Risk factor changes · PFE

What changed in Pfizer's risk factors

Item 1A (Risk Factors) of Pfizer's FY2025 10-K compared with its FY2024 10-K, sentence by sentence.

Newer: 10-K filed 2026-02-26 · Older: 10-K filed 2025-02-27

New in the latest 10-K 54

• Some payers are directing beneficiaries to third-party patient assistance programs, rather than covering certain treatments.
• In other instances, insurers disallow manufacturers co-pay assistance from counting toward reaching the deductible or out-of-pocket maximum.
• Both approaches can delay access to treatment or result in treatment abandonment.
• Further, consumers are facing responsibility for a larger portion of their prescription costs, or administrative hurdles to access, and may favor lower-cost, or generic alternatives, or seek direct-to-consumer medications outside of insurance plans.
• In addition to the impact of competitive product launches, we are facing an increasing number of potential competitors worldwide, including from China, that have expanded R&D capabilities.
• Several manufacturers, including Pfizer, have signed voluntary agreements with the Trump Administration designed to ensure U.S. patients pay lower prices for their prescription medicines.
• This may impact the competitive environment, including pricing dynamics for any of our current or potential future products, as well as contracting with payers.
• Furthermore, our recent business development initiatives have been concentrated in certain therapeutic areas for example, our acquisitions of Metsera and Seagen represent significant investments in obesity and oncology, respectively, which are extremely competitive therapeutic areas.
• In addition, revenues from Comirnaty and Paxlovid have decreased substantially over time and could continue to decrease.
• In addition, changes in the commercial landscape may impact our decisions around future product development.
• As discussed above, in September 2025, Pfizer entered into a voluntary agreement with the Trump Administration and will receive a three-year grace period during which time Pfizer products will not face Section 232 tariffs, provided we further invest in manufacturing in the U.S.
• We face risks and uncertainties associated with the agreement and negotiating the binding final agreement, including the possibility of, among other things, unfavorable terms and increased costs related to tariffs and investment requirements and our ability to meet those investment requirements, as well as the possibility of tariffs that could be outside the scope of the agreement.
• If nitrosamines are detected in products, this may lead to submission of comprehensive data packages to regulatory authorities to support discussions on the relevant intake limit for the product and potential impact on patient supply, and, in some instances, may lead to market action for such products.
• Following issuance of updated guidance on acceptable intake limits for N-nitroso-varenicline by regulatory authorities, in 2025, Chantix returned to market in the U.S. and in certain international markets.
• For instance, government cuts to Affordable Care Act (ACA) subsidies and state Medicaid funding could have a material impact on the pricing and demand for our products.
• For example, in May and July 2025, the Trump Administration issued the MFN Initiatives and, in September 2025, we announced an agreement with the Trump Administration in which we voluntarily agreed to implement measures designed to make certain drug prices for U.S. patients more comparable to those in other developed countries (the MFN Agreement).
• We are also participating in the TrumpRx.gov platform, which allows U.S. patients to purchase certain medicines at significant discounts to current retail prices.
• These discounts may adversely affect revenue generated from participating drugs.
• Further, we face risks and uncertainties associated with the MFN Agreement, including the possibility of, among other things, unfavorable impacts to pricing and access.
• The MFN Agreement and broader U.S. policy efforts to implement measures designed to make certain drug prices for U.S. patients more comparable to those in other developed countries is subject to risks and uncertainties and could, among other things, negatively impact our pricing strategies, product demand or access, or competitive positioning across global markets, and may adversely affect revenues in certain markets.
• Xeljanz was included in the list of 15 drugs selected.
• Additionally, in the EU, the European Parliament and the European Council reached an agreement in December 2025 on the EU Pharma Package the largest reform of the EU s Pharmaceutical Legislation in 20 years.
• The reform still requires formal approval by both institutions and will enter into force upon publication in the EU s Official Journal, expected in 2026.
• Most provisions are expected to apply from 2028, following a two-year transition period.
• This landmark reform is expected to significantly influence the way innovative medicines are developed, authorized, monitored, and accessed across the EU.
• In addition, the European Regulation on Health Technology Assessment (EU HTA-R) took effect in January 2025, introducing a single EU-level submission file for joint clinical assessments for oncology medicines and advanced therapy medicinal products.
• The EU HTA-R will be extended to orphan medicines in January 2028 and, as of 2030, will cover all medicinal products authorized in the EU through the centralized marketing authorization procedure.
• Major U.S. healthcare reform occurred with the passage of the OBBBA on July 4, 2025, a budget reconciliation bill that includes significant funding cuts to Medicaid, the Health Insurance Marketplaces, and the Medicare Physician Fee Schedule.
• The Congressional Budget Office (CBO) estimates the OBBBA will reduce federal healthcare spending and lead to a 10 million increase in the U.S. uninsured population, all of which could lead to increased pricing controls and lower demand for our products.
• Further, the evolving vaccine landscape is becoming more challenging and increases risks to Pfizer.
• Among other things, risks include changing regulatory requirements, including for potential development or approval of our vaccine candidates, government investigations, changes in legislation, policy, liability landscape or other administrative actions, changes, delays or failure to receive recommendations, reimbursement, regulatory approvals and coverage for our vaccines, restrictions on pharmaceutical advertising and changes to government agencies and advisory boards.
• For example, in January 2026, the CDC unilaterally reduced the number of immunizations routinely recommended for all children in the U.S.
• We expect additional drug cost containment efforts at both the federal and state levels, as evidenced by the MFN Initiatives and the December 2025 issue by HHS of proposed rules for mandatory CMMI pilots which could require additional price concessions.
• Regulatory decisions or feedback could impact the future development of our product candidates, including our vaccine candidates such as our next generation pneumococcal conjugate vaccine candidate.
• We may experience increasing inconsistencies and unexpected changes in the evaluations and determinations made by the FDA during the process of applying for marketing approvals of our products due to reductions in workforce, personnel movements, and policy changes.
• In addition, administrative decisions relating to our products or product candidates may not follow the expected process.
• For example, as discussed above, in January 2026 the CDC unilaterally reduced the number of immunizations routinely recommended for all children in the U.S.
• Following a comprehensive process, in October 2025, the EMA adopted a negative opinion on benefit-risk for Oxbryta for the treatment of hemolytic anemia due to SCD, recommending that the marketing authorization for the product remain suspended.
• In the U.S., Pfizer s engagement with the FDA is ongoing.
• Potential expansion of our mRNA portfolio could result in an increase in patent-related disputes as well.

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Removed words are struck through; added words are highlighted.

• If known or unknown risks or uncertainties materialize, our business operations, financial condition, operating results (including components of our financial results), cash flows, prospects, reputation or credit ratings could be materially adversely affected now and in the future, potentially in a material way. future.
• The negotiating power of MCOs, PBMs and other private third-party payors has increased due to consolidation, and they, along with state and federal governments, increasingly employ formularies tools to control costs and encourage utilization of certain drugs, including through the use of deductibles, utilization management tools, cost sharing or formulary placement.
• They may demand rebates and/or fees from biopharmaceutical manufacturers for preferred placement formulary placement, or for unrestricted access on a drug formulary.
• The growing availability and use of higher cost higher-cost innovative specialty pharmaceutical medicines that treat rare or life threatening life-threatening conditions also has generated also increased payor interest in the development deployment of cost-containment strategies.
• We may fail to obtain or maintain timely or adequate pricing or formulary placement of our products, or fail to obtain such formulary placement at favorable pricing net that reflects the value of rebates. the treatment.
• Third-party payors also use additional measures such as new-to-market blocks, exclusion lists, carve-outs or indication-based pricing and value-based pricing/contracting to improve their cost containment efforts and cost efficiency.
• As the U.S. private third-party payor market consolidates further, and as the IRA prices become publicly available, we may face greater pricing pressure from private third-party payors payors, including insurers and PBMs, as they continue to drive more of their patients to use lower cost alternatives or seek even larger rebates to control costs or offset losses from the IRA. IRA and other market pressures.
• For additional information on the IRA, IRA see the Item 1.
• Also, business arrangements in this area are subject to a high degree of government scrutiny, and available exceptions and safe harbors under applicable federal and state fraud and abuse laws are subject to change through legislative and regulatory action, as well as evolving judicial interpretations.
• Some of our competitors may have competitive, technical or other advantages over us for the development of technologies and processes or greater experience in particular therapeutic areas, and technological innovation and/or consolidation among certain pharmaceutical and biotechnology companies can enhance such advantages.
• Our products and product candidates compete, and may compete in the future, against products or product candidates that offer higher rebates or discounts, exclusionary contracting, lower prices, equivalent or superior efficacy, efficacy and/or coverage, better safety or tolerability profiles, easier administration, earlier market availability or other competitive features, including greater brand recognition or potential preference to prescribe existing competitor treatments over our novel therapies.
• Pfizer Inc. 2024 Form 10-K 15 In addition, competition from manufacturers of generic drugs, including from generic versions of competitors branded products that lose their market exclusivity, is a major challenge for our branded products.
• We anticipate a more significant impact reduction of reduced revenues revenue from patent-based or regulatory exclusivity expiries in 2026 through 2030 as several of our in-line products experience these expirations.
• Business Patents and Other Intellectual Property Rights Pfizer Inc. 2025 Form 10-K 16 section.
• CONCENTRATION We recorded revenues of more than $1 billion for each of 11 12 products that collectively accounted for 66% 65% of Total revenues in 2024. 2025.
• For example, Eliquis accounted for 12% 13% of Total revenues in 2024. 2025.
• See Notes N otes 1 and 17 .
• If these products or any of our other major products were to, or continue to (if applicable), experience loss of patent protection (if applicable), changes in prescription or vaccination purchasing or growth rates, reduced product demand, material product liability litigation, unexpected side effects or safety concerns, regulatory proceedings or investigations, lower governmental and/or regulatory confidence, negative publicity affecting doctor or patient confidence, pressure from competitive products, changes in recommendations and coverage, changes in labeling, pricing and access pressures, including those related to the IRA, IRA and MFN, or supply shortages or if a new, more effective product should be introduced, the adverse impact on our revenues could be significant and our revenue forecasts and expectations could prove to be inaccurate and we may fail to meet these expectations.
• In particular, certain of our products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few years, and we expect certain products to face new or increased generic competition over the next few years.
• While additional patent-based or regulatory exclusivity expiries will continue, we expect a moderate impact of reduced revenues due to patent expiries in 2025 and We anticipate a more significant impact reduction of reduced revenues revenue from patent-based or regulatory exclusivity expiries in 2026 through 2030 as several of our in-line products experience these expirations. expirations, with the rate of the reduction of revenues from patent-based or regulatory exclusivity expiries expected to significantly accelerate over the next few years.
• Our product lines must be replenished over time to offset revenue losses when products lose exclusivity or market share or to respond to healthcare and innovation trends, as well as to provide for earnings growth, primarily through internal R&D or through collaborations, acquisitions, JVs, licensing or other arrangements. arrangements, including co-funding agreements with third-parties .
• Further, even if we identify areas with the greatest commercial potential, the scientific approach may not succeed despite the significant investment required for R&D, and the product may not be as competitive as expected because of of, among other things, the highly dynamic regulatory and market environments environments, the competitive landscape and the hurdles in terms of access, coverage and reimbursement.
• Pfizer Inc. 2024 2025 Form 10-K 16 17 GLOBAL OPERATIONS We operate on a global scale and could be affected by currency and interest rate fluctuations; global trade tensions; capital and exchange controls; local and global economic conditions including inflation, recession, volatility and/or lack of liquidity in capital markets; expropriation and other restrictive government actions; changes in intellectual property; legal protections and remedies; trade regulations; tariffs; tax laws and regulations; and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to our products, as well as impacts of political or civil unrest or military action, including including, without limitation, the ongoing conflicts between Russia and Ukraine and in the Middle East and their economic consequences, geopolitical instability, terrorist activity, unstable governments and legal systems, inter-governmental disputes, public health outbreaks, epidemics, pandemics, natural disasters or disruptions related to climate change.
• In addition, issued or future executive orders orders, or other new or changes in laws, regulations or policy regarding tariffs, tariffs or other trade or foreign policy, could have a material adverse effect on our business, earnings earnings, cash flow, liquidity and financial guidance.
• The actual impact of the any new tariffs on our business is would be 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.
• In 2024, 39% 2025, 41% of our total revenues were derived from international operations, including 19% 21% from Europe and 13% 12% from China, Japan and the rest of the Asia Pacific region.
• For example, i n 2021, Pfizer recalled all lots of Chantix due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the acceptable intake limits communicated by various regulatory authorities.
• Pfizer Inc. 2025 Form 10-K 18 COLLABORATIONS AND OTHER RELATIONSHIPS WITH THIRD PARTIES We depend on third-party collaborators, service providers, and others in the research, development, manufacturing and commercialization of our products and product candidates and also enter into JVs and other business development transactions.
• We also outsource certain services, including activities related to transaction processing, accounting, IT, manufacturing, clinical trial recruitment and execution, clinical lab services, non-clinical research, safety services, integrated facilities Pfizer Inc. 2024 Form 10-K 17 management and other areas.
• The prevalence of counterfeit medicines is an industry-wide issue due to a variety of factors, including the adoption of e-commerce. e-commerce and the proliferation of heavily marketed compounded medicines.
• Counterfeiters generally target any medicine or vaccine boasting strong demand and we have observed heightened counterfeit and fraud attempts to our internal medicine portfolio, our oncology portfolio, as well as products utilized in the treatment of COVID-19. COVID-19 and competitor products in therapeutic areas where we are conducting R&D.
• RISKS RELATED TO GOVERNMENT REGULATION AND LEGAL PROCEEDINGS: PRICING AND REIMBURSEMENT Our future results could be adversely affected by new or changes in U.S. and international governmental regulations that mandate price controls, use international reference pricing, including MFN, increase required rebates, establish mandatory CMMI pilots (which are models designed to test certain payment and delivery systems to determine whether they result in cost savings), create coverage criteria, or limit patient access to our products.
• In addition to the expansion of price controls in the U.S. in the IRA, or through a CMMI demonstration program affecting Medicare or Medicaid, the adoption of more restrictive coverage policies and price controls in new and existing jurisdictions, or the failure to obtain or maintain coverage and pricing could also adversely impact revenue.
• In the U.S., pharmaceutical product pricing is subject to government and public scrutiny and calls for reform, and and, as a result, many of our products are subject to increasing pricing pressures as a result. pressures.
• For example, Additionally, the drug pricing provisions of the IRA are being implemented over the next several years.
• The drug pricing provisions of the IRA began to be implemented in 2022 and implementation efforts will continue in the coming years.
• In August 2024, the government released the new Medicare price for Eliquis, which will become became effective January 1, 2026.
• On In January 17, 2025, CMS announced the selection of another 15 drugs from Medicare Part D for the maximum fair price, Maximum Fair Price, with prices to be set and effective on January 1, 2027.
• Another 15 drugs from Pfizer Inc. 2025 Form 10-K 19 Medicare Part B or Medicare Part D will be were selected by February 1, on January 27, 2026, for the maximum price Maximum Fair Price to be set and in effect by effective on January 1, 2028.
• It is possible that more of our products could be selected in future years, which could, among other things, lead to lower revenues prior to expiry of intellectual property protections. revenues.

Removed since the previous 10-K 21

• These initiatives have increased consumers interest in drug prices and input in medication choices, as they pay for a larger portion of their prescription costs and may cause them to favor lower-cost generic alternatives.
• For Comirnaty and Paxlovid, while we believe that these products have the potential to provide ongoing stable revenue streams for Pfizer for the foreseeable future, revenues of these products have decreased substantially over time.
• If nitrosamines are detected above certain levels in our products, this may lead to market action for such products.
• Regulatory authorities have since issued updated guidance on nitrosamine acceptable intake levels.
• With this guidance, which included an updated intake level for N-nitroso-varenicline, we have started making regulatory submissions to potentially enable Chantix to return to market in the U.S. and in certain international markets.
• Additionally, in the EU, the EC proposed the largest reform of EU pharmaceutical legislation in 20 years.
• In April 2024, the European Parliament introduced amendments to the EC s proposal.
• The EU legislative process remains ongoing, with several stages still required before the reform can receive final approval.
• This reform may alter Pfizer Inc. 2024 Form 10-K 18 regulatory exclusivity periods for our products and may add burdensome obligations that impact access.
• In addition, with the European Regulation on Health Technology Assessment (EU HTA-R) taking effect in January 2025, we are engaging and monitoring application of the EU s new clinical assessment program to new oncology products and certain biologic products submitted to the EMA.
• We expect additional drug cost containment efforts at both the federal and state levels.
• The terms of our EUA for Comirnaty require that we conduct post-observational studies to evaluate the association between the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent), Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), and a pre-specified list of adverse events of special interest, including myocarditis and pericarditis, along with deaths and hospitalizations, and severe COVID-19.
• The required study populations include individuals specified in our September 2023 authorization letter (reissued) as well as populations of interest, such as healthcare workers, pregnant women, immunocompromised individuals and subpopulations with specific comorbidities.
• Additionally, in relation to the FDA approval for Comirnaty, we are required to complete certain post marketing study requirements and commitments through 2024 and beyond.
• In connection with the resolution of a U.S. government investigation concerning independent copay assistance organizations that provide financial assistance to Medicare patients, in 2018, we entered into a Corporate Integrity Agreement with the Office of the Inspector General of the HHS (OIG), which expired in May 2023.
• Pfizer submitted its final annual report in October 2023 and the OIG officially closed the matter in January 2025.
• For example, the WTO s June 2022 Ministerial Decision on the Agreement on Trade-Related Aspects of Intellectual Property Rights seeks to make it easier for certain WTO members to issue a compulsory license on COVID-19 vaccines.
• As we expand our mRNA portfolio, patent-related disputes may increase.
• For example, our manufacturing facility in Rocky Mount, NC was damaged by a tornado in July 2023.
• For additional details on the impact of the tornado in Rocky Mount, NC, see the Overview of Our Performance, Operating Environment, Strategy and Outlook Our Operating Environment section within MD&A.
• While we monitor a broad range of corporate responsibility matters, we cannot be certain that we will manage such matters successfully, or that we will successfully meet the expectations of investors, employees, consumers, governments and other stakeholders.

Source: SEC EDGAR filings, compared sentence by sentence by EdgarStack. Sentence matching is automated and may pair or split passages imperfectly; check the linked filings before relying on any passage. A software tool, not financial advice. Not affiliated with the U.S. Securities and Exchange Commission.