ReViral Ltd.

Pfizer has terminated development of its RSV treatment candidate sisunatovir, a viral inhibitor picked up in its up to $525 million acquisition of ReViral in 2022. The New York drug company — which is facing an activist investor that’s expected to call for major changes at the company — ended a Phase 2/3 trial and a Phase 1 study of the oral inhibitor, according to updates to a federal clinical trials database. “There have been ongoing challenges in the sisunatovir clinical development program, including a drug-drug interaction with antacids,” a Pfizer spokesperson said in an emailed statement to Endpoints News . “While Pfizer has been working diligently to resolve the challenges, we decided to stop the development of sisunatovir.” The company will now focus on “identifying and advancing the development of other investigational therapeutics that have the greatest potential to prevent and treat RSV disease and other viral respiratory pathogens,” the spokesperson said. The cull wasn’t because of safety issues, Pfizer said. The drug, which has FDA fast track designation for both pediatric and adult indications, was still listed on Pfizer’s latest quarterly update in July and still appears on its pipeline page. With the ReViral deal, Pfizer was hoping to be able to both prevent RSV with its vaccine, and treat it with sisunatovir — much as it did for Covid-19 with a vaccine and antiviral pill. And when the companies announced the deal in 2022, then-ReViral CEO Alex Sapir called Pfizer “an optimal partner given their commitment to RSV.” At the time, Pfizer said it expected ReViral’s programs to bring in annual revenue of $1.5 billion or more. Pfizer is one of three pharma companies to market a vaccine for respiratory syncytial virus. The company makes Abrysvo , which was approved in 2023, while Moderna sells mResvia and GSK markets Arexvy. This season’s vaccine uptake has been slower than projected , Wall Street analysts have said. ReViral was one of many targets on which Pfizer has spent its Covid-19 cash. It acquired cancer drug developer Seagen for $43 billion, $11.6 billion to get migraine drugs from Biohaven, and $6.7 billion for Arena Pharmaceuticals and its immuno-inflammatory programs. It also spent $5.4 billion for sickle cell biotech Global Blood Therapeutics — only to pull the main product behind the deal for safety reasons.

The rising demand for vaccine adjuvants is mainly due to the increasing rates of infectious and cancerous diseases. Other significant factors include the heightened need for vaccines for specific illnesses, a greater emphasis on immunization, and the expansion of vaccination programs globally. This trend is projected to persist through the forecast period from 2024 to 2030. LAS VEGAS, Aug. 29, 2024 /PRNewswire/ -- DelveInsight's Vaccine Adjuvants Market Insights report provides the current and forecast market analysis, individual leading vaccine adjuvants companies' market shares, challenges, vaccine adjuvants market drivers, barriers, trends, and key market vaccine adjuvants companies in the market. Key Takeaways from the Vaccine Adjuvants Market Report As per DelveInsight estimates, North America is anticipated to dominate the global vaccine adjuvants market during the forecast period. In the product segment of the vaccine adjuvants market, the oil-in-water emulsion category had a significant revenue share in the vaccine adjuvants Market in 2023. Notable vaccine adjuvants companies such as Dynavax Technologies, GSK plc, Croda International plc, SEPPIC, Novavax, SPI Pharma, Agenus Inc., Aurorium, Merck KGaA, Vaxine Pty Ltd., Hawaii Biotech Inc., CSL, OZ Biosciences, InvivoGen, Allergy Therapeutics, EUBIOLOGICS CO., LTD., Pacific GeneTech Limited, Riboxx GmbH, CaPtivate Pharmaceuticals LLC, Mukta Industries, and several others, are currently operating in the vaccine adjuvants market. In May 2023 Croda International Plc entered into a partnership with Amyris and Botanical Solutions Inc. firstly for biotechnology-derived squalene and secondly with BSI to develop a sustainable QS-21 vaccine adjuvant moving towards plant tissue culture-derived approach rather than the traditional method of extracting QS-21 from soap bark trees. In August 2022, GSK Plc entered into an acquisition with Affinivax, Inc. to develop pneumococcal vaccines. To read more about the latest highlights related to the vaccine adjuvants market, get a snapshot of the key highlights entailed in the Global Vaccine Adjuvants Market Report Vaccine Adjuvants Overview Vaccine adjuvants are substances added to vaccines to enhance the body's immune response to the primary antigen. By stimulating the immune system more effectively, adjuvants can reduce the amount of antigen required and increase the duration of immunity. They play a crucial role in improving the efficacy of vaccines, particularly in cases where the antigen alone might not provoke a strong enough immune reaction. Adjuvants can work through various mechanisms, such as promoting a stronger local immune response at the injection site or facilitating a more robust activation of immune cells. Common types of adjuvants include aluminum salts, which have been used for decades and are known for their safety and effectiveness in boosting antibody responses. More recently, newer adjuvants like oil-in-water emulsions and toll-like receptor agonists have been developed to target specific aspects of the immune system. Research continues to explore and refine adjuvants to enhance vaccine performance, aiming to provide better protection against a range of infectious diseases and improve vaccine responses in different populations, including the elderly and immunocompromised individuals. Vaccine Adjuvants Market Insights In 2023, North America is anticipated to represent the largest share of the vaccine adjuvants market among all regions. This growth is driven by several factors. The region benefits from a well-established healthcare infrastructure and strong research and development capabilities, which stimulate advancements in vaccine adjuvant technologies. Additionally, increasing cases of infectious diseases and the threat of potential pandemics, like influenza or new pathogens, have led to greater investment in vaccine and adjuvant research. Government efforts to expand vaccination programs and enhance public health preparedness are also contributing to market growth. For example, the US Department of Health and Human Services (HHS) launched the HPV VAX NOW campaign in January 2021 to boost HPV vaccination rates among young adults. Similarly, the Government of Canada released updated guidelines on seasonal influenza vaccines for 2022-2023 in August 2022, which is expected to further stimulate market growth. Moreover, market expansion is supported by strategies such as product approvals, launches, and agreements. In November 2022, GSK plc's RSV vaccine candidate for older adults received a priority review from the FDA, indicating significant advancements in treatment or prevention. The combined effect of increased government and nonprofit investment in adjuvant development, alongside various product development activities, is set to drive the North American vaccine adjuvants market throughout the forecast period. To know more about why North America is leading the market growth in the vaccine adjuvants market, get a snapshot of the Vaccine Adjuvants Market Outlook Vaccine Adjuvants Market Dynamics The vaccine adjuvants market is experiencing significant growth driven by i ncreasing vaccine development and the demand for enhanced vaccine efficacy. Adjuvants are critical in improving the immune response to vaccines, which is particularly important as new and more complex pathogens emerge. The surge in research and development efforts, especially following the COVID-19 pandemic, has accelerated the need for innovative adjuvant technologies. Companies are focusing on developing adjuvants that can enhance the effectiveness of vaccines with lower doses, thereby addressing both efficacy and cost concerns. Technological advancements are playing a crucial role in shaping the dynamics of the adjuvants market. The development of novel adjuvants, such as nanoparticle-based and recombinant protein adjuvants, is gaining traction. These new technologies offer improved safety profiles and better control over immune responses. Additionally, the rise of personalized medicine and targeted therapies is driving interest in adjuvants that can be tailored to individual patient needs, further expanding the market potential. The r egulatory landscape and approval processes for vaccine adjuvants are also influencing market dynamics. Stringent regulatory requirements and the need for extensive clinical trials can pose challenges for market entry and innovation. However, successful navigation of these regulatory hurdles can lead to significant rewards, as demonstrated by the successful adjuvants used in COVID-19 vaccines. Companies that can efficiently meet regulatory standards while delivering effective solutions are likely to gain a competitive edge. Moreover, the vaccine adjuvants market is witnessing increased investment and collaboration between pharmaceutical companies, academic institutions, and government agencies. This collaborative approach is essential for advancing research, sharing knowledge, and accelerating the development of new adjuvant technologies. The convergence of resources and expertise from multiple stakeholders is expected to drive innovation and expand the market further. Overall, the vaccine adjuvants market is poised for substantial growth due to technological advancements, rising demand for effective vaccines, and increased investment in research and development. As the global focus on public health and disease prevention continues to intensify, the role of adjuvants in enhancing vaccine efficacy will remain a critical component of the healthcare landscape. Get a sneak peek at the vaccine adjuvants market dynamics @ Vaccine Adjuvants Market Dynamics Analysis Vaccine Adjuvants Market Assessment Vaccine Adjuvants Market Segmentation Vaccine Adjuvants Market Segmentation By Product Type: Oil-In-Water Emulsion, Aluminium Salts, Liposomes, Saponin-Based Adjuvants, and Others Vaccine Adjuvants Market Segmentation By Disease Type: Infectious Diseases, Cancer, and Others Vaccine Adjuvants Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the vaccine adjuvants market are set to emerge as the trendsetter explore @ Vaccine Adjuvants Companies Table of Contents Interested in knowing the vaccine adjuvants market by 2030? Click to get a snapshot of the Vaccine Adjuvants Market Trends Related Reports Vaccines Market Vaccines Market Insight, Competitive Landscape, and Market Forecast – 2030 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key vaccines companies, including GlaxoSmithKline, Bharat Biotech, AstraZeneca, Bavarian Nordic A/S, BioNTech, Sanofi, Merck & Co., Inc, Pfizer Inc, Moderna, Meiji Holdings Co., Ltd., EMERGENT, CSL Limited, Johnson & Johnson, VBI Vaccines Inc., Valneva SE., Novavax, CanSinoBIO, Biokangtai, Dynavax Technologies, Zhi Fei Biological, among others. 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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--(BUSINESS WIRE)-- 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 . EXECUTIVE COMMENTARY 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 $3.5 billion of net cost savings by the end of 2024. Combined with the momentum of our non-COVID product portfolio and U.S. commercialization of Paxlovid, we expect the program to yield improved operating margins this year and help drive Pfizer’s growth through the end of the decade and beyond.” Results for the third quarter of 2023 and 2022(5) are summarized below. OVERALL RESULTS ($ in millions, except per share amounts) Third-Quarter Nine Months 2023 2022 Change 2023 2022 Change Revenues $ 13,232 $ 22,638 (42%) $ 44,247 $ 76,040 (42%) Reported(2) Net Income/(Loss) (2,382) 8,608 * 5,488 26,378 (79%) Reported(2) Diluted EPS/(LPS) (0.42) 1.51 * 0.96 4.60 (79%) Adjusted(3) Income/(Loss) (968) 10,172 * 9,908 31,165 (68%) Adjusted(3) Diluted EPS/(LPS) (0.17) 1.78 * 1.73 5.44 (68%) * Indicates calculation not meaningful. REVENUES ($ 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). CAPITAL ALLOCATION 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. 2023 Financial Guidance(4) One-Time Items Included in Guidance(a) Revenues* $58.0 to $61.0 billion $(4.2) billion Operational(6) Decline vs. Prior Year (41%) to (38%) Decline vs. Prior Year (42%) to (39%) Non-cash Inventory Write-offs(a) $5.6 billion Adjusted(3) Diluted EPS* $1.45 to $1.65 $(1.47) Operational(6) Decline vs. Prior Year (75%) to (72%) Decline vs. Prior Year (78%) to (75%) (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. Adjusted(3) Cost of Sales as a Percentage of Revenues 41.0% to 43.0% (previously 28.0% to 30.0%) Adjusted(3) SI&A Expenses $13.3 to $14.3 billion (previously $13.8 to $14.8 billion) Adjusted(3) R&D Expenses $11.9 to $12.9 billion (previously $12.4 to $13.4 billion) Acquired IPR&D Expenses(4) Approximately $0.1 billion Adjusted(3) Other (Income)/Deductions Approximately $1.9 billion of income (previously approximately $1.5 billion of income) Effective Tax Rate on Adjusted(3) Income Approximately 12.0% 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 ); as well as Pfizer’s press release issued on October 13, 2023 ( ), for additional information. QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2023 vs. Third-Quarter 2022) 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 $85 million in global revenues, respectively; Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 47% operationally, largely driven by continued strong uptake of the transthyretin amyloid cardiomyopathy (ATTR-CM) indication, primarily in the U.S. and developed Europe; and Prevnar family (Prevnar 13 & 20) globally, up 15% operationally, primarily driven by strong patient demand for Prevnar 20 (adult) in the U.S., the U.S. approval of Prevnar 20 (pediatric) and associated stocking, and growth of Prevenar 13 (pediatric) in certain emerging markets; partially offset by anticipated lower market share for Prevnar (pediatric) in the U.S. due to competitive entry. GAAP Reported(2) Statement of Operations Highlights SELECTED REPORTED COSTS AND EXPENSES(2) ($ in millions) Third-Quarter Nine Months 2023 2022 % Change 2023 2022 % Change Total Oper. Total Oper. Cost of Sales(2) $ 9,269 $ 6,063 53% 49% $ 17,391 $ 24,696 (30%) (31%) Percent of Revenues 70.0% 26.8% N/A N/A 39.3% 32.5% N/A N/A SI&A Expenses(2) 3,281 3,391 (3%) (3%) 10,196 9,032 13% 15% R&D Expenses(2) 2,711 2,696 1% 1% 7,864 7,813 1% 1% Acquired IPR&D Expenses(2) 67 524 (87%) (87%) 122 880 (86%) (86%) Other (Income)/Deductions––net(2) (79) (59) 33% 50% (356) 1,063 * * Effective Tax Rate on Reported(2) Income/(Loss) 28.8% 4.0% (6.2%) 10.5% * Indicates calculation not meaningful. 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 $19 million for the third quarter of 2023, compared to the third quarter of 2022, was primarily driven by (i) a gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion Pharma International Operations Limited, a subsidiary of AstraZeneca PLC, (ii) the non-recurrence of an asset impairment charge incurred in the third quarter of 2022 and (iii) equity income from our investment in Haleon plc in the third quarter of 2023 versus equity losses in the third quarter of 2022; partially offset by (iv) higher net losses on equity securities and (v) lower net periodic benefit credits associated with pension and postretirement plans recorded in the third quarter of 2023. Pfizer’s positive effective tax rate for the third quarter of 2023 reflects a tax benefit on a pre-tax Reported(2) loss, primarily resulting from the Company’s revised forecast and jurisdictional mix of earnings. Adjusted(3) Statement of Operations Highlights SELECTED ADJUSTED(3) COSTS AND EXPENSES ($ in millions) Third-Quarter Nine Months 2023 2022 % Change 2023 2022 % Change Total Oper. Total Oper. Adjusted(3) Cost of Sales $ 8,906 $ 6,038 47% 44% $ 16,723 $ 24,621 (32%) (33%) Percent of Revenues 67.3% 26.7% N/A N/A 37.8% 32.4% N/A N/A Adjusted(3) SI&A Expenses 3,205 3,239 (1%) (1%) 9,974 8,635 16% 17% Adjusted(3) R&D Expenses 2,679 2,693 (1%) — 7,797 7,799 — 1% Adjusted(3) Other (Income)/Deductions––net (388) (515) (25%) (23%) (1,466) (1,298) 13% 5% Effective Tax Rate on Adjusted(3) Income/(Loss) 22.3% 4.4% 10.4% 11.9 % Reconciliations of certain Reported(2) to non-GAAP Adjusted(3) financial measures and associated footnotes can be found in the financial tables section of the press release located at the link below. RECENT NOTABLE DEVELOPMENTS (Since August 1, 2023) Product Developments 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 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. Pipeline Developments A comprehensive update of Pfizer’s development pipeline was published today and is now available at . 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 pro with the safety pro 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 pro 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 pro 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. Corporate Developments 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. Additional Developments 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. Please find Pfizer’s press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink: (Note: If clicking on the above link does not open a new webpage, you may need to cut and paste the above URL into your browser's address bar.) For additional details, see the financial schedules and product revenue tables attached to the press release located at the hyperlink above, and the attached disclosure notice. (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 and . DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of October 31, 2023. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments. This earnings release and the related attachments contain forward-looking statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; reorganizations; business plans, strategy and prospects; our Environmental, Social and Governance (ESG) priorities, strategy and goals; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data, revenue contribution and projections, potential pricing and reimbursement, potential market dynamics, size and utilization rates, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; an enterprise-wide cost realignment program, which we launched in October 2023 (including anticipated costs, savings and potential benefits); dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, including our proposed acquisition of Seagen, and our ability to successfully capitalize on these opportunities; manufacturing and product supply; our ongoing efforts to respond to COVID-19, including Comirnaty (as defined in this earnings release) and our oral COVID-19 treatment (Paxlovid); and our expectations regarding the impact of COVID-19 on our business, operations and financial results. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions and we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: Risks Related to Our Business, Industry and Operations, and Business Development: the outcome of research and development (R&D) activities, including, the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; risks associated with preliminary, early stage or interim data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; and whether and when additional data from our pipeline programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval for new products and indications from regulators on a timely basis or at all; regulatory decisions impacting labeling, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; uncertainties regarding the ability to obtain, and the scope of, recommendations by technical or advisory committees; and the timing of, and ability to obtain, pricing approvals and product launches, all of which could impact the availability or commercial potential of our products and product candidates; claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the outcome of post-approval clinical trials, which could impact marketing approval, product labeling, and/or availability or commercial potential, including uncertainties regarding the commercial or other impact of the results of the Xeljanz ORAL Surveillance (A3921133) study or actions by regulatory authorities based on analysis of ORAL Surveillance or other data, including on other Janus kinase (JAK) inhibitors in our portfolio; the success and impact of external business development activities, including the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which could result in increased leverage and/or a further downgrade of our credit ratings; challenges integrating the businesses and operations; disruption to business and operations relationships; risks related to growing revenues for certain acquired products; significant transaction costs; and unknown liabilities; risks and uncertainties related to Pfizer’s proposed acquisition of Seagen, including, among other things, risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; risks related to the ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of the announcement or the consummation of the proposed acquisition on the market price of Pfizer’s common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition or Seagen’s business; risks related to the financing of the transaction; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; the impact of the proposed acquisition on future business combinations or disposals; uncertainties regarding the commercial success of Pfizer’s and Seagen’s commercialized and pipeline products; the uncertainties inherent in R&D; whether and when drug applications may be filed in any jurisdictions for Pfizer’s or Seagen’s pipeline products; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such products will be commercially successful; and competitive developments; competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product candidates; the ability to successfully market both new and existing products, including biosimilars; difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on; and legal or regulatory actions; the impact of public health outbreaks, epidemics or pandemics (such as COVID-19) on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials; risks and uncertainties related to our efforts to develop and commercialize our COVID-19 products, as well as challenges related to their manufacturing, supply and distribution, including, among others, the risk that as the market for COVID-19 products becomes more endemic and seasonal, demand for any of our COVID-19 products has and may continue to be reduced or not meet expectations, or may no longer exist, which has and may continue to lead to reduced revenues, excess inventory on-hand and/or in the channel which, for Paxlovid and Comirnaty, has resulted in significant inventory write-offs in the third quarter of 2023 and could continue to result in inventory write-offs or other unanticipated charges; challenges related to the transition to the commercial market for our COVID-19 products; uncertainties related to the public’s adherence to vaccines, boosters and treatments; risks related to our ability to achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments; uncertainties inherent in R&D, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 data for Comirnaty or any vaccine candidate in the BNT162 program or Paxlovid or any future COVID-19 treatment) in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data or further information regarding the quality of pre-clinical, clinical or safety data, including by audit or inspection; the ability to produce comparable clinical or other results for Comirnaty, any vaccine candidate or other vaccines that may result from the BNT162 program, Paxlovid or any future COVID-19 treatment or any other COVID-19 program, including the rate of effectiveness and/or efficacy, safety and tolerability pro to date, in additional analyses of the Phase 3 trial for any such products and additional studies, in real-world data studies or in larger, more diverse populations following commercialization; the ability of Comirnaty, any vaccine candidate or any future vaccine to prevent, or Paxlovid or any future COVID-19 treatment to be effective against, COVID-19 caused by emerging virus variants; the risk that use of Comirnaty or Paxlovid will lead to new information about efficacy, safety or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program, Paxlovid or other COVID-19 programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from existing or future pre-clinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for Comirnaty or any future vaccines in additional populations, for a potential booster dose for Comirnaty, any vaccine candidate or any potential future vaccines (including potential future annual boosters or re-vaccinations), and/or biologics license and/or EUA applications or amendments to any such applications may be filed in particular jurisdictions for Comirnaty, any vaccine candidates or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such EUA or licenses, or existing EUAs, will expire or terminate; whether and when submissions to request emergency use or conditional marketing authorizations for Paxlovid or any future COVID-19 treatment and/or any drug applications and/or EUA applications or amendments to any such applications for any indication for Paxlovid or any future COVID-19 treatment may be filed in particular jurisdictions, and if obtained, whether or when such EUA or licenses, or existing EUAs, will expire or terminate; whether and when any application that may be pending or filed for Comirnaty, any vaccine candidate or other vaccines that may result from the BNT162 program, Paxlovid or any future COVID-19 treatment or any other COVID-19 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s or drug’s benefits outweigh its known risks and determination of the vaccine’s or drug’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine or drug, including the authorization or approval of products or therapies developed by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers, including our relationship with BioNTech; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test any such products; challenges related to our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; challenges and risks related to medication errors such as prescribing or dispensing the wrong strength, improper dosing and self-administration errors; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines, potential combination respiratory vaccines or next generation COVID-19 treatments; the risk that we may not be able to recoup costs associated with our R&D and manufacturing efforts; risks associated with any changes in the way we approach or provide research funding for the BNT162 program, Paxlovid or any other COVID-19 program; challenges and risks associated with the pace of our development programs; the risk that we may not be able to maintain manufacturing capacity or access to logistics or supply channels commensurate with global demand for our COVID-19 products, which would negatively impact our ability to supply our COVID-19 products within the projected time periods; whether and when additional supply or purchase agreements will be reached or existing agreements will be completed or renegotiated; uncertainties regarding the ability to obtain recommendations from vaccine or treatment advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; pricing and access challenges for such products; challenges related to public confidence in, or awareness of Comirnaty or Paxlovid, including challenges driven by misinformation or disinformation, access, concerns about clinical data integrity, or prescriber and pharmacy education; uncertainties around future changes to applicable healthcare policies and guidelines issued by the U.S. federal government in connection with the declared termination of the federal government’s COVID-19 public health emergency as of May 11, 2023; trade restrictions; potential third-party royalties or other claims related to Comirnaty or Paxlovid; and competitive developments; trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products; interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations and monetary policy actions in countries experiencing high inflation rates; any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues, including contract negotiations or renegotiations with government customers; the impact of the increased presence of counterfeit medicines or vaccines in the pharmaceutical supply chain; any significant issues related to the outsourcing of certain operational and staff functions to third parties; and any significant issues related to our JVs and other third-party business arrangements; uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions, such as inflation, and recent and possible future changes in global financial markets; the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, unstable governments and legal systems and inter-governmental disputes; the impact of disruptions related to climate change and natural disasters, including uncertainties related to the impact of the recent tornado at our manufacturing facility in Rocky Mount, N.C.; any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, political or civil unrest or military action, including the ongoing conflicts between Russia and Ukraine and in the Middle East and their economic consequences; the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, including our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines; trade buying patterns; the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments; the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives and growth strategies, and cost-reduction and productivity initiatives, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs, organizational disruption or other unintended consequences; the ability to successfully achieve our climate goals and progress our environmental sustainability and other ESG priorities; Risks Related to Government Regulation and Legal Proceedings: the impact of any U.S. healthcare reform or legislation or any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs, including the Inflation Reduction Act of 2022, or changes in the tax treatment of employer-sponsored health insurance that may be implemented; U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, reimbursement or access or restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive insurance markets; legislation or regulatory action in markets outside of the U.S., such as China or Europe, including, without limitation, laws related to pharmaceutical product pricing, intellectual property, medicine safety, environmental impact of medicines, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets; legal defense costs, insurance expenses, settlement costs and contingencies, including those related to actual or alleged environmental contamination; the risk and impact of an adverse decision or settlement and the risk related to adequacy of reserves related to legal proceedings; the risk and impact of tax related litigation and investigations; governmental laws and regulations affecting our operations, including, without limitation, the Inflation Reduction Act of 2022, changes in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in the U.S., the adoption of global minimum taxation requirements outside the U.S. and potential changes to existing tax law by the current U.S. Presidential administration and Congress; Risks Related to Intellectual Property, Technology and Security: any significant breakdown or interruption of our information technology systems and infrastructure (including cloud services); any business disruption, theft of confidential or proprietary information, security threats on facilities or infrastructure, extortion or integrity compromise resulting from a cyber-attack or other malfeasance by, but not limited to, nation states, employees, business partners or others; the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all; and risks to our products, patents and other intellectual property, such as: (i) claims of invalidity that could result in loss of exclusivity; (ii) claims of patent infringement, including asserted and/or unasserted intellectual property claims; (iii) claims we may assert against intellectual property rights held by third parties; (iv) challenges faced by our collaboration or licensing partners to the validity of their patent rights; or (v) any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products, including Comirnaty and Paxlovid. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether. The information contained on our website or any third-party website is not incorporated by reference into this earnings release. All trademarks mentioned are the property of their owners. View source version on businesswire.com: Contacts Media PfizerMediaRelations@Pfizer.com 212.733.1226 Investors IR@Pfizer.com 212.733.4848 Source: Pfizer Inc. View this news release online at: