Measles, Mumps, Rubella and Varicella virus vaccine live(Merck & Co., Inc.)

Sales Growth Reflects Continued Strength in Oncology and Animal Health, Plus Contributions From Other Products in Broader Portfolio, Including WINREVAIR Financial Highlights Total Worldwide Sales Were $18.1 Billion (5% Growth; 4% Growth ex-FX) KEYTRUDA/KEYTRUDA QLEX 1 Sales Were $8.6 Billion (6% Growth; 6% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $830 Million WINREVAIR Sales Were $694 Million (93% Growth; 94% Growth ex-FX) Animal Health Sales Were $1.7 Billion (4% Growth; 3% Growth ex-FX) GAAP EPS Was $2.04; Non-GAAP EPS Was $2.49; GAAP and Non-GAAP EPS Include a One-Time Charge of $0.12 per Share Related to a Global License Agreement With SciBrunch Pipeline & Portfolio Highlights Presented First-Time Pivotal Data From Phase 3 Trials Across Robust Oncology Pipeline at ESMO Congress 2026, Including: TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (sac-TMT) in Certain Patients With Advanced or Recurrent Endometrial Cancer; U.S. FDA Accepted for Priority Review a Biologics License Application Based on These Data INTerpath-001 Trial Evaluating Intismeran Autogene Plus KEYTRUDA as Adjuvant Treatment for Patients With Resected Stage IIB-IV Melanoma, in Collaboration With Moderna Announced Positive Phase 2b Results in Moderate to Severe Hidradenitis Suppurativa From Clinical Study of Investigational Immunology Candidate Tulisokibart Presented One-Year Results From Phase 2b/3 BRUNELLO Trial Evaluating Remigromig in Adults With Diabetic Macular Edema Full-Year 2026 Financial Outlook Narrows and Raises the Midpoint of Worldwide Sales Range; Now Expects Sales To Be Between $66.8 Billion and $67.3 Billion Narrows and Raises Expected Non-GAAP EPS Range To Be Between $2.77 and $2.82; Outlook Now Includes One-Time Charge of $0.12 per Share Related to the Global License Agreement With SciBrunch 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 third quarter of 2026. “Our science-led strategy is transforming our business,” said Robert M. Davis, chairman and chief executive officer. “The potentially practice-changing advances in oncology presented at last weekend’s ESMO meeting, including new data for our antibody-drug conjugate sac-TMT and the first Phase 3 validation of a therapeutic cancer vaccine, further clinically de-risk the substantial long-term opportunity of our late-phase pipeline. With positive momentum across multiple therapeutic areas, I’m increasingly confident in our ability to deliver long-term value for patients and shareholders.” Financial Summary $ in millions, except EPS amounts Third Quarter 2026 2025 Change Change Ex- Exchange Sales $18,085 $17,276 5% 4% GAAP net income 2 5,065 5,785 -12% -14% Non-GAAP net income that excludes certain items 2,3* 6,159 6,448 -4% -5% GAAP EPS 2.04 2.32 -12% -13% Non-GAAP EPS that excludes certain items 3* 2.49 2.58 -3% -5% *Refer to table on page 7. For the third quarter of 2026, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $2.04 and non-GAAP EPS was $2.49. Both GAAP and non-GAAP EPS in the third quarter of 2026 include a one-time charge of $0.12 per share related to a global license agreement with SciBrunch Therapeutics Co., Ltd. (SciBrunch). Both GAAP and non-GAAP EPS in the third quarter of 2025 include a charge of $0.10 per share for a milestone payment to LaNova Medicines Ltd. (LaNova, acquired by Sino Biopharmaceutical Limited) associated with the technology transfer for MK-2010. 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. Non-GAAP EPS in the third quarter of 2025 also excludes tax expense relating to audit reserve adjustments. Year-to-date results can be found in the attached tables. Third-Quarter Sales Performance The following table reflects sales of the Company’s top products and significant performance drivers. Third Quarter $ in millions 2026 2025 Change Change Ex- Exchange Commentary Total Sales $18,085 $17,276 5% 4% Pharmaceutical 16,268 15,611 4% 4% Increase primarily driven by growth in KEYTRUDA/KEYTRUDA QLEX, WINREVAIR, GARDASIL/GARDASIL 9, WELIREG, ENFLONSIA and the inclusion of OHTUVAYRE sales. Growth benefited from the timing of purchases by approximately $550 million. Growth was partially offset by declines in BRIDION, JANUVIA/JANUMET and LAGEVRIO, as well as lower alliance revenue related to Koselugo. KEYTRUDA/ KEYTRUDA QLEX 8,601 8,147 6% 6% Growth primarily driven by strong global uptake in earlier-stage indications including triple-negative breast cancer, cervical cancer, head and neck cancer and bladder cancer, as well as higher global demand in metastatic indications, including urothelial cancer. Timing of wholesaler purchases unfavorably affected sales in the U.S. but was largely offset by a benefit from increased inventory in the channel. Sales of KEYTRUDA QLEX were $830 million. GARDASIL/ GARDASIL 9 1,995 1,749 14% 14% Increase primarily due to higher sales in the U.S. reflecting favorable public-sector purchasing patterns and higher net pricing. PROQUAD, M-M-R II and VARIVAX 730 684 7% 7% Increase primarily due to higher demand in certain European markets. WINREVAIR 694 360 93% 94% Growth primarily reflects higher demand and favorable wholesaler and specialty pharmacy purchasing patterns in the U.S., as well as launch uptake in certain international markets, particularly in Europe and Japan. JANUVIA/JANUMET 380 624 -39% -39% Decline primarily driven by lower demand due to generic competition following loss of market exclusivity in the U.S. Lynparza* 352 379 -7% -7% Decline primarily due to lower net pricing in the U.S. and lower demand and pricing in China. PREVYMIS 347 266 30% 31% Increase primarily due to higher demand globally. WELIREG 307 196 56% 58% Growth primarily driven by higher demand in the U.S. and continued launch uptake in international markets, particularly in Japan. Lenvima* 287 258 11% 11% Growth primarily due to higher demand in the U.S. CAPVAXIVE 263 244 8% 7% Increase primarily driven by launch uptake in several international markets, particularly in Asia Pacific and Europe, partially offset by lower sales in the U.S. reflecting lower adult pneumococcal vaccination rates and lower net pricing. ENFLONSIA 187 79 138% 136% Increase primarily driven by seasonal demand and associated inventory build in the U.S. and certain international markets. OHTUVAYRE 184 - - - Product obtained as part of the Company's October 2025 acquisition of Verona Pharma plc. BRIDION 144 439 -67% -67% Decline primarily driven by lower demand in the U.S. due to generic competition following loss of market exclusivity. LAGEVRIO 17 138 -88% -88% Decline largely due to lower demand in Japan. Animal Health 1,676 1,615 4% 3% Growth attributable to both Livestock and Companion Animal product portfolios. Livestock 1,048 1,023 2% 2% Growth primarily driven by higher demand for poultry products. Companion Animal 628 592 6% 6% Growth largely driven by new product launches. Sales of BRAVECTO line of products were $264 million and $262 million in the current and prior-year quarters, respectively, which represents an increase of 1%, or flat excluding impact of foreign exchange. Other Revenues** 141 50 185% -25% Increase primarily due to favorable impact of revenue-hedging activities, partially offset by 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. In addition, Koselugo alliance revenue was $13 million in the third quarter of 2026 compared with $214 million in the third quarter of 2025. The decrease 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 a $50 million regulatory milestone in the third quarter of 2025. Third-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 Third Quarter 2026 Cost of sales $4,892 $1,140 $396 $- $3,356 Selling, general and administrative 2,886 24 - - 2,862 Research and development 4,537 3 1 - 4,533 Restructuring costs 184 - 184 - - Other (income) expense, net 27 - - (393) 420 Third Quarter 2025 Cost of sales $3,855 $621 $110 $- $3,124 Selling, general and administrative 2,633 34 - - 2,599 Research and development 4,234 4 233 - 3,997 Restructuring costs 47 - 47 - - Other (income) expense, net (238) - - (344) 106 GAAP Expense, EPS and Related Information Gross margin was 72.9% for the third quarter of 2026 compared with 77.7% for the third quarter of 2025. The decrease was primarily due to higher amortization of intangible assets, restructuring costs and production costs. Selling, general and administrative (SG&A) expenses were $2.9 billion in the third quarter of 2026, an increase of 10% compared with the third quarter of 2025. The increase was primarily due to higher administrative costs, as well as higher promotional costs in support of product launches. Research and development (R&D) expenses were $4.5 billion in the third quarter of 2026, an increase of 7% compared with the third quarter of 2025. The increase was primarily due to a $400 million charge related to a global license agreement with SciBrunch and higher clinical development spending, partially offset by lower restructuring costs and a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone Life Sciences (Blackstone). R&D expenses in the third quarter of 2025 include a $300 million charge for a milestone payment to LaNova for the completion of the technology transfer for MK-2010. Other (income) expense, net, was $27 million of expense in the third quarter of 2026 compared with $238 million of income in the third quarter of 2025. The unfavorability was primarily due to higher net interest expense. The effective income tax rate for the third quarter of 2026 was 8.9%, reflecting the favorable impacts of certain discrete items, as well as jurisdictional mix of income and expense. GAAP EPS was $2.04 for the third quarter of 2026 compared with $2.32 for the third quarter of 2025. The decrease was primarily driven by higher operating expenses, reflecting increased investments to advance the R&D pipeline and support product launches, higher amortization of intangible assets, higher net interest expense and increased restructuring costs, partially offset by operational strength in the business and a lower effective income tax rate. Non-GAAP Expense, EPS and Related Information Non-GAAP gross margin was 81.4% for the third quarter of 2026 compared with 81.9% for the third quarter of 2025. The decrease was primarily due to higher production costs. Non-GAAP SG&A expenses were $2.9 billion in the third quarter of 2026, an increase of 10% compared with the third quarter of 2025. The increase was primarily due to higher administrative costs, as well as higher promotional costs in support of product launches. Non-GAAP R&D expenses were $4.5 billion in the third quarter of 2026, an increase of 13% compared with the third quarter of 2025. The increase was primarily due to a $400 million charge related to a global license agreement with SciBrunch and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone. R&D expenses in the third quarter of 2025 include a $300 million charge for a milestone payment to LaNova for the completion of the technology transfer for MK-2010. Non-GAAP other (income) expense, net, was $420 million of expense in the third quarter of 2026 compared with $106 million of expense in the third quarter of 2025. The unfavorability was primarily due to higher net interest expense. The non-GAAP effective income tax rate for the third quarter of 2026 was 10.9%, reflecting the favorable impacts of certain discrete items, as well as jurisdictional mix of income and expense. Non-GAAP EPS was $2.49 for the third quarter of 2026 compared with $2.58 for the third quarter of 2025. The decrease was primarily driven by higher operating expenses, reflecting increased investments to advance the R&D pipeline and support product launches, and higher net interest expense, partially offset by operational strength in the business and a lower effective income tax rate. A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows. Third Quarter $ in millions, except EPS amounts 2026 2025 EPS GAAP EPS $2.04 $2.32 Difference 0.45 0.26 Non-GAAP EPS that excludes items listed below 3 $2.49 $2.58 Net Income GAAP net income 2 $5,065 $5,785 Difference 1,094 663 Non-GAAP net income that excludes items listed below 2,3 $6,159 $6,448 Excluded Items: Acquisition- and divestiture-related costs 4 $1,167 $659 Restructuring costs 581 390 Income from investments in equity securities (393) (344) Decrease to net income before taxes 1,355 705 Estimated income tax (benefit) expense 5 (261) (42) Decrease to net income $1,094 $663 Pipeline and Portfolio Highlights In the third quarter, the Company achieved key regulatory and clinical milestones to meaningfully advance its broad and diverse pipeline. Oncology: U.S. Food and Drug Administration (U.S. FDA) approved WELIREG plus Lenvima, in collaboration with Eisai, for certain previously treated adult patients with advanced renal cell carcinoma with a clear cell component (ccRCC), based on Phase 3 LITESPARK-011 trial. Approval represents first approved combination of an oral hypoxia-inducible factor-2 alpha inhibitor and a multi-targeted vascular endothelial growth factor tyrosine kinase inhibitor (TKI) for these patients. In October, U.S. FDA accepted a Biologics License Application (BLA) seeking approval of sac-TMT for the treatment of adult patients with endometrial cancer who have previously received platinum containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor, separately or in combination, based on Phase 3 TroFuse-005 trial. U.S. FDA set Prescription Drug User Fee Act (PDUFA) date of June 15, 2027. The Company is in discussions with the U.S. FDA and is hopeful for an earlier approval. In October, European Commission (EC) approved KEYTRUDA plus Padcev as perioperative treatment for adults with resectable muscle-invasive bladder cancer (MIBC), based on Phase 3 KEYNOTE-B15 trial. Ministry of Health, Labor and Welfare in Japan approved subcutaneous pembrolizumab and berahyaluronidase alfa injection under the trademark KEYJECT (marketed as KEYTRUDA QLEX in the U.S.) for all KEYTRUDA indications approved in Japan, based on Phase 3 MK-3475A-D77 trial. At the European Society for Medical Oncology (ESMO) Congress 2026 in October, positive new data were presented during three late-breaking Presidential Symposia across three Phase 3 trials from the Company’s robust oncology pipeline and portfolio, including: Results from Phase 3 TroFuse-005 trial evaluating sac-TMT for patients with advanced or recurrent endometrial cancer previously treated with chemotherapy and anti-PD-1/L1 immunotherapy. Results from Phase 3 INTerpath-001 trial, in collaboration with Moderna, Inc. (Moderna), evaluating adjuvant treatment with intismeran autogene (intismeran; V940 or mRNA-4157) in combination with KEYTRUDA. Results from Phase 3 KEYNOTE-C93 trial evaluating KEYTRUDA monotherapy versus platinum doublet chemotherapy as a first-line treatment for certain patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer who had not previously received systemic chemotherapy or who experienced recurrence more than six months after completing prior adjuvant therapy. In addition, data were presented from Phase 3 OptiTROP studies in China, led by Kelun-Biotech, evaluating sac-TMT in non-small cell lung cancer (NSCLC), including: Results from the OptiTROP-Lung06 study as first-line treatment for PD-L1-negative advanced non-squamous NSCLC. Final overall survival data from the OptiTROP-Lung04 study in epidermal growth factor receptor (EGFR)-mutated NSCLC following progression on EGFR TKIs. Ifinatamab deruxtecan (I-DXd) Biologics License Application (BLA), in collaboration with Daiichi Sankyo, for certain patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) was voluntarily withdrawn. Vaccines and Infectious Diseases: U.S. FDA accepted a supplemental BLA (sBLA) for ENFLONSIA to expand its indication to include prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under 2 years of age at increased risk for severe RSV disease through their second RSV season, based on Phase 3 SMART trial. U.S. FDA set PDUFA date of March 22, 2027. Applications to expand marketing authorization for ENFLONSIA for same population in Europe and Japan, based on Phase 3 SMART trial, have also been accepted. U.S. FDA accepted a supplemental New Drug Application (sNDA) for IDVYNSO for the treatment of certain adults with HIV-1 infection who had not previously received antiretroviral treatment, based on Phase 3 P053 trial. U.S. FDA also accepted an sNDA to include 96-week data for IDVYNSO in certain virologically suppressed adults, based on the Phase 3 P051 and P052 trials. U.S. FDA set a PDUFA date for both sNDAs of April 22, 2027. Cardiometabolic, Respiratory and Specialty: U.S. FDA approved an update to U.S. product label for WINREVAIR to include efficacy and safety data from the Phase 3 HYPERION trial evaluating adults recently diagnosed with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1 pulmonary hypertension). In HYPERION, in patients diagnosed with PAH in the last 12 months, adding WINREVAIR on top of background therapy reduced the risk of clinical worsening events compared to placebo. Immunology: Presented results from Phase 2b study of tulisokibart in adults with moderate to severe hidradenitis suppurativa (HS). Ophthalmology: At the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in October, presented for the first time one-year results from Phase 2b/3 BRUNELLO trial evaluating remigromig, an investigational, tetravalent, tri-specific antibody designed to agonize the Wingless-related integration site (Wnt) pathway, in adults with diabetic macular edema (DME). Business Development: Announced an exclusive global license agreement with SciBrunch for MK-2690 (SPR2015), an investigational preclinical oral KRAS G12D (ON) inhibitor. 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 Sac-TMT Reduced Risk of Death by 32% and Risk of Disease Progression or Death by 41% Compared to Chemotherapy in Certain Patients With Advanced or Recurrent Endometrial Cancer; Results From Phase 3 TroFuse-005 Trial The Company and Moderna Presented Results From Landmark Phase 3 INTerpath-001 Trial for Intismeran Plus KEYTRUDA at ESMO 2026 Presidential Symposium; Intismeran Plus KEYTRUDA Significantly Reduced Risk of Recurrence or Death by 42% (HR=0.58 [95% CI, 0.45–0.75]; Two-Sided p<0.001) Compared to KEYTRUDA Alone for Patients With Completely Resected Stage IIB-IV Melanoma KEYTRUDA as Monotherapy Reduced Risk of Disease Progression or Death by 43% for Certain Patients With Advanced or Recurrent Endometrial Cancer With dMMR Tumors Compared to Chemotherapy; Results From Phase 3 KEYNOTE-C93 Trial U.S. FDA Approved WELIREG Plus Lenvima for Certain Previously Treated Adult Patients With ccRCC; Based on Results From Phase 3 LITESPARK-011 Trial, Presented at ESMO KEYTRUDA QLEX Approved in Japan for Subcutaneous Administration for All KEYTRUDA Indications Approved in Japan; Based on Results From Phase 3 MK-3475A-D77 Trial EC Approved KEYTRUDA Plus Padcev as Perioperative Treatment for Adults With Resectable MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial I-DXd BLA for Certain Patients With ES-SCLC Voluntarily Withdrawn The Company Entered Into Exclusive Global License Agreement With SciBrunch for SPR2015, an Investigational Oral KRAS G12D (ON) Inhibitor Vaccines and Infectious Diseases U.S. FDA Accepted sBLA for ENFLONSIA to Update Its RSV LRTD Indication to Include Children Under 2 Years at Increased Risk for Severe RSV for Their Second Season; Based on Results From Phase 3 SMART Trial; FDA Set PDUFA Date of March 22, 2027 Cardiometabolic, Respiratory and Specialty U.S. FDA Approved Update to the Label for WINREVAIR to Include Data From the Phase 3 HYPERION Trial Evaluating Adults Recently Diagnosed With PAH (PAH, WHO Group 1 Pulmonary Hypertension) Immunology Tulisokibart Met Primary and Key Secondary Endpoints in Phase 2b Study in Patients With Moderate to Severe HS Ophthalmology The Company Presented One-Year Results From Pivotal Phase 2b/3 BRUNELLO Study Evaluating Remigromig, a Tri-Specific Agonist of the Wnt Pathway, in Adults With DME, at AAO 2026 *References in the above news release titles have been modified for the purpose of this announcement. Sustainability Highlights The Company’s 2025/2026 Purpose for Progress Impact Report provided a comprehensive view of the Company’s measurable progress across its sustainability priorities, including achieving all goals targeted for completion by 2025. The Company also introduced new targets for 2030, including a goal to reach 100 million people with access solutions that close gaps in care by 2030. Full-Year 2026 Financial Outlook The following table summarizes the Company’s full-year financial outlook. Full Year 2026 Updated Prior Sales * $66.8 billion to $67.3 billion $66.3 billion to $67.3 billion Non-GAAP Gross margin 3 Approximately 81% Approximately 81% Non-GAAP Operating expenses 3** $42.4 billion to $42.9 billion $42.0 billion to $42.7 billion Non-GAAP Other (income) expense, net 3 Approximately $1.4 billion expense Approximately $1.4 billion expense Non-GAAP Effective income tax rate 3 32.0% to 33.0% 35.0% to 36.0% Non-GAAP EPS 3*** $2.77 to $2.82 $2.66 to $2.76 Share count (assuming dilution) Approximately 2.48 billion Approximately 2.48 billion *The Company does not have any non-GAAP adjustments to sales. **Includes one-time R&D charges of $9.0 billion for the acquisition of Cidara Therapeutics, Inc. (Cidara), $5.7 billion for the acquisition of Terns Pharmaceuticals, Inc. (Terns), and $400 million related to the global license agreement with SciBrunch. Outlook does not assume any additional significant potential business development transactions. ***Includes one-time charges of $3.62 per share for the acquisition of Cidara, $2.31 per share for the acquisition of Terns, and $0.12 per share related to the global license agreement with SciBrunch. 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