\n| \n 2025\u00a0<\/b><\/p>\n<\/td>\n | \n 2024\u00a0<\/b><\/p>\n<\/td>\n | \n Change<\/b><\/p>\n<\/td>\n | \n Change Ex-Exchange<\/b><\/p>\n<\/td>\n | \n Dec. 31, 2025<\/b><\/p>\n<\/td>\n | \n Dec. 31, 2024<\/b><\/p>\n<\/td>\n | \n Change<\/b><\/p>\n<\/td>\n | \n Change Ex-Exchange<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n \nSales<\/p>\n<\/td>\n | \n \n$16,400\u00a0<\/p>\n<\/td>\n | \n \n$15,624\u00a0<\/p>\n<\/td>\n | \n \n5%\u00a0<\/p>\n<\/td>\n | \n \n4%\u00a0<\/p>\n<\/td>\n | \n \n$65,011\u00a0<\/p>\n<\/td>\n | \n \n$64,168\u00a0<\/p>\n<\/td>\n | \n \n1%\u00a0<\/p>\n<\/td>\n | \n \n2%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nGAAP net income1<\/sup><\/p>\n<\/td>\n| \n \n2,963\u00a0<\/p>\n<\/td>\n | \n \n3,743\u00a0<\/p>\n<\/td>\n | \n \n-21%\u00a0<\/p>\n<\/td>\n | \n \n-20%\u00a0<\/p>\n<\/td>\n | \n \n18,254\u00a0<\/p>\n<\/td>\n | \n \n17,117\u00a0<\/p>\n<\/td>\n | \n \n7%\u00a0<\/p>\n<\/td>\n | \n \n9%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nNon-GAAP net income that excludes certain items1,2*<\/sup><\/p>\n<\/td>\n| \n \n5,088\u00a0<\/p>\n<\/td>\n | \n \n4,372\u00a0<\/p>\n<\/td>\n | \n \n16%\u00a0<\/p>\n<\/td>\n | \n \n17%\u00a0<\/p>\n<\/td>\n | \n \n22,513\u00a0<\/p>\n<\/td>\n | \n \n19,444\u00a0<\/p>\n<\/td>\n | \n \n16%\u00a0<\/p>\n<\/td>\n | \n \n18%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nGAAP EPS<\/p>\n<\/td>\n | \n \n1.19\u00a0<\/p>\n<\/td>\n | \n \n1.48\u00a0<\/p>\n<\/td>\n | \n \n-20%\u00a0<\/p>\n<\/td>\n | \n \n-18%\u00a0<\/p>\n<\/td>\n | \n \n7.28\u00a0<\/p>\n<\/td>\n | \n \n6.74\u00a0<\/p>\n<\/td>\n | \n \n8%\u00a0<\/p>\n<\/td>\n | \n \n10%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nNon-GAAP EPS that excludes certain items2*<\/sup><\/p>\n<\/td>\n| \n \n2.04\u00a0<\/p>\n<\/td>\n | \n \n1.72\u00a0<\/p>\n<\/td>\n | \n \n19%\u00a0<\/p>\n<\/td>\n | \n \n19%\u00a0<\/p>\n<\/td>\n | \n \n8.98\u00a0<\/p>\n<\/td>\n | \n \n7.65\u00a0<\/p>\n<\/td>\n | \n \n17%\u00a0<\/p>\n<\/td>\n | \n \n19%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \n*Refer to table on page 9.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \nGenerally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.19 for the fourth quarter and $7.28 for the full year of 2025. Non-GAAP EPS was $2.04 for the fourth quarter and $8.98 for the full year of 2025. GAAP and non-GAAP EPS in the fourth quarter of 2025 include a charge of $0.05 per share related to an agreement with Dr. Falk Pharma GmbH (Falk) pursuant to which the Company secured the sole global rights to MK-8690. GAAP and non-GAAP EPS in the fourth quarter of 2024 include a charge of $0.23 per share related to the execution of licensing agreements with LaNova Medicines Ltd. (acquired by Sino Pharmaceutical Limited) and Hansoh Pharma. GAAP and non-GAAP EPS for the full years of 2025 and 2024 include charges of $0.20 and $1.28 per share, respectively, related to certain licensing agreements and asset acquisitions.<\/p>\n \nNon-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in 2025 also excludes a net tax benefit, which reflects a net benefit related to favorable audit reserve adjustments. Non-GAAP EPS in the fourth quarter and full year of 2024 also exclude a benefit due to a reduction in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years.<\/p>\n Fourth-Quarter Sales Performance<\/span><\/b><\/p>\n\nThe following table reflects sales of the Company\u2019s top products and significant performance drivers.<\/p>\n \n\n| \n \n\u00a0<\/p>\n<\/td>\n | \n Fourth Quarter<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n \n$ in millions<\/p>\n<\/td>\n | \n 2025\u00a0<\/b><\/p>\n<\/td>\n | \n 2024\u00a0<\/b><\/p>\n<\/td>\n | \n Change<\/b><\/p>\n<\/td>\n | \n Change Ex-Exchange<\/b><\/p>\n<\/td>\n | \n Commentary<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n \nTotal Sales<\/p>\n<\/td>\n | \n \n$16,400\u00a0<\/p>\n<\/td>\n | \n \n$15,624\u00a0<\/p>\n<\/td>\n | \n \n5%\u00a0<\/p>\n<\/td>\n | \n \n4%\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nPharmaceutical<\/p>\n<\/td>\n | \n \n14,843\u00a0<\/p>\n<\/td>\n | \n \n14,042\u00a0<\/p>\n<\/td>\n | \n \n6%\u00a0<\/p>\n<\/td>\n | \n \n4%\u00a0<\/p>\n<\/td>\n | \n \nIncrease primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by a decline in vaccines.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nKEYTRUDA\/ KEYTRUDA QLEX<\/p>\n<\/td>\n | \n \n8,372\u00a0<\/p>\n<\/td>\n | \n \n7,836\u00a0<\/p>\n<\/td>\n | \n \n7%\u00a0<\/p>\n<\/td>\n | \n \n5%\u00a0<\/p>\n<\/td>\n | \n \nGrowth driven by strong global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), renal cell carcinoma, cervical and head and neck cancers, as well as continued global demand in metastatic indications, including urothelial, gastric and endometrial cancers. Sales growth was partially offset by timing of purchases in the U.S. Sales of KEYTRUDA QLEX were $35 million.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nGARDASIL\/
\n
GARDASIL 9<\/p>\n<\/td>\n | \n \n1,031\u00a0<\/p>\n<\/td>\n | \n \n1,550\u00a0<\/p>\n<\/td>\n | \n \n-34%\u00a0<\/p>\n<\/td>\n | \n \n-35%\u00a0<\/p>\n<\/td>\n | \n \nDecline primarily due to lower demand in China, as well as lower sales in Japan following the national catch-up immunization program, partially offset by higher sales in the U.S. and timing in certain international markets.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nPROQUAD, M-M-R II and VARIVAX<\/p>\n<\/td>\n | \n \n619\u00a0<\/p>\n<\/td>\n | \n \n594\u00a0<\/p>\n<\/td>\n | \n \n4%\u00a0<\/p>\n<\/td>\n | \n \n3%\u00a0<\/p>\n<\/td>\n | \n \nIncrease primarily reflects higher sales of PROQUAD, which largely resulted from both the replenishment of doses borrowed from the U.S. Centers for Disease Control and Prevention Pediatric Vaccine Stockpile and from higher demand in Europe, partially offset by lower demand for M-M-R II in certain international markets and lower demand for VARIVAX in the U.S.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nJANUVIA\/JANUMET<\/p>\n<\/td>\n | \n \n501\u00a0<\/p>\n<\/td>\n | \n \n487\u00a0<\/p>\n<\/td>\n | \n \n3%\u00a0<\/p>\n<\/td>\n | \n \n3%\u00a0<\/p>\n<\/td>\n | \n \nGrowth driven by higher net pricing in the U.S., partially offset by lower demand in China as well as in most other international markets due to generic competition.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nBRIDION<\/p>\n<\/td>\n | \n \n499\u00a0<\/p>\n<\/td>\n | \n \n449\u00a0<\/p>\n<\/td>\n | \n \n11%\u00a0<\/p>\n<\/td>\n | \n \n11%\u00a0<\/p>\n<\/td>\n | \n \nGrowth primarily due to higher demand and net pricing in the U.S., partially offset by lower demand in several international markets due to ongoing generic competition.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nWINREVAIR<\/p>\n<\/td>\n | \n \n467\u00a0<\/p>\n<\/td>\n | \n \n200\u00a0<\/p>\n<\/td>\n | \n \n133%\u00a0<\/p>\n<\/td>\n | \n \n133%\u00a0<\/p>\n<\/td>\n | \n \nGrowth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, partially offset by lower net pricing in the U.S. largely due to Medicare Part D redesign.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nLynparza*<\/p>\n<\/td>\n | \n \n389\u00a0<\/p>\n<\/td>\n | \n \n365\u00a0<\/p>\n<\/td>\n | \n \n7%\u00a0<\/p>\n<\/td>\n | \n \n4%\u00a0<\/p>\n<\/td>\n | \n \nGrowth primarily due to higher demand in several international markets.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nCAPVAXIVE<\/p>\n<\/td>\n | \n \n279\u00a0<\/p>\n<\/td>\n | \n \n50\u00a0<\/p>\n<\/td>\n | \n \nN\/M<\/p>\n<\/td>\n | \n \nN\/M\u00a0<\/p>\n<\/td>\n | \n \nGrowth largely due to continued uptake in the U.S.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nPREVYMIS<\/p>\n<\/td>\n | \n \n275\u00a0<\/p>\n<\/td>\n | \n \n215\u00a0<\/p>\n<\/td>\n | \n \n28%\u00a0<\/p>\n<\/td>\n | \n \n26%\u00a0<\/p>\n<\/td>\n | \n \nIncrease primarily due to higher demand in the U.S. as well as in most international markets, reflecting in part the launch of new indications.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nLenvima*<\/p>\n<\/td>\n | \n \n272\u00a0<\/p>\n<\/td>\n | \n \n255\u00a0<\/p>\n<\/td>\n | \n \n7%\u00a0<\/p>\n<\/td>\n | \n \n6%\u00a0<\/p>\n<\/td>\n | \n \nIncrease due to higher sales in the U.S., primarily reflecting higher demand, partially offset by lower pricing.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nWELIREG<\/p>\n<\/td>\n | \n \n220\u00a0<\/p>\n<\/td>\n | \n \n160\u00a0<\/p>\n<\/td>\n | \n \n37%\u00a0<\/p>\n<\/td>\n | \n \n37%\u00a0<\/p>\n<\/td>\n | \n \nGrowth primarily due to higher demand in the U.S. and continued launch uptake in several international markets, partially offset by lower net pricing in the U.S.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nOHTUVAYRE<\/p>\n<\/td>\n | \n \n178\u00a0<\/p>\n<\/td>\n | \n \n–\u00a0<\/p>\n<\/td>\n | \n \n–\u00a0<\/p>\n<\/td>\n | \n \n–\u00a0<\/p>\n<\/td>\n | \n \nRepresents sales following the Company’s Oct. 7, 2025 acquisition of Verona Pharma plc (Verona Pharma).<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nAnimal Health<\/p>\n<\/td>\n | \n \n1,505\u00a0<\/p>\n<\/td>\n | \n \n1,397\u00a0<\/p>\n<\/td>\n | \n \n8%\u00a0<\/p>\n<\/td>\n | \n \n6%\u00a0<\/p>\n<\/td>\n | \n \nGrowth primarily due to higher demand of livestock products.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nLivestock<\/p>\n<\/td>\n | \n \n987\u00a0<\/p>\n<\/td>\n | \n \n889\u00a0<\/p>\n<\/td>\n | \n \n11%\u00a0<\/p>\n<\/td>\n | \n \n9%\u00a0<\/p>\n<\/td>\n | \n \nGrowth primarily driven by higher demand across all species, as well as improved supply and new product launches.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nCompanion Animal<\/p>\n<\/td>\n | \n \n518\u00a0<\/p>\n<\/td>\n | \n \n508\u00a0<\/p>\n<\/td>\n | \n \n2%\u00a0<\/p>\n<\/td>\n | \n \n0%\u00a0<\/p>\n<\/td>\n | \n \nGrowth from new product launches was partially offset by lower demand for other products in portfolio, reflecting a reduction in veterinary visits. Sales of BRAVECTO line of products were $222 million and $209 million in current and prior-year quarters, respectively, which represents an increase of 6%, or 5% excluding impact of foreign exchange.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nOther Revenues**<\/p>\n<\/td>\n | \n \n52\u00a0<\/p>\n<\/td>\n | \n \n185\u00a0<\/p>\n<\/td>\n | \n \n-71%\u00a0<\/p>\n<\/td>\n | \n \n-15%\u00a0<\/p>\n<\/td>\n | \n \nDecline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\n| \n \n*Alliance revenue for this product represents the Company\u2019s share of profits, which are product sales net of cost of sales and commercialization costs.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \n**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nN\/M – Not meaningful.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n Full-Year Sales Performance<\/span><\/b><\/p>\n\nThe following table reflects sales of the Company\u2019s top products and significant performance drivers.<\/p>\n \n\n| \n \n\u00a0<\/p>\n<\/td>\n | \n Year Ended<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n \n$ in millions<\/p>\n<\/td>\n | \n Dec. 31, 2025<\/b><\/p>\n<\/td>\n | \n Dec. 31, 2024<\/b><\/p>\n<\/td>\n | \n Change<\/b><\/p>\n<\/td>\n | \n Change Ex-Exchange<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n \nTotal Sales<\/p>\n<\/td>\n | \n \n$65,011\u00a0<\/p>\n<\/td>\n | \n \n$64,168\u00a0<\/p>\n<\/td>\n | \n \n1%\u00a0<\/p>\n<\/td>\n | \n \n2%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nPharmaceutical<\/p>\n<\/td>\n | \n \n58,142\u00a0<\/p>\n<\/td>\n | \n \n57,400\u00a0<\/p>\n<\/td>\n | \n \n1%\u00a0<\/p>\n<\/td>\n | \n \n1%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nKEYTRUDA\/KEYTRUDA QLEX<\/p>\n<\/td>\n | \n \n31,680\u00a0<\/p>\n<\/td>\n | \n \n29,482\u00a0<\/p>\n<\/td>\n | \n \n7%\u00a0<\/p>\n<\/td>\n | \n \n7%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nGARDASIL\/GARDASIL 9<\/p>\n<\/td>\n | \n \n5,233\u00a0<\/p>\n<\/td>\n | \n \n8,583\u00a0<\/p>\n<\/td>\n | \n \n-39%\u00a0<\/p>\n<\/td>\n | \n \n-39%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nJANUVIA\/JANUMET<\/p>\n<\/td>\n | \n \n2,544\u00a0<\/p>\n<\/td>\n | \n \n2,268\u00a0<\/p>\n<\/td>\n | \n \n12%\u00a0<\/p>\n<\/td>\n | \n \n13%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nPROQUAD, M-M-R II and VARIVAX<\/p>\n<\/td>\n | \n \n2,451\u00a0<\/p>\n<\/td>\n | \n \n2,485\u00a0<\/p>\n<\/td>\n | \n \n-1%\u00a0<\/p>\n<\/td>\n | \n \n-2%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nBRIDION<\/p>\n<\/td>\n | \n \n1,841\u00a0<\/p>\n<\/td>\n | \n \n1,764\u00a0<\/p>\n<\/td>\n | \n \n4%\u00a0<\/p>\n<\/td>\n | \n \n4%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nLynparza*<\/p>\n<\/td>\n | \n \n1,450\u00a0<\/p>\n<\/td>\n | \n \n1,311\u00a0<\/p>\n<\/td>\n | \n \n11%\u00a0<\/p>\n<\/td>\n | \n \n10%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nWINREVAIR<\/p>\n<\/td>\n | \n \n1,443\u00a0<\/p>\n<\/td>\n | \n \n419\u00a0<\/p>\n<\/td>\n | \n \nN\/M\u00a0<\/p>\n<\/td>\n | \n \nN\/M\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nLenvima*<\/p>\n<\/td>\n | \n \n1,053\u00a0<\/p>\n<\/td>\n | \n \n1,010\u00a0<\/p>\n<\/td>\n | \n \n4%\u00a0<\/p>\n<\/td>\n | \n \n4%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nPREVYMIS<\/p>\n<\/td>\n | \n \n978\u00a0<\/p>\n<\/td>\n | \n \n785\u00a0<\/p>\n<\/td>\n | \n \n25%\u00a0<\/p>\n<\/td>\n | \n \n23%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nVAXNEUVANCE<\/p>\n<\/td>\n | \n \n825\u00a0<\/p>\n<\/td>\n | \n \n808\u00a0<\/p>\n<\/td>\n | \n \n2%\u00a0<\/p>\n<\/td>\n | \n \n1%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nCAPVAXIVE<\/p>\n<\/td>\n | \n \n759\u00a0<\/p>\n<\/td>\n | \n \n97\u00a0<\/p>\n<\/td>\n | \n \nN\/M\u00a0<\/p>\n<\/td>\n | \n \nN\/M\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nWELIREG<\/p>\n<\/td>\n | \n \n716\u00a0<\/p>\n<\/td>\n | \n \n509\u00a0<\/p>\n<\/td>\n | \n \n41%\u00a0<\/p>\n<\/td>\n | \n \n41%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nROTATEQ<\/p>\n<\/td>\n | \n \n673\u00a0<\/p>\n<\/td>\n | \n \n711\u00a0<\/p>\n<\/td>\n | \n \n-5%\u00a0<\/p>\n<\/td>\n | \n \n-5%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nReblozyl*<\/p>\n<\/td>\n | \n \n525\u00a0<\/p>\n<\/td>\n | \n \n371\u00a0<\/p>\n<\/td>\n | \n \n41%\u00a0<\/p>\n<\/td>\n | \n \n41%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nLAGEVRIO<\/p>\n<\/td>\n | \n \n380\u00a0<\/p>\n<\/td>\n | \n \n964\u00a0<\/p>\n<\/td>\n | \n \n-61%\u00a0<\/p>\n<\/td>\n | \n \n-61%<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nSimponi**<\/p>\n<\/td>\n | \n \n–\u00a0<\/p>\n<\/td>\n | \n \n543\u00a0<\/p>\n<\/td>\n | \n \n-100%\u00a0<\/p>\n<\/td>\n | \n \n-100%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nAnimal Health<\/p>\n<\/td>\n | \n \n6,354\u00a0<\/p>\n<\/td>\n | \n \n5,877\u00a0<\/p>\n<\/td>\n | \n \n8%\u00a0<\/p>\n<\/td>\n | \n \n9%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nLivestock<\/p>\n<\/td>\n | \n \n3,896\u00a0<\/p>\n<\/td>\n | \n \n3,462\u00a0<\/p>\n<\/td>\n | \n \n13%\u00a0<\/p>\n<\/td>\n | \n \n14%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nCompanion Animal<\/p>\n<\/td>\n | \n \n2,458\u00a0<\/p>\n<\/td>\n | \n \n2,415\u00a0<\/p>\n<\/td>\n | \n \n2%\u00a0<\/p>\n<\/td>\n | \n \n2%\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nOther Revenues***<\/p>\n<\/td>\n | \n \n515\u00a0<\/p>\n<\/td>\n | \n \n891\u00a0<\/p>\n<\/td>\n | \n \n-42%\u00a0<\/p>\n<\/td>\n | \n \n-6%\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\n| \n \n*Alliance revenue for Lynparza and Lenvima represent the Company\u2019s share of profits, which are product sales net of cost of sales and commercialization costs. Alliance revenue for Reblozyl represents royalties.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \n**Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \n***Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nN\/M – Not meaningful.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \nIn addition, Koselugo alliance revenue was $436 million for the full year of 2025 compared with $170 million for the full year of 2024. The increase was due to an amendment to the collaboration agreement with AstraZeneca in 2025, which discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure, resulting in the Company\u2019s recognition of a $150 million upfront payment and $175 million of regulatory milestones.<\/p>\n \nFull-year 2025 Pharmaceutical sales were $58.1 billion, representing growth of 1% both nominally and excluding the impact of foreign exchange. Sales growth was primarily driven by higher sales in oncology, particularly KEYTRUDA and WELIREG, as well as increased alliance revenue from Koselugo (resulting from the amendment to the collaboration agreement noted above), Reblozyl and Lynparza. Also contributing to sales growth were higher sales in the cardiometabolic and respiratory franchise largely attributable to the ongoing launch of WINREVAIR, as well as the inclusion of OHTUVAYRE sales resulting from the acquisition of Verona Pharma, which closed on Oct. 7, 2025. Growth in the diabetes franchise, largely attributable to higher net pricing of JANUVIA in the U.S., also contributed to sales growth. Sales growth in 2025 was partially offset by lower sales in the vaccines franchise reflecting lower sales of GARDASIL\/GARDASIL 9, which were offset in part by the ongoing launch of CAPVAXIVE and the U.S. launch of ENFLONSIA. Lower sales in the immunology franchise (due to the return of the marketing rights for Simponi and Remicade in former Company territories to Johnson & Johnson on Oct. 1, 2024) and lower sales in the virology franchise (largely attributable to LAGEVRIO) also offset Pharmaceutical sales growth in 2025.<\/p>\n \nFull-year 2025 Animal Health sales were $6.4 billion, representing growth of 8%, or 9% excluding the impact of foreign exchange. Sales growth was primarily driven by the performance of Livestock products across all species and new product launches in Companion Animal. Sales of the BRAVECTO line of products were $1.1 billion in 2025, representing growth of 1% both nominally and excluding the impact of foreign exchange.<\/p>\n Fourth-Quarter and Full-Year Expense and Related Information<\/span><\/b><\/p>\n\nThe table below presents selected expense information.<\/p>\n \n\n| \n \n$ in millions<\/p>\n<\/td>\n | \n GAAP<\/b><\/p>\n<\/td>\n | \n Acquisition-
\n
and
\n
Divestiture-
\n
Related Costs3<\/sup><\/b><\/p>\n<\/td>\n\n Restructuring
\n
Costs<\/b><\/p>\n<\/td>\n | \n (Income)
\n
Loss From
\n
Investments
\n
in Equity
\n
Securities<\/b><\/p>\n<\/td>\n | \n Non-
\n
GAAP2<\/sup><\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n Fourth Quarter 2025<\/b><\/p>\n<\/td>\n | | \n | \n | \n | \n | <\/tr>\n \n| \n \nCost of sales<\/p>\n<\/td>\n | \n \n$5,551<\/p>\n<\/td>\n | \n \n$1,054<\/p>\n<\/td>\n | \n \n$1,173<\/p>\n<\/td>\n | \n \n$-<\/p>\n<\/td>\n | \n \n$3,324<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nSelling, general and administrative<\/p>\n<\/td>\n | \n \n2,898<\/p>\n<\/td>\n | \n \n48<\/p>\n<\/td>\n | \n \n2<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n2,848<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nResearch and development<\/p>\n<\/td>\n | \n \n3,886<\/p>\n<\/td>\n | \n \n5<\/p>\n<\/td>\n | \n \n(111)<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n3,992<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nRestructuring costs<\/p>\n<\/td>\n | \n \n213<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n213<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nOther (income) expense, net<\/p>\n<\/td>\n | \n \n432<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n206<\/p>\n<\/td>\n | \n \n226<\/p>\n<\/td>\n<\/tr>\n | \n| \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n Fourth Quarter 2024<\/b><\/p>\n<\/td>\n | | \n\n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nCost of sales<\/p>\n<\/td>\n | \n \n$3,828<\/p>\n<\/td>\n | \n \n$701<\/p>\n<\/td>\n | \n \n$121<\/p>\n<\/td>\n | \n \n$-<\/p>\n<\/td>\n | \n \n$3,006<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nSelling, general and administrative<\/p>\n<\/td>\n | \n \n2,864<\/p>\n<\/td>\n | \n \n29<\/p>\n<\/td>\n | \n \n16<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n2,819<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nResearch and development<\/p>\n<\/td>\n | \n \n4,585<\/p>\n<\/td>\n | \n \n12<\/p>\n<\/td>\n | \n \n(1)<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n4,574<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nRestructuring costs<\/p>\n<\/td>\n | \n \n51<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n51<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nOther (income) expense, net<\/p>\n<\/td>\n | \n \n126<\/p>\n<\/td>\n | \n \n(31)<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n152<\/p>\n<\/td>\n | \n \n5<\/p>\n<\/td>\n<\/tr>\n<\/table>\n \n\n| \n \n$ in millions<\/p>\n<\/td>\n | \n GAAP<\/b><\/p>\n<\/td>\n | \n Acquisition-
\n
and
\n
Divestiture-
\n
Related Costs3<\/sup><\/b><\/p>\n<\/td>\n\n Restructuring
\n
Costs<\/b><\/p>\n<\/td>\n | \n (Income)
\n
Loss From
\n
Investments
\n
in Equity
\n
Securities<\/b><\/p>\n<\/td>\n | \n Non-
\n
GAAP2<\/sup><\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n Year Ended Dec. 31, 2025<\/b><\/p>\n<\/td>\n | | \n | \n | \n | \n | <\/tr>\n \n| \n \nCost of sales<\/p>\n<\/td>\n | \n \n$16,382<\/p>\n<\/td>\n | \n \n$2,871<\/p>\n<\/td>\n | \n \n$1,484<\/p>\n<\/td>\n | \n \n$-<\/p>\n<\/td>\n | \n \n$12,027<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nSelling, general and administrative<\/p>\n<\/td>\n | \n \n10,733<\/p>\n<\/td>\n | \n \n120<\/p>\n<\/td>\n | \n \n3<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n10,610<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nResearch and development<\/p>\n<\/td>\n | \n \n15,789<\/p>\n<\/td>\n | \n \n19<\/p>\n<\/td>\n | \n \n175<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n15,595<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nRestructuring costs<\/p>\n<\/td>\n | \n \n889<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n889<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nOther (income) expense, net<\/p>\n<\/td>\n | \n \n151<\/p>\n<\/td>\n | \n \n(3)<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n(306)<\/p>\n<\/td>\n | \n \n460<\/p>\n<\/td>\n<\/tr>\n | \n| \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n Year Ended Dec. 31, 2024<\/b><\/p>\n<\/td>\n | | \n\n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nCost of sales<\/p>\n<\/td>\n | \n \n$15,193<\/p>\n<\/td>\n | \n \n$2,409<\/p>\n<\/td>\n | \n \n$495<\/p>\n<\/td>\n | \n \n$-<\/p>\n<\/td>\n | \n \n$12,289<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nSelling, general and administrative<\/p>\n<\/td>\n | \n \n10,816<\/p>\n<\/td>\n | \n \n117<\/p>\n<\/td>\n | \n \n83<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n10,616<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nResearch and development<\/p>\n<\/td>\n | \n \n17,938<\/p>\n<\/td>\n | \n \n72<\/p>\n<\/td>\n | \n \n1<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n17,865<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nRestructuring costs<\/p>\n<\/td>\n | \n \n309<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n309<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nOther (income) expense, net<\/p>\n<\/td>\n | \n \n(24)<\/p>\n<\/td>\n | \n \n(79)<\/p>\n<\/td>\n | \n \n–<\/p>\n<\/td>\n | \n \n45<\/p>\n<\/td>\n | \n \n10<\/p>\n<\/td>\n<\/tr>\n<\/table>\n GAAP Expense, EPS and Related Information<\/span><\/b><\/p>\n\nGross margin was 66.2% for the fourth quarter of 2025 compared with 75.5% for the fourth quarter of 2024. Gross margin was 74.8% for the full year of 2025 compared with 76.3% for the full year of 2024. The gross margin decline in both periods was primarily due to the unfavorable impacts of higher restructuring costs (primarily related to the accelerated depreciation of manufacturing lines at two sites under the 2025 Restructuring Program), inventory write-offs and amortization of intangible assets, as well as the recognition of inventory fair value step-up related to the Verona Pharma acquisition, partially offset by the favorable impact of product mix.<\/p>\n \nSelling, general and administrative (SG&A) expenses were $2.9 billion in the fourth quarter of 2025, an increase of 1% compared with the fourth quarter of 2024. The increase was primarily due to higher administrative costs, partially offset by lower promotional costs. Full-year 2025 SG&A expenses were $10.7 billion, a decrease of 1% compared with the full year of 2024. The decrease was primarily due to lower restructuring and promotional costs, partially offset by increased administrative costs.<\/p>\n \nResearch and development (R&D) expenses were $3.9 billion in the fourth quarter of 2025, a decrease of 15% compared with the fourth quarter of 2024. The decrease was primarily due to lower charges for business development activity and a reduction to estimated contractual termination costs associated with restructuring actions, partially offset by higher clinical development costs. R&D expenses were $15.8 billion for the full year of 2025, a decrease of 12% compared with the full year of 2024. The decrease was primarily due to lower charges for business development activity, partially offset by higher clinical development spending and higher restructuring costs.<\/p>\n \nOther (income) expense, net, was $432 million of expense in the fourth quarter of 2025 compared with $126 million of expense in the fourth quarter of 2024 primarily due to higher net interest expense, higher foreign exchange losses and increased net losses from investments in equity securities. Other (income) expense, net, was $151 million of expense in the full year of 2025 compared with $24 million of income in the full year of 2024. The unfavorable year-over-year change primarily reflects $170 million of income in 2024 related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as higher net interest expense and higher foreign exchange losses in 2025, partially offset by higher net income from investments in equity securities in 2025.<\/p>\n \nThe effective tax rate was 13.4% for the fourth quarter of 2025 and 13.3% for the full year of 2025.<\/p>\n \nGAAP EPS was $1.19 for the fourth quarter of 2025 compared with $1.48 for the fourth quarter of 2024. The decrease was primarily driven by higher restructuring costs and amortization of intangible assets, partially offset by favorability from lower charges for business development transactions, as well as operational strength in the business driven in part by the benefits of the previously announced multiyear optimization initiative. GAAP EPS was $7.28 for the full year of 2025 compared with $6.74 for the full year of 2024. The increase was primarily driven by favorability from lower charges for business development transactions and operational strength in the business, partially offset by higher restructuring costs and amortization of intangible assets.<\/p>\n Non-GAAP Expense, EPS and Related Information<\/span><\/b><\/p>\n\nNon-GAAP gross margin was 79.7% for the fourth quarter of 2025 compared with 80.8% for the fourth quarter of 2024. The decrease was primarily due to higher inventory write-offs, partially offset by the favorable impact of product mix. Non-GAAP gross margin was 81.5% for the full year of 2025 compared with 80.8% for the full year of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by higher inventory write-offs.<\/p>\n \nNon-GAAP SG&A expenses were $2.8 billion in the fourth quarter of 2025, an increase of 1% compared with the fourth quarter of 2024. The increase was primarily due to higher administrative costs, partially offset by lower promotional costs. Non-GAAP SG&A expenses were $10.6 billion for the full year of 2025, flat compared with the full year of 2024 as lower promotional costs were largely offset by higher administrative costs.<\/p>\n \nNon-GAAP R&D expenses were $4.0 billion in the fourth quarter of 2025, a decrease of 13% compared with the fourth quarter of 2024. Non-GAAP R&D expenses were $15.6 billion for the full year of 2025, a decrease of 13% compared with the full year of 2024. The decrease in both periods was primarily due to lower charges for business development activity, partially offset by higher clinical development costs.<\/p>\n \nNon-GAAP other (income) expense, net, was $226 million of expense in the fourth quarter of 2025 compared with $5 million of expense in the fourth quarter of 2024 primarily due to higher net interest expense and higher foreign exchange losses. Non-GAAP other (income) expense, net, was $460 million of expense in the full year of 2025 compared with $10 million of expense in the full year of 2024. The unfavorable year-over-year change primarily reflects $170 million of income in 2024 related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as higher net interest expense and higher foreign exchange losses in 2025.<\/p>\n \nThe non-GAAP effective tax rate was 15.4% for the fourth quarter of 2025 and 14.4% for the full year of 2025.<\/p>\n \nNon-GAAP EPS was $2.04 for the fourth quarter of 2025 compared with $1.72 for the fourth quarter of 2024. Non-GAAP EPS was $8.98 for the full year of 2025 compared with $7.65 for the full year of 2024. The increase in both periods was primarily driven by favorability from lower charges for business development transactions, as well as operational strength in the business driven in part by the benefits of the previously announced multiyear optimization initiative.<\/p>\n \nA reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.<\/p>\n \n\n | \n\n Fourth Quarter<\/b><\/p>\n<\/td>\n | \n Year Ended<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n \n$ in millions, except EPS amounts<\/p>\n<\/td>\n | \n 2025<\/b><\/p>\n<\/td>\n | \n 2024<\/b><\/p>\n<\/td>\n | \n Dec. 31, 2025<\/b><\/p>\n<\/td>\n | \n Dec. 31, 2024<\/b><\/p>\n<\/td>\n<\/tr>\n\n| \n EPS<\/b><\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nGAAP EPS<\/p>\n<\/td>\n | \n \n$1.19<\/p>\n<\/td>\n | \n \n$1.48<\/p>\n<\/td>\n | \n \n$7.28<\/p>\n<\/td>\n | \n \n$6.74<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nDifference<\/p>\n<\/td>\n | \n \n0.85<\/p>\n<\/td>\n | \n \n0.24<\/p>\n<\/td>\n | \n \n1.70<\/p>\n<\/td>\n | \n \n0.91<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nNon-GAAP EPS that excludes items listed below2<\/sup><\/p>\n<\/td>\n| \n \n$2.04<\/p>\n<\/td>\n | \n \n$1.72<\/p>\n<\/td>\n | \n \n$8.98<\/p>\n<\/td>\n | \n \n$7.65<\/p>\n<\/td>\n<\/tr>\n | \n| \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n Net Income<\/b><\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nGAAP net income1<\/sup><\/p>\n<\/td>\n| \n \n$2,963<\/p>\n<\/td>\n | \n \n$3,743<\/p>\n<\/td>\n | \n \n$18,254<\/p>\n<\/td>\n | \n \n$17,117<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nDifference<\/p>\n<\/td>\n | \n \n2,125<\/p>\n<\/td>\n | \n \n629<\/p>\n<\/td>\n | \n \n4,259<\/p>\n<\/td>\n | \n \n2,327<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nNon-GAAP net income that excludes items listed below1,2<\/sup><\/p>\n<\/td>\n| \n \n$5,088<\/p>\n<\/td>\n | \n \n$4,372<\/p>\n<\/td>\n | \n \n$22,513<\/p>\n<\/td>\n | \n \n$19,444<\/p>\n<\/td>\n<\/tr>\n | \n| \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n Excluded Items:<\/b><\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n | \n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nAcquisition- and divestiture-related costs3<\/sup><\/p>\n<\/td>\n| \n \n$1,107<\/p>\n<\/td>\n | \n \n$711<\/p>\n<\/td>\n | \n \n$3,007<\/p>\n<\/td>\n | \n \n$2,519<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nRestructuring costs<\/p>\n<\/td>\n | \n \n1,277<\/p>\n<\/td>\n | \n \n187<\/p>\n<\/td>\n | \n \n2,551<\/p>\n<\/td>\n | \n \n888<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nLoss (income) from investments in equity securities<\/p>\n<\/td>\n | \n \n206<\/p>\n<\/td>\n | \n \n152<\/p>\n<\/td>\n | \n \n(306)<\/p>\n<\/td>\n | \n \n45<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nDecrease to net income before taxes<\/p>\n<\/td>\n | \n \n2,590<\/p>\n<\/td>\n | \n \n1,050<\/p>\n<\/td>\n | \n \n5,252<\/p>\n<\/td>\n | \n \n3,452<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nEstimated income tax (benefit) expense4<\/sup><\/p>\n<\/td>\n| \n \n(465)<\/p>\n<\/td>\n | \n \n(421)<\/p>\n<\/td>\n | \n \n(993)<\/p>\n<\/td>\n | \n \n(1,125)<\/p>\n<\/td>\n<\/tr>\n | \n| \n \nDecrease to net income<\/p>\n<\/td>\n | \n \n$2,125<\/p>\n<\/td>\n | \n \n$629<\/p>\n<\/td>\n | \n \n$4,259<\/p>\n<\/td>\n | \n \n$2,327<\/p>\n<\/td>\n<\/tr>\n<\/table>\n Pipeline and Portfolio Highlights<\/span><\/b><\/p>\n\nIn 2025, the Company announced positive late-stage trial results from 18 Phase 3 trials and began enrolling patients in 21 new Phase 3 studies evaluating multiple indications and therapeutic areas, with approximately 80 Phase 3 studies currently underway.<\/p>\n \nThroughout the fourth quarter, the Company made important progress to advance its broad, diverse pipeline, meeting significant regulatory and clinical milestones.<\/p>\n \n- \nOncology:<\/p>\n
\n- \nU.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, for the perioperative treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy based on Phase 3 KEYNOTE-905 trial.<\/p>\n
\n- \nApprovals represent the first PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens for this patient population.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nFDA awarded a priority review voucher under the Commissioner\u2019s National Priority Voucher (CNPV) pilot program for sac-TMT, an investigational anti-TROP2 ADC being developed in collaboration with Kelun-Biotech.<\/p>\n<\/li>\n
- \nEuropean Commission (EC) approved the subcutaneous route of administration and new pharmaceutical formulation of KEYTRUDA for use across all KEYTRUDA indications for adult patients in Europe.<\/p>\n<\/li>\n
- \nFDA accepted two supplemental Biologics License Applications (sBLAs) for KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of certain patients with PD-L1+ inoperable (unresectable) locally advanced or metastatic TNBC based on Phase 3 KEYNOTE-D19\/ASCENT-04 trial.<\/p>\n
\n- \nFDA set Prescription Drug User Fee Act (PDUFA) dates in the second half of 2026 for these applications.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nAnnounced positive topline results from Phase 3 KEYNOTE-B15 trial in patients with MIBC who are eligible for cisplatin-based chemotherapy showing KEYTRUDA plus Padcev significantly improved event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates versus neoadjuvant chemotherapy and surgery when given before and after surgery.<\/p>\n<\/li>\n
- \nIn collaboration with Moderna, Inc. (Moderna), announced median five-year follow-up data from Phase 2b KEYNOTE-942\/mRNA-4157-P201 study for intismeran autogene, an investigational mRNA-based individualized neoantigen therapy, in combination with KEYTRUDA in patients with high-risk melanoma (stage III\/IV) following complete resection.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nInfectious Diseases:<\/p>\n
\n- \nAnnounced positive topline results from the Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine\/islatravir (DOR\/ISL) for the treatment of adults with HIV-1 infection who had not previously received antiretroviral treatment (treatment-na\u00efve).<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nCardiometabolic and Respiratory:<\/p>\n
\n- \nPresented new data at the American Heart Association Scientific Sessions 2025, including results from the Phase 3 CORALreef Lipids and heterozygous familial hypercholesterolemia (HeFH) trials, demonstrating that enlicitide decanoate, an investigational, oral proprotein convertase subtilisin\/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hypercholesterolemia, significantly reduced low-density lipoprotein cholesterol (LDL-C) with a safety profile comparable to placebo.<\/p>\n
\n- \nFDA awarded a priority review voucher under the CNPV pilot program for enlicitide decanoate.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nIn January 2026, EC approved an expanded indication for WINREVAIR, in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH (Group 1 pulmonary hypertension) in adult patients with World Health Organization (WHO) Functional Class II, III and IV based on Phase 3 ZENITH trial.<\/p>\n<\/li>\n
- \nIn February 2026, FDA accepted a new sBLA for WINREVAIR seeking approval to update the U.S. product label based on Phase 3 HYPERION trial.<\/p>\n
\n- \nFDA set PDUFA date of September 21, 2026.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nAnnounced that Phase 2, proof-of-concept CADENCE study evaluating WINREVAIR in adults for the treatment of combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF) met its primary endpoint.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n
- \nBusiness Development:<\/p>\n
\n- \nIn 2026, completed acquisition of Cidara Therapeutics, Inc. (Cidara) for a total transaction value of approximately $9.2 billion.<\/p>\n
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