PFIZER INC (PFE) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that PFIZER INC surfaced in its latest filing.

• Pfizer signed voluntary agreements with the Trump Administration designed to ensure U.S. patients pay lower prices for prescription medicines.
• Pfizer anticipates a significant reduction of revenue from patent-based or regulatory exclusivity expiries in 2026 through 2030, with the rate of reduction expected to significantly accelerate.
• Eliquis accounted for 13% of Total revenues in 2025.2025
• Acquisitions of Metsera and Seagen represent significant investments in obesity and oncology, respectively, which are extremely competitive therapeutic areas.
• In 2025, 41% of total revenues were derived from international operations, including 21% from Europe and 12% from China, Japan, and the rest of the Asia Pacific region.2025
• In September 2025, Pfizer entered into a voluntary agreement with the Trump Administration, receiving a three-year grace period during which Pfizer products will not face Section 232 tariffs, provided further investment in manufacturing in the U.S.September 2025
• Conflicts between Russia and Ukraine and in the Middle East and their economic consequences.
• Voluntary withdrawal of all lots of Oxbryta in all markets where it is approved.
• Recalled Chantix in 2021 due to presence of N-nitroso-varenicline at or above acceptable intake limits.2021
• Chantix returned to market in 2025 in the U.S. and certain international markets after updated guidance.2025
• May and July 2025 Trump Administration MFN Initiatives.May and July 2025
• September 2025 MFN Agreement with Trump Administration to make certain U.S. drug prices comparable to other developed countries.September 2025
• Participation in TrumpRx.gov platform offering certain medicines at discounts to retail prices.
• IRA directs HHS to set prices for certain high-expenditure single-source drugs and biologics under Medicare.
• IRA imposes inflation-based rebates under Medicare Part B and Part D.
• IRA replaces Medicare Part D coverage gap discount program with a new discounting program.
• August 2023 CMS selection of Eliquis among first ten medicines subject to MDPNP.August 2023
• August 2024 government release of new Medicare price for Eliquis effective January 1, 2026.August 2024
• January 2025 CMS selection of Ibrance and Xtandi for Maximum Fair Price effective January 1, 2027.January 2025
• January 2026 selection of Xeljanz for Maximum Fair Price effective January 1, 2028.January 2026
• QCE and VBP tender process in China resulted in significant price cuts for off-patent medicines.
• EU Pharma Package agreed December 2025, largest reform of EU pharmaceutical legislation in 20 years, expected to apply from 2028.December 2025
• EU HTA-R took effect January 2025 with single EU-level submission for joint clinical assessments.January 2025
• EU HTA-R extended to orphan medicines in January 2028 and all centralized medicines by 2030.January 2028
• The OBBBA passed July 4, 2025 includes significant funding cuts to Medicaid, Health Insurance Marketplaces, and Medicare Physician Fee Schedule.July 4, 2025
• CBO estimates OBBBA will reduce federal healthcare spending and lead to a 10 million increase in U.S. uninsured population.
• In January 2026, the CDC unilaterally reduced the number of immunizations routinely recommended for all children in the U.S.January 2026
• December 2025 HHS proposed rules for mandatory CMMI pilots which could require additional price concessions.December 2025
• In September 2024, the decision was made to voluntarily withdraw Oxbryta in all markets where it was approved.September 2024
• In October 2025, the EMA adopted a negative opinion on benefit-risk for Oxbryta for treatment of hemolytic anemia due to SCD, recommending the marketing authorization for the product remain suspended.October 2025
• In the U.S., Pfizer’s engagement with the FDA regarding Oxbryta is ongoing.
• Pfizer established its fourth consecutive GHG reduction goal in June 2022 with near- and long-term targets to achieve the Science Based Target Initiative's voluntary Net-Zero Standard by 2040.June 2022