than the sole beneficial owner of such payment or debt security to the extent that the beneficiary or settlor with respect to the fiduciary, member of that partnership or beneficial owner would not have been entitled to the additional amounts or would not have been subject to such tax, levy, impost or charge had that beneficiary, settlor, member or beneficial owner been the actual holder of such debt security; or |
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any combination of the exceptions listed above. |
Payment of Additional Amounts by AstraZeneca Finance and the Guarantor
Unless provided otherwise in the applicable prospectus supplement, if any deduction or withholding for any present or future taxes, levies, imposts or other governmental charges whatsoever imposed, assessed, levied or collected by or for the account of the Relevant Taxing Jurisdiction of AstraZeneca Finance or the Guarantor (as applicable) or any political subdivision or taxing authority thereof or therein shall at any time be required by such jurisdiction (or any such political subdivision or taxing authority) in respect of any amounts to be paid by AstraZeneca Finance or the Guarantor under any series of AstraZeneca Finance debt securities, AstraZeneca Finance or the Guarantor, as applicable, will (subject to compliance by the holders of such AstraZeneca Finance debt securities with any administrative requirements) pay such additional amounts as may be necessary in order that the net amounts paid to the holders after such deduction or withholding, shall be not less than the amounts to which the holders are entitled had no such withholding or deduction been required; provided, however, that neither AstraZeneca Finance nor the Guarantor shall be required to make any payment of additional amounts for or on account of:
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any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the fact that the holder (or a fiduciary, settlor, beneficiary, member or shareholder of, or possessor of a power over, such holder, if such holder is an estate, trust, partnership or corporation) is or has been a domiciliary, national or resident of, or is or has been engaged in a trade or business in, or maintains or has maintained a permanent establishment in, or is or has been physically present in, the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein or otherwise has or has had some connection with the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein other than the holding or ownership of the debt security or the collection of principal, premium or interest, if any, on, or the enforcement of, the debt security; |
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any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the fact that, where presentation is required, the relevant debt security was presented more than 30 days after the date on which such payment became due or was provided for, whichever is later; |
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any estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge; |
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any present or future tax, levy, impost or other governmental charge which is payable otherwise than by deduction or withholding from payments on or in respect of the relevant debt security; |
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any present or future tax, levy, impost or other governmental charge which would not have been so imposed, assessed, levied or collected but for the failure of the holder or beneficial owner of the relevant debt security to comply with any certification, identification or other reporting requirements concerning the holder’s or the beneficial owner’s nationality, residence, identity or connection with the Relevant Taxing Jurisdiction or any political subdivision or taxing authority thereof or therein, if compliance is required by treaty or by statute, regulation or administrative practice of such jurisdiction or of any such political subdivision or taxing authority thereof or therein as a condition to relief or exemption from such tax, levy, impost or other governmental charge; |
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any present or future tax, levy, impost or other governmental charge which the holder would have been able to avoid by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form requested by the relevant tax authority, a declaration, claim, certificate, document or other evidence establishing exemption therefrom; |
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any present or future tax, levy, impost or other governmental charge which is required by Sections 1471 through 1474 (“FATCA”) of the Internal Revenue Code of 1986, as amended (the “Code”), any current or future U.S. Treasury regulations or rulings promulgated thereunder, any intergovernmental agreement between the United States and any other jurisdiction to implement FATCA (an “IGA”), any law, regulation or other official guidance enacted in any jurisdiction implementing FATCA or an IGA, or any agreement with the IRS under or with respect to FATCA; |
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any present or future tax, levy, impost or other governmental charge which is imposed or withheld because the holder of the debt security is (1) considered a 10% shareholder (within the meaning of Sections 871(h)(3) or 881(c)(3) of the Code) of the issuer of the debt security or (2) a controlled foreign corporation related (within the meaning of Section 864(d)(4) of the Code) to the issuer of the debt security; |
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any present or future tax, levy, impost or other governmental charge which is imposed because the holder (1) is a bank purchasing the debt security in the ordinary course of its lending business or (2) is a bank that is neither (A) buying the debt security for investment purposes only nor (B) buying the debt security for resale to a third party that either is not a bank or will hold the debt security for investment purposes only; |
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any present or future tax, levy, impost or other governmental charge which is imposed, assessed, levied or collected in respect of a payment under or with respect to a debt security to any holder of the relevant debt security that is a fiduciary, partnership or a person other than the sole beneficial owner of such payment or debt security to the extent that the beneficiary or settlor with respect to the fiduciary, member of that partnership or beneficial owner would not have been entitled to the additional amounts or would not have been subject to such tax, levy, impost or charge had that beneficiary, settlor, member or beneficial owner been the actual holder of such debt security; or |
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any combination of the exceptions listed above. |
The Relevant Taxing Jurisdiction for AstraZeneca PLC, as issuer or Guarantor, is the jurisdiction in which it is resident for tax purposes (presently, the UK) and for AstraZeneca Finance is the United States.
In respect of payments by either AstraZeneca PLC or AstraZeneca Finance, no additional amounts shall be paid in the event that the obligation to pay additional amounts is the result of the issuance of definitive registered securities to a holder of predecessor securities at such holder’s request upon the occurrence of an event of default and at the time payment is made definitive registered securities have not been issued in exchange for the entire principal amount of the predecessor securities.
At least 5 business days prior to each date on which any payment under or with respect to the debt securities of any series is due and payable (unless such obligation to pay additional amounts arises after the 5th business day prior to the date on which payment under or with respect to the debt securities of such series is due and payable, in which case it will be promptly thereafter), if an issuer or the Guarantor (with respect to a series of AstraZeneca Finance debt securities) will be obligated to pay additional amounts with respect to such payment, the applicable issuer or the Guarantor (with respect to such series of AstraZeneca Finance debt securities), as the case may be, will deliver to the trustee an officers’ certificate stating that such additional amounts will be payable and the amounts so payable and setting forth such other information as is necessary to enable the trustee to pay such additional amounts to the holders of the debt securities of such series on the payment date.
Mergers and Similar Events
AstraZeneca PLC
AstraZeneca PLC is generally permitted to consolidate or merge with another company or other entity that is organized under the laws of the UK, a state of the U.S. or any other country which is a member of the Organization for Economic Cooperation and Development. AstraZeneca PLC is also generally permitted to sell or convey its property as an entirety or substantially as an entirety to such other entity. AstraZeneca PLC’s ability to take some of these actions is restricted in the following ways:
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any entity succeeding us must assume our obligations in relation to the debt securities and the guarantees under the indenture; and |
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if the succeeding entity is resident for tax purposes other than in the UK, the succeeding entity’s assumption of our obligations in relation to the debt securities and guarantees under the applicable indenture must include the obligation to pay any additional amounts as described under “— Payment of Additional Amounts”. |
It is possible that the merger, sale, or lease of all or substantially all of our assets would cause a principal property of ours or of a restricted subsidiary of ours or shares of stock or indebtedness of any of our restricted subsidiaries to become subject to a lien giving other lenders preferential rights in that property over holders of debt securities. We have promised to limit these preferential rights on our property, called liens, as discussed under “— Limitation on Liens”. If a merger or other transaction would create any impermissible liens on our property, we must grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
AstraZeneca Finance LLC
AstraZeneca Finance is generally permitted to consolidate or merge with another person that is organized under the laws of the UK, any State of the U.S. or any other country which is a member of the Organization for Economic Cooperation and Development.
AstraZeneca Finance’s ability to take some of these actions is restricted in the following ways:
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any entity succeeding AstraZeneca Finance must assume AstraZeneca Finance’s obligations in relation to the debt securities and under the AstraZeneca Finance indenture; |
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the Guarantor, unless it is the other party to the transactions described above, shall have by supplemental indenture confirmed that the Guaranty shall apply to AstraZeneca Finance’s successor’s obligations under AstraZeneca Finance’s debt securities and the AstraZeneca Finance indenture; and |
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if the succeeding entity is resident for tax purposes elsewhere than the U.S., the succeeding entity’s assumption of AstraZeneca Finance’s obligations in relation to the debt securities under the applicable indenture must include the obligation to pay any additional amounts as described under “— Payment of Additional Amounts.” |
AstraZeneca Finance is also generally permitted to sell or convey its property as an entirety or substantially as an entirety to another person, and these actions are not limited under the AstraZeneca Finance indenture
Optional Tax Redemption
Unless provided otherwise in the applicable prospectus supplement, the applicable issuer has the option to redeem the debt securities in the situations described below. The redemption price for the debt securities, other than debt securities issued with original issue discount, will be equal to the principal amount of the debt securities being redeemed plus accrued interest and any additional amounts due on the date fixed for redemption. The redemption price for debt securities issued with original issue discount will be specified in the applicable prospectus supplement. The applicable issuer must give you between 10 and 60 days’ notice before redeeming the debt securities.
The first situation is where, as a result of a change or amendment to any law or related regulation or ruling of the Relevant Taxing Jurisdiction of the applicable issuer or the Guarantor or any political subdivision or taxing authority thereof or therein, or any change in an application or interpretation of such laws, regulations or rulings, or any change in application or interpretation of, or any execution of or amendment to, any treaty or treaties affecting taxation to which such jurisdiction or a political subdivision thereof is party, (i) the applicable issuer or the Guarantor would have to pay additional amounts as described under “— Payment of Additional Amounts” or (ii) a subsidiary of the applicable issuer or the Guarantor would be required to deduct or withhold tax on any payment to the issuer or the Guarantor to enable the issuer or the Guarantor to make any payment of principal or interest in respect of the debt securities, and in either case this cannot be avoided by the use of reasonable measures available.
This first situation applies only in the case of changes, amendments, applications, interpretations or executions that become effective on or after the date specified in the prospectus supplement for the applicable series of debt securities. If the applicable issuer or the Guarantor is succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which the applicable issuer or the Guarantor is resident for tax purposes, and the applicable date will be the date such entity became the successor to the applicable issuer or the Guarantor, rather than the date specified in the preceding sentence.
The second situation is where, as a result of action taken by a taxation authority of, or any action brought in a court of competent jurisdiction in, the Relevant Taxing Jurisdiction of the applicable issuer or the Guarantor or any political subdivision or taxing authority thereof or therein, which action is taken or brought on or after the date specified in the prospectus supplement for the applicable series of debt securities, (i) the applicable issuer or the Guarantor would have to pay additional amounts as described under “— Payment of Additional Amounts” or (ii) a subsidiary of the applicable issuer or the Guarantor would be required to deduct or withhold tax on any payment to the issuer or the Guarantor to enable the issuer or the Guarantor to make any payment of principal or interest in respect of the debt securities, and in either case this cannot be avoided by the use of reasonable measures available. This second situation applies only in the case of actions taken on or after the date specified in the prospectus supplement for the applicable series of debt securities. If the applicable issuer or the Guarantor is succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which the applicable issuer or the Guarantor is resident for tax purposes, and the applicable date will be the date such entity became the successor to the applicable issuer or the Guarantor, rather than the date specified in the preceding sentence.
The third situation is where, as a result of any delivery or requirement to deliver definitive, registered securities (having used all reasonable efforts to avoid having to issue such definitive registered securities), (i) the applicable issuer or the Guarantor would have to pay additional amounts as described under “—Payment of Additional Amounts” or (ii) a subsidiary of the applicable issuer or the Guarantor would be required to deduct or withhold tax on any payment to the issuer or the Guarantor to enable the issuer or the Guarantor to make any payment of principal or interest in respect of the debt securities, and in either case this cannot be avoided by the use of reasonable measures available.
The fourth situation is where, if the person formed by a consolidation of the applicable issuer or Guarantor or into which the applicable issuer or Guarantor is merged or to which the applicable issuer or the Guarantor conveys, transfers or leases its properties and assets substantially as an entirety is required to pay a holder additional amounts in respect of any tax, assessment or governmental charge which is imposed on any such holder or required to be withheld or deducted from any payment to such holder as a consequence of such consolidation, merger, conveyance, transfer or lease.
Covenants
Limitation on Liens
Some of the property of AstraZeneca PLC and its subsidiaries may be subject to a mortgage, pledge, assignment, charge or other legal mechanism that gives a lender preferential rights in that property over other lenders, including the security holders and the other direct holders of the debt securities, or over the general creditors of AstraZeneca PLC and its subsidiaries, if such lender is not repaid. These preferential rights are generally called liens.
AstraZeneca PLC undertakes that it and certain of its subsidiaries, which we refer to as “restricted subsidiaries,” will not become obligated on any new debt for borrowed money that is secured by a lien on any principal property or on any shares of stock or indebtedness of any of its restricted subsidiaries unless AstraZeneca PLC grants an equivalent or higher-ranking lien on the same property to you and the other direct holders of the debt securities.
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Restricted subsidiary means any wholly-owned subsidiary of AstraZeneca PLC: |
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with substantially all of its property located within the UK or the U.S.; and |
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which owns a principal property, but does not include any wholly-owned subsidiary principally engaged in leasing or in financing installment receivables or principally engaged in financing the operations of us and our consolidated subsidiaries. |
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A wholly-owned subsidiary means any corporation in which control, directly or indirectly, of all of the stock with ordinary voting power to elect the board of directors of that corporation is owned by AstraZeneca PLC, or by one or more of its wholly-owned subsidiaries or by AstraZeneca PLC and one or more of its wholly-owned subsidiaries. |
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A subsidiary, with respect to any person, is any corporation in which that person owns or controls directly or indirectly at least a majority of stock with ordinary voting power to elect a majority of the board of directors. |
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Principal property means any manufacturing plant or facility or any research facility owned by AstraZeneca PLC or any restricted subsidiary. A principal property must also be located within the UK or the U.S. and have a gross book value (before deducting any depreciation reserve) exceeding 2% of AstraZeneca PLC’s consolidated net tangible assets. Principal property does not include: |
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any plant or facility or research facility which in the opinion of our board of directors is not materially important to the total business conducted by us and our subsidiaries; or |
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any portion of a property described above which, in the opinion of our board of directors, is not materially important to the use or operation of the property. |
AstraZeneca PLC does not need to comply with this restriction if the amount of all debt that would be secured by liens on its principal properties and the shares of stock or indebtedness of its restricted subsidiaries is no more than 15% of its consolidated net tangible assets.
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Our consolidated net tangible assets mean AstraZeneca PLC’s consolidated total assets, after deducting: |
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all liabilities due within one year (other than short-term borrowings and long-term debt due within one year); and |
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all goodwill, trade names, trademarks, patents and other similar types of intangible assets as shown on the audited consolidated balance sheet contained in the latest annual report to our shareholders. |
This restriction on liens does not apply to debt secured by a number of different types of liens. These types of liens include the following:
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any lien on property, shares of stock or indebtedness of any corporation existing at the time the corporation becomes a restricted subsidiary; |
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any lien on property or shares of stock existing at the time of acquisition of that property or those shares of stock, or to secure the payment of all or any part of the purchase price of that property or those shares of stock, or to secure any debt incurred before, at the time of, or within twelve months after, in the case of shares of stock, the acquisition of the shares of stock and, in the case of property, the later of the acquisition, completion of construction (including any improvements on an existing property) or commencement of the commercial operation of the property, where the debt is incurred to finance all or any part of the purchase price; |
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any lien securing debt owed to AstraZeneca PLC or to any of its restricted subsidiaries by AstraZeneca PLC or any of its restricted subsidiaries; |
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any lien existing as of the date of the applicable indenture; |
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any lien on a principal property to secure debt incurred to finance all or part of the cost of improving, constructing, altering or repairing any building, equipment or facilities or of any other improvements on all or any part of that principal property, if the debt is incurred before, during, or within twelve months after completing the improvement, construction, alteration or repair; |
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any lien on property owned or held by any corporation or on shares of stock or indebtedness of any corporation, where the lien existed either at the time the corporation is merged, consolidated or amalgamated with either AstraZeneca PLC or a restricted subsidiary or at the time of a sale, lease or other disposition of all or substantially all of the property of a corporation to AstraZeneca PLC or a restricted subsidiary; |
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any lien arising by operation of law and not securing amounts more than 90 days overdue or otherwise being contested in good faith; |
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any lien arising by operation of law over any credit balance or cash held in any account with a financial institution; |
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any rights of financial institutions to offset credit balances in connection with the operation of cash management programs established for the benefit of AstraZeneca PLC and/or for the benefit of any restricted subsidiary; |
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any lien incurred or deposits made in the ordinary course of business, including but not limited to: |
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any mechanics’, materialmen’s, carriers’, workmen’s, vendors’ or other similar liens; |
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any liens securing amounts in connection with workers’ compensation, unemployment insurance and other types of social security; and |
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any easements, rights-of-way, restrictions and other similar charges; |
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any liens incurred or deposits made securing the performance of tenders, bids, leases, statutory obligations, surety and appeal bonds, government contracts, performance and return of money bonds and other obligations of a similar nature incurred in the ordinary course of business; |
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any lien securing taxes or assessments or other applicable governmental charges or levies; |
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any extension, renewal or replacement or successive extensions, renewals or replacements, in whole or in part, of any lien included in the preceding paragraphs or of any of the debt secured under the preceding paragraphs, so long as the principal amount of debt secured does not exceed the principal amount of debt secured at the time of the extension, renewal or replacement, and that the extension, renewal or replacement lien is limited to all or any part of the same property or shares of stock that secured the lien extended, renewed or replaced (including improvements on that property), or property received or shares of stock issued in substitution or exchange; and |
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any lien in favor of AstraZeneca PLC or any of its subsidiaries. |
The following types of transactions will not be deemed to create debt secured by a lien and, therefore, will also not be subject to the restriction on liens:
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any liens on property of AstraZeneca PLC or a restricted subsidiary in favor of the U.S. or any State of the U.S., or the UK, or any other country, or any political subdivision of, or any department, agency or instrumentality of, these countries or states, to secure partial, progress, advance or other payments under provisions of any contract or statute including, but not limited to, liens to secure debt of pollution control or industrial revenue bond type, or to secure any indebtedness incurred for the purpose of financing all or any part of the purchase price or cost of construction of the property subject to these liens. |
Limitation on Sale and Lease-Back Transactions
Neither AstraZeneca PLC nor any of its restricted subsidiaries will enter into any sale and lease-back transaction involving a principal property without complying with this covenant.
A sale and lease-back transaction is an arrangement between AstraZeneca PLC or a restricted subsidiary and any person in which AstraZeneca PLC or the restricted subsidiary leases back for a term of more than three years a principal property that AstraZeneca PLC or the restricted subsidiary has sold or transferred to that person.
AstraZeneca PLC and its restricted subsidiaries may enter into sale and lease-back transactions provided that the total amount of attributable debt attributable to all sale and lease-back transactions plus other debt of AstraZeneca PLC or any of its restricted subsidiaries that is secured by liens (but excluding debt secured by liens on property that AstraZeneca PLC or a restricted subsidiary would be entitled to incur, assume or guarantee without equally and ratably securing the debt securities offered by this prospectus as described under “— Limitation on Liens” above) does not exceed 15% of consolidated net tangible assets.
This restriction does not apply to any sale and lease-back transaction if:
· |
AstraZeneca PLC or the restricted subsidiary seeking to enter into the sale and lease-back could incur, assume or guarantee debt secured by a lien on the principal property to be leased without equally and ratably securing the debt securities offered by this prospectus as a result of one or more of the exceptions to the limitation on liens as described under “— Limitation on Liens” above; |
· |
within twelve months before or after the sale or transfer, regardless of whether the sale or transfer may have been made by AstraZeneca PLC or a restricted subsidiary, we apply, an amount equal to the net proceeds of the sale or transfer (in the case of a sale or transfer for cash), or an amount equal to the fair |
value of the principal property so leased at the time of entering into the sale or transfer as determined by our board of directors (in the case of a sale or transfer otherwise than for cash), to:
o |
the retirement of indebtedness for money borrowed, incurred or assumed by AstraZeneca PLC or any restricted subsidiary which matures at, or is extendible or renewable at the option of the obligor to, a date more than twelve months after the date of incurring, assuming or guaranteeing such debt, or |
o |
investment in any principal property or principal properties. |
This restriction on sale and lease-back transactions also does not apply to any transaction between AstraZeneca PLC and a restricted subsidiary, or between restricted subsidiaries.
Attributable debt means the present value (discounted at a rate equal to the weighted average of the rate of interest on all securities then issued and outstanding under the indenture, compounded semi-annually) of AstraZeneca PLC’s or a restricted subsidiary’s obligation for rental payments for the remaining term of any lease in a sale and lease-back transaction.
Default and Related Matters
Events of Default
A holder of debt securities of a particular series will have special rights if any event of default occurs with respect to that series and is not cured, as described later in this subsection.
What is an event of default? An event of default means any of the following:
· |
Interest — default for 30 days in the payment of any installment of interest on the series of debt securities; |
· |
Principal — default in the payment of all or any part of the principal of the series of debt securities when such principal becomes due and payable either at maturity, upon redemption, by acceleration or otherwise; |
· |
Sinking Fund Installment — default in the payment of any sinking fund installment as and when such installment becomes due and payable by the specific terms of the series of debt securities or beyond any period of grace; |
· |
Covenant — breach or default by the applicable issuer or the Guarantor in the performance of a covenant or warranty in respect of the debt securities of the relevant series which has not been remedied for ninety days after the applicable issuer receives written notice of the default from the trustee or the applicable issuer and the trustee receive written notice of the default from the holders of at least 25% of the principal amount of the debt securities of all affected series; |
· |
Bankruptcy — certain events of bankruptcy, insolvency or reorganization affecting (i) with respect to debt securities issued by AstraZeneca PLC, AstraZeneca PLC or (ii) with respect to debt securities issued by AstraZeneca Finance, AstraZeneca PLC or AstraZeneca Finance; or |
· |
Other — any other event of default provided in any supplemental indenture or resolution of our board of directors under which a particular series is issued or in the form of security for such series. |
No event of default described in the provisions above with respect to a particular series of debt securities will necessarily constitute an event of default with respect to any other series of debt securities and the events of default for any specific series may be modified as described in the applicable prospectus supplement.
Remedies if an event of default occurs. If an event of default, other than a “Bankruptcy” default, has occurred (but only if, in the case of a “Covenant” default, the default has occurred for less than all series of debt securities then issued under the applicable indenture and outstanding) and has not been cured, the trustee or the holders of at least 25% of the principal amount of debt securities of the affected series (each affected series voting as a separate class) may declare the principal amount (or, if the debt securities of a series are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all the debt securities of that series, together with any accrued interest, to be due and payable immediately.
If an event of default has occurred under “Covenant” default with respect to all of the series of debt securities then issued under the applicable indenture and outstanding, or under “Bankruptcy” default, and has not been cured, the trustee or the holders of at least 25% of the principal amount of all the debt securities then issued under the applicable indenture and outstanding (treated as one class) may declare the principal (or, if any debt securities are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all debt securities then issued under the applicable indenture and outstanding, together with any accrued interest, to be due and payable immediately. This is called a declaration of acceleration of maturity. A declaration of acceleration of maturity may be canceled by the holders of at least a majority in principal amount of the debt securities of the affected series or by at least a majority in principal amount of all the debt securities then issued under the applicable indenture and outstanding (voting as one class), as the case may be, if certain conditions are met.
Before a declaration of acceleration of maturity, past “Covenant” defaults that do not affect all series of debt securities then issued under the applicable indenture and outstanding may be waived by the holders of a majority in principal amount of the debt securities then outstanding of each affected series (each such series voting as a separate class). Past “Covenant” defaults that affect all series of debt securities then issued under the applicable indenture and outstanding and past “Bankruptcy” defaults may be waived by the holders of a majority in principal amount of all the debt securities then issued under the applicable indenture and outstanding (treated as one class). Default in the payment of principal of or interest on or any sinking fund installment of debt securities of any series or a covenant or provision of the applicable indenture that cannot be modified or amended without the consent of the holder of each debt security affected may only be modified or amended with the consent of such holder.
Except in cases of default, where the trustee has some special duties, the trustee is not required to take any action under the applicable indenture at the request of any holders unless the holders offer the trustee reasonable protection from expenses and liability. This protection is called an indemnity. If reasonable indemnity is provided, the holders of a majority in principal amount of the outstanding debt securities of the relevant series may, subject to certain limitations and conditions, direct the time, method and place of conducting any lawsuit or other formal legal action seeking any remedy available to the trustee. These majority holders may also, subject to certain limitations and conditions, direct the trustee in performing any other action under the applicable indenture.
Before the security holder bypasses the trustee and brings his or her own lawsuit or other formal legal action or takes other steps to enforce his or her rights or protects his or her interests relating to the debt securities of an applicable series, the following must occur:
· |
the security holder must give the trustee written notice that an event of default with respect to an applicable series has occurred and remains uncured; |
· |
the holders of 25% in principal amount of all outstanding debt securities of the relevant series must make a written request that the trustee take action because of the default, and must offer reasonable indemnity to the trustee against the cost and other liabilities of taking that action; and |
· |
the trustee must have not taken action for 60 days after receipt of the above notice and offer of indemnity and the trustee has not received an inconsistent direction from the holders of a majority in principal amount of all outstanding debt securities of the relevant series during that period. |
These limitations do not apply to a suit instituted by the security holder for the enforcement of payment of the principal or interest on a debt security of a particular series on or after the respective due dates.
With respect to debt securities issued by AstraZeneca PLC, the issuer will file annually with the trustee on or before March 31 in each year a written statement of certain of its officers certifying that, to their knowledge, the issuer has not defaulted on its covenants under the applicable indenture or else specifying any default that exists. With respect to debt securities issued by AstraZeneca Finance LLC, the issuer and the Guarantor will file annually with the trustee on or before March 31 in each year a written statement of certain of their officers certifying that, to their knowledge, the issuer and the Guarantor have not defaulted on their covenants under the applicable indenture or else specifying any default that exists.
For any series of debt securities that is a series of original issue discount securities the applicable prospectus supplement will contain provisions for the acceleration of the maturity of a portion of the principal amount of such original issue discount securities.
Modification of the Indentures and Waiver
There are three types of changes which the applicable issuer can make to the applicable indenture and any series of debt securities under the applicable indenture.
Changes not requiring approval. The first type of change does not require any vote by holders of debt securities. The security holder’s consent is not required to do any of the following:
· |
to transfer or pledge any property or assets to the trustee as security for any series of the debt securities; |
· |
to evidence the succession of any successor corporation to the applicable issuer or the Guarantor as described under “Mergers and Similar Events” above; |
· |
to evidence the succession of any successor trustee under the applicable indenture or to add to or change any provisions of the applicable indenture as necessary to provide for the appointment of an additional trustee or trustees; |
· |
to add to the covenants or to add additional events of default for the benefit of the holders of any series of the applicable debt securities; |
· |
to cure any ambiguity or to correct or supplement any provision of the applicable indenture that may be defective or inconsistent with any other provision of such indenture; or |
· |
to make any other provisions with respect to matters or questions arising under the applicable indenture as the board of directors of the applicable issuer or AstraZeneca PLC, as guarantor, may deem necessary or desirable and that shall not adversely affect the interests of holders of any applicable series of the debt securities in any material respect. |
Changes requiring the approval of a majority of holders. The second type of change to either indenture and the debt securities requires a vote in favor by holders of debt securities owning at least a majority of the principal amount of all series of debt securities then outstanding and affected by such charge (each affected series voting as a separate class). In this manner, any provision of the applicable indenture or any series of debt securities may be changed or eliminated unless the provision relates to a matter that requires the consent of each affected holder as discussed below.
Changes requiring the security holder’s approval. Third, there are changes that cannot be made to the security holder’s debt securities without the specific approval of each affected holder. The security holder’s consent is required before we could do any of the following:
· |
extend the final maturity of a debt security; |
· |
reduce the principal amount of a debt security; |
· |
reduce the rate or extend the time of payment of any interest on a debt security; |
· |
reduce any amount payable on redemption of a debt security; |
· |
reduce the amount of principal due and payable upon an acceleration of the maturity or provable in bankruptcy of a debt security issued at an original issue discount; |
· |
impair your right to sue for payment; |
· |
impair any right of repayment at the option of the holder; |
· |
reduce the percentage of holders of debt securities whose consent is needed to modify or amend an indenture; |
· |
change in any manner adverse to the holders of the debt securities our obligations relating to the payment of principal and interest, and sinking fund payments; or |
· |
with respect to the debt securities issued by AstraZeneca Finance LLC, change, in any manner adverse to the interest of holders of the debt securities, the terms and provisions of the guarantees in respect of the due and punctual payment of principal of and interest on the debt securities. |
Satisfaction, Discharge and Defeasance
The applicable issuer may terminate its repayment and obligations on a particular series of the debt securities, when:
· |
such issuer has paid or caused to be paid the principal of and interest, if any, then due and payable on all outstanding debt securities of any series; or |
· |
such issuer has delivered to the trustee for cancellation all outstanding debt securities of any series; or |
· |
all the outstanding debt securities of the series that have not been delivered to the trustee for cancellation have become or will become due and payable within one year and the applicable issuer has made arrangements satisfactory to the trustee for the giving of notice of redemption by the trustee in the name of the issuer; and |
· |
the applicable issuer has deposited with the trustee sufficient funds to pay and discharge the entire indebtedness on the series of debt securities to pay principal and interest, if any, and paid all other sums payable under the applicable indenture. |
The applicable issuer may legally release itself from any payment or other obligations on the debt securities of a particular series, except for various obligations described below, if such issuer, in addition to other actions, puts in place the following arrangements for you:
· |
the applicable issuer must deposit in trust for your benefit and the benefit of all other direct holders of the debt securities of the series a combination of money and government obligations that will generate enough cash to make interest, principal and any other payments on the debt securities on their various due dates; and |
· |
the applicable issuer must deliver to the trustee either a legal opinion of its counsel to the effect that the holders of the debt securities of that series will not recognize gain or loss for U.S. federal income tax purposes as a result of the defeasance and will be subject to the same U.S. federal income tax as would be the case if the defeasance did not occur or a ruling to that effect received from or published by the IRS. |
However, even if the applicable issuer takes these actions, a number of obligations relating to the debt securities will remain. These include the following obligations:
· |
to register the transfer and exchange of debt securities and the right of optional redemption, if any; |
· |
to replace mutilated, defaced, destroyed, lost or stolen debt securities; |
· |
to pay principal and interest, if any, on the original stated due dates and any remaining rights of the holders to receive sinking fund payments, if any, from funds deposited with the trustee; |
· |
immunities of the trustee; and |
· |
to hold money for payment in trust. |
Government obligation means securities that are:
· |
direct obligations of the U.S. or any foreign government of a sovereign state for the payment of which is pledged by the full faith and credit of the U.S. or such foreign government; or |
· |
obligations of an entity controlled or supervised by and acting as an agency or instrumentality of the U.S. or any foreign government of a sovereign state the payment of which is unconditionally guaranteed as a full faith and credit obligation of the U.S. or such foreign government, |
and are not callable or redeemable at the option of the applicable issuer.
Government obligation also includes:
· |
a depositary receipt issued by a bank or trust company as custodian for these government obligations, or specific payment of interest on or principal of these government obligations, held by such custodian for the account of the holder of a depositary receipt, provided that (except as required by law) such custodian is not authorized to make any deductions from the amount payable to the holder of such depositary receipt from any amount received by the custodian in respect of these government obligations, or the specific payment of interest on or principal of these government obligations, evidenced by such depositary receipt. |
Notices
Each applicable issuer and the trustee will send notices only to direct holders, using their addresses registered in the trustee’s records.
Regardless of who acts as paying agent, all money that the applicable issuer pays to a paying agent that remains unclaimed at the end of two years after the amount is due to direct holders of debt securities will be repaid to the applicable issuer. After that two-year period, the security holder may look only to the applicable issuer for payment and not to the trustee, any other paying agent or anyone else.
Governing Law
The debt securities, the guarantees and each of the indenture will be governed by and construed in accordance with the laws of the State of New York.
Concerning the Trustee
The Bank of New York Mellon acts as the trustee with respect to certain debt securities of certain of our subsidiaries.
If an event of default occurs, or an event occurs that would be an event of default if the requirements for either giving the applicable issuer notice or the applicable issuer’s default having to exist for a specified time period were disregarded, the trustee may be considered to have a conflicting interest with respect to the debt securities of a series or the applicable indenture for purposes of the Trust Indenture Act of 1939. In that case, the trustee may be required to resign as trustee under the applicable indenture and we would be required to appoint a successor trustee.
B. |
4.000% Notes due 2029 and 4.375% Notes due 2048 |
Prospectus Supplement:
DESCRIPTION OF NOTES
General
We offered $1,000,000,000 initial aggregate principal amount of 4.000% Notes due 2029 (the “2029 Notes”) and $750,000,000 initial aggregate principal amount of 4.375% Notes due 2048 (the “2048 Notes”, and together with the 2029 Notes, the “Fixed Rate Notes” or the “Notes”), each as a separate series of Notes under the Indenture, and, as such, each series of Notes vote and act, and may be redeemed, separately.
The Notes are governed by New York law.
The Notes are unsecured, unsubordinated indebtedness of AstraZeneca PLC and rank equally with all of AstraZeneca PLC’s other unsecured and unsubordinated indebtedness from time to time outstanding.
There is no sinking fund for any series of Notes. We have listed the Notes on the Nasdaq Stock Market LLC.
Interest Payments and Maturity
For purposes of the description below, “business day” means any day which is not, in London, England or New York, New York, or the place of payment of amounts payable in respect of the Notes, a Saturday, a Sunday, a legal holiday or a day on which banking institutions are authorized or obligated by law, regulation or executive order to close. A “London business day” is a day on which dealings in deposits in U.S. dollars are transacted in the London interbank market.
Maturity. The entire principal amount of the 2029 Notes and the 2048 Notes will mature and become due and payable, together with any accrued and unpaid interest, on January 17, 2029 and August 17, 2048, respectively.
Interest Rate. Each of the 2029 Notes and the 2048 Notes will bear interest from August 17, 2018 until their principal amount is paid or made available for payment, at a rate equal to 4.000% and 4.375% per annum, respectively, calculated on the basis of a 360-day year and twelve 30-day months.
Interest Payment Dates. Interest on the 2029 Notes will be paid semi-annually in arrears on January 17 and July 17 of each year, commencing January 17, 2019 (each, a “2029 Fixed Rate Interest Payment Date”). Interest on the 2048 Notes will be paid semi-annually in arrears on February 17 and August 17 of each year, commencing February 17, 2019 (each, a “2048 Fixed Rate Interest Payment Date”, and together with each 2029 Fixed Rate Interest Payment Date, each a “Fixed Rate Interest Payment Date”). However, if a Fixed Rate Interest Payment Date would fall on a day that is not a business day, the Fixed Rate Interest Payment Date will be postponed to the next succeeding day that is a business day, but no additional interest shall be paid unless we fail to make payment on such date.
Interest Periods. The first interest period for the Fixed Rate Notes will be the period from and including the issue date to but excluding the first Fixed Rate Interest Payment Date. Thereafter, the interest periods for the Fixed Rate Notes will be the periods from and including the Fixed Rate Interest Payment Dates to but excluding the immediately succeeding Fixed Rate Interest Payment Date (together with the first interest period, each a “Fixed Rate Interest Period”). The final Fixed Rate Interest Period will be the period from and including the Fixed Rate Interest Payment Date immediately preceding the maturity date to the maturity or the redemption date.
Redemption
As explained below, under certain circumstances we may redeem the Notes before they mature. This means that we may repay them early. If we redeem one series of Notes we will have no obligation to redeem any other series. The security holder has no right to require us to redeem the Notes. Notes will stop bearing interest on the redemption date, even if the security holder does not collect his or her money. We will give notice to DTC of any redemption we propose to make at least 15 days, but no more than 30 days, before the redemption date. Notice by DTC to participating institutions and by these participants to street name holders of indirect interests in the Notes will be made according to arrangements among them and may be subject to statutory or regulatory requirements. Subject to the optional tax redemption described below, we may not redeem the Floating Rate Notes prior to maturity.
Optional Redemption
We may redeem the Fixed Rate Notes of each series, in whole or in part, from time to time as follows: (i) prior to the Par Call Date (as set forth below), at a redemption price equal to the greater of (A) 100% of the principal amount of the Fixed Rate Notes to be redeemed, and (B) as determined by the Quotation Agent, the sum of the present values of the remaining scheduled payments of principal and interest on the Fixed Rate Notes to be redeemed (assuming for this purpose that such series of Fixed Rate Notes matured on the applicable Par Call Date and not including any portion of such payments of interest accrued as of the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the treasury rate plus the Make-Whole Spread (as set forth below) and (ii) on or after the Par Call Date, at a redemption price equal to 100% of the principal amount of the Fixed Rate Notes to be redeemed, plus, in each case, accrued interest thereon to but excluding the date of redemption.
In connection with such optional redemption, the following defined terms apply:
· |
“Comparable treasury issue” means the United States Treasury security selected by the Quotation Agent as having a maturity comparable to the remaining term of the applicable series of Fixed Rate Notes to be redeemed that would be utilized, at the time of selection and in accordance with customary financial practice, in pricing new issues of corporate debt securities of comparable maturity to the remaining term of such series of Fixed Rate Notes (assuming for this purpose that such series of Fixed Rate Notes matured on the applicable Par Call Date). |
· |
“Comparable treasury price” means, with respect to any redemption date, (i) the average, as determined by the Quotation Agent, of the reference treasury dealer quotations for such redemption date, after excluding the highest and lowest such reference treasury dealer quotations, or (ii) if the Quotation Agent obtains fewer than three such reference treasury dealer quotations, the average of all such quotations. |
· |
“Make-Whole Spread” means, with respect to (i) the 2029 Notes, 20 basis points and (ii) the 2048 Notes, 25 basis points. |
· |
“Par Call Date” means, with respect to (i) the the 2029 Notes, October 17, 2028 and (ii) the 2048 Notes, February 17, 2048. |
· |
“Quotation Agent” means the reference treasury dealer appointed by us. |
· |
“Reference treasury dealer” means (i) each of Citigroup Global Markets Inc., Deutsche Bank Securities Inc., Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC and their respective successors or affiliates; provided, however, that if the foregoing shall cease to be a primary US government securities dealer in New York City (a “primary treasury dealer”), we shall substitute therefor another primary treasury dealer; and (ii) any other primary treasury dealer selected by us. |
· |
“Reference treasury dealer quotations” means, with respect to each reference treasury dealer and any redemption date, the average, as determined by the Quotation Agent, of the bid and asked prices for the comparable treasury issue (expressed in each case as a percentage of its principal amount) quoted in writing to the trustee by such reference treasury dealer at 5:00 p.m., Eastern Standard Time, on the third business day preceding such redemption date. |
· |
“Treasury rate” means, with respect to any redemption date, the rate per annum equal to the semiannual equivalent yield to maturity of the comparable treasury issue, assuming a price for the comparable treasury issue (expressed as a percentage of its principal amount) equal to the comparable treasury price for such redemption date. |
Optional Tax Redemption
In the event of various tax law changes after the date of this prospectus supplement and other limited circumstances that require us to pay additional amounts, as described below under “— Payment of Additional Amounts”, we may redeem all, but not less than all, of each series of Notes at a price equal to 100% of the principal amount of each series of Notes plus accrued interest thereon to but excluding the date of redemption. This means we may repay any one or each series of Notes early. We discuss our ability to redeem the Notes in greater detail under “Description of Debt Securities — Optional Tax Redemption” in the accompanying prospectus.
Further Issuances
We may, without the consent of the holders of any series of Notes, issue additional Notes of each or any such series having the same ranking and same interest rate, maturity date, redemption terms and other terms as the applicable series of Notes described in this prospectus supplement. Any such additional Notes, together with the applicable series of Notes offered by this prospectus supplement, will constitute a single series of securities under the Indenture. There is no limitation on the amount of Notes or other debt securities that we may issue under such Indenture.
Form, Denomination, Clearance and Settlement
We will issue the Notes in fully registered form. Each series of Notes will be represented by one or more global securities registered in the name of a nominee of DTC. The security holder will hold beneficial interests in the Notes through DTC in book-entry form. The Notes will be issued in minimum denominations of $2,000 and in integral multiples of $1,000 in excess thereof. The underwriters expect to deliver the Notes through the facilities of DTC on August 17, 2018. Indirect holders trading their beneficial interests in the Notes through DTC must trade in DTC’s same-day funds settlement system and pay in immediately available funds. Secondary market trading through Euroclear and Clearstream, Luxembourg will occur in the ordinary way following the applicable rules and operating procedures of Euroclear and Clearstream, Luxembourg.
Payment of principal of and interest on each series of Notes, so long as the Notes are represented by global securities, as discussed below, will be made in immediately available funds. Beneficial interests in the global securities will trade in the same-day funds settlement system of DTC, and secondary market trading activity in such interests will therefore settle in same-day funds.
Payment of Additional Amounts
We agree that any amounts to be paid by us under the Notes of principal, premium and interest in respect of the Notes will be paid without deduction or withholding for, any and all present and future taxes, levies, duties, assessments, imposts or other governmental charges of whatever nature imposed, assessed, levied or collected by or for the account of the government of any jurisdiction in which we are resident for tax purposes (at the time of the issuance, the UK) or any political subdivision or taxing authority of such jurisdiction, unless such withholding or deduction is required by law. If such deduction or withholding is at any time required, we will (subject to compliance by the security holder with any relevant administrative requirements) pay such additional amounts as will result in the receipt of such amounts as would have been received by the holder had no such withholding or deduction been required, provided that we will not have to pay additional amounts if:
(i) the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for the holder’s (or certain related parties’) connection to the jurisdiction in which we are resident for tax purposes, other than by merely holding the Note or by receiving principal, premium, if any, or interest, if any, on the Note, or enforcing the Note. These connections include where the holder or related party:
· |
is or has been a domiciliary, national or resident of such jurisdiction; |
· |
is or has been engaged in a trade or business in such jurisdiction; |
· |
has or had a permanent establishment in such jurisdiction; or |
· |
is or has been physically present in such jurisdiction; |
(ii) the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for presentation of the Note for payment, if presentation is required, more than 30 days after the Note became due or payment was provided for;
(iii) the tax, levy, impost or other governmental charge is an estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge;
(iv) the tax, levy, impost or other governmental charge is payable in a manner that does not involve deduction or withholding from payments on or in respect of the relevant Note;
(v) the tax, levy, impost or other governmental charge would not have been imposed or withheld but for the failure of the holder or beneficial owner, upon a reasonable request, addressed to the holder, to comply with any certification, identification or other reporting requirement under a reasonable request, addressed to the holder, concerning the holder’s or the beneficial owner’s nationality, residence, identity or connection with any jurisdiction in which we are resident for tax purposes, if compliance is required by any treaty, statute, regulation or administrative practice of such jurisdiction as a condition to relief or exemption from such tax, levy, impost or other governmental charge;
(vi) the tax, levy, impost or other governmental charge is required by Sections 1471 through 1474 of the Internal Revenue Code of 1986, as amended (“FATCA”), any current or future U.S. Treasury Regulations or rulings promulgated thereunder, any intergovernmental agreement between the United States and any other jurisdiction to implement FATCA (an “IGA”), any law, regulation or other official guidance enacted in any jurisdiction implementing FATCA or an IGA, or any agreement with the U.S. Internal Revenue Service under or with respect to FATCA; or
(vii) any combination of the taxes referred to in (i) through (vi) above.
In addition, no payments of additional amounts will be made with respect to any payment on a Note if the holder of the Note is a fiduciary, partnership or a person other than the sole beneficial owner of any payment, and, by the laws of the jurisdiction in which we are resident for tax purposes, that payment would be required for tax purposes to be included in income of a beneficiary or settlor with respect to the fiduciary, a member of that partnership or a beneficial owner who would not have been entitled to the additional amounts had that beneficiary, settlor, member or beneficial owner been the holder of the relevant Note.
We will remit the full amount of any taxes withheld to the applicable taxing authorities in accordance with the applicable law. We will also provide the trustee with documentation reasonably satisfactory to the trustee evidencing the payment of any taxes in respect of which we have paid additional amounts. We will provide copies of such documentation to the holders of the Notes upon request.
Any reference in this prospectus supplement, the Indenture or the Notes to principal, premium or interest in respect of the Notes will be deemed also to refer to any additional amounts that may be payable with respect to such principal, premium or interest under the obligations referred to in this subsection.
Defeasance and Discharge
We may release ourselves from any payment or other obligations on each series of Notes as described under “Description of Debt Securities — Satisfaction, Discharge and Defeasance” in the Base Prospectus.
Paying and Calculation Agent
The principal corporate trust office of the trustee in The City of New York is designated as the principal paying agent. See “— Trustee” immediately below. We may at any time designate additional paying agents or rescind the designation of paying agents or approve a change in the office through which any paying agent acts. The trustee will also serve as the calculation agent with respect to the Floating Rate Notes pursuant to a Calculation Agency Agreement to be dated as of August 17, 2018 between us and The Bank of New York Mellon.
Trustee
As a result of the transfer of JPMorgan Chase Bank’s corporate trust business to The Bank of New York Mellon (formerly known as The Bank of New York), effective October 1, 2006, The Bank of New York Mellon is the trustee under the Indenture. The trustee’s address is The Bank of New York Mellon, Corporate Trust Office, 101 Barclay Street, New York, NY 10286. The trustee will also serve as the paying agent for the Notes and as the calculation agent with respect to the Floating Rate Notes. See “— Paying and Calculation Agent” immediately above.
See “Description of Debt Securities — Concerning the Trustee” and “Description of Debt Securities — Default and Related Matters” in the Base Prospectus below for a description of the trustee’s procedures and remedies available in the event of default.
Base Prospectus:
DESCRIPTION OF DEBT SECURITIES
We may issue debt securities using this prospectus. As required by US federal law for all publicly offered corporate bonds and notes, the debt securities are governed by a document called an indenture. The indenture relating to the debt securities issued by us is a contract, dated as of April 1, 2004, between AstraZeneca PLC and JPMorgan Chase Bank, as trustee. As a result of the transfer of JPMorgan Chase Bank’s corporate trust business to The Bank of New York Mellon effective October 1, 2006, The Bank of New York Mellon is the trustee under the indenture. See “— The Trustee” below.
In this description “the security holder” means direct holders and not street name or other indirect holders of securities. Indirect holders should read the section “Legal Ownership — Street Names and Other Indirect Holders” in the Base Prospectus.
General
This section summarizes the material provisions of the indenture and the debt securities. Because it is a summary, it does not describe every aspect of the indenture or the debt securities. This summary is subject to and qualified in its entirety by reference to all of the indenture provisions, including some of the terms used and defined in the indenture. We describe the meaning of only the more important terms in this prospectus. We also include references in parentheses to some sections of the indenture. Whenever we refer to particular sections or defined terms of the indenture in this prospectus or in the applicable prospectus supplement, those sections or defined terms are incorporated by reference here or in the prospectus supplement. This summary is also subject to and qualified by reference to the description of the particular terms of the security holder’s series of debt securities described in the prospectus supplement.
The indenture and its associated documents contain the full legal text of the matters described in this section. The indenture and the debt securities are governed by New York law. The indenture is an exhibit incorporated by reference into this prospectus.
The debt securities are unsecured obligations of AstraZeneca PLC. The debt securities will rank equally in right of payment with all of our other unsecured and unsubordinated indebtedness except for indebtedness that is preferred under applicable law.
The Trustee
The Bank of New York Mellon (as successor trustee to JPMorgan Chase Bank) is the trustee under the indenture. As trustee, it has two main roles:
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first, it can enforce the security holder’s rights against us if we default on debt securities issued under the indenture. There are some limitations on the extent to which the trustee may act on the security holder’s behalf, described under “Defaults and Related Matters — Remedies if an event of default occurs” below; and |
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second, the trustee performs administrative duties for us, such as sending the security holder interest payments and notices. |
Types of Debt Securities
The indenture does not limit the amount of debt securities that we can issue. It provides that debt securities may be issued in one or more series up to the aggregate principal amount as we authorize from time to time. All debt securities of one series need not be issued at the same time and we may reopen any series, without the consent of a holder of that series, to issue additional debt securities of the same series.
The prospectus supplement relating to a series of debt securities will describe the following terms of the series:
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the title of the series of debt securities; |
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the aggregate principal amount of debt securities and any limit on the aggregate principal amount of the series of debt securities; |
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any stock exchange on which we will list the debt securities; |
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the date or dates on which we will repay the principal amount of the series of debt securities or the method by which the date or dates will be determined; |
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any rate or rates at which the series of debt securities will bear interest or the method by which the interest rate or rates will be determined; |
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the date or dates from which any interest on the series of debt securities will accrue, the dates on which interest will be payable and the record dates for interest payments or the method by which such date or dates will be determined and the method by which interest will be calculated if different to a 360-day year of twelve 30-day months; |
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the place or places where the principal and any interest on debt securities will be payable if other than the corporate trust office of the trustee in New York, New York; |
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the price or prices at which, the period or periods within which, the currency or currencies, currency unit or composite currency in which, and the terms and conditions upon which we may redeem the series of debt securities in whole or in part; |
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any right or obligation to redeem, repay or purchase the debt securities as a result of any sinking fund or similar provisions, or at the option of the holder of the debt securities and the period or periods within which, the price or prices at which and every other term and condition upon which the debt securities will be redeemed, repaid or purchased; |
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the denominations in which debt securities of the series are issuable, if other than denominations of $2,000 and any whole multiple of $1,000 in excess thereof; |
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the portion of the principal amount of the series of debt securities payable if an acceleration of the maturity of the debt securities is declared, if other than the principal amount; |
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the currency, including any composite currency, of payment of the principal, premium, if any, and interest on the series of debt securities if other than US dollars; |
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whether we or a holder of debt securities may elect to have the principal, premium, if any, or interest on the series of debt securities paid in a currency or composite currency other than the currency in which the debt securities are stated to be payable, and if so, any election period and the terms and conditions governing such an election; |
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whether we will be required to pay additional amounts for withholding taxes or other governmental charges and, if applicable, a related right to an optional tax redemption for such a series; |
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any index used to determine the amount of payment of principal, premium, if any, and interest on the series of debt securities and how these amounts will be determined if they are not fixed when the debt securities are issued; |
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the forms of the series of debt securities; |
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the applicability of the provisions described later under “— Satisfaction, Discharge and Defeasance”; |
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any authenticating or paying agents, transfer agents or registrars or any other agents acting in connection with the debt securities other than the trustee; |
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if applicable, a discussion of any additional or alternative material US federal income and UK tax considerations; and |
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any other special features of the series of debt securities. |
We may issue the debt securities as original issue discount securities, which are debt securities offered and sold at a substantial discount to their stated principal amount.
Overview of the Remainder of this Description
The remainder of this description summarizes:
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Additional mechanics relevant to the debt securities under normal circumstances, such as how the security holder transfers ownership and where we make payments. |
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The security holder’s right to receive payment of additional amounts due to changes in the tax withholding requirements of various jurisdictions. |
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The security holder’s rights under several special situations, such as if we merge with another company or if we want to redeem the debt securities for tax reasons. |
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Covenants contained in the indenture that restrict our ability to incur liens and undertake sale and leaseback transactions. A particular series of debt securities may have different covenants. |
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The security holder’s rights if we default. |
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The security holder’s rights if we want to modify the indenture. |
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Our relationship with the trustee. |
Additional Mechanics
Exchange and Transfer
The debt securities will be issued only in fully registered form without interest coupons in denominations of $2,000 or whole multiples of $1,000 in excess thereof. The security holder may have his or her debt securities broken into more debt securities of smaller denominations of whole multiples of $1,000 (but not less than a minimum denomination of $2,000) or combined into fewer debt securities of larger denominations of whole multiples of $1,000, as long as the total principal amount is not changed. This is called an exchange.
The security holder may exchange or transfer registered debt securities at the office of the trustee. The trustee acts as our agent for registering debt securities in the names of holders and for transferring registered debt securities. We may change this appointment to another entity or perform the service ourselves. The entity performing the role of maintaining the list of registered holders is called the security registrar. It will also register transfers of the registered debt securities.
The security holder may not exchange his or her registered debt securities for bearer securities.
There will be no service charge for any exchange or registration of transfer of the debt securities, but we may require payment of an amount sufficient to cover any tax or other governmental charge imposed in connection with any exchange or registration of transfer.
The transfer or exchange of a registered debt security may be made only if the security registrar is satisfied with the security holder’s proof of ownership.
If the debt securities are redeemable and we redeem less than all of the debt securities of a particular series, we may block the transfer or exchange of debt securities during a specified period of time in order to freeze the list of holders to prepare the mailing. The period begins 15 days before the day we first mail the notice of redemption and ends on the day of that mailing. We may also refuse to register transfers or exchanges of debt securities selected or called for redemption. However, we will continue to permit transfers and exchanges of the unredeemed portion of any security being partially redeemed.
Payment and Paying Agents
We will pay interest to the security holder if he or she is a direct holder of debt securities at the close of business on a particular day in advance of each due date for interest, even if the security holder no longer owns the security on the interest due date. That particular day, usually about two weeks in advance of the interest due date, is called the record date and is stated in the applicable prospectus supplement.
Unless provided otherwise in the applicable prospectus supplement, we will pay interest, principal and any other money due on debt securities in registered form at the corporate trust office of The Bank of New York Mellon (as successor paying agent to JPMorgan Chase Bank) in the Borough of Manhattan, The City and State of New York as paying agent for the debt securities. That office is located at The Bank of New York Mellon, 101 Barclay Street, New York, New York 10286. At our option, we may pay interest on any debt securities by check mailed to the registered holders.
Some of the debt securities may be denominated, and payments may be made, in currencies other than US dollars or in composite currencies. A summary of any special considerations which apply to these debt securities is in the applicable prospectus supplement.
Street name and other indirect holders should consult their banks or brokers for information on how they will receive payments.
We may arrange for additional payment offices, or may cancel or change these offices, including our use of the trustee’s corporate trust office. These offices are called paying agents. We may also choose to act as our own paying agent, but must always maintain a paying agency in the Borough of Manhattan, The City and State of New York. Whenever there are changes in the paying agents for any particular series of debt securities we must notify the trustee.
Payment of Additional Amounts
Unless provided otherwise in the applicable prospectus supplement, we agree that any amounts to be paid by us under any series of debt securities of principal, premium and interest in respect of the debt securities will be paid without deduction or withholding for, any and all present and future taxes, levies, duties, assessments, imposts or other governmental charges of whatever nature imposed, assessed, levied or collected by or for the account of the government of any jurisdiction in which we are resident for tax purposes (at the time of the issuance, the UK) or any political subdivision or taxing authority of such jurisdiction, unless such withholding or deduction is required by law. If such deduction or withholding is at any time required, we will (subject to compliance by the security holder with any relevant administrative requirements) pay such additional amounts as will result in the receipt of such amounts as would have been received by the holder had no such withholding or deduction been required.
The indenture provides that we will not have to pay additional amounts in certain specified circumstances, and that those circumstances may be modified or supplemented for different series of debt securities. Unless the applicable prospectus supplement for a series of debt securities provides otherwise, debt securities issued using this prospectus will provide that we will not have to pay additional amounts if:
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the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for the holder’s (or certain related parties’) connection to the jurisdiction in which we are resident for tax purposes, other than by merely holding the debt security or by receiving principal, premium, if any, or interest, if any, on the debt security, or enforcing the debt security. These connections include where the holder or related party: |
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is or has been a domiciliary, national or resident of such jurisdiction; |
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is or has been engaged in a trade or business in such jurisdiction; |
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has or had a permanent establishment in such jurisdiction; or |
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is or has been physically present in such jurisdiction. |
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the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for presentation of the debt security for payment, if presentation is required, more than 30 days after the security became due or payment was provided for; |
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the tax, levy, impost or other governmental charge is an estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge; |
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the tax, levy, impost or other governmental charge is payable in a manner that does not involve deduction or withholding from payments on or in respect of the relevant debt security; |
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the tax, levy, impost or other governmental charge would not have been imposed or withheld but for the failure of the holder or beneficial owner to comply with any certification, identification or other reporting requirement concerning the nationality, residence, identity or connection with any jurisdiction in which we are resident for tax purposes, as required by any treaty, statute, regulation or administrative practice of such jurisdiction as a condition to relief or exemption from such tax, levy, impost or other governmental charge; |
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the holder would have been able to avoid such withholding or deduction by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form required by the relevant tax authority, a declarative, claim, certificate, document or other evidence establishing exemption therefrom; |
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the tax, levy, impost or other governmental charge is imposed by the US or any political subdivision or taxing authority thereof or therein; |
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the holder of the debt security is a fiduciary, partnership or a person other than the sole beneficial owner of any payment that would be required, by the laws of the jurisdiction in which we are resident for tax purposes, to be included in income, for tax purposes, of a beneficiary or settlor with respect to the fiduciary, a member of that partnership or a beneficial owner who would not have been entitled to the additional amounts had that beneficiary, settlor, partner or beneficial owner been the holder; or |
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any combination of the exceptions listed above. |
Mergers and Similar Events
We are generally permitted to consolidate or merge with another company or other entity that is organized under the laws of the UK, the US or any other country which is a member of the Organization for Economic Cooperation and Development. We are also generally permitted to sell or convey our property as an entirety or substantially as an entirety to such other entity. Our ability to take some of these actions is restricted in the following ways:
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any entity succeeding us must assume our obligations in relation to the debt securities and under the indenture; and |
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if the succeeding entity is not organized under the laws of the UK or a State of the United States, the succeeding entity’s assumption of our obligations in relation to the debt securities and under the indenture must include the obligation to pay any additional amounts as described under “— Payment of Additional Amounts”. |
It is possible that the merger, sale, or lease of all or substantially all of our assets would cause a principal property of ours or of a restricted subsidiary of ours or shares of stock or indebtedness of any of our restricted subsidiaries to become subject to a lien giving other lenders preferential rights in that property over holders of debt securities. We have promised to limit these preferential rights on our property, called liens, as discussed under “— Limitation on Liens”. If a merger or other transaction would create any impermissible liens on our property, we must grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
Optional Tax Redemption
Unless provided otherwise in the applicable prospectus supplement, we have the option to redeem the debt securities in the two situations described below. The redemption price for the debt securities, other than original issue discount debt securities, will be equal to the principal amount of the debt securities being redeemed plus accrued interest and any additional amounts due on the date fixed for redemption. The redemption price for original issue discount debt securities will be specified in the applicable prospectus supplement.
We must give the security holder between 30 and 60 days’ notice before redeeming the debt securities.
The first situation is where, as a result of a change or amendment to any law or related regulation or ruling of the jurisdiction in which we are resident for tax purposes, or any change in an application or interpretation of such laws, regulations or rulings, or any change in application or interpretation of, or any execution of an amendment to, any treaty, we would have to pay additional amounts as described under “—Payment of Additional Amounts”.
This first situation applies only in the case of changes, amendments, applications, interpretations or executions that occur on or after the date specified in the prospectus supplement for the applicable series of debt securities (or if no such date is specified, the first date on which debt securities of such series were issued). If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes, and the applicable date will be the date such entity became successor, rather than the date specified in the preceding sentence.
The second situation is where our independent legal advisor has advised us that, as a result of action taken by a taxation authority of, or any action brought in a court of competent jurisdiction in, the jurisdiction in which we are resident for tax purposes, after the date specified in the prospectus supplement for the applicable series of debt securities, we would have to pay additional amounts as described under “—Payment of Additional Amounts” and the payment of such additional amounts cannot be avoided by the use of reasonable measures available to us. If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes and the applicable date will be the date such entity became our successor.
Covenants
Limitation on Liens
Some of our property and the property of our subsidiaries may be subject to a mortgage, pledge, assignment, charge or other legal mechanism that gives a lender preferential rights in that property over other lenders, including the security holder and the other direct holders of the debt securities, or over our general creditors if we fail to repay them. These preferential rights are generally called liens.
We undertake that we and certain of our subsidiaries, which we refer to as “restricted subsidiaries”, will not become obligated on any new debt for borrowed money that is secured by a lien on any principal property or on any shares of stock or indebtedness of any of our restricted subsidiaries unless we grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
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Restricted subsidiary means any wholly-owned subsidiary: |
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with substantially all of its property located within the UK or the US; and |
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which owns a principal property; |
but does not include any wholly-owned subsidiary principally engaged in leasing or in financing installment receivables or principally engaged in financing the operations of us and our consolidated subsidiaries.
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A wholly-owned subsidiary means any corporation in which control, directly or indirectly, of all of the stock with ordinary voting power to elect the board of directors of that corporation is owned by us, or by one or more of our wholly-owned subsidiaries or by us and one or more of our wholly-owned subsidiaries. |
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A subsidiary, with respect to any person, is any corporation in which that person owns or controls directly or indirectly at least a majority of stock with ordinary voting power to elect a majority of the board of directors. |
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Principal property means any manufacturing plant or facility or any research facility owned by us or any restricted subsidiary. A principal property must also be located within the UK or the US and have a |
gross book value (before deducting any depreciation reserve) exceeding 2% of our consolidated net tangible assets. Principal property does not include:
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any plant or facility or research facility which in the opinion of our board of directors is not materially important to the total business conducted by us and our subsidiaries; or |
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any portion of a property described above which, in the opinion of our board of directors, is not materially important to the use or operation of the property. |
We do not need to comply with this restriction if the amount of all debt that would be secured by liens on our principal properties and the shares of stock or indebtedness of our restricted subsidiaries is no more than 15% of our consolidated net tangible assets.
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Our consolidated net tangible assets mean AstraZeneca PLC’s consolidated total assets, after deducting: |
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all liabilities due within one year (other than short-term borrowings and long-term debt due within one year); and |
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all goodwill, trade names, trademarks, patents and other similar types of intangible assets as shown on the audited consolidated balance sheet contained in the latest annual report to our shareholders. |
This restriction on liens does not apply to debt secured by a number of different types of liens. These types of liens include the following:
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any lien on property, shares of stock or indebtedness of any corporation existing at the time the corporation becomes a restricted subsidiary; |
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any lien on property or shares of stock existing at the time of acquisition of that property or those shares of stock, or to secure the payment of all or any part of the purchase price of that property or those shares of stock, or to secure any debt incurred before, at the time of, or within twelve months after, in the case of shares of stock, the acquisition of the shares of stock and, in the case of property, the later of the acquisition, completion of construction (including any improvements on an existing property) or commencement of the commercial operation of the property, where the debt is incurred to finance all or any part of the purchase price; |
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any lien securing debt owed to us or to any of our restricted subsidiaries by us or any of our restricted subsidiaries; |
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any lien existing at the date of the indenture; |
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any lien on a principal property to secure debt incurred to finance all or part of the cost of improving, constructing, altering or repairing any building, equipment or facilities or of any other improvements on all or any part of that principal property, if the debt is incurred before, during, or within twelve months after completing the improvement, construction, alteration or repair; |
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any lien on property owned or held by any corporation or on shares of stock or indebtedness of any corporation, where the lien existed either at the time the corporation is merged, consolidated or amalgamated with either us or a restricted subsidiary or at the time of a sale, lease or other disposition of all or substantially all of the property of a corporation to us or a restricted subsidiary; |
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any lien arising by operation of law and not securing amounts more than 90 days overdue or otherwise being contested in good faith; |
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any lien arising by operation of law over any credit balance or cash held in any account with a financial institution; |
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any rights of financial institutions to offset credit balances in connection with the operation of cash management programs established for our benefit and/or the benefit of any restricted subsidiary; |
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any lien incurred or deposits made in the ordinary course of business, including but not limited to: |
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any mechanics’, materialmen’s, carriers’, workmen’s, vendors’ or other similar liens; |
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any liens securing amounts in connection with workers’ compensation, unemployment insurance and other types of social security; and |
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any easements, rights-of-way, restrictions and other similar charges; |
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any liens incurred or deposits made securing the performance of tenders, bids, leases, statutory obligations, surety and appeal bonds, government contracts, performance and return of money bonds and other obligations of a similar nature incurred in the ordinary course of business; |
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any lien securing taxes or assessments or other applicable governmental charges or levies; |
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any extension, renewal or replacement or successive extensions, renewals or replacements, in whole or in part, of any lien included in the preceding paragraphs or of any of the debt secured under the preceding paragraphs, so long as the principal amount of debt secured does not exceed the principal amount of debt secured at the time of the extension, renewal or replacement, and that the extension, renewal or replacement lien is limited to all or any part of the same property or shares of stock that secured the lien extended, renewed or replaced (including improvements on that property), or property received or shares of stock issued in substitution or exchange; and |
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any lien in favor of us or any subsidiary of ours. |
The following types of transactions will not be deemed to create debt secured by a lien and, therefore, will also not be subject to the restriction on liens:
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any liens on property of ours or a restricted subsidiary in favor of the US or any State of the US, or the UK, or any other country, or any political subdivision of, or any department, agency or instrumentality of, these countries or states, to secure partial, progress, advance or other payments under provisions of any contract or statute including, but not limited to, liens to secure debt of pollution control or industrial revenue bond type, or to secure any indebtedness incurred for the purpose of financing all or any part of the purchase price or cost of construction of the property subject to these liens. |
Limitation on Sale and Lease-Back Transactions
Neither we nor any of our restricted subsidiaries will enter into any sale and lease-back transaction involving a principal property without complying with this covenant.
A sale and lease-back transaction is an arrangement between us or a restricted subsidiary and any person in which we or the restricted subsidiary leases back for a term of more than three years a principal property that we or the restricted subsidiary has sold or transferred to that person.
We and our restricted subsidiaries may enter into sale and lease-back transactions provided that the total amount of attributable debt attributable to all sale and lease-back transactions plus other debt of ours or any of our restricted subsidiaries that is secured by liens (but excluding debt secured by liens on property that we or a restricted subsidiary would be entitled to incur, assume or guarantee without equally and ratably securing the debt securities offered by this prospectus as described under “— Limitation on Liens” above) does not exceed 15% of consolidated net tangible assets.
This restriction does not apply to any sale and lease-back transaction if:
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we or the restricted subsidiary seeking to enter into the sale and lease-back could incur, assume or guarantee debt secured by a lien on the principal property to be leased without equally and ratably securing the debt securities offered by this prospectus as a result of one or more of the exceptions to the limitation on liens as described under “— Limitation on Liens” above; |
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within twelve months before or after the sale or transfer, regardless of whether the sale or transfer may have been made by us or a restricted subsidiary, we apply, an amount equal to the net proceeds of the |
sale or transfer (in the case of a sale or transfer for cash), or an amount equal to the fair value of the principal property so leased at the time of entering into the sale or transfer as determined by our board of directors (in the case of a sale or transfer otherwise than for cash), to
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the retirement of indebtedness for money borrowed, incurred or assumed by us or any restricted subsidiary which matures at, or is extendible or renewable at the option of the obligor to, a date more than twelve months after the date of incurring, assuming or guaranteeing such debt, or |
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investment in any principal property or principal properties. |
This restriction on sale and lease-back transactions also does not apply to any transaction between us and a restricted subsidiary, or between restricted subsidiaries.
Attributable debt means the present value (discounted at a rate equal to the weighted average of the rate of interest on all securities then issued and outstanding under the indenture, compounded semi-annually) of our or a restricted subsidiary’s obligation for rental payments for the remaining term of any lease in a sale and lease-back transaction.
Default and Related Matters
Events of Default
A holder of debt securities of a particular series will have special rights if any event of default occurs with respect to that series and is not cured, as described later in this subsection.
What is an event of default? An event of default means any of the following:
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Interest — default for 30 days in the payment of any installment of interest on the series of debt securities; |
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Principal — default in the payment of all or any part of the principal of the series of debt securities when such principal becomes due and payable either at maturity, upon redemption, by acceleration or otherwise; |
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Sinking Fund Installment — default in the payment of any sinking fund installment as and when such installment becomes due and payable by the specific terms of the series of debt securities or beyond any period of grace; |
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Covenant — breach or default by us in the performance of a covenant or warranty in respect of the debt securities of the relevant series which has not been remedied for ninety days after we receive written notice of the default from the trustee or we and the trustee receive written notice of the default from the holders of at least 25% of the principal amount of the debt securities of all affected series; |
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Bankruptcy — certain events of bankruptcy, insolvency or reorganization affecting us; or |
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Other — any other event of default provided in any supplemental indenture or resolution of our board of directors under which a particular series is issued or in the form of security for such series. |
No event of default described in the provisions above with respect to a particular series of debt securities will necessarily constitute an event of default with respect to any other series of debt securities and the events of default for any specific series may be modified as described in the applicable prospectus supplement.
Remedies if an event of default occurs. If an event of default, other than a “Bankruptcy” default, has occurred (but only if, in the case of a “Covenant” default, the default has occurred for less than all series of debt securities then issued under the indenture and outstanding) and has not been cured, the trustee or the holders of at least 25% of the principal amount of debt securities of the affected series (each affected series voting as a separate class) may declare the principal amount (or, if the debt securities of a series are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all the debt securities of that series, together with any accrued interest, to be due and payable immediately.
If an event of default has occurred under “Covenant” default with respect to all of the series of debt securities then issued under the indenture and outstanding, or under “Bankruptcy” default, and has not been cured, the trustee or the holders of at least 25% of the principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class) may declare the principal (or, if any debt securities are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all debt securities then issued under the indenture and outstanding, together with any accrued interest, to be due and payable immediately. This is called a declaration of acceleration of maturity. A declaration of acceleration of maturity may be canceled by the holders of at least a majority in principal amount of the debt securities of the affected series or by at least a majority in principal amount of all the debt securities then issued under the indenture and outstanding (voting as one class), as the case may be, if certain conditions are met.
Before a declaration of acceleration of maturity, past “Covenant” defaults that do not affect all series of debt securities then issued under the indenture and outstanding may be waived by the holders of a majority in principal amount of the debt securities then outstanding of each affected series (each such series voting as a separate class). Past “Covenant” defaults that affect all series of debt securities then issued under the indenture and outstanding and past “Bankruptcy” defaults may be waived by the holders of a majority in principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class). Default in the payment of principal of or interest on or any sinking fund installment of debt securities of any series or a covenant or provision of the indenture that cannot be modified or amended without the consent of the holder of each debt security affected may only be modified or amended with the consent of such holder.
Except in cases of default, where the trustee has some special duties, the trustee is not required to take any action under the indenture at the request of any holders unless the holders offer the trustee reasonable protection from expenses and liability. This protection is called an indemnity. If reasonable indemnity is provided, the holders of a majority in principal amount of the outstanding debt securities of the relevant series may, subject to certain limitations and conditions, direct the time, method and place of conducting any lawsuit or other formal legal action seeking any remedy available to the trustee. These majority holders may also, subject to certain limitations and conditions, direct the trustee in performing any other action under the indenture.
Before the security holder bypasses the trustee and bring his or her own lawsuit or other formal legal action or takes other steps to enforce his or her rights or protects his or her interests relating to the debt securities, the following must occur:
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the security holder must give the trustee written notice that an event of default has occurred and remains uncured; |
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the holders of 25% in principal amount of all outstanding debt securities of the relevant series must make a written request that the trustee take action because of the default, and must offer reasonable indemnity to the trustee against the cost and other liabilities of taking that action; and |
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the trustee must have not taken action for 60 days after receipt of the above notice and offer of indemnity and the trustee has not received an inconsistent direction from the holders of a majority in principal amount of all outstanding debt securities of the relevant series during that period. |
These limitations do not apply to a suit instituted by the security holder for the enforcement of payment of the principal or interest on a debt security on or after the respective due dates.
We will file annually with the trustee on or before March 31 in each year a written statement of certain of our officers certifying that, to their knowledge, we have not defaulted on our covenants under the indenture or else specifying any default that exists.
For any series of debt securities that is a series of original issue discount securities the applicable prospectus supplement will contain provisions for the acceleration of the maturity of a portion of the principal amount of such original issue discount securities.
Modification of the Indenture and Waiver
There are three types of changes we can make to the indenture and any series of the debt securities.
Changes not requiring approval. The first type of change does not require any vote by holders of debt securities. The security holder’s consent is not required to do any of the following:
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to transfer or pledge any property or assets to the trustee as security for any series of the debt securities; |
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to evidence the succession of any successor corporation to us as described under “Mergers and Similar Events” above; |
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to evidence the succession of any successor trustee under the indenture or to add to or change any provisions of the indenture as necessary to provide for the appointment of an additional trustee or trustees; |
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to add to our covenants or to add additional events of default for the benefit of the holders of any series of the debt securities; |
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to cure any ambiguity or to correct or supplement any provision of the indenture that may be defective or inconsistent with any other provision of the indenture; or |
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to make any other provisions with respect to matters or questions arising under the indenture as our board of directors may deem necessary or desirable and that shall not adversely affect the interests of holders of any series of the debt securities in any material respect. |
Changes requiring the approval of a majority of holders. The second type of change to the indenture and the debt securities requires a vote in favor by holders of debt securities owning at least a majority of the principal amount of all series of debt securities then outstanding and affected by such charge (each affected series voting as a separate class). In this manner, any provision of the indenture or any series of debt securities may be changed or eliminated unless the provision relates to a matter that requires the consent of each affected holder as discussed below.
Changes requiring the security holder’s approval. Third, there are changes that cannot be made to the security holder’s debt securities without the specific approval of each affected holder. The security holder’s consent is required before we could do any of the following:
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extend the final maturity of a debt security; |
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reduce the principal amount of a debt security; |
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reduce the rate or extend the time of payment of any interest on a debt security; |
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reduce any amount payable on redemption of a debt security; |
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reduce the amount of principal due and payable upon an acceleration of the maturity or provable in bankruptcy of a debt security issued at an original issue discount; |
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impair the security holder’s right to sue for payment; |
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impair any right of repayment at the option of the holder; |
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reduce the percentage of holders of debt securities whose consent is needed to modify or amend the indenture; or |
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change in any manner adverse to the holders of the debt securities our obligations relating to the payment of principal and interest, and sinking fund payments. |
Satisfaction, Discharge and Defeasance
We may terminate our repayment and obligations on the debt securities, when:
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we have paid or caused to be paid the principal of and interest, if any, then due and payable on all outstanding debt securities of any series; or |
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we have delivered to the trustee for cancellation all outstanding debt securities of any series; or |
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all the outstanding debt securities of the series that have not been delivered to the trustee for cancellation have become or will become due and payable within one year and we have made arrangements satisfactory to the trustee for the giving of notice of redemption by the trustee in our name; and |
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we have deposited with the trustee sufficient funds to pay and discharge the entire indebtedness on the series of debt securities to pay principal and interest, if any, and paid all other sums payable under the indenture. |
We may legally release ourselves from any payment or other obligations on the debt securities, except for various obligations described below, if we, in addition to other actions, put in place the following arrangements for the security holder:
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we must deposit in trust for the security holder’s benefit and the benefit of all other direct holders of the debt securities a combination of money and government obligations that will generate enough cash to make interest, principal and any other payments on the debt securities on their various due dates; and |
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we must deliver to the trustee a legal opinion of our counsel to the effect that the holders of the debt securities of that series will not recognize gain or loss for US federal income tax purposes as a result of the defeasance and will be subject to the same US federal income tax as would be the case if the defeasance did not occur. |
However, even if we take these actions, a number of our obligations relating to the debt securities will remain. These include the following obligations:
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to register the transfer and exchange of debt securities and our right of optional redemption, if any; |
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to replace mutilated, defaced, destroyed, lost or stolen debt securities; |
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to pay principal and interest, if any, on the original stated due dates and any remaining rights of the holders to receive sinking fund payments, if any, from funds deposited with the trustee; |
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immunities of the trustee; and |
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to hold money for payment in trust. |
Government obligation means securities that are:
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direct obligations of the US or any foreign government of a sovereign state for the payment of which is pledged by the full faith and credit of the US or such foreign government; or |
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obligations of an entity controlled or supervised by and acting as an agency or instrumentality of the US or any foreign government of a sovereign state the payment of which is unconditionally guaranteed as a full faith and credit obligation of the US or such foreign government; |
and are not callable or redeemable at the option of the issuer. Government obligation also includes:
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a depositary receipt issued by a bank or trust company as custodian for these government obligations, or specific payment of interest on or principal of these government obligations, held by such custodian for the account of the holder of a depositary receipt, provided that (except as required by law) such custodian is not authorized to make any deductions from the amount payable to the holder of such depositary receipt from any amount received by the custodian in respect of these government obligations, or the specific payment of interest on or principal of these government obligations, evidenced by such depositary receipt. |
Notices
We and the trustee will send notices only to direct holders, using their addresses registered in the trustee’s records.
Regardless of who acts as paying agent, all money that we pay to a paying agent that remains unclaimed at the end of two years after the amount is due to direct holders of debt securities will be repaid to us. After that two-year period, the security holder may look only to us for payment and not to the trustee, any other paying agent or anyone else.
Governing Law
The debt securities and the indenture will be governed by and construed in accordance with the laws of the State of New York.
Concerning the Trustee
The Bank of New York Mellon acts as the trustee with respect to certain debt securities of certain of our subsidiaries.
If an event of default occurs, or an event occurs that would be an event of default if the requirements for either giving us notice or our default having to exist for a specified time period were disregarded, the trustee may be considered to have a conflicting interest with respect to the debt securities or the indenture for purposes of the Trust Indenture Act of 1939. In that case, the trustee may be required to resign as trustee under the applicable indenture and we would be required to appoint a successor trustee.
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3.375% Notes due 2025 and 4.375% Notes due 2045 |
Prospectus Supplement:
DESCRIPTION OF NOTES
General
We offered $2,000,000,000 initial aggregate principal amount of 3.375% Notes due 2025 (the “2025 Notes”), $1,000,000,000 initial aggregate principal amount of 4.375% Notes due 2045 (the “2045 Notes” and, collectively with the 2025 Notes, the “Fixed Rate Notes” or the “notes”), each as a separate series of notes under the Indenture, and, as such, each series of notes vote and act, and may be redeemed, separately. The notes are governed by New York law.
The notes are unsecured, unsubordinated indebtedness of AstraZeneca PLC and rank equally with all of AstraZeneca PLC’s other unsecured and unsubordinated indebtedness from time to time outstanding.
There is no sinking fund for any series of notes. We have listed the notes on the Nasdaq Stock Market LLC.
Interest Payments and Maturity
For purposes of the description below, “business day” means any day which is not, in London, England or New York, New York, or the place of payment of amounts payable in respect of the notes, a Saturday, a Sunday, a legal holiday or a day on which banking institutions are authorized or obligated by law, regulation or executive order to close. A “London business day” is a day on which dealings in deposits in U.S. dollars are transacted in the London interbank market.
Fixed Rate Notes
Maturity. The entire principal amount of the 2025 Notes and the 2045 Notes will mature and become due and payable, together with any accrued and unpaid interest, on November 16, 2020, November 16, 2025 and November 16, 2045, respectively.
Interest Rate. Each of the 2025 Notes and the 2045 Notes will bear interest from their respective original issue date until their principal amount is paid or made available for payment, at a rate equal to 2.375%, 3.375% and 4.375% per annum, respectively, calculated on the basis of a 360-day year and twelve 30-day months.
Interest Payment Dates. Interest on the Fixed Rate Notes will be paid semi-annually in arrears on May 16 and November 16 of each year, commencing May 16, 2016 (each a “Fixed Rate Interest Payment Date”). However, if a Fixed Rate Interest Payment Date would fall on a day that is not a business day, the Fixed Rate Interest Payment Date will be postponed to the next succeeding day that is a business day, but no additional interest shall be paid unless we fail to make payment on such date.
Interest Periods. The first interest period for the Fixed Rate Notes will be the period from and including the issue date to but excluding the first Fixed Rate Interest Payment Date. Thereafter, the interest periods for the Fixed Rate Notes will be the periods from and including the Fixed Rate Interest Payment Dates to but excluding the immediately succeeding Fixed Rate Interest Payment Date (together with the first interest period, each a “Fixed Rate Interest Period”). The final Fixed Rate Interest Period will be the period from and including the Fixed Rate Interest Payment Date immediately preceding the maturity date to the maturity date.
Redemption
As explained below, under certain circumstances we may redeem the notes before they mature. This means that we may repay them early. If we redeem one series of notes we will have no obligation to redeem any other series. The security holder has no right to require us to redeem the notes. Notes will stop bearing interest on the redemption date, even if the security holder does not collect his or her money. We will give notice to DTC of any redemption we propose to make at least 30 days, but no more than 60 days, before the redemption date. Notice by DTC to participating institutions and by these participants to street name holders of indirect interests in the notes will be made according to arrangements among them and may be subject to statutory or regulatory requirements.
Optional Redemption
We may redeem the Fixed Rate Notes, in whole or in part, at any time and from time to time at a redemption price equal to the greater of (i) 100% of the principal amount of such series of Fixed Rate Notes, and (ii) as determined by the Quotation Agent, the sum of the present values of the remaining scheduled payments of principal and interest on the series of Fixed Rate Notes to be redeemed (not including any portion of such payments of interest accrued as of the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the treasury rate plus the Make-Whole Spread (as set forth below) plus, in each case, accrued interest thereon to the date of redemption. In connection with such optional redemption, the following defined terms apply:
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“Treasury rate” means, with respect to any redemption date, the rate per annum equal to the semiannual equivalent yield to maturity of the comparable treasury issue, assuming a price for the comparable treasury issue (expressed as a percentage of its principal amount) equal to the comparable treasury price for such redemption date. |
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“Comparable treasury issue” means the United States Treasury security selected by the Quotation Agent as having a maturity comparable to the remaining term of the applicable series of Fixed Rate Notes to be redeemed that would be utilized, at the time of selection and in accordance with customary financial practice, in pricing new issues of corporate debt securities of comparable maturity to the remaining term of such series of Fixed Rate Notes. |
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“Comparable treasury price” means, with respect to any redemption date, (i) the average, as determined by the Quotation Agent, of the reference treasury dealer quotations for such redemption date, after excluding the highest and lowest such reference treasury dealer quotations, or (ii) if the Quotation Agent obtains fewer than three such reference treasury dealer quotations, the average of all such quotations. |
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“Quotation Agent” means the reference treasury dealer appointed by us. |
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“Reference treasury dealer” means (i) each of Barclays Capital Inc., HSBC Securities (USA) Inc., Merrill Lynch, Pierce, Fenner & Smith Incorporated and Morgan Stanley & Co. LLC, and their respective successors or affiliates; provided, however, that if the foregoing shall cease to be a primary US government securities dealer in New York City (a “primary treasury dealer”), we shall substitute therefor another primary treasury dealer; and (ii) any other primary treasury dealer selected by us. |
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“Reference treasury dealer quotations” means, with respect to each reference treasury dealer and any redemption date, the average, as determined by the Quotation Agent, of the bid and asked prices for the comparable treasury issue (expressed in each case as a percentage of its principal amount) quoted in writing to the trustee by such reference treasury dealer at 5:00 p.m., Eastern Standard Time, on the third business day preceding such redemption date. |
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“Make-Whole Spread” means, with respect to, (i) the 2025 Notes, 20 basis points and (ii) the 2045 Notes, 25 basis points. |
Optional Tax Redemption
In the event of various tax law changes after the date of this prospectus supplement and other limited circumstances that require us to pay additional amounts, as described below under “— Payment of Additional Amounts”, we may redeem all, but not less than all, of each series of notes at a price equal to 100% of the principal amount of each series of notes plus accrued interest to the date of redemption. This means we may repay any one or each series of notes early. We discuss our ability to redeem the notes in greater detail under “Description of Debt Securities — Optional Tax Redemption” in the accompanying prospectus.
Further Issuances
We may, without the consent of the holders of any series of notes, issue additional notes of each or any such series having the same ranking and same interest rate, maturity date, redemption terms and other terms as the applicable series of notes described in this prospectus supplement. Any such additional notes, together with the applicable series of notes offered by this prospectus supplement, will constitute a single series of securities under the Indenture. There is no limitation on the amount of notes or other debt securities that we may issue under such indenture.
We may offer additional notes of any series of notes with OID for US federal income tax purposes as part of a further issue. Purchasers of notes of such series after the date of any further issue will not be able to differentiate between notes sold as part of such further issue and previously issued notes. If we were to issue additional notes with OID, purchasers of notes after such further issue may be required to accrue OID with respect to their notes. This may affect the price of outstanding notes of such series following a further issue. Purchasers are advised to consult legal counsel with respect to the implications of any future decision by us to undertake a further issue of notes of any series with OID.
Form, Denomination, Clearance and Settlement
We will issue the notes in fully registered form. Each series of notes will be represented by one or more global securities registered in the name of a nominee of DTC. The security holder will hold beneficial interests in the notes through DTC in book-entry form. The notes will be issued in minimum denominations of $2,000 and in integral multiples of $1,000 in excess thereof. The underwriters expect to deliver the notes through the facilities of DTC on November 16, 2015. Indirect holders trading their beneficial interests in the notes through DTC must trade in DTC’s same-day funds settlement system and pay in immediately available funds. Secondary market trading through Euroclear and Clearstream, Luxembourg will occur in the ordinary way following the applicable rules and operating procedures of Euroclear and Clearstream, Luxembourg.
Payment of principal of and interest on each series of notes, so long as the notes are represented by global securities, as discussed below, will be made in immediately available funds. Beneficial interests in the global securities will trade in the same-day funds settlement system of DTC, and secondary market trading activity in such interests will therefore settle in same-day funds.
Payment of Additional Amounts
We agree that any amounts to be paid by us under the notes of principal, premium and interest in respect of the notes will be paid without deduction or withholding for, any and all present and future taxes, levies, duties, assessments, imposts or other governmental charges of whatever nature imposed, assessed, levied or collected by or for the account of the government of any jurisdiction in which we are resident for tax purposes (at the time of the issuance, the UK) or any political subdivision or taxing authority of such jurisdiction, unless such withholding or deduction is required by law. If such deduction or withholding is at any time required, we will (subject to compliance by the security holder with any relevant administrative requirements) pay such additional amounts as will result in the receipt of such amounts as would have been received by the holder had no such withholding or deduction been required, provided that we will not have to pay additional amounts if:
(i) the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for the holder’s connection to the jurisdiction in which we are resident for tax purposes, other than by merely holding the note or by receiving principal, premium, if any, or interest, if any, on the note, or enforcing the note. These connections include where the holder or related party:
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is or has been a domiciliary, national or resident of such jurisdiction; |
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is or has been engaged in a trade or business in such jurisdiction; |
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has or had a permanent establishment in such jurisdiction; or |
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is or has been physically present in such jurisdiction. |
(ii) the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for presentation of the note for payment, if presentation is required, more than 30 days after the security became due or payment was provided for;
(iii) the tax, levy, impost or other governmental charge is an estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge;
(iv) the tax, levy, impost or other governmental charge is payable in a manner that does not involve deduction or withholding from payments on or in respect of the relevant note;
(v) the tax, levy, impost or other governmental charge would not have been imposed or withheld but for the failure of the holder or beneficial owner to comply with any certification, identification or other reporting requirement concerning the nationality, residence, identity or connection with any jurisdiction in which we are resident for tax purposes, as required by any treaty, statute, regulation or administrative practice of such jurisdiction as a condition to relief or exemption from such tax, levy, impost or other governmental charge;
(vi) the tax, levy, impost or other governmental charge is required to be made pursuant to the European Union Directive 2003/48/EC on the taxation of savings or any other directive amending, supplementing or replacing such Directive or any law implementing or complying with, or introduced in order to conform to, such Directive or directives;
(vii) the holder would have been able to avoid such withholding or deduction by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form required by the relevant tax authority, a declarative, claim, certificate, document or other evidence establishing exemption therefrom;
(viii) the holder would have been able to avoid such withholding or deduction by presenting the relevant note to another paying agent in a Member State of the EU or elsewhere;
(ix) the tax, levy, impost or other governmental charge is required by Sections 1471 through 1474 of the Code (“FATCA”), any current or future U.S. Treasury Regulations or rulings promulgated thereunder, any intergovernmental agreement between the United States and any other jurisdiction to implement FATCA (an “IGA”), any law, regulation or other official guidance enacted in any jurisdiction implementing FATCA or an IGA, or any agreement with the U.S. Internal Revenue Service under or with respect to FATCA; or
(x) any combination of the taxes referred to in (i) through (ix) above.
In addition, no payments of additional amounts will be made with respect to any payment on a note if the holder of the note is a fiduciary, partnership or a person other than the sole beneficial owner of any payment that would be required, by the laws of the jurisdiction in which we are resident for tax purposes, to be included in income, for tax purposes, of a beneficiary or settlor with respect to the fiduciary, a member of that partnership or a beneficial owner who would not have been entitled to the additional amounts had that beneficiary, settlor, partner or beneficial owner been the holder of the relevant notes.
Defeasance and Discharge
We may release ourselves from any payment or other obligations on each series of notes as described under “Description of Debt Securities — Satisfaction, Discharge and Defeasance” in the Base Prospectus.
Paying and Calculation Agent
The principal corporate trust office of the trustee in The City of New York is designated as the principal paying agent. See “— Trustee” immediately below. We may at any time designate additional paying agents or rescind the designation of paying agents or approve a change in the office through which any paying agent acts.
Trustee
As a result of the transfer of JPMorgan Chase Bank’s corporate trust business to The Bank of New York Mellon (formerly known as The Bank of New York), effective October 1, 2006, The Bank of New York Mellon is the trustee under the Indenture. The trustee’s address is The Bank of New York Mellon, Corporate Trust Office, 101 Barclay Street, New York, NY 10286. The trustee will also serve as the paying agent for the notes. See “— Paying and Calculation Agent” immediately above.
Base Prospectus:
DESCRIPTION OF DEBT SECURITIES
The debt securities are unsecured obligations of AstraZeneca PLC. The debt securities will rank equally in right of payment with all of our other unsecured and unsubordinated indebtedness except for indebtedness that is preferred under applicable law.
The Trustee
The Bank of New York Mellon (as successor trustee to JPMorgan Chase Bank) is the trustee under the indenture. As trustee, it has two main roles:
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first, it can enforce the security holder’s rights against us if we default on debt securities issued under the indenture. There are some limitations on the extent to which the trustee may act on the security holder’s behalf, described under “Defaults and Related Matters - Remedies if an event of default occurs” below; and |
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second, the trustee performs administrative duties for us, such as sending the security holder interest payments and notices. |
Types of Debt Securities
The indenture does not limit the amount of debt securities that we can issue. It provides that debt securities may be issued in one or more series up to the aggregate principal amount as we authorize from time to time. All debt securities of one series need not be issued at the same time and we may reopen any series, without the consent of a holder of that series, to issue additional debt securities of the same series.
The prospectus supplement relating to a series of debt securities will describe the following terms of the series:
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the title of the series of debt securities; |
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the aggregate principal amount of debt securities and any limit on the aggregate principal amount of the series of debt securities; |
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any stock exchange on which we will list the debt securities; |
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the date or dates on which we will repay the principal amount of the series of debt securities or the method by which the date or dates will be determined; |
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any rate or rates at which the series of debt securities will bear interest or the method by which the interest rate or rates will be determined; |
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the date or dates from which any interest on the series of debt securities will accrue, the dates on which interest will be payable and the record dates for interest payments or the method by which such date or dates will be determined and the method by which interest will be calculated if different to a 360-day year of twelve 30-day months; |
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the place or places where the principal and any interest on debt securities will be payable if other than the corporate trust office of the trustee in New York, New York; |
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the price or prices at which, the period or periods within which, the currency or currencies, currency unit or composite currency in which, and the terms and conditions upon which we may redeem the series of debt securities in whole or in part; |
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any right or obligation to redeem, repay or purchase the debt securities as a result of any sinking fund or similar provisions, or at the option of the holder of the debt securities and the period or periods within which, the price or prices at which and every other term and condition upon which the debt securities will be redeemed, repaid or purchased; |
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the denominations in which debt securities of the series are issuable, if other than denominations of $2,000 and any whole multiple of $1,000 in excess thereof; |
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the portion of the principal amount of the series of debt securities payable if an acceleration of the maturity of the debt securities is declared, if other than the principal amount; |
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the currency, including any composite currency, of payment of the principal, premium, if any, and interest on the series of debt securities if other than US dollars; |
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whether we or a holder of debt securities may elect to have the principal, premium, if any, or interest on the series of debt securities paid in a currency or composite currency other than the currency in which the debt securities are stated to be payable, and if so, any election period and the terms and conditions governing such an election; |
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whether we will be required to pay additional amounts for withholding taxes or other governmental charges and, if applicable, a related right to an optional tax redemption for such a series; |
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any index used to determine the amount of payment of principal, premium, if any, and interest on the series of debt securities and how these amounts will be determined if they are not fixed when the debt securities are issued; |
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the forms of the series of debt securities; |
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the applicability of the provisions described later under “- Satisfaction, Discharge and Defeasance”; |
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any authenticating or paying agents, transfer agents or registrars or any other agents acting in connection with the debt securities other than the trustee; |
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if applicable, a discussion of any additional material US federal income and UK tax considerations; and |
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any other special features of the series of debt securities. |
Overview of the Remainder of this Description
The remainder of this description summarizes:
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Additional mechanics relevant to the debt securities under normal circumstances, such as how the security holder transfers ownership and where we make payments. |
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The security holder’s right to receive payment of additional amounts due to changes in the tax withholding requirements of various jurisdictions. |
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The security holder’s rights under several special situations, such as if we merge with another company or if we want to redeem the debt securities for tax reasons. |
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Covenants contained in the indenture that restrict our ability to incur liens and undertake sale and leaseback transactions. A particular series of debt securities may have different covenants. |
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The security holder’s rights if we default. |
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The security holder’s rights if we want to modify the indenture. |
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Our relationship with the trustee. |
Additional Mechanics
Exchange and Transfer
The debt securities will be issued only in fully registered form without interest coupons in denominations of $2,000 or whole multiples of $1,000 in excess thereof. The security holder may have his or her debt securities broken into more debt securities of smaller denominations of whole multiples of $1,000 (but not less than a minimum denomination of $2,000) or combined into fewer debt securities of larger denominations of whole multiples of $1,000, as long as the total principal amount is not changed. This is called an exchange.
The security holder may exchange or transfer registered debt securities at the office of the trustee. The trustee acts as our agent for registering debt securities in the names of holders and for transferring registered debt securities. We may change this appointment to another entity or perform the service ourselves. The entity performing the role of maintaining the list of registered holders is called the security registrar. It will also register transfers of the registered debt securities.
The security holder may not exchange his or her registered debt securities for bearer securities.
There will be no service charge for any exchange or registration of transfer of the debt securities, but we may require payment of an amount sufficient to cover any tax or other governmental charge imposed in connection with any exchange or registration of transfer.
The transfer or exchange of a registered debt security may be made only if the security registrar is satisfied with the security holder’s proof of ownership.
If the debt securities are redeemable and we redeem less than all of the debt securities of a particular series, we may block the transfer or exchange of debt securities during a specified period of time in order to freeze the list of holders to prepare the mailing. The period begins 15 days before the day we first mail the notice of redemption and ends on the day of that mailing. We may also refuse to register transfers or exchanges of debt securities selected or called for redemption. However, we will continue to permit transfers and exchanges of the unredeemed portion of any security being partially redeemed.
Payment and Paying Agents
We will pay interest to the security holder if he or she is a direct holder of debt securities at the close of business on a particular day in advance of each due date for interest, even if the security holder no longer owns the security on the interest due date. That particular day, usually about two weeks in advance of the interest due date, is called the record date and is stated in the prospectus supplement.
Unless otherwise specified in the prospectus supplement, we will pay interest, principal and any other money due on debt securities in registered form at the corporate trust office of The Bank of New York Mellon (as successor paying agent to JPMorgan Chase Bank) in the Borough of Manhattan, The City and State of New York as paying agent for the debt securities. That office is located at The Bank of New York Mellon, 101 Barclay Street, New York, New York 10286. At our option, we may pay interest on any debt securities by check mailed to the registered holders.
Some of the debt securities may be denominated, and payments may be made, in currencies other than US dollars or in composite currencies. A summary of any special considerations which apply to these debt securities is in the applicable prospectus supplement.
Street name and other indirect holders should consult their banks or brokers for information on how they will receive payments.
We may arrange for additional payment offices, or may cancel or change these offices, including our use of the trustee’s corporate trust office. These offices are called paying agents. We may also choose to act as our own paying agent, but must always maintain a paying agency in the Borough of Manhattan, The City and State of New York. Whenever there are changes in the paying agents for any particular series of debt securities we must notify the trustee.
Payment of Additional Amounts
Unless provided otherwise in the applicable prospectus supplement, we agree that any amounts to be paid by us under any series of debt securities of principal, premium and interest in respect of the debt securities will be paid without deduction or withholding for, any and all present and future taxes, levies, duties, assessments, imposts or other governmental charges of whatever nature imposed, assessed, levied or collected by or for the account of the government of any jurisdiction in which we are resident for tax purposes (at the time of the issuance, the UK) or any political subdivision or taxing authority of such jurisdiction, unless such withholding or deduction is required by law. If such deduction or withholding is at any time required, we will (subject to compliance by the security holder with any relevant administrative requirements) pay such additional amounts as will result in the receipt of such amounts as would have been received by the holder had no such withholding or deduction been required.
The indenture provides that we will not have to pay additional amounts in certain specified circumstances, and that those circumstances may be modified or supplemented for different series of debt securities. Unless the prospectus supplement for a series of debt securities provides otherwise, debt securities issued using this prospectus will provide that we will not have to pay additional amounts if:
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the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for the holder’s (or certain related parties’) connection to the jurisdiction in which we are resident for tax purposes, other than by merely holding the debt security or by receiving principal, premium, if any, or interest, if any, on the debt security, or enforcing the debt security. These connections include where the holder or related party: |
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is or has been a domiciliary, national or resident of such jurisdiction; |
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is or has been engaged in a trade or business in such jurisdiction; |
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has or had a permanent establishment in such jurisdiction; or |
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is or has been physically present in such jurisdiction. |
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the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for presentation of the debt security for payment, if presentation is required, more than 30 days after the security became due or payment was provided for; |
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the tax, levy, impost or other governmental charge is an estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge; |
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the tax, levy, impost or other governmental charge is payable in a manner that does not involve deduction or withholding from payments on or in respect of the relevant debt security; |
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the tax, levy, impost or other governmental charge would not have been imposed or withheld but for the failure of the holder or beneficial owner to comply with any certification, identification or other reporting requirement concerning the nationality, residence, identity or connection with any jurisdiction in which we are resident for tax purposes, as required by any treaty, statute, regulation or |
administrative practice of such jurisdiction as a condition to relief or exemption from such tax, levy, impost or other governmental charge;
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the tax, levy, impost or other governmental charge is imposed on a payment to or for an individual and is required to be made pursuant to the European Union Directive 2003/48/EC on the taxation of savings or any other directive implementing the conclusions of the ECOFIN Council meeting of 26-27 November 2000 or any law implementing or complying with, or introduced in order to conform to, such Directive; |
· |
the holder would have been able to avoid such withholding or deduction by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form required by the relevant tax authority, a declarative, claim, certificate, document or other evidence establishing exemption therefrom; |
· |
the tax, levy, impost or other governmental charge is imposed by the United States or any political subdivision or taxing authority thereof or therein; |
· |
the holder would have been able to avoid such withholding or deduction by presenting the relevant debt security to another paying agent in a Member State of the EU or elsewhere; |
· |
the holder of the debt security is a fiduciary, partnership or a person other than the sole beneficial owner of any payment that would be required, by the laws of the jurisdiction in which we are resident for tax purposes, to be included in income, for tax purposes, of a beneficiary or settlor with respect to the fiduciary, a member of that partnership or a beneficial owner who would not have been entitled to the additional amounts had that beneficiary, settlor, partner or beneficial owner been the holder; or |
· |
any combination of the exceptions listed above. |
Mergers and Similar Events
We are generally permitted to consolidate or merge with another company or other entity that is organized under the laws of the United Kingdom, the United States or any other country which is a member of the Organization for Economic Cooperation and Development. We are also generally permitted to sell or convey our property as an entirety or substantially as an entirety to such other entity. Our ability to take some of these actions is restricted in the following ways:
· |
any entity succeeding us must assume our obligations in relation to the debt securities and under the indenture; |
· |
if the succeeding entity is not organized under the laws of the United Kingdom or a State of the United States, the succeeding entity’s assumption of our obligations in relation to the debt securities and under the indenture must include the obligation to pay any additional amounts as described under “- Payment of Additional Amounts”. |
It is possible that the merger, sale, or lease of all or substantially all of our assets would cause a principal property of ours or of a restricted subsidiary of ours or shares of stock or indebtedness of any of our restricted subsidiaries to become subject to a lien giving other lenders preferential rights in that property over holders of debt securities. We have promised to limit these preferential rights on our property, called liens, as discussed under “- Limitation on Liens”. If a merger or other transaction would create any impermissible liens on our property, we must grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
Optional Tax Redemption
We have the option to redeem the debt securities in the two situations described below. The redemption price for the debt securities, other than original issue discount debt securities, will be equal to the principal amount of the debt securities being redeemed plus accrued interest and any additional amounts due on the date fixed for redemption. The redemption price for original issue discount debt securities will be specified in the applicable prospectus supplement. We must give the security holder between 30 and 60 days’ notice before redeeming the debt securities.
The first situation is where, as a result of a change or amendment to any law or related regulation or ruling of the jurisdiction in which we are resident for tax purposes, or any change in an application or interpretation of such laws, regulations or rulings, or any change in application or interpretation of, or any execution of an amendment to, any treaty, we would have to pay additional amounts as described under “- Payment of Additional Amounts”.
This first situation applies only in the case of changes, amendments, applications, interpretations or executions that occur on or after the date specified in the prospectus supplement for the applicable series of debt securities. If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes, and the applicable date will be the date such entity became successor, rather than the date specified in the prospectus supplement.
The second situation is where our independent legal adviser has advised us that, as a result of action taken by a taxation authority of, or any action brought in a court of competent jurisdiction in, the jurisdiction in which we are resident for tax purposes, after the date specified in the prospectus supplement for the applicable series of debt securities, we would have to pay additional amounts as described under “- Payment of Additional Amounts” and the payment of such additional amounts cannot be avoided by the use of reasonable measures available to us. If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes and the applicable date will be the date such entity became our successor.
Covenants
Limitation on Liens
Some of our property and the property of our subsidiaries may be subject to a mortgage, pledge, assignment, charge or other legal mechanism that gives a lender preferential rights in that property over other lenders, including the security holder and the other direct holders of the debt securities, or over our general creditors if we fail to repay them. These preferential rights are generally called liens.
We undertake that we and certain of our subsidiaries, which we refer to as “restricted subsidiaries”, will not become obligated on any new debt for borrowed money that is secured by a lien on any principal property or on any shares of stock or indebtedness of any of our restricted subsidiaries unless we grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
· |
Restricted subsidiary means any wholly-owned subsidiary: |
· |
with substantially all of its property located within the UK or the US; and |
· |
which owns a principal property; |
but does not include any wholly-owned subsidiary principally engaged in leasing or in financing installment receivables or principally engaged in financing the operations of us and our consolidated subsidiaries.
· |
A wholly-owned subsidiary means any corporation in which control, directly or indirectly, of all of the stock with ordinary voting power to elect the board of directors of that corporation is owned by us, or by one or more of our wholly-owned subsidiaries or by us and one or more of our wholly-owned subsidiaries. |
· |
A subsidiary, with respect to any person, is any corporation in which that person owns or controls directly or indirectly at least a majority of stock with ordinary voting power to elect a majority of the board of directors. |
· |
Principal property means any manufacturing plant or facility or any research facility owned by us or any restricted subsidiary. A principal property must also be located within the UK or the US and have a gross book value (before deducting any depreciation reserve) exceeding 2% of our consolidated net tangible assets. Principal property does not include: |
· |
any plant or facility or research facility which in the opinion of our board of directors is not materially important to the total business conducted by us and our subsidiaries; or |
· |
any portion of a property described above which, in the opinion of our board of directors, is not materially important to the use or operation of the property. |
We do not need to comply with this restriction if the amount of all debt that would be secured by liens on our principal properties and the shares of stock or indebtedness of our restricted subsidiaries is no more than 15% of our consolidated net tangible assets.
· |
Our consolidated net tangible assets mean AstraZeneca PLC’s consolidated total assets, after deducting: |
· |
all liabilities due within one year (other than short-term borrowings and long-term debt due within one year); and |
· |
all goodwill, trade names, trademarks, patents and other similar types of intangible assets as shown on the audited consolidated balance sheet contained in the latest annual report to our shareholders. |
This restriction on liens does not apply to debt secured by a number of different types of liens. These types of liens include the following:
· |
any lien on property, shares of stock or indebtedness of any corporation existing at the time the corporation becomes a restricted subsidiary; |
· |
any lien on property or shares of stock existing at the time of acquisition of that property or those shares of stock, or to secure the payment of all or any part of the purchase price of that property or those shares of stock, or to secure any debt incurred before, at the time of, or within twelve months after, in the case of shares of stock, the acquisition of the shares of stock and, in the case of property, the later of the acquisition, completion of construction (including any improvements on an existing property) or commencement of the commercial operation of the property, where the debt is incurred to finance all or any part of the purchase price; |
· |
any lien securing debt owed to us or to any of our restricted subsidiaries by us or any of our restricted subsidiaries; |
· |
any lien existing at the date of the indenture; |
· |
any lien on a principal property to secure debt incurred to finance all or part of the cost of improving, constructing, altering or repairing any building, equipment or facilities or of any other improvements on all or any part of that principal property, if the debt is incurred before, during, or within twelve months after completing the improvement, construction, alteration or repair; |
· |
any lien on property owned or held by any corporation or on shares of stock or indebtedness of any corporation, where the lien existed either at the time the corporation is merged, consolidated or amalgamated with either us or a restricted subsidiary or at the time of a sale, lease or other disposition of all or substantially all of the property of a corporation to us or a restricted subsidiary; |
· |
any lien arising by operation of law and not securing amounts more than 90 days overdue or otherwise being contested in good faith; |
· |
any lien arising by operation of law over any credit balance or cash held in any account with a financial institution; |
· |
any rights of financial institutions to offset credit balances in connection with the operation of cash management programs established for our benefit and/or the benefit of any restricted subsidiary; |
· |
any lien incurred or deposits made in the ordinary course of business, including but not limited to: |
· |
any mechanics’, materialmen’s, carriers’, workmen’s, vendors’ or other similar liens; |
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any liens securing amounts in connection with workers’ compensation, unemployment insurance and other types of social security; and |
· |
any easements, rights-of-way, restrictions and other similar charges; |
· |
any liens incurred or deposits made securing the performance of tenders, bids, leases, statutory obligations, surety and appeal bonds, government contracts, performance and return of money bonds and other obligations of a similar nature incurred in the ordinary course of business; |
· |
any lien securing taxes or assessments or other applicable governmental charges or levies; |
· |
any extension, renewal or replacement or successive extensions, renewals or replacements, in whole or in part, of any lien included in the preceding paragraphs or of any of the debt secured under the preceding paragraphs, so long as the principal amount of debt secured does not exceed the principal amount of debt secured at the time of the extension, renewal or replacement, and that the extension, renewal or replacement lien is limited to all or any part of the same property or shares of stock that secured the lien extended, renewed or replaced (including improvements on that property), or property received or shares of stock issued in substitution or exchange; and |
· |
any lien in favor of us or any subsidiary of ours. |
The following types of transactions will not be deemed to create debt secured by a lien and, therefore, will also not be subject to the restriction on liens:
· |
any liens on property of ours or a restricted subsidiary in favor of the US or any State of the US, or the UK, or any other country, or any political subdivision of, or any department, agency or instrumentality of, these countries or states, to secure partial, progress, advance or other payments under provisions of any contract or statute including, but not limited to, liens to secure debt of pollution control or industrial revenue bond type, or to secure any indebtedness incurred for the purpose of financing all or any part of the purchase price or cost of construction of the property subject to these liens. |
Limitation on Sale and Lease-Back Transactions
Neither we nor any of our restricted subsidiaries will enter into any sale and lease-back transaction involving a principal property without complying with this covenant.
A sale and lease-back transaction is an arrangement between us or a restricted subsidiary and any person in which we or the restricted subsidiary leases back for a term of more than three years a principal property that we or the restricted subsidiary has sold or transferred to that person.
We and our restricted subsidiaries may enter into sale and lease-back transactions provided that the total amount of attributable debt attributable to all sale and lease-back transactions plus other debt of ours or any of our restricted subsidiaries that is secured by liens (but excluding debt secured by liens on property that we or a restricted subsidiary would be entitled to incur, assume or guarantee without equally and ratably securing the debt securities offered by this prospectus as described under “- Limitation on Liens” above) does not exceed 15% of consolidated net tangible assets.
This restriction does not apply to any sale and lease-back transaction if:
· |
we or the restricted subsidiary seeking to enter into the sale and lease-back could incur, assume or guarantee debt secured by a lien on the principal property to be leased without equally and ratably securing the debt securities offered by this prospectus as a result of one or more of the exceptions to the limitation on liens as described under “- Limitation on Liens” above; |
· |
within twelve months before or after the sale or transfer, regardless of whether the sale or transfer may have been made by us or a restricted subsidiary, we apply, an amount equal to the net proceeds of the sale or transfer (in the case of a sale or transfer for cash), or an amount equal to the fair value of the |
principal property so leased at the time of entering into the sale or transfer as determined by our board of directors (in the case of a sale or transfer otherwise than for cash), to
· |
the retirement of indebtedness for money borrowed, incurred or assumed by us or any restricted subsidiary which matures at, or is extendible or renewable at the option of the obligor to, a date more than twelve months after the date of incurring, assuming or guaranteeing such debt, or |
· |
investment in any principal property or principal properties. |
This restriction on sale and lease-back transactions also does not apply to any transaction between us and a restricted subsidiary, or between restricted subsidiaries.
Attributable debt means the present value (discounted at a rate equal to the weighted average of the rate of interest on all securities then issued and outstanding under the indenture, compounded semi-annually) of our or a restricted subsidiary’s obligation for rental payments for the remaining term of any lease in a sale and lease-back transaction.
Default and Related Matters
Events of Default
A holder of debt securities of a particular series will have special rights if any event of default occurs with respect to that series and is not cured, as described later in this subsection.
What is an event of default? An event of default means any of the following:
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Interest - default for 30 days in the payment of any installment of interest on the series of debt securities; |
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Principal - default in the payment of all or any part of the principal of the series of debt securities when such principal becomes due and payable either at maturity, upon redemption, by acceleration or otherwise; |
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Sinking Fund Installment - default in the payment of any sinking fund installment as and when such installment becomes due and payable by the specific terms of the series of debt securities or beyond any period of grace; |
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Covenant - breach or default by us in the performance of a covenant or warranty in respect of the debt securities of the relevant series which has not been remedied for ninety days after we receive written notice of the default from the trustee or we and the trustee receive written notice of the default from the holders of at least 25% of the principal amount of the debt securities of all affected series; |
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Bankruptcy - certain events of bankruptcy, insolvency or reorganization affecting us; or |
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Other - any other event of default provided in any supplemental indenture or resolution of our board of directors under which a particular series is issued or in the form of security for such series. |
No event of default described in the provisions above with respect to a particular series of debt securities will necessarily constitute an event of default with respect to any other series of debt securities and the events of default for any specific series may be modified as described in the applicable prospectus supplement.
Remedies if an event of default occurs. If an event of default, other than a “Bankruptcy” default, has occurred (but only if, in the case of a “Covenant” default, the default has occurred for less than all series of debt securities then issued under the indenture and outstanding) and has not been cured, the trustee or the holders of at least 25% of the principal amount of debt securities of the affected series (each affected series voting as a separate class) may declare the principal amount (or, if the debt securities of a series are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all the debt securities of that series, together with any accrued interest, to be due and payable immediately.
If an event of default has occurred under “Covenant” default with respect to all of the series of debt securities then issued under the indenture and outstanding, or under “Bankruptcy” default, and has not been cured, the trustee or the holders of at least 25% of the principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class) may declare the principal (or, if any debt securities are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all debt securities then issued under the indenture and outstanding, together with any accrued interest, to be due and payable immediately. This is called a declaration of acceleration of maturity. A declaration of acceleration of maturity may be canceled by the holders of at least a majority in principal amount of the debt securities of the affected series or by at least a majority in principal amount of all the debt securities then issued under the indenture and outstanding (voting as one class), as the case may be, if certain conditions are met.
Before a declaration of acceleration of maturity, past “Covenant” defaults that do not affect all series of debt securities then issued under the indenture and outstanding may be waived by the holders of a majority in principal amount of the debt securities then outstanding of each affected series (each such series voting as a separate class). Past “Covenant” defaults that affect all series of debt securities then issued under the indenture and outstanding and past “Bankruptcy” defaults may be waived by the holders of a majority in principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class). Default in the payment of principal of or interest on or any sinking fund installment of debt securities of any series or a covenant or provision of the indenture that cannot be modified or amended without the consent of the holder of each debt security affected may only be modified or amended with the consent of such holder.
Except in cases of default, where the trustee has some special duties, the trustee is not required to take any action under the indenture at the request of any holders unless the holders offer the trustee reasonable protection from expenses and liability. This protection is called an indemnity. If reasonable indemnity is provided, the holders of a majority in principal amount of the outstanding debt securities of the relevant series may, subject to certain limitations and conditions, direct the time, method and place of conducting any lawsuit or other formal legal action seeking any remedy available to the trustee. These majority holders may also, subject to certain limitations and conditions, direct the trustee in performing any other action under the indenture.
Before the security holder bypasses the trustee and brings his or her own lawsuit or other formal legal action or takes other steps to enforce his or her rights or protects his or her interests relating to the debt securities, the following must occur:
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the security holder must give the trustee written notice that an event of default has occurred and remains uncured; |
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the holders of 25% in principal amount of all outstanding debt securities of the relevant series must make a written request that the trustee take action because of the default, and must offer reasonable indemnity to the trustee against the cost and other liabilities of taking that action; and |
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the trustee must have not taken action for 60 days after receipt of the above notice and offer of indemnity and the trustee has not received an inconsistent direction from the holders of a majority in principal amount of all outstanding debt securities of the relevant series during that period. |
These limitations do not apply to a suit instituted by the security holder for the enforcement of payment of the principal or interest on a debt security on or after the respective due dates.
We will file annually with the trustee on or before March 31 in each year a written statement of certain of our officers certifying that, to their knowledge, we have not defaulted on our covenants under the indenture or else specifying any default that exists.
For any series of debt securities that is a series of original issue discount securities the prospectus supplement will contain provisions for the acceleration of the maturity of a portion of the principal amount of such original issue discount securities.
Modification of the Indenture and Waiver
There are three types of changes we can make to the indenture and any series of the debt securities.
Changes not requiring approval. The first type of change does not require any vote by holders of debt securities. The security holder’s consent is not required to do any of the following:
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to transfer or pledge any property or assets to the trustee as security for any series of the debt securities; |
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to evidence the succession of any successor corporation to us as described under “Mergers and Similar Events” above; |
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to evidence the succession of any successor trustee under the indenture or to add to or change any provisions of the indenture as necessary to provide for the appointment of an additional trustee or trustees; |
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to add to our covenants or to add additional events of default for the benefit of the holders of any series of the debt securities; |
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to cure any ambiguity or to correct or supplement any provision of the indenture that may be defective or inconsistent with any other provision of the indenture; or |
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to make any other provisions with respect to matters or questions arising under the indenture as our board of directors may deem necessary or desirable and that shall not adversely affect the interests of holders of any series of the debt securities in any material respect. |
Changes requiring the approval of a majority of holders. The second type of change to the indenture and the debt securities requires a vote in favor by holders of debt securities owning at least a majority of the principal amount of all series of debt securities then outstanding and affected by such charge (each affected series voting as a separate class). In this manner, any provision of the indenture or any series of debt securities may be changed or eliminated unless the provision relates to a matter that requires the consent of each affected holder as discussed below.
Changes requiring the security holder’s approval. Third, there are changes that cannot be made to the security holder’s debt securities without the specific approval of each affected holder. The security holder’s consent is required before we could do any of the following:
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extend the final maturity of a debt security; |
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reduce the principal amount of a debt security; |
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reduce the rate or extend the time of payment of any interest on a debt security; |
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reduce any amount payable on redemption of a debt security; |
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reduce the amount of principal due and payable upon an acceleration of the maturity or provable in bankruptcy of a debt security issued at an original issue discount; |
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impair the security holder’s right to sue for payment; |
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impair any right of repayment at the option of the holder; |
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reduce the percentage of holders of debt securities whose consent is needed to modify or amend the indenture; or |
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change in any manner adverse to the holders of the debt securities our obligations relating to the payment of principal and interest, and sinking fund payments. |
Satisfaction, Discharge and Defeasance
We may terminate our repayment and obligations on the debt securities, when:
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we have paid or caused to be paid the principal of and interest, if any, then due and payable on all outstanding debt securities of any series; or |
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we have delivered to the trustee for cancellation all outstanding debt securities of any series; or |
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all the outstanding debt securities of the series that have not been delivered to the trustee for cancellation have become or will become due and payable within one year and we have made arrangements satisfactory to the trustee for the giving of notice of redemption by the trustee in our name; and |
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we have deposited with the trustee sufficient funds to pay and discharge the entire indebtedness on the series of debt securities to pay principal and interest, if any, and paid all other sums payable under the indenture. |
We may legally release ourselves from any payment or other obligations on the debt securities, except for various obligations described below, if we, in addition to other actions, put in place the following arrangements for the security holder:
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we must deposit in trust for the security holder’s benefit and the benefit of all other direct holders of the debt securities a combination of money and government obligations that will generate enough cash to make interest, principal and any other payments on the debt securities on their various due dates; and |
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we must deliver to the trustee a legal opinion of our counsel to the effect that the holders of the debt securities of that series will not recognize gain or loss for US federal income tax purposes as a result of the defeasance and will be subject to the same federal income tax as would be the case if the defeasance did not occur. |
However, even if we take these actions, a number of our obligations relating to the debt securities will remain. These include the following obligations:
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to register the transfer and exchange of debt securities and our right of optional redemption, if any; |
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to replace mutilated, defaced, destroyed, lost or stolen debt securities; |
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to pay principal and interest, if any, on the original stated due dates and any remaining rights of the holders to receive sinking fund payments, if any, from funds deposited with the trustee; |
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immunities of the trustee; and |
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to hold money for payment in trust. |
Government obligation means securities that are:
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direct obligations of the US or any foreign government of a sovereign state for the payment of which is pledged by the full faith and credit of the US or such foreign government; or |
· |
obligations of an entity controlled or supervised by and acting as an agency or instrumentality of the US or any foreign government of a sovereign state the payment of which is unconditionally guaranteed as a full faith and credit obligation of the US or such foreign government; |
and are not callable or redeemable at the option of the issuer. Government obligation also includes:
· |
a depositary receipt issued by a bank or trust company as custodian for these government obligations, or specific payment of interest on or principal of these government obligations, held by such custodian for the account of the holder of a depositary receipt, provided that (except as required by law) such custodian is not authorized to make any deductions from the amount payable to the holder of such depositary receipt from any amount received by the custodian in respect of these government obligations, or the specific payment of interest on or principal of these government obligations, evidenced by such depositary receipt. |
Notices
We and the trustee will send notices only to direct holders, using their addresses registered in the trustee’s records.
Regardless of who acts as paying agent, all money that we pay to a paying agent that remains unclaimed at the end of two years after the amount is due to direct holders of debt securities will be repaid to us. After that two-year period, the security holder may look only to us for payment and not to the trustee, any other paying agent or anyone else.
Governing Law
The debt securities and the indenture will be governed by and construed in accordance with the laws of the State of New York.
Concerning the Trustee
The Bank of New York Mellon acts as the trustee with respect to certain debt securities of certain of our subsidiaries.
If an event of default occurs, or an event occurs that would be an event of default if the requirements for either giving us notice or our default having to exist for a specified time period were disregarded, the trustee may be considered to have a conflicting interest with respect to the debt securities or the indenture for purposes of the Trust Indenture Act of 1939. In that case, the trustee may be required to resign as trustee under the applicable indenture and we would be required to appoint a successor trustee.
D. |
0.700% Notes due 2026, 1.375% Notes due 2030 and 2.125% Notes due 2050 |
Prospectus Supplement:
DESCRIPTION OF NOTES
General
We offered $1,200,000,000 initial aggregate principal amount of 0.700% Notes due 2026 (the “2026 Notes”), $1,300,000,000 initial aggregate principal amount of 1.375% Notes due 2030 (the “2030 Notes”) and $500,000,000 initial aggregate principal amount of 2.125% Notes due 20150 (the “2050 Notes”, and together with the 2026 Notes and the 2030 Notes, the “Notes”). The notes are governed by New York law.
The Notes are unsecured, unsubordinated indebtedness of AstraZeneca PLC and rank equally with all of AstraZeneca PLC’s other unsecured and unsubordinated indebtedness from time to time outstanding.
There is no sinking fund for any series of Notes. We have listed the Notes on the Nasdaq Stock Market LLC.
Interest Payments and Maturity
For purposes of the description below, “business day” means any day which is not, in London, England or New York, New York, or the place of payment of amounts payable in respect of the Notes, a Saturday, a Sunday, a legal holiday or a day on which banking institutions are authorized or obligated by law, regulation or executive order to close. A “London business day” is a day on which dealings in deposits in U.S. dollars are transacted in the London interbank market.
Fixed Rate Notes
Maturity. The aggregate principal amounts of the 2026 Notes, the 2030 Notes and the 2050 Notes will mature and become due and payable, together with any accrued and unpaid interest, on April 8, 2026, August 6, 2030 and August 6, 2050, respectively.
Interest Rate. Each of the 2026 Notes, the 2030 Notes and the 2050 Notes will bear interest from their respective original issue dates until their principal amount is paid or made available for payment, at a rate equal to 0.700%, 1.375% and 2.125%, per annum, respectively, calculated on the basis of a 360-day year and twelve 30-day months.
Interest Payment Dates. Interest on the 2026 Notes will be paid semi-annually in arrears on April 8 and October 8 of each year, commencing April 8, 2021 (each a “2026 Interest Payment Date”). Interest on the 2030 Notes and the 2050 Notes will be paid semi-annually in arrears on February 6 and August 6 of each year, commencing February 6, 2021 (together with each 2026 Interest Payment Date, each an “Interest Payment Date”). However, if an Interest Payment Date would fall on a day that is not a business day, the Interest Payment Date will be postponed to the next succeeding day that is a business day, but no additional interest shall be paid unless we fail to make payment on such date.
Interest Periods. The first interest period for the Notes will be the period from and including the Issue date to but excluding the first Interest Payment Date. Thereafter, the interest periods for the Notes will be the periods from and including the Interest Payment Dates to but excluding the immediately succeeding Interest Payment Date (together with the first interest period, each an “Interest Period”). The final Interest Period will be the period from and including the Interest Payment Date immediately preceding the maturity date to the maturity date.
Redemption
As explained below, under certain circumstances we may redeem the notes before they mature. This means that we may repay them prior to maturity. The security holder has no right to require us to redeem the Notes. Each series of Notes will stop bearing interest on the applicable redemption date, even if the security holder does not collect his or her money. We will give notice of any redemption we propose to make to DTC at least 15 days, but no more than 60 days, before the applicable redemption date. Notice by DTC to its participants and by these participants to street name holders of indirect interests in the notes will be made according to arrangements among them and may be subject to statutory or regulatory requirements.
Optional Redemption
We may redeem the Notes of any series, in whole or in part, from time to time as follows: (i) prior to the applicable Par Call Date (as set forth below), at a redemption price equal to the greater of (A) 100% of the principal amount of the Notes to be redeemed, and (B) as determined by the Quotation Agent, the sum of the present values of the remaining scheduled payments of principal and interest on the Notes to be redeemed (assuming for this purpose that such series of Notes matured on the applicable Par Call Date and not including any portion of such payments of interest accrued as of the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the treasury rate plus the applicable Make-Whole Spread (as set forth below) and (ii) on or after the applicable Par Call Date, at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus, in each case, accrued interest thereon to but excluding the date of redemption.
In connection with such optional redemption, the following defined terms apply:
· |
“Comparable treasury issue” means the United States Treasury security selected by the Quotation Agent as having an actual or interpolated maturity comparable to the remaining term of the applicable series of Notes to be redeemed that would be utilized, at the time of selection and in accordance with customary financial practice, in pricing new issues of corporate debt securities of comparable maturity to the remaining term of such series of Notes (assuming for this purpose that such series of Notes matured on the applicable Par Call Date). |
· |
“Comparable treasury price” means, with respect to any redemption date, (i) the average, as determined by the Quotation Agent, of the reference treasury dealer quotations for such redemption date, after excluding the highest and lowest such reference treasury dealer quotations, or (ii) if the Quotation Agent obtains fewer than three such reference treasury dealer quotations, the average of all such quotations. |
· |
“Make-Whole Spread” means, with respect to (i) the 2026 Notes, 10 basis points, (ii) the 2030 Notes, 15 basis points and (iii) the 2050 Notes, 15 basis points. |
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“Par Call Date” means, with respect to (i) the 2026 Notes, March 8, 2026, (ii) the 2030 Notes, May 6, 2030 and (iii) the 2050 Notes, February 6, 2050. |
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“Quotation Agent” means the reference treasury dealer appointed by us. |
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“Reference treasury dealer” means (i) each of BofA Securities, Inc., HSBC Securities (USA) Inc. and Mizuho Securities USA LLC and their respective successors or affiliates; provided, however, that if the foregoing shall cease to be a primary US government securities dealer in New York City (a “primary treasury dealer”), we shall substitute therefor another primary treasury dealer; and (ii) any other primary treasury dealer selected by us. |
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“Reference treasury dealer quotations” means, with respect to each reference treasury dealer and any redemption date, the average, as determined by the Quotation Agent, of the bid and asked prices for the comparable treasury issue (expressed in each case as a percentage of its principal amount) quoted in writing to the Quotation Agent by such Reference Treasury Dealer at 3:30 p.m., Eastern Time, on the third business day preceding such redemption date. |
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“Treasury rate” means, with respect to any redemption date, the rate per annum equal to the semi-annual equivalent yield to maturity of the comparable treasury issue, assuming a price for the comparable treasury issue (expressed as a percentage of its principal amount) equal to the comparable treasury price for such redemption date. |
Optional Tax Redemption
In the event of various tax law changes and other limited circumstances that, in each case, occur after the date of this prospectus supplement and require us to pay additional amounts, as described below under “— Payment of Additional Amounts”, we may redeem all, but not less than all, of the Notes of any series at a price equal to 100% of the principal amount of such series of Notes plus accrued interest thereon to but excluding the date of redemption. This means we may repay any one or each series of Notes prior to maturity. We discuss our ability to redeem the Notes in greater detail under “Description of Debt Securities — Optional Tax Redemption” in the accompanying prospectus.
Further Issuances
We may, at our option, at any time and without the consent of the then existing noteholders, reopen any series of Notes and issue additional Notes in one or more transactions after the date of this prospectus supplement with terms (other than the issuance date and, possibly, first interest payment date, original interest accrual date and issue price) identical to such series of Notes issued hereby. These additional Notes will be deemed to have been part of the applicable series of Notes offered hereby and will provide the holders of these additional Notes the right to vote together with holders of the applicable series of Notes issued hereby; provided, however, that if these additional Notes are not fungible with the applicable series of Notes offered hereby for U.S. federal income tax purposes, these additional Notes will have a different CUSIP or other identifying number.
Form, Denomination, Clearance and Settlement
We will issue the Notes in fully registered form. Each series of Notes will be represented by one or more global securities registered in the name of a nominee of DTC. The security holder will hold beneficial interests in the Notes through DTC in book-entry form. The Notes will be issued in minimum denominations of $2,000 and in integral multiples of $1,000 in excess thereof. The underwriters expect to deliver the Notes through the facilities of DTC on August 6, 2020. Indirect holders trading their beneficial interests in the Notes through DTC must trade in DTC’s same-day funds settlement system and pay in immediately available funds. Secondary market trading through Euroclear and Clearstream, Luxembourg will occur in the ordinary way following the applicable rules and operating procedures of Euroclear and Clearstream, Luxembourg.
Payment of principal of and interest on each series of Notes, so long as the Notes are represented by global securities, as discussed below, will be made in immediately available funds. Beneficial interests in the global securities will trade in the same-day funds settlement system of DTC, and secondary market trading activity in such interests will therefore settle in same-day funds.
Payment of Additional Amounts
We agree that any amounts to be paid by us under the Notes of principal, premium and interest in respect of the Notes will be paid without deduction or withholding for, any and all present and future taxes, levies, duties, assessments, imposts or other governmental charges of whatever nature imposed, assessed, levied or collected by or for the account of the government of any jurisdiction in which we are resident for tax purposes (at the time of the issuance, the UK) or any political subdivision or taxing authority of such jurisdiction, unless such withholding or deduction is required by law. If such deduction or withholding is at any time required, we will pay such additional amounts as will result in the receipt of such amounts as would have been received by the holder had no such withholding or deduction been required, provided that we will not have to pay additional amounts if:
(i) the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for the holder’s (or certain beneficial owners’) connection to the jurisdiction in which we are resident for tax purposes, other than by merely holding the Note or by receiving principal, premium, if any, or interest, if any, on the Note, or enforcing the Note. These connections include where the holder or beneficial owner:
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is or has been a domiciliary, national or resident of such jurisdiction; |
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is or has been engaged in a trade or business in such jurisdiction; |
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has or had a permanent establishment in such jurisdiction; or |
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is or has been physically present in such jurisdiction; |
(ii) the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for presentation of the Note for payment, if presentation is required, more than 30 days after the Note became due or payment was provided for;
(iii) the tax, levy, impost or other governmental charge is an estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge;
(iv) the tax, levy, impost or other governmental charge is payable in a manner that does not involve deduction or withholding from payments on or in respect of the relevant Note;
(v) the tax, levy, impost or other governmental charge would not have been imposed or withheld but for the failure of the holder or beneficial owner, upon a reasonable request, addressed to the holder, to comply with any certification, identification or other reporting requirement, concerning the holder’s or the beneficial owner’s nationality, residence, identity or connection with any jurisdiction in which we are resident for tax purposes, if compliance is required by any treaty, statute, regulation or administrative practice of such jurisdiction as a condition to relief or exemption from such tax, levy, impost or other governmental charge;
(vi) the tax, levy, impost or other governmental charge is required by Sections 1471 through 1474 of the Internal Revenue Code of 1986, as amended (“FATCA”), any current or future U.S. Treasury Regulations or rulings promulgated thereunder, any intergovernmental agreement between the United States and any other jurisdiction to implement FATCA (an “IGA”), any law, regulation or other official guidance enacted in any jurisdiction implementing FATCA or an IGA, or any agreement with the U.S. Internal Revenue Service under or with respect to FATCA; or
(vii) any combination of the taxes referred to in (i) through (vi) above.
In addition, no payments of additional amounts will be made with respect to any payment on a Note if the holder of the Note is a fiduciary, partnership or a person other than the sole beneficial owner of any payment, and, by the laws of the jurisdiction in which we are resident for tax purposes, that payment would be required for tax purposes to be included in income of a beneficiary or settlor with respect to the fiduciary, a member of that partnership or a beneficial owner who would not have been entitled to the additional amounts had that beneficiary, settlor, member or beneficial owner been the holder of the relevant Note.
We will remit the full amount of any taxes withheld to the applicable taxing authorities in accordance with the applicable law. We will also provide the trustee with documentation reasonably satisfactory to the trustee evidencing the payment of any taxes in respect of which we have paid additional amounts. We will provide copies of such documentation to the holders of the Notes upon request.
Any reference in this prospectus supplement, the Indenture or the Notes to principal, premium or interest in respect of the Notes will be deemed also to refer to any additional amounts that may be payable with respect to such principal, premium or interest under the obligations referred to in this subsection.
Defeasance and Discharge
We may release ourselves from any payment or other obligations on each series of Notes as described under “Description of Debt Securities — Satisfaction, Discharge and Defeasance” in the Base Prospectus.
Paying Agent
The principal corporate trust office of the trustee in The City of New York is designated as the principal paying agent. See “— Trustee” immediately below. We may at any time designate additional paying agents or rescind the designation of paying agents or approve a change in the office through which any paying agent acts.
Trustee
The Bank of New York Mellon is the trustee under the Indenture. The trustee’s address is The Bank of New York Mellon, Corporate Trust Office, 240 Greenwich Street, New York, NY 10286. The trustee will also serve as the paying agent for the Notes. See “— Paying Agent” immediately above.
See “Description of Debt Securities — Concerning the Trustee” and “Description of Debt Securities — Default and Related Matters” in the Base Prospectus below for a description of the trustee’s procedures and remedies available in the event of default.
Base Prospectus:
DESCRIPTION OF DEBT SECURITIES
We may issue debt securities using this prospectus. As required by US federal law for all publicly offered corporate bonds and notes, the debt securities are governed by a document called an indenture. The indenture relating to the debt securities issued by us is a contract, dated as of April 1, 2004, between AstraZeneca PLC and JPMorgan Chase Bank, as trustee. As a result of the transfer of JPMorgan Chase Bank’s corporate trust business to The Bank of New York Mellon effective October 1, 2006, The Bank of New York Mellon is the trustee under the indenture. See “— The Trustee” below.
In this description “the security holder” means direct holders and not street name or other indirect holders of securities. Indirect holders should read the section “Legal Ownership — Street Names and Other Indirect Holders” in the Base Prospectus.
General
This section summarizes the material provisions of the indenture and the debt securities. Because it is a summary, it does not describe every aspect of the indenture or the debt securities. This summary is subject to and qualified in its entirety by reference to all of the indenture provisions, including some of the terms used and defined in the indenture. We describe the meaning of only the more important terms in this prospectus. We also include references in parentheses to some sections of the indenture. Whenever we refer to particular sections or defined terms of the indenture in this prospectus or in the applicable prospectus supplement, those sections or defined terms are incorporated by reference here or in the prospectus supplement. This summary is also subject to and qualified by reference to the description of the particular terms of the security holder’s series of debt securities described in the prospectus supplement.
The indenture and its associated documents contain the full legal text of the matters described in this section. The indenture and the debt securities are governed by New York law. The indenture is an exhibit incorporated by reference into this prospectus.
The debt securities are unsecured obligations of AstraZeneca PLC. The debt securities will rank equally in right of payment with all of our other unsecured and unsubordinated indebtedness except for indebtedness that is preferred under applicable law.
The Trustee
The Bank of New York Mellon (as successor trustee to JPMorgan Chase Bank) is the trustee under the indenture. As trustee, it has two main roles:
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first, it can enforce the security holder’s rights against us if we default on debt securities issued under the indenture. There are some limitations on the extent to which the trustee may act on the security holder’s behalf, described under “Defaults and Related Matters — Remedies if an event of default occurs” below; and |
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second, the trustee performs administrative duties for us, such as sending the security holder interest payments and notices. |
Types of Debt Securities
The indenture does not limit the amount of debt securities that we can issue. It provides that debt securities may be issued in one or more series up to the aggregate principal amount as we authorize from time to time. All debt securities of one series need not be issued at the same time and we may reopen any series, without the consent of a holder of that series, to issue additional debt securities of the same series.
The prospectus supplement relating to a series of debt securities will describe the following terms of the series:
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the title of the series of debt securities; |
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the aggregate principal amount of debt securities and any limit on the aggregate principal amount of the series of debt securities; |
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any stock exchange on which we will list the debt securities; |
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the date or dates on which we will repay the principal amount of the series of debt securities or the method by which the date or dates will be determined; |
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any rate or rates at which the series of debt securities will bear interest or the method by which the interest rate or rates will be determined; |
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the date or dates from which any interest on the series of debt securities will accrue, the dates on which interest will be payable and the record dates for interest payments or the method by which such date or dates will be determined and the method by which interest will be calculated if different to a 360-day year of twelve 30-day months; |
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the place or places where the principal and any interest on debt securities will be payable if other than the corporate trust office of the trustee in New York, New York; |
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the price or prices at which, the period or periods within which, the currency or currencies, currency unit or composite currency in which, and the terms and conditions upon which we may redeem the series of debt securities in whole or in part; |
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any right or obligation to redeem, repay or purchase the debt securities as a result of any sinking fund or similar provisions, or at the option of the holder of the debt securities and the period or periods within which, the price or prices at which and every other term and condition upon which the debt securities will be redeemed, repaid or purchased; |
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the denominations in which debt securities of the series are issuable, if other than denominations of $2,000 and any whole multiple of $1,000 in excess thereof; |
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the portion of the principal amount of the series of debt securities payable if an acceleration of the maturity of the debt securities is declared, if other than the principal amount; |
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the currency, including any composite currency, of payment of the principal, premium, if any, and interest on the series of debt securities if other than US dollars; |
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whether we or a holder of debt securities may elect to have the principal, premium, if any, or interest on the series of debt securities paid in a currency or composite currency other than the currency in which the debt securities are stated to be payable, and if so, any election period and the terms and conditions governing such an election; |
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whether we will be required to pay additional amounts for withholding taxes or other governmental charges and, if applicable, a related right to an optional tax redemption for such a series; |
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any index used to determine the amount of payment of principal, premium, if any, and interest on the series of debt securities and how these amounts will be determined if they are not fixed when the debt securities are issued; |
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the forms of the series of debt securities; |
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the applicability of the provisions described later under “— Satisfaction, Discharge and Defeasance”; |
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any authenticating or paying agents, transfer agents or registrars or any other agents acting in connection with the debt securities other than the trustee; |
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if applicable, a discussion of any additional or alternative material US federal income and UK tax considerations; and |
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any other special features of the series of debt securities. |
We may issue the debt securities as original issue discount securities, which are debt securities offered and sold at a substantial discount to their stated principal amount.
Overview of the Remainder of this Description
The remainder of this description summarizes:
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Additional mechanics relevant to the debt securities under normal circumstances, such as how the security holder transfers ownership and where we make payments. |
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The security holder’s right to receive payment of additional amounts due to changes in the tax withholding requirements of various jurisdictions. |
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The security holder’s rights under several special situations, such as if we merge with another company or if we want to redeem the debt securities for tax reasons. |
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Covenants contained in the indenture that restrict our ability to incur liens and undertake sale and leaseback transactions. A particular series of debt securities may have different covenants. |
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The security holder’s rights if we default. |
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The security holder’s rights if we want to modify the indenture. |
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Our relationship with the trustee. |
Additional Mechanics
Exchange and Transfer
The debt securities will be issued only in fully registered form without interest coupons in denominations of $2,000 or whole multiples of $1,000 in excess thereof. The security holder may have his or her debt securities broken into more debt securities of smaller denominations of whole multiples of $1,000 (but not less than a minimum denomination of $2,000) or combined into fewer debt securities of larger denominations of whole multiples of $1,000, as long as the total principal amount is not changed. This is called an exchange.
The security holder may exchange or transfer registered debt securities at the office of the trustee. The trustee acts as our agent for registering debt securities in the names of holders and for transferring registered debt securities. We may change this appointment to another entity or perform the service ourselves. The entity performing the role of maintaining the list of registered holders is called the security registrar. It will also register transfers of the registered debt securities.
The security holder may not exchange his or her registered debt securities for bearer securities.
There will be no service charge for any exchange or registration of transfer of the debt securities, but we may require payment of an amount sufficient to cover any tax or other governmental charge imposed in connection with any exchange or registration of transfer.
The transfer or exchange of a registered debt security may be made only if the security registrar is satisfied with the security holder’s proof of ownership.
If the debt securities are redeemable and we redeem less than all of the debt securities of a particular series, we may block the transfer or exchange of debt securities during a specified period of time in order to freeze the list of holders to prepare the mailing. The period begins 15 days before the day we first mail the notice of redemption and ends on the day of that mailing. We may also refuse to register transfers or exchanges of debt securities selected or called for redemption. However, we will continue to permit transfers and exchanges of the unredeemed portion of any security being partially redeemed.
Payment and Paying Agents
We will pay interest to the security holder if he or she is a direct holder of debt securities at the close of business on a particular day in advance of each due date for interest, even if the security holder no longer owns the security on the interest due date. That particular day, usually about two weeks in advance of the interest due date, is called the record date and is stated in the applicable prospectus supplement.
Unless provided otherwise in the applicable prospectus supplement, we will pay interest, principal and any other money due on debt securities in registered form at the corporate trust office of The Bank of New York Mellon (as successor paying agent to JPMorgan Chase Bank) in the Borough of Manhattan, The City and State of New York as paying agent for the debt securities. That office is located at The Bank of New York Mellon, 240 Greenwich Street, New York, New York 10286. At our option, we may pay interest on any debt securities by check mailed to the registered holders.
Some of the debt securities may be denominated, and payments may be made, in currencies other than US dollars or in composite currencies. A summary of any special considerations which apply to these debt securities is in the applicable prospectus supplement.
Street name and other indirect holders should consult their banks or brokers for information on how they will receive payments.
We may arrange for additional payment offices, or may cancel or change these offices, including our use of the trustee’s corporate trust office. These offices are called paying agents. We may also choose to act as our own paying agent, but must always maintain a paying agency in the Borough of Manhattan, The City and State of New York. Whenever there are changes in the paying agents for any particular series of debt securities we must notify the trustee.
Payment of Additional Amounts
Unless provided otherwise in the applicable prospectus supplement, we agree that any amounts to be paid by us under any series of debt securities of principal, premium and interest in respect of the debt securities will be paid without deduction or withholding for, any and all present and future taxes, levies, duties, assessments, imposts or other governmental charges of whatever nature imposed, assessed, levied or collected by or for the account of the government of any jurisdiction in which we are resident for tax purposes (at the time of the issuance, the UK) or any political subdivision or taxing authority of such jurisdiction, unless such withholding or deduction is required by law. If such deduction or withholding is at any time required, we will (subject to compliance by the security holder with any relevant administrative requirements) pay such additional amounts as will result in the receipt of such amounts as would have been received by the holder had no such withholding or deduction been required.
The indenture provides that we will not have to pay additional amounts in certain specified circumstances, and that those circumstances may be modified or supplemented for different series of debt securities. Unless the applicable prospectus supplement for a series of debt securities provides otherwise, debt securities issued using this prospectus will provide that we will not have to pay additional amounts if:
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the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for the holder’s (or certain related parties’) connection to the jurisdiction in which we are resident for tax purposes, other than by merely holding the debt security or by receiving principal, premium, if any, or interest, if any, on the debt security, or enforcing the debt security. These connections include where the holder or related party: |
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is or has been a domiciliary, national or resident of such jurisdiction; |
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is or has been engaged in a trade or business in such jurisdiction; |
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has or had a permanent establishment in such jurisdiction; or |
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is or has been physically present in such jurisdiction. |
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the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for presentation of the debt security for payment, if presentation is required, more than 30 days after the security became due or payment was provided for; |
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the tax, levy, impost or other governmental charge is an estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge; |
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the tax, levy, impost or other governmental charge is payable in a manner that does not involve deduction or withholding from payments on or in respect of the relevant debt security; |
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the tax, levy, impost or other governmental charge would not have been imposed or withheld but for the failure of the holder or beneficial owner to comply with any certification, identification or other reporting requirement concerning the nationality, residence, identity or connection with any jurisdiction in which we are resident for tax purposes, as required by any treaty, statute, regulation or administrative practice of such jurisdiction as a condition to relief or exemption from such tax, levy, impost or other governmental charge; |
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the holder would have been able to avoid such withholding or deduction by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form required by the relevant tax authority, a declarative, claim, certificate, document or other evidence establishing exemption therefrom; |
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the tax, levy, impost or other governmental charge is imposed by the US or any political subdivision or taxing authority thereof or therein; |
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the holder of the debt security is a fiduciary, partnership or a person other than the sole beneficial owner of any payment that would be required, by the laws of the jurisdiction in which we are resident for tax purposes, to be included in income, for tax purposes, of a beneficiary or settlor with respect to |
the fiduciary, a member of that partnership or a beneficial owner who would not have been entitled to the additional amounts had that beneficiary, settlor, partner or beneficial owner been the holder; or
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any combination of the exceptions listed above. |
Mergers and Similar Events
We are generally permitted to consolidate or merge with another company or other entity that is organized under the laws of the UK, the US or any other country which is a member of the Organization for Economic Cooperation and Development. We are also generally permitted to sell or convey our property as an entirety or substantially as an entirety to such other entity. Our ability to take some of these actions is restricted in the following ways:
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any entity succeeding us must assume our obligations in relation to the debt securities and under the indenture; and |
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if the succeeding entity is not organized under the laws of the UK or a State of the United States, the succeeding entity’s assumption of our obligations in relation to the debt securities and under the indenture must include the obligation to pay any additional amounts as described under “— Payment of Additional Amounts”. |
It is possible that the merger, sale, or lease of all or substantially all of our assets would cause a principal property of ours or of a restricted subsidiary of ours or shares of stock or indebtedness of any of our restricted subsidiaries to become subject to a lien giving other lenders preferential rights in that property over holders of debt securities. We have promised to limit these preferential rights on our property, called liens, as discussed under “— Limitation on Liens”. If a merger or other transaction would create any impermissible liens on our property, we must grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
Optional Tax Redemption
Unless provided otherwise in the applicable prospectus supplement, we have the option to redeem the debt securities in the two situations described below. The redemption price for the debt securities, other than original issue discount debt securities, will be equal to the principal amount of the debt securities being redeemed plus accrued interest and any additional amounts due on the date fixed for redemption. The redemption price for original issue discount debt securities will be specified in the applicable prospectus supplement. We must give the security holder between 30 and 60 days’ notice before redeeming the debt securities.
The first situation is where, as a result of a change or amendment to any law or related regulation or ruling of the jurisdiction in which we are resident for tax purposes, or any change in an application or interpretation of such laws, regulations or rulings, or any change in application or interpretation of, or any execution of an amendment to, any treaty, we would have to pay additional amounts as described under “—Payment of Additional Amounts”.
This first situation applies only in the case of changes, amendments, applications, interpretations or executions that occur on or after the date specified in the prospectus supplement for the applicable series of debt securities (or if no such date is specified, the first date on which debt securities of such series were issued). If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes, and the applicable date will be the date such entity became successor, rather than the date specified in the preceding sentence.
The second situation is where our independent legal advisor has advised us that, as a result of action taken by a taxation authority of, or any action brought in a court of competent jurisdiction in, the jurisdiction in which we are resident for tax purposes, after the date specified in the prospectus supplement for the applicable series of debt securities, we would have to pay additional amounts as described under “—Payment of Additional Amounts” and the payment of such additional amounts cannot be avoided by the use of reasonable measures available to us. If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes and the applicable date will be the date such entity became our successor.
Covenants
Limitation on Liens
Some of our property and the property of our subsidiaries may be subject to a mortgage, pledge, assignment, charge or other legal mechanism that gives a lender preferential rights in that property over other lenders, including the security holder and the other direct holders of the debt securities, or over our general creditors if we fail to repay them. These preferential rights are generally called liens.
We undertake that we and certain of our subsidiaries, which we refer to as “restricted subsidiaries”, will not become obligated on any new debt for borrowed money that is secured by a lien on any principal property or on any shares of stock or indebtedness of any of our restricted subsidiaries unless we grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
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Restricted subsidiary means any wholly-owned subsidiary: |
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with substantially all of its property located within the UK or the US; and |
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which owns a principal property; |
but does not include any wholly-owned subsidiary principally engaged in leasing or in financing installment receivables or principally engaged in financing the operations of us and our consolidated subsidiaries.
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A wholly-owned subsidiary means any corporation in which control, directly or indirectly, of all of the stock with ordinary voting power to elect the board of directors of that corporation is owned by us, or by one or more of our wholly-owned subsidiaries or by us and one or more of our wholly-owned subsidiaries. |
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A subsidiary, with respect to any person, is any corporation in which that person owns or controls directly or indirectly at least a majority of stock with ordinary voting power to elect a majority of the board of directors. |
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Principal property means any manufacturing plant or facility or any research facility owned by us or any restricted subsidiary. A principal property must also be located within the UK or the US and have a gross book value (before deducting any depreciation reserve) exceeding 2% of our consolidated net tangible assets. Principal property does not include: |
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any plant or facility or research facility which in the opinion of our board of directors is not materially important to the total business conducted by us and our subsidiaries; or |
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any portion of a property described above which, in the opinion of our board of directors, is not materially important to the use or operation of the property. |
We do not need to comply with this restriction if the amount of all debt that would be secured by liens on our principal properties and the shares of stock or indebtedness of our restricted subsidiaries is no more than 15% of our consolidated net tangible assets.
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Our consolidated net tangible assets mean AstraZeneca PLC’s consolidated total assets, after deducting: |
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all liabilities due within one year (other than short-term borrowings and long-term debt due within one year); and |
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all goodwill, trade names, trademarks, patents and other similar types of intangible assets as shown on the audited consolidated balance sheet contained in the latest annual report to our shareholders. |
This restriction on liens does not apply to debt secured by a number of different types of liens. These types of liens include the following:
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any lien on property, shares of stock or indebtedness of any corporation existing at the time the corporation becomes a restricted subsidiary; |
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any lien on property or shares of stock existing at the time of acquisition of that property or those shares of stock, or to secure the payment of all or any part of the purchase price of that property or those shares of stock, or to secure any debt incurred before, at the time of, or within twelve months after, in the case of shares of stock, the acquisition of the shares of stock and, in the case of property, the later of the acquisition, completion of construction (including any improvements on an existing property) or commencement of the commercial operation of the property, where the debt is incurred to finance all or any part of the purchase price; |
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any lien securing debt owed to us or to any of our restricted subsidiaries by us or any of our restricted subsidiaries; |
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any lien existing at the date of the indenture; |
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any lien on a principal property to secure debt incurred to finance all or part of the cost of improving, constructing, altering or repairing any building, equipment or facilities or of any other improvements on all or any part of that principal property, if the debt is incurred before, during, or within twelve months after completing the improvement, construction, alteration or repair; |
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any lien on property owned or held by any corporation or on shares of stock or indebtedness of any corporation, where the lien existed either at the time the corporation is merged, consolidated or amalgamated with either us or a restricted subsidiary or at the time of a sale, lease or other disposition of all or substantially all of the property of a corporation to us or a restricted subsidiary; |
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any lien arising by operation of law and not securing amounts more than 90 days overdue or otherwise being contested in good faith; |
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any lien arising by operation of law over any credit balance or cash held in any account with a financial institution; |
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any rights of financial institutions to offset credit balances in connection with the operation of cash management programs established for our benefit and/or the benefit of any restricted subsidiary; |
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any lien incurred or deposits made in the ordinary course of business, including but not limited to: |
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any mechanics’, materialmen’s, carriers’, workmen’s, vendors’ or other similar liens; |
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any liens securing amounts in connection with workers’ compensation, unemployment insurance and other types of social security; and |
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any easements, rights-of-way, restrictions and other similar charges; |
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any liens incurred or deposits made securing the performance of tenders, bids, leases, statutory obligations, surety and appeal bonds, government contracts, performance and return of money bonds and other obligations of a similar nature incurred in the ordinary course of business; |
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any lien securing taxes or assessments or other applicable governmental charges or levies; |
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any extension, renewal or replacement or successive extensions, renewals or replacements, in whole or in part, of any lien included in the preceding paragraphs or of any of the debt secured under the preceding paragraphs, so long as the principal amount of debt secured does not exceed the principal amount of debt secured at the time of the extension, renewal or replacement, and that the extension, renewal or replacement lien is limited to all or any part of the same property or shares of stock that |
secured the lien extended, renewed or replaced (including improvements on that property), or property received or shares of stock issued in substitution or exchange; and
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any lien in favor of us or any subsidiary of ours. |
The following types of transactions will not be deemed to create debt secured by a lien and, therefore, will also not be subject to the restriction on liens:
· |
any liens on property of ours or a restricted subsidiary in favor of the US or any State of the US, or the UK, or any other country, or any political subdivision of, or any department, agency or instrumentality of, these countries or states, to secure partial, progress, advance or other payments under provisions of any contract or statute including, but not limited to, liens to secure debt of pollution control or industrial revenue bond type, or to secure any indebtedness incurred for the purpose of financing all or any part of the purchase price or cost of construction of the property subject to these liens. |
Limitation on Sale and Lease-Back Transactions
Neither we nor any of our restricted subsidiaries will enter into any sale and lease-back transaction involving a principal property without complying with this covenant.
A sale and lease-back transaction is an arrangement between us or a restricted subsidiary and any person in which we or the restricted subsidiary leases back for a term of more than three years a principal property that we or the restricted subsidiary has sold or transferred to that person.
We and our restricted subsidiaries may enter into sale and lease-back transactions provided that the total amount of attributable debt attributable to all sale and lease-back transactions plus other debt of ours or any of our restricted subsidiaries that is secured by liens (but excluding debt secured by liens on property that we or a restricted subsidiary would be entitled to incur, assume or guarantee without equally and ratably securing the debt securities offered by this prospectus as described under “— Limitation on Liens” above) does not exceed 15% of consolidated net tangible assets.
This restriction does not apply to any sale and lease-back transaction if:
· |
we or the restricted subsidiary seeking to enter into the sale and lease-back could incur, assume or guarantee debt secured by a lien on the principal property to be leased without equally and ratably securing the debt securities offered by this prospectus as a result of one or more of the exceptions to the limitation on liens as described under “— Limitation on Liens” above; |
· |
within twelve months before or after the sale or transfer, regardless of whether the sale or transfer may have been made by us or a restricted subsidiary, we apply, an amount equal to the net proceeds of the sale or transfer (in the case of a sale or transfer for cash), or an amount equal to the fair value of the principal property so leased at the time of entering into the sale or transfer as determined by our board of directors (in the case of a sale or transfer otherwise than for cash), to |
· |
the retirement of indebtedness for money borrowed, incurred or assumed by us or any restricted subsidiary which matures at, or is extendible or renewable at the option of the obligor to, a date more than twelve months after the date of incurring, assuming or guaranteeing such debt, or |
· |
investment in any principal property or principal properties. |
This restriction on sale and lease-back transactions also does not apply to any transaction between us and a restricted subsidiary, or between restricted subsidiaries.
Attributable debt means the present value (discounted at a rate equal to the weighted average of the rate of interest on all securities then issued and outstanding under the indenture, compounded semi-annually) of our or a restricted subsidiary’s obligation for rental payments for the remaining term of any lease in a sale and lease-back transaction.
Default and Related Matters
Events of Default
A holder of debt securities of a particular series will have special rights if any event of default occurs with respect to that series and is not cured, as described later in this subsection.
What is an event of default? An event of default means any of the following:
· |
Interest — default for 30 days in the payment of any installment of interest on the series of debt securities; |
· |
Principal — default in the payment of all or any part of the principal of the series of debt securities when such principal becomes due and payable either at maturity, upon redemption, by acceleration or otherwise; |
· |
Sinking Fund Installment — default in the payment of any sinking fund installment as and when such installment becomes due and payable by the specific terms of the series of debt securities or beyond any period of grace; |
· |
Covenant — breach or default by us in the performance of a covenant or warranty in respect of the debt securities of the relevant series which has not been remedied for ninety days after we receive written notice of the default from the trustee or we and the trustee receive written notice of the default from the holders of at least 25% of the principal amount of the debt securities of all affected series; |
· |
Bankruptcy — certain events of bankruptcy, insolvency or reorganization affecting us; or |
· |
Other — any other event of default provided in any supplemental indenture or resolution of our board of directors under which a particular series is issued or in the form of security for such series. |
No event of default described in the provisions above with respect to a particular series of debt securities will necessarily constitute an event of default with respect to any other series of debt securities and the events of default for any specific series may be modified as described in the applicable prospectus supplement.
Remedies if an event of default occurs. If an event of default, other than a “Bankruptcy” default, has occurred (but only if, in the case of a “Covenant” default, the default has occurred for less than all series of debt securities then issued under the indenture and outstanding) and has not been cured, the trustee or the holders of at least 25% of the principal amount of debt securities of the affected series (each affected series voting as a separate class) may declare the principal amount (or, if the debt securities of a series are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all the debt securities of that series, together with any accrued interest, to be due and payable immediately. If an event of default has occurred under “Covenant” default with respect to all of the series of debt securities then issued under the indenture and outstanding, or under “Bankruptcy” default, and has not been cured, the trustee or the holders of at least 25% of the principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class) may declare the principal (or, if any debt securities are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all debt securities then issued under the indenture and outstanding, together with any accrued interest, to be due and payable immediately. This is called a declaration of acceleration of maturity. A declaration of acceleration of maturity may be canceled by the holders of at least a majority in principal amount of the debt securities of the affected series or by at least a majority in principal amount of all the debt securities then issued under the indenture and outstanding (voting as one class), as the case may be, if certain conditions are met.
Before a declaration of acceleration of maturity, past “Covenant” defaults that do not affect all series of debt securities then issued under the indenture and outstanding may be waived by the holders of a majority in principal amount of the debt securities then outstanding of each affected series (each such series voting as a separate class). Past “Covenant” defaults that affect all series of debt securities then issued under the indenture and outstanding and past “Bankruptcy” defaults may be waived by the holders of a majority in principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class). Default in the payment of principal of or interest on or any sinking fund installment of debt securities of any series or a covenant or provision of the indenture that cannot be modified or amended without the consent of the holder of each debt security affected may only be modified or amended with the consent of such holder.
Except in cases of default, where the trustee has some special duties, the trustee is not required to take any action under the indenture at the request of any holders unless the holders offer the trustee reasonable protection from expenses and liability. This protection is called an indemnity. If reasonable indemnity is provided, the holders of a majority in principal amount of the outstanding debt securities of the relevant series may, subject to certain limitations and conditions, direct the time, method and place of conducting any lawsuit or other formal legal action seeking any remedy available to the trustee. These majority holders may also, subject to certain limitations and conditions, direct the trustee in performing any other action under the indenture.
Before the security holder bypasses the trustee and bring his or her own lawsuit or other formal legal action or takes other steps to enforce his or her rights or protects his or her interests relating to the debt securities, the following must occur:
· |
the security holder must give the trustee written notice that an event of default has occurred and remains uncured; |
· |
the holders of 25% in principal amount of all outstanding debt securities of the relevant series must make a written request that the trustee take action because of the default, and must offer reasonable indemnity to the trustee against the cost and other liabilities of taking that action; and |
· |
the trustee must have not taken action for 60 days after receipt of the above notice and offer of indemnity and the trustee has not received an inconsistent direction from the holders of a majority in principal amount of all outstanding debt securities of the relevant series during that period. |
These limitations do not apply to a suit instituted by the security holder for the enforcement of payment of the principal or interest on a debt security on or after the respective due dates.
We will file annually with the trustee on or before March 31 in each year a written statement of certain of our officers certifying that, to their knowledge, we have not defaulted on our covenants under the indenture or else specifying any default that exists.
For any series of debt securities that is a series of original issue discount securities the applicable prospectus supplement will contain provisions for the acceleration of the maturity of a portion of the principal amount of such original issue discount securities.
Modification of the Indenture and Waiver
There are three types of changes we can make to the indenture and any series of the debt securities.
Changes not requiring approval. The first type of change does not require any vote by holders of debt securities. The security holder’s consent is not required to do any of the following:
· |
to transfer or pledge any property or assets to the trustee as security for any series of the debt securities; |
· |
to evidence the succession of any successor corporation to us as described under “Mergers and Similar Events” above; |
· |
to evidence the succession of any successor trustee under the indenture or to add to or change any provisions of the indenture as necessary to provide for the appointment of an additional trustee or trustees; |
· |
to add to our covenants or to add additional events of default for the benefit of the holders of any series of the debt securities; |
· |
to cure any ambiguity or to correct or supplement any provision of the indenture that may be defective or inconsistent with any other provision of the indenture; or |
· |
to make any other provisions with respect to matters or questions arising under the indenture as our board of directors may deem necessary or desirable and that shall not adversely affect the interests of holders of any series of the debt securities in any material respect. |
Changes requiring the approval of a majority of holders. The second type of change to the indenture and the debt securities requires a vote in favor by holders of debt securities owning at least a majority of the principal amount of all series of debt securities then outstanding and affected by such charge (each affected series voting as a separate class). In this manner, any provision of the indenture or any series of debt securities may be changed or eliminated unless the provision relates to a matter that requires the consent of each affected holder as discussed below.
Changes requiring the security holder’s approval. Third, there are changes that cannot be made to the security holder’s debt securities without the specific approval of each affected holder. The security holder’s consent is required before we could do any of the following:
· |
extend the final maturity of a debt security; |
· |
reduce the principal amount of a debt security; |
· |
reduce the rate or extend the time of payment of any interest on a debt security; |
· |
reduce any amount payable on redemption of a debt security; |
· |
reduce the amount of principal due and payable upon an acceleration of the maturity or provable in bankruptcy of a debt security issued at an original issue discount; |
· |
impair the security holder’s right to sue for payment; |
· |
impair any right of repayment at the option of the holder; |
· |
reduce the percentage of holders of debt securities whose consent is needed to modify or amend the indenture; or |
· |
change in any manner adverse to the holders of the debt securities our obligations relating to the payment of principal and interest, and sinking fund payments. |
Satisfaction, Discharge and Defeasance
We may terminate our repayment and obligations on the debt securities, when:
· |
we have paid or caused to be paid the principal of and interest, if any, then due and payable on all outstanding debt securities of any series; or |
· |
we have delivered to the trustee for cancellation all outstanding debt securities of any series; or |
· |
all the outstanding debt securities of the series that have not been delivered to the trustee for cancellation have become or will become due and payable within one year and we have made arrangements satisfactory to the trustee for the giving of notice of redemption by the trustee in our name; and |
· |
we have deposited with the trustee sufficient funds to pay and discharge the entire indebtedness on the series of debt securities to pay principal and interest, if any, and paid all other sums payable under the indenture. |
We may legally release ourselves from any payment or other obligations on the debt securities, except for various obligations described below, if we, in addition to other actions, put in place the following arrangements for the security holder:
· |
we must deposit in trust for the security holder’s benefit and the benefit of all other direct holders of the debt securities a combination of money and government obligations that will generate enough cash to make interest, principal and any other payments on the debt securities on their various due dates; and |
· |
we must deliver to the trustee a legal opinion of our counsel to the effect that the holders of the debt securities of that series will not recognize gain or loss for US federal income tax purposes as a result of |
the defeasance and will be subject to the same US federal income tax as would be the case if the defeasance did not occur.
However, even if we take these actions, a number of our obligations relating to the debt securities will remain. These include the following obligations:
· |
to register the transfer and exchange of debt securities and our right of optional redemption, if any; |
· |
to replace mutilated, defaced, destroyed, lost or stolen debt securities; |
· |
to pay principal and interest, if any, on the original stated due dates and any remaining rights of the holders to receive sinking fund payments, if any, from funds deposited with the trustee; |
· |
immunities of the trustee; and |
· |
to hold money for payment in trust. |
Government obligation means securities that are:
· |
direct obligations of the US or any foreign government of a sovereign state for the payment of which is pledged by the full faith and credit of the US or such foreign government; or |
· |
obligations of an entity controlled or supervised by and acting as an agency or instrumentality of the US or any foreign government of a sovereign state the payment of which is unconditionally guaranteed as a full faith and credit obligation of the US or such foreign government; |
and are not callable or redeemable at the option of the issuer. Government obligation also includes:
· |
a depositary receipt issued by a bank or trust company as custodian for these government obligations, or specific payment of interest on or principal of these government obligations, held by such custodian for the account of the holder of a depositary receipt, provided that (except as required by law) such custodian is not authorized to make any deductions from the amount payable to the holder of such depositary receipt from any amount received by the custodian in respect of these government obligations, or the specific payment of interest on or principal of these government obligations, evidenced by such depositary receipt. |
Notices
We and the trustee will send notices only to direct holders, using their addresses registered in the trustee’s records.
Regardless of who acts as paying agent, all money that we pay to a paying agent that remains unclaimed at the end of two years after the amount is due to direct holders of debt securities will be repaid to us. After that two-year period, the security holder may look only to us for payment and not to the trustee, any other paying agent or anyone else.
Governing Law
The debt securities and the indenture will be governed by and construed in accordance with the laws of the State of New York.
Concerning the Trustee
The Bank of New York Mellon acts as the trustee with respect to certain debt securities of certain of our subsidiaries.
If an event of default occurs, or an event occurs that would be an event of default if the requirements for either giving us notice or our default having to exist for a specified time period were disregarded, the trustee may be considered to have a conflicting interest with respect to the debt securities or the indenture for purposes of the Trust Indenture Act of 1939.
In that case, the trustee may be required to resign as trustee under the applicable indenture and we would be required to appoint a successor trustee.
E. |
6.450% Notes due 2037 |
Prospectus Supplement:
DESCRIPTION OF NOTES
General
We offered $2,750,000,000 initial aggregate principal amount of 6.45% Notes due 2037 (the “2037 Notes”or the “Fixed Rate Notes” or the “notes”). The notes are governed by New York law.
The notes are unsecured, unsubordinated indebtedness of AstraZeneca PLC and rank equally with all of AstraZeneca PLC’s other unsecured and unsubordinated indebtedness.
There is no sinking fund for any series of notes. We have listed the notes on the Nasdaq Stock Market LLC.
Interest Payments and Maturity
For purposes of the description below, “business day” means a London business day on which commercial banks and foreign exchange markets are generally open to settle payments in New York. “London business day” means any day on which dealings in deposits in US dollars are transacted in the London interbank market.
Fixed Rate Notes
Maturity. The principal amount of the 2037 Notes will mature and become due and payable, together with any accrued and unpaid interest, on September 15, 2012, September 15, 2017 and September 15, 2037, respectively.
Interest Rate. The 2037 Notes will bear interest from their respective original issue date until their principal amount is paid or made available for payment, at a rate equal to 6.45% per annum, respectively, calculated on the basis of a 360-day year and twelve 30-day months.
Interest Payment Dates. Interest on the Fixed Rate Notes will be paid semi-annually in arrears on September 15 and March 15 of each year, commencing March 15, 2008 (each a “Fixed Rate Interest Payment Date”). However, if a Fixed Rate Interest Payment Date would fall on a day that is not a business day, the Fixed Rate Interest Payment Date will be postponed to the next succeeding day that is a business day, but no additional interest shall be paid unless we fail to make payment on such date.
Interest Periods. The first interest period for the Fixed Rate Notes will be the period from and including the Issue date to but excluding the first Fixed Rate Interest Payment Date. Thereafter, the interest periods for the Fixed Rate Notes will be the periods from and including the Fixed Rate Interest Payment Dates to but excluding the immediately succeeding Fixed Rate Interest Payment Date (together with the first interest period, each a “Fixed Rate Interest Period”). The final Fixed Rate Interest Period will be the period from and including the Fixed Rate Interest Payment Date immediately preceding the maturity date to the maturity date.
Redemption
As explained below, under certain circumstances we may redeem the notes before they mature. This means that we may repay them early. The security holder has no right to require us to redeem the notes. Notes will stop bearing interest on the redemption date, even if the security holder does not collect his or her money. We will give notice to DTC of any redemption we propose to make at least 30 days, but no more than 60 days, before the redemption date. Notice by DTC to participating institutions and by these participants to street name holders of indirect interests in the notes will be made according to arrangements among them and may be subject to statutory or regulatory requirements.
Optional Redemption
Fixed Rate Notes
We may redeem the Fixed Rate Notes, in whole or in part, at any time and from time to time at a redemption price equal to the greater of (i) 100% of the principal amount of the Fixed Rate Notes, and (ii) as determined by the quotation agent, the sum of the present values of the remaining scheduled payments of principal and interest of the Fixed Rate Notes to be redeemed (not including any portion of such payments of interest accrued as of the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the treasury rate plus the Make-Whole Spread (as set forth below) plus, in each case, accrued interest thereon to the date of redemption. In connection with such optional redemption, the following defined terms apply:
· |
“Treasury rate” means, with respect to any redemption date, the rate per annum equal to the semiannual equivalent yield to maturity of the comparable treasury issue, assuming a price for the comparable treasury issue (expressed as a percentage of its principal amount) equal to the comparable treasury price for such redemption date. |
· |
“Comparable treasury issue” means the United States Treasury security selected by the quotation agent as having a maturity comparable to the remaining term of the applicable series of Fixed Rate Notes to be redeemed that would be utilized, at the time of selection and in accordance with customary financial practice, in pricing new issues of corporate debt securities of comparable maturity to the remaining term of such series of Fixed Rate Notes. |
· |
“Comparable treasury price” means, with respect to any redemption date, (i) the average of the reference treasury dealer quotations for such redemption date, after excluding the highest and lowest such reference treasury dealer quotations, or (ii) if the trustee obtains fewer than three such reference treasury dealer quotations, the average of all such quotations. |
· |
“Quotation agent” means the reference treasury dealer appointed by us. |
· |
“Reference treasury dealer” means (i) each of Citigroup Global Markets Inc., Deutsche Bank Securities Inc., Goldman, Sachs & Co., HSBC Securities (USA), and J.P. Morgan Securities Inc., and their respective successors; provided, however, that if the foregoing shall cease to be a primary US government securities dealer in New York City (a “primary treasury dealer”), we shall substitute therefor another primary treasury dealer; and (ii) any other primary treasury dealer selected by us. |
· |
“Reference treasury dealer quotations” means, with respect to each reference treasury dealer and any redemption date, the average, as determined by the quotation agent, of the bid and asked prices for the comparable treasury issue (expressed in each case as a percentage of its principal amount) quoted in writing to the trustee by such reference treasury dealer at 5:00 p.m., Eastern Standard Time, on the third business day preceding such redemption date. |
· |
“Make-Whole Spread” means 30 basis points. |
Optional Tax Redemption
In the event of various tax law changes after the date of this prospectus supplement and other limited circumstances that require us to pay additional amounts, as described in the Base Prospectus under “Description of Debt Securities — Payment of Additional Amounts”, we may redeem the notes for redemption at a price equal to 100% of the principal amount of the notes plus accrued interest to the date of redemption. This means we may repay the notes early. We discuss our ability to redeem the notes in greater detail under “Description of Debt Securities — Optional Tax Redemption”.
Repurchase upon Change of Control Repurchase Event
If a Change of Control Repurchase Event (as defined below) occurs with respect to the notes, unless the notes are otherwise subject to redemption as described under “— Redemption” above and we have elected to exercise our right to redeem such notes, we will make an offer to each holder of notes to repurchase all or any part (in integral multiples of $1,000) of that holder’s notes at a repurchase price in cash equal to 101% of the aggregate principal amount of notes repurchased plus any accrued and unpaid interest on the notes repurchased to the date of repurchase.
Within 30 days following any Change of Control Repurchase Event or, at our option, prior to any Change of Control (as defined below), but after the public announcement of an impending Change of Control, we will mail a notice to each holder, with a copy to the trustee, describing the transaction or transactions that constitute or may constitute the Change of Control Repurchase Event and offering to repurchase notes on the payment date specified in the notice, which date will be no earlier than 30 days and no later than 60 days from the date such notice is mailed. The notice shall, if mailed prior to the date of consummation of the Change of Control, state that the offer to repurchase is conditioned on the Change of Control Repurchase Event occurring on or prior to the payment date specified in the notice.
We will comply with the requirements of Rule 14e-1 under the Exchange Act and any other securities laws and regulations thereunder, to the extent those laws and regulations are applicable in connection with the repurchase of the notes as a result of a Change of Control Repurchase Event. To the extent that the provisions of any securities laws or regulations conflict with the Change of Control Repurchase Event provisions of the notes, we will comply with the applicable securities laws and regulations and will not be deemed to have breached our obligations under the Change of Control Repurchase Event provisions of the notes by virtue of such conflict.
On the Change of Control Repurchase Event payment date, we will, to the extent lawful:
· |
accept for payment all notes or portions of notes (in integral multiples of $1,000) properly tendered pursuant to our offer; |
· |
deposit with the trustee an amount equal to the aggregate repurchase price in respect of all notes or portions of notes properly tendered; and |
· |
deliver or cause to be delivered to the trustee the notes properly accepted, together with an officers’ certificate stating the aggregate principal amount of notes being purchased by us. |
The trustee will promptly mail to each holder of notes properly tendered the repurchase price for the notes, and the trustee will promptly authenticate and mail (or cause to be transferred by book-entry) to each holder a new note equal in principal amount to any unpurchased portion of any notes surrendered; provided, that each new note will be in a principal amount of $1,000 or an integral multiple of $1,000 in excess thereof.
We will not be required to make an offer to repurchase the notes upon Change of Control Repurchase Event if a third party makes such an offer in the manner, at the times and otherwise in compliance with the requirements for an offer made by us, and such third party purchases all notes properly tendered and not withdrawn under its offer.
Definitions
“Below Investment Grade Rating Event” means the notes are rated below Investment Grade by each of the Rating Agencies on any date from the date of the public notice of an arrangement that could result in a Change of Control until the end of the 60-day period following public notice of the occurrence of a Change of Control (which period shall be extended so long as the rating of the notes is under publicly announced consideration for possible downgrade by any of the Rating Agencies); provided that a Below Investment Grade Rating Event otherwise arising by virtue of a particular reduction in rating shall not be deemed to have occurred in respect of a particular Change of Control (and thus shall not be deemed a Below Investment Grade Rating Event for purposes of the definition of Change of Control Repurchase Event hereunder) if the Rating Agencies making the reduction in rating to which this definition would otherwise apply do not announce or publicly confirm or inform the trustee in writing at its request that the reduction was the result, in whole or in part, of any event or circumstance comprised of or arising as a result of, or in respect of, the applicable Change of Control (whether or not the applicable Change of Control shall have occurred at the time of the Below Investment Grade Rating Event).
“Change of Control” means the occurrence of any of the following: (1) the direct or indirect sale, transfer, conveyance or other disposition (other than by way of merger or consolidation), in one or a series of related transactions, of all or substantially all of the properties or assets of AstraZeneca PLC and its subsidiaries taken as a whole to any “person” (as that term is used in Section 13(d)(3) of the Exchange Act), other than AstraZeneca PLC or one of its subsidiaries; (2) the consummation of any transaction (including, without limitation, any merger or consolidation) the result of which is that any “person” (as that term is used in Section 13(d)(3) of the Exchange Act) becomes the beneficial owner, directly or indirectly, of more than 50% of the then outstanding number of shares of Astra Zeneca PLC’s Voting Stock; or (3) the first day on which a majority of the members of AstraZeneca PLC’s Board of Directors are not Continuing Directors.
“Change of Control Repurchase Event” means the occurrence of both a Change of Control and a Below Investment Grade Rating Event.
“Continuing Directors” means, as of any date of determination, any member of the Board of Directors of AstraZeneca PLC who (1) was a member of such Board of Directors on the date of the issuance of the notes; or (2) was nominated for election or elected to such Board of Directors with the approval of a majority of the Continuing Directors who were members of such Board of Directors at the time of such nomination or election.
“Investment Grade” means a rating of Baa3 or better by Moody’s (or its equivalent under any successor rating categories of Moody’s) and a rating of BBB– or better by S&P (or its equivalent under any successor rating categories of S&P); or the equivalent investment grade credit rating from any additional Rating Agency or Rating Agencies selected by us.
“Moody’s” means Moody’s Investors Service Inc.
“Rating Agency” means (1) each of Moody’s and S&P; and (2) if any of Moody’s or S&P ceases to rate the notes or fails to make a rating of the notes publicly available for reasons outside of our control, a “nationally recognized statistical rating organization” within the meaning of Rule 15c3-1(c)(2)(vi)(F) under the Exchange Act, selected by us as a replacement agency for Moody’s or S&P, as the case may be.
“S&P” means Standard & Poor’s Ratings Services, a division of McGraw-Hill, Inc.
“Voting Stock” means AstraZeneca PLC’s issued ordinary share capital.
Further Issuances
We may, without the consent of the holders of notes, issue additional notes having the same ranking and same interest rate, maturity date, redemption terms and other terms as the notes described in this prospectus supplement. Any such additional notes, together with the notes offered by this prospectus supplement, will constitute a single series of securities under the Indenture. There is no limitation on the amount of notes or other debt securities that we may issue under such indenture.
We may offer additional notes of with OID for US federal income tax purposes as part of a further issue. Purchasers of notes after the date of any further issue will not be able to differentiate between notes sold as part of such further issue and previously issued notes. If we were to issue additional notes with OID, purchasers of notes after such further issue may be required to accrue OID (or greater amounts of OID than they would otherwise have accrued) with respect to their notes. This may affect the price of outstanding notes following a further issue. Purchasers are advised to consult legal counsel with respect to the implications of any future decision by us to undertake a further issue of notes of any series with OID.
Form, Denomination, Clearance and Settlement
We will issue the notes in fully registered form. The notes will be represented by one or more global securities registered in the name of a nominee of DTC. The security holder will hold beneficial interests in the notes through DTC in book-entry form. The notes will be issued in minimum denominations of $1,000 and in integral multiples of $1,000. The underwriters expect to deliver the notes through the facilities of DTC on September 12, 2007. Indirect holders trading their beneficial interests in the notes through DTC must trade in DTC’s same-day funds settlement system and pay in immediately available funds. Secondary market trading through Euroclear and Clearstream, Luxembourg will occur in the ordinary way following the applicable rules and operating procedures of Euroclear and Clearstream, Luxembourg.
Payment of principal of and interest on the notes, so long as the notes are represented by global securities, as discussed below, will be made in immediately available funds. Beneficial interests in the global securities will trade in the same-day funds settlement system of DTC, and secondary market trading activity in such interests will therefore settle in same-day funds.
Payment of Additional Amounts
For more information on additional amounts and the situations in which AstraZeneca PLC may be required to pay additional amounts, see “Description of Debt Securities — Payment of Additional Amounts” in the Base Prospectus below.
Defeasance and Discharge
We may release ourselves from any payment or other obligations on the notes as described under “Description of Debt Securities — Satisfaction, Discharge and Defeasance” in the Base Prospectus.
Paying Agent and Calculation Agent
The principal corporate trust office of the trustee in The City of New York is designated as the principal paying agent. See “— Trustee” immediately below. We may at any time designate additional paying agents or rescind the designation of paying agents or approve a change in the office through which any paying agent acts.
Trustee
As a result of the transfer of JPMorgan Chase Bank’s corporate trust business to The Bank of New York effective October 1, 2006, The Bank of New York is the trustee under the Indenture. The trustee’s address is The Bank of New York, Corporate Trust Office, 101 Barclay Street, New York, NY 10286. The trustee will also serve as the principal paying agent for the notes. See “— Paying Agent and Calculation Agent” immediately above.
Base Prospectus:
DESCRIPTION OF DEBT SECURITIES
We may issue debt securities using this prospectus. As required by US federal law for all publicly offered corporate bonds and notes, the debt securities are governed by a document called an indenture. The indenture relating to the debt securities issued by us is a contract, dated as of April 1, 2004, between AstraZeneca PLC and JPMorgan Chase Bank, as trustee. As a result of the transfer of JPMorgan Chase Bank’s corporate trust business to The Bank of New York effective October 1, 2006, The Bank of New York is the trustee under the indenture. See “— The Trustee” below.
In this description “the security holder” means direct holders and not street name or other indirect holders of securities. Indirect holders should read the section “Legal Ownership — Street Names and Other Indirect Holders” in the Base Prospectus.
General
This section summarizes the material provisions of the indenture and the debt securities. Because it is a summary, it does not describe every aspect of the indenture or the debt securities. This summary is subject to and qualified in its entirety by reference to all of the indenture provisions, including some of the terms used and defined in the indenture. We describe the meaning of only the more important terms in this prospectus. We also include references in parentheses to some sections of the indenture. Whenever we refer to particular sections or defined terms of the indenture in this prospectus or in the prospectus supplement, those sections or defined terms are incorporated by reference here or in the prospectus supplement. This summary is also subject to and qualified by reference to the description of the particular terms of the security holder’s series of debt securities described in the prospectus supplement.
The indenture and its associated documents contain the full legal text of the matters described in this section. The indenture and the debt securities are governed by New York law. The indenture is an exhibit incorporated by reference into this prospectus.
The debt securities are unsecured obligations of AstraZeneca PLC. The debt securities will rank equally in right of payment with all of our other unsecured and unsubordinated indebtedness except for indebtedness that is preferred under applicable law.
The Trustee
The Bank of New York (as successor trustee to JPMorgan Chase Bank) is the trustee under the indenture. As trustee, it has two main roles:
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first, it can enforce the security holder’s rights against us if we default on debt securities issued under the indenture. There are some limitations on the extent to which the trustee may act on the security holder’s behalf, described under “Defaults and Related Matters — Remedies if an event of default occurs” below; and |
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second, the trustee performs administrative duties for us, such as sending the security holder interest payments and notices. |
Types of Debt Securities
The indenture does not limit the amount of debt securities that we can issue. It provides that debt securities may be issued in one or more series up to the aggregate principal amount as we authorize from time to time. All debt securities of one series need not be issued at the same time and we may reopen any series, without the consent of a holder of that series, to issue additional debt securities of the same series.
The prospectus supplement relating to a series of debt securities will describe the following terms of the series:
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the title of the series of debt securities; |
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the aggregate principal amount of debt securities and any limit on the aggregate principal amount of the series of debt securities; |
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any stock exchange on which we will list the debt securities; |
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the date or dates on which we will repay the principal amount of the series of debt securities or the method by which the date or dates will be determined; |
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any rate or rates at which the series of debt securities will bear interest or the method by which the interest rate or rates will be determined; |
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the date or dates from which any interest on the series of debt securities will accrue, the dates on which interest will be payable and the record dates for interest payments or the method by which such date or dates will be determined and the method by which interest will be calculated if different to a 360-day year of twelve 30-day months; |
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the place or places where the principal and any interest on debt securities will be payable if other than the corporate trust office of the trustee in New York, New York; |
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the price or prices at which, the period or periods within which, the currency or currencies, currency unit or composite currency in which, and the terms and conditions upon which we may redeem the series of debt securities in whole or in part; |
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any right or obligation to redeem, repay or purchase the debt securities as a result of any sinking fund or similar provisions, or at the option of the holder of the debt securities and the period or periods within which, the price or prices at which and every other terms and conditions upon which the debt securities will be redeemed, repaid or purchased; |
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the denominations in which debt securities of the series are issuable, if other than denominations of $1,000 and any multiple of $1,000; |
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the portion of the principal amount of the series of debt securities payable if an acceleration of the maturity of the debt securities is declared, if other than the principal amount; |
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the currency, including any composite currency, of payment of the principal, premium, if any, and interest on the series of debt securities if other than US dollars; |
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whether we or a holder of debt securities may elect to have the principal, premium, if any, or interest on the series of debt securities paid in a currency or composite currency other than the currency in which the debt securities are stated to be payable, and if so, any election period and the terms and conditions governing such an election; |
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whether we will be required to pay additional amounts for withholding taxes or other governmental charges and, if applicable, a related right to an optional tax redemption for such a series; |
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any index used to determine the amount of payment of principal, premium, if any, and interest on the series of debt securities and how these amounts will be determined if they are not fixed when the debt securities are issued; |
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the forms of the series of debt securities; |
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the applicability of the provisions described later under “— Satisfaction, Discharge and Defeasance”; |
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any authenticating or paying agents, transfer agents or registrars or any other agents acting in connection with the debt securities other than the trustee; |
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if applicable, a discussion of any additional material US federal income and UK tax considerations; and |
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any other special features of the series of debt securities. |
We may issue the debt securities as original issue discount securities, which are debt securities offered and sold at a substantial discount to their stated principal amount.
Overview of the Remainder of this Description
The remainder of this description summarizes:
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Additional mechanics relevant to the debt securities under normal circumstances, such as how the security holder transfers ownership and where we make payments. |
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The security holder’s right to receive payment of additional amounts due to changes in the tax withholding requirements of various jurisdictions. |
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The security holder’s rights under several special situations, such as if we merge with another company or if we want to redeem the debt securities for tax reasons. |
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Covenants contained in the indenture that restrict our ability to incur liens and undertake sale and leaseback transactions. A particular series of debt securities may have different covenants. |
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The security holder’s rights if we default. |
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The security holder’s rights if we want to modify the indenture. |
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Our relationship with the trustee. |
Additional Mechanics
Exchange and Transfer
Unless otherwise stated in the prospectus supplement, the debt securities will be issued only in fully registered form without interest coupons in denominations of $1,000 or whole multiples of $1,000. The security holder may have his or her debt securities broken into more debt securities of smaller $1,000 denominations or combined into fewer debt securities of larger $1,000 denominations, as long as the total principal amount is not changed.
This is called an exchange.
The security holder may exchange or transfer registered debt securities at the office of the trustee. The trustee acts as our agent for registering debt securities in the names of holders and for transferring registered debt securities. We may change this appointment to another entity or perform the service ourselves. The entity performing the role of maintaining the list of registered holders is called the security registrar. It will also register transfers of the registered debt securities.
The security holder may not exchange his or her registered debt securities for bearer securities.
There will be no service charge for any exchange or registration of transfer of the debt securities, but we may require payment of an amount sufficient to cover any tax or other governmental charge imposed in connection with any exchange or registration of transfer.
The transfer or exchange of a registered debt security may be made only if the security registrar is satisfied with the security holder’s proof of ownership.
If the debt securities are redeemable and we redeem less than all of the debt securities of a particular series, we may block the transfer or exchange of debt securities during a specified period of time in order to freeze the list of holders to prepare the mailing. The period begins 15 days before the day we first mail the notice of redemption and ends on the day of that mailing. We may also refuse to register transfers or exchanges of debt securities selected or called for redemption. However, we will continue to permit transfers and exchanges of the unredeemed portion of any security being partially redeemed.
Payment and Paying Agents
We will pay interest to the security holder if he or she is a direct holder of debt securities at the close of business on a particular day in advance of each due date for interest, even if the security holder no longer owns the security on the interest due date. That particular day, usually about two weeks in advance of the interest due date, is called the record date and is stated in the prospectus supplement.
Unless otherwise specified in the prospectus supplement, we will pay interest, principal and any other money due on debt securities in registered form at the corporate trust office of The Bank of New York (as successor paying agent to JPMorgan Chase Bank) in the Borough of Manhattan, The City and State of New York as paying agent for the debt securities. That office is located at The Bank of New York, 101 Barclay Street, New York, New York 10286. At our option, we may pay interest on any debt securities by check mailed to the registered holders.
Some of the debt securities may be denominated, and payments may be made, in currencies other than US dollars or in composite currencies. A summary of any special considerations which apply to these debt securities is in the applicable prospectus supplement.
Street name and other indirect holders should consult their banks or brokers for information on how they will receive payments.
We may arrange for additional payment offices, or may cancel or change these offices, including our use of the trustee’s corporate trust office. These offices are called paying agents. We may also choose to act as our own paying agent, but must always maintain a paying agency in the Borough of Manhattan, The City and State of New York.
Whenever there are changes in the paying agents for any particular series of debt securities we must notify the trustee.
Payment of Additional Amounts
We agree that any amounts to be paid by us under any series of debt securities of principal, premium and interest in respect of the debt securities will be paid without deduction or withholding for, any and all present and future taxes, levies, duties, assessments, imposts or other governmental charges of whatever nature imposed, assessed, levied or collected by or for the account of the government of any jurisdiction in which we are resident for tax purposes (at the time of the issuance, the UK) or any political subdivision or taxing authority of such jurisdiction, unless such withholding or deduction is required by law.
If such deduction or withholding is at anytime required, we will (subject to compliance by the security holder with any relevant administrative requirements) pay the security holder additional amounts as will result in the security holder’s receipt of such amounts as the security holder would have received had no such withholding or deduction been required.
The indenture provides that we will not have to pay additional amounts in certain specified circumstances, and that those circumstances may be modified or supplemented for different series of debt securities. Unless the prospectus supplement for a series of debt securities provides otherwise, debt securities issued using this prospectus will provide that we will not have to pay additional amounts if:
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the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for the holder’s connection to the jurisdiction in which we are resident for tax purposes, other than by merely holding the debt security or by receiving principal, premium, if any, or interest, if any, on the debt security, or enforcing the debt security. These connections include where the holder or related party: |
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is or has been a domiciliary, national or resident of such jurisdiction; |
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is or has been engaged in a trade or business in such jurisdiction; |
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has or had a permanent establishment in such jurisdiction; or |
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is or has been physically present in such jurisdiction. |
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the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for presentation of the debt security for payment, if presentation is required, more than 30 days after the security became due or payment was provided for; |
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the tax, levy, impost or other governmental charge is an estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge; |
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the tax, levy, impost or other governmental charge is payable in a manner that does not involve deduction or withholding from payments on or in respect of the relevant debt security; |
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the tax, levy, impost or other governmental charge would not have been imposed or withheld but for the failure of the holder or beneficial owner to comply with any certification, identification or other reporting requirement concerning the nationality, residence, identity or connection with any jurisdiction in which we are resident for tax purposes, as required by any treaty, statute, regulation or administrative practice of such jurisdiction as a condition to relief or exemption from such tax, levy, impost or other governmental charge; |
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the tax, levy, impost or other governmental charge is imposed on a payment to or for an individual and is required to be made pursuant to the European Union Directive 2003/48/EC on the taxation of savings or any other directive implementing the conclusions of the ECOFIN Council meeting of 26-27 November 2000 or any law implementing or complying with, or introduced in order to conform to, such Directive; |
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the holder would have been able to avoid such withholding or deduction by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form required by the relevant tax authority, a declarative, claim, certificate, document or other evidence establishing exemption therefrom; |
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the holder would have been able to avoid such withholding or deduction by presenting the relevant debt security to another paying agent in a Member State of the EU or elsewhere; and |
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the holder of the debt security is a fiduciary, partnership or a person other than the sole beneficial owner of any payment that would be required, by the laws of the jurisdiction in which we are resident for tax purposes, to be included in income, for tax purposes, of a beneficiary or settlor with respect to |
the fiduciary, a member of that partnership or a beneficial owner who would not have been entitled to the additional amounts had that beneficiary, settlor, partner or beneficial owner been the holder.
Mergers and Similar Events
We are generally permitted to consolidate or merge with another company or other entity that is organized under the laws of the United Kingdom, the United States or any other country which is a member of the Organization for Economic Cooperation and Development. We are also generally permitted to sell or convey our property as an entirety or substantially as an entirety to such other entity. Our ability to take some of these actions is restricted in the following ways:
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any entity succeeding us must assume our obligations in relation to the debt securities and under the indenture; |
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if the succeeding entity is not organized under the laws of the United Kingdom or a State of the United States, the succeeding entity’s assumption of our obligations in relation to the debt securities and under the indenture must include the obligation to pay any additional amounts as described under “— Payment of Additional Amounts”. |
It is possible that the merger, sale, or lease of all or substantially all of our assets would cause a principal property of ours or of a restricted subsidiary of ours or shares of stock or indebtedness of any of our restricted subsidiaries to become subject to a lien giving other lenders preferential rights in that property over holders of debt securities. We have promised to limit these preferential rights on our property, called liens, as discussed under “— Limitation on Liens”. If a merger or other transaction would create any impermissible liens on our property, we must grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
Optional Tax Redemption
We have the option to redeem the debt securities in the two situations described below. The redemption price for the debt securities, other than original issue discount debt securities, will be equal to the principal amount of the debt securities being redeemed plus accrued interest and any additional amounts due on the date fixed for redemption. The redemption price for original issue discount debt securities will be specified in the applicable prospectus supplement. We must give the security holder between 30 and 60 days’ notice before redeeming the debt securities.
The first situation is where, as a result of a change or amendment to any law or related regulation or ruling of the jurisdiction in which we are resident for tax purposes, or any change in an application or interpretation of such laws, regulations or rulings, or any change in application or interpretation of, or any execution of an amendment to, any treaty, we would have to pay additional amounts as described under “— Payment of Additional Amounts”.
This first situation applies only in the case of changes, amendments, applications, interpretations or executions that occur on or after the date specified in the prospectus supplement for the applicable series of debt securities. If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes, and the applicable date will be the date such entity became successor, rather than the date specified in the prospectus supplement.
The second situation is where our independent legal adviser has advised us that, as a result of action taken by a taxation authority of, or any action brought in a court of competent jurisdiction in, the jurisdiction in which we are resident for tax purposes, after the date specified in the prospectus supplement for the applicable series of debt securities, we would have to pay additional amounts as described under “— Payment of Additional Amounts” and the payment of such additional amounts cannot be avoided by the use of reasonable measures available to us. If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes and the applicable date will be the date such entity became our successor.
Covenants
Limitation on Liens
Some of our property and the property of our subsidiaries may be subject to a mortgage, pledge, assignment, charge or other legal mechanism that gives a lender preferential rights in that property over other lenders, including the security holder and the other direct holders of the debt securities, or over our general creditors if we fail to repay them. These preferential rights are generally called liens.
We undertake that we and certain of our subsidiaries, which we refer to as “restricted subsidiaries”, will not become obligated on any new debt for borrowed money that is secured by a lien on any principal property or on any shares of stock or indebtedness of any of our restricted subsidiaries unless we grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
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Restricted subsidiary means any wholly-owned subsidiary: |
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with substantially all of its property located within the UK or the US; and |
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which owns a principal property; |
but does not include any wholly-owned subsidiary principally engaged in leasing or in financing installment receivables or principally engaged in financing the operations of us and our consolidated subsidiaries.
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A wholly-owned subsidiary means any corporation in which control, directly or indirectly, of all of the stock with ordinary voting power to elect the board of directors of that corporation is owned by us, or by one or more of our wholly-owned subsidiaries or by us and one or more of our wholly-owned subsidiaries. |
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A subsidiary, with respect to any person, is any corporation in which that person owns or controls directly or indirectly at least a majority of stock with ordinary voting power to elect a majority of the board of directors. |
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Principal property means any manufacturing plant or facility or any research facility owned by us or any restricted subsidiary. A principal property must also be located within the UK or the US and have a gross book value (before deducting any depreciation reserve) exceeding 2% of our consolidated net tangible assets. Principal property does not include: |
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any plant or facility or research facility which in the opinion of our board of directors is not materially important to the total business conducted by us and our subsidiaries; or |
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any portion of a property described above which, in the opinion of our board of directors, is not materially important to the use or operation of the property. |
We do not need to comply with this restriction if the amount of all debt that would be secured by liens on our principal properties and the shares of stock or indebtedness of our restricted subsidiaries is no more than 15% of our consolidated net tangible assets.
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Our consolidated net tangible assets mean AstraZeneca PLC’s consolidated total assets, after deducting: |
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all liabilities due within one year (other than short-term borrowings and long-term debt due within one year); and |
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all goodwill, trade names, trademarks, patents and other similar types of intangible assets as shown on the audited consolidated balance sheet contained in the latest annual report to our shareholders. |
This restriction on liens does not apply to debt secured by a number of different types of liens. These types of liens include the following:
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any lien on property, shares of stock or indebtedness of any corporation existing at the time the corporation becomes a restricted subsidiary; |
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any lien on property or shares of stock existing at the time of acquisition of that property or those shares of stock, or to secure the payment of all or any part of the purchase price of that property or those shares of stock, or to secure any debt incurred before, at the time of, or within twelve months after, in the case of shares of stock, the acquisition of the shares of stock and, in the case of property, the later of the acquisition, completion of construction (including any improvements on an existing property) or commencement of the commercial operation of the property, where the debt is incurred to finance all or any part of the purchase price; |
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any lien securing debt owed to us or to any of our restricted subsidiaries by us or any of our restricted subsidiaries; |
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any lien existing at the date of the indenture; |
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any lien on a principal property to secure debt incurred to finance all or part of the cost of improving, constructing, altering or repairing any building, equipment or facilities or of any other improvements on all or any part of that principal property, if the debt is incurred before, during, or within twelve months after completing the improvement, construction, alteration or repair; |
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any lien on property owned or held by any corporation or on shares of stock or indebtedness of any corporation, where the lien existed either at the time the corporation is merged, consolidated or amalgamated with either us or a restricted subsidiary or at the time of a sale, lease or other disposition of all or substantially all of the property of a corporation to us or a restricted subsidiary; |
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any lien arising by operation of law and not securing amounts more than 90 days overdue or otherwise being contested in good faith; |
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any lien arising by operation of law over any credit balance or cash held in any account with a financial institution; |
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any rights of financial institutions to offset credit balances in connection with the operation of cash management programs established for our benefit and/or the benefit of any restricted subsidiary; |
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any lien incurred or deposits made in the ordinary course of business, including but not limited to: |
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any mechanics’, materialmen’s, carriers’, workmen’s, vendors’ or other similar liens; |
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any liens securing amounts in connection with workers’ compensation, unemployment insurance and other types of social security; and |
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any easements, rights-of-way, restrictions and other similar charges; |
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any liens incurred or deposits made securing the performance of tenders, bids, leases, statutory obligations, surety and appeal bonds, government contracts, performance and return of money bonds and other obligations of a similar nature incurred in the ordinary course of business; |
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any lien securing taxes or assessments or other applicable governmental charges or levies; |
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any extension, renewal or replacement or successive extensions, renewals or replacements, in whole or in part, of any lien included in the preceding paragraphs or of any of the debt secured under the preceding paragraphs, so long as the principal amount of debt secured does not exceed the principal amount of debt secured at the time of the extension, renewal or replacement, and that the extension, renewal or replacement lien is limited to all or any part of the same property or shares of stock that secured the lien extended, renewed or replaced (including improvements on that property), or property received or shares of stock issued in substitution or exchange; and |
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any lien in favor of us or any subsidiary of ours. |
The following types of transactions will not be deemed to create debt secured by a lien and, therefore, will also not be subject to the restriction on liens:
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any liens on property of ours or a restricted subsidiary in favor of the US or any State of the US, or the UK, or any other country, or any political subdivision of, or any department, agency or instrumentality of, these countries or states, to secure partial, progress, advance or other payments under provisions of any contract or statute including, but not limited to, liens to secure debt of pollution control or industrial revenue bond type, or to secure any indebtedness incurred for the purpose of financing all or any part of the purchase price or cost of construction of the property subject to these liens. |
Limitation on Sale and Lease-Back Transactions
Neither we nor any of our restricted subsidiaries will enter into any sale and lease-back transaction involving a principal property without complying with this covenant.
A sale and lease-back transaction is an arrangement between us or a restricted subsidiary and any person in which we or the restricted subsidiary leases back for a term of more than three years a principal property that we or the restricted subsidiary has sold or transferred to that person.
We and our restricted subsidiaries may enter into sale and lease-back transactions provided that the total amount of attributable debt attributable to all sale and lease-back transactions plus other debt of ours or any of our restricted subsidiaries that is secured by liens (but excluding debt secured by liens on property that we or a restricted subsidiary would be entitled to incur, assume or guarantee without equally and ratably securing the debt securities offered by this prospectus as described under “— Limitation on Liens” above) does not exceed 15% of consolidated net tangible assets.
This restriction does not apply to any sale and lease-back transaction if:
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we or the restricted subsidiary seeking to enter into the sale and lease-back could incur, assume or guarantee debt secured by a lien on the principal property to be leased without equally and ratably securing the debt securities offered by this prospectus as a result of one or more of the exceptions to the limitation on liens as described under “— Limitation on Liens” above; |
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within twelve months before or after the sale or transfer, regardless of whether the sale or transfer may have been made by us or a restricted subsidiary, we apply, an amount equal to the net proceeds of the sale or transfer (in the case of a sale or transfer for cash), or an amount equal to the fair value of the principal property so leased at the time of entering into the sale or transfer as determined by our board of directors (in the case of a sale or transfer otherwise than for cash), to |
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the retirement of indebtedness for money borrowed, incurred or assumed by us or any restricted subsidiary which matures at, or is extendible or renewable at the option of the obligor to, a date more than twelve months after the date of incurring, assuming or guaranteeing such debt, or |
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investment in any principal property or principal properties. |
This restriction on sale and lease-back transactions also does not apply to any transaction between us and a restricted subsidiary, or between restricted subsidiaries.
Attributable debt means the present value (discounted at a rate equal to the weighted average of the rate of interest on all securities then issued and outstanding under the indenture, compounded semi-annually) of our or a restricted subsidiary’s obligation for rental payments for the remaining term of any lease in a sale and lease-back transaction.
Default and Related Matters
Events of Default
A holder of debt securities of a particular series will have special rights if any event of default occurs with respect to that series and is not cured, as described later in this subsection.
What is an event of default? An event of default means any of the following:
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Interest — default for 30 days in the payment of any installment of interest on the series of debt securities; |
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Principal — default in the payment of all or any part of the principal of the series of debt securities when such principal becomes due and payable either at maturity, upon redemption, by acceleration or otherwise; |
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Sinking Fund Installment — default in the payment of any sinking fund installment as and when such installment becomes due and payable by the specific terms of the series of debt securities or beyond any period of grace; |
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Covenant — breach or default by us in the performance of a covenant or warranty in respect of the debt securities of the relevant series which has not been remedied for ninety days after we receive written notice of the default from the trustee or we and the trustee receive written notice of the default from the holders of at least 25% of the principal amount of the debt securities of all affected series; |
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Bankruptcy — certain events of bankruptcy, insolvency or reorganization affecting us; or |
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Other — any other event of default provided in any supplemental indenture or resolution of our board of directors under which a particular series is issued or in the form of security for such series. |
No event of default described in the provisions above with respect to a particular series of debt securities will necessarily constitute an event of default with respect to any other series of debt securities and the events of default for any specific series may be modified as described in the applicable prospectus supplement.
Remedies if an event of default occurs. If an event of default, other than a “Bankruptcy” default, has occurred (but only if, in the case of a “Covenant” default, the default has occurred for less than all series of debt securities then issued under the indenture and outstanding) and has not been cured, the trustee or the holders of at least 25% of the principal amount of debt securities of the affected series (each affected series voting as a separate class) may declare the principal amount (or, if the debt securities of a series are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all the debt securities of that series, together with any accrued interest, to be due and payable immediately. If an event of default has occurred under “Covenant” default with respect to all of the series of debt securities then issued under the indenture and outstanding, or under “Bankruptcy” default, and has not been cured, the trustee or the holders of at least 25% of the principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class) may declare the principal (or, if any debt securities are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all debt securities then issued under the indenture and outstanding, together with any accrued interest, to be due and payable immediately. This is called a declaration of acceleration of maturity. A declaration of acceleration of maturity may be canceled by the holders of at least a majority in principal amount of the debt securities of the affected series or by at least a majority in principal amount of all the debt securities then issued under the indenture and outstanding (voting as one class), as the case may be, if certain conditions are met.
Before a declaration of acceleration of maturity, past “Covenant” defaults that do not affect all series of debt securities then issued under the indenture and outstanding may be waived by the holders of a majority in principal amount of the debt securities then outstanding of each affected series (each such series voting as a separate class). Past “Covenant” defaults that affect all series of debt securities then issued under the indenture and outstanding and past “Bankruptcy” defaults may be waived by the holders of a majority in principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class). Default in the payment of principal of or interest on or any sinking fund installment of debt securities of any series or a covenant or provision of the indenture that cannot be modified or amended without the consent of the holder of each debt security affected may only be modified or amended with the consent of such holder.
Except in cases of default, where the trustee has some special duties, the trustee is not required to take any action under the indenture at the request of any holders unless the holders offer the trustee reasonable protection from expenses and liability. This protection is called an indemnity. If reasonable indemnity is provided, the holders of a majority in principal amount of the outstanding debt securities of the relevant series may, subject to certain limitations and conditions, direct the time, method and place of conducting any lawsuit or other formal legal action seeking any remedy available to the trustee.
These majority holders may also, subject to certain limitations and conditions, direct the trustee in performing any other action under the indenture.
Before the security holder bypasses the trustee and brings his or her own lawsuit or other formal legal action or takes other steps to enforce his or her rights or protects his or her interests relating to the debt securities, the following must occur:
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the security holder must give the trustee written notice that an event of default has occurred and remains uncured; |
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the holders of 25% in principal amount of all outstanding debt securities of the relevant series must make a written request that the trustee take action because of the default, and must offer reasonable indemnity to the trustee against the cost and other liabilities of taking that action; and |
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the trustee must have not taken action for 60 days after receipt of the above notice and offer of indemnity and the trustee has not received an inconsistent direction from the holders of a majority in principal amount of all outstanding debt securities of the relevant series during that period. |
These limitations do not apply to a suit instituted by the security holder for the enforcement of payment of the principal or interest on a debt security on or after the respective due dates.
We will file annually with the trustee on or before March 31 in each year a written statement of certain of our officers certifying that, to their knowledge, we have not defaulted on our covenants under the indenture or else specifying any default that exists.
For any series of debt securities that is a series of original issue discount securities the prospectus supplement will contain provisions for the acceleration of the maturity of a portion of the principal amount of such original issue discount securities.
Modification of the Indenture and Waiver
There are three types of changes we can make to the indenture and any series of the debt securities.
Changes not requiring approval. The first type of change does not require any vote by holders of debt securities. The security holder’s consent is not required to do any of the following:
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to transfer or pledge any property or assets to the trustee as security for any series of the debt securities; |
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to evidence the succession of any successor corporation to us as described under “Mergers and Similar Events” above; |
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to evidence the succession of any successor trustee under the indenture or to add to or change any provisions of the indenture as necessary to provide for the appointment of an additional trustee or trustees; |
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to add to our covenants or to add additional events of default for the benefit of the holders of any series of the debt securities; |
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to cure any ambiguity or to correct or supplement any provision of the indenture that may be defective or inconsistent with any other provision of the indenture; or |
· |
to make any other provisions with respect to matters or questions arising under the indenture as our board of directors may deem necessary or desirable and that shall not adversely affect the interests of holders of any series of the debt securities in any material respect. |
Changes requiring the approval of a majority of holders. The second type of change to the indenture and the debt securities requires a vote in favor by holders of debt securities owning at least a majority of the principal amount of all series of debt securities then outstanding and affected by such charge (each affected series voting as a separate class). In this manner, any provision of the indenture or any series of debt securities may be changed or eliminated unless the provision relates to a matter that requires the consent of each affected holder as discussed below.
Changes requiring the security holder’s approval. Third, there are changes that cannot be made to the security holder’s debt securities without the specific approval of each affected holder. The security holder’s consent is required before we could do any of the following:
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extend the final maturity of a debt security; |
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reduce the principal amount of a debt security; |
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reduce the rate or extend the time of payment of any interest on a debt security; |
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reduce any amount payable on redemption of a debt security; |
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reduce the amount of principal due and payable upon an acceleration of the maturity or provable in bankruptcy of a debt security issued at an original issue discount; |
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impair the security holder’s right to sue for payment; |
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impair any right of repayment at the option of the holder; |
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reduce the percentage of holders of debt securities whose consent is needed to modify or amend the indenture; or |
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change in any manner adverse to the holders of the debt securities our obligations relating to the payment of principal and interest, and sinking fund payments. |
Satisfaction, Discharge and Defeasance
We may terminate our repayment and obligations on the debt securities, when:
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we have paid or caused to be paid the principal of and interest, if any, then due and payable on all outstanding debt securities of any series; |
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we have delivered to the trustee for cancellation all outstanding debt securities of any series; or |
· |
all the outstanding debt securities of the series that have not been delivered to the trustee for cancellation have become or will become due and payable within one year and we have made arrangements satisfactory to the trustee for the giving of notice of redemption by the trustee in our name, and we have deposited with the trustee sufficient funds to pay and discharge the entire indebtedness on the series of debt securities to pay principal and interest, if any. |
We may legally release ourselves from any payment or other obligations on the debt securities, except for various obligations described below, if we, in addition to other actions, put in place the following arrangements for the security holder:
· |
we must deposit in trust for the security holder’s benefit and the benefit of all other direct holders of the debt securities a combination of money and government obligations that will generate enough cash to make interest, principal and any other payments on the debt securities on their various due dates; and |
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we must deliver to the trustee a legal opinion of our counsel to the effect that the holders of the debt securities of that series will not recognize gain or loss for US federal income tax purposes as a result of the defeasance and will be subject to the same federal income tax as would be the case if the defeasance did not occur. |
However, even if we take these actions, a number of our obligations relating to the debt securities will remain. These include the following obligations:
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to register the transfer and exchange of debt securities and our right of optional redemption, if any; |
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to replace mutilated, defaced, destroyed, lost or stolen debt securities; |
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to pay principal and interest, if any, on the original stated due dates and any remaining rights of the holders to receive sinking fund payments, if any, from funds deposited with the trustee; |
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immunities of the trustee; and |
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to hold money for payment in trust. |
Government obligation means securities that are:
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direct obligations of the US or any foreign government of a sovereign state for the payment of which is pledged by the full faith and credit of the US or such foreign government; or |
· |
obligations of an entity controlled or supervised by and acting as an agency or instrumentality of the US or any foreign government of a sovereign state the payment of which is unconditionally guaranteed as a full faith and credit obligation of the US or such foreign government; |
and are not callable or redeemable at the option of the issuer. Government obligation also includes:
· |
a depositary receipt issued by a bank or trust company as custodian for these government obligations, or specific payment of interest on or principal of these government obligations, held by such custodian for the account of the holder of a depositary receipt, provided that (except as required by law) such custodian is not authorized to make any deductions from the amount payable to the holder of such depositary receipt from any amount received by the custodian in respect of these government obligations, or the specific payment of interest on or principal of these government obligations, evidenced by such depositary receipt. |
Notices
We and the trustee will send notices only to direct holders, using their addresses registered in the trustee’s records.
Regardless of who acts as paying agent, all money that we pay to a paying agent that remains unclaimed at the end of two years after the amount is due to direct holders of debt securities will be repaid to us. After that two-year period, the security holder may look only to us for payment and not to the trustee, any other paying agent or anyone else.
Governing Law
The debt securities and the indenture will be governed by and construed in accordance with the laws of the State of New York.
Concerning the Trustee
The Bank of New York acts as the trustee with respect to certain debt securities of certain of our subsidiaries.
If an event of default occurs, or an event occurs that would be an event of default if the requirements for either giving us notice or our default having to exist for a specified time period were disregarded, the trustee may be considered to have a conflicting interest with respect to the debt securities or the indenture for purposes of the Trust
Indenture Act of 1939. In that case, the trustee may be required to resign as trustee under the applicable indenture and we would be required to appoint a successor trustee.
F. |
4.000% Notes due 2042 |
Prospectus Supplement:
DESCRIPTION OF NOTES
General
We offered $1,000,000,000 initial aggregate principal amount of 4.00% Notes due 2042 (the “2042 Notes” or the “notes”) The notes are governed by New York law.
The notes are unsecured, unsubordinated indebtedness of AstraZeneca PLC and rank equally with all of AstraZeneca PLC’s other unsecured and unsubordinated indebtedness from time to time outstanding.
There is no sinking fund for any series of notes. We have listed the notes on the Nasdaq Stock Market LLC.
Interest Payments and Maturity
For purposes of the description below, “business day” means any day which is not, in London, England or New York, New York, or the place of payment of amounts payable in respect of the notes, a Saturday, a Sunday, a legal holiday or a day on which banking institutions are authorized or obligated by law, regulation or executive order to close.
Maturity. The principal amount of 2042 Notes will mature and become due and payable, together with any accrued and unpaid interest, on September 18, 2042.
Interest Rate. The 2042 Notes will bear interest from their respective original issue date until their principal amount is paid or made available for payment, at a rate equal to 4.00% per annum, respectively, calculated on the basis of a 360-day year and twelve 30-day months.
Interest Payment Dates. Interest on the notes will be paid semi-annually in arrears on September 18 and March 18 of each year, commencing March 18, 2013 (each an “Interest Payment Date”). However, if an Interest Payment Date would fall on a day that is not a business day, the Interest Payment Date will be postponed to the next succeeding day that is a business day, but no additional interest shall be paid unless we fail to make payment on such date.
Interest Periods. The first interest period for the notes will be the period from and including the Issue date to but excluding the first Interest Payment Date. Thereafter, the interest periods for the notes will be the periods from and including the Interest Payment Dates to but excluding the immediately succeeding Interest Payment Date (together with the first interest period, each an “Interest Period”). The final Interest Period will be the period from and including the Interest Payment Date immediately preceding the maturity date to the maturity date.
Redemption
As explained below, under certain circumstances we may redeem the notes before they mature. This means that we may repay them early. The security holder has no right to require us to redeem the notes. Notes will stop bearing interest on the redemption date, even if the security holder does not collect his or her money. We will give notice to DTC of any redemption we propose to make at least 30 days, but no more than 60 days, before the redemption date. Notice by DTC to participating institutions and by these participants to street name holders of indirect interests in the notes will be made according to arrangements among them and may be subject to statutory or regulatory requirements.
Optional Redemption
We may redeem the notes, in whole or in part, at any time and from time to time at a redemption price equal to the greater of (i) 100% of the principal amount of the notes, and (ii) as determined by the quotation agent, the sum of the present values of the remaining scheduled payments of principal and interest on the notes to be redeemed (not including any portion of such payments of interest accrued as of the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the treasury rate plus the Make-Whole Spread (as set forth below) plus, in each case, accrued interest thereon to the date of redemption.
In connection with such optional redemption, the following defined terms apply:
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“Treasury rate” means, with respect to any redemption date, the rate per annum equal to the semiannual equivalent yield to maturity of the comparable treasury issue, assuming a price for the comparable treasury issue (expressed as a percentage of its principal amount) equal to the comparable treasury price for such redemption date. |
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“Comparable treasury issue” means the United States Treasury security selected by the quotation agent as having a maturity comparable to the remaining term of the notes to be redeemed that would be utilized, at the time of selection and in accordance with customary financial practice, in pricing new issues of corporate debt securities of comparable maturity to the remaining term of the notes. |
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“Comparable treasury price” means, with respect to any redemption date, (i) the average, as determined by the Quotation Agent, of the reference treasury dealer quotations for such redemption date, after excluding the highest and lowest such reference treasury dealer quotations, or (ii) if the trustee obtains fewer than three such reference treasury dealer quotations, the average of all such quotations. |
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“Quotation agent” means the reference treasury dealer appointed by us. |
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“Reference treasury dealer” means (i) each of Goldman, Sachs & Co., HSBC Securities (USA) Inc., J.P. Morgan Securities LLC, and Morgan Stanley & Co. LLC, and their respective successors or affiliates; provided, however, that if the foregoing shall cease to be a primary US government securities dealer in New York City (a “primary treasury dealer”), we shall substitute therefor another primary treasury dealer; and (ii) any other primary treasury dealer selected by us. |
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“Reference treasury dealer quotations” means, with respect to each reference treasury dealer and any redemption date, the average, as determined by the quotation agent, of the bid and asked prices for the comparable treasury issue (expressed in each case as a percentage of its principal amount) quoted in writing to the trustee by such reference treasury dealer at 5:00 p.m., Eastern Standard Time, on the third business day preceding such redemption date. |
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“Make-Whole Spread” means 20 basis points. |
Optional Tax Redemption
In the event of various tax law changes after the date of this prospectus supplement and other limited circumstances that require us to pay additional amounts, as described in the Base Prospectus under “Description of Debt Securities — Payment of Additional Amounts”, we may redeem all, but not less than all, of the notes at a price equal to 100% of the principal amount of the notes plus accrued interest to the date of redemption. This means we may repay the notes early. We discuss our ability to redeem the notes in greater detail under “Description of Debt Securities — Optional Tax Redemption”.
Further Issuances
We may, without the consent of the holders of notes, issue additional notes having the same ranking and same interest rate, maturity date, redemption terms and other terms as the notes described in this prospectus supplement. Any such additional notes, together with the notes offered by this prospectus supplement, will constitute a single series of securities under the Indenture. There is no limitation on the amount of notes or other debt securities that we may issue under such indenture.
We may offer additional notes with OID for US federal income tax purposes as part of a further issue. Purchasers of notes after the date of any further issue will not be able to differentiate between notes sold as part of such further issue and previously issued notes. If we were to issue additional notes with OID, purchasers of notes after such further issue may be required to accrue OID (or greater amounts of OID than they would otherwise have accrued) with respect to their notes. This may affect the price of outstanding notes following a further issue. Purchasers are advised to consult legal counsel with respect to the implications of any future decision by us to undertake a further issue of notes with OID.
Form, Denomination, Clearance and Settlement
We will issue the notes in fully registered form. The notes will be represented by one or more global securities registered in the name of a nominee of DTC. The security holder will hold beneficial interests in the notes through DTC in book-entry form. The notes will be issued in minimum denominations of $2,000 and in integral multiples of $1,000 in excess thereof. The underwriters expect to deliver the notes through the facilities of DTC on September 18, 2012. Indirect holders trading their beneficial interests in the notes through DTC must trade in DTC’s same-day funds settlement system and pay in immediately available funds. Secondary market trading through Euroclear and Clearstream, Luxembourg will occur in the ordinary way following the applicable rules and operating procedures of Euroclear and Clearstream, Luxembourg.
Payment of principal of and interest on the notes, so long as the notes are represented by global securities, as discussed below, will be made in immediately available funds. Beneficial interests in the global securities will trade in the same-day funds settlement system of DTC, and secondary market trading activity in such interests will therefore settle in same-day funds.
Payment of Additional Amounts
For more information on additional amounts and the situations in which AstraZeneca PLC may be required to pay additional amounts, see “Description of Debt Securities — Payment of Additional Amounts” in the Base Prospectus below.
Defeasance and Discharge
We may release ourselves from any payment or other obligations on the notes as described under “Description of Debt Securities — Satisfaction, Discharge and Defeasance” in the Base Prospectus.
Paying Agent
The principal corporate trust office of the trustee in The City of New York is designated as the principal paying agent. See “—Trustee” immediately below. We may at any time designate additional paying agents or rescind the designation of paying agents or approve a change in the office through which any paying agent acts.
Trustee
As a result of the transfer of JPMorgan Chase Bank’s corporate trust business to The Bank of New York Mellon (formerly known as The Bank of New York), effective October 1, 2006, The Bank of New York Mellon is the trustee under the Indenture. The trustee’s address is The Bank of New York Mellon, Corporate Trust Office, 101 Barclay Street, New York, NY 10286. The trustee will also serve as the paying agent for the notes. See “— Paying Agent” immediately above.
See “Description of Debt Securities — Concerning the Trustee” and “Description of Debt Securities — Default and Related Matters” in the Base Prospectus below for a description of the trustee’s procedures and remedies available in the event of default.
Base Prospectus:
DESCRIPTION OF DEBT SECURITIES
We may issue debt securities using this prospectus. As required by US federal law for all publicly offered corporate bonds and notes, the debt securities are governed by a document called an indenture. The indenture relating to the debt securities issued by us is a contract, dated as of April 1, 2004, between AstraZeneca PLC and JPMorgan Chase Bank, as trustee. As a result of the transfer of JPMorgan Chase Bank’s corporate trust business to The Bank of New York Mellon (formerly known as The Bank of New York) effective October 1, 2006, The Bank of New York Mellon is the trustee under the indenture. See “— The Trustee” below.
In this description “the security holder” means direct holders and not street name or other indirect holders of securities. Indirect holders should read the section “Legal Ownership — Street Names and Other Indirect Holders” above.
General
This section summarizes the material provisions of the indenture and the debt securities. Because it is a summary, it does not describe every aspect of the indenture or the debt securities. This summary is subject to and qualified in its entirety by reference to all of the indenture provisions, including some of the terms used and defined in the indenture. We describe the meaning of only the more important terms in this prospectus. We also include references in parentheses to some sections of the indenture. Whenever we refer to particular sections or defined terms of the indenture in this prospectus or in the prospectus supplement, those sections or defined terms are incorporated by reference here or in the prospectus supplement. This summary is also subject to and qualified by reference to the description of the particular terms of the security holder’s series of debt securities described in the prospectus supplement.
The indenture and its associated documents contain the full legal text of the matters described in this section. The indenture and the debt securities are governed by New York law. The indenture is an exhibit incorporated by reference into this prospectus.
The debt securities are unsecured obligations of AstraZeneca PLC. The debt securities will rank equally in right of payment with all of our other unsecured and unsubordinated indebtedness except for indebtedness that is preferred under applicable law.
The Trustee
The Bank of New York Mellon (as successor trustee to JPMorgan Chase Bank) is the trustee under the indenture. As trustee, it has two main roles:
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first, it can enforce the security holder’s rights against us if we default on debt securities issued under the indenture. There are some limitations on the extent to which the trustee may act on the security holder’s behalf, described under “Defaults and Related Matters — Remedies if an event of default occurs” below; and |
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second, the trustee performs administrative duties for us, such as sending the security holder interest payments and notices. |
Types of Debt Securities
The indenture does not limit the amount of debt securities that we can issue. It provides that debt securities may be issued in one or more series up to the aggregate principal amount as we authorize from time to time. All debt securities of one series need not be issued at the same time and we may reopen any series, without the consent of a holder of that series, to issue additional debt securities of the same series.
The prospectus supplement relating to a series of debt securities will describe the following terms of the series:
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the title of the series of debt securities; |
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the aggregate principal amount of debt securities and any limit on the aggregate principal amount of the series of debt securities; |
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any stock exchange on which we will list the debt securities; |
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the date or dates on which we will repay the principal amount of the series of debt securities or the method by which the date or dates will be determined; |
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any rate or rates at which the series of debt securities will bear interest or the method by which the interest rate or rates will be determined; |
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the date or dates from which any interest on the series of debt securities will accrue, the dates on which interest will be payable and the record dates for interest payments or the method by which such date or dates will be determined and the method by which interest will be calculated if different to a 360-day year of twelve 30-day months; |
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the place or places where the principal and any interest on debt securities will be payable if other than the corporate trust office of the trustee in New York, New York; |
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the price or prices at which, the period or periods within which, the currency or currencies, currency unit or composite currency in which, and the terms and conditions upon which we may redeem the series of debt securities in whole or in part; |
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any right or obligation to redeem, repay or purchase the debt securities as a result of any sinking fund or similar provisions, or at the option of the holder of the debt securities and the period or periods within which, the price or prices at which and every other term and condition upon which the debt securities will be redeemed, repaid or purchased; |
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the denominations in which debt securities of the series are issuable, if other than denominations of $1,000 and any multiple of $1,000; |
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the portion of the principal amount of the series of debt securities payable if an acceleration of the maturity of the debt securities is declared, if other than the principal amount; |
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the currency, including any composite currency, of payment of the principal, premium, if any, and interest on the series of debt securities if other than US dollars; |
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whether we or a holder of debt securities may elect to have the principal, premium, if any, or interest on the series of debt securities paid in a currency or composite currency other than the currency in which the debt securities are stated to be payable, and if so, any election period and the terms and conditions governing such an election; |
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whether we will be required to pay additional amounts for withholding taxes or other governmental charges and, if applicable, a related right to an optional tax redemption for such a series; |
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any index used to determine the amount of payment of principal, premium, if any, and interest on the series of debt securities and how these amounts will be determined if they are not fixed when the debt securities are issued; |
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the forms of the series of debt securities; |
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the applicability of the provisions described later under “— Satisfaction, Discharge and Defeasance”; |
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any authenticating or paying agents, transfer agents or registrars or any other agents acting in connection with the debt securities other than the trustee; |
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if applicable, a discussion of any additional material US federal income and UK tax considerations; and |
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any other special features of the series of debt securities. |
We may issue the debt securities as original issue discount securities, which are debt securities offered and sold at a substantial discount to their stated principal amount.
Overview of the Remainder of this Description
The remainder of this description summarizes:
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Additional mechanics relevant to the debt securities under normal circumstances, such as how the security holder transfers ownership and where we make payments. |
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The security holder’s right to receive payment of additional amounts due to changes in the tax withholding requirements of various jurisdictions. |
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The security holder’s rights under several special situations, such as if we merge with another company or if we want to redeem the debt securities for tax reasons. |
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Covenants contained in the indenture that restrict our ability to incur liens and undertake sale and leaseback transactions. A particular series of debt securities may have different covenants. |
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The security holder’s rights if we default. |
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The security holder’s rights if we want to modify the indenture. |
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Our relationship with the trustee. |
Additional Mechanics
Exchange and Transfer
Unless otherwise stated in the prospectus supplement, the debt securities will be issued only in fully registered form without interest coupons in denominations of $1,000 or whole multiples of $1,000. The security holder may have his or her debt securities broken into more debt securities of smaller $1,000 denominations or combined into fewer debt securities of larger $1,000 denominations, as long as the total principal amount is not changed. This is called an exchange.
The security holder may exchange or transfer registered debt securities at the office of the trustee. The trustee acts as our agent for registering debt securities in the names of holders and for transferring registered debt securities. We may change this appointment to another entity or perform the service ourselves. The entity performing the role of maintaining the list of registered holders is called the security registrar. It will also register transfers of the registered debt securities.
The security holder may not exchange his or her registered debt securities for bearer securities.
There will be no service charge for any exchange or registration of transfer of the debt securities, but we may require payment of an amount sufficient to cover any tax or other governmental charge imposed in connection with any exchange or registration of transfer.
The transfer or exchange of a registered debt security may be made only if the security registrar is satisfied with the security holder’s proof of ownership.
If the debt securities are redeemable and we redeem less than all of the debt securities of a particular series, we may block the transfer or exchange of debt securities during a specified period of time in order to freeze the list of holders to prepare the mailing. The period begins 15 days before the day we first mail the notice of redemption and ends on the day of that mailing. We may also refuse to register transfers or exchanges of debt securities selected or called for redemption. However, we will continue to permit transfers and exchanges of the unredeemed portion of any security being partially redeemed.
Payment and Paying Agents
We will pay interest to the security holder if he or she is a direct holder of debt securities at the close of business on a particular day in advance of each due date for interest, even if the security holder no longer owns the security on the interest due date. That particular day, usually about two weeks in advance of the interest due date, is called the record date and is stated in the prospectus supplement.
Unless otherwise specified in the prospectus supplement, we will pay interest, principal and any other money due on debt securities in registered form at the corporate trust office of The Bank of New York Mellon (as successor paying agent to JPMorgan Chase Bank) in the Borough of Manhattan, The City and State of New York as paying agent for the debt securities. That office is located at The Bank of New York Mellon, 101 Barclay Street, New York, New York 10286. At our option, we may pay interest on any debt securities by check mailed to the registered holders.
Some of the debt securities may be denominated, and payments may be made, in currencies other than US dollars or in composite currencies. A summary of any special considerations which apply to these debt securities is in the applicable prospectus supplement.
Street name and other indirect holders should consult their banks or brokers for information on how they will receive payments.
We may arrange for additional payment offices, or may cancel or change these offices, including our use of the trustee’s corporate trust office. These offices are called paying agents. We may also choose to act as our own paying agent, but must always maintain a paying agency in the Borough of Manhattan, The City and State of New York. Whenever there are changes in the paying agents for any particular series of debt securities we must notify the trustee.
Payment of Additional Amounts
We agree that any amounts to be paid by us under any series of debt securities of principal, premium and interest in respect of the debt securities will be paid without deduction or withholding for, any and all present and future taxes, levies, duties, assessments, imposts or other governmental charges of whatever nature imposed, assessed, levied or collected by or for the account of the government of any jurisdiction in which we are resident for tax purposes (at the time of the issuance, the UK) or any political subdivision or taxing authority of such jurisdiction, unless such withholding or deduction is required by law. If such deduction or withholding is at any time required, we will (subject to compliance by the security holder with any relevant administrative requirements) pay such additional amounts as will result in the receipt of such amounts as would have been received by the holder had no such withholding or deduction been required.
The indenture provides that we will not have to pay additional amounts in certain specified circumstances, and that those circumstances may be modified or supplemented for different series of debt securities. Unless the prospectus supplement for a series of debt securities provides otherwise, debt securities issued using this prospectus will provide that we will not have to pay additional amounts if:
· |
the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for the holder’s connection to the jurisdiction in which we are resident for tax purposes, other than by merely holding the debt security or by receiving principal, premium, if any, or interest, if any, on the debt security, or enforcing the debt security. These connections include where the holder or related party: |
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is or has been a domiciliary, national or resident of such jurisdiction; |
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is or has been engaged in a trade or business in such jurisdiction; |
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has or had a permanent establishment in such jurisdiction; or |
· |
is or has been physically present in such jurisdiction. |
· |
the tax, levy, impost or other governmental charge would not have been imposed, assessed, levied or collected but for presentation of the debt security for payment, if presentation is required, more than 30 days after the security became due or payment was provided for; |
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the tax, levy, impost or other governmental charge is an estate, inheritance, gift, sale, transfer, personal property or similar tax, levy, impost or other governmental charge; |
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the tax, levy, impost or other governmental charge is payable in a manner that does not involve deduction or withholding from payments on or in respect of the relevant debt security; |
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the tax, levy, impost or other governmental charge would not have been imposed or withheld but for the failure of the holder or beneficial owner to comply with any certification, identification or other reporting requirement concerning the nationality, residence, identity or connection with any jurisdiction in which we are resident for tax purposes, as required by any treaty, statute, regulation or administrative practice of such jurisdiction as a condition to relief or exemption from such tax, levy, impost or other governmental charge; |
· |
the tax, levy, impost or other governmental charge is imposed on a payment to or for an individual and is required to be made pursuant to the European Union Directive 2003/48/EC on the taxation of savings or any other directive implementing the conclusions of the ECOFIN Council meeting of 26-27 |
November 2000 or any law implementing or complying with, or introduced in order to conform to, such Directive;
· |
the holder would have been able to avoid such withholding or deduction by authorizing the paying agent to report information in accordance with the procedure laid down by the relevant tax authority or by producing, in the form required by the relevant tax authority, a declarative, claim, certificate, document or other evidence establishing exemption therefrom; |
· |
the holder would have been able to avoid such withholding or deduction by presenting the relevant debt security to another paying agent in a Member State of the EU or elsewhere; or |
· |
the holder of the debt security is a fiduciary, partnership or a person other than the sole beneficial owner of any payment that would be required, by the laws of the jurisdiction in which we are resident for tax purposes, to be included in income, for tax purposes, of a beneficiary or settlor with respect to the fiduciary, a member of that partnership or a beneficial owner who would not have been entitled to the additional amounts had that beneficiary, settlor, partner or beneficial owner been the holder. |
Mergers and Similar Events
We are generally permitted to consolidate or merge with another company or other entity that is organized under the laws of the United Kingdom, the United States or any other country which is a member of the Organization for Economic Cooperation and Development. We are also generally permitted to sell or convey our property as an entirety or substantially as an entirety to such other entity. Our ability to take some of these actions is restricted in the following ways:
· |
any entity succeeding us must assume our obligations in relation to the debt securities and under the indenture; |
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if the succeeding entity is not organized under the laws of the United Kingdom or a State of the United States, the succeeding entity’s assumption of our obligations in relation to the debt securities and under the indenture must include the obligation to pay any additional amounts as described under “— Payment of Additional Amounts”. |
It is possible that the merger, sale, or lease of all or substantially all of our assets would cause a principal property of ours or of a restricted subsidiary of ours or shares of stock or indebtedness of any of our restricted subsidiaries to become subject to a lien giving other lenders preferential rights in that property over holders of debt securities. We have promised to limit these preferential rights on our property, called liens, as discussed under “— Limitation on Liens”. If a merger or other transaction would create any impermissible liens on our property, we must grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
Optional Tax Redemption
We have the option to redeem the debt securities in the two situations described below. The redemption price for the debt securities, other than original issue discount debt securities, will be equal to the principal amount of the debt securities being redeemed plus accrued interest and any additional amounts due on the date fixed for redemption. The redemption price for original issue discount debt securities will be specified in the applicable prospectus supplement. We must give the security holder between 30 and 60 days’ notice before redeeming the debt securities.
The first situation is where, as a result of a change or amendment to any law or related regulation or ruling of the jurisdiction in which we are resident for tax purposes, or any change in an application or interpretation of such laws, regulations or rulings, or any change in application or interpretation of, or any execution of an amendment to, any treaty, we would have to pay additional amounts as described under “— Payment of Additional Amounts”.
This first situation applies only in the case of changes, amendments, applications, interpretations or executions that occur on or after the date specified in the prospectus supplement for the applicable series of debt securities. If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes, and the applicable date will be the date such entity became successor, rather than the date specified in the prospectus supplement.
The second situation is where our independent legal adviser has advised us that, as a result of action taken by a taxation authority of, or any action brought in a court of competent jurisdiction in, the jurisdiction in which we are resident for tax purposes, after the date specified in the prospectus supplement for the applicable series of debt securities, we would have to pay additional amounts as described under “— Payment of Additional Amounts” and the payment of such additional amounts cannot be avoided by the use of reasonable measures available to us. If we are succeeded by another entity, the applicable jurisdiction will be the jurisdiction in which such successor is resident for tax purposes, rather than the jurisdiction in which we are resident for tax purposes and the applicable date will be the date such entity became our successor.
Covenants
Limitation on Liens
Some of our property and the property of our subsidiaries may be subject to a mortgage, pledge, assignment, charge or other legal mechanism that gives a lender preferential rights in that property over other lenders, including the security holder and the other direct holders of the debt securities, or over our general creditors if we fail to repay them. These preferential rights are generally called liens.
We undertake that we and certain of our subsidiaries, which we refer to as “restricted subsidiaries”, will not become obligated on any new debt for borrowed money that is secured by a lien on any principal property or on any shares of stock or indebtedness of any of our restricted subsidiaries unless we grant an equivalent or higher-ranking lien on the same property to the security holder and the other direct holders of the debt securities.
· |
Restricted subsidiary means any wholly-owned subsidiary: |
· |
with substantially all of its property located within the UK or the US; and |
· |
which owns a principal property; |
but does not include any wholly-owned subsidiary principally engaged in leasing or in financing installment receivables or principally engaged in financing the operations of us and our consolidated subsidiaries.
· |
A wholly-owned subsidiary means any corporation in which control, directly or indirectly, of all of the stock with ordinary voting power to elect the board of directors of that corporation is owned by us, or by one or more of our wholly-owned subsidiaries or by us and one or more of our wholly-owned subsidiaries. |
· |
A subsidiary, with respect to any person, is any corporation in which that person owns or controls directly or indirectly at least a majority of stock with ordinary voting power to elect a majority of the board of directors. |
· |
Principal property means any manufacturing plant or facility or any research facility owned by us or any restricted subsidiary. A principal property must also be located within the UK or the US and have a gross book value (before deducting any depreciation reserve) exceeding 2% of our consolidated net tangible assets. Principal property does not include: |
· |
any plant or facility or research facility which in the opinion of our board of directors is not materially important to the total business conducted by us and our subsidiaries; or |
· |
any portion of a property described above which, in the opinion of our board of directors, is not materially important to the use or operation of the property. |
We do not need to comply with this restriction if the amount of all debt that would be secured by liens on our principal properties and the shares of stock or indebtedness of our restricted subsidiaries is no more than 15% of our consolidated net tangible assets.
· |
Our consolidated net tangible assets mean AstraZeneca PLC’s consolidated total assets, after deducting: |
· |
all liabilities due within one year (other than short-term borrowings and long-term debt due within one year); and |
· |
all goodwill, trade names, trademarks, patents and other similar types of intangible assets as shown on the audited consolidated balance sheet contained in the latest annual report to our shareholders. |
This restriction on liens does not apply to debt secured by a number of different types of liens. These types of liens include the following:
· |
any lien on property, shares of stock or indebtedness of any corporation existing at the time the corporation becomes a restricted subsidiary; |
· |
any lien on property or shares of stock existing at the time of acquisition of that property or those shares of stock, or to secure the payment of all or any part of the purchase price of that property or those shares of stock, or to secure any debt incurred before, at the time of, or within twelve months after, in the case of shares of stock, the acquisition of the shares of stock and, in the case of property, the later of the acquisition, completion of construction (including any improvements on an existing property) or commencement of the commercial operation of the property, where the debt is incurred to finance all or any part of the purchase price; |
· |
any lien securing debt owed to us or to any of our restricted subsidiaries by us or any of our restricted subsidiaries; |
· |
any lien existing at the date of the indenture; |
· |
any lien on a principal property to secure debt incurred to finance all or part of the cost of improving, constructing, altering or repairing any building, equipment or facilities or of any other improvements on all or any part of that principal property, if the debt is incurred before, during, or within twelve months after completing the improvement, construction, alteration or repair; |
· |
any lien on property owned or held by any corporation or on shares of stock or indebtedness of any corporation, where the lien existed either at the time the corporation is merged, consolidated or amalgamated with either us or a restricted subsidiary or at the time of a sale, lease or other disposition of all or substantially all of the property of a corporation to us or a restricted subsidiary; |
· |
any lien arising by operation of law and not securing amounts more than 90 days overdue or otherwise being contested in good faith; |
· |
any lien arising by operation of law over any credit balance or cash held in any account with a financial institution; |
· |
any rights of financial institutions to offset credit balances in connection with the operation of cash management programs established for our benefit and/or the benefit of any restricted subsidiary; |
· |
any lien incurred or deposits made in the ordinary course of business, including but not limited to: |
· |
any mechanics’, materialmen’s, carriers’, workmen’s, vendors’ or other similar liens; |
· |
any liens securing amounts in connection with workers’ compensation, unemployment insurance and other types of social security; and |
· |
any easements, rights-of-way, restrictions and other similar charges; |
· |
any liens incurred or deposits made securing the performance of tenders, bids, leases, statutory obligations, surety and appeal bonds, government contracts, performance and return of money bonds and other obligations of a similar nature incurred in the ordinary course of business; |
· |
any lien securing taxes or assessments or other applicable governmental charges or levies; |
· |
any extension, renewal or replacement or successive extensions, renewals or replacements, in whole or in part, of any lien included in the preceding paragraphs or of any of the debt secured under the preceding paragraphs, so long as the principal amount of debt secured does not exceed the principal amount of debt secured at the time of the extension, renewal or replacement, and that the extension, renewal or replacement lien is limited to all or any part of the same property or shares of stock that secured the lien extended, renewed or replaced (including improvements on that property), or property received or shares of stock issued in substitution or exchange; and |
· |
any lien in favor of us or any subsidiary of ours. |
The following types of transactions will not be deemed to create debt secured by a lien and, therefore, will also not be subject to the restriction on liens:
· |
any liens on property of ours or a restricted subsidiary in favor of the US or any State of the US, or the UK, or any other country, or any political subdivision of, or any department, agency or instrumentality of, these countries or states, to secure partial, progress, advance or other payments under provisions of any contract or statute including, but not limited to, liens to secure debt of pollution control or industrial revenue bond type, or to secure any indebtedness incurred for the purpose of financing all or any part of the purchase price or cost of construction of the property subject to these liens. |
Limitation on Sale and Lease-Back Transactions
Neither we nor any of our restricted subsidiaries will enter into any sale and lease-back transaction involving a principal property without complying with this covenant.
A sale and lease-back transaction is an arrangement between us or a restricted subsidiary and any person in which we or the restricted subsidiary leases back for a term of more than three years a principal property that we or the restricted subsidiary has sold or transferred to that person.
We and our restricted subsidiaries may enter into sale and lease-back transactions provided that the total amount of attributable debt attributable to all sale and lease-back transactions plus other debt of ours or any of our restricted subsidiaries that is secured by liens (but excluding debt secured by liens on property that we or a restricted subsidiary would be entitled to incur, assume or guarantee without equally and ratably securing the debt securities offered by this prospectus as described under “— Limitation on Liens” above) does not exceed 15% of consolidated net tangible assets.
This restriction does not apply to any sale and lease-back transaction if:
· |
we or the restricted subsidiary seeking to enter into the sale and lease-back could incur, assume or guarantee debt secured by a lien on the principal property to be leased without equally and ratably securing the debt securities offered by this prospectus as a result of one or more of the exceptions to the limitation on liens as described under “— Limitation on Liens” above; |
· |
within twelve months before or after the sale or transfer, regardless of whether the sale or transfer may have been made by us or a restricted subsidiary, we apply, an amount equal to the net proceeds of the sale or transfer (in the case of a sale or transfer for cash), or an amount equal to the fair value of the principal property so leased at the time of entering into the sale or transfer as determined by our board of directors (in the case of a sale or transfer otherwise than for cash), to |
· |
the retirement of indebtedness for money borrowed, incurred or assumed by us or any restricted subsidiary which matures at, or is extendible or renewable at the option of the obligor to, a date more than twelve months after the date of incurring, assuming or guaranteeing such debt, or |
· |
investment in any principal property or principal properties. |
This restriction on sale and lease-back transactions also does not apply to any transaction between us and a restricted subsidiary, or between restricted subsidiaries.
Attributable debt means the present value (discounted at a rate equal to the weighted average of the rate of interest on all securities then issued and outstanding under the indenture, compounded semi-annually) of our or a restricted subsidiary’s obligation for rental payments for the remaining term of any lease in a sale and lease-back transaction.
Default and Related Matters
Events of Default
A holder of debt securities of a particular series will have special rights if any event of default occurs with respect to that series and is not cured, as described later in this subsection.
What is an event of default? An event of default means any of the following:
· |
Interest — default for 30 days in the payment of any installment of interest on the series of debt securities; |
· |
Principal — default in the payment of all or any part of the principal of the series of debt securities when such principal becomes due and payable either at maturity, upon redemption, by acceleration or otherwise; |
· |
Sinking Fund Installment — default in the payment of any sinking fund installment as and when such installment becomes due and payable by the specific terms of the series of debt securities or beyond any period of grace; |
· |
Covenant — breach or default by us in the performance of a covenant or warranty in respect of the debt securities of the relevant series which has not been remedied for ninety days after we receive written notice of the default from the trustee or we and the trustee receive written notice of the default from the holders of at least 25% of the principal amount of the debt securities of all affected series; |
· |
Bankruptcy — certain events of bankruptcy, insolvency or reorganization affecting us; or |
· |
Other — any other event of default provided in any supplemental indenture or resolution of our board of directors under which a particular series is issued or in the form of security for such series. |
No event of default described in the provisions above with respect to a particular series of debt securities will necessarily constitute an event of default with respect to any other series of debt securities and the events of default for any specific series may be modified as described in the applicable prospectus supplement.
Remedies if an event of default occurs. If an event of default, other than a “Bankruptcy” default, has occurred (but only if, in the case of a “Covenant” default, the default has occurred for less than all series of debt securities then issued under the indenture and outstanding) and has not been cured, the trustee or the holders of at least 25% of the principal amount of debt securities of the affected series (each affected series voting as a separate class) may declare the principal amount (or, if the debt securities of a series are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all the debt securities of that series, together with any accrued interest, to be due and payable immediately. If an event of default has occurred under “Covenant” default with respect to all of the series of debt securities then issued under the indenture and outstanding, or under “Bankruptcy” default, and has not been cured, the trustee or the holders of at least 25% of the principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class) may declare the principal (or, if any debt securities are original issue discount securities, that portion of the principal amount as may be specified in the terms of that series) of all debt securities then issued under the indenture and outstanding, together with any accrued interest, to be due and payable immediately. This is called a declaration of acceleration of maturity. A declaration of acceleration of maturity may be canceled by the holders of at least a majority in principal amount of the debt securities of the affected series or by at least a majority in principal amount of all the debt securities then issued under the indenture and outstanding (voting as one class), as the case may be, if certain conditions are met.
Before a declaration of acceleration of maturity, past “Covenant” defaults that do not affect all series of debt securities then issued under the indenture and outstanding may be waived by the holders of a majority in principal amount of the debt securities then outstanding of each affected series (each such series voting as a separate class).
Past “Covenant” defaults that affect all series of debt securities then issued under the indenture and outstanding and past “Bankruptcy” defaults may be waived by the holders of a majority in principal amount of all the debt securities then issued under the indenture and outstanding (treated as one class). Default in the payment of principal of or interest on or any sinking fund installment of debt securities of any series or a covenant or provision of the indenture that cannot be modified or amended without the consent of the holder of each debt security affected may only be modified or amended with the consent of such holder.
Except in cases of default, where the trustee has some special duties, the trustee is not required to take any action under the indenture at the request of any holders unless the holders offer the trustee reasonable protection from expenses and liability. This protection is called an indemnity. If reasonable indemnity is provided, the holders of a majority in principal amount of the outstanding debt securities of the relevant series may, subject to certain limitations and conditions, direct the time, method and place of conducting any lawsuit or other formal legal action seeking any remedy available to the trustee. These majority holders may also, subject to certain limitations and conditions, direct the trustee in performing any other action under the indenture.
Before the security holder bypasses the trustee and brings his or her own lawsuit or other formal legal action or takes other steps to enforce his or her rights or protects his or her interests relating to the debt securities, the following must occur:
· |
the security holder must give the trustee written notice that an event of default has occurred and remains uncured; |
· |
the holders of 25% in principal amount of all outstanding debt securities of the relevant series must make a written request that the trustee take action because of the default, and must offer reasonable indemnity to the trustee against the cost and other liabilities of taking that action; and |
· |
the trustee must have not taken action for 60 days after receipt of the above notice and offer of indemnity and the trustee has not received an inconsistent direction from the holders of a majority in principal amount of all outstanding debt securities of the relevant series during that period. |
These limitations do not apply to a suit instituted by the security holder for the enforcement of payment of the principal or interest on a debt security on or after the respective due dates.
We will file annually with the trustee on or before March 31 in each year a written statement of certain of our officers certifying that, to their knowledge, we have not defaulted on our covenants under the indenture or else specifying any default that exists.
For any series of debt securities that is a series of original issue discount securities the prospectus supplement will contain provisions for the acceleration of the maturity of a portion of the principal amount of such original issue discount securities.
Modification of the Indenture and Waiver
There are three types of changes we can make to the indenture and any series of the debt securities.
Changes not requiring approval. The first type of change does not require any vote by holders of debt securities. The security holder’s consent is not required to do any of the following:
· |
to transfer or pledge any property or assets to the trustee as security for any series of the debt securities; |
· |
to evidence the succession of any successor corporation to us as described under “Mergers and Similar Events” above; |
· |
to evidence the succession of any successor trustee under the indenture or to add to or change any provisions of the indenture as necessary to provide for the appointment of an additional trustee or trustees; |
· |
to add to our covenants or to add additional events of default for the benefit of the holders of any series of the debt securities; |
· |
to cure any ambiguity or to correct or supplement any provision of the indenture that may be defective or inconsistent with any other provision of the indenture; or |
· |
to make any other provisions with respect to matters or questions arising under the indenture as our board of directors may deem necessary or desirable and that shall not adversely affect the interests of holders of any series of the debt securities in any material respect. |
Changes requiring the approval of a majority of holders. The second type of change to the indenture and the debt securities requires a vote in favor by holders of debt securities owning at least a majority of the principal amount of all series of debt securities then outstanding and affected by such charge (each affected series voting as a separate class). In this manner, any provision of the indenture or any series of debt securities may be changed or eliminated unless the provision relates to a matter that requires the consent of each affected holder as discussed below.
Changes requiring the security holder’s approval. Third, there are changes that cannot be made to the security holder’s debt securities without the specific approval of each affected holder. The security holder’s consent is required before we could do any of the following:
· |
extend the final maturity of a debt security; |
· |
reduce the principal amount of a debt security; |
· |
reduce the rate or extend the time of payment of any interest on a debt security; |
· |
reduce any amount payable on redemption of a debt security; |
· |
reduce the amount of principal due and payable upon an acceleration of the maturity or provable in bankruptcy of a debt security issued at an original issue discount; |
· |
impair the security holder’s right to sue for payment; |
· |
impair any right of repayment at the option of the holder; |
· |
reduce the percentage of holders of debt securities whose consent is needed to modify or amend the indenture; or |
· |
change in any manner adverse to the holders of the debt securities our obligations relating to the payment of principal and interest, and sinking fund payments. |
Satisfaction, Discharge and Defeasance
We may terminate our repayment and obligations on the debt securities, when:
· |
we have paid or caused to be paid the principal of and interest, if any, then due and payable on all outstanding debt securities of any series; |
· |
we have delivered to the trustee for cancellation all outstanding debt securities of any series; or |
· |
all the outstanding debt securities of the series that have not been delivered to the trustee for cancellation have become or will become due and payable within one year and we have made arrangements satisfactory to the trustee for the giving of notice of redemption by the trustee in our name, and we have deposited with the trustee sufficient funds to pay and discharge the entire indebtedness on the series of debt securities to pay principal and interest, if any. |
We may legally release ourselves from any payment or other obligations on the debt securities, except for various obligations described below, if we, in addition to other actions, put in place the following arrangements for the security holder:
· |
we must deposit in trust for the security holder’s benefit and the benefit of all other direct holders of the debt securities a combination of money and government obligations that will generate enough cash to make interest, principal and any other payments on the debt securities on their various due dates; and |
· |
we must deliver to the trustee a legal opinion of our counsel to the effect that the holders of the debt securities of that series will not recognize gain or loss for US federal income tax purposes as a result of the defeasance and will be subject to the same federal income tax as would be the case if the defeasance did not occur. |
However, even if we take these actions, a number of our obligations relating to the debt securities will remain. These include the following obligations:
· |
to register the transfer and exchange of debt securities and our right of optional redemption, if any; |
· |
to replace mutilated, defaced, destroyed, lost or stolen debt securities; |
· |
to pay principal and interest, if any, on the original stated due dates and any remaining rights of the holders to receive sinking fund payments, if any, from funds deposited with the trustee; |
· |
immunities of the trustee; and |
· |
to hold money for payment in trust. |
Government obligation means securities that are:
· |
direct obligations of the US or any foreign government of a sovereign state for the payment of which is pledged by the full faith and credit of the US or such foreign government; or |
· |
obligations of an entity controlled or supervised by and acting as an agency or instrumentality of the US or any foreign government of a sovereign state the payment of which is unconditionally guaranteed as a full faith and credit obligation of the US or such foreign government; |
and are not callable or redeemable at the option of the issuer. Government obligation also includes:
· |
a depositary receipt issued by a bank or trust company as custodian for these government obligations, or specific payment of interest on or principal of these government obligations, held by such custodian for the account of the holder of a depositary receipt, provided that (except as required by law) such custodian is not authorized to make any deductions from the amount payable to the holder of such depositary receipt from any amount received by the custodian in respect of these government obligations, or the specific payment of interest on or principal of these government obligations, evidenced by such depositary receipt. |
Notices
We and the trustee will send notices only to direct holders, using their addresses registered in the trustee’s records.
Regardless of who acts as paying agent, all money that we pay to a paying agent that remains unclaimed at the end of two years after the amount is due to direct holders of debt securities will be repaid to us. After that two-year
period, the security holder may look only to us for payment and not to the trustee, any other paying agent or anyone else.
Governing Law
The debt securities and the indenture will be governed by and construed in accordance with the laws of the State of New York.
Concerning the Trustee
The Bank of New York Mellon acts as the trustee with respect to certain debt securities of certain of our subsidiaries.
If an event of default occurs, or an event occurs that would be an event of default if the requirements for either giving us notice or our default having to exist for a specified time period were disregarded, the trustee may be considered to have a conflicting interest with respect to the debt securities or the indenture for purposes of the Trust Indenture Act of 1939. In that case, the trustee may be required to resign as trustee under the applicable indenture and we would be required to appoint a successor trustee.
Exhibit 8.1
GROUP SUBSIDIARIES*
At December 31, 2023 |
|
Country |
|
Percentage of voting |
Wholly owned subsidiaries |
|
|
||
Alexion Pharmaceuticals, Inc. |
United States |
100 |
||
Alexion Pharma International Operations Limited Company |
Ireland |
100 |
||
AstraZeneca AB |
Sweden |
100 |
||
AstraZeneca Biotech AB |
Sweden |
100 |
||
AstraZeneca Dunkerque Production SCS |
France |
100 |
||
AstraZeneca Finance and Holdings Inc. |
United States |
100 |
||
AstraZeneca Intermediate Holdings Limited |
England |
100 |
||
AstraZeneca Treasury Limited |
England |
100 |
||
AstraZeneca UK Limited |
England |
100 |
||
MedImmune, LLC |
United States |
100 |
* Subsidiary companies which would be deemed to be a “significant subsidiary” in accordance with rule 1-02(w) of Regulation S-X as at December 31, 2023.
Exhibit 12.1
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT 2002
I, Pascal Soriot, certify that:
1. |
I have reviewed this annual report on Form 20-F of AstraZeneca PLC; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report; |
4. |
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have: |
a. |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. |
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. |
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and |
5. |
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions): |
a. |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and |
b. |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting. |
Date: 20 February 2024 |
|
|
|
|
|
By: |
/s/ Pascal Soriot |
|
|
|
|
Name: Pascal Soriot |
|
|
Title: Chief Executive Officer, AstraZeneca PLC |
|
|
Exhibit 12.2
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT 2002
I, Aradhana Sarin, certify that:
1. |
I have reviewed this annual report on Form 20-F of AstraZeneca PLC; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report; |
4. |
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have: |
a. |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. |
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. |
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and |
5. |
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions): |
a. |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and |
b. |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting. |
Date: 20 February 2024 |
|
|
|
|
|
By: |
/s/ Aradhana Sarin |
|
|
|
|
|
|
|
Name: Aradhana Sarin |
|
|
Title: Chief Financial Officer, AstraZeneca PLC |
|
|
Exhibit 13.1
CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 (SUBSECTIONS (a) and (b) OF SECTION 1350, CHAPTER 63 OF TITLE 18, UNITED STATES CODE)
The certification set forth below is being submitted in connection with the Annual Report on Form 20-F of AstraZeneca PLC for the year ended December 31, 2023 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code.
Pascal Soriot, the Chief Executive Officer and Aradhana Sarin, the Chief Financial Officer of AstraZeneca PLC, each certifies that, to the best of his knowledge:
1. |
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
2. |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of AstraZeneca PLC. |
Date: 20 February 2024 |
|
|
|
|
|
By: |
/s/ Pascal Soriot |
|
|
|
|
Name: Pascal Soriot |
|
|
Title: Chief Executive Officer, AstraZeneca PLC |
|
|
|
|
|
Date: 20 February 2024 |
|
|
|
|
|
By: |
/s/ Aradhana Sarin |
|
|
|
|
Name: Aradhana Sarin |
|
|
Title: Chief Financial Officer, AstraZeneca PLC |
|
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What science can do AstraZeneca Annual Report and Form 20-F Information 2023 |
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What science can do We are a global, science-led, patient-focused pharmaceutical business, committed to excellence in the research, development and commercialisation of prescription medicines. We aim to transform the lives of patients with improved outcomes and a better quality of life. We are using data, digital technologies and artificial intelligence to transform our business, accelerate our science and maximise our impact for people, society and the planet. See what we are doing in this area on page 6. Our Supplements Detailed information on our Development Pipeline, Patent Expiries of Key Marketed Products, Risk and Task Force on Climate-related Financial Disclosures (TCFD) Statement. See our website, www.astrazeneca.com/annualreport2023. Key For more information within this Annual Report. For more information, see www.astrazeneca.com. BV Denotes sustainability information independently assured by Bureau Veritas. CVRM diseases are complex and interconnected. It’s by understanding their interconnections and targeting the mechanisms that drive them that we’ll be able to detect, diagnose and treat people earlier and more effectively, stop disease progression and, ultimately, improve and save the lives of the millions of patients living with these diseases. Front cover image: Cardiovascular, Renal and Metabolic (CVRM) diseases. Use of terms: In this Annual Report, unless the context otherwise requires, ‘AstraZeneca’, ‘the Group’, ‘we’, ‘us’ and ‘our’ refer to AstraZeneca PLC and its consolidated entities. Welcome |
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zDenotes a scale break. Throughout this Annual Report, all bar chart scales start from zero. We use a scale break where charts of a different magnitude, but the same unit of measurement, are presented alongside each other. For more information in relation to the inclusion of Reported performance, Core financial measures and constant exchange rate (CER) growth rates as used in this Annual Report, see the Financial Review from page 52 and for more information on the reconciliation between Reported and Core performance, see the Reconciliation of Reported to Core results in the Financial Review on page 56. Corporate Governance Chair’s Introduction 76 Corporate Governance Overview 77 Board of Directors 78 Senior Executive Team (SET) 80 Corporate Governance Report 81 Nomination and Governance Committee Report 90 Science Committee Report 92 Sustainability Committee Report 93 Audit Committee Report 94 Directors’ Remuneration Report 102 Remuneration Policy 127 Financial Statements Preparation of the Financial Statements and Directors’ Responsibilities 140 Directors’ Annual Report on Internal Controls over Financial Reporting 140 Auditors’ Report 141 Consolidated Statements 148 Group Accounting Policies 152 Notes to the Group Financial Statements 160 Group Subsidiaries and Holdings 211 Company Statements 216 Company Accounting Policies 218 Notes to the Company Financial Statements 220 Group Financial Record 223 Additional Information Shareholder information 225 Directors’ Report 227 Sustainability supplementary information 230 Trade Marks 231 Glossary 232 Cautionary statement regarding forward-looking statements 236 Strategic Report Chair’s Statement 2 Chief Executive Officer’s Review 3 AstraZeneca at a Glance 5 What science can do: artificial intelligence 6 Healthcare in a Changing World 7 Our Purpose, Values and Business Model 10 Our Strategy and Key Performance Indicators 12 Therapy Area Review 16 > Oncology 16 > BioPharmaceuticals 20 – Cardiovascular, Renal & Metabolism 22 – Respiratory & Immunology 24 – Vaccines & Immune Therapies 26 > Rare Disease 28 Business Review 32 EU Taxonomy Disclosure 50 Task Force on Climate-related Financial Disclosures Summary Statement 51 Risk Overview 54 Financial Review 58 Contents Financial highlights Total Revenue1 Up 3% at actual rate of exchange to $45,811 million (up 6% at CER), comprising Product Sales of $43,789 million (up 2%; 4% at CER), Alliance Revenue of $1,428 million (up 89%; 89% at CER) and Collaboration Revenue of $594 million (down 1%; 1% at CER) Net cash flow from operating activities Up 5% at actual rate of exchange to $10,345 million 2023 2022 2021 $44,351m $37,417m $45,811m $45.8bn $10,345m $9,808m $5,963m 2023 2022 2021 $10.3bn Reported operating profit Up 118% at actual rate of exchange to $8,193 million (up 134% at CER) Core operating profit Up 9% at actual rate of exchange to $14,534 million (up 14% at CER) 2023 2022 2021 $8,193m $3,757m $1,056m $8.2bn $14,534m $13,350m $9,928m 2023 2022 2021 $14.5bn Reported EPS Up 81% at actual rate of exchange to $3.84 (up 96% at CER) Core EPS Up 9% at actual rate of exchange to $7.26 (up 15% at CER) 2023 2022 2021 $3.84 $2.12 $0.08 $3.84 2023 2022 2021 $7.26 $6.66 $5.29 $7.26 1 As detailed from page 152, Total Revenue consists of Product Sales, Alliance Revenue and Collaboration Revenue. Denotes a scale break. Throughout this Annual Report, all bar chart scales start from zero. We use a scale break where charts of a different magnitude, but the same unit of measurement, are presented alongside each other. For more information: In relation to the inclusion of Reported performance, Core financial measures and constant exchange rate (CER) growth rates as used in this Annual Report, see the Financial Review from page 58. For the reconciliation between Reported and Core performance, see the Reconciliation of Reported results to Core results in the Financial Review on page 62. Contents AstraZeneca Annual Report & Form 20-F Information 2023 1 Strategic Report Corporate Governance Financial Statements Additional Information |
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$2.90 Full-year dividend of $2.90 per share (2022: $2.90) “Our differentiated and growing portfolio of approved medicines, global reach and rich R&D pipeline give us confidence that we will continue to grow faster than the industry over the near and medium term” Performance and outlook As AstraZeneca celebrates its 25th anniversary, I was pleased we were able to report another year of strong financial development and scientific progress, with double-digit earnings growth, and investment in exciting areas of science that lay the foundations for long-term success. Reflecting this financial performance, the Board intends to declare a second interim dividend of $1.97 per share, making a total dividend declared for the full year of $2.90. Looking ahead, we expect another year of strong growth in 2024, driven by continued adoption of our medicines across geographies. Our differentiated and growing portfolio of approved medicines, global reach and rich R&D pipeline give us confidence that we will continue to grow faster than the industry over the near and medium term. A purpose-driven organisation In my time as a Director, I have experienced at first hand the commitment of AstraZeneca people to delivering our Purpose. And in my recent experience as Chair, whether at our Speke site in the UK or Gaithersburg in the US, our Gothenburg site in Sweden or our Tokyo office in Japan, I have been extremely impressed by the enthusiasm for everything they do. I would like to extend my personal thanks to everyone in AstraZeneca for all they have achieved in 2023, as well as to Pascal, the Senior Executive Team and my fellow Directors. Engaging stakeholders and shareholders The role AstraZeneca has to play in addressing public health challenges and promoting innovation and sustainable access to treatments resonates strongly with governments and other stakeholders I have met during the year. Through the Partnership for Health System Sustainability and Resilience (PHSSR), I engaged policymakers, academics and health leaders across countries to advance policies strengthening the capacity of health systems to absorb the impact of future crises, while effectively responding to today’s growing burden of diseases. AstraZeneca is incredibly proud to be a founding member of the PHSSR, a public-private partnership that is accelerating the transformation of health systems around the world. I also valued the opportunity to deepen AstraZeneca’s collaborations with patient advocacy groups, governments and the private sector to improve equitable health outcomes for all. Most recently I was proud to lead the AstraZeneca delegation at the World Economic Forum where we explored how to deepen our collaboration with key stakeholders to ensure healthcare is viewed as a strategic asset everywhere in the world. Finally, I have enjoyed meeting shareholders and understanding what you would like to see from AstraZeneca. I look forward to meeting more of you this year and to driving continued impact for patients. Michel Demaré Chair I was honoured to be appointed to succeed Leif Johansson as the Chair of AstraZeneca when he stood down at our Annual General Meeting in April. Leif brought together a strong Board, with an impressive and diverse mix of skills and experience, to oversee our ambitious pursuit of innovation and success. Leif and I share the view that a board has three core roles: maintaining good governance, oversight of strategy and development of people. As your new Chair, I look forward to focusing on these priorities and, building on my own experience in other organisations, working with the Board to unlock the full potential of what AstraZeneca has to offer. A clear strategy and ambitious goals AstraZeneca’s achievements and returns to shareholders are built on the successful delivery of our Growth Through Innovation strategy and our strategic priorities. We have ambitious plans for the future and are relentless in our focus to push the boundaries of science to deliver life-changing medicines. By living our Values and realising our strategic goals, we aim to transform patient outcomes, deliver industry-leading revenue growth, and ensure we remain a great place to work. Between 2023 and 2030, we aim to launch at least 15 new medicines and become carbon negative, thereby making an even bigger difference for people, society and the planet. AstraZeneca is focused on delivering its Purpose and has ambitious plans for the future. 2 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Chair’s Statement |
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$45.8bn Total Revenue (2022: $44.4bn) 56 Regulatory events – submissions or approvals in major markets “Our vision for health is not a short-term one. While maintaining our focus on discovering new small and large molecules, we are also increasing investment behind new modalities…” Innovating in science AstraZeneca has one of the leading development pipelines in the sector and its strength in 2023 was evidenced by first approvals for three new medicines – the first year in our eight-year goal of launching at least 15 new molecular entities (NMEs) between 2023 and 2030. Airsupra was approved for the first time in January 2023 for use as an as-needed treatment to reduce risk of asthma exacerbations. In November, Truqap in combination with Faslodex was approved for certain patients with advanced HR-positive breast cancer. And, right at the end of 2023, AstraZeneca and Ionis’ Wainua was approved for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. It is the only approved treatment that can be self-administered with an auto-injector. The good news continued in January 2024 with first approval of Voydeya, a first-in-class oral, Factor D inhibitor developed as an add-on to proven standard of care Ultomiris or Soliris to address the needs of a small subset of patients with paroxysmal nocturnal haemoglobinuria. The broad strength of our pipeline was exemplified by the fact that we achieved 56 regulatory events during the year, either submissions or approvals for our medicines in major markets. Additionally, we recorded 30 pipeline progression events, either NME Phase II starts or Phase III investment decisions. Of course, pushing boundaries sometimes means setbacks and, while we had some clinical trials during the year that did not meet their primary objectives, we are committed to improving health outcomes and learn from all our trials. Overall, 2023 was predominantly a year of scientific success and our pipeline progress indicates our ability to deliver longer-term sustainable growth. 2023 was a year of strong growth and execution of our long-term growth strategy as Total Revenue increased by 3% (6% at CER) to $45.8 billion. Excluding COVID-19 medicines, Total Revenue increased by 13% (15% at CER) to $45.5 billion. Continued growth in our therapy areas Our ability to grow the business builds on our broad-based, diverse sources of revenue across our therapy areas and regions. In our therapy areas, Total Revenue in 2023 for Oncology increased by 19% (21% at CER); Cardiovascular, Renal & Metabolism by 15% (18% at CER); and Respiratory & Immunology by 7% (10% at CER). Vaccines & Immune Therapies Total Revenue fell by 72% (71% at CER) as demand for COVID-19 medicines fell away, while Rare Disease rose by 10% (12% at CER). In our regions, Total Revenue in the US was up 6% in 2023, in Europe it grew by 10% (8% at CER) and by 2% (9% at CER) in Emerging Markets. Total Revenue fell by 14% (8% at CER) in Established Rest of World. Excluding COVID-19 medicines, Total Revenue grew in all regions. Our financial performance was matched by our operational performance, with 282 successful on-time launches during the year, overall supply performance of more than 99% and zero critical observations reported from 49 external inspections. This represents an outstanding performance that ensures a continuous supply of high-quality medicines to patients. 2023 was a year in which we continued to grow the business and deliver for patients. At the same time, we are investing for the future benefit of people, society and the planet. AstraZeneca Annual Report & Form 20-F Information 2023 3 Strategic Report Corporate Governance Financial Statements Additional Information Chief Executive Officer’s Review Chief Executive Officer’s Review |
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Importantly, the science in each of our therapy areas is making a real difference to the lives of people around the world. For example, in Oncology, Enhertu, the antibody drug conjugate we are developing with Daiichi Sankyo, is approved around the world for the treatment of HER2-mutated breast, lung and gastric cancers. In addition, in 2023, it received not one, but two more US Breakthrough Therapy Designations for multiple types of HER2-expressing tumours and HER2-positive colorectal cancer. Additionally, in January 2024, it was granted Priority Review in the US for patients with a range of metastatic HER2-positive solid tumours. These designations demonstrate the impact regulatory authorities believe Enhertu can have. Dato-DXd is also being developed with Daiichi Sankyo, and pivotal trial data announced during the year underlined our confidence in its potential to replace conventional chemotherapy for many patients with advanced lung and breast cancers. In BioPharmaceuticals, data from the Forxiga DELIVER trial was critical in informing a Class 1a recommendation in updated European Society of Cardiology Heart Failure guidelines. We have further strengthened our pipeline with CinCor’s candidate drug, baxdrostat for blood pressure lowering, with Quell to develop, manufacture and commercialise engineered T-regulatory cell therapies for autoimmune-driven diseases, and with Eccogene’s novel agent, AZD5004 for the treatment of obesity and broader cardiometabolic conditions. Our medicines are now helping patients with rare diseases in 70 markets – 18 more than 2021. Treatments include Ultomiris for multiple indications, including neuromyelitis optica spectrum disorder (NMOSD), a progressive autoimmune disease that impacts the central nervous system. With no relapses observed in the pivotal CHAMPION-NMOSD trial, Ultomiris marks a significant advance for these patients. Regulatory reviews are ongoing, including in the US, and it is already approved in the EU and Japan. People, society and the planet All AstraZeneca’s achievements are down to the skills and capabilities of its people, and I am delighted to see that we have a highly engaged workforce, with 86% believing that we are a great place to work. I am also pleased with the progress we are making in creating an inclusive multinational and multicultural environment where everyone belongs, and using this diversity as a competitive advantage. I am particularly proud that 50% of our senior roles are filled by women. Looking beyond AstraZeneca, 2023 was the year in which the world recognised that the climate crisis is a health crisis. This was no more apparent than at COP28 in Dubai where, for the first time, health was on the agenda and AstraZeneca was able to play a leading role in a dedicated Health Day that discussed the transition to low-carbon, climate-resilient health systems. AstraZeneca is working to decarbonise healthcare and is doing so in collaboration with peers, stakeholders and suppliers. Since 2015, there has been a 68% reduction in our Scope 1 and 2 greenhouse gas (GHG) emissions and, during 2023, we concluded agreements in the UK and in the US to use renewable natural gas, or biomethane, to supply clean heat to our sites. In addition, through our power purchase agreement in Sweden, we are expanding the country’s wind energy capacity. Also in 2023, we strengthened our investment in nature-based solutions by expanding our AZ Forest programme to include planting and maintaining 200 million trees across six continents by 2030. Overall, through our Ambition Zero Carbon strategy we are on track to halve our entire value chain Scope 1, 2 and 3 footprint by 2030 and, through AZ Forest, we aim to become carbon negative for all residual GHG emissions from 2030 onwards, removing more from the atmosphere than we emit. Of course, our greatest contribution to human health is through our medicines and securing a future where people have access to affordable, sustainable healthcare. Through our access to healthcare programmes, we have reached more than 66 million people, while our Partnership for Health System Sustainability and Resilience is fostering joint learning and acting as a catalyst to strengthen health systems in more than 30 countries. We are not resting there and are advancing a health equity strategy that will build on our existing access programmes to enable more equitable global health outcomes. Investing in future health Our vision for health is not a short-term one. While maintaining our focus on discovering new small and large molecules, we are also increasing investment behind new modalities that we believe have the potential to revolutionise outcomes for patients. We are exploring modalities such as cell, gene and RNA therapies, epigenetics and oligonucleotides to unlock entirely new treatment approaches and are excited by their curative potential. Our own efforts in these new modalities are supplemented by external expertise. In 2023, we announced the proposed acquisition of biotechnology company, Gracell, to further our cell therapy ambitions across oncology and autoimmune diseases, and an agreement with Cellectis, a clinical-stage biotechnology company, to accelerate cell therapy as well as genomic medicine. We also acquired a portfolio of preclinical rare disease gene therapies and our proposed acquisition of Icosavax, focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle platform, will build on our expertise in respiratory syncytial virus. We operate across the whole life-cycle of a medicine and, in November, we launched Evinova, a health-tech business designing and leveraging digital tools to accelerate innovation across the life sciences sector, the delivery of clinical trials as well as better health outcomes. As shown throughout this Report, our efforts to push the boundaries of science are helped by artificial intelligence and new digital technologies that allow us to discover and deliver new treatments faster than ever before and drive a step-change in the diagnosis, monitoring and treatment of patients. Colleagues In closing, I want to thank all the AstraZeneca team for the part they have played in an exceptional year and for what we have been able to achieve for people, society and the planet. Thanks also go to my colleagues on the Senior Executive Team where, during the year, we welcomed Sharon Barr, who joined as Executive Vice President, BioPharmaceuticals R&D to replace Mene Pangalos, who retires in 2024. Sharon brings outstanding experience from Alexion and a track record of driving productivity, innovation and delivery of medicines. I want to thank Mene for his remarkable contribution to AstraZeneca and all he has done to transform how we approach R&D. In particular, I would like to pay tribute to the role he played in AstraZeneca’s response to the COVID-19 pandemic. The quality of the medicines he has brought to patients, and the pipeline and capabilities he has built, will be his legacy for many years to come. In the year when we said farewell to Leif Johansson as Chair, I would like to close by extending my thanks to his successor, Michel Demaré, who continues to ensure we pursue our Purpose of pushing the boundaries of science to deliver life-changing medicines. Pascal Soriot Chief Executive Officer 4 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Our strategic priorities Our priorities reflect how we are working to deliver our Growth Through Innovation strategy and achieve our Purpose of pushing the boundaries of science to deliver life-changing medicines. Science and innovation-led We use our distinctive scientific capabilities to deliver a pipeline of life-changing medicines. 178 projects in our development pipeline1 17 new molecular entities (NMEs) in our late-stage pipeline Leading in our Therapy Areas We are focused on areas where we can make the most meaningful difference to patients. Therapy Areas Oncology BioPharmaceuticals Rare Disease Total Revenue2 $45.8bn $45.8bn $44.4bn $37.4bn 2023 2022 2021 Diversified portfolio and global reach With a focus on patients, we have a global reach and a diversified portfolio of medicines across primary care, specialty care and rare diseases. Total Revenue by Therapy Area Oncology 40% BioPharmaceuticals 40% Rare Disease 17% Other Medicines 3% Total Revenue by reporting region US 42% Emerging Markets 26% Europe 21% Established Rest of World 11% Positively impacting people, society and the planet BV We are committed to operating in a way that recognises the interconnection between business growth, the needs of society and the limitations of our planet. 66.4m people reached by our access to healthcare programmes 67.6% reduction in Scope 1 and 2 GHG emissions since 2015 Rating of AA in the MSCI ESG Ratings assessment Top 20% of 2,500 of the world’s largest companies and Europe Index constituent 123 NME or major life-cycle management (LCM) projects in Phase II and Phase III 1 Includes NME and major LCM projects up to launch in all applicable major markets. AstraZeneca Annual Report & Form 20-F Information 2023 5 Strategic Report Corporate Governance Financial Statements Additional Information AstraZeneca at a Glance 1. Science and Innovation 2. Growth and Therapy Area Leadership 3. People and Sustainability We are a global, science-led, patient-focused pharmaceutical business. We are dedicated to transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. AstraZeneca at a Glance 2 Total Revenue includes revenues from Other Medicines. |
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Science can… In research and development (R&D), AI transforms our understanding of disease biology; drives earlier diagnosis; and helps us create the next generation of medicines and pioneer new approaches in the clinic and beyond. See page 34. In Operations, AI enhances manufacturing and supply, enabling us to respond more pro-actively, drive automation and robotics, and raise quality standards still further. See page 40. In our therapy areas and markets, AI helps create new ways of doing business and build new and more integrated healthcare systems, helping healthcare practitioners treat more patients earlier and empower patients. See from page 16 and page 41. Across the business, AI enables us to work more effectively, as well as work seamlessly with industry and academic partners. We aim to do so in a way that is responsible, ethical and transparent for the benefit of people, society and the planet. See page 41. Artificial intelligence (AI) and our ability to process and understand vast amounts of data is accelerating innovative science, allowing us to discover and deliver new medicines faster than ever before. It helps healthcare professionals diagnose, monitor and treat patients more personally and precisely, helps patients play an active part in their own treatment, and enables care to move from disease management to stopping the progress of disease, long-term remission, and even cure. For more information on our approach to AI, please see IT and IS resources on page 41. 6 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report What science can do: artificial intelligence |
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2023 2022 2021 1,216 1,121 1,332 World ($bn) $1,332bn (9.6%) 2023 2022 2021 102 97 108 Established RoW ($bn) $108bn (+5.7%) 2023 2022 2021 608 556 678 US ($bn) $678bn (+11.5%) 2023 2022 2021 277 257 299 Emerging Markets ($bn) $299bn (+8.0%) 2023 2022 2021 230 211 248 Europe ($bn) $248bn (+7.8%) The external environment presents us with both challenges and opportunities that require us to adapt, innovate and build trust. Global pharmaceutical sales In 2023, average revenue grew 10.0% in Established Markets and 8.0% in Emerging Markets. The US, Japan, China, Germany and France are the world’s top five pharmaceutical markets by 2022 sales. In 2023, the US had 50.9% (2022: 50.0%) of global sales. Data based on world market sales using AstraZeneca Market definitions as set out on page 232. Changes in data subscriptions, exchange rates and subscription coverage, as well as restated IQVIA data, have led to the restatement of total market values for prior years. Source: IQVIA, IQVIA Midas Quantum Q2 2023 (including US data). Reported values and growth are based on CER. Value figures are rounded to the nearest billion and growth percentages are rounded to the nearest tenth. We expect both developed and developing markets to fuel pharmaceutical growth. Market growth in China is expected to remain below historical levels at a compound annual growth rate of 3.9%, due to the continued slowdown of the major hospital sector. 1 Non-EU countries; including the UK. 2 Commonwealth of Independent States; includes Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and excludes Ukraine. $1,332bn (+9.6%) Estimated pharmaceutical sales 2027. Data is based on ex-manufacturer prices at CER. Source: IQVIA. Estimated pharmaceutical market growth. Data is based on the compound annual growth rate from 2022 to 2027. Source: IQVIA Market Prognosis Global 2023–2027. Other Europe1 $93bn 10.6% Japan $73bn 0.3% China $190bn 3.9% Oceania $21bn 3.9% Southeast and East Asia $270bn 4.8% Middle East $32bn 6.6% Africa $32bn 5.9% Indian subcontinent $51bn 9.5% CIS2 $37bn 6.3% EU $335bn 6.2% North America $992bn 7.8% Latin America $197bn 22.0% Estimated pharmaceutical sales and market growth to 2027 A growing pharmaceutical sector The pharmaceutical sector continues to grow against a backdrop of increasing demand for healthcare. Global pharmaceutical sales grew by 9.6% in 2023. Global healthcare spending is projected to increase at an annual rate of 7.8% from 2022 to 2027. Healthcare in a Changing World Healthcare in a Changing World AstraZeneca Annual Report & Form 20-F Information 2023 7 Strategic Report Corporate Governance Financial Statements Additional Information |
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Along with others, the pharmaceutical sector faces economic challenges, geopolitical uncertainty and the challenge of climate change. Rapidly-evolving technologies offer many benefits, while demographic change is driving an increased demand for healthcare. Successful organisations are transparent and build trust with their stakeholders. Impact of global trends Increasing geopolitical tensions may weaken the economic landscape with broader consequences for companies. Economic recovery remains slow and uneven after the COVID-19 pandemic and invasion of Ukraine. Every country in the world is experiencing growth in the number and proportion of older people. The war in Ukraine and the COVID-19 pandemic have accelerated a historic shift in the global order. Also, urgent, short-term risks are creating economic and geopolitical changes that may hasten other global threats. Current crises that divert attention and resources from medium- to longer-term risks may increase pressures on natural and human ecosystems. Some of these risks are close to a point of no return, but opportunities exist to shape a more secure future. Geopolitical tensions, such as conflict in the Middle East, increase pressure on companies’ supply and distribution networks and may also have ripple effects over the medium term, contributing to a potential ‘polycrisis’ of interrelated environmental, geopolitical and socioeconomic risks relating to natural resources supply and demand. Geopolitical tensions and economic pressures have already limited, and in some cases reversed, progress on climate change mitigation, at least over the short term. (Source: World Economic Forum (WEF): The Global Risk Report 2023 18th edition) These growth projections remain below the historical (2000-2019) average of 3.8%. For advanced economies, the expected slowdown is from 2.6% in 2022 to 1.5% in 2023 and 1.4% in 2024, with stronger than expected US momentum but weaker than expected growth in the euro area. Emerging market and developing economies are projected to have modestly declining growth, from 4.1% in 2022 to 4.0% in both 2023 and 2024. Forecasts for global growth over the medium term, at 3.1%, are at their lowest in decades, and prospects for countries to catch up to higher living standards are weak. The likelihood of a hard economic landing has receded, but the balance of risks to global growth remains tilted to the downside. Global inflation was forecast to decline steadily, from 8.7% in 2022 to 6.9% in 2023 and 5.8% in 2024 but is not expected to return to target until 2025 in most countries. (Source: IMF World Economic Outlook, October 2023) By 2050, the world’s population of people aged 60 and older will double, to 2.1 billion. The number of people aged above 80 is expected to triple between 2020 and 2050, to 426 million. This places strains on healthcare systems and reduces the pool of working age people. Low- and middle-income countries (LMICs) are now seeing the greatest population changes. By 2050, two thirds of the world’s over 60s will live in LMICs, which are also disproportionately affected by non-communicable diseases (NCDs). NCDs kill 41 million people each year, more than three quarters of these in LMICs. NCDs represented seven of the 10 leading causes of death in 2019 or 74% of deaths globally. Cardiovascular (CV) diseases account for 17.9 million deaths annually, followed by cancers (9.3 million), chronic respiratory diseases (4.1 million) and diabetes (2.0 million). (Source: WHO) Top three Top CEOs identify digital disruption, the economy, and geopolitical uncertainties as the most important trends. (Source: McKinsey & Company: CEO Excellence Survey 2023) 2.9% Global GDP growth was forecast to slow from 3.5% in 2022 to 3.0% in 2023 and 2.9% in 2024. (Source: International Monetary Fund (IMF) World Economic Outlook, October 2023) 1 in 6 By 2030, 1 in 6 people in the world will be aged 60 or over. (Source: World Health Organization (WHO)) Economic Activity falls short of pre-pandemic path Societal Increasing pace of population ageing Political Growing geopolitical complexity 8 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Healthcare in a Changing World continued |
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The use of AI has significant potential but also risks that must be managed. Climate change and ecosystem degradation impact human health and undermine the capacity of health systems. AI has the potential to bring significant benefits to the healthcare sector. For example, data science and AI can increase productivity in research, development and manufacturing, helping new medicines to reach patients more quickly. For medical professionals, AI can improve decision making, reduce errors and costs, personalise care plans and enhance patient monitoring. AI may also enhance the quality and accessibility of healthcare services, especially in remote and underserved areas. However, a survey of chief risk officers by the WEF identified concerns about the potential harms caused by AI technologies – deliberately or inadvertently. More than 90% of respondents wished to see an accelerated pace of regulation around the development of these technologies to ensure the benefits can be realised safely. (Source: WEF: Chief Risk Officers Outlook July 2023) Climate change is a threat to human wellbeing and planetary health. There is a rapidly closing window of opportunity to secure a liveable and sustainable future for all. Without urgent, effective and equitable mitigation and adaptation actions, climate change increasingly threatens ecosystems, biodiversity, and the livelihoods, health and wellbeing of current and future generations. (Source: Intergovernmental Panel on Climate Change (IPCC) Summary for Policymakers of Synthesis Report on Climate Change 2023) Demand for healthcare is increasing and science is driving improvements in healthcare, but risks remain for the sector. While demographic and other changes are driving an increased demand for healthcare, continued advances in science and digital technologies are driving healthcare innovation and improvements. But risks remain. In addition to the downward pricing pressure, the sector faces regulatory challenges, loss of exclusivity and genericisation, and increasing expectations from various stakeholders. To succeed, pharmaceutical companies must be able to take advantage of AI and emerging technologies. They also need to respond to the demands and expectations, and earn the trust of patients and caregivers, healthcare professionals and health authorities, payers, policymakers and others. They need to protect themselves against harmful misinformation and disinformation, which will require collaboration between businesses, policymakers and other stakeholders to tackle at scale. 27x Investment in AI-enabled drug discovery is estimated to have grown 27-fold in the past nine years, exceeding $60 billion in 2023. (Source: Deep Pharma Intelligence) 100,000 2023 brought the highest global temperatures in more than 100,000 years. (Source: 2023 report of the Lancet Countdown on health and climate change) 34% In a 21-country survey, 34% rated pharmaceutical companies trustworthy (31% in 2022), higher than any other sector. But 22% still distrust the industry. (Source: Ipsos Global Trustworthiness Monitor: Stability in an unstable world) Technological Emerging regulatory regimes for AI Environmental Climate change accelerating Outlook Opportunities and challenges for the sector These risks are explored further in the Risk Overview from page 54 and Pricing and value of our medicines from page 39. AstraZeneca’s response to the trends we face is explored further in Our Strategy and Key Performance Indicators from page 12. Healthcare in a Changing World AstraZeneca Annual Report & Form 20-F Information 2023 9 Strategic Report Corporate Governance Financial Statements Additional Information |
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What our business model requires to be successful How we add value Improved health Continuous scientific innovation is vital to achieving sustainable healthcare, which creates value by: > Improving health outcomes and transforming the lives of patients who use our medicines. > Enabling healthcare systems to reduce costs and increase efficiency. > Improving access to healthcare and healthcare infrastructure. > Helping develop the communities in which we operate through local employment and partnering. Financial value Revenue from our Product Sales and collaboration activities generates cash flow, which helps us: > Fund our investment in science and the business to drive long-term value. > Follow our progressive dividend policy. > Meet our debt service obligations. >116m1 Our main therapy area medicines impact more than 116 million patient lives annually. Ability to acquire, retain and develop a talented and diverse workforce. 50.1% of our senior middle management roles and above are filled by women Global commercial presence and skills that ensure our medicines are available to patients when needed. >125 countries where we sell our products A leadership position in science that enables us to deliver life-changing medicines. $10.9bn invested in our science in 2023 Patent protection for our intellectual property for a reasonable period of time to prevent our new medicines being copied. >90 countries where we obtained patent protection Understanding the issues that are most important to our many and varied stakeholders. >199,000 healthcare practitioner enquiries responded to A supply of high-quality medicines, whether from our own operations or from suppliers. $22.2bn spent with suppliers Effective collaborations that supplement and strengthen our pipeline and our efforts to achieve scientific leadership. >1,000 collaborations worldwide Financial strength, including access to financing and ability to bear the financial risk of investing in the life‑cycle of a medicine. $10.3bn net cash flow from operating activities Our business model Inspired by our Values and what science can do, we are focused on accelerating the delivery of life-changing medicines that create enduring value for patients, society, the planet and our shareholders. We are a global pharmaceutical business with a science-led and patient-focused value proposition committed to excellence in the research, development, manufacturing and commercialisation of prescription medicines. We are also committed to operating sustainably, in a way that recognises the interconnection between business growth, the needs of society and the limitations of our planet. We invest resources to create financial and non‑financial value that benefit patients, society, the planet and our business. Our Values determine how we work together and the behaviours that drive our success. They guide our decision making and define our beliefs. > We follow the science. > We put patients first. > We play to win. > We do the right thing. > We are entrepreneurial. Our Purpose We push the boundaries of science to deliver life-changing medicines. Our Values Business Review, see from page 32. 10 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Our Purpose, Values and Business Model |
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This is a high-level overview of a medicine’s life-cycle and is illustrative only. It is neither intended to, nor does it, represent the life-cycle of any particular medicine or of every medicine discovered and/or developed by AstraZeneca, or the probability of success or approval of any AstraZeneca medicine. 1 The patient numbers reached for AstraZeneca medicines is an estimation of the average number of patients on our medicines in a given year. The calculation is based upon the volume that we manufacture globally, converted using the number of days of therapy (DoT) and the average patient compliance with their treatment. If a patient is treated by more than one AstraZeneca product they are double-counted. Investment in discovery, development, manufactur ni g and commerc ai l si at oi n of pa et t n p- or cet mdet seni ci de e R ev nue gene ar t oi n Reinvestment ofreturns Inputs > Applying our resources to address unmet medical need Outputs > Improved health > Returns to shareholders Our Purpose Research and development phases 5-15 years aL nu hc phase 5 1- 5 years Post-exclusivity 20+ years 1 2 3 4 5 6 7 8 9 Life-cycle of a medicine We create financial value throughout the life-cycle of a medicine. Investment We invest in the discovery, development, manufacturing and commercialisation of our pipeline of innovative prescription medicines. Revenue generation We generate revenue from Product Sales of our existing medicines and new medicine launches, as well as from our collaboration activities. Our focus is on creating medicines that facilitate profitable future revenue generation, while bringing benefits to patients. Reinvestment We reinvest in developing the next generation of innovative medicines and in our business to provide the platform for future sources of revenue in the face of losses of key patents. We also assess opportunities to invest in value-enhancing additions to our portfolio. 1. Undertake scientific research to identify potential new medicines. 2. Preclinical studies in laboratory and animals to understand if the potential medicine is safe to introduce into humans. 3. Phase I trials with small groups of healthy human volunteers (small molecules) or patients (biologics) to understand how the potential medicine is absorbed into the body, distributed and excreted. Launch phase – duration: 5-15 years 7. Launch new medicine while continuously monitoring, recording and analysing reported side effects. 8. Post-launch R&D to further understand the benefit/risk profile of the medicine and life-cycle management activities to understand its full potential. Post-exclusivity – duration: 20+ years 9. Patent expiry and generic medicine entry. 4. Phase II trials on small- to medium-sized groups of patients to test effectiveness and tolerability of the medicine and determine optimal dose. 5. Phase III trials in a larger group of patients to gather information about effectiveness and safety of the medicine and evaluate the overall benefit/risk profile. 6. Seek regulatory approvals for manufacturing, marketing and selling the medicine. Research and development phases – duration: 5-15 years AstraZeneca Annual Report & Form 20-F Information 2023 11 Strategic Report Corporate Governance Financial Statements Additional Information Our Purpose, Values and Business Model |
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KPI key Used for remuneration of Executive Directors 2030 Bold Ambition Our bold aspiration is to be pioneers in science, lead in our disease areas, and transform patient outcomes. Between 2023 and 2030, we aim to deliver at least 15 new medicines, industry-leading growth and be carbon negative. Our 2030 Bold Ambition workstreams focus on accelerating our strategic priorities, exploring new ones and building for the future. Our Key Performance Indicators and remuneration We measure our productivity and success against our Key Performance Indicators (KPIs), which are aligned to our strategic priorities. Several KPIs in this section are used to measure the remuneration of Executive Directors, allowing us to disclose aggregated targets without disclosing sensitive commercial information at the individual KPI level. Any variances between the KPI and values used in determining remuneration are explained in the Directors’ Remuneration Report from page 102. Since 2021, we have included the delivery of our Ambition Zero Carbon commitments in our executive incentive arrangements. Achieve Group Financial Targets Key Performance Indicators Cash generation is a key driver of long-term shareholder returns and facilitates reinvestment in our pipeline, which is critical for delivering new medicines and future value. Earnings per share (EPS) is an important profitability metric and a key driver of shareholder value. Actual growth 2023 +81% 2022 n/m 2021 -97% CER growth 2023 +96% 2022 n/m 2021 -84% Actual growth 2023 +9% 2022 +26% 2021 +32% CER growth 2023 +15% 2022 +33% 2021 +37% Actual growth 2023 +5% 2022 +64% 2021 +24% 2023 2022 2021 $3.84 $2.12 $0.08 $3.84 Reported EPS 2023 2022 2021 $7.26 $6.66 $5.29 $7.26 Core EPS 2023 2022 2021 $10,345m $9,808m $5,963m $10,345m Net cash flow from operating activities Our ambition is to launch at least 15 new medicines by 2030. Three were approved in 2023. We have three strategic priorities, whose effective delivery will help us achieve our financial targets. Our capital allocation priorities include investing in the business and pipeline, including potentially value-enhancing business development opportunities; maintaining a strong, investment-grade credit rating; and supporting a progressive dividend policy, balancing opportunities for growth and maintaining a strong balance sheet. Our Growth Through Innovation strategy is built on the fact that AstraZeneca: > is science and innovation led > is focused on our chosen therapy areas: Oncology; BioPharmaceuticals (comprising Cardiovascular, Renal & Metabolism (CVRM), Respiratory & Immunology (R&I) and Vaccines & Immune Therapies (V&I)); and Rare Disease > is focused on patients and a diversified portfolio that spans across primary care, specialty care and rare disease > has global strength with a balanced presence across regions > has a commitment to people, society and the planet. 2. Growth and Therapy Area Leadership 1. Science and Innovation 3. People and Sustainability Achieve Group Financial Targets For more information on our Core measures, see the Financial Review from page 58. For details of how Achieve Group Financial Targets are considered when calculating the annual bonus, see page 111. 12 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Our Strategy and Key Performance Indicators |
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1 30 against our Group scorecard for determining annual bonus. 2 25 against our Group scorecard for determining annual bonus. 3 26 against our Group scorecard for determining annual bonus. 1 46 against our Group scorecard for determining annual bonus. 2 50 against our Group scorecard for determining annual bonus. 3 37 against our Group scorecard for determining annual bonus. Science and Innovation Key Performance Indicators Our science measures incentivise the development of NMEs and the maximisation of the potential of existing medicines. Pipeline progression events (Phase II NME starts/progressions and Phase III investment decisions) measure innovation and sustainability. Regulatory events (regulatory submissions and approvals) demonstrate the advancement of this innovation to patients and the value to the Group. “Our bold aspiration is to be pioneers in science, lead in our disease areas, and transform patient outcomes.” Our focus areas > Creating the next generation of therapeutics using an array of drug modalities, for example, advanced biologics, genomic medicines and nucleotide-based and cell therapies. > Leading in convergence of science, data and technology. > Advancing our pipeline. How our strategy responds to global trends To ensure we are able to respond to the increasing burden of disease and maximise advances in science and digital technologies, we are: > Advancing our understanding of disease biology to help uncover novel drivers of disease, through multi-omics, functional genomics and innovations in AI and machine learning. > Progressing an early pipeline consisting of numerous new drug modalities, including ADCs, antibodies (e.g. bispecific, inhaled fragment and cell depleting monoclonal), cell therapies, genomic medicines, PROteolysis TArgeting Chimeras (PROTACs), oligonucleotides and T-cell engagers. > Creating cutting-edge models to generate data that are more relevant to patients, to better predict the success of our molecules in the clinic. > Pioneering clinical innovation to design and deliver patient-centric clinical trials that improve the patient and site team experience while optimising the use of data, digital and AI to improve patient outcomes. > Embedding AI across R&D, from target identification to clinical development, to deliver medicine to patients faster than ever before. How we progressed in 2023 > Three NME approvals in 2023: Airsupra, Truqap and Wainua. Voydeya was approved in January 2024. > Achieved 56 regulatory events: 31 NME and major LCM submissions and 25 approvals in major markets (US, EU, China and Japan). > Secured 30 pipeline progression events: six NME Phase II starts/progressions and 24 NME and major LCM Phase III investment decisions. > Our pipeline includes 178 projects, of which 160 are in the clinical phase of development. > At the end of the year, we had 17 NME projects in pivotal trials or under regulatory review covering 31 indications. > 18 projects were discontinued. > Launched Evinova, a health-tech business intended to accelerate innovation across the life sciences sector, the delivery of clinical trials and better health outcomes. 2030 Bold Ambition workstreams Accelerating thinking around our initiatives, exploring new ones and identifying the best ways to grow the business: > China innovation – collaborating to support development of innovation in China. > Rare cancer – combining the capabilities of our Oncology and Rare Disease teams. > Genomic medicine – collaborating across our teams to unlock the promise of genomic medicine and improve the lives of people living with a rare genetic disease. > Cell therapy – scaling our efforts to use cell therapy to halt and reverse disease. > Immune diseases – expanding our capabilities and platforms to focus on treating diseases with high unmet medical need. 2023 2022 2021 301 292 323 301 Pipeline progression events 2023 2022 2021 561 722 493 561 Regulatory events For more information, see: Therapy Area Review from page 16 and Business Review from page 32. 2023 Group scorecard assessment on page 111 for performance against the Group scorecard. AstraZeneca Annual Report & Form 20-F Information 2023 13 Strategic Report Corporate Governance Financial Statements Additional Information Our Strategy and Key Performance Indicators |
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2023 2022 2021 $45,811m $44,351m $37,417m $45,811m Total Revenue Our focus areas > Delivering industry-leading growth across our therapy areas and regions. > Embracing digital technologies and data to transform the patient journey, putting them at the heart of everything we do. > Continuing with the next phase of our Operations 2025 programme, including implementing next-generation manufacturing technologies and smart factory capabilities: Operations 2030. How our strategy responds to global trends To ensure we can respond to the increasing demand for healthcare, downward pressure on prices and increasing control that people have over their own healthcare, we are: > Fostering a patient-focused approach and embedding patient insights across our organisation, building integrated therapy area ecosystem models. > Engaging with policymakers to support improvements in sustainable access, coverage, care delivery and patient care outcomes. > Leveraging technology across prevention and awareness, diagnosis, treatment, post-treatment and wellness to deliver better patient outcomes. > Partnering with industry, governments and others to adopt value-based pricing solutions and bring new medicines to market more quickly. > Pursuing a strong patent strategy that builds robust patent estates to protect our pipeline and products while defending and enforcing patent rights. > Harnessing the power of digital throughout our end-to-end supply chain through digital drug development to accelerate development lead times. How we progressed in 2023 > Total Revenue, comprising Product Sales, Alliance Revenue and Collaboration Revenue, increased by 3% (6% at CER) to $45,811 million. Total Revenue, excluding COVID-19 medicines¹ , increased 13% (15% at CER) to $45,488 million. > Alliance Revenue increased by 89% (89% at CER) to $1,428 million. > Collaboration Revenue decreased by 1% (1% at CER) to $594 million. > Grew Total Revenue across our Therapy Areas: Oncology 19% (21% at CER) to $18,447 million; CVRM 15% (18% at CER) to $10,628 million; and R&I grew 7% (10% at CER) to $6,404 million. Our V&I unit declined by 72% (71% at CER) to $1,357 million and Rare Disease grew by 10% (12% at CER) to $7,764 million. > Total Revenue in the US grew by 6% to $19,077 million. In Emerging Markets it grew by 2% (9% at CER) to $12,025 million and in Europe grew by 10% (8% at CER) to $9,611 million. 2030 Bold Ambition workstreams Accelerating thinking around our initiatives, exploring new ones and identifying the best ways to grow the business: > Transforming care – supporting health systems to identify, diagnose and treat more people living with chronic and rare diseases, and cancer. > US growth – transforming patient outcomes by accelerating innovation in customer engagement, expanding participation in clinical trials and ensuring equitable access to our medicines. > Operations 2030 – bringing our pioneering scientific innovation to patients through agile, connected and sustainable supply chains. “We have global strength with a balanced presence across regions and a diversified portfolio.” Growth and Therapy Area Leadership 1 The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152 – the COVID-19 antibody currently in development. Actual growth 2023 +3% 2022 +19% 2021 +41% CER growth 2023 +6% 2022 +25% 2021 +38% Key Performance Indicators Our Total Revenue measure reflects the importance of incentivising sustainable growth in both the short and longer term. For details of how Total Revenue is considered when calculating the annual bonus, see from page 111. 14 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Our Strategy and Key Performance Indicators continued |
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2023 2022 2021 86% 86% 85% 86% Employee belief that AstraZeneca is a great place to work1 2023 25/27 2022 7/9 2021 10/12 Green Amber Red 25/27 Sustainability scorecard performance2 Our focus areas > Maintaining employee engagement by continuing to make AstraZeneca a great place to work. > Focusing on delivering our inclusion and diversity strategy, and learning and development programmes. > Ensuring we operate in the smartest way and increase the speed of delivery of medicines to patients through our business transformation programmes. > Playing our part in protecting the planet by realising our ambition to become carbon negative for all residual emissions from 2030. > Leading the way in our efforts to improve access to healthcare and build health system resilience. > Harnessing the power of science and innovation in ways that positively impact patients, healthcare systems and the environment. > Advancing our sustainability priorities, particularly health equity and health system resilience, as well as addressing the effects of the twin climate and nature crises and the impact on global health and healthcare. How our strategy responds to global trends To ensure we are able to deliver our strategy, build trust in AstraZeneca and contribute to the health of society and the planet, we are: > Creating an inclusive and equitable environment where people belong, using our diversity as a competitive advantage. > Fostering a culture of lifelong learning, strengthening and evolving our capabilities, and instilling confidence to challenge convention and explore possibilities. > Simplifying the way we work, driving productivity, and optimising digital and technology to deliver a better experience for our people and better outcomes for patients. > Working towards a future where all people have access to affordable, sustainable and innovative healthcare. > Playing our part in protecting the planet by reducing GHG emissions from our global operations and fleet by 98% by 2026 and halving our entire value chain footprint by 2030. > Empowering employees through our Code of Ethics to make decisions in the best interests of the Group and society. How we progressed in 2023 > We continued to invest in our people to ensure we recruit, retain and develop a talented workforce. > In 2023, we delivered a strong performance across the key priorities of our People and Sustainability strategy pillar. > We continued to score highly in our Pulse surveys for questions relating to our Purpose, direction, patient centricity and employee commitment to our success. > We demonstrated our continued commitment to investing in global collaborations, Group initiatives, and local partnerships to strengthen health systems. > We maintained a leading role in industry efforts to address the effects of climate change on our planet and accelerate the delivery of net-zero healthcare, while improving health outcomes and reducing our environmental impact. > Our Ambition Zero Carbon strategy delivered further reductions in our GHG emissions across our value chain – Scopes 1, 2 and 3 – and we are on track with our environmental commitments. 2030 Bold Ambition workstreams Accelerating thinking around our initiatives, exploring new ones and identifying the best ways to grow the business: > Employee experience – being a great place to work, where people feel a sense of community, collaboration and purpose. > Sustainability – going ‘beyond climate’ to drive a nature restoration approach to all we do, while ensuring that the most vulnerable people in society have access to our medicines. > Technology – identifying, prioritising and adopting leading-edge technologies, while upskilling and empowering our people to drive productivity. > Axial project – rethinking how we manage our supply chains, manufacturing, customer experience, financial reporting, financial planning and people management. > Business transformation – smarter, more innovative ways of working and exploring how we can become more productive. People and Sustainability Key Performance Indicators BV Our People and Sustainability strategy is built around two priorities: Contribution to the enterprise and Contribution to society. Our Contribution to the enterprise KPI is based on our Pulse survey measure of those employees who believe that AstraZeneca is a great place to work. Our Contribution to society KPI is based on our sustainability scorecard. Ratings for this KPI reflect our success in achieving our sustainability goals. Our 2023 scorecard is based on nine focus areas that guide our sustainability strategy and show where we can have the most positive impact. These are detailed in our Sustainability Report: www.astrazeneca.com/sustainability. 2 In 2023, we assessed our performance against 27 publicly available targets across our three integrated sustainability priority pillars. At least 90% of targets need to be ‘on plan’ to achieve a scorecard rating of green; at least 70% for amber; and red signifies any percentage below this. 1 Source: November Pulse survey for each year. “We’re unlocking the power of what science can do for people, society and the planet.” For more information, see People and Sustainability from page 46. For more information on our KPIs, including definitions, methodology and restatements, see our Sustainability Data Summary at www.astrazeneca.com/ sustainability. AstraZeneca Annual Report & Form 20-F Information 2023 15 Strategic Report Corporate Governance Financial Statements Additional Information Our Strategy and Key Performance Indicators |
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Unmet medical need and world market 2nd Cancer is the second leading cause of death worldwide. 16.3m By 2040, cancer is expected to account for 16.3 million deaths annually across the globe. Small molecule targeted agents $56.2bn Immune checkpoint inhibitors $45.1bn Monoclonal antibodies (mAbs) $40.0bn Chemotherapy $23.3bn Hormonal therapies $17.7bn PARP inhibitors $3.5bn Other oncology therapies $1.0bn $187.0bn Annual worldwide market value Therapy area world market (MAT Q3-23) We are leading a revolution in oncology to redefine cancer care. Our ambition is to follow the science to discover, develop and deliver life-changing treatments that transform outcomes and increase the potential for cures. Oncology 2023 overview > Performance driven by rapid and broad market penetration of our oncology medicines with 10 major market approvals across six medicines, including Imfinzi, Enhertu, Lynparza, Calquence, Imjudo and a new medicine approved for the first time, Truqap. > Nine positive Phase III trial readouts across tumour types including the first positive pivotal results for datopotamab deruxtecan (Dato-DXd) in lung and breast cancers. Total Revenue $18,447m up 19% (21% at CER) 2022: $15,539m 2021: $13,555m1 Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Oncology Therapy Area submarket totals ($186.8bn) do not sum up exactly to the Therapy Area total ($187.0bn) due to rounding. 1 Total Revenue from Koselugo is included within Rare Disease for 2022 and 2023 reporting, previously reported within Oncology. The 2021 comparatives and growth rates shown for each therapy area have been calculated as though these changes had been implemented in 2021. T-cell engager molecule directing a T-cell to a cancer cell 16 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Therapy Area Review |
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Full details are given in the Development Pipeline and Patent Expiries of Key Marketed Products Supplements on our website, www.astrazeneca.com/ annualreport2023. Our strategy in Oncology We strive to push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer through: 1. Scientific platforms to attack cancer from multiple angles, including targeting cancer cells directly and activating the immune system. We use monotherapy and combination approaches to drive deeper, more durable, responses: a. Tumour drivers and resistance – targeting genetic mutations and resistance mechanisms that enable cancer cells to survive and proliferate. b. DNA damage response – targeting the DNA repair process to block cancer cells reproducing. c. Antibody Drug Conjugates (ADCs) – highly potent cancer-killing agents delivered directly to cancer cells via a linker attached to a targeted antibody. d. Epigenetics – targeting changes to genome expression caused by cancer. e. Immuno-oncology – activating the body’s own immune system to help fight cancer. f. Cell therapies – harnessing living cells to target cancer. g. Immune engagers – redirecting the immune system’s T-cells to the tumour and amplifying that patient’s own anti-cancer immune response. 2. Treating cancer earlier where the greatest opportunity for cure exists and building expertise and leadership in key tumour types. 3. Collaborating to harness transformational technologies, including computational pathology, circulating tumour DNA (ctDNA) testing, digital health and data science/AI. 4. Leveraging our global footprint – to make cancer therapies available to every eligible and appropriate patient. Product Disease Total Revenue Commentary Tagrisso (osimertinib) Lung cancer $5,799m, up 7% (9% at CER) Approved in 101 countries for the adjuvant treatment of patients with early-stage EGFRm NSCLC and in 99 countries for both the 1st- and 2nd-line treatment of advanced EGFRm NSCLC. Imfinzi2 (durvalumab) Lung cancer Bladder cancer Liver cancer $4,237m, up 52% (55% at CER) Approved in 87 countries in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiotherapy (CRT) and in extensive-stage small cell lung cancer (SCLC) in 85 countries. Also approved in combination with gemcitabine and cisplatin as treatment for patients with locally advanced or metastatic biliary tract cancer (BTC) in 59 countries, and in unresectable hepatocellular carcinoma (uHCC) in combination with Imjudo in 41 countries (Imfinzi monotherapy also approved in certain countries). Also approved in combination with Imjudo and platinum-based chemotherapy for NSCLC in 27 countries, and for previously treated advanced bladder cancer in some countries. Lynparza (olaparib) Ovarian cancer Breast cancer Pancreatic cancer Prostate cancer $3,056m, up 2% (4% at CER) Approved in 97 countries as maintenance therapy for platinum-sensitive relapsed ovarian cancer and 1st-line BRCAm ovarian cancer, and in 94 countries with bevacizumab for homologous recombination repair deficient (HRD)-positive advanced ovarian cancer. Approved in 97 countries for gBRCAm, HER2-negative early breast cancer (approved in the metastatic setting in 80 countries). Approved in 94 countries for gBRCAm metastatic pancreatic cancer. Approved in 96 countries for homologous recombination repair (HRR) gene-mutated mCRPC (BRCAm only in certain countries) and in 59 countries with abiraterone for 1st-line mCRPC. Calquence (acalabrutinib) Mantle cell lymphoma (MCL) Chronic lymphocytic leukaemia (CLL) $2,514m, up 22% (23% at CER) Approved in 89 countries for the treatment of CLL and in 46 countries for the treatment of adult patients with relapsed or refractory MCL who have received at least one prior therapy. Enhertu (trastuzumab deruxtecan) Breast cancer Gastric cancer Lung cancer $1,283m, up 113% (114% at CER) Approved in more than 55 countries for HER2-positive metastatic breast cancer following one or more prior anti-HER2-based regimen. Also approved in more than 40 countries for HER2-low metastatic breast cancer following chemotherapy. Approved in more than 30 countries for previously treated HER2-mutant metastatic NSCLC and HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. Orpathys (savolitinib) Lung cancer $46m, up 37% (44% at CER) Approved in China and Macau for treatment of locally advanced or metastatic NSCLC with MET gene alterations. Truqap (capivasertib) Breast cancer $6m Approved in the US in combination with Faslodex (fulvestrant) for treatment of patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA, AKT1 or PTEN gene alterations following disease progression or recurrence. Other products Zoladex (goserelin acetate implant) Prostate cancer Breast cancer $986m, up 3% (9% at CER) Faslodex (fulvestrant) Breast cancer $297m, down 11% (6% at CER) 2 Imfinzi Total Revenue includes revenue of Imjudo which commenced in 2022. Key marketed products Therapy Area Review / Oncology AstraZeneca Annual Report & Form 20-F Information 2023 17 Strategic Report Corporate Governance Financial Statements Additional Information |
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2023 review – strategy in action Lung cancer Scientific advances are strengthening the potential of our medicines to offer cure and long-term survival in lung cancer with a focus on early detection and precision medicine. Our comprehensive portfolio includes leading medicines Tagrisso, Imfinzi, Imjudo, Enhertu and Orpathys, along with a promising pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca lung cancer data were featured in four plenary presentations at major medical congresses this year. > Positive results from the FLAURA2 Phase III trial showed Tagrisso with the addition of chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus Tagrisso monotherapy in advanced epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC) and was ultimately granted Priority Review in the US based on these results. Furthermore, positive overall survival results from the ADAURA Phase III trial showed Tagrisso achieved an unprecedented overall survival benefit for adjuvant early-stage EGFRm NSCLC, becoming the first Phase III trial to demonstrate survival benefit in this setting. > We reported positive results from the TROPION-Lung01 Phase III trial which showed that Dato-DXd demonstrated a statistically significant PFS benefit versus docetaxel in patients with previously treated locally advanced or metastatic NSCLC, and a clinically meaningful benefit in those with non-squamous tumours. We also reported results from TROPION-Lung02 and TROPION-Lung04 Phase Ib trials which showed Dato-DXd in combination with immunotherapy (pembrolizumab or Imfinzi, respectively), with or without chemotherapy, demonstrated encouraging responses and no new safety signals in the 1st-line advanced NSCLC setting. Dato-DXd is jointly developed and commercialised with Daiichi Sankyo. > Positive Phase III results from the AEGEAN Phase III trial showed Imfinzi significantly improved event-free survival in patients with NSCLC, increasing the time patients lived without recurrence or progression before and after surgery, and regulatory submission was accepted in the US based on these results. Additionally, Imfinzi in combination with Imjudo was approved in the EU for patients with metastatic NSCLC based on the POSEIDON Phase III trial. We also reported that the PACIFIC-2 Phase III trial for Imfinzi concurrently administered with CRT did not achieve statistical significance for PFS versus CRT alone in unresectable, Stage III NSCLC. > Enhertu became the first human epidermal growth factor receptor 2 (HER2)-directed therapy approved in the EU for patients with HER2-mutant advanced NSCLC based on results from the DESTINY-Lung02 trial. Enhertu is jointly developed and commercialised with Daiichi Sankyo. > Our novel immuno-oncology bispecific development programme continued to advance with the initiation of the eVOLVE-Lung02 Phase III trial investigating volrustomig, which simultaneously targets PD-1 and CTLA-4, as a 1st-line treatment in combination with chemotherapy in metastatic NSCLC. Breast cancer We are aiming to redefine clinical practice and transform outcomes across all subtypes and stages of breast cancer. Ultimately, it is our ambition to contribute to eliminating breast cancer as a cause of death. Our comprehensive portfolio of approved medicines, including Truqap, Enhertu, Lynparza, Faslodex and Zoladex, and promising breast cancer medicines in development, including Imfinzi, Dato-DXd and camizestrant, leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. > Positive results from the TROPION-Breast01 Phase III trial showed that Dato-DXd provided a statistically significant and clinically meaningful PFS benefit versus investigator’s choice chemotherapy for patients with inoperable or metastatic HR-positive, HER2-low or negative metastatic breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. Updated results from the BEGONIA Phase Ib/II trial showed that Dato-DXd in combination with Imfinzi demonstrated robust and durable tumour responses in the 1st-line treatment of patients with metastatic triple-negative breast cancer. > Our newest Oncology medicine, Truqap, was approved in the US in combination with Faslodex as the first AKT-inhibitor for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with certain gene alterations following disease progression or recurrence, based on the CAPItello-291 Phase III trial. The US regulatory submission was granted Priority Review in June 2023. > Enhertu was approved in the EU and China as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer based on the DESTINY-Breast04 Phase III trial. > Two Phase III trials (CAMBRIA-1 and CAMBRIA-2) were initiated to investigate camizestrant, our potential next-generation selective estrogen receptor (ER) degrader, as an adjuvant therapy for patients with ER-positive, HER2-negative early breast cancer. Genitourinary/Gynaecological cancers In genitourinary cancers, we aim to transform treatment paradigms through the delivery of innovative treatments to help many more patients than today, including establishing Lynparza plus abiraterone and prednisone as a standard of care (SoC) in 1st-line metastatic castration-resistant prostate cancer (mCRPC). In gynaecological (GYN) cancers, we will continue to redefine survival expectations, introducing new medicines beyond ovarian cancer across multiple GYN tumours, expanding into endometrial with Imfinzi and into cervical cancer. > Positive results from the DUO-O Phase III trial showed treatment with a combination of Lynparza, Imfinzi, chemotherapy and bevacizumab demonstrated a statistically significant improvement in PFS versus chemotherapy plus bevacizumab in patients with advanced ovarian cancer without tumour breast cancer gene (BRCA) mutations. Additionally, results from the DUO-E Phase III trial showed that Imfinzi plus chemotherapy in combination with Lynparza reduced the risk of disease progression or death versus chemotherapy in advanced or recurrent endometrial cancer, becoming the first global Phase III trial of immunotherapy plus poly (ADP-ribose) polymerase (PARP) inhibition to demonstrate clinical benefit in this setting. > Lynparza plus abiraterone and prednisone was approved in the US and Japan for the treatment of BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer, based on the Phase III PROpel trial. > Our next wave of potential new medicines includes saruparib, a PARP1 selective agent being investigated in combination with novel hormonal agents in metastatic castrate-sensitive prostate cancer (EvoPAR-Prostate01 Phase III trial), and volrustomig, a potential new treatment being tested in advanced cervical cancer (eVOLVE-Cervical Phase III trial). Therapy Area Review Oncology continued Over 30m The global burden of cancer is expected to grow, with over 30 million newly diagnosed patients estimated by 2040. Two thirds of those patients are expected to be in low-to-middle income countries. 18 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Gastrointestinal cancers We have a broad and robust development programme for the treatment of gastrointestinal cancers in many stages and disease types, including several positive results as well as approvals across multiple medicines. > We reported positive high-level results for the EMERALD-1 Phase III trial which showed Imfinzi, in combination with transarterial chemoembolisation (TACE) and bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in PFS versus TACE alone in liver cancer patients eligible for embolisation. This is the first global Phase III trial to show improved clinical outcome for systemic therapy in combination with TACE in this setting, and the trial continues to follow the secondary endpoint of overall survival. > Positive results from the MATTERHORN Phase III trial showed treatment with Imfinzi, in combination with standard of care (SoC) FLOT neoadjuvant chemotherapy, significantly improved pathologic complete response versus neoadjuvant chemotherapy in gastric and gastroesophageal junction cancers. > Imfinzi was approved in China for the 1st-line treatment of adult patients with unresectable or metastatic BTC in combination with chemotherapy, based on the TOPAZ-1 Phase III trial, and in the EU in combination with Imjudo for the treatment of patients with advanced or uHCC, based on the Phase III HIMALAYA trial. > We accelerated our ADC development programme, entering an exclusive global licence agreement with KYM Biosciences to develop AZD0901, a potentially first-in-class ADC targeting Claudin 18.2, with interim results showing promising early clinical efficacy. > For our novel bispecific programme we initiated the ARTEMIDE-Biliary01 Phase III trial, assessing our novel anti-PD-1/ anti-TIGIT bispecific antibody rilvegostomig, in combination with chemotherapy, in patients with biliary tract cancer. Blood cancers In haematology, we are using our six scientific platforms to develop and test novel investigational agents designed to target underlying drivers. Calquence, our next-generation BTK inhibitor, has treated 50,000 patients globally with approvals in 89 countries across multiple haematological diseases. > Calquence was approved for the first time in China for the treatment of CLL or SLL, based on the ASCEND global Phase III trial and a Phase I/II trial in China. > The tablet formulation of Calquence was approved in the EU for CLL and is designed to be co-administered with gastric acid-reducing agents, allowing greater patient and physician choice. > Promising interim results from a Phase I trial of AZD0486, a CD19/CD3 next-generation T-cell engager, demonstrated a high complete response rate in patients with relapsed or refractory follicular lymphoma with a manageable safety profile. > We initiated an exclusive global licence with LaNova Medicines for AZD0305 (LM305), a GPRC5D ADC, with the aim to accelerate our entry into multiple myeloma. Pan-tumour Together with Daiichi Sankyo, we are exploring the potential role of HER2-directed therapies in treating multiple solid tumour types. Positive results from the DESTINY-PanTumour02 Phase II trial showed Enhertu demonstrated clinically meaningful survival across multiple HER2-expressing advanced solid tumours including either biliary tract, bladder, cervical, endometrial, ovarian or pancreatic cancers or other tumours. In January 2024, Enhertu was granted Priority Review in the US for patients with a range of metastatic HER2-positive solid tumours. Digital healthcare solutions for early risk detection of lung cancer Through our A.Catalyst Network, AstraZeneca partnered with AI solution provider Qure.ai to use their AI platform qXR for detecting incidental lung nodules in routine chest x-rays. The solution is integrated with medical imaging systems, providing real-time malignancy risk score indicating risk of lung cancer that can be referred for further diagnostics. The technology, which has been implemented in 29 countries across 335 sites and has analysed more than 1.5 million chest x-rays (as at December 2023). As part of our partnership with the World Economic Forum’s EDISON Alliance, we have committed to screening five million patients for lung cancer risk using AI technology. Therapy Area Review / Oncology AstraZeneca Annual Report & Form 20-F Information 2023 19 Strategic Report Corporate Governance Financial Statements Additional Information |
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BioPharmaceuticalsOur ambition is to transform care for billions of people living with chronic diseases and deliver long-lasting immunity. We are working to intervene earlier to protect vital organs, slow or reverse disease progression, and achieve remission for often degenerative, debilitating and life-threatening conditions, so many more people can live better, healthier lives. The epithelium is the first line of defence in the human body; interaction between the airway epithelium and bacteria, viruses, allergens or pollution can result in the release of epithelial cytokines, driving inflammation. 20 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Therapy Area Review |
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Unmet medical need and world market 20 million deaths per year due to CVRM diseases. 4 of the 10 top causes of death globally are due to CVRM diseases. Unmet medical need and world market >40 million people worldwide have the immune-mediated diseases we are targeting, which carry a high disease burden. 3rd Chronic obstructive pulmonary disease (COPD) is the world’s third leading cause of death. Unmet medical need and world market Up to 4% of the population is immunocompromised and is at a higher risk of hospitalisation from COVID-19 than the general population. One billion cases of seasonal influenza annually. 1 Total Revenue from Andexxa is included within BioPharmaceuticals: CVRM for 2023 and 2022 reporting, previously reported within Rare Disease. The 2021 comparatives and growth rates shown for each therapy area have been calculated as though these changes had been implemented in 2021. 2023 overview > Forxiga, the number one SGLT2 inhibitor worldwide by volume, expanded its label from type 2 diabetes (T2D) and chronic kidney disease (CKD) to address cardiovascular (CV) death and hospitalisation for a broader range of heart failure (HF) populations. > Acquisition of CinCor and exclusive licence agreement with Eccogene bolstered the cardiorenal pipeline in hypertension, obesity, T2D and other cardiometabolic conditions. > Eplontersen demonstrated sustained benefit in Phase III trial for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) through 85 weeks. 2023 overview > Continued strong portfolio growth despite Symbicort patent expiry in the US, significant portfolio transformation, where key launch brands (Breztri, Fasenra, Tezspire, Saphnelo) represented circa 50% of the total portfolio at the year end. > Fasenra met the primary endpoint in the MANDARA Phase III trial demonstrating non-inferior rates of remission compared to mepolizumab in eosinophilic granulomatosis with polyangiitis (EGPA) patients. > Collaboration with Quell Therapeutics and proposed acquisition of Gracell Biotechnologies to boost the Immunology portfolio. 2023 overview > Beyfortus approved in the US and in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in infants and RSV lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season, respectively. > Supplemental Biologics Licence Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent accepted for review by the FDA. > Proposed acquisition of Icosavax bolsters the pipeline with investigational RSV and human metapneumovirus (hMPV) combination vaccine. > Emergency Use Authorisation in the US requested for the investigational long-acting antibody sipavibart for pre-exposure prophlylaxis of COVID-19. Our ambition is to improve care to save lives for the millions living with cardiovascular, renal and metabolic (CVRM) diseases, stop disease progression and, ultimately, pave the way to a cure. Total Revenue $10,628m up 15% (18% at CER) 2022: $9,211m 2021: $8,103m1 Cardiovascular, Renal & Metabolism Total Revenue $6,404m up 7% (10% at CER) 2022: $5,963m 2021: $6,049m Respiratory & Immunology Total Revenue $1,357m down 72% (71% at CER) 2022: $4,836m 2021: $4,779m Our ambition is to transform respiratory and immunology care for patients, moving beyond symptom control to disease modification, remission and, one day, cure. Our ambition is to develop and deliver transformative vaccines and antibodies, providing long-lasting immunity to millions, and supporting sustainable and resilient healthcare systems worldwide by reducing the burden of frequent infectious diseases. Vaccines & Immune Therapies AstraZeneca Annual Report & Form 20-F Information 2023 21 Strategic Report Corporate Governance Financial Statements Additional Information Therapy Area Review / BioPharmaceuticals |
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Diabetes $159.3bn High blood pressure $37.1bn Abnormal levels of blood cholesterol $19.2bn CKD $9.4bn Thrombosis $6.9bn CKD-associated anaemia $5.3bn Hyperkalaemia $0.9bn Other CV $58.0bn $286.1bn Annual worldwide market value Therapy area world market (MAT Q3-23) Key marketed products Product Disease Total Revenue Commentary Farxiga/Forxiga (dapagliflozin) T2D HF CKD $5,997m, up 37% (39% at CER) Forxiga is the number one prescribed SGLT2i worldwide by volume. In August, Forxiga received a 1st-line recommendation from the 2023 European Society of Cardiology Treatment Guidelines for HF across the range of ejection fractions. Brilinta/Brilique (ticagrelor) Acute coronary syndromes (ACS) $1,324m, down 2% (1% at CER) Brilinta plus aspirin is currently approved in more than 115 countries for the prevention of atherothrombotic events in adult patients with ACS and in 80 countries for the secondary prevention of CV events among high-risk patients who have experienced a heart attack. Lokelma (sodium zirconium cyclosilicate) Hyperkalaemia (HK) $412m, up 43% (46% at CER) Lokelma is now approved in 56 markets and is market leader by value and days-of-therapy volume in branded HK. Roxadustat Anaemia of CKD $276m, up 37% (44% at CER) Andexxa/Ondexxya (andexanet alfa) Factor Xa (FXa) inhibitor reversal agent $182m, up 14% (15% at CER) In June 2023, the Andexxa Phase IV (Annexa-I) trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care. Other products Crestor (rosuvastatin calcium) Dyslipidaemia Hyper-cholesterolaemia $1,110m, up 6% (12% at CER) Seloken/Toprol-XL (metoprolol succinate) Hypertension HF Angina $641m, down 26% (20% at CER) Onglyza family, (exenatide, Qtern, Symlin, Atacand and other established brands) n/a $227m, down 12% (8% at CER) Bydureon (exenatide XR injectable suspension) T2D $163m, down 42% (42% at CER) Wainua (eplontersen) polyneuropathy of hereditary transthyretin-mediated amyloidosis n/a On 21 December in the USA, Wainua (eplontersen) was granted its first-ever regulatory approval for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis. Cardiovascular, Renal & Metabolism Our strategy in CVRM Our ambition is to improve and save lives for the millions of people who are living with the complexities of CVRM diseases. > The impact of CVRM diseases on people, society and our planet is immense and growing, yet these diseases remain underdiagnosed, undertreated, and their interconnections under-recognised. > By understanding their interconnections and targeting the mechanisms that drive CVRM diseases, we will be able to detect, diagnose and treat people earlier and more effectively, stop disease progression and ultimately pave the way to a cure. > AstraZeneca is uniquely positioned to improve the outcomes of patients living with CVRM diseases today and tomorrow with our strong and expanding portfolio and a broad, deep and innovative pipeline delivered by a talented, passionate and diverse team. > We are building the leading CVRM business. 2023 review – strategy in action Our CVRM strategy is focused on four key areas: CV, renal, HF, and metabolic diseases. Cardiovascular (CV) CV disease is the leading cause of death and is responsible for approximately one third of all deaths globally. Our ambition is to reduce CV risk by improving hypertension control and reducing dyslipidaemia. > We continue to make a difference for patients with Brilinta, now approved in more than 124 countries for atherosclerosis and in 82 countries for high-risk patients with history of heart attack. > Andexxa is designed to bind to FXa inhibitors and rapidly reverse their anticoagulant effect in patients with major bleeds. In June, the Andexxa Phase IV (Annexa-I) trial stopped early after achieving pre-specified efficacy criteria versus usual care. The results of the trial have been presented at the World Stroke Congress and submitted for publication. > In February 2023, AstraZeneca completed the acquisition of CinCor, focused on developing baxdrostat, an investigational once-daily medication, for the treatment of hard-to-treat hypertension. > There is also a need for new approaches to stop progression of atherosclerosis caused by dyslipidaemia. AZD0780 is an oral inhibitor (oPCSK9) being developed for greater ease of use and enhanced convenience, aiming to drive reduction in LDL-C levels not achievable by statins alone. Renal Nearly 850 million people worldwide, or more than one in 10 people, are affected by kidney disease and more than 90% of people with CKD remain undiagnosed. Our ambition in CKD is to eliminate progression to kidney failure. > Forxiga is now approved in over 120 markets for the treatment of CKD. > In November, results from the real-world ZORA observational multicountry study showed that treating HK with the potassium Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Sales for CKD ($9.4bn) and CKD-associated anaemia ($5.3bn) fall outside the CVRM total market. All sales for CKD-associated anaemia ($5.3bn) fall within the CKD market and should not be double counted. Full details are given in the Development Pipeline and Patent Expiries of Key Marketed Products Supplements on our website, www.astrazeneca.com/ annualreport2023. Therapy Area Review BioPharmaceuticals continued 22 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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image to be updated binder Lokelma can allow patients with CKD or HF to maintain their lifesaving ren-in-angiotensin-aldosterone system inhibitor (RAASi) therapy which can prevent risk of progression to end-stage kidney disease. ZORA also showed patients were 2.5 times more likely to stay on RAASi therapy when treated with Lokelma versus those not prescribed a potassium binder. > At the American Society of Nephrology (ASN) 2023, the Phase IIb data for zibotentan/dapagliflozin was presented showing significant albuminuria reduction versus dapagliflozin alone in patients with CKD and proteinuria, supporting progress to Ph3 for High Proteinuria CKD. > Additional real-world evidence from the REVEAL-CKD, OPTIMISE-CKD and IMPACT-CKD studies highlighted the urgent need to act on the growing global burden and underdiagnosis of CKD. > In September 2023, the Global Patient Alliance for Kidney Health, a community-led alliance of 17 patient advocacy organisations, was launched with financial sponsorship from AstraZeneca. > We have an innovative early pipeline in renal, with AZD2373 under investigation as a precision medicine with the aim of preventing progression to kidney failure for people genetically at risk of kidney disease due to two apolipoprotein L1 (APOL1) alleles. Heart failure (HF) HF affects nearly 64 million people globally and is closely linked to other CVRM conditions. Our ambition is to eliminate HF as first cause of hospitalisation and cure HF with reduced ejection fraction. > The DELIVER Phase III trial showed that Forxiga reduced the risk of CV death or worsening HF across all left ventricular ejection fractions (LVEF). Forxiga is now approved for HF across all LVEF in 91 markets including the EU, US, China and Japan. In August 2023, Forxiga received a 1st-line recommendation in the 2023 European Society of Cardiology Treatment Guidelines for HF across the LVEF spectrum. > Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) and polyneuropathy (ATTRv-PN) are progressive systemic diseases leading to poor quality of life and eventually death. In September 2023, published results from the NEURO-TTRansform Phase III trial for eplontersen, a potential best-in-class, ligand-conjugated antisense oligonucleotide designed to treat all types of ATTR, demonstrated sustained benefit in the treatment of ATTRv-PN through 85 weeks. Together with our partner Ionis Pharmaceuticals, we received the first regulatory approval for Wainua (eplontersen) for the treatment of ATTRv-PN in the US in December 2023 with the EU and others expected to follow in 2024. > Wainua is also currently being evaluated in the Phase III CARDIO-TTRansform trial for ATTR-CM. > Our early pipeline is aimed at targeting key mechanisms in HF, including widespread inflammation, fibrosis, hypertrophy and microvascular dysfunction, as a major priority. Mitiperstat (AZD4831) is an investigational, oral myeloperoxidase (MPO) inhibitor intended to be complementary to SoC for patients diagnosed with HF with preserved ejection fraction. By targeting this key disease driver, the aim is to reduce inflammation and fibrosis, thereby increasing survival and reducing hospitalisation. Metabolism More than 650 million adults are living with obesity and the prevalence of diabetes is expected to rise to 783 million by 2045. Our ambition is to eliminate metabolic dysfunction-associated steatohepatitis, (MASH, previously NASH) fibrosis as a leading cause of liver failure. We also remain committed to treat beyond haemoglobin A1C in T2D. > Forxiga continues to help patients with T2D worldwide with approvals in more than 100 countries. In June 2023, Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) was approved in China and, in July 2023, Sidapvia (dapagliflozin and sitagliptin) was approved in Korea, both for the treatment of adults with T2D. > With one of the broadest clinical pipelines in MASH and cirrhosis, we are investigating new therapeutic modalities and precision medicine to target genetic drivers of disease in MASH to stop or slow disease progression. > In November, AstraZeneca and Eccogene entered into an exclusive licence agreement for AZD5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) currently in a US Phase I clinical trial for the treatment of obesity, T2D and other cardiometabolic conditions. For more information on our commitment in amyloidosis, see page 30. Improving diagnosis pathways in heart failure In the UK, we partnered with NHS Greater Glasgow and Clyde, the West of Scotland Innovation Hub and the University of Glasgow on PROJECT OPERA, an initiative designed to enhance digital diagnostic pathways for HF. In the pilot, PROJECT OPERA led to a reduction in echocardiogram waiting times to just six weeks from 12 months. Shorter wait times and earlier diagnosis can reduce the risk of hospitalisation and mortality for patients and avert approximately 8kg of CO₂ emissions per patient per year. We are now applying these learnings to other regions, including the rest of the UK, Spain, France, Germany, Mexico and China. AstraZeneca Annual Report & Form 20-F Information 2023 23 Strategic Report Corporate Governance Financial Statements Additional Information Therapy Area Review / BioPharmaceuticals / Cardiovascular, Renal & Metabolism |
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Asthma $25.0bn COPD $17.4bn Other $46.3bn $88.8bn Annual worldwide market value Therapy area world market (MAT Q3-23) Key marketed products Product Disease Total Revenue Commentary Symbicort (budesonide/ formoterol) Asthma COPD $2,362m, down 7% (4% at CER) Retained global market leadership. Only ICS/LABA approved as an anti-inflammatory reliever in 47 countries, with regulatory reviews anticipated in additional countries. Fasenra (benralizumab) Severe eosinophilic asthma $1,553m, up 11% (12% at CER) Currently approved as an add-on maintenance treatment for severe eosinophilic asthma in 80 countries including the US, EU and Japan. Breztri/Trixeo (budesonide/ glycopyrrolate/ formoterol) COPD $677m, up 70% (73% at CER) The fastest-growing global triple therapy1; approved in more than 73 countries, including the US, EU, Japan and China. More prominent role of fixed-dose triple therapies for early treatment, including mortality reduction benefits, reflected in 2023 GOLD report. Tezspire (tezepelumab) Severe asthma $345m, up 318% (319% at CER) Approved in more than 45 countries including the US, EU and Japan for the treatment of severe asthma without biomarker or phenotypic limitations. Regulatory reviews are ongoing in additional countries. Saphnelo (anifrolumab) Systemic lupus erythematosus (SLE) $280m, up 140% (141% at CER) Approved in 61 countries, including the US, EU and Japan. Included in 2023 European Alliance of Associations for Rheumatology (EULAR) recommendations for the management of SLE. Other products Pulmicort (budesonide) Asthma COPD Croup $713m, up 11% (17% at CER) Approved in more than 115 countries. Bevespi (glycopyrrolate/ formoterol) COPD $58m, stable at 0% (stable at 0% at CER) Approved in 46 countries, including the US, EU, Japan and China. Daliresp/Daxas (roflumilast) COPD $54m, down 72% (72% at CER) Approved in more than 50 countries, including the US and EU. 1 Global triple therapy market definition: Breztri, Enerzair, Trelegy, Trimbow. Respiratory & Immunology Our strategy in Respiratory & Immunology Our ambition is to transform care in respiratory and immune-mediated diseases by moving beyond symptom control to achieve disease modification, remission and, one day, cures for millions of patients worldwide. COPD We are working to eliminate COPD as a leading cause of death by transforming care through our broad portfolio. Our strategy is to: > Drive earlier diagnosis and prompt intervention with the most effective therapies to reduce mortality by preventing exacerbations and reducing cardiopulmonary risk. > Advance innovative biology and novel therapeutic platforms including next-generation biologics and orals that will enable us to slow disease progression, drive disease modification, and reverse the structural damage caused by the disease. Asthma Our ambition in asthma is to eliminate asthma attacks and achieve clinical remission, even in people with the most severe asthma. Our strategy is to: > Establish our anti-inflammatory reliever inhaled portfolio as the backbone of care. > Drive towards clinical remission with systemic biologics, and with pre-biologics for those patients not controlled on current therapies. > Introduce new modality therapies and bring forward precision medicine opportunities. Immunology Our ambition is to disrupt immunology by focusing on areas of high unmet medical need to drive clinical remission and eventually cure. Our strategy is to: > Lead in lupus. > Disrupt in established diseases with suboptimal treatment outcomes through precision medicine and novel mechanisms with a combination of our mid-stage internal pipeline and external collaborations, targeting diseases such as inflammatory bowel disease (IBD) and rheumatoid arthritis. > Invest in future transformative technologies with curative potential, such as complex biologics and cell therapy. New Respiratory We are also moving beyond asthma and COPD to address other respiratory diseases with significant unmet medical need, including severe viral lung infection, interstitial lung disease and idiopathic pulmonary fibrosis (IPF). 2023 review – strategy in action COPD Breztri, our triple inhaled therapy continues to gain market share, demonstrating strong volume growth within the growing fixed-dose combination triple class across major markets. In October 2023, patients received their first dose in the ATHLOS Phase III trial exploring Breztri’s ability to improve parameters that indicate cardiopulmonary function in COPD. Breztri is also being studied in asthma in two Phase III pivotal trials, KALOS and LOGOS. The OBERON and TITANIA Phase III trials of tozorakimab (anti-IL-33 mAb) are ongoing. In October 2023, patients received their first dose in the MIRANDA Phase III trial of tozorakimab. Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Therapy Area Review BioPharmaceuticals continued Full details are given in the Development Pipeline and Patent Expiries of Key Marketed Products Supplements on our website, www.astrazeneca.com/ annualreport2023. 24 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Compounds in early-stage clinical development include: > Mitiperstat, a selective MPO inhibitor in Phase II. A 10-fold increase in MPO (an enzyme associated with oxidative stress) concentration is associated with a 40% increase of risk of a COPD exacerbation. > AZD6793, an oral IRAK4 inhibitor that targets many of the key pathways triggered by bacterial and viral infections, smoke and other environmental factors in COPD patients. Asthma Symbicort maintained its position as the leading inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) globally by volume. Performance has been driven by strong growth in Emerging Markets, offset by generic erosion in the EU, US and Japan. In January 2024, Airsupra launched in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older, offering the first and only FDA approved anti-inflammatory rescue therapy to treat airway obstruction and inflammation concomitantly. AstraZeneca entered into a co-development agreement with Bond Avillion 2 Development in March 2018 for the development of the then drug candidate PT027 for asthma in the US. Fasenra, our first respiratory biologic has reached more than 119,000 patients with severe eosinophilic asthma. In April, we announced positive results from the MIRACLE Phase III trial, an efficacy and safety study of Fasenra in patients in Asia with a history of uncontrolled severe eosinophilic asthma. A Phase III trial in COPD, RESOLUTE, is also ongoing. Tezspire is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label. Tezspire’s strong performance continues following approval, gaining market share and achieving broad labels and reimbursement globally. Compounds in early-stage clinical development for asthma include: > AZD8630, an inhaled fragment antibody (inhaled biologic) in co-development with Amgen, that targets thymic stromal lymphopoietin. > Atuliflapon (AZD5718), a precision medicine approach in asthma with an oral 5-lipoxygenase-activating protein (FLAP) inhibitor that blocks the 5-lipoxygenase pathway, a clinically validated target which could offer an alternative for uncontrolled patients before becoming eligible for systemic biologics. > AZD4604, an inhaled JAK1 inhibitor that has the potential to block the effects of T2-high pro-inflammatory pathways (IL4/13, TSLP) and T2-lower pathways (IL6, IL17), many of which are poorly responsive to ICS in patients with asthma. New Respiratory The TILIA Phase III trial of tozorakimab in severe viral lower respiratory tract disease is ongoing. Other compounds in early-stage clinical development include: > AZD0292, an anti-pseudomonas aeruginosa mAb for the treatment of bronchiectasis. Immunology Saphnelo continues to grow rapidly during its launch phase and in June 2023, was included in the 2023 EULAR recommendations for the management of SLE, less than two years after first launch. Fasenra’s life-cycle management programme includes multiple clinical trials in eosinophilic diseases beyond the current severe asthma indication. In September 2023, we announced positive high-level results from the MANDARA Phase III trial which showed that Fasenra met the primary endpoint and demonstrated non-inferior rates of remission compared to mepolizumab in patients with EGPA who were receiving oral corticosteroids with or without stable immunosuppressive therapy. MANDARA is the first head-to-head trial of biologics in EGPA, comparing a single injection of Fasenra to three injections of mepolizumab, every four weeks. Full results from the trial were presented in November 2023 at the American College of Rheumatology Convergence meeting. Compounds in early-stage clinical development include: > AZD7798, a CCR9-depleting mAb. CCR9 is the main chemokine receptor for trafficking lymphocytes to the small intestine and considered central to the generation of small bowel inflammation in Crohn’s disease. In June 2023, we announced an agreement with Quell Therapeutics to develop, manufacture and commercialise engineered T-regulator (Treg) cell therapies for autoimmune diseases in order to reset immune tolerance and drive durable responses for patients. In 2023, we also announced the proposed acquisition of Gracell Biotechnologies. In June 2023, the clinical development programme for brazikumab, an anti-IL-23 mAb, in IBD was discontinued. Decarbonising respiratory care Chronic respiratory diseases are examples of the growing health impact of climate change. Poor air quality and extreme weather pose great risks to people living with asthma and COPD, and increase the number of people developing these diseases. We are dedicated to discovering and developing respiratory medicines that improve outcomes for patients as well as lowering the carbon footprint of respiratory care which stems from the use of medicines, doctor visits and hospital care. Early detection, diagnosis and disease control to avoid exacerbations are powerful ways to reduce overall healthcare resource utilisation and hospitalisations, and thus the carbon footprint of care. In addition to efforts to improve outcomes for patients, we are also decarbonising respiratory care by transitioning to climate-friendly inhaled medicines, moving our entire portfolio to a next-generation propellant with near-zero Global Warming Potential. AstraZeneca Annual Report & Form 20-F Information 2023 25 Strategic Report Corporate Governance Financial Statements Additional Information Therapy Area Review / BioPharmaceuticals / Respiratory & Immunology |
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$12.3bn Annual worldwide market value Therapy area world market (MAT Q3-23) Key marketed products Product Disease Total Revenue Commentary COVID-19 mAbs (tixagevimab and cilgavimab) COVID-19 $312m, down 86% (85% at CER) Authorised for pre-exposure prophylaxis (prevention) of COVID-19 (emergency use) in EU, Japan and many other countries. Approved for the treatment of COVID-19 in the EU and Japan. US emergency use authorisation for Evusheld revised in January 2023 to limit its use to when the combined frequency of non-susceptible variants in the US is ≤90%. Beyfortus (nirsevimab) RSV $262m, up 961% (945% at CER) (2022: $25m) Approved in the EU, US, UK, China and Canada. In collaboration with Sanofi. Sanofi has full commercial control of Beyfortus in the US. Vaxzevria (ChAdOx1-S [Recombinant]) COVID-19 $12m, down 99% (99% at CER) (2022: $1,875m) More than three billion vaccine doses have been released for supply to over 180 countries. Other products Synagis (palivizumab) RSV $546m, down 6% (2% at CER) Available in more than 100 countries outside the US. Sobi holds the US rights. Fluenz Tetra/ FluMist Quadrivalent (live attenuated influenza vaccine) Influenza $226m, up 30% (22% at CER) Approved in the US, EU and other countries. Daiichi Sankyo holds rights to FluMist Quadrivalent in Japan. Vaccines & Immune Therapies Our strategy in Vaccines & Immune Therapies We have a portfolio of medicines that includes vaccines for COVID-19 and influenza, long-acting antibodies for COVID-19 and RSV, and a pipeline of next-generation therapeutics and scientific platforms. We are optimising the potential of both vaccines and antibodies, providing long-lasting immunity and supporting sustainable and resilient healthcare systems worldwide by reducing the burden of frequent infectious diseases. Vaccines We are engineering next-generation vaccines that have the potential to generate potent and long-lasting immune responses. Advancing our ambition in vaccines, in January 2024 we entered a collaboration agreement with US-based biotechnology company Omniose to research vaccines for serious bacterial diseases, and we will have exclusive rights to Omniose’s proprietary bioconjugation platform for up to three years. Antibodies We are pioneering novel approaches to develop highly targeted, long-acting antibodies, using our half-life extension technology. We have significantly accelerated the speed at which we are able to identify potent antibody candidates, screening billions of antibody candidates in a matter of months. This complementary approach, with vaccines providing potential protection for those able to mount their own immune response, and antibody therapies for those who cannot, aims to ensure quality care for all. 2023 review – strategy in action Our Vaccines & Immune Therapies strategy is focused on reducing the burden of respiratory infections, including RSV, hMPV, COVID-19 and influenza. Respiratory syncytial virus Beyfortus is a single dose long-acting antibody (LAAB), developed and commercialised from an alliance between AstraZeneca and Sanofi, using AstraZeneca’s proprietary YTE half-life extension technology. In April 2023, AstraZeneca, Sobi and Sanofi updated and simplified their contractual arrangements relating to the development and commercialisation of Beyfortus in the US. In July 2023, Beyfortus was approved in the US for the prevention of RSV LRTD in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. In the US, Beyfortus is the first approved and recommended immunisation to prevent severe RSV disease in all infants under eight months by the CDC Advisory Committee on Immunization Practices. In January 2024, Beyfortus was approved in China for the prevention of RSV LRTI in neonates and infants entering or during their first RSV season and is anticipated to be available during the upcoming 2024 to 2025 RSV season. Regulatory applications are currently under review in Japan and other countries. Since its initial approval in 1998, Synagis has become a global SoC for RSV prevention and helps protect at-risk babies against RSV. In February 2023, new cost-effectiveness analysis of Synagis for the prevention of RSV infection in otherwise healthy Canadian infants born at 29-35 weeks’ gestational age, was presented at the 7th Respiratory Syncytial Virus Foundation Conference in Lisbon, Portugal. Our agreement with Sobi for the rights to Synagis in the US remains ongoing. In December 2023, AstraZeneca announced an agreement to acquire Icosavax, to bolster the Vaccines & Immune Therapies pipeline with a potential first-in-class, Phase III-ready, combination vaccine against RSV and hMPV, using an innovative, protein virus-like particle platform. COVID-19 AZD3152 is an investigational next-generation LAAB being developed to potentially protect vulnerable patients such as the immunocompromised from COVID-19, given that they may not have any other non-vaccine option. In July 2023, AstraZeneca shared positive high-level results from the Phase I safety cohort of the ongoing SUPERNOVA Phase I/III COVID-19 prevention trial, which showed that AZD3152 was generally well-tolerated and displayed pharmacokinetics consistent with Evusheld through to day 29. AstraZeneca licensed AZD3152 from RQ Biotechnology in May 2022. Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Therapy Area Review BioPharmaceuticals continued Full details are given in the Development Pipeline and Patent Expiries of Key Marketed Products Supplements on our website, www.astrazeneca.com/ annualreport2023. 26 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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image to be updated In October 2023, AstraZeneca announced new data from two extensive real-world evidence studies, which highlighted that immunocompromised people continue to face significant and disproportionate burdens from COVID-19, with substantially higher rates of severe COVID-19 outcomes compared to the general population. The INFORM and EPOCH studies were published in Lancet Regional Health Europe and Current Medical Research and Opinion, respectively. Data from INFORM were presented at the 12th Annual IDWeek Conference. Evusheld is a LAAB combination for the pre-exposure prophylaxis (prevention) and treatment of COVID-19. All Product Sales in 2023 were derived from sales of Evusheld in the first quarter. Vaxzevria was co-invented by the University of Oxford. Through a landmark agreement in 2020, Vaxzevria was developed and distributed by AstraZeneca at cost during the pandemic. Total Revenue for COVID-19 medicines (Vaxzevria and COVID-19 mAbs) declined significantly in 2023, due to the fulfilment of Vaxzevria contracts. Emergency Use Authorisation, based on positive results from the SUPERNOVA sub-study, was submitted in the US for the investigational LAAB sipavibart for pre-exposure prophylaxis of COVID-19 in an immunocompromised patient population. The International Immunocompromised Advocacy Network, an independent, community-led network of more than 44 patient advocacy organisations, was launched in October 2023 with initial financial sponsorship from AstraZeneca. Influenza Fluenz Tetra/FluMist Quadrivalent is a live quadrivalent vaccine, given as an intranasal spray. It is the first and only commercial intranasal flu vaccine that offers a needle-free alternative to traditional flu vaccinations. This year marked the 20th anniversary since the first regulatory approval of FluMist/Fluenz. In February 2023, AstraZeneca entered into an agreement with the US Government’s Department of Defense via the Medical Chemical, Biological, Radiological and Nuclear Defense Consortium to develop a ribonucleic acid (RNA)-based universal pandemic influenza vaccine. As part of this agreement, AstraZeneca will receive up to approximately $80 million over three years to develop the vaccine from preclinical research through a Phase I/II clinical study. In March 2023, Japan’s Ministry of Health, Labour and Welfare approved FluMist Quadrivalent for children aged two to 18 years. Daiichi Sankyo holds rights to FluMist Quadrivalent in Japan. In October 2023, the FDA accepted for review the Supplemental Biologics Licence Application (sBLA) for a self- or caregiver-administration option for FluMist Quadrivalent. For more information on the proposed Icosavax acquisition, see Business development on page 42. Working to bring medicines to patients faster Immunobridging is an approach to a clinical trial used to infer effectiveness of a new drug or vaccine candidate through an accepted surrogate measure for efficacy. Immunobridging trials – which are well-established for testing vaccines – can help accelerate access to important new therapies, without compromising tolerability. AstraZeneca is helping to lead the way with innovative immunobridging trials to accelerate access to next-generation monoclonal antibodies for COVID-19, where alternatives to running large efficacy trials are especially important given the rapid pace of viral evolution and the need to potentially protect those at highest risk for severe disease. AstraZeneca Annual Report & Form 20-F Information 2023 27 Strategic Report Corporate Governance Financial Statements Additional Information Therapy Area Review / BioPharmaceuticals / Vaccines & Immune Therapies |
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The dysregulation of the complement system, an essential part of the immune system, is a key driver of many devastating diseases. Targeting and inhibiting the complement system before it can trigger tissue damage or destruction can help restore balance. Therapy Area Review 2023 overview > Geographic expansion and pipeline diversification enabling continued C5 leadership and sustainability of complement franchise. > Advancing innovative therapies for non-complement mediated diseases with limited scientific progress or few therapeutic options. > Strategic collaborations to strengthen next-generation research capabilities: – Accelerating genomic medicine ambition via acquisition of Pfizer’s preclinical gene therapy portfolio; – Leveraging AI and new technologies to drive science-led innovation across drug discovery, clinical diagnostics and patient engagement. Total Revenue $7,764m up 10% (12% at CER) 2022: $7,053m 2021: $3,110m1 1 Total Revenue from Koselugo is included within Rare Disease for 2023 and 2022 reporting, previously reported within Oncology, and Total Revenue from Andexxa is included within BioPharmaceuticals: CVRM for 2023 and 2022 reporting, previously reported within Rare Disease. The comparatives and growth rates shown for each therapy area have been calculated as though these changes had been implemented in 2021. Rare Disease After more than two full years as Alexion, AstraZeneca Rare Disease, our medicines are helping patients in 70 countries. As we expand the reach of our medicines, our growing pipeline of investigational molecules represents continued innovation on behalf of rare disease patients. Our mission remains to transform the lives of people affected by rare diseases through the development and delivery of innovative medicines as well as supportive technologies and healthcare services. Unmet medical need and world market 400m people around the world are living with a rare disease. >10,000 estimated number of rare diseases; fewer than 10% have approved treatment options. For more information, see: Science and Innovation from page 34. Growth and Therapy Area Leadership from page 38. Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Therapy area world market (MAT Q3-23) $158.4bn Annual worldwide market value 28 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Our strategy in Rare Disease We are dedicated to improving the lives of those living with rare diseases, and the people who support them, through: > Advancing our leadership in complement therapies, while also building on our pioneering legacy of innovation to diversify our portfolio. > Collaborating with partners to leverage promising new modalities, platforms and technologies. > Enhancing science-led innovation across the enterprise to accelerate drug development and delivery. > Creating smart and efficient strategies that bring transformative medicines to new markets, reaching more patients in a sustainable and equitable way. Key marketed products Product Disease Total Revenue Commentary Soliris (eculizumab) Paroxysmal nocturnal haemoglobinuria (PNH) Atypical haemolytic uremic syndrome (aHUS) Generalised myasthenia gravis (gMG) Neuromyelitis optica spectrum disorder (NMOSD) $3,145m, down 16% (14% at CER) Approved in more than 50 countries for the treatment of patients with PNH, including the US, EU, Japan and China. Approved in more than 50 countries for the treatment of patients with aHUS, including the US, EU, Japan and China. Approved in more than 40 countries for the treatment of patients with gMG who are anti-acetylcholine receptor antibody-positive (AChR Ab+) including the US, EU, Japan and China. Approved in more than 45 countries for the treatment of adult patients with NMOSD who are anti-aquaporin-4 antibody-positive (AQP4 Ab+), including the US, EU, Japan and China. Ultomiris (ravulizumab) PNH aHUS gMG NMOSD $2,965m, up 51% (52% at CER) Approved in 60 countries for the treatment of patients with PNH, including the US, EU and Japan. Approved in 60 countries for the treatment of patients with aHUS, including the US, EU and Japan. Approved in more than 55 countries for the treatment of adult patients with gMG who are AChR Ab+, including the US, EU and Japan. Approved in more than 40 countries for the treatment of adult patients with NMOSD who are AQP4 Ab+, including the EU and Japan. Strensiq (asfotase alfa) Hypophosphatasia (HPP) $1,152m, up 20% (21% at CER) Approved in more than 50 countries for the treatment of certain patients with HPP, including the US, EU, Japan and Canada. Koselugo (selumetinib) Neurofibromatosis type 1 (NF1) Plexiform neurofibromas (PN) $331m, up 59% (60% at CER) Approved in more than 55 countries, including the US, EU and Japan. Kanuma (sebelipase alfa) Lysosomal acid lipase deficiency (LAL-D) $171m, up 7% (8% at CER) Approved in more than 45 countries, including the US, EU and Japan. Full details are given in the Development Pipeline and Patent Expiries of Key Marketed Products Supplements on our website, www.astrazeneca.com/ annualreport2023. AstraZeneca Annual Report & Form 20-F Information 2023 29 Strategic Report Corporate Governance Financial Statements Additional Information Therapy Area Review / Rare Disease |
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2023 review – strategy in action Sustained leadership in complement Alexion was the first company to translate the complement system into transformative medicines. We are continuing that legacy of leadership across multiple disease areas, leveraging AstraZeneca’s established footprint and expanding our global presence through Centres of Excellence to reach patients with high unmet medical need. 2023 performance was underpinned by consistent, durable and strong business growth, driven by continued patient demand in gMG, a progressive, neuromuscular disease which can impact mobility, speech and breathing, together with launches in new markets and successful conversion from Soliris to Ultomiris across shared indications. The EU and Japan approved our long-acting C5 inhibitor Ultomiris for the treatment of adults with NMOSD, a progressive autoimmune disease that impacts the central nervous system. With no relapses observed in the pivotal CHAMPION-NMOSD trial, Ultomiris marks a significant advance for NMOSD patients, offering dosing every eight weeks and the potential to live relapse-free. Regulatory reviews for Ultomiris for the treatment of NMOSD are ongoing in additional countries, including the US. We have further expanded access to our first-in-class C5 inhibitor Soliris for patients with rare neurological diseases; Soliris has the potential to improve outcomes and quality of life for these patients and their families. Soliris has been approved in the EU and Japan for certain paediatric patients with refractory gMG, and was approved in China for the treatment of certain adults with gMG and certain adults with NMOSD. Additional clinical trials of Ultomiris are ongoing in several disease areas where the complement pathway is thought to play a role, including Phase III trials in haematopoietic stem cell transplant-associated thrombotic microangiopathy and in cardiac surgery-associated acute kidney injury. Following review of high-level results, we made the decision to discontinue a Phase II/III clinical trial evaluating Ultomiris in adults with dermatomyositis. No new safety findings were observed, and the safety data are consistent with the established safety profile of Ultomiris. Beyond Soliris and Ultomiris We are developing a broad portfolio of potential medicines that target various components of the complement system, with opportunities to pursue indications across a wide range of therapeutic areas of interest, including haematology, nephrology, neurology and ophthalmology. We are exploring the ability to treat earlier-line and broader gMG patient populations in a Phase III trial with gefurulimab (ALXN1720), a next-generation C5 inhibitor that is self-administered subcutaneously. We are also evaluating potential treatments for certain rare nephrology conditions, including ALXN2030, an investigational small interfering RNA targeting the complement C3 protein. Factor D inhibition We have a robust portfolio of investigational medicines that inhibit the complement protein Factor D, including small molecule oral assets with potential broad application across several disease areas. Voydeya (danicopan) received the first-ever regulatory approval in Japan for the treatment of a subset of adults with PNH to be used in combination with C5 inhibitor therapy. The approval of Voydeya, a first-in-class, oral, Factor D inhibitor, was based on the positive results from the pivotal ALPHA Phase III trial; results from the 12-week primary evaluation period of the trial were published in The Lancet Haematology. Voydeya was developed as add-on to proven SoC Ultomiris or Soliris to address the needs of the subset of patients (approximately 10-20%) with PNH who experience clinically significant extravascular haemolysis (EVH) while treated with a C5 inhibitor. Regulatory submissions for Voydeya are currently under review with multiple global health authorities. Alexion is also evaluating Voydeya in an ongoing Phase II trial as a potential monotherapy for geographic atrophy, a chronic and progressive eye disease. Additional investigational, oral Factor D inhibitors in clinical development are: > Vemircopan (ALXN 2050) in ongoing Phase II clinical trials in a number of rare diseases. > ALXN2080 in an ongoing Phase I trial. Expanding beyond complement We have continued to expand our rare disease focus with novel assets for non-complement mediated diseases. Amyloidosis is a group of complex rare diseases, with varying types and severities. Alexion and AstraZeneca are advancing the industry’s largest amyloidosis pipeline, across a broad range of modalities, to address the spectrum of patient need across multiple disease subtypes. Amyloid light chain (AL) amyloidosis In AL amyloidosis, misfolded abnormal proteins build up and form toxic amyloid deposits in organs throughout the body (including the heart and kidneys), causing significant organ damage and failure that may ultimately be fatal. Anselamimab (CAEL-101), a potentially first-in-class fibril-reactive mAb for the treatment of AL amyloidosis, is currently being evaluated in the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme in combination with SoC therapy in AL amyloidosis. Two parallel Phase III trials in patients with Mayo Stage IIIa and Stage IIIb disease, respectively, are ongoing. Transthyretin amyloidosis (ATTR) ATTR cardiomyopathy (ATTR-CM) is a systemic, progressive and fatal condition that leads to HF and a high rate of fatality within four years from diagnosis. Alexion holds an exclusive licence from Neurimmune to develop and commercialise ALXN2220 (NI006), an investigational mAb that specifically targets misfolded transthyretin. ALXN2220 is designed to directly address the pathology of ATTR-CM by enabling removal of amyloid fibril deposits in the heart, with the potential to treat patients with advanced ATTR-CM. Positive Phase I results were published in the New England Journal of Medicine for ALXN2220 in the treatment of patients with ATTR-CM and HF, indicating a favourable safety profile as well as a substantial reduction of cardiac amyloid deposition over a 12-month period, and a Phase III trial of ALXN2220 is underway. Positive high-level results from the Japan Phase III trial of acoramidis (ALXN2060) in adults with ATTR-CM showed consistency to those in the global BridgeBio ATTRibute-CM Phase III trial, including survival, cardiac-related hospitalisations and other measures of improved functions and quality of life at 30 months. Alexion holds an exclusive licence from BridgeBio’s subsidiary, Eidos Therapeutics, Inc., to develop and commercialise acoramidis in Japan; this trial in Japan was conducted to support local registration. 70 countries Our Rare Disease medicines are now approved in 70 countries. 30 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Therapy Area Review Rare Disease continued |
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Alexion and AstraZeneca are uniquely positioned to advance an industry-leading suite of next-generation genomic medicines and platforms, with the objective to develop innovative therapies with improved safety and efficacy profiles. Thousands of diseases – including 80% of known rare diseases – are believed to be caused by a genetic mutation. Genomic medicines are designed to treat or cure these diseases through the addition, alteration or inactivation of the malfunctioning gene. Supported by recent strategic acquisitions, investments and collaborations, Genomic medicine Accelerating our ambition to become a leader in genomic medicine and deliver potentially transformative medicines to patients. Neurofibromatosis Type 1 (NF1) Plexiform Neurofibromas (PN) NF1 PN is a rare, progressive, genetic condition impacting multiple body systems characterised by benign tumours called plexiform neurofibromas, which develop along nerve sheaths throughout the body. In May 2023, Koselugo was approved in China for paediatric patients with NF1 and PNs. Wilson disease We announced the difficult decision to terminate the ALXN1840 programme in Wilson disease based on review of results from Phase II mechanistic trials and discussions with regulatory authorities. Rare cancers Rare cancers account for approximately 27% of cancer deaths and have a lower five-year survival rate than most common cancers, representing a significant unmet medical need. For example, glioblastoma is a rare brain cancer that is almost always fatal, with a five-year overall survival rate of less than 10% following diagnosis. We are partnering with colleagues across AstraZeneca to follow the science and identify opportunities where we can leverage our expertise and infrastructure to deliver transformative outcomes for patients. Hypophosphatasia (HPP) HPP is a rare, genetic metabolic disease characterised by impaired bone mineralisation, muscle weakness and other systemic manifestations of the disease, which can lead to death in infants and significant disability at any age. We completed a Phase I trial in adult patients with HPP for efzimfotase alfa (ALXN1850), our next-generation alkaline phosphatase enzyme replacement therapy. Efzimfotase alfa is designed to help reduce the treatment burden for patients via more convenient dosing and subcutaneous administration. A Phase III trial has been initiated to evaluate efzimfotase alfa in adolescent and adult HPP patients who have not previously been treated with Strensiq. Find more information about our genomic medicine ambition on our website, www.astrazeneca.com/ genomic-medicine. Therapy Area Review / Oncology AstraZeneca Annual Report & Form 20-F Information 2023 31 Strategic Report Corporate Governance Financial Statements Additional Information Therapy Area Review / Rare Disease AstraZeneca Annual Report & Form 20-F Information 2023 31 |
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A talented team delivering our strategic priorities sustainably, supporting scientific innovation and commercial success. Science and Innovation We are focused on science and innovation, from discovery through to development and life-cycle management, and on improving productivity and outcomes for patients. We have three therapy area-focused R&D organisations – Oncology, BioPharmaceuticals and Rare Disease. Key topics covered Summary and performance indicators Research & Development Bioethics Development pipeline overview Growth and Therapy Area Leadership We are focused on realising the potential of our pipeline and medicines that deliver sustainable growth. Our Commercial regions align product strategy and commercial delivery while our Operations function manufactures and delivers our medicines. Key topics covered Summary and performance indicators Sales and marketing Operations IT and IS resources Business development People and Sustainability We are committed to our people, ensuring that AstraZeneca remains a great place to work. We are also enhancing our pledge to the planet and, through development of our health equity strategy, to society. Key topics covered Summary and performance indicators People Sustainability > Access to healthcare > Environmental protection > Ethics and transparency Our business is organised to deliver our Growth Through Innovation strategy. Our R&D and Commercial functions promote accelerated decision making and the launches of new medicines across our therapy areas. 32 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Business Review |
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5 9 6 7 10 8 4 3 1 2 5 9 6 7 10 8 4 3 1 2 US 20% Emerging Markets 38% Europe 35% Established Rest of World 7% 10% 6% 2% -14% Global reach and presence Strategic R&D centres1 1. Gaithersburg, MD, US 2. Boston, MA, US 3. Cambridge, UK (HQ) 4. Gothenburg, Sweden 5. Shanghai, China Other R&D centres with discovery research labs1 6. San Francisco, CA, US 7. Santa Monica, CA, US 8. New Haven, CT, US 9. Macclesfield, UK 10. Amsterdam, Netherlands We are using our distinctive scientific capabilities to deliver a pipeline of life-changing medicines. Our R&D functions enable the launches of new medicines across our therapy areas. We work to meet our goals through innovation and commercial excellence. We have an active presence in 85 countries and sell our products in more than 125 countries. Science and Innovation 13,000+ R&D employees across our global sites 27 Operations sites in 16 countries Growth and Therapy Area Leadership Operations sites1 Total Revenue growth by reporting region2 People and Sustainability Our success depends on recruiting, retaining and developing talented people while operating in a responsible and sustainable way to build a healthy future for people, society and the planet. Employees by reporting region 50.1% of our senior roles are filled by women 89,900 employees $45.8bn Total Revenue 1 Inclusive of Alexion and Neogene. 2 Actual growth percentage. Europe US Emerging Markets Established Rest of World Business Review / Global reach and presence AstraZeneca Annual Report & Form 20-F Information 2023 33 Strategic Report Corporate Governance Financial Statements Additional Information |
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Discovery and early-stage development 40% Late-stage development 60% Research & Development 2023 2022 2021 6 6 9 6 NME Phase II starts/progressions 2023 2022 2021 31 38 27 31 NME and major LCM submissions 2023 2022 2021 24 23 23 24 NME and major LCM Phase III investment decisions 2023 2022 2021 25 34 22 25 NME and major LCM approvals Science and Innovation Performance indicators By measuring both Phase II and Phase III pipeline progressions, we focus on both near-term and longer-term delivery. Phase II NME starts ensure the ongoing robustness and future stability of the pipeline (and reflect the outcome of nearer-term strategic investment decisions). Phase III investments measure assets that will deliver nearer-term value (and reflect the outcome of longer-term strategic investment decisions). Submission and approval metrics demonstrate the advancement of this innovation through filing and approval in four major markets (US, EU, China and Japan). Research & Development In 2023, we continued to progress our science and our pipeline in a way that reflected our ongoing commitment to sustainability and maintaining an ethical business culture. Summary and performance indicators We are using our distinctive scientific capabilities to deliver a pipeline of life-changing medicines. Our performance in 2023 > Invested $10.9 billion in our R&D. > Three first approvals for new medicines: Airsupra, Truqap and Wainua. Voydeya was approved in January 2024. > 56 regulatory events and 30 pipeline progressions. > 178 pipeline projects, of which 160 are in the clinical phase of development. > More than 2,000 people working in our Discovery Centre in Cambridge, UK. > Strategic R&D centre in China. > Published 808 manuscripts with 158 in ‘high-impact’ journals. > Invested in new modalities such as cell and gene therapies, epigenetics and oligonucleotides. > Launched Evinova to accelerate innovation. Our R&D resources Our strategic R&D centres The Discovery Centre in Cambridge, UK, is located in a bioscience hotspot and is now occupied by more than 2,000 employees working in drug discovery and development across our therapy areas. Gaithersburg is our largest R&D site in the US and our presence in Maryland contributes to the state’s economy while supporting the growth of the life sciences industry. Supporting the entire life-cycle of our medicines, our Gothenburg site facilitates interactions between drug, device, diagnostics and digital health companies in a growing life science ecosystem. In 2026, we plan to begin the phased occupation of our new strategic R&D centre and Global Alexion headquarters in Boston. The centre is located in Kendall Square, at the heart of one of the world’s top biotech research and technology innovation centres. Our centre in Shanghai recognises the importance of the China market to our future growth and our focus on bringing Chinese innovation to the world. Investing in R&D In 2023, R&D expenditure was $10,935 million (2022: $9,762 million; 2021: $9,736 million), including Core R&D costs of $10,267 million (2022: $9,500 million; 2021: $7,987 million). In addition, we spent $2,530 million on acquiring product rights (such as through in-licensing) (2022: $2,051 million; 2021: $27,042 million). We also invested $212 million on the implementation of our R&D restructuring strategy (2022: $111 million; 2021: $223 million). Allocations of spend by early- and late-stage development are shown in the chart to the left. 2023 investment increased to support our late-stage portfolio: in Oncology, camizestrant, volrustomig and our ADC portfolio; in BioPharmaceuticals, Breztri/ Trixeo and tozorakimab. The Eccogene agreement exclusively licensed AZD5004, with spend on the programme and trial planning. COVID-19 investment continued with AZD3152 SUPERNOVA trial for prophylaxis and treatment options. We also invested in new modalities and technologies with acquisitions of Pfizer genomic assets, Neogene and the Cellectis cell therapy agreement. Business Review continued 34 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Our R&D in 2023 In 2023, we continued to progress our science, focusing on four key areas of transformative science. Our scientists published 808 manuscripts with 158 in ‘high-impact’ peer-reviewed journals, each with an impact factor exceeding 15 (Thomson Reuters five-year impact factor score). The ongoing high impact continues to reflect the quality of, and drive to share, our science. Enhancing our understanding of disease biology Advancing our understanding of disease biology is helping uncover novel drivers for the diseases we aim to prevent, treat and in the future, cure. Selecting the right target remains the most important decision in drug discovery. 2023 developments included: > Demonstrating the power of combining genomics with proteomics to discover how rare changes in genes affect plasma proteins by using data from more than 50,000 individuals in the UK Biobank. This study, published in Nature, is the largest of its kind. > Together with academic and biopharmaceutical industry partners, we launched Together For Change, a 10-year initiative to close the gap on historical health care inequities, education and training by building more diversity in genetic research, accelerating education pathways, and improving genomic tools for people of African ancestry. > Publishing in several high-impact journals, including Nature, reflecting our progress in understanding the role that tumour-associated myeloid cells with immunosuppressive properties play in poor patient outcomes and in treatment resistance in cancer. > Establishing a new world-class functional genomics laboratory with the Medical Research Council and the Milner Therapeutics Institute at the University of Cambridge to accelerate drug discovery and further the UK’s global genomics leadership. Innovative collaborations such as this allow us to share resources and expertise to advance science for the benefit of patients. > Working with Ad Scientiam to develop digital biomarkers to improve symptom tracking for rare neurological and neuromuscular diseases. Creating the next generation of therapeutics We continue to design new ways of targeting the drivers of disease. The diversity of technologies applied in our early pipeline is exemplified by the increased number of new modalities entering clinical development, including ADCs, antibodies (e.g. bispecific, inhaled fragment, cell depleting monoclonal), cell therapies, genomic medicines, PROTACs, oligonucleotides and T-cell engagers. 2023 developments included: > Advancing novel engineered Treg cell therapies designed to induce durable immune tolerance as a potential cure for serious immune-mediated diseases. This is being explored in type-1 diabetes (T1D) and inflammatory bowel disease (IBD) in a new strategic collaboration with Quell Therapeutics. > Demonstrating the strength of our proprietary ADC technology by advancing AZD9592 (epidermal growth factor receptor (EGFR) cMET bispecific) and AZD5335 (FR ) into the clinic. > Advancing our ambition to bring cell therapies to solid tumours by disclosing two novel CAR-Ts – AZD0574 (STEAP2) and AZD6422 (Claudin 18.2) – designed utilising our innovative armouring technology to resist the immunosuppressive tumour microenvironment, and progressing our first T-cell receptor therapies – NT-125 (fully individualised) and NT-175 (TP53) – into the clinic through Neogene. > Accelerating our cell therapy and genomic medicine ambitions in areas of high unmet medical need across oncology, immunology and rare diseases, via a collaboration and investment agreement with Cellectis to leverage gene editing technologies and manufacturing capabilities, via the proposed acquisition of Gracell, which includes a clinical-stage autologous BCMA/CD19 CAR-T therapy targeting haematologic malignancies and autoimmune diseases and a proprietary cell therapy manufacturing platform, and via the acquisition of a portfolio of preclinical rare disease gene therapies from Pfizer. Better predicting clinical success of our candidate drug molecules We are adopting a range of cutting-edge technologies, generating data that are more relevant to patients than previous methods, to help us predict the clinical effectiveness of our candidate drug molecules. 2023 developments included: > Collaborating with Verge Genomics to more efficiently identify and validate therapeutic targets for rare diseases by leveraging Verge’s AI-enabled platform trained on patient tissue samples. > Under our collaboration with GRAIL, new data showed the promise of the GRAIL methylation assay for detecting residual disease in blood cancer following treatment, with potential to inform early intervention strategies. > Collaborating with Qureight to leverage imaging data analytics and AI models to better understand how patients with rare and complex lung diseases could respond to novel drugs. > Pioneering the use of Quantitative Continuous Scoring (QCS), our novel, fully automated computational pathology solution, within our clinical trial portfolio. Early clinical studies have shown that QCS can identify the right patient populations suitable for targeted therapies, such as ADCs. > Publishing findings in Advanced Science that show our ability to develop novel microphysiological systems that can combine multiple cell types and reproduce the structures of functioning organs to accurately recreate key aspects of kidney biology in the lab for the first time. Pioneering new approaches to engagement in the clinic We are pioneering clinical innovation to design and deliver patient-centric clinical trials that improve the patient and site team experience while optimising the use of data, digital and AI to improve patient outcomes in clinical trials and beyond. 2023 developments included: > Publishing in Nature Medicine our 6R framework for implementing digital health technology in clinical trials based on qualitative research. This showed how technology is enabling a shift from the traditional physical site-based trial model, reducing the burden on patients and trial sites and enabling continuous data collection while driving more innovative trial designs. > Collaborating with existing UK NHS lung cancer screening programmes, research sites and investigators to identify COPD patients eligible for clinical trials. The initiative also strengthens our understanding of factors contributing to resilience and early disease development. > Launching Evinova to bring to market digital health solutions that are science-based, evidence-led and human-experience driven. Evinova will prioritise digital solutions to optimise clinical trial design and delivery. For more information on Quell, Cellectis, Gracell and Pfizer deals, see Business development on page 42. AstraZeneca Annual Report & Form 20-F Information 2023 35 Strategic Report Corporate Governance Financial Statements Additional Information Business Review / Science and Innovation |
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Science and Innovation Research use of human biological samples and genomic information We use human biological samples and genomic information for research into better understanding of diseases, improved diagnosis, and other healthcare improvements, as well as for the research and development of new medicines. We are committed to minimising the use of human foetal tissue (hFT) through scientific advancements. Permission is granted only when no other scientifically reasonable alternative is available, or there is a regulatory requirement. There were two new hFT approvals in 2023. To date, eight projects using hFT have been approved, and three projects are ongoing. Animals in research Animal studies remain a small, but necessary part of discovering, developing and licensing life-changing medicines. AstraZeneca is committed to the 3Rs (Replacement, Reduction and Refinement of animals in research) and has programmes to accelerate the development of new approach methodologies, which have potential to reduce and eventually replace the need for animals. We focus on robust experimental design and analysis to ensure the fewest animals are needed to achieve scientific objectives, with our scientists refining procedures and applying high standards of animal care. Animals were needed for in-house studies 122,768 times in 2023 (100,803 in 2022), and on our behalf in contract research studies 59,690 times (53,377¹ in 2022). In total, over 97% were rodents or fish, with the majority being mice (84%). The remainder is made up of rabbits, camelids, ferrets, dogs, pigs, non-human primates, chickens and sheep. Dogs and non-human primates make up less than 1% of the total. AstraZeneca does not conduct research using wild-caught non-human primates or great ape species. AstraZeneca is committed to transparency and is signatory to the Concordat on Openness on Animal Research (UK), the Openness Agreement on Animal Research and Teaching (Australia/New Zealand) and is contributing to the U.S. Animal Research Openness Initiative. AstraZeneca has an animal welfare assurance programme that ensures research conducted by third parties meets our high standards. Clinical trial transparency We believe that transparency enhances the understanding of how our medicines work, which benefits patients. We publish information about our clinical research, as well as the registration and results of all our interventional clinical trials and most non-interventional trials for all products – regardless of whether the results are favourable. This includes completed trials for marketed medicines, drugs in development and drugs where development has been discontinued. As of 31 December 2023, AstraZeneca had: > Shared anonymised individual patient-level data from 270 unique studies. > Responded to 364 requests from external researchers using our portal, www.vivli.org, and/or scientific collaborations, for our clinical data and reports to support their research. > Published 23 Anonymised Clinical Document Packages. > Published 401 Trial Result Summaries in accessible language and translated these into 63 languages for all study sites on the industry-wide portal www.trialsummaries.com. Bioethics ‘Bioethics’ means ethical issues arising from the study and practice of biological and medical science. Our key principles are set out in our Global Standard. BV For more information, see www.astrazeneca.com/ sustainability/resources.html. Business Review continued Driving innovation in clinical trials We are pioneering new approaches to clinical trials. By integrating data science, digital health technology and AI, we focus on clinical innovation to transform study design, improve patient outcomes, accelerate timelines, reduce burdens on patients and trial teams, and improve environmental sustainability. 1 2022 data has been restated due to system error causing figures to be overstated. 36 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Phase I1 Phase II1 Late-stage development1 Life-cycle management projects2 36 Oncology 42% Cardiovascular, Renal & Metabolism 19% Respiratory & Immunology 17% Vaccine & Immune Therapies 3% Rare Disease 11% Other 8% 27 Oncology 41% Cardiovascular, Renal & Metabolism 26% Respiratory & Immunology 15% Vaccine & Immune Therapies 0% Rare Disease 11% Other 7% 41 Oncology 56% Cardiovascular, Renal & Metabolism 12% Respiratory & Immunology 12% Vaccine & Immune Therapies 5% Rare Disease 15% Other 0% 74 Oncology 72% Cardiovascular, Renal & Metabolism 5% Respiratory & Immunology 16% Vaccine & Immune Therapies 0% Rare Disease 7% Other 0% 1 Includes NMEs and additional indications if the lead is not yet launched. 1 Includes NMEs and additional indications if the lead is not yet launched. 1 Includes NMEs and additional indications if the lead is not yet launched. 2 Only includes major LCM projects. Development pipeline overview 2023 was another remarkable year for pipeline development. We achieved 56 regulatory events, either submissions or approvals for our medicines in major markets, including three NME first approvals. This performance is backed by a healthy pipeline of high-potential medicines, with a total of 30 pipeline progression events, either NME Phase II starts or Phase III investment decisions, indicating our ability to deliver longer-term sustainable growth. Our pipeline comprises 178 projects, of which 160 are in the clinical phase of development. We have 17 NME projects in pivotal trials or under regulatory review, compared with 15 at the end of 2022. Also in 2023, 31 NMEs Green Labs Through our Green Labs programme and My Green Lab accreditation, we are reducing the environmental impact of our lab operations by engaging scientists and changing mindsets to design, develop and deliver new medicines in the most sustainable way. For more information, see Therapy Area Review from page 16. progressed to their next phase of development and 18 projects were discontinued: eight for poorer than anticipated safety or efficacy results and 10 as a result of a strategic shift in the environment or portfolio prioritisation. Accelerating our pipeline We are prioritising our investment in specific programmes, focusing on scientific innovation. As a result, we received 10 Regulatory Designations (Breakthrough Therapy, Priority Review or Fast Track) for eight new medicines that offer potential to address unmet medical need in certain diseases. We also secured Orphan Drug Designation for the development of six medicines to treat rare diseases. AstraZeneca Annual Report & Form 20-F Information 2023 37 Strategic Report Corporate Governance Financial Statements Additional Information Business Review / Science and Innovation |
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Sales and marketing Our growth is delivered by our Commercial teams, which employed 45,888 people at the end of 2023. During the year, we had an active presence in 85 countries and sold our products in more than 125 countries. In most markets, we sell our medicines through wholly-owned local marketing companies. We also sell through distributors and local representative offices. We market our products largely to primary and specialty care physicians. Summary and performance indicators We plan to meet our growth and profitability goals through innovation, commercial excellence and the creation of sustainable profitability. Our performance in 2023 > Total Revenue, comprising Product Sales, Alliance Revenue and Collaboration Revenue, increased by 3% (6% at CER) to $45,811 million. Total Revenue excluding COVID-19 medicines increased by 13% (15% at CER) to $45,488 million. > In the US, Total Revenue increased by 6% to $19,077 million and in Europe by 10% (8% at CER) to $9,611 million. > Total Revenue in Emerging Markets increased by 2% (9% at CER) to $12,025 million, with an increase in China of 1% (7% at CER) to $5,876 million. > Continued collaboration with payers to conclude outcomes- and value-based reimbursement models that improve patient outcomes and enable access to medicines. > Committed to high ethical standards: 296 employees and third parties were removed from their roles for breaches of sales and marketing regulations or codes. > Delivered 282 successful market launches. > Completed more than 20 major or strategically important business development transactions. Our regions We strive to meet our growth and profitability goals through commercial excellence in each of our global reporting regions. US As the tenth-largest prescription-based pharmaceutical company in the US, we have a 3.6% market share of US pharmaceuticals by sales value. Total Revenue increased by 6% in 2023 to $19,077 million, driven by the continued growth of our Oncology medicines and Farxiga. Recent launches in heart failure and chronic kidney disease drove an increase in market share. The US healthcare system is complex. Multiple payers and intermediaries influence patient access to branded medicines through regulatory rebates in government programmes and voluntary rebates paid to managed care organisations and pharmacy benefit managers for commercially insured patients. Significant pricing pressure is driven by payer consolidation, restrictive reimbursement policies and cost control tools, such as exclusionary formularies and price protection clauses. Many formularies employ ‘generic first’ strategies and/or require physicians to obtain prior approval for the use of a branded medicine where a generic alternative exists. The Inflation Reduction Act (IRA) of 2022 was passed to address affordability concerns. Farxiga has been selected in the first round of negotiations under the IRA, with the price taking effect in 2026, which is the same year we expect to lose exclusivity, and the impact is therefore expected to be manageable. We are evaluating our portfolio to understand timings associated with the potential inclusion of other medicines in future negotiations. We have a diversified product portfolio providing a broad spectrum of treatments in different therapy areas, allowing access for patients in need of our innovative medicines. Europe The total European pharmaceutical market was worth $248 billion in 2023. We are the seventh-largest prescription-based pharmaceutical company in Europe (see market definitions on page 232) with a 3.3% market share of pharmaceutical sales by value. Total Revenue was $9,611 million, up 10% (8% at CER). Growth and Therapy Area Leadership Key Performance Indicators Global Total Revenue by geography 2023 2022 2021 Total Revenue $m Actual growth % CER growth % Total Revenue $m Actual growth % CER growth % Total Revenue $m Actual growth % CER growth % US 19,077 6 6 17,920 47 47 12,228 38 38 Emerging Markets 12,025 2 9 11,745 (4) 1 12,281 41 36 Europe 9,611 10 8 8,738 9 21 8,050 45 40 Established Rest of World 5,099 (14) (8) 5,948 22 40 4,858 37 37 Total 45,811 3 6 44,351 19 25 37,417 41 38 38 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Business Review continued |
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Established Rest of World (RoW) Established RoW comprises Japan, Canada, Australia and New Zealand. In 2023, Total Revenue decreased by 14% (8% at CER) to $5,099 million, with sales in Japan down 10% (3% at CER) to $3,705 million. Emerging Markets With Total Revenue of $12,025 million, up 2% (9% at CER), AstraZeneca was the second-largest multinational pharmaceutical company, as measured by prescription sales, and the fifth fastest-growing top 10 multinational pharmaceutical company in Emerging Markets in 2023. In China, AstraZeneca is the largest pharmaceutical company in the hospital sector, as measured by sales value. In 2023, Total Revenue increased by 1% at actual rate of exchange (7% at CER) to $5,876 million (2022: $5,792 million). Roxadustat and Lokelma were renewed in the National Reimbursement Drug List (NRDL) and Xigduo, Tagrisso (ADAURA), Lynparza (PAOLA-1), Calquence, Soliris and Koselugo achieved listing for the first time. Since the implementation of VBP, several AstraZeneca brands have been impacted. In the most recent cycles of VBP implementation, Faslodex and Plendil were included. Additional AstraZeneca brands are expected to be included in future VBP cycles. There was some impact on demand in the second half of the year, mainly with oncology products, following the government anti-corruption campaign announced in July 2023. We were shocked following the Russian invasion of Ukraine in February 2022 and, since then, have provided practical support to ensure the safety, health and wellbeing of our employees. As a healthcare business, we are doing everything possible to ensure medical supply chains continue to operate and that patients in both countries are able to access our medicines, while complying with sanctions imposed on Russia. Healthcare in low- and middle-income countries BV AstraZeneca is committed to building resilient and sustainable health systems and improving equitable access to healthcare. By working collaboratively, we remove barriers to care and support the development and delivery of healthcare, particularly in low- and middle-income countries. We also adapt our programmes to suit local health systems and communities, contributing to health system capacity and resilience through training, education, prevention and early detection and diagnosis. AstraZeneca in Japan We are the second-largest prescription-based pharmaceutical manufacturer with a 6.1% value market share of Innovative Branded pharmaceutical sales by value, and have gained recognition as being a great place to work by the Great Place to Work Institute. Pricing and value of our medicines Increasing demand for healthcare means increasing pressure on health system budgets. This shift results in price and reimbursement restrictions in many markets. These pressures also result in movement from primary to speciality care, including rare diseases, which comprise a growing share of our portfolio. This pricing pressure, coupled with higher rates of inflation, means that we are unable to pass on the full impact of price increases. Pricing for our medicines seeks to reflect the value they bring to patients, payers and society, and the significant investment required for targeted treatment options. In our discussions with national, regional and local stakeholders, we base our pricing policies on four principles: sustainability, value, access and flexibility. We collaborate with payers to conclude innovative outcomes and value-based reimbursement models that improve patient outcomes and enable access to medicines across key therapeutic areas and geographic regions. We also offer a number of patient assistance programmes that help increase patients’ access to medicines and/or healthcare by reducing their cost burden. Responsible sales and marketing BV As outlined in the Code of Ethics on page 49, we are committed to high ethical standards. Our compliance professionals advise on, and monitor, adherence to our Code and policies, and work with local staff to ensure we meet our ethical standards. Nominated signatories review product promotional materials and activities to ensure compliance with applicable regulations and codes of practice, and that information is accurate and balanced. Group Internal Audit conducts audits of selected marketing companies. In 2023, we identified four confirmed external breaches across our Commercial business (2022: 10). There were 3,758 instances (instances can involve multiple people) of employee and third-party non-compliance with our policies (2022: 2,872). A total of 296 employees and third parties were removed from their role as a result of a breach (2022: 147) and 2,968 received warnings (2022: 3,326). We brief our Audit Committee quarterly on breach statistics, serious incidents and corresponding remediation. Breaches primarily consist of low-impact incidents. We continue to foster a culture where employees can speak their minds, with strong first-line oversight (and related reporting) as well as targeted second-line monitoring to identify concerns early, and use learnings to improve our programme. Anti-bribery and anti-corruption BV We do not tolerate bribery or any other form of corruption. Preventing bribery and corruption are a focus of our third-party risk management and due diligence processes, as well as our monitoring and audit programmes. We reinforce our commitment to ethical business conduct through our annual Code of Ethics training, which is delivered to all employees and relevant third parties. For more information, see Access to healthcare from page 47. For more information on our pricing policies, see our Sustainability Report on our website, www.astrazeneca.com/ sustainability. Business Review / Growth and Therapy Area Leadership AstraZeneca Annual Report & Form 20-F Information 2023 39 Strategic Report Corporate Governance Financial Statements Additional Information |
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Operations Our manufacturing and supply function continued to support our growth and pipeline, demonstrating excellence in product launches, quality and supply, with focus on progressive, sustainable processes. In 2023, we made strong progress against our Operations 2025 strategy, focused on scaling our capabilities to support business growth, leveraging the benefits of new manufacturing technology and digital innovation: > Delivered 282 launches across major markets. > Progressed our investments in manufacturing technologies, new modalities and digital innovations. > Five sites within the network – Nijmegen, Cairo, Cikarang, Lomas Verdes and Cotia – have delivered a 98% reduction in Scope 1 and Scope 2 GHG emissions (from 2015 baseline) measured against science-based targets. Ensuring quality and compliance As outlined in our Code of Ethics on page 49, we are committed to high ethical standards. As members of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), we adhere to their codes. Managing our supply chain During 2023, the world environment continued to be volatile and uncertain. The geopolitical events, trade sanctions, regulatory changes and high inflation are types of challenges that continue to require rapid operational responses. We continued to successfully meet our responsibilities to patients ensuring supply of our life-saving medicines with robust supply chain operations and reduced end-to-end supply lead times. We delivered increased demand and growth opportunities with flexibility and agility. As the regulatory environment evolves post COVID-19, AstraZeneca continues to deliver industry-leading quality performance. FDA recall data from 2020 to 2023 showed that AstraZeneca had zero recalls during this period. Supply chain finance AstraZeneca has a supply chain finance programme to support the cash flow of our external supply base. The programme is managed by Taulia Inc. (with funding provided by some of the Group’s relationship banks) and provides suppliers with visibility of invoices and payment dates via a dedicated platform. Suppliers can access this platform free of charge and have flexibility to select individual invoices for early payment. On election of an early payment, a charge is incurred by the supplier based on the period of acceleration, central bank interest rate and the rate agreed between Taulia Inc. and each supplier. All early payments are processed by the funders and AstraZeneca settles the original invoice amount with the funders at maturity of the original invoice due date. The programme operates in the US, UK, Sweden and Germany. As at 31 December 2023, the programme had 432 suppliers enrolled and a potential early payment balance of $112 million. We have a separate programme in China with 29 suppliers enrolled and a potential early payment balance of $11 million. Responsible supply chain BV All employees and contractors who source goods and services on behalf of AstraZeneca are expected to follow our Global Standard for Procuring Goods and Services. Through assessments and improvement programmes, including our third-party risk management system, we monitor supplier compliance with our published Global Standard on Expectations of Third Parties and Code of Ethics. In 2023, we conducted 47 audits (2022: 42) on high-risk commercial suppliers (external manufacturing partners) to ensure appropriate practices and controls. Of these, 50% fully met our expectations while 45% had improvement plans for minor instances of non-compliance. There were two audits indicating a high risk to AstraZeneca and action has been taken to mitigate these supply and/or reputational risks. We also use EcoVadis scores to assess and improve supplier sustainability performance. Our Sustainable Procurement Programme embeds responsible sourcing practices and promotes ethical behaviour, aiming to achieve 100% ethical spend with suppliers who share our Values. This fosters their progress on sustainability, enables us to innovate together and accelerates supplier diversity. Our Supplier Diversity Programme maximises opportunities for small and diverse businesses to be part of our value chain and supports their growth. In 2023, we reached our ambition to have active supplier diversity programmes in 10 countries outside the US by 2025, with Switzerland, Ireland and Canada joining Brazil, South Africa, the UK, Australia, New Zealand, Poland and Sweden. Global manufacturing capability Our principal tablet and capsule formulation and packing sites are in the UK, Sweden, China, Puerto Rico and the US, with local supply sites in Egypt, India, Japan and Russia, and regional supply sites in Brazil, Indonesia, France and Mexico. We also have major formulation sites for the global supply of parenteral and/or inhalation products in the US, Sweden, France, Australia and the UK. Most of the manufacture of active pharmaceutical ingredients (APIs) is delivered through the efficient use of external sourcing that is complemented by internal capabilities. For biologics, our principal commercial manufacturing facilities are in the US, Sweden, the UK and the Netherlands. Our network contains capabilities in process development, drug substance, drug product manufacturing and distribution, including global supply of mAbs and influenza vaccines. In January 2023, we finalised the sale of our West Chester site in Ohio, US, to National Resilience, Inc. This enabled the continued supply of AstraZeneca medicines produced at the site to patients, as well as continued employment for more than 500 people working at the site. We continue to pursue growth opportunities in China. In March 2023, we announced plans for a new facility in Qingdao to manufacture pressurised metered-dose inhalers (pMDIs) for respiratory products. In May 2023, AstraZeneca leased a facility in Rockville, Maryland, US. This facility will be fitted out for cell therapy manufacture to support clinical and commercial supply. In October 2023, we announced our intent to exit our supply site in Bangalore, India. Alexion has internal manufacturing facilities and also works with third-party contract manufacturers to supply clinical and commercial quantities of our products and product candidates. Our internal manufacturing capability includes a fill/finish facility at our Athlone site and a packaging and labelling facility at our Dublin site. Our drug substance manufacturing capabilities are shared between Athlone and Dublin and we have a large-scale drug substance facility in Dublin. At the end of 2023, we employed 15,609 people at 27 Operations sites in 16 countries. Growth and Therapy Area Leadership 40 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Business Review continued |
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IT and IS resources Demonstrating what is possible when digital technology meets science. We are already realising the value of our investments in AI, machine learning and deep learning to transform the way we work and accelerate drug discovery. For example, our patent optimiser tool helps our chemists identify the best molecules faster to support patent protection for our scientific breakthroughs. Our scientists and AI engineers use these technologies when solving chemistry, biology, pathology and clinical business problems. Our investments in AI and new solutions also improve how we launch new medicines and help transform patient outcomes. We are deploying these technologies to enhance the healthcare provider experience, expand our patient assistance programmes and improve how patients navigate the health ecosystem to manage their care. For example, our Rare Disease therapy area uses data and AI to identify patients, drive early diagnoses and accelerate their treatment in areas of high unmet medical need. We have created a robust, in-house programme for generative AI, identifying eight architecture patterns that cover use cases across AstraZeneca. This framework, which will be rolled out in 2024, ensures we are addressing the ethical, data privacy, legal and procurement requirements needed to fully leverage this new technology in a responsible way. In Operations, we continue to automate our manufacturing facilities to drive productivity improvement through optimising material and information flow, increasing process yields and driving right first time quality. For example, one of our global ‘digital lighthouse’ sites in Wuxi, China has already achieved top decile performance in quality, speed and performance through the use of an integrated Lean Digital approach. We ensure robust governance via the enterprise data office, which empowers the enterprise data council to strengthen the Group’s data governance. This approach ensures that our data policies and standards are streamlined, clear and effective. Our ongoing commitment to training helps our teams take full advantage of fast-developing new technologies to deliver innovation at pace across the organisation. This includes partnering with our HR and Learning & Development teams to upskill the entire organisation to help maximise the benefits of generative AI. We also invest in talent at our Global Technology Innovation Centres in Guadalajara, Mexico and Chennai, India as we prepare to scale our business for future growth. For information on how we manage cybersecurity risks, see Risk Overview from page 54. Accelerating the delivery of enhanced value in Global Operations Innovative technology platforms will transform the way new medicines are developed, manufactured and launched. Integrating digital solutions, data science and AI with continuous manufacturing platforms will enable shorter lead times, increased productivity and a reduced environmental impact. Business Review / Growth and Therapy Area Leadership AstraZeneca Annual Report & Form 20-F Information 2023 41 Strategic Report Corporate Governance Financial Statements Additional Information |
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Business Review continued Growth and Therapy Area Leadership Business development Our Business development teams pursue opportunities to access the best science and stimulate innovation. Business development is an essential part of our strategy and portfolio prioritisation process, contributing to accelerating delivery of new medicines targeting unmet medical need. In business development we assess cutting-edge technologies that can help enhance the quality, effectiveness and productivity of our research and translational capabilities across our key therapy areas. Our wide array of partnerships also includes key innovations across precision medicine and genomics and digital technologies, to deliver medicines to patients more efficiently. We currently have more than 1,000 ongoing collaborations worldwide and completed more than 20 major, or strategically important, business development transactions in 2023, some of which are summarised below. In 2023, new deals included: > The proposed acquisition of clinical-stage biopharmaceutical company Icosavax including their lead vaccine candidate, IVX-A12. This is a potential first-in-class, Phase III-ready, combination protein vaccine that targets both RSV and hMPV, two leading causes of severe respiratory infection and hospitalisation. The acquisition will build on AstraZeneca’s expertise in RSV, strengthening our Vaccines & Immune Therapies late-stage pipeline. AstraZeneca will acquire all of Icosavax’s outstanding shares for a price of $15.00 per share in cash at closing, plus a non-tradeable contingent value right for up to $5.00 per share in cash, payable upon achievement of a specified regulatory milestone and a sales milestone for up to a total consideration of $1.1 billion, if successful. The transaction is subject to the satisfaction of the conditions in the merger agreement and is expected to close in the first quarter of 2024. > A worldwide licensing transaction (excluding China) with Eccogene to develop and commercialise AZD5004, a Phase I oral once-daily GLP-1RA for the treatment of obesity, type-2 diabetes and other cardiometabolic conditions. In China, Eccogene has the right to co-develop and co-commercialise alongside AstraZeneca. Eccogene received an upfront payment of $185 million and is eligible to receive another $1.825 billion in future development and commercial milestones and tiered royalties. > A collaboration and proposed equity investment agreement with Cellectis, a clinical-stage biotechnology company, to leverage the Cellectis proprietary gene-editing technologies and manufacturing capabilities, to accelerate the development of next-generation therapeutics in areas of high unmet medical need. Cellectis received an initial upfront payment of $25 million and an additional equity investment of $80 million, at $5.00 per share, representing approximately 22% in Cellectis. A further $140 million equity investment, at $5.00 per share, is anticipated to close in early 2024, at which time AstraZeneca will hold a total equity stake of approximately 44% in Cellectis. > A global collaboration, option and licence agreement with Quell Therapeutics to develop multiple engineered Treg cell therapies that have the potential to be curative in type-1 diabetes and inflammatory bowel disease indications. Quell received an upfront payment of $85 million from AstraZeneca, which comprises a predominant cash payment and an equity investment. Quell is also eligible to receive over $2 billion for further development and commercialisation milestones, if successful, plus tiered royalties. In addition, Quell retains an option to co-develop Treg cell therapies from the type-1 diabetes programme with AstraZeneca in the US. > AstraZeneca purchasing and licensing assets of Pfizer’s early-stage rare disease gene therapy portfolio for a total consideration of up to $1 billion, plus tiered royalties on sales. The transaction will help advance next-generation genomic medicines with the addition of complementary pipeline assets and innovative technologies. This includes several novel adeno-associated virus capsids effective for delivering therapeutic gene cargos for gene therapy and gene editing. > A global exclusive licence agreement with KYM Biosciences for a Phase I ADC targeting Claudin 18.2, a positive therapeutic target in gastric cancer. KYM Biosciences received an upfront payment of $63 million and is eligible to receive additional development and sales-related milestone payments of up to $1.1 billion and tiered royalties. > The proposed acquisition of Gracell Biotechnologies Inc., a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases. The acquisition will further AstraZeneca’s cell therapy ambition and includes the clinical-stage autologous BCMA/CD19 CAR-T therapy targeting haematologic malignancies and autoimmune diseases and a proprietary cell therapy manufacturing platform. AstraZeneca will acquire all of Gracell’s fully diluted share capital through a merger for a price of $2.00 per ordinary share in cash at closing (equivalent to $10.00 per ADS of Gracell) plus a non-tradable contingent value right of $0.30 per ordinary share (equivalent to $1.50 per ADS of Gracell) in cash payable upon achievement of a specified regulatory milestone, representing a combined transaction value of approximately $1.2 billion. The transaction is expected to close in the first quarter of 2024. 42 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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-67.6% -58.7% -58.0% 2023 2022 2021 -67.6% Ambition Zero Carbon (Scope 1 and 2)1 2023 2022 2021 66.4m 44.6m 31.7m 66.4m People reached by our access to healthcare programmes3 2023 2022 2021 83% 83% 83% 83% % Speak up culture2 Business Review / People and Sustainability 2023 2022 2021 76% 77% 78% 76% Performing as an enterprise team1 88% Building a culture of lifelong learning and development2 88% 89% 88% 2023 2022 2021 50.1% Being champions of inclusion and diversity3 50.1% 49.5% 48.1% 2023 2022 2021 People and Sustainability Our performance in 2023 BV > Fully integrated Alexion employees. > Hired 25,660 employees (7,727 internal and 17,933 external). > 5,290 of these hires were a direct result of our employee referral scheme. > 4,401 employees attended a development programme (an increase in participation of 9% since 2022). > 50.1% of our senior middle management roles are filled by women. > Announced three ground-breaking renewable energy initiatives. > Reached 66.4 million people through our flagship access to healthcare programmes. > Published 2023 Partnership for Health System Sustainability and Resilience (PHSSR) Summary Report and expanded the programme in Asia-Pacific. > Reduced Scope 1 and 2 GHG emissions by 67.6% from 2015 baseline year. > Raised AZ Forest commitment to 200 million trees planted and stewarded by 2030 (from 50 million by 2025). Summary and performance indicators Our success depends on recruiting, retaining and developing talented people while operating in a responsible and sustainable way. Performance indicators BV People – Contribution to the enterprise This priority is built on three pillars: performing as an enterprise team, commitment to lifelong learning and development, and being champions of inclusion and diversity. Performance indicators BV Sustainability – Contribution to society We are tackling some of the biggest issues of our time, from climate change to access to healthcare and disease prevention. 1 Reduction of Scope 1 and 2 GHG emissions from 2015 baseline year. The data for 2021 and 2022 has been restated due to a site divestment and change in methodology. 3 Cumulative data including current and historical programmes: Healthy Heart Africa, Young Health Programme, Healthy Lung and Phakamisa. 2 Based on internal survey which asked all AstraZeneca employees if they felt comfortable to speak up/speak my mind and express my opinion at work. For more information, see People from page 44 and Sustainability from page 46. 1 Source: November Pulse full census survey for each year, based on the percentage of favourable responses to the statement ‘Based on my experience, I believe there is effective collaboration between teams across AstraZeneca’. 2 Source: November Pulse full census survey for each year, based on the percentage of favourable responses to the statement ‘In the last 12 months, I have improved my existing skills, or learned new skills, or had a development opportunity’. 3 Female representation in senior middle management roles and above (F+, the most senior 16% of the employee population). AstraZeneca Annual Report & Form 20-F Information 2023 43 Strategic Report Corporate Governance Financial Statements Additional Information |
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An essential element of our performance development approach is the provision of continuous recognition. In 2023, 535,979 rewards were distributed to 87% of employees through our recognition platform. Notably, 24% of these awards were cross-functional, highlighting the collaborative and cohesive nature of our organisation. Listening to our workforce Listening to our workforce is important in ensuring AstraZeneca continues to be a great place to work and we encourage employees to speak their minds. In 2023, feedback mechanisms included onboarding surveys, exit interviews and our global employee engagement survey. The results of our engagement survey are shared with the Board of Directors, Senior Executive Team (SET), line managers and employees to ensure full transparency. Key highlights: > 92% participation in global engagement survey. > 89% of employees stated they believe strongly in AstraZeneca’s future direction and key priorities. > 89% of employees stated they had at least one development discussion with their manager. > In exit interviews, more than 92% of employees who left said they would consider working at AstraZeneca again. > We received an average rating of 4.6 out of five from successful hires in our Candidate Experience survey. Advancing a culture of lifelong learning and development Central to our success is ensuring our employees, managers and teams have the potential to develop and grow. We develop capabilities through targeted and inclusive development programmes, from early talent Performing as an enterprise team Building diverse talent and critical capabilities In 2023, we successfully completed the integration of Alexion employees into AstraZeneca by: > Migrating 4,900 employees from Alexion to AstraZeneca. > Transitioning more than 100 employees from Alexion to AstraZeneca as a result of portfolio realignments. > Launching more than 200 new learning pathways on Degreed, our training platform. > Giving Alexion employees access to our CatAlyZe recognition platform – with 30,000 awards issued. > Holding more than 200 ‘Go-live’ workshops with HR in support of employees and managers. > Aligning Alexion employees to AstraZeneca employment benefits and policies in 20 countries. Creating a culture of high performance Since the removal of performance ratings in 2021, our primary focus has shifted towards coaching, development and the contributions of our employees. To aid managers in developing their teams, we deliver 80 performance development workshops each year. So far these have been attended by over 14,000 line managers. The effectiveness of our performance approach can be seen in the completion rate of end-of-year insights. In our 2023 performance development cycle, 96% of employees and 97% of managers successfully completed their year-end insights promoting accountability and goal alignment, and enabling fair and objective evaluation. to enterprise leaders. Our digital learning portal supports a continuous learning mindset that drives a high-performing and innovative organisation. Key 2023 highlights demonstrating our progress: > Invested $33.7 million in the upskilling of our employees, an average spend of $376 per employee. > 2,040,956 total learning hours, an average of 17.7 hours per employee. > 69% of employees accessed our global learning platform. > 4,401 attendees across our development experiences (up 9% since 2022). > 88% of employees believe they have improved their existing skills, learned new skills or had a development opportunity. Our development programmes build capabilities for the future, helping us to unlock potential, drive innovation and foster an inclusive culture, building diverse future leaders. Of our 2023 development experience attendees, 21% were identified as succession candidates for at least one position and 73% of our programme participants are women. The resignation rate for employees who went through a development programme is 8.3%, compared to 10% for AstraZeneca overall. Our programmes are designed to support our People strategy. During 2023, AstraZeneca received the prestigious International Coaching Federation Distinguished Organisation Impact Award, together with awards for our early talent and diversity programmes. People Attracting, retaining and developing talented individuals is key to our growth and success. We achieve this by cultivating a great place to work that values and rewards innovation, entrepreneurship and outstanding performance. Unlocking the potential of our people Our award-winning coaching strategy helps employees learn, adapt and grow. People and Sustainability Business Review continued 44 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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everyone feels valued and respected because of their individual abilities and perspectives. In 2023, our I&D efforts earned recognition externally. We were featured in: > Forbes World’s Top Companies for Women > Forbes World’s Best Employers > Financial Times, Diversity Leaders > Diversity Inc. Top 50 Companies for Diversity (US) > TIME World’s Best Companies. Human rights BV Our human rights principles support the basic rights of all people, such as the right to health, freedom from slavery, and privacy. Our Code of Ethics, Human Rights Statement and Expectations of Third Parties commit us to respecting and promoting international human rights, both within our own operations but also our wider spheres of influence. This includes working only with third parties who share our approach. To that end, we integrate human rights considerations into our processes and practices. We are also committed to ensuring that there is no modern slavery or human trafficking in our value chains, or any part of our business. Our human rights policies are designed to ensure we consider the impact of our operations including our interactions with third parties on human rights. The output of our work to mitigate human rights risks is detailed in our Modern Slavery Statement which is published annually. We provide assurance annually to the Audit Committee. Employee relations BV Our Employee Relations function takes a global approach to employment principles and standards, local laws and good practice. Our ambition is to build a positive and safe working environment for employees through global policies and processes. To achieve this, our Employee Relations function works in partnership with Legal, Compliance, HR and Employee Representative groups, such as the European Consultation Committee, works councils and unions. According to our biennial Human Rights survey, the most recent of which was carried out in 2022, 45% of our countries have a relationship with trade unions. Champions of inclusion and diversity Our global commitment to inclusion and diversity (I&D) is woven into everything we do, and is reflected in our Values and the behaviours that underpin them. Women comprise 53.9% (approximately 47,800) of our global workforce. At the end of 2023, there were six women on our Board (46.2% of the total). Following the retirement of Katarina Ageborg in January 2023 and the appointment of Sharon Barr as Executive Vice-President, BioPharmaceuticals R&D in August 2023, five out of 12 SET members (41.7%) were women at the end of the year. Mene Pangalos will be retiring in early 2024. Our employees represent a diverse range of backgrounds, coming from 179 countries. In 2023, to promote inclusion and diversity, we have established the Global Inclusion and Diversity Ambassador Group, which is led by senior leaders and sponsored by our CEO. This group reflects the diversity of our global workforce and organisational structure. They are responsible for collaborating with local leaders to customise approaches that address local needs and drive progress towards our global inclusion and diversity commitments. Our Board of Directors and the SET conduct biannual and quarterly reviews, respectively, of our workforce composition, covering gender, ethnicity and age representation. In the US, where we have more comprehensive data available, 36.7% of our workforce identify as an ethnic minority (2022: 35.7%). In 2023, we rolled out pay equity training to all line managers of US-based employees to ensure equitable reward and compensation. We are committed to hiring and promoting talent ethically and in compliance with applicable laws. Our Code of Ethics (the Code) and its supporting Standards are designed to help protect against unlawful discrimination on any grounds, including disability. The Code covers recruitment and selection, performance management, career development and promotion, transfer, training (including, if needed, for people who have become disabled), and reward. AstraZeneca embraces the cognitive differences of neurodivergent employees and supports employees with both seen and unseen disabilities in line with their country-specific laws and regulations. Where risk assessments can be performed, we will consider accommodating adjustments to the working environment that support an inclusive and safe workplace. Our Global Standard for Inclusion and Diversity sets out how we foster an inclusive and diverse workforce where Of those countries that do not have a relationship with trade unions, 95% of them have established arrangements to engage similarly with their workforce. Workforce safety and health BV We are committed to providing a safe and healthy working environment for our employees and partners. Our Global Safety, Health and Environment (SHE) Standard describes our commitment to, management of, and accountability for SHE. We set and monitor our safety and health targets to support our workforce and aim to achieve the highest performance standards. Our work-related injury rate reduced by 59.6% from the 2015 baseline. AstraZeneca responded to an increasing collision trend in 2022 by developing a safe driving campaign and training endorsed by the Commercial SHE Executive Committee. This campaign continued into 2023 and has shown a positive impact on collisions per million kilometres (CPMK). In 2023, the CPMK was 1.96, exceeding the 2.5 target for the year and on course to meet or exceed the target for 2025 of 1.90. For more information on our standards and Code of Ethics and for our full statement detailing how we work to mitigate the risks of modern slavery, see our website, www.astrazeneca.com/ sustainability/resources.html. Business Review / People and Sustainability AstraZeneca Annual Report & Form 20-F Information 2023 45 Strategic Report Corporate Governance Financial Statements Additional Information |
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People and Sustainability Access to healthcare Environmental protection Ethics and transparency Equitable access Affordability and pricing Health system resilience Ambition Zero Carbon Product sustainability Natural resources Ethical business culture Inclusion and diversity Workforce safety and health Our approach to sustainability Our Purpose to push the boundaries of science to deliver life-changing medicines is underpinned by our commitment to contribute sustainably to people, society and the planet. As a global business, we are playing our part by operating ethically and responsibly, and helping tackle the biggest challenges of our time, including climate change, biodiversity loss and global health equity. These challenges are interdependent and require collaboration to be successfully addressed, implementing a variety of approaches across a network of relationships. By working together to find science-based solutions, we believe we can drive real change and build a better future. Governance Our sustainability strategy is developed by the SET, which reviews our sustainability scorecard quarterly, and is approved by the Board. Our Board Sustainability Committee monitors the execution of the sustainability strategy, overseeing the communication of our activities with stakeholders, and providing input to the Board and other Board Committees as required. Overview We seek to create value beyond the impact of our medicines by embedding sustainability into everything we do – from the lab to the patient – and by supporting health system resilience to make sustainable healthcare available to all. During 2023, we were recognised for our efforts across all our sustainability priorities, including: > AstraZeneca received a rating of AA (on a scale of AAA-CCC) in the MSCI ESG Ratings assessment. > Included in Dow Jones Sustainability Index Top 20% of 2,500 of the world’s largest companies and in Europe Index. > Listed in Financial Times European Climate Leaders for the third consecutive year. > Included in Forbes World’s Top Companies for Women. Benchmarking and assurance We contribute to key global environmental, social and governance (ESG) performance evaluations, recognising the value of independent third-party assessment and insights. Our performance is also assessed independently based on the information and data we make publicly available. Bureau Veritas has provided limited independent assurance for the sustainability information contained within this Annual Report and Form 20-F. Assurance is in accordance with the International Standard on Assurance Engagements (ISAE) 3000 (Revised) and ISAE 3410 Assurance Engagements on Greenhouse Gas (GHG) Statements. Sustainability strategy We assess the relevance of our material focus areas through continuous dialogue with our stakeholders and horizon-scanning for developments. Since 2021, our nine priority focus areas have been grouped under three interconnected strategic priority pillars: Sustainability Sustainability at AstraZeneca means harnessing the power of science and innovation, and our global reach, to build a healthy future for people, society and the planet. BV Driving emissions reductions with clean heat and renewable energy The research, development and production of medicines is an energy intensive process. We are decarbonising our operations as we transition to net zero: in the UK and in the US, we will use renewable natural gas, or biomethane, to supply clean heat to our sites. For more information, see: Our Sustainability Report on www.astrazeneca.com/ sustainability/resources.html. The letter of assurance in the Annual Sustainability Report section on www.astrazeneca.com/ sustainability/resources.html. Board Sustainability Committee Report on page 93. Sustainability supplementary information on page 230. Business Review continued 46 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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As we expand the geographies where our rare disease medicines are available, we continue to build relationships with patient communities early in our development programmes to better understand their needs. We focus on: increasing clinical trial diversity; developing improved data collection processes to enhance our understanding of how rare diseases affect specific patient populations; improving access to diagnostic tools; and supporting efforts to improve the experience of those participating in our clinical trials. We also supply medicines for rare diseases through patient support and access programmes. Improving access to digital solutions Through our A.Catalyst Network innovative partnerships, we are harnessing the latest technologies to improve patient outcomes, make healthcare more accessible and personalised, and drive efficiencies in health systems. As participants in EDISON Alliance’s One Billion Lives Challenge, we aim to screen five million patients for lung cancer risk by 2025, using AI-based technology in collaboration with Qure.ai. Affordability and pricing We are committed to addressing barriers to access and affordability. Industry, policymakers and payers need to work together to identify solutions. Through collaborations, partnerships and stakeholder coalitions, we are working to ensure essential and innovative medicines become more widely available. Health system resilience Sustainable healthcare for all requires stronger health systems to deliver an infrastructure designed to be resilient, inclusive and responsive to the needs of the population it serves. We are investing in ground-breaking global collaborations, driving multisectoral policy and action, empowering local partnerships and fast-tracking innovation to expand access to higher quality healthcare. Partnership for Health System Sustainability and Resilience (PHSSR) The PHSSR is a non-profit, multisector, global collaboration with a unified goal of building more sustainable and resilient health systems, active in more than 30 countries. PHSSR has commissioned over 20 research reports to date, providing independent, evidence-based recommendations to strengthen health systems and facilitate cross-border best-practice sharing, working with national experts with first-hand experience. In 2023, PHSSR published its second Summary Report with insights from 18 countries, and launched research on seven new Asia-Pacific countries. PHSSR also established an EU expert advisory group, to support EU policymakers in improving policies on prevention and early detection of NCDs. By fostering joint learning and action through high-level stakeholder engagement at over Access to healthcare BV We want to secure a future where all people have access to affordable, sustainable and innovative healthcare, throughout the patient care pathway, from prevention, early detection and diagnosis, to the effective treatment of disease. We are working to remove barriers, deliver innovative medicines and strengthen health system infrastructure and resilience through global and local partnerships, across all our focus areas. Achievements in 2023 > We reached more than 66 million people (cumulatively) through access to healthcare programmes. > Healthy Heart Africa trained more than 11,300 healthcare workers (cumulatively) and conducted more than 47 million screenings (cumulatively) for elevated blood pressure. > Young Health Programme directly reached more than 15 million young people (cumulatively) and trained over 580,000 as Peer Educators since launch in 2010 in more than 40 countries. > We reached more than 13 million people (cumulatively) through our patient access programmes, enabling sustainable access to AstraZeneca medicines in around 25 countries, most of which were low- and middle-income countries. Equitable access Your health should not be determined by who you are, where you live or where you were born. We are working to remove barriers to healthcare and give everyone the chance to be as healthy as possible. Diversity in clinical trials We are committed to designing clinical programmes with equity at the forefront, from idea inception to patient care. Our approach is patient-centric, data-driven and science-led. We are improving the diversity of clinical trial participants with strong data foundations, tools and standards for aligning and tracking progress, and external partnerships. We work with industry groups, regulatory agencies, and local community groups to shape clinical trial diversity policies for the future, while delivering for patients today. Rare diseases More than 10,000 rare diseases are estimated to exist today, but fewer than 10% have approved treatment options. Rare disease community members face many unique challenges in pursuing equitable access to healthcare, such as significant delays in diagnosis, greater chances of hospitalisation from preventable conditions, scheduling and travelling to appointments, and accessing available treatments. We believe people with rare diseases deserve the same attention and investment to find and access therapies as anyone else. 40 global, regional and national platforms, the PHSSR catalysed efforts to strengthen health systems around the world. Healthy Heart Africa programme Our Healthy Heart Africa programme is committed to reducing hypertension and the burden of cardiovascular disease, aiming to reach 10 million people with elevated blood pressure across Africa by 2025. We work with local and global partners to raise awareness and offer training, screening and reduced cost treatment, where applicable. In 2023, the programme launched in eight of 10 planned grant countries, in addition to the existing nine countries of operation. Young Health Programme The multi award-winning Young Health Programme (YHP) aims to empower young people to make more informed choices about their health and catalyse a global, youth-led advocacy movement, supported by community programmes and research. It helps to develop young leaders and is focused on vulnerable and under-resourced communities in 40 countries. Through partnerships with more than 60 non-profit partners around the world including UNICEF, the YHP promotes health literacy and policy action. In 2023, the YHP won the Better Society Award for Partnership with an International Charity together with UNICEF. Community investment Community investment at AstraZeneca is built upon the principles of equity, transparency and partnership, working together to build healthy and resilient communities. In 2023, we contributed $115.4 million in financial and non-financial donations, (including product donations), to more than 810 non-profit partners across 76 countries. We also donated $4.7 billion (2022: $3.1 billion) of medicines through patient assistance programmes around the world, the largest of which is our AZ&Me Prescription Savings Program in the US. Product donation programmes In 2023, we gave $7.5 million (2022: $12.1 million) in product donations for disaster, humanitarian relief and public health need. We are committed to working with all health system stakeholders to enable the supply of medicine to patients and to support the resilience and recovery of healthcare facilities in vulnerable communities. For more information, see: Pricing and value of our medicines on page 39. Rare Disease from page 28. Qure.ai case study on page 19. AstraZeneca Annual Report & Form 20-F Information 2023 47 Strategic Report Corporate Governance Financial Statements Additional Information Business Review / People and Sustainability |
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Longer-term targets: > 50% reduction in total Scope 3 GHG emissions by 2030 and 90% reduction by 2045, from 2019 baseline. > Carbon negative for all residual emissions from 2030 and science-based net zero by 2045. > Transition to next-generation respiratory inhalers with near-zero climate impact propellant across our portfolio by 2030. > Plant and maintain 200 million trees by 2030, through our global AZ Forest initiative. Our goal of becoming carbon negative across our value chain from 2030 recognises that total emissions from value chain partners are significantly larger than from our own direct operations. We are embedding net-zero assessments into our existing and future product portfolios, engaging our suppliers to reduce their direct emissions through to 2030 and identifying carbon removal options. Product sustainability People and the planet will benefit from those medicines that have the smallest possible environmental impact, yet maintain the highest efficacy and safety standards. As technologies and healthcare systems evolve, so should solutions to reduce the use of energy, water and material, as well as waste and pollution generated from designing, manufacturing and delivering medicines to patients. We are using a data-driven approach through our Life Cycle Assessment (LCA) and Product Sustainability Index programmes to address the largest contributor to our Scope 3 emissions: our product value chains. In 2023, we continued to focus on the next-generation propellant transition for pMDI products in our respiratory portfolio. The new propellant HFO-1234ze(E) has up to 99.9% lower GWP than propellants currently used in respiratory medicines. As essential, life-saving medicines for millions of respiratory patients globally, they are strategically important to our business and a key product-related element of Ambition Zero Carbon. In 2023, project milestones achieved included further Phase III investment decisions, a harmonised, global development programme, readouts of pivotal studies and initiation of key registration studies. As part of our commitment to drive thought leadership and innovation to manage pharmaceuticals in the environment, we lead the Innovative Health Initiative PREMIER project, a partnership between the European Commission and the EFPIA. We are developing tools to identify potential environmental risks of APIs and make data more accessible to all stakeholders. In 2023, PREMIER published an evidence-led prioritisation of environmental data generation, aiming to reduce reliance on fish studies. Natural resources The conservation and sustainable use of natural resources and the protection and restoration of ecosystems are vital for a healthy future and to tackle the environmental drivers of disease. We are investing in nature to benefit planetary and societal health, while working towards sustainable resource use, water security and halting and reversing biodiversity loss. Our targets aim to decouple water use and waste generation from business growth and to minimise environmental impacts from our supply chain and operations, supported by efficiency projects, collaboration with suppliers on responsible sourcing, designing out waste and pollution, and landscape restoration targets via AZ Forest. Circular economy Adopting circular business approaches and implementing efficient processes to develop and produce our medicines are key to reducing natural resources used in our value chains. We are leveraging our experience with Lean manufacturing and embedding best practices, working with organisations such as My Green Lab. In 2023, we introduced a new internal Site Waste Circularity Rate metric to drive improvements through increased recycling and the external reuse or repurposing of waste materials across all our sites. Water stewardship We continue to work with key stakeholders, including our ongoing collaboration with the World Wide Fund for Nature Sweden. Starting in 2024, we will invest $5 million per year to fund nature restoration and water stewardship projects in the communities where we operate. AZ Forest In 2023, we announced an increase in our investment to $400 million in our global AZ Forest programme, to plant 200 million trees by 2030 and ensure their long-term survival. This includes new or expanded projects in Brazil, India, Vietnam, Ghana, Rwanda and Kenya, which will contribute to our climate action, promote the restoration of biodiversity and natural habitats, and build community resilience. The programme is expected to restore more than 100,000 hectares worldwide, positively impacting an estimated 80,000 livelihoods and local communities. We are led by guiding principles that provide a baseline for project design and a consistent approach that follows the science. We do not purchase land for reforestation or own the trees, but have the rights to carbon certificates generated by some projects. In 2023, we planted over nine million trees using locally-appropriate species. Sustainability continued BV Environmental protection BV A healthy environment is critical for human health and health system resilience, already impacted by climate change and the degradation of ecosystems. Science-led climate action and investments in nature and biodiversity are vital to improving health outcomes and proactively managing our environmental impact. Through our Natural Resource Efficiency Fund, we have invested approximately $175 million in environmental efficiency innovations since 2015. This, together with other central capital investments, has seen a further $36.6 million spent in 2023, including 72 new projects. Achievements in 2023 > 67.6% reduction in Scope 1 and 2 GHG emissions since 2015. > 17.5% reduction in energy consumption since 2015. > 19.9 million trees planted by AZ Forest since 2020. > 19.5% reduction in water usage and 13.2% reduction in our waste since 2015. > 99% safe API discharges for AstraZeneca sites and 94% safe API discharges for globally managed first-tier supplier sites. > 97.6% of paper-based product packaging materials used in 2022 (data collated in 2023) confirmed as supplied from sustainable sources. Ambition Zero Carbon Approximately 5% of global GHG emissions come from the healthcare sector. We are accelerating the delivery of net-zero healthcare and our own progress towards net zero, as one of the first companies to have our Scope 1, 2 and 3 targets verified under the Science-Based Targets initiative Net-Zero Corporate Standard. Near-term targets: > 98% absolute reduction in Scope 1 and 2 GHG emissions by 2026 from 2015 baseline, maximising transition to electric vehicles in our road fleet (EV100) by end of 2025 and using 100% renewable energy (RE100) for electricity and heat by end of 2025. > Reduce energy consumption by 10% and double energy productivity (EP100) from 2015 to 2025. > Launch first next-generation respiratory inhalers with near-zero climate impact propellant from 2025. > 95% of our suppliers by spend covering purchased goods and services and capital goods, and 50% of our suppliers by spend covering upstream transportation and distribution and business travel, will have science-based targets (SBTs) by 2025. People and Sustainability Business Review continued 48 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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The Code includes high-level Global Policies complemented by Global Standards. We also have additional global, local and functional requirements to support employees in their daily work. The Code asks employees to report possible violations and provides information on how to do so, including via the AZ Ethics helpline or website. AZ Ethics is also available to third parties. Reports can be made anonymously where desired and permitted by local law. Anyone who raises a potential breach in good faith is fully supported by management; retaliation is not tolerated. The majority of cases come to our attention through self-reporting to line managers or local Human Resources, Legal or Compliance. In 2023, 470 reports of alleged compliance breaches or other ethical concerns were made through AZ Ethics, including anonymous reports that could be considered whistleblowing (2022: 490). A Finance Code complements the Code and applies to the CFO, the Group’s principal accounting officers (including key finance staff in all overseas subsidiaries) and all managers in the Finance function. This reinforces the importance of the integrity of the Group’s Financial Statements, the reliability of the accounting records on which they are based, and the robustness of the relevant controls and processes. Ethics and transparency BV We seek to create positive societal impact and embed ethical behaviour in all our business activities, markets and value chain. We promote ethical, transparent and inclusive policies internally as well as with our partners and suppliers. It is important that we create value beyond the impact our medicines have on patients. We need to ensure that we retain and increase trust across all our stakeholder groups in order to continue delivering life-changing medicines to patients. Achievements in 2023 > 50.1% of senior middle management roles are held by women. > We have 10 countries with supplier diversity programmes outside the US. > 83% of employee survey respondents feel they can speak their mind at work. Code of Ethics We are committed to high ethical standards. Our Code of Ethics (the Code) embodies our Values, expected behaviours, principles and policies. It applies to all Executive and Non-Executive Directors, officers, employees and contract staff of our worldwide Group. The Code empowers employees to make decisions in the best interests of the Group, the communities in which we work and the people we serve. It focuses on why our commitments matter and is at the core of our Compliance Programme. It has been translated into approximately 40 languages and guides employees on how to make the best choices and act in a consistent, responsible way. Our mandatory training reminds employees of our commitments. In 2023, 100% of active employees completed annual training on the Code. Non-Financial and Sustainability Information Statement Under sections 414CA and 414CB of the Companies Act 2006, as introduced by the Companies, Partnerships and Groups (Accounts and Non-Financial Reporting) Regulations 2016, and amended by The Companies (Strategic Report) (Climate-related Financial Disclosure) Regulations 2022, AstraZeneca is required to include, in its Strategic Report, a non‑financial and sustainability statement containing certain information. As required by these sections, the Strategic Report contains our Climate-related Financial Disclosures (as defined in section 414CB(2A) – see pages 51 to 53), as well as information on the following matters, which include references to our relevant policies, due diligence processes and information on how we are performing against various measures in these areas: > Anti-bribery and anti-corruption, see page 39 > Code of Ethics, see page 49 > Access to healthcare, see page 47 > Environmental protection, see page 48 > People, see page 44 > Human rights, see page 45. In relation to the areas listed above, information on the Group’s Principal Risks is included in Risk Overview (see from page 54) and information on the non‑financial key performance indicators relevant to our business is included in Key Performance Indicators (see from page 12). A description of our business model is contained in Business Model and Life-cycle of a medicine (see from page 10). For more information, see: Our Sustainability Report on www.astrazeneca.com/ sustainability/resources.html. Our Code, Global Policies and Position Statements on our website, www.astrazeneca.com/ sustainability/resources.html. Champions of inclusion and diversity, and Workforce safety and health, on page 45. My Green Lab case study on page 37. Ethical use of AI Our Enterprise AI Governance team aims to ensure that AstraZeneca can maximise the benefits of AI technologies in a safe, responsible and ethical way. Business Review / People and Sustainability Strategic Report Corporate Governance Financial Statements Additional Information AstraZeneca Annual Report & Form 20-F Information 2023 49 |
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Assessment The EU Taxonomy (Regulation (EU) 2020/852) and associated Delegated Acts represent an evolving reporting framework. The EU Taxonomy (Taxonomy) is a classification system for sustainable economic activities. An economic activity is Taxonomy-eligible if it is described in the Taxonomy Delegated Acts. An economic activity is Taxonomy-aligned if it makes a substantial contribution to one or more of the specified environmental objectives, meets specified Do-No-Significant-Harm criteria, and is carried out in compliance with specified minimum social safeguards. In 2023, the EU adopted the new Environmental Delegated Act, which includes pharmaceutical activities. Information prepared under this disclosure is consistent with our Consolidated Financial Statements for the year ended 31 December 2023, and comparatives, prepared under the basis of preparation detailed in our Group Accounting Policies on page 152. Capital expenditure (Capex) was assessed for Taxonomy-eligibility on a project basis. Operating expenditures (Opex) were assessed for Taxonomy-eligibility based on the nature of expense. Taxonomy-alignment assessments were conducted on an activity level, based on our Global Standards and Policies. No activity was assessed as fully Taxonomy-aligned in 2023. Double-counting was avoided by reconciliation to underlying financial records. Interpretation of the EU Taxonomy is required and company-specific assumptions are required to fulfil the reporting requirements. Since no activity was assessed as fully Taxonomy-aligned, we have set out our required disclosures in a simplified format below as the prescribed table formats relating to alignment disclosures are not applicable. Revenue The Taxonomy-eligible Revenue KPI is defined as Taxonomy-eligible Revenue divided by Total Revenue, which corresponds to ‘Total Revenue’ in our Consolidated Statement of Comprehensive Income as detailed on page 148. The Group’s revenues are wholly derived from the business of pharmaceuticals, which we accordingly consider in total for Taxonomy-eligibility under the activity ‘Manufacture of medicinal products’. Consequently, our Taxonomy-eligible Revenue KPI for the year ended 31 December 2023 is 100% (2022: 0%). Last year, our business activity of pharmaceuticals was not covered by the EU Taxonomy. Capital expenditure The Taxonomy-eligible Capex KPI is defined as Taxonomy-eligible Capex divided by Total Capex. > Taxonomy-eligible Capex is capex related to assets or processes associated with Taxonomy-eligible activities. Purchase of intellectual property, marketing and distribution rights over medicinal products is considered in total for Taxonomy-eligibility under the activity ‘Manufacture of medicinal products’. > Total Capex corresponds to the total of the ‘Additions through business combinations’ and ‘Capital expenditure’ movement types as detailed in Note 7 – Property, plant and equipment (page 169), the total of the ‘Additions – separately acquired’ and ‘Additions through business combinations’ movement types as detailed in Note 8 – Leases Right-of-use assets (page 170), and the total of the ‘Additions – separately acquired’ and ‘Additions through business combinations’ movement types as detailed in Note 10 – Intangible assets (page 172). The Group’s Taxonomy-eligible Capex KPI for the year ended 31 December 2023 is 83% (2022: 14%). Operating expenditure The Taxonomy-eligible Opex KPI is defined as Taxonomy-eligible Opex divided by Taxonomy-defined Opex. > The Group’s Taxonomy-eligible Opex is expenses related to assets or processes associated with Taxonomy-eligible economic activities. R&D expenses are considered in total for Taxonomy-eligibility under the activity ‘Manufacture of medicinal products’. > The Group’s Taxonomy-defined Opex is the total of R&D expenses, and other direct non-capitalised costs that relate to building renovation measures, short-term leases, maintenance and repair, and any other direct expenditures incurred in the day-to-day servicing of assets of Property, plant and equipment. The Group’s Taxonomy-eligible Opex KPI for the year ended 31 December 2023 is 99% (2022: 2%). Taxonomy eligibility and alignment Revenue Capex Opex 2023 2022 2023 2022 2023 2022 $m % $m % $m % $m % $m % $m % Taxonomy-aligned activities No activities were assessed as Taxonomy-aligned Taxonomy-eligible but not Taxonomy-aligned 1.2 Manufacture of medicinal products 45,811 100 n/a n/a 65 n/a 96 n/a 6.5 Transport by motorbikes, passenger cars and light commercial vehicles 4 2 – – 7.1 Construction of new buildings 6 8 – – 7.2 Renovation of existing buildings 4,918 2 3,519 2 11,380 – 10,076 – 7.7 Acquisition and ownership of buildings 5 – 3 2 8.1 Data processing, hosting and related activities 1 1 – – 8.2 Computer programming, consultancy and related activities – 1 – – 50 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report EU Taxonomy Disclosure BV |
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Our commitment to climate change We support the Task Force on Climate-related Financial Disclosures (TCFD) framework. As such, we have made disclosures within the Annual Report consistent with the four TCFD recommendations, the 11 recommended disclosures and all sector guidance, and in compliance with the requirements of Listing Rule 9.8.6R(8) of the UK Financial Conduct Authority (FCA) and in compliance with sections 414CA and 414CB of the Companies Act 2006 and amended by The Companies (Strategic Report) (Climate-related Financial Disclosure) Regulations 2022. Pages 51 to 53 set out the required disclosures in more detail and explain where further information can be found – for example methodology and results – including documents outside this Annual Report. We have applied the TCFD framework since 2020, initially focusing on the most significant risks and opportunities, with plans to include medium- and low-risk areas indicated by section. All our business operations worldwide are in scope unless otherwise stated. To future-proof our business and build resilience to ensure long-term financial sustainability and the continued supply of medicines to patients, we have screened physical risks from the impacts of climate change across our operations and strategic suppliers. These risks are defined by the cost of interruption and strategic importance, and our assessment includes climate change-related hazards arising under three different scenarios by 2030, 2050 and 2100, including a worst-case scenario (SSP5-RCP 8.5). We prioritised screening results according to business criticality, to identify material sites for deep dive assessments during 2021 and 2023. We also continued to engage with strategic partners with a critical role in patient supply to understand their exposure to climate-related hazards and their resilience to climate change. For medicines, transition risks and opportunities are screened by using LCA and carbon intensity data. In 2023, we have continued to focus on pMDIs in our respiratory portfolio due to their relative high carbon intensity. We aim to launch our first next-generation pMDI from 2025 and complete the transition to a near-zero Global Warming Potential (GWP) propellant across our portfolio by 2030, as part of our Ambition Zero Carbon strategy to accelerate business decarbonisation while ensuring people can access essential medicines. Mitigation measures are often already in place to address climate-related risks and opportunities, including transition to a low-carbon economy and net-zero healthcare provision. Physical and transitional climate-related risks are included within a specific risk in the Group’s risk landscape ‘Failure to meet regulatory or ethical expectations on environmental impact, including climate change’. Climate risk summarised Risk or opportunity Time horizon Short/Mid/Long Potential impact How it is managed Physical risks Disruption to own and third-party supplier sites: > Increased extreme heat events and cooling needs impacting compliance with Good Manufacturing Practice. > Heavy rainfall causing local flooding and/or landslides. > High winds damaging structures. > Lack of a consistent high-quality water supply. Identified risks are embedded within planning of nature-based or technical mitigations, integrated into site master plans and local business continuity plans. Climate risks are mitigated through supply chain design and product-level business continuity management. Appropriate water management strategies are being established across our manufacturing sites and the broader supply chain. Transition risks and opportunities Some healthcare providers are transitioning to net-zero healthcare systems to meet their own climate targets, which may alter the demand for medicinal products based on their carbon footprint. SBTs and strategy for net-zero emissions by 2045, including transition to near-zero GWP propellant across our respiratory portfolio from 2025 to 2030. New EU Fluorinated-gas (F-gas) Regulation and per- and polyfluoroalkyl substances (PFAS) restriction proposal presented to the European Chemicals Agency (ECHA) and potential impact on our transition to next-generation, near-zero GWP propellant HFO-1234 ze(E). We believe the necessary safeguards and sufficient quota will remain available within the forthcoming EU F-gas Regulation to transition our pMDI portfolio safely to next-generation, near-zero GWP propellant by 2030. In response to the ECHA public consultation, we have recommended that HFO-1234 ze(E) should be excluded from the proposed universal ban to ensure patient access to essential life-saving pMDI medicines is maintained. Carbon pricing uncertainty over future environmental taxation and regulation. Delivery of the Ambition Zero Carbon strategy mitigates exposure to future value chain pricing and taxation. Supply/demand of renewable energy requires higher investment. Changes in geopolitics can lead to loss of access. Investment of approximately $175 million in our natural resource reduction programme since 2015, including $25.5 million in 2023, and collaborations with key partners to scale renewable energy sources and secure supply chain access. Change in raw material or sourcing costs, as well as costs related to the transition to low-carbon technologies. Ongoing engagement with strategic supply chain partners on their transition plans to a low-carbon economy and possible impacts on cost. Key Low risk Medium risk High risk Opportunity Time horizon for impact Short-term: 1-3 years Mid-term: 3-7 years Long-term: 7-25 years For more information, see: Our 2023 TCFD Statement on our website, www.astrazeneca.com/ annualreport2023. Our CDP response, based on 2023 performance on our approach to climate change, on www.cdp.net/en. Our Sustainability Report: which describes our overall approach and progress, on our website, www.astrazeneca.com/ sustainability/resources.html. The Risk Supplement on our website, www.astrazeneca.com/ annualreport2023. Our strategy and GHG emissions reduction targets and progress, from page 12, and on pages 43 and 48. AstraZeneca Annual Report & Form 20-F Information 2023 51 Strategic Report Corporate Governance Financial Statements Additional Information Task Force on Climate-related Financial Disclosures Summary Statement Task Force on Climate-related Financial Disclosures Summary Statement BV |
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TCFD framework and recommended disclosures AstraZeneca current status Links to more information on key developments Governance Describe the Board’s oversight of climate-related risks and opportunities. The Board Sustainability Committee monitors the execution of our sustainability strategy, including climate-related matters. The Board Audit Committee is responsible for overseeing sustainability-related disclosures that are linked to the Company’s Financial Statements. pages 2 to 3 pages 46, 93 and 96 page 6 Describe management’s role in assessing and managing climate-related risks and opportunities. Our CEO’s responsibilities to the Board include the development and performance of our climate strategy and related risks and opportunities. Our EVP, Global Operations, IT & Chief Sustainability Officer, is responsible for the overall sustainability strategy and its execution, including Ambition Zero Carbon and alignment of business priorities with climate risks and opportunities. The Ambition Zero Carbon Governance Group is accountable for the delivery of our Ambition Zero Carbon strategy. The TCFD Steering Group coordinates management of physical and transitional climate risks and opportunities. pages 2 to 3 page 46 pages 6 and 16 Strategy Describe the climate-related risks and opportunities the organisation has identified over the short, medium, and long term. Physical risks from climate change primarily relate to disruption or delays to manufacturing and/or distribution, including cold chain logistics, increased insurance premiums, reputational damage, and other resulting consequences – see table on page 51. Transition risks and opportunities are primarily regulatory and market changes, and/or pressure and ability to reduce product carbon footprints and decarbonise our value chain – see table on page 51. pages 5 to 10 pages 16 to 19 Describe the impact of climate-related risks and opportunities on the organisation’s businesses, strategy, and financial planning. Taking into account climate-related risks and opportunities, we are taking enterprise-wide action to reduce GHG emissions from our global operations and fleet by 98% by 2026 (from a 2015 baseline) with a $1 billion spend budgeted from 2020. We aim to halve our entire value chain footprint (Scope 3) by 2030, on a pathway to achieve a 90% reduction in emissions by 2045 (from a 2019 baseline). In 2023, we increased our investment in nature-based solutions to $400 million through AZ Forest, to mitigate our residual emissions and reach our net-zero SBTs to prepare for a low-carbon economy, and contribute to community and nature resilience with broader co-benefits. Our transition plan to net zero is disclosed in our Sustainability Report as a response to FCA requirement 2021/61 9.8.6F. pages 5 to 10 pages 16 to 21 Describe the resilience of the organisation’s strategy, taking into consideration different climate-related scenarios, including a 2°C or lower scenario. We build resilience by addressing the physical and transitional risks and opportunities across the value chain. We have used three different climate-related scenarios (RCP 2.6, 4.5 and 8.5). We are building resilience against a worst-case scenario (RCP 8.5) in our supply chain by investing in mitigation in at-risk sites, supply chain design, and inventory levels, to manage interruption risks. No material business impact from such short-term events is currently foreseen. Value chain decarbonisation, with net-zero targets aligned to a 1.5°C scenario, will secure low-carbon economy resilience and scale opportunities in progressive markets. pages 1, 4 and 6 Key TCFD Statement Annual Report Sustainability Report 52 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Task Force on Climate-related Financial Disclosures Summary Statement continued BV |
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TCFD framework and recommended disclosures AstraZeneca current status Links to more information on key developments Risk management Describe the organisation’s processes for identifying and assessing climate-related risks. Integrated climate assessments inform the enterprise of specific risks and opportunities posed by climate change and/or transition to a low-carbon economy. Each business area is responsible for managing identified climate risks related to its area. pages 1 to 3 and 5 to 7 pages 54, 55 and 96 pages 16 to 23 Describe the organisation’s processes for managing climate-related risks. We have screened and assessed physical risks from climate change across our operations and strategic suppliers to understand our exposure in the value chain at a product level. Identified risks are addressed in local business continuity plans or by technical mitigations in site master plans. Mid- and long-term financial planning includes required investments. To understand the financial consequences of transition to a low-carbon economy, risks and opportunities are assessed both at enterprise and product levels for examples of medicines where LCA data is available. Our Ambition Zero Carbon strategy is reducing our GHG footprint, mitigating some transition risks, and protecting revenue. pages 1 to 3 and 5 to 10 pages 48, 54, 55 and 96 pages 16 to 23 Describe how processes for identifying, assessing, and managing climate-related risks are integrated into the organisation’s overall risk management. Identified risks at corporate level are cascaded throughout the organisation. Business unit management have responsibility for risks in their area. Risks identified at local level are managed locally and escalated to functional and/ or enterprise level if significant, in line with our established enterprise risk management framework. pages 1 to 3 and 5 to 7 pages 54, 55 and 96 pages 16 to 23 Metrics and targets Disclose the metrics used by the organisation to assess climate-related risks and opportunities in line with its strategy and risk management process. Scope 1 and 2 GHG emissions are reported in line with World Resources Institute GHG Protocol guidance and disclosed in our Sustainability Report on our website, www.astrazeneca.com/sustainability/resources.html. page 11 pages 48 and 230 pages 17 to 19 and 32 to 34 Disclose Scope 1, Scope 2 and, if appropriate, Scope 3 GHG emissions and the related risks. GHG footprint and progress towards all targets are reported in line with World Resources Institute GHG Protocol guidance and disclosed in our Sustainability Report on our website, www.astrazeneca.com/sustainability/ resources.html. pages 48 and 230 pages 17 to 19 and 32 Describe the targets used by the organisation to manage climate-related risks and opportunities and performance against targets. Relevant metrics and KPIs in our Sustainability Report show progress on decarbonisation and reduced exposure to transition risks, as well as showing future opportunities. Achieve 98% absolute reduction in Scope 1 and Scope 2 GHG emissions by 2026 from a 2015 baseline. pages 1 to 2 page 48 pages 17 to 19 and 32 AstraZeneca Annual Report & Form 20-F Information 2023 53 Strategic Report Corporate Governance Financial Statements Additional Information Task Force on Climate-related Financial Disclosures Summary Statement |
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Managing risk Our approach to risk management is designed to encourage clear decision making on which risks we take and how we manage these risks. We strive to embed sound risk management in our strategy, planning, budgeting and performance management processes. The Board defines the Group’s risk appetite. This enables the Group, in both quantitative and qualitative terms, to judge the level of risk it is prepared to take in achieving its overall objectives. The Board expresses the acceptable levels of risk for the Group using three key dimensions. These are: (i) earnings and cash flow, (ii) return on investment and (iii) ethics and reputation. Annually, the Group develops a detailed three-year bottom-up business plan and 10-year long-range projection to support the delivery of its strategy. The Board considers these in the context of the Group’s risk appetite. Adjustments are made to the plan or risk appetite to ensure they remain aligned. The SET is required by the Board to oversee and monitor the effectiveness of the risk management processes implemented by management. Within each SET function, leadership teams discuss the risks the business faces. Quarterly, each SET function assesses changes to these risks, new and emerging risks and mitigation plans. These are assimilated into a Group Risk Report for the Board, Audit Committee and SET. Global Compliance, Finance and Global Internal Audit support the SET by advising on policy and standard setting, monitoring and auditing, communication and training, as well as reporting on the adequacy of line management processes as they apply to risk management. The Board believes that existing processes provide it with adequate information on the risks and uncertainties we face. The Board has carried out a robust assessment of the Principal and emerging risks facing the Group. Our Principal Risks are those risks that are most likely to have a material impact on our business and are a subset of the total risk landscape facing the Group. The table on pages 56 and 57 provides insight into these Principal Risks. Emerging risks Emerging risks are ‘new’ risks that have the potential to crystallise in the future but are unlikely to impact the business during the next year. The outcome of such risks is often more uncertain. They may begin to evolve rapidly or simply not materialise. We monitor our business activities and external and internal environments for new, emerging and changing risks to ensure these are managed appropriately. Annually, we combine input from each SET function and external insight to scan the horizon for emerging risks and a summary is presented to the Audit Committee and Board. Emerging risks continue to be monitored as part of the ongoing risk management processes outlined above. Climate risk The identification and assessment of climate risk form part of our existing risk management processes. ‘Failure to meet regulatory and ethical expectations on environmental impact, including climate change’ is a component of the Group’s risk landscape but is not currently considered to be a Principal Risk for the Group. We support the TCFD framework and continue to develop our disclosures in line with its recommendations. Our TCFD Summary Statement from page 51 summarises the work undertaken to date to understand the potential impact of climate change on our business and outlines future areas of management focus. Cybersecurity risk Our approach to identifying, assessing and managing material cybersecurity risks (including those that result from the use of third parties in business processes and data management) is integrated within our Group-wide approach to managing risk. Failure in information technology or cybersecurity has been identified as a Principal Risk. Mitigations are in place to manage these risks, and these are monitored, and their effectiveness regularly reported, for example, in KPI dashboards provided to management and the Audit Committee. Incidents are managed and reported using the cybersecurity incident management framework which in turn is connected to the Group’s crisis management framework. Cybersecurity risks are overseen by the Audit Committee, which performs an in-depth review annually. Its reviews are supported by senior management, the VP, Group Internal Audit and other assurance or providers as required. Cybersecurity risks (including previous incidents) have not materially affected our business strategy, results of operations or financial condition. “Our Principal Risks are those risks that are most likely to have a material impact on our business.” 54 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Risk Overview |
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Viability statement In accordance with provision 31 of the 2018 UK Corporate Governance Code, the Board has determined that a three-year period to 31 December 2026 constitutes an appropriate period over which to provide its viability statement. The Board assesses the Company’s prospects using a 10-year long-range projection. It notes the rich and varied portfolio of medicines in development across a range of therapy areas and the medicines currently commercialised in more than 100 markets and concludes that the Company’s long-term prospects remain strong. The Board also considers annually and on a rolling basis, a three-year bottom-up detailed business plan and, given the inherent uncertainty involved, believes that the three-year statement presents readers of this Annual Report with a reasonable degree of assurance over the ongoing viability of the Company while still providing a longer-term perspective. The three-year detailed business plan captures risks to the sales and cost forecasts at a market and SET function level. The plan is used to perform central net debt and headroom profile analysis. The following scenarios have been applied to this analysis to create a severe but plausible downside combining a number of the Principal Risks detailed from pages 56 to 57. > Principal Risks: Pricing, affordability, access and competitive pressures; failures or delays in the quality or execution of the Group’s commercial strategies. – Scenario 1 – Government action on pricing, higher than anticipated competition and other commercial headwinds result in lower than anticipated growth rates for our medicines. – Scenario 2 – A significant incident leads to reputational damage in a key market resulting in an ongoing 10% reduction in revenue achieved in this market. > Principal Risk: Failure or delay in the delivery of our pipeline or launch of new medicines. – Scenario 3 – Assumes no launches of new products. > Principal Risk: Failure to maintain supply of compliant, quality medicines. – Scenario 4 – Major equipment failure or significant regulatory observation at one of our major manufacturing sites results in a 12-month loss of formulation capability for one of our key oncology products leading to supply interruption. > Principal Risks: Failure in information technology or cybersecurity; adverse outcome of litigation and/or government investigations. – Scenario 5 – Legal, regulatory, cyber or other non-compliance results in a payment of $500 million in 2025. In addition, the Board has considered more stressed scenarios, including restrictions on debt factoring and no access to capital markets to raise new debt. In each scenario (or combination of scenarios above), the Group is able to rely on its existing cash, cash equivalents and short-term fixed income investments, committed credit facilities, leveraging its cost base, reducing capital expenditure and taking other cash management measures to mitigate the impacts and still have residual capacity to absorb further shocks. Based on the results of this analysis, the Directors have a reasonable expectation that the Company will be able to continue in operation and meet its liabilities, as they fall due, over the three-year period of their assessment. “We monitor our business activities and external and internal environments for new, emerging and changing risks to ensure these are managed appropriately.” Full details are given in the Risk Supplement on our website, www.astrazeneca.com/ annualreport2023. AstraZeneca Annual Report & Form 20-F Information 2023 55 Strategic Report Corporate Governance Financial Statements Additional Information Risk Overview |
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Risk category and Principal Risks Context/potential impact Management actions Trend versus prior year Product pipeline risks Failure or delay in the delivery of our pipeline or launch of new medicines The development of pharmaceutical product candidates is a complex, risky and lengthy process involving significant resources. A project may fail at any stage of the process due to a number of factors, which could adversely affect our future business and results of operations. > Prioritise and accelerate our pipeline. > Strengthen pipeline through acquisitions, licensing and collaborations. > Focus on innovative science in our main therapy areas. > Improve R&D productivity. Failure to meet regulatory or ethical requirements for medicine development or approval We are subject to laws and regulations that control our ability to market our pharmaceutical products. Delays in regulatory approvals could delay our ability to market our products and may adversely affect our revenue. > Quality management systems incorporating monitoring, training and assurance activities. > Collaborating with regulatory bodies and advocacy groups to monitor and respond to changes in the regulatory environment, including revised processes, timelines and guidance. Commercialisation risks Pricing, affordability, access and competitive pressures Global economic, political and social pressures are creating an ever more challenging environment in which we operate. Global financial pressures may lead to the implementation of further cost containment measures by payers which could have an adverse effect on our business results. > Implement pricing, reimbursement and policy frameworks. > Focus on key products. > Demonstrate value of medicines/health economics. > Implement innovative value-based agreements focused on patient outcomes. > Global footprint. > Diversified portfolio. Global economic and political conditions placing downward pressure on healthcare pricing and spending and therefore on revenue and innovation. Failures or delays in the quality or execution of the Group’s commercial strategies A failure to execute our commercial strategies or achieve the level of sales anticipated for a medicine could materially impact our business results. > Focus on key products. > Substantial investment in sales and marketing activities. > Accelerate execution of plans and risk share through business development and strategic collaborations and alliances. Supply chain and business execution risks Failure to maintain supply of compliant, quality medicines Supply chain difficulties may result in product shortages which could lead to lost product sales and materially affect our reputation and revenues. > Establishment of new manufacturing facilities, creating capacity and technical capability to support new product launches. > Contingency plans, including dual sourcing, multiple suppliers and close monitoring and maintenance of stock levels. > Business continuity and resilience initiatives, disaster and data recovery, and emergency response plans. > Quality management systems. Failure in information technology or cybersecurity Significant disruption to our IT systems, including breaches of data security or cybersecurity, or failure to comply with applicable laws or regulations could harm our reputation and materially affect our financial condition or results of operations. > Cybersecurity incident management framework and dashboard. > Disaster and data recovery plans. > Strategies to secure critical systems and processes. > Regular cybersecurity and privacy training for employees. Growing multi-faceted cyber threat. Failure to attract, develop, engage and retain a diverse, talented and capable workforce The inability to attract and retain highly-skilled personnel may weaken our succession plans for critical positions, impact the implementation of our strategic objectives, and ultimately result in the failure of our business operations. > Targeted recruitment and retention strategies deployed to secure critical skills and capabilities. > Development of our employees. > Evolve our culture. Principal Risks Strategy key Science and Innovation Growth and Therapy Area Leadership People and Sustainability Achieve Group Financial Targets Trend key Increasing risk Decreasing risk Unchanged 56 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Risk Overview continued |
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Risk category and Principal Risks Context/potential impact Management actions Trend versus prior year Legal, regulatory and compliance risks Safety and efficacy of marketed medicines is questioned Safety concerns relating to our products may lead to recalls, seizures, interruption of supply and loss of product approvals, which could adversely affect patient access, our reputation and our revenues. Significant product liability claims could also arise, which may be costly, divert management attention, reduce demand for our products and damage our reputation. > Robust processes and systems in place to manage patient safety and efficacy trends as well as externally reported risks through regulatory agencies and other parties. This includes a comprehensive pharmacovigilance programme supplemented by close monitoring and review of adverse events. Adverse outcome of litigation and/or governmental investigations Our business is subject to a wide range of laws and regulations around the world. Actual or perceived failure to comply may result in AstraZeneca being investigated by government agencies and authorities and/or in civil legal proceedings. Government investigations, litigations, and other legal proceedings, regardless of outcome, could be costly, divert management attention, or damage our reputation and demand for our products. Unfavourable resolutions to proceedings against us could subject us to criminal liability, fines, penalties or other monetary or non-monetary remedies, including enhanced damages, require us to make significant provisions in our accounts relating to legal proceedings and could materially adversely affect our business or results of operations. > Established compliance framework with strong ethical and compliance culture. > Combined internal and external counsel management. IP risks related to our products The pharmaceutical industry is experiencing pressure from governments and other payers to impose limits on intellectual property (IP) protections to manage healthcare costs. If we are unable to obtain, defend and enforce our IP, we may experience accelerated and intensified competition. > Active management of IP rights and IP litigation. Economic and financial risks Geopolitical and/or macro-economic volatility disrupts the operation of our global business Operating in more than 100 countries, we are subject to political, socio-economic and financial factors around the world. A sustained global economic downturn may adversely impact our business. Geopolitical tensions may lead to the imposition or escalation of trade controls, tariffs, taxes or other restrictions to market access, which may increase our costs or reduce revenues. > Focus on key products. > Demonstrate value of medicines/health economics. > Diversified portfolio. Failure to achieve strategic plans or meet targets or expectations Failure to successfully implement our business strategy may frustrate the achievement of our targets and materially damage our brand, business, financial position or results of operations. > Focus on key products and innovative science in our core therapy areas. > Strengthen pipeline through acquisitions, licensing and collaborations. > Appropriate capital structure and balance sheet. > Portfolio-driven decision-making process governed by senior executive-led committees. Risk Overview AstraZeneca Annual Report & Form 20-F Information 2023 57 Strategic Report Corporate Governance Financial Statements Additional Information |
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2023 represented another year of excellent performance. We started the year with several operational uncertainties, including revenues from our COVID-19 mAbs and certain other products. Despite some of these risks materialising, the vast majority of the portfolio outperformed expectation, leading to an exceptional year. This speaks to the strength of our diversified portfolio and geographic footprint. Our R&D teams are progressing novel medicines and we continue to enhance our portfolio though business development and mergers and acquisitions. At the same time, we continue to optimise ‘how work is done’, expanding services offered in our shared business Centres of Excellence. Our colleagues across functions remain focused on quality, reporting, controls, cybersecurity, and supply, while incorporating a mindset of continuous improvement. Total Revenue growth AstraZeneca achieved Total Revenue of $45.8 billion in 2023, including $1.4 billion of Alliance Revenue and $0.6 billion of Collaboration Revenue with growth of 3% (CER: 6%). 2023 delivered 13 blockbuster medicines in total. Excluding COVID-19 medicines, Total Revenue increased by 13% (CER: 15%) in the year. Product Sales grew by 2% (CER: 4%) to $43.8 billion, with 12 blockbuster medicines, including Ultomiris, Soliris and Strensiq from our Rare Disease portfolio. Our continued investment in Oncology and CVRM medicine launches supported sustained Product Sales growth, with Oncology achieving 17% (CER: 20%) and CVRM achieving 15% (CER: 18%). Standout performances came once again from Farxiga ($6.0 billion), Tagrisso ($5.8 billion) and Imfinzi ($4.2 billion). Within our Rare Disease portfolio, Soliris achieved Product Sales of $3.1 billion but saw a decline of 16% (CER: 14%) due to the successful conversion to Ultomiris, which had growth of 51% (CER: 52%) to $3.0 billion in the year. In the US, we had overall growth of 4%, with Product Sales of $18.0 billion. In Emerging Markets, Product Sales grew by 1% (CER: 8%) to $11.8 billion, with growth in CVRM and Tagrisso. In Europe, Product Sales increased by 9% (CER: 7%) to $9.0 billion, reflecting strong performances from Oncology and Forxiga and in Established Rest of World markets, there was a decline of 14% (CER: 8%) to $5.0 billion due to mandatory pricing reductions of Tagrisso in Japan and the drop off in demand for COVID-19 medicines. Alliance Revenue increased by 89% (CER: 89%) to $1.4 billion, including $1.0 billion from Enhertu, which achieved blockbuster status for the first time. Collaboration Revenue declined by 1% (CER: 1%) to $0.6 billion. Profitability Reported EPS was $3.84 in the year (2022: $2.12) and Core EPS was $7.26 (2022: $6.66) driven by improved Product Sales Gross Margin from Total Revenue growth and a decline in sales of lower margin COVID-19 medicines. “AstraZeneca achieved Total Revenue of $45.8 billion in 2023, with growth of 3% (CER: 6%), including $1.4 billion of Alliance Revenue and $0.6 billion of Collaboration Revenue. Excluding COVID-19 medicines, Total Revenue increased by 13% (CER: 15%).” 2023 was a year of strong business performance, with sustained revenue growth and excellent pipeline progress. Key milestones/approvals Our continued investment in the pipeline yielded several significant approvals and milestones in the year, including regulatory approval in the US for Truqap in breast cancer, Wainua (eplontersen) in transthyretin-mediated amyloid polyneuropathy and Beyfortus for the prevention of RSV in infants. In Japan, in January 2024, Voydeya was approved for the treatment of anaemia due to extravascular haemolysis. 2023 also afforded me the opportunity to engage with a number of our stakeholders – from investors to key opinion leaders and physicians at congresses, and from employees to government officials. This brought to light how special a place AstraZeneca truly is. Our stakeholders see AstraZeneca as a company on the forefront of science with a broad ambition to continuously improve health, our communities and our planet. During all my interactions, I have been impressed with the engagement, energy and passion of my colleagues and humbled by the privilege of working with an amazing set of people. 2024 will bring more change and we will continue to evolve while remaining true to our Values. Aradhana Sarin Chief Financial Officer 58 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Financial Review |
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Product Sales roball oC t a oi n Revenue Operating profit EPS All ai nce Rev ne eu Highlights Financial performance Total Revenue: Therapy Areas Total Revenue: Geographical Areas Emerging Markets 2% growth (CER: 9%) CVRM 15% growth (CER: 18%) US 6% growth Oncology 19% growth (CER: 21%) Europe 10% growth (CER: 8%) Rare Disease 10% growth (CER: 12%) Established RoW -14% decrease (CER: -8%) Respiratory & Immunology 7% growth (CER: 10%) Vaccines & Immune Therapies -72% decrease (CER: -71%) Other Medicines -31% decrease (CER: -27%) Summary performance in 2023 Reported CER Core 2023 $m 2022 $m % Actual change CER growth2 $m Growth due to exchange effects $m % CER change 2023 $m 2022 $m % Actual change Product Sales 43,789 42,998 2 1,786 (995) 4 43,789 42,998 2 Alliance Revenue 1,428 755 89 670 3 89 1,428 755 89 Collaboration Revenue 594 598 (1) (7) 3 (1) 594 598 (1) Total Revenue 45,811 44,351 3 2,449 (989) 6 45,811 44,351 3 Cost of sales (8,268) (12,391) (33) 4,141 (18) (34) (8,011) (8,588) (7) Gross profit 37,543 31,960 17 6,590 (1,007) 21 37,800 35,763 6 Operating expenses (30,690) (28,717) 7 (2,305) 332 8 (24,545) (22,860) 7 Other operating income and expense 1,340 514 >2x 825 1 >2x 1,279 447 >2x Operating profit 8,193 3,757 >2x 5,110 (674) >2x 14,534 13,350 9 Net finance expense (1,282) (1,251) 2 (16) (15) 1 (984) (974) 1 Share of after tax losses of joint ventures and associates (12) (5) >2x (6) (1) >2x (12) (5) >2x Profit before tax 6,899 2,501 >2x 5,088 (690) >2x 13,538 12,371 9 Taxation (938) 792 n/m (1,855) 125 n/m (2,291) (2,058) 11 Profit after tax 5,961 3,293 81 3,233 (565) 96 11,247 10,313 9 Basic earnings per share ($) 3.84 2.12 81 2.09 (0.37) 96 7.26 6.66 9 1 Effective 1 January 2023, the Group has updated the presentation of Total Revenue. For further details of the presentation of Alliance Revenue and Collaboration Revenue, see the Basis of accounting and preparation of financial information on page 152. 2 As detailed on page 61, CER growth is calculated using prior year actual results adjusted for certain exchange rate effects, including hedging. $43.8bn 2% growth (CER: 4%) $1.4bn 89% growth (CER: 89%) $8.2bn 118% growth (CER: >2x) $0.6bn -1% decrease (CER: -1%) $14.5bn 9% growth (CER: 14%) $3.84 81% growth (CER: 96%) $7.26 9% growth (CER: 15%) Product Sales Alliance Revenue1 Operating profit – Reported Operating profit – Core Collaboration Revenue1 EPS – Reported EPS – Core AstraZeneca Annual Report & Form 20-F Information 2023 59 Strategic Report Corporate Governance Financial Statements Additional Information Financial Review |
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Business background and results overview The business background is covered in the Healthcare in a Changing World section from page 7, the Therapy Area Review from page 16, and the Our Strategy and Key Performance Indicators section from page 12, which describe in detail the business developments of our products. As described earlier in this Annual Report, sales of our products are directly influenced by medical need and are generally paid for by health insurance schemes or national healthcare budgets. Our operating results can be affected by a number of factors other than the delivery of operating plans and normal competition. Over the longer term, the success of our R&D is crucial and we devote substantial resources to this area. The benefits of this investment are expected to emerge over the long term and there is considerable inherent uncertainty as to the scale and timing of outcomes and their transition to saleable products. Measuring performance Reported and Core performance are referred to in this Financial Review when reporting on our performance in absolute terms, but more often in comparison with earlier years: > Reported performance takes into account all the factors (including those which we cannot influence, such as currency exchange rates) that have affected the results of our business. The Consolidated Financial Statements have been prepared in accordance with UK-adopted IAS and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards. The Consolidated Financial Statements also comply fully with IFRS Accounting Standards as issued by the IASB and IAS as adopted by the EU. > Core performance measures are adjusted to exclude certain significant items, using a set of established principles. Use of non-GAAP performance measures Core performance measures, EBITDA, Net debt, CER, Product Sales Gross Margin (formerly termed Gross Margin) and Operating Margin are non-GAAP performance measures because they cannot be derived directly from the Financial Statements. By disclosing non-GAAP performance and growth measures, in addition to our Reported financial information, we are enhancing investors’ ability to evaluate and analyse the financial performance and trends of our ongoing business and the related key business drivers. The adjustments are made to our Reported financial information in order to show non-GAAP performance measures that illustrate clearly the impact on our performance of factors such as changes in revenues and expenses driven by volume, prices and cost levels relative to such prior years or periods. These non-GAAP performance measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP. As shown in the 2023 Reconciliation of Reported results to Core results table on page 62, our reconciliation of Reported financial information to Core performance measures includes a breakdown of the items for which our Reported financial information is adjusted, and a further breakdown by specific line item as such items are reflected in our Reported income statement. This illustrates the significant items that are excluded from Core performance measures and their impact on our Reported financial information, both as a whole and in respect of specific line items. Management presents these results externally to meet investors’ requirements for transparency and clarity. Core financial measures are also used internally in the management of our business performance, in our budgeting process and when determining compensation. As a result, Core performance measures allow investors to differentiate between different kinds of costs but they should not be used in isolation. Our determination of non-GAAP measures, and our presentation of them within this Financial Review, may differ from similarly titled non-GAAP measures of other companies. The SET retains strategic management of the costs excluded from Reported financial information in arriving at Core financial measures, tracking their impact on Reported Operating profit and EPS, with operational management being delegated on a case-by-case basis to ensure clear accountability and consistency for each cost category. We strongly encourage readers of this Annual Report not to rely on any single financial measure but to review our Financial Statements, including the Notes thereto, and our other publicly filed reports, carefully and in their entirety. Further details of the risks faced by the business are given in Risk Overview from page 54 and in the Risk Supplement at www.astrazeneca.com/ annualreport2023. For a detailed definition of Core measures, see page 61. Readers should also refer to our Reported financial information in the Summary performance in 2023 table on page 59, our reconciliation of Core performance measures to Reported financial information in the 2023 Reconciliation of Reported results to Core results table and the Excluded from Core results table on page 63, for our discussion of comparative growth measures that reflect all factors that affect our business. 60 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Financial Review continued |
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Non-GAAP measures: definitions Revenue Constant exchange rate (CER) growth rates Reconciliation, see page 62 Definition: Retranslation of the current year’s performance at the previous year’s average exchange rates, adjusted for other exchange effects, including hedging. Why we use them: CER measures allow us to focus on the changes in revenues and expenses driven by volume, prices and cost levels relative to the prior period. Revenues and cost growth expressed in CER allow management to understand the true local movement in revenues and costs, in order to compare recent trends and relative return on investment. CER growth rates can be used to analyse revenues in a number of ways but, most often, we consider CER growth by products and groups of products, and by countries and regions. CER revenue growth can be further analysed by revenue volumes and selling price. Similarly, CER cost growth helps us to focus on the real local change in costs so that we can manage the cost base effectively. Limitations: CER measures are not always better indicators of performance. Where countries are subject to high inflation and currencies that depreciate persistently, adjusting out the effect of foreign exchange fluctuations could give an overly optimistic view of growth. Profitability Core performance measures Reconciliation, see page 62 Core performance measures are adjusted to exclude certain significant items. In determining the adjustments to arrive at the Core result, we use a set of established principles relating to the nature or materiality of individual items or groups of items, excluding, for example, events which are (i) outside the normal course of business, (ii) incurred in a pattern that is unrelated to the trends in the underlying financial performance of our ongoing business, or (iii) related to major acquisitions, to ensure that investors’ ability to evaluate and analyse the underlying financial performance of our ongoing business is enhanced. Our Core adjustments are summarised as: Restructuring costs, including charges that relate to the impact of our global restructuring programmes on our capitalised manufacturing facilities and IT assets. These can take place over multiple reporting periods, given the long life-cycle of our business. Why we use them: We adjust for these charges and provisions because they primarily reflect the financial impact of change to legacy arrangements, rather than the underlying performance of our ongoing business. Intangible amortisation and impairments, including impairment reversals but excluding any charges relating to IT assets. Intangibles generally arise from business combinations and individual licence acquisitions. Why we use them: We adjust for these charges because their pattern of recognition is largely uncorrelated with the underlying performance of the business. Alexion acquisition-related items, primarily fair value adjustments on acquired inventories and fair value impact of replacement employee share awards. Why we use them: We adjust for this item to enable a more meaningful comparison of the performance of acquired business and products to that of internally developed products, as well as removing charges whose pattern of recognition is largely uncorrelated to the underlying performance of the business. Other specified items, principally the imputed finance charges and fair value movements relating to contingent consideration on business combinations, imputed finance charges and remeasurement adjustments on certain Other payables arising from intangible asset acquisitions, legal settlements and remeasurement adjustments relating to Other payables assumed from the Alexion acquisition. Why we use them: We adjust for these items to enable a more meaningful comparison of the performance of acquired businesses and products to that of internally developed products, as well as removing charges whose pattern of recognition is largely uncorrelated to the underlying performance of the business. It should be noted that some costs excluded from our Core results, such as intangibles amortisation and finance charges related to contingent consideration, will recur in future years, and other excluded items such as impairments and legal settlements costs, along with other acquisition-related costs, may recur in the future. Limitations: Core results exclude significant costs (such as restructuring, intangible amortisation and impairments, and other acquisition-related adjustments), but incorporate associated benefits, including Product Sales arising from business combinations, asset acquisitions and assets which have been amortised, as well as the benefits resulting from restructuring activities and, as such, they should not be regarded as a complete picture of the Group’s financial performance, which is presented in its Reported results. The exclusion of the adjusting items may result in Core earnings being materially higher or lower than Reported earnings. Product Sales Gross Margin Reconciliation, see page 62. Definition: Product Sales Gross Margin (formerly termed Gross Margin) is the percentage by which Product Sales exceeds the Cost of sales, calculated by dividing the difference between the two by the sales figure. The calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenue and Collaboration Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales. Why we use it: This measure sets out gross profitability of Product Sales when taking account of only direct Cost of sales. It is a key performance measure of the contribution to fund operating costs and overall quality of the business. Limitations: Product Sales Gross Margin percentage excludes the impact of Alliance Revenue and Collaboration Revenue and related costs and therefore should not be regarded as giving a full picture of Total Revenue performance. AstraZeneca Annual Report & Form 20-F Information 2023 61 Strategic Report Corporate Governance Financial Statements Additional Information Financial Review |
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Operating Margin percentage Reconciliation, see table below. Definition: Operating profit as a percentage of Total Revenue. Why we use it: This measure sets out profitability derived from operating activities before the impact of finance costs and tax. It is a key performance measure of the overall quality of the operations of the business. Limitations: Operating Margin percentage excludes the impact of financing costs and therefore should not be regarded as a full picture of revenue performance. EBITDA Reconciliation, see page 67. Definition: Reported Profit before tax plus Net finance expense, Share of after-tax losses of joint ventures and associates, and charges for Depreciation, amortisation and impairment. Why we use it: EBITDA allows us to understand our baseline profitability, removing any ‘non-operational’ expenses and non-cash items that are not considered by management to be reflective of the underlying performance of the Group. Limitations: EBITDA does not take account of the cost of investment to generate revenues, hence is not always the best indicator of performance. Cash flow and liquidity Net debt Reconciliation, see page 69. Definition: Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments and Net derivative financial instruments. Why we use it: Net debt is a measure that provides valuable additional information regarding the Group’s net financial liabilities and is a measure commonly used by investors and rating agencies. It facilitates the tracking of one of our key financial priorities: deleveraging. 2023 Reconciliation of Reported results to Core results 2023 Reported $m Restructuring costs $m Intangible amortisation and impairments $m Acquisition of Alexion $m Other1 $m 2023 Core2 $m Core 2023 compared with Core 20222 Actual growth % CER growth % Gross profit 37,543 109 32 119 (3) 37,800 6 9 Product Sales Gross Margin % 81.1 81.7 Distribution expense (539) – – – – (539) 1 2 Research and development expense (10,935) 212 447 7 2 (10,267) 8 9 Selling, general and administrative expense (19,216) 207 3,801 11 1,458 (13,739) 7 9 Other operating income and expense 1,340 (61) – – – 1,279 >2x >2x Operating profit 8,193 467 4,280 137 1,457 14,534 9 14 Operating Margin % 17.9 31.7 Net finance expense (1,282) – – – 298 (984) Taxation (938) (107) (809) (32) (405) (2,291) Basic earnings per share ($) 3.84 0.23 2.24 0.07 0.88 7.26 9 15 2022 Reconciliation of Reported results to Core results 2022 Reported $m Restructuring costs $m Intangible amortisation and impairments $m Acquisition of Alexion $m Other1 $m 2022 Core2 $m Core 2022 compared with Core 20212 Actual growth % CER growth % Gross profit 31,960 266 32 3,506 (1) 35,763 28 35 Product Sales Gross Margin % 71.2 80.0 Distribution expense (536) 2 – – – (534) 20 28 Research and development expense (9,762) 111 124 27 – (9,500) 19 24 Selling, general and administrative expense (18,419) 405 4,165 38 985 (12,826) 15 21 Other operating income and expense 514 (67) – – – 447 (70) (69) Operating profit 3,757 717 4,321 3,571 984 13,350 34 42 Operating Margin % 8.5 30.1 Net finance expense (1,251) – – – 277 (974) Taxation 792 (165) (804) (832) (1,049) (2,058) Basic earnings per share ($) 2.12 0.36 2.27 1.77 0.14 6.66 26 33 1 See Excluded from Core results table on following page for further details of other adjustments. 2 Each of the measures in the Core columns is a non-GAAP measure. Non-GAAP measures: definitions continued 62 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Financial Review continued |
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Excluded from Core results Restructuring costs > Restructuring costs totalling $467 million (2022: $717 million) mainly comprise those incurred on the Post Alexion Acquisition Group Review (PAAGR) of $362 million (2022: $675 million). Intangible amortisation and impairments > Amortisation totalling $3,846 million (2022: $4,080 million) relating to intangible assets, except those related to IT. Further information on our intangible assets is contained in Note 10 to the Financial Statements from page 172. Intangible impairment charges were $434 million (2022: $318 million), excluding those related to IT. Further details relating to intangible asset impairments are included in Note 10 to the Financial Statements from page 172. Acquisition of Alexion > Costs associated with our acquisition of Alexion in July 2021 amounting to $137 million (2022: $3,571 million), primarily relating to the impact from the unwind of the fair value adjustment to Alexion inventories at the date of acquisition. In 2023, the impact of the fair value uplift unwind on Cost of sales is $114 million (2022: $3,484 million). The majority of the fair value uplift unwound through Reported Cost of sales in line with associated revenues in 2022. > The fair value of replacement employee share awards is higher than both the value of the Alexion awards the employees were originally granted and the expected value of future awards to those employees. As a result, the Group will recognise an inflated expense during the remaining vesting period of these awards. This temporary increase in Operating expenses, when compared with the expected expense based on the grant-date value, will be excluded from the Group’s Core results. > Other acquisition-related items to be excluded from the Group’s Core results include professional fees, retention bonuses included in the acquisition agreement and the effect of unwinding other acquisition-related fair value adjustments over time. Other > Other adjustments, excluding taxation adjustments, amounted to $1,755 million (2022: $1,261 million). > Other adjustments to Reported SG&A expenses were $1,458 million (2022: $985 million), primarily including a charge to legal provisions of $425 million in relation to Nexium and Losec/Prilosec product liability litigation, $510 million in relation to Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC and $70 million in relation to Alexion shareholder litigation. Other adjustments also include $549 million (2022: $82 million) net fair value adjustments relating to contingent consideration balances, and a credit of $111 million (2022: a charge of $82 million) of remeasurement adjustments relating to Other payables. Further details relating to contingent consideration balances are contained in Note 20 to the Financial Statements from page 181, and further details of legal proceedings, ongoing at 31 December 2023, are contained within Note 30 to the Financial Statements from page 204. > Other adjustments to Net finance expense of $298 million (2022: $277 million) include discount unwind charges on liabilities arising from business combinations and on liabilities resulting from the Enhertu collaboration agreement. > Other adjustments to Taxation amounted to $405 million (2022: $1,049 million). Adjustments to Taxation in 2022 included a one-time favourable net adjustment of $876 million to deferred taxes arising from an internal reorganisation to integrate Alexion. AstraZeneca Annual Report & Form 20-F Information 2023 63 Strategic Report Corporate Governance Financial Statements Additional Information Financial Review |
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Product Sales 2023 Product Sales $m 2022 Product Sales $m Actual growth % CER growth % Product Sales by Therapy Area Oncology 17,145 14,631 17 20 CVRM 10,585 9,188 15 18 Rare Disease 7,764 7,053 10 12 Respiratory & Immunology 6,107 5,765 6 8 Vaccines & Immune Therapies 1,012 4,736 (79) (78) Other Medicines 1,176 1,625 (28) (24) Total 43,789 42,998 2 4 2023 Product Sales $m 2022 Product Sales $m Actual growth % CER growth % Product Sales by geographical area US 17,961 17,254 4 4 Emerging Markets 11,751 11,634 1 8 Europe 9,029 8,264 9 7 Established RoW 5,048 5,846 (14) (8) Total 43,789 42,998 2 4 Total Revenue1 Total Revenue for 2023 was up 3% (CER: 6%) to $45,811 million, comprising Product Sales of $43,789 million, up 2% (CER: 4%), Alliance Revenue1 of $1,428 million, an increase of 89% (CER: 89%), and Collaboration Revenue1 of $594 million, a decrease of 1% (CER: 1%). 1 Effective 1 January 2023, the Group has updated the presentation of Total Revenue. For further details of the presentation of Alliance Revenue and Collaboration Revenue, see Basis of accounting and financial information on page 152. Product Sales By geography US Product Sales were up 4% to $17,961 million, reflecting the continued growth of our Oncology medicines and Farxiga, which had growth of 35%, with recent launches in HF and CKD driving an increase in market share. Product Sales in Emerging Markets grew by 1% (CER: 8%) to $11,751 million in 2023 with growth in CVRM, Respiratory & Immunology and Tagrisso. Product Sales in ex-China Emerging Markets remained broadly flat (CER: growth of 8%) at $5,884 million, with increases in Oncology and Farxiga offset by declines in COVID-19 medicines. In Europe, Product Sales grew by 9% (CER: 7%) to $9,029 million, reflecting a strong performance in Oncology and Forxiga but also reflecting COVID-19 medicines decline. Established Rest of World Product Sales decreased by 14% (CER: 8%) to $5,048 million, with sales in Japan down 9% (CER: 1%) to $3,654 million, driven by decline in COVID-19 medicines partially offset by increases in Oncology. By Product 2023 succeeded in delivering 12 blockbuster drugs. Our largest selling products in the year were Farxiga ($5,963 million), Tagrisso ($5,799 million), Imfinzi ($4,237 million), Soliris ($3,145 million), and Ultomiris ($2,965 million). Farxiga sales increased by 36% (CER: 39%), with continued volume growth across all major regions driven by launches in HF and CKD. Tagrisso sales grew by 7% (CER: 9%) reflecting a strong performance from increased demand across all markets. Imfinzi Product Sales grew by 52% (CER: 55%), with increased use worldwide driven by new launches and established indications. Soliris declined by 16% (CER: 14%) due to the successful conversion to Ultomiris, which increased by 51% (CER: 52%). Calquence continued its growth with an increase of 22% (CER: 23%) in the year to $2,514 million driven by increased market penetration globally, including increased new patient starts in Europe and sustained US performance. Within Vaccines & Immune Therapies, Product Sales declined by 79% (CER: 78%) due to fulfilment of contracts signed during the pandemic. 64 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Financial Review continued |
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Alliance Revenue 2023 $m 2022 $m Alliance Revenue Enhertu 1,022 523 Tezspire 259 79 Beyfortus 57 – Vaxzevria: royalties – 76 Other royalty income 81 68 Other Alliance Revenue 9 9 Total Alliance Revenue 1,428 755 Alliance Revenue Alliance Revenue increased in the year by 89% (CER: 89%), to $1,428 million, including $1,022 million Alliance Revenue from Enhertu, which achieved blockbuster status for the first time in 2023. Details of our significant business development transactions which give rise to Alliance Revenue are given below. Enhertu (Daiichi Sankyo) In March 2019, AstraZeneca announced it had entered into an alliance with Daiichi Sankyo to develop and commercialise Enhertu for multiple cancer types. In markets where Daiichi Sankyo is selling the product, AstraZeneca is entitled to receive a royalty (in Japan) or a share of costs and income (in other territories). Share of gross profits and royalty income from Daiichi Sankyo are recognised as Alliance Revenue. Enhertu launched in the US on 31 December 2019. Alliance Revenue in respect of this agreement has been recognised as follows: > Prior to 2023, AstraZeneca recognised $806 million in respect of Alliance Revenue. > In 2023, AstraZeneca recognised Alliance Revenue of $1,022 million leading to Enhertu achieving blockbuster status in the year. Tezspire (Amgen) In 2012, AstraZeneca entered into a collaboration agreement with Amgen to co-develop and co-commercialise five development stage programmes. Of these, only AMG 157 (Tezspire tezepelumab) remains in the collaboration. A second active molecule (AZD8630) was added in 2021. Manufacturing will be undertaken by Amgen, while commercialisation activity will be undertaken either jointly, or by AstraZeneca or Amgen individually, dependent on the market and on the agreed terms. AstraZeneca will recognise 100% of the sales as principal in all markets other than the US, as well as 100% of the associated cost of sales. In markets other than the US, where AstraZeneca is recognising sales, the share of gross margin payable to Amgen will be shown as additional cost of sales. In the US, where Amgen is recognising sales, AstraZeneca will record its share of gross profit as Alliance Revenue. Alliance Revenue in respect of this agreement has been recognised as follows: > Prior to 2023, AstraZeneca recognised $79 million in respect of Alliance Revenue. > In 2023, AstraZeneca recognised Alliance Revenue of $259 million. Beyfortus (Sanofi) In March 2017, AstraZeneca entered into an alliance with Sanofi to develop and commercialise Beyfortus jointly. Under the terms of the global agreement, Sanofi made an upfront payment of €120 million and will pay up to €495 million upon achievement of certain development and sales-related milestones. All costs and profits are shared equally. The US element of this collaboration was subject to a participation agreement with Sobi, effective from January 2019 until April 2023, at which point there was an update to the contractual relationships between AstraZeneca, Sobi and Sanofi relating to the future sales of Beyfortus. Alliance Revenue recognises AstraZeneca’s 50% share of gross profits on sales of Beyfortus in major markets outside the US. Alliance Revenue in respect of this agreement has been recognised as follows: > In 2023, AstraZeneca recognised Alliance Revenue of $57 million. Collaboration Revenue Collaboration Revenue decreased in the year by 1% (CER: 1%) to $594 million. Details of our significant business development transactions which give rise to Collaboration Revenue are given below. Lynparza/Koselugo (MSD) In July 2017, the Group announced a global strategic oncology collaboration with MSD to co-develop and co-commercialise AstraZeneca’s Lynparza for multiple cancer types. As part of the agreement, MSD will pay AstraZeneca up to $8.5 billion in total consideration, including $1.6 billion upfront, $750 million for certain licence options and up to $6.2 billion contingent upon successful achievement of future regulatory and sales milestones. Of the upfront payment of $1.6 billion, $1.0 billion was recognised as Collaboration Revenue on deal completion in 2017, with the remaining $0.6 billion deferred to the balance sheet, of which less than $0.1 billion remains for 2023. AstraZeneca records all Collaboration Revenue of Lynparza and Koselugo; amounts due to MSD under the collaboration will be recorded under Cost of sales. Collaboration Revenue in respect of this agreement has been recognised as follows: > Prior to 2023, AstraZeneca recognised Collaboration Revenue totalling $2,865 million, comprising $750 million resulting from the exercise of options, $1,400 million in respect of sales-related milestones and $715 million in respect of regulatory milestones. > In 2023, AstraZeneca recognised Collaboration Revenue of $245 million in respect of regulatory milestones. Collaboration Revenue 2023 $m 2022 $m Collaboration Revenue Lynparza/Koselugo (MSD): regulatory milestones 245 355 COVID-19 mAbs: licence fees 180 – Farxiga: sales milestones 29 – tralokinumab (Leo Pharma A/S): milestones 20 110 Beyfortus: regulatory milestones 71 25 Beyfortus: sales milestones 27 – Nexium: sale of rights – 62 Other Collaboration Revenue 22 46 Total Collaboration Revenue 594 598 AstraZeneca Annual Report & Form 20-F Information 2023 65 Strategic Report Corporate Governance Financial Statements Additional Information Financial Review |
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Other operating income and expense Reported Other operating income and expense in the year was up 161% (CER: 160%) to $1,340 million. Core Other operating income and expense in the year was up 186% (CER: 186%) to $1,279 million. For 2023, both Reported and Core Other operating income and expense were impacted by a gain of $712 million on replacement of the contractual relationship between AstraZeneca, Sobi and Sanofi with a royalty relationship between Sanofi and Sobi and income of $241 million on the disposal of the US rights to Pulmicort Flexhaler. 2022 included royalties and disposal proceeds on small divestments including the divestment of rights to Plendil. In accordance with our Collaboration Revenue definition in the Group Accounting Policies from page 152, proceeds from these divestments are recorded as Other operating income and expense and comprise the majority of Other operating income and expense for the year. Operating profit Reported Operating profit increased by 118% (CER: 134%) to $8,193 million in the year. The Reported Operating Margin increased by nine percentage points (CER: 10) to 17.9% of Total Revenue. Core Operating profit grew by 9% (CER: 14%) in the year to $14,534 million. Net finance expense Reported Net finance expense increased by 2% (CER: 1%) in the year to $1,282 million. Core Net finance expense increased by 1% (CER: decreased by 1%) in the year to $984 million. Reported Net finance expense was impacted by the discount unwind on acquisition-related liabilities. Core Net finance expense increased due to higher interest received on cash and short-term investments, broadly offset by higher rates on floating debt and bond issuances. Profit before tax Reported Profit before tax increased to $6,899 million (2022: $2,501 million). Core Profit before tax increased by 9% (CER: 15%) to $13,538 million. Pre-tax adjustments to arrive at Core Profit before tax amounted to $6,639 million in 2023 (2022: $9,870 million), comprising $6,341 million adjustments to Operating profit (2022: $9,593 million) and $298 million to Net finance expense (2022: $277 million). COVID-19 mAbs (SII) In June 2023, AstraZeneca entered into a sub-licence, commercialisation and manufacturing rights agreement with the Serum Institute of India Ltd (SII) for Evusheld and AZD3152 in India. Collaboration Revenue in respect of this agreement has been recognised as follows: > In 2023, AstraZeneca recognised Collaboration Revenue of $180 million resulting from licence fees. Beyfortus (Sanofi) Details of this business development transaction are summarised in the Alliance Revenue section on page 65. Collaboration Revenue in respect of this agreement has been recognised as follows: > Prior to 2023, AstraZeneca recognised Collaboration Revenue totalling $186 million, comprising $127 million resulting from upfront consideration and $59 million in respect of regulatory milestones. > In 2023, AstraZeneca recognised Collaboration Revenue of $71 million in respect of regulatory milestones, and $27 million in respect of sales-related milestones. Tralokinumab (Leo Pharma A/S) In June 2016, AstraZeneca and Leo Pharma A/S entered into a licence agreement for the global development and commercialisation of tralokinumab. Collaboration Revenue in respect of this agreement has been recognised as follows: > Prior to 2023, AstraZeneca recognised Collaboration Revenue of $115 million in respect of the upfront consideration and $110 million in sales-related milestones. > In 2023, AstraZeneca recognised Collaboration Revenue of $20 million in respect of sales-related milestones. Gross profit Reported Gross profit increased by 17% (CER: 21%) to $37,543 million. Core Gross profit increased by 6% (CER: 9%) to $37,800 million. Reported Product Sales Gross Margin grew by 10 (CER: 10) percentage points to 81.1%. Core Product Sales Gross Margin grew by two (CER: two) percentage points to 81.7%. Both Reported and Core Product Sales Gross Margin reflected positive product mix effects from Rare Disease and Oncology medicines, negative product mix effects from rising contributions of products with share of gross profit arrangements, and negative geographic mix effects as Emerging Markets grew as a proportion of Total Revenue. Reported Gross Margin was impacted by the fair value adjustment to Alexion inventories. The fair value uplift unwind through Cost of sales in 2023 was $114 million (2022: $3,848 million). Operating expenses Reported Operating expenses increased by 7% (CER: 8%) in the year to $30,690 million. Core Operating expenses increased by 7% (CER: 9%) to $24,545 million. Reported R&D expense increased by 12% (CER: 13%) to $10,935 million and Core R&D expense increased by 8% (CER: 9%) to $10,267 million. Both Reported and Core R&D expense were impacted by recent positive data readouts for several high priority medicines and increased investment in new platforms, technologies and capabilities. Reported R&D expense also includes intangible asset impairment charges of $417 million; an increase of $322 million from 2022, which includes $244 million related to the impairment of the ALXN1840 intangible asset, following the decision to discontinue this development programme in Wilson disease. Reported SG&A expense increased by 4% (CER: 6%) to $19,216 million and Core SG&A expense increased by 7% (CER: 9%) to $13,739 million. Both Reported and Core SG&A expense increases were driven primarily by market development activities for launches. Reported SG&A expense was impacted by amortisation of intangible assets related to the Alexion acquisition and other acquisitions and collaborations. Reported SG&A expense was also impacted by a $510 million charge to provisions relating to a legal settlement with Bristol-Myers Squibb and Ono Pharmaceutical, and a $425 million charge to provisions for product liability litigations related to Nexium and Prilosec. The prior year Reported SG&A expense was impacted by a $775 million legal settlement with Chugai Pharmaceutical Co. Ltd. 66 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Financial Review continued |
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(2022: charge of $216 million) offset by remeasurement of the defined benefit pension liability losses of $406 million (2022: gains of $1,118 million). EPS Reported EPS was $3.84 in the year (2022: $2.12). Core EPS was $7.26 (2022: $6.66). Restructuring Post Alexion Acquisition Group Review (PAAGR) In conjunction with the acquisition of Alexion in 2021, the enlarged Group initiated a comprehensive review, aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments. These activities are expected to be substantially complete by the end of 2026, with a number of planned activities having commenced in late 2021 and during 2022 and 2023. During 2023, the Group identified all remaining activities and finalised the scope of the programme. These additional activities, alongside updated estimates of the existing planned activities, have resulted in an increase to the expected one-time restructuring costs of $0.6 billion, of which an insignificant amount are non-cash costs, and an increase in capital investments of $0.7 billion. This includes the commencement of work on the planned upgrade of the Group’s Enterprise Resource Planning IT systems (Axial Project), which is expected to be substantially complete by the end of 2030, resulting in capital investments for software assets of $0.7 billion and one-time restructuring cash costs of $0.3 billion, over the full course of the project. Anticipated annual run-rate pre-tax benefits have increased by $0.5 billion, and are expected to be realised by the end of 2026. This excludes significant strategic and compliance-related benefits resulting from the Axial Project, as a result of transforming core enterprise-wide processes, harmonising systems architecture and enabling future digital capabilities. Consequently, the total programme activities are now anticipated to incur one-time restructuring costs of approximately $3.6 billion, of which approximately $2.5 billion are cash costs and $1.1 billion are non-cash costs, and capital investments of approximately $1.6 billion. EBITDA EBITDA increased by 47% (CER: 55%) to $13,580 million in the year (2022: $9,237 million) and was negatively impacted by the $114 million unwind of inventory fair value uplift recognised on the acquisition of Alexion. Taxation The Reported tax rate for the year was 14% and the Core tax rate in the year was 17% and included a favourable adjustment of $828 million to deferred taxes arising from a UK Group company undertaking a routine intragroup purchase of certain intellectual property which was offset by updates to tax liabilities following progress of reviews by tax authorities and administrative appeal processes, and derecognition of deferred tax assets following changes to forecast taxable income of specific subsidiaries. The income tax paid for the year was $2,366 million. This was $1,428 million higher than the Reported tax charge for the year, which benefited from a net deferred tax credit of $1,507 million (2022: $2,428 million), relating to the aforementioned $828 million deferred tax credit on the intragroup purchase of certain intellectual property, intangible amortisation and impairments, and other deferred tax items, partially offset by updates to estimates of prior period tax liabilities following progress of reviews by tax authorities and administrative appeal processes, and the timing differences for cash tax payments. Additional information on these items is contained in Note 4 to the Financial Statements from page 164. We pay corporate income taxes, customs duties, excise taxes, stamp duties, employment and many other business taxes in all jurisdictions in which we operate. We also collect and pay employee taxes and other indirect taxes such as value-added tax in these jurisdictions. Total comprehensive income Total comprehensive income increased by $4,279 million to a profit of $6,694 million in 2023. Other comprehensive income, net of tax was $733 million, an increase of $1,611 million. This income was primarily driven by foreign exchange arising on consolidation gains of $608 million (2022: losses of $1,446 million) and tax credits on items that will not be reclassified to profit or loss of $101 million Run-rate pre-tax benefits, before reinvestment, are now expected to be approximately $2.4 billion by the end of 2026. In line with established practice, restructuring costs will be excluded from our Core (non-GAAP) financial measures. During 2023, the Group has recorded restructuring charges of approximately $0.4 billion in relation to the PAAGR (2022: $0.7 billion), bringing the cumulative charges to date under this programme to $2.1 billion. Of these costs, $0.7 billion are non-cash costs arising primarily from impairments and accelerated depreciation on affected assets. As at 31 December 2023, the PAAGR has realised annual run-rate pre-tax benefits, before reinvestment, of $1.3 billion. Other programmes The Global Post Pandemic New Ways of Working programme that was initiated in 2020 in response to the changing business environment, accelerated by the COVID-19 pandemic, is now substantially complete and has delivered changes that reflect the increasing utilisation of digitisation and technology, as well as the new ways of working that reflect the size, nature and footprint of commercial teams, enabling functions, R&D and operations. Costs incurred in 2023 and 2022 were insignificant. Legacy programmes include: the 2016 plan to redeploy investment to key disease areas, particularly Oncology; the centralisation of our global R&D footprint into three strategic centres; transformation of the IT organisation and closure of a number of manufacturing facilities; and the transformation of SG&A functions (principally Finance and HR). Net costs for legacy programmes in 2023 were $92 million (2022: $45 million). The aggregate restructuring charge incurred in 2023 across all our restructuring programmes was $467 million (2022: $717 million). Final estimates for programme costs, benefits and headcount impact in all functions are subject to completion of the requisite consultation in the various areas. Our priority, as we undertake these restructuring initiatives, is to work with our affected employees on the proposed changes, acting in accordance with relevant local consultation requirements and employment law. For more information regarding the AstraZeneca tax policy, see our website, www.astrazeneca.com/policies. Reconciliation of Reported Profit before tax to EBITDA 2023 $m 2022 $m Actual growth % CER growth % Reported Profit before tax 6,899 2,501 >2x >2x Net finance expense 1,282 1,251 2 1 Share of after tax losses of joint ventures and associates 12 5 >2x >2x Depreciation, amortisation and impairment 5,387 5,480 (2) (1) EBITDA 13,580 9,237 47 55 AstraZeneca Annual Report & Form 20-F Information 2023 67 Strategic Report Corporate Governance Financial Statements Additional Information Financial Review |
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Bonds issued in 2023 and 20221 Repayment dates Face value of bond $m Net book value of bond at 31 December 2023 $m Bonds issued in 2023: 3.625% EUR bond 2027 791 829 4.875% USD bond 2028 1,100 1,095 4.9% USD bond 2030 650 645 3.75% EUR bond 2032 791 827 4.875% USD bond 2033 500 497 Total 2023 3,832 3,893 1 No bonds were issued in 2022. Cash flow and liquidity – for the year ended 31 December 2023 Net cash generated from operating activities was $10,345 million (2022: $9,808 million). This primarily reflects an underlying improvement in business performance. Net investment cash outflows were $4,638 million (2022: $2,906 million). Investment cash outflows for 2023 include: > Payments of contingent consideration from business combinations of $826 million (2022: $772 million). > $2,417 million (2022: $1,480 million) for the purchase of intangible assets, including $780 million for the CinCor asset acquisition, $300 million to acquire Pfizer’s preclinical rare disease gene therapy portfolio, regulatory milestones of $225 million and sales-related milestones of $100 million paid to Daiichi Sankyo in respect of Enhertu, and a $185 million upfront payment under the Eccogene licence agreement. Investment cash inflows include: > $291 million (2022: $447 million) from the sale of intangible assets and assets held for sale, mainly driven by $241 million from the disposal of US rights to Pulmicort Flexhaler to Cheplapharm. Net cash distributions to shareholders were $4,448 million (2022: $4,335 million), including proceeds from the issue of share capital of $33 million (2022: $29 million) less dividends paid of $4,481 million (2022: $4,364 million). Bonds In March 2023, AstraZeneca issued $3.8 billion of bonds. USD bonds with a notional face value of $2,250 million and EUR bonds with notional face value of €1,500 million were issued. No bonds were issued in 2022. In 2023, AstraZeneca repaid $2,000 million of floating rate bank loans in March 2023, which were due to mature in July 2023, a $1,400 million 0.3% callable bond, which matured in May 2023, $400 million of floating rate notes and an $850 million 3.5% callable bond, both of which matured in August 2023, and $287 million of 7% guaranteed debentures, which matured in November 2023. In 2022, AstraZeneca repaid a $250 million floating rate bond and a $1,000 million 2.375% fixed bond, both of which matured in June 2022. Summary cash flows 2023 $m 2022 $m 2021 $m Net debt brought forward at 1 January (22,923) (24,322) (12,110) Profit/(loss) before tax 6,899 2,501 (265) Sum of changes in interest, depreciation, amortisation, impairment and share of after tax losses on joint ventures and associates 6,681 6,736 7,851 Decrease in working capital and short-term provisions 300 3,757 2,021 Tax paid (2,366) (1,623) (1,743) Interest paid (1,081) (849) (721) Gains on disposal of intangible assets (251) (104) (513) Gains on disposal of joint ventures and associates – – (776) Fair value movements on contingent consideration arising from business combinations 549 82 14 Non-cash and other movements (386) (692) 95 Net cash available from operating activities 10,345 9,808 5,963 Purchase of intangibles (net of disposals) (2,126) (1,033) (522) Acquisition of subsidiaries, net of cash acquired (189) (48) (9,263) Net borrowings acquired from subsidiaries – – (2,779) Share-based payments attributable to business combinations (84) (215) (211) Payment of contingent consideration from business combinations (826) (772) (643) Other capital expenditure (net) (1,413) (838) (569) Investments (4,638) (2,906) (13,987) Dividends (4,481) (4,364) (3,856) Proceeds from the issue of share capital 33 29 29 Distributions (4,448) (4,335) (3,827) Repayment of obligations under leases (268) (244) (240) Payment of Acerta Pharma share purchase liability (867) (920) – Other movements 289 (4) (121) Net debt carried forward at 31 December (22,510) (22,923) (24,322) 68 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Financial Review continued |
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Net debt Net debt at 31 December 2023 was $22,510 million (2022: $22,923 million). At 31 December 2023, gross debt (interest-bearing loans and borrowings) was $28,622 million (2022: $29,232 million). Of the gross debt outstanding, $5,400 million is due within one year (2022: $5,542 million). At 31 December 2023, Cash and cash equivalents and Other investments totalled $5,962 million (2022: $6,405 million). The Group had committed bank facilities of $6,875 million available to manage liquidity at 31 December 2023. $2.0 billion of the commitments mature in February 2025. The maturity of the $4,875 million facilities was extended in February 2024 from April 2026 to April 2029. All facilities contain no financial covenants and were undrawn at 31 December 2023. The Group regularly monitors the credit standing of the banks providing the facilities and currently does not anticipate any issue with drawing on the committed facilities should this be necessary. Advances under these facilities currently bear an interest rate per annum based on SOFR (Secured Overnight Financing Rate) plus a margin. Financial position – 31 December 2023 All data in this section are on a Reported basis. Acquisitions In assessing whether an acquired set of assets and activities is a business or an asset, management will first elect whether to apply an optional concentration test to simplify the assessment. Where the concentration test is applied, the acquisition will be treated as the acquisition of an asset if substantially all of the fair value of the gross assets acquired (excluding cash and cash equivalents, deferred tax assets, and related goodwill) is concentrated in a single asset or group of similar identifiable assets. Where the concentration test is not applied, or is not met, a further assessment of whether the acquired set of assets and activities is a business will be performed. Acquisitions treated as Business combinations On 16 January 2023, AstraZeneca completed the acquisition of Neogene, a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts). The purchase price allocation exercise has completed, with the fair value of total consideration determined at $267 million. Intangible assets of $100 million and goodwill of $158 million were recognised in the acquisition balance sheet, as well as a cash outflow of $189 million net of cash acquired. Future contingent milestones-based For full details of acquisitions, see Note 27 to the Financial Statements from page 193. consideration and non-contingent consideration is payable to a maximum of $120 million. Neogene’s results have been consolidated into the Group’s results from 16 January 2023. On 16 November 2022, AstraZeneca completed the acquisition of 100% of the issued shares of LogicBio Therapeutics, Inc. (LogicBio), a clinical-stage genetic medicine company pioneering genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The total consideration was $72 million. $68 million cash was paid on the completion date, with $4 million of outstanding options, which will be settled in cash, recorded in current Trade and other payables. LogicBio’s results have been consolidated into the Group’s results from 16 November 2022. The acquisitions have been accounted for as business combinations using the acquisition method of accounting in accordance with IFRS 3 ‘Business Combinations’. Acquisitions treated as asset acquisitions On 24 February 2023, AstraZeneca completed the acquisition of 100% of the issued shares of CinCor, for consideration of $1,268 million, which included intangible assets acquired of $780 million, $424 million of cash and cash equivalents, and $75 million of marketable securities. Contingent consideration of up to $496 million could be paid on achievement of regulatory milestones, and those liabilities will be recorded when milestones are triggered, or performance conditions have been satisfied. In September 2023, AstraZeneca completed the definitive purchase and licence agreement for a portfolio of preclinical rare disease gene therapy programmes and enabling technologies from Pfizer. The agreement has a total consideration of up to $1 billion consisting of a $300 million upfront payment and $700 million of contingent consideration, plus tiered royalties on sales. Commitments and contingencies We have commitments and contingencies which are accounted for in line with Group Accounting Policies and are described in Note 30 to the Financial Statements from page 204. We also have taxation contingencies. These are described in this Financial Review, in the Taxation section in the Critical accounting policies and estimates section from page 152, and in Note 30 to the Financial Statements from page 204. Net debt reconciliation 2023 $m 2022 $m 2021 $m Cash and cash equivalents 5,840 6,166 6,329 Other investments1 122 239 69 Cash and investments 5,962 6,405 6,398 Overdraft and short-term borrowings (515) (350) (387) Lease liabilities (1,128) (953) (987) Current instalments of loans and borrowings (4,614) (4,964) (1,273) Loans due after one year (22,365) (22,965) (28,134) Loans and borrowings (28,622) (29,232) (30,781) Net derivative financial instruments 150 (96) 61 Net debt2 (22,510) (22,923) (24,322) 1 Other investments exclude non-current investments, which are included within the balance of $1,530 million (2022: $1,066 million) in the Consolidated Statement of Financial Position on page 149. 2 The equivalent GAAP measure to Net debt is ‘liabilities arising from financing activities’, which excludes the amounts for cash and overdrafts, other investments and non-financing derivatives shown above, and includes the Acerta Pharma share purchase liability of $833 million (2022: $1,646 million) presented in current Other payables. Payments due by period Less than 1 year $m 1-3 years $m 3-5 years $m Over 5 years $m Total 2023 $m Total 2022 $m Bank loans and other borrowings1 6,011 5,901 6,052 17,995 35,959 36,389 Lease liabilities 271 443 214 200 1,128 953 Contracted capital expenditure 288 101 – 979 1,368 502 Total 6,570 6,445 6,266 19,174 38,455 37,844 1 Bank loans and other borrowings include interest charges payable in the period, as detailed in Note 28 to the Financial Statements from page 195. AstraZeneca Annual Report & Form 20-F Information 2023 69 Strategic Report Corporate Governance Financial Statements Additional Information Financial Review |
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Off balance sheet transactions and commitments We have no off balance sheet arrangements and our derivative activities are non-speculative. The table on page 69 sets out our minimum contractual obligations at the year end. Research and development collaboration payments Details of future potential R&D collaboration payments are also included in Note 30 to the Financial Statements on page 204. As detailed in Note 30, payments to our partners may not become payable due to the inherent uncertainty in achieving the development and revenue milestones linked to the future payments. We may enter into further collaboration projects in the future that may include milestone payments and, as certain milestone payments fail to crystallise due to, for example, failure to obtain regulatory approval, unfavourable data from key studies, adverse reactions to the product candidate or indications of other safety concerns, they may be replaced by potential payments under new collaborations. Investments, divestments and capital expenditure We have completed more than 60 major or strategically important business development transactions over the past three years. The following strategic investment was made in 2023: Eccogene > In November 2023, AstraZeneca and Eccogene entered into an exclusive licence agreement for AZD5004, an investigational oral once-daily GLP-1RA for the treatment of obesity, type-2 diabetes and other cardiometabolic conditions. Preliminary results from the Phase I trial have shown a differentiating clinical profile for AZD5004, with good tolerability and encouraging glucose and body weight reduction across the dose levels tested compared to placebo. Under the terms of the agreement, Eccogene received an initial upfront payment of $185 million and up to an additional $1.8 billion in future clinical, regulatory, and commercial milestones and tiered royalties. AstraZeneca is granted exclusive global rights for the development and commercialisation of AZD5004 for any indication in all territories except China, where Eccogene has the right to co-develop and co-commercialise alongside AstraZeneca. In addition to the business development transactions detailed under Collaboration Revenue from page 65 of this Financial Review, the following significant collaborations remain in the development phase: Daiichi Sankyo > In July 2020, AstraZeneca entered into a new global development and commercialisation agreement with Daiichi Sankyo for Dato-DXd, its proprietary trophoblast cell-surface antigen 2 (TROP2)- directed ADC and potential new medicine for the treatment of multiple tumour types. AstraZeneca agreed to pay Daiichi Sankyo an upfront payment of $1 billion in staged payments: $350 million was due upon completion, with $325 million after 12 months and $325 million after 24 months from the effective date of the agreement. AstraZeneca also agreed to pay additional conditional amounts of up to $1 billion for the successful achievement of regulatory approvals and up to $4 billion for sales-related milestones. The transaction was accounted for as an intangible asset acquisition, recognised initially at the present value of non-contingent consideration, with any potential future milestone payments capitalised into the intangible asset as they are recognised. The companies will jointly develop and commercialise Dato-DXd worldwide, except in Japan where Daiichi Sankyo will retain exclusive rights. AstraZeneca and Daiichi Sankyo will share equally development and commercialisation expenses as well as profits relating to Dato-DXd worldwide, except for Japan where Daiichi Sankyo will be responsible for such costs and will pay AstraZeneca mid single-digit royalties. Daiichi Sankyo will record sales in the US, certain countries in Europe and certain other countries where Daiichi Sankyo has affiliates. Profits shared with AstraZeneca from those countries will be recorded as Alliance Revenue by AstraZeneca. AstraZeneca will record Product Sales in other countries worldwide, for which profits shared with Daiichi Sankyo will be recorded within Cost of sales. Daiichi Sankyo will manufacture and supply Dato-DXd. Innate Pharma > In April 2015, we entered into two oncology agreements with Innate Pharma: first, a licence which provides us with exclusive global rights to co-develop and commercialise IPH2201 in combination with Imfinzi; and, second, an option to license exclusive global rights to co-develop and commercialise IPH2201 in monotherapy and other combinations in certain treatment areas. We jointly fund Phase II studies with Innate Pharma and we lead the execution of these studies. In respect of these agreements, we made an initial payment to Innate Pharma of $250 million. The agreement also includes a Phase III initiation milestone of $100 million, as well as additional regulatory and sales-related milestones. We record all sales and pay Innate Pharma double-digit royalties on net sales. The arrangement includes the right for Innate Pharma to co-promote in Europe for an equal share of costs and income in the territory. > In October 2018, we exercised our option over IPH2201 and simultaneously entered into a further multi-element transaction with Innate Pharma. Under the agreement, we paid $50 million to collaborate on, and acquire an option to license, IPH5201, a potentially first-in-class anti-CD39 mAb. Additionally, we paid $20 million to acquire options over four future programmes currently being developed by Innate Pharma, and paid €62.6 million to acquire a 9.8% stake in Innate Pharma. The $100 million option fee and $50 million premium paid over market price for the investment in Innate Pharma have been capitalised as intangible assets. The payment for future programmes will be expensed as R&D expenditure over four years. We determine these business development transactions to be significant using a range of factors. We look at the specific circumstances of the individual arrangement and apply several quantitative and qualitative criteria. As we consider business development transactions to be an extension of our R&D strategy, the expected total value of development payments under the transaction and its proportion of our annual R&D spend, both of which are proxies for overall R&D effort and cost, are important elements of the determination of the significance. Other quantitative criteria we apply include, without limitation, expected levels of future sales, the possible value of milestone payments and the resources used for commercialisation activities (for example, the number of staff). Qualitative factors we consider include, without limitation, new market developments, new territories, new areas of research and strategic implications. 70 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Financial Review continued |
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For further information regarding Dividends, see Note 25 on page 192. For more information, see Our Strategy and Key Performance Indicators from page 12. Capitalisation and shareholder return Capitalisation The total number of shares in issue at 31 December 2023 was 1,550 million (2022: 1,550 million). Shareholders’ equity increased by $2,106 million to $39,143 million at the year end. Non-controlling interests were $23 million (2022: $21 million). Dividend and share repurchases The Board has recommended a second interim dividend of $1.97 (156.0 pence, 20.65 SEK) to be paid on 25 March 2024. This brings the full-year dividend to $2.90 (227.8 pence, 30.29 SEK). Against Reported EPS, the Group had a dividend cover ratio of 1.32:1 in 2023 (2022: 0.74:1). Against Core EPS, the Group had a dividend cover ratio of 2.50:1 in 2023 (2022: 2.32:1). This dividend is consistent with the progressive dividend policy, by which, the Board intends to maintain or grow the dividend each year. The Board regularly reviews its distribution policy and its overall financial strategy to continue to strike a balance between the interests of the business, our financial creditors and our shareholders. Having regard for business investment, funding the progressive dividend policy and meeting our debt service obligations, the Board currently believes it is appropriate to continue the suspension of the share repurchase programme which was announced in 2012. The Board reviews the level of distributable reserves of the Parent Company annually and aims to maintain distributable reserves that provide adequate cover for dividend payments. At 31 December 2023, the overwhelming majority of the Profit and loss account reserve of $17,640 million (2022: all of the Profit and loss account reserve of $7,458 million) was available for distribution, subject to filing these Financial Statements with Companies House. When making a distribution to shareholders, the Directors determine profits available for distribution by reference to guidance on realised and distributable profits under the Companies Act 2006 issued by the Institute of Chartered Accountants in England and Wales and the Institute of Chartered Accountants of Scotland in April 2017. The profits of the Parent Company have been received in the form of receivables due from subsidiaries. The availability of distributable reserves in the Parent Company is dependent on those receivables meeting the definition of qualifying consideration within the guidance, and in particular on the ability of subsidiaries to settle those receivables within a reasonable period of time. The Directors consider that, based on the nature of these receivables and the available cash resources of the Group and other accessible sources of funds, at 31 December 2023, the overwhelming majority (2022: all) of the Company’s profit and loss reserves were available for distribution. Future prospects As outlined earlier in this Annual Report, our strategic priorities support delivery of our Growth Through Innovation strategy and our Purpose: to push the boundaries of science to deliver life-changing medicines. In support of this, we made certain choices around our three strategic priorities: > Science and Innovation > Growth and Therapy Area Leadership > People and Sustainability. Full year 2024: additional commentary Total Revenue is expected to increase by a low double-digit to low teens percentage. Core EPS is expected to increase by a low double-digit to low teens percentage. Collaboration Revenue is expected to increase substantially, driven by success-based milestones and certain anticipated transactions. Other operating income is expected to decrease substantially (2023 included a $241m gain on the disposal of Pulmicort Flexhaler US rights, and a $712m one-time gain relating to updates to contractual arrangements with Sobi and Sanofi). The Core Tax rate is expected to be between 18-22%. The Group is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the Cautionary statement section regarding forward-looking statements on page 236. Currency impact If foreign exchange rates for February 2024 to December 2024 were to remain at the average rates seen in January 2024, it is anticipated that 2024 Total Revenue and Core EPS for the year would incur a low single-digit adverse impact versus the performance at CER. This commentary represents management’s current estimates and is subject to change. See the Cautionary statement regarding forward-looking statements on page 236. Financial risk management Financial risk management policies Insurance Our risk management processes are described in Risk Overview from page 54. These processes enable us to identify risks that can be partly or entirely mitigated through the use of insurance. We focus our insurance resources on the most critical areas, or where there is a legal requirement, and where we can get the best value for money through structured and traditional insurance. We purchase an external multi-line insurance programme to mitigate against significant financial loss arising from core business risks. Treasury The principal financial risks to which we are exposed are those arising from liquidity, interest rates, foreign currency and credit. We have a centralised treasury function to manage these risks in accordance with Board-approved policies. Note 28 to the Financial Statements from page 195 sets out the relevant policies and the way we manage these risks and our capital management objectives, as well as a sensitivity analysis of the Group’s exposure to exchange rate and interest rate movements. AstraZeneca Annual Report & Form 20-F Information 2023 71 Strategic Report Corporate Governance Financial Statements Additional Information Financial Review |
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Critical accounting policies and estimates The Consolidated Financial Statements have been prepared in accordance with UK-adopted IAS and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards. The Consolidated Financial Statements also comply fully with IFRS Accounting Standards as issued by the IASB and IAS as adopted by the EU. The accounting policies employed are set out in the Group Accounting Policies section from page 152. In applying these policies, we make estimates and assumptions that affect the Reported amounts of assets and liabilities and disclosure of contingent assets and liabilities. The actual outcome could differ from those estimates. Some of these policies require a high level of judgement because the areas are especially subjective or complex. We believe that the most critical accounting policies and significant areas of judgement and estimation are in the following areas and align with the accounting policies containing our key accounting judgements and significant accounting estimates as disclosed in the Financial Statements from page 152: > Revenue recognition – see Revenue Accounting Policy from page 152 and Note 1 on page 161 > Expensing of internal development expenses – see Research and Development Policy from page 154 > Impairment review of Intangible assets – see Note 10 on page 174 > Useful economic life of Intangible assets – see Research and Development from page 154 > Business combinations and Goodwill – see Business combinations and Goodwill Policy from page 156 and Note 27 from page 193 > Litigation liabilities – see Litigation and Environmental Liabilities within Note 30 on page 204 > Operating segments – see Note 6 on page 167 > Employee benefits – see Note 22 on page 190 > Taxation – see Tax in Note 30 from page 209. Revenue recognition Product Sales are recorded at the invoiced amount (excluding inter-company sales and value-added taxes), less movements in estimated accruals for rebates and chargebacks given to managed care and other customers, which are a particular feature in the US and are considered to be key estimates. It is the Group’s policy to offer a credit note for all returns and to destroy all returned stock in all markets. Cash discounts for prompt payments are also discounted from sales. Sales are recognised when the control of the goods has been transferred to a third party, which is usually when title passes to the customer, either on shipment or on the receipt of goods by the customer, depending on local trading terms. Rebates, chargebacks and returns in the US When invoicing Product Sales in the US, we estimate the rebates and chargebacks that we expect to pay, which are considered to be estimates. These rebates typically arise from sales contracts with third-party managed care organisations, hospitals, long-term care facilities, group purchasing organisations and various federal or state programmes (Medicaid contracts, supplemental rebates, etc.). They can be classified as follows: > Chargebacks, where we enter into arrangements under which certain parties, typically hospitals, long-term care facilities, group purchasing organisations, the Department of Veterans Affairs, Public Health Service Covered Entities, and the Department of Defense, are able to buy products from wholesalers at the lower prices we have contracted with them. The chargeback is the difference between the price we invoice to the wholesaler and the contracted price charged by the wholesaler to the other party. Chargebacks are credited directly to the wholesalers. > Regulatory, including Medicaid and other federal and state programmes, where we pay rebates based on the specific terms of agreements with the US Department of Health and Human Services and with individual states, which include product usage and information on best prices and average market prices benchmarks. > Contractual, under which entities such as third-party managed care organisations are entitled to rebates depending on specified performance provisions, which vary from contract to contract. The effects of these deductions on our US pharmaceuticals revenue and the movements on US pharmaceuticals revenue provisions are set out on this page. Accrual assumptions are built up on a product-by-product and customer-by-customer basis, taking into account specific contract provisions coupled with expected performance, and are then aggregated into a weighted average rebate accrual rate for each of our products. Accrual rates are reviewed and adjusted on an as needed basis. There may be further adjustments when actual rebates are invoiced based on utilisation information submitted to us (in the case of contractual rebates) and claims/invoices are received (in the case of regulatory rebates and chargebacks). We believe that we have made reasonable estimates for future rebates using a similar methodology to that of previous years. Inevitably, however, these estimates involve assumptions in respect of aggregate future sales levels, segment mix and customers’ contractual performance. Overall adjustments between gross and net US Product Sales amounted to $18,607 million in 2023 (2022: $14,846 million) with the increase driven by our US Product Sales. Cash discounts are offered to customers to encourage prompt payment. Accruals are calculated based on historical experience and are adjusted to reflect actual experience. Our revenue recognition policy is described within Group Accounting Policies from page 152. Industry practice in the US allows wholesalers and pharmacies to return unused stocks within six months of, and up to 12 months after, shelf-life expiry. The customer is credited for the returned product by the issuance of a credit note. Returned products are not exchanged for products from inventory and once a return claim has been determined to be valid and a credit note has been issued to the customer, the returned products are destroyed. At the point of sale in the US, we estimate the quantity and value of products which may ultimately be returned. Our returns accruals in the US are based on actual experience. Our estimate is based on the historical sales and returns information for established products together with market-related information, such as estimated shelf life, product recall, and estimated stock levels at wholesalers, which we receive via third-party information services. For newly launched products, we use rates based on our experience with similar products or a pre-determined percentage. Sarbanes-Oxley Act section 404 As a consequence of our Nasdaq listing, we are required to comply with those provisions of the Sarbanes-Oxley Act applicable to foreign issuers. Section 404 of the Sarbanes-Oxley Act requires companies annually to assess and make public statements about the quality and effectiveness of their internal control over financial reporting. As regards Sarbanes-Oxley Act section 404, our approach is based on the Committee of Sponsoring Organizations (COSO) 2013 framework. Our approach to the assessment has been to select key transaction and financial reporting processes in our largest operating units and a number of specialist areas (e.g. financial consolidation and reporting, treasury operations and taxation), so that, in aggregate, we have covered a significant proportion of the key lines in our Financial Statements. Each of these operating units and specialist areas has ensured that its relevant processes and controls are documented to appropriate standards, taking into account, in particular, the guidance provided by the US Securities and Exchange Commission (SEC). We have also reviewed the structure and operation of our ‘entity level’ control environment. This refers to the overarching control environment, including structure of reviews, checks and balances that are essential to the management of a well controlled business. 72 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Financial Review continued |
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Gross to Net Product Sales US pharmaceuticals 2023 $m 2022 $m 2021 $m Gross Product Sales 36,568 32,100 23,970 Chargebacks (3,075) (2,401) (2,095) Regulatory – Medicaid and state programmes (2,417) (1,879) (1,488) Contractual – Managed care and Medicare (11,035) (8,821) (7,121) Cash and other discounts (428) (359) (312) Customer returns (222) (132) (14) US branded pharmaceutical fee (124) (150) (57) Other (1,306) (1,104) (883) Net Product Sales 17,961 17,254 12,000 Movements in accruals US pharmaceuticals Brought forward at 1 January 2023 $m Provision for current year $m Adjustment in respect of prior years $m Returns and payments $m Carried forward at 31 December 2023 $m Chargebacks 233 2,743 (22) (2,709) 245 Regulatory – Medicaid and state programmes 771 2,468 (59) (2,194) 986 Contractual – Managed care and Medicare 2,426 11,166 (92) (10,373) 3,127 Cash and other discounts 27 428 – (424) 31 Customer returns 205 204 – (136) 273 US branded pharmaceutical fee 137 133 (5) (93) 172 Other 162 1,303 – (1,183) 282 Total 3,961 18,445 (178) (17,112) 5,116 Brought forward at 1 January 2022 $m Provision for current year $m Adjustment in respect of prior years $m Returns and payments $m Carried forward at 31 December 2022 $m Chargebacks 181 2,103 (13) (2,038) 233 Regulatory – Medicaid and state programmes 510 1,953 (79) (1,613) 771 Contractual – Managed care and Medicare 2,031 8,971 (141) (8,435) 2,426 Cash and other discounts 21 359 – (353) 27 Customer returns 196 112 – (103) 205 US branded pharmaceutical fee 79 138 16 (96) 137 Other 154 1,036 – (1,028) 162 Total 3,172 14,672 (217) (13,666) 3,961 Brought forward at 1 January 2021 $m Additions through business combinations $m Provision for current year $m Adjustment in respect of prior years $m Returns and payments $m Carried forward at 31 December 2021 $m Chargebacks 178 2 2,117 (21) (2,095) 181 Regulatory – Medicaid and state programmes 495 46 1,548 (50) (1,529) 510 Contractual – Managed care and Medicare 1,937 29 7,204 (83) (7,056) 2,031 Cash and other discounts 20 – 313 – (312) 21 Customer returns 253 18 13 – (88) 196 US branded pharmaceutical fee 115 – 77 (28) (85) 79 Other 128 4 882 – (860) 154 Total 3,126 99 12,154 (182) (12,025) 3,172 AstraZeneca Annual Report & Form 20-F Information 2023 73 Strategic Report Corporate Governance Financial Statements Additional Information Financial Review |
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We are committed to employing high ethical standards when carrying out all aspects of our business globally. Our Code of Ethics (the Code) is based on our Values, expected behaviours and key policy principles. More information on the Code can be found in the Business Review on page 49. AstraZeneca recognises patients as people first and puts them at the heart of what we do. Information on the importance of patients to the business can be found on page 84, with further information throughout the Business Review. The consideration and impact of the Group’s operations on the environment and how the Group has considered other factors, such as communities and suppliers, can be found throughout the People and Sustainability section from page 43. Details of how the Board operates and matters considered by the Board are set out in the Corporate Governance Report from page 75. Details on the Board and SET composition and gender diversity can be found on pages 78, 91, and 229. Examples of how Directors discharged their duties and considered stakeholders when making Principal Decisions during 2023 are set out from page 84. Principal Decisions are decisions and discussions which are material or strategic to the Group, but also those that are significant to any of our stakeholder groups. Section 172(1) statement The Board is required to promote the success of the Group for the shareholders and wider stakeholders who interact with and are impacted by our business. Throughout the year the Directors have had regard to the factors set out in section 172(1) (a)-(f), as well as other factors relevant to the decision being made. The Board acknowledges that every decision made will not necessarily result in a positive outcome for all stakeholders. By considering our Purpose and Values, together with our strategic priorities, the Board aims to ensure that the decisions made are consistent and intended to promote the Company’s long-term success. The Group engaged with key stakeholders throughout the year to understand the issues and factors that are significant for these stakeholders, and a number of actions were taken as a result of this engagement. The interaction, and impact of these interactions, are set out in the Connecting with our stakeholders section on pages 84 to 86 and throughout the Strategic Report. We are committed to being a great place to work for the global workforce. Details on engagement with employees can be found on pages 43 to 45 of the Business Review, from page 84 of the Corporate Governance Report, page 97 in the Audit Committee Report and page 121 to 122 of the Remuneration Committee Report. Strategic Report The following sections make up the Strategic Report, which has been prepared in accordance with the requirements of the Companies Act 2006: > Chair’s Statement > Chief Executive Officer’s Review > AstraZeneca at a Glance > What science can do: artificial intelligence > Healthcare in a Changing World > Our Purpose, Values and Business Model > Our Strategy and Key Performance Indicators > Therapy Area Review > Business Review > EU Taxonomy Disclosure > Task Force on Climate-related Financial Disclosures Summary Statement > Risk Overview > Financial Review and has been approved and signed on behalf of the Board. A C N Kemp Company Secretary 8 February 2024 74 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Financial Review continued |
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Contents Chair’s Introduction 76 Corporate Governance Overview 77 Board of Directors 78 Senior Executive Team (SET) 80 Corporate Governance Report 81 Nomination and Governance Committee Report 90 Science Committee Report 92 Sustainability Committee Report 93 Audit Committee Report 94 Directors’ Remuneration Report 102 Remuneration Policy 127 Corporate Governance AstraZeneca Annual Report & Form 20-F Information 2023 75 Strategic Report Corporate Governance Financial Statements Additional Information |
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It’s a pleasure to be introducing AstraZeneca’s Corporate Governance Report for the first time as Chair. Our Strategic Report provides an update on how AstraZeneca is delivering its Growth Through Innovation strategy, including how we attract, retain and develop talented people as our employees. This Report reviews AstraZeneca’s governance and the work of the Board’s Committees. I would like to begin by thanking my fellow Directors for the support they have given me in my first year as Chair and welcoming Anna Manz who became a Non-Executive Director and member of the Audit Committee in September. She brings extensive cross-sector business skills and knowledge to the Board, having held international roles in North America and Asia Pacific and served as an executive and non-executive in large, listed companies. I also want to recognise the role that all the Directors play in carrying out their responsibilities as members of our Board Committees. I am particularly grateful to the chairs of the Committees for the diligent and committed way in which they carry out their duties, especially Philip Broadley who, in addition to his important role as Chair of the Audit Committee, performs the role of our senior independent Non-Executive Director. Finally, I would like to thank Euan Ashley who assumed the role as Chair of the Science Committee during the year. I would urge readers to read the reports from the individual Committee Chairs that give an indication of the depth and breadth of their work on behalf of shareholders. This Governance Report also reports on how we consider the interests of our stakeholders and engage with them in determining our strategy. The Audit Committee has a key role in monitoring the integrity of our financial reporting and management of risk. Cyber risk and cyber security have been, and continue to be, a particular focus of their activity in recent years. During 2023, the Audit Committee as well as the Sustainability Committee, had an important role considering the potential and enacted regulations by the US, EU and UK on sustainability reporting, as well as the ongoing assessments of double materiality topics for AstraZeneca under EU regulations, to ensure that we are prepared for new sustainability reporting regulations which you will see reflected in AstraZeneca’s 2024 Annual Report. The Sustainability Committee also reviewed progress against our Ambition Zero Carbon targets and programmes. Euan and the Science Committee had a particularly busy year in reviewing our R&D strategy and science capabilities as well as studying the scientific case for the numerous acquisitions and licensing opportunities that were undertaken during 2023. A particular responsibility of the Remuneration Committee in 2023 was to review and update our Remuneration Policy, which can be found from page 127 and will be proposed for approval by our shareholders at the AGM in April. In doing so, we are introducing some changes the Board believes are in the best interests of the Group and its shareholders, and which will incentivise management to deliver our ambitious strategy. Good governance underpins any successful enterprise and I look forward to continuing my role in ensuring that AstraZeneca’s future growth and prospects are accompanied and enabled by good governance overseen by a skilled and diverse Board of Directors. Michel Demaré Chair “Good governance underpins any successful enterprise...” “This Report reviews AstraZeneca’s governance and the work of the Board’s Committees.” 76 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Chair’s Introduction |
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Governance structure Attendance in 2023 The Directors are collectively responsible for the success of the Group. The Board maintains and periodically reviews a list of matters that can only be approved by the Board. Matters that have not been expressly reserved to the Board in this way are delegated to the CEO or one of the Board’s five Committees. The diagram below illustrates this governance structure. The Board’s responsibilities include setting our strategy and policies, overseeing risk and corporate governance, and monitoring progress towards meeting our objectives and annual plans. It is accountable to our shareholders for the proper conduct of the business and our long-term success, and seeks to represent the interests of all stakeholders. The CEO, CFO and SET take the lead in developing our strategy; proposals are reviewed and constructively challenged by the Board, before the strategy is approved. Audit Committee Report from page 94 Science Committee Report from page 92 Nomination and Governance Committee Report from page 90 Remuneration Committee Report from page 102 Sustainability Committee Report from page 93 The Board has delegated some of its powers to the CEO and operates with the assistance of five Committees: Board Corporate Governance Report from page 77 Board Committee membership and meeting attendance in 2023 Board or Committee Chair Director Appointment date1 Board2,8 Audit Committee Remuneration Committee Nomination and Governance Committee Science Committee Sustainability Committee Non-Executive Chair and Executive Directors Michel Demaré3 01/09/2019 8/8 4/4 6/6 6/6 Leif Johansson4 26/04/2012 2/2 1/1 4/4 Pascal Soriot 01/10/2012 8/8 Aradhana Sarin 01/08/2021 8/8 Non-Executive Directors Euan Ashley5,8 01/10/2020 7/8 5/6 9/9 Philip Broadley 27/04/2017 8/8 7/7 6/6 6/6 Deborah DiSanzo8 01/12/2017 7/8 7/7 Diana Layfield8 01/11/2020 7/8 9/9 Sheri McCoy8 01/10/2017 7/8 6/7 6/6 6/6 2/2 Tony Mok8 01/01/2019 7/8 9/9 Nazneen Rahman6 01/06/2017 8/8 3/4 6/6 9/9 2/2 Andreas Rummelt 01/08/2021 8/8 2/2 Marcus Wallenberg8 05/04/1999 7/8 5/9 2/2 Anna Manz7 01/09/2023 4/4 2/2 1 Date of first appointment or election to the Board. 2 Four Board meetings in 2023 were held by videoconference and four were held in person at the Company’s sites in London, UK; Tokyo, Japan; and Gaithersburg, MD, US. 3 Michel Demaré succeeded Leif Johansson as Non-Executive Chair of the Board and Chair of the Nomination and Governance Committee on 27 April 2023. 4 Leif Johansson retired as Non-Executive Chair of the Board and as a Director on 27 April 2023. 5 Euan Ashley succeeded Nazneen Rahman as Chair of the Science Committee and became a member of the Nomination and Governance Committee on 1 June 2023. 6 Nazneen Rahman became a member of the Remuneration Committee on 1 May 2023. 7 Anna Manz joined the Board and the Audit Committee on 1 September 2023. 8 One ad hoc videoconference Board meeting in 2023 was called at short notice. Due to this and the timing of the meeting, several Board members’ prior commitments or their time zone prevented them from attending. They received and reviewed the papers for the meeting and their comments were relayed to the Chair ahead of the meeting. AstraZeneca Annual Report & Form 20-F Information 2023 77 Strategic Report Corporate Governance Financial Statements Additional Information Corporate Governance Overview Corporate Governance Overview |
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0-3 years 2 Andreas Rummelt Anna Manz 6 years plus 5 Marcus Wallenberg Philip Broadley Deborah DiSanzo Sheri McCoy Nazneen Rahman 3-6 years 4 Euan Ashley Michel Demaré Tony Mok Diana Layfield Men 7 Women 6 British 5 American 3 Swedish 1 Belgian 1 Canadian 1 French 1 German 1 Gender split of Directors Directors’ nationalities Length of tenure of Non-Executive Directors Board composition as at 31 December 2023 Michel Demaré NG R Non-Executive Chair of the Board Skills and experience: Michel was previously Vice-Chairman of UBS Group AG (2010-2019), Chairman of Syngenta and Syngenta Foundation for Sustainable Agriculture (2013-2017) and Chairman of SwissHoldings (2013-2015). Between 2005 and 2013, Michel was CFO of ABB Ltd and interim CEO during 2008. He joined ABB from Baxter International Inc., where he was CFO Europe from 2002 to 2005. Prior to that, he spent 18 years at The Dow Chemical Company, serving as CFO of Dow’s Global Polyolefins and Elastomers division between 1997 and 2002. Other appointments: Michel is a Non-Executive Director of Vodafone Group plc and Louis Dreyfus Int’l Holding BV and Chairman of IMD Business School. Pascal Soriot Executive Director and CEO Skills and experience: Pascal brings a passion for science and medicine, significant experience in established and emerging markets, strength of strategic thinking and execution, a successful track record of managing change and executing strategy, and the ability to lead a diverse organisation. He served as COO of Roche’s pharmaceuticals division and, prior to that, as CEO of Genentech. Pascal has worked in senior management roles in several major companies around the world. He is a Doctor of Veterinary Medicine and holds an MBA from HEC Paris. In 2022, Pascal received a knighthood for services to life sciences and leadership in the global response to the COVID-19 pandemic. Other appointments: Pascal is on the Board of Sustainable Markets Initiative Limited. Aradhana Sarin Executive Director and CFO Skills and experience: Before joining AstraZeneca, Aradhana was CFO for Alexion, responsible for driving strategic growth, financial performance and business development. She brings operational experience in biopharma, plus more than 20 years of professional experience at global financial institutions and extensive knowledge of global healthcare systems. This includes tenures at Citi Global Banking, UBS, and JP Morgan. Aradhana trained as a medical doctor in India and spent two years practising in both India and Africa. She completed her medical training at the University of Delhi and received her MBA from Stanford Business School. Other appointments: Aradhana is on the Board of Governors of the American Red Cross and an independent director of Anheuser-Busch InBev. Philip Broadley A NG R Senior independent Non-Executive Director Skills and experience: Philip was previously Group Finance Director of Prudential and Old Mutual. He has served as chairman of the 100 Group of Finance Directors and as a member of the Takeover Panel. He is a Fellow of the Institute of Chartered Accountants in England and Wales. Philip graduated in Philosophy, Politics and Economics from the University of Oxford, where he is a St Edmund Fellow, and holds an MSc in Behavioural Science from LSE. Other appointments: Philip serves as a Non-Executive Director of Legal & General and Non-Executive Director of Lancashire Holdings where he will assume the role of Chair following its 2024 AGM. He is Treasurer of the London Library and Chairman of the Board of Governors of Eastbourne College. Committee membership key Committee Chair NG Nomination and Governance A Audit Sc Science R Remuneration Su Sustainability Euan Ashley NG Sc Non-Executive Director Skills and experience: Euan studied physiology and medicine at Glasgow University, trained as a junior doctor at Oxford University Hospitals NHS Trust, and gained a DPhil in cardiovascular cellular biology and molecular genetics at the University of Oxford. In 2002, Euan moved to Stanford University, where his research focuses on genetic mechanisms of cardiovascular health and disease. His laboratory leverages AI and digital health tools, alongside biotechnology and technology partners, to advance translational and clinical research. Euan’s awards include recognition from the White House for contributions to personalised medicine and the American Heart Association’s Medal of Honor for precision medicine. Other appointments: Euan is Associate Dean and Professor of Biomedical Data Science and Professor of Cardiovascular Medicine and Genetics at Stanford University. Deborah DiSanzo A Non-Executive Director Skills and experience: Deborah has more than 30 years’ experience in healthcare and technology. She is currently President of Best Buy Health, which provides digital health solutions in active aging, virtual care and consumer health. Deborah teaches Artificial Intelligence in Health at the Harvard TH Chan School of Public Health. Until December 2018, she served as General Manager of IBM Watson Health. Prior to IBM, Deborah held multiple senior executive positions at Philips Healthcare where she also was Chief Executive Officer. Deborah has been honoured by multiple organisations as a top health influencer. She holds an MBA from Babson College and is a Harvard University Advanced Leadership Initiative 2019 Fellow. Other appointments: Deborah is President of Best Buy Health. 78 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Board of Directors as at 31 December 2023 |
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Nazneen Rahman Sc Su NG R Non-Executive Director Skills and experience: Nazneen has significant experience in rare disease and cancer genomics and sustainable healthcare. She qualified in medicine from Oxford University, is an accredited specialist in medical genetics and has a PhD in molecular genetics. Nazneen was Professor of Genetics at the Institute of Cancer Research, Head of Cancer Genetics at the Royal Marsden NHS Foundation Trust, and founder and Director of the TGLclinical Genetic Testing Laboratory until 2018. In 2020, Nazneen founded YewMaker to build science-based sustainable healthcare solutions. Nazneen has a strong commitment to open science and has garnered numerous awards, including a CBE in recognition of her contribution to medical sciences. Other appointments: Nazneen is CEO of YewMaker and Director of the Sustainable Medicines Partnership. Andreas Rummelt Su Non-Executive Director Skills and experience: Andreas joined the Board following the acquisition of Alexion, where he had been a Director since 2010. Previously he was at Novartis Pharma AG. where he served on the Executive Committee from 2006 to 2010. He had been Group Head of Technical Operations and Quality from 2009 until 2010. He was Global CEO of Sandoz, the Generics Division of Novartis from 2004 to 2008, having originally joined in 1985. Andreas earned his PhD in pharmaceutical sciences from the University of Erlangen-Nuremberg and received his executive training in general management and leadership from IMD in Lausanne, INSEAD in Fontainebleau and Harvard Business School. Other appointments: Andreas is Chairman and Partner of InterPharmaLink AG since 2011 and a director of various privately-held biotech and pharmaceutical companies. Sheri McCoy R A NG Su Non-Executive Director Skills and experience: Until February 2018, Sheri was CEO and a Director of Avon Products, Inc. and, prior to that, had a 30-year career at Johnson & Johnson (J&J), latterly serving as Vice-Chairman of the Executive Committee, responsible for the Pharmaceuticals and Consumer business segments. Sheri joined J&J as an R&D scientist and subsequently managed businesses in every major product sector. She holds a BSc in Textile Chemistry from the University of Massachusetts Dartmouth, an MSc in Chemical Engineering from Princeton University and an MBA from Rutgers University. Other appointments: Sheri serves on the boards of Stryker, Kimberly-Clark, and Sail Biomedicines. She is also an industrial adviser for EQT, and in connection serves on the boards of Galderma, Parexel and is Chair of Dechra. Marcus Wallenberg Sc Su Non-Executive Director Skills and experience: Marcus has international business experience across various industry sectors, including the pharmaceutical industry from his directorship with Astra prior to 1999. Other appointments: Marcus is Chair of Skandinaviska Enskilda Banken AB, Saab AB and FAM AB. He is Vice-Chair of Investor AB and Vice-Chair of EQT AB. Marcus is also Chair of the Royal Swedish Academy of Engineering Sciences and a Board member of the Knut and Alice Wallenberg Foundation. Tony Mok Sc Non-Executive Director Skills and experience: Tony is the Li Shu Fan Medical Foundation endowed Professor and Chairman of the Department of Clinical Oncology at the Chinese University of Hong Kong. His work includes multiple aspects of lung cancer research, including biomarker and molecular targeted therapy in lung cancer. Tony is the Past President of the International Association for the Study of Lung Cancer and a past Board member of the American Society of Clinical Oncology. He has achieved numerous awards including the European Society for Medical Oncology (ESMO) Lifetime Achievement Award, Giant of Cancer Care, and the Bronze Bauhinia Star. Other appointments: Tony is Non-Executive Director of HUTCHMED (China) Limited, member of the Scientific Advisory Board of Prenetics Global Limited and serves on the board of Insighta. Leif Johansson NG R Formerly Non-Executive Chair of the Board (retired in April 2023) Anna Manz A Non-Executive Director Skills and experience: Anna joined London Stock Exchange in 2020 as CFO, ahead of its acquisition of Refinitiv. Prior to this, she was an Executive Director and the CFO of Johnson Matthey Plc and, before that, spent 17 years at Diageo plc in a number of senior finance roles. She brings extensive expertise in accounting, corporate finance and M&A, as well as experience of business diversification, transformation and strategy. Anna was previously a Non-Executive Director of ITV plc and served on its Audit Committee and Remuneration Committee during most of that period. Other appointments: Anna will step down from her role at London Stock Exchange in 2024 to join Nestlé S.A. as CFO and a member of Nestlé’s Executive Board. Diana Layfield Sc Non-Executive Director Skills and experience: Diana has broad global business experience including in the pharmaceutical and biotech sector. She has held senior leadership roles at Standard Chartered Bank, as the CEO of a start-up technology company, and in Healthcare and Life Sciences at McKinsey & Co. Until December 2020, Diana was a Non-Executive Director of Aggreko plc. She has a BA from Oxford University and an MA in Public Administration and International Economics from Harvard University. Other appointments: Diana is General Manager, International Search at Google and was also President, EMEA Partnerships and Vice-President, ‘Next Billion Users’. She is the Chair of British International Investment plc and a Council Member of the London School of Hygiene & Tropical Medicine. Board of Directors AstraZeneca Annual Report & Form 20-F Information 2023 79 Strategic Report Corporate Governance Financial Statements Additional Information |
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The Senior Executive Team, or SET, is the body through which the CEO exercises the authority delegated to him by the Board. The CEO leads the SET and has executive responsibility for the management, development and performance of the business. The CEO, CFO and SET also take the lead in developing the strategy for review, constructive challenge and approval by the Board as part of the annual strategy review process. SET members who sit on the Board: > Pascal Soriot CEO > Aradhana Sarin CFO Sharon Barr Executive Vice-President, BioPharmaceuticals R&D Sharon joined in 2021 and is responsible for discovery through to late-stage development across CVRM and Respiratory & Immunology. Previously, Sharon was SVP, Head of Research and Product Development of Alexion. Sharon undertook a PhD in molecular biology from NYU and a postdoctoral fellowship at Stanford University. Ruud Dobber Executive Vice-President, BioPharmaceuticals Business Unit Ruud is responsible for the CVRM, Respiratory & Immunology, neuroscience and infection business units. Ruud joined AstraZeneca in 1997 and held various executive roles externally before this. Ruud was previously a research scientist in immunology and ageing, holding a doctorate in immunology from the University of Leiden. Jeff Pott Chief Human Resources Officer, Chief Compliance Officer and General Counsel Jeff is responsible for all aspects of AstraZeneca’s People strategy and leads our HR, Compliance, and Legal and IP functions. Jeff joined in 1995, before which he specialised in pharmaceutical product liability and antitrust litigation. He holds a Bachelor’s degree from Wheaton College and a Juris Doctor Degree from Villanova University. David Fredrickson Executive Vice-President, Oncology Business Unit Dave is responsible for driving growth and maximising the commercial performance of the AstraZeneca global Oncology portfolio. Before joining AstraZeneca, Dave worked at Roche/ Genentech, where he served in several functions and leadership positions. Dave is a graduate of Georgetown University in Washington DC. Iskra Reic Executive Vice-President, Vaccines & Immune Therapies Iskra is Head of the Vaccines & Immune Therapies business unit. Established in 2021, during AstraZeneca’s industry-leading response to the COVID-19 pandemic, Vaccines & Immune Therapies is focused on developing transformative vaccines and immune therapies to prevent infectious diseases globally. Iskra trained as a doctor of Dental Surgery at the Medical University of Zagreb and has an MBA from the IEDC-Bled School of Management. Pam Cheng Executive Vice-President, Global Operations, IT and Chief Sustainability Officer Pam joined in 2015, after 18 years with Merck/MSD in Global Manufacturing. Pam has also worked for Universal Oil Products, Union Carbide Corporation and GAF Chemicals. She holds Bachelor’s and Master’s degrees in chemical engineering from Stevens Institute of Technology and an MBA from Pace University. Susan Galbraith Executive Vice-President, Oncology R&D Susan has global accountability for Oncology R&D from discovery through to late-stage development. Susan joined AstraZeneca in 2010, having previously worked at BMS. She graduated in medicine from Cambridge University, has a PhD from the University of London and qualified as a Clinical Oncologist in 2001. Leon Wang Executive Vice-President, International and China President Leon is responsible for driving sustainable growth across the International region, including China. China is now AstraZeneca’s third-largest market, and AstraZeneca is its largest pharmaceutical company. Leon holds an EMBA from China Europe International Business School, and a BA from Shanghai International Studies University. Marc Dunoyer CEO, Alexion and Chief Strategy Officer, AstraZeneca Marc served as AstraZeneca’s Chief Financial Officer until 2021. Previously, he served as Global Head of Rare Diseases at GSK and (concurrently) Chairman, GSK Japan. He holds an MBA from HEC Paris and a Bachelor of Law degree from Paris University. Menelas (Mene) Pangalos Executive Vice-President (formerly Executive Vice-President, BioPharmaceuticals R&D and SET member 2013-2023) Mene will retire from AstraZeneca in early 2024. Katarina Ageborg Formerly Executive Vice-President, Sustainability and Chief Compliance Officer; President AstraZeneca AB Sweden Katarina retired in January 2023. Further information about SET members is available on our website, www.astrazeneca.com. See Board of Directors biographies from page 78. 80 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Senior Executive Team (SET) as at 31 December 2023 |
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Statement of compliance Our statement of compliance below describes how we applied the principles in the 2018 UK Corporate Governance Code (the Code) for the year ended 31 December 2023. A copy of the Code can be found on the Financial Reporting Council’s (FRC) website, www.frc.org.uk. Throughout the accounting period we have complied with all the provisions of the Code other than provision 21, which relates to the Board’s annual performance evaluation. Our approach to the Board’s performance evaluation for 2023 is described on page 89. Additional information for Swedish shareholders The Company is incorporated under the laws of England and Wales and its shares are listed on the London Stock Exchange, Nasdaq Stockholm and the Nasdaq Global Select Market in the US. In accordance with the Company’s listing on the London Stock Exchange, it applies the principles set out in the Code. As a result of its listing on Nasdaq Stockholm and in accordance with Swedish regulations, the Company is required to disclose the material ways in which its corporate governance practices differ from those applied by Swedish companies following the Swedish Corporate Governance Code (the Swedish Code). The Company has made available on its website www.astrazeneca.com/investor-relations/ corporate-governance.html a summary of the material ways in which the corporate governance practices applied by the Company differ from the principles of the Swedish Code. In addition, as required by Swedish regulations, the Company has also made available on its website a general description of the main differences in minority shareholders’ rights between the Company’s place of domicile (the UK) and Sweden, where the Company’s shares are also admitted to trading. 1. Board leadership and Company purpose A. Board’s role The Board’s role is to promote the long-term sustainable success of the Company. The Directors’ diverse range of skills, experience and industry knowledge, and ability to exercise independent and objective judgement, help the Board to operate effectively in its oversight of delivery of the Group’s strategy, generation of shareholder value and contributions to wider society. The Board’s effective operation is underpinned by a sound governance structure, described on page 77. Through a programme of regular Board and Board Committee meetings, Directors receive information on AstraZeneca’s financial performance, the R&D pipeline and critical business issues. The Board is accountable to our shareholders for the proper conduct of the business and our long-term success and seeks to represent the interests of all stakeholders. B. Purpose, culture and strategy The Board believes that our Purpose, to push the boundaries of science to deliver life-changing medicines, positions AstraZeneca for long-term sustainable success. Our Code of Ethics and our Values underpin the behaviours that support our culture. The Board is responsible for setting our strategy and policies, overseeing risk and corporate governance, and monitoring progress towards meeting our objectives and annual plans. The Board conducts an annual review of the Group’s overall strategy. C. Resources and controls The Board ensures that the necessary resources are in place to help the Company meet its objectives and measure its performance against them. The Group Internal Audit and Compliance functions provide quarterly reports to the Audit Committee on their activities and annual reviews of key themes, processes and systems (including arrangements for whistleblowing). The Board has full oversight of these matters by way of the Audit Committee Chair’s reports to the Board after each Committee meeting. Board members are also able to access the information provided to the Audit Committee. The Board has a formal system in place for Directors to declare a conflict, or potential conflict, of interest. D. Stakeholder engagement The Board aims to ensure a good dialogue is maintained with shareholders, so that their views are understood and considered. The Board also engages with and considers wider stakeholder groups, including the workforce, in its decision making. E. Workforce policies Based on our Values, expected behaviours and key policy principles, the Code of Ethics empowers employees to make decisions in the best interests of the Group, the Company, society and the patients we serve. It is applicable to the Group worldwide, including the Board. 2. Division of responsibilities F. Chair of the Board Michel Demaré, our Non-Executive Chair, is responsible for the Board’s overall effectiveness in directing the Company. Mr Demaré was first appointed to the Board in 2019 and was considered to be independent on his appointment as Chair in April 2023. G. Board composition, independence and division of responsibilities The composition of the Board is set out on pages 78 and 79. The majority of the Board consists of independent Non-Executive Directors. Directors’ independence is considered annually by the Board, as described on page 83. The Directors are collectively responsible for the success of the Group. The roles of the Board, Board Committees, Chair, senior independent Non-Executive Director and CEO are documented, as are the Board’s reserved powers and delegated authorities. The Board’s responsibilities and the governance structure by which it delegates authority are outlined in the Corporate Governance Overview on page 77. The Board maintains a list of matters that are reserved to, and can only be approved by, the Board. These include: the appointment, termination and remuneration of any Director; approval of the annual budget; approval of any item of fixed capital expenditure or any proposal for the acquisition or disposal of an investment or business which exceeds $300 million; the raising of capital or loans by the Company (subject to certain exceptions); the giving of any guarantee in respect of any borrowing of the Company; and allotting shares of the Company. Matters that have not been expressly reserved to the Board are delegated to the Committees of the Board or the CEO. H. Non-Executive Directors’ role and time commitment The Non-Executive Directors exercise objective judgement in respect of Board decisions, providing scrutiny and challenge and holding management to account. Non-Executive Directors offer strategic guidance and specialist advice based on their breadth of experience and knowledge. The Non-Executive Directors regularly meet without the Executive Directors or other management present. Corporate Governance Report / Compliance with the UK Corporate Governance Code For more information on: Our Purpose, our Values and our Business Model, see page 10. Our Code of Ethics, see page 49. Our resources and controls, see the Audit Committee Report from page 94. Conflicts of interest, see page 225. Stakeholder engagement, see pages 84 to 86 and throughout the Strategic Report. Our section 172(1) statement is set out on page 74. The Board’s performance evaluation, see page 89. AstraZeneca Annual Report & Form 20-F Information 2023 81 Strategic Report Corporate Governance Financial Statements Additional Information Corporate Governance Report Compliance with the UK Corporate Governance Code |
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The Company’s senior independent Non-Executive Director serves as a sounding board for the Chair and as an intermediary for the other Directors when necessary. The senior independent Non-Executive Director is also available to shareholders if they have concerns that contact through the normal channels of Chair or Executive Directors has failed to resolve, or for which such contact is inappropriate. Philip Broadley was appointed senior independent Non-Executive Director on 1 March 2021. As well as their work in relation to formal Board and Board Committee meetings, Non-Executive Directors commit time throughout the year to meetings and telephone calls with various levels of executive management and other key stakeholders, visits to AstraZeneca’s sites throughout the world (whether in person or virtually) and, for new Directors, induction sessions and site visits. The Chair and individual Board members ensure that Board members’ time commitment to the Company is sufficient to fulfil their duties as Directors and fully discharge their obligations to shareholders, particularly in the case of the Chairs of Board Committees. For the Chair of the Board, generally, as a basic commitment, it is expected that they would need to devote about 40% of their time or the equivalent of not less than 90 days per annum in the fulfilment of their duties. When contemplating taking up additional appointments, Non-Executive Directors consult the Chair to ensure thought is given to any potential impact on their time commitment to AstraZeneca. Careful consideration is given to the nature of the potential appointment and the type of company involved (for example, whether the company is a public listed company or privately held), to help assess the likely time requirement. For significant additional appointments, the full Board would typically be involved in this process. In 2023, Aradhana Sarin was appointed as an independent director of Anheuser-Busch InBev and Philip Broadley was appointed as a Non-Executive Director and Chair-designate of Lancashire Holdings Limited. These appointments were considered and approved by the Board on the basis that they would not prevent or reduce the ability of either to perform their roles for AstraZeneca to the required standard. The performance of the Non-Executive Directors is assessed annually as part of the Board’s performance evaluation, as described on page 89. Subject to specific Board approval, Executive Directors and SET members may accept external appointments as non-executive directors of other companies and retain any related fees paid to them, provided that such appointments are not considered by the Board to prevent or reduce the ability of the executive to perform his or her role within the Group to the required standard. I. Company Secretary The Company Secretary is responsible to the Chair for ensuring that all Board and Board Committee meetings are properly conducted, that the Directors receive appropriate information prior to meetings to enable them to make an effective contribution and that governance requirements are considered and implemented. The 2023 Board performance evaluation set out on page 89 provides details of the effective operation of the Board. 3. Composition, succession and evaluation J. Appointments and succession planning The Nomination and Governance Committee and, where appropriate, the full Board, regularly review the composition of the Board and the status of succession to both SET- and Board-level positions. Directors have regular contact with, and access to, succession candidates for SET positions. The Committee also recognises the importance of diversity when considering potential appointments. There is a formal, rigorous and transparent procedure for appointments to the Board. The Nomination and Governance Committee Report details changes in Board composition during the year, and the appointment and induction processes, from page 90. In accordance with Article 66 of the Articles of Association of the Company (the Articles), all Directors retire at each AGM and may offer themselves for re-election by shareholders. The Notice of AGM will give details of those Directors seeking election or re-election. K. Skills, experience and knowledge When the Nomination and Governance Committee reviews the composition of the Board and its Committees, it uses a matrix that records the skills and experience of current Board members and compares this with the skills and experience it believes are appropriate to the Company’s overall business and strategic needs, both now and in the future. The Committee is also mindful of Directors’ lengths of tenure and the need to refresh Board membership over time. L. Board evaluation In 2023, the Board undertook an internal Board performance evaluation. More information on the evaluation process, including the results and actions taken, can be found on page 89. 4. Audit, risk and internal control M. Internal and external audit The Audit Committee is responsible for reviewing the relationship and independence of our external auditor, PricewaterhouseCoopers LLP (PwC). The Committee maintains a policy for the pre-approval of all audit services and audit-related services undertaken by the external auditor, the principal purpose of which is to ensure that the independence of the external auditor is not impaired. A tender of audit services will be conducted in 2024 with any change taking effect from 2027. More information can be found on page 101. The Audit Committee also reviews the independence and effectiveness of Group Internal Audit. N. Fair, balanced and understandable assessment The Board considers this Annual Report, taken as a whole, to be fair, balanced and understandable, and provides the information necessary for shareholders to assess AstraZeneca’s position and performance, business model and strategy. The Board’s assessment is described on page 100. The Board and the Audit Committee review the Company’s quarterly financial results announcements to ensure they present a fair, balanced and understandable assessment of the Company’s position and prospects to shareholders. O. Risk management The Board is responsible for the Company’s risk management system and internal controls, and their effectiveness. The Board delegates some responsibilities for risk management oversight to the Audit Committee, such as quarterly reviews of the Company’s principal and key active risks. During 2023, the Directors continued to review the effectiveness of our system of controls, risk management (including a robust assessment of the emerging and principal risks) and high-level internal control processes. This included an annual Governance and Assurance Report to all Directors, which is considered in detail by the Audit Committee and reviewed by the Board. For more information on: The Nomination and Governance Committee Report, see from page 90. External audit, see page 96 and Note 31 to the Financial Statements, on page 210. Internal Audit, see page 96. The ways in which we manage our business risks, our procedures for identifying our emerging risks, how we describe our Principal Risks and uncertainties, and our Viability statement, see Risk management and controls on the following page, and the Risk Overview from page 54. The Remuneration Committee’s work, see page 102. 82 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Corporate Governance Report Compliance with the UK Corporate Governance Code continued |
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Any areas of concern are highlighted in the Audit Committee Chair’s update to Directors at the relevant Board meeting and discussed by the Board. The Report is based on a full year-end review of the Company’s risk and control processes (incorporating financial, operational and compliance controls) and findings from assurance processes. The Directors believe that the Group maintains an effective, embedded system of internal controls and complies with the FRC’s guidance entitled ‘Guidance on Risk Management, Internal Control and Related Financial and Business Reporting’. 5. Remuneration P. Remuneration policies and practices The Remuneration Committee is responsible for determining, approving and reviewing the Company’s global remuneration principles and frameworks, to ensure that they support the strategy of the Company and are designed to promote long-term sustainable success. Q. Developing executive remuneration policy The Remuneration Committee routinely reviews the Directors’ Remuneration Policy and executive remuneration arrangements to ensure they continue to promote the delivery of the long-term strategy and support the Company’s ability to recruit and retain executive talent to deliver against that strategy. The Committee also considers remuneration arrangements in the context of corporate governance best practice and arrangements for the wider workforce, and regularly consults with its major investors on remuneration proposals. No Director is involved in determining their own remuneration arrangements or outcomes. R. Remuneration outcomes and independent judgement To ensure it maintains independent judgement when determining remuneration outcomes, the Remuneration Committee considers a range of data including detailed business and individual performance information. The Committee also consults with other Board Committees to utilise their expertise when determining performance outcomes. Further information on Directors’ appointments Chair of the Board Mr Demaré was appointed as Chair of the Board at the conclusion of the 2023 AGM, following Mr Johansson’s retirement, and he was considered independent upon appointment. Non-Executive Directors’ independence In December 2023, the Board considered the independence of the Non-Executive Directors, other than the Chair of the Board, for the purposes of the Code and the Nasdaq Listing Rules. Taking into account the recommendations set out in the Code and the Nasdaq Listing Rules, the Board considers that all the Non-Executive Directors except Marcus Wallenberg are independent. Marcus Wallenberg was appointed as a Director of Astra in May 1989 and subsequently became a Director of the Company in 1999. He is a Non-Executive Director of Investor AB, which has a 3.33% interest in the issued share capital of the Company as at 7 February 2024. For these reasons – his overall length of tenure and relationship with a significant shareholder – the Board does not believe that he can be determined independent under the Code. However, the Board believes that he has brought, and continues to bring, considerable business experience and makes a valuable contribution to the work of the Board. As well as being a Non-Executive Director of AstraZeneca and Chair of the Board’s Sustainability Committee, Nazneen Rahman is the Director of the Sustainable Medicines Partnership (SMP), a multi-stakeholder, not-for-profit collaboration with the aim of advancing the environmental sustainability of medicines. AstraZeneca is a strategic collaborator in the SMP. Dr Rahman has recused herself from acting as the lead contact for the SMP in its relationship with AstraZeneca, and this relationship, including project work and overall programme management, is handled by other members of the SMP team. Risk management and controls Global Compliance and Group Internal Audit (GIA) Through our compliance programme and three lines of defence risk management framework (line management; Risk and Compliance functions; GIA), Global Compliance helps the Group achieve its priorities and do business the right way. It takes a global approach that addresses key risk areas, including those related to third parties and anti-bribery/anti-corruption. Its work helps us to reinforce compliant behaviours through our Code of Ethics, policies, training, advice and guidance. We also conduct risk assessment activities and foster a culture where individuals can raise concerns. We take alleged compliance breaches and concerns seriously. We investigate and take appropriate disciplinary and remediation action to address and prevent reoccurrence through internal functions and external advisers. Depending on breach severity, the Group may need to disclose and/or report the incident to a regulatory or government authority. Global Compliance provides assurance insights to the Audit Committee on compliance matters. GIA carries out a range of audits and periodically reviews the assurance activities of other Group functions. The results from these activities are reported to the Audit Committee. Global Compliance and GIA share outcomes and coordinate reporting on compliance matters throughout the organisation. GIA is established by the Audit Committee on behalf of the Board and acts as an independent and objective assurance function guided by a philosophy of adding value to improve the operational control framework of the Group. The scope of GIA’s responsibilities encompasses, but is not limited to, the examination and evaluation of the adequacy and effectiveness of the Group’s governance, risk management and internal control processes in relation to the Group’s defined goals and objectives. Among others, internal control objectives considered by GIA include: > Compliance with significant policies, plans, procedures, laws and regulations. > Consistency of operations or programmes with established objectives and goals, and effective performance. > Safeguarding of assets. Based on its activity, GIA is responsible for reporting significant risk exposures and control issues identified to the Board and to senior management, including fraud risks, governance issues and other matters needed or requested by the Audit Committee. It may also evaluate specific operations at the request of the Audit Committee or management, as appropriate. For more information on the Remuneration Committee, see the Directors’ Remuneration Report, from page 102. AstraZeneca Annual Report & Form 20-F Information 2023 83 Strategic Report Corporate Governance Financial Statements Additional Information Corporate Governance Report / Compliance with the UK Corporate Governance Code |
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Considering the interests of our stakeholders is fundamental to our Group’s strategy. The following table identifies our most strategically significant stakeholders and summarises the engagement that has been undertaken by management during 2023. Patients and patient networks Payers Investor community Healthcare professionals Academic and R&D partners Commercial collaborators and partners Overview Significance of the stakeholder to the business Patients are at the heart of what we do. Our stakeholders include individual patients, caregivers and patient advocacy organisations. We listen to their experiences, embedding these insights into every aspect of our work, and partner with them to enable access to high quality, resilient healthcare systems, ensuring that the medicines and services we develop have the greatest impact on their lives. AstraZeneca works closely with payers, which includes governments and medical insurance companies among others, to understand the impact of pricing medicines on public and private budgets. Overview Significance of the stakeholder to the business The Board and management maintain regular and constructive dialogue with investors to communicate our strategy. We provide objective information about performance to enable investors to put a fair value on the Company and ensure our continued access to capital. Healthcare professionals (HCPs) are the interface with patients. They provide insights into clinical trial design and prescribing, advising patients on administering medicines, providing safety reports, collaborating in clinical studies and assisting with the ethical and transparent distribution of medicines. We collaborate with academic institutions and non-profit R&D partners globally to access the best science, to stimulate innovation and to deliver life-changing medicines to patients. Partnering is an increasingly important part of our business. By combining forces, AstraZeneca and our partners can accelerate innovative science to bring life-changing medicines to patients. Interests Issues and factors which are most important to the stakeholder group > Diverse insights gathered and incorporated throughout the drug development process to minimise patient burden and measure outcomes they care about most. > Ensuring healthcare systems are designed and delivered with the patient in mind. > Providing transparent, accessible information. > Ensuring the safety, efficacy and affordable accessibility of our medicines. > Sustainable access to safe and effective innovative medicines. > Pricing of medicines, including breakthrough therapies and impact on public budgets. > Containing reimbursement expenditure. > Attracting business investment. > Investing in research and scientific collaborations. Interests Issues and factors which are most important to the stakeholder group > Financial and commercial performance. > R&D strategy, resource allocation and pipeline development. > Culture, values and behaviours. > Exposure to geopolitical and macroeconomic risks. > ESG matters. > Development of medicines for unmet medical need. > Education and information on advances in medical science. > Accurate and balanced information on licensed medicines, including up-to-date safety data. > Uninterrupted supply of quality medicines. > Ethical and transparent interactions with industry. AstraZeneca had more than 1,500 active academic collaborations during 2023: > To advance innovative technology and science. > To address key scientific challenges. > To access the next generation of science leaders. > Shared vision and values. > Development of innovative medicines and improving access to them. > Trust and transparency in research, disclosures and relationships with stakeholders. > Willingness to collaborate with industry peers to optimise outcomes for common stakeholders, e.g. patients, physicians, policymakers and healthcare systems. Engagement Examples of engagement in 2023 > Increased number of diverse patient engagements throughout drug development and commercialisation. > Patient Partnership Program expanded into new disease areas and evolved across novel initiatives to support end-to-end patient engagement. > Involved patients and caregivers in co-creation of multiple programmes. > Expanded patient support and affordability programmes. > Collaborated with patient advocacy organisations on key healthcare system transformation projects, enabling access to improved healthcare and medicines across the globe. > Engaged governments and policymakers to increase understanding of the AstraZeneca business model, to support investment in life sciences and to improve access to new medicines. > Engaged in discussions on evolving the current reimbursement system for medicines in the US. > Hosted site visits and tours at our manufacturing and R&D facilities for international and local politicians. Engagement Examples of engagement in 2023 > Ongoing communications including quarterly results calls, in-person and virtual meetings, and roadshows. > Regular events at medical conferences and periodic updates on portfolio and pipeline developments. > Receptions hosted by the Chair of the Board. > Engaged in HCP educational events, advisory boards and in clinical trials. > Responded to more than 199,000 HCP enquiries and processed over 100,000 adverse event reports from HCPs. > We support more than 900 early career positions in R&D globally, including graduates, placement students, sponsored PhDs, and postdoctoral researchers. > Worked side-by-side with academic researchers in dedicated university laboratories. > Through our Open Innovation programme, we openly share molecules, data and challenges with academic researchers; we currently have four ongoing clinical trials, over 100 pre-clinical studies and three new collaborative research projects aimed at addressing key scientific challenges. > Joint seminars, education sessions and consortia with research institutions, e.g. Royal Society and Partner of Choice Network. > Regular alliance leadership meetings established to enhance collaboration and create a ‘One Team’ mentality across organisations. > Joint responsibility for deliverables and outcomes across functions at all levels. > Multiple discussions with regulators, policy makers, patient groups and clinicians, to inform development and commercial strategy to best meet patient needs. Outcomes Actions which resulted > Delivery of impactful and actionable insight to drive patient-focused drug development and commercialisation. > Increased patient support programmes across therapy areas. > Driven global consensus and brought about tangible healthcare system changes at a country level. > Established working relationships with key government stakeholders. > Regular meetings and events organised to increase understanding about how governments can better support life sciences investment and improve patient access to new medicines. Outcomes Actions which resulted > Maintained access to senior and next-level/operational management, including increased virtual engagement. > Continued to streamline external-facing materials to provide increased transparency, following discussion with shareholders. > Increased focus on ESG matters within results announcements and shareholder engagements. > Advisory boards informed clinical research and product strategy. > Clinical studies have led to new products. > Exchange of information supported HCP clinical decision making. > Enabled innovative solutions though research collaboration. > New technology, new targets and new biomarkers. > Publications. > Capability to offer studentship and post-doctoral programmes to facilitate scientific discovery. > Optimisation of outcomes through combined skillsets and use of technologies/ platforms to research new medicines, enabling faster delivery of medicines to patients. > Multiple late-stage trials initiated across multiple disease/patient types. > Accelerated launch of new medicines in unique areas. > Greater collaboration and relationships with industry partners and stakeholders. 84 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Corporate Governance Report Connecting with our stakeholders |
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Patients and patient networks Payers Investor community Healthcare professionals Academic and R&D partners Commercial collaborators and partners Overview Significance of the stakeholder to the business Patients are at the heart of what we do. Our stakeholders include individual patients, caregivers and patient advocacy organisations. We listen to their experiences, embedding these insights into every aspect of our work, and partner with them to enable access to high quality, resilient healthcare systems, ensuring that the medicines and services we develop have the greatest impact on their lives. AstraZeneca works closely with payers, which includes governments and medical insurance companies among others, to understand the impact of pricing medicines on public and private budgets. Overview Significance of the stakeholder to the business The Board and management maintain regular and constructive dialogue with investors to communicate our strategy. We provide objective information about performance to enable investors to put a fair value on the Company and ensure our continued access to capital. Healthcare professionals (HCPs) are the interface with patients. They provide insights into clinical trial design and prescribing, advising patients on administering medicines, providing safety reports, collaborating in clinical studies and assisting with the ethical and transparent distribution of medicines. We collaborate with academic institutions and non-profit R&D partners globally to access the best science, to stimulate innovation and to deliver life-changing medicines to patients. Partnering is an increasingly important part of our business. By combining forces, AstraZeneca and our partners can accelerate innovative science to bring life-changing medicines to patients. Interests Issues and factors which are most important to the stakeholder group > Diverse insights gathered and incorporated throughout the drug development process to minimise patient burden and measure outcomes they care about most. > Ensuring healthcare systems are designed and delivered with the patient in mind. > Providing transparent, accessible information. > Ensuring the safety, efficacy and affordable accessibility of our medicines. > Sustainable access to safe and effective innovative medicines. > Pricing of medicines, including breakthrough therapies and impact on public budgets. > Containing reimbursement expenditure. > Attracting business investment. > Investing in research and scientific collaborations. Interests Issues and factors which are most important to the stakeholder group > Financial and commercial performance. > R&D strategy, resource allocation and pipeline development. > Culture, values and behaviours. > Exposure to geopolitical and macroeconomic risks. > ESG matters. > Development of medicines for unmet medical need. > Education and information on advances in medical science. > Accurate and balanced information on licensed medicines, including up-to-date safety data. > Uninterrupted supply of quality medicines. > Ethical and transparent interactions with industry. AstraZeneca had more than 1,500 active academic collaborations during 2023: > To advance innovative technology and science. > To address key scientific challenges. > To access the next generation of science leaders. > Shared vision and values. > Development of innovative medicines and improving access to them. > Trust and transparency in research, disclosures and relationships with stakeholders. > Willingness to collaborate with industry peers to optimise outcomes for common stakeholders, e.g. patients, physicians, policymakers and healthcare systems. Engagement Examples of engagement in 2023 > Increased number of diverse patient engagements throughout drug development and commercialisation. > Patient Partnership Program expanded into new disease areas and evolved across novel initiatives to support end-to-end patient engagement. > Involved patients and caregivers in co-creation of multiple programmes. > Expanded patient support and affordability programmes. > Collaborated with patient advocacy organisations on key healthcare system transformation projects, enabling access to improved healthcare and medicines across the globe. > Engaged governments and policymakers to increase understanding of the AstraZeneca business model, to support investment in life sciences and to improve access to new medicines. > Engaged in discussions on evolving the current reimbursement system for medicines in the US. > Hosted site visits and tours at our manufacturing and R&D facilities for international and local politicians. Engagement Examples of engagement in 2023 > Ongoing communications including quarterly results calls, in-person and virtual meetings, and roadshows. > Regular events at medical conferences and periodic updates on portfolio and pipeline developments. > Receptions hosted by the Chair of the Board. > Engaged in HCP educational events, advisory boards and in clinical trials. > Responded to more than 199,000 HCP enquiries and processed over 100,000 adverse event reports from HCPs. > We support more than 900 early career positions in R&D globally, including graduates, placement students, sponsored PhDs, and postdoctoral researchers. > Worked side-by-side with academic researchers in dedicated university laboratories. > Through our Open Innovation programme, we openly share molecules, data and challenges with academic researchers; we currently have four ongoing clinical trials, over 100 pre-clinical studies and three new collaborative research projects aimed at addressing key scientific challenges. > Joint seminars, education sessions and consortia with research institutions, e.g. Royal Society and Partner of Choice Network. > Regular alliance leadership meetings established to enhance collaboration and create a ‘One Team’ mentality across organisations. > Joint responsibility for deliverables and outcomes across functions at all levels. > Multiple discussions with regulators, policy makers, patient groups and clinicians, to inform development and commercial strategy to best meet patient needs. Outcomes Actions which resulted > Delivery of impactful and actionable insight to drive patient-focused drug development and commercialisation. > Increased patient support programmes across therapy areas. > Driven global consensus and brought about tangible healthcare system changes at a country level. > Established working relationships with key government stakeholders. > Regular meetings and events organised to increase understanding about how governments can better support life sciences investment and improve patient access to new medicines. Outcomes Actions which resulted > Maintained access to senior and next-level/operational management, including increased virtual engagement. > Continued to streamline external-facing materials to provide increased transparency, following discussion with shareholders. > Increased focus on ESG matters within results announcements and shareholder engagements. > Advisory boards informed clinical research and product strategy. > Clinical studies have led to new products. > Exchange of information supported HCP clinical decision making. > Enabled innovative solutions though research collaboration. > New technology, new targets and new biomarkers. > Publications. > Capability to offer studentship and post-doctoral programmes to facilitate scientific discovery. > Optimisation of outcomes through combined skillsets and use of technologies/ platforms to research new medicines, enabling faster delivery of medicines to patients. > Multiple late-stage trials initiated across multiple disease/patient types. > Accelerated launch of new medicines in unique areas. > Greater collaboration and relationships with industry partners and stakeholders. AstraZeneca Annual Report & Form 20-F Information 2023 85 Strategic Report Corporate Governance Financial Statements Additional Information Corporate Governance Report / Connecting with our stakeholders |
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In addition to the principal stakeholders described on pages 84 and 85, the Board considers the following stakeholder groups important for the business operations and strategic direction of the Company. Community Wherever we work in the world, we aim to make a positive impact on people and the communities in which they live through our community investment. We aim to advance patient health, increase access to care, drive science innovation and build healthy and resilient communities for all. Employees Successfully acquiring, retaining and developing a talented and diverse workforce is critical to achieving our 2030 Bold Ambition. Our employees are a key part of our strategy and we are committed to being a great place to work. More information is included on pages 44 and 45. Health authorities We engage regulators globally about the manufacture, development, review, approval and marketing of our products. Governments AstraZeneca partners closely with governments around the world to promote health, support healthcare research and innovation, facilitate equitable access to innovative care solutions, and build resilient and sustainable healthcare systems. Multilateral and non-governmental organisations (NGOs) AstraZeneca partners with multilateral organisations and NGOs to deliver science-based health programming that addresses global health issues and supports the delivery of the UN Sustainable Development Goals. AstraZeneca’s commitment to reduce health inequity has also been demonstrated by donations to support patients in medically underserved communities and humanitarian settings through disaster relief efforts. Media An active and constructive relationship with the media is important to build trust with the Company’s key stakeholders by transparently reporting on the Group’s activities, including the results of key trials and business updates, as well as seeking to enhance and protect the reputation of the organisation. Suppliers and third-party providers AstraZeneca collaborates with a broad range of partners to support the development, manufacturing and delivery of life-changing medicines to patients across the world. Data led and technology driven, the Global Procurement function facilitates collaboration with diverse and ethical suppliers, pursuing some of the most ambitious sustainability targets in the industry to dramatically reduce carbon emissions throughout the supply chain. How the Board engages with stakeholders The stakeholder table on pages 84 and 85 sets out management’s main interactions with certain key stakeholders. Feedback from these interactions is provided to the Board in a variety of ways, which allows the Board to understand the key interests of stakeholders and consider them in its decision-making process. The Board undertakes additional direct engagement with stakeholders to better understand their interests and concerns, so these can be factored into its decision making. Examples of the Board’s engagement are set out in the following columns. Information on how stakeholders and other factors were considered in the Board’s principal decisions in 2023 is set out on the following page. Full Board/Other > During 2023, a number of Directors, including the Chair, the CEO and the CFO, met investors at roadshows and in one-on-one meetings. > The Chair hosted receptions focused on shareholder engagement, including events in the UK and Sweden. > The 2023 AGM was held in London, which allowed those shareholders able to attend to interact with, and ask questions of, the Board. All Directors were present at the meeting. > Investor reports and financial analysts’ consensus data are made available to the Board. Feedback is regularly provided to the Board by management on their interactions with investors. The Chair also hosted an annual reception focused on investor engagement. > The CEO and the CFO, along with other members of management, met governmental agencies and regulators to discuss matters including the pricing of medicines and equitable access. > The Board held one of its scheduled meetings during 2023 at AstraZeneca’s site in Tokyo, Japan and another at its site in Gaithersburg, MD, US. During the meetings, the Board met employees, including scientists and commercial teams, and hosted ‘townhall’ meetings. During the visits, the Chair also met with external stakeholders, including patient advocacy groups, NGOs and US government staff and officials through a series of meetings and roundtable discussions. > The CEO attended a number of scientific conferences in 2023, relevant to the Company’s main areas of R&D and Commercial activity. > Members of the Audit Committee visited the Speke, UK site where they met with the site leadership team, branding team, AstraZeneca Speke graduates and apprentices and hosted a ‘townhall’ meeting. The Committee also visited the AstraZeneca and Alexion UK marketing company site in 2023. > The CEO and senior leaders met with 15 governments and engaged at 40 events at COP28, highlighting the interconnection between climate action, health resilience and equity, and demonstrating the action at scale the Company is taking on this agenda. > The Chair of the Audit Committee took part in the following visits during 2023: a virtual visit to the AstraZeneca marketing company in Taiwan; in-person visits to the Gulf Cooperation Council (GCC) cluster in Dubai to meet with the MEA area leadership and GCC leadership teams; visit to the Chennai Global Innovation & Technology Centre which included meetings with the site leadership team and an employee ‘townhall’ meeting; and finally, a visit to the AstraZeneca India marketing company which also included meetings with senior leadership and an employee ‘townhall’ meeting. > Members of the Science Committee visited the AstraZeneca site in Cambridge, UK for a two-day meeting which included a lab visit to the Functional Genomics Centre on the first day. This was followed by a poster session with UK scientists from AstraZeneca and one-to-one meetings with global R&D leaders. In the evening, Science Committee members had informal discussions with meeting presenters from R&D. The second day included a lunch with the Directors, with each Science Committee member hosting a table of AstraZeneca scientists, including rising stars nominated by functions. > The Chair of the Remuneration Committee met with investors who hold approximately 50% of the Company’s issued share capital and with three proxy advisers to discuss the proposals for the 2024 Directors’ Remuneration Policy and its implementation for the Executive Directors in 2024. For further information, see the Remuneration Report on page 102. > The CEO, CFO and the Chair, regularly engaged with employees through in-person and online events, including ‘Ask me anything’ and ‘fireside chats’ sessions. Employees had the opportunity to ask questions in advance or during sessions. For more information on how the Management and the Board have considered Modern Slavery, see the Audit Committee report from page 94, Human Rights on page 45 and AstraZeneca’s Modern Slavery Act Statement, which is available on our website, www.astrazeneca.com. 86 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Corporate Governance Report Connecting with our stakeholders continued |
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Principal Decisions in 2023 2023 Group Funding Plan In January 2023, the Board reviewed and approved the Group’s 2023 funding plan. The Board considered: investors; and the long-term success of the Company. How the Board had regard to these matters: > Reviewed the expected funding requirements for the year ahead as well as the medium- and long-term funding and liquidity prospects. > Discussed the Group’s capital allocation priorities, the long-term strategy and the measures required to deliver the strategy, including investment in the pipeline and potential external acquisitions to further strengthen the pipeline. The Board considered the benefit of these investments for patients and investors, alongside the potential impact of acquiring debt. > Considered the Group’s liquidity position and the expectations of investors regarding the progressive dividend policy. Board Committees’ composition and succession planning During 2023, the Board reviewed and made the following appointments: > Appointment of Michel Demaré as Chair of the Nomination and Governance Committee. > Appointment of Nazneen Rahman as a member of the Remuneration Committee. > Appointment of Euan Ashley as Chair of the Science Committee. > Appointment of Euan Ashley as a member of the Nomination and Governance Committee. > Appointment of Anna Manz as a Non-Executive Director and member of the Audit Committee. The Board considered: investors; the long-term success of the Company; and maintaining high standards of business conduct. How the Board had regard for these matters: > Engaged with a number of AstraZeneca’s largest shareholders for them to hear about the search processes and to understand their views. > Considered the Board’s diversity, time commitments of the candidates and other relevant UK Corporate Governance Code provisions, as well as other Board-level succession planning considerations. > Reviewed the experience of potential candidates and met those who were shortlisted to evaluate which individuals had the skills required to support management in the continued delivery of value to shareholders and life-changing medicines to patients, while also maintaining high standards of business conduct. > Considered the succession requirements of the Board, the length of tenure of the current Non-Executive Directors and the independence requirements as set out in the UK Corporate Governance Code, and the importance of ensuring a smooth and orderly transition. > Considered the continuity and reassurance the appointments provided to management and investors, and had regard to the likely consequences of the decision in the long term and the interests of those most affected. Acquisitions and collaborations to strengthen the pipeline During 2023, the Board considered, and approved, a number of transactions to strengthen the Group’s pipeline and accelerate the development of potentially life-changing medicines. These included the acquisition of CinCor Pharma; the acquisition of a rare disease gene therapy portfolio and technologies from Pfizer; the research and collaboration agreement with Quell Therapeutics; the approval of the equity investment and global research and collaboration agreement in cell and gene therapy with Cellectis; the approval of the in-licensing of AZD5004 from Eccogene; the acquisition of Gracell Biotechnologies; and the acquisition of Icosavax. The Board considered: investors; the long-term success of the Company; employees; patients; and maintaining high standards of business conduct. How the Board had regard to these matters: > Reviewed the unmet medical need and considered how the transactions would further strengthen the Group’s pipeline. > Considered the benefits to patients if the Group was able to accelerate the development of novel treatments, which could potentially deepen clinical responses and improve patient outcomes. > Considered the financial impact of the transactions on the Group’s viability and capital allocation priorities, alongside the financial benefits from the acquisitions if the technologies were successful. Divestment of Pulmicort Flexhaler in the US During 2023, the Board approved the divestment of Pulmicort Flexhaler in the US to Cheplapharm. The Board considered: investors; the long-term success of the Company; patients; and maintaining high standards of business conduct. How the Board had regard to these matters: > Considered the Company’s long-term strategy, the status of Pulmicort intellectual property in the US and the potential impact this may have on revenue, as well as the investment required in the pipeline to ensure the development of further life-changing medicines. > Recognised the importance in ensuring that appropriate arrangements were in place to ensure the continued supply of medicines to patients. > Considered the financial benefit of the divestment and how this could be reinvested, to further benefit patients and shareholders. Settlement of patent litigation In July 2023, the Board approved the settlement of the patent litigation with Bristol-Myers Squibb and related parties relating to Imfinzi and Imjudo. The Board considered: investors; the long-term success of the Company; and maintaining high standards of business conduct. How the Board had regard to these matters: > Reviewed the financial impact of the settlement and the potential benefits and risks of continuing with the litigation. > Considered the settlement value compared to the cost of continued litigation and the potential size of damages which were being sought. > The time and efforts required from management in continuing to defend the litigation and the potential distraction this could create. Board’s reserved powers and delegation of authority to the CEO In May 2023, the Board reviewed its reserved powers and delegation of authority to the CEO, and made the following changes: Set out below are examples of how key stakeholders, Section 172(1) duties and other matters are considered by the Board when making its Principal Decisions in 2023. Corporate Governance Report Principal Decisions For the Section 172(1) statement, see page 74. For more information on funding, see Note 28 to the Financial Statements from page 195. For more information on committees’ composition and succession planning, see the Nomination and Governance Committee Report from page 90. For more information on acquisitions and collaborations, see Business development from page 42. For more information on patent litigation, see Patent litigation in Note 30 to the Financial Statements from page 204. AstraZeneca Annual Report & Form 20-F Information 2023 87 Strategic Report Corporate Governance Financial Statements Additional Information Corporate Governance Report / Principal Decisions |
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> Increased the CEO’s limit for business development transactions. > Introduced a new reserved power covering significant restructuring programmes. > Introduced a new reserved power covering the settlement of major litigation. > Introduced new references to approving material capital structure changes (including reductions of capital and share buybacks) and approving any changes to AstraZeneca PLC’s stock exchange listings or status as a public limited company. The Board considered: the long-term success of the Company and the need to maintain high standards of business conduct. How the Board has regard for these matters: > Considered that decisions should be made efficiently and at the appropriate level within the Company. > Considered the results of a high-level benchmarking exercise carried out in respect of those FTSE 20 companies that publish this information. > Considered the Group’s total revenue, operating profits and net cash flow from operating activities which have increased significantly since the last review. > Considered the governance implications of potential changes, particularly that the change would reduce the number of projects reviewed by the Science Committee prior to Board approval. The Board agreed that the Science Committee would be free, if it wished, to continue to be briefed on relevant transactions with a value exceeding the previous threshold but below the newly approved threshold. > Considered the overall Group materiality threshold applied by AstraZeneca’s auditors, PwC, in its audit work when setting the new thresholds. > Considered comparisons with peers and best practice. > Reviewed updates to the proposed role of the Board (including adding a reference to the Board’s role to safeguard and enhance AstraZeneca’s reputation), the Chair and CEO. Engaging with the wider workforce can present challenges due to the size of the workforce and the global footprint, as well as the variety of roles throughout the organisation. In addition to in-person engagements, virtual engagements help to ensure that individual Directors, as well as Board and Board Committees, have the opportunity to meet with a range of employees from across the global workforce, and to hear and understand their views. The Board believes that this alternative approach continues to be the best model of engagement for the Group and ensures that the Board has access to the views of the workforce regardless of location and provides meaningful information and data that the Board can use when considering the impact of strategic decisions on employees. Additionally, the chosen mechanisms allow all Directors to engage with a wider cross-section of the global workforce. Workforce culture During 2023, the Board reviewed the biannual Workforce Culture and Employee Engagement Report, which demonstrated how our Values and behaviours are embedded throughout all levels of the workforce. The report contains a summary metric dashboard which is divided into categories reflecting AstraZeneca’s Values and behaviours. Where the Board has concerns that the culture does not reflect our Values, the Board seeks assurances from management that remedial action has been taken and, where necessary, requests senior management’s attendance at Board meetings to discuss corrective actions. 92% of employees took part in the November 2023 Pulse survey. ‘Townhall’ meetings, ‘fireside chats’ and ‘Ask me anything’ discussions Both Non-Executive Directors and Executive Directors regularly participate in meetings with sites, or large groups of the workforce – either virtually or in person. These enable direct engagement between the Board and employees, including Q&A sessions, such as the Chair ‘fireside chat’. During the year, among other events, the Board hosted in-person ‘townhall’ meetings for employees in Japan and US sites, which were also broadcast to other sites in the region to increase reach and participation. Employee opinion surveys (Pulse) Twice a year, employees are invited to take part in an opinion survey, which seeks their views of the business. The results are reviewed by management and trends are monitored. The results are shared with the Board, which enables the Directors to understand the views and sentiments of the workforce. 89% of employees stated they believe strongly in AstraZeneca’s future direction and key priorities in the November 2023 Pulse survey. Site visits During 2023, Directors visited various Group sites across the world, including those in India, Dubai, Japan, the US, the UK and the Alexion campus in Dublin, Ireland. The majority of visits were in person but, to maximise engagement opportunities, some were virtual, including those to the AstraZeneca businesses in the Nordics, Spain and Taiwan. >10 AstraZeneca Group sites around the world visited by Directors during 2023. Wellbeing Where appropriate – for example in relation to recent humanitarian events – the Board receives regular updates on the steps taken by management to create safe working environments and support the mental and physical wellbeing of the workforce. Engaging with our workforce AstraZeneca is committed to being a great place to work. Engagement with employees is an important element in ensuring an environment in which all employees are respected, where openness is valued, diversity celebrated and every voice heard. We rely on our global workforce to uphold our Values, deliver our strategic priorities and work to sustain and improve short- and long-term performance. For AstraZeneca, ‘global workforce’ includes our full-time and part-time employees, fixed-term workers and external contractors working full- or part-time, anywhere in the world. The Directors believe that the Board as a whole should be responsible for engaging with and understanding the views of the workforce. Consequently, the Board has chosen not to implement any of the three methods set out in the Code. Instead, it uses various mechanisms and long-standing communication channels in place across the Group that enable and facilitate engagement with the global workforce. These include the Board’s review of the global workforce Pulse survey and the biannual Workforce Culture and Employee Engagement Report; Board members hosting ‘townhall’ meetings for the workforce, including Q&A sessions; and review of data relating to talent, development, inclusion and diversity initiatives, and online social media channels. Directors also visit our sites and carry out virtual engagements, which facilitate understanding of business operations and also provide opportunities for interactions between Directors and the workforce, including engagement with high-potential employees. Where required, issues or concerns raised by the workforce are fed back to management and discussed by the Board. Whenever relevant, the Board considers the views of the workforce and the potential impact on the workforce when it makes key decisions. 88 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Corporate Governance Report Principal Decisions continued |
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2023 overview The UK Corporate Governance Code states that there should be an annual evaluation of the performance of the board, its committees, the chair and individual directors and that, for larger listed companies such as AstraZeneca, this should be externally-facilitated at least every three years. The Company was due to have an externally-facilitated evaluation in 2023. The Board elected to postpone the externally-facilitated review until 2024 and instead run an internal performance evaluation in 2023. This was considered to be a proportionate approach in light of the change in Chair during the year. Given the 27 April 2023 effective date of appointment of Michel Demaré as Board Chair, the Board concluded that it would be a better use of time and resources for the next externally-facilitated annual performance review to take place in 2024, so that at least the first 12 to 18 months of the Board’s work under the new Chair could be taken into account. The internal evaluation was run via a web-based survey covering a wide range of topics that were broadly similar to topics from previous evaluations. A report was prepared using the answers to this survey which was discussed by the Board at its meeting in December 2023, and was used by the Chair as the basis for individual conversations with each Board member prior to the full Board discussion. As part of each Director’s individual discussion with the Chair during the Board evaluation, his or her contribution to the work of the Board and personal development needs were considered. Directors’ training needs are met by a combination of: internal presentations and updates, and external speaker presentations, as part of Board and Board Committee meetings; specific training sessions on particular topics, where required; and the opportunity for Directors to attend external courses at the Company’s expense, should they wish to do so. The Nomination and Governance Committee also reviews the composition of the Board to ensure that it has the appropriate expertise, while also recognising the importance of diversity. For more information on the Nomination and Governance Committee’s work, see the Nomination and Governance Committee Report from page 90. 2023 outcomes and actions against prior year recommendations > The Board continues to operate effectively with an atmosphere that enables candid discussion. Its relationship with management, including the CEO, CFO and SET, was highly rated. > Each Director continues to perform effectively and demonstrate commitment to their role, as does the Chair (whose evaluation by Board members, absent the Chair, was led by the senior independent Non-Executive Director). > The composition of the Board was highly rated. > The Board has a good understanding of the views and requirements of its key stakeholders. > All of the Board’s Committees continue to operate effectively. > The Board’s contribution to strategy development, oversight of the R&D pipeline and effectiveness in monitoring and considering key external developments were highly rated. The Board oversees risk effectively. Succession planning and people oversight continues to be a key area of focus. Key priorities for 2024 included strategy, financial performance and capital allocation, monitoring the R&D pipeline, market-specific and geopolitical issues, and Board and SET succession planning. To address areas highlighted by the 2022 annual Board performance evaluation, various steps were taken during 2023, including: > The re-establishment – following the COVID-19 pandemic – of a strong programme of in-person Board meetings, including site visits, balanced with some Board meetings being held virtually to reduce the Board’s carbon footprint and the need for Directors to undertake intercontinental travel. > Focusing the Nomination and Governance Committee’s work regarding Non-Executive Director succession planning on addressing the needs of the Board in the period to 2026, when four current Non-Executive Directors will reach nine years’ tenure, with the appointment of Anna Manz in September 2023 being the first tangible outcome of this work. > Continued routine work by the Nomination and Governance Committee to plan for future CEO succession, including reviews of both internal and external potential candidate options. > Arranging a session to enable the Board to review how management was approaching drug pricing legislation in the US. As part of the Board performance evaluation, Directors were asked to consider the following areas: > Board composition > Stakeholder oversight > Board dynamics > Board Committees > Strategic oversight > Risk oversight > Succession planning and people oversight > Priorities for change AstraZeneca Annual Report & Form 20-F Information 2023 89 Strategic Report Corporate Governance Financial Statements Additional Information Corporate Governance Report / Board performance evaluation Corporate Governance Report Board performance evaluation |
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Non-Executive Directors’ experience, as at 31 December 2023 Finance Management Sales & Marketing Tech & Digital Business Science Pre-AZ Pharma Medical Doctor/Physician Industry-specific UK US Europe Geographic 6 8 4 5 6 7 3 4 3 3 Asia 1 Inclusion and diversity The Board views all aspects of diversity among Board members as important considerations when reviewing its composition. The Board also aims to maintain a balance in terms of the range of experience and skills of individual Board members, which includes relevant international business, pharmaceutical industry and financial experience, and appropriate scientific and regulatory knowledge. The biographies of Board members set out on pages 78 and 79 give more information about current Directors in this respect. The Board has adopted an Inclusion and Diversity Policy (the Policy), which is applicable to the Board and its Committees. The Policy reinforces the Board’s ongoing commitment to all aspects of diversity and to fostering an inclusive environment in which each Director feels valued and respected. Although the Board appoints candidates primarily based on merit and the relevance of their background and experience, measured against objective criteria, it recognises that an effective Board, with a broad strategic perspective, requires diversity. The Policy provides a commitment to use at least one professional search firm that has signed up to the ‘Voluntary Code of Conduct for Executive Search Firms’, to help recruit Directors from a broad, qualified group of candidates, to increase diversity of thinking and perspective. The Board’s approach to inclusion and diversity continues to yield successful results. As at 31 December 2023, 31% of the Company’s full Board identifies as an ethnic minority, 45% of the Company’s Non-Executive Directors are women, and women make up 46% of the full Board. The information presented in the following tables was collected on a self-reporting basis. The Board, SET and Company Secretary were provided with the prescribed table, and asked to complete based on how they identify. The Board is pleased that the Company meets the On behalf of the Nomination and Governance Committee (the Committee), I am pleased to present the Committee’s report on its activities during 2023. Committee’s role The Committee works on behalf of the full Board to review the composition of the Board and its Committees and carry out succession planning for all Board positions, including taking the lead in the search for and recruitment of new Directors. The Committee ensures the Board has an appropriate balance of expertise, experience and diversity. A matrix that records the skills and experience of current Board members is one of the main tools used by the Committee to do this. The matrix is shown in the charts to the left. Decisions relating to the appointment of Directors are made by the entire Board based on the Committee’s recommendations, taking into account the merits of the candidates and the relevance of their background and experience, measured against objective criteria, with care taken to ensure appointees have enough time to devote to the Board’s business. Board and Board Committee changes during the year Following the retirement of Leif Johansson from the Board at the end of the AGM on 27 April 2023, I was appointed Chair of the Board. In addition, I also assumed the role of Chair of this Committee. Further details about the Chair succession process are set out in the 2022 annual report. In April, the Board appointed Euan Ashley as Chair of the Science Committee, in succession to Nazneen Rahman, effective 1 June 2023, with Nazneen remaining a member of the Science Committee. Euan was appointed as a member of the Nomination and Governance Committee, effective the same date. The Board appointed Nazneen Rahman as a member of the Remuneration Committee, effective 1 May 2023. In May, the Board appointed Anna Manz as a Non-Executive Director and a member of the Audit Committee with effect from 1 September 2023. The appointment process was led by the Committee and involved Anna meeting with multiple Directors. Anna brings extensive cross-sector business skills and knowledge to the Board, having held international roles in North America and Asia-Pacific and served as an executive and non-executive in large, listed companies. Anna’s significant financial and strategic leadership experience, including in areas such as risk, treasury and accounting, will enable her to fully contribute to the work of our Audit Committee. Nomination and Governance Committee members > Michel Demaré (Chair) (from 27 April 2023) > Leif Johansson (Chair) (until 27 April 2023) > Philip Broadley > Sheri McCoy > Nazneen Rahman > Euan Ashley1 1 Appointed as a member of the Committee on 1 June 2023. “The Nomination and Governance Committee works on behalf of the full Board to review the composition of the Board and its Committees and carry out succession planning for all Board positions.” The Nomination and Governance Committee’s terms of reference are available on our website, www.astrazeneca.com. 90 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Nomination and Governance Committee Report |
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updated diversity policy targets as specified in the FCA’s Policy Statement on Diversity and inclusion on company boards and executive management, which was published in April 2022: > 46% of the Board are women, above the target of at least 40%. > Following the appointment of Aradhana Sarin as CFO, the Company meets the policy target that at least one of the Chair of the Board, Chief Executive Officer, senior independent Non-Executive Director or Chief Financial Officer be a woman. > The Board satisfies the target of at least one member of the Board being from a non-white ethnic minority background. As well as being considered in decisions about succession and Board appointments, inclusion and diversity is integrated across our Code of Ethics and associated workforce policy for the organisation as a whole. We were named 2nd ranking Healthcare company in the FTSE 100 for women on boards and in leadership in the FTSE Women Leaders Review. For the year ended 31 December 2023, following the retirement of Katarina Ageborg in January 2023 and Sharon Barr’s appointment as Executive Vice-President, BioPharmaceuticals R&D in August 2023, women represented 43% of the SET and its leadership teams. Ongoing training and development On her appointment as an independent Non-Executive Director, Anna Manz commenced an ongoing tailored induction programme to provide an understanding of the Group and which reflects Anna’s existing expertise and Committee membership. Key areas of the induction programme include: > Meetings with members of the Board, SET and other senior management. > Meeting with external legal advisers. > Meeting with the external auditors. > Access to a digital reading room which provides information on the Group, including financial performance, pipeline information, key Company policies, investor and analyst reports, media updates and guidance on directors’ duties and listed company requirements. In addition to arranging comprehensive induction programmes when new Non-Executive Directors are appointed to the Board, the Committee recognises the importance of continuing development and training opportunities for all Directors. We are committed to developing a culture of lifelong learning throughout our organisation. Specific sessions with internal and external experts are periodically arranged for the full Board, to ensure that Directors have access to specialist knowledge across a broad range of areas to support their strategic decision making. For example, this year Board members participated in a roundtable event with key external experts in the areas of lung cancer and ATTR during the Board meeting in Tokyo, Japan to discuss the latest science and clinical research in those areas. At least annually, I discuss with each Director his or her contribution to the work of the Board and personal development needs. Directors’ training needs are met by: a combination of internal presentations and updates, and external speaker presentations, as part of Board and Board Committee meetings; specific training sessions on particular topics, where required; and the opportunity for Directors to attend external courses at the Company’s expense, should they wish to do so. Directors are encouraged to visit the Group’s sites, providing opportunities to meet local management and tour AstraZeneca facilities. Virtual visits are also arranged to allow further interactions with employees and sites. These visits further Directors’ understanding of the Group’s business and operations, as well as provide an insight into the particular challenges faced locally and opportunities to engage directly with employees and other stakeholders. Table 1. Reporting table on sex/gender representation as at 31 December 2023 Number of Board members Percentage of the Board Number of senior positions on the Board (CEO, CFO, SID and Chair) Number in executive management Percentage of executive management Men 7 54% 3 7 54% Women 6 46% 1 6 46% Non-binary – – – – – Not specified/prefer not to say – – – – – Table 2. Reporting table on ethnicity representation as at 31 December 2023 Number of Board members Percentage of the Board Number of senior positions on the Board (CEO, CFO, SID and Chair) Number in executive management Percentage of executive management White British or other White (including minority-white groups) 9 69% 3 9 69% Mixed/Multiple Ethnic Groups 1 8% – 1 8% Asian/Asian British 3 23% 1 3 23% Black/African/Caribbean/ Black British – – – – – Other ethnic group, including Arab – – – – – Not specified/prefer not to say – – – – – Succession planning The Committee considers both planned and unplanned (unanticipated) succession scenarios. The Committee split the majority of its time on this topic in 2023 between succession planning for Non-Executive Directors, successfully concluding the recruitment of Anna Manz in September and continued routine succession planning for the role of CEO, which included desktop research relating to potential external candidates and reviewing the strengths and areas of development for potential internal candidates. Korn Ferry and Lygon Group assisted the Committee with its succession planning work this year. Korn Ferry undertakes executive search assignments for the Company but has no other connection with AstraZeneca or its individual Directors. Corporate governance The Committee advises the Board periodically on significant developments in corporate governance and the Company’s compliance with the UK Corporate Governance Code. Further information on our corporate governance arrangements, including the Company’s statement of compliance with the Code during the year, is set out from page 81. Michel Demaré Chair of the Nomination and The Board’s Inclusion and Governance Committee Diversity Policy can be read in full on our website, www.astrazeneca.com. Information about our approach to diversity in the organisation below Board level can be found in People, from page 45. AstraZeneca Annual Report & Form 20-F Information 2023 91 Strategic Report Corporate Governance Financial Statements Additional Information Nomination and Governance Committee Report |
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> AstraZeneca R&D strategic science capabilities: including multi-omics and bioinformatics, and AI and computational strategies. This was supported by further in-person presentations from AstraZeneca scientists on site at Cambridge, UK covering across all R&D areas. > Acquisitions and in-licensing agreements: review for the Board the scientific case for acquisition and licensing opportunities, including: – Acquisition of CinCor Pharma, Inc., adding baxdrostat (CIN-107) to the cardiorenal portfolio. – Exclusive global licence agreement with KYM Biosciences, for CMG901, a potential first-in-class ADC targeting Claudin 18.2. – Acquisition of Neogene Therapeutics Inc., a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation TCR-Ts. – Purchase and licence agreement for a portfolio of pre-clinical gene therapy programmes and enabling technologies from Pfizer Inc. > R&D in China: The Committee had an in-person meeting with AstraZeneca China R&D and Business Development leadership to discuss external R&D landscape, innovation opportunities and future plans. > Clinical Trials Operations strategies: a review of Clinical Operations focusing on challenges and opportunities driven by internal changes and external factors. > Corporate scorecard outturn and goal setting: providing insight and feedback to the Remuneration Committee in support of 2023 achievements and 2024 goal setting relating to R&D. Euan Ashley Chair of the Science Committee Chair’s introduction The Science Committee’s (the Committee) core role is to provide assurance to the Board regarding the quality, competitiveness and integrity of the Group’s R&D activities. Our dialogue with AstraZeneca’s R&D leaders and other scientist employees, as well as visits to our R&D sites throughout the world, allows us to review and assess: > The approaches we adopt in respect of our chosen therapy areas. > The scientific technology and R&D capabilities we deploy. > The scientific strategy for maintaining our pipeline and competitiveness. > The decision-making processes for R&D projects and programmes. > The quality of our scientists, their career opportunities and talent development. > Benchmarking against industry and scientific best practice, where appropriate. We also periodically review important bioethical issues and assist in the formulation of appropriate policies in relation to such issues, agreeing these on behalf of the Board. The Committee also considers future trends in medical science and technology, and reviews, on behalf of the Board, the R&D aspects of specific business development or acquisition proposals, advising the Board on its conclusions. Activities during the year The Committee met nine times during 2023, both virtually and face to face. Our key areas of focus included: > Company strategy and strategic priorities for R&D: including key prioritised science platforms across R&D (Oncology, BioPharmaceuticals and Rare Disease) and areas of focus for long-term success, including business development strategy and external trends impacting R&D investment. Science Committee members > Euan Ashley (Chair) (from 1 June 2023) > Nazneen Rahman (Chair until 1 June 2023) > Diana Layfield > Tony Mok > Marcus Wallenberg > EVP, Oncology R&D1 > EVP, BioPharmaceuticals R&D1 > CEO, Alexion1 1 Co-opted member of the Committee. “The Science Committee’s core role is to provide assurance to the Board regarding the quality, competitiveness and integrity of the Group’s R&D activities.” The full role of the Science Committee is set out in its terms of reference, available at www.astrazeneca.com. 92 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Science Committee Report |
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and a briefing paper relating to the rollout of electronic patient information leaflets. Our focus areas during the year included: > How numerous regulations, including the IFRS Sustainability Disclosure Standards, European Sustainability Reporting Standards and Corporate Sustainability Reporting Directive (CSRD), would impact the Company’s reporting on sustainability matters and the measures being taken to ensure the Company has a single source of sustainability-related data. > The establishment and oversight of a new Sustainability Steering Committee comprised of representatives from Finance, Sustainability, Compliance, HR and Government Affairs which will be accountable to both the Committee and the Audit Committee to ensure consistency over all aspects of sustainability across the business. > The establishment and development of a health equity strategy which aims to build on existing access to healthcare programmes to enable more equitable health outcomes across the globe. > Oversight of the conduct of the CSRD double materiality assessment. > Supporting the Remuneration Committee in its consideration of how the delivery of our ESG priorities is incentivised, and reviewing performance against our ESG remuneration targets relating to AZC. > Overseeing engagement with investors on sustainability-related matters and reviewing AstraZeneca’s external disclosures. Nazneen Rahman Chair of the Sustainability Committee Chair’s introduction The Sustainability Committee (the Committee) continued its important work during 2023 to oversee the execution of the Company’s sustainability strategy. In addition to this important function, the Committee’s other roles are: > To oversee the Company’s disclosures relating to sustainability and communication of our sustainability activities with our stakeholders. > To monitor developments and best practice and provide input to the Board and other Board Committees on sustainability matters as required. > To advise the Remuneration Committee on the Company’s performance against sustainability metrics and targets. Committee meetings and other informal interactions with employees allow Committee members to engage closely with those charged with executing our sustainability strategy. This helps us develop a deeper understanding of sustainability initiatives, their progress, who executes them, and how this is done, to share with the wider Board. Activities during the year During 2023, the Committee met twice formally. In addition, the Committee facilitated a deep dive session for the full Board focusing on developments in laws and regulations relating to sustainability reporting and progress against our Ambition Zero Carbon (AZC) targets and programmes. To enhance our understanding of the sustainability initiatives in action at AstraZeneca and hear colleagues’ personal perspectives, the Committee invited employees to its meetings who were involved in workstreams and projects from across our sustainability strategy. This included hearing from R&D scientists in Macclesfield, UK about their work to recover and reuse solvents which are a material contributor to our carbon footprint Sustainability Committee members > Nazneen Rahman (Chair) > Sheri McCoy > Andreas Rummelt > Marcus Wallenberg Standing attendees at Committee meetings during 2023 included the EVP, Operations, IT and Sustainability and VP, Global SHE and Operations Sustainability. “The Sustainability Committee continued its important work during 2023 to oversee the execution of the Company’s sustainability strategy.” The full role of the Sustainability Committee is set out in its terms of reference, available at www.astrazeneca.com. For more information about sustainability at AstraZeneca, visit www.astrazeneca.com/ sustainability. AstraZeneca Annual Report & Form 20-F Information 2023 93 Strategic Report Corporate Governance Financial Statements Additional Information Sustainability Committee Report Sustainability Committee Report |
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The Committee also spent considerable time keeping ourselves updated on developments in the reporting and regulatory environment, including the proposed governance and audit reforms in the UK, SEC updated interpretations on non-GAAP measures reporting, and sustainability-related reporting. This year, we continued our approach of a combination of in-person and virtual Committee meetings and interactions with colleagues from across the organisation. Of particular note this year were the Committee’s in-person visits to AstraZeneca’s manufacturing site in Speke, UK, and to the AstraZeneca and Alexion UK marketing companies. I also made in-person visits to the marketing companies in India and the Gulf Cooperation Cluster (GCC) in Dubai and a visit to the Global Innovation and Technology Centre in Chennai, India. These interactions, along with the in-depth sessions I refer to above, have allowed Committee members to maximise our engagement with colleagues across the business, deepen our understanding of the priorities and challenges facing many different markets and business areas, and hear a wide range of employees’ views directly. We hope you find the Committee’s Report useful and informative, and, as ever, I welcome any feedback. Philip Broadley Chair of the Audit Committee The Committee continues to apply appropriate challenge to the Company’s management; for example, the Committee challenged the timing of recognition of provisioning for certain legal items and their presentation as non-core items. This matter was subject to robust discussions and scrutiny from the Committee before it was satisfied with management’s approach. The Committee’s agenda continues to be driven by the Company’s key active risks and key strategic programmes which are considered at every Committee meeting, and inform the Committee’s agenda of in-depth sessions which, this year, have included sessions on: > Our Operations function, as we continue to evolve our supply chain capabilities. > Our IT/IS function, to gain a better understanding of how we seek to mitigate cybersecurity threats. > The China market environment and healthcare industry trends, the enforcement environment, and how risks are being proactively managed. > How the Company seeks to mitigate the impact of inflationary pressures across the business. > Organisational activities to support the Company’s 2030 Bold Ambition. These sessions allowed the Committee to continue exploring specific aspects of risks in their ‘real world’ business contexts, in direct dialogue with people in the business that have responsibility for managing these risks. Chair’s introduction On behalf of the Audit Committee (the Committee) I am pleased to present the Committee’s report on its activities and the significant matters we considered during 2023. In 2023, following his election as Chair of the Board, Michel Demaré stepped down as a member of the Committee immediately following the AGM in April. My thanks go to Michel for his valuable contributions to the Committee’s work over the past few years. We also welcomed Anna Manz as a member of the Committee following her appointment to the Board in September. Anna brings wide-ranging, international experience from a number of industries, and has already begun to make effective contributions to the work of the Committee. The Committee believes that it has carried out its responsibilities effectively throughout the year, and to a high standard, providing independent oversight. It has had good support from AstraZeneca personnel and PwC, the Company’s auditors. The Committee’s main responsibilities include monitoring the integrity of financial reporting and formal announcements relating to financial performance, reviewing the effectiveness of internal controls and risk management systems, and overseeing the external and internal audit processes. “The Committee’s main responsibilities include monitoring the integrity of financial reporting and formal announcements relating to financial performance, reviewing the effectiveness of internal controls and risk management systems, and overseeing the external and internal audit processes.” Audit Committee members1 > Philip Broadley (Chair) > Michel Demaré2 > Deborah DiSanzo > Sheri McCoy > Anna Manz3 2 Member of the Committee until 27 April 2023. 3 Appointed as a member of the Committee on 1 September 2023. 1 Routine attendees at Committee meetings include: the CFO; the Chief Human Resources Officer; Chief Compliance Officer and General Counsel; the VP, Ethics & Transparency and Deputy Chief Compliance Officer; the Deputy General Counsel, BioPharmaceuticals; the VP, Group Internal Audit; the SVP Finance, Group Controller & Head of Global Finance Services; and the Company’s external auditor. The Committee, and separately the Committee Chair, also meet privately and on an individual basis with attendees which helps ensure the effective flow of material information between the Committee and management. The CEO and other members of the SET attend when required by the Committee. 94 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Audit Committee Report The full role of the Audit Committee is set out in its terms of reference, available at www.astrazeneca.com. |
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Committee overview Committee composition In December 2023, the Board determined the Committee met the UK, US and Swedish composition requirements by virtue of Philip Broadley and Anna Manz having recent and relevant financial experience for the purpose of the UK Corporate Governance Code (the Code), having competence in accounting and/ or auditing for the purpose of the Disclosure and Transparency Rules, being financial experts for the purposes of the Sarbanes-Oxley Act, and having expertise in accounting and auditing for the purposes of the Swedish Corporate Governance Code and Swedish Companies Act. The Board determined that all members of the Committee are independent for the purposes of the Code and that the Committee members as a whole have competence relevant to the sector in which the Company operates, by virtue of their experience of working in science-driven, healthcare and/or pharmaceutical industries, or as a result of their tenure with AstraZeneca. The Committee members’ qualifications, skills and experience are detailed in their biographies on pages 78 and 79 and meeting attendance is shown on page 77. Role of the Committee The Committee’s main responsibilities include monitoring the integrity of financial reporting and formal announcements relating to financial performance, reviewing the effectiveness of internal controls and risk management systems, and overseeing the external and internal audit processes. The Committee reports to the Board the principal matters it considers and any significant concerns it has or that have been reported to it. Further information about the Committee’s role and work during the year is set out in this Audit Committee Report. Activities during the year Financial reporting Effective internal controls, appropriate accounting practices and policies, and the exercise of experienced judgement by the Committee and the Board underpin AstraZeneca’s financial reporting integrity. The Committee’s activities in this area in 2023 included: > Reviewing key elements of the Financial Statements and the estimates and judgements contained in the Group’s financial disclosures, as well as considering the appropriateness of management’s and the external auditor’s analysis and conclusions on judgemental accounting matters. The significant financial reporting issues considered are described in detail in the table from page 98. Further information on the significant accounting matters considered is included in the Financial Review under Critical accounting policies and estimates from page 72 and within our Group Accounting Policies from page 152. > Considering the completeness and accuracy of the Group’s reported financial performance against its internal and external key performance indicators. > Reviewing the preparation of the Directors’ Viability statement and considering the adequacy of the analysis supporting the assurance provided by that statement, as well as the going concern assessment and adoption of the going concern basis in preparing this Annual Report and the Financial Statements. > Reviewing quarterly updates from both management and PwC on the programme of activities relating to control over financial reporting and the effectiveness of testing that has been performed across the internal control environment. > Considering the external auditor’s reports on its audit of the Group Financial Statements, as well as reports from management, Group Internal Audit (GIA), Global Compliance and the external auditor on the effectiveness of our system of internal controls and, in particular, our internal control over financial reporting. This included consideration of compliance with applicable provisions of the Sarbanes-Oxley Act – in particular, the status of compliance with the programme of internal controls over financial reporting implemented pursuant to section 404 of that Act. > Discussing financial reporting considerations in relation to significant transactions that occurred in the year, the valuation and presentation of the defined benefit pension arrangements, impairment of intangible assets, restructuring programmes and the presentation of collaboration and alliance revenues. The Committee also reviewed developments in sustainability reporting requirements and the Company’s activities, governance frameworks and approach in compliance with enacted and emerging regulations in relation to sustainability. Risk identification and management The Committee continued its regular reviews of the Group’s approach to risk management, the operation of its risk reporting framework and risk mitigation. This included consideration of the manner in which the risk management process was embedded in the Group such that the Committee could be assured that management’s accountability for risks was clear and functioning effectively. The Company’s risk framework, described further from page 54, provides the context for the Committee to consider the Directors’ Viability statement which is underpinned by the assurance provided through a ‘stress test’ analysis under which key profitability, liquidity and funding metrics are tested against severe downside scenarios. Each of these scenarios assumes that the associated risks crystallise and that management will take mitigating actions against those risks. The Committee considered in detail the validity of each scenario. This included obtaining additional analysis from management as to the indirect or unintended consequences of its proposed mitigating actions including, for example, assessing the likely response of a broader range of stakeholders. The Committee also assessed whether the proposed mitigations were viable. The Committee is updated on key active and emerging risks facing the Company through a quarterly risk management report from the CFO. The likelihood of each of the risks materialising and its potential impact was monitored by the Committee and the reports from the CFO enabled the Committee to track the trend applicable to each risk compared to the previous quarter. The composition and profile of these risks informs the Committee’s agenda of in-depth sessions. For example, an upward trend, in terms of the likelihood and potential impact of the risk, was noted for the key active risk relating to IT, cyber risk and data security, therefore the Committee spent additional time with representatives from the IT function to understand those risks and the actions being undertaken to mitigate them. Audit Committee Report AstraZeneca Annual Report & Form 20-F Information 2023 95 Strategic Report Corporate Governance Financial Statements Additional Information More information on the basis of preparation of Financial Statements on a going concern basis is set out on page 227 and in the Financial Statements on page 152. Further information on the significant financial reporting issues considered is set out in the table from page 98. Further information about the Principal Risks faced by the Group and the Viability statement is set out in Risk Overview from page 54. |
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Cyber risk, digital security and information governance Our approach to identifying, assessing and managing material cybersecurity risks (including those that result from the use of third parties in business processes and data management) is integrated within our Group-wide approach to managing risk. Failure in information technology or cybersecurity has been identified as a Principal Risk. Mitigations are in place to manage these risks, and these are monitored, and their effectiveness regularly reported, for example in KPI dashboards provided to management and the Committee. Incidents are managed and reported using the cybersecurity incident management framework which in turn is connected to the Group’s crisis management framework. Cybersecurity risks are overseen by the Committee, who perform an in-depth review annually. Their reviews are supported by senior management, the VP, Group Internal Audit (GIA) and other assurance or providers as required. Cybersecurity risks (including previous incidents) have not materially affected our business strategy, results of operations or financial condition. Sustainability reporting and climate-related risk The Committee is responsible for overseeing sustainability-related disclosures that are linked to the Financial Statements, which includes the TCFD Summary Statement and the EU Taxonomy disclosures in this Annual Report and the extended TCFD Statement published separately. These statements are also reviewed by the Sustainability Committee, to support the Committee’s review. The Committee received updates in the current year regarding the proposed and/or enacted regulations by the US, EU, UK and the International Sustainability Standards Board (ISSB) on sustainability reporting, as well as the ongoing assessment of potential double materiality topics for the Company under EU regulations. Legal and Compliance The Committee’s activities in this area included reviewing: > Quarterly reports from the Legal function to monitor the status of significant litigation matters and governmental investigations. > Quarterly reports from Global Compliance to provide oversight of key compliance incidents (both substantiated and unsubstantiated), possible trends and the dispersion of incidents across our business functions and management hierarchy. The reports included corrective actions taken so that the Committee could assess the effectiveness of controls, and monitor and ensure timely remediation. > Reporting on compliance with AstraZeneca’s Code of Ethics to ensure high ethical standards and that AstraZeneca operates within the law in all countries where we operate. > The monitoring, review, education and improvements made to support assurance that the risk of modern slavery and human trafficking is eliminated, to the fullest extent possible, from AstraZeneca’s supply chain. Internal Audit The Committee reviewed GIA’s activities, including: > Reviewing quarterly reports of work carried out by GIA, including the status of follow-up actions with management. In 2023, GIA provided assurance over compliance with significant policies, plans, procedures, laws and regulations, as well as risk-based audits across a broad range of key business activities and continued its thematic reporting to the business. The 2023 audit plan was aligned to our key active risks and wider risk taxonomy. Separate meetings are arranged to discuss follow-up actions in more depth with specific teams, when required by the Committee. > Carrying out the annual effectiveness review of GIA in late 2023 by considering its performance against the internal audit plan and key activities. > Approving the 2024 internal audit plan, which is aligned to our key active risks and wider risk taxonomy. > Considering the geographic presence, reach and capabilities of GIA and the appropriateness of the Group’s resource allocation for this vital assurance function. The Committee noted the continued contributions of GIA in supporting and delivering value to the business and the Committee during the year. The Committee supports GIA’s continued efforts to deploy its resources in line with the shape and size of the overall organisation and was satisfied with the quality, experience and expertise of the GIA function. An independent External Quality Assessment of GIA is performed every five years and was last performed in 2021. External audit The Company’s external auditor, PwC, provided quarterly reports to the Committee over key audit and accounting matters, and business processes, internal controls and IT systems. The Committee oversaw the conduct, performance and quality of the external audit, in particular through its review and challenge of the coverage of the external auditor’s audit plan and subsequent monitoring of progress against it. The Committee maintained regular contact with PwC through formal and informal reporting and discussion throughout the year, with a continued focus on maintaining audit efficiency and quality. The Committee also sought management’s feedback on the conduct of the audit and considered the level of and extent to which the auditors challenged management’s assumptions. The Committee also received a formal letter and report from the Financial Reporting Council (FRC) following the joint FRC and Public Company Accounting Oversight Board (PCAOB) inspection of PwC’s 2022 audit of AstraZeneca. The FRC’s inspection was rated as “Good” (the highest rating possible) and there were no ‘Key’ or ‘Other’ findings. The FRC also recognised a number of areas of good practice in relation to the conduct of the audit. A number of interactions took place between Committee members and PwC during the year, outside of formal Committee meetings, to enhance the Committee’s understanding of the audit process including the Committee Chair joining PwC’s Account Planning Workshop to meet face-to-face with PwC team members responsible for auditing AstraZeneca’s global entities. 96 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Audit Committee Report continued For further information, see IT and IS resources on page 41. For more information on our Code of Ethics, see page 49, and on Anti-bribery and anti-corruption, see page 39. AstraZeneca’s Modern Slavery Act Statement is available on our website, www.astrazeneca.com. |
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The Committee reviewed audit and non-audit fees of the external auditor during the year, including the objectivity and independence of the external auditor through the application of the Audit and Audit-Related Services Approval Policy, as described further on page 100. Engagement with employees and other stakeholders The Committee regularly interacts with members of management below the SET and seeks wider engagement with the Group’s employees and other stakeholders, during deep dive sessions at formal Committee meetings and as separate engagements. Committee members undertook a mixture of in-person and virtual interactions with a wide range of teams from across the organisation, including: Information Technology and Information Security; Operations and Procurement; Human Resources; Global Business Services; the AstraZeneca and Alexion marketing companies in the UK; the Speke, UK manufacturing site; and the marketing companies for the GCC and India. The breadth of these interactions is crucial as it enhances the Committee’s understanding of the business and provides valuable insights into the key issues and challenges relating to, and current and emerging risks associated with, our activities in these areas. The Committee welcomes the opportunity to engage directly with employees in these meetings which provide an opportunity to gauge employee sentiment and hear their views directly. The Committee also uses these interactions to communicate the importance it attaches to compliance and our ‘Speak Up’ culture. Reporting and regulatory environment The Committee has kept abreast of developments in the reporting and regulatory environment. This has included consideration of the proposed governance and audit reforms in the UK, SEC updates on clawbacks and non-GAAP reporting, consultations on sustainability-related reporting requirements in a number of jurisdictions, and requirements to disclose further information about diversity and inclusion on company boards in the UK from 2023. The Committee was also briefed on thematic reviews published by the FRC during the year, including those on fair-value-measurement and climate-related metrics and targets. Ensuring the quality of external financial reporting to shareholders and other stakeholders remains paramount to the Committee. This includes its assessment of the annual reports to ensure that, taken as a whole, they are fair, balanced and understandable (for which the process is described on page 100). External validation of the Annual Report is an important indicator of the quality of our reporting. The Committee was pleased with the feedback from the FRC that it received in 2023 on the 2022 Annual Report: > The FRC undertook a routine corporate reporting review of the 2022 Annual Report and did not raise any questions or queries that required further correspondence, which the Committee consider a reflection of the quality financial reporting and compliance undertaken by AstraZeneca. The FRC highlighted some areas where reporting could be further enhanced which management and the Committee have considered in preparing this Annual Report. > The FRC also reviewed our reporting in the context of the 2018 UK Corporate Governance Code and raised no significant points in this respect. > In the FRC’s 2022/2023 Annual Review of Corporate Governance Reporting, the FRC highlighted the following aspects of the 2022 Annual Report as examples of best practice: (i) how the impact of AstraZeneca’s learning culture contributed positively to retention and promotion rates and more accurate succession planning; and (ii) how AstraZeneca’s strategy and KPIs in relation to scientific measures are linked to remuneration. > The FRC Lab’s report on business model-focused reporting highlighted our ‘Life-cycle of a medicine’ text and diagram in the 2022 Annual Report (an updated version of which appears on page 11 of this Annual Report) as a best practice example of how an issuer can better meet investor needs, particularly for a reader who is not a pharmaceutical expert. Committee performance The Committee conducted the annual evaluation of its own performance, referring to the Committee-specific results of a Board performance review survey prepared by the Company Secretary’s team. The results were reported to and discussed with the Committee and the Board. The overall results of the survey were positive and noted the Committee’s efforts and focus. Audit Committee Report AstraZeneca Annual Report & Form 20-F Information 2023 97 Strategic Report Corporate Governance Financial Statements Additional Information Further information about the audit and non-audit fees for 2023 is disclosed in Note 31 to the Financial Statements on page 210. |
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Matter considered Committee’s conclusion and response Valuation of intangible assets See Financial Review from page 58 and Note 10 to the Financial Statements from page 172. The Group carries significant intangible assets on its Consolidated Statement of Financial Position arising from the acquisition of businesses and intellectual property (IP) rights to medicines in development and on the market. Each quarter, the CFO reports on the carrying value of the Group’s intangible assets as well as the specific assets identified as at risk of impairment. In respect of intangible assets that are identified as at risk of impairment, the Committee receives information on the difference between the carrying value and management’s current estimate of discounted future cash flows for these products (the headroom). Products will be identified as ‘at risk’ because the headroom is small or, for medicines in development, there is a significant potentially adverse event such as the publication of clinical trial results which could significantly alter management’s forecasts for the product. The reviews also cover the impact on any related contingent consideration arising from previous business combinations. The Committee considered the impairment reviews of the Group’s intangible assets. Impairments of $17 million arose in relation to launched products, and $417 million arose in relation to products in development. The Committee assured itself of the integrity of the Group’s accounting policy and models for its assessment and valuation of its intangible assets, including understanding the key assumptions and sensitivities within those models. The Committee also considered the internal and external estimates and forecasts for the Group’s cost of capital relative to the broader industry. The Committee was satisfied that the Group had appropriately accounted for the identified impairments. Revenue recognition See Financial Review from page 58 and Note 1 to the Financial Statements from page 160. The US is our largest single market and accounted for 42% of our Total Revenue in 2023. Revenue recognition, particularly in the US, is affected by rebates, chargebacks, returns, other revenue accruals and cash discounts. In 2023, a new category of revenue termed Alliance Revenue was included on the face of the Statement of Comprehensive Income, and comparative information re-presented. Alliance Revenue includes profit shares, revenue shares or royalties from defined collaborative arrangements, and was previously a sub-category of Collaboration Revenue. The Committee pays attention to management’s estimates of these items, its analysis of any unusual movements and their impact on revenue recognition. The Committee receives regular reports from management and the external auditor on this complex area. The US market remains highly competitive with diverse marketing and pricing strategies adopted by the Group and its peers. The Committee recognised the close monitoring and control by management of the overall gross-to-net deductions. The Committee was consulted on the proposed update to presentation of Alliance and Collaboration Revenues, and aligned on the usefulness of enhanced disclosures of Alliance Revenues for better visibility and reflect differences in revenue profiles for Alliance and Collaboration Revenues. The Committee also discussed the accounting considerations for key milestones in Collaboration Revenue. Alternative performance measures (APMs) See Financial Review from page 58. AstraZeneca reports APMs to provide helpful supplementary information to the IFRS measures to enable a better understanding of the Group’s financial performance and position. Accounting for the acquisition of Alexion in 2021 resulted in more significant items being classified as non-core, which continue impacting performance in the current year, especially relating to the unwind of fair value uplift of inventory and amortisation of allocated fair value of purchased intangible assets. The fair value uplift of inventory was fully unwound in the year, hence the amortisation of intangibles will remain the material non-core item from the acquisition transaction. There were some significant one-off legal settlements in the year which were classified as non-core items in line with the Group’s policy. Management carefully analyses the presentation of various items to ensure it is fair and balanced, and follows guidelines issued by the European Securities and Markets Authority and the SEC, as well as FRC thematic reviews. The Committee carefully considered management’s presentation of the non-core items and noted that the presentation was consistent with prior years for the items. The Committee further considered management’s assessment and recommendation to present the $1,020 million legal provision costs as non-core items, and concurred with management that the presentation was appropriate due to their significance and consistent with classification in prior years. The Committee reviewed proposed disclosures for non-GAAP items in line with the various regulatory guidance and concurred with management that the presentation enabled additional helpful guidance. Litigation and contingent liabilities See Note 30 to the Financial Statements from page 204. AstraZeneca is involved in various legal proceedings considered typical to its business and the pharmaceutical industry as a whole, including litigation and investigations relating to product liability, commercial disputes, infringement of IP rights, the validity of certain patents, antitrust law, and sales and marketing practices. In the current period, net legal provisions of $1,020 million were recorded for three legal proceedings within non-core items once the criteria for recognising a provision were met. Of the matters the Committee considered in 2023 the more significant included: the settlements in the Nexium and Prilosec product liability litigation, the Imfinzi patent litigation and the Alexion shareholder litigation. The Committee carefully considered the timing of recognition and presentation of these provisions and concurred with management’s assessment. The Committee was also satisfied that the Group was effectively managing its litigation risks including seeking appropriate remedies and continuing to defend its IP rights vigorously. Significant financial reporting issues considered by the Committee in 2023 98 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Audit Committee Report continued |
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Significant financial reporting issues considered by the Committee in 2023 continued Matter considered Committee’s conclusion and response Tax charges and liabilities See Note 4 to the Financial Statements from page 164. AstraZeneca’s Approach to Taxation, which was published in December 2022 and covers its approach to governance, risk management and compliance, tax planning, dealing with tax authorities and the level of tax risk the Group is prepared to accept, can be found on our website, www.astrazeneca.com. The Group has business activities around the world and incurs a substantial amount and variety of business taxes. AstraZeneca pays corporate income taxes, customs duties, excise taxes, stamp duties, employment and many other business taxes in all jurisdictions where due. In addition, we collect and pay employee taxes and indirect taxes such as value-added tax. The taxes the Group pays and collects represent a significant contribution to the countries and societies in which we operate. Tax risk can arise from unclear laws and regulations as well as differences in their interpretation. The Committee reviews the Group’s approach to tax, including governance, risk management and compliance, tax planning, dealings with tax authorities and the level of tax risk the Group is prepared to accept. During 2023, the Committee considered the tax accounting implications of a UK Group company’s intragroup purchase of certain intellectual property as well as developments in certain uncertain tax positions in the year. The Committee considered the analysis provided by management and concurred with the presentation and reporting of these items. The Committee was satisfied with the Group’s practices regarding tax liabilities, including, most notably, its response to developments in the corporate income tax environment. Segmental reporting See the Key Judgement within Note 6 to the Financial Statements from page 167. Management has reviewed the developments in the year and determined the Group continues to operate as a single segment based on key decisions on resource allocation and performance monitoring being carried out at a Group level by the SET. There were no significant changes in the Group’s business during the year, with the Alexion integration continuing as envisioned. The Committee received reports from management regarding considerations for segmental reporting based on the current operations and management of the business. The Committee considered the analysis provided by management and concurred with management that presenting AstraZeneca’s performance under one segment was appropriate. Retirement benefits See Financial Review from page 58 and Note 22 to the Financial Statements from page 183. Accounting for defined benefit pension and other post-retirement benefits remains an important area of focus. The present value of these liabilities is sensitive to changes in long-term interest rates, future inflation and mortality expectations. The assumptions used to value the liabilities for the Group’s main post-retirement benefit obligations are updated every quarter along with asset valuations. The Group is cognisant of the wider regulatory environment and local requirements around funding levels and contributions. In May 2023, the triennial actuarial valuation as at 31 March 2022 for the UK defined benefit pension scheme was agreed with AstraZeneca Pensions Trustee Limited (the Trustee of the UK pension scheme) and submitted to the Pensions Regulator. In December 2023, the Group enacted a charge over the Company’s Cambridge Biomedical Campus site, to provide long-term security to the AstraZeneca Pension Fund. Guaranteed Minimum Pensions (GMP) equalisation is now largely complete and most UK retirees were offered flexibility to reshape their benefit through a Pension Increase Exchange option. In May 2023, the Group executed a buy-out of its qualified US Defined Benefit Pension Plan with an external insurer. All Plan liabilities have been discharged and the Plan has been wound-up. The Committee was satisfied that the Group’s contribution policy and actuarial assumptions used to value liabilities were appropriate during the year. The Committee monitors the funding level of the Group’s defined benefit obligations on a quarterly basis, alongside key developments. The Committee also received a separate update from the Global Pensions team covering key activities over the year. The Committee was reassured by the Group’s engaged and balanced approach to managing the risks associated with its defined benefit obligations, noting the completion of the actuarial valuation ahead of the statutory deadline. The Committee reviewed and concurred with management’s accounting and presentation of pension balances. The Committee is cognisant of the need to adhere to local funding regulations and noted the security provided by the Group, which underwrites obligations to members. The Committee was satisfied with the progress made on GMP equalisation, noting the additional flexibility offered. The Committee was satisfied with the process and outcome of the US buy-out, noting that it reduces long-term financial risk to the Group and provides security to participants. AstraZeneca Annual Report & Form 20-F Information 2023 99 Strategic Report Corporate Governance Financial Statements Additional Information Audit Committee Report |
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Fair, balanced and understandable assessment As in previous years, at the instruction of the Board, the Committee undertook an assessment of this Annual Report to ensure that, taken as a whole, it is fair, balanced and understandable and provides the information necessary for shareholders to assess the Company’s position and performance, business model and strategy. The Committee reviewed the Company’s governance structure and assurance mechanisms for the preparation of this Annual Report and, in particular, the contributor and SET member verification process. The Committee received an early draft of this Annual Report to review its proposed content and the structural changes from the prior year and to undertake a review of the reporting for the year, following which the Committee members provided their individual and collective feedback. In addition, in accordance with its terms of reference, the Committee (alongside the Board) took an active part in reviewing the Company’s quarterly announcements and considered the Company’s other public disclosures which are managed through its Disclosure Committee (the Committee was updated on matters considered by the Disclosure Committee regularly throughout the year). To aid its review further, the Committee also received a summary of the final Annual Report’s content, including AstraZeneca’s successes and setbacks during the year and an indication of where they were disclosed within the document. The processes described above allowed the Committee to provide assurance to the Board to assist it in making the statement required of it under the Code, which is set out from page 81. Internal controls Information on the Company’s internal controls is included in the Audit, risk and internal control section in the Corporate Governance Report on page 82. During the period covered by this Annual Report there was no change in our internal control over financial reporting that occurred that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. At the January 2024 Committee meeting, the CFO presented the conclusions of the evaluation by the CEO and CFO of the effectiveness of our disclosure controls and procedures that is required by Item 15(a) of Form 20-F as at 31 December 2023. Based on their evaluation, the CEO and the CFO concluded that, as at that date, the Company maintained an effective system of disclosure controls and procedures. External auditor PwC is the Company’s external auditor. In April 2023, PwC was reappointed as the Company’s auditor for the financial year ended 31 December 2023, its seventh consecutive year as auditor, having first been appointed for the financial year ended 31 December 2017, following a competitive tender carried out in 2015. Sarah Quinn continued as the lead audit partner at PwC for 2023 following her appointment in January 2022. Audit, audit-related and other assurance services provided by the external auditor The Committee maintains the Audit and Audit-Related Services Approval Policy (the Policy) for the pre-approval of all audit services, audit-related services and other assurance services undertaken by the external auditor. The principal purpose of the Policy is to ensure that the independence of the external auditor is not impaired. The pre-approval procedures permit certain audit and audit-related services to be performed by the external auditor, subject to annual fee limits agreed with the Committee in advance. Pre-approved audit and audit-related services below the clearly trivial threshold (within the overall annual fee limit) are subject to case-by-case approval by the SVP Finance, Group Controller & Head of Global Finance Services. Pre-approved audit services included services in respect of the annual financial statement audit (including quarterly and half-year reviews), attestation opinion under section 404 of the Sarbanes-Oxley Act, statutory audits for subsidiary entities, and other procedures to be performed by the independent auditor in order to form an opinion on the Group’s Consolidated Financial Statements. The pre-approved audit-related services, which the Committee believes are services reasonably related to the performance of the audit or review of the Company’s Financial Statements, included certain services required by law or regulation, such as financial statement audits of employee benefit plans and capital market transactions. The Policy prohibits any tax services. Audit-related services included the assurance in relation to tax regulatory certificates required to be issued by the external auditor. The CFO (supported by the SVP Finance, Group Controller & Head of Global Finance Services), monitors the status of all services being provided by the external auditor. Authority to approve work exceeding the pre-agreed annual fee limits and for any individual service above the clearly trivial threshold is delegated to the Chair of the Committee together with one other Committee member in the first instance. A standing agenda item at Committee meetings covers the operation of the pre-approval procedures and regular reports are provided to the full Committee. All services other than the pre-approved audit and audit-related services, require approval by the Committee on a case-by-case basis. In 2023, PwC provided audit services including interim reviews of the results of the Group for the period ended 30 June 2023 and audit-related and other assurance services. The increase to the statutory audit fee for 2023 is largely driven by inflationary increases. Fees for audit-related and other assurance services amounted to 6% of the fees payable to PwC for audit services in 2023 (2022: 4%). The Committee is mindful of the 70% non-audit services fee cap under EU regulation, together with the overall proportion of fees for audit and audit-related services in determining whether to pre-approve such services. Fees for audit-related and other assurance services payable to PwC in 2023 were 7% (2022: 6%) of average audit fees over 2020 to 2022 (2022: 2019 to 2021). PwC were better placed than any alternative provider to provide these services in terms of their familiarity with the Company’s business, skills, capability and efficiency with which they could deliver the relevant services. All such services were either within the scope of the pre-approved services set out in the Policy or were presented to Committee members for pre-approval and all such services were permitted by the FRC Ethical Standard. 100 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Audit Committee Report continued |
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$30.1m $29.3m 2023 2022 Audit/audit-related and other assurance services Statutory audit fee Audit-related and other assurance services Assessing external audit effectiveness In accordance with its normal practice, the Committee considered the performance of PwC and its compliance with the independence criteria under the relevant statutory, regulatory and ethical standards applicable to auditors. The Committee assessed PwC’s effectiveness principally against four key factors, namely: judgement; mindset and culture; skills, character and knowledge; and quality control. As part of that assessment, it also took account of the views of senior management within the Finance function and regular Committee attendees. As part of the Committee’s assessment of the quality of the audit, the Committee focused on the auditor’s effective use of experts and technology as well as appropriate challenge of management’s judgements especially in relation to areas of significant financial reporting issues (as described in the table from page 98). Areas that were reviewed by the Committee included PwC’s extensive and detailed review of the valuations and assumptions related to defined benefit pension valuations and the UK group company intragroup purchase of certain IP, assumptions and calculations over Gross to Net Product Sales, legal settlements in the year, intangible asset assumptions used in cashflow modelling, and the recognition and measurement of uncertain tax liabilities. The Committee concluded that the PwC audit was effective for the financial year ended 31 December 2023. In February 2024, the Committee recommended to the Board the reappointment of PwC as the Company’s auditor for the financial year ending 31 December 2024. Accordingly, a resolution to reappoint PwC as auditor will be put to shareholders at the Company’s AGM in April 2024. In order to comply with UK legal requirements regarding the auditor’s tenure and audit tendering, the external audit must be put out to tender before the 2027 financial year. In late 2023, the Committee decided to commence the tender process for the audit mandate for the 2027 financial year. This will ensure sufficient time to carry out the process and, in the event that a new auditor is appointed, clear any conflicts and ensure a new auditor builds up the necessary knowledge and business familiarity to ensure the delivery of an effective audit. PwC is eligible to re-tender for the audit and has indicated its willingness to be one of the firms included in the tender. The Committee will lead the tender process and has approved an inclusive, competitive and transparent process by which the tender will be conducted to determine a high-quality audit delivery provider. Regulation The Committee considers that the Company has complied with the Competition and Markets Authority’s Statutory Audit Services for Large Companies Market Investigation (Mandatory Use of Competitive Tender Processes and Audit Committee Responsibilities) Order 2014 in respect of its financial year commencing 1 January 2023. AstraZeneca Annual Report & Form 20-F Information 2023 101 Strategic Report Corporate Governance Financial Statements Additional Information Audit Committee Report |
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On behalf of the Board, I am pleased to present AstraZeneca’s Directors’ Remuneration Report for the year ended 31 December 2023. At the beginning of the year, we announced the launch of our inspiring new 2030 Bold Ambition. Since launch, significant progress has already been made towards delivering on our stretching target of 15 new medicines by 2030, including the approvals of Truqap, Wainua and Airsupra. With strong revenue growth in 2023 and over 30 Phase III clinical trials underway (10 of these expected to have blockbuster potential), it is clear that AstraZeneca’s remarkable performance trajectory is set to continue to deliver value to shareholders in the years to come. Key Committee activities in 2023 The Committee was pleased to have received a high degree of support for the 2022 Directors’ Remuneration Report, with a 94% vote in favour at the Company’s 2023 AGM. An important area of focus for the Committee this year has been reviewing the current Directors’ Remuneration Policy (the Policy), which is required to be put to shareholders at the 2024 AGM. In the period since our Policy was last approved in 2021, we are proud that AstraZeneca has continued to grow and prosper under our CEO’s leadership – delivering excellent returns for shareholders, and consistently positioned first or second in the FTSE 100, materially larger in size than other UK listed companies. As a major global organisation, operating within the highly competitive global pharmaceuticals sector, the Committee is very aware of the challenges of providing competitive executive remuneration which balances the genuine pay pressures from a talent market heavily influenced by US practice, and the expectations of UK investors and the corporate governance environment. We have sought to be clear and transparent in how we link remuneration of our executives to the successful delivery of our strategy and shareholder returns. The Directors’ Remuneration Report contains the following sections: > Chair’s letter, page 102 > Remuneration at a glance, page 106 > How our performance measures for 2024 support the delivery of our strategy, page 107 > How the Remuneration Committee ensures targets are stretching, page 108 > Annual Report on Remuneration, page 109 > Directors’ Remuneration Policy, page 127 During 2023, I spent time meeting with investors who hold over 50% of the Company’s issued share capital to discuss the Committee’s proposals for the 2024 Policy. The valuable feedback received was discussed with the Committee, and was factored into the Committee’s consideration of both executive remuneration in 2024 and the Policy which will be put to shareholders for approval at the 2024 AGM. The new proposals are summarised later in this letter, and our new Policy can be found from page 127. AstraZeneca has a well-established high performance culture, and we are committed to delivering and rewarding excellent performance. Over the year, the Committee has worked closely with its independent advisor and the Audit, Science and Sustainability Committees to ensure that the financial, science and ESG measures in our incentive plans are appropriate, suitably stretching and accurately assessed in order to enable the Company to achieve the 2030 Bold Ambition and Growth Through Innovation strategy. In addition to overseeing the reward arrangements in relation to our Senior Executive Team (SET), including those for the appointment of Sharon Barr as EVP, BioPharmaceuticals R&D, we continue to look further into total reward of the wider workforce and are supportive of the Company’s efforts to ensure reward decisions are equitable by career level, geography and gender. The Committee is pleased that 35% of the employee population are eligible to participate in AstraZeneca share plans so that employees can share in the Company’s performance and align with the experience of shareholders. We are proud that AstraZeneca remains committed to paying a living wage for all employees globally. Remuneration Committee members > Sheri McCoy (Chair) > Philip Broadley > Michel Demaré > Leif Johansson1 > Nazneen Rahman2 1 Retired from the Board on 27 April 2023. 2 Appointed as a member of the Committee on 1 May 2023. “With the approval of three new medicines, over 30 Phase III clinical trials under way and industry-leading revenue growth in 2023, it is clear that AstraZeneca’s remarkable performance trajectory is set to continue to deliver value to shareholders in the years to come.” The role of the Remuneration Committee is set out in its terms of reference, available at www.astrazeneca.com. 102 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Directors’ Remuneration Report |
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AstraZeneca Global pharma peers average European pharma peers average FTSE 100 500 400 300 200 100 Dec 13 Dec 14 Dec 15 Dec 16 Dec 17 Dec 18 Dec 19 Dec 20 Dec 21 Dec 22 Dec 23 AstraZeneca’s 2023 performance Science and Innovation: 2023 saw another year of exceptional performance as we continued to expand and rapidly advance our high-quality portfolio. The scientific progress is essential for our patients who stand to benefit from our medicines and we are delighted that not only did we deliver 30 pipeline progression events, either NME Phase II starts or Phase III investment decisions, but we were also able to exceed our goal for regulatory events by delivering 46 over the year. AstraZeneca also continued to invest for the future and build our scientific leadership, with highlights including the agreement with Quell Therapeutics and proposed acquisition of Gracell Biotechnologies to advance cell therapies across oncology and autoimmune diseases and the new licensing agreement with Eccogene for a novel once daily oral GLP-1RA, adding an exciting early asset with potential as a next-generation treatment for cardiometabolic diseases, diabetes and obesity to the CVRM portfolio. Growth and Therapy Area Leadership: In 2023, the commercial and regulatory teams have made great progress driving a 3% (constant exchange rate (CER): 6%) growth in Total Revenue, despite a decline of $3,736 million from COVID-19 medicines. Excluding COVID-19 medicines, Total Revenue increased by 13% (CER: 15%). Oncology Total Revenue increased by 19% (CER: 21%) to $18,447 million following approvals of Imfinzi for biliary tract cancer and Imfinzi plus Imjudo for liver and lung cancers. Tagrisso, Imfinzi, Lynparza and Calquence were once again all stand out performers. Within BioPharmaceuticals, there was strong growth in all non-COVID-19 therapy areas. CVRM Total Revenue was up 15% (CER: 18%) to $10,628 million driven by Forxiga, Lokelma, roxadustat and Andexxa. Respiratory & Immunology Total Revenue was $6,404 million, an increase of 7% (CER: 10%). Rare Disease Total Revenue grew by 10% (CER: 12%) to $7,764 million, largely driven by Ultomiris (up 51% (CER: 52%)), along with marked contribution from Strensiq, Koselugo and Kanuma as they expand into new markets. People and Sustainability: We continue to strive to be a great place to work. We have continued to invest in developing our leaders and nurturing a culture of lifelong learning. In 2023, over 11,000 employees have participated in an immersive development experience and over 1.2 million self-guided learning modules have been completed in our learning platform Degreed. Inclusion and diversity remains an important priority; in 2023 the Company has focused on embedding equity into our talent processes, building inclusive leadership capabilities and engaging our global workforce through quarterly Power of Diversity programming, such as our spotlight on building cultural intelligence. We have continued to make progress to increase the percentage of women at senior levels, How we have performed in 2023 Total shareholder return (TSR) 2021 to 20231 +40% 1 Calculated using a three-month calendar average, from 1 October to 31 December, prior to the start and at the end of the relevant period. Delivery against strategy – 2023 Group scorecard performance2 Target 2023 outcome Science and Innovation: Annual pipeline progression Pipeline progression events 25 30 Regulatory events 35 46 Growth and Therapy Area Leadership Total Revenue $43.9bn $44.8bn Achieve Group Financial Targets Cash flow $9.3bn $9.5bn Core EPS $6.89 $7.13 2 For details of the Committee’s consideration of Group scorecard outcomes and a description of performance measures, see from page 111. AstraZeneca Global pharmaceutical peers average European pharmaceutical peers average FTSE 100 More information on the TSR peer groups for PSP awards can be found on page 115. Further detail of 2023 commercial and scientific performance can be found in the Strategic Report from page 12. advancing to 50.1%, and have strong cultural diversity in our executive cohort, with 40 countries of origin represented in executive levels. Sustainability is increasingly embedded into everything we do. The expansion of AZ Forest, raising our commitment to plant and ensure the long-term survival of over 200 million trees by 2030, will contribute to Ambition Zero Carbon and remove around 30 million tonnes of carbon dioxide from the atmosphere. Our ground-breaking partnership to deliver renewable natural gas to our US research and manufacturing sites will provide a source of clean heat which will contribute to our science-based target of reducing Scope 1 and 2 emissions (operations and fleet) by 98% by 2026, whilst also contributing to the circular economy. We celebrated AstraZeneca being ranked number 1 among pharmaceutical companies for climate action in a new STAT Report, and we were proud of our strong presence at Climate Week and the UN General Assembly as we continued to drive change at scale. 2023 remuneration outcome The Committee always seeks to ensure that the remuneration of our Executive Directors and our wider workforce reflects the underlying performance of the business. When approving outcomes, we therefore considered the Group scorecard along with wider business and individual performance over 2023, including other achievements across the enterprise, such as advancing our People and Sustainability priorities. In that context, the Committee believes that the payments outlined below fairly reflect their performance. Annual bonus – 79.5% of maximum When determining bonus outturns, the Committee considered the formulaic outcome from the Group scorecard along with wider business and individual impact and performance in 2023, including ESG achievements. The Committee determined to award an annual bonus equivalent to 79.5% of maximum to Mr Soriot and Dr Sarin (equivalent to 198.75% and 159% of base pay respectively), in line with the Group scorecard outcome. Details of the factors considered to determine the bonuses are provided from page 111. Directors’ Remuneration Report AstraZeneca Annual Report & Form 20-F Information 2023 103 Strategic Report Corporate Governance Financial Statements Additional Information |
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One half of each Executive Director’s bonus for 2023 will be deferred into AstraZeneca shares for three years to ensure further alignment with shareholder interests. Long-term incentives (LTIs) 2021 PSP – 88% of maximum Our approach aims to reward sustainable outperformance and as a result of three very strong years, our 2021 award will vest towards the upper end of the possible range. The three-year performance period for Performance Share Plan (PSP) awards granted to our senior leaders in 2021, ended on 31 December 2023. Awards for all participants will vest at 88% of maximum, as shown on page 115 and reflects strong performance across all measures, as well as delivering a three-year TSR of 40%. Policy review and remuneration in 2024 The Policy is due for renewal and we will be seeking shareholder approval for a new version of the Policy at the Company’s AGM on 11 April 2024. The new Policy is intended to remain in effect for three years from the date of the AGM. During 2023, the Committee reviewed the Policy to ensure that it continues to be aligned with corporate governance best practice and promotes the delivery of long-term shareholder value. In shaping the new Policy, we have taken into account the perspectives of shareholders gathered from consultation undertaken during 2023. I met 26 of AstraZeneca’s largest shareholders and three proxy advisors to discuss our proposals, and was pleased with the level of engagement, feedback and support received. The purpose of the new Policy is to: > Incentivise the delivery of the Company’s 2030 Bold Ambition and Growth Through Innovation strategy. > Continue to emphasise the importance the Committee places on performance-related pay. > Retain and motivate incumbent Executive Directors to deliver against our strategy. > Ensure that sufficient headroom exists to deliver market competitive performance based reward to our executives and down through the organisation. In developing the new Policy proposals, the Committee noted that AstraZeneca has changed and grown significantly since the introduction of the 2021 Policy. The Company is more complex, with the integration of Alexion and the addition of successful new therapy areas in Rare Diseases and Vaccines & Immune Therapies. TSR of 40% has been delivered in this period, and Total Revenue has increased from $26.6 billion in 2020 to $45.8 billion at the end of 2023. We face increasing external talent market pressure as our employees are rightly viewed as market-leading talent. Notably, we experience pay compression challenges under the 2021 Policy, which does not provide sufficient headroom to deploy appropriately leveraged pay for performance compensation across our most senior leadership levels. Independent benchmarking of reward demonstrates that our current remuneration policy risks limiting our ability to compete for key roles below the Board, with heads of R&D being the most highly compensated roles in the industry below CEO level. 40% of our senior leaders are based in the US and over 40% of our revenue derives from the US. The Committee is acutely aware that we must be able to compete for the best talent in the US market. The Committee recognises that US pay practices differ from the UK, and in particular that US companies may offer a combination of time-based restricted stock, performance-based stock, and sometimes market value options to executive directors. At AstraZeneca we firmly believe that executive pay should be clearly aligned to performance and therefore we are not proposing to alter the design of our incentive plans (annual bonus and PSP) in principle. However, in order to address the challenges of pay compression, and to provide a more competitive package for senior executives, we are proposing an increase to the maximum total incentive opportunity under our Policy, as set out below. The recommended changes will be accompanied by the Committee’s continued commitment to setting stretching targets, aligning to the delivery of the 2030 Bold Ambition. I believe that the proposed Policy reflects our current market position but, more importantly, should set us up for success over the next Achieved Science and Innovation: Annual pipeline progression 85% Growth and Therapy Area Leadership 87% Achieve Group Financial Targets 71% Achieved Achieved Science and Innovation: First approvals and NME volume over three years 90% Growth and Therapy Area Leadership 100% Achieve Group Financial Targets 88% Relative TSR 68% Ambition Zero Carbon (AZC) 100% Achieved 2023 Annual bonus scorecard performance1 2021 PSP performance three-year cycle of the Policy. It will further engage our executive leadership in the conversion of the strength of our pipeline to commercial success, delivering industry-leading growth and our ambition of launching 15 new medicines by 2030 off the back of our planned material financial investment in future pipeline and partnerships. The importance of retaining and motivating our incumbent Executive Directors and senior leadership team in order to drive our 2030 Bold Ambition has been a key theme in consultation discussions with our shareholders. We seek to be competitive with comparable European pharma market peers and our proposals aim to reflect the performance, market capitalisation and future ambition of the Company in that context. Proposed changes to the Policy and how it will be implemented are summarised below and in more detail on page 127. The Policy is set out from page 128. The Committee would like to highlight that the key proposed changes are strictly linked to performance-related pay. > No Policy changes are proposed in relation to base pay increases (which will not exceed the average of the relevant wider workforce) or pension arrangements (which are already in line with the relevant wider workforce). > We propose to increase the target annual bonus opportunity for the CEO, Mr Soriot, to 150% of base pay, resulting in a new maximum bonus of 300% of base pay (currently 250%), in line with the median target bonus opportunity of his global peer group. > Target annual bonus for the CFO, Dr Sarin, remains unchanged at 100% of base pay, with a maximum bonus opportunity of 200% of base pay. 1 When determining bonus outturns, the Committee considered the formulaic outcome from the Group scorecard along with wider business and individual impact and performance in 2023, including ESG achievements. 104 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Directors’ Remuneration Report continued |
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> Half of any earned bonus will be deferred into shares for three years. > For awards under the PSP our proposal is to increase the maximum award under the Policy to 850% of base pay from the current 650%, subject to appropriately stretching performance targets. This new maximum would apply to Mr Soriot in 2024 provided that it is approved by shareholders. > Dr Sarin’s 2024 PSP opportunity would increase to 550% of base pay (from 450%). > At the same time, in light of feedback received from investors, the minimum shareholding requirement for each of our Executive Directors will increase to match their maximum variable pay opportunity, being 1,150% base pay for Mr Soriot, and 750% base pay for Dr Sarin. The Committee recognises that these proposals are material if viewed in a UK context. However, the changes are necessary to increase the competitiveness of the performance-related pay opportunity in the context of the global and European pharma market. Given the size, complexity and global reach of AstraZeneca, the Committee does not consider the constituents of the FTSE 100 to be an appropriate group against which to benchmark remuneration. Our approach is to 1 Global pharma peer group consists of: AbbVie, Amgen, BMS, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Roche and Sanofi (CEO only). 2 European pharma peer group consists of: Bayer, GSK, Merck KGaA, Novartis, Novo Nordisk, Roche and Sanofi (CEO only). Remuneration includes base pay, target annual bonus and the expected value of LTI awards. Benchmarking data has been provided by the Committee’s independent adviser. look at remuneration opportunity amongst the European and global pharma peers with whom we compete for talent and compare performance and to determine a Policy which is highly weighted towards pay for performance. The charts below show our Executive Directors’ on-target and maximum opportunity relative to our defined comparator groups. Our proposed changes will bring Mr Soriot to the lower quartile of our global peer group, but will better reflect AstraZeneca’s relative position within the European peer group, moving up one position in the global and European rankings for target compensation and two positions at maximum (due to the higher proportion of pay at risk compared with peers). The increased PSP opportunity for Dr Sarin will bring her compensation into line with the global median of her peers. The importance of being able to offer our impactful and talented CEO a competitive remuneration package, has been a key area of interest raised by shareholders in consultation discussions. The Committee is not proposing to make any changes to the choice of performance metrics and their weightings for the Annual bonus or the PSP in 2024, as feedback from our shareholders is that the metrics successfully align pay with performance outcomes. Given the proposed increase in quantum, the Committee has rigorously reviewed the stretch in performance targets for 2024 to ensure they are appropriate and commensurate with delivery of excellent shareholder value. The Board considers that the proposed changes will enable our remuneration framework to be more competitive as we focus on the delivery of our 2030 Bold Ambition for our patients and shareholders. The emphasis on performance-related pay ensures that outcomes are fully aligned with shareholder interests as we address the need to attract and retain outstanding talent. The Committee took shareholders’ feedback into account on the proposed changes to the Policy, and we would like to take this opportunity to thank all those who took part for their constructive engagement and support for our proposals. Non-Executive Directors’ fees With effect from January 2024, certain of the Non-Executive Directors’ fees have been increased. This reflects the continuing increase in workload and responsibilities of non-executive directors of large, global, complex, publicly listed companies, including the importance of the Science Committee and the Sustainability Committee to the Board’s work and the workloads of these Committees. AstraZeneca Non-Executive Directors’ fees have not been increased since January 2022. No Board member participated in any decisions relating to their own fees. Further detail is provided on page 118. Next steps I hope that you find this Remuneration Report clear in explaining the 2024 Policy proposals and the implementation of our Policy during 2023. We trust that we have provided the information you need to be able to support the resolution to be put to shareholders on the new Policy and this Remuneration Report at the Company’s AGM in April 2024. Our ongoing dialogue with shareholders and other stakeholders is valued greatly and, as always, we welcome your feedback on this Directors’ Remuneration Report. Sheri McCoy Chair of the Remuneration Committee Market positioning of Executive Directors’ on-target remuneration Global pharma peers¹ European pharma peers² CEO Global pharma peers¹ European pharma peers² CFO Market positioning of Executive Directors’ maximum remuneration Global pharma peers¹ European pharma peers² CEO Global pharma peers¹ European pharma peers² CFO Lower quartile to median Median to upper quartile Current position 2024 proposal £6.62m £8.97m £10.20m £16.51m £4.15m £3.61m £4.66m £5.73m £10.38m £15.05m £28.43m £13.91m £6.56m £6.29m £7.83m £9.49m Directors’ Remuneration Report AstraZeneca Annual Report & Form 20-F Information 2023 105 Strategic Report Corporate Governance Financial Statements Additional Information |
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CEO CFO 4,410 16,853 £0 £5,000 £10,000 £15,000 £’000 Share price appreciation on long-term incentive awards PSP Annual bonus Fixed pay 2021 PSP performance Achieved 88% Lapsed 12% Group scorecard performance Achieved 79.5% Lapsed 20.5% Executive Directors’ realised pay 2023 outcomes Formulaic outcome of 2023 Group scorecard and 2021 PSP What our Executive Directors earned Looking ahead Executive Directors’ remuneration for 2024 Fixed remuneration Annual bonus Long-term incentives Shareholding requirement Post-cessation shareholding requirement Pascal Soriot (CEO) Base pay: £1,485,658 Benefits fund Pension: £163,422 (equivalent to 11% of base pay) Max: 300% base pay Target: 150% base pay Deferred: 50% for three years Max: 850% base pay Performance period: three years Holding period: two years Holding requirement: 1,150% base pay Holding requirement: 1,150% base pay for two years post-cessation Aradhana Sarin (CFO) Base pay: £951,494 Benefits fund Pension: £104,664 (equivalent to 11% of base pay) Max: 200% base pay Target: 100% base pay Deferred: 50% for three years Max: 550% base pay Performance period: three years Holding period: two years Holding requirement: 750% base pay Holding requirement: 750% base pay for two years post-cessation CEO fixed vs performance-linked (%) 33% Short-term 67% Long-term Fixed 9% Performance-linked 91% Base pay Benefits fund Pension Annual bonus – cash Annual bonus – shares PSP Annual bonus (halved)* PSP ’24 Executive Directors’ variable pay Performance period Deferral period Holding period ’25 ’26 ’27 ’28 *Half of the annual bonus is deferred for three years. See from page 111 for further details on plan design. Based on maximum payout scenarios for the CEO assuming maximum of 300% and 850% of base pay for annual bonus and PSP respectively. CFO fixed vs performance-linked (%) 36% Short-term 64% Long-term Fixed 13% Performance-linked 87% Base salary Benefits fund Pension Annual bonus – cash Annual bonus – shares PSP Based on maximum payout scenarios for the CFO assuming maximum of 200% and 550% of base pay for annual bonus and PSP respectively. Fixed pay consists of base pay, benefits fund and pension. Further information on Executive Directors’ realised pay for 2023 is on page 109. See from page 110 for further information on the annual bonus and PSP outcome. When determining bonus awards, the Committee considered the formulaic outcome from the Group scorecard along with wider business and individual impact and performance in 2023, including ESG achievements. 106 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Remuneration at a glance |
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Strategic pillar Strategic pillar Financial targets Science and Innovation Growth and Therapy Area Leadership Achieve Group Financial Targets Remuneration performance measures Remuneration performance measure Remuneration performance measures Science indices Our science measures incentivise the development of NMEs and the maximisation of the potential of existing medicines. Bonus performance is assessed on pipeline progressions through Phase II and Phase III clinical trials. These reflect the outcome of nearer-term strategic investment decisions, whereas, in contrast, PSP performance is assessed on the volume of NMEs in Phase III and the registration stage, which reflects the outcome of longer-term strategic investment decisions. Additionally, we measure regulatory submissions and approvals for bonus, and regulatory approvals for PSP to drive the conversion of scientific progress into commercial revenue over the short term (bonus) and the longer term (PSP). Together, these science measures incentivise innovation and sustainable success along the length and breadth of the pipeline, leading to commercial growth. Total Revenue Our Total Revenue measure is included in the bonus and the PSP, reflecting the importance of incentivising sustainable growth in both the short and longer term. Cash flow Ensures that we can sustain investment in our pipeline and Therapy Areas while at the same time meeting our capital allocation priorities. Cash flow is included in both the bonus and the PSP, ensuring a focus on both short- and longer-term cash flow generation and balance sheet strength. Core EPS Incentivises operational efficiency and cost discipline, and remains a key measure of our profitability and a focus for our investors. Total shareholder return (TSR) Assessed relative to our peer group of companies, the measure rewards positive performance that our shareholders also directly benefit from. This measure incentivises outperformance versus our peer group, and promotes the delivery of long-term sustainable returns for our shareholders. Strategic pillar People and Sustainability We are committed to people and making a difference to society. Assessment of performance against this pillar is captured through a holistic review of each Executive Director’s individual performance (detailed on pages 112 and 113) as part of the final determination of annual bonus, including consideration of our progress against our ESG aspirations: > Continuing to make our Company a great place to work by delivering our inclusion and diversity strategy and learning and development programmes. > Ensuring we operate in the smartest way and increase the speed of delivery of our life-changing medicines to patients through our Future of Work strategic initiative. > Leading the way in our efforts to improve access to healthcare and build health system resilience. Ambition Zero Carbon This measure incentivises the elimination of our Scope 1 and Scope 2 GHG emissions through 2025 with targets verified in line with the science of climate change, where we will innovate to avoid, reduce and substitute to become zero carbon. AstraZeneca aims to continue to deliver great medicines to patients while maintaining cost discipline and a flexible cost base, driving operating leverage and increased cash generation. To incentivise and reward delivery of great performance over the short and longer term, the Committee carefully considers the balance of science, financial and ESG measures between the Annual bonus and PSP. Our focus on incentivising innovative science aligns with our patient-centric culture, as we strive to push the boundaries of science to deliver life-changing medicines to patients. The 2024 performance measures are closely aligned with our strategic priorities, as shown below. Key Annual bonus PSP KPI For more information about our strategic priorities, see page 12. For more information about the 2024 performance measures, see from page 111. AstraZeneca Annual Report & Form 20-F Information 2023 107 Strategic Report Corporate Governance Financial Statements Additional Information Directors’ Remuneration Report / How our performance measures for 2024 support the delivery of our strategy How our performance measures for 2024 support the delivery of our strategy |
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We set stretching targets that incentivise our leaders to deliver exceptional performance, and to drive sustainable results for our patients, our employees and our shareholders. 2024 targets: > The Committee has reviewed the proposed targets against internal and external forecasts, including market consensus and peer group performance, and is comfortable that the level of stretch promotes truly exceptional performance in line with the delivery of our 2030 Bold Ambition. > In real terms, financial performance goals under the 2024 Group scorecard and PSP would require achievement above prior year outturns and growth in excess of the average expected of the industry, particularly when taking the significant capital investment expected to be made during the performance period. Consistent with our approach in prior years we undertake the following robust process to setting annual bonus and PSP targets and assessing outcomes: Stage 1 – Target setting Science targets are based on a cohort of scientific opportunities specified at the start of the performance period. Opportunities represent potential achievements through the pipeline, from an early stage where our scientists work to discover new molecules, through to ultimately obtaining approvals and getting new medicines to patients. Rewarding success at each stage recognises the importance of creating and maintaining a long-term sustainable pipeline. Stretch of proposed targets is reviewed by the Science Committee taking into account factors such as the expected net present value of the pipeline and the anticipated financial contribution it will make, past performance, the external regulatory environment, and internal resourcing and efficiencies. Targets for realisation of these opportunities are ambitious. The outlook for the delivery of the pipeline is increasingly challenging given the rising proportion of new modalities and innovation, representing previously untested science. Proposed targets for the Ambition Zero Carbon measure are reviewed and endorsed by the Sustainability Committee and exceed the 1.5°C Paris Agreement glide path. Our decarbonisation ambitions are increasingly challenging to deliver in the context of broader enterprise growth, particularly the higher supply volumes required to fulfil demand for our medicines. Financial Targets metrics align with the Company’s Mid-Term Plan (MTP), which sets out the financial framework for delivering our ambitious strategy over a three-year period. The MTP process includes detailed business reviews, during which plans and efficiencies of each unit are challenged, leading to a proposed MTP for the Board to review and challenge. The Committee sets targets based on the Board-approved MTP, considering consensus expectations, independent analytics and anticipated challenges and opportunities. Whilst Total Revenue and Core EPS targets are set at budget exchange rates at the beginning of the performance period and evaluated at those rates at the end of the performance period (so that any beneficial or adverse movements in currency do not impact reward outcomes), the Committee also compares targets against prior plans at constant exchange rates, to ensure that new targets incentivise ambitious levels of growth. Where consensus figures do not align with internal forecasts, the Committee seeks to understand why a difference exists (such as differences in assumed capital expenditure). This range of data is used by the Committee to ensure the stretching nature of performance targets is robustly tested. Additionally, the PSP TSR measure is designed to reward strong performance relative to our peers. Stage 2 – Committee review and approval of targets The Committee thoroughly reviews and challenges targets proposed by management, working in partnership with the Science and Sustainability Committees to ensure targets are stretching and robust. The Committee is provided with considerable supporting material for each metric and receives briefings from senior leaders across AstraZeneca. The science measures are reviewed and endorsed by the Science Committee, with a focus on ensuring that the targets will result in long-term sustainable value creation, and the Committee reviews and approves the full cohort of opportunities. The ESG metric within the PSP is aligned to our Ambition Zero Carbon goal and reflects the importance of eliminating GHG emissions in our Scope 1 and Scope 2 operations through 2025. The Ambition Zero Carbon metric has been reviewed and endorsed by our Sustainability Committee. Committee members participate in the full Board discussions on the strategy, MTP and budget, which form the basis for the targets. The Committee considers how proposed financial targets align with the MTP and budget; prior years’ outcomes (in absolute terms and against target); how the ambition has changed from the prior MTP and budget; external guidance the Company has provided or plans to give; consensus from external financial analysts and factors it may be impacted by; and the underlying assumptions. Statistical analysis conducted by the Committee’s independent adviser is also used to assess the proposals. This includes an assessment of historical levels of performance volatility. Stage 3 – Performance assessment At the end of the period, final performance against each metric is assessed. Outcomes are calculated based on performance against each weighted metric. Each performance measure is assessed on a standalone basis, so that underperformance against one measure cannot be compensated for by overperformance against another. Data for the metrics is taken from the Group’s financial reports which are reviewed by the Audit Committee and approved by the Board. The Science Committee independently considers and informs the Committee whether science achievements represent a fair and balanced outcome, reflecting genuine achievements and pipeline progression. Ambition Zero Carbon outcomes are validated by the Sustainability Committee. Apart from Cash flow, which is set at actual rates of exchange, financial metrics are set at budget rates of exchange and evaluated at those rates at year end, which means they are not directly comparable year-on-year. The Committee is, however, provided with data to allow it to conduct year-on-year analyses. Stage 4 – Determination of Executive Directors’ bonuses For annual bonus, the fairness of the formulaic Group scorecard outcome is considered in the context of overall business performance and the experience of shareholders. Such considerations include TSR performance and each Executive Director’s personal impact on the delivery of the strategy, wider ESG performance and other organisational achievements, such as inclusion and diversity targets and the realisation of technology-based milestones. Each year, there are important individual deliverables beyond the scorecard metrics which are taken into account when determining individual bonuses. Having considered the Group scorecard outcome, overall business performance, the experience of shareholders and individual performance, as detailed from page 112, the Committee carefully determines a final bonus outcome for each Executive Director that is considered fair and appropriate for the year’s performance, and is in the best interests of shareholders. 108 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance How the Remuneration Committee ensures targets are stretching |
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Executive Directors’ realised pay for 2023 (single total figure of remuneration) The table below sets out all elements of realised pay receivable by the Executive Directors in respect of the year ended 31 December 2023, alongside comparator figures for 2022. This includes the vesting of PSP awards from 2021 following the three-year performance period. These shares are subject to a further two-year holding period. The significant increase in AstraZeneca’s share price over the period of grant to vest has provided the Executive Directors with a significant increase in value of the equity components of their reward. £3,945,583 of Mr Soriot’s and £374,506 of Dr Sarin’s 2023 realised pay is attributable to share price increases. The benefit of the increased share price has also been experienced by shareholders. The Committee did not exercise any discretion in relation to the LTI outcomes or the formulaic outcome of the Group scorecard. £’000 Base pay Taxable benefits Pension Other Total fixed Annual bonus Long-term incentives1 Total variable Single total figure Share price appreciation as % of single total figure Pascal Soriot 2023 1,429 140 157 – 1,726 2,839 12,288 15,127 16,853 23% 2022 1,367 136 150 – 1,653 3,127 10,305 13,432 15,085 19% Aradhana Sarin 2023 915 46 101 – 1,062 1,455 1,893 3,348 4,410 8% 2022 876 161 96 – 1,133 1,602 –2 1,602 2,735 – 1 Long-term incentive values disclosed in 2022 have been recalculated using the average closing share price for the three months ended 31 December 2023. See page 114. 2 Dr Sarin was appointed as CFO on 1 August 2021, and had no LTI awards which completed their performance period in 2022. The following sections provide further detail on the figures in the above table, including the underlying calculations and assumptions and the Committee’s performance assessments for variable remuneration. The Annual bonus section is set out from page 110 and the Long-term incentives section from page 114. Information about the Executive Directors’ remuneration arrangements for the coming year, ending 31 December 2024, is highlighted in grey boxes. The elements within the Executive Directors’ realised pay are colour coded: > Fixed remuneration has a light blue border and is found on page 110. > Annual bonus has a yellow border and can be found on pages 110 to 114. > Long-term incentives (LTI) has a magenta border and can be found on pages 114 to 117. Executive Directors’ remuneration This section of the Directors’ Remuneration Report sets out the Executive Directors’ remuneration for the year ended 31 December 2023, alongside the remuneration that will be paid to Executive Directors during 2024. Key: Audited information Content contained within the Audited panel indicates that all the information within has been subject to audit. Audited Planned implementation for 2024 Content contained within a grey box indicates planned implementation for 2024. Audited Directors’ Remuneration Report / Annual Report on Remuneration AstraZeneca Annual Report & Form 20-F Information 2023 109 Strategic Report Corporate Governance Financial Statements Additional Information Annual Report on Remuneration |
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Annual bonus Annual bonus in respect of performance during 2023 Bonus potential as % of base pay Bonus payable in cash Bonus deferred into shares Total bonus £’000 Target Maximum awarded Pascal Soriot 125% 250% 1,419 1,420 2,839 79.5% max Aradhana Sarin 100% 200% 727 728 1,455 79.5% max 2023 Annual bonus Annual bonuses earned in respect of performance during 2023 are included in the realised pay table. Detailed information on the Committee’s approach to target setting and assessment of performance is set out from page 112. Half of the Executive Directors’ pre-tax bonus is compulsorily deferred into Ordinary Shares which are released three years from the date of deferral. Bonuses are not pensionable. 2023 2024 £’000 Total taxable benefits Taxable benefits Pascal Soriot 140 In line with 2023 Aradhana Sarin 46 In line with 2023 Audited Taxable benefits The totals within taxable benefits include the CEO’s allowance under AstraZeneca’s UK Flexible Benefits Programme, under which he can select benefits or take his allowance, or any proportion remaining after the selection of benefits, in cash (£115,660 taken as cash). The value of personal tax advice provided to each Executive Director in 2023 was £18,687 and £45,120 for the CEO and CFO respectively. 2023 2024 £’000 Change from 2022 Base pay Change from 2023 Base pay Pascal Soriot 4.5% 1,429 4% 1,486 Aradhana Sarin 4.5% 915 4% 951 Fixed remuneration Base pay When awarding base pay increases, the Committee considers, among other factors, base pay increases applied across the UK employee population. The increase to current Executive Directors’ base pay for 2024 will increase in line with the UK all-employee base pay increase budget at 4%. 2023 2024 £’000 Pensionable base pay Pension allowance Cash in lieu of pension Pension allowance Pascal Soriot 1,429 11% of base pay 157 11% of base pay Aradhana Sarin 915 11% of base pay 101 11% of base pay Audited Pension The Executive Directors receive a pension allowance of 11% of base pay, in line with the wider UK workforce. During 2023, the Executive Directors took their pension allowance as a cash alternative to participation in a defined contribution pension scheme. Neither of the Executive Directors has a prospective entitlement to a defined benefit pension by reason of qualifying service. Audited Audited 110 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Annual Report on Remuneration continued |
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2023 Group scorecard assessment Performance against the 2023 Group scorecard is set out below. The Group scorecard is used in the determination of bonus payouts for all AstraZeneca employees. Each metric within the scorecard is assessed on a standalone basis and has a defined payout range. Performance below the specified threshold level for a metric will result in 0% payout for that metric. 100% of target bonus will pay out for on-target performance, and 200% of target bonus will pay out for performance at or above maximum. Performance between threshold and maximum is assessed on a pro rata basis. Maximum bonus payouts for the CEO and CFO for 2023 were capped at 250% and 200% of base pay respectively. The payout range for each metric is capped in line with each Executive Director’s maximum bonus opportunity to ensure underperformance against one metric cannot be compensated for by overachievement against another. The table below shows the scorecard formulaic outcomes for the CEO and CFO as a percentage of target bonus. 2023 Group scorecard performance measures and metrics Weighting Threshold (0% payout) Target (100% payout) Maximum (200% payout) Outcome Formulaic outcome (% of target bonus) Science and Innovation measures Science and Innovation: Annual pipeline progression Pipeline progression events 15% 13 25 38 30 21% Regulatory events 15% 25 35 46 46 30% Subtotal – Science and Innovation measures 30% 51% Financial measures Growth and Therapy Area Leadership Total Revenue ($bn) 30% 42.6 43.9 45.2 44.8 52% Achieve Group Financial Targets Cash flow ($bn) 20% 7.9 9.3 10.7 9.5 23% Core EPS ($) 20% 6.55 6.89 7.24 7.13 34% Subtotal – Financial measures 70% 57% Total 100% 159% Key: Bar charts are indicative of 2023 performance; scales do not start from zero. Due to rounding, the total formulaic outcome differs from the arithmetic total of the individual metric outcomes disclosed above. Pipeline progression events include Phase II starts and progressions, and NME and life-cycle management positive Phase III investment decisions. Regulatory events include NME and major life-cycle management regional submissions and approvals. Further detail on our Science and Innovation strategic priority and these events is included from page 12 of this Annual Report. Audited Annual bonus continued Directors’ Remuneration Report / Annual Report on Remuneration AstraZeneca Annual Report & Form 20-F Information 2023 111 Strategic Report Corporate Governance Financial Statements Additional Information |
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In 2023, the Growth and Therapy Area Leadership measure was based on Total Revenue. The Total Revenue and Core EPS measures are both set and evaluated at budget exchange rates at the beginning of the year and evaluated at those rates at the end of the performance period, so that any beneficial or adverse movements in currency, which are outside the Company’s control, do not impact reward outcomes. The Cash flow measure is set and evaluated at the actual exchange rate and is evaluated by reference to net cash flow from operating activities less capital expenditure, adding back proceeds from disposal of intangible assets, to be fully transparent with all elements easily derived from the Group IFRS Cash Flow Statement. Overall assessment During 2023, the Executive Directors’ individual performance was assessed in the following key areas which align with the Company’s objectives. Pascal Soriot Mr Soriot has skillfully steered AstraZeneca through another successful year. Commercial execution across all therapy areas and regions was very strong, underpinned by robust manufacturing and supply. Scientific performance in 2023 saw several significant positive read outs and regulatory approvals, including the launch of three new medicines that will contribute to the delivery of the Company’s 2030 Bold Ambition: Airsupra, Truqap and Wainua. Mr Soriot continues to lead the Company to drive Growth Through Innovation in science, with over a third of our pipeline now representing new modalities in 2023, reinforcing the transformative potential of our industry leading pipeline. Mr Soriot also oversaw the identification and signing of a number of impactful business development transactions during the year, including the licensing of a novel GLP-1 asset from Eccogene for obesity, the transaction with CinCor and proposed acquisition of Gracell Biotechnologies, which are expected to further accelerate delivery in cell therapy and oncology. Throughout 2023, Mr Soriot maintained a strong financial position for AstraZeneca, delivering yet another year of growth in revenue and profitability. The Committee also considered Mr Soriot’s leadership across other dimensions of performance: Demonstrating leadership to support developments in global life sciences Mr Soriot has continued to drive change through a diverse set of external engagements with world leaders including senior government officials from the US, Canada, China and Sweden, enhancing strategic partnerships and catalysing innovation, demonstrating his thought leadership, his ability to drive global change and his influence on key issues. He was the only private sector CEO to deliver a keynote speech at Climate Week in the presence of HM King Charles III and delivered a key note speech on Public – Private Partnerships for Healthcare Climate Action at COP28 in Dubai. He also attended both the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) where he had the opportunity to engage with the scientific community, highlighting pivotal data that strengthens our confidence that we will replace conventional chemotherapy for many patients with advanced lung and breast cancers. Leading in Environmental, Social & Governance (ESG) performance Mr Soriot continued to advocate for an uncompromising sustainability agenda at AstraZeneca exemplifying, through his leadership, the essential role of ESG within AstraZeneca’s strategy and also the important role global leaders have in the direction of global decarbonisation, demonstrated by his leadership of the SMI Health Systems; and advancing climate action through his leadership and involvement in an industry collaboration to increase renewable energy to the industry’s supply base. His efforts have been recognised at COP28 and by TIME magazine which named Mr Soriot in its inaugural TIME100 Climate. Under Mr Soriot’s leadership, in 2023 AstraZeneca has improved or maintained its position on the ESG disclosures listings we report on, including receiving a Gold score from Ecovadis (previously Silver) and a step-up in the Corporate Sustainability Assessment (CSA) position to 4th in the sector. In 2023, AstraZeneca embarked on an extensive expansion of AZ Forest including forest protection and biodiversity for a cumulative 200 million trees. It is estimated that AZ Forest will remove around 30 million tonnes of carbon dioxide from the atmosphere over 30 years, demonstrating our commitment to environmental conservation, made possible by Mr Soriot’s leadership. Healthy Heart Africa (HHA) continued to expand, launching in eight new countries. Over 43 million screenings have been conducted since the programme began, and 11,390 healthcare professionals trained. In total, over 66 million people have been reached by Access to Healthcare programmes. Making AstraZeneca a great place to work Mr Soriot has continued to highlight the importance of having a truly diverse workforce, striving to drive a business with an inclusive and equitable environment where people feel that they belong, where they feel valued for the contribution they make, and empowered to push boundaries and innovate. Our Inclusion & Diversity (I&D) strategy, “The Power of Diversity” remained a key focus with topics including Clinical Trial Diversity, Cultural Intelligence, and spotlighting the work of our Employee Resource Groups (ERGs). AstraZeneca celebrated global I&D recognition days throughout the year including International Women’s Day, Neurodiversity Celebration Week, World Day for Cultural Diversity, Pride Month, International Day of the Girl and International Day for Persons with Disabilities. Our progress was recognised externally on the 2023 Bloomberg Gender-Equality Index, Human Rights Corporation Corporate Equality Index, TIME World’s Best Companies, Forbes World’s Best Employers, Forbes World’s Top Companies for Women and Financial Times Leader in Diversity. Mr Soriot’s emphasis on leaders as coaches of our employees, and support for investments in lifelong learning has been key to providing our people with opportunities to perform, stretch, grow and take charge of their development. In 2023 AstraZeneca received several external, highly-respected awards for internal talent management programmes, including ‘Diversity by Design’ which won the Healthcare Businesswomen’s Association (HBA) Advancement. Commitment. Engagement. (ACE) Award and, alongside the Empowerment programme, also contributed to making AstraZeneca the Learning & Development winner of the Personnel Today Awards 2023. Annual bonus continued Audited 112 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Annual Report on Remuneration continued |
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Aradhana Sarin Dr Sarin continued to demonstrate her skills as a leader across the enterprise, helping to elevate a high-performance culture and driving efficiencies and simplification. Performance delivery Under Dr Sarin’s leadership, the finance function continued to deliver strong performance and made significant steps in tax planning for the future, along with debt refinancing for the business building in additional flexibility to help support future business development. Dr Sarin was personally involved in the strategic and finance review for five major business development transactions, including CinCor, Pfizer Gene Therapy Portfolio, Eccogene, Icosavax and the proposed acquisition of Gracell Biotechnologies, along with providing guidance on negotiations, resulting in attractive terms for AstraZeneca. Creating an enterprise-wide impact through Global Business Services (GBS) Under Dr Sarin’s guidance, GBS has maintained a pivotal role in AstraZeneca’s transformation. Aligned to the Future of Work, Dr Sarin has emphasised the need for simplifying, standardising, and scaling services so that AstraZeneca can deliver more medicines, faster and to more patients. Guided by Dr Sarin’s leadership, significant advances have been made creating efficiencies through clever use of new technology; the introduction of a transformational programme for data management which replaces multiple processes and uses integrated analytics that optimise process performance, and automated checks to ensure that data is right the first time; a new initiative on vendor demand which is transforming the way we search, find and buy goods and services; and an app developed and deployed which assists teams in Oncology Breast Cancer enabling them to make study co-location decisions – allowing studies to progress faster and removing complexities faced by Clinical Operations teams. All of these developments will help AstraZeneca to grow and change at speed. Great place to work/ employee engagement Dr Sarin continued to strive for increased diversity in the workplace. In June, she became the executive sponsor of AstraZeneca’s Network of Women. Dr Sarin supported several I&D recognition days including World Day for Cultural Diversity and Dialogue, International Women’s Day and International Day of the Girl, for which she hosted a discussion panel focussing on the work of the Young Health Programme in driving greater equity for women and girls around the world. Dr Sarin’s leadership style and positive influence on the team was reflected with Pulse scores showing that 90% of employees in the Finance function would recommend AstraZeneca as a great place to work and 91% believing that managers are committed to diversity and inclusion. Final determination of Executive Directors’ bonuses In determining the annual bonus outturn for Executive Directors, the Committee considers the formulaic Group scorecard outcome, as well as the overall business performance, shareholder experience and the personal contribution of the individual Executive Director. A description of the Executive Directors’ personal achievements is detailed above. Given the contributions made by both Mr Soriot and Dr Sarin in 2023 as outlined above, the Committee determined the bonus outturns for both Executive Directors should be 159% of target (or 79.5% of maximum), in line with the formulaic Group scorecard outcome. Deferred Bonus Plan (DBP) Half of each Executive Director’s pre-tax annual bonus is ordinarily deferred under the DBP. In respect of the bonus deferred, the Executive Director is granted a conditional award over shares. No further performance conditions apply to DBP shares. One half of the bonus earned in respect of performance during 2022 was deferred and details of the consequent DBP awards granted in 2023 are shown below. One half of the Executive Directors’ bonus earned in respect of performance during 2023 has been deferred and the consequent DBP awards are expected to be granted in March 2024. Audited 2023 Grant 2024 Grant Ordinary Shares granted Grant date Grant price (pence per share)1 Face value £’000 2023 Bonus deferred £’000 Pascal Soriot 14,448 4 March 2023 10821 1,563 1,420 Aradhana Sarin 7,403 4 March 2023 10821 801 728 1 The grant price is the average closing share price over the three dealing days preceding grant. 2024 Group scorecard performance measures and metrics Measure weighting Underlying metrics (if applicable) Metric weighting 2024 target Science and Innovation: Annual pipeline progression 30% Pipeline progression events 15% C Regulatory events 15% C Growth and Therapy Area Leadership 30% Total Revenue 30% C Achieve Group Financial Targets 40% Cash flow 20% C Core EPS 20% C Key Target increased vs 2023 target Target decreased vs 2023 target Target constant C Commercially sensitive Audited Annual bonus continued Audited Directors’ Remuneration Report / Annual Report on Remuneration AstraZeneca Annual Report & Form 20-F Information 2023 113 Strategic Report Corporate Governance Financial Statements Additional Information |
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Long-term incentives Long-term incentives included in the Executive Directors’ realised pay for 2023 figure: 2021 PSP The Executive Directors’ realised pay for 2023 includes the value of PSP award with performance period ended 31 December 2023. These shares and dividend equivalents will not be released to the Executive Directors’ until the awards vest at the end of the holding period. The value of the shares due to vest has been calculated using the average closing share price over the three-month period ended 31 December 2023 (10401 pence). The table below provides a breakdown showing the face value of these shares at the time they were granted, the value that is attributable to share price appreciation since grant, and the value of dividend equivalents accrued on these shares over the relevant performance period. Further information about the individual awards and performance assessments follows the table. Audited Long-term incentive awards with performance periods ended 31 December 2023 Value of shares due to vest Ordinary Shares granted Performance outcome Face value at time of grant £’000 Value due to share price appreciation1 £’000 Dividend equivalent accrued over performance period £’000 Long-term incentives total £’000 Pascal Soriot 2021 PSP 126,0462 88% 7,5913 3,946 751 12,288 Aradhana Sarin 2021 PSP 19,4144 88% 1,4025 375 116 1,893 1 Calculated using the difference between the grant price and the average closing share price over the three-month period ended 31 December 2023. The average closing share price over the three-month period ended 31 December 2023 was 10401 pence. 2 Awards were granted to Mr Soriot on 5 March 2021 and 14 May 2021, to take account of the revised limits for the PSP approved by shareholders at the Company’s 2021 AGM. 3 Calculated using the grant price of 6844 pence for the CEO’s 2021 PSP awards. 4 Dr Sarin’s award was granted on 13 August 2021, following her appointment as CFO on 1 August 2021. Her award was pro-rated to reflect that she took up the role part way through 2021. 5 Calculated using the grant price of 8209 pence, being the average closing share price over the three dealing days preceding the CFO grant. The 2021 PSP awards granted to Mr Soriot on 5 March 2021 and 14 May 2021, to take account of the revised limits for the PSP which were approved by shareholders at the Company’s 2021 AGM, are due to vest and be released on 5 March 2026 and 14 May 2026 on completion of a further two-year holding period. The 2021 PSP award was granted to Dr Sarin on 13 August 2021 following her appointment as CFO on 1 August 2021. The award made to Dr Sarin was pro-rated to reflect that she took up the role part way through 2021. Her award is due to vest on 13 August 2026 on completion of a further two-year holding period. Performance over the period from 1 January 2021 to 31 December 2023 will result in 88% of the awards vesting, based on the following assessment of performance. The 2021 PSP targets were reviewed in light of the enlarged Group following the acquisition of Alexion. The Science and Innovation, Growth and Therapy Area Leadership, Ambition Zero Carbon and Cash flow targets were all amended in line with the Committee’s approach of ensuring performance targets are not materially more or less stretching as a result of the transaction and continue to incentivise strong delivery. No amendments were made to the TSR performance measure. We intend to disclose the 2024 Group scorecard outcome and details of the performance hurdles and targets in the 2024 Directors’ Remuneration Report following the end of the performance period. The performance targets are currently considered to be commercially sensitive as prospective disclosure may prejudice the Company’s commercial interests. Executive Directors’ individual contribution will be assessed by reference to individual goals in line with the Company’s objectives for the year. Annual bonus continued Audited 114 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Annual Report on Remuneration continued |
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The Growth and Therapy Area Leadership target (measuring Total Revenue) is set at budget exchange rates at the beginning of the performance period and evaluated at those rates at the end of the performance period, so that any beneficial or adverse movements in currency, which are outside the Company’s control, do not impact reward outcomes. The Cash flow measure is assessed using cumulative net cash flow from operating activities less capital expenditure, adding back proceeds from disposal of intangible assets. For more information on Ambition Zero Carbon see page 48 and our TCFD Supplement, which is available on www.astrazeneca.com/annualreport2023. AstraZeneca ranked sixth within the TSR peer group. The TSR peer group for the 2021 PSP consisted of AbbVie, Amgen, Astellas, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Johnson & Johnson, MSD, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi and Takeda. 2021 PSP performance measures and metrics1 Weighting Threshold (20% vesting) Maximum (100% vesting) Outcome Payout Science and Innovation: First approvals and NME volume over three years NME Phase III/registrational volume 12% 9 18 16 11% Regulatory events 18% 13 26 24 17% Subtotal – Science and Innovation2 30% 28% Growth and Therapy Area Leadership ($bn) 20% 40.5 47.5 49.0 20% Cash flow ($bn) 20% 19.0 27.0 25.0 18% Total shareholder return 20% Median UQ3 6th 14% Ambition Zero Carbon 10% 272 ktCO2e 220 ktCO2e 207.4ktCO2e 10% Total2 100% 88% Key: Bar charts are indicative of 2021 PSP performance; scales do not start from zero. Due to rounding, the total outcome differs from the arithmetic total of the individual metric outcomes disclosed above 1 The Committee reviewed the 2021 PSP targets following the acquisition of Alexion to reflect the impact of the acquisition on the Company’s results. The Committee is confident that the increases applied to the targets during that review ensured that they remained ambitious and stretching. The Company does not intend to disclose the original Growth and Therapy Area Leadership target, set prior to the acquisition, as the adjustment to the target relates to a single disease area (Rare Disease), which is therefore commercially sensitive. The other original targets were disclosed in the Company’s annual report for the year ended 31 December 2020. 2 The subtotal and total reflect the weightings of the individual metrics. 3 UQ = Upper Quartile. PSP awards granted during 2023 During 2023, conditional awards of shares were granted to the Executive Directors with face values equivalent to 650% of base pay for Mr Soriot and 450% of base pay for Dr Sarin under the PSP. Face value is calculated using the grant price, being the average closing share price over the three dealing days preceding grant. Performance will be assessed over the period from 1 January 2023 to 31 December 2025 against the measures outlined below to determine the proportion of the award that vests. A further two-year holding period will then apply before vesting, which is scheduled to occur on the fifth anniversary of grant. Ordinary Shares granted Grant date Grant price (pence per share)1 Face value £’000 End of performance period End of holding period Pascal Soriot 85,808 4 March 2023 10821 9,285 31 December 2025 4 March 2028 Aradhana Sarin 38,046 4 March 2023 10821 4,117 31 December 2025 4 March 2028 1 The grant price is the average closing share price over the three dealing days preceding grant. The 2023 PSP performance measures focus on scientific, ESG, commercial and financial performance over the three-year performance period. The five performance metrics attached to the 2023 PSP awards are detailed below. Twenty per cent of the award will vest if the threshold level of performance is achieved; the maximum level of performance must be achieved under each measure for 100% of the award to vest. Relative total shareholder return (TSR) (20% of award) TSR performance is assessed against a predetermined peer group of global pharmaceutical companies and consists of AbbVie, Amgen, Astellas, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck KGaA, Moderna, MSD, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi and Takeda. The rank which the Company’s TSR achieves over the performance period will determine how many shares will vest under this measure. TSR ranking of the Company % of award that vests Median 20% (threshold for payout) Between median and upper quartile Pro rata Upper quartile 100% Long-term incentives Audited Directors’ Remuneration Report / Annual Report on Remuneration AstraZeneca Annual Report & Form 20-F Information 2023 115 Strategic Report Corporate Governance Financial Statements Additional Information |
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Net Cash flow (20% of award) The Cash flow measure is assessed using cumulative net cash flow from operating activities less capital expenditure adding back proceeds from disposal of intangible assets. The level of vesting under this measure is based on a scale between a threshold target and an upper target. Cash flow % of award that vests $22.0bn 20% (threshold for payout) Between $22.0bn and $26.0bn Pro rata $26.0bn 75% Between $26.0bn and $31.0bn Pro rata $31.0bn and above 100% Growth and Therapy Area Leadership (20% of award) For PSP awards granted in 2023, the Growth and Therapy Area Leadership metric is Total Revenue. Disclosing the threshold and maximum hurdles for this measure could be construed to constitute financial guidance, which is not the Company’s intention. The Growth and Therapy Area Leadership (Total Revenue) measure is thus considered to be commercially sensitive and will be disclosed following the end of the performance period, in the 2025 Directors’ Remuneration Report. This measure is evaluated by reference to budget exchange rates. Science and Innovation: First approvals and NME volume over three years (30% of award) Performance is assessed using dual indices which measure NME Phase III/registrational volume and regulatory events, allowing disclosure of targets at the beginning of the performance period. NME Phase III/registrational volume (12% of award) % of award that vests Regulatory events (18% of award) % of award that vests 10 20% (threshold for payout) 13 20% (threshold for payout) Between 10 and 15 Pro rata Between 13 and 20 Pro rata 15 75% 20 75% Between 15 and 20 Pro rata Between 20 and 26 Pro rata 20 100% 26 100% Ambition Zero Carbon (10% of award) This measure reflects the importance of eliminating greenhouse gas (GHG) emissions from our Scope 1 and Scope 2 operations through 2025. Reductions are measured against our 2015 baseline, and calculated in line with the World Resources Institute/World Business Council for Sustainable Development GHG Protocol methodology for accounting and reporting of our emissions footprint. Emissions % of award that vests 142 ktCO2e 20% (threshold for payout) Between 142 ktCO2e and 116 ktCO2e Pro rata 116 ktCO2e 75% Between 116 ktCO2e and 91 ktCO2e Pro rata 91 ktCO2e and below 100% Audited Long-term incentives continued 116 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Annual Report on Remuneration continued |
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Long-term incentives continued PSP performance measures for 2024 grant The 2024 PSP measures remain unchanged from the 2023 PSP award. PSP performance measure Measure weighting Underlying metrics (if applicable) Metric weighting Threshold (20% vesting) Maximum (100% vesting) Science and Innovation: First approvals and NME volume over three years 30% NME Phase III/registrational volume 12% 14 28 Regulatory events 18% 16 32 Growth and Therapy Area Leadership 20% Total Revenue Commercially sensitive until end of performance period Cash flow 20% $23.0bn $33.0bn Relative TSR 20% Median Upper Quartile Ambition Zero Carbon 10% 26 ktCO2e 13 ktCO2e Regulatory events measure NME and major life-cycle management approvals (taking into account the first approval over the performance period). NME Phase III/registrational volume measures the total NME pipeline volume at the end of the performance period. These two items ensure that management is assessed on both R&D late-stage delivery (approvals) and also future pipeline sustainability (volume). Disclosing the threshold and maximum hurdles for the Growth and Therapy Area Leadership (Total Revenue) measure could be construed to constitute financial guidance, which is not the Company’s intention. The Total Revenue measure is thus considered to be commercially sensitive and will be disclosed following the end of the performance period. The Total Revenue measure is evaluated by reference to budget exchange rates such that beneficial or adverse movements in currency, which are outside the Company’s control, do not impact reward outcomes. The Cash flow measure is evaluated using net cumulative cash flow from operating activities less capital expenditure adding back proceeds from disposal of intangible assets. The companies in the TSR comparator group are shown on page 125. The Cash flow measure is assessed using cumulative net cash flow from operating activities less capital expenditure adding back proceeds from disposal of intangible assets. Capital expenditure is expected to increase by more than 50% during the performance period, driven by investment in several major manufacturing capabilities such as API, inhaled products, monoclonal antibodies and cell therapy. Our Ambition Zero Carbon measure is based on our Scope 1 and Scope 2 emissions reductions from our 2015 baseline. Further detail on our commitment can be found on page 148. As described on page 107, the Committee takes into account a wide range of data to ensure that the stretching nature of PSP hurdles is robustly tested and that financial targets are aligned with the Company’s Mid-Term Plan. The Committee takes consensus and exchange rates into account when determining the appropriate level of stretch. PSP awards are expected to be granted to the Executive Directors in March 2024. The PSP award to be granted to Dr Sarin will be equivalent to 550% of base pay. The PSP award to be granted to Mr Soriot will be equivalent to 650% of base pay. Subject to the approval of our proposed Directors’ Remuneration Policy and amended rules of the PSP at the Company’s AGM on 11 April 2024, a further PSP award will be granted to Mr Soriot equivalent to 200% of base pay, bringing Mr Soriot’s total PSP award for 2024 in line with the maximum opportunity under the Policy. For more information about How our performance measures for 2024 support the delivery of our strategy, and How the Remuneration Committee ensures targets are stretching, see pages 107 and 108. Directors’ Remuneration Report / Annual Report on Remuneration AstraZeneca Annual Report & Form 20-F Information 2023 117 Strategic Report Corporate Governance Financial Statements Additional Information |
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Non-Executive Directors’ realised pay for 2023 (single total figure of remuneration) The table sets out all elements of remuneration receivable by the Non-Executive Directors in respect of the year ended 31 December 2023, alongside comparative figures for the prior year. 2023 Fees £’000 2022 Fees £’000 2023 Other £’000 2022 Other £’000 2023 Total £’000 2022 Total £’000 Michel Demaré1 584 158 – – 584 158 Euan Ashley 119 110 – – 119 110 Philip Broadley 200 200 – – 200 200 Deborah DiSanzo 120 120 – – 120 120 Diana Layfield 110 110 – – 110 110 Anna Manz 40 – – – 40 – Sheri McCoy 175 157 – – 175 157 Tony Mok 110 110 – – 110 110 Nazneen Rahman 160 155 – – 160 155 Andreas Rummelt 110 110 – – 110 110 Marcus Wallenberg 125 125 – – 125 125 Former Non-Executive Directors Leif Johansson – retired 27 April 2023 203 625 22 70 225 695 Total 2,056 1,980 22 70 2,078 2,049 1 Michel Demaré was appointed Chair of the Board from 27 April 2023. Leif Johansson retired from the Board on 27 April 2023. Mr Johansson’s single total figure includes office costs (invoiced in Swedish kronor) of £21,955 for the period in 2023 during which he was Chair of the Board and £69,524 for 2022. From 1 May 2023, the Chair of the Board did not receive office costs. Non-Executive Directors’ fee structure The Non-Executive Directors’ fees effective from January 2024 are set out in the table below, alongside the fees applicable during 2023. Fees for the Non-Executive Directors (other than the Chair of the Board) are determined by the Chair and the Executive Directors. No Board member participated in any decisions relating to their own fees. The fee structure is reviewed, but not necessarily increased every two years. The Non-Executive Directors’ fees have not been increased since January 2022. The Chair’s fee was separately reviewed in July 2022 and increased with effect from May 2023. It is next due for review in 2024. With effect from January 2024, increases have been made to the basic Board fee for Non-Executive Directors (excluding the Chair), the senior independent Non-Executive Director’s fee, the Chairs’ fees for Board Committees (excluding the Nomination and Governance Committee in respect of which no additional fees are paid), as well as the fees for membership of the Science Committee and the Sustainability Committee. In the latest review, the overall size and complexity of the AstraZeneca Group was considered, together with the continuing increase in workload, responsibilities, and time commitment for non-executive directors of global, publicly listed companies, in part driven by changes in the corporate governance and regulatory landscape in multiple jurisdictions. The fees for the Chairs of the Science Committee and the Sustainability Committee, as well as membership fees for these Committees, have been increased to reflect the contribution of these Committees to the sustained future growth of the Company. The latest review also considered independently-sourced market data for FTSE 30 and FTSE 10 companies, to ensure that the level of AstraZeneca’s fees do not hinder the recruitment of Directors of the right experience and calibre for a Group of our scale in a global market. Non-Executive Director fees 2023 £’000 2024 £’000 Chair of the Board1 8002 800 Basic Non-Executive Director 95 115 Senior independent Non-Executive Director 40 48 Member of the Audit Committee 25 25 Chair of the Audit Committee3 45 50 Member of the Remuneration Committee 20 20 Chair of the Remuneration Committee3 40 45 Member of the Sustainability Committee 15 20 Chair of the Sustainability Committee3 30 45 Member of the Science Committee 15 20 Chair of the Science Committee3 30 45 1 The Chair of the Board does not receive any additional fees for chairing, or being a member of a Committee. 2 The fee for the Chair of the Board increased to £800,000 per annum with effect from 1 May 2023 as announced in July 2022. 3 The Committee Chairs do not receive additional fees for being a member of the Committee. Audited Non-Executive Directors’ remuneration 118 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Annual Report on Remuneration continued |
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Directors’ shareholdings Position against the 2023 minimum shareholding requirement (MSR) as a percentage of base pay Beneficially owned shares and shares in a holding period1 Shares in deferral period2 Shares subject to performance conditions Value of shares counted towards MSR as a % of base pay3 Pascal Soriot 363,489 48,608 308,920 2,130% Aradhana Sarin 82,514 10,652 100,498 1,018% 1 Holding period shares included are those which are not subject to continued employment. 2 Shares in deferral periods which are subject to continued employment. 3 Holding as at 31 December 2023. Shares subject to deferral and holding periods calculated net of a theoretical 50% tax rate. Shares subject to performance conditions are not included in the value of shares counted towards MSR. Audited Audited Minimum shareholding requirements The CEO and CFO are each required to build a shareholding to satisfy their respective minimum shareholding requirements (MSR), each within five years of their dates of appointment or, if the MSR is increased at any time, within five years of that increase. The MSR for 2023 are set out below. Shares that count towards the MSR are shares beneficially held by the Executive Director and their connected persons and share awards that are not subject to further performance conditions. Share awards included are DBP shares in deferral periods, and PSP and AstraZeneca Investment Plan (AZIP) shares in holding periods, on a net-of-tax basis. A further post-employment shareholding requirement applies to Executive Directors. For two years following cessation of employment, Executive Directors are required to hold shares to the value of the shareholding requirement that applied at the cessation of their employment; or, in cases where the individual has not had sufficient time to build up shares to meet their guideline, the actual level of shareholding at cessation. The post-cessation requirement will be maintained through self-certification, with the Committee keeping this approach under review. Non-Executive Directors are encouraged to build up, over a period of three years, a shareholding in the Company with a value approximately equivalent to the basic annual fee for a Non-Executive Director (£95,000 during 2023) or, in the case of the Chair, approximately equivalent to his basic annual fee (£800,000 during 2023). All Non-Executive Directors who had served for a period of three years or more as at 31 December 2023 met this expectation, based on the three-month average closing share price for the period ended 31 December 2023 (10,401 pence). Directors’ interests as at 31 December 2023 The following table shows the beneficial interests of the Directors (including the interests of their connected persons) in Ordinary Shares as at 31 December 2023. Executive Directors Beneficial interest in Ordinary Shares at 31 December 20231 Beneficial interest in Ordinary Shares at 31 December 20221 Pascal Soriot 363,489 248,855 Aradhana Sarin 82,514 70,154 Non-Executive Directors Leif Johansson2 39,009 39,009 Michel Demaré3 6,000 2,000 Euan Ashley 1,150 1,150 Philip Broadley 7,045 7,045 Deborah DiSanzo 1,000 1,000 Diana Layfield 1,400 1,400 Anna Manz4 487 n/a Sheri McCoy 1,736 1,736 Tony Mok 2,000 2,000 Nazneen Rahman 1,017 1,017 Andreas Rummelt 27,205 27,205 Marcus Wallenberg 60,028 60,028 1 For the Executive Directors, beneficial interests include shares in holding periods which are not subject to performance measures or continued employment. Shares in a holding period are included on a gross basis. 2 Leif Johansson’s beneficial interests are shown as at 27 April 2023, when he retired as Chair of the Board. 3 Michel Demaré was appointed Chair of the Board on 27 April 2023. 4 Anna Manz was appointed on 1 September 2023. Key: 2023 MSR Shares counted towards MSR 2,130% 1,018% 650% CEO 450% CFO Further information on the Non-Executive Directors’ fee structure can be found within the current Remuneration Policy on the Company’s website, www.astrazeneca.com. Directors’ Remuneration Report / Annual Report on Remuneration AstraZeneca Annual Report & Form 20-F Information 2023 119 Strategic Report Corporate Governance Financial Statements Additional Information |
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Directors’ shareholdings continued Executive Directors’ share plan interests The following tables set out the Executive Directors’ interests in Ordinary Shares under the Company’s share plans. Pascal Soriot Shares outstanding at 31 December 2023 Share scheme interests Grant date Shares outstanding at 1 January 2023 Grant price (pence) Shares granted in year Shares released in year Shares lapsed in year Shares subject to performance Shares in deferral/ holding period Performance period end Vesting and release date DBP 06/03/2020 8,734 7376 – 8,734 – n/a – n/a 06/03/20231,2 05/03/2021 16,944 6844 – – – n/a 16,944 n/a 05/03/2024 04/03/2022 17,216 9154 – – – n/a 17,216 n/a 04/03/2025 04/03/2023 – 10821 14,448 – – n/a 14,448 n/a 04/03/20263 PSP 23/03/2018 127,600 4853 – 127,600 – – – 31/12/2020 23/03/20234,5 08/03/2019 97,351 6287 – – – – 97,351 31/12/2021 08/03/2024 06/03/2020 87,346 7376 – – 2,621 – 84,725 31/12/2022 06/03/20256 21/05/2020 8,734 7376 – – 263 – 8,471 31/12/2022 21/05/20256 05/03/2021 106,655 6844 – – – 106,655 – 31/12/2023 05/03/2026 14/05/2021 19,391 6844 – – – 19,391 – 31/12/2023 14/05/2026 04/03/2022 97,066 9154 – – – 97,066 – 31/12/2024 04/03/2027 04/03/2023 – 10821 85,808 – – 85,808 – 31/12/2025 04/03/20287 AZIP 27/03/2015 13,095 4762 – 13,095 – – – 31/12/2018 01/01/20238,9 24/03/2016 10,809 3923 – – – – 10,809 31/12/2019 01/01/2024 Total 610,941 100,256 149,429 2,884 308,920 249,964 1 Market price on 6 March 2023, the actual date of release, was 10784 pence. 2 An additional 661 Ordinary Shares were released as a result of the reinvestment of dividend equivalents accrued during the deferral period. 3 Award granted following deferral of one half of the annual bonus earned in respect of performance during 2022, see page 113 for further detail. 4 Market price on 23 March 2023, the actual date of release, was 10976 pence. 5 An additional 17,092 Ordinary Shares were released as a result of the reinvestment of dividend equivalents accrued during the performance and holding period. 6 97% of the shares entered the holding period, following assessment of performance over the period to 31 December 2022. The remaining shares lapsed. 7 Details of PSP awards granted during 2023 are shown on page 115. 8 Market price on 9 February 2023, the actual date of release, was 10752 pence. 9 An additional 3,046 Ordinary Shares were released as a result of the reinvestment of dividend equivalents accrued during the performance and holding period. Aradhana Sarin Shares outstanding at 31 December 2023 Share scheme interests Grant/ conversion date Shares outstanding at 1 January 2023 Grant price (pence) Shares granted in year Shares released in year Shares lapsed in year Shares subject to performance Shares in deferral/ holding period Performance period end Vesting and release date Alexion incentive shares1 21/07/2021 4,290 – 4,290 – n/a – n/a 01/02/20232 21/07/2021 9,649 – 9,649 – n/a – n/a 01/02/20232 21/07/2021 9,649 – 9,649 – n/a – n/a 01/02/20232 RSU award3 13/08/2021 12,276 8209 – 12,276 – n/a – n/a 01/02/20234,5 DBP 04/03/2022 3,249 9154 – – – n/a 3,249 n/a 04/03/2025 04/03/2023 – 10821 7,403 – – n/a 7,403 n/a 04/03/20266 PSP 13/08/2021 19,414 8209 – – – 19,414 – 31/12/2023 13/08/2026 04/03/2022 43,038 9154 – – – 43,038 – 31/12/2024 04/03/2027 04/03/2023 – 10821 38,046 – – 38,046 – 31/12/2025 04/03/20287 Total 101,565 45,449 35,864 0 100,498 10,652 1 The number shown is the number of Ordinary Shares underlying the American Depositary Receipts (ADRs). Two ADRs are equivalent to one Ordinary Share. Awards made to replace Dr Sarin’s Alexion incentive share awards, which were outstanding at the time of the Alexion acquisition, were done so on the same basis as other participants. The outstanding in-flight awards were converted to awards over AstraZeneca ADRs in accordance with the terms of the Merger Agreement, using the average of the volume-weighted averages of the trading price of AstraZeneca ADRs on the Nasdaq from 13 July to 19 July 2021 inclusive ($58.2622). The face value of the converted awards was $17.8 million. 2 Market price of AstraZeneca ADRs on 9 February 2023, the actual date of release, was $64.36. 3 One-off restricted share award granted to Dr Sarin to compensate her for the forfeiture of her previous contractual severance right entitlements. 4 Market price of Ordinary Shares on 9 February 2023, the actual date of release, was 10572 pence. 5 An additional 286 Ordinary Shares were released as a result of the reinvestment of dividend equivalents accrued during the vesting period. 6 Award granted following deferral of one half of the annual bonus earned in respect of performance during 2022, see page 113 for further detail. 7 Details of PSP awards granted during 2023 are shown on page 115. No Director or senior executive beneficially owns, or has options over, 1% or more of the issued share capital of the Company, nor do they have different voting rights from other shareholders. None of the Directors has a beneficial interest in the shares of any of the Company’s subsidiaries. Between 31 December 2023 and 8 February 2024, there was no change in the interests in Ordinary Shares for current Directors shown in the table above. Audited 120 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Annual Report on Remuneration continued |
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Payments to former Directors Marc Dunoyer was granted a PSP award in 2021, whilst in the position of CFO and Executive Director of AstraZeneca PLC. Mr Dunoyer stepped down as an Executive Director on 1 August 2021, part way through the 2021 PSP performance period, but remained a member of the SET. Consistent with other participants in the PSP, performance over the period 1 January 2021 to 31 December 2023 will result in 88% of Mr Dunoyer’s award granted in 2021 vesting on completion of a further two-year holding period. This represents 8,868 shares vesting when pro-rated to reflect the performance period during which Mr Dunoyer was an Executive Director (1 January 2021 to 1 August 2021). Payments for loss of office During 2023, no payments were made to Directors for loss of office. Remuneration in the wider context In our Corporate Governance Report on page 81, we explain in detail how the Board has chosen to engage with AstraZeneca’s workforce, and how important engagement with our employees is if we are to be a great place to work and continue to deliver outstanding performance. The Directors believe that the Board as a whole should continue to take responsibility for gathering the views of the workforce. Consequently, instead of implementing one of the three methods for workforce engagement prescribed in the 2018 UK Corporate Governance Code, the Board chose to enhance and develop the long-standing channels of engagement which already exist in the organisation to ensure that the Board continues to understand the global workforce’s views on a wide variety of topics, including matters relating to remuneration. The Committee communicates with, and receives feedback from, employees through a variety of channels, including meetings with high-potential employees and attending site visits, both virtually and in person. This allows the Committee to communicate with employees on remuneration matters where appropriate. Committee members review wide-ranging data on reward across our global workforce, as well as broader information on workforce trends and culture, which is also provided to the full Board. The Committee receives in-depth reports throughout the year on colleague pay, benefits, incentives, performance management approach and broader talent policies at AstraZeneca to ensure that the Committee is informed of wider workforce remuneration when making executive pay decisions. Decisions of the Committee affecting employees, such as the annual Group scorecard outcomes, are shared with employees through internal communications as well as through the Directors’ Remuneration Report. Additionally, we publish materials on executive remuneration and its implementation for employees on our intranet site. In the event that more significant changes to workforce remuneration are proposed, active engagement with employee representative groups provides feedback to help the Committee understand the impact upon the broader workforce. When reviewing executive remuneration, the Committee takes into consideration our global workforce, looking to ensure the global total reward offering is competitive, compelling and aligned to our business performance, while supporting a culture where everyone feels valued and included, as outlined in the table on page 122. People and Sustainability is one of our three strategic priorities, and we explain in our Business Review from page 43 the role that reward plays in developing a diverse culture that encourages and rewards innovation, entrepreneurship and high performance. In carrying out its responsibilities and when setting the Policy, the Committee has taken into account the principles of the UK Corporate Governance Code and the factors outlined within Provision 40 as described in the table below. Area Our approach Clarity Remuneration arrangements should be transparent and promote effective engagement with shareholders and the workforce. The Committee believes the remuneration structures under both the current and proposed Directors’ Remuneration Policy, and those for the wider workforce as set out below, are clearly understood. The Committee regularly engages with employees and shareholders and considers their feedback when reviewing the Directors’ Remuneration Policy and implementation. Simplicity Remuneration structures should avoid complexity and their rationale and operation should be easy to understand. We operate a simple remuneration framework for our executives across both fixed and variable pay which is, where possible, aligned with the wider workforce. The purpose, structure and strategic alignment of each element of pay has been clearly laid out in our Directors’ Remuneration Policy. Risk Remuneration arrangements should ensure reputational and other risks from excessive rewards, and behavioural risks that can arise from target-based incentive plans, are identified and mitigated. We seek to ensure alignment with long-term shareholder interests and to mitigate any potential risk through several mechanisms within our approach to executive remuneration. These include the two-year holding period under the PSP on vesting, 50% mandatory deferral into shares for three years for any annual bonus award, operation of malus and clawback provisions as summarised in our Directors’ Remuneration Policy, and a shareholding requirement for two years post-cessation of employment. Predictability The range of possible values of rewards to individual directors and any other limits or discretions should be identified and explained at the time of approving the Policy. The Committee set out under the proposed Directors’ Remuneration Policy (and our current Policy approved in May 2021) the range of possible values under specific performance scenarios. Proportionality The link between individual awards, the delivery of strategy and the long-term performance of the company should be clear. Outcomes should not reward poor performance. As set out on page 108, the Committee follows a robust target-setting and assessment process to ensure variable pay outcomes under the annual bonus and PSP are proportional to our wider performance. Our Directors’ Remuneration Policy operated as intended in terms of Company performance and quantums during 2023, supporting the delivery of our strategy and another exceptional year for AstraZeneca. Alignment to culture Incentive schemes should drive behaviours consistent with company purpose, values and strategy. The Committee believes that the remuneration structures in place are aligned to the Company’s performance culture and values and ensure the successful delivery of our strategy, with alignment between strategy and reward set out on page 107. For example, alongside the formulaic outcome, our annual bonus scheme for Executive Directors includes a holistic assessment of their performance and broader ESG factors, further reinforcing the importance of our Purpose and Values. Audited Directors’ Remuneration Report / Annual Report on Remuneration AstraZeneca Annual Report & Form 20-F Information 2023 121 Strategic Report Corporate Governance Financial Statements Additional Information |
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Summary of remuneration structure for employees below the Board Element Policy features for the wider workforce Comparison with Executive Director and Senior Executive Team (SET) remuneration Base pay Our base pay is the basis for a competitive total reward package for all employees, and we review base pay annually. This review takes account of country budget, relevant market comparators, the skills, capabilities, knowledge and experience of each individual, relative to peers within the Company, and individual contribution. In setting the budget each year, we consider affordability as well as assessing how employee base pay is currently positioned relative to inflation, market rates, forecasts of any further market increases, and turnover. The base pay of our Executive Directors and SET forms the basis of their total remuneration, and we review their base pay annually. The primary purpose of the review is to ensure base pay remains competitive and reflects the contribution each individual makes to the organisation. Pensions and benefits We offer market-aligned wellbeing benefit packages reflecting market practice in each country in which we operate. Where appropriate, we offer elements of personal benefit choice to our employees. The benefit packages of our Executive Directors and SET are broadly aligned with the wider workforce of the country in which they are employed. Pension allowances for current UK Executive Directors are in line with the wider UK workforce. Annual bonus With the exception of our sales representatives receiving sales-related incentives, our global workforce participates in the same annual cash bonus plan as the Executive Directors and SET, with the same Group scorecard performance measures outlined on page 111. Achievement against the scorecard creates a bonus pool from which all awards are made. For employees within our commercial organisation, the country-level share of the global bonus pool also takes into account country performance against KPIs. Individual outcomes are based on manager assessment of contribution against individual objectives and peers. Awards are based on a 0-200% target range. The ranges for Executive Directors and the SET align with the wider workforce at 0-200% of target. Half of any award to an Executive Director under the plan is subject to deferral into shares subject to a three-year holding period. One sixth of any award to the SET under the plan is deferred into shares subject to a three-year holding period. Long-term incentives The PSP is operated with a three-year performance period for employees at Vice-President and Senior Vice-President level, with the same performance measures that apply to Executive Director and SET PSP awards (outlined from page 115). A proportion of our workforce below this level is eligible to be considered for other long-term incentive awards, such as restricted stock awards. 35% of our global employee population are eligible to receive an award under our Long-term incentive plans. PSP awards to Executive Directors and the SET are granted under the same plan as PSP awards granted to Vice-Presidents and Senior Vice-Presidents. PSP awards to Executive Directors and the SET are subject to a two-year holding period following the three-year performance period. 122 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Annual Report on Remuneration continued |
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Change in Director remuneration compared to other employees In the table below, as per the requirements of the Companies (Directors’ Remuneration Policy and Directors’ Remuneration Report) Regulations 2019, changes to the base pay (or fees), taxable benefits and annual bonus of Directors are compared to employees for the previous financial year. The regulations require comparison between the remuneration of each Director and that of all employees of the parent company on a full-time equivalent basis. As AstraZeneca PLC has no direct employees, and in line with our disclosure approach in prior years to changes in employee remuneration, the selected comparator group is comprised of employees in the UK, US and Sweden who represent approximately 40% of our total employee population. We consider that this group is representative of the Group’s major science, business and enabling units. These employee populations are also well balanced in terms of seniority and demographics. Change in 2023 against 2022 (%) Change in 2022 against 2021 (%) Change in 2021 against 2020 (%) Change in 2020 against 2019 (%) Base pay/fees Benefits Annual bonus Base pay/fees Benefits Annual bonus Base pay/fees Benefits Annual bonus Base pay/fees Benefits Annual bonus Executive Directors Pascal Soriot 4.5 3.1 -9.2 3.0 10.5 -0.8 3.0 1.1 35.9 0.0 -2.7 20.0 Aradhana Sarin1 4.5 -71.6 -9.2 147.2 2,753.2 169.3 – – – – – – Non-Executive Directors Leif Johansson2 -67.5 -216.7 – 0.0 -6.4 – 0.0 1.4 – 0.0 1.4 – Michel Demaré3 268.9 – – 7.0 – – 18.7 – – 247.2 – – Euan Ashley4 8.0 – – 6.8 – – 300.0 – – – – – Philip Broadley 0.0 – – 15.6 – – 16.9 – – 2.8 – – Deborah DiSanzo 0.0 – – 11.1 – – 0.0 – – 0.0 – – Diana Layfield5 0.0 – – 19.9 – – 525.6 – – 0.0 – – Anna Manz6 – – – – – – – – – – – – Sheri McCoy 11.7 – – 23.6 – – 3.0 – – 0.0 – – Tony Mok 0.0 – – 6.8 – – 0.0 – – 0.0 – – Nazneen Rahman 3.0 – – 18.2 – – 11.0 – – 0.0 – – Andreas Rummelt7 0.0 – – 172.2 – – – – – – – – Marcus Wallenberg 0.0 – – 17.1 – – 3.6 – – 0.0 – – Employees 7.0 7.0 3.2 6.0 6.0 19.3 4.9 4.9 44.4 4.1 4.1 -11.6 1 Aradhana Sarin joined the Board of AstraZeneca PLC on 1 August 2021. Percentage changes are based on the totals reported on page 109. 2 Benefits for Leif Johansson are office costs. Mr Johansson retired from the Board on 27 April 2023. 3 Michel Demaré was appointed Chair of the Board on 27 April 2023. 4 Euan Ashley was appointed on 1 October 2020. 5 Diana Layfield was appointed on 1 November 2020. 6 Anna Manz was appointed on 1 September 2023. 7 Andreas Rummelt was appointed on 1 August 2021. Directors’ Remuneration Report / Annual Report on Remuneration AstraZeneca Annual Report & Form 20-F Information 2023 123 Strategic Report Corporate Governance Financial Statements Additional Information |
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Remuneration in the wider context continued CEO and employee pay ratios The table below sets out the ratios of the CEO’s realised pay to the equivalent pay for the lower quartile, median and upper quartile UK employees (calculated on a full-time equivalent basis). The ratios have been calculated in accordance with the Companies (Miscellaneous Reporting) Regulations 2018 (the Regulations). Year Method 25th percentile pay ratio 50th percentile pay ratio 75th percentile pay ratio 2023 Option A 271:1 182:1 121:1 2022 Option A 230:1 159:1 107:1 2021 Option A 240:1 162:1 106:1 2020 Option A 284:1 197:1 130:1 2019 Option A 280:1 190:1 123:1 2018 Option A 230:1 160:1 103:1 The comparison with UK employees is specified by the Regulations. This group represents approximately 12% of our total employee population. The Regulations provide flexibility to adopt one of three methods of calculation; we continue to use Option A which is a calculation based on all UK employees on a full-time equivalent basis as we consider this to be the most appropriate method of comparison and in line with the calculation of CEO’s realised pay (shown on page 109 for 2023). The ratios are based on total pay, which includes base pay, benefits, bonus and Long-term incentive (LTI) awards with all elements adjusted on a full-time equivalent basis if required. Our calculations are in line with the single figure methodology for UK employees where possible, with quartile data determined as at 31 December 2023. Calculations for UK employees are based on actual base pay and benefits data for the year, with estimates only used for annual bonus outcomes and LTI dividend equivalents. These estimates are based on the 2023 bonus budget and projected payouts, and anticipated dividends on LTI awards, respectively. No elements of pay have been excluded from the calculation, which has been determined following the approach of previous years. CEO UK employees 25th percentile 50th percentile 75th percentile Pay data1 (£’000) Base pay Total pay Base pay Total pay Base pay Total pay Base pay Total pay 2023 1,429 16,853 46 62 65 92 88 139 2022 1,367 15,323 48 67 67 96 88 143 2021 1,327 13,858 43 58 61 86 86 130 2020 1,289 15,447 41 54 60 78 82 119 2019 1,289 14,330 38 51 53 75 71 117 2018 1,251 11,356 36 49 50 71 70 110 1 The prior years’ figures have not been restated for subsequent share price changes (as shown in the CEO realised pay for 2023 table on page 109). The pay ratios at each quartile were higher in 2023 when compared to last year, due to a combination of significant share price appreciation over the performance period of the CEO’s 2021 Performance Share Plan award (representing 23% of the overall single figure), which was granted at a higher face value than the 2020 award (650% of base pay versus 550%), and a lower overall bonus pool for employees in 2023 based on Scorecard performance impacting total pay. Given the Committee’s focus on ensuring CEO pay is performance-driven (and as demonstrated again this year), the majority of the single figure is comprised of variable pay and therefore may vary significantly year-on-year due to annual bonus and PSP outcomes, as well as share price movements. The Committee therefore also considers the CEO pay ratio without the LTI impact. When excluding LTI, the pay ratio of the CEO compared to the median UK employee is 52:1 – in line with the trend across prior years. 2018 2019 2020 2021 2022 2023 50th percentile ratio excluding LTI 51:1 51:1 53:1 57:1 51:1 52:1 The Committee remains mindful of the debate on executive pay and seeks to ensure that when determining the remuneration of the CEO it finds the right balance when rewarding performance in a highly competitive global executive talent market. It believes the median ratio is consistent with the pay and progression policies for UK employees, which ensures our total reward offering is competitive and compelling, and aligned to individual and business performance as set out on page 121. Relative importance of spend on pay The table below shows the remuneration paid to all employees in the Group, including the Executive Directors, and expenditure on shareholder distributions through dividends. The figures have been calculated in accordance with the Group Accounting Policies and drawn from either the Group’s Consolidated Statement of Comprehensive Income on page 148, or its Consolidated Statement of Cash Flows on page 151. Further information on the Group’s Accounting Policies can be found from page 152. 2023 2022 Difference in spend between years $m Difference in spend between years % Total employee remuneration 12,335 11,531 804 7 Distributions to shareholders: dividends paid 4,481 4,364 117 3 124 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Annual Report on Remuneration continued |
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Total shareholder return (TSR) The graph below compares the TSR performance of the Company over the past 10 years with the TSR of the FTSE 100 Index and our global pharmaceutical peers. This graph is re-based to 100 at the start of the relevant period. These indices represent appropriate reference points for AstraZeneca reflecting our primary listing as a constituent of the FTSE 100 and a comparison against our global pharmaceutical peers. The pharmaceutical comparator group is also used to assess relative TSR performance for PSP awards to be granted in 2024 and consists of AbbVie, Amgen, Astellas, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck KGaA, Moderna, MSD, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi and Takeda. CEO remuneration over the same 10-year period is shown after the TSR graph. TSR over a 10-year period AstraZeneca Global pharmaceutical peers average FTSE 100 Dec 13 Dec 14 Dec 15 Dec 16 Dec 17 Dec 18 Dec 19 Dec 20 Dec 21 Dec 22 Dec 23 500 400 300 200 100 CEO total remuneration table Year CEO CEO realised pay £’000 Annual bonus payout against maximum opportunity % LTI vesting rates against maximum opportunity % 2023 Pascal Soriot 16,8531 79.5 88 2022 Pascal Soriot 15,0852 92 97 2021 Pascal Soriot 15,740 95 95 2020 Pascal Soriot 15,934 90 99 2019 Pascal Soriot 15,307 83 90 2018 Pascal Soriot 12,868 83 79 2017 Pascal Soriot 10,429 87 81 2016 Pascal Soriot 14,3423 54 95 2015 Pascal Soriot 7,963 97 78 2014 Pascal Soriot 3,507 94 – 1 The 2023 realised pay is shown on page 109. 2 This figure has been revised using the average closing share price over the three-month period to 31 December 2023, as explained on page 109. 3 This figure includes shares awarded to Mr Soriot in 2013 under the AZIP to compensate him for LTI awards from previous employment forfeited on his recruitment as the Company’s CEO. Governance Committee membership The Committee members as at 31 December 2023 were Sheri McCoy (Chair of the Committee), Philip Broadley, Nazneen Rahman and Michel Demaré. Ms Rahman joined the Committee on 1 May 2023. Leif Johansson was also a member of the Committee until he retired from the Board on 27 April 2023. The Deputy Company Secretary acts as secretary to the Committee. The Committee met six times in 2023 and members’ attendance records are set out on page 77. During the year, the Committee was materially assisted, except in relation to their own remuneration, by the CEO; the CFO; the SVP, Finance, Group Controller & Head of Global Finance Services; the SVP, Group Planning & Finance Business Partnering; the SVP, Global Portfolio/Project Management and Strategic Planning; the VP, Global SHE & Operations Sustainability; the Chief Human Resources Officer, Chief Compliance Officer and General Counsel; the SVP, Reward, Inclusion and Talent Acquisition; the Senior Director Executive Reward; the Company Secretary; the Deputy Company Secretary; and the Non-Executive Directors forming the Science and Sustainability Committees. The Committee’s independent adviser attended all Committee meetings. Independent adviser to the Committee The Committee reappointed Willis Towers Watson (WTW) as its independent adviser. WTW were first appointed in September 2018, following a tender process undertaken in 2018. The tender process involved submission of written proposals, followed by shortlisted candidates being interviewed by both Committee members and members of the Company’s management. WTW’s service to the Committee during 2023 was provided on a time spent basis at a cost to the Company of £252,322, excluding VAT. During 2023, WTW also provided pensions advice and administration, and advice and support to management including market data to assist in the annual employee pay review and global pay survey data. WTW have no other connection with the Company or individual Directors. The Committee reviewed the potential for conflicts of interest related to WTW and judged that there were no conflicts. WTW is a member of the Remuneration Consultants Group, which is responsible for the stewardship and development of the voluntary code of conduct in relation to executive remuneration consulting in the UK. The principles on which the code is based are transparency, integrity, objectivity, competence, due care and confidentiality. WTW adheres to the code. Directors’ Remuneration Report / Annual Report on Remuneration AstraZeneca Annual Report & Form 20-F Information 2023 125 Strategic Report Corporate Governance Financial Statements Additional Information |
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Governance continued Malus and clawback The Committee regularly reviews the Company’s approach to malus and clawback and market practice in this area, and our Global Standard on Malus and Clawback sets out the trigger events and the time periods these provisions may apply to. As a condition of annual bonus and Performance Share Plan awards, the Committee seeks active acceptance of the malus and clawback terms applicable each year before any payment or grant is made to an individual. Additionally, the Committee’s practice is to fully document and evidence any application of malus or clawback to show that it has not acted arbitrarily, capriciously or irrationally in making any determination. This allows the Committee to: > Reduce the amount of bonus or PSP payable, or clawback some or all of any award in the circumstances and periods as set out within our Global Standard on Malus and Clawback. > Cancel bonus eligibility. > Prevent vesting of the PSP and/or DBP awards by holding the shares in AstraZeneca’s LTI nominee platform to prevent transactions. Shareholder voting at the AGM At the Company’s AGM on 27 April 2023, shareholders voted in favour of a resolution to approve the Annual Statement of the Chair of the Remuneration Committee and the Annual Report on Remuneration for the year ended 31 December 2022. The Directors’ Remuneration Policy was approved by shareholders at the Company’s AGM on 11 May 2021. The Policy can be found on the Company’s website, www.astrazeneca.com/annualreport2022. Resolution Votes for % for Votes against % against Total votes cast % of issued share capital voted Withheld votes Ordinary Resolution to approve the Annual Statement of the Chair of the Remuneration Committee and the Annual Report on Remuneration for the year ended 31 December 2022 (2023 AGM) 1,195,261,107 94.23 73,125,360 5.77 1,268,386,467 81.84 850,827 Ordinary Resolution to approve the Directors’ Remuneration Policy (2021 AGM) 564,935,789 60.19 373,708,277 39.81 938,644,066 71.50 21,415,088 The response to the shareholder vote to approve the Directors’ Remuneration Policy at the 2021 AGM is outlined in the 2021 Directors’ Remuneration Report in our 2021 Annual Report. Directors’ service contracts and letters of appointment The notice periods and unexpired terms of Executive Directors’ service contracts at 31 December 2023 are shown in the table below. Executive Director Effective date of service contract Unexpired term at 31 December 2023 Notice period Pascal Soriot 15 December 2016 12 months 12 months Aradhana Sarin 1 August 2021 12 months 12 months None of the Non-Executive Directors has a service contract but each has a letter of appointment. In accordance with the Company’s Articles, following their appointment, all Directors must retire at each AGM and may present themselves for re-election. The Chair of the Board may terminate his appointment at any time, on three months’ notice. None of the other Non-Executive Directors has a notice period or any provision in their letters of appointment giving them a right to compensation upon early termination of appointment. Basis of preparation of this Directors’ Remuneration Report This Directors’ Remuneration Report has been prepared in accordance with the Large and Medium-sized Companies and Groups (Accounts and Reports) (Amendment) Regulations 2013 (as amended) (the 2013 Regulations). A resolution to receive and approve the Directors’ Remuneration Report will be proposed at the AGM on 11 April 2024. On behalf of the Board A C N Kemp Company Secretary 8 February 2024 126 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Annual Report on Remuneration continued |
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Changes to Remuneration Policy and its implementation The table below summarises the main proposed changes to the Directors’ Remuneration Policy (the Policy), the intended changes to implementation of the Policy in 2024 and the rationale for each change. The full Policy that shareholders will be asked to approve is set out from page 128. 2024 Policy Summary Element Proposed change to Policy Implementation in 2024 Rationale for change Base pay No change. Increase for CEO or CFO in line with the workforce. Pension No change. Pension allowance of 11% of base pay, aligned with the wider UK workforce. Annual bonus Increase maximum opportunity from 250% to 300% of base pay. Any shares awarded under the Deferred Bonus Plan (DBP) will now ordinarily be retained in the event of a resignation of an Executive Director and vest at the end of the relevant deferral period, with the Committee retaining its discretion to lapse awards on resignation should it deem it necessary to do so. CEO bonus: > Target: 150% of base pay (2023: 125%) > Max: 300% of base pay (2023: 250%) CFO bonus: > Target: 100% of base pay (No change) > Max: 200% of base pay (No change) Increased maximum opportunity to bring AstraZeneca in line with relevant market pay levels, reflecting the size, scope and ambition of the Company, enabling market competitive opportunities underpinned by exceptional performance. Simplifies the operation of the DBP and aligns Executive Directors with the treatment of deferred shares for the other members of the Senior Executive Team (SET). The Committee currently has discretion to allow awards to be retained by an Executive Director following their resignation, but the default treatment under the previous Policy is for any awards to lapse. Performance Share Plan (PSP) Increase maximum opportunity from 650% to 850% of base pay. Increase CEO PSP award from 650% to 850% of base pay. Increase CFO PSP award from 450% to 550% of base pay. Recognition of CEO’s and CFO’s criticality to future business success and delivery of our 2030 Bold Ambition. Continuing to close the gap to market pay levels and address the pay compression issue within the competitive global and European pharmaceutical talent pool. Increased weighting on long-term performance and further shareholder alignment with a greater emphasis on variable pay, reflecting the size, scope and ambition of the Company, enabling market competitive opportunities underpinned by exceptional performance. Shareholding requirements Increase shareholding requirements to mirror the maximum value of their variable pay opportunity (annual bonus and long-term incentives): > Shareholding requirement for CEO increases from 650% to 1,150% of base pay > Shareholding requirement for CFO increases from 450% to 750% of base pay Executive Directors will have a period of five years to build a shareholding to meet this requirement. For two years following cessation of employment, Executive Directors are required to hold shares to the value of their shareholding requirement that applied at the cessation of their employment; or, in cases where the individual has not had sufficient time to build up shares to meet their guideline, the actual level of shareholding at cessation. Ensures further alignment with shareholders during and post-employment. Directors’ Remuneration Report / Remuneration Policy AstraZeneca Annual Report & Form 20-F Information 2023 127 Strategic Report Corporate Governance Financial Statements Additional Information Directors’ Remuneration Policy |
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Remuneration Policy This section sets out the Policy proposed for approval by shareholders at the Company’s AGM on 11 April 2024. Subject to shareholder approval, the Policy is intended to remain in effect for three years from the 2024 AGM. The previous page summarises how the new Policy differs from the Policy which was approved by shareholders at the 2021 AGM. Setting the Policy The Remuneration Committee (the Committee) is responsible for setting overall remuneration policy and makes decisions about specific remuneration arrangements in the broader context of employee remuneration throughout the Group. The Committee reviews remuneration data for the wider workforce at several points during the year, including ratios of average employee pay to senior executive pay; bonus and base pay data; as well as gender and geographical data in relation to base pay and variable compensation. This includes a workforce remuneration review to understand the ways in which reward is differentiated by contribution across the population. Remuneration for all roles within the organisation is benchmarked against that for comparable roles in similar organisations and in the employee’s local market. Executive Directors’ remuneration is benchmarked against global and European pharmaceutical peer groups. In reviewing the base pay of Executive Directors, the Committee considers the overall level of any base pay increases being awarded to employees in the Executive Director’s local market in the relevant year. In setting, reviewing and implementing the Policy, the Committee seeks independent advice and ensures that no Director makes decisions relating to their own remuneration. The Committee connects with the Audit Committee to ensure that the Group’s remuneration policies and practices achieve the right balance between appropriate incentives to reward good performance, management of risk, and the pursuit of the Company’s strategic objectives. The Board as a whole takes responsibility for gathering the views of AstraZeneca’s workforce, and does so through multiple channels of engagement. While the Committee does not consult employees specifically when setting the Policy, the Company engages with employees, either on a Group-wide basis or in the context of smaller focus groups, to solicit feedback generally on a wide range of matters, including pay. Details of our approach to executive remuneration and its implementation are available to employees on our intranet site, Nucleus. Many employees are also shareholders in the Company and therefore have the opportunity to vote on the Policy at the 2024 AGM. In all aspects of its work, the Committee considers both the external environment in which the Company operates and the guidance issued by organisations representing institutional shareholders. It consults the Company’s major investors on general and specific remuneration matters and provides opportunities for representatives of those investors to meet the Chair of the Committee and other Committee and Board members. It is the Company’s policy to seek input from major shareholders on an ad hoc basis when significant changes to remuneration arrangements are proposed. A thorough consultation process was undertaken as this Policy was developed, with investors’ feedback on the Committee’s proposals influencing the final Policy. The Company’s shareholders are encouraged to attend the AGM and any views expressed will be considered by Committee members. Legacy arrangements The Committee may approve remuneration payments and payments for loss of office on terms that differ to the terms in the Policy where the terms of the payment were agreed before the Policy came into effect or were agreed at a time when the relevant individual was not a Director of the Company (provided that, in the opinion of the Committee, the agreement was not entered into in consideration for the individual becoming a Director of the Company). This includes the exercise of any discretion available to the Committee in connection with such payments. For these purposes, payments include the Committee satisfying awards of variable remuneration, including share awards, in line with the terms agreed at the time the award was granted. Minor amendments The Committee may make minor amendments to the arrangements for Directors described in the Policy without shareholder approval for regulatory, exchange control, tax or administrative purposes or to take account of a change in legislation. 128 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Remuneration Policy continued |
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Fixed elements of remuneration: base pay, benefits and pension Base pay Purpose and link to strategy Operation Maximum opportunity Intended to be sufficient to attract, retain and develop high-calibre individuals When setting base pay, the Committee gives consideration to a number of factors, including (but not limited to): > recognition of the value of an individual’s personal performance and contribution > the individual’s skills and experience > internal relativities > conditions in the relevant external market Base pay is normally reviewed annually with any change usually taking effect from 1 January. While there is no formal maximum, any increase in base pay will normally be in line with the percentage increase awarded to the employee population within the individual’s country location. A higher increase may be made if the Committee considers it appropriate, for example to reflect: > an increase in the scope and/or responsibility of the individual’s role; or > development of the individual within the role. Benefits Purpose and link to strategy Operation Maximum opportunity Intended to provide a market-competitive benefits package sufficient to attract, retain and develop high-calibre individuals UK Executive Directors may be provided with a fund, the value of which is based on a range of benefits, including private medical provision for themselves, partner and children; life assurance; company car; additional holidays; and other additional benefits made available by the Company from time to time that the Committee considers appropriate based on the Executive Director’s circumstances. A Director may choose to take a proportion or the entirety of the fund as cash. Non UK-based Executive Directors will receive a range of benefits (or a fund of equivalent value) comparable to those typically offered in their local market. Depending on local market practices, they may be able to elect to take the fund as cash or elect to take one or more of these benefits and take the balance as cash. At its discretion, the Committee may consider support towards reasonable costs associated with relocation and/or provide an allowance towards reasonable fees for professional services such as legal, tax, property and financial advice. The Company may also fund the cost of a driver and car for Executive Directors and any expenses deemed to be taxable which are reasonably incurred in the course of the Company’s business, together with any taxes thereon. The Company provides directors’ and officers’ liability insurance and an indemnity to the fullest extent permitted by law and the Company’s Articles. The maximum value of the benefits available will be equivalent to the cost to the Company of the suite of benefits available in the local market at the time. The value of the support towards the costs of relocation, professional fees and other costs will be the reasonable costs associated with the Executive Director’s particular circumstances. The maximum value of the directors’ and officers’ liability insurance and third-party indemnity insurance is the cost at the relevant time. While the Committee has not set an overall level of benefit provision, the Committee keeps the benefit policy and benefit levels under review. Pension Purpose and link to strategy Operation Maximum opportunity Provision of retirement benefits to attract, retain and develop high-calibre individuals UK-based Executive Directors receive a pension allowance based on a percentage of base pay, which the Director may elect to pay into a pension scheme (or an equivalent arrangement) or take as cash. Non UK-based Executive Directors will receive an allowance for the purpose of providing retirement benefits in line with local market practice. A non UK-based Executive Director may be offered the opportunity to elect to take some or all of the allowance as cash. The maximum pension allowance that may be provided to UK-based Executive Directors shall be capped at a level in line with the pension arrangements of other UK employees. The maximum value that may be provided to non UK-based Executive Directors will be aligned with employees in the relevant local market. Directors’ Remuneration Report / Remuneration Policy AstraZeneca Annual Report & Form 20-F Information 2023 129 Strategic Report Corporate Governance Financial Statements Additional Information |
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Variable elements of remuneration: annual bonus and Long-term incentive (LTI) Annual bonus and Deferred Bonus Plan (DBP) Purpose and link to strategy Operation Maximum opportunity The annual bonus incentivises and rewards short-term performance against Group targets and individual objectives that are closely aligned to the Company’s strategy The deferred share element of the annual bonus is designed to align Executive Directors’ interests with those of shareholders Annual bonus awards are conditional on performance. Performance is measured over one year and the bonus, if awarded, is paid after the year end. Normally, half of the bonus is delivered in cash and half is delivered in shares, which are deferred for three years under the DBP. DBP awards may consist of Ordinary Shares or American Depositary Shares (ADSs) depending on the country in which the Director is based. In line with the approach for other employees, a Director may be offered the opportunity to elect to defer part of their cash bonus into pension. Stretching Group targets are set annually by the Committee based on the key strategic priorities for the year. The performance targets form a Group scorecard, which is closely aligned to the Company’s strategy, and are currently designed to reward scientific, commercial and financial delivery. Performance is assessed in relation to each performance target on a standalone basis. A threshold level of performance is specified; if performance falls below this level, there will be no payout for that proportion of the award. Payout levels are determined by the Committee after the year end, based on performance against the Group scorecard targets as well as each Executive Director’s individual performance. The Committee may use its discretion to ensure that a fair and balanced outcome is achieved, taking into account the overall performance of the Company and the experience of shareholders. On vesting of the deferred shares, additional shares (or cash) equivalent in value to the dividends that would have been paid during the deferral period will be awarded to the Director. These additional shares (or cash) may be calculated on a cumulative dividend reinvestment basis or otherwise. Malus and clawback provisions apply to the annual bonus and shares awarded under the DBP, as set out within the AstraZeneca Global Standard on Malus and Clawback. The triggers whereby the Committee has the discretion to apply malus and/or clawback include: a) serious misconduct; b) material misstatement or restatement of the audited results of the Group; or c) AstraZeneca suffering: i) significant reputational damage; ii) a material adverse effect on its financial position; or iii) a material adverse effect on its business opportunities and prospects for sustained performance or profitability. The maximum annual bonus amount that can be awarded is equivalent to 300% of base pay. 130 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Remuneration Policy continued |
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Long-term incentive (LTI): Performance Share Plan (PSP) Purpose and link to strategy Operation Maximum opportunity The PSP is designed to align the variable pay of Executive Directors with the successful execution of the Company’s strategy over the longer term PSP awards are conditional awards and may be granted over Ordinary Shares or ADSs depending on the country in which the Director is based. Vesting is dependent on the achievement of stretching performance targets and continued employment, as further described in the Treatment of LTI and Deferred Bonus Plan awards on cessation of employment section on page 136. Stretching performance targets are set by the Committee at the beginning of the relevant performance period. Performance measures are closely aligned to the Company’s strategy and are currently designed to reward scientific, ESG, commercial and financial success. The Committee will consult with major shareholders in advance if it proposes any material changes to the PSP performance measures. When selecting the performance measures for each award, the Committee weights the performance measures as it considers appropriate, taking into account strategic priorities. The Committee’s intention is to exercise appropriate judgement both when setting performance targets and assessing formulaic outcomes, in particular so that the experience of shareholders over time is taken into account. Performance is normally assessed over a three-year period commencing on 1 January in the year of grant. Shares are subject to a two-year holding period following the performance period, so vesting takes place on the fifth anniversary of grant. During the holding period, no further performance measures apply. Typically, 20% of the proportion of a PSP award linked to a performance measure will vest on achievement of the threshold level of performance and 100% will vest if the maximum level of performance is achieved in full. For relative measures (such as relative total shareholder return (TSR)) the threshold performance will be performance at or above median, and maximum performance will usually be set as achievement of performance at the upper quartile level of the peer group. Where a performance measure permits, there will be further vesting points between threshold and maximum vesting levels. The Committee may (acting fairly and reasonably) adjust or waive a performance target if an event occurs that causes it to believe that the performance target is no longer appropriate. Additional shares (or cash) equivalent in value to the dividends that would have been paid on the vesting shares during the performance and holding periods will be awarded to the Director. These additional shares (or cash award) may be calculated on a cumulative dividend reinvestment basis or otherwise. Malus and clawback provisions apply to all PSP awards, as set out within the AstraZeneca Global Standard on Malus and Clawback. The triggers whereby the Committee has the discretion to apply malus and/or clawback include: a) serious misconduct; b) material misstatement or restatement of the audited results of the Group; or c) AstraZeneca suffering: i) significant reputational damage; ii) a material adverse effect on its financial position; or iii) a material adverse effect on its business opportunities and prospects for sustained performance or profitability. The maximum market value of shares that may be awarded under the PSP in respect of any year is equivalent to 850% of the participant’s annual base pay at the date of grant. Directors’ Remuneration Report / Remuneration Policy AstraZeneca Annual Report & Form 20-F Information 2023 131 Strategic Report Corporate Governance Financial Statements Additional Information |
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UK Employee Share Plans Share Incentive Plan (SIP) Purpose and link to strategy Operation Maximum opportunity Encouraging employee share ownership The Company operates an HM Revenue & Customs (HMRC)- approved SIP whereby UK employees, including Executive Directors, may elect to save a regular amount to be used to purchase shares. The Company currently grants one matching share in respect of every four shares purchased by the participant. Participants may contribute up to £150 per month from pre-tax pay or such other maximum amount as determined by the Company within the parameters of applicable legislation. Save As You Earn Share Option Scheme (SAYE) Purpose and link to strategy Operation Maximum opportunity Encouraging employee share ownership The Company operates an HMRC-approved SAYE whereby UK employees, including Executive Directors, may save a regular amount over three or five years and are granted options to purchase shares at the end of the saving period. A maximum discount of 20% to the market price prevailing at the date of the commencement of the scheme applies to the option price. Participants may save up to £500 per month from post-tax pay or such other maximum amount as determined by the Company within the parameters of applicable legislation. The maximum opportunity available to participants in a non UK-based all-employee share scheme will be determined by the Company within the parameters of applicable legislation. Differences in remuneration policy for other employees The Company’s approach to determining and reviewing the base pay of the Executive Directors and the employee population as a whole is the same. On an annual basis, the base pay for individual roles are reviewed in the context of the external market. AstraZeneca participates in annual global compensation surveys, which provide benchmarking data for all roles within the organisation, ensuring a robust base pay review process for all roles. The Company seeks to provide an appropriate range of competitive benefits, including healthcare and pension, to all employees (including Executive Directors) in the context of their local market. Employees globally may be eligible for LTI awards in the form of the PSP and/or restricted stock units depending on their level and market. The occupants of senior roles in the Company are currently eligible for PSP awards – these are the leaders who have the ability to directly influence the execution of the Company’s strategic goals. A proportion of each Senior Executive Team (SET) member’s annual bonus is deferred into shares under the DBP. An LTI award may be used for the same purpose as described above on the recruitment of employees, or for employees other than Directors, for retention. 132 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Remuneration Policy continued |
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Remuneration scenarios for Executive Directors The charts below illustrate how much the current Executive Directors could receive under different performance scenarios in 2024. Dividend equivalents payable in respect of PSP awards are not included in the scenarios. To compile the charts, the following assumptions have been made: Minimum remuneration > Base pay is that applicable in 2024. > Taxable benefits are those included in the Executive Directors’ realised pay table for 2023, as set out in the table on page 106. > Pension value is 11% of base pay. Base pay £’000 Taxable benefits £’000 Pension £’000 Total £’000 Pascal Soriot (CEO) 1,486 140 163 1,789 Aradhana Sarin (CFO) 951 46 105 1,102 Remuneration for performance in line with the Company’s expectations > Annual bonus payout is equivalent to 150% of 2024 base pay for Pascal Soriot and 100% of 2024 base pay for Aradhana Sarin. > PSP share award vesting at 425% of 2024 base pay for Pascal Soriot and 275% of 2024 base pay for Aradhana Sarin (representing 50% of the face value of the PSP award). Maximum remuneration > Annual bonus payout equivalent to 300% of 2024 base pay for Pascal Soriot and 200% of 2024 base pay for Aradhana Sarin. > PSP share award vesting at 850% of 2024 base pay for Pascal Soriot and 550% of 2024 base pay for Aradhana Sarin (representing 100% of the face value of the PSP award). Share price appreciation > The potential impact of share price appreciation on PSP award values in the maximum remuneration scenario is illustrated, assuming a 50% increase on the share price at grant. Minimum In line Maximum 100 17 22 61 9 24 67 Share price appreciation 7 18 50 25 Fixed remuneration Annual bonus Long-term incentive Share price appreciation £1,789m £10,331m £18,874m £25,188m Pascal Soriot (%) Minimum In line Maximum 100 24 20 56 13 23 64 Share price appreciation 10 18 48 24 Fixed remuneration Annual bonus Long-term incentive Share price appreciation £1,102m £4,670m £8,238m £10,855m Aradhana Sarin (%) Approach to recruitment remuneration for Executive Directors On the recruitment of a new Executive Director, the Committee seeks to pay no more than is necessary to attract and retain the best candidate available, within the limits of our approved Policy. The Committee will offer a remuneration package that it considers appropriate in the particular circumstances of the recruitment, giving due regard to the interests of the Company’s shareholders and taking into account factors such as typical market practice, existing arrangements for the other Executive Directors, internal relativities and market positioning. The pharmaceutical industry is global, and future Executive Directors might be recruited from organisations with pay structures and practices that differ from AstraZeneca’s usual Policy. The Committee believes that it is in the interests of shareholders for it to retain an element of flexibility in its approach to recruitment to enable it to attract the best candidates; however, this flexibility is limited. The Committee may find it necessary to compensate a new recruit for forfeiture of entitlements as a consequence of the recruit leaving their previous employment to join AstraZeneca. There is no limit to the value of such compensation arrangements, however the Committee will rigorously consider the appropriate value so as not to pay more than the compensation being forfeited. The Committee will seek to offer a package weighted towards equity in the Company, and will usually seek to use the PSP as the primary vehicle for buy-out awards where possible; however, the precise nature of the compensation arrangement will depend on the type of entitlement being forfeited. The arrangement might therefore comprise a combination of cash, share awards granted under the PSP (subject to the Policy maximum), and other restricted shares. The Committee may introduce a one-off arrangement as permitted under Listing Rule 9.4.2 in order to deliver a restricted share award. Malus and clawback provisions would normally apply to buy-out awards, for the same reasons as detailed under the DBP and PSP. Restricted share awards will only be granted as part of the recruitment arrangements to compensate for loss of remuneration opportunities suffered on leaving previous employment. The Committee considers whether the lost incentives were subject to performance targets and their probability of vesting. The normal approach is to seek broadly to mirror the timing of vesting and application of performance targets of the compensation being forfeited. For example, a buy-out award may be granted without performance conditions where the foregone compensation was not subject to performance testing, however the Committee may apply appropriate performance measures if it considers it appropriate. The Committee may allow a restricted share award to vest in tranches at different dates. If no performance targets are attached to a compensatory award, it will vest in full if the individual remains in employment on the vesting date. On vesting, additional shares (or cash) equivalent in value to the dividends that would have been paid during the vesting period will be awarded to the Director. These additional shares (or cash) may be calculated on a cumulative dividend reinvestment basis or otherwise. Directors’ Remuneration Report / Remuneration Policy AstraZeneca Annual Report & Form 20-F Information 2023 133 Strategic Report Corporate Governance Financial Statements Additional Information |
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All other aspects of a new recruit’s compensation opportunity will be subject to the maximum variable pay stated in the Policy table. In the case of Group employees who are promoted internally to the position of Executive Director, the Committee expects to honour all remuneration arrangements entered into before the promotion. The Company may reimburse the costs of financial planning, legal and tax advice and reasonable costs incurred on recruitment, including relocation support. Service contracts for Executive Directors Save as noted below, it is not intended that service contracts for new Executive Directors will contain terms that are materially different from those summarised below or contained in the Policy. The contractual obligations below are applicable to each of the current Executive Directors unless stated otherwise. Copies of the Executive Directors’ service contracts can be inspected at the Company’s Registered Office. Notice period The service contracts of Executive Directors do not have a fixed term but the Company may terminate employment by giving not less than 12 months’ written notice. The Company may agree on appointment that any notice given by the Company will not expire prior to the second anniversary of the commencement date of the Executive Director’s appointment. Executive Directors may terminate their employment on 12 months’ written notice. Payments in lieu of notice The Company may terminate an Executive Director’s contract at any time with immediate effect and pay a sum in lieu of notice. This sum will consist of (i) the base pay that they would have been entitled to receive during the notice period and, (ii) the cost to the Company of funding the benefit arrangements for this period, including the Company’s contribution in respect of pension. Garden leave The Company has the right to place the Executive Director on ‘garden leave’. Summary termination The Company may terminate employment summarily in particular defined circumstances, such as gross misconduct, with no further payment. Payments in lieu of holiday If, on termination, the Executive Director has exceeded their accrued holiday entitlement, the value of this excess may be deducted by the Company from any sums payable. If the Executive Director has unused holiday entitlement, the Committee has discretion to require the Executive Director to take such unused holiday during any notice period or make a payment in lieu of it calculated in the same way as the value of any excess holiday. Directors’ and officers’ liability insurance Directors’ and officers’ liability insurance and an indemnity, to the fullest extent permitted by law and the Company’s Articles, is provided for the duration of an Executive Director’s employment and for a minimum of five years following termination. Principles of payment for loss of office for Executive Directors The Company does not make additional payments for loss of office, other than, as appropriate, payments in lieu of notice as described above, or payments in respect of damages if the Company terminates an Executive Director’s service contract in breach of contract (taking into account, as appropriate, the Director’s responsibility to mitigate any losses). The Committee has discretion to award payments in certain circumstances, as set out on the following page, depending on the nature of the termination and the Executive Director’s performance. The LTI plans are governed by plan rules, which define how individual awards under those plans should be treated upon termination of employment and corporate activity, including sale of a business outside the Group. The treatment of awards in these circumstances will be determined according to the rules and subject to Committee discretion. Aside from the reasons relating to corporate activity, generally, awards under LTI plans will be allowed to vest for those Executive Directors who leave the Company in circumstances such as ill health, injury, disability, redundancy or retirement, or any other reason the Committee considers appropriate, or where employment terminates by reason of the Executive Director’s death (see the table on page 136 for further information). Awards that are allowed to vest will typically be pro-rated for time, subject to the Committee’s discretion. In addition to any payment in lieu of notice, the individual components of remuneration and other payments which may be payable on loss of office are set out on the following pages, subject to the terms of any applicable bonus rules or share plan rules. No awards will vest where an individual has been dismissed for cause. 134 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Remuneration Policy continued |
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Annual bonus At the discretion of the Committee, an Executive Director may receive a bonus for the performance year in which they leave the Company. Typically, this sum will reflect a bonus pro-rated for the part of the year in which they worked. This will depend on the circumstances, including an assessment of performance against the scorecard and the Executive Director’s performance in the relevant period and the circumstances of their departure, and may be in such proportion of cash and/or shares as the Committee will determine. The deferred share element of previous bonuses granted, and any deferred share element of the bonus awarded in respect of the departing year, may still vest for the benefit of the departing Executive Director at the end of the period of deferral. The Committee has the discretion to accelerate and/or retain the deferral period and allow shares to vest for the benefit of the Executive Director on their departure and/or in accordance with the vesting schedule as the case may be. LTI plans The LTI plan rules envisage circumstances under which some, all or none of the shares held under LTI plans will vest in connection with departure. The exact timing and number of shares vesting will depend on the circumstances, including the reason for leaving (as set out in the table on the next page) and may be subject to Committee discretion, depending on what it considers to be fair and reasonable in the circumstances. Restricted share awards The treatment on termination will depend upon the terms of the individual Executive Director’s awards on recruitment. The Committee has discretion to determine the treatment at the time of departure based on what it considers to be fair and reasonable in the circumstances. Non-statutory redundancy payments Executive Directors are not entitled to non-statutory redundancy payments. Pension allowance and other benefits Pension allowance and other benefits for Executive Directors will be payable up to the termination date and/or as part of a payment in lieu of notice as described on page 134. Payments in relation to statutory rights The amount considered reasonable to pay by the Committee in respect of statutory rights may be included in the overall termination payment. Payments required by law The Committee reserves the right to make any other payments in connection with an Executive Director’s cessation of office or employment where the payments are made in good faith in discharge of an existing legal obligation (or by way of damages for breach of such an obligation), or by way of settlement of any claim arising in connection with the cessation of an Executive Director’s office or employment. Mitigation The departing Executive Director will be required to mitigate their loss by using reasonable efforts to secure new employment. Professional fees The Company may pay an amount considered reasonable by the Committee in respect of fees for legal and tax advice, and outplacement support for the departing Executive Director. Directors’ Remuneration Report / Remuneration Policy AstraZeneca Annual Report & Form 20-F Information 2023 135 Strategic Report Corporate Governance Financial Statements Additional Information |
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Treatment of LTI and Deferred Bonus Plan awards on cessation of employment Plan Termination by mutual agreement (broadly in circumstances of ill-health, injury, disability, redundancy or retirement and in the case of death and certain corporate events, e.g. sale of a business outside the Group) Other leaver scenarios Deferred Bonus Plan (Annual bonus) Awards will vest at the end of the relevant deferral period, unless the Committee decides otherwise. In the case of dismissal for gross misconduct, the awards will lapse. In other circumstances, the shares will be retained in full and vest at the end of the deferral period, unless the Committee decides otherwise. PSP Where cessation of employment occurs within three years of the date of grant, awards will vest, pro rata, to the time elapsed between the date of grant of the award and the date of cessation of employment, after the end of the performance period, to the extent that the performance target(s) measured over the performance period has been met. However, the Committee has discretion to permit the award to vest immediately on cessation of employment to the extent that the performance target(s) has, in the opinion of the Committee, been satisfied from the date of grant to the date of cessation of employment. However, if the Committee believes that exceptional circumstances warrant this, it may exercise its discretion to vest the award on another basis. Where cessation of employment occurs during any holding period, the award will vest in respect of all the shares that continue to be subject to the award as soon as practicable following the cessation of employment. However, the Committee has discretion to require the award to vest only at the end of the holding period. Where cessation of employment occurs within three years of the date of grant, ordinarily awards will lapse unless the Committee exercises its discretion to preserve all or part of an award and apply the default treatment for leavers by mutual agreement as described in this table. This discretion will not be exercised in the case of dismissal for gross misconduct. Where cessation of employment occurs during any holding period, the award will vest in respect of all the shares that continue to be subject to the award as soon as practicable following the cessation of employment. However, the Committee has discretion to require the award to vest only at the end of the holding period. This discretion will not be exercised in the case of dismissal for gross misconduct and the award will lapse on termination. Restricted shares In relation to awards granted at the time of the Executive Director’s recruitment to the Company in compensation for any awards or bonuses forfeited at their previous employer, the award will vest on the date their employment ceases. The Committee will, in its discretion, determine the proportion of shares which vests, and (unless exceptional circumstances apply) take into account the period elapsed between the date of grant and the date of cessation of employment. Ordinarily awards will lapse unless the Committee exercises its discretion to preserve all or part of an award. 136 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Remuneration Policy continued |
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Remuneration Policy for Non-Executive Directors Non-Executive Directors, including the Chair, receive annual Board fees. With the exception of the Chair, Non-Executive Directors receive additional fees for membership and for holding the position of Chair of a Board Committee or senior independent Non-Executive Director. Non-Executive Directors are not eligible for performance-related bonuses or to participate in any of the Company’s share-based incentive plans. No pension contributions are made on their behalf. The annual Board fees applicable to Non-Executive Directors are set out in the Annual Report on Remuneration. Changes to these fees in future years will be set out in the corresponding year’s Annual Report on Remuneration. The remuneration of Non-Executive Directors (excluding the Chair) is determined by the Chair and the Executive Directors. The remuneration of the Chair is determined by the other members of the Committee and the senior independent Non-Executive Director. Annual Board fees Purpose and link to strategy Operation Maximum opportunity Intended to attract, retain and develop high-calibre individuals Board fees for Non-Executive Directors are subject to periodic review and may be increased in the future to ensure that they remain sufficient to attract high-calibre individuals while remaining fair and proportionate. Although Non-Executive Directors currently receive their fees in cash, the Company may pay part or all of their fees in the form of shares. Non-Executive Directors are eligible to receive a base fee and additional fees where appropriate to reflect any additional time commitment or duties (e.g. being the Chair of a Committee). The fee structure is set out in the Annual Report on Remuneration. The aggregate ordinary remuneration of the Non-Executive Directors shall not exceed the maximum specified in Articles 88 and 89 of the Company’s Articles, as approved by the Company’s shareholders. As at the date of this Policy, the maximum aggregate remuneration is £3,000,000 per annum and any Non-Executive Director who serves on any Board Committee may be paid such extra remuneration as the Board may determine. Benefits Purpose and link to strategy Operation Maximum opportunity Intended to attract and retain high-calibre individuals The Company provides directors’ and officers’ liability insurance and an indemnity to the fullest extent permitted by law and the Company’s Articles and may also reimburse the costs of financial planning and tax advice. The maximum amount payable in respect of these costs and the cost of insurance will be the reimbursement of the Non-Executive Directors’ benefits grossed up for any tax payable by the individual. Other costs and expenses Purpose and link to strategy Operation Maximum opportunity Intended to reimburse individuals for legitimately incurred costs and expenses The Committee has the discretion to reimburse contributions by the Company to office costs of the Chair and other Non-Executive Directors in circumstances where such payments are deemed proportionate and reasonable. The Company will pay for all travel (including travel to the Company’s offices), hotel and other expenses reasonably incurred by Non-Executive Directors (and any associated tax thereon) in the course of the Company’s business, e.g., professional fees such as secretarial support, and reimbursement for domestic security arrangements such as lights and alarms following a security assessment. There are no contractual provisions for clawback or malus of other costs and expenses. The maximum amounts payable in respect of these costs and expenses will be the reimbursement of the Non-Executive Directors’ costs and expenses grossed up for any tax payable by the individual. Directors’ Remuneration Report / Remuneration Policy AstraZeneca Annual Report & Form 20-F Information 2023 137 Strategic Report Corporate Governance Financial Statements Additional Information |
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Letters of appointment None of the Non-Executive Directors has a service contract but each has a letter of appointment. The terms and conditions of appointment of Non-Executive Directors may be viewed on the Governance page of the AstraZeneca website, at www.astrazeneca.com. In accordance with the Company’s Articles, following their appointment, all Directors must retire at each AGM and may present themselves for re-election. The Company is mindful of the director independence provisions of the 2018 UK Corporate Governance Code and, in this regard, a Non-Executive Director’s overall tenure will not normally exceed nine years. The Chair may terminate his appointment at any time, on three months’ notice. None of the other Non-Executive Directors has a notice period or any provision in their letter of appointment giving them a right to compensation upon early termination of appointment. On behalf of the Board A C N Kemp Company Secretary 8 February 2024 138 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Remuneration Policy continued |
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Contents Preparation of the Financial Statements and Directors’ Responsibilities 140 Directors’ Annual Report on Internal Controls over Financial Reporting 140 Auditors’ Report 141 Consolidated Statements 148 Group Accounting Policies 152 Notes to the Group Financial Statements 160 Group Subsidiaries and Holdings 211 Company Statements 216 Company Accounting Policies 218 Notes to the Company Financial Statements 220 Group Financial Record 223 Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 139 Strategic Report Corporate Governance Financial Statements Additional Information |
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140 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements The Directors are responsible for preparing this Annual Report and Form 20-F Information and the Group and Parent Company Financial Statements in accordance with applicable law and regulations. Company law requires the Directors to prepare Financial Statements for each financial year. Under that law the Directors have prepared the Group Financial Statements in accordance with UK-adopted international accounting standards and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards and Parent Company Financial Statements in accordance with United Kingdom Generally Accepted Accounting Practice (United Kingdom Accounting Standards, comprising FRS 101 ‘Reduced Disclosure Framework’, and applicable law). In preparing the Group Financial Statements, the Directors have also elected to comply with IFRS Accounting Standards as issued by the International Accounting Standards Board (IASB) and International Accounting Standards as adopted by the European Union. Under company law, the Directors must not approve the Financial Statements unless they are satisfied that they give a true and fair view of the state of affairs of the Group and Parent Company and of their profit or loss for that period. In preparing each of the Group and Parent Company Financial Statements, the Directors are required to: > select suitable accounting policies and then apply them consistently > make judgements and estimates that are reasonable and prudent > for the Group Financial Statements, state whether they have been prepared in accordance with UK-adopted International Accounting Standards > for the Parent Company Financial Statements, state whether FRS 101 has been followed, subject to any material departures disclosed and explained in the Parent Company Financial Statements > prepare the Financial Statements on the going concern basis unless it is inappropriate to presume that the Group and the Parent Company will continue in business. The Directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Parent Company’s transactions and disclose with reasonable accuracy at any time the financial position of the Parent Company and enable them to ensure that its Financial Statements comply with the Companies Act 2006. They have general responsibility for taking such steps as are reasonably open to them to safeguard the assets of the Group and to prevent and detect fraud and other irregularities. Under applicable law and regulations, the Directors are also responsible for preparing a Directors’ Report, Strategic Report, Directors’ Remuneration Report, Corporate Governance Report and Audit Committee Report that comply with that law and those regulations. The Directors are responsible for the maintenance and integrity of the corporate and financial information included on our website. Legislation in the UK governing the preparation and dissemination of Financial Statements may differ from legislation in other jurisdictions. Directors’ responsibility statement pursuant to DTR 4 The Directors confirm that to the best of our knowledge: > the Financial Statements, prepared in accordance with the applicable set of accounting standards, give a true and fair view of the assets, liabilities, financial position and profit or loss of the Company and the undertakings included in the consolidation taken as a whole > the Directors’ Report includes a fair review of the development and performance of the business and the position of the issuer and the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties that they face. On behalf of the Board of Directors on 8 February 2024 Pascal Soriot Director The Directors are responsible for establishing and maintaining adequate internal control over financial reporting. AstraZeneca’s internal control over financial reporting is designed to provide reasonable assurance over the reliability of financial reporting and the preparation of consolidated financial statements in accordance with generally accepted accounting principles. Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. The Directors assessed the effectiveness of AstraZeneca’s internal control over financial reporting as at 31 December 2023 based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013). Based on this assessment, internal control over financial reporting is effective. PricewaterhouseCoopers LLP, an independent registered public accounting firm, has audited the effectiveness of internal control over financial reporting as at 31 December 2023 and has issued an unqualified report thereon. Directors’ Annual Report on Internal Controls over Financial Reporting Preparation of the Financial Statements and Directors’ Responsibilities |
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AstraZeneca Annual Report & Form 20-F Information 2023 141 Strategic Report Corporate Governance Financial Statements Additional Information Report on the audit of the financial statements Opinion In our opinion: > AstraZeneca PLC’s Group financial statements and Company financial statements (the “financial statements”) give a true and fair view of the state of the Group’s and of the Company’s affairs as at 31 December 2023 and of the Group’s profit and the Group’s cash flows for the year then ended; > the Group financial statements have been properly prepared in accordance with UK-adopted international accounting standards as applied in accordance with the provisions of the Companies Act 2006; > the Company financial statements have been properly prepared in accordance with United Kingdom Generally Accepted Accounting Practice (United Kingdom Accounting Standards, including FRS 101 “Reduced Disclosure Framework”, and applicable law); and > the financial statements have been prepared in accordance with the requirements of the Companies Act 2006. We have audited the financial statements, included within the Annual Report and Form 20-F Information 2023 (the “Annual Report”), which comprise: the Consolidated Statement of Financial Position and the Company Balance Sheet as at 31 December 2023; the Consolidated Statement of Comprehensive Income, the Consolidated Statement of Cash Flows, the Consolidated and Company Statements of Changes in Equity for the year then ended; the Group and Company Accounting Policies; and the Notes to the Group and Company Financial Statements. Our opinion is consistent with our reporting to the Audit Committee. Separate opinion in relation to International Accounting Standards as adopted by the European Union As explained in the Group Accounting Policies to the financial statements, the Group, in addition to applying UK-adopted international accounting standards, has also applied International Accounting Standards as adopted by the European Union. In our opinion, the Group financial statements have been properly prepared in accordance with International Accounting Standards as adopted by the European Union. Separate opinion in relation to IFRS Accounting Standards as issued by the IASB As explained in the Group Accounting Policies to the financial statements, the Group, in addition to applying UK-adopted international accounting standards, has also applied IFRS Accounting Standards as issued by the International Accounting Standards Board (IASB). In our opinion, the Group financial statements have been properly prepared in accordance with IFRS Accounting Standards as issued by the IASB. Basis for opinion We conducted our audit in accordance with International Standards on Auditing (UK) (“ISAs (UK)”) and applicable law. Our responsibilities under ISAs (UK) are further described in the Auditors’ responsibilities for the audit of the financial statements section of our report. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion. Independence We remained independent of the Group in accordance with the ethical requirements that are relevant to our audit of the financial statements in the UK, which includes the FRC’s Ethical Standard, as applicable to listed public interest entities, and we have fulfilled our other ethical responsibilities in accordance with these requirements. To the best of our knowledge and belief, we declare that non-audit services prohibited by the FRC’s Ethical Standard were not provided. Other than those disclosed in Note 31, we have provided no non-audit services to the Company or its controlled undertakings in the period under audit. Our audit approach Overview Audit scope > We identified eight reporting components which required a full scope audit of their complete financial information, either due to their size or risk characteristics. These components are the principal operating units in the US (two components), the UK, Sweden, China (two components) and Ireland, as well as the Company. One or more individual balances for certain of these reporting components were audited by our team based in Poland (for research and development and inventory) and our team in Malaysia (property, plant and equipment), as these are the locations where the accounting records reside. > We also included Japan and Germany as two additional reporting components which had one or more individual balances that were considered significant to the Group’s financial statements. For these components our work was solely focussed on revenue, accounts receivable and journals testing. > We also identified five shared service centres where audit procedures were performed over certain shared service functions for IT general controls and transaction processing. Audit procedures were performed centrally in relation to various balances and activities accounted for and managed centrally including: goodwill, intangible assets (excluding software), pension obligations, centralised cash, borrowings and financial instruments, taxation, other investments and litigation matters, as well as the consolidation. > The above procedures accounted for 72% of the Group’s revenue and 72% of the Group’s absolute profit before tax. Key audit matters > Recognition and measurement of accruals for Managed Care, Medicaid and Medicare Part D rebates on US Product Sales (excluding Rare Diseases) (Group) > Impairment assessment of the product, marketing and distribution rights and other intangibles (Group) > Recognition and measurement of legal provisions and disclosure of contingent liabilities (Group) > Recognition, measurement and disclosure of tax liabilities for uncertain tax treatments (Group) > Valuation of defined benefit obligations in the UK and Sweden (Group) > Distributable reserves in the Company (Parent) Materiality > Overall Group materiality: $440m (2022: $400m) based on approximately 5% of profit before tax after adding back intangible asset impairment charges (Note 10), fair value movements and discount unwind on contingent consideration and other payables assumed from the Alexion acquisition (Note 20), the discount unwind on the Acerta Pharma share purchase liability (Note 3), the discount unwind on certain other payables arising from intangible asset acquisitions (Note 3), material legal net settlements (Note 21), the unwind of the fair value adjustment to Alexion inventories (Note 2) and restructuring charges relating to the Post Alexion Acquisition Group Review (Note 2). > Overall Company materiality: $110m (2022: $100m) based on 0.2% of net assets as constrained by the allocation of overall Group materiality. > Performance materiality: $330m (2022: $300m) (Group) and $82.5m (2022: $75m) (Company). The scope of our audit As part of designing our audit, we determined materiality and assessed the risks of material misstatement in the financial statements. Key audit matters Key audit matters are those matters that, in the auditors’ professional judgement, were of most significance in the audit of the financial statements of the current period and include the most significant assessed risks of material misstatement (whether or not due to fraud) identified by the auditors, including those which had the greatest effect on: the overall audit strategy; the allocation of resources in the audit; and directing the efforts of the engagement team. These matters, and any comments we make on the results of our procedures thereon, were addressed in the context of our audit of the financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters. This is not a complete list of all risks identified by our audit. The key audit matters below are consistent with last year. Financial Statements / Independent auditors’ report to the members of AstraZeneca PLC Independent auditors’ report to the members of AstraZeneca PLC |
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142 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements Key audit matter How our audit addressed the key audit matter Recognition and measurement of accruals for Managed Care, Medicaid and Medicare Part D rebates on US Product Sales (excluding Rare Diseases) (Group) Refer to the Audit Committee Report, Group Accounting Policies and Notes 1 and 20 in the Group financial statements. In the US the Group recognises revenue on Product Sales under various commercial and government mandated contracts and reimbursement arrangements that include rebates, of which the most significant are Managed Care, Medicaid and Medicare Part D relating to US Product Sales. Rebates provided to customers under these arrangements are accounted for as variable consideration, and recognised as a reduction to revenue, for which unsettled amounts are accrued. At the time Product Sales are invoiced, rebates and deductions that the Group expects to pay, are estimated. There is significant management estimation in determining the accruals in the US. Assumptions used to estimate the rebates are monitored and adjusted regularly in light of contractual and legal obligations, historical trends, past experience and projected market conditions. The US Rebates, chargebacks, returns and other revenue accruals liability (excluding Rare Diseases) at 31 December 2023 amounted to $4,926m (2022: $3,822m), principally consisting of rebates related to Managed Care, Medicaid and Medicare Part D. We evaluated the design and tested the operating effectiveness of controls relating to the recognition and measurement of the accruals for the Managed Care, Medicaid and Medicare Part D. We determined that we could rely on these controls for the purposes of our audit. We: > developed an independent estimate of the Managed Care, Medicaid and Medicare Part D accruals using the terms of the specific rebate programmes and/or contracts with customers, historical revenue data; market demand and market conditions in the US; third party information on inventory held by direct and indirect customers; and the historical trend of actual rebate claims paid; > compared our independent estimates to the accruals recorded by management; > assessed the effect of any adjustments to prior years’ accruals in the current year’s results; and > tested actual payments made and rebate claims processed by the Group, and evaluated those claims for consistency with the contractual and mandated terms of the Group’s arrangements. We utilised our in-house experts with specialised skills and knowledge to assist in assessing the compliance of the Group’s Medicaid rebate policies against the regulatory policies, and subsequently evaluating the Group’s calculation of the Medicaid drug rebate. Based on the procedures performed, we considered the accruals to be reasonable. We evaluated the disclosures in Notes 1 and 20 of the Group financial statements, and considered them to be appropriate. Impairment assessment of the product, marketing and distribution rights and other intangibles (Group) Refer to the Audit Committee Report, Group Accounting Policies and Note 10 in the Group financial statements. The Group has product, marketing and distribution rights and other intangible assets (hereafter referred to as the intangible assets) totalling $37,587m at 31 December 2023 (2022: $38,890m). Those intangible assets under development and not available for use are tested annually for impairment and other intangible assets are tested when there is an indication of impairment loss or reversal. The recoverability of the carrying value of cash generating units (to which the intangible assets belong) depends on future cash flows and/or the outcome of research and development (‘R&D’) activities including decisions by the Group to terminate development. The determination of the recoverable amounts include significant estimates, which are highly sensitive and depend upon key assumptions including the outcome of R&D activities, probability of technical and regulatory success, market volume, share and pricing (to derive peak year sales), the amount and timing of projected future cash flows and sales erosion curves following patent expiry. Changes in these assumptions could have an impact on the recoverable amount of the Group’s intangible assets. During 2023, $434m (2022: $241m) of net impairment charges were recorded (of which $417m (2022: $95m) was recorded in Research and development expenses and $17m (2022: $146m) within Selling, general and administrative costs). We evaluated the design and tested the operating effectiveness of controls over management’s assessment of the impairment of intangible assets. We determined that we could rely on these controls for the purposes of our audit. For those assets or cash generating units in the scope of our audit we: > tested management’s process for assessing whether there is an indication of impairment and the process for determining the recoverable amount; > tested the completeness and accuracy of the models as well as the underlying data used in the models, which included reconciling the cash flows to the Board approved Group level budgets and forecasts; and > evaluated the significant assumptions used by management in determining future cash flows, including the probability of technical and regulatory success, peak year sales and sales erosion curves. In evaluating the reasonableness of management’s assumptions we: > compared significant assumptions to external data and benchmarks; and > performed a retrospective comparison of forecasted revenues and costs to actual performance. We utilised our in-house valuation experts to assist with the evaluation of the probability of technical and regulatory success. Based on the procedures performed, we determined that the net impairment charge recorded for intangible assets was reasonable. We evaluated the disclosures in Note 10 of the Group financial statements, and considered them to be appropriate. Recognition and measurement of legal provisions and disclosure of contingent liabilities (Group) Refer to the Audit Committee Report, Group Accounting Policies, Notes 21 and 30 in the Group financial statements. The Group is involved in various legal proceedings, including actual or threatened litigation and actual or potential government investigations relating to employment matters, product liability, commercial disputes, pricing, sales and marketing practices, infringement of IP rights and the validity of certain patents and competition laws. As at 31 December 2023 the Group held provisions of $1,016m (2022: $161m) in respect of legal claims and settlements (together, legal provisions) and disclosed the more significant legal proceedings as contingent liabilities in Note 30. There is significant judgement by management when assessing the timing and likelihood of loss being incurred and whether a legal provision can be reasonably estimated and recorded or if a contingent liability needs to be disclosed. Management’s assessment of the amounts concerned relies heavily on estimates and assumptions. We evaluated the design and tested the operating effectiveness of controls in respect of the recognition and measurement of legal proceedings and related disclosures. We determined that we could rely on these controls for the purposes of our audit. We enquired of internal legal counsel and where appropriate external legal counsel. We obtained and evaluated letters of audit enquiry with the Group’s internal and external legal counsel for significant litigation. We have inspected certain external legal documents. We tested the completeness of management’s assessment of both the identification of legal proceedings and possible outcomes of each significant legal claim. We evaluated the reasonableness of management’s assessment regarding whether an adverse outcome is probable and estimated reliably. We evaluated management’s judgement regarding the proceedings set out as contingent liabilities within Note 30. Based on the procedures performed, for the provisions recorded and contingent liabilities disclosed, we considered them to be reasonable. We evaluated the disclosures in Notes 21 and 30 of the Group financial statements, and considered them to be appropriate. Independent auditors’ report to the members of AstraZeneca PLC continued |
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AstraZeneca Annual Report & Form 20-F Information 2023 143 Strategic Report Corporate Governance Financial Statements Additional Information Key audit matter How our audit addressed the key audit matter Recognition, measurement and disclosure of tax liabilities for uncertain tax treatments (Group) Refer to the Audit Committee Report, Group Accounting Policies and Note 30 in the Group financial statements. The Group faces a number of audits and reviews in jurisdictions around the world and, in some cases, is in dispute with tax authorities. At 31 December 2023 the total net tax liability recognised in respect of uncertain tax treatments is $1,336m (2022: $830m). The Group estimates the potential for additional liabilities where the possibility of the additional liabilities falling due is more than remote and at 31 December 2023 this was $679m (2022: $734m). Tax liabilities recognised for uncertain tax treatments require management to make key judgements with respect to the outcome of current and potential future tax audits, reviews and disputes with tax authorities, and actual results could vary from these estimates. We evaluated the design and tested the operating effectiveness of controls in respect of the recognition and measurement of uncertain tax treatments. We determined that we could rely on these controls for the purposes of our audit. We tested the completeness of management’s assessment of the identification of tax liabilities and evaluated management’s process for estimating the possible outcomes of each tax liability. We obtained the status and results of tax audits and discussions with the relevant tax authorities. With the assistance of our local and international tax specialists, we: > evaluated management’s assessment of the technical merits of tax treatments (including where relevant evaluating any advice received from the Group’s external advisors) and estimates of the amount of tax benefit expected to be sustained; > tested the completeness and accuracy of the information used in the determination of the probability of different outcomes for uncertain tax treatments and the estimation of the liability for those tax treatments; and > evaluated the reasonableness of significant assumptions related to the outcome of tax audits and assumptions relating to the most likely amount or expected value depending on the resolution of the uncertainty. Based on the procedures performed, we considered the tax liabilities to be reasonable. We evaluated the disclosures in Note 30 of the Group financial statements, and considered them to be appropriate. Valuation of defined benefit obligations in the UK and Sweden (Group) Refer to the Audit Committee Report, Group Accounting Policies and Note 22 in the Group financial statements. The Group has defined benefit obligations of $7,907m at 31 December 2023 (2022: $8,108m), which is significant in the context of the overall balance sheet. The Group’s most significant schemes are in the UK and Sweden, which comprise 86% of the Group’s defined benefit obligations. The valuation of pension plan obligations requires significant estimation in determining appropriate assumptions such as mortality (for the UK scheme only), discount rates and inflation levels (for both the UK and Sweden schemes). Movements in these assumptions can have a material impact on the determination of the defined benefit obligations. Management uses external actuaries to assist in determining the assumptions. We evaluated the design and tested the operating effectiveness of controls in respect of the assumptions used and accuracy of the Group’s most significant defined benefit obligations. We determined that we could rely on these controls for the purposes of our audit. We used actuarial experts to assess whether the assumptions used in calculating the defined benefit obligations for the UK and Sweden were reasonable. Our actuarial experts assisted in developing an independent expectation of the defined benefit obligations for the UK and Sweden. Our experts evaluated whether the mortality assumptions (UK scheme only) and the discount rates and inflation rates (for both the UK and Sweden schemes) were: > consistent with the specifics of each plan and where relevant considering national information; > consistent with independently developed estimates; and > in line with other companies’ recent external reporting. We evaluated the calculations prepared by management’s external actuaries which included testing the completeness and accuracy of the underlying data. In order to evaluate the reasonableness of management’s estimate, our experts also compared the independent estimate to management’s estimate. Based on the procedures performed, we considered management’s key assumptions to be within reasonable ranges. We evaluated the disclosures in Note 22 of the Group financial statements, and considered them to be appropriate. Financial Statements / Independent auditors’ report to the members of AstraZeneca PLC |
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144 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements Key audit matter How our audit addressed the key audit matter Distributable reserves in the Company (Parent) Refer to the Company Statement of Changes in Equity in the Company financial statements. The directors review and disclose the level of distributable reserves of the Company annually and aim to maintain distributable reserves that provide adequate cover for dividend payments. At 31 December 2023, the overwhelming majority of the Profit and loss account reserve of $17,640m (31 December 2022: all of $7,458m) was available for distribution, subject to filing the Company financial statements with Companies House. There is judgement when determining the profits available for distribution by reference to guidance on realised and distributable profits in accordance with Companies Act 2006 issued by the Institute of Chartered Accountants in England and Wales and the Institute of Chartered Accountants of Scotland in April 2017. We obtained and audited the analysis of distributable reserves. We used our distributable reserves experts to assess whether judgements made were appropriate and the analysis was aligned with the relevant technical guidance on the determination of realised profits under the Companies Act 2006. We assessed whether there is qualifying consideration in determining whether the Profit and loss account reserve is distributable. Based on our procedures, we noted no exceptions and considered the directors’ judgement in determining the profits available for distribution, and the related disclosures, to be appropriate. Independent auditors’ report to the members of AstraZeneca PLC continued |
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AstraZeneca Annual Report & Form 20-F Information 2023 145 Strategic Report Corporate Governance Financial Statements Additional Information How we tailored the audit scope We tailored the scope of our audit to ensure that we performed enough work to be able to give an opinion on the financial statements as a whole, taking into account the structure of the Group and the Company, the accounting processes and controls, and the industry in which they operate. The Group operates in over 100 countries and the size of operations within each territory varies. In establishing the overall approach to the Group audit, we determined the type of work that needed to be performed by us, as the Group engagement team, or component auditors within PwC UK and other PwC network firms operating under our instruction. Where the work was performed by component auditors, we determined the level of involvement we needed to have in the audit work in these territories to be able to conclude whether sufficient appropriate audit evidence had been obtained as a basis for our opinion on the Group financial statements as a whole. We identified eight reporting components which required a full scope audit of their complete financial information, either due to their financial significance to the Group or specific risk characteristics. These components are the principal operating units in the US (two components), China (two components), the UK, Sweden, and Ireland, as well as the Company. We also identified a further two reporting components which both had individual financial statement line item balances that were considered significant to the Group’s financial statements. For these components our work was solely focussed on the audit of revenue and accounts receivable. The two components also performed journal testing in support of an overall Group significant risk. Within our overall Group scope we performed procedures at five of AstraZeneca’s Shared Service Centres (SSCs); Warsaw, Kuala Lumpur, Delhi, Cluj and San Jose. The testing procedures performed at the SSCs included controls testing and IT general controls testing. In addition to the work performed by the SSCs a number of centralised audit procedures were Financial statements – Group Financial statements – Company Overall materiality $440m (2022: $400m). $110m (2022: $100m). How we determined it Approximately 5% of profit before tax after adding back intangible asset impairment charges (Note 10), fair value movements and discount unwind on contingent consideration and other payables assumed from the Alexion acquisition (Note 20), the discount unwind on the Acerta Pharma share purchase liability (Note 3), the discount unwind on certain other payables arising from intangible asset acquisitions (Note 3), material legal net settlements (Note 21), the unwind of the fair value adjustment to Alexion inventories (Note 2) and restructuring charges relating to the Post Alexion Acquisition Group Review (Note 2) 0.2% of net assets as constrained by the allocation of overall Group materiality Rationale for benchmark applied The reported profit of the Group can fluctuate due to intangible asset impairment charges, fair value and discount unwind movements on contingent consideration, the discount unwind on the Acerta Pharma share purchase liability, the discount unwind on certain other payables arising from intangible asset acquisitions, material legal net settlements, the unwind of the fair value adjustment to Alexion inventories and the restructuring costs resulting from the Post Alexion Acquisition Group Review. These amounts are prone to year on year volatility and are not necessarily reflective of the operating performance of the Group and as such they have been excluded from the benchmark amount. Our approach and relevant adjustments are consistent with the prior year. We have considered the nature of the business of AstraZeneca PLC (being a holding Company for investment activities) and have determined that net assets are an appropriate basis for the calculation of the overall materiality level. performed by the Group audit team. These procedures primarily related to the audit of goodwill, intangible assets (excluding software), pension obligations, centralised cash, borrowings and financial instruments, taxation, other investments, litigation matters, and the Group consolidation. Our Group engagement team’s involvement in the oversight of the reporting components and SSCs was continuous throughout the audit process. As part of our cycle of in person oversight we visited; China and the US (covering both components in each country), Sweden and Ireland and were in regular contact with our UK component team in Cambridge. We also visited the SSCs in Poland and India. In addition to these on site visits, regular virtual meetings with the component auditors were held, whereby we performed reviews of the component auditors’ planned response to significant risks, and reviewed the component auditors working papers. The work that is performed at the SSCs is overseen by the Group engagement team, and follows the same review and oversight process as the components. Alongside our team oversight we attended meetings with local management. The impact of climate risk on our audit In planning and executing our audit, we considered the potential impact of climate change on the Group’s business and the financial statements. The Group has set out its intention — as part of the Ambition Zero Carbon programme – to achieve net zero greenhouse gas emissions by maximising energy efficiency, shifting to renewable energy sources and investing in nature-based removals to compensate for any residual GHG footprint. As a part of our audit we made enquiries of management to understand the extent of the potential impact of the physical and transitional climate change risk on the Group financial statements. We also discussed the climate change initiatives and commitments from Ambition Zero Carbon and other initiatives to reduce CO2 emissions, and the impact these have on the Group including on future cash flow forecasts. This includes the committed investment to the ‘AZ Forest’ through 2030 and the continued commitment to develop next-generation respiratory inhalers with near-zero global warming potential propellants for the pMDI inhaled medicines portfolio. Management considers that the impact of climate change does not give rise to a material financial statement impact. With the assistance of our climate change experts we evaluated management’s risk assessment and understood the Group’s governance processes including the Sustainability Committee. We performed an audit risk assessment of how the impact of the Group’s commitments in respect of climate change including Ambition Zero Carbon may affect the financial statements and our audit. We challenged the extent to which climate change considerations including the expected cash flows from the initiatives and commitments had been reflected, where appropriate, in management’s impairment assessment process, going concern assessment and viability assessment. We found that climate change impacts are included within management’s forecasts although the initiatives and commitments did not have a material impact including on our key audit matters. We assessed the consistency of other information disclosed in the Annual Report with the Group financial statements, and with our knowledge obtained from the audit. Materiality The scope of our audit was influenced by our application of materiality. We set certain quantitative thresholds for materiality. These, together with qualitative considerations, helped us to determine the scope of our audit and the nature, timing and extent of our audit procedures on the individual financial statement line items and disclosures and in evaluating the effect of misstatements, both individually and in aggregate on the financial statements as a whole. Based on our professional judgement, we determined materiality for the financial statements as a whole as follows: Financial Statements / Independent auditors’ report to the members of AstraZeneca PLC |
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146 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements For each component in the scope of our Group audit, we allocated a materiality that is less than our overall Group materiality. The range of materiality allocated across components was between $45m and $250m. We use performance materiality to reduce to an appropriately low level the probability that the aggregate of uncorrected and undetected misstatements exceeds overall materiality. Specifically, we use performance materiality in determining the scope of our audit and the nature and extent of our testing of account balances, classes of transactions and disclosures, for example in determining sample sizes. Our performance materiality was 75% (2022: 75%%) of overall materiality, amounting to $330m (2022: $300m) for the Group financial statements and $82.5m (2022: $75m) for the Company financial statements. In determining the performance materiality, we considered a number of factors – the history of misstatements, risk assessment and aggregation risk and the effectiveness of controls – and concluded that an amount at the upper end of our normal range was appropriate. We agreed with the Audit Committee that we would report to them misstatements identified during our audit above $22m (Group audit) (2022: $20m) and $22m (Company audit) (2022: $20m) as well as misstatements below those amounts that, in our view, warranted reporting for qualitative reasons. Conclusions relating to going concern Our evaluation of the directors’ assessment of the Group’s and the Company’s ability to continue to adopt the going concern basis of accounting included: > agreeing the underlying cash flow projections to Board approved Group level budgets and forecasts, assessing how these forecasts are compiled, and assessing the accuracy of management’s forecasts; > evaluating the key assumptions within management’s forecasts and ensuring that such assumptions are consistent with those modelled in relation to impairments; > considering liquidity and available financial resources; > assessing whether the stress testing performed by management appropriately considered the principal risks facing the business; and > evaluating the feasibility of management’s mitigating actions in the stress testing scenarios and performing our own sensitivities. Based on the work we have performed, we have not identified any material uncertainties relating to events or conditions that, individually or collectively, may cast significant doubt on the Group’s and the Company’s ability to continue as a going concern for a period of at least twelve months from when the financial statements are authorised for issue. In auditing the financial statements, we have concluded that the directors’ use of the going concern basis of accounting in the preparation of the financial statements is appropriate. However, because not all future events or conditions can be predicted, this conclusion is not a guarantee as to the Group’s and the Company’s ability to continue as a going concern. In relation to the directors’ reporting on how they have applied the UK Corporate Governance Code, we have nothing material to add or draw attention to in relation to the directors’ statement in the financial statements about whether the directors considered it appropriate to adopt the going concern basis of accounting. Our responsibilities and the responsibilities of the directors with respect to going concern are described in the relevant sections of this report. Reporting on other information The other information comprises all of the information in the Annual Report other than the financial statements and our auditors’ report thereon. The directors are responsible for the other information. Our opinion on the financial statements does not cover the other information and, accordingly, we do not express an audit opinion or, except to the extent otherwise explicitly stated in this report, any form of assurance thereon. In connection with our audit of the financial statements, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the audit, or otherwise appears to be materially misstated. If we identify an apparent material inconsistency or material misstatement, we are required to perform procedures to conclude whether there is a material misstatement of the financial statements or a material misstatement of the other information. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report based on these responsibilities. With respect to the Strategic Report and Directors’ Report, we also considered whether the disclosures required by the UK Companies Act 2006 have been included. Based on our work undertaken in the course of the audit, the Companies Act 2006 requires us also to report certain opinions and matters as described below. Strategic Report and Directors’ Report In our opinion, based on the work undertaken in the course of the audit, the information given in the Strategic Report and Directors’ Report for the year ended 31 December 2023 is consistent with the financial statements and has been prepared in accordance with applicable legal requirements. In light of the knowledge and understanding of the Group and Company and their environment obtained in the course of the audit, we did not identify any material misstatements in the Strategic Report and Directors’ Report. Directors’ Remuneration In our opinion, the part of the Directors’ Remuneration Report to be audited has been properly prepared in accordance with the Companies Act 2006. Corporate governance statement The Listing Rules require us to review the directors’ statements in relation to going concern, longer-term viability and that part of the corporate governance statement relating to the Company’s compliance with the provisions of the UK Corporate Governance Code specified for our review. Our additional responsibilities with respect to the corporate governance statement as other information are described in the Reporting on other information section of this report. Based on the work undertaken as part of our audit, we have concluded that each of the following elements of the corporate governance statement, included within the Corporate Governance Overview, Corporate Governance Report, Nomination and Governance Committee Report, Science Committee Report, Sustainability Committee Report and Audit Committee Report is materially consistent with the financial statements and our knowledge obtained during the audit, and we have nothing material to add or draw attention to in relation to: > The directors’ confirmation that they have carried out a robust assessment of the emerging and principal risks; > The disclosures in the Annual Report that describe those principal risks, what procedures are in place to identify emerging risks and an explanation of how these are being managed or mitigated; > The directors’ statement in the financial statements about whether they considered it appropriate to adopt the going concern basis of accounting in preparing them, and their identification of any material uncertainties to the Group’s and Company’s ability to continue to do so over a period of at least twelve months from the date of approval of the financial statements; > The directors’ explanation as to their assessment of the Group’s and Company’s prospects, the period this assessment covers and why the period is appropriate; and > The directors’ statement as to whether they have a reasonable expectation that the Company will be able to continue in operation and meet its liabilities as they fall due over the period of its assessment, including any related disclosures drawing attention to any necessary qualifications or assumptions. Our review of the directors’ statement regarding the longer-term viability of the Group and Company was substantially less in scope than an audit and only consisted of making inquiries and considering the directors’ process supporting their statement; checking that the statement is in alignment with the relevant provisions of the UK Corporate Governance Code; and considering whether the statement is consistent with the financial statements and our knowledge and understanding of the Group and Company and their environment obtained in the course of the audit. In addition, based on the work undertaken as part of our audit, we have concluded that each of the following elements of the corporate governance statement is materially consistent with the financial statements and our knowledge obtained during the audit: > The directors’ statement that they consider the Annual Report, taken as a whole, is fair, balanced and understandable, and provides the information necessary for the members to assess the Group’s and Company’s position, performance, business model and strategy; > The section of the Annual Report that describes the review of effectiveness of risk management and internal control systems; and > The section of the Annual Report describing the work of the Audit Committee. We have nothing to report in respect of our responsibility to report when the directors’ statement relating to the Company’s compliance with the Code does not properly disclose a departure from a relevant provision of the Code specified under the Listing Rules for review by the auditors. Independent auditors’ report to the members of AstraZeneca PLC continued |
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AstraZeneca Annual Report & Form 20-F Information 2023 147 Strategic Report Corporate Governance Financial Statements Additional Information Responsibilities for the financial statements and the audit Responsibilities of the directors for the financial statements As explained more fully in the Preparation of the Financial Statements and Directors’ Responsibilities section, the directors are responsible for the preparation of the financial statements in accordance with the applicable framework and for being satisfied that they give a true and fair view. The directors are also responsible for such internal control as they determine is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error. In preparing the financial statements, the directors are responsible for assessing the Group’s and the Company’s ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the Group or the Company or to cease operations, or have no realistic alternative but to do so. Auditors’ responsibilities for the audit of the financial statements Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditors’ report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements. Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with our responsibilities, outlined above, to detect material misstatements in respect of irregularities, including fraud. The extent to which our procedures are capable of detecting irregularities, including fraud, is detailed below. Based on our understanding of the Group and industry, we identified that the principal risks of non-compliance with laws and regulations related to patent protection, product safety (including but not limited to the US Food and Drug Administration regulation, the European Medicines Agency, the UK Medicines and Healthcare products Regulatory Agency, China Food and Drug Administration), antibribery and competition law (including but not limited to the Foreign Corrupt Practices Act, the Proceeds of Crime Act and the provisions set out by the National Healthcare Security Administration in China), and we considered the extent to which non-compliance might have a material effect on the financial statements. We also considered those laws and regulations that have a direct impact on the financial statements such as the Companies Act 2006 and tax legislation. We evaluated management’s incentives and opportunities for fraudulent manipulation of the financial statements (including the risk of override of controls), and determined that the principal risks were related to journal entries to manipulate financial results and potential management bias in accounting estimates. The Group engagement team shared this risk assessment with the component auditors so that they could include appropriate audit procedures in response to such risks in their work. Audit procedures performed by the Group engagement team and/or component auditors included: > Evaluation and testing of the design and operating effectiveness of management’s controls to prevent and detect irregularities; > Discussions with VP Group Internal Audit, the Deputy Chief Compliance Officer, the Head of Global Investigations and the Group’s General Counsel and Deputy General Counsels along with other members of Group legal and external counsel where applicable, including consideration of known or suspected instances of non-compliance with laws and regulations and fraud; > Assessment of matters reported on the Group’s whistleblowing helpline and the results of management’s investigation of such matters; > Challenging assumptions made by management in its significant accounting estimates, in particular in relation to the recognition and measurement of certain rebate accruals in the US (excluding Rare Diseases), the impairment of intangible assets (excluding goodwill and software development costs), the recognition and measurement of legal provisions and disclosure of contingent liabilities, the recognition and measurement of uncertain tax treatments, and the valuation of the defined benefit obligations (see related key audit matters above); and > Identifying and testing the validity of journal entries, in particular any journal entries posted with unusual account combinations, and consolidation journals. There are inherent limitations in the audit procedures described above. We are less likely to become aware of instances of non-compliance with laws and regulations that are not closely related to events and transactions reflected in the financial statements. Also, the risk of not detecting a material misstatement due to fraud is higher than the risk of not detecting one resulting from error, as fraud may involve deliberate concealment by, for example, forgery or intentional misrepresentations, or through collusion. Our audit testing might include testing complete populations of certain transactions and balances, possibly using data auditing techniques. However, it typically involves selecting a limited number of items for testing, rather than testing complete populations. We will often seek to target particular items for testing based on their size or risk characteristics. In other cases, we will use audit sampling to enable us to draw a conclusion about the population from which the sample is selected. A further description of our responsibilities for the audit of the financial statements is located on the FRC’s website at: www.frc.org.uk/auditorsresponsibilities. This description forms part of our auditors’ report. Use of this report This report, including the opinions, has been prepared for and only for the Company’s members as a body in accordance with Chapter 3 of Part 16 of the Companies Act 2006 and for no other purpose. We do not, in giving these opinions, accept or assume responsibility for any other purpose or to any other person to whom this report is shown or into whose hands it may come save where expressly agreed by our prior consent in writing. Other required reporting Companies Act 2006 exception reporting Under the Companies Act 2006 we are required to report to you if, in our opinion: > we have not obtained all the information and explanations we require for our audit; or > adequate accounting records have not been kept by the Company, or returns adequate for our audit have not been received from branches not visited by us; or > certain disclosures of directors’ remuneration specified by law are not made; or > the Company financial statements and the part of the Directors’ Remuneration Report to be audited are not in agreement with the accounting records and returns. We have no exceptions to report arising from this responsibility. Appointment Following the recommendation of the Audit Committee, we were appointed by the members on 27 April 2017 to audit the financial statements for the year ended 31 December 2017 and subsequent financial periods. The period of total uninterrupted engagement is seven years, covering the years ended 31 December 2017 to 31 December 2023. Other matter As required by the Financial Conduct Authority Disclosure Guidance and Transparency Rule 4.1.14R, these financial statements form part of the ESEF-prepared annual financial report filed on the National Storage Mechanism of the Financial Conduct Authority in accordance with the ESEF Regulatory Technical Standard (‘ESEF RTS’). This auditors’ report provides no assurance over whether the annual financial report has been prepared using the single electronic format specified in the ESEF RTS. Sarah Quinn (Senior Statutory Auditor) for and on behalf of PricewaterhouseCoopers LLP Chartered Accountants and Statutory Auditors London 8 February 2024 Financial Statements / Independent auditors’ report to the members of AstraZeneca PLC |
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Consolidated Statement of Comprehensive Income for the year ended 31 December 2023 2022 2021 Notes $m $m $m Product Sales 1 43,789 42,998 36,541 Alliance Revenue 1 1,428 755 388 Collaboration Revenue 1 594 598 488 Total Revenue 45,811 44,351 37,417 Cost of sales (8,268) (12,391) (12,437) Gross profit 37,543 31,960 24,980 Distribution expense (539) (536) (446) Research and development expense 2 (10,935) (9,762) (9,736) Selling, general and administrative expense 2 (19,216) (18,419) (15,234) Other operating income and expense 2 1,340 514 1,492 Operating profit 8,193 3,757 1,056 Finance income 3 344 95 43 Finance expense 3 (1,626) (1,346) (1,300) Share of after tax losses in associates and joint ventures 11 (12) (5) (64) Profit/(loss) before tax 6,899 2,501 (265) Taxation 4 (938) 792 380 Profit for the period 5,961 3,293 115 Other comprehensive income: Items that will not be reclassified to profit or loss: Remeasurement of the defined benefit pension liability 22 (406) 1,118 626 Net gains/(losses) on equity investments measured at fair value through other comprehensive income 278 (88) (187) Fair value movements related to own credit risk on bonds designated as fair value through profit or loss (6) 2 – Tax on items that will not be reclassified to profit or loss 4 101 (216) 105 (33) 816 544 Items that may be reclassified subsequently to profit or loss: Foreign exchange arising on consolidation 23 608 (1,446) (483) Foreign exchange arising on designated liabilities in net investment hedges 23 24 (282) (321) Fair value movements on cash flow hedges 266 (97) (167) Fair value movements on cash flow hedges transferred to profit and loss (145) 73 208 Fair value movements on derivatives designated in net investment hedges 23 44 (8) 34 Costs of hedging (19) (7) (6) Tax on items that may be reclassified subsequently to profit or loss 4 (12) 73 46 766 (1,694) (689) Other comprehensive income/(expense) for the period, net of tax 733 (878) (145) Total comprehensive income/(expense) for the period 6,694 2,415 (30) Profit attributable to: Owners of the Parent 5,955 3,288 112 Non-controlling interests 26 6 5 3 Total comprehensive income/(expense) attributable to: Owners of the Parent 6,688 2,413 (33) Non-controlling interests 26 6 2 3 Basic earnings per $0.25 Ordinary Share 5 $3.84 $2.12 $0.08 Diluted earnings per $0.25 Ordinary Share 5 $3.81 $2.11 $0.08 Weighted average number of Ordinary Shares in issue (millions) 5 1,549 1,548 1,418 Diluted weighted average number of Ordinary Shares in issue (millions) 5 1,562 1,560 1,427 Dividends declared and paid in the period 25 4,487 4,485 3,882 All activities were in respect of continuing operations. $m means millions of US dollars. 148 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Consolidated Statement of Financial Position at 31 December 2023 2022 2021 Notes $m $m $m Assets Non-current assets Property, plant and equipment 7 9,402 8,507 9,183 Right-of-use assets 8 1,100 942 988 Goodwill 9 20,048 19,820 19,997 Intangible assets 10 38,089 39,307 42,387 Investments in associates and joint ventures 11 147 76 69 Other investments 12 1,530 1,066 1,168 Derivative financial instruments 13 228 74 102 Other receivables 14 803 835 895 Deferred tax assets 4 4,718 3,263 4,330 76,065 73,890 79,119 Current assets Inventories 15 5,424 4,699 8,983 Trade and other receivables 16 12,126 10,521 9,644 Other investments 12 122 239 69 Derivative financial instruments 13 116 87 83 Intangible assets 10 – – 105 Income tax receivable 1,426 731 663 Cash and cash equivalents 17 5,840 6,166 6,329 Assets held for sale 18 – 150 368 25,054 22,593 26,244 Total assets 101,119 96,483 105,363 Liabilities Current liabilities Interest-bearing loans and borrowings 19 (5,129) (5,314) (1,660) Lease liabilities 8 (271) (228) (233) Trade and other payables 20 (22,374) (19,040) (18,938) Derivative financial instruments 13 (156) (93) (79) Provisions 21 (1,028) (722) (768) Income tax payable (1,584) (896) (916) (30,542) (26,293) (22,594) Non-current liabilities Interest-bearing loans and borrowings 19 (22,365) (22,965) (28,134) Lease liabilities 8 (857) (725) (754) Derivative financial instruments 13 (38) (164) (45) Deferred tax liabilities 4 (2,844) (2,944) (6,206) Retirement benefit obligations 22 (1,520) (1,168) (2,454) Provisions 21 (1,127) (896) (956) Other payables 20 (2,660) (4,270) (4,933) (31,411) (33,132) (43,482) Total liabilities (61,953) (59,425) (66,076) Net assets 39,166 37,058 39,287 Equity Capital and reserves attributable to equity holders of the Company Share capital 24 388 387 387 Share premium account 35,188 35,155 35,126 Capital redemption reserve 153 153 153 Merger reserve 448 448 448 Other reserves 23 1,464 1,468 1,444 Retained earnings 23 1,502 (574) 1,710 39,143 37,037 39,268 Non-controlling interests 26 23 21 19 Total equity 39,166 37,058 39,287 The Financial Statements from pages 148 to 215 were approved by the Board and were signed on its behalf by Pascal Soriot Aradhana Sarin Director Director 8 February 2024 Consolidated Statement of Financial Position AstraZeneca Annual Report & Form 20-F Information 2023 149 Strategic Report Corporate Governance Financial Statements Additional Information |
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Consolidated Statement of Changes in Equity for the year ended 31 December Share Capital Total Non-Share premium redemption Merger Other Retained attributable controlling Total capital account reserve reserve reserves earnings to owners interests equity $m $m $m $m $m $m $m $m $m At 1 January 2021 328 7,971 153 448 1,423 5,299 15,622 16 15,638 Profit for the period – – – – – 112 112 3 115 Other comprehensive expense1 – – – – – (145) (145) – (145) Transfer to other reserves2 – – – – 21 (21) – – – Transactions with owners Dividends (Note 25) – – – – – (3,882) (3,882) – (3,882) Issue of Ordinary Shares 59 27,155 – – – – 27,214 – 27,214 Share-based payments charge for the period (Note 29) – – – – – 615 615 – 615 Settlement of share plan awards – – – – – (781) (781) – (781) Issue of replacement Alexion share awards upon acquisition (Note 27)3 – – – – – 513 513 – 513 Net movement 59 27,155 – – 21 (3,589) 23,646 3 23,649 At 31 December 2021 387 35,126 153 448 1,444 1,710 39,268 19 39,287 Profit for the period – – – – – 3,288 3,288 5 3,293 Other comprehensive expense1 – – – – – (875) (875) (3) (878) Transfer to other reserves2 – – – – 24 (24) – – – Transactions with owners Dividends (Note 25) – – – – – (4,485) (4,485) – (4,485) Issue of Ordinary Shares – 29 – – – – 29 – 29 Share-based payments charge for the period (Note 29) – – – – – 619 619 – 619 Settlement of share plan awards – – – – – (807) (807) – (807) Net movement – 29 – – 24 (2,284) (2,231) 2 (2,229) At 31 December 2022 387 35,155 153 448 1,468 (574) 37,037 21 37,058 Profit for the period – – – – – 5,955 5,955 6 5,961 Other comprehensive income1 – – – – – 733 733 – 733 Transfer to other reserves2 – – – – (4) 4 – – – Transactions with owners Dividends (Note 25) – – – – – (4,487) (4,487) – (4,487) Dividends paid to non-controlling interests (Note 25) – – – – – – – (4) (4) Issue of Ordinary Shares 1 33 – – – – 34 – 34 Share-based payments charge for the period (Note 29) – – – – – 579 579 – 579 Settlement of share plan awards – – – – – (708) (708) – (708) Net movement 1 33 – – (4) 2,076 2,106 2 2,108 At 31 December 2023 388 35,188 153 448 1,464 1,502 39,143 23 39,166 1 Included within Other comprehensive income of $733m (2022: expense of $878m; 2021: expense of $145m) is a charge of $19m (2022: charge of $7m; 2021: charge of $6m), relating to Costs of hedging. 2 Amounts charged or credited to Other reserves relate to exchange adjustments arising on goodwill. 3 Replacement share awards were issued as part of the acquisition of Alexion in 2021 (see Note 27). 150 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Consolidated Statement of Cash Flows for the year ended 31 December 2023 2022 2021 Notes $m $m $m Cash flows from operating activities Profit/(loss) before tax 6,899 2,501 (265) Finance income and expense 3 1,282 1,251 1,257 Share of after tax losses of associates and joint ventures 11 12 5 64 Depreciation, amortisation and impairment 5,387 5,480 6,530 Increase in trade and other receivables (1,425) (1,349) (961) (Increase)/decrease in inventories (669) 3,941 1,577 Increase in trade and other payables and provisions 2,394 1,165 1,405 Gains on disposal of intangible assets 2 (251) (104) (513) Gains on disposal of investments in associates and joint ventures 2 – – (776) Fair value movements on contingent consideration arising from business combinations 20 549 82 14 Non-cash and other movements 17 (386) (692) 95 Cash generated from operations 13,792 12,280 8,427 Interest paid (1,081) (849) (721) Tax paid (2,366) (1,623) (1,743) Net cash inflow from operating activities 10,345 9,808 5,963 Cash flows from investing activities Acquisition of subsidiaries, net of cash acquired 27 (189) (48) (9,263) Payments upon vesting of employee share awards attributable to business combinations 27 (84) (215) (211) Payment of contingent consideration from business combinations 20 (826) (772) (643) Purchase of property, plant and equipment (1,361) (1,091) (1,091) Disposal of property, plant and equipment 132 282 13 Purchase of intangible assets (2,417) (1,480) (1,109) Disposal of intangible assets 291 447 587 Movement in profit-participation liability 2 190 – 20 Purchase of non-current asset investments (136) (45) (184) Disposal of non-current asset investments 32 42 9 Movement in short-term investments, fixed deposits and other investing instruments 97 (114) 96 Payments to associates and joint ventures 11 (80) (26) (92) Disposal of investments in associates and joint ventures – – 776 Interest received 287 60 34 Net cash outflow from investing activities (4,064) (2,960) (11,058) Net cash inflow/(outflow) before financing activities 6,281 6,848 (5,095) Cash flows from financing activities Proceeds from issue of share capital 33 29 29 Issue of loans and borrowings 3,816 – 12,929 Repayment of loans and borrowings (4,942) (1,271) (4,759) Dividends paid (4,481) (4,364) (3,856) Hedge contracts relating to dividend payments (19) (127) (29) Repayment of obligations under leases (268) (244) (240) Movement in short-term borrowings 161 74 (276) Payments to acquire non-controlling interests – – (149) Payment of Acerta Pharma share purchase liability (867) (920) – Net cash (outflow)/inflow from financing activities (6,567) (6,823) 3,649 Net (decrease)/increase in Cash and cash equivalents in the period (286) 25 (1,446) Cash and cash equivalents at the beginning of the period 5,983 6,038 7,546 Exchange rate effects (60) (80) (62) Cash and cash equivalents at the end of the period 17 5,637 5,983 6,038 Consolidated Statement of Cash Flows AstraZeneca Annual Report & Form 20-F Information 2023 151 Strategic Report Corporate Governance Financial Statements Additional Information |
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Group Accounting Policies Basis of accounting and preparation of financial information The Consolidated Financial Statements have been prepared under the historical cost convention, modified to include revaluation to fair value of certain financial instruments and pension plan assets and liabilities as described below, in accordance with UK-adopted international accounting standards and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards. The Consolidated Financial Statements also comply fully with IFRS Accounting Standards as issued by the International Accounting Standards Board (IASB) and International Accounting Standards as adopted by the European Union. The Consolidated Financial Statements are presented in US dollars, which is the Company’s functional currency. In preparing their individual financial statements, the accounting policies of some overseas subsidiaries do not conform with IASB-issued IFRSs. Therefore, where appropriate, adjustments are made in order to present the Consolidated Financial Statements on a consistent basis. New accounting requirements Other than noted below, amendments to accounting standards issued by the IASB and adopted in the year ended 31 December 2023 did not have a material impact on the result or financial position of the Group. IAS 12 On 23 May 2023, the IASB issued an amendment to IAS 12 ‘Income Taxes’ to clarify how the effects of the global minimum tax framework should be accounted for and disclosed effective 1 January 2023. This was endorsed by the UK Endorsement Board on 19 July 2023 and has been adopted by the Group for 2023 reporting. The Group has applied the exemption to recognising and disclosing information about deferred tax assets and liabilities related to Pillar 2 income taxes. Alliance and Collaboration Revenue Effective 1 January 2023, the Group has updated the presentation of Total Revenue on the face of the Statement of Comprehensive Income to include Alliance Revenue as a separate element to Collaboration Revenue. Alliance Revenue, previously reported within Collaboration Revenue, comprises income related to sales made by collaboration partners, where AstraZeneca is entitled to a share of gross profits, share of revenues or royalties, which are recurring in nature while the collaboration arrangement remains in place. Alliance Revenue does not include Product Sales where AstraZeneca is leading commercialisation in a territory. Collaboration Revenue arising from collaborative arrangements where the Group retains a significant ongoing economic interest and receives upfront amounts and event-triggered milestones, which arise from the licensing of intellectual property, will continue to be reported as Collaboration Revenue. In collaboration arrangements either AstraZeneca or the collaborator acts as principal in sales to the end customer. Where AstraZeneca acts as principal, AstraZeneca records 100% of sales to the end customer within Product Sales. The updated presentation reflects the increasing importance of income arising from share of gross profit arrangements where collaboration partners are responsible for booking revenues in some or all territories. The comparative revenue reported in the years to 31 December 2022 and 31 December 2021 has been retrospectively adjusted to reflect the new split of Total Revenue, resulting in Alliance Revenue being reported for the year to 31 December 2022 of $755m and to 31 December 2021 of $388m, however the combined total of Alliance Revenue and Collaboration Revenue is equal to the previously reported Collaboration Revenue total for each prior year. Basis for preparation of Financial Statements on a going concern basis The Group has considerable financial resources available. As at 31 December 2023, the Group has $12.7bn in financial resources (Cash and cash equivalent balances of $5.8bn and undrawn committed bank facilities of $6.9bn, of which $2.0bn are available until February 2025 and the remaining $4.9bn are available until April 2026, (in February 2024 these facilities were extended to April 2029), with only $5.4bn of borrowings due within one year). The Group’s revenues are largely derived from sales of medicines covered by patents, which provide a relatively high level of resilience and predictability to cash inflows, although government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues in some of our significant markets. The Group, however, anticipates new revenue streams from both recently launched medicines and those in development, and the Group has a wide diversity of customers and suppliers across different geographic areas. Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully. Accordingly, they continue to adopt the going concern basis in preparing the Annual Report and Financial Statements. Estimates and judgements The preparation of the Financial Statements in conformity with generally accepted accounting principles requires management to make estimates and judgements that affect the reported amounts of assets and liabilities at the date of the Financial Statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The accounting policy descriptions set out the areas where judgements and estimates need exercising, the most significant of which include the following Key Judgements and Significant Estimates : > revenue recognition – see Revenue Accounting Policy from page 152 and Note 1 on page 161 > expensing of internal development expenses – see Research and Development Policy from page 154 > impairment reviews of Intangible assets – see Note 10 on page 174 > useful economic life of Intangible assets – see Research and Development Policy from page 154 > business combinations and Goodwill – see Business Combinations and Goodwill Policy from page 156 and Note 27 from page 193 > litigation liabilities – see Litigation and Environmental Liabilities within Note 30 on page 204 > operating segments – see Note 6 on page 167 > employee benefits – see Note 22 on page 190 > taxation – see Note 30 from page 209 . The Group has assessed the impact of climate risk on its financial reporting. The impact assessment was primarily focused on the valuation and useful lives of intangible assets and the identification and valuation of provisions and contingent liabilities, as these are judged to be the key areas that could be impacted by climate risks. No material accounting impacts or changes to judgements or other required disclosures were noted. Key Judgements are those judgements made in applying the Group’s accounting policies that have a material effect on the amounts of assets and liabilities recognised in the Financial Statements. A Significant Estimate has a significant risk of material adjustment to the carrying amounts of assets and liabilities within the next financial year. Financial risk management policies are detailed in Note 28 to the Financial Statements from page 195. AstraZeneca’s management considers the following to be the material accounting policies in the context of the Group’s operations. Revenue Revenue comprises Product Sales, Alliance Revenue and Collaboration Revenue. Revenue excludes inter-company revenues and value-added taxes. 152 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Product Sales Product Sales represent net invoice value less estimated rebates, returns and chargebacks, which are considered to be variable consideration and include significant estimates. Sales are recognised when the control of the goods has been transferred to a third party. This is usually when title passes to the customer, either on shipment or on receipt of goods by the customer, depending on local trading terms. Revenue is not recognised in full until it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur. Rebates are amounts payable or credited to a customer, usually based on the quantity or value of Product Sales to the customer for specific products in a certain period. Product sales rebates, which relate to Product Sales that occur over a period of time, are normally issued retrospectively. At the time Product Sales are invoiced, rebates and deductions that the Group expects to pay are estimated based upon assumptions developed using contractual terms, historical experience and market-related information. The rebates and deductions are recognised as variable consideration and recorded as a reduction to revenue with an accrual recorded. These rebates typically arise from sales contracts with government payers, third-party managed care organisations, hospitals, long-term care facilities, group purchasing organisations and various state programmes. In markets where returns are significant, estimates of the quantity and value of goods which may ultimately be returned are accounted for at the point revenue is recognised. Our returns accruals are based on actual experience over the preceding 12 months for established products together with market-related information such as estimated stock levels at wholesalers and competitor activity which we receive via third-party information services. For newly launched products, we use rates based on our experience with similar products or a predetermined percentage. When a product faces generic competition, particular attention is given to the possible levels of returns and, in cases where the circumstances are such that the level of Product Sales are considered highly probable to reverse, revenues are only recognised when the right of return expires, which is generally on ultimate prescription of the product to patients. The methodology and assumptions used to estimate rebates and returns are monitored and adjusted regularly in the light of contractual and legal obligations, historical trends, past experience and projected market conditions. Once the uncertainty associated with returns is resolved, revenue is adjusted accordingly. Under certain collaboration agreements which include a profit sharing mechanism, our recognition of Product Sales depends on which party acts as principal in sales to the end customer. In the cases where AstraZeneca acts as principal, we record 100% of sales to the end customer. In the cases where AstraZeneca does not act as principal, we record the share of gross profits received within Alliance Revenue. Contracts relating to the supply of certain Vaccines & Immune Therapies medicines relating to the COVID-19 pandemic include conditions whereby payments are receivable from customers in advance of the delivery of product. Such amounts are held on the balance sheet as contract liabilities until the related revenue is recognised, generally upon product delivery. Certain of these contracts contain further provisions that restrict the use of inventory manufactured in specified supply chains to specified customers, resulting in an enforceable right to payment as the activities are performed. Under IFRS 15, such contracts require revenue to be recognised over time using an appropriate and reasonably measurable method to measure progress. Revenue is recognised on these contracts based on the proportion of product delivered compared to the total contracted volumes. Certain arrangements include bill-and-hold arrangements under which the Group invoices a customer for a product but retains physical possession of the product until it is transferred to the customer at a point in time in the future. For these types of arrangements, an assessment is made to determine when the performance obligation has been satisfied, which is when control of the product is transferred to the customer. If the customer has obtained control of the product even though that product remains in the Group’s physical possession, the performance obligation to transfer a product has been satisfied and Product Sales are recognised. Control is considered to have transferred when the reason for the bill-and-hold arrangement is substantive, the product can be identified separately as belonging to the customer, the product is ready for physical transfer to the customer and AstraZeneca is unable to use or sell the product to another customer. Alliance Revenue Alliance Revenue comprises income arising from the ongoing operation of collaborative arrangements related to sales made by collaboration partners, where AstraZeneca is entitled to a share of gross profits, share of revenues or royalties, which are recurring in nature while the collaboration agreement remains in place. Alliance Revenue does not include Product Sales where AstraZeneca is leading commercialisation in a territory, or reimbursement for AstraZeneca-incurred expenses such as R&D or promotion costs, which arise from the license of intellectual property. The Group periodically enters into transactions where it acquires part of the rights to a product intangible (either on-market or in-process R&D), but for commercial reasons does not act as principal in selling the product to the customer and therefore does not recognise income from the product in the form of Product Sales. This may occur where, for example, a collaboration partner retains the right to commercialise in a specific territory, and has sufficient local control over that commercialisation to book Product Sales, while the Group instead receives a proportion of the value generated by those Product Sales, either in the form of a royalty, a share of gross profits or a share of revenues. Where the arrangement meets the definition of a licence agreement, share of gross profits, share of revenues and sales royalties are recognised when achieved by applying the royalty exemption under IFRS 15. All other sales royalties are recognised when considered it is highly probable there will not be a significant reversal of cumulative income. The determination requires estimates to be made in relation to future Product Sales. Collaboration Revenue Collaboration Revenue includes income arising from entering into collaborative arrangements where the Group has out-licensed (sold) certain rights associated with products and where AstraZeneca retains a significant ongoing economic interest in the product. Significant interest can include ongoing supply of finished goods, profit sharing arrangements or being principal in the sales of medicines. These collaborations may include development, manufacturing and/or commercialisation arrangements with the collaborator. Income from out-licences may take the form of upfront fees and milestones. Timing of recognition of clinical and regulatory milestones is considered to be a key judgement. There can be significant uncertainty over whether it is highly probable that there would not be a significant reversal of revenue in respect of specific milestones if these are recognised before they are triggered due to them being subject to the actions of third parties. In general, where the triggering of a milestone is subject to the decisions of third parties (e.g. the acceptance or approval of a filing by a regulatory authority), the Group does not consider that the threshold for recognition is met until that decision is made. Where Collaboration Revenue arises from the licensing of the Group’s own intellectual property, the licences we grant are typically rights to use intellectual property which do not change during the period of the licence and therefore related non-conditional revenue is recognised at the point the licence is granted and variable consideration as soon as recognition criteria are met. Group Accounting Policies AstraZeneca Annual Report & Form 20-F Information 2023 153 Strategic Report Corporate Governance Financial Statements Additional Information |
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Group Accounting Policies continued Other performance obligations in the contract might include the supply of product. These arrangements typically involve the receipt of an upfront payment, which the contract attributes to the license of the intangible assets, and ongoing receipts for supply, which the contract attributes to the sale of the product we manufacture. In cases where the transaction has two or more components, we account for the delivered item (for example, the transfer of title to the intangible asset) as a separate unit of account and record revenue on delivery of that component. Where practicable, consideration is allocated to performance obligations on the basis of the standalone selling price of each performance obligation. However, where there is a licence of intellectual property, it is not always possible to establish a reliable estimate of the standalone selling price of the licence as they are unique. Therefore, in these rare situations, the residual approach is used to determine the consideration attributable to the licence. Where fixed amounts are payable over one year from the effective date of a contract, an assessment is made as to whether a significant financing component exists, and if so, the fair value of this component is deferred and recognised as financing income over the period to the expected date of receipt. Where control of a right to use licence for an intangible asset passes at the outset of an arrangement, revenue is recognised at the point in time control is transferred. Where the substance of a licence arrangement is that of a right to access rights attributable to an intangible asset, revenue, in the form of an upfront fee, is recognised over time, normally on a straight-line basis over the life of the contract. Where the Group provides ongoing development services, revenue in respect of this element is recognised over the duration of those services. Where Collaboration Revenue is recorded and there is a related intangible asset that is licensed as part of the arrangement, an appropriate amount of that intangible asset is charged to Cost of sales based on an allocation of cost or value to the rights that have been licensed. Cost of sales Cost of sales are recognised as the associated revenue is recognised. Cost of sales include manufacturing costs, royalties payable on revenues recognised, movements in provisions for inventories, inventory write-offs and impairment charges in relation to manufacturing assets. Cost of sales also includes co-collaborator sharing of profit arising from collaborations, and foreign exchange gains and losses arising from business trading activities. Research and development Research expenditure is charged to profit and loss in the year in which it is incurred. Internal development expenditure is capitalised only if it meets the recognition criteria of IAS 38 ‘Intangible Assets’. This is considered a key judgement. Where regulatory and other uncertainties are such that the criteria are not met, the expenditure is charged to profit and loss and this is almost invariably the case prior to approval of the drug by the relevant regulatory authority. Where, however, recognition criteria are met, Intangible assets are capitalised and amortised on a straight-line basis over their useful economic lives from product launch. At 31 December 2023, no amounts have met the recognition criteria. Payments to in-license products and compounds from third parties for new research and development projects (in process research and development) generally take the form of upfront payments, milestones and royalty payments. Where payments made to third parties represent consideration for future research and development activities, an evaluation is made as to the nature of the payments. Such payments are expensed if they represent compensation for sub-contracted research and development services not resulting in a transfer of intellectual property. By contrast, payments are capitalised if they represent compensation for the transfer of identifiable intellectual property developed at the risk of the third party. Such payments may be made once development or regulatory milestones are met and may also be made on the basis of sales volumes once a product is launched. Development and regulatory milestone payments are capitalised as the milestone is triggered. Sales-related payments are accrued and capitalised with reference to the latest Group sales forecasts for approved indications at the present value of expected future cash flows. Assets capitalised are amortised, on a straight-line basis, over their useful economic lives from product launch. The determination of useful economic life is considered to be a key judgement. On product launch, the Group makes a judgement as to the expected useful economic life with reference to the expiry of associated patents for the product, expectation around the competitive environment specific to the product and our detailed long-term risk-adjusted sales projections compiled annually across the Group and approved by the Board. The useful economic life can extend beyond patent expiry dependent upon the nature of the product and the complexity of the development and manufacturing process. Significant sales can often be achieved post patent expiration. Intangible assets Intangible assets are stated at cost less accumulated amortisation and impairments. Intangible assets relating to products in development are subject to impairment testing annually. All Intangible assets are tested for impairment when there are indications that the carrying value may not be recoverable. The determination of the recoverable amounts include key estimates which are highly sensitive to, and depend upon, key assumptions as detailed in Note 10 to the Financial Statements from page 172. Impairment reviews have been carried out on all Intangible assets that are in development (and not being amortised), all major intangible assets acquired during the year and all other intangible assets that have had indicators of impairment during the year. Recoverable amount is determined as the higher of value-in-use or fair value less costs to sell using a discounted cash flow calculation, with the products’ expected cash flows risk-adjusted over their estimated remaining useful economic life. Sales forecasts and specific allocated costs (which have both been subject to appropriate senior management review and approval) are risk-adjusted and discounted using appropriate rates based on our post-tax weighted average cost of capital or for fair value less costs to sell, a required rate of return for a market participant. Our weighted average cost of capital reflects factors such as our capital structure and our costs of debt and equity. Any impairment losses are recognised immediately in Operating profit. Intangible assets relating to products which fail during development (or for which development ceases for other reasons) are also tested for impairment and are written down to their recoverable amount (which is usually nil). If, subsequent to an impairment loss being recognised, development restarts or other facts and circumstances change indicating that the impairment is less or no longer exists, the value of the asset is re-estimated and its carrying value is increased to the recoverable amount, but not exceeding the original value, by recognising an impairment reversal in Operating profit. Government grants Government grants are recognised in the Consolidated Statement of Comprehensive Income so as to match with the related expenses that they are intended to compensate. Where grants are received in advance of the related expenses, they are initially recognised in the Consolidated Statement of Financial Position under Trade and other payables as deferred income and released to net off against the related expenditure when incurred. 154 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Each contract is assessed to determine whether there are both grant elements and supply of product which need to be separated. In each case, the contracts set out the specified terms for the supply of the product and the provisions for funding for certain costs, primarily research and development associated with the IP. It is considered whether there are any conditions for the funding to be refunded. The consideration in the contract is allocated between the grant and supply elements. The standalone selling price for the supply of products is determined by reference to observed prices with other customers. The amount allocated as a government grant is determined by reference to the specific agreed costs and activities identified in the contract as not directly attributable to the supply of product. Government grants are recorded as an offset to the relevant expense in the Consolidated Statement of Comprehensive Income and are capped to match the relevant costs incurred. Other operating income and expense Other operating income and expense is generated from activities outside of the Group’s normal course of business, which includes Other income from divestments of or full out-license of assets and businesses including royalties and milestones where the Group does not retain a significant continued interest. Where the arrangement meets the definition of a licence agreement, sales milestones and sales royalties are recognised when achieved by applying the royalty exemption under IFRS 15. All other milestones and sales royalties are recognised when it is considered highly probable that there will not be a significant reversal of cumulative income. The determination requires estimates to be made in relation to future Product Sales. Joint arrangements and associates The Group has arrangements over which it has joint control and which qualify as joint operations or joint ventures under IFRS 11 ‘Joint Arrangements’. For joint operations, the Group recognises its share of revenue that it earns from the joint operations and its share of expenses incurred. The Group also recognises the assets associated with the joint operations that it controls and the liabilities it incurs under the joint arrangement. For joint ventures and associates, the Group recognises its interest in the joint venture or associate as an investment and uses the equity method of accounting. Employee benefits The Group accounts for pensions and other employee benefits (principally healthcare) under IAS 19 ‘Employee Benefits’. In respect of defined benefit plans, obligations are determined using the projected unit credit method and are discounted to present value by reference to market yields on high-quality corporate bonds, while plan assets are measured at fair value. Given the extent of the assumptions used to determine the value of scheme assets and scheme liabilities, these are considered to be significant estimates. The operating and financing costs of such plans are recognised separately in profit; current service costs are spread systematically over the lives of employees and financing costs are recognised in full in the periods in which they arise. Remeasurements of the net defined benefit pension liability, including actuarial gains and losses, are recognised immediately in Other comprehensive income. Where the calculation results in a surplus to the Group, the recognised asset is limited to the present value of any available future refunds from the plan or reductions in future contributions to the plan subject to consideration of the effect any minimum funding requirement for future service has on the benefit available as a reduction in future contributions. Payments to defined contribution plans are recognised in profit as they fall due. Taxation The current tax payable is based on taxable profit for the year. Taxable profit differs from reported profit because taxable profit excludes items that are either never taxable or tax deductible or items that are taxable or tax deductible in a different period. The Group’s current tax assets and liabilities are calculated using tax rates that have been enacted or substantively enacted by the reporting date. Deferred tax is provided using the balance sheet liability method, providing for temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred tax liabilities are recognised unless they arise from the initial recognition (other than in a business combination) of assets and liabilities in a transaction that affects neither the taxable profit nor the accounting profit. Deferred tax liabilities are not recognised to the extent they arise from the initial recognition of non-tax deductible goodwill. Deferred tax assets are recognised to the extent that there are future taxable temporary differences or it is probable that future taxable profit will be available against which the asset can be utilised. This requires judgements to be made in respect of the availability of future taxable income. No deferred tax asset or liability is recognised in respect of temporary differences associated with investments in subsidiaries and branches where the Group is able to control the timing of reversal of the temporary differences and it is probable that the temporary differences will not reverse in the foreseeable future. The Group’s deferred tax assets and liabilities are calculated using tax rates that are expected to apply in the period when the liability is settled or the asset realised based on tax rates that have been enacted or substantively enacted by the reporting date. Deferred tax liabilities relating to assets recognised because of a business combination which may qualify for intellectual property incentives are measured at the relevant statutory tax rate. Deferred tax assets and liabilities are offset in the Consolidated Statement of Financial Position if, and only if, the taxable entity has a legally enforceable right to set off current tax assets and liabilities, and the Deferred tax assets and liabilities relate to taxes levied by the same taxation authority on the same taxable entity. Liabilities for uncertain tax positions require management to make judgements of potential exposures in relation to tax audit issues. Tax benefits are not recognised unless the tax positions will probably be accepted by the tax authorities. This is based upon management’s interpretation of applicable laws and regulations and the expectation of how the tax authority will resolve the matter. Once considered probable of not being accepted, management reviews each material tax benefit and reflects the effect of the uncertainty in determining the related taxable result. Liabilities for uncertain tax positions are measured using either the most likely amount or the expected value amount depending on which method the entity expects to better predict the resolution of the uncertainty. Further details of the estimates and assumptions made in determining our recorded liability for transfer pricing contingencies and other tax contingencies are included in Note 30 to the Financial Statements from page 204. Share-based payments All plans have been classified as equity settled after assessment. The grant date fair value of the market-based performance elements of employee share plan awards is calculated using a modified Monte Carlo model, with other elements at market price. In accordance with IFRS 2 ‘Share-based Payment’, the resulting cost is recognised in profit on a straight-line basis over the vesting period of the awards. The value of the charge is adjusted to reflect expected and actual levels of awards vesting, except where the failure to vest is as a result of not meeting a market condition. Cancellations of equity instruments are treated as an acceleration of the vesting period and any outstanding charge is recognised in profit immediately. Cash outflows relating to the vesting of share plans for our employees are recognised within operating activities, as they relate to employee remuneration. The cash flows relating to replacement awards issued to employees as part of the Alexion acquisition (see Note 27 from page 193) are classified within investing activities, as they are part of the aggregate cash flows arising from obtaining control of the subsidiary. Group Accounting Policies AstraZeneca Annual Report & Form 20-F Information 2023 155 Strategic Report Corporate Governance Financial Statements Additional Information |
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Group Accounting Policies continued Property, plant and equipment The Group’s policy is to depreciate the difference between the cost of each item of Property, plant and equipment and its residual value over its estimated useful life on a straight-line basis. Assets under construction are not depreciated until the asset is available for use, at which point the asset is transferred into either Land and buildings or Plant and equipment, and depreciated over its estimated useful economic life. Reviews are made annually of the estimated remaining lives and residual values of individual productive assets, taking account of commercial and technological obsolescence as well as normal wear and tear. It is impractical to calculate average asset lives exactly. However, the useful economic lives range from approximately 10 to 50 years for buildings, and three to 15 years for plant and equipment. All items of Property, plant and equipment are tested for impairment when there are indications that the carrying value may not be recoverable. Any impairment losses are recognised immediately in Operating profit. Leases The Group’s lease arrangements are principally for property, most notably a portfolio of office premises and employee accommodation, and for a global car fleet, utilised primarily by our sales and marketing teams. The lease liability and corresponding right-of-use asset arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of the following lease payments: > fixed payments, less any lease incentives receivable > variable lease payments that depend on an index or a rate, initially measured using the index or rate as at the commencement date > the exercise price of a purchase option if the Group is reasonably certain to exercise that option > payments of penalties for terminating the lease, if the lease term reflects the Group exercising that option, and > amounts expected to be payable by the Group under residual value guarantees. Right-of-use assets are measured at cost comprising the following: > the amount of the initial measurement of lease liability > any lease payments made at or before the commencement date less any lease incentives received > any initial direct costs, and > restoration costs. Judgements made in calculating the lease liability include assessing whether arrangements contain a lease and determining the lease term. Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. Property leases will often include an early termination or extension option to the lease term. Fleet management policies vary by jurisdiction and may include renewal of a lease until a measurement threshold, such as mileage, is reached. Extension and termination options have been considered when determining the lease term, along with all facts and circumstances that may create an economic incentive to exercise an extension option, or not exercise a termination option. Extension periods (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated). The lease payments are discounted using incremental borrowing rates, as in the majority of leases held by the Group the interest rate implicit in the lease is not readily identifiable. Calculating the discount rate is an estimate made in calculating the lease liability. This rate is the rate that the Group would have to pay to borrow the funds necessary to obtain an asset of similar value to the right-of-use asset in a similar economic environment with similar terms, security and conditions. To determine the incremental borrowing rate, the Group uses a risk-free interest rate adjusted for credit risk, adjusting for terms specific to the lease including term, country and currency. The Group is exposed to potential future increases in variable lease payments that are based on an index or rate, which are initially measured as at the commencement date, with any future changes in the index or rate excluded from the lease liability until they take effect. When adjustments to lease payments based on an index or rate take effect, the lease liability is reassessed and adjusted against the right-of-use asset. Lease payments are allocated between principal and finance cost. The finance cost is charged to the Consolidated Statement of Comprehensive Income over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period. Payments associated with short-term leases of Property, plant and equipment and all leases of low-value assets are recognised on a straight-line basis as an expense in the Consolidated Statement of Comprehensive Income. Short-term leases are leases with a lease term of 12 months or less. Low-value leases are those where the underlying asset value, when new, is $5,000 or less and includes IT equipment and small items of office furniture. Contracts may contain both lease and non-lease components. The Group allocates the consideration in the contract to the lease and non-lease components based on their relative standalone prices. Right-of-use assets are generally depreciated over the shorter of the asset’s useful life and the lease term on a straight-line basis. If the Group is reasonably certain to exercise a purchase option, the right-of-use asset is depreciated over the underlying asset’s useful life. It is impractical to calculate average asset lives exactly. However, the total lives range from approximately 10 to 50 years for buildings, and three to 15 years for motor vehicles and other assets. There are no material lease agreements under which the Group is a lessor. Business combinations and goodwill In assessing whether an acquired set of assets and activities is a business or an asset, management will first elect whether to apply an optional concentration test to simplify the assessment. Where the concentration test is applied, the acquisition will be treated as the acquisition of an asset if substantially all of the fair value of the gross assets acquired (excluding cash and cash equivalents, deferred tax assets, and related goodwill) is concentrated in a single asset or group of similar identifiable assets. Where the concentration test is not applied, or is not met, a further assessment of whether the acquired set of assets and activities is a business will be performed. The determination of whether an acquired set of assets and activities is a business or an asset can be judgemental, particularly if the target is not producing outputs. Management uses a number of factors to make this determination, which are primarily focused on whether the acquired set of assets and activities include substantive processes that mean the set is capable of being managed for the purpose of providing a return. Key determining factors include the stage of development of any assets acquired, the readiness and ability of the acquired set to produce outputs and the presence of key experienced employees capable of conducting activities required to develop or manufacture the assets. Typically, the specialised nature of many pharmaceutical assets and processes is such that until assets are substantively ready for production and promotion, there are not the required processes for a set of assets and activities to meet the definition of a business in IFRS 3. 156 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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On the acquisition of a business, fair values are attributed to the identifiable assets and liabilities. Attributing fair values is a key judgement; refer to Note 27 to the Financial Statements from page 193 for additional details. Contingent liabilities are also recorded at fair value unless the fair value cannot be measured reliably, in which case the value is subsumed into goodwill. Where fair values of acquired contingent liabilities cannot be measured reliably, the assumed contingent liability is not recognised but is disclosed in the same manner as other contingent liabilities. Where not all of the equity of a subsidiary is acquired, the non-controlling interest is recognised either at fair value or at the non-controlling interest’s proportionate share of the net assets of the subsidiary, on a case-by-case basis. Put options over non-controlling interests are recognised as a financial liability, with a corresponding entry in either Retained earnings or against non-controlling interest reserves on a case-by-case basis. The timing and amount of future contingent elements of consideration is an estimate. Contingent consideration, which may include development and launch milestones, revenue threshold milestones and revenue-based royalties, is fair valued at the date of acquisition using decision-tree analysis with key inputs including probability of success, consideration of potential delays and revenue projections based on the Group’s internal forecasts. Unsettled amounts of consideration are held at fair value within payables with changes in fair value recognised immediately in profit. Goodwill is the difference between the fair value of the consideration and the fair value of net assets acquired. Goodwill arising on acquisitions is capitalised and subject to an impairment review, both annually and when there is an indication that the carrying value may not be recoverable. The Group’s policy up to and including 1997 was to eliminate Goodwill arising upon acquisitions against reserves. Under IFRS 1 ‘First-time Adoption of International Financial Reporting Standards’ and IFRS 3 ‘Business Combinations’, such Goodwill will remain eliminated against reserves. Subsidiaries A subsidiary is an entity controlled, directly or indirectly, by AstraZeneca PLC. Control is regarded as the exposure or rights to the variable returns of the entity when combined with the power to affect those returns. Control is normally evidenced by holding more than 50% of the share capital of the company, however other agreements may be in place that result in control where they give AstraZeneca finance decision-making authority over the relevant activities of the company. The financial results of subsidiaries are consolidated from the date control is obtained until the date that control ceases. Inventories Inventories are stated at the lower of cost and net realisable value. The first in, first out or an average method of valuation is used. For finished goods and work in progress, cost includes directly attributable costs and certain overhead expenses (including depreciation). Selling expenses and certain other overhead expenses (principally central administration costs) are excluded. Net realisable value is determined as estimated selling price less all estimated costs of completion and costs to be incurred in selling and distribution. Write-downs of inventory occur in the general course of business and are recognised in Cost of sales for launched or approved products and in Research and development expense for products in development. Assets held for sale Non-current assets are classified as Assets held for sale when their carrying amount is to be recovered principally through a sale transaction and a sale is considered highly probable. A sale is considered highly probable only when the appropriate level of management has committed to the sale. Assets held for sale are stated at the lower of carrying amount and fair value less costs to sell. Where there is a partial transfer of a non-current asset to held for sale, an allocation of value is made between the current and non-current portions of the asset based on the relative value of the two portions, unless there is a methodology that better reflects the asset to be disposed of. Assets held for sale are neither depreciated nor amortised. Trade and other receivables Financial assets included in Trade and other receivables are recognised initially at fair value. The Group holds the Trade receivables with the objective to collect the contractual cash flows and therefore measures them subsequently at amortised cost using the effective interest method, less any impairment, based on expected credit losses. Trade receivables that are subject to debt factoring arrangements are derecognised if they meet the conditions for derecognition detailed in IFRS 9 ‘Financial Instruments’. Trade and other payables Financial liabilities included in Trade and other payables are recognised initially at fair value. Subsequent to initial recognition they are measured at amortised cost using the effective interest method. Contingent consideration payables are held at fair value within Level 3 of the fair value hierarchy as defined in Note 12. Financial instruments The Group’s financial instruments include Lease liabilities, Trade and other receivables and payables, liabilities for contingent consideration and put options under business combinations, and rights and obligations under employee benefit plans which are dealt with in specific accounting policies. The Group’s other financial instruments include: > Cash and cash equivalents > Fixed deposits > Other investments > Bank and other borrowings > Derivatives. Cash and cash equivalents Cash and cash equivalents comprise cash in hand, current balances with banks and similar institutions, and highly liquid investments with maturities of three months or less when acquired. They are readily convertible into known amounts of cash and are held at amortised cost under the hold to collect classification, where they meet the hold to collect ‘solely payments of principal and interest’ test criteria under IFRS 9. Those not meeting these criteria are held at fair value through profit or loss. Cash and cash equivalents in the Consolidated Statement of Cash Flows include unsecured bank overdrafts at the balance sheet date where balances often fluctuate between a cash and overdraft position. Fixed deposits Fixed deposits, principally comprising funds held with banks and other financial institutions, are initially measured at fair value, plus direct transaction costs, and are subsequently measured at amortised cost using the effective interest method at each reporting date. Changes in carrying value are recognised in the Consolidated Statement of Comprehensive Income. Other investments Investments are classified as fair value through profit or loss (FVPL), unless the Group makes an irrevocable election at initial recognition for certain non-current equity investments to present changes in Other comprehensive income (FVOCI). If this election is made, there is no subsequent reclassification of fair value gains and losses to profit or loss following the derecognition of the investment. Bank and other borrowings The Group uses derivatives, principally interest rate swaps, to hedge the interest rate exposure inherent in a portion of its fixed interest rate debt. In such cases the Group will either designate the debt as FVPL when certain criteria are met or as the hedged item under a fair value hedge. Group Accounting Policies AstraZeneca Annual Report & Form 20-F Information 2023 157 Strategic Report Corporate Governance Financial Statements Additional Information |
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Group Accounting Policies continued If the debt instrument is designated as FVPL, the debt is initially measured at fair value (with direct transaction costs being included in profit as an expense) and is remeasured to fair value at each reporting date with changes in carrying value being recognised in profit (along with changes in the fair value of the related derivative), with the exception of changes in the fair value of the debt instrument relating to own credit risk which are recorded in Other comprehensive income in accordance with IFRS 9. Such a designation has been made where this significantly reduces an accounting mismatch which would result from recognising gains and losses on different bases. If the debt is designated as the hedged item under a fair value hedge, the debt is initially measured at fair value (with direct transaction costs being amortised over the life of the debt) and is remeasured for fair value changes in respect of the hedged risk at each reporting date with changes in carrying value being recognised in profit (along with changes in the fair value of the related derivative). If the debt is designated in a cash flow hedge, the debt is measured at amortised cost (with gains or losses taken to profit and direct transaction costs being amortised over the life of the debt). The related derivative is remeasured for fair value changes at each reporting date with the portion of the gain or loss on the derivative that is determined to be an effective hedge recognised in Other comprehensive income. The amounts that have been recognised in Other comprehensive income are reclassified to profit in the same period that the hedged forecast cash flows affect profit. The reclassification adjustment is included in Finance expense in the Consolidated Statement of Comprehensive Income. Other interest-bearing loans are initially measured at fair value (with direct transaction costs being amortised over the life of the loan) and are subsequently measured at amortised cost using the effective interest method at each reporting date. Changes in carrying value are recognised in the Consolidated Statement of Comprehensive Income. Derivatives Derivatives are initially measured at fair value (with direct transaction costs being included in profit as an expense) and are subsequently remeasured to fair value at each reporting date. Changes in carrying value of derivatives not designated in hedging relationships are recognised in profit or loss. The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral, for the benefit of the other, equivalent to the market valuation of all of the derivative positions above a predetermined threshold. Cash collateral received from counterparties is included within current Interest-bearing loans and borrowings within the Consolidated Statement of Financial Position. Cash collateral pledged to counterparties is recognised as a financial asset and is included in current Other investments within the Consolidated Statement of Financial Position. Cash collateral received is included in Movement in short-term borrowings within financing activities in the Consolidated Cash Flow Statement. Cash collateral paid is included in Movements in short-term investments within investing activities in the Consolidated Cash Flow Statement. The cash flow presentation of cash paid and received follows the Consolidated Statement of Financial Position presentation of the financial asset and financial liability that is recognised from posting the collateral. Foreign currencies Foreign currency transactions, being transactions denominated in a currency other than an individual Group entity’s functional currency, are translated into the relevant functional currencies of individual Group entities at average rates for the relevant monthly accounting periods, which approximate to actual rates. Monetary assets and liabilities arising from foreign currency transactions are retranslated at exchange rates prevailing at the reporting date. Exchange gains and losses on loans and on short-term foreign currency borrowings and deposits are included within Finance expense. Exchange differences on all other foreign currency transactions are recognised in Operating profit in the individual Group entity’s accounting records. Non-monetary items arising from foreign currency transactions are not retranslated in the individual Group entity’s accounting records. In the Consolidated Financial Statements, income and expense items for Group entities with a functional currency other than US dollars are translated into US dollars at average exchange rates, which approximate to actual rates, for the relevant accounting periods. Assets and liabilities are translated at the US dollar exchange rates prevailing at the reporting date. Exchange differences arising on consolidation are recognised in Other comprehensive income. If certain criteria are met, non-US dollar-denominated loans or derivatives are designated as net investment hedges of foreign operations. Exchange differences arising on retranslation of net investments, and of foreign currency loans which are designated in an effective net investment hedge relationship, are recognised in Other comprehensive income in the Consolidated Financial Statements. Foreign exchange derivatives hedging net investments in foreign operations are carried at fair value. Effective fair value movements are recognised in Other comprehensive income, with any ineffectiveness taken to profit. Gains and losses accumulated in the translation reserve will be recycled to profit and loss when the foreign operation is sold. Provisions Provisions are recognised when there is either a legal or constructive present obligation as a result of a past event, it is probable that an outflow of economic resources will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation. If the effect of the time value of money is material, provisions are discounted at the relevant pre-tax discount rate. Where provisions are discounted, the increase in the provision resulting from the passage of time is recognised as a finance cost. Litigation and environmental liabilities AstraZeneca is involved in legal disputes, the settlement of which may involve cost to the Group. A provision is made where an adverse outcome is probable and associated costs, including related legal costs, can be estimated reliably. Determining the timing of recognition of when an adverse outcome is probable is considered a key judgement, refer to Note 30 to the Financial Statements from page 204. Where it is considered that the Group is more likely than not to prevail, or in the extremely rare circumstances where the amount of the legal liability cannot be estimated reliably, legal costs involved in defending the claim are charged to the Consolidated Statement of Comprehensive Income as they are incurred. Where it is considered that the Group has a valid contract which provides the right to reimbursement (from insurance or otherwise) of legal costs and/or all or part of any loss incurred or for which a provision has been established, the amount expected to be received is recognised as an asset only when it is virtually certain. AstraZeneca is exposed to environmental liabilities relating to its past operations, principally in respect of soil and groundwater remediation costs. Provisions for these costs are made when there is a present obligation and where it is probable that expenditure on remedial work will be required and a reliable estimate can be made of the cost. Restructuring Restructuring costs are incurred in programmes that are planned and controlled by the Group which materially change either the scope of a business undertaken by the Group, or the manner in which that business is conducted. A provision for restructuring costs is recognised when a detailed formal plan is in place and has either been announced to those affected or has started to be implemented. The general recognition criteria for provisions must also be met, as described in the Provisions policy. 158 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Impairment The carrying values of non-financial assets, other than Inventories and Deferred tax assets, are reviewed at least annually to determine whether there is any indication of impairment. For Goodwill, Intangible assets under development and for any other assets where such indication exists, the asset’s recoverable amount is estimated based on the greater of its value in use and its fair value less cost to sell. In assessing the recoverable amount, the estimated future cash flows, adjusted for the risks associated with the probability of success specific to each asset, as well as inflationary impacts, are discounted to their present value using a nominal discount rate that reflects current market assessments of the time value of money, the general risks affecting the pharmaceutical industry and other risks specific to each asset. For the purpose of impairment testing, assets are grouped together into the smallest group of assets that generates cash inflows from continuing use that are largely independent of the cash flows of other assets. Impairment losses are recognised immediately in the Consolidated Statement of Comprehensive Income. Applicable accounting standards and interpretations issued but not yet adopted At the date of authorisation of these financial statements, certain new accounting standards and amendments were in issue relating to the following standards and interpretations but not yet adopted by the Group: > amendments to IAS 1 ‘Presentation of Financial Statements’, effective for periods beginning on or after 1 January 2024 – endorsed by the UK Endorsement Board (UKEB) on 21 July 2023 > amendments to IFRS 16 ‘Leases’, effective for periods beginning on or after 1 January 2024 – endorsed by the UKEB on 11 May 2023 > amendments to IAS 7 ‘Statement of Cash Flows’ and IFRS 7 ‘Financial Instruments: Disclosures’, effective for periods beginning on or after 1 January 2024 – endorsed by the UKEB on 28 November 2023 > amendments to IAS 21 ‘The Effects of Changes in Foreign Exchange Rates’, effective for periods beginning on or after 1 January 2025 – not endorsed by the UKEB. These new standards, amendments and interpretations are not expected to have a significant impact on the Group’s net results. Group Accounting Policies AstraZeneca Annual Report & Form 20-F Information 2023 159 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements 1 Revenue Product Sales 2023 2022 2021 Emerging Rest of Emerging Rest of Emerging Rest of US Markets Europe World Total US Markets Europe World Total US Markets Europe World Total $m $m $m $m $m $m $m $m $m $m $m $m $m $m $m Oncology: Tagrisso 2,276 1,621 1,120 782 5,799 2,007 1,567 1,023 847 5,444 1,780 1,336 986 913 5,015 Imfinzi 2,317 360 758 802 4,237 1,552 287 544 401 2,784 1,245 277 485 405 2,412 Lynparza 1,254 542 734 281 2,811 1,226 488 655 269 2,638 1,087 384 618 259 2,348 Calquence 1,815 98 493 108 2,514 1,657 45 286 69 2,057 1,089 20 111 18 1,238 Enhertu – 169 60 32 261 – 51 21 7 79 – 12 4 1 17 Orpathys – 44 – – 44 – 33 – – 33 – 16 – – 16 Truqap 6 – – – 6 – – – – – – – – – – Zoladex 14 687 133 118 952 15 657 133 122 927 13 619 147 169 948 Faslodex 31 142 28 96 297 17 159 55 103 334 30 167 113 121 431 Others 6 165 6 47 224 10 250 9 66 335 11 391 17 96 515 7,719 3,828 3,332 2,266 17,145 6,484 3,537 2,726 1,884 14,631 5,255 3,222 2,481 1,982 12,940 Cardiovascular, Renal & Metabolism: Farxiga 1,451 2,211 1,881 420 5,963 1,071 1,665 1,297 348 4,381 732 1,195 810 263 3,000 Brilinta 744 285 271 24 1,324 744 286 282 46 1,358 735 328 346 63 1,472 Lokelma 214 50 58 90 412 170 20 30 69 289 115 3 13 44 175 roxadustat – 271 – – 271 – 197 – – 197 – 174 – – 174 Andexxa 75 – 62 45 182 77 – 41 32 150 50 – 18 – 68 Crestor 55 862 52 138 1,107 65 794 41 148 1,048 80 775 52 189 1,096 Seloken/Toprol-XL 1 621 11 7 640 – 839 14 9 862 1 928 11 11 951 Onglyza 49 131 32 15 227 76 121 38 22 257 88 179 61 32 360 Bydureon 133 3 27 – 163 242 3 35 – 280 321 3 55 6 385 Others 30 152 109 5 296 34 194 128 10 366 52 195 146 14 407 2,752 4,586 2,503 744 10,585 2,479 4,119 1,906 684 9,188 2,174 3,780 1,512 622 8,088 Respiratory & Immunology: Symbicort 726 753 549 334 2,362 973 608 582 375 2,538 1,065 609 670 384 2,728 Fasenra 992 64 355 142 1,553 906 43 305 142 1,396 790 20 286 162 1,258 Breztri 383 161 81 52 677 239 92 33 34 398 115 55 7 26 203 Saphnelo 260 2 8 10 280 111 – 2 3 116 8 – – – 8 Tezspire – 1 48 37 86 – – 2 2 4 – – – – – Pulmicort 28 575 68 42 713 65 462 69 49 645 72 770 73 47 962 Bevespi 34 6 17 1 58 42 5 10 1 58 39 4 11 – 54 Daliresp/Daxas 42 3 8 1 54 176 3 9 1 189 207 4 15 1 227 Others 82 206 30 6 324 143 230 42 6 421 108 287 185 14 594 2,547 1,771 1,164 625 6,107 2,655 1,443 1,054 613 5,765 2,404 1,749 1,247 634 6,034 Vaccines & Immune Therapies: COVID-19 mAbs – 6 12 114 132 1,067 413 298 407 2,185 – 19 66 – 85 Vaxzevria – 10 2 – 12 79 729 365 625 1,798 64 2,240 1,035 578 3,917 Beyfortus 87 – 19 – 106 – – – – – – – – – – Synagis (1) 195 175 177 546 1 173 213 191 578 23 35 203 149 410 FluMist 23 1 188 4 216 21 1 151 2 175 27 2 222 2 253 109 212 396 295 1,012 1,168 1,316 1,027 1,225 4,736 114 2,296 1,526 729 4,665 Rare Disease: Soliris 1,734 424 670 317 3,145 2,180 301 805 476 3,762 1,068 170 439 197 1,874 Ultomiris 1,750 71 668 476 2,965 1,136 38 481 310 1,965 381 9 169 129 688 Strensiq 937 40 89 86 1,152 769 35 78 76 958 297 10 36 35 378 Koselugo 195 59 53 24 331 162 26 20 – 208 104 1 3 – 108 Kanuma 85 29 49 8 171 77 31 44 8 160 32 7 20 3 62 4,701 623 1,529 911 7,764 4,324 431 1,428 870 7,053 1,882 197 667 364 3,110 Other: Nexium 115 578 53 199 945 120 568 46 551 1,285 128 705 62 431 1,326 Others 18 153 52 8 231 24 220 77 19 340 43 212 109 14 378 133 731 105 207 1,176 144 788 123 570 1,625 171 917 171 445 1,704 Product Sales 17,961 11,751 9,029 5,048 43,789 17,254 11,634 8,264 5,846 42,998 12,000 12,161 7,604 4,776 36,541 160 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Rebates and chargebacks in the US The major market where estimates are seen as significant is the US. When invoicing Product Sales in the US, we estimate the rebates and chargebacks we expect to pay and we consider there to be a significant estimate associated with the rebates for Managed Care, Medicaid and Medicare Part D. The total adjustment in respect of prior year net US Product Sales revenue in 2023 was 1.0% (2022: 1.3%; 2021: 1.5%); this represents the difference between our prior year estimates for rebates and chargebacks against actual amounts paid for the US business. The most significant of these relate to the Medicaid and state programmes with an adjustment in respect of prior year net US Product Sales revenue in 2023 of 0.3% (2022: 0.5%; 2021: 0.4%) and Managed Care and Medicare of 0.5% (2022: 0.8%; 2021: 0.7%). The adjustment in respect of the prior year net US Product Sales revenue, excluding the Rare Disease therapy area in 2023, was 1.4% (2022: 1.6%; 2021: 1.8%), with Medicaid and state programmes of 0.4% (2022: 0.6%; 2021: 0.5%) and Managed Care and Medicare of 0.7% (2022: 1.1%; 2021: 0.8%). These values demonstrate the level of sensitivity; further meaningful sensitivity is not able to be provided due to the large volume of variables that contribute to the overall rebates, chargebacks, returns and other revenue accruals. These variables include assumptions in respect of aggregate future sales levels, segment mix and customers’ contractual performance, and in addition for Managed Care, US Medicaid and Medicare Part D, the channel inventory levels, and assumptions related to lag time. These assumptions are built up on a product-by-product and customer-by-customer basis, taking into account specific contract provisions coupled with expected performance, and are then aggregated into a weighted average rebate accrual rate for each of our products. Accrual rates are reviewed and adjusted on an as-needed basis. There may be further adjustments when actual rebates are invoiced based on utilisation information submitted to AstraZeneca (in the case of contractual rebates) and claims/invoices are received (in the case of regulatory rebates and chargebacks). Alliance Revenue 2023 2022 2021 $m $m $m Enhertu 1,022 523 197 Tezspire 259 79 – Beyfortus 57 – – Vaxzevria: royalties – 76 64 Other royalty income 81 68 70 Other Alliance Revenue 9 9 57 1,428 755 388 Collaboration Revenue 2023 2022 2021 $m $m $m Lynparza: regulatory milestones 245 355 – Lynparza: sales milestones – – 400 COVID-19 mAbs: licence fees 180 – – Farxiga: sales milestones 29 – – tralokinumab: sales milestones 20 110 – Beyfortus: regulatory milestones 71 25 – Beyfortus: sales milestones 27 – – Nexium: sale of rights – 62 75 Other Collaboration Revenue 22 46 13 594 598 488 2 Operating profit Operating profit includes the following significant items: Cost of sales In 2023, Cost of sales includes a charge of $114m (2022: charge of $3,484m) in relation to the release, in line with sales, of fair value uplift to inventory that was recognised under IFRS 3 ‘Business Combinations’ upon the acquisition of Alexion (see Note 27). During the year, $nil government grants were recognised within Cost of sales (2022: $nil; 2021: $290m). The grants recognised in 2021 related to funding of manufactured Vaxzevria product for the US government, which expired prior to being accepted by the FDA. Selling, general and administrative expense In 2023, Selling, general and administrative expense includes a charge of $520m (2022: charge of $182m; 2021: charge of $42m) resulting from changes in the fair value of contingent consideration arising from the acquisition of the diabetes alliance from BMS. These adjustments reflect revised estimates for future sales performance for the products acquired and, as a result, revised estimates for future royalties payable. In 2023, Selling, general and administrative expense also includes a charge of $1,013m (2022: charge of $789m; 2021: charge of $48m) relating to a number of legal proceedings, including settlements in various jurisdictions in relation to several marketed products (see Note 30). Research and development expense: Government grants During the year $74m (2022: $113m; 2021: $531m) of government grants were recognised within Research and development expense. The grants recognised relate to funding for Research and development and related expenses for COVID-19 mAbs of $nil (2022: $112m; 2021: $222m) and Vaxzevria of $74m (2022: $1m; 2021: $309m). Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 161 Strategic Report Corporate Governance Financial Statements Additional Information |
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2 Operating profit continued Notes to the Group Financial Statements continued Other operating income and expense 2023 2022 2021 $m $m $m Royalty income 107 59 62 Gains on disposal of intangible assets 251 104 513 Gains on disposal of investments in associates and joint ventures – – 776 Net gains/(losses) on disposal of other non-current assets 41 112 (4) Update to the contractual relationships for Beyfortus (nirsevimab) 712 – – Other income1 393 439 453 Other expense (164) (200) (308) Other operating income and expense 1,340 514 1,492 1 Other income in 2023 includes $75m of income from Allergan Plc. in respect of the development of brazikumab (2022: $138m; 2021: $99m). Gains on disposal of intangible assets in 2023 includes $241m on disposal of commercial rights to Pulmicort Flexhaler to Cheplapharm in the US. Gains on disposal of intangible assets in 2021 includes $317m on disposal of rights to Crestor in over 30 countries in Europe, except in the UK and Spain. Net gains/(losses) on disposal of other non-current assets in 2022 includes a $125m gain in respect of the Waltham R&D site sale and leaseback in MA, US (see Note 8). Gains on disposal of investments in associates and joint ventures in 2021 relates to the disposal of the 26.7% ownership in Viela Bio, as part of the acquisition of Viela Bio by Horizon Therapeutics plc. AstraZeneca received cash proceeds and profit of $776m upon closing, with the profit recorded as Other operating income. As part of the total consideration received in respect of the agreement to sell US rights to Synagis in 2019, $400m in total has been received related to the rights to participate in the future cash flows from the US profits or losses for Beyfortus (nirsevimab), with $190m cash inflows in 2023 primarily relating to a cash receipt from Sobi following achievement of a regulatory milestone. At 31 December 2022, the full amount of $522m was recognised as a financial liability within non-current Other payables (the Profit Participation Liability) as the Group had not fully transferred the risks and rewards of the underlying cash flows arising from Beyfortus to Sobi. All associated cash flows have been presented within investing activities as the Group has received the cash in exchange for agreeing to transfer future cash flows relating to an intangible asset. In 2023, the contractual relationship between AstraZeneca and Sobi relating to future sales of Beyfortus in the US was replaced by a royalty relationship between Sanofi and Sobi. As a result, the Profit Participation Liability was extinguished and derecognised from the Consolidated Statement of Financial Position, with a gain of $712m recorded in Other operating income and expense. In 2021, as a result of the Probability of Technical/Regulatory Success unwind, an increase of $114m to the Profit Participation Liability was recorded with the cost recorded in Other operating expense. Restructuring costs During 2023, the Group has incurred $467m of net restructuring costs, of which $362m resulted from activities that are part of the Post Alexion Acquisition Group Review (PAAGR), bringing the cumulative charges under this programme to $2,067m. Costs in 2023 included $109m within Cost of sales due to the rationalisation of our manufacturing capacity and footprint across certain production sites, $207m within Selling, general and administrative expense in relation to HR, Finance, IT & other integration costs as well as some severance costs, $212m within Research and development expense in relation to the transformation of clinical, regulatory and other R&D data and systems, partially offset by income of $61m in Other operating income and expense generated from the disposal of assets impacted by the restructuring. In conjunction with the acquisition of Alexion in 2021, the enlarged Group initiated the PAAGR; a global restructuring programme aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments. During 2023, the Group has identified all remaining activities and finalised the scope of the programme. This includes the commencement of work on the planned upgrade of the Group’s Enterprise Resource Planning IT systems (Axial Project), which is expected to be substantially complete by the end of 2030. The Group has also continued to progress other legacy restructuring programmes. Total restructuring costs in 2023 includes an impairment charge to Property, plant and equipment of $7m (2022: reversal of $4m; 2021: charge of $343m), impairment of Right-of-use assets of $13m (2022: $nil; 2021: $nil) and no impairment of Intangible assets (software development costs) (2022: reversal $17m; 2021: charge of $16m). The tables below show the costs that have been charged in respect of restructuring programmes by cost category and type. Severance provisions are detailed in Note 21. 2023 2022 2021 $m $m $m Cost of sales 109 266 722 Distribution expense – 2 – Research and development expense 212 111 223 Selling, general and administrative expense 207 405 338 Other operating income and expense (61) (67) – Total charge 467 717 1,283 162 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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2023 2022 2021 $m $m $m Severance costs 57 187 217 Accelerated depreciation and impairment charges 68 135 371 Other1 342 395 695 Total charge 467 717 1,283 1 Other costs are those incurred in designing and implementing the Group’s various restructuring initiatives, including costs of integrating systems, structure and processes as part of the PAAGR, costs relating to the Alexion acquisition, internal project costs and external service fees. Financial instruments Included within Operating profit are the following net gains and losses on financial instruments: 2023 2022 2021 $m $m $m Gains/(losses) on forward foreign exchange contracts 42 150 (21) Losses on receivables and payables (260) (203) (42) Total (218) (53) (63) Impairment charges Details of impairment charges for 2023, 2022 and 2021 are included in Notes 7, 8 and 10. 3 Finance income and expense 2023 2022 2021 $m $m $m Finance income Returns on deposits and equity securities 291 78 12 Fair value gains on debt and interest rate swaps 43 14 – Interest income on income tax balances 10 3 31 Total 344 95 43 Finance expense Interest on debt, leases and other financing costs (1,132) (889) (774) Net interest on post-employment defined benefit plan net liabilities (Note 22) (38) (29) (26) Net exchange losses (34) (16) (20) Discount unwind on contingent consideration arising from business combinations (Note 20) (132) (168) (226) Discount unwind on other long-term liabilities1 (200) (216) (248) Fair value losses on debt and interest rate swaps (3) – (4) Interest expense on income tax balances (87) (28) (2) Total (1,626) (1,346) (1,300) Net finance expense (1,282) (1,251) (1,257) 1 Included within Discount unwind on other long-term liabilities is $55m relating to the Acerta Pharma share purchase liability (2022: $108m; 2021: $161m) and the discount unwind of other payables of $100m (2022: $nil; 2021: $nil) that have arisen from intangible asset additions, see Note 20 for further details. There was no interest capitalised during the year. Financial instruments Included within finance income and expense are the following net gains and losses on financial instruments: 2023 2022 2021 $m $m $m Interest and fair value adjustments in respect of debt designated at fair value through profit or loss, net of derivatives 13 (9) (5) Interest and changes in carrying values of debt designated as hedged items in fair value hedges, net of derivatives – – (9) Interest and fair value changes on fixed and short-term deposits, equity securities, other derivatives and tax balances 177 54 16 Interest on debt, commercial paper, overdrafts and lease liabilities held at amortised cost (1,004) (837) (738) The interest rate fair value hedges were closed in 2021. Fair value gain or loss of $nil (2022: $nil; 2021: loss of $33m) on interest rate fair value hedging instruments and $nil fair value gain or loss (2022: $nil; 2021: gain of $29m) on the related hedged items have been included within Interest and changes in carrying values of debt designated as hedged items in fair value hedges, net of derivatives. Fair value loss of $1m (2022: loss of $25m; 2021: loss of $19m) on derivatives related to debt instruments designated at FVPL and $7m fair value gain (2022: gain of $26m; 2021: gain of $19m) on debt instruments designated at FVPL have been included within Interest and fair value adjustments in respect of debt designated at fair value through profit or loss, net of derivatives. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 163 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 4 Taxation Taxation charge/(credit) recognised in the Consolidated Statement of Comprehensive Income is as follows: 2023 2022 2021 $m $m $m Current tax Current year 2,417 1,823 1,200 Adjustment to prior years 28 (187) (5) Total 2,445 1,636 1,195 Deferred tax Origination and reversal of temporary differences (1,473) (2,563) (1,417) Adjustment to prior years (34) 135 (158) Total (1,507) (2,428) (1,575) Taxation charge/(credit) recognised in the profit for the year 938 (792) (380) Taxation credit/(charge) recognised in Other comprehensive income is as follows: 2023 2022 2021 $m $m $m Current and deferred tax Items that will not be reclassified to profit or loss: Remeasurement of the defined benefit liability 102 (231) (117) Equity investments measured at fair value through Other comprehensive income (1) 15 27 Movement in deferred taxes relating to changes in tax rates – – 195 Total 101 (216) 105 Items that may be reclassified subsequently to profit or loss: Foreign exchange arising on designated liabilities in net investment hedges (24) 73 43 Fair value movement on cash flow hedges 12 – (5) Movement in deferred taxes relating to changes in tax rates – – 8 Total (12) 73 46 Taxation credit/(charge) recognised in Other comprehensive income 89 (143) 151 The reported tax rate in the year was 14% and included a favourable adjustment of $828m to deferred taxes arising from a UK group company undertaking a routine intragroup purchase of certain intellectual property. This intragroup purchase resulted in additional amortisable tax basis in the UK which can be fully utilised against forecast UK taxable profits. Deferred tax has been recognised on this additional tax basis in the year. This is offset by updates to tax liabilities following progress of reviews by tax authorities and administrative appeal processes and derecognition of deferred tax assets following changes to forecast taxable income of specific subsidiaries. The income tax paid for the year was $2,366m. Taxation has been provided at current rates on the profits earned for the years covered by the Group Financial Statements. The 2023 prior year current tax adjustment relates mainly to tax accrual to tax return adjustments and updates to provisions for tax contingencies. The 2022 prior year current tax adjustment relates mainly to tax accrual to tax return adjustments and updates to provisions for tax contingencies. The 2021 prior year current tax adjustment relates mainly to tax accrual to tax return adjustments. The 2023 prior year deferred tax adjustment relates mainly to tax accrual to tax return adjustments and adjustments to the recognition of deferred tax assets. The 2022 prior year deferred tax adjustments relate mainly to tax accrual to tax return adjustments and updates to provisions for tax contingencies. The 2021 prior year deferred tax adjustments relate mainly to tax accrual to tax return adjustments and updates to estimates of prior year tax liabilities following settlements with tax authorities. To the extent that dividends remitted from overseas subsidiaries, joint ventures and associates are expected to result in additional taxes, appropriate amounts have been provided for. Unremitted earnings or differences in the carrying value and tax basis of investments may be liable to additional taxes if distributed as dividends or on a liquidation event. Deferred tax is provided for such differences in relation to Group entities where management is intending to remit earnings in the foreseeable future. The aggregate amount of gross temporary differences associated with investments in subsidiaries, partnerships and branches for which deferred tax liabilities have not been recognised totalled approximately $7,565m at 31 December 2023, $3,221m of which has a corresponding deductible temporary difference of the same gross value which is not recognised as it is not probable of reversing in the foreseeable future but on which different tax rates apply. 164 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Factors affecting future tax charges As a group with worldwide operations, AstraZeneca is subject to several factors that may affect future tax charges, principally the levels and mix of profitability in different jurisdictions, transfer pricing regulations, tax rates imposed and tax regime reforms. On 11 July 2023, Finance (No.2) Act 2023 was enacted in the UK, introducing a global minimum effective tax rate of 15%. The legislation implements a domestic top-up tax and a multinational top-up tax, effective for accounting periods starting on or after 31 December 2023. A Pillar 2 Effective Tax Rate (ETR) is calculated for every jurisdiction in which the Group operates and Pillar 2 Income Taxes will arise when the Pillar 2 ETR is less than 15%. Pillar 2 Income Taxes could be payable in the UK, or the local jurisdiction if it has introduced a Qualifying Domestic Minimum top-up Tax. AstraZeneca is continuing to monitor potential impacts as further guidance is published by the OECD and territories implement legislation to enact the rules. Management has performed an assessment of the impact of the UK’s Pillar 2 rules based on our 2023 data and no Pillar 2 Income Taxes are expected to arise for most jurisdictions in which the Group operates. It is anticipated that AstraZeneca may, in some jurisdictions, incur additional tax liabilities, but the effect on the reported tax charge is reasonably estimated to be immaterial. The Group has applied the exemption under the IAS 12 ‘Income Taxes’ amendment for recognising and disclosing information about deferred tax assets and liabilities related to top-up income taxes. Tax reconciliation to UK statutory rate The table below reconciles the UK statutory tax charge to the Group’s total tax charge/(credit): 2023 2022 2021 $m $m $m Profit/(loss) before tax 6,899 2,501 (265) Notional taxation charge at UK corporation tax rate of 23.5% (2022: 19%; 2021: 19%) 1,621 475 (50) Differences in effective overseas tax rates1 (224) (59) 1 Deferred tax (credit)/charge relating to change in tax rates2 (66) (108) 54 Unrecognised deferred tax asset3 341 68 32 Items not deductible for tax purposes 46 90 208 Items not chargeable for tax purposes – – (163) Intellectual Property incentive regimes4 (367) (265) – Other items5 (406) (941) (299) Adjustments in respect of prior years6 (7) (52) (163) Total tax charge/(credit) for the year 938 (792) (380) 1 Includes the impact of the reversal of a $1.9bn deferred tax liability that was recognised in a previous business combination (31 December 2023: $0.9bn) and originated in goodwill. Some of this liability reverses in an innovation incentive regime and gives rise to a post-acquisition benefit to the tax charge that is not material year-on-year. Determining the cumulative post-acquisition benefit over the life of the asset involves estimates and judgements as the amount of income that qualifies for the IP incentive regime varies. The actual tax rates applied over the life of the asset are expected to be a blend between the Dutch statutory tax rate and intellectual property incentive regime rate. 2 The 2023 item relates to the impact of the difference in the UK current and deferred tax rates during 2023. The 2022 item relates to the impact of the US state tax rate change and the impact of the difference in the UK current tax and deferred tax rates during 2022. The 2021 item mainly relates to substantive enactment of the increase in UK Corporation Tax rate from 19% to 25% effective 1 April 2023 and the increase in the Dutch Corporate Income Tax rate from 25% to 25.8% effective 1 January 2022. 3 This includes the derecognition of deferred tax assets where it is no longer probable that there will be sufficient forecast future profits to utilise the assets. 4 Previously reported within the line Items not deductible for tax purposes. 5 Other items in 2023 include a favourable adjustment of $828m to deferred taxes arising from a UK company undertaking an intragroup purchase of certain intellectual property (see page 164 for more information) offset by a charge of $422m mainly relating to updates to tax liabilities following progress of reviews by tax authorities, administrative appeal processes and adjustments arising on expiry of the relevant statute of limitations (see Note 30 for more details). Other items in 2022 includes a one-time favourable net adjustment of $876m to deferred taxes arising from an internal reorganisation to integrate the Alexion organisation which took place in 2022 and a credit of $65m relating to the reduction of tax liabilities arising from adjustments on expiry of the relevant statute of limitations. Other items in 2021 relate to a net credit of $299m relating to the reduction of tax liabilities arising from updates to estimates of prior year tax liabilities following settlements with tax authorities and on expiry of the relevant statute of limitations partially offset by a provision for transfer pricing and other contingencies. 6 Further details explaining the adjustments in respect of prior years are set out on page 164. AstraZeneca is domiciled in the UK but operates in other countries where the tax rates and laws are different to those in the UK. The impact on differences in effective overseas tax rates on the Group’s overall tax charge is noted above. Profits arising from our manufacturing operation in Puerto Rico are granted special status and are taxed at a reduced rate compared with the normal rate of tax in that territory under a tax incentive grant continuing until 2031. The Group receives intellectual property incentives in certain jurisdictions, resulting in a reduction to the tax charge in the income statement of $367m in 2023. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 165 Strategic Report Corporate Governance Financial Statements Additional Information |
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4 Taxation continued Notes to the Group Financial Statements continued Deferred tax The total movement in the net deferred tax balance in the year was $1,555m. The movements are as follows: Intangibles, Pension and Elimination of Losses and Property, plant post-retirement unrealised profit Untaxed tax credits Accrued and equipment1 benefits on inventory reserves2 carried forward expenses Other Total $m $m $m $m $m $m $m $m Net deferred tax balance at 1 January 2021 (2,627) 656 1,807 (801) 714 660 111 520 Income statement 782 (166) (59) (139) 307 697 153 1,575 Other comprehensive income 52 83 – – – – 40 175 Equity – – – – – 4 10 14 Additions through business combinations3 (3,744) 13 166 – 507 (1,263) 147 (4,174) Exchange 57 (33) (53) 78 (10) (13) (12) 14 Net deferred tax balance at 31 December 2021 (5,480) 553 1,861 (862) 1,518 85 449 (1,876) Income statement4 1,414 (55) 274 38 (126) 778 105 2,428 Other comprehensive income 72 (231) – – – – 16 (143) Equity – – – – – – 38 38 Exchange 63 (36) (111) 108 (134) 17 (35) (128) Net deferred tax balance at 31 December 2022 (3,931) 231 2,024 (716) 1,258 880 573 319 Income statement4 1,518 (69) 426 96 (308) (23) (133) 1,507 Other comprehensive income (16) 106 – – – – (23) 67 Equity – – – – – – (21) (21) Additions (24) – – – 50 – (1) 25 Exchange (38) 15 (64) (40) 106 32 (34) (23) Net deferred tax balance at 31 December 20235 (2,491) 283 2,386 (660) 1,106 889 361 1,874 1 Includes deferred tax assets of $507m on liabilities in respect of intangibles and $188m on lease liabilities in respect of right-of-use assets. 2 Untaxed reserves relate to taxable profits where the tax liability is deferred to later periods. 3 The deferred tax liability of $4,174m relates to deferred tax on purchase accounting adjustments arising from the acquisition of Alexion (Note 27). Accrued expenses includes the deferred tax on the purchase accounting of inventory. 4 The Income statement movement in 2023 includes $828m arising from a UK company undertaking an intragroup purchase of certain intellectual property (see page 164 for further details). The Income statement movement in 2022 includes the aforementioned net adjustment to deferred taxes of $876m arising on the internal legal entity reorganisation to integrate the Alexion organisation, the majority of which arises on Intangibles, Property, plant and equipment. 5 The Group recognises deferred tax assets to the extent that there are either taxable temporary differences or that it is probable that sufficient future taxable profits will arise, against which these deductible temporary differences can be utilised. The US includes a net deferred tax asset of $142m and the UK includes a net deferred tax asset of $1,723m as at 31 December 2023 which includes tax losses and other deductible temporary differences. The Group has performed an assessment of recovery of deferred tax assets and for these respective entities, the Group has forecasted future taxable profits and considers that it is probable that sufficient future taxable profits will arise against which these deductible temporary differences can be utilised. In arriving at these forecasts, the Group has reviewed the Group-level budgets and forecasts and the ability of those entities to generate future income from developing and commercialising products, including local tax laws and the scheduling of reversal of deductible temporary differences. Deferred tax assets are recognised on the basis there is sufficient forecast future taxable profits arising from the performance of on-market products and pipeline assets, including Imfinzi. For the UK, losses are forecast to be utilised within five years. For the US, recognised deferred taxes on losses and other items are forecast to be utilised within 15 years. It is considered that these sources of income are sufficiently predictable or diversified to support these recognition periods. A sensitivity assessment has been performed which shows that a change in profit of 10% results in an immaterial adjustment to the amount of deferred tax asset recognised. Assessing the availability of future taxable income to support recognition of deferred tax assets relies upon our Group forecasts and changes in these Group forecasts will impact the recoverability of deferred tax assets. To the extent that there are neither taxable temporary differences nor sufficient taxable profits, no deferred tax asset is recognised and details of unrecognised deferred tax assets are included in the table below. The net deferred tax balance, before the offset of balances within countries, consists of: Intangibles, Pension and Elimination of Losses and Property, plant post-retirement unrealised profit Untaxed tax credits Accrued and equipment benefits on inventory reserves carried forward expenses Other Total $m $m $m $m $m $m $m $m Deferred tax assets at 31 December 2021 1,476 574 1,910 – 1,571 1,117 618 7,266 Deferred tax liabilities at 31 December 2021 (6,956) (21) (49) (862) (53) (1,032) (169) (9,142) Net deferred tax balance at 31 December 2021 (5,480) 553 1,861 (862) 1,518 85 449 (1,876) Deferred tax assets at 31 December 2022 1,499 276 2,048 – 1,274 1,005 609 6,711 Deferred tax liabilities at 31 December 2022 (5,430) (45) (24) (716) (16) (125) (36) (6,392) Net deferred tax balance at 31 December 2022 (3,931) 231 2,024 (716) 1,258 880 573 319 Deferred tax assets at 31 December 2023 1,883 313 2,386 – 1,141 1,011 488 7,222 Deferred tax liabilities at 31 December 2023 (4,374) (30) – (660) (35) (122) (127) (5,348) Net deferred tax balance at 31 December 2023 (2,491) 283 2,386 (660) 1,106 889 361 1,874 Analysed in the Consolidated Statement of Financial Position, after offset of balances within countries, as follows: 2023 2022 2021 $m $m $m Deferred tax assets 4,718 3,263 4,330 Deferred tax liabilities (2,844) (2,944) (6,206) Net deferred tax balance 1,874 319 (1,876) 166 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Unrecognised deferred tax assets Deferred tax assets (DTA) of $1,251m (2022: $807m; 2021: $719m) have not been recognised in respect of deductible temporary differences because it is not probable that future taxable profit will be available against which the Group can utilise the benefits therefrom. 2023 2023 2022 2022 2021 2021 Temporary Unrecognised Temporary Unrecognised Temporary Unrecognised differences DTA differences DTA differences DTA $m $m $m $m $m $m Temporary differences expiring: Within 10 years 87 22 104 26 4 1 More than 10 years 153 32 153 32 53 11 Indefinite 2,788 595 686 163 300 79 3,028 649 943 221 357 91 Tax credits and State tax losses expiring: Within 10 years 152 115 101 More than 10 years 363 384 441 Indefinite 87 87 86 602 586 628 Total 1,251 807 719 5 Earnings per $0.25 Ordinary Share 2023 2022 2021 Profit for the year attributable to equity holders ($m) 5,955 3,288 112 Basic earnings per Ordinary Share $3.84 $2.12 $0.08 Diluted earnings per Ordinary Share $3.81 $2.11 $0.08 Weighted average number of Ordinary Shares in issue for basic earnings (millions) 1,549 1,548 1,418 Dilutive impact of share options outstanding (millions) 13 12 9 Diluted weighted average number of Ordinary Shares in issue (millions) 1,562 1,560 1,427 The earnings figures used in the calculations above are post-tax. The weighted average number of Ordinary Shares in issue is calculated by taking the number of Ordinary Shares outstanding each day weighted by the number of days that those shares were outstanding. 6 Segment information The Group has reviewed its assessment of reportable segments under IFRS 8 ‘Operating Segments’ and concluded that the Group continues to have one reportable segment. This determination is considered to be a Key Judgement and this judgement has been taken with reference to the following factors: 1 The level of integration across the different functions of the Group’s pharmaceutical business: AstraZeneca is engaged in a single business activity of pharmaceuticals and the Group does not have multiple operating segments. AstraZeneca’s pharmaceuticals business consists of the discovery and development of new products, which are then manufactured, marketed and sold. All of these functional activities take place (and are managed) globally on a highly integrated basis. These individual functional areas are not managed separately. 2 The identification of the Chief Operating Decision Maker (CODM) and the nature and extent of the financial information reviewed by the CODM: The SET, established and chaired by the CEO, is the vehicle through which the CEO exercises the authority delegated to him from the Board for the management, development and performance of AstraZeneca as a whole. It is considered that the SET is AstraZeneca’s Chief Operating Decision Making body (as defined by IFRS 8). The operation of the SET is principally driven by the management of the Commercial operations, R&D, manufacturing and supply and enabling functions. All significant operating decisions are undertaken by the SET. While members of the SET have responsibility for implementation of decisions in their respective areas, operating decision making is at SET level as a whole. Where necessary, these are implemented through cross-functional sub-committees that consider the Group-wide impact of a new decision. For example, product launch decisions would be initially considered by the SET and, on approval, passed to an appropriate sub team for implementation. The ability of the enterprise to develop, produce, deliver and commercialise a wide range of pharmaceutical products are central to the SET decision-making process. In assessing performance, the SET reviews financial information on an integrated basis for the Group as a whole, substantially in the form of, and on the same basis as, the Group’s IFRS Financial Statements. The high upfront cost of discovering and developing new products, coupled with the relatively insignificant and stable unit cost of production, means that there is not the clear link that exists in many manufacturing businesses between the revenue generated on an individual product sale and the associated cost and hence margin generated on a product. Consequently, the profitability of individual drugs or classes of drugs is not considered a key measure of performance for the business and is not monitored by the SET. The focus of additional financial information reviewed is at brand sales and Gross Margin level within specific geographies. Expenditure analysis is completed for the science units, operations and enabling functions; there is no allocation of these centrally managed Group costs to the individual product or brands. The bonus of SET members’ continues to be derived from the Group scorecard outcome as discussed in our Directors’ Remuneration Report. 3 How resources are allocated: Resources are allocated on a Group-wide basis according to need. In particular, capital expenditure, in-licensing, and R&D resources are allocated between activities on merit, based on overall therapeutic considerations and strategy under the aegis of the Group’s Early-Stage Product Committees and Late-Stage Product Committees. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 167 Strategic Report Corporate Governance Financial Statements Additional Information |
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6 Segment information continued Notes to the Group Financial Statements continued Geographic areas The following table shows information for Total Revenue by geographic area and material countries. The additional tables show the Operating profit and Profit before tax made by companies located in that area, together with Non-current assets, Total assets, Assets acquired, Net operating assets, and Property, plant and equipment owned by the same companies. Product Sales by geographic market are included in the area/country where the legal entity resides and from which those sales were made. Total Revenue 2023 2022 2021 $m $m $m UK 3,368 3,117 3,245 Rest of Europe France 1,152 1,107 915 Germany 2,099 1,902 1,486 Italy 813 735 577 Spain 847 738 578 Sweden 1,704 1,721 2,322 Others 3,110 2,706 1,949 9,725 8,909 7,827 The Americas Canada 967 1,166 772 US 18,121 17,278 12,047 Others 1,683 1,175 1,203 20,771 19,619 14,022 Asia, Africa & Australasia Australia 390 571 547 China 5,872 5,743 6,002 Japan 3,640 3,986 3,395 Others 2,045 2,406 2,379 11,947 12,706 12,323 Total Revenue 45,811 44,351 37,417 Total Revenue outside of the UK totalled $42,443m for the year ended 31 December 2023 (2022: $41,234m; 2021: $34,172m). Operating profit/(loss) Profit/(loss) before tax 2023 2022 2021 2023 2022 2021 $m $m $m $m $m $m UK 665 1,120 (950) (577) 272 (1,477) Rest of Europe 4,885 2,945 2,999 4,999 2,709 2,682 The Americas 1,495 (954) (1,936) 1,328 (1,140) (2,401) Asia, Africa & Australasia 1,148 646 943 1,149 660 931 Continuing operations 8,193 3,757 1,056 6,899 2,501 (265) Non-current assets1, 2 Total assets 2023 2022 2021 2023 2022 2021 $m $m $m $m $m $m UK 8,626 8,208 7,310 19,616 16,786 16,615 Rest of Europe 32,905 34,301 38,286 40,638 40,669 48,383 The Americas 26,524 25,425 26,333 34,754 32,990 34,301 Asia, Africa & Australasia 910 929 1,078 6,111 6,038 6,064 Continuing operations 68,965 68,863 73,007 101,119 96,483 105,363 Assets acquired3 Net operating assets4 2023 2022 2021 2023 2022 2021 $m $m $m $m $m $m UK 812 2,301 810 5,275 3,863 3,239 Rest of Europe 1,770 522 26,527 32,920 32,726 40,161 The Americas 1,925 421 10,810 22,746 23,290 24,786 Asia, Africa & Australasia 117 51 94 1,405 1,895 736 Continuing operations 4,624 3,295 38,241 62,346 61,774 68,922 1 Non-current assets exclude Deferred tax assets and Derivative financial instruments. 2 The Group has revised the presentation of Non-current assets to exclude certain financial assets and post-employment benefit assets which previously had been included in this disclosure. This resulted in a decrease in 2022 of $1,690m and in 2021 of $1,680m. 3 Included in Assets acquired are those assets that are expected to be used during more than one period (Property, plant and equipment, Goodwill and Intangible assets) and include those acquired through business combinations (Note 27). 4 Net operating assets exclude short-term investments, cash, short-term borrowings, loans, Derivative financial instruments, Retirement benefit obligations and non-operating receivables and payables. 168 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Property, plant and equipment 2023 2022 2021 $m $m $m UK 2,831 2,526 2,542 Ireland 1,164 1,040 969 Sweden 1,678 1,472 1,593 US 2,371 2,176 2,660 Rest of the world 1,358 1,293 1,419 Continuing operations 9,402 8,507 9,183 Geographic markets The table below shows Product Sales in each geographic market in which customers are located. 2023 2022 2021 $m $m $m UK 978 996 1,206 Rest of Europe 8,201 7,503 6,792 The Americas 20,855 20,126 14,893 Asia, Africa & Australasia 13,755 14,373 13,650 Continuing operations 43,789 42,998 36,541 Product Sales are recognised when control of the goods has been transferred to a third party. A significant proportion of this is upon delivery of the products to wholesalers. One wholesaler (2022: one; 2021: one) individually represented greater than 10% of Product Sales. The value of Product Sales to this wholesaler was $6,513m (2022: $5,387m; 2021: $4,862m). 7 Property, plant and equipment Assets in Total Property, Land and Plant and course of plant and buildings equipment construction equipment $m $m $m $m Cost At 1 January 2021 5,851 7,738 2,478 16,067 Additions through business combinations (Note 27) 542 339 254 1,135 Capital expenditure 9 31 1,112 1,152 Transfer of assets into use 236 611 (847) – Disposals and other movements (92) (469) (200) (761) Exchange adjustments (169) (347) (69) (585) At 31 December 2021 6,377 7,903 2,728 17,008 Capital expenditure 5 19 1,042 1,066 Transfer of assets into use 226 683 (909) – Transfer of Assets held for sale (Note 18) (434) (293) – (727) Disposals and other movements (425) (146) 28 (543) Exchange adjustments (309) (610) (236) (1,155) At 31 December 2022 5,440 7,556 2,653 15,649 Additions through business combinations (Note 27) 2 10 – 12 Capital expenditure 9 43 1,402 1,454 Transfer of assets into use 959 1,158 (2,117) – Disposals and other movements (6) (255) (11) (272) Exchange adjustments 65 192 118 375 At 31 December 2023 6,469 8,704 2,045 17,218 Depreciation and impairment At 1 January 2021 2,826 4,990 – 7,816 Depreciation charge for the year 231 493 – 724 Impairment (reversal)/charge (1) 121 223 343 Disposals and other movements (74) (428) (223) (725) Exchange adjustments (105) (228) – (333) At 31 December 2021 2,877 4,948 – 7,825 Depreciation charge for the year 286 566 – 852 Impairment charge/(reversal) 20 8 (28) – Transferred to Assets held for sale (Note 18) (300) (277) – (577) Disposals and other movements (227) (188) 28 (387) Exchange adjustments (167) (404) – (571) At 31 December 2022 2,489 4,653 – 7,142 Depreciation charge for the year 241 492 – 733 Impairment charge 4 4 – 8 Disposals and other movements (13) (220) – (233) Exchange adjustments 44 122 – 166 At 31 December 2023 2,765 5,051 – 7,816 Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 169 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued Assets in Total Property, Land and Plant and course of plant and buildings equipment construction equipment $m $m $m $m Net book value At 31 December 2021 3,500 2,955 2,728 9,183 At 31 December 2022 2,951 2,903 2,653 8,507 At 31 December 2023 3,704 3,653 2,045 9,402 Impairment charges in 2021 totalling $343m were recognised for Plant and equipment and Assets in course of construction due to the rationalisation of our manufacturing capacity and footprint across certain production sites as a result of restructuring programmes, including the PAAGR (see Note 2). These charges were recognised in Cost of sales. The revised carrying value of the impacted assets is $nil, under fair value less costs to sell. 2023 2022 2021 $m $m $m The net book value of land and buildings comprised: Freeholds 2,976 2,555 2,985 Leaseholds 728 396 515 8 Leases Right-of-use assets Total Land and Motor Right-of-use buildings vehicles Other assets $m $m $m $m Cost At 1 January 2021 735 272 36 1,043 Additions through business combinations (Note 27) 255 8 – 263 Additions – separately acquired 145 98 2 245 Disposals and other movements 25 (44) (4) (23) Exchange adjustments (27) (13) (1) (41) At 31 December 2021 1,133 321 33 1,487 Additions through business combinations (Note 27) 4 – – 4 Additions – separately acquired 140 81 14 235 Disposals and other movements (33) (58) (13) (104) Exchange adjustments (62) (15) (2) (79) At 31 December 2022 1,182 329 32 1,543 Additions through business combinations (Note 27) 8 – – 8 Additions – separately acquired 220 219 5 444 Disposals and other movements (71) (57) (2) (130) Exchange adjustments 13 4 1 18 At 31 December 2023 1,352 495 36 1,883 Depreciation and impairment At 1 January 2021 247 117 13 377 Depreciation charge for the year 144 85 6 235 Disposals and other movements (54) (42) – (96) Exchange adjustments (11) (6) – (17) At 31 December 2021 326 154 19 499 Depreciation charge for the year 160 80 6 246 Impairment charge 2 – – 2 Disposals and other movements (54) (50) (10) (114) Exchange adjustments (23) (8) (1) (32) At 31 December 2022 411 176 14 601 Depreciation charge for the year 170 98 7 275 Impairment charge 14 – – 14 Disposals and other movements (53) (61) (2) (116) Exchange adjustments 7 2 – 9 At 31 December 2023 549 215 19 783 Net book value At 31 December 2021 807 167 14 988 At 31 December 2022 771 153 18 942 At 31 December 2023 803 280 17 1,100 7 Property, plant and equipment continued 170 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Lease liabilities 2023 2022 2021 $m $m $m The present value of lease liabilities is as follows: Within one year (271) (228) (233) Later than one year and not later than five years (657) (549) (544) Later than five years (200) (176) (210) Total lease liabilities (1,128) (953) (987) The interest expense on lease liabilities included within Finance expense was $33m (2022: $24m; 2021: $22m). The total cash outflow for leases in 2023 was $301m (2022: $268m; 2021: $262m). The Group has entered into lease contracts that have not yet commenced. The nominal value of estimated future lease payments under these lease contracts approximates $1,615m as of 31 December 2023. Of this value, $1,348m relates to a property lease in the US which is expected to commence in 2026 with a lease term of 15 years. In 2022 the Group entered into a sale and leaseback agreement in relation to the Waltham R&D site in MA, US. Prior to the sale, the carrying value of the Property, plant and equipment was $124m. Cash proceeds of $265m were received, recorded within Disposal of property, plant and equipment within the Consolidated Statement of Cash Flows, and a gain on disposal of $125m was recorded within Other operating income and expense within the Consolidated Statement of Comprehensive Income. A lease liability and a corresponding right-of-use asset were recorded of $28m and $13m, respectively. 9 Goodwill 2023 2022 2021 $m $m $m Cost At 1 January 20,131 20,311 12,164 Additions through business combinations (Note 27) 158 15 8,287 Exchange and other adjustments 72 (195) (140) At 31 December 20,361 20,131 20,311 Amortisation and impairment losses At 1 January 311 314 319 Exchange and other adjustments 2 (3) (5) At 31 December 313 311 314 Net book value At 31 December 20,048 19,820 19,997 Goodwill is tested for impairment at the operating segment level, this being the level at which goodwill is monitored for internal management purposes. As detailed in Note 6, the Group does not have multiple operating segments and is engaged in a single business activity of pharmaceuticals. Recoverable amount is determined on a fair value less costs to sell basis using the market value of the Company’s outstanding Ordinary Shares. Our market capitalisation is compared to the book value of the Group’s net assets and this indicates a significant surplus at 31 December 2023 (and 31 December 2022 and 31 December 2021). No goodwill impairment was identified. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 171 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 10 Intangible assets Product, Software marketing and Other development distribution rights intangibles costs Total $m $m $m $m Cost At 1 January 2021 42,677 2,642 1,288 46,607 Additions through business combinations (Note 27) 26,455 430 70 26,955 Additions – separately acquired 587 6 119 712 Transferred to Assets held for sale (Note 18) (1,266) (47) – (1,313) Disposals (801) (402) (23) (1,226) Exchange and other adjustments (1,062) (18) (22) (1,102) At 31 December 2021 66,590 2,611 1,432 70,633 Additions through business combinations (Note 27) – 46 – 46 Additions – separately acquired 2,051 12 105 2,168 Disposals (57) (105) (36) (198) Exchange and other adjustments (1,799) (122) (106) (2,027) At 31 December 2022 66,785 2,442 1,395 70,622 Additions through business combinations (Note 27) 65 35 – 100 Additions – separately acquired 2,530 200 170 2,900 Disposals (669) – (14) (683) Exchange and other adjustments 496 30 24 550 At 31 December 2023 69,207 2,707 1,575 73,489 Amortisation and impairment losses At 1 January 2021 22,564 2,128 968 25,660 Amortisation for year 2,908 172 63 3,143 Impairment charges 2,067 – 18 2,085 Transferred to Assets held for sale (Note 18) (931) (14) – (945) Disposals (797) (402) (21) (1,220) Exchange and other adjustments (535) (21) (26) (582) At 31 December 2021 25,276 1,863 1,002 28,141 Amortisation for year 3,899 181 76 4,156 Impairment charges 236 82 – 318 Impairment reversals (77) – (17) (94) Disposals (55) (105) (20) (180) Exchange and other adjustments (887) (76) (63) (1,026) At 31 December 2022 28,392 1,945 978 31,315 Amortisation for year 3,771 75 80 3,926 Impairment charges 434 – – 434 Disposals (667) – (12) (679) Exchange and other adjustments 336 41 27 404 At 31 December 2023 32,266 2,061 1,073 35,400 Net book value At 31 December 2021 41,314 748 430 42,492 At 31 December 2022 38,393 497 417 39,307 At 31 December 2023 36,941 646 502 38,089 2023 2022 2021 $m $m $m Net book value Current intangible assets – – 105 Non-current intangible assets 38,089 39,307 42,387 At 31 December 38,089 39,307 42,492 Other intangibles consist mainly of research and device technologies and the Alexion brand name. Included within Software development costs are assets currently in development that will commence amortisation when ready for use. Included within Additions − separately acquired are amounts of $625m (2022: $1,135m; 2021: $124m), relating to deferred payments and other non-cash consideration for the acquisition of Product, marketing and distribution rights, which are not reflected in the current year Consolidated Statement of Cash Flows. Disposals include amounts related to fully depreciated assets that are no longer in use by the Group. 172 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Amortisation charges are recognised in profit as follows: Product, Software marketing and Other development distribution rights intangibles costs Total $m $m $m $m Year ended 31 December 2021 Cost of sales 66 – – 66 Research and development expense – 33 – 33 Selling, general and administrative expense 2,842 138 63 3,043 Other operating income and expense – 1 – 1 Total 2,908 172 63 3,143 Year ended 31 December 2022 Cost of sales 32 – – 32 Research and development expense – 30 – 30 Selling, general and administrative expense 3,867 151 76 4,094 Total 3,899 181 76 4,156 Year ended 31 December 2023 Cost of sales 32 – – 32 Research and development expense – 28 – 28 Selling, general and administrative expense 3,739 47 80 3,866 Total 3,771 75 80 3,926 Net impairment charges are recognised in profit as follows: Product, Software marketing and Other development distribution rights intangibles costs Total $m $m $m $m Year ended 31 December 2021 Research and development expense 1,464 – – 1,464 Selling, general and administrative expense 603 – 18 621 Total 2,067 – 18 2,085 Year ended 31 December 2022 Research and development expense 95 – – 95 Selling, general and administrative expense 64 82 (17) 129 Total 159 82 (17) 224 Year ended 31 December 2023 Research and development expense 417 – – 417 Selling, general and administrative expense 17 – – 17 Total 434 – – 434 Impairment charges and reversals We perform a rigorous impairment trigger assessment for all our intangible assets. Intangible assets under development and not available for use are tested annually for impairment and other intangible assets are tested when there is an indication of impairment loss or reversal. Where testing is required, the recoverable amount of the assets is estimated in order to determine the extent of the impairment loss or reversal. Where it is not possible to estimate the recoverable amount of an individual asset, the Group estimates the recoverable amount of the Cash Generating Unit (CGU) to which it belongs. The Group considers that as the intangible assets are linked to individual products and that product cash flows are considered to be largely independent of other product cash flows, the CGU for intangibles is at the product level. Group-level budgets and forecasts include forecast capital investment and operational impacts related to sustainability projects, as well as inflationary impacts, and form the basis for the value in use models used for impairment testing. An asset’s recoverable amount is determined as the higher of an asset’s or CGU’s fair value less costs to sell or value in use, in both cases using discounted cash flow calculations where the asset’s expected post-tax cash flows are risk-adjusted over their estimated remaining period of expected economic benefit. Where the value in use approach is used, the post-tax risk-adjusted cash flows are discounted using AstraZeneca’s post-tax weighted average cost of capital (7.5% for 2023, 7% for 2022 and 2021) which is a nominal rate. There is no material difference in the approach taken to using pre-tax cash flows and a pre-tax rate compared to post-tax cash flows and a post-tax rate, as required by IAS 36. Where fair value less costs to sell is used to determine recoverable value, the discount rate is assessed with reference to a market participant; this is not usually materially different to the AstraZeneca post-tax weighted average cost of capital of 7.5%. Intangible assets have been tested for impairment under the value in use basis at risk-adjusted post-tax discount rates ranging between 7.5% to 9.5%. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 173 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 10 Intangible assets continued Key assumptions and significant estimates used in calculating the recoverable amounts are highly sensitive and specific to the nature of the Group’s activities including: > outcome of R&D activities > probability of technical and regulatory success > market volume, share and pricing (to derive peak year sales) > amount and timing of projected future cash flows > sales erosion curves following patent expiry. Whilst the intangible assets portfolio is generally exposed to significant impairment risk within the next financial year, no sensitivities have been disclosed since no specific asset has been identified as having a significant risk of a material impairment arising from reasonably possible changes in key assumptions. For assets held at fair value less costs to sell, we make appropriate adjustments to reflect market participant assessments. In 2023, the Group recorded impairment charges of $17m in respect of launched products. Impairment charges recorded against products in development totalled $417m, including $244m related to ALXN1840 which was fully impaired following the decision to discontinue development. In 2022, the Group recorded impairment charges of $146m in respect of launched products. Impairment charges recorded against products in development totalled $172m due to decisions made to terminate the related activities. In 2021, the Group recorded impairment charges of $603m in respect of launched products, including Bydureon ($469m, revised carrying amount of $50m) under value in use model, roxadustat ($121m, revised carrying amount of $215m) under value in use model and other launched products totalling $13m. Impairment charges recorded against products in development in 2021, based on fair value less costs to sell, totalled $1,464m, principally Ardea ($1,172m) which was fully impaired following the decision to discontinue development of verinurad. The remaining impairments relate to full impairments of various products in development, due to either management’s decision to discontinue development as part of a Group-wide portfolio prioritisation review, or due to the outcome of research activities. The Group has performed an assessment on assets which have had impairments recorded in previous periods to determine if any reversals of impairments were required. No impairment reversals were recorded in 2023. Impairment reversals of $94m were recorded in 2022, including $77m in respect of products in development. No impairment reversals were recorded in 2021. When launched products are partially impaired, the carrying values of these assets in future periods are particularly sensitive to changes in forecast assumptions, including those assumptions set out above, as the asset is impaired down to its recoverable amount. Significant assets Carrying value Remaining amortisation $m period C5 franchise (Soliris/Ultomiris) intangible assets arising from the acquisition of Alexion 14,356 4 to 12 years Intangible assets arising from the acquisition of Acerta Pharma 4,335 9 years Strensiq, Kanuma, Andexxa intangible assets arising from the acquisition of Alexion 4,147 9 to 15 years Enhertu intangible assets acquired from Daiichi Sankyo 2,831 10 years Intangible asset products in development arising from the acquisition of Alexion1 2,489 Not amortised Intangible assets arising from the acquisition of ZS Pharma Inc. 1,838 8 years Other intangible assets acquired from Daiichi Sankyo1 989 Not amortised Baxdrostat intangible asset acquired from CinCor Pharma, Inc.1 780 Not amortised Airsupra intangible asset 524 11 years Intangible assets arising from the restructuring of a historical joint venture with MSD 472 3 to 6 years Farxiga/Forxiga intangible assets acquired from BMS 426 3 years Intangible assets arising from the acquisition of Pearl Therapeutics, Inc 412 5 to 6 years Monalizumab intangible assets acquired from Innate Pharma1 370 Not amortised RSV franchise assets arising from the acquisition of MedImmune 305 2 years Rare disease portfolio assets acquired from Pfizer1 300 Not amortised 1 Assets in development are not amortised but are tested annually for impairment. The intangible asset baxdrostat recognised on acquisition of CinCor Pharma, Inc. in 2023 was assessed under the optional concentration test in IFRS 3 and was determined to be an asset acquisition, as substantially all of the value of the gross assets acquired was concentrated in this single asset. The acquisition of Pfizer’s pre-clinical rare disease gene therapy portfolio in 2023 was assessed under IFRS 3 and the transaction was treated as an asset acquisition. 174 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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11 Investments in associates and joint ventures 2023 2022 2021 $m $m $m At 1 January 76 69 39 Additions 80 26 92 Share of after tax losses (12) (5) (64) Exchange and other adjustments 3 (14) 2 At 31 December 147 76 69 On 1 November 2023, AstraZeneca entered into an agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet medical need, including oncology, immunology and rare diseases. Under the terms of the agreement, AstraZeneca contributed $80m in funds and holds a 22% interest in the associate entity. On 29 January 2021, AstraZeneca entered into an agreement with IHP Holdings Limited to create and run an online platform (iHospital) offering consultations with physicians, repeat prescriptions and e-pharmacy in China. The agreement resulted in the formation of a new entity, IHP HK 27 Holdings Limited. AstraZeneca contributed $30m in initial funds and holds a 50% interest in the associate entity. On 1 December 2020, AstraZeneca and China International Capital Corporation (CICC) entered into an agreement to set up a Global Healthcare Industrial Fund to drive healthcare system innovation by leveraging local capital and accelerating China-related innovation incubation. The agreement resulted in the formation of a new entity, Wuxi AstraZeneca-CICC Venture Capital Partnership (Limited Partnership). AstraZeneca holds a 22% interest in the associate entity and contributed $1m in initial funds in 2020, with contributions of $45m and $21m made in 2021 and 2022 respectively. On 23 September 2021, AstraZeneca entered into an agreement with VaxEquity Limited to collaborate and develop self-amplifying RNA technology with the aim of generating treatments for target diseases. AstraZeneca contributed $14m in initial funds and holds a 40% interest in the associate entity. On 23 February 2018, AstraZeneca entered into an agreement with a consortium of investors to form a new, US-domiciled standalone company called Viela Bio. In February 2021, AstraZeneca agreed to divest its 26.7% ownership in Viela Bio, as part of the acquisition of Viela by Horizon Therapeutics plc. AstraZeneca received cash proceeds and profit of $776m upon closing with the profit recorded as Other operating income. In 2021, prior to divestment, the Group provided transitional research and development services to Viela Bio, comprising $1m of passed-through third-party costs incurred by the Group on behalf of Viela Bio. On 27 November 2017, AstraZeneca entered into a joint venture agreement with Chinese Future Industry Investment Fund (FIIF), to discover, develop and commercialise potential new medicines to help address unmet medical needs globally, and to bring innovative new medicines to patients in China more quickly. The agreement resulted in the formation of a joint venture entity based in China, Dizal (Jiangsu) Pharmaceutical Co., Limited (Dizal). Since its establishment, AstraZeneca has contributed $80m in cash to the joint venture entity and has a 27% interest in the joint venture. On 1 December 2015, AstraZeneca entered into a joint venture agreement with Fujifilm Kyowa Kirin Biologics Co., Ltd. to develop a biosimilar using the combined capabilities of the two parties. The agreement resulted in the formation of a joint venture entity based in the UK, Centus Biotherapeutics Limited (Centus). Since its establishment, AstraZeneca has contributed $135m in cash to the joint venture entity and has a 50% interest in the joint venture. On 26 April 2023, Centus entered a voluntary liquidation process. All investments are accounted for using the equity method. At 31 December 2023, unrecognised losses in associates and joint ventures totalled $140m (2022: $92m; 2021: $73m) which have not been recognised due to the investment carrying value reaching $nil value. Aggregated summarised financial information for the associate and joint venture entities is set out below: 2023 2022 2021 $m $m $m Non-current assets 424 290 215 Current assets 362 300 506 Total liabilities (287) (72) (99) Net assets 499 518 622 Amount attributable to AstraZeneca 85 91 65 Goodwill 52 – – Exchange adjustments 10 (15) 4 Carrying value of investments in associates and joint ventures 147 76 69 Joint contractual arrangements were entered into between AstraZeneca and Daiichi Sankyo Company Limited (Daiichi Sankyo); in March 2019 for the co-development and co-commercialisation of Enhertu and in July 2020 for the co-development and co-commercialisation of Dato-DXd. Each party shares global pre-tax net income from the collaboration on a 50:50 basis (with the exception of Japan where Daiichi Sankyo maintains exclusive rights and AstraZeneca receives a royalty). The joint operation is not structured through a separate legal entity, and it operates from AstraZeneca and Daiichi Sankyo’s respective principal places of business. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 175 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 12 Other investments 2023 2022 2021 $m $m $m Non-current investments Equity securities at fair value through Other comprehensive income 1,530 1,056 1,168 Fixed income securities at fair value through profit or loss – 10 – Total 1,530 1,066 1,168 Current investments Fixed income securities at fair value through profit or loss 20 13 16 Cash collateral pledged to counterparties 102 162 – Fixed deposits – 64 53 Total 122 239 69 Other investments held at FVOCI include equity securities which are not held for trading and which the Group has irrevocably elected at initial recognition to recognise in this category. Other investments held at FVPL mainly comprise fixed income securities that the Group holds to sell. The fair value of listed investments is based on year end quoted market prices. Fixed deposits and Cash collateral pledged to counterparties are held at amortised cost with carrying value being a reasonable approximation of fair value given their short-term nature. Cash collateral pledged to counterparties relates to collateral pledged on derivatives entered into to hedge the Group’s risk exposures. In 2022, following significant foreign currency volatility increasing the collateral requirements, the Group revised its presentation to ‘Other investments’. In 2021 amounts of $47m are presented within Cash and cash equivalents. Fair value hierarchy The table below analyses equity securities and bonds, contained within Other investments and carried at fair value, by valuation method. The different levels have been defined as follows: > Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities > Level 2: inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (i.e. as prices) or indirectly (i.e. derived from prices) > Level 3: inputs for the asset or liability that are not based on observable market data (unobservable inputs). 2023 2023 2022 2022 2021 2021 FVPL FVOCI FVPL FVOCI FVPL FVOCI $m $m $m $m $m $m Level 1 20 1,217 13 880 16 1,064 Level 2 – – – – – – Level 3 – 313 10 176 – 104 Total 20 1,530 23 1,056 16 1,168 Assets are transferred in or out of each Level on the date of the event or change in circumstances that caused the transfer. Equity securities that are analysed at Level 3 include investments in private biotech companies. In the absence of specific market data, these unlisted investments are held at fair value based on the cost of investment and adjusting as necessary for impairments and revaluations on new funding rounds, which approximates to fair value. Movements in Level 3 investments are detailed below: 2023 2023 2022 2022 2021 FVPL FVOCI FVPL FVOCI FVOCI $m $m $m $m $m At 1 January 10 176 – 104 217 Additions – 127 10 32 1 Revaluations 3 14 – 50 – Net transfers out from Level 3 to Level 1 – – – (4) (113) Disposals (13) (8) – (5) – Impairments and exchange adjustments – 4 – (1) (1) At 31 December – 313 10 176 104 176 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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13 Derivative financial instruments Non-current Current Current Non-current assets assets liabilities liabilities Total $m $m $m $m $m Interest rate swaps related to instruments designated at fair value through profit or loss1 25 – – – 25 Cross currency swaps designated in a net investment hedge 62 – – (2) 60 Cross currency swaps designated in a cash flow hedge – – – (43) (43) Forward FX designated in a cash flow hedge2 – 13 – – 13 Other derivatives 15 70 (79) – 6 31 December 2021 102 83 (79) (45) 61 Non-current Current Current Non-current assets assets liabilities liabilities Total $m $m $m $m $m Interest rate swaps related to instruments designated at fair value through profit or loss1 – 1 – – 1 Cross currency swaps designated in a net investment hedge 55 – – (4) 51 Cross currency swaps designated in a cash flow hedge – – – (160) (160) Forward FX designated in a cash flow hedge2 – 1 (13) – (12) Other derivatives 19 85 (80) – 24 31 December 2022 74 87 (93) (164) (96) Non-current Current Current Non-current assets assets liabilities liabilities Total $m $m $m $m $m Cross currency swaps designated in a net investment hedge 100 – – (1) 99 Cross currency swaps designated in a cash flow hedge 116 – (30) (37) 49 Forward FX designated in a cash flow hedge2 – 19 (4) – 15 Other derivatives 12 97 (122) – (13) 31 December 2023 228 116 (156) (38) 150 1 Interest rate swaps related to instruments designated at fair value through profit or loss matured in 2023. 2 Forward FX designated in a cash flow hedge relates to contracts hedging anticipated CNY, EUR, GBP, JPY and SEK transactions occurring in the quarter immediately after the balance sheet date. All derivatives are held at fair value and fall within Level 2 of the fair value hierarchy as defined in Note 12, except for an equity warrant which falls within Level 3 (valued at $12m (2022: $19m; 2021: $15m), held within Non-current assets). None of the derivatives have been reclassified in the year. The fair value of interest rate swaps and cross currency swaps is estimated using appropriate zero coupon curve valuation techniques to discount future contractual cash flows based on rates at the current year end. The fair value of forward foreign exchange contracts and currency options are estimated by cash flow accounting models using appropriate yield curves based on market forward foreign exchange rates at the year end. The majority of forward foreign exchange contracts for existing transactions had maturities of less than one month from year end. The interest rates used to discount future cash flows for fair value adjustments, where applicable, are based on market swap curves at the reporting date, and were as follows: 2023 2022 2021 Derivatives 0.1% to 5.3% 0.1% to 4.7% (0.5)% to 3.6% 14 Non-current other receivables 2023 2022 2021 $m $m $m Prepayments 274 243 391 Accrued income 52 44 61 Retirement benefit scheme surpluses (Note 22) 92 90 – Other receivables 385 458 443 Non-current other receivables 803 835 895 Prepayments include $nil (2022: $nil; 2021: $92m) in relation to our research collaboration with Moderna. Other receivables include $51m (2022: $71m; 2021: $44m) owed by FibroGen, Inc. for promotional activity in China pursuant to the roxadustat collaboration. 15 Inventories 2023 2022 2021 $m $m $m Raw materials and consumables 1,531 1,422 1,755 Inventories in process 2,325 1,864 5,216 Finished goods and goods for resale 1,568 1,413 2,012 Inventories 5,424 4,699 8,983 The Group recognised $6,038m (2022: $9,618m; 2021: $9,640m) of inventories as an expense within Cost of sales during the year. Inventory write-downs in the year amounted to $574m (2022: $479m; 2021: $552m), principally arising from the reassessment of usage or demand expectations prior to inventory expiration. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 177 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 16 Current trade and other receivables 2023 2022 2021 $m $m $m Trade receivables 8,452 7,271 6,054 Less: Expected credit loss provision (Note 28) (45) (59) (23) 8,407 7,212 6,031 Other receivables 1,639 1,659 1,808 Prepayments 1,617 1,329 1,512 Government grants receivable 11 25 – Accrued income 452 296 293 Trade and other receivables 12,126 10,521 9,644 Trade receivables include $1,977m (2022: $2,470m; 2021: $1,865m) measured at FVOCI classified ‘hold to collect and sell’ as they are due from customers that the Group has the option to factor, or relate to bank acceptance drafts received in settlement of trade receivables per common practice in China. All other financial assets included within Current trade and other receivables are held at amortised cost with carrying value being a reasonable approximation of fair value. 17 Cash and cash equivalents 2023 2022 2021 $m $m $m Cash at bank and in hand 1,325 1,411 1,461 Short-term deposits 4,515 4,755 4,868 Cash and cash equivalents 5,840 6,166 6,329 Unsecured bank overdrafts (203) (183) (291) Cash and cash equivalents in the cash flow statement 5,637 5,983 6,038 AstraZeneca invests in constant net asset value funds, low-volatility net asset value funds and short-term variable net asset value funds with same day access for subscription and redemption. These investments fail the ‘solely payments of principal and interest’ test criteria under IFRS 9. They are therefore measured at FVPL, although the fair value is materially the same as amortised cost. Non-cash and other movements, within operating activities in the Consolidated Statement of Cash Flows, includes: 2023 2022 2021 $m $m $m Share-based payments charge for the period 579 619 615 Settlement of share plan awards (650) (592) (570) Pension contributions (188) (205) (174) Pension charges recorded in operating profit 55 101 136 Long-term provision charges recorded in operating profit 460 87 270 (Gain)/loss on disposal of tangible assets (41) (112) 4 Update to the contractual relationships for Beyfortus (nirsevimab) (729) – – Foreign exchange and other1 128 (590) (186) Total operating activities non-cash and other movements (386) (692) 95 1 Foreign exchange and other includes, among other items, the foreign exchange of inter-company transactions, including dividends, across Group entities and the related impact from hedging those transactions. 18 Assets held for sale Assets held for sale amount to $nil (2022: $150m; 2021: $368m). In 2022, Assets held for sale comprised Property, plant and equipment assets relating to the West Chester site in Ohio, US. The transaction closed on 30 January 2023. In 2021, Assets held for sale comprised Intangible assets relating to the rights to certain respiratory assets acquired from Almirall and Actavis plc. (including Tudorza and Duaklir). The transaction closed on 4 January 2022. 178 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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19 Interest-bearing loans and borrowings Repayment 2023 2022 2021 dates $m $m $m Current liabilities Bank overdrafts On demand 203 183 291 Other short-term borrowings excluding overdrafts 97 78 3 Collateral received from derivative counterparties 215 89 93 Lease liabilities 271 228 233 Floating rate notes US dollars 2022 – – 250 2.375% Callable bond US dollars 2022 – – 999 0.3% Callable bond US dollars 2023 – 1,399 – 2023 Floating bank loan US dollars 2023 – 2,000 – Floating rate notes US dollars 2023 – 400 – 3.5% Callable bond US dollars 2023 – 849 – 7% Guaranteed debentures US dollars 2023 – 294 – 0.75% Callable bond euros 2024 995 – – 0.7% Callable bond US dollars 2024 1,600 – – 2024 Floating rate bank loans US dollars 2024 2,000 – – Other loans (including commercial paper) Within one year 19 22 24 Total 5,400 5,542 1,893 Non-current liabilities Lease liabilities 857 725 754 0.3% Callable bond US dollars 2023 – – 1,397 2023 Floating bank loan US dollars 2023 – – 1,998 Floating rate notes US dollars 2023 – – 400 3.5% Callable bond US dollars 2023 – – 848 7% Guaranteed debentures US dollars 2023 – – 320 0.75% Callable bond euros 2024 – 957 1,014 0.7% Callable bond US dollars 2024 – 1,598 1,598 2024 Floating bank loans US dollars 2024 – 1,998 1,997 3.375% Callable bond US dollars 2025 1,994 1,992 1,988 0.7% Callable bond US dollars 2026 1,196 1,195 1,193 1.2% Callable bond US dollars 2026 1,248 1,246 1,245 3.625% Callable bond euros 2027 829 – – 3.125% Callable bond US dollars 2027 747 746 745 4.875% Callable bond US dollars 2028 1,095 – – 1.25% Callable bond euros 2028 879 845 896 1.75% Callable bond US dollars 2028 1,246 1,245 1,244 4% Callable bond US dollars 2029 995 995 994 0.375% Callable bond euros 2029 881 846 898 4.9% Callable bond US dollars 2030 645 – – 1.375% Callable bond US dollars 2030 1,294 1,293 1,292 2.25% Callable bond US dollars 2031 747 747 746 5.75% Non-callable bond pound sterling 2031 444 420 470 3.75% Callable bond euros 2032 827 – – 4.875% Callable bond US dollars 2033 497 – – 6.45% Callable bond US dollars 2037 2,725 2,724 2,724 4% Callable bond US dollars 2042 989 988 988 4.375% Callable bond US dollars 2045 981 981 980 4.375% Callable bond US dollars 2048 738 737 737 2.125% Callable bond US dollars 2050 487 487 486 3% Callable bond US dollars 2051 735 735 734 Other loans US dollars 146 190 202 Total 23,222 23,690 28,888 Total interest-bearing loans and borrowings1, 2 28,622 29,232 30,781 1 All loans and borrowings above are unsecured. In previous years, there were current (2022: $22m; 2021: $24m) and non-current (2022: $181m; 2021: $188m) secured loans, both included within Other loans. 2 The $2bn USD 2024 floating rate bank loans pay interest rate based on compounded daily USD Secured Overnight Funding Rate (SOFR). Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 179 Strategic Report Corporate Governance Financial Statements Additional Information |
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19 Interest-bearing loans and borrowings continued Notes to the Group Financial Statements continued Total Total Total loans and loans and loans and borrowings borrowings borrowings 2023 2022 2021 $m $m $m At 1 January 29,232 30,781 20,380 Changes from financing cash flows Issue of loans and borrowings 3,816 – 12,929 Repayment of loans and borrowings (4,942) (1,271) (4,759) Movement in short-term borrowings 161 74 (276) Repayment of obligations under leases (268) (244) (240) Total changes in cash flows arising on financing activities from borrowings (1,233) (1,441) 7,654 Movement in overdrafts 20 (85) 31 New lease liabilities 444 253 503 Additions through business combinations – 5 2,523 Exchange 187 (287) (378) Other movements (28) 6 68 At 31 December 28,622 29,232 30,781 Also included within cash flows arising from financing activities within the Consolidated Statement of Cash Flows is a $867m cash outflow (2022: outflow of $920m; 2021: $nil) related to the Acerta Pharma share purchase liability which has a closing liability at 31 December 2023 of $833m (2022: $1,646m; 2021: $2,458m) within Trade and other payables (see Note 20). Set out below is a comparison by category of carrying values and fair values of all the Group’s interest-bearing loans and borrowings: Instruments Instruments Total designated designated in Amortised carrying Fair at fair value1 cash flow hedge2 cost value value $m $m $m $m $m 2021 Overdrafts – – 291 291 291 Lease liabilities due within one year – – 233 233 233 Lease liabilities due after more than one year – – 754 754 754 Loans and borrowings due within one year – – 1,369 1,369 1,378 Loans and borrowings due after more than one year 320 1,910 25,904 28,134 30,596 Total at 31 December 2021 320 1,910 28,551 30,781 33,252 2022 Overdrafts – – 183 183 183 Lease liabilities due within one year – – 228 228 228 Lease liabilities due after more than one year – – 725 725 725 Loans and borrowings due within one year 294 – 4,837 5,131 5,105 Loans and borrowings due after more than one year – 1,802 21,163 22,965 21,657 Total at 31 December 2022 294 1,802 27,136 29,232 27,898 2023 Overdrafts – – 203 203 203 Lease liabilities due within one year – – 271 271 271 Lease liabilities due after more than one year – – 857 857 857 Loans and borrowings due within one year – 995 3,931 4,926 4,887 Loans and borrowings due after more than one year – 2,535 19,830 22,365 21,769 Total at 31 December 2023 – 3,530 25,092 28,622 27,987 1 Instruments designated at FVPL include the US dollar 7% guaranteed debentures which matured on 15 November 2023. 2 Instruments designated in cash flow hedges are our euro 500m 0.25% Callable bond which matured in 2021, our euro 900m 0.75% 2024 Callable bond, our euro 750m 3.625% 2027 Callable bond, our euro 800m 1.25% 2028 Callable bond, and our euro 750m 3.75% 2032 Callable bond. The fair value of fixed-rate publicly traded debt is based on year end quoted market prices; the fair value of floating rate debt is nominal value, as mark-to-market differences would be minimal given the frequency of resets. The carrying value of loans designated at FVPL is the fair value; this falls within the Level 1 valuation method as defined in Note 12. For loans designated in a fair value hedge relationship, carrying value is initially measured at fair value and remeasured for fair value changes in respect of the hedged risk at each reporting date. All other loans are held at amortised cost. Fair values, as disclosed in the table above, are all determined using the Level 1 valuation method as defined in Note 12, with the exception of overdrafts and lease liabilities, where fair value approximates to carrying values. 180 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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A loss of $6m was made during the year on the fair value of bonds designated as FVPL. A gain of $25m has been made on these bonds since designation. Under IFRS 9, the Group records the component of fair value changes relating to the component of own credit risk through Other comprehensive income. Changes in credit risk had no material effect on any other financial assets and liabilities recognised at fair value in the Group Financial Statements. The change in fair value attributable to changes in credit risk is calculated as the change in fair value not attributable to market risk. The interest rates used to discount future cash flows for fair value adjustments, where applicable, are based on market swap curves at the reporting date, and were as follows: 2023 2022 2021 Loans and borrowings n/a to n/a1 4.3% to 4.9% 0.1% to 0.6% 1 All bonds designated as FVPL have matured prior to the reporting date. 20 Trade and other payables 2023 2022 2021 $m $m $m Current liabilities Trade payables 3,267 2,550 2,824 Value-added and payroll taxes and social security 492 468 463 Rebates, chargebacks, returns and other revenue accruals 7,817 6,078 5,298 Clinical trial accruals 1,424 1,417 1,047 Other accruals 6,112 5,551 5,649 Collaboration Revenue contract liabilities 7 12 12 Vaccine contract liabilities 142 169 1,003 Deferred government grant income – 1 67 Contingent consideration 966 757 849 Acerta Pharma share purchase liability (Note 26) 833 867 920 Other payables 1,314 1,170 806 Total 22,374 19,040 18,938 Non-current liabilities Accruals 36 37 25 Collaboration Revenue contract liabilities 7 14 26 Contingent consideration 1,171 1,465 2,016 Acerta Pharma share purchase liability (Note 26) – 779 1,538 Other payables 1,446 1,975 1,328 Total 2,660 4,270 4,933 Included within Rebates, chargebacks, returns and other revenue accruals are contract liabilities of $102m (2022: $87m; 2021: $99m). The revenue recognised in the year from opening contract liabilities is $88m, comprising $76m relating to other revenue accruals and $12m Collaboration Revenue contract liabilities. The major markets with Rebates, chargebacks, returns and other revenue accruals are the US where the liability at 31 December 2023 amounted to $5,116m (2022: $3,961m; 2021: $3,172m), of which Rare Disease comprises $190m (2022: $139m; 2021: $127m), and China where the liability at 31 December 2023 amounted to $567m (2022: $579m; 2021: $814m). Trade payables includes $123m (2022: $67m; 2021: $44m) due to suppliers that have signed up to a supply chain financing programme, under which the suppliers can elect on an invoice-by-invoice basis to receive a discounted early payment from the relationship bank rather than being paid in line with the agreed payment terms. If the option is taken, the Group’s liability is assigned by the supplier to be due to the relationship bank rather than the supplier. The value of the liability payable by the Group remains unchanged. The Group assesses the arrangement against indicators to assess if debts which vendors have sold to the funder under the supplier financing scheme continue to meet the definition of trade payables or should be classified as borrowings. At 31 December 2023, the payables met the criteria of Trade payables. The supply chain financing programme operates in the US, UK, Sweden, China and Germany, and as at 31 December 2023, the programme had 461 suppliers enrolled across these countries. Vaccine contract liabilities relate to amounts received from customers, primarily government bodies, in advance of supply of product. Deferred government grant income relates to government grants received or receivable but for which the related expenses have not been incurred. Included within current Other payables are liabilities to Daiichi Sankyo totalling $199m (2022: $100m; 2021: $nil) resulting from the collaboration agreement in relation to Enhertu entered into in March 2019 and $nil (2022: $nil; 2021: $324m) in relation to Dato-DXd entered into in July 2020. Additionally, included within non-current Other payables are liabilities totalling $774m (2022: $1,125m; 2021: $100m) as a result of the Enhertu collaboration agreement and $464m (2022: $nil; 2021: $nil) as a result of the Airsupra collaboration agreement. In November 2020, Calquence received marketing approval in the EU, which removed all remaining conditionality in respect of the Acerta Pharma put and call options regarding the non-controlling interest; the option was exercised in April 2021 (see Note 26). The payments will be made in similar annual instalments in 2022 through to 2024, with the first payment of $920m made in 2022 and the second payment of $867m made in 2023, with a closing liability as at 31 December 2023 of $833m (2022: $1,646m; 2021: $2,458m). Interest arising from amortising the liability is included within Finance expense (see Note 3). The associated cash flows are disclosed as financing activities within the Consolidated Statement of Cash Flows. With the exception of Contingent consideration payables of $2,137m (2022: $2,222m; 2021: $2,865m) which are held at fair value within Level 3 of the fair value hierarchy as defined in Note 12, all other financial liabilities are held at amortised cost with carrying value being a reasonable approximation of fair value. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 181 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 20 Trade and other payables continued Contingent consideration 2023 2022 2021 $m $m $m At 1 January 2,222 2,865 3,323 Additions through business combinations 60 – – Settlements (826) (772) (643) Disposals – (121) – Revaluations 549 82 14 Reclassification to Other payables – – (55) Discount unwind (Note 3) 132 168 226 At 31 December 2,137 2,222 2,865 Contingent consideration arising from business combinations is fair valued using decision-tree analysis, with key inputs including the probability of success, consideration of potential delays and the expected levels of future revenues. Revaluations of Contingent consideration are recognised in Selling, general and administrative expense and include an increase of $520m in 2023 (2022: an increase of $182m; 2021: an increase of $42m) based on revised milestone probabilities, and revenue and royalty forecasts, relating to the acquisition of BMS’s share of the Global Diabetes Alliance. Discount unwind on the liability is included within Finance expense (see Note 3). The discount rate used for the Contingent consideration balances range from 5% to 8%. The most significant Contingent consideration balance is the Global Diabetes Alliance which is discounted at 8% and is reviewed against comparable benchmarks on a regular basis. Management has identified that reasonably possible changes in certain key assumptions, including the likelihood of achieving successful trial results, obtaining regulatory approval, the projected market share of the therapy area and expected pricing for launched products, may cause the calculated fair value of the above contingent consideration to vary materially in future years. The contingent consideration balance relating to BMS’s share of Global Diabetes Alliance of $1,945m (2022: $2,124m; 2021: $2,544m) would increase/ decrease by $195m with an increase/decrease in sales of 10% as compared with the current estimates. The maximum development and sales milestones payable under outstanding Contingent consideration arrangements arising on business combinations are as follows: Nature of Maximum future milestones Acquisitions Year contingent consideration $m Spirogen 2013 Milestones 180 Amplimmune, Inc. 2013 Milestones 150 Almirall1 2014 Milestones and royalties 345 Neogene 2023 Milestones 110 1 These contingent consideration liabilities have been designated as the hedge instrument in a net investment hedge of foreign currency risk arising on the Group’s underlying US dollar net investments held in non-US dollar denominated subsidiaries. Exchange differences on the retranslation of the contingent consideration liability are recognised in Other comprehensive income to the extent that the hedge is effective. Any ineffectiveness is taken to profit. The amount of royalties payable under the arrangements is inherently uncertain and difficult to predict, given the direct link to future sales and the range of outcomes. The maximum amount of royalties payable in each year is with reference to net sales. 21 Provisions Employee Other Severance Environmental benefits Legal provisions Total $m $m $m $m $m $m At 1 January 2021 214 100 128 348 770 1,560 Additions through business combinations (Note 27) – – 41 73 27 141 Charge for year 238 23 46 109 456 872 Cash paid (172) (32) (49) (285) (84) (622) Reversals (62) – – (5) (175) (242) Exchange and other movements (6) (1) 29 (1) (6) 15 At 31 December 2021 212 90 195 239 988 1,724 Charge for year 227 61 1 830 365 1,484 Cash paid (223) (19) (41) (814) (185) (1,282) Reversals (43) – (27) (94) (98) (262) Exchange and other movements (8) (1) 15 – (52) (46) At 31 December 2022 165 131 143 161 1,018 1,618 Charge for year 123 21 22 1,102 245 1,513 Cash paid (87) (41) (14) (219) (404) (765) Reversals (28) (3) (3) (23) (143) (200) Exchange and other movements 3 4 20 (5) (33) (11) At 31 December 2023 176 112 168 1,016 683 2,155 182 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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2023 2022 2021 $m $m $m Due within one year 1,028 722 768 Due after more than one year 1,127 896 956 Total 2,155 1,618 1,724 Provisions are often subject to substantial uncertainties with regard to the timing and final amounts of any payments. Once established, these amounts remain in Provisions even after settlement is reached and uncertainty resolved, with no transfer to Trade and other payables prior to payment. This is to provide more transparent disclosure of subsequent movements in brought forward and carried forward balances. Settled legal claims included within provisions are held at amortised cost with carrying value being a reasonable approximation of fair value. Severance provisions arise predominantly in connection with global restructuring initiatives, including the PAAGR, which involve rationalisation of the global supply chain, the sales and marketing organisation, IT and business support infrastructure, and R&D. In conjunction with the acquisition of Alexion in 2021, the enlarged Group initiated the PAAGR; a global restructuring programme, aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments. This includes the commencement of work on the planned upgrade of the Group’s Enterprise Resource Planning IT systems (Axial Project). The Group has also continued to progress other legacy restructuring programmes. Employee costs in connection with the initiatives are recognised in severance provisions when a detailed formal plan has been communicated to those employees affected. Final severance costs are often subject to the completion of the requisite consultations on the areas impacted, with the majority of the cost expected to be paid within one year. AstraZeneca endeavours to support employees affected by restructuring initiatives to seek alternative roles within the organisation. Where the employee is successful, any severance provisions will be released. Details of the Environmental provisions totalling $112m (2022: $131m; 2021: $90m) and ongoing matters are provided in Note 30. These uncertainties can also cause reversal in previously established provisions once final settlement is reached. Legal issues are often subject to substantial uncertainties with regard to the timing and final amounts of any payments. A significant proportion of the total legal provision, $616m (2022: $30m; 2021: $15m) due within one year and $372m (2022: $92m; 2021: $105m) due after more than one year1 , relates to matters settled, but not paid, in previous periods, further details are provided in Note 30. The majority of Employee benefit provisions relate to Executive Deferred Compensation Plans, which include uncertainty over the ultimate timing and amount of payment to be made to the executives. Other provisions comprise amounts relating to specific contractual or constructive obligations and disputes. Included within Other provisions are amounts associated with long-standing product liability settlements that arose prior to the merger of Astra and Zeneca, which given the nature of the provision, the amounts are expected to be settled over many years; the final settlement values and timings are uncertain. Also included in Other provisions is an amount of $163m (2022: $165m; 2021: $185m), in relation to third-party liability and other risks (including incurred but not yet reported claims); the claims are considered to be uncertain as to timing and amount. Charges to Other provisions in 2023 included $87m (2022: $12m; 2021: $243m) in relation to the PAAGR restructuring programme, which has a closing provision of $49m (2022: $143m; 2021: $243m), including $8m (2022: $95m; 2021: $158m) held in non-current provisions expected to be settled over time by 2025. In 2022, charges to Other provisions included $301m in relation to termination fees and onerous contracts with contract manufacturing organisations, the vast majority of which was settled in 2023. No provision has been released or applied for any purpose other than that for which it was established. 22 Post-retirement pension and other defined benefit schemes Background This section predominantly covers defined benefit arrangements like post-retirement pension and medical plans which make up the vast bulk of the Group’s liabilities. However, it also incorporates other benefits which fall under IAS 19 rules and which require an actuarial valuation, including but not limited to: lump sum plans, long service awards and defined contribution pension plans which have some defined benefit characteristics (e.g. a minimum guaranteed level of benefit). In total, over 50 plans in 28 countries are covered. The Group and most of its subsidiaries offer retirement plans which cover the majority of employees. The Group’s policy is to provide defined contribution (DC) orientated pension provision to its employees unless otherwise compelled by local regulation. As a result, many of these retirement plans are DC, where the Group contribution and resulting charge is fixed at a set level or is a set percentage of employees’ pay. However, several plans, mainly in the UK and Sweden, are defined benefit (DB), where benefits are based on employees’ length of service and salary. The major DB plans are largely legacy arrangements as they have been closed to new entrants since 2000, apart from the collectively bargained Swedish plan (which is still open to employees born before 1979). During 2010, following consultation with its UK employees’ representatives, the Group introduced a freeze on pensionable pay at 30 June 2010 levels for DB members of the UK Pension Fund. The number of active members in the Fund continues to decline and is now 400 employees. The major DB plans are funded through separate, fiduciary-administered assets. The cash funding of the plans, which may from time to time involve payments from the Group, is designed, in consultation with independent qualified actuaries, to ensure that the assets are sufficient to meet future obligations as and when they fall due. The funding level is monitored by the Group and local fiduciaries, who take into account the strength of the Group’s covenant, local regulation, cash flows, and the solvency and maturity of the pension plan. 1 The profile of future payments of legal provisions due after one year is as follows; in one to two years $180m (2022: $22m; 2021: $14m), in two to three years $159m (2022: $21m; 2021: $17m), in three to four years $10m (2022: $9m; 2021: $22m), in four to five years $9m (2022: $9m; 2021: $9m), and in more than five years $14m (2022: $31m; 2021: $43m). Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 183 Strategic Report Corporate Governance Financial Statements Additional Information |
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22 Post-retirement and other defined benefit schemes continued Notes to the Group Financial Statements continued Financing Principles and Funding Framework Eighty six per cent of the Group’s total DB obligations (or 66% of net obligations) at 31 December 2023 are in schemes within the UK and Sweden. In these countries, the pension obligations are funded in line with the Group’s financing principles, as disclosed in prior years. The Group has developed a long-term funding framework to implement these principles. This framework targets either full funding on a low-risk funding measure, or buyout with an external insurer as the pension funds mature, with affordable long-term de-risking of investment strategy along the way. Unless local regulation dictates otherwise, this framework determines the cash contributions payable. UK The UK Pension Fund represents approximately 65% of the Group’s DB obligations at 31 December 2023. The financing principles are modified in light of the UK regulatory requirements (summarised below) and resulting discussions with the Trustee. Role of Trustee and Regulation The UK Pension Fund is governed and administered by a corporate Trustee which is legally separate from the Group. The Trustee Directors are comprised of representatives appointed by both the employer and employees and include an independent professional Trustee Director. The Trustee Directors are required by law to act in the interest of all relevant beneficiaries and are responsible in particular for investment strategy and the day-to-day administration of the benefits. They are also responsible for jointly agreeing with the employer the level of contributions due to the UK Pension Fund. The UK pensions industry is regulated by The Pensions Regulator whose statutory objectives and regulatory powers are described on its website, www.thepensionsregulator.gov.uk. The Pension Scheme Act 2021 became effective in the UK from 1 October 2021. A section of this Act places additional legal requirements on companies who sponsor UK defined benefit pension schemes, to monitor and assess corporate activity, with a focus on the potential impact of such activity on the ongoing security of these benefits. The Group maintains a framework to ensure it meets its responsibilities under the Act. There have been two UK High Court Rulings relating to Guaranteed Minimum Pensions (GMP) equalisation in 2018 and 2020. Following the publication of guidance around implementation in 2021, the Trustee, with input from the Group, has now completed the equalisation of benefits for the vast majority of pensioner members, with the project expected to complete in 2024. Further details are set out later in this Note. An estimate of the impact of these changes has already been recognised in 2018 and 2020, and actual experience is in line with the estimates previously recognised. In June 2023, the UK High Court (Virgin Media Limited v NTL Pension Trustees II Limited) ruled that certain historical amendments for contracted-out defined benefit schemes were invalid if they were not accompanied by the correct actuarial confirmation. The judgment is subject to appeal. The Trustee and Group are monitoring developments and will consider if there are any implications for the UK Pension Fund, if the ruling is upheld. Funding requirements UK legislation requires that an actuarial valuation is completed for all DB pension schemes every three years, which compares the schemes’ liabilities to its assets. As part of the triennial valuation process, the Trustee and the Group must agree on a set of assumptions to value the liabilities and determine the contributions required, if any, to ensure the UK Pension Fund is fully funded over an appropriate time period and on a suitably prudent measure. The assumptions used to value the liabilities for the triennial actuarial valuation are required to be prudent, whereas the assumptions used to prepare an IAS 19 accounting valuation are required to be ‘best estimate’. The last full actuarial valuation of the UK Pension Fund was carried out by a qualified actuary as at 31 March 2022 and finalised in May 2023, ahead of the statutory deadline. Under the funding assumptions used to set the statutory funding target, the key assumptions from the actuarial valuation as at 31 March 2022 (shown as a single-equivalent rate) were as follows: salary increases at 0% per annum (as a result of pensionable pay levels being frozen in 2010); pension increases at 3.64% per annum; and discount rate at 3.03% per annum. The resulting valuation of the Fund’s liabilities on that basis was £5,951m ($7,820m) compared to a market valuation of assets at 31 March 2022 of £5,604m ($7,364m). Aspects of the triennial actuarial valuation are governed by a long-term funding agreement, effective since October 2016, which sets out a path to full funding on a low-risk measure. Under this agreement, if a deficit exists, the Group is required to provide security. This security takes the form of a charge in favour of the Trustee over all land and buildings on the Group’s Cambridge Biomedical Campus site. This charge was enacted in December 2023, and provides long-term security to the Trustee in respect of the Group’s future deficit recovery contributions. The value of the charge is currently £317m ($404m) and it is capped at £350m ($446m). The value of the charge will vary and is expected to reduce over time, before falling away. Under the terms of the charge, the Trustee can only exercise its right over the ownership of the site in a Group insolvency event. 184 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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In relation to deficit recovery contributions, a lump sum contribution of £39m ($48m) was made in March 2023, with a further annual contribution of £39m ($50m) due before 31 March 2024, and each year up to March 2028. Further progress was made over 2023 in equalising GMP for members of the UK Pension Fund. The method of equalisation converts GMP to non-GMP pension to simplify the structure and administration of benefits. As at 31 December 2023, almost all pensioner and dependent members have had their benefits equalised and, for non-pensioner members, a process will be in place in 2024 to equalise their benefits at their point of retirement. As part of the project, a Pension Increase Exchange (‘PiE’) option was also made available to the majority of pensioner members, at the Group’s discretion. This option provided the member with a choice to opt for a higher pension right away, but with no, or fewer, inflation-linked increases in the future. Take-up of this option resulted in a reduction to expected future liabilities and a $16m past service credit was taken to the income statement in March 2023. Under the governing documentation of the UK Pension Fund, any future surplus in the Fund would be returnable to the Group by refund assuming gradual settlement of the liabilities over the lifetime of the Fund. In particular, the Trustee has no unilateral right to wind up the Fund without Company consent nor does it have the power to unilaterally use surplus to augment benefits prior to wind-up. As such, there are no adjustments required in respect of IFRIC 14 ‘IAS 19 – The Limit on a Defined Benefit Asset, Minimum Funding Requirements and their Interaction’. On current bases, it is expected that ongoing contributions (excluding those in respect of past service deficit contributions) during the year ending 31 December 2024 for the UK scheme will be approximately $18m. United States In May 2023, AstraZeneca Pharmaceuticals LP agreed a buy-out of its qualified US Defined Benefit Pension Plan with an external insurer. All Plan liabilities (approximately $840m) have now been discharged (via a mix of cash payments to participants and purchase of insured annuities), with an impact of $1.7m on the income statement and a net Group cash contribution of approximately $25m. The Plan is wound up and the Trust is closed. The transaction will be completed in 2024, pending approval of Group annuity contracts from State Regulators. There are three remaining immaterial US post-retirement benefit plans and therefore from 2024, these will not be individually disclosed. Sweden The Swedish plans account for 20% of the Group’s defined benefit obligations. They are governed by Fiduciary Bodies with responsibility for the investment of the assets. These plans are funded in line with the Group’s financing principles and local regulations. The Swedish defined benefit pension plans were actuarially valued at 31 December 2022, when plan obligations were estimated to amount to $1,312m and plan assets were $946m. The local Swedish GAAP funding position can influence contribution policy. Over 2023, for the main pension fund the Group did not request a reimbursement of benefit payments made throughout the year as the funding level was below 100% on the Swedish GAAP basis. The benefit payments over 2023, totalling approximately $47m, are therefore regarded as Group contributions. On current bases, it is expected that ongoing contributions (excluding those in respect of past service deficit contributions) during the year ending 31 December 2024 for Sweden will be approximately $53m. Other defined benefit plans The Group provides benefit plans other than pensions which have to be reported under IAS 19. These include lump sum plans, long service awards and defined contribution pension plans which have a guaranteed minimum benefit. However, the largest category of these ‘other’ non-pension plans are healthcare benefits. In the US, and to a lesser extent in certain other countries, the Group’s employment practices include the provision of healthcare and life assurance benefits for eligible retired employees. As at 31 December 2023, some 2,673 retired employees and covered dependents currently benefit from these provisions and some 2,133 current employees will be eligible on their retirement. The Group accrues for the present value of such retiree obligations over the working life of the employee. In practice, these benefits will be funded with reference to the financing principles. In the US, the Post Retirement Welfare Plan which provides retiree medical benefits has a surplus of $66m. As a result, the investment strategy has been fully de-risked. The Group has concluded that under current legislation, the surplus would be repayable in the future to subsidise other medical benefits offered to employees. The cost of post-retirement benefits other than pensions for the Group in 2023 was $1m (2022: $1m; 2021: $1m). Plan assets were $161m and plan obligations were $114m at 31 December 2023. These benefit plans have been included in the disclosure of post-retirement benefits under IAS 19. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 185 Strategic Report Corporate Governance Financial Statements Additional Information |
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22 Post-retirement and other defined benefit schemes continued Notes to the Group Financial Statements continued Financial assumptions Qualified independent actuaries have updated the actuarial valuations under IAS 19 for the major defined benefit schemes operated by the Group to 31 December 2023. The assumptions used may not necessarily be borne out in practice, due to the inherent financial and demographic uncertainty associated with making long-term projections. These assumptions reflect the changes which have the most material impact on the results of the Group and were as follows: 2022 UK US Sweden Rest of Group1 Inflation assumption 3.2% – 1.9% 2.5% Rate of increase in salaries –2 – 3.4% 4.0% Rate of increase in pensions in payment 3.1% – 1.9% 2.5% Discount rate – defined benefit obligation 4.9% 5.0% 4.1% 3.7% Discount rate – interest cost 5.0% 4.9% 4.0% 3.8% Discount rate – service cost 4.8% n/a 4.0% 3.7% 2023 UK US Sweden Rest of Group1 Inflation assumption 3.1%3 – 1.6% 2.2% Rate of increase in salaries –2 – 3.1% 3.7% Rate of increase in pensions in payment 2.9% – 1.6% 2.2% Discount rate – defined benefit obligation4 4.6% 4.7% 3.3% 3.3% Discount rate – interest cost5 4.6% 4.7% 3.3% 3.3% Discount rate – service cost5 4.5% n/a 3.3% 3.3% 1 Rest of Group reflects the assumptions in Germany as these have the most material impact on the Group. 2 Pensionable pay frozen at 30 June 2010 levels following UK fund changes. 3 The UK inflation assumption includes an allowance for some UK inflation experience over 2023. 4 Group defined benefit obligation as at 31 December 2023 calculated using discount rates based on market conditions as at 31 December 2023. 5 2023 interest costs and service costs calculated using discount rates based on market conditions as at 31 December 2022. The weighted average duration of the post-retirement scheme obligations is approximately 11 years in the UK, 16 years in Sweden and 13 years for the Rest of the Group (including Germany). Demographic assumptions The mortality assumptions are based on country-specific mortality tables. These are compared to actual experience and adjusted where sufficient data are available. Additional allowance for future improvements in life expectancy is included for all major schemes where there is credible data to support a continuing trend. The table below illustrates life expectancy assumptions at age 65 for male and female members retiring in 2023 and male and female members expected to retire in 2043 (2022: 2022 and 2042 respectively). Life expectancy assumption for a male member retiring at age 65 Life expectancy assumption for a female member retiring at age 65 Country 2023 2043 2022 2042 2023 2043 2022 2042 UK 22.1 23.1 22.2 23.2 23.7 24.8 23.8 24.9 US 22.2 24.6 22.0 23.2 23.3 26.2 23.4 25.0 Sweden 21.8 23.6 21.8 23.6 23.9 26.0 23.9 26.0 In the UK, the Group adopted the CMI 2022 Mortality Projections Model with a 1% long-term improvement rate. No other demographic assumptions have changed since they were updated in 2022 following the actuarial valuation. The Group has continued to assume that 25% of members (2022: 25%) will transfer out of the defined benefit section of the AstraZeneca Pension Fund at the point of retirement. In the US and Sweden, the mortality assumptions are unchanged from 2022. 186 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Risks associated with the Group’s defined benefit pension schemes The UK defined benefit plan accounts for 65% of the Group’s defined benefit obligations and exposes the Group to a number of risks, the most significant of which are: Risk Description Mitigation Asset pricing risk The Defined Benefit Obligation (DBO) is calculated using a discount rate set with reference to AA-rated corporate bond yields; asset returns that differ from the discount rate will create an element of volatility in the solvency ratio. Approximately 45% of the UK Pension Fund is allocated to growth assets. Although these growth assets are expected to outperform AA-rated corporate bonds in the long term, they can lead to volatility and mismatching risk in the short term. The allocation to growth assets is monitored to ensure it remains appropriate given the UK Pension Fund’s long-term objectives. In order to mitigate investment risk, the Trustee invests in a suitably diversified range of asset classes, return drivers and investment managers. The investment strategy will evolve to further improve the expected risk/return profile as opportunities arise. De-risking of the investment strategy took place over 2023, as the Fund moved ahead of its long-term target, with the benchmark allocation to Growth Assets reducing from 62.5% to 47.5%. The Trustee has hedged approximately 92% of unintended non-sterling, overseas currency risk within the UK Pension Fund assets. Interest rate risk A decrease in corporate bond yields will increase the present value placed on the DBO for accounting purposes. The interest rate hedge of the UK Pension Fund is predominantly implemented via holding gilts (and gilt repurchase agreements or ‘gilt repo’) of appropriate duration. This hedge protects to a large degree against falls in long-term interest rates and the UK Pension Fund is approximately 98% hedged as a percentage of assets at the end of 2023 (versus target of 100%). Nonetheless, there remain differences in the bonds and instruments held by the UK Pension Fund to hedge interest rate risk on the statutory and long-term funding basis (gilts and gilt repo) and the bonds analysed to set the DBO discount rate on an accounting basis (AA corporate bonds). As such, there remains some mismatching risk on an accounting basis should yields on gilts diverge compared to AA corporate bonds. Inflation risk The majority of the DBO is indexed in line with price inflation (mainly inflation as measured by the UK Retail Price Index (RPI) but also for some members a component of pensions is indexed by the UK Consumer Price Index (CPI)) and higher inflation will lead to higher liabilities (although, in the vast majority of cases, this is capped at an annual increase of 5%, known as Limited Price Indexation or LPI). The UK Pension Fund holds RPI index-linked gilts and gilt repo. The inflation hedge of the UK Pension Fund protects to some degree against higher-than-expected inflation increases on the DBO (approximately 100% hedged as a percentage of assets at the end of 2023). Over 2023, work was carried out by the Trustee to improve the accuracy of the hedge to LPI linked liabilities. Life expectancy The majority of the UK Pension Fund’s obligations are to provide benefits for the life of the member, so increases in life expectancy will result in an increase in the liabilities. In 2013 the Trustee entered into a longevity swap to hedge against the risk of increasing life expectancy over the next 75 years. The swap currently covers approximately 8,000 of the UK Pension Fund’s pensioners, equivalent to $2.4bn of Pension fund liability. A one-year increase in life expectancy would result in a $214m increase in pension fund obligations, which would be partially offset by a $108m increase in the value of the longevity swap and hence the pension fund assets. Cash flow and liquidity risk The UK Pension Fund is maturing and cash flow negative. Assets are liquidated to meet benefit outgo and potentially from time to time, to supplement the collateral pool required to post margin for derivative holdings. There is a risk of the Trustee requesting liquidity support from the Group to meet margin calls or expenditure, if the liquidity position of the UK Pension Fund is not effectively monitored and managed. The Trustee invests in a diversified portfolio of highly liquid assets to manage sequencing risk and operates a collateral management policy, maintaining a minimum liquidity ‘buffer’ above recommended regulatory guidelines, which can be quickly supplemented in an orderly manner. Over 2023, in addition to the Growth and Liability Hedging portfolios, the Trustee allocated 7% of assets to a new, cash flow driven investment portfolio, consisting of investment grade corporate bonds. The purpose of this portfolio is to generate income to help meet the Fund’s benefit outgo. The portfolio is expected to grow over time as further de-risking occurs. Other risks There are a number of other risks of administering the UK Pension Fund which the Trustee manages with Group input. Some of the major risks include counterparty risks from using derivatives (mitigated by using a specialist investment manager to oversee a diversified range of counterparties of high standing and ensuring positions are collateralised daily). Furthermore, there are operational risks (such as paying out the wrong benefits) and legislative risks (such as the UK government introducing new legislation). These are mitigated so far as possible via the governance structure in place which oversees and administers the pension funds. The Group’s pension plans in Sweden also manage these key risks, where relevant, in a similar way, with the local fiduciary bodies investing in a diversified manner and employing a framework to hedge interest rate risk where practicable. Local fiduciary boards are aware of Environmental, Social and Governance (ESG) risks as they pertain to investment policy, and where local regulation allows, have policies in place to monitor and manage such risks and comply with local legislation and disclosure requirements. The Trustee of the UK Pension Fund published its inaugural Task Force for Climate-related Disclosures (TCFD) report in October 2023. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 187 Strategic Report Corporate Governance Financial Statements Additional Information |
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22 Post-retirement and other defined benefit schemes continued Notes to the Group Financial Statements continued Assets and obligations of defined benefit schemes The assets and obligations of the defined benefit schemes operated by the Group at 31 December 2023, as calculated in accordance with IAS 19, are shown below. The fair values of the schemes’ assets are not intended to be realised in the short term and may be subject to significant change before they are realised. The present value of the schemes’ obligations is derived from cash flow projections over long periods and is therefore inherently uncertain. Scheme assets 2022 UK US Sweden Rest of Group Total Quoted Unquoted Quoted Unquoted Quoted Unquoted Quoted Unquoted Quoted Unquoted Total $m $m $m $m $m $m $m $m $m $m $m Government bonds1 1,931 – 104 – – – 60 – 2,095 – 2,095 Corporate bonds2 – – 622 – – – 11 – 633 – 633 Derivatives3 – (608) (2) (3) – 325 (2) – (4) (286) (290) Investment funds: Listed Equities4 – 265 – – – – 49 4 49 269 318 Investment funds: Absolute Return/Multi Strategy4 – 1,701 – – – 475 6 – 6 2,176 2,182 Investment funds: Corporate Bonds/Credit4 – 817 – – – 144 49 10 49 971 1,020 Cash and cash equivalents 52 415 285 – – 2 – 4 337 421 758 Other – – – 2 – – 1 311 1 313 314 Total fair value of scheme assets/(liabilities)5 1,983 2,590 1,009 (1) – 946 174 329 3,166 3,864 7,030 2023 UK US Sweden Rest of Group Total Quoted Unquoted Quoted Unquoted Quoted Unquoted Quoted Unquoted Quoted Unquoted Total $m $m $m $m $m $m $m $m $m $m $m Government bonds1 2,383 – 61 – – – 51 – 2,495 – 2,495 Corporate bonds2 373 – 94 – – – 6 – 473 – 473 Derivatives3 – (532) – – – 440 – – – (92) (92) Investment funds: Listed Equities4 – 321 – – – – 53 3 53 324 377 Investment funds: Absolute Return/Multi Strategy4 – 1,131 – – – 461 5 8 5 1,600 1,605 Investment funds: Corporate Bonds/Credit4 – 667 – – – 165 48 – 48 832 880 Cash and cash equivalents 53 363 5 – – 2 – 3 58 368 426 Other – – – – – – (1) 316 (1) 316 315 Total fair value of scheme assets5 2,809 1,950 160 – – 1,068 162 330 3,131 3,348 6,479 1 Predominantly developed markets in nature. 2 Predominantly developed markets in nature and investment grade (AAA-BBB). 3 Includes interest rate swaps, inflation swaps, longevity swap, equity total return swaps and other contracts. More detail is given in the section Risks associated with the Group’s defined benefit pensions on page 187. Valuations are determined by independent third parties. 4 Investment Funds are pooled, commingled vehicles, whereby the pension scheme owns units in the fund, alongside other investors. The pension schemes invest in a number of Investment Funds, including Listed Equities (primarily developed markets with some emerging markets), Corporate Bonds/Credit (a range of investment-grade and non investment-grade credit) and Absolute Return/Multi Strategy (multi-asset exposure both across and within traditional and alternative asset classes). The price of the funds is set by independent administrators/custodians employed by the investment managers and based on the value of the underlying assets held in the fund. Details of pricing methodology is set out within internal control reports provided for each fund. Prices are updated daily, weekly or monthly depending upon the frequency of the fund’s dealing. 5 None of the Group’s own assets were included in the scheme assets (2022: $1m). The assets held in 2022 were AstraZeneca corporate debt held by the US qualified plan and amounted to 0.05% of the plan’s then assets. Scheme obligations 2022 UK US Sweden Rest of Group Total $m $m $m $m $m Present value of scheme obligations in respect of: Active membership (212) (54) (430) (424) (1,120) Deferred membership (804) (437) (369) (299) (1,909) Pensioners (3,785) (531) (513) (250) (5,079) Total value of scheme obligations (4,801) (1,022) (1,312) (973) (8,108) 2023 UK US Sweden Rest of Group Total $m $m $m $m $m Present value of scheme obligations in respect of: Active membership (233) (45) (553) (442) (1,273) Deferred membership (853) (2) (443) (294) (1,592) Pensioners (4,075) (107) (606) (254) (5,042) Total value of scheme obligations (5,161) (154) (1,602) (990) (7,907) 188 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Net (deficit)/surplus in the scheme 2022 UK US Sweden Rest of Group Total $m $m $m $m $m Total fair value of scheme assets 4,573 1,008 946 503 7,030 Total value of scheme obligations (4,801) (1,022) (1,312) (973) (8,108) Deficit in the scheme as recognised in the Consolidated Statement of Financial Position (228) (14) (366) (470) (1,078) Included in Non-current other receivables – 62 – 281 90 Included in Retirement benefit obligations (228) (76) (366) (498) (1,168) (228) (14) (366) (470) (1,078) 2023 UK US Sweden Rest of Group Total $m $m $m $m $m Total fair value of scheme assets 4,759 160 1,068 492 6,479 Total value of scheme obligations (5,161) (154) (1,602) (990) (7,907) (Deficit)/surplus in the scheme as recognised in the Consolidated Statement of Financial Position (402) 6 (534) (498) (1,428) Included in Non-current other receivables – 66 – 261 92 Included in Retirement benefit obligations (402) (60) (534) (524) (1,520) (402) 6 (534) (498) (1,428) 1 Surpluses were recognised in Ireland and Belgium. Fair value of scheme assets 2023 2022 UK US Sweden Rest of Group Total UK US Sweden Rest of Group Total $m $m $m $m $m $m $m $m $m $m At beginning of year 4,573 1,008 946 503 7,030 7,333 1,413 1,234 584 10,564 Interest income on scheme assets 229 22 38 11 300 123 29 18 5 175 Expenses (9) (1) – (1) (11) (5) (2) – – (7) Actuarial (losses)/gains (59) 2 37 (45) (65) (1,964) (295) (153) (55) (2,467) Exchange and other adjustments 262 (1) 48 20 329 (728) – (152) (34) (914) Employer contributions 65 35 46 42 188 118 7 43 37 205 Participant contributions 1 4 – 7 12 1 5 – 5 11 Benefits paid (303) (68) (47) (45) (463) (305) (149) (44) (39) (537) Settlements – (841) – – (841) – – – – – Scheme assets’ fair value at end of year 4,759 160 1,068 492 6,479 4,573 1,008 946 503 7,030 The actual return on the plan assets was a gain of $235m (2022: loss of $2,292m). Movement in post-retirement scheme obligations 2023 2022 UK US Sweden Rest of Group Total UK US Sweden Rest of Group Total $m $m $m $m $m $m $m $m $m $m Present value of obligations in scheme at beginning of year (4,801) (1,022) (1,312) (973) (8,108) (7,941) (1,404) (2,373) (1,300) (13,018) Current service cost (6) (2) (13) (35) (56) (14) (1) (35) (38) (88) Past service credit/(cost) 12 – (2) 2 12 (5) – (4) 3 (6) Participant contributions (1) (4) – (7) (12) (1) (4) – (5) (10) Benefits paid 303 68 47 45 463 305 149 44 39 537 Interest expense on post-retirement scheme obligations (239) (22) (50) (27) (338) (132) (29) (31) (12) (204) Actuarial (losses)/gains (155) (12) (202) 28 (341) 2,243 268 806 268 3,585 Exchange and other adjustments (274) 1 (70) (34) (377) 744 (1) 281 72 1,096 Settlements – 839 – 11 850 – – – – – Present value of obligations in scheme at end of year (5,161) (154) (1,602) (990) (7,907) (4,801) (1,022) (1,312) (973) (8,108) The obligations arise from over 50 plans in 28 countries: 2023 2022 UK US Sweden Rest of Group Total UK US Sweden Rest of Group Total $m $m $m $m $m $m $m $m $m $m Funded – pension schemes1 (5,151) – (1,599) (868) (7,618) (4,787) (851) (1,310) (842) (7,790) Funded – post-retirement healthcare – (94) – – (94) – (111) – – (111) Unfunded – pension schemes1 – (60) (3) (113) (176) – (60) (2) (122) (184) Unfunded – post-retirement healthcare (10) – – (9) (19) (14) – – (9) (23) Total (5,161) (154) (1,602) (990) (7,907) (4,801) (1,022) (1,312) (973) (8,108) 1 Includes defined benefit pension schemes and other plans, such as lump sum, long service awards and DC plans with underpins. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 189 Strategic Report Corporate Governance Financial Statements Additional Information |
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22 Post-retirement and other defined benefit schemes continued Notes to the Group Financial Statements continued Consolidated Statement of Comprehensive Income disclosures The amounts that have been charged to the Consolidated Statement of Comprehensive Income, in respect of defined benefit schemes for the year ended 31 December 2023, are set out below. 2023 2022 UK US Sweden Rest of Group Total UK US Sweden Rest of Group Total $m $m $m $m $m $m $m $m $m $m Operating profit Current service cost (6) (2) (13) (35) (56) (14) (1) (35) (38) (88) Past service credit/(cost) 12 – (2) 2 12 (5) – (4) 3 (6) Expenses (9) (1) – (1) (11) (5) (2) – – (7) Total charge to Operating profit (3) (3) (15) (34) (55) (24) (3) (39) (35) (101) Finance expense Interest income on scheme assets 229 22 38 11 300 123 29 18 5 175 Interest expense on post-retirement scheme obligations (239) (22) (50) (27) (338) (132) (29) (31) (12) (204) Net interest on post-employment defined benefit plan liabilities (10) – (12) (16) (38) (9) – (13) (7) (29) Charge before taxation (13) (3) (27) (50) (93) (33) (3) (52) (42) (130) Other comprehensive income Difference between the actual return and the expected return on the post-retirement scheme assets (59) 2 37 (45) (65) (1,964) (295) (153) (55) (2,467) Experience (losses)/gains arising on the post-retirement scheme obligations (25) (2) (67) (13) (107) 55 (16) (99) (6) (66) Changes in financial assumptions underlying the present value of the post-retirement scheme obligations (142) (10) (135) 44 (243) 2,272 284 896 275 3,727 Changes in demographic assumptions 12 – – (3) 9 (84) – 9 (1) (76) Remeasurement of the defined benefit liability (214) (10) (165) (17) (406) 279 (27) 653 213 1,118 Past service cost includes granting early retirement in UK and Sweden. Total Group pension costs in respect of defined contribution and defined benefit schemes during the year are set out below (see Note 29). 2023 2022 $m $m Defined contribution schemes 482 445 Defined benefit schemes − Current service cost and Expenses 67 95 Defined benefit schemes − Past service (credit)/cost (12) 6 Pension costs 537 546 Rate sensitivities The following table shows the US dollar effect of a change in the significant actuarial assumptions used to determine the retirement benefits obligations in our three main defined benefit pension obligation countries. 2023 2022 +0.5% −0.5% +0.5% −0.5% Discount rate UK ($m) 269 (308) 262 (289) US ($m) 4 (4) 46 (49) Sweden ($m) 109 (123) 95 (107) Total ($m) 382 (435) 403 (445) 2023 2022 +0.5% −0.5% +0.5% −0.5% Inflation rate1 UK ($m) (189) 184 (173) 165 US ($m) n/a n/a n/a n/a Sweden ($m) (116) 104 (104) 93 Total ($m) (305) 288 (277) 258 2023 2022 +0.5% −0.5% +0.5% −0.5% Rate of increase in salaries UK ($m) n/a n/a n/a n/a US ($m) n/a n/a n/a n/a Sweden ($m) (46) 42 (47) 43 Total ($m) (46) 42 (47) 43 190 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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2023 2022 +1 year −1 year +1 year −1 year Mortality rate UK ($m) (214)2 2123 (191) 193 US ($m) (2) 2 (20) 20 Sweden ($m) (51) 51 (44) 44 Total ($m) (267) 265 (255) 257 1 Rate of increase in pensions in payment follows inflation. 2 Of the $214m increase, $108m is covered by the longevity swap. 3 Of the $212m decrease, $106m is covered by the longevity swap. In consideration of current market conditions, additional sensitivities have been calculated for the UK and Sweden schemes for 2023. The effect on retirement benefit obligations of a 1.0% change in assumption is as follows: $525m (UK) and $210m (Sweden) if the discount rate is increased; $(634)m (UK) and $(254)m (Sweden) if the discount rate is decreased; $(384)m (UK) and $(240)m (Sweden) if the inflation rate is increased; and $363m (UK) and $201m (Sweden) if the inflation rate is decreased. The sensitivity to the financial assumptions shown above has been estimated taking into account the approximate duration of the liabilities and the overall profile of the plan membership. The inflation sensitivity allows for the impact of a change in inflation on salary increases and pension increases (where these assumptions are inflation-linked). The salary increase sensitivity reflects the impact of an increase of only salary relative to inflation. The sensitivity to the life expectancy assumption is estimated based on a revised mortality assumption that extends/reduces the current life expectancy by one year for a particular age. 23 Reserves Retained earnings The cumulative amount of goodwill written off directly to reserves resulting from acquisitions, net of disposals, amounted to $595m (2022: $591m; 2021: $615m) using year end rates of exchange. At 31 December 2023, 1,580,137 shares, at a cost of $129m, have been deducted from Retained earnings (2022: 1,671,446 shares, at a cost of $112m; 2021: 3,922,122 shares, at a cost of $239m) to satisfy future vesting of employee share plans. There are no significant statutory or contractual restrictions on the distribution of current profits of subsidiaries; undistributed profits of prior years are, in the main, permanently employed in the businesses of these companies. The undistributed income of AstraZeneca companies overseas might be liable to overseas taxes and/or UK taxation (after allowing for double taxation relief) if they were to be distributed as dividends (see Note 4). 2023 2022 2021 $m $m $m Cumulative translation differences included within Retained earnings At 1 January (3,694) (1,934) (1,143) Foreign exchange arising on consolidation 608 (1,446) (483) Exchange adjustments on goodwill (recorded against other reserves) 4 (24) (21) Foreign exchange arising on designated liabilities in net investment hedges1 24 (282) (321) Fair value movements on derivatives designated in net investment hedges 44 (8) 34 Net exchange movement in Retained earnings 680 (1,760) (791) At 31 December (3,014) (3,694) (1,934) 1 Foreign exchange arising on designated liabilities in net investment hedges includes $(57)m in respect of designated bonds and $81m in respect of designated contingent consideration and other liabilities. The change in value of designated contingent consideration liabilities relates to $82m in respect of BMS’ share of Global Diabetes Alliance. The cumulative loss with respect to costs of hedging is $22m (2022: loss of $3m; 2021: gain of $4m) and the loss during the year was $19m (2022: loss of $7m; 2021: loss of $6m). The balance remaining in the foreign currency translation reserve from net investment hedging relationships for which hedge accounting no longer applied is a gain of $527m. For further detail relating to hedging balances, please see the Hedge accounting section within Note 28, from page 200. Other reserves The other reserves arose from the cancellation of £1,255m of share premium account by the Company in 1993 and the redenomination of share capital of $157m in 1999. The reserves are available for writing off goodwill arising on consolidation and, subject to guarantees given to preserve creditors at the date of the court order, are available for distribution. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 191 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 24 Share capital Allotted, called-up and fully paid 2023 2022 2021 $m $m $m Issued Ordinary Shares ($0.25 each) 388 387 387 Redeemable Preference Shares (£1 each – £50,000) – – – At 31 December 388 387 387 The Redeemable Preference Shares carry limited class voting rights and no dividend rights. This class of shares is capable of redemption at par at the option of the Company on the giving of seven days’ written notice to the registered holder of the shares. The Company does not have a limited amount of authorised share capital. The movements in the number of Ordinary Shares during the year can be summarised as follows: No. of shares 2023 2022 2021 At 1 January 1,549,800,030 1,549,400,665 1,312,668,724 Issue of share capital (business combinations) – – 236,321,411 Issue of shares (share schemes) 362,596 399,365 410,530 At 31 December 1,550,162,626 1,549,800,030 1,549,400,665 Share issues Issue of share capital (business combinations) represents share capital issued as part of the acquisition of Alexion (see Note 27). Share repurchases No Ordinary Shares were repurchased by the Company in 2023 (2022: nil; 2021: nil). Shares held by subsidiaries No shares in the Company were held by subsidiaries in any year. 25 Dividends to shareholders 2023 2022 2021 2023 2022 2021 Per share Per share Per share $m $m $m Second interim (March 2023) $1.97 $1.97 $1.90 3,047 3,046 2,490 First interim (September 2023) $0.93 $0.93 $0.90 1,440 1,440 1,392 Total $2.90 $2.90 $2.80 4,487 4,486 3,882 The Company has exercised its authority in accordance with the provisions set out in the Company’s Articles of Association, that the balance of unclaimed dividends outstanding past 12 years be forfeited. Unclaimed dividends of $nil (2022: $1m; 2021: $nil) have been adjusted for in Retained earnings in 2023. The 2022 second interim dividend of $1.97 per share was paid on 27 March 2023. The 2023 first interim dividend of $0.93 per share was paid on 11 September 2023. Reconciliation of dividends charged to equity to cash flow statement: 2023 2022 2021 $m $m $m Dividends charged to equity 4,487 4,486 3,882 Exchange losses on payment of dividend 5 5 3 Hedge contracts relating to payment of dividends (cash flow statement) (19) (127) (29) Dividends paid to non-controlling interests 4 – – Net movement of unclaimed dividends in the year 4 – – Dividends paid (cash flow statement) 4,481 4,364 3,856 192 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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26 Non-controlling interests The Group Financial Statements at 31 December 2023 reflect equity of $23m (2022: $21m; 2021: $19m) and total comprehensive income of $6m (2022: $2m; 2021: $3m) attributable to the non-controlling interests in AstraZeneca Pharma India Limited, P.T. AstraZeneca Indonesia, Beijing Falikang Pharmaceutical (China) Co. Limited, and AstraZeneca Algeria Pharmaceutical Industries SPA. In February 2016, AstraZeneca acquired a 55% controlling stake in Acerta Pharma where the non-controlling interest was subject to put and call options. The put option gave rise to a liability (see Note 20). AstraZeneca exercised its option to acquire the remaining 45% of shares in Acerta Pharma in April 2021. As part of the acquisition of Alexion in July 2021, a pre-existing non-controlling interest in Caelum Biosciences was recognised (Note 27). This was valued at $150m, the agreed-upon exercise price for the exclusive option to acquire the remaining equity. The option was exercised on 28 September 2021 and the acquisition of Caelum Biosciences closed shortly thereafter on 5 October 2021. 27 Acquisition of business operations Acquisitions of business operations in 2023 On 16 January 2023, AstraZeneca completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts). The purchase price allocation exercise has completed, with the fair value of total consideration determined at $267m. Intangible assets of $100m and goodwill of $158m were recognised in the acquisition balance sheet, as well as a cash outflow of $189m net of cash acquired. Future contingent milestones-based and non-contingent consideration is payable to a maximum of $120m. Neogene’s results have been consolidated into the Group’s results from 16 January 2023. Acquisitions of business operations in 2022 On 16 November 2022, AstraZeneca completed the acquisition of 100% of the issued shares of LogicBio Therapeutics, Inc. (LogicBio) based in Lexington, MA, US. LogicBio is a clinical-stage genetic medicine company pioneering genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The total consideration was $72m. Cash of $68m was paid on the completion date, with $4m of outstanding options, which will be settled in cash, recorded in current Trade and other payables. Goodwill of $15m, assets of $82m, including $46m of intangible assets, and liabilities of $25m were recognised on acquisition. LogicBio’s results have been consolidated into the Group’s results from 16 November 2022. Acquisitions of business operations in 2021 On 21 July 2021, AstraZeneca completed the acquisition of 100% of the issued shares of Alexion Pharmaceuticals, Inc (Alexion), based in Boston, MA, US. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialisation of life-changing medicines. At closing, Alexion shareholders received 2.1243 AstraZeneca American Depositary Shares (ADSs) and $60 in cash for each of their Alexion shares. Unvested Alexion employee share awards were converted to equivalent AstraZeneca share awards. The fair value of the purchase consideration was $41,058m, comprising AstraZeneca ADSs of $27,196m, cash of $13,349m and replacement employee share awards of $513m. The Group funded the cash element of the acquisition with $8bn of new long-term debt, issued in May and June 2021, $4bn of term loans drawn in July 2021 under the $17.5bn committed bank facilities entered into in December 2020 to secure the acquisition financing, and existing cash balances. The Group cancelled the remaining $13.5bn of the facilities in June, July and October 2021. Loans and borrowings of $2.3bn acquired with Alexion were repaid in full shortly following completion of the acquisition. The acquisition was accounted for as a business combination using the acquisition method of accounting in accordance with IFRS 3 ‘Business Combinations’ and consequently the Alexion assets acquired, and liabilities assumed, were recorded by AstraZeneca at fair value, with the excess of the purchase price over the fair value of the identifiable assets and liabilities being recognised as goodwill. As part of the Alexion acquisition in 2021, we identified the assets (comprising principally launched products and IPR&D post pre-clinical stage) and liabilities acquired. Attributing fair values to assets acquired and liabilities assumed as part of business combinations is considered to be a key judgement. The purchase price allocation was performed with assistance from an independent valuer to advise on the valuation techniques and key assumptions in the valuation, in particular in respect of the valuation of the intangible assets and inventory. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 193 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 27 Acquisition of business operations continued The fair values assigned to the Alexion business combination in 2021 were: Fair value $m Non-current assets Property, plant and equipment 1,135 Right-of-use assets 263 Intangible assets 26,855 Other non-current assets 301 28,554 Current assets Inventories 6,769 Trade and other receivables 2,096 Intangible assets 100 Cash and cash equivalents 4,086 13,051 Current liabilities Interest-bearing loans and borrowings (2,336) Trade and other payables (1,192) Other current liabilities (40) (3,568) Non-current liabilities Lease liabilities (228) Deferred tax liabilities (4,191) Other non-current liabilities (697) (5,116) Total net assets acquired 32,921 Less: non-controlling interests (150) Goodwill 8,287 Total fair value of consideration 41,058 Less: fair value of equity consideration (27,196) Less: fair value of replacement employee share awards (513) Less: cash and cash equivalents acquired (4,086) Net cash outflow 9,263 The estimated fair value and useful lives of intangible assets were as follows: Fair value Useful lives $m Years Launched products – C5 franchise (Soliris/Ultomiris) 18,480 6 to 15 Launched products – Strensiq, Kanuma, Andexxa 5,215 11 to 17 Products in development 2,760 Not amortised Other intangibles 500 5 to 10 26,955 The fair value attributed to intangible assets was $26,955m and primarily represents intellectual property rights over launched products of $23,695m and products under development of $2,760m. These were fair valued using the multi-period excess earnings method, which uses a number of estimates regarding the amount and timing of future cash flows. The key assumptions in the cash flows are the probability of technical and regulatory success, peak year sales and revenue erosion curves. In accordance with the Group’s policy on impairment assessments as set out on page 159, the assets were assessed for impairment in the final quarter of 2023, 2022 and 2021. Future milestones have been included in the valuation of the intangible assets (as a deduction of cash flows). The fair value of inventory, which includes raw materials, work in progress and finished goods related to the launched products was estimated at $6,769m, an uplift of $5,635m on the carrying value prior to the acquisition. The fair value adjustment relates only to work in progress and finished goods and was calculated as the estimated selling price less costs to complete and sell the inventory, associated margins on these activities and holding costs. As at 31 December 2023, the fair value uplift has been fully unwound. Property, plant and equipment principally comprises the manufacturing facilities in Dublin and Athlone, Ireland and was fair valued using a cost approach. The estimated fair value of $1,135m represents an uplift of $111m over carrying value. The estimated fair value of contingent liabilities was $76m, relating to various claims and disputes in each case where there is a possible, but not probable, future financial exposure, and involve an assessment of the likelihood of a number of scenarios in relation to those matters. This amount has been included within other non-current liabilities of $697m. The estimated fair value of trade and other receivables was $2,096m, which approximated the contractual cash flows. The net deferred tax position reflected an adjustment of $5,215m related to the deferred tax impact of the fair value uplifts on intangible assets, inventories, property, plant and equipment and contingent liabilities as described above. 194 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Goodwill amounting to $8,287m was recognised on acquisition and is underpinned by a number of elements, which individually could not be quantified. Most significant among these is the premium attributable to a pre-existing, well-positioned business in the innovation-intensive, high-growth rare diseases market with a highly skilled workforce and established reputation. Other important elements include the potential unidentified products that future research and development may yield and the core technological capabilities and knowledge base of the company. Goodwill is not expected to be deductible for tax purposes. Non-controlling interests reflect Alexion’s pre-existing minority equity interest in Caelum Biosciences and have been valued at $150m, the agreed-upon exercise price for the exclusive option to acquire the remaining equity. The option was exercised on 28 September 2021 and the acquisition of Caelum Biosciences closed shortly thereafter on 5 October 2021 (Note 26). Alexion’s results have been consolidated into the Group’s results from 21 July 2021. For the period from acquisition to 31 December 2021, before reflecting the fair value adjustments arising on the acquisition, Alexion’s Total Revenues were $3,071m and Profit after tax was $889m. If the acquisition had taken effect at the beginning of the reporting period in which the acquisition occurred (1 January 2021), on a pro forma basis, after reflecting the fair value adjustments arising on the acquisition, the Total Revenue of the combined Group for the year ended 31 December 2021 would have been $41,132m and the Loss after tax would have been $1,152m. This pro forma information does not purport to represent the results of the combined Group that actually would have occurred had the acquisition taken place on 1 January 2021 and should not be taken to be representative of future results. Total acquisition-related costs of $5m (2022: $4m; 2021: $171m) have been incurred by the Group, which include advisory, legal and other professional fees. These costs are presented in the Statement of Comprehensive Income within Selling, general and administrative expense and Finance expense. The terms of the acquisition include a retention bonus plan for legacy Alexion employees whereby up to $50m may be used for retention bonus awards to employees at the level of Vice President or below. In 2023, $nil costs were recorded in the Statement of Comprehensive Income (2022: $3m; 2021: $24m). These bonuses vested and were paid six months after the acquisition, or earlier. Upon completion of the acquisition, all unvested Alexion employee share awards were converted into AstraZeneca restricted stock awards that continue to have, and shall be subject to, the same terms and conditions as applied in the corresponding Alexion awards immediately prior to completion. Alexion Performance Stock Plan (PSU) awards that included performance-based vesting conditions were converted using the greater of the original target level and Alexion’s assessment of the level of achievement immediately prior to completion (subject to a limit of 175% for the awards granted in 2019 and a limit of 150% for the awards granted in 2020). In the year, a cost of $48m (2022: $257m; 2021: $257m) has been recorded in the Statement of Comprehensive Income, $nil (2022: $9m; 2021: $9m) in Cost of sales, $16m (2022: $92m; 2021: $73m) in Research and development expense and $32m (2022: $156m; 2021: $175m) in Selling, general and administrative expense. Payments made to the Employee Benefit Trust upon vesting of share awards recognised as part of the consideration for the acquisition of Alexion are recognised within investing activities in the Group’s Statement of Cash Flows as the cash payment relates to the settlement of the obligation that arose on the acquisition of Alexion that was included as part of the consideration for the acquisition. 28 Financial risk management objectives and policies The Group’s principal financial instruments, other than derivatives, comprise bank overdrafts, loans and other borrowings, lease liabilities, current and non-current investments, cash and short-term deposits. The main purpose of these financial instruments is to manage the Group’s funding and liquidity requirements. The Group has other financial assets and liabilities such as trade receivables and trade payables, which arise directly from its operations. The principal financial risks to which the Group is exposed are those of liquidity, interest rate, foreign currency and credit. Each of these is managed in accordance with Board-approved policies. These policies, together with the Group’s approach to capital management, are set out below. Capital management The capital structure of the Group consists of Shareholders’ equity (Note 24), Debt (Note 19), Other current investments (Note 12) and Cash (Note 17). For the foreseeable future, the Board will maintain a capital structure that supports the Group’s strategic objectives through: > managing funding and liquidity risk > optimising shareholder return > maintaining a strong, investment-grade credit rating. The Group utilises factoring arrangements and bank acceptance drafts discounting for selected trade receivables. These arrangements qualify for full derecognition of the associated trade receivables under IFRS 9. Amounts due on invoices that have not been factored at year end, from customers that are subject to these arrangements, are disclosed in Note 16. Funding and liquidity risk are reviewed regularly by the Board and managed in accordance with the policies described below. The Board regularly reviews its shareholders’ distribution policy, which comprises a regular cash dividend and potentially a share repurchase component. No share repurchases have been made since 2012. The Group’s net debt position (loans and borrowings net of Cash and cash equivalents, Other investments and Derivative financial instruments) has decreased from a net debt position of $22,923m at the beginning of the year to a net debt position of $22,510m at 31 December 2023. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 195 Strategic Report Corporate Governance Financial Statements Additional Information |
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28 Financial risk management objectives and policies continued Notes to the Group Financial Statements continued Liquidity risk The Board reviews the Group’s ongoing liquidity risks annually as part of the planning process and on an ad hoc basis. The Board considers short-term requirements against available sources of funding, taking into account forecast cash flows. The Group manages liquidity risk by maintaining access to a number of sources of funding which are sufficient to meet anticipated funding requirements. Specifically, the Group uses US and European commercial paper, bank loans, committed bank facilities and cash resources to manage short-term liquidity and manages long-term liquidity by raising funds through the capital markets. At 31 December 2023, the Group was assigned short-term credit ratings of P-1 by Moody’s and A-1 by Standard and Poor’s. The Group’s long-term credit rating was A2 Stable outlook by Moody’s and A Stable outlook by Standard and Poor’s. In addition to Cash and cash equivalents of $5,840m, short-term fixed income investments of $20m, less overdrafts of $203m at 31 December 2023, the Group has committed bank facilities of $6,875m available to manage liquidity. These committed bank facilities have no financial covenants. $2,000m mature in February 2025. The maturity of the $4,875m facilities was extended in February 2024 from April 2026 to April 2029. The Group regularly monitors the credit standing of the banks providing the facilities and currently does not anticipate any issue with drawing on the committed facilities should this be necessary. Advances under these facilities currently bear an interest rate per annum based on SOFR (Secured Overnight Financing Rate) plus a margin. At 31 December 2023, the Group has $4,855m outstanding from debt issued under a Euro Medium Term Note programme and $19,959m under a SEC-registered programme. The funds made available under these facility agreements may be used for the general corporate purposes of the Group. The maturity profile of the anticipated future contractual cash flows including interest in relation to the Group’s financial liabilities, on an undiscounted basis and which, therefore, differs from both the carrying value and fair value, is as follows: Bank Total Derivative Derivative Total overdrafts Trade non-derivative financial financial derivative and other Bonds and Lease and other financial instruments instruments financial loans bank loans liability payables instruments receivable payable instruments Total $m $m $m $m $m $m $m $m $m Within one year 387 1,981 256 19,007 21,631 (11,766) 11,774 8 21,639 In one to two years – 5,647 210 2,521 8,378 (55) 66 11 8,389 In two to three years – 5,242 163 1,669 7,074 (1,060) 1,079 19 7,093 In three to four years – 2,591 130 862 3,583 (35) 39 4 3,587 In four to five years – 2,970 96 233 3,299 (118) 111 (7) 3,292 In more than five years – 19,727 221 2,212 22,160 (1,521) 1,480 (41) 22,119 387 38,158 1,076 26,504 66,125 (14,555) 14,549 (6) 66,119 Effect of interest – (8,609) – – (8,609) 299 (325) (26) (8,635) Effect of discounting, fair values and issue costs – (142) (89) (2,633) (2,864) (36) 7 (29) (2,893) 31 December 2021 387 29,407 987 23,871 54,652 (14,292) 14,231 (61) 54,591 Bank Total Derivative Derivative Total overdrafts Trade non-derivative financial financial derivative and other Bonds and Lease and other financial instruments instruments financial loans bank loans liability payables instruments receivable payable instruments Total $m $m $m $m $m $m $m $m $m Within one year 365 5,777 249 19,065 25,456 (12,445) 12,478 33 25,489 In one to two years – 5,233 208 2,086 7,527 (1,012) 1,078 66 7,593 In two to three years – 2,608 172 872 3,652 (34) 38 4 3,656 In three to four years – 2,983 128 595 3,706 (103) 103 – 3,706 In four to five years – 1,267 84 814 2,165 (32) 35 3 2,168 In more than five years – 18,156 184 3,177 21,517 (1,436) 1,378 (58) 21,459 365 36,024 1,025 26,609 64,023 (15,062) 15,110 48 64,071 Effect of interest (15) (7,982) – – (7,997) 227 (249) (22) (8,019) Effect of discounting, fair values and issue costs – (113) (72) (3,299) (3,484) 63 7 70 (3,414) 31 December 2022 350 27,929 953 23,310 52,542 (14,772) 14,868 96 52,638 Bank Total Derivative Derivative Total overdrafts Trade non-derivative financial financial derivative and other Bonds and Lease and other financial instruments instruments financial loans bank loans liability payables instruments receivable payable instruments Total $m $m $m $m $m $m $m $m $m Within one year 542 5,469 313 22,401 28,725 (11,302) 11,366 64 28,789 In one to two years – 2,764 261 1,482 4,507 (100) 114 14 4,521 In two to three years – 3,137 208 788 4,133 (164) 179 15 4,148 In three to four years – 2,230 138 625 2,993 (924) 883 (41) 2,952 In four to five years – 3,822 88 12 3,922 (949) 971 22 3,944 In more than five years – 17,995 271 35 18,301 (1,507) 1,340 (167) 18,134 542 35,417 1,279 25,343 62,581 (14,946) 14,853 (93) 62,488 Effect of interest (27) (8,270) – – (8,297) 589 (644) (55) (8,352) Effect of discounting, fair values and issue costs – (168) (151) (309) (628) 44 (46) (2) (630) 31 December 2023 515 26,979 1,128 25,034 53,656 (14,313) 14,163 (150) 53,506 Where interest payments are on a floating rate basis, it is assumed that rates will remain unchanged from the last business day of each year ended 31 December. 196 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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The Group has $2bn of bank loans that mature in July 2024 which the Group can repay before maturity at face value. Other than that, it is not expected that the cash flows in the maturity profile could occur significantly earlier or at significantly different amounts, with the exception of $2,137m of contingent consideration held within Trade and other payables (see Note 20). Market risk Interest rate risk The Group maintains a Board-approved mix of fixed and floating rate debt and uses underlying debt, interest rate swaps and forward rate agreements to manage this mix. The majority of surplus cash is currently invested in US dollar liquidity funds and investment-grade fixed income securities. The interest rate profile of the Group’s interest-bearing financial instruments are set out below. In the case of current and non-current financial liabilities, the classification includes the impact of interest rate swaps which convert the debt to floating rate. 2023 2022 2021 Fixed rate Floating rate Total Fixed rate Floating rate Total Fixed rate Floating rate Total $m $m $m $m $m $m $m $m $m Financial liabilities Current 2,885 2,515 5,400 2,476 3,066 5,542 1,232 661 1,893 Non-current 23,222 – 23,222 21,511 2,179 23,690 23,985 4,903 28,888 Total 26,107 2,515 28,622 23,987 5,245 29,232 25,217 5,564 30,781 Financial assets Fixed deposits – – – 64 – 64 53 – 53 Cash collateral pledged to counterparties – 102 102 – 162 162 – – – Cash and cash equivalents – 5,840 5,840 250 5,916 6,166 – 6,329 6,329 Total – 5,942 5,942 314 6,078 6,392 53 6,329 6,382 In addition to the financial assets above, there are $11,288m (2022: $9,546m; 2021: $8,765m) of other current and non-current asset investments and other financial assets. The Group is also exposed to market risk on other investments. 2023 2022 2021 $m $m $m Equity securities at fair value through Other comprehensive income (Note 12) 1,530 1,056 1,168 Non-current fixed income securities at fair value through profit or loss (Note 12) – 10 – Total 1,530 1,066 1,168 Foreign currency risk The US dollar is the Group’s most significant currency. As a consequence, the Group results are presented in US dollars and exposures are managed against US dollars accordingly. Translational Approximately 60% of Group external sales in 2023 were denominated in currencies other than the US dollar, while a significant proportion of manufacturing, and research and development costs were denominated in pound sterling and Swedish krona. Surplus cash generated by business units is substantially converted to, and held centrally in, US dollars. As a result, operating profit and total cash flow in US dollars will be affected by movements in exchange rates. This currency exposure is managed centrally, based on forecast cash flows. The impact of movements in exchange rates is mitigated significantly by the correlations which exist between the major currencies to which the Group is exposed and the US dollar. Monitoring of currency exposures and correlations is undertaken on a regular basis and hedging is subject to pre-execution approval. As at 31 December 2023, before the impact of derivatives, 2% of interest-bearing loans and borrowings were denominated in pound sterling and 16% were denominated in euros. Where there is non-US dollar debt and an underlying net investment of that amount in the same currency, the Group applies net investment hedging. Exchange differences on the retranslation of debt designated as net investment hedges are recognised in Other comprehensive income to the extent that the hedge is effective. Any ineffectiveness is taken to profit. For details of non-US dollar debt in a designated hedging relationship please see the Hedge accounting section within this Note 28 from page 200. The Group holds cross-currency swaps to hedge against the impact of fluctuations in foreign exchange rates. Fair value movements on the revaluation of the cross-currency swaps are recognised in Other comprehensive income to the extent that the hedge is effective, with any ineffectiveness taken to profit. As at 31 December 2023, the Group operates in three countries designated as hyperinflationary, being Argentina, Venezuela and Turkey. The foreign exchange risk of these markets has been assessed and deemed to be immaterial. Transactional The Group aims to hedge all its forecasted major transactional currency exposures on working capital balances, which typically extend for up to three months. Where practicable, these are hedged using forward foreign exchange contracts. In addition, external dividend payments in pound sterling to UK shareholders and in Swedish krona to Swedish shareholders are fully hedged from announcement date to payment date. Foreign exchange gains and losses on forward contracts transacted for transactional hedging are taken to profit or to Other comprehensive income if the contract is in a designated cash flow hedge. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 197 Strategic Report Corporate Governance Financial Statements Additional Information |
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28 Financial risk management objectives and policies continued Notes to the Group Financial Statements continued Sensitivity analysis The sensitivity analysis set out below summarises the sensitivity of the market value of our financial instruments to hypothetical changes in market rates and prices. The range of variables chosen for the sensitivity analysis reflects our view of changes which are reasonably possible over a one-year period. Market values are the present value of future cash flows based on market rates and prices at the valuation date. For long-term debt, an increase in interest rates results in a decline in the fair value of debt. The sensitivity analysis assumes an instantaneous 100 basis point change in interest rates in all currencies from their levels at 31 December 2023, with all other variables held constant. Based on the composition of our long-term debt portfolio and cash reserves as at 31 December 2023, a 1% increase in interest rates would result in an additional $25m in interest expense on the debt and an additional $58m interest income on the cash reserves. The exchange rate sensitivity analysis assumes an instantaneous 10% change in foreign currency exchange rates from their levels at 31 December 2023, with all other variables held constant. The +10% case assumes a 10% strengthening of the US dollar against all other currencies and the -10% case assumes a 10% weakening of the US dollar. Each incremental 10% movement in foreign currency exchange rates would have approximately the same effect as the initial 10% detailed in the table below and each incremental 1% change in interest rates would have approximately the same effect as the 1% detailed in the table below. Interest rates Exchange rates 31 December 2021 +1% −1% +10% −10% Increase/(decrease) in fair value of financial instruments ($m) 1,978 (2,106) 82 (85) Impact on profit: gain/(loss) ($m) – – 24 (9) Impact on equity: gain/(loss) ($m) – – 58 (76) Interest rates Exchange rates 31 December 2022 +1% −1% +10% −10% Increase/(decrease) in fair value of financial instruments ($m) 1,317 (1,490) 81 (89) Impact on profit: gain/(loss) ($m) – – 26 (15) Impact on equity: gain/(loss) ($m) – – 55 (74) Interest rates Exchange rates 31 December 2023 +1% −1% +10% −10% Increase/(decrease) in fair value of financial instruments ($m) 1,361 (1,534) 196 (212) Impact on profit: gain/(loss) ($m) – – 134 (128) Impact on equity: gain/(loss) ($m) – – 62 (83) Credit risk The Group is exposed to credit risk on financial assets, such as cash investments, derivative instruments, and Trade and other receivables. The Group was also exposed in its Net asset position to its own credit risk in respect of the 2023 debentures which are accounted for at FVPL. Under IFRS 9, the effect of the losses and gains arising from own credit risk on the fair value of bonds designated at FVPL are recorded in Other comprehensive income. Financial counterparty credit risk The majority of the AstraZeneca Group’s cash is centralised within the Group treasury entity and is subject to counterparty risk on the principal invested. The level of the Group’s cash investments and hence credit risk will depend on the cash flow generated by the Group and the timing of the use of that cash. The credit risk is mitigated through a policy of prioritising security and liquidity over return and, as such, cash is only invested in high credit-quality investments. Counterparty limits are set according to the assessed risk of each counterparty and exposures are monitored against these limits on a regular basis. The Group’s principal financial counterparty credit risks at 31 December 2023 were as follows: Current assets 2023 2022 2021 $m $m $m Cash at bank and in hand 1,325 1,411 1,461 Money market liquidity funds 4,425 4,486 4,772 Other short-term cash equivalents 90 269 96 Total Cash and cash equivalents (Note 17) 5,840 6,166 6,329 Fixed income securities at fair value through profit or loss (Note 12) 20 13 16 Cash collateral pledged to counterparties (Note 12) 102 162 – Fixed deposits (Note 12) – 64 53 Total derivative financial instruments (Note 13) 116 87 83 Current assets subject to credit risk 6,078 6,492 6,481 Non-current assets 2023 2022 2021 $m $m $m Derivative financial instruments (Note 13) 228 74 102 Non-current assets subject to credit risk 228 74 102 198 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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The majority of the Group’s cash is invested in US dollar AAA-rated money market liquidity funds. The money market liquidity fund portfolios are managed by six external third-party fund managers to maintain an AAA rating. The Group’s investments represent no more than 10% of each overall fund value. There were no other significant concentrations of financial credit risk at the reporting date. All financial derivatives are transacted with commercial banks, in line with standard market practice. The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral, for the benefit of the other, equivalent to the market valuation of the derivative positions above a predetermined threshold. The carrying value of such cash collateral held by the Group at 31 December 2023 was $215m (2022: $89m; 2021: $93m) and the carrying value of such cash collateral posted by the Group at 31 December 2023 was $102m (2022: $162m; 2021: $47m). The impairment provision for other financial assets at 31 December 2023 was immaterial. Trade receivables Trade receivable exposures are managed locally in the operating units where they arise and credit limits are set as deemed appropriate for the customer. The Group is exposed to customers ranging from government-backed agencies and large private wholesalers to privately owned pharmacies, and the underlying local economic and sovereign risks vary throughout the world. Where appropriate, the Group endeavours to minimise risks by the use of trade finance instruments such as letters of credit and insurance. The Group applies the expected credit loss approach to establish an allowance for impairment that represents its estimate of expected losses in respect of Trade receivables. The Group applies the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime expected loss allowance to Trade receivables. To measure expected credit losses, Trade receivables have been grouped based on shared credit characteristics and the days past due. The expected loss rates are based on payment profiles over a period of 36 months before 31 December 2023, 31 December 2022 or 31 December 2021 respectively and the corresponding historical credit losses experienced within this period. The historical loss rates are adjusted to reflect current and forward-looking information on macroeconomic factors affecting the ability of the customer to settle the receivables. On that basis, the loss allowance was determined as follows: 0-90 days 90-180 days Over 180 days 31 December 2021 Current past due past due past due Total Expected loss rate 0.1% 1.2% 22.6% 11.0% Gross carrying amount ($m) 5,617 328 18 91 6,054 Loss allowance ($m) 5 4 4 10 23 0-90 days 90-180 days Over 180 days 31 December 2022 Current past due past due past due Total Expected loss rate 0.03% 0.3% 32.0% 40.6% Gross carrying amount ($m) 6,791 331 50 99 7,271 Loss allowance ($m) 2 1 16 40 59 0-90 days 90-180 days Over 180 days 31 December 2023 Current past due past due past due Total Expected loss rate 0.01% 0.3% 0.8% 15.0% Gross carrying amount ($m) 7,709 342 121 280 8,452 Loss allowance ($m) 1 1 1 42 45 Trade receivables are written off where there is no reasonable expectation of recovery. Impairment losses on Trade receivables are presented as net impairment losses within Operating profit, any subsequent recoveries are credited against the same line. In the US, sales to three wholesalers accounted for approximately 80% of US sales (2022: three wholesalers accounted for approximately 73%; 2021: three wholesalers accounted for approximately 94%). The movements of the Group expected credit losses provision are follows: 2023 2022 2021 $m $m $m At 1 January 59 23 23 Net movement recognised in income statement (14) 37 (2) Amounts utilised, exchange and other movements – (1) 2 At 31 December 45 59 23 Given the profile of our customers, including large wholesalers and government-backed agencies, no further credit risk has been identified with the Trade receivables not past due other than those balances for which an allowance has been made. The income statement credit or charge is recorded in Operating profit. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 199 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 28 Financial risk management objectives and policies continued Hedge accounting The Group uses foreign currency borrowings, foreign currency forwards and swaps, currency options, interest rate swaps and cross-currency interest rate swaps for the purpose of hedging its foreign currency and interest rate risks. The Group may designate certain financial instruments as fair value hedges, cash flow hedges or net investment hedges in accordance with IFRS 9. Hedge effectiveness is determined at the inception of the hedge relationship, and through periodic prospective effectiveness assessments to ensure that an economic relationship exists between the hedged item and hedging instrument. Sources of hedge effectiveness will depend on the hedge relationship designation but may include: > a significant change in the credit risk of either party to the hedging relationship > a timing mismatch between the hedging instrument and the hedged item > movements in foreign currency basis spread for derivatives in a fair value hedge > a significant change in the value of the foreign currency-denominated net assets of the Group in a net investment hedge. The hedge ratio for each designation will be established by comparing the quantity of the hedging instrument and the quantity of the hedged item to determine their relative weighting; for all of the Group’s existing hedge relationships the hedge ratio has been determined as 1:1. Designated hedges are expected to be effective and therefore the impact of ineffectiveness on profit is not expected to be material. The accounting treatment for fair value hedges and debt designated as FVPL is disclosed in the Group Accounting Policies section from page 152. The following table represents the Group’s continuing designated hedge relationships under IFRS 9. 2021 Other comprehensive income Fair value loss Opening Fair value recycled Closing Nominal balance (gain)/loss to the balance Average amounts Carrying 1 January deferred Income 31 December Average Average pay in local value 2021 to OCI statement 2021 maturity USD FX interest currency $m $m $m $m $m year rate rate Cash flow hedges – foreign currency and interest rate risk1, 3, 4 Cross currency interest rate swaps – Euro bonds EUR 1,700m (43) 46 182 (201) 27 2026 1.14 USD 2.85% FX Forwards − short-term FX risk USD 1,220m 12 (5) – (7) (12) 2022 – – Net investment hedge – foreign exchange risk2, 3 Transactions matured pre-2021 – (565) – – (565) – – – Cross currency interest rate swap – JPY investment JPY 58.3bn 62 (19) (43) – (62) 2029 108.03 JPY 1.53% Cross currency interest rate swap – CNY investment CNY 458m (2) 2 – – 2 2026 6.68 CNY 4.80% Foreign currency borrowing – GBP investment GBP 350m 470 (233) (5) – (238) 2031 n/a GBP 5.75% Foreign currency borrowing – EUR investment5 EUR 450m – 85 (47) – 38 2021 n/a EUR 0.88% Foreign currency borrowing – EUR investment6 EUR 800m 898 – (50) – (50) 2029 n/a EUR 0.38% Contingent consideration liabilities and Acerta Pharma share purchase liability – AZUK and AZAB USD investments USD 2,658m (2,658) 1,411 421 – 1,832 – – – 2022 Other comprehensive income Fair value (gain)/loss Opening Fair value recycled Closing Nominal balance (gain)/loss to the balance Average amounts Carrying 1 January deferred Income 31 December Average Average pay in local value 2022 to OCI statement 2022 maturity USD FX interest currency $m $m $m $m $m year rate rate Cash flow hedges – foreign currency and interest rate risk1, 3, 4 Cross currency interest rate swaps – Euro bonds EUR 1,700m (160) 27 118 (111) 34 2026 1.14 USD 2.85% FX Forwards − short-term FX risk USD 1,126m (12) (12) (14) 38 12 2023 – – Net investment hedge – foreign exchange risk2, 3 Transactions matured pre-2022 – (527) – – (527) – – – Cross currency interest rate swap – JPY investment JPY 58.3bn 55 (62) 7 – (55) 2029 108.03 JPY 1.53% Cross currency interest rate swap – CNY investment CNY 458m (4) 2 2 – 4 2026 6.68 CNY 4.80% Foreign currency borrowing – GBP investment GBP 350m 420 (238) (50) – (288) 2031 n/a GBP 5.75% Foreign currency borrowing – EUR investment6 EUR 800m 846 (50) (52) – (102) 2029 n/a EUR 0.38% Contingent consideration liabilities and Acerta Pharma share purchase liability – AZUK and AZAB USD investments USD 2,093m (2,093) 1,832 384 – 2,216 – – – 200 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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2023 Other comprehensive income Fair value (gain)/loss Opening Fair value recycled Closing Nominal balance (gain)/loss to the balance Average amounts Carrying 1 January deferred Income 31 December Average Average pay in local value 2023 to OCI statement 2023 maturity USD FX interest currency $m $m $m $m $m year rate rate Cash flow hedges – foreign currency and interest rate risk2, 4, 5 Cross currency interest rate swaps – Euro bonds EUR 3,200m 49 34 (210) 139 (37) 2027 1.10 USD 3.80% FX Forwards − short-term FX risk USD 2,009m 15 12 (33) 6 (15) 2024 – – Net investment hedge – foreign exchange risk3, 4 Transactions matured pre-2023 – (527) – – (527) – – – Cross currency interest rate swap – JPY investment JPY 58.3bn 100 (55) (45) – (100) 2029 108.03 JPY 1.53% Cross currency interest rate swap – CNY investment CNY 458m (1) 4 (3) – 1 2026 6.68 CNY 4.80% Foreign currency borrowing – GBP investment GBP 350m 444 (288) 24 – (264) 2031 n/a GBP 5.75% Foreign currency borrowing – EUR investment7 EUR 800m 881 (102) 33 – (69) 2029 n/a EUR 0.38% Contingent consideration liabilities and Acerta Pharma share purchase liability – AZUK and AZAB USD investments USD 1,937m (1,937) 2,216 (81) – 2,135 – – – 1 Swaps designated in a fair value hedge matured on 24 November 2021 and hedge ineffectiveness during 2023 was $nil (2022: $nil; 2021: $nil). 2 Hedge ineffectiveness recognised on swaps designated in a cash flow hedge during the period was $nil (2022: $nil; 2021: $nil). 3 Hedge ineffectiveness recognised on swaps designated in a net investment hedge during the period was $nil (2022: $nil; 2021: $nil). 4 Fair value movements on cross-currency interest rate swaps in cash flow hedge and net investment hedge relationships are shown inclusive of the impact of costs of hedging. 5 Nominal amount of FX forwards in a cash flow hedge of $2,009m represents the USD equivalent notional of the FX forwards. By currency, the nominal amounts were SEK 9,778m at FX rate 9.9869, JPY 24,351m at 141.4050, GBP 428m at 0.7844 and EUR 228m at 0.9036. All FX forwards in a cash flow hedge mature on 25 January 2024. 6 The EUR 450m NIH matured in November 2021, when the hedging instrument, a EUR bond matured. 7 On 3 June 2021, upon issuance of the EUR 800m 0.375% 2029 Non-callable bond, EUR 550m was designated in a net investment hedge of the foreign currency exposure in relation of an equivalent amount of EUR-denominated net assets. The remaining EUR 250m was subsequently designated in a net investment hedge upon maturity of the EUR 450m bond on 24 November 2021. Key controls applied to transactions in derivative financial instruments are to use only instruments where good market liquidity exists, to revalue all financial instruments regularly using current market rates and to sell options only to offset previously purchased options or as part of a risk management strategy. The Group is not a net seller of options, and does not use derivative financial instruments for speculative purposes. The Group held no options during the reporting period. 29 Employee costs and share plans for employees Employee costs The monthly average number of people, to the nearest hundred, employed by the Group is set out in the table below. In accordance with the Companies Act 2006, this includes part-time employees. 2023 2022 2021 Employees UK 10,700 9,800 8,900 Rest of Europe 23,000 20,600 18,300 The Americas 22,400 20,900 18,800 Asia, Africa & Australasia 30,300 30,700 33,600 Continuing operations 86,400 82,000 79,600 Geographical distribution described in the table above is by location of legal entity employing staff. Certain staff will undertake some or all of their activity in a different location. The number of people employed by the Group at the end of 2023 was 89,900 (2022: 83,500; 2021: 83,100). The costs incurred during the year in respect of these employees were: 2023 2022 2021 $m $m $m Wages and salaries 9,341 8,656 7,633 Social security costs 1,100 991 886 Pension costs 537 546 564 Other employment costs 1,357 1,338 1,192 Total 12,335 11,531 10,275 Severance costs of $123m are not included above (2022: $227m; 2021: $238m). The charge for share-based payments in respect of share plans is $579m (2022: $619m; 2021: $615m). Payments made to the Employee Benefit Trust upon vesting of share awards are recognised within operating cash flows, reflecting the substance of the arrangement in place between the Group and the Trust. The plans are equity settled. The Directors believe that, together with the basic salary system, the Group’s employee incentive schemes provide competitive and market-related packages to motivate employees. They should also align the interests of employees with those of shareholders, as a whole, through long-term share ownership in the Company. The Group’s current US, UK and Swedish schemes are described below; other arrangements apply elsewhere. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 201 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 29 Employee costs and share plans for employees continued Bonus and share plans US In the US, there are two employee short-term performance bonus plans in operation to differentiate and reward strong individual performance. Performance bonuses are paid in cash. The AstraZeneca Performance Share Plan and the AstraZeneca Global Restricted Share Plan operate in respect of relevant employees in the US. AstraZeneca ADRs necessary to satisfy the awards are purchased on the market or funded via a trust. UK The AstraZeneca UK Performance Bonus Plan Employees of participating AstraZeneca UK companies are invited to participate in this bonus plan, which rewards strong individual performance. Bonuses are paid in cash. The AstraZeneca UK All-Employee Share Plan The Company offers UK employees the opportunity to buy Partnership Shares (Ordinary Shares). Employees may invest up to £150 a month to purchase Partnership Shares in the Company at the current market value. In 2010, the Company introduced a Matching Share element, the first award of which was made in 2011. Currently one Matching Share is awarded for every four Partnership Shares purchased. Partnership Shares and Matching Shares are held in the HM Revenue & Customs (HMRC)-approved All-Employee Share Plan. At the Company’s AGM in 2002, shareholders approved the issue of new shares for the purposes of the All-Employee Share Plan. Sweden In Sweden, an all-employee performance bonus plan is in operation, which rewards strong individual performance. Bonuses are paid 50% into a fund investing in AstraZeneca equities and 50% in cash. The AstraZeneca Executive Annual Bonus Scheme, the AstraZeneca Performance Share Plan and the AstraZeneca Global Restricted Stock Plan all operate in respect of relevant AstraZeneca employees in Sweden. Other bonus and share plans that operate across the Group are described below. The AstraZeneca Executive Annual Bonus Scheme This scheme is a performance bonus scheme for Directors and senior employees who do not participate in the AstraZeneca UK Performance Bonus Plan. Annual bonuses are paid in cash and reflect both corporate and individual performance measures. The Remuneration Committee has discretion to reduce or withhold bonuses if business performance falls sufficiently short of expectations in any year such as to make the payment of bonuses inappropriate. The AstraZeneca Deferred Bonus Plan This plan was introduced in 2006 and is used to defer a portion of the bonus earned under the AstraZeneca Executive Annual Bonus Scheme into Ordinary Shares in the Company for a period of three years. The plan currently operates only in respect of Executive Directors and members of the SET (with awards granted as AstraZeneca ADRs for members of SET employed within the US). Awards of shares under this plan are typically made in March each year, the first award having been made in February 2006. The AstraZeneca Performance Share Plan This plan was approved by shareholders in 2020 for a period of 10 years (subsequently amended by approval of shareholders in 2021) and replaces the 2014 AstraZeneca Performance Share Plan. Generally, awards can be granted at any time, but not during a closed period of the Company. The first grant of Performance Share Plan awards was made in May 2014 under the 2014 AstraZeneca Performance Share Plan. Awards granted under the plan vest after three years, or in the case of Executive Directors and members of the SET, after an additional two-year holding period, and is subject to the achievement of performance conditions. For awards granted to all participants in 2023, vesting is subject to a combination of measures focused on science and innovation, revenue growth, financial performance and carbon reduction. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated, including agreeing performance targets and which employees should be eligible to participate. The AstraZeneca Investment Plan This plan was introduced in 2010 and approved by shareholders at the 2010 AGM. The final grant of awards under this plan took place in March 2016. Awards granted under the plan vest after eight years and are subject to performance conditions measured over a period of four years. The AstraZeneca Global Restricted Stock Plan The Global Restricted Stock Plan (GRSP) was introduced in 2010. This plan provides for the grant of restricted stock unit (RSU) awards to selected below SET-level employees and is used in conjunction with the AstraZeneca Performance Share Plan to provide a mix of RSUs and performance share units (PSUs). Awards typically vest on the third anniversary of the date of grant and are contingent on continued employment with the Company. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated. The AstraZeneca Restricted Share Plan This plan was introduced in 2008 and provides for the grant of restricted share unit (RSU) awards to key employees, excluding Executive Directors. Awards are made on an ad hoc basis with variable vesting dates. The plan has been used five times in 2023 to make awards to 305 employees. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated. 202 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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The AstraZeneca Extended Incentive Plan This plan was introduced in 2018 and provides for the grant of awards to key employees, excluding Executive Directors. Awards are made on an ad hoc basis and 50% of the award will normally vest on the fifth anniversary of grant, with the balance vesting on the tenth anniversary of grant. The award can be subject to the achievement of performance conditions. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated, including agreeing performance targets (if any) and which employees should be invited to participate. Details of share options outstanding during the year for the main share plans are shown below. The AstraZeneca Performance Share Plan The AstraZeneca Global Restricted Stock Plan The AstraZeneca Restricted Share Plan The AstraZeneca Extended Incentive Plan Ordinary Shares ADR Shares Ordinary Shares ADR Shares1 Ordinary Shares ADR Shares Ordinary Shares ADR Shares ‘000 ‘000 ‘000 ‘000 ‘000 ‘000 ‘000 ‘000 Outstanding at 1 January 2021 3,045 4,791 1,626 9,175 161 506 300 65 Granted 1,275 2,082 902 4,509 139 481 – 175 Forfeited (220) (494) (158) (1,254) (18) (42) (18) (45) Cancelled (9) – (1) (8) – – – – Exercised (632) (1,201) (341) (2,881) (27) (182) – – Outstanding at 31 December 2021 3,459 5,178 2,028 9,541 255 763 282 195 Granted 1,059 2,339 1,237 6,478 75 216 – – Forfeited (132) (570) (190) (1,627) (25) (136) (23) – Cancelled – – – (3) – – – – Exercised (756) (1,223) (606) (2,706) (72) (165) – – Outstanding at 31 December 2022 3,630 5,724 2,469 11,683 233 678 259 195 Granted 976 2,071 1,185 6,343 208 436 71 95 Forfeited (148) (437) (187) (1,417) (20) (59) (8) – Cancelled – – – (3) – – – (34) Exercised (813) (1,470) (570) (2,738) (86) (288) (107) (9) Outstanding at 31 December 2023 3,645 5,888 2,897 13,868 335 767 215 247 1 Shares issued to Alexion employees under the GRSP are covered under the Alexion employee share award below. The AstraZeneca Performance Share Plan The AstraZeneca Global Restricted Stock Plan The AstraZeneca Restricted Share Plan The AstraZeneca Extended Incentive Plan WAFV1 WAFV WAFV WAFV WAFV WAFV WAFV WAFV pence $ pence $ pence $ pence $ WAFV of 2021 grants 6012 41.56 6893 47.75 7415 53.96 – 56.83 WAFV of 2022 grants 8328 55.73 9167 61.21 9894 63.35 – – WAFV of 2023 grants 9929 59.95 10822 65.38 11135 65.37 11748 74.78 1 Weighted average fair value. Alexion employee share award plan At acquisition in 2021 Alexion employee share awards were converted into AstraZeneca restricted stock awards that continue to have, and shall be subject to, the same terms and conditions as applied in the corresponding Alexion awards immediately prior to completion. The fair value at the grant date was $57.54 and of the 15,220,000 shares outstanding at 31 December 2021, 8,627,000 were exercised and 980,000 were forfeited during 2022. During 2022, Alexion employees had the option to defer awards due to vest in July 2022 until February 2023 when they would also receive an additional vest equivalent to 15% of the shares deferred. As a result, 1,780,000 shares were deferred, resulting in an additional 267,000 shares being issued with a grant date fair value of $65.62, that vested in 2023. During 2023, 2,060,000 shares vested, 531,000 were forfeited/cancelled and the closing balance of these awards as of 31 December 2023 was 3,022,000. The weighted average fair value for awards granted under the AstraZeneca Performance Share Plan is primarily based on the market price at the point of grant adjusted for the market-based performance elements which are valued using a modified version of the Monte Carlo method. The fair values of all other plans are set using the market price at the point of award. These awards are settled in equity including dividends accumulated from the date of award to vesting. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 203 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 30 Commitments, contingent liabilities and contingent assets 2023 2022 2021 Commitments $m $m $m Contracts placed for future capital expenditure on Property, plant and equipment and software development costs not provided for in these financial statements 1,368 502 388 Guarantees and contingencies arising in the ordinary course of business, for which no security has been given, are not expected to result in any material financial loss. Research and development collaboration payments The Group has various ongoing collaborations, including in-licensing and similar arrangements with development partners. Such collaborations may require the Group to make payments on achievement of stages of development, launch or revenue milestones, although the Group generally has the right to terminate these agreements at no cost. The Group recognises research and development milestones as an intangible asset once it is committed to payment, which is generally when the Group reaches set trigger points in the development cycle. Revenue-related milestones are recognised as intangible assets on product launch at a value based on the Group’s long-term revenue forecasts for the related product. The table below indicates potential development and revenue-related payments that the Group may be required to make under such collaborations. Years 5 Total Under 1 year Years 1 and 2 Years 3 and 4 and greater $m $m $m $m $m Future potential research and development milestone payments 10,971 1,256 3,798 1,764 4,153 Future potential revenue milestone payments 20,195 43 491 2,400 17,261 The table includes all potential payments for achievement of milestones under ongoing research and development arrangements. Revenue-related milestone payments represent the maximum possible amount payable on achievement of specified levels of revenue as set out in individual contract agreements, but exclude variable payments that are based on unit sales (e.g. royalty-type payments) which are expensed as the associated sale is recognised. The table excludes any payments already capitalised in the Financial Statements for the year ended 31 December 2023 which have been capitalised with reference to the latest Group sales forecasts for approved indications. The future payments we disclose represent contracted payments and, as such, are not discounted and are not risk-adjusted. As detailed in the Risk section from page 54, the development of any pharmaceutical product candidate is a complex and risky process that may fail at any stage in the development process due to a number of factors (including items such as failure to obtain regulatory approval, unfavourable data from key studies, adverse reactions to the product candidate or indications of other safety concerns). The timing of the payments is based on the Group’s current best estimate of achievement of the relevant milestone. Environmental costs and liabilities The Group’s expenditure on environmental protection, including both capital and revenue items, relates to costs that are necessary for implementing internal systems and programmes, and meeting legal and regulatory requirements for processes and products. This includes investment to conserve natural resources and otherwise minimise the impact of our activities on the environment. They are an integral part of normal ongoing expenditure for carrying out the Group’s research, manufacturing and commercial operations and are not separated from overall operating and development costs. There are no known changes in legal, regulatory or other requirements resulting in material changes to the levels of expenditure for 2021, 2022 or 2023. In addition to expenditure for meeting current and foreseen environmental protection requirements, the Group incurs costs in investigating and cleaning up legacy land and groundwater contamination. In particular, AstraZeneca has environmental liabilities at some currently or formerly owned, leased and third-party sites. In the US, Zeneca Inc., and/or its indemnitees, have been named as potentially responsible parties (PRPs) or defendants at a number of sites where Zeneca Inc. is likely to incur future environmental investigation, remediation, operation and maintenance costs under federal, state, statutory or common law environmental liability allocation schemes (together, US Environmental Consequences). Similarly, Stauffer Management Company LLC (SMC), which was established in 1987 to own and manage certain assets of Stauffer Chemical Company acquired that year, and/or its indemnitees, have been named as PRPs or defendants at a number of sites where SMC is likely to incur US Environmental Consequences. AstraZeneca has also given indemnities to third parties for a number of sites outside the US. These environmental liabilities arise from legacy operations that are not currently part of the Group’s business and, at most of these sites, remediation, where required, is either completed or in progress. AstraZeneca has made provisions for the estimated costs of future environmental investigation, remediation, operation and maintenance activity beyond normal ongoing expenditure for maintaining the Group’s R&D and manufacturing capacity and product ranges, where a present obligation exists, it is probable that such costs will be incurred and they can be estimated reliably. With respect to such estimated future costs, there were provisions at 31 December 2023 in the aggregate of $112m (2022: $131m; 2021: $90m), mainly relating to the US. Where we are jointly liable or otherwise have cost-sharing agreements with third parties, we reflect only our share of the obligation. Where the liability is insured in part or in whole by insurance or other arrangements for reimbursement, an asset is recognised to the extent that this recovery is virtually certain. It is possible that AstraZeneca could incur future environmental costs beyond the extent of our current provisions. The extent of such possible additional costs is inherently difficult to estimate due to a number of factors, including: (1) the nature and extent of claims that may be asserted in the future; (2) whether AstraZeneca has or will have any legal obligation with respect to asserted or unasserted claims; (3) the type of remedial action, if any, that may be selected at sites where the remedy is presently not known; (4) the potential for recoveries from or allocation of liability to third parties; and (5) the length of time that the environmental investigation, remediation and liability allocation process can take. As per our accounting policy on page 158, Provisions for these costs are made when there is a present obligation and where it is probable that expenditure on remedial work will be required and a reliable estimate can be made of the cost. Notwithstanding and subject to the foregoing, we estimate the potential additional loss for future environmental investigation, remediation, remedial operation and maintenance activity above and beyond our provisions to be, in aggregate, between $114m and $191m (2022: $113m and $188m; 2021: $99m and $165m) which relates mainly to the US. 204 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Legal proceedings AstraZeneca is involved in various legal proceedings considered typical to its business, including actual or threatened litigation and actual or potential government investigations relating to employment matters, product liability, commercial disputes, pricing, sales and marketing practices, infringement of IP rights, and the validity of certain patents and competition laws. The more significant matters are discussed below. Most of the claims involve highly complex issues. Often these issues are subject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or an estimate of the amount of any loss is difficult to ascertain. We do not believe that disclosure of the amounts sought by plaintiffs, if known, would be meaningful with respect to these legal proceedings. This is due to a number of factors, including (i) the stage of the proceedings (in many cases trial dates have not been set) and the overall length and extent of pre-trial discovery; (ii) the entitlement of the parties to an action to appeal a decision; (iii) clarity as to theories of liability, damages and governing law; (iv) uncertainties in timing of litigation; and (v) the possible need for further legal proceedings to establish the appropriate amount of damages, if any. While there can be no assurance regarding the outcome of any of the legal proceedings referred to in this Note 30, based on management’s current and considered view of each situation, we do not currently expect them to have a material adverse effect on our financial position including within the next financial year. This position could of course change over time, not least because of the factors referred to above. In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal (or other similar forms of relief), or where a loss is probable and we are able to make a reasonable estimate of the loss, we generally indicate the loss absorbed or make a provision for our best estimate of the expected loss. Where it is considered that the Group is more likely than not to prevail, legal costs involved in defending the claim are charged to profit as they are incurred. Where it is considered that the Group has a valid contract which provides the right to reimbursement (from insurance or otherwise) of legal costs and/or all or part of any loss incurred or for which a provision has been established, and we consider recovery to be virtually certain, the best estimate of the amount expected to be received is recognised as an asset. Assessments as to whether or not to recognise provisions or assets, and of the amounts concerned, usually involve a series of complex judgements about future events and can rely heavily on estimates and assumptions. AstraZeneca believes that the provisions recorded are adequate based on currently available information and that the insurance recoveries recorded will be received. However, given the inherent uncertainties involved in assessing the outcomes of these cases, and in estimating the amount of the potential losses and the associated insurance recoveries, we could in the future incur judgments or insurance settlements that could have a material adverse effect on our results in any particular period. IP claims include challenges to the Group’s patents on various products or processes and assertions of non-infringement of patents. A loss in any of these cases could result in loss of patent protection on the related product. The consequences of any such loss could be a significant decrease in Product Sales, which could have a material adverse effect on our results. The lawsuits filed by AstraZeneca for patent infringement against companies that have filed abbreviated new drug applications (ANDAs) in the US, seeking to market generic forms of products sold by the Group prior to the expiry of the applicable patents covering these products, typically also involve allegations of non-infringement, invalidity and unenforceability of these patents by the ANDA filers. In the event that the Group is unsuccessful in these actions or the statutory 30-month stay expires before a ruling is obtained, the ANDA filers involved will also have the ability, subject to FDA approval, to introduce generic versions of the product concerned. AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP. Over the course of the past several years, including in 2023, a significant number of commercial litigation claims in which AstraZeneca is involved have been resolved, particularly in the US, thereby reducing potential contingent liability exposure arising from such litigation. Similarly, in part due to patent litigation and settlement developments, greater certainty has been achieved regarding possible generic entry dates with respect to some of our patented products. At the same time, like other companies in the pharmaceutical sector and other industries, AstraZeneca continues to be subject to government investigations around the world. Patent litigation Legal proceedings brought against AstraZeneca for which a provision has been taken Imfinzi and Imjudo US and ROW patent proceedings In February 2022, in Japan, Ono Pharmaceuticals filed a lawsuit in Tokyo District Court, Civil Division against AstraZeneca alleging that AstraZeneca’s marketing of Imfinzi in Japan infringed several of their patents. In March 2022, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC filed a lawsuit in the US District Court for the District of Delaware (District Court) against AstraZeneca alleging that AstraZeneca’s marketing of Imfinzi infringed several of their patents. In April 2023, Bristol-Myers Squibb Co., E.R. Squibb & Sons, LLC, Tasuku Honjo, Ono Pharmaceutical Co., Ltd., and the Dana-Farber Cancer Institute Inc. filed a separate lawsuit in the District Court against AstraZeneca alleging that AstraZeneca’s marketing of Imfinzi infringed another of their patents. In January 2023, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC filed a lawsuit in the District Court against AstraZeneca alleging that AstraZeneca’s marketing of Imjudo infringed two of their patents. In July 2023, AstraZeneca entered into a global settlement agreement with Bristol-Myers Squibb Co., E.R. Squibb & Sons, LLC, and Ono Pharmaceutical Co., Ltd. that resolves all patent disputes between the companies relating to Imfinzi and Imjudo. In June 2023, a provision was taken totaling $510m. These matters are now concluded. Legal proceedings brought against AstraZeneca considered to be contingent liabilities Enhertu US patent proceedings In October 2020, Seagen Inc. (Seagen) filed a complaint against Daiichi Sankyo Company, Limited (Daiichi Sankyo) in the US District Court for the Eastern District of Texas (District Court) alleging that Enhertu infringes a Seagen patent. AstraZeneca co-commercialises Enhertu with Daiichi Sankyo, Inc. in the US. After trial in April 2022, the jury found that the patent was infringed and awarded Seagen $41.82m in past damages. In July 2022, the District Court entered final judgment and declined to enhance damages on the basis of wilfulness. In October 2023, the District Court entered an amended final judgment that requires Daiichi Sankyo to pay Seagen a royalty of 8% on US sales of Enhertu from April 1, 2022, through November 4, 2024, in addition to the past damages previously awarded by the Court. AstraZeneca and Daiichi Sankyo have appealed the District Court’s decision. In December 2020 and January 2021, AstraZeneca and Daiichi Sankyo, Inc. filed post-grant review (PGR) petitions with the US Patent and Trademark Office (USPTO) alleging, inter alia, that the Seagen patent is invalid for lack of written description and enablement. The USPTO initially declined to institute the PGRs, but, in April 2022, the USPTO granted the rehearing requests, instituting both PGR petitions. Seagen subsequently disclaimed all patent claims at issue in one of the PGR proceedings. In July 2022, the USPTO reversed its institution decision and declined to institute the other PGR petition. AstraZeneca and Daiichi Sankyo, Inc. requested reconsideration of the decision not to institute review of the patent. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 205 Strategic Report Corporate Governance Financial Statements Additional Information |
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30 Commitments, contingent liabilities and contingent assets continued Notes to the Group Financial Statements continued In February 2023, the USPTO reinstituted the PGR proceeding. An oral hearing took place in August 2023. In January 2024, the USPTO issued a decision that Seagen’s patent is unpatentable, invalidating all claims asserted against Enhertu. The USPTO’s decision does not overturn the Texas District Court’s decision unless and until the USPTO’s decision is affirmed on appeal by the US Court of Appeals for the Federal Circuit. No such appeal has been filed. Faslodex Patent proceedings outside the US In 2021 in Japan, AstraZeneca received notice from the Japan Patent Office (JPO) that Sandoz K.K. (Sandoz) and Sun Pharma Japan Ltd. (Sun) were seeking to invalidate the Faslodex formulation patent. AstraZeneca defended the challenged patent, and Sun withdrew from the JPO patent challenge. In July 2023, the JPO issued a final decision upholding various claims of the challenged patent and determining that other patent claims were invalid. In August 2023, Sandoz appealed the JPO decision to the Japan IP High Court. Tagrisso US patent proceedings In September 2021, Puma Biotechnology, Inc. and Wyeth LLC filed a patent infringement lawsuit in the US District Court for the District of Delaware against AstraZeneca relating to Tagrisso. Trial has been scheduled for May 2024. Legal proceedings brought by AstraZeneca considered to be contingent assets Brilinta US patent proceedings In 2015 and subsequently, in response to Paragraph IV notices from ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of Delaware (District Court) relating to patents listed in the FDA Orange Book with reference to Brilinta. In 2022, AstraZeneca entered into several separate settlements and the District Court entered consent judgments to dismiss each of the corresponding litigations. Additional proceedings are ongoing in the District Court. No trial date has been set. Calquence US patent proceedings In February 2022, in response to Paragraph IV notices from multiple ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of Delaware. In its complaint, AstraZeneca alleges that a generic version of Calquence, if approved and marketed, would infringe patents listed in the FDA Orange Book with reference to Calquence that are owned or licensed by AstraZeneca. Trial has been scheduled for March 2025. In February 2023, Sandoz Inc. filed a petition for inter partes review with the US Patent and Trademark Office of certain Calquence patent claims. AstraZeneca has asserted claims for patent infringement against Sandoz and other defendants in the US ANDA litigation. In August 2023, the US Patent Trial and Appeal Board issued a decision denying institution of inter partes review. Daliresp US patent proceedings In 2015 and subsequently, in response to Paragraph IV notices from ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of New Jersey (District Court) relating to patents listed in the FDA Orange Book with reference to Daliresp. In 2022, AstraZeneca entered into a settlement agreement and the District Court entered a consent judgment to dismiss the corresponding litigation. Additional ANDA challenges are pending. Farxiga US patent proceedings In May 2021, AstraZeneca proceeded to trial against ANDA filer Zydus Pharmaceuticals (USA) Inc. (Zydus) in the US District Court for the District of Delaware (District Court). In October 2021, the District Court issued a decision finding the asserted claims of AstraZeneca’s patent as valid and infringed by Zydus’s ANDA product. In August 2022, Zydus appealed the District Court decision. Zydus’s appeal has been dismissed. In December 2023, AstraZeneca initiated ANDA litigation against Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. in the District Court. No trial date has been set. Lokelma US patent proceedings In August 2022, in response to Paragraph IV notices, AstraZeneca initiated ANDA litigation against multiple generic filers in the US District Court for the District of Delaware. Trial has been scheduled for March 2025. Lynparza US patent proceedings In December 2022, AstraZeneca received a Paragraph IV notice from an ANDA filer relating to patents listed in the FDA Orange Book with reference to Lynparza. In February 2023, in response to the Paragraph IV notice, AstraZeneca, MSD International Business GmbH, and the University of Sheffield initiated ANDA litigation against Natco Pharma Limited (Natco) in the US District Court for the District of New Jersey. In the complaint, AstraZeneca alleged that Natco’s generic version of Lynparza, if approved and marketed, would infringe patents listed in the FDA Orange Book with reference to Lynparza. No trial date has been scheduled. In December 2023, AstraZeneca received a Paragraph IV notice from an ANDA filer relating to patents listed in the FDA Orange Book with reference to Lynparza. In February 2024, in response to the Paragraph IV notice, AstraZeneca, MSD International Business GmbH, and the University of Sheffield initiated ANDA litigation against Sandoz Inc. (Sandoz) in the US District Court for the District of New Jersey. In the complaint, AstraZeneca alleged that Sandoz’s generic version of Lynparza, if approved and marketed, would infringe patents listed in the FDA Orange Book with reference to Lynparza. No trial date has been scheduled. Soliris US patent proceedings In January 2024, Alexion initiated patent infringement litigation against Samsung Bioepis Co. Ltd. in the US District Court for the District of Delaware alleging that Samsung’s biosimilar eculizumab product, for which Samsung is currently seeking FDA approval, will infringe six Soliris-related patents. No trial date has been scheduled. Five of the six asserted patents are also the subject of inter partes review proceedings before the US Patent and Trademark Office. Tagrisso Patent proceedings outside the US In Russia, in August 2023, AstraZeneca filed lawsuits in the Arbitration Court of the Moscow Region (Court) against the Ministry of Health of the Russian Federation and Axelpharm LLC related to Axelpharm’s improper use of AstraZeneca’s information to obtain authorisation to market a generic version of Tagrisso. In December 2023, the Court dismissed the lawsuit against the Ministry of Health of the Russian Federation. In January 2024, AstraZeneca filed an appeal, which is pending. The lawsuit against Axelpharm remains pending before the Court. In Russia, in November 2023, Axelpharm LLC filed a compulsory licensing action against AstraZeneca in the Arbitration Court of the Moscow Region (Court) related to a patent that covers Tagrisso. The lawsuit remains pending before the Court. Legal proceedings brought against AstraZeneca which have been concluded Movantik US patent proceedings AstraZeneca has resolved by settlement agreement the previously disclosed patent infringement lawsuit brought by Aether Therapeutics, Inc. in the US District Court for the District of Delaware against AstraZeneca, Nektar Therapeutics and Daiichi Sankyo, Inc., relating to Movantik. This matter is now concluded. Legal proceedings brought by AstraZeneca which have been concluded Symbicort US patent proceedings In February 2023, AstraZeneca resolved by settlement agreement the previously disclosed ANDA litigations with Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P. (together, defendants). In those actions, AstraZeneca alleged that the defendants’ generic versions of Symbicort, 206 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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if approved and marketed, would infringe various AstraZeneca patents. This matter is now concluded. Tagrisso Patent proceedings outside the US In Russia, in October 2021, AstraZeneca filed a lawsuit in the Arbitration Court of the Moscow Region (Court) against Axelpharm, LLC to prevent it from obtaining authorisation to market a generic version of Tagrisso prior to the expiration of AstraZeneca’s patents covering Tagrisso. The lawsuit also names the Ministry of Health of the Russian Federation as a third party. In March 2022, the Court dismissed the lawsuit. In June 2022, the dismissal was affirmed on appeal. In January 2023, the dismissal was affirmed on further appeal. This matter is now concluded. Product liability litigation Legal proceedings brought against AstraZeneca for which a provision has been taken Nexium and Losec/Prilosec US proceedings AstraZeneca has been defending lawsuits brought in federal and state courts involving claims that plaintiffs have been diagnosed with various injuries following treatment with proton pump inhibitors (PPIs), including Nexium and Prilosec. Most of the lawsuits alleged kidney injury. In August 2017, the pending federal court cases were consolidated in a multidistrict litigation (MDL) proceeding in the US District Court for the District of New Jersey for pre-trial purposes. In addition to the MDL cases, there were cases alleging kidney injury filed in Delaware and New Jersey state courts. In addition, AstraZeneca has been defending lawsuits involving allegations of gastric cancer following treatment with PPIs, including one such claim in the US District Court for the Middle District of Louisiana (Louisiana District Court). In October 2023, AstraZeneca resolved all pending claims in the MDL, as well as all pending claims in Delaware and New Jersey state courts, for $425m, for which a provision has been taken. The only remaining case is the one pending in the Louisiana District Court. The Court in that case has postponed trial, which was previously scheduled to begin in April 2024. No new trial date has been set. Legal proceedings brought against AstraZeneca considered to be contingent liabilities Farxiga and Xigduo XR US proceedings AstraZeneca has been named as a defendant in lawsuits involving plaintiffs claiming physical injury, including Fournier’s Gangrene and necrotising fasciitis, from treatment with Farxiga and/or Xigduo XR. In September 2023, the parties resolved by settlement agreement one case, filed in state court in Minnesota, previously scheduled for trial in October 2023. All remaining claims are filed in Delaware state court and remain pending. Nexium and Losec/Prilosec Canada proceedings In Canada, in July and August 2017, AstraZeneca was served with three putative class action lawsuits. Two of the lawsuits have been dismissed, one in 2019 and one in 2021. The third lawsuit seeks authorisation to represent individual residents in Canada who allegedly suffered kidney injuries from the use of proton pump inhibitors, including Nexium and Losec. Onglyza and Kombiglyze US proceedings In the US, AstraZeneca is defending various lawsuits alleging heart failure, cardiac injuries, and/or death from treatment with Onglyza or Kombiglyze. In August 2022, the US District Court for the Eastern District of Kentucky, presiding over the consolidated federal cases, granted AstraZeneca’s motion for summary judgment, which plaintiffs have appealed to the US Court of Appeals for the Sixth Circuit. In the California state court proceeding, the trial court granted summary judgment for AstraZeneca, which the California appellate court affirmed. The California Supreme Court has declined further review, so the California state court proceeding has concluded. Commercial litigation Legal proceedings brought against AstraZeneca considered to be contingent liabilities 340B Antitrust Litigation US proceedings In September 2021, AstraZeneca was served with a class-action antitrust complaint filed in the US District Court for the Western District of New York (District Court) by Mosaic Health alleging a conspiracy to restrict access to 340B discounts in the diabetes market through contract pharmacies. In September 2022, the District Court granted AstraZeneca’s motion to dismiss the Complaint. In February 2024, the District Court denied Plaintiffs’ request to file a new amended complaint and entered an order closing the matter. Anti-Terrorism Act Civil Lawsuit US proceedings In the US, in October 2017, AstraZeneca and certain other pharmaceutical and/or medical device companies were named as defendants in a complaint filed in the US District Court for the District of Columbia (District Court) by US nationals (or their estates, survivors, or heirs) who were killed or wounded in Iraq between 2005 and 2013. The plaintiffs allege that the defendants violated the US Anti-Terrorism Act and various state laws by selling pharmaceuticals and medical supplies to the Iraqi Ministry of Health. In July 2020, the District Court granted AstraZeneca’s and the other defendants’ motion to dismiss the lawsuit, which the DC Circuit Court of Appeals (the Appellate Court) reversed in January 2022. In February 2023, the Appellate Court denied a request for en banc review. In June 2023, AstraZeneca and the other defendants filed a petition for review by the United States Supreme Court. Caelum Trade Secrets Litigation US proceedings AstraZeneca has been defending a matter filed by the University of Tennessee Research Foundation in the US District Court for the Eastern District of Tennessee (District Court) related to CAEL-101. In October 2023, AstraZeneca filed a motion for summary judgment on all claims and awaits a decision by the District Court. Trial is currently scheduled for September 2024. Definiens Germany proceedings In Germany, in July 2020, AstraZeneca received a notice of arbitration filed with the German Institution of Arbitration from the sellers of Definiens AG (the Sellers) regarding the 2014 Share Purchase Agreement (SPA) between AstraZeneca and the Sellers. The Sellers claim that they are owed approximately $140m in earn-outs under the SPA. The arbitration hearing took place in March 2023 and final post-hearing written briefs were submitted in June 2023. In December 2023, the arbitration panel made a final award of $46.43m in favour of the Sellers. AstraZeneca is considering its options. Employment Litigation US proceedings In December 2022, AstraZeneca was served with a lawsuit filed by seven former employees in the US District Court for the District of Delaware (District Court) asserting age, religion, and disability discrimination claims related to AstraZeneca’s vaccination requirement. In March 2023, AstraZeneca filed a motion to dismiss the religious and disability discrimination claims and a motion to strike the class and collective claims. That motion is fully briefed and the parties are awaiting a decision by the District Court. Pay Equity Litigation US proceedings AstraZeneca was defending a putative class and collective action matter in the US District Court for the Northern District of Illinois (District Court) brought by three named plaintiffs, who are former AstraZeneca employees. The case involved claims under the federal and Illinois Equal Pay Acts, with the plaintiffs alleging they were paid less than male employees who performed substantially similar and/or equal work. In January 2023, the District Court granted AstraZeneca’s motion to dismiss plaintiffs’ complaint. In March 2023, plaintiffs filed a Second Amended Complaint. AstraZeneca moved to dismiss the Second Amended Complaint in April 2023. The motion to dismiss was denied in October 2023, and the parties are proceeding with discovery. Seroquel XR (Antitrust Litigation) US proceedings In 2019, AstraZeneca was named in several related complaints brought in the US District Court for the Southern District of New York (District Court), including several putative class action lawsuits that were purportedly brought on behalf of classes of direct Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 207 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Group Financial Statements continued 30 Commitments, contingent liabilities and contingent assets continued purchasers or end payors of Seroquel XR, that allege AstraZeneca and generic drug manufacturers violated US antitrust laws when settling patent litigation related to Seroquel XR. In July 2022, in response to AstraZeneca’s motion to dismiss, the District Court dismissed all claims relating to the settlement with one of the generic manufacturers but denied the motion with respect to all claims relating to the second generic manufacturer and allowed those claims to proceed. Trial is currently scheduled for May 2025. Syntimmune US proceedings In connection with Alexion’s prior acquisition of Syntimmune, Inc., (Syntimmune) in December 2020, Alexion was served with a lawsuit filed by the stockholders’ representative for Syntimmune in Delaware state court that alleged, among other things, breaches of contractual obligations relating to the 2018 merger agreement. The stockholders’ representative alleges that Alexion failed to meet its obligations under the merger agreement to use commercially reasonable efforts to achieve the milestones. Alexion also filed a claim for breach of the representations in the 2018 merger agreement. A trial was held in July 2023 and a decision is expected in 2024. Viela Bio, Inc. Shareholder Litigation US proceedings In February 2023, AstraZeneca was served with a lawsuit filed in Delaware state court against AstraZeneca and certain officers (collectively, defendants), on behalf of a putative class of Viela Bio, Inc. (Viela) shareholders. The complaint alleges that defendants breached their fiduciary duty to Viela shareholders in the course of Viela’s 2021 merger with Horizon Therapeutics, plc. In May 2023, AstraZeneca filed a motion to dismiss, which is now fully briefed and pending before the Court. Legal proceedings brought by AstraZeneca considered to be contingent assets PARP Inhibitor Royalty Dispute UK proceedings In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, (GSK)) entered into two worldwide, royalty-bearing patent license agreements with AstraZeneca related to GSK’s product niraparib. In May 2021, AstraZeneca filed a lawsuit against GSK in the Commercial Court of England and Wales alleging that GSK has failed to pay all of the royalties due on niraparib sales under the license agreements. The case was transferred to the Chancery Division and a trial took place in March 2023. In April 2023, the court issued a decision in AstraZeneca’s favour. GSK has been granted permission to appeal, and the appellate hearing was held in January 2024. Legal proceedings brought against AstraZeneca which have been concluded Alexion Shareholder Litigation US proceedings In December 2016, putative securities class action lawsuits were filed in the US District Court for the District of Connecticut (District Court) against Alexion and certain officers and directors (collectively, defendants), on behalf of purchasers of Alexion publicly traded securities during the period 30 January 2014 through 26 May 2017. The amended complaint alleged that defendants engaged in securities fraud, including by making misrepresentations and omissions in their public disclosures concerning Alexion’s Soliris sales practices, management changes, and related investigations. In August 2021, the District Court issued a decision denying in part defendants’ motion to dismiss the matter. The Court granted plaintiffs’ motion for class certification in April 2023. In August 2023, the parties reached a settlement in principle of this matter. In September 2023, the court granted preliminary approval of the class settlement. A provision was taken in September 2023. The court granted final approval of the class settlement in December 2023, and the matter is now concluded. AZD1222 Securities Litigation US proceedings In January 2021, putative securities class action lawsuits were filed in the US District Court for the Southern District of New York (District Court) against AstraZeneca PLC and certain officers, on behalf of purchasers of AstraZeneca publicly traded securities during a period later amended to cover 15 June 2020 through 29 January 2021. The Amended Complaint alleges that defendants made materially false and misleading statements in connection with the development of AZD1222, AstraZeneca’s vaccine for the prevention of COVID-19. In September 2022, the District Court granted AstraZeneca’s motion to dismiss the Amended Complaint with prejudice. In May 2023, the US Court of Appeals for the Second Circuit affirmed the dismissal. The matter is now concluded. Portola Shareholder Litigation US proceedings In connection with Alexion’s July 2020 acquisition of Portola Pharmaceuticals, Inc. (Portola), Alexion assumed litigation to which Portola is a party. In January 2020, putative securities class action lawsuits were filed in the US District Court for the Northern District of California against Portola and certain officers and directors (collectively, defendants), on behalf of purchasers of Portola publicly traded securities during the period 8 January 2019 through 26 February 2020. The operative complaints alleged that defendants made materially false and/or misleading statements or omissions with regard to Andexxa. In June 2022, the parties reached a settlement in principle of this matter. In March 2023, the court granted final approval of the settlement. The matter is now concluded. Government investigations/proceedings Legal proceedings brought against AstraZeneca considered to be contingent liabilities 340B Qui Tam US proceedings In July 2023, AstraZeneca was served with an unsealed civil lawsuit brought by a qui tam relator on behalf of the United States, several states, and the District of Columbia in the US District Court for the Central District of California. The complaint alleges that AstraZeneca violated the US False Claims Act (FCA) and state-law analogues. In September 2023, AstraZeneca filed a motion to dismiss the relator’s claims. In response, the relator filed a First Amended Complaint. In December 2023, AstraZeneca filed a motion to dismiss the First Amended Complaint. 340B Administrative Proceedings US proceedings In September 2023, the Arkansas Insurance Department sent AstraZeneca an administrative complaint concerning compliance with Arkansas’s 340B Statute, which requires manufacturers to recognize an unlimited number of contract pharmacies. Previously disclosed Administrative Dispute Resolution proceedings against AstraZeneca remain pending before the US Health Resources and Services Administration. Brazilian Tax Assessment Matter Brazil proceedings In connection with an ongoing matter, in August 2019, the Brazilian Federal Revenue Service provided a Notice of Tax and Description of the Facts (the Tax Assessment) to two Alexion subsidiaries (the Brazil Subsidiaries), as well as to two additional entities – a logistics provider utilised by Alexion and a distributor. The Tax Assessment focuses on the importation of Soliris vials pursuant to Alexion’s free drug supply to patients programme in Brazil. Alexion prevailed in the first level of administrative appeals in the Brazilian federal administrative proceeding system based on a deficiency in the Brazil Tax Assessment. The decision was subject to an automatic (ex officio) appeal to the second level of the administrative courts. In March 2023, the second level of the administrative courts issued a decision to remand the matter to the first level of administrative courts for a determination on the merits. Texas Qui Tam US proceedings In December 2022, AstraZeneca was served with an unsealed civil lawsuit brought by qui tam relators on behalf of the State of Texas in Texas state court, which alleges that AstraZeneca engaged in unlawful marketing practices. In March 2023, AstraZeneca filed a motion to dismiss and a motion to transfer venue. In response, relators filed an Amended Petition. In May 2023, AstraZeneca filed a motion to 208 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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dismiss the Amended Petition and renewed its motion to transfer venue. In September 2023, the Texas state court denied AstraZeneca’s motion to transfer venue and motion to dismiss. Trial is currently scheduled for October 2024. Turkish Ministry of Health Matter Turkey proceedings In Turkey, in July 2020, the Turkish Ministry of Health (Ministry of Health) initiated an investigation regarding payments to healthcare providers by Alexion Turkey and former employees and consultants. The investigation arose from Alexion’s disclosure of a $21.5m civil settlement with the US Securities & Exchange Commission (SEC) in July 2020 fully resolving the SEC’s investigation into possible violations of the US Foreign Corrupt Practices Act. In September 2021, the Ministry of Health completed its draft investigation report, and referred the matter to the Ankara Public Prosecutor’s Office with a recommendation for further proceedings against certain former employees. US Congressional Inquiry US proceedings In January 2024, AstraZeneca received a letter from the US Senate Committee on Health, Education, Labor and Pensions (HELP Committee) seeking information related to AstraZeneca’s inhaled Respiratory products. AstraZeneca intends to cooperate with the inquiry. Vermont US Attorney Investigation US proceedings In April 2020, AstraZeneca received a Civil Investigative Demand from the US Attorney’s Office in Vermont and the Department of Justice, Civil Division, seeking documents and information relating to AstraZeneca’s relationships with electronic health-record vendors. AstraZeneca continues to cooperate with this enquiry. Legal proceedings brought by AstraZeneca considered to be contingent assets Inflation Reduction Act Litigation US proceedings In August 2023, AstraZeneca filed a lawsuit in federal court in Delaware challenging aspects of the drug price negotiation provisions of the Inflation Reduction Act and the implementing guidance and regulations promulgated by the US Department of Health and Human Services. Louisiana 340B Litigation US proceedings In August 2023, AstraZeneca filed a lawsuit against the State of Louisiana alleging that the Louisiana’s 340B statute, which requires manufacturers to recognize an unlimited number of contract pharmacies, is preempted on several grounds and violates the Contracts Clause of the U.S. Constitution. AstraZeneca and the State of Louisiana have moved for summary judgment on AstraZeneca’s claims. Legal proceedings brought against AstraZeneca which have been concluded COVID-19 Vaccine Supply and Manufacturing Inquiries Brazil proceedings In February 2022, a Brazilian Public Prosecutor filed a lawsuit against several defendants including the Brazilian Federal Government, AstraZeneca, and other COVID-19 vaccine manufacturers. In April 2022, a Brazilian Court issued an order dismissing the lawsuit. In October 2023, the pending appeal was dismissed. No further appeal was made. This matter is now concluded. Legal proceedings brought by AstraZeneca which have been concluded US 340B Litigation US proceedings In January 2021, AstraZeneca filed a lawsuit in the US District Court for the District of Delaware (District Court) alleging that an Advisory Opinion issued by the Department of Health and Human Services violates the Administrative Procedure Act. In June 2021, the District Court found in favour of AstraZeneca, invalidating the Advisory Opinion. However, in May 2021, prior to the District Court’s ruling, the US Government issued new and separate letters to AstraZeneca (and other companies) asserting that AstraZeneca’s contract pharmacy policy violates the 340B statute. AstraZeneca amended the complaint to include allegations challenging the letter sent in May 2021, and in February 2022, the District Court ruled in favour of AstraZeneca invalidating those letters sent by the US Government. In January 2023, the Court of Appeals affirmed the District Court’s decision in AstraZeneca’s favour. Final judgment was entered in favour of AstraZeneca in May 2023 and this matter is now concluded. Other Additional government inquiries As is true for most, if not all, major prescription pharmaceutical companies, AstraZeneca is currently involved in multiple inquiries into drug marketing and pricing practices. In addition to the investigations described above, various law enforcement offices have, from time to time, requested information from the Group. There have been no material developments in those matters. Tax AstraZeneca considers whether it is probable that a taxation authority will accept an uncertain tax treatment. If it is concluded that it is not probable that the taxation authority will accept an uncertain tax treatment, where tax exposures can be quantified, a tax liability is recognised based on either the most likely amount method or the expected value method depending on which method management expects to better predict the resolution of the uncertainty. Tax liabilities for uncertain tax treatments can be built up over a long period of time but the resolution of such tax exposures usually occurs at a point in time, and given the inherent uncertainties in assessing the outcomes of these exposures (which sometimes can be binary in nature), we could, in future periods, experience adjustments to the liabilities recognised in respect of uncertain tax treatments that have a material positive or negative effect on our results in any particular period. Details of the movements in relation to material uncertain tax treatments are discussed below. AstraZeneca faces a number of audits and reviews in jurisdictions around the world and, in some cases, is in dispute with the tax authorities. The issues under discussion are often complex and can require many years to resolve. Tax liabilities recognised for uncertain tax treatments require management to make key judgements with respect to the outcome of current and potential future tax audits, and actual results could vary from these estimates. Management does not believe a significant risk of material change to uncertain tax positions exists in the next 12 months. The total net tax liability recognised in the Group Financial Statements in respect of uncertain tax positions is $1,336m (2022: $830m; 2021: $768m). The net tax liability consists of $1,241m (2022: $632m; 2021: $702m) included within income tax payable, $441m (2022: $291m; 2021: $(33)m) included within deferred tax asset, partially offset by $9m (2022: $(20)m; 2021: $(17)m) included within deferred tax liabilities, and $337m (2022: $113m; 2021: additional $82m) included within income tax receivable. Transfer pricing The net tax liability included in the Group Financial Statements to cover the worldwide exposure to uncertain tax treatments is $401m (2022: $260m; 2021: $77m). The increase in the net tax liability for uncertain tax positions relating to transfer pricing of $141m compared with 2022 is mainly as a result of an increase of tax liabilities arising from updates to estimates of prior period tax liabilities following progression of tax authority reviews. These matters can be complex and judgemental. The liability includes uncertain tax treatments which are estimated using the expected value method and depend on AstraZeneca’s assessment of the likelihood of the approach taken by the tax authorities and could change in the future to reflect progress in tax authority reviews, the extent that any tax authority challenge is concluded, or matters lapse including following expiry of the relevant statutes of limitation resulting in a reduction in the tax charge in future periods. For transfer pricing matters, including items under tax audit, AstraZeneca estimates the potential for additional tax liabilities above the amount provided where the possibility of the additional liabilities falling due is more than remote, to be up to $386m (2022: $245m; 2021: $48m) including associated interest. Notes to the Group Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 209 Strategic Report Corporate Governance Financial Statements Additional Information |
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30 Commitments, contingent liabilities and contingent assets continued Management believes that it is unlikely that these additional liabilities will arise. It is possible that some of these contingencies may change in the future to reflect progress in tax authority reviews, to the extent that any tax authority challenge is concluded or matters lapse including following expiry of the relevant statutes of limitation resulting in a reduction in the tax charge in future periods. Management continues to believe that AstraZeneca’s positions on all its transfer pricing positions, audits and disputes are robust, and that AstraZeneca has recognised appropriate tax balances, including consideration of whether corresponding relief will be available under Mutual Agreement procedures or unilaterally. Other uncertain tax treatments Included in the net tax liability is $935m (2022: $570m; 2021: $691m) relating to a number of other uncertain tax treatments. The increase of $365m in the net tax liability relating to the other uncertain tax treatments mainly relates to an update to tax liabilities following progress of reviews by tax authorities and administrative appeal processes. The liability includes tax liabilities in respect of uncertain tax treatments which are estimated using the most likely amount method and the expected value method and depend on AstraZeneca’s assessment of the likelihood of the approach taken by the tax authorities. This could change in the future to reflect progress in tax authority reviews, the extent that any tax authority challenge is concluded, or matters lapse including following expiry of the relevant statutes of limitation resulting in a reduction in the tax charge in future periods. For these other tax liabilities in respect of uncertain tax treatments, AstraZeneca estimates the potential for additional liabilities above the amount provided where the possibility of the additional liabilities falling due is more than remote, to be up to $293m (2022: $209m; 2021: $273m) including associated interest. It is possible that some of these liabilities may reduce in the future if any tax authority challenge is concluded or matters lapse following expiry of the relevant statutes of limitation, resulting in a reduction in the tax charge in future periods. AstraZeneca does not believe there are any significant other uncertain tax treatments where the possibility of the additional liabilities falling due is more than remote (2022: $280m; 2021: $325m) including associated interest. Timing of cash flows and interest The Group is currently under audit in several countries and the timing of any resolution of these audits is uncertain. It is anticipated that tax payments may be required in relation to a number of significant disputes which may be resolved over the next one to two years. AstraZeneca considers the tax liabilities set out above to appropriately reflect the expected value of any final settlement. Some of the items discussed above are not currently within the scope of tax authority audits and may take longer to resolve. Included within other payables is a net amount of interest arising on tax contingencies of $184m (2022: $106m; 2021: $85m). 31 Statutory and other information 2023 2022 2021 $m $m $m Fees payable to PricewaterhouseCoopers LLP and its associates: Group audit fee 10.2 9.9 10.5 Fees payable to PricewaterhouseCoopers LLP and its associates for other services: The audit of subsidiaries pursuant to legislation 15.0 15.1 15.2 Attestation under s404 of Sarbanes-Oxley Act 2002 3.3 3.1 2.0 Audit-related assurance services 1.1 0.7 4.5 Other assurance services 0.2 0.2 3.4 Fees payable to PricewaterhouseCoopers Associates in respect of the Group’s pension schemes: The audit of subsidiaries’ pension schemes 0.3 0.3 0.3 30.1 29.3 35.9 $0.7m of fees payable in 2023 are in respect of the Group audit and audit of subsidiaries related to prior years (2022: $0.6m in respect of the Group audit and audit of subsidiaries related to prior years). $0.3m of 2021 Group audit fees and $0.7m of 2021 Audit-related assurance services and Other assurance services relate to pre-acquisition fees incurred by Alexion. Included in the 2021 Audit-related assurance services and Other assurance services are $6.1m of services provided in relation to the acquisition of Alexion and related debt issuance. Related party transactions The Group had no material related party transactions which might reasonably be expected to influence decisions made by the users of these Financial Statements. Key management personnel compensation Key management personnel are defined for the purpose of disclosure under IAS 24 ‘Related Party Disclosures’ as the members of the Board and the members of the SET. 2023 2022 2021 $’000 $’000 $’000 Short-term employee benefits 38,636 38,632 32,985 Post-employment benefits 1,354 1,388 1,378 Share-based payments 58,242 56,297 45,234 98,232 96,317 79,597 Total remuneration is included within employee costs (see Note 29). 32 Subsequent events There were no material subsequent events. 210 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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At 31 December 2023 Group Interest At 31 December 2023 Group Interest At 31 December 2023 Group Interest Group Subsidiaries and Holdings In accordance with section 409 of the Companies Act 2006 a full list of subsidiaries, partnerships, associates, joint ventures and joint arrangements, the place of incorporation, registered office address, and the effective percentage of equity owned as at 31 December 2023 are disclosed below. Unless otherwise stated, the share capital disclosed comprises ordinary shares which are indirectly held by AstraZeneca PLC. Unless otherwise stated, the accounting year ends of subsidiaries are 31 December. The Group Financial Statements consolidate the Financial Statements of the Company and its subsidiaries at 31 December 2023. Wholly owned subsidiaries Algeria AAPM SARL 100% Number 20, Micro-Economic Zone, Hydra Business Center, Dar El Medina, Algiers, Algeria Argentina AstraZeneca S.A. 100% Olga Cossettini 363, 3° floor, Buenos Aires, Argentina Alexion Pharma Argentina SRL 100% Avenida Leandro N. Alem 592 Piso 6, Buenos Aires, Argentina Australia AstraZeneca Holdings Pty Limited 100% AstraZeneca Pty Limited 100% Alexion Pharmaceuticals Australasia Pty Ltd 100% 66 Talavera Road, Macquarie Park, NSW 2113, Australia LogicBio Australia Pty Limited 100% Level 40, 2-26 Park Street, Sydney, NSW 2000, Australia Austria AstraZeneca Österreich GmbH 100% A-1120 Wien, Rechte Wienzeile 223 Tür 16.1, Austria Alexion Pharma Austria GmbH 100% Donau-City-Straße 7, 30. Stock, DC Tower, Vienna 1220, Austria Portola Österreich GmbH (in liquidation) 100% Mooslackengasse 17, 1190 Wien, Austria Belgium AstraZeneca S.A. / N.V. 100% Alfons Gossetlaan 40 bus 201 at 1702 Groot-Bijgaarden, Belgium Alexion Pharma Belgium Sprl 100% Alexion Services Europe Sprl 100% de Meeûssquare 37, Bruxelles 1000, Belgium Bermuda Alexion Bermuda Holding ULC 100% Alexion Bermuda Limited 100% Alexion Bermuda Partners LP 100% Canon’s Court, 22 Victoria St., Hamilton, Bermuda Brazil AstraZeneca do Brasil Limitada 100% Rod. Raposo Tavares, KM 26, 9, Cotia, Brazil Alexion Farmacêutica América Latina Serviços de Administração de Vendas Ltda. 100% Alexion Serviços e Farmacêutica do Brasil Ltda. 100% Av. Dr Chucri Zaidan, 1240, 15° andar, CEP 04711-130, Ed. Morumbi Corporate – Golden Tower Vila São Francisco, São Paulo, Brazil Bulgaria AstraZeneca Bulgaria EOOD 100% 1057 Sofia, Izgrev Region, 36 Dragan Tsankov Blvrd, Bulgaria Canada AstraZeneca Canada Inc.1 100% Suite 5000, 1004 Middlegate Road, Mississanga, ON, L4Y 1M4, Canada Alexion Pharma Canada Corporation 100% 1300-1969 ST Upper Water, Halifax, NS, B3J 3R7, Canada Cayman Islands AZ Reinsurance Limited 100% 18 Forum Lane, 2nd Floor, Camana Bay, Grand Cayman, P.O. Box 69, Cayman Islands Grey Wolf Merger Sub 100% PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands Chile AstraZeneca S.A. 100% AstraZeneca Farmaceutica Chile Limitada 100% Av. Isidora Goyenechea 3477, 2nd Floor, Las Condes, Santiago, Chile China AstraZeneca Pharmaceutical Co., Limited 100% No. 2, Huangshan Road, Wuxi, Jiangsu Province, China AstraZeneca (Wuxi) Trading Co. Ltd 100% Building E, Huirong Plaza, Jinghui Road East, Xinwu District, Wuxi, Jiangsu Province, China AstraZeneca Investment (China) Co., Ltd 100% 199 Liangjing Road, China (Shanghai) Pilot Free Trade Zone, Shanghai, China AstraZeneca Pharmaceutical (China) Co. Ltd 100% No. 9, Medical Avenue, Jiangsu Province, Taizhou, China AstraZeneca Pharmaceutical (Beijing) Co., Ltd 100% 1F, Building No. 4, No. 8 Courtyard, No. 1 Kegu Street, Beijing Economic-Technological Development Area, Beijing 100176, China AstraZeneca (Guangzhou) Pharmaceutical Co., Ltd 100% Room 406-178, No. 1, Yichuang Street, (China-Singapore Guangzhou Knowledge City) Huangpu District, Guangzhou City, China AstraZeneca Investment Consulting (Wuxi) Co., Ltd 100% Room 808, 8F, Building 99-2 Linghu Avenue, Xinwu District, Wuxi, Jiangsu, China AstraZeneca Pharmaceutical (Hangzhou) Co., Ltd 100% 12F & 14F, Building 1, Shuli Plaza, 758 Fei Jia Tang Road, Gongshu District, Hangzhou, Zhejiang Province, China AstraZeneca Global R&D (China) Co., Ltd 100% 16F, 88 Xizang North Road, Jing’an District, Shanghai, China AstraZeneca Pharmaceutical (Chengdu) Co., Ltd 100% 10th Floor, Building 11 (Building E11), No. 366, Hemin Street, Chengdu High-tech Zone, China (Sichuan) Pilot Free Trade Zone, China AstraZeneca Pharmaceutical (Shanghai) Co., Ltd 100% B1F, 8F & 9F, 88 Xizang North Road, Jing’an District, Shanghai, China Alexion Pharmaceuticals (Shanghai) Company Limited 100% Room 702, No. 1539 West Nanjing Road, Jing’an District, Shanghai, China AstraZeneca Pharmaceutical Manufacturing (Qingdao) Co., Ltd. 100% AstraZeneca Pharmaceutical (Qingdao) Co., Ltd. 100% Room 806, Building 2, No. 82 Juxianqiao Road, High-tech Zone, Qingdao City, Shandong Province, China Colombia AstraZeneca Colombia S.A.S. 100% Av Carrera 9 No. 101-67 Office 601, Bogotá, 110231, Colombia Alexion Pharma Colombia S.A.S. 100% Carrera 9 No. 115 - 06 /30 Edificio Tierra Firme Oficina 2904 Bogotá D.C., Colombia Costa Rica AstraZeneca CAMCAR Costa Rica, S.A. 100% San José, Escazú, Roble Corporate Center, 5to piso, Costa Rica Croatia AstraZeneca d.o.o. 100% Radnicka cesta 80, 10000 Zagreb, Croatia Group Subsidiaries and Holdings AstraZeneca Annual Report & Form 20-F Information 2023 211 Strategic Report Corporate Governance Financial Statements Additional Information |
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At 31 December 2023 Group Interest At 31 December 2023 Group Interest At 31 December 2023 Group Interest Group Subsidiaries and Holdings continued Czech Republic AstraZeneca Czech Republic, s.r.o. 100% U Trezorky 921/2, 158 00 Prague 5, Czech Republic Alexion Pharma Czech s.r.o. 100% Novodvorská 994/138, Braník, 142 00 Prague, Czech Republic Denmark AstraZeneca A/S 100% Johanne Møllers Passage 1, Dk-1799 Copenhagen V, Denmark Egypt AstraZeneca Egypt for Pharmaceutical Industries SAE 100% 6th of October City, 6th Industrial Zone, Plot 2, Giza, Egypt AstraZeneca Egypt LLC 100% 47 St. 270 New Maadi, Cairo, Egypt Drimex LLC 100% Plot 133, Banks’ District, 5th Settlement, New Cairo, Cairo, Egypt Estonia AstraZeneca Eesti OÜ 100% Harju maakond, Tallinn, Lasnamäe linnaosa, Valukoja tn 8/1, 11415, Estonia Finland AstraZeneca Oy. 100% Keilaranta 18, 02150 Espoo, Finland France AstraZeneca SAS 100% Tour Carpe Diem-31, Place des Corolles, 92400 Courbevoie, France AstraZeneca Reims Production SAS 100% Chemin de Vrilly Parc, Industriel de la Pompelle, Reims, 51100, France AstraZeneca Dunkerque Production SCS 100% 224 Avenue de la Dordogne, 59640 Dunkerque, France Alexion Europe SAS 100 % Alexion Pharma France SAS 100 % 103-105 Rue Anatole France 92300 Levallois-Perret, France Germany AstraZeneca Holding GmbH 100% AstraZeneca GmbH 100% Friesenweg 26, 22763, Hamburg, Germany Sofotec GmbH 100% Benzstrasse 1-3, 61352, Bad Homburg v.d. Hohe, Germany AstraZeneca Computational Pathology GmbH2 100% Bernhard-Wicki-Straße 5, 80636, Munich, Germany Alexion Pharma Germany GmbH 100% Landsberger Straße 300, 80687, Munich, Germany Greece AstraZeneca S.A. 100% Agisilaou 6-8 Marousi, Athens, Greece Hong Kong AstraZeneca Hong Kong Limited 100% Unit 1 – 3, 11/F., China Taiping Finance Centre, 18 King Wah Road, North Point, Hong Kong Hungary AstraZeneca Kft 100% 1st floor, 4 building B, Alíz str., Budapest, 1117, Hungary India AstraZeneca India Private Limited3 100% Block A, Neville Tower, 11th Floor, Ramanujan IT SEZ, Taramani, Chennai, Tamil Nadu, PIN 600113, India Alexion Business Services Private Limited 100% 9th Floor, Platina, G Block Plot No. C-59, Bandra-Kurla Complex Bandra (East), Mumbai 400051, India Iran AstraZeneca Pars Company 100% Suite 1, 1st Floor No. 39, Alvand Ave., Argantin Sq., Tehran 1516673114, Iran Ireland AstraZeneca Pharmaceuticals (Ireland) Designated Activity Company 100% 4th Floor, South Bank House, Barrow Street, Dublin, 4, Republic of Ireland Alexion Pharma Holding Limited 100% Alexion Pharma International Operations Limited 100% Alexion Pharma Development Limited 100% AstraZeneca Ireland Limited 100% College Business & Technology Park, Blanchardstown Road North, Dublin 15, Republic of Ireland Israel AstraZeneca (Israel) Ltd 100% Atirei Yeda 1, Building O-Tech 2, POB 8044, Kfar Saba, 4464301, Israel Alexion Pharma Israel Ltd 100% 4 Weizmann Str., Tel-Aviv-Jaffa, Israel Italy Simesa SpA 100% AstraZeneca SpA 100% Alexion Pharma Italy Srl 100% Viale Decumano 39, 20157 Milan, Italy Japan AstraZeneca K.K. 100% Grand Front Osaka Tower B, 3-1, Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan Alexion Pharma GK 100% Ebisu First Square, 18-14, Ebisu 1-chome, Shibuya-ku, Tokyo, Japan Kazakhstan AstraZeneca Kazakhstan LLP 100% Office 101, 77 Kunayev Street, Almaty 050000, Kazakhstan Kenya AstraZeneca Pharmaceuticals Limited 100% L.R. No.1/1327, Avenue 5, 1st Floor, Rose Avenue, Nairobi, Kenya Latvia AstraZeneca Latvija SIA 100% Skanstes iela 50, Riga, LV-1013, Latvia Lithuania AstraZeneca Lietuva UAB 100% Spaudos g., Vilnius, LT-05132, Lithuania Luxembourg AstraZeneca Luxembourg S.A. 100% Rue Nicolas Bové 2A – L-1253, Luxembourg Malaysia AstraZeneca Asia-Pacific Business Services Sdn Bhd 100% 12th Floor, Menara Symphony, No. 5 Jalan Prof, Khoo Kay Kim, Seksyen 13, 46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia AstraZeneca Sdn Bhd 100% Nucleus Tower, Level 11 & 12, No. 10 Jalan PJU 7/6, Mutiara Damansara, 47800 Petaling Jaya, Selangor Darul Ehsan, Malaysia Mexico AstraZeneca Health Care Division, S.A. de C.V. 100% AstraZeneca, S.A. de C.V. 100% Av. Periferico Sur 4305 interior 5, Colonia Jardines en la Montaña, Mexico City, Tlalpan Distrito Federal, CP 14210, Mexico Alexion Pharma Mexico S. de R.L. de C.V. 100% Paseo de los Tamarindos 90, Torre 1 piso 6 - A Col., Bosques de la Lomas, CP 05120 D.F, Mexico Morocco AstraZeneca Maroc SARLAU 100% 92 Boulevard Anfa ETG 2, Casablanca 20000, Morocco The Netherlands AstraZeneca B.V. 100% AstraZeneca Continent B.V. 100% AstraZeneca Gamma B.V. 100% AstraZeneca Holdings B.V. 100% AstraZeneca Jota B.V. 100% AstraZeneca Rho B.V. 100% AstraZeneca Sigma B.V. 100% AstraZeneca Treasury B.V. 100% AstraZeneca Zeta B.V. 100% Prinses Beatrixlaan 582, 2595BM, The Hague, The Netherlands 212 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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At 31 December 2023 Group Interest At 31 December 2023 Group Interest At 31 December 2023 Group Interest AstraZeneca Nijmegen B.V. 100% Lagelandseweg 78, 6545 CG Nijmegen, The Netherlands Acerta Pharma B.V. 100% Aspire Therapeutics B.V. 100% Kloosterstraat 9, 5349 AB, Oss, The Netherlands Portola Netherlands B.V. 100% Prins Bernhardplein 200 JB Amsterdam 1097, The Netherlands Alexion Holding B.V. 100% Alexion Pharma Foreign Holdings B.V. 100% Alexion Pharma Netherlands B.V. 100% Prinses Beatrixlaan 582, 5895 BM, The Hague, The Netherlands Neogene Therapeutics B.V. 100% Science Park 106, 1098 XG Amsterdam, The Netherlands New Zealand AstraZeneca Limited 100% Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics, 58 Richard Pearse Drive, Mangere, Auckland, 1142, New Zealand Nigeria AstraZeneca Nigeria Limited 100% 11A, Alfred Olaiya Street, Awuse Estate, Off Salvation Street, Opebi, Ikeja, Lagos, Nigeria Norway AstraZeneca AS 100% Karvesvingen 7, 0579 Oslo, Norway Pakistan AstraZeneca Pharmaceuticals Pakistan (Private) Limited4 100% Office No 1, 2nd Floor, Sasi Arcade, Block 7, Main Clifton Road, Karachi, Pakistan Panama AstraZeneca CAMCAR, S.A. 100% Bodega #1, Parque Logistico MIT, Carretera Hacia Coco Solo, Colon, Panama Peru AstraZeneca Peru S.A. 100% Calle Las Orquídeas N° 675, Int. 802, Edificio Pacific Tower, San Isidro, Lima, Peru Philippines AstraZeneca Pharmaceuticals (Phils.) Inc. 100% 16th Floor, Inoza Tower, 40th Street, Bonifacio Global City, Taguig 1634, Philippines Poland AstraZeneca Pharma Poland Sp.z.o.o. 100% Alexion Pharma Poland Sp.z.o.o. 100% Postepu 14, 02-676, Warszawa, Poland Portugal Astra Alpha Produtos Farmacêuticos Lda 100% AstraZeneca Produtos Farmacêuticos Lda 100% Novastra Promoção e Comércio Farmacêutico Lda 100% Novastuart Produtos Farmacêuticos Lda 100% Stuart-Produtos Farmacêuticos Lda 100% Zeneca Epsilon – Produtos Farmacêuticos Lda 100% Zenecapharma Produtos Farmacêuticos, Unipessoal Lda 100% Rua Humberto Madeira, No 7, Queluz de Baixo, 2730-097, Barcarena, Portugal Puerto Rico IPR Pharmaceuticals, Inc. 100% Road 188, San Isidro Industrial Park, Canóvanas, 00729, Puerto Rico Romania AstraZeneca Pharma S.R.L. 100% Bucharest, 1A Tipografilor Street, MUSE Offices, 2nd and 3rd Floor, District 1, 013714, Romania Russia AstraZeneca Industries, LLC 100% 8 1st Vostochniy lane, Dobrino village, Borovskiy district, Kaluga region 249006, Russian Federation AstraZeneca Pharmaceuticals, LLC 100% Building 1, 21 First Krasnogvardeyskiy lane, floor 30, rooms 13 and 14, Moscow, 123112, Russian Federation Alexion Pharma OOO LLC 100% Building 1, 21 First Krasnogvardeyskiy lane, floor 29, Moscow, 123112, Russian Federation Saudi Arabia AstraZeneca Continent – Regional Headquarter 100% Al-Nakhlah Tower, Floor 13th Ath Thumamah Road, Al Sahafa District., P.O. Box 42150, Riyadh, Kingdom of Saudi Arabia AstraZeneca Trading Company 100% 125 Prince Sultan, 2086 Ar Rawdah District, 23435, Jeddah, Kingdom of Saudi Arabia Singapore AstraZeneca Singapore Pte Limited 100% 10 Kallang Avenue #12-10, Aperia Tower 2, 339510, Singapore South Africa AstraZeneca Pharmaceuticals (Pty) Limited 100% 17 Georgian Crescent West, Northdowns Office Park, Bryanston, 2191, South Africa South Korea AstraZeneca Korea Co. Ltd 100% 21st Floor, Asem Tower, 517, Yeongdong-daero, Gangnam-gu, Seoul, 06164, Republic of Korea Alexion Pharma Korea LLC 100% 41 FL., 152 Teheran-ro (Yeoksam-dong Gangnam Finance Center), Gangnam-gu, Seoul, Republic of Korea Spain AstraZeneca Farmaceutica Holding Spain, S.A. 100% AstraZeneca Farmaceutica Spain S.A. 100% Laboratorio Beta, S.A. 100% Laboratorio Lailan, S.A. 100% Laboratorio Tau, S.A. 100% Fundación AstraZeneca 100% Calle del Puerto de Somport, 21-23, 28050, Madrid, Spain Alexion Pharma Spain S.L. 100% Av Diagonal Num.601 P.1, Barcelona 08028, Spain Sweden Astra Export & Trading Aktiebolag 100% Astra Lakemedel Aktiebolag 100% AstraZeneca AB 100% AstraZeneca Biotech AB 100% AstraZeneca BioVentureHub AB 100% AstraZeneca Holding Aktiebolag5 100% AstraZeneca International Holdings Aktiebolag6 100% AstraZeneca Nordic AB 100% AstraZeneca Pharmaceuticals Aktiebolag 100% AstraZeneca Södertälje 2 AB 100% Stuart Pharma Aktiebolag 100% Tika Lakemedel Aktiebolag 100% SE-151 85 Södertälje, Sweden Aktiebolaget Hassle 100% Symbicom Aktiebolag6 100% 431 83 MoIndal, Sweden Astra Tech International Aktiebolag 100% Box 14, 431 21 MoIndal, Sweden Alexion Pharma Nordics Holding AB 100% Alexion Pharma Nordics AB 100% Kungsgatan 3, Stockholm 111 43, Sweden Switzerland AstraZeneca AG 100% Evinova AG 100% Neuhofstrasse 34, 6340 Baar, Switzerland Spirogen Sarl6 100% Rue du Grand-Chêne 5, CH-1003 Lausanne, Switzerland Alexion Pharma GmbH 100% Giesshübelstrasse 30, Zürich 8045, Switzerland Group Subsidiaries and Holdings AstraZeneca Annual Report & Form 20-F Information 2023 213 Strategic Report Corporate Governance Financial Statements Additional Information |
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Group Subsidiaries and Holdings continued At 31 December 2023 Group Interest At 31 December 2023 Group Interest At 31 December 2023 Group Interest Taiwan AstraZeneca Taiwan Limited 100% 21st Floor, Taipei Metro Building 207, Tun Hwa South Road, SEC 2 Taipei, Taiwan Alexion Pharma Taiwan Ltd 100% Room 1153, 11F, No. 1, SongZhi Rd, Taipei 11047, Taiwan Thailand AstraZeneca (Thailand) Limited 100% Asia Centre 19th floor, 173/20, South Sathorn Rd, Khwaeng Thungmahamek, Khet Sathorn, Bangkok, 10120, Thailand Tunisia AstraZeneca Tunisie SaRL 100% Lot n°1.5.5 les jardins du lac, bloc B les berges du lac Tunis, Tunisia Turkey AstraZeneca Ilac Sanayi ve Ticaret Limited Sirketi 100% YKB Plaza, B Blok, Kat:3-4, Levent/Besiktas, Istanbul, Turkey Zeneca Ilac Sanayi ve Ticaret Anonim Sirketi 100% Büyükdere Cad., Y.K.B. Plaza, B Blok, Kat:4, Levent/Bes¸iktas¸, Istanbul, Turkey Alexion Ilac Ticaret Limited Sirketi 100% Içerenköy Mahellisi Umut SK. and Ofis Sit. No: 10 12/73 Atas¸ehir, Istanbul 10-12/73, Turkey Ukraine AstraZeneca Ukraina LLC 100% 54 Simi Prakhovykh street, Kyiv, 01033, Ukraine United Arab Emirates AstraZeneca FZ-LLC 100% P.O. Box 505070, Block D, Dubai Healthcare City, Oud Mehta Road, Dubai, United Arab Emirates Alexion Pharma Middle East FZ-LLC 100% Dubai Science Park, 501, Floor 5, EIB Building No. 2, Dubai, United Arab Emirates United Kingdom Ardea Biosciences Limited 100% Arrow Therapeutics Limited 100% Astra Pharmaceuticals Limited 100% AstraPharm6 100% AstraZeneca China UK Limited 100% AstraZeneca Death In Service Trustee Limited 100% AstraZeneca Employee Share Trust Limited 100% AstraZeneca Finance Limited 100% AstraZeneca Intermediate Holdings Limited5 100% AstraZeneca Investments Limited 100% AstraZeneca Japan Limited 100% AstraZeneca Nominees Limited 100% AstraZeneca Quest Limited 100% AstraZeneca Share Trust Limited 100% AstraZeneca Sweden Investments Limited 100% AstraZeneca Treasury Limited6 100% AstraZeneca UK Limited 100% AstraZeneca US Investments Limited5 100% AZENCO2 Limited 100% AZENCO4 Limited 100% Cambridge Antibody Technology Group Limited 100% KuDOS Horsham Limited 100% KuDOS Pharmaceuticals Limited 100% Zenco (No. 8) Limited 100% Zeneca Finance (Netherlands) Company 100% MedImmune Limited 100% 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, United Kingdom MedImmune U.K. Limited 100% Plot 6, Renaissance Way, Boulevard Industry Park, Liverpool, L24 9JW, United Kingdom Syntimmune Limited 100% 21 Holborn Viaduct, London, EC1A 2DY, United Kingdom Alexion Pharma UK Limited 100% Portola Pharma UK Limited (in liquidation) 100% 3 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1EZ, United Kingdom United States Ardea Biosciences, Inc. 100% Amylin Ohio LLC7 100% Amylin Pharmaceuticals, LLC7 100% AstraZeneca Collaboration Ventures, LLC7 100% AstraZeneca Finance LLC7 100% AstraZeneca Finance and Holdings Inc. 100% AstraZeneca Pharmaceuticals LP8 100% Atkemix Nine Inc. 100% Atkemix Ten Inc. 100% BMS Holdco, Inc. 100% Cincor Pharma Inc. 100% Corpus Christi Holdings Inc. 100% Isochrone Merger Sub Inc. 100% Neogene Therapeutics, Inc. 100% Omthera Pharmaceuticals, Inc. 100% Optein, Inc. 100% Stauffer Management Company LLC7 100% Zeneca Holdings Inc. 100% Zeneca Inc. 100% Zeneca Wilmington Inc.5 100% 1800 Concord Pike, Wilmington, DE 19803, United States ZS Pharma Inc. 100% 1100 Park Place, Suite 300, San Mateo, CA 94403, United States AlphaCore Pharma, LLC7 100% 333 Parkland Plaza, Suite 5, Ann Arbor, MI 48103, United States AZ-Mont Insurance Company 100% 100 Bank Street, Suite 630, Burlington, VT 05401, United States MedImmune, LLC7 100% MedImmune Ventures, Inc. 100% One MedImmune Way, Gaithersburg, MD 20878, United States Pearl Therapeutics, Inc. 100% 200 Cardinal Way, Redwood City, CA 94063, United States Caelum Biosciences Inc. 100% 1200 Florence Columbus Road, Bordentown, NJ 08505, United States Alexion Services Latin America Inc. 100% 600 Brickell Ave, Miami, FL 33131, United States Portola USA, Inc. 100% Portola Pharmaceuticals LLC 100% 270 East Grand Avenue, South San Francisco, CA 94080, United States Achillion Pharmaceuticals Inc. 100% Alexion Delaware Holding LLC 100% Alexion Pharma LLC 100% Alexion Pharmaceuticals, Inc. 100% Alexion US1 LLC 100% Alexion US Holdings LLC 100% LogicBio Therapeutics, Inc. 100% Savoy Therapeutics Corp 100% Syntimmune, Inc. 100% TeneoTwo, Inc. 100% 121 Seaport Boulevard, Boston, MA 02210, United States Acerta Pharma LLC7 100% 121 Oyster Point Boulevard, South San Francisco, CA 94080, United States LogicBio Securities Corporation 100% 65 Hayden Avenue, Lexington, MA 92421, United States Alexion Holding LLC 100% 100 College Street, New Haven, CT 06510, United States Uruguay AstraZeneca S.A. 100% Yaguarón 1407 of 1205, 11.100, Montevideo, Uruguay Venezuela AstraZeneca Venezuela S.A. 100% Gotland Pharma S.A. 100% Av. La Castellana, Torre La Castellana, Piso 5, Oficina 5-G, 5-H, 5-I, Urbanización La Castellana, Municipio Chacao, Estado Bolivariano de Miranda, Venezuela Vietnam AstraZeneca Vietnam Company Limited 100% 18th Floor, A&B Tower, 76 Le Lai, Ben Thanh Ward, District 1, Ho Chi Minh City, Vietnam 214 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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At 31 December 2023 Group Interest At 31 December 2023 Group Interest At 31 December 2023 Group Interest Subsidiaries where the effective interest is less than 100% Algeria AstraZeneca Algeria Pharmaceutical Industries SPA 49% N° 20, Micro Zone d’Activité Hydra, Centre des Affaires Dar El Madina, Bloc A, 6th Floor, Hydra, Algiers, Algeria China Beijing Falikang Pharmaceutical (China) Co. Ltd 49% No. 69 Fushi Road, Haidian District, Beijing, 100143, China India AstraZeneca Pharma India Limited3 75% Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, Bangalore-560 045, India Indonesia P.T. AstraZeneca Indonesia 95% Perkantoran Hijau Arkadia Tower F, 3rd Floor, JI. T.B. Simatupang Kav. 88, South Jakarta, 12520, Indonesia Joint Ventures China WuXi MedImmune Biopharmaceutical Co., Limited (in liquidation) 50% Room 1902, 19/F, Lee Garden One, 33 Hysan Avenue, Causeway Bay, Hong Kong IHP HK Holdings Limited 50% Unit 5805, 58/F., Two International Finance Centre 8 Finance Street, Central, China United Kingdom Centus Biotherapeutics Limited (in liquidation) 50% c/o Cork Gully LLP, 40 Villiers Street, London, WC2N 6NJ, United Kingdom Ireland Centus Biotherapeutics Europe Limited (in liquidation) 50% 6th Floor, South Bank House, Barrow Street, Dublin 4, Republic of Ireland United States Montrose Chemical Corporation of California 50% Suite 380, 600 Ericksen Ave N/E, Bainbridge Island, United States Significant Holdings China Dizal (Jiangsu) Pharmaceutical Co., Ltd. 26.69% 199 Liangjing Rd, Zhangjiang Hi-Tech Park, Pudong District, Shanghai, 201203, China Wuxi AstraZeneca-CICC Venture Capital Partnership (Limited Partnership) 22.13% Room 808, 8F, Building 99-2 Linghu Avenue, Xinwu District, Wuxi, Jiangsu, China United Kingdom VaxEquity 40% Lab 4 Cambridge Science Park, Unit 204 Milton Road, Cambridge, CB4 0GZ, United Kingdom United States C.C. Global Chemicals Company 37.50% PO Box 7, MS2901, Texas, TX76101-0007, United States Associated Holdings France Medetia SAS 10% Institute Imagine 24, Boulevard du Montparnasse 75015, Paris, France Cellectis S.A. 22.35% 8, rue de la Croix Jarry, 75013 Paris, France Israel AION Labs Innovation Lab Ltd. 19.23% 4 Oppenheimer Street, Building B, Rehovot, 7670104, Israel CombinAble.AI Ltd. 11.25% 5 Oppenheimer Street, Building B, Rehovot, 7670104, Israel TenAces Biosciences Ltd. 12.50% 6 Oppenheimer Street, Building B, Rehovot, 7670104, Israel Sweden Swedish Orphan Biovitrum AB (publ) 9.89% Tomtebodavägen 23A, Stockholm, Sweden OnDosis AB 19.90% GoCo House, 5 tr, Gemenskapens gata 9, 431 53 Mölndal, Sweden CCRM Nordic AB 19.90% CCRM Nordic AB, c/o GU Ventures AB, Erik Dahlbergsgatan 11 A, 411 26 Göteborg, Sweden United Kingdom Niox Group plc 16.89% Hayakawa Building, Edmund Halley Road, Oxford Science Park, Oxford, OX4 4GB, United Kingdom United States AbMed Corporation 18% 68 Cummings Park Drive, Woburn, MA 01801, United States Baergic Bio, Inc. 19.95% 1111 Kane Concourse, Suite 301 Bay Harbor Islands, FL 33154, United States Regio Biosciences 19.54% 668 Stoney Hill Road, #2, Yardley, PA 19067, United States Employee Benefit Trust The AstraZeneca Employee Benefit Trust 1 Ownership held in ordinary and class B special shares. 2 Ownership held in common shares, preferred shares 2003, preferred shares 2003 ex (A), preferred shares 2003 ex (B), preferred shares Series D, preferred shares Series E and preferred shares Series F. 3 Accounting year end is 31 March. 4 Accounting year end is 30 June. 5 Directly held by AstraZeneca PLC. 6 Ownership held in Ordinary A shares and Ordinary B shares. 7 Ownership held as membership interest. 8 Ownership held as partnership interest. 9 With effect from 13 January 2023, Namor Merger Sub Inc. was merged with and into Neogene Therapeutics, Inc., with Neogene Therapeutics, Inc. being the surviving corporation. Group Subsidiaries and Holdings AstraZeneca Annual Report & Form 20-F Information 2023 215 Strategic Report Corporate Governance Financial Statements Additional Information |
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Company Balance Sheet at 31 December AstraZeneca PLC 2023 2022 Notes $m $m Fixed assets Fixed asset investments 1 64,189 63,555 64,189 63,555 Current assets Debtors – other 4 4 Debtors – amounts owed by Group undertakings 10,928 2,608 10,932 2,612 Creditors: Amounts falling due within one year Other payables 2 (216) (194) Amounts owed to Group undertakings 3 – (283) Interest-bearing loans and borrowings 3 (2,995) (2,648) (3,211) (3,125) Net current assets/(liabilities) 7,721 (513) Total assets less current liabilities 71,910 63,042 Creditors: Amounts falling due after more than one year Interest-bearing loans and borrowings 3 (16,741) (17,939) Other payables 2 (21) (23) (16,762) (17,962) Net assets 55,148 45,080 Capital and reserves Called-up share capital 4 388 387 Share premium account 35,188 35,155 Capital redemption reserve 153 153 Other reserves 1,779 1,927 Profit and loss account 17,640 7,458 Shareholders’ funds 55,148 45,080 $m means millions of US dollars. The Company’s profit for the year was $14,669m (2022: $380m). The Company Financial Statements from pages 216 to 222 were approved by the Board and were signed on its behalf by Pascal Soriot Aradhana Sarin Director Director 8 February 2024 Company’s registered number 02723534 216 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Company Statement of Changes in Equity for the year ended 31 December Share Capital Share premium redemption Other Profit and Total capital account reserve reserves1 loss account2 equity $m $m $m $m $m $m At 1 January 2022 387 35,126 153 2,182 11,563 49,411 Total comprehensive income for the period Profit for the period – – – – 380 380 Total comprehensive income for the period – – – – 380 380 Transactions with owners, recorded directly in equity Dividends – – – – (4,485) (4,485) Capital contributions for share-based payments – – – (255) – (255) Issue of Ordinary Shares – 29 – – – 29 Total contributions by and distributions to owners – 29 – (255) (4,485) (4,711) At 31 December 2022 387 35,155 153 1,927 7,458 45,080 Total comprehensive income for the period Profit for the period – – – – 14,669 14,669 Total comprehensive income for the period – – – – 14,669 14,669 Transactions with owners, recorded directly in equity Dividends – – – – (4,487) (4,487) Capital contributions for share-based payments – – – (148) – (148) Issue of Ordinary Shares 1 33 – – – 34 Total contributions by and distributions to owners 1 33 – (148) (4,487) (4,601) At 31 December 2023 388 35,188 153 1,779 17,640 55,148 1 The Other reserves arose from the cancellation of £1,255m share premium by the Company in 1993 and the redenomination of share capital of $157m in 1999. Included within Other reserves at 31 December 2023 is $(62)m (31 December 2022: $86m) in respect of cumulative share-based payment awards, which are not available for distribution. 2 At 31 December 2023, the overwhelming majority of the Profit and loss account reserve of $17,640m (31 December 2022: all of $7,458m) was available for distribution, subject to filing these Financial Statements with Companies House. When making a distribution to shareholders, the Directors determine profits available for distribution by reference to guidance on realised and distributable profits under the Companies Act 2006 issued by the Institute of Chartered Accountants in England and Wales and the Institute of Chartered Accountants of Scotland in April 2017. The profits of the Company have been received in the form of receivables due from subsidiaries. The availability of distributable reserves in the Company is dependent on those receivables meeting the definition of qualifying consideration within the guidance, and in particular on the ability of subsidiaries to settle those receivables within a reasonable period of time. The Directors consider that, based on the nature of these receivables and the available cash resources of the Group and other accessible sources of funds, at 31 December 2023, the overwhelming majority (31 December 2022: all) of the Company’s profit and loss reserves were available for distribution. Company Statement of Changes in Equity AstraZeneca Annual Report & Form 20-F Information 2023 217 Strategic Report Corporate Governance Financial Statements Additional Information |
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Company Accounting Policies Basis of presentation of financial information The Company is a private limited company, limited by shares, incorporated and domiciled in England & Wales. The registered address is 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA. These financial statements were prepared in accordance with FRS 101 ‘Reduced Disclosure Framework’. In preparing these financial statements, the Company applied the recognition, measurement and disclosure requirements of International Financial Reporting Standards as adopted by the UK (UK-adopted international accounting standards), but made amendments where necessary in order to comply with the Companies Act 2006 and to take advantage of FRS 101 disclosure exemptions. In these financial statements, the Company has applied the exemptions available under FRS 101 in respect of the following disclosures: > Statement of Cash Flows and related notes > disclosures in respect of transactions with wholly owned subsidiaries > disclosures in respect of capital management > the effects of new but not yet effective IFRSs > disclosures in respect of the compensation of Key Management Personnel. As the Group Financial Statements (presented on pages 148 to 210) include the equivalent disclosures, the Company has also taken the exemptions under FRS 101 available in respect of the following disclosures: > IFRS 2 ‘Share-based Payment’ in respect of Group settled share-based payments > certain disclosures required by IFRS 13 ‘Fair Value Measurement’ and the disclosures required by IFRS 7 ‘Financial Instruments: Disclosures’. No individual profit and loss account is prepared as provided by section 408 of the Companies Act 2006. Basis of accounting The Company Financial Statements are prepared under the historical cost convention and on a going concern basis, in accordance with the Companies Act 2006. The following paragraphs describe the main accounting policies, which have been applied consistently. Estimates and judgements The preparation of the Company Financial Statements in conformity with generally accepted accounting principles requires management to make estimates and judgements that affect the reported amounts of assets and liabilities at the date of the Financial Statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. There are no key judgements or significant estimates. Foreign currencies Foreign currency transactions, being transactions denominated in a currency other than the Company’s functional currency, are translated into US dollars at average rates for the relevant monthly accounting periods, which approximate to actual rates. Monetary assets and liabilities arising from foreign currency transactions are retranslated at exchange rates prevailing at the reporting date. Exchange gains and losses on loans and on short-term foreign currency borrowings and deposits are included within Finance expense. Exchange differences on all other foreign currency transactions are recognised in Operating profit. Non-monetary items arising from foreign currency transactions are not retranslated in the Company’s accounting records. Taxation The current tax payable is based on taxable profit for the year. Taxable profit differs from reported profit because taxable profit excludes items that are either never taxable or tax deductible or items that are taxable or tax deductible in a different period. The Company’s current tax assets and liabilities are calculated using tax rates that have been enacted or substantively enacted by the reporting date. Deferred tax is provided using the balance sheet liability method, providing for temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred tax liabilities are recognised unless they arise from the initial recognition (other than in a business combination) of assets and liabilities in a transaction that affects neither the taxable profit nor the accounting profit. Deferred tax liabilities are not recognised to the extent they arise from the initial recognition of non-tax deductible goodwill. Deferred tax assets are recognised to the extent that there are future taxable temporary differences or it is probable that future taxable profit will be available against which the asset can be utilised. This requires judgements to be made in respect of the availability of future taxable income. No deferred tax asset or liability is recognised in respect of temporary differences associated with investments in subsidiaries and branches where the Company is able to control the timing of reversal of the temporary differences and it is probable that the temporary differences will not reverse in the foreseeable future. The Company’s deferred tax assets and liabilities are calculated using tax rates that are expected to apply in the period when the liability is settled or the asset realised based on tax rates that have been enacted or substantively enacted by the reporting date. Liabilities for uncertain tax positions require management to make judgements of potential exposures in relation to tax audit issues. Tax benefits are not recognised unless the tax positions will probably be accepted by the tax authorities. This is based upon management’s interpretation of applicable laws and regulations and the expectation of how the tax authority will resolve the matter. Once considered probable of not being accepted, management reviews each material tax benefit and reflects the effect of the uncertainty in determining the related taxable result. Liabilities for uncertain tax positions are measured using either the most likely amount or the expected value amount depending on which method the Company expects to better predict the resolution of the uncertainty. The Company has applied the exemption under the IAS 12 ‘Income Taxes’ amendment for recognising and disclosing information about deferred tax assets and liabilities related to top-up income taxes. Investments Fixed asset investments, including investments in subsidiaries, are stated at cost and reviewed for impairment if there are indications that the carrying value may not be recoverable. Debtors Amounts owed by Group undertakings are recognised initially at fair value. Subsequent to initial recognition they are measured at amortised cost using the effective interest method, less any impairment losses. The recoverability of these balances has been assessed in accordance with IFRS 9 and no impairment has been identified. The amounts owed by Group undertakings are considered to have low credit risk, due to timely payment of interest and settlement of principal amount on agreed due dates, limiting the loss allowance to 12-month expected credit losses. 218 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Amounts owed by Group undertakings are written off where there is no reasonable expectation of recovery. Impairment losses are presented as net impairment losses within Operating profit, any subsequent recoveries are credited against the same line. Other payables Liabilities included in Other payables are recognised initially at fair value. Subsequent to initial recognition they are remeasured at either amortised cost using the effective interest method or at fair value using an expected credit loss model. Financial instruments Interest-bearing loans are initially measured at fair value (with direct transaction costs being amortised over the life of the loan) and are subsequently measured at amortised cost using the effective interest method at each reporting date. Changes in carrying value are recognised in profit. Share-based payments The issuance by the Company to employees of its subsidiaries of a grant of awards over the Company’s shares, represents additional capital contributions by the Company to its subsidiaries. An additional investment in subsidiaries results in a corresponding increase in shareholders’ equity. The additional capital contribution is based on the fair value of the grant issued, allocated over the underlying grant’s vesting period, less the market cost of shares charged to subsidiaries in settlement of such share awards. Litigation Through the normal course of business, the AstraZeneca Group is involved in legal disputes, the settlement of which may involve cost to the Company. A provision is made where an adverse outcome is probable and associated costs, including related legal costs, can be estimated reliably. In other cases, appropriate disclosures are included. Company Accounting Policies AstraZeneca Annual Report & Form 20-F Information 2023 219 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Company Financial Statements 1 Fixed asset investments Investments in subsidiaries Shares Loans Total $m $m $m At 1 January 2022 49,581 16,043 65,624 Transfer to Debtors – amounts owed by Group undertakings – (1,531) (1,531) Capital reimbursement (380) – (380) Exchange – (161) (161) Amortisation – 12 12 Disposals and other movements (9) – (9) At 31 December 2022 49,192 14,363 63,555 Additions during the year – 1,588 1,588 Transfer to Debtors – amounts owed by Group undertakings – (991) (991) Capital reimbursement (131) – (131) Exchange – 158 158 Amortisation – 12 12 Other movements (2) – (2) At 31 December 2023 49,059 15,130 64,189 Loans to subsidiaries consists of bonds which are issued externally and are issued back to Group undertakings with comparable terms on interest rates and are repayable on maturity, details of which are disclosed in Note 3. The recoverability of these inter-company loans has been assessed in accordance with IFRS 9 with no impairment identified. The inter-company balances are considered to have low credit risk due to timely payment of interest and settlement of principal amount on agreed due dates, limiting the loss allowance to 12-month expected credit losses. In 2023, there have been no credit losses (2022: $nil). The other movements comprise $2m representing revaluation of carrying value of a guarantee provided to Group companies as explained in Notes 2 and 3. 2 Other payables 2023 2022 $m $m Amounts falling due within one year Other creditors 214 184 Deferred income 2 3 Amounts owed to Group undertakings – 7 216 194 Amounts falling due after more than one year Other creditors 21 23 21 23 Other creditors due after more than one year include an amount representing the carrying value of the guarantee provided by the Company to its subsidiary for the bonds issued externally as explained in Note 3. As at 31 December 2023, the carrying value of the guarantee was $21m (2022: $23m). 220 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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3 Loans and borrowings Repayment 2023 2022 dates $m $m Amounts due within one year Amounts owed to Group undertakings (unsecured) 7.2% Loan US dollars 2023 – 283 Interest-bearing loans and borrowings (unsecured) 0.3% Callable bond US dollars 2023 – 1,399 Floating rate notes US dollars 2023 – 400 3.5% Callable bond US dollars 2023 – 849 0.75% Callable bond euros 2024 995 – 2024 Floating rate bank loans US dollars 2024 2,000 – Total amounts due within one year 2,995 2,931 Amounts due after more than one year Interest-bearing loans and borrowings (unsecured) 0.75% Callable bond euros 2024 – 957 2024 Floating rate bank loans US dollars 2024 – 1,998 3.375% Callable bond US dollars 2025 1,994 1,992 0.7% Callable bond US dollars 2026 1,196 1,195 3.625% Callable bond euros 2027 829 – 3.125% Callable bond US dollars 2027 747 746 1.25% Callable bond euros 2028 879 845 4% Callable bond US dollars 2029 995 995 0.375% Callable bond euros 2029 881 846 1.375% Callable bond US dollars 2030 1,294 1,293 5.75% Non-callable bond pound sterling 2031 444 420 3.75% Callable bond euros 2032 827 – 6.45% Callable bond US dollars 2037 2,725 2,724 4% Callable bond US dollars 2042 989 988 4.375% Callable bond US dollars 2045 981 981 4.375% Callable bond US dollars 2048 738 737 2.125% Callable bond US dollars 2050 487 487 3% Callable bond US dollars 2051 735 735 Total amounts due after more than one year 16,741 17,939 Total loans and borrowings 19,736 20,870 2023 2022 $m $m Loans and borrowings are repayable: After five years from balance sheet date 11,096 11,051 From two to five years 3,651 3,933 From one to two years 1,994 2,955 Within one year 2,995 2,931 Total unsecured 19,736 20,870 All borrowings are issued with fixed interest rates, with the exception of the $2bn USD 2024 floating rate loans, which transitioned from LIBOR to a rate based on compounded daily USD Secured Overnight Funding Rate (SOFR) during the year. In addition, the Company acts as guarantor for bonds issued by its wholly owned subsidiaries, AstraZeneca Finance LLC and AstraZeneca Finance and Holdings Inc.. AstraZeneca Finance LLC is the issuer of $1,600m 0.700% Notes due 2024, $1,250m 1.200% Notes due 2026, $1,250m 1.750% Notes due 2028, $1,100m 4.875% Notes due 2028, $650m 4.900% Notes due 2030, $750m 2.250% Notes due 2031, and $500m 4.875% Notes due 2033 (the ‘AstraZeneca Finance Notes’) and AstraZeneca Finance and Holdings Inc., had a $2bn bank loan which was repaid during 2023. Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by the Company. Each of the guarantees issued by AstraZeneca PLC is full and unconditional and joint and several. The guarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC’s existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes. Notes to the Company Financial Statements AstraZeneca Annual Report & Form 20-F Information 2023 221 Strategic Report Corporate Governance Financial Statements Additional Information |
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Notes to the Company Financial Statements continued 4 Called-up share capital Details of share capital movements in the year are included in Note 24 to the Group Financial Statements. 5 Contingent liabilities The Company has guaranteed the external borrowing of a subsidiary in the amount of $nil (2022: $286m). Vermont US Attorney Investigation In April 2020, AstraZeneca received a Civil Investigative Demand from the US Attorney’s Office in Vermont and the Department of Justice, Civil Division, seeking documents and information relating to AstraZeneca’s relationships with electronic health-record vendors. AstraZeneca is cooperating with this enquiry. AZD1222 Securities Litigation In January 2021, putative securities class action lawsuits were filed in the US District Court for the Southern District of New York (District Court) against AstraZeneca PLC and certain officers, on behalf of purchasers of AstraZeneca publicly traded securities during a period later amended to cover 15 June 2020 through 29 January 2021. The Amended Complaint alleges that defendants made materially false and misleading statements in connection with the development of AZD1222, AstraZeneca’s vaccine for the prevention of COVID-19. In September 2022, the District Court granted AstraZeneca’s motion to dismiss the Amended Complaint with prejudice. In May 2023, the US Court of Appeals for the Second Circuit affirmed the dismissal. The matter is now concluded. 6 Statutory and other information The Directors of the Company were paid by another Group company in 2023 and 2022. 7 Subsequent events There were no material subsequent events. 222 AstraZeneca Annual Report & Form 20-F Information 2023 Financial Statements |
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Group Financial Record 2019 2020 2021 2022 2023 For the year ended 31 December $m $m $m $m $m Revenue and profits Product Sales 23,565 25,890 36,541 42,998 43,789 Alliance Revenue 62 190 388 755 1,428 Collaboration Revenue 757 537 488 598 594 Cost of sales (4,921) (5,299) (12,437) (12,391) (8,268) Distribution expense (339) (399) (446) (536) (539) Research and development expense (6,059) (5,991) (9,736) (9,762) (10,935) Selling, general and administrative expense (11,682) (11,294) (15,234) (18,419) (19,216) Other operating income and expense 1,541 1,528 1,492 514 1,340 Operating profit 2,924 5,162 1,056 3,757 8,193 Finance income 172 87 43 95 344 Finance expense (1,432) (1,306) (1,300) (1,346) (1,626) Share of after tax losses in associates and joint ventures (116) (27) (64) (5) (12) Profit/(loss) before tax 1,548 3,916 (265) 2,501 6,899 Taxation (321) (772) 380 792 (938) Profit for the period 1,227 3,144 115 3,293 5,961 Other comprehensive income/(expense) for the period, net of tax (611) 1,608 (145) (878) 733 Total comprehensive income/(expense) for the period 616 4,752 (30) 2,415 6,694 Profit attributable to: Owners of the Parent 1,335 3,196 112 3,288 5,955 Non-controlling interests (108) (52) 3 5 6 Earnings per share Basic earnings per $0.25 Ordinary Share $1.03 $2.44 $0.08 $2.12 $3.84 Diluted earnings per $0.25 Ordinary Share $1.03 $2.44 $0.08 $2.11 $3.81 Dividends $2.80 $2.80 $2.80 $2.90 $2.90 Group Financial Record AstraZeneca Annual Report & Form 20-F Information 2023 223 Strategic Report Corporate Governance Financial Statements Additional Information |
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Contents Shareholder information 225 Directors’ Report 227 Sustainability supplementary information 230 Trade Marks 231 Glossary 232 Cautionary statement regarding forward-looking statements 236 Additional Information 224 AstraZeneca Annual Report & Form 20-F Information 2023 Additional Information |
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This section of the Annual Report contains information for shareholders that is required by regulation in the UK. Further information that may be of use to shareholders is available on the Shareholder information page of our website at www.astrazeneca.com. Additional information required by SEC regulations is included in AstraZeneca’s Form 20-F filing for 2023, which is available on the SEC website at www.sec.gov. The principal markets for trading in AstraZeneca shares are the London Stock Exchange, Nasdaq Stockholm and the Nasdaq Global Select Market (Nasdaq). AstraZeneca shares were listed on Nasdaq on 25 September 2020, prior to which they were listed on the New York Stock Exchange. Ordinary Shares of $0.25 each in AstraZeneca PLC are listed on the London Stock Exchange and the shareholder register is maintained by Equiniti Limited, the Ordinary Share registrar. Shares listed on Nasdaq Stockholm are issued under the Euroclear Services Agreement by Euroclear Sweden AB, the Swedish Central Securities Depositary. Shares listed on Nasdaq are in the form of American Depositary Shares (ADSs), evidenced by American Depositary Receipts (ADRs) issued by the Company’s ADR depositary, Deutsche Bank Trust Company Americas (Deutsche Bank). Two ADSs are equivalent to one Ordinary Share. Before 27 July 2015, the ratio was one ADS per one Ordinary Share. Shares are listed on all three markets under the stock symbol AZN. Ordinary Share registrar Equiniti Limited Aspect House Spencer Road Lancing West Sussex BN99 6DA UK Tel (freephone in UK): +44 (0)800 389 1580 Swedish Central Securities Depositary Euroclear Sweden AB PO Box 191 SE-101 23 Stockholm Sweden Tel: +46 (0)8 402 9000 ADR depositary Deutsche Bank Trust Company Americas c/o Equiniti Trust Company, LLC 6201 15th Avenue Brooklyn NY 11219 USA Tel (toll free in the US): +1 (888) 697 8018 Tel (outside US): +1 (718) 921 8137 adr@equiniti.com Annual General Meeting (AGM) The 2024 AGM will be held on 11 April 2024 and further details will be set out in the Notice of Meeting. If you hold shares listed on Nasdaq Stockholm or hold ADRs, information relating to voting and participation will be included in the relevant Notice of AGM. If you hold your shares through a nominee, your nominee provider will be able to advise you of their arrangements in relation to voting and participation. Dividends Dividend dates for 2024 are shown in the financial calendar below. A first interim dividend is normally announced in July/August and paid in September and a second interim dividend is normally announced in January/ February and paid in March. Dividends are paid in GBP, SEK and USD, depending on where the eligible shares are listed. Financial calendar Event Provisional date Second interim dividend for 2023 Ex-dividend date 22 February 2024 Record date 23 February 2024 Payment date 25 March 2024 Annual General Meeting (AGM) 11 April 2024 Announcement of first quarter results for 2024 25 April 2024 Announcement of second quarter and half-year results for 2024 25 July 2024 First interim dividend for 2024 Ex-dividend date 8 August 2024 Record date 9 August 2024 Payment date 9 September 2024 Announcement of third quarter results for 2024 12 November 2024 Financial year end 31 December 2024 Related party transactions During the period 1 January 2024 to 31 January 2024, there were no transactions, loans, or proposed transactions between the Company and any related parties which were material to either the Company or the related party, or which were unusual in their nature or conditions (see also Note 31 to the Financial Statements on page 210). Conflicts of interest The Articles enable the Directors to authorise any situation in which a Director has an interest that conflicts or has the potential to conflict with the Company’s interests and which would otherwise be a breach of the Director’s duty, under section 175 of the Companies Act 2006. The Board has a formal system in place for Directors to declare such situations to be considered for authorisation by those Directors who have no interest in the matter being considered. In deciding whether to authorise a situation, the non-conflicted Directors must act in the way they consider, in good faith, would be most likely to promote the success of the Company, and they may impose limits or conditions when giving the authorisation, or subsequently, if they think this is appropriate. Situations considered by the Board and authorisations given are recorded in the Board minutes and in a register of conflicts maintained by the Company Secretary and are reviewed annually by the Board. The Board believes that this system operates effectively. Shareholder fraud warning Shareholders of AstraZeneca and many other companies have reported receiving unsolicited calls and correspondence relating to their shareholdings and investment matters. Shareholders are advised to be very cautious of any unsolicited approaches and to note that reputable firms authorised by the Financial Conduct Authority (FCA) are very unlikely to make such approaches. Such approaches are likely to be part of a ‘boiler room scam’ attempting to defraud shareholders. Shareholders are advised to familiarise themselves with the information on scams available on the FCA website, www.fca.org.uk/consumers and within the FAQs in the Investors section of our website, www.astrazeneca.com. Any suspected scams or fraudulent approaches should be reported to the FCA via its website and to AstraZeneca’s Ordinary Share registrar, using the contact details on this page. For further information on dividends declared, see the Shareholder information section of our website, www.astrazeneca.com. AstraZeneca Annual Report & Form 20-F Information 2023 225 Strategic Report Corporate Governance Financial Statements Additional Information Shareholder information Shareholder information |
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Issued share capital, shareholdings and share prices At 31 December 2023, the Company had 66,385 registered holders of 1,550,162,626 Ordinary Shares. There were 168,456 holders of Ordinary Shares held under the Euroclear Services Agreement, representing 10.4% of the issued share capital of the Company and 1,595 registered holders of ADSs, representing 18.7% of the issued share capital of the Company. Ordinary Shares in issue 2023 2022 2021 Ordinary Shares in issue – millions At year-end 1,550 1,550 1,549 Weighted average for year 1,549 1,548 1,418 Stock market closing price per Ordinary Share (London Stock Exchange) Highest (pence) 12294 11440 9444 Lowest (pence) 9900 8282 6794 At year end (pence) 10600 11218 8678 Analysis of shareholdings as a percentage of issued share capital at 31 December Number of Ordinary Shares1 2023 % 2022 % 2021 % 1-250 0.3 0.3 0.3 251-500 0.3 0.3 0.3 501-1,000 0.4 0.4 0.4 1,001-5,000 0.5 0.5 0.6 5,001-10,000 0.2 0.2 0.2 10,001-50,000 1.1 1.1 1.1 50,001-1,000,000 11.3 1.1 1.1 Over 1,000,000 85.9 96.1 96.0 1 Includes Euroclear and ADR holdings. US holdings At 31 January 2024, the proportion of Ordinary Shares represented by ADSs was 18.7% of the issued share capital of the Company. At 31 January 2024, there were 66,104 registered holders of Ordinary Shares, of which 609 were based in the US and there were 1,588 record holders of ADRs, of which 1,571 were based in the US. Exchange controls and other limitations affecting security holders Other than certain economic sanctions, which may be in force from time to time, there are no governmental laws, decrees or regulations in the UK restricting the import or export of capital or affecting the remittance of dividends, interest or other payments to non-resident holders of Ordinary Shares or ADRs. Other than certain economic sanctions, which may be in force from time to time, there are no limitations under English law or the Articles on the right of non-resident or foreign owners to be the registered holders of, or to exercise voting rights in relation to, Ordinary Shares or ADRs or to be registered holders of notes or debentures of the Company or its wholly owned subsidiaries, Zeneca Wilmington Inc. and AstraZeneca Finance LLC. Information on the Company’s share price, including historical closing prices and volumes, and an interactive share price graph can be found on the Investor Relations section on our website, www.astrazeneca.com. 226 AstraZeneca Annual Report & Form 20-F Information 2023 Additional Information Shareholder information continued |
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The Directors’ Report includes information required to be given in accordance with the Companies Act 2006. Relevant information below, which is contained elsewhere in the Annual Report, is incorporated by cross reference herein. Subsidiaries and principal activities The Company is the holding company for a group of subsidiaries whose principal activities are described in this Annual Report. The Group’s subsidiaries and their locations are set out in Group Subsidiaries and Holdings in the Financial Statements from page 211. Branches and countries in which the Group conducts business In accordance with the Companies Act 2006, we disclose below countries of our representative, scientific or branch offices outside the UK established through various subsidiaries of the Company: Algeria, Angola, Costa Rica, Cuba, Denmark, Egypt, Georgia, Ghana, Jordan, Lebanon, Norway, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, Syria, Ukraine, United Arab Emirates, the US and Vietnam. Disclosure of information to auditors The Directors who held office at the date of approval of this Annual Report confirm that, so far as they are each aware, there is no relevant audit information of which the Company’s auditors are unaware; and each Director has taken all the steps that he or she ought to have taken as a Director to make himself or herself aware of any relevant audit information and to establish that the Company’s auditors are aware of that information. Going concern accounting basis Information on the business environment in which AstraZeneca operates, including the factors underpinning the industry’s future growth prospects, is included in the Strategic Report. Details of the product portfolio of the Group are contained in the Strategic Report (in the Therapy Area Review from page 16). For information on patent expiry dates for key marketed products, see the Patent Expiries of Key Marketed Products Supplement on our website, www.astrazeneca.com/ annualreport2023. Our approach to product development is covered in detail with additional information by Therapy Area in the Strategic Report. For information on our development pipeline, see the Development Pipeline Supplement on our website, www.astrazeneca.com/annualreport2023. The financial position of the Group, its cash flows, liquidity position and borrowing facilities are described in the Financial Review from page 58. In addition, Note 28 to the Financial Statements from page 195 includes the Group’s objectives, policies and processes for: managing capital; financial risk management objectives; details of its financial instruments and hedging activities; and its exposures to credit, market and liquidity risk. Further details of the Group’s cash balances and borrowings are included in Notes 17 and 19 to the Financial Statements from page 178. Having assessed the Principal Risks and other matters considered in connection with the Viability statement on page 55, the Board considers it appropriate to adopt the going concern basis of accounting in preparing the Annual Report and Financial Statements. Shares A shareholders’ resolution was passed at the 2023 AGM authorising the Company to purchase its own shares. The Company did not purchase any of its own shares in 2023. On 31 December 2023, the Company did not hold any shares in treasury. Rights, preferences and restrictions attaching to shares As at 31 December 2023, the Company had 1,550,162,626 Ordinary Shares and 50,000 Redeemable Preference Shares in issue. The Ordinary Shares represent 99.98% and the Redeemable Preference Shares represent 0.02% of the Company’s total share capital (these percentages have been calculated by reference to the 8am WM/Reuters USD/GBP exchange rate on 29 December 2023). As agreed by the shareholders at the Company’s AGM held on 29 April 2010, the Articles were amended with immediate effect to remove the requirement for the Company to have an authorised share capital, the concept of which was abolished under the Companies Act 2006. Each Ordinary Share carries the right to vote at general meetings of the Company. The rights and restrictions attaching to the Redeemable Preference Shares differ from those attaching to Ordinary Shares as follows: > The Redeemable Preference Shares carry no rights to receive dividends. > The holders of Redeemable Preference Shares have no rights to receive notices of, attend or vote at general meetings except in certain limited circumstances. They have one vote for every 50,000 Redeemable Preference Shares held. > On a distribution of assets of the Company, on a winding-up or other return of capital (subject to certain exceptions), the holders of Redeemable Preference Shares have priority over the holders of Ordinary Shares to receive the capital paid up on those shares. > Subject to the provisions of the Companies Act 2006, the Company has the right to redeem the Redeemable Preference Shares at any time on giving not less than seven days’ written notice. There are no specific restrictions on the transfer of shares in the Company, which is governed by the Articles and prevailing legislation. The Company is not aware of any agreements between holders of shares that may result in restrictions on the transfer of shares or that may result in restrictions on voting rights. The Company is also not aware of any arrangements under which financial rights are held by a person other than the holder of the shares. Action necessary to change the rights of shareholders In order to vary the rights attached to any class of shares, the consent in writing of the holders of three quarters in nominal value of the issued shares of that class or the sanction of a special resolution passed at a general meeting of such holders is required. Changes in share capital Changes in the Company’s Ordinary Share capital during 2023, including details of the allotment of new shares under the Company’s share plans, are given in Note 24 to the Financial Statements from page 192. Employee share trust ownership rights The trustee of the AstraZeneca Employee Benefit Trust (the EBT, the Trustee) will not exercise voting rights attached to shares held in the EBT (Shares). Any decision as to acceptance or rejection of an offer for Shares subject to subsisting awards would be made by the Trustee, having regard to the interests of award holders. During 2023, a further employee benefit trust was established for the benefit of employees based in Canada (the Canada EBT). The trustees of the Canada EBT will not exercise voting rights attached to shares held in the Canada EBT. For more information on shares, see Issued share capital, shareholdings and share prices on page 226. AstraZeneca Annual Report & Form 20-F Information 2023 227 Strategic Report Corporate Governance Financial Statements Additional Information Directors’ Report Directors’ Report |
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Directors’, officers’ and SET shareholdings At 31 January 2024, the total amount of the Company’s voting securities owned by Directors and officers of the Company and other SET members was: Title of class Amount owned Percentage of class Ordinary Shares 804,434 0.05% Options to purchase securities from registrant or subsidiaries (a) At 31 January 2024, options outstanding to subscribe for Ordinary Shares were: Number of shares Subscription price (pence) Normal expiry date 1,176,592 3597-9064 2023-2029 The weighted average subscription price of options outstanding at 31 January 2024 was 7086 pence. All options were granted under Company employee share schemes. (b) None of the options included in paragraph (a) have been granted to officers of the Company and SET members. (c) During 2023, no options were held by Directors. During the period 1 January 2024 to 31 January 2024, no Director was granted or exercised any options. Distributions to shareholders – dividends for 2023 Details of our distribution policy are set out in the Financial Review from page 58 and Note 28 to the Financial Statements from page 195. The Company’s dividend for 2023 of $2.90 (227.8 pence, 30.29 SEK) per Ordinary Share is estimated to amount to, in aggregate, a total dividend payment to shareholders of $4,494 million. Two employee share trusts, AstraZeneca EBT and AstraZeneca Share Trust Limited, waived their rights to a dividend on the Ordinary Shares they hold and instead received nominal dividends. Articles of Association AstraZeneca PLC’s current Articles were adopted by shareholders at the Company’s AGM held on 27 April 2023. Any amendment to the Articles requires the approval of shareholders by a special resolution at a general meeting of the Company. Objects The Company’s objects are unrestricted. Directors The Board has the authority to manage the business of the Company, for example, through powers to allot and repurchase its shares, subject where required to shareholder resolutions. Subject to certain exceptions, Directors do not have power to vote at Board meetings on matters in which they have a material interest. The quorum for meetings of the Board is a majority of the full Board, of whom at least four must be Non-Executive Directors. In the absence of a quorum, the Directors do not have power to determine compensation arrangements for themselves or any member of the Board. The Board may exercise all the powers of the Company to borrow money. Variation of these borrowing powers would require the passing of a special resolution of the Company’s shareholders. All Directors must retire from office at the Company’s AGM each year and may present themselves for election or re-election. Directors are not prohibited, upon reaching a particular age, from submitting themselves for election or re-election. General meetings AGMs require 21 clear days’ notice to shareholders. Subject to the Companies Act 2006, other general meetings require 14 clear days’ notice. For all general meetings, a quorum of two shareholders present in person or by proxy, and entitled to vote on the business transacted, is required unless each of the two persons present is a corporate representative of the same corporation, or each of the two persons present is a proxy of the same shareholder. Major shareholdings At 31 December 2023, the following persons had disclosed an interest in the issued Ordinary Share capital of the Company in accordance with the requirements of rules 5.1.2 or 5.1.5 of the UK Listing Authority’s Disclosure Guidance and Transparency Rules. Changes in the percentage ownerships disclosed by major shareholders are set out below. Major shareholders do not have different voting rights. Number of Ordinary Shares disclosed as a percentage of issued share capital at: Shareholder Date of the latest disclosure to the Company1 Number of Ordinary Shares disclosed Date of the latest disclosure to the Company 31 December 2021 31 December 2022 31 December 2023 31 January 2024 BlackRock, Inc. 4 December 2009 100,885,181 6.96 6.51 6.51 6.51 6.51 Investor AB 3 April 2019 51,587,810 3.93 3.33 3.33 3.33 3.33 The Capital Group Companies, Inc. 17 July 2018 63,802,495 5.04 4.12 4.12 4.12 4.12 Wellington Management Group LLP2 21 July 2020 65,120,892 4.96 4.20 4.20 4.20 4.20 Wellington Management Company LLP2 21 July 2020 65,118,411 4.96 4.20 4.20 4.20 4.20 1 Since the date of disclosure to the Company, the interest of any person listed above in Ordinary Shares may have increased or decreased. No requirement to notify the Company of any increase or decrease arises unless the holding passes a notifiable threshold in accordance with rules 5.1.2 or 5.1.5 of the UK Listing Authority’s Disclosure Guidance and Transparency Rules. 2 The Company was notified at the time of the disclosure that Wellington Management Company LLP was a subsidiary of Wellington Management Group LLP and that the shareholding percentage notified by Wellington Management Company LLP was included within the aggregate shareholding percentage notified by Wellington Management Group LLP. So far as the Company is aware, no other person held a notifiable interest in the issued Ordinary Share capital of the Company. No changes to major shareholdings were disclosed to the Company between 31 December 2023 and 31 January 2024. So far as the Company is aware, it is neither directly nor indirectly owned or controlled by one or more corporations or by any government. The Company does not know of any arrangements, the operation of which might result in a change in the control of the Company. For more information on dividend distribution, the AGM and results announcements, see Financial calendar on page 225. For more information on the Directors, see Board of Directors on pages 78 and 79. 228 AstraZeneca Annual Report & Form 20-F Information 2023 Additional Information Directors’ Report continued |
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Shareholders and their duly appointed proxies and corporate representatives are entitled to be admitted to general meetings. Limitations on the rights to own shares There are no limitations on the rights to own shares. Gender diversity Directors of the Company’s subsidiaries* Men (60%) 237 Women (40%) 161 Total 398 Senior Executive Team* Men (58%) 7 Women (42%) 5 Total 12 All numbers as at 31 December 2023. * For the purposes of section 414C(8)(c)(ii) of the Companies Act 2006, ‘Senior Managers’ are the Senior Executive Team (SET), the Directors of all of the subsidiaries of the Company and other individuals holding named positions within those subsidiaries. Individuals on multiple boards are counted once. Stakeholder engagement The discussion on stakeholder engagement and the impact of these interactions is contained in Connecting with our stakeholders from page 84 and throughout the Strategic Report. This includes engagement with our employees, suppliers and other stakeholders, as well as the impact of our operations on the community and environment. Information on how we encourage employee involvement in the Company’s performance is set out in People and Sustainability from page 43. Details of some of the employee share plans are described in the Directors’ Remuneration Report from page 102, and in Note 29 to the Financial Statements from page 201. All employees are provided with information on matters of concern to them through regular meetings and updates on the Group’s intranet and internal social media. ‘Townhall’ meetings and Q&A sessions are hosted regularly by members of senior management, including the SET, including global and targeted broadcasts on internal social media. During 2023, these broadcasts provided updates on the business, including pipeline developments and leadership changes, as well as the Group’s response to global issues such as climate change. In addition, information about the Group’s quarterly results is shared with employees. These updates inform employees of the financial and economic factors which affect the performance of the Group. Political donations Neither the Company nor its subsidiaries made any EU political donations or incurred any EU political expenditure in 2023 and they do not intend to do so in the future in respect of which shareholder authority is required, or for which disclosure in this Annual Report is required, under the Companies Act 2006. However, to enable the Company and its subsidiaries to continue to support interest groups or lobbying organisations concerned with the review of government policy or law reform without inadvertently breaching the Companies Act 2006, which defines political donations and other political expenditure in broad terms, a resolution will be put to shareholders at the 2024 AGM, similar to that passed at the 2023 AGM, to authorise the Company and its subsidiaries to: > make donations to political parties or independent election candidates > make donations to political organisations other than political parties > incur political expenditure, up to an aggregate limit of $250,000. Corporate political contributions in the US are permitted in defined circumstances under the First Amendment of the US Constitution and are subject to both federal and state laws and regulations. In 2023, the Group’s US legal entities made contributions amounting in aggregate to $1,687,650 (2022: $1,316,950) to national political organisations, state-level political party committees and to campaign committees of various state candidates. No corporate political donations were made at the federal level and all contributions were made only where allowed by US federal and state law. We publicly disclose details of our corporate US political contributions, which can be found on our website, www.astrazeneca-us.com/sustainability/ corporate-transparency. The annual corporate contributions budget is reviewed and approved by the US Vice-President, Corporate Affairs and the President of our US business to ensure robust governance and oversight. US citizens or individuals holding valid green cards exercised decision making over the contributions and the funds were not provided or reimbursed by any non-US legal entity. Such contributions do not constitute political donations or political expenditure for the purposes of the Companies Act 2006 and were made without any involvement of persons or entities outside the US. Significant agreements There are no significant agreements to which the Company is a party that take effect, alter or terminate on a change of control of the Company following a takeover bid. There are no persons with whom we have contractual or other arrangements, who are deemed by the Directors to be essential to our business. Use of financial instruments The Notes to the Financial Statements, including Note 28 from page 195, include further information on our use of financial instruments. Insurance and indemnities The Company maintained directors’ and officers’ liability insurance cover throughout 2023. The Directors are also able to obtain independent legal advice at the expense of the Company, as necessary, in their capacity as Directors. The Company has entered into a deed of indemnity in favour of each Board member since 2006. These deeds of indemnity are still in force and provide that the Company shall indemnify the Directors to the fullest extent permitted by law and the Articles, in respect of all losses arising out of, or in connection with, the execution of their powers, duties and responsibilities as Directors of the Company or any of its subsidiaries. This is in line with current market practice and helps us attract and retain high-quality, skilled Directors. Compliance requirements under Listing Rule 9.8.4 The only matter to report is the shareholder waiver of dividends on page 228. Directors’ Report The Directors’ Report, which has been prepared in accordance with the requirements of the Companies Act 2006, comprises the following sections: > Chair’s Statement > Chief Executive Officer’s Review > Therapy Area Review > Business Review > Risk Overview > Financial Review: Financial risk management > Corporate Governance: including the Corporate Governance Overview, Corporate Governance Report, Nomination and Governance Committee Report, Science Committee Report, Sustainability Committee Report and Audit Committee Report > Directors’ responsibility statement > Shareholder information > Sustainability supplementary information and has been approved by the Board and signed on its behalf. On behalf of the Board A C N Kemp Company Secretary 8 February 2024 AstraZeneca Annual Report & Form 20-F Information 2023 229 Strategic Report Corporate Governance Financial Statements Additional Information Directors’ Report |
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External assurance Bureau Veritas has provided independent external assurance to a limited level on the following sustainability information contained within this Annual Report: > Positively impacting people, society and the planet see page 5. > People and Sustainability, Key Performance Indicators, see page 15. > Bioethics, including Clinical trial transparency, Research use of human biological samples and genomic information, and Animals in research, see page 36. > Healthcare in low- and middle-income countries, see page 39. > Responsible sales and marketing, see page 39. > Anti-bribery and anti-corruption, see page 39. > Responsible supply chain, see page 40. > People and Sustainability, see page 43. > Human rights, see page 45. > Employee relations, see page 45. > Workforce safety and health, see page 45. > Sustainability, including Overview, Our approach to sustainability, Governance, Benchmarking and assurance, and Sustainability strategy, see page 46. > Access to healthcare, including Equitable access, Affordability and pricing, and Health system resilience, see page 47. > Environmental protection, including Ambition Zero Carbon, Product sustainability, and Natural resources, see page 48. > Ethics and transparency, including Code of Ethics, see page 49. > EU Taxonomy Disclosure, see page 50. > Task Force on Climate-related Financial Disclosures Summary Statement, see pages 51 to 53. See our full TCFD Statement on our website, www.astrazeneca.com/annualreport2023. > GHG reporting, see this page. BV Used throughout this Annual Report to denote the sustainability information listed above, which has been independently assured by Bureau Veritas. Based on the evidence provided and subject to the scope, objectives and limitations defined in the full assurance statement, nothing has come to the attention of Bureau Veritas causing them to believe that the sustainability information contained within this Annual Report is materially misstated. Bureau Veritas is a professional services company that has a long history of providing independent assurance services in environmental, health, safety, social and ethical management and disclosure. The full assurance statement, which includes Bureau Veritas’ scope of work, methodology, overall opinion, and limitations and exclusions, is available on our website, www.astrazeneca.com/ sustainability/resources.html. GHG reporting BV We have reported on all of the emission sources required under the Streamlined Energy and Carbon Reporting (SECR). These sources fall within our Consolidated Financial Statements. We do not have responsibility for any emission sources that are not included in our Consolidated Financial Statements. Global GHG emissions data for the period 1 January 2023 to 31 December 20231 Tonnes CO2e 2023 2022 2021 Emissions from: Scope 1: Combustion of fuel and operation of facilities2,5 180,898 237,703 239,468 Scope 2 (Market-based): Electricity (net of market instruments), heat, steam and cooling purchased for own use3,5 19,940 18,491 21,135 Scope 2 (Location-based): Electricity, heat, steam and cooling purchased for own use3,5 183,332 180,403 189,395 Company’s chosen intensity measurement: Scope 1 + Scope 2 (Market-based) emissions reported above normalised to million US dollar revenue 4.38 5.78 6.39 Scope 3 Total: Emissions from all 15 GHG Protocol Scope 3 Categories 6,736,878 6,167,415 5,925,850 Scope 3 intensity measurement: Scope 3 emissions from all 15 GHG Protocol Scope 3 Categories normalised to million US dollar revenue 147.06 139.06 145.41 MegaWatt hours (MWh) Total energy consumption4,5 1,511,334 1,568,815 1,667,765 1 Regular review of the data is carried out to ensure accuracy, consistency and reflect major business change. This has led to changes in data in previous years. The majority of the adjustments made are not material individually, except for (i) Scope 1: Combustion of fuel and operations facilities, (ii) Scope 2 (Location-based): Electricity, heat, steam and cooling purchased for own use, (iii) Company’s chosen intensity measurement: Scope 1 + Scope 2 (Market-based) emissions reported above normalised to million US dollar revenue, as a result of a divestment in manufacturing facility, update to using IPCC AR5 Global Warming Potentials (GWPs) from IPCC AR4 GWPs for calculating process, fugitive and solvent emissions and reporting of fuel volume in US & EUCAN to represent business activity. Additionally (iv) Total energy consumption data that has also changed. For (v) most material changes are: Scope 3 Category 1 purchased goods and services (methodology updated to exclude spend based emissions associated with royalty payments); (vi) Scope 3 Category 8 upstream leased assets (methodology updated to calculate GHG emissions in leased office space based on internal benchmark for office space energy consumption from mixed-use space); (vii) Scope 3 Category 11 use of sold products (methodology update to reflect IPCC AR5 GWPs from AR4 GWPs for calculating emissions associated with the patient use of sold inhalation products); and (viii) Scope 3 Category 12 end of life treatment of sold products (methodology updated to reflect GHG emissions accounted for in Scope 3 Category 11 use of sold products and remove double counting of GHG emissions). 2 Included in this section are GHGs from direct fuel combustion, process and engineering emissions at our sites and from fuel use in our vehicle fleet. 3 GHGs from imported electricity are calculated using the GHG Protocol Scope 2 Guidance (January 2015) requiring dual reporting using two emissions factors for each site – Market-based and Location-based. Our corporate emissions reporting and targets follow the Market-based approach. We have used the GHG Protocol Corporate Accounting and Reporting Standard (revised edition). Emission factors for electricity have been derived from the International Energy Agency, USEPA eGRID, US Green-e and the Association of Issuing Bodies databases and for all other fuels and emission sources from the 2006 IPCC Guidelines for National Greenhouse Gas Inventories. 4 The aggregate of: (i) the annual quantity of energy consumed from activities for which the Company is responsible, including the combustion of fuel at a facility or the operation of any facility; and (ii) the annual quantity of energy consumed resulting from the purchase of electricity, heat, steam or cooling by the Company for its own use. 5 Under the Companies (Directors’ Report) and Limited Liability Partnerships (Energy and Carbon Report) Regulations 2018, the Company needs to disclose what proportion of this figure relates to energy use in the UK and offshore area. For 2023, the proportion of total global energy and emissions originating from AstraZeneca’s UK and offshore area footprint were as follows: energy use 295 GWh (20%); Scope 1 site energy and road fleet emissions 28 ktCO2e (14%); Scope 2 site imported energy emissions using Market-based accounting 0 ktCO2e (0%) and Scope 2 site imported energy emissions using Location‑based accounting 17 ktCO2e (9%). In the period covered by the report AstraZeneca has installed LED lighting, upgraded chillers, improved controls for heating, ventilation and air conditioning systems, continued improvements for the combined heat and power plant, and maintained ISO 50001 certification at the Macclesfield facility, UK. At the manufacturing site in Liverpool, UK new efficient electric steam boilers have been installed. 230 AstraZeneca Annual Report & Form 20-F Information 2023 Additional Information Sustainability supplementary information For more information, see Environmental protection from page 48. For more information, see our Sustainability Report on our website, www.astrazeneca.com/ sustainability. |
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AstraZeneca, the AstraZeneca logotype, and the AstraZeneca symbol are all trade marks of the Group. The following medicine names which appear in italics in this Annual Report are trade marks of the Group: Trade mark Airsupra Daliresp Lokelma Strensiq Andexxa Daxas Lumoxiti Symbicort Arimidex1 Epanova Lynparza Symbicort Turbuhaler Atacand2 Evusheld Movantik Symlin Atacand HCT Farxiga Moventig Synagis5 Atacand Plus2 Fasenra Nexium Tagrisso BCise Faslodex Ondexxya Toprol-XL Betaloc Fluenz Onglyza Trixeo Bevespi Aerosphere FluMist Orpathys Trixeo Aerosphere Breztri Forxiga Plendil3 Truqap Breztri Aerosphere Genuair Prilosec Turbuhaler Brilinta Imfinzi Pulmicort Ultomiris Brilique Imjudo Pulmicort Flexhaler Vaxzevria Bydureon Iressa Qtern Vimovo6 Byetta Kanuma Saphnelo Voydeya Calquence Kombiglyze Seloken Wainua Casodex1 Komboglyze Seroquel4 Xigduo Cosudex Koselugo Seroquel XR4 Zoladex Crestor Losec4 Soliris 1 AstraZeneca divested these trade marks in a number of European, African and other markets to Juvisé Pharmaceuticals effective 19 December 2019. 2 AstraZeneca divested these trade marks in Europe to Cheplapharm effective 28 September 2018, and in more than 70 other markets effective 31 December 2020. 3 Effective 18 May 2022, AstraZeneca divested Plendil in 35 markets to Glenwood. 4 AstraZeneca divested these trade marks in Europe and Russia to Cheplapharm effective 13 December 2019. 5 Effective 25 January 2019, AstraZeneca sold its rights to Synagis in the US to Sobi. AbbVie Inc. transferred its ownership rights to this trademark to MedImmune LLC, effective 1 July 2021. 6 AstraZeneca divested the global rights (excluding the US and Japan) for this trade mark to Grünenthal Group, effective 3 December 2018. The following medicine names, which appear in italics in this Annual Report, are trade marks licensed to the Group by the entities set out below: Trade mark Licensor or Owner Anticalin Pieris AG Beyfortus Sanofi Pasteur Inc. Duaklir Almirall, S.A. Eklira Almirall, S.A. Enhertu Daiichi Sankyo Company, Limited Linzess Ironwood Pharmaceuticals, Inc. Tezspire Amgen Inc. Tudorza Almirall, S.A. The following medicine names, which appear in italics in this Annual Report, are not owned by or licensed to the Group and are owned by the entities set out below: Trade mark Owner messenger RNA Therapeutics Moderna Covishield Serum Institute of India AstraZeneca Annual Report & Form 20-F Information 2023 231 Strategic Report Corporate Governance Financial Statements Additional Information Trade Marks Trade Marks |
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Market definitions1 Region Country US US Europe Austria* Estonia* Ireland* Netherlands Slovenia* Belgium Finland Israel* Norway Spain Bulgaria* France Italy Poland Sweden Croatia Germany Latvia* Portugal* Switzerland Cyprus* Greece Lithuania* Romania UK Czech Republic Hungary Luxembourg* Serbia and Montenegro* Denmark Iceland* Malta* Slovakia* Established RoW Australia Canada Japan New Zealand* Emerging Markets Algeria Dominican Republic Kazakhstan Panama Tunisia* Argentina Ecuador* Kuwait Peru Turkey Aruba* Egypt Lebanon* Philippines Ukraine Bahamas* El Salvador Libya* Qatar* United Arab Emirates Bahrain* Georgia* Malaysia Russia Uruguay* Barbados* Guatemala Maldives Saudi Arabia Uzbekistan Belarus* Honduras Mexico Singapore Venezuela* Brazil Hong Kong Mongolia South Africa Vietnam* Brunei India Morocco* South Korea Yemen* Cambodia Indonesia Nicaragua Sri Lanka* Chile Iran* Oman* Sudan* China Iraq* Other Africa* Taiwan Colombia Jamaica* Pakistan* Thailand Costa Rica Jordan Palestine* Trinidad and Tobago* * Q3 2023 IQVIA, IQVIA Midas Quantum Q3 2023 data are not available or AstraZeneca does not subscribe for IQVIA quarterly data for these countries. 1 The above table is not an exhaustive list of all the countries in which AstraZeneca operates, and excludes countries with revenue in 2023 of less than $1 million. Established Markets means US, Europe and Established RoW. North America means US. Other Emerging Markets means all Emerging Markets except China. Other Africa includes Botswana, Ghana, Kenya, Mauritius, Namibia and Nigeria. US equivalents Terms used in this Annual Report US equivalent or brief description Accruals Accrued expenses Called-up share capital Issued share capital Earnings Net income Employee share schemes Employee stock benefit plans Fixed asset investments Non-current investments Freehold Ownership with absolute rights in perpetuity Loans Long-term debt Prepayments Prepaid expenses Profit Income Share premium account Additional paid-in capital or paid-in surplus (not distributable) Short-term investments Redeemable securities and short-term deposits Trade Payables Accounts payable Trade Receivables Accounts receivable 232 AstraZeneca Annual Report & Form 20-F Information 2023 Additional Information Glossary |
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The following abbreviations and expressions have the meanings given below when used in this Annual Report: Acerta – Acerta Pharma B.V. ADC(s) – antibody drug conjugate(s). ADRs – American Depositary Receipts. ADSs – American Depositary Shares. AGM – Annual General Meeting of the Company. AI – artificial intelligence. AKT1 – serine/threonine protein kinase 1. Alexion – Alexion Pharmaceuticals, Inc. Almirall – Almirall, S.A. Amgen – Amgen Inc. Annual Report – this Annual Report and Form 20-F Information 2023. API – active pharmaceutical ingredient. Articles – the Articles of Association of the Company. Astra – Astra AB, being the company with whom the Company merged in 1999. AstraZeneca – the Company and its subsidiaries. ATTR – Transthyretin amyloidosis. ATTR-CM – Transthyretin-mediated amyloid cardiomyopathy. biologic(s) or biologic medicine(s) – a class of drugs that are produced in living cells. BMS – Bristol-Myers Squibb Company. Board – the Board of Directors of the Company. BRCA – BReast CAncer gene. BRCAm – BRCA-mutated. Bureau Veritas – Bureau Veritas UK Limited. Capex – Capital expenditure. CAR-T – therapeutic chimeric antigen receptor. CDP (formerly the Carbon Disclosure Project) – a not-for-profit organisation that runs the global disclosure system for investors, companies, cities, states and regions to manage their environmental impacts. CEO – the Chief Executive Officer of the Company. CER – constant exchange rates. CFO – the Chief Financial Officer of the Company. Cheplapharm – Cheplapharm Arzneimittel GmbH. CinCor – CinCor Pharma, Inc. CKD – chronic kidney disease. Claudin 18.2 – a positive therapeutic target in gastric cancer. CLL – chronic lymphocytic leukaemia. Code of Ethics – the Group’s Code of Ethics, see page 49. Company or Parent Company – AstraZeneca PLC (formerly Zeneca Group PLC (Zeneca)). COPD – chronic obstructive pulmonary disease. COVID-19 – the official WHO name for the disease caused by the 2019 novel coronavirus. CRT – chemoradiotherapy. CTLA-4 – cytotoxic T-lymphocyte-associated antigen-4. CV – cardiovascular. CVRM – Cardiovascular, Renal & Metabolism. Daiichi Sankyo – Daiichi Sankyo, Inc. or a company within the Daiichi Sankyo group of companies. Dato-DXd – datopotamab deruxtecan. Director – a director of the Company. DTR – UK Disclosure Guidance and Transparency Rules. EBITDA – Reported Profit before tax plus net finance expense, share of after tax losses of joint ventures and associates and charges for depreciation, amortisation and impairment. EFPIA – European Federation of Pharmaceutical Industries and Associations. EGFR – epidermal growth factor receptor. EGFRm – EGFR-mutated. EPS – earnings per share: profit for the year after tax and non-controlling interests, divided by the weighted average number of Ordinary Shares in issue during the year. ESG – environmental, social and governance. ESMO – European Society for Medical Oncology. EVP – Executive Vice-President. EU – the European Union. F-gas – fluorinated greenhouse gases include: hydrofluorocarbons (HFCs), perfluorocarbons (PFCs) and sulphur hexafluoride (SF6). FDA – the US Food and Drug Administration, which is part of the US Department of Health and Human Services Agency, which is the regulatory authority for all pharmaceuticals (including biologics and vaccines) and medical devices in the US. FRC – the UK Financial Reporting Council. FX – foreign exchange. GAAP – Generally Accepted Accounting Principles. gBRCAm – germline BRCA1/2 mutations. GHG – greenhouse gas. GIA – the Group’s Internal Audit function. Gracell – Gracell Biotechnologies Inc. Gross margin – the margin, as a percentage, by which sales exceed the cost of sales, calculated by dividing the difference between the two by the sales figure. Group – AstraZeneca PLC and its subsidiaries. GSK – GlaxoSmithKline plc. GWP – Global Warming Potential. AstraZeneca Annual Report & Form 20-F Information 2023 233 Strategic Report Corporate Governance Financial Statements Additional Information Glossary |
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HCPs – healthcare professionals. HER2 – human epidermal growth factor receptor 2. HF – heart failure. HK – hyperkalaemia. HRR – homologous recombination repair. IAS – International Accounting Standards. IASB – International Accounting Standards Board. Icosavax – Icosavax, Inc. IFN – interferons. IFRS – International Financial Reporting Standards or International Financial Reporting Standard, as the context requires. Innate Pharma – Innate Pharma S.A. IP – intellectual property. IQVIA – IQVIA Solutions HQ Limited. IS – information services. ISAs – International Standards on Auditing. IT – information technology. KPI – key performance indicator. krona or SEK – references to the currency of Sweden. LABA – long-acting beta2-agonist. LAMA – long-acting muscarinic antagonist. LCA – Life-Cycle Assessment. LCM projects – significant life-cycle management projects (as determined by potential revenue generation), or line extensions. mAb – monoclonal antibody, a biologic that is specific, meaning it binds to and modulates one particular antigen. major market – US, Europe, Japan and China. MASH – metabolic dysfunction-associated steatohepatitis, previously NASH. MAT – moving annual total. mCRPC – metastatic castration-resistant prostate cancer. MedImmune – MedImmune, LLC (formerly MedImmune, Inc.). MET – tyrosine kinase receptor. MI – myocardial infarction. Moderna – Moderna Therapeutics, Inc. MSD – Merck & Co., Inc., which is known as Merck in the US and Canada, and MSD in other territories. n/m – not meaningful. Nasdaq – Nasdaq Global Select Market. Nasdaq Stockholm – previously the Stockholm Stock Exchange. Neogene – Neogene Therapeutics Inc. NME – new molecular entity. NMOSD – neuromyelitis optica spectrum disorder. NSCLC – non-small cell lung cancer. OECD – the Organisation for Economic Co-operation and Development. operating profit – sales, less cost of sales, less operating costs, plus operating income. Opex – Operating expenditure. oPCSK9 – oral proprotein convertase subtilisin/kexin type 9. Ordinary Share – an ordinary share of $0.25 each in the share capital of the Company. Orphan Drug – a drug that has been approved for use in a relatively low-incidence indication (an orphan indication) and has been rewarded with a period of market exclusivity; the period of exclusivity and the available orphan indications vary between markets. Paediatric Exclusivity – in the US, a six-month period of exclusivity to market a drug which is awarded by the FDA in return for certain paediatric clinical studies using that drug. This six-month period runs from the date of relevant patent expiry. Analogous provisions are available in certain other territories (such as European Supplementary Protection Certificate paediatric extensions). PARP – an oral poly (ADP-ribose) polymerase. PD-1 – programmed cell death protein 1. PD-L1 – an anti-programmed death-ligand 1. PFAS – per- and polyfluoroalkyl substances. Pfizer – Pfizer, Inc. PFS – progression-free survival. The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease without it getting worse. Phase I – the phase of clinical research where a new drug or treatment is tested in small groups of people (20 to 80) to check that the drug can achieve appropriate concentrations in the body, determine a safe dosage range and identify side effects. This phase includes healthy volunteer studies. Phase II – the phase of clinical research which includes the controlled clinical activities conducted to evaluate the effectiveness of the drug in patients with the disease under study and to begin to determine the safety profile of the drug. Phase II studies are typically conducted in small- or medium-sized groups of patients and can be divided into Phase IIa studies, which tend to be designed to assess dosing requirements, and Phase IIb studies, which tend to assess safety and efficacy. Phase III – the phase of clinical research which is performed to gather additional information about effectiveness and safety of the drug, often in a comparative setting, to evaluate the overall benefit/risk profile of the drug. Phase III studies usually include between several hundred and several thousand patients. PIK3CA – phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha. pMDI – pressurised metered-dose inhaler. pound sterling, £, GBP or pence – references to the currency of the UK. primary care – general healthcare provided by physicians who ordinarily have first contact with patients and who may have continuing care for them. PROTACs – a proteolysis targeting chimera, which is a heterobifunctional small molecule composed of two active domains and a linker capable of removing specific unwanted proteins. 234 AstraZeneca Annual Report & Form 20-F Information 2023 Additional Information Glossary continued |
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PTE – Patent Term Extension, an extension of up to five years in the term of a US patent relating to a drug which compensates for delays in marketing resulting from the need to obtain FDA approval. The analogous right in the EU is a Supplementary Protection Certificate. PTEN – phosphatase and tensin homolog. Pulse survey – an AstraZeneca employee opinion survey, which seeks employees’ views of the business. PwC – PricewaterhouseCoopers LLP. Quell – Quell Therapeutics, Inc. R&D – research and development. R&I – Respiratory & Immunology. rare disease – the EU defines a disease or condition as rare if it affects fewer than 1 in 2,000 people within the general population and in the US, the Orphan Drug Act defines a rare disease as a disease or condition that affects less than 200,000 people in the US. Redeemable Preference Share – a redeemable preference share of £1 each in the share capital of the Company. RCPs – Representative Concentration Pathways. RNA – ribonucleic acid. Roche – F. Hoffmann-La Roche AG. RoW – rest of world. RSV – respiratory syncytial virus. Sanofi – Sanofi S.A./Sanofi Pasteur, Inc. Sarbanes-Oxley Act – the US Sarbanes-Oxley Act of 2002. SBTs – science-based targets. sBLA – supplemental Biologics License Application. Scope 1 – Combustion of fuel and operation of facilities. Scope 2 – (Market-based): Electricity (net of market instruments), heat, steam and cooling purchased for own use. Scope 3 – (Location-based): Electricity, heat, steam and cooling purchased for own use. SEC – the US Securities and Exchange Commission, the governmental agency that regulates the US securities industry and stock markets. SEK – Swedish krona (or kronor). SET – the Senior Executive Team. SG&A – selling, general and administrative expenses. SLE – Systemic lupus erythematosus. siRNA – small interfering RNA. Sobi – Swedish Orphan Biovitrum AB. SGLT2 – sodium-glucose cotransporter 2. SPC – supplementary protection certificate. specialty care – specific healthcare provided by medical specialists who do not generally have first contact with patients. Spirogen – Spirogen Sàrl. SoC – standard of care. Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. SVP – Senior Vice-President. T2D – type 2 diabetes. TCFD – Task Force on Climate-related Financial Disclosures. TCR-T – T-cell receptor therapies. Total Revenue – the sum of Product Sales, Collaboration Revenue and Alliance Revenue. Treg – T-regulator. TROP2 – trophoblast cell-surface antigen 2. TSLP – thymic stromal lymphopoietin. TSR – total shareholder return, being the total return on a share over a period of time, including dividends reinvested. uHCC – unresectable hepatocellular carcinoma. UK – United Kingdom of Great Britain and Northern Ireland. UK Corporate Governance Code – the UK Corporate Governance Code published by the FRC in July 2018, as amended, that sets out standards of good practice in corporate governance for the UK. US – United States of America. US dollar, US$, USD or $ – references to the currency of the US. V&I – Vaccines & Immune Therapies. VBP – value-based procurement. Viela Bio – Viela Bio, Inc. WHO – World Health Organization, the United Nations’ specialised agency for health. YTE – A technology that introduces the so-called YTE (amino acid) mutation into the antibody, which prolongs the antibody’s half-life. AstraZeneca Annual Report & Form 20-F Information 2023 235 Strategic Report Corporate Governance Financial Statements Additional Information Glossary |
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Cautionary statement regarding forward‑looking statements The purpose of this Annual Report is to provide information to the members of the Company. The Company and its Directors, employees, agents and advisers do not accept or assume responsibility to any other person to whom this Annual Report is shown or into whose hands it may come and any such responsibility or liability is expressly disclaimed. In order, among other things, to utilise the ‘safe harbour’ provisions of the US Private Securities Litigation Reform Act of 1995 and the UK Companies Act 2006, we are providing the following cautionary statement: This Annual Report contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected revenues, margins, earnings per share or other financial or other measures. Forward-looking statements are statements relating to the future which are based on information available at the time such statements are made, including information relating to risks and uncertainties. Although we believe that the forward-looking statements in this Annual Report are based on reasonable assumptions, the matters discussed in the forward-looking statements may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of the preparation of this Annual Report and the Company undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by using the words ‘anticipates’, ‘believes’, ‘expects’, ‘intends’ and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things: > the ability of the Group and Icosavax to complete the transactions contemplated by the merger agreement with Icosavax, including the parties’ ability to satisfy the conditions to the consummation of the tender offer contemplated thereby and the other conditions set forth in the merger agreement with Icosavax > the ability of the Group and Gracell to complete the transactions contemplated by the merger agreement with Gracell, including the parties’ ability to satisfy the conditions set forth in the merger agreement with Gracell > the Group’s statements about the expected timetable for completing the acquisitions of Icosavax and Gracell > The Group’s and Icosavax’s beliefs and expectations and statements about the benefits sought to be achieved in the Group’s pending acquisition of Icosavax > the Group’s and Gracell’s beliefs and expectations and statements about the benefits sought to be achieved in the Group’s proposed acquisition of Gracell > the potential effects of the acquisition of Icosavax on both the Group and Icosavax and of the acquisition of Gracell on both the Group and Gracell > the possibility of any termination of the merger agreement with Icosavax or of the merger agreement with Gracell > the expected benefits and success of IVX-A12 and any combination product or GC012F and any combination product > the possibility that any milestone related to any contingent value right will not be achieved the risk of failure or delay in delivery of pipeline or launch of new medicines > the risk of failure to meet regulatory or ethical requirements for medicine development or approval > the risk of failures or delays in the quality or execution of the Group’s commercial strategies > the risk of pricing, affordability, access and competitive pressures > the risk of failure to maintain supply of compliant, quality medicines > the risk of illegal trade in our Group’s medicines > the impact of reliance on third-party goods and services > the risk of failure in IT or cybersecurity > the risk of failure of critical processes > the risk of failure to collect and manage data in line with legal and regulatory requirements and strategic objectives > the risk of failure to attract, develop, engage and retain a diverse, talented and capable workforce > the risk of failure to meet regulatory or ethical expectations on environmental impact, including climate change > the risk of the safety and efficacy of marketed medicines being questioned > the risk of adverse outcome of litigation and/or governmental investigations > intellectual property-related risks to the Group’s products > the risk of failure to achieve strategic plans or meet targets or expectations > the risk of failure in financial control or the occurrence of fraud > the impact that global and/or geopolitical events may have or continue to have on these risks, on the Group’s ability to continue to mitigate these risks, and on the Group’s operations, financial results or financial condition > the risk of failure in financial control or the occurrence of fraud > the risk of unexpected deterioration in the Group’s financial position. Certain of these factors are discussed in more detail, without limitation, in the Risk Supplement available on our website, www.astrazeneca.com/annualreport2023, and reproduced in AstraZeneca’s Form 20-F filing for 2023, available on the SEC website www.sec.gov. Nothing in this Annual Report should be construed as a profit forecast. Inclusion of Reported performance, Core financial measures and constant exchange rate growth rates AstraZeneca’s determination of non-GAAP measures, together with our presentation of them within our financial information, may differ from similarly titled non-GAAP measures of other companies. Statements of competitive position, growth rates and sales In this Annual Report, except as otherwise stated, market information regarding the position of our business or products relative to its or their competition is based upon published statistical sales data for the 12 months ended 30 September 2023 obtained from IQVIA, a leading supplier of statistical data to the pharmaceutical industry. Unless otherwise noted, for the US, dispensed new or total prescription data and audited sales data are taken, respectively, from IQVIA National Prescription Audit and IQVIA National Sales Perspectives for the 12 months ended 31 December 2023; such data are not adjusted for Medicaid and similar rebates. Except as otherwise stated, these market share and industry data from IQVIA have been derived by comparing our sales revenue with competitors’ and total market sales revenues for that period, and except as otherwise stated, growth rates are given at CER. For the purposes of this Annual Report, unless otherwise stated, references to the world pharmaceutical market or similar phrases are to the 55 countries contained in the IQVIA database, which amounted to approximately 94% (in value) of the countries audited by IQVIA. Changes in data subscriptions, exchange rates and subscription coverage, as well as restated IQVIA data, have led to the restatement of total market values for prior years. AstraZeneca websites Information on or accessible through our websites, including www.astrazeneca.com, and www.astrazenecaclinicaltrials.com and on any websites referenced in this Annual Report, does not form part of and is not incorporated into this Annual Report. External/third-party websites Information on or accessible through any third-party or external website does not form part of and is not incorporated into this Annual Report. Figures Figures in parentheses in tables and in the Financial Statements are used to represent negative numbers. Supplements For detailed information on our Development Pipeline, Patent Expiries of Key Marketed Products, Risk, and Task Force on Climate-related Financial Disclosures (TCFD) Statement, see our website, www.astrazeneca.com/annualreport2023. 236 AstraZeneca Annual Report & Form 20-F Information 2023 Additional Information Important information for readers of this Annual Report |
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Design and production Design Bridge and Partners, London. www.designbridge.com Board photography Marcus Lyon Igor Emmerich Alex Telfer SET photography Scott Nibauer Graham Carlow Philip Mynott Ossi Piispanen Vanguard site photography Todd Balfour This Annual Report is printed on Revive Silk 100 paper, manufactured from FSC® Recycled certified fibre derived from 100% pre- and post-consumer waste and Carbon Balanced with the World Land Trust. Printed in the UK by Pureprint using its pureprint® environmental printing technology, and vegetable inks were used throughout. Pureprint is a CarbonNeutral® company. Both the manufacturing mill and the printer are registered to the Environmental Management System ISO14001 and are FSC® chain-of-custody certified. |
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Registered office and corporate headquarters AstraZeneca PLC 1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA UK Tel: +44 (0)20 3749 5000 This Annual Report is also available on our website, www.astrazeneca.com/annualreport2023 |
Exhibit 15.2
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form F-3 (No. 333-256406), and Form S-8 (No. 333-240298; No. 333-226830; No. 333-216901; No. 333-170381; No. 333-152767; No. 333-124689; and No. 333-09062) of AstraZeneca PLC of our report dated 8 February 2024 relating to the financial statements and the effectiveness of internal control over financial reporting, which appears in this Form 20-F.
/s/ PricewaterhouseCoopers LLP
London, United Kingdom
20 February 2024
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PricewaterhouseCoopers LLP, 1 Embankment Place, London WC2N 6RH | ||
T: +44 (0) 2075 835 000, F: +44 (0) 2072 124 652, www.pwc.co.uk | ||
PricewaterhouseCoopers LLP is a limited liability partnership registered in England with registered number OC303525. The registered office of PricewaterhouseCoopers LLP is 1 Embankment Place, London WC2N 6RH.PricewaterhouseCoopers LLP is authorised and regulated by the Financial Conduct Authority for designated investment business and by the Solicitors Regulation Authority for regulated legal activities.
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EUROPE-LEGAL-286374644/1 106322-0213 83 Wooster Heights Road Danbury, Connecticut 06810 iqvia.com AstraZeneca PLC Legal & Secretary’s Department 1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA Dear Ladies and Gentlemen: IQVIA DATA DISCLOSURE FOR ANNUAL REPORT AND FORM 20-F INFORMATION 2023 In connection with the anticipated filing by AstraZeneca PLC (“AstraZeneca”) of a Form 20-F with the U.S. Securities and Exchange Commission, IQVIA Inc. (“IQVIA”) hereby authorizes AstraZeneca to refer to IQVIA and certain pharmaceutical industry data derived by IQVIA, as identified (highlighted in yellow) on the pages annexed hereto as Annex A, which are a selection of pages from AstraZeneca’s Annual Report and Form 20-F Information for the fiscal year ended December 31, 2023 (the “Annual Report”), each of which is incorporated by reference in the registration statement No. 333-253315 on Form F-4 for AstraZeneca, in the registration statement No. 333-256406 for AstraZeneca on Form F-3, and in the registration statements No. 333-240298, No. 333-226830, 333-21 6901, No. 333-170381, No. 333-1 52767, No. 333-1 24689 and No. 333-09062 on Form S-8 for AstraZeneca. IQVIA’s authorization is subject to AstraZeneca’s acknowledgement and agreement that: 1) IQVIA has not undertaken an independent review of the information disclosed in the Annual Report or the Form 20-F other than to discuss its observations as to the accuracy of the information relating to IQVIA and certain pharmaceutical industry data derived by IQVIA; 2) AstraZeneca acknowledges and agrees that IQVIA shall not be deemed an “Expert” in respect of AstraZeneca’s securities filings, and AstraZeneca agrees that it shall not characterize IQVIA as such; and 3) AstraZeneca accepts full responsibility for the disclosure of all information and data, including that relating to IQVIA, set forth in the Annual Report and Form 20-F as filed with the SEC and agrees to indemnify IQVIA from any third party claims that may arise therefrom. Please indicate your agreement to the foregoing by signing in the space indicated below. Our authorization will not become effective until accepted and agreed by AstraZeneca. |
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EUROPE-LEGAL-286374644/1 106322-0213 Very truly yours, /s/ Matthew R. Gilmartin Name: Matthew R. Gilmartin Title: SVP, Deputy General Counsel ACCEPTED AND AGREED This 20 day of February 2024 AstraZeneca PLC /s/ Adrian Kemp Name: Adrian Kemp Title: Company Secretary |
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EUROPE-LEGAL-286374644/1 106322-0213 Annex A (See attached) |
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2023 2022 2021 1,216 1,121 1,332 World ($bn) $1,332bn (9.6%) 2023 2022 2021 102 97 108 Established RoW ($bn) $108bn (+5.7%) 2023 2022 2021 608 556 678 US ($bn) $678bn (+11.5%) 2023 2022 2021 277 257 299 Emerging Markets ($bn) $299bn (+8.0%) 2023 2022 2021 230 211 248 Europe ($bn) $248bn (+7.8%) The external environment presents us with both challenges and opportunities that require us to adapt, innovate and build trust. Global pharmaceutical sales In 2023, average revenue grew 10.0% in Established Markets and 8.0% in Emerging Markets. The US, Japan, China, Germany and France are the world’s top five pharmaceutical markets by 2022 sales. In 2023, the US had 50.9% (2022: 50.0%) of global sales. Data based on world market sales using AstraZeneca Market definitions as set out on page 232. Changes in data subscriptions, exchange rates and subscription coverage, as well as restated IQVIA data, have led to the restatement of total market values for prior years. Source: IQVIA, IQVIA Midas Quantum Q2 2023 (including US data). Reported values and growth are based on CER. Value figures are rounded to the nearest billion and growth percentages are rounded to the nearest tenth. We expect both developed and developing markets to fuel pharmaceutical growth. Market growth in China is expected to remain below historical levels at a compound annual growth rate of 3.9%, due to the continued slowdown of the major hospital sector. 1 Non-EU countries; including the UK. 2 Commonwealth of Independent States; includes Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and excludes Ukraine. $1,332bn (+9.6%) Estimated pharmaceutical sales 2027. Data is based on ex-manufacturer prices at CER. Source: IQVIA. Estimated pharmaceutical market growth. Data is based on the compound annual growth rate from 2022 to 2027. Source: IQVIA Market Prognosis Global 2023–2027. Other Europe1 $93bn 10.6% Japan $73bn 0.3% China $190bn 3.9% Oceania $21bn 3.9% Southeast and East Asia $270bn 4.8% Middle East $32bn 6.6% Africa $32bn 5.9% Indian subcontinent $51bn 9.5% CIS2 $37bn 6.3% EU $335bn 6.2% North America $992bn 7.8% Latin America $197bn 22.0% Estimated pharmaceutical sales and market growth to 2027 A growing pharmaceutical sector The pharmaceutical sector continues to grow against a backdrop of increasing demand for healthcare. Global pharmaceutical sales grew by 9.6% in 2023. Global healthcare spending is projected to increase at an annual rate of 7.8% from 2022 to 2027. Healthcare in a Changing World Healthcare in a Changing World AstraZeneca Annual Report & Form 20-F Information 2023 7 Strategic Report Corporate Governance Financial Statements Additional Information |
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Unmet medical need and world market 2nd Cancer is the second leading cause of death worldwide. 16.3m By 2040, cancer is expected to account for 16.3 million deaths annually across the globe. Small molecule targeted agents $56.2bn Immune checkpoint inhibitors $45.1bn Monoclonal antibodies (mAbs) $40.0bn Chemotherapy $23.3bn Hormonal therapies $17.7bn PARP inhibitors $3.5bn Other oncology therapies $1.0bn $187.0bn Annual worldwide market value Therapy area world market (MAT Q3-23) We are leading a revolution in oncology to redefine cancer care. Our ambition is to follow the science to discover, develop and deliver life-changing treatments that transform outcomes and increase the potential for cures. Oncology 2023 overview > Performance driven by rapid and broad market penetration of our oncology medicines with 10 major market approvals across six medicines, including Imfinzi, Enhertu, Lynparza, Calquence, Imjudo and a new medicine approved for the first time, Truqap. > Nine positive Phase III trial readouts across tumour types including the first positive pivotal results for datopotamab deruxtecan (Dato-DXd) in lung and breast cancers. Total Revenue $18,447m up 19% (21% at CER) 2022: $15,539m 2021: $13,555m1 Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Oncology Therapy Area submarket totals ($186.8bn) do not sum up exactly to the Therapy Area total ($187.0bn) due to rounding. 1 Total Revenue from Koselugo is included within Rare Disease for 2022 and 2023 reporting, previously reported within Oncology. The 2021 comparatives and growth rates shown for each therapy area have been calculated as though these changes had been implemented in 2021. T-cell engager molecule directing a T-cell to a cancer cell 16 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Therapy Area Review |
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Unmet medical need and world market 20 million deaths per year due to CVRM diseases. 4 of the 10 top causes of death globally are due to CVRM diseases. Unmet medical need and world market >40 million people worldwide have the immune-mediated diseases we are targeting, which carry a high disease burden. 3rd Chronic obstructive pulmonary disease (COPD) is the world’s third leading cause of death. Unmet medical need and world market Up to 4% of the population is immunocompromised and is at a higher risk of hospitalisation from COVID-19 than the general population. One billion cases of seasonal influenza annually. 1 Total Revenue from Andexxa is included within BioPharmaceuticals: CVRM for 2023 and 2022 reporting, previously reported within Rare Disease. The 2021 comparatives and growth rates shown for each therapy area have been calculated as though these changes had been implemented in 2021. 2023 overview > Forxiga, the number one SGLT2 inhibitor worldwide by volume, expanded its label from type 2 diabetes (T2D) and chronic kidney disease (CKD) to address cardiovascular (CV) death and hospitalisation for a broader range of heart failure (HF) populations. > Acquisition of CinCor and exclusive licence agreement with Eccogene bolstered the cardiorenal pipeline in hypertension, obesity, T2D and other cardiometabolic conditions. > Eplontersen demonstrated sustained benefit in Phase III trial for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) through 85 weeks. 2023 overview > Continued strong portfolio growth despite Symbicort patent expiry in the US, significant portfolio transformation, where key launch brands (Breztri, Fasenra, Tezspire, Saphnelo) represented circa 50% of the total portfolio at the year end. > Fasenra met the primary endpoint in the MANDARA Phase III trial demonstrating non-inferior rates of remission compared to mepolizumab in eosinophilic granulomatosis with polyangiitis (EGPA) patients. > Collaboration with Quell Therapeutics and proposed acquisition of Gracell Biotechnologies to boost the Immunology portfolio. 2023 overview > Beyfortus approved in the US and in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in infants and RSV lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season, respectively. > Supplemental Biologics Licence Application (sBLA) for the approval of a self- or caregiver-administered option for FluMist Quadrivalent accepted for review by the FDA. > Proposed acquisition of Icosavax bolsters the pipeline with investigational RSV and human metapneumovirus (hMPV) combination vaccine. > Emergency Use Authorisation in the US requested for the investigational long-acting antibody sipavibart for pre-exposure prophlylaxis of COVID-19. Our ambition is to improve care to save lives for the millions living with cardiovascular, renal and metabolic (CVRM) diseases, stop disease progression and, ultimately, pave the way to a cure. Total Revenue $10,628m up 15% (18% at CER) 2022: $9,211m 2021: $8,103m1 Cardiovascular, Renal & Metabolism Total Revenue $6,404m up 7% (10% at CER) 2022: $5,963m 2021: $6,049m Respiratory & Immunology Total Revenue $1,357m down 72% (71% at CER) 2022: $4,836m 2021: $4,779m Our ambition is to transform respiratory and immunology care for patients, moving beyond symptom control to disease modification, remission and, one day, cure. Our ambition is to develop and deliver transformative vaccines and antibodies, providing long-lasting immunity to millions, and supporting sustainable and resilient healthcare systems worldwide by reducing the burden of frequent infectious diseases. Vaccines & Immune Therapies AstraZeneca Annual Report & Form 20-F Information 2023 21 Strategic Report Corporate Governance Financial Statements Additional Information Therapy Area Review / BioPharmaceuticals |
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Diabetes $159.3bn High blood pressure $37.1bn Abnormal levels of blood cholesterol $19.2bn CKD $9.4bn Thrombosis $6.9bn CKD-associated anaemia $5.3bn Hyperkalaemia $0.9bn Other CV $58.0bn $286.1bn Annual worldwide market value Therapy area world market (MAT Q3-23) Key marketed products Product Disease Total Revenue Commentary Farxiga/Forxiga (dapagliflozin) T2D HF CKD $5,997m, up 37% (39% at CER) Forxiga is the number one prescribed SGLT2i worldwide by volume. In August, Forxiga received a 1st-line recommendation from the 2023 European Society of Cardiology Treatment Guidelines for HF across the range of ejection fractions. Brilinta/Brilique (ticagrelor) Acute coronary syndromes (ACS) $1,324m, down 2% (1% at CER) Brilinta plus aspirin is currently approved in more than 115 countries for the prevention of atherothrombotic events in adult patients with ACS and in 80 countries for the secondary prevention of CV events among high-risk patients who have experienced a heart attack. Lokelma (sodium zirconium cyclosilicate) Hyperkalaemia (HK) $412m, up 43% (46% at CER) Lokelma is now approved in 56 markets and is market leader by value and days-of-therapy volume in branded HK. Roxadustat Anaemia of CKD $276m, up 37% (44% at CER) Andexxa/Ondexxya (andexanet alfa) Factor Xa (FXa) inhibitor reversal agent $182m, up 14% (15% at CER) In June 2023, the Andexxa Phase IV (Annexa-I) trial stopped early after achieving pre-specified criteria on haemostatic efficacy versus usual care. Other products Crestor (rosuvastatin calcium) Dyslipidaemia Hyper-cholesterolaemia $1,110m, up 6% (12% at CER) Seloken/Toprol-XL (metoprolol succinate) Hypertension HF Angina $641m, down 26% (20% at CER) Onglyza family, (exenatide, Qtern, Symlin, Atacand and other established brands) n/a $227m, down 12% (8% at CER) Bydureon (exenatide XR injectable suspension) T2D $163m, down 42% (42% at CER) Wainua (eplontersen) polyneuropathy of hereditary transthyretin-mediated amyloidosis n/a On 21 December in the USA, Wainua (eplontersen) was granted its first-ever regulatory approval for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis. Cardiovascular, Renal & Metabolism Our strategy in CVRM Our ambition is to improve and save lives for the millions of people who are living with the complexities of CVRM diseases. > The impact of CVRM diseases on people, society and our planet is immense and growing, yet these diseases remain underdiagnosed, undertreated, and their interconnections under-recognised. > By understanding their interconnections and targeting the mechanisms that drive CVRM diseases, we will be able to detect, diagnose and treat people earlier and more effectively, stop disease progression and ultimately pave the way to a cure. > AstraZeneca is uniquely positioned to improve the outcomes of patients living with CVRM diseases today and tomorrow with our strong and expanding portfolio and a broad, deep and innovative pipeline delivered by a talented, passionate and diverse team. > We are building the leading CVRM business. 2023 review – strategy in action Our CVRM strategy is focused on four key areas: CV, renal, HF, and metabolic diseases. Cardiovascular (CV) CV disease is the leading cause of death and is responsible for approximately one third of all deaths globally. Our ambition is to reduce CV risk by improving hypertension control and reducing dyslipidaemia. > We continue to make a difference for patients with Brilinta, now approved in more than 124 countries for atherosclerosis and in 82 countries for high-risk patients with history of heart attack. > Andexxa is designed to bind to FXa inhibitors and rapidly reverse their anticoagulant effect in patients with major bleeds. In June, the Andexxa Phase IV (Annexa-I) trial stopped early after achieving pre-specified efficacy criteria versus usual care. The results of the trial have been presented at the World Stroke Congress and submitted for publication. > In February 2023, AstraZeneca completed the acquisition of CinCor, focused on developing baxdrostat, an investigational once-daily medication, for the treatment of hard-to-treat hypertension. > There is also a need for new approaches to stop progression of atherosclerosis caused by dyslipidaemia. AZD0780 is an oral inhibitor (oPCSK9) being developed for greater ease of use and enhanced convenience, aiming to drive reduction in LDL-C levels not achievable by statins alone. Renal Nearly 850 million people worldwide, or more than one in 10 people, are affected by kidney disease and more than 90% of people with CKD remain undiagnosed. Our ambition in CKD is to eliminate progression to kidney failure. > Forxiga is now approved in over 120 markets for the treatment of CKD. > In November, results from the real-world ZORA observational multicountry study showed that treating HK with the potassium Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Sales for CKD ($9.4bn) and CKD-associated anaemia ($5.3bn) fall outside the CVRM total market. All sales for CKD-associated anaemia ($5.3bn) fall within the CKD market and should not be double counted. Full details are given in the Development Pipeline and Patent Expiries of Key Marketed Products Supplements on our website, www.astrazeneca.com/ annualreport2023. Therapy Area Review BioPharmaceuticals continued 22 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Asthma $25.0bn COPD $17.4bn Other $46.3bn $88.8bn Annual worldwide market value Therapy area world market (MAT Q3-23) Key marketed products Product Disease Total Revenue Commentary Symbicort (budesonide/ formoterol) Asthma COPD $2,362m, down 7% (4% at CER) Retained global market leadership. Only ICS/LABA approved as an anti-inflammatory reliever in 47 countries, with regulatory reviews anticipated in additional countries. Fasenra (benralizumab) Severe eosinophilic asthma $1,553m, up 11% (12% at CER) Currently approved as an add-on maintenance treatment for severe eosinophilic asthma in 80 countries including the US, EU and Japan. Breztri/Trixeo (budesonide/ glycopyrrolate/ formoterol) COPD $677m, up 70% (73% at CER) The fastest-growing global triple therapy1; approved in more than 73 countries, including the US, EU, Japan and China. More prominent role of fixed-dose triple therapies for early treatment, including mortality reduction benefits, reflected in 2023 GOLD report. Tezspire (tezepelumab) Severe asthma $345m, up 318% (319% at CER) Approved in more than 45 countries including the US, EU and Japan for the treatment of severe asthma without biomarker or phenotypic limitations. Regulatory reviews are ongoing in additional countries. Saphnelo (anifrolumab) Systemic lupus erythematosus (SLE) $280m, up 140% (141% at CER) Approved in 61 countries, including the US, EU and Japan. Included in 2023 European Alliance of Associations for Rheumatology (EULAR) recommendations for the management of SLE. Other products Pulmicort (budesonide) Asthma COPD Croup $713m, up 11% (17% at CER) Approved in more than 115 countries. Bevespi (glycopyrrolate/ formoterol) COPD $58m, stable at 0% (stable at 0% at CER) Approved in 46 countries, including the US, EU, Japan and China. Daliresp/Daxas (roflumilast) COPD $54m, down 72% (72% at CER) Approved in more than 50 countries, including the US and EU. 1 Global triple therapy market definition: Breztri, Enerzair, Trelegy, Trimbow. Respiratory & Immunology Our strategy in Respiratory & Immunology Our ambition is to transform care in respiratory and immune-mediated diseases by moving beyond symptom control to achieve disease modification, remission and, one day, cures for millions of patients worldwide. COPD We are working to eliminate COPD as a leading cause of death by transforming care through our broad portfolio. Our strategy is to: > Drive earlier diagnosis and prompt intervention with the most effective therapies to reduce mortality by preventing exacerbations and reducing cardiopulmonary risk. > Advance innovative biology and novel therapeutic platforms including next-generation biologics and orals that will enable us to slow disease progression, drive disease modification, and reverse the structural damage caused by the disease. Asthma Our ambition in asthma is to eliminate asthma attacks and achieve clinical remission, even in people with the most severe asthma. Our strategy is to: > Establish our anti-inflammatory reliever inhaled portfolio as the backbone of care. > Drive towards clinical remission with systemic biologics, and with pre-biologics for those patients not controlled on current therapies. > Introduce new modality therapies and bring forward precision medicine opportunities. Immunology Our ambition is to disrupt immunology by focusing on areas of high unmet medical need to drive clinical remission and eventually cure. Our strategy is to: > Lead in lupus. > Disrupt in established diseases with suboptimal treatment outcomes through precision medicine and novel mechanisms with a combination of our mid-stage internal pipeline and external collaborations, targeting diseases such as inflammatory bowel disease (IBD) and rheumatoid arthritis. > Invest in future transformative technologies with curative potential, such as complex biologics and cell therapy. New Respiratory We are also moving beyond asthma and COPD to address other respiratory diseases with significant unmet medical need, including severe viral lung infection, interstitial lung disease and idiopathic pulmonary fibrosis (IPF). 2023 review – strategy in action COPD Breztri, our triple inhaled therapy continues to gain market share, demonstrating strong volume growth within the growing fixed-dose combination triple class across major markets. In October 2023, patients received their first dose in the ATHLOS Phase III trial exploring Breztri’s ability to improve parameters that indicate cardiopulmonary function in COPD. Breztri is also being studied in asthma in two Phase III pivotal trials, KALOS and LOGOS. The OBERON and TITANIA Phase III trials of tozorakimab (anti-IL-33 mAb) are ongoing. In October 2023, patients received their first dose in the MIRANDA Phase III trial of tozorakimab. Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Therapy Area Review BioPharmaceuticals continued Full details are given in the Development Pipeline and Patent Expiries of Key Marketed Products Supplements on our website, www.astrazeneca.com/ annualreport2023. 24 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Compounds in early-stage clinical development include: > Mitiperstat, a selective MPO inhibitor in Phase II. A 10-fold increase in MPO (an enzyme associated with oxidative stress) concentration is associated with a 40% increase of risk of a COPD exacerbation. > AZD6793, an oral IRAK4 inhibitor that targets many of the key pathways triggered by bacterial and viral infections, smoke and other environmental factors in COPD patients. Asthma Symbicort maintained its position as the leading inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) globally by volume. Performance has been driven by strong growth in Emerging Markets, offset by generic erosion in the EU, US and Japan. In January 2024, Airsupra launched in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older, offering the first and only FDA approved anti-inflammatory rescue therapy to treat airway obstruction and inflammation concomitantly. AstraZeneca entered into a co-development agreement with Bond Avillion 2 Development in March 2018 for the development of the then drug candidate PT027 for asthma in the US. Fasenra, our first respiratory biologic has reached more than 119,000 patients with severe eosinophilic asthma. In April, we announced positive results from the MIRACLE Phase III trial, an efficacy and safety study of Fasenra in patients in Asia with a history of uncontrolled severe eosinophilic asthma. A Phase III trial in COPD, RESOLUTE, is also ongoing. Tezspire is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label. Tezspire’s strong performance continues following approval, gaining market share and achieving broad labels and reimbursement globally. Compounds in early-stage clinical development for asthma include: > AZD8630, an inhaled fragment antibody (inhaled biologic) in co-development with Amgen, that targets thymic stromal lymphopoietin. > Atuliflapon (AZD5718), a precision medicine approach in asthma with an oral 5-lipoxygenase-activating protein (FLAP) inhibitor that blocks the 5-lipoxygenase pathway, a clinically validated target which could offer an alternative for uncontrolled patients before becoming eligible for systemic biologics. > AZD4604, an inhaled JAK1 inhibitor that has the potential to block the effects of T2-high pro-inflammatory pathways (IL4/13, TSLP) and T2-lower pathways (IL6, IL17), many of which are poorly responsive to ICS in patients with asthma. New Respiratory The TILIA Phase III trial of tozorakimab in severe viral lower respiratory tract disease is ongoing. Other compounds in early-stage clinical development include: > AZD0292, an anti-pseudomonas aeruginosa mAb for the treatment of bronchiectasis. Immunology Saphnelo continues to grow rapidly during its launch phase and in June 2023, was included in the 2023 EULAR recommendations for the management of SLE, less than two years after first launch. Fasenra’s life-cycle management programme includes multiple clinical trials in eosinophilic diseases beyond the current severe asthma indication. In September 2023, we announced positive high-level results from the MANDARA Phase III trial which showed that Fasenra met the primary endpoint and demonstrated non-inferior rates of remission compared to mepolizumab in patients with EGPA who were receiving oral corticosteroids with or without stable immunosuppressive therapy. MANDARA is the first head-to-head trial of biologics in EGPA, comparing a single injection of Fasenra to three injections of mepolizumab, every four weeks. Full results from the trial were presented in November 2023 at the American College of Rheumatology Convergence meeting. Compounds in early-stage clinical development include: > AZD7798, a CCR9-depleting mAb. CCR9 is the main chemokine receptor for trafficking lymphocytes to the small intestine and considered central to the generation of small bowel inflammation in Crohn’s disease. In June 2023, we announced an agreement with Quell Therapeutics to develop, manufacture and commercialise engineered T-regulator (Treg) cell therapies for autoimmune diseases in order to reset immune tolerance and drive durable responses for patients. In 2023, we also announced the proposed acquisition of Gracell Biotechnologies. In June 2023, the clinical development programme for brazikumab, an anti-IL-23 mAb, in IBD was discontinued. Decarbonising respiratory care Chronic respiratory diseases are examples of the growing health impact of climate change. Poor air quality and extreme weather pose great risks to people living with asthma and COPD, and increase the number of people developing these diseases. We are dedicated to discovering and developing respiratory medicines that improve outcomes for patients as well as lowering the carbon footprint of respiratory care which stems from the use of medicines, doctor visits and hospital care. Early detection, diagnosis and disease control to avoid exacerbations are powerful ways to reduce overall healthcare resource utilisation and hospitalisations, and thus the carbon footprint of care. In addition to efforts to improve outcomes for patients, we are also decarbonising respiratory care by transitioning to climate-friendly inhaled medicines, moving our entire portfolio to a next-generation propellant with near-zero Global Warming Potential. AstraZeneca Annual Report & Form 20-F Information 2023 25 Strategic Report Corporate Governance Financial Statements Additional Information Therapy Area Review / BioPharmaceuticals / Respiratory & Immunology |
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$12.3bn Annual worldwide market value Therapy area world market (MAT Q3-23) Key marketed products Product Disease Total Revenue Commentary COVID-19 mAbs (tixagevimab and cilgavimab) COVID-19 $312m, down 86% (85% at CER) Authorised for pre-exposure prophylaxis (prevention) of COVID-19 (emergency use) in EU, Japan and many other countries. Approved for the treatment of COVID-19 in the EU and Japan. US emergency use authorisation for Evusheld revised in January 2023 to limit its use to when the combined frequency of non-susceptible variants in the US is ≤90%. Beyfortus (nirsevimab) RSV $262m, up 961% (945% at CER) (2022: $25m) Approved in the EU, US, UK, China and Canada. In collaboration with Sanofi. Sanofi has full commercial control of Beyfortus in the US. Vaxzevria (ChAdOx1-S [Recombinant]) COVID-19 $12m, down 99% (99% at CER) (2022: $1,875m) More than three billion vaccine doses have been released for supply to over 180 countries. Other products Synagis (palivizumab) RSV $546m, down 6% (2% at CER) Available in more than 100 countries outside the US. Sobi holds the US rights. Fluenz Tetra/ FluMist Quadrivalent (live attenuated influenza vaccine) Influenza $226m, up 30% (22% at CER) Approved in the US, EU and other countries. Daiichi Sankyo holds rights to FluMist Quadrivalent in Japan. Vaccines & Immune Therapies Our strategy in Vaccines & Immune Therapies We have a portfolio of medicines that includes vaccines for COVID-19 and influenza, long-acting antibodies for COVID-19 and RSV, and a pipeline of next-generation therapeutics and scientific platforms. We are optimising the potential of both vaccines and antibodies, providing long-lasting immunity and supporting sustainable and resilient healthcare systems worldwide by reducing the burden of frequent infectious diseases. Vaccines We are engineering next-generation vaccines that have the potential to generate potent and long-lasting immune responses. Advancing our ambition in vaccines, in January 2024 we entered a collaboration agreement with US-based biotechnology company Omniose to research vaccines for serious bacterial diseases, and we will have exclusive rights to Omniose’s proprietary bioconjugation platform for up to three years. Antibodies We are pioneering novel approaches to develop highly targeted, long-acting antibodies, using our half-life extension technology. We have significantly accelerated the speed at which we are able to identify potent antibody candidates, screening billions of antibody candidates in a matter of months. This complementary approach, with vaccines providing potential protection for those able to mount their own immune response, and antibody therapies for those who cannot, aims to ensure quality care for all. 2023 review – strategy in action Our Vaccines & Immune Therapies strategy is focused on reducing the burden of respiratory infections, including RSV, hMPV, COVID-19 and influenza. Respiratory syncytial virus Beyfortus is a single dose long-acting antibody (LAAB), developed and commercialised from an alliance between AstraZeneca and Sanofi, using AstraZeneca’s proprietary YTE half-life extension technology. In April 2023, AstraZeneca, Sobi and Sanofi updated and simplified their contractual arrangements relating to the development and commercialisation of Beyfortus in the US. In July 2023, Beyfortus was approved in the US for the prevention of RSV LRTD in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. In the US, Beyfortus is the first approved and recommended immunisation to prevent severe RSV disease in all infants under eight months by the CDC Advisory Committee on Immunization Practices. In January 2024, Beyfortus was approved in China for the prevention of RSV LRTI in neonates and infants entering or during their first RSV season and is anticipated to be available during the upcoming 2024 to 2025 RSV season. Regulatory applications are currently under review in Japan and other countries. Since its initial approval in 1998, Synagis has become a global SoC for RSV prevention and helps protect at-risk babies against RSV. In February 2023, new cost-effectiveness analysis of Synagis for the prevention of RSV infection in otherwise healthy Canadian infants born at 29-35 weeks’ gestational age, was presented at the 7th Respiratory Syncytial Virus Foundation Conference in Lisbon, Portugal. Our agreement with Sobi for the rights to Synagis in the US remains ongoing. In December 2023, AstraZeneca announced an agreement to acquire Icosavax, to bolster the Vaccines & Immune Therapies pipeline with a potential first-in-class, Phase III-ready, combination vaccine against RSV and hMPV, using an innovative, protein virus-like particle platform. COVID-19 AZD3152 is an investigational next-generation LAAB being developed to potentially protect vulnerable patients such as the immunocompromised from COVID-19, given that they may not have any other non-vaccine option. In July 2023, AstraZeneca shared positive high-level results from the Phase I safety cohort of the ongoing SUPERNOVA Phase I/III COVID-19 prevention trial, which showed that AZD3152 was generally well-tolerated and displayed pharmacokinetics consistent with Evusheld through to day 29. AstraZeneca licensed AZD3152 from RQ Biotechnology in May 2022. Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Therapy Area Review BioPharmaceuticals continued Full details are given in the Development Pipeline and Patent Expiries of Key Marketed Products Supplements on our website, www.astrazeneca.com/ annualreport2023. 26 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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The dysregulation of the complement system, an essential part of the immune system, is a key driver of many devastating diseases. Targeting and inhibiting the complement system before it can trigger tissue damage or destruction can help restore balance. Therapy Area Review 2023 overview > Geographic expansion and pipeline diversification enabling continued C5 leadership and sustainability of complement franchise. > Advancing innovative therapies for non-complement mediated diseases with limited scientific progress or few therapeutic options. > Strategic collaborations to strengthen next-generation research capabilities: – Accelerating genomic medicine ambition via acquisition of Pfizer’s preclinical gene therapy portfolio; – Leveraging AI and new technologies to drive science-led innovation across drug discovery, clinical diagnostics and patient engagement. Total Revenue $7,764m up 10% (12% at CER) 2022: $7,053m 2021: $3,110m1 1 Total Revenue from Koselugo is included within Rare Disease for 2023 and 2022 reporting, previously reported within Oncology, and Total Revenue from Andexxa is included within BioPharmaceuticals: CVRM for 2023 and 2022 reporting, previously reported within Rare Disease. The comparatives and growth rates shown for each therapy area have been calculated as though these changes had been implemented in 2021. Rare Disease After more than two full years as Alexion, AstraZeneca Rare Disease, our medicines are helping patients in 70 countries. As we expand the reach of our medicines, our growing pipeline of investigational molecules represents continued innovation on behalf of rare disease patients. Our mission remains to transform the lives of people affected by rare diseases through the development and delivery of innovative medicines as well as supportive technologies and healthcare services. Unmet medical need and world market 400m people around the world are living with a rare disease. >10,000 estimated number of rare diseases; fewer than 10% have approved treatment options. For more information, see: Science and Innovation from page 34. Growth and Therapy Area Leadership from page 38. Source: IQVIA. AstraZeneca focuses on specific segments within this overall therapy area market. Therapy area world market (MAT Q3-23) $158.4bn Annual worldwide market value 28 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Sales and marketing Our growth is delivered by our Commercial teams, which employed 45,888 people at the end of 2023. During the year, we had an active presence in 85 countries and sold our products in more than 125 countries. In most markets, we sell our medicines through wholly-owned local marketing companies. We also sell through distributors and local representative offices. We market our products largely to primary and specialty care physicians. Summary and performance indicators We plan to meet our growth and profitability goals through innovation, commercial excellence and the creation of sustainable profitability. Our performance in 2023 > Total Revenue, comprising Product Sales, Alliance Revenue and Collaboration Revenue, increased by 3% (6% at CER) to $45,811 million. Total Revenue excluding COVID-19 medicines increased by 13% (15% at CER) to $45,488 million. > In the US, Total Revenue increased by 6% to $19,077 million and in Europe by 10% (8% at CER) to $9,611 million. > Total Revenue in Emerging Markets increased by 2% (9% at CER) to $12,025 million, with an increase in China of 1% (7% at CER) to $5,876 million. > Continued collaboration with payers to conclude outcomes- and value-based reimbursement models that improve patient outcomes and enable access to medicines. > Committed to high ethical standards: 296 employees and third parties were removed from their roles for breaches of sales and marketing regulations or codes. > Delivered 282 successful market launches. > Completed more than 20 major or strategically important business development transactions. Our regions We strive to meet our growth and profitability goals through commercial excellence in each of our global reporting regions. US As the tenth-largest prescription-based pharmaceutical company in the US, we have a 3.6% market share of US pharmaceuticals by sales value. Total Revenue increased by 6% in 2023 to $19,077 million, driven by the continued growth of our Oncology medicines and Farxiga. Recent launches in heart failure and chronic kidney disease drove an increase in market share. The US healthcare system is complex. Multiple payers and intermediaries influence patient access to branded medicines through regulatory rebates in government programmes and voluntary rebates paid to managed care organisations and pharmacy benefit managers for commercially insured patients. Significant pricing pressure is driven by payer consolidation, restrictive reimbursement policies and cost control tools, such as exclusionary formularies and price protection clauses. Many formularies employ ‘generic first’ strategies and/or require physicians to obtain prior approval for the use of a branded medicine where a generic alternative exists. The Inflation Reduction Act (IRA) of 2022 was passed to address affordability concerns. Farxiga has been selected in the first round of negotiations under the IRA, with the price taking effect in 2026, which is the same year we expect to lose exclusivity, and the impact is therefore expected to be manageable. We are evaluating our portfolio to understand timings associated with the potential inclusion of other medicines in future negotiations. We have a diversified product portfolio providing a broad spectrum of treatments in different therapy areas, allowing access for patients in need of our innovative medicines. Europe The total European pharmaceutical market was worth $248 billion in 2023. We are the seventh-largest prescription-based pharmaceutical company in Europe (see market definitions on page 232) with a 3.3% market share of pharmaceutical sales by value. Total Revenue was $9,611 million, up 10% (8% at CER). Growth and Therapy Area Leadership Key Performance Indicators Global Total Revenue by geography 2023 2022 2021 Total Revenue $m Actual growth % CER growth % Total Revenue $m Actual growth % CER growth % Total Revenue $m Actual growth % CER growth % US 19,077 6 6 17,920 47 47 12,228 38 38 Emerging Markets 12,025 2 9 11,745 (4) 1 12,281 41 36 Europe 9,611 10 8 8,738 9 21 8,050 45 40 Established Rest of World 5,099 (14) (8) 5,948 22 40 4,858 37 37 Total 45,811 3 6 44,351 19 25 37,417 41 38 38 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Business Review continued |
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Established Rest of World (RoW) Established RoW comprises Japan, Canada, Australia and New Zealand. In 2023, Total Revenue decreased by 14% (8% at CER) to $5,099 million, with sales in Japan down 10% (3% at CER) to $3,705 million. Emerging Markets With Total Revenue of $12,025 million, up 2% (9% at CER), AstraZeneca was the second-largest multinational pharmaceutical company, as measured by prescription sales, and the fifth fastest-growing top 10 multinational pharmaceutical company in Emerging Markets in 2023. In China, AstraZeneca is the largest pharmaceutical company in the hospital sector, as measured by sales value. In 2023, Total Revenue increased by 1% at actual rate of exchange (7% at CER) to $5,876 million (2022: $5,792 million). Roxadustat and Lokelma were renewed in the National Reimbursement Drug List (NRDL) and Xigduo, Tagrisso (ADAURA), Lynparza (PAOLA-1), Calquence, Soliris and Koselugo achieved listing for the first time. Since the implementation of VBP, several AstraZeneca brands have been impacted. In the most recent cycles of VBP implementation, Faslodex and Plendil were included. Additional AstraZeneca brands are expected to be included in future VBP cycles. There was some impact on demand in the second half of the year, mainly with oncology products, following the government anti-corruption campaign announced in July 2023. We were shocked following the Russian invasion of Ukraine in February 2022 and, since then, have provided practical support to ensure the safety, health and wellbeing of our employees. As a healthcare business, we are doing everything possible to ensure medical supply chains continue to operate and that patients in both countries are able to access our medicines, while complying with sanctions imposed on Russia. Healthcare in low- and middle-income countries BV AstraZeneca is committed to building resilient and sustainable health systems and improving equitable access to healthcare. By working collaboratively, we remove barriers to care and support the development and delivery of healthcare, particularly in low- and middle-income countries. We also adapt our programmes to suit local health systems and communities, contributing to health system capacity and resilience through training, education, prevention and early detection and diagnosis. AstraZeneca in Japan We are the second-largest prescription-based pharmaceutical manufacturer with a 6.1% value market share of Innovative Branded pharmaceutical sales by value, and have gained recognition as being a great place to work by the Great Place to Work Institute. Pricing and value of our medicines Increasing demand for healthcare means increasing pressure on health system budgets. This shift results in price and reimbursement restrictions in many markets. These pressures also result in movement from primary to speciality care, including rare diseases, which comprise a growing share of our portfolio. This pricing pressure, coupled with higher rates of inflation, means that we are unable to pass on the full impact of price increases. Pricing for our medicines seeks to reflect the value they bring to patients, payers and society, and the significant investment required for targeted treatment options. In our discussions with national, regional and local stakeholders, we base our pricing policies on four principles: sustainability, value, access and flexibility. We collaborate with payers to conclude innovative outcomes and value-based reimbursement models that improve patient outcomes and enable access to medicines across key therapeutic areas and geographic regions. We also offer a number of patient assistance programmes that help increase patients’ access to medicines and/or healthcare by reducing their cost burden. Responsible sales and marketing BV As outlined in the Code of Ethics on page 49, we are committed to high ethical standards. Our compliance professionals advise on, and monitor, adherence to our Code and policies, and work with local staff to ensure we meet our ethical standards. Nominated signatories review product promotional materials and activities to ensure compliance with applicable regulations and codes of practice, and that information is accurate and balanced. Group Internal Audit conducts audits of selected marketing companies. In 2023, we identified four confirmed external breaches across our Commercial business (2022: 10). There were 3,758 instances (instances can involve multiple people) of employee and third-party non-compliance with our policies (2022: 2,872). A total of 296 employees and third parties were removed from their role as a result of a breach (2022: 147) and 2,968 received warnings (2022: 3,326). We brief our Audit Committee quarterly on breach statistics, serious incidents and corresponding remediation. Breaches primarily consist of low-impact incidents. We continue to foster a culture where employees can speak their minds, with strong first-line oversight (and related reporting) as well as targeted second-line monitoring to identify concerns early, and use learnings to improve our programme. Anti-bribery and anti-corruption BV We do not tolerate bribery or any other form of corruption. Preventing bribery and corruption are a focus of our third-party risk management and due diligence processes, as well as our monitoring and audit programmes. We reinforce our commitment to ethical business conduct through our annual Code of Ethics training, which is delivered to all employees and relevant third parties. For more information, see Access to healthcare from page 47. For more information on our pricing policies, see our Sustainability Report on our website, www.astrazeneca.com/ sustainability. Business Review / Growth and Therapy Area Leadership AstraZeneca Annual Report & Form 20-F Information 2023 39 Strategic Report Corporate Governance Financial Statements Additional Information |
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The Senior Executive Team, or SET, is the body through which the CEO exercises the authority delegated to him by the Board. The CEO leads the SET and has executive responsibility for the management, development and performance of the business. The CEO, CFO and SET also take the lead in developing the strategy for review, constructive challenge and approval by the Board as part of the annual strategy review process. SET members who sit on the Board: > Pascal Soriot CEO > Aradhana Sarin CFO Sharon Barr Executive Vice-President, BioPharmaceuticals R&D Sharon joined in 2021 and is responsible for discovery through to late-stage development across CVRM and Respiratory & Immunology. Previously, Sharon was SVP, Head of Research and Product Development of Alexion. Sharon undertook a PhD in molecular biology from NYU and a postdoctoral fellowship at Stanford University. Ruud Dobber Executive Vice-President, BioPharmaceuticals Business Unit Ruud is responsible for the CVRM, Respiratory & Immunology, neuroscience and infection business units. Ruud joined AstraZeneca in 1997 and held various executive roles externally before this. Ruud was previously a research scientist in immunology and ageing, holding a doctorate in immunology from the University of Leiden. Jeff Pott Chief Human Resources Officer, Chief Compliance Officer and General Counsel Jeff is responsible for all aspects of AstraZeneca’s People strategy and leads our HR, Compliance, and Legal and IP functions. Jeff joined in 1995, before which he specialised in pharmaceutical product liability and antitrust litigation. He holds a Bachelor’s degree from Wheaton College and a Juris Doctor Degree from Villanova University. David Fredrickson Executive Vice-President, Oncology Business Unit Dave is responsible for driving growth and maximising the commercial performance of the AstraZeneca global Oncology portfolio. Before joining AstraZeneca, Dave worked at Roche/ Genentech, where he served in several functions and leadership positions. Dave is a graduate of Georgetown University in Washington DC. Iskra Reic Executive Vice-President, Vaccines & Immune Therapies Iskra is Head of the Vaccines & Immune Therapies business unit. Established in 2021, during AstraZeneca’s industry-leading response to the COVID-19 pandemic, Vaccines & Immune Therapies is focused on developing transformative vaccines and immune therapies to prevent infectious diseases globally. Iskra trained as a doctor of Dental Surgery at the Medical University of Zagreb and has an MBA from the IEDC-Bled School of Management. Pam Cheng Executive Vice-President, Global Operations, IT and Chief Sustainability Officer Pam joined in 2015, after 18 years with Merck/MSD in Global Manufacturing. Pam has also worked for Universal Oil Products, Union Carbide Corporation and GAF Chemicals. She holds Bachelor’s and Master’s degrees in chemical engineering from Stevens Institute of Technology and an MBA from Pace University. Susan Galbraith Executive Vice-President, Oncology R&D Susan has global accountability for Oncology R&D from discovery through to late-stage development. Susan joined AstraZeneca in 2010, having previously worked at BMS. She graduated in medicine from Cambridge University, has a PhD from the University of London and qualified as a Clinical Oncologist in 2001. Leon Wang Executive Vice-President, International and China President Leon is responsible for driving sustainable growth across the International region, including China. China is now AstraZeneca’s third-largest market, and AstraZeneca is its largest pharmaceutical company. Leon holds an EMBA from China Europe International Business School, and a BA from Shanghai International Studies University. Marc Dunoyer CEO, Alexion and Chief Strategy Officer, AstraZeneca Marc served as AstraZeneca’s Chief Financial Officer until 2021. Previously, he served as Global Head of Rare Diseases at GSK and (concurrently) Chairman, GSK Japan. He holds an MBA from HEC Paris and a Bachelor of Law degree from Paris University. Menelas (Mene) Pangalos Executive Vice-President (formerly Executive Vice-President, BioPharmaceuticals R&D and SET member 2013-2023) Mene will retire from AstraZeneca in early 2024. Katarina Ageborg Formerly Executive Vice-President, Sustainability and Chief Compliance Officer; President AstraZeneca AB Sweden Katarina retired in January 2023. Further information about SET members is available on our website, www.astrazeneca.com. See Board of Directors biographies from page 78. 80 AstraZeneca Annual Report & Form 20-F Information 2023 Corporate Governance Senior Executive Team (SET) as at 31 December 2023 |
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Market definitions1 Region Country US US Europe Austria* Estonia* Ireland* Netherlands Slovenia* Belgium Finland Israel* Norway Spain Bulgaria* France Italy Poland Sweden Croatia Germany Latvia* Portugal* Switzerland Cyprus* Greece Lithuania* Romania UK Czech Republic Hungary Luxembourg* Serbia and Montenegro* Denmark Iceland* Malta* Slovakia* Established RoW Australia Canada Japan New Zealand* Emerging Markets Algeria Dominican Republic Kazakhstan Panama Tunisia* Argentina Ecuador* Kuwait Peru Turkey Aruba* Egypt Lebanon* Philippines Ukraine Bahamas* El Salvador Libya* Qatar* United Arab Emirates Bahrain* Georgia* Malaysia Russia Uruguay* Barbados* Guatemala Maldives Saudi Arabia Uzbekistan Belarus* Honduras Mexico Singapore Venezuela* Brazil Hong Kong Mongolia South Africa Vietnam* Brunei India Morocco* South Korea Yemen* Cambodia Indonesia Nicaragua Sri Lanka* Chile Iran* Oman* Sudan* China Iraq* Other Africa* Taiwan Colombia Jamaica* Pakistan* Thailand Costa Rica Jordan Palestine* Trinidad and Tobago* * Q3 2023 IQVIA, IQVIA Midas Quantum Q3 2023 data are not available or AstraZeneca does not subscribe for IQVIA quarterly data for these countries. 1 The above table is not an exhaustive list of all the countries in which AstraZeneca operates, and excludes countries with revenue in 2023 of less than $1 million. Established Markets means US, Europe and Established RoW. North America means US. Other Emerging Markets means all Emerging Markets except China. Other Africa includes Botswana, Ghana, Kenya, Mauritius, Namibia and Nigeria. US equivalents Terms used in this Annual Report US equivalent or brief description Accruals Accrued expenses Called-up share capital Issued share capital Earnings Net income Employee share schemes Employee stock benefit plans Fixed asset investments Non-current investments Freehold Ownership with absolute rights in perpetuity Loans Long-term debt Prepayments Prepaid expenses Profit Income Share premium account Additional paid-in capital or paid-in surplus (not distributable) Short-term investments Redeemable securities and short-term deposits Trade Payables Accounts payable Trade Receivables Accounts receivable 232 AstraZeneca Annual Report & Form 20-F Information 2023 Additional Information Glossary |
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EUROPE-LEGAL-286374707/1 106322-0213 AstraZeneca PLC Legal & Secretary’s Department 1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA For the attention of Adrian Kemp By email & by post Dear Ladies and Gentlemen BUREAU VERITAS STATEMENT OF ASSURANCE FOR ANNUAL REPORT AND FORM 20-F INFORMATION 2023 In connection with the anticipated filing by AstraZeneca PLC (“AstraZeneca”) of a Form 20-F with the U.S. Securities and Exchange Commission, Bureau Veritas hereby authorizes AstraZeneca to refer to Bureau Veritas’s external assurance on corporate responsibility related information as stated on page 230 and identified (highlighted in yellow) on the pages of the Annual Report and Form 20-F Information for the fiscal year ended December 31, 2023 (the “Annual Report”) annexed as Annex A, each of which is incorporated by reference in the registration statement No. 333-253315 on Form F-4 for AstraZeneca, in the registration statement No. 333-256406 for AstraZeneca on Form F-3, and in the registration statements No. 333-240298, No. 333-226830, 333-21 6901, No. 333-170381, No. 333-1 52767, No. 333-1 24689 and No. 333-09062 on Form S-8 for AstraZeneca. Our authorization is subject to AstraZeneca’s acknowledgement and agreement that: 1) Bureau Veritas has undertaken an independent review of the corporate responsibility information disclosed in the Annual Report and provided an opinion as to the accuracy and reliability of the information subject to the scope, objectives and limitations defined in the full assurance statement posted on AstraZeneca’s responsibility website; 2) AstraZeneca acknowledges and agrees that Bureau Veritas shall not be deemed an “Expert” in respect of AstraZeneca’s securities filings, and AstraZeneca agrees that it shall not characterize Bureau Veritas as such; and 3) AstraZeneca accepts full responsibility for the disclosure of all information and data, including that relating to Bureau Veritas, set forth in the Annual Report as filed with the SEC and agrees to indemnify Bureau Veritas from any third party claims that may arise therefrom. |
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EUROPE-LEGAL-286374707/1 106322-0213 Please indicate your agreement to the foregoing by signing in the space indicated below. Our authorization will not become effective until accepted and agreed by AstraZeneca. Very truly yours, /s/ David Murray Name: David Murray Title: Sustainability Services Manager For and on behalf of Bureau Veritas U.K. Ltd ACCEPTED AND AGREED This 20 day of February 2024 AstraZeneca PLC /s/ Adrian C N Kemp Name: Adrian C N Kemp Title: Company Secretary |
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Our strategic priorities Our priorities reflect how we are working to deliver our Growth Through Innovation strategy and achieve our Purpose of pushing the boundaries of science to deliver life-changing medicines. Science and innovation-led We use our distinctive scientific capabilities to deliver a pipeline of life-changing medicines. 178 projects in our development pipeline1 17 new molecular entities (NMEs) in our late-stage pipeline Leading in our Therapy Areas We are focused on areas where we can make the most meaningful difference to patients. Therapy Areas Oncology BioPharmaceuticals Rare Disease Total Revenue2 $45.8bn $45.8bn $44.4bn $37.4bn 2023 2022 2021 Diversified portfolio and global reach With a focus on patients, we have a global reach and a diversified portfolio of medicines across primary care, specialty care and rare diseases. Total Revenue by Therapy Area Oncology 40% BioPharmaceuticals 40% Rare Disease 17% Other Medicines 3% Total Revenue by reporting region US 42% Emerging Markets 26% Europe 21% Established Rest of World 11% Positively impacting people, society and the planet BV We are committed to operating in a way that recognises the interconnection between business growth, the needs of society and the limitations of our planet. 66.4m people reached by our access to healthcare programmes 67.6% reduction in Scope 1 and 2 GHG emissions since 2015 Rating of AA in the MSCI ESG Ratings assessment Top 20% of 2,500 of the world’s largest companies and Europe Index constituent 123 NME or major life-cycle management (LCM) projects in Phase II and Phase III 1 Includes NME and major LCM projects up to launch in all applicable major markets. AstraZeneca Annual Report & Form 20-F Information 2023 5 Strategic Report Corporate Governance Financial Statements Additional Information AstraZeneca at a Glance 1. Science and Innovation 2. Growth and Therapy Area Leadership 3. People and Sustainability We are a global, science-led, patient-focused pharmaceutical business. We are dedicated to transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. AstraZeneca at a Glance 2 Total Revenue includes revenues from Other Medicines. |
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2023 2022 2021 86% 86% 85% 86% Employee belief that AstraZeneca is a great place to work1 2023 25/27 2022 7/9 2021 10/12 Green Amber Red 25/27 Sustainability scorecard performance2 Our focus areas > Maintaining employee engagement by continuing to make AstraZeneca a great place to work. > Focusing on delivering our inclusion and diversity strategy, and learning and development programmes. > Ensuring we operate in the smartest way and increase the speed of delivery of medicines to patients through our business transformation programmes. > Playing our part in protecting the planet by realising our ambition to become carbon negative for all residual emissions from 2030. > Leading the way in our efforts to improve access to healthcare and build health system resilience. > Harnessing the power of science and innovation in ways that positively impact patients, healthcare systems and the environment. > Advancing our sustainability priorities, particularly health equity and health system resilience, as well as addressing the effects of the twin climate and nature crises and the impact on global health and healthcare. How our strategy responds to global trends To ensure we are able to deliver our strategy, build trust in AstraZeneca and contribute to the health of society and the planet, we are: > Creating an inclusive and equitable environment where people belong, using our diversity as a competitive advantage. > Fostering a culture of lifelong learning, strengthening and evolving our capabilities, and instilling confidence to challenge convention and explore possibilities. > Simplifying the way we work, driving productivity, and optimising digital and technology to deliver a better experience for our people and better outcomes for patients. > Working towards a future where all people have access to affordable, sustainable and innovative healthcare. > Playing our part in protecting the planet by reducing GHG emissions from our global operations and fleet by 98% by 2026 and halving our entire value chain footprint by 2030. > Empowering employees through our Code of Ethics to make decisions in the best interests of the Group and society. How we progressed in 2023 > We continued to invest in our people to ensure we recruit, retain and develop a talented workforce. > In 2023, we delivered a strong performance across the key priorities of our People and Sustainability strategy pillar. > We continued to score highly in our Pulse surveys for questions relating to our Purpose, direction, patient centricity and employee commitment to our success. > We demonstrated our continued commitment to investing in global collaborations, Group initiatives, and local partnerships to strengthen health systems. > We maintained a leading role in industry efforts to address the effects of climate change on our planet and accelerate the delivery of net-zero healthcare, while improving health outcomes and reducing our environmental impact. > Our Ambition Zero Carbon strategy delivered further reductions in our GHG emissions across our value chain – Scopes 1, 2 and 3 – and we are on track with our environmental commitments. 2030 Bold Ambition workstreams Accelerating thinking around our initiatives, exploring new ones and identifying the best ways to grow the business: > Employee experience – being a great place to work, where people feel a sense of community, collaboration and purpose. > Sustainability – going ‘beyond climate’ to drive a nature restoration approach to all we do, while ensuring that the most vulnerable people in society have access to our medicines. > Technology – identifying, prioritising and adopting leading-edge technologies, while upskilling and empowering our people to drive productivity. > Axial project – rethinking how we manage our supply chains, manufacturing, customer experience, financial reporting, financial planning and people management. > Business transformation – smarter, more innovative ways of working and exploring how we can become more productive. People and Sustainability Key Performance Indicators BV Our People and Sustainability strategy is built around two priorities: Contribution to the enterprise and Contribution to society. Our Contribution to the enterprise KPI is based on our Pulse survey measure of those employees who believe that AstraZeneca is a great place to work. Our Contribution to society KPI is based on our sustainability scorecard. Ratings for this KPI reflect our success in achieving our sustainability goals. Our 2023 scorecard is based on nine focus areas that guide our sustainability strategy and show where we can have the most positive impact. These are detailed in our Sustainability Report: www.astrazeneca.com/sustainability. 2 In 2023, we assessed our performance against 27 publicly available targets across our three integrated sustainability priority pillars. At least 90% of targets need to be ‘on plan’ to achieve a scorecard rating of green; at least 70% for amber; and red signifies any percentage below this. 1 Source: November Pulse survey for each year. “We’re unlocking the power of what science can do for people, society and the planet.” For more information, see People and Sustainability from page 46. For more information on our KPIs, including definitions, methodology and restatements, see our Sustainability Data Summary at www.astrazeneca.com/ sustainability. AstraZeneca Annual Report & Form 20-F Information 2023 15 Strategic Report Corporate Governance Financial Statements Additional Information Our Strategy and Key Performance Indicators |
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Science and Innovation Research use of human biological samples and genomic information We use human biological samples and genomic information for research into better understanding of diseases, improved diagnosis, and other healthcare improvements, as well as for the research and development of new medicines. We are committed to minimising the use of human foetal tissue (hFT) through scientific advancements. Permission is granted only when no other scientifically reasonable alternative is available, or there is a regulatory requirement. There were two new hFT approvals in 2023. To date, eight projects using hFT have been approved, and three projects are ongoing. Animals in research Animal studies remain a small, but necessary part of discovering, developing and licensing life-changing medicines. AstraZeneca is committed to the 3Rs (Replacement, Reduction and Refinement of animals in research) and has programmes to accelerate the development of new approach methodologies, which have potential to reduce and eventually replace the need for animals. We focus on robust experimental design and analysis to ensure the fewest animals are needed to achieve scientific objectives, with our scientists refining procedures and applying high standards of animal care. Animals were needed for in-house studies 122,768 times in 2023 (100,803 in 2022), and on our behalf in contract research studies 59,690 times (53,377¹ in 2022). In total, over 97% were rodents or fish, with the majority being mice (84%). The remainder is made up of rabbits, camelids, ferrets, dogs, pigs, non-human primates, chickens and sheep. Dogs and non-human primates make up less than 1% of the total. AstraZeneca does not conduct research using wild-caught non-human primates or great ape species. AstraZeneca is committed to transparency and is signatory to the Concordat on Openness on Animal Research (UK), the Openness Agreement on Animal Research and Teaching (Australia/New Zealand) and is contributing to the U.S. Animal Research Openness Initiative. AstraZeneca has an animal welfare assurance programme that ensures research conducted by third parties meets our high standards. Clinical trial transparency We believe that transparency enhances the understanding of how our medicines work, which benefits patients. We publish information about our clinical research, as well as the registration and results of all our interventional clinical trials and most non-interventional trials for all products – regardless of whether the results are favourable. This includes completed trials for marketed medicines, drugs in development and drugs where development has been discontinued. As of 31 December 2023, AstraZeneca had: > Shared anonymised individual patient-level data from 270 unique studies. > Responded to 364 requests from external researchers using our portal, www.vivli.org, and/or scientific collaborations, for our clinical data and reports to support their research. > Published 23 Anonymised Clinical Document Packages. > Published 401 Trial Result Summaries in accessible language and translated these into 63 languages for all study sites on the industry-wide portal www.trialsummaries.com. Bioethics ‘Bioethics’ means ethical issues arising from the study and practice of biological and medical science. Our key principles are set out in our Global Standard. BV For more information, see www.astrazeneca.com/ sustainability/resources.html. Business Review continued Driving innovation in clinical trials We are pioneering new approaches to clinical trials. By integrating data science, digital health technology and AI, we focus on clinical innovation to transform study design, improve patient outcomes, accelerate timelines, reduce burdens on patients and trial teams, and improve environmental sustainability. 1 2022 data has been restated due to system error causing figures to be overstated. 36 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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Established Rest of World (RoW) Established RoW comprises Japan, Canada, Australia and New Zealand. In 2023, Total Revenue decreased by 14% (8% at CER) to $5,099 million, with sales in Japan down 10% (3% at CER) to $3,705 million. Emerging Markets With Total Revenue of $12,025 million, up 2% (9% at CER), AstraZeneca was the second-largest multinational pharmaceutical company, as measured by prescription sales, and the fifth fastest-growing top 10 multinational pharmaceutical company in Emerging Markets in 2023. In China, AstraZeneca is the largest pharmaceutical company in the hospital sector, as measured by sales value. In 2023, Total Revenue increased by 1% at actual rate of exchange (7% at CER) to $5,876 million (2022: $5,792 million). Roxadustat and Lokelma were renewed in the National Reimbursement Drug List (NRDL) and Xigduo, Tagrisso (ADAURA), Lynparza (PAOLA-1), Calquence, Soliris and Koselugo achieved listing for the first time. Since the implementation of VBP, several AstraZeneca brands have been impacted. In the most recent cycles of VBP implementation, Faslodex and Plendil were included. Additional AstraZeneca brands are expected to be included in future VBP cycles. There was some impact on demand in the second half of the year, mainly with oncology products, following the government anti-corruption campaign announced in July 2023. We were shocked following the Russian invasion of Ukraine in February 2022 and, since then, have provided practical support to ensure the safety, health and wellbeing of our employees. As a healthcare business, we are doing everything possible to ensure medical supply chains continue to operate and that patients in both countries are able to access our medicines, while complying with sanctions imposed on Russia. Healthcare in low- and middle-income countries BV AstraZeneca is committed to building resilient and sustainable health systems and improving equitable access to healthcare. By working collaboratively, we remove barriers to care and support the development and delivery of healthcare, particularly in low- and middle-income countries. We also adapt our programmes to suit local health systems and communities, contributing to health system capacity and resilience through training, education, prevention and early detection and diagnosis. AstraZeneca in Japan We are the second-largest prescription-based pharmaceutical manufacturer with a 6.1% value market share of Innovative Branded pharmaceutical sales by value, and have gained recognition as being a great place to work by the Great Place to Work Institute. Pricing and value of our medicines Increasing demand for healthcare means increasing pressure on health system budgets. This shift results in price and reimbursement restrictions in many markets. These pressures also result in movement from primary to speciality care, including rare diseases, which comprise a growing share of our portfolio. This pricing pressure, coupled with higher rates of inflation, means that we are unable to pass on the full impact of price increases. Pricing for our medicines seeks to reflect the value they bring to patients, payers and society, and the significant investment required for targeted treatment options. In our discussions with national, regional and local stakeholders, we base our pricing policies on four principles: sustainability, value, access and flexibility. We collaborate with payers to conclude innovative outcomes and value-based reimbursement models that improve patient outcomes and enable access to medicines across key therapeutic areas and geographic regions. We also offer a number of patient assistance programmes that help increase patients’ access to medicines and/or healthcare by reducing their cost burden. Responsible sales and marketing BV As outlined in the Code of Ethics on page 49, we are committed to high ethical standards. Our compliance professionals advise on, and monitor, adherence to our Code and policies, and work with local staff to ensure we meet our ethical standards. Nominated signatories review product promotional materials and activities to ensure compliance with applicable regulations and codes of practice, and that information is accurate and balanced. Group Internal Audit conducts audits of selected marketing companies. In 2023, we identified four confirmed external breaches across our Commercial business (2022: 10). There were 3,758 instances (instances can involve multiple people) of employee and third-party non-compliance with our policies (2022: 2,872). A total of 296 employees and third parties were removed from their role as a result of a breach (2022: 147) and 2,968 received warnings (2022: 3,326). We brief our Audit Committee quarterly on breach statistics, serious incidents and corresponding remediation. Breaches primarily consist of low-impact incidents. We continue to foster a culture where employees can speak their minds, with strong first-line oversight (and related reporting) as well as targeted second-line monitoring to identify concerns early, and use learnings to improve our programme. Anti-bribery and anti-corruption BV We do not tolerate bribery or any other form of corruption. Preventing bribery and corruption are a focus of our third-party risk management and due diligence processes, as well as our monitoring and audit programmes. We reinforce our commitment to ethical business conduct through our annual Code of Ethics training, which is delivered to all employees and relevant third parties. For more information, see Access to healthcare from page 47. For more information on our pricing policies, see our Sustainability Report on our website, www.astrazeneca.com/ sustainability. Business Review / Growth and Therapy Area Leadership AstraZeneca Annual Report & Form 20-F Information 2023 39 Strategic Report Corporate Governance Financial Statements Additional Information |
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Operations Our manufacturing and supply function continued to support our growth and pipeline, demonstrating excellence in product launches, quality and supply, with focus on progressive, sustainable processes. In 2023, we made strong progress against our Operations 2025 strategy, focused on scaling our capabilities to support business growth, leveraging the benefits of new manufacturing technology and digital innovation: > Delivered 282 launches across major markets. > Progressed our investments in manufacturing technologies, new modalities and digital innovations. > Five sites within the network – Nijmegen, Cairo, Cikarang, Lomas Verdes and Cotia – have delivered a 98% reduction in Scope 1 and Scope 2 GHG emissions (from 2015 baseline) measured against science-based targets. Ensuring quality and compliance As outlined in our Code of Ethics on page 49, we are committed to high ethical standards. As members of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), we adhere to their codes. Managing our supply chain During 2023, the world environment continued to be volatile and uncertain. The geopolitical events, trade sanctions, regulatory changes and high inflation are types of challenges that continue to require rapid operational responses. We continued to successfully meet our responsibilities to patients ensuring supply of our life-saving medicines with robust supply chain operations and reduced end-to-end supply lead times. We delivered increased demand and growth opportunities with flexibility and agility. As the regulatory environment evolves post COVID-19, AstraZeneca continues to deliver industry-leading quality performance. FDA recall data from 2020 to 2023 showed that AstraZeneca had zero recalls during this period. Supply chain finance AstraZeneca has a supply chain finance programme to support the cash flow of our external supply base. The programme is managed by Taulia Inc. (with funding provided by some of the Group’s relationship banks) and provides suppliers with visibility of invoices and payment dates via a dedicated platform. Suppliers can access this platform free of charge and have flexibility to select individual invoices for early payment. On election of an early payment, a charge is incurred by the supplier based on the period of acceleration, central bank interest rate and the rate agreed between Taulia Inc. and each supplier. All early payments are processed by the funders and AstraZeneca settles the original invoice amount with the funders at maturity of the original invoice due date. The programme operates in the US, UK, Sweden and Germany. As at 31 December 2023, the programme had 432 suppliers enrolled and a potential early payment balance of $112 million. We have a separate programme in China with 29 suppliers enrolled and a potential early payment balance of $11 million. Responsible supply chain BV All employees and contractors who source goods and services on behalf of AstraZeneca are expected to follow our Global Standard for Procuring Goods and Services. Through assessments and improvement programmes, including our third-party risk management system, we monitor supplier compliance with our published Global Standard on Expectations of Third Parties and Code of Ethics. In 2023, we conducted 47 audits (2022: 42) on high-risk commercial suppliers (external manufacturing partners) to ensure appropriate practices and controls. Of these, 50% fully met our expectations while 45% had improvement plans for minor instances of non-compliance. There were two audits indicating a high risk to AstraZeneca and action has been taken to mitigate these supply and/or reputational risks. We also use EcoVadis scores to assess and improve supplier sustainability performance. Our Sustainable Procurement Programme embeds responsible sourcing practices and promotes ethical behaviour, aiming to achieve 100% ethical spend with suppliers who share our Values. This fosters their progress on sustainability, enables us to innovate together and accelerates supplier diversity. Our Supplier Diversity Programme maximises opportunities for small and diverse businesses to be part of our value chain and supports their growth. In 2023, we reached our ambition to have active supplier diversity programmes in 10 countries outside the US by 2025, with Switzerland, Ireland and Canada joining Brazil, South Africa, the UK, Australia, New Zealand, Poland and Sweden. Global manufacturing capability Our principal tablet and capsule formulation and packing sites are in the UK, Sweden, China, Puerto Rico and the US, with local supply sites in Egypt, India, Japan and Russia, and regional supply sites in Brazil, Indonesia, France and Mexico. We also have major formulation sites for the global supply of parenteral and/or inhalation products in the US, Sweden, France, Australia and the UK. Most of the manufacture of active pharmaceutical ingredients (APIs) is delivered through the efficient use of external sourcing that is complemented by internal capabilities. For biologics, our principal commercial manufacturing facilities are in the US, Sweden, the UK and the Netherlands. Our network contains capabilities in process development, drug substance, drug product manufacturing and distribution, including global supply of mAbs and influenza vaccines. In January 2023, we finalised the sale of our West Chester site in Ohio, US, to National Resilience, Inc. This enabled the continued supply of AstraZeneca medicines produced at the site to patients, as well as continued employment for more than 500 people working at the site. We continue to pursue growth opportunities in China. In March 2023, we announced plans for a new facility in Qingdao to manufacture pressurised metered-dose inhalers (pMDIs) for respiratory products. In May 2023, AstraZeneca leased a facility in Rockville, Maryland, US. This facility will be fitted out for cell therapy manufacture to support clinical and commercial supply. In October 2023, we announced our intent to exit our supply site in Bangalore, India. Alexion has internal manufacturing facilities and also works with third-party contract manufacturers to supply clinical and commercial quantities of our products and product candidates. Our internal manufacturing capability includes a fill/finish facility at our Athlone site and a packaging and labelling facility at our Dublin site. Our drug substance manufacturing capabilities are shared between Athlone and Dublin and we have a large-scale drug substance facility in Dublin. At the end of 2023, we employed 15,609 people at 27 Operations sites in 16 countries. Growth and Therapy Area Leadership 40 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Business Review continued |
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-67.6% -58.7% -58.0% 2023 2022 2021 -67.6% Ambition Zero Carbon (Scope 1 and 2)1 2023 2022 2021 66.4m 44.6m 31.7m 66.4m People reached by our access to healthcare programmes3 2023 2022 2021 83% 83% 83% 83% % Speak up culture2 Business Review / People and Sustainability 2023 2022 2021 76% 77% 78% 76% Performing as an enterprise team1 88% Building a culture of lifelong learning and development2 88% 89% 88% 2023 2022 2021 50.1% Being champions of inclusion and diversity3 50.1% 49.5% 48.1% 2023 2022 2021 People and Sustainability Our performance in 2023 BV > Fully integrated Alexion employees. > Hired 25,660 employees (7,727 internal and 17,933 external). > 5,290 of these hires were a direct result of our employee referral scheme. > 4,401 employees attended a development programme (an increase in participation of 9% since 2022). > 50.1% of our senior middle management roles are filled by women. > Announced three ground-breaking renewable energy initiatives. > Reached 66.4 million people through our flagship access to healthcare programmes. > Published 2023 Partnership for Health System Sustainability and Resilience (PHSSR) Summary Report and expanded the programme in Asia-Pacific. > Reduced Scope 1 and 2 GHG emissions by 67.6% from 2015 baseline year. > Raised AZ Forest commitment to 200 million trees planted and stewarded by 2030 (from 50 million by 2025). Summary and performance indicators Our success depends on recruiting, retaining and developing talented people while operating in a responsible and sustainable way. Performance indicators BV People – Contribution to the enterprise This priority is built on three pillars: performing as an enterprise team, commitment to lifelong learning and development, and being champions of inclusion and diversity. Performance indicators BV Sustainability – Contribution to society We are tackling some of the biggest issues of our time, from climate change to access to healthcare and disease prevention. 1 Reduction of Scope 1 and 2 GHG emissions from 2015 baseline year. The data for 2021 and 2022 has been restated due to a site divestment and change in methodology. 3 Cumulative data including current and historical programmes: Healthy Heart Africa, Young Health Programme, Healthy Lung and Phakamisa. 2 Based on internal survey which asked all AstraZeneca employees if they felt comfortable to speak up/speak my mind and express my opinion at work. For more information, see People from page 44 and Sustainability from page 46. 1 Source: November Pulse full census survey for each year, based on the percentage of favourable responses to the statement ‘Based on my experience, I believe there is effective collaboration between teams across AstraZeneca’. 2 Source: November Pulse full census survey for each year, based on the percentage of favourable responses to the statement ‘In the last 12 months, I have improved my existing skills, or learned new skills, or had a development opportunity’. 3 Female representation in senior middle management roles and above (F+, the most senior 16% of the employee population). AstraZeneca Annual Report & Form 20-F Information 2023 43 Strategic Report Corporate Governance Financial Statements Additional Information |
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everyone feels valued and respected because of their individual abilities and perspectives. In 2023, our I&D efforts earned recognition externally. We were featured in: > Forbes World’s Top Companies for Women > Forbes World’s Best Employers > Financial Times, Diversity Leaders > Diversity Inc. Top 50 Companies for Diversity (US) > TIME World’s Best Companies. Human rights BV Our human rights principles support the basic rights of all people, such as the right to health, freedom from slavery, and privacy. Our Code of Ethics, Human Rights Statement and Expectations of Third Parties commit us to respecting and promoting international human rights, both within our own operations but also our wider spheres of influence. This includes working only with third parties who share our approach. To that end, we integrate human rights considerations into our processes and practices. We are also committed to ensuring that there is no modern slavery or human trafficking in our value chains, or any part of our business. Our human rights policies are designed to ensure we consider the impact of our operations including our interactions with third parties on human rights. The output of our work to mitigate human rights risks is detailed in our Modern Slavery Statement which is published annually. We provide assurance annually to the Audit Committee. Employee relations BV Our Employee Relations function takes a global approach to employment principles and standards, local laws and good practice. Our ambition is to build a positive and safe working environment for employees through global policies and processes. To achieve this, our Employee Relations function works in partnership with Legal, Compliance, HR and Employee Representative groups, such as the European Consultation Committee, works councils and unions. According to our biennial Human Rights survey, the most recent of which was carried out in 2022, 45% of our countries have a relationship with trade unions. Champions of inclusion and diversity Our global commitment to inclusion and diversity (I&D) is woven into everything we do, and is reflected in our Values and the behaviours that underpin them. Women comprise 53.9% (approximately 47,800) of our global workforce. At the end of 2023, there were six women on our Board (46.2% of the total). Following the retirement of Katarina Ageborg in January 2023 and the appointment of Sharon Barr as Executive Vice-President, BioPharmaceuticals R&D in August 2023, five out of 12 SET members (41.7%) were women at the end of the year. Mene Pangalos will be retiring in early 2024. Our employees represent a diverse range of backgrounds, coming from 179 countries. In 2023, to promote inclusion and diversity, we have established the Global Inclusion and Diversity Ambassador Group, which is led by senior leaders and sponsored by our CEO. This group reflects the diversity of our global workforce and organisational structure. They are responsible for collaborating with local leaders to customise approaches that address local needs and drive progress towards our global inclusion and diversity commitments. Our Board of Directors and the SET conduct biannual and quarterly reviews, respectively, of our workforce composition, covering gender, ethnicity and age representation. In the US, where we have more comprehensive data available, 36.7% of our workforce identify as an ethnic minority (2022: 35.7%). In 2023, we rolled out pay equity training to all line managers of US-based employees to ensure equitable reward and compensation. We are committed to hiring and promoting talent ethically and in compliance with applicable laws. Our Code of Ethics (the Code) and its supporting Standards are designed to help protect against unlawful discrimination on any grounds, including disability. The Code covers recruitment and selection, performance management, career development and promotion, transfer, training (including, if needed, for people who have become disabled), and reward. AstraZeneca embraces the cognitive differences of neurodivergent employees and supports employees with both seen and unseen disabilities in line with their country-specific laws and regulations. Where risk assessments can be performed, we will consider accommodating adjustments to the working environment that support an inclusive and safe workplace. Our Global Standard for Inclusion and Diversity sets out how we foster an inclusive and diverse workforce where Of those countries that do not have a relationship with trade unions, 95% of them have established arrangements to engage similarly with their workforce. Workforce safety and health BV We are committed to providing a safe and healthy working environment for our employees and partners. Our Global Safety, Health and Environment (SHE) Standard describes our commitment to, management of, and accountability for SHE. We set and monitor our safety and health targets to support our workforce and aim to achieve the highest performance standards. Our work-related injury rate reduced by 59.6% from the 2015 baseline. AstraZeneca responded to an increasing collision trend in 2022 by developing a safe driving campaign and training endorsed by the Commercial SHE Executive Committee. This campaign continued into 2023 and has shown a positive impact on collisions per million kilometres (CPMK). In 2023, the CPMK was 1.96, exceeding the 2.5 target for the year and on course to meet or exceed the target for 2025 of 1.90. For more information on our standards and Code of Ethics and for our full statement detailing how we work to mitigate the risks of modern slavery, see our website, www.astrazeneca.com/ sustainability/resources.html. Business Review / People and Sustainability AstraZeneca Annual Report & Form 20-F Information 2023 45 Strategic Report Corporate Governance Financial Statements Additional Information |
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People and Sustainability Access to healthcare Environmental protection Ethics and transparency Equitable access Affordability and pricing Health system resilience Ambition Zero Carbon Product sustainability Natural resources Ethical business culture Inclusion and diversity Workforce safety and health Our approach to sustainability Our Purpose to push the boundaries of science to deliver life-changing medicines is underpinned by our commitment to contribute sustainably to people, society and the planet. As a global business, we are playing our part by operating ethically and responsibly, and helping tackle the biggest challenges of our time, including climate change, biodiversity loss and global health equity. These challenges are interdependent and require collaboration to be successfully addressed, implementing a variety of approaches across a network of relationships. By working together to find science-based solutions, we believe we can drive real change and build a better future. Governance Our sustainability strategy is developed by the SET, which reviews our sustainability scorecard quarterly, and is approved by the Board. Our Board Sustainability Committee monitors the execution of the sustainability strategy, overseeing the communication of our activities with stakeholders, and providing input to the Board and other Board Committees as required. Overview We seek to create value beyond the impact of our medicines by embedding sustainability into everything we do – from the lab to the patient – and by supporting health system resilience to make sustainable healthcare available to all. During 2023, we were recognised for our efforts across all our sustainability priorities, including: > AstraZeneca received a rating of AA (on a scale of AAA-CCC) in the MSCI ESG Ratings assessment. > Included in Dow Jones Sustainability Index Top 20% of 2,500 of the world’s largest companies and in Europe Index. > Listed in Financial Times European Climate Leaders for the third consecutive year. > Included in Forbes World’s Top Companies for Women. Benchmarking and assurance We contribute to key global environmental, social and governance (ESG) performance evaluations, recognising the value of independent third-party assessment and insights. Our performance is also assessed independently based on the information and data we make publicly available. Bureau Veritas has provided limited independent assurance for the sustainability information contained within this Annual Report and Form 20-F. Assurance is in accordance with the International Standard on Assurance Engagements (ISAE) 3000 (Revised) and ISAE 3410 Assurance Engagements on Greenhouse Gas (GHG) Statements. Sustainability strategy We assess the relevance of our material focus areas through continuous dialogue with our stakeholders and horizon-scanning for developments. Since 2021, our nine priority focus areas have been grouped under three interconnected strategic priority pillars: Sustainability Sustainability at AstraZeneca means harnessing the power of science and innovation, and our global reach, to build a healthy future for people, society and the planet. BV Driving emissions reductions with clean heat and renewable energy The research, development and production of medicines is an energy intensive process. We are decarbonising our operations as we transition to net zero: in the UK and in the US, we will use renewable natural gas, or biomethane, to supply clean heat to our sites. For more information, see: Our Sustainability Report on www.astrazeneca.com/ sustainability/resources.html. The letter of assurance in the Annual Sustainability Report section on www.astrazeneca.com/ sustainability/resources.html. Board Sustainability Committee Report on page 93. Sustainability supplementary information on page 230. Business Review continued 46 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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As we expand the geographies where our rare disease medicines are available, we continue to build relationships with patient communities early in our development programmes to better understand their needs. We focus on: increasing clinical trial diversity; developing improved data collection processes to enhance our understanding of how rare diseases affect specific patient populations; improving access to diagnostic tools; and supporting efforts to improve the experience of those participating in our clinical trials. We also supply medicines for rare diseases through patient support and access programmes. Improving access to digital solutions Through our A.Catalyst Network innovative partnerships, we are harnessing the latest technologies to improve patient outcomes, make healthcare more accessible and personalised, and drive efficiencies in health systems. As participants in EDISON Alliance’s One Billion Lives Challenge, we aim to screen five million patients for lung cancer risk by 2025, using AI-based technology in collaboration with Qure.ai. Affordability and pricing We are committed to addressing barriers to access and affordability. Industry, policymakers and payers need to work together to identify solutions. Through collaborations, partnerships and stakeholder coalitions, we are working to ensure essential and innovative medicines become more widely available. Health system resilience Sustainable healthcare for all requires stronger health systems to deliver an infrastructure designed to be resilient, inclusive and responsive to the needs of the population it serves. We are investing in ground-breaking global collaborations, driving multisectoral policy and action, empowering local partnerships and fast-tracking innovation to expand access to higher quality healthcare. Partnership for Health System Sustainability and Resilience (PHSSR) The PHSSR is a non-profit, multisector, global collaboration with a unified goal of building more sustainable and resilient health systems, active in more than 30 countries. PHSSR has commissioned over 20 research reports to date, providing independent, evidence-based recommendations to strengthen health systems and facilitate cross-border best-practice sharing, working with national experts with first-hand experience. In 2023, PHSSR published its second Summary Report with insights from 18 countries, and launched research on seven new Asia-Pacific countries. PHSSR also established an EU expert advisory group, to support EU policymakers in improving policies on prevention and early detection of NCDs. By fostering joint learning and action through high-level stakeholder engagement at over Access to healthcare BV We want to secure a future where all people have access to affordable, sustainable and innovative healthcare, throughout the patient care pathway, from prevention, early detection and diagnosis, to the effective treatment of disease. We are working to remove barriers, deliver innovative medicines and strengthen health system infrastructure and resilience through global and local partnerships, across all our focus areas. Achievements in 2023 > We reached more than 66 million people (cumulatively) through access to healthcare programmes. > Healthy Heart Africa trained more than 11,300 healthcare workers (cumulatively) and conducted more than 47 million screenings (cumulatively) for elevated blood pressure. > Young Health Programme directly reached more than 15 million young people (cumulatively) and trained over 580,000 as Peer Educators since launch in 2010 in more than 40 countries. > We reached more than 13 million people (cumulatively) through our patient access programmes, enabling sustainable access to AstraZeneca medicines in around 25 countries, most of which were low- and middle-income countries. Equitable access Your health should not be determined by who you are, where you live or where you were born. We are working to remove barriers to healthcare and give everyone the chance to be as healthy as possible. Diversity in clinical trials We are committed to designing clinical programmes with equity at the forefront, from idea inception to patient care. Our approach is patient-centric, data-driven and science-led. We are improving the diversity of clinical trial participants with strong data foundations, tools and standards for aligning and tracking progress, and external partnerships. We work with industry groups, regulatory agencies, and local community groups to shape clinical trial diversity policies for the future, while delivering for patients today. Rare diseases More than 10,000 rare diseases are estimated to exist today, but fewer than 10% have approved treatment options. Rare disease community members face many unique challenges in pursuing equitable access to healthcare, such as significant delays in diagnosis, greater chances of hospitalisation from preventable conditions, scheduling and travelling to appointments, and accessing available treatments. We believe people with rare diseases deserve the same attention and investment to find and access therapies as anyone else. 40 global, regional and national platforms, the PHSSR catalysed efforts to strengthen health systems around the world. Healthy Heart Africa programme Our Healthy Heart Africa programme is committed to reducing hypertension and the burden of cardiovascular disease, aiming to reach 10 million people with elevated blood pressure across Africa by 2025. We work with local and global partners to raise awareness and offer training, screening and reduced cost treatment, where applicable. In 2023, the programme launched in eight of 10 planned grant countries, in addition to the existing nine countries of operation. Young Health Programme The multi award-winning Young Health Programme (YHP) aims to empower young people to make more informed choices about their health and catalyse a global, youth-led advocacy movement, supported by community programmes and research. It helps to develop young leaders and is focused on vulnerable and under-resourced communities in 40 countries. Through partnerships with more than 60 non-profit partners around the world including UNICEF, the YHP promotes health literacy and policy action. In 2023, the YHP won the Better Society Award for Partnership with an International Charity together with UNICEF. Community investment Community investment at AstraZeneca is built upon the principles of equity, transparency and partnership, working together to build healthy and resilient communities. In 2023, we contributed $115.4 million in financial and non-financial donations, (including product donations), to more than 810 non-profit partners across 76 countries. We also donated $4.7 billion (2022: $3.1 billion) of medicines through patient assistance programmes around the world, the largest of which is our AZ&Me Prescription Savings Program in the US. Product donation programmes In 2023, we gave $7.5 million (2022: $12.1 million) in product donations for disaster, humanitarian relief and public health need. We are committed to working with all health system stakeholders to enable the supply of medicine to patients and to support the resilience and recovery of healthcare facilities in vulnerable communities. For more information, see: Pricing and value of our medicines on page 39. Rare Disease from page 28. Qure.ai case study on page 19. AstraZeneca Annual Report & Form 20-F Information 2023 47 Strategic Report Corporate Governance Financial Statements Additional Information Business Review / People and Sustainability |
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Longer-term targets: > 50% reduction in total Scope 3 GHG emissions by 2030 and 90% reduction by 2045, from 2019 baseline. > Carbon negative for all residual emissions from 2030 and science-based net zero by 2045. > Transition to next-generation respiratory inhalers with near-zero climate impact propellant across our portfolio by 2030. > Plant and maintain 200 million trees by 2030, through our global AZ Forest initiative. Our goal of becoming carbon negative across our value chain from 2030 recognises that total emissions from value chain partners are significantly larger than from our own direct operations. We are embedding net-zero assessments into our existing and future product portfolios, engaging our suppliers to reduce their direct emissions through to 2030 and identifying carbon removal options. Product sustainability People and the planet will benefit from those medicines that have the smallest possible environmental impact, yet maintain the highest efficacy and safety standards. As technologies and healthcare systems evolve, so should solutions to reduce the use of energy, water and material, as well as waste and pollution generated from designing, manufacturing and delivering medicines to patients. We are using a data-driven approach through our Life Cycle Assessment (LCA) and Product Sustainability Index programmes to address the largest contributor to our Scope 3 emissions: our product value chains. In 2023, we continued to focus on the next-generation propellant transition for pMDI products in our respiratory portfolio. The new propellant HFO-1234ze(E) has up to 99.9% lower GWP than propellants currently used in respiratory medicines. As essential, life-saving medicines for millions of respiratory patients globally, they are strategically important to our business and a key product-related element of Ambition Zero Carbon. In 2023, project milestones achieved included further Phase III investment decisions, a harmonised, global development programme, readouts of pivotal studies and initiation of key registration studies. As part of our commitment to drive thought leadership and innovation to manage pharmaceuticals in the environment, we lead the Innovative Health Initiative PREMIER project, a partnership between the European Commission and the EFPIA. We are developing tools to identify potential environmental risks of APIs and make data more accessible to all stakeholders. In 2023, PREMIER published an evidence-led prioritisation of environmental data generation, aiming to reduce reliance on fish studies. Natural resources The conservation and sustainable use of natural resources and the protection and restoration of ecosystems are vital for a healthy future and to tackle the environmental drivers of disease. We are investing in nature to benefit planetary and societal health, while working towards sustainable resource use, water security and halting and reversing biodiversity loss. Our targets aim to decouple water use and waste generation from business growth and to minimise environmental impacts from our supply chain and operations, supported by efficiency projects, collaboration with suppliers on responsible sourcing, designing out waste and pollution, and landscape restoration targets via AZ Forest. Circular economy Adopting circular business approaches and implementing efficient processes to develop and produce our medicines are key to reducing natural resources used in our value chains. We are leveraging our experience with Lean manufacturing and embedding best practices, working with organisations such as My Green Lab. In 2023, we introduced a new internal Site Waste Circularity Rate metric to drive improvements through increased recycling and the external reuse or repurposing of waste materials across all our sites. Water stewardship We continue to work with key stakeholders, including our ongoing collaboration with the World Wide Fund for Nature Sweden. Starting in 2024, we will invest $5 million per year to fund nature restoration and water stewardship projects in the communities where we operate. AZ Forest In 2023, we announced an increase in our investment to $400 million in our global AZ Forest programme, to plant 200 million trees by 2030 and ensure their long-term survival. This includes new or expanded projects in Brazil, India, Vietnam, Ghana, Rwanda and Kenya, which will contribute to our climate action, promote the restoration of biodiversity and natural habitats, and build community resilience. The programme is expected to restore more than 100,000 hectares worldwide, positively impacting an estimated 80,000 livelihoods and local communities. We are led by guiding principles that provide a baseline for project design and a consistent approach that follows the science. We do not purchase land for reforestation or own the trees, but have the rights to carbon certificates generated by some projects. In 2023, we planted over nine million trees using locally-appropriate species. Sustainability continued BV Environmental protection BV A healthy environment is critical for human health and health system resilience, already impacted by climate change and the degradation of ecosystems. Science-led climate action and investments in nature and biodiversity are vital to improving health outcomes and proactively managing our environmental impact. Through our Natural Resource Efficiency Fund, we have invested approximately $175 million in environmental efficiency innovations since 2015. This, together with other central capital investments, has seen a further $36.6 million spent in 2023, including 72 new projects. Achievements in 2023 > 67.6% reduction in Scope 1 and 2 GHG emissions since 2015. > 17.5% reduction in energy consumption since 2015. > 19.9 million trees planted by AZ Forest since 2020. > 19.5% reduction in water usage and 13.2% reduction in our waste since 2015. > 99% safe API discharges for AstraZeneca sites and 94% safe API discharges for globally managed first-tier supplier sites. > 97.6% of paper-based product packaging materials used in 2022 (data collated in 2023) confirmed as supplied from sustainable sources. Ambition Zero Carbon Approximately 5% of global GHG emissions come from the healthcare sector. We are accelerating the delivery of net-zero healthcare and our own progress towards net zero, as one of the first companies to have our Scope 1, 2 and 3 targets verified under the Science-Based Targets initiative Net-Zero Corporate Standard. Near-term targets: > 98% absolute reduction in Scope 1 and 2 GHG emissions by 2026 from 2015 baseline, maximising transition to electric vehicles in our road fleet (EV100) by end of 2025 and using 100% renewable energy (RE100) for electricity and heat by end of 2025. > Reduce energy consumption by 10% and double energy productivity (EP100) from 2015 to 2025. > Launch first next-generation respiratory inhalers with near-zero climate impact propellant from 2025. > 95% of our suppliers by spend covering purchased goods and services and capital goods, and 50% of our suppliers by spend covering upstream transportation and distribution and business travel, will have science-based targets (SBTs) by 2025. People and Sustainability Business Review continued 48 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report |
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The Code includes high-level Global Policies complemented by Global Standards. We also have additional global, local and functional requirements to support employees in their daily work. The Code asks employees to report possible violations and provides information on how to do so, including via the AZ Ethics helpline or website. AZ Ethics is also available to third parties. Reports can be made anonymously where desired and permitted by local law. Anyone who raises a potential breach in good faith is fully supported by management; retaliation is not tolerated. The majority of cases come to our attention through self-reporting to line managers or local Human Resources, Legal or Compliance. In 2023, 470 reports of alleged compliance breaches or other ethical concerns were made through AZ Ethics, including anonymous reports that could be considered whistleblowing (2022: 490). A Finance Code complements the Code and applies to the CFO, the Group’s principal accounting officers (including key finance staff in all overseas subsidiaries) and all managers in the Finance function. This reinforces the importance of the integrity of the Group’s Financial Statements, the reliability of the accounting records on which they are based, and the robustness of the relevant controls and processes. Ethics and transparency BV We seek to create positive societal impact and embed ethical behaviour in all our business activities, markets and value chain. We promote ethical, transparent and inclusive policies internally as well as with our partners and suppliers. It is important that we create value beyond the impact our medicines have on patients. We need to ensure that we retain and increase trust across all our stakeholder groups in order to continue delivering life-changing medicines to patients. Achievements in 2023 > 50.1% of senior middle management roles are held by women. > We have 10 countries with supplier diversity programmes outside the US. > 83% of employee survey respondents feel they can speak their mind at work. Code of Ethics We are committed to high ethical standards. Our Code of Ethics (the Code) embodies our Values, expected behaviours, principles and policies. It applies to all Executive and Non-Executive Directors, officers, employees and contract staff of our worldwide Group. The Code empowers employees to make decisions in the best interests of the Group, the communities in which we work and the people we serve. It focuses on why our commitments matter and is at the core of our Compliance Programme. It has been translated into approximately 40 languages and guides employees on how to make the best choices and act in a consistent, responsible way. Our mandatory training reminds employees of our commitments. In 2023, 100% of active employees completed annual training on the Code. Non-Financial and Sustainability Information Statement Under sections 414CA and 414CB of the Companies Act 2006, as introduced by the Companies, Partnerships and Groups (Accounts and Non-Financial Reporting) Regulations 2016, and amended by The Companies (Strategic Report) (Climate-related Financial Disclosure) Regulations 2022, AstraZeneca is required to include, in its Strategic Report, a non‑financial and sustainability statement containing certain information. As required by these sections, the Strategic Report contains our Climate-related Financial Disclosures (as defined in section 414CB(2A) – see pages 51 to 53), as well as information on the following matters, which include references to our relevant policies, due diligence processes and information on how we are performing against various measures in these areas: > Anti-bribery and anti-corruption, see page 39 > Code of Ethics, see page 49 > Access to healthcare, see page 47 > Environmental protection, see page 48 > People, see page 44 > Human rights, see page 45. In relation to the areas listed above, information on the Group’s Principal Risks is included in Risk Overview (see from page 54) and information on the non‑financial key performance indicators relevant to our business is included in Key Performance Indicators (see from page 12). A description of our business model is contained in Business Model and Life-cycle of a medicine (see from page 10). For more information, see: Our Sustainability Report on www.astrazeneca.com/ sustainability/resources.html. Our Code, Global Policies and Position Statements on our website, www.astrazeneca.com/ sustainability/resources.html. Champions of inclusion and diversity, and Workforce safety and health, on page 45. My Green Lab case study on page 37. Ethical use of AI Our Enterprise AI Governance team aims to ensure that AstraZeneca can maximise the benefits of AI technologies in a safe, responsible and ethical way. Business Review / People and Sustainability Strategic Report Corporate Governance Financial Statements Additional Information AstraZeneca Annual Report & Form 20-F Information 2023 49 |
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Assessment The EU Taxonomy (Regulation (EU) 2020/852) and associated Delegated Acts represent an evolving reporting framework. The EU Taxonomy (Taxonomy) is a classification system for sustainable economic activities. An economic activity is Taxonomy-eligible if it is described in the Taxonomy Delegated Acts. An economic activity is Taxonomy-aligned if it makes a substantial contribution to one or more of the specified environmental objectives, meets specified Do-No-Significant-Harm criteria, and is carried out in compliance with specified minimum social safeguards. In 2023, the EU adopted the new Environmental Delegated Act, which includes pharmaceutical activities. Information prepared under this disclosure is consistent with our Consolidated Financial Statements for the year ended 31 December 2023, and comparatives, prepared under the basis of preparation detailed in our Group Accounting Policies on page 152. Capital expenditure (Capex) was assessed for Taxonomy-eligibility on a project basis. Operating expenditures (Opex) were assessed for Taxonomy-eligibility based on the nature of expense. Taxonomy-alignment assessments were conducted on an activity level, based on our Global Standards and Policies. No activity was assessed as fully Taxonomy-aligned in 2023. Double-counting was avoided by reconciliation to underlying financial records. Interpretation of the EU Taxonomy is required and company-specific assumptions are required to fulfil the reporting requirements. Since no activity was assessed as fully Taxonomy-aligned, we have set out our required disclosures in a simplified format below as the prescribed table formats relating to alignment disclosures are not applicable. Revenue The Taxonomy-eligible Revenue KPI is defined as Taxonomy-eligible Revenue divided by Total Revenue, which corresponds to ‘Total Revenue’ in our Consolidated Statement of Comprehensive Income as detailed on page 148. The Group’s revenues are wholly derived from the business of pharmaceuticals, which we accordingly consider in total for Taxonomy-eligibility under the activity ‘Manufacture of medicinal products’. Consequently, our Taxonomy-eligible Revenue KPI for the year ended 31 December 2023 is 100% (2022: 0%). Last year, our business activity of pharmaceuticals was not covered by the EU Taxonomy. Capital expenditure The Taxonomy-eligible Capex KPI is defined as Taxonomy-eligible Capex divided by Total Capex. > Taxonomy-eligible Capex is capex related to assets or processes associated with Taxonomy-eligible activities. Purchase of intellectual property, marketing and distribution rights over medicinal products is considered in total for Taxonomy-eligibility under the activity ‘Manufacture of medicinal products’. > Total Capex corresponds to the total of the ‘Additions through business combinations’ and ‘Capital expenditure’ movement types as detailed in Note 7 – Property, plant and equipment (page 169), the total of the ‘Additions – separately acquired’ and ‘Additions through business combinations’ movement types as detailed in Note 8 – Leases Right-of-use assets (page 170), and the total of the ‘Additions – separately acquired’ and ‘Additions through business combinations’ movement types as detailed in Note 10 – Intangible assets (page 172). The Group’s Taxonomy-eligible Capex KPI for the year ended 31 December 2023 is 83% (2022: 14%). Operating expenditure The Taxonomy-eligible Opex KPI is defined as Taxonomy-eligible Opex divided by Taxonomy-defined Opex. > The Group’s Taxonomy-eligible Opex is expenses related to assets or processes associated with Taxonomy-eligible economic activities. R&D expenses are considered in total for Taxonomy-eligibility under the activity ‘Manufacture of medicinal products’. > The Group’s Taxonomy-defined Opex is the total of R&D expenses, and other direct non-capitalised costs that relate to building renovation measures, short-term leases, maintenance and repair, and any other direct expenditures incurred in the day-to-day servicing of assets of Property, plant and equipment. The Group’s Taxonomy-eligible Opex KPI for the year ended 31 December 2023 is 99% (2022: 2%). Taxonomy eligibility and alignment Revenue Capex Opex 2023 2022 2023 2022 2023 2022 $m % $m % $m % $m % $m % $m % Taxonomy-aligned activities No activities were assessed as Taxonomy-aligned Taxonomy-eligible but not Taxonomy-aligned 1.2 Manufacture of medicinal products 45,811 100 n/a n/a 65 n/a 96 n/a 6.5 Transport by motorbikes, passenger cars and light commercial vehicles 4 2 – – 7.1 Construction of new buildings 6 8 – – 7.2 Renovation of existing buildings 4,918 2 3,519 2 11,380 – 10,076 – 7.7 Acquisition and ownership of buildings 5 – 3 2 8.1 Data processing, hosting and related activities 1 1 – – 8.2 Computer programming, consultancy and related activities – 1 – – 50 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report EU Taxonomy Disclosure BV |
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Our commitment to climate change We support the Task Force on Climate-related Financial Disclosures (TCFD) framework. As such, we have made disclosures within the Annual Report consistent with the four TCFD recommendations, the 11 recommended disclosures and all sector guidance, and in compliance with the requirements of Listing Rule 9.8.6R(8) of the UK Financial Conduct Authority (FCA) and in compliance with sections 414CA and 414CB of the Companies Act 2006 and amended by The Companies (Strategic Report) (Climate-related Financial Disclosure) Regulations 2022. Pages 51 to 53 set out the required disclosures in more detail and explain where further information can be found – for example methodology and results – including documents outside this Annual Report. We have applied the TCFD framework since 2020, initially focusing on the most significant risks and opportunities, with plans to include medium- and low-risk areas indicated by section. All our business operations worldwide are in scope unless otherwise stated. To future-proof our business and build resilience to ensure long-term financial sustainability and the continued supply of medicines to patients, we have screened physical risks from the impacts of climate change across our operations and strategic suppliers. These risks are defined by the cost of interruption and strategic importance, and our assessment includes climate change-related hazards arising under three different scenarios by 2030, 2050 and 2100, including a worst-case scenario (SSP5-RCP 8.5). We prioritised screening results according to business criticality, to identify material sites for deep dive assessments during 2021 and 2023. We also continued to engage with strategic partners with a critical role in patient supply to understand their exposure to climate-related hazards and their resilience to climate change. For medicines, transition risks and opportunities are screened by using LCA and carbon intensity data. In 2023, we have continued to focus on pMDIs in our respiratory portfolio due to their relative high carbon intensity. We aim to launch our first next-generation pMDI from 2025 and complete the transition to a near-zero Global Warming Potential (GWP) propellant across our portfolio by 2030, as part of our Ambition Zero Carbon strategy to accelerate business decarbonisation while ensuring people can access essential medicines. Mitigation measures are often already in place to address climate-related risks and opportunities, including transition to a low-carbon economy and net-zero healthcare provision. Physical and transitional climate-related risks are included within a specific risk in the Group’s risk landscape ‘Failure to meet regulatory or ethical expectations on environmental impact, including climate change’. Climate risk summarised Risk or opportunity Time horizon Short/Mid/Long Potential impact How it is managed Physical risks Disruption to own and third-party supplier sites: > Increased extreme heat events and cooling needs impacting compliance with Good Manufacturing Practice. > Heavy rainfall causing local flooding and/or landslides. > High winds damaging structures. > Lack of a consistent high-quality water supply. Identified risks are embedded within planning of nature-based or technical mitigations, integrated into site master plans and local business continuity plans. Climate risks are mitigated through supply chain design and product-level business continuity management. Appropriate water management strategies are being established across our manufacturing sites and the broader supply chain. Transition risks and opportunities Some healthcare providers are transitioning to net-zero healthcare systems to meet their own climate targets, which may alter the demand for medicinal products based on their carbon footprint. SBTs and strategy for net-zero emissions by 2045, including transition to near-zero GWP propellant across our respiratory portfolio from 2025 to 2030. New EU Fluorinated-gas (F-gas) Regulation and per- and polyfluoroalkyl substances (PFAS) restriction proposal presented to the European Chemicals Agency (ECHA) and potential impact on our transition to next-generation, near-zero GWP propellant HFO-1234 ze(E). We believe the necessary safeguards and sufficient quota will remain available within the forthcoming EU F-gas Regulation to transition our pMDI portfolio safely to next-generation, near-zero GWP propellant by 2030. In response to the ECHA public consultation, we have recommended that HFO-1234 ze(E) should be excluded from the proposed universal ban to ensure patient access to essential life-saving pMDI medicines is maintained. Carbon pricing uncertainty over future environmental taxation and regulation. Delivery of the Ambition Zero Carbon strategy mitigates exposure to future value chain pricing and taxation. Supply/demand of renewable energy requires higher investment. Changes in geopolitics can lead to loss of access. Investment of approximately $175 million in our natural resource reduction programme since 2015, including $25.5 million in 2023, and collaborations with key partners to scale renewable energy sources and secure supply chain access. Change in raw material or sourcing costs, as well as costs related to the transition to low-carbon technologies. Ongoing engagement with strategic supply chain partners on their transition plans to a low-carbon economy and possible impacts on cost. Key Low risk Medium risk High risk Opportunity Time horizon for impact Short-term: 1-3 years Mid-term: 3-7 years Long-term: 7-25 years For more information, see: Our 2023 TCFD Statement on our website, www.astrazeneca.com/ annualreport2023. Our CDP response, based on 2023 performance on our approach to climate change, on www.cdp.net/en. Our Sustainability Report: which describes our overall approach and progress, on our website, www.astrazeneca.com/ sustainability/resources.html. The Risk Supplement on our website, www.astrazeneca.com/ annualreport2023. Our strategy and GHG emissions reduction targets and progress, from page 12, and on pages 43 and 48. AstraZeneca Annual Report & Form 20-F Information 2023 51 Strategic Report Corporate Governance Financial Statements Additional Information Task Force on Climate-related Financial Disclosures Summary Statement Task Force on Climate-related Financial Disclosures Summary Statement BV |
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TCFD framework and recommended disclosures AstraZeneca current status Links to more information on key developments Governance Describe the Board’s oversight of climate-related risks and opportunities. The Board Sustainability Committee monitors the execution of our sustainability strategy, including climate-related matters. The Board Audit Committee is responsible for overseeing sustainability-related disclosures that are linked to the Company’s Financial Statements. pages 2 to 3 pages 46, 93 and 96 page 6 Describe management’s role in assessing and managing climate-related risks and opportunities. Our CEO’s responsibilities to the Board include the development and performance of our climate strategy and related risks and opportunities. Our EVP, Global Operations, IT & Chief Sustainability Officer, is responsible for the overall sustainability strategy and its execution, including Ambition Zero Carbon and alignment of business priorities with climate risks and opportunities. The Ambition Zero Carbon Governance Group is accountable for the delivery of our Ambition Zero Carbon strategy. The TCFD Steering Group coordinates management of physical and transitional climate risks and opportunities. pages 2 to 3 page 46 pages 6 and 16 Strategy Describe the climate-related risks and opportunities the organisation has identified over the short, medium, and long term. Physical risks from climate change primarily relate to disruption or delays to manufacturing and/or distribution, including cold chain logistics, increased insurance premiums, reputational damage, and other resulting consequences – see table on page 51. Transition risks and opportunities are primarily regulatory and market changes, and/or pressure and ability to reduce product carbon footprints and decarbonise our value chain – see table on page 51. pages 5 to 10 pages 16 to 19 Describe the impact of climate-related risks and opportunities on the organisation’s businesses, strategy, and financial planning. Taking into account climate-related risks and opportunities, we are taking enterprise-wide action to reduce GHG emissions from our global operations and fleet by 98% by 2026 (from a 2015 baseline) with a $1 billion spend budgeted from 2020. We aim to halve our entire value chain footprint (Scope 3) by 2030, on a pathway to achieve a 90% reduction in emissions by 2045 (from a 2019 baseline). In 2023, we increased our investment in nature-based solutions to $400 million through AZ Forest, to mitigate our residual emissions and reach our net-zero SBTs to prepare for a low-carbon economy, and contribute to community and nature resilience with broader co-benefits. Our transition plan to net zero is disclosed in our Sustainability Report as a response to FCA requirement 2021/61 9.8.6F. pages 5 to 10 pages 16 to 21 Describe the resilience of the organisation’s strategy, taking into consideration different climate-related scenarios, including a 2°C or lower scenario. We build resilience by addressing the physical and transitional risks and opportunities across the value chain. We have used three different climate-related scenarios (RCP 2.6, 4.5 and 8.5). We are building resilience against a worst-case scenario (RCP 8.5) in our supply chain by investing in mitigation in at-risk sites, supply chain design, and inventory levels, to manage interruption risks. No material business impact from such short-term events is currently foreseen. Value chain decarbonisation, with net-zero targets aligned to a 1.5°C scenario, will secure low-carbon economy resilience and scale opportunities in progressive markets. pages 1, 4 and 6 Key TCFD Statement Annual Report Sustainability Report 52 AstraZeneca Annual Report & Form 20-F Information 2023 Strategic Report Task Force on Climate-related Financial Disclosures Summary Statement continued BV |
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TCFD framework and recommended disclosures AstraZeneca current status Links to more information on key developments Risk management Describe the organisation’s processes for identifying and assessing climate-related risks. Integrated climate assessments inform the enterprise of specific risks and opportunities posed by climate change and/or transition to a low-carbon economy. Each business area is responsible for managing identified climate risks related to its area. pages 1 to 3 and 5 to 7 pages 54, 55 and 96 pages 16 to 23 Describe the organisation’s processes for managing climate-related risks. We have screened and assessed physical risks from climate change across our operations and strategic suppliers to understand our exposure in the value chain at a product level. Identified risks are addressed in local business continuity plans or by technical mitigations in site master plans. Mid- and long-term financial planning includes required investments. To understand the financial consequences of transition to a low-carbon economy, risks and opportunities are assessed both at enterprise and product levels for examples of medicines where LCA data is available. Our Ambition Zero Carbon strategy is reducing our GHG footprint, mitigating some transition risks, and protecting revenue. pages 1 to 3 and 5 to 10 pages 48, 54, 55 and 96 pages 16 to 23 Describe how processes for identifying, assessing, and managing climate-related risks are integrated into the organisation’s overall risk management. Identified risks at corporate level are cascaded throughout the organisation. Business unit management have responsibility for risks in their area. Risks identified at local level are managed locally and escalated to functional and/ or enterprise level if significant, in line with our established enterprise risk management framework. pages 1 to 3 and 5 to 7 pages 54, 55 and 96 pages 16 to 23 Metrics and targets Disclose the metrics used by the organisation to assess climate-related risks and opportunities in line with its strategy and risk management process. Scope 1 and 2 GHG emissions are reported in line with World Resources Institute GHG Protocol guidance and disclosed in our Sustainability Report on our website, www.astrazeneca.com/sustainability/resources.html. page 11 pages 48 and 230 pages 17 to 19 and 32 to 34 Disclose Scope 1, Scope 2 and, if appropriate, Scope 3 GHG emissions and the related risks. GHG footprint and progress towards all targets are reported in line with World Resources Institute GHG Protocol guidance and disclosed in our Sustainability Report on our website, www.astrazeneca.com/sustainability/ resources.html. pages 48 and 230 pages 17 to 19 and 32 Describe the targets used by the organisation to manage climate-related risks and opportunities and performance against targets. Relevant metrics and KPIs in our Sustainability Report show progress on decarbonisation and reduced exposure to transition risks, as well as showing future opportunities. Achieve 98% absolute reduction in Scope 1 and Scope 2 GHG emissions by 2026 from a 2015 baseline. pages 1 to 2 page 48 pages 17 to 19 and 32 AstraZeneca Annual Report & Form 20-F Information 2023 53 Strategic Report Corporate Governance Financial Statements Additional Information Task Force on Climate-related Financial Disclosures Summary Statement |
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External assurance Bureau Veritas has provided independent external assurance to a limited level on the following sustainability information contained within this Annual Report: > Positively impacting people, society and the planet see page 5. > People and Sustainability, Key Performance Indicators, see page 15. > Bioethics, including Clinical trial transparency, Research use of human biological samples and genomic information, and Animals in research, see page 36. > Healthcare in low- and middle-income countries, see page 39. > Responsible sales and marketing, see page 39. > Anti-bribery and anti-corruption, see page 39. > Responsible supply chain, see page 40. > People and Sustainability, see page 43. > Human rights, see page 45. > Employee relations, see page 45. > Workforce safety and health, see page 45. > Sustainability, including Overview, Our approach to sustainability, Governance, Benchmarking and assurance, and Sustainability strategy, see page 46. > Access to healthcare, including Equitable access, Affordability and pricing, and Health system resilience, see page 47. > Environmental protection, including Ambition Zero Carbon, Product sustainability, and Natural resources, see page 48. > Ethics and transparency, including Code of Ethics, see page 49. > EU Taxonomy Disclosure, see page 50. > Task Force on Climate-related Financial Disclosures Summary Statement, see pages 51 to 53. See our full TCFD Statement on our website, www.astrazeneca.com/annualreport2023. > GHG reporting, see this page. BV Used throughout this Annual Report to denote the sustainability information listed above, which has been independently assured by Bureau Veritas. Based on the evidence provided and subject to the scope, objectives and limitations defined in the full assurance statement, nothing has come to the attention of Bureau Veritas causing them to believe that the sustainability information contained within this Annual Report is materially misstated. Bureau Veritas is a professional services company that has a long history of providing independent assurance services in environmental, health, safety, social and ethical management and disclosure. The full assurance statement, which includes Bureau Veritas’ scope of work, methodology, overall opinion, and limitations and exclusions, is available on our website, www.astrazeneca.com/ sustainability/resources.html. GHG reporting BV We have reported on all of the emission sources required under the Streamlined Energy and Carbon Reporting (SECR). These sources fall within our Consolidated Financial Statements. We do not have responsibility for any emission sources that are not included in our Consolidated Financial Statements. Global GHG emissions data for the period 1 January 2023 to 31 December 20231 Tonnes CO2e 2023 2022 2021 Emissions from: Scope 1: Combustion of fuel and operation of facilities2,5 180,898 237,703 239,468 Scope 2 (Market-based): Electricity (net of market instruments), heat, steam and cooling purchased for own use3,5 19,940 18,491 21,135 Scope 2 (Location-based): Electricity, heat, steam and cooling purchased for own use3,5 183,332 180,403 189,395 Company’s chosen intensity measurement: Scope 1 + Scope 2 (Market-based) emissions reported above normalised to million US dollar revenue 4.38 5.78 6.39 Scope 3 Total: Emissions from all 15 GHG Protocol Scope 3 Categories 6,736,878 6,167,415 5,925,850 Scope 3 intensity measurement: Scope 3 emissions from all 15 GHG Protocol Scope 3 Categories normalised to million US dollar revenue 147.06 139.06 145.41 MegaWatt hours (MWh) Total energy consumption4,5 1,511,334 1,568,815 1,667,765 1 Regular review of the data is carried out to ensure accuracy, consistency and reflect major business change. This has led to changes in data in previous years. The majority of the adjustments made are not material individually, except for (i) Scope 1: Combustion of fuel and operations facilities, (ii) Scope 2 (Location-based): Electricity, heat, steam and cooling purchased for own use, (iii) Company’s chosen intensity measurement: Scope 1 + Scope 2 (Market-based) emissions reported above normalised to million US dollar revenue, as a result of a divestment in manufacturing facility, update to using IPCC AR5 Global Warming Potentials (GWPs) from IPCC AR4 GWPs for calculating process, fugitive and solvent emissions and reporting of fuel volume in US & EUCAN to represent business activity. Additionally (iv) Total energy consumption data that has also changed. For (v) most material changes are: Scope 3 Category 1 purchased goods and services (methodology updated to exclude spend based emissions associated with royalty payments); (vi) Scope 3 Category 8 upstream leased assets (methodology updated to calculate GHG emissions in leased office space based on internal benchmark for office space energy consumption from mixed-use space); (vii) Scope 3 Category 11 use of sold products (methodology update to reflect IPCC AR5 GWPs from AR4 GWPs for calculating emissions associated with the patient use of sold inhalation products); and (viii) Scope 3 Category 12 end of life treatment of sold products (methodology updated to reflect GHG emissions accounted for in Scope 3 Category 11 use of sold products and remove double counting of GHG emissions). 2 Included in this section are GHGs from direct fuel combustion, process and engineering emissions at our sites and from fuel use in our vehicle fleet. 3 GHGs from imported electricity are calculated using the GHG Protocol Scope 2 Guidance (January 2015) requiring dual reporting using two emissions factors for each site – Market-based and Location-based. Our corporate emissions reporting and targets follow the Market-based approach. We have used the GHG Protocol Corporate Accounting and Reporting Standard (revised edition). Emission factors for electricity have been derived from the International Energy Agency, USEPA eGRID, US Green-e and the Association of Issuing Bodies databases and for all other fuels and emission sources from the 2006 IPCC Guidelines for National Greenhouse Gas Inventories. 4 The aggregate of: (i) the annual quantity of energy consumed from activities for which the Company is responsible, including the combustion of fuel at a facility or the operation of any facility; and (ii) the annual quantity of energy consumed resulting from the purchase of electricity, heat, steam or cooling by the Company for its own use. 5 Under the Companies (Directors’ Report) and Limited Liability Partnerships (Energy and Carbon Report) Regulations 2018, the Company needs to disclose what proportion of this figure relates to energy use in the UK and offshore area. For 2023, the proportion of total global energy and emissions originating from AstraZeneca’s UK and offshore area footprint were as follows: energy use 295 GWh (20%); Scope 1 site energy and road fleet emissions 28 ktCO2e (14%); Scope 2 site imported energy emissions using Market-based accounting 0 ktCO2e (0%) and Scope 2 site imported energy emissions using Location‑based accounting 17 ktCO2e (9%). In the period covered by the report AstraZeneca has installed LED lighting, upgraded chillers, improved controls for heating, ventilation and air conditioning systems, continued improvements for the combined heat and power plant, and maintained ISO 50001 certification at the Macclesfield facility, UK. At the manufacturing site in Liverpool, UK new efficient electric steam boilers have been installed. 230 AstraZeneca Annual Report & Form 20-F Information 2023 Additional Information Sustainability supplementary information For more information, see Environmental protection from page 48. For more information, see our Sustainability Report on our website, www.astrazeneca.com/ sustainability. |
Exhibit 17.1
Subsidiary Guarantors and Issuers of Guaranteed Registered Securities
Registered U.S. Bonds |
Subsidiary Issuer |
Parent Guarantor |
0.700% Notes due 2024 |
AstraZeneca Finance LLC |
AstraZeneca PLC |
1.200% Notes due 2026 |
AstraZeneca Finance LLC |
AstraZeneca PLC |
1.750% Notes due 2028 |
AstraZeneca Finance LLC |
AstraZeneca PLC |
4.875% Notes due 2028 |
AstraZeneca Finance LLC |
AstraZeneca PLC |
4.900% Notes due 2030 |
AstraZeneca Finance LLC |
AstraZeneca PLC |
2.250% Notes due 2031 |
AstraZeneca Finance LLC |
AstraZeneca PLC |
4.875% Notes due 2033 |
AstraZeneca Finance LLC |
AstraZeneca PLC |
Exhibit 97.1
ANNEX 1
US CLAWBACK POLICY
APPLICABLE TO EXECUTIVE OFFICERS (“Executive Officer Policy”)
1. |
Purpose. |
The purpose of this Executive Officer Policy is to set out the circumstances under which Executive Officers of AstraZeneca will be required to repay or return certain Excess Awarded Compensation to the Group to comply with the U.S. Clawback Rule and the U.S. Listing Rule.
2. |
Recovery of Excess Awarded Compensation. |
a) |
Recovery of Excess Awarded Compensation. If there is an Accounting Restatement, RemCo shall reasonably promptly determine the amount of any Excess Awarded Compensation for each Executive Officer in connection with such Accounting Restatement and then notify each Executive Officer in writing of the amount of Excess Awarded Compensation and a demand for repayment or return, as applicable. |
b) |
Forms of Recovery. RemCo shall determine, in its sole discretion, the method(s) for recovering any Excess Awarded Compensation, which may include: (i) cash reimbursement; (ii) recovery or forfeiture of any gain realised on the vesting, exercise, settlement, sale, transfer or other disposition of any equity-based awards; (iii) offsetting the amount from any compensation otherwise owed by AstraZeneca to the Executive Officer; and (iv) cancelling outstanding vested or unvested equity awards. Any reduction, cancellation or forfeiture of any compensation shall be done in compliance with Section 409A of the Internal Revenue Code of 1986, as amended. The Group may not accept less than the amount of Excess Awarded Compensation in satisfaction of an Executive Officer’s obligations. |
c) |
Executive Officer’s Failure to Repay. If an Executive Officer fails to repay all Excess Awarded Compensation to the Group when due, AstraZeneca shall take all actions reasonable and appropriate to recover such Excess Awarded Compensation from the Executive Officer (including suing for repayment and/or enforcing such Executive Officer’s obligation to make payment through the reduction or cancellation of outstanding and future compensation). The Executive Officer must reimburse the Group for all expenses reasonably incurred (including legal fees) by the Group in recovering such Excess Awarded Compensation. |
d) |
No Indemnification. No member of the Group may indemnify any Executive Officer against: (i) the loss of any Excess Awarded Compensation that is repaid, returned or recovered pursuant to this Executive Officer Policy; or (ii) any claims relating to the AstraZeneca’s enforcement of its rights under this Executive Officer Policy (including, for the avoidance of doubt, any advancement of costs related to such enforcement). Further, no member of the Group may enter into any agreement that exempts any Performance-Based Compensation from the application of this Executive Officer Policy or that waives AstraZeneca’s right to recovery of any Excess Awarded Compensation and this Executive Officer Policy shall supersede any such agreement (whether entered into before, on or after 1 December 2023). |
e) |
Exceptions to Recovery. Notwithstanding anything in this Executive Officer Policy to the contrary, AstraZeneca shall not be required to take the actions contemplated by Section b) or c) above if the following conditions are met and RemCo determines that recovery would be impracticable: |
i. |
The direct expenses paid to a third party to assist in enforcing the Executive Officer Policy against an Executive Officer would exceed the amount to be recovered, after AstraZeneca has made a reasonable attempt to recover the applicable Excess Awarded Compensation, and RemCo has documented such attempt(s) and provided such documentation to the U.S. Exchange; or |
ii. |
Recovery would violate the home country law of AstraZeneca, where that law was adopted prior to 28 November 2022, provided that, before determining that it would be impracticable to recover any amount of Excess Awarded Compensation based on violation of home country law, AstraZeneca has obtained an opinion of home country counsel, acceptable to the U.S. Exchange, that recovery would result in such a violation and a copy of the opinion is provided to the U.S. Exchange; or |
iii. |
Recovery would likely cause an otherwise tax-qualified retirement plan, under which benefits are broadly available to employees of any member of the Group, to fail to meet the U.S. requirements of 26 U.S.C 401(a)(13), and the regulations thereunder, or 26 U.S.C. 411(a), and the regulations thereunder. |
3. |
Amendment and Termination. |
No amendment or termination of this Executive Officer Policy shall be effective if such amendment or termination would (after taking into account any actions taken by AstraZeneca contemporaneously with such amendment or termination) cause AstraZeneca to violate any U.S. federal securities laws (including the U.S. Clawback Rule), the SEC rule or the U.S. Listing Rule.
4. |
Filing Requirements. |
AstraZeneca shall file all relevant disclosures with respect to this Executive Officer Policy in accordance with the requirements of the U.S. federal securities laws, including relevant disclosures required by SEC filings.
5. |
Non-Exclusivity. |
Any right of recoupment under this Executive Officer Policy is in addition to, and not in lieu of, any other remedies or rights of recoupment that may be available to any member of the Group under applicable law, regulation or rule or pursuant to the terms of any similar policy in any employment contract, service agreement, equity award agreement, or similar agreement and any other legal remedies available to the Group.
6. |
Successors. |
This Executive Officer Policy shall be binding and enforceable against all Executive Officers and their beneficiaries, heirs, executors, administrators or other legal representatives.
ANNEX 2
Definitions
Accounting Restatement means an accounting restatement due to the material non-compliance of AstraZeneca with any financial reporting requirement under applicable U.S. securities laws, including (i) any required accounting restatement to correct an error in previously issued financial statements of AstraZeneca that is material to the previously issued financial statements of AstraZeneca; or (ii) that corrects an error that is not material to previously issued financial statements of AstraZeneca, but would result in a material misstatement if the error were corrected in the current period or left uncorrected in the current period;
AstraZeneca means AstraZeneca PLC, registered in England and Wales under number 02723534;
Board means the board of directors of AstraZeneca or a duly authorised committee of it which may include RemCo;
Covered Period means, with respect to any Accounting Restatement, the three completed Financial Years of AstraZeneca immediately preceding the Restatement Date and any Transition Period of less than nine months within or immediately following those three completed Financial Years;
Excess Awarded Compensation means the gross amount of Performance-Based Compensation Received by a current of former Executive Officer during a Covered Period (at any time during the relevant performance period in which they were an Executive Officer) that exceeds the amount of Performance- Based Compensation that such current or former Executive Officer would have Received had it been determined based on the Accounting Restatement; provided that, for Performance-Based Compensation that is based on or related to AstraZeneca’s share price or total shareholder return where the amount of Excess Awarded Compensation is not subject to mathematical recalculation directly from information in the applicable Accounting Restatement, the amount that would have been Received shall be determined by RemCo based on a reasonable estimate of the effect of the Accounting Restatement on the share price or total shareholder return, as applicable, upon which the Performance-Based Compensation was Received (in which case, AstraZeneca shall maintain documentation of such determination of that reasonable estimate and provide such documentation to the U.S. Exchange). Notwithstanding this, compensation amounts shall only be considered “Excess Awarded Compensation” for the purposes of the Executive Officer Policy if such compensation is Received: (i) while AstraZeneca has a class of securities listed on a U.S. securities exchange or a U.S. securities association; and (ii) on or after 2 October 2023;
Executive Officer means such individuals who have been notified by AstraZeneca that they are considered to be “executive officers" for the purposes of the U.S. Clawback Rule and the U.S. Listing Rule on the basis that they are one of the following: AstraZeneca’s president, principal financial officer, principal accounting officer (or if there is no such accounting officer, the controller), any vice president of AstraZeneca in charge of a principal business unit, division, or function (such as sales, administration, or finance), any other officer who performs a policy-making function, or any other person who performs similar policy-making functions for AstraZeneca; is derived wholly or in part from such measure (in each case, regardless of whether such measure is presented within AstraZeneca’s financial statements or included in a filing with the SEC);
Executive Officer Policy means that part of AstraZeneca’s Clawback Policy which applies to Executive Officers to comply with the U.S. Clawback Rule and the U.S. Listing Rule, as amended from time to time;
Financial Reporting Measure means any measure that is determined and presented in accordance with the accounting principles used in preparing AstraZeneca’s financial statements, and any other measure that
Financial Year means the AstraZeneca’s financial year; provided that a Transition Period between the last day of AstraZeneca’s previous financial year end and the first day of its new financial year that comprises a period of nine to twelve months will be deemed a completed financial year;
Group means AstraZeneca, together with each of its direct and indirect parents and subsidiaries and member of the Group shall be construed accordingly;
Performance-Based Compensation means any compensation (whether cash or equity-based) that is granted, earned, or vested based wholly or in part upon the attainment of a Financial Reporting Measure. For the avoidance of doubt, Performance-Based Compensation does not include any compensation to the extent that it is: (i) granted, earned, or vested exclusively upon completion of a specified employment period, without any performance condition; (ii) discretionary; or (iii) based on subjective goals or goals that do not constitute Financial Reporting Measures;
Received means, with respect to Performance-Based Compensation, the date of deemed receipt, and for these purposes, Performance-Based Compensation shall be deemed Received in the Financial Year during which the applicable Financial Reporting Measure is attained, even if payment or grant of the Performance- Based Compensation occurs after the end of that period;
RemCo means the remuneration committee of the Board or the Board itself;
Restatement Date means the earlier of: (i) the date that the Board or an officer or officers of AstraZeneca authorised to take such action if Board action is not required, concludes, or reasonably should have concluded, that AstraZeneca is required to prepare an Accounting Restatement; or (ii) the date a court, regulator, or other legally authorised body directs AstraZeneca to prepare an Accounting Restatement;
SEC means the U.S. Securities and Exchange Commission;
Standard means the AstraZeneca PLC Malus and Clawback Global Standard, as may be amended from time to time;
Transition Period means any transition period that results from a change in AstraZeneca’s Financial Year within or immediately following the three completed Financial Years immediately preceding the Restatement Date;
U.S. Clawback Rule means Section 10D of the U.S. Exchange Act and the rules and regulations pursuant to it, each as may be amended from time to time;
U.S. Exchange means mean The Nasdaq Stock Market;
U.S. Exchange Act means the U.S. Securities Exchange Act of 1934, as amended; and
U.S. Listing Rule means Listing Rule 5608, as promulgated by The Nasdaq Stock Market LLC, as such rule may be amended from time to time.
