▪Third-Quarter 2023 Revenues of $13.2 Billion

–Expected Decline in Paxlovid and Comirnaty(1) Revenues Drove 41% Operational Decrease in Third-Quarter 2023 Revenues

–Revenues for Pfizer’s Non-COVID Products Grew 10% Operationally

▪Third-Quarter 2023 Reported(2) Diluted Loss Per Share (LPS) of $(0.42) and Adjusted(3) Diluted LPS of $(0.17), Significantly Impacted by $5.6 Billion of Non-Cash Inventory Write-Offs and Other Charges, Which Unfavorably Impacted Reported(2) and Adjusted(3) Diluted LPS by $0.84

▪Reaffirms Full-Year 2023 Guidance(4) Provided on October 13, 2023, of Revenues of $58.0 to $61.0 Billion and Adjusted(3) Diluted EPS of $1.45 to $1.65, and Provides All Guidance Components

▪Reaffirms Full-Year 2023 Non-COVID Operational Revenue Growth Expectation of 6% to 8% vs. 2022

▪Successful Execution of New Product and Indication Launches, including Abrysvo (Older Adult) and Prevnar 20 (Pediatric), and In-Line Product Growth Contribute to Strong Non-COVID Operational Revenue Growth

▪Launched Enterprise-Wide Cost Realignment Program Expected to Deliver Annual Net Cost Savings of at Least $3.5 Billion, of Which Approximately $1.0 Billion is Expected to be Realized in 2023 and at Least an Additional $2.5 Billion is Expected to be Realized in 2024 (Compared to Midpoint of SI&A and R&D Expense Guidance Provided on August 1, 2023)

NEW YORK, Tuesday, October 31, 2023 — Pfizer Inc. (NYSE: PFE) reported financial results for the third quarter of 2023. The company reaffirms its 2023 revenue guidance(4) range of $58.0 to $61.0 billion and its outlook for Adjusted(3) diluted EPS of $1.45 to $1.65 provided on October 13, 2023.

The third-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: “We are encouraged by the strong performance of Pfizer’s non-COVID products in the third quarter of 2023, including significant contributions from new launches and robust year-over-year growth for several key in-line brands. We also have achieved several recent milestones that speak to the underlying strength and breadth of our scientific pipeline, including the U.S. and European Commission (EC) approval and launch of Abrysvo in pregnant individuals, and EC approval and launch of Abrysvo in older adults; the U.S. approval and launch of Elrexfio; U.S. approvals of Penbraya, Velsipity and of the Braftovi+Mektovi combination in BRAF-mutated metastatic non-small cell lung cancer; and EC approval of Litfulo.

“In addition, we continue to make progress toward our proposed acquisition of Seagen, a global leader in discovering, developing and commercializing transformative oncology medicines that we believe can help us conquer cancer in the coming years—and earlier this month, we received unconditional antitrust clearance from the EC on the proposed acquisition, a decision we believe confirms our view that the transaction is pro-competitive, reflective of our complementary portfolios and good for patients.

“With a significant uncertainty removed by our recently announced amended Paxlovid supply agreement with the U.S. government, our expectation of additional clarification on global vaccination and treatment rates by the end of the year, and the breakthroughs continuing to emerge from our pipeline, we look forward to concluding 2023 with positive momentum that showcases Pfizer’s long-term growth potential.”

David Denton, Chief Financial Officer and Executive Vice President, stated: “We are extremely pleased by the strong 10% operational revenue growth of Pfizer’s non-COVID products in the third quarter of 2023. With expected contributions from our new product launches, this puts us squarely on track to meet our full-year non-COVID operational revenue growth target of 6% to 8%. In addition, we launched our cost realignment program, from which we expect to achieve at least $3.5 billion of net cost savings by the end of 2024. Combined with the momentum of our non-COVID product portfolio and U.S. commercialization of Paxlovid, we expect the program to yield improved operating margins this year and help drive Pfizer’s growth through the end of the decade and beyond.”

Results for the third quarter of 2023 and 2022(5) are summarized below.

($ in millions)			Third-Quarter															Nine Months
			2023			2022			% Change									2023			2022			% Change
									Total			Oper.												Total			Oper.
Global Biopharmaceuticals Business (Biopharma)			$ 12,930			$ 22,319			(42%)			(42%)						$ 43,320			$ 75,066			(42%)			(41%)
Primary Care			6,287			15,846			(60%)			(60%)						23,602			55,676			(58%)			(56%)
Specialty Care			3,757			3,404			10%			12%						11,021			10,267			7%			11%
Oncology			2,885			3,070			(6%)			(5%)						8,696			9,124			(5%)			(3%)
Business Innovation			$ 302			$ 319			(5%)			(7%)						$ 928			$ 974			(5%)			(4%)
TOTAL REVENUES			$ 13,232			$ 22,638			(42%)			(41%)						$ 44,247			$ 76,040			(42%)			(40%)

In the first quarter of 2023, Pfizer established an operating segment, Business Innovation, that includes Pfizer CentreOne (PC1), the company’s global contract development and manufacturing organization and a leading supplier of specialty active pharmaceutical ingredients; and Pfizer Ignite, a recently launched offering that provides strategic guidance and end-to-end R&D services to select innovative biotech companies that align with Pfizer’s R&D focus areas. The prior period has been revised to conform to the current period presentation.

Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(6).

During the first nine months of 2023, Pfizer deployed its capital in a variety of ways, which primarily include the following two categories:

▪Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including $7.9 billion invested in internal research and development projects, and

▪Returning capital directly to shareholders through $6.9 billion of cash dividends, or $1.23 per share of common stock.

No share repurchases have been completed to date in 2023. As of October 31, 2023, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2023.

For the third quarter of 2023, basic weighted-average shares outstanding of 5,646 million were used to calculate Reported(2) and Adjusted(3) diluted LPS.

2023 FINANCIAL GUIDANCE(4)

Pfizer reaffirms its full-year 2023 guidance(4) for Revenues, Adjusted(3) diluted EPS and Effective Tax Rate on Adjusted(3) Income provided on October 13, 2023, which is presented below. This guidance incorporates the impacts of certain one-time items, noted below.

(a) One-time items include a non-cash revenue reversal of approximately $4.2 billion related to the return of an estimated 7.9 million treatment courses of U.S. government EUA-labeled Paxlovid expected in the fourth quarter of 2023 and a non-cash charge of $5.6 billion recorded to Cost of Sales in the third quarter of 2023 for COVID products inventory write-offs and other charges.

* Changes in foreign exchange rates have had a minimal incremental impact since full-year 2023 guidance was issued. Please refer to Press Release Footnote (4) for additional information.

The midpoint of the guidance range for revenues reflects a 40% operational decrease compared to 2022 revenues. Company revenues are anticipated to be lower in 2023 than in 2022 due to expected revenue declines for Pfizer’s COVID-19 products, partially offset by expected operational growth from our non-COVID-19 in-line portfolio, new product and indication launches and recently acquired products.

Excluding COVID-19 products, Pfizer is expecting 6% to 8% operational revenue growth in 2023. Revenue guidance for Pfizer’s COVID-19 products is as follows:

▪Comirnaty(1) revenues of approximately $11.5 billion, down 70% from 2022 results.

▪Paxlovid revenues of approximately $1 billion, down 95% from 2022 results.

▪In contrast to previous years, guidance for both products is no longer based primarily on expected deliveries under existing signed or committed supply contracts, but now also includes, among other things, for Comirnaty(1), transition to traditional commercial market sales in the U.S. in September 2023; and for Paxlovid, expected transition to traditional commercial markets in the U.S. in November 2023, with minimal uptake of New Drug Application (NDA)-labeled commercial product expected before January 1, 2024.

The midpoint of the guidance range for Adjusted(3) diluted EPS reflects a 74% operational decrease compared to 2022, primarily driven by the one-time items referenced in Footnote (a) above, anticipated lower revenues from COVID-19 products, higher spending to support new product and indication launches and greater investment in certain late-stage pipeline projects.

Financial guidance for Adjusted(3) diluted EPS is calculated using approximately 5.72 billion weighted average shares outstanding, and assumes no share repurchases in 2023.

Pfizer also updated certain other components of its 2023 financial guidance, which are presented below. The increase in guidance for Adjusted Cost of Sales as a Percentage of Revenues reflects the impact of the non-cash charge of $5.6 billion recorded to Cost of Sales in the third quarter of 2023 for inventory write-offs and other charges. The decreases in guidance for Adjusted(3) SI&A and R&D Expenses are primarily due to Pfizer’s expectation to realize $1.0 billion of cost savings in 2023 as part of its enterprise-wide cost realignment program. The increase in guidance for Adjusted(3) Other (Income) is primarily due to an improved interest rate environment and anticipated higher income from equity-method investments.

Pfizer’s 2023 financial guidance is based on estimates and assumptions that are subject to significant uncertainties. See the Overview of Our Performance, Operating Environment, Strategy and Outlook — Our 2022 Performance and — The Global Economic Environment sections of Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) in Pfizer’s 2022 Annual Report on Form 10-K; and the Overview of Our Performance, Operating Environment, Strategy and Outlook — Our Second Quarter 2023 and First Six Months of 2023 Performance and — The Global Economic Environment sections of MD&A in Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended July 2, 2023 (available at www.pfizer.com); as well as Pfizer’s press release issued on October 13, 2023 (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-amends-us-government-paxlovid-supply-agreement-and), for additional information.

Third-quarter 2023 revenues totaled $13.2 billion, a decrease of $9.4 billion, or 42%, compared to the prior-year quarter, reflecting an operational decline of $9.3 billion, or 41%, primarily due to a decrease in Paxlovid and Comirnaty(1) revenues globally, as well as a de minimis impact of foreign exchange. Excluding contributions from Comirnaty(1) and Paxlovid, company revenues grew $1.1 billion, or 10%, operationally.

Third-quarter 2023 Paxlovid revenues declined $7.3 billion, or 97%, operationally compared with the prior-year quarter, primarily driven by no third quarter U.S. sales in anticipation of commercial transition and lower contractual deliveries in most international markets.

Third-quarter 2023 Comirnaty(1) revenues declined $3.1 billion, or 70%, operationally compared with the prior-year quarter, largely driven by lower U.S. government contracted deliveries and lower contracted deliveries and demand in international markets, due to anticipated transition to new variant vaccines globally and to traditional U.S. commercial market sales beginning in September 2023.

Excluding contributions from Comirnaty(1) and Paxlovid, third-quarter 2023 operational revenue growth was primarily driven by:

▪U.S. revenues from Abrysvo, which contributed $375 million following FDA approval of the older adult indication in May 2023 and publication of the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommendation in the CDC’s Morbidity and Mortality Weekly Report (MMWR) in July 2023.

▪Nurtec ODT/Vydura and Oxbryta, which were acquired in the fourth quarter of 2022 and contributed $233 million and $85 million in global revenues, respectively;

▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 47% operationally, largely driven by continued strong uptake of the transthyretin amyloid cardiomyopathy (ATTR-CM) indication, primarily in the U.S. and developed Europe; and

▪Prevnar family (Prevnar 13 & 20) globally, up 15% operationally, primarily driven by strong patient demand for Prevnar 20 (adult) in the U.S., the U.S. approval of Prevnar 20 (pediatric) and associated stocking, and growth of Prevenar 13 (pediatric) in certain emerging markets; partially offset by anticipated lower market share for Prevnar (pediatric) in the U.S. due to competitive entry.

GAAP Reported(2) Statement of Operations Highlights

SELECTED REPORTED COSTS AND EXPENSES(2)

Third-quarter 2023 Cost of Sales(2) as a percentage of revenues increased by 43.3 percentage points compared with the prior-year quarter, primarily driven by a non-cash charge of $5.6 billion recorded to Cost of Sales in the third quarter of 2023 for inventory write-offs and other charges ($4.7 billion for Paxlovid and $0.9 billion for Comirnaty(1)).

Third-quarter 2023 SI&A Expenses(2) decreased 3% operationally compared with the prior-year quarter, primarily reflecting a lower provision for U.S. healthcare reform fees related to Comirnaty(1) and Paxlovid and a decrease in spending on products across multiple customer groups, partially offset by increases in marketing and promotional expenses for recently acquired and launched products.

Third-quarter 2023 R&D Expenses(2) increased 1% operationally compared with the prior-year quarter, primarily driven by increased investments to develop recently acquired assets and to support upcoming product launches, partially offset by lower compensation-related expenses.

Third-quarter 2023 Acquired IPR&D Expenses(2) decreased 87% operationally, primarily reflecting the non-recurrence of an upfront payment related to the closing of the acquisition of ReViral Ltd. in the third quarter of 2022.

The favorable period-over-period change in Other income—net(2) of $19 million for the third quarter of 2023, compared to the third quarter of 2022, was primarily driven by (i) a gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion Pharma International Operations Limited, a subsidiary of AstraZeneca PLC, (ii) the non-recurrence of an asset impairment charge incurred in the third quarter of 2022 and (iii) equity income from our investment in Haleon plc in the third quarter of 2023 versus equity losses in the third quarter of 2022; partially offset by (iv) higher net losses on equity securities and (v) lower net periodic benefit credits associated with pension and postretirement plans recorded in the third quarter of 2023.

Pfizer’s positive effective tax rate for the third quarter of 2023 reflects a tax benefit on a pre-tax Reported(2) loss, primarily resulting from the Company’s revised forecast and jurisdictional mix of earnings.

Adjusted(3) Statement of Operations Highlights

SELECTED ADJUSTED(3) COSTS AND EXPENSES

Reconciliations of certain Reported(2) to non-GAAP Adjusted(3) financial measures and associated footnotes can be found in the financial tables section of this press release.

▪Abrilada (adalimumab-afzb) – In October 2023, Pfizer announced the FDA designated Abrilada as an interchangeable biosimilar to Humira(7) (adalimumab). The interchangeable designation applies to all approved indications of Abrilada, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

▪Abrysvo (Respiratory Syncytial Virus Vaccine)

•In August 2023, Pfizer announced the FDA approved Abrysvo, the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. The CDC’s ACIP subsequently recommended Abrysvo for use in pregnant people during 32 through 36 weeks gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in infants. This recommendation was published in the CDC’s MMWR in October 2023, triggering commercial and Medicaid coverage.

•In August 2023, Pfizer announced the EC granted marketing authorization for Abrysvo for passive protection against LRTD caused by RSV in infants from birth through six months of age following maternal immunization during pregnancy (between weeks 24 and 36 of gestation) and for active immunization of individuals 60 years of age and older for the prevention of LRTD caused by RSV. The authorization is valid in all 27 European Union (EU) member states plus Iceland, Liechtenstein and Norway.

▪Braftovi (encorafenib) and Mektovi (binimetinib) – In October 2023, Pfizer announced the FDA approved Braftovi in combination with Mektovi for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. The approval was based on data from the ongoing Phase 2 PHAROS clinical trial, an open-label, multicenter, single‑arm study examining Braftovi + Mektovi combination therapy in both treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic NSCLC.

▪Comirnaty (COVID-19 Vaccine, mRNA)(8)

•In September 2023, Pfizer and BioNTech SE (BioNTech) announced the FDA approved the companies’ supplemental Biologics License Application (Comirnaty 2023-2024 Formulation) for individuals 12 years and older and granted Emergency Use Authorization (EUA) for individuals 6 months through 11 years of age for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. The CDC’s ACIP subsequently recommended a COVID-19 vaccine updated for 2023-2024 for everyone aged 6 months and older; this recommendation was adopted by the CDC Director in September and is now official.

•In August 2023, Pfizer and BioNTech’s Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (Comirnaty Omicron XBB.1.5) received marketing authorization by the EC for individuals 6 months of age and older.

▪Elrexfio (elranatamab-bcmm)

•In October 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending marketing authorization for Elrexfio for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. The EC, which authorizes central marketing approvals in the EU, will take a legally binding decision based on the CHMP recommendation and is expected to make a final decision in the coming months. If granted, the decision will apply to all 27 EU member states plus Iceland, Liechtenstein and Norway.

•In August 2023, Pfizer announced the FDA granted accelerated approval to Elrexfio for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Elrexfio is the first off-the-shelf (ready-to-use) fixed-dose, subcutaneous B-cell maturation antigen (BCMA)-directed agent in the U.S. with the option for every-other-week long-term dosing after 24 weeks of weekly treatment (for patients who have achieved a response and maintained it for at least two months). Approval was based on the results of the single-arm Phase 2 MagnetisMM-3 trial, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s).

▪Litfulo (ritlecitinib) – In September 2023, Pfizer announced the EC granted marketing authorization for Litfulo, a once-daily oral capsule to treat adults and adolescents 12 years of age and older with severe alopecia areata. The marketing authorization for Litfulo is valid in all 27 EU member states and in Iceland, Liechtenstein and Norway. Litfulo is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata and is the first and only treatment to selectively inhibit Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.

▪Paxlovid (nirmatrelvir tablets and ritonavir tablets)(8) – In October 2023, Pfizer announced an amended agreement with the U.S. government, which will facilitate the transition of Paxlovid to traditional commercial markets in November 2023 (with minimal uptake of NDA-labeled commercial product expected before January 1, 2024), with prices to be negotiated with commercial payers and a copay assistance program for eligible privately insured patients. Components of the agreement include:

•A non-cash return of any remaining EUA-labeled U.S. government inventory at the end of 2023, estimated to be 7.9 million treatment courses, with an associated revenue reversal of approximately $4.2 billion;

•The conversion of those remaining EUA-labeled treatment courses previously purchased by the U.S. government to a volume-based credit, which will support continued access to Paxlovid through a U.S. government patient assistance program (PAP) operated by Pfizer. The PAP will provide the estimated 7.9 million treatment courses of FDA-approved, NDA-labeled Paxlovid free of charge to all eligible uninsured, Medicare and Medicaid patients through 2024, and to eligible uninsured and underinsured patients through 2028; and

•The creation of a U.S. Strategic National Stockpile of 1.0 million treatment courses to enable future pandemic preparedness through 2028, to be managed and supplied by Pfizer at no cost to the U.S. government or taxpayers.

For more information on the amended agreement, please visit https://www.pfizer.com/news/press-release/press-release-detail/pfizer-amends-us-government-paxlovid-supply-agreement-and

▪Penbraya (meningococcal groups A, B, C, W and Y vaccine) – In October 2023, Pfizer announced the FDA approved Penbraya, the first and only pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. Penbraya combines the components from Pfizer’s Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease globally. The CDC’s ACIP subsequently recommended Penbraya for adolescents and young adults 16 to 23 years of age when both MenACWY and MenB vaccines are indicated at the same visit to help protect against the five leading causes of meningococcal disease.

▪Velsipity (etrasimod) – In October 2023, Pfizer announced the FDA approved Velsipity, an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). The approval of Velsipity was based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials that were published by The Lancet in March 2023.

A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.

▪Combination COVID-19 & Influenza mRNA Vaccine (PF-07926307) – In October 2023, Pfizer and BioNTech announced positive topline results from a Phase 1/2 study evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age. In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit. The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B and SARS-CoV-2 strains, and that the combination formulations evaluated had a safety profile consistent with the safety profile of the companies’ COVID-19 vaccine. A pivotal Phase 3 trial evaluating these lead formulations is expected to be initiated in the coming months.

▪First-Generation modFlu mRNA Influenza Vaccine Candidate (PF-07252220) – Today, Pfizer announces that both primary endpoints were met in the 18- to 64-year-old cohort of the ongoing Phase 3 trial evaluating its first-generation modFlu mRNA influenza vaccine candidate. In the cohort, the mRNA vaccine candidate demonstrated non-inferiority and superiority to a licensed flu vaccine at the time of the primary analysis.

Efficacy was maintained through the trial’s end of season analysis for the 18- to 64-year-old cohort, with the vaccine candidate remaining non-inferior to the licensed comparator. Both the primary and end of season efficacy analyses considered both influenza A and B cases collectively, though the vast majority of cases recorded in this cohort, and during the 2022/2023 flu season overall, were influenza A cases. Secondary immunogenicity endpoints were achieved only for A strains, not B strains. The safety profile of the mRNA vaccine candidate in the 18- to 64-year-old cohort was similar to that of standard flu vaccine. A readout from the Phase 3 trial’s cohort in adults ages 65 and over is expected later this year.

▪VLA15 (Lyme Disease Vaccine Candidate) – In September 2023, Pfizer and Valneva SE announced positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster. These results from the VLA15-221 Phase 2 study showed a strong anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent (12 to 17 years of age) participants, as well as in adults (18 to 65 years of age), one month after administration of a booster dose (month 19). The safety and tolerability profile of VLA15 after a booster dose was consistent with previous studies, as the vaccine candidate was well-tolerated in all age groups regardless of the primary vaccination schedule. No vaccine-related serious adverse events and no safety concerns were observed by an independent Data Safety Monitoring Board.

▪In October 2023, Pfizer announced that it has launched a multi-year, enterprise-wide cost realignment program that aims to realign its costs with its longer-term revenue expectations. The program is expected to deliver annual net cost savings of at least $3.5 billion, of which approximately $1.0 billion is expected to be realized in 2023 and at least an additional $2.5 billion is expected to be realized in 2024 compared to the midpoint of SI&A and R&D expense guidance provided on August 1, 2023. The one-time costs to achieve the savings associated with the new cost realignment program are expected to be approximately $3.0 billion, of which the majority is expected to be cash. These costs will primarily include severance and implementation costs. Pfizer will continue to refine the estimated savings and their associated costs over the remainder of the year and will incorporate them into its full-year guidance for 2024.

▪In September 2023, Pfizer announced it has restarted the majority of its manufacturing lines at its Rocky Mount, N.C., facility following severe damage from a tornado that hit the site in July 2023. The resumption of production also included the launch of one line in the site’s new sterile injectable manufacturing area referred to as R3, a state-of-the-art module approved earlier this year by the FDA. The first shipments of medicines to distribution centers are anticipated in the fourth quarter of 2023. The expedited restart is the first step toward full recovery for the facility as Pfizer restarts production through a phased approach, with full production across the site’s three manufacturing suites anticipated by the end of 2023.

The supply of medicines impacted by the tornado is expected to be affected until at least mid-2024.

(1)As used in this document, “Comirnaty” refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Comirnaty (COVID-19 Vaccine, mRNA, 2023-2024 Formula), the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), Comirnaty Original/Omicron BA.1, Comirnaty Original/Omicron BA.4/BA.5 and Comirnaty XBB.1.5. “Comirnaty” includes direct sales and alliance revenues related to sales of the above-mentioned vaccines, which are recorded within Pfizer’s Primary Care customer group. It does not include revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech, which are included in the Pfizer CentreOne contract development and manufacturing organization. Revenues related to these manufacturing activities totaled $11 million for the first nine months of 2023 and $108 million for the first nine months of 2022.

(2)Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income/(loss) and its components are defined as net income/(loss) attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) and reported diluted loss per share (LPS) are defined as diluted EPS or LPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP.

(3)Adjusted income/(loss) and Adjusted diluted EPS/(LPS) are defined as U.S. GAAP net income/(loss) attributable to Pfizer Inc. common shareholders and Reported diluted EPS/(LPS) attributable to Pfizer Inc. common shareholders before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the third quarter and the first nine months of 2023 and 2022. Adjusted income/(loss) and its components and Adjusted diluted EPS/(LPS) measures are not, and should not be viewed as, substitutes for U.S. GAAP net income/(loss) and its components and diluted EPS/(LPS)(2). See the Non-GAAP Financial Measure: Adjusted Income section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s 2022 Annual Report on Form 10-K and the accompanying Non-GAAP Financial Measure: Adjusted Income/(Loss) section of this press release for a definition of each component of Adjusted income/(loss) as well as other relevant information.  

(4)Pfizer does not provide guidance for GAAP Reported financial measures (other than revenues and acquired in-process R&D (IPR&D) expenses) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of unusual gains and losses, certain acquisition-related expenses, gains and losses from equity securities, actuarial gains and losses from pension and postretirement plan remeasurements, potential future asset impairments and pending

litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.

Financial guidance for full-year 2023 reflects the following:

▪Does not assume the completion of any business development transactions not completed as of October 1, 2023, except for signed transactions, if any, through mid-October 2023, which are expected to give rise to acquired IPR&D expenses during fiscal 2023.

▪Reflects a non-cash revenue reversal of approximately $4.2 billion related to the return of an estimated 7.9 million treatment courses of U.S. government EUA-labeled Paxlovid expected in the fourth quarter of 2023.

▪Reflects an anticipated negative revenue impact of approximately $0.2 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost patent protection or that are anticipated to lose patent protection during fiscal-year 2023.

▪Reflects expected impacts from certain short-term headwinds, such as the U.S. approval for the Talzenna plus Xtandi combination for the treatment of adult patients with HRR gene-mutated mCRPC, versus an approval in the all-comers population; a shared-clinical decision-making recommendation for Abrysvo (Older Adult) from the CDC’s ACIP, versus a routine recommendation; and recent tornado damage to Pfizer’s facility in Rocky Mount, N.C.

▪Exchange rates assumed are a blend of actual rates in effect through the third quarter of 2023 and end of September 2023 rates for the remainder of the year. Financial guidance reflects the anticipated unfavorable impact of approximately $1.0 billion on revenues and approximately $0.19 on Adjusted(3) diluted EPS as a result of changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2022.

▪Guidance for Adjusted(3) diluted EPS assumes diluted weighted-average shares outstanding of approximately 5.72 billion shares, and assumes no share repurchases in 2023.

(5)Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer’s third quarter and first nine months for U.S. subsidiaries reflects the three and nine months ended on October 1, 2023 and October 2, 2022, while Pfizer’s third quarter and first nine months for subsidiaries operating outside the U.S. reflects the three and nine months ended on August 27, 2023 and August 28, 2022.

(6)References to operational variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although exchange rate changes are part of Pfizer’s business, they are not within Pfizer’s control, and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer’s results.

(7)Humira® is a registered trademark of AbbVie Biotechnology Ltd. Abrilada is interchangeable for the indications of use, dosage forms, strengths and routes of administration described in the prescribing information.

(8)The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) and certain uses of Paxlovid have not been approved or licensed by the FDA. The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) has been authorized by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months through 11 years of age. Paxlovid has been authorized for emergency use by the FDA under an EUA for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product during the COVID-19 pandemic under Section 564(b)(1) of the U.S. Federal Food, Drug and Cosmetic Act unless the declaration is terminated or authorization revoked sooner. Please see the EUA Fact Sheets at www.covid19oralrx.com and www.cvdvaccine-us.com.

*Indicates calculation not meaningful.

(1)The financial statements present the three and nine months ended October 1, 2023 and October 2, 2022. Subsidiaries operating outside the U.S. are included for the three and nine months ended August 27, 2023 and August 28, 2022.

The financial results for the three and nine months ended October 1, 2023 are not necessarily indicative of the results that ultimately could be achieved for the full year.

Business development activities impacted financial results in the periods presented. In May 2023, we issued $31 billion of long-term debt as part of the financing for our proposed acquisition of Seagen Inc. (Seagen). See Notes 1A and 2 to the condensed consolidated financial statements and the Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Business Development Initiatives section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended July 2, 2023, as well as Notes 1A and 2 to the consolidated financial statements in our 2022 Form 10-K. Discontinued operations––net of tax in the periods presented relate to post-close adjustments.

Certain amounts in the consolidated statements of operations and associated notes may not add due to rounding. All percentages have been calculated using unrounded amounts.

(2)For the third quarter and first nine months of 2023, Cost of sales includes a non-cash charge of $5.6 billion recorded in the third quarter of 2023 for inventory write-offs and other charges ($4.7 billion for Paxlovid and $0.9 billion for Comirnaty).

(3)Exclusive of amortization of intangible assets.

(4)Acquired in-process research and development expenses includes costs incurred in connection with (a) all upfront and milestone payments on collaboration and in-license agreements, including premiums on equity securities and (b) asset acquisitions of acquired in-process research and development.

(5)Restructuring charges and certain acquisition-related costs include the following:

(a)Includes charges/(credits) for employee terminations, asset impairments and other exit costs associated with business combinations.

(b)Includes charges/(credits) for employee terminations, asset impairments and other exit costs not associated with acquisitions.

(c)Transaction costs represent external costs for banking, legal, accounting and other similar services.

(d)Integration/pre-integration costs and other represent external, incremental costs directly related to integrating acquired businesses and our proposed acquisition of Seagen, such as expenditures for consulting and the integration of systems and processes, and certain other qualifying costs.

(6)Components of Other (income)/deductions––net include:

(a)The decrease in net interest expense in the third quarter and first nine months of 2023 reflects higher interest expense driven by our $31 billion aggregate principal amount of senior unsecured notes issued in May 2023 as part of the financing for our proposed acquisition of Seagen, which was more than offset by higher interest income on the investment of the net proceeds from the debt issuance.

(b)The third quarter of 2023 includes legal obligations related to pre-acquisition matters and certain product liability expenses related to products discontinued and/or divested by Pfizer. The first nine months of 2023 primarily includes certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer and legal obligations related to pre-acquisition matters. The third quarter and first nine months of 2022 primarily included certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer.

(c)The first nine months of 2023 primarily represents intangible asset impairment charges, including $128 million related to in-process research and development (IPR&D) and developed technology rights for acquired software assets, and $120 million resulting from the discontinuation of a study related to an out-licensed IPR&D asset for the treatment of prostate cancer. The third quarter and first nine months of 2022 represented an IPR&D intangible asset impairment charge resulting from the discontinuation of the PF-07265803 (lamin A/C protein (LMNA)-related dilated cardiomyopathy) clinical program.

(d)The third quarter and first nine months of 2023 includes, among other things, a $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion Pharma International Operations Limited, a subsidiary of AstraZeneca PLC. The first nine months of 2023 also includes, among other things, dividend income of $213 million from our investment in ViiV Healthcare Limited and $211 million from our investment in Nimbus Therapeutics, LLC (Nimbus) resulting from Takeda Pharmaceutical Company Limited’s acquisition of Nimbus’s oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor program subsidiary.

(7)Our effective tax rates for income/(loss) from continuing operations were 28.8% and (6.2)% in the three and nine months ended October 1, 2023, respectively, and 4.0% and 10.5% in the three and nine months ended October 2, 2022, respectively. The positive effective tax rate for the third quarter of 2023 reflects a tax benefit on a pre-tax loss primarily resulting from changes in forecast and jurisdictional mix of earnings. The tax benefit for the third quarter of 2023 and the negative effective tax rate for the first nine months of 2023, compared to the tax provisions for the third quarter and first nine months of 2022, were primarily due to changes in forecast and jurisdictional mix of earnings. The tax provisions for the third quarter and first nine months of 2022 also included tax benefits related to global income tax resolutions in multiple tax jurisdictions spanning multiple tax years that included the closing of U.S. Internal Revenue Service audits covering five tax years.

(8)For the third quarter of 2023, basic weighted-average shares outstanding of 5,646 million (excluding common share equivalents) were used to calculate GAAP Reported Loss per common share attributable to Pfizer Inc. common shareholders––diluted.

Adjusted income/(loss) is an alternative measure of performance used by management to evaluate our overall performance as a supplement to our GAAP Reported performance measures. As such, we believe that investors’ understanding of our performance is enhanced by disclosing this measure. We use Adjusted income/(loss), certain components of Adjusted income/(loss) and Adjusted diluted EPS/(LPS) to present the results of our major operations––the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide––prior to considering certain income statement elements as follows:

(a)Most directly comparable GAAP measure.

(b)Beginning in the first quarter of 2022, we no longer exclude any expenses for acquired IPR&D from our non-GAAP Adjusted results but we continue to exclude certain of these expenses for our financial results for annual incentive compensation purposes.

Adjusted income/(loss) and its components and Adjusted diluted EPS/(LPS) are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, are limited in their usefulness to investors. Because of their non-standardized definitions, they may not be comparable to the calculation of similar measures of other companies and are presented to permit investors to more fully understand how management assesses performance. A limitation of these measures is that they provide a view of our operations without including all events during a period, and do not provide a comparable view of our performance to peers. These measures are not, and should not be viewed as, substitutes for their most directly comparable GAAP measures of Net income/(loss) attributable to Pfizer Inc. common shareholders, components of Net income/(loss) attributable to Pfizer Inc. common shareholders and EPS/(LPS) attributable to Pfizer Inc. common shareholders—diluted, respectively.

We also recognize that, as internal measures of performance, these measures have limitations, and we do not restrict our performance-management process solely to these measures. We also use other tools designed to achieve the highest levels of performance. For example, our R&D organization has productivity targets, upon which its effectiveness is measured. In addition, total shareholder return, both on an absolute basis and relative to a publicly traded pharmaceutical index, plays a significant role in determining payouts under certain of our incentive compensation plans.

See the reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the third quarters and first nine months of 2023 and 2022 below and the Non-GAAP Financial Measure: Adjusted Income section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s 2022 Annual Report on Form 10-K for additional information.

(1)Items that reconcile GAAP Reported to non-GAAP Adjusted balances are shown pre-tax. Our effective tax rates for GAAP Reported income/(loss) from continuing operations were 28.8% and (6.2)% in the three and nine months ended October 1, 2023, respectively, and 4.0% and 10.5% in the three and nine months ended October 2, 2022, respectively. See Note (7) to the Consolidated Statements of Operations above. Our effective tax rates for non-GAAP Adjusted income/(loss) were 22.3% and 10.4% in the three and nine months ended October 1, 2023, respectively, and 4.4% and 11.9% in the three and nine months ended October 2, 2022, respectively.

(2)The amounts for the third quarters and first nine months of 2023 and 2022 include reconciling amounts for Research and development expenses that are not material.

(3)For the third quarter of 2023, basic weighted-average shares outstanding of 5,646 million (excluding common share equivalents) were used to calculate GAAP Reported and non-GAAP Adjusted Loss per common share attributable to Pfizer Inc. common shareholders––diluted.

(4)The amounts for the third quarters and first nine months of 2023 and 2022 relate to post-close adjustments.

(5)Includes employee termination costs, asset impairments and other exit costs related to our cost-reduction and productivity initiatives not associated with acquisitions.

(6)For the third quarter and first nine months of 2023, the total Cost of sales adjustments of $216 million and $238 million, respectively, primarily include $209 million in inventory losses, overhead costs related to the period in which the facility could not operate, and incremental costs resulting from tornado damage to our manufacturing facility in Rocky Mount, NC. For the third quarter of 2023, the total Other (income)/deductions––net adjustment of $85 million primarily includes a $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion Pharma International Operations Limited (Alexion), a subsidiary of AstraZeneca PLC, partially offset by charges of $71 million for certain legal matters, representing legal obligations related to pre-acquisition matters and certain product liability expenses related to products discontinued and/or divested by Pfizer. For the first nine months of 2023, the total Other (income)/deductions––net adjustment of $21 million primarily includes (i) the $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion, and (ii) dividend income of $211 million related to our investment in Nimbus Therapeutics, LLC (Nimbus) resulting from Takeda Pharmaceutical Company Limited’s acquisition of Nimbus’s oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor program subsidiary, partially offset by charges of (i) $246 million for certain legal matters, primarily representing certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer and legal obligations related to pre-acquisition matters, and (ii) $92 million mostly related to our equity-method accounting pro-rata share of intangible asset amortization and impairments, costs of separating from GSK plc (GSK) and restructuring costs recorded by Haleon plc (Haleon). For the third quarter of 2022, the total Other (income)/deductions––net adjustment of $325 million primarily included charges of (i) $212 million mostly representing our equity-method accounting pro rata share of costs of separating from GSK recorded by Haleon/the GSK Consumer Healthcare joint venture (JV), and adjustments to our equity-method basis differences which are also related to the separation of Haleon/the GSK Consumer Healthcare JV from GSK, and (ii) $77 million for certain legal matters, representing certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer. For the first nine months of 2022, the total Other (income)/deductions––net adjustment of $536 million primarily included charges of (i) $273 million mostly representing our equity-method accounting pro rata share of restructuring charges and costs of separating from GSK recorded by Haleon/the GSK Consumer Healthcare JV, and adjustments to our equity-method basis differences which are also related to the separation of Haleon/the GSK Consumer Healthcare JV from GSK, and (ii) $175 million for certain legal matters, primarily representing certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer.

(7)The components of non-GAAP Adjusted Other (income)/deductions––net include the following:

See Note (6) to the Consolidated Statements of Operations above for additional information on the components comprising GAAP Reported Other (income)/deductions––net.

(8)See Note (6) to the Consolidated Statements of Operations above.

See end of tables for notes.