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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
(Mark One)
☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2023
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
OR
☐ 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__________
Commission file number 001-39822
Pharming Group N.V.
(Exact name of registrant as specified in its charter)
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The Netherlands |
2834 |
Not applicable |
(Jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(Translation of Registrant’s
name into English)
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Pharming Group N.V.
Darwinweg 24
2333 CR Leiden
The Netherlands
Tel: +31 (0)71 5247 400
(Address of principal executive offices)
Dr. Sijmen de Vries, CEO
+31 71 5247 400
E: investor@pharming.com
Pharming Group N.V.
Darwinweg 24
2333 CR Leiden
The Netherlands
(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.
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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 ten ordinary shares, nominal value EUR 0.01 per share
Ordinary shares, nominal value EUR 0.01 per share* |
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PHAR |
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The Nasdaq Stock Market LLC
The Nasdaq Stock Market LLC*
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Securities registered or to be registered pursuant to Section 12(g) of the Act. None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None
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.
671,073,243 ordinary shares, nominal value €0.01 per share, as of December 31, 2023.
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
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 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 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 “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Emerging growth company ☐
If an emerging growth company that prepares its financial statements in accordance with U.S. 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:
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| U.S. GAAP ☐ |
International Financial Reporting Standards as issued by the International Accounting Standards Board ☒ |
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
* listed not for trading or quotation purposes, but only in connection with the registration of American Depository Shares representing such ordinary shares pursuant to the requirements of the Securities and Exchange Commission. The American Depository Shares are registered under the Securities Act of 1933, as amended, pursuant to a separate registration statement on Form F-6 (File No. 333-251421).
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| TABLE OF CONTENTS |
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PAGE |
| Part I |
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| Item 1. |
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| Item 2. |
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| Item 3. |
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| Item 4. |
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| Item 4 A. |
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| Item 5. |
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E. CRITICAL ACCOUNTING ESTIMATES |
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| Item 6. |
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| Item 7. |
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| Item 8. |
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| Item 9. |
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| Item 10. |
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B. MEMORANDUM AND ARTICLES OF ASSOCIATION |
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| Item 11. |
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| Item 12. |
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| Part II |
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| Item 13. |
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| Item 14. |
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| Item 15. |
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| Item 16. |
[RESERVED] |
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| Item 16A. |
AUDIT COMMITTEE FINANCIAL EXPERT |
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| Item 16B. |
CODE OF ETHICS |
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| Item 16C. |
PRINCIPAL ACCOUNTANT FEES AND SERVICES |
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| Item 16D. |
EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES |
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| Item 16E. |
PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS |
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| Item 16F. |
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT |
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| Item 16G. |
CORPORATE GOVERNANCE |
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| Item 16H. |
MINE SAFETY DISCLOSURE |
124 |
| Item 16I. |
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTION |
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| Item 16J. |
INSIDER TRADING |
125 |
| Item 16K. |
CYBERSECURITY |
125 |
| Part III |
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| Item 17. |
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| Item 18. |
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| Item 19. |
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GENERAL INFORMATION
In this Annual Report on Form 20-F, or Annual Report, the terms “Pharming”, “Pharming Group”, “Pharming Group N.V.”, “the Group”, “the Company”, “we”, “us” and “our” refer to Pharming Group N.V. together with its subsidiaries, except where the context otherwise requires.
“Joenja®” is the global registered trademark for leniolisib. When discussing the U.S. market or the commercialized product in the U.S., we generally use the trademarked name Joenja® instead of leniolisib.
“leniolisib” is the term we generally use when discussing clinical trials or studies prior to U.S. approval or the product as related to markets outside of the U.S.
TRADEMARKS, TRADE NAMES AND SERVICE MARKS
We own or have rights to trademarks, service marks and trade names that we use in connection with the operation of our business, including our corporate name, logos and website names. We own the trademarks RUCONEST® and Joenja® among others, as well as the graphic trademark found on our website. There are trademarks, service marks and trade names appearing in this Annual Report that are the property of their respective owners. Solely for convenience, some of the trademarks, service marks and trade names referred to in this Annual Report are listed without the ® symbol, but we will assert, to the fullest extent under applicable law, our rights to our trademarks, service marks and trade names.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “continue” and “ongoing”, or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this Annual Report are based upon information available to us as of the date of this Annual Report and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements include, but are not limited to, statements about:
•the development of our product candidates, including statements regarding the timing of initiation, completion and the outcome of clinical trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;
•our ability to obtain and maintain regulatory approval of our product candidates in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved drug or therapy;
•our plans to collaborate, or statements regarding the ongoing collaborations, with third parties;
•our plans to research, develop, manufacture and commercialize our product candidates;
•the timing of our regulatory filings for our product candidates;
•the size and growth potential of the markets for our product candidates;
•our ability to raise additional capital;
•our commercialization, marketing and manufacturing capabilities and strategy;
•our expectations regarding our ability to obtain and maintain intellectual property protection;
•our ability to attract and retain qualified employees and key personnel;
•our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
•our estimates regarding future revenues, expenses and needs for additional financing;
•our belief that our existing cash, cash equivalents and term deposits will be sufficient to fund our operating expenses and capital expenditure requirements as we currently expect; and
•regulatory developments in the United States, The Netherlands, other European Union, or EU Member States and other jurisdictions including tax matters.
You should refer to the section of this Annual Report titled “Item 3 — D. Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.
You should read this Annual Report and the documents that we reference in this Annual Report and have filed as exhibits to this Annual Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
This Annual Report contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties such as investment banking analysts, industry, medical and general publications, government data and similar sources. Although we believe these sources are reliable, we do not guarantee the accuracy or completeness of this information and we have not independently verified this information. In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Item 3 — D. Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates.
APPLICATION OF INTERNATIONAL FINANCIAL REPORTING STANDARDS
We adopted International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. Unless otherwise stated, all information presented herein has been prepared in accordance with IFRS and all prior period amounts have been prepared in accordance with IFRS.
CURRENCY
Unless otherwise stated, “$”, when used in this Annual Report, refers to U.S. dollars and “€” refers to Euros.
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. Reasons for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
Our business faces significant risks and uncertainties. You should carefully consider all of the information set forth in this Annual Report and in other documents we file with or furnish to the Securities and Exchange Commission, or SEC, including the following risk factors, before deciding to invest in or to maintain an investment in our securities. Our business, as well as our reputation, financial condition, results of operations, and share price, could be materially adversely affected by any of these risks, as well as other risks and uncertainties not currently known to us or not currently considered material.
Summary of Selected Risks Associated with Our Business
•The development and commercialization of pharmaceuticals and biologics is highly competitive. In particular, RUCONEST® faces competition from other products (acute and prophylactic) used to treat Hereditary Angioedema, or HAE, including products to prevent and treat HAE attacks. There are several products from other competitors that have been approved in the U.S. and Europe for the treatment of HAE attacks. Consequently, we may not obtain sufficient market penetration with RUCONEST® or a sufficient level of sales of the product to remain profitable.
•We are heavily dependent on sales of RUCONEST® in the United States and Europe. If we are unable to continue to commercialize RUCONEST®, our business could be materially harmed.
•Joenja® is a newly approved drug in the U.S. and could develop unexpected safety or efficacy concerns, which would likely have a material adverse effect on us.
•The commercial success of our approved products depends, and the commercial success of any product candidate will depend, upon the degree of market acceptance by physicians, patients, payors and others in the medical community.
•If we are unable to maintain and grow our sales and marketing capabilities, particularly outside of the United States, or enter into agreements with third parties to market and sell our products outside of the United States and Europe, our business will be adversely affected.
Revenue from our approved products depends, and the successful commercialization of our product candidates will depend, in part, on the extent to which governmental authorities and health insurers maintain or establish, as applicable, adequate coverage, reimbursement levels and pricing policies. Failure to maintain or obtain coverage and adequate reimbursement for our approved products and our product candidates, if approved, could limit our ability to market those products and decrease revenue generating ability.
•Since many of our product candidates are at an early stage of development, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential than our current product candidates due to limited resources available.
•The costs and timing of potential clinical trials, filings and approvals, and the potential therapeutic scope of the development and commercialization of our products involve a high degree of uncertainty and risk which make it difficult to predict the time and costs of product development of novel approaches.
•We rely on third parties for the conduct of significant aspects of our preclinical studies and clinical trials and intend to rely on third parties in the future. If these third parties do not successfully carry out their contractual duties, our business may be adversely impacted.
•We conduct clinical trials for certain of our product candidates at sites outside the United States. The U.S. Food and Drug Administration, or the FDA, may not accept data from trials conducted in such locations.
•We may not be able to obtain or maintain orphan drug exclusivity for our products or product candidates. If our competitors are able to obtain orphan drug exclusivity for their products, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.
•The results from our clinical trials may not be sufficiently robust to support the submission of marketing approval for our product candidates. Before we submit our product candidates for marketing approval, the FDA and/or the European Medicines Agency, or the EMA, may require us to conduct additional clinical trials or evaluate patients for an additional follow-up period.
•We depend on our information technology systems and have been and may in the future be the victim of cyberattacks which compromise the privacy, security, integrity or confidentiality of sensitive information related to our business or prevent us from accessing critical information and expose us to liability and reputational harm, which could adversely affect our business, results of operations and financial condition.
•Any contamination in the manufacturing process for our recombinant products, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules and significantly impact commercially available goods.
•We are dependent on a limited number of suppliers for some of the components and materials used in our product candidates and product. Any disruption in the supply of these materials could adversely affect our ability to deliver product or complete clinical trials. Other studies of product candidates, regulatory applications or commercializing product candidates in a timely and commercially valuable manner, may be adversely affected, should supply be disrupted.
•We depend on third-party manufacturers for the production of Joenja® and for the production of rhC1INH for commercial supply and for use in clinical trials of RUCONEST®, as well as our product candidates for clinical trials. Interruption in supply could materially and adversely affect sales.
•We experience significant customer concentration, with a limited number of customers accounting for a significant portion of our revenues.
•Our success is dependent on our ability to obtain and protect rights to proprietary technology and to develop our technology and products without infringing the proprietary rights of third parties.
•Our patents may be challenged, deemed unenforceable, invalidated or circumvented, and if we do not obtain or maintain patent protection for the products, our business may be materially harmed.
•There are material weaknesses in our internal control over financial reporting and if we are unable to remediate them, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal control, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and stock price.
•Our business and operations may be negatively impacted by the failure, or perceived failure, of achieving environmental, social and governance, or ESG, objectives.
Risks Related to Our Business
The development and commercialization of pharmaceuticals and biologics is highly competitive. In particular, RUCONEST® faces intense competition from other products used to treat Hereditary Angioedema, or HAE. Several products have been approved in the U.S. and Europe for the treatment of HAE attacks. Consequently, we may not obtain sufficient market penetration with RUCONEST® or a sufficient level of sales of the product to remain profitable.
The development and commercialization of pharmaceuticals and biologics is highly competitive. In particular, RUCONEST® faces intense competition from other products used to treat HAE. We face the risk that RUCONEST® may no longer be competitive and accepted by physicians, patients, payors and others in the medical community within acute HAE market. Prophylactic therapies are increasingly used, which may result in HAE patients requiring less acute rescue medicine. RUCONEST® is not approved for prophylactic use.
Several products have been approved in the U.S. and Europe for the treatment of HAE attacks, including human blood plasma derived C1INH products. Oral products for the prevention of HAE attacks are also being developed. Orladeyo® (berotralstat) is an oral prophylactic product which was approved in the fourth quarter of 2020. In the acute market, we face pricing competition as a result of the 2019 market entry of generic equivalents to the acute treatment: Firayzr® (icatibant injection). Consequently, we may not obtain sufficient market penetration with RUCONEST® or a sufficient level of sales of the product to allow it to remain profitable. New technologies from competitors may make RUCONEST® obsolete.
Our competitors include major international pharmaceutical companies as well as smaller or regional specialty pharmaceutical and biotechnology companies. Many of our competitors are larger and have greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, prosecuting intellectual property rights and marketing approved products than we do.
Such competitors may be better equipped to withstand changes in economic and industry conditions. Smaller or early stage companies may also be significant competitors, particularly through collaborative arrangements with large, established companies. Key competitive factors affecting the commercial success of our products and any other products that we develop or acquire are likely to be safety, efficacy, tolerability profile, reliability, convenience of dosing, price and reimbursement. We may also face future competition from companies selling generic alternatives to RUCONEST® in countries where we do not have patent coverage, orphan drug status or another form of data or marketing exclusivity or where patent coverage or data or marketing exclusivity has expired, is not enforced, or may, in the future, be challenged.
We are heavily dependent on sales of RUCONEST® in the United States and Europe. If we are unable to continue to commercialize RUCONEST®, our business could be materially harmed.
We have, to date, been substantially focused on the development and commercialization of RUCONEST®, and we expect to continue to be dependent primarily on revenues from RUCONEST® sales in the near term. Although we have begun sales of Joenja® in the United States, RUCONEST® sales accounted for approximately 92.6% of our total revenues in 2023, and we expect it to continue to make up the majority of our revenues for the foreseeable future. Accordingly, any adverse events or findings regarding the properties, efficacy or safety of RUCONEST®, or material constraints on the manufacturing of RUCONEST®, may have a material impact on our financial results and operations.
Our ability to meet expectations with respect to sales of RUCONEST®, generate revenues from such sales, and attain and maintain positive cash flow from operations, in the time periods anticipated, or at all, will depend on a number of factors, including, among others:
•the ability to continue to maintain and grow market acceptance for RUCONEST® among healthcare professionals and patients in the United States, EU, and other key markets for the treatment of approved indications;
•our ability to maintain regulatory approvals without onerous restrictions or limitations in key markets;
•our ability to secure regulatory approvals in additional markets on a timely basis and with commercially feasible labels;
•our ability to obtain pricing and reimbursement approvals at adequate levels, where required, on a timely basis;
•presence of side effects or other safety issues associated with the use of RUCONEST® that could require us or our distributors to modify or halt commercialization;
•whether we will be required by regulatory agencies to conduct additional studies regarding the safety and efficacy of RUCONEST®, which we have not planned or anticipated;
•increased competition from competitors;
•obtaining and maintaining commercial distribution agreements with third-party distributors outside the United States and Europe;
•obtaining and maintaining patent protection and regulatory exclusivity; and adequately investing in the manufacturing, sales, marketing, market access, medical affairs and other functions that are supportive of our commercialization efforts.
Joenja® is a newly approved drug in the U.S. and could develop unexpected safety or efficacy concerns, which would likely have a material adverse effect on us.
Joenja® was granted approval by the FDA in late March 2023. In the United States, Joenja® will now be used by larger numbers of patients, potentially for longer periods of time, and we and others (including regulatory agencies and private payors) will collect extensive information on the efficacy and safety of Joenja® by monitoring its use in the marketplace. New safety or efficacy data from market surveillance may result in negative consequences including the following:
•Modification to product labeling or promotional statements, such as additional boxed or other warnings or contraindications, or the issuance of additional “Dear Doctor Letters” or similar communications to healthcare professionals;
•Required changes in the administration of Joenja®;
•Imposition of additional post-marketing surveillance, post-marketing clinical trial requirements, distribution restrictions or other risk management measures, such as a risk evaluation and mitigation strategy;
•Suspension or withdrawal of regulatory approval or delays or declination of regulatory approval outside of the United States;
•Suspension of, or imposition of restrictions on, our operations, including costly new manufacturing requirements with respect to Joenja®; and
•Voluntary or mandatory product recalls or withdrawals from the market and costly product liability claims.
Any of these circumstances could reduce Joenja’s® market acceptance and would be likely to materially adversely affect our business.
The commercial success of our approved products depends, and the commercial success of any product candidate will depend, upon the degree of market acceptance by physicians, patients, payors and others in the medical community.
The commercial success of our approved products depends, and of our product candidates will depend, in part, on the medical community, patients, and payors accepting them as effective, safe and cost-effective. If our product candidates do not achieve an adequate level of acceptance, we may struggle to continue to generate significant product revenues and may not in the future generate any profits from operations. The degree of market acceptance of our approved products, in particular Joenja®, or our product candidates, if approved for commercial sale, will depend on a number of factors, including:
•the potential efficacy and potential advantages over alternative treatments;
•the frequency and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling;
•the frequency and severity of any side effects resulting from the conditioning regimen or follow-up requirements for the administration of our product candidates;
•the relative convenience and ease of administration;
•the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
•the strength of marketing and distribution support and timing of market introduction of competitive products;
•publicity concerning our products or competing products and treatments;
•continued demand from two U.S. specialty wholesale companies that in 2023 represented 83% of our revenues; and
•sufficient third-party insurance coverage or reimbursement.
Even if a product candidate displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product, if approved for commercial sale, will not be known until after it is launched. Our efforts to educate the medical community and payors on the benefits of our products, particularly Joenja® given its recent approval, and product candidates may require significant resources and may never be successful. Such efforts to educate the marketplace may require more resources than are required by the conventional technologies marketed by our competitors.
If we are unable to maintain and grow our sales and marketing capabilities, particularly outside of the United States, or enter into agreements with third parties to market and sell our products outside of the United States and Europe, our business will be adversely affected.
We have been promoting RUCONEST® in Europe and the Middle East since we re-acquired the license in 2020 and are currently preparing for the launch of leniolisib in Europe, the U.K., the Middle East, Africa, and Asia-Pacific. Establishing and maintaining internal medical and commercial capabilities, as we are doing for Joenja®, carries an element of risk. For example, recruiting and training an integrated medical and commercial organization can be expensive and time consuming and could delay any product launch. Furthermore, if the commercialization of a product is delayed, , establishing a commercial organization prematurely would result in the need to reconfigure the organization.
Factors that may inhibit our efforts to commercialize our products on our own include:
•the inability to recruit, train and retain adequate numbers of effective medical, access, sales and marketing personnel;
•inability to obtain appropriate regulatory approval and subsequent reimbursement coverage
•the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future product that we may develop;
•the lack of complementary treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
•unforeseen costs and expenses associated with creating an independent sales and marketing organization.
We enter into arrangements with a variety of third-parties to perform a range of activities including medical affairs, regulatory and reimbursement support and, sales, marketing and distribution services outside of the United States and Europe. We have made leniolisib available for APDS patients in select key markets in Europe, the U.K., Japan, Asia-Pacific, the Middle East, and Canada. Where viable, following regulatory approval, we intend to market leniolisib directly in a number of these markets. Prior to regulatory approval in certain markets, we will make leniolisib available via a variety of access schemes. In addition, we have granted the China State Institute of Pharmaceutical Industry, or the CSIPI, an exclusive license to commercialize RUCONEST® in China, and the CSIPI is collaborating with the Chengdu Institute of Biological Products Co, Ltd, or the CDIBP,and we are solely dependent on their efforts to commercialize RUCONEST® in that territory. On December 15, 2023, the CDIBP announced that it received clinical trial approval from the Center for Drug Evaluation of the National Medical Product Administration for the clinical development of rhC1INH in China. We may receive certain regulatory and manufacturing-associated milestones, and we are eligible to receive low to mid-single digit royalties from sales in China by the CSIPI, affiliates of the CSIPI and sublicencees of the CSIPI. Dependence on distribution arrangements to commercialize our products in certain jurisdictions subjects us to a number of risks. We do not have control over such third parties and any of them may fail to devote the necessary resources and attention to distribute our products effectively. In addition, any potential non-compliance with applicable laws and regulations by such third parties would potentially expose us to sanctions. If such third-party arrangements are terminated or allowed to expire, the marketing and sales of a product in that jurisdiction may be interrupted, which could adversely affect our revenues. In addition, we may not be successful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that are favorable to us. See “Item 3 – D. Risk Factors – We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic markets. We can face criminal liability and other serious consequences for violations, which can harm our business” of this Annual Report.
Revenue from our approved products depends, and the successful commercialization of our product candidates will depend, in part, on the extent to which governmental authorities and health insurers maintain or establish, as applicable, adequate coverage, reimbursement levels and pricing policies. Failure to maintain or obtain coverage and adequate reimbursement for our approved products and our product candidates, if approved, could limit our ability to market those products and decrease revenue generating ability.
The availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors is essential for many patients to be able to afford prescription medications such as RUCONEST® and Joenja® and potential product candidates, assuming regulatory approval is obtained. Our ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations fundamentally impacts the potential success of RUCONEST® and Joenja® and potential product candidates. Assuming we obtain coverage for our product candidates by third-party payors, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the United States, the EU Member States, or elsewhere will be maintained for our approved products or available for our product candidates or any product that we may develop, and any reimbursement that may be or become available may be decreased or eliminated in the future. There is an increasing tendency of health insurers to reduce healthcare costs by limiting both the coverage and breadth of reimbursement for new therapeutic products and in some cases by refusing to provide coverage altogether.
Because coverage and reimbursement determinations are made on a payor-by-payor basis, obtaining coverage and adequate reimbursement from a third-party payor does not guarantee that we will obtain similar coverage or reimbursement from another third-party payor. Reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any products for which we obtain marketing approval. Failure to secure or retain adequate coverage or reimbursement for our products by third-party payors, or delays in processing approvals by those payors, could result in the loss of sales, loss of customers, or reputational damage, which could have a material adverse effect on our business, financial condition and operating profit.
Further, it is possible that a third-party payor may consider our product candidates as similar to alternative treatment options and only offer to reimburse patients for a less expensive product. In some cases this can involve a requirement that patients try the less expensive product first, only approving other therapies after the patient does poorly on the less expensive product. Even if we show improved efficacy or convenience of administration with our product candidates compared to products marketed by our competitors and the prevailing standard of care, the pricing of existing therapies may still limit the amount we could charge. Third-party payors may deny or revoke the reimbursement status of any given product or establish new prices for existing marketed products that inhibit us from realizing an appropriate return on our investment in the product candidates. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our product candidates, and may not be able to obtain a satisfactory financial return on them.
Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe, Canada, and other countries has and will continue to put pressure on the pricing and usage of our products. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to set their own prices for medical products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits.
Since many of our product candidates are at an early stage of development, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential than our product candidates due to limited resources available.
Other than Joenja®, which was approved by the FDA on March 24, 2023, our product pipeline candidates are all in the early stages of clinical and preclinical development. For example, our gene therapy product candidate is in preclinical development. Our spending on current and future research and development programs may not yield any commercially viable product candidates. If we do not accurately evaluate the commercial potential for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaborations, licensing or other arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. If any of these events occur, we may be forced to abandon our development efforts with respect to a particular product candidate or fail to develop a potentially successful product candidate.
The costs and timing of potential clinical trials, filings and approvals, and the potential therapeutic scope of the development and commercialization of our products involve a high degree of uncertainty and risk which make it difficult to predict the time and costs of product development of novel approaches.
New product development and indication expansions of existing products is very expensive and involves a high degree of uncertainty and risk. Only a small number of research and development programs result in the commercialization of a new product. Furthermore, the development of novel approaches for the treatment of diseases, including development efforts in new and innovative modalities present additional challenges and risks. Clinical trial data and results are subject to differing interpretations by regulatory authorities. We may view data as sufficient to support the safety, effectiveness, or approval of an investigational therapy, while regulatory authorities may disagree and may require additional data, may limit the scope of an approval or may deny approval altogether.
There can be difficulty in predicting the time and cost of product development of novel approaches for the treatment of diseases across regulatory approval authorities.
Success in preclinical work or early-stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. The results of clinical trials may indicate that our product candidates lack efficacy, have harmful side effects, result in unexpected adverse events or raise other concerns that may significantly reduce the likelihood of regulatory approval. This may result in terminated programs, significant restrictions on use and safety warnings in an approved label, adverse placement within the treatment paradigm or significant reduction in the commercial potential of the product candidate.
Even if we could successfully develop new products or indications, we may make a strategic decision to discontinue development of a product candidate or indication if, for example, we believe commercialization will be difficult relative to the standard of care or other opportunities in our pipeline.
We rely on third parties for the conduct of significant aspects of our preclinical studies and clinical trials and intend to rely on third parties in the future. If these third parties do not successfully carry out their contractual duties, our business may be adversely impacted.
We rely on third parties for the conduct of significant aspects of our preclinical studies and clinical trials. These third parties include contract research organizations, or CROs, medical institutions, clinical investigators and contract laboratories. Although we design the clinical trials for our product candidates, we depend on these third parties for aspects of performing the trials. Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our regulatory or contractual responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial.
The third parties we rely upon may fail to successfully carry out their contractual duties or meet expected deadlines, which may cause delays in the conduct of our preclinical and clinical studies.
If the CROs do not perform preclinical studies and clinical trials in a satisfactory manner, breach their obligations to us or fail to comply with regulatory requirements and other compliance obligations, the development, regulatory approval and commercialization of our product candidates may be delayed, we may not be able to obtain regulatory approval and commercialize our product candidates, or our development programs may be materially and irreversibly harmed. If we are unable to rely on preclinical and clinical data collected by our CROs, we could be required to repeat, extend the duration of, or increase the size of any clinical trials we conduct and this could significantly delay commercialization and require significantly greater expenditures. See “Item 3 – D. Risk Factors – We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic markets. We can face criminal liability and other serious consequences for violations, which can harm our business” of this Annual Report.
We conduct clinical trials for certain of our product candidates at sites outside the United States. The FDA may not accept data from trials conducted in such locations.
We and the investigators conducting clinical trials for certain of our product candidates study our product candidates outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of these data is subject to conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles. The trial population must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful.
In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will depend on its determination that the trials also complied with all applicable U.S. laws and regulations. If the FDA does not accept the data from any trial that we conduct outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and would delay or permanently halt our development of the applicable product candidates or indications. In addition, in order to commence a clinical trial in the United States, we are required to seek FDA acceptance of an Investigational New Drug application, or IND, for each of our product candidates. We cannot be certain that any IND we submit to the FDA, or any similar Clinical Trial Application, or CTA, we submit in other countries, will be accepted.
We may also be required to conduct additional preclinical testing prior to submitting an IND for any of our product candidates, and the results of any such testing may not be positive. Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to a New Drug Application, or NDA, or Biologics License Application, or BLA, submission and approval of our product candidates. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in commercializing our product candidates.
We may not be able to obtain or maintain orphan drug exclusivity for our products or product candidates. If our competitors are able to obtain orphan drug exclusivity for their products, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.
Regulatory authorities in some jurisdictions, including the United States, the EU and the United Kingdom, may designate drugs for relatively small patient populations as orphan drugs. We obtained orphan drug designation for RUCONEST® from the FDA for the treatment of acute HAE attacks. Joenja® has also received this designation from the FDA and the EMA. However, no assurances can be made for our product candidates.
Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of market exclusivity, which, subject to certain exceptions, precludes the acceptance or approval by a regulatory authority in the EU of another marketing application for a similar medicinal product or the approval by the FDA of another marketing application for the same drug for the same indication for that time period. The FDA defines “same drug” as a drug or biologic that contains the same active moiety and is intended for the same use. The applicable market exclusivity period for orphan drugs is ten years in the EU and the United Kingdom and seven years in the United States. The EU and United Kingdom exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation.
In the EU and the United Kingdom, a “similar medicinal product” is a medicinal product containing a similar active substance or substances as contained in a currently authorized orphan medicinal product, and which is intended for the same therapeutic indication. A “similar active substance” is “an identical active substance, or an active substance with the same principal molecular structural features (but not necessarily all of the same molecular structural features) and which acts via the same mechanism. However, in the case of advanced therapy medicinal products, for which the principal molecular structural features cannot be fully defined, the similarity between two active substances shall be assessed on the basis of the biological and functional characteristics.” Obtaining orphan drug exclusivity for our product candidates is important to the product candidate’s success. If a competitor obtains orphan drug exclusivity for, and approval of, a product with the same indications as our product candidates before we do and if the competitor’s product is the same drug or a similar medicinal product as ours, we could be excluded from the market for a certain period of time. If another product has obtained a marketing authorization for the same indication, we would have to prepare a similarity report (addressing the possible similarity between the authorized product and our product), which will take additional time.
Although we have obtained orphan drug exclusivity for Joenja® from the FDA, the EMA, and the Ministry of Health, Labour and Welfare of Japan, or MHLW, we may not be able to maintain it. For example, if a competitive product that is the same drug or a similar medicinal product as our product or product candidate is shown to be clinically superior to our product or product candidate, as applicable, any orphan drug exclusivity we have obtained will not block the approval of such competitive product. In addition, orphan drug exclusivity will not prevent the approval of a product that is the same drug as our product or product candidate if the FDA, EMA or United Kingdom’s Medicines and Healthcare products Regulatory Agency, or MHRA, finds that we cannot assure the availability of sufficient quantities of the drug to meet the needs of the persons with the disease or condition for which the drug was designated in the relevant jurisdiction.
The FDA Reauthorization Act of 2017 authorizes the FDA to impose additional clinical trial requirements on manufacturers seeking orphan drug designation and/or pediatric indications. Additionally, it should be noted that the European Commission is currently reviewing the EU general pharmaceutical legislation. While any revisions to the legislation will not be applicable for a number of years, the European Commission intends to make changes to the rules on orphan medicinal products including potentially reducing the duration of data and market exclusivity available.
The results from our clinical trials may not be sufficiently robust to support the submission of marketing approval for our product candidates. Before we submit our product candidates for marketing approval, the FDA, the EMA, or any other regulatory body may require us to conduct additional clinical trials or evaluate patients for an additional follow-up period.
The results from our clinical trials may not be sufficiently robust to support the submission for marketing approval for our product candidates. The FDA normally requires two registrational trials to approve a drug or biologic product, and thus the FDA may require that we conduct additional clinical trials of our product candidates prior to a BLA or NDA submission. The FDA typically does not consider a single clinical trial to be adequate to serve as a registrational trial unless among other things, it is well-controlled and demonstrates a clinically meaningful effect on mortality, irreversible morbidity, or prevention of a disease with potentially serious outcome, and a confirmatory study would be practically or ethically impossible. Additionally, while the FDA recognizes the potential for natural history models to augment the need for placebo arms in trials for drugs that target very rare disease, where trial recruitment can be especially challenging, the FDA has found the use of natural history data as a historical comparator to be unsuitable for adequate and well-controlled trials in many circumstances. The FDA generally finds trials using historical controls to be credible only when the observed effect is large in comparison to variability in disease course. Like the FDA, the EMA and MHRA also expect applicants to submit sufficient clinical data, which is usually generated from clinical studies, to demonstrate the safety and efficacy of the medicinal product.
Due to the nature of the indications our product candidates are designed to treat, and the limited number of patients with these conditions, a placebo-controlled and blinded study may not be practicable for ethical and other reasons. It is possible the FDA, EMA and/or MHRA will not consider our comparisons to natural history data and, where available, historical transplant data, to provide clinically meaningful results. Additionally, even though a product candidate may have achieved the primary endpoints in a registrational clinical trial, it is possible that the FDA, EMA and/or MHRA may require us to conduct additional registrational trials, possibly involving a larger sample size or a different clinical trial design, especially if the FDA, EMA and/or MHRA do not find the results from these trials to be sufficiently persuasive to support a BLA/NDA or Marketing Authorization Application, or MAA, submission, as applicable. The FDA, EMA and/or MHRA may also require that we conduct a longer follow-up period of post-market surveillance of patients treated with our product candidates prior to accepting our BLA/NDA or MAA submission, as applicable.
In addition, data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. There can be no assurance that the FDA, EMA or other regulatory bodies will find the efficacy endpoints in our registrational trials or any efficacy endpoint we propose in future registrational trials to be sufficiently validated and clinically meaningful, or that our product candidates will achieve the pre-specified endpoints in current or future registrational trials to a degree of statistical significance, and with acceptable safety profiles. We also may experience regulatory delays or rejections as a result of many factors, including serious adverse events involving our product candidates, changes in regulatory policy or changes in requirements during the period of our product candidate development. Any such delays could materially and adversely affect our business, financial condition, results of operations and prospects.
We expect that the FDA, EMA and/or MHRA will assess the totality of the safety and efficacy data from our product candidates in reviewing any future BLA, NDA, or MAA, submissions. Based on this assessment, the FDA, EMA and/or MHRA may require that we conduct additional preclinical studies or clinical trials prior to submitting or approving a BLA, NDA, or MAA, for our target indications.
If the FDA, EMA and/or MHRA requires additional trials, we would incur increased costs and delays in the marketing approval process, which may require us to expend more resources than we have available. In addition, it is possible that the FDA, EMA and/or MHRA may have divergent opinions on the elements necessary for a successful BLA/NDA and MAA, respectively, which may cause us to alter our development, regulatory and/or commercialization strategies.
Any future acquisitions we make may expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies.
As a part of our growth strategy, we may make additional acquisitions of complementary businesses, products or research. Any future acquisition will involve numerous risks and operational, financial and managerial challenges, including the following, any of which could adversely affect our business, financial condition or results of operations:
•limited support and user knowledge for legacy systems of acquired companies;
•problems maintaining uniform procedures, controls and policies with respect to our financial accounting systems;
•difficulties in managing geographically dispersed operations, including risks associated with entering foreign markets in which we have no or limited prior experience;
•underperformance of any acquired technology, product or business relative to our expectations and the price we paid;
•negative near-term impacts on financial results after an acquisition, including acquisition-related earnings charges;
•the potential loss of key employees, customers and strategic partners of acquired companies;
•claims by terminated employees and shareholders of acquired companies or other third parties related to the transaction;
•the assumption or incurrence of additional debt obligations or expenses, or use of substantial portions of our cash;
•the issuance of equity securities to finance or as consideration for any acquisitions that dilute the ownership of our shareholders;
•any collaboration, strategic alliance and licensing arrangement may require us to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us;
•risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals;
•diversion of management’s attention and company resources from existing operations of the business;
•inconsistencies in standards, controls, procedures and policies;
•the impairment of intangible assets as a result of technological advancements, or worse-than-expected performance of acquired companies;
•assumption of, or exposure to, historical liabilities of the acquired business, including unknown contingent or similar liabilities that are difficult to identify or accurately quantify;
•our inability to generate revenues from acquired technology or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs; and
•risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property.
There can be no assurance that any of the acquisitions we may make will be successful or will be, or will remain, profitable. Our failure to successfully address the foregoing risks may prevent us from achieving the anticipated benefits from any acquisition in a reasonable time frame, or at all.
Negative public opinion and increased regulatory scrutiny of transgenic manufacturing techniques, or activism regarding the ethical treatment of livestock, may damage public perception of RUCONEST® and our product candidates, which may adversely affect sales of our products and our ability to obtain marketing approvals for our product candidates.
Public perception may be influenced by negative public statements regarding our transgenic manufacturing technology. Our transgenic manufacturing technology platform involves the genetic engineering of animals for the production of recombinant proteins. Genetic modification of food and livestock are a common subject of debate and negative publicity. In addition, animal rights activists commonly engage in campaigns to reduce or eliminate the use of animals in the commercialization of pharmaceutical products.
Negative publicity regarding genetic modification in general, and our transgenic manufacturing techniques in particular, or activism regarding the treatment of our livestock could result in reduced market acceptance for our products, increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our potential product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.
If any such adverse events occur, commercialization of RUCONEST® or further advancement of our clinical trials could be halted or delayed, which would have a material adverse effect on our business and operations.
Our assumptions and estimates regarding prevalence and the addressable markets for our products and product candidates may be inaccurate, which could have a material adverse effect on our revenues and cash position.
If there are fewer actual patients than estimated, or if any product approval is based on narrower definitions of patient populations, our revenues and cash position could be materially and adversely affected. The patient population for the diseases that our products treat is very small, and networking, data gathering and support channels are not as established as those for more prevalent and researched disease indications. There are limited patient registries and other methods of establishing with precision the actual number of patients of our existing and potential future indications in any geography. Estimating the prevalence of a rare disease is difficult and we therefore must rely on assumptions, beliefs and an amalgam of information from multiple sources, resulting in potential under or over-reporting. There is no guarantee that our assumptions and beliefs are correct, or that the methodologies used and data collected have generated or will continue to generate accurate estimates. There is therefore uncertainty around the estimated total potential addressable patient population for treatment with RUCONEST® and Joenja® worldwide. In addition, the potential market opportunity for our product candidates that we may develop is difficult to estimate precisely, particularly given that the orphan drug markets which are targeted are, by their nature, relatively unknown. Our estimates of the potential market opportunity for each of these product candidates are predicated on several key assumptions, such as industry knowledge and publications, third-party research reports and other surveys. If any of our assumptions prove to be inaccurate, then the actual market for RUCONEST®, Joenja®, or our product candidates, could be smaller than our estimates of the potential market opportunity. If that turns out to be the case, our product revenue may be limited, and we may be unable to achieve or maintain profitability, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
We depend on our information technology systems have been and may in the future be the victim of cyberattacks, which compromise the privacy, security, integrity or confidentiality of sensitive information related to our business or prevent us from accessing critical information and expose us to liability and reputational harm, which could adversely affect our business, results of operations and financial condition.
We collect and maintain data and information that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business, including systems infrastructure operated and maintained by our third-party suppliers or providers. In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. It is critical that we do so in a secure manner to maintain the privacy, security, confidentiality and integrity of such confidential information. We have established physical, electronic and organizational measures to safeguard and secure our systems and facilities to prevent an information compromise, and rely on commercially available systems, software, tools and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. We have also outsourced elements of our information technology infrastructure, and as a result, a number of third-party vendors may or could have access to our confidential information. Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage or unauthorized access or use resulting from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, denial-of-service attacks, cyber-attacks or cyber-intrusions over the Internet, hacking, phishing and other social engineering attacks, attachments to emails, persons inside our organization (including employees or contractors), lost or stolen devices, or persons with access to systems inside our organization. We have been, and may in the future be, subject to cyberattacks.
A breach may require notification to governmental agencies, supervisory bodies, credit reporting agencies, the media or individuals pursuant to various federal, state and foreign data protection, privacy and security laws, regulations and guidelines, if applicable. These may include state breach notification laws, and the General Data Protection Regulation, or GDPR. Accordingly, a data security breach or privacy violation that leads to unauthorized access to, disclosure or modification of personal information (including protected health information), that prevents access to personal information or materially compromises the privacy, security, or confidentiality of the personal information, could result in fines, increased costs or loss of revenue and we could incur liability, our competitive position could be harmed and the further development and commercialization of our product candidates could be delayed.
Furthermore, federal, state and international laws and regulations, such as the GDPR, can expose us to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties and significant legal liability, if our information technology security efforts fail.
We rely on third parties for all quality control procedures.
The release of finished product to the market is dependent on the satisfaction of a set of quality control procedures. Some of these procedures, although validated, are very sensitive and complex (specifically for the protein platform). While ensuring and maintaining Good Manufacturing Practice, or GMP, activities at our partnered contract manufacturing organization, or CMO, sites we do not have our own GMP certified analytical laboratory capable of performing the quality control procedures needed for the release of product, and we rely on third parties for this task. We have started a program to challenge and reassess all currently used quality control procedures with the aim to improve or replace those by more robust, and easier to perform analyses and where possible create a more robust external partnership management process.
Any contamination in the manufacturing process for our recombinant products, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules and significantly impact commercially available goods.
We use living mammals as the source for our recombinant proteins. Our transgenic manufacturing platform bears the risk of failure due to contamination of the produced milk, diseases of the producing livestock, or a breakdown of the facilities. Any contamination could adversely affect our ability to produce, release, or administer our recombinant products on schedule and could, therefore, harm our results of operations and cause reputational damage. Additionally, although our recombinant products are tested for contamination prior to release, if a contaminated product was administered to a patient, it could result in harm to the patient. A raw material shortage, contamination, recall or restriction on the goods we use in the manufacture of our products could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which could adversely affect our clinical development timelines and availability of finished goods for commercial use, impacting patient access, our business, financial condition, results of operations, and prospects.
We are dependent on a limited number of suppliers for some of our components and materials used in our product candidates and products. Any disruption in the supply of these materials could adversely affect our ability to deliver product or complete clinical trials. Other studies of product candidates, regulatory applications or commercializing product candidates in a timely and commercially valuable manner, may be adversely affected, should supply be disrupted.
We rely on a limited number of suppliers for certain essential materials incorporated into, or used in the manufacture of, products and product candidates. Since RUCONEST® is authorized for use in rare and ultra-rare diseases, it might be difficult to find suppliers that can or are willing to handle small-scale quantities, which may also limit our negotiation power with these suppliers.
Many component suppliers are based in Europe, while a significant percentage of RUCONEST® sales are conducted in the U.S. If international shipping is disrupted, we may not be able to supply sufficient quantities of RUCONEST® for sale in the U.S. Any disruption in the supply of these materials could adversely affect our ability to deliver product or complete clinical trials. In addition, studies of product candidates, regulatory applications and our ability to commercialize product candidates in a timely and commercially valuable manner, may be adversely affected, should supply be disrupted.
We cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purpose. Our use of a limited number of suppliers of raw materials, components and finished goods exposes us to several risks, including disruptions in supply, price increases, late deliveries and an inability to meet customer demand. There are, in general, relatively few alternative sources of supply for these components. These vendors may be unable or unwilling to meet our future demands for our clinical trials or commercial sale. Establishing additional or replacement suppliers for these components could take a substantial amount of time and it may be difficult to establish replacement suppliers who meet regulatory requirements.
Any disruption in supply from any supplier or manufacturing location could lead to supply delays or interruptions which would damage our business, financial condition, results of operations and prospects.
If we are required to switch to a replacement supplier, the manufacture and delivery of our product and product candidates could be interrupted for an extended period, adversely affecting our business. Establishing additional or replacement suppliers may not be accomplished quickly. If we are able to find a replacement supplier, the replacement supplier would need to be qualified and may require additional regulatory authority approval, which could result in further delay. For example, the FDA or EMA could require additional supplemental data, manufacturing data and comparability data if we rely upon a new supplier. While we seek to maintain adequate inventory of the components and materials used in our product candidates, any interruption or delay in the supply of components or materials, or our inability to obtain components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to conduct our clinical trials and, if our product candidates are approved, to meet the demand of our customers and cause them to cancel orders.
In addition, as part of the FDA’s approval of our product candidates, the FDA must review and approve the individual components of our production process, which includes raw materials, the manufacturing processes and facilities of our suppliers. Our reliance on these suppliers subjects us to a number of risks that could harm our reputation, business, and financial condition, including, among other things:
•the interruption of supply resulting from modifications to or discontinuation of a supplier’s operations;
•delays in product shipments resulting from defects, reliability issues, or a supplier’s variation in a component;
•a lack of long-term supply arrangements for key components with our suppliers;
•the inability to obtain adequate supply in a timely manner, or to obtain adequate supply on commercially reasonable terms;
•difficulty and cost associated with locating and qualifying alternative suppliers for our components in a timely manner;
•production delays related to the evaluation and testing of products from alternative suppliers, and corresponding regulatory qualifications;
•a delay in delivery due to our suppliers prioritizing other customer orders over ours;
•damage to our reputation caused by defective components produced by our suppliers; and
•fluctuation in delivery by our suppliers due to changes in demand from us or their other customers.
If any of these risks materialize, costs could significantly increase and our ability to conduct our clinical trials and meet demand for our products could be impacted.
We depend on third-party manufacturers for the production of Joenja® and for the production of rhC1INH for commercial supply and for use in clinical trials of RUCONEST®, as well as our product candidates for clinical trials. Interruption in supply could materially and adversely affect sales.
We have entered into (downstream) manufacturing and supply agreements for Joenja® and RUCONEST® with, among others, Sanofi S.A., or Sanofi, and BioConnection Investments B.V. (formerly BioConnection B.V.), or BioConnection, since we do not have a GMP-certified lab capable of performing the quality control procedures necessary for the release of product. A failure of these suppliers to supply our needs would be difficult to overcome as contracting additional manufacturing capacity on a timely basis could be difficult or impossible and have significant adverse effect on our business.
We experience significant customer concentration, with a limited number of customers accounting for a significant portion of our revenues.
Two U.S. customers (namely specialty pharmacies) accounted for $204.3 million, or 83%, of our revenues for the year ended December 31, 2023 and $173.6 million, or 84%, of our revenues for the year ended December 31, 2022. Inherent risks exist when a large percentage of total revenues is concentrated with a limited number of specialty pharmacies. With specialty products, the pharmacies provide patient support services that are more than are provided by retail pharmacies, and effective communication and relations between our hub and these pharmacies are important in maintaining timely and consistent filling of prescriptions for RUCONEST®.
It is not possible for us to predict the future level of demand for our products that will be handled by these specialty pharmacies or the level of service they will provide to patients and healthcare practitioners. In addition, revenues from these large customers may fluctuate from time to time based on market demand for our products among prescribing physicians, patients and payors, the level which may be affected by market conditions or other factors, some of which may be outside of our control. Further, our contracts with these large specialty pharmacies do not contain purchase commitments or otherwise obligate them to buy a minimum or fixed volume of products from us (and allow these specialty pharmacies to return product to us for a variety of reasons). If either of our major customers experience declining or delayed sales of our products to consumers due to market, economic or competitive conditions, we could be pressured to reduce the prices we charge for our products, reduce the volume of products we supply to such customers, we could lose the customer or have a substantial amount of product returned to us. Additionally, although historically, our reserves for doubtful accounts have not been material, if either of our large customers were to suffer financial instability, they could refuse or delay payment of outstanding receivables. Any such development may have a material adverse effect on our business, results of operations and financial condition.
Our future success depends on our ability to hire and retain key executives and to attract, retain and motivate qualified personnel.
Our future success depends on our ability to attract and retain key management personnel and scientific and technical personnel. Experienced employees in the biopharmaceutical and biotechnology industries are in high demand and competition for their talents can be intense, especially in The Netherlands, where we maintain our principal operations. We have entered into employment agreements with executive officers and other key employees, but any employee may terminate his or her employment at any time or may be unable to continue in his or her role. The loss of any executive or key employee, or an inability to recruit desirable candidates or find adequate third parties to perform such services on reasonable terms and on a timely basis, could have a material adverse effect on our business, financial condition, results of operations and prospects. If we are not able to attract, retain and motivate necessary personnel to accomplish our business objectives, we may experience constraints that could significantly impede our ability to achieve our development and commercial objectives, our ability to raise additional capital and our ability to implement our business strategy.
Our business, products or product pricing could be subject to negative publicity, which could have a material adverse effect on our reputation, business, financial position, results of operations, liquidity and cash flows.
In recent years, the pharmaceutical industry has been the subject of public complaints and significant publicity regarding the pricing of pharmaceutical products, including publicity and pressure resulting from prices charged by competitors and peer companies for new products as well as price increases by competitors and peer companies on older products that the public has deemed excessive. We may experience downward pricing pressure on the price of RUCONEST®, Joenja® and any other future approved products due to social or political pressure to lower the cost of drugs, which could reduce our revenue and future profitability. Orphan drugs in particular have received recent negative publicity for the perceived high prices charged for them by their manufacturers, and as a result orphan drug developers such as us may be negatively impacted by such publicity and any U.S. or other government regulatory response. Due to these factors, we may suffer public criticism and negative publicity in media coverage, by industry trade associations and legislators.
Any of the events or developments described above could result in reputational harm and reduced market acceptance and demand for our products, could harm our ability to market our products in the future, could cause us to incur significant expense, could cause our senior management to be distracted from execution of our business strategy, and could have a material adverse effect on our business, reputation, financial condition, results of operations, liquidity, cash flows, and/or share price.
Future legislation regarding energy consumption and waste regulations might hamper efficiency of our operations.
Our facilities consume a significant amount of electricity in connection with the operation of our business and our production processes have a high consumption of consumables and liquid process waste. While we proactively improve processes where feasible with the aim to reduce use of energy and reduce the consumption of materials, our efforts to reduce energy consumption may not be successful. Additionally, we process waste such as chemicals for cleaning equipment (which need to be neutralized before disposing), milk waste, and fluids containing heavy metals.
Legislation related to waste regulations or legislation requiring our facilities to reduce our energy consumption may have a material impact on our business.
Risks Related to Intellectual Property
Our success is dependent on our ability to obtain and protect rights to proprietary technology and to develop our technology and products without infringing the proprietary rights of third parties.
We rely, and will continue to rely, on a combination of patents, trademarks and confidentiality agreements with employees, consultants, collaborators, advisors and other third parties to protect the intellectual property related to our current and future product candidates. We use patents and licensing to protect our products and technology. We try to be careful to develop products that don’t infringe on the proprietary rights of third parties. Currently, we have several patent applications granted and pending in countries including the U.S., Europe and Japan. The patent positions of pharmaceutical companies can be uncertain and may involve complex legal and factual questions.
The patents that we own and have license rights to now or the patents and patent applications that we may own or in-license in the future may not have patentable claims that protect our current and future product candidates in the relevant jurisdictions where we intend to commercialize such products. There is no assurance that we are aware of all potentially relevant prior art relating to current patents or current or future patent applications. As such, patent examiners may find prior art that can prevent a patent from issuing from a pending patent application. During the patent examination process, we may be required to narrow the pending claims to overcome prior art, a process that may limit the scope of patent protection. Even if patents do successfully issue based on our future patent applications, and even if the issued patents cover our current and future product candidates, including their compositions, formulation, method of manufacture, and method of use, third parties may challenge our issued patents’ validity, enforceability or scope, which may result in such patents being narrowed so that they no longer cover competitors’ products that are considered to infringe, invalidated or held unenforceable. Any successful opposition to these patents or any other patents owned by or licensed to us in the future could deprive us of rights necessary for the successful commercialization of any of our current or future product candidates, if approved. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product candidate under patent protection could be further reduced.
If the patent applications we may own or in-license with respect to our current and future product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for any of our current or future product candidates, it could dissuade other companies from collaborating with us to develop future product candidates, and threaten our ability to commercialize our current and future product candidates. Notably, pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Any such outcome could have an adverse effect on our business.
Moreover, our technologies and products may infringe on third-party intellectual property rights. As a result, we may face litigation or other legal proceedings concerning such intellectual property. These processes can be time-consuming and costly. In the event of an unfavorable ruling in patent or intellectual property litigation, we could be subject to significant liabilities to third parties, or be required to cease developing, manufacturing or selling the affected products or technology. Each of these outcomes may adversely affect our financial position. We may also be confronted with claims which are raised with the main aim of exploiting the nuisance value of publicly raised claims. In order to prevent the infringement of third-party intellectual property rights, we may need to acquire licenses for patents held by third parties to re-establish or maintain freedom to operate for our products, possibly on unfavorable terms. A failure to obtain licenses for patents held by third parties, or failure to obtain them on favorable terms, may have a material adverse effect on our financial and operational position.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. law does. Furthermore, publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.
Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.
In addition, if the breadth or strength of protection provided by our patents and patent applications, whether owned or in-licensed now or in the future, is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our licensed patents may be challenged in the courts or patent offices in the United States. Such challenges may result in loss of exclusivity or in patent claims being narrowed so that they no longer cover competitors’ products that are considered to infringe, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or unduly limit the duration of the patent protection of our technology and products. Moreover, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after the filing of the earliest non-provisional application to which the patent claims priority. Various extensions may be available; however, the exclusivity and protection afforded by a patent is limited. We may be required to disclaim a portion of patent term in order to overcome double patenting rejections from the patent office, thus potentially shortening our exclusivity period. Without patent protection for our current or future product candidates, we may be open to competition from generic versions of such products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
Competitors may infringe or otherwise violate our patents, the patents of our licensors or our other intellectual property rights. To counter infringement or unauthorized use, we may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that an asserted patent is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that the asserted patent does not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of asserted patents at risk of being invalidated or interpreted narrowly and could put a related patent application at risk of not issuing. The initiation of a claim against a third party may also cause the third party to bring counter claims against us such as claims asserting that our patents are invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the U.S. Patent and Trademark Office, or the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte re-examinations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation. Third parties may also make it more difficult to obtain patents to our valuable technologies by engaging in pre-issuance submissions of prior art to the USPTO and in analogous proceedings in other jurisdictions. The outcome following legal assertions of invalidity and unenforceability is unpredictable. We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For the patents and patent applications that we may license in the future, we may have limited or no right to participate in the defense of any licensed patents against challenge by a third party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our current or future product candidates. Such a loss of patent protection could harm our business.
We may not be able to detect or prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States. Our business could be harmed if in litigation the prevailing party does not offer us a license on commercially reasonable terms. Any litigation or other proceedings to enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.
Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our ordinary shares.
We may infringe or be alleged to infringe the intellectual property rights of others, which may prevent or delay product development and commercialization efforts, requiring us to expend resources on litigation or other resolutions, which may materially and adversely affect our business.
Our success depends, in part, on our ability to operate without infringing the intellectual property rights and other proprietary rights of third parties. Identification of third-party patent rights that may be relevant to our products and proprietary technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty and uncertainty in assessing the meaning or scope of protection of patent claims. There could be issued patents of which we are or were not aware that our products infringe. There also could be patents that we believe we do not infringe, but that we may ultimately be found to infringe. Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents can take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our products infringe. For example, pending applications may exist that provide support or can be amended to provide support for a claim that results in an issued patent that our product infringes. We may also be confronted with claims which are raised with the main aim of exploiting the nuisance value of publicly raised claims.
Proceedings involving our patents or patent applications or those of others could:
•put one or more of our patents at risk of being invalidated, rendered unenforceable or interpreted narrowly so that they no longer cover competitors’ products that are considered to infringe;
•adversely impact the patentability of our inventions relating to our products;
•result in monetary damages, injunctive relief or otherwise harm our competitive position, including by limiting or terminating marketing and selling activities, increasing the risk for generic competition, limiting development and commercialization activities or requiring us to obtain licenses to use the relevant technology (which licenses may not be available on commercially reasonable terms, if at all); and
•otherwise negatively impact the enforceability, validity or scope of protection offered by the patents relating to the products.
We may not have the resources to adequately defend such claims, and even if successful in any such proceedings, we would incur substantial costs and divert management’s time and attention in pursuing these proceedings, putting further strain on our resources, which could have a material adverse effect on our business, financial condition, results of operations and prospects. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court or other venue. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion.
In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, we may:
•incur substantial monetary damages;
•encounter significant delays in expanding the market of our products; and
•be precluded from manufacturing or selling any products; which, in each case, could have a material adverse effect on our business, financial condition, results of operations and prospects.
Our patents may be challenged, deemed unenforceable, invalidated or circumvented, and if we do not obtain or maintain patent protection for the products, our business may be materially harmed.
The patent positions of biotechnology and pharmaceutical companies involve complex legal and factual questions and, therefore, validity and enforceability cannot be predicted with certainty. U.S. patents and patent applications also may be subject to interference proceedings, ex parte reexamination, inter partes review, or IPR, and post-grant review proceedings, derivation proceedings and supplemental examination and may be challenged in district courts. Patents granted in certain other countries may be subjected to opposition or comparable proceedings lodged in various national and regional patent offices. These proceedings could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application (so that, for example, they no longer cover competitors’ products that are considered to infringe). In addition, such interference, re-examination, opposition, post-grant review, IPR, derivation proceedings, supplemental examination or revocation proceedings may be costly. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary technologies are covered by valid and enforceable patents or are effectively maintained as trade secrets. The degree of future protection for our products and proprietary rights is uncertain, and it cannot be guaranteed that:
•we will be able to successfully develop or commercialize our product before some or all of the relevant patents or regulatory exclusivity expire, or in countries where we do not have patent protection or exclusivity;
•we or our licensors were the first to make the inventions covered by each of the pending patent applications and patents;
•we or our licensors were the first to file patent applications for these inventions;
•others will not independently develop similar or alternative technologies or duplicate any of our technologies;
•any of our pending patent applications or those that we have licensed will result in issued patents;
•any of our patents or those we have licensed will be valid or enforceable;
•we will be able to license the patents or pending patent applications necessary or desirable to enforce or protect our patent rights on commercially reasonable terms or at all;
•any patents issued to us or our licensors or collaborators will provide a basis for protection of any existing or additional commercially viable products, will provide us with any competitive advantages or will not be successfully challenged by third parties;
•we will be able to develop additional proprietary technologies that are patentable; or
•the patents of others will not have an adverse effect on our business.
Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. For example, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, made a number of significant changes to United States patent laws. These include provisions that affect the way patent applications are prosecuted and challenged at the USPTO and may also affect patent litigation. The USPTO has developed and continues to develop new regulations and procedures to govern administration of the Leahy-Smith Act. Accordingly, it remains unclear what impact the Leahy-Smith Act, subsequent rule-making, and judicial interpretation of the Leahy-Smith Act and regulations will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have an adverse effect on our business and financial condition. Moreover, future changes to the patent laws of the United States and foreign jurisdictions may adversely affect the term, scope, validity and enforceability of our or our licensors’ patent rights. For example, a 2019 bill (Terminating the Extension of Rights Misappropriated Act, or TERM Act, H.R. 3199) in the United States Congress aimed to reduce the term of certain drug patents in order to ease generic entry and increase competition. Changing political priorities could potentially drive more such initiatives.
In addition, the U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit have issued numerous precedential opinions in recent years narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of these decisions and legislative changes has created uncertainty with respect to the value of patents, once obtained. Depending on actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce patents that we have licensed or that we might obtain in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain in the future. The U.S. federal government retains certain rights in inventions produced with its financial assistance under the Bayh-Dole Act. The federal government retains a ''nonexclusive, non-transferable, irrevocable, paid-up license'' for its own benefit. The Bayh-Dole Act also provides federal agencies with ''march-in rights.'' March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a ''nonexclusive, partially exclusive, or exclusive license'' to a ''responsible applicant or applicants.'' If the patent owner refuses to do so, the government may grant the license itself.
We enjoy only limited geographical protection with respect to certain patents.
Filing and prosecuting patent applications and defending patents covering product candidates in all countries throughout the world would be prohibitively expensive. Competitors may use our and our licensors’ technologies in jurisdictions where patent protection has not yet been obtained to develop their own products or may export infringing products to territories where enforcement rights are not as strong as in the United States or EU, or where enforcement rights do not exist. These products may compete with our product candidates, and our intellectual property rights may not be effective or sufficient to prevent such products from competing. Patent applications may be issued in some non-U.S. jurisdictions with different scope or they may be refused in certain jurisdictions, such as, for example. China, India, Brazil, which have different requirements for patentability.
Proceedings to enforce our patent rights in other jurisdictions, whether or not successful, could result in substantial costs and divert efforts and attention from other aspects of the business. They could also put our patents and patent applications at risk of being invalidated, denied or interpreted narrowly, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits or have damages or other remedies awarded to us, or such damages or other remedies may not be commercially meaningful. Accordingly, our intellectual property rights as enforced may be inadequate to obtain a significant commercial advantage and our efforts to protect our intellectual property rights may be unsuccessful or inadequate, which may adversely affect our ability to successfully commercialize our product candidates, and which may have a material adverse effect on our business, financial condition, results of operations and prospects. Furthermore, while we intend to protect our intellectual property rights in our expected significant markets, we cannot ensure that we will be able to initiate or maintain similar efforts in all jurisdictions in which we may wish to market our product candidates. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate, which may have an adverse effect on our ability to successfully commercialize our drug candidates in all of our expected, significant international markets.
Many countries also have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties or laws limiting the enforceability of patents against government agencies or government contractors under certain circumstances. In those countries, a patent owner may have limited recourse, which could materially diminish the value of such patents. If we or any of our licensors are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be adversely affected.
If intangible assets and goodwill that we record in connection with our acquisitions become impaired, we may have to take significant charges against earnings.
In connection with the accounting for our acquisitions, a significant value may be recognized in respect of intangible assets, including developed technology and customer relationships relating to the acquired product lines, and goodwill.
Under IFRS, we must assess, at least annually and potentially more frequently, whether the value of intangible assets and goodwill has been impaired. We expect to assess intangible assets and goodwill for impairment in the event of an impairment indicator. Any reduction or impairment of the value of intangible assets and goodwill will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods.
Our global operations subject us to significant tax risks.
We are subject to tax rules in the jurisdictions in which we operate. Changes in tax rates, tax relief and tax laws, changes in practice or interpretation of the law by the relevant tax authorities, increasing challenges by relevant tax authorities or any failure to manage tax risks adequately could result in increased charges, financial loss, penalties and reputational damage. Tax authorities may pursue additional taxes based on retroactive changes to tax laws which could result in a material restatement to our tax position. Any of these factors could have a negative impact on our business, financial condition, results of operations and prospects.
Risks Related to Government Regulation Compliance, Legal Matters, and Reputation
We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, antitrust and competition laws, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, or the FCPA, the United States domestic bribery statute contained in 18 U.S.C. § 201, the United States Travel Act, the USA PATRIOT Act, certain prohibitions under the Dutch Criminal Code (Wetboek van Strafrecht), the Dutch Economic Offences Act (Wet op Economische Delicten), the U.K. Bribery Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities or countries that are otherwise relevant for our activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors and other partners from authorizing, promising, offering, or providing, directly or indirectly, payments, or anything else of value to recipients in the public or private sector (in relation to an act or omission (to be or having been) by the recipient). We may have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other partners, even if we do not explicitly authorize or have actual knowledge of such activities, and we may participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the FCPA, the U.K. Bribery Act or local anti-corruption laws. We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United States and authorities in the EU, including applicable export control regulations, economic sanctions and embargoes on certain countries and persons, anti-money laundering laws, import and customs requirements, and currency exchange regulations.
Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, disgorgement, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.
If we fail to comply with United Kingdom, EU or U.S. privacy and data security laws and regulations, we may be subject to civil and criminal penalties and other liability.
We are also subject to laws and regulations covering data privacy and the protection of health-related and other personal information. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues which may affect our business, including recently enacted laws in many jurisdictions where we operate. The collection and use of personal data (including health data) in the EU is governed by the provisions of the GDPR. This regulation, which is wide-ranging in scope and includes extraterritoriality provisions that apply to certain entities located outside of the EU, imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, notification of personal data breaches to the competent national data protection authorities and the security and confidentiality of the personal data, and substantial fines for breaches of the data protection rules.
The GDPR also imposes strict rules on the transfer of personal data out of the EU to other countries (including the United States). Failure to comply with the requirements of the GDPR and the related national data protection laws of the EU Member States and the United Kingdom may result in large fines and other administrative penalties: a failure to comply could result in fines up to the greater of 4% of annual worldwide turnover for the preceding financial year or €20 million, with infringements being grouped into tiers which trigger different maximum fine levels. Turnover in this context may include not only the entity in breach but also other group entities. Recent enforcement actions against multinational companies have resulted in significant fines.
Following the United Kingdom’s formal departure from the EU on January 31, 2020, the United Kingdom adapted and implemented the GDPR into its national law, as a result of the United Kingdom’s Data Protection Act 2018, or DPA. The DPA supplements the GDPR, and in particular sets out specific requirements related to the processing of ''special categories of personal data'', including personal data related to health, genetic information and personal data related to criminal offenses or convictions. The DPA also creates a number of criminal offenses (punishable by uncapped fines) for organizations and in certain cases their directors and officers. Since the United Kingdom left the EU and the transition period has expired, the United Kingdom became a “third country” for the purposes of EU data protection law.
A “third country” is a country other than the EU Member States and the three additional European Economic Area countries (Norway, Iceland and Liechtenstein) that have adopted a national law implementing the GDPR. Under the GDPR, personal data can only be transferred to third countries in compliance with specific conditions for cross-border data transfers. Unless an exemption applies, appropriate safeguards are required to enable transfers of personal data from the EU and EEA Member States. However, on June 28, 2021, the European Commission adopted an adequacy decision in relation to the United Kingdom. With this decision, the European Commission considers that personal data benefits from an essentially equivalent level of protection under UK law to that guaranteed under EU law, and thus allows personal data to flow freely from the EEA to the United Kingdom. This adequacy decision is however limited in time, and its renewal will depend on whether the United Kingdom continues to ensure an adequate level of data protection. As the United Kingdom is currently looking to reform its data protection regime, there is uncertainty as to whether the United Kingdom will be able to maintain its adequacy status in the future. Similarly, the European Commission adopted its adequacy decision for the EU-U.S. Data Privacy Framework on July 10, 2023, allowing the transfer of personal data from the EEA to U.S. companies participating in the EU-U.S. Data Privacy Framework.
Under the GDPR regulations, we are considered a controller of data processing and are subject to several legal obligations. In particular, we are obligated to place importance on collection and processing of special categories of personal data which, for our purposes, is data that reveals genetic data or data concerning health. While we have taken steps to comply with the GDPR and the DPA, we cannot assure you that our efforts to achieve and remain in compliance have been or will continue to be fully successful. The GDPR regulations and the DPA may impose additional responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with these or new data protection rules. This may be onerous and adversely affect our business, financial condition, results of operations and prospects.
In addition, we obtain patient health information from most healthcare providers that prescribe our products and research institutions with which we collaborate, and they are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996, or HIPAA, in the United States. Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we could potentially be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. There are also state laws on patient health information, such as the California Confidentiality of Medical Information Act, which we are more directly subject to. As more states consider implementing such laws, we may face an ever-expanding patchwork of data privacy regulations.
Failure to comply with healthcare laws and laws and regulations covering data privacy and the protection of health-related and other personal information could result in government enforcement actions, which could include civil or criminal penalties, private litigation and adverse publicity and could negatively affect our business, financial condition, results of operations and prospects.
Our current and future relationships with healthcare professionals, customers and third-party payors are subject to applicable anti-kickback, fraud and abuse, privacy and security, transparency, and other healthcare laws and regulations, which could expose us to significant penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
We are subject to healthcare statutory and regulatory requirements and enforcement by the U.S. federal government and the states and foreign governments in the jurisdictions in which we conduct our business. Third-party payors play a primary role in the approval of prescriptions for RUCONEST® and Joenja®, and we expect will do so for any product candidates for which we obtain marketing approval. Our current and future arrangements with third-party payors, healthcare practitioners and patients may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we research as well as market, sell and distribute any products for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations in the United States include the following:
•the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or paying remuneration, directly or indirectly, in cash or in-kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid; a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
•the federal false claims laws, including the civil False Claims Act, impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; in addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;
•HIPAA imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
•the federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act” under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or, collectively, the ACA, require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to Centers for Medicare & Medicaid Services, or CMS, information related to payments and other transfers of value to physicians, as defined by such law, and teaching hospitals and the ownership and investment interests of physicians and their immediate family members in such manufacturers. Beginning in 2022, applicable manufacturers also will be required to report such information regarding its relationships with physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives during the previous year;
•HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which also imposes obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates, and their subcontractors, that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
•ACA, analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;
•some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;
•state and local laws that require the registration of pharmaceutical sales representatives;
•state and foreign laws also govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts;
•competition laws in the U.S. and globally that may govern our interactions with competitors, customers, distributors, and suppliers; and
•the FCPA prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business.
Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to it, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs that we participate in, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
We have certain price reporting obligations to the Medicaid Drug Rebate Program. Under the Medicaid Drug Rebate Program, we are required to pay a rebate to each state Medicaid program for RUCONEST® and Joenja®, and expect to do so for any new approved products. Those rebates are based on pricing data we have to report on a monthly and quarterly basis to CMS, the federal agency that administers the Medicaid Drug Rebate Program. These data include, among other things, the Average Manufacturing Price, or AMP, and the Best Price, or BP, which, in general, represents the lowest price available from the manufacturer to any entity in the U.S. in any pricing structure, calculated to include all sales and associated rebates, discounts and other price concessions. On December 31, 2020, CMS promulgated a final rule that, among other things, changed the methodology for calculating and reporting of AMP and BP in order to encourage manufacturers and states to enter into value-based purchasing arrangements. We are liable for errors associated with our submission of pricing data and for any overcharging of government payors. For example, failure to submit monthly/quarterly AMP and BP data on a timely basis could result in a civil monetary penalty for each day the submission is late beyond the due date. Failure to make necessary disclosures and/or to identify overpayments could result in allegations against us under the Federal False Claims Act and other laws and regulations. Any required refunds to the U.S. government or responding to a government investigation or enforcement action would be expensive and time consuming and could have a material adverse effect on our business, results of operations and financial condition.
U.S. federal law requires that any company that participates in the Medicaid Drug Rebate Program also participate in the 340B program in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B. The 340B program requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs. These 340B covered entities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low- income patients. The ACA expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals, but exempts “orphan drugs” from the ceiling price requirements for these covered entities. The 340B ceiling price is calculated using a statutory formula based on the AMP and rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program, and in general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B ceiling price calculation and discount requirement.
Any additional future changes to the definition of AMP and the Medicaid rebate amount under the ACA or other legislation or regulation could affect our 340B ceiling price calculations and negatively impact our results. In addition, legislation may be introduced that, if passed, would further expand the 340B program to additional covered entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.
RUCONEST® has been approved by the FDA, the European Commission and certain other regulatory authorities for the treatment of HAE attacks. Regulatory approval is limited to the specific indication for which approval has been granted and, unless we seek regulatory approval for additional indications, we will be prohibited from marketing RUCONEST® for other indications. We may be subject to significant fines, penalties or injunctions if we are determined to have promoted or be promoting the use of RUCONEST® for unapproved or “off-label” uses, resulting in damage to our reputation and business.
RUCONEST® is approved by the FDA, the European Commission and certain other regulatory authorities for the treatment of HAE attacks, but is not currently approved for the treatment of other indications. Regulatory authorities strictly regulate the promotional claims that may be made about prescription products, and RUCONEST® may not be promoted for uses that are not approved, as reflected in its approved labeling. If we are not able to obtain regulatory approval for any desired future indications for our products and product candidates, our ability to effectively market and sell our products may be reduced and our business may be adversely affected.
While physicians may choose, in their independent medical judgment, to prescribe products for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, we are prohibited from marketing and promoting the products for indications that are not specifically approved by the regulatory authorities. These “off-label” uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances. Regulatory authorities in the United States and in other jurisdictions generally do not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine. Regulatory authorities do, however, restrict communications by biotechnology or pharmaceutical companies on off-label use. If the FDA or another regulator determines that our promotional activities constitute promotion of an off-label use, it could request that we modify our promotional materials and subject us to regulatory or enforcement actions as well as actions by other agencies, including issuance of warning letters or untitled letters, suspension or withdrawal of an approved product from the market, mandatory or voluntary recalls, and could result in the imposition of significant criminal, civil, and administrative penalties such as civil fines, disgorgement of money, imprisonment, exclusion from participation in federal health care programs (e.g. Medicare and Medicaid), operating restrictions, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement, injunctions or criminal prosecution, any of which could significantly harm our business.
Current and future healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
In the United States and in some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative and regulatory changes and proposed changes intended to broaden access to healthcare, improve the quality of healthcare and contain or lower the cost of healthcare. For example, the ACA substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S. pharmaceutical industry. The ACA, among other things, subjects biological products to potential competition by lower-cost biosimilars, expands the types of entities eligible for the 340B drug discount program, addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increases rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, establishes annual fees and taxes on manufacturers of certain branded prescription drugs and creates a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, or BBA, effective as of January 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.
Since its enactment, there have been numerous judicial, administrative, executive and legislative challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. In addition, the implementation of the ACA is ongoing, and the law appears likely to continue the downward pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs. Litigation and legislation related to the ACA are likely to continue, with unpredictable and uncertain results.
In addition, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several congressional inquiries and proposed legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient assistance programs and reform government program reimbursement methodologies for pharmaceutical and biological products. At the federal level, the previous administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives. For example, on July 24, 2020 and September 13, 2020, the Trump administration announced several executive orders related to prescription drug pricing that attempted to implement several of the administration’s proposals, one of which has since been rescinded. As a result, the FDA released a final rule on September 24, 2020, effective November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. On January 5, 2024, the FDA authorized the state of Florida to import certain prescription drugs from Canada.
Further, on November 20, 2020, the U.S. Department of Health and Human Services, or HHS, finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Medicare Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The implementation of the rule has been delayed by the Inflation Reduction Act of 2022, or IRA, until 2032.
The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers, the implementation of which has also been delayed by the IRA until January 1, 2032. Further, authorities in Canada have passed rules designed to safeguard the Canadian drug supply from shortages. If implemented, importation of drugs from Canada may materially and adversely affect the price we receive for any of our product candidates. It is unclear whether the Biden administration will work to reverse these measures or pursue similar policy initiatives. Additionally, on July 9, 2021, President Biden issued an executive order directing the FDA to, among other things, continue to clarify and improve the approval framework for generic drugs and identify and address any efforts to impede generic drug competition.
Additionally, on August 16, 2022, President Biden signed the IRA into law. The IRA, among other things, (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. These provisions have taken effect progressively starting in fiscal year 2023, although they have been subject to legal challenges. It is currently unclear how the IRA will be effectuated but it is likely to have a significant impact on the pharmaceutical industry.
At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional health care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other health care programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.
We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our services by our partners or for our current or future drug candidates.
We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our drug candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.
Our employees and independent contractors, including principal investigators, consultants, any future commercial collaborators, service providers, and other vendors may engage in misconduct or other illegal activity.
Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
Misconduct by these parties could include intentional, reckless and/or negligent conduct or other unauthorized activities that violate the laws and regulations of the FDA and other similar regulatory bodies, including those laws that require the reporting of true, complete and accurate information to such regulatory bodies; manufacturing standards; U.S. federal and state healthcare fraud and abuse laws, data privacy and security laws and other similar non-U.S. laws; or laws that require the true, complete and accurate reporting of financial information or data. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs, and other business arrangements. Such misconduct also could involve the improper use or misrepresentation of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, the creation of fraudulent data in our preclinical studies or clinical trials, or illegal misappropriation of product, which could result in regulatory sanctions and cause serious harm to our reputation.
It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. In addition, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and financial results, including, without limitation, the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, possible exclusion from participation in Medicare, Medicaid, and other U.S. federal healthcare programs or healthcare programs in other jurisdictions, integrity oversight and reporting obligations to resolve allegations of non-compliance, imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
There are material weaknesses in our internal control over financial reporting and if we are unable to remediate them, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal control, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and stock price.
We have identified material weaknesses in our internal control over financial reporting across the principles for each component of the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, framework (i.e., control environment, risk assessment, monitoring, information and communication and control activities) at the entity level and accordingly, across the business and IT processes of the Company. The material weaknesses that we identified relate to each of the five components of the COSO framework. See "Item 15 - Controls and Procedures" for additional information. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and stock price.
In 2021, with the assistance of outside consultants, we established a compliance roadmap to work towards remediating material weaknesses in our internal control over financial reporting. In addition, during 2023, we established a control implementation plan and have been actively working on implementing key controls. As part of those efforts, we have, among other things, expanded hiring in our Finance and Internal Control functions and engaged an external party in testing the operating effectiveness of our internal control. We began the first round of operational effectiveness testing in the second half of 2023 and intend to undergo multiple rounds of operational effectiveness testing in 2024. However, we will not be able to fully remediate the material weaknesses until all of these steps have been completed and have been operating effectively for a sufficient period of time.
We have identified material weaknesses in our internal control over financial reporting across the principles for each component of the COSO framework since we became subject to the reporting requirements of the Exchange Act. We cannot assure you that we will be able to successfully remediate these material weaknesses or that other material weaknesses will not be discovered in the future. In addition, these efforts have caused us, and we expect will continue to cause us, to expend significant resources, including diverting management’s attention from other business concerns.
We are required, pursuant to Section 404(a) of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting on an annual basis. This assessment includes disclosure of any material weaknesses identified by our management in our internal control over financial reporting. Our Management’s Annual Report on Internal Control over Financial Reporting included in this Annual Report describes these material weaknesses and includes our conclusion that our internal controls were not effective as of the end of the period covered by this Annual Report. Additionally, an adverse opinion from our independent registered public accounting firm on our internal control over financial reporting is included in this Annual Report.
Our inability to conclude that we have effective internal control over financial reporting and out auditors’ inability to provide us with an unqualified report on the effectiveness of our internal control over financial reporting, as required by Section 404, may (i) cause investors to lose confidence in the accuracy or completeness of our financial reports, (ii) cause the price of our ADSs or ordinary shares to decline and (iii) subject us to litigation, sanctions or investigations by regulatory authorities, including the SEC and Nasdaq. Failure to remediate the material weaknesses in our internal control over financial reporting could also restrict our future access to the capital markets. In addition, if we are unable to meet the requirements of Section 404, we may not be able to remain listed on Nasdaq.
Our business and operations may be negatively impacted by the failure, or perceived failure, of achieving environmental, social and governance, or ESG, objectives.
We continue to work towards operating our business in an environmentally responsible and socially inclusive manner. Stakeholders, including our stockholders and our employees, have increasingly focused on our ESG practices. If our ESG practices fail to meet these stakeholders’ expectations and standards, there could be a material adverse effect on our reputation, business and, ultimately, our stock price.
Achieving our ESG goals requires long-term investments and broad, coordinated collaboration which may require us to incur additional costs or allocate additional resources towards monitoring, reporting, and implementing our ESG practices. Furthermore, we may fail to accurately assess our stakeholders’ ESG priorities, as such priorities have evolved and will continue to evolve. Any failure or perceived failure to meet our ESG program priorities could result in a material adverse effect on our reputation, business, and stock price.
Risks Related to Financial Conditions, Market Environment and General Economic Trends
Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets, including inflation and supply disruption.
A domestic or global financial crisis can cause extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for our product candidates or an inability to purchase necessary supplies on acceptable 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 payors or our collaborators. In addition, recent geopolitical tensions and conflicts, including the conflict in the Middle East and Ukraine, has had significant ramifications on global financial markets, which may adversely impact our ability to raise capital on favorable terms or at all. 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.
Due to the international scope of our operations, fluctuations in exchange rates, particularly between the Euro and the U.S. dollar, may adversely affect us.
While we are headquartered in The Netherlands, we source materials, products and services from several countries outside the EU that are paid in local currencies. As a result of the commercialization of Joenja® in the United States and RUCONEST® in the United States and in other countries outside the EU, we will also receive payments and generate costs in U.S. dollars and other currencies. As a result, our business may be affected by fluctuations in foreign exchange rates between the Euro and the U.S. dollar, as well as other currencies.
Since the majority of our sales are invoiced and paid in U.S. dollars, and the majority of our costs and liabilities are valued in Euros, any change in the relevant exchange rate means a corresponding change in the Euro value of sales and a corresponding change in the loan balance in Euros. While we maintain U.S. dollar cash deposits, the functional currency of the Dutch Pharming entities is the Euro, so any change in the U.S. dollar-Euro exchange rate means a corresponding change in the Euro value of U.S. dollar cash deposits.
Adverse capital and credit market conditions may significantly affect the ability to meet liquidity needs, access to capital and cost of capital.
We utilize cash flow from operations to invest in our future projects. However, prolonged exposure to liquidity risk or inability to generate enough income for the currently contemplated projects, could lead to the inability to meet our financial obligations, which could increase the risk of insolvency.
Additionally, adverse developments in the capital and credit markets, for example as the result of rising interest rates globally, would affect our ability to finance our operations and could materially impact our results of operations.
Risks Related to the ADSs
As a “foreign private issuer,” we are exempt from a number of rules under the U.S. securities laws and the Nasdaq Stock Market LLC, or Nasdaq, rules, and we are permitted to file less information with the SEC than are U.S. companies. In addition, we are permitted and follow certain home country corporate governance practices in lieu of certain Nasdaq requirements applicable to domestic issuers. This may make our American Depositary Shares, or ADSs, and ordinary shares less attractive to investors.
We are a “foreign private issuer,” as defined in the rules and regulations of the SEC, and, consequently, we are not subject to all of the disclosure and governance requirements applicable to companies organized within the United States. For example, we are exempt from certain rules under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under the Exchange Act. In addition, our officers and directors are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. public companies. Accordingly, there may be less publicly available information concerning our Company than there is for U.S. public companies.
As a foreign private issuer traded on Euronext Amsterdam, we are permitted to follow certain home country corporate governance practices in lieu of certain requirements of the Nasdaq. The rights of holders of ordinary shares and, therefore, certain of the rights of holders of the ADSs, are governed by Dutch law, including the provisions of the Dutch Corporate Governance Code, or the DCGC, and by our Amended and Restated Articles of Association, which may provide less protection than is afforded to investors under Nasdaq rules applicable to domestic issuers.
In particular, we follow Dutch law instead of Nasdaq practice in the following ways:
•We do not follow Nasdaq Rule 5620(c) regarding quorum requirements applicable to meetings of shareholders as long as we are not a domestic issuer and absent another mandatory obligation to such effect. Such quorum requirements are not required under Dutch law. In accordance with generally accepted business practice, our Amended and Restated Articles of Association provide alternative quorum requirements that are generally applicable to meetings of shareholders.
•We do not follow Nasdaq Rule 5605(b)(2), which requires that independent directors regularly meet in an executive session, where only independent directors are present. The independent directors may choose to meet in an executive session at their discretion.
As a result of the above, holders of the ADSs do not have the same protections afforded to shareholders of companies that are not foreign private issuers.
If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding the ADSs adversely, the price and/or trading volume of the ADSs could be affected.
The trading market for the ADSs representing our ordinary shares may be influenced by the research and reports that industry or securities analysts publish about us or our business. If one or more of the analysts who cover us or our industry downgrade the shares in a research report, the market price of the shares may decline and if one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, we could lose visibility in the financial markets, which could cause the market price and/or trading volume of the shares to decline.
The price and trading volume of the ADSs and ordinary shares may be volatile, and purchasers of the ADSs or ordinary shares could incur substantial losses.
The market price of the ADSs is likely to be volatile and could decline significantly. The stock market in general, and the market for biotechnology and emerging pharmaceutical companies in particular, have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.
The market price for the ADSs and ordinary shares may be influenced by a variety of factors, including:
•actual or anticipated variations in our financial condition and operating profit;
•actual or anticipated changes in our growth rate relative to our competitors;
•announcements of technological partnerships, innovations or new products by us or our competitors;
•the success of competitive products or technologies;
•changes in management and members of our board of directors;
•changes in financial estimates or recommendations by securities analysts;
•changes in the trading volume of the ADSs on the Nasdaq and of our ordinary shares on Euronext Amsterdam;
•sales of the ADSs or our ordinary shares by executive officers or future holders of our equity securities;
•announcements or expectations of additional debt or equity financing efforts;
•unanticipated losses or gains due to unexpected events, including events related to the success of our clinical trials or regulatory approvals;
•significant acquisitions or business combinations, strategic partnerships, joint ventures or capital commitments by or involving us or our competitors;
•changes in our accounting policies or practices;
•disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
•changes in government regulations, including any changes that may affect pricing or reimbursement; and
•conditions in the financial markets or changes in general economic conditions.
These and other market and industry factors may cause the market price and demand for the ADSs and ordinary shares to fluctuate substantially.
Moreover, securities of life science companies, and stock markets in general, have from time to time experienced extreme price and volume fluctuations that may be unrelated or disproportional to the operational performance of any particular companies.
We will incur increased costs as a result of simultaneously having the ADSs listed in the United States and our ordinary shares admitted to trading on Euronext Amsterdam in The Netherlands, and our senior management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
As a company whose securities are publicly listed in the United States, we will incur significant legal, accounting and other expenses that we did not incur previously, even though our ordinary shares are admitting to trading on Euronext Amsterdam. Our senior management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified senior management personnel or members for our board of directors.
However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
Further, being a U.S. listed company and a Dutch public company with ordinary shares admitted to trading on Euronext Amsterdam impacts the disclosure of information and requires compliance with two sets of applicable rules. From time to time, this may result in uncertainty regarding compliance matters and result in higher costs necessitated by legal analysis of dual legal regimes, ongoing revisions to disclosure and adherence to heightened governance practices. As a result of the enhanced disclosure requirements of the U.S. securities laws, business and financial information that we report is broadly disseminated and highly visible to investors, which we believe may increase the likelihood of threatened or actual litigation, including by competitors and other third parties, which could, even if unsuccessful, divert financial resources and the attention of our management and key employees from our operations.
Future sales of our ordinary shares or ADSs, or the perception that such sales may occur, could depress the prices of such ordinary shares or ADSs.
Sales of a substantial number of the ADSs in the public market, or the perception that these sales might occur, could depress the market price of the ADSs and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market price of our ADSs.
We are a Dutch public company with limited liability. The rights of our shareholders and ADS holders may be different from the rights of shareholders in companies governed by the laws of U.S. jurisdictions and may not protect investors in a similar fashion afforded by incorporation in a U.S. jurisdiction.
We are a public company (naamloze vennootschap) organized under the laws of The Netherlands. Our corporate affairs are governed by our Amended and Restated Articles of Association, the rules of our board of directors and by the laws governing companies incorporated in The Netherlands. However, there can be no assurance that Dutch law will not change in the future or that it will serve to protect investors in a similar fashion afforded under corporate law principles in the United States, which could adversely affect the rights of investors.
The rights of shareholders and ADS holders and the responsibilities of directors may be different from the rights and obligations of shareholders, ADS holders and directors in companies governed by the laws of U.S. jurisdictions. In the performance of their duties, our directors are required by Dutch law to consider the interests of our Company, its shareholders, its employees and other stakeholders, in all cases with due observation of the principles of reasonableness and fairness. It is possible that some of these parties will have interests that are different from, or in addition to, your interests as an ADS holder.
For more information on relevant provisions of Dutch corporation law and of our Amended and Restated Articles of Association, see “Description of Securities” included as Exhibit 2.1 to this Annual Report.
Provisions of our Amended and Restated Articles of Association or Dutch corporate law might deter acquisition bids for us that might be considered favorable and prevent, delay or frustrate any attempt to replace or remove the members of our board of directors.
Under Dutch law, various protective measures are possible and permissible within the boundaries set by Dutch law and Dutch case law.
Certain provisions of our Amended and Restated Articles of Association may make it more difficult or less attractive for a third party to acquire control of us or to effect a change in our board of directors. These provisions include: a provision that our directors are appointed on the basis of a binding nomination prepared by our board of directors which can only be overruled by a simple majority of votes cast representing at least one third of our issued share capital; a provision that our directors may only be removed by the general meeting of shareholders by a simple majority of votes cast representing at least one third of our issued share capital; and a requirement that certain matters, including an amendment of our Amended and Restated Articles of Association, may only be brought to our shareholders for a vote upon a proposal by our board of directors. Currently we have no such protective measures in place.
Shareholders and ADS holders may not be able to exercise preemptive rights and, as a result, may experience substantial dilution upon future issuances of ordinary shares.
In the event of an issuance of ordinary shares, subject to certain exceptions, each shareholder will have a pro rata preemptive right in proportion to the aggregate nominal value of the ordinary shares held by such holder. These preemptive rights may be restricted or excluded by a resolution of the general meeting or by another corporate body designated by the general meeting. For example, at our 2022 Annual General Meeting, our shareholders approved a proposal to exclude preemptive rights for up to 10% of our issued share capital for general corporate purposes and for up to 10% of our issued share capital for financing of mergers, acquisitions, and strategic alliances, each for a period of eighteen months. The issuance of additional equity securities in the absence of preemptive rights would cause existing shareholders to experience dilution of their interest in us.
We are not obligated to, and do not, comply with all best practice provisions of the Dutch Corporate Governance Code.
We are subject to the DCGC. The DCGC contains both principles and best practice provisions for boards of directors, shareholders and general meetings, auditors, disclosure, compliance and enforcement standards. As a Dutch company listed on a stock exchange, we are subject to the DCGC and are required to disclose in our annual board report to what we extent comply with the principles and best practice provisions of the DCGC, and where we do not (for example, because of a conflicting Nasdaq requirement or otherwise), we must state why and to what extent we deviate in our Annual Report. We do not comply with all best practice provisions of the DCGC. See “Description of Securities” included as Exhibit 2.1 to this Annual Report. This may affect your rights as a shareholder or ADS holder and you may not have the same level of protection as a shareholder or ADS holder in a Dutch company that fully complies with the DCGC.
We have never declared or paid dividends on our ordinary shares since our ordinary shares were listed on Euronext Amsterdam, and we do not anticipate paying dividends in the foreseeable future.
We have never declared or paid cash dividends on our ordinary shares since our ordinary shares were listed on Euronext Amsterdam. We intend to retain any earnings for use in our business and do not currently intend to pay dividends on our ordinary shares. Subject to restrictions under applicable law, any future determination to pay dividends or other distribution will be at the discretion of our board of directors and will depend upon a number of factors, including our results of operations, cash requirements, financial condition, future prospects, contractual restrictions, any future debt agreements, restrictions under applicable laws and other factors that our board of directors may deem relevant. We do not anticipate paying any cash dividends or other distributions on our ordinary shares in the foreseeable future. As a result, a return on any investment will only occur if the price of our ordinary shares or the ADSs increases.
ADS holders may not receive distributions on the ordinary shares represented by the ADSs or any value for such distribution if it is illegal or impractical to make them available to ADS holders.
While we do not anticipate paying any dividends or other distributions on our ordinary shares in the foreseeable future, if such a dividend or distribution is declared, the depositary for the ADSs has agreed to pay to you the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses, including any applicable withholding taxes. You will receive these distributions in proportion to the number of ordinary shares your ADSs represent. However, in accordance with the limitations set forth in the deposit agreement, it may be unlawful or impractical to make a distribution available to ADS holders. We have no obligation to take any other action to permit the distribution of the ADSs, ordinary shares, rights or anything else to holders of the ADSs. This means that you may not receive the distributions we make on our ordinary shares or any value from them if it is unlawful or impractical to make them available to you. These restrictions may have a material adverse effect on the value of your ADSs.
Dividends distributed by us on the ordinary shares or ADSs to certain related parties in low-taxed jurisdictions might in the future become subject to an additional Dutch withholding tax on dividends.
Under current Dutch tax law, dividends paid on ordinary shares or ADSs are in principle subject to Dutch dividend withholding tax at a rate of 15% under the Dutch Dividend Withholding Tax Act 1965 (Wet op de dividendbelasting 1965), unless a domestic or treaty exemption or reduction applies. Since January 1, 2024, the Dutch government has introduced an additional withholding tax on dividends paid to related entities in jurisdictions that have a corporate tax rate below 9% or to jurisdictions included on the EU’s blacklist of non-cooperative jurisdictions and in certain abusive situations. The legislative proposal has been published by the Dutch government on March 24, 2021. Pursuant to the proposal, the conditional withholding tax on dividend payments will be an addition to the conditional withholding tax on interest and royalty payments pursuant to the Dutch Withholding Tax Act 2021 (Wet bronbelasting 2021). The rate will be as high as the highest Dutch corporate income tax rate (currently 25.8%) at the time of the dividend payment, which will be the statutory rate applicable to interest and royalty payments to related entities in jurisdictions that have a corporate tax rate below 9% or to jurisdictions included on the EU’s blacklist of non-cooperative jurisdictions, to hybrid entities and in certain abusive situations. At the same time, the current Dutch dividend withholding tax regime is anticipated to remain in place. However, if the dividend withholding tax and the conditional withholding tax on dividends cumulate, the conditional withholding tax will be reduced by the dividend withholding tax levied.
As a result, if the shareholder being a related entity is established in a jurisdiction that has a corporate tax rate below 9% or in a jurisdiction included on the EU’s blacklist of non-cooperative jurisdictions, the tax rate on dividends may rise from 15% to 25.8%.
ADS holders must act through the depositary to exercise their voting rights and, as a result, may be unable to exercise their voting rights on a timely basis.
We will not treat holders of the ADSs (rather than the ordinary shares underlying the ADSs) as shareholders, and they will not be able to exercise shareholder rights, except through our depositary and except that the ADS holders will have meeting rights to attend our general meetings. The depositary will be the holder of the ordinary shares underlying the ADSs, and ADS holders will be able to exercise voting rights with respect to the ordinary shares represented by the ADSs only in accordance with the deposit agreement relating to the ADSs. There are practical limitations on the ability of ADS holders to exercise their voting rights due to the additional procedural steps involved in communicating with these holders. For example, holders of our ordinary shares will be able to exercise their voting rights by either attending the shareholders meeting in person or voting by proxy. ADS holders, by comparison, will not receive any notice directly from us. Instead, in accordance with the deposit agreement, we will use commercially reasonable endeavors to provide at least 30 days’ notice to the depositary of any such shareholders’ meeting and details concerning the matters to be voted on in advance of the meeting date. If we so instruct, the depositary will distribute to ADS holders the notice of the meeting and a statement as to the manner in which voting instructions may be given, or deemed given in accordance with the deposit agreement by holders as soon as practicable after receiving notice from us of any such meeting. To exercise their voting rights, ADS holders must then instruct the depositary as to voting the ordinary shares represented by their ADSs. Due to these procedural steps involving the depositary, the process for exercising voting rights may take longer for ADS holders than for holders of ordinary shares. The ordinary shares represented by ADSs for which the depositary fails to receive timely voting instructions will not be voted.
The trading of our ordinary shares on Euronext Amsterdam and of our ADSs on the Nasdaq may adversely affect the liquidity and value of our ADSs.
Our ordinary shares are traded on Euronext Amsterdam, our ADSs have been approved for listing on the Nasdaq. We cannot predict the effect of this listing on the value of our ordinary shares and ADSs. However, these arrangements may dilute the liquidity of these securities in one or more markets and may adversely affect the development of an active trading market for the ADSs in the United States or the ordinary shares on Euronext Amsterdam. The price of our ADSs could also be adversely affected by trading in our ordinary shares on Euronext Amsterdam and the price of our ordinary shares traded on Euronext Amsterdam could be adversely affected by trading in ADSs on the Nasdaq. The speed by which ADSs can be exchanged for ordinary shares and subsequently traded on Euronext Amsterdam and vice versa might cause differences between the market price for an ADS and the market price for an ordinary share. Additionally, our ordinary shares are quoted in Euros on Euronext Amsterdam, and the ADSs are quoted in U.S. dollars on Nasdaq. Movements in the Euro-U.S. dollar exchange rate may adversely affect the U.S. dollar price of the ADSs on Nasdaq or the Euro price on Euronext Amsterdam. For example, if the Euro weakens against the U.S. dollar, the U.S. dollar price of the ADSs could decline, even if the price of our ordinary shares in Euros increases or remains unchanged. Investors might arbitrate between stock exchanges to exploit such differences, exacerbating potential volatility in our market price.
ADS holders may have difficulty in effecting service of process on our Company and certain directors or officers in the United States in enforcing U.S. judgments in The Netherlands or in enforcing U.S. securities laws in Dutch courts.
We are incorporated and located outside the United States and certain of our directors and officers are located outside of the United States. As a result, it may not be possible for ADS holders to effect service of process within the United States upon all such persons or our Company, or to obtain discovery of relevant documents and/or the testimony of witnesses. ADS holders based in the United States may also have difficulty enforcing in courts outside the United States judgments obtained in U.S. courts against our Company or our directors (including actions under the civil liability provisions of the U.S. securities laws). ADS holders may also have difficulty enforcing liabilities under the U.S. securities laws in legal actions originally brought in jurisdictions located outside the United States.
ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable results to the plaintiff(s) in any such action.
The deposit agreement governing our ADSs provides that owners and holders of ADSs irrevocably waive the right to a trial by jury in any legal proceeding arising out of or relating to the deposit agreement or the ADSs, including claims under U.S. federal securities laws, against us or the depositary to the fullest extent permitted by applicable law. As the waiver relates to claims arising as a matter of contract in relation to the ADSs, we believe that, as a matter of construction of the clause, the waiver would likely to continue to apply to ADS holders who withdraw the ordinary shares represented by the ADSs from the ADS facility with respect to claims arising before the withdrawal, and the waiver would most likely not apply to ADS holders who subsequently withdraw the ordinary shares represented by ADSs from the ADS facility with respect to claims arising after the withdrawal. However, to our knowledge, the enforceability of a contractual pre-dispute jury trial waiver in connection with claims arising under the federal securities laws has not been finally adjudicated by the United States Supreme Court. If this jury trial waiver provision is prohibited by applicable law, an action could nevertheless proceed under the terms of the deposit agreement with a jury trial. Although we are not aware of a specific federal decision that addresses the enforceability of a jury trial waiver in the context of U.S. federal securities laws, it is our understanding that jury trial waivers are generally enforceable. Moreover, insofar as the deposit agreement is governed by the laws of the State of New York, New York laws similarly recognize the validity of jury trial waivers in appropriate circumstances. In determining whether to enforce a jury trial waiver provision, New York courts and federal courts will consider whether the visibility of the jury trial waiver provision within the agreement is sufficiently prominent such that a party has knowingly waived any right to trial by jury. We believe that this is the case with respect to the deposit agreement and the ADSs.
In addition, New York courts will not enforce a jury trial waiver provision in order to bar a viable set off or counterclaim of fraud or one which is based upon a creditor’s negligence in failing to liquidate collateral upon a guarantor’s demand, or in the case of an intentional tort claim (as opposed to a contract dispute). No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary of compliance with any provision of U.S. federal securities laws and the rules and regulations promulgated thereunder.
If any owner or holder of the ADSs, including purchasers of ADSs in secondary market transactions, brings a claim against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, including claims under U.S. federal securities laws, such owner or holder may incur increased costs of bringing a claim and may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against us or the depositary. Any legal suit, action or proceeding against or involving us brought by the depositary or any holder or beneficial owner of ADSs, arising out of or based upon the deposit agreement, the ADSs, the American Depositary Receipts, or ADRs, or the transactions contemplated therein or thereby, may be instituted only in any state or federal court in New York, New York. Any legal suit, action or proceeding against or involving the depositary brought by us, arising out of or based upon the deposit agreement, the ADSs, the ADRs or the transactions contemplated therein or thereby, may only be instituted in a state or federal court in New York, New York.
ADS holders may be subject to limitations on transfer of the ADSs.
The ADSs are only transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary deem it advisable to do so because of any requirement of law or of any government or governmental body, or under any provision of the deposit agreement, or for any other reason.
We cannot assure you that we will not be a passive foreign investment company, or PFIC, for U.S. federal income tax purposes for any taxable year, which could result in adverse U.S. federal income tax consequences to holders of our ordinary shares or ADSs.
A non-U.S. corporation will be a Passive Foreign Investment Company, or PFIC, for any taxable year if either (i) at least 75% of its gross income for such year consists of certain types of “passive” income or (ii) at least 50% of the value of its assets (generally based on an average of the quarterly values of the assets) during such year is attributable to assets that produce passive income or are held for the production of passive income. If we are a PFIC for any taxable year during which a U.S. Holder (as defined in “Material Income Tax Considerations - Material U.S. Federal Income Tax Considerations”) holds our ordinary shares or ADSs, the U.S. Holder may be subject to adverse tax consequences, including (1) the treatment of all or a portion of any gain on disposition as ordinary income, (2) the application of an interest charge with respect to such gain and certain dividends and (3) compliance with certain reporting requirements. Based on our estimated income, assets and market capitalization for 2024, we anticipate we will likely not be a PFIC for 2024. However, whether we are treated as a PFIC is a factual determination that must be made on an annual basis after the close of each taxable year. This determination will depend on, among other things, the ownership and the composition of our income and assets, as well as the value of our assets (which may fluctuate with our market capitalization) and our subsidiaries’ assets from time to time. The United States Internal Revenue Service, or IRS, or a court may disagree with our expectations. Therefore, we cannot assure you that we will not be a PFIC for the current taxable year or for any future taxable year.
If a United States person is treated as owning at least 10% of the value or voting power of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.
Depending upon the aggregate value and voting power of our ordinary shares that United States persons are treated as owning (directly, indirectly or constructively), we could be treated as a controlled foreign corporation, or CFC. Additionally, because our group includes one or more U.S. subsidiaries, certain of our non-U.S. subsidiaries could be treated as CFCs, regardless of whether or not we are treated as a CFC. If a United States person (as defined in the United States Internal Revenue Code of 1986, as amended, or the Code) is treated as owning (directly, indirectly or constructively) at least 10% of the value or voting power of our shares, such person may be treated as a “United States shareholder” with respect to each CFC in our group (if any), which may subject such person to adverse U.S. federal income tax consequences. Specifically, a United States shareholder of a CFC may be required to report annually and include in its U.S. taxable income its pro rata share of each CFC’s “Subpart F income,” “global intangible low-taxed income” and certain investments of earnings in “United States property” by CFCs, whether or not we make any distributions of profits or income of a CFC to such United States shareholder. If you are treated as a United States shareholder of a CFC, failure to comply with these reporting obligations may subject you to significant monetary penalties and may prevent the statute of limitations with respect to your U.S. federal income tax return for the year for which reporting was due from starting. Additionally, a non-corporate U.S. shareholder would generally be denied certain tax deductions or foreign tax credits in respect of its income that may otherwise be allowable to a United States shareholder that is a U.S. corporation. We cannot provide any assurances that we will assist holders of our ordinary shares in determining whether we or any of our non-U.S. subsidiaries are treated as CFCs or whether any holder of our ordinary shares is treated as a United States shareholder with respect to any such CFC, nor do we expect to furnish to any United States shareholders information that may be necessary to comply with the aforementioned reporting and tax paying obligations. The Internal Revenue Service, or IRS, has provided limited guidance on situations in which investors may rely on publicly available information to comply with their reporting and taxpaying obligations with respect to foreign-controlled CFCs. U.S. holders of our ordinary shares should consult their advisors regarding the potential application of these rules to their investment in our ordinary shares.
Item 4. Information on the Company.
A. History and Development of the Company
We were incorporated as a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) under the laws of The Netherlands on November 11, 1988 under the name GENFARM B.V. On May 29, 1997, the Company was converted from a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) into a public company (naamloze vennootschap) named Pharming Holding N.V. Effective July 2, 1998, Pharming Holding N.V. was renamed Pharming Group N.V.
We are registered with the Dutch Chamber of Commerce under number 28048592. Our ordinary shares are traded on Euronext Amsterdam under the symbol “PHARM”. As of December 22, 2020, our ADSs were admitted for listing on the Nasdaq under the symbol “PHAR” and began trading on Nasdaq Global Market.
The address of our registered office is Darwinweg 24, 2333 CR Leiden, The Netherlands. The telephone number of the registered office is +31 (0)71 5247 400. Our agent for service of process in the United States is Pharming Healthcare Inc. The Pharming Healthcare Inc. office is located at 10 Independence Blvd, Suite 401, Warren, New Jersey 07059. The telephone number is +1 908 524 0888.
Our actual capital expenditures for the years ended December 31, 2023, 2022 and 2021 amounted to $1.4 million, $1.4 million and $10.7 million, respectively. Our capital expenditures primarily consist of property, plant and equipment, such as investments in new machinery and equipment in The Netherlands.
We maintain a website at www.pharming.com. The reference to our website is an inactive textual reference only and the information contained in, or that can be accessed through, our website is not a part of this Annual Report. The SEC maintains an Internet site that contains reports and other information that we file electronically with the SEC at http://www.sec.gov.
B. Business Overview
Overview
We are a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines to serve the unserved rare disease patient.
Our first commercialized product, RUCONEST®, is the first and only recombinant C1 esterase inhibitor, or rhC1INH, protein replacement therapy. It is approved for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema, or HAE. RUCONEST® is commercialized in the United States, the European Economic Area, and the United Kingdom through our own sales and marketing organization, and in the rest of the world through our distribution network.
Our second commercialized product, Joenja® (leniolisib), is a small molecule kinase inhibitor that was licensed from Novartis International Pharmaceutical AG, or Novartis, in 2019. Joenja® received FDA approval on March 24, 2023 for the treatment of activated phosphoinositide 3-kinase delta, or PI3Kδ, syndrome, or APDS, in adult and pediatric patients 12 years and older. Joenja® is commercialized in the United States through our own sales and marketing organization.
We have filed for regulatory approval of leniolisib for APDS in additional key markets and have ongoing clinical trials to support regulatory filings for approval in Japan and for pediatric label expansion.
In the European Economic Area, we are working closely with the Committee for Human Medicinal Products, or CHMP, to address the remaining outstanding issues and we are awaiting CHMP's opinion on the leniolisib MAA. In the United Kingdom, we submitted an MAA for leniolisib for APDS patients ages 12 and older under the International Recognition Procedure, or IRP, on the basis of the FDA approval on March 12, 2024.
We are also developing leniolisib for additional primary immunodeficiencies, or PIDs, with greater prevalence than APDS.
OTL-105, an investigational gene therapy for the treatment of HAE, is in preclinical development.
We are headquartered in Leiden, the Netherlands with our U.S. headquarters located in Warren, New Jersey. We are dually listed on the Euronext Amsterdam (PHARM) and Nasdaq Global Select (PHAR) exchanges.
To further build out our rare disease portfolio, we continue to pursue a strategy focused on the in-licensing or acquisition of clinical-stage assets.
Our Portfolio
The following chart summarizes the status of our commercialized product and development program portfolio:
RUCONEST® approved for the treatment of acute attacks in adult and adolescent patients with HAE
Our lead product, RUCONEST® is the first and only recombinant C1 inhibitor protein replacement therapy that is approved for the treatment of acute attacks in adult and adolescent patients with HAE.
HAE is a serious, debilitating, and potentially life-threatening disease. HAE is a rare genetic condition that occurs in between approximately 1 in 10,000 and 1 in 50,000 people worldwide.
In its most common forms, HAE is caused by a functional deficiency of a plasma protein called C1INH. The patients’ C1INH deficiency leads to the uncontrolled activation of the complement cascade, resulting in the over-production of some mediators, leading to the leaking of fluid from blood vessels to the tissue space. The most common symptoms of an HAE attack are caused by overproduction of the bradykinin initiator protein, kallikrein, and thus excessive leakage of fluid into tissue spaces (edema or swelling). Patients may suffer bouts of excruciating abdominal pain, nausea and vomiting that is exacerbated by swelling in the intestinal wall.
Airway, or laryngeal, swelling is particularly dangerous and can lead to death by asphyxiation. Untreated, attacks can last for several days.
The approach to treatment has been initially focused on replacing the missing protein with exogenous C1INH, either collected from pooled plasma or derived recombinantly. More recently, with greater understanding of the pathogenesis, treatments have been developed to block the patients’ contact system.
RUCONEST® has been shown to normalize C1INH activity levels to normal and has been shown to be clinically relevant in HAE attack treatment. The standard posology for the treatment of HAE attacks is 50 units per kilogram of the reconstituted product. RUCONEST® is administered through a slow intravenous, or IV, injection. One vial contains 2100 U of lyophilized product to be reconstituted with 14ml of water for injection. RUCONEST® irreversibly binds to several target molecules, including, importantly the coagulation factor FXII and the protease kallikrein, which (when unbound) cleaves a plasma protein into bradykinin and other products. By binding to and chemically deactivating these molecules, RUCONEST® stops the production of bradykinin and all other mediators and thereby stops the HAE attack.
We currently market RUCONEST® in the United States, the United Kingdom and the European Economic Area through our own sales force. We have various access programs designed to ensure that physicians can request RUCONEST® on behalf of individual patients, who meet the eligibility criteria and receive local health authority approval, in certain countries where RUCONEST® is not commercially available. For a breakdown of total revenues by categories of geographic market for each of the last three financial years, see “Item 5—A. Operating Result.” of this Annual Report.
Joenja® (leniolisib) for the treatment of APDS
We announced the FDA approval of Joenja® (leniolisib) on March 24, 2023 as the first and only treatment indicated for the treatment of adults and adolescents aged 12 years and older with APDS, a rare primary immunodeficiency.
Discovered in 2013, APDS is a genetic condition which affects approximately 1.5 people per million globally. It is a clinically heterogenous disease that can lead to end-organ damage and early mortality. APDS is a progressive primary immunodeficiency and regulatory disorder characterized by severe, recurrent sinopulmonary infections; persistent, severe, or recurrent herpesvirus infections, particularly Epstein-Barr virus, or EBV, and Cytomegalovirus, or CMV; lymphadenopathy, hepatomegaly, splenomegaly, and/or nodular lymphoid hyperplasia; autoimmune cytopenias; enteropathy; bronchiectasis; possible malignancy, especially lymphoma; and dysregulated B and T cell function.
Although awareness of APDS has increased since its discovery in 2013, the disease may still be misdiagnosed in patients not seen by a specialist. Increased education among physicians is needed to aid early diagnosis and accurate treatment. Diagnostic delay may lead to an accumulation of damage over time, including bronchiectasis. APDS patients also have a significant risk of developing lymphoma due to the unchecked lymphoproliferation. Management of APDS frequently includes treatment such as prophylactic antibiotics, immunoglobulin replacement, immunosuppression, chemotherapy for lymphoma, or stem cell transplantation. Many of these drugs can cause serious side effects and transplant has significant morbidity and mortality. Patients with APDS have been reported to experience early mortality with their survival probability being up to 28% lower than the global population. Lymphoma has been reported to be the leading cause of death in patients with APDS (24%), followed by infections (17%).
Joenja® (leniolisib) is an oral small molecule PI3Kẟ inhibitor approved in the U.S. Joenja® inhibits the production of phosphatidylinositol-3-4-5-trisphosphate, which serves as an important cellular messenger and regulates a multitude of cell functions such as proliferation, differentiation, cytokine production, cell survival, angiogenesis, and metabolism. Results from a randomized, placebo-controlled Phase II/III clinical trial demonstrated clinical efficacy of Joenja® in the coprimary endpoints; demonstrating statistically significant impact on immune dysregulation and normalization of immunophenotype within these patients, and interim open label extension data has supported the safety and tolerability of long-term Joenja® administration. Leniolisib is also being evaluated in two Phase III clinical trials in children with APDS and a Phase III clinical trial is ongoing in Japan in adult and pediatric patients 12 years of age and older with APDS.
Clinical studies
In partnership with Novartis, Pharming studied leniolisib to assess the efficacy and safety of leniolisib in patients with APDS. The study, a Phase II/III potentially registration enabling study was composed of two sequential parts. The first part included six patients in an open-label dose escalation study designed to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of leniolisib.
The first part of the study showed that oral leniolisib led to a dose-dependent reduction in PI3K/AKT pathway activity assessed ex-vivo and improved immune dysregulation. We observed normalization of circulating transitional and naive B-cells, reduction in PD-11CD41 and senescent CD571CD42 T cells and decreases in elevated serum immunoglobulin M and inflammatory markers including interferon g, tumor necrosis factor, CXCL13, and CXCL10. After 12 weeks of treatment, all patients showed amelioration of lymphoproliferation with lymph node sizes and spleen volumes reduced by 39% (mean; range, 26%-57%) and 40% (mean; range, 13%- 65%), respectively. Leniolisib was well tolerated and improved laboratory and clinical parameters in APDS, supporting the specific inhibition of PI3Kδ as a potential therapy in APDS and other diseases characterized by over-activation of the PI3Kδ pathway.
The second part was a randomized, blinded, placebo-controlled study, which enrolled 31 patients with APDS who were 12 years of age or older. Patients were randomized 2:1 to receive either leniolisib 70 mg twice daily or placebo for 12 weeks. Following this, patients were permitted to rollover to an open-label extension study to evaluate long-term safety, tolerability, and efficacy. Primary outcome measures were differences from baseline in lymph node size and in percentage of naïve B cells in peripheral blood, assessed as proxies for immune dysregulation and deficiency.
The primary efficacy results demonstrated clinical efficacy of leniolisib over placebo with a statistically significant reduction in the size of the lymph nodes (p=0.0006) and normalization of immune dysfunction, as evidenced by increased proportion of naïve B cells (p=0.0002). Key secondary evaluations were supportive, including patient and physician global assessment tools which showed increased well-being and less disease activity, respectively, of patients randomized to leniolisib as compared to placebo.
In the study, leniolisib was generally well-tolerated. The majority of reported adverse events in both treatment groups were classified as mild. There were no adverse events that led to discontinuation of study treatment, there were no deaths, and the incidence of serious adverse events, or SAEs, was lower in the leniolisib group than the placebo group. None of the SAEs were suspected to be related to study treatment.
The ongoing open-label extension, or OLE, study includes 37 patients with APDS aged 12 years or older who, at the time of data cutoff for the interim analysis, had received 70 mg of the selective PI3Kδ inhibitor leniolisib twice a day for at least 25 weeks; 66% were exposed for 96 weeks or longer, with a median duration on study therapy of approximately two years; four patients had more than five years exposure. The OLE study was primarily designed to assess the safety and tolerability of long-term leniolisib treatment in adolescent and adult patients with APDS who previously participated in a Phase II/III leniolisib study. The OLE study’s secondary endpoints are intended to evaluate the efficacy and pharmacokinetics of long-term leniolisib treatment in these patients.
The interim analysis found that leniolisib was well tolerated to this point in the OLE study. It also indicated the durability of the efficacy results seen in the randomized, controlled trial, which showed significant improvement over placebo in the co-primary endpoints of reduction in lymph node size and increase in naïve B cells.
The majority of adverse events, or AEs, reported in the interim analysis were grades 1 and 2, and included upper respiratory tract infection, headache and pyrexia. Grade 1 AEs are the least severe and grade 5 the most severe. Overall, 13.5% of AEs were study drug-related; these affected five patients and included weight gain (n=3), arthralgia (n=1), hyperglycemia (n=1), and decreased neutrophil count (n=1). Of all AEs assessed in the analysis, 16.2% were classified as serious, but none of these were identified as related to study treatment. There was one death among study participants which was identified as not related to study treatment.
Among study participants, some experienced reductions in APDS disease markers, with levels of response varying between individuals. Responses included:
• reduced lymphadenopathy, splenomegaly, and IgM levels; • improved or resolved anemia, thrombocytopenia, and lymphopenia; and
• resolved neutropenia in all affected patients.
Two post-hoc analyses were performed to assess infection rates and immunoglobin replacement therapy, or IRT, usage. 37% of participants who were on IRT were able to reduce their IRT use while taking leniolisib. Six patients became IRT-independent, with four of those patients having been IRT-independent for one to two-and-a-half years at the data cutoff. The median time to IRT reduction was 12.1 months and the median time to IRT discontinuation was 11.9 months. IRT use was captured by the investigator as concomitant medication at each study visit per protocol. IRT utilization was not prespecified as an endpoint or analysis and is observational only; no determination of statistical significance can be made and no conclusions should be drawn.
Patients on leniolisib were also observed to have a reduction in the number of infection days. This decrease in annualized infection rates was accompanied by no appreciable increase in antibiotic use despite the reduction in IRT utilization. Although safety was the primary objective of the OLE study, this post hoc analysis was not powered to provide any statistical significance of efficacy and therefore no conclusions should be drawn.
APDS patient finding
On March 2, 2021, we announced the launch of a sponsored genetic testing program, “navigateAPDS”, designed to assist clinicians in identifying patients and their family members with APDS, which may lead to earlier diagnosis. A genetic test enables a clinician to confirm their clinical suspicions and definitively diagnose APDS.
Our support of the navigateAPDS program will continue to facilitate genetic testing and counselling for eligible individuals in the United States and Canada at no charge. The navigateAPDS program offers testing with comprehensive immunodeficiency panels, providing critical information on potential genetic causes of immunodeficiencies and dysregulation that a patient may have. In addition to providing genetic testing to individuals who may present with a clinical picture known to be associated with APDS, navigateAPDS offers pre-test and post-test genetic counseling through a third party, and all blood relatives of patients found to have a positive molecular diagnosis of APDS are qualified for familial variant testing through the program. By offering this testing, physicians and patients are able to better understand the genetic underpinnings of their disease and manage their condition more precisely.
In Europe, we are intensifying our patient identification efforts together with leading immunology centers of excellence treating patients with APDS and other rare immune deficiencies.
Based on available literature, we estimate APDS prevalence to be 1.5 patients per million. Our U.S. and global APDS patient finding efforts progressed during the year. As of December 31, 2023, Pharming has identified over 840 diagnosed APDS patients of all ages in global markets, including over 200 patients in the United States. Of the identified patients in the U.S., approximately 75% are 12 years of age or older, the majority of whom are currently eligible for treatment with Joenja®. Over 730 of these patients are in the U.S., Europe, the U.K., Japan, Asia Pacific, Middle East, and Canada, key markets for Pharming with estimated total prevalence of approximately 2,000 APDS patients.
We advanced several initiatives during 2023 to assist in the diagnosis of additional APDS patients, including our sponsored genetic testing program in the U.S. and Canada, partnerships with several genetic testing companies who undertake their own testing efforts and family testing programs. We have initiated a number of programs collaborating with clinicians and patients to aid in reducing the barriers and allowing the appropriate testing in families with APDS, to help identify family members of APDS patients who may also be affected by this disease. APDS is an inherited genetic disease and we believe that many of the over 200 APDS patients already identified in the U.S. are likely to have family members who remain undiagnosed.
Variant of Uncertain Significance, or VUS, resolution
APDS is diagnosed based on clinical symptoms, assessment of immune cell function and genetic testing. For a patient to receive a definitive APDS diagnosis, a genetic test revealing a disease-causing (pathogenic or likely pathogenic) variant in either the PIK3CD or PIK3R1 genes is required. Patients with clinical symptoms compatible with APDS frequently receive inconclusive genetic variant test results, i.e., previously unseen variants in the PIK3CD or PIK3R1 genes. It is important to determine if these VUSs cause APDS.
As of December 31, 2023, Pharming has identified more than 1,100 patients in the U.S. with a number of VUSs in the PIK3CD or PIK3R1 genes and is setting up validation studies with various laboratories to confirm which of these variants should be classified as APDS. As results become available, patients with validated variants could be diagnosed with APDS and, therefore, potentially be eligible for Joenja® treatment. We expect completion of these studies during the fourth quarter of 2024.
Regulatory status
United States
On March 24, 2023 the FDA approved our New Drug Application, or NDA, of Joenja® (leniolisib) for the treatment of patients ages 12 and older with APDS. The FDA evaluated the Joenja® application for APDS under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Joenja® launched in the U.S. in early April 2023.
European Economic Area
In October 2020, we announced that the European Commission had granted orphan drug designation for leniolisib for the treatment of APDS, based on a positive opinion from the Committee for Orphan Medicinal Products, or COMP, of the European Medicines Agency, or EMA.
In January 2022, a positive decision was made by the EMA on the Pediatric Investigation Plan, or PIP, for leniolisib. For the registration of new medicines in Europe, biopharmaceutical companies are required to provide a PIP which outlines the strategy for investigation of a new medicinal product in the pediatric population. The positive PIP opinion from the Pediatric Committee, or the PDCO, is an endorsement of the clinical program to evaluate the safety and efficacy of leniolisib in patients from 1 year of age to less than 18 years of age with APDS.
In August 2022, we announced the leniolisib MAA was granted accelerated assessment by EMA’s CHMP. The accelerated assessment reduces the review timeframe from 210 days to 150 days. Upon request, EMA will grant an accelerated assessment of an MAA if they decide the product is of major interest for public health, and in particular, from the viewpoint of therapeutic innovation.
In October 2022, we submitted an MAA to EMA for leniolisib as a treatment for APDS in adults and adolescents 12 years or older.
The MAA was supported by positive data from a Phase II/III study of leniolisib, announced on February 2, 2022, which met its co-primary endpoints of reduction in lymph node size and increase in percentage of naïve B cells in patients with APDS. Furthermore, safety data from the study showed that leniolisib was well tolerated by participants. Also submitted as part of the MAA were data from a long-term OLE study in patients with APDS treated with leniolisib.
On October 28, 2022, we announced that our MAA for leniolisib had been validated for scientific evaluation under an accelerated assessment by EMA's CHMP.
In February 2023, we announced that the CHMP decided to shift its assessment of the MAA for leniolisib to a standard review timetable. The list of questions we received from the EMA included a request to submit updated data from the ongoing OLE study collected after the interim analysis included in the original MAA.
In May 2023, we submitted our response to the CHMP Day 120 list of questions. Subsequently, as part of the MAA review procedure timetable, we received the CHMP Day 180 list of outstanding issues in July 2023. In August 2023, we announced that considering the rarity of the disease and the unmet need for the treatment of APDS patients, the EMA's CHMP would consult an Ad-hoc Expert Group, or AEG, at a closed meeting also involving our representatives including leniolisib investigators and APDS patients. Under EMA regulations, the CHMP may call an AEG meeting when a medicine is being assessed that requires input from specialized scientific advisors on matters that may fall outside the expertise of the EMA’s established Scientific Advisory Groups, as is typically the case for rare diseases with few experts.
We submitted our response to the CHMP Day 180 list of outstanding issues, or LoOI, in October 2023. In November 2023, we received a Day 180 Second LoOI from the CHMP. The CHMP consulted the AEG at a meeting held at the end of November 2023.
We are working closely with the CHMP to address the remaining outstanding issues and we are now awaiting the CHMP's opinion on the leniolisib MAA.
United Kingdom
In February 2022, the MHRA granted Promising Innovative Medicine, or PIM, designation to leniolisib for the treatment of APDS. A PIM designation is an early indication that leniolisib is a candidate for the MHRA’s Early Access to Medicines Scheme. This scheme provides an opportunity for treatment options to be used in clinical practice in parallel with the later stages of the regulatory process.
In November 2023, we announced our intention to file an MAA with the MHRA for APDS patients ages 12 and older, through the IRP which replaced the European Commission Decision Recognition Procedure, or ECDRP, beginning January 1, 2024. The IRP allows a company to submit an MAA for a product on an abbreviated review timeline if the same product has already received a marketing authorization from one of the MHRA’s specified reference regulators, or RRs, including the EMA and the FDA.
We submitted an MAA for leniolisib under the IRP on the basis of the FDA approval on March 12, 2024. The MHRA has 110 days with an option to enforce a 60 day clock stop, if needed, from the date the IRP submission is validated, to review and issue its decision.
Canada, Australia, and Israel
Pharming filed regulatory submissions for APDS patients ages 12 and older in Canada and Australia in the third quarter of 2023, and Israel in the second quarter. These submissions are progressing as expected and we anticipate regulatory action in 2024 for Canada, Australia, and Israel.
Market access
We currently market Joenja® (leniolisib) for the treatment of APDS in adults and adolescents 12 years of age and older in the United States. We have named patient and expanded access programs designed to ensure that physicians can request leniolisib on behalf of individual patients living with APDS, who meet the eligibility criteria and receive local health authority approval, in certain countries where leniolisib is not commercially available.
Pipeline development
Japan clinical trial
In May 2023, the Ministry of Health, Labour and Welfare of Japan, or MHLW, granted leniolisib orphan drug designation, or ODD, for the treatment of APDS. In August 2023, the first patient was enrolled in a Phase III clinical trial in Japan evaluating leniolisib for the treatment of APDS in adult and pediatric patients 12 years of age and older. Patient enrollment in this study is now complete.
The single-arm, open-label clinical trial will evaluate the safety, tolerability, and efficacy of leniolisib in three patients, 12 years of age and older, who have a confirmed APDS diagnosis. Each patient will receive weight-based dosing up to 70 mg of leniolisib twice daily for 12 weeks. The study’s primary efficacy endpoints and secondary endpoints mirror those used to evaluate the clinical outcomes in each of the earlier leniolisib APDS trials.
We plan to file an application for the approval of leniolisib with Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, following completion of the appropriate clinical trials. An approval decision would be expected in nine months based on priority review of the application due to ODD. Eligible patients enrolled in the trial will continue to receive the investigational drug for at least an additional year through an open-label extension trial.
Pediatric clinical trials
We have developed a clinical plan to include children as young as one year of age. During the first half of 2022, we received positive decisions from the EMA and MHRA on the PIP for leniolisib as a treatment for APDS in children. The leniolisib PIP includes two planned, global clinical trials in pediatric patients with APDS aged 4 to 11 years old and aged 1 to 6 years old. These two studies were initiated in 2023 and will support regulatory filings worldwide for pediatric label expansion.
Patients aged 4 to 11 years
This Phase III clinical trial is evaluating the investigational drug leniolisib in children with APDS at sites in the United States, Japan, and the EU.
The single-arm, open-label, multinational clinical trial will evaluate the safety, tolerability, and efficacy of leniolisib in 15 children aged 4 to 11 years who have a confirmed APDS diagnosis. The study's primary efficacy endpoints and secondary endpoints mirror those used to evaluate the clinical outcomes in the previous leniolisib Phase II/III APDS trials for patients aged 12 and older.
The first patient was enrolled in February 2023 and we are nearing completion of enrollment in the clinical trial.
Patients aged 1 to 6 years
This Phase III pediatric clinical trial is evaluating a new pediatric formulation of the investigational drug leniolisib in children with APDS at sites in the United States, Japan, and the EU.
The single-arm, open-label, multinational clinical trial will evaluate the safety, tolerability, and efficacy of leniolisib in 15 children aged 1 to 6 years of age who have a confirmed APDS diagnosis. These patients will receive a specific, pediatric granulated formulation of leniolisib. The study’s primary efficacy endpoints and secondary endpoints mirror those used to evaluate the clinical outcomes in the previous leniolisib Phase II/III APDS trials for patients aged 12 and older.
The first patient was dosed in November 2023 and enrollment in the study is continuing as planned.
Additional indications (PI3Kδ platform)
PIDs beyond APDS
As we continue to work towards regulatory approvals of leniolisib for APDS in additional geographies and pediatric label expansion, we have also commenced work to identify and prioritize other indications where leniolisib has the potential to deliver value for patients. PI3Kδ has been identified as an important player in a variety of disease states, and leniolisib has demonstrated an attractive, long-term efficacy, safety and tolerability profile in clinical trials conducted in both healthy volunteers and APDS patients. This provides a solid basis for our plans for the investigation and investment in further leniolisib indications.
PIDs with immune dysregulation
In December 2023, Pharming announced the expansion of its rare disease pipeline with plans to develop leniolisib for additional PIDs with greater prevalence than APDS. Pharming has engaged with and received feedback from the FDA on its plans to develop leniolisib for PID disorders with immune dysregulation.
Leniolisib, by reducing PI3Kδ activity, could help rebalance immune dysregulation in PIDs, positively impacting clinical manifestations including lymphoproliferation and autoimmunity. Based on Pharming's APDS experience, leniolisib has potential to be an effective and tolerable chronic treatment approach for PIDs with immune dysregulation linked to PI3Kδ signaling.
Pharming is now in the final stages of preparation for the start of an initial Phase II, proof of concept, clinical trial in targeted PID genetic disorders with immune dysregulation linked to PI3Kẟ signaling in lymphocytes, with similar clinical phenotypes and unmet medical need to APDS. These PID disorders include ALPS-FAS, CTLA4 haploinsufficiency and PTEN deficiency.
The epidemiology of these targeted PID genetic disorders suggests a prevalence of approximately five patients per million.
The Phase II clinical trial is a single arm, open-label, dose range-finding study to be conducted in approximately 12 patients. The objectives for the trial will be to assess safety and tolerability, pharmacokinetics, pharmacodynamics, and explore clinical efficacy of leniolisib in this new PID population. The trial has been designed to inform a subsequent Phase III program.
The Phase II clinical trial will be conducted at the National Institute of Allergy and Infectious Diseases, NIAID – part of the National Institutes of Health, or NIH – with lead investigator Gulbu Uzel, M.D., Senior Research Physician, and co-investigator V. Koneti Rao, M.D., FRCPA, Senior Research Physician, Primary Immune Deficiency Clinic (ALPS Clinic).
Pre-clinical pipeline
OTL-105
In 2021, we entered into a license agreement with Orchard to research, develop, manufacture and commercialize OTL-105, an ex-vivo autologous gene therapy for the treatment of patients with HAE due to a deficiency of C1INH. This novel approach has the potential of being curative, allowing HAE patients to live a normal life, without being dependent on acute or prophylactic use of HAE medication.
OTL-105 is based on Orchard’s ex-vivo autologous gene therapy platform approach which is designed to use the HAE patients’ own blood stem cells and insert those cells into a working copy of the gene that is reduced in HAE. In pre-clinical proof of concept studies, gene-corrected stem cells produced relevant active C1-esterase inhibitor.
Preclinical development of OTL-105 continued during 2023 including work towards the preparation of preclinical proof of concept studies.
On January 24, 2024, Kyowa Kirin Co., Ltd., a Japan-based global specialty pharmaceutical company, completed an acquisition of Orchard. We are responsible for funding of the OTL-105 program and do not anticipate any negative impact of the acquisition on OTL-105.
Pompe Disease program - discontinued
As announced in our first quarter 2023 results, we decided that, based on our preclinical investigations and evaluations for potential differentiating features of Alpha-Glucosidase, for the treatment of Pompe Disease, we would discontinue further development of this asset.
Manufacturing
RUCONEST®
Our proprietary transgenic manufacturing technology platform is the foundation upon which we have built our Company. We have developed a unique, scalable, reproducible, current Good Manufacturing Practices, or cGMP, validated methodology for the production of high-quality recombinant human proteins. Our manufacturing process utilizes transgenic animals to produce human recombinant proteins in their milk. This process enables the production of the protein in the milk of the animals without the animals suffering or being altered in other aspects of their biology.
Once the rabbit lines are produced, we raise them at specialized facilities with high standards of animal husbandry, welfare and security. These facilities further incorporate protections against contamination from the outside environment. Special attention is given to strict identification and segregation of transgenic and non-transgenic materials and animals. Moreover, our Company also follows strict pharmaceutical procedures to prevent the prohibited release of transgenic animals, their semen or any other reproductive transgenic material into nature. In these facilities, the consistent and regulated handling of animals is carefully monitored. The resulting milk goes through several stages of cGMP processes. We have multiple “upstream” manufacturing facilities of our own. The “downstream” processes include the purification, involving standard technologies such as various chromatography and filtration steps, followed by formulation and sterile filling into lyophilized powder product in vials ready for reconstitution.
We have entered into manufacturing and supply agreements for RUCONEST® with, among others, Sanofi S.A., or Sanofi, and BioConnection Investments B.V. (formerly BioConnection B.V.), or BioConnection, for these downstream processes, as we do not have a GMP-certified lab capable of performing the quality control procedures necessary for the release of product.
Joenja®
Pursuant to our agreement with Novartis relating to Joenja®, we have agreed to manufacture both the drug substance as well as the drug product via our own Contract Manufacturing Organizations, or CMOs. For the drug substance, Ardena Holding N.V., or Ardena, has been chosen as the CMO. For the film coated tablets, Skyepharma Production SAS, or Skyepharma, has been chosen as the CMO. The 70 mg film coated tablet manufactured by Skyspharma have been launched for patients 12 years of age and older. In addition, two pediatric formulations are also being developed; the first, lower strengths tablets that also will be manufactured at Skyepharma, and the second, film coated granules that are being developed by Almac Group.
As we continue to expand the capacity and range of products, it is uncertain whether and to what extent we will be able to enter into manufacturing partnerships or agreements on a timely basis and on acceptable terms. We have established a contract and supplier relationship management process to facilitate the timely onboarding of new contractors or the expansion of contracts at current contractors. Even if a partnership or agreement has been concluded, the possibility exists that these partners will fail to live up to the agreements made with them or that we are unable to maintain such agreements. A failure to develop and/or sufficiently contract additional manufacturing capacity on a timely basis could have significant consequences for our business, to our financial position, results of operations, prospects and as result may also have a negative effect on the market price of our shares.
Our Strategy
Our vision is to become the leading global rare disease company of choice for patients and partners with a specific focus on transformative medicines in rare diseases. Our mission is to bring the unserved rare disease patients the solutions they need through our fully integrated and ongoing clinical development and commercialization expertise.Our core values enable our mission and create a clear pathway forward to meet our strategic goals and objectives.
We create sustainable long-term value by leveraging our core strengths in clinical development and rare-disease drug commercialization. To sustain longer-term growth, we continue to build a risk-balanced portfolio while taking on more development activities, including life cycle management of leniolisib. This portfolio could include a broad range of acquired and in-licensed clinical stage assets that further build upon our strategy.
Moreover, we have made progress on our strategy to move from revenue dependency on one product in one geography, to a company with multiple commercialized products in multiple geographies generating revenues across key markets.
For leniolisib, our strategy is to make the drug available in key markets including the United States, Europe, U.K., Japan, Asia Pacific, Middle East and Canada.
Competition
The life sciences industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. We face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions. Any product candidates that we successfully develop and commercialize will compete with existing products and new products that may become available in the future. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical study sites and patient registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs.
Companies that complete clinical trials, obtain required health authority approvals and commence commercial sale of their drugs before their competitors may achieve a significant competitive advantage, and our commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop and commercialize. Our competitors may also obtain FDA, European Commission, or other regulatory approval for their products more rapidly than we obtain approval, which could result in our competitors establishing a strong market position for either the product or a specific indication before we are able to enter the market. Drugs resulting from our research and development efforts or from our joint efforts with collaboration partners therefore may not be commercially competitive with our competitors’ existing products or products under development.
We anticipate that we will face increasing competition as new products and therapies enter the market and advanced technologies become available in both the HAE space and relating to upcoming pipeline projects. We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, delivery, patient convenience, price and the availability of reimbursement from government and other third-party payors.
Competition in HAE
In the core U.S. market for RUCONEST®, there are four approved therapies available to treat acute HAE attacks and an additional four therapies for attack prevention. These therapies have transformed the lives of HAE patients. The early years of treatment focused on limiting the consequences of attacks, and very few patients used prophylactic medications. With the improvement of prophylactic therapy, many patients now use this and have had significant benefit.
Nevertheless, patients taking prophylactic medications still experience breakthrough attacks and immediate access to an acute treatment medication is required and recommended in all HAE treatment guidelines. With two of the prophylactic medications (HAEGARDA® and TAKHZYRO®), published data from randomized-controlled studies indicate that approximately 50% of patients still had breakthrough attacks.
Likewise, with the oral prophylactic medication ORLADEYO® showed that 90% of patients had breakthrough attacks in a randomized-controlled clinical trial. Lastly, many patients need to re-dose acute therapies that do not address the underlying C1INH deficiency.
RUCONEST®, a recombinant C1 esterase inhibitor that blocks production of bradykinin, is an option for patients who continue to experience breakthrough attacks while on prophylaxis or for patients who need to re-dose other acute therapies due to relapse of their attacks. As RUCONEST® is intravenously delivered it is immediately and completely bioavailable to stop the progression of an HAE attack.
We consider several companies to be our current and future competitors in the HAE space, including, but not limited to, BioCryst, BioMarin, CSL Behring, Intellia, Ionis, Kalvista, Pharvaris and Takeda. To the extent these companies develop treatments that are more efficacious, less expensive, more convenient or produce fewer side effects, our market opportunity would be reduced.
Leniolisib competition
With regards to competition for leniolisib, we are currently not aware of any active APDS clinical development programs. However, as several programs were halted in early stage of development, these could be re-started at any time and may deliver products that, if efficacious and safe, could compete successfully against leniolisib and may significantly reduce our future market opportunity.
Intellectual Property
Patents
Patents, know-how, trade secrets and other intellectual property rights are important to the success of our business. We use patents and licensing to protect our products and technology and are careful to develop products that don’t infringe on the intellectual property rights of third parties. Currently, we have several patent applications granted and pending in jurisdictions including the United States, Europe and Japan. The patent positions of pharmaceutical companies can be uncertain and may involve complex legal and factual questions.
It is uncertain whether pending patent applications will be successful, that these patents will afford adequate protection and that the existing patents will not be challenged. Failure to obtain patents may result in expensive and protracted proceedings to defend our proprietary rights. The success of our Company also depends, in part, on the ability of our licensors to obtain, maintain and enforce their intellectual property rights to the extent required for us to develop and commercialize our products.
We actively seek to protect the intellectual property and proprietary technology that we believe is important to our business, including seeking, maintaining, enforcing and defending patent rights and protecting know-how for our technology platform and related therapeutics and processes, whether developed internally or licensed to or from third parties. Our success will depend on our ability to obtain and maintain patent and other protections including data/market exclusivity for our product candidates and platform technology, preserve the confidentiality of our know-how and operate without infringing the valid and enforceable patents and proprietary rights of third parties. See “Item 3 – D. Risk Factors – Risks Related to Intellectual Property” of this Annual Report.
Our policy is to seek to protect our proprietary position early, generally by filing an initial priority filing in the European Patent Office. This is followed by the filing of an international patent application under the Patent Cooperation Treaty, or PCT, claiming priority from the initial application(s) and then filing regional and national applications for patent grant in territories including, for example, the United States and Europe. In each case, we determine the strategy and territories required after discussion with our patent attorneys, and, where applicable, collaboration partners so that we obtain relevant coverage in territories that are commercially important to our technologies and product candidates. With respect to our product candidates and related methods that we intend to develop and commercialize in the normal course of business, we will seek patent protection covering formulation, the indicated use, and the method of administration. We may also pursue patent protection with respect to manufacturing and drug development processes when possible. We intend to additionally rely on data exclusivity, market exclusivity, other regulatory exclusivities and patent term extensions when available.
We also rely on trade secrets and know-how relating to our underlying platform technology and product candidates. In each case, we seek to balance the value of patent protection against the advantage of keeping know-how confidential.
Issued patents can provide exclusivity on claimed subject matter for varying periods of time, typically starting on the date of patent grant and expiring at the end of the legal term of a patent in the country in which it is granted. From the date of filing, provisional protection is present to the scope of the later granted claims. In general, patents provide exclusionary rights for 20 years from the filing date of a non-provisional patent application in a particular country, or for a PCT international patent application, from the international filing date, assuming all maintenance fees are paid. In some instances, patent terms may be increased or decreased, depending on the laws and regulations of the country or jurisdiction that grants the patent. In the United States, a patent term may be shortened if a patent is terminally disclaimed over another patent or as a result of delays in patent prosecution by the patentee. A U.S. patent’s term may be lengthened by a patent term adjustment which compensates a patentee for administrative delays by the USPTO in granting a patent. The patent term of a European patent is 20 years from its filing date, which is not subject to patent term adjustments in the same way as U.S. patents. When using a priority filing, the priority year can be added to the patent term of 20 years from the filing; the patent term may thus be 21 years from the priority date.
The level of protection afforded by a patent may vary and depends upon many factors, including the type of patent, the scope of its claim coverage, claim interpretation and patent law in the country or region that granted the patent, the validity and enforceability of the patent under such laws, and the availability of legal remedies in each particular country.
In certain regions or countries, regulatory-related patent extensions may be available to extend the term of a patent that claims a regulatorily approved product or method. Regulatory-based patent term extensions allow patentee to recapture a portion of patent term effectively lost as a result of the regulatory review period for a product candidate. The term of a United States patent that covers an FDA-approved drug or biologic, for example, may be eligible for patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory review process. The Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, permits a patent term extension of up to five years beyond the expiration of the patent. Patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one patent applicable to an approved drug may be extended. Similar provisions are available in Europe, Japan and other jurisdictions to extend the term of a patent that covers an approved drug, for example Supplementary Protection Certificates in Europe. In particular, a maximum of five and a half years of supplementary protection can be achieved in Europe for an active ingredient or combinations of active ingredients of a medicinal product protected by a basic patent, if a valid marketing authorization exists (which must be the first authorization to place the product on the market as a medicinal product) and if the product has not already been the subject of supplementary protection. In the future, if and when our additional products receive FDA approval, we expect to apply for regulatory patent term extensions on patents covering those products. We anticipate that some of our issued patents may be eligible for patent term extensions in certain jurisdictions based on an approved product or method, but such extensions may not be available and therefore its commercial monopoly may be restricted solely to patent term.
RUCONEST® has patent protection in the U.S. and EU until October 7, 2026, as well as biologics reference product exclusivity in the United States expiring July 16, 2026.
As of December 31, 2023, we solely owned 110 granted patents, of which 8 are U.S.-issued, and 12 pending patent applications, of which 2 are U.S. pending patent applications. Commercially or strategically important non-U.S. jurisdictions in which we hold issued or pending patent applications include (in addition to Europe): the United Kingdom, China, Japan, Canada, Israel, Australia and New Zealand. We also have exclusive license to 161 patents and patent applications from Novartis related to leniolisib.
Our granted patents and pending patent applications include the making of C1INH in the milk of transgenic mammals. In addition, our pending patent applications also include claims for the use of C1INH in PE.
Pharming expects to have patent protection for leniolisib in APDS under the Novartis composition of matter patent (U.S. Patent No. 8,653,092, EU patent EP259094B1) through July 2036 in the U.S. and EU, which we anticipate may be extended to January 2037 if we obtain a pediatric extension.
The USPTO adjusted the expiration when the patent was granted to account for delays in the approval of the patent, and an extension was applied for shortly after the FDA approved Joenja® (leniolisib). Similarly, in the E.U., a supplemental protection certificate will be applied for shortly after approval in the E.U. It is these extensions which we anticipate will result in the 2036 expiration.
In the European Economic Area, upon successful completion of the agreed PIP, leniolisib would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval as result of its EU Orphan Drug Designation. Thus, we anticipate that the patent protection will extend beyond the marketing exclusivity.
Trademarks
We currently have registered trademarks in the EU, the United States and key international markets we intend to focus on for our Company name “Pharming” with the associated logo, “RUCONEST®” with its associated logo, as well as for Joenja® and its associated logo. We have obtained trademark protection for other marks, including ones for patient support services associated with our products. With the assistance of outside counsel we regularly assess which marks we should register and where, and we have effective systems to ensure that renewals are timely filed. We also maintain watch services and ensure that our marks are not being infringed internationally.
Government Regulation and Product Approval
United States
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and non-U.S. statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the drug development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve a pending New Drug Application, or NDA, or Biologics License Application, or BLA, withdrawal of an approval, imposition of a clinical hold, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
The process required by the FDA before a drug may be marketed in the United States generally involves:
•completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;
•submission to the FDA of an IND, which must become effective before human clinical trials may begin;
•approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated;
•performance of adequate and well-controlled clinical trials, in accordance with good clinical practice, or GCP, requirements to establish the safety and efficacy of the proposed drug for each indication;
•payment of user fees,if applicable;
•submission to the FDA of a registration filing (i.e., NDA or BLA);
•satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements, and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;
•satisfactory completion of an FDA inspection of selected clinical sites to assure compliance with GCPs and the integrity of the clinical data;
•satisfactory completion of an FDA advisory committee review; if applicable, and
•FDA review and approval of the registration filing.
Preclinical Studies
Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy. An IND Sponsor must submit the results of the nonclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND. Some nonclinical testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND Sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.
Clinical Trials
Clinical trials involve the administration of the investigational new drug or biologic to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must continue to oversee the clinical trial while it is being conducted. Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined. In Phase I, the drug or biologic is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an initial indication of its effectiveness. In Phase II, the drug or biologic is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. In Phase III, the drug or biologic is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the safety and efficacy of the product for registration approval, to establish the overall risk-benefit profile of the product and to provide adequate information for the labeling of the product.
Progress reports detailing the results of the clinical trials must be submitted, at least annually, to the FDA, and more frequently if SAEs occur. Phase I, Phase II and Phase III clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the Sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements, or if the drug has been associated with unexpected serious harm to patients.
Drugs or biologics used in clinical trials must be manufactured in accordance with cGMP.
During the development of a product, the FDA provides the opportunity for dialogue and guidance on the development program. There are several categories of formal meetings which are dependent upon the stage of development, and the product type. Advice from the FDA is typically provided based on questions concerning, for example, quality (chemistry, manufacturing and controls testing), nonclinical testing and clinical studies. Such advice is not legally binding with regard to any future registration applications of the product concerned however is helpful in product development and understanding FDA expectations.
Marketing Approval
Assuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture and controls, and proposed labeling, among other things, are submitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA or BLA is subject to a substantial application user fee. Under the PDUFA, guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA or BLA for a new molecular entity or biological entity, respectively, and to review and act on the submission of such. This review typically takes twelve months from the date the NDA or BLA is submitted to the FDA because the FDA has approximately two months to make a “filing” decision.
The FDA also may require submission of a risk evaluation and mitigation strategy, or REMS, plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools.
The FDA conducts a preliminary filing review of all NDAs or BLAs within the first 60 days after submission, before accepting them, to determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA or BLA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA or BLA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, quality and purity.
The FDA may refer an application to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Before approving an NDA or BLA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and are adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA or BLA, the FDA will typically inspect one or more clinical trial sites to assure compliance with GCP requirements.
The testing and data acquisition process for an approvable NDA or BLA requires substantial time, effort and financial resources, and takes several years to complete. Data obtained from preclinical and clinical testing are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval of an NDA or BLA on a timely basis, or at all.
After evaluating the NDA or BLA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA or BLA and may require additional clinical or preclinical testing in order for FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase IV clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and additional FDA review and approval procedures.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals, there is no reasonable expectation that sales of the drug in the United States will be sufficient to offset the costs of developing and making the drug available in the United States. Orphan drug designation must be requested before submitting an NDA or BLA. Orphan drug designation does not convey any advantage in or shorten the duration of, the regulatory review and approval process. If the FDA approves a Sponsor’s marketing application for a designated orphan drug for use in the rare disease or condition for which it was designated, the Sponsor is eligible for a seven-year period of marketing exclusivity, during which the FDA may not approve another Sponsor’s marketing application for a drug with the same active moiety and intended for the same use or indication as the approved orphan drug, except in limited circumstances, such as if a subsequent Sponsor demonstrates its product is clinically superior. During a Sponsor’s orphan drug exclusivity period, competitors, however, may receive approval for drugs with different active moieties for the same indication as the approved orphan drug, or for drugs with the same active moiety as the approved orphan drug, but for different indications. Orphan drug exclusivity could block the approval of one of our products for seven years if a competitor obtains approval for a drug with the same active moiety intended for the same indication, unless we are able to demonstrate that grounds for withdrawal of the orphan drug exclusivity exist, or that our product is clinically superior. Further, if a designated orphan drug receives marketing approval for an indication broader than the rare disease or condition for which it received orphan drug designation, it may not be entitled to exclusivity.
Pediatric Development
Under the Pediatric Research Equity Act, certain NDAs, BLAs or supplements to an NDA or BLA must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan designation.
Data Exclusivity
In the U.S., applications for generic small molecule medicinal products may not need to include the results of preclinical and clinical trials, but instead can refer to the data included in the marketing authorization of a reference product for which regulatory data exclusivity has expired.
In the U.S., the Abbreviated New Drug Application, or ANDA, contains data which is submitted to FDA for the review and potential approval of a small molecule generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
Post-approval Requirements
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, changes to the approved product, such as adding new indications, manufacturing changes or other labeling claims, are subject to further testing requirements and in many cases prior FDA review and approval. There also are continuing annual user fee requirements for marketed products and the establishments at which such products are manufactured, as well as application fees for supplemental applications with clinical data. Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, including a boxed warning, require that post-approval studies, including Phase IV clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs.
In addition, manufacturers and other entities involved in the manufacture and distribution of approved drugs or biologics are subject to periodic unannounced inspections by the FDA for compliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.
Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:
•restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
•fines, warning letters or holds on post-approval clinical trials;
•refusal of the FDA to approve pending NDAs, BLAs or supplements to approved NDAs, BLAs, or suspension or revocation of product approvals;
•product seizure or detention, or refusal to permit the import or export of products; or
•injunctions or the imposition of civil or criminal penalties.
The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs or biologics may be promoted only for the approved indications and in accordance with the provisions of the approved label, although physicians, in the practice of medicine, may prescribe approved products for unapproved indications. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.
In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.
Federal and State Fraud and Abuse, Data Privacy and Security, and Transparency Laws and Regulations
In addition to FDA restrictions on marketing of pharmaceutical products, federal and state healthcare laws and regulations restrict business practices in the biopharmaceutical industry. These laws may impact, among other things, our current and future business operations, including our clinical research activities, and sales, marketing and education programs and constrain the business or financial arrangements and relationships with healthcare providers and other parties through which we market, sell and distribute RUCONEST® and other products for which we obtain marketing approval. These laws include anti-kickback and false claims laws and regulations, data privacy and security, and transparency laws and regulations, including, without limitation, those laws described below.
The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term “remuneration” has been broadly interpreted to include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Although there are a number of statutory exemptions and regulatory safe harbors protecting some common activities from prosecution, the exemptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute has been violated.
A person or entity does not need to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act or the civil monetary penalties statute, which imposes penalties against any person who is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.
Federal false claims laws, including the federal civil False Claims Act, prohibits any person or entity from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government. A claim includes “any request or demand” for money or property presented to the U.S. government. Pharmaceutical and other healthcare companies have been prosecuted under these laws for, among other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. Additionally, pharmaceutical and other companies also have been prosecuted for causing false claims to be submitted because of the companies’ marketing of products for unapproved, and thus non-reimbursable, uses.
The HIPAA, created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Also, many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.
In addition, we may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, imposes specified requirements on certain types of individuals and entities, including covered entities (health plans, health clearinghouses, and certain healthcare providers) and their business associates and their subcontractors relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s security standards directly applicable to “business associates”, defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, many of which are not pre-empted by HIPAA, differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with specific exceptions) to report annually to the CMS, information related to payments or other transfers of value made to physicians (as defined by such law) and other healthcare professionals (such as physicians assistants and nurse practitioners), teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS, as well as ownership and investment interests held by the physicians and their immediate family members.
We may also be subject to state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, as well as state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Additionally, certain state and local laws require the registration of pharmaceutical sales representatives.
Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, it is possible that some of our business activities could be subject to challenge under one or more of such laws. If our operations are found to be in violation of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including criminal and significant civil monetary penalties, damages, fines, imprisonment, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm, diminished profits and future earnings, disgorgement, exclusion from participation in government healthcare programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.
The FCPA, Dutch Anti- Bribery Laws and Other Laws
The FCPA prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the Company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. Activities that violate the FCPA, even if they occur wholly outside the United States, can result in criminal and civil fines, imprisonment, disgorgement, oversight, and debarment from government contracts.
Our operations are also subject to non-U.S. anti-corruption laws such as Dutch anti-bribery laws as contained in the Dutch Criminal Code (Wetboek van Strafrecht). These laws generally prohibit companies and persons (including us and our employees) and intermediaries from offering, providing, requesting or accepting, directly or indirectly, a gift promise or service, or anything else of value, to or from domestic or foreign government officials or to or from other persons employed or acting as an agent in relation to an act or omission to be committed or having been committed in the official’s office or, as it concerns other persons employed or agents, in violation of the other person’s duty.
We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of The Netherlands and the United States and authorities in the EU, including, for example, applicable export control regulations, trade and economic sanctions and embargoes on certain countries, persons, groups, entities, projects or activities, anti-money laundering laws, import and customs requirements and currency exchange regulations, collectively referred to as trade control laws.
Failure to comply with the FCPA, Dutch anti-bribery laws and other anti-corruption laws and trade control laws could subject us and others involved to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses.
European Union
The process required by the EMA and EC before a medicinal product may be marketed, is similar to that described for the FDA, and it generally involves:
•completion of preclinical laboratory tests, animal studies and formulation studies in compliance with good laboratory practice, or GLP;
•CTA submissions, which must be approved by each Member State concerned before human clinical trials may begin;
•a positive opinion by an independent Ethics Committee in each Member State concerned;
•performance of adequate and well-controlled clinical trials, in accordance with good clinical practice, or GCP, requirements to establish the efficacy of the proposed drug for each indication;
•submission of an MAA;
•satisfactory completion of an inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with GMP requirements, and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;
•satisfactory completion of an inspection of selected clinical sites to assure compliance with GCP and the integrity of the clinical data;
•EMA evaluation and opinion on the MAA; and
•granting of the Marketing Authorization, or MA, by the EC based on EMA recommendation.
Additionally, medicinal products, including advanced therapy medicinal products, or ATMPs, are subject to extensive pre- and post-market regulation by regulatory authorities at both the EU and national levels. ATMPs comprise gene therapy products, somatic-cell therapy products and tissue engineered products. Tissue engineered products are engineered cells and tissues (i.e., cells/tissues that have undergone substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved) that are presented has having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue. RUCONEST® is regulated as an ATMP in the EU.
There is, furthermore, legislation at an EU level relating to the standards of quality and safety for the collection and testing of human blood and blood components for use in human cell-based therapies, which is applicable to the manufacturing of our human blood and/or cell based products. There is national legislation in various EU Member States, which may be more restrictive than the EU legislation. Differing national requirements of the EU Member States may make setting up compliant cross border supply chains challenging.
Pharmaceutical and Preclinical Tests
Applicants that submit full applications (i.e., they are not biolosimilars or generics), must submit the results of pharmaceutical and pre-clinical tests. The pharmaceutical tests evaluate physico-chemical, biological and microbiological characteristics of the product. The pre-clinical tests consider the pharmacological and toxicological characteristics. These provide important information on the quality, safety and efficacy of the product. Such non-clinical data will form part of the MA application. Additionally, a Sponsor must submit the results of the non-clinical tests, together with manufacturing information, analytical data and any available clinical data or literature, among other things, in the CTA. Some non-clinical testing may continue even after the CTA has been granted. As discussed further below, before a clinical trial can commence, the competent authorities of the Member States in which clinical trials are performed will review the CTA and determine whether to approve the clinical trial. As such, issues with non-clinical test results may lead to competent authorities refusing to approve the clinical trials.
Clinical Trials
Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations and the International Conference on Harmonization, or ICH, guidelines on Good Clinical Practices, or GCP. Additional GCP guidelines from the EC, focusing in particular on traceability, apply to clinical trials of ATMPs. The sponsor must take out a clinical trial insurance policy, and in most EU Member States, the sponsor is liable to provide “no fault” compensation to any study subject injured in the clinical trial.
Prior to commencing a clinical trial, the Sponsor must obtain a clinical trial authorization from the competent authority, and a positive opinion from an independent Ethics Committee in each Member State in which the trial is conducted. The Sponsor of the clinical trial must submit an application dossier, which must include, among other things, a copy of the trial protocol, an investigator’s brochure, documentation relating to compliance with GMP and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation.
Ongoing clinical trials may continue to be governed by the previous Clinical Trials Directive 2001/20/EC. However, as of January 31, 2023, all new applications for clinical trials are governed in accordance with the Clinical Trials Regulation (EU) No 536/2014, or CTR. The CTR allows Sponsors to submit one combined CTA to the Competent Authorities, or CAs, and Ethics Committees for all trial sites in EU countries intended to participate in a given trial via a centralized system. The application entails a two-part assessment process where Part 1 is the scientific assessment coordinated by a reporting member state, or RMS, and Part 2 is the member state specific ethical assessment. Clinical trial approvals for all Member States will be released as a decision following both, competent authority and Ethics Committee assessment per country (under the Directive, applications and approvals/opinions were given on a country-by-country basis. Optimally, this efficiency will condense milestones for site activations in the EU.
Medicinal products used in clinical trials must be manufactured in accordance with GMP. Other national and EU-wide regulatory requirements also apply.
During the development of a medicinal product, the EMA and national medicinal products competent authorities within the EU provide the opportunity for dialogue and guidance on the development program. At the EMA level, this is usually done in the form of scientific advice, which is given by the Scientific Advice Working Party of the CHMP. A fee is incurred with each scientific advice procedure. Advice from the EMA is typically provided based on questions concerning, for example, quality (chemistry, manufacturing and controls testing), nonclinical testing and clinical studies, and pharmacovigilance (also known as drugs safety) plans and risk-management programs. Such scientific advice, in accordance with EMA policy, is not legally binding with regard to any future MAA of the product concerned however it is helpful in product development and understanding EMA expectations.
Orphan Drug Designation and Exclusivity
Regulation (EC) No. 141/2000 as implemented by Regulation (EC) No. 847/2000 provides that a product can be designated as an orphan medicinal drug by the European Commission if its sponsor can establish: that the product is intended for the diagnosis, prevention or treatment of (1) a life-threatening or chronically debilitating condition affecting not more than five in ten thousand persons in the EU when the application is made, or (2) a life-threatening, seriously debilitating or serious and chronic condition in the EU and that without incentives it is unlikely that the marketing of the drug in the EU would generate sufficient return to justify the necessary investment. For either of these conditions, the applicant must demonstrate that there exists no satisfactory method of diagnosis, prevention, or treatment of the condition in question that has been authorized in the EU or, if such method exists, the applicant’s medicinal product has to be of significant benefit compared to products available for the condition.
In the EU, an application for designation as an orphan product can be made any time prior to the filing of the MAA. Orphan medicinal product designation entitles an applicant to incentives such as fee reductions or fee waivers, protocol assistance, and access to the centralized MA procedure. Upon grant of an MA, orphan medicinal products are entitled to a ten-year period of market exclusivity for the approved therapeutic indication, which means that the EMA cannot accept another MAA, or grant an MA, or accept an application to extend an MA for a similar product for the same indication for a period of ten years. The period of market exclusivity is extended by two years for orphan medicinal products that have also complied with an agreed PIP. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications. Orphan medicinal product designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
The period of market exclusivity may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria on the basis of which it received orphan medicinal product destination, including where it can be demonstrated on the basis of available evidence that the original orphan medicinal product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold.
Additionally, an MA may be granted to a similar medicinal product with the same orphan indication during the ten-year period if: (i) the MA holder of the authorized product consents to a second original orphan medicinal product application, (ii) the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities; or (iii) the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior to the authorized orphan medicinal product. A company may voluntarily remove a product from the register of orphan products. A “similar medicinal product” is defined as a medicinal product containing a similar active substance or substances as contained in an authorized orphan medicinal product, and which is intended for the same therapeutic indication. A “similar active substance” is “an identical active substance, or an active substance with the same principal molecular structural features (but not necessarily all of the same molecular structural features) and which acts via the same mechanism. However, in the case of advanced therapy medicinal products, for which the principal molecular structural features cannot be fully defined, the similarity between two active substances shall be assessed on the basis of the biological and functional characteristics.”
Marketing Authorizations
To obtain a MA, for a product in the EU, an applicant must submit an MAA, either under a centralized procedure administered by the EMA, or one of the procedures administered by competent authorities in the EU Member States (decentralized procedure, national procedure or mutual recognition procedure). An MA may be granted only to an applicant established in the EU.
The centralized procedure provides for the grant of a single MA by the European Commission that is valid for all EU and European Economic Area, or EEA, Member States. Pursuant to Regulation (EC) No 726/2004, the centralized procedure is compulsory for specific products, including for (i) medicinal products derived from biotechnological processes, (ii) products designated as orphan medicinal products, (iii) ATMPs, and (iv) products with a new active substance indicated for the treatment of HIV/AIDS, cancer, neurodegenerative diseases, diabetes, auto-immune and other immune dysfunctions and viral diseases. For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients' authorization through, the centralized procedure is optional on related approval.
Under the centralized procedure, the EMA’s CHMP is responsible for conducting the initial assessment of a product. The CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing MA.
Under the centralized procedure in the EU, the maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops when additional information or written or oral explanation is to be provided by the applicant in response to questions of the CHMP. Accelerated assessment may be granted by the CHMP in exceptional cases, when a medicinal product targeting an unmet medical need is expected to be of major interest from the point of view of public health and, in particular, from the viewpoint of therapeutic innovation. If the CHMP accepts a request for accelerated assessment, the time limit of 210 days will be reduced to 150 days (not including clock stops). The CHMP can, however, revert to the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment.
For the evaluation of ATMPs such as RUCONEST®, the Committee for Advanced Therapies, or CAT, is responsible in conjunction with the CHMP for their evaluation. The CAT is primarily responsible for the scientific evaluation of ATMPs and prepares a draft opinion on the quality, safety and efficacy of each ATMP for which an MAA is submitted. The CAT’s opinion is then taken into account by the CHMP when giving its final opinion regarding the authorization of a product in view of the balance of benefits and risks identified. The CAT’s opinion is submitted to the CHMP for final approval, as such the CHMP may depart from the opinion, if it provides detailed scientific justification. The CHMP and CAT are also responsible for providing guidelines on ATMPs and have published numerous guidelines, including specific guidelines on gene therapies and cell therapies. These guidelines provide additional guidance on the factors that the EMA will consider in relation to the development and evaluation of ATMPs and include, among other things, the preclinical studies required to characterize ATMPs; the manufacturing and control information that should be submitted in an MAA; and post-approval measures required to monitor patients and evaluate the long-term efficacy and potential adverse reactions of ATMPs.
Unlike the centralized authorization procedure, the decentralized MA procedure requires a separate application to, and leads to separate approval by, the competent authorities of each EU Member State in which the product is to be marketed. This application is identical to the application that would be submitted to the EMA for authorization through the centralized procedure. The reference EU Member State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. The resulting assessment report is submitted to the concerned EU Member States who, within 90 days of receipt, must decide whether to approve the assessment report and related materials. If a concerned EU Member State cannot approve the assessment report and related materials due to concerns relating to a potential serious risk to public health, disputed elements may be referred to the Heads of Medicines Agencies’ Coordination Group for Mutual Recognition and Decentralized Procedures – Human, or CMDh. If the CMDh cannot reach an agreement within 60 days, the matter is brought to the attention of the CHMP. The CHMP will forward its opinion to the European Commission, who will then make a final decision. The subsequent decision of the European Commission is binding on all EU Member States.
The mutual recognition procedure allows companies that have a medicinal product already authorized in one EU Member State to apply for this authorization to be recognized by the competent authorities in other EU Member States. Like the decentralized procedure, the mutual recognition procedure is based on the acceptance by the competent authorities of the EU Member States of the MA of a medicinal product by the competent authorities of other EU Member States. The holder of a national MA may submit an application to the competent authority of an EU Member State requesting that this authority recognize the MA delivered by the competent authority of another EU Member State.
An MA granted by any route has an initial validity of five years in principle. The MA may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent national authority of the EU Member State in which the original MA was granted. To support the application, the MA holder must provide the EMA or the competent national authority with a consolidated version of the Common Technical Document, or the eCTD, providing up-to-date data concerning the quality, safety and efficacy of the product, including all variations introduced since the MA was granted, at least nine months before the MA ceases to be valid. The European Commission or the competent authorities of the EU Member States may decide, on justified grounds relating to pharmacovigilance, to proceed with one further five year renewal period for the MA. Once subsequently definitively renewed, the MA shall be valid for an unlimited period. However, any authorization which is not followed by the actual placing of the medicinal product on the EU market (for a centralized MA) or on the market of the authorizing EU Member State within three years after authorization ceases to be valid (the so-called sunset clause).
Innovative products that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development and review programs, such as the Priority Medicines, or PRIME, scheme, which provides incentives similar to the breakthrough therapy designation in the U.S. PRIME is a voluntary scheme aimed at enhancing the EMA’s support for the development of medicinal products that target unmet medical needs. Eligible products must target conditions for which there is an unmet medical need (there is no satisfactory method of diagnosis, prevention or treatment in the EU or, if there is, the new medicinal product will bring a major therapeutic advantage) and they must demonstrate the potential to address the unmet medical need by introducing new methods of therapy or improving existing ones. Benefits accrue to sponsors of product candidates with PRIME designation, including but not limited to, early and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements, and potentially accelerated MAA assessment once a dossier has been submitted.
In the EU, a “conditional” MA may be granted in cases where all the required safety and efficacy data are not yet available. The European Commission may grant a conditional MA to medicinal products intended for treating, preventing or diagnosing seriously debilitating or life-threatening diseases. A conditional MA can be granted if it is demonstrated that all of the following criteria are met: (i) the benefit-risk balance of the medicinal product is positive; (ii) it is likely that the applicant will be able to provide comprehensive data post-authorization; (iii) the medicinal product fulfills an unmet medical need; and (iv) the benefit of the immediate availability to patients of the medicinal product is greater than the risk inherent in the fact that additional data are still required. The conditional MA is subject to conditions to be fulfilled for generating the missing data or ensuring increased safety measures. It is valid for one year and must be renewed annually until all related conditions have been fulfilled. Once any pending studies are provided, the conditional MA can be converted into a standard MA. However, if the conditions are not fulfilled within the timeframe set by the EMA and approved by the European Commission, the MA will cease to be renewed.
An MA may also be granted “under exceptional circumstances” where the applicant can show that it is unable to provide comprehensive data on efficacy and safety under normal conditions of use even after the product has been authorized and subject to specific procedures being introduced. These circumstances may arise in particular when the intended indications are very rare and, in the state of scientific knowledge at that time, it is not possible to provide comprehensive information, or when generating data may be contrary to generally accepted ethical principles. Like a conditional MA, an MA granted in exceptional circumstances is reserved to medicinal products intended to be authorized for treatment of rare diseases or unmet medical needs for which the applicant does not hold a complete data set that is required for the grant of a standard MA. However, unlike the conditional MA, an applicant for authorization in exceptional circumstances is not subsequently required to provide the missing data. Although the MA “under exceptional circumstances” is granted definitively, the risk-benefit balance of the medicinal product is reviewed annually and the MA will be withdrawn if the risk-benefit ratio is no longer favorable.
In addition to an MA, various other requirements apply to the manufacturing and placing on the EU market of medicinal products. Manufacture of medicinal products in the EU requires a manufacturing authorization, and import of medicinal products into the EU requires a manufacturing authorization allowing for import, collectively known as MIAs. The manufacturing authorization holder must comply with various requirements set out in the applicable EU laws, regulations and guidance. These requirements include compliance with EU GMP standards when manufacturing medicinal products and APIs, including the manufacture of APIs outside of the EU with the intention to import the APIs into the EU. Similarly, the distribution of medicinal products within the EU is subject to compliance with the applicable EU laws, regulations and guidelines, including the requirement to hold appropriate authorizations for distribution granted by the competent authorities of the EU Member States. MA holders and/or manufacturing and import authorization, or MIA holders and/or distribution authorization holders may be subject to civil, criminal or administrative sanctions, including suspension of manufacturing authorization, in cases of non-compliance with the EU or EU Member States’ requirements applicable to the manufacturing of medicinal products.
EU Member States may adopt national legislation prohibiting or restricting the sale, supply or use of any medicinal product containing, consisting of or derived from a specific type of human or animal cell, such as embryonic stem cells. While the products we have in development do not make use of embryonic stem cells, it is possible that the national laws in certain EU Member States may prohibit or restrict us from commercializing our products, even if they have been granted an EU marketing authorization.
Pediatric Development
In the EU, companies developing a new medicinal product must agree to a PIP, covering all subsets of pediatric population, and must conduct pediatric clinical trials in accordance with that PIP, unless a deferral or waiver applies, (for example, because the relevant disease or condition occurs only in adults). The MAA for the product must include the results of pediatric clinical trials conducted in accordance with the PIP, unless a waiver applies (in which case pediatric clinical trials need not be performed), or a deferral has been granted (in which case the pediatric clinical trials must be completed at a later date). Products that are granted a marketing authorization on the basis of the pediatric clinical trials conducted in accordance with the PIP are eligible for a six-month extension of the protection under a supplementary protection certificate (if any is in effect at the time of approval) or, in the case of orphan medicinal products, a two year extension of the orphan market exclusivity. This pediatric reward is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.
Data and Market Exclusivity
The EU provides opportunities for data and market exclusivity related to MAs. Innovative medicinal products are generally entitled to benefit from eight years of data exclusivity and a further two years of market exclusivity (providing a total of 10 years of regulatory data protection). Data exclusivity prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from the date of authorization of the innovative product. After this period has expired an MAA for a generic or biosimilar may be submitted, and the innovator’s data may be referenced. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product (i.e., until 10 years have elapsed from the initial MA for the reference product in the EU).
The market exclusivity period may be extended for a further year to a maximum of 11 years from the initial MA if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.
Post-approval Requirements
Similar to the post-approval process in the United States, drugs or biologics manufactured or distributed pursuant to marketing authorizations in the EU are subject to continuing regulation, including, among other things, requirements relating to periodic safety reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After authorization, changes to the approved product, such as adding new indications, manufacturing changes or other labeling claims, are subject to further testing requirements and prior EMA review and/or EC approval.
Additionally, the holder of a marketing authorization must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance, or QPPV, who is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports, or PSURs.
All new MAAs must include a risk management plan, or RMP, describing the risk management system that the Company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the marketing authorization. Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies. RMPs and PSURs are routinely available to third parties requesting access, subject to limited redactions.
Advertising Regulation
In the EU, the advertising and promotion of medicinal products are subject to both EU and EU Member States’ laws (as well as codes of conduct that can be enforced on members of those codes) governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices. Although general requirements for advertising and promotion of medicinal products are established under EU directives, the details are governed by regulations in individual EU Member States and can differ from one country to another. For example, applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product’s Summary of Product Characteristics, or SmPC, as approved by the competent authorities in connection with an MA. The SmPC is the document that provides information to physicians concerning the safe and effective use of the product. Promotional activity that does not comply with the SmPC is considered off-label and is prohibited in the EU. Direct-to-consumer advertising of prescription medicinal products is also prohibited in the EU.
EU Pharmaceutical Legislation Review
The European Commission is in the process of amending the EU’s general pharmaceutical legislation. Although, the updated legislation will not enter into force for a number of years, it should be noted that there will be wide ranging changes to the laws as set out above. Notably, the Commission intends to change rules on data protection/market exclusivity, orphan medicinal products and pediatric development.
United Kingdom
On January 31, 2020, the United Kingdom left the EU (commonly referred to as Brexit) and accordingly is no longer an EU Member State. A transition period began on February 1, 2020, during which EU pharmaceutical law remained applicable to the United Kingdom, however this period ended on December 31, 2020. After this date, EU law no longer applied.
On December 24, 2020, the United Kingdom and the EU announced that they had reached agreement on the terms of their future relationship as set out in the Trade and Cooperation Agreement, or the TCA. The EU and the United Kingdom had agreed to provisionally apply the terms of the TCA, while the formal execution was still ongoing. The TCA formally entered into force on May 1, 2021. While the TCA governs tariff and quota free trade between the United Kingdom and the EU markets, it does not provide for regulatory alignment. The regulatory framework for medicinal products in the United Kingdom is predominantly derived from EU law.
As the United Kingdom is no longer an EU Member State, the United Kingdom’s participation in the European Medicines Regulatory Network has ceased and the MHRA has assumed the functions that were previously undertaken by the EU institutions for human medicines on the United Kingdom market. This is, with the exception of Northern Ireland, which, pursuant to the Protocol on Ireland/Northern Ireland has remained aligned with EU regulations; however, following the UK Government and European Commission’s political agreement in principle on the Windsor Framework, the MHRA will be responsible for all medicinal products placed on the market anywhere in the United Kingdom. The MHRA has published detailed guidance for industry and organizations that is updated as the United Kingdom’s regulatory position on medicinal products evolves over time.
Currently, the EU centralized MAs do not apply in Great Britain but do apply in Northern Ireland. However, the Windsor Framework provides that in future all MAs in the United Kingdom (including those for Northern Ireland) will require the MHRA to grant a UK MA. As such, in addition to the pre-existing standard 210 day assessment route for national MA in the United Kingdom, at the moment the United Kingdom offers new assessment procedures to obtain marketing authorization in the United Kingdom. The procedures can lead to a marketing authorization in Great Britain (England, Scotland, and Wales), the United Kingdom, or Northern Ireland, depending on the procedure and pre-existing authorizations, as further explained below. The new assessments include:
•The IRP which replaced the ECDRP from January 1, 2024. The IRP allows a company to submit an MAA for a product on an abbreviated review timeline if the same product has already received approval from one of the MHRA’s specified RRs, including the EMA, the national regulators of the EU Member States and the FDA. A positive CHMP opinion is deemed to be an RR approval for these purposes. If the RR approval was granted within the past 2 years and the manufacturing supply chain for the UK is identical to that approved under the RRA approval, the product may be eligible for Recognition Route A, which gives the MRHA 60 days from the date the IRP submission is validated to reach a decision, and there is no possibility of a clock-stop. For other products, including all ATMPs, the MAA will be assessed under Recognition Route B, which gives the MHRA 110 days from the date the IRP submission is validated to reach a decision, and the MHRA may impose a 60 day clock stop if necessary to request additional information from the applicant;
•A full assessment as a national authorization, that industry can choose for new active substances, with high-quality new MAAs with a timeline of no more than 150 days (excluding clock-off periods where further information is requested) which can lead to the grant of a marketing authorization in Great Britain, the United Kingdom, or Northern Ireland. If the application includes Northern Ireland then it must comply with the relevant EU requirements;
•The Unfettered Access Procedure for medicines already approved in Northern Ireland via the EU procedures or via the Northern Ireland national route which if successful will lead to a Great Britain marketing authorization. This procedure means that the MHRA will recognize such MAs in Great Britain within 67 days of MAA validation, unless a major objection is identified; and
•A “rolling review”, for new active substances and biosimilars, which would allow companies to make an application in stages, throughout the product’s development, to better manage development risk which can lead to the grant of a marketing authorization in Great Britain, the United Kingdom, or Northern Ireland. If the application includes Northern Ireland then it must comply with the relevant EU requirements.
However, these may change in future due, for example, to the Windsor Framework and the changes to the EU’s general pharmaceutical legislation.
Domestic UK law provided that all existing EU law in force on December 31, 2020 was retained in UK national law, subject to certain revisions that have become necessary as a result of Brexit. However, the Retained EU Law (Revocation and Reform) Act 2023 came into force on January 1, 2024. This revoked some retained EU laws (although not any relating to medicines regulation). All other retained EU laws have been renamed as “assimilated laws” and are no longer subject to the EU principles of interpretation. Thus, while at least initially the United Kingdom and the European Union laws relating to medicines are largely aligned, there is the potential for further divergence in the future..
Rest of World, or ROW
Similar to that in the U.S. and in Europe, countries around the globe have their own health authority(ies), legal basis of regulation of medicinal products, and independent clinical trial and registration procedures and processes. Conformance and compliance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, or ICH, is typically acceptable in countries worldwide with additional local particulars.
In general, from a clinical trial perspective, requirements for conduct of a trial are similar to that of the U.S. and EU and consist of a CTA and Ethics Committee review.
In both the United States and the EU, there are dedicated regulatory pathways for biosimilars, or biological medicinal products that are highly similar to a reference medicinal product but that do not meet the definition of a generic medicinal product, for example, because of inherent biological differences present in such biological systems. For such products, the results of appropriate preclinical or clinical trials must be provided, and guidelines from FDA or EMA detail the type of quantity of additional nonclinical, clinical and CMC data to be provided for submission of a highly similar biological product. Given the complexity of the requirements in the biosimilar route when compared to the generic drug pathway(s), there have been limited biosimilar approvals globally, however this pathway appears to be gaining momentum as innovator companies leverage the process to develop and market their own biosimilars of their own biologic product.
EU and UK Data Privacy
In May 2018, the EU General Data Protection Regulation (EU) 2016/679, or GDPR, went into effect in the EEA. The GDPR imposes stringent data protection requirements for processing the information of individuals in the EEA. In the United Kingdom, the GDPR continues to form part of law in the United Kingdom following the United Kingdom’s withdrawal from the EU, as the UK GDPR, (by virtue of Section 3 of the EU (Withdrawal) Act 2018, as amended (including by the various Data Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations)), thus imposing similarly stringent data protection requirements in the United Kingdom, as in the EEA. To date, the GDPR and UK GDPR have increased compliance burdens on us, such as requiring the following: processing personal data only for specified, explicit and legitimate purposes for which personal data were collected; establishing a legal basis for processing personal data; creating obligations for controllers and processors to appoint data protection officers in certain circumstances; increasing transparency obligations to data subjects for controllers (including presentation of certain information in a concise, intelligible and easily accessible form about how their personal data is used and their rights vis-à-vis that data and its use); introducing the obligation to carry out so-called data protection impact assessments in certain circumstances; establishing limitations on collection and retention of personal data through “data minimization” and “storage limitation” principles; establishing obligations to implement “privacy by design”; introducing obligations to honor increased rights for data subjects (such as rights for individuals to be “forgotten,” rights to data portability, rights to object etc. in certain circumstances); formalizing a heightened and codified standard of data subject consent; establishing obligations to implement certain technical and organizational safeguards to protect the security and confidentiality of personal data; introducing obligations to agree to certain specific contractual terms and to take certain measures when engaging third party processors and joint controllers; introducing the obligation to provide notice of certain significant personal data breaches to the relevant supervisory authority or authorities and affected individuals; and mandating the appointment representatives in the United Kingdom and/or EU in certain circumstances. The processing of sensitive personal data, such as health information, may impose heightened compliance burdens under the GDPR/UK GDPR and is a topic of active interest among foreign regulators. The GDPR/UK GDPR increases our obligations with respect to clinical trials conducted in Europe (including the EEA and United Kingdom) by expressly expanding the definition of personal data to include “pseudonymized” or key-coded data and requiring changes to informed consent practices and more detailed notices for clinical trial subjects and investigators.
Further guidance on how to comply with these obligations in the context of clinical trials may be provided by European regulators in the future, as the European Data Protection Board, or EDPB, has announced back in 2021 that it was working on guidelines on the processing of personal data for scientific research purposes.
The GDPR/UK GDPR also provides for more robust regulatory enforcement and greater penalties for non-compliance than previous data protection laws, including fines of up to €20 million or 4% of global annual revenue of any non-compliant company for the preceding financial year, whichever is higher. In addition to administrative fines, a wide variety of other potential enforcement powers are available to competent supervisory authorities in respect of potential and suspected violations of the GDPR, including extensive audit and inspection rights, and powers to order temporary or permanent bans on all or some processing of personal data carried out by non-compliant actors. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.
European data protection laws, including the GDPR/UK GDPR, generally restrict the transfer of personal data from Europe, including the EEA, United Kingdom and Switzerland, to the United States and most other countries unless the parties to the transfer have implemented specific safeguards to protect the transferred personal data. One of the primary safeguards allowing U.S. companies to import personal data from Europe had been certification to the EU-U.S. Privacy Shield and Swiss-U.S. Privacy Shield frameworks administered by the U.S. Department of Commerce. However, both the EU-U.S. and Swiss-U.S. Privacy Shield frameworks were invalidated following a decision from the Court of Justice of the European Union, or CJEU, in July 2020, in a case known colloquially as “Schrems II.” In the aftermath of this case, a new framework known as the Data Privacy Framework, or DPF, was adopted in 2023 to allow participating U.S. companies to transfer personal data from Europe to the U.S. The DPF entered into force in July 2023 for transfers from the EEA to the U.S., and in October 2023 for transfers from the United Kingdom to the U.S. As a result, U.S. companies who have certified to the DPF can rely on their certification to import personal data from the EEA and the United Kingdom. While the Swiss-U.S. DPF Principles have technically been effective since July 2023, the Swiss Federal Council has yet to recognize the Swiss-U.S. DPF as an adequate safeguard for the transfer of Swiss personal data to the U.S. under Swiss data protection laws. As a result, and until the Swiss Federal Council issues an adequacy decision for the Swiss-U.S.DPF, companies cannot rely on the Swiss-U.S. DPF to transfer personal data from Switzerland to the U.S.. The CJEU’s decision in Schrems II also raised questions about whether another transfer mechanism, namely, the European Commission’s Standard Contractual Clauses, can lawfully be used for personal data transfers from Europe to the United States or other third countries that are not the subject of an adequacy decision of the European Commission. While the CJEU upheld the adequacy of the Standard Contractual Clauses in principle in Schrems II, it made clear that reliance on those Clauses alone may not necessarily be sufficient in all circumstances.
Use of the Standard Contractual Clauses must now be assessed on a case-by-case basis taking into account the legal regime applicable in the destination country, in particular regarding applicable surveillance laws and relevant rights of individuals with respect to the transferred data. In the context of any given transfer, where the legal regime applicable in the destination country may or does conflict with the intended operation of the Standard Contractual Clauses and/or applicable European law, the decision in Schrems II and subsequent draft guidance from the EDPB would require the parties to that transfer to implement certain supplementary technical, organizational and/or contractual measures to rely on the Standard Contractual Clauses as a compliant “transfer mechanism.” However, the EDPB recommendations 01/2020 on measures that supplement transfer tools to ensure compliance with the EU level of protection of personal data, as last adopted on June 18, 2021 conclude that no combination of such measures could be sufficient to allow effective reliance on the Standard Contractual Clauses in the context of transfers of personal data “in the clear” to recipients in countries where the power granted to public authorities to access the transferred data goes beyond that which is “necessary and proportionate in a democratic society” – which may, following the CJEU’s conclusions in Schrems II on relevant powers of United States public authorities and commentary in that draft EDPB guidance, include the United States in certain circumstances (e.g., where Section 702 of the U.S. Foreign Intelligence Surveillance Act applies).
The decision in Schrems II also affects transfers from the United Kingdom to the United States. As such, if we are unable to implement a valid solution for personal data transfers from Europe, including, for example, obtaining individuals’ explicit consent to transfer their personal data from Europe to the United States or other countries, we will face increased exposure to regulatory actions, substantial fines and injunctions against processing personal data from Europe.
Inability to import personal data from the EEA, United Kingdom or Switzerland may also restrict our clinical trials activities in Europe; limit our ability to collaborate with contract research organizations as well as other service providers, contractors and other companies subject to European data protection laws; and require us to increase our data processing capabilities in Europe at significant expense. Additionally, other countries outside of Europe have enacted or are considering enacting similar cross-border data transfer restrictions and laws requiring local data residency, which could increase the cost and complexity of delivering our services and operating our business. The type of challenges we face in Europe will likely also arise in other jurisdictions that adopt laws similar in construction to the GDPR or regulatory frameworks of equivalent complexity.
The GDPR applies across the EEA and, by virtue of the UK GDPR in the United Kingdom, in a broadly uniform manner. However, the GDPR provides that EEA countries may make their own further laws and regulations to introduce specific requirements related to the processing of “special categories of personal data,” including personal data related to health, biometric data used for unique identification purposes and genetic information; as well as personal data related to criminal offences or convictions – in the United Kingdom, the DPA complements the UK GDPR in this regard, and a draft data protection bill has recently been introduced to Parliament to reform the UK data protection legal framework.. This fact may lead to greater divergence on the law that applies to the processing of such data types across the EEA and/or United Kingdom, compliance with which, as and where applicable, may increase our costs and could increase our overall compliance risk. Such country-specific regulations could also limit our ability to collect, use and share data in the context of our EEA and/or United Kingdom establishments (regardless of where any processing in question occurs), and/or could cause our compliance costs to increase, ultimately having an adverse impact on our business, and harming our business and financial condition.
Further, the United Kingdom’s vote in favor of exiting the EU and ongoing developments in the United Kingdom have created uncertainty with regard to data protection regulation in the United Kingdom. Following the United Kingdom’s withdrawal from the EU on January 31, 2020, pursuant to the transitional arrangements agreed to between the United Kingdom and EU, the GDPR continued to have effect in law in the United Kingdom, and continued to do so until December 31, 2020 as if the United Kingdom remained an EU Member State for such purposes. After December 31, 2020, and the expiry of those transitional arrangements, the data protection obligations of the GDPR continue to apply to United Kingdom related to processing of personal data in substantially unvaried form and fashion under the UK GDPR. In the future, however, there will be increasing scope for divergence in application, interpretation and enforcement of the data protection law as between the United Kingdom and the EEA. Furthermore, the relationship between the United Kingdom and the EEA in relation to certain aspects of data protection law remains unclear. However, on June 28, 2021, the European Commission adopted an adequacy decision in relation to the United Kingdom. This decision permits personal data to flow freely from the EEA to the United Kingdom where it benefits from an essentially equivalent level of protection to that guaranteed under EU law. This adequacy decision has, however, a limited duration of four years, meaning that the decision will automatically expire after this period. After expiry of the period, the adequacy decision will be renewed only if the United Kingdom continues to ensure an adequate level of data protection. The reform of the UK data protection regime that is currently considered will likely be decisive as to whether or not the United Kingdom can maintain its adequacy status in the future. Additionally, as noted above, the United Kingdom has transposed the GDPR into United Kingdom domestic law by way of the UK GDPR with effect from in January 2021, and is further looking into reforming its data protection framework, which could expose us to two parallel regimes, each of which potentially authorizes similar fines and other potentially divergent enforcement actions for certain violations.
Additionally, other countries outside of Europe have enacted or are considering enacting similar cross-border data transfer restrictions and laws requiring local data residency, which could increase the cost and complexity of delivering our services and operating our business.
It is possible that the GDPR or other laws and regulations relating to privacy and data protection may be interpreted and applied in a manner that is inconsistent from jurisdiction to jurisdiction or inconsistent with our current policies and practices and compliance with such laws and regulations could require us to change our business practices and compliance procedures in a manner adverse to our business. We cannot guarantee that we are in compliance with all such applicable data protection laws and regulations and we cannot be sure how these regulations will be interpreted, enforced or applied to our operations. Furthermore, other jurisdictions outside the EEA are similarly introducing or enhancing privacy and data security laws, rules, and regulations, which could increase our compliance costs and the risks associated with non-compliance.
It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices and our efforts to comply with the evolving data protection rules may be unsuccessful. We cannot guarantee that we, our third-party collaborators, or our vendors are in compliance with all applicable data protection and privacy laws and regulations as they are enforced now or as they evolve. Further, for example, our privacy policies may be insufficient to protect any personal information we collect, or may not comply with applicable laws. Our non-compliance could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business. In addition to the risks associated with enforcement activities and potential contractual liabilities, our ongoing efforts to comply with evolving laws and regulations at the federal and state level may be costly and require ongoing modifications to our policies, procedures and systems. In addition, if we are unable to properly protect the privacy and security of protected health information, we could be found to have breached our contracts.
Our actual or perceived failure to adequately comply with applicable laws and regulations relating to privacy and data protection, or to protect personal data and other data we process or maintain, could result in regulatory enforcement actions against us, including fines, penalties, orders that require a change in our practices, additional reporting requirements and/or oversight, imprisonment of company officials and public censure, claims for damages by affected individuals, other lawsuits or reputational and damage, all of which could materially affect our business, financial condition, results of operations and growth prospects.
Pricing and Reimbursement
United States
The future commercial success of RUCONEST®, Joenja® and our product candidates or any of our collaborators’ ability to commercialize any approved product candidates successfully will depend in part on the extent to which governmental payor programs at the federal and state levels, including Medicare and Medicaid, private health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for our product candidates. Government health administration authorities, private health insurers and other organizations generally decide which drugs they will pay for and establish reimbursement levels for healthcare. In particular, in the United States, private health insurers and other third-party payors may provide reimbursement for products and services based on the level at which the government, through the Medicare or Medicaid programs, provides reimbursement for such treatments. In the United States, the EU, and other potentially significant markets for our product candidates, government authorities and third-party payors are increasingly attempting to limit or regulate the price of medical products and services, particularly for new and innovative products and therapies, which often has resulted in average selling prices lower than they would otherwise be. Further, the increased emphasis on managed healthcare in the United States will put additional pressure on product pricing, reimbursement and usage, which may adversely affect our future product sales and results of operations. These pressures can arise from rules and practices of managed care groups, judicial decisions and laws and regulations related to Medicare, Medicaid and healthcare reform, pharmaceutical coverage and reimbursement policies and pricing in general.
Third-party payors are increasingly imposing additional requirements and restrictions on coverage and limiting reimbursement levels for medical products. For example, federal and state governments reimburse covered prescription drugs at varying rates generally below average wholesale price. These restrictions and limitations influence the purchase of healthcare services and products. Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved products for a particular indication. Third-party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development. Additionally, coverage policies and third-party reimbursement rates may change at any time. Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future. Legislative proposals to reform healthcare or reduce costs under government insurance programs may result in lower reimbursement for RUCONEST®, Joenja® and product candidates or exclusion of RUCONEST®, Joenja® or our product candidates from coverage.
The cost containment measures that healthcare payors and providers are instituting and any healthcare reform could significantly reduce our revenues from the sale of any approved product candidates. We cannot provide any assurances that we will be able to obtain and maintain third-party coverage or adequate reimbursement for RUCONEST®, Joenja® and our product candidates in whole or in part.
There have been several U.S. government initiatives over the past few years to fund and incentivize certain comparative effectiveness research, including creation of the Patient-Centered Outcomes Research Institute under the ACA. It is also possible that comparative effectiveness research demonstrating benefits in a competitor’s product could adversely affect the sales of our product candidates. If third-party payors do not consider RUCONEST®, Joenja® or our product candidates, once approved, to be cost-effective compared to other available therapies, they may not cover such products as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our product on a profitable basis.
In addition, there have been and continue to be a number of initiatives at the United States federal and state levels that seek to reduce healthcare costs. Furthermore, there has been heightened governmental scrutiny over specialty drug pricing practices, which has resulted in several congressional inquiries and executive orders designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
At the both the federal and state level, legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs are pervasive and a continuing theme subject to review and re-review for alignment with changes in administration(s), as well as with key stakeholders.
These and other healthcare reform initiatives within the U.S. may result in additional reductions in Medicare or other healthcare funding which may impact our ability to achieve the desired pricing for newly developed indications and/or products.
European Union
In the EU, pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare the cost effectiveness of a particular product candidate to currently available therapies (so-called health technology assessments) in order to obtain reimbursement or pricing approval. In general, governments influence the price of medicinal products in the EU through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other EU Member States allow companies to fix their own prices for medicinal products but monitor and control company profits. The downward pressure on healthcare costs in general, particularly prescription medicines, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.
In various EU Member States, continuous cost-cutting measures, such as lower maximum prices, lower or lack of reimbursement coverage and incentives to use cheaper products as an alternative apply. Health Technology Assessment, or HTA, of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures in some EU Member States, including countries representing major markets. The HTA process, which is currently governed by the national laws of these countries, is the procedure according to which the assessment of the public health impact, therapeutic impact and the economic and societal impact of use of a given medicinal product in the national healthcare systems of the individual country is conducted. The outcome of HTA regarding specific medicinal products will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU Member States. On January 31, 2018, the European Commission adopted a proposal for a regulation on health technologies assessment, or the HTA Regulation. In December 2021, the HTA Regulation was adopted and entered into force on January 11, 2022.
It will apply from 2025. The Regulation is intended to boost cooperation among EU Member States in assessing health technologies, including new medicinal products, and providing the basis for cooperation at the EU level for joint clinical assessments in these areas. Entry into application of the Regulation could impose stricter and more detailed procedures to be followed by MAHs concerning conduct of HTA in relation to their products which may influence related pricing and reimbursement decisions.
Outside of the United States and EU
Middle East & North Africa, or the MENA
Pharming creates access to RUCONEST® in the MENA through a mixture of direct sales and marketing, local partnerships, commercial partners and the ongoing utilization of the HAEi GAP program (as defined below) in certain territories. In Israel, our existing partner Kamada has consolidated its RUCONEST® activities. In addition, in 2021, we entered into an exclusive license agreement with Newbridge Pharmaceuticals for the distribution of RUCONEST® in the MENA.
China
We have granted the CSIPI an exclusive license to commercialize RUCONEST® in China, and the CSIPI is collaborating with the CDIBP. On December 15, 2023, the CDIBP announced that it received clinical trial approval from the Center for Drug Evaluation of the National Medical Product Administration for the clinical development of rhC1INH in China. We may receive certain regulatory and manufacturing-associated milestones, and we are eligible to receive low to mid-single digit royalties from sales in China by the CSIPI, affiliates of the CSIPI and sublicensees of the CSIPI.
Other markets
RUCONEST® continues to be commercialized in Colombia, Costa Rica, the Dominican Republic and Panama through our partner, Cytobioteck.
HAEi global access program, or HAEi GAP
RUCONEST® is the first therapy available under the HAEi GAP. This program ensures that in countries where no HAE therapies are approved or otherwise available, all eligible HAE patients can have access to safe and effective treatment through their treating physician. As part of this program, several requests have been received and treatments were started in countries such as South Africa and the Democratic Republic of the Congo. It is the only known program of this type which has been initiated through a patient group (HAEi).
C. Organizational Structure
Pharming Group N.V. is a limited liability public company. Pharming Group N.V. is the ultimate parent company of Pharming Group. A list of our significant subsidiaries at December 31, 2023 is provided in the table below:
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|
|
| Entity |
Registered office |
Ownership percentage |
| Pharming B.V. |
The Netherlands |
100 |
% |
| Pharming Americas B.V. |
The Netherlands |
100 |
% |
| Pharming Intellectual Property B.V. |
The Netherlands |
100 |
% |
| Pharming Technologies B.V. |
The Netherlands |
100 |
% |
| Pharming Research & Development B.V. |
The Netherlands |
100 |
% |
| Broekman Instituut B.V. |
The Netherlands |
100 |
% |
| Pharming Healthcare, Inc. |
The United States |
100 |
% |
| ProBio, Inc. |
The United States |
100 |
% |
D. Property, Plants and Equipment
Our Facilities
In Leiden, The Netherlands, we have our administrative offices (including laboratories) and offices for executive management located on Darwinweg 24, 2333 CR, Leiden and Vondellaan 47, 2332 AA, Leiden, respectively. In the Leiden facilities, we occupy:
•Approximately 1,877 square meters (equivalent to approximately 20,204 square feet) of office space under a lease that has an initial term that expires on June 1, 2029 and can be extended for a period of 5 years.
•Approximately 1,295 square meters (equivalent to approximately 13,939 square feet) of laboratory space under a lease which will expire on June 30, 2026 and will automatically be renewed for an additional period of 5 years.
•Approximately 76 square meters (equivalent to approximately 818 square feet) of storage space under a lease which will expire on June 30, 2026 and will automatically be renewed for an additional period of 5 years.
In addition, in the province of Noord Brabant, The Netherlands, we occupy approximately 3,459 square meters (equivalent to approximately 37,232 square feet), of which 2405 square meters (equivalent to approximately 25,887 square feet) is production space, 926 square meters (equivalent to approximately 9,967 square feet) is office space and 128 square meters (equivalent to approximately 1,378 square feet) is used for support purposes.
At our other production facility in the province of Noord Brabant, The Netherlands, we own approximately 950 square meters (equivalent to approximately 10,226 square feet) of production, warehouse and office space.
At the (cattle) facility in the province of Zuid Holland, The Netherlands, we occupied approximately 150 square meters (equivalent to approximately 1,615 square feet) of storage space under a lease that had an expiry date of September 1, 2026. With the discontinuation of the cattle program, we terminated the lease as of January 1, 2024.
Since 2022, we lease approximately 4,514 square meters (equivalent to approximately 48,588 square feet) of production, warehouse and office space in the province of Noord Brabant. We currently do not use this facility and remain exploring alternative utilization possibilities.
At our research and development facility near Paris, France, we occupy approximately 884 square meters (equivalent to approximately 9,515 square feet) of office space under a lease which has an expiry date of February 28, 2026. We also occupy approximately 214 square meters of laboratory space (equivalent to approximately 2,303 square feet) under a lease that expires on August 31, 2027.
In New Jersey, United States, we occupy approximately 1,732.64 square meters (equivalent to approximately 18,650 square feet) of office space under a lease that runs until 2025.
We invested $1.4 million and $1.4 million in 2023 and 2022 respectively, mainly in new machinery and laboratory equipment.
Item 4A. Unresolved Staff Comments
None.
Item 5. Operating and Financial Review and Prospects
You should read the following “Operating and Financial Review and Prospects” together with our financial statements and Notes included elsewhere in this Annual Report. The following discussion is based on our financial information prepared in accordance with IFRS, as issued by the International Accounting Standards Board, or IASB.
The statements in this discussion with respect to our plans and strategy for our business, including expectations regarding our future liquidity and capital resources and other non-historical statements, are forward-looking
statements. These forward-looking statements are subject to numerous risks and uncertainties, including the risks and uncertainties described in the section of this Annual Report titled “Risk Factors.” Our actual results may differ materially from those contained in or implied by any forward-looking statements.
A. Operating Results
Overview
RUCONEST's® importance continued to be felt throughout 2023 as we increased the number of physicians prescribing RUCONEST®, as well as the number of patients. RUCONEST® revenues in 2023 increased by 10%, driven by revenue growth in the U.S.
With respect to Joenja® (leniolisib), we increased investment in the U.S. as we began commercialization. During the nine months following the launch in April 2023, we made strong and rapid progress transitioning known patients onto commercial therapy. Joenja® revenues were $18.2 million for the full year 2023.
The U.S. launch of Joenja®, and preparations for anticipated approvals in the European Economic Area and additional geographies, resulted in additional expenses in research and development, marketing and sales and payroll. Research and clinical development activities related to leniolisib were further focused on pediatric and Japan clinical trials for APDS and research on the use of leniolisib for additional PIDs beyond APDS. We believe that these investments will support our continued growth following approvals.
In addition, research and clinical development activities were further focused as the program related to Pompe was discontinued. As such, we maintained a strong financial position in 2023.
We intensified our business development activities for in-licensing or acquisition of additional clinical stage assets in rare or ultra-rare diseases, but did not engage in any such transactions in 2023.
Components of our Results of Operations
Revenues
We generate revenues primarily from the sale of RUCONEST® and Joenja®. Most of our contracts for revenues with customers are subject to chargebacks, discounts and/or rebates relating to customers or to reimbursement claims from government or insurance payers.
Costs of Sales
Costs of sales consist of cost of product sales, relating to actual product sales, royalty expenses and inventory impairments. The impairment stems from the valuation of the inventories against lower net realizable value.
Other income
Other income is comprised largely of grants in the form of annual payroll-tax reimbursement granted by the Dutch and French governments for research and development activities that we conduct in those countries and the proceeds from the sale of a Pediatric Disease Priority Voucher, or PRV, to Novartis, as discussed below.
Cost of research and development
Research and development costs relate to the preparation and initiation of our product candidates lifecycle. Development expenditures that meet the capitalization criteria are capitalized. Expenditures which do not meet these criteria are recorded as expenses through the income statement.
Cost of general and administrative activities
Consists of costs related to administration resources, service fees, legal and due diligence costs and impairment and depreciation costs for property, plant and equipment and intangible assets.
Cost of marketing and sales activities
These costs relate to all expenses incurred to commercialize a product.
Other finance expense
Other finance expense comprise primarily interest paid on our convertible bonds due 2025 and our lease liabilities and foreign currency results.
Share of net profits in associates using the equity method
Share of net profits in associates comprises the profit resulting from our investment in BioConnection. During the second quarter of 2022, Pharming entered into a share purchase agreement, following receipt of an offer for all shares in BioConnection B.V. by Gimv, a European investment company listed on Euronext Brussels. The existing shareholders (including Pharming) reached agreement with Gimv on the sale of all issued and outstanding shares to a new holding company (BioConnection Investments B.V.) incorporated by Gimv, followed by a partial re-investment by existing shareholders of the purchase price in the share capital of BioConnection Investments B.V. The re-investment relates to the purchase of ordinary shares and a preference share. The transaction diluted Pharming’s stake in BioConnection from 43.85% in 2021 to 22.98% in 2022. We account for our investment in BioConnection by the equity method and do not consolidate the entity as a subsidiary.
Income tax credit (expense)
Income tax credit reflects credit/(expenses) of income tax. The income tax expense or credit for the period is the tax payable on the current period’s taxable income based on the applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses. The realization of deferred tax assets is dependent upon the generation of future taxable income, the amount and timing of which are subject to uncertainties. Despite the loss in 2023, it is probable that going forward we will be able to use all our remaining net operating tax losses from previous years. During the years ended December 31, 2023, 2022 and 2021, we incurred state and federal income taxes in the United States, in which jurisdiction we have no remaining tax losses available, while in The Netherlands we continue to use up our accumulated tax losses. The tax shielding effect of those remaining tax losses is shown on the balance sheet as a deferred tax asset. The deferred tax asset is utilized by being written down by the amount of the tax charge each reporting period, instead of paying the tax due from cash. Once all the tax losses are used up, the deferred tax asset relating to these losses will be completely extinguished and the tax due thereafter will be paid.
Results of Operations
The following table sets forth our results of operations for the periods presented.
CONSOLIDATED STATEMENT OF INCOME
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|
|
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|
|
|
Years ended December 31, |
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Revenues |
245,316 |
|
|
205,622 |
|
|
198,871 |
|
| Costs of sales |
(25,212) |
|
|
(17,562) |
|
|
(21,142) |
|
| Gross profit |
220,104 |
|
|
188,060 |
|
|
177,729 |
|
| Other income |
23,349 |
|
|
14,523 |
|
|
2,620 |
|
| Research and development |
(68,914) |
|
|
(52,531) |
|
|
(70,369) |
|
| General and administrative |
(55,877) |
|
|
(46,016) |
|
|
(36,974) |
|
| Marketing and sales |
(124,049) |
|
|
(85,803) |
|
|
(59,445) |
|
| Other Operating Costs |
(248,840) |
|
|
(184,350) |
|
|
(166,788) |
|
| Operating profit / (loss) |
(5,387) |
|
|
18,233 |
|
|
13,561 |
|
| Fair value gain (loss) on revaluation |
(930) |
|
|
(1,185) |
|
|
114 |
|
| Other finance income |
3,663 |
|
|
4,485 |
|
|
14,894 |
|
| Other finance expenses |
(9,069) |
|
|
(5,463) |
|
|
(6,185) |
|
| Finance result, net |
(6,336) |
|
|
(2,163) |
|
|
8,823 |
|
| Share of net profits (loss) in associates using the equity method |
(289) |
|
|
(1,083) |
|
|
694 |
|
| (Loss) / Profit before tax |
(12,012) |
|
|
14,987 |
|
|
23,078 |
|
| Income tax expense |
1,464 |
|
|
(1,313) |
|
|
(7,082) |
|
| (Loss) / Profit for the year |
(10,548) |
|
|
13,674 |
|
|
15,996 |
|
| Basic (loss) / earnings per share ($) |
(0.016) |
|
0.021 |
|
0.025 |
| Diluted (loss) / earnings per share ($) |
(0.016) |
|
0.019 |
|
0.023 |
Comparison of the Year Ended December 31, 2023 and 2022
Revenues
Revenues increased by $39.7 million, or 19.3%, from $205.6 million for the year ended December 31, 2022 to $245.3 million for the year ended December 31, 2023. The increase in revenues was primarily driven by higher sales of RUCONEST® in the U.S. market ($221.2 million and $200.1 million in 2023 and 2022 respectively), which was supported by a price increase below the rate of increase of the Consumer Price Index, as well as an increase in physicians prescribing and the number of patients using RUCONEST®. The increase was also due to the first sales of Joenja®, amounting to $17.9 million in the U.S. market.
Revenues of RUCONEST® in Europe and Rest of World (RoW) amounted to $5.9 million in 2023 compared to $5.5 million in 2022.
Two U.S. customers represent $204.3 million, or 83%, of our net revenues in 2023 , per customer $108.4 million and $95.9 million respectively. In 2022, these two U.S. customers represented $173.6 million, or 84%, of our net revenues, per customer $89.3 million and $84.3 million respectively. These customers are largely specialty wholesale companies that are specialized in distribution of pharmaceuticals in our disease area and distribute our product.
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|
|
| Amounts in US$ ‘000 |
2023 |
|
2022 |
|
|
RUCONEST® |
Joenja® |
Total |
|
RUCONEST® |
Joenja® |
Total |
|
| Revenues: |
|
|
|
|
|
|
|
|
| US |
221,213 |
17,894 |
239,107 |
|
200,082 |
— |
200,082 |
|
| Europe and RoW |
5,921 |
288 |
6,209 |
|
5,540 |
— |
5,540 |
|
| Total revenues |
227,134 |
18,182 |
245,316 |
|
205,622 |
— |
205,622 |
|
| Gross profit: |
|
|
|
|
|
|
|
|
| US |
202,441 |
15,417 |
217,858 |
|
186,263 |
— |
186,263 |
|
| Europe and RoW |
2,026 |
220 |
2,246 |
|
1,797 |
— |
1,797 |
|
| Total gross profit |
204,467 |
15,637 |
220,104 |
|
188,060 |
— |
188,060 |
|
Costs of sales
Costs of sales increased by $7.7 million, or 43.6%, from $17.6 million for the year ended December 31, 2022 to $25.2 million for the year ended December 31, 2023. Costs of sales related to product sales in 2023 amounted to $21.4 million compared to $17.4 million in 2022. This includes royalty fees to Novartis on Joenja® sales, which amounted to $2.1 million in 2023 (2022: $0.0 million). The remainder of costs in 2023 relate to obsolete inventory impairment stems from the valuation of the inventories against lower net realizable value and mainly relates to products no longer eligible for commercial sales. Impairments related to inventories designated for commercial activities amounted to a charge of US$1.7 million in 2023 (2022: US$0.2 million).
The following table summarizes the costs of sales for the years ended December 31, 2023 and 2022.
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|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Cost of inventories recognized as expenses |
(21,404) |
|
|
(17,398) |
|
| Royalty fees |
(2,145) |
|
|
— |
|
| Obsolete inventory impairments |
(1,663) |
|
|
(164) |
|
| Total |
(25,212) |
|
|
(17,562) |
|
Gross profit
Gross profit increased by $32.0 million, or 17.0%, from $188.1 million for the year ended December 31, 2022 to $220.1 million for the year ended December 31, 2023. The main reasons for this increase were higher sales of RUCONEST® and first sales of Joenja®, offset by royalty fees to Novartis related Joenja® and inventory obsolescence impairments.
The following table summarizes the geographical breakdown of our gross profit for the years ended December 31, 2023 and 2022.
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|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
| Amounts in $ ‘000 |
2023 |
|
2022 |
| U.S. |
217,858 |
|
|
186,263 |
|
| Europe and RoW |
2,246 |
|
|
1,797 |
|
| Total gross profit |
220,104 |
|
|
188,060 |
|
Other Income
Other income increased by $8.8 million, or 60.8%, from $14.5 million for the year ended December 31, 2022 to $23.3 million for the year ended December 31, 2023. The increase was primarily due to the proceeds of $21.3 million from the PRV sale. We were granted the PRV by the FDA in March 2023 in connection with the approval of Joenja®.
The sale price was a contractually defined percentage of the PRV value pursuant to the terms of the August 2019 exclusive license agreement between Pharming and Novartis for leniolisib. In 2022 we reduced our minority stake in BioConnection from 43.85% to 22.98%. As a result of this transaction, we recognized a gain in other income in the year ended December 31, 2022 of US$12.2 million.
Cost of research and development
Cost of research and development activities increased by $16.4 million, or 31.2%, from $52.5 million for the year ended December 31, 2022 to $68.9 million for the year ended December 31, 2023. The increase in costs relates mainly to current year’s spend in research and approval of, leniolisib for the treatment of APDS. The cost increase also relates to clinical trials for APDS patients under 12 years old and research on the use of leniolisib for additional PIDs beyond APDS. Primarily due to these costs, both the direct operating expenses and the employee costs have increased in 2023.
Cost of general and administrative activities
Cost of general and administrative activities increased by $9.9 million, or 21.4%, from $46.0 million for the year ended December 31, 2022 to $55.9 million for the year ended December 31, 2023. The increased costs are mainly related to the increased employee costs resulting from more staff employed following the growth of the organization. The increase in impairment losses is mainly related to revised recoverable amount calculations, taking into account decreased expected annual sublease prices for impaired assets such as our cancelled downstream production capacity at Pivot Park in Oss, the Netherlands.
Cost of marketing and sales activities
Cost of marketing and sales activities increased by $38.2 million, or 44.6%, from $85.8 million for the year ended December 31, 2022 to $124.0 million for the year ended December 31, 2023. The increased costs are mainly related to the further expansion of the commercial organization and infrastructure in the U.S., Europe and other key global launch markets, in view of the FDA approval of Joenja® in March 2023 and the anticipated approval by other regulatory authorities in 2024. In addition, we have paid $10.4 million in Development and Regulatory Milestones payments to Novartis as a result of the first commercial sale of Joenja® in 2023, which is recorded as direct operating expenses.
Employee benefits
Employee benefits are included in research and development costs, general and administrative costs, and marketing and sales costs based on the nature of the services provided by each employee. Hence, the employee benefits are not presented in the Consolidated Statement of Income as a separate line-item but are separately disclosed in the Notes to the Annual Financial Statements.
Employee benefits increased by $24.2 million, or 35.4%, from $68.3 million for the year ended December 31, 2022 to $92.5 million for the year ended December 31, 2023. The increase was primarily driven by total salary expense as a result of total number of full time employees increased to 382 in 2023 from 332 in 2022 .
The following table summarizes employee benefits for the years ended December 31, 2023 and 2022.
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|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Salaries |
(71,690) |
|
|
(53,328) |
|
| Social security costs |
(8,604) |
|
|
(6,317) |
|
| Pension costs |
(2,980) |
|
|
(2,284) |
|
| Share-based compensation |
(9,251) |
|
|
(6,392) |
|
| Total |
(92,525) |
|
|
(68,321) |
|
Fair value gain (loss) on revaluation
Fair value losses on revaluation decreased by $0.3 million, or 21.5%, from $1.2 million in 2022 to $0.9 million in 2023, this relates to investment in debt instruments designated as Fair Value Through Profit or Loss or FVTPL.
Other finance income
Other finance income decreased by $0.8 million, or 18.3%, from $4.5 million for the year ended December 31, 2022 to $3.7 million for the year ended December 31, 2023. This decrease was primarily caused by fluctuations in the U.S. dollar versus Euro during 2023 and 2022. This had a particular impact on the bank balances in U.S. dollars, incorporated in our Dutch entities where the functional currency is Euro.
The decrease was offset by an increase interest income. From 2023, excess cash was used to purchase euro denominated readily convertible S&P AAA-rated government treasury certificates with a maturity of six months or less from the date of acquisition. As a result of these purchases and generally increased interest rates, the interest income has increased significantly compared to 2022.
The following table summarizes our other finance income for the years ended December 31, 2023 and 2022.
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|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Interest income |
3,663 |
|
|
85 |
|
| Foreign currency gains |
— |
|
|
4,400 |
|
| Other financial income |
3,663 |
|
|
4,485 |
|
Other finance expenses
Other finance expenses increased by $3.6 million, or 66.0%, from $5.5 million for the year ended December 31, 2022 to $9.1 million for the year ended December 31, 2023. This increase was primarily caused by fluctuations in the U.S. dollar versus Euro
The following table summarizes our other finance expenses for the years ended December 31, 2023 and 2022.
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Interest loans and borrowings |
(4,876) |
|
|
(4,736) |
|
| Interest leases |
(1,088) |
|
|
(622) |
|
| Other financial expenses |
(134) |
|
|
(105) |
|
| Foreign currency losses |
(2,971) |
|
— |
|
— |
|
| Other financial expenses |
(9,069) |
|
|
(5,463) |
|
Share of net profits (loss) in associates using the equity method
Share of net profits (loss) in associates using the equity method increased by $0.8 million, or 73.3%, from a $1.1 million loss for the year ended December 31, 2022 to a $0.3 million loss for the year ended December 31, 2023. This is the result of increased profits from BioConnection.
Income tax expense
Income tax expense decreased by $2.8 million,, from $1.3 million for the year ended December 31, 2022 to $(1.5) million for the year ended December 31, 2023. A lower profit before tax decreased income tax expenses by $7.0 million. The remaining difference is mainly caused by a decrease in non-taxable income of $2.7 million.
The following table summarizes Pharming’s income tax expense for the years ended December 31, 2023 and 2022.
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Total current tax expense |
(5,102) |
|
|
(3,770) |
|
| Total deferred tax expense |
6,566 |
|
|
2,457 |
|
| Income tax expense |
1,464 |
|
|
(1,313) |
|
Comparison of the Year Ended December 31, 2022 and 2021
Revenues
Revenues increased by $6.8 million, or 3.4%, from $198.9 million for the year ended December 31, 2021 to $205.6 million for the year ended December 31, 2022. The increase in revenues was primarily a result of higher sales of RUCONEST® in the U.S. market ($200.1 million and $193.4 million in 2022 and 2021 respectively). From the second quarter onwards, we experienced quarter-on-quarter growth in 2022, both in volumes and revenues, with a growing number of patients using RUCONEST®.
Revenues in Europe and Rest of World (RoW) remained stable at $5.5 million in 2022 from $5.4 million in 2021 in spite of facing strong prophylactic and generic competition.
Two U.S. customers (namely specialty wholesale companies) represent $173.6 million, or 84%, of our revenues in 2022. In 2021, the two U.S. customers represented $156.6 million, or 79%, of our revenues. These wholesale companies are specialized in distribution of pharmaceuticals in distribution of pharmaceuticals in the HAE disease.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
| Amounts in $ ‘000 |
2022 |
|
2021 |
|
| US |
200,082 |
|
|
193,419 |
|
|
| Europe and RoW |
5,540 |
|
|
5,452 |
|
|
| Total revenues |
205,622 |
|
|
198,871 |
|
|
Costs of sales
Costs of sales decreased by $3.6 million, or 16.9%, from $21.1 million for the year ended December 31, 2021 to $17.6 million for the year ended December 31, 2022. Costs of sales in 2022 and 2021 amounted to $17.4 million and $19.1 million. The remainder of costs in 2022 ($0.2 million) stems from obsolescence of inventory impairment charges on inventory designated for commercial activities. These impairment charges amounted to $2.0 million in 2021.
The following table summarizes the costs of sales for the years ended December 31, 2022 and 2021.
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
| Amounts in $ ‘000 |
2022 |
|
2021 |
| Costs of sales |
(17,398) |
|
|
(19,107) |
|
| Obsolescence inventory impairments |
(164) |
|
|
(2,035) |
|
| Total |
(17,562) |
|
|
(21,142) |
|
Gross profit
Gross profit increased $10.3 million, or 5.8%, from $177.7 million for the year ended December 31, 2021 to $188.1 million for the year ended December 31, 2022. The main reasons for this increase were the increase in sales prices, a favorable currency translation effect and favorable production results.
The following table summarizes the geographical breakdown of our gross profit for the years ended December 31, 2022 and 2021.
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
| Amounts in $ ‘000 |
2022 |
|
2021 |
| U.S. |
186,263 |
|
|
176,266 |
|
| Europe and RoW |
1,797 |
|
|
1,463 |
|
| Total gross profit |
188,060 |
|
|
177,729 |
|
Other Income
Other income increased significantly by $11.9 million, or 454.3%, from $2.6 million for the year ended December 31, 2021 to $14.5 million for the year ended December 31, 2022 as Pharming reduced its minority stake in BioConnection from 43.85% to 22.98% in April 2022. As a result of this transaction, Pharming has recognized a gain of $12.2 million. This is partly offset by a decrease in government grants on R&D projects, caused by Pharming’s renewed strategy and pipeline.
Cost of research and development
Operating expenses for research and development decreased by $17.8 million, or 25.3%, from $70.4 million for the year ended December 31, 2021 to $52.5 million for the year ended December 31, 2022. The decrease in costs relates mainly to reduced share-based compensation cost and the impact of the U.S. dollar-EUR FX rate on payroll cost. Current year’s spend in leniolisib, for the treatment of APDS were higher compared to 2021. AKI and cattle costs were also higher in 2022 because of additional incurred costs associated with the discontinuation of the program. This was offset by the investment to in-license OTL-105 and impairment losses of $5.0 million on intangible assets related to the development of RUCONEST® in a more convenient form for patients in 2021.
Cost of general and administrative activities
Cost of general and administrative activities increased by $9.0 million, or 24.5% from $37.0 million for the year ended December 31, 2021 to $46.0 million for the year ended December 31, 2022. The increased costs are mainly related to the increased employee costs resulting from more staff employed, higher cost for audit, consultancy and tax advisers, and higher IT operating spend for our newly implemented ERP system, offset by lower impairment losses in relation to the cancellation of our downstream production capacity at Pivot Park in Oss.
Cost of marketing and sales activities
Cost of marketing and sales activities increased $26.4 million, or 44.3% from $59.4 million for the year ended December 31, 2021 to $85.8 million for the year ended December 31, 2022. The increased costs are mainly related to the further expansion of the commercial organization and infrastructure in both the U.S.A. and Europe, in view of the anticipated launch of leniolisib in APDS upon approval by regulatory authorities.
Employee benefits
Employee benefits are included in research and development costs, general and administrative costs, and marketing and sales costs based on the nature of the services provided by each employee. Hence, the employee benefits are not presented in the Consolidated Statement of Income as a separate line-item but are separately disclosed in the Notes to the Annual Financial Statements.
Employee benefits increased by $7.6 million, or 12.5%, from $60.8 million for the year ended December 31, 2021 to $68.3 million for the year ended December 31, 2022. The increase was primarily driven by total salary expense as a result of total number of full time employees increased to 332 in 2022 from 285 in 2021.
The following table summarizes employee benefits for the years ended December 31, 2021 and 2022.
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2022 |
|
2021 |
| Salaries |
(53,328) |
|
|
(44,202) |
|
| Social security costs |
(6,317) |
|
|
(5,318) |
|
| Pension costs |
(2,284) |
|
|
(2,179) |
|
| Share-based compensation |
(6,392) |
|
|
(9,055) |
|
| Total |
(68,321) |
|
|
(60,754) |
|
Fair value gain (loss) on revaluation
Fair value losses on revaluation increased by $1.3 million or 1139.5%. In 2022 the fair value loss of $1.2 million relates the investment in debt instruments designated as FVTPL while in 2021 the gain of $0.1 million is associated with derivatives designated as financial instruments at FVTPL.
Other finance income
Other finance income decreased by $10.4 million, or 69.9%, from $14.9 million for the year ended December 31, 2021 to $4.5 million for the year ended December 31, 2022. This decrease was primarily caused by fluctuations in the U.S. dollar versus Euro during 2022 and 2021. This had a particular impact on the bank balances in U.S. dollars, incorporated in our Dutch entities where the functional currency is Euro.
The following table summarizes our other finance income for the years ended December 31, 2022 and 2021.
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2022 |
|
2021 |
| Interest income |
85 |
|
53 |
|
| Foreign currency results |
4,400 |
|
14,841 |
|
| Other financial income |
4,485 |
|
14,894 |
|
Other finance expenses
Other finance expenses decreased by $0.7 million, or 11.7%, from $6.2 million for the year ended December 31, 2021 to $5.5 million for the year ended December 31, 2022. This decrease is caused by currency translation effects of $0.7 million on the interest expense on the convertible bond and leases.
The following table summarizes our other finance expenses for the years ended December 31, 2022 and 2021.
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2022 |
|
2021 |
| Interest loans and borrowings |
(4,736) |
|
|
(5,296) |
|
| Interest leases |
(622) |
|
|
(795) |
|
| Other financial expenses |
(105) |
|
|
(94) |
|
| Other financial expenses |
(5,463) |
|
|
(6,185) |
|
Share of net profits (loss) in associates using the equity method
Share of net profits (loss) in associates using the equity method decreased $1.8 million, or 256.1%, from $0.7 million gain for the year ended December 31, 2021 to a $1.1 million loss for the year ended December 31, 2022. This is the result of decreased profits from BioConnection B.V.
Income tax expense
Income tax expense decreased by $5.8 million, or 81.5%, from $7.1 million for the year ended December 31, 2021 to $1.3 million for the year ended December 31, 2022. A lower profit before tax decreased income tax expenses by $1.9 million. The remaining decrease is mainly caused by an increase in non-taxable income of $2.3 million.
The following table summarizes Pharming’s income tax expense for the years ended December 31, 2022 and 2021.
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2022 |
|
2021 |
| Total current tax expense |
(3,770) |
|
|
(1) |
|
| Total deferred tax credit (expense) |
2,457 |
|
|
(7,081) |
|
| Income tax credit (expense) |
(1,313) |
|
|
(7,082) |
|
Key Business and Non-GAAP Financial Measures
The success of Pharming is reflected in its operating and financial track record to date. We use EBIT, EBITDA, Adjusted EBITDA, Net Debt, and Operating Profit as measures to evaluate and manage our business on an ongoing basis. We believe these measures to be useful for investors to compare key financial data both within and across reporting periods. Specifically, we believe that EBIT, EBITDA, and Adjusted EBITDA provide investors with a supplemental measure of our operating performance and highlight trends in our core business that may not otherwise be apparent when relying solely on IFRS measures. Moreover, we believe that inclusion of Net Debt is appropriate to provide investors information on our ability to meet debt obligations by using cash and cash equivalents.
Some of these measures are not calculated in accordance with IFRS and we collectively refer to these as non-GAAP financial measures. These are defined as follows:
•EBIT – Earnings before interest and tax. Defined as profit for the year adjusted to exclude income tax (expense) and financial cost, net.
•EBITDA – Earnings before interest, tax, depreciation and amortization. Defined as profit for the year adjusted to exclude income tax (expense), financial cost, net and depreciation of property, plant and equipment and amortization of intangible assets.
•Adjusted EBITDA – Defined as profit for the year adjusted to exclude income tax (expense), financial gain (cost), net, depreciation of property, plant and equipment, amortization of intangible assets and impairments of certain capitalized development expenses as defined.
•Net Debt – Defined as current and non-current convertible bonds minus cash and cash equivalents minus current and non-current restricted cash and minus marketable securities
To provide investors with additional information regarding our financial results we have provided a reconciliation below of EBIT, EBITDA and Adjusted EBITDA to profit for the year, the most directly comparable IFRS financial measure.
We have included EBIT, EBITDA, and Adjusted EBITDA in our Annual Report because we believe these measures are useful for investors to compare key financial data both within and across reporting periods. Specifically, we believe that these measures provide investors with a supplemental measure of our operating performance and highlights trends in our core business that may not otherwise be apparent when relying solely on IFRS measures. In particular, the exclusion of certain expenses in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our core business.
Our use of EBIT, EBITDA and Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under IFRS. Some of these limitations are:
•Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements;
•They do not reflect changes in, or cash requirements for, our working capital needs;
•They do not reflect tax payments that may represent a reduction in cash available to us; and
•Other companies, including companies in our industry, may calculate these measures differently, which reduces its usefulness as a comparative measure.
The table below presents a reconciliation of the non-GAAP measures to the measures disclosed in our Annual Report for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Profit for the year |
(10,548) |
|
|
13,674 |
|
|
15,996 |
|
| Income tax credit (expense) |
1,464 |
|
|
(1,313) |
|
|
(7,082) |
|
| Financial (cost)/income, net |
(6,336) |
|
|
(2,163) |
|
|
8,823 |
|
| EBIT |
(5,676) |
|
|
17,150 |
|
|
14,255 |
|
Add: Depreciation & amortization |
7,346 |
|
|
6,305 |
|
|
6,390 |
|
| EBITDA |
1,670 |
|
|
23,455 |
|
|
20,645 |
|
Add: Impairment(1) |
4,916 |
|
|
4,376 |
|
|
10,438 |
|
| Adjusted EBITDA |
6,586 |
|
|
27,831 |
|
|
31,083 |
|
(1) The impairment charge in 2023 of $4.9 million primarily consists of impairment charges related to Right-of-Use assets of $4.7 million and intangible assets of $0.3 million. The impairment charge in 2022 of $4.4 million primarily consists of impairment charges related to Right-of-Use Asset for the downstream facility in Oss of $3.9 million. The impairment charge in 2021 of $10.4 million consists of impairment charges of $5.4 million related to the cancellation of the downstream facility is Oss and $5.0 million related to a halted development program for a new form variant of RUCONEST® and a deprioritized development track of alpha-galactosidase for Fabry’s disease. For further details, refer to Note 9, 10 and 11 in the Annual Financial Statements included elsewhere in this Annual Report.
To provide investors with additional information regarding our financial results, we have disclosed in the table below Net Debt, a non-GAAP financial measure. We have provided a reconciliation below of Non-current convertible bonds to net debt, the most directly comparable IFRS financial measure. Net debt is a useful indicator of the Company’s indebtedness, financial flexibility and capital structure because it indicates the level of debt after taking account of cash and cash equivalents and marketable securities within the Company’s business that could be utilized to pay down the outstanding borrowings.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Non-current convertible bonds |
136,598 |
|
|
131,618 |
|
|
139,007 |
|
| Add: Current convertible bonds |
1,824 |
|
|
1,768 |
|
|
1,879 |
|
| Less: Cash and cash equivalents |
(61,741) |
|
|
(207,342) |
|
|
(191,924) |
|
| Less: Marketable securities |
(151,683) |
|
|
— |
|
|
— |
|
| Less: Current and non-current restricted cash |
(1,528) |
|
|
(1,312) |
|
|
(1,039) |
|
Net Debt (2) |
(76,530) |
|
|
(75,268) |
|
|
(52,077) |
|
(2) Discounted value as per the balance sheet.
B. Liquidity and Capital Resources
Liquidity and Capital Resources
Cash and cash equivalents (excluding restricted cash) and marketable securities amounted to $213.4 million, as at December 31, 2023. We have financed our operations primarily through sales of our commercial products and the proceeds of debt and equity offerings. We expect that our marketing and sales, research and development and general and administrative costs will increase for the foreseeable future as we continue commercializing our approved products and advancing the clinical development of our product candidates. We expect that our research and development and sales, general and administrative costs will increase in connection with conducting clinical trials for our product candidates and any new product candidates we acquire or develop and due to the costs of seeking marketing approval for our product candidates in Europe, the United States and other jurisdictions.
The 2023 year-end balance of cash and cash equivalents (excluding restricted cash) and marketable securities of $213.4 million is expected to fund our operations for more than twelve months from the date of this report.
The receipts from commercial supply of product to our partners in Latin America, South Korea and Israel and proceeds from direct sales in the United States and Europe currently generate more cash than we require for day-to-day expenses and to supply those sales, and thus the surplus cash generated will support our capital expenditure plans and financial reserves further.
Presently, however, no further assurance can be given on either the timing or size of future profits or whether consistent net profitability can be maintained on this basis. In addition, in the event that we need to raise capital by issuing additional shares, shareholders’ equity interests may be diluted as to voting power, and their interests as to value will depend on the price at which such issues are made. We see no further need to raise capital to support our current operations, but may take an opportunity to do so in either equity issue, through an expansion of the current convertible debt or to raise debt, or through a combination of such instruments, to support an acquisition or in-licensing of additional assets, if appropriate terms can be obtained that are in the best interests of shareholders.
Cash Flows
The table below provides selected cash flow information for the years ended December 31, 2023, 2022 and 2021.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $’000 |
2023 |
|
2022 |
|
2021 |
| Net cash flows generated from (used in) operating activities |
(17,302) |
|
|
22,458 |
|
|
37,842 |
|
| Net cash flows generated from (used in) investing activities |
(129,388) |
|
|
5,323 |
|
|
(21,305) |
|
| Net cash flows generated from (used in) financing activities |
(1,039) |
|
|
(4,982) |
|
|
(27,947) |
|
| Exchange rate effects |
2,128 |
|
|
(7,381) |
|
|
(1,825) |
|
| Net change in cash and cash equivalents |
(145,601) |
|
|
15,418 |
|
|
(13,235) |
|
Operating Activities
Net cash flows used in operating activities was $17.3 million for the year ended December 31, 2023, compared to net cash flows generated from operating activities of $22.5 million for the year ended December 31, 2022. The decrease of $39.8 million was mainly related to a decrease in profit before tax of $27.0 million and a negative impact of changes in non-cash adjustments related to the gain on disposal from the PRV sale of $21.3 million, partially offset by the gain on disposal of investment in associate of $12.2 million in 2022 and a significant decrease in working capital of $16.6 million.
Net cash flows generated from operating activities was $22.5 million and $37.8 million for the years ended December 31, 2022 and 2021. The decrease of $15.4 million was mainly related to a decrease in profit before tax of $8.1 million and a negative impact of changes in non-cash adjustment of $10.7 million, partially offset by a favorable impact of working capital changes of $4.6 million.
Investing Activities
Net cash flows used in investing activities for the year ended December 31, 2023 was $129.4 million, compared to net cash flows generated from investing activities of $5.3 million for the year ended December 31, 2022. The decrease of $134.7 million was primarily due to purchases of marketable securities of $382.0 million, offset by proceeds from sale of marketable securities of $232.8 million and a cash inflow of $21.3 million related to proceeds on the PRV sale.
Net cash flows generated from investing activities was $5.3 million and $21.3 million used for the years ended December 31, 2022 and 2021, respectively. This increase of $26.6 million was primarily due to the decrease in capital expenditures from $10.7 million in the year ended December 31, 2021 to an expenditure of $1.4 million for the year ended December 31, 2022. A cash inflow of $7.3 million was recognized in 2022 associated with the disposal of our position in BioConnection.
Financing Activities
We saw net cash flows used in financing activities of $1.0 million for the year ended December 31, 2023, compared to $5.0 million for the year ended December 31, 2022. This change of $3.9 million was primarily related to the settlement of share based compensation awards of $8.1 million during the year. There were no new loans or borrowings in 2023.
We saw net cash flows used in financing activities of $5.0 million for the year ended December 31, 2022, compared to $27.9 million for the year ended December 31, 2021. This change of $23.0 million was primarily related to the absence of contingent consideration as compared to the $25.0 million paid in 2021 related to the acquisition of all North American commercialization rights RUCONEST® from Bausch. This was offset by a decrease of $2.4 million in the amount of equity proceeds and warrants in 2022 versus 2021. There were no new loans or borrowings in 2022.
Sources of Liquidity
Convertible bonds
On January 21, 2020, the Company issued €125 million aggregate principal amount of 3.00% convertible bonds to be due in 2025. The net proceeds of the issue of the bonds were used to redeem the balance of a $51.0 million loan outstanding in full. The remaining balance of the net proceeds is being used to support capital expenditure in relation to the expansion of our commercialization and manufacturing infrastructure and will also serve as a funding for the launch of leniolisib, as well as for additional acquisitions and in-licensing opportunities. The bonds were issued at par and bear interest at a rate of 3.00% per annum payable semi-annually in arrears in equal installments. Unless previously converted, redeemed or purchased and cancelled, the bonds will mature on January 21, 2025. We may use a combination of resources to repay the bond such as cash generated by operating activities, bank financing and bonds. The right mix will be established when we get closer to the maturity date of the bond.
The bonds are convertible into our ordinary shares at an initial conversion price of €2.0028. This initial conversion price is subject to customary adjustment provisions. The number of ordinary shares initially underlying the bonds is 62,412,622. Any adjustment to the conversion price resulting in an increase in the number of conversion shares may require the Company to obtain further authorization from our shareholders to issue shares, grant rights to subscribe for shares and exclude pre-emptive rights. The Company has the option to redeem all of the outstanding bonds together in cash at par plus accrued interest at any time, (a) if, on or after February 13, 2023, the parity value on each of at least 20 trading days in a period of 30 consecutive trading days shall have exceeded 130% of the principal amount, or (b) if, at any time, 85% or more of the aggregate principal amount of the bonds originally issued shall have been previously converted and / or repurchased and cancelled.
The convertible bonds are comprised of two components. The first component is a financial liability, which represents our contractual obligation to deliver cash or another financial asset for payment of interest and principal, if not converted. The second component is an equity instrument as it represents a written call option granting the holder the right, for a specified period of time, to convert it into a fixed number of our ordinary shares.
The fair value of the consideration in respect of the liability components is measured at the fair value of a similar liability that does not have any associated equity conversion option (IFRS 9 paragraph 5.1.1). This is the liability component’s carrying amount at initial recognition.
The equity component is measured at the residual difference between the nominal value and the fair value of a similar liability that does not have any associated equity conversion option (IAS 32 paragraph 31). The original equity component as recorded at initial recognition amounts to $1.6 million.
C. Research and Development, Patents and Licenses, etc.
Full details of our research and development activities and expenditures are given in ''Item 4 - A. Business Overview'' and ''Item 5 - A. Operating Results” of this Annual Report.
D. Trend Information
See “Item 5 - A. Operating Results” of this Annual Report.
E. Critical Accounting Estimates
Our Annual Financial Statements have been prepared in accordance with IFRS as issued by the IASB. In the application of accounting policies, certain judgments, estimates and assumptions about the value of assets and liabilities for which there is no definitive third-party reference were required. The estimates and associated assumptions are based on historical experience and other factors that were considered to be relevant. Actual results may differ from these estimates. These estimates and assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revisions and future periods if the revision affects both current and future periods. For a discussion of the estimates and assumptions used by us in the preparation of our financial statements, see Note 2.5 of our Annual Financial Statements for the year ended December 31, 2023.
Item 6. Directors, Senior Management and Employees
A. Directors and Senior Management
Board Structure
Since December 11, 2020, we have had a one-tier board structure, with a single board of directors consisting of executive directors and non-executive directors. Our Chief Executive Officer, or CEO, serves as our executive director.
Our management team is comprised of our executive directors together with our executive officers and be referred to as the Executive Committee.
Executive Officers and Directors
The following table sets forth information regarding our executive officers and directors, including their ages, as of December 31, 2023. Our executive directors are also executive officers.
|
|
|
|
|
|
|
|
|
|
|
|
| Name |
Age |
Position(s) |
Term Expiring |
| Executive Directors: |
|
|
|
| Sijmen de Vries, MD MBA |
64 |
Chief Executive Officer, Chair Executive Committee |
2025 |
| Executive Officers: |
|
|
|
Anurag Relan, MD |
51 |
Chief Medical Officer |
n/a |
| Jeroen Wakkerman |
54 |
Chief Financial Officer |
n/a |
| Mireille Sanders, MSc |
55 |
Chief Operations Officer |
n/a |
| Stephen Toor |
52 |
Chief Commercial Officer |
n/a |
| Ruud van Outersterp |
59 |
Chief Ethics and Compliance Officer |
n/a |
| Alexander Breidenbach, MBA |
60 |
Chief Business Officer |
n/a |
| Non-Executive Directors: |
|
|
|
Paul Sekhri (6)(9) |
65 |
Chairperson |
Expired September 25, 2023 |
Richard Peters (6)(9) |
61 |
Chairperson |
2027 |
Deborah Jorn, MBA (2)(3) |
65 |
Vice Chairperson |
2025 |
Barbara Yanni (2)(6)(8) |
69 |
Director |
2024 |
Mark Pykett (3)(9) |
60 |
Director |
2024 |
Leonard Kruimer (1)(9) |
57 |
Director |
2025 |
Jabine van der Meijs (2)(3)(5) |
57 |
Director |
2025 |
Steven Baert (4)(6)(7) |
49 |
Director |
2025 |
Notes:
(1) Chair of the Audit Committee
(2) Member of the Audit Committee
(3) Member of the Remuneration Committee
(4) Chair of the Remuneration Committee
(5) Chair of the Corporate Governance Committee
(6) Member of the Corporate Governance Committee
(7) Member of the Remuneration Committee since March 2023
(8) Chair of the Transaction Committee
(9) Member of the Transaction Committee
Executive Directors
Sijmen de Vries, MD MBA. Dr. de Vries has been our Chief Executive Officer (CEO) since 2008. Dr. de Vries was reappointed by the General Meeting of Shareholders held on May 19, 2021 for another four-year, ending at the Annual General Meeting of Shareholders in 2025. Prior to joining Pharming, Dr. de Vries was the CEO of 4-Antibody and Morphochem AG. Dr. de Vries also held senior business and commercial positions at Novartis, Novartis Ophthalmics and at SmithKline Beecham Pharmaceuticals plc. Dr. de Vries holds an MD degree from the University of Amsterdam and an MBA in General Management from Ashridge Management College (UK). Dr. de Vries is also member of the supervisory board of BioConnection Investments B.V. and Non-Executive director of Midatech Pharma plc.
Executive Officers
Anurag Relan, MD. Dr. Relan was appointed Chief Medical Officer (CMO) in 2021. Prior to holding the CMO role, Dr. Relan served as Vice President Clinical Research and Medical Affairs at Pharming. Over the last 18 years at Pharming, Dr. Relan has held several leadership roles within the Company. Prior to his work at Pharming, he was in clinical practice while also teaching medical residents and students. Mr. Relan holds an MD and MPH from the University of California, Los Angeles, and a bachelor’s degree in Economics from the University of California, Berkeley.
Jeroen Wakkerman. Mr. Wakkerman has was appointed Chief Financial Officer (CFO) in 2020. From 2015 to 2020, Mr. Wakkerman served as CFO of Nutreco N.V., a global leader in animal nutrition and aqua feed. Prior to that, Jeroen served as CFO of SHV Energy N.V., as finance director at Calor Gas (UK) and has also held several financial and commercial positions at Unilever and Rabobank. Jeroen holds an MSc degree in Business Economics from the University of Groningen and is a Chartered Treasurer (UK) and a Chartered Management Accountant (UK).
Mireille Sanders, MSc. Ms. Sanders was appointed Chief Operations Officer (COO) in 2020. Between 2019 and 2020, Ms. Sanders served as our Senior Vice President, Operations. From 2016 until 2019, Ms. Sanders served as Head of Clinical Supply Chain Strategic Management and Systems at Janssen Pharmaceuticals, a Johnson & Johnson company. Prior to Janssen, Ms. Sanders held senior positions at MSD/Merck, from 2007 until 2015. She holds an MSc in Chemical Engineering from the Technical University Eindhoven in The Netherlands.
Stephen Toor. Mr. Toor was appointed Chief Commercial Officer (CCO) in 2020. He oversees Pharming’s U.S. and ex-U.S. operations and the company’s expansion to key markets and regions globally. Prior to that, Mr. Toor served as President and General Manager of Pharming Healthcare, Inc., our U.S. subsidiary, and also oversaw the broader Americas region. Mr. Toor has over 28 years’ experience leading and managing commercial operations, brand launches and portfolios (rare disease, biologics and small molecule) in the U.S., Europe and globally. His former companies include Pharmacia/Pfizer, Schering-Plough/Merck and Valeant/Bausch Health Companies. He holds a BA (Hons) in European and American History from the Manchester Metropolitan University in the U.K.
Ruud van Outersterp. Mr. van Outersterp was appointed Chief Ethics & Compliance Officer (CECO) in 2021. He also served as our Company Secretary from April 2020 to April 2022. Prior to joining Pharming, Mr. van Outersterp held several senior leadership positions at ABN AMRO and its predecessors, including the positions of Global Head of Legal and Company Secretary, and as senior legal counsel at the former Dutch aircraft manufacturer Fokker. Mr. van Outersterp is also a member of the supervisory board of a healthcare institution and is a teacher at the Governance Academy in Leusden in The Netherlands. He earned a Master’s in Law from the Vrije Universiteit Amsterdam.
Alexander Breidenbach, MBA. Mr. Breidenbach was appointed Chief Business Officer (CBO) on September 1, 2023. Prior to joining Pharming, Dr. Breidenbach held several senior positions including Chief Business and Chief Development Officer at ACM Biosciences AG, as well as a variety of senior leadership roles at Roche Partnering. Dr. Breidenbach holds a PhD in Biochemistry from the Tierärztliche Hochschule (College of Veterinary Medicine) Hannover, Germany, as well as a Master of Business Administration from ESSEC Paris and Mannheim Business School.
Non-Executive Directors
Paul Sekhri. Mr. Sekhri served as the Chair of our Board of Directors (or the former Board of Supervisory Directors until December 2020) beginning in 2016 and as a director beginning in 2015 up until his term expired as Chairperson on September 25, 2023, after which he left our Board of Directors. He was appointed the President and CEO and Director of vTv Therapeutics, Inc. in August 2022. Prior to joining vTv Therapeutics, Mr. Sekhri served as President and CEO of eGenesis, Inc. in 2019 and also served as President and CEO of Lycera Corp from February 2015 to December 2018. Between April 2014 and January 2015, Mr. Sekhri served as Senior Vice President, Integrated Care at Sanofi. From May 2013 to March 2014, Mr. Sekhri served as Group Executive Vice President, Global Business Development and Chief Strategy Officer for Teva Pharmaceutical Industries Ltd., or Teva. Before joining Teva, Mr. Sekhri spent five years as Operating Partner and Head of the Biotechnology Operating Group at TPG Biotech, the life sciences venture capital arm of TPG Capital. From 2004 to 2009, Mr. Sekhri was Founder, President, and CEO of Cerimon Pharmaceuticals, Inc., or Cerimon. Prior to founding Cerimon, Mr. Sekhri was President and Chief Business Officer of ARIAD Pharmaceuticals, Inc. Previously, Mr. Sekhri spent four years at Novartis, as Senior Vice President, and Head of Global Search and Evaluation, Business Development and Licensing for Novartis Pharma AG. Mr. Sekhri also developed the Disease Area Strategy for Novartis, identifying those specific therapeutic areas upon which the company would focus. His first role at Novartis was as Global Head, Early Commercial Development. Mr. Sekhri completed graduate work in Neuroscience at the University of Maryland School of Medicine, where he also received his BS in Zoology. Currently, he is Chair of the Board of Directors of Compugen Ltd. and Longboard Pharmaceuticals, and is on the Board of Axcella Therapeutics, eGenesis, Inc., Ipsen S.A., Spring Discovery, Inc., Veeva Systems, Inc. and Oryn Therapeutics. As an avid classical music enthusiast, Mr. Sekhri is on the Boards of the Metropolitan Opera, the Knights, and is the new Chair of the Board of Young Concert Artists.
Richard Peters. Dr. Peters was appointed the Chairman of the Board of Directors effective upon departure of Mr. Sekhri on September 25, 2023. Dr. Peters has over 30 years of experience in the healthcare industry and academia. He also serves as Non-Executive Director for Kineta and Chairman of the Board of and Chair of the Compensation Committee of Aprea Therapeutics, and is the founder and Executive Chairman of TellBio. He is also a corporate advisor to Aura Biosciences. Prior to these roles, Dr. Peters served as the Global Head for the Rare Diseases business at Sanofi Genzyme, and CEO of two Nasdaq-listed biotechnology companies: Yumanity Therapeutics and Merrimack Pharmaceuticals. Earlier in his career, Dr. Peters held medical leadership positions at Amgen, Onyx Pharmaceuticals, Genzyme, and Sanofi, and is a founder of X4 Therapeutics and PIC Therapeutics. He has also served on the faculty at the Massachusetts General Hospital, served as editor for the journals SCIENCE and JAMA, and has published over 100 editorial and research articles. Dr. Peters completed Internal Medicine training at the Massachusetts General Hospital and a Howard Hughes post-doctoral fellowship at Harvard Medical School; both in Boston, MA. Dr. Peters holds an M.D. Degree and a PhD in Pharmacology from the Medical University of SC, Charleston, South Carolina, and began his medical studies at the Universite Catholique de Louvain in Belgium prior to immigrating to the U.S.
Deborah Jorn, MBA. Ms. Jorn has served as a director since 2019. From 2016 to 2018, she was Executive Vice President of Corporate and Commercial Development at Eyepoint Pharmaceuticals, or Eyepoint. Prior to joining Eyepoint, she was Executive Vice President and Group Company Chair at Bausch Health (formerly Valeant Pharmaceuticals) where she led the dermatology, gastroenterology, and HAE businesses. Ms. Jorn was Chief Global Marketing Officer at Bausch & Lomb prior to its acquisition in 2013 by Bausch Health where she led the launch of several new products and the integration of Ista Pharmaceuticals following acquisition. Previously, she was Group Vice President of Women’s Healthcare and Fertility (2008-2010) and Allergy and Respiratory (2004-2008) at Schering Plough Corporation prior to its acquisition by Merck and Co., Inc., or Merck. Ms. Jorn was also at Johnson & Johnson as the Worldwide Vice President of Internal Medicine and Early Commercial input. She began her career at Merck and for more than 20 years held roles of progressive responsibility in various functional areas including R&D, Regulatory and Sales and Marketing. She served as a member of the Board of Directors of Orexigen Therapeutics, Inc. from May 2016 until July 2018, for Diurnal Group in 2021 and 2022 and for Viveve Medical, Inc. until March 2023.
Barbara Yanni. Ms. Yanni has served as a director since December 2020. Ms. Yanni was Vice President and Chief Licensing Officer at Merck, a pharmaceutical company, from November 2001 until her retirement in March 2014. Prior to this, she served in various roles at Merck including in corporate development, financial evaluation, and tax. Currently, Ms. Yanni serves on the board of directors of two other public biotechnology companies: Trevena, Inc. and Vaccinex, Inc. In addition, from 2021 to 2023 she served on the board of directors of Oncorus, Inc., another public biotechnology company. She is also a member of the board of directors of Mesentech, Inc., a private Canadian biotechnology company. Ms. Yanni earned a J.D. from Stanford Law School and an A.B. from Wellesley College. She also holds a Master of Law in Taxation from New York University. Before joining Merck in 1985 Ms. Yanni was a tax lawyer in New York City.
Mark Pykett. Dr. Pykett has served as a director since December 2020 and is currently President and Chief Executive Officer of the biotechnology company Myrtelle Inc. Previously, he was the Chief Scientific Officer of PTC Therapeutics. Dr. Pykett was the President and CEO of Agilis Biotherapeutics, or Agilis, from 2014 until its acquisition by PTC Therapeutics in 2018. Prior to Agilis, Dr. Pykett served as CEO of Navidea Biopharmaceuticals, President of Alseres Pharmaceuticals, President of Cygenics, and President and CEO of Cytomatrix. Currently, Dr. Pykett serves on the Board of Directors of the private companies Myrtelle, InFlectis BioSciences and Exubrion Therapeutics. He holds a PhD in Molecular Biology from the University of Pennsylvania, a VMD from the University of Pennsylvania School of Veterinary Medicine, a B.A. in Biology from Amherst College, and an MBA from Northeastern University.
Leonard Kruimer. Mr. Kruimer has served as a director since 2021. He has more than 30 years of experience in corporate finance, planning, and strategy, including 20 years in senior executive positions in private and publicly listed biotechnology companies. Mr. Kruimer served as CFO of Crucell N.V., or Crucell, from 1997 to 2011. Prior to Crucell, he was Managing Director of Europe TIP Trailer, a GE Capital company. He was also a consultant with McKinsey & Co. and an auditor at Price Waterhouse & Company, New York. Mr. Kruimer is currently Chair of the Board at Swedish BioInvent International AB. In addition, he is a board member of both Zealand Pharma A/S in Copenhagen and Swiss based Basilea.
Previously, he served as member of the Board of Directors for Calgary-based Oncolytics Biotech Inc. He is Director of AI Global Investments (Netherlands) PCC Ltd. and serves on the Investment Advisory Council of Karmijn Kapitaal. Mr. Kruimer holds a Master of Business Administration from Harvard Business School and is Certified Public Accountant in New York State.
Jabine van der Meijs. Mrs. van der Meijs has served as director since 2021. Prior to this, she served as the Executive Vice President & CFO of the Royal Schiphol Group (2017 - 2021) and worked for the Royal Dutch Shell Group for 25 years in primarily financial leadership positions, but also in HR and strategy positions in The Netherlands, Scotland, England, Brunei, and Australia. In her most recent position at Shell Mrs. van der Meijs, was VP Finance Projects for Shell’s Projects and Technology business. Mrs. van der Meijs is also a Non-Executive Director at V.Group Ltd (since September 1, 2022) and VFS Global AG (since January 1, 2023). Mrs. van der Meijs is a Member of the Supervisory Board of Koole Terminals Holding B.V., a Member of the Board of Directors of Grundfos Holding A/S and a Member of the Supervisory Board of Dutch-based Centre for Human Drug Research (Foundation). Previously, Mrs. van der Meijs served as a Non-Executive Director on various boards, including Kendrion N.V., Aeroports de Paris (France) and Brisbane Airport Corporation.
Mrs. van der Meijs holds a Master of Science (Pharmacy) and a Doctor of Pharmacy (Pharm D) degree from the University of Utrecht, and she completed her professional accounting degree in the U.K. with the Chartered Institute of Management Accountants.
Steven Baert. Mr. Baert has served as a director since 2021. In addition, Mr. Baert is the Chief People Officer and member of the Executive Committee of GE Vernova, the combined power and energy businesses of GE that recently completed a spin and public listing. Prior to this, Mr. Baert was managing director of Propuli LLC, a human capital advisory firm that provided advice to private equity and venture capital clients. From 2006 until 2021, Mr. Baert, worked for Novartis AG and served as Chief People Officer and member of the Executive Committee from 2014 until 2021 and held several leadership roles within that company, including Head of Human Resources for Emerging Growth Markets, Head of Human Resources, United States and Canada, and Global Head, Human Resources, Novartis Oncology. Prior to joining Novartis Oncology, Steven held senior HR positions at Bristol-Myers Squibb Co. and Unilever. Mr. Baert holds a Master of Business Administration from the Vlerick Business School, Gent, a Master of Laws from the Katholieke Universiteit Leuven and a Bachelor of Laws from the Katholieke Universiteit Brussels. Mr. Baert also serves on the Board of WeSeeHope USA, a charity that focuses on empowering children isolated by poverty in Africa.
B. Compensation
Overview of our Remuneration Policy
In accordance with Dutch law, the remuneration packages for the directors and executive officers are determined by the Board of Directors, without the involvement of the executive directors in the deliberations and decision-making concerning their own remuneration. The Board of Directors is authorized to determine the remuneration packages of the executive and non-executive directors in accordance with the remuneration policy that has to be adopted every four years by the General Meeting of Shareholders.
We have updated a remuneration policy that has been aligned with the revised European Union Shareholder Rights Directive, or “SRD II”, and prevailing best practices, which has been approved at a General Meeting of Shareholders. Arrangements in the form of shares or rights to subscribe for shares will each time remain subject to the approval of the shareholders at the General Meeting, notwithstanding the adopted policy.
Our remuneration policy has been designed to support our continuous efforts aimed at improving the overall performance, facilitating growth and sustainable success and enhancing the other long-term value and interests of our Company, providing remuneration packages that are competitive to attract the required executive and non-executive talent and expertise for reaching these objectives in accordance with the long-term strategy.
The remuneration policy is based on the overarching principle that the average level of total remuneration of both the executive directors and officers is consistent with the position of our Company relative to the benchmark groups that are relevant to us. Every two years, an independent consultant makes a market comparison (remuneration benchmark). The peer group each time consists of a group of European and U.S. integrated and commercial stage listed companies active in Life Sciences, reflecting our Company’s operating areas and the markets most relevant in relation to the recruitment and retention of top talent, including the important U.S. market.
EU and U.S. benchmark group:
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|
|
| European peers (2023 and ongoing) |
U.S. peers (2023 and ongoing) |
ADC Therapeutics, Epalinges |
Galapagos, Mechelen |
Anika Therapeutics |
Karyopharm Therapeutics |
Alliance Pharma, Chippenham |
Innate Pharma, Marseille |
BioCryst PharmaCeuticals |
Ligand Pharmaceuticals |
Autolus Therapeutics, London |
Merus, Utrecht |
Coherus BioSciences |
MannKind |
| Basilea Pharmaceutica, Basel |
MorphoSys, Planegg |
Collegium Pharmaceutical |
Mirum Pharmaceuticals |
| Bavarian Nordic, Hellerup |
Oxford Biomedica, Oxford |
Enanta Pharmaceuticals |
Rigel Pharmaceuticals |
| BioGaia, Stockholm |
uniQure, Amsterdam |
Heron Therapeutics |
Supernus Pharmaceuticals |
| Biotest, Dreieich |
Valneva, Saint-Herblain |
ImmunoGen |
Travere Therapeutics |
| Camurus, Lund |
Zealand Pharma, Copenhagen |
Intercept Pharmaceuticals |
Vanda Pharmaceuticals |
| Cosmo Pharmaceuticals, Dublin |
|
Ironwood Pharmaceuticals |
|
A consistent and competitive remuneration structure, which applies across the workforce, is another core principle of our remuneration policy to promote a culture of shared purpose and performance, focusing all executive directors, other executive officers and staff members on delivering on our mission, vision and strategy and creating long-term stakeholder value.
We disclose information regarding remuneration paid to the executive and non-executive directors in our Dutch Annual Report of the Company, in line with the applicable rules and regulations. The remuneration amounts paid to individual executive officers are not required to be disclosed according to Dutch law. Total remuneration paid to all executive officers during the year ended December 31, 2023 was $7.6 million.
Executive Directors and Officers
The remuneration packages of the executive directors and officers consist of:
•Fixed remuneration in the form of an annual base salary;
•Performance-based variable remuneration in the form of:
◦Short-term incentives, in the form of an annual bonus of cash as a percentage of the fixed component, and;
◦Long-term incentives, in the form of the grant of restricted shares; and
•Others benefits, including contribution of pension premiums, travel allowance and holiday allowance.
The respective fixed and variable remuneration elements are explained below:
Historical Remuneration
The following table reflects the remuneration amounts paid to the Executive Director in the year ended December 31, 2023:
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|
|
| Amounts in $ ‘000 |
Fixed remuneration |
|
Short-term variable: annual bonus |
|
Share-based payments |
|
Post-employment benefits |
|
Other |
|
Total |
| Dr Sijmen de Vries, CEO and Executive Director |
673 |
|
615 |
|
1,371 |
|
115 |
|
35 |
|
2,809 |
The short-term variable bonus of $0.6 million in 2023 is based on the 2023 annual salary of $0.7 million, and is paid in 2024. The share-based payment remuneration is based on expenses incurred during the three-year performance period of historic grants, determined at the fair market value at date of the grant, adjusted for changes in the progress of completing strategic objectives.
These strategic objectives are the basis to determine the actual pay-out after the performance period was completed.
The remuneration amounts paid to individual executive officers, other than the above mentioned individual, are not required to be disclosed according to Dutch law and accordingly are not disclosed herein.
Share Option Plan
The following table gives an overview of changes in option holdings of the Executive Director in 2023, the exercise prices and expiration dates:
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|
|
|
January 1, 2023 |
|
Granted 2023 |
|
Exercised in 2023 |
|
Forfeited/Expired in 2023 |
|
December 31, 2023 |
|
Exercise price ($) |
|
Expiration date |
| Dr. Sijmen de Vries |
|
2,800,000 |
|
|
— |
|
|
— |
|
|
— |
|
|
2,800,000 |
|
|
0.886 |
|
|
5/22/2024 |
| Total |
|
2,800,000 |
|
|
— |
|
|
— |
|
|
— |
|
|
2,800,000 |
|
|
|
|
|
Long Term Incentive
The long-term incentive program for the Executive Director, as approved by our shareholders in December 2020, or the Executive LTI plan, is performance-related only. The on-target value of the conditional shares to be awarded to the CEO under the Executive LTI plan annually is set at 300% of the fixed base salary, and maximum performance value of shares is set at 450% of the fixed base salary. The Board of Directors undertakes to ensure equity plans for staff and the Executive Director will be prudently applied and that in any event grants of equity or equity rights under these equity plans will not result in Pharming exceeding 10% of all issued and outstanding shares of Pharming on a diluted basis.
The below table reflects the number of Executive LTI shares granted and vested over the years from 2021 to 2023 for the CEO:
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|
|
Year |
|
Granted |
|
Settled |
|
Forfeited |
|
Unvested |
|
Reserved as at December 31, 2023 |
| Dr. Sijmen de Vries |
|
2023 |
|
1,681,570 |
|
|
— |
|
|
— |
|
|
— |
|
|
1,681,570 |
|
2022 |
|
2,363,455 |
|
— |
|
|
— |
|
|
— |
|
|
2,363,455 |
|
2021 |
|
1,337,888 |
|
— |
|
|
— |
|
|
— |
|
|
1,337,888 |
An overview of the number of Executive LTI shares granted in 2023 and in total as well as the fair value per share award is as follows:
|
|
|
|
|
|
| Participant category |
2023 |
| Executive Members of the Board of Directors |
1,681,570 |
|
| Executive Committee |
4,221,870 |
|
| Total |
5,903,440 |
|
| Fair value per share award ($) |
0.880 |
|
The following table provides an overview of Executive LTI shares granted, forfeited or issued from 2020 to 2023 as well as the number of Executive LTI shares reserved at December 31, 2023:
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|
|
|
|
|
|
|
| Participant category |
Granted |
|
Issued |
|
Forfeited / Unvested |
|
Reserved at December 31, 2023 |
| Executive Members of the Board of Directors |
5,382,913 |
|
0 |
|
0 |
|
5,382,913 |
|
| Executive Committee |
16,444,353 |
|
(1,261,595) |
|
(3,708,270) |
|
11,474,488 |
|
| Senior managers |
1,742,500 |
|
(36,654) |
|
(1,052,346) |
|
|
653,500 |
|
| Total |
23,569,766 |
|
|
(1,298,249) |
|
|
(4,760,616) |
|
|
17,510,901 |
|
Remuneration Policy for Executive Directors and Officers
Fixed Compensation
The following table reflects the gross annual base salary (fixed remuneration) of the Executive Director/CEO paid in the financial year 2023:
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| Position |
|
Fixed remuneration amount ($ ‘000) |
Fixed remuneration amount (EUR ‘000) |
| CEO |
|
673 |
624 |
Variable Compensation
The variable part of the remuneration of the executive directors and officers is linked to their performance against a set of financial and non-financial targets that is consistent with and supportive of the strategy and long-term interests of our Company. Risk alignment is also embedded in the target setting to promote sound and effective risk management. At the end of the relevant performance period, the Board of Directors, without the participation of the executive directors for their performance, will determine whether the targets have been achieved.
Short-term Incentive
The individual on-target bonus for the CEO has been set at 70% of the gross annual salary and for other executive directors and officers at 50% of the gross annual salary. A maximum on-target bonus of 140% of the gross annual salary applies to both the CEO and the executive officers.
Long-term Incentive
Executive directors and officers will also participate in the revised (Executive) Long-term Incentive, or LTI, program. Under this program, our ordinary shares are granted, subject to the achievement of predefined long-term strategy oriented performance objectives and targets, which apply a defined weighting, that have been set at the start of a three-year performance period. The performance objectives include the Total Shareholder Return (40% weighing) and the achievement of long-term strategy oriented objectives (60% weighing). The peer group used to determine the Total Shareholder Return is composed of the companies included in the AScX Index and the NASDAQ Biotechnology Index, represented by the IBB ETF, respectively, equally weighted.
For the executive directors, the on-target value of the (restricted) shares to be awarded under the LTI at the start of the performance period is set at 300% of the gross annual salary for the CEO and 200% for the other executive directors and officers. The maximum value of the shares that can vest under the LTI is set at 450% of the gross annual salary for the CEO and 300% for other executive directors and officers. Executive directors are required to retain the shares awarded under the LTI for a minimum of five years from the date of grant. The Board of Directors undertakes to ensure equity plans for staff and the Executive Director will be prudently applied and that in any event grants of equity or equity rights under these equity plans will not result in Pharming exceeding 10% of all issued and outstanding shares of Pharming on a diluted basis.
Non-executive directors
The remuneration of the non-executive directors is fixed and not linked to the performance of our Company to ensure independence in the discharge of their supervisory tasks and responsibilities, in accordance with prevailing best practices. Until 2020, the members of the former Board of Supervisory Directors (the non-executive directors as of December 11, 2020) were entitled to participate in the Company’s LTIP scheme. From 2020 and onwards, the members of the former Board of Supervisory Directors will no longer participate in the LTIP.
Historical Remuneration of our non-executive directors
The below table provides an overview of the remuneration paid to the non-executives members of the former Board of Supervisory Directors, to the extent still in office, for the year ended December 31, 2023 . Note that the dollar compensation was translated using a yearly average exchange rate applicable for the year, which was was 1.0790 and 1.0543 in 2023 and 2022, respectively.
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| Amounts in $ ‘000 |
Year |
|
Cash |
|
Share-Based Payment |
|
Total |
| Dr. Richard Peters |
2023 |
|
26 |
|
|
20 |
|
|
46 |
|
|
2022 |
|
— |
|
|
— |
|
|
— |
|
|
2021 |
|
— |
|
|
— |
|
|
— |
|
| Mr. Paul Sekhri |
2023 |
|
55 |
|
|
32 |
|
|
87 |
|
|
2022 |
|
72 |
|
|
42 |
|
|
114 |
|
|
2021 |
|
77 |
|
55 |
|
132 |
| Ms. Deborah Jorn |
2023 |
|
55 |
|
|
32 |
|
|
87 |
|
|
2022 |
|
55 |
|
|
32 |
|
|
87 |
|
|
2021 |
|
64 |
|
42 |
|
106 |
| Ms. Barbara Yanni |
2023 |
|
62 |
|
|
32 |
|
|
94 |
|
|
2022 |
|
53 |
|
|
32 |
|
|
85 |
|
|
2021 |
|
60 |
|
36 |
|
96 |
| Dr. Mark Pykett |
2023 |
|
55 |
|
|
32 |
|
87 |
|
|
2022 |
|
50 |
|
|
32 |
|
|
82 |
|
|
2021 |
|
57 |
|
36 |
|
93 |
| Ms. Jabine van der Meijs |
2023 |
|
62 |
|
|
32 |
|
94 |
|
|
2022 |
|
57 |
|
|
32 |
|
|
89 |
|
|
2021 |
|
47 |
|
|
24 |
|
|
71 |
|
| Mr. Leonard Kruimer |
2023 |
|
58 |
|
|
32 |
|
90 |
|
|
2022 |
|
57 |
|
|
32 |
|
|
89 |
|
|
2021 |
|
47 |
|
|
24 |
|
|
71 |
|
| Mr. Steven Baert |
2023 |
|
58 |
|
|
32 |
|
90 |
|
|
2022 |
|
55 |
|
|
32 |
|
|
87 |
|
|
2021 |
|
45 |
|
|
24 |
|
|
69 |
|
| Mr. Barrie Ward |
2023 |
|
— |
|
|
— |
|
|
— |
|
|
2022 |
|
— |
|
|
— |
|
|
— |
|
|
2021 |
|
23 |
|
|
20 |
|
|
43 |
|
| Mr. Juergen Ernst |
2023 |
|
— |
|
|
— |
|
|
— |
|
|
2022 |
|
— |
|
|
— |
|
|
— |
|
|
2021 |
|
— |
|
|
6 |
|
|
6 |
|
| Mr. Aad de Winter |
2023 |
|
— |
|
|
— |
|
|
— |
|
|
2022 |
|
— |
|
|
— |
|
|
— |
|
|
2021 |
|
26 |
|
|
21 |
|
|
47 |
|
| Total |
2023 |
|
431 |
|
|
244 |
|
|
675 |
|
|
2022 |
|
399 |
|
|
234 |
|
|
633 |
|
|
2021 |
|
446 |
|
288 |
|
734 |
Remuneration Policy for Non-Executive Directors
The non-executive directors are entitled to the following annual remuneration, taking into consideration their responsibilities and time commitment as members of the Company’s Board of Directors. Non-executive directors receive an annual retainer of €45,000 ($48,555) in cash and €30,000 ($32,370) of unrestricted shares. Our Chair of the Board of Directors receives an annual retainer of €90,000* ($97,110) in cash and €40,000 ($43,160) in unrestricted shares. Share remuneration is valued at the 20-day VWAP preceding the Annual General Meeting of Shareholders, without further restrictions for grant.
* Effective September 25, 2023. Until September 25, 2023: EUR 65,000 (US$ 70.135)
In addition, non-executive directors receive the following committee fees:
• Audit Committee: €3,000 ($3,237) per annum in cash (Chair €9,000 ($9,711));
• Remuneration Committee: €3,000 ($3,237) per annum in cash (Chair €6,000 ($6,474)); and
• Corporate Governance Committee: €3,000 ($3,237) per annum in cash (Chair €6,000 ($6,474)).
• Transaction Committee: €3,000 ($3,237) per annum in cash (Chair €6,000 ($6,474)).
An additional compensation of €1,000 ($1,100) per day may be paid in case of extraordinary activities, as determined by the Chair of the Board of Directors.
The below table provides an overview of the total remuneration paid to the non-executive directors for the year ended December 31, 2023. Note that the dollar compensation was translated using a yearly average exchange rate applicable for the year, which was 1.0790 in 2023.
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
Fixed remuneration |
|
Share-based payment |
| Dr. Richard Peters |
26 |
|
20 |
| Mr. Paul Sekhri |
55 |
|
32 |
| Ms. Deborah Jorn |
55 |
|
32 |
| Ms. Barbara Yanni |
62 |
|
32 |
| Dr. Mark Pykett |
55 |
|
32 |
| Ms. Jabine van der Meijs |
62 |
|
32 |
| Mr. Leonard Kruimer |
58 |
|
32 |
| Mr. Steven Baert |
58 |
|
32 |
The non-executive directors do not have an individual employment contract with us and are not entitled to participate in any benefits offered to management and staff, including but not limited to pension plans. Accordingly, there were no amounts set aside or accrued by us to provide pension, retirement or similar benefits to non-executive directors in the year ended December 31, 2023. No loans or other financial commitments will be made by or on behalf of the Company to any non-executive director.
Share ownership
Executive directors are required to acquire and hold shares in our Company. For the CEO, the value of the shares held in the Company should at least equal 300% of his or her annual base salary. For other executive directors, if any, the value of the shares held in the Company should at least equal 200% of their respective annual base salaries.
All executive directors may decide to accrue their required minimum shareholding over time by the vesting of after-tax performance shares from the LTI, without the requirement for own purchases, provided that the minimum shareholding is reached within five years following first appointment.
In accordance with the DCGC, all shares in the Company held by the non-executive directors shall be a long-term investment.
Change of control
Following a change of control that has been approved by the General Meeting of Shareholders becoming unconditional, the executive directors will be entitled to pro-rata vesting of outstanding but unallocated shares for the performance period that has lapsed at that moment, subject to the achievement of the applicable performance measures and targets. The remaining shares will vest in accordance with the predetermined schedule (i.e. no accelerated vesting) subject to the achievement of the applicable performance measures and targets.
In case of an unsolicited change of control becoming unconditional, share-based incentive plans do not vest automatically as result of the change of control becoming unconditional.
In case of an event resulting in a change of control or in case of the announcement of a proposed formal public offer for the shares in the Company, the Board of Directors, without the participation of the executive directors, can decide to settle the allocated shares for the members of the Board of Directors in cash.
Severance pay
The executive directors are entitled to severance pay, subject to the following conditions in accordance with the DCGC and prevailing Dutch laws and regulations:
•The maximum severance pay is 100% of the fixed annual remuneration;
•Severance pay is not awarded in the event of failure;
•Severance pay that can be classified as variable is not awarded.
Neither fixed nor variable severance pay may be awarded in the following cases:
•If a relationship is terminated early at the executive director’s own initiative, except where this is due to serious culpable conduct or neglect on the part of the Company;
•In the event of serious culpable conduct or gross negligence on the part of the executive director in the performance of his or her role.
Non-executive directors shall resign in accordance with the retirement schedule as adopted by the Board of Directors. No notice period, severance pay or other or termination fees are applicable.
C. Board Practices
For an overview of the foreign private issuer exemptions applicable to our Company, we refer to "Item 16G — Corporate Governance” in this Annual Report.
Committees of our Board of Directors
The Board of Directors has appointed from among its non-executive members an Audit Committee, a Remuneration Committee and a Corporate Governance Committee. The Board of Directors may, from time to time, establish additional committees.
Audit Committee
During the financial year 2023, the Audit Committee consisted of Mr. Kruimer (Chairperson), Ms. Jorn, Ms. Yanni and Ms. van der Meijs. The composition of our Audit Committee is consistent with the best practice provisions of the DCGC and with applicable SEC and Nasdaq regulations. The Audit Committee supports the Board of Directors in monitoring and ensuring the integrity of the Company’s financial reporting. The committee related tasks and responsibilities include, without limitation:
•the supervision and monitoring of the financial accounting process;
•the monitoring of the effectiveness of the Company’s internal management system, internal audit system, and internal risk management and control systems;
•the review of intended material financial disclosures by the Company (including the Annual Report, quarterly results and the related draft press releases);
•the review of disclosures in applicable filings as required by the U.S. Securities Act of 1933, the Exchange Act and their related rules;
•the nomination for (re)appointment or dismissal of the external auditor, the monitoring of the external auditor’s independence and the annual evaluation of the external auditor’s performance;
•the review of the external auditor’s audit plan, management letters and audit report, respectively;
•the monitoring of the Company’s funding, application of information and communication technology by the Company, including risks relating to cybersecurity, and the Company’s tax policy.
•
The Audit Committee met six times in 2023 (2022: six times), either virtually or in person (in the USA on March 14, 2023, and October 25, 2023). The external auditor, Deloitte Accountants B.V. (Deloitte) attended each meeting of the Audit Committee. The CEO and/or the CFO attended all meetings of the Audit Committee as guests.
The Audit Committee is governed by a charter that complies with applicable Nasdaq rules, which charter is available on our website at www.pharming.com. The Audit Committee is governed by a charter that complies with the best practice provisions of the DCGC and applicable NASDAQ rules. The charter was last updated on March 12, 2024.
Remuneration Committee
During the financial year 2023, the Remuneration Committee consisted of Mr. Baert (Chairperson), Ms. Jorn, Dr. Pykett and Ms. Van der Meijs, who was appointed as of March 15, 2023. The composition of our Remuneration Committee is consistent with the best practice provisions of the DCGC and with applicable SEC and Nasdaq regulations.
The Remuneration Committee met five times in 2023 (2022: six times). Two meetings were held in-person, and the remainder were held virtually.
The Remuneration Committee is governed by a charter that complies with the best practice provisions of the DCGC and applicable Nasdaq rules, which charter is available on our website at www.pharming.com. This charter was evaluated in 2023 and the updated charter was approved on March 20, 2024.
Corporate Governance Committee
During the financial year 2023, the Corporate Governance Committee consisted of Ms. Van der Meijs (Chairperson), Mr. Peters (beginning September 25, 2023), Mr. Sekhri (until September 25, 2023), Ms. Yanni and Mr. Baert. The composition of our Corporate Governance Committee is consistent with the best practice provisions of the DCGC and with applicable SEC and Nasdaq regulations. The main tasks performed by the Corporate Governance Committee include monitoring our compliance with the DCGC and corporate governance-related laws and regulations, monitoring and evaluating the functioning of the Board of the Directors, its committees and individual members and the recruitment and selection for nomination of new directors (if applicable).
The Corporate Governance Committee met three times in 2023 (2022: four times), One meeting was held in in-person, and the remainder were held virtually.
The Corporate Governance Committee is governed by a charter that complies with applicable Nasdaq rules, which charter is available on our website at www.pharming.com. The charter was evaluated and the updated charter was approved on March 20, 2024.
D. Employees
Throughout the year 2023, we employed an average full time equivalent of 382 people, compared to 332 and 285 for 2022 and 2021, respectively. The increase in employees in the period from 2021 to 2023 aligns with the growth that the business demonstrated. Our business involves specific high-technology processes and requires the employment of highly skilled and motivated personnel. Therefore, it is important for us to create an attractive work environment that retains and motivates a diverse range of personnel and attracts talent in a competitive and global marketplace. None of our employees are represented by any collective bargaining unit.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Average full time equivalent |
2023 |
|
2022 |
|
2021 |
| The Netherlands |
201 |
|
198 |
|
186 |
| France |
21 |
|
19 |
|
16 |
| Germany |
4 |
|
1 |
|
1 |
| Italy |
2 |
|
1 |
|
0 |
| United Kingdom |
15 |
|
10 |
|
5 |
| United States |
136 |
|
102 |
|
77 |
Spain |
2 |
|
— |
|
|
— |
|
Turkey |
1 |
|
— |
|
|
— |
|
| Total |
382 |
|
332 |
|
285 |
|
|
|
|
|
|
| Average full time equivalent |
|
|
|
|
|
| General and administrative |
104 |
|
69 |
|
60 |
| Research and development |
131 |
|
138 |
|
169 |
| Marketing and sales |
100 |
|
77 |
|
56 |
| Production |
47 |
|
48 |
|
— |
|
| Total |
382 |
|
332 |
|
285 |
E. Share Ownership
The share ownership information with respect to the Board of Directors and Executive Committee is presented in ''Item 7 — A. Major Shareholders'' below.
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 below table sets forth information with respect to the beneficial ownership of our ordinary shares as of March 31, 2024 by:
•each person, or group of affiliated persons, that beneficially owns 5% or more of our outstanding ordinary shares;
•each of our directors and executive officers; and
•all of our directors and executive officers as a group.
Beneficial ownership is determined in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include ordinary shares that can be acquired within 60 days of March 31, 2024. Percentage ownership calculations are based on 673,438,313 ordinary shares issued and outstanding as of March 31, 2024, plus, consistent with SEC rules on disclosure of beneficial ownership, ordinary shares that can be acquired within 60 days of March 31, 2024.
Except as otherwise indicated, all of the ordinary shares reflected in the table are ordinary shares and all persons listed below have sole voting and investment power with respect to the ordinary shares beneficially owned by them, subject to applicable community property laws. The information is not necessarily indicative of beneficial ownership for any other purpose. Unless otherwise indicated in the table below, addresses of the directors, executive officers and named beneficial owners are in care of Pharming Group N.V, Darwinweg 24, 2333 CR Leiden, The Netherlands.
As of March 31, 2024, there was no person known to us to be the beneficial owner of more than five percent (5%) of each class of our common shares issued and outstanding.
The voting rights of our major shareholders do not differ from the voting rights of holders of our common shares who are not major shareholders.
The following table sets forth the number of our issued and outstanding common shares that are held (beneficially owned) by record holders of March 31, 2024:
|
|
|
|
|
|
|
|
|
| Name of Beneficial Owner |
Number of Ordinary Shares Beneficially |
Percentage of Ordinary Shares Beneficially Owned |
| Executive Officers and Executive Directors: |
14,984,557 |
|
2.2% |
| Sijmen de Vries, MD MBA (1) |
11,344,736 |
|
1.7% |
| Mireille Sanders, MSc (2) |
967,770 |
|
* |
| Stephen Toor (3) |
862,700 |
|
* |
| Jeroen Wakkerman (4) |
1,105,844 |
|
* |
| Anurag Relan (5) |
353,000 |
|
* |
| Ruud van Outersterp (6) |
285,157 |
|
* |
Alexander Breidenbach (7) |
65,350 |
|
* |
| Non-Executive Directors: |
685,833 |
|
|
Deborah Jorn, MBA (8) |
135,133 |
|
* |
Barbara Yanni (9) |
119,542 |
|
* |
Mark Pykett (9) |
119,542 |
|
* |
Jabine van der Meijs (10) |
94,704 |
|
* |
Leon Kruimer (10) |
94,704 |
|
* |
Steven Baert (10) |
94,704 |
|
* |
Richard Peters (11) |
27,504 |
|
* |
.
*Represents beneficial ownership of less than one percent.
(1) Consists of 8,544,736 ordinary shares and 2,800,000 exercisable share options held as of March 31, 2024.
(2) Consists of 799,020 ordinary shares and 168,750 exercisable share options held as of 31 March 2024.
(3) Consists of 187,700 ordinary shares and 675,000 exercisable share options held as of March 31, 2024.
(4) Consists of 430,844 ordinary shares and 675,000 exercisable share options held as of 31 March 2024
(5) Consists of 184,500 ordinary shares and 168,750.00 exercisable share options held as of March 31, 2024.
(6) Consists of 165,157 ordinary shares and 120,000 exercisable share options held as of 31 March 2024.
(7) Consists of 65,350 ordinary shares and 0 exercisable share options held as of March 31, 2024.
(8) Consists of 135,133 ordinary shares held as of March 31, 2024.
(9) Consists of 119,542 ordinary shares held as of March 31, 2024.
(10) Consists of 94,704 ordinary shared held as of March 31, 2024.
(11) Consists of 27,504 ordinary shares held as of March 31, 2024.
We estimate that as of March 31, 2024 approximately 9.3% of our outstanding ordinary shares are held by 25 institutional U.S. record holders.
B. Related Party Transactions
We have engaged in the following transactions with our directors, executive officers, holders of more than 10% of our outstanding share capital and their affiliates, and certain entities that we may be deemed to control, which we refer to as our related parties.
Transactions with BioConnection
We enter into transactions with BioConnection, our fill and finish partner, in the ordinary course of business. Following a restructuring in 2022, we are holding a stake of 22.98% in BioConnection. For the years ended December 31, 2023, 2022 and 2021, we paid BioConnection $4.7 million, $3.0 million and $3.5 million respectively, for fill and finish services. At December 31, 2023, the Company was owed $1.7 million from BioConnection for fill and finish services supplied. At December 31, 2022, the Company owed $0.5 million to BioConnection for fill and finish services.
Agreements with Our Executive Officers and Directors
We have entered into management contracts with certain executive officers (including our executive directors), while the other executive officers are employed by us. We have service contracts with certain non-executive directors. These agreements contain customary provisions and representations, including confidentiality, non-competition, non-solicitation and inventions assignment undertakings by the executive officers. However, the enforceability of the non-competition provisions may be limited under applicable law.
Indemnification Agreements
The Articles of Association include an indemnity in favor of all members of our Board of Directors and executive officers. We have entered into indemnity agreements with each of our directors and executive officers, in line with the indemnity included in our Articles of Association. The indemnity agreements and our Articles of Association require us to indemnify our directors and executive officers to the fullest extent permitted by law.
The contract with Dr. de Vries includes a third party indemnity arrangement. The service contracts with our non-executive directors include a general indemnity.
The employment agreements with Mrs. Sanders, Mr. Toor, Mr.Wakkerman and Mr. van Outersterp do not include a contractual indemnity (and third-party liability claims are therefore governed by the applicable law).
Related Party Transactions Policy
We have adopted a related party transaction policy, or the Related Person Policy, requiring that all related party transactions required to be disclosed by a foreign private issuer pursuant to the Exchange Act be approved by our Board of Directors or a designated committee thereof consisting solely of independent directors, including the Audit Committee. Our Board of Directors has also established an internal procedure to periodically assess whether related party transactions (as defined under Dutch law) are entered into in the ordinary course of business and under normal market conditions. In addition, under Dutch law, we are required to disclose material transactions with a related party (as defined under Dutch law and subject to certain exceptions) that were not entered into in the ordinary course of business and/or not under normal market conditions at the time the transaction was entered into and such transactions shall be subject to the approval of our Board of Directors.
In December 2023, the Audit Committee conducted its annual review of the existing related person transactions within the meaning of the Company’s Related Person Policy. The Audit Committee concluded, based on the gathered information, that (i) each of the transactions in scope of that policy was entered into in the ordinary course of business, and (ii) without the involvement of the relevant related persons. Accordingly, the Audit Committee ratified these transactions in accordance with the prevailing policy.
C. Interests of Experts and Counsel
Not applicable.
Item 8. Financial Information
A. Consolidated Statements and Other Financial Information.
Consolidated Financial Statements
Our consolidated financial statements are included at the end of this Annual Report, starting at page F-1. See “Item 17 — Financial Statements” of this Annual Report.
Legal Proceedings
From time to time, we may become involved in litigation or other legal proceedings relating to claims arising from the ordinary course of business.
Currently we are not a party to any material legal or administrative proceedings.
Dividend Distribution Policy
We have never declared or paid any dividends on our ordinary shares since our ordinary shares were listed on Euronext Amsterdam. We intend to retain any earnings for use in our business and do not currently intend to pay dividends on our ordinary shares. We may only pay dividends or distributions from our reserves to the extent our shareholders’ equity (eigen vermogen) exceeds the sum of our paid-up and called-up share capital plus the reserves we must maintain by Dutch law or by our Articles of Association from time to time and (if it concerns a distribution of profits) after adoption of the annual accounts by our general meeting from which it appears that such distribution is allowed. Subject to such restrictions, any future determination to pay dividends or other distribution will be at the discretion of our Board of Directors and will depend upon a number of factors, including our results of operations, cash requirements, financial condition, future prospects, contractual restrictions, any future debt agreements, restrictions under applicable laws and other factors that our Board of Directors may deem relevant.
Under our Articles of Association, our Board of Directors may decide that all or part of our profits shall be added to our reserves and any remaining profit will be at the disposal of the general meeting at the proposal of our Board of Directors for distribution on our ordinary shares, subject to restrictions of Dutch law. Our Board of Directors is permitted, subject to certain requirements, to declare interim dividends without the approval of the general meeting.
B. Significant Changes
None.
Item 9. The Offer and Listing
A. Offer and Listing Details
Since December 22, 2020, our ADSs, each representing ten ordinary shares of Pharming Group N.V., have been quoted on the Nasdaq Global Market under the symbol “PHAR”. Since December 21, 2009, our ordinary shares of Pharming Group N.V. have been quoted on Euronext Amsterdam under the symbol “PHARM”.
B. Plan of Distribution
Not applicable.
C. Markets
Our ADSs, each representing ten ordinary shares of Pharming Group N.V., are listed on the Nasdaq Global Market under the symbol “PHAR”.
Our ordinary shares are currently traded on Euronext Amsterdam under the symbol “PHARM”.
D. Selling Shareholders
Not applicable.
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
A copy of our Amended and Restated Articles of Association is filed as Exhibit 1.1 to this Annual Report. The information called for by this item is set forth in Exhibit 2.1 to this Annual Report and is incorporated by reference into this Annual Report.
C. Material Contracts
Material Agreements
Novartis Development Collaboration and License Agreement
On August 12, 2019, we entered into a License Agreement, or the Novartis License Agreement, with Novartis, pursuant to which Novartis granted to us an exclusive license to develop and commercialize leniolisib. Under the terms of the Novartis License Agreement, the license is exclusive even as to Novartis and its affiliates, and we are permitted to sublicense the exclusive license. Effective May 8, 2020, Novartis merged into Novartis Pharma AG. As a result, all assets and liabilities of Novartis, including the Novartis License Agreement, became assets and liabilities of Novartis Pharma AG.
Under the terms of the Novartis License Agreement, we made an upfront payment of $20 million to Novartis in August 2019. Novartis has completed all the preclinical and clinical work to date and will continue to run the ongoing OLE study. We are commercializing leniolisib under the name Joenja® through our existing commercial infrastructure in the United States and expect to in Europe and other markets worldwide, subject to regulatory approval and as described elsewhere in this Annual Report. Pursuant to the Novartis License Agreement, we agreed to make certain milestone payments to Novartis in an aggregate amount of up to $200 million upon (i) the completion of certain regulatory milestones and (ii) the achievement of certain leniolisib sales milestones. We also agreed to make tiered royalty payments to Novartis, calculated as low double-digit to high-teen percentage of net sales of leniolisib. During 2023, we paid milestone payments to Novartis of $ 10 million.
The Novartis License Agreement will terminate on a licensed product-by-licensed product and country-by-country basis upon the expiration of the royalty term for such licensed product in such country, and will terminate in its entirety upon the expiration of the royalty term with respect to the last licensed product then being developed, manufactured or commercialized in all countries of the territory. The royalty term ends on the last to occur of (i) the expiration of the last to expire valid claim of the licensed patents that covers such licensed product in such country; (ii) the expiration of any regulatory exclusivity for such licensed product in such country; or (iii) the ten (10) year anniversary of the first commercial sale of the licensed product in such country. Either party may terminate the agreement upon a material breach by the other party that is not cured within a specified period after receiving written notice. We have the right to terminate the Novartis License Agreement for any reason upon specified prior written notice to Novartis.
Orchard Research Collaboration and License Agreement
On July 1, 2021, we entered into a strategic collaboration with Orchard, to research, develop, manufacture and commercialize OTL-105, an investigational HSC, gene therapy for the treatment of HAE. Under the terms of the collaboration we were granted worldwide rights to OTL-105 and will be responsible for clinical development, regulatory filings and commercialization of the investigational gene therapy, including associated costs. Orchard will support the completion of IND-enabling activities and oversee manufacturing of OTL-105 during pre-clinical and clinical development, which will be funded by us. In addition, both companies will explore the application of non-toxic conditioning regimen for use with OTL-105 administration. We paid an upfront payment of $17.5 million comprising of $10 million in cash and a $7.5 million equity investment at a premium to Orchard’s share price.
Orchard is also eligible to receive up to $189.5 million in development, regulatory and sales milestones as well as mid-single to low double-digit royalty payments on future worldwide sales.
On January 24, 2024, Kyowa Kirin Co., Ltd., a Japan-Based global specialty pharmaceutical company, completed an acquisition of Orchard. We do not anticipate any negative impact of the acquisition on OTL-105.
D. Exchange Controls
Under the existing laws of The Netherlands, there are no exchange controls applicable to the transfer to persons outside of The Netherlands of dividends or other distributions with respect to, or of the proceeds from the sale of, shares of a Dutch company, subject to applicable restrictions under sanctions and measures, including those concerning export control, pursuant to EU regulations, the Sanctions Act 1977 (Sanctiewet 1977) or other legislation, applicable anti-boycott, anti-money-laundering or anti-terrorism regulations and similar rules. There are no special restrictions in the Articles of Association or Dutch law that limit the right of shareholders who are not citizens or residents of The Netherlands to hold or vote shares.
E. Taxation
MATERIAL INCOME TAX CONSIDERATIONS
The following summary contains a description of material Dutch and U.S. federal income tax considerations of the acquisition, ownership and disposition of our ordinary shares or ADSs. This summary should not be considered a comprehensive description of all the tax considerations that may be relevant to the decision to acquire ADSs representing our ordinary shares.
Material U.S. Federal Income Tax Considerations for U.S. Holders
The following is a description of the material U.S. federal income tax considerations to the U.S. Holders described below of owning and disposing of our ordinary shares or ADSs. It is not a comprehensive description of all tax considerations that may be relevant to a particular person’s decision to acquire securities. This discussion applies only to a U.S. Holder that holds our ordinary shares or ADSs as a capital asset within the meaning of Section 1221 of the Code, for tax purposes (generally, property held for investment). In addition, it does not describe all of the tax considerations that may be relevant in light of a U.S. Holder’s particular circumstances, including state and local tax considerations, any U.S. federal non-income tax considerations such as estate or gift tax considerations, alternative minimum tax considerations, the Medicare contribution tax on net investment income, the special tax accounting rules under Section 451 (b) of the Code, and tax considerations applicable to U.S. Holders subject to special rules, such as:
•banks, insurance companies, and certain other financial institutions;
•U.S. expatriates and certain former citizens or long-term residents of the United States;
•dealers or traders in securities who use a mark-to-market method of tax accounting;
•persons holding ordinary shares or ADSs as part of a hedging transaction, “straddle,” wash sale, conversion transaction or integrated transaction or persons entering into a constructive sale with respect to ordinary shares or ADSs;
•persons whose “functional currency” for U.S. federal income tax purposes is not the U.S. dollar;
•brokers, dealers or traders in securities, commodities or currencies;
•tax-exempt entities or government organizations;
•S corporations, partnerships, or other entities or arrangements classified as partnerships or pass-throughs for U.S. federal income tax purposes (and investors therein);
•tax-qualified retirement plans;
•regulated investment companies, real estate investment trusts, corporations that accumulate income to avoid U.S. federal income tax;
•persons who acquired our ordinary shares or ADSs pursuant to the exercise of any employee stock option or otherwise as compensation;
•persons that own or are deemed to own (including by attribution) ten percent or more of our shares (by vote or value); and
•persons holding our ordinary shares or ADSs in connection with a trade or business, permanent establishment, or fixed base outside the United States.
If an entity or arrangement that is classified as a partnership for U.S. federal income tax purposes holds ordinary shares or ADSs, the U.S. federal income tax treatment of a partner will generally depend on the status of the partner and the activities of the partnership. Partnerships holding ordinary shares or ADSs and partners in such partnerships are encouraged to consult their tax advisers as to the particular U.S. federal income tax considerations of holding and disposing of ordinary shares or ADSs.
The discussion is based on the Code, administrative pronouncements, judicial decisions, final, temporary and proposed Treasury Regulations, and the income tax treaty between The Netherlands and the United States, or the Treaty, all as of the date hereof, changes to any of which may affect the tax consequences described herein—possibly with retroactive effect.
A “U.S. Holder” is a holder who, for U.S. federal income tax purposes, is a beneficial owner of ordinary shares or ADSs who is eligible for the benefits of the Treaty and is:
•an individual who is a citizen or resident of the United States;
•a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the United States, any state therein or the District of Columbia;
•an estate the income of which is subject to U.S. federal income taxation regardless of its source; or
•a trust if (a) a U.S. court is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have authority to control all substantial decisions of the trust or (b) the trust has a valid election to be treated as a U.S. person under applicable U.S. Treasury Regulations.
U.S. Holders are encouraged to consult their tax advisers concerning the U.S. federal, state, local and non-U.S. tax consequences of owning and disposing of our ordinary shares or ADSs in their particular circumstances. The discussion below assumes that the representations contained in the deposit agreement are true and that the obligations in the deposit agreement and any related agreement will be complied with in accordance with their terms. Generally, a holder of an ADS should be treated for U.S. federal income tax purposes as holding the ordinary shares represented by the ADS. Accordingly, no gain or loss will be recognized upon an exchange of ADSs for ordinary shares.
Passive Foreign Investment Company Rules
A non-U.S. corporation will be classified as a PFIC, for any taxable year in which, after applying certain look-through rules, either:
•at least 75% of its gross income is passive income (such as interest income); or
•at least 50% of its gross assets (determined on the basis of a quarterly average) is attributable to assets that produce passive income or are held for the production of passive income (including cash).
•For this purpose, cash is a passive asset and passive income generally includes dividends, interest, royalties and rents (other than royalties and rents derived in the active conduct of a trade or business and not derived from a related person). For purposes of this test, we will be treated as owning our proportionate share of the assets and earning our proportionate share of the income of any other corporation, the equity of which we own, directly or indirectly, 25% or more (by value).
Based on the estimated composition of our income, assets, operations and market capitalization for 2023, we do not believe that we were classified as a PFIC for U.S. federal income tax purposes for the taxable year ending December 31, 2023. However, no assurances can be provided that we will not be a PFIC for the current or any future taxable year or that we have not been a PFIC in any prior taxable years. The determination of whether we are a PFIC is a fact-intensive determination made on an annual basis and the applicable law is subject to varying interpretation. In particular, the characterization of our assets as active or passive may depend in part on our current and intended future business plans, which are subject to change. In addition, for our current and future taxable years, the total value of our assets for PFIC testing purposes may be determined in part by reference to the market price of our ordinary shares or ADSs from time to time, which may fluctuate considerably. Under the income test, our status as a PFIC depends on the composition of our income which will depend on a variety of factors that are subject to uncertainty, including the characterization of certain intercompany payments and payments from tax authorities, transactions we enter into in the future and our corporate structure. Even if we were to determine that we are not a PFIC for a taxable year, there can be no assurance that the IRS would not successfully challenge our position. Accordingly, our U.S. counsel expresses no opinion with respect to our PFIC status for any prior, current or future taxable year.
If we are classified as a PFIC in any year with respect to which a U.S. Holder owns the ordinary shares or ADSs, we will continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding years during which the U.S. Holder owns the ordinary shares or ADSs, regardless of whether we continue to meet the tests described above unless (a) we cease to be a PFIC and the U.S. Holder has made a “deemed sale” election under the PFIC rules, or (b) the U.S. Holder (i) makes a “QEF Election” (defined below) or (ii) is eligible to make and makes a mark-to-market election (as described below), with respect to all taxable years during such U.S. Holder’s holding period in which we are a PFIC. If such a deemed sale election is made, a U.S. Holder will be deemed to have sold the ordinary shares or ADSs the U.S. Holder holds at their fair market value as of the date of such deemed sale and any gain from such deemed sale would be subject to the rules described below. After the deemed sale election, so long as we do not become a PFIC in a subsequent taxable year, the U.S. Holder’s ordinary shares or ADSs with respect to which such election was made will not be treated as shares in a PFIC and the U.S. Holder will not be subject to the rules described below with respect to any “excess distribution” the U.S. Holder receives from us or any gain from an actual sale or other disposition of the ordinary shares or ADSs. U.S. Holders should consult their tax advisers as to the possibility and consequences of making a deemed sale election if we cease to be a PFIC and such election becomes available.
For each taxable year we are treated as a PFIC with respect to U.S. Holders, U.S. Holders will be subject to special tax rules with respect to any “excess distribution” such U.S. Holder receives and any gain such U.S. Holder recognizes from a sale or other disposition (including a pledge) of ordinary shares or ADSs, unless (a) such U.S. Holder makes a “qualified electing fund” election, or QEF Election, with respect to all taxable years during such U.S. Holder’s holding period in which we are a PFIC, or (b) our ordinary shares or ADSs constitute “marketable stock” and such U.S. Holder makes a mark-to-market election (as discussed below). Distributions a U.S. Holder receives in a taxable year that are greater than 125% of the average annual distributions a U.S. Holder received during the shorter of the three preceding taxable years or the U.S. Holder’s holding period for the ordinary shares or ADSs will be treated as an excess distribution. Under these special tax rules:
•the excess distribution or gain will be allocated ratably over a U.S. Holder’s holding period for the ordinary shares or ADSs;
•the amount allocated to the current taxable year, and any taxable year prior to the first taxable year in which we became a PFIC, will be treated as ordinary income; and
•the amount allocated to each other year will be subject to the highest tax rate in effect for that year and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year.
The tax liability for amounts allocated to years prior to the year of disposition or “excess distribution” cannot be offset by any net operating losses for such years, and gains (but not losses) realized on the sale of the ordinary shares or ADSs cannot be treated as capital gains, even if a U.S. Holder holds the ordinary shares or ADSs as capital assets.
If we are a PFIC, a U.S. Holder will generally be subject to similar rules with respect to distributions we receive from, and our dispositions of the stock of, any of our direct or indirect subsidiaries that also are PFICs, as if such distributions were indirectly received by, and/or dispositions were indirectly carried out by, such U.S. Holder. U.S. Holders should consult their tax advisers regarding the application of the PFIC rules to our subsidiaries.
If a U.S. holder makes a QEF Election covering all taxable years during which the holder holds ordinary shares or ADSs and in which we are a PFIC, distributions and gains will not be taxed as described above. If a U.S. Holder makes an effective QEF Election, the U.S. Holder will be required to include in gross income each year, whether or not we make distributions, as capital gains, such U.S. Holder’s pro rata share of our net capital gains and, as ordinary income, such U.S. Holder’s pro rata share of our earnings in excess of our net capital gains. If a U.S. holder makes a QEF Election with respect to us, any distributions paid by us out of our earnings and profits that were previously included in the U.S. holder’s income under the QEF Election would not be taxable to the holder. A U.S. holder will increase its tax basis in its ordinary shares or ADSs by an amount equal to any income included under the QEF Election and will decrease its tax basis by any amount distributed on the ordinary shares or ADSs that is not included in the holder’s income. If a U.S. holder has made a QEF Election with respect to its ordinary shares or ADSs, any gain or loss recognized by the U.S. holder on a sale or other disposition of such ordinary shares or ADSs will constitute capital gain or loss. In addition, if a U.S. holder makes a timely QEF Election, our ordinary shares or ADSs will not be considered shares in a PFIC in years in which we are not a PFIC, even if the U.S. holder had held ordinary shares or ADSs in prior years in which we were a PFIC.
However, a U.S. Holder can only make a QEF Election with respect to ordinary shares or ADSs in a PFIC if such company agrees to furnish such U.S. Holder with certain tax information annually. We do not currently expect to provide such information in the event that we are classified as a PFIC.
If we are a PFIC in any taxable year with respect to which a U.S. Holder owns our ordinary shares or ADSs, such U.S. Holders can avoid the interest charge on excess distributions or gain relating to our ordinary shares or ADSs by making a mark-to-market election with respect to the ordinary shares or ADSs, provided that the ordinary shares or ADSs are “marketable stock.” Ordinary shares or ADSs will be marketable stock if they are “regularly traded” on a “qualified exchange”. For these purposes, the ordinary shares or ADSs will be considered regularly traded during any calendar year during which they are traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. Any trades that have as their principal purpose meeting this requirement will be disregarded. Our ADSs (but not ordinary shares) are listed on the Nasdaq, which is a qualified exchange for these purposes. Consequently, if our ADSs remain listed on the Nasdaq and are regularly traded, we expect the mark-to-market election would be available to U.S. Holders of our ADSs if we are a PFIC. Each U.S. Holder should consult its tax advisor as to whether a mark-to-market election is available or advisable with respect to our ordinary shares or ADSs.
A U.S. Holder that makes a mark-to-market election must include in ordinary income for each year an amount equal to the excess, if any, of the fair market value of our ordinary shares or ADSs at the close of the taxable year over the U.S. Holder’s adjusted tax basis in the ordinary shares or ADSs. An electing holder may also claim an ordinary loss deduction for the excess, if any, of the U.S. Holder’s adjusted basis in the ordinary shares or ADSs over the fair market value of the ordinary shares or ADSs at the close of the taxable year, but this deduction is allowable only to the extent of any net mark-to-market gains for prior years. Gains from an actual sale or other disposition of the ordinary shares or ADSs will be treated as ordinary income, and any losses incurred on a sale or other disposition of the shares will be treated as an ordinary loss to the extent of any net mark-to-market gains for prior years. Once made, the election cannot be revoked without the consent of the IRS unless the ordinary shares or ADSs cease to be marketable stock.
However, a mark-to-market election generally cannot be made for equity interests in any lower-tier PFICs that we own, unless shares of such lower- tier PFIC are themselves “marketable stock.” As a result, even if a U.S. Holder validly makes a mark-to-market election with respect to our ordinary shares or ADSs, the U.S. Holder may continue to be subject to the PFIC rules (described above) with respect to its indirect interest in any of our investments that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. U.S. Holders should consult their tax advisers as to the availability and desirability of a mark-to-market election, as well as the impact of such election on interests in any lower-tier PFICs.
Unless otherwise provided by the U.S. Treasury, each U.S. shareholder of a PFIC is required to file an Annual Report containing such information as the U.S. Treasury may require. A U.S. Holder’s failure to file the Annual Report will cause the statute of limitations for such U.S. Holder’s U.S. federal income tax return to remain open with regard to the items required to be included in such report until three years after the U.S. Holder files the Annual Report, and, unless such failure is due to reasonable cause and not willful neglect, the statute of limitations for the U.S. Holder’s entire U.S. federal income tax return will remain open during such period. U.S. Holders should consult their tax advisers regarding the requirements of filing such information returns under these rules.
Taxation of Distributions
Subject to the discussion above under “Passive Foreign Investment Company Rules,” distributions paid on ordinary shares or ADSs, other than certain pro rata distributions of ordinary shares or ADSs, will generally be treated as dividends to the extent paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Because we may not calculate our earnings and profits under U.S. federal income tax principles, we expect that distributions generally will be reported to U.S. Holders as dividends. Non corporate U.S. holders may qualify for the preferential rates of taxation applicable to long term capital gains (i.e., gains from the sale of capital assets held for more than one year) with respect to dividends on ADSs if we are a “qualified foreign corporation.” A non-United States corporation (other than a corporation that is classified as a PFIC for the taxable year in which the dividend is paid or the preceding taxable year) generally will be considered to be a qualified foreign corporation (a) if it is eligible for the benefits of a comprehensive tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of these rules and which includes an exchange of information provision (which includes the Treaty), or (b) with respect to any dividend it pays on ADSs which are readily tradable on an established securities market in the United States.
Therefore, subject to the discussion under “Passive Foreign Investment Company Rules,” above, if the Treaty is applicable, or if the ADSs are readily tradable on an established securities market in the United States, such dividends will generally be “qualified dividend income” in the hands of non-corporate U.S. holders eligible for the preferential tax rates, provided that certain conditions are met, including conditions relating to holding period and the absence of certain risk reduction transactions. The amount of the dividend will be treated as foreign-source dividend income to U.S. Holders and will not be eligible for the dividends-received deduction generally available to U.S. corporations under the Code. Dividends will generally be included in a U.S. Holder’s income on the date of the U.S. Holder’s receipt of the dividend. The amount of any dividend income paid in foreign currency will be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date of actual or constructive receipt, regardless of whether the payment is in fact converted into U.S. dollars. If the dividend is converted into U.S. dollars on the date of receipt, a U.S. Holder should not be required to recognize foreign currency gain or loss in respect of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the date of receipt. Such gain or loss would generally be treated as U.S.-source ordinary income or loss. The amount of any distribution of property other than cash (and other than certain pro rata distributions of ordinary shares or ADSs or rights to acquire ordinary shares or ADSs) will be the fair market value of such property on the date of distribution. For foreign tax credit purposes, our dividends will generally be treated as passive category income. The rules relating to the determination of the U.S. foreign tax credit are complex, and U.S. Holders should consult their tax advisors regarding the availability of a foreign tax credit in their particular circumstances and the possibility of claiming a deduction (in lieu of the foreign tax credit) for any foreign taxes paid or withheld.
Sale or Other Taxable Disposition of Ordinary Shares and ADSs
Subject to the discussion above under “Passive Foreign Investment Company Rules,” gain or loss realized on the sale or other taxable disposition of ordinary shares or ADSs will be capital gain or loss, and will be long-term capital gain or loss if the U.S. Holder held the ordinary shares or ADSs for more than one year. The amount of the gain or loss will equal the difference between the U.S. Holder’s tax basis in the ordinary shares or ADSs disposed of and the amount realized on the disposition, in each case as determined in U.S. dollars. This gain or loss will generally be U.S.-source gain or loss for foreign tax credit purposes. The deductibility of capital losses is subject to limitations. If the consideration received by a U.S. Holder is not paid in U.S. dollars, the amount realized will be the U.S. dollar value of the payment received determined by reference to the spot rate of exchange on the date of the sale or other disposition. However, if the ordinary shares or ADSs are treated as traded on an “established securities market” and you are either a cash basis taxpayer or an accrual basis taxpayer that has made a special election (which must be applied consistently from year to year and cannot be changed without the consent of the IRS), you will determine the U.S. dollar value of the amount realized in a non-U.S. dollar currency by translating the amount received at the spot rate of exchange on the settlement date of the sale. If you are an accrual basis taxpayer that is not eligible to or does not elect to determine the amount realized using the spot rate on the settlement date, you will recognize foreign currency gain or loss to the extent of any difference between the U.S. dollar amount realized on the date of sale or disposition and the U.S. dollar value of the currency received at the spot rate on the settlement date. U.S. Holders should consult their tax advisors regarding the tax consequences if foreign taxes are imposed on a taxable disposition of ordinary shares or ADSs and their ability to credit such foreign tax against their U.S. federal income tax liability.
WE STRONGLY URGE YOU TO CONSULT YOUR TAX ADVISOR REGARDING THE IMPACT OF OUR PFIC STATUS ON YOUR INVESTMENT IN THE ORDINARY SHARES OR ADSs AS WELL AS THE APPLICATION OF THE PFIC RULES TO YOUR INVESTMENT IN THE ORDINARY SHARES OR ADSs.
Information Reporting and Backup Withholding
Payments of dividends and sales proceeds that are made within the United States or through certain U.S.-related financial intermediaries generally are subject to information reporting, and may be subject to backup withholding, unless (a) the U.S. Holder is a corporation or other exempt recipient or (b) in the case of backup withholding, the U.S. Holder provides a correct taxpayer identification number and a duly executed IRS Form W-9 or certification of other exempt status that it is not subject to backup withholding, unless the U.S. Holder otherwise establishes that it is exempt from such rules.
Backup withholding is not an additional tax. The amount of any backup withholding from a payment to a U.S. Holder will be allowed as a credit against the holder’s U.S. federal income tax liability and may entitle it to a refund, provided that the required information is timely furnished to the IRS.
Information with Respect to Foreign Financial Assets
Individuals who own “specified foreign financial assets” with an aggregate value in excess of $50,000 may be required to file an information report on IRS Form 8938, “Statement of Specified Foreign Financial Assets,” with respect to such assets with their tax returns. “Specified foreign financial assets” include any financial accounts maintained by foreign financial institutions, as well as any of the following, but only if they are not held in accounts maintained by financial institutions: (i) stocks and securities issued by non-U.S. persons; (ii) financial instruments and contracts held for investment that have non-U.S. issuers or counterparties; and (iii) interests in foreign entities. Such U.S. Holders who fail to timely furnish the required information may be subject to a penalty. Additionally, if a U.S. Holder does not file the required information, the statute of limitations with respect to tax returns of the U.S. Holder to which the information relates may not close until three years after such information is filed. U.S. Holders should consult their tax advisers regarding their reporting obligations with respect to their ownership and disposition of the ordinary shares or ADSs.
Material Dutch Tax Considerations
General
The following is a general summary of certain material Dutch tax consequences of the acquisition, ownership and disposition of our ordinary shares or ADSs. This summary does not purport to describe all possible tax considerations or consequences that may be relevant to a holder or prospective holder of our ordinary shares or ADSs and does not purport to deal with the tax consequences applicable to all categories of investors, some of which (such as trusts or similar arrangements) may be subject to special rules. In view of its general nature, this general summary should be treated with corresponding caution.
This summary is based on the tax laws of The Netherlands, published regulations thereunder and published authoritative case law, all as in effect on the date hereof, and all of which are subject to change, possibly with retroactive effect. Where the summary refers to “The Netherlands” or “Dutch” it refers only to the part of the Kingdom of The Netherlands located in Europe.
This discussion is for general information purposes only and is not Dutch tax advice or a complete description of all Dutch tax consequences relating to the acquisition, ownership and disposition of our ordinary shares or ADSs. Holders or prospective holders of our ordinary shares or ADSs should consult their own tax advisors regarding the Dutch tax consequences relating to the acquisition, ownership and disposition of our ordinary shares or ADSs in light of their particular circumstances.
Please note that this summary does not describe the Dutch tax consequences for:
i.holders of ordinary shares or ADSs if such holders, and in the case of individuals, such holder’s partner or certain of its relatives by blood or marriage in the direct line (including foster children), have a substantial interest (aanmerkelijk belang) or deemed substantial interest (fictief aanmerkelijk belang) in us under the Dutch Income Tax Act 2001 (Wet inkomstenbelasting 2001). Generally speaking, a holder of securities in a company is considered to hold a substantial interest in such company, if such holder alone or, in the case of individuals, together with such holder’s partner (as defined in the Dutch Income Tax Act 2001), directly or indirectly, holds (a) an interest of 5% or more of the total issued and outstanding capital of that company or of 5% or more of the issued and outstanding capital of a certain class of shares of that company; or (b) rights to acquire, directly or indirectly, such interest; or (c) certain profit sharing rights in that company that relate to 5% or more of the company’s annual profits or to 5% or more of the company’s liquidation proceeds. A deemed substantial interest may arise if a substantial interest (or part thereof) in a company has been disposed of, or is deemed to have been disposed of, on a non-recognition basis;
ii.holders of ordinary shares or ADSs, if the ordinary shares or ADSs held by such holders qualify or qualified as a participation (deelneming) for purposes of the Dutch Corporate Income Tax Act 1969 (Wet op de vennootschapsbelasting 1969). Generally, a holder’s shareholding of 5% or more in a company’s nominal paid-up share capital qualifies as a participation. A holder may also have a participation if such holder does not have a shareholding of 5% or more but a related entity (statutorily defined term) has a participation or if the company in which the shares are held is a related entity (statutorily defined term);
iii.pension funds, investment institutions (fiscale beleggingsinstellingen), exempt investment institutions (vrijgestelde beleggingsinstellingen) (each as defined in the Dutch Corporate Income Tax Act 1969) and other entities that are, in whole or in part, not subject to or exempt from Dutch corporate income tax as well as entities that are exempt from corporate income tax in their country of residence, such country of residence being another state of the EU, Norway, Liechtenstein, Iceland or any other state with which The Netherlands has agreed to exchange information in line with international standards; and
iv.holders of ordinary shares or ADSs who are individuals for whom the ordinary shares or ADSs or any benefit derived from the ordinary shares or ADSs are a remuneration or deemed to be a remuneration for activities performed by such holders or certain individuals related to such holders (as defined in the Dutch Income Tax Act 2001).
Withholding tax
Dividends distributed by us generally are subject to Dutch dividend withholding tax at a rate of 15%. Generally, we are responsible for the withholding of such dividend withholding tax at source; the Dutch dividend withholding tax is for the account of the holder of ordinary shares or ADSs.
The expression “dividends distributed” includes, among other things:
•distributions in cash or in kind, deemed and constructive distributions and repayments of paid-in capital not recognized for Dutch dividend withholding tax purposes;
•liquidation proceeds, proceeds of redemption of ordinary shares or ADSs, or proceeds of the repurchase of ordinary shares or ADSs by us or one of our subsidiaries or other affiliated entities to the extent such proceeds exceed the average paid-in capital of those ordinary shares or ADSs as recognized for Dutch dividend withholding tax purposes;
•an amount equal to the par value of ordinary shares or ADSs issued or an increase of the par value of ordinary shares or ADSs, to the extent that it does not appear that a contribution recognized for Dutch dividend withholding tax purposes has been made or will be made; and
•partial repayment of the paid-in capital, recognized Dutch dividend withholding tax purposes, if and to the extent that we have net profits (zuivere winst), unless (a) the general meeting has resolved in advance to make such repayment and (b) the par value of the ordinary shares or ADSs concerned has been reduced by an equal amount by way of an amendment of the company’s Articles of Association.
Individuals and corporate legal entities who are resident or deemed to be resident of The Netherlands for Dutch tax purposes (“Dutch Resident Individuals” and “Dutch Resident Entities”, as the case may be), generally are entitled to an exemption of or a credit for any Dutch dividend withholding tax against their income tax or corporate income tax liability and to a refund of any residual Dutch dividend withholding tax. The same generally applies to holders of ordinary shares or ADSs that are neither resident nor deemed to be resident of The Netherlands if the ordinary shares or ADSs are attributable to a Dutch permanent establishment of such non-resident holder.
A holder of ordinary shares or ADSs resident of a country other than The Netherlands may, depending on such holder’s specific circumstances, be entitled to exemptions from, reductions of, or full or partial refunds of, Dutch dividend withholding tax under Dutch national tax legislation or a double taxation convention in effect between The Netherlands and such other country.
Remittance to the Dutch tax authorities
In general, we will be required to remit all amounts withheld as Dutch dividend withholding tax to the Dutch tax authorities. However, under certain circumstances, we are allowed to reduce the amount to be remitted to the Dutch tax authorities by the lesser of:
•3% of the portion of the distribution paid by us that is subject to Dutch dividend withholding tax; and
•3% of the dividends and profit distributions, before deduction of foreign withholding taxes, received by us from qualifying foreign subsidiaries in the current calendar year (up to the date of the distribution by the Company) and the two preceding calendar years, as far as such dividends and profit distributions have not yet been taken into account for purposes of establishing the above mentioned reduction.
Although this reduction reduces the amount of Dutch dividend withholding tax that we are required to remit to the Dutch tax authorities, it does not reduce the amount of tax that we are required to withhold on dividends distributed by us.
Dividend stripping
Pursuant to legislation to counteract “dividend stripping”, a reduction, exemption, credit or refund of Dutch dividend withholding tax is denied if the recipient of the dividend is not the beneficial owner as described in the Dutch Dividend Withholding Tax Act 1965 (Wet op de dividendbelasting 1965). This legislation generally targets situations in which a shareholder retains its economic interest in shares but reduces the withholding tax costs on dividends by a transaction with another party. It is not required for these rules to apply that the recipient of the dividends is aware that a dividend stripping transaction took place. The Dutch State Secretary of Finance takes the position that the definition of beneficial ownership introduced by this legislation will also be applied in the context of a double taxation convention.
Taxes on income and capital gains
Dutch Resident Entities
Generally speaking, if the holder of ordinary shares or ADSs is a Dutch Resident Entity, any payment under the ordinary shares or ADSs or any gain or loss realized on the disposal or deemed disposal of the ordinary shares or ADSs is subject to Dutch corporate income tax at a rate of 19% with respect to taxable profits up to €200,000 and 25.8% with respect to taxable profits in excess of that amount (rates and brackets for 2023).
Dutch Resident Individuals
If the holder of ordinary shares or ADSs is a Dutch Resident Individual, any payment on the ordinary shares or ADSs or any gain or loss realized on the disposal or deemed disposal of the ordinary shares or ADSs is taxable at the progressive Dutch income tax rates (with a maximum of 49.50% in 2023), if:
i.the ordinary shares or ADSs are attributable to an enterprise from which the holder of ordinary shares or ADSs derives a share of the profit, whether as an entrepreneur (ondernemer) or as a person who has a co-entitlement to the net worth (medegerechtigd tot het vermogen) of such enterprise without being a shareholder (as defined in the Dutch Income Tax Act 2001); or
ii.the holder of ordinary shares or ADSs is considered to perform activities with respect to the ordinary shares or ADSs that go beyond ordinary asset management (normaal, actief vermogensbeheer) or derives benefits from the ordinary shares or ADSs that are taxable as benefits from other activities (resultaat uit overige werkzaamheden).
If the above-mentioned conditions (i) and (ii) do not apply to the individual holder of ordinary shares or ADSs, such holder will be taxed annually on a deemed return (with a maximum of 6.17% in 2023) on the individual’s net investment assets (rendementsgrondslag) for the year, insofar the individual’s net investment assets for the year exceed a statutory threshold (heffingvrij vermogen). The deemed return on the individual’s net investment assets for the year is taxed at a rate of 32%. Actual income, gains or losses in respect of the ordinary shares or ADSs are as such not subject to Dutch income tax.
The net investment assets for the year are the fair market value of the investment assets less the allowable liabilities on January 1st of the relevant calendar year. The ordinary shares or ADSs are included as investment assets. For the net investment assets on January 1, 2023, the deemed return is 6.17%. The deemed return will be adjusted annually on the basis of historic market yields.
Non-residents of The Netherlands
A holder of ordinary shares or ADSs that is neither a Dutch Resident Entity nor a Dutch Resident Individual will not be subject to Dutch taxes on income or capital gains in respect of any payment under the ordinary shares or ADSs or in respect of any gain or loss realized on the disposal or deemed disposal of the ordinary shares or ADSs, provided that:
i.such holder does not have an interest in an enterprise or deemed enterprise (as defined in the Dutch Income Tax Act 2001 and the Dutch Corporate Income Tax Act 1969) which, in whole or in part, is either effectively managed in The Netherlands or carried on through a permanent establishment, a deemed permanent establishment or a permanent representative in The Netherlands and to which enterprise or part of an enterprise the ordinary shares or ADSs are attributable; and
ii.in the event the holder is an individual, such holder does not carry out any activities in The Netherlands with respect to the ordinary shares or ADSs that go beyond ordinary asset management and does not derive benefits from the ordinary shares or ADSs that are taxable as benefits from other activities in The Netherlands.
Gift and inheritance taxes
Residents of The Netherlands
Gift or inheritance taxes will arise in The Netherlands with respect to a transfer of ordinary shares or ADSs by way of a gift by, or on the death of, a holder of such ordinary shares or ADSs who is resident or deemed resident of The Netherlands at the time of the gift or the holder’s death.
Non-residents of The Netherlands
No gift or inheritance taxes will arise in The Netherlands with respect to a transfer of the ordinary shares or ADSs by way of gift by, or on the death of, a holder of ordinary shares or ADSs who is neither resident nor deemed to be resident of The Netherlands, unless:
i.in the case of a gift of ordinary shares or ADSs by an individual who at the date of the gift was neither resident nor deemed to be resident of The Netherlands, such individual dies within 180 days after the date of the gift, while being resident or deemed to be resident of The Netherlands; or
ii.the transfer is otherwise construed as a gift or inheritance made by, or on behalf of, a person who, at the time of the gift or death, is or is deemed to be resident of The Netherlands.
For purposes of Dutch gift and inheritance taxes, amongst others, a person that holds the Dutch nationality will be deemed to be resident of The Netherlands if such person has been resident in The Netherlands at any time during the ten years preceding the date of the gift or such person’s death. Additionally, for purposes of Dutch gift tax, amongst others, a person not holding the Dutch nationality will be deemed to be resident of The Netherlands if such person has been resident in The Netherlands at any time during the twelve months preceding the date of the gift. Applicable tax treaties may override deemed residency.
Value added tax (VAT)
No Dutch VAT will be payable by a holder of ordinary shares or ADSs in respect of any payment in consideration for the ownership or disposition of the ordinary shares or ADSs.
Other taxes and duties
No Dutch registration tax, stamp duty or any other similar documentary tax or duty will be payable by a holder of ordinary shares or ADSs in respect of any payment in consideration for the ownership or disposition of the ordinary shares or ADSs.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
We are subject to the informational requirements of the Exchange Act. Accordingly, we are required to file reports and other information with the SEC, including Annual Reports on Form 20-F and reports on Form 6-K. The SEC maintains an Internet website that contains reports and other information about issuers, like us, that file electronically with the SEC. The address of that website is http://www.sec.gov.
We also make available on our website, free of charge, our Annual Report and the text of our reports on Form 6-K, including any amendments to these reports, as well as certain other SEC filings, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. Our website address is www.pharming.com. The information contained on our website is not incorporated by reference in this Annual Report and our website address is included in this Annual Report as an inactive textual reference only.
I.Subsidiary Information
Not applicable.
J. Annual Report on Security Holder
Not applicable.
Item 11. Quantitative and Qualitative Disclosures About Market Risk
Quantitative and Qualitative Disclosures about Market Risk
Our operations expose us to some financial risks arising from our use of financial instruments, the most significant ones being liquidity, market risk and credit risk. The Board of Directors is responsible for our risk management policies and while retaining responsibility for them it has delegated the authority for designing and operating processes that ensure the effective implementation of the objectives and policies to our finance function. Refer to Note 24 of the Annual Financial Statements.
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.
D. American Depositary Shares
The depositary may charge each person to whom ADSs are issued, including, without limitation, issuances against deposits of shares, issuances in respect of share distributions, rights and other distributions, issuances pursuant to a stock dividend or stock split declared by us or issuances pursuant to a merger, exchange of securities or any other transaction or event affecting the ADSs or deposited securities, and each person surrendering ADSs for withdrawal of deposited securities or whose ADRs are cancelled or reduced for any other reason, $5.00 for each 100 ADSs (or any portion thereof) issued, delivered, reduced, canceled or surrendered, or upon which a share distribution or elective distribution is made or offered, as the case may be. The depositary may sell (by public or private sale) sufficient securities and property received in respect of a share distribution, rights and/or other distribution prior to such deposit to pay such charge.
The following additional charges will also be incurred by the ADR holders, the beneficial owners, by any party depositing or withdrawing shares or by any party surrendering ADSs and/or to whom ADSs are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by us or an exchange of stock regarding the ADSs or the deposited securities or a distribution of ADSs), whichever is applicable:
•a fee of $0.05 or less per ADS held for any cash distribution made, or for any elective cash/stock dividend offered, pursuant to the deposit agreement;
•an aggregate fee of $0.05 or less per ADS per calendar year (or portion thereof) for services performed by the depositary in administering the ADRs (which fee may be charged on a periodic basis during each calendar year and will be assessed against holders of ADRs as of the record date or record dates set by the depositary during each calendar year);
•a fee for the reimbursement of such fees, charges and expenses as are incurred by the depositary and/or any of its agents (including, without limitation, the custodian and expenses incurred on behalf of ADR holders in connection with compliance with foreign exchange control regulations or any law or regulation relating to foreign investment) in connection with the servicing of the shares or other deposited securities, the sale of securities (including, without limitation, deposited securities), the delivery of deposited securities or otherwise in connection with the depositary’s or its custodian’s compliance with applicable law, rule or regulation (which fees and charges will be assessed on a proportionate basis against ADR holders as of the record date or dates set by the depositary and will be payable at the sole discretion of the depositary by billing such ADR holders or by deducting such charge from one or more cash dividends or other cash distributions);
•a fee for the distribution of securities (or the sale of securities in connection with a distribution), such fee being in an amount equal to the $0.05 per ADS issuance fee for the execution and delivery of ADSs which would have been charged as a result of the deposit of such securities (treating all such securities as if they were shares) but which securities or the net cash proceeds from the sale thereof are instead distributed by the depositary to those ADR holders entitled thereto;
•stock transfer or other taxes and other governmental charges;
•cable, telex and facsimile transmission and delivery charges incurred at holders’ request in connection with the deposit or delivery of shares, ADRs or deposited securities;
•transfer or registration fees for the registration of transfer of deposited securities on any applicable register in connection with the deposit or withdrawal of deposited securities; and
•fees of any division, branch or affiliate of the depositary utilized by the depositary to direct, manage and/or execute any public and/or private sale of securities under the deposit agreement. To facilitate the administration of various depositary receipt transactions, including disbursement of dividends or other cash distributions and other corporate actions, the depositary may engage the foreign exchange desk within JPMorgan Chase Bank, N.A., or the Bank, and/or its affiliates in order to enter into spot foreign exchange transactions to convert foreign currency into U.S. dollars. For certain currencies, foreign exchange transactions are entered into with the Bank or an affiliate, as the case may be, acting in a principal capacity. For other currencies, foreign exchange transactions are routed directly to and managed by an unaffiliated local custodian (or other third party local liquidity provider), and neither the Bank nor any of its affiliates is a party to such foreign exchange transactions.
The foreign exchange rate applied to an foreign exchange transaction will be either (a) a published benchmark rate, or (b) a rate determined by a third party local liquidity provider, in each case plus or minus a spread, as applicable. The depositary will disclose which foreign exchange rate and spread, if any, apply to such currency on the “Disclosure” page (or successor page) of www.adr.com. Such applicable foreign exchange rate and spread may (and neither the depositary, the Bank nor any of their affiliates is under any obligation to ensure that such rate does not) differ from rates and spreads at which comparable transactions are entered into with other customers or the range of foreign exchange rates and spreads at which the Bank or any of its affiliates enters into foreign exchange transactions in the relevant currency pair on the date of the foreign exchange transaction. Additionally, the timing of execution of an foreign exchange transaction varies according to local market dynamics, which may include regulatory requirements, market hours and liquidity in the foreign exchange market or other factors. Furthermore, the Bank and its affiliates may manage the associated risks of their position in the market in a manner they deem appropriate without regard to the impact of such activities on the depositary, us, holders or beneficial owners. The spread applied does not reflect any gains or losses that may be earned or incurred by the Bank and its affiliates as a result of risk management or other hedging related activity.
The depositary reimburses the Company for certain expenses incurred by the Company that are related to the maintenance of the ADR program upon such terms and conditions as the Company and the depositary agree from time to time. The depositary may make available to the Company a set amount or a portion of the depositary fees charged in respect of the ADR program or otherwise upon such terms and conditions as the Company and the depositary may agree from time to time.
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
As required by Rule 13a-15 under the Exchange Act, management, including our chief executive officer (“CEO”) and our chief financial officer (“CFO”), has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report. Disclosure controls and procedures refer to controls and other procedures designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
Disclosure controls and procedures include, without limitations, controls and procedures designed to ensure that information required to be disclosed by us in our reports that we file or submit under the Exchange Act is accumulated and communicated to management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding our required disclosures.
Based on such evaluation, due to the material weaknesses in our internal control over financial reporting described below, our CEO and our CFO have concluded that our disclosure controls and procedures were not effective as of December 31, 2023.
B. Management’s Annual Report on Internal Control over Financial Reporting
Management, including the CEO and CFO, is responsible for establishing and maintaining adequate internal control over Pharming’s financial reporting and the preparation of the consolidated financial statements. They conducted an evaluation of the effectiveness of Pharming’s internal control over financial reporting and the preparation of the consolidated financial statements based on the Internal Control - Integrated Framework (2013) issued by COSO.
Internal Control over Financial Reporting
In connection with the preparation of our consolidated financial statements for the year ended December 31, 2023, we have identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
As previously identified and disclosed in the prior year, we continue to have material weaknesses across each of the five components of the COSO framework at the entity level and accordingly, across our business and IT processes. The material weaknesses identified are the following:
•Control Environment - We did not maintain an effective control environment with the structure necessary for effective internal controls over financial reporting. We did not exercise sufficient oversight in order to design and operate effective internal controls.
•Risk Assessment – Our risk and internal control framework is in development and accordingly, we did not identify, implement and operate the controls necessary to respond to the risks of material misstatement.
•Control Activities – The designed and implemented control activities were not sufficient to address all the identified risks of material misstatements. In addition, where control activities are dependent on Information Used in a Control, the Company did not perform controls to determine the completeness and accuracy of such information.
•Information and Communication – Our controls over our IT systems were not effective in ensuring that the information used in financial reporting was timely, accurate, complete, protected and verifiable and we did not have sufficient processes and controls in place to enable appropriate disclosure of such information in our financial reporting processes.
•Monitoring – As the risk assessment and internal control framework are in development, we did not have sufficient controls in place to monitor control activities and identify control deficiencies.
Remediation plan
We are in the process of remediating the material weaknesses identified including further developing and implementing formal policies, processes, internal controls and documentation relating to our financial reporting. We are also in the process of further developing a risk assessment framework which outlines our key processes and controls for all risk of material misstatements.
During 2023, management established a control implementation plan and has been actively working on implementing key controls. Management has taken steps in laying the foundation for the internal control environment by means of the implementation of an Enterprise Resource Planning (ERP) system, establishing an Enterprise Risk Management program, and improving governance.
Management have taken further steps in strengthening the Finance and Internal Control teams through hiring employees in those departments and the involvement of an external party in testing the design, implementation, and where applicable, operating effectiveness of internal controls. Despite the improvements that have been made and several controls that have been implemented during the year, they were not yet sufficient to fully address all the principles in the COSO components.
In 2024, we will continue with the implementation of internal controls and undergo multiple rounds of operational effectiveness testing with support of a third party and to work on remediating any issues resulting from this testing, with the goal of remediating our material weaknesses in the near future. We are also focusing on process improvements and further utilization of our Enterprise Resource Planning system to make processes more efficient and globalized. We believe that this structured and phased approach is essential in order to establishing effective internal controls over financial reporting in a sustainable manner, which will also enable us to support and adapt to the Company’s continuous growth path.
As we implement these remediation efforts and continue to evaluate and work to improve our internal control over financial reporting, our management may determine that additional steps or measures may be necessary to address and remediate the material weaknesses. Management may also determine that it is necessary to modify the above mentioned remediation efforts depending on the circumstances and Company needs. We cannot assure you that these remediation efforts will be successful or that its internal control over financial reporting will be effective in accomplishing all control objectives all of the time. Management will continue to assess the effectiveness of these remediation efforts in connection with its evaluations of internal control over financial report.
C. Attestation Report of the Registered Public Accounting Firm
This Annual Report includes an attestation report of the Company’s registered public accounting firm on the effectiveness of the Company’s internal control over financial reporting.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of Pharming Group N.V.
Opinion on Internal Control over Financial Reporting
We have audited the internal control over financial reporting of Pharming Group N.V. and subsidiaries (the "Company") as at December 31, 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, because of the effect of the material weaknesses identified below on the achievement of the objectives of the control criteria, the Company has not maintained effective internal control over financial reporting as at December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as at and for the year ended December 31, 2023, of the Company and our report dated April 3, 2024, expressed an unqualified opinion on those financial statements.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
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 (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) 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 authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized 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.
Material Weaknesses
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.
The following material weaknesses have been identified and included in management's assessment:
•Control Environment - The Company did not maintain an effective control environment with the structure necessary for effective internal controls over financial reporting. The Company did not exercise sufficient oversight in order to design and operate effective internal controls.
•Risk Assessment – The Company’s risk and internal control framework is in development and accordingly, the Company did not identify, implement and operate the controls necessary to respond to the risks of material misstatement.
•Control activities – The designed and implemented control activities were not sufficient to address all the identified risks of material misstatements. In addition, where control activities are dependent on Information Used in a Control, the Company did not perform controls to determine the completeness and accuracy of such information.
•Information & Communication – The Company’s controls over the IT systems were not effective in ensuring that the information used in financial reporting was timely, accurate, complete, protected and verifiable and the Company did not have sufficient processes and controls in place to enable appropriate disclosure of such information in the financial reporting processes.
•Monitoring – As the risk assessment and internal control framework are in development, the Company did not have sufficient controls in place to monitor control activities and identify control deficiencies.
These material weaknesses were considered in determining the nature, timing, and extent of audit tests applied in our audit of the consolidated financial statements as of and for the year ended December 31, 2023, of the Company, and this report does not affect our report on such financial statements.
/s/ Deloitte Accountants B.V.
Amsterdam, The Netherlands
April 3, 2024
D. Changes in Control over Financial Reporting
Other than as discussed above in Item 15.A, there has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the period covered by this Annual Report that has materially affected, or is reasonably likely to materially affect, internal control over financial reporting.
Item 16. Reserved
Item 16 A. Audit Committee Financial Expert
Our board of directors has determined that Mr. Leonard Kruimer, the Chairman of the Audit Committee, is an “audit committee financial expert” as defined by SEC rules and has the requisite financial sophistication under the applicable rules and regulations of the Nasdaq. Mr. Kruimer is independent, as such term is defined in Rule 10A-3 under the Exchange Act and under the listing standards of Nasdaq.
Item 16 B. Code of Ethics
We have adopted a Code of Conduct, which outlines the principles of legal and ethical business conduct under which we do business. The Code of Conduct applies to all of our Executive Committee members, Board of Directors members and our affiliates and employees. The full text of the Code of Conduct is available on our website at https://www.pharming.com. The information and other content appearing on our website are not part of this Annual Report and our website address is included in this Annual Report as an inactive textual reference only.
We intend to disclose any amendment to the Code of Conduct, or any waivers of its requirements, in our Annual Reports on Form 20-F. For the year ended December 31, 2023, we did not grant any waivers of the Code of Conduct.
Item 16 C. Principal Accountant Fees and Services
Deloitte Accountants B.V., or Deloitte, has served as our independent registered public accounting firm for 2023 and 2022. Our accountants billed the following fees to us for professional services in each of those fiscal years:
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| Amounts in $ ‘000 |
2023 |
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2022 |
| Audit Fees |
(1,328) |
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(1,357) |
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| Audit Related Fees |
— |
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— |
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| Tax Fees |
— |
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— |
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| All Other Fees |
— |
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— |
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| Total |
(1,328) |
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(1,357) |
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“Audit Fees” consist of fees billed for the annual audit of our consolidated financial statements. Audit Fees also include services that only our independent external auditor can reasonably provide, such as the review of documents filed with the SEC. For the fiscal year ended December 31, 2023, and 2022, the aggregate fees billed for audit services by Deloitte were $1.3 million and $1.4 million, respectively.
“Audit-Related Fees” consist of fees billed for assurance and related services that are reasonably related to the performance of the audit or review of its financial statements or that are traditionally performed by the external auditor, and mainly include services such as comfort letters issued in connection with securities offerings, due diligence and agreed-upon or expanded audit procedures. For the fiscal years ended December 31, 2023 and 2022, there were no fees billed for assurance and related services by Deloitte.
“Tax Fees” consist of tax consultations, such as advice in connection with employees’ taxation arising from share-based compensation. For the fiscal years ended December 31, 2023 and 2022, there were no fees billed for tax compliance and tax planning by Deloitte.
“All Other Fees” consist of advisory services such as the adoption or application of IFRS. For the fiscal years ended December 31, 2023 and 2022, there were no fees billed by Deloitte. for other non-audit professional services.
Pre-Approval Policies and Procedures
The Audit Committee evaluates the qualifications, independence and performance of the independent auditor as well as pre-approves and reviews the audit and non-audit services to be performed by the independent auditor.
The Audit Committee reviewed and discussed the external auditor’s 2023 audit plan (including proposed fees) - both in April and December - and the draft management letters submitted by the external auditor. The Audit Committee approved the 2023 audit plan at the meeting held on August 2, 2023. The 2023 Audit Plan and the draft management letters were also shared and discussed with the full Board of Directors.
In accordance with the Audit Committee Charter, as published on the Company’s website www.pharming.com/aboutus/corporategovernance, the Audit Committee monitors compliance with the Dutch and U.S. rules on non-audit services provided by an independent registered public accounting firm.
Accordingly, the Audit Committee shall pre-approve all audit services to be provided to the Company, and all other services (review, attest and non-audit) to be provided to the Company by the external auditor, to the extent permitted under applicable law, provided, however, that de minimis non-audit services may instead be approved in accordance with applicable SEC rules. The Audit Committee did not have to approve non-audit services by Deloitte in 2023.
In March 2023, the Audit Committee evaluated the performance of Deloitte and its duties as external auditor for the financial year 2022. Deloitte was appointed by the general meeting of shareholders held on May 17, 2023, as external auditor for the financial years 2023 and 2024. The Audit Committee discussed during its meeting on March 12, 2024, the outcome of the evaluation and the performance of Deloitte and its duties as external auditor for the financial year 2023. The evaluation resulted in an overall positive outcome.
During its meeting on April 2, 2024, the Audit Committee discussed and confirmed the independence of the external auditor.
Item 16 D. Exemptions from the Listing Standards for Audit Committees
Not applicable.
Item 16 E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
During the year ended December 31, 2023, no purchases of our equity securities were made by or on behalf of us or any affiliated purchaser.
Item 16 F. Change in Registrant’s Certifying Accountant
Not applicable.
Item 16 G. Corporate Governance
Foreign Private Issuer Exemption
We are a “foreign private issuer,” as defined by the SEC. As a result, in accordance with Nasdaq rules, we comply with home country governance requirements and certain exemptions thereunder rather than complying with Nasdaq corporate governance standards. While we voluntarily follow most Nasdaq corporate governance rules, we have chosen, or may decide to choose, to take advantage of the following limited exemptions:
•Exemption from filing quarterly reports on Form 10-Q containing unaudited financial and other specified information or current reports on Form 8-K upon the occurrence of specified significant events;
•Exemption from Section 16 under the Exchange Act, which requires insiders to file public reports of their securities ownership and trading activities and provides for liability for insiders who profit from trades in a short period of time;
•Exemption from the Nasdaq rules applicable to domestic issuers requiring disclosure within four business days of any determination to grant a waiver of the code of conduct and ethics to directors and officers;
•Exemption from the requirement to obtain shareholder approval for certain issuances of securities, including shareholder approval of share option plans;
•Exemption from the requirement that our Audit Committee have review and oversight responsibilities over all “related party transactions,” as defined in Item 7.B of Form 20-F;
•Exemption from the requirement that our board of directors has a compensation committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities; and
•Exemption from the requirements that director nominees are selected, or recommended for selection by our board of directors, either by (a) independent directors constituting a majority of our board of director’s independent directors in a vote in which only independent directors participate, or (b) a committee comprised solely of independent directors, and that a formal written charter or board resolution, as applicable, addressing the nominations process is adopted.
Furthermore, Nasdaq Rule 5615(a)(3) provides that a foreign private issuer, such as us, may rely on home country corporate governance practices in lieu of certain of the rules in the Nasdaq Rule 5600 Series and Rule 5250(d), provided that we nevertheless comply with Nasdaq’s Notification of Noncompliance requirement (Rule 5625), the Voting Rights requirement (Rule 5640) and that we have an Audit Committee that satisfies Rule 5605(c) (3), consisting of committee members that meet the independence requirements of Rule 5605(c)(2)(A)(ii).
We comply with the Nasdaq corporate governance rules applicable to foreign private issuers, which means that we are permitted to follow certain corporate governance rules that conform to Dutch requirements in lieu of many of the Nasdaq corporate governance rules. Accordingly, our shareholders do not have the same protections afforded to shareholders of companies that are subject to all of the corporate governance requirements of Nasdaq. We may utilize these exemptions for as long as we continue to qualify as a foreign private issuer.
For an overview of some specific differences between corporate governance principles for a Netherlands public company, such as us, and those that are applicable to a Delaware corporation, see “Description of Securities” included as Exhibit 2.1 to this Annual Report. This also summarizes our implementation of the corporate governance principles in accordance with Dutch law and the DCGC. Finally, reference is made to the sections “Organizational Structure” and “Directors and Senior Management” for more details on our group structure and corporate governance structure. All referenced sections are incorporated in this section by reference.
Nasdaq Diversity Disclosure
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Board Diversity Matrix (As of March 31, 2024) |
| Country of Principal Executive Offices: |
The Netherlands |
| Foreign Private Issuer: |
Yes |
| Disclosure Prohibited under Home Country Law: |
No |
| Total Number of Directors: |
8 |
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| Part I: Gender Identity |
Female |
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Male |
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Non-Binary |
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Did Not Disclose Gender |
| Directors |
3 |
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5 |
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— |
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— |
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| Part II: Demographic Background |
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| Underrepresented Individual in Home Country Jurisdiction |
0 |
| LGBTQ+ |
0 |
| Did Not Disclose Demographic Background |
0 |
Item 16 H. Mine Safety Disclosure
Not applicable.
Item 16 I. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
Not applicable.
Item 16 J. Insider trading policies
Not applicable.
Item 16 K. Cybersecurity
Risk Management and Strategy
We have established physical, electronic and organizational measures to safeguard and secure our systems and facilities to prevent an information compromise, and rely on commercially available systems, software, tools and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. We have also outsourced elements of our information technology infrastructure, and as a result, a number of third-party vendors may or could have access to our confidential information. Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage or unauthorized access or use resulting from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, denial-of-service attacks, cyber-attacks or cyber-intrusions over the Internet, hacking, phishing and other social engineering attacks, attachments to emails, persons inside our organization (including employees or contractors), lost or stolen devices, or persons with access to systems inside our organization.
We have been, and may in the future be, subject to cyberattacks. However, we have not identified any cybersecurity threats or incidents that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition.
Despite our efforts, we cannot eliminate all risks from cybersecurity threats or incidents, or provide assurances that we have not experienced an undetected cybersecurity incident. For more information about these risks, please see “Risk Factors – We depend on our information technology systems and have been and may in the future be the victim of cyberattacks which compromise the privacy, security, integrity or confidentiality of sensitive information related to our business or prevent us from accessing critical information and expose us to liability and reputational harm, which could adversely affect our business, results of operations and financial condition."
Governance
Our Board of Directors holds oversight responsibility over the Company’s strategy and risk management, including material risks related to cybersecurity threats. This oversight is executed directly by the Board of Directors and through its committees. The Audit Committee oversees the management of systemic risks, including cybersecurity, in accordance with its charter. The Audit Committee engages in regular discussions with management regarding the Company’s significant financial risk exposures and the measures implemented to monitor and control these risks, including those that may result from material cybersecurity threats.
Our CFO oversees our cybersecurity risk management program and has primary responsibility for identifying, assessing and managing our exposure to cybersecurity threats and incidents. Our IT Director reports to our CFO with respect to the prevention, detection, mitigation and remediation of cybersecurity risks.
Item 17. Financial Statements
See ''Item 18 — Financial Statements'' of this Annual Report.
Item 18. Financial Statements
See pages F‑1 through F‑59 of this Annual Report.
Item 19. Exhibits
EXHIBIT INDEX
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Exhibit Number |
Description of Exhibit |
1.1 |
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1.2 |
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2.1 |
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2.2 |
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2.3 |
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| 2.4 |
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4.1 |
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4.2 |
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4.3 |
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4.4 |
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4.5 |
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4.6 |
Asset Purchase Agreement, dated as of August 9, 2016, by and among Salix Pharmaceuticals, Inc., Santarus, Inc., Valeant Pharmaceuticals Luxembourg S.a r.l., Valeant Pharmaceuticals North America LLC, the Registrant and Pharming Americas B.V. (incorporated by reference to Exhibit 10.5 of the Company’s Registration Statement on Form F-1 (File No. 333-250984) filed with the SEC on December 17, 2020).#† |
4.7 |
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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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13.2 |
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| 15.1 |
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| 97.1 |
|
| 101.INS |
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
| 101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
| 101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| 101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
| 101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
| 101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| 104 |
Cover Page Interactive Data File (Formatted as Inline XBRL and contained in Exhibit 101) |
† Portions of this exhibit have been excluded because they are both not material and are the type that the registrant treats as private or confidential.
+ Certain schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC.
# Previously filed.
* Indicates management contract or compensatory plan
SIGNATURES
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.
Pharming Group N.V.
/s/ Sijmen de Vries, MD MBA
——————————————
By: Sijmen de Vries, MD MBA
Title: Chief Executive Officer
Date: April 4, 2024
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| Index to Financial Statements |
| FINANCIAL SECTION |
| Audited consolidated financial statements as of and for the years ended December 31, 2023, 2022, and 2021 |
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| REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM |
To the shareholders and the Board of Directors of Pharming Group N.V.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Pharming Group N.V. and subsidiaries (the "Company") as at December 31, 2023 and 2022 the related consolidated statements of income, comprehensive income, changes in equity and cash flows, for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as at December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated April 3, 2024 expressed an adverse opinion on the Company's internal control over financial reporting because of material weaknesses.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company 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 audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Trade and other payables - U.S. Revenue Rebate Accruals. - Refer to Notes 2.4, 2.5, 4 and 19 to the Financial statements
Critical Audit Matter Description
As of 31 December, 2023, the Company recognized U.S. revenue rebate accruals. The sales in the United States are subject to rebates relating directly to customers or to ultimate reimbursement claims from government or insurance payers, mainly consisting of U.S. Medicaid (“U.S. revenue rebate accruals”). These are accounted for on an estimated basis.
The U.S. revenue rebate accrual involves the use of significant assumptions and judgments in its calculation. These significant assumptions and judgments include historical claims experience, unbilled claims, and claims submission time lags. Given the complexity of this estimate, together with the limited amount of historical data available and judgments necessary to develop this estimate, and the internal control over financial reporting deficiencies identified, auditing this estimate required both extensive audit effort and a high degree of auditor judgment when performing auditing procedures and evaluating the results of those procedures, and therefore we identified the U.S. revenue rebate accruals as a critical audit matter.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to the assumptions and judgments made by management in estimating the U.S. revenue rebate accruals included the following, amongst others:
•We evaluated the appropriateness and consistency of the Company’s method, data, and assumptions used to calculate the U.S. revenue rebate accruals.
•We tested the mathematical accuracy of the U.S. revenue rebate accruals calculation.
•We tested significant assumptions and key inputs used to calculate the U.S. revenue rebate accruals, namely, testing rebate claims received during the financial year against source documentation and assessing the reasonableness of the Board of Directors’ forecast by comparing to historical claims.
•We evaluated the Company’s ability to estimate U.S. revenue rebate accruals accurately by comparing actual claims received during the current year to historical estimates.
•Through the use of data visualizations, we compared recorded U.S. revenue rebate accruals against historic data to evaluate the reasonableness of the estimate.
/s/ Deloitte Accountants B.V.
Amsterdam, The Netherlands
April 3, 2024
We have served as the Company’s auditor since 2019.
CONSOLIDATED STATEMENT OF INCOME
For the year ended December 31,
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| Amounts in $ ‘000 |
|
Notes |
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2023 |
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2022 |
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2021 |
| Revenues |
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4 |
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245,316 |
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205,622 |
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198,871 |
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| Costs of sales |
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6 |
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(25,212) |
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(17,562) |
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(21,142) |
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| Gross profit |
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220,104 |
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188,060 |
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177,729 |
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| Other income |
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5 |
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23,349 |
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14,523 |
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2,620 |
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| Research and development |
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(68,914) |
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(52,531) |
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(70,369) |
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| General and administrative |
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(55,877) |
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(46,016) |
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(36,974) |
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| Marketing and sales |
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(124,049) |
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(85,803) |
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(59,445) |
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| Other Operating Costs |
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6 |
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(248,840) |
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(184,350) |
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(166,788) |
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| Operating profit / (loss) |
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(5,387) |
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18,233 |
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13,561 |
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| Fair value gain (loss) on revaluation |
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(930) |
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(1,185) |
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114 |
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| Other finance income |
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7 |
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3,663 |
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4,485 |
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14,894 |
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| Other finance expenses |
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7 |
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(9,069) |
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(5,463) |
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(6,185) |
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| Finance result, net |
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(6,336) |
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(2,163) |
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8,823 |
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| Share of net profits (loss) in associates using the equity method |
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12 |
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(289) |
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(1,083) |
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694 |
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| (Loss) / Profit before tax |
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(12,012) |
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14,987 |
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23,078 |
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| Income tax expense |
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8 |
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1,464 |
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(1,313) |
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(7,082) |
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| (Loss) / Profit for the year |
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(10,548) |
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13,674 |
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15,996 |
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| Basic (loss) / earnings per share ($) |
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25 |
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(0.016) |
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0.021 |
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0.025 |
| Diluted (loss) / earnings per share ($) |
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25 |
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(0.016) |
|
0.019 |
|
0.023 |
The Notes are an integral part of these financial statements.
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
For the year ended December 31,
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| Amounts in $ ‘000 |
|
Notes |
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2023 |
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2022 |
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2021 |
| Profit for the year |
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(10,548) |
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13,674 |
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15,996 |
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| Currency translation differences |
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26 |
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5,936 |
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(10,349) |
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(14,802) |
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| Items that may be subsequently reclassified to profit or loss |
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5,936 |
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(10,349) |
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(14,802) |
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| Fair value remeasurement investments |
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26 |
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1,167 |
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(705) |
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(2,283) |
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| Items that shall not be subsequently reclassified to profit or loss |
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1,167 |
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(705) |
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(2,283) |
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| Other comprehensive income (loss), net of tax |
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7,103 |
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(11,054) |
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(17,085) |
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| Total comprehensive income (loss) for the year |
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(3,445) |
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2,620 |
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(1,089) |
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The Notes are an integral part of these financial statements.
CONSOLIDATED BALANCE SHEET
As at December 31,
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| Amounts in $ ‘000 |
|
Notes |
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2023 |
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2022 |
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| Non-current assets |
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| Intangible assets |
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9 |
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71,267 |
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75,121 |
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| Property, plant and equipment |
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10 |
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9,689 |
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10,392 |
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| Right-of-use assets |
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11 |
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23,777 |
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28,753 |
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| Long-term prepayments |
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92 |
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228 |
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| Deferred tax assets |
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8 |
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29,761 |
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22,973 |
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| Investment accounted for using the equity method |
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12 |
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2,285 |
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2,501 |
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| Investment in equity instruments designated as at FVTOCI |
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12 |
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2,020 |
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403 |
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| Investment in debt instruments designated as at FVTPL |
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12 |
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6,093 |
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6,827 |
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| Restricted cash |
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14 |
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1,528 |
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1,099 |
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| Total non-current assets |
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146,512 |
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148,297 |
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| Current assets |
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| Inventories |
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15 |
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56,760 |
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42,326 |
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| Trade and other receivables |
|
16 |
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46,158 |
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27,619 |
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| Restricted cash |
|
14 |
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— |
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213 |
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| Marketable securities |
|
13 |
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151,683 |
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— |
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| Cash and cash equivalents |
|
14 |
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61,741 |
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|
207,342 |
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| Total current assets |
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316,342 |
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|
277,500 |
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| Total assets |
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462,854 |
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|
425,797 |
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| Equity |
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| Share capital |
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7,669 |
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7,509 |
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| Share premium |
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|
478,431 |
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462,297 |
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| Other reserves |
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|
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(2,057) |
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|
(8,737) |
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| Accumulated deficit |
|
|
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(265,262) |
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|
(256,431) |
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| Shareholders’ equity |
|
26 |
|
218,781 |
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|
204,638 |
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|
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| Non-current liabilities |
|
|
|
|
|
|
|
|
| Convertible bonds |
|
17 |
|
136,598 |
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|
131,618 |
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|
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| Lease liabilities |
|
18 |
|
29,507 |
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|
29,843 |
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|
|
| Total non-current liabilities |
|
|
|
166,105 |
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|
161,461 |
|
|
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| Current liabilities |
|
|
|
|
|
|
|
|
| Convertible bonds |
|
17 |
|
1,824 |
|
|
1,768 |
|
|
|
| Trade and other payables |
|
19 |
|
72,528 |
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|
54,465 |
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|
|
| Lease liabilities |
|
18 |
|
3,616 |
|
|
3,465 |
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|
|
| Total current liabilities |
|
|
|
77,968 |
|
|
59,698 |
|
|
|
| Total equity and liabilities |
|
|
|
462,854 |
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|
425,797 |
|
|
|
The Notes are an integral part of these financial statements.
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
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| Amounts in US$ ‘000 |
Notes |
Share capital |
|
Share premium |
|
Other reserves |
|
Accumulated deficit |
|
Total equity |
| Balance at January 1, 2021 |
|
7,312 |
|
|
447,130 |
|
|
24,614 |
|
|
(295,621) |
|
|
183,435 |
|
| Profit for the year |
|
— |
|
|
— |
|
|
— |
|
|
15,996 |
|
|
15,996 |
|
| Other comprehensive income (loss) for the year |
26 |
— |
|
|
— |
|
|
(17,085) |
|
|
— |
|
|
(17,085) |
|
| Total comprehensive income (loss) for the year |
|
— |
|
|
— |
|
|
(17,085) |
|
|
15,996 |
|
|
(1,089) |
|
| Legal reserves |
26 |
— |
|
|
— |
|
|
(4,129) |
|
|
4,129 |
|
|
— |
|
| Income tax benefit from excess tax deductions related to share-based payments |
|
— |
|
|
— |
|
|
— |
|
|
(1,853) |
|
|
(1,853) |
|
| Share-based compensation |
20, 26 |
— |
|
|
— |
|
|
— |
|
|
9,056 |
|
|
9,056 |
|
| Warrants exercised/ issued |
26 |
1 |
|
|
80 |
|
|
— |
|
|
— |
|
|
81 |
|
| Options exercised / LTIP shares issued |
26 |
116 |
|
|
8,044 |
|
|
— |
|
|
(4,874) |
|
|
3,286 |
|
| Balance at Total transactions with owners, recognized directly in equity |
|
117 |
|
|
8,124 |
|
|
(4,129) |
|
|
6,458 |
|
|
10,570 |
|
| Balance at January 1, 2022 |
|
7,429 |
|
|
455,254 |
|
|
3,400 |
|
|
(273,167) |
|
|
192,916 |
|
| Profit (loss) for the year |
|
— |
|
|
— |
|
|
— |
|
|
13,674 |
|
|
13,674 |
|
| Other comprehensive income (loss) for the year |
26 |
— |
|
|
— |
|
|
(11,054) |
|
|
— |
|
|
(11,054) |
|
| Total comprehensive income (loss) for the year |
|
— |
|
|
— |
|
|
(11,054) |
|
|
13,674 |
|
|
2,620 |
|
| Other reserves |
26 |
— |
|
|
— |
|
|
(1,083) |
|
|
1,083 |
|
|
— |
|
| Income tax benefit from excess tax deductions related to share-based payments |
|
— |
|
|
— |
|
|
— |
|
|
430 |
|
|
430 |
|
| Share-based compensation |
20, 26 |
— |
|
|
— |
|
|
— |
|
|
6,392 |
|
|
6,392 |
|
| Options exercised / LTIP shares issued |
26 |
80 |
|
|
7,043 |
|
|
— |
|
|
(4,843) |
|
|
2,280 |
|
| Balance at Total transactions with owners, recognized directly in equity |
|
80 |
|
|
7,043 |
|
|
(1,083) |
|
|
3,062 |
|
|
9,102 |
|
| Balance at December 31, 2022 |
|
7,509 |
|
|
462,297 |
|
|
(8,737) |
|
|
(256,431) |
|
|
204,638 |
|
| Profit (loss) for the year |
|
— |
|
|
— |
|
|
— |
|
|
(10,548) |
|
|
(10,548) |
|
| Other comprehensive income (loss) for the year |
26 |
— |
|
|
— |
|
|
7,103 |
|
|
— |
|
|
7,103 |
|
| Total comprehensive income (loss) for the year |
|
— |
|
|
— |
|
|
7,103 |
|
|
(10,548) |
|
|
(3,445) |
|
| Other reserves |
26 |
— |
|
|
— |
|
|
(423) |
|
|
423 |
|
|
— |
|
| Income tax benefit from excess tax deductions related to share-based payments |
|
— |
|
|
— |
|
|
— |
|
|
204 |
|
|
204 |
|
| Share-based compensation |
20, 26 |
— |
|
|
— |
|
|
— |
|
|
9,251 |
|
|
9,251 |
|
| Options exercised / LTIP shares issued |
26 |
160 |
|
|
16,134 |
|
|
— |
|
|
(8,161) |
|
|
8,133 |
|
| Balance at Total transactions with owners, recognized directly in equity |
|
160 |
|
|
16,134 |
|
|
(423) |
|
|
1,717 |
|
|
17,588 |
|
| Balance at December 31, 2023 |
|
7,669 |
|
|
478,431 |
|
|
(2,057) |
|
|
(265,262) |
|
|
218,781 |
|
The Notes are an integral part of these financial statements.
CONSOLIDATED STATEMENT OF CASH FLOWS
As at December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
Notes |
|
2023 |
|
2022 |
|
2021 |
| Profit (loss) before tax |
|
|
(12,012) |
|
|
14,987 |
|
|
23,078 |
|
| Adjustments to reconcile net profit (loss) to net cash used in operating activities: |
|
|
|
|
|
|
|
| Depreciation, amortization, impairment of non-current assets |
6,9,10,11 |
|
15,925 |
|
|
13,188 |
|
|
19,610 |
|
| Equity settled share based payments |
20 |
|
9,251 |
|
|
6,392 |
|
|
9,056 |
|
| Gain on disposal of investment in associate |
5 |
|
— |
|
|
(12,242) |
|
|
— |
|
| Fair value gain (loss) on revaluation |
12 |
|
930 |
|
|
1,185 |
|
|
(114) |
|
| Gain on disposal from PRV sale |
5 |
|
(21,279) |
|
|
— |
|
|
— |
|
| Other finance income |
7 |
|
(3,663) |
|
|
(4,485) |
|
|
(14,906) |
|
| Other finance expenses |
7 |
|
9,069 |
|
|
5,463 |
|
|
6,196 |
|
| Share of net profits in associates using the equity method |
12 |
|
289 |
|
|
1,083 |
|
|
(694) |
|
| Other |
|
|
(1,079) |
|
|
(1,576) |
|
|
524 |
|
| Operating cash flows before changes in working capital |
|
|
(2,569) |
|
|
23,995 |
|
|
42,750 |
|
|
|
|
|
|
|
|
|
| Changes in working capital: |
|
|
|
|
|
|
|
| Inventories |
15 |
|
(14,434) |
|
|
(15,016) |
|
|
(6,153) |
|
| Trade and other receivables |
16 |
|
(18,539) |
|
|
2,364 |
|
|
5,918 |
|
| Payables and other current liabilities |
19 |
|
16,228 |
|
|
11,992 |
|
|
(5,193) |
|
| Restricted cash |
14 |
|
(216) |
|
|
273 |
|
|
467 |
|
| Total changes in working capital |
|
|
(16,961) |
|
|
(387) |
|
|
(4,961) |
|
|
|
|
|
|
|
|
|
| Interest received |
7 |
|
2,883 |
|
|
85 |
|
|
53 |
|
| Income taxes received (paid) |
8 |
|
(655) |
|
|
(1,235) |
|
|
— |
|
|
|
|
|
|
|
|
|
| Net cash flows generated from (used in) operating activities |
|
|
(17,302) |
|
|
22,458 |
|
|
37,842 |
|
| Capital expenditure for property, plant and equipment |
10 |
|
(1,437) |
|
|
(1,376) |
|
|
(10,739) |
|
| Proceeds on PRV sale |
5 |
|
21,279 |
|
|
— |
|
|
— |
|
| Investment intangible assets |
9 |
|
(27) |
|
|
(601) |
|
|
(3,447) |
|
| Proceed from sale of Investment associate |
12 |
|
— |
|
|
7,300 |
|
|
— |
|
| Investment in equity instruments designated as at FVTOCI |
12 |
|
— |
|
|
— |
|
|
(4,589) |
|
| Acquisition of license |
9 |
|
— |
|
|
— |
|
|
(2,530) |
|
| Purchases of marketable securities |
13 |
|
(382,014) |
|
|
— |
|
|
— |
|
| Proceeds from sale of marketable securities |
13 |
|
232,811 |
|
|
— |
|
|
— |
|
| Net cash flows generated from (used in) investing activities |
|
|
(129,388) |
|
|
5,323 |
|
|
(21,305) |
|
| Payment on contingent consideration |
|
|
— |
|
|
— |
|
|
(25,000) |
|
| Payment of lease liabilities |
|
|
(5,126) |
|
|
(3,311) |
|
|
(3,217) |
|
| Interests on loans and leases |
17, 18 |
|
(4,046) |
|
|
(3,952) |
|
|
(4,448) |
|
| Settlement of share based compensation awards |
|
|
8,133 |
|
|
2,281 |
|
|
4,718 |
|
| Net cash flows generated from (used in) financing activities |
|
|
(1,039) |
|
|
(4,982) |
|
|
(27,947) |
|
|
|
|
|
|
|
|
|
| Increase (decrease) of cash |
|
|
(147,729) |
|
|
22,799 |
|
|
(11,410) |
|
| Exchange rate effects |
|
|
2,128 |
|
|
(7,381) |
|
|
(1,825) |
|
|
|
|
|
|
|
|
|
| Cash and cash equivalents at January 1 |
14 |
|
207,342 |
|
|
191,924 |
|
|
205,159 |
|
|
|
|
|
|
|
|
|
| Total cash and cash equivalents at December 31 |
|
|
61,741 |
|
|
207,342 |
|
|
191,924 |
|
The Notes are an integral part of these financial statements.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1.CORPORATE INFORMATION
Pharming Group N.V., hereafter “the Company”, “the Group” or “Pharming”, is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing a portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific.
The consolidated financial statements of Pharming for the year ended December 31, 2023 were authorized for issue in accordance with a resolution of the Board of Directors on April 3, 2024. The financial statements are subject to adoption by the Annual General Meeting of shareholders, which has been scheduled for May 21, 2024.
The headquarters and registered office of Pharming Group N.V. are located at:
Darwinweg 24
2333 CR Leiden
The Netherlands
2.ACCOUNTING PRINCIPLES AND POLICIES
2.1.BASIS OF PREPARATION AND GOING CONCERN ASSUMPTION
The consolidated financial statements are prepared in accordance with the International Financial Reporting Standards, or IFRS, issued by the International Accounting Standards Board, or IASB, and the interpretations issued by the IASB’s International Financial Reporting Interpretation Committee. The consolidated financial statements provide a general overview of our activities and the results achieved and have been prepared on a going concern basis.
Management exercises its judgement in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in Note 2.5 Material accounting judgements and estimates.
These financial statements are presented in U.S. Dollars (US$, USD), and rounded to the nearest thousand U.S. dollars ($‘000), unless otherwise stated.
Going Concern
In preparing the consolidated financial statements, the Board of Directors is responsible for assessing the Group’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 Board of Directors either intends to liquidate the Group or to cease operations, or has no realistic alternative but to do so. These consolidated financial statements have been prepared for the Group as a going concern.
The 2023 year-end balance of cash and cash equivalents, restricted cash and marketable securities of $215.0 million is expected to fund the Company for more than twelve months from the date of this report.
So far, we have not experienced any noteworthy disruption to our supply chain and none of the Company’s (external) production facilities/sales locations have been closed. The receipts from commercial supply of product to our partners in Latin America, South Korea and Israel and proceeds from direct sales in the United States and Europe currently generate more cash than the Company requires for day to day expenses and to supply those sales, and thus the surplus cash generated will support our capital expenditure plans and financial reserves further.
Following the FDA approval of Joenja® (leniolisib) on March 24, 2023, the Company has increased investments in strengthening the organization and marketing and sales activities. The Board of Directors anticipates further investments in the preparations of the launch and commercialization of Joenja® in other key global launch markets in 2024. These investments will have a negative effect on the profit in the year 2024. Consequently, cash and cash equivalents, restricted cash and marketable securities may reduce during the year as the company invests in its future. Revenue from Joenja® is expected to grow from 2024 onwards. The company remains confident in the robustness of RUCONEST® sales, growth and expansion of Joenja® sales and the expansion of its pipeline.
Presently, however, no further assurance can be given on either the timing or size of future profits.
In addition, in the event that the Company needs to raise capital by issuing additional shares, shareholders’ equity interests may be diluted as to voting power, and their interests as to value will depend on the price at which such issues are made. The Company sees no further need to raise capital to support its current operations, but may take an opportunity to do so in either equity issue or through an expansion of the current convertible debt or to raise debt, or through a combination of such instruments, to support an acquisition or in-licensing of additional assets, if appropriate terms can be obtained that are in the best interests of shareholders.
Overall, based on the outcome of this assessment, our 2023 financial statements have been drawn up on the basis of a going concern assumption.
Ukraine / Russian war
Management performed a risk assessment related to the war in Ukraine and determined that the war itself, the effect of the sanctions or the ramifications of the war will not have a material impact on the Pharming business.
2.2New and revised IFRS standards
The Company applied for the first-time certain amendments, which are effective for annual periods beginning on or after January 1, 2023 as disclosed below.
•IFRS 17: Insurance contracts
•Amendments to IAS 1 and IFRS Practice Statement 2: Disclosure of Accounting Policies
•Amendments to IAS 8: Definition of accounting estimates
•Amendments to IAS 12: Deferred tax related to assets and liabilities arising from a single transaction
•Amendments to IAS 12 Income Taxes— International Tax Reform—Pillar Two Model Rules
Their adoption has not had any material impact on the disclosures or on the amounts reported in these financial statements. The Company has not early adopted any other standard, interpretation or amendment that has been issued but are not yet effective. Pillar two model rules are not yet applicable because the Company has not met the revenue threshold.
The new and amended standards and interpretations that are issued, but are not yet effective or endorsed for use in the EU, up to the date of issuance of the Group’s financial statements, which the Group intends to adopt, if applicable, when they become effective, are disclosed below.
•Amendments to IFRS 7 and IAS 7: Supplier Finance Arrangements
•Amendments to IFRS 10 and IAS 28: Sale or contribution of assets between investors and its associate or joint venture
•Amendments to IFRS 16: Lease liability in a Sale and Leaseback
•Amendments to IAS 1: Classification of Liabilities as Current or Non-current
•Amendments to IAS 1: Non-current Liabilities with Covenants
Management does not expect that the adoption of the Standards listed above will have a material impact on the financial statements of the Company in future periods.
2.3Basis of consolidation
The consolidated financial statements include Pharming Group N.V. and its controlled subsidiaries, after the elimination of all intercompany transactions and balances. Subsidiaries are consolidated from the date the acquirer obtains effective control until control ceases.
An entity is considered effectively controlled if the Company, directly or indirectly, has the power to govern the financial and operating policies of an entity so as to obtain benefits from its activities. Acquisitions of subsidiaries are accounted for using the acquisition method of accounting. The financial statements of the subsidiaries are prepared for the same reporting year as Pharming Group N.V., using the same accounting policies. Intercompany transactions, balances and unrealized gains and losses on transactions between group companies are eliminated.
2.4Accounting principles and policies
Foreign currency translation
In preparing the financial statements of the Group, transactions in currencies other than the entity’s functional currency (foreign currencies) are recognized at the rates of exchange prevailing on the dates of the transactions. At each reporting date, monetary assets and liabilities that are denominated in foreign currencies are retranslated at the rates prevailing at that date. Non-monetary items carried at fair value that are denominated in foreign currencies are translated at the rates prevailing at the date when the fair value was determined. Non-monetary items that are measured in terms of historical cost in a foreign currency are not retranslated.
Exchange differences are recognized in profit or loss in the period in which they arise except for:
•Exchange differences on foreign currency borrowings relating to assets under construction for future productive use, which are included in the cost of those assets when they are regarded as an adjustment to interest costs on those foreign currency borrowings;
•Exchange differences on transactions entered into to hedge certain foreign currency risks
•Exchange differences on monetary items receivable from or payable to a foreign operation for which settlement is neither planned nor likely to occur in the foreseeable future (therefore forming part of the net investment in the foreign operation), which are recognized initially in other comprehensive income and reclassified from equity to profit or loss on disposal or partial disposal of the net investment.
For the purpose of presenting consolidated financial statements in U.S. dollars, the assets and liabilities of the Group’s operations having euro as functional currency are translated at exchange rates prevailing on the reporting date. Income and expense items are translated at the average exchange rates for the period, unless exchange rates fluctuate significantly during that period, in which case the exchange rates at the date of transactions are used. Exchange differences arising, if any, are recognized in other comprehensive income and accumulated in a foreign exchange translation reserve.
The EUR/$ exchange rate applied at December 31, 2023, December 31, 2022 and December 31, 2021 was 1.1002, 1.0667 and 1.1334 respectively. The average exchange rate applied in 2023, 2022 and 2021 was 1.0790, 1.0543 and 1.186 respectively.
Distinction between current and non-current
An item is classified as current when it is expected to be realized (settled) within 12 months after the end of the reporting year. Liabilities are classified as current liabilities unless the Group has an unconditional right to defer settlement of the liability for at least 12 months after the end of the reporting year.
Intangible assets acquired separately
Intangible assets, or IFA, acquired separately are measured at historical cost. The cost of intangible assets acquired in a business combination is recognized and measured at fair value as at the date of acquisition. Following initial recognition, intangible assets are carried at cost less any accumulated amortization and any accumulated impairment losses.
Intangible assets with finite lives are amortized over the useful life and assessed for impairment whenever there is an indication that the intangible assets may be impaired and at the end of each reporting period. The estimated useful lives, residual values and amortization method are reviewed at the end of each reporting period, with the effect of any changes in estimate accounted for on a prospective basis. Changes in the expected useful life, according to the straight-line method, or the expected pattern of consumption of future economic benefits embodied in the asset is accounted for by changing the amortization period or method, as appropriate, and treated as changes in accounting estimates. The amortization expense on intangible assets with finite lives is recognized in the statement of income in the relevant expense category consistent with the function of the intangible asset.
The remaining amortization periods for intangible assets at December 31, 2023 are:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization period |
| Category |
Description |
Total |
Remaining |
| RUCONEST® for HAE (EU) |
RUCONEST® for HAE (EU) development costs |
10 years |
Fully amortized |
| RUCONEST® license |
RUCONEST® license for HAE (US) |
20 years |
13 years |
| RUCONEST® license |
RUCONEST® license for HAE (EU) |
12 years |
8 years |
| JOENJA® license |
JOENJA® license for APDS |
14 years |
13 years |
| Software |
Software development costs |
3 to 5 years |
2 to 5 years |
Derecognition of intangible assets
An intangible asset is derecognized on disposal, or when no future economic benefits are expected from use or disposal. Gains or losses arising from derecognition of an intangible asset, measured as the difference between the net disposal proceeds and the carrying amount of the asset, are recognized in profit or loss when the asset is derecognized.
Biological Assets
Under IAS 41 “Agriculture”, management is required to assess whether ‘biological assets’ which are contributing to production of our cash flows should be accounted for as assets. Management has assessed Pharming’s biological assets and conclude that these do not qualify to be recognized under the relevant standard IAS 41 “Agriculture” due to their uniqueness and very special transgenic nature and thus all relevant costs are expensed through the income statement.
Property, plant and equipment
Property, plant and equipment is stated at cost less accumulated depreciation charges and accumulated impairment charges. Generally, depreciation is calculated using a straight-line basis over the estimated useful life of the asset. The estimated useful lives, residual values and depreciation method are reviewed at the end of each reporting period, with the effect of any changes in estimate accounted for on a prospective basis. The carrying values of property, plant and equipment are reviewed for impairment when events or changes in circumstances indicate that the carrying value may not be recoverable.
An item of property, plant and equipment is derecognized upon disposal or when no future economic benefits are expected from its use or disposal.
Any gain or loss arising on derecognition of the asset (calculated as the difference between the net disposal proceeds and the carrying amount of the asset) is included in the statement of income in the year the asset is derecognized. Residual values, useful lives and depreciation methods are reviewed, and adjusted if appropriate, at each financial year-end.
All costs that are directly attributable to bringing an asset to the location and condition necessary for it to be capable of operating in the manner intended by management, will be capitalized. These costs include direct employee benefits, rent and testing costs. Capitalization will be done until the asset is capable of operating in the manner intended by management.
The depreciation periods for property, plant and equipment are:
|
|
|
|
|
|
| Category |
Depreciation period |
| Land |
Not depreciated |
| Operational facilities |
10-20 years |
| Leasehold improvements |
5-15 years |
| Machinery and equipment |
5-10 years |
| Other property, plant & equipment |
5-10 years |
Investments in associates
An associate is an entity over which the Group has significant influence and that is neither a subsidiary nor an interest in a joint venture. Significant influence is the power to participate in the financial and operating policy decisions of the investee but is not control or joint control over those policies. The results and assets and liabilities of associates are incorporated in these financial statements using the equity method of accounting. Under the equity method, an investment in an associate is recognized initially in the consolidated statement of financial position at cost and adjusted thereafter to recognize the Group’s share of the profit or loss and other comprehensive income of the associate.
When the Group’s share of losses of an associate exceeds the Group’s interest in that associate (which includes any long-term interests that, in substance, form part of the Group’s net investment in the associate), the Group discontinues recognizing its share of further losses. Additional losses are recognized only to the extent that the Group has incurred legal or constructive obligations or made payments on behalf of the associate. The requirements of IAS 36 are applied to determine whether it is necessary to recognize any impairment loss with respect to the Group’s investment in an associate.
When necessary, the entire carrying amount of the investment (including goodwill) is tested for impairment in accordance with IAS 36 as a single asset by comparing its recoverable amount (higher of value in use and fair value less costs of disposal) with its carrying amount. Any impairment loss recognized is not allocated to any asset, including goodwill that forms part of the carrying amount of the investment. Any reversal of that impairment loss is recognized in accordance with IAS 36 to the extent that the recoverable amount of the investment subsequently increases.
When a Group entity transacts with an associate of the Group, profits and losses resulting from the transactions with the associate or joint venture are recognized in the Group’s consolidated financial statements only to the extent of interests in the associate or joint venture that are not related to the Group.
Financial assets
Financial assets are recognized when the Company becomes a party to the contractual provisions of a financial instrument. Financial assets are derecognized when the rights to receive cash flows from the financial assets expire, or if the Company transfers the financial asset to another party and does not retain control or substantially all risks and rewards of the asset. Purchases and sales of financial assets in the normal course of business are accounted for at settlement date (i.e., the date that the asset is delivered to or by the Company).
At initial recognition, the Company measures its financial assets at its fair value plus, in the case of a financial asset not at fair value through profit or loss, transaction costs that are directly attributable to the acquisition or issue of the financial asset.
After initial recognition, the Company classifies its financial assets as subsequently measured at either i) amortized cost, ii) fair value through other comprehensive income or iii) fair value through profit or loss on basis of both:
•The Company’s business model for managing the financial assets;
•The contractual cash flow characteristics of the financial asset.
Subsequent to initial recognition, financial assets are measured as described below. At each balance sheet date, the Company assesses whether there is objective evidence that a financial asset or a group of financial assets is impaired and recognizes a loss allowance for expected credit losses for financial assets measured at either amortized costs or at fair value through other comprehensive income. If, at the reporting date, the credit risk on financial instrument has not increased significantly since initial recognition, the Company measures the loss allowance for that financial instrument at an amount equal to 12 months of expected credit losses. If, at the reporting date, the credit risk on a financial instrument has increased significantly since initial recognition, the Company measures the loss allowance for the financial instrument at an amount equal to the lifetime expected credit losses.
Financial assets at amortized cost
Financial assets are measured at amortized cost if both i) the financial asset is held within a business model whose objective is to hold financial assets in order to collect contractual cash flows; and ii) the contractual terms of the financial asset give rise on specified dates to cash flows that are solely payments of principal and interest of on the principal amount outstanding.
A financial asset measured at amortized cost is initially recognized at fair value plus transaction cost directly attributable to the asset. After initial recognition, the carrying amount of the financial asset measured at amortized cost is determined using the effective interest method, less any impairment losses.
Financial assets at fair value through other comprehensive income, or FVTOCI
On initial recognition, the Group may make an irrevocable election (on an instrument-by-instrument basis) to designate investments in equity instruments as at FVTOCI. Investments in equity instruments at FVTOCI are initially measured at fair value plus transaction costs.
Subsequently, they are measured at fair value with gains and losses arising from changes in fair value recognized in other comprehensive income and accumulated in the legal reserve fair value revaluation. The cumulative gain or loss is not reclassified to profit or loss on disposal of the equity investments, instead, it is transferred to retained earnings.
Financial assets at fair value through profit and loss, or FVTPL
Financial assets that do not meet the criteria for being measured at amortized cost or FVTOCI are measured at FVTPL.
Financial assets at FVTPL are measured at fair value at the end of each reporting period, with any fair value gains or losses recognized in profit or loss. The net gain or loss recognized in profit or loss includes any dividend or interest earned on the financial asset and is included in the ‘fair value gain (loss) on revaluation’ line item (Note 12. Investments). Fair value is determined in the manner described in 12. Investments.
Impairment of assets
Assets that have an indefinite useful life and assets not yet available for use are not subject to depreciation or amortization and are tested at least annually for impairment. Assets that are subject to depreciation or amortization are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows. Non-financial assets for which an impairment loss is recorded, are reviewed for possible reversal of the impairment at each reporting date.
Inventories
Inventories are stated at the lower of cost and net realizable value. Cost comprises direct materials and, where applicable, direct labor costs and those overheads that have been incurred in bringing the inventories to their present location and condition. Cost is calculated using the First in First out (FIFO) method. Net realizable value represents the estimated selling price less all estimated costs of completion and costs to be incurred in marketing, selling and distribution.
Trade and other receivables
Trade and other receivables are recognized initially at transaction price. Subsequent measurement is at amortized cost using the effective interest method, less the expected credit loss. Trade receivables are amounts due from customers for goods sold in the ordinary course of business. They are generally due for settlement within 30 days and therefore are all classified as current. For trade receivables and contract assets, the Company applies a simplified approach in calculating expected credit loss. The Company assesses the expected credit loss that is based on its historical credit loss experience, adjusted for forward-looking factors specific to the debtors and the economic environment. Due to the short-term nature of the current receivables, their carrying amount is considered to be the same as their fair value.
Cash and cash equivalents
Cash and cash equivalents are defined as cash on hand, demand deposits and short-term, highly liquid investments (maturity less than 3 months) readily convertible to known amounts of cash and subject to insignificant risk of changes in value. Bank overdrafts are shown within borrowings in current liabilities on the statement of financial position. For the purpose of the statement of cash flow, cash and cash equivalents are net of outstanding bank overdrafts and do not include restricted cash.
Marketable securities
Marketable securities are financial assets held for short-term purposes which are principally traded in liquid markets and are classified within current assets on the consolidated balance sheet. Marketable securities are measured as financial assets as described above. The financial impacts related to Marketable securities are recorded in ‘Other finance income’ in the consolidated statement of income. The cash (re)payments relating to Marketable securities are classified as investing activities. The cash flows relating to interest from Marketable securities held at amortized cost are classified as cash flows generated from operating activities.
Equity
The Company only has ordinary shares, and these are classified within equity upon issue. Shares transferred in relation to settlement of (convertible) debt are measured at fair value with fair value based on the closing price of the shares on the trading day prior to the settlement date. Equity is recognized upon the recognition of share-based payment expenses; shares issued upon exercise of such options are measured at their exercise price.
Transaction costs associated with an equity transaction are accounted for as a deduction from equity to the extent they are incremental costs directly attributable to the equity transaction that otherwise would have been avoided. Transaction costs related to the issue of a compound financial instrument are allocated to the liability and equity components of the instruments in proportion to the allocation of proceeds.
Financial liabilities
Financial liabilities are classified as either financial liabilities at fair value through profit or loss (derivative financial liabilities) or financial liabilities at amortized cost (trade and other payables). All financial liabilities at amortized cost are initially recognized at the fair value of the consideration received less directly attributable transaction costs; transaction costs related to the issue of a compound financial instrument are allocated to the liability and equity components of the instruments in proportion to the allocation of proceeds. After initial recognition, financial liabilities are subsequently measured at amortized cost using the effective interest method.
Gains and losses are recognized in the statement of income when the liabilities are paid off or otherwise eliminated as well as through the amortization process. Purchases and sales of financial liabilities are recognized at settlement date.
A financial liability is derecognized when the obligation under the liability is discharged or cancelled or expired. Where an existing financial liability is replaced by another from the same lender on substantially different terms, or the terms of an existing liability are substantially modified, such an exchange or modification is treated as a derecognition of the original liability and the recognition of a new liability, and the difference in the respective carrying amounts is recognized in the statement of income.
Convertible bonds
The component parts of convertible bonds issued by the Group are classified separately as financial liabilities and equity in accordance with the substance of the contractual arrangements and the definitions of a financial liability and an equity instrument. A conversion option that will be settled by the exchange of a fixed amount of cash or another financial asset for a fixed number of the Company’s own equity instruments is an equity instrument.
At the date of issue, the fair value of the liability component is estimated using the prevailing market interest rate for a similar non-convertible instrument. This amount is recorded as a liability on an amortized cost basis using the effective interest method.
The conversion option classified as equity is determined by deducting the amount of the liability component from the fair value of the compound instrument as a whole. This is recognized and included in equity, net of income tax effects, and is not subsequently remeasured.
The equity component is not remeasured after initial recognition.
Transaction costs that relate to the issue of the convertible bond are allocated to the liability and equity components in proportion to the allocation of the gross proceeds. Transaction costs relating to the equity component are recognized directly in equity. Transaction costs relating to the liability component are included in the carrying amount of the liability component and are amortized over the life of the convertible bond using the effective interest method.
In the case the Company extinguishes the convertible bond before maturity through an early redemption or repurchase the difference between the carrying amount of the financial liability (or part of the financial liability) extinguished or transferred to another party and the consideration paid, including any non-cash assets transferred or liabilities assumed, will be recognized in profit or loss.
Provisions
Provisions are recognized when there is a present obligation (legal or constructive) as a result of a past event, it is probable that the Group will be required to settle that obligation and a reliable estimate can be made of the amount of the obligation. The amount recognized as a provision is the best estimate of the consideration required to settle the present obligation at the reporting date, taking into account the risks and uncertainties surrounding the obligation. Where a provision is measured using the cash flows estimated to settle the present obligation, its carrying amount is the present value of those cash flows (when the effect of the time value of money is material). The expense relating to any provision is presented in the statement of income net of any reimbursement.
Trade and other payables
Trade and other payables are initially recognized at fair value. Subsequent measurement is at amortized cost using the effective interest method.
Revenue recognition
In order to determine when to recognize revenue and at what amount, the Company applies the following five steps, based on transfer of control over goods to the customer:
1.Identify the contract(s) with a customer;
2.Identify the performance obligations in the contract. Performance obligations are promises in a contract to transfer to a customer goods that are distinct;
3.Determine the transaction price. The transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer. If the consideration promised in a contract includes a variable amount, an entity must estimate the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods or services to a customer;
4.Allocate the transaction price to each performance obligation on the basis of the relative stand-alone selling prices of each distinct good or service promised in the contract;
5.Recognize revenue when a performance obligation is satisfied by transferring a promised good or service to a customer (which is when the customer obtains control of that good or service). A performance obligation may be satisfied at a point in time (typically for promises to transfer goods to a customer) or over time (typically for promises to transfer services to a customer). For a performance obligation satisfied over time, an entity would select an appropriate measure of progress to determine how much revenue should be recognized as the performance obligation is satisfied.
All of the Group’s revenue from contracts with customers is derived from delivery of goods, specifically pharmaceutical products. The Group does not provide any additional services (including financing services) or equipment to its customers. In accordance with IFRS 15, revenue is recognized when the customer obtains control of the goods. For the Group’s contracts the customer usually obtains control immediately after shipment of the product, which arrives at the customer within a short time frame.
The vast majority of the Group’s contracts for revenue with customers are subject to chargebacks, discounts and/or rebates relating directly to customers or to ultimate reimbursement claims from government or insurance payers. These are accounted for on an estimated net basis, with any actual discounts and rebates used to refine the estimates in due course. These variable elements are deducted from revenue in the same period as the related sales are recorded. Due to the nature of these variable elements, it is not practicable to give meaningful sensitivity estimates due to the large volume of variables that contribute to the overall discounts, rebates and chargebacks accruals.
Other income
Other income consists of gains upon sale of investments, income from government grants, and gain on the sale of the Rare Pediatric Disease Priority Review Voucher (PRV).
Pharming receives certain grants which support the Company’s research efforts in defined research and development projects. These subsidies generally provide for reimbursement of approved costs incurred as defined in various grants. Subsidies are recognized if the Company can demonstrate it has complied with all attached conditions and it is probable that the grant amount will be received. Grants are recognized in profit or loss on a systematic basis over the periods in which the Group recognizes as expenses the related costs for which the grants are intended to compensate.
The Company includes income from grants under other income in the statement of income in order to enable comparison of its statement of income with companies in the life sciences sector.
Pharming was granted the PRV by the Food and Drug Administration (FDA) in March 2023 in connection with the approval of Joenja®. The sale price was a contractually defined percentage of the PRV value pursuant to the terms of the August 2019 exclusive license agreement between Pharming and Novartis for leniolisib. Management made an assessment on the classification of this transaction, taking into account the requirements in IAS 1 and concluded that it is most appropriate to classify the transaction in Other income.
Costs of sales
Costs of sales represent all production costs related to product sales, including production costs of the skimmed milk, external manufacturing costs, costs of vials used for product testing, royalties and other costs incurred in bringing the inventories to their present location and condition. The costs are measured at their actual costs based on FIFO and incurred to net realizable value if sales price is below actual costs.
Research and development costs
Research expenditure is recognized as an expense in the period in which it is incurred. An intangible asset arising from development expenditure on an individual project is recognized only when the following criteria are met:
•The technical feasibility of completing the intangible asset so that it will be available for use or sale is not in doubt;
•The Company has the clear intention and resources to complete the asset, and to use or sell it;
•Its ability to use or sell the asset is not in doubt;
•The probability of future economic benefits is clear at the time of making the decision;
•The availability of resources to complete the development required is not expected to change during the development process;
•It is possible to measure the expenditure reliably during the development.
Technical feasibility and ability to use or sell the asset are, in general, considered probable when the Company estimates that obtaining marketing approval is deemed likely. In practice this is only the case when we have either (i) completed a similar program before on the same therapeutic molecule or combination, or (ii) completed an identical program before on a similar molecule or combination. In other situations, the likelihood of success at each remaining level of clinical development and regulatory approval is assessed and, unless the collective probability is considered high, the criteria is difficult to meet in these circumstances.
Following the initial recognition of the development expenditure, the cost model is applied requiring the asset to be carried at cost less any accumulated amortization and accumulated impairment losses.
Any expenditure capitalized is amortized over the period of expected useful life of the related patents. The carrying value of development costs is reviewed for impairment annually when the asset is not yet in use or more frequently when an indication of impairment arises during the reporting year.
Interest income
Interest income is recognized as interest accrues, using the effective interest method. For the purpose of the consolidated statement of cash flows, interest income derived from cash and cash equivalents have been presented as operating cash flows.
Operating costs
Operating costs are expensed as incurred. Costs of research and development cover those activities that are carried out to gain new scientific or technical knowledge and understanding as well as the application of research findings or other knowledge to a plan or design for the production of new or substantially improved products. Costs of general and administrative nature apply to overhead expenses. Costs of marketing and sales relate to all expenses incurred to commercialize the product.
Short-term employee benefits
The Company does not provide any benefits based on financial measurement of the statement of income.
Liabilities for wages and salaries, including non-monetary benefits and accumulating sick leave that are expected to be settled wholly within 12 months after the end of the period in which the employees render the related service are recognized in respect of employees’ services up to the end of the reporting period and are measured at the amounts expected to be paid when the liabilities are settled. The liabilities are presented under trade and other payables in the balance sheet.
Pension plan
For all Dutch employees, the Company participates in defined contribution pension plans with an independent insurance company. Defined contributions are expensed in the year in which the related employee services are rendered.
Employees in the United States are enabled to participate in a 401k plan, which also qualifies as a defined contribution plan. To become an eligible participant, an employee must complete 6 months of service and attain the age of 18 years.
The employer matches 100% of the first 3% the employee contributes to their 401k plan and 50% of any amount over 3% up to 5%. Any employee contribution over 5% is not matched. Costs of the 401k plan are expensed in the year in which the related employee services are rendered.
Share-based payment
The costs of option plans are measured by reference to the fair value of the options on the date on which the options are granted. The fair value is determined using the Black-Scholes model. The costs of these options are recognized in the income statement (share-based compensation) during the vesting period, together with a corresponding increase in equity (other reserves). Share-based payment charges do not affect liabilities or cash flows in the year of expense since all transactions are equity-settled.
Pharming’s employee option plan states that an employee is entitled to exercise the vested options within five years after the date of the grant. The period in which the options become unconditional is defined as the vesting period.
Long Term Incentive Plan
For a limited number of board members and officers, performance shares are granted free of charge. A maximum number of predetermined shares vest three years after the grant date, provided that the participant to the long-term incentive plan is still in service (continued employment condition), with actual shares to be transferred based on the relative achievement of Pharming’s share price compared to a peer group. The maximum number of shares immediately vests upon a change of control.
The fair value is determined using Monte Carlo simulation. The costs of the LTIP are recognized in the income statement during the vesting period. The fair value at the grant date includes the market performance condition (relative total shareholder return performance) but excludes the three-year service condition. The performance includes Total Shareholder Return (40% weighing) and achievement of long-term strategy oriented objectives (60% weighing). The Total Shareholders Return is compared to a peer group.
The shares granted to the Executive Director under the LTIP, will vest in 3 years after the grant date, subject to the achievement of targets for a three-year performance period, their relative weightings and the pay-out limits. All shares will be subject to a retention period of 5 years from the date of grant. In order to fully become entitled to the shares vesting under the LTI conditions the participant must be a member of the Board of Directors as Executive Board Member at the vesting date.
The costs of the LTIP are recognized in the income statement during the vesting period.
Restricted Stock Unit Plan
For a limited number of board members and officers, restricted stock units are granted free of charge. A maximum number of predetermined shares vest four years after the grant date, provided that the participant to the long-term incentive plan is still in service (continued employment condition).
The fair value is determined to be the market price at the grant date. The costs of the RSU grant are recognized in the income statement during the vesting period.
Leases
The Group assesses whether a contract is or contains a lease at the inception of the contract. The Group recognizes a right-of-use asset and a corresponding lease liability with respect to all lease arrangements in which it is a lessee, except for short-term leases (defined as leases with a lease term of 12 months or less) and leases of low value assets (such as tablets and personal computers, small items of office furniture and telephones). For these leases the Group recognizes the lease payments as an operating expense on a straight-line basis over the term of the lease unless another systematic basis is more representative of the time pattern in which the economic benefits from the leased assets are consumed.
The lease liability is initially measured at the present value of the lease payments that are not paid at the commencement date, discounted by using the rate implicit in the lease. If this rate cannot be readily determined, the Company uses its incremental borrowing rate.
Lease payments included in the measurement of the lease liability comprise:
•Fixed lease payments;
•Variable lease payments that depend on an index or rate, initially measured using the index or rate at the commencement date.
The lease liability is presented as a separate line in the consolidated balance sheet.
The lease liability is subsequently measured by increasing the carrying amount to reflect the interest on the lease liability (using the effective interest method) and by reducing the carrying amount to reflect the lease payments made.
The Group remeasures the lease liability (and makes a corresponding adjustment to the related right-of-use asset) whenever:
•The lease term has changed or there is a significant event or change in circumstances resulting in a change in the assessment of exercise of a purchase option, in which case the lease liability is remeasured by discounting the revised lease payments using a revised discount rate.
•The lease payments change due to changes in an index or rate or a change in expected payment under a guaranteed residual value, in which case the lease liability is remeasured by discounting the revised lease payments using an unchanged discount rate (unless the lease payments change is due to a change in a floating interest rate, in which case, a revised discount rate is used).
•A lease contract is modified, and the lease modification is not accounted for as a separate lease, in which case the lease liability is remeasured based on the lease term of the modified lease by discounting the revised lease payments using a revised discount rate at the effective date of modification.
The right-of-use assets comprise the initial measurement of the corresponding lease liability, lease payments made at or before commencement day, less any lease incentives received and any initial direct costs. They are subsequently measured at cost less accumulated depreciation and impairment losses.
Whenever the Group incurs an obligation for costs to dismantle and remove a leased asset, restore the site on which it is located or restore the underlying asset to the condition required by the terms and conditions of the lease, a provision is recognized and measured under IAS 37. To the extent that the costs relate to a right-of-use asset, the costs are included in the related right-of-use asset, unless those costs are incurred to produce inventories.
Right-of-use assets are depreciated over the shorter period of lease term and useful life of the underlying asset. If a lease transfers ownership of the underlying asset or the cost of the right-of-use asset reflects that the Group expects to exercise a purchase option, the related right-of-use asset is depreciated over the useful life of the underlying asset. The depreciation starts at the commencement date of the lease.
The right-of-use assets are presented as a separate line in the consolidated balance sheet.
The Group applies IAS 36 to determine whether a right-of-use asset is impaired and accounts for any identified impairment loss as described in the ‘Property, Plant and Equipment’ policy.
Variable rents that do not depend on an index or rate are not included in the measurement of the lease liability and the right-of-use asset. The related payments are recognized as an expense in the period in which the event or condition triggers those payments occur.
As a practical expedient, IFRS 16 permits a lessee not to separate non-lease components, and instead account for any lease and associated non-lease components as a single arrangement. The Group has not used this practical expedient. For contracts that contain lease components and one or more additional lease or non-lease components, the Group allocates the consideration in the contract to each lease component on the basis of the relative stand-alone price of the lease component and the aggregate stand-alone price of the lease component and the aggregate stand-alone price of the non-lease components.
The Group had no such lease arrangements in 2023 and has none at the date of this report.
Income taxes
The income tax expense or credit for the period is the tax payable on the current period’s taxable income based on the applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses.
The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at the end of the reporting period in the countries where the Company and its subsidiaries operate and generate taxable income. Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation. It establishes provisions where appropriate based on amounts expected to be paid to the tax authorities.
Deferred income tax is provided in full, using the liability method on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. Deferred income tax is determined using tax rates that have been enacted or substantially enacted by the end of the reporting period and are expected to apply when the related deferred income tax asset is realized, or the deferred income tax liability is settled.
Deferred tax assets are recognized only if it is probable that future taxable amounts will be available to use those temporary differences and losses. The Company has assessed all its income tax amounts and provisions in the light of IFRIC 23 Accounting for Uncertain Income Taxes, and has concluded that it is probable that its particular tax treatment will be accepted in all relevant jurisdictions and thus it has determined taxable profit (tax loss), tax bases, unused tax losses, unused tax credits or tax rates consistently with the tax treatment included in its income tax filings.
Current and deferred tax is recognized in profit or loss, except to the extent that it relates to items recognized in other comprehensive income or directly in equity.
Cash flow statement
Operating cash flows in the statement of cash flows are reported using the indirect method. Under the indirect method the figure is produced by adjusting the profit and loss by removing the effects of non-cash items and changes in working capital. The Company has chosen the profit before tax as a starting point for the reconciliation as most of the other elements in the net result have a non-cash nature. Payments of the finance lease liabilities related to operating assets and equipment are included in the operating cash flows, whereas all other finance lease liabilities are included in financing cash flows. They are part of the manufacturing costs, thus part of the working capital. This way the statement properly reflects the cash flows.
Earnings per share
Basic earnings per share are calculated based on the weighted average number of ordinary shares outstanding during the period. Diluted earnings per share are computed based on the weighted average number of ordinary shares outstanding including the dilutive effect of shares to be issued in the future under certain arrangements such as option plans, warrants issued and convertible loan agreements.
Segment reporting
Operating segments are reported in a manner consistent with the internal reporting of segmental information provided to and used by the chief operating decision-maker function in managing that segment.
2.5 Material accounting judgements and estimates
The preparation of financial statements requires judgments and estimates that affect the reported amounts of assets and liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities at the date of the financial statements. The resulting accounting estimates will, by definition, seldom equal the related actual results.
The main estimates and assumptions that have a risk of causing an adjustment to the carrying amounts of assets and liabilities within the next financial year are addressed below.
Judgements:
Biological Assets
Under IAS 41 “Agriculture”, management is required to assess whether ‘biological assets’ which are contributing to production of our cash flows should be accounted for as assets. Management has assessed Pharming’s biological assets and conclude that these do not qualify to be recognized under the relevant standard IAS 41 “Agriculture” due to their uniqueness and very special transgenic nature and thus all relevant costs are expensed through the income statement.
Estimates:
Revenue - U.S. Revenue Rebate Accruals
Revenue is recognized when control has been transferred to the customer. Revenue is reduced by chargebacks and rebates for government healthcare programs, discounts to specialty pharmacies and wholesalers, and product returns given or expected to be given, which vary by patient groups. Chargebacks and rebates for healthcare programs depend upon the submission of claims sometime after the initial recognition of the sale. The liability for this variable consideration is made, at the time of sale, for the estimated chargebacks and rebates, mainly U.S. Medicaid, based on available market information and historical experience. Because the amounts are estimated they may not fully reflect the final outcome, and the amounts are subject to change dependent upon, amongst other things, the types of patient groups. The amounts of these liabilities is being reviewed and adjusted regularly in the light of contractual and legal obligations, historical charges and trends, past experience and projected mixtures of patient groups. The Group acquires this information from both internal resources and external parties.
Future events could cause the assumptions on which the accruals are based to change, which could affect the future results of the Group.
3.SEGMENT INFORMATION
Operating segments are components of the Company that engage in business activities from which it may incur expenses, for which discrete financial information is available and whose operating results are evaluated regularly by the Company’s Chief Operating Decision Maker (“CODM”) to make decisions about resources to be allocated to the segment and assess its performance. The Executive Members of the Board of Directors are considered the CODM.
CODM reviews the Company’s results under four operating segments based on a combination of the products that the Company has launched - RUCONEST® and Joenja®, and the main geographies where sales are consummated - focused on the US and reporting, in aggregate, Europe and Rest of the World (“RoW”). The four operating segments correspond to each of its four reportable segments for financial reporting purposes.
Joenja® was launched in 2023 and therefore Joenja® related operating segments and comparative information for 2022 and 2021 is not available.
The CODM reviews revenues and gross profit to assess the performance of their operating segments. The CODM does not review financial information on a segmental basis below gross margin, and balance sheet information is not allocated to the company's reportable segments. There are no intersegment sales.
Total revenues and gross profit per each operating and reportable segment for the period ended for the years ended December 31, 2023, 2022 and 2021 are:
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|
|
|
|
|
|
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|
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|
|
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|
|
| Amounts in US$ ‘000 |
2023 |
|
2022 |
|
2021 |
|
RUCONEST® |
Joenja® |
Total |
|
RUCONEST® |
Joenja® |
Total |
|
RUCONEST® |
Joenja® |
Total |
| Revenues: |
|
|
|
|
|
|
|
|
|
|
|
| US |
221,213 |
|
17,894 |
|
239,107 |
|
|
200,082 |
|
— |
|
200,082 |
|
|
193,419 |
|
— |
|
193,419 |
|
| Europe and RoW |
5,921 |
|
288 |
|
6,209 |
|
|
5,540 |
|
— |
|
5,540 |
|
|
5,452 |
|
— |
|
4,933 |
|
| Total revenues |
227,134 |
|
18,182 |
|
245,316 |
|
|
205,622 |
|
— |
|
205,622 |
|
|
198,871 |
|
— |
|
198,871 |
|
| Gross profit: |
|
|
|
|
|
|
|
|
|
|
— |
|
| US |
202,441 |
|
15,417 |
|
217,858 |
|
|
186,263 |
|
— |
|
186,263 |
|
|
176,266 |
|
— |
|
176,266 |
|
| Europe and RoW |
2,026 |
|
220 |
|
2,246 |
|
|
1,797 |
|
— |
|
1,797 |
|
|
1,463 |
|
— |
|
1,463 |
|
| Total gross profit |
204,467 |
|
15,637 |
|
220,104 |
|
|
188,060 |
|
— |
|
188,060 |
|
|
177,729 |
|
— |
|
177,729 |
|
Substantially all of the Company’s non-current assets are located in The Netherlands.
4.REVENUE
The revenue fully relates to the transfer of goods and is recognized at a point in time when the goods have been delivered to the customer. For the years ended December 31, 2023 and 2022, the sales of RUCONEST® in the U.S. market were $221.2 million and $200.1 million. In 2021, the sales of RUCONEST® in the US market were US$193.4 million The first sales of Joenja® in the U.S. market subsequent to the FDA approval in March 2023 was $17.9 million.
Revenues of RUCONEST® in Europe and Rest of the World amounted to $5.9 million in 2023 compared to $5.5 million in 2022 and $5.5 million in 2021.
Two U.S. customers represented approximately $204.3 million, or 83%, of our net revenues in 2023, per customer $108.4 million and $95.9 million respectively. In 2022 these two U.S. customers represented approximately $173.6 million, or 84%, per customer $89.3 million and $84.3 million respectively. In 2021 these two U.S. customers represented approximately $156.6 million, or 79%, per customer $84.3 million and $72.3 million respectively. These customers are large specialty wholesale companies that are specialized in distribution of pharmaceuticals in our and our competitors’ disease area and that distribute our product.
5.OTHER INCOME
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|
|
|
|
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| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Grants |
1,784 |
|
|
1,774 |
|
|
2,620 |
|
| Gain on divestment in associates |
— |
|
|
12,242 |
|
|
— |
|
| Proceeds from PRV sale |
21,279 |
|
|
— |
|
|
— |
|
| Other |
286 |
|
|
507 |
|
|
— |
|
| Total |
23,349 |
|
|
14,523 |
|
|
2,620 |
|
The received grants amounted to $1.8 million in 2023 (2022: $1.8 million; 2021: $2.6 million). The grants are annual payroll-tax reimbursement granted by the Dutch and French governments for research and development activities actually conducted by the Company in those countries.
In June 2023, Pharming announced that it had entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to Novartis for a one-time payment of $21.3 million. Pharming was granted the PRV by the FDA in March 2023 in connection with the approval of Joenja®. The sale price was a contractually defined percentage of the PRV value pursuant to the terms of the August 2019 exclusive license agreement between Pharming and Novartis for leniolisib.
The amount has changed from the previously disclosed US$21.1 million in the press release as a result of currency movements throughout the year.
In 2022 Pharming reduced its minority stake in BioConnection from 43.85% to 22.98%. As a result of this transaction, Pharming has recognized a gain in 2022 of $12.2 million.
6.EXPENSES BY NATURE
Costs of sales
Costs of sales in 2023, 2022 and 2021 were as follows:
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|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Cost of inventories recognized as expenses |
(21,404) |
|
|
(17,398) |
|
|
(19,107) |
|
| Royalty fees |
(2,145) |
|
|
— |
|
|
— |
|
| Obsolete inventory impairments |
(1,663) |
|
|
(164) |
|
|
(2,035) |
|
| Total |
(25,212) |
|
|
(17,562) |
|
|
(21,142) |
|
Pharming expensed royalty fees to Novartis on Joenja® sales, amounting to $2.1 million in 2023 (2022: $0.0 million, 2021: $0.0 million). See note 23. Commitments and contingencies for further information on the royalty fees to Novartis.
Obsolete inventory impairment stems from the valuation of the inventories against lower net realizable value and mainly relates to products no longer eligable for commercial sales. Impairments related to inventories designated for commercial activities in 2023, 2022 and 2021 amounted to a charge of $1.7 million, $0.2 million and $2.0 million.
Costs of research and development
Research and development costs in 2023, 2022 and 2021 were as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Employee costs |
(26,830) |
|
|
(20,595) |
|
|
(24,451) |
|
| Amortization costs intangible assets |
(218) |
|
|
(55) |
|
|
(132) |
|
| Impairment losses intangible assets |
(253) |
|
|
— |
|
|
(4,992) |
|
| Depreciation Property, plant and equipment and right of use assets |
(1,636) |
|
|
(1,602) |
|
|
(3,152) |
|
| Direct Operating Expenses |
(36,226) |
|
|
(27,107) |
|
|
(33,190) |
|
| Other indirect research and development costs |
(3,751) |
|
|
(3,172) |
|
|
(4,452) |
|
| Total research and development costs |
(68,914) |
|
|
(52,531) |
|
|
(70,369) |
|
Operating expenses for research and development activities in 2023, 2022 and 2021 were $68.9 million, $52.5 million and $70.4 million. The costs for 2023 and 2022 mainly relates to spend in research in, and approval of, leniolisib for the treatment of activated Phosphoinositide 3-kinase Delta syndrome (APDS) and AKI and cattle costs. The costs for 2021 include costs incurred for OTL-105 ($13.1 million) and impairment losses of $5.0 million on intangible assets related to the development of RUCONEST® in a more convenient form for patients.
Costs of general and administrative activities
General and administrative costs for 2023, 2022 and 2021 were as follows:
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|
|
|
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|
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|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Employee costs |
(21,216) |
|
|
(14,868) |
|
|
(12,178) |
|
| Amortization costs intangible assets |
(650) |
|
|
(492) |
|
|
— |
|
| Depreciation PPE and right of use assets |
(3,118) |
|
|
(2,525) |
|
|
(857) |
|
| Impairment losses PPE and right of use assets |
(4,663) |
|
|
(4,376) |
|
|
(5,447) |
|
| Direct Operating Expenses |
(11,240) |
|
|
(9,038) |
|
|
(8,419) |
|
| Other indirect general and administrative costs |
(14,990) |
|
|
(14,717) |
|
|
(10,073) |
|
| Total general and administrative costs |
(55,877) |
|
|
(46,016) |
|
|
(36,974) |
|
Other indirect general and administrative costs include insurance, compliance and other costs.
Costs of marketing and sales activities
Marketing and sales costs for 2023, 2022 and 2021 were as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Employee costs |
(44,478) |
|
|
(32,858) |
|
|
(24,125) |
|
| Amortization costs intangible assets |
(4,985) |
|
|
(3,765) |
|
|
(4,098) |
|
| Depreciation PPE and right of use assets |
(403) |
|
|
(372) |
|
|
(930) |
|
| Direct Operating Expenses |
(67,366) |
|
|
(42,398) |
|
|
(28,543) |
|
| Other indirect marketing and sales costs |
(6,817) |
|
|
(6,410) |
|
|
(1,749) |
|
| Total marketing and sales costs |
(124,049) |
|
|
(85,803) |
|
|
(59,445) |
|
Employee benefit costs for 2023, 2022 and 2021 were as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Salaries |
(71,690) |
|
|
(53,328) |
|
|
(44,202) |
|
| Social security costs |
(8,604) |
|
|
(6,317) |
|
|
(5,318) |
|
| Pension costs |
(2,980) |
|
|
(2,284) |
|
|
(2,179) |
|
| Share-based compensation |
(9,251) |
|
|
(6,392) |
|
|
(9,055) |
|
| Total |
(92,525) |
|
|
(68,321) |
|
|
(60,754) |
|
Salaries include holiday allowances and cash bonuses for staff.
Depreciation and amortization charges
Depreciation and amortization charges are included in:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Property, plant and equipment |
(1,494) |
|
|
(1,993) |
|
|
(2,158) |
|
| Intangible assets |
(5,852) |
|
|
(4,312) |
|
|
(4,232) |
|
| Total |
(7,346) |
|
|
(6,305) |
|
|
(6,390) |
|
|
|
|
|
|
|
| Right of use assets |
(3,664) |
|
|
(2,565) |
|
|
(2,781) |
|
| Total |
(3,664) |
|
|
(2,565) |
|
|
(2,781) |
|
7.OTHER FINANCIAL INCOME AND EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Interest income |
3,663 |
|
|
85 |
|
|
53 |
|
| Foreign currency gains |
— |
|
|
4,400 |
|
|
14,841 |
|
| Other financial income |
3,663 |
|
|
4,485 |
|
|
14,894 |
|
| Foreign currency losses |
(2,971) |
|
|
— |
|
|
— |
|
| Interest loans and borrowings |
(4,876) |
|
|
(4,736) |
|
|
(5,296) |
|
| Interest leases |
(1,088) |
|
|
(622) |
|
|
(795) |
|
| Other financial expenses |
(134) |
|
|
(105) |
|
|
(94) |
|
| Other financial expenses |
(9,069) |
|
|
(5,463) |
|
|
(6,185) |
|
|
|
|
|
|
|
| Total other financial income and expenses |
(5,406) |
|
|
(978) |
|
|
8,709 |
|
Interest income
Interest income reflects interest received on readily convertible S&P AAA-rated government treasury certificates with a maturity of six months or less from the date of acquisition.
Foreign currency results
These results primarily follow from the revaluation of bank balances which are denominated in foreign currencies, mainly U.S. dollars, and the timing of foreign currency payments against the actual exchange rate as compared to the original exchange rate applied upon the charge of fees or expenses. The losses in 2023 are mainly a result of the revaluation of the bank balances in U.S. dollars, incorporated in our Dutch entities where the functional currency is euro.
Interest on convertible bonds
Interest on convertible bonds in 2023, 2022 and 2021 relate to coupons and amortized costs on the convertible bonds as disclosed in note 17. Convertible bonds. The amortized costs are calculated at the effective rate of interest, which takes account of any equity component on recognition such as warrants or early repayment options.
8.INCOME TAX
Income taxes on ordinary activities
The following table specifies the current and deferred tax components of income taxes in the income statement:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Income tax expense |
|
|
|
|
|
| Current tax |
|
|
|
|
|
| Current tax on profit for the year |
(5,343) |
|
|
(3,761) |
|
|
(97) |
|
| Adjustments for current tax of prior periods |
241 |
|
|
(9) |
|
|
96 |
|
| Total current tax expense |
(5,102) |
|
|
(3,770) |
|
|
(1) |
|
|
|
|
|
|
|
| Deferred income tax |
|
|
|
|
|
| Deferred tax on profit for the year |
6,639 |
|
|
2,581 |
|
|
(8,196) |
|
| Adjustments for deferred tax of prior periods |
(73) |
|
|
(124) |
|
|
1,115 |
|
| Total deferred tax expense |
6,566 |
|
|
2,457 |
|
|
(7,081) |
|
| Income tax expense |
1,464 |
|
|
(1,313) |
|
|
(7,082) |
|
Effective income tax rate
Pharming Group’s effective rate in its consolidated income statement differed from The Netherlands’ statutory tax rate of 25.8%. The following table reconciles the tax credit (expense) at the statutory rate to actual credit (expense) for the year in the consolidated income statement:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in US$ ‘000 |
2023 |
|
2022 |
|
2021 |
| Reconciliation of tax charge |
|
|
|
|
|
| Profit, (loss) before taxation |
(12,012) |
|
|
14,987 |
|
|
23,078 |
|
Profit, (loss) multiplied by standard rate of tax in The Netherlands |
3,099 |
|
|
(3,866) |
|
|
(5,770) |
|
|
|
|
|
|
|
| Effects of: |
|
|
|
|
|
| Tax rate in other jurisdictions |
1,123 |
|
|
554 |
|
|
307 |
|
| Non-taxable income |
6 |
|
|
2,680 |
|
|
370 |
|
| Non deductible expenses |
(266) |
|
|
(7) |
|
|
(99) |
|
| Share based payments |
(2,022) |
|
|
(531) |
|
|
(2,475) |
|
| Adjustments of prior periods |
168 |
|
|
15 |
|
|
655 |
|
| Change in statutory applicable tax rate |
— |
|
|
(1) |
|
|
555 |
|
| Other |
(644) |
|
|
(157) |
|
|
(625) |
|
| Income tax credit (expense) for the year |
1,464 |
|
|
(1,313) |
|
|
(7,082) |
|
Factors affecting current and future tax charges
The main difference between the nominal tax and the effective tax for the year 2023 can be explained by the effects of non-taxable income, mainly related to the other income generated from the dilution of shares of our investment accounted for using the equity method and share-based payments, U.S. State taxes and the effect of taxable income generated and taxed in jurisdictions where tax rates differ from the statutory rate in The Netherlands.
Deferred tax
The balance of the net deferred tax assets/(liabilities) is therefore shown below:
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Total deferred tax assets |
37,863 |
|
|
29,211 |
|
| Total deferred tax liabilities |
(8,102) |
|
|
(6,238) |
|
| Total net deferred tax assets /(liabilities) |
29,761 |
|
|
22,973 |
|
The deferred tax assets and liabilities are offset since there is a legally enforceable right to set off current tax assets against current tax liabilities and to the extent the intention exists, to settle on a net basis or realize the asset and settle the liability simultaneously.
The significant components and annual movements of deferred income tax assets as of December 31, 2023 and December 31, 2022 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Intangible assets |
2,183 |
|
|
9,876 |
|
| Lease liabilities |
7,063 |
|
|
7,042 |
|
| Accruals |
4,151 |
|
|
2,026 |
|
| Unrealized profit in inventory |
8,453 |
|
|
3,176 |
|
| Other |
3,484 |
|
|
3,545 |
|
| Tax losses |
12,529 |
|
|
3,546 |
|
| Total deferred tax assets |
37,863 |
|
|
29,211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
Intangible assets |
|
Lease liabilities |
|
Accruals |
|
Unrealized profit in inventory |
|
Other |
|
Tax losses |
|
Total |
| At January 1, 2022 |
10,493 |
|
|
3,795 |
|
|
2,289 |
|
|
— |
|
|
2,672 |
|
|
7,776 |
|
|
27,025 |
|
| (Charged)/credited |
|
|
|
|
|
|
|
|
|
|
|
|
|
| - to profit or loss |
— |
|
|
3,431 |
|
|
(263) |
|
|
3,139 |
|
|
607 |
|
|
(3,814) |
|
|
3,100 |
|
| - other movement |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(28) |
|
|
— |
|
|
(28) |
|
| - to accumulated deficit |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
337 |
|
|
— |
|
|
337 |
|
| - currency translation |
(617) |
|
|
(184) |
|
|
— |
|
|
37 |
|
|
(43) |
|
|
(416) |
|
|
(1,223) |
|
| At December 31, 2022 |
9,876 |
|
|
7,042 |
|
|
2,026 |
|
|
3,176 |
|
|
3,545 |
|
|
3,546 |
|
|
29,211 |
|
| (Charged)/credited |
|
|
|
|
|
|
|
|
|
|
|
|
|
| - to profit or loss |
(7,806) |
|
|
(177) |
|
|
2,103 |
|
|
5,077 |
|
|
566 |
|
|
8,702 |
|
|
8,465 |
|
| - other movement |
— |
|
|
(19) |
|
|
22 |
|
|
— |
|
|
(192) |
|
|
— |
|
|
(189) |
|
| - to accumulated deficit |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(457) |
|
|
— |
|
|
(457) |
|
| - currency translation |
113 |
|
|
217 |
|
|
— |
|
|
200 |
|
|
22 |
|
|
281 |
|
|
833 |
|
| At December 31, 2023 |
2,183 |
|
|
7,063 |
|
|
4,151 |
|
|
8,453 |
|
|
3,484 |
|
|
12,529 |
|
|
37,863 |
|
Based upon the Company’s latest budget for 2024 and its long-range forecasts for the three years thereafter, it is considered probable that there will be sufficient taxable profits in the future to realize the deferred tax assets, and therefore these assets should continue to be recognized in these financial statements.
Accruals represent deferred tax assets recognized for temporary differences between the carrying amount and tax bases of accrued liabilities in the United States.
The unused tax losses were incurred by the Dutch fiscal unity and Pharming Healthcare.
The current part of the net deferred tax assets is $10.5 million and $5.4 million for the years ended December 31, 2023 and 2022.
The component and annual movement of deferred income tax liabilities as of December 31, 2023 and December 31, 2022 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Tangible fixed assets |
(4,865) |
|
|
(6,238) |
|
| Other liabilities |
(3,237) |
|
|
— |
|
| Total deferred tax liabilities |
(8,102) |
|
|
(6,238) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
Tangible fixed assets |
|
Other liabilities |
|
Total |
| At January 1, 2022 |
(4,149) |
|
|
(1,660) |
|
|
(5,809) |
|
| (Charged)/credited |
|
|
|
|
|
| - to profit or loss |
(2,302) |
|
|
1,660 |
|
|
(642) |
|
| - other movement |
28 |
|
|
— |
|
|
28 |
|
| - currency translation |
185 |
|
|
— |
|
|
185 |
|
| At December 31, 2022 |
(6,238) |
|
|
— |
|
|
(6,238) |
|
| (Charged)/credited |
|
|
|
|
|
| - to profit or loss |
1,516 |
|
|
(3,414) |
|
|
(1,898) |
|
| - other movement |
13 |
|
|
178 |
|
|
191 |
|
| - currency translation |
(156) |
|
|
(1) |
|
|
(157) |
|
| At December 31, 2023 |
(4,865) |
|
|
(3,237) |
|
|
(8,102) |
|
9.INTANGIBLE_ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
|
RUCONEST® for HAE (EU) |
|
Development costs |
|
RUCONEST® licenses |
|
Joenja® license |
|
Software |
|
Total |
| At cost |
|
598 |
|
|
7,180 |
|
|
71,811 |
|
|
25,185 |
|
|
4,255 |
|
|
109,029 |
|
| Accumulated: |
|
|
|
|
|
|
|
|
|
|
|
|
| Amortization charges |
|
(598) |
|
|
— |
|
|
(17,441) |
|
|
— |
|
|
(242) |
|
|
(18,281) |
|
| Impairment charges |
|
— |
|
|
(6,914) |
|
|
— |
|
|
— |
|
|
— |
|
|
(6,914) |
|
| Carrying value at January 1, 2022 |
|
— |
|
|
266 |
|
|
54,370 |
|
|
25,185 |
|
|
4,013 |
|
|
83,834 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amortization charges |
|
— |
|
|
— |
|
|
(3,597) |
|
|
— |
|
|
(720) |
|
|
(4,317) |
|
| Assets acquired |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
601 |
|
|
601 |
|
| Divestments - cost |
|
— |
|
|
(6,431) |
|
|
— |
|
|
— |
|
|
— |
|
|
(6,431) |
|
| Divestment - impairment charges |
|
— |
|
|
6,431 |
|
|
— |
|
|
— |
|
|
— |
|
|
6,431 |
|
| Currency translation - cost |
|
(35) |
|
|
(499) |
|
|
(4,228) |
|
|
(1,482) |
|
|
(235) |
|
|
(6,479) |
|
| Currency translation - amortization |
|
35 |
|
|
— |
|
|
984 |
|
|
— |
|
|
(20) |
|
|
999 |
|
| Currency translation - impairment |
|
— |
|
|
483 |
|
|
— |
|
|
— |
|
|
— |
|
|
483 |
|
| MOVEMENT 2022 |
|
— |
|
|
(16) |
|
|
(6,841) |
|
|
(1,482) |
|
|
(374) |
|
|
(8,713) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| At cost |
|
563 |
|
|
250 |
|
|
67,583 |
|
|
23,703 |
|
|
4,621 |
|
|
96,720 |
|
| Accumulated: |
|
|
|
|
|
|
|
|
|
|
|
|
| Amortization charges |
|
(563) |
|
|
— |
|
|
(20,054) |
|
|
— |
|
|
(982) |
|
|
(21,599) |
|
| Impairment charges |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Carrying value at December 31, 2022 |
|
— |
|
|
250 |
|
|
47,529 |
|
|
23,703 |
|
|
3,639 |
|
|
75,121 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amortization charges |
|
— |
|
|
— |
|
|
(3,681) |
|
|
(1,300) |
|
|
(884) |
|
|
(5,865) |
|
| Impairment charges |
|
— |
|
|
(253) |
|
|
— |
|
|
— |
|
|
— |
|
|
(253) |
|
| Assets acquired |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
27 |
|
|
27 |
|
| Divestments - cost |
|
— |
|
|
(253) |
|
|
— |
|
|
— |
|
|
(18) |
|
|
(271) |
|
| Divestment - accumulated amortization |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
12 |
|
|
12 |
|
| Divestment - impairment charges |
|
— |
|
|
253 |
|
|
— |
|
|
— |
|
|
— |
|
|
253 |
|
| Currency translation - cost |
|
18 |
|
|
3 |
|
|
2,126 |
|
|
744 |
|
|
142 |
|
|
3,033 |
|
| Currency translation - amortization |
|
(18) |
|
|
— |
|
|
(702) |
|
|
(26) |
|
|
(44) |
|
|
(790) |
|
| Movement 2023 |
|
— |
|
|
(250) |
|
|
(2,257) |
|
|
(582) |
|
|
(765) |
|
|
(3,854) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| At cost |
|
581 |
|
|
— |
|
|
69,709 |
|
|
24,447 |
|
|
4,772 |
|
|
99,509 |
|
| Accumulated: |
|
|
|
|
|
|
|
|
|
|
|
|
| Amortization charges |
|
(581) |
|
|
— |
|
|
(24,437) |
|
|
(1,326) |
|
|
(1,898) |
|
|
(28,242) |
|
| Carrying value at December 31, 2023 |
|
— |
|
|
— |
|
|
45,272 |
|
|
23,121 |
|
|
2,874 |
|
|
71,267 |
|
RUCONEST® for HAE (EU)
The Company has capitalized development costs in relation to RUCONEST® for HAE in the EU. Following market launch of the product in 2010 the amortization of the asset started, and no further development costs have been capitalized in respect to this item since then. These development costs are fully amortized since the end of 2021.
Development costs
During 2023 the Company decided to discontinue the Pompe disease program and therefore impaired and disposed the remaining assets related to the development costs for alpha-glucosidase for Pompe disease.
RUCONEST® license (referred to as 'Re-acquired rights and Licenses' in 2022)
The RUCONEST® license relates to RUCONEST® acquisition of all North American commercialization rights from Bausch Health (formerly Valeant Pharmaceuticals) in 2016 and the RUCONEST® acquisition of all European commercialization and distribution rights from Swedish Orphan International AB, or Sobi, in 2020.
Joenja® (referred to as 'Novartis license' in 2022)
In August 2019, Pharming entered into a development collaboration and license agreement with Novartis to develop and commercialize leniolisib, the P13Kδ inhibitor being developed by Novartis to treat patients with Activated Phosphoinositide 3-kinase Delta Syndrome, or APDS. In 2023, no additional development costs were capitalized. Following FDA approval March 24, 2023 the amortization of Joenja® license commenced.
Software
Amortization of software is mainly related to our ERP system SAP S/4HANA.
10.PROPERTY, PLANT AND EQUIPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
|
Land and land improvements |
|
Operational facilities |
|
Leasehold Improvement |
|
Machinery and equipment |
|
Other |
|
Asset under construction |
|
Total |
| At cost |
|
31 |
|
|
5,200 |
|
|
5,706 |
|
|
14,840 |
|
|
4,158 |
|
|
623 |
|
|
30,558 |
|
| Accumulated depreciation |
|
— |
|
|
(2,839) |
|
|
(2,035) |
|
|
(10,572) |
|
|
(1,890) |
|
|
— |
|
|
(17,336) |
|
| Carrying value at January 1, 2022 |
|
31 |
|
|
2,361 |
|
|
3,671 |
|
|
4,268 |
|
|
2,268 |
|
|
623 |
|
|
13,222 |
|
| Investments |
|
— |
|
|
54 |
|
|
15 |
|
|
797 |
|
|
504 |
|
|
6 |
|
|
1,376 |
|
| Internal transfer - cost |
|
— |
|
|
— |
|
|
42 |
|
|
380 |
|
|
170 |
|
|
(592) |
|
|
— |
|
| Internal transfer - accumulated depreciation |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Other - cost |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Other - accumulated depreciation |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Divestments |
|
(29) |
|
|
(214) |
|
|
(107) |
|
|
(6,422) |
|
|
(27) |
|
|
— |
|
|
(6,799) |
|
| Impairment |
|
— |
|
|
(72) |
|
|
(55) |
|
|
(377) |
|
|
(13) |
|
|
— |
|
|
(517) |
|
| Depreciation charges |
|
— |
|
|
(403) |
|
|
(294) |
|
|
(1,116) |
|
|
(822) |
|
|
— |
|
|
(2,635) |
|
| Depreciation of disinvestment |
|
— |
|
|
214 |
|
|
107 |
|
|
6,097 |
|
|
27 |
|
|
— |
|
|
6,445 |
|
| Currency translation - cost |
|
(2) |
|
|
(309) |
|
|
(319) |
|
|
(940) |
|
|
(101) |
|
|
(31) |
|
|
(1,702) |
|
| Currency translation - accumulated depreciation |
|
— |
|
|
162 |
|
|
114 |
|
|
676 |
|
|
50 |
|
|
— |
|
|
1,002 |
|
| Movement 2022 |
|
(31) |
|
|
(568) |
|
|
(497) |
|
|
(905) |
|
|
(212) |
|
|
(617) |
|
|
(2,830) |
|
| At cost |
|
— |
|
|
4,659 |
|
|
5,282 |
|
|
8,278 |
|
|
4,691 |
|
|
6 |
|
|
22,916 |
|
| Accumulated depreciation |
|
— |
|
|
(2,866) |
|
|
(2,108) |
|
|
(4,915) |
|
|
(2,635) |
|
|
— |
|
|
(12,524) |
|
| Carrying value at December 31, 2022 |
|
— |
|
|
1,793 |
|
|
3,174 |
|
|
3,363 |
|
|
2,056 |
|
|
6 |
|
|
10,392 |
|
| Investments |
|
— |
|
|
32 |
|
|
60 |
|
|
682 |
|
|
488 |
|
|
175 |
|
|
1,437 |
|
| Internal transfer - cost |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
6 |
|
|
(6) |
|
|
— |
|
| Internal transfer - accumulated depreciation |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Other - cost |
|
— |
|
|
74 |
|
|
60 |
|
|
432 |
|
|
— |
|
|
— |
|
|
566 |
|
| Other - accumulated depreciation |
|
— |
|
|
(59) |
|
|
(59) |
|
|
(434) |
|
|
— |
|
|
— |
|
|
(552) |
|
| Divestments |
|
— |
|
|
— |
|
|
(14) |
|
|
(11) |
|
|
(120) |
|
|
— |
|
|
(145) |
|
| Impairment |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Depreciation charges |
|
— |
|
|
(365) |
|
|
(258) |
|
|
(860) |
|
|
(919) |
|
|
— |
|
|
(2,402) |
|
| Depreciation of disinvestment |
|
— |
|
|
— |
|
|
8 |
|
|
6 |
|
|
120 |
|
|
— |
|
|
134 |
|
| Currency translation - cost |
|
— |
|
|
148 |
|
|
158 |
|
|
279 |
|
|
66 |
|
|
4 |
|
|
655 |
|
| Currency translation - accumulated depreciation |
|
— |
|
|
(98) |
|
|
(70) |
|
|
(183) |
|
|
(45) |
|
|
— |
|
|
(396) |
|
| Movement 2023 |
|
— |
|
|
(268) |
|
|
(115) |
|
|
(89) |
|
|
(404) |
|
|
173 |
|
|
(703) |
|
| At cost |
|
— |
|
|
4,913 |
|
|
5,546 |
|
|
9,660 |
|
|
5,131 |
|
|
179 |
|
|
25,429 |
|
| Accumulated depreciation |
|
— |
|
|
(3,388) |
|
|
(2,487) |
|
|
(6,386) |
|
|
(3,479) |
|
|
— |
|
|
(15,740) |
|
| Carrying value at December 31, 2023 |
|
— |
|
|
1,525 |
|
|
3,059 |
|
|
3,274 |
|
|
1,652 |
|
|
179 |
|
|
9,689 |
|
The Company had capital expenditures of $1.4 million and $1.4 million, mainly related to new machinery and equipment for the years ended December 31, 2023 and 2022.
For the years ended December 31, 2023 and 2022, depreciation charges on production related property, plant and equipment of $0.9 million and $1.0 million have been included in the value of inventories and an amount of $1.5 million and $1.6 million of the total depreciation costs for 2023 and 2022 have been charged to the statement of income.
The divestments during 2022 mainly relate to fully depreciated assets which were disposed.
11.RIGHT-OF-USE ASSETS
This Note provides information for leases where the Group is a lessee.
Amounts recognized in the balance sheet
The balance sheet shows the following amounts relating to lease:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
Buildings |
|
Cars |
|
Total |
| Carrying value at At cost |
22,999 |
|
|
2,380 |
|
|
25,379 |
|
| Carrying value at Accumulated depreciation |
(4,296) |
|
|
(1,140) |
|
|
(5,436) |
|
| Carrying value at January 1, 2022 |
18,703 |
|
|
1,240 |
|
|
19,943 |
|
| Additions |
14,640 |
|
|
1,741 |
|
|
16,381 |
|
| Remeasurement |
426 |
|
|
— |
|
|
426 |
|
| Divestments |
(292) |
|
|
(739) |
|
|
(1,031) |
|
| Depreciation charges |
(2,223) |
|
|
(797) |
|
|
(3,020) |
|
| Depreciation of disinvestment |
78 |
|
|
596 |
|
|
674 |
|
| Impairment |
(3,860) |
|
|
— |
|
|
(3,860) |
|
| Divestment of impaired asset |
59 |
|
|
— |
|
|
59 |
|
| Currency translation - cost |
(1,029) |
|
|
(48) |
|
|
(1,077) |
|
| Currency translation - accumulated depreciation |
197 |
|
|
61 |
|
|
258 |
|
| Movement 2022 |
7,996 |
|
|
814 |
|
|
8,810 |
|
| At cost |
32,884 |
|
|
3,334 |
|
|
36,218 |
|
| Accumulated depreciation |
(6,185) |
|
|
(1,280) |
|
|
(7,465) |
|
| Carrying value at December 31, 2022 |
26,699 |
|
|
2,054 |
|
|
28,753 |
|
| Additions |
— |
|
|
1,413 |
|
|
1,413 |
|
| Remeasurement |
1,865 |
|
|
— |
|
|
1,865 |
|
| Divestments |
— |
|
|
(756) |
|
|
(756) |
|
| Depreciation charges |
(2,913) |
|
|
(1,289) |
|
|
(4,202) |
|
| Depreciation of disinvestment |
— |
|
|
700 |
|
|
700 |
|
| Impairment |
(4,663) |
|
|
— |
|
|
(4,663) |
|
| Divestment of impaired asset |
— |
|
|
— |
|
|
— |
|
| Currency translation - cost |
873 |
|
|
18 |
|
|
891 |
|
| Currency translation - accumulated depreciation |
(213) |
|
|
(11) |
|
|
(224) |
|
| Movement 2023 |
(5,051) |
|
|
75 |
|
|
(4,976) |
|
| At cost |
30,959 |
|
|
4,009 |
|
|
34,968 |
|
| Accumulated depreciation |
(9,311) |
|
|
(1,880) |
|
|
(11,191) |
|
| Carrying value at December 31, 2023 |
21,648 |
|
|
2,129 |
|
|
23,777 |
|
Investments in buildings in 2022 primarily relate to the lease contract for the DSP facility at Pivot Park in Oss, the Netherlands. During 2022, the lease commenced and resulted in an investment of $14.6 million. Pharming remains exploring alternative utilization possibilities for assets. As a result of aforementioned, the right of use asset was impaired for an additional amount of $4.7 million in 2023 (2022: $3.9 million). The impairment assessment was conducted based on a value-in-use approach, utilizing the incremental borrowing rate of 4.38% (2022: 4.47%) as the applicable discount rate. The recoverable amount is reflecting in the book value of the asset, which stands at $5.5 million (2022: $10.7 million). The decrease in the recoverable amount is primarily attributed to the reduced expected annual sublease prices.
The remeasurements in buildings relate to adjustments in the existing right-of-use assets to reflect inflation-related higher lease payments.
The Company applies for the recognition exemption for short-term leases and leases of low-value assets. The respective lease payments are recorded in the consolidated statement of income and are immaterial to the financial statements.
Amounts recognized in the statement of income
Depreciation charges on production related right-of-use assets of $0.5 million in 2023 (2022: $0.5 million, 2021: $0.5 million) have been included in the value of inventories and an amount of $3.7 million of the total 2023 depreciation costs has been charged to the statement of income (2022: $2.6 million, 2021: $2.3 million).
The statement of income shows the following amounts relating to leases:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
|
2021 |
| Depreciation rights of use assets |
|
|
|
|
|
| Depreciation right of use buildings |
(2,380) |
|
|
(1,781) |
|
|
(1,629) |
|
| Depreciation right of use cars |
(1,284) |
|
|
(784) |
|
|
(660) |
|
| Total depreciation right of use assets |
(3,664) |
|
|
(2,565) |
|
|
(2,289) |
|
| Interest expense (Note 7) |
(1,088) |
|
|
(622) |
|
|
(795) |
|
| Total expense right of use assets |
(4,752) |
|
|
(3,187) |
|
|
(3,084) |
|
Lease charges
The non-cancellable leases at December 31, 2023 have remaining terms of between one and 14 years and generally include a clause to enable upward revision of the rental charge on an annual basis according to prevailing market conditions.
The expected lease charges after the end of the reporting year have been disclosed in Note 24. Financial risk management. Allocations of the lease charges to costs or general and administrative expenses have been based on the nature of the asset in use.
12.INVESTMENTS
12.1 INVESTMENT ACCOUNTED FOR USING THE EQUITY METHOD
The investment in BioConnection group (BioConnection) provides the Company with significant influence over BioConnection, and as such has been treated as an associate of the Group.
As at December 31, 2023, the asset relates to an investment in the ordinary shares of BioConnection Investments B.V. During the second quarter of 2022, Pharming entered into a share purchase agreement to sell a portion of its investments, following receipt of an offer for all shares in BioConnection by Gimv, a European investment company listed on Euronext Brussels. The existing shareholders (including Pharming) reached agreement with Gimv on the sale of all issued and outstanding shares to a new holding company (BioConnection Investments B.V.) incorporated by Gimv, followed by a partial re-investment by existing shareholders of the purchase price in the share capital of BioConnection Investments B.V. The re-investment relates to the purchase of ordinary shares and a preference share. The transaction diluted Pharming’s stake in BioConnection from 43.85% in 2021 to 22.98% in 2022.
The Company made an assessment on the accounting treatment of the agreement and concluded that the sale of the BioConnection ordinary shares and purchase of the BioConnection Investments B.V. ordinary shares shall be considered as a dilution of an existing equity stake in an investment accounted for using they equity method. Hence Pharming recognized the dilution of its equity stake as a reduction of the carrying amount of the investment accounted for using the equity method. The preference share is valued as an investment in debt instruments designated at FVTPL. As a result of this transaction, Pharming has received net cash proceeds of $7.3 million (EUR6.9 million) and recognized a gain of $12.2 million in 2022.
BioConnection has a share capital consisting solely of ordinary shares, which are held directly by a small group of shareholders. The proportion of ownership interest is the same as the proportion of voting rights held.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of ownership interest |
|
|
| Name of entity |
Place of business |
2023 |
2022 |
2021 |
Nature of relationship |
Measurement method |
| BioConnection Investments B.V. |
Oss, NL |
22.98 |
% |
22.98 |
% |
43.85 |
% |
Associate |
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| $ ‘000 |
|
Carrying amount |
| Name of entity |
|
2023 |
|
2022 |
|
2021 |
| BioConnection Investments B.V. |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance at January 1 |
|
2,501 |
|
|
7,201 |
|
|
7,118 |
|
|
|
|
|
|
|
|
| Movement during the year |
|
|
|
|
|
|
| Share in net profit |
|
(289) |
|
|
(1,083) |
|
|
694 |
|
| Release of financial guarantee |
|
— |
|
|
(153) |
|
|
(33) |
|
| Dilution of equity stake |
|
— |
|
|
(2,991) |
|
|
— |
|
| Currency translation |
|
73 |
|
|
(473) |
|
|
(578) |
|
|
|
|
|
|
|
|
| Balance at December 31 |
|
2,285 |
|
|
2,501 |
|
|
7,201 |
|
12.2 INVESTMENT IN DEBT INSTRUMENTS DESIGNATED AS AT FVTPL
The asset relates to the preference share as obtained as part of the agreement referred to above relating to BioConnection Investments B.V. Management made an assessment on the accounting treatment of the preference share obtained. Management concluded that the asset should be recognized as a financial asset (debt instrument) measured at initial recognition at fair value, subsequently measured at fair value through profit and loss. The fair value was calculated based on a commonly accepted valuation method, the option pricing model (“OPM”), which considers the share classes as call options on the total shareholders’ equity value according to the rights and preferences of each class of equity. The payoff profile of the share classes was analyzed through a portfolio of call options, with the total equity value of a company as the underlying asset of the options and specific terms for each option calibrated to mirror, in aggregate, the payoff profile of the share classes. Relying on the forward-looking Black-Scholes-Merton (“BSM”) financial instrument pricing framework, the OPM effectively captures the full range of potential outcomes for the share classes at exit. The OPM takes into consideration the full spectrum of risks in terms of future potential upside or downside but does not require explicit estimates of the possible future outcomes. The BSM model is commonly used to price assets on financial markets and allows to estimate the theoretical value of a call option, using six key parameters, namely the underlying equity value, strike price, time to maturity, risk free rate, expected volatility of the underlying equity and dividend yield on the underlying equity, which is a Level 3 input in terms of IFRS 13. Significant increases or decreases in equity value, volatility and time to maturity and below assumptions in isolation would result in a significantly lower or higher fair value assessment.
The following assumptions were used in the BSM model to determine the fair value of the asset:
|
|
|
|
|
|
|
|
|
|
2023 |
2022 |
| Expected time to maturity |
4 years |
5 years |
| Volatility |
50 |
% |
55 |
% |
| Risk-free interest rate |
1.99 |
% |
2.51 |
% |
The carrying amount of this investment has changed as follows:
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
2022 |
| Balance at January 1 |
6,827 |
— |
| Investment |
— |
7,933 |
| Fair value changes |
(930) |
(1,185) |
| Currency translation |
196 |
79 |
| Balance at December 31 |
6,093 |
6,827 |
Sensitivity analysis
To illustrate the exposure of the carrying value of the investment to further fair value movements as a result of changes in the economic environment, a sensitivity analysis of fair value has been prepared over the key drivers most affected by the current uncertainties. It is possible that there will be movements in these key inputs after December 31, 2023. While it is unlikely that these reported inputs would move in isolation, these sensitivities have been performed independently to illustrate the impact each individual input has on the reported fair value, and they do not represent management’s estimate at December 31, 2023.
The main assumptions in determination of the equity value are shown in below table.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Preference share BioConnection (in million US$) |
| Revenue level |
|
Fair value |
|
Discount rate |
|
Fair value |
|
EBITDA margin |
|
Fair value |
| -10.0% |
|
3.0 |
|
-2.0% |
|
6.9 |
|
-5.0% |
|
4.3 |
| -5.0% |
|
4.8 |
|
-1.0% |
|
6.5 |
|
-2.5% |
|
5.3 |
| Base case |
|
6.1 |
|
Base case |
|
6.1 |
|
Base case |
|
6.1 |
| +5.0% |
|
7.1 |
|
+1.0% |
|
5.7 |
|
+2.5% |
|
6.8 |
| +10.0% |
|
7.9 |
|
+2.0% |
|
5.4 |
|
+5.0% |
|
7.3 |
The impact of the remaining variables on the BSM model are shown in below table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Preference share BioConnection (in million US$) |
| Time to maturity |
|
Fair value |
|
Volatility |
|
Fair value |
- 2 years |
|
6.9 |
|
-10.0% |
|
6.8 |
- 1 year |
|
6.5 |
|
-5.0% |
|
6.4 |
| Base case |
|
6.1 |
|
Base Case |
|
6.1 |
+ 1 year |
|
5.8 |
|
+5.0% |
|
5.8 |
+ 2 years |
|
5.5 |
|
+10.0% |
|
5.4 |
12.3 INVESTMENT IN EQUITY INSTRUMENTS DESIGNATED AS AT FAIR VALUE THROUGH OTHER COMPREHENSIVE INCOME
The Group holds 0.54% of the ordinary share capital of Orchard Therapeutics Plc., (Orchard), a global gene therapy leader. The shares were acquired as of July 1, 2021, as part of strategic collaboration between Pharming Group NV and Orchard Therapeutics to research, develop, manufacture and commercialize OTL-105, a newly disclosed investigational ex-vivo autologous HSC gene therapy for the treatment of HAE, a life-threatening rare disorder that causes recurring swelling attacks in the face, throat, extremities and abdomen.
Under the terms of the collaboration, Pharming has been granted worldwide rights to OTL-105 and will be responsible for clinical development, regulatory filings, and commercialization of the investigational gene therapy, including associated costs. Orchard will lead the completion of IND-enabling activities and oversee manufacturing of OTL-105 during pre-clinical and clinical development, which will be funded by Pharming. In addition, both companies will explore the application of non-toxic conditioning regimen for use with OTL-105 administration. As part of the agreement, Orchard is also eligible to receive up to $189.5 million in development, regulatory and sales milestones as well as mid-single to low double-digit royalty payments on future worldwide sales.
The fair value of the shares at acquisition was $4.6 million. The upfront cash payment of $10.0 million and the premium on the share price of $2.9 million were expensed as an R&D expense for 2021. See Note 6 Expenses by Nature. The fair value of the investment at December 31, 2023 was $2.0 million.
Management does not consider that the Group is able to exercise significant influence over Orchard as the other 99.5% of the ordinary share capital is publicly traded at the Nasdaq stock exchange (Nasdaq: ORTX).
On October 5, 2023, Orchard announced it had entered into a definitive agreement under which Japanese, Kyowa Kirin Co. LTD plans to acquire Orchard for $16.00 per American Depositary Share (ADS) in cash plus an additional contingent value right (CVR) of $1.00 per ADS, for a total of $17.00 per ADS. The transaction has been completed on January 24, 2024. Based on the offer price per ADS of $16.00, Pharming has received $2.0 million for its shares held in Orchard Therapeutics in 2024. The shares have been included in our balance sheet at fair value as of 31 December 2023, being $2.0 million based on the share price at that time.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of ownership interest |
|
|
| Name of entity |
Place of business |
2023 |
2022 |
2021 |
Nature of relationship |
Measurement method |
| Orchard Therapeutics Plc. |
London, UK |
0.54% |
1.00% |
1.00% |
Investment |
Fair value |
The decrease in percentage of ownership was caused by a dilution due to a share issuance by Orchard in March 2023. The fair value as at December 31, 2023 was determined on the basis of the trading price as at that date.
The fair value as at December 31, 2023 was determined on the basis of the trading price as at that date.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| $ ‘000 |
|
Carrying amount |
| Name of entity |
|
2023 |
|
2022 |
|
2021 |
| Orchard Therapeutics Plc. |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance at January 1 |
|
403 |
|
|
1,449 |
|
|
— |
|
|
|
|
|
|
|
|
| Movement during the year |
|
|
|
|
|
|
| Initial recognition |
|
— |
|
|
— |
|
|
4,589 |
|
| Fair value adjustments through OCI |
|
1,573 |
|
|
(950) |
|
|
(3,077) |
|
| Currency Translation |
|
44 |
|
|
(96) |
|
|
(63) |
|
|
|
|
|
|
|
|
| Balance at December 31 |
|
2,020 |
|
|
403 |
|
|
1,449 |
|
13.MARKETABLE SECURITIES
Marketable securities consist of euro denominated readily convertible S&P AAA-rated government treasury certificates with a maturity of six months or less from the date of acquisition and are classified as held-to-maturity. The Marketable securities are measured at amortized costs and amount to $151.7 million in 2023. This includes accrued interest of $0.7 million.
We have considered the expected credit loss and recognized no impairment losses, due to the AAA credit ratings. Reference is made to note 24. Financial risk management showing the difference between the carrying amount and the fair value.
14.RESTRICTED CASH, CASH AND CASH EQUIVALENTS
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Restricted cash (non-current) |
1,528 |
|
|
1,099 |
|
| Restricted cash (current) |
— |
|
|
213 |
|
| Cash and cash equivalents |
61,741 |
|
|
207,342 |
|
| Total restricted cash, cash and cash equivalents |
63,269 |
|
|
208,654 |
|
Cash and cash equivalents comprises of cash and short-term, highly liquid investments that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value, except for restricted cash, which amounts to $1.5 million and $1.3 million in 2023 and 2022 respectively. Restricted cash includes a deposit for rent which is considered long-term.
For purposes of the cash flow statement restricted cash and marketable securities are not considered as ''cash and cash equivalents''.
15.INVENTORIES
Inventories mainly include batches RUCONEST® and Joenja® and work in progress available for production of RUCONEST® and Joenja®.
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Finished goods |
18,349 |
|
|
12,460 |
|
| Work in progress |
37,706 |
|
|
29,553 |
|
| Raw materials |
705 |
|
|
313 |
|
| Balance at December 31 |
56,760 |
|
|
42,326 |
|
Changes in the adjustment to net realizable value:
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Balance at January 1 |
(1,971) |
|
|
(2,448) |
|
| Addition to impairment |
(3,878) |
|
|
(164) |
|
| Release of impairment |
— |
|
|
312 |
|
| Usage of impairment |
1,673 |
|
|
195 |
|
| Currency translation |
(100) |
|
|
134 |
|
| Balance at December 31 |
(4,276) |
|
|
(1,971) |
|
The inventory valuation at December 31, 2023 of $56.8 million (2022: $42.3 million) is stated net of an impairment of $4.3 million and $2.0 million for the years ended December 31, 2023 and 2022.The impairment primarily relates to products no longer eligible for commercial sales.
Inventories are available for use in commercial, pre-clinical and clinical activities. Estimates have been made with respect to the ultimate use or sale of product, taking into account current and expected sales as well as pre-clinical and clinical programs. These estimates are reflected in the additions to the impairment. The releases to the impairment relate to amendments to the estimates as a result of the fact that actual sales can differ from forecasted sales and the fact that vials allocated to pre-clinical and clinical programs can be returned to inventory. The costs of vials used in preclinical and clinical programs are presented under the research and development costs. Usage of impairment relates to the destruction of inventory previously impaired.
Cost of inventories included in the costs of sales in 2023 amounted $21.4 million (2022: $17.4 million; 2021: $19.1 million). The main portions of inventories at December 31, 2023 have expiration dates starting beyond 2024 and are generally expected to be sold and/or used before expiration.
16.TRADE AND OTHER RECEIVABLES
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Trade receivables |
35,408 |
|
|
20,964 |
|
| Prepaid expenses |
3,543 |
|
|
2,288 |
|
| Value added tax |
3,804 |
|
|
1,453 |
|
| Other receivables |
2,145 |
|
|
1,117 |
|
| Taxes and social securities |
1,258 |
|
|
1,797 |
|
| Balance at December 31 |
46,158 |
|
|
27,619 |
|
Trade receivables are amounts due from customers for goods sold in the ordinary course of business. They are generally due for settlement within 30-60 days and therefore are all classified as current. The Company’s outstanding trade receivables are mainly related to the sales in the United States. The increase in trade receivables relates to timing of customer orders and payments around year-end.
The Company did not recognize any expected credit losses. Pharming measures the loss allowance for trade receivables at an amount equal to lifetime ECL. The expected credit losses on trade receivables are estimated using a provision matrix by reference to past default experience of the debtor and an analysis of the debtor’s current financial position, adjusted for factors that are specific to the debtors, general economic conditions of the industry in which the debtors operate and an assessment of both the current as well as the forecast direction of conditions at the reporting date. Pharming has a limited number of customers with long term relationships, without a history of shortfalls. As a result no loss allowance for expected credit losses is recognized.
Due to the short-term nature of the current receivables, their carrying amount is considered to be the same as their fair value.
17.CONVERTIBLE BONDS
Recognition and movements of the convertible bonds were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Balance at January 1 |
133,386 |
|
|
140,886 |
|
| Interest paid (cash flow) |
(4,046) |
|
|
(3,952) |
|
| Amortization transaction cost |
830 |
|
|
784 |
|
| Accrued interest |
4,046 |
|
|
3,952 |
|
| Currency translation |
4,206 |
|
|
(8,284) |
|
| Balance at December 31 |
138,422 |
|
|
133,386 |
|
| - Current portion |
1,824 |
|
|
1,768 |
|
| - Non-current portion |
136,598 |
|
|
131,618 |
|
On January 21, 2020, the Company issued €125 million aggregate principal amount of 3.00% convertible bonds due 2025. The bonds were issued at par and bear interest at a rate of 3.00% per annum payable semi-annually in arrears in equal installments. Unless previously converted, redeemed or purchased and cancelled, the bonds will mature on January 21, 2025.
The bonds are convertible into the Company’s ordinary shares at an initial conversion price of €2.0028. This initial conversion price is subject to customary adjustment provisions. The number of ordinary shares initially underlying the bonds is 62,412,622. Any adjustment to the conversion price resulting in an increase in the number of conversion shares may require the Company to obtain further authorization from the Company’s shareholders to issue shares, grant rights to subscribe for shares and exclude preemptive rights. The Company has the option to redeem all, but not some only, of the outstanding bonds in cash at par plus accrued interest at any time, (a) if, on or after February 13, 2023, the parity value on each of at least 20 trading days in a period of 30 consecutive trading days shall have exceeded 130% of the principal amount or (b) if, at any time, 85% or more of the aggregate principal amount of the bonds originally issued shall have been previously converted and / or repurchased and cancelled.
The convertible bonds comprise of two components. The first component is a financial liability, which represents our contractual obligation to deliver cash or another financial asset for payment of interest and principal, if not converted. The second component is an equity instrument as it represents a written call option granting the holder the right, for a specified period of time, to convert it into a fixed number of the Company’s ordinary shares.
The fair value of the consideration in respect of the liability components is measured at the fair value of a similar liability that does not have any associated equity conversion option (IFRS 9 paragraph 5.1.1). This is the liability component’s carrying amount at initial recognition.
The equity component will be measured at the residual difference between the nominal value and the fair value of a similar liability that does not have any associated equity conversion option (IAS 32 paragraph 31). The original equity component as recorded at initial recognition amounts to $1.6 million.
18.LEASES
Lease liabilities can be specified as follows:
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Balance at January 1 |
33,308 |
|
|
20,875 |
|
| Additions |
1,295 |
|
|
15,822 |
|
| Remeasurement |
1,865 |
|
|
426 |
|
| Interest expense accrued |
1,193 |
|
|
718 |
|
| Payments of lease liabilities |
(5,126) |
|
|
(3,311) |
|
| Other movements |
(319) |
|
|
(348) |
|
| Currency translation |
907 |
|
|
(874) |
|
| Balance at December 31 |
33,123 |
|
|
33,308 |
|
| - Current portion |
3,616 |
|
|
3,465 |
|
| - Non-current portion |
29,507 |
|
|
29,843 |
|
Additions in 2022 primarily relate to new lease contracts for our operational facilities in the Netherlands. Additions in 2023 solely relate to newly leased cars. The remeasurement reflects inflation related higher lease payments on buildings.
Future minimum lease payments as at December 31, 2023 and 2022 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
| Amounts in $ ‘000 |
Minimum payments |
|
Present value of payments |
|
Minimum payments |
|
Present value of payments |
| Within one year |
5,071 |
|
4,995 |
|
4,644 |
|
4,535 |
| After one year but not more than five years |
16,024 |
|
14,369 |
|
15,157 |
|
13,582 |
| More than five years |
18,996 |
|
14,104 |
|
20,890 |
|
15,191 |
| Balance at December 31 |
40,091 |
|
33,468 |
|
40,691 |
|
33,308 |
19.TRADE AND OTHER PAYABLE
Trade and other payables as at December 31, 2023 and 2022 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
| Accounts payable |
16,022 |
|
|
8,753 |
|
| Taxes and social security |
6,234 |
|
|
2,099 |
|
| Accruals for employees |
16,019 |
|
|
12,139 |
|
| Accruals for rebates and discounts |
11,643 |
|
|
10,490 |
|
| Accrual for production |
6,976 |
|
|
8,175 |
|
| Other accruals |
15,634 |
|
|
12,809 |
|
| Balance at December 31 |
72,528 |
|
|
54,465 |
|
The increase in accounts payable is mainly due to timing of payments. The accrual for rebates and discounts has increased, mainly due to the increase of revenues and timing of settlements. Accruals for employees mainly relate to bonuses for employees, holiday allowances and non-taken vacation days and increased due to an increase in the number of employees. Finally, the other accruals relate to general operating expenses for which no invoice was received yet. The increase is mainly related to timing of invoicing by Pharming's suppliers.
20.SHARE-BASED COMPENSATION
The remuneration policy for the Board of Directors was adopted by our shareholders on December 11, 2020 and governs the remuneration of both the Executive and the Non-Executive Directors, hereafter referred to as the Remuneration Policy. In accordance with Dutch law, the policy must be submitted to our shareholders for adoption every four years.
The Policy refers to an undefined number of Executive Directors and Non-Executive Directors. Since May 19, 2021, the Board of Directors is composed of one Executive Director (i.e., the CEO) and seven Non-Executive Directors. In case of future appointments of additional Executive Directors, the Policy shall also be applicable to the remuneration packages for these additional Directors, if any, in accordance with the terms thereof. Therefore, any reference below to Executive Director in the singular also includes the plural, and vice-versa, subject to more restrictive deviations in the Policy and except for specific references to the CEO.
The remuneration packages of the individual Directors are determined by the Board of Directors, without the involvement of the Executive Director in the deliberations and decision-making concerning his own remuneration, and each time within the restrictions set by the remuneration policy.
Arrangements in the form of shares or rights to subscribe for shares will each time remain subject to the approval of the shareholders at the General Meeting, notwithstanding the adopted policy. On December 11, 2020, the shareholders approved the proposals that were submitted accordingly for the new long-term incentive program for the Executive Director, as described in the Remuneration Policy, and the one-off transition arrangement for the implementation of that new program. Our shareholders also authorized the Board of Directors, for a period of eighteen months, as the company body authorized to grant and issue the ordinary shares to the Executive Director under the new long-term incentive program and the one-off transition arrangement, respectively, and to exclude any preemptive rights of existing shareholders in connection with these issuances.
The total expense recognized for the years ended December 31, 2023 and 2022 for share-based payment plans amounts to $9.3 million and $6.4 million. The total expense recognized in 2021 for share-based payment plans amounts to $9.1 million.
The total expenses for share based payment plans in 2023, 2022 and 2021 is specified as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
|
|
|
|
|
| Share-based compensation (in $ ‘000) |
2023 |
|
2022 |
|
2021 |
| Non-executive directors' remuneration |
246 |
|
|
234 |
|
|
288 |
|
| Employee options |
1,654 |
|
|
2,156 |
|
|
3,975 |
|
| Long term incentive plan |
4,006 |
|
|
3,528 |
|
|
4,793 |
|
| Restricted stock units |
3,345 |
|
|
474 |
|
|
— |
|
| Balance at December 31 |
9,251 |
|
|
6,392 |
|
|
9,056 |
|
The employee options expense decreased due to a change in the employee share-based compensation plans where since 2022 RSU's have been granted instead of employee options. No material new employee option grants were applicable for 2023. Long-term incentive plan expenses increased mainly due to the addition of a member to the executive committee during 2023. The restricted stock units expense increased significantly as the program was introduced in 2022 and is now active for the full year, while in previous year, it was only active for 4Q 2022.
20.1 Models and assumptions
Models and assumptions
IFRS 2 describes a hierarchy of permitted valuation methods for share-based payment transactions. If possible, an entity should use market prices at measurement date to determine the fair value of its equity instruments. If market prices are unavailable, as is the case with Pharming’s option plans and long-term incentive plan, the entity shall estimate the fair value of the equity instruments granted. A valuation technique should be used to estimate the value or price of those equity instruments as it would have been at the measurement date in an arm’s length transaction between knowledgeable, willing parties.
The valuation technique shall be consistent with generally accepted valuation methodologies for pricing financial instruments and shall incorporate all factors and assumptions that knowledgeable market participants would consider in setting the price.
Whatever pricing model is selected, it should, as a minimum, take into account the following elements:
•The exercise price of the option;
•The expected time to maturity of the option;
•The current price of the underlying shares;
•The expected volatility of the share price;
•The dividends expected on the shares;
•The risk-free interest rate for the expected time to maturity of the option.
Models and assumptions option plans
The costs of option plans are measured by reference to the fair value of the options at the grant date of the option.
The six elements above are all incorporated in the Black-Scholes model used to determine the fair value of options. The exercise price of the option and the share price are known at grant date. Volatility is based on the historical end-of-month closing share prices over a period prior to the option grant date being equal to the expected option life, with a minimum of three years. It is assumed no dividend payments are expected.
The total number of shares with respect to which options may be granted pursuant to the option plans accumulated, shall be determined by Pharming, but shall not exceed 10% of all issued and outstanding shares of Pharming on a diluted basis. Shares transferred or to be transferred, upon exercise of options shall be applied to reduce the maximum number of shares reserved under the plans. Unexercised options can be re-used for granting of options under the option plans.
Pharming may grant options to a member of the Executive Committee or an employee:
•At the time of a performance review;
•Only in relation to an individual: a date within the first month of his or her employment;
•In case of an extraordinary achievement;
•In case of a promotion to a new function within Pharming.
The option exercise price is the price of the Pharming shares on the stock exchange on the trading day prior to the date of grant. Vested options can be exercised at any time within five years following the date of grant. Unexercised options shall be deemed lapsed and shall cease to exist automatically after five years. Exercise of options is subject to compliance with laws and regulations in The Netherlands. Exercise of options is including withholding taxes. Each option is equal to one share unless otherwise stated. Options are not applicable for early retirement.
The following assumptions were used in the Black-Scholes model to determine the fair value of options at grant date:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
|
2021 |
| Expected time to maturity |
1-4 years |
|
1-4 years |
|
1-4 years |
| Volatility |
38% - 46% |
|
36% - 50% |
|
47% - 57% |
| Risk-free interest rate |
2.20% - 2.68% |
|
(0.48)% - 2.49% |
|
(0.52)% - (0.03)% |
Option plan employees
Article 2.1 of the option plan for employees’ states: Pharming may grant options to any employee. The criteria for the granting of the options up to December 11, 2020 was determined by the Board of Supervisory Directors of Pharming, at its sole discretion. Up to December 11, 2020, the Board of Management proposed (i) whether the criteria for granting an option have been met by a potential participant and (ii) the number of options to be granted. As from December 11, 2020, the execution of the Company’s remuneration policy and other benefits policies and incentive programs, as approved by the Board of Directors (to the extent required), for all staff members of the Company and its subsidiaries, excluding the CEO and the other members of the Executive Committee, is delegated to the CEO.
Article 4.4 of the employee option plan deals with the vesting scheme of employee options and reads as follows: in case of the termination of the employment of a participant, except for retirement and death, Pharming at its sole discretion is entitled to decide that the options of the participant shall lapse. The following schedule shall apply for the cancellation:
•In the event of termination of employment within one year as of a date of grant, all options shall lapse;
•In the event of termination of employment after the first year as of a date of grant, all options, less 1/4 of the number of options shall be lapsed. The number of options to be cancelled decreases for each month that the employment continued for more than one year as of that date of grant by 1/48 of the number of options granted of that date of grant.
Models and assumption Long Term Incentive Plan
For the long-term incentive plan, the following elements of Pharming and/or the peer group are included in order to determine the fair value of long-term incentive plan share awards, using Monte Carlo simulation:
•Start and end date of performance period;
•The grant date;
•The share prices;
•Exchange rates;
•Expected volatilities;
•Expected correlations;
•Expected dividend yields;
•Risk free interest rates.
Volatilities are based on the historical end-of-month closing share prices over the 3 years.
Correlations are based on 3 years of historical correlations based on end-of-month closing quotes, taking into account exchange rates. Expected dividend yields for peers and risk-free interest rates (depending on the currency) are obtained from Bloomberg.
Under the LTIP, restricted shares are granted conditionally each year with shares vesting based on the market condition in which the total shareholder return performance of the Pharming share is compared to the total shareholder return of a peer group of other European biotech companies.
During 2023, there were no LTIP grants other than the grants for the executive directors as disclosed below.
Upon a change of control, all remaining LTIP shares will vest automatically.
Long Term Incentive Plan for the Executive Directors
As part of the Remuneration Policy, the Long Term Incentive Program is applicable to Executive Directors and has been aligned with prevailing “best practices” and is performance related only. For the Executive Directors, the on-target value of the shares to be awarded under the newly designed LTI Program, as described in the remuneration policy, is set at 300% of the gross annual salary for the CEO (representing 50% below the lowest quartile of the U.S. benchmark group and just below the top quartile of the EU benchmark group for the executive directors) and 200% for other Executive Directors and Officers (representing between 20% and 30% below the lowest quartile of the U.S. benchmark group and just in the top quartile of the EU benchmark group for the Executive Directors).
The maximum value of the shares that can vest under the LTI program is set at 450% of the gross annual salary for the CEO and 300% for other Executive Directors and Officers. Executive Directors are required to retain the shares awarded under the LTI program for a minimum of five years from the date of grant.
The shares granted to the Executive Directors under the LTI program will vest in five years after the grant date, subject to the achievement of the targets set by the Board of Directors, upon proposal of the Remuneration Committee, for the three-year performance period (i.e., double-trigger vesting), their relative weightings and the pay-out limits. All shares awarded will be subject to a retention period of five years from the date of grant (i.e., two years after vesting), in accordance with the best practice provisions of the DCGC.
The performance objectives include the Total Shareholder Return (40% weighing) and the achievement of long-term strategy oriented objectives (60% weighing). The peer group used to determine the Total Shareholder Return is composed of the companies included in the AScX Index and the NASDAQ Biotechnology Index, represented by the IBB ETF, respectively, equally weighted, at the time of the determination.
The thresholds and payout percentages for the LTI program are given by the following table, as to be determined for each of the AScX and IBB indices separately (each weighted at of pay-out):
|
|
|
|
|
|
| TSR equal to index |
80%pay-out |
TSR 10% above index |
90% pay-out |
TSR 20% above index |
100% pay-out |
TSR 40% above index |
110% pay-out |
TSR 60% above index |
120% pay-out |
TSR 80% above index |
130% pay-out |
TSR 100% above index |
150% pay-out |
| TSR below index |
0% pay-out |
The range of assumptions used in the Monte Carlo simulation to determine the fair value of long-term incentive plan share awards at grant date were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
2021 |
| Volatilities |
42% |
|
46% |
49% |
| Risk-free interest rates |
2.34% |
|
0.61% |
(0.554)% - (0.554)% |
| Dividend yields |
—% |
|
—% |
—% |
Restricted Stock Units
This Plan is effective as of October 26, 2022, and shall be executed in compliance with the Articles of Association and applicable law and concerns Pharming's (senior) management. The RSU plans are not applicable for the board of directors, nor the executive committee. For each participant, the RSU’s granted to them will vest in four equal tranches of twelve months, provided that at the time of vesting such participant is still an employee. No performance criteria are applicable to this plan. The fair value of the grant is, in line with IFRS 2, the actual share price at date of the grant. The relating expense will be charged to Pharming's results over the vesting for the following tranches:
a.a first tranche of 25% of the RSU’s granted, vesting twelve months after the Vesting Commencement Date;
b.a second tranche of 25% of the RSU’s granted, vesting two years after the Vesting Commencement Date;
c.a third tranche of 25% of the RSU’s granted, vesting three years after the Vesting Commencement Date; and
d.a fourth tranche of 25% of the RSU’s granted, vesting four years after the Vesting Commencement Date.
One-off transition arrangement for the CEO
In 2020, the implementation of a new three-year vesting scheme under the LTIP had a major impact on the remuneration packages of existing Executive Directors for the 2020 to 2023 period, as the Executive Directors’ packages feature annual option and share grants. The share-based compensation under these packages and plans over this three-year period would have resulted in three option grants, with guaranteed vesting of a total of 8,400,000 options for the CEO on the basis of continued tenure over the three-year period. In addition, the CEO would have been eligible for three annual restricted share grants pursuant to the LTIP of up to 30% of the base salary.
To mitigate the described impact, the Company has agreed to a one-off transition arrangement with the CEO as approved at the General Meeting of Shareholders on December 11, 2020. This one-off transition arrangement provides for (i) the conversion of the total number of 8,400,000 options for the CEO (i.e., the total number of share options that was expected to be granted in 2021, 2022 and 2023 without the arrangement) into one grant for a total number of 4,200,000 shares for 2020, which vesting will be governed by the performance-based criteria of the new LTI program, and (ii) the vesting of the performance shares in three annual tranches in the first quarter of 2021, 2022 and 2023, subject to the performance-based criteria of the new LTI program for Executive Directors as described above in the Long Term Incentive Plan for the Executive Directors paragraph.
In addition, the grant and each of the three potential vestings of the granted shares under the Long-term Incentive One-Off Arrangement is subject to:
•a five year retention period for the granted shares;
•the annual pro-rata satisfaction upon vesting of the set long-term performance targets, as determined by the Board of Directors; and
•the other terms and conditions applicable to the LTI Program pursuant to the Remuneration Policy for the Board of Directors dated December 11, 2020.
Pursuant to the one-off transition arrangement, the CEO has waived all his rights for the grant of restricted shares and option rights, respectively, under the LTIP and the existing option plans for the financial year 2020. On December 22, 2020, a total number of 4,200,000 (restricted) shares was granted to the CEO in accordance with the terms of the one-off transition arrangement.
Option plans
An overview of activity in the number of options for 2023 is as follows (please also refer to Note 25. Earnings per share and diluted shares in respect of movements since the reporting date)(note that the dollar weighted average exercise price is translated using the closing exchange rate for the respective year (2023: 1:1.1002)):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
|
2021 |
|
Number |
|
Weighted Average Exercise Price ($) |
|
Number |
|
Weighted Average Exercise Price ($) |
|
Number |
|
Weighted Average Exercise Price ($) |
| Balance at January 1 |
47,596,801 |
|
|
0.897 |
|
|
52,789,478 |
|
0.911 |
|
|
50,106,488 |
|
0.909 |
|
| Expired |
(205,000) |
|
|
0.847 |
|
|
— |
|
|
— |
|
|
— |
|
— |
|
| Forfeited |
(1,423,375) |
|
|
0.992 |
|
|
(3,660,928) |
|
0.847 |
|
|
(946,738) |
|
1.046 |
|
| Granted |
270,000 |
|
|
1.349 |
|
|
4,801,938 |
|
0.902 |
|
|
12,081,000 |
|
0.931 |
|
| Exercised |
(11,756,114) |
|
|
0.857 |
|
|
(6,333,687) |
|
0.599 |
|
|
(8,451,272) |
|
0.520 |
|
| Balance at December 31 |
34,482,312 |
|
|
0.952 |
|
|
47,596,801 |
|
0.897 |
|
|
52,789,478 |
|
0.911 |
|
| - Vested |
9,284,834 |
|
|
0.856 |
|
|
8,687,584 |
|
0.844 |
|
|
21,388,237 |
|
0.833 |
|
| - Unvested |
25,197,478 |
|
|
0.987 |
|
|
38,909,217 |
|
0.910 |
|
|
31,401,241 |
|
0.966 |
|
Exercised options 2023
In 2023, a total of 11,756,114 options have been exercised with an average exercise price of $0.857. In 2022, a total of 6,333,687 options have been exercised with an average exercise price of $0.599. In 2021, a total of 8,451,272 options have been exercised with an average exercise price of $0.520.
All options outstanding at December 31, 2023 are exercisable with the exception of the unvested options granted to the employees still in service. The 2023 share options for the employees vest after one year under the condition the employees are still in service at vesting date.
Exercise prices of options outstanding at December 31, 2023 and the exercise values are in the following ranges (note that the exercise value in $ is translated using the closing exchange rate for the respective year (2023: 1:1.1002)):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
|
2021 |
| Exercise prices in US$ |
Number |
|
Exercise value
in US$’000 |
|
Number |
|
Exercise value
in US$’000 |
|
Number |
|
Exercise value
in US$’000 |
0.28 - 0.57 |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
3,482,428 |
|
1,322 |
|
0.57 – 0.85 |
6,739,000 |
|
4,967 |
|
|
26,796,675 |
|
21,847 |
|
|
12,290,925 |
|
10,155 |
|
0.85 – 2.83 |
27,743,312 |
|
24,862 |
|
|
20,800,126 |
|
20,895 |
|
|
37,016,125 |
|
36,646 |
|
| Balance at December 31 |
34,482,312 |
|
29,828 |
|
|
47,596,801 |
|
42,742 |
|
|
52,789,478 |
|
48,123 |
|
Granted options
In 2023, the Company granted 270,000 options to employees with a weighted average exercise price of $1.349, fair values for options granted in 2023 were in the range of $0.223 - $0.581. In 2022, the Company granted 4,801,938 options to employees with a weighted average exercise price of $0.902; fair values for options granted in 2022 were in the range of $0.092 - 0,489. In 2021, the Company granted 12,081,000 options to employees with a weighted average exercise price of $0.931; fair values for options granted in 2021 were in the range of $0.891 - $1.292.
Long Term Incentive Plan
An overview of the number of LTIP shares granted in 2020-2023 and in total as well as the fair value per share award is as follows (note that the fair value per share award in $ is translated using the closing exchange rate for the respective year (2023: 1:1.1002)):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Participant category |
2023 |
|
2022 |
|
2021 |
|
2020 |
|
Total |
| Executive Members of the Board of Directors |
1,681,570 |
|
|
2,363,455 |
|
|
1,337,888 |
|
|
— |
|
|
5,382,913 |
|
| Executive Committee |
4,221,870 |
|
|
5,816,083 |
|
|
6,301,400 |
|
|
105,000 |
|
|
16,444,353 |
|
| Senior managers |
— |
|
|
— |
|
|
812,500 |
|
|
930,000 |
|
|
1,742,500 |
|
| Total |
5,903,440 |
|
|
8,179,538 |
|
|
8,451,788 |
|
|
1,035,000 |
|
|
23,569,766 |
|
| Fair value per share award ($) |
0.880 |
|
|
0.517 |
|
|
0.887 |
|
|
0.923 |
|
|
|
The following table provides an overview of LTIP shares granted, forfeited or issued in 2020-2023 as well as the number of LTIP shares reserved at 31 December 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Participant category |
Granted |
|
Issued |
|
Forfeited / Unvested |
|
Reserved at December 31, 2023 |
| Executive Members of the Board of Directors |
5,382,913 |
|
— |
|
|
— |
|
|
5,382,913 |
|
| Executive Committee |
16,444,353 |
|
(1,261,595) |
|
(3,708,270) |
|
11,474,488 |
|
| Senior managers |
1,742,500 |
|
(36,654) |
|
(1,052,346) |
|
|
653,500 |
|
| Total |
23,569,766 |
|
|
(1,298,249) |
|
|
(4,760,616) |
|
|
17,510,901 |
|
Restricted stock units
An overview of the granted RSU's to the Company's (senior) managers, as well as the number of RSU's reserved at 31 December 2023 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Grant year |
Granted |
|
Issued |
|
Forfeited / Unvested |
|
Reserved at December 31, 2023 |
| 2022 |
4,931,000 |
|
(1,155,936) |
|
(357,250) |
|
3,417,814 |
|
| 2023 |
7,779,250 |
|
— |
|
|
(10,000) |
|
|
7,769,250 |
|
| Total |
12,710,250 |
|
|
(1,155,936) |
|
|
(367,250) |
|
|
11,187,064 |
|
Transition arrangement for the Chief Executive Officer, or CEO
On December 22, 2020, a total number of 4,200,000 (restricted) shares was granted to the CEO in accordance with the terms of the one-off transition arrangement. These shares vested in three equal annual tranches in the first quarter of 2021, the first quarter of 2022 and the first quarter of 2023, subject to the pro-rata achievement of the long-term targets under the new LTI program.
The third year of the 3-year performance period for the 2021 share grant pursuant to the LTI one-off transition arrangement, ended on December 31, 2022. Accordingly, the Board of Directors, upon a recommendation of the Remuneration Committee, determined in the first quarter of 2023 the vesting of the second annual tranche of the total number of 4,200,000 shares conditionally granted to the CEO (i.e., 1,400,000 shares).
The performance on both the TSR and the strategic corporate objectives, applying the respective weightings, led to the following vesting level under the One-Off Transition Arrangement for the CEO (i.e., second annual tranche of 1,400,000 shares):
|
|
|
|
|
|
|
|
|
|
|
|
| Metric definition |
Achievement |
Weighting |
Vesting level |
| TSR |
115 |
% |
40 |
% |
46 |
% |
| Strategic Objectives |
90 |
% |
60 |
% |
54 |
% |
| Total |
|
100 |
% |
100 |
% |
In accordance with the resulting 100% vesting level, a total number of 1,400,000 shares vested in 2023 for the CEO for the third annual tranche of the shares granted under the LTI One-Off Transition Arrangement. These shares are subject to a retention period of five years.
21. BOARD OF DIRECTORS
In connection with the listing of our ADSs on Nasdaq, we converted our two-tier board structure into a one-tier board structure, with a single board of directors consisting of the executive director and non-executive directors. The new structure became effective on December 11, 2020. Since that date, the Board of Directors is jointly responsible for the management of the Company. The daily management of the Company and the execution of the strategy are entrusted to the CEO, as the only Executive Director. The CEO is supported by the non-statutory Executive Committee in the execution of his tasks and responsibilities. The Non-Executive Directors share statutory management responsibility, but shall focus on the supervision on the policy and functioning of the performance of the duties by the Executive Director and the Company’s general state of affairs. The Non-Executive Directors would focus on the supervision on the policy and functioning of the performance of the duties by the Executive Directors and the Company’s general state of affairs.
Dr. S. de Vries is the Company’s sole Executive member of the Board of Directors and is continuing to be the CEO.
The Board of Directors has the following members:
|
|
|
|
|
|
|
|
|
| Dr. R. Peters |
Chair of the Board of Directors and Non-Executive Board Member |
Appointed September 25, 2023 |
| Ms. D. Jorn |
Vice Chair of the Board of Directors and Non-Executive Board Member |
|
| Ms. B. Yanni |
Non-Executive Board Member |
|
| Dr. M. Pykett |
Non-Executive Board Member |
|
| Ms. J. van der Meijs |
Non-Executive Board Member |
|
| Mr. L. Kruimer |
Non-Executive Board Member |
|
| Mr. S. Baert |
Non-Executive Board Member |
|
| Dr. S. de Vries |
Executive Board Member and Chief Executive Officer |
|
Non-Executive members Board of Directors
Remuneration
For 2023 the annual compensation of the non-executive members of the Board of Directors was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Responsibility |
|
Cash in Euros
(per annum)
|
|
Ordinary shares in Euros **
(per annum)
|
|
Cash in U.S. dollars
(per annum) |
|
Ordinary shares in U.S. dollars *
(per annum) |
| Chair of the Board of Directors |
|
90,000* |
|
40,000 |
|
97,110 |
|
43,160 |
| Non-Executive Director |
|
45,000 |
|
30,000 |
|
48,555 |
|
32,370 |
| Chair Audit Committee |
|
9,000 |
|
|
|
9,711 |
|
|
| Member Audit Committee |
|
3,000 |
|
|
|
3,237 |
|
|
| Chair Remuneration Committee |
|
6,000 |
|
|
|
6,474 |
|
|
| Member Remuneration Committee |
|
3,000 |
|
|
|
3,237 |
|
|
| Chair of the Transaction Committee |
|
6,000 |
|
|
|
6,474 |
|
|
| Member of the Transaction Committee |
|
3,000 |
|
|
|
3,237 |
|
|
| Chair Governance Committee |
|
6,000 |
|
|
|
6,474 |
|
|
| Member Governance Committee |
|
3,000 |
|
|
|
3,237 |
|
|
*Effective September 25, 2023. Until September 25, 2023: EUR 65,000 ($70,135)
**All shares to be valued at the 20 day VWAP preceding the Annual General Meeting of Shareholders, without further restrictions or grant.
An additional compensation of €1,000 ($1,100) per day in case of extraordinary activities, as determined by the Chair of the Board of Directors. Compensation of the Non-Executive members of the Board of Directors and / or of former members of the Supervisory Board of Directors for 2023, 2022 and 2021 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
Year |
|
Cash |
|
Share-Based Payment |
|
Total |
| Dr. Richard Peters |
2023 |
|
26 |
|
|
20 |
|
|
46 |
|
|
2022 |
|
— |
|
|
— |
|
|
— |
|
|
2021 |
|
— |
|
|
— |
|
|
— |
|
| Mr. Paul Sekhri |
2023 |
|
55 |
|
|
32 |
|
|
87 |
|
|
2022 |
|
72 |
|
|
42 |
|
|
114 |
|
|
2021 |
|
77 |
|
|
55 |
|
|
132 |
|
| Ms. Deborah Jorn |
2023 |
|
55 |
|
|
32 |
|
|
87 |
|
|
2022 |
|
55 |
|
|
32 |
|
|
87 |
|
|
2021 |
|
64 |
|
|
42 |
|
|
106 |
|
| Ms. Barbara Yanni |
2023 |
|
62 |
|
|
32 |
|
|
94 |
|
|
2022 |
|
53 |
|
|
32 |
|
|
85 |
|
|
2021 |
|
60 |
|
|
36 |
|
|
96 |
|
| Dr. Mark Pykett |
2023 |
|
55 |
|
|
32 |
|
87 |
|
|
2022 |
|
50 |
|
|
32 |
|
|
82 |
|
|
2021 |
|
57 |
|
|
36 |
|
|
93 |
|
| Ms. Jabine van der Meijs |
2023 |
|
62 |
|
|
32 |
|
94 |
|
|
2022 |
|
57 |
|
|
32 |
|
|
89 |
|
|
2021 |
|
47 |
|
|
24 |
|
|
71 |
|
| Mr. Leonard Kruimer |
2023 |
|
58 |
|
|
32 |
|
90 |
|
|
2022 |
|
57 |
|
|
32 |
|
|
89 |
|
|
2021 |
|
47 |
|
|
24 |
|
|
71 |
|
| Mr. Steven Baert |
2023 |
|
58 |
|
|
32 |
|
90 |
|
|
2022 |
|
55 |
|
|
32 |
|
|
87 |
|
|
2021 |
|
45 |
|
|
24 |
|
|
69 |
|
| Mr. Barrie Ward |
2023 |
|
— |
|
|
— |
|
|
— |
|
|
2022 |
|
— |
|
|
— |
|
|
— |
|
|
2021 |
|
23 |
|
|
20 |
|
|
43 |
|
| Mr. Juergen Ernst |
2023 |
|
— |
|
|
— |
|
|
— |
|
|
2022 |
|
— |
|
|
— |
|
|
— |
|
|
2021 |
|
— |
|
|
6 |
|
|
6 |
|
| Mr. Aad de Winter |
2023 |
|
— |
|
|
— |
|
|
— |
|
|
2022 |
|
— |
|
|
— |
|
|
— |
|
|
2021 |
|
26 |
|
|
21 |
|
|
47 |
|
| Total |
2023 |
|
431 |
|
|
244 |
|
|
675 |
|
|
2022 |
|
399 |
|
|
234 |
|
|
633 |
|
|
2021 |
|
446 |
|
|
288 |
|
|
734 |
|
Shares, options and warrants
Shares
At December 31, 2023, the Non-Executive members of the Board of Directors held the following numbers of shares:
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares |
| Dr. Richard Peters |
|
17,613 |
| Ms. Deborah Jorn |
|
127,714 |
| Ms. Barbara Yanni |
|
112,123 |
| Dr. Mark Pykett |
|
112,123 |
| Ms. Jabine van der Meijs |
|
87,285 |
| Mr. Leonard Kruimer |
|
87,285 |
| Mr. Steven Baert |
|
87,285 |
| Total |
|
631,428 |
All shares held by the Non-Executive members of the Board of Directors are unrestricted.
Loans or guarantees
During 2023, the Company has not granted loans or guarantees to any member of the Non- Executive members of the Board of Directors. No loans or guarantees to Non-Executive members of the Board of Directors were outstanding at December 31, 2023.
Executive members Board of Directors
Remuneration
The Executive Board Member is entitled to the following remuneration packages:
•Fixed remuneration: annual base salary;
•Variable remuneration: the variable remuneration components are (a) an annual bonus in cash as a percentage of the fixed component (short-term incentive) and (b) a (share- based) long-term incentive;
•Others: contribution pension premiums, travel allowance and holiday allowance.
Compensation was as follows and includes the entire year 2023, up to December 31, 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
Fixed remuneration |
|
Short-term variable: annual bonus |
|
Share-based payments |
|
Post-employment benefits |
|
Other |
|
Total |
| Dr Sijmen de Vries, CEO and Executive Director |
2023: |
673 |
|
|
2023: |
615 |
|
|
2023: |
1,371 |
|
|
2023: |
115 |
|
|
2023: |
35 |
|
|
2023: |
2,809 |
|
| 2022: |
636 |
|
|
2022: |
394 |
|
|
2022: |
1,221 |
|
|
2022: |
112 |
|
|
2022: |
34 |
|
|
2022: |
2,396 |
|
| 2021: |
681 |
|
|
2021: |
357 |
|
|
2021*: |
1,594 |
|
|
2021: |
120 |
|
|
2021: |
38 |
|
|
2021: |
2,790 |
|
* Due to a disclosure error in 2021 caused by the incorrect apportionment of the fair value share based payment expense over the vesting period, the restated 2021 share based payments remuneration disclosure of Dr. S. de Vries is $1.6 million compared to previously reported share based payments of $1.3 million.
Options
The following table gives an overview of movements in number of option holdings of the individual members of the executive board of directors in 2023, the exercise prices and expiration dates up to December 31, 2023 (note that the exercise price in US$ is translated using 2023 closing exchange rate (1:1.1002)):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January 1, 2023 |
|
Granted 2023 |
|
Exercised in 2023 |
|
Forfeited/Expired in 2023 |
|
December 31, 2023 |
|
Exercise price ($) |
|
Expiration date |
| Dr. Sijmen de Vries |
|
2,800,000 |
|
|
— |
|
|
— |
|
|
— |
|
|
2,800,000 |
|
|
0.886 |
|
|
May 22, 2024 |
Shares
At December 31, 2023, the executive members of the board held the following numbers of shares:
|
|
|
|
|
|
|
|
|
| Shares held |
|
As at December 31, 2023 |
| Dr. Sijmen de Vries |
|
8,141,383 |
|
Long term Incentive Plan
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year |
Granted |
Settled |
Forfeited |
Not vested |
Reserved as at December 31, 2023 |
| Dr. Sijmen de Vries |
|
2023 |
1,681,570 |
|
— |
|
— |
|
— |
|
1,681.570 |
|
|
|
2022 |
2,363,455 |
— |
|
— |
|
— |
|
2,363,455 |
|
|
2021 |
1,337,888 |
— |
|
— |
|
— |
|
1,337,888 |
Loans or guarantees
During the year 2023, no loans or guarantees have been granted to the Executive members of the Board of Directors. No loans or guarantees to the Executive member of the Board of Directors were outstanding at December 31, 2023.
The Executive member of the Board of Director is the sole statutory director.
22. RELATED PARTY TRANSACTIONS
Related parties’ disclosure relates mainly to key management compensation and to transactions with the associated company of BioConnection group (BioConnection).
Key management includes members of the Board of Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ‘000 |
2023 |
|
2022 |
2021 |
| Salaries and other short-term employee benefits |
1,756 |
|
|
1,463 |
|
1,522 |
|
| Post-employment benefits |
115 |
|
|
112 |
|
120 |
|
| Share-based compensation |
1,615 |
|
|
1,455 |
|
1,882 |
|
| Total |
3,486 |
|
|
3,030 |
|
3,524 |
|
All direct transactions with members of the Board of Directors have been disclosed in Notes 20. Share-based compensation and 21. Board of Directors of these financial statements.
For the years ended December 31, 2023, 2022 and 2021 related party transactions with Bioconnection were in the ordinary course of that company’s fill and finish business and amounted to $4.7 million, $3.0 million and $3.5 million respectively. At December 31, 2023 the Company owed $1.7 million to Bioconnection and was owed by Bioconnection $0.5 million for fill and finish services supplied. At December 31, 2022 BioConnection owed $0.5 million to the Company for fill and finish services supplied. At December 31, 2021 the Company owed $0.1 million to Bioconnection for fill and finish services supplied.
23. COMMITMENTS AND CONTINGENCIES
Material agreements
At the end of 2023, the Company had several agreements with third parties related to the manufacturing of RUCONEST® and Joenja® and development of new products. In these agreements certain minimum volumes are committed. Total future commitments under these agreements for the year ended December 31, 2023 and December 31, 2022 are approximately $58.3 million and $73.8 million, of which $21.9 million relates to 2024 and $36.4 million relates to 2025 and further.
Joenja® (leniolisib) milestone commitments
In August 2019, Pharming entered into a development collaboration and license agreement with Novartis to develop and commercialize leniolisib, a small molecule phosphoinositide 3-kinase delta (P13Kδ) inhibitor being developed by Novartis to treat patients with Activated Phosphoinositide 3-kinase Delta Syndrome (APDS). In November 2022, Pharming submitted regulatory filings to the FDA and EMA for the purpose to commercialize leniolisib. On March 24, 2023, Pharming received FDA approval for the commercialization of Joenja® (leniolisib) in the United States. We anticipate that the CHMP will issue its opinion on the leniolisib MAA in the first quarter of 2024 and expect European marketing authorisation approximately two months later.
Pharming has agreed upon phased Development and Regulatory Milestone payments of $20.5 million. As a result of the first commercial sale, Pharming has paid $10.4 million in Development and Regulatory Milestone payments in 2023. Furthermore, Pharming is committed to one-off Sales Milestone payments when annual net sales exceed set thresholds for the first time.
The total commitment equals $180.0 million when yearly net sales reach $500.0 million. The first milestone equals $5.0 million when yearly net sales reach $50.0 million. After a sales threshold has been reached for the first year, the milestone payment for that threshold does not recur. In 2023, the Company has not reached the first sales milestone of yearly net sales of $50.0 million and therefore did not make any sales milestone payment.
In addition to these milestone payments, the Company has agreed to pay royalty fees to Novartis. These royalties are calculated as a fixed percentage over net sales, growing to a maximum of 18% when net sales exceed $300.0 million. These royalty payments have a term of 10 years. The minimum royalty liability of 12% is applicable for sales up until $150.0 million. The timing of the milestone payments and royalty payments is uncertain as these are highly dependent on the enrollment of new patients for leniolisib. In 2023, the Company has made $2.1 million in royalty payments to Novartis.
24. FINANCIAL RISK MANAGEMENT
Pharming is exposed to several financial risks: market risks (being currency risk and interest rate risk), credit risks and liquidity risks. The Board of Directors and the Executive Committee are responsible for the management of currency, interest, credit and liquidity risks and as such ultimately responsible for decisions taken in this field.
Capital risk management
The Company manages its capital to ensure that it will be able to continue as a going concern. This includes a regular review of cash flow forecasts and, if deemed appropriate, subsequent raising of funds through execution of equity and/or debt transactions. In doing so, the Board of Directors’ and Executive Committees’ strategy is to achieve a capital structure which takes into account the best interests of all stakeholders. Pharming’s capital structure includes cash and cash equivalents, marketable securities, debt and equity. Compared to last year the Company has allocated a significant portion of the cash and cash equivalent position to euro denominated readily convertible S&P AAA- rated government treasury certificates with a maturity of six months or less, to capitalize on rising interest rates.
Currency risk
This is the risk that the fair value of assets, liabilities and especially the future cash flows of financial instruments will fluctuate because of changes in foreign exchange rates. Pharming’s policy for the management of foreign currency risks is aimed at protecting the operating profit and positions held or recorded in foreign currencies, in particular of the United States Dollar (USD) for the Group. Certain payments and sales in the United States are being and will be received in USD. In 2023, repayments and interest payments of the loans were made in USD. Some direct payments of U.S. activities are carried in USD through the Dutch entities. At December 31, 2023 the Group’s cash and cash equivalents, including restricted cash, and marketable securities amounted to $215.0 million. This balance consists of cash assets denominated in euros for a total amount of $172.2 million or €156.5 million (applying an exchange rate EUR/USD at December 31, 2023 of 1.1002 ) and cash assets in USD for a total amount of $42.7 million. The USD cash balance will mainly be used for the commercialization activities of the U.S. organization.
Cash and cash equivalents (including restricted cash), accounts receivables and inventories denominated in USD amounted in total $84.8 million (€77.1 million), respectively $33.7 million (€30.6 million) for the trade and other payables denominated in USD. Pharming performed a sensitivity analysis by applying an adjustment to the spot rate at year-end. As the balance of the cash and cash equivalents (including restricted cash), accounts receivables, inventories, trade and other payables, denominated in USD, at year-end is $51.1 million, a 10% strengthening or weakening of the euro versus U.S. dollar would have an impact of $5.1 million on the Group’s gain (weakening of the euro) or loss (strengthening of the euro).
Interest rate risk
Interest rate risk is the risk that the fair value of future cash flows of a financial instrument will fluctuate because of changes in market interest rates. Pharming’s interest rate risk policy is aimed at minimizing the interest rate risks associated with the financing of the Company and thus at the same time optimizing the net interest costs.
This policy translates into a certain desired profile of fixed-interest and floating interest positions, including those generated by cash and cash equivalents and marketable securities and those paid on finance lease liabilities. As the interest rate on the convertible bond is a fixed percentage, Pharming concluded that the total risk on interest is not material.
The issue of the Convertible Bonds due 2025 at a fixed interest rate of 3.00% p.a. replacing the Company’s previous debt facility has rendered this concern obsolescent. The interest on the vast majority of the Company’s financial instruments is now not variable with market interest rates. More information on the Convertible Bonds due 2025 can be found in Note 17. Convertible bonds.
Credit risk
Credit risk is defined as the risk that one party to a financial instrument will cause a financial loss for the other party by failing to discharge obligations. Pharming manages credit risk exposure through the selection of financial institutions having a high credit rating, using credit rating reports issued by institutions such as Standard & Poor’s and Moody’s. The exposure to credit risk at December 31, 2023 is represented by the carrying amounts of cash and cash equivalents, marketable securities and trade and other receivables.
The carrying amounts of the cash and cash equivalents (including restricted cash) as at December 31, 2023 amounted to $63.3 million and was held through financial institutions with a A- to A rating or better from Standard & Poor’s, A3 to Aa3 ratings from Moody’s and A to AA- ratings from Fitch.
Marketable securities at December 31, 2023 amounted to $151.7 million and was held in S&P AAA-rated government treasury certificates with a maturity of six months or less from the date of acquisition. We have considered the expected credit loss and recognized no losses, due to the AAA credit ratings.
Trade and other receivables at December 31, 2023 amounted to $46.2 million. As at the date of these financial statements, these amounts have largely been settled, including receipts in cash and receipt of goods and services in exchange of prepaid expense items. Based on the credit ratings of cash and cash equivalents (including restricted cash) as well as the positions taken with respect to marketable securities and trade and other receivables, the Company considers that this risk is adequately managed.
Liquidity risk
The liquidity risk refers to the risk that an entity will encounter difficulty in meeting obligations associated with financial liabilities. Pharming’s objective is to maintain a minimum level and certain ratio of cash and cash equivalents (including short-term deposits and readily convertible S&P AAA- rated government treasury certificates with a maturity of six months or less). The strategy of the Company is to repay its obligations through generation of cash income from operating activities such as product sales. In case such cash flows are insufficient, the Company relies on financing cash flows as provided through the issuance of shares or incurring financial liabilities. Note 2 of these financial statements more extensively describes the Company’s going concern assessment.
The following table presents the financial liabilities at year-end 2023, showing the remaining undiscounted contractual amounts due including nominal interest. Liabilities denominated in foreign currency have been converted at the exchange rate at December 31, 2023.
Maturity profile of financial liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in $ ’000 |
2024 |
|
2025 |
|
2026 |
|
2027 |
|
2028 and onwards |
|
Total |
|
Prior year total |
| Trade and other payables |
72,528 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
72,528 |
|
|
54,465 |
|
| Lease Liabilities |
5,071 |
|
|
4,548 |
|
|
4,143 |
|
|
3,729 |
|
|
22,600 |
|
|
40,091 |
|
|
40,691 |
|
| Convertible Bonds |
4,126 |
|
|
139,588 |
|
|
— |
|
|
— |
|
|
— |
|
|
143,714 |
|
|
143,338 |
|
| Total |
81,725 |
|
|
144,136 |
|
|
4,143 |
|
|
3,729 |
|
|
22,600 |
|
|
256,333 |
|
|
238,494 |
|
Fair value estimation
The Company uses the following hierarchy for determining the fair value of financial instruments measured at fair value:
•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 (that is, as prices) or indirectly (that is, derived from prices);
•Level 3: Inputs for the asset or liability that are not based on observable market data or which are based on the probability of future events occurring (that is, unobservable inputs).
The following table presents the assets that are measured at fair value at year-end 2023 and 2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
| Amounts in $ ’000 |
Level 1 |
|
Level 3 |
|
Total |
|
Level 1 |
|
Level 3 |
|
Total |
| Investments in equity instruments designated as at FVTOCI |
2,020 |
|
|
— |
|
|
2,020 |
|
|
403 |
|
|
— |
|
|
403 |
|
| Investments in debt instruments designated as at FVTPL |
— |
|
|
6,093 |
|
|
6,093 |
|
|
— |
|
|
6,827 |
|
|
6,827 |
|
| Balance at December 31 |
2,020 |
|
|
6,093 |
|
|
8,113 |
|
|
403 |
|
|
6,827 |
|
|
7,230 |
|
The following table includes carrying values and the estimated fair values of financial instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
| Amounts in $ ‘000 |
Carrying value |
|
Fair value |
|
Carrying value |
|
Fair value |
| Assets: |
|
|
|
|
|
|
|
| Cash and cash equivalents, including restricted cash |
63,269 |
|
|
63,269 |
|
|
208,654 |
|
|
208,654 |
|
| Marketable securities |
151,683 |
|
|
151,746 |
|
|
— |
|
|
— |
|
| Trade and other receivables |
46,158 |
|
|
46,158 |
|
|
27,619 |
|
|
27,619 |
|
| Liabilities: |
|
|
|
|
|
|
|
| Convertible Bond |
138,422 |
|
|
138,422 |
|
|
133,386 |
|
|
133,386 |
|
| Lease Liabilities |
33,123 |
|
|
33,123 |
|
|
33,308 |
|
|
33,308 |
|
| Trade and other payables |
72,528 |
|
|
72,528 |
|
|
54,465 |
|
|
54,465 |
|
The fair value of the Marketable securities is based on observable market information (level 1 valuation).
The above other fair values of financial instruments are based on internal calculations. Cash and cash equivalents, trade and other receivables as well as trade and other payables are stated at carrying amount, which approximates the fair value in view of the short maturity of these instruments. The fair values of finance lease liabilities and loans and borrowings (both non-current and current portion) are based on arm’s length transactions.
The following table sets out an analysis for each of the period presented of the net position of the convertible bond, cash and cash equivalents and marketable securities, showing the remaining undiscounted contractual amounts due including nominal interest.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in US$ ‘000 |
|
2023 |
|
2022 |
| Cash and cash equivalents |
|
61,741 |
|
|
207,342 |
|
| Restricted cash |
|
1,528 |
|
|
1,312 |
|
| Marketable securities |
|
151,683 |
|
|
— |
|
| Convertible bond - repayable within one year |
|
(1,824) |
|
|
(1,768) |
|
| Convertible bond - repayable after one year |
|
(136,598) |
|
|
(131,618) |
|
| Net cash (debt) |
|
76,530 |
|
|
75,268 |
|
|
|
|
|
|
| Cash and cash equivalents |
|
61,741 |
|
|
207,342 |
|
| Restricted cash |
|
1,528 |
|
|
1,312 |
|
| Marketable securities |
|
151,683 |
|
|
— |
|
| Gross debt - fixed interest rates |
|
(138,422) |
|
|
(133,386) |
|
| Gross debt - variable interest rates |
|
— |
|
|
— |
|
| Net cash (debt) |
|
76,530 |
|
|
75,268 |
|
Reconciliation of liabilities arising from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2022 |
|
Cashflows |
|
Non - Cash changes |
|
2023 |
| Amounts in US$’000 |
|
|
|
|
Acquisition and disposal |
|
Interest Expense Accrued |
|
Amortized costs |
|
Fair Value Changes |
|
Other |
|
|
| Convertible Bond |
133,386 |
|
|
(4,046) |
|
|
— |
|
|
4,046 |
|
|
830 |
|
|
— |
|
|
4,206 |
|
* |
138,422 |
|
| Lease Liabilities |
33,308 |
|
|
(5,126) |
|
|
1,295 |
|
|
1,193 |
|
|
— |
|
|
— |
|
|
2,453 |
|
|
33,123 |
|
| Total liabilities from financing activities |
166,694 |
|
|
(9,172) |
|
|
1,295 |
|
|
5,239 |
|
|
830 |
|
|
— |
|
|
6,659 |
|
|
171,545 |
|
* Represents the translation effect of convertible bonds as reflected in the consolidated statement of comprehensive income
25. EARNINGS PER SHARE AND FULLY-DILUTED SHARES
Basic earnings per share is calculated based on the weighted average number of ordinary shares outstanding during the year. Diluted earnings per share is normally computed based on the weighted average number of ordinary shares outstanding including the dilutive effect of shares to be issued in the future under certain arrangements such as option plans. However, as the net result represents a loss in 2023, the diluted earnings per share are equal to the basic earnings per share for 2023. For the years ended December 31, 2023, 2022 and 2021, the basic and diluted profit per share are:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2023 |
|
2022 |
|
2021 |
| Net profit (loss) attributable to equity owners of the parent (in US$’000) |
(10,548) |
|
|
13,674 |
|
|
15,996 |
|
| Weighted average shares outstanding |
657,020,521 |
|
|
648,676,119 |
|
|
642,007,692 |
|
| Basic profit (loss) per share (in US$) |
(0.016) |
|
|
0.021 |
|
|
0.025 |
|
| Weighted average diluted shares outstanding |
725,463,948 |
|
|
707,141,263 |
|
|
701,151,525 |
|
| Diluted profit (loss) per share (in US$) |
(0.016) |
|
|
0.019 |
|
|
0.023 |
|
For 2023 the diluted net profit used in the calculation of dilutive profit per share amounts to $10.5 million. Difference between the weighted average shares outstanding and the weighted average diluted shares outstanding used for basic profits calculations per share relates to options and LTIP. The 62,412,622 average shares related to the convertible bonds are anti-dilutive and are therefore excluded from the weighted average number of ordinary shares for the purpose of diluted earnings per share.
Diluted shares
The composition of the number of shares and share rights outstanding as well as authorized share capital as per December 31, 2023 and the date of these financial statements is provided in the following table.
Movements of shares and other instruments between December 31, 2023 and April 4, 2024 are shown in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2023 |
|
Shares issued |
|
Other |
|
4 April 2024 |
| Shares |
671,073,243 |
|
2,365,070 |
|
— |
|
673,438,313 |
| RSU |
11,187,064 |
|
— |
|
25,000 |
|
11,212,064 |
| Options |
34,482,312 |
|
(1,090,876) |
|
— |
|
33,391,436 |
| Convertible bonds |
62,412,622 |
|
— |
|
— |
|
62,412,622 |
| LTIP |
17,534,261 |
|
(1,222,839) |
|
5,365,914 |
|
21,677,336 |
| Issued |
796,689,502 |
|
51,355 |
|
5,390,914 |
|
802,131,771 |
| Available for issue |
259,310,498 |
|
(51,355) |
|
(5,390,914) |
|
253,868,229 |
| Authorized share capital |
1,056,000,000 |
|
— |
|
— |
|
1,056,000,000 |
26. SHAREHOLDERS’ EQUITY
The Company’s authorized share capital amounts to $11.6 million (€10.6 million), exchange rate (EUR:$) equals 1:1.1002) and is divided into 1,056,000,000 ordinary shares with a nominal value of €0.01 each. At December 31, 2023 and December 31, 2022, all 671,073,243 (€6.7 million) and 656,348,225 shares outstanding, have been fully paid-up.
Other reserves include those reserves related to currency translation, fair value revaluation, participating interest and capitalized development costs in which the movements can shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amounts in US$ ‘000 |
|
Legal Reserve Currency translation reserve (CTA) |
|
Legal Reserve Capitalized development cost |
|
Legal Reserve participating interest |
|
Reserve Fair value revaluation |
|
Total |
| Balance at January 1, 2022 |
|
3,965 |
|
402 |
|
1,316 |
|
(2,283) |
|
3,400 |
| Movements in the year |
|
(10,349) |
|
— |
|
(1,083) |
|
(705) |
|
(12,137) |
| Balance at December 31, 2022 |
|
(6,384) |
|
402 |
|
233 |
|
(2,988) |
|
(8,737) |
| Movements in the year |
|
6,042 |
|
(296) |
|
(233) |
|
1,167 |
|
6,680 |
| Balance at December 31, 2023 |
|
(343) |
|
106 |
|
— |
|
(1,821) |
|
(2,057) |
Please refer to the consolidated statement of changes in equity and Note 25.
27. EVENTS AFTER THE REPORTING YEAR
Management identified no events after the reporting period affecting the 2023 financial statements.
EX-1
2
pharming-exhibit11_04apr24.htm
EX-1.1 AMENDED AND RESTATED ARTICLES OF ASSOCIATION OF PHARMING GROUP N.V
Document
Exhibit 1.1
CONTINUOUS TEXT of the articles of association of Pharming Group N.V., with corporate seat in Leiden, after partial amendment to the articles of association, by deed executed before P.C.S. van der Bijl, civil law notary in Amsterdam, on 23 May 2023.
Trade Registry number 28048592.
This is a translation into English of the original Dutch text. An attempt has been made to be as literal as possible without jeopardizing the overall continuity. Inevitably, differences may occur in
translation, and if so the Dutch text will by law govern.
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ARTICLES OF ASSOCIATION
DEFINITIONS
Article 1
In these articles of association the following words shall have the following meanings:
a."accountant":
a chartered accountant ("registeraccountant") or other accountant referred to in Section 2:393 of the Dutch Civil Code or an organisation in which such accountants work together;
b."dependent company":
a dependent company as referred to in Section 2:152 of the Dutch Civil Code;
c."general meeting":
a meeting of shareholders and other persons entitled to attend meetings of shareholders or the body of the company formed by such shareholders and other persons, as the case may be;
d."board regulations":
the internal regulations applicable to the board of directors, as drawn up by the board of directors;
e."directors report":
the directors report as referred to in Section 2:391 of the Dutch Civil Code;
f."central institute":
a central institute ("centraal instituut") within the meaning of the GSTA;
g."participant":
a participant in a collective depot ("verzameldepot");
h."subsidiary":
i."indemnified officer":
a subsidiary of the company within the meaning of Section 2:24a of the Dutch Civil Code; a current or former director (including, for the avoidance of doubt the former members of the company's board of management and board of supervisory directors prior to the amendment to these articles of association on the eleventh day of December two thousand and twenty) or such other current or former officer or employee of the company or its subsidiaries, acting (or, for former officers or employees, having acted) in the capacity as manager or supervisor, as designated by the board of directors from time to time;
j."girodepot":
a girodepot within the meaning of the GSTA;
k."group company":
a group company as referred to in Section 2:24b of the Dutch Civil Code;
l."intermediary":
an intermediary ("intermediair") within the meaning of the GSTA;
m."annual accounts":
the balance and profit and loss statement with explanatory notes;
n."in writing":
except as otherwise required by law, by letter, by telecopier or e-mail or by any other legible and reproducible electronically sent message provided that the identity of the sender can be sufficiently established;
o."distributable equity":
the part of the company's equity which exceeds the aggregate of the paid in and called up part of the capital and the reserves which must be maintained pursuant to the law;
p."company body":
the board of directors or the general meeting;
q."global share certificate":
the share certificate that embodies all ordinary bearer shares;
r."collective depot":
a collective depot ("verzameldepot") within the meaning of the Dutch Giro Securities Transactions Act;
s."GSTA":
the Dutch Giro Securities Transactions Act ("Wet giraal effectenverkeer").
NAME AND SEAT
Article 2
1.1 The name of the company is:
Pharming Group N.V.
1.2The company has its official seat in Leiden.
OBJECTS
Article 3
The objects of the company are:
a.to engage, in any way whatsoever, in the development, research, production, commercialization, marketing and distribution of pharmaceutical products, including but not limited to innovative products for rare diseases and unmet medical needs;
b. to incorporate, to participate in, to manage and to take part financially in any way whatsoever, in other companies and enterprises;
c.to render services to other companies, persons and enterprises in the medical, administrative, technical, financial, economical and managerial fields;
d.to develop and trade in patents, trade marks, licenses, intellectual and other industrial property rights;
e.to obtain, alienate, manage and exploit registered property, securities, and items of property in general;
f.to borrow or to lend funds, as well as to act as guarantor or as severally-liable co-debtor, or to bind itself as security for a debt of a third party,
and furthermore to do everything that is connected therewith or may be conducive thereto, all this to be interpreted in the widest sense of the word.
SHARES - AUTHORISED SHARE CAPITAL
Article 4
1.1The company's authorised capital amounts to ten million five hundred and sixty thousand euro (EUR 10,560,000).
1.2The authorised capital is divided into one billion fifty-six million (1,056,000,000) ordinary shares of one eurocent (EUR 0.01) each.
1.3 The ordinary shares shall be bearer shares or registered shares as described hereafter such to be determined by the shareholder. No share certificates shall be issued for registered shares.
SHARES - GLOBAL SHARE CERTIFICATE
Article 5
1.1Upon its request a subscriber for ordinary shares shall, at issuance thereof, receive ordinary registered shares; if such explicit request has not been made, the subscriber shall receive ordinary bearer shares as described hereunder.
1.2All ordinary bearer shares are embodied in one global share certificate.
1.3The global share certificate is meant to be kept by a central institute in accordance with the GSTA.
1.4Shares can only be transferred out of the girodepot or a collective depot in accordance with the relevant provisions of the GSTA.
1.5In the event that a holder of one or more ordinary registered shares wishes to convert his ordinary registered shares into ordinary bearer shares, (a) the ordinary registered shares involved shall be transferred to a central institute and this transfer shall be served upon or acknowledged by the company (b) the company shall remove the name of the person entitled thereto as holder of ordinary registered shares from its shareholders' register, (c) the applicable central institute shall add or have the ordinary registered shares involved added to the global share certificate, by which the number of ordinary bearer shares embodied in the global share certificate shall be increased with the number of ordinary bearer shares thus added, (d) the applicable central institute shall credit each intermediary designated by the person entitled thereto for a share in the girodepot of ordinary bearer shares corresponding with the number of shares added to the global share certificate and (e) the intermediary shall credit the person entitled thereto accordingly in its collective depot of ordinary bearer shares.
1.6For the application of the provisions in these articles of association a participant in a collective depot shall also be regarded as holder of ordinary bearer shares.
1.7The global share certificate shall be signed by or on behalf of an executive director; such signing may take place by means of facsimile.
SHARES - REGISTERS OF SHAREHOLDERS
Article 6
1.1The board of directors shall keep a register for ordinary registered shares. In the register the names and addresses of all holders of ordinary registered shares are recorded.
1.2Each holder of ordinary registered shares and each person holding a right of usufruct or a pledge on such shares is obliged to notify the company in writing of his address.
1.3In the register shall be recorded the date on which the ordinary registered shares are acquired by the shareholder, the date of acknowledgement by or serving upon the company and the amount paid on each share.
1.4In the event that registered shares form part of a collective depot or a girodepot, the shareholders' register may include the name and the address of the intermediary respectively the applicable central institute, the date on which subject shares commenced to form part of the collective depot respectively girodepot, the date of acknowledgement or the date of serving upon the company, as well as the amount paid on each share.
1.5All entries and recordings in the register shall be signed by or on behalf of an executive director.
1.6Extracts from the register shall be non-transferable.
1.7The register shall also be subject to the provisions of Section 2:85 of the Dutch Civil Code.
SHARES - ISSUE
Article 7
1.1Shares shall be issued pursuant to a resolution of the general meeting or another company body designated for that purpose by the general meeting for a period of maximum five years.
1.2Designation of the company body competent to issue shares may be extended by the articles of association or by a resolution of the general meeting for a period not exceeding five years in each case. The number of shares, which may be issued, shall be determined at the time of this designation. Designation by resolution of the general meeting cannot be revoked unless determined otherwise at the time of designation.
1.3Upon termination of the authority of the company body designated by the general meeting, the issue of shares shall thenceforth require a resolution of the general meeting, unless another company body has been designated by the general meeting.
1.4A resolution of the general meeting to issue shares or to designate another company body as the company body competent to issue shares, may only be adopted at the proposal of the board of directors.
1.5The provisions of Article 7.1 through 7.4 shall equally apply to the granting of rights to subscribe for shares but shall not be applicable to the issue of shares to persons exercising a previously granted right to subscribe for shares.
1.6Moreover, the provisions of Section 2:96 of the Dutch Civil Code shall be applicable to the issue of shares and the granting of rights to subscribe for shares.
SHARES – TERMS OF ISSUE AND PRE-EMPTIVE RIGHTS
Article 8
1.1The price and other terms of issue shall be determined by the resolution to issue shares. Except as provided in Section 2:80 paragraph 2 of the Dutch Civil Code, the issue price shall not be lower than par.
1.2Each holder of ordinary shares shall have a pre-emptive right to any issue of ordinary shares, in accordance with the provisions stated below. The same shall apply to the granting of rights to subscribe for ordinary shares.
1.3The pre-emptive right may be restricted or excluded by a resolution of the general meeting or by the company body that has been designated pursuant to Article 7.1 to limit or exclude the pre-emptive right for a period of maximum five years. Article 7.1 through Article 7.4 shall equally apply.
1.4If less than one half of the issued capital is represented at the general meeting, a majority of at least two-thirds of the votes cast shall be required for a resolution of the general meeting to restrict or exclude the pre-emptive right or to make the designation referred to in Article 8.3. Within eight days after the resolution the company shall file the full text thereof at the Commercial Register.
1.5Moreover, Section 2:97 of the Dutch Civil Code shall apply to the terms of the issue and pre-emptive rights.
SHARES - PAYMENT
Article 9
1.1On subscription for each ordinary share payment thereon shall be made of the full amount of the par value and, if the share is subscribed for at a higher amount, of the difference between such amounts.
1.2Persons who are professionally engaged in the placing of shares for their own account may be permitted, by agreement, to pay less than the nominal amount for the shares subscribed by them, provided that not less than ninety-four percent (94%) of such amount is paid in cash, at the latest on subscription for the shares.
1.3Payment on ordinary shares shall be made in cash, unless another contribution has been agreed on.
1.4Payment in foreign currency may only be made with the company's approval.
1.5The board of directors shall be authorised, without the prior approval of the general meeting, to perform legal acts relating to non-cash contributions on ordinary shares and the other legal acts referred to in Section 2:94 of the Dutch Civil Code.
SHARES - ACQUISITION OF OWN SHARES
Article 10
1.1The company may acquire fully paid up shares in its own capital, but only for no consideration or if:
a.the distributable equity is at least equal to the purchase price; and
b.the nominal value of the shares in its capital or depository receipts thereof which the company acquires, holds or holds on lien or which are held by a subsidiary does not exceed one tenth of the issued capital.
1.2The board of directors shall require the authorisation of the general meeting for an acquisition for valuable consideration. This authorisation shall be valid for a maximum period of eighteen months. The general meeting shall determine in the authorisation how many shares may be acquired, how they may be acquired and between what limits the price must lie.
1.3The company may acquire shares in its own capital in order to transfer these, pursuant to a regulation in force for them, to employees of the company or of a group company.
1.4Shares in the company's own capital shall be acquired or disposed of pursuant to a resolution of the board of directors, without prejudice to the provisions in Article 10.2.
1.5The company may co-operate to the issue of depository receipts for shares.
1.6In calculating the amount of any distribution on the shares, the shares held by the company in its own capital, shall not be taken into account.
SHARES - REDUCTION OF ISSUED SHARE CAPITAL
Article 11
1.1The general meeting may, but only at the proposal of the board of directors, resolve to reduce the issued capital:
a.by cancelling shares; or
b.by reducing the amount of the shares by an amendment to the articles of association.
A resolution of the general meeting to reduce the issued capital shall designate the shares to which the resolution relates and provide for the implementation of the resolution.
1.2A resolution to cancel may only concern shares held by the company in its own capital.
1.3Any reduction of the nominal amount of shares without repayment and without a release of the obligation to pay up, must be made pro rata to all the shares. Such pro rata requirement may be waived if all shareholders concerned so agree.
1.4Partial repayment on shares or release from the obligation to pay up shall only be permitted in furtherance of a resolution to reduce the amount of the shares. Such a repayment or release must be made in respect of all shares. Any partial repayment on shares or release from the obligation to pay up shall be made pro rata to all shares concerned.
1.5Moreover, the provisions of Sections 2:99 and 2:100 of the Dutch Civil Code shall apply to the reduction of capital.
SHARES - ISSUE AND TRANSFER REQUIREMENTS, USUFRUCT AND PLEDGE
Article 12
1.1A transfer of a registered ordinary share or of a right of usufruct or pledge thereon shall require a deed of transfer and, except in the event the company itself is party to that legal act, acknowledgement in writing by the company of the transfer. The acknowledgement shall be given in the deed, or by a dated statement embodying such acknowledgement on the deed, or on a copy or extract thereof duly authenticated by a civil law notary or by the transferor. Service of such deed, copy or extract upon the company shall be deemed to be equal to acknowledgement. In any other event, a transfer of a registered ordinary share or of a right of usufruct or pledge thereon shall be effected in accordance with Sections 2:86, 2:86a and 2:86b of the Dutch Civil Code, subject to Sections 10:137 through 10:141 of the Dutch Civil Code.
1.2A pledge may also be established on a share without acknowledgement by or service upon the company. In such cases, Section 3:239 of the Dutch Civil Code shall equally apply, whereby the notification of pledge by a shareholder as referred to in paragraph 3 of that Section, shall be replaced by acknowledgement by or service upon the company. In all other events a pledge shall be established in accordance with Sections 2:86, 2:86a and 2:86b of the Dutch Civil Code, subject to Sections 10:137 through 10:141 of the Dutch Civil Code.
1.3The provisions of Articles 12.1 and 12.2 shall equally apply to the allotment of shares by distribution of any community.
1.4Upon the establishment of a usufruct or a pledge on a share, the holder of the usufruct or pledge shall have the voting rights attached thereto if this was provided when the usufruct or pledge was created. Usufructuaries and pledgees without voting rights shall not have the rights conferred by law upon the holders of depository receipts issued with the company's cooperation.
1.5In deviation of the other stipulations of this Article 12:
a.the transfer of ordinary registered or bearer shares in a collective depot or a girodepot, or the creation of a right of usufruct or pledge thereon, shall take place in the manner as stipulated in the GSTA; and
b.for as long as any ordinary shares and/or American Depository Shares or American Depository Receipts for such ordinary shares are admitted to trading on the New York Stock Exchange, the NASDAQ Stock Market or on any other regulated stock exchange operating in the United States of America, the board of directors may decide that the laws of the State of New York shall apply to the property law aspects of the ordinary shares which are either reflected in the register administered by the relevant transfer agent or held by a depository or custodian for purposes of issuing the American Depository Shares or American Depository Receipts concerned, without prejudice to the applicable provisions of Chapters 4 and 5 of Title 10 of Book 10 of the Dutch Civil Code.
BOARD OF DIRECTORS - COMPOSITION
Article 13
1.1The company has a board of directors consisting of:
a.one or more executive directors, being primarily charged with the day-to-day operations of the company; and
b.one or more non-executive directors, being primarily charged with the supervision of the performance of the duties of the directors.
The board of directors shall be composed of individuals.
1.2The board of directors shall determine the number of executive directors and the number of non-executive directors.
1.3In the event two or more executive directors are in office, the board of directors may attribute titles to the individual executive directors, including those of "Chief Executive Officer", "Chief Financial Officer", "Chief Medical Officer" and/or "Chief Operating Officer". In the event one executive director is in office, that executive director shall carry the title of "Chief Executive Officer".
1.4The board of directors shall elect a non-executive director to be the chairperson. The board of directors may dismiss the chairperson, provided that the chairperson so dismissed shall subsequently continue his or her term of office as a non-executive director without having the title of chairperson.
1.5If a director is absent or incapacitated, such director may be replaced temporarily by a person whom the board of directors has designated for that purpose and, until then, the other directors shall be charged with the management of the company. If all directors are absent or incapacitated, the management of the company shall be attributed to one or more persons whom the general meeting has designated for that purpose. The person(s) charged with the management of the company in this manner, may designate one or more persons to be charged with the management of the company instead of, or together with, such person(s).
1.6A director shall be considered to be unable to act within the meaning of Article 13.5:
a.during the existence of a vacancy on the board of directors, including as a result of:
i.such director's death;
ii.such director's dismissal by the general meeting, other than at the proposal of the board of directors;
iii.voluntary resignation before such director's term of office has expired; or
iv.not being reappointed by the general meeting, notwithstanding a (binding) nomination to that effect by the board of directors,
provided that the board of directors may always decide to decrease the number of directors such that a vacancy no longer exists;
b.during such director's suspension;
c.in a period during which the company has not been able to contact such director (including as a result of illness), provided that such period lasted longer than five consecutive days (or such other period as determined by the board of directors on the basis of the facts and circumstances at hand); or
d.in connection with and during the deliberations and decision-making of the board of directors on (i) matters in relation to which such director has declared to have, or in relation to which the board of directors has established that such director has, a conflict of interests as described in the first two sentences of Article 17.7 and/or (ii) transactions with a related party in which such director is involved within the meaning of the last sentence of Article 17.7.
BOARD OF DIRECTORS - APPOINTMENT, SUSPENSION AND DISMISSAL
Article 14
1.1Directors shall be appointed or reappointed by the general meeting. Upon the appointment of a person as a director, the general meeting shall determine whether that person is appointed as executive director or as non-executive director.
1.2At a general meeting, a resolution to appoint a director can only be passed in respect of candidates whose names are stated for that purpose in the agenda of that general meeting or the explanatory notes thereto.
1.3The appointment shall take place from a list of candidates to be drawn up by the board of directors. A nomination shall be binding.
1.4The general meeting may reject a nomination with a simple majority of the votes cast representing at least one third of the issued capital. If the nomination is rejected by simple majority of the votes cast, but such majority does not represent at least one third of the issued capital, a new meeting may be convened in which the nomination may be rejected with a simple majority of the votes cast. In that event, the board of directors shall draw up a new nomination.
1.5Each director may be suspended or dismissed by the general meeting at any time by a resolution adopted with a simple majority of the votes cast, representing at least one third of the issued capital. If the majority of the votes cast are in favour of the proposal to suspend or dismiss a director, but such majority does not represent at least one third of the issued capital, a new meeting may be convened in which the director concerned may be suspended or dismissed with a simple majority of the votes cast.
1.6An executive director may also be suspended by the board of directors. A suspension by the board of directors may be terminated at any time by the general meeting. Any suspension may be extended one or more times, but may not last longer than three months in the aggregate.
BOARD OF DIRECTORS – COMPENSATION
Article 15
1.1The general meeting shall adopt the remuneration policy in respect of remuneration of the board of directors.
1.2The remuneration for directors shall be adopted by the board of directors taking into account the policy referred to in Article 15.1, provided that arrangements in the form of shares or rights to subscribe for shares are subject to the approval of the general meeting. The request for approval shall at least state the number of shares or rights to subscribe for shares that may be granted to the directors and which criteria apply to the granting or amendment thereof.
1.3The absence of approval of the general meeting shall not affect the authority of the board of directors pursuant to Article 15.2.
BOARD OF DIRECTORS - DUTIES AND ORGANISATION
Article 16
1.1Subject to the restrictions imposed by these articles of association, the board of directors shall be entrusted with the management of the company. In performing their duties, directors shall be guided by the interests of the company and of the business connected with it.
1.2The board of directors shall draw up board regulations regarding its organisation, decision-making and other internal matters, with due observance of these articles of association. In performing their duties, the directors shall act in compliance with the board regulations.
1.3The directors may allocate their duties amongst themselves in or pursuant to the board regulations or otherwise pursuant to resolutions adopted by the board of directors, provided that:
a.the executive directors shall be charged with the day-to-day operations of the company;
b.the task of supervising the performance of the duties of the directors cannot be taken away from the non-executive directors;
c.the chairperson must be a non-executive director; and
d.the making of proposals for the appointment of a director and the determination of the compensation of the executive directors cannot be allocated to an executive director.
1.4The board of directors may determine in writing, in or pursuant to the board regulations or otherwise pursuant to resolutions adopted by the board of directors, that one or more directors can validly pass resolutions in respect of matters which fall under his/her/their duties.
1.5The board of directors shall establish the committees which the company is required to have and otherwise such committees as are deemed to be appropriate by the board of directors. The board of directors shall draw up (and/or include in the board regulations) regulations concerning the organisation, decision-making and other internal matters of its committees.
BOARD OF DIRECTORS - DECISION-MAKING
Article 17
1.1Each director may cast one vote in the decision-making of the board of directors.
1.2A director can be represented by another director holding a written proxy for the purpose of the deliberations and the decision-making of the board of directors.
1.3Resolutions of the board of directors shall be passed, irrespective of whether this occurs at a meeting or otherwise, by a simple majority of the votes cast unless the board regulations provide differently.
1.4Invalid votes, blank votes and abstentions shall not be counted as votes cast. Directors who casted an invalid or blank vote or who abstained from voting shall be taken into account when determining the number of directors who are present or represented at a meeting of the board of directors.
1.5Where there is a tie in any vote of the board of directors, the chairperson shall have a casting vote, provided that there are at least three directors in office. Otherwise, the relevant resolution shall not have been passed.
1.6The executive directors shall not participate in the decision-making concerning:
a.the determination of the compensation of executive directors; and
b.the instruction of an auditor to audit the annual accounts if the general meeting has not granted such instruction.
1.7A director does not participate in the deliberations and decision-making of the board of directors on a matter in relation to which such director has a direct or indirect personal interest therein that is contrary to the interests of the company and the enterprises connected therewith. If, as a result, no board resolution can be passed, the resolution may nevertheless be passed by the board of directors as if none of the directors has a conflict of interests as described in the previous sentence. The foregoing provisions of this Article 17.7 apply equally with respect to the decision-making of the board of directors if a director is involved in a transaction with a related party as defined by Section 2:167 paragraph 2 of the Dutch Civil Code.
1.8Meetings of the board of directors can be held through audio-communication facilities, unless a director objects thereto.
1.9Resolutions of the board of directors may, instead of at a meeting, be passed in writing, provided that all directors are familiar with the resolution to be passed and none of them objects to this decision-making process. Articles 17.1 through 17.8 apply equally.
1.10The approval of the general meeting is required for resolutions of the board of directors concerning a material change to the identity or the character of the company or the business, including in any event:
a.transferring the business or materially all of the business to a third party;
b.entering into or terminating a long-lasting alliance of the company or of a subsidiary either with another entity or company, or as a fully liable partner of a limited partnership or general partnership, if this alliance or termination is of significant importance for the company; and
c.acquiring or disposing of an interest in the capital of a company by the company or by a subsidiary with a value of at least one third of the value of the assets, according to the balance sheet with explanatory notes or, if the company prepares a consolidated balance sheet, according to the consolidated balance sheet with explanatory notes in the company's most recently adopted annual accounts.
1.11The absence of the approval of the general meeting of a resolution as referred to in Article 17.10 shall result in the relevant resolution being null and void pursuant to Section 2:14 paragraph 1 of the Dutch Civil Code but shall not affect the powers of representation of the board of directors or of the directors.
BOARD OF DIRECTORS - REPRESENTATION
Article 18
1.1The board of directors shall be authorised to represent the company. The power to represent the company also vests in the Chief Executive Officer acting individually.
1.2The board of directors may appoint staff members with general or limited power to represent the company. Each appointment may be revoked at any time. Each of these staff members shall represent the company with due observance of the restrictions of the authorization. The board of directors shall determine their titles.
INDEMNITY
Article 19
1.1The company shall indemnify and hold harmless each of its indemnified officers against:
a.any financial losses or damages incurred by such indemnified officer; and
b.any expense reasonably paid or incurred by such indemnified officer in connection with any threatened, pending or completed suit, claim, action or legal proceedings of a civil, criminal, administrative or other nature, formal or informal, in which such indemnified officer becomes involved,
to the extent this relates to his current or former position with the company and/or a group company and in each case to the extent permitted by applicable law.
1.2No indemnification shall be given to an indemnified officer:
a.if a competent court or arbitral tribunal has established, without having (or no longer having) the possibility for appeal, that the acts or omissions of such indemnified officer that led to the financial losses, damages, expenses, suit, claim, action or legal proceedings as described in Article 19.1 are of an unlawful nature (including acts or omissions which are considered to constitute malice, gross negligence, intentional recklessness and/or serious culpability attributable to such indemnified officer);
b.to the extent that his financial losses, damages and expenses are covered under insurance and the relevant insurer has settled, or has provided reimbursement for, these financial losses, damages and expenses (or has irrevocably undertaken to do so);
c.in relation to proceedings brought by such indemnified officer against the company, except for proceedings brought to enforce indemnification to which such indemnified officer is entitled pursuant to these articles of association, pursuant to an agreement between such indemnified officer and the company which has been approved by the board of directors or pursuant to insurance taken out by the company for the benefit of such indemnified officer; or
d.for any financial losses, damages or expenses incurred in connection with a settlement of any proceedings effected without the company's prior consent.
1.3 The board of directors may stipulate additional terms, conditions and restrictions in relation to the indemnification referred to in Article 19.1.
REPORTING - FINANCIAL YEAR, ANNUAL ACCOUNTS AND DIRECTOR REPORT
Article 20
1.1The financial year of the company shall be the calendar year.
1.2Annually, within the term set in respect thereto by or pursuant to the law, the board of directors shall draw up annual accounts (consisting of the balance, the profit and loss account with explanatory notes and the consolidated accounts). The annual accounts shall be signed by all directors. If the signature of one or more of them is lacking, this shall be stated and reasons given. The board of directors shall draw up a directors report within the aforementioned period of time.
1.3The general meeting shall appoint an accountant in order to audit the annual accounts as drawn up by the board of directors, and, if drawn up, the directors report, and to produce a report on his audit examinations to the board of directors. If the general meeting fails to do so, the appointment shall be made by the board of directors. The accountant as mentioned in this Article 20.3 may be questioned by the general meeting about his statement on the fairness of the annual accounts.
1.4The company shall ensure that the annual accounts and the directors report, as well as the information to be added by virtue of Section 2:392 paragraph 1 of the Dutch Civil Code, are held at its office as from the day on which the general meeting at which the annual accounts are dealt with, is convened for inspection by those entitled to attend the meeting, who can obtain a copy thereof, free of charge.
1.5The general meeting shall adopt the annual accounts.
1.6A discharge from any liability for the directors with respect to the conduct of their duties as director of the company, shall only relate to activities, insofar as such activities are reflected in the annual accounts or otherwise known to the general meeting.
1.7The company is obliged to make its annual accounts publicly available at the Trade Register with due observance of the relevant legal provisions to this effect.
DISTRIBUTIONS – DIVIDEND AND RESERVATIONS
Article 21
1.1The board of directors shall annually determine the amount of the distributable profit - the surplus on the profit and loss account - to be reserved.
1.2The part of the profit remaining after the reservation in accordance with Article 21.1 shall be at the disposal of the general meeting for distribution as dividend on the ordinary shares at the proposal of the board of directors.
1.3The general meeting may resolve on a proposal of the board and directors to make payments to the holders of the ordinary shares out of the distributable equity.
1.4The general meeting may resolve on a proposal of the board of directors that a dividend payment on ordinary shares shall in whole or in part not be made in cash, but in shares in the company.
1.5The board of directors may resolve to distribute an interim dividend, subject to the requirements of applicable law.
1.6Moreover, Sections 2:103, 2:104, and 2:105 of the Dutch Civil Code and Article 10.6 shall apply to distributions to shareholders.
1.7Dividends and other distributions shall be payable ultimately fourteen days after the resolution to make the distribution. The date of payment shall be announced in accordance with Article 24.
1.8The parties entitled to a dividend or other distribution shall be the relevant shareholders, usufructuaries and pledgees, as the case may be, at a record date to be determined by the board of directors for that purpose. This date shall not be earlier than the date on which the dividend or distribution was announced.
1.9The board of directors may resolve to charge amounts to be paid up on ordinary shares against the Company's reserves, irrespective of whether those ordinary shares are issued to existing shareholders.
GENERAL MEETING - CONVENING AND HOLDING MEETINGS
Article 22
1.1 The annual general meeting shall be held every year within six months after the end of the financial year. The following topics shall be on the agenda for such meeting:
a. the discussion of the directors report;
b.the adoption of the annual accounts;
c.the advisory vote on the company's remuneration report;
d.discharge of the directors;
e.appointments or re-appointment of directors, as applicable;
f.the appointment of an auditor in order to audit the annual accounts;
g.any other proposals put forward by the board of directors, and announced in accordance with Article 24, for example the designation of the board of directors to issue shares and the authorisation of the board of directors to cause the company to acquire shares in its own capital or depository receipts thereof.
1.2Extraordinary general meetings shall be held as often as the board of directors deems such necessary, or upon the written request addressed to the board of directors by those entitled to attend meetings, representing at least one tenth of the issued capital, which request sets out in detail the subjects to be discussed.
1.3If shareholders representing at least one tenth of the issued capital, pursuant to the stipulations of Article 22.2 have requested the board of directors to convene a general meeting, but the board of directors has not taken the necessary measures so that the meeting can be held within eight weeks after receipt of the request, the requesting parties shall be authorised to convene such meeting themselves.
1.4Shareholders who alone, or in the aggregate, represent at least three per cent (3%) of the company's issued capital, or any other threshold from time to time applicable pursuant to the Dutch Civil Code, have the right to request the board of directors to place items on the agenda of a general meeting.
1.5General meetings shall be held in Leiden, Amsterdam, Rotterdam, The Hague, Haarlemmermeer, Leiderdorp or Oegstgeest.
1.6Without prejudice to the provisions in Article 22.3, the convocation of general meetings of registered shares shall be made by the board of directors in accordance with Article 24.
1.7The convocation notice shall state the subjects of the meeting. Announcements which pursuant to the law or these articles of association, must be addressed to the general meeting, may be included either in the convocation notice or deposited at the offices of the company for inspection, provided that the convocation notice mentions such deposit. The convocation notice shall furthermore state the requirement mentioned in Article 23.2.
1.8Without prejudice to the stipulations of the second sentence of Section 2:111 paragraph 1 of the Dutch Civil Code, the convocation shall take place not later than on the forty-second day prior to the date of the meeting.
1.9The general meetings shall be presided over by one of the following individuals, taking into account the following order or priority:
a.by the chairperson of the board of directors, if there is a chairperson and the chairperson is present at the meeting;
b.by the Chief Executive Officer, if there is a Chief Executive Officer and the Chief Executive Officer is present at the meeting;
c.by one of the directors designated thereto by the directors present at the meeting;
d.by another person appointed by the general meeting.
1.10The chairperson of the general meeting shall appoint another person present at the general meeting to act as secretary and to minute the proceedings at the general meeting. The minutes of a general meeting shall be adopted by the chairperson of that general meeting or by the board of directors. Where an official report of the proceedings is drawn up by a civil law notary, no minutes need to be prepared. Every director may instruct a civil law notary to draw up such an official report at the company's expense.
1.11The board of directors shall record the resolutions adopted. The records shall be deposited at the offices of the company for inspection by persons entitled to attend meetings. Upon request, subject persons shall be provided with a copy or an extract of these records at actual cost.
GENERAL MEETING - EXERCISE OF MEETING AND VOTING RIGHTS
Article 23
1.1For each general meeting, the registration date as referred to in Section 2:119 of the Dutch Civil Code will be set on the twenty-eighth day prior to the date of the meeting, to determine who shall be entitled to vote at and/or attend the general meeting.
1.2In the general meeting, rights may only be exercised, if the persons entitled to attend the meeting have announced to the board of directors in writing at least seven (7) days prior to the meeting (or such shorter period prior to the meeting as allowed by the board of directors in view of special circumstances), that they intend to attend the meeting personally, or that they shall be represented by proxy.
1.3Those entitled to attend meetings shall be authorised to attend to address the general meetings, either in person or by proxy authorised in writing.
1.4The accountant as mentioned in Article 20.3 shall be invited by the board of directors to attend the general meeting and shall be authorized to address that meeting.
1.5In order to take part in the voting, those entitled to vote respectively their representatives must sign the attendance book, indicating the number of shares represented by them.
1.6Each share confers the right to cast one vote.
1.7No votes may be cast with respect to shares in the capital of the company held by the company or a subsidiary; nor with respect to shares for which any of them holds depository receipts, subject to Section 2:118 paragraph 7 of the Dutch Civil Code.
1.8To determine the number of shareholders voting, present or represented, shares for which the law determines that no vote can be cast shall be disregarded.
1.9Resolutions of the general meeting shall be adopted by a simple majority of the votes cast, provided the law does not require a larger majority.
1.10Subject to any provision of mandatory Dutch law, if and for as long as the Company is subject to the rules and requirements of the New York Stock Exchange, the NASDAQ Stock Market or on any other regulated stock exchange operating in the United States of America and such securities exchange requires the company to have a quorum for the general meeting, then the general meeting can only pass resolutions if at least one third of the issued and outstanding shares in the company's capital (being the part of the issued share capital of the company that is not held by the company itself) is represented at such general meeting; in that case, a second meeting as referred to in Section 2:120 paragraph 3 of the Dutch Civil Code cannot be convened.
1.11Invalid votes, blank votes and abstentions shall not be counted as votes cast. Ordinary shares in respect of which an invalid or blank vote has been cast and ordinary shares in respect of which an abstention has been made shall be taken into account when determining the part of the issued share capital that is represented at a general meeting.
1.12Voting on matters of business shall take place by acclamation, unless the chairperson of the general meeting decides otherwise.
1.13In the event of a tie of votes on matters of business, the proposal is rejected.
1.14As long as the entire issued capital is represented at a general meeting valid resolutions can be adopted, even if the formalities for the convocation and holding of meetings have not been complied with, provided such resolutions are adopted unanimously.
GENERAL MEETING – CONVOCATIONS AND NOTIFICATIONS
Article 24
All convocation notices for general meetings, all announcements relating to dividends and other distributions and all other communications to shareholders shall made in accordance with the relevant provisions thereon of applicable law.
AMENDMENT TO THE ARTICLES OF ASSOCIATION AND DISSOLUTION
Article 25
1.1A resolution of the general meeting to amend the articles of association or to dissolve the company may only be adopted on a proposal of the board of directors.
1.2If a proposal to amend the articles to association or to dissolve the company is put to the general meeting, this shall at all times be stated in the convocation notice of the general meeting and, in the event of an amendment of the articles of association, a copy of the proposal including the verbatim text of the proposed amendment shall be deposited simultaneously at the office of the company for inspection and made available free of charge to shareholders and others with meeting rights until the end of the meeting.
LIQUIDATION
Article 26
1.1In the event of dissolution of the company pursuant to a resolution of the general meeting, the board of directors shall be charged with the liquidation of the business of the company.
1.2During liquidation, the provisions of these articles of association shall remain in force to the extent possible.
1.3The balance remaining after settlement of debts, shall be transferred to the holders of ordinary shares, in proportion to the aggregate amount of their shareholdings.
1.4The liquidation shall furthermore be subject to the provisions of Title 1, Book 2 of the Dutch Civil Code.
THE UNDERSIGNED
P.C.S. van der Bijl, civil law notary in Amsterdam, hereby declares that he is satisfied that, to the best of his knowledge, the articles of association of Pharming Group N.V., with corporate seat in Leiden, immediately after execution of the abovementioned deed of amendment to the articles of association, read as per the text printed above.
Signed at Amsterdam, on 24 May 2023.
(Signed: P.C.S. van der Bijl)
EX-1
3
pharming-exhibit12_04apr.htm
EX-1.2 BOARD RULES OF PHARMING GROUP N.V.
pharming-exhibit12_04apr
Pharming Group N.V. | Board Rules Page 1/11 Exhibit 1.2 Board Rules of Pharming Group N.V. 1 April 2024 Pharming Group N.V. | Board Rules Page 2/11 Exhibit 1.2 INTRODUCTION Article 1. Introduction 1.1 These Board Rules govern the organization, decision-making and other internal matters of the Board. In performing their duties, the Directors shall comply with these Board Rules. 1.2 These Board Rules have been approved by the Board in its meeting of 20 March 2024 and are effective of 1 April 2024. 1.3 These Board Rules shall be posted on the Company’s website. Article 2. Definitions and Interpretation 2.1 In these Board Rules the following definitions shall apply: - Articles of Association: the Company's articles of association; - Board: the Company's board of directors; - Board Rules: the internal rules governing the role and responsibility of the Board as outlined in this document; - Board Meeting: a meeting of the Board; - CEO: the Company's chief executive officer; - Chairperson: the chairperson of the Board; - Committee: the Company’s audit committee, remuneration committee, corporate governance committee, transaction committee, and such other committee as the Board may establish from time to time to the exclusion of the Executive Committee and the Company’s disclosure committee; - Committee Charter: the charter of the relevant Committee or the Executive Committee; - Company: Pharming Group N.V.; - Company Secretary: the Company's company secretary; - Conflict of Interests: direct or indirect personal interest which conflicts with the interests of the Company and of the business connected with it; - Director: a member of the Board; - Executive Committee: the Company's executive committee; - Executive Director: an executive Director; - External Auditor: the auditor or audit firm within the meaning of Section 2:393 of the Dutch Civil Code, engaged to audit the Company's annual accounts and annual report, or the Company's independent outside audit firm for purposes of U.S. laws and regulations (including applicable NASDAQ and/or SEC requirements), as the context may require; - Family Member: a Director's spouse, registered partner or other life companion, foster child or any relative or in-law up to the second degree; - General Meeting: the Company's general meeting; - NASDAQ: the NASDAQ Stock Market; - Non-Executive Director: a non-executive Director; - Profile: the Company's profile for the size, composition, and independence of the group of Non-Executive Directors; - SEC: the U.S. Securities and Exchange Commission; - Simple Majority: more than half of the votes cast; and - Vice-Chairperson: the vice-chairperson of the Board. Pharming Group N.V. | Board Rules Page 3/11 Exhibit 1.2 2.2 References to statutory provisions are to those provisions as they are in force from time to time. 2.3 Terms that are defined in the singular have a corresponding meaning in the plural. 2.4 Except as otherwise required by law, the terms "written" and "in writing" include the use of electronic means of communication. CHAPTER I. BOARD RULES Article 3. Composition 3.1 The Board consists of up to three Executive Directors and up to seven Non-Executive Directors. 3.2 The size, composition and independence of the Board shall be determined taking into consideration the provisions of the Company’s diversity & inclusion policy and the Profile. 3.3 The Directors shall be appointed, suspended, and dismissed in accordance with the Articles of Association and applicable law. 3.4 A person may be appointed as Executive Director for a term of up to four years, without limitation on the number of consecutive terms which an Executive Director may serve. A person may be appointed as Non-Executive Director for a maximum of two consecutive terms of up to four years each and, subsequently, for a maximum of two consecutive terms of up to two years each. 3.5 In the event two or more Executive Directors are in office, the Board may attribute titles to the individual Executive Directors, including (but not limited to) those of "Chief Executive Officer", "Chief Financial Officer" and "Chief Medical Officer". In the event one Executive Director is in office, that Executive Director shall carry the title of "Chief Executive Officer". 3.6 The Board shall elect a Non-Executive Director to be the Chairperson and another Non- Executive Director to be the Vice-Chairperson. The Board may dismiss the Chairperson or the Vice-Chairperson, provided that the Non-Executive Director so dismissed shall subsequently continue their term of office as a Non-Executive Director without having the title of Chairperson or Vice-Chairperson, as the case may be. 3.7 The Chairperson shall not be a former member of the Executive Committee and shall be independent within the meaning of best practice provision 2.1.8 of the Dutch Corporate Governance Code. 3.8 A Director shall retire in the event of inadequate performance, structural incompatibility of interests, and in other instances where early retirement of the Director is considered necessary by the Board. 3.9 The Board shall ensure that: a. the Company has a sound plan in place for the succession of Directors which is aimed at retaining the appropriate balance in the requisite expertise, experience, and diversity on the Board; and b. a retirement schedule is prepared to avoid, as much as possible and practicable, Non-Executive Directors retiring simultaneously. 3.10 The acceptance by an Executive Director of a position as supervisory director or non- Pharming Group N.V. | Board Rules Page 4/11 Exhibit 1.2 executive director with another company or entity shall be subject to the approval of the Board. An Executive Director shall notify the Board in advance of any other position the Executive Director wishes to pursue. Article 4. Duties and Organization 4.1 The Board is charged with the management of the Company, subject to the restrictions contained in the Articles of Association, with the Executive Directors being primarily charged with the Company's day-to-day operations and the Non-Executive Directors being primarily charged with the supervision of the performance of the duties of the Directors. See Annex 1 for the "Allocation and delegation of powers and duties by the Board to the Executive Director(s)”. 4.2 In performing its duties, the Board: a. is guided by the interests of the Company and the business connected with it, thereby carefully considering, and balancing the interests of all stakeholders of the Company and the environment in which the Company operates; b. fosters and maintains a culture focused on sustainable long-term value creation by the Company, financial and non-financial risk awareness, adherence to the Company’s risk appetite, and responsible and ethical behavior within the Company; c. encourages behavior that is in keeping with the Company’s values and propagate these values through leading by example; and d. ensures good communication with its external and internal stakeholders, considering the interests of stakeholders. 4.3 The Board may obtain information from officers and external advisers of the Company to perform their duties, and the Company shall facilitate this. 4.4 All Directors shall follow an induction program geared to their role, covering general financial, social, and legal affairs, financial and sustainable reporting by the Company, specific aspects that are unique to the Company and its business, the Company's corporate culture, the Company's relationship with employees and the responsibilities of a Director under applicable law. 4.5 The Executive Directors shall ensure that internal procedures are established and maintained which safeguard that relevant information is or becomes known to the Board in a timely fashion. 4.6 At least annually, the Board shall evaluate - outside the presence of the Executive Directors - the functioning of the Board, the Committees, and the functioning of the individual Directors, shall discuss the conclusions of such evaluations, and shall identify aspects where the Directors require further training or education. Each Non-Executive Director may require that all Non-Executive Directors be able to express their views confidentially during such evaluation. The evaluation will take place periodically under the supervision of an external expert. When performing the annual evaluation, the Non-Executive Directors shall at least consider: a. substantive aspects; b. conduct and culture; c. the mutual interaction and collaboration among the Board;
Pharming Group N.V. | Board Rules Page 5/11 Exhibit 1.2 d. lessons learned from recent events; and e. the desired profile, composition, competency, and expertise of the Board. Article 5. Chairperson, Vice-Chairperson and Company Secretary 5.1 The Chairperson, in regular consultation with the CEO, shall ensure that: a. the Non-Executive Directors have proper contact with the Executive Directors, the Executive Committee, the Company's employee representatives (if any) and the General Meeting; b. the Board elects a Vice-Chairperson; c. there is sufficient time for deliberation and decision-making by the Board; d. the Directors receive all information that is necessary for the proper performance of their duties in a timely fashion; e. the Board, the Executive Committee and the Committees have a balanced composition and function properly; f. the functioning of individual Directors is reviewed at least annually; g. the Directors follow their induction program, as well as their education or training program; h. the Executive Directors perform activities to create a culture aimed at sustainable long-term value creation for the Company; i. the Board is responsive to signs of misconduct or irregularities from the Company's business and ensures that any material misconduct and irregularities, or suspicions thereof, are reported to the Board without delay; j. the General Meeting proceeds in an orderly and efficient manner; k. effective communication with the Company's investors is assured; and l. the Non-Executive Directors shall be involved closely, and at an early stage, in any merger or takeover process involving the Company. 5.2 If the Chairperson is absent or incapacitated, the Chairperson may be replaced temporarily by the Vice-Chairperson. 5.3 The Chairperson shall act on behalf of the Board as the primary contact for Directors and investors regarding the functioning of Directors, except for the Chairperson himself or herself. The Vice-Chairperson shall fulfil such role regarding the functioning of the Chairperson. 5.4 The Board is supported by a Company Secretary. The Company Secretary shall be appointed and dismissed by the Board. Article 6. Decision-making 6.1 The Board shall meet as often as any Director deems necessary or appropriate. 6.2 Directors are expected to attend Board Meetings and the meetings of the Committees of which they are members. If a Director is frequently absent at such meetings, the Director shall be held accountable by the Board. 6.3 A Board Meeting may be convened by, or at the request of, any Director by means of a written notice sent to all Directors. Notice of a Board Meeting shall include the date, time, place, and agenda for that Board Meeting. Board Meetings can be held through audio- Pharming Group N.V. | Board Rules Page 6/11 Exhibit 1.2 communication facilities. 6.4 All Directors shall be given reasonable notice of at least five days for all Board Meetings unless a shorter notice is required to avoid a delay which could reasonably be expected to have an adverse effect on the Company and/or the business connected with it. 6.5 If a Board Meeting has not been duly convened, resolutions may nevertheless be passed at that Board Meeting if all Directors not present or represented at that Board Meeting have waived compliance with the convening formalities in writing. 6.6 All Board Meetings shall be chaired by the Chairperson or, in their absence, by the Vice- Chairperson or, in their absence, by another Director designated by the Directors present at the relevant Board Meeting. The chairperson of the Board Meeting shall appoint a secretary to prepare the minutes of the proceedings at such Board Meeting. 6.7 Minutes of the proceedings at a Board Meeting shall be sufficient evidence thereof and of the observance (or waiver) of all necessary formalities, provided that such minutes are approved in the next Board Meeting, provided that the chairperson of the relevant Board Meeting may certify the minutes before they have been approved in the next Board Meeting in case such minutes are needed on an urgent basis. 6.8 Each Director may cast one vote in the decision-making of the Board. Invalid votes, blank votes and abstentions shall not be counted as votes cast. 6.9 A Director can be represented by another Director holding a written proxy for the purpose of the deliberations and the decision-making of the Board. 6.10 Resolutions of the Board shall be passed, irrespective of whether this occurs at a Board Meeting or otherwise, by Simple Majority, unless these Board Rules provide differently. 6.11 Where there is a tie in any vote of the Board, the relevant resolution shall not have been passed. 6.12 Resolutions of the Board may, instead of at a Board Meeting, be passed in writing, provided that all Directors are familiar with the resolution to be passed and none of them objects to this decision-making process. Articles 6.8 through 6.11 apply mutatis mutandis. 6.13 Each Director, group of Directors, or Committee can validly pass resolutions in respect of matters which fall under the tasks and duties allocated to such Director, group of Directors, or Committee, respectively, pursuant to these Board Rules or a Committee Charter. 6.14 The Board may require that officers and external advisers of the Company attend Board Meetings. In particular, the Board shall request the External Auditor to attend the Board Meeting where the External Auditor's audit report regarding the Company's financial statements is discussed. Article 7. Conflict of Interest 7.1 A Director shall promptly report any actual or potential Conflict of Interests in a transaction that is of material significance to the Company and/or such Director to the other Directors, providing all relevant information relating to such transaction, including the involvement of any Family Member. 7.2 The determination whether a Director has a Conflict of Interests shall primarily be the responsibility of that Director. However, in case of debate, that determination shall be made by the Board without the Director concerned being present. Pharming Group N.V. | Board Rules Page 7/11 Exhibit 1.2 7.3 A Director shall not participate in the deliberations and decision-making of the Board on a matter in relation to which the Director has a Conflict of Interests. If, as a result thereof, no resolution can be passed by the Board, the resolution may nevertheless be passed by the Board as if none of the Directors has a Conflict of Interests. 7.4 Transactions in respect of which a Director has a Conflict of Interests shall be agreed on arms' length terms. Any such transactions where the Conflict of Interests is of material significance to the Company and/or to the Director concerned shall be subject to the approval of the Board. 7.5 To avoid potential Conflicts of Interests, or the appearance thereof, Directors shall not: a. enter into competition with the Company; b. demand or accept substantial gifts from the Company for themselves or for their respective Family Members; c. provide unjustified advantages to third parties to the detriment of the Company; d. take advantage of business opportunities to which the Company would be entitled for themselves or for their respective Family Members. 7.6 The Company shall not grant its Directors or their respective Family Members any personal loans, guarantees or similar financial arrangements. 7.7 This Article 7 applies without prejudice to the Board Rules under the Company's related person transaction policy concerning decision-making with respect to related person transactions in which a Director is involved. Article 8. Ownership of and Trading in Financial Instruments 8.1 The Directors shall be subject to the Company's insider trading policy. In addition, each Director shall practice great reticence: a. when trading in shares or other financial instruments issued by another listed company, if this could reasonably create the appearance of such Director violating applicable insider trading and/or market manipulation prohibitions; and b. when trading in shares or other financial instruments issued by another listed company which is a direct competitor of the Company. 8.2 This Article 8 applies without prejudice to the Company's code of conduct and its insider trading policy. Article 9. Executive Committee 9.1 The Executive Committee supports the CEO in performing their tasks and shall be subject to this Article 9 and its Committee Charter. 9.2 Unless the Committee Charter provides differently, Article 6 of the Board Rules applies mutatis mutandis to the decision-making of the Executive Committee, provided that references to the Chairperson should be interpreted as being references to the chairperson of the Executive Committee and no Vice-Chairperson shall be appointed for the Executive Committee. 9.3 The Board shall regularly review and discuss the reports received from the Executive Committee. Pharming Group N.V. | Board Rules Page 8/11 Exhibit 1.2 Article 10. Committees 10.1 Each Committee shall be subject to this Article 10 and its respective Committee Charter. 10.2 Unless the relevant Committee Charter provides differently, Article 6 of the Board Rules applies mutatis mutandis to the decision-making of each Committee, provided that references to the Chairperson should be interpreted as being references to the chairperson of the relevant Committee and no Vice-Chairperson shall be appointed for a Committee. 10.3 The Board shall regularly review and discuss the reports received from the respective Committees. CHAPTER II. OTHER PROVISIONS Article 11. Amendments and Deviations 11.1 Pursuant to a resolution to that effect, the Board may amend or supplement these Board Rules and allow temporary deviations from these Board Rules, subject to ongoing compliance with applicable law and stock exchange requirements. 11.2 The Board shall review and re-assess these Board Rules every two years or earlier if required due to regulatory changes and/or business developments. Article 12. Governing law and Jurisdiction These Board Rules shall be governed by and shall be construed in accordance with the laws of the Netherlands. Any dispute arising in connection with these Board Rules shall be submitted to the exclusive jurisdiction of the competent court in Amsterdam, the Netherlands.
Pharming Group N.V. | Board Rules Page 9/11 Exhibit 1.2 ANNEX 1 ALLOCATION AND DELEGATION OF POWERS AND DUTIES BY THE BOARD TO THE EXECUTIVE DIRECTOR(S) 1. Introduction 1.1. This Annex forms an integral part of the Board Rules, and therefore the same definitions are used as included in article 2 of the Board Rules. 1.2. Article 16.4 of the Company’s Articles of Association authorizes the Board to determine in writing, in or pursuant to the Board Rules or otherwise pursuant to resolutions adopted by the Board, that one or more members of the Directors can validly pass resolutions in respect of matters which fall under their duties. 1.3. The Articles of Association and the Board Rules also provide that the Executive Director(s) shall be primarily charged with the Company’s day-to-day operations. 1.4. This Annex 1 “Allocation and delegation of powers and duties by the Board to the Executive Director(s)” aims to give clear guidance on the tasks and duties and the decision-making powers as allocated and delegated to the Executive Director(s), supported by the Executive Committee, in accordance with Article 16.4 of the Articles of Association and the Board Rules. 1.5. This Annex supplements the Board Rules, without prejudice to the Board Rules and regulations as set forth therein and each time subject to the provisions of the Articles of Association. 2. Delegation 2.1. The Board allocates to the Executive Director(s) all its tasks and duties, and delegates to the Executive Director(s) all decision-making powers, regarding the following matters, subject to the provisions set forth in the Articles of Association and the Board Rules: i. management of the day-to-day business and operations of the Company and its subsidiaries in accordance with Company’s mission, vision, and core values; ii. execution of the sustainable long-term strategy of the Company as approved by the Board; iii. setting, and updating, if necessary, commercial strategies, budgets, standards and values and performance targets both (i) at business and department level and (ii) for the Company’s subsidiaries, in accordance with the approved strategy, budget, corporate standards and values and targets at Company level; iv. execution of the Company's risk management and internal controls regarding the business and operations of the Company and its subsidiaries and the effective functioning of the internal control framework; v. execution and monitoring of the Company’s environmental, social & governance program as approved by the Board; vi. nominations, appointments, dismissals, appraisals, performance management and succession planning for the members of the Executive Committee, excluding the Executive Director(s) (all appointments and dismissals of the members of the Executive Committee subject to approval by the Board, upon recommendation of the Corporate Governance Committee), and for the heads of divisions and other Pharming Group N.V. | Board Rules Page 10/11 Exhibit 1.2 senior executives of the Company and its subsidiaries; vii. execution of the Company’s remuneration policy and other benefits policies and incentive programs, as approved by the Board (to the extent required), for all staff members of the Company and its subsidiaries, excluding the CEO and the other members of the Executive Committee; viii. determining, or changing, the managerial structure of the business and the respective departments of the Company and its subsidiaries; ix. financial contributions, grants, or other sponsorships to or for third parties within the approved budget and in accordance with internal policies; transactions, expenditures, or investments up to an amount of five million euro/USD (EUR/USD 5,000,000) per transaction or a series of related transactions, except for Related Person Transactions as discussed in Article 2.2 below; x. initiating, changing, or terminating drug development programs, clinical trials, other programs or projects and partnerships, in furtherance of the strategy and the business and operations of the Company and its subsidiaries, unless of far- reaching significance to the Company or requiring an investment in excess of the threshold as identified sub ix.; xi. formulating, updating, and issuing policies with respect to the internal organization of and the business connected with the Company and its subsidiaries; xii. contacts with shareholders, investors, industry organizations, institutions and other external networks and stakeholders in the ordinary course of business, subject to the rules and processes stipulated by the prevailing policy; xiii. management of the Company’s intellectual property portfolio; xiv. decisions on the disclosure of inside information, or the delay of disclosure to the extent permitted, in accordance with the applicable laws and regulations, subject to the post notification of the Board as soon as reasonably practical; xv. engagement of consultants or other third-party advisors for any of the tasks and duties as allocated hereinabove. 2.2. Without prejudice to the provisions set forth in the Articles of Association and the Board Rules, and subject to applicable law and stock exchange requirements, at least the following matters shall require a decision, or an approval, of the full Board: i. adoption of, or amendments to, the Company’s strategy; ii. approval of, or amendments to, the Company’s annual budget and (financial and non-financial) objectives and targets; iii. approval of, or amendments to, the Company’s corporate standards, culture, and values; iv. transactions, expenditures, or investments that will either cause an overrun of the approved annual budget, or that exceed the amount of five million euro (EUR/USD 5,000,000) per transaction or a series of related transactions; v. participation by the Company or a subsidiary in the capital of another company, as well as a significant increase or decrease of such participation; vi. entering into or terminating a long-term co-operation by the Company with another legal entity or company, if that co-operation or termination of co- Pharming Group N.V. | Board Rules Page 11/11 Exhibit 1.2 operation is of major significance to the Company; vii. acquisitions, disposals, the entering into of financing arrangements (whether as lender, borrower, guarantor or obligor), the creation of security rights, the granting of suretyships, joint liabilities, indemnities and guarantees; viii. approval of the Company’s internal control framework and any changes thereto; ix. entering into, amending or terminating any Related Person Transaction as defined in the Company’s Related Person Policy; x. approval of procedures established for reporting of actual or suspected misconduct or irregularities, or any changes thereto; xi. approval of the Company's code of conduct, or any changes thereto (whether or not such deviations are of a temporary or continuous nature); xii. execution of the Company’s remuneration policy and other benefits policies and incentive program, for the members of the Executive Committee. xiii. the termination of the employment of a considerable number of the Company's, or a subsidiary's, employees simultaneously or within a short period of time; xiv. a significant change in the employment conditions of a substantial number of the Company's, or a subsidiary’s, employees.
EX-2
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pharming-exhibit21_04apr24.htm
EX-2.1 DESCRIPTION OF SECURITIES
Document
Exhibit 2.1
DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED
PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934
The following description sets forth certain material terms and provisions of the securities of Pharming Group N.V. (“Pharming,” the “company” “we,” “us,” and “our’) that are registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This description also summarizes relevant provisions of our articles of association, Dutch law and relevant provisions of the Dutch Corporate Governance Code (“DCGC”). The following summary does not purport to be complete and is subject to, and is qualified in its entirety by reference to, the applicable provisions of Dutch law, DCGC and our articles of association, a copy of which is filed as an exhibit to the Annual Report on 20-F of which this Exhibit is apart. We encourage you to read our articles of association and the applicable provisions of Dutch law and the DCGC for additional information.
GENERAL
Our securities include (a) our ordinary shares, nominal value €0.01 per share, and (b) our American Depositary Shares (the “ADSs”), each representing ten ordinary shares, nominal value €0.01 per share.
Our ordinary shares are registered under the Exchange Act not for trading, but only in connection with the listing of the ADSs on The Nasdaq Global Market. Our ordinary shares are currently traded on Euronext Amsterdam under the ticker symbol “PHARM”.
Our ADSs are listed on The Nasdaq Global Market under the trading symbol “PHAR”.
The following is a description of the rights of (i) the holders of ordinary shares and (ii) ADS holders. Ordinary shares underlying the outstanding ADSs are held by JPMorgan Chase Bank, N.A., as depositary (“JPMorgan” or the “Bank”).
ORDINARY SHARES
In accordance with our articles of association, the following summarizes the rights of holders of our ordinary shares:
•each holder of ordinary shares is entitled to one vote per share on all matters to be voted on by shareholders generally, including the appointment and reappointment of directors;
•there are no cumulative voting rights;
•the holders of our ordinary shares are entitled to dividends and other distributions as may be declared from time to time by us in accordance with our articles of association and applicable law;
•upon our liquidation and dissolution, the holders of ordinary shares will be entitled to share ratably in the distribution of all of our assets remaining available for distribution after satisfaction of all our liabilities; and
•the holders of ordinary shares have preemptive rights in case of share issuances or the grant of rights to subscribe for shares, except if such rights are limited or excluded by the corporate body authorized to do so and except in such limited cases as provided by Dutch law and our articles of association.
Type and Class of Securities
Each ordinary share has a nominal value of €0.01.
Form of Shares
Under our articles of association, our ordinary shares may be issued either in registered form (aandelen op naam) or in bearer form (aandelen aan toonder). Ordinary shares in bearer form must be embodied in a global certificate kept in custody by a central institute within the meaning of the Dutch Giro Securities Transfer Act (Wet giraal effectenverkeer) for purposes of facilitating book-entry transfers of the ordinary shares embodied by such global certificate.
Share Register
The company is responsible for keeping a shareholders’ register, in which only the holders of shares in registered form will be registered. The board of directors keeps our shareholders’ register and records names and addresses of all holders of shares in registered form, showing the date on which the shares were acquired, the date of the acknowledgement by or notification of us as well as the amount paid on each share. The register also includes the names and addresses of those with a right of use and enjoyment (vruchtgebruik) in shares belonging to another or a pledge (pandrecht) in respect of such shares in registered form.
Preemptive Rights
Under Dutch law, in the event of an issuance of ordinary shares, each shareholder will have a pro rata preemptive right in proportion to the aggregate nominal value of the ordinary shares held by such holder (with the exception of ordinary shares to be issued to employees or ordinary shares issued against a contribution other than in cash or pursuant to the exercise of a previously acquired right to subscribe for shares). Under our articles of association, the preemptive rights in respect of newly issued ordinary shares may be restricted or excluded by a resolution of the general meeting. Another corporate body, such as the board of directors, may restrict or exclude the preemptive rights in respect of newly issued ordinary shares if it has been designated as the authorized body to do so by the general meeting. Such designation can be granted for a period not exceeding five years. A resolution of the general meeting to restrict or exclude the preemptive rights or to designate another corporate body as the authorized body to do so requires a majority of not less than two-thirds of the votes cast, if less than one-half of our issued share capital is represented at the meeting. As at May 17, 2023, our board of directors has been authorized, for a period of eighteen months starting on May 17, 2023 to issue shares, grant rights to acquire shares and to limit or exclude preemptive rights in relation to an issuance of shares up to 10% of the issued share capital (as per May 17, 2023).
Limitation on Liability and Indemnification Matters
Under Dutch law, our directors may be held liable for damages in the event of improper or negligent performance of their duties. They may be held jointly and severally liable for damages to the company and to third parties for infringement of the articles of association or of certain provisions of Dutch law. In certain circumstances, they may also incur additional specific civil and criminal liabilities. Subject to certain exceptions, our articles of association provide for indemnification of our current and former directors (and other current and former officers and employees as designated by our board of directors). No indemnification shall be given to an indemnified person:
(a)if a competent court or arbitral tribunal has established, without having (or no longer having) the possibility for appeal, that the acts or omissions of such indemnified person that led to the financial losses, damages, expenses, suit, claim, action or legal proceedings as described above are of an unlawful nature (including acts or omissions which are considered to constitute malice, gross negligence, intentional recklessness and/or serious culpability attributable to such indemnified person);
(b)to the extent that their financial losses, damages and expenses are covered under insurance and the relevant insurer has settled, or has provided reimbursement for, these financial losses, damages and expenses (or has irrevocably undertaken to do so);
(c)in relation to proceedings brought by such indemnified person against the company, except for proceedings brought to enforce indemnification to which he is entitled pursuant to our articles of association, pursuant to an agreement between such indemnified person and the company which has been approved by the board of directors or pursuant to insurance taken out by the company for the benefit of such indemnified person; or
(d)for any financial losses, damages or expenses incurred in connection with a settlement of any proceedings effected without the company’s prior consent.
Under our articles of association, our board of directors may stipulate additional terms, conditions and restrictions in relation to the indemnification described above.
Shareholder Meetings
General meetings may be held in Leiden, Amsterdam, Rotterdam, The Hague, Haarlemmermeer, Leiderdorp or Oegstgeest, the Netherlands. The annual general meeting must be held within six months after the end of each financial year. Additional extraordinary general meetings may also be held, whenever considered appropriate by the board of directors and shall be held within three months after our board of directors has considered it to be likely that our equity has decreased to an amount equal to or lower than half of its paid up and called up share capital, in order to discuss the measures to be taken if so required.
Pursuant to Dutch law, one or more shareholders or others with meeting rights under Dutch law who jointly represent at least one-tenth of the issued share capital may request us to convene a general meeting, setting out in detail the matters to be discussed. If our board of directors has not taken the steps necessary to ensure that such meeting can be held within eight weeks after the request, the proponent(s) may, on their application, be authorized by the competent Dutch court in preliminary relief proceedings to convene a general meeting. The court shall disallow the application if it does not appear that the proponent(s) has/have previously requested our board of directors to convene a general meeting and our board of directors has not taken the necessary steps so that the general meeting could be held within eight weeks after the request. The application shall also be disallowed if the proponent(s) has/have not demonstrated to have a reasonable interest in the convening of the general meeting.
General meetings can be convened by a notice, which shall include an agenda stating the items to be discussed, including for the annual general meeting, among other things, the adoption of the annual accounts, an advisory vote on our remuneration report, the discharge from liability for our directors, the appointment of our external auditor for purposes of Dutch law, appropriation of our profits and proposals relating to the composition of the board of directors, including the filling of any vacancies in the board of directors. In addition, the agenda shall include such items as have been included therein by the board of directors. The agenda shall also include such items requested by one or more shareholders, or others with meeting rights under Dutch law, representing at least 3% of the issued share capital.
Requests must be made in writing (or by electronic means of communication) and received by the board of directors at least 60 days before the day of the meeting. No resolutions shall be adopted on items other than those that have been included in the agenda.
A shareholder exercising its right to put an item on the agenda must notify the company, in its request, of the following information (in case the right is exercised by multiple shareholders, the information listed below may be aggregated):
(a)the percentage of the issued share capital represented by the ordinary shares which are, or are deemed to be (under the applicable Dutch attribution rules), at the disposal of such shareholder; and
(b)the percentage of the issued share capital represented by the financial instruments which are at the disposal of such shareholder and which constitute a short position with respect to ordinary shares.
In accordance with the DCGC, a shareholder shall exercise the right of putting an item on the agenda or to request convening of a general meeting only after consulting the board of directors in that respect. If exercising such rights may result in a change in the company’s strategy (for example, the removal of directors), the board of directors must be given the opportunity to invoke a reasonable period to respond to such intention. Such period shall not exceed 180 days. If invoked, the board of directors must use such response period for further deliberation and constructive consultation, in any event with the shareholder(s) concerned and shall explore the alternatives. At the end of the response time, the board of directors shall report on this consultation and the exploration of alternatives to the general meeting. The response period may be invoked only once for any given general meeting and shall not apply: (a) in respect of a matter for which a response period or a statutory cooling-off period (as discussed below) has been previously invoked; or (b) if a shareholder holds at least 75% of the company’s issued share capital as a consequence of a successful public bid.
Moreover, our board of directors can invoke a cooling-off period of up to 250 days when shareholders, using their right to have items added to the agenda for a general meeting or their right to request a general meeting, propose an agenda item for our general meeting to dismiss, suspend or appoint one or more directors (or to amend any provision in our articles of association dealing with those matters) or when a public offer for our company is made or announced without our support, provided, in each case, that our board of directors believes that such proposal or offer materially conflicts with the interests of our company and its business. During a cooling-off period, our general meeting cannot dismiss, suspend or appoint directors (or amend the provisions in our articles of association dealing with those matters) except at the proposal of our board of directors. During a cooling-off period, our board of directors must gather all relevant information necessary for a careful decision-making process and at least consult with shareholders representing 3% or more of our issued share capital at the time the cooling-off period was invoked, as well as with our Dutch works council (if we or, under certain circumstances, any of our subsidiaries would have one). Formal statements expressed by these stakeholders during such consultations must be published on our website to the extent these stakeholders have approved that publication. Ultimately one week following the last day of the cooling-off period, our board of directors must publish a report in respect of its policy and conduct of affairs during the cooling-off period on our website. This report must remain available for inspection by shareholders and others with meeting rights under Dutch law at our office and must be tabled for discussion at the next general meeting. Shareholders representing at least 3% of our issued share capital may request the Enterprise Chamber for early termination of the cooling-off period. The Enterprise Chamber must rule in favor of the request if the shareholders can demonstrate that:
•our board of directors, in light of the circumstances at hand when the cooling-off period was invoked, could not reasonably have concluded that the relevant proposal or hostile offer constituted a material conflict with the interests of our company and its business;
•our board of directors cannot reasonably believe that a continuation of the cooling-off period would contribute to careful policy-making; or
•other defensive measures, having the same purpose, nature and scope as the cooling-off period, have been activated during the cooling-off period and have not since been terminated or suspended within a reasonable period at the relevant shareholders’ request (i.e., no ‘stacking’ of defensive measures).
The general meeting is presided over by the chairperson of the board of directors. If no chairperson has been elected or if the chairperson is not present at the meeting, the general meeting shall be presided over by the chief executive officer. If no chief executive officer has been elected or if the chief executive officer is not present at the meeting, the general meeting shall be presided over by another director present at the meeting. If no director is present at the meeting, the general meeting shall be presided over by any other person appointed by the general meeting. In each case, the person who should chair the general meeting pursuant to the rules described above may appoint another person to chair the general meeting instead. Directors may always attend a general meeting. In these meetings, they have an advisory vote. The chairperson of the meeting may decide at their discretion to admit other persons to the meeting.
All shareholders and others with meeting rights under Dutch law are authorized to attend the general meeting, to address the meeting and, in so far as they have such right, to vote. Shareholders may exercise these rights, if they are the holders of shares on the record date, if any, as required by Dutch law, which is currently the 28th day before the day of the general meeting. Under our articles of association, rights may only be exercised, if the persons entitled to attend the meeting have announced to the board of directors in writing at least seven (7) days prior to the meeting (or such shorter period prior to the meeting as allowed by the board of directors in view of special circumstances), that they intend to attend the meeting personally, or that they shall be represented by proxy.
Each share confers the right on the holder to cast one vote at the general meeting. Shareholders may vote by proxy. As a matter of Dutch law, the board of directors must allow and facilitate that shareholders and others with voting rights can provide a proxy to the company by electronic means of communication (e.g., via e-mail). In addition, the company must make a proxy form available to shareholders and others with voting rights when convening a general meeting. No votes may be cast at a general meeting on shares held by us or our subsidiaries or on shares for which we or our subsidiaries hold depository receipts. Nonetheless, the holders of a right of use and enjoyment (vruchtgebruik) and the holders of a right of pledge (pandrecht) in respect of shares held by us or our subsidiaries in our share capital are not excluded from the right to vote on such shares, if the right of use and enjoyment (vruchtgebruik) or the right of pledge (pandrecht) was granted prior to the time such shares were acquired by us or any of our subsidiaries. Neither we nor any of our subsidiaries may cast votes in respect of a share on which we or such subsidiary holds a right of use and enjoyment (vruchtgebruik) or a right of pledge (pandrecht). Shares which are not entitled to voting rights pursuant to the preceding sentences will not be taken into account for the purpose of determining the number of shareholders that vote and that are present or represented, or the amount of the share capital that is provided or that is represented at a general meeting.
Decisions of the general meeting are taken by a simple majority of votes cast without an applicable quorum, except where Dutch law or our articles of association provide for a qualified majority and/or a quorum. Subject to any provision of mandatory Dutch law, if and for as long as the company is subject to the rules and requirements of the New York Stock Exchange, the Nasdaq Stock Market or on any other regulated stock exchange operating in the United States of America and such securities exchange requires the company to have a quorum for the general meeting, then the general meeting can only pass resolutions if at least one third of the issued and outstanding shares in the company's capital (being the part of the issued share capital of the company that is not held by the company itself) is represented at such general meeting. For each resolution passed at a general meeting, the voting results must be posted on our website within 15 days after the meeting.
The information posted will include the numbers of votes cast in favor, cast against and the abstentions, the total number of shares voted, the total number of votes cast and the percentage of our issued share capital represented by the total number of shares voted. The voting results must be kept accessible on the company’s website for a period of at least one year.
Directors
Appointment of directors
Under our articles of association, the directors are appointed by the general meeting upon binding nomination by our board of directors. However, the general meeting may at all times reject the nomination by a resolution adopted with a majority of the votes cast representing at least one third of the issued share capital. If the nomination is rejected by the majority of the votes cast, but such majority does not represent at least one third of the issued share capital, a new meeting may be convened in which the nomination may be rejected with a majority of the votes cast, irrespective of the percentage of our issued share capital represented at the meeting. In that event, the board of directors shall make a new nomination.
The board of directors has adopted a diversity and inclusion policy for the composition of our board of directors, as well as a profile for the composition of our board of directors. Our board of directors shall make any nomination for the appointment of a director with due regard to the rules and principles set forth in such diversity and inclusion policy and profile, as applicable.
At a general meeting, a resolution to appoint a director can only be passed in respect of candidates whose names are stated for that purpose in the agenda of that general meeting or in the explanatory notes thereto. Upon the appointment of a person as a director, the general meeting shall determine whether that person is appointed as executive director or as non-executive director.
Duties and liabilities of directors
Under Dutch law, the board of directors as a collective is responsible for our management, strategy, policy and operations. The executive directors manage our day-to-day business and operations and implement our strategy. The non-executive directors focus on the supervision on the policy and functioning of the performance of the duties of all directors and our general state of affairs. Our directors may divide their tasks among themselves in or pursuant to internal rules. Each director has a statutory duty to act in the corporate interest of the company and its business. Under Dutch law, the corporate interest extends to the interests of all corporate stakeholders, such as shareholders, creditors, employees, customers and suppliers. The duty to act in the corporate interest of the company also applies in the event of a proposed sale or break-up of the company, provided that the circumstances generally dictate how such duty is to be applied and how the respective interests of various groups of stakeholders should be weighed. Any resolution of the board of directors regarding a material change in our identity or character requires approval of the general meeting.
Our board of directors is authorised to represent the company. The power to represent the company also vests in the chief executive officer acting individually.
Dividends and other distributions
Amount available for distribution
We may only make distributions to our shareholders if our shareholders’ equity (eigen vermogen) exceeds the sum of the paid-up and called-up share capital plus any reserves required by Dutch law or by our articles of association from time to time. Our board of directors may decide that all or part of our profits shall be added to our reserves and any remaining profit will be at the disposal of the general meeting at the proposal of our board of directors for distribution on our ordinary shares, subject to restrictions of Dutch law.
We only make a distribution of profits to our shareholders after the adoption of our annual accounts demonstrating that such distribution is permitted. The board of directors is permitted, subject to certain requirements, to declare interim dividends without the approval of the general meeting.
Dividends and other distributions shall be payable ultimately fourteen days after the resolution to make the distribution. Claims to dividends and other distributions not made within five years from the date that such dividends or distributions became payable, will lapse and any such amounts will be considered to have been forfeited to us (verjaring).
Exchange controls
Under existing laws of the Netherlands, there are no exchange controls applicable to the transfer to persons outside of the Netherlands of dividends or other distributions with respect to, or of the proceeds from the sale of, shares of a Dutch company, subject to applicable restrictions under sanctions and measures, including those concerning export control, pursuant to European Union regulations, the Sanctions Act 1977 (Sanctiewet 1977) or other legislation, applicable anti-boycott, anti-money-laundering or anti-terrorism regulations and similar rules and provided that, under certain circumstances, payments of such dividends or other distributions must be reported to the Dutch Central Bank at their request for statistical purposes. There are no special restrictions in the articles of association or Dutch law that limit the right of shareholders who are not citizens or residents of the Netherlands to hold or vote shares.
Public offers
Under Dutch law, any shareholder who directly or indirectly obtains control of a Dutch listed company, such as us, is required to make a public offer for all issued and outstanding shares in that company’s share capital at a fair price. Such control is deemed present if a (legal) person is able to exercise, alone or acting in concert, at least 30% of the voting rights in the general meeting of such listed company (subject to certain exceptions, including a grandfathering exemption for major shareholders who, acting alone or in concert, already had control at the time of that company’s initial public offering). An additional exemption exists if such (legal) person, alone or acting in concert, reduces its holding below 30% within 30 days of the acquisition of control provided that: (i) the reduction of such (legal) person’s holding was not effected by a transfer of shares or depositary receipts to an exempted party; and (ii) during this period such (legal) person, alone or acting in concert, did not exercise its voting rights. In addition, it is prohibited to launch a public offer for shares of a listed Dutch company, such as our ordinary shares, unless an offer document has been approved by the competent authorities (which, for the company, would be the AFM (as defined below)). A public offer may only be launched by way of publication of an approved offer document unless a company makes an offer for its own shares.
Squeeze out procedures
A shareholder who - alone or together with group companies - for their own account holds at least 95% of our issued share capital may initiate proceedings against the other shareholders jointly for the transfer of their shares to such shareholder. The proceedings are held before the Enterprise Chamber (Ondernemingskamer) of the Amsterdam Court of Appeal, and can be instituted by means of a writ of summons served upon each of the other shareholders in accordance with the provisions of the Dutch Code of Civil Procedure (Wetboek van Burgerlijke Rechtsvordering).
The Enterprise Chamber may grant the claim for squeeze out in relation to the other shareholders and will determine the price to be paid for the shares, if necessary after appointment of one or three experts who will offer an opinion to the Enterprise Chamber on the value to be paid for the shares of the other shareholders. Once the order to transfer becomes final before the Enterprise Chamber, the person acquiring the shares shall give written notice of the date and place of payment and the price to the holders of the shares to be acquired whose addresses are known to him. Unless the addresses of all of them are known to the acquiring person, such person is required to publish the same in a daily newspaper with a national circulation.
In addition, an offeror under a public offer is entitled to start squeeze-out proceedings if, following the public offer, the offeror - alone or together with group companies - holds at least 95% of our issued share capital and represents at least 95% of the total voting rights in our general meeting. The claim of a takeover squeeze-out needs to be filed with the Enterprise Chamber within three months following the expiry of the acceptance period of the offer. The Enterprise Chamber may grant the claim for squeeze-out in relation to all minority shareholders and will determine a reasonable price to be paid for the shares, if necessary, after appointment of one or three experts who will offer an opinion to the Enterprise Chamber on the value to be paid for the shares of the minority shareholders. In principle, the offer price is considered reasonable if the offer was a mandatory offer or if at least 90% of the shares to which the offer related were received by way of voluntary offer.
Furthermore, minority shareholders that have not previously tendered their shares under a public offer may require that the offeror acquire their shares if the offeror has acquired at least 95% of our issued share capital and represents at least 95% of the total voting rights in our general meeting. With regard to price, the same procedure as for takeover squeeze-out proceedings initiated by an offeror applies. The claim also needs to be filed with the Enterprise Chamber within three months following the expiry of the acceptance period of the offer.
Dissolution and liquidation
Under our articles of association, we may be dissolved by a resolution of the general meeting, subject to a proposal of the board of directors. In the event of a dissolution, the liquidation shall be effected by the board of directors, unless the general meeting decides otherwise. During liquidation, the provisions of our articles of association will remain in force as far as possible. To the extent that any assets remain after payment of all debts, those assets shall be distributed to the holders of ordinary shares. All distributions referred to in this paragraph will be made in accordance with the relevant provisions of the laws of the Netherlands.
Dutch Financial Reporting Supervision Act
On the basis of the Dutch Financial Reporting Supervision Act (Wet toezicht financiele verslaggeving) (the “FRSA”), the Dutch Authority for the Financial Markets (Stichting Autoriteit Financiele Markten) (the “AFM”) supervises the application of financial reporting standards by Dutch companies whose securities are listed on a Dutch or foreign stock exchange.
Pursuant to the FRSA, the AFM has an independent right to (i) request an explanation from us regarding our application of the applicable financial reporting standards if, based on the publicly known facts or circumstances, it has reason to doubt that the company’s financial reporting meets such standards and (ii) recommend to us the making available of further explanations. If we do not comply with such a request or recommendation, the AFM may request that the Enterprise Chamber of the Amsterdam Court of Appeal (Ondernemingskamer) order us to (i) make available further explanations as recommended by the AFM (ii)
provide an explanation of the way we have applied the applicable financial reporting standards to our financial reports or (iii) prepare our financial reports in accordance with the Enterprise Chamber’s orders.
Disclosure of Substantial Holdings
Any person who, directly or indirectly, acquires or disposes of an actual or deemed interest in the capital or voting rights of the company must forthwith notify the AFM if as a result of such acquisition or disposal the percentage of capital interest or voting rights held (or deemed held) by such person in the company reaches, exceeds or falls below any of the following thresholds: 3%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60%, 75% and 95%.
A notification requirement also applies if a person’s capital interest or voting rights reaches, exceeds or falls below the above-mentioned thresholds as a result of a change in the company’s total outstanding share capital or voting rights. Such notification must be made no later than the fourth trading day after the AFM has published the company’s notification of the change in its outstanding share capital. The company is required to notify the AFM forthwith of the changes to its total share capital or voting rights if its issued share capital or voting rights changes by 1% or more since the company’s previous notification. The company must also notify the AFM within eight days after each quarter, in the event its share capital or voting rights changed by less than 1% in that relevant quarter since the company’s previous notification.
For the purpose of calculating the percentage of capital interest or voting rights under the rules outlined above, the following interests must, inter alia, be taken into account: (i) shares and voting rights directly held (or acquired or disposed of) by any person; (ii) shares and voting rights held (or acquired or disposed of) by such person’s controlled entity or by a third party for such person’s account or by a third party with whom such person has concluded an oral or written voting agreement; (iii) voting rights acquired pursuant to an agreement providing for a temporary transfer of voting rights against a payment; (iv) shares which such person (directly or indirectly) or third party referred to above, may acquire pursuant to any option or other right to acquire shares; (v) shares that determine the value of certain cash settled financial instruments such as contracts for difference and total return swaps; (vi) shares that must be acquired upon exercise of a put option by a counterparty; and (vii) shares that are the subject of another contract creating an economic position similar to a direct or indirect holding in those shares. Special attribution rules apply to shares and voting rights that are part of the property of a partnership or other community of property. A holder of a pledge or right of use and enjoyment in respect of shares can also be subject to the reporting obligations, if such person has, or can acquire, the right to vote the shares. The acquisition of (conditional) voting rights by a pledgee or beneficial owner may also trigger the reporting obligations as if the pledgee or beneficial owner were the legal holder of the shares.
For the purpose of calculating the percentage of capital interest or voting rights, the following instruments qualify as “shares”: (i) shares, (ii) depositary receipts for shares (or negotiable instruments similar to such receipts), (iii) negotiable instruments for acquiring the instruments under (i) or (ii) (such as convertible bonds), and (iv) options for acquiring the instruments under (i) or (ii).
Disclosure of Short Positions
Each person holding a gross short position in relation to our issued share capital that reaches, exceeds or falls below any one of the following thresholds: 3%, 5%, 10 %, 15%, 20%, 25%, 30%, 40%, 50%, 60%, 75% and 95%, must forthwith give written notice to the AFM. If a person’s gross short position reaches, exceeds or falls below one of the above-mentioned thresholds as a result of a change in the company’s issued share capital, such person must make a notification not later than the fourth trading day after the AFM has published the company’s notification in the public register of the AFM.
In addition, any natural or legal person holding a net short position equal or exceeding 0.1% of the issued share capital of a Dutch listed company is required to notify such position to the AFM. Each subsequent increase of this position by 0.1% above 0.1% must also be notified. Each net short position exceeding 0.5% of the issued share capital of a Dutch listed company and any subsequent increase of that position by 0.1% will be made public by the AFM. To calculate whether a natural person or legal person has a net short position, their short positions and long positions must be set off.
Market Abuse Rules
Insider dealing and market manipulation prohibitions
Pursuant to the European Market Abuse Regulation, no natural or legal person is permitted to: (i) engage or attempt to engage in insider dealing in financial instruments listed on a regulated market or for which a listing has been requested, such as the ordinary shares, (ii) recommend that another person engages in insider dealing or induce another person to engage in insider dealing or (iii) unlawfully disclose inside information relating to the ordinary shares or the company. Furthermore, no person may engage in or attempt to engage in market manipulation.
Public disclosure of inside information
We are required to inform the public as soon as possible and in a manner that enables fast access and complete, correct and timely assessment of the information, of inside information which directly concerns the company. Pursuant to the European Market Abuse Regulation, inside information is information of a precise nature, which has not been made public, relating, directly or indirectly, to one or more issuers or to one or more financial instruments, and which, if it were made public, would be likely to have a significant effect on the prices of those financial instruments or on the price of related derivative financial instruments. An intermediate step in a protracted process can also be deemed to be inside information. The company is required to post and maintain on its website all inside information for a period of at least five years. Under certain circumstances, the disclosure of inside information may be delayed, which needs to be notified to the AFM after the disclosure has been made.
Upon request of the AFM, a written explanation needs to be provided setting out why a delay of the publication was considered permitted.
Insiders lists
The company and any person acting on its behalf or on its account are obligated to draw up an insiders’ list of officers, employees and other persons working for the company with access to inside information relating to the company, to promptly update the insider list and provide the insider list to the AFM upon its request. the company and any person acting on its behalf or on its account are obligated to take all reasonable steps to ensure that any person on the insider list acknowledges in writing the legal and regulatory duties entailed and is aware of the sanctions applicable to insider dealing and unlawful disclosure of inside information.
Managers’ transactions
In addition to the notification obligations for persons discharging managerial responsibilities (and persons closely associated with them) mentioned above, a person discharging managerial responsibilities is not permitted to (directly or indirectly) conduct any transactions on its own account or for the account of a third party, relating to our ordinary shares or debt instruments of the company or other financial instruments linked thereto, during a closed period of 30 calendar days before the announcement of a half-yearly report or the annual report of the company.
The company is required to draw up a list of all persons discharging managerial responsibilities and persons closely associated with them and notify persons discharging managerial responsibilities of their obligations in writing. Persons discharging managerial responsibilities are required to notify the persons closely associated with them of their obligations in writing.
Non-compliance with Market Abuse Rules
In accordance with the Market Abuse Regulation, the AFM has the power to take appropriate administrative sanctions, such as fines, and/or other administrative measures in relation to possible infringements.
Non-compliance with the market abuse rules set out above could also constitute an economic offense and/or a crime (misdrijf) and could lead to the imposition of administrative fines by the AFM. The public prosecutor could press criminal charges resulting in fines or imprisonment. If criminal charges are pressed, it is no longer allowed to impose administrative penalties and vice versa. The AFM shall in principle also publish any decision imposing an administrative sanction or measure in relation to an infringement of the Market Abuse Regulation.
Comparison of Dutch corporate law and our articles of association and U.S. corporate law
The following comparison between Dutch corporate law, which applies to us, and Delaware corporation law, the law under which many publicly listed corporations in the United States are incorporated, discusses additional matters not otherwise described in this description. Although we believe this summary is materially accurate, the summary is subject to Dutch law, including Book 2 of the Dutch Civil Code and the DCGC and Delaware corporation law, including the Delaware General Corporation Law.
Corporate governance
Duties of directors
The Netherlands. We have a one-tier board structure consisting of one or more executive directors and one or more non-executive directors.
Under Dutch law, the board of directors as a collective is responsible for the management and the strategy, policy and operations of the company. The executive directors manage our day-to-day business and operations and implement our strategy. The non-executive directors focus on the supervision on the policy and functioning of the performance of the duties of all directors and our general state of affairs. Our directors may divide their tasks among themselves in or pursuant to internal rules. Each director has a statutory duty to act in the corporate interest of the company and its business. Under Dutch law, the corporate interest extends to the interests of all corporate stakeholders, such as shareholders, creditors, employees, customers and suppliers. The duty to act in the corporate interest of the company also applies in the event of a proposed sale or break-up of the company, provided that the circumstances generally dictate how such duty is to be applied and how the respective interests of various groups of stakeholders should be weighed. Any resolution of the board of directors regarding a material change in the identity or character of the company requires the approval of the general meeting.
Our board of directors is authorised to represent the company. The power to represent the company also vests in the chief executive officer acting individually.
Delaware. The board of directors bears the ultimate responsibility for managing the business and affairs of a corporation. In discharging this function, directors of a Delaware corporation owe fiduciary duties of care and loyalty to the corporation and to its stockholders. Delaware courts have decided that the directors of a Delaware corporation are required to exercise informed business judgment in the performance of their duties. Informed business judgment means that the directors have informed themselves of all material information reasonably available to them. Delaware courts have also imposed a heightened standard of conduct upon directors of a Delaware corporation who take any action designed to defeat a threatened change in control of the corporation. In addition, under Delaware law, when the board of directors of a Delaware corporation approves the sale or break-up of a corporation, the board of directors may, in certain circumstances, have a duty to obtain the highest value reasonably available to the stockholders.
Director terms
The Netherlands. The DCGC provides the following best practice recommendations on the terms for directors’ service:
•Executive directors should be appointed for a maximum period of four years, without limiting the number of consecutive terms executive directors may serve.
•Non-executive directors should be appointed for two consecutive periods of no more than four years. Thereafter, non-executive directors may be reappointed for a maximum of two consecutive periods of no more than two years, provided that any reappointment after an eight-year term of office should be disclosed in the company’s annual board report.
The general meeting shall at all times be entitled to suspend or remove a director. Under our articles of association, the general meeting may adopt a resolution to suspend or remove such director by a majority of the votes cast, provided such majority represents more than one third of the issued share capital. If the majority of the votes cast are in favor of the proposal to suspend or remove a director, but such majority does not represent at least one third of the issued share capital, a new meeting may be convened in which the director concerned may be suspended or removed with a majority of the votes cast.
Delaware. The Delaware General Corporation Law generally provides for a one-year term for directors, but permits directorships to be divided into up to three classes with up to three-year terms, with the years for each class expiring in different years, if permitted by the certificate of incorporation, an initial bylaw or a bylaw adopted by the stockholders. A director elected to serve a term on a “classified” board may not be removed by stockholders without cause. There is no limit in the number of terms a director may serve.
Director vacancies
The Netherlands. Under Dutch law, directors are appointed and reappointed by the general meeting. Under our articles of association, directors are appointed by the general meeting upon the binding nomination by our board of directors. However, the general meeting may at all times reject the nomination by a resolution adopted with a majority of the votes cast representing at least one third of the issued share capital. If the nomination is rejected by the majority of the votes cast, but such majority does not represent at least one third of the issued share capital, a new meeting may be convened in which the nomination may be rejected with a majority of the votes cast, irrespective of the percentage of our issued share capital represented at the meeting. In that event, the board of directors shall make a new nomination.
In addition, under our articles of association, if a director is no longer in office or is unable to act, that director may be replaced temporarily by a person whom the board of directors has designated for that purpose. If no directors are in office or all of them are unable to act, the general meeting shall appoint one or more persons who will temporarily be charged with the company’s management.
Delaware. The Delaware General Corporation Law provides that vacancies and newly created directorships may be filled by a majority of the directors then in office (even though less than a quorum) unless (i) otherwise provided in the certificate of incorporation or bylaws of the corporation or (ii) the certificate of incorporation directs that a particular class of stock is to elect such director, in which case any other directors elected by such class, or a sole remaining director elected by such class, will fill such vacancy.
Conflict-of-interest transactions
The Netherlands. Under Dutch law and our articles of association, our directors shall not take part in any discussion or decision-making that involves a subject or transaction in relation to which such director has a conflict of interest with us. Our articles of association provide that if as a result thereof no resolution of the board of directors can be adopted, the resolution can nonetheless be adopted by the board of directors as if none of the directors had a conflict of interest. In that case, each director is entitled to participate in the discussion and decision-making process and to cast a vote. These rules apply mutatis mutandis with respect to decision-making relating to related party transactions (as defined by Dutch law) in which a director is involved.
The DCGC provides the following best practice recommendations in relation to conflicts of interests:
•a director should report any potential conflict of interest in a transaction that is of material significance to the company and/or to such director to the other directors without delay, providing all relevant information in relation to the conflict;
•the board of directors should then decide, outside the presence of the director concerned, whether there is a conflict of interest;
•transactions in which there is a conflict of interest with a director should be agreed on arms’ length terms; and
•a decision to enter into such a transaction in which there is a conflict of interest with a director that is of material significance to the company and/or to such director shall require the approval of the board of directors, and such transactions should be disclosed in the company’s annual board report, together with a description of the conflict of interest and a declaration that the relevant best practice provisions of the DCGC have been complied with.
Delaware. The Delaware General Corporation Law generally permits transactions involving a Delaware corporation and an interested director of that corporation if:
•the material facts as to the director’s relationship or interest are disclosed and a majority of disinterested directors consent;
•the material facts are disclosed as to the director’s relationship or interest and a majority of shares entitled to vote thereon consent; or
•the transaction is fair to the corporation at the time it is authorized by the board of directors, a committee of the board of directors or the stockholders.
Proxy voting by directors
The Netherlands. An absent director may issue a proxy for a specific board meeting but only to another director in writing.
Delaware. A director of a Delaware corporation may not issue a proxy representing the director’s voting rights as a director.
Dutch Corporate Governance Code (DCGC)
The DCGC contains both principles and best practice provisions for boards of directors, shareholders and general meetings of shareholders, financial reporting, auditors, disclosure, compliance and enforcement standards. A copy of the DCGC can be found on www.mccg.nl. As a Dutch company listed on a stock exchange, we are subject to the DCGC and are required to disclose in our annual report to what we extent comply with the principles and best practice provisions of the DCGC, and where we do not (for example, because of a conflicting Nasdaq requirement or otherwise), we must state why and to what extent we deviate in our annual report. Our most substantial deviations from the DCGC are summarized below.
•The DCGC recommends companies to draw up a policy to facilitate dialogues with relevant stakeholders of the company on sustainability aspects of the long-term strategy. While the stakeholder analysis is already covered by the ESG Program, the policy is being drafted within the framework of that Program, building on the existing investor dialogue policy. The policy is expected to be published on the website in the course of 2024.
•The DCGC recommends against providing equity awards as part of the compensation of a non-executive director. However, we deviate from this recommendation and grant equity awards to our non-executive directors, consistent with U.S. market practice and in accordance with the remuneration policy for our board of directors. To safeguard the independence of the non-executive directors, consistent with the intentions of the DCGC, the number of shares awarded has been fixed and the grant has not been linked to the company’s performance.
•The DCGC recommends that all analyst meetings, analyst presentations, presentations to institutional or other investors and press conferences can be followed in real time, by means of webcasting, telephone or otherwise. Considering the company’s size, it would create an excessive burden to provide facilities that enable shareholders to follow in real time all the meetings with analysts, presentations to analysts, presentations to investors referred to in the best practice provision. However, the company ensures that presentations are posted on the website in a timely fashion. Some meetings (such as the annual general meeting) are accessible in real time at least in audio format. The company also holds both pre-recorded and live webinars at which key events such as quarterly financial statements or large corporate actions can be discussed. Meetings discussing financial results and other significant news will be announced and conducted in accordance with this provision.
Shareholder rights
Voting rights
The Netherlands. In accordance with Dutch law and our Articles of Association, each issued ordinary share confers the right to cast one vote at the general meeting. Each holder of shares may cast as many votes as it holds shares. No votes may be cast on shares that are held by us or our direct or indirect subsidiaries or on shares for which we or our subsidiaries hold depository receipts. Nonetheless, the holders of a right of use and enjoyment (vruchtgebruik) and the holders of a right of pledge (pandrecht) in respect of shares held by us or our subsidiaries in our share capital are not excluded from the right to vote on such shares, if the right of use and enjoyment (vruchtgebruik) or the right of pledge (pandrecht) was granted prior to the time such shares were acquired by us or any of our subsidiaries. Neither we nor any of our subsidiaries may cast votes in respect of a share on which we or such subsidiary holds a right of use and enjoyment (vruchtgebruik) or a right of pledge (pandrecht).
Shareholders may exercise voting rights, if they are the holders of shares on the record date, if any, as required by Dutch law, which is currently the 28th day before the day of the general meeting. Under our articles of association, rights may only be exercised, if the persons entitled to attend the meeting have announced to the board of directors in writing at least seven (7) days prior to the meeting (or such shorter period prior to the meeting as allowed by the board of directors in view of special circumstances), that they intend to attend the meeting personally, or that they shall be represented by proxy. The record date and the manner in which shareholders can register and exercise their rights will be set out in the notice of the meeting.
Delaware. Under the Delaware General Corporation Law, each stockholder is entitled to one vote per share of stock, unless the certificate of incorporation provides otherwise. In addition, the certificate of incorporation may provide for cumulative voting at all elections of directors of the corporation, or at elections held under specified circumstances. Either the certificate of incorporation or the bylaws may specify the number of shares and/or the amount of other securities that must be represented at a meeting in order to constitute a quorum, but in no event will a quorum consist of less than one-third of the shares entitled to vote at a meeting.
Stockholders as of the record date for the meeting are entitled to vote at the meeting, and the board of directors may fix a record date that is no more than 60 nor less than 10 days before the date of the meeting, and if no record date is set then the record date is the close of business on the day next preceding the day on which notice is given, or if notice is waived then the record date is the close of business on the day next preceding the day on which the meeting is held. The determination of the stockholders of record entitled to notice or to vote at a meeting of stockholders shall apply to any adjournment of the meeting, but the board of directors may fix a new record date for the adjourned meeting.
Shareholder proposals
The Netherlands. Pursuant to our Articles of Association, extraordinary general meetings of shareholders will be held whenever required under Dutch law or whenever our board of directors deems such to be appropriate or necessary. Pursuant to Dutch law, one or more shareholders or others with meeting rights under Dutch law representing at least one-tenth of the issued share capital may request us to convene a general meeting, setting out in detail the matters to be discussed. If our board of directors has not taken the steps necessary to ensure that such meeting can be held within eight weeks after the request, the proponent(s) may, on their application, be authorized by the competent Dutch court in preliminary relief proceedings to convene a general meeting. The court shall disallow the application if it does not appear that the proponent(s) has/have previously requested our board of directors to convene a general meeting and our board of directors has not taken the necessary steps so that the general meeting could be held within eight weeks after the request. The application shall also be disallowed if the proponent(s) has/have not demonstrated to have a reasonable interest in the convening of the general meeting.
Also, the agenda for a general meeting shall include such items requested by one or more shareholders, and others entitled to attend general meetings of shareholders, representing at least 3% of the issued share capital, except where the articles of association state a lower percentage. Our Articles of Association do not state such lower percentage. Requests must be made in writing and received by the board of directors at least 60 days before the day of the meeting. No resolutions shall be adopted on items other than those that have been included in the agenda. A shareholder exercising its right to put an item on the agenda must notify the company, in its request, of the following information (in case the right is exercised by multiple shareholders, the information listed below may be aggregated):
(a)the percentage of the issued share capital represented by the ordinary shares which are, or are deemed to be (under the applicable Dutch attribution rules), at the disposal of such shareholder; and
(b)the percentage of the issued share capital represented by the financial instruments which are at the disposal of such shareholder and which constitute a short position with respect to ordinary shares.
In accordance with the DCGC, a shareholder shall exercise the right of putting an item on the agenda or to request convening of a general meeting only after consulting the board of directors in that respect. If exercising such rights may result in a change in the company’s strategy (e.g. the removal of directors), the board of directors should be given the opportunity to invoke a reasonable response time of up to 180 days from the moment the board of directors is informed of the intentions of the shareholder(s). If invoked, the board of directors shall use such response period for further deliberation and constructive consultation, in any event with the shareholders concerned, and shall explore alternatives. At the end of the response time, the board of directors shall report on this consultation and the exploration of alternatives to the general meeting. The response period may be invoked only once for any given general meeting and shall not apply: (a) in respect of a matter for which a response period or a statutory cooling-off period (as discussed below) has been previously invoked; or (b) if a shareholder holds at least 75% of the company’s issued share capital as a consequence of a successful public bid.
Moreover, our board of directors can invoke a cooling-off period of up to 250 days when shareholders, using their right to have items added to the agenda for a general meeting or their right to request a general meeting, propose an agenda item for our general meeting to dismiss, suspend or appoint one or more directors (or to amend any provision in our articles of association dealing with those matters) or when a public offer for our company is made or announced without our support, provided, in each case, that our board of directors believes that such proposal or offer materially conflicts with the interests of our company and its business. During a cooling-off period, our general meeting cannot dismiss, suspend or appoint directors (or amend the provisions in our articles of association dealing with those matters) except at the proposal of our board of directors. During a cooling-off period, our board of directors must gather all relevant information necessary for a careful decision-making process and at least consult with shareholders representing 3% or more of our issued share capital at the time the cooling-off period was invoked, as well as with our Dutch works council (if we or, under certain circumstances, any of our subsidiaries would have one). Formal statements expressed by these stakeholders during such consultations must be published on our website to the extent these stakeholders have approved that publication. Ultimately one week following the last day of the cooling-off period, our board of directors must publish a report in respect of its policy and conduct of affairs during the cooling-off period on our website. This report must remain available for inspection by shareholders and others with meeting rights under Dutch law at our office and must be tabled for discussion at the next general meeting. Shareholders representing at least 3% of our issued share capital may request the Enterprise Chamber for early termination of the cooling-off period. The Enterprise Chamber must rule in favor of the request if the shareholders can demonstrate that:
•our board of directors, in light of the circumstances at hand when the cooling-off period was invoked, could not reasonably have concluded that the relevant proposal or hostile offer constituted a material conflict with the interests of our company and its business;
•our board of directors cannot reasonably believe that a continuation of the cooling-off period would contribute to careful policy-making; or
•other defensive measures, having the same purpose, nature and scope as the cooling-off period, have been activated during the cooling-off period and have not since been terminated or suspended within a reasonable period at the relevant shareholders’ request (i.e., no ‘stacking’ of defensive measures).
Delaware. Delaware law does not specifically grant stockholders the right to bring business before an annual or special meeting. However, if a Delaware corporation is subject to the SEC’s proxy rules, a stockholder who owns at least £2,000 in market value, or 1% of the corporation’s securities entitled to vote, and has owned such securities for at least one year, may propose a matter for a vote at an annual or special meeting in accordance with those rules.
Action by written consent
The Netherlands. Under Dutch law, shareholders’ resolutions may be adopted in writing without holding a meeting of shareholders, provided that (i) the articles of association allow such action by written consent, (ii) the company has not issued bearer shares or, with its cooperation, depository receipts for shares in its capital, and (iii) the resolution is adopted unanimously by all shareholders that are entitled to vote. The requirement of unanimity renders the adoption of shareholder resolutions without holding a meeting not feasible for us as a publicly traded company.
Delaware. Although permitted by Delaware law, publicly listed companies do not typically permit stockholders of a corporation to take action by written consent.
Appraisal rights
The Netherlands. Subject to certain exceptions, Dutch law does not recognize the concept of appraisal or dissenters’ rights. However, Dutch law does provide for squeeze-out procedures as described under “Ordinary Shares —Squeeze out procedures.” Also, Dutch law provides for cash exit rights in certain situations for dissenting shareholders of a company organized under Dutch law entering into certain types of mergers. In those situations, a dissenting shareholder may file a claim with the Dutch company for compensation. Such compensation shall then be determined by one or more independent experts. The shares of such shareholder that are subject to such claim will cease to exist as of the moment of entry into effect of the merger.
Delaware. The Delaware General Corporation Law provides for stockholder appraisal rights, or the right to demand payment in cash of the judicially determined fair value of the stockholder’s shares, in connection with certain mergers and consolidations.
Shareholder suits
The Netherlands. In the event a third party is liable to a Dutch company, only the company itself can bring a civil action against that party. The individual shareholders do not have the right to bring an action on behalf of the company. Only in the event that the cause for the liability of a third party to the company also constitutes a tortious act directly against a shareholder does that shareholder have an individual right of action against such third party in its own name.
Dutch law provides for the possibility to initiate such actions collectively, in which a foundation or an association can act as a class representative and has standing to commence proceedings and claim damages if certain criteria are met. The court will first determine if those criteria are met. If so, the case will go forward as a class action on the merits after a period allowing class members to opt out from the case has lapsed. All members of the class who are residents of the Netherlands and who did not opt-out will be bound to the outcome of the case. Residents of other countries must actively opt in in order to be able to benefit from the class action. The defendant is not required to file defenses on the merits prior to the merits phase having commenced. It is possible for the parties to reach a settlement during the merits phase. Such a settlement can be approved by the court, which approval will then bind the members of the class, subject to a second opt-out. This regime applies to claims brought after January 1, 2020 and which relate to certain events that occurred prior to that date. For other matters, the old Dutch class actions regime will apply. Under the old regime, no monetary damages can be sought. Also, a judgment rendered under the old regime will not bind individual class members. Even though Dutch law does not provide for derivative suits, directors and officers can still be subject to liability under U.S. securities laws.
Delaware. Under the Delaware General Corporation Law, a stockholder may bring a derivative action on behalf of the corporation to enforce the rights of the corporation. An individual also may commence a class action suit on behalf of himself and other similarly situated stockholders where the requirements for maintaining a class action under Delaware law have been met. A person may institute and maintain such a suit only if that person was a stockholder at the time of the transaction which is the subject of the suit. In addition, under Delaware case law, the plaintiff normally must be a stockholder at the time of the transaction that is the subject of the suit and throughout the duration of the derivative suit. Delaware law also requires that the derivative plaintiff make a demand on the directors of the corporation to assert the corporate claim before the suit may be prosecuted by the derivative plaintiff in court, unless such a demand would be futile.
Repurchase of shares
The Netherlands. Under Dutch law, when issuing shares, a public company with limited liability such as ours may not subscribe for newly issued shares in its own capital. Such company may, however, subject to certain restrictions of Dutch law and its articles of association, acquire shares in its own capital. A listed public company with limited liability such as ours may acquire fully paid shares in its own capital at any time for no valuable consideration. Furthermore, subject to certain provisions of Dutch law and its articles of association, such company may repurchase fully paid shares in its own capital if (i) the company’s shareholders’ equity less the payment required to make the acquisition does not fall below the sum of paid-up and called-up share capital plus any reserves required by Dutch law or its articles of association and (ii) the aggregate nominal value of shares of the company which the company acquires, holds or on which the company holds a pledge (pandrecht) or which are held by a subsidiary of the company, would not exceed 50% of its then current issued share capital. Such company may only acquire its own shares if its general meeting has granted the board of directors the authority to effect such acquisitions.
An acquisition of ordinary shares for a consideration must be authorized by our general meeting. Such authorization may be granted for a maximum period of 18 months and must specify the number of ordinary shares that may be acquired, the manner in which ordinary shares may be acquired and the price limits within which ordinary shares may be acquired. Authorization is not required for the acquisition of ordinary shares in order to transfer them to our employees. The actual acquisition may only be effected by a resolution of our board of directors. As at May 17, 2023, our board of directors has been authorized, for a period of eighteen months starting on May 17, 2023, to repurchase not more than 10% of the issued share capital, for a price not less than the nominal value and not exceeding 100% of the average final closing rates as listed in the Official Price Gazette of Euronext Amsterdam N.V. during five consecutive days prior to the date of repurchase (such average market price being the average of the closing prices on each of the five consecutive trading days preceding the date the acquisition is agreed upon by us).
No authorization of the general meeting is required if ordinary shares are acquired by us with the intention of transferring such ordinary shares to our employees under an applicable employee stock purchase plan.
Delaware. Under the Delaware General Corporation Law, a corporation may purchase or redeem its own shares unless the capital of the corporation is impaired or the purchase or redemption would cause an impairment of the capital of the corporation. A Delaware corporation may, however, purchase or redeem out of capital any of its preferred shares or, if no preferred shares are outstanding, any of its own shares if such shares will be retired upon acquisition and the capital of the corporation will be reduced in accordance with specified limitations.
Anti-Takeover Provisions
The Netherlands. Under Dutch law, various protective measures are possible and permissible within the boundaries set by Dutch law and Dutch case law. We have adopted several provisions that may have the effect of making a takeover of our company more difficult or less attractive, including:
•a provision that our directors may only be removed at the general meeting by a resolution adopted with a majority of the votes cast, representing at least one third of our issued share capital; if the majority of the votes cast are cast in favor of the removal, but such majority does not represent at least one third of the issued share capital, a new meeting may be convened in which the removal may be resolved upon with a majority of the votes cast, irrespective of the percentage of our issued share capital represented at the meeting;
•our directors being appointed on the basis of a binding nomination by our board of directors, which can only be overruled by the general meeting by a resolution adopted with the majority of the votes cast, provided such majority represents at least one third of the issued share capital; if the nomination is rejected by the majority of the votes cast, but such majority does not represent at least one third of the issued share capital, a new meeting may be convened in which the nomination may be rejected with a majority of the votes cast, irrespective of the percentage of our issued share capital represented at the meeting; in that event, the board of directors shall make a new nomination; and
•requirements that certain matters, including an amendment of our articles of association or our dissolution, may only be brought to our shareholders for a vote upon a proposal by our board of directors.
Dutch law also allows for staggered multi-year terms of our directors, as a result of which only part of our directors may be subject to appointment or re-appointment in any given year.
Furthermore, our board of directors may, under certain circumstances invoke a reasonable period of up to 180 days to respond to certain shareholder proposals or a statutory cooling-off period of up to 250 days to respond to certain shareholder proposals or a hostile bid. See above under “Shareholder Proposals.”
Delaware. In addition to other aspects of Delaware law governing fiduciary duties of directors during a potential takeover, the Delaware General Corporation Law also contains a business combination statute that protects Delaware companies from hostile takeovers and from actions following the takeover by prohibiting some transactions once an acquirer has gained a significant holding in the corporation.
Section 203 of the Delaware General Corporation Law prohibits “business combinations,” including mergers, sales and leases of assets, issuances of securities and similar transactions by a corporation or a subsidiary with an interested stockholder that beneficially owns 15% or more of a corporation’s voting stock, within three years after the person becomes an interested stockholder, unless:
•the transaction that will cause the person to become an interested stockholder is approved by the board of directors of the target prior to the transactions;
•after the completion of the transaction in which the person becomes an interested stockholder, the interested stockholder holds at least 85% of the voting stock of the corporation not including shares owned by persons who are directors and officers of interested stockholders and shares owned by specified employee benefit plans; or
•after the person becomes an interested stockholder, the business combination is approved by the board of directors of the corporation and holders of at least 66.67% of the outstanding voting stock, excluding shares held by the interested stockholder.
A Delaware corporation may elect not to be governed by Section 203 by a provision contained in the original certificate of incorporation of the corporation or an amendment to the original certificate of incorporation or to the bylaws of the company, which amendment must be approved by a majority of the shares entitled to vote and may not be further amended by the board of directors of the corporation. In most cases, such an amendment is not effective until 12 months following its adoption.
Inspection of Books and Records
The Netherlands. The board of directors provides the general meeting, within a reasonable amount of time with all information that the shareholders require for the exercise of their powers, unless this would be contrary to an overriding interest of our company. If the board of directors invokes such an overriding interest, it must give reasons.
Delaware. Under the Delaware General Corporation Law, any stockholder may inspect for any proper purpose certain of the corporation’s books and records during the corporation’s usual hours of business.
Removal of directors
The Netherlands. Under our Articles of Association, the general meeting shall at all times be entitled to suspend or remove a director. The general meeting may only adopt a resolution to suspend or remove a director by with a majority of the votes cast, representing at least one third the issued share capital. If the majority of the votes cast are in favor of the proposal to suspend or remove a director, but such majority does not represent at least one third of the issued share capital, a new meeting may be convened in which the director concerned may be suspended or removed with a majority of the votes cast.
Delaware. Under the Delaware General Corporation Law, any director or the entire board of directors may be removed, with or without cause, by the holders of a majority of the shares then entitled to vote at an election of directors, except (i) unless the certificate of incorporation provides otherwise, in the case of a corporation whose board is classified, stockholders may effect such removal only for cause, or (ii) in the case of a corporation having cumulative voting, if less than the entire board is to be removed, no director may be removed without cause if the votes cast against their removal would be sufficient to elect that director if then cumulatively voted at an election of the entire board of directors, or, if there are classes of directors, at an election of the class of directors of which he is a part.
Issuance of shares
The Netherlands. Under Dutch law, a company’s general meeting is the corporate body authorized to resolve on the issuance of shares and the granting of rights to subscribe for shares. The general meeting can delegate such authority to another corporate body of the company, such as the board of directors, for a period not exceeding five years, upon proposal of the board of directors.
As at May 17, 2023, our board of directors has been authorized, for a period of eighteen months starting on May 17, 2023, to issue shares and grant rights to acquire shares up to 10% of the issued share capital (as per May 17, 2023).
Delaware. All creation of shares require the board of directors to adopt a resolution or resolutions, pursuant to authority expressly vested in the board of directors by the provisions of the company’s certificate of incorporation.
Preemptive rights
The Netherlands. Under Dutch law, in the event of an issuance of ordinary shares, each shareholder will have a pro rata preemptive right in proportion to the aggregate nominal value of the ordinary shares held by such holder (with the exception of ordinary shares to be issued to employees or ordinary shares issued against a contribution other than in cash or pursuant to the exercise of a previously acquired right to subscribe for shares). Under our articles of association, the preemptive rights in respect of newly issued ordinary shares may be restricted or excluded by a resolution of the general meeting upon proposal of the board of directors.
The board of directors may restrict or exclude the preemptive rights in respect of newly issued ordinary shares if it has been designated as the authorized body to do so by the general meeting. Such designation can be granted for a period not exceeding five years. A resolution of the general meeting to restrict or exclude the preemptive rights or to designate the board of directors as the authorized body to do so requires a majority of not less than two-thirds of the votes cast, if less than one-half of our issued share capital is represented at the meeting.
As at May 17, 2023, our board of directors has been authorized, for a period of eighteen months starting on May 17, 2023, to limit or exclude preemptive rights in relation to an issuance of shares or a grant of rights to subscribe for shares that the board of directors is authorized to resolve upon (see above under “Issuance of shares”).
Delaware. Under the Delaware General Corporation Law, stockholders have no preemptive rights to subscribe for additional issues of stock or to any security convertible into such stock unless, and to the extent that, such rights are expressly provided for in the certificate of incorporation.
Dividends
The Netherlands. We may only make distributions to our shareholders if our shareholders’ equity (eigen vermogen) exceeds the sum of the paid-up and called-up share capital plus any reserves required by Dutch law or by our articles of association from time to time. Our board of directors may decide that all or part of our profits shall be added to our reserves and any remaining profit will be at the disposal of the general meeting at the proposal of our board of directors for distribution on our ordinary shares, subject to restrictions of Dutch law.
We only make a distribution of profits to our shareholders after the adoption of our annual accounts demonstrating that such distribution is permitted. The board of directors is permitted, subject to certain requirements, to declare interim dividends without the approval of the general meeting.
Dividends and other distributions shall be payable ultimately fourteen days after the resolution to make the distribution. Claims to dividends and other distributions not made within five years from the date that such dividends or distributions became payable, will lapse and any such amounts will be considered to have been forfeited to us (verjaring).
Delaware. Under the Delaware General Corporation Law, a Delaware corporation may pay dividends out of its surplus (the excess of net assets over capital), or in case there is no surplus, out of its net profits for the fiscal year in which the dividend is declared and/or the preceding fiscal year (provided that the amount of the capital of the corporation is not less than the aggregate amount of the capital represented by the issued and outstanding stock of all classes having a preference upon the distribution of assets). In determining the amount of surplus of a Delaware corporation, the assets of the corporation, including stock of subsidiaries owned by the corporation, must be valued at their fair market value as determined by the board of directors, without regard to their historical book value. Dividends may be paid in the form of common stock, property or cash.
Shareholder vote on certain reorganizations
The Netherlands. Under Dutch law, the general meeting must approve resolutions of the board of directors relating to a significant change in the identity or the character of the company or the business of the company, which includes:
•a transfer of the business or virtually the entire business to a third party;
•the entry into or termination of a long-term cooperation of the company or a subsidiary with another legal entity or company or as a fully liable partner in a limited partnership or general partnership, if such cooperation or termination is of a far-reaching significance for the company; and
•the acquisition or divestment by the company or a subsidiary of a participating interest in the capital of a company having a value of at least one-third of the amount of its assets according to its balance sheet and explanatory notes or, if the company prepares a consolidated balance sheet, according to its consolidated balance sheet and explanatory notes in the last adopted annual accounts of the company.
The absence of such approval shall result in the relevant resolution being null and void but shall not affect the powers of representation of the board of directors or of the executive directors.
Delaware. Under the Delaware General Corporation Law, the vote of a majority of the outstanding shares of capital stock entitled to vote thereon generally is necessary to approve a merger or consolidation or the sale of all or substantially all of the assets of a corporation. The Delaware General Corporation Law permits a corporation to include in its certificate of incorporation a provision requiring for any corporate action the vote of a larger portion of the stock or of any class or series of stock than would otherwise be required.
Under the Delaware General Corporation Law, no vote of the stockholders of a surviving corporation to a merger is needed, however, unless required by the certificate of incorporation, if (i) the agreement of merger does not amend in any respect the certificate of incorporation of the surviving corporation, (ii) the shares of stock of the surviving corporation are not changed in the merger, and (iii) the number of shares of common stock of the surviving corporation into which any other shares, securities or obligations to be issued in the merger may be converted does not exceed 20% of the surviving corporation’s common stock outstanding immediately prior to the effective date of the merger.
In addition, stockholders may not be entitled to vote in certain mergers with other corporations that own 90% or more of the outstanding shares of each class of stock of such corporation, but the stockholders will be entitled to appraisal rights.
Remuneration of directors
The Netherlands. Under Dutch law and our articles of association, we must adopt a remuneration policy for our board of directors. Such remuneration policy shall be subject to approval by the general meeting upon the proposal of the board of directors. The remuneration policy shall be proposed for approval by the general meeting at least once every four years. A resolution to approve the remuneration policy requires a majority of at least seventy-five percent of the votes cast. The board of directors determines the remuneration of individual directors with due observance of the remuneration policy. Annually, our remuneration report detailing the implementation of our remuneration policy over the financial year concerned will be put to the general meeting for an advisory vote. Our executive directors may not participate in the discussions or decision-making regarding the remuneration of executive directors. A proposal by the board of directors with respect to remuneration schemes in the form of shares or rights to shares will be subject to the approval of the general meeting. This proposal must set out at least the maximum number of shares or rights to subscribe for shares to be granted to the board of directors and the criteria for granting or amendment.
Delaware. Under the Delaware General Corporation Law, the stockholders do not generally have the right to approve the compensation policy for directors or the senior management of the corporation, although certain aspects of executive compensation may be subject to stockholder vote due to the provisions of U.S. federal securities and tax law, as well as exchange requirements.
AMERICAN DEPOSITARY SHARES
Depositary
JPMorgan Chase Bank, N.A., as depositary, has agreed to act as the depositary and registrar for the ADSs representing our ordinary shares. The depositary’s office is located at 383 Madison Avenue, Floor 11, New York, NY 10179.
Provisions
The following is a summary of what we believe to be the material terms of the deposit agreement. Notwithstanding this, because it is a summary, it may not contain all the information that you may otherwise deem important. For more complete information, you should read the entire deposit agreement and the form of ADR which contains the terms of your ADSs. The deposit agreement has been filed with the SEC as an exhibit to the Annual Report on 20-F of which this Exhibit is a part.
Each ADS will represent an ownership interest in a designated number of ordinary shares in our capital which will be deposited from time to time with the custodian, as agent of the depositary, under the deposit agreement among ourselves, the depositary, yourself as an ADR holder and all other ADR holders, and all beneficial owners of an interest in the ADSs evidenced by ADRs from time to time.
The share-to-ADS ratio is ten to one, subject to amendment as provided in the form of ADR (which may give rise to fees contemplated by the form of ADR). In the future, each ADS will also represent any securities, cash or other property deposited with the depositary but which they have not distributed directly to you.
A beneficial owner is any person or entity having a beneficial ownership interest ADSs. A beneficial owner needs not be the holder of the ADR evidencing such ADS. If a beneficial owner of ADSs is not an ADR holder, it must rely on the holder of the ADR(s) evidencing such ADSs in order to assert any rights or receive any benefits under the deposit agreement. A beneficial owner shall only be able to exercise any right or receive any benefit under the deposit agreement solely through the holder of the ADR(s) evidencing the ADSs owned by such beneficial owner. The arrangements between a beneficial owner of ADSs and the holder of the corresponding ADRs may affect the beneficial owner’s ability to exercise any rights it may have.
An ADR holder shall be deemed to have all requisite authority to act on behalf of any and all beneficial owners of the ADSs evidenced by the ADRs registered in such ADR holder’s name for all purposes under the deposit agreement and ADRs. The depositary’s only notification obligations under the deposit agreement and the ADRs is to registered ADR holders. Notice to an ADR holder shall be deemed, for all purposes of the deposit agreement and the ADRs, to constitute notice to any and all beneficial owners of the ADSs evidenced by such ADR holder’s ADRs.
Unless certificated ADRs are specifically requested, all ADSs will be issued on the books of our depositary in book-entry form and periodic statements will be mailed to you which reflect your ownership interest in such ADSs. In our description, references to American Depositary Receipts (“ADRs”) shall include the statements you will receive which reflect your ownership of ADSs. Each certificated ADR shall be registered in the name of the holder; no bearer certificates shall be issued for ADRs.
You may hold ADSs either directly or indirectly through your broker or other financial institution. If you hold ADSs directly, by having an ADS registered in your name on the books of the depositary, you are an ADR holder. This description assumes you hold your ADSs directly. If you hold the ADSs through your broker or financial institution nominee, you must rely on the procedures of such broker or financial institution to assert the rights of an ADR holder described in this section. You should consult with your broker or financial institution to find out what those procedures are.
As an ADR holder or beneficial owner, we will not treat you as a shareholder of ours and you will not have any shareholder rights. Dutch law governs shareholder rights. Because the depositary or its nominee will be the shareholder of record for the shares represented by all outstanding ADSs, shareholder rights rest with such record holder. Your rights are those of an ADR holder or of a beneficial owner. Such rights derive from the terms of the deposit agreement to be entered into among us, the depositary and all holders and beneficial owners from time to time of ADRs issued under the deposit agreement and, in the case of a beneficial owner, from the arrangements between the beneficial owner and the holder of the corresponding ADRs. The obligations of the depositary and its agents are also set out in the deposit agreement. Because the depositary or its nominee will actually be the registered owner of the shares, you must rely on it to exercise the rights of a shareholder on your behalf. Because an ADR has similarities to a depository receipt as such term is known under Dutch law, we consider the holders of ADRs to be holders of depository receipts under Dutch law issued with our cooperation. As a consequence, holders of ADRs shall have certain rights under Dutch law, including meeting rights with respect to our general meetings and the rights of those having such meeting rights as described under “Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934—Ordinary Shares”.
Share Dividends and Other Distributions
How will I receive dividends and other distributions on the shares underlying my ADSs?
We may make various types of distributions with respect to our securities. The depositary has agreed that, to the extent practicable, it will pay to you the cash dividends or other distributions it or the custodian receives on shares or other deposited securities, after converting any cash received into U.S. dollars (if it determines such conversion may be made on a reasonable basis) and, in all cases, making any necessary deductions provided for in the deposit agreement. The depositary may utilize a division, branch or affiliate of JPMorgan to direct, manage and/or execute any public and/or private sale of securities under the deposit agreement. Such division, branch and/or affiliate may charge the depositary a fee in connection with such sales, which fee is considered an expense of the depositary. You will receive these distributions in proportion to the number of underlying securities that your ADSs represent.
Except as stated below, the depositary will deliver such distributions to ADR holders in proportion to their interests in the following manner:
•Cash. The depositary will distribute any U.S. dollars available to it resulting from a cash dividend or other cash distribution or the net proceeds of sales of any other distribution or portion thereof (to the extent applicable), on an averaged or other practicable basis, subject to (i) appropriate adjustments for taxes withheld, (ii) such distribution being impermissible or impracticable with respect to certain registered ADR holders, and (iii) deduction of the depositary’s and/or its agents’ expenses in
(1) converting any foreign currency to U.S. dollars to the extent that it determines that such conversion may be made on a reasonable basis, (2) transferring foreign currency or U.S. dollars to the United States by such means as the depositary may determine to the extent that it determines that such transfer may be made on a reasonable basis, (3) obtaining any approval or license of any governmental authority required for such conversion or transfer, which is obtainable at a reasonable cost and within a reasonable time and (4) making any sale by public or private means in any commercially reasonable manner. If exchange rates fluctuate during a time when the depositary cannot convert a foreign currency, you may lose some or all of the value of the distribution.
•Shares. In the case of a distribution in shares, the depositary will issue additional ADRs to evidence the number of ADSs representing such shares. Only whole ADSs will be issued. Any shares which would result in fractional ADSs will be sold and the net proceeds will be distributed in the same manner as cash to the ADR holders entitled thereto.
•Rights to receive additional shares. In the case of a distribution of rights to subscribe for additional shares or other rights, if we timely provide evidence satisfactory to the depositary that it may lawfully distribute such rights, the depositary will distribute warrants or other instruments in the discretion of the depositary representing such rights. However, if we do not timely furnish such evidence, the depositary may:
(i)sell such rights if practicable and distribute the net proceeds in the same manner as cash to the ADR holders entitled thereto; or
(ii)if it is not practicable to sell such rights by reason of the non-transferability of the rights, limited markets therefor, their short duration or otherwise, do nothing and allow such rights to lapse, in which case ADR holders will receive nothing and the rights may lapse.
•Other Distributions. In the case of a distribution of securities or property other than those described above, the depositary may either (i) distribute such securities or property in any manner it deems
equitable and practicable or (ii) to the extent the depositary deems distribution of such securities or property not to be equitable and practicable, sell such securities or property and distribute any net proceeds in the same way it distributes cash.
If the depositary determines in its discretion that any distribution described above is not practicable with respect to any specific registered ADR holder, the depositary may choose any method of distribution that it deems practicable for such ADR holder, including the distribution of foreign currency, securities or property, or it may retain such items, without paying interest on or investing them, on behalf of the ADR holder as deposited securities, in which case the ADSs will also represent the retained items.
Any U.S. dollars will be distributed by checks drawn on a bank in the United States for whole dollars and cents. Fractional cents will be withheld without liability and dealt with by the depositary in accordance with its then current practices.
The depositary is not responsible if it fails to determine that any distribution or action is lawful or reasonably practicable.
There can be no assurance that the depositary will be able to convert any currency at a specified exchange rate or sell any property, rights, shares or other securities at a specified price, nor that any of such transactions can be completed within a specified time period. All purchases and sales of securities will be handled by the depositary in accordance with its then current policies, which are currently set forth on the Disclosure page (or successor page) of www.adr.com the location and contents of which the depositary shall be solely responsible for.
Deposit, Withdrawal and Cancellation
How does the depositary issue ADSs?
The depositary will issue ADSs if you or your broker deposit shares or evidence of rights to receive shares with the custodian and pay the fees and expenses owing to the depositary in connection with such issuance.
Shares deposited in the future with the custodian must be accompanied by certain delivery documentation and shall, at the time of such deposit, be registered in the name of JPMorgan (or nominee), as depositary for the benefit of holders of ADRs or in such other name as the depositary shall direct.
The custodian will hold all deposited shares for the account and to the order of the depositary, in each case for the benefit of ADR holders. ADR holders and beneficial owners thus have no direct ownership interest in the shares and only have such rights as are contained in the deposit agreement and, for ADR holders, certain rights attributed under Dutch law to holders of depository receipts for ordinary shares in our capital issued with our cooperation. The custodian will also hold any additional securities, property and cash received on or in substitution for the deposited shares. The deposited shares and any such additional items are referred to as “deposited securities.”
Deposited securities are not intended to, and shall not, constitute proprietary assets of the depositary, the custodian or their nominees. Beneficial ownership in deposited securities is intended to be, and shall at all times during the term of the deposit agreement continue to be, vested in the beneficial owners of the ADSs representing such deposited securities. Notwithstanding anything else contained herein, in the deposit agreement, in the form of ADR and/or in any outstanding ADSs, the depositary, the custodian and their respective nominees are intended to be, and shall at all times during the term of the deposit agreement be, the record holder(s) only of the deposited securities represented by the ADSs for the benefit of the ADR holders.
The depositary, on its own behalf and on behalf of the custodian and their respective nominees, disclaims any beneficial ownership interest in the deposited securities held on behalf of the ADR holders.
Upon each deposit of shares, receipt of related delivery documentation and compliance with the other provisions of the deposit agreement, including the payment of the fees and charges of the depositary and any taxes or other fees or charges owing, the depositary will issue an ADR or ADRs in the name or upon the order of the person entitled thereto evidencing the number of ADSs to which such person is entitled. All of the ADSs issued will, unless specifically requested to the contrary, be part of the depositary’s direct registration system, and a registered holder will receive periodic statements from the depositary which will show the number of ADSs registered in such holder’s name. An ADR holder can request that the ADSs not be held through the depositary’s direct registration system and that a certificated ADR be issued.
How do ADR holders cancel an ADS and obtain deposited securities?
When you turn in your ADR certificate at the depositary’s office, or when you provide proper instructions and documentation in the case of direct registration ADSs, the depositary will, upon payment of certain applicable fees, charges and taxes, deliver the underlying shares to you or upon your written order. Delivery of deposited securities in certificated form will be made at the custodian’s office. At your risk, expense and request, the depositary may deliver deposited securities at such other place as you may request.
The depositary may only restrict the withdrawal of deposited securities in connection with:
•temporary delays caused by closing our transfer books or those of the depositary or the payment of dividends;
•the payment of fees, taxes and similar charges; or
•compliance with any U.S. or foreign laws or governmental regulations relating to the ADRs or to the withdrawal of deposited securities.
This right of withdrawal may not be limited by any other provision of the deposit agreement.
Record Dates
The depositary may, after consultation with us if practicable, fix a record date (which, to the extent applicable, shall be as near as practicable to any corresponding record dates for general meetings set by us or by applicable law) for the determination of the registered ADR holders who will be entitled (or obligated, as the case may be):
•to receive any distribution on or in respect of deposited securities,
•to give instructions for the exercise of voting rights at a general meeting,
•to pay the fee assessed by the depositary for administration of the ADR program and for any expenses as provided for in the ADR, or
•to receive any notice or to act in respect of other matters, all subject to
the provisions of the deposit agreement.
Voting Rights
How do I vote?
If you are an ADR holder and the depositary asks you to provide it with voting instructions, you may instruct the depositary how to exercise the voting rights for the shares which underlie your ADSs. As soon as practicable after receipt from us of notice of any general meeting, or of our solicitation of consents or proxies from holders of shares, the depositary shall fix the ADS record date in accordance with the provisions of the deposit agreement, provided that if the depositary receives a written request from us in a timely manner and at least 30 days prior to the date of such vote or meeting, the depositary shall, at our expense, distribute to the registered ADR holders a “voting notice” stating (i) final information particular to such vote and meeting and any solicitation materials, (ii) that each ADR holder on the record date set by the depositary will, subject to any applicable provisions of Dutch law, be entitled to instruct the depositary as to the exercise of the voting rights, if any, pertaining to the deposited securities represented by the ADSs evidenced by such ADR holder’s ADRs and (iii) the manner in which such instructions may be given, or deemed to be given pursuant to the terms of the deposit agreement, including instructions for giving a discretionary proxy to a person designated by us. Each ADR holder shall be solely responsible for the forwarding of voting notices to the beneficial owners of ADSs registered in such ADR holder’s name. There is no guarantee that ADR holders and beneficial owners generally or any holder or beneficial owner in particular will receive the notice described above with sufficient time to enable such ADR holder or beneficial owner to return any voting instructions to the depositary in a timely manner.
Following actual receipt by the ADR department responsible for proxies and voting of ADR holders’ instructions (including, without limitation, instructions of any entity or entities acting on behalf of the nominee for DTC), the depositary shall, in the manner and on or before the time established by the depositary for such purpose, endeavor to vote or cause to be voted the deposited securities represented by the ADSs evidenced by such ADR holders’ ADRs in accordance with such instructions insofar as practicable and permitted under the provisions of or governing deposited securities.
To the extent that (A) we have provided the depositary with at least 35 days’ notice of the proposed meeting, (B) the voting notice will be received by all ADR holders and beneficial owners no less than 10 days prior to the date of the meeting and/or the cut-off date for the solicitation of consents or proxies, and (C) the depositary does not receive instructions on a particular agenda item from an ADR holder (including, without limitation, any entity or entities acting on behalf of the nominee for DTC) in a timely manner, such ADR holder shall be deemed, and in the deposit agreement the depositary is instructed to deem such ADR holder, to have instructed the depositary to give a discretionary proxy for such agenda item(s) to a person designated by us to vote the deposited securities represented by the ADSs for which actual instructions were not so given by all such ADR holders on such agenda item(s), provided that no such instruction shall be deemed given and no discretionary proxy shall be given unless (1) we inform the depositary in writing (and we agree to provide the depositary with such instruction promptly in writing) that (a) we wish such proxy to be given with respect to such agenda item(s), (b) there is no substantial opposition existing with respect to such agenda item(s) and (c) such agenda item(s), if approved, would not materially or adversely affect the rights of holders of shares, and (2) the depositary has obtained an opinion of counsel, in form and substance satisfactory to the depositary, confirming that (i) the granting of such discretionary proxy does not subject the Depositary to any reporting obligations in the Netherlands, (ii) the granting of such proxy will not result in a violation of Dutch laws, rules, regulations or permits, (iii) the voting arrangement and deemed instruction as contemplated herein will be given effect under Dutch laws, rules and regulations, and (iv) the granting of such discretionary proxy will not under any circumstances result in the shares represented by the ADSs being treated as assets of the depositary under Dutch laws, rules or regulations.
The depositary may from time to time access information available to it to consider whether any of the circumstances described above exist, or request additional information from us in respect thereto. By taking any such action, the depositary shall not in any way be deemed or inferred to have been required, or have had any duty or responsibility (contractual or otherwise), to monitor or inquire whether any of the circumstances described above existed.
In addition to the limitations provided for in the deposit agreement, ADR holders and beneficial owners are advised and agree that (a) the depositary will rely fully and exclusively on us to inform it of any of the circumstances set forth above, and (b) neither the depositary, the custodian nor any of their respective agents shall be obliged to inquire or investigate whether any of the circumstances described above exist and/or whether we complied with our obligation to timely inform the depositary of such circumstances. Neither the depositary, the custodian nor any of their respective agents shall incur any liability to ADR holders or beneficial owners (i) as a result of our failure to determine that any of the circumstances described above exist or our failure to timely notify the depositary of any such circumstances or (ii) if any agenda item which is approved at a meeting has, or is claimed to have, a material or adverse effect on the rights of holders of shares. Because there is no guarantee that ADR holders and beneficial owners will receive the notices described above with sufficient time to enable such ADR holders or beneficial owners to return any voting instructions to the depositary in a timely manner, ADR holders and beneficial owners may be deemed to have instructed the depositary to give a discretionary proxy to a person designated by us in such circumstances, and neither the depositary, the custodian nor any of their respective agents shall incur any liability to ADR holders or beneficial owners in such circumstances.
ADR holders are strongly encouraged to forward their voting instructions to the depositary as soon as possible. For instructions to be valid, the ADR department of the depositary that is responsible for proxies and voting must receive them in the manner and on or before the time specified, notwithstanding that such instructions may have been physically received by the depositary prior to such time. The depositary will not itself exercise any voting discretion in respect of deposited securities. The depositary and its agents will not be responsible for any failure to carry out any instructions to vote any of the deposited securities, for the manner in which any voting instructions are given, or deemed to be given pursuant to the terms of the deposit agreement, including instructions to give a discretionary proxy to a person designated by us, for the manner in which any vote is cast, including, without limitation, any vote cast by a person to whom the depositary is instructed to grant a discretionary proxy (or deemed to have been instructed pursuant to the terms of the deposit agreement), or for the effect of any such vote. Notwithstanding anything contained in the deposit agreement or any ADR, the depositary may, to the extent not prohibited by any law, regulation, or requirement of the stock exchange on which the ADSs are listed, in lieu of distribution of the materials provided to the depositary in connection with any meeting of or solicitation of consents or proxies from holders of deposited securities, distribute to the registered holders of ADRs a notice that provides such ADR holders with or otherwise publicizes to such ADR holders instructions on how to retrieve such materials or receive such materials upon request (i.e., by reference to a website containing the materials for retrieval or a contact for requesting copies of the materials).
Under Dutch law and our articles of association, each as in effect as of the date of the deposit agreement, the voting procedure at any general meeting shall be determined by the chairperson of the meeting.
There is no guarantee that you will receive voting materials in time to instruct the depositary to vote and it is possible that you, or persons who hold their ADSs through brokers, dealers or other third parties, will not have the opportunity to exercise a right to vote.
Reports and Other Communications
Will ADR holders be able to view our reports?
The depositary will make available for inspection by ADR holders at the offices of the depositary and the custodian the deposit agreement, the provisions of or governing deposited securities, and any written communications from us which are both received by the custodian or its nominee as a holder of deposited securities and made generally available to the holders of deposited securities.
Additionally, if we make any written communications generally available to holders of our shares, and we furnish copies thereof (or English translations or summaries) to the depositary, it will distribute the same to registered ADR holders.
Fees and Expenses
What fees and expenses will I be responsible for paying?
The depositary may charge each person to whom ADSs are issued, including, without limitation, issuances against deposits of shares, issuances in respect of share distributions, rights and other distributions, issuances pursuant to a stock dividend or stock split declared by us or issuances pursuant to a merger, exchange of securities or any other transaction or event affecting the ADSs or deposited securities, and each person surrendering ADSs for withdrawal of deposited securities or whose ADRs are cancelled or reduced for any other reason, $5.00 for each 100 ADSs (or any portion thereof) issued, delivered, reduced, canceled or surrendered, or upon which a share distribution or elective distribution is made or offered, as the case may be. The depositary may sell (by public or private sale) sufficient securities and property received in respect of a share distribution, rights and/or other distribution prior to such deposit to pay such charge.
The following additional charges shall also be incurred by the ADR holders, the beneficial owners, by any party depositing or withdrawing shares or by any party surrendering ADSs and/or to whom ADSs are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by us or an exchange of stock regarding the ADSs or the deposited securities or a distribution of ADSs), whichever is applicable:
•a fee of $0.05 or less per ADS held for any cash distribution made, or for any elective cash/stock dividend offered, pursuant to the deposit agreement;
•an aggregate fee of $0.05 or less per ADS per calendar year (or portion thereof) for services performed by the depositary in administering the ADRs (which fee may be charged on a periodic basis during each calendar year and shall be assessed against holders of ADRs as of the record date or record dates set by the depositary during each calendar year and shall be payable in the manner described in the next succeeding provision);
•a fee for the reimbursement of such fees, charges and expenses as are incurred by the depositary and/or any of its agents (including, without limitation, the custodian and expenses incurred on behalf of ADR holders in connection with compliance with foreign exchange control regulations or any law or regulation relating to foreign investment) in connection with the servicing of the shares or other deposited securities, the sale of securities (including, without limitation, deposited securities), the delivery of deposited securities or otherwise in connection with the depositary’s or its custodian’s compliance with applicable law, rule or regulation (which fees and charges shall be assessed on a proportionate basis against ADR holders as of the record date or dates set by the depositary and shall be payable at the sole discretion of the depositary by billing such ADR holders or by deducting such charge from one or more cash dividends or other cash distributions);
•a fee for the distribution of securities (or the sale of securities in connection with a distribution), such fee being in an amount equal to the $0.05 per ADS issuance fee for the execution and delivery of ADSs which would have been charged as a result of the deposit of such securities (treating all such securities as if they were shares) but which securities or the net cash proceeds from the sale thereof are instead distributed by the depositary to those ADR holders entitled thereto;
•stock transfer or other taxes and other governmental charges;
•cable, telex and facsimile transmission and delivery charges incurred at your request in connection with the deposit or delivery of shares, ADRs or deposited securities;
•transfer or registration fees for the registration of transfer of deposited securities on any applicable register in connection with the deposit or withdrawal of deposited securities; and
•fees of any division, branch or affiliate of the depositary utilized by the depositary to direct, manage and/or execute any public and/or private sale of securities under the deposit agreement. To facilitate the administration of various depositary receipt transactions, including disbursement of dividends or other cash distributions and other corporate actions, the depositary may engage the foreign exchange desk within JPMorgan and/or its affiliates in order to enter into spot foreign exchange transactions to convert foreign currency into U.S. dollars. For certain currencies, foreign exchange transactions are entered into with the Bank or an affiliate, as the case may be, acting in a principal capacity. For other currencies, foreign exchange transactions are routed directly to and managed by an unaffiliated local custodian (or other third party local liquidity provider), and neither the Bank nor any of its affiliates is a party to such foreign exchange transactions.
The foreign exchange rate applied to a foreign exchange transaction will be either (a) a published benchmark rate, or (b) a rate determined by a third party local liquidity provider, in each case plus or minus a spread, as applicable. The depositary will disclose which foreign exchange rate and spread, if any, apply to such currency on the “Disclosure” page (or successor page) of www.adr.com. Such applicable foreign exchange rate and spread may (and neither the depositary, the Bank nor any of their affiliates is under any obligation to ensure that such rate does not) differ from rates and spreads at which comparable transactions are entered into with other customers or the range of foreign exchange rates and spreads at which the Bank or any of its affiliates enters into foreign exchange transactions in the relevant currency pair on the date of the foreign exchange transaction.
Additionally, the timing of execution of an foreign exchange transaction varies according to local market dynamics, which may include regulatory requirements, market hours and liquidity in the foreign exchange market or other factors. Furthermore, the Bank and its affiliates may manage the associated risks of their position in the market in a manner they deem appropriate without regard to the impact of such activities on the depositary, us, holders or beneficial owners. The spread applied does not reflect any gains or losses that may be earned or incurred by the Bank and its affiliates as a result of risk management or other hedging related activity.
Notwithstanding the foregoing, to the extent we provide U.S. dollars to the depositary, neither the Bank nor any of its affiliates will execute a foreign exchange transaction as set forth herein. In such case, the depositary will distribute the U.S. dollars received from us.
Further details relating to the applicable foreign exchange rate, the applicable spread and the execution of foreign exchange transactions will be provided by the depositary on www.adr.com. Each holder and beneficial owner by holding or owning an ADR or ADS or an interest therein, and we, each acknowledge and agree that the terms applicable to foreign exchange transactions disclosed from time to time on www.adr.com will apply to any foreign exchange transaction executed pursuant to the deposit agreement.
We will pay all other charges and expenses of the depositary and any agent of the depositary (except the custodian) pursuant to agreements from time to time between us and the depositary.
The right of the depositary to receive payment of fees, charges and expenses survives the termination of the deposit agreement, and shall extend for those fees, charges and expenses incurred prior to the effectiveness of any resignation or removal of the depositary.
The fees and charges described above may be amended from time to time by agreement between us and the depositary.
The depositary may make available to us a set amount or a portion of the depositary fees charged in respect of the ADR program or otherwise upon such terms and conditions as we and the depositary may agree from time to time. The depositary collects its fees for issuance and cancellation of ADSs directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions, or by directly billing investors, or by charging the book-entry system accounts of participants acting for them. The depositary will generally set off the amounts owing from distributions made to holders of ADSs. If, however, no distribution exists and payment owing is not timely received by the depositary, the depositary may refuse to provide any further services to ADR holders that have not paid those fees and expenses owing until such fees and expenses have been paid. At the discretion of the depositary, all fees and charges owing under the deposit agreement are due in advance and/or when declared owing by the depositary.
Payment of Taxes
ADR holders or beneficial owners must pay any tax or other governmental charge payable by the custodian or the depositary on any ADS or ADR, deposited security or distribution. If any taxes or other governmental charges (including any penalties and/or interest) shall become payable by or on behalf of the custodian or the depositary with respect to any ADR, any deposited securities represented by the ADSs evidenced thereby or any distribution thereon, including, without limitation, any Chinese Enterprise Income Tax owing if the SAT Circular 82 issued by the SAT or any other circular, edict, order or ruling, as issued and as from time to time amended, is applied or otherwise, such tax or other governmental charge shall be paid by the ADR holder thereof to the depositary and by holding or owning, or having held or owned, an ADR or any ADSs evidenced thereby, the ADR holder and all beneficial owners thereof, and all prior ADR holders and beneficial owners thereof, jointly and severally, agree to indemnify, defend and save harmless each of the depositary and its agents in respect of such tax or other governmental charge. Notwithstanding the depositary’s right to seek payment from current and former beneficial owners, by holding or owning, or having held or owned, an ADR, the ADR holder thereof (and prior ADR holder thereof) acknowledges and agrees that the depositary has no obligation to seek payment of amounts owing from any current or former beneficial owner. If an ADR holder owes any tax or other governmental charge, the depositary may (i) deduct the amount thereof from any cash distributions, or (ii) sell deposited securities (by public or private sale) and deduct the amount owing from the net proceeds of such sale. In either case the ADR holder remains liable for any shortfall. If any tax or governmental charge is unpaid, the depositary may also refuse to effect any registration, registration of transfer, split-up or combination of deposited securities or withdrawal of deposited securities until such payment is made. If any tax or governmental charge is required to be withheld on any cash distribution, the depositary may deduct the amount required to be withheld from any cash distribution or, in the case of a non-cash distribution, sell the distributed property or securities (by public or private sale) in such amounts and in such manner as the depositary deems necessary and practicable to pay such taxes and distribute any remaining net proceeds or the balance of any such property after deduction of such taxes to the ADR holders entitled thereto.
As an ADR holder or beneficial owner, you will be agreeing to indemnify us, the depositary, its custodian and any of our or their respective officers, directors, employees, agents and affiliates against, and hold each of them harmless from, any claims by any governmental authority with respect to taxes, additions to tax, penalties or interest arising out of any refund of taxes, reduced rate of withholding at source or other tax benefit obtained.
Reclassifications, Recapitalizations and Mergers
If we take certain actions that affect the deposited securities, including (i) any change in par value, split-up, consolidation, cancellation or other reclassification of deposited securities or (ii) any distributions of shares or other property not made to holders of ADRs or (iii) any recapitalization, reorganization, merger, consolidation, liquidation, receivership, bankruptcy or sale of all or substantially all of our assets, then the depositary may choose to, and shall if reasonably requested by us:
•amend the form of ADR;
•distribute additional or amended ADRs;
•distribute cash, securities or other property it has received in connection with such actions;
•sell any securities or property received and distribute the proceeds as cash; or
•none of the above.
If the depositary does not choose any of the above options, any of the cash, securities or other property it receives will constitute part of the deposited securities and each ADS will then represent a proportionate interest in such property.
Amendment and Termination
How may the deposit agreement be amended?
We may agree with the depositary to amend the deposit agreement and the ADSs without your consent for any reason. ADR holders must be given at least 30 days’ notice of any amendment that imposes or increases any fees on a per ADS basis or charges (other than stock transfer or other taxes and other governmental charges, transfer or registration fees, SWIFT, cable, telex or facsimile transmission costs, delivery costs or other such expenses), or otherwise prejudices any substantial existing right of ADR holders or beneficial owners. Such notice need not describe in detail the specific amendments effectuated thereby, but must identify to ADR holders and beneficial owners a means to access the text of such amendment. If an ADR holder continues to hold an ADR or ADRs after being so notified, such ADR holder and any beneficial owner are deemed to agree to such amendment and to be bound by the deposit agreement as so amended. No amendment, however, will impair your right to surrender your ADSs and receive the underlying securities, except in order to comply with mandatory provisions of applicable law.
Any amendments or supplements which (i) are reasonably necessary (as agreed by us and the depositary) in order for (a) the ADSs to be registered on Form F-6 under the Securities Act of 1933 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 ADR holders, shall be deemed not to prejudice any substantial rights of ADR holders or beneficial owners.
Notwithstanding the foregoing, if any governmental body or regulatory body should adopt new laws, rules or regulations which would require amendment or supplement of the deposit agreement or the form of ADR to ensure compliance therewith, we and the depositary may amend or supplement the deposit agreement and the ADR 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 ADR holders or within any other period of time as required for compliance.
Notice of any amendment to the deposit agreement or form of ADRs 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 ADR holders identifies a means for ADR holders and beneficial owners to retrieve or receive the text of such amendment (i.e., upon retrieval from the SEC’s, the depositary’s or our website or upon request from the depositary).
How may the deposit agreement be terminated?
The depositary may, and shall at our written direction, terminate the deposit agreement and the ADRs by mailing notice of such termination to the registered holders of ADRs at least 30 days prior to the date fixed in such notice for such termination; provided, however, if the depositary shall have (i) resigned as depositary under the deposit agreement, notice of such termination by the depositary shall not be provided to registered ADR holders unless a successor depositary shall not be operating under the deposit agreement within 60 days of the date of such resignation, and (ii) been removed as depositary under the deposit agreement, notice of such termination by the depositary shall not be provided to registered holders of ADRs unless a successor depositary shall not be operating under the deposit agreement on the 60th day after our notice of removal was first provided to the depositary.
After the date so fixed for termination, the depositary and its agents will perform no further acts under the deposit agreement and the ADRs, except to receive and hold (or sell) distributions on deposited securities and deliver deposited securities being withdrawn. As soon as practicable after the date so fixed for termination, the depositary shall use its reasonable efforts to sell the deposited securities and shall thereafter (as long as it may lawfully do so) hold in an account (which may be a segregated or unsegregated account) the net proceeds of such sales, together with any other cash then held by it under the deposit agreement, without liability for interest, in trust for the pro rata benefit of the holders of ADRs not theretofore surrendered. After making such sale, the depositary shall be discharged from all obligations in respect of the deposit agreement and the ADRs, except to account for such net proceeds and other cash. After the date so fixed for termination, the company shall be discharged from all obligations under the deposit agreement except for its obligations to the depositary and its agents.
Notwithstanding anything to the contrary, in connection with any such termination, the depositary may, in its sole discretion and without notice to us, establish an unsponsored American depositary share program (on such terms as the depositary may determine) for our shares and make available to ADR holders a means to withdraw the shares represented by the ADSs issued under the deposit agreement and to direct the deposit of such shares into such unsponsored American depositary share program, subject, in each case, to receipt by the depositary, at its discretion, of the fees, charges and expenses provided for under the deposit agreement and the fees, charges and expenses applicable to the unsponsored American depositary share program.
Limitations on Obligations and Liability to ADR holders
Limits on our obligations and the obligations of the depositary; limits on liability to ADR holders and holders of ADSs
Prior to the issue, registration, registration of transfer, split-up, combination, or cancellation of any ADRs, or the delivery of any distribution in respect thereof, and from time to time in the case of the production of proofs as described below, we or the depositary or its custodian may require:
•payment with respect thereto of (i) any stock transfer or other tax or other governmental charge, (ii) any stock transfer or registration fees in effect for the registration of transfers of shares or other deposited securities upon any applicable register and (iii) any applicable fees and expenses described in the deposit agreement;
•the production of proof satisfactory to it of (i) the identity of any signatory and genuineness of any signature and (ii) such other information, including without limitation, information as to citizenship, residence, exchange control approval, beneficial or other ownership of, or interest in, any securities, compliance with applicable law, regulations, provisions of or governing deposited securities and terms of the deposit agreement and the ADRs, as it may deem necessary or proper; and
•compliance with such regulations as the depositary may establish consistent with the deposit agreement.
The issuance of ADRs, the acceptance of deposits of shares, the registration, registration of transfer, split-up or combination of ADRs or the withdrawal of shares, may be suspended, generally or in particular instances, when the ADR register or any register for deposited securities is closed or when any such action is deemed advisable by the depositary; provided that the ability to withdraw shares may only be limited under the following circumstances: (i) temporary delays caused by closing transfer books of the depositary or our transfer books or the deposit of shares in connection with voting at a shareholders’ meeting, or the payment of dividends, (ii) the payment of fees, taxes, and similar charges, and (iii) compliance with any laws or governmental regulations relating to ADRs or to the withdrawal of deposited securities.
The deposit agreement expressly limits the obligations and liability of the depositary, ourselves and our respective agents, provided, however, that no disclaimer of liability under the Securities Act of 1933 is intended by any of the limitations of liabilities provisions of the deposit agreement. The deposit agreement provides that each of us, the depositary and our respective agents will:
•incur or assume no liability (including, without limitation, to holders or beneficial owners) if any present or future law, rule, regulation, fiat, order or decree of the Netherlands, the United States or any other country or jurisdiction, or of any governmental or regulatory authority or securities exchange or market or automated quotation system, the provisions of or governing any deposited securities, any present or future provision of our charter, any act of God, war, terrorism, nationalization, epidemic, pandemic, expropriation, currency restrictions, work stoppage, strike, civil unrest, revolutions, rebellions, explosions, computer failure or circumstance beyond our, the depositary’s or our respective agents’ direct and immediate control shall prevent or delay, or shall cause any of them to be subject to any civil or criminal penalty in connection with, any act which the deposit agreement or the ADRs provide shall be done or performed by us, the depositary or our respective agents (including, without limitation, voting);
•incur or assume no liability (including, without limitation, to holders or beneficial owners) by reason of any non-performance or delay, caused as aforesaid, in the performance of any act or things which by the terms of the deposit agreement it is provided shall or may be done or performed or any exercise or failure to exercise discretion under the deposit agreement or the ADRs including, without limitation, any failure to determine that any distribution or action may be lawful or reasonably practicable;
•incur or assume no liability (including, without limitation, to holders or beneficial owners) if it performs its obligations under the deposit agreement and ADRs without gross negligence or willful misconduct and the depositary shall not be a fiduciary or have any fiduciary duty to holders or beneficial owners;
•in the case of the depositary and its agents, be under no obligation to appear in, prosecute or defend any action, suit or other proceeding in respect of any deposited securities the ADSs or the ADRs;
•in the case of us and our agents, be under no obligation to appear in, prosecute or defend any action, suit or other proceeding in respect of any deposited securities the ADSs or the ADRs, which in our or our agents’ opinion, as the case may be, may involve it in expense or liability, unless indemnity satisfactory to us or our agent, as the case may be against all expense (including fees and disbursements of counsel) and liability be furnished as often as may be requested;
•not be liable (including, without limitation, to holders or beneficial owners) for any action or inaction by it in reliance upon the advice of or information from any legal counsel, any accountant, any person presenting shares for deposit, any registered holder of ADRs, or any other person believed by it to be competent to give such advice or information and/or, in the case of the depositary, us; or
•may rely and shall be protected in acting upon any written notice, request, direction, instruction or document believed by it to be genuine and to have been signed, presented or given by the proper party or parties.
The depositary and its agents may fully respond to any and all demands or requests for information maintained by or on its behalf in connection with the deposit agreement, any registered holder or holders of ADRs, any ADRs or otherwise related to the deposit agreement or ADRs to the extent such information is requested or required by or pursuant to any lawful authority, including without limitation laws, rules, regulations, administrative or judicial process, banking, securities or other regulators. The depositary shall not be liable for the acts or omissions made by, or the insolvency of, any securities depository, clearing agency or settlement system. Furthermore, the depositary shall not be responsible for, and shall incur no liability in connection with or arising from, the insolvency of any custodian that is not a branch or affiliate of JPMorgan. Notwithstanding anything to the contrary contained in the deposit agreement or any ADRs, the depositary shall not be responsible for, and shall incur no liability in connection with or arising from, any act or omission to act on the part of the custodian except to the extent that any registered ADR holder has incurred liability directly as a result of the custodian having (i) committed fraud or willful misconduct in the provision of custodial services to the depositary or (ii) failed to use reasonable care in the provision of custodial services to the depositary as determined in accordance with the standards prevailing in the jurisdiction in which the custodian is located. The depositary and the custodian(s) may use third party delivery services and providers of information regarding matters such as, but not limited to, pricing, proxy voting, corporate actions, class action litigation and other services in connection with the ADRs and the deposit agreement, and use local agents to provide services such as, but not limited to, attendance at any meetings of security holders of issuers. Although the depositary and the custodian will use reasonable care (and cause their agents to use reasonable care) in the selection and retention of such third party providers and local agents, they will not be responsible for any errors or omissions made by them in providing the relevant information or services. The depositary shall not have any liability for the price received in connection with any sale of securities, the timing thereof or any delay in action or omission to act nor shall it be responsible for any error or delay in action, omission to act, default or negligence on the part of the party so retained in connection with any such sale or proposed sale.
The depositary has no obligation to inform ADR holders or beneficial owners about the requirements of the laws, rules or regulations or any changes therein or thereto of the Netherlands, the United States or any other country or jurisdiction or of any governmental or regulatory authority or any securities exchange or market or automated quotation system.
Additionally, none of us, the depositary or the custodian shall be liable for the failure by any registered holder of ADRs or beneficial owner therein to obtain the benefits of credits or refunds of non-U.S. tax paid against such ADR holder’s or beneficial owner’s income tax liability. The depositary is under no obligation to provide the ADR holders and beneficial owners, or any of them, with any information about our tax status. Neither we nor the depositary shall incur any liability for any tax or tax consequences that may be incurred by registered ADR holders or beneficial owners on account of their ownership or disposition of ADRs or ADSs.
Neither the depositary nor its agents will be responsible for any failure to carry out any instructions to vote any of the deposited securities, for the manner in which any voting instructions are given, or deemed to be given pursuant to the terms of the deposit agreement, including instructions to give a discretionary proxy to a person designated by us, for the manner in which any vote is cast, including, without limitation, any vote cast by a person to whom the depositary is instructed to grant a discretionary proxy (or deemed to have been instructed pursuant to the terms of the deposit agreement), or for the effect of any such vote. The depositary may rely upon instructions from us or our counsel in respect of any approval or license required for any currency conversion, transfer or distribution. The depositary shall not incur any liability for the content of any information submitted to it by us or on our behalf for distribution to ADR holders or for any inaccuracy of any translation thereof, for any investment risk associated with acquiring an interest in the deposited securities, for the validity or worth of the deposited securities, for the credit-worthiness of any third party, for allowing any rights to lapse upon the terms of the deposit agreement or for the failure or timeliness of any notice from us. The depositary shall not be liable for any acts or omissions made by a successor depositary whether in connection with a previous act or omission of the depositary or in connection with any matter arising wholly after the removal or resignation of the depositary. Neither the depositary nor any of its agents shall be liable for any indirect, special, punitive or consequential damages (including, without limitation, legal fees and expenses) or lost profits, in each case of any form incurred by any person or entity (including, without limitation holders or beneficial owners of ADRs and ADSs), whether or not foreseeable and regardless of the type of action in which such a claim may be brought.
The depositary and its agents may own and deal in any class of securities of our company and our affiliates and in ADRs.
Disclosure of Interest in ADSs
To the extent that the provisions of or governing any deposited securities may require disclosure of or impose limits on beneficial or other ownership of, or interest in, deposited securities, other shares and other securities and may provide for blocking transfer, voting or other rights to enforce such disclosure or limits, you as ADR holders or beneficial owners agree to comply with all such disclosure requirements and ownership limitations and to comply with any reasonable instructions we may provide in respect thereof.
Books of Depositary
The depositary or its agent maintains a register for the registration, registration of transfer, combination and split-up of ADRs, which register shall include the depositary’s direct registration system. Registered holders of ADRs may inspect such records at the depositary’s office at all reasonable times, but solely for the purpose of communicating with other ADR holders in the interest of the business of our company or a matter relating to the deposit agreement.
Such register may be closed at any time or from time to time, when deemed expedient by the depositary.
The depositary maintains facilities for the delivery and receipt of ADRs.
Appointment
In the deposit agreement, each registered holder of ADRs and each beneficial owner, upon acceptance of any ADSs or ADRs (or any interest in any of them) issued in accordance with the terms and conditions of the deposit agreement is deemed for all purposes to:
•be a party to and bound by the terms of the deposit agreement and the applicable ADR or ADRs,
•appoint the depositary its attorney-in-fact, with full power to delegate, to act on its behalf and to take any and all actions contemplated in the deposit agreement and the applicable ADR or ADRs, to adopt any and all procedures necessary to comply with applicable laws and to take such action as the depositary in its sole discretion may deem necessary or appropriate to carry out the purposes of the deposit agreement and the applicable ADR or ADRs, the taking of such actions to be the conclusive determinant of the necessity and appropriateness thereof; and
•acknowledge and agree that (i) nothing in the deposit agreement or any ADR shall give rise to a partnership or joint venture among the parties thereto, nor establish a fiduciary or similar relationship among such parties, (ii) the depositary, its divisions, branches and affiliates, and their respective agents, may from time to time be in the possession of non-public information about us, ADR holders, beneficial owners and/or their respective affiliates, (iii) the depositary and its divisions, branches and affiliates may at any time have multiple banking relationships with us, ADR holders, beneficial owners and/or the affiliates of any of them, (iv) the depositary and its divisions, branches and affiliates may, from time to time, be engaged in transactions in which parties adverse to us, ADR holders, beneficial owners and/or their respective affiliates may have interests, (v) nothing contained in the deposit agreement or any ADR(s) shall (A) preclude the depositary or any of its divisions, branches or affiliates from engaging in any such transactions or establishing or maintaining any such relationships, or (B) obligate the depositary or any of its divisions, branches or affiliates to disclose any such transactions or relationships or to account for any profit made or payment received in any such transactions or relationships, (vi) the depositary shall not be deemed to have knowledge of any information held by any branch, division or affiliate of the depositary and (vii) notice to an ADR holder shall be deemed, for all purposes of the deposit agreement and the ADRs, to constitute notice to any and all beneficial owners of the ADSs evidenced by such ADR holder’s ADRs. For all purposes under the deposit agreement and the ADRs, the ADR holders thereof shall be deemed to have all requisite authority to act on behalf of any and all beneficial owners of the ADSs evidenced by such ADRs.
Governing Law
The deposit agreement, the ADSs and the ADRs are governed by and construed in accordance with the internal laws of the State of New York. In the deposit agreement, we have submitted to the non-exclusive jurisdiction of the courts of the State of New York and appointed an agent for service of process on our behalf. Any action based on the deposit agreement, the ADSs, the ADRs or the transactions contemplated therein or thereby may also be instituted by the depositary against us in any competent court in the Netherlands, the United States and/or any other court of competent jurisdiction.
Under the deposit agreement, by holding or owning an ADR or ADS or an interest therein, ADR holders and beneficial owners each irrevocably agree that any legal suit, action or proceeding against or involving ADR holders or beneficial owners brought by us or the depositary, arising out of or based upon the deposit agreement, the ADSs, the ADRs or the transactions contemplated thereby, may only be instituted in a state or federal court in New York, New York.
Jury Trial Waiver
In the deposit agreement, each party thereto (including, for the avoidance of doubt, each holder and beneficial owner of, and/or holder of interests in, ADSs or ADRs) irrevocably waives, to the fullest extent permitted by applicable law, any right it may have to a trial by jury in any suit, action or proceeding against the depositary and/or us directly or indirectly arising out of or relating to the shares or other deposited securities, the ADSs or the ADRs, the deposit agreement or any transaction contemplated therein, or the breach thereof (whether based on contract, tort, common law or any other theory), including any claim under the U.S. federal securities laws.
EX-2
5
pharming-exhibit24_04apr.htm
EX-2.4 TRUST DEED
pharming-exhibit24_04apr
Exhibit 2.4 EXECUTION VERSION Dated 21 January 2020 PHARMING GROUP N.V. and BNY MELLON CORPORATE TRUSTEE SERVICES LIMITED TRUST DEED constituting €125,000,000 3.00 per cent. Convertible Bonds due 2025 Linklaters Ref: L-294613 Linklaters LLP i Table of Contents Contents Page 1 INTERPRETATION ................................................................................................... 1 2 AMOUNT OF THE ORIGINAL BONDS AND COVENANT TO PAY .......................... 7 3 FORM OF THE ORIGINAL BONDS .......................................................................... 8 4 STAMP DUTIES AND TAXES ................................................................................... 8 5 FURTHER ISSUES ................................................................................................... 9 6 APPLICATION OF MONEYS RECEIVED BY THE TRUSTEE .................................. 9 7 COVENANT TO COMPLY ....................................................................................... 10 8 CONVERSION ........................................................................................................ 11 9 COVENANTS RELATING TO CONVERSION ......................................................... 11 10 COVENANTS .......................................................................................................... 11 11 REMUNERATION AND INDEMNIFICATION OF THE TRUSTEE ........................... 14 12 PROVISIONS SUPPLEMENTAL TO THE TRUSTEE ACT 1925 AND THE TRUSTEE ACT 2000 ................................................................................................................ 15 13 TRUSTEE LIABILITY .............................................................................................. 22 14 ENFORCEMENT, WAIVER AND PROOF OF DEFAULT ........................................ 23 15 TRUSTEE NOT PRECLUDED FROM ENTERING INTO CONTRACTS ................. 24 16 MODIFICATION ...................................................................................................... 24 17 APPOINTMENT, RETIREMENT AND REMOVAL OF THE TRUSTEE .................... 24 18 CURRENCY INDEMNITY ........................................................................................ 25 19 COMMUNICATIONS ............................................................................................... 26 20 PURCHASE OR REDEMPTION BY THE ISSUER OF SHARES ............................ 27 21 GOVERNING LAW AND JURISDICTION ................................................................ 27 22 COUNTERPARTS ................................................................................................... 28 23 CONTRACTS (RIGHTS OF THIRD PARTIES) ACT 1999 ....................................... 28 24 POWER OF ATTORNEY......................................................................................... 28 ii SCHEDULE 1 TERMS AND CONDITIONS OF THE BONDS ............................................. 29 SCHEDULE 2 FORM OF ORIGINAL DEFINITIVE REGISTERED BOND ........................... 76 SCHEDULE 3 FORM OF ORIGINAL GLOBAL BOND ........................................................ 81 SCHEDULE 4 PROVISIONS FOR MEETINGS OF BONDHOLDERS ................................ 87 SCHEDULE 5 FORM OF DIRECTORS' CERTIFICATE ...................................................... 95 1 This Trust Deed is made on 21 January 2020 between: PHARMING GROUP N.V.. a public company with limited liability (naarnloze vennootschap) incorporated under the laws of the Netherlands, having its corporate seat (statutaire zetel) in Leiden, the Netherlands, and having its registered office at Darwinweg 24, 2333 CR Leiden, the Netherlands, and registered with the trade register of the Dutch chamber of commerce under number 28048592 (the "Issuer"); and BNY MELLON CORPORATE TRUSTEE SERVICES LIMITED whose registered office is at One Canada Square, London E14 5AL, United Kingdom (the "Trustee", which expression shall, where the context so admits, include all persons for the time being the trustee or trustees of this Trust Deed). Whereas: (A) The Issuer, incorporated with limited liability in the Netherlands, has authorised (i) the issue of €125,000,000 in principal amount of Bonds to be known as its 3.00 per cent. Convertible Bonds due 2025 to be constituted by this Trust Deed and (ii) the issue of Shares that may be issued on conversion of the Bonds. (B) The Trustee has agreed to act as trustee of this Trust Deed on the following terms and conditions. This Deed witnesses and it is declared as follows: 1 Interpretation 1.1 Definitions: The following expressions shall have the following meanings: "Agency Agreement" means, in relation to the Original Bonds, the Paying, Transfer and Conversion Agency Agreement dated on or about the date hereof, as altered from time to time, between the Issuer, the Trustee, the Principal Paying, Transfer and Conversion Agent, and the Registrar whereby the initial Principal Paying, Transfer and Conversion Agent and the Registrar were appointed in relation to the Original Bonds and includes any other agreements approved in writing by the Trustee (such approval not to be unreasonably withheld or delayed) and the Issuer appointing Successor Agents or amending or modifying any of such agreements; "Agents" means, in relation to the Original Bonds, the Principal Paying, Transfer and Conversion Agent and the Registrar and any other agent appointed pursuant to the Agency Agreement (and "Agent" means any one of them) and, in relation to any Further Bonds, means any agent or registrar appointed in relation to them; "Applicable Law" means any law or regulation including, but not limited to: (a) any domestic or foreign statute or regulation; (b) any rule or practice of any Authority with which the Agents are bound or accustomed to comply; and (c) any agreement entered into by the Trustee and any Authority or between any two or more Authorities applicable to the Trustee in the context of this Deed: "Appointee" has the meaning specified in Clause 12.21;
2 "Authority" means any competent regulatory, prosecuting, Tax or governmental authority in any jurisdiction; "Bondholder" and "holder" mean, in relation to a Bond, the person in whose name the Bond is registered in the Register; "Bonds" means the Original Bonds and/or, as the context may require, any Further Bonds except that in Schedules 2 and 3 "Bonds" means the Original Bonds: "Business Day" means, in relation to any place, a day (other than a Saturday or Sunday) on which commercial banks and foreign exchange markets are open for business in the relevant place; "Certification Date" has the meaning specified in Clause 10.5; "Clearstream, Luxembourg" means Clearstream Banking S.A.; "Conditions" means, in relation to the Original Bonds, the terms and conditions set out in Schedule 1 and, with respect to any Further Bonds, the terms and conditions set out in a schedule to the supplemental trust deed constituting such Further Bonds as any of the same may from time to time be modified in accordance with the provisions thereof and/or of this Trust Deed and with respect to any Bonds represented by a Global Bond, as modified by the provisions of such Global Bond, and references in this Trust Deed to a particular numbered Condition shall, in relation to the Original Bonds, be construed accordingly and shall, in relation to any Further Bonds, be construed as a reference to the provision (if any) in the Conditions thereof which corresponds to the particular Condition of the Original Bonds; "Code" means the U.S. Internal Revenue Code of 1986, as amended; "Contractual Currency" has the meaning specified in Clause 18.1; "Definitive Registered Bonds" means the Original Definitive Registered Bonds and/or as the context may require any other definitive registered bonds representing Further Bonds or any of them; "Euroclear means Euroclear Bank SA/NV; "Event of Default" means any of the events listed in Section 8 certified by the Trustee as materially prejudicial to the interests of the Bondholders. as applicable; "Extraordinary Resolution" has the meaning set out in Schedule 4; "FATCA Withholding" means any withholding or deduction required pursuant to an agreement described in section 1471(b) of the Code, or otherwise imposed pursuant to sections 1471 through 1474 of the Code, any regulations or agreements thereunder, any official interpretations thereof, or any law implementing an intergovernmental approach thereto: "Further Bonds" means any further Bonds issued in accordance with the provisions of Clause 5 and the Conditions and constituted by a deed supplemental to this Trust Deed: 3 "FSMA" means the Financial Services and Markets Act 2000: "Global Bond" means the Original Global Bond and/or as the context may require any other global bond representing Further Bonds or any of them except that in Schedule 3 Global Bond means the Original Global Bond; a "holding company" of a company or a corporation means any company or corporation of which the first mentioned company or corporation is a subsidiary; a "Material Subsidiary" means any Subsidiary: (i) whose (a) total assets or (b) total revenues or (c) operating result (consolidated in the case of a Subsidiary which itself has subsidiaries) represent five per cent. or more of the consolidated total assets of the Issuer and its Subsidiaries or the consolidated total revenues of the Issuer and its Subsidiaries or the operating result of the Issuer and its Subsidiaries, as the case may be, in each case as calculated by reference to the then latest audited financial statements of such Subsidiary (consolidated or, as the case may be, unconsolidated) and the then latest audited consolidated financial statements of the Issuer provided that: (a) in the case of a Subsidiary acquired or an entity which becomes a Subsidiary after the end of the financial period to which the then latest audited consolidated financial statements of the Issuer relate, the reference to the then latest audited consolidated financial statements of the Issuer for the purposes of the calculation of the above shall until the consolidated audited financial statements of the Issuer are published for the financial period in which the acquisition is made or, as the case may be, in which such entity becomes a Subsidiary, be deemed to be a reference to the then latest consolidated financial statements of the Issuer adjusted in such manner as may be deemed appropriate by the Issuer to consolidate the latest audited financial statements (consolidated or, as the case may be, unconsolidated) of such Subsidiary in such financial statements; (b) if, in the case of any Subsidiary, no audited financial statements (consolidated or, as the case may be, unconsolidated) are prepared. then the determination of whether or not such Subsidiary is a Material Subsidiary shall be determined by reference to its unaudited annual financial statements (if any) or on the basis of pro forma financial statements (consolidated or, as the case may be, unconsolidated); and (c) if the latest financial statements of any Subsidiary are not prepared on the basis of the same accounting principles, policies and practices of the latest consolidated audited financial statements of the Issuer, then the determination of whether or not such Subsidiary is a Material Subsidiary shall be based on pro forma financial statements or, as the case may be, consolidated financial statements of such Subsidiary prepared on the same accounting principles, policies and practices as adopted in the latest consolidated audited financial statements of the Issuer, or an appropriate restatement or adjustment to the relevant financial statements of each Subsidiary; or (ii) to which is transferred all or substantially all of the business, undertaking and assets of a Subsidiary which immediately prior to such transfer is a Material Subsidiary, whereupon the transferor Subsidiary shall immediately cease to be a Material Subsidiary and the transferee Subsidiary shall immediately become a Material Subsidiary under the provisions of this sub-paragraph (ii) upon publication of its next audited financial statements but so that such transferor Subsidiary or such transferee Subsidiary may be a Material Subsidiary on or at any time 4 after the date on which such audited financial statements have been published by virtue of the provisions of sub-paragraph (i) above or (as a result of another transfer to which this sub-paragraph (ii) applies) before, on or at any time after such date by virtue of the provisions of this sub-paragraph (ii). "Original Bondholders" means, in relation to an Original Bond, the person in whose name the Original Bond is registered in the Register; "Original Bonds" means the bonds in or substantially in the form set out in Schedule 2 comprising the €125,000,000 3.00 per cent. Convertible Bonds due 2025 constituted by this Trust Deed and for the time being outstanding or, as the context may require, a specific number of them and includes any replacement Bonds issued pursuant to the Conditions and (except for the purposes of Clauses 3.1 and 3.2) the Global Bond: "Original Definitive Registered Bonds" means those Original Bonds for the time being represented by definitive certificates in the form or substantially in the form set out in Schedule 2 and in accordance with Section 1.1; "Original Global Bond" means the global bond in registered form which will evidence the Original Bonds. substantially in the form set out in Schedule 3, and evidencing the registration of the person named therein in the Register; "outstanding" means, in relation to the Bonds, all the Bonds issued except (a) those which have been redeemed in accordance with the Conditions, (b) those in respect of which Conversion Rights have been exercised and all the obligations of the Issuer to deliver Shares and/or cash have been performed in relation thereto, (c) those in respect of which the date for redemption has occurred and the redemption moneys (including all interest accrued on such Bonds to the date for such redemption and any interest payable under the Conditions after such date) have been duly paid to the relevant Bondholder or on its behalf or to the Trustee or to the Principal Paying, Transfer and Conversion Agent as provided in Clause 2 and remain available for payment against surrender of Bonds (if so required), as the case may be, (d) those which have become void or those in respect of which claims have become prescribed, (e) those mutilated or defaced Bonds which have been surrendered in exchange for replacement Bonds (if so required), (f) those which have been purchased and cancelled as provided in the Conditions and (g) the Global Bond to the extent that it shall have been exchanged for interests in another Global Bond and any Global Bond to the extent that it shall have been exchanged for Definitive Registered Bonds pursuant to its provisions; provided that for the purposes of (i) ascertaining the right to attend and vote at any meeting of the Bondholders or to participate in any Written Resolution or Electronic Consent. (ii) the determination of how many Bonds are outstanding for the purposes of Sections 10, 11, 14 and 15 and Schedule 4, and (iii) the exercise of any discretion, power or authority contained in this Trust Deed or provided by law, which the Trustee is required, expressly or impliedly, to exercise in or by reference to the interests of the Bondholders, those Bonds (if any) which are beneficially held by or on behalf of the Issuer or any of its Subsidiaries and not cancelled shall be deemed not to remain outstanding; "Potential Event of Default" means any condition, event or act which. with the lapse of time, the expiry of any grace period and/or the issue. making or giving of any notice, certification, declaration, demand, determination and/or request and/or the taking of any 5 similar action and/or the fulfilment of any similar condition, would constitute an Event of Default: "Principal Paying, Transfer and Conversion Agent" means, in relation to the Original Bonds, The Bank of New York Mellon, London Branch at its specified office, in its capacity as Principal Paying, Transfer and Conversion Agent (in respect of the Original Bonds) and, in relation to any Further Bonds, the Principal Paying, Transfer and Conversion Agent appointed in respect of such Further Bonds and, in each case. any Successor Principal Paying, Transfer and Conversion Agent; "Proceedings" has the meaning specified in Clause 21.2; "Registrar" means The Bank of New York Mellon SA/NV, Luxembourg Branch at its specified office, in its capacity as Registrar and any Successor Registrar; "Securities" means any securities including, without limitation, Shares and any other shares in the capital of the Issuer and options, warrants or other rights to subscribe for or purchase or acquire Shares or any other shares in the capital of the Issuer; "Shares" means the fully-paid shares in the capital of the Issuer currently with, on the Closing Date, a nominal value of €0.01 each; "specified office" means, in relation to any Agent, either the office identified with its name at the end of the Conditions or any other office approved by the Trustee and notified to the Bondholders pursuant to Clause 10.10; "Subsidiary" means a subsidiary (dochtermaatschappj) as defined in Section 2:24a of Book 2 of the Dutch Civil Code; "Successor" means, in relation to the Agents, such other or further person as may from time to time be appointed by the Issuer as an Agent with the prior written approval of, and on terms approved in writing by, the Trustee (such approval not to be unreasonably withheld or delayed) and notice of whose appointment is given to Bondholders pursuant to Clause 10.10; "Tax" means all present or future taxes, levies, imposts, charges, assessments, deductions, withholdings and related liabilities of whatever nature imposed, levied, collated, withheld or assessed by or on behalf of any Authority having power to tax: "this Trust Deed" means this Trust Deed, the Schedules (as from time to time amended, modified and/or supplemented in accordance with this Trust Deed) and any other document executed in accordance with this Trust Deed (as from time to time so altered) and expressed to be supplemental to this Trust Deed: "Transaction Documents" means the Agency Agreement and this Trust Deed: "trust corporation" means a trust corporation (as defined in the Law of Property Act 1925) or a corporation entitled to act as a Trustee pursuant to applicable foreign legislation relating to trustees; and "Trustee Acts" means the Trustee Act 1925 and the Trustee Act 2000.
6 1.2 Construction of Certain References: References to: 1.2.1 Liabilities, costs, charges. remuneration or expenses shall include any irrecoverable value added tax, turnover tax or similar tax ("VAT") charged in respect thereof: 1.2.2 "euro" and "€" means the currency introduced at the start of the third stage of the European economic and monetary union pursuant to the Treaty establishing the European Community, as amended; 1.2.3 "Section" or "Sections" are to the relevant sections of the Conditions; 1.2.4 any action, remedy or method of judicial proceedings for the enforcement of rights of creditors shall include, in respect of any jurisdiction other than England and Wales, references to such action, remedy or method of judicial proceedings for the enforcement of rights of creditors available or appropriate in such jurisdiction as shall most nearly approximate thereto; 1.2.5 any provision of any statute shall be deemed also to refer to any statutory modification or re-enactment thereof or any statutory instrument, order or regulation made thereunder or under such modification or re-enactment; 1.2.6 "such approval not to be unreasonably withheld or delayed" or like references shall mean, when used in this Trust Deed. the Agency Agreement or the Conditions, in relation to the Trustee that, in determining whether to give consent or approval, the Trustee shall have due regard to the interests of Bondholders and any determination as to whether or not its consent or approval is unreasonably withheld or delayed shall be made on that basis; and 1.2.7 references in this Trust Deed to "reasonable" or "reasonably" and similar expressions relating to the Trustee and any exercise of power, opinion, determination or other similar matter shall be construed as meaning reasonable or reasonably (as the case may be) having due regard to, and taking into account the interests of, the Bondholders. 1.3 Conditions: Words and expressions defined in the Conditions and not defined in the main body of this Trust Deed shall when used in this Trust Deed (including the recitals) have the same meanings as are given to them in the Conditions. 1.4 Headings: Headings shall be ignored in construing this Trust Deed. 1.5 Schedules: The Schedules are part of this Trust Deed and shall have effect accordingly. 1.6 Modification etc. of Statutes: References to a statutory provision include that provision as from time to time modified or re-enacted whether before or after the date of this Trust Deed. 7 2 Amount of the Original Bonds and Covenant to pay 2.1 Amount of the Original Bonds: The aggregate principal amount of the Original Bonds is limited to €125.000,000. 2.2 Covenant to pay: The Issuer will, on any date when any Original Bonds become due to be redeemed, in accordance with this Trust Deed or the Conditions, unconditionally pay (or procure to be paid) to or to the order of the Trustee in euro in same day funds the principal amount of the Original Bonds becoming due for redemption on that date and will (subject to the Conditions) until such payment (both before and after judgment) unconditionally so pay or procure to be paid to or to the order of the Trustee interest on the principal amount of the Original Bonds outstanding as set out in the Conditions provided that (1) subject to the provisions of Clause 2.4, payment of any sum due in respect of the Original Bonds made to or to the account of the Principal Paying, Transfer and Conversion Agent as provided in the Agency Agreement shall, to that extent, satisfy such obligation except to the extent that there is failure in its subsequent payment to the relevant Original Bondholders under the Conditions and (2) a payment made after the due date or pursuant to Condition 10 will be deemed to have been made when the full amount due has been received by the Trustee or the Principal Paying. Transfer and Conversion Agent and notice to that effect has been given to the Original Bondholders (if required under Clause 10.8) except to the extent that there is a failure in the subsequent payment to the relevant holders under the Conditions. The Trustee will hold the benefit of this covenant on trust for the Original Bondholders. 2.3 Discharge: Subject to Clause 2.4, any payment to be made in respect of the Bonds by the Issuer or the Trustee may be made as provided in the Conditions and any payment so made will (subject to Clause 2.4) to such extent be a good discharge to the Issuer or the Trustee, as the case may be. 2.4 Payment after a Default: At any time after an Event of Default or a Potential Event of Default has occurred and is continuing the Trustee may: 2.4.1 by notice in writing to the Issuer and the Agents, require the Agents (or any of them), until notified by the Trustee to the contrary, so far as permitted by any applicable law: (i) to act thereafter as Agents of the Trustee under this Trust Deed and the Bonds on the terms of the Agency Agreement (with consequential amendments as necessary and except that the Trustee's liability for the indemnification, remuneration and all other out-of-pocket expenses of the Agents will be limited to the amounts for the time being held by the Trustee in respect of the Bonds on the terms of this Trust Deed) and thereafter to hold all Bonds and/or Shares received on conversion of the Bonds and all moneys, documents and records held by them in respect of Bonds and/or Shares to the order of the Trustee; or (ii) to deliver all Bonds and/or Shares received on conversion of the Bonds and all moneys, documents and records held by them in respect of the Bonds and/or Shares to the Trustee or as the Trustee directs in such notice provided that such notice shall be deemed not to apply to any documents or records which the relevant Agent is obliged not to release by any law or regulation; and 8 2.4.2 by notice in writing to the Issuer require the Issuer to make all subsequent payments in respect of the Bonds to, or to the order of. the Trustee and not to the Principal Paying, Transfer and Conversion Agent with effect from the issue of any such notice to the Issuer; and from then until such notice is withdrawn, proviso (1) to Clause 2.2 shall cease to have effect. 3 Form of the Original Bonds 3.1 The Original Global Bond: The Original Bonds will be represented by the Original Global Bond initially in the principal amount of €125,000,000 and the Issuer shall procure that appropriate entries be made in the Register of Bondholders by the Registrar to reflect the issue of such Original Bonds. The Original Global Bond will be delivered to and registered in the nominee name of a common depositary for Euroclear and Clearstream, Luxembourg. The Original Global Bond will be in or substantially in the form set out in Schedule 3. The Original Global Bond will be exchangeable for Original Definitive Registered Bonds as set out in the Original Global Bond. 3.2 The Original Definitive Registered Bonds: The Original Definitive Registered Bonds may be printed or typed and need not be security printed unless otherwise required by applicable stock exchange requirements. The Original Definitive Registered Bonds will be in or substantially in the form set out in Schedule 2. Original Definitive Registered Bonds will be endorsed with the Conditions. 3.3 Signature: The Original Global Bond and any Original Definitive Registered Bond (if issued) will be signed manually or in facsimile by two members of the Board of Management of the Issuer and will be authenticated by or on behalf of the Registrar. The Issuer may use the manual or facsimile signature of any person who is at the date of this Trust Deed a director of the Issuer even if at the time of issue of any Original Bonds he no longer holds such office. Original Bonds (including the Original Global Bond) so executed and authenticated will be valid and binding obligations of the Issuer. 4 Stamp Duties and Taxes 4.1 Stamp Duties: 4.1.1 The Issuer will pay any stamp, issue, registration, transfer, documentary and other similar documentary taxes and duties ("Transfer Taxes") payable (i) in Belgium, Luxembourg, the Netherlands or the United Kingdom on or in respect of the creation, issue and initial offering of the Bonds and the execution or delivery of this Trust Deed and (ii) in the Netherlands upon the issue and allotment of the Shares on conversion of the Bonds, other than those taxes or duties expressed to be payable by Bondholders directly to the relevant authorities pursuant to Section 5.5. 4.1.2 The Issuer will also indemnify the Trustee and the Bondholders from and against all Transfer Taxes paid by any of them in any jurisdiction in relation to which the liability to pay arises directly as a result of any action taken by or on behalf of the Trustee or, as the case may be and where entitled under Section 10 to do so, the Bondholders to enforce the obligations of the Issuer under this Trust Deed or the Bonds. 9 5 Further Issues 5.1 Liberty to Create: The Issuer may, from time to time without the consent of the Bondholders, create and issue Further Bonds, either having the same terms and conditions in all respects (or in all respects except for the amount and due date for the first payment of interest thereon and the first date on which conversion rights may be exercised) as (i) the Original Bonds or (ii) any previously issued Further Bonds so that the same shall be consolidated and form a single series with the Original Bonds or any Further Bonds, or (in any case) upon such terms as to interest, conversion, premium, redemption and otherwise as the Issuer may at the time of issue thereof determine. 5.2 Means of Constitution: Any Further Bonds created and issued pursuant to the provisions of Clause 5.1 so as to form a single series with the Original Bonds and/or the Further Bonds of any series shall be constituted by a deed supplemental to this Trust Deed and any other Further Bonds of any series created and issued pursuant to the provisions of Clause 5.1 may be so constituted. The Issuer shall, prior to the issue of any Further Bonds to be so constituted, execute and deliver to the Trustee a deed supplemental to this Trust Deed and containing a covenant by the Issuer in the form mutatis mutandis of Clause 2 of this Trust Deed in relation to such Further Bonds and such other provisions (corresponding to any of the provisions contained in this Trust Deed) as the Trustee shall require. 5.3 Noting of Supplemental Deeds: A memorandum of every such supplemental deed shall be endorsed by the Trustee on this Trust Deed and by the Issuer on the duplicate(s) of this Trust Deed. 5.4 Notice of Further Issues: Whenever it is proposed to create and issue any Further Bonds, the Issuer shall give to the Trustee not less than 14 days' notice in writing of its intention to do so, stating the principal amount of Further Bonds proposed to be created or issued. 5.5 Separate Series: Any Further Bonds not forming a single series with the Original Bonds and/or previously issued Further Bonds of any series shall form a separate series and accordingly, unless for any purpose the Trustee in its absolute discretion shall otherwise determine, the provisions of Clauses 4, 5.2, 6 and Clauses 7 to 20 (inclusive) and Schedule 4 shall apply mutatis mutandis separately and independently to the Bonds of each such series and in such Clauses and Schedule the expressions "Bonds" and "Bondholders" shall be construed accordingly. 6 Application of Moneys received by the Trustee 6.1 Declaration of Trust: All moneys received by the Trustee in respect of the Original Bonds and any Further Bonds forming a single series with the Original Bonds or amounts payable under this Trust Deed will, regardless of any appropriation of all or part of them by the Issuer, be held by the Trustee upon trust to apply them (subject to Clause 6.2): 6.1.1 first, in payment of all fees, costs, charges. expenses and liabilities properly incurred by the Trustee (including remuneration and any indemnity amounts payable to it) and/or any Appointee in carrying out its or their functions under this Trust Deed;
10 6.1.2 secondly, in payment of any and all liabilities and charges and the properly incurred fees, costs and expenses incurred by or payable to the Agents and the Calculation Agent (including remuneration and other amounts payable to them) in carrying out their functions under the Agency Agreement and the Calculation Agency Agreement, respectively; 6.1.3 thirdly, in payment of any amounts owing in respect of the Original Bonds and any Further Bonds forming a single series with the Original Bonds pari passu and rateably; and 6.1.4 fourthly, in payment of the balance (if any) to the Issuer for itself. If the Trustee holds any moneys in respect of Original Bonds and any Further Bonds forming a single series with the Original Bonds which have become void or in respect of which claims have become prescribed under the Conditions, the Trustee will hold them upon these trusts. 6.2 Accumulation: If the amount of the moneys at any time available for payment in respect of the Bonds under Clause 6.1 is less than 10 per cent. of the principal amount of the Bonds then outstanding, the Trustee may, at its discretion, invest such moneys. The Trustee may retain such investments and accumulate the resulting income until the investments and the accumulations, together with any other funds for the time being under the control of the Trustee and available for such payment, amount to at least 10 per cent. of the principal amount of the Bonds then outstanding whereupon such investments, accumulations and funds (after deduction of, or provision for. any applicable taxes) will be applied as specified in Clause 6.1. 6.3 Investment: Moneys held by the Trustee may be invested in the name, or under the control, of the Trustee in any investments or other assets anywhere, for the time being authorised by English law for the investment by trustees of trust monies. whether or not they produce income, or placed on deposit in the name or under the control of the Trustee at such bank or other financial institution and in such currency as the Trustee may. in its absolute discretion, think fit. If that bank or institution is the Trustee or a subsidiary. holding company or associated company of the Trustee, it need only account for an amount of interest equal to the standard amount of interest payable by it on such a deposit to an independent customer. The Trustee may at any time vary or transpose any such investments or assets for or into other such investments or assets or convert any moneys so deposited into any other currency, and will not be responsible to any person whatsoever for any loss occasioned thereby, whether by depreciation in value, fluctuation in exchange rates or otherwise. 7 Covenant to Comply The Issuer hereby covenants with the Trustee that it will comply with and perform and observe all the provisions of this Trust Deed which are expressed to be binding on it. The Conditions shall be binding on each of the Issuer and the Bondholders. The Trustee shall be entitled to enforce the obligations of the Issuer under the Bonds and the Conditions as if the same were set out and contained in this Trust Deed which shall be read and construed as one document with the Bonds. The provisions contained in Schedule 1 shall have effect in the same manner as if herein set forth. The Trustee shall hold the benefit of 11 this covenant upon trust for itself and the Bondholders according to its and their respective interests. 8 Conversion 8.1 Conversion Rights: The holder of each Bond will have the right to convert such Bond into Shares at any time during the Conversion Period, as provided in Section 5.1. 8.2 Discharge of Conversion obligations: The issue or transfer and delivery of Shares following an exercise of Conversion Rights with respect to a Bond and the performance by the Issuer of its obligations in respect of such exercise (including payment of any other amounts as provided in the Conditions) shall satisfy and constitute a discharge of the Issuer's obligations in respect of such Bond. 9 Covenants relating to Conversion 9.1 Covenants of the Issuer: The Issuer hereby undertakes to and covenants with the Trustee that so long as any Conversion Right remains exercisable, it will, save with the approval of an Extraordinary Resolution or with the approval of the Trustee where, in the Trustee's opinion, it is not materially prejudicial to the interests of the Bondholders to give such approval, observe and perform all its obligations under the Conditions and this Trust Deed with respect to Conversion Rights and in addition it will: 9.1.1 Notice: As soon as practicable after the announcement of the terms of any event giving rise to an adjustment of the Conversion Price, give notice to the Bondholders in accordance with Section 15.7 advising them of the date on which the relevant adjustment of the Conversion Price is likely to become effective and of the effect of exercising their Conversion Rights pending such date: and 9.1.2 Directors' Certificate: Upon the happening of an event as a result of which the Conversion Price will be adjusted, as soon as reasonably practicable deliver to the Trustee a certificate signed by two directors of the Issuer on behalf of the Issuer (which the Trustee shall be entitled to accept and rely on without further enquiry or liability to any person in respect thereof as sufficient evidence of the correctness of the matters referred to therein) setting forth brief particulars of the event, and the adjusted Conversion Price and the date on which such adjustment takes effect and in any case setting forth such other particulars and information as the Trustee may reasonably require. 10 Covenants So long as any Bond is outstanding, the Issuer covenants with the Trustee that it will: 10.1 Books of Account: keep, and procure that each Material Subsidiary keeps, proper books of account and, so far as permitted by applicable law, allow, and procure that each Material Subsidiary will allow, the Trustee and anyone appointed by the Trustee to whom the Issuer and/or the relevant Material Subsidiary has no reasonable objection, access to the books of account of the Issuer and/or the relevant Material Subsidiary, respectively, at all reasonable times during normal business hours subject to Clause 12.11; 12 10.2 Notice of Events of Default, etc.: notify the Trustee in writing promptly upon becoming aware of the occurrence of any Event of Default. Potential Event of Default. Change of Control, Delisting Event or consolidation, amalgamation or merger of the Issuer, in each case, without waiting for the Trustee to take any further action: 10.3 Information: so far as permitted by applicable law, give or procure to be given to the Trustee such information and evidence as is necessary for the performance of its functions; 10.4 Financial Statements, etc.: send to the Trustee: 10.4.1 as soon as they become available, and in any event within such period as the annual financial statements are required to be provided to shareholders under the laws of the Netherlands, one copy of every balance sheet and profit and loss account, and 10.4.2 as soon as reasonably practicable after the issue thereof, any report or other notice, statement or circular issued, or that legally or contractually should be issued, to the members (or creditors holding listed securities (or any class of them)) of the Issuer in their capacity as such; 10.5 Certificate of Directors: send to the Trustee within 14 days after its annual audited financial statements being made available to its members and in any event no later than the time of delivery to the Trustee of the annual financial statements referred to in Clause 10.4, and also within 14 days after any request by the Trustee a certificate of the Issuer in the form or substantially in the form set out in Schedule 5 signed by any two directors to the effect that, to the best of the knowledge, information and belief of such directors, having made reasonable enquiries, as at a date (the "Certification Date") being not more than seven days before the date of the certificate, no Event of Default. Potential Event of Default. breach of this Trust Deed, Change of Control, Delisting Event or consolidation, amalgamation or merger of the Issuer had occurred since the date of this Trust Deed or the Certification Date of the last such certificate (if any) or, if such an event had occurred, giving details of it; 10.6 Notices to Bondholders: send to the Trustee, at least five Business Days before the date of publication, a copy of the form of each notice to Bondholders (save for any notice given pursuant to Section 5.4(j)) and, upon publication, one copy of each notice so published, such notice to be in a form approved, such approval not to be unreasonably withheld or delayed, in writing by the Trustee, (such approval, unless so expressed, not to constitute approval for the purpose of Section 21 of FSMA of any such notice which is a communication within the meaning of Section 21 of the FSMA). For the avoidance of doubt, a copy of any notice given pursuant to Section 5.4(j) shall be provided to the Trustee in accordance with the Conditions; 10.7 Further Acts: so far as permitted by applicable law, do such further things as may be necessary in the opinion of the Trustee to give effect to this Trust Deed; 10.8 Notice of late payment: promptly upon request by the Trustee, give notice to the Bondholders of any unconditional payment to the Principal Paying, Transfer and Conversion Agent or the Trustee of any sum due in respect of the Bonds made after the due date for such payment; 13 10.9 Listing and Trading: make an application for the Original Bonds to be admitted to trading on the Open Market (Freiverkehr) segment of the Frankfurt Stock Exchange or any other internationally recognised, regularly operating. regulated or non-regulated stock exchange within 30 days following the Closing Date. Thereafter, and in respect of any Further Bonds, the Issuer will use reasonable endeavours to maintain such listing and admission to trading. If, however, the Issuer determines in good faith that it can no longer comply with its requirements for such listing, having used such endeavours, or if the maintenance of such listing or admission to trading is unduly onerous, the Issuer will instead use reasonable endeavours to obtain and maintain a listing on such other stock exchange or admission to trading on such other securities market of the Bonds as the Issuer may with the prior written approval of the Trustee (such approval not to be unreasonably withheld or delayed) decide, and shall also upon obtaining a quotation or listing of the Bonds on such other stock exchange or exchanges or securities market or markets as aforesaid, comply with the requirements of any such stock exchange or securities market; 10.10 Change in Agents: give not less than 30 days' prior notice to the Trustee and the Bondholders in accordance with Section 15.7 of any future appointment or any resignation or removal of any Agent or of any change by any Agent of its specified office or, if later, notice as soon as reasonably practicable after becoming aware thereof and not make any such appointment or removal without the prior written approval of the Trustee (such approval not to be unreasonably withheld or delayed); 10.11 Bonds held by Issuer, etc.: send to the Trustee, as soon as reasonably practicable after being so requested by the Trustee, a certificate of the Issuer signed by any two of its directors on behalf of the Issuer setting out the total number of Bonds which, at the date of such certificate, were held by or on behalf of the Issuer or its Subsidiaries and which had not been cancelled; 10.12 Early Redemption: give prior notice to the Trustee and the Bondholders of any proposed redemption pursuant to Section 4.1 or 4.2 in accordance therewith; 10.13 Authorised Signatories: upon the execution of this Trust Deed and thereafter promptly upon request by the Trustee, deliver to the Trustee (with a copy to the Principal Paying, Transfer and Conversion Agent) a list of the authorised signatories of the Issuer, together with specimen signatures of the same; 10.14 Material Subsidiaries: give to the Trustee the following: 10.14.1 at the same time as sending the certificate referred to in Clause 10.5 above and, in any event, not later than 120 days after the end of the relevant financial year a certificate signed by two directors of the Issuer as to which subsidiary undertakings of the Issuer were as at the last day of the last financial year Material Subsidiaries; 10.14.2 within 14 days of a request by the Trustee a certificate signed by two directors of the Issuer as to which subsidiaries of the Issuer were as at the date specified in such request Material Subsidiaries; and 10.14.3 as soon as reasonably practicable, after the acquisition or disposal of any company which thereby becomes or ceases to be a Material Subsidiary or after any transfer is made to any Subsidiary which thereby becomes a Material Subsidiary. a certificate to such effect signed by two directors of the Issuer, and any certificate
14 delivered to the Trustee under clauses 10.14.1 to 10.14.3 above shall, in the absence of manifest error be conclusive and binding on the Issuer, the Trustee and the Bondholders and the Trustee shall be entitled to act and rely on such certificate, without further enquiry and without liability to any person; and 10.15 Register: deliver or procure the delivery to the Trustee of an up-to-date copy of the Register in respect of the Bonds, certified as being a true, accurate and complete copy, as soon as practicable following the date hereof and at such other times as the Trustee may reasonably require. 11 Remuneration and Indemnification of the Trustee 11.1 Normal Remuneration: So long as any Bond is outstanding, the Issuer will pay to the Trustee by way of remuneration for its services as Trustee such sum as may from time to time be agreed between them. Such remuneration will accrue from day to day from the date of this Trust Deed and shall be payable in advance, annually as may be agreed between the Issuer and the Trustee. However, if any payment to a Bondholder of the moneys due in respect of any Bond is improperly withheld or refused upon due surrender (if so required) of such Bond, such remuneration will again accrue as from the date of such surrender (if so required) until payment to such Bondholder is duly made. 11.2 Extra Remuneration: At any time after the occurrence of an Event of Default, or a Potential Event of Default. the Issuer hereby agrees that the Trustee shall be entitled to be paid additional remuneration calculated at its normal hourly rates in force from time to time. In any other case, if the Trustee (a) finds it expedient or necessary in the interests of Bondholders or (b) is requested by the Issuer to undertake duties which the Trustee agrees to be of an exceptional nature or otherwise outside the scope of the normal duties of the Trustee under this Trust Deed, then the Issuer will pay such additional remuneration to the Trustee as may be agreed between them (and which may be calculated by reference to the Trustee's normal hourly rates in force from time to time). For the avoidance of doubt any duties in connection with the granting of consents or waivers, concurring in modifications or enforcement, prior to or during the period post enforcement shall be deemed to be of an exceptional nature. 11.3 Remuneration in absence of agreement: Failing agreement as to any of the matters in Clause 11.2 (or as to such sums referred to in Clause 11.1), a financial institution or any other person (acting as an expert) selected by the Trustee and approved by the Issuer or, failing such approval, nominated by the President for the time being of The Law Society of England and Wales, shall determine the matters in Clause 11.2 (or such sums referred to in Clause 11.1) (as applicable), the expenses involved in such selection and approval and the fee of the relevant financial institution or other person (acting as an expert) being borne by the Issuer. The determination of the relevant financial institution or other person (acting as an expert) will, be conclusive and binding on the Issuer, the Trustee and the Bondholders. 11.4 Expenses: The Issuer will also on demand by the Trustee pay or discharge all Liabilities (defined below) properly incurred by the Trustee and, if applicable, any Appointee in relation to the preparation and execution of this Trust Deed and the carrying out and/or performance of its functions under this Trust Deed including, but not limited to. properly incurred and documented legal and travelling expenses paid or payable by the Trustee in connection with any action reasonably taken or contemplated by or on behalf of the 15 Trustee or any Appointee for enforcing any obligation under this Trust Deed or the Bonds or any other Transaction Document or resolving any doubt concerning, or for any other purpose in relation to, any of the Transaction Documents. "Liabilities" means any loss, liability, damage, charge, cost, fee, claim, action. demand, expense, judgment, proceeding or other liability whatsoever (including, without limitation. in respect of taxes, duties, levies, imposts and other charges, but excluding, for the avoidance of doubt, any taxes in respect of income or profits) and any legal fees and expenses on a full indemnity basis, and except such as may result from the Trustee's or, as the case may be, Appointee's fraud, gross negligence or wilful misconduct or that of its officers, employees or directors. 11.5 Payment of Expenses: All such Liabilities properly incurred and payments made by the Trustee will be payable or reimbursable by the Issuer on demand by the Trustee and: 11.5.1 in the case of payments made by the Trustee prior to such demand, will carry interest from the date on which the demand is made at the rate equal to the Trustee's cost of funds on the date on which such payments were made by the Trustee; and 11.5.2 in all other cases, will carry interest at such rate from the date specified as the payment date in such demand. 11.6 Indemnity: Without prejudice to the right of indemnity by law given to trustees, the Issuer will on demand indemnify the Trustee and every Appointee and keep it or him indemnified against all Liabilities properly incurred by the Trustee and every Appointee in relation to the preparation and execution or purported execution of any of its or his trusts, powers, authorities and discretions and the performance of its or his duties under, and in any other manner in relation to, this Trust Deed or the Bonds or any other Transaction Documents (including but not limited to all Liabilities incurred in disputing or defending any of the foregoing). The Contracts (Rights of Third Parties) Act 1999 applies to this Clause 11.6. 11.7 Provisions Continuing: The provisions of Clauses 11.4, 11.5 and 11.6 will continue in full force and effect in relation to the Trustee even if it may have ceased to be Trustee and not withstanding any termination or discharge of this Trust Deed. 11.8 Monies Payable: All monies paid to the Trustee by the Issuer under Clauses 4.1.2, 11 and 18.3 of this Trust Deed shall be made without set-off, counterclaim, deduction or withholding for or on account of tax except as required by law. If the Issuer is required by law to make a deduction or withholding for or on account of tax on a payment to be made by it under Clauses 4.1.2, 11 and 18.3, the amount of the relevant payment shall be increased to an amount which (after making the deduction or withholding) leaves an amount equal to the sum which would have been received if no such deduction or withholding had been required to be made. 12 Provisions Supplemental to The Trustee Act 1925 and the Trustee Act 2000 12.1 Advice: The Trustee may act and/or rely on the opinion, report or advice of, or information obtained from, any lawyer. accountant, banker, financial adviser, financial institute, an Independent Adviser or other relevant expert and will not be responsible to anyone for any loss or liability occasioned by so acting and/or relying whether such advice is obtained by or addressed to the Issuer, the Trustee or any other person or contains a monetary or other limit on liability. Any such opinion, advice, report or information may be sent or 16 obtained by letter, email or facsimile transmission and the Trustee will not be liable to anyone for acting in good faith on any opinion, advice, report or information purporting to be conveyed by such means even if it contains some error or is not authentic. 12.2 Trustee to Assume Due Performance: The Trustee need not notify anyone of the execution of this Trust Deed or any other Transaction Documents and shall be under no obligation to monitor the performance of the Issuer or any other party of their obligations under this Trust Deed or any other Transaction Documents, or do anything to ascertain whether any Event of Default, Potential Event of Default, Change of Control, Delisting Event or consolidation, amalgamation or merger of the Issuer has occurred and will not be responsible to Bondholders or any other person for any loss arising from any failure by it to do so. Until it has actual knowledge or express written notice to the contrary, the Trustee may assume that no such event has occurred and that the Issuer and each other party are performing all their obligations under the Transaction Documents and the Bonds. 12.3 Resolutions of Bondholders: The Trustee will not be responsible and shall have no liability whatsoever to any person for having acted in good faith upon a resolution purporting to have been passed at a meeting of Bondholders in respect of which minutes have been made and signed or upon any direction or request, including a written resolution or electronic consent made in accordance with Paragraph 20 of Schedule 4 even though it may later be found that there was a defect in the constitution of such meeting or the passing of such resolution or that such resolution was not valid or binding upon the Bondholders. 12.4 Reports: The Trustee is entitled to accept and rely without liability to any person for so relying on any report, confirmation or certificate where the Issuer procures delivery of the same pursuant to its obligation to do so under the Conditions or a provision hereof and such report, confirmation or certificate shall be conclusive and binding on the Issuer, the Trustee and the Bondholders in the absence of manifest error. 12.5 Certificate Signed by Directors: The Trustee may call for and may accept as sufficient evidence of any fact or matter or of the expediency of any act a certificate of the Issuer signed by any two directors of the Issuer on behalf of the Issuer as to any fact or matter upon which the Trustee may, in the exercise of any of its functions, require to be satisfied or to have information to the effect that, in the opinion of the person or persons so certifying, any particular act is expedient and the Trustee need not call for further evidence and will not be responsible or liable to any person for any loss that may be occasioned by acting on any such certificate. 12.6 Deposit of Documents: The Trustee may appoint as custodian, on any terms, any bank or entity whose business includes the safe custody of documents or any lawyer or firm of lawyers believed by it to be of good repute and may deposit this Trust Deed and any other documents with such custodian and pay all sums due in respect thereof. The Trustee is not obliged to appoint a custodian of securities payable to bearer. 12.7 Discretion of Trustee: The Trustee will have absolute and uncontrolled discretion as to the exercise of its functions and will not be responsible for any loss, liability, cost, claim, action, demand. expenses or inconvenience which may result from their exercise or non- exercise. 17 12.8 Agents: Whenever it considers it expedient in the interests of the Bondholders, the Trustee may, in the conduct of its trust business, instead of acting personally, employ and pay an agent selected by it, whether or not a lawyer or other professional person, to transact or conduct, or concur in transacting or conducting, any business and to do or concur in doing all acts required to be done by the Trustee (including the receipt and payment of money). 12.9 Delegation: Whenever it considers it expedient in the interests of the Bondholders, the Trustee may delegate to any person and on any terms (including power to sub-delegate) all or any of its functions. Such delegation may be made on such terms (including power to sub- delegate) and subject to such conditions and regulations as the Trustee may in the interests of the Bondholders think fit. 12.10 Forged Bonds: The Trustee will not be liable to the Issuer or any Bondholder by reason of having accepted as valid or not having rejected any entry in the Register or any Bond purporting to be such and later found to be forged or not authentic nor shall it be liable for any action taken or omitted to be taken in reliance on any document, certificate or communication believed by it to be genuine and to have been presented or signed by the proper parties. 12.11 Confidentiality: Unless ordered to do so by a court of competent jurisdiction, the Trustee shall not be required to disclose to any Bondholder or any third party any confidential financial or other information made available to the Trustee by the Issuer and no Bondholder shall be entitled to take any action to obtain from the Trustee any such information. 12.12 Determinations Conclusive: As between itself and the Bondholders, the Trustee may determine all questions and doubts arising in relation to any of the provisions of this Trust Deed. Every such determination, whether made upon such a question actually raised or implied in the acts or proceedings of the Trustee, will be conclusive in the absence of manifest error and shall bind the Trustee and the Bondholders. 12.13 Currency Conversion: Where it is necessary or desirable in relation to this Trust Deed or the Conditions to convert any sum from one currency to another, it will (unless otherwise provided hereby or required by law) be converted at such rate or rates, in accordance with such method and as at such date as may reasonably be specified by the Trustee but having regard to current rates of exchange, if available. Any rate, method and date so specified will be binding on the Issuer and the Bondholders. 12.14 Events of Default: The Trustee may determine whether or not an Event of Default is in its opinion capable of remedy and/or whether or not any event is in its opinion materially prejudicial to the interests of the Bondholders. Any such determination will be conclusive and binding upon the Issuer and the Bondholders. 12.15 Payment for and Delivery of Bonds: The Trustee will not be responsible for the receipt or application by the Issuer of the proceeds of the issue of the Bonds or the exchange of the Original Global Bond for Original Definitive Registered Bonds or the delivery of the Original Global Bond or any Original Definitive Registered Bond to the person(s) entitled to it or them.
18 12.16 Bonds held by the Issuer, etc.: In the absence of actual knowledge or express notice to the contrary, the Trustee may assume without enquiry (other than requesting a certificate of the Issuer under Clause 10.11) that no Bonds are for the time being held by or on behalf of the Issuer or its Subsidiaries. 12.17 Interests of Bondholders: In connection with the exercise of its powers, trusts, authorities or discretions (including, but not limited to, those in relation to any proposed modification, waiver or authorisation of any breach or proposed breach of any of the Conditions or any of the provisions of this Trust Deed or any determination to be made by it under this Trust Deed), the Trustee shall have regard to the general interests of the Bondholders as a class and shall not have regard to the consequences of such exercise for individual Bondholders nor to circumstances particular to individual Bondholders (whatever their number) and, in particular, but without prejudice to the generality of the foregoing, shall not have regard to the consequences of any such exercise for individual Bondholders resulting from their being for any purpose domiciled or resident in, or otherwise connected with, or subject to the jurisdiction of, any particular territory or otherwise to the tax consequences thereof and the Trustee shall not be entitled to require, nor shall any Bondholder be entitled to claim from the Issuer or the Trustee, any indemnification or payment of any tax arising in consequence of any such exercise upon individual Bondholders except to the extent provided for in Section 6 and/or in any undertakings given in addition thereto or in substitution therefor pursuant to this Trust Deed. For the avoidance of doubt, the Trustee shall not at any time have regard to the interests of the holders of Shares. 12.18 No Responsibility for Share Value: The Trustee shall not at any time be under any duty or responsibility to or have any liability to any Bondholder or to any other person to (i) monitor or take any steps to ascertain whether a Conversion Right is exercisable or whether any facts exist or may exist. which may require an adjustment to the Conversion Price or (ii) review either the nature or extent of any such adjustment when made or the method employed in making any such adjustment pursuant to the provisions of this Trust Deed or (iii) make or verify any calculations or determination made as to the number of Shares or the methodology used therefor and will not be responsible or liable to any person for any loss occasioned thereby. The Trustee shall not at any time be under any duty or responsibility or liability in respect of the validity or value (or the kind or amount) of any Shares or other shares or any other Securities or property, which may at any time be made available or delivered in the exercise of any Conversion Right and it makes no representation with respect thereto. The Trustee shall not be responsible or liable to any person for any failure of the Issuer to deliver any Shares or other shares or share certificates or other securities or any other amounts in respect of any Bond or of the Issuer to comply with any of the covenants contained in this Trust Deed. 12.19 Nominees: In relation to any asset held by it under this Trust Deed, the Trustee may appoint any person to act as its nominee on any terms. 12.20 Breach of Undertakings: The Trustee assumes no responsibility for ascertaining whether or not (i) a breach of any of the undertakings in Section 7 shall have occurred or (ii) any such breach shall have been rectified or (iii) any adjustment falls to be made to the Conversion Price as a result thereof and shall have no liability to any person for not so doing. Unless and until the Trustee has actual knowledge of any of the above events it shall be entitled to assume that no such event has occurred. The Trustee shall not be 19 liable for any loss arising from any determination or calculation made pursuant to the Conditions or from any failure or delay in making any such determination or calculation. 12.21 Responsibility for agents, etc.: If the Trustee exercises reasonable care in selecting any custodian, agent, delegate or nominee appointed under this Trust Deed (an "Appointee"), it will not have any obligation to supervise the Appointee or to be responsible for any loss, liability, cost, claim, action, demand or expense incurred by anyone whatsoever by reason of the Appointee's misconduct or default or the misconduct or default of any substitute appointed by the Appointee. 12.22 Clearing Systems: The Trustee may call for any certificate or other document to be issued by Euroclear or Clearstream. Luxembourg or any other relevant clearing system in relation to any matter. Any such certificate or other document shall, in the absence of manifest error, be conclusive and binding for all purposes. Any such certificate or other document may comprise any form of statement or print out of electronic records provided by the relevant clearing system (including Euroclear's EUCLID or Clearstream, Luxembourg's CreationOnline system) in accordance with its usual procedures and in which the holder of a particular principal amount of Bonds is clearly identified together with the amount of such holding. The Trustee shall not be liable to any person by reason of having accepted as valid or not having rejected any certificate or other document to such effect purporting to be issued by Euroclear or Clearstream, Luxembourg and subsequently found to be forged or not authentic. 12.23 Legal Opinions: The Trustee shall not be responsible to any person for failing to request, require or receive any legal opinion relating to the Bonds or for checking or commenting upon the content of any such legal opinion and shall not be responsible for any loss, damage, cost, charge, claim, demand, expense, judgment, action, proceeding or other liability whatsoever incurred thereby. The Trustee shall be entitled to call for and rely upon (without liability to any person), and the Issuer shall be obliged to use reasonable endeavours to procure the delivery of, legal opinions addressed to the Trustee dated the date of such delivery and in a form and content acceptable to the Trustee. 12.24 Illegality, etc: Notwithstanding anything else contained in this Trust Deed or any other Transaction Document, the Trustee shall refrain from doing anything which may, in the opinion of the Trustee, (i) be illegal or contrary to applicable law, directive or regulation of any agency of any state which would or might otherwise render it liable to any person and may do anything which in its opinion, is necessary to comply with any such law, directive or regulation; or (ii) cause it to expend or risk its own funds or otherwise incur any liability in the performance of any of its duties or in the exercise of any right, authority, power or discretion under the Transaction Documents, or suffer any loss, damage, cost, charge, claim, demand, expense, judgment, action, proceeding or other liability whatsoever, if it shall have reasonable grounds for believing that repayment and/or prepayment of such funds or adequate indemnity and/or security against such risk or loss, damage, cost, charge, claim, demand, expense, judgment, action, proceeding or other liability whatsoever is not assured to it. 12.25 Investigation: The Trustee shall not be responsible for, or for investigating any matter which is the subject of, any recital, statement, representation, warranty or covenant of any person contained in this Trust Deed, or any other agreement or document relating to the transactions contemplated herein or under such other agreement or document. 20 12.26 Indemnity: Notwithstanding anything else contained in this Trust Deed, the Trustee shall not be bound to take any action or step or proceeding or exercise any right, power, authority or discretion vested in it under this Trust Deed or any other agreement relating to the transactions herein contemplated including, but not limited to forming an opinion or employing a financial adviser until it has been indemnified and/or secured and/or prefunded to its satisfaction and may demand prior to taking any such steps, action or proceedings that there be paid to it in advance such sums as it reasonably considers (without prejudice to any further demand) shall be sufficient so as to indemnify and/or secure and/or prefund it and on such demand being made on the Issuer, the Issuer shall be obliged to make payment of all such sums in full. The Trustee shall not be liable to any person whatsoever for any loss occasioned by it not acting unless and until it shall have been so indemnified and/or secured and/or prefunded to its satisfaction. 12.27 Refrain from action: In relation to any discretion to be exercised or proceedings, actions or steps (including lodging an appeal in any proceedings) to be taken by the Trustee under this Trust Deed. the Bonds or the Agency Agreement, the Trustee may, at its discretion and without further notice, or shall, if it has been so directed by an Extraordinary Resolution of Bondholders or so requested in writing by the holders of at least one-quarter in principal amount of Bonds then outstanding (where relevant), exercise such discretion or take such proceedings, actions or steps, provided that, in either case, the Trustee shall not be obliged to exercise such discretion or take such actions, steps or proceedings unless it shall have been indemnified and/or secured and/or prefunded to its satisfaction and provided that the Trustee shall not be held liable for the consequences of exercising or not exercising its discretion or taking or not taking any such action, step or proceeding and may do so without having regard to the effect of such action, step or proceeding on individual Bondholders. 12.28 Experts and Auditors: Any confirmation, certificate or report of accountants, financial advisers. investment bank, Independent Advisers or other experts called for by or provided to the Trustee (whether or not addressed to the Trustee) in accordance with or for the purposes of this Trust Deed may be relied upon by the Trustee (without liability to any person) as sufficient evidence of the facts stated therein notwithstanding that such certificate or report and/or any engagement letter or other document entered into by the Trustee or any other person in connection therewith contains a monetary or other limit on the liability of such expert or such other person in respect thereof and notwithstanding that the scope and/or basis of such certificate or report may be limited by any engagement or similar letter or by the terms of the certificate or report itself. 12.29 Independent Adviser: If the Issuer fails to select an Independent Adviser when required to do so pursuant to the Conditions and such failure continues for a reasonable period (as determined by the Trustee in its sole discretion), the Trustee may following notification thereof to the Issuer do so but shall not be obliged to do so unless it is indemnified and/or secured and/or prefunded to its satisfaction against all liabilities, costs, fees and expenses incurred in doing so, including those of the Independent Adviser itself. The Trustee has no responsibility for the accuracy or otherwise of any determination made by an Independent Adviser pursuant to the Conditions. 12.30 Execution and Enforceability: The Trustee shall not be responsible for the execution, delivery, legality, effectiveness, adequacy, genuineness, validity, performance, enforceability or admissibility in evidence of this Trust Deed or any other document relating or expressed to be supplemental thereto and shall not be liable for any failure to obtain 21 any licence. consent or other authority for the execution, delivery, legality, effectiveness, adequacy, genuineness, validity, performance, enforceability or admissibility in evidence of this Trust Deed or any other document relating or expressed to be supplemental thereto. 12.31 Error of Judgement: The Trustee shall not be in any way responsible for any liability incurred by reason of any error of judgment made in good faith by any of its employees or agents. 12.32 FSMA: Notwithstanding anything in this Trust Deed or any other Transaction Document to the contrary, the Trustee shall not do, or be authorised or required to do, anything which might constitute a regulated activity for the purposes of FSMA unless it is authorised under FSMA to do so. The Trustee shall have discretion at any time: (i) to delegate any of the functions which fall to be performed by an authorised person under FSMA to any other agent or person which also has the necessary authorisations and licenses: and (ii) to apply for authorisation under FSMA and perform any or all such functions itself if, in its absolute discretion. it considers it necessary, desirable or appropriate to do so. Nothing in this Trust Deed shall require the Trustee to assume an obligation of the Issuer arising under any provisions of the listing. prospectus, disclosure or transparency rules (or equivalent rules of any other competent authority besides the Financial Conduct Authority). 12.33 Personal Data: Notwithstanding the other provisions of the Transaction Documents, the Trustee may collect, use and disclose personal data about the parties (if any are an individual) or individuals associated with the Issuer and/or other parties, so that the Trustee can carry out its obligations to the Issuer and/or the other parties and for other related purposes, including auditing, monitoring and analysis of its business, fraud and crime prevention, money laundering, legal and regulatory compliance by the Trustee or members of the Trustee's corporate group of other services. The Trustee may also transfer the personal data to any country (including countries outside the European Economic Area where there may be less stringent data protection laws) to process information on the Trustee's behalf. 12.34 No Duty to Monitor: The Trustee shall not be under any duty to monitor whether any event or circumstance has happened or exists or may happen or exist and which requires or may require an adjustment to be made to the Conversion Price and will not be responsible or liable to any person for any loss arising from any failure or delay by it to do so, nor shall the Trustee be responsible or liable to any person for any determination of whether or not an adjustment to the Conversion Price is required or should be made nor as to the determination or calculation of any such adjustment. The Trustee shall not be required to take any steps to monitor or ascertain whether a Change of Control, a Delisting Event, consolidation, amalgamation or merger of the Issuer or any event or circumstance which could lead to a Change of Control, a Delisting Event or a consolidation, amalgamation or merger has occurred or may occur and will not be responsible or liable to Bondholders or any other person for any loss arising from any failure or delay by it to do so. 12.35 Withholding Tax by the Trustee: Notwithstanding anything contained herein, to the extent required by any applicable law, if the Trustee is required to make any deduction or withholding for or on account of tax from any distribution or payment made by it under this Trust Deed or if the Trustee is otherwise charged to, or may become liable to, tax as a consequence of performing its duties under this Trust Deed and whether by reason of any
22 assessment, prospective assessment or other imposition of liability to taxation of whatsoever nature and whensoever made upon the Trustee, and whether in connection with or arising from any sums received or distributed by it or to which it may be entitled under this Trust Deed or any Bonds from time to time representing the same, including any income or gains arising therefrom, or any action of the Trustee in or about the administration of the trusts hereunder or otherwise, in any case other than any tax payable by the Trustee on its income or profits, then the Trustee shall be entitled to make such deduction or withholding or (as the case may be) to retain out of sums received by it in respect of this Trust Deed an amount sufficient to discharge any such liability to tax which relates to sums so received or distributed or to discharge any such other liability of the Trustee to tax from the funds held by the Trustee on the trusts hereunder and, in respect of any such deduction or withholding, the Trustee shall account to the relevant authorities for the amount so withheld or deducted and shall provide the Issuer with appropriate evidence or documentation showing that such amount has been duly paid to the relevant authorities. 12.36 Notice of Possible Withholding Under FATCA: The Issuer shall notify the Trustee if it determines that any payment to be made by the Trustee under any Bonds is a payment which could be subject to FATCA Withholding if such payment were made to a recipient that is generally unable to receive payments free from FATCA Withholding, and the extent to which the relevant payment is so treated, provided, however, that the Issuer's obligation under this Clause 12.36 shall apply only to the extent that such payments are so treated by virtue of characteristics of the Issuer, any Bonds or both. 12.37 Issuer Right to Redirect: If the Issuer determines in its sole discretion that any deduction or withholding for or on account of any Tax will be required by Applicable Law in connection with any payment due to any of the Agents on any Bonds. then the Issuer will be entitled to redirect or reorganise any such payment in any way that it sees fit in order that the payment may be made without such deduction or withholding provided that, any such redirected or reorganised payment is made through a recognised institution of international standing and otherwise made in accordance with the Agency Agreement and this Trust Deed. The Issuer will promptly notify the Agents and the Trustee of any such redirection or reorganisation. For the avoidance of doubt, FATCA Withholding is a deduction or withholding which is deemed to be required by Applicable Law for the purposes of this Clause 12.37. 12.38 Determinations by Trustee: When determining whether an indemnity or any security or pre-funding is satisfactory to it, the Trustee shall be entitled (i) to evaluate its risk in any given circumstance by considering the worst-case scenario and (ii) to require that any indemnity or security or prefunding given to it by the Bondholders or any of them or any other person be given on a joint and several basis and be supported by evidence satisfactory to it as to the financial standing and creditworthiness of each counterparty and/ or as to the value of the security and an opinion as to the capacity, power and authority of each counterparty and/or the validity and effectiveness of the indemnity, security and/or prefunding. 13 Trustee Liability 13.1 Trustee Liability: Section 1 of the Trustee Act 2000 shall not apply to the duties of the Trustee in relation to the trusts constituted by this Trust Deed, subject to Sections 750 and 751 of the Companies Act 2006 (if applicable) provided that if the Trustee fails to show 23 the degree of care and diligence required of it as trustee, nothing in this Trust Deed shall relieve or indemnify it from or against any liability which would otherwise attach to it in respect of any fraud. gross negligence or wilful misconduct of which it may be guilty. Where there are any inconsistencies between the Trustee Acts and the provisions of this Trust Deed, the provisions of this Trust Deed shall prevail to the extent allowed by law. In the case of an inconsistency with the Trustee Act 2000. the provisions of this Trust Deed shall take effect as a restriction or exclusion for the purposes of that act. 13.2 Consequential loss: Any liability of the Trustee arising under the Transaction Documents shall be limited to the amount of actual loss suffered (such loss shall be determined as at the date of default of the Trustee or, if later, the date on which the loss arises as a result of such default) but without reference to any special conditions or circumstances known to the Trustee at the time of entering into the Transaction Documents, or at the time of accepting any relevant instructions, which increase the amount of the loss. In no event shall the Trustee be liable for any loss of profits, goodwill. reputation, business opportunity or anticipated saving, or for special, punitive or consequential damages, whether or not the Trustee has been advised of the possibility of such loss or damages and regardless of whether the claim for loss or damage is made in negligence, for breach of contract or otherwise. 14 Enforcement, Waiver and Proof of Default 14.1 Waiver: The Trustee may, without the consent of the Bondholders and without prejudice to its rights in respect of any subsequent breach, from time to time and at any time, if in its opinion the interests of the Bondholders will not be materially prejudiced thereby, waive or authorise, on such terms and conditions as seem expedient to it, any breach or proposed breach by the Issuer of the Conditions or any of the provisions of this Trust Deed, any trust deed supplemental to this Trust Deed, the Agency Agreement, any agreement supplemental to the Agency Agreement, or the Bonds or determine without any such consent as aforesaid that any Event of Default or Potential Event of Default will not be treated as such, provided that in the opinion of the Trustee, the interests of bondholders will not be materially prejudiced thereby and the Trustee will not do so in contravention of any express direction given by an Extraordinary Resolution or a request made pursuant to Section 8 but no such direction or request will affect any previous waiver, authorisation or determination. Any such waiver, authorisation or determination will be binding on the Bondholders and, if the Trustee so requires, will be notified promptly by the Issuer to the Bondholders. 14.2 Proof of Default: If it is proved that as regards any specified Bond the Issuer has made default in paying any sum due to the relevant Bondholder, such proof will (unless the contrary be proved) be sufficient evidence that the same default has been made as regards all other Bonds which are then payable. 14.3 Enforcement: The Trustee may, at any time at its discretion and without further notice, take such proceedings, actions or steps (including lodging an appeal in any proceedings) against the Issuer as it may think fit to recover any amounts due in respect of the Bonds and to enforce the provisions of this Trust Deed or the Conditions, but it will not be bound to take any such proceedings, actions or steps unless (i) it shall have been so directed by an Extraordinary Resolution or so requested in writing by the holders of at least one quarter in principal amount of the Bonds then outstanding, and (ii) it shall have been indemnified and/or secured and/or pre-funded to its satisfaction. 24 The Trustee shall not be held liable for the consequence of taking or refraining from taking any such action, step or proceedings and may take such action, step or proceedings without having regard to the effect of such action on individual Bondholders. Only the Trustee may enforce the provisions of the Bonds or this Trust Deed and no Bondholder shall be entitled to proceed directly against the Issuer unless the Trustee, having become bound so to proceed, fails to do so within a reasonable period and such failure is continuing. 15 Trustee not precluded from entering into Contracts The Trustee, associated companies and any other person, whether or not acting for itself may acquire, hold or dispose of, any Bond or any Shares or other Securities (or any interest therein) of the Issuer or any other person with the same rights as it would have had if the Trustee were not Trustee and may enter into or be interested in any contracts or transactions with the Issuer or any such person and may act as depositary, trustee or agent or in any other capacity for, or on any committee or body of holders of, any Securities issued or guaranteed by, or related to the Issuer or any such person and will not be liable to account for any profit. 16 Modification The Trustee may agree without the consent of the Bondholders to (i) any modification to the Conditions or the provisions of this Trust Deed, any trust deed supplemental to this Trust Deed. the Agency Agreement and any agreement supplemental to the Agency Agreement or the Bonds which in its opinion is of a formal, minor or technical nature or which is made to correct a manifest error or to comply with mandatory provisions of law and (ii) any other modification to the Conditions or the provisions of this Trust Deed, any trust deed supplemental to this Trust Deed, the Agency Agreement and any agreement supplemental to the Agency Agreement or the Bonds (but such power does not extend to any such modification as is mentioned in the proviso to paragraph 17.8 of Schedule 4) which is in its opinion not materially prejudicial to the interests of the Bondholders. Any such modification shall be binding on the Bondholders and such modification shall be notified by the Issuer to the Bondholders promptly in accordance with Section 15.7. 17 Appointment, Retirement and Removal of the Trustee 17.1 Appointment: Subject as provided in Clause 17.2 below, and subject to obtaining any consents or approvals as may be required by the laws or regulations of the Netherlands, the Issuer has the power of appointing a new trustee or trustees but no person will be so appointed unless previously approved by an Extraordinary Resolution. A trust corporation will at all times be a Trustee and may be the sole Trustee. Any appointment of a new Trustee will be notified by the Issuer to the Bondholders and the Principal Paying, Transfer and Conversion Agent as soon as reasonably practicable. 17.2 Retirement and Removal: Any Trustee may retire at any time on giving not less than three months' notice in writing to the Issuer without giving any reason and without being responsible for any costs (which costs shall be borne by the Issuer) occasioned by such retirement and the Bondholders may by Extraordinary Resolution remove any Trustee provided that the retirement or removal of any sole trustee or sole trust corporation will not become effective until a trust corporation is appointed as successor Trustee. If a sole trustee or sole trust corporation gives notice of retirement or an Extraordinary Resolution 25 is passed for its removal under this Clause, the Issuer will be entitled, and will use reasonable endeavours to procure that another trust corporation be appointed as Trustee but if it fails to do so before the expiry of such three month notice period, the Trustee shall have the power to appoint a new Trustee with all the costs of such appointment being borne by the Issuer. 17.3 Co-Trustees: The Trustee may, notwithstanding Clause 17.1, by prior notice in writing to the Issuer appoint anyone to act as an additional Trustee jointly with the Trustee: 17.3.1 if the Trustee considers such appointment to be in the interests of the Bondholders; or 17.3.2 for the purpose of conforming with any legal requirement, restriction or condition in any jurisdiction in which any particular act is to be performed; or 17.3.3 for the purpose of obtaining a judgment in any jurisdiction or the enforcement in any jurisdiction against the Issuer of either a judgment already obtained or any of the provisions of this Trust Deed. Subject to the provisions of this Trust Deed, the Trustee may confer on any person so appointed such functions as it thinks fit. The Trustee may, by notice in writing to the Issuer and such person, remove any person so appointed. At the request of the Trustee. the Issuer will do such things as may be reasonably required to perfect such appointment or removal and each of them irrevocably appoints the Trustee to be its attorney in its name and on its behalf to do so. 17.4 Competence of a Majority of Trustees: If there are more than two Trustees the majority of such Trustees will (provided such majority includes a trust corporation) be competent to carry out all or any of the Trustee's functions. 17.5 Merger: Any corporation into which the Trustee may be merged or converted or with which it may be consolidated, or any corporation resulting from any merger, conversion or consolidation to which the Trustee shall be a party, or any corporation succeeding to all or substantially all the corporate trust business of the Trustee, shall be the successor of the Trustee hereunder, provided such corporation shall be otherwise qualified and eligible under this Clause 17. without the execution or filing of any paper or any further act on the part of any of the parties hereto. 18 Currency Indemnity 18.1 Currency of Account and Payment: Euro (the "Contractual Currency") is the sole currency of account and payment for all sums payable by the Issuer under or in connection with this Trust Deed and the Bonds. including damages. 18.2 Extent of Discharge: An amount received or recovered in a currency other than the Contractual Currency (whether as a result of, or of the enforcement of, a judgment or order of a court of any jurisdiction, in the insolvency, bankruptcy, winding-up or dissolution of the Issuer or otherwise) by the Trustee or any Bondholder in respect of any sum expressed to be due to it from the Issuer will only discharge the Issuer to the extent of the Contractual Currency amount which the recipient is able to purchase with the amount so received or recovered in that other currency on the date of that receipt or recovery (or, if it is not
26 practicable to make that purchase on that date, on the first date on which it is practicable to do so). 18.3 Indemnity: If that Contractual Currency amount is less than the Contractual Currency amount expressed to be due to the recipient under this Trust Deed or the Bonds, the Issuer will indemnify the recipient against any loss sustained by it as a result. In any event, the Issuer will indemnify the recipient against the cost of making any such purchase. 18.4 Indemnity separate: The indemnities in this Clause 18 and in Clause 11.6 constitute separate and independent obligations from the other obligations in this Trust Deed, will give rise to a separate and independent cause of action, will apply irrespective of any indulgence granted by the Trustee and/or any Bondholder and will continue in full force and effect despite any judgment, order. claim or proof for a liquidated amount in respect of any sum due under this Trust Deed, the Bonds or any other judgment or order. 19 Communications 19.1 Modes of Communication: Any communication shall be by letter, email or facsimile transmission: in the case of the Issuer, to the Issuer at: Address: Pharming Group N.V. Darwinweg 24 2333 CR Leiden The Netherlands Fax: +31 (0)71 5247 445 Email: R.Wright@pharming.com Attention: Robin Wright, Chief Financial Officer and in the case of the Trustee, to it at: Address: BNY Mellon Corporate Trustee Services Limited One Canada Square London E14 5AL United Kingdom Fax No.: +44 (0) 207 964 2536 Email: corpsov2@bnymellon.com Attention: Trustee Administration Manager or to such other address, email. facsimile number or attention details as shall have been notified (in accordance with this Clause) to the other parties hereto. Communications will take effect, in the case of a letter, when delivered, in the case of email, when the relevant receipt of such email communication being read is given. or where no read receipt is requested by the sender, at the time of sending provided that no delivery failure notification is received by the sender within 24 hours of sending such email communication, and in the case of a fax, when the relevant delivery receipt is received by the sender; provided that any communication which is received (or deemed to take effect in accordance with the foregoing) after 5:00pm on a business day or at any time on a non- business day in the place of receipt shall be deemed to take effect at the opening of 27 business on the next following business day in such place. Any communication delivered to any party under this Trust Deed which is to be sent by fax or email will be written legal evidence. 19.2 Communications: In no event shall the Trustee or any other entity of The Bank of New York Mellon Group be liable for any Losses arising to the Trustee or any other entity of The Bank of New York Mellon Group receiving or transmitting any data from the Issuer, any Authorised Person or any party to the transaction via any non-secure method of transmission or communication, such as, but without limitation, by facsimile or email. The parties hereto accept that some methods of communication are not secure and the Trustee or any other entity of The Bank of New York Mellon Group shall incur no liability for receiving Instructions via any such non-secure method. The Trustee or any other entity of The Bank of New York Mellon Group is authorised to comply with and rely upon any such notice, Instructions or other communications believed by it to have been sent or given by an Authorised Person or an appropriate party to the transaction (or authorised representative therefore). The Issuer or any authorised officer of the Issuer shall use all reasonable endeavours to ensure that Instructions transmitted to the Trustee or any other entity of The Bank of New York Mellon Group pursuant to this Trust Deed are complete and correct. Any Instructions shall be conclusively deemed to be valid Instructions from the Issuer or any authorised officer of the Issuer to the Trustee or any other entity of The Bank of New York Mellon Group for the purposes of this Trust Deed. In this Clause, the following terms shall have the following meanings: "Authorised Person" means any person who is designated in writing by the Issuer from time to time to give instructions to the Trustee under the terms of this Trust Deed; "Instructions" means any written notices, directions or instructions received by the Trustee from an Authorised Person or from a person reasonably believed by the Trustee to be an Authorised Person: "Losses" means any and all claims, losses, liabilities, damages, costs, expenses and judgements (including legal fees and expenses) sustained by either party; and "The Bank of New York Mellon Group" means The Bank of New York Mellon and any company or other entity of which The Bank of New York Mellon is directly or indirectly a shareholder or owner. For the purposes of this Trust Deed, each branch of The Bank of New York Mellon shall be a separate member of The Bank of New York Mellon Group. 20 Purchase or Redemption by the Issuer of Shares 20.1 The Issuer may exercise such rights as it may from time to time enjoy to purchase or redeem Shares without the consent of the Bondholders. 21 Governing Law and Jurisdiction 21.1 Governing Law: This Trust Deed and any non-contractual obligations arising out of or in connection with it shall be governed by and construed in accordance with English law. 28 21.2 Jurisdiction: The courts of England are to have jurisdiction to settle any disputes which may arise out of or in connection with this Trust Deed or the Bonds (and any non- contractual obligations arising out of or in connection with them) and accordingly any legal action or proceedings arising out of or in connection with this Trust Deed or the Bonds ("Proceedings") may be brought in such courts. The Issuer irrevocably submits to the jurisdiction of such courts and waive any objections to Proceedings in such courts on the ground of venue or on the ground that the Proceedings have been brought in an inconvenient forum. This submission is for the benefit of each of the Trustee and the Bondholders and shall not limit the right of any of them to take Proceedings in any other court of competent jurisdiction nor shall the taking of Proceedings in any one or more jurisdictions preclude the taking of Proceedings in any other jurisdiction (whether concurrently or not). 21.3 Service of Process: The Issuer irrevocably appoints Process Agent Limited at its registered office for the time being currently at Kemp House, 152-160 City Road, London EC1V 2NX as its authorised agent for service of process in England in relation to Proceedings. Nothing in this Deed shall affect the right to serve process in any other manner permitted by law. 22 Counterparts This Trust Deed and any trust deed supplemental hereto may be executed in any number of counterparts, and by each party on separate counterparts. Each counterpart is an original, but all counterparts shall together constitute one and the same instrument. Delivery of a counterpart of this Trust Deed or any trust deed supplemental hereto by email attachment or telecopy shall be an effective mode of delivery. 23 Contracts (Rights of Third Parties) Act 1999 A person who is not a party to this Trust Deed has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Trust Deed except and to the extent (if any) that this Trust Deed expressly provides for such Act to apply to any of its terms. Subject to the provisions of this Trust Deed, the parties to this Trust Deed shall have the right to amend, vary or rescind any provision of this Trust Deed without the consent of any such third party. 24 Power of Attorney If the Issuer is represented by an attorney or attorneys in connection with the signing and/ or execution and/or delivery of this Trust Deed, the Global Bonds, the Definitive Registered Bonds or any agreement or document referred to herein or made pursuant hereto and the relevant power or powers of attorney is or are expressed to be governed by the laws of a particular jurisdiction, it is hereby expressly acknowledged and accepted by the other parties to this Trust Deed that such laws shall govern the existence and extent of such attorney's or attorneys' authority and the effects of the exercise thereof. 29 SCHEDULE 1 Terms and Conditions of the Bonds 1 General 1.1 Description Each Bond evidenced by this certificate is one of a duly authorised issue of debt securities of Pharming Group N.V., a limited liability company (naandoze vennootschap) incorporated under the laws of The Netherlands (the "Issuer"), designated as its €125,000,000 3.00 per cent. convertible bonds due 2025 (the "Bonds", which expression shall include any Further Bonds issued pursuant to Section 15.6). The Bonds will mature on 21 January 2025 (the "Maturity Date"). The Bonds are issued in registered form in denominations of €100,000 each. The Bonds are constituted by a Trust Deed (the "Trust Deed") dated 21 January 2020 between the Issuer and BNY Mellon Corporate Trustee Services Limited (the "Trustee" which expression shall include all persons for the time being the trustee or trustees under the Trust Deed) as trustee for the holders of the Bonds. The Issuer has also entered into a paying, transfer and conversion agency agreement (the "Agency Agreement") dated 21 January 2020 with The Bank of New York Mellon, London Branch, as principal paying, transfer and conversion agent (the "Principal Paying, Transfer and Conversion Agent") and The Bank of New York Mellon SAiNV, Luxembourg Branch as registrar in respect of the Bonds (the "Registrar") and the other paying and conversion agents named therein (the "Conversion Agents" and, together with the Principal Paying, Transfer and Conversion Agent and the Registrar, collectively, the "Agents", which term shall include their successors and assigns of any such Agent as the context requires). The holders of the Bonds are entitled to the benefit of, are bound by, and are deemed to have notice of, all the provisions of the Trust Deed and are deemed to have notice of those provisions applicable to them under the Agency Agreement. The Issuer has also entered into a calculation agency agreement dated 21 January 2020 (the "Calculation Agency Agreement") with Conv-Ex Advisors Limited (the "Calculation Agent", which expression shall include any successor as calculation agent under the Calculation Agency Agreement) whereby the Calculation Agent has been appointed to make certain calculations in relation to the Bonds. Copies of the Trust Deed, Agency Agreement and Calculation Agency Agreement are available for inspection (i) by holders of the Bonds during usual office hours at the office of the Trustee at One Canada Square, London E 14 5AL, United Kingdom, and at the specified offices of the Principal Paying, Transfer and Conversion Agent and the Registrar and (ii) electronically from the Principal Paying, Transfer and Conversion Agent upon request to corpsov2@bnymellon.com. 1.2 Definitions Capitalised terms used herein are defined in Section 14. Capitalised terms used hut not defined in these terms and conditions (these "Conditions") shall have the meanings attributed to them in the Trust Deed unless the context requires otherwise or unless otherwise stated. 2 Status of the Bonds and Negative Pledge 2.1 Status
30 The Bonds constitute direct, unconditional, unsubordinated and (subject to Section 2.2) unsecured obligations of the Issuer and shall at all times rank pari passe and without preference among themselves and at least equally with all other unsecured and unsubordinated obligations of the Issuer, present and future (subject to any obligations preferred by mandatory provisions of law). 2.2 Negative Pledge So long as any Bond remains outstanding (as defined in the Trust Deed), the Issuer will not, and will ensure that none of its Subsidiaries will, create or have outstanding any mortgage, charge, lien, pledge or other security interest, upon the whole or any part of their respective present or future undertaking, assets or revenues (including any uncalled capital) to secure any Capital Markets Indebtedness or to secure any guarantee or indemnity in respect of any Capital Markets Indebtedness, without at the same time or prior thereto providing the Bonds with the same security as is created or subsisting to secure any such Capital Markets Indebtedness, guarantee or indemnity or such other security as either (i) the Trustee shall in its absolute discretion deem not materially less beneficial to the interests of the Bondholders or (ii) shall be approved by an Extraordinary Resolution of the Bondholders. In this Section 2.2, "Capital Markets Indebtedness" means any present or future indebtedness (whether being principal, interest or other amounts) which is in the form of, or represented or evidenced by, bonds, notes, debentures, loan stock or other similar securities, whether issued for cash or in whole or in part for a consideration other than cash, which for the time being are, or are intended to be or capable of being, quoted, listed or dealt in or traded on any stock exchange or over-the- counter or other securities market. 3 Payments 3.1 Principal Unless previously redeemed, converted or purchased and cancelled as provided herein, the principal amount of each Bond will be payable on the Maturity Date. The amount due in respect of each Bond on the Maturity Date shall be 100 per cent. of its principal amount (the "Redemption Price"). 3.2 Interest (a) Generally The Bonds bear interest from and including the Closing Date at a rate of 3.00 per cent. per annum, payable semi-annually in arrear in equal instalments on 21 January and 21 July in each year and on the Maturity Date (each an "Interest Payment Date"), commencing on 21 July 2020. The interest payable on each Interest Payment Date will be the interest accrued (a) in respect of the interest period commencing on the Closing Date, from and including the Closing Date to but excluding such Interest Payment Date; and (b) in respect of each subsequent interest period, from and including the most recent prior Interest Payment Date to which interest on the Bonds has been fully paid or duly provided for, to but 31 excluding such Interest Payment Date (each, an "Interest Period"). The amount of interest payable in respect of a Bond for any period (a "Short Period") which is shorter than an Interest Period shall be calculated on the basis of the number of days in such Short Period from (and including) the first day of such Short Period to (but excluding) the last day of such Short Period divided by the product of (x) the number of days from (and including) the first day of such Short Period to (but excluding) the Interest Payment Date falling after the first day of such Short Period and (y) the number of Interest Periods normally ending in ally year. (b) Accrued Interest In respect of any Bonds for which a Conversion Notice has been given, interest shall cease to accrue with effect from the Interest Payment Date immediately preceding the relevant Conversion Date (or, if none. the Closing Date) and, subject as provided below, no interest shall be paid on such Bonds in respect of any period commencing on or after such Interest Payment Date (or, as the case may be, the Closing Date). In respect of Bonds for which the Issuer has given a Redemption Notice and subsequently Conversion Rights have been exercised, interest shall accrue at the rate provided in Section 3.2(a) above to but excluding the Conversion Date if the Redemption Notice is given on or after the 15th Business Day prior to a Dividend Determination Date in respect of any Cash or Stock Dividend on the Shares, and the redemption date specified in such notice falls on or prior to 14 Business Days after the first Interest Payment Date following such Dividend Determination Date. The Issuer shall pay any such interest by not later than 14 days after the relevant Conversion Date by transfer to a euro account with a bank in a city in which banks have access to the TARGET System in accordance with instructions given by the relevant Bondholder in the relevant Conversion Notice. However, no such interest shall be paid if the relevant Cash or Stock Dividend on the Shares has resulted in an adjustment to the Conversion Price and which is applicable to the relevant exercise of Conversion Rights. Where a Bond is redeemed pursuant to Section 4.1, 4.2 or 4.3, interest on such Bond will accrue up to, but excluding, the due date for redemption thereof unless payment of principal is improperly withheld or refused, in which event interest will continue to accrue at the rate specified in Section 3.2(a) (both before and after judgment) up to, but excluding, the Relevant Date. (c) Record Date The interest payable on any Interest Payment Date will be paid to the Person in whose name the Bonds are registered at 5:00 p.m. (local time in the place of payment) on the Record Date. In these Conditions, "Record Date" means the date falling five Business Days before the due date for any payment. 3.3 Due Date not a Business Day Notwithstanding any other provision of these Conditions or the Agency Agreement, if the date on which any principal, interest or other payment obligation is due falls on a day that is not a Business Day, the Issuer shall have until (and including) the next 32 succeeding Business Day to satisfy its payment obligation, and any such payment shall be given the same force and effect as if made on the date on which such principal, interest or other payment obligation was due. Bondholders shall not be entitled to any further interest or other payments for such delay. 3.4 Overdue Payment Obligations Any overdue principal of or interest on the Bonds, or any other overdue amount on any payment obligation hereunder, will bear interest payable on demand at a rate per annum equal to the rate specified in Section 3.2(a) above but not less than zero, from and including the date of default to but excluding the date when paid. 3.5 Fiscal Laves and FATCA All payments in respect of the Bonds are subject in all cases (i) to any applicable fiscal or other laws and regulations applicable thereto in the place of payment but without prejudice to Section 6 and (ii) any withholding or deduction required pursuant to an agreement described in Section 1471(b) of the U.S. Internal Revenue Code of 1986, as amended (the "Code"), or otherwise imposed pursuant to Sections 1471 through 1474 of the Code and any regulations or agreements thereunder or official interpretations thereof ("FATCA") or any law implementing an intergovernmental approach to FATCA ("FATCA Withholding"). 4 Redemption 4.1 Redemption at the Option of the Issuer On giving not less than 30 nor more than 60 days' notice (an "Optional Redemption Notice") to the Bondholders in accordance with Section 15.7 and to the Principal Paying, Transfer and Conversion Agent and the Trustee, the Issuer may elect to redeem all but not some only of the Bonds on the date (the "Optional Redemption Date") specified in the Optional Redemption Notice at the Redemption Price, together with accrued but unpaid interest up to (but excluding) the Optional Redemption Date: (a) at any time on or after 13 February 2023, if the Parity Value on each of at least 20 dealing days in any period of 30 consecutive dealing days ending not more than five Business Days prior to the giving of the relevant Optional Redemption Notice, shall have equalled or exceeded €130,000, as verified by the Calculation Agent; or (b) at any time following the date on which Conversion Rights become exercisable if, prior to the date the relevant Optional Redemption Notice is given, Conversion Rights shall have been exercised and/or purchases (and corresponding cancellations) and/or redemptions effected in respect of 85 per cent. or more in principal amount of the Bonds originally issued (which shall for this purpose include any Further Bonds). 4.2 Redemption for Taxation Reasons At any time the Issuer may, having given not less than 30 nor more than 60 days' notice (a "Tax Redemption Notice") to the Bondholders in accordance with Section 15.7 and to the Principal Paying, Transfer and Conversion Agent and the Trustee, redeem (subject 33 to the second following paragraph) all but not some only of the Bonds outstanding on the date (the "Tax Redemption Date") specified in the Tax Redemption Notice at the Redemption Price plus accrued interest to but excluding the Tax Redemption Date, if (a) the Issuer satisfies the Trustee immediately prior to the giving of such notice that the Issuer has or will become obliged to pay additional amounts in respect of payments of interest on the Bonds pursuant to Section 6 as a result of any change in, or amendment to, the laws or regulations of any Taxing Jurisdiction or any political subdivision or any authority thereof or therein having power to tax, or any change in the general application or official interpretation of such laws or regulations, which change or amendment becomes effective on or after 14 January 2020, and (b) such obligation cannot be avoided by the Issuer taking reasonable measures available to it, provided that no such notice of redemption shall be given earlier than 90 days prior to the earliest date on which the Issuer would be obliged to pay such additional amounts were a payment in respect of the Bonds then due. Prior to the publication of any notice of redemption pursuant to this paragraph, the Issuer shall deliver to the Trustee (1) a certificate signed by a member of the board of management (lid van de raad van bestuur) of the Issuer stating that the Issuer is entitled to effect such redemption and setting forth a statement of facts showing that the conditions precedent to the right of the Issuer so to redeem have occurred, and (2) an opinion of independent legal or tax advisers of recognised standing to the effect that such change or amendment has occurred and that the Issuer has or will become obliged to pay such additional amounts as a result thereof (irrespective of whether such amendment or change is then effective). On the Tax Redemption Date the Issuer shall (subject to the next following paragraph) redeem the Bonds at the Redemption Price, together with accrued interest up to (but excluding) the Tax Redemption Date. If the Issuer gives a Tax Redemption Notice, each Bondholder will have the right to elect that its Bonds shall not be redeemed and that the provisions of Section 6 shall not apply in respect of any payment of interest to be made on such Bonds which falls due after the relevant Tax Redemption Date, whereupon no additional amounts shall be payable in respect thereof pursuant to Section 6 and payment of all amounts of such interest on such Bonds shall be made subject to the deduction or withholding of any taxation in the relevant Taxing Jurisdiction required to be withheld or deducted. To exercise such right, the holder of the relevant Bond must complete, sign and deposit at the specified office of the Principal Paying, Transfer and Conversion Agent or any Conversion Agent, a duly completed and signed notice of election. in the form for the time being current, obtainable from the specified office of the Principal Paying, Transfer and Conversion Agent or any Conversion Agent together with the relevant Bonds on or before the day falling 10 days prior to the Tax Redemption Date. Any Bond so deposited shall be returned by the relevant Paying, Transfer and Conversion Agent or Conversion Agent to the relevant Bondholder on the Tax Redemption Date, endorsed to reflect the election made by such Bondholder, by uninsured post to. and at the risk of, the relevant Bondholder. 4.3 Redemption at the Option of Bondholders upon a Put Event Following the occurrence of a Put Event, the holder of each Bond will have the right to require the Issuer to redeem that Bond on the Put Date at its Redemption Price, plus accrued interest to but excluding the Put Date. To exercise such right, the holder of the relevant Bond must deliver such Bond to the specified office of the Principal Paying, Transfer and Conversion Agent or any Conversion Agent, together with a duly completed
34 and signed notice of exercise in the form for the time being currently obtainable from the specified office of the Principal Paying, Transfer and Conversion Agent or any Conversion Agent (a "Put Exercise Notice"), at any time during Put Period. The "Put Date" shall be the fourteenth calendar day after the expiry of the Put Period. Payment in respect of any such Bond shall be made by transfer to a euro account with a bank in a city in which banks have access to the TARGET System as specified by the relevant Bondholder in the relevant Put Exercise Notice. A Put Exercise Notice, once delivered, shall be irrevocable and the Issuer shall redeem all Bonds the subject of Put Exercise Notices delivered as aforesaid on the Put Date. Within 14 calendar days following the occurrence of a Put Event, the Issuer shall give notice thereof to the Bondholders in accordance with Section 15.7 (a "Put Notice"). The Put Notice shall contain a statement informing Bondholders of their entitlement to exercise their Conversion Rights, as provided in these Conditions and their entitlement to exercise their rights to require redemption of their Bonds pursuant to this Section 4.3. The Put Notice shall also specify: (a) all information material to Bondholders concerning the Put Event; (b) the Conversion Price immediately prior to the occurrence of the Put Event and, if applicable, the Change of Control Conversion Price applicable pursuant to Section 5.4(c) during the Put Period on the basis of the Conversion Price in effect immediately prior to the occurrence of the Chance of Control; (c) the Closing Price of the Shares as at the latest practicable date prior to the publication of the Put Notice; (d) the Put Period; (e) the Put Date; and (f) such other information relating to the Put Event as the Trustee may reasonably require. The Trustee shall not be required to monitor or take any steps to ascertain whether a Put Event or any event which could lead to a Put Event has occurred or may occur and will not be responsible or liable to Bondholders or any other person for any loss arising from any failure by it to do so. 4.4 Redemption Notices Any Redemption Notice shall be irrevocable. Any such notice shall specify (i) the Optional Redemption Date or the Tax Redemption Date, as the case may be, which shall be a Business Day, (ii) the Conversion Price, the aggregate principal amount of the Bonds outstanding and the Closing Price of the Shares, in each case as at the latest practicable date prior to the publication of the Redemption Notice and (iii) the last day on which Conversion Rights may be exercised by Bondholders. 35 5 Conversion Rights 5.1 Conversion Rights and Conversion Price Subject as provided in these Conditions, each Bond shall entitle the Bondholder to convert each Bond into new and/or existing Shares as determined by the Issuer, credited as fully paid ("Conversion Rights"). The number of Shares to be issued or transferred and delivered on exercise of a Conversion Right shall be equal to the Reference Shares in respect of such exercise. The Issuer will procure that Shares to be issued or transferred and delivered on exercise of Conversion Rights will be issued or transferred and delivered to the relevant Bondholder or his nominee as specified in the relevant Conversion Notice in accordance with the provisions of Section 5.3. The initial Conversion Price is €2.0028 per Share. The Conversion Price is subject to adjustment in the circumstances described in Section 5.4. The expression "Conversion Price" shall be construed accordingly. Subject to and as provided in these Conditions, the Conversion Right in respect of a Bond may be exercised, at the option of the holder thereof at any time subject to any applicable fiscal or other laws or regulations and as hereinafter provided) from the Closing Date to (and including) the date falling 7 Business Days prior to the Maturity Date (both days inclusive) or, if such Bond is to be redeemed pursuant to Section 4.1 or 4.2 prior to the Maturity Date, then up to (and including) the date falling 7 Business Days before the date fixed for redemption thereof pursuant to Section 4.1 or 4.2 unless there shall be a default in making payment in respect of such Bond on any such date fixed for redemption, in which event the Conversion Right shall extend up to the end of normal business hours (at the place aforesaid) on the date on which the full amount of such payment becomes available for payment and notice of such availability has been given to Bondholders or, if earlier, the Maturity Date or, if the Maturity Date is not a Business Day, the immediately preceding Business Day. Conversion Rights may not be exercised (i) following the giving of notice by the Trustee pursuant to Section 8 that the Bonds are immediately due and payable or (ii) in respect of a Bond in respect of which the relevant Bondholder has exercised its right to require the Issuer to redeem that Bond pursuant to Section 4.3. Conversion Rights may not be exercised by a Bondholder in circumstances where the relevant Conversion Date would fall during the period commencing on the Record Date in respect of any payment of interest on the Bonds and ending on the relevant Interest Payment Date (both days inclusive). The period during which Conversion Rights may (subject as provided herein) be exercised by a Bondholder is referred to as the "Conversion Period". 5.2 Procedures for Exercising Conversion Rights (a) Delivery of Conversion Notice on exercise of Conversion Rights 36 Subject to the terms and conditions of this Section 5.2, each Bondholder may exercise its Conversion Rights by giving at its own expense to any Conversion Agent a conversion notice (and, if required under Section 5.2(b) below, the relevant Bond certificate) substantially in the form set forth in the Agency Agreement (a “Conversion Notice"). The Business Day following the day on which such Conversion Notice shall have been received (or, if such day is not a Business Day, the following Business Day) by the Conversion Agent shall be the "Conversion Date" and shall be deemed to be the date on which Conversion Rights have been exercised. Copies of the Conversion Notice can be obtained during normal business hours at the registered office of the Conversion Agent. Shares to be delivered following an exercise of Conversion Rights will be delivered by credit to an account with a financial institution. The Bondholder must include sufficient details about the account and the financial institution in the Conversion Notice to permit the Issuer to make or to cause to be made such delivery by credit to such account. Once delivered to the Conversion Agent, a Conversion Notice will be irrevocable. Conversion Rights may only be exercised in respect of the whole of a Bond. (b) Surrender of Bond Certificates A Bondholder must surrender any certificate evidencing the Bonds being converted to the Conversion Agent on or before the Conversion Date. 5.3 Delivery of Shares (a) Delivery of Shares Where Conversion Rights shall have been exercised, the Issuer shall deliver to the relevant Bondholder or Bondholders such number of Shares as is equal to the Reference Shares in respect of such exercise, thereby satisfying by way of set off the obligation to pay up the issue price of the Shares (which issue price shall be equal to the principal amount of the Bonds to be converted). (b) Fractions Fractions of Shares will not be issued or transferred and delivered on exercise of Conversion Rights or pursuant to Section 5.4(f) and no cash payment or other adjustment will be made in lieu thereof. However, if the Conversion Right in respect of more than one Bond is exercised at any one time such that Shares to be issued or transferred and delivered on conversion or pursuant to Section 5.4(f) are to be registered in the same name, the number of such Shares to be issued or transferred and delivered in respect thereof shall be calculated by the Calculation Agent on the basis of the aggregate principal amount of such Bonds being so converted and rounded down to the nearest whole number of Shares. (c) Procedures for Delivery of Shares Following the exercise of Conversion Rights by a Bondholder, the issuer shall deliver, or procure the delivery of the Reference Shares (if any) on the relevant 37 Delivery Date to the relevant Bondholder by crediting the account with the financial institution specified in the relevant Conversion Notice with the Reference Shares. All Shares delivered to Bondholders on exercise of Conversion Rights will be fully paid and non-assessable on the relevant Delivery Date. In these Conditions, "non- assessable" (which term has no equivalent in Dutch) means that neither the Issuer nor any other Person has any right to require the holder of a Share to pay to the Issuer or any other Person any additional or further amount solely as a result of its holding of such Share. "Delivery Date" means the date on which the relevant Reference Shares are issued and/or delivered to the relevant Bondholder, which shall be no later than the date falling five Business Days following the relevant Conversion Date. (d) Settlement Disruption Event If a Settlement Disruption Event occurs between the Conversion Date and the Delivery Date, and delivery of any Shares cannot be effected on the Delivery Date, then solely for purposes of this Section 5.3 the Delivery Date will be postponed until the first succeeding calendar day on which delivery of the Shares can take place through a national or international settlement system or in any other commercially reasonable manner. (e) No Payment or Adjustment for Accrued Dividends Shares delivered to Bondholders on exercise of their Conversion Rights will rank pari passu in all respects with the fully paid Shares in issue on the relevant Delivery Date, except that Bondholders will not be entitled to receive any dividend or other distribution declared payable to holders of Shares by reference to a record date falling prior to such Delivery Date. No interest or other amount or adjustment will be paid or made in respect of any such dividend or dividends. (f) Ranking Where a Bondholder shall have exercised its Conversion Rights. the relevant Bondholder shall he entitled to all dividends, distributions and other entitlements of the Shares determined by reference to a record date on or after the relevant Delivery Date. 5.4 Adjustment of Conversion Price (a) Non-Merger Events The Conversion Price will he adjusted by (unless otherwise specified) the Calculation Agent as follows under the following circumstances (each, an "Adjustment Event"): (i) Stock Split or Consolidation If there shall have occurred a subdivision or consolidation of the Shares (except for a Merger Event) into a greater or lesser number of Shares, the
38 Conversion Price will be adjusted as of the Effective Date by multiplying the Conversion Price in effect immediately prior to the Effective Date by Formula 1 in Section 5.4(b) below. "Effective Date" means, in respect of this Section 5.4(a)(i), the date on which such subdivision or consolidation takes effect. (ii) Granting of Rights or Warrants for Shares If the Issuer grants or causes to be granted a right, warrant or other security to existing holders of Shares as a class giving them the right to purchase or subscribe for additional Shares (other than constituting a Cash or Stock Dividend), the Conversion Price will be adjusted as of the Effective Date by multiplying the Conversion Price in effect immediately prior to the Effective Date by Formula 2 in Section 5.4(b) below. "Effective Date" means, in respect of this Section S.4(a)(ii), the later of (i) the Ex-Date in respect of such grant and (ii) the first date on which the result of Formula 2 in Section 5.4(b) below is capable of being determined in accordance with such Formula (iii) Sale of Shares at a Substantial Discount If the Issuer issues Shares for no consideration or sells Shares for cash, or causes Shares to be sold for cash, for a price that is less than 95 per cent. of the Current Market Price for the Shares on the date of first public announcement of the terms of such sale (other than in the circumstances the subject of Section 5.4(a)(ii) or 5.4(a)(iv), and other than constituting a Cash or Stock Dividend), the Conversion Price will be adjusted as of the Effective Date by multiplying the Conversion Price in effect immediately prior to the Effective Date by Formula 3 in Section 5.4(h) below. "Effective Date" means, in respect of this Section 5.4(a)(iii), the date of issuance of the Shares. (iv) Free Distributions of Shares If the Issuer makes or causes to be made a free distribution of Shares by way of capitalisation of profits or reserves to existing holders of Shares as a class (other than constituting a Cash or Stock Dividend), the Conversion Price will be adjusted as of the Effective Date by multiplying the Conversion Price in effect immediately prior to the Effective Date by Formula 1 in Section 5.4(h) below. "Effective Date" means, in respect of this Section 5.4(a)(iv), the Ex-Date in respect of such distribution. (v) Free Distribution of an Equity-Linked Security If the issuer makes or causes to be made a free distribution or dividend of securities that are convertible, exchangeable or otherwise exercisable into 39 the Shares to existing holders of Shares as a class (other than in the circumstances the subject of Section 5.4(a)(ii) and other than constituting a Cash or Stock Dividend), the Conversion Price will be adjusted as of the Effective Date by multiplying the Conversion Price in effect immediately prior to the Effective Date by Formula 2 in Section 5.4(b) below. "Effective Date" means, in respect of this Section 5.4(a)(v), the later of (1) the Ex-Date in respect of such free distribution or dividend and (ii) the first date on which the result of Formula 2 in Section 5.4(h) below is capable of being determined in accordance with such Formula 2. (vi) Granting of Rights or Warrants for an Equity-Linked Security If the issuer grants or causes to be granted a right, warrant or other security to existing holders of Shares as a class giving them the right to purchase or subscribe for securities that are convertible, exchangeable or otherwise exercisable into the Shares, (other than in the circumstances the subject of Section 5.4(a)(v) and other than constituting a Cash or Stock Dividend) the Conversion Price will be adjusted as of the Effective Date by multiplying the Conversion Price in effect immediately prior to the Effective Date by Formula 2 in Section 5.4(h) below. "Effective Date" means, in respect of this Section 5.4(a)(vi), the later of (i) Ex-Date in respect of such grant and (ii) the first date on which the result of Formula 2 in Section 5.4(h) below is capable of being determined in accordance with such Formula 2. (vii) Issuance of Equity-Linked Securities at a Substantial Discount If the Issuer issues for no consideration or issues and sells for cash, or causes to be issued and sold for cash, securities that are convertible, exchangeable or otherwise exercisable into, or grants rights or options to purchase or subscribe, Shares (other than in the circumstances the subject of Section 5.4(a)(v) or Section 5.4(a)(vi) and other than constituting a Cash or Stock Dividend) and the price per equity-linked security, right or option (determined on a per Share basis by reference to the initial conversion or exchange price or ratio) together with any other consideration received or receivable by the Issuer in respect of such equity-linked security, right or option (determined on a per Share basis as aforesaid) is less than 95 per cent. of the Current Market Price for the Shares on the date of first public announcement of the terms of such equity-linked securities, rights or options, the Conversion Price will be adjusted as of the Effective Date by multiplying the Conversion Price in effect immediately prior to the Effective Date by Formula 3 in Section 5.4(b) below. "Effective Date" means, in respect of this Section 5.4(a)(vii), the date of issuance of such equity-linked security. (viii) Granting of Rights or Warrants for other Property 40 If the Issuer grants a right, warrant or other security to existing holders of Shares as a class giving them the right to purchase at less than Fair Market Value (determined as at the Ex-Date in respect of such grant), any other property (not covered by another Section of this Section 5.4(a), and other than constituting a Cash or Stock Dividend), the Conversion Price will be adjusted as of the Effective Date by multiplying the Conversion Price in effect immediately prior to the Effective Date by Formula 2 in Section 5.4(h) below. "Effective Date" means, in respect of this Section 5.4(a)(viii), the later of (i) Ex-Date in respect of such grant and (ii) the first date on which the result of Formula 2 in Section 5.4(h) below is capable of being determined in accordance with such Formula 2. (ix) Cash or Stock Dividend If a Cash or Stock Dividend is paid or made on the Shares, where the Ex- Date in respect of such Cash or Stock Dividend falls on or after the Closing Date, then the Conversion Price will be adjusted as of the Effective Date, by multiplying the Conversion Price in effect immediately prior to the Effective Date by Formula 5 in Section 5.4(h) below. "Effective Date" means, in respect of this Section 5.4(a)(ix), the later of (i) Ex-Date in respect of such Cash or Stock Dividend and (ii) the first date on which the result of Formula 5 in Section 5.4(b) below is capable of being determined in accordance with such Formula 5. (x) Spin-off or Subdivision of Shares into Classes If the Issuer distributes, or causes to be distributed, to existing holders of Shares (a "Spin-off Event") equity securities of any entity other than the Issuer (the "Spin-off Securities"), or subdivides (a "Reclassification") the Shares into two or more separately quoted classes of equity securities (such new classes of equity securities, the "Reclassified Securities"), then one of the following adjustments will be made (as appropriate and subject as provided therein), as selected by the Issuer (in consultation with an Independent Adviser) from among the options applicable to such event, effective as of the Effective Date: (1) in the case of a Spin-off Event or a Reclassification where the Spin- off Securities or Reclassified Securities, as the case may be, are publicly traded on a Recognised Exchange, the Shares shall thereafter comprise the securities comprising either the Shares immediately prior to such adjustment together with the Spin-off Securities (in the case of a Spin-off Event) or the Reclassified Securities (in the case of a Reclassification), in either case in the same amount as the Bondholder would have been entitled to receive had he converted the Bonds into Shares immediately prior to the record date of such Spin-off Event or the effective date of such Reclassification; 41 (2) in the case of a Spin-off Event, the Conversion Price will be adjusted by multiplying the Conversion Price then in effect by Formula 2 in Section 5.4(b) below; (3) in the case of a Spin-off Event, where the Spin-off Securities are publicly traded on a Recognised Exchange, the Issuer will, within five dealing days after the Ex-Date in respect of the Spin-off Event, deliver the Spin-off Securities to each Bondholder in the same amount as the Bondholder would have been entitled to receive had he converted the Bonds into Shares immediately prior to the record date of such Spin-off Event; or (4) in the case of a Spin-off Event, where the Spin-off Securities are publicly traded on a Recognised Exchange, the Issuer will. within five dealing days after the Ex-Date in respect of the Spin-off Event, pay to each Bondholder an amount in cash in euros (rounded to the nearest €0.01, with €0.005 being rounded upwards) equal to the number of such Spin-off Securities as such Bondholder would have been entitled to receive had he converted the Bonds into Shares immediately prior to the record date of such Spin-off Event multiplied by the Fair Market Value of the Spin-off Securities on a per Share basis. If the Issuer selects option (1): (y) in the case of a Spin-off Event, each Bond will thereafter be convertible into the Shares and the relevant Spin-off Securities and for such purposes the initial Conversion Price in respect of such Spin-off Securities upon the relevant Spin-off Event shall be calculated by dividing the principal amount of each Bond by the number of Spin-off Securities the holder of such Bond would have been entitled to receive had he converted the Bonds into Shares immediately prior to the record date of such Spin-off Event. No adjustment shall he made to the Conversion Price in respect of the Shares as a result of such Spin-off Event. (z) in the case of a Reclassification, the Bonds will thereafter be convertible into each class of the Reclassified Securities and for such purposes the initial Conversion Price in respect of each class of Reclassified Securities upon the Reclassification shall be calculated by dividing the principal amount of each Bond by the number of such Reclassified Securities as the holder of such Bond would have been entitled to receive had he converted the Bonds into Shares immediately prior to the effective date of such Reclassification. "Effective Date" means, in respect of this Section 5.4(a)(x), the record date for such Spin-Off Event (or, as the case may be, the
42 effective date for such Reclassification) (or, if the Issuer selects option (2) and if later, the first date on which the result of Formula 2 in Section 5.4(b) below is capable of being determined in accordance with such Formula 2). If the Issuer shall select option (3) or (4) the Bonds will continue to be convertible into Shares as provided in these Conditions and no adjustment shall be made to the Conversion Price as a result of the relevant Spin-off Event. (xi) Share Buybacks by means of a Tender or Exchange Offer above Market If the Issuer or any of its Subsidiaries commences a tender or exchange offer for the Shares and the Fair Market Value of the cash and other consideration offered per Share (determined as at the Expiration Time) exceeds the value of "P" in Formula 4 in Section 5.4(b) below, the Conversion Price will be adjusted as of the Effective Date by multiplying the Conversion Price in effect immediately prior to the Effective Date by the fraction expressed by Formula 4 in Section 5.4(b) below. For the avoidance of doubt, this section does not apply to a purchase or redemption or buyback of share capital of the Issuer by or on behalf of the Issuer or any of its Subsidiaries pursuant to any general authority for such purchases, redemptions or buybacks approved by a general meeting of Shareholders and in accordance with the price limits specified in Article 3 of Commission Delegated Regulation (EU) 2016/1052 (or any successor regulation providing a safe harbour for share buybacks by an issuer under applicable market abuse rules). "Effective Date" means, in respect of this Section 5.4(a)(xi), the later of (i) the dealing day immediately following the Expiration Time (as defined below) and (ii) the first date on which the result of Formula 4 in Section 5.4(h) below is capable of being determined in accordance with such Formula 4. (b) Adjustment Formulae The formulae to be applied in Section 5.4(a) above to adjust the Conversion Price are as follows: Formula 1 (Sections 5.4(a)(i) and 5.4(a)(iv) above): X Y where: X = the number of Shares outstanding immediately prior to the occurrence of such event. 43 Y = the number of Shares outstanding immediately after the occurrence of such event. Formula 2 (Sections 5.4(a)(ii), 5.4(a)(v), 5.4(a)(vi), 5.4(a)(viii) and 5.4(a)(x)(2) above): P- d P where: P = the Current Market Price on the Ex-Date in respect of the relevant distribution, dividend, rights, warrants or other securities or other property. d = the Fair Market Value per Share of the distribution, dividend, rights, warrants or securities or other property, as the case may be, such Fair Market Value as aforesaid being determined as at the Ex-Date in respect thereof Formula 3 (Sections 5.4(a)(iii) and 5.4(a)(vii) above): X + (Z x c/ P) X+Z where: X = the number of Shares outstanding immediately prior to the date of first public announcement of the terms of the relevant issue or sale. P = the Current Market Price on the date of first public announcement of the terms of the relevant issue or sale. Z = the number of (i) Shares to be sold or (ii) Shares into which such other securities to be sold or issued are convertible, exchangeable or otherwise exercisable. c = (i) the sale price per security of the Shares to be sold or (ii) the sale price of the securities to be sold or issued that are convertible, exchangeable or otherwise exercisable into the Shares, together with any other consideration received or receivable in respect of such securities, in each case determined on a per Share basis by reference to the initial issue, sale, conversion or exchange price or ratio, as the case may be (and in any such case if the relevant Shares or securities are issued for no consideration, the sale price shall be zero). Formula 4 (Section 5.4(a)(xi) above): N1xP A + (N2 x P) where: 44 N1 = the number of Shares outstanding at the latest time (the "Expiration Time") tenders or exchanges may be made pursuant to such tender or exchange offer (as it shall have been amended), inclusive of all Shares validly tendered or exchanged and not withdrawn as of the Expiration Time (the "Purchased Shares"). N2 = the number of Shares outstanding at the Expiration Time, exclusive of any Purchased Shares. P = the Current Market Price of the Shares on the date of first public announcement of the terms of the tender or exchange offer. A = the Fair Market Value (determined as at the Expiration Time) of the aggregate consideration payable to holders of Shares based on the acceptance (up to any maximum specified in the terms of the tender or exchange offer) of the Purchased Shares. Formula 5 (Section 5.4(a)( ix ) above): P - d P P = the Current Market Price of the Shares on the Ex-Date in respect of the relevant Cash or Stock Dividend. d = the Fair Market Value of the relevant Cash or Stock Dividend per Share as at the Ex-Date in respect of such Cash or Stock Dividend. (c) Change of Control If a Change of Control occurs, the Conversion Price (the "Change of Control Conversion Price") in respect of any Bonds in respect of which Conversion Rights are exercised and the Conversion Date falls during the Change of Control Period, will be determined as set out below: COCCP = OCP/(1+ (CP x c/t)) where: COCCP = means the Change of Control Conversion Price OCP = means the Conversion Price in effect on the relevant Conversion Date CP = means 40 per cent. c = means the number of days from and including the date the Change of Control occurs to but excluding the Maturity Date t = means the number of days from and including the Closing Date to but excluding the Maturity Date (d) Merger Events 45 If, in respect of a Merger Event, the consideration for the Shares consists (or, at the option of the holder of the Shares, may consist) of New Securities, Other Consideration or Combined Consideration, then on or after the Merger Date each Bond shall be convertible into the number of New Securities, the amount of Other Consideration or the amount of Combined Consideration, as the case may be, to which a holder of the number of Shares which would have been required to be delivered had such Bond been converted immediately prior to the Merger Event would be entitled upon consummation of the Merger Event. Where pursuant to the foregoing the Bonds will be convertible into property including or comprising New Securities, the initial Conversion Price in respect of such New Securities shall be calculated by dividing the principal amount of each Bond by the number of such New Securities (determined as provided above), all as determined by an Independent Adviser. (e) Other Adjustments No adjustment to the Conversion Price will be required other than those specified above. However, if the Issuer (following consultation with the Calculation Agent) determines in good faith that an adjustment should be made to the Conversion Price (or that a determination should be made as to whether an adjustment should be made) as a result of one or more events or circumstances not referred to above in this Section 5.4 (even if the relevant event or circumstances are specifically excluded from the operation of any or all of Sections 5.4(a) and 5.4(c) above), the Issuer shall, at its own expense and acting reasonably, in consultation with the Calculation Agent, request an Independent Adviser to determine as soon as practicable what adjustment (if any) to the Conversion Price is fair and reasonable to take account of such events or circumstances and the date on which such adjustment should take effect. Upon such determination, such adjustment (if any) shall be made and shall take effect in accordance with such determination. If following consultation between the Issuer and the Calculation Agent any doubt shall arise as to the appropriate adjustment to the Conversion Price, and following consultation between the Issuer and an Independent Adviser, a written opinion of such Independent Adviser in respect thereof shall be conclusive and binding on the Issuer, the Bondholders, the Calculation Agent and the Paying, Transfer and Conversion Agents and the Conversion Agents, save in the case of manifest error. (f) Retroactive Adjustments If a Retroactive Adjustment occurs in relation to any exercise of Conversion Rights, the Issuer shall procure that there shall be issued or transferred and delivered to the relevant Bondholder, in accordance with the instructions contained in the relevant Conversion Notice, such additional number of Shares (if any) (the – "Additional Shares") as, together with the Shares issued or transferred and delivered on the relevant exercise of Conversion Rights, is equal to the number of Shares which would have been required to be issued or transferred and delivered on such exercise if the relevant adjustment to the Conversion Price had been made and become effective immediately prior to the relevant Conversion Date, all as determined in good faith by the Calculation Agent or an Independent Adviser, provided that if in the case of Section 5.4(a) (ii), (iv), (v), (vi), (vii) or (ix) the relevant Bondholder shall be entitled to receive the relevant Shares, Cash or Stock
46 Dividends, securities or Securities in respect of the Shares to be issued or transferred and delivered to it, then no such Retroactive Adjustment shall be made in relation to the relevant event and the relevant Bondholder shall not be entitled to receive Additional Shares in relation thereto. (g) No Adjustment Other than an adjustment to the Conversion Price in respect of a consolidation of Shares pursuant to Section 5.4(a)(i), no adjustment to the Conversion Price shall result in an increase thereof. No adjustment to the Conversion Price will be made to the extent that the Conversion Price for one Share would thereby be reduced below the nominal amount of each Share effective as of the date of such adjustment. Without prejudice to the foregoing, upon any event which, but for this Section 5.4(g), would result in an adjustment to the Conversion Price to an amount which is less than the nominal amount of each Share, in accordance with the foregoing provisions, the calculation of any subsequent adjustments will be made on the amount of the Conversion Price which would have resulted, had this Section 5.4(g) not applied. If the result of such adjustments is below the nominal amount per Share, the Conversion Price will be equal to the nominal amount of each Share. To the extent that an adjustment to the Conversion Price cannot occur as a result of this Section 5.4(g), the Issuer will not be obliged to compensate the Bondholders by a cash payment or in any other way. (h) Procedures Adjustments to the Conversion Price shall be determined and calculated by the Calculation Agent upon request from the Issuer and/or, to the extent so specified in the Conditions and upon request from the Issuer, by an Independent Adviser. Adjustments to the Conversion Price calculated by the Calculation Agent or, where applicable, an Independent Adviser and any other determinations made by the Calculation Agent or, where applicable, an Independent Adviser, or an opinion of an Independent Adviser, pursuant to these Conditions shall in each case be made in good faith and shall be final and binding (in the absence of manifest error) on the Issuer, the Trustee, the Bondholders, the Calculation Agent (in the case of a determination by an Independent Adviser), the Paying, Transfer and Conversion Agents and the Conversion Agents. The Calculation Agent may consult, at the expense of the Issuer, on any matter (including, but not limited to, any legal matter) relating to the performance of its obligations in respect of the Bonds, any legal or other professional adviser as it reasonably believes is necessary and it shall be able to rely upon, and it shall not be liable and shall incur no liability as against the Trustee, the Bondholders, the Conversion Agents or the Paying, Transfer and Conversion Agents in respect of anything done, or omitted to be done, relating to that matter in good faith, in accordance with that adviser's opinion. The Calculation Agent shall act solely upon the request from, and exclusively as agent of. the Issuer and in accordance with these Conditions. Neither the 47 Calculation Agent (acting in such capacity) nor any Independent Adviser appointed in connection with the Bonds (acting in such capacity) will thereby assume any obligations towards or relationship of agency or trust and shall not be liable and shall incur no liability in respect of anything done, or omitted to be done in good faith, in its capacity as Calculation Agent as against the Trustee, the Bondholders, the Conversion Agents or the Paying Transfer and Conversion Agents. All references in the foregoing provisions to the number of Shares outstanding shall exclude Shares held by or on behalf of the Issuer or any Subsidiary. The Conversion Price resulting from any adjustment provided for in Section 5.4(a), 5.40 or 5.4(e) above will be rounded down to the nearest 0.0001, subject to Section 5.4(i). (i) De Minimis Exception No adjustment to the Conversion Price pursuant to Sections 5.4(a), 5.40 and 5.4(e) above will be made if the adjustment (rounded down if applicable) would result in a change in the Conversion Price of less than 1 per cent. of the then prevailing Conversion Price, provided that any adjustment that would otherwise be required to be made and any amount by which the Conversion Price has been rounded down pursuant to Section 5.4(i) above will be carried forward and taken into account in any subsequent adjustment. and such subsequent adjustment shall be made on the basis that the adjustment not required to be made had been made at the relevant time and/or, as the case may be, that the roles ant rounding down had not been made. (j) Notice The Issuer shall give notice to the Principal Paying, Transfer and Conversion Agent, the Trustee and the Bondholders in accordance with Section 15.7 of any change (or, at the Issuer's discretion, any prospective change) to the Conversion Price as soon as reasonably practicable following such change (or, if the notice is given in respect of a prospective change, at such time as the Issuer shall determine). (k) Share or Option Schemes, Dividend Reinvestment Plans No adjustment will be made to the Conversion Price pursuant to this Section 5.4 where Shares or other securities (including, hut not limited to. rights, warrants and options) are issued, offered, exercised, allotted, purchased, appropriated, modified or granted to, or for the benefit of, employees or former employees (including directors holding or formerly holding executive office or non-executive office, consultants or former consultants or the personal service company of any such person) or their spouses or relatives, in each case, of the Issuer or any of its Subsidiaries or any associated company or to a trustee or nominee to be held for the benefit of any such person, in any such case pursuant to any share or option or incentive scheme or pursuant to any dividend reinvestment plan or similar plan or scheme. 5.5 Stamp, Transfer, Registration or other Taxes or Duties 48 The Issuer shall pay all stamp, issue, registration, transfer, documentary and other similar taxes or duties payable in The Netherlands, or in any other jurisdiction in which the Issuer may be, from time to time, domiciled, resident or otherwise has a taxable presence upon delivery of Shares on exercise of Conversion Rights ("Transfer Takes"). If the issuer shall fail to pay any Transfer Taxes, the relevant Bondholder shall be entitled to pay any such Transfer Taxes and the Issuer as a separate and independent stipulation, covenants to reimburse and indemnify each Bondholder in respect of any payment thereof and any penalties payable in respect thereof. A Bondholder exercising Conversion Rights must pay directly to the relevant authorities any capital, stamp, issue, registration, transfer and other taxes or duties arising on the exercise of such Conversion Rights, other than any Transfer Taxes. A Bondholder must also pay all, if any, taxes imposed on it and arising by reference to any disposal or deemed disposal by it of a Bond or interest therein in connection with the exercise of Conversion Rights by it. Any duties or taxes payable by a Bondholder pursuant to this Section 5.5 in the jurisdiction of the Conversion Agent with whom the relevant Conversion Notice is deposited shall be required to be paid to such Conversion Agent as a condition precedent to conversion. None of the Issuer, the Trustee or any Agent will impose any charge upon the exercise of Conversion Rights. 5.6 Repurchase of Bonds The Issuer and any Subsidiary may at any time purchase Bonds at any price in the open market or in privately negotiated transactions, provided that such purchases are in compliance with applicable law and stock exchange regulations. All Bonds which are so purchased will promptly be cancelled and may not be reissued or resold. 5.7 Calculation of Damages Subject to applicable law and Condition 8, if the Issuer fails to deliver Shares upon an exercise of Conversion Rights, for the purposes of any damages claim, the value of the relevant claim shall be calculated on the basis of the Volume Weighted Average Price of a Share on the relevant Delivery Date. 6 Withholding Taxes All payments of principal, interest and other amounts made by the Issuer in respect of the Bonds will be made without deduction or withholding for, or on account of, any present or future taxes, duties, assessments or governmental charges of whatever nature imposed or levied, collected, withheld or assessed by or on behalf of the jurisdiction in which the Issuer is resident for tax purposes (a "Taxing Jurisdiction"), unless the withholding or deduction of such taxes, duties, assessments or governmental charges is required by law or regulation or by the official interpretation thereof. In that event, the Issuer will pay such additional amounts (the "Additional Amounts") as will result in the receipt by the Bondholders of the amounts which would have been received by them had no such withholding or deduction been required, except that no such Additional Amounts shall be payable on account of any taxes or duties which: 49 (a) are payable by reason of the Bondholder having, or having had, some personal or business connection with such Taxing Jurisdiction other than a connection arising from the mere holding of the Bond or receiving payments in respect of the Bond; (b) are made in regard to any FATCA Withholding; or (c) (with effect from 1 January 2021 only) are payable pursuant to the Dutch Withholding Tax Act 2021 (Wet bronbelasting 2021) (the "Act") by reason of the Bondholder being related (gelieerd) to the Issuer within the meaning of the Act. References in these Conditions to principal and/or interest and "or any other amounts payable in respect of the Bonds shall be deemed also to refer to any Additional Amounts which may be payable under this Section 6. The provisions of this Section 6 shall not apply in respect of any payments of interest which fall due after the relevant Tax Redemption Date in respect of any Bonds which are the subject of a Bondholder election pursuant to Section 4.2. 7 Covenants So long as any Bond remains outstanding, save with the approval of an Extraordinary Resolution or with the prior written approval of the Trustee where, in its opinion, it is not materially prejudicial to the interest of the Bondholders to give such approval: (a) Covenant not to Merge, Consolidate, Amalgamate. Sell, Lease or Transfer Assets under Certain Conditions: The Issuer will not consolidate or amalgamate with or merge into any other corporation or corporations (other than where the Issuer is the continuing entity), or sell, lease, or transfer all or substantially all its assets, unless (A) the corporation formed by such consolidation or amalgamation, or into which the Issuer shall have been merged, or which shall have acquired such assets upon any such sale, lease or transfer shall have expressly assumed the due and punctual payment of the principal of and interest on all the Bonds and the due and punctual performance and observance of all of the covenants and conditions of the Bonds to be performed or observed by the Issuer and (B) (x) each Bond shall thereafter be convertible into the class and amount of Shares and other securities, property and assets (including cash) receivable upon such consolidation, amalgamation or merger or sale, lease or transfer by a holder of the number of Shares which would have been required to be delivered had such Bond been converted into Shares immediately prior to such merger, consolidation, amalgamation, sale, lease or transfer or (y) if, in the case of any such sale, lease or transfer, no such Shares or other securities, property or assets are receivable by holders of Shares, the Bonds will be convertible into Shares or common stock or the like (comprising equity securities) of the corporation which shall have acquired the relevant assets on such basis and with a Conversion Price (subject to adjustment as provided in these Conditions) as determined in good faith by an Independent Adviser. For the purposes thereof, the Issuer shall execute and deliver to each of the Agents a supplement to the Agency Agreement satisfactory to the Principal Paying, Transfer and Conversion Agent. Such supplement will provide for adjustments which will be as nearly equivalent as may be practicable to the adjustments provided for in these Conditions. The provisions of this Section 7(a) will apply in the same way to any subsequent merger, consolidation,
50 amalgamation, sale, lease or transfer. In case of any such consolidation, merger, sale, lease or transfer, and following such an assumption by the successor corporation, such successor corporation will succeed to and be substituted for the Issuer with the same effect as if it had been named herein. In the event of any such sale, lease or transfer, following such an assumption by the successor corporation. the Issuer will be discharged from all obligations and covenants under the Bonds and the Agency Agreement and may be liquidated and dissolved. (b) Covenant not to Issue or Pay Up any Securities: The Issuer will not issue or pay up any Securities, in either case by way of capitalisation of profits or reserves, other than: (i) by the issue of fully paid Shares or other Securities to Shareholders and other holders of shares in the capital of the Issuer which by their terms entitle the holders thereof to receive Shares or other Securities on a capitalisation of profits or reserves; or (ii) by the issue of fully paid Shares, issued wholly, ignoring fractional entitlements, in lieu of the whole or part of a Cash or Stock Dividend in cash; or (iii) by the issue of Shares or any equity share capital to, or for the benefit of, any employees or former employees, director or executive holding or formerly holding executive office (including directors holding or formerly holding executive office or non-executive office, consultants or former consultants or the personal service company of any such person) or their spouses or relatives, in each case the Issuer or any of its Subsidiaries or any associated company or to a trustee or nominees to be held for the benefit of any such person, in any such case pursuant to an employee, director or executive share or option or incentive scheme whether for all employees, directors, or executives or any one or more of them (a "Permitted Issue"), unless, in any such case, the same constitutes a Cash or Stock Dividend or otherwise gives (or, in the case of an issue or payment of up of Securities in connection with a Change of Control, will give) rise (or would, but for the provisions of these Conditions relating to roundings, minimum adjustments or the carry forward of adjustments, give rise) to an adjustment to the Conversion Price or is (or. in the case of any issue or payment up of Securities in connection with a Change of Control, will be) otherwise taken into account for the purposes of determining whether such an adjustment should be made. (c) Covenant not to Modify the Rights of Shares: The Issuer will not modify the rights attaching to the Shares with respect to voting, dividends or liquidation nor issue any other class of equity share capital carrying any rights which are more favourable than the rights attaching to the Shares, hut nothing in this Section 7(c) shall prevent: (i) the issue of any equity share capital to employees (including directors holding or formerly holding executive or non-executive office or the personal service company of any such person) whether of the Issuer or any 51 of the Subsidiaries or associated companies by virtue of their office or employment or any consultant or former consultant of or expert or former expert of the Issuer or any of the Subsidiaries or associated companies pursuant to any scheme or plan approved by the Issuer or which is established pursuant to such a scheme or plan which is or has been so approved; or (ii) any consolidation, reclassification, redesignation or subdivision of the Shares or the conversion of a Share into stock or vice versa; or (iii) any modification of such rights which is not, in the opinion of an Independent Adviser acting in good faith, materially prejudicial to the interests of the holders of the Bonds upon which opinion the Trustee shall be entitled to rely absolutely without liability to any person; or (iv) any issue of equity share capital where the issue of such equity share capital results, or would, but for the provisions of these Conditions relating to roundings and minimum adjustments or the carry forward of adjustments or, where comprising Shares, the tact that the consideration per Share receivable therefor is at least 95 per cent. of the Current Market Price per Share, otherwise result, in an adjustment to the Conversion Price; or (v) any issue of equity share capital or modification of rights attaching to the Shares, where prior thereto the Issuer shall have instructed an Independent Adviser to determine in good faith what (if any) adjustments should be made to the Conversion Price as being fair and reasonable to take account thereof and such Independent Adviser shall have determined in good faith either that no adjustment is required or that an adjustment resulting in a decrease in the Conversion Price is required and, if so, the new Conversion Price as a result thereof and the basis upon which such adjustment is to be made and, in any such case, the date on which the adjustment shall take effect (and so that the adjustment shall be made and shall take effect accordingly); or (vi) the amendment of the articles of association of the Issuer following a Change of Control to ensure that any Bondholder exercising its Conversion Right where the Conversion Date falls on or after the occurrence of a Change of Control will receive the same consideration in respect of any Shares required to be issued or transferred and delivered to it on exercise of Conversion Rights as it would have received in respect of such Shares had it exercised its Conversion Right at the time of the occurrence of the Change of Control and had such Shares been tendered in the relevant offer (a "Change of Control Conversion Right Amendment"). (d) Covenant not to Grant Other Securities Preferential Conversion, Exchange or Subscription Rights. The Issuer will, except as part of any employee, director or executive (including, for this purpose, consultants or experts) share or option or incentive scheme, procure that no Securities (whether issued by the Issuer or any Subsidiary or procured by the Issuer or any Subsidiary to be issued or issued by any other person pursuant to any arrangement with the Issuer or any Subsidiary) issued without rights to convert into, or exchange or subscribe for, Shares shall subsequently be granted such rights exercisable at a consideration per Share 52 which is less than 95 per cent. of the Current Market Price per Share on the date of the first public announcement of the proposed inclusion of such rights unless the same gives rise (or would, but for the provisions of these Conditions relating to roundings and minimum adjustments or the carry forward of adjustments, give rise) to an adjustment to the Conversion Price and that at no time shall there be in issue Shares of differing nominal values, save where such Shares have the same economic rights. (e) Covenant not to Prevent the Issue of Shares as Fully Paid: The Issuer will not make any issue, grant or distribution or take or omit to take any other action if the effect thereof would be that, on the exercise of Conversion Rights, Shares could not, under any applicable law then in effect, be legally issued as fully paid; (f) Covenant not to Reduce Issued Share Capital or Share Premium Account: The Issuer will not reduce its issued share capital, share premium account, or any uncalled liability in respect thereof, or any non-distributable reserves, except: (i) pursuant to the terms of issue of the relevant share capital; or (ii) by means of a purchase or redemption of share capital of the Issuer, in each case, to the extent permitted by applicable law; or (iii) where the reduction does not involve any distribution of assets to Shareholders; or (iv) solely in relation to a change in the currency in which the nominal value of the Shares is expressed; or (v) to create distributable reserves (to which, in respect of any such creation of distributable reserves by the Issuer in respect of which consent is required, the Trustee will be deemed to have irrevocably given its consent (without being required to take any action or any liability in respect thereof) prior to such creation of distributable reserves occurring and, to the extent that express consent is required, the Bondholders authorise and direct the Trustee to give its consent (without any liability for so doing) to such creation of distributable reserves); or (vi) by way of transfer to reserves as permitted under applicable law; or (vii) where the reduction is permitted by applicable law and the Trustee is advised in writing by an Independent Adviser (and the Trustee shall be entitled to rely on such advice without liability to any person), acting as an expert and in good faith, that the interests of the Bondholders will not be materially prejudiced by such reduction; or (viii) where the reduction is permitted by applicable law and results (or, in the case of a reduction in connection with a Change of Control, will result) in (or would, but for the provisions of these Conditions relating to roundings or the carry forward of adjustments, result in) an adjustment to the Conversion Price or is (or, in the case of a reduction in connection with a Change of Control, will be) otherwise taken into account for the purposes of determining whether such an adjustment should be made, 53 provided that, without prejudice to the other provisions of these Conditions, the Issuer may exercise such rights as it may from time to time be entitled pursuant to applicable law to purchase, redeem or buy back its Shares and any depositary or other receipts or certificates representing Shares without the consent of Bondholders. (g) Covenant to Give Notice to the Trustee and the Bondholders in the Event of an Offer for Shares: The Issuer will, if any offer is made to all (or as nearly as may be practicable all) Shareholders (or all (or as nearly as may be practicable all) Shareholders other than the offeror and/or any associates of the offeror) to acquire the whole or any part of the issued Shares, or if any person proposes a scheme with regard to such acquisition, give notice in writing of such offer or scheme to the Trustee and the Bondholders at the same time as any notice thereof is sent to the Shareholders (or as soon as practicable thereafter) that details concerning such offer or scheme may be obtained from the issuer on its website and, where such an offer or scheme has been recommended by the board of management of the Issuer, or where such an offer has become or been declared unconditional in all respects or such scheme has become effective, use reasonable endeavours to procure that a like offer or scheme is extended to the holders of any Shares issued during the period of the offer or scheme arising out of the exercise of Conversion Rights pursuant to these Conditions and/or to the holders of the Bonds (which like offer or scheme in respect of such Bondholders shall entitle any such Bondholders to receive the same type and amount of consideration it would have received had it held the number of Shares to which such Bondholder would be entitled assuming it were to exercise its Conversion Rights in the relevant Change of Control Period). (h) Reservation of Share Capital: The Issuer undertakes that it will, at all times, maintain treasury shares or authorised share capital, free of pre-emption rights sufficient in aggregate for the issuance of Shares that would be required to be delivered to Bondholders on exercise of Conversion Rights in respect of all outstanding Bonds from time to time. Furthermore, the issuer undertakes that it will propose to its 2020 general meeting and any subsequent general meeting thereafter, as applicable, the required resolution(s) to allow the Issuer sufficient authority from the general meeting to grant rights to subscribe for Shares and to exclude shareholders' pre-emption rights, to enable it to issue or deliver the Shares that it would be required to be issued or delivered to Bondholders on exercise of Conversion Rights in respect of all outstanding Bonds from time to time. (i) Listing of Shares: The Issuer undertakes to use reasonable endeavours to ensure that the Shares issued upon exercise of the Conversion Rights will be admitted to the Relevant Exchange (but this undertaking shall not be considered as being breached as a result of a Change of Control (whether or not recommended or approved by the board of management and supervisory board of the Issuer) that causes or gives rise to, whether following the operation of any applicable compulsory acquisition provision or otherwise, (including at the request of the person or persons controlling the Issuer as a result of the Change of Control) a de- listing of the Shares). (j) Listing of Bonds: The Issuer undertakes to make or cause to be made an application for the Bonds to be admitted to trading on the Open Market (Freiverkehr) of the Frankfurt Stock Exchange (or another internationally
54 recognised, regularly operating, regulated or non-regulated stock exchange or securities market) (the "Admission") within 30 calendar days following the Closing Date and to use reasonable endeavours to maintain such Admission to trading for so long as any of the Bonds remain outstanding, save that if the Issuer is unable to maintain such Admission as aforesaid. the Issuer undertakes to use reasonable endeavours to obtain and maintain a listing and/or admission to trading for the Bonds on such other stock exchange as the Issuer may from time to time determine and the Issuer will promptly give notice to the Bondholders and the Trustee of any such listing or delisting of the Bonds by any of such stock exchanges. (k) Terms and Conditions: The Issuer undertakes that by no later than the Closing Date it will (i) publish a copy of these Conditions (including a legend regarding the intended target market for the Bonds) on its website and (ii) thereafter (and for so long as any of the Bonds remain outstanding) maintain the availability of these Conditions (as the same may be amended in accordance with their terms) on such website. (l) Independent Adviser: The Issuer undertakes, whenever a function expressed in these Conditions to be performed by an Independent Adviser falls to be performed, to appoint and (for so long as such function is required to be performed) maintain an Independent Adviser. The Issuer has undertaken in the Trust Deed to deliver to the Trustee annually and otherwise on request by the Trustee a certificate of two directors of the Issuer, as to there not having occurred an Event of Default since the date of the last such certificate or if such event has occurred as to the details of such event. The Trustee will be entitled to rely on such certificate and shall not be obliged to independently monitor compliance by the Issuer with the undertakings set forth in these Conditions nor he liable to any person for not so doing. 8 Events of Default If any of the following events (each an "Event of Default") occurs and is continuing, the Trustee at its discretion may, and if so requested by the holders of at least one-quarter in principal amount of the Bonds then outstanding or if so directed by an Extraordinary Resolution and provided in each case that it is indemnified and/or secured and/or prefunded to its satisfaction shall, give notice to the Issuer that the Bonds are, and they shall accordingly immediately become, due and repayable at (i) in the case of the occurrence and continuation of an Event of Default pursuant to paragraph (b) below, an amount equal to the higher of (A) the Parity Value of the Bonds subject of the relevant exercise of Conversion Rights had the date of the declaration of the relevant Event of Default been the Delivery Date and (B) the Redemption Price for the Bonds or (ii) in the case of any other Event of Default, the Redemption Price for the Bonds together, in each case, with accrued interest (if any) to the date of payment: (a) Payment Default: the Issuer fails to pay the principal of or interest on or any other amount in respect of any Bonds when the same becomes due and payable and such failure continues for a period of 10 calendar days; or 55 (b) Conversion: the Issuer fails to deliver Shares upon exercise of Conversion Rights when the same is required to be delivered or otherwise a failure to duly and punctually comply with any of the Issuer's obligations in respect of the exercise of Conversion Rights and such default continues for a period of seven calendar days; or (c) Breach of Agreement: a default in the observance or performance of any other covenant or agreement contained in these Conditions or the Trust Deed which default is incapable of remedy or, if in the opinion of the Trustee is capable of remedy, is not in the opinion of the Trustee remedied within 30 calendar days after notice of such default shall have been given to the Issuer by the Trustee; or (d) Cross-Default: (i) any other present or future indebtedness of the Issuer or any of its Subsidiaries for or in respect of moneys borrowed or raised becomes (or becomes capable of being declared) due and payable prior to its stated maturity by reason of any actual or potential default, event of default or the like (howsoever described), or (ii) any such indebtedness is not paid when due or, as the case may be, within any originally applicable grace period, or (iii) the Issuer or any of its Subsidiaries fails to pay when due any amount payable by it under any present or future guarantee for, or indemnity in respect of, any moneys borrowed or raised provided that the aggregate amount of the relevant indebtedness, guarantees and indemnities in respect of which one or more of the events mentioned above in this Section 8(d) have occurred equals or exceeds €10,000,000 or its equivalent (on the basis of the middle spot rate for the relevant currency against the euro quoted by any leading bank on the day on which this paragraph operates); or (e) Bankruptcy: the Issuer or any Material Subsidiary of the Issuer (i) commences a voluntary case or proceeding under any Bankruptcy Law with respect to itself, (ii) consents to the entry of a judgment, decree or order for relief against it in an involuntary case or proceeding under any Bankruptcy Law, (iii) consents to the appointment of a Custodian of it or for substantially all of its property, (iv) consents to or acquiesces in the institution of a bankruptcy or an insolvency proceeding against it, (v) makes a general assignment for the benefit of its creditors, (vi) takes any corporate action to authorise or effect any of the foregoing, (vi) is unable to pay its debts, stops, suspends or threatens to stop or suspend all or a material part of (or a particular type of) its debts or (vii) proposes or makes a general assignment or an arrangement or composition with or for the benefit of the relevant creditors in respect of any of such debts or a moratorium is agreed or declared in respect of or affecting all or any part of (or of a particular type of) such debts; or (f) Winding Up: a court of competent jurisdiction enters a judgment, decree or order for relief in respect of the Issuer or any Material Subsidiary of the Issuer in an involuntary case or proceeding under any Bankruptcy Law, which shall (i) approve as properly filed a petition seeking reorganisation, arrangement, adjustment or composition in respect of the Issuer or any Material Subsidiary of the Issuer, (ii) appoint a Custodian of the Issuer or any Material Subsidiary of the Issuer or for substantially all of any of its property or (iii) order the winding-up or liquidation of its affairs; and such judgment, decree or order shall remain unstayed and in effect for a period of 90 consecutive days; or 56 (g) Judgments: one or more judgments in an aggregate amount in excess of €10,000,000 (or the equivalent thereof in any other currency or currencies) shall have been rendered against the Issuer or any Subsidiary of the Issuer and such judgments remain undischarged, unpaid or unstayed for a period of 60 days after such judgment or judgments become final and no longer subject to appeal, cassatie, or similar proceedings; or (h) Analogous Proceedings: there occurs, in relation to any Material Subsidiary of the Issuer, in any jurisdiction to which it or any of its assets are subject, any event which reasonably corresponds with any of those mentioned in Section 8(e) to 8(g) above; (i) Illegality: it is or will become unlawful for the Issuer to perform or comply with any one or more of its obligations under any of the Bonds or the Trust Deed; or (j) Cessation of Business: save in the case of a Material Subsidiary where such Material Subsidiary transfers all or substantially all of its business to the Issuer, another Material Subsidiary or another subsidiary which will immediately thereafter become a Material Subsidiary, the Issuer or any Material Subsidiary of the Issuer ceases (or threatens to cease) to carry on all or substantially all of its business. 9 Meetings of Bondholders, Modification and Waiver 9.1 Meetings of Bondholders The Trust Deed contains provisions for convening meetings of Bondholders to consider matters affecting their interests, including the sanctioning by Extraordinary Resolution of a modification of any of these Conditions or any provisions of the Trust Deed. Such a meeting may be convened by the Issuer or the Trustee and shall be convened by the Issuer if requested in writing by Bondholders holding not less than 10 per cent. in principal amount of the Bonds for the time being outstanding. The quorum for any meeting convened to consider an Extraordinary Resolution will be one or more persons holding or representing more than one-half in principal amount of the Bonds for the time being outstanding, or at any adjourned meeting one or more persons being or representing Bondholders whatever the principal amount of the Bonds so held or represented, unless the business of such meeting includes consideration of proposals, inter alia, (i) to change the Maturity Date or the dates on which interest is payable in respect of the Bonds, (ii) to modify the circumstances in which the Issuer or Bondholders are entitled to redeem the Bonds pursuant to Section 4.1. 4.2 or 4.3 (other than removing the right of the Issuer to redeem the Bonds pursuant to Section 4.1 or 4.2), (iii) to reduce or cancel the principal amount of, or interest on, the Bonds or to reduce the amount payable on redemption of the Bonds, (iv) to modify the basis for calculating the interest payable in respect of the Bonds, (v) to modify the provisions relating to, or cancel, Conversion Rights or the rights of Bondholders to receive Shares on exercise of Conversion Rights pursuant to these Conditions (other than a reduction to the Conversion Price), (vi) to increase the Conversion Price (other than in accordance with these Conditions), (vii) to change the currency of the denomination of the Bonds or of any payment in respect of the Bonds, (viii) to change the governing law of the Bonds, the Trust Deed or the Agency Agreement, or (ix) to modify the provisions concerning the quorum required at any meeting of Bondholders or the majority required to pass an Extraordinary 57 Resolution, in which case the necessary quorum will be one or more persons holding or representing not less than two- thirds, or at any adjourned meeting not less than one-third, in principal amount of the Bonds for the time being outstanding. Any Extraordinary Resolution duly passed by the Bondholders shall be binding on all Bondholders (whether or not they were present at any meeting at which such resolution was passed and whether or not they voted on such resolution). The Trust Deed provides that (i) a resolution in writing signed by or on behalf of the holders of not less than 75 per cent. of the aggregate principal amount of the Bonds outstanding (which may be contained in one document or several documents in the same form, each signed by or on behalf of one or more Bondholders) or (ii) a consent given by way of electronic consent through the relevant clearing system(s) (in a form satisfactory to the Trustee) by or on behalf of the holders of not less than 75 per cent. of the aggregate principal amount of the Bonds outstanding, shall, in any such case, be effective as an Extraordinary Resolution passed at a meeting of Bondholders duly convened and held. 9.2 Modification and Waiver The Trustee may agree, without the consent of the Bondholders, to (i) any modification of any of the provisions of the Trust Deed, any trust deed supplemental to the Trust Deed, the Agency Agreement, any agreement supplemental to the Agency Agreement, the Bonds or these Conditions which in the Trustee's opinion is of a formal, minor or technical nature or is made to correct a manifest error or to comply with mandatory provisions of law, and (ii) any other modification to the Trust Deed, any trust deed supplemental to the Trust Deed, the Agency Agreement, any agreement supplemental to the Agency Agreement. the Bonds or these Conditions (except as mentioned in the Trust Deed), and any waiver or authorisation of any breach or proposed breach, of any of the provisions of the Trust Deed, any trust deed supplemental to the Trust Deed, the Agency Agreement, any agreement supplemental to the Agency Agreement, the Bonds or these Conditions which is, in the opinion of the Trustee, not materially prejudicial to the interests of Bondholders. The Trustee may, without the consent of the Bondholders, determine that any Event of Default should not be treated as such, provided that in the opinion of the Trustee, the interests of Bondholders will not be materially prejudiced thereby. Any such modification, authorisation, waiver or determination shall be binding on the Bondholders and, if the Trustee so requires, shall be notified to the Bondholders promptly in accordance with Section 15.7. 9.3 Entitlement of the Trustee In connection with the exercise of its functions (including but not limited to those referred to in this Section 9) the Trustee shall have regard to the interests of Bondholders as a class but shall not have regard to any interests arising from circumstances particular to individual Bondholders (whatever their number) and, in particular but without limitation, shall not have regard to the consequences of the exercise of its trusts, powers or discretions for individual Bondholders resulting from their being for any purpose domiciled or resident in, or otherwise connected with, or subject to the jurisdiction of, any particular territory, and the Trustee shall not be entitled to require, nor shall any Bondholder be entitled to claim, from the Issuer, the Trustee or any other Person any indemnification or payment in respect of any tax consequence of any such exercise upon individual Bondholders, except to the extent provided for in these Conditions or the Trust Deed.
58 10 Enforcement The Trustee may at any time, at its discretion and without notice, take such proceedings, actions or steps (including lodging an appeal in any proceedings) against the issuer as it may think fit to enforce the provisions of the Trust Deed and the Bonds, but it shall not be bound to take any such proceedings, actions or steps unless (i) it shall have been so directed by an Extraordinary Resolution of the Bondholders or so requested in writing by the holders of at least one-quarter in principal amount of the Bonds then outstanding, and (ii) it shall have been indemnified and/or secured and/or prefunded to its satisfaction. Notwithstanding the above: (a) the Trustee may refrain from taking any proceedings, actions or steps in any jurisdiction if the taking of such action in that jurisdiction would, in its opinion, be contrary to any law of a relevant jurisdiction; and (b) the Trustee may refrain from taking any proceedings, actions or steps in any jurisdiction if in its opinion it would or may render it liable to any person or, it would or may not have the power to do the relevant thing in a relevant jurisdiction by virtue of any applicable law in that jurisdiction or if it is determined by any court or other competent authority in a relevant jurisdiction that it does not have such power. No Bondholder shall be entitled to (i) take any proceedings, actions or steps against the Issuer to enforce the performance of any of the provisions of the Trust Deed or the Bonds or (ii) take any other proceedings, actions or steps (including lodging an appeal in any proceedings) in respect of or concerning the Issuer, in each case unless the Trustee, having become bound so to take any such proceedings, actions or steps, fails so to do within a reasonable period and such failure is continuing. 11 The Trustee The Trust Deed contains provisions for the indemnification of the Trustee and for its relief from responsibility, including: (a) provisions relieving it from taking any proceedings, actions or steps unless indemnified and/or secured and/or prefunded to its satisfaction; and (b) provisions limiting or excluding its liability in certain circumstances. The Trustee is entitled to enter into business transactions with the Issuer and any entity related to the issuer without accounting for any profit. The Trust Deed provides that, when determining whether an indemnity or any security or pre-funding is satisfactory to it, the Trustee shall be entitled (i) to evaluate its risk in any given circumstance by considering the worst-case scenario and (ii) to require that any indemnity or security or prefunding given to it by the Bondholders or any of them be given on a joint and several basis and be supported by evidence satisfactory to it as to the financial standing and creditworthiness of each counterparty and/or as to the value of the security and an opinion as to the capacity, power and authority of each counterparty and/or the validity and effectiveness of the security. 59 The Trustee may act and rely without liability to Bondholders and without further investigation on a report, confirmation, certificate, opinion or any advice of any accountants, financial advisers, financial institution, an Independent Adviser or other expert, whether or not addressed to it and whether their liability in relation thereto is limited (by its terms or by any engagement letter relating thereto entered into by the Trustee or any other person or in any other manner) by reference to a monetary cap, methodology or otherwise. The Trustee may accept and shall be entitled to act and rely on any such report, confirmation, certificate, opinion or advice and such report, confirmation, certificate, opinion or advice shall be binding on the issuer, the Trustee and the Bondholders. 12 Agents 12.1 Agent of the Issuer The Agents and the Calculation Agent, when acting in that capacity, act solely as agents of the Issuer and do not assume any obligation towards or relationship of agency or trust for or with any Bondholder or any Person holding an interest in respect of any Bond through an account with a financial intermediary or otherwise. 12.2 Appointment and Termination of Agents and the Calculation Agent The Issuer has initially appointed the Principal Paying, Transfer and Conversion Agent, the Registrar, the Conversion Agents and the Calculation Agent for the Bonds as stated above. The Issuer may at any time, with the approval of the Trustee, appoint additional or other Agents or Calculation Agents and terminate the appointment of such Agents or Calculation Agent. Notice of any such termination or appointment and of any change in the office through which any Agent will act will be promptly given to each Bondholder in the manner described in Section 15.7 hereof. 12.3 Duty to Maintain Office As long as the Bonds, including in the event that some but not all Bonds originally issued, are outstanding, the Issuer shall maintain a Principal Paying, Transfer and Conversion Agent and a Calculation Agent which shall each be a financial institution of international repute or a financial adviser with appropriate expertise. 13 Registration and Transfer of Bonds 13.1 Registration The Issuer will cause a register (the "Register") to be kept at the specified office of the Registrar outside the United Kingdom on which will he entered the names and addresses of the holders of the Bonds and the particulars of the Bonds held by them and of all transfers, redemptions and conversions of Bonds. 13.2 Transfer Bonds may, subject to the terms of the Agency Agreement and to Sections 13.3 and 13.4, be transferred by lodging the relevant Bond (with the form of application for transfer in respect thereof duly executed and duly stamped where applicable) at the specified office of the Registrar or any Paying, Transfer and Conversion Agent or Conversion Agent. 60 No transfer of a Bond will be valid unless and until entered on the Register. A Bond may be registered only in the name of, and transferred only to, a named person (or persons, not exceeding four in number). The Registrar will within seven business days, in the place of the specified office of the Registrar, of any duly made application for the transfer of a Bond, register the relevant transfer and deliver a new Bond to the transferee at the specified office of the Registrar or (at the risk and, if mailed at the request of the transferee or, as the case may be, the transferor otherwise than by ordinary mail, at the expense of the transferee or, as the case may be, the transferor) mail the Bond by uninsured mail to such address as the transferee or, as the case may be, the transferor may request. 13.3 Formalities Free of Charge Such transfer NA will be effected without charge subject to (i) the person making such application for transfer paying or procuring the payment of any taxes, duties and other governmental charges in connection therewith, (ii) the Registrar being satisfied with the documents of title and/or identity of the person making the application and (iii) such reasonable regulations as the issuer may from time to time agree with the Registrar and the Trustee (and as initially set out in the Agency Agreement). 13.4 Closed Periods Neither the Issuer nor the Registrar will be required to register the transfer of any Bond (or part thereof) (i) during the period of 15 days ending on and including the day immediately prior to the Maturity Date or any earlier date fixed for redemption of the Bonds pursuant to Section 4.1 or 4.2; (ii) in respect of which a Conversion Notice has been delivered in accordance with Section 5.2; (iii) in respect of which a Bondholder has exercised its right to require redemption pursuant to Section 4.3; or (iv) during the period of 15 days ending on (and including) ally Record Date in respect of any payment of interest on the Bonds. 14 Definitions As used herein, the following capitalised terms have the meanings set forth below: "Additional Amounts" has the meaning set forth in Section 6. "Additional Shares" has the meaning set forth in Section 5.4(f). "Agency Agreement" has the meaning set forth in Section 1.1. "Agents" has the meaning set forth in Section 1.1. "Bankruptcy Law" means Title 11, U.S. Code or any similar federal, state or foreign law for the relief of debtors and shall for the avoidance of doubt include the Dutch Bankruptcy Act (Faillissementswet) and/or any other proceedings listed in annex A or annex B to Council Regulation EC No. 136/2000 of 29 May 2000 on insolvency Proceedings. "Bondholder" means any Person who is registered as the owner of such Bonds on the Register. 61 "Bonds" has the meaning set forth in Section 1.1. "Business Day" means a calendar day other than a Saturday or a Sunday which in Amsterdam is neither a public holiday nor a calendar day on which banking institutions are closed and, in the case of payments in euro, on which the TARGET System is open. "Calculation Agent" has the meaning set forth in Section 1.1. "Capital Markets Indebtedness" has the meaning set forth in Section 2.2. "cash" includes any promise or undertaking to pay cash or any release or extinguishment of, or set-off against, a liability to pay a cash amount. "Cash or Stock Dividend" means (i) any dividend or distribution paid or payable solely in cash on a Share. and (ii) any dividend or distribution which shall be treated to be paid or payable in cash on a Share pursuant to the following provisions: (a) (i) where a dividend or distribution in cash is announced which is to be, or may at the election of a holder or holders of a Share be, satisfied by the issue or delivery of Shares or other property or assets; or (ii) where a capitalisation of profits or reserves is announced which is to be, or may at the election of a holder or holders of a Share be. satisfied by the payment of cash, then the dividend, distribution or capitalisation in question shall be treated as a dividend or distribution in cash of an amount equal to the greater of: (x) the Fair Market Value of such cash amount as at the Ex-Date in respect of such dividend or distribution; and (y) the Current Market Price of such Shares, or, as the case may be, the Fair Market Value of such other property or assets, as at the Ex-Date in respect of such dividend or distribution or capitalisation or, in any such case, if later, the date on which the number of Shares (or amount of such other property or assets, as the case may be) which may be issued or delivered is determined; or (z) where there shall be (other than in the circumstances the subject of paragraph (a) above) any issue of Shares or other property or assets by way of capitalisation of profits or reserves where such issue is expressed to be, or in lieu of, a dividend or distribution in cash (whether or not a cash dividend or distribution equivalent or amount is announced or would otherwise be payable to holders of the Shares, whether at their election or otherwise), then the issue in question shall be treated as a dividend or distribution in cash of an amount equal to the Current Market Price of such Shares or, as the case may be, the Fair Market Value of such other property or assets, as at the Ex-Date in respect of such dividend or entitlement in relation to such issue or, if later, the date on which the number of Shares (or amount of such other property or assets, as the case may be) to be issued is determined.
62 A "Change of Control" shall occur if a person or persons acting together acquires or acquire directly or indirectly (i) more than 50 per cent. of Voting Rights of the Issuer or (ii) the right to appoint and/or remove all or a majority of the members of the board of management (raad van bestuur) or supervisory board (raad ran commissarissen) of the Issuer. "Change of Control Conversion Price" has the meaning set forth in Section 5.4(c). "Change of Control Conversion Right Amendment" has the meaning set forth in Section 7(c). "Closing Date" means 21 January 2020. "Closing Price" means, in respect of a Share, Security, Reclassified Security or, as the case may be, a Spin- off Security, option, warrant or other right or asset, on any dealing day in respect thereof, the closing price on the Relevant Exchange on such dealing day of a Share, Security, Reclassified Security, or, as the case may be, a Spin-off Security, option, warrant or other right or asset published by or derived from Bloomberg page HP (or any successor ticker page) (setting "Last Price", or any other successor setting and using values not adjusted for any event occurring after such dealing day; and for the avoidance of doubt, all values will be determined with all adjustment settings on the DPDF Page, or any successor or similar setting, switched off) in respect of such Share, Security, Reclassified Security, Spin-off Security, options, warrants or other rights or assets (all as determined by the Calculation Agent) (and for the avoidance of doubt such Bloomberg page for the Shares as at the Closing Date is PHARM NA Equity HP) if available, or, in any other case, such other pricing source (if any) as shall be determined to be appropriate by an Independent Adviser on such dealing day. provided that: (i) if on any such dealing day (for the purpose of this definition, the "Original Date") such price is not available or cannot otherwise be determined as provided above, the Closing Price of a Share, Security, Reclassified Security, a Spin-off Security, option, warrant or other right or asset, as the case may be, in respect of such dealing day shall be the Closing Price, determined by the Calculation Agent as provided above, on the immediately preceding such dealing day on which the same can be so determined, provided however that if such immediately preceding dealing day falls prior to the fifth day before the Original Date, the Closing Price in respect of such dealing day shall be considered to be not capable of being determined pursuant to this proviso (i); and (ii) if the Closing Price cannot be determined as aforesaid, the Closing Price of a Share, Security, option, warrant, or other right or asset, as the case may be, shall be determined as at the Original Date by an Independent Adviser in such manner as it shall determine in good faith to be appropriate, and the Closing Price determined as aforesaid on or as at any dealing day shall, if not in the Relevant Currency, be translated into the Relevant Currency at the Prevailing Rate on such dealing day. "Code" has the meaning set forth in Section 3.5. 63 "Combined Consideration" means New Securities in combination with Other Consideration. "Conditions" has the meaning set forth in Section 1.2. "Conversion Agent" has the meaning set forth in Section 1.1. "Conversion Date" has the meaning set forth in Section 5.2. "Conversion Notice" has the meaning set forth in Section 5.2. "Conversion Period" has the meaning set forth in Section 5.1. "Conversion Price" has the meaning set forth in Section 5.1. "Conversion Rights" has the meaning set forth in Section 5.1. "Current Market Price" means, in respect of a Share at a particular date, the arithmetic average of the daily Volume Weighted Average Price of a Share on each of the five consecutive dealing days ending on the dealing day immediately preceding such date, as determined by the Calculation Agent, provided that: (a) for the purposes of determining the Current Market Price pursuant to Section 5.4(a)(ii) or (iii) (and pursuant to Formulas 2 and 3 when used in the application thereof) in circumstances where the relevant event relates to an issue of Shares, if at any time during the said five dealing day period (which may be on each of such five dealing days) the Volume Weighted Average Price shall have been based on a price ex-dividend (or ex- any other entitlement) and/or during some other part of that period (which may be on each of such five dealing days) the Volume Weighted Average Price shall have been based on a price cum-dividend (or cum- any other entitlement), in any such case which has been declared or announced, then: (i) if the Shares to be so issued do not rank for the dividend (or entitlement) in question, the Volume Weighted Average Price on the dates on which the Shares shall have been based on a price cum-dividend (or cum- any other entitlement) shall for the purpose of this definition be deemed to be the amount thereof reduced by an amount equal to the Fair Market Value of any such dividend or entitlement per Share as at the Ex-Date in respect of such dividend or entitlement (or, where on each of the said five dealing days the Volume Weighted Average Price shall have been based on a price cum-dividend (or cum-any other entitlement), as at the date of first public announcement of such dividend or entitlement), in any such case, determined by the Calculation Agent on a gross basis and disregarding any withholding or deduction required to be made for or on account of tax, and disregarding any associated tax credit; or (ii) if the Shares to be so issued do rank for the dividend or entitlement in question, the Volume Weighted Average Price on the dates on which the Shares shall have been based on a price ex- dividend (or ex- any other entitlement) shall for the purpose of this definition be deemed to be the 64 amount thereof increased by an amount equal to the Fair Market Value of any such dividend or entitlement per Share as at the Ex-Date in respect of such dividend or entitlement, in any such case, determined by the Calculation Agent on a gross basis and disregarding any withholding or deduction required to be made for or on account of tax, and disregarding any associated tax credit; and (b) if any day during the said five dealing day period was the Ex-Date in respect of any dividend (or any other entitlement) the Volume Weighted Average Prices that shall have been based on a price cum- such dividend (or cum- such entitlement) shall for the purpose of this definition be deemed to be the amount thereof reduced by an amount equal to the Fair Market Value of any such dividend or entitlement per Share as at the Ex-Date in respect of such dividend or entitlement. "Custodian" means any receiver, trustee, assignee, liquidator. sequestrator or similar official under any Bankruptcy Law. "dealing day" means, in respect of the Shares or, as the case may be, Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets, any calendar day other than a Saturday or Sunday that is a day on which the Relevant Exchange in respect thereof is scheduled to be open for business and on which the Shares or, as the case may be, Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets, are scheduled to be capable of being dealt in (other than a day on which trading is scheduled to close prior to the regular weekday closing time) provided that, unless otherwise specified or the context otherwise requires, references to "dealing day" shall be a dealing day in respect of the Shares. A "Delisting Event" shall occur where the Shares cease to be listed, traded or publicly quoted on Euronext Amsterdam for any reason and are not immediately re-listed, re- traded or re-quoted on another internationally recognised, regularly operating and regulated stock exchange. "Delivery Date" has the meaning set forth in Section 5.3(c). "Dividend Determination Date" means the record date or other due date for establishment of entitlement in respect of the relevant Cash or Stock Dividend. "equity securities" means, in relation to any entity, its issued share capital, excluding any part of that capital which does not carry any right to participate beyond a specified amount in a distribution of dividends or assets. "euro" and "€" means the currency introduced at the start of the third stage of the European economic and monetary union pursuant to the Treaty establishing the European Community, as amended. "Euronext Amsterdam" means Euronext in Amsterdam, a regulated market of Euronext Amsterdam N.V. or any successor thereof. "Event of Default" has the meaning set forth in Section 8. 65 "Ex-Date" means, in respect of any Cash or Stock Dividend, other dividend, distribution, entitlement, capitalisation, resignation, reclassification, sub-division, consolidation, issue, offer, grant or other entitlement, the first date on which the Shares are traded ex- such relevant Cash or Stock Dividend, other dividend, distribution, entitlement, capitalisation, resignation, reclassification, sub-division, consolidation, issue, offer, grant or other entitlement on the Relevant Exchange (or, in the case of a dividend which is a purchase or redemption of Shares (or, as the case may be, any depositary or other receipts or certificates representing Shares), the date on which such purchase or redemption is made). "Expiration Time" has the meaning set forth in Section 5.4(h). "Extraordinary Resolution" has the meaning set forth in the Trust Deed. "Fair Market Value" means, on any date (the "FMV Date"): (a) in the case of a Cash or Stock Dividend, the amount of such Cash or Stock Dividend, as determined in good faith by the Calculation Agent; (b) in the case of any other cash amount, the amount of such cash, as determined in good faith by the Calculation Agent; (c) in the case of Securities (including Shares), Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets that are publicly traded on a Relevant Exchange of adequate liquidity (as determined in good faith by the Calculation Agent or an Independent Adviser), the arithmetic mean of: (i) in the case of Shares or (to the extent constituting equity securities) other Securities, Reclassified Securities or Spin-Off Securities, for which the daily Volume Weighted Average Price (disregarding for this purpose proviso (ii) to the definition thereof) can be determined, such daily Volume Weighted Average Price of the Shares or such other Securities, Reclassified Securities or Spin-Off Securities; and (ii) in any other case, the Closing Prices of such Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets, in the case of both (i) and (ii) during the period of five dealing days on the Relevant Exchange for such Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets commencing on such FMV Date (or, if later, the date (the "Adjusted FMV Date") which falls on the first such dealing day on which such Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets are publicly traded, provided that where such Adjusted FMV Date falls after the fifth day following the FMV Date, the Fair Market Value of such Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets shall instead be determined pursuant to paragraph (d) below, and no such Adjusted FMV Date shall be deemed to apply) or such shorter period as such Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets are publicly traded, all as determined in good faith by the Calculation Agent;
66 (d) in the case of Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets that are not publicly traded on a Relevant Exchange of adequate liquidity (as aforesaid) or where otherwise provided in paragraph (c) above to be determined pursuant to this paragraph (d), an amount equal to the fair market value of such Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets as determined in good faith by an Independent Adviser, on the basis of a commonly accepted market valuation method and taking account of such factors as it considers appropriate, including the market price per Share, the dividend yield of an Share, the volatility of such market price, prevailing interest rates and the terms of such Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets, and including as to the expiry date and exercise price or the like (if any) thereof. Such amounts shall (if not expressed in the Relevant Currency on the FMV Date (or, as the case may be, the Adjusted FMV Date)) be translated into the Relevant Currency at the Prevailing Rate on the FMV Date (or, as the case may be, the Adjusted FMV Date), all as determined in good faith by the Calculation Agent. In addition, in the case of (i) and (ii) above, the Fair Market Value shall be determined on a gross basis and disregarding any withholding or deduction required to be made for or on account of tax, and disregarding any associated tax credit. "FATCA" has the meaning set forth in Section 3.5. "FATCA Withholding" has the meaning set forth in Section 3.5. "Further Bonds" means any further Bonds issued pursuant to Section 15.6 and consolidated and forming a single series with the then outstanding Bonds. "indebtedness" shall be construed so as to include any obligation for the payment or repayment of money, whether present or future, actual or contingent. "Independent Adviser" means an independent institution with appropriate expertise, which may be the Calculation Agent, appointed by the Issuer at its own expense and (other than where the initial Calculation Agent is appointed) approved in writing by the Trustee or, if the Issuer fails to make such appointment and such failure continues for a reasonable period (as determined by the Trustee in its sole discretion) and the Trustee is indemnified and/or secured and/or prefunded to its satisfaction against the liabilities, costs, fees and expenses of such adviser and otherwise in connection with such appointment, appointed by the Trustee (without liability for so doing) following notification to the Issuer, which appointment shall be deemed to be made by the Issuer. "Interest Payment Date" has the meaning set forth in Section 3.2. "Interest Period" has the meaning set forth in Section 3.2. "Judgment Currency" has the meaning set forth in Section 15.4. a "Material Subsidiary" means any Subsidiary: 67 (i) whose (a) total assets or (b) total revenues or (c) operating result (consolidated in the case of a Subsidiary which itself has subsidiaries) represent five per cent. or more of the consolidated total assets of the issuer and its Subsidiaries or the consolidated total revenues of the Issuer and its Subsidiaries or the consolidated operating result of the Issuer and its Subsidiaries, as the case may be, in each case as calculated by reference to the then latest audited financial statements of such Subsidiary (consolidated or, as the case may be, unconsolidated) and the then latest audited consolidated financial statements of the Issuer provided that: (a) in the case of a Subsidiary acquired or an entity which becomes a Subsidiary after the end of the financial period to which the then latest audited consolidated financial statements of the Issuer relate, the reference to the then latest audited consolidated financial statements of the Issuer for the purposes of the calculation of the above shall until the consolidated audited financial statements of the Issuer are published for the financial period in which the acquisition is made or, as the case may be, in which such entity becomes a Subsidiary, be deemed to be a reference to the then latest consolidated financial statements of the Issuer adjusted in such manner as may be deemed appropriate by the Issuer to consolidate the latest audited financial statements (consolidated or, as the case may be, unconsolidated) of such Subsidiary in such financial statements; (b) if, in the case of any Subsidiary, no audited financial statements (consolidated or, as the case may be, unconsolidated) are prepared, then the determination of whether or not such Subsidiary is a Material Subsidiary shall be determined by reference to its unaudited annual financial statements (if any) or on the basis of pro forma financial statements (consolidated or, as the case may be, unconsolidated); and (c) if the latest financial statements of any Subsidiary are not prepared on the basis of the same accounting principles, policies and practices of the latest consolidated audited financial statements of the Issuer, then the determination of whether or not such Subsidiary is a Material Subsidiary shall be based on pro forma financial statements or, as the case may be, consolidated financial statements of such Subsidiary prepared on the same accounting principles, policies and practices as adopted in the latest consolidated audited financial statements of the Issuer, or an appropriate restatement or adjustment to the relevant financial statements of each Subsidiary; or (ii) to which is transferred all or substantially all of the business, undertaking and assets of a Subsidiary which immediately prior to such transfer is a Material Subsidiary, whereupon the transferor Subsidiary shall immediately cease to be a Material Subsidiary and the transferee Subsidiary shall immediately become a Material Subsidiary under the provisions of this sub-paragraph (ii) upon publication of its next audited financial statements but so that such transferor Subsidiary or such transferee Subsidiary may be a Material Subsidiary on or at any time after the date on which such audited financial statements have been published by virtue of the provisions of sub-paragraph (i) above or (as a result of another transfer to which this sub-paragraph (ii) applies) before, on or at any time after such date by virtue of the provisions of this sub-paragraph (ii). 68 "Maturity Date" has the meaning set forth in Section 1.1. "Merger Date" means, in respect of any Merger Event, the date on which all holders of the Shares (other than, in the case of a takeover offer, any Shares owned or controlled by the offeror) have agreed or irrevocably become obligated to transfer their Shares. "Merger Event" means any (i) consolidation, amalgamation or merger of the issuer with or into another entity (other than a consolidation, amalgamation or merger where the Issuer is the continuing entity) or (ii) a statutory split up (other than a Spin-off Event). "New Securities" means equity securities (whether of the Issuer or a third party) which are publicly traded on a Recognised Exchange. "Optional Redemption Date" has the meaning set forth in Section 4.1. "Optional Redemption Notice" has the meaning set forth in Section 4.1. "Other Consideration" means cash, securities (other than New Securities) or other property (whether of the Issuer or a third party). "Parity Value" means, in respect of any dealing day, the amount determined in good faith by the Calculation Agent and calculated as follows: PV = N x VWAP where: PV = the Parity Value. N = €100,000 by the Conversion Price in effect on such dealing day (which shall be the Change of Control Conversion Price if such Change of Control Conversion Price would apply in respect of any exercise of Conversion Rights in respect of which the Conversion Date would fall on such dealing day), provided that if (A) such dealing day falls on or after (i) the Ex-Date in respect of any entitlement in respect of which an adjustment is required to be made to the Conversion Price pursuant to Section 5.4(a)(i), 5.4(a)(ii), 5.4(a)(iv), 5.4(a)(v), 5.4(a)(vi), 5.4(a)(viii), 5.4(a)(ix) or 5.4(a)(x) or (ii) the relevant date of first public announcement (as applicable pursuant to Section 5.4(a)(iii), 5.4(a)(vii) or 5.4(a)(xi)) in respect of which an adjustment is required to be made to the Conversion Price pursuant to Section 5.4(a)(iii), 5.4(a)(vii) or 5.4(a)(xi), and (B) such adjustment is not yet in effect on such dealing day, the Conversion Price in effect on such dealing day shall for the purpose of this definition only be multiplied by the adjustment factor (as determined pursuant to the relevant formula in Section 5.4(b)) subsequently determined by the Calculation Agent to be applicable in respect of the relevant Conversion Price adjustment. VWAP = the Volume Weighted Average Price of a Share (translated if necessary into euro at the Prevailing Rate) on such dealing day. "Permitted Issue" has the meaning set forth in Section 7(b). 69 "Person" means an individual, a corporation, a limited liability company, a firm, a joint venture, an undertaking, a partnership, an association, a trust or any other entity or organisation, including a government or political subdivision or an agency or instrumentality thereof (in each case whether or not being a separate legal entity). "Prevailing Rate" means in respect of any pair of currencies on any date, the spot mid- rate of exchange between the relevant currencies prevailing as at or about 12 noon (Amsterdam time) on that date (tor the purpose of this definition, the "Original Date") as appearing on or derived from Bloomberg page BFIX (or any successor page) in respect of such pair of currencies, or, if such a rate cannot be so determined, the rate prevailing as at 12 noon (Amsterdam time) on the immediately preceding day on which such rate can be so determined, provided that if such immediately preceding day falls earlier than the fifth day prior to the Original Date or if such rate cannot be so determined (all as determined in good faith by the Calculation Agent), the Prevailing Rate in respect of the Original Date shall be the rate determined in such other manner as an Independent Adviser shall consider appropriate. "Principal Paying, Transfer and Conversion Agent" has the meaning set forth in Section 1.1. "Proceedings" has the meaning set forth in Section 15.8. "Purchased Shares" has the meaning set forth in Section 5.4(h). "Put Date"- has the meaning set forth in Section 4.3. "Put Event" means a Change of Control or a Delisting Event. "Put Exercise Notice" has the meaning set forth in Section 4.3. "Put Notice"-has the meaning set forth in Section 4.3. "Put Period" means the period commencing on the occurrence of a Put Event and ending 60 calendar days following the Put Event or, if later, 60 calendar days following the date on which a Put Notice is given to Bondholders as required by Section 4.3. "Reclassification" has the meaning set forth in Section 5.4(a)(x). "Reclassified Securities" has the meaning set forth in Section 5.4(a)(x). "Recognised Exchange" means a regulated and regularly operating stock exchange. "Record Date" has the meaning set forth in Section 3.2(d). "Redemption Notice" means an Optional Redemption Notice or a Tax Redemption Notice. "Redemption Price" has the meaning set forth in Section 3.1. "Reference Shares" means, in respect of the exercise of Conversion Rights by a Bondholder, the number of Shares (rounded down, if necessary, to the nearest whole number of Shares) determined in good faith by the Calculation Agent by dividing the
70 aggregate principal amount of the Bonds which are the subject of the relevant exercise of Conversion Rights by the Conversion Price in effect on the relevant Conversion Date, except that where the Conversion Date falls on or after the date an adjustment to the Conversion Price takes effect pursuant to Sections 5.4(a)(i), (ii), (iv), (v), (vi), (viii), (ix) or (x) in circumstances where the Delivery Date falls on or prior to the record date or other due date for establishment of entitlement in respect of the relevant event giving rise to such adjustment, then the Conversion Price in respect of such exercise shall be such Conversion Price as would have been applicable to such exercise had no such adjustment been made. "Register" has the meaning set forth in Section 13.1. "Relevant Currency" means, at any time, the currency in which the Shares are quoted or dealt in at such time on the Relevant Exchange. "Relevant Date" means, in respect of any Bond, whichever is the later of: (i) the date on which payment in respect of it first becomes due; and (ii) if any amount payable is improperly withheld or refused, the earlier of (a) the date on which payment in full of the amount outstanding is made and (b) the date falling seven days after the date on which the Trustee or the Principal Paying, Transfer and Conversion Agent has given notice to Bondholders of receipt of all sums due in respect to all the Bonds up to that seventh day (except that there is failure in the subsequent payment to the relevant holders) as provided in these Conditions. "Relevant Exchange" means: (i) in respect of the Shares, Euronext Amsterdam or, if at the relevant time the Shares are not at that time listed and admitted to trading on Furonext Amsterdam, the principal stock exchange or securities market on which the Shares are then listed, admitted to trading or quoted or dealt in, and (ii) in respect of any Securities (other than Shares), Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets, the principal stock exchange or securities market on which such Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets are then listed, admitted to trading or quoted or dealt in, where "principal stock exchange or securities market" shall mean the stock exchange or securities market on which such Shares, Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets are listed, admitted to trading or quoted or dealt in, provided that if such Shares, Securities, Reclassified Securities, Spin- Off Securities, options, warrants or other rights or assets are listed, admitted to trading or quoted or dealt in (as the case may be) on more than one stock exchange or securities market at the relevant time, then "principal stock exchange or securities market" shall mean that stock exchange or securities market on which such Shares, Securities, Reclassified Securities, Spin-Off Securities, options, warrants or other rights or assets are then traded as determined by the Calculation Agent (if the Calculation Agent determines that it is able to make such determination) or (in any other case) by an Independent Adviser by reference to the stock exchange or securities market with the highest average 71 daily trading volume in respect of such Shares, Securities, Reclassified Securities, Spin- Off Securities, options, warrants or other rights or assets. A "Retroactive Adjustment" shall occur if (i) the Delivery Date in relation to the conversion of any Bond shall be after the date which is the record date in respect of any sub-division or consolidation, as is mentioned in Section 5.4(a)(i), or which is the record date or other due date for the establishment of entitlement for any such issue, distribution, grant or offer (as the case may be) as is mentioned in Section 5.4(a)(ii), 5.4(a)(iv), 5.4(a)(v), 5.4(a)(vi), 5.4(a)(viii), 5.4(a)(ix) or 5.4(a)(x), or which is the date of the first public announcement of the terms of any such issue or grant as is mentioned in Section 5.4(a)(iii) and 5.4(a)(vii) and (ii) the Conversion Date falls before the relevant adjustment to the Conversion Price becomes effective under Section 5.4(a). "Securities" means any securities including, without limitation, Shares and any other shares in the capital of the Issuer, and options, warrants or other rights to subscribe for or purchase or acquire Shares or any other shares in the capital of the issuer. "Settlement Disruption Event" means an event beyond the control of the Issuer as a result of which any Euroclear Nederland or Clearstream Banking Netherlands or any of their respective successors or any other central securities depository cannot settle the book-entry transfer of the Shares on such date. "Shareholders" means the holders of Shares. "Shares" means the ordinary shares in the capital of the Issuer with, as at the Closing Date, a nominal value €0.01 each. "Short Period" has the meaning set forth in Section 3.2. "Spin-off Event" has the meaning set forth in Section 5.4(a)(x). "Spin-off Securities" has the meaning set forth in Section 5.4(a)(x). "Subsidiary" means a subsidiary (dochtermaatschappy) as defined in Section 2:24a of Book 2 of the Dutch Civil Code. "TARGET System" means the Trans-European Automated Real-Time Gross Settlement Express Transfer (TARGET2) System. "Tax Redemption Date has the meaning set forth in Section 4.2. "Tax Redemption Notice" has the meaning set forth in Section 4.2. "Taxing Jurisdiction" has the meaning set forth in Section 6. "Transfer Taxes" has the meaning set forth in Section 5.5. "Trustee" has the meaning set forth in Section 1.1. "Volume Weighted Average Price" means, in respect of a Share, Security, Reclassified Security or, as the case may he, a Spin-Off Security, on any dealing day in respect thereof, the volume weighted average price on such dealing day on the Relevant Exchange of a 72 Share, Security, Reclassified Security or, as the case may be, a Spin-Off Security, as published by or derived from Bloomberg page HP (or any successor page) (setting "Weighted Average Line", or any other successor setting and using values not adjusted for any event occurring after such dealing day; and for the avoidance of doubt, all values will be determined with all adjustment settings on the DPDF Page, or any successor or similar setting, switched off) in respect of such Share, Security, Reclassified Security or. as the case may be, Spin-Off Security and such Relevant Exchange (and for the avoidance of doubt such Bloomberg page for the Shares as at the Closing Date is PHARM NA Equity HP), if any or, in any such case, such other pricing source (if any) as shall be determined in good faith to be appropriate by an Independent Adviser on such dealing day, provided that: (i) if on any such dealing day (for the purposes of this definition, the "Original Date") such price is not available or cannot otherwise be determined as provided above, the Volume Weighted Average Price of a Share, Security, Reclassified Security or Spin-Off Security, as the case may be, in respect of such dealing day shall be the Volume Weighted Average Price, determined as provided above, on the immediately preceding such dealing day on which the same can be so determined. provided however that if such immediately preceding dealing day falls prior to the fifth day before the Original Date, the Volume Weighted Average Price in respect of such dealing day shall be considered to be not capable of being determined pursuant to this proviso (i); and (ii) if the Volume Weighted Average Price cannot be determined as aforesaid, the Volume Weighted Average Price of a Share, Security, Reclassified Security or Spin-Off Security, as the case may be, shall be determined as at the Original Date by an Independent Adviser in such manner as it shall determine in good faith to be appropriate, and the Volume Weighted Average Price determined as aforesaid on or as at any dealing day shall, if not in the Relevant Currency, be translated into the Relevant Currency at the Prevailing Rate on such dealing day. "Voting Rights" means in relation to any entity the right generally to vote at a general meeting of shareholders of such entity (irrespective of whether or not, at the time, stock of any other class or classes shall have, or might have, voting power by reason of the happening of any contingency) or to elect the majority of the members of the board of management or supervisory board of such entity. References to any issue or offer or grant to existing holders of Shares "as a class" shall be taken to be references to an issue or offer or grant to all or substantially all existing holders of Shares, other than those to whom, by reason of the laws of any territory or requirements of any recognised regulatory body or any other stock exchange or securities market in any territory or in connection with fractional entitlements, it is determined not to make such issue or offer or grant. In making any calculation or determination of Closing Price, Current Market Price or Volume Weighted Average Price, such adjustments (if any) shall be made and as the Calculation Agent or an Independent Adviser considers appropriate in good faith to reflect any consolidation or sub-division of the Shares or any issue of Shares by way of capitalisation of profits or reserves, or any like or similar event. 73 15 Miscellaneous 15.1 Authentication The Bonds evidenced by this certificate shall not become valid or obligatory until the certificate of authentication hereon shall have been duly signed by the Registrar acting under the Agency Agreement. 15.2 Repayment of Funds All monies paid by the Issuer to the Principal Paying, Transfer and Conversion Agent or Conversion Agent for payment of principal or interest on any Bond which remain unclaimed at the end of two years after such payment has been made will be repaid to the Issuer and all liability of such Agent with respect thereto will cease, and, to the extent permitted by law, the Bondholders shall thereafter look only to the issuer for payment as a general unsecured creditor thereof. 15.3 Prescription Claims against the Issuer for payment in respect of the Bonds shall be prescribed and become void unless made within 10 years (in the case of principal or any other amount (other than interest)) or five years (in the case of interest) from the appropriate Relevant Date in respect of such payment. Claims in respect of any other obligation in respect of the Bonds, including delivery of Shares, shall be prescribed and become void unless made within 10 years following the due date for performance of the relevant obligations. 15.4 Indemnification of Judgment Currency The Issuer will indemnify each Bondholder against loss incurred by such Bondholder as a result of any judgment or order being given or made for any amount due under the Bonds and such judgment or order being expressed and paid in a currency other than euro (the "Judgment Currency") and as a result of any variation as between (i) the rate of exchange at which euro is converted into the Judgment Currency for the purpose of such judgment or order and (ii) the spot rate of exchange in euro at which the Bondholder on the date of payment of such judgment or order is able to purchase euro with the amount of the Judgment Currency actually received by the Bondholder. 15.5 Descriptive Headings The descriptive headings appearing in these Conditions are for convenience of reference only and shall not alter, limit or define the provisions hereof. 15.6 Further Issues The Issuer may from time to time without the consent of the Bondholders create and issue further bonds having the same terms and conditions in all respects as the outstanding Bonds or in all respects except for the first payment of interest on them and the first date on which Conversion Rights may be exercised and so that such further issue shall be consolidated and form a single series with the outstanding Bonds. Any further notes,
74 bonds or debentures forming a single series with the outstanding Bonds constituted by the Trust Deed or any deed supplemental to it shall, and any other notes, bonds or debentures may, with the consent of the Trustee, be constituted by a deed supplemental to the Trust Deed. The Trust Deed contains provisions for convening a single meeting of the Bondholders and the holders of notes, bonds or debentures of other series in certain circumstances where the Trustee so decides. 15.7 Notices All notices required to be given to Bondholders pursuant to these Conditions will (unless otherwise provided in these Conditions) be given by publication through the electronic communication system of Bloomberg. The Issuer shall also ensure that all notices are duly published (if such publication is required) in a manner which complies with the rules and regulations of any stock exchange or other relevant authority on which the Bonds are for the time being listed and/or admitted to trading. Any such notice shall be deemed to have been given on the date of such publication or if required to be published in more than one manner or at different times, then such notice shall be deemed to have been given on the date of the publication in each required manner and time. If publication as provided above is not practicable, notice will be given in such other manner, and shall be deemed to be given on such date, as the Trustee may approve. The Issuer shall send a copy of all notices given by it to Bondholders (or a Bondholder) or the Trustee pursuant to these Conditions simultaneously to the Calculation Agent. 15.8 Governing Law and Jurisdiction (a) Governing Law The Trust Deed, the Agency Agreement and the Bonds and any non-contractual obligations arising out of or in connection with them are governed by, and shall be construed in accordance with, English law. (b) Jurisdiction The courts of England are to have jurisdiction to settle any disputes which may arise out of or in connection with the Trust Deed or the Bonds and accordingly any legal action or proceedings arising out of or in connection with the Trust Deed or the Bonds ("Proceedings") may be brought in such courts. The Issuer has in the Trust Deed irrevocably submitted to the jurisdiction of such courts and has waived any objection to Proceedings in such courts whether on the ground of venue or on the ground that the Proceedings have been brought in an inconvenient forum. This submission is made for the benefit of the Trustee and each of the Bondholders and shall not limit the right of any of them to take Proceedings in any other court of competent jurisdiction nor shall the taking of Proceedings in one or more jurisdictions preclude the taking of Proceedings in any other jurisdiction (whether concurrently or not). (c) Agent for Service of Process The Issuer has irrevocably appointed Process Agent Limited at its registered office for the time being, currently at Kemp House, 152 — 160 City Road, London EC1V 75 2NX as its agent in England to receive service of process in any Proceedings in England. Nothing herein or in the Trust Deed shall affect the right to serve process in any other manner permitted by law. 76 SCHEDULE 2 Form of Original Definitive Registered Bond On the front: ISIN: XS2105716554 THE BONDS REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE U.S. SECURITIES ACT OF 1933, AS AMENDED (THE "SECURITIES ACT") OR WITH ANY SECURITIES REGULATORY AUTHORITY OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES AND MAY NOT BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED EXCEPT IN AN OFFSHORE TRANSACTION IN ACCORDANCE WITH RULE 903 OR RULE 904 OF REGULATION S UNDER THE SECURITIES ACT. PHARMING GROUP N.V. (incorporated with limited liability in the Netherlands with registered number 28048592) €125,000,000 3.00 per cent. Convertible Bonds due 2025 This Bond is a Definitive Registered Bond and forms part of a series designated as specified in the title (the "Bonds") of Pharming Group N.V. (the "Issuer"), with its corporate seat in Leiden. the Netherlands, and constituted by the Trust Deed referred to on the reverse hereof. The Bonds are subject to, and have the benefit of, that Trust Deed and the terms and conditions (the "Conditions") set out on the reverse hereof. The Issuer hereby certifies that [•] is/are, at the date hereof, entered in the Register as the holder(s) of Bonds in the principal amount of €[•]. The Bonds represented by this Definitive Registered Bond are convertible into Shares, as specified in and subject to and in accordance with the Conditions and the Trust Deed. This Definitive Registered Bond is evidence of entitlement only. Title to Bonds passes only on due registration on the Register and only the duly registered holder is entitled to payments in respect of this Definitive Registered Bond. The statements set forth in the legend above are an integral part of the Bonds in respect of which this Definitive Registered Bond is issued and by acceptance thereof each holder or beneficial owner agrees to be subject to and bound by the terms and provisions set forth in such legend. This Definitive Registered Bond and any non-contractual obligations arising out of or in connection with it are governed by, and shall be construed in accordance with, English law. Capitalised terms not defined herein shall have the meaning ascribed thereto in the Trust Deed and the Conditions. 77 In Witness whereof the Issuer has caused this Bond to be signed in facsimile on its behalf. Dated: Authorised Signatory For and on behalf of PHARMING GROUP N.V. Authorised Signatory This Definitive Registered Bond is authenticated without recourse, warranty or liability by or on behalf of the Registrar THE BANK OF NEW YORK MELLON SA/NV, LUXEMBOURG BRANCH By: Authorised Signatory For use by the Principal Paying, Transfer and Conversion Agent: Following the exercise by the Issuer on [•] of its tax redemption option pursuant to Section 4.2 of the Conditions, a Bondholder's Tax Exercise Notice was received by the Principal Paying, Transfer and Conversion Agent on [•] in respect of the Bonds represented by this Definitive Registered Bond. Accordingly, the provisions of Section 6 shall not apply in respect of any payment in respect of principal or interest to be made on such Bonds which falls due after the Tax Redemption Date specified in the Tax Redemption Notice.
78 On the back: Terms and Conditions of the Bonds [THE TERMS AND CONDITIONS THAT ARE SET OUT IN SCHEDULE 1 TO THE TRUST DEED WILL BE SET OUT HERE] 79 Principal Paying, Transfer and Conversion Agent THE BANK OF NEW YORK MELLON. LONDON BRANCH One Canada Square London, E14 5AL Fax: +44 (0) 207 964 2536 Email: corpsov2@bnymellon.com Attention: Corporate Trust Administration Registrar THE BANK OF NEW YORK MELLON SA/NV, LUXEMBOURG BRANCH Vertigo Building — Polaris 2-4 Eugene Ruppert L-2453 Luxembourg Fax: +352 24 52 4204 Attention: Structured Products Services 80 Form of Transfer FOR VALUE RECEIVED the undersigned hereby transfers to (PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS OF TRANSFEREE) (not more than four names may appear as joint holders) €[•] in principal amount of this Bond. and all rights in respect thereof, and irrevocably requests the Registrar to transfer such principal amount of this Bond on the books kept for registration thereof. Dated: Signed: Notes: (i) The signature to this transfer must correspond with the name as it appears on the face of this Bond. (ii) A representative of the Bondholder should state the capacity in which he signs e.g. executor. (iii) The signature of the person effecting a transfer shall conform to any list of duly authorised specimen signatures supplied by the registered holder or be certified by a recognised bank, notary public or in such other manner as the Registrar may require. (iv) Any transfer of Bonds shall be in the minimum amount of €100,000. 81 SCHEDULE 3 Form of Original Global Bond THE BONDS REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE US SECURITIES ACT OF 1933, AS AMENDED (THE "SECURITIES ACT") OR WITH ANY SECURITIES REGULATORY AUTHORITY OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES AND MAY NOT BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED EXCEPT IN AN OFFSHORE TRANSACTION IN ACCORDANCE WITH RULE 903 OR RULE 904 OF REGULATION S UNDER THE SECURITIES ACT. ISIN: XS2105716554 PHARMING GROUP N.V. (incorporated with limited liability in the Netherlands with registered number 28048592) €125,000,000 3.00 per cent. Convertible Bonds due 2025 Global Bond The Bonds in respect of which this Global Bond is issued form part of the series designated as specified in the title (the "Bonds") of Pharming Group N.V. (the "Issuer"), with its corporate seat in Leiden, the Netherlands. The Issuer hereby certifies that The Bank of New York Depository (Nominees) Limited is, at the date hereof, entered in the register of Bondholders as the holder of Bonds in the principal amount of €125,000,000 (ONE HUNDRED AND TWENTY FIVE MILLION EUROS) or such other amount as is shown on the register of Bondholders as being represented by this Global Bond and is duly endorsed (for information purposes only) in the third column of Schedule A to this Global Bond. For value received, the Issuer promises to pay the person who appears at the relevant time on the register of Bondholders as holder of the Bonds in respect of which this Global Bond is issued, such amount or amounts as shall become due and payable from time to time in respect of such Bonds and otherwise to comply with the Conditions referred to below. Each payment will be made to, or to the order of, the person whose name is entered on the Register as holder at the close of business on the record date which shall be on the Clearing System Business Day immediately prior to the date for payment, where "Clearing System Business Day" means Monday to Friday inclusive except 25 December and 1 January. The Bonds are constituted by a trust deed dated 21 January 2020 (the "Trust Deed") between the Issuer, and BNY Mellon Corporate Trustee Services Limited as trustee (the "Trustee") and are subject to the Trust Deed and the terms and conditions (the "Conditions") set out in Schedule 1 to the Trust Deed, as modified by the provisions of this Global Bond. Terms defined in the Trust Deed have the same meaning when used herein. This Global Bond is evidence of entitlement only.
82 Title to the Bonds passes only on due registration on the register of Bondholders and only the duly registered holder is entitled to payments on Bonds in respect of which this Global Bond is issued. Exchange for Definitive Registered Bonds This Global Bond is exchangeable in whole but not in part (free of charge to the holder) for Definitive Registered Bonds if this Global Bond is held on behalf of Euroclear or Clearstream, Luxembourg or the Alternative Clearing System (each as defined under "Notices" below) and any such clearing system is closed for business for a continuous period of 14 days or more (other than by reason of legal holidays) or announces an intention permanently to cease business or does in fact do so by such holder giving notice to the Principal Paying, Transfer and Conversion Agent. On or after the Exchange Date the holder of this Global Bond may surrender this Global Bond to or to the order of the Registrar and, upon such surrender of this Global Bond, the Paying, Transfer and Conversion Agent shall annotate Schedule A hereto. In exchange for this Global Bond, the Issuer shall deliver, or procure the delivery of, an equal aggregate principal amount of duly executed and authenticated Definitive Registered Bonds. "Exchange Date" means a day falling not less than 60 days after that on which the notice requiring exchange is given and on which banks are open for business in the city in which the specified office of the Registrar is located and in the cities in which Euroclear and Clearstream, Luxembourg or, if relevant, the Alternative Clearing System (each as defined under "Notices" below) are located. Except as otherwise described herein, this Global Bond is subject to the Conditions and the Trust Deed and, until it is exchanged for Definitive Registered Bonds, its holder shall be entitled to the same benefits as if it were the holder of the Definitive Registered Bonds for which it may be exchanged and as if such Definitive Registered Bonds had been issued on the date of this Global Bond. The Conditions shall be modified with respect to Bonds represented by this Global Bond by the following provisions: Notices So long as this Global Bond is held on behalf of Euroclear Bank SA/NV ("Euroclear") or Clearstream Banking S.A. ("Clearstream, Luxembourg") or such other clearing system as shall have been approved by the Trustee (the "Alternative Clearing System"), notices required to be given to Bondholders may be given by their being delivered to Accountholders (as defined below) through Euroclear and Clearstream, Luxembourg or, as the case may be, the Alternative Clearing System, rather than by notification to Bondholders as required by the Conditions in which case such notices shall be deemed to have been given to Bondholders on the date of delivery to Accountholders through Euroclear and Clearstream, Luxembourg or, as the case may be, the Alternative Clearing System. Prescription Any claim in respect of principal, interest and other amounts payable in respect of this Global Bond will become void unless made within 10 years (in the case of principal or any other amount (other than interest)) or five years (in the case of interest) from the appropriate Relevant Date (as defined in Section 14 of the Conditions) in respect of such payment. 83 Conversion For so long as this Global Bond is held on behalf of any one or more of Euroclear, Clearstream, Luxembourg or the Alternative Clearing System, Conversion Rights (as defined in the Conditions) may be exercised as against the Issuer at any time during the Conversion Period (as defined in the Conditions), as provided in Section 5.1 of the Conditions, by the delivery to or to the order of the Principal Paying, Transfer and Conversion Agent in accordance with the standard procedures of Euroclear, Clearstream, Luxembourg or the Alternative Clearing System of one or more Conversion Notices duly completed by or on behalf of a holder of a book-entry interest representing entitlements to the Global Bond (each such person, an "Accountholder"). Upon exercise of any Conversion Rights, the Paying, Transfer and Conversion Agent shall annotate Schedule A hereto accordingly. Trustee's Powers Notwithstanding anything in the Trust Deed, in considering the interests of Bondholders while the Global Bond is held on behalf of a clearing system, the Trustee may have regard to any information provided to it by such clearing system or its operator as to the identity (either individually or by category) of its Accountholders and may consider such interests and treat such Accountholders as if such Accountholders were holders of the Global Bond. Redemption at the Option of Bondholders The option of the Bondholders provided for in Section 4.3 of the Conditions, may be exercised by the delivery by an Accountholder of a duly completed notice to the Principal Paying, Transfer and Conversion Agent in accordance with the standard procedures of Euroclear, Clearstream, Luxembourg or the Alternative Clearing System within the time limits set out in Section 4.3 of the Conditions, substantially in the form of the Put Exercise Notice, available from the Principal Paying, Transfer and Conversion Agent and stating the principal amount of the Bonds in respect of which the option is exercised. Upon exercise of such option, the Paying, Transfer and Conversion Agent shall annotate Schedule A hereto accordingly. Redemption at the Option of the Issuer The options of the Issuer provided for in Section 4.1 and Section 4.2 of the Conditions shall be exercised by the Issuer giving notice to the Accountholders through Euroclear and Clearstream, Luxembourg or, as the case may be. the Alternative Clearing System within the time limits set out in, and containing the information required by, Section 4.1 of the Conditions or, as the case may be, Section 4.2 of the Conditions. Upon exercise of such option and, in the case of Section 4.2 of the Conditions, subject to the option of the Bondholders provided for in Section 4.2 of the Conditions, the Principal Paying, Transfer and Conversion Agent shall annotate Schedule A hereto accordingly. Purchase and Cancellation Cancellation of any Bond represented by this Global Bond which is required by the Conditions to be cancelled will be effected by reduction in the principal amount of this Global Bond on its presentation to or to the order of the Principal Paying, Transfer and Conversion Agent for notation in Schedule A hereto. 84 Bondholder's Tax Option The option of the Bondholders provided for in Section 4.2 of the Conditions shall be exercised by the delivery by an Accountholder of a duly completed Bondholder's Tax Exercise Notice in accordance with the standard procedures of Euroclear, Clearstream, Luxembourg or the Alternative Clearing System within the time limits set out in and containing the information required by Section 4.2 to the Principal Paying, Transfer and Conversion Agent. Upon exercise of such option, the Principal Paying, Transfer and Conversion Agent shall annotate Schedule A hereto accordingly. The statements set forth in the legend above are an integral part of the Bonds in respect of which this Global Bond is issued and by acceptance thereof each holder or beneficial owner agrees to be subject to and bound by the terms and provisions set forth in such legend. This Global Bond shall not be valid or become obligatory for any purpose until authenticated by or on behalf of the Registrar. This Global Bond and any non-contractual obligations arising out of or in connection with it are governed by and shall be construed in accordance with English law. In witness whereof the Issuer has caused this Global Bond to be signed on its behalf. Dated: PHARMING GROUP N.V. Authorised Signatory Authorised Signatory This Global Bond is authenticated without recourse, warranty or liability by or on behalf of the Registrar. THE BANK OF NEW YORK MELLON SA/NV. LUXEMBOURG BRANCH By: Authorised Signatory 85 Schedule A Schedule of Reductions in Principal Amount of Bonds in respect of which this Global Bond is Issued The following reductions in the principal amount of the Bonds in respect of which this Global Bond is issued have been made as a result of: (i) exercise of the Conversion Right attaching to the Bonds, or (ii) redemption of the Bonds, or (iii) purchase and cancellation of the Bonds or (iv) issue of Definitive Registered Bonds in respect of the Bonds: Date of Conversion/ Redemption/Purchase and Cancellation/ Issue of Definitive Registered Bonds (stating which) Amount of decrease in principal amount of this Global Bond (€) Principal Amount of this Global Bond following such decrease ((€) Notation made by or on behalf of the Principal Paying, Transfer and Conversion Agent
86 Form of Transfer FOR VALUE RECEIVED the undersigned hereby transfers to (PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS OF TRANSFEREE) (not more than four names may appear as joint holders) €[•] in principal amount of this Bond. and all rights in respect thereof, and irrevocably requests the Registrar to transfer such principal amount of this Bond on the books kept for registration thereof. Dated Signed Notes: (I) The signature to this transfer must correspond with the name as it appears on the face of this Bond. (ii) A representative of the Bondholder should state the capacity in which he signs e.g. executor. (iii) The signature of the person effecting a transfer shall conform to any list of duly authorised specimen signatures supplied by the registered holder or be certified by a recognised bank, notary public or in such other manner as the Registrar may require. (iv) Any transfer of Bonds shall be in the minimum amount of €100,000. 87 SCHEDULE 4 Provisions for Meetings of Bondholders Interpretation 1.1 In this Schedule the following expressions have the following meanings: 1.2 "Electronic Consent" has the meaning set out in paragraph 20; 1.3 "Extraordinary Resolution" means a resolution passed (i) at a meeting of Bondholders duly convened and held in accordance with these provisions by or on behalf of the Bondholder(s) of not less than three-fourths of the persons eligible to vote at such meeting, (ii) by a Written Resolution or (iii) by an Electronic Consent: and 1.4 "Written Resolution" means a resolution in writing signed by or on behalf of Bondholders representing in aggregate not less than three-fourths in principal amount of the Bonds for the time being outstanding. 2 2.1 A holder of a Bond may by an instrument in writing (a "form of proxy") in the form available from the specified office of any Agent in English signed by the holder or, in the case of a corporation, executed under its common seal or signed on its behalf by an attorney or a duly authorised officer of the corporation and delivered to any Agent not later than 48 hours before the time fixed for any meeting, appoint any person as (a "proxy") to act on his or its behalf in connection with any meeting or proposed meeting of Bondholders. 2.2 A holder of a Bond which is a corporation may by delivering to any Agent not later than 48 hours before the time fixed for any meeting a resolution of its directors or other governing body in English authorise any person to act as its representative (a "representative") in connection with any meeting or proposed meeting of Bondholders. 2.3 Any proxy appointed pursuant to paragraph 2.1 above or representative appointed pursuant to paragraph 2.2 above shall so long as such appointment remains in force be deemed, for all purposes in connection with any meeting or proposed meeting of Bondholders specified in such appointment, to be the holder of the Bonds to which such appointment relates and the holder of the Bonds shall be deemed for such purposes not to be the holder. The Issuer and the Trustee shall be entitled to assume that any proxy has been validly appointed and that such appointment remains in effect unless notice of revocation is given to the Issuer at its registered office not less than 24 hours prior to the time fixed for the meeting or, thereafter, to the chairman of the meeting. 2.4 Forms of proxy shall be valid for so long as the relevant Bonds shall be duly registered in the name(s) of the registered holder(s) certified in the name of the appointor but not otherwise and notwithstanding any other provision of this Schedule 4 and during the validity thereof the proxy shall, for all purposes in connection with any meeting of holders of Bonds, be deemed to be the holder of the Bonds to which such form of proxy relates. 3 Each of the Issuer and the Trustee (subject to its being indemnified and/or secured and/or pre-funded to its satisfaction) at any time may, and the Issuer, upon a request in writing of 88 Bondholders holding not less than one-tenth in principal amount of the Bonds for the time being outstanding shall, convene a meeting of Bondholders. Whenever any such party is about to convene any such meeting, it shall promptly give notice in writing to each other party of the day, time and place of the meeting and of the nature of the business to be transacted at it. Every such meeting shall be held at such time and place as the Trustee may approve. 4 At least 21 days' notice (exclusive of the day on which the notice is given and of the day on which the meeting is held) specifying the day, time and place of meeting shall be given to the Bondholders (with a copy to the Trustee where such meeting was convened by the Issuer or to the Issuer where such meeting was convened by the Trustee). Such notice shall also specify, unless the Trustee otherwise agrees, the nature of the resolutions to be proposed. 5 A meeting that has been validly convened in accordance with paragraph 4 above, may be cancelled by the person who convened such meeting by giving at least 7 days' notice (exclusive of the day on which the notice is given or deemed to be given and of the day of the meeting) to the Bondholders (with a copy to the Trustee where such meeting was convened by the Issuer or to the Issuer where such meeting was convened by the Trustee). Any meeting cancelled in accordance with this paragraph 5 shall be deemed not to have been convened. 6 A person (who may, but need not, be a Bondholder) nominated in writing by the Trustee may take the chair at every such meeting but if no such nomination is made or if at any meeting the person nominated shall not be present within 15 minutes after the time fixed for the meeting, the Bondholders present shall choose one of their number to be chairman, failing which the Issuer may appoint a chairman. The chairman of an adjourned meeting need not be the same person as was chairman of the original meeting. 7 At any such meeting any one or more persons present in person holding Bonds or being proxies or representatives and holding or representing in the aggregate more than one- tenth in principal amount of the Bonds for the time being outstanding shall (except for the purpose of passing an Extraordinary Resolution) form a quorum for the transaction of business and no business (other than the choosing of a chairman) shall be transacted at any meeting unless the requisite quorum be present at the commencement of business. The quorum at any such meeting for passing an Extraordinary Resolution shall (subject as provided below) be one or more persons present in person holding Bonds or being proxies or representatives and holding or representing in the aggregate more than one- half in principal amount of the Bonds for the time being outstanding; provided that at any meeting the business of which includes any of the matters specified in the proviso to paragraph 17.7, the quorum shall be one or more persons present in person holding Bonds or being proxies or representatives and holding or representing in the aggregate not less than two-thirds in principal amount of the Bonds for the time being outstanding. 8 If within 15 minutes from the time fixed for any such meeting a quorum is not present, the meeting shall, if convened upon the requisition of Bondholders, be dissolved. In any other case it shall stand adjourned (unless the Issuer and the Trustee agree that it be dissolved) for such period. not being less than 14 days nor more than 42 days, and to such place, as may be decided by the chairman. At such adjourned meeting one or more persons present in person holding Bonds or voting certificates or being proxies or representatives (whatever the principal amount of the Bonds so held or represented) shall form a quorum 89 and may pass any resolution and decide upon all matters which could properly have been dealt with at the meeting from which the adjournment took place had a quorum been present at such meeting; provided that at any adjourned meeting at which is to be proposed an Extraordinary Resolution for the purpose of effecting any of the modifications specified in the proviso to paragraph 17.7, the quorum shall be one or more persons so present holding Bonds or being proxies or representatives and holding or representing in the aggregate not less than one- third in principal amount of the Bonds for the time being outstanding. If a quorum is not present within 15 minutes from the time fixed for a meeting so adjourned, the meeting shall be dissolved. 9 The chairman may with the consent of (and shall if directed by) any meeting adjourn such meeting from time to time and from place to place but no business shall be transacted at any adjourned meeting except business which might lawfully have been transacted at the meeting from which the adjournment took place. 10 At least 10 days' notice (exclusive of the day on which the notice is given and of the day of the adjourned meeting) of any meeting adjourned through want of a quorum shall be given in the same manner as for an original meeting and such notice shall state the quorum required at such adjourned meeting. It shall not, however, otherwise be necessary to give any notice of an adjourned meeting. 11 Every question submitted to a meeting shall be decided in the first instance by a show of hands and in case of equality of votes the chairman shall both on a show of hands and on a poll have a casting vote in addition to the vote or votes (if any) which he may have as a Bondholder or as a proxy or representative. 12 At any meeting, unless a poll is (before or on the declaration of the result of the show of hands) demanded by the chairman, the Issuer. the Trustee or by one or more persons holding one or more Bonds or being proxies or representatives and holding or representing in the aggregate not less than one-fiftieth in principal amount of the Bonds for the time being outstanding, a declaration by the chairman that a resolution has been carried or carried by a particular majority or lost or not carried by any particular majority shall be conclusive evidence of the fact without proof of the number or proportion of the votes recorded in favour of or against such resolution. 13 If at any meeting a poll is so demanded, it shall be taken in such manner and (subject as provided below) either at once or after such an adjournment as the chairman directs and the result of such poll shall be deemed to be the resolution of the meeting at which the poll was demanded as at the date of the taking of the poll. The demand for a poll shall not prevent the continuation of the meeting for the transaction of any business other than the question on which the poll has been demanded. 14 Any poll demanded at any meeting on the election of a chairman or on any question of adjournment shall be taken at the meeting without adjournment. 15 The Issuer and the Trustee (through their respective representatives) and their respective financial and legal advisers may attend and speak at any meeting of Bondholders. No one else may attend at any meeting of Bondholders or join with others in requesting the
90 convening of such a meeting unless he is the holder of a Bond or is a proxy or a representative. 16 At any meeting on a show of hands every person who is present in person and who produces a Bond or is a proxy or a representative shall have one vote and on a poll every person who is so present shall have one vote in respect of each €1 (or, in the case of meetings of holders of Bonds denominated in another currency, as the Trustee in its absolute discretion may decide) in principal amount of the Bonds so produced or represented or in respect of which he is a proxy or a representative. Without prejudice to the obligations of proxies, any person entitled to more than one vote need not use all his votes or cast all the votes to which he is entitled in the same way. 17 A meeting of Bondholders shall, subject to the Conditions, in addition to the powers given above, but without prejudice to any powers conferred on other persons by this Trust Deed, have power exercisable by Extraordinary Resolution: 17.1 to sanction any proposal by the Issuer or the Trustee for any modification, abrogation, variation or compromise of, or arrangement in respect of, the rights of the Bondholders against the Issuer or against any of its property whether such rights shall arise under this Trust Deed, the Agency Agreement or otherwise: 17.2 to sanction any scheme or proposal for the exchange or sale of the Bonds for, or the conversion of the Bonds into, or the cancellation of the Bonds in consideration of, shares, stock, notes, bonds, debentures, debenture stock and/or other obligations and/or securities of the Issuer or any other body corporate formed or to be formed, or partly for or into or in consideration of such shares, stock. notes. bonds, debentures, debenture stock and/or other obligations and/or securities as aforesaid: 17.3 to assent to any modification of this Trust Deed or the Conditions that relate to the rights appertaining to the Bonds which shall be proposed by the Issuer or the Trustee; 17.4 to authorise anyone to concur in and do all such things as may be necessary to carry out and to give any authority, direction or sanction which under this Trust Deed or the Bonds is required to be given by Extraordinary Resolution; 17.5 to appoint any persons (whether Bondholders or not) as a committee or committees to represent the interests of the Bondholders and to confer upon such committee or committees any powers or discretions which the Bondholders could themselves exercise by Extraordinary Resolution; 17.6 to approve a person proposed to be appointed as a new Trustee and to remove any Trustee; and 17.7 to discharge or exonerate the Trustee from any liability in respect of any act or omission for which it may become responsible under this Trust Deed or the Bonds; provided that the special quorum provisions contained in the proviso to paragraph 7 and, in the case of an adjourned meeting, in the proviso to paragraph 8 shall apply in relation to any Extraordinary Resolution for the purpose of paragraph 17.2 or for the purpose of making any modification to the provisions contained in this Trust Deed, the Conditions or the Bonds which would have the effect of: 91 17.7.1 changing the Maturity Date or the dates on which interest is payable in respect of the Bonds; or 17.7.2 modifying the circumstances in which the Issuer or Bondholders are entitled to redeem the Bonds pursuant to Sections 4.1, 4.2 or 4.3 of the Conditions (other than removing the right of the Issuer to redeem the Bonds pursuant to Sections 4.1 or 4.2 of the Conditions): or 17.7.3 reducing or cancelling the principal amount of, or interest on, the Bonds or to reduce the amount payable on redemption of the Bonds; or 17.7.4 modifying the basis for calculating the interest payable in respect of the Bonds; or 17.7.5 modifying the provisions relating to. or cancelling, the Conversion Rights or the rights of Bondholders to receive Shares on exercise of Conversion Rights pursuant to the Conditions (other than a reduction to the Conversion Price); or 17.7.6 increasing the Conversion Price (other than in accordance with the Conditions); or 17.7.7 changing the currency of the denomination of the Bonds or any payment in respect of the Bonds: or 17.7.8 changing the governing law of the Bonds, the Trust Deed or the Agency Agreement: or 17.7.9 modifying the provisions concerning the quorum required at any meeting of Bondholders or the majority required to pass an Extraordinary Resolution; or 17.7.10 amending this proviso. 18 An Extraordinary Resolution passed at a meeting of Bondholders duly convened and held in accordance with this Trust Deed shall be binding upon all the Bondholders, whether or not present at such meeting and whether or not they vote in favour, and each of the Bondholders shall be bound to give effect to it accordingly. The passing of any such resolution shall be conclusive evidence that the circumstances of such resolution justify the passing of it. 19 Minutes of all resolutions and proceedings at every such meeting shall be made and entered in the books to be from time to time provided for that purpose by the Issuer or the Trustee and any such minutes, if purporting to be signed by the chairman of the meeting at which such resolutions were passed or proceedings transacted or by the chairman of the next succeeding meeting of Bondholders, shall be conclusive evidence of the matters contained in them and until the contrary is proved every such meeting in respect of the proceedings of which minutes have been so made and signed shall be deemed to have 92 been duly convened and held and all resolutions passed or proceedings transacted at it to have been duly passed and transacted. 20 Subject to the following sentence. a Written Resolution may be contained in one document or in several documents in like form, each signed by or on behalf of one or more of the Bondholders. For so long as the Bonds are in the form of a Global Bond registered in the name of a common depositary for Euroclear, Clearstream, Luxembourg or another clearing system, or a nominee of any of the above then. in respect of any resolution proposed by the Issuer or the Trustee: 20.1 Electronic Consent: where the terms of the resolution proposed by the Issuer or the Trustee (as the case may be) have been notified to the Bondholders through the relevant clearing system(s) as provided in sub-paragraphs (i) and/or (ii) below, each of the Issuer and the Trustee shall be entitled to rely upon approval of such resolution given by way of electronic consents communicated through the electronic communications systems of the relevant clearing system(s) to the Principal Paying, Transfer and Conversion Agent or another specified agent and/or the Trustee in accordance with their operating rules and procedures by or on behalf of the Bondholder(s) of not less than 75 per cent. in principal amount of the Bonds for the time being outstanding (the "Required Proportion") ("Electronic Consent") by close of business on the Relevant Date. Any resolution passed in such manner shall be binding on all Bondholders even if the relevant consent or instruction proves to be defective. Neither the Issuer nor the Trustee shall be liable or responsible to anyone for such reliance; (i) When a proposal for a resolution to be passed as an Electronic Consent has been made, at least 10 days' notice (exclusive of the day on which the notice is given and of the day on which affirmative consents will be counted) shall be given to the Bondholders through the relevant clearing system(s). The notice shall specify, in sufficient detail to enable Bondholders to give their consents in relation to the proposed resolution, the method by which their consents may be given (including, where applicable, blocking of their accounts in the relevant clearing system(s)) and the time and date (the "Relevant Date") by which they must be received in order for such consents to be validly given, in each case subject to and in accordance with the operating rules and procedures of the relevant clearing system(s). (ii) If, on the Relevant Date on which the consents in respect of an Electronic Consent are first counted, such consents do not represent the Required Proportion, the resolution shall. if the party proposing such resolution (the "Proposer") so determines, be deemed to be defeated. Such determination shall be notified in writing to the other party or parties to the Trust Deed. Alternatively, the Proposer may give a further notice to Bondholders that the resolution will be proposed again on such date and for such period as shall be agreed with the Trustee (unless the Trustee is the Proposer). Such notice must inform Bondholders that insufficient consents were received in relation to the original resolution and the information specified in sub-paragraph (i) above. For the purpose of such further notice, references to "Relevant Date" shall be construed accordingly. For the avoidance of doubt, an Electronic Consent may only be used in relation to a resolution proposed by the Issuer or the Trustee which is not then the subject of a meeting that has been 93 validly convened in accordance with paragraph 3 above, unless that meeting is or shall be cancelled or dissolved; and 20.2 Written Resolution: where Electronic Consent is not being sought, for the purpose of determining whether a Written Resolution has been validly passed, the Issuer and the Trustee shall be entitled to rely on consent or instructions given in writing directly to the Issuer and/or the Trustee, as the case may be, (a) by accountholders in the clearing system with entitlements to such Global Bond or, (b) where the accountholders hold any such entitlement on behalf of another person, on written consent from or written instruction by the person identified by that accountholder as the person for whom such entitlement is held. For the purpose of establishing the entitlement to give any such consent or instruction, the Issuer and the Trustee shall be entitled to rely on any certificate or other document issued by, in the case of (a) above. Euroclear, Clearstream. Luxembourg or any other relevant alternative clearing system (the "relevant clearing system") and, in the case of (b) above, the relevant clearing system and the accountholder identified by the relevant clearing system for the purposes of (b) above. Any resolution passed in such manner shall be binding on all Bondholders, even if the relevant consent or instruction proves to be defective. Any such certificate or other document shall be conclusive and binding for all purposes. Any such certificate or other document may comprise any form of statement or print out of electronic records provided by the relevant clearing system (including Euroclear's EUCLID or Clearstream. Luxembourg's CreationOnline system) in accordance with its usual procedures and in which the accountholder of a particular principal or nominal amount of the Bonds is clearly identified together with the amount of such holding. Neither the Issuer nor the Trustee shall be liable to any person by reason of having accepted as valid or not having rejected any certificate or other document to such effect purporting to be issued by any such person and subsequently found to be forged or not authentic. A Written Resolution and/or Electronic Consent shall take effect as an Extraordinary Resolution. A Written Resolution and/or Electronic Consent will be binding on all Bondholders, whether or not they participated in such Written Resolution and/or Electronic Consent. 21 Subject to all other provisions contained in this Trust Deed the Trustee may without the consent of the Bondholders prescribe such further regulations regarding the holding of meetings of Bondholders and attendance and voting at them as the Trustee may in its sole discretion determine including particularly (but without prejudice to the generality of the foregoing) such regulations and requirements as the Trustee thinks reasonable: 21.1 so as to satisfy itself that persons who purport to requisition a meeting in accordance with paragraph 3 or who purport to make any requisition to the Trustee in accordance with this Trust Deed are in fact Bondholders; and 21.2 so as to satisfy itself that persons who purport to attend or vote at any meeting of Bondholders are entitled to do so in accordance with this Trust Deed. 22 If and whenever the Issuer shall have issued and have outstanding any Bonds which are not identical and do not form one single series then those Bonds which are in all respects
94 identical shall be deemed to constitute a separate series of the Bonds and the foregoing provisions of this Schedule shall have effect subject to the following modifications: 22.1 a resolution which in the opinion of the Trustee affects one series only of the Bonds shall be deemed to have been duly passed if passed at a separate meeting of the holders of the Bonds of that series; 22.2 a resolution which in the opinion of the Trustee affects more than one series of the Bonds but does not give rise to a conflict of interest between the holders of Bonds of any of the series so affected shall be deemed to have been duly passed if passed at a single meeting of the holders of the Bonds of all the series so affected; 22.3 a resolution which in the opinion of the Trustee affects more than one series of the Bonds and gives or may give rise to a conflict of interest between the holders of the Bonds of any of the series so affected shall be deemed to have been duly passed only if it shall be duly passed at separate meetings of the holders of the Bonds of each series so affected: and 22.4 to all such meetings as aforesaid all the preceding provisions of this Schedule shall mutatis mutandis apply as though references therein to Bonds and holders were references to the Bonds of the series or group of series in question and to the holders of such Bonds respectively. 23 Nothing in this Trust Deed shall prevent any of the proxies named in any form of proxy from being a director, managing director, officer or representative of, or otherwise connected with, the Issuer or any of its Subsidiaries. 24 References in this Schedule to Agents shall, where the context requires, be taken to be references to Principal Paying, Transfer and Conversion Agent. 95 SCHEDULE 5 Form of Directors' Certificate [ON THE HEADED PAPER OF THE ISSUER] To: BNY Mellon Corporate Trustee Services Limited One Canada Square London E14 5AL United Kingdom 21 January 2020 Dear Sirs PHARMING GROUP N.V. €125,000,000 3.00 per cent. Convertible Bonds due 2025 This certificate is delivered to you in accordance with Clause 10.5 of the Trust Deed dated 21 January 2020 (the "Trust Deed") and made between Pharming Group N.V. (the "Issuer") and BNY Mellon Corporate Trustee Services Limited (the "Trustee"). All words and expressions defined in the Trust Deed shall (save as otherwise provided herein or unless the context otherwise requires) have the same meanings herein. The undersigned. to the best of their knowledge, information and belief having made all reasonable enquiries: (a) As at [•]1, no Potential Event of Default, Event of Default or Change of Control or Delisting Event existed [other than [•]]2 and no Potential Event of Default, Event of Default or Change of Control or Delisting Event had existed at any time since [•]3 [the Certification Date (as defined in the Trust Deed) of the last certificate delivered under Clause 10.54]/[the date of this Trust Deed] [other than [•]]5; and (b) From and including [•]3 [the Certification Date of the last certificate delivered under Clause 10.5]4/[the date of this Trust Deed] to and including [•]1, the [Issuer] confirms that there has been no breach in respect of its obligations under the Trust Deed [other than [•]]6 and that no Change of Control or Delisting Event [other than [•]]7 has occurred. 1 Specify a date not more than 5 days before the date of delivery of the certificate. 2 If any Event of Default or Potential Event of Default did exist, give details; otherwise delete. 3 Insert date of Trust Deed in respect of the first certificate delivered under Clause 10.5, otherwise delete. 4 Include unless the certificate is the first certificate delivered under Clause 10.5, in which case delete. 5 If any Event of Default or Potential Event of Default did exist, give details: otherwise delete. 6 If the Issuer has failed to comply with any obligation(s), give details; otherwise delete. 7 If a Change of Control or Delisting Event has occurred, give details; otherwise delete. 96 For and on behalf of Director Director 97 This deed is delivered on the day and year first before written. EXECUTED AS A DEED BY PHARMING GROUP N.V. By: /s/ Sijmen de Vries Authorised signatory and /s/ Robin Wright Authorised signatory
98 EXECUTED AND DELIVERED AS A DEED BY BNY MELLON CORPORATE TRUSTEE SERVICES LIMITED Acting by two of its lawful Attorneys: Attorney: /s/ Michael Lee Attorney: /s/ Martin Olcese In the presence of: /s/ Marco Thuo Address: One Canada Square, London E14 5AL
EX-4
6
pharming-exhibit47_04apr.htm
EX-4.7 ORCHARD
pharming-exhibit47_04apr
Exhibit 4.7 THE SYMBOL [____] DENOTES PLACES WHERE CERTAIN INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. RESEARCH COLLABORATION AND LICENCE AGREEMENT by and between ORCHARD THERAPEUTICS (EUROPE) LIMITED and PHARMING TECHNOLOGIES B.V. Dated as of 1 July 2021 1 THIS RESEARCH COLLABORATION AND LICENCE AGREEMENT is made and entered into effective as of 1 July 2021 (the “Effective Date”) by and between (1) ORCHARD THERAPEUTICS (EUROPE) LIMITED, a company organized under the laws of England and Wales, and with its office at 108 Cannon Street, London EC4A 6EU (“Orchard”), and (2) PHARMING TECHNOLOGIES B.V, a company organized under the laws of the Netherlands with its office at Darwinweg 24, 2333 CR Leiden, The Netherlands (“Pharming”). Orchard and Pharming are sometimes referred to herein individually as a “Party” and collectively as the “Parties”. BACKGROUND (A) Orchard is a global, commercial stage biopharmaceutical company developing innovative gene therapies and owns or Controls certain intellectual property rights with respect to the research and development of haematopoietic stem cell lentivirus-mediated gene therapy. (B) Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. (C) The Parties have agreed to collaborate to research, develop, and manufacture an ex vivo autologous haematopoietic stem cell lentivirus-mediated gene therapy, which Pharming will commercialise, all as further set out herein. NOW, THEREFORE, in consideration of the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows: 2 ARTICLE 1 DEFINITIONS As used in this Agreement, the following capitalized terms, whether used in the singular or plural, shall have the meanings set out below: 1.1 “Acceptance of a Drug Approval Application by the FDA” as used in Section 9.3.1 (Development Milestone Payments) means a determination by the FDA that the Drug Approval Application is sufficiently complete to permit a substantive review (consistent with the definition in 21 C.F.R. § 314.101(a) of the “filing” of an NDA). 1.2 “Accounting Standards” means, with respect to each Party, International Financial Reporting Standards (IFRS). 1.3 “Additional Competitive Program” means both (i) any Competitive Program, and/or (ii) the research, development, promotion, regulatory approval or commercialisation of any haematopoietic stem cell gene therapy product. 1.4 “Affiliate” means, with respect to a Party or other Person, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party or such other Person. For the purposes of this definition, “control” and, with correlative meanings, the terms “controlling”, “controlled by” and “under common control with”, means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). 1.5 “Agreement” means this agreement and all schedules, appendices and other addenda attached hereto as any of the foregoing may be amended in accordance with the provisions of this Agreement. 1.6 “Alliance Manager” has the meaning set forth in Section 2.10. 3 1.7 “Annual Net Sales” means the total Net Sales of the Licensed Product in a particular Year or, with respect to the Year that includes the First Commercial Sale, the period beginning on such date of First Commercial Sale through to the end of the Year in which such First Commercial Sale occurred. 1.8 “Anti-Corruption Laws” has the meaning set forth in Section 13.3.4. 1.9 “Applicable Law” means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Governmental Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder. 1.10 “Business Day” means a day other than a Saturday or Sunday on which banking institutions in Amsterdam, The Netherlands, New York, the United States of America, and London, England are open for business. 1.11 “Centralized Approval Procedure” means the procedure through which an MAA filed with the EMA results in a single marketing authorization valid throughout the European Union. 1.12 “Change of Control” means, with respect to a Party: (a) a transaction in which such Party (or a Holding Company of such Party) sells, conveys or otherwise disposes of all or substantially all of its property or business; or (b) (i) a transaction in which such Party (or a Holding Company of such Party) merges or consolidates with any other Person (other than a wholly-owned subsidiary of such Party or a Holding Company of such Party), or (ii) any other transaction or series of transactions; in each case of clause (i) or (ii), in consequence of which any Person and/or any group of Persons acting in concert (as such expression is defined in the Code) acquires a Controlling Interest in such Party (or in a Holding Company of such Party). For the purposes of Sections 1.12 or 1.107, the following capitalized terms shall have the meanings set out below:
4 “Code” means the UK City Code on Takeovers and Mergers; “Controlling Interest” means an interest in shares giving to the holder or holders the power to secure (a) by means of the holding of shares or the possession of voting power in relation to that or any other body corporate and/or (b) as a result of any powers conferred by the articles of association or other document regulating that or any other body corporate (i) the election of a majority of the members of the company’s board of directors or similar governing body and/or (ii) that the affairs of the company are conducted in accordance with such holder or holder’s wishes; and “Holding Company” has the meaning given to “holding company” in section 1159 of the Companies Act 2006. 1.13 “Claims” has the meaning set forth in Section 14.1. 1.14 “Clinical Development Plan” means the plan setting out: (i) the clinical development activities to be performed by or on behalf of Pharming, (ii) the Manufacturing activities and technology and knowledge transfer obligations to be performed by Orchard, and (iii) any relevant development activities with respect to NTCR performed by either Party or both Parties, as such plan is approved by the JSC in accordance with Section 2.2.5, and as amended by the JSC from time to time in accordance with Section 2.2.5. 1.15 “Clinical Studies” means any and all Phase 1 Trials, Phase 2 Trials, Phase 3 Trials, Phase 4 Trials and Pivotal Studies and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by any applicable Regulatory Authority, to obtain or maintain Regulatory Approvals for the Licensed Product, including such tests or studies that are intended to expand the approved indications for the Licensed Product. 1.16 “Collaboration” means the collaboration between the Parties with respect to the Licensed Products which is the subject matter of this Agreement. 1.17 “Commercialization” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of any Licensed Product, including activities related to 5 marketing, promoting, distributing, importing and exporting such product, and, for the purposes of setting forth the rights and obligations of the Parties under this Agreement, shall be deemed to include conducting medical affairs activities and conducting Phase 4 Trials, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning. 1.18 “Commercially Reasonable Efforts” means: 1.18.1 with respect to a Party’s activities, the carrying out of such activities using efforts and resources that such Party and its Affiliates would typically devote to carrying out such activities, acting in good faith, to products of similar market potential at a similar stage in development or product life, taking into account all scientific, commercial and other factors that such Party and its Affiliates would typically take into account, including (i) [_____], (ii) the [_____], (iii) [_____], (iv) actual or anticipated [_____], (v) the expected and actual [_____], (vi) expected and actual [_____], (vii) expected and actual [_____], (viii) and the nature and extent of expected and actual [_____], (ix) the expected and actual [_____] and (x) the expected and actual amounts of [_____]; provided, that in any event such efforts and resources shall be no less than the efforts used by similarly situated and reputable companies in each Party’s respective industry (taking into account the foregoing scientific, commercial and other factors); and 1.18.2 with respect to an activity that is subcontracted by such Party or any of its Affiliates to a Third Party as permitted hereunder, the exercise of such care and the dedication of such efforts by such Party or its Affiliate with respect to (a) the selection of such Third Party, (b) the entry into the subcontract with such Third Party (including with respect to the terms thereof), and (c) the management of such subcontract, in each case ((a), (b), and (c)), as are consistent with the standards typically applied by the relevant subcontracting Party and, in any event, such Party shall procure that such Third Party shall 6 perform such subcontracted activities with at least the level of efforts and resources required of such Party as set forth in Section 1.18.1 as if such subcontractor were such Party. 1.19 “Competitive Infringement” has the meaning set forth in Section 11.3.1. 1.20 “Competitive Program” has the meaning set forth in Section 4.1. 1.21 “Conditioning Regimen” means any treatment used to [_____] in a patient prior to administration of the Licensed Product. 1.22 “Confidential Information” means any Information or data provided orally, visually, in writing or other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement, whether prior to, on, or after the Effective Date, including Information relating to the terms of this Agreement, any Licensed Product, any Exploitation of any Licensed Product, any Know-How with respect thereto developed by or on behalf of the disclosing Party or its Affiliates (including Pharming Collaboration Know-How and Orchard Collaboration Know-How, as applicable), or the scientific, regulatory, or business affairs or other activities of either Party. Notwithstanding the foregoing, (a) Orchard Background IP, Orchard Collaboration IP, Orchard Conditioning IP and Platform IP will be considered Confidential Information of Orchard, (b) Pharming Background IP, Pharming Collaboration IP and Pharming Conditioning IP will be considered Confidential Information of Pharming, and (c) Joint Collaboration IP and Joint Conditioning IP shall be considered the Confidential Information of both Parties and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto. 1.23 “Control” means, with respect to any item of Information, Know-How, material, Patent, or other property right and a Party or its Affiliates, the possession by such Party or its Affiliates of the right, whether directly or indirectly, and whether by ownership, license, covenant not to sue, or otherwise (other than by operation of the licence and other grants in this Agreement), to grant a license, sublicense, or other right to or under such 7 Information, Know-How, material, Patent, or other property right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party; provided, however, that, with respect to any of the foregoing that is in-licensed by such Party or its Affiliates from a Third Party, if (a) the grant to the other Party of access to or a license under such item or right and/or (b) the exercise by the other Party of rights under such license, as provided herein, in either case ((a) or (b)), would trigger a payment obligation by a Party to a Third Party, such item or right, as applicable, shall: (A) if such Party is Orchard, only be deemed Controlled by Orchard if: (i) Pharming agrees in writing and executes a mutually acceptable agreement confirming that Pharming shall be responsible for such payment obligations to the extent resulting from such grant of access or license to Pharming and/or such exercise by Pharming of such rights under such license, and any other obligations required by the respective Third Party under the applicable licence agreement between Orchard and such Third Party as a condition of such sublicence; and (ii) solely in the case of any Know-How or Patent that constitutes Manufacturing Process Improvements, to the extent disclosed by Orchard under Section 2.2.7 or otherwise provided or made available by Orchard or its Affiliates for use in the Collaboration; or (B) if such Party is Pharming, shall not be deemed to be Controlled by Pharming such Party or its Affiliates. Notwithstanding the foregoing, neither a Party or its Affiliates will be deemed to “Control” any Information, Know-How, material, Patent or other property right that is owned or controlled by an Affiliate of such Party that was not an Affiliate of such Party immediately prior to a Change of Control of such Party: (1) prior to such Change of Control, that is not generated through the use or incorporation of such Party’s or any of its Affiliates’ (who was an Affiliate of such Party prior to such Change of Control) material, Know-How or Patent Rights or through the Exploitation of the Licensed Product or (2) after such Change of Control of such Party, to the extent generated without using or incorporating any of the Orchard Background IP, Pharming Background IP, Orchard Collaboration IP, Joint Collaboration IP, Pharming Collaboration IP, Orchard Conditioning IP, Joint Conditioning IP and Pharming Conditioning IP and to the extent generated through activities that do not involve the Exploitation of the Licensed Product.
8 1.24 “Costs” means all: (a) out-of-pocket costs and expenses and (b) FTE Costs. 1.25 “Cover” means, with respect to a particular subject matter at issue and a relevant Patent, that, in the absence of ownership of or a licence under such Patent, the manufacture, use, sale, offer for sale, or importation of such subject matter would infringe one or more issued Valid Claims of such Patent, or, as to a pending claim included in such Patent, the manufacture, use, sale, offer for sale, or importation of such subject matter would infringe such Patent if such pending claim were to issue in an issued patent. 1.26 “Development” means all activities related to the clinical development of the Licensed Product conducted on or after the filing of a first IND in respect thereof, including, without limitation, testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing, and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “Develop” means to engage in Development. For purposes of clarity, Development shall include any submissions (and activities required in support thereof) required by Applicable Laws or a Regulatory Authority as a condition or in support of obtaining a pricing or reimbursement approval for an approved Licensed Product. 1.27 “Development Milestone Payments” has the meaning set forth in Section 9.3.1. 1.28 “Development Milestones” has the meaning set forth in Section 9.3.1. 1.29 “Dispute” has the meaning set forth in Section 16.8(a). 1.30 “Distributor” has the meaning set forth in Section 3.4. 1.31 “Dollars” or “$” means United States Dollars. 9 1.32 “Drug Approval Application” means (a) a New Drug Application, submitted to the FDA pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act and 21 CFR § 314.50 (“NDA”); (b) a Biologics License Application submitted to the FDA pursuant to Section 351(a) of the Public Health Service Act and the regulations promulgated thereunder (“BLA”); (c) an application for authorization to market and/or sell a biological or pharmaceutical product submitted to a Regulatory Authority in any country or jurisdiction other than the United States (“MAA”), including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the Centralized Approval Procedure; or (d) with respect to any biological or pharmaceutical product for which a NDA, BLA or MAA has been approved by the applicable Regulatory Authority, an application to supplement, amend or vary such NDA, BLA or MAA. 1.33 “Effective Date” means the effective date of this Agreement as set forth in the preamble hereto. 1.34 “Election Notice” has the meaning set forth in Section 15.6.2. 1.35 “EMA” means the European Medicines Agency and any successor agency or authority having substantially the same function. 1.36 “European Union” means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto. 1.37 “Exploit” or “Exploitation” means to make, have made, import, have imported, export, have exported, use, have used, sell, have sold, offer for sale, or have offered for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), or otherwise dispose of. 1.38 “FDA” means the United States Food and Drug Administration and any successor agency or authority having substantially the same function. 10 1.39 “Field” means any and all uses in humans, including the diagnosis, prophylaxis, treatment, palliation or cure of any human indication. 1.40 “First Commercial Sale” means, with respect to the Licensed Product and a country, the first sale for monetary value, after Regulatory Approval of such Licensed Product in that country, for use or consumption by the end user of the Licensed Product in such country. For the avoidance of doubt any so-called “treatment IND sales”, “named patient sales”, and/or “compassionate use sales” of the Licensed Product in a country following Regulatory Approval of such Licensed Product in such country shall constitute a First Commercial Sale of such Licensed Product in such country. 1.41 “FTE” means the equivalent of the work of one (1) appropriately qualified individual working on a full-time basis in performing work in connection with this Agreement for a twelve (12) month period, consisting of at least a total of [_____] hours per Year. 1.42 “FTE Costs” means the internal cost of a Party incurred in the performance of work in connection with this Agreement, being the FTEs incurred by such Party in such performance, multiplied by the FTE Rate. 1.43 “FTE Rate” means, for the period from the Effective Date to 31 December 2021, [_____] per FTE. Thereafter, the FTE Rate shall be [_____] of each Year by [_____]. 1.44 “Generic Competition” has the meaning set forth in Section 9.5.3(c). 1.45 “Generic Product” means, with respect to a particular Licensed Product (the “Reference Product”) and regulatory jurisdiction, any product that is sold by a Third Party that is not an Affiliate or Sublicensee of Pharming under a Regulatory Approval granted by a Regulatory Authority in such regulatory jurisdiction to such Third Party and (a) contains the same active ingredient (or any equivalent derivatives) of the Licensed Product, (b) its Regulatory Approval was granted through reference to the Regulatory Approval of the Reference Product, and/or (c) is approved as (i) a ‘biosimilar’ (as defined in the United States under 42 U.S.C. § 262(i)(2)) of the Reference Product, (ii) a “similar biological medicinal product” (in the EU in accordance with Directive 2001/83/EC) with respect to which the Reference Product is the “reference medicinal product,” or (iii) if not in the 11 US or EU, the foreign equivalent of a “biosimilar” or “similar biological medicinal product” of such Reference Product. 1.46 “Government Official” means (a) any Person acting on behalf of a government, government-controlled agency or entity or public international organization, (b) any political party, party official or candidate, (c) any Person who holds or performs the duties of an appointment, office or position created by custom or convention or (d) any Person who holds himself out to be the authorized intermediary of any of the foregoing. 1.47 “Governmental Authority” means any court, administrative body, local authority or other governmental or quasi-governmental entity with competent jurisdiction, any supra- national, national, federal, state, municipal, provincial or local governmental, regulatory or administrative authority, agency, commission, court tribunal, arbitral body, self- regulated entity, private body exercising any regulatory, taxing, importing or other governmental or quasi-governmental authority or other governmental entity, including any relevant Regulatory Authority. 1.48 “High Incidence Secondary Indication” means a Secondary Indication in relation to which the Licensed Product has not received orphan drug designation in the United States. 1.49 “IND” means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the United States Federal Food, Drug, and Cosmetic Act, as amended, or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (e.g., a Clinical Trial Application), and (c) all supplements, amendments, variations, extensions, and renewals thereof that may be filed with respect to the foregoing. 1.50 “IND Clearance” means, with respect to an IND, the earlier to occur of: (a) receipt by Pharming, any of its Affiliates, or any Sublicensee of written confirmation from a Regulatory Authority that Clinical Studies may commence or be conducted under such
12 IND; or (b) expiration of the applicable waiting period after which Clinical Studies may commence or be conducted under such IND. 1.51 “Indemnitee” has the meaning set forth in Section 14.3. 1.52 “Indemnitor” has the meaning set forth in Section 14.3. 1.53 “Indication” means a disease, disorder, illness, or health condition and all of its associated signs, symptoms, stages, or any progression of the foregoing (including precursor conditions), in each case, for which a separate Pivotal Study is required. 1.54 “Indirect Taxes” has the meaning set forth in Section 10.4.2. 1.55 “Information” means all knowledge of a technical, scientific, business or other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, regulatory data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre- clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, or of commercial advantage) in written, electronic, or any other form now known or hereafter developed. 1.56 “Infringement” has the meaning set forth in Section 11.3.1. 1.57 “Initiation” means, with respect to a Clinical Study, the first dosing of a Licensed Product in the first (1st) human subject in such Clinical Study. “Initiated” has a correlative meaning. 1.58 “Joint Collaboration IP” means the Joint Collaboration Patents and Joint Collaboration Know-How. 13 1.59 “Joint Collaboration Know-How” means any and all Know-How that is created, conceived or developed after the Effective Date jointly by or on behalf of Pharming or its Affiliates on the one hand, and by or on behalf of Orchard or its Affiliates on the other hand, in performing activities under this Agreement, but excluding all Platform Know- How, Orchard Collaboration Know-How, Pharming Collaboration Know-How and Joint Conditioning Know-How. 1.60 “Joint Collaboration Patents” means any and all Patents that Cover any Joint Collaboration Know-How. 1.61 “Joint Conditioning IP” means the Joint Conditioning Know-How and the Joint Conditioning Patents. 1.62 “Joint Conditioning Know-How” means any and all Know-How that is created, conceived or developed after the Effective Date jointly by or on behalf of Pharming or its Affiliates on the one hand, and by or on behalf of Orchard or its Affiliates on the other hand, in performing activities under this Agreement that relates to a Conditioning Regimen, but excluding all Platform Know-How, Orchard Collaboration Know-How, and Pharming Collaboration Know-How. 1.63 “Joint Conditioning Patents” means any and all Patents that Cover any Joint Conditioning Know-How. 1.64 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 2.1. 1.65 “Know-How” means any and all data, results, inventions, methods, processes, practices, trade secrets, techniques, technology, and other proprietary Information, whether patentable or not, but which are not generally known, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), clinical trial and patient selection designs and methodology, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions. 14 1.66 “Knowledge” means the actual knowledge of Orchard’s Chief Business Officer and General Counsel, without the requirement of conducting any specific enquiry or due diligence. 1.67 “[_____ ]Rules” has the meaning set forth in Section 16.8(b). 1.68 “Licensed Product” means any ex vivo autologous haematopoietic stem cell lentivirus- mediated gene therapy developed, whether in whole or in part, under this Agreement. 1.69 “Losses” has the meaning set forth in Section 14.1. 1.70 “Low Incidence Secondary Indication” means a Secondary Indication in relation to which the Licensed Product has received orphan drug designation in the United States. 1.71 “Manufacture” and “Manufacturing” means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labelling, shipping, and holding of any molecule, product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre- clinical, clinical and commercial production and analytic development, product characterization, supply chain, stability testing, quality assurance testing and release, and quality control and “Manufactured” and “Manufacturer” have correlative meanings. 1.72 “Manufacturing Process” means all Information pertaining to the Manufacture of the Licensed Product, including the lentiviral vector, manufacturing methods, test methods, specifications, materials, and other procedures, directions and controls associated with the Manufacture of the Licensed Product. 1.73 “Manufacturing Process Improvements” means any Patents or Know-How Controlled by Orchard or its Affiliates, that (a) constitute a modification, enhancement, development or improvement to the Manufacturing Process, (b) are created, conceived or developed independently of the performance of the Agreement at any time during the period from the Effective Date until the first Drug Approval Application in respect of the Licensed Product is submitted anywhere in the Territory, and (c) which Orchard discloses or has an obligation to disclose to Pharming pursuant to Section 2.2.7. 15 1.74 “[_____]” means [______] and its Affiliates. 1.75 “[_____] Agreements” means the agreement(s) between Orchard and [_____] under which Orchard will arrange for the Manufacture and supply of the Licensed Product from [_____] to Orchard as of the Effective Date. 1.76 “Net Sales” means, with respect to the Licensed Product for any period, the [_____] on sales of the Licensed Product during such period by Pharming, its Affiliates, or Sublicensees in the Territory to Third Parties (including to Distributors), in bona fide arm’s length transactions, less the following actually incurred deductions, in each case related specifically to the Licensed Product and not otherwise recovered by or reimbursed to Pharming, its Affiliates, or Sublicensees: (a) [_____]; (b) [_____]; (c) [_____]; (d) [_____]; and (e) [_____]. Net Sales shall not include [_____]. Net Sales shall include the amount or fair market value of [_____]. Net Sales shall not include [_____]. Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of Pharming, its Affiliates, or Sublicensees, which must be in accordance with Accounting Standards and consistent with the audited net sales reported externally by Pharming. For the purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 10.3. 1.77 “NTCR” means a [_____] that: (a) does not involve the use of [_____]; and (b) requires no more than [_____].
16 1.78 “NTCR Activities” means those activities specified in the Pre-Clinical Plan and/or the Clinical Development Plan as NTCR Activities. For the avoidance of doubt, NTCR Activities shall not include any activities that (i) are specific to the Licensed Product, or (ii) which relate to the implementation of the NTCR or any Conditioning Regimen, as opposed to its Development, improvement or enhancement. 1.79 “NTCR Activities Costs” has the meaning set forth in Section 9.2.1(b). 1.80 “NTCR Budget” means the budget for the NTCR Activities set out in the Pre-Clinical Plan and the Clinical Development Plan. 1.81 “Ongoing Clinical Studies” has the meaning set forth in Section 15.6.3. 1.82 “Orchard Background IP” means the Orchard Background Patents and Orchard Background Know-How. 1.83 “Orchard Background Know-How” means any and all Know-How Controlled by Orchard or any of its Affiliates: 1.83.1 on the Effective Date, or at any time during the period from the Effective Date until the first Drug Approval Application in respect of the Licensed Product is submitted anywhere in the Territory, which has been generated otherwise than in the performance of this Agreement, in each case, solely to the extent that such Know-How is (a) actually used by Orchard, its Affiliates or Subcontractors in the performance of its activities under this Agreement, or made available to Pharming or its Affiliates for use in the performance of their activities under this Agreement, and, in the case of any Know-How pertaining to the Manufacture of the Licensed Product, to the extent such Know-How is included in the Manufacturing Process actually used for the Manufacture of the Licensed Product, or (b) without limiting the foregoing, necessary for the performance of Pharming’s obligations under this Agreement or to Exploit any Licensed Product, or 17 1.83.2 that constitutes Know-How included in any Manufacturing Process Improvements licensed to Pharming pursuant to Section 3.7. 1.84 “Orchard Background Patents” means any and all Patents Controlled by Orchard or any of its Affiliates: 1.84.1 on the Effective Date or at any time during the period from the Effective Date until the first Drug Approval Application in respect of the Licensed Product is submitted anywhere in the Territory, which become Controlled by Orchard or its Affiliates otherwise than in the performance of this Agreement, in each case, solely to the extent that such Patents are (a) actually used by Orchard, its Affiliates or Subcontractors in the performance of its activities under this Agreement, or licensed to Pharming or its Affiliates for use in the performance of their activities under this Agreement, and, in the case of any Patents pertaining to the Manufacture of the Licensed Product, to the extent such Patents Cover the Manufacturing Process actually used for the Manufacture of the Licensed Product; or (b) without limiting the foregoing, necessary for the performance of Pharming’s obligations under this Agreement or to Exploit any Licensed Product; or 1.84.2 that constitutes Patents included in any Manufacturing Process Improvements licensed to Pharming pursuant to Section 3.7; or 1.84.3 that Cover any Orchard Background Know-How. For the avoidance of doubt, Orchard Background Patents include the Patents set forth on Schedule 1.84 which may be amended in writing from time to time. 1.85 “Orchard CMC Costs” has the meaning set forth in Section 8.1.3. 1.86 “Orchard CMO” means any Third Party contract manufacturing organization engaged by Orchard for the manufacture and supply of the Licensed Product, including the Third Party Manufacturer. As of the Effective Date and without limiting the foregoing, the Orchard CMO is expected to include [_____]. 18 1.87 “Orchard Collaboration IP” means the Orchard Collaboration Patents and Orchard Collaboration Know-How. 1.88 “Orchard Collaboration Know-How” means any and all Know-How that is created, conceived or developed after the Effective Date solely by or on behalf of Orchard or its Affiliates in performing activities under this Agreement, but excluding all Platform Know-How and Orchard Conditioning Know-How. 1.89 “Orchard Collaboration Patents” means any and all Patents Controlled by Orchard or its Affiliates after the Effective Date that Cover any Orchard Collaboration Know-How. 1.90 “Orchard Conditioning IP” means the Orchard Conditioning Patents and Orchard Conditioning Know-How. 1.91 “Orchard Conditioning Know-How” means any and all Know-How that is created, conceived or developed after the Effective Date solely by or on behalf of Orchard or its Affiliates in performing activities under this Agreement relating to a Conditioning Regimen, but excluding all Platform Know-How. 1.92 “Orchard Conditioning Patents” means any Patents that Cover any Orchard Conditioning Know-How. 1.93 “Orchard Decision Matter” has the meaning set forth in Section 2.8.2(a). 1.94 “Orchard Indemnitees” has the meaning set forth in Section 14.1. 1.95 “Orchard Platform Patents” means any and all Platform Patents that Cover any Orchard Collaboration Know-How that is created, conceived or developed solely by or on behalf of Orchard or its Affiliates. 1.96 “Orchard Pre-Clinical Research Costs” has the meaning set forth in Section 9.2.1(a). 1.97 “Patent Challenge” has the meaning set forth in Section 15.4. 1.98 “Patents” means (a) all national, regional and international patents and patent applications, including provisional patent applications and any and all rights to claim priority thereto, 19 (b) all patent applications filed either from such patents, patent applications, or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents, and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations, and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications or other patents resulting from post-grant proceedings ((a), (b), and (c)), and (e) any similar patent rights, including so-called pipeline protection or any importation, revalidation, confirmation, or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents. 1.99 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department, or agency of a government. 1.100 “Pharming Background IP” means the Pharming Background Patents and Pharming Background Know-How. 1.101 “Pharming Background Know-How” means any and all Know-How Controlled by Pharming or any of its Affiliates as of the Effective Date or during the Term that is developed or invented by or on behalf of Pharming or any of its Affiliates performing activities outside the activities performed under this Agreement. 1.102 “Pharming Background Patents” means any and all Patents Controlled by Pharming or any of its Affiliates on the Effective Date or during the Term that Cover any Pharming Background Know-How. 1.103 “Pharming COC Notification Date” has the meaning set forth in Section 16.4.
20 1.104 “Pharming Collaboration IP” means the Pharming Collaboration Patents and Pharming Collaboration Know-How. For the avoidance of doubt, the Pharming Collaboration IP excludes the Platform IP. 1.105 “Pharming Collaboration Know-How” means any and all Know-How that is created, conceived or developed after the Effective Date solely by or on behalf of Pharming or its Affiliates in performing activities under this Agreement, but excluding all Platform Know-How. 1.106 “Pharming Collaboration Patents” means any and all Patents Controlled by Pharming after the Effective Date that Cover any Pharming Collaboration Know-How. 1.107 “Pharming Competitive Acquiror” means any Person acquiring a Controlling Interest in Pharming (or a Holding Company of Pharming) or its property or business pursuant to a Change of Control of Pharming, where, as of the date of such Change of Control, such acquiring Person or any of its Affiliates either: 1.107.1 derives more than [_____] of its gross revenues from ex vivo gene therapy products, or 1.107.2 where [______] or more of the publicly disclosed products being developed by such Person or any of its Affiliates are ex-vivo haematopoietic stem cell gene therapy products. 1.108 “Pharming Conditioning IP” means the Pharming Conditioning Patents and Pharming Conditioning Know-How. 1.109 “Pharming Conditioning Know-How” means any and all Know-How that is created, conceived or developed after the Effective Date solely by or on behalf of Pharming or its Affiliates in performing activities under this Agreement relating to a Conditioning Regimen, but excluding all Platform Know-How. 1.110 “Pharming Conditioning Patents” means any Patents that Cover any Pharming Conditioning Know-How. 21 1.111 “Pharming Indemnitees” has the meaning set forth in Section 14.2. 1.112 “Phase 1 Trial” means a human clinical trial of the Licensed Product that satisfies the requirements for a Phase 1 study as defined in 21 CFR § 312.21(a) (or any amended or successor regulations), regardless of where such clinical trial is conducted. 1.113 “Phase 2 Trial” means a human clinical trial of the Licensed Product that satisfies the requirements for a Phase 2 study as defined in 21 CFR § 312.21(b) (or any amended or successor regulations), regardless of where such clinical trial is conducted. 1.114 “Phase 3 Trial” means a human clinical trial of the Licensed Product that satisfies the requirements for a Phase 3 study as defined in 21 CFR § 312.21(c) (or any amended or successor regulations), regardless of where such clinical trial is conducted. 1.115 “Phase 4 Trial” means a human Clinical Study of the Licensed Product conducted after Regulatory Approval of the Licensed Product has been obtained from an appropriate Regulatory Authority, and includes (a) trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and (b) trials conducted after Regulatory Approval due to request or requirement of a Regulatory Authority or as a condition of a previously granted Regulatory Approval, including studies conducted in response to a paediatric written request or condition of approval studies. 1.116 “Pivotal Study” means, with respect to the Licensed Product, a Clinical Study that: (a) would satisfy the requirements of a Phase 3 Trial; (b) Pharming designates as a pivotal, or registrational, Clinical Study; or (c) is otherwise designed to generate efficacy data having a nature and quality that will be sufficient to support a Drug Approval Application for the Licensed Product. For clarity, a Pivotal Study described in sub-clause (c) may be any form of Clinical Study; provided, however, that, for any Clinical Study other than a Clinical Study described in sub-clause (a), such Clinical Study shall be deemed a Pivotal Study only: (i) if the applicable Regulatory Authority agrees in writing that such Clinical Study will be deemed a pivotal trial sufficient for obtaining Regulatory Approval of the Licensed Product with no further Clinical Studies being conducted prior to the grant of such Regulatory Approval; or (ii) upon the filing of a Drug Approval Application with 22 the FDA, EMA or any Regulatory Authority in the European Union by Pharming, any of its Affiliates, or any Sublicensee for the Licensed Product based upon the results of such Clinical Study as a pivotal study, in which case, for the avoidance of doubt, such Pivotal Study shall also be deemed to have been Initiated. 1.117 “Platform” means Orchard’s proprietary gene therapy platform existing at the Effective Date and as developed outside of this Agreement, including as described in the Orchard Background IP. 1.118 “Platform IP” means the Platform Patents and Platform Know-How. 1.119 “Platform Know-How” means any and all Know-How that is created, conceived or developed after the Effective Date: (a) by or on behalf of either Party or (b) jointly by or on behalf of Pharming on the one hand, and by or on behalf of Orchard on the other hand, in each case (a) and (b), in performing activities under this Agreement, in each case to the extent such Know-How relates solely to the Platform. 1.120 “Platform Patents” means any Patents that Cover any Platform Know-How. 1.121 “PMDA” means Japan’s Pharmaceuticals and Medical Devices Agency and any successor agency or authority having substantially the same function. 1.122 “Pre-Clinical Budget” means the budget for the Pre-Clinical Plan (excluding any NTCR Activities) set out in the Pre-Clinical Plan. 1.123 “Pre-Clinical Plan” means the pre-clinical research plan attached hereto as Schedule 1.123. 1.124 “Pre-Clinical Research” means the activities carried out by or on behalf of a Party hereunder (whether on its own or jointly with the other Party) pursuant to the Pre-Clinical Plan. 1.125 “Pricing Approval” means, with respect to any country where a Governmental Authority authorizes reimbursement or access, or approves or determines pricing, for pharmaceutical or biologic products, receipt (or, if required to make such authorization, 23 approval of determination effective publication) of such reimbursement or access authorization or pricing approval or determination (as the case may be). 1.126 “Primary Indication” means the diagnosis, prophylaxis, treatment, palliation or cure of hereditary angioedema in humans. 1.127 “Product Specific Patent” means any Orchard Background Patent, Orchard Collaboration Patent, Orchard Conditioning Patent or Platform Patent that specifically and solely claims the composition of matter, manufacture, and/or method of use of the Licensed Product. Without limiting the foregoing: (a) the Product Specific Patent identified by Orchard and existing at the Effective Date is set out in Schedule 1.127; (b) Product Specific Patents include the Patent set out in Schedule 1.127, and all Patents that claim priority from or arise from such Patent, and (c) the Parties may choose to designate any other Orchard Background Patent, Orchard Collaboration Patent, Orchard Conditioning Patent or Platform Patent as a Product Specific Patent, subject to prior written agreement. 1.128 “Proof of Concept NTCR Endpoints” means the endpoints of the preclinical in vivo proof of concept NTCR study set out in the Pre-Clinical Plan, to the extent approved by the JSC for inclusion in the Pre-Clinical Plan under Section 2.2.4, and thereafter as amended by the JSC under Section 2.2.4. 1.129 “Publishing Party” has the meaning set forth in Section 12.5.3. 1.130 “Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Quarter shall commence on the last to occur of the foregoing dates during the Term and shall end on the last day of the Term. 1.131 “Reasonable Efforts” means, with respect to any activities performed by a Party under this Agreement with respect to the Licensed Product, the performance of such activities using at least the same degree of skill, quality and care, and using at least the same level of efforts and resources, that are used by such Party and its Affiliates for themselves with
24 respect to their own wholly-owned products at a similar stage of development or product life as the Licensed Product. 1.132 “Regulatory Approval” means, with respect to a country or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licences, registrations, or authorizations of any Regulatory Authority necessary to Commercialize the Licensed Product in such country or other jurisdiction, excluding Pricing Approval in such country or other jurisdiction. 1.133 “Regulatory Authority” means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of the Licensed Product in the Territory, including the FDA, EMA, and PMDA. 1.134 “Regulatory Exclusivity” means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which Pharming or its Affiliates or Sublicensees have the exclusive right to market and sell the Licensed Product in such country or other jurisdiction through a regulatory exclusivity right (e.g., new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, paediatric exclusivity, or any applicable data exclusivity). 1.135 “Royalty Patents” has the meaning set forth in Section 1.137. 1.136 “Royalty Payments” has the meaning set forth in Section 9.5.1. 1.137 “Royalty Term” means, with respect to each country in the Territory, the period beginning on the date of the First Commercial Sale of the Licensed Product in such country, and ending on the latest to occur of (a) the expiration of the last-to-expire Valid Claim of any Orchard Background Patent, Orchard Collaboration Patent, Platform Patent or Joint Collaboration Patent (provided that, in respect of Joint Collaboration Patents, its 25 earliest priority date is prior to filing of the first IND for the Licensed Product) that Covers the Licensed Product in such country (such Patents containing such Valid Claim, the “Royalty Patents”), (b) the expiration of Regulatory Exclusivity for the Licensed Product in such country, and (c) the twelfth (12th) anniversary of the First Commercial Sale of the Licensed Product in such country. 1.138 “Sales Milestone Payments” has the meaning set forth in Section 9.4.1. 1.139 “Sales Milestones” has the meaning set forth in Section 9.4.1. 1.140 “Secondary Indication” means any Indication except the Primary Indication. 1.141 “Senior Officer” means, with respect to Orchard, its Chief Executive Officer or his/her designee, and with respect to Pharming, its Chief Executive Officer or his/her designee. 1.142 “Subcontractor” means any contractor, subcontractor or other vendor to whom a Party has subcontracted any of its obligations under the Pre-Clinical Plan or the Clinical Development Plan. 1.143 “Sublicensee” means a Third Party, other than a Distributor or a Third Party to whom Pharming, its Affiliate or a Sublicensee subcontracts any activities with respect to the Development or Manufacture of the Licensed Product, to whom Pharming (or a sublicensee of Pharming) grants a sublicence to Develop, use, import, promote, offer for sale, sell, have sold, or otherwise Commercialize any Licensed Product in the Field in the Territory. 1.144 “Term” has the meaning set forth in Section 15.1. 1.145 “Territory” means worldwide. 1.146 “Third Party” means any Person other than Orchard, Pharming, or an Affiliate of Orchard or Pharming. 1.147 “Third Party Manufacturer” means the Third Party manufacturer approved by the JSC pursuant to Section 2.2.10. 26 1.148 “Valid Claim” means either: (a) a claim of a pending Patent application, which claim was filed and is being prosecuted in good faith and has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application, provided that such prosecution has not been on-going for more than [_____] years from its earliest priority date and provided further that if, thereafter, a patent containing such claim issues, then such claim shall thereafter be considered a Valid Claim in accordance with clause (b) below; or (b) a claim of any issued and unexpired Patent for which the validity, enforceability, or patentability has not been affected by any of the following: (x) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer; or (y) a holding, finding, or decision of invalidity, unenforceability, or non-patentability by a court, governmental agency, national or regional patent office, or other appropriate body that has competent jurisdiction, such holding, finding, or decision being final and unappealable or unappealed within the time allowed for appeal. 1.149 “Validation of a Drug Approval Application by the EMA” as used in Section 9.3.1 (Development Milestone Payments) means a determination by the EMA that all essential regulatory elements required for scientific assessment are included in an MAA, triggering the start of the assessment of such MAA. 1.150 “Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term. 1.151 In this Agreement: 1.151.1 all references to a particular clause or schedule shall be a reference to that clause or schedule in or to this Agreement as it may be amended from time to time pursuant to this Agreement; 1.151.2 the headings are inserted for convenience only and shall be ignored in construing this Agreement; 27 1.151.3 words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa; 1.151.4 the words “include”, “included”, and “including” are to be construed without conveying any limitation to the generality of the preceding words; 1.151.5 reference to any statute or regulation includes any modification or re- enactment of that statute or regulation; 1.151.6 any reference to notices or consent being sought or given in writing shall require the consent or notice to be signed by an appropriately authorized person and shall not include consents or notices conveyed by email; and 1.151.7 in the event of any inconsistency or conflict between this Agreement and any of the schedules attached hereto, the provision set forth in the main body of this Agreement shall prevail over the conflicting provision in the attached schedule to the extent of such conflict, unless such provision in the attached schedule is expressly stated in such schedule to prevail over such provision in the main body of this Agreement. ARTICLE 2 COLLABORATION MANAGEMENT 2.1 Joint Steering Committee. Within [_____] days after the Effective Date, or as mutually agreed to by the Parties, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”). The JSC shall consist of two (2) representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the responsibility of the JSC. From time to time, notwithstanding good faith efforts to ensure the continuity of the key personnel representing the Parties on the JSC, each Party may substitute one (1) or more of its representatives to the JSC by providing prior written confirmation (which may be by email) to the other Party, provided such substituted JSC member possesses the requisite experience and seniority to enable such person to make decisions on behalf of the Parties as provided herein. The chairperson of the JSC shall
28 be one of the representatives selected by Orchard prior to IND Clearance for the Licensed Product, and one of the representatives selected by Pharming thereafter. From time to time, the appointing Party may change the representative who will serve as chairperson on written notice to the other Party. 2.2 Specific Responsibilities of the JSC. The JSC shall provide strategic oversight of the Collaboration. In particular, the JSC shall: 2.2.1 review and discuss the outcome of all material activities performed under the Pre-Clinical Plan and/or Clinical Development Plan, and the strategy relating thereto; 2.2.2 act as a forum to exchange information between the Parties. Without limiting the foregoing, Orchard shall, through the JSC, periodically inform Pharming of any Orchard Background IP, Orchard Collaboration IP, Orchard Conditioning IP, Joint Collaboration IP, Joint Conditioning IP and Platform IP which Orchard reasonably expects to be of benefit to Pharming under the Collaboration and, in each case, to the extent not previously reported to Pharming; 2.2.3 facilitate the preparation and filing by Pharming of submissions to Regulatory Authorities in respect of the Licensed Product; 2.2.4 review and agree to any material amendment to the Pre-Clinical Plan. Without limiting the foregoing, the JSC shall review and agree on any amendment to the Pre-Clinical Plan to include or amend the endpoints of the [_____] which will determine whether or not the Development Milestone set out in row 1 of the table in Section 9.3.1 is achieved; 2.2.5 review and agree the Clinical Development Plan and any material amendments thereto; 2.2.6 review and discuss the prosecution strategy for any Joint Collaboration Patents; 29 2.2.7 review and discuss any Manufacturing requirements for the Licensed Product, including, solely prior to the submission of the first Drug Approval Application in respect of the Licensed Product anywhere in the Territory, (a) any Manufacturing Process Improvements that: (i) Orchard or any of its Affiliates has used in any other development program it is involved in, and (ii) which Orchard reasonably expects to be of benefit to Pharming under the Collaboration and (b) solely prior to the submission of the first Drug Approval Application in respect of the Licensed Product anywhere in the Territory, any Third Party intellectual property rights to the extent not already included in subclause (a) which Orchard identifies and reasonably believes will be of benefit to Pharming under the Collaboration. Orchard shall periodically disclose the foregoing to Pharming through its JSC representatives under this Section 2.2.7. In the event that any Third Party intellectual property rights are identified by Orchard pursuant to Section 2.2.7(b), the Parties shall discuss if a Party should obtain a licence to such Third Party intellectual property and, all Costs incurred by Orchard in obtaining such licence (if it is agreed that Orchard will obtain such licence), which arise under such licence, or which arise from any activities performed under this Agreement to incorporate or otherwise utilize such Third Party intellectual property rights, shall in each case be borne by Pharming unless otherwise agreed between the Parties in writing; 2.2.8 subject to Section 9.2.2, review and agree any amendment to the Pre-Clinical Budget or NTCR Budget; 2.2.9 discuss and agree a communication plan that sets out the Parties’ obligations with respect to the communications with Regulatory Authorities prior to the first filing of an IND for the Licensed Product; 2.2.10 identify and agree a drug product Third Party Manufacturer, based in the United States; 30 2.2.11 on an as-needed basis, establish subcommittees to perform specific duties of the JSC, direct each such subcommittee to perform the functions for which it is established, and oversee each subcommittee, including resolution of disputes raised to the JSC by any subcommittee; and 2.2.12 perform such other functions, and direct each subcommittee to perform such other functions, as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. 2.3 Disbandment. The JSC shall continue to exist until the first to occur of (a) the Parties mutually agreeing to disband the JSC and (b) the First Commercial Sale of the Licensed Product (unless otherwise mutually agreed in writing). Notwithstanding anything herein to the contrary, upon the first to occur of the foregoing (a) or (b), the JSC shall automatically dissolve and shall have no further rights or obligations under this Agreement, and thereafter (i) each Party shall designate, to the extent necessary, a contact person for the exchange of Information under this Agreement or such exchange of Information shall be made through the Alliance Managers, and (ii) decisions of the JSC, if any, shall be decisions as between the Parties, subject to the other terms and conditions of this Agreement. 2.4 Location of Meetings. The JSC shall meet at least [_____], or as otherwise agreed to by the Parties. JSC meetings may be held in person or by audio or video teleconference; provided that unless otherwise agreed, at least [_____] per Year shall be held in person, provided that such in-person meeting is reasonably possible. In-person meetings shall be held at locations in the United Kingdom or the Netherlands, or such other location as selected by the Parties. 2.5 Conduct of Meetings. The chairperson of the JSC shall be responsible for calling meetings on no less than [_____] Business Days’ notice, unless an urgent issue arises that requires an earlier meeting date, in which case the chairperson shall call a meeting on the first available date as mutually agreed between the Parties. Each Party shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at least [_____] Business Days in advance of the applicable 31 meeting; provided that if the input by the JSC is required urgently, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting, such consent not to be unreasonably withheld, conditioned, or delayed. Notwithstanding the foregoing, either Party may instruct the chairperson to call a meeting of the JSC on less than [_____] Business Days’ notice in the event that such Party reasonably believes that a significant matter must be addressed by the JSC within such sooner timeframe, and such Party shall provide any materials reasonably adequate to enable an informed decision to be made by the JSC at such meeting. An individual designated by the chairperson of the JSC shall prepare and circulate the minutes of each meeting for review and approval of the Parties within [_____] days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JSC. 2.6 Procedural Rules. The JSC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JSC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Representation by proxy shall be allowed. The JSC shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution which may be delivered by way of email confirmation. Employees or consultants of either Party that are not representatives of the Parties on the JSC may attend meetings of the JSC; provided that (a) unless the other Party agrees, no more than two (2) such persons, not including Alliance Managers of such Party, may attend any particular meeting, (b) attendance of any non-employee must be pre-approved by the other Party, such approval not to be unreasonably withheld, conditioned or delayed, (c) such attendees shall not vote or otherwise participate in the decision-making process of the JSC, and (d) such attendees are bound by obligations of confidentiality and non-disclosure that are substantially similar to those set forth in ARTICLE 12.
32 2.7 Clinical Development Plan. The JSC shall establish a subcommittee in accordance with Section 2.2.11, whose task it shall be to assist with the preparation of a draft Clinical Development Plan that sets out the Development activities to be performed by Pharming under this Agreement to enable Pharming to submit an initial version of the Clinical Development Plan in accordance with the subsequent sentence. Pharming shall in good faith consider any comments from the subcommittee, but shall prepare, in its sole discretion, the initial version of the Clinical Development Plan for submission to the JSC for review and approval, such submission to take place no later than the first anniversary of the Effective Date. 2.8 Decision Making. 2.8.1 JSC Decisions. All JSC decisions shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter, the JSC cannot, or does not, reach consensus on an issue within the jurisdiction of the JSC within [_____] Business Days of the matter having been first discussed by the JSC, then the dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed by the Senior Officers shall be conclusive and binding on the Parties. 2.8.2 Final Decision-Making Authority. If the Senior Officers are not able to agree on the resolution of any such issue under Section 2.8.1 within [_____] days after such issue was first referred to them, then: (a) Orchard shall have final decision-making authority with respect to any issue that relates to (i) the Pre-Clinical Research, (ii) the Manufacturing Process (including the incorporation of any Manufacturing Process Improvements) or Manufacture of the Licensed Product prior to the submission of the first Drug Approval Application in respect of the Licensed Product anywhere in the Territory, and (iii) the identity of the Third Party drug product 33 Manufacturer referenced in Section 2.2.10, for clarity, in each case (i) to (iii), that does not relate to the Clinical Development Plan or any submission to or other communications with a Regulatory Authority in respect of the Licensed Product (each, an “Orchard Decision Matter”), provided that Orchard shall not use its final decision-making authority: (a) to require Pharming to violate any Applicable Law or any agreement it, at the time of making the relevant decision, has with a Third Party; (b) to increase the total level of FTE effort or costs to be incurred by Pharming under the Pre-Clinical Plan by more than [_____] from those set out in the last version of the Pre-Clinical Budget or NTCR Budget (as applicable), including for the NTCR Activities included therein, that was approved by Pharming or, if there have not been any, the version of the Pre-Clinical Plan set out in Schedule 1.123; (c) to materially increase or decrease the obligations to be performed by Pharming under this Agreement; (d) to reallocate obligations of a Party to the other Party under the Pre-Clinical Plan; (e) to materially reduce the level of resources to be provided by Orchard to the Collaboration; (f) with respect to any matter that is reasonably determined by Pharming as materially adversely affecting the safety of the Licensed Product; or (g) with respect to any amendment to the Pre- Clinical Plan to include or amend any endpoints of the preclinical in vivo proof of concept NTCR study; and further provided that, Orchard shall not, and shall procure that its JSC representatives: (1) shall not unreasonably withhold, condition or delay its approval of any Third Party drug Manufacturer proposed by Pharming and (2) shall not withhold, condition or delay approval of the incorporation of any Manufacturing Process Improvements disclosed under Section 2.2.7 and licensed by Pharming under Section 3.7; and (b) Pharming shall have final decision-making authority with respect to: (i) from the date of the first IND filing and for the rest of the Term, 34 any issue that relates to the Clinical Development Plan, (ii) at any time during the Term, any submission to or other communications with a Regulatory Authority in respect of the Licensed Product, and (iii) the Manufacturing Process (including the incorporation of any Manufacturing Process Improvements) or Manufacture of the Licensed Product on or subsequent to the submission of the first Drug Approval Application in respect of the Licensed Product by Pharming, its Affiliates or Sublicensees to the applicable Regulatory Authority anywhere in the Territory, provided that Pharming shall not use its final decision-making authority to (a) require Orchard to violate any Applicable Law or any agreement it, at the time of making the relevant decision, has with a Third Party; (b) increase the Costs to be incurred by Orchard under the Clinical Development Plan by more than [_____] from those set out in the last version of the Clinical Development Plan or NTCR Budget (as applicable), (c) materially amend the NTCR Activities included in the Clinical Development Plan, (d) increase the amount of time to be spent by Orchard, its Affiliates or Subcontractors in performing any activities by more than [_____] from those set out in the last version of the Clinical Development Plan for (e) reallocate obligations under the Clinical Development Plan from a Party to the other Party. For clarity, prior to the date of the first IND filing, Pharming shall not have final decision-making authority with respect to any issue that relates to the Clinical Development Plan (including with respect to the initial Clinical Development Plan set out in Section 2.7), which must be agreed by the JSC on a unanimous basis provided that, Orchard shall not (and shall procure that its JSC representatives shall not) unreasonably withhold, condition or delay approval of any such issue (including with respect to the initial Clinical Development Plan submitted by Orchard under Section 2.7). 35 2.8.3 Other Disputes. For clarity, disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith that are outside of the jurisdiction of the JSC shall be resolved pursuant to Section 16.8. 2.9 Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JSC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. Subject to Sections 2.2.4, 2.2.5 and 2.2.8, the JSC does not have the power to amend, modify, or waive compliance with this Agreement; this Agreement may only be amended or modified as provided in Section 16.11, and compliance with this Agreement may only be waived as provided in Section 16.13. 2.10 Alliance Manager. Promptly after the Effective Date, each Party shall appoint a person who shall oversee contact between the Parties for all matters between meetings of the JSC and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an “Alliance Manager”). The Alliance Managers shall work together to manage and facilitate the communication between the Parties under this Agreement, including to facilitate the resolution (in accordance with the terms of this Agreement) of issues between the Parties that arise in connection with this Agreement. The Alliance Managers shall not have final decision-making authority with respect to any matter under this Agreement. If not already a member of the JSC, each Alliance Manager shall support the efforts of the JSC and shall be permitted to attend JSC meetings as appropriate as non-voting participants. Each Party may replace its Alliance Manager at any time by [_____] days’ prior notice in writing to the other Party. Each Party shall bear the costs of its Alliance Manager. 2.11 Costs. Each Party shall be responsible for all travel and related costs for its members and other representatives to attend meetings of, and otherwise participate in, the JSC.
36 ARTICLE 3 LICENCE GRANTS 3.1 Licence Grants to Pharming. Orchard hereby grants to Pharming, an exclusive (even as to Orchard and its Affiliates), royalty-bearing licence, with the right to grant sublicences as provided in Section 3.3, under the Orchard Background IP, Orchard Collaboration IP, Platform IP, Orchard Conditioning IP, and Orchard’s interest in the Joint Collaboration IP and the Joint Conditioning IP to Exploit the Licensed Product in the Field in the Territory. 3.2 Licence Grants to Orchard. Pharming hereby grants to Orchard: 3.2.1 a non-exclusive licence, with the right to grant sublicences to Affiliates and Subcontractors, under the Pharming Background IP, Pharming Collaboration IP, Pharming Conditioning IP, and Pharming’s interest in the Joint Collaboration IP and Joint Conditioning IP, solely to conduct the Pre-Clinical Research; and 3.2.2 a non-exclusive, fully paid-up licence, with the right to grant sublicences, under (a) the Pharming Collaboration IP that relates to the Platform, and (b) the Pharming Conditioning IP, in each case (a) and (b) for all uses and purposes in the Territory, except for the Exploitation of the Licensed Product in the Field. 3.3 Sublicences. Pharming shall have the right to grant sublicences, through multiple tiers of sublicences, under the licences granted in Section 3.1 to its Affiliates and Third Parties; provided that, with respect to any sublicence granted to a Sublicensee: (a) Orchard is notified that such sublicense is to be entered into and the identity of such sublicensee within [_____] Business Days of such sublicense being entered into, and (b) any such sublicences shall (i) be in writing, and (ii) be consistent with the terms and conditions of this Agreement. Pharming shall be responsible for any act or omission of any Sublicensee that constitutes a breach of this Agreement as if such Sublicensee was “Pharming” hereunder. 37 3.4 Distributorships and Promotion. Without limiting Section 3.3, Pharming and its Affiliates will have the right, in their sole discretion, to grant to any Third Party the right to import, market, distribute, promote and sell any Licensed Product in the Field, where title to the Licensed Product transfers to such Third Party and the rights granted are consistent with the scope of the licences granted to Pharming hereunder (with or without packaging and/or labelling rights); provided that, such Third Party shall only constitute a “Distributor” for the purposes of this Agreement if: (a) such grant does not include the grant of a sublicence under any Orchard Background Patent, Orchard Collaboration Patent, Platform Patent, Orchard Conditioning Patent, Joint Collaboration Patent or Joint Conditioning Patent to Develop or Manufacture Licensed Product, (b) the appointed Distributor purchases its requirements of Licensed Product from Pharming or its Affiliates but does not otherwise pay royalties, upfront payments, milestone payments or other payments to Pharming with respect to the Licensed Product, and (c) any such arrangement between Pharming or its Affiliate and such Distributor is consistent with the distribution arrangements Pharming enters into for its similar products. 3.5 Retention of Rights. Notwithstanding the exclusive licences granted to Pharming pursuant to Section 3.1, Orchard hereby expressly reserves the right (a) under the Orchard Background IP, Orchard Collaboration IP, Orchard Conditioning IP, and Orchard’s interest in the Joint Collaboration IP and Joint Conditioning IP: (i) for its internal pre- clinical research purposes; (ii) to exercise its rights and perform its obligations under this Agreement, whether directly or through one or more Affiliates or Subcontractors, including the right to perform those activities assigned to it under the Pre-Clinical Plan; and (iii) to practice, and to grant licences under, the Orchard Background IP, Orchard Conditioning IP, Orchard Collaboration IP, and Orchard’s interest in the Joint Collaboration IP and Joint Conditioning IP outside the scope of the licences granted to Pharming in Section 3.1 and outside the scope of its covenants under Section 4.1. 3.6 No Implied Licences. Except as expressly provided in this Agreement, neither Party shall acquire any licence or other intellectual property interest under or in connection with this Agreement, whether by implication, estoppel, or otherwise, under or to any Patents, 38 Know-How, Information, or other intellectual property owned or controlled by the other Party. 3.7 Manufacturing Process Improvements. Subject to the agreement of the JSC, Pharming shall have the right to include all Manufacturing Process Improvements disclosed by Orchard under Section 2.2.7(a) within the scope of the licenses under Section 3.1, such right shall be exercisable by Pharming upon written notice to Orchard on or prior to the date that is [_____] days after the JSC meeting at which Pharming are informed of such Manufacturing Process Improvements. Upon Pharming’s exercise of such right with respect to any Manufacturing Process Improvements: (i) Orchard shall use Reasonable Efforts to transfer to Pharming, and perform such activities as reasonably necessary or useful to enable Pharming to utilise, such Manufacturing Process Improvements, subject to Pharming’s reimbursement to Orchard of its Costs reasonably and actually incurred in the performance of such activities, and (ii) such Manufacturing Process Improvements shall constitute part of the Orchard Background IP and shall be licensed to Pharming under Section 3.1. 3.8 No Modifications. Notwithstanding anything to the contrary in this Agreement, Pharming shall not, directly or indirectly: (a) unless otherwise agreed by Orchard, generate analogs of or derivatives based on, modify the structure of, or reverse engineer, the retroviral vector used in the Licensed Product or (b) unless otherwise agreed by Orchard or the JSC, prior to the submission of the first Drug Approval Application in respect of the Licensed Product anywhere in the Territory, modify the drug product Manufacturing Process used in relation to the Licensed Product. 3.9 Confirmatory Patent License. Each Party shall, if requested to do so by the other, promptly enter into confirmatory licence agreements in the form or substantially the form reasonably requested by the requesting Party for purposes of recording the licences granted under this Agreement with such patent offices in the Territory as the requesting Party considers appropriate. 39 ARTICLE 4 EXCLUSIVITY 4.1 Mutual Exclusivity. During the Term, subject to Section 16.3 (Change of Control), each Party shall not, and shall ensure that its respective Affiliates do not, whether on their own or with or through a Third Party, research, Develop, Manufacture or Commercialize: (a) any ex vivo autologous haematopoietic stem cell lentivirus-mediated gene therapy product in the Primary Indication; and (b) any ex vivo autologous haematopoietic stem cell gene therapy product in the Field (excluding the Primary Indication) that uses a [_____] or a variant thereof, in each case (a) and (b), except in the performance of their respective obligations or exercise of their respective rights under this Agreement (such research, Development, Manufacture and Commercialization activities, the “Competitive Program”). ARTICLE 5 PRE-CLINICAL RESEARCH 5.1 Overview. Subject to the terms and conditions of this Agreement, the Parties will collaborate with respect to the performance of the Pre-Clinical Research and shall keep the JSC informed of such activities. 5.2 Conduct of the Pre-Clinical Plan. 5.2.1 Diligence. (a) The Parties shall use their respective Commercially Reasonable Efforts to carry out the tasks allocated to them in the Pre-Clinical Plan. Each Party shall use its Commercially Reasonable Efforts to adhere to any timeframes set forth in the Pre-Clinical Plan. (b) Each Party shall not be required to perform any activities with respect to non-clinical research for Licensed Products beyond those activities assigned to it in the Pre-Clinical Plan.
40 (c) The Parties acknowledge and agree that, notwithstanding the use of their respective Commercially Reasonable Efforts under Section 5.2.1(a), no outcome or success is or can be assured and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this Agreement. 5.2.2 Regulatory Support. Orchard shall support Pharming, solely as set out in the Pre-Clinical Plan or as otherwise agreed by the Parties in writing, to file an IND for the Licensed Product and in the activities in support thereof, including providing all documents or other materials Controlled by Orchard or any of its Affiliates as are necessary for Pharming to file an IND for the Licensed Product. 5.2.3 Updates. From time to time, but not less than [_____] (until all activities under the Pre-Clinical Plan are completed), the Parties will prepare updates and amendments, as appropriate, to the Pre-Clinical Plan (including any consequential changes to the Pre-Clinical Budget), for review of and approval by the JSC, subject to and in accordance with the applicable provisions of ARTICLE 2, including Section 2.8. 5.2.4 Order of Precedence. If the terms of the Pre-Clinical Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. 5.2.5 Subcontracting. Each Party shall have the right to subcontract its obligations under this Agreement with respect to the Pre-Clinical Plan to Subcontractors and Affiliates, subject to any limitations, restrictions or other qualifications that are set forth in the Pre-Clinical Plan; provided, that (i) any Subcontractor agrees in writing to be subject to the applicable terms and conditions of this Agreement, including the confidentiality provisions of ARTICLE 12, (ii) appropriate agreements or other measures are in place ensuring that any intellectual property rights, to the extent related to the Licensed Product that are created under this Agreement, conceived, discovered, developed, or 41 otherwise made by such Subcontractors or Affiliates will vest in, are assigned to or shall be licensed to one of the Parties in accordance with ARTICLE 11, and (iii) the subcontracting Party shall be responsible for the management of all of its Subcontractors and shall remain fully liable to the other Party for the acts and omissions of such Subcontractors. 5.2.6 Research Records. (a) Creation. Each Party shall maintain complete and accurate records (including both paper and electronic records) in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law and regulatory guidance, of all work done and results achieved in the performance of any activities under the Pre-Clinical Plan. Such records shall be retained by the applicable Party for at least [_____] years after the termination or expiration of the Agreement, or for such longer period as may be required by Applicable Law. (b) Inspection. Each Party shall have the right to reasonably inspect the other Party’s records, and shall provide copies of all requested records, to the extent reasonably required for the exercise or performance of the requesting Party’s rights under this Agreement; provided, however, that the requesting Party shall maintain such records and the Information of the other Party as Confidential Information of the other Party in accordance with ARTICLE 12 hereof and shall not use such records or Information except to the extent otherwise permitted by this Agreement. 5.2.7 Pre-Clinical Plan; Updates; Information-Sharing. (a) The initial version of the Pre-Clinical Plan is set out in Schedule 1.123. From time to time, either Party may prepare updates and amendments, as appropriate, to the Pre-Clinical Plan, for review of 42 and approval by the JSC under Section 2.8, provided that, any such update or amendment shall not be effective unless and until the JSC approves such update or amendment. (b) At least every [_____] months, through a JSC meeting, each Party shall update the JSC in respect of any then-ongoing Pre-Clinical Research activities for which such Party is responsible under the Pre-Clinical Plan. The Parties shall discuss the status, progress, and results of all such activities at such JSC meetings. ARTICLE 6 DEVELOPMENT 6.1 Overview. Subject to the terms and conditions of this Agreement, after the first IND Clearance in respect of the Licensed Product, as between the Parties, Pharming will be solely responsible for conducting all Development activities and shall keep the JSC informed of such activities. 6.2 Conduct of the Clinical Development Plan. 6.2.1 Finalisation of the Clinical Development Plan. The initial version of the Clinical Development Plan shall be prepared by Pharming and approved by the JSC pursuant to Section 2.2.5. 6.2.2 Diligence. (a) Pharming shall use its Commercially Reasonable Efforts to carry out the activities assigned to it and as set out in the Clinical Development Plan, including to use its Commercially Reasonable Efforts to adhere to any timeframes set forth in the Clinical Development Plan with respect to such activities. Orchard shall use its Commercially Reasonable Efforts to carry out any Manufacturing, supply and NTCR Activities set out in the Clinical Development Plan that are assigned to Orchard, including to use its 43 Commercially Reasonable Efforts to adhere to any timeframes set forth in the Clinical Development Plan with respect to such activities. The foregoing obligations shall no longer apply upon the the submission of the first Drug Approval Application in respect of the Licensed Product anywhere in the Territory. (b) The Parties acknowledge and agree that, notwithstanding each Party’s use of their respective Commercially Reasonable Efforts under Section 6.2.2(a), no outcome or success is or can be assured and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this Agreement. 6.2.3 Updates. From time to time, the Parties may prepare updates and amendments, as appropriate, to the Clinical Development Plan, for review of and approval by the JSC, subject to and in accordance with the applicable provisions of ARTICLE 2, including Section 2.8. 6.2.4 Order of Precedence. If the terms of the Clinical Development Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern. 6.2.5 Subcontracting. Each Party shall have the right to subcontract its obligations under this Agreement with respect to the Clinical Development Plan to Subcontractors and Affiliates, subject to any limitations, restrictions or other qualifications that are set forth in the Clinical Development Plan; provided, that (i) any Subcontractor agrees in writing to be subject to the applicable terms and conditions of this Agreement, including the confidentiality provisions of ARTICLE 12, (ii) appropriate agreements or other measures are in place ensuring that any intellectual property rights, to the extent related to the Licensed Product that are created under this Agreement, conceived, discovered, developed, or otherwise made by such Subcontractors or Affiliates will vest in, are assigned to or shall be licensed to one of the Parties in accordance with ARTICLE 11, and (iii) the subcontracting Party shall be
44 responsible for the management of all of its Subcontractors and shall remain fully liable to the other Party for the acts and omissions of such Subcontractors. 6.2.6 Research Records. (a) Creation. Pharming shall maintain complete and accurate records (including both paper and electronic records) in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law and regulatory guidance, of all work done and results achieved in the performance of any activities under the Clinical Development Plan. Such records shall be retained by Pharming for at least [_____] years after the termination or expiration of the Agreement, or for such longer period as may be required by Applicable Law. (b) Inspection. Orchard shall have the right to reasonably inspect the Pharming’s records, and shall provide copies of all requested records, to the extent reasonably required for the exercise or performance of the Orchard’s rights under this Agreement; provided, however, that Orchard shall maintain such records and the Information of Pharming as Confidential Information of Pharming in accordance with ARTICLE 12 hereof and shall not use such records or Information except to the extent otherwise permitted by this Agreement. 6.2.7 Updates; Information-Sharing. At each regularly scheduled JSC meeting, each Party shall update the JSC in respect of any then-ongoing activities for which such Party is responsible under the Clinical Development Plan. The Parties shall discuss the status, progress, and results of all such activities at such JSC meetings. In addition, Pharming shall provide a written report of its activities under the Clinical Development Plan, and the results of such activities, to Orchard each Quarter. 45 ARTICLE 7 COMMERCIALISATION 7.1 Overview. From the date of grant of the first Regulatory Approval in respect of the Licensed Product in the Field, Pharming shall be solely responsible for the Commercialization and Manufacture of the Licensed Product in the Field in the Territory. 7.2 Diligence. [_____] will use its Commercially Reasonable Efforts to seek Regulatory Approval for, and to Commercialize, the Licensed Product in the [_____]. 7.3 Reporting. Pharming shall provide to Orchard within [_____] days following the end of each Year of the Term (commencing as of the First Commercial Sale) copies of written reports containing sufficient detail to enable Orchard to assess Pharming’s compliance with Section 7.2. All such reports and the information contained therein shall constitute the Confidential Information of Pharming. ARTICLE 8 MANUFACTURING & SUPPLY; TECHNOLOGY TRANSFER AND OTHER ASSISTANCE 8.1 Orchard Manufacturing. 8.1.1 Orchard shall use its Reasonable Efforts to: (a) develop the Manufacturing Process in accordance with the Pre-Clinical Plan; (b) Manufacture and supply to Pharming sufficient quantities of the drug product for the Licensed Product for the performance of the Clinical Studies under the Clinical Development Plan, in accordance with the Clinical Development Plan; (c) transfer the Manufacturing Process in relation to the drug product to the Third Party Manufacturer’s facilities in the United States, as further set out in the Clinical Development Plan; and (d) transfer the necessary information and knowledge relating to the Manufacturing Process to Pharming, as further specified in the Clinical Development Plan. For the avoidance of doubt, Orchard shall not be required to, or to procure that any Orchard CMO or any Third Party to: (i) create any new Know-How, (ii) undertake any Manufacturing activities not 46 expressly specified in the Pre-Clinical Plan or Clinical Development Plan, or (iii) transfer any Manufacturing Process to any Third Party other than to the Third Party Manufacturer as set out in Section 8.1.1(c) above, or to Pharming as set out in Section 8.1.1(d), in each case (i) to (iii) unless otherwise agreed with Orchard in writing in advance. 8.1.2 Upon receipt of a written request by Pharming, Orchard shall facilitate Pharming to enter into a direct manufacturing and supply arrangement with the Orchard CMO, by introducing the Orchard CMO to Pharming, and by providing Orchard’s consent to allow the Orchard CMO to use any know-how developed by the Orchard CMO in relation to the Manufacture of the Licensed Product on Orchard’s behalf, for the benefit of Pharming. 8.1.3 CMC Costs. Pharming shall reimburse Orchard for all Costs incurred by Orchard in the performance of its obligations under this Section 8.1 in accordance with this Agreement to the extent such Costs do not constitute Orchard Pre-Clinical Research Costs or NTCR Activities Costs (the “Orchard CMC Costs”). Prior to entering into any agreement or arrangement with a Third Party or performing any activities which would cause Orchard to incur any Orchard CMC Costs, Orchard shall ensure that Pharming has first approved such agreement or arrangement and such Orchard CMC Costs (such approval not to be unreasonably withheld, conditioned or delayed). If Orchard has incurred any Orchard CMC Costs without first obtaining such approval from Pharming with respect thereto in accordance with this Section 8.1.3, then Pharming shall have no obligation to pay for such costs under Section 9.2.1(c). In the event that Pharming delays, conditions or refuses its consent under this Section 8.1.3, then Orchard shall not be liable for any delay or failure to perform its obligations, that arises as a result of such delay or refusal to give consent. 8.1.4 Orchard shall reasonably co-operate with Pharming to ensure the commercial infrastructure is robust and efficient, including with respect to the 47 Manufacture, supply chain and administration of the Licensed Product, provided that, if Pharming wishes to engage any Third Party resources already being used by Orchard, without limiting its other obligations under this Agreement, Orchard shall facilitate an introduction to such Third Party, but Pharming shall be required to directly contract with the selected Third Party. 8.1.5 Pharming will be solely responsible for the Manufacture of the Licensed Product for Commercialization, at its own expense. 8.1.6 Regulatory Support. (a) As between the Parties, Pharming shall, at its sole discretion, be responsible for preparing, obtaining, and maintaining INDs and other Regulatory Approvals and submissions, and conducting communications with the Regulatory Authorities, in each case, with respect to the Licensed Product, subject to Sections 5.2.2 and 8.1.6(b). Each Party shall comply with its respective obligations under any regulatory communications plan to the extent approved by the JSC under Section 2.2.8. (b) Orchard shall support Pharming, as set out in the Pre-Clinical Plan or as otherwise agreed by the Parties in writing, to file the INDs for the Licensed Product and in the activities in support thereof, including providing all documents or other materials Controlled by Orchard or any of its Affiliates as are necessary for Pharming to file the INDs for the Licensed Product. (c) If Orchard, its Affiliates or their Subcontractors (including [_____]) receives any notice or correspondence from Regulatory Authorities with respect to the Licensed Product, Orchard shall promptly (and, in any event, within [_____] Business Days of Orchard’s receipt of such notice) provide a copy thereof to Pharming, notwithstanding the foregoing Pharming agrees that any content of such notice or
48 correspondence that is not specifically related to the Licensed Product may be redacted prior to such minutes and summaries being provided to Pharming. (d) If Orchard, its Affiliates or their subcontractors (including the Orchard CMO) is requested to attend a meeting with the Regulatory Authority with respect to the Licensed Product, Orchard shall use Reasonable Efforts to procure that Pharming representatives shall be permitted to attend such meeting, and shall provide to Pharming copies of all minutes and summaries of such meeting within [_____] Business Days after Orchard’s receipt or production of such minutes or summaries, Pharming agrees that any content of such minutes and summaries that is not specifically related to the Licensed Product may be redacted prior to such minutes and summaries being provided to Pharming. ARTICLE 9 PAYMENTS AND RECORDS 9.1 Upfront Payment. 9.1.1 Within [_____] days of the Effective Date, Pharming shall pay to Orchard the non-refundable, non-creditable sum of Ten Million Dollars ($10,000,000). 9.1.2 Pharming shall purchase Seven Million Five Hundred Thousand Dollars ($7,500,000) of common shares in Orchard at the price and on the terms set out in a share purchase agreement entered into by the Parties on the Effective Date. 9.2 Pre-Clinical Research Costs; NTCR Activities Costs and CMC Costs 9.2.1 Allocations of Costs. (a) Pharming shall bear one hundred percent (100%) of all Costs that are not NTCR Activities Costs: (a) incurred by Pharming or its 49 Affiliates in the performance of its obligations under the Pre- Clinical Plan or the Clinical Development Plan; and (b) incurred by Orchard or its Affiliates in the performance of its obligations under the Pre-Clinical Plan (the “Orchard Pre-Clinical Research Costs”), subject to Section 9.2.2(a). (b) The Parties shall share equally all Costs incurred by either Party or its Affiliates in the performance of the NTCR Activities (the “NTCR Activities Costs”), subject to Section 9.2.2(b). (c) Subject to Section 8.1.3, Pharming shall bear one hundred per cent (100%) of the Orchard CMC Costs. 9.2.2 Budget Caps. (a) Pharming shall have no obligation to pay to Orchard any Orchard Pre-Clinical Research Costs with respect to any activity(ies) under the Pre-Clinical Plan to the extent exceeding [_____] of the Costs allocated to such activity(ies) under the Pre-Clinical Budget, and such excess Costs shall be deemed excluded from Orchard Pre- Clinical Research Costs, unless such excess Costs are thereafter covered by any Pre-Clinical Budget amended by the JSC. (b) Either Party shall have no obligation to share the NTCR Activities Costs incurred by the other Party or its Affiliates with respect to any NTCR Activity(ies) to the extent exceeding [_____] of the Costs allocated to be incurred by such Party for such NTCR Activity(ies) under the NTCR Budget, and such excess Costs shall be deemed excluded from the NTCR Activities Costs, unless such excess Costs are thereafter covered by any NTCR Budget amended by the JSC. (c) If either Party reasonably expects that it will incur, in the case of Orchard, Orchard Pre-Clinical Research Costs or, in the case of either Party, NTCR Activities Costs in excess of the corresponding 50 budgeted Costs in the Pre-Clinical Budget or NTCR Budget (as applicable), then subject to Sections 9.2.1(a) and 9.2.1(b), such Party shall promptly inform the JSC with respect thereto, upon which the JSC shall discuss and, if appropriate, approve any amendment of such Pre-Clinical Budget or NTCR Budget (as applicable) to cover such excess Costs under Section 2.2.8. In the event that the JSC delays, conditions or refuses its consent under Section 2.2.8 to approve any such amendment to cover such excess Costs (above [_____] of the applicable Costs set out in the Pre- Clinical Budget or NTCR Budget), then such Party shall not be liable for any delay or failure to perform its obligations under the Pre-Clinical Plan or its NTCR Activities (as applicable), to the extent caused by such delay or refusal to give consent, provided that such Party shall remain liable for such delay or failure to perform its obligations, if such actual or potential excess Costs are caused by such Party’s failure to perform its obligations under the Pre-Clinical Plan or its NTCR Activities using its Commercially Reasonable Efforts or its failure to materially comply with Applicable Laws. 9.2.3 Reports. Each Party shall report to the other Party, within [_____] days after the end of each Quarter, the Orchard Pre-Clinical Research Costs, NTCR Activities Costs, and the Orchard CMC Costs to the extent incurred by or on behalf of such Party or its Affiliates during such Quarter. Such report shall specify in reasonable detail, in a form as the Parties may mutually agree from time-to-time, all amounts included in such Costs during such Quarter. In the case of any report including Orchard Pre-Clinical Research Costs or NTCR Activities Costs, each such report shall enable the receiving Party to compare the reported Orchard Pre-Clinical Research Costs or NTCR Activities Costs against the Pre-Clinical Budget or NTCR Budget (as applicable), including to break-down the Costs incurred on a per-activity basis, and on both a Quarterly basis and a cumulative basis for each activity. The Parties shall seek to 51 resolve any questions related to such cost reports within [_____] days following receipt by each Party of the other Party’s report hereunder. 9.3 Development Milestones. 9.3.1 Development Milestone Payments. In partial consideration of the rights granted by Orchard to Pharming hereunder, Pharming shall pay to Orchard the non-refundable, non-creditable milestone payments set out below (the “Development Milestone Payments”) upon the first achievement by Pharming, its Affiliates or Sublicensees of each of the corresponding milestone events set out in the table below with respect to the Licensed Product (the “Development Milestones”). Milestone Event Milestone Payment (Primary Indication) (Dollars) Milestone Payment (Low Incidence Secondary Indications) (Dollars) Milestone Payment (High Incidence Secondary Indications) (Dollars) 1. [_____] [_____] [_____] [_____] 2. [_____] [_____] [_____] [_____] 3. [_____] [_____] [_____] [_____] 4. [_____] [_____] [_____] [_____] 5. [_____] [_____] [_____] [_____] 6. [_____] [_____] [_____] [_____] 7. [_____] [_____] [_____] [_____] 8. [_____] [_____] [_____] [_____] 9. [_____] [_____] [_____] [_____] 10. [_____] [_____] [_____] [_____] 11. [_____] [_____] [_____] [_____]
52 12. [_____] [_____] [_____] [_____] 13. [_____] [_____] [_____] [_____] Total [_____] [_____] [_____] 9.3.2 For the purposes of the table above: (a) [_____] First Commercial Sale of a Licensed Product in a country in a specific Indication will be deemed to have been occurred if such Licensed Product that is the subject of such First Commercial Sale has received Regulatory Approval by a Regulatory Authority in such country for the use of the Licensed Product in such Indication; (b) in the event that any Development Milestone is triggered in more than one Indication at the same time, then, subject to Section 9.3.5, all of the applicable Development Milestone Payments shall be paid simultaneously (if not previously paid). By way of example, if the First Commercial Sale of the Licensed Product in Japan is of a Licensed Product that has received Regulatory Approval by a Regulatory Authority in Japan for the Primary Indication and a Low Incidence Secondary Indication, but the applicable dossier did not positively reference usage of a NTCR, and, if the corresponding Development Milestone Payments have not been previously paid, such event would trigger a Development Milestone Payment of [_____]; and (c) If there is a First Commercial Sale of the Licensed Product in the applicable indication in a particular country and the dossier (i.e. SmPC or product labelling, as applicable) of such Licensed Product does not positively reference usage of a NTCR in the applicable dossier, then if such Licensed Product’s dossier is subsequently amended, updated or varied to include such positive reference, any 53 Development Milestone payable upon the First Commercial Sale of the Licensed Product in such Indication that positively references usage of a NTCR in the applicable dossier, subject to Section 9.3.5, shall be deemed achieved and become payable (if not previously paid) upon the First Commercial Sale of such Licensed Product in the relevant country after the dossier has been so amended, updated or varied, provided that such amendment, update or variation of such dossier occurs on or prior to the [_____] of the First Commercial Sale of such Licensed Product. 9.3.3 Notice and Payment. Pharming shall promptly notify Orchard in writing after the first achievement of any Development Milestone, upon which Orchard will issue an invoice to Pharming. Pharming shall ensure that each Development Milestone Payment is paid to Orchard by the later of (a) [_____] days of the first achievement of the corresponding Development Milestone and (b) [_____] Business Days from receipt of an invoice for such Development Milestone Payment from Orchard. 9.3.4 Skipped Milestones. In the event that the Development Milestone set out in row 4 in the table set out in Section 9.3.1 is first achieved without the Development Milestone set out in row 2 in such table having been achieved, the Development Milestone set out in row 2 in such table shall be deemed to be achieved at the same time and the corresponding Development Milestone Payment shall be payable at the same time. In the event that the Development Milestone set out in rows 6 is first achieved without the Development Milestone(s) set out in row 2 or row 4 in such table having been achieved, such Development Milestone(s) set out in row 2 or row 4 in such table (to the extent not previously achieved) shall be deemed to be achieved at the same time and the corresponding Development Milestone Payment(s) shall be payable at the same time. 54 9.3.5 One-time payments. Each Development Milestone in rows 1 to 7 in the table set out in Section 9.3.1 shall be able to be achieved only once and the Development Milestones in rows 8 to 13 in such table shall be able to be achieved only once in respect of each different Indication. By way of example: (a) [_____]; (b) [_____]; and (c) [_____]. 9.4 Sales-Based Milestones 9.4.1 Licensed Product Sales Milestone Payments. In partial consideration of the rights granted by Orchard to Pharming hereunder, Pharming shall pay to Orchard the following non-creditable, non-refundable milestone payments (the “Sales Milestone Payments”) upon the first achievement, as a result of the Annual Net Sales of Pharming, its Affiliates and/or Sublicensees, of each of the corresponding milestone events set out in the table below (the “Sales Milestones”) for the Licensed Product in the Field. Annual Net Sales of the Licensed Product in any and all Indications (in Dollars) Sales Milestone Payments (Dollars) [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] Total [_____] 55 9.4.2 Notice and Payment. Pharming shall notify Orchard in writing of the first achievement of any Sales Milestone in its report provided pursuant to Section 10.1. Orchard will issue an invoice to Pharming for such Sales Milestone following Orchard’s receipt of the first statement under Section 10.1 that reflects achievement of such Sales Milestone are due, which invoice shall be payable by Pharming within [_____] days of receipt. For clarity, each Sales Milestone Payment set forth in the table above shall be paid only once upon first achievement of the corresponding Sales Milestone, regardless of the number of times such Sales Milestone is achieved. 9.5 Royalties. 9.5.1 Royalty Rate. In partial consideration for the rights granted to Pharming under this Agreement, subject to the other terms of this Section 9.5, during each applicable Royalty Term, Pharming shall make [_____], non-refundable, non-creditable royalty payments to Orchard on the Net Sales of the Licensed Product sold in the Territory at the applicable royalty rate set forth below (the “Royalty Payments”): Annual worldwide Net Sales of the Licensed Product in any and all Indications Royalty Rate For that portion of Net Sales in any Year which are up to and including [_____] [_____] For that portion of Net Sales in any Year which are greater than [_____] but less than or equal to [_____] [_____] For that portion of Net Sales in any Year which are greater than [_____] but less than or equal to [_____] [_____] For that portion of Net Sales in any Year which are greater than [_____] [_____] 9.5.2 Royalty Term. Royalty Payments shall be paid on a country-by-country basis in the Territory from the First Commercial Sale of the Licensed Product in a country by or on behalf of Pharming, its Affiliates, or Sublicensees, until
56 the expiration of the Royalty Term for the Licensed Product in such country. For clarity, upon the expiry of any Royalty Term for the Licensed Product in such country, the Net Sales for such Licensed Product in such country shall not be taken into account when determining the royalty rate under the table set out in Section 9.5.1. 9.5.3 Reductions. (a) In the event that (i) Pharming enters into an agreement with a Third Party to obtain a licence or other right under any Patents owned by a Third Party with respect to the composition of matter or method of use of any Licensed Product in the Primary Indication, and for the avoidance of doubt excluding any licence or Third Party right relating to the Conditioning Regimen or Manufacturing Process, and (ii) the Licensed Product cannot be Developed or Commercialised in the Primary Indication without such licence or other Third Party right, then Pharming shall be entitled to deduct [_____] of all royalty payments paid to such Third Party pursuant to such agreement from the royalties due to Orchard pursuant to Section 9.5.1. (b) If, on a Licensed Product-by-Licensed Product basis, any Royalty Payments that are payable pursuant to Section 9.5.1 attributable to Net Sales in the United States in which there is no Valid Claim within the Orchard Background Patents, Orchard Collaboration Patents or Orchard Platform Patents Covering the composition of matter or method of use in the Field with respect to such Licensed Product, then the royalty rate otherwise applicable to the Net Sales of such Licensed Product in the United States under Section 9.5.1 will be reduced by [_____]. (c) In the event that one (1) or more Generic Products with respect to the Licensed Product are commercially available in a given country in the Territory (“Generic Competition”), in a given Quarter, then 57 Pharming shall be entitled to deduct (i) (x) in respect of all countries other than the United States [_____] and (y) in respect of the United States [_____], in each case (x) and (y) from the royalties due to Orchard under Section 9.5.1 with respect to the Licensed Product in such country, provided that Net Sales of the Licensed Product in such country in such Quarter equals between [_____] and [_____] of the average Net Sales of the Licensed Product over the four (4) consecutive Quarters immediately prior to the Quarter in which one or more Generic Products first became commercially available in such country, or (ii) [_____] from the royalties due to Orchard under Section 9.5.1 with respect to the Licensed Product in such country if Net Sales of the Licensed Product in such country in such Quarter equals less than [_____] of the average Net Sales of the Licensed Product over the four (4) consecutive Quarters immediately prior to the Quarter in which one or more Generic Products first became commercially available in such country, in each case of (i) and (ii), in such Quarter and thereafter in each Quarter during the Royalty Term in which there is Generic Competition at either such level, with respect to the Licensed Product in such country. (d) In no event will the aggregate amount of royalties due to Orchard for the Licensed Product in a country in the Territory in any given Quarter during the Royalty Term for the Licensed Product in such country be reduced by more than [_____] of the amount that otherwise would have been due and payable to Orchard in such Quarter for the Licensed Product in such country under Section 9.5.1 but for the reductions set forth in Sections 9.5.3(a), (b), and (c) above. Pharming shall have the right to carry over to subsequent Quarters any excess deduction that Pharming did not use to offset Royalty Payments due in such Quarter as a result of this Section 9.5.3(d) until the credit has been fully applied. 58 ARTICLE 10 PAYMENT; RECORDS; AUDITS 10.1 Royalty Payments and Reports. Pharming shall calculate all amounts payable to Orchard pursuant to Section 9.5 at the end of each Quarter, which amounts shall be converted to Dollars, in accordance with Section 10.3. Within [_____] days of the end of such Quarter, Pharming shall provide to Orchard a statement of (a) the amount of gross sales and Net Sales of the Licensed Product in each country in the Territory during the applicable Quarter (including such amounts expressed in local currency and as converted to Dollars), (b) the deductions applied in the calculation of Net Sales from gross sales, (c) the applicable royalty rate(s) under Section 9.5.1 (including any reduction(s) to such royalty rate(s) under Section 9.5.3), and (d) a calculation of the amount of royalty payment due on such Net Sales for such Quarter. Following the receipt of such statement for such Quarter, Orchard shall issue to Pharming an invoice of the Royalty Payments for such Quarter, which invoice shall be payable by Pharming within [_____] days of receipt. 10.2 Pre-Clinical Research, NTCR and Manufacturing Payments. Within [_____] days after the later of (a) the receipt of each report pursuant to Section 9.2.3 and (b) the resolution of any questions raised by the receiving Party of any such report with respect to such report, the applicable Party shall issue an invoice to the paying Party to achieve the allocation of Costs provided in Section 9.2.1, and the paying Party will pay such invoice within [_____] days of receipt. 10.3 Mode of Payment. All payments to either Party under this Agreement shall be made, without setoff, by deposit of Dollars in the requisite amount from an entity domiciled in the United States, the United Kingdom or the Netherlands, to such bank account as the payee Party may from time to time designate by notice to the paying Party. For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), a Party shall convert any amount expressed in a foreign currency into Dollar equivalents using the exchange rate used by such Party in its standard conversion 59 methodology consistent with Accounting Standards in the quarter when such Net Sales occurred. 10.4 Taxes. 10.4.1 Withholding Taxes. Where any sum due to be paid to either Party under this Agreement is subject to any withholding tax under Applicable Laws, the Parties shall use their reasonable efforts to take all such actions, including but not limited to executing and delivering relevant documents, as will enable them to take advantage of any applicable double taxation agreement or treaty or otherwise reduce or eliminate such withholding tax. If and to the extent the withholding tax is applicable, the payor shall remit such withholding tax to the appropriate government authority, deduct the amount paid from the amount due to payee, and secure and send to payee satisfactory evidence of the payment of such withholding tax. If any withholding taxes are refundable, creditable or otherwise recoverable, each Party will provide the other such assistance as is reasonably required to obtain a refund of the withheld taxes, obtain a credit with respect to such taxes paid, or otherwise recover such taxes. 10.4.2 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes, and other similar taxes (the “Indirect Taxes”). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. 10.4.3 Taxes Resulting from a Party’s Action. Notwithstanding the foregoing in this Section 10.4, if a Party takes any action of its own discretion (not required by Applicable Laws, the terms of this Agreement or a Regulatory Authority
60 or any other agreement between the Parties written or otherwise), including any assignment without the prior written consent of the other Party, or change of place of incorporation, or failure to comply with Applicable Laws or filing or record retention requirements, which directly results in an additional or increased amount of withholding tax with respect to payments to be made pursuant to this Agreement compared with what would have been made had such action not been taken (“Withholding Tax Action”), then such Party shall bear the amount of such withholding tax to the extent resulting from such Withholding Tax Action. For clarity, if Pharming undertakes a Withholding Tax Action, then the sum payable by Pharming (in respect of which such withholding is required to be made) shall be increased to the extent necessary to ensure that Orchard receives a sum equal to the sum which it would have received had no such Withholding Tax Action occurred after taking into account any tax credit available to the payee in respect of such withholding and provided that in no circumstances shall Pharming be liable for any withholding tax that would not have arisen had the recipient been a resident of the United Kingdom and eligible for all the benefits under an applicable Double Tax Treaty with the United Kingdom. 10.5 Financial Records. Each Party shall, and shall cause its Affiliates and Sublicensees to, keep complete and accurate financial books and records pertaining to the activities performed under the Pre-Clinical Plan, the Clinical Development Plan or the Exploitation of the Licensed Product (including, the Net Sales of the Licensed Product) in sufficient detail to calculate all amounts payable hereunder with respect thereto and to verify compliance with its obligations under this Agreement. Such books and records shall be retained by the Parties and their Affiliates until [_____] years after the end of the Year to which such books and records pertain. 10.6 Audit. At either Party’s request, the other Party shall, and shall cause its Affiliates and Sublicensees to, permit an independent public accounting firm of internationally recognized standing designated by the auditing Party and reasonably acceptable to the audited Party, at reasonable times during normal business hours and upon reasonable 61 notice, to audit the books and records maintained pursuant to Section 10.5 to ensure the accuracy of all reports and payments made hereunder. Such examinations may not be conducted more than once in any [______] month period (unless a previous audit during such [_____]-month period revealed an underpayment or overpayment with respect to such period). The accounting firm shall report to the Parties with reasons whether the reports are correct or not, and the specific details concerning any discrepancies. Except as provided below, the cost of this audit shall be borne by the auditing Party, unless the audit reveals an underpayment by the audited Party of more than [_____] from the amounts due, in which case the audited Party shall bear the cost of the audit. Unless the audited Party disputes the conclusion of such audit under Section 16.8, if such audit concludes that (x) additional amounts were owed by the audited Party, the audited Party shall pay the additional amounts within [_____] days, or (y) excess payments were made by the audited Party, the auditing Party shall reimburse such excess payments, in either case ((x) or (y)), within [_____] days after the date on which such audit is completed by the auditing Party. 10.7 Confidentiality. The receiving Party shall treat all information subject to review under this ARTICLE 10 in accordance with the confidentiality provisions of ARTICLE 12 and the Parties shall cause any independent public accounting firm appointed in accordance with Section 10.6, to enter into reasonably acceptable confidentiality agreements with the audited Party obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement. ARTICLE 11 INTELLECTUAL PROPERTY 11.1 Ownership of Intellectual Property. 11.1.1 United States Law. For purposes of establishing the Parties’ respective ownership of intellectual property conceived, discovered, developed, or otherwise made under this Agreement, inventorship of Information and inventions conceived, discovered, developed, or otherwise made under this Agreement shall be determined in accordance with Applicable Law in the 62 United States as such law exists as of the Effective Date irrespective of where such conception, discovery, development or making occurs. 11.1.2 Orchard Ownership. As between the Parties, Orchard or an Affiliate designated by Orchard shall own and retain all right, title, and interest in and to any and all Orchard Background IP, Orchard Conditioning IP, Orchard Collaboration IP and Platform IP and to the extent any right, title or interest in or to any Orchard Conditioning IP, Orchard Collaboration IP or Platform IP vests in Pharming, Pharming hereby assigns all of its right, title and interest in and to any Orchard Conditioning IP, Orchard Collaboration IP and Platform IP to Orchard. 11.1.3 Pharming Ownership. As between the Parties, Pharming or an Affiliate designated by Pharming shall own and retain all right, title, and interest in and to any and all Pharming Background IP, Pharming Conditioning IP and Pharming Collaboration IP. To the extent any right, title or interest in or to any Pharming Collaboration IP or Pharming Conditioning IP vests in Orchard, Orchard hereby assigns all of its right, title and interest in and to any Pharming Collaboration IP or Pharming Conditioning IP to Pharming. 11.1.4 Joint Ownership of Joint Collaboration IP. As between the Parties, the Parties shall each own an equal and undivided interest in any and to all Joint Collaboration IP and the Joint Conditioning IP and each Party hereby assigns into the joint names of both Parties an equal and undivided interest in and to all Joint Collaboration IP and Joint Conditioning IP. At least [_____] each Party shall disclose to the other Party in writing the development, making, conception, or reduction to practice of any Joint Collaboration IP and Joint Conditioning IP. Subject to the exclusive licences granted to the Joint Collaboration IP and Joint Conditioning IP under Section 3.1, each Party shall have the right to research and Exploit (including by way of granting licences, assignments, mortgages or otherwise, in each case, solely over its share of the Joint Collaboration IP or Joint Conditioning IP) the Joint Collaboration IP 63 and the Joint Conditioning IP without a duty of seeking consent or accounting to the other Party. 11.1.5 Assignment Obligation. Each Party shall cause all Persons who perform Pre-Clinical Research or Development activities for such Party under this Agreement to be under an obligation to assign (or, if such Party is unable to cause such Person to agree to such assignment obligation despite such Party’s using reasonable efforts to negotiate such assignment obligation, provide a licence under) their rights in any Information, Know-How and inventions resulting therefrom to such Party to the extent that the foregoing relates specifically to the Licensed Product. 11.2 Maintenance and Prosecution of Patents. 11.2.1 Orchard Patents. Orchard shall have the sole right subject to this Section 11.2.1, but not the obligation, to prepare, file, prosecute, and maintain the Orchard Background Patents, Orchard Collaboration Patents, Orchard Conditioning Patents and the Platform Patents worldwide. The cost and expense of such activities shall be borne as follows: (i) to the extent relating to any and all Product Specific Patents, by Pharming, and (ii) to the extent relating to any and all Orchard Background Patents, Orchard Collaboration Patents, Orchard Conditioning Patents and the Platform Patents which are not Product Specific Patents, by Orchard. Orchard shall keep Pharming reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance of the Orchard Background Patents, Orchard Collaboration Patents, Orchard Conditioning Patents and the Platform Patents, including any Product Specific Patents. If Orchard, during the Term, determines in its sole discretion to abandon or not maintain any of the Orchard Background Patents, Orchard Collaboration Patents, Orchard Conditioning Patents, or the Platform Patents, in the Territory, and such Orchard Background Patent, Orchard Collaboration Patent, Orchard Conditioning Patents or Platform Patent Covers any Licensed Product, then Orchard shall
64 provide Pharming with prior written notice sufficiently in advance of any abandonment to enable Pharming, at its sole discretion, to maintain such Orchard Background Patents, Orchard Collaboration Patents, Orchard Conditioning Patents or Platform Patents, as the case may be, and assume the prosecution, at its sole cost and expense, and on receipt of such notice, Orchard shall transfer such prosecution to Pharming. 11.2.2 Pharming Patents. Pharming shall have the sole right with respect to the Pharming Background Patents, and the sole right subject to this Section 11.2.2 with respect to the Pharming Conditioning Patents and the Pharming Collaboration Patents, but not the obligation, to prepare, file, prosecute, and maintain the Pharming Background Patents, Pharming Conditioning Patents and the Pharming Collaboration Patents worldwide, at Pharming’s own cost and expense. Pharming shall keep Orchard reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance of the Pharming Conditioning Patents and Pharming Collaboration Patents. If Pharming, during the Term, determines in its sole discretion to abandon or not maintain any Pharming Collaboration Patent or Pharming Conditioning Patent in the Territory, then Pharming shall provide Orchard with prior written notice sufficiently in advance of any abandonment to enable Orchard, at its sole discretion, to maintain such Pharming Collaboration Patent or Pharming Conditioning Patent, as the case may be, and assume the prosecution, at its own cost and expense, and on receipt of such notice, Pharming shall transfer such prosecution to Orchard. 11.2.3 Joint Collaboration Patents. Pharming shall have the first right, but not the obligation, to prepare, file, prosecute, and maintain the Joint Collaboration Patents and the Joint Conditioning Patents worldwide, the cost and expense of such activities shall be borne as follows: (i) to the extent relating to any and all Joint Collaboration Patents and the Joint Conditioning Patents filed on or before the first IND Clearance in respect of the Licensed Product, by Pharming, and (ii) to the extent relating to any and all Joint Collaboration 65 Patents and the Joint Conditioning Patents filed after the first IND Clearance in respect of the Licensed Product, equally between the Parties. Pharming shall keep Orchard reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance of such Joint Collaboration Patents and Joint Conditioning Patents, and shall provide Orchard with a copy of all communications to and from the patent authorities regarding such Joint Collaboration Patents and Joint Conditioning Patents, including drafts of any filings or responses to be made to such patent authorities sufficiently in advance of submitting such filings or responses so as to allow Orchard a reasonable opportunity to review and comment thereon. Pharming shall reasonably consider and incorporate Orchard’s requests and suggestions with respect to such drafts and with respect to strategies for filing and prosecuting such Joint Collaboration Patents and Joint Conditioning Patents. If Pharming, during the Term, determines in its sole discretion to abandon or not maintain any of such Joint Collaboration Patents and Joint Conditioning Patents in the Territory, then Orchard shall have the right, but not the obligation, to maintain and assume the prosecution of such Patent. Pharming shall provide Orchard with prior written notice sufficiently in advance of any abandonment to enable Orchard, at its sole discretion, to maintain such Joint Collaboration Patent or Joint Conditioning Patent and assume the prosecution, at its sole cost. Promptly upon receipt of any notice from Orchard that it wishes to maintain and assume the prosecution of such Patent in accordance with the foregoing, Pharming shall transfer such prosecution to Orchard. 11.2.4 Patent Term Extension and Supplementary Protection Certificate. The Parties shall cooperate on decisions regarding patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future, wherever applicable, for Product Specific Patents and Joint Collaboration Patents, and Joint Conditioning Patents in any country or other jurisdiction. Pharming shall have the first right, but not the obligation, to apply for any extension or supplementary protection certificate for Product Specific Patents and Joint Collaboration 66 Patents, Joint Conditioning Patents and, where Pharming elects not to make an application for any extension or supplementary protection certificate, it shall inform Orchard in sufficient time for Orchard to make such application and provide a copy of all documents and other information that Orchard may need to make such application. Each Party shall keep the other fully informed of its efforts to obtain such extension or supplementary protection certificate. Each Party shall provide prompt and reasonable assistance, as requested by the other, including by taking such action as patent holder as is required under any Applicable Law to obtain such patent extension or supplementary protection certificate. 11.3 Enforcement of Patents. 11.3.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Orchard Background Patents, the Orchard Conditioning Patents, the Orchard Collaboration Patents, the Pharming Conditioning Patents, Pharming Collaboration Patents, the Joint Conditioning Patents, the Platform Patents or Joint Collaboration Patents, including the Product Specific Patents, in any jurisdiction in the Territory of which such Party becomes aware in connection with the Exploitation of any Licensed Product or any product that competes with the Licensed Product (an “Infringement”), in each case to the extent such Infringement involves, as to the Licensed Product, a competing product in the Field (a “Competitive Infringement”). 11.3.2 Orchard Patents. Subject to Section 11.3.5, Orchard shall have the sole and exclusive right, but not the obligation, to enforce and defend worldwide under its control, at its own Cost, the Orchard Background Patents, Orchard Collaboration Patents, Orchard Conditioning Patents and Platform Patents. 11.3.3 Pharming Patents. Pharming shall have the sole right, but not the obligation, to enforce and defend worldwide under its control, and at its own Cost, the 67 Pharming Background Patents, Pharming Conditioning Patents, and Pharming Collaboration Patents. 11.3.4 Joint Collaboration Patents and Joint Conditioning Patents. Unless and until [_____] assumes the maintenance and prosecution of such Joint Collaboration Patent or Joint Conditioning Patent pursuant to Section 11.2.3, [_____] shall have the first right, but not the obligation, to enforce and defend worldwide under its control, and at its own Cost, the Joint Collaboration Patents and Joint Conditioning Patents. If [_____] does not use Reasonable Efforts to enforce or defend any such Infringement with respect to such Joint Collaboration Patents or Joint Conditioning Patents (a) within [_____] days following the first notice provided to it pursuant to this Section 11.3.4, or (b) if earlier, [_____] Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, then [_____] may enforce such Joint Collaboration Patent(s) or Joint Conditioning Patent(s) at its own Cost. 11.3.5 Product Specific Patents. [_____] shall have the first right, but not the obligation, to enforce and defend worldwide under its control, and at its own Cost, the Product Specific Patents. If [_____] does not exercise Reasonable Efforts to enforce or defend any such Infringement with respect to such Product Specific Patents (a) within [_____] days following the first notice provided to it pursuant to this Section 11.3.5, or (b) if earlier, [_____] Business Days before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, then [_____] may enforce such Product Specific Patents at its own Cost. 11.3.6 Cooperation. The Parties agree to cooperate fully in any Infringement action pursuant to this Section 11.3.6. Where a Party brings such an action, the other Party shall, where necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. Unless otherwise set forth herein, the Party entitled to bring any Infringement
68 litigation in accordance with this Section 11.3.6 shall have the right to settle such claim; provided that no Party shall have the right to settle any Infringement litigation under this Section 11.3.6 in a manner that (a) [_____], (b) [_____], or (c) [_____], in each case (a) – (c) without the express written consent of such other Party, such consent not to be unreasonably withheld, conditioned, or delayed. The Party commencing the litigation shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings. 11.3.7 Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of such litigation described in this Section 11.3.7 (whether by way of settlement or otherwise) shall be first allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such costs and expenses). Any remainder after such reimbursement is made shall be retained by the Party that has exercised its right to bring the enforcement action; provided that to the extent that any award or settlement (whether by judgment or otherwise) is paid to Pharming in respect of any of the Royalty Patents, such amounts shall be treated as Net Sales of the relevant Licensed Product in the Quarter in which such award or settlement is received solely for the purposes of calculation of Royalty Payment, but, for clarity, such amounts shall not count towards the achievement of any Sales Milestone. 11.4 Infringement Claims by Third Parties. If the Exploitation of the Licensed Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging patent infringement by [_____] (or its Affiliates or Sublicensees), [_____] shall have the first right, but not the obligation, to defend and control the defence of any such claim, suit, or proceeding at its own Cost, using counsel of its own choice; provided, however, that the provisions of Sections 11.3.2 and 11.3.5 shall govern the right of [_____] to assert a counterclaim of infringement of any Orchard 69 Background Patent, Orchard Collaboration Patent, Orchard Conditioning Patent or Platform Patent. 11.5 Invalidity or Unenforceability Defences or Actions. 11.5.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the Orchard Background Patents, Orchard Collaboration Patents, Orchard Conditioning Patents, Platform Patents, Joint Conditioning Patents or Joint Collaboration Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. 11.5.2 Orchard Patents. Except as set out in Section 11.5.5, Orchard shall have the sole right, but not the obligation, to defend and control the defence of the validity and enforceability of the Orchard Background Patents, Orchard Collaboration Patents, Orchard Conditioning Patents and Platform Patents. 11.5.3 Pharming Patents. Except as set out in Section 11.5.5, Pharming shall have the sole right, but not the obligation, to defend and control the defence of the validity and enforceability of the Pharming Background Patents, Pharming Conditioning Patents and Pharming Collaboration Patents. 11.5.4 Joint Collaboration Patents and Joint Conditioning Patents. Unless and until [_____] assumes the maintenance and prosecution of such Joint Collaboration Patent or Joint Conditioning Patent pursuant to Section 11.2.3, [_____] shall have the first right, but not the obligation, to defend and control the defence of the validity and enforceability of the Joint Collaboration Patents and Joint Conditioning Patents. [_____] may participate in any such claim, suit, or proceeding in the Territory related to such Joint Collaboration Patents or Joint Conditioning Patents with counsel of its choice at its own Cost; provided that [_____] shall retain control of the defence in such claim, suit, or proceeding. If [_____] elects not to defend or control the defence of any such Joint Collaboration Patents or Joint Conditioning Patents, in a suit 70 brought in the Territory, or otherwise fails to initiate and maintain the defence of any such claim, suit, or proceeding, then [_____] may conduct and control the defence of any such claim, suit, or proceeding, at its own Cost; provided, that [_____] shall obtain the written consent of [_____] prior to settling or compromising such defence, such consent not to be unreasonably withheld, conditioned, or delayed. To the extent that there is any claim, suit, or proceeding of any of the Joint Collaboration Patents or Joint Conditioning Patents in the Territory that is not covered by the process set forth above, then each Party shall have the right to defend and control the defence of the validity and enforceability of the Joint Collaboration Patents or Joint Conditioning Patents subject to Applicable Law. 11.5.5 Product Specific Patents. [_____] shall have the first right, but not the obligation, to defend and control the defence of the validity and enforceability of the Product Specific Patents. [_____] may participate in any such claim, suit, or proceeding in the Territory related to such Product Specific Patents with counsel of its choice at its own Cost; provided that [_____] shall retain control of the defence in such claim, suit, or proceeding. If [_____] elects not to defend or control the defence of any such Product Specific Patents, or otherwise fails to initiate and maintain the defence of any such claim, suit, or proceeding, then [_____] may conduct and control the defence of any such claim, suit, or proceeding, at its own Cost; provided that [_____] shall obtain the written consent of [_____] prior to settling or compromising such defence, such consent not to be unreasonably withheld, conditioned, or delayed. 11.5.6 Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section 11.5, including by being joined as a party plaintiff in such action or proceeding, providing access to relevant documents and other evidence, and making its employees available at reasonable business hours. In connection with any such defence or claim or counterclaim related to Section 11.5.4, the controlling Party shall keep the other Party 71 reasonably informed of any steps taken, and shall provide copies of all documents filed, in connection with such defence, claim, or counterclaim. In connection with the activities set forth in this Section 11.5, each Party shall consult with the other as to the strategy for the defence of the Joint Collaboration Patents and Joint Conditioning Patents. 11.6 UPC. 11.6.1 To the extent Pharming or its designee is maintaining and prosecuting such Patents under Section 11.2, Pharming will have the right to determine whether to opt in or opt out (and to opt in again) of the Unified Patent Court system in respect of the Pharming Background Patents, Pharming Collaboration Patents, Pharming Conditioning Patents, Joint Conditioning Patents, Product Specific Patents and Joint Collaboration Patents and if requested by Pharming, Orchard will promptly do all things reasonably necessary and execute all documents required to give effect to such decision(s), provided that Pharming will reimburse Orchard its reasonable out-of-pocket costs incurred in performing such acts. 11.6.2 To the extent Orchard or its designee is maintaining and prosecuting such Patents under Section 11.2, as between the Parties, Orchard will have the right to determine whether to opt in or opt out (and to opt in again) of the Unified Patent Court system in respect of the Orchard Background Patents, Orchard Conditioning Patents, Orchard Collaboration Patents and Platform Patents, in each case, excluding any Product Specific Patents, and if requested by Orchard, Pharming will promptly do all things reasonably necessary and execute all documents required to give effect to such decision(s), provided that Orchard will reimburse Pharming its reasonable out-of-pocket costs incurred in performing such acts.
72 ARTICLE 12 CONFIDENTIALITY AND NON-DISCLOSURE 12.1 Confidentiality Obligations. At all times during the Term and for a period of [_____] years following termination or expiration hereof in its entirety, each Party shall, and each of the foregoing shall cause its Affiliates and its and their respective officers, directors, employees, consultants, contractors, and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement. Notwithstanding the foregoing, to the extent the receiving Party can demonstrate by documentation or other competent proof, the confidentiality and non-use obligations under this Section 12.1 with respect to any Confidential Information shall not include any information that: 12.1.1 has been published by a Third Party or otherwise is or hereafter becomes part of the public domain through no fault on the part of the receiving Party; 12.1.2 have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; 12.1.3 is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; 12.1.4 that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or 12.1.5 have been independently developed by or for the receiving Party without reference to or use of the disclosing Party’s Confidential Information. Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the 73 Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party. 12.2 Permitted Disclosures. Each Party may disclose Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following instances: 12.2.1 (a) filing or prosecuting Patents as contemplated by this Agreement, (b) prosecuting or defending litigation as contemplated by this Agreement, or (c) obtaining or maintaining Regulatory Approval of the Licensed Product; 12.2.2 complying with applicable court orders or governmental regulations, including regulations promulgated by securities exchanges on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted); 12.2.3 disclosure to its and its Affiliates’ respective officers, directors, employees, auditors, consultants, contractors, and agents, in each case on a need-to-know basis in connection with the Exploitation of any Licensed Product in accordance with the terms of this Agreement, in each case under written obligations of confidentiality and non-use at least as stringent as those herein; and 12.2.4 disclosure to actual and bona fide potential investors, acquirors, licensees, sublicensees, and other financial or commercial partners for the purpose of evaluating or carrying out an actual or potential investment, acquisition, or collaboration, in each case under written obligations of confidentiality and non-use at least as stringent as those herein (provided that the foregoing obligation shall be deemed satisfied if the duration of such obligations of confidentiality and non-use is at least [_____] years and such obligations of 74 confidentiality and non-use are otherwise at least as stringent as those herein); provided that the disclosing Party redacts the financial terms and other provisions of this Agreement that are not reasonably required to be disclosed in connection with such potential investment, acquisition, or collaboration, which redaction shall be prepared in consultation with the other Party. Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 12.2.1 or 12.2.2, it will, except where impermissible, give reasonable advance notice to the other Party of such disclosure and comply with all reasonable requests of the disclosing Party with respect to maintaining confidence in such Confidential Information and in any event shall use the same diligent efforts to secure confidential treatment of such Confidential Information as such Party would use to protect its own Confidential Information, but in no event less than reasonable efforts. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential Information. Any information disclosed pursuant to this Section 12.2 shall remain Confidential Information and subject to the restrictions set forth in this Agreement, including the foregoing provisions of this ARTICLE 12. 12.3 Use of Name. Except as expressly provided in this Agreement and subject to Section 12.4, neither Party shall use the name, logo, or trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of such other Party in each instance, which approval shall not be unreasonably withheld, conditioned, or delayed. The restrictions imposed by this Section 12.3 shall not prohibit either Party from making any disclosure identifying the other Party that, in the opinion of the disclosing Party’s counsel, is required by Applicable Law; provided, that such Party shall submit the proposed disclosure identifying the other Party in writing to such other Party as far in advance as reasonably practicable (and in no event less than [_____] Business Days prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment on such disclosure. 75 12.4 Public Announcements. The Parties have agreed the press release set out as Schedule 12.4 shall be the press release announcing the transaction contemplated by this Agreement. Other than this press release, neither Party shall issue any public announcement, press release, or other public disclosure regarding this Agreement or its subject matter without the other Party’s prior written consent, except for any such disclosure that is, in the opinion of the disclosing Party’s counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted). In the event a Party is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable (and in no event less than [_____] Business Days prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon, but provided that such [_____] Business Days review period has expired, such Party shall be free to make such public disclosure. Notwithstanding anything to the contrary herein, following the initial press release announcing this Agreement, each Party shall be free to disclose, without the other Party’s prior written consent, the existence of this Agreement, the identity of the other Party, and those terms of the Agreement which have already been publicly disclosed in accordance herewith. 12.5 Publications. The Parties acknowledge that scientific publications must be strictly monitored to prevent any adverse effect from premature publication of results of the Pre- Clinical Research and Development activities hereunder. 12.5.1 By Orchard. Subject to Section 12.4, Orchard shall have the right to make any publications, presentations, or public disclosures related to the Licensed Product, or the Pre-Clinical Research or Development thereof, subject to Pharming’s prior review and approval under Section 12.5.3, such approval not to be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing, Orchard shall not require Pharming’s review or approval in the event that any such publication, presentation or public disclosure has either
76 (i) been previously approved by Pharming, or (ii) contains only information which is already in the public domain. 12.5.2 By Pharming. Subject to Section 12.4, Pharming shall have the right to make any publications, presentations, or public disclosures related to the Licensed Product, subject to Orchard’s prior review, as set out in Section 12.5.3. Notwithstanding the foregoing, Pharming shall not require Orchard’s prior review in the event that any such publication, presentation or public disclosure has either (i) been previously approved by Orchard, or (ii) contains only information which is already in the public domain. 12.5.3 Review Process. Before any paper, poster or abstract is submitted for publication or an oral presentation is made under Section 12.5.1 or Section 12.5.2, the publishing or presenting Party (the “Publishing Party”) shall deliver a then-current copy of the paper or materials for oral presentation to the non-publishing Party at least [_____] days prior to submitting the paper to a publisher or making the presentation. The non-publishing Party shall review any such paper and give its comments to such Publishing Party within [_____] days after the delivery of such paper to such other Party, and, in the case of Orchard as the Publishing Party, Pharming shall confirm whether or not it approves the publication, presentation or disclosure (such approval not to be unreasonably withheld, conditioned or delayed). The Publishing Party shall comply with the other Party’s request to delete references to the other Party’s Confidential Information in any such paper prior to submission and will withhold publication of any such paper or any presentation of same for an additional [_____] days in order to permit the Parties to obtain Patent protection if such other Party deems it necessary (in the case of Orchard as the Publishing Party, and if Pharming approves the applicable publication presentation or disclosure, the foregoing may be required by Pharming as a condition of such approval). 77 12.6 Return of Confidential Information. Upon termination of this Agreement in its entirety, each Party shall promptly return to the other Party, or delete or destroy, all records and materials in such Party’s possession or control containing Confidential Information of the other Party; provided that the other Party shall be permitted to retain one (1) copy of such Confidential Information for the sole purpose of performing any continuing obligations under this Agreement, as required by Applicable Law, or for legal archival purposes. Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by such Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Party’s standard archiving and back-up procedures, but not for any other use or purpose. ARTICLE 13 REPRESENTATIONS AND WARRANTIES 13.1 Mutual Warranties. Each Party hereby represents and warrants, as of the Effective Date, as follows: 13.1.1 Organization. It is a company duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement. 13.1.2 Authorization. The execution and delivery of this Agreement and the performance by such Party of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) such Party’s charter documents, bylaws, or other organizational documents, (b) any agreement, instrument, or contractual obligation to which such Party is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to such Party. 78 13.1.3 Binding Agreement. This Agreement is a legal, valid, and binding obligation of such Party enforceable against it in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity). 13.1.4 No Inconsistent Obligation. It is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent with the terms of this Agreement, or that would impede the diligent and complete fulfilment of its obligations hereunder. 13.1.5 No Litigation. There is no claim, demand, suit, proceeding, arbitration, inquiry, investigation or other legal action of any nature, civil, criminal, regulatory or otherwise, pending or, to its actual knowledge, threatened, against it or any of its Affiliates. 13.2 Additional Warranties by Orchard. Orchard hereby warrants to Pharming, as of the Effective Date, as follows: 13.2.1 it or its Affiliates are the sole owner of the Orchard Background IP, all of which are free and clear of any liens, charges and encumbrances, except such liens, charge and encumbrances that do not adversely affect or diminish Orchard’s ability to perform its obligations or grant any licence under this Agreement; 13.2.2 Orchard has not received any written notice of any, nor is there any ongoing claim or, to Orchard’s Knowledge, threatened claim by any Third Party (i) challenging the scope, validity or enforceability of any issued Orchard Background Patents, (ii) asserting the misuse or non-infringement of any of the Orchard Background IP, (iii) challenging Orchard’s ownership or control of any of the Orchard Background IP; or (iv) otherwise instituting any Patent Challenge; 79 13.2.3 Schedule 1.84 sets out a complete and accurate list of all Orchard Background Patents, as they exist as of the Effective Date, 13.2.4 Orchard does not own, Control, or otherwise possess any Know-How or Patent, as applicable, that is necessary in connection with the Exploitation of the Licensed Product, as the Licensed Product exists at the Effective Date, which is not, or which is not contemplated to be, licensed under this Agreement; 13.2.5 Orchard and its Affiliates have complied with all Applicable Law in all material respects, including any disclosure requirements, in connection with the filing, prosecution, and maintenance of the Orchard Background Patents in the Territory. In addition, Orchard has paid all necessary application, registration, maintenance, and renewal fees in respect of the Orchard Background Patents, and Orchard has filed all necessary documents and certificates with the relevant agencies for the purpose of maintaining the Orchard Background Patents; 13.2.6 to the Knowledge of Orchard, no Third Party has infringed, is infringing or has threatened to infringe any Orchard Background Patents or has misappropriated, is misappropriating or has threatened to misappropriate any Orchard Background Know-How; 13.2.7 to the Knowledge of Orchard, the Development, Manufacture or Commercialization of the Licensed Product does not infringe any Third Party Patents or misappropriate any Third Party Know-How. To the Knowledge of Orchard, Orchard has not (a) infringed any Patents of any Third Party, or (b) misappropriate any Know-How of any Third Party, in each case ((a) and (b)), in connection with its Development or Manufacture of any Licensed Product; 13.2.8 all material and non-public Orchard Background Know-How related to any Licensed Product has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality. To the Knowledge of Orchard,
80 no material breach of such confidentiality has been committed by any Third Party; 13.2.9 Orchard and [_____] have entered into the [_____] Agreements, which are in full force and effect, and Orchard has the right under the [_____] Agreements to order from [_____] and deliver to Pharming Licensed Products for the purposes of performing Clinical Studies, and the [_____] Agreements do not conflict with Orchard’s obligations under Section 8.1; 13.2.10 Orchard, its Affiliates and its and their respective contractors and consultants have conducted (including the generation, preparation, maintenance and retention of documentation with respect thereto) all Development and Manufacture of Licensed Products in accordance with Applicable Law in all material respects; and 13.2.11 neither Orchard nor any of its Affiliates, nor, to the Knowledge of Orchard, its subcontractors, has received written notice of any proceedings pending before or threatened by any Regulatory Authority with respect to any Licensed Product. Solely for the purposes of this Section 13.2, when interpreting the definition of “Orchard Background IP” as used in this Section 13.2, Orchard Background Know-How and Orchard Background Patents shall be construed as those Know-How or Patents (as applicable) that are contemplated to be used by Orchard, its Affiliates or Subcontractors in the performance of its activities under the Agreement as of the Effective Date, or contemplated to be provided to Pharming or its Affiliates for use in its performance of their activities under this Agreement as of the Effective Date, including those Know-How or Patents (as applicable) contemplated to be used or provided under the Pre-Clinical Plan. 13.3 Mutual Covenants. Each Party hereby covenants and agrees, in connection with the performance of its activities under this Agreement: 13.3.1 it shall not employ, contract with, or retain any person directly or indirectly to perform any of the activities under this Agreement if such person is under 81 investigation by the FDA for debarment or is presently debarred by the FDA pursuant to the Generic Drug Enforcement Act of 1992, as amended (21 U.S.C. § 301, et seq.); 13.3.2 all activities conducted by or on behalf of it under this Agreement shall be performed in accordance with Applicable Laws, and applicable established internal policies and procedures (if any), including policies and procedures pertaining to research involving laboratory animals or hazardous agents and materials, as applicable. Each Party agrees that any animals used in the performance of studies under the Pre-Clinical Plan will be handled in accordance with established guidelines for the care and use of laboratory animals; 13.3.3 in performing its obligations under the Pre-Clinical Plan or the Clinical Development Plan, ensure that it complies with the following good data management practices: (a) data is generated using sound scientific techniques and processes; (b) data is being accurately recorded in accordance with good scientific practices by persons conducting such activities; (c) data is being analyzed appropriately without bias in accordance with good scientific practices; and (d) data trails exist to demonstrate or reconstruct key decisions made during the conduct of such activities; 13.3.4 in the exercise of rights and performance of its obligations under this Agreement, such Party shall comply and shall cause its and its Affiliates’ employees and contractors to comply with all Applicable Laws and, without limiting the generality of the foregoing, it shall not perform any actions that are prohibited by local or other anti-corruption laws (collectively, “Anti- Corruption Laws”) that may be applicable to such Party. Without limiting the generality of the foregoing, neither Party shall make any payments, or offer or transfer anything of value, to any Government Official or government employee, to any political party official or candidate for political office or to 82 any other Third Party, in each case, related to the transaction in a manner that would violate Anti-Corruption Laws; and 13.3.5 if such Party is Orchard, Orchard shall not, and shall procure that its Affiliates shall not, after the Effective Date, grant to any Affiliate of Orchard or any Third Party any license or other rights that would materially reduce or limit the rights granted to Pharming under this Agreement, restrict or result in a restriction on Pharming’s ability to Exploit any Licensed Product in accordance with this Agreement, or that would limit or eliminate the ownership or control of any Know-How or Patent that would be subject to the license grant under Section 3.1 in the absence of such agreement or arrangement. 13.4 Disclaimer of Warranties. Except for the express warranties set forth herein, neither Orchard nor Pharming nor any of their respective Affiliates makes any warranties, express or implied, either in fact or by operation of law, by statute, or otherwise, and each Party specifically disclaims any other warranties, whether written or oral, express or implied, including any warranty of quality, merchantability, or fitness for a particular use or purpose, or any warranty as to the validity of any patents or the non-infringement of any intellectual property rights of Third Parties. ARTICLE 14 INDEMNITY 14.1 Indemnification of Orchard. Pharming shall indemnify Orchard, its Affiliates, and their respective directors, officers, employees, consultants, contractors and agents (collectively, the “Orchard Indemnitees”) against any and all losses, damages, liabilities, penalties and costs (including reasonable attorneys’ fees and costs) (collectively, “Losses”) in connection with any and all suits, investigations, claims, or demands of Third Parties (collectively, “Claims”) incurred by or rendered against the Orchard Indemnitees arising from or occurring as a result of: 83 14.1.1 the Exploitation of any Licensed Product by or on behalf of any Pharming Indemnitee or Sublicensee; or 14.1.2 the breach by Pharming of any warranty, representation, covenant, or agreement made by Pharming in this Agreement; or 14.1.3 the negligence, recklessness or willful misconduct of any Pharming Indemnitee or Sublicensee; excluding, in each case of Sections 14.1.1 to 14.1.3, such Losses: (a) to the extent Orchard has an indemnification obligation pursuant to Section 14.2 for such Losses, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses, or (b) to the extent resulting from any Orchard Indemnitee’s breach of this Agreement, negligence or wilful misconduct. 14.2 Indemnification of Pharming. Orchard shall indemnify Pharming, its Affiliates, and its and their respective directors, officers, employees, consultants, contractors and agents (collectively, the “Pharming Indemnitees”), against any and all Losses in connection with any and all Claims incurred by or rendered against the Pharming Indemnitees arising from or occurring as a result of: 14.2.1 the breach by Orchard of any warranty, representation, covenant, or agreement made by Orchard in this Agreement; or 14.2.2 the negligence, recklessness or willful misconduct of any Orchard Indemnitee; excluding, in each case of Section 14.2.1 and 14.2.2, such Losses: (a) for which Pharming has an indemnification obligation pursuant to Section 14.1, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses, or (b) to the extent resulting from any Pharming Indemnitee’s breach of this Agreement, negligence or wilful misconduct. 14.3 Indemnification Procedure. A Party that intends to claim indemnification under this ARTICLE 14 (the “Indemnitee”) shall promptly notify the indemnifying Party (the
84 “Indemnitor”) in writing of any Claim in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole control of the defence or settlement of such Claim. The Indemnitee may participate at its Cost in the Indemnitor’s defence of and settlement negotiations for any Claim with counsel of the Indemnitee’s own choice. The indemnity arrangement in this ARTICLE 14 shall not apply to amounts paid in settlement of any action with respect to a Claim if such settlement is effected without the consent of the Indemnitor, which consent shall not be unreasonably withheld, conditioned, or delayed. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any action with respect to a Claim shall only relieve the Indemnitor of its indemnification obligations under this ARTICLE 14 if and to the extent the Indemnitor is actually prejudiced thereby. The Indemnitee shall cooperate fully with the Indemnitor and its legal representatives in the investigation of any action with respect to a Claim covered by this indemnification. 14.4 Indirect and Consequential Losses. Except to the extent any such damages are required to be paid to a Third Party as part of a Claim for which a Party provides indemnification under this ARTICLE 14, neither Party nor any of its Affiliates shall be liable for any: (i) indirect or consequential loss, or (ii) loss of profits, loss of revenue, loss of goodwill, or business interruption, howsoever caused, whether or not direct or indirect, and whether or not reasonably foreseeable, in each case (i) and (ii) whether in contract, tort, negligence, breach of statutory duty, or otherwise in connection with or arising in any way out of the terms of this agreement or the transactions contemplated hereby or the use of the Licensed Product, even if advised of the possibility of such damage. The foregoing limitation of liability shall not operate to limit or exclude either Party’s liability for (a) death or personal injury, (b) wilful misconduct (including fraud and fraudulent misrepresentation), or (c) any other liability which, pursuant to Applicable Law, cannot be limited or excluded. 14.5 Insurance. Each Party shall have and maintain, at its sole cost, an adequate liability insurance or self-insurance program (including product liability insurance) to protect against potential liabilities and risk arising out of activities to be performed under this Agreement and any agreement related hereto and upon such terms (including coverages, 85 deductible limits and self-insured retentions) as are customary in the pharmaceutical industry generally for the activities to be conducted by such Party under this Agreement. Such liability insurance or self-insurance program shall insure against all types of liability, including liability for personal injury, physical injury or property damage, arising out of such Party’s activities hereunder. This Section 14.5 shall not create any limitation on the Parties’ liability under this Agreement. Such insurance information shall be kept in confidence in the same manner as any other Confidential Information disclosed by the Parties hereunder. ARTICLE 15 TERM AND TERMINATION 15.1 Term. This Agreement shall commence on the Effective Date and, unless earlier terminated as provided herein, shall remain in effect, on a country-by-country basis, until the expiration of the Royalty Term for the Licensed Product in such country (the “Term”). Upon the expiration of the Royalty Term for the Licensed Product in a particular country, the licences granted to Pharming under Section 3.1 for the Licensed Product in such country shall become fully-paid, royalty-free, perpetual, and remain exclusive, and shall continue solely to the limited extent that such licences grant rights to (i) Know-How that is at such time, and which remains, confidential and/or (ii) Valid Claims of any Patents licensed to Pharming under Section 3.1. For clarity, subject to ARTICLE 4, nothing in this Agreement shall restrict or limit either Party’s (or their respective Affiliates’ or sublicensees’) ability to use or practice any Know-How Controlled by Orchard or its Affiliates that subsequently comes within the public domain. 15.2 Termination by Pharming for Convenience. Pharming shall have the right to terminate this Agreement for any or no reason: (i) in the event that such termination notice is submitted prior to the first IND Clearance being received in respect of the Licensed Product, upon [_____] days’ prior written notice to Orchard and (ii) in the event that such termination notice is submitted on or after the first IND Clearance is received in respect of the Licensed Product, upon [_____] days’ prior written notice to Orchard, provided 86 that in either case (i) or (ii), such notice is not served by Pharming within the [_____] following the Effective Date. 15.3 Termination for Material Breach. Each Party shall have the right to terminate this Agreement in the event that the other Party materially breaches this Agreement, and such breach shall have continued for [_____] days (or [_____] days with respect to any payment breach) after receipt from the non-breaching Party of written notice specifying the breach and requesting its cure, provided that, in the event of a good faith dispute as to whether the other Party has materially breached this Agreement, the relevant cure period with respect thereto shall be tolled from the date of receipt from the non-breaching Party of such written notice and through the resolution to such dispute in accordance with Section 16.8, and it is understood and agreed that during the pendency of such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder, and, if the material breach in question is cured by the end of the tolled cure period (i.e. prior to resolution of such dispute in accordance with such applicable provisions), then the non-breaching Party shall no longer have a right to termination under this Section 15.3 with respect to such material breach. 15.4 Termination by Orchard for Patent Challenge. Orchard shall have the right to terminate this Agreement, upon [_____] day advance written notice to Pharming, during which [_____] day period, the Parties shall confer in good faith on the resolution of any disputed issue, in the event that Pharming or any of its Affiliates or Sublicensees directly asserts in its own name, or directs a Third Party to assert, a Patent Challenge, provided that, Orchard’s right to terminate under this Section 15.4 shall not apply if: (a) Pharming or any of its Affiliates or Sublicensees withdraws such Patent Challenge, or causes such Patent Challenge to be withdrawn, within the [_____]-day notice period, or (b) such Patent Challenge is a defense against a claim, action or proceeding asserted by or on behalf of Orchard (or any of its Affiliates) against Pharming or any of its Affiliates or Sublicensees, or otherwise in connection with an assertion of a cross-claim or a counterclaim. For purposes of this Section 15.4, “Patent Challenge” means any challenge in a legal or administrative proceeding to the patentability, validity, ownership 87 or enforceability of any of the Orchard Background Patents, Orchard Conditioning Patents, Orchard Collaboration Patents or Orchard Platform Patents (or any claim thereof), including by: (x) filing or pursuing a declaratory judgment action in which any of the Orchard Background Patents, Orchard Conditioning Patents, Orchard Collaboration Patents or Orchard Platform Patents is alleged to be invalid or unenforceable; (y) filing a request for or pursuing a re-examination of any of the Orchard Background Patents, Orchard Conditioning Patents, Orchard Collaboration Patents, Orchard Platform Patents, (other than with Orchard’s written agreement), or becoming a party to or pursuing an interference; or (z) filing or pursuing any opposition, cancellation, nullity, or other like proceedings against any of the Orchard Background Patents, Orchard Conditioning Patents, Orchard Collaboration Patents or Orchard Platform Patents. 15.5 Termination for Insolvency. In the event that a Party (a) files or resolves to file for protection under (i) bankruptcy, (ii) insolvency, (iii) reorganization (save in the case of a solvent reorganization), (iv) restructuring (save in the case of a solvent restructuring), or (v) business rescue laws applicable to that Party in any jurisdiction; (b) makes an assignment for the benefit of creditors; (c) appoints or suffers appointment of a receiver, administrative receiver, bailiff or trustee or analogous appointment over substantially all of its property; (d) proposes or implements a scheme of arrangement, company voluntary arrangement or other agreement of composition, compromise or extension of its debts (other than in circumstances where such scheme, arrangement or agreement would have no adverse impact on the rights of any other Party to this Agreement); (e) proposes or is a party to any dissolution or liquidation or ceases continuation of substantially all of its business; (f) is subject to any filing of an application or a petition under any (i) bankruptcy, (ii) insolvency, (iii) reorganization (save in the case of a solvent reorganization), (iv) restructuring (save in the case of a solvent restructuring), or (v) business rescue laws or has any such application or petition filed against it that, in any such case, is not discharged within [_____] days of the filing thereof; or (g) admits in writing its inability generally to meet its obligations as they fall due in the general course (providing always that a request for fulfilment of a specific obligation to be postponed for a specified time shall not amount to an admission that the Party is generally unable to
88 meet its obligations as they fall due), then the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party. 15.6 Effects of Termination. 15.6.1 Licence Termination. Upon any termination of this Agreement, all rights and licences granted under Section 3.1 shall terminate and be of no further force or effect. For the avoidance of doubt, the licence granted under Section 3.2.2 shall survive termination of this Agreement. 15.6.2 Additional Remedies of Pharming in Lieu of Termination of Agreement by Pharming for Orchard’s Breach. In the event that it is finally determined under Section 16.8 that Pharming has the right to terminate this Agreement under Section 15.3 (for clarity, subject to the provisions of Section 15.3 with respect to cure and tolling), and if such determination occurs prior to the later of: (i) the successful completion of the technology transfer activities under Sections 8.1.1(c) and (d); and (ii) the date when the first Drug Approval Application in respect of the Licensed Product is submitted by Pharming, its Affiliates or Sublicensees to the applicable Regulatory Authority anywhere in the Territory, then, provided that the arbitrator has determined under Section 16.8, in writing, that the remedy set out in this Section 15.6.2 would be a reasonable and proportionate remedy, then Pharming shall have the right to elect, by providing written notice to Orchard referencing this Section 15.6.2 not later than [_____] days from such determination under Section 16.8 (the “Election Notice”), as Pharming’s sole and exclusive remedy with respect to such material breach by Orchard, to have this Agreement continue in full force and effect, and to have the following to apply: (a) Pharming’s obligations to pay Development Milestone Payments, Sales Milestone Payments and Royalty Payments shall be reduced to [_____] of the amount that would otherwise have been payable under this Agreement; 89 (b) Orchard shall, subject to the requirements of Applicable Law, including any regulatory or ethical requirements, and the orderly completion and wind-down of all work in progress, promptly cease performing any further activities under the Pre-Clinical Plan or Clinical Development Plan and the JSC shall be disbanded; and (c) to the extent the Manufacturing Process has not already been successfully transferred to Pharming, Orchard shall, at its Cost, use Reasonable Efforts to transfer such Manufacturing Process to Pharming, and, to the extent a technology transfer plan has been agreed pursuant to the subsequent sentence, in accordance with any technology transfer plan agreed between the Parties. The Parties will promptly agree, in good faith, a technology transfer plan, which will include the transfer of all information and documents necessary to allow Pharming to assume and carry out the terminated activities previously ascribed to be performed by Orchard under the Pre- Clinical Plan and Clinical Development Plan. Notwithstanding the foregoing, Orchard shall not be required to provide support or assistance or to perform any activities under this Section 15.6.2(c) after the expiry of [_____] months from the date of receipt by Orchard of the notice sent by Pharming under this Section 15.6.2, and for clarity: (1) Pharming’s rights under this Section 15.6.2 shall only apply if the material breach by Orchard of this Agreement has not been cured within the applicable cure period under Section 15.3; and (2) if Pharming has not provided any Election Notice within [_____] days after such final determination, Pharming shall continue to have the right to terminate this Agreement under Section 15.3 or to have the Agreement continue in full force and effect, and, in addition, to pursue any other rights or remedies available to Pharming. 90 15.6.3 Development Wind-Down or Transition. (a) Clinical Studies. Pharming shall, in its discretion, on written notice to Orchard, either (i) wind down all Clinical Studies that were Initiated by or on behalf of it prior to the termination of this Agreement (“Ongoing Clinical Studies”), or (ii) be responsible for completing (in accordance with the established protocols) all Ongoing Clinical Studies; provided, that if requested by Orchard in writing, Pharming shall transition such Ongoing Clinical Studies to Orchard. Pharming shall not commence any Clinical Studies with respect to any Licensed Product at any time after it has given or received a notice of termination pursuant to this ARTICLE 15. (b) Cooperation. (i) In the event that Orchard requests to assume responsibility for any of the Ongoing Clinical Studies, Pharming shall provide reasonable cooperation to Orchard and its designee(s) to facilitate, and the Parties shall use reasonable efforts to effect, a reasonable, orderly, and prompt transition of the Ongoing Clinical Studies and other Development activities relating to the Licensed Product to Orchard and/or its designee(s) following delivery of notice of termination so that Orchard is able to assume responsibility for the same as of the effective date of termination (unless such termination is disputed by either Party). Where the same cannot be fully achieved prior to the effective date of termination, Pharming shall continue to provide such reasonable cooperation to Orchard and its designee(s) until such transition has been completed. Without limiting the generality of the foregoing, in the event of such termination of this Agreement, Pharming shall provide reasonable consultation and assistance after 91 termination, for the purpose of transferring or transitioning to Orchard, Pharming Background Know-How and Pharming Collaboration Know-How not already in Orchard’s possession in each case, to the extent reasonably necessary or useful for Orchard to continue the Ongoing Clinical Studies of the Licensed Product. (ii) In the event this Agreement is terminated by Pharming for convenience pursuant to Section 15.2, by Orchard for Pharming’s breach pursuant to Section 15.3, by Orchard in the event of a Patent Challenge pursuant to Section 15.4, or by Orchard in the event of Pharming’s insolvency pursuant to Section 15.5, Pharming shall bear all reasonable Costs incurred by either Party in the disposition of Ongoing Clinical Studies as set forth in this Section 15.6.3. (iii) In the event this Agreement is terminated by Pharming for Orchard’s breach pursuant to Section 15.3, or by Pharming in the event of Orchard’s insolvency pursuant to Section 15.5 then Orchard shall bear all reasonable Costs of the activities performed by either Party under this Section 15.6. (iv) In the event Orchard has requested to assume responsibility for such Ongoing Clinical Studies, then at the request of Orchard, as soon as reasonably practicable thereafter the Parties shall in good faith negotiate a Transitional Assistance Agreement, setting out in further detail, the terms on which Orchard shall assume such responsibility including, if applicable, details of the assistance set out in Section 15.6.3(b)(i) to be provided. The aim of such agreement shall be to ensure that Orchard is able to assume responsibility for any Ongoing Clinical Studies and any other Development
92 activities relating to the Licensed Product as promptly and efficiently as possible, to ensure that all necessary regulatory filing(s) or submission(s) are maintained and filed for in good time and that Orchard has access to all documents, records, information, and correspondence reasonably required in connection therewith. 15.6.4 Purchase of Inventory. In the event this Agreement is terminated by Pharming for convenience pursuant to Section 15.2 or by Orchard for Pharming’s breach pursuant to Section 15.3, Orchard shall have the right, at its discretion, to purchase from Pharming any or all of the inventory of the Licensed Product, and inventory of all plasmids and vectors relevant to the manufacture of Licensed Product, held by or on behalf of Pharming at the date of termination at a price equal to Pharming’s Manufacturing cost with no mark-up; provided that Pharming shall be able to retain a sufficient amount of inventory to complete the termination of its Development or Commercialization activities. Orchard shall notify Pharming within [_____] days of the effective date of termination whether Orchard elects to exercise such right. 15.6.5 Contract Transfer. In the event this Agreement is terminated by Pharming for convenience pursuant to Section 15.2, by Orchard for Pharming’s breach pursuant to Section 15.3, by Orchard in the event of a Patent Challenge pursuant to Section 15.4, or by Orchard in the event of Pharming’s insolvency pursuant to Section 15.5, at Orchard’s request, Pharming shall use Commercially Reasonable Efforts to assign to Orchard or its designee all then-existing commercial agreements entered into between Pharming and a Third Party relating to the Licensed Products (or, in the case of such commercial agreements that relate to the Licensed Products and other product being Developed or Commercialized by or on behalf of Pharming, the rights and obligations under such commercial agreements solely with respect to the 93 Licensed Product) to the extent reasonably necessary for Orchard to continue the Development and/or Commercialization of the Licensed Product. 15.6.6 Exclusivity. For clarity, upon termination of this Agreement, each Party’s obligations under ARTICLE 4 shall terminate. 15.6.7 Licenses and Patent Prosecution. Upon any termination of this Agreement, Orchard hereby grants to Pharming a non-exclusive, sublicensable right under the Orchard Background IP, Orchard Collaboration IP, Orchard Conditioning IP, Platform IP and Orchard’s interest in the Joint Collaboration IP and the Joint Conditioning IP solely for the purposes of performing Pharming’s remaining obligations under this Agreement and completing any Ongoing Clinical Studies. For clarity, upon termination of this Agreement, Pharming’s rights in respect of the prosecution and enforcement of any Orchard Background Patents, Orchard Conditioning Patents, Orchard Collaboration Patents, Platform Patents and Product Specific Patents shall terminate. 15.6.8 Confidential Information. Upon termination of this Agreement, each Party shall return or cause to be returned to the other Party all Confidential Information of the other Party as provided in Section 12.6. 15.6.9 Remedies. Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. 15.6.10 Negotiation for IP Licence. Upon termination of this Agreement by Orchard pursuant to Section 15.3, 15.4, or 15.5, or by Pharming pursuant to Section 15.2, at Orchard’s request, Pharming hereby grants to Orchard a licence in the Field under any Patents and Know-How Controlled by Pharming as of the effective date of such termination, on substantially the terms of this Agreement save as to the diligence obligations, to the extent necessary to Exploit the Licensed Product and shall include a royalty of up to [_____] on the applicable Net Sales (each reference to “Pharming, its Affiliates, or 94 Sublicensees” in such definition shall be construed as “Orchard, its Affiliates or their sublicensees” for the purposes of the definition of Net Sales in this Section 15.6.10) of the Licensed Product but shall otherwise be fully paid-up. In the event that the Parties cannot agree the appropriate royalty rate or any other terms of such licence, the royalty rate and/or other terms shall be determined by the dispute resolution processes set out in Section 16.8. 15.6.11 Accrued Rights; Surviving Obligations. Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, the following Articles and Sections shall survive any such termination or expiration: [_____]. ARTICLE 16 MISCELLANEOUS 16.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, pandemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts, or other labour disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any Governmental Authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement). The non-performing Party shall notify the other Party of such force majeure within [_____] days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. The suspension of 95 performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use Reasonable Efforts to remedy its inability to perform. 16.2 Export Control. Neither Party shall export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export licence or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law. 16.3 Change of Control. 16.3.1 If either Party undergoes a Change of Control with a Third Party, and immediately prior to such Change of Control that Party or its Affiliates is performing any Competitive Program: (a) such Party (or its successor) shall provide the other Party with written notice of such Change of Control, within [_____] Business Days following the earlier of the first public announcement of the execution of any agreement with respect to such transaction and the closing date of such transaction; and (b) such Party will not be in breach of the restrictions set forth in Section 4.1 due to such Change of Control with such a Third Party, and such Third Party (or such Affiliate) may continue to perform, or commence the performance of, the applicable Competitive Program, so long as such Party (or its successor) does one of the following: (a) as soon as is practicable following the Change of Control of such Party or initiation of such Competitive Program, establish and implement appropriate firewall procedures to segregate the Competitive Program (and the personnel conducting such activities) from the activities performed by or on behalf of such Party pursuant to this Agreement, including ensuring that personnel directly involved in working in such Competitive Program shall not have access to any Confidential Information of either Party with respect to activities under this Agreement, provided that such firewall
96 procedures and obligation to segregate shall not extend to any accounts, financial or administrative personnel and that the directors of the applicable Third Party may receive general updates on progress and all financial information with respect to both the Competitive Program and the activities performed under this Agreement; or (b) divest, or cause its relevant Affiliates to divest, whether by sale, assignment, exclusive license or otherwise, its interest in such Competitive Program within [_____] months following such Change of Control. Where a Party implements firewalls pursuant to Section 16.3.1(a), such Party (or its successor) shall provide the other Party with a reasonably detailed written description of the applicable firewall procedures as soon as reasonably practicable following the consummation of such Party’s Change of Control and the other Party shall have the opportunity to comment on such firewall procedures, which comments such Party shall consider in good faith for incorporation into such procedures. For clarity, if the Party undergoing such Change of Control is Pharming, and such Change of Control of Pharming is by any Pharming Competitive Acquiror and such Pharming Competitive Acquiror has any Additional Competitive Program, the provisions of Section 16.4 shall also apply in respect of such Additional Competitive Program. 16.4 Pharming (or its successor) shall provide Orchard with written notice of any Change of Control of Pharming by any Pharming Competitive Acquiror that has any Additional Competitive Program(s) immediately prior to such Change of Control within [_____] Business Days following the earlier of the first public announcement of the execution of any agreement with respect to such transaction and the closing date of such transaction (the “Pharming COC Notification Date”). In the event of a Pharming Change of 97 Control, if the Pharming Competitive Acquiror has or initiates any Additional Competitive Program(s): (a) Pharming (or its successor) will do at least one of the following with respect to each such Additional Competitive Program: (i) as soon as is practicable following the Change of Control of Pharming or initiation of the Additional Competitive Program, establish and implement appropriate firewall procedures to segregate all activities (and the personnel conducting such activities) in such Additional Competitive Program from the activities performed by or on behalf of Pharming pursuant to this Agreement, including ensuring that personnel involved in working in such Competitive Program shall not have access to any Confidential Information of either Party with respect to activities under this Agreement; or (ii) divest, or cause its relevant Affiliates to divest, whether by sale, assignment, exclusive license or otherwise, its interest in such Additional Competitive Program within [_____] months following such Change of Control of Pharming. (b) Where Pharming implements firewalls pursuant to Section 16.4(a)(i), Pharming (or its successor) shall provide Orchard with a reasonably detailed written description of the applicable firewall procedures as soon as reasonably practicable following the consummation of such Pharming Change of Control and Orchard shall have the opportunity to comment on such firewall procedures, which comments Pharming shall consider in good faith for incorporation into such procedures. 98 (c) Following the Pharming Change of Control, Orchard shall have the right to limit the information or reports otherwise required to be provided to Pharming or the JSC hereunder to only that which is essential to ensure Pharming’s compliance with its obligations hereunder and Orchard shall have the right to refrain from including in such information or reports commercially sensitive information of Orchard (as Orchard may determine in its sole discretion). For clarity, following any change of control (including any change in ownership) of either Party, such Party shall continue to perform its obligations under this Agreement in accordance with the terms of this Agreement. 16.5 Assignment. Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld, conditioned, or delayed); provided, however, that either Party may assign or otherwise transfer this Agreement and its rights and obligations hereunder without the other Party’s consent to an Affiliate, provided that if the Person to which this Agreement is assigned ceases to be an Affiliate of the assigning Party, the Agreement shall be automatically assigned back to the assigning Party or its successor. In addition, either Party shall have the right to assign its rights and obligations under this Agreement to an acquiror of all or substantially all of its assets to which this Agreement relates. The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties, and the name of a Party appearing herein will be deemed to include the name of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Section 16.5. Any assignment not in accordance with this Section 16.5 shall be null and void. 16.6 Severability. If, for any reason, any part of this Agreement is adjudicated invalid, unenforceable, or illegal by a court of competent jurisdiction, such adjudication shall not, to the extent feasible, affect or impair, in whole or in part, the validity, enforceability, or legality of any remaining portions of this Agreement. All remaining portions shall 99 remain in full force and effect as if the original Agreement had been executed without the invalidated, unenforceable, or illegal part. In such event, the Parties shall negotiate promptly to replace such invalid, unenforceable, or illegal part with a valid, enforceable, and legal provision which most closely effectuates the Parties’ original intent. 16.7 Governing Law. This Agreement or the performance, breach, or termination hereof shall be interpreted, governed by, and construed in accordance with the laws of [_____], excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction; provided, that all questions concerning (a) inventorship of Patents under this Agreement shall be determined in accordance with Section 11.1.1 and (b) the construction or effect of Patents shall be determined in accordance with the laws of the country or other jurisdiction in which the particular Patent has been filed or granted, as the case may be. The parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods. 16.8 Dispute Resolution. (a) Except for disputes resolved by the procedures set forth in Section 2.8.2, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a “Dispute”), it shall be resolved pursuant to this Section 16.8. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resolution of any such issue within [_____] days (or such other period of time as mutually agreed by the Senior Officers) after such issue was first referred to them, then, if a Party wishes to pursue further resolution of such Dispute, such Dispute shall be resolved in accordance with Section 16.8(b);
100 (b) Subject to Section 16.8(a), any Dispute shall be referred to and finally resolved by arbitration administered by the [_____] under the [_____] (the “[_____] Rules”) by a sole arbitrator who shall be appointed in accordance with the [_____] Rules. The legal seat of the arbitration shall be [_____]. The arbitration shall be conducted in the English language. The award issued by the arbitrator shall be final and binding upon the Parties to the Dispute and shall not be subject to appeal. The parties to this Agreement agree that a judgment recognizing and enforcing the award may be entered in any court with jurisdiction, and irrevocably submit to the jurisdiction of any such court over the parties or their assets for purposes of recognizing and enforcing the award. The Parties hereby agree that the arbitration agreement set out in this Section 16.8(b) shall be governed by the laws of [_____]. 16.9 Interim Relief. Notwithstanding anything herein to the contrary, nothing in Section 16.8 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction, or other interim equitable relief concerning a Dispute, if necessary to protect the interests of such Party. This Section shall be specifically enforceable. 16.10 Notices. Any notice or other communication required under this Agreement shall be in writing, shall refer specifically to this Agreement, and shall be deemed given only if (a) delivered by hand or (b) sent by internationally recognized overnight delivery service addressed to the Parties at their respective addresses specified below or to such other address as a Party may specify in accordance with this Section 16.10. Such notice shall be deemed to have been given as of the date delivered by hand or on the second (2nd) Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 16.10 is not intended to govern the day-to-day 101 business communications necessary between the Parties in performing their obligations under the terms of this Agreement. 102 If to Pharming, to: Pharming Technologies B.V. Darwinweg 24, Leiden 2333 CR, The Netherlands Attn: Legal Department, With a copy to: Pharming Healthcare, Inc. 10 Independence Blvd, Warren, New Jersey 07059 Attn: Legal Department If to Orchard, to: Orchard Therapeutics (Europe) Limited 108 Cannon Street London EC4N 6EU Attention: Legal Department [_____] With a copy to: (i) Orchard Therapeutics (Europe) Limited 108 Cannon Street London EC4N 6EU Attention: Business Development Department and (ii) [_____] 16.11 Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral, with respect thereto are 103 superseded hereby (including that certain Confidential Disclosure Agreement between the Parties dated 21 January 2021; provided that all “Confidential Information” disclosed or received under such Confidential Disclosure Agreement shall be deemed “Confidential Information” under this Agreement and subject to the terms and conditions of this Agreement). Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release, or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties. 16.12 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. 16.13 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by the Party waiving such term or condition. The waiver by either Party of any right or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein. 16.14 No Benefit to Third Parties. Except as provided in ARTICLE 14, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons. 16.15 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and
104 instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement. 16.16 Relationship of the Parties. Orchard and Pharming are independent contractors and the relationship between the Parties shall not constitute a partnership, joint venture, or agency, including for tax purposes. Neither Party shall have the authority to make any statements, representations, or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of such other Party. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and Cost of such Party. 16.17 Counterparts; Facsimile Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This Agreement may be executed by facsimile or electronically transmitted signatures and such signatures shall be deemed to bind each party hereto as if they were original signatures. {SIGNATURE PAGE FOLLOWS} 7897269 v13 THIS RESEARCH COLLABORATION AND LICENCE AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date. ORCHARD THERAPEUTICS (EUROPE) LIMITED By: Name: Title: PHARMING TECHNOLOGIES B.V. By: Name: Title: 7897269 v13 Schedule 1.123 Pre-Clinical Plan [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] 7897269 v13 [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] [_____] Pre-Clinical Budget 1. [_____] [_____] [_____] [__] [__] [__] [_____] [_____] [___] [__] [__] [__] [_____] [__] [__] [__] [__]
7897269 v13 [_____] [__] [__] [__] [__] [_____] [__] [__] [__] [__] [_____] [__] [__] [__] [__] 2. [_____] 3. [_____] Schedule 1.127 Product Specific Patent Application No. Priority Date Filing Date Status Title [_____] [_____] [_____] [_____] [_____] 7897269 v13 Schedule 1.84 Orchard Background Patents The Product Specific Patent set out in Schedule 1.127, and all Patents claiming priority from or arising from such Product Specific Patent. Schedule 12.4 Form of Press Releases Orchard Therapeutics and Pharming Group Announce Collaboration to Develop and Commercialize ex vivo HSC Gene Therapy for Hereditary Angioedema Highlights the broader potential of Orchard’s ex vivo autologous HSC gene therapy platform approach in new and larger indications Reinforces Pharming’s commitment to the HAE community and utilizes its relevant clinical expertise and global commercialization infrastructure Companies to host joint investor call at 8:00 a.m. EDT / 2:00 p.m. CEST BOSTON, LONDON and LEIDEN, The Netherlands, July 1, 2021 -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, and Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global, commercial stage biopharmaceutical company, today announced a strategic collaboration to research, develop, manufacture and commercialize OTL-105, a newly disclosed investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy for the treatment of hereditary angioedema (HAE), a life-threatening rare disorder that causes recurring swelling attacks in the face, throat, extremities and abdomen. OTL-105 is an investigational HSC gene therapy designed to increase C1 esterase inhibitor (C1-INH) in HAE patient serum to prevent hereditary angioedema attacks. OTL-105 inserts one or more functional copies of the SERPING1 gene into patients own HSCs ex vivo which are then transplanted back into the patient for potential durable C1-INH production. In preclinical studies, to date, OTL-105 demonstrated high levels of SERPING1 gene expression via lentiviral-mediated transduction in multiple cell lines and primary human CD34+ HSCs. Furthermore, the program achieved production of functional C1-INH protein, as measured by a clinically validated assay. Under the terms of the collaboration, Pharming has been granted worldwide rights to OTL-105 and will be responsible for clinical development, regulatory filings, and commercialization of the investigational gene therapy, including associated costs. Orchard will lead the completion of IND-enabling activities and oversee manufacturing of OTL-105 during pre-clinical and clinical development, which will be funded by Pharming. In addition, both companies will explore the application of non-toxic conditioning regimen for use with OTL- 105 administration. Orchard will receive an upfront payment of $17.5 million comprising $10 million in cash and a $7.5 million equity investment from Pharming at a premium to Orchard's recent share price. Orchard is also eligible to receive up to $189.5 million in development, regulatory and sales milestones as well as mid-single to low double-digit royalty payments on future worldwide sales. “Given the combination of our expertise in HSC gene therapy with Pharming’s long-standing legacy and experience, we have the potential to reinvent the treatment paradigm for HAE by providing people living with this life-threatening disorder a sustained therapy with a single administration,” said Bobby Gaspar, M.D., Ph.D., chief executive officer of Orchard Therapeutics. “This collaboration demonstrates the promise of the HSC gene therapy platform and how it can be applied to new therapeutic areas with larger patient populations. We believe the HSC gene therapy pipeline we are building could continue to be a source of future partnerships in areas where the biology supports our approach.” “Pharming has been committed to the HAE community for more than two decades,” said Sijmen de Vries M.D., MBA, chief executive officer of Pharming. “We have partnered with Orchard Therapeutics, a leader in the development of autologous HSC gene therapy, to develop a potentially curative treatment for HAE. Based on Pharming’s experience in HAE, we believe that HSC gene therapy has the potential for the highest probability of success. This confidence is based on the durability of effect and safety observed in approved treatments from Orchard’s HSC gene therapy portfolio and positive clinical data in several other programs. This a significant first step in developing a potentially transformative one-time treatment for HAE.” “Great progress has been made in HAE treatment over the last 15 years. However, HAE remains a severe, debilitating disease with an ongoing burden of angioedema attacks or chronic medication use,” said Dr. Marc Riedl, professor of medicine and clinical director of the U.S. Hereditary Angioedema Association Center at the University of California, San Diego. This promising work toward treatment with the potential for durable long-term clinical benefit is encouraging and signifies an ongoing commitment to the HAE community. I look forward to these efforts to identify and carefully advance a potential cure for HAE.” The HAE market is expected to generate ~$2 billion in sales in 2021, currently growing at 8% per annum. This represents a significant commercial opportunity for Pharming Group and Orchard Therapeutics. Webcast Link: https://webcast.openbriefing.com/pharming-jul21/ Participant Dial-in Details: United Kingdom 0800 640 6441 United Kingdom (Local) 020 3936 2999 United States (Local) 1 646 664 1960 Netherlands 085 888 7233 All other locations +44 20 3936 2999 Access code: 470719 About HAE Hereditary angioedema (HAE) is a rare genetic disorder. The condition is caused by a deficiency of the C1 esterase inhibitor protein, which is normally present in blood and helps control inflammation (swelling) and parts of the immune system. Deficient C1 inhibitor does not adequately perform its regulatory function and, as a result, a biochemical imbalance can occur and produce unwanted peptides that induce the capillaries to release fluids into surrounding tissue, thereby causing swelling or edema.
HAE is characterized by spontaneous and recurrent episodes of swelling (edema attacks) of the skin in different parts of the body, as well as in the airways and internal organs. Edema of the skin usually affects the extremities, the face, and the genitals. Patients suffering from this kind of edema often withdraw from their social lives because of the disfiguration, discomfort and pain these symptoms may cause. Almost all HAE patients suffer from bouts of severe abdominal pain, nausea, vomiting and diarrhea caused by swelling of the intestinal wall. Edema of the throat, nose or tongue is particularly dangerous and potentially life-threatening as it can lead to obstruction of the airway passages. Although there is currently no known cure for HAE, it is possible to treat the symptoms associated with angioedema attacks. HAE affects about 1 in 10,000 to 1 in 50,000 people worldwide. Experts believe a lot of patients are still seeking the right diagnosis: although HAE is (in principle) easy to diagnose, it is frequently identified very late or not discovered at all. The reason HAE is often misdiagnosed is because the symptoms are similar to those of many other common conditions such as allergies or appendicitis. By the time it is diagnosed correctly, the patient has often been through a long ordeal. About Pharming Group N.V. Pharming Group N.V. is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The flagship of our portfolio is our recombinant human C1 esterase inhibitor (rhC1INH) franchise. C1INH is a naturally occurring protein that down regulates the complement and contact cascades in order to control inflammation in affected tissues. Our lead product, RUCONEST®, is the first and only plasma-free rhC1INH protein replacement therapy. It is approved for the treatment of acute hereditary angioedema (HAE) attacks. We are commercializing RUCONEST® in the United States, the European Union and the United Kingdom through our own sales and marketing organization, and the rest of the world through our distribution network. In addition, we are investigating the clinical efficacy of rhC1INH in the treatment of further indications, including pre-eclampsia, acute kidney injury, and severe pneumonia as a result of COVID-19 infections. Furthermore, we are leveraging our transgenic manufacturing technology to develop next-generation protein replacement therapies, most notably for Pompe disease, which is currently in preclinical development. About Orchard Therapeutics Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by severe diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSK’s rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist. Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit www.orchard-tx.com, and follow us on Twitter and LinkedIn. Availability of Other Information About Orchard Therapeutics Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchard’s investor relations website and may include additional social media channels. The contents of Orchard’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Orchard Therapeutics Forward-looking Statements This press release contains certain forward-looking statements about Orchard’s strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include express or implied statements relating to, among other things, Orchard’s business strategy and goals, the therapeutic potential of Orchard’s product candidates, including the product candidate or candidates referred to in this release, and the possibility of future milestone or royalty payments. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchard’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchard’s product candidates, will be insufficient to support regulatory submissions or marketing approval in the US or EU, as applicable, or that long-term adverse safety findings may be discovered; the risk that any one or more of Orchard’s product candidates, including the product candidates referred to in this release, will not be approved, successfully developed or commercialized; the risk of cessation or delay of any of Orchard’s ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the delay of any of Orchard’s regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchard’s product candidates or the receipt of restricted marketing approvals; the inability or risk of delays in Orchard’s ability to commercialize its product candidates, if approved, or Libmeldy in the EU; the risk that the market opportunity for Libmeldy, or any of Orchard’s product candidates, may be lower than estimated; the risk that certain milestones may never be achieved or royalty payments may never be earned and paid; and the severity of the impact of the COVID-19 pandemic on Orchard’s business, including on clinical development, its supply chain and commercial programs. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchard’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission (SEC), as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchard’s views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Pharming Group N.V. Forward-looking Statements This press release contains forward-looking statements, including with respect to timing and progress of Pharming’s preclinical studies and clinical trials of its product candidates, Pharming’s clinical and commercial prospects, Pharming’s ability to overcome the challenges posed by the COVID-19 pandemic to the conduct of its business, and Pharming’s expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming’s clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming’s 2020 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward- looking statements may not occur, and Pharming’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release. Inside Information This press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. Orchard Therapeutics Contacts Investors Renee Leck Director, Investor Relations +1 862-242-0764 Renee.Leck@orchard-tx.com Media Benjamin Navon Director, Corporate Communications +1 857-248-9454 Benjamin.Navon@orchard-tx.com Pharming Group N.V. Contacts Company Pharming Group, Leiden, The Netherlands Sijmen de Vries, CEO +31 71 524 7400 Investors Susanne Embleton Investor Relations Manager +31 71 524 7400 investor@pharming.com Media FTI Consulting, London, UK Victoria Foster Mitchell/Alex Shaw +44 203 727 1000 LifeSpring Life Sciences Communication, Amsterdam, The Netherlands Leon Melens +31 6 53 81 64 27 pharming@lifespring.nl
EX-12
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pharming-exhibit121_04apr24.htm
EX-12.1 CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER
Document
Exhibit 12.1
Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a)
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Sijmen de Vries, certify that:
1.I have reviewed this annual report on Form 20-F of Pharming Group N.V. (the “Company”);
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: April 4, 2024 By: /s/ Sijmen de Vries
Sijmen de Vries, M.D., M.B.A.
Chief Executive Officer
(Principal Executive Officer)
EX-12
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pharming-exhibit122_04apr24.htm
EX-12.2 CERTIFCATION OF THE PRINCIPAL FINANCIAL OFFICER
Document
Exhibit 12.2
Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a)
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Jeroen Wakkerman, certify that:
1.I have reviewed this annual report on Form 20-F of Pharming Group N.V. (the “Company”);
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: April 4, 2024
By: /s/ Jeroen Wakkerman Jeroen Wakkerman
Chief Financial Officer
(Principal Financial Officer)
EX-13
9
pharming-exhibit131_04apr24.htm
EX-13.1 CEO
Document
Exhibit 13.1
Certification by the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Annual Report on Form 20-F of Pharming Group N.V. (the “Company”) for the fiscal year ended December 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Annual Report”), Sijmen de Vries, Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of his knowledge:
(1)The Annual Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2)The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: April 4, 2024 By: /s/ Sijmen de Vries Sijmen de Vries
Chief Executive Officer
(Principal Executive Officer)
EX-13
10
pharming-exhibit132_04apr24.htm
EX-13.2 CFO
Document
Exhibit 13.2
Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Annual Report on Form 20-F of Pharming Group N.V. (the “Company”) for the fiscal year ended December 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Annual Report”), Jeroen Wakkerman, Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of his knowledge:
(1)The Annual Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2)The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: April 4, 2024
By: /s/ Jeroen Wakkerman Jeroen Wakkerman
Chief Financial Officer
(Principal Financial Officer)
EX-15
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pharming-exhibit151_04apr24.htm
EX-15.1 CONSENT DELOITTE
Document
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in Registration Statement No. 333- 260557 on Form S-8 of our reports dated April 3, 2024, relating to the financial statements of Pharming Group N.V. and the effectiveness of Pharming's Group N.V. internal control over financial reporting appearing in this Annual Report on Form 20-F for the year ended December 31, 2023.
/s/ Deloitte Accountants B.V.
Amsterdam, The Netherlands
April 3, 2024
EX-97
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pharming-exhibit971_04apr24.htm
EX-97.1 CLAWBACK POLICY
Document
Pharming Group N.V.
Compensation Clawback Policy
Adopted October 25, 2023
Purpose
The Board of Directors (the “Board,” and each member, a “Director”) of Pharming Group N.V. (the “Company”) has adopted this compensation clawback policy (the “Policy”) which provides for (i) the recoupment of Incentive-Based Compensation (as defined below) in the event of an Accounting Restatement (as defined below) and (ii) the recoupment and/or adjustment of a Bonus (as defined below) from Directors under certain circumstances defined by Dutch law. This Policy is intended to comply with Section 10D of the Securities Exchange Act of 1934 (the “Act”), the rules promulgated thereunder by the Securities and Exchange Commission (the “SEC”), and the listing standards of the Nasdaq Stock Market LLC (“Nasdaq”) (with such rules and listing standards collectively referred to as the “Applicable Rules”), and will be interpreted consistent therewith.
Applicability and Effective Date
This Policy is effective as of October 2, 2023 (the “Effective Date”) and is applicable to all Incentive-Based Compensation received by Executive Officers (as defined below) after the Effective Date and to any Bonus received by Directors, irrespective of whether the Bonus was received before or after the Effective Date. The Policy will be administered by the Board or, if so designated by the Board, the Remuneration Committee of the Board (the “Committee”), in which case references to the Board will be deemed to be references to the Committee. Any determination made by the Board under this Policy will be final and binding. Each Executive Officer shall be required to execute the acknowledgement in Appendix A of this Policy as soon as practicable after the later of (i) the Effective Date or (ii) the date on which the employee is designated as an Executive Officer; provided, however, that failure to execute such acknowledgement shall have no impact on the enforceability of this Policy.
Restatement Clawback
In the event the Company is required to prepare an Accounting Restatement, any Executive Officer who received Excess Compensation (as defined below) during the three (3) completed fiscal years preceding the date the Company is required to prepare an Accounting Restatement (the “Look-Back Period”) shall be required to repay or forfeit such Excess Compensation reasonably promptly.
Method of Repayment, Conditions for Non-Recovery
The Board shall have discretion to determine the appropriate means of recovery of Excess Compensation, which may include, without limitation, direct payment in a lump sum from the Executive Officer, recovery over time, cancellation of outstanding awards, the reduction of future pay and/or awards, and/or any other method which the Board determines is advisable to achieve reasonably prompt recovery of Excess Compensation. At the direction of the Board, the Company shall take all actions reasonable and appropriate to recover Excess Compensation from any applicable Executive Officer, and such Executive Officer shall be required to reimburse the Company for any and all expenses reasonably incurred (including legal fees) by the Company in recovering such Excess Compensation in accordance with this Policy.
The Committee, or in the absence of the Committee, a majority of the independent Directors on the Board, may determine that repayment of Excess Compensation (or a portion thereof) is not required only where it determines that recovery would be impracticable and one of the following circumstances exists: (i) the direct expense paid to a third party to assist in enforcing this Policy would exceed the amount to be recovered, provided the Company has (A) made a reasonable attempt to recover such Incentive-Based Compensation, (B) documented such reasonable attempt, and (C) provided such documentation to Nasdaq; (ii) so long as the Company is a “foreign private issuer,” as defined under the Applicable Rules, recovery would violate home country law where the law was adopted prior to November 28, 2022, provided the Company has (A) obtained an opinion of home country counsel acceptable to Nasdaq that recovery would result in such violation and (B) provided such opinion to Nasdaq; or (iii) recovery would likely cause an otherwise tax-qualified retirement plan, under which benefits are broadly available to employees of the Company, to fail to meet the requirements of 26 U.S.C.
401(a)(13) or 26 U.S.C. 411(a) and the regulations thereunder.
No Fault Application, No Indemnification
Recovery of Excess Compensation under this Policy is on a “no fault” basis, meaning that it will occur regardless of whether the Executive Officer engaged in misconduct or was otherwise directly or indirectly responsible, in whole or in part, for the Accounting Restatement. No Executive Officer may be indemnified by the Company, or any of its affiliates, for losses arising from the application of this Policy.
Definitions
For purposes of this Policy, the following definitions will apply:
“Accounting Restatement” means an accounting restatement due to the material noncompliance of the Company with any financial reporting requirement under securities laws, including any required accounting restatement to correct an error in previously issued financial statements that is material to the previously issued financial statements, or that corrects an error that is not material to previously issued financial statements but would result in a material misstatement if the error were corrected in the current period or left uncorrected in the current period.
Changes to financial statements that do not constitute an Accounting Restatement include retroactive: (i) application of a change from one generally accepted accounting principle to another generally accepted accounting principle; (ii) revisions to reportable segment information due to a change in internal organization; (iii) reclassification due to a discontinued operation; (iv) application of a change in reporting entity, such as from a reorganization of entities under common control; (v) adjustments to provisional amounts in connection with a prior business combination (the extent the Company reports its financial information under International Financial Reporting Standards); and (vi) revisions for stock splits, reverse stock splits, stock dividends, or other changes in capital structure.
“Bonus” means any variable Director compensation that is partly or entirely conditional on the achievement of certain targets or the occurrence of certain events (e.g., signing bonuses, severance pay, cash bonuses, performance awards and contributions to pension funds).
“Excess Compensation” means any amount of Incentive-Based Compensation received by an Executive Officer after commencement of service as an Executive Officer that exceeds the amount of Incentive-Based Compensation that otherwise would have been received had it been determined based on the Accounting Restatement, computed without regard to any taxes paid. For Incentive-Based Compensation based on stock price or total shareholder return, where the amount to be recovered is not capable of mathematical recalculation directly from information in the Accounting Restatement, the amount to be recovered shall be based on a reasonable estimate of the effect of the Accounting Restatement on the stock price or total shareholder return, as applicable, and the Company shall retain documentation of the determination of such estimate and provide such documentation to Nasdaq if so required by the Applicable Rules. Incentive-Based Compensation is deemed received during the fiscal year during which the applicable financial reporting measure, stock price and/or total shareholder return measure, upon which the payment is based, is achieved, even if the grant or payment occurs after the end of such period.
“Executive Officer” means an individual who is, or was during the Look-Back Period, an executive officer of the Company within the meaning of Rule 10D-1(d) under the Act.
“Incentive-Based Compensation” means any compensation that is granted, earned or vested based wholly or in part on stock price, total shareholder return, and/or the attainment of (i) any financial reporting measure(s) that are determined and presented in accordance with the accounting principles used in preparing the Company’s financial statements and/or (ii) any other measures that are derived in whole or in part from such measures.
Compensation that does not constitute “Incentive-Based Compensation” includes equity incentive awards for which the grant is not contingent upon achieving any financial reporting measure performance goal and that vest exclusively upon completion of a specified employment period (except to the extent such awards were granted based on measures described in the previous paragraph), without any performance condition, and bonus awards that are discretionary or based on subjective goals or goals unrelated to financial reporting measures.
Recoupment and Adjustment of a Bonus under Dutch Law
The Company may and, if so directed by the Board shall, recoup all or part of a Bonus that has already been paid to a Director, to the extent payment of such Bonus was based on inaccurate information as to the achievement of targets or the occurrence of events on which the Bonus was based (as determined by the Board acting in good faith). The claim for recoupment of a Bonus will expire after a period of five years has elapsed after the Company became aware that the Bonus was based on inaccurate information.
In addition, the Board may (but is not required to) adjust a Director’s entitlement to a Bonus that has not yet been paid to an appropriate amount, if payment of the (unadjusted) Bonus would be unacceptable according to standards of reasonableness and fairness (as determined by the Board acting in good faith).
Administration, Amendment, and Termination
This Policy will be enforced and, if applicable, appropriate proxy disclosures and exhibit filings will be made in accordance with the Applicable Rules and any other applicable rules and regulations of the SEC.
The Board shall have authority to (i) exercise all of the powers granted to it under the Policy, (ii) construe, interpret, and implement this Policy, and (iii) make all determinations necessary or advisable in administering this Policy.
In addition, the Board may amend this Policy from time to time in its discretion, and shall amend this Policy, as it deems necessary, including to reflect changes in applicable law. The Board may terminate this Policy at any time. Any such amendment (or provision thereof) or termination shall not be effective if such amendment or termination would (after taking into account any actions taken by the Company contemporaneously with such amendment or termination) cause the Company to violate the Applicable Rules.
In the event of any conflict or inconsistency between this Policy and any other policies, plans, or other materials of the Company, this Policy will govern.
This Policy will be deemed to be automatically updated to incorporate any requirement of law, the SEC, exchange listing standard, rule or regulation applicable to the Company.
Appendix A:
Pharming Group N.V.
Compensation Clawback Policy
ACKNOWLEDGMENT
The undersigned acknowledges and agrees that the undersigned (i) is, and will be, subject to the Compensation Clawback Policy to which this acknowledgement is appended (as amended, the “Policy”), (ii) will abide by the terms of the Policy, including by returning Excess Compensation pursuant to whatever method the Board determines is advisable to achieve reasonably prompt recovery of such Excess Compensation, as prescribed under the Policy and (iii) to the extent of any conflict between the Policy and any other agreement or arrangement between the undersigned and the Company or an affiliate of the Company, the Policy shall govern.
Capitalized terms used but not defined have the meanings set forth in the Policy.
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