Pneumococcal 15-valent Conjugate Vaccine(Merck & Co.)

Sales Growth Driven by Continued Strength in Oncology and Animal Health, Plus Increasing Contributions From Launches Total Worldwide Sales Were $16.3 Billion (5% Growth; 3% Growth ex-FX) KEYTRUDA/KEYTRUDA QLEX 1 Sales Were $8.0 Billion (12% Growth; 8% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $128 Million WINREVAIR Sales Were $525 Million (88% Growth; 87% Growth ex-FX) Animal Health Sales Were $1.8 Billion (13% Growth; 6% Growth ex-FX) GAAP Loss per Share Was $1.72; Non-GAAP Loss per Share Was $1.28; GAAP and Non-GAAP Loss per Share Include a Charge of $3.62 per Share for the Acquisition of Cidara Presented New Data From Cardio-Pulmonary Pipeline at ACC.26, Including Positive Results From Phase 3 CORALreef AddOn Trial Received U.S. FDA Approval for IDVYNSO, a Once-Daily, Oral Treatment for Certain Adults With Virologically Suppressed HIV-1 Achieved Multiple Significant Regulatory and Clinical Milestones Across Oncology Pipeline Announced Agreement To Acquire Terns Pharmaceuticals, Inc. and Expand Hematology Pipeline With TERN-701, a Novel Candidate for Chronic Myeloid Leukemia; Transaction Expected To Close in May Full-Year 2026 Financial Outlook Narrows and Raises the Midpoint of Worldwide Sales Range; Now Expects Sales To Be Between $65.8 Billion and $67.0 Billion Narrows and Raises Expected Non-GAAP EPS Range To Be Between $5.04 and $5.16 Outlook Does Not Reflect Any Impact From Proposed Acquisition of Terns Pharmaceuticals, Inc., Which Is Expected To Close in May and Result in a One-Time Charge of Approximately $5.8 Billion or Approximately $2.35 per Share RAHWAY, N.J.--(BUSINESS WIRE)--Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2026. “We are moving with speed to transform our portfolio to one with a diversified set of growth drivers across a broad set of therapeutic areas,” said Robert M. Davis, chairman and chief executive officer. “During the first quarter, we continued to strengthen our pipeline with science-led business development, including our planned acquisition of Terns. We also achieved several important milestones, such as the FDA approval of IDVYNSO – which marks a new chapter in our longstanding commitment to people living with HIV. I am pleased with our progress and excited for what’s ahead, as we enter a particularly robust period of Phase 3 data readouts and deliver on the promise of our pipeline for patients.” Financial Summary $ in millions, except EPS amounts First Quarter 2026 2025 Change Change Ex- Exchange Sales $16,286 $15,529 5% 3% GAAP net (loss) income 2 (4,240) 5,079 N/M N/M Non-GAAP net (loss) income that excludes certain items 2,3* (3,156) 5,611 N/M N/M GAAP EPS (1.72) 2.01 N/M N/M Non-GAAP EPS that excludes certain items 3* (1.28) 2.22 N/M N/M *Refer to table on page 7. N/M - Not meaningful. For the first quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $1.72 and non-GAAP loss per share was $1.28. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Cidara Therapeutics, Inc. (Cidara) of $3.62 per share. Non-GAAP EPS excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as income and losses from investments in equity securities. First-Quarter Sales Performance The following table reflects sales of the Company’s top products and significant performance drivers. First Quarter $ in millions 2026 2025 Change Change Ex- Exchange Commentary Total Sales $16,286 $15,529 5% 3% Pharmaceutical 14,349 13,638 5% 2% Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by declines in vaccines, diabetes and infectious diseases. KEYTRUDA/ KEYTRUDA QLEX 8,034 7,205 12% 8% Growth primarily driven by higher global demand in metastatic indications including urothelial cancer, as well as strong global uptake in earlier-stage indications, including triple-negative breast cancer, cervical cancer and renal cell carcinoma (RCC). Sales growth benefited from the timing of wholesaler purchases in the U.S. Sales of KEYTRUDA QLEX were $128 million. GARDASIL/ GARDASIL 9 1,069 1,327 -19% -22% Decline primarily due to lower demand in China as well as lower sales in Japan following the national catch-up immunization program. Decline also reflects lower sales in the U.S. primarily due to unfavorable public-sector purchasing patterns, partially offset by higher net pricing. JANUVIA/JANUMET 574 796 -28% -29% Decline primarily due to lower demand and net pricing in the U.S., as well as lower demand in China and most other international markets due to generic competition. PROQUAD, M-M-R II and VARIVAX 538 539 0% -2% Sales were flat, primarily driven by unfavorable private sector purchasing patterns for M-M-R II and lower demand for M-M-R II and VARIVAX in the U.S., offset by higher PROQUAD sales in the U.S. due to borrowing of doses in 2025 from a U.S. government stockpile, which lowered sales in that period. WINREVAIR 525 280 88% 87% Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe. BRIDION 472 441 7% 7% Growth primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition. Lynparza* 341 312 9% 6% Growth primarily due to higher demand in the U.S. and many international markets. PREVYMIS 272 208 31% 26% Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications. Lenvima* 256 258 -1% -2% Relatively flat compared with prior year. ROTATEQ 206 228 -10% -11% Decrease primarily driven by lower demand in China. VAXNEUVANCE 202 230 -12% -16% Decrease primarily driven by lower demand in the U.S. and most international markets due to competitive pressure. WELIREG 199 137 45% 43% Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan and certain European markets. CAPVAXIVE 142 107 33% 31% Increase primarily driven by launch uptake in certain European markets and continued uptake in the U.S. U.S. sales growth was partially offset by a reduction in wholesaler inventory. OHTUVAYRE 131 - - - Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc (Verona Pharma). LAGEVRIO 28 102 -73% -73% Decline largely due to lower demand in Japan and the U.S. Animal Health 1,791 1,588 13% 6% Growth attributable to performance in both Livestock and Companion Animal product portfolios. Livestock 1,064 924 15% 8% Growth primarily driven by higher demand for ruminant and poultry products as well as price. Companion Animal 727 664 9% 4% Growth from new product launches and price was partially offset by lower demand for other products in portfolio, reflecting a reduction in veterinary visits. Sales of BRAVECTO line of products were $379 million and $327 million in current and prior-year quarters, respectively, which represents an increase of 16%, or 9% excluding impact of foreign exchange. Other Revenues** 146 303 -52% 4% Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements, partially offset by higher milestones received for out-licensing arrangements and higher royalty income. *Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. **Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. In addition, Koselugo alliance revenue was $161 million for the first quarter of 2026 compared with $44 million for the first quarter of 2025. The increase was due to a $150 million payment received in the first quarter of 2026 in connection with an amendment to the collaboration agreement with AstraZeneca in 2025, which (subject to an annual election by AstraZeneca) discontinued the provisions whereby the Company shared revenue and costs with AstraZeneca, and revised the payment structure. First-Quarter Expense and Related Information The table below presents selected expense information. $ in millions GAAP Acquisition- and Divestiture- Related Costs 4 Restructuring Costs (Income) Loss From Investments in Equity Securities Non- GAAP 3 First Quarter 2026 Cost of sales $4,195 $1,014 $237 $ - $2,944 Selling, general and administrative 2,700 32 - - 2,668 Research and development 12,592 - 34 - 12,558 Restructuring costs 195 - 195 - - Other (income) expense, net 138 - - (180) 318 First Quarter 2025 Cost of sales $3,419 $620 $36 $- $2,763 Selling, general and administrative 2,552 23 - - 2,529 Research and development 3,621 7 - - 3,614 Restructuring costs 69 - 69 - - Other (income) expense, net (35) (3) - (107) 75 GAAP Expense, EPS and Related Information Gross margin was 74.2% for the first quarter of 2026 compared with 78.0% for the first quarter of 2025. The decrease was primarily due to higher amortization of intangible assets, higher restructuring costs, the recognition of inventory fair value step-up related to the 2025 Verona Pharma acquisition and the unfavorable impact of foreign exchange, partially offset by favorable product mix. Selling, general and administrative (SG&A) expenses were $2.7 billion in the first quarter of 2026, an increase of 6% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange. Research and development (R&D) expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending, the unfavorable impact of foreign exchange and restructuring costs, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone Life Sciences (Blackstone) and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBiotech Limited (EyeBio). Other (income) expense, net, was $138 million of expense in the first quarter of 2026 compared with $35 million of income in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities. The income tax provision for the first quarter of 2026 was $709 million on a pretax loss of $3.5 billion, resulting in an effective income tax rate of (20.1)%. This effective income tax rate includes a 33.1 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded. GAAP loss per share was $1.72 for the first quarter of 2026 compared with earnings per share of $2.01 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara. Non-GAAP Expense, EPS and Related Information Non-GAAP gross margin was 81.9% for the first quarter of 2026 compared with 82.2% for the first quarter of 2025. The decrease was primarily due to the unfavorable impact of foreign exchange, partially offset by favorable product mix. Non-GAAP SG&A expenses were $2.7 billion in the first quarter of 2026, an increase of 5% compared with the first quarter of 2025. The increase was primarily due to higher administrative costs and the unfavorable impact of foreign exchange. Non-GAAP R&D expenses were $12.6 billion in the first quarter of 2026 compared with $3.6 billion in the first quarter of 2025. The increase was primarily due to a $9.0 billion charge for the acquisition of Cidara, higher clinical development spending and the unfavorable impact of foreign exchange, partially offset by a $200 million reduction in R&D expenses as part of the funding agreement with Blackstone and a $100 million charge in the first quarter of 2025 for the achievement of a developmental milestone related to the 2024 acquisition of EyeBio. Non-GAAP other (income) expense, net, was $318 million of expense in the first quarter of 2026 compared with $75 million of expense in the first quarter of 2025. The unfavorability was primarily due to higher net interest expense. The non-GAAP income tax provision for the first quarter of 2026 was $957 million on a pretax loss of $2.2 billion, resulting in a non-GAAP effective income tax rate of (43.5)%. This effective income tax rate includes a 57.6 percentage point unfavorable impact of the charge for the acquisition of Cidara, for which no tax benefit was recorded. Non-GAAP loss per share was $1.28 for the first quarter of 2026 compared with earnings per share of $2.22 for the first quarter of 2025, primarily driven by a $3.62 per share charge included in the first quarter of 2026 for the acquisition of Cidara. A reconciliation of GAAP to non-GAAP net (loss) income and EPS is provided in the table that follows. First Quarter $ in millions, except EPS amounts 2026 2025 EPS GAAP EPS $(1.72) $2.01 Difference 0.44 0.21 Non-GAAP EPS that excludes items listed below 3 $(1.28) $2.22 Net (Loss) Income GAAP net (loss) income 2 $(4,240) $5,079 Difference 1,084 532 Non-GAAP net (loss) income that excludes items listed below 2,3 $(3,156) $5,611 Excluded Items: Acquisition- and divestiture-related costs 4 $1,046 $647 Restructuring costs 466 105 Income from investments in equity securities (180) (107) Increase to net loss / decrease to net income before taxes 1,332 645 Estimated income tax benefit 5 (248) (113) Increase to net loss / decrease to net income $1,084 $532 Pipeline and Portfolio Highlights In the first quarter, the Company continued to advance its pipeline, achieving significant regulatory and clinical milestones across a broad range of therapeutic areas. Oncology: U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX plus paclitaxel, with or without bevacizumab, for the treatment of certain adults with PD-L1+ (combined positive score [CPS] ≥1) platinum-resistant ovarian cancer, based on Phase 3 KEYNOTE-B96 trial. The European Commission (EC) also approved this KEYTRUDA regimen for this population. In April, FDA approved a label update for KEYTRUDA QLEX based on results from Phase 2 MK-3475A-F11 trial, which evaluated patient-reported preference for subcutaneous administration of KEYTRUDA QLEX over intravenous administration of KEYTRUDA in participants with multiple tumor types. In April, FDA granted priority review for ifinatamab deruxtecan (I-DXd) for certain adults with previously treated extensive-stage small cell lung cancer, based on Phase 2 Ideate-Lung01 trial. I-DXd is part of the Company’s collaboration with Daiichi Sankyo. FDA set Prescription Drug User Fee Act (PDUFA) date of Oct. 10, 2026. FDA accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX for the adjuvant treatment of certain patients with RCC, based on the Phase 3 LITESPARK-022 trial. FDA set PDUFA date of June 19, 2026. FDA accepted supplemental applications for WELIREG plus Lenvima in certain previously treated patients with advanced RCC, based on the Phase 3 LITESPARK-011 trial. Lenvima is being developed as part of a collaboration with Eisai Co., Ltd (Eisai). FDA set PDUFA date of Oct. 4, 2026. Announced positive results from Phase 3 KEYNOTE-B15 trial (also known as EV-304) demonstrating KEYTRUDA plus Padcev reduced the risk of event-free survival (EFS) events by 47% and reduced the risk of death by 35% in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC) when given before and after surgery. KEYNOTE-B15 is the sixth study demonstrating overall survival (OS) with a KEYTRUDA-based regimen in an earlier-stage cancer. In April, FDA granted priority review for KEYTRUDA and KEYTRUDA QLEX, each with Padcev, for cisplatin-eligible patients with MIBC, based on the Phase 3 KEYNOTE-B15 trial. FDA set PDUFA date of Aug. 17, 2026. In a pre-specified interim analysis of the Phase 3 LITESPARK-012 study, compared to KEYTRUDA plus Lenvima, the triplet combination therapy of KEYTRUDA plus Lenvima plus WELIREG, as well as the combination of MK-1308A (an investigational fixed dose coformulation of KEYTRUDA and the anti-CTLA-4 antibody quavonlimab) plus Lenvima, did not show a statistically significant improvement in the primary endpoints of progression-free survival and OS in patients with advanced clear cell RCC. In the Phase 3 KEYNOTE-975 study, compared to placebo plus definitive chemoradiotherapy (dCRT), KEYTRUDA plus dCRT did not show a statistically significant improvement in the primary endpoint of EFS in certain patients with locally advanced unresectable esophageal carcinoma. In a prespecified interim analysis of the Phase 3 KEYNOTE-866 study, compared to perioperative placebo plus neoadjuvant chemotherapy, perioperative KEYTRUDA plus neoadjuvant chemotherapy did not show a statistically significant improvement in the primary endpoint of EFS in patients with cisplatin-eligible MIBC who underwent radical cystectomy and pelvic lymph node dissection. Vaccines and Infectious Diseases: In April, FDA approved once-daily IDVYNSO, an oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for the treatment of certain adults with virologically suppressed HIV-1, based on Phase 3 MK-8591A-051 and MK-8591A-052 trials. IDVYNSO was also approved in Japan for these patients in March. Presented data from three Phase 3 trials evaluating DOR/ISL at the 33 rd Conference on Retroviruses and Opportunistic Infections (CROI), including: Results from Phase 3 MK-8591A-053 trial demonstrated that DOR/ISL is the first two-drug regimen that does not include an integrase strand transfer inhibitor to demonstrate non-inferiority and similar safety pro Week 48 versus bictegravir/emtricitabine/tenofovir alafenamide 6 [(50 mg/200 mg/25 mg) (BIC/FTC/TAF)] in adults living with HIV-1 who had not previously received antiretroviral treatment. Results from the Phase 3 MK-8591A-052 and MK-8591A-051 trials demonstrated that DOR/ISL maintained virologic suppression at Week 96 in adults with virologically suppressed HIV-1 who switched from other antiretroviral therapies, including BIC/FTC/TAF. In April, EC approved ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season, based on Phase 2b/3 CLEVER and Phase 3 SMART trials. Announced positive second RSV season results from Phase 3 SMART trial evaluating the safety, efficacy and pharmacokinetics of ENFLONSIA in infants and children at increased risk for severe RSV disease over two RSV seasons. European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinion for an expanded indication for CAPVAXIVE for active immunization against invasive pneumococcal disease and pneumococcal pneumonia in certain children and adolescents at increased risk of pneumococcal disease. Cardiometabolic and Respiratory: Presented new data at the American College of Cardiology’s Annual Scientific Session and Expo (ACC.26) including: Positive results from Phase 3 CORALreef AddOn trial demonstrated significantly greater LDL-C reductions at eight weeks compared to guideline-recommended oral non-statin therapies when added to background statins. This is the third positive Phase 3 study of enlicitide. Positive data from Phase 2 CADENCE trial provided definitive proof-of-concept for WINREVAIR in adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF). Totality of evidence supports advancing development of WINREVAIR for this distinct patient population into a registrational Phase 3 study. Animal Health: FDA approved NUMELVI for dogs, the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older. Business Development: Announced an agreement to acquire Terns Pharmaceuticals, Inc. (Terns) through a subsidiary. Expands hematology pipeline with the addition of TERN-701, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor currently in Phase 1/2 development for certain patients with chronic myeloid leukemia (CML). Transaction expected to close in May. Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.* Oncology KEYTRUDA and KEYTRUDA QLEX, Plus Paclitaxel ± Bevacizumab, FDA Approved for Certain Adults With PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma as Second- or Third-Line Treatment; Based on Results From Phase 3 KEYNOTE-B96 Trial EC Approved KEYTRUDA Plus Paclitaxel ± Bevacizumab for Treatment of Adults With PD-L1 (CPS ≥1) Platinum-Resistant Recurrent Ovarian Carcinoma Who Have Received One or Two Prior Systemic Treatment Regimens; Based on Results From Phase 3 KEYNOTE-B96 Trial I-DXd Granted Priority Review in U.S. for Adult Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer Who Experienced Disease Progression on or After Platinum-Based Chemotherapy; Based on Results From Phase 2 Ideate-Lung01 Trial; FDA Set PDUFA Date of Oct. 10, 2026 FDA Granted Priority Review for KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, for Cisplatin-Eligible Patients With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial; FDA Set PDUFA Date of Aug. 17, 2026 KEYTRUDA Plus Padcev Reduced Risk of EFS Events by 47% and Risk of Death by 35% for Cisplatin-Eligible Patients With MIBC When Given Before and After Surgery; Results From Phase 3 KEYNOTE-B15 Trial KEYTRUDA Plus Paclitaxel With or Without Bevacizumab Significantly Improved Key Secondary Endpoint of OS Versus Paclitaxel With or Without Bevacizumab in Patients With Platinum-Resistant Recurrent Ovarian Cancer; Results From Phase 3 KEYNOTE-B96 Trial KEYTRUDA Plus WELIREG Given as Adjuvant Therapy Reduced Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Patients With Earlier-Stage RCC; Results From Phase 3 LITESPARK-022 Trial; FDA Set PDUFA Date of June 19, 2026 for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX WELIREG Plus Lenvima Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With RCC; Results From Phase 3 LITESPARK-011 Trial; FDA Set PDUFA Date of Oct. 4, 2026 The Company and Eisai Provided Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced RCC Vaccines and Infectious Diseases FDA Approved the Company’s Once-Daily IDVYNSO for Adults With Virologically Suppressed HIV-1; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials The Company Announced Late-Breaking Data From Three Phase 3 Trials Evaluating DOR/ISL, an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults Living With HIV-1, at CROI 2026 EC Approved ENFLONSIA for the Prevention of RSV Lower Respiratory Tract Disease in Infants During Their First RSV Season; Based on Results From Phase 2b/3 CLEVER and Phase 3 SMART Trials The Company Announced Positive New Data for ENFLONSIA for Infants and Children Under 2 Years of Age at Increased Risk for Severe RSV Disease Over Two RSV Seasons; Results From Phase 3 SMART Trial The Company Presented New Data Reinforcing Long-Term Efficacy of GARDASIL 9 and GARDASIL at the EUROGIN International Multidisciplinary HPV Congress 2026 Cardiometabolic and Respiratory Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background Statins; Results From Phase 3 CORALreef AddOn Trial Positive Data From Phase 2 CADENCE Trial Provided Definitive Proof-of-Concept for WINREVAIR in Adults With the Syndrome of CpcPH-HFpEF Ophthalmology The Company Initiated Pivotal Phase 2b/3 Trial Evaluating MK-8748, an Investigational Bispecific Tie2 Agonist/VEGF Inhibitor, for the Treatment of Neovascular Age-Related Macular Degeneration Animal Health FDA Approved NUMELVI for Dogs – First and Only Second-Generation JAK Inhibitor for the Control of Pruritus Associated With Allergic Dermatitis Research The Company and Mayo Clinic Announced New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine The Company and Google Cloud Partnered To Accelerate Agentic AI Enterprise Transformation *References to the Company’s name in the above news release titles have been modified for the purpose of this announcement. Contacts Media Contacts: Michael Levey michael.levey@msd.com John Cummins john.cummins2@msd.com Investor Contacts: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583 Read full story here

Fourth-Quarter Worldwide Sales Were $16.4 Billion (5% Growth; 4% Growth ex-FX) Fourth-Quarter GAAP EPS Was $1.19; Non-GAAP EPS Was $2.04; GAAP and Non-GAAP EPS Include a Charge of $0.05 per Share for the Acquisition of MK-8690 Sole Global Rights Full-Year Worldwide Sales Were $65.0 Billion (1% Growth; 2% Growth ex-FX) KEYTRUDA/KEYTRUDA QLEX Sales Were $31.7 Billion (7% Growth Both Nominally and ex-FX); Includes KEYTRUDA QLEX Sales of $40 Million WINREVAIR Sales Were $1.4 Billion CAPVAXIVE Sales Were $759 Million GARDASIL/GARDASIL 9 Sales Were $5.2 Billion (39% Decline Both Nominally and ex-FX) Animal Health Sales Were $6.4 Billion (8% Growth; 9% Growth ex-FX) KEYTRUDA/KEYTRUDA QLEX Sales Were $31.7 Billion (7% Growth Both Nominally and ex-FX); Includes KEYTRUDA QLEX Sales of $40 Million WINREVAIR Sales Were $1.4 Billion CAPVAXIVE Sales Were $759 Million GARDASIL/GARDASIL 9 Sales Were $5.2 Billion (39% Decline Both Nominally and ex-FX) Animal Health Sales Were $6.4 Billion (8% Growth; 9% Growth ex-FX) Full-Year 2025 GAAP EPS Was $7.28; Non-GAAP EPS Was $8.98; GAAP and Non-GAAP EPS Include Charges of $0.20 per Share Related to Certain Business Development Transactions Announced Positive Late-Stage Trial Results From 18 Phase 3 Trials in 2025 Augmented Pipeline and Portfolio Through Acquisitions of Verona Pharma and Cidara Therapeutics and License Agreement With Hengrui Pharma In the Fourth Quarter Received FDA Commissioner’s National Priority Vouchers for Enlicitide and Sacituzumab Tirumotecan (Sac-TMT), Providing an Opportunity To Expedite Potential FDA Review Timelines for These Phase 3 Candidates Presented Positive Results From Phase 3 CORALreef Lipids and HeFH Trials Demonstrating Enlicitide Significantly Reduced LDL-C in Adults Reached Agreement With U.S. Government To Expand Access to Medicines and Lower Costs for Americans Received FDA Commissioner’s National Priority Vouchers for Enlicitide and Sacituzumab Tirumotecan (Sac-TMT), Providing an Opportunity To Expedite Potential FDA Review Timelines for These Phase 3 Candidates Presented Positive Results From Phase 3 CORALreef Lipids and HeFH Trials Demonstrating Enlicitide Significantly Reduced LDL-C in Adults Reached Agreement With U.S. Government To Expand Access to Medicines and Lower Costs for Americans Full-Year 2026 Financial Outlook Anticipates Worldwide Sales To Be Between $65.5 Billion and $67.0 Billion Expects Non-GAAP EPS To Be Between $5.00 and $5.15; Outlook Reflects a One-Time Charge of Approximately $3.65 per Share for the Acquisition of Cidara Anticipates Worldwide Sales To Be Between $65.5 Billion and $67.0 Billion Expects Non-GAAP EPS To Be Between $5.00 and $5.15; Outlook Reflects a One-Time Charge of Approximately $3.65 per Share for the Acquisition of Cidara RAHWAY, N.J.--(BUSINESS WIRE)--Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2025. "In 2025, we continued to advance leading-edge science to deliver transformative medicines and vaccines that are improving health outcomes for patients around the world,” said Robert M. Davis, chairman and chief executive officer. "Our business benefited from demand for our innovative portfolio, including for KEYTRUDA, increasing contributions from new launches in cardiometabolic and respiratory as well as vaccines, and strong performance of Animal Health. The transformation of our portfolio, bolstered by the acquisitions of Verona Pharma and Cidara Therapeutics, is well underway, and momentum is building as we continue to execute on our strategy. Our progress positions us to continue delivering on our purpose for patients and creating durable value for shareholders.” Financial Summary $ in millions, except EPS amounts Fourth Quarter Year Ended 2025 2024 Change Change Ex-Exchange Dec. 31, 2025 Dec. 31, 2024 Change Change Ex-Exchange Sales $16,400 $15,624 5% 4% $65,011 $64,168 1% 2% GAAP net income1 2,963 3,743 -21% -20% 18,254 17,117 7% 9% Non-GAAP net income that excludes certain items1,2* 5,088 4,372 16% 17% 22,513 19,444 16% 18% GAAP EPS 1.19 1.48 -20% -18% 7.28 6.74 8% 10% Non-GAAP EPS that excludes certain items2* 2.04 1.72 19% 19% 8.98 7.65 17% 19% *Refer to table on page 9. Generally 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. Non-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. Fourth-Quarter Sales Performance The following table reflects sales of the Company’s top products and significant performance drivers. Fourth Quarter $ in millions 2025 2024 Change Change Ex-Exchange Commentary Total Sales $16,400 $15,624 5% 4% Pharmaceutical 14,843 14,042 6% 4% Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by a decline in vaccines. KEYTRUDA/ KEYTRUDA QLEX 8,372 7,836 7% 5% Growth 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. GARDASIL/ GARDASIL 9 1,031 1,550 -34% -35% Decline 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. PROQUAD, M-M-R II and VARIVAX 619 594 4% 3% Increase 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. JANUVIA/JANUMET 501 487 3% 3% Growth 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. BRIDION 499 449 11% 11% Growth 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. WINREVAIR 467 200 133% 133% Growth 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. Lynparza* 389 365 7% 4% Growth primarily due to higher demand in several international markets. CAPVAXIVE 279 50 N/M N/M Growth largely due to continued uptake in the U.S. PREVYMIS 275 215 28% 26% Increase primarily due to higher demand in the U.S. as well as in most international markets, reflecting in part the launch of new indications. Lenvima* 272 255 7% 6% Increase due to higher sales in the U.S., primarily reflecting higher demand, partially offset by lower pricing. WELIREG 220 160 37% 37% Growth 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. OHTUVAYRE 178 - - - Represents sales following the Company's Oct. 7, 2025 acquisition of Verona Pharma plc (Verona Pharma). Animal Health 1,505 1,397 8% 6% Growth primarily due to higher demand of livestock products. Livestock 987 889 11% 9% Growth primarily driven by higher demand across all species, as well as improved supply and new product launches. Companion Animal 518 508 2% 0% Growth 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. Other Revenues** 52 185 -71% -15% Decline primarily due to unfavorable impact of revenue-hedging activities and lower revenue from third-party manufacturing arrangements. *Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. **Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. N/M - Not meaningful. Full-Year Sales Performance The following table reflects sales of the Company’s top products and significant performance drivers. Year Ended $ in millions Dec. 31, 2025 Dec. 31, 2024 Change Change Ex-Exchange Total Sales $65,011 $64,168 1% 2% Pharmaceutical 58,142 57,400 1% 1% KEYTRUDA/KEYTRUDA QLEX 31,680 29,482 7% 7% GARDASIL/GARDASIL 9 5,233 8,583 -39% -39% JANUVIA/JANUMET 2,544 2,268 12% 13% PROQUAD, M-M-R II and VARIVAX 2,451 2,485 -1% -2% BRIDION 1,841 1,764 4% 4% Lynparza* 1,450 1,311 11% 10% WINREVAIR 1,443 419 N/M N/M Lenvima* 1,053 1,010 4% 4% PREVYMIS 978 785 25% 23% VAXNEUVANCE 825 808 2% 1% CAPVAXIVE 759 97 N/M N/M WELIREG 716 509 41% 41% ROTATEQ 673 711 -5% -5% Reblozyl* 525 371 41% 41% LAGEVRIO 380 964 -61% -61% Simponi** - 543 -100% -100% Animal Health 6,354 5,877 8% 9% Livestock 3,896 3,462 13% 14% Companion Animal 2,458 2,415 2% 2% Other Revenues*** 515 891 -42% -6% *Alliance revenue for Lynparza and Lenvima represent the Company’s share of profits, which are product sales net of cost of sales and commercialization costs. Alliance revenue for Reblozyl represents royalties. **Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024. ***Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. N/M - Not meaningful. In 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’s recognition of a $150 million upfront payment and $175 million of regulatory milestones. Full-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. Full-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. Fourth-Quarter and Full-Year Expense and Related Information The table below presents selected expense information. $ in millions GAAP Acquisition- and Divestiture- Related Costs3 Restructuring Costs (Income) Loss From Investments in Equity Securities Non- GAAP2 Fourth Quarter 2025 Cost of sales $5,551 $1,054 $1,173 $- $3,324 Selling, general and administrative 2,898 48 2 - 2,848 Research and development 3,886 5 (111) - 3,992 Restructuring costs 213 - 213 - - Other (income) expense, net 432 - - 206 226 Fourth Quarter 2024 Cost of sales $3,828 $701 $121 $- $3,006 Selling, general and administrative 2,864 29 16 - 2,819 Research and development 4,585 12 (1) - 4,574 Restructuring costs 51 - 51 - - Other (income) expense, net 126 (31) - 152 5 $ in millions GAAP Acquisition- and Divestiture- Related Costs3 Restructuring Costs (Income) Loss From Investments in Equity Securities Non- GAAP2 Year Ended Dec. 31, 2025 Cost of sales $16,382 $2,871 $1,484 $- $12,027 Selling, general and administrative 10,733 120 3 - 10,610 Research and development 15,789 19 175 - 15,595 Restructuring costs 889 - 889 - - Other (income) expense, net 151 (3) - (306) 460 Year Ended Dec. 31, 2024 Cost of sales $15,193 $2,409 $495 $- $12,289 Selling, general and administrative 10,816 117 83 - 10,616 Research and development 17,938 72 1 - 17,865 Restructuring costs 309 - 309 - - Other (income) expense, net (24) (79) - 45 10 GAAP Expense, EPS and Related Information Gross 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. Selling, 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. Research 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. Other (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. The effective tax rate was 13.4% for the fourth quarter of 2025 and 13.3% for the full year of 2025. GAAP 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. Non-GAAP Expense, EPS and Related Information Non-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. Non-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. Non-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. Non-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. The non-GAAP effective tax rate was 15.4% for the fourth quarter of 2025 and 14.4% for the full year of 2025. Non-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. A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows. Fourth Quarter Year Ended $ in millions, except EPS amounts 2025 2024 Dec. 31, 2025 Dec. 31, 2024 EPS GAAP EPS $1.19 $1.48 $7.28 $6.74 Difference 0.85 0.24 1.70 0.91 Non-GAAP EPS that excludes items listed below2 $2.04 $1.72 $8.98 $7.65 Net Income GAAP net income1 $2,963 $3,743 $18,254 $17,117 Difference 2,125 629 4,259 2,327 Non-GAAP net income that excludes items listed below1,2 $5,088 $4,372 $22,513 $19,444 Excluded Items: Acquisition- and divestiture-related costs3 $1,107 $711 $3,007 $2,519 Restructuring costs 1,277 187 2,551 888 Loss (income) from investments in equity securities 206 152 (306) 45 Decrease to net income before taxes 2,590 1,050 5,252 3,452 Estimated income tax (benefit) expense4 (465) (421) (993) (1,125) Decrease to net income $2,125 $629 $4,259 $2,327 Pipeline and Portfolio Highlights In 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. Throughout the fourth quarter, the Company made important progress to advance its broad, diverse pipeline, meeting significant regulatory and clinical milestones. Oncology: U.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. Approvals represent the first PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens for this patient population. FDA awarded a priority review voucher under the Commissioner’s National Priority Voucher (CNPV) pilot program for sac-TMT, an investigational anti-TROP2 ADC being developed in collaboration with Kelun-Biotech. European 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. FDA 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. FDA set Prescription Drug User Fee Act (PDUFA) dates in the second half of 2026 for these applications. Announced 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. In 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. U.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. Approvals represent the first PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens for this patient population. FDA awarded a priority review voucher under the Commissioner’s National Priority Voucher (CNPV) pilot program for sac-TMT, an investigational anti-TROP2 ADC being developed in collaboration with Kelun-Biotech. European 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. FDA 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. FDA set Prescription Drug User Fee Act (PDUFA) dates in the second half of 2026 for these applications. Announced 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. In 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. Infectious Diseases: Announced 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-naïve). Announced 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-naïve). Cardiometabolic and Respiratory: Presented 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. FDA awarded a priority review voucher under the CNPV pilot program for enlicitide decanoate. In 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. In February 2026, FDA accepted a new sBLA for WINREVAIR seeking approval to update the U.S. product label based on Phase 3 HYPERION trial. FDA set PDUFA date of September 21, 2026. Announced 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. Presented 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. FDA awarded a priority review voucher under the CNPV pilot program for enlicitide decanoate. In 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. In February 2026, FDA accepted a new sBLA for WINREVAIR seeking approval to update the U.S. product label based on Phase 3 HYPERION trial. FDA set PDUFA date of September 21, 2026. Announced 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. Business Development: In 2026, completed acquisition of Cidara Therapeutics, Inc. (Cidara) for a total transaction value of approximately $9.2 billion. Added MK-1406 (formerly CD388), an investigational long-acting, strain-agnostic antiviral agent designed to prevent influenza infection in individuals at higher risk of complications, to the Company’s portfolio. MK-1406 is currently being evaluated in the Phase 3 ANCHOR study. Entered into strategic financing agreement with Blackstone Life Sciences to partially fund the development of sac-TMT in 2026. Entered into an agreement with Falk for certain development and commercialization rights to MK-8690, an investigational anti-CD30 ligand monoclonal antibody. In 2026, completed acquisition of Cidara Therapeutics, Inc. (Cidara) for a total transaction value of approximately $9.2 billion. Added MK-1406 (formerly CD388), an investigational long-acting, strain-agnostic antiviral agent designed to prevent influenza infection in individuals at higher risk of complications, to the Company’s portfolio. MK-1406 is currently being evaluated in the Phase 3 ANCHOR study. Entered into strategic financing agreement with Blackstone Life Sciences to partially fund the development of sac-TMT in 2026. Entered into an agreement with Falk for certain development and commercialization rights to MK-8690, an investigational anti-CD30 ligand monoclonal antibody. Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.* Oncology FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Perioperative Treatment for Adults With Cisplatin-Ineligible MIBC; Based on Results From Phase 3 KEYNOTE-905 Trial EC Approved Subcutaneous Administration of KEYTRUDA for All Adult Indications Approved in EU; Based on Results From Phase 3 3475A-D77 Trial KEYTRUDA Plus Padcev Significantly Improved EFS, OS and pCR Rates for Cisplatin-Eligible Patients With MIBC When Given Before and After Surgery; Based on Results From Phase 3 KEYNOTE-B15 Trial The Company and Moderna Announced 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA Demonstrated Sustained Improvement in the Primary Endpoint of Recurrence-Free Survival in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection; Based on Follow-up Analysis From Phase 2b KEYNOTE-942/mRNA-4157-P201 Trial The Company Initiated Phase 3 KANDLELIT-007 Trial Evaluating Calderasib (MK-1084), an Investigational Oral KRAS G12C Inhibitor, in Combination With KEYTRUDA QLEX in Certain Patients With Advanced NSCLC The Company Presented Data at the American Society of Hematology Annual Meeting 2025 That Showcased Continued Advancements in Hematology Pipeline and Novel Therapeutic Approaches Vaccines and Infectious Diseases The Company Announced Positive Topline Results From Pivotal Phase 3 Trial Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of DOR/ISL in Treatment-Naïve Adults With HIV-1 Infection Cardiometabolic and Respiratory Enlicitide Decanoate Significantly Reduced LDL-C in Phase 3 CORALreef Lipids Trial Enlicitide Decanoate Significantly Reduced LDL-C in Adults With HeFH in Phase 3 CORALreef HeFH Trial WINREVAIR Met Primary Endpoint in Phase 2, Proof-Of-Concept CADENCE Study in Adults With CpcPH Due to HFpEF Neuroscience The Company Showcased Data for Alzheimer’s Disease Candidates MK-2214 and MK-1167 at Clinical Trials on Alzheimer’s Disease 2025 Animal Health FDA Conditionally Approved EXZOLT CATTLE-CA1 for Prevention and Treatment of New World Screwworm (Cochliomyia Hominivorax) Larvae (Myiasis) *References to the Company’s name in the above news release titles have been modified for the purpose of this announcement. U.S. Government Agreement The Company reached an agreement with the U.S. government that is intended to lower medicine costs for Americans. This agreement enables the Company to continue its long-standing commitment to advancing breakthrough scientific discoveries for patients and helps ensure Americans can access the medicines they need at lower costs. The voluntary agreement addresses all four components of the President’s July letter. Under the agreement, among other things, the Company plans to provide key products through a direct-to-patient program at affordable prices for eligible patients in the U.S. In addition, the Company reached an understanding with the U.S. Department of Commerce to delay Section 232 tariffs for three years, enabling the Company to make investments in the U.S. to reshore manufacturing for American patients. The Company has committed more than $70 billion in capital and R&D spending to strengthen U.S. production and innovation. Full-Year 2026 Financial Outlook The following table summarizes the Company’s full-year financial outlook. Full Year 2026 Sales* $65.5 billion to $67.0 billion Non-GAAP Gross margin2 Approximately 82% Non-GAAP Operating expenses2** $35.9 billion to $36.9 billion Non-GAAP Other (income) expense, net2 Approximately $1.3 billion expense Non-GAAP Effective tax rate2 23.5% to 24.5% Non-GAAP EPS2*** $5.00 to $5.15 Share count (assuming dilution) Approximately 2.48 billion *The Company does not have any non-GAAP adjustments to sales. **Includes a one-time charge of approximately $9.0 billion associated with the acquisition of Cidara. Outlook does not assume any additional significant potential business development transactions. ***Includes a one-time charge of approximately $3.65 per share associated with the acquisition of Cidara. The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results. The Company anticipates full-year 2026 sales to be between $65.5 billion and $67.0 billion, including a positive impact from foreign exchange of approximately 1% at mid-January 2026 exchange rates. The Company’s full-year non-GAAP effective income tax rate is expected to be between 23.5% and 24.5% including the impact of the non-tax deductible one-time charge for the acquisition of Cidara. The Company expects full-year 2026 non-GAAP EPS to be between $5.00 and $5.15, including a positive impact from foreign exchange of approximately $0.10 per share at mid-January 2026 exchange rates. This range includes a one-time charge of approximately $9.0 billion, or approximately $3.65 per share, as well as approximately $0.30 per share of related financing and operational costs, related to the acquisition of Cidara. In 2025, non-GAAP EPS of $8.98 was negatively impacted by one-time charges of $0.20 per share related to certain business development transactions. Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions. Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, as well as income and losses from investments in equity securities. Earnings Conference Call Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, Feb. 3, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website. All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590. About Our Company At Merck & Co., Inc., Rahway, N.J., USA, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “Company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the Company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Appendix Generic product names are provided below. Pharmaceutical BRIDION (sugammadex) CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) ENFLONSIA (clesrovimab-cfor) GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) JANUMET (sitagliptin and metformin HCl) JANUVIA (sitagliptin) KEYTRUDA (pembrolizumab) KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) LAGEVRIO (molnupiravir) Lenvima (lenvatinib) Lynparza (olaparib) M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live) OHTUVAYRE (ensifentrine) PREVYMIS (letermovir) PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) Reblozyl (luspatercept-aamt) ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent) Simponi (golimumab) VARIVAX (Varicella Virus Vaccine Live) VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) WELIREG (belzutifan) WINREVAIR (sotatercept-csrk) Animal Health BRAVECTO (fluralaner) ____________________ 1 Net income attributable to the Company. 2 The Company is providing certain 2025 and 2024 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the Company’s results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release. 3 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations, licensing arrangements and asset acquisitions, and recognition of fair value step-up to inventories for asset acquisitions. 4 Includes the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments for all periods presented. Amount in the full year of 2025 also includes a $60 million net benefit, which reflects a net benefit related to favorable audit reserve adjustments. Amounts in the fourth quarter and full year of 2024 also include a $260 million benefit and a $519 million benefit, respectively, due to reductions 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. The benefit recognized in the fourth quarter of 2024 relates to the 2020 federal tax return year and the benefit for the full year of 2024 relates to both the 2020 and 2019 federal tax return years. 4Q25 4Q24 $ 16,400 $ 15,624 5% $ 65,011 $ 64,168 1% 5,551 3,828 45% 16,382 15,193 8% 2,898 2,864 1% 10,733 10,816 -1% 3,886 4,585 -15% 15,789 17,938 -12% 213 51 889 309 432 126 151 (24 ) 3,420 4,170 -18% 21,067 19,936 6% 458 425 2,804 2,803 2,962 3,745 -21% 18,263 17,133 7% (1 ) 2 9 16 $ 2,963 $ 3,743 -21% $ 18,254 $ 17,117 7% $ 1.19 $ 1.48 -20% $ 7.28 $ 6.74 8% 2,488 2,537 2,507 2,541 13.4 % 10.2 % 13.3 % 14.1 % $ 5,551 1,054 1,173 2,227 $ 3,324 2,898 48 2 50 2,848 3,886 5 (111 ) (106 ) 3,992 213 213 213 – 432 206 206 226 3,420 (1,107 ) (1,277 ) (206 ) (2,590 ) 6,010 458 (187 ) (3) (234 ) (3) (44 ) (3) (465 ) 923 2,962 (920 ) (1,043 ) (162 ) (2,125 ) 5,087 2,963 (920 ) (1,043 ) (162 ) (2,125 ) 5,088 $ 1.19 (0.37 ) (0.42 ) (0.06 ) (0.85 ) $ 2.04 13.4 % 15.4 % $ 16,382 2,871 1,484 4,355 $ 12,027 10,733 120 3 123 10,610 15,789 19 175 194 15,595 889 889 889 – 151 (3 ) (306 ) (309 ) 460 21,067 (3,007 ) (2,551 ) 306 (5,252 ) 26,319 2,804 (525 ) (3) (473 ) (3) 65 (3) (60 ) (4) (993 ) 3,797 18,263 (2,482 ) (2,078 ) 241 60 (4,259 ) 22,522 18,254 (2,482 ) (2,078 ) 241 60 (4,259 ) 22,513 $ 7.28 (0.99 ) (0.83 ) 0.10 0.02 (1.70 ) $ 8.98 13.3 % 14.4 % 2025 2024 4Q Full Year $15,529 $15,806 $17,276 $16,400 $65,011 $15,775 $16,112 $16,657 $15,624 $64,168 5 4 1 2 13,638 14,050 15,611 14,843 58,142 14,006 14,408 14,943 14,042 57,400 6 4 1 1 7,205 7,956 8,142 8,337 31,641 6,947 7,270 7,429 7,836 29,482 6 5 7 7 5 35 40 - - - - 312 370 379 389 1,450 292 317 337 365 1,311 7 4 11 10 258 265 258 272 1,053 255 249 251 255 1,010 7 6 4 4 137 162 196 220 716 85 126 139 160 509 37 37 41 41 119 107 136 164 525 71 90 100 110 371 48 48 41 41 1,327 1,126 1,749 1,031 5,233 2,249 2,478 2,306 1,550 8,583 -34 -35 -39 -39 539 609 684 619 2,451 570 617 703 594 2,485 4 3 -1 -2 230 229 226 140 825 219 189 239 161 808 -13 -16 2 1 107 129 244 279 759 47 50 97 228 121 204 119 673 216 163 193 139 711 -14 -15 -5 -5 41 38 45 42 166 61 59 68 74 263 -43 -44 -37 -37 441 461 439 499 1,841 440 455 420 449 1,764 11 11 4 4 208 228 266 275 978 174 188 208 215 785 28 26 25 23 70 74 81 87 312 56 62 64 70 252 24 23 24 24 83 96 43 25 247 73 92 96 79 340 -68 -68 -27 -27 280 336 360 467 1,443 70 149 200 419 133 133 106 123 112 129 470 98 106 102 109 415 18 18 13 13 68 80 82 83 312 70 72 72 73 287 14 9 9 6 178 178 - - - - 102 83 138 57 380 350 110 383 121 964 -53 -53 -61 -61 90 86 82 67 325 111 89 102 92 394 -27 -28 -18 -18 67 83 77 79 306 56 60 65 69 249 15 9 23 20 45 41 43 42 171 42 39 42 40 163 6 4 5 4 50 40 47 49 186 46 53 78 45 222 8 9 -16 -16 184 172 189 543 -100 -100 39 35 41 114 -100 -100 549 372 382 302 1,604 419 405 278 232 1,334 30 30 20 21 247 251 243 199 940 251 224 204 255 935 -22 -22 1 2 729 584 948 658 2,917 632 618 638 699 2,590 -6 -5 13 13 1,588 1,646 1,615 1,505 6,354 1,511 1,482 1,487 1,397 5,877 8 6 8 9 924 961 1,023 987 3,896 850 837 886 889 3,462 11 9 13 14 664 685 592 518 2,458 661 645 601 508 2,415 2 0 2 2 303 110 50 52 515 258 222 227 185 891 -71 -15 -42 -6