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What Changed
Risk factors · Feb 27, 2025 → Feb 26, 2026
84 added · 111 removed between the two most recent 10-Ks. The risks a company starts — or stops — disclosing are often the story.
Newly disclosed
Pfizer Inc. 2025 Form 10-K 2 • 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, including any potential future phases, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs, organizational disruption, adverse effects on employee morale, retention issues or other unintended consequences; • the ability to successfully achieve our climate-related goals and progress our environmental and other sustainability priorities;
Government; • U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, including international reference pricing (including Most-Favored-Nation drug pricing), intellectual property, product approval processes and pathways, reimbursement or access to or recommendations for our medicines and vaccines, tax changes or other 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 biopharmaceutical markets; • risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S., including: (i) risks and uncertainties relating to the evolving vaccine landscape; and (ii) the FDA's recently adopted policy of disclosing Complete Response Letters for unapproved drug candidates and the attendant risk of disclosure of trade secrets or confidential commercial information; • legislation or regulatory action and/or policy efforts in markets outside of the U.S., such as China or Europe, including, without limitation, laws related to pharmaceutical product pricing, intellectual property, medical regulation, environmental protections, data protection and cybersecurity, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain products to control costs in those markets; • legal defense costs, insurance expenses, settlement costs and contingencies, including without limitation, those related to legal proceedings and actual or alleged environmental contamination; • the risk and impact of an adverse decision or settlement and risk related to the adequacy of reserves related to legal proceedings; • the risk and impact of tax related litigation and investigations; • governmental laws, regulations and policies affecting our operations, including, without limitation, the IRA, as well as changes in such laws, regulations or policies, or their interpretation, including, among others, new or changes in tariffs, tax laws and regulations internationally and in the U.S., including the OBBBA, which was enacted on July 4, 2025, and is still subject to further guidance; the adoption of global minimum taxation requirements outside the U.S. generally effective in most jurisdictions since January 1, 2024, government cost-cutting measures and related impacts on, among other matters, government staffing, resources and ability to timely review and process regulatory or other submissions; restrictions related to certain data transfers, including data security, data localization and cross border data transfer regulations, and transactions involving certain countries; and potential changes to existing tax laws, tariffs, or changes to other laws, regulations or policies in the U.S., including by the U.S.
Pfizer Inc. 2025 Form 10-K 4 • Specialty Care: ◦ Inflammation & immunology product portfolio – select products include: Xeljanz, Enbrel (outside the U.S. and Canada), Cibinqo, Litfulo, Eucrisa and Velsipity. ◦ Rare disease product portfolio for a number of therapeutic areas with rare diseases, including amyloidosis, hemophilia and endocrine diseases – select products include: the Vyndaqel family, Genotropin, BeneFIX, Xyntha, Somavert, Ngenla and Hympavzi. ◦ Certain anti-infective and immunoglobulin medicines – select products include: Zavicefta (outside the U.S. and Canada), Octagam and Panzyga. • Oncology: ◦ Innovative oncology product portfolio of ADCs, small molecules, bispecifics and other immunotherapies that treat a wide range of cancers including certain types of breast cancer, genitourinary cancer and hematologic malignancies, as well as certain types of melanoma, gastrointestinal, gynecological and lung cancer – select products include: Ibrance, Xtandi, Padcev, Adcetris, Inlyta, Lorbrena, Bosulif, Tukysa, Braftovi, Mektovi, Orgovyx, Elrexfio, Tivdak and Talzenna. • Hospital and Biosimilars: ◦ Product portfolio of off-patent branded and generic sterile injectables, oncology biosimilars and biosimilars for chronic immune and inflammatory diseases – select products include : Biosimilars – Inflectra, Oncology biosimilars such as Retacrit, Ruxience, Zirabev, Trazimera and Nivestym, and other biosimilars; and Sterile Injectables – Sulperazon (outside the U.S. and Canada), Atgam, Fragmin, Solu Medrol, Solu Cortef and Bicillin.
Basic Product Patent Expiration Year (1) Major Europe Basic Product Patent Expiration Year (1) Japan Basic Product Patent Expiration Year (1) Xeljanz 2026 2028 (2) 2025 Prevnar 13/Prevenar 13 2026 (3) 2029 Adcetris (4) 2026 (4) (4) Eliquis 2027 (5) 2026 (6) 2026 Ibrance 2027 2028 2028 Xtandi (7) 2027 (7) (7) Vyndaqel/Vyndamax/Vynmac 2026 (2028 pending PTE) (8) 2026 2026/2029 (9) Xalkori 2029 2027 (10) 2028 Pfizer Inc. 2025 Form 10-K 7 Product U.S.
For example, approximately $500 million of R&D savings achieved from our ongoing realigning our cost base program in 2025 is expected to be reinvested in R&D programs in 2026.
Pfizer Inc. 2025 Form 10-K 12 In addition, some states have enacted laws seeking to address various aspects of manufacturer policies related to contract pharmacy transactions in their states.
Governmental shutdowns, including impacts on governmental agencies due to a shutdown; • the risk and impact of tariffs on our business, which is subject to a number of factors including, but not limited to, restrictions on trade, the effective date and duration of such tariffs, countries included in the scope of tariffs, changes to amounts of tariffs, and potential retaliatory tariffs or other retaliatory actions imposed by other countries; • the impact of disruptions related to climate change and natural disasters; • any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, political or civil unrest or military action and the resulting economic or other consequences; • the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, such as our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines , and our voluntary withdrawal of all lots of Oxbryta in all markets where it is approved and any regulatory or other impact on Oxbryta and other sickle cell disease assets; • trade buying patterns; • the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
Government designed to lower drug costs for U.S. patients and to include certain Pfizer products on the TrumpRx.gov platform, Pfizer’s plans to further invest in U.S. manufacturing and potential tariff impacts, including risks relating to entering into binding final agreements with the U.S.
For a discussion of our strategy and our business development initiatives, including our acquisitions of Metsera in November 2025 and Seagen in December 2023 and our in-licensing agreements with YaoPharma and 3SBio entered into in 2025 in the obesity and cardiometabolic diseases and oncology therapeutic areas, see the Overview of Our Performance, Operating Environment, Strategy and Outlook section within MD&A and Note 2 .
As part of our continued focus on commercial execution, at the beginning of 2026, we made changes in our commercial structure, which included the transition of certain off-patent branded and generic sterile injectables and biosimilars from the Specialty Care and Oncology product portfolios to a new Global Hospital and Biosimilars organization within our Biopharma reportable segment.
Customer groups and select products within the Biopharma product portfolio in 2026 include: • Primary Care: ◦ Internal medicine product portfolio including in cardiovascular metabolic diseases – select products include: Eliquis, as well as other brands that have experienced patent-based expirations or loss of regulatory exclusivity. ◦ Migraine product portfolio: Nurtec ODT/Vydura and Zavzpret. ◦ Vaccines product portfolio across all ages – select products include: the Prevnar family, Comirnaty, Abrysvo, FSME/IMMUN-TicoVac, Nimenrix and Trumenba. ◦ Treatment for COVID-19: Paxlovid.
Risks Related to Government Regulation and Legal Proceedings : • the impact of any U.S. healthcare reform or legislation or any significant spending reduction or cost control efforts affecting Medicare, Medicaid, the 340B Program or other publicly funded or subsidized health programs, including the IRA, 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 to or recommendations for our medicines and vaccines, taxes or other 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 biopharmaceutical 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, medical regulation, environmental protections, reimbursement or access, Pfizer Inc. 2024 Form 10-K 2 including, in particular, continued government-mandated reductions in prices and access restrictions for certain products to control costs in those markets; • legal defense costs, insurance expenses, settlement costs and contingencies, including without limitation, those related to legal proceedings and actual or alleged environmental contamination; • the risk and impact of an adverse decision or settlement and risk related to the adequacy of reserves related to legal proceedings; • the risk and impact of tax related litigation and investigations; • governmental laws, regulations and policies affecting our operations, including, without limitation, the IRA, as well as changes in such laws, regulations or policies, or their interpretation, including, among others, changes in tariffs, tax laws and regulations internationally and in the U.S., the adoption of global minimum taxation requirements outside the U.S. generally effective in most jurisdictions since January 1, 2024 and potential changes to existing tax laws, tariffs, or changes to other laws, regulations or policies in the U.S., including by the U.S.
While additional patent-based or regulatory exclusivity Pfizer Inc. 2024 Form 10-K 8 expiries will continue, we expect a moderate impact of reduced revenues due to patent expiries in 2025 and anticipate a more significant impact of reduced revenues from patent-based or regulatory exclusivity expiries in 2026 through 2030 as several of our in-line products experience these expirations.
Pfizer Inc. 2024 Form 10-K 5 • Eliquis (apixaban) is part of the Novel Oral Anticoagulant market and was jointly developed and commercialized with BMS as an alternative treatment option to warfarin in appropriate patients.
In several emerging market countries and multilateral institutions, governments continue to address the role of intellectual property in the context of, for example, access to medicines.
As part of our continued focus on commercial execution, at the beginning of 2025, we made changes in our commercial structure, which included the transition of all activities within the Pfizer Oncology Division to other parts of Biopharma, among other changes.
Basic Product Patent Expiration Year (1) Major Europe Basic Product Patent Expiration Year (1) Japan Basic Product Patent Expiration Year (1) Comirnaty (17) 2041 (18)(19) 2041 Paxlovid 2041 2041 2041 (1) Unless otherwise indicated, the years pertain to the basic product patent expiration, including granted PTEs, supplementary protection certificates (SPC) or pediatric exclusivity periods.
For additional information on the impact of loss of patent-based exclusivity or regulatory exclusivity on our revenues, see the Overview of Our Performance, Operating Environment, Strategy and Outlook—Our 2023 Performance section within MD&A.
In August 2024, the government released the new Medicare price for Eliquis, which, effective January 1, 2026, will be required to be offered to all Medicare beneficiaries and to covered entities participating in the 340B Program that dispense Eliquis to a Medicare beneficiary if that maximum fair price is lower than the discounted price such entities are offered under the 340B Program ceiling price calculation.
Additionally, in September 2024, CMS finalized a new rule that, among other items, expands the scope of medications considered to be “covered outpatient drugs” that could be subject to rebates under the MDRP and imposes penalties on covered outpatient drugs that CMS determines to be “misclassified.” Many pharmaceutical manufacturers believe the 340B Program continues to expand beyond the original intent of serving low-income/uninsured patients.
The OMI concluded its work in September 2022, and the WHO/Europe Access to Novel Medicines Platform was established to enhance affordable and equitable access to effective, innovative and high-priced medicinal products in the region.
Several manufacturers have challenged HRSA’s enforcement letters in federal court and litigation is ongoing in certain of those cases, and were resolved in favor of the manufacturers in others.