Golimumab

July 29, 2025 6:30 am ET Total Worldwide Sales Were $15.8 Billion, a Decrease of 2% From Second Quarter 2024 Both Nominally and Excluding the Impact of Foreign Exchange KEYTRUDA Sales Were $8.0 Billion, Growth of 9% Both Nominally and Excluding the Impact of Foreign Exchange WINREVAIR Sales Were $336 Million Animal Health Sales Were $1.6 Billion, Growth of 11% Both Nominally and Excluding the Impact of Foreign Exchange GARDASIL/GARDASIL 9 Sales Were $1.1 Billion, a Decline of 55% Both Nominally and Excluding the Impact of Foreign Exchange GAAP EPS Was $1.76; Non-GAAP EPS Was $2.13; GAAP and Non-GAAP EPS Include a Charge of $0.07 per Share for Closing of Hengrui Pharma License Agreement Announced Agreement To Acquire Verona Pharma and Its First-In-Class COPD Maintenance Treatment for Adults, Ohtuvayre®;1 Transaction Expected To Close in Fourth Quarter 2025 Announced Positive Topline Results From First Two Phase 3 CORALreef Trials of Enlicitide Decanoate for Treatment of Adults With Hyperlipidemia Received FDA Approval of ENFLONSIA for Prevention of RSV Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season; CDC’s ACIP Recommended ENFLONSIA for Prevention of RSV in Infants Younger Than 8 Months of Age for Their First RSV Season Announced Multiyear Optimization Initiative Anticipated To Result in Approximately $3.0 Billion of Annual Cost Savings by the End of 2027, To Be Fully Reinvested Into Strategic Growth Areas Full-Year 2025 Financial Outlook Narrows Expected Worldwide Sales Range To Be Between $64.3 Billion and $65.3 Billion Narrows Expected Non-GAAP EPS Range To Be Between $8.87 and $8.97 Outlook Does Not Include Anticipated Impact of the Announced Acquisition of Verona Pharma KEYTRUDA Sales Were $8.0 Billion, Growth of 9% Both Nominally and Excluding the Impact of Foreign Exchange WINREVAIR Sales Were $336 Million Animal Health Sales Were $1.6 Billion, Growth of 11% Both Nominally and Excluding the Impact of Foreign Exchange GARDASIL/GARDASIL 9 Sales Were $1.1 Billion, a Decline of 55% Both Nominally and Excluding the Impact of Foreign Exchange Narrows Expected Worldwide Sales Range To Be Between $64.3 Billion and $65.3 Billion Narrows Expected Non-GAAP EPS Range To Be Between $8.87 and $8.97 Outlook Does Not Include Anticipated Impact of the Announced Acquisition of Verona Pharma 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 second quarter of 2025. "Earlier this month, we were pleased to announce our pending acquisition of Verona Pharma, which augments our portfolio and pipeline and is another example of acting decisively when science and value align,” said Robert M. Davis, chairman and chief executive officer. “Today, we announced a multiyear optimization initiative that will redirect investment and resources from more mature areas of our business to our burgeoning array of new growth drivers, further enable the transformation of our portfolio, and drive our next chapter of productive, innovation-driven growth. With these actions, I am confident that we are well positioned to generate near- and long-term value for our shareholders and, most importantly, deliver for our patients.” Financial Summary $ in millions, except EPS amounts Second Quarter 2025 2024 Change Change Ex- Exchange Sales $15,806 $16,112 -2% -2% GAAP net income2 4,427 5,455 -19% -17% Non-GAAP net income that excludes certain items2,3* 5,366 5,809 -8% -6% GAAP EPS 1.76 2.14 -18% -16% Non-GAAP EPS that excludes certain items3* 2.13 2.28 -7% -5% *Refer to table on page 7. For the second quarter of 2025, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.76 and non-GAAP EPS was $2.13. GAAP and non-GAAP EPS in the second quarter of 2025 include a charge of $0.07 per share for an upfront payment to Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) upon closing of a license agreement. 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 the second quarter of 2025 also excludestax benefits primarily resulting from favorable audit adjustments. Non-GAAP EPS in the second quarter of 2024 also excludes a tax 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 the 2019 federal tax return year. Year-to-date results can be found in the attached tables. Second-Quarter Sales Performance The following table reflects sales of the Company’s top products and significant performance drivers. Second Quarter $ in millions 2025 2024 Change Change Ex- Exchange Commentary Total Sales $15,806 $16,112 -2% -2% Pharmaceutical 14,050 14,408 -2% -3% Decline primarily due to vaccines and immunology, partially offset by growth in oncology and cardiology. KEYTRUDA 7,956 7,270 9% 9% Growth driven by continued strong global demand from metastatic indications, including bladder, endometrial and gastric cancers, and increased global uptake in earlier-stage indications, including triple-negative breast cancer, renal cell carcinoma (RCC) and cervical cancer, as well as non-small cell lung cancer in the U.S. GARDASIL/GARDASIL 9 1,126 2,478 -55% -55% Decline primarily due to lower demand in China. Excluding China, sales declined 3%, or 4% excluding impact of foreign exchange, reflecting lower demand in Japan following a national catch-up immunization program, as well as timing of public-sector purchases in certain international markets. U.S. sales increased 2% in the quarter. JANUVIA/JANUMET 623 629 -1% - Decrease primarily attributable to lower demand in China, impacts of generic competition in most international markets, and lower demand in the U.S. due to competitive pressure, which were largely offset by higher net pricing in the U.S. PROQUAD, M-M-R II and VARIVAX 609 617 -1% -2% Decrease primarily reflects lower U.S. sales due to unfavorable VARIVAX public-sector activity and M-M-R II private-sector buy-out, partially offset by partial replenishment of PROQUAD doses borrowed from the U.S. Centers for Disease Control and Prevention (CDC) Pediatric Vaccine Stockpile, and higher pricing. BRIDION 461 455 1% 1% Increase primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition. Lynparza* 370 317 17% 15% Growth primarily due to higher demand in the U.S. and certain international markets. WINREVAIR 336 70 N/M N/M Growth reflects continued uptake since second-quarter 2024 launch in the U.S. Lenvima* 265 249 6% 5% Increase primarily due to higher sales in the U.S. reflecting higher demand, partially offset by lower pricing. VAXNEUVANCE 229 189 21% 20% Growth primarily due to favorable public-sector activity in the U.S. and increased demand in certain international markets, partially offset by lower demand in the U.S. and Japan due to competitive pressure. PREVYMIS 228 188 21% 20% Growth primarily due to higher demand in the U.S. and Europe, partially offset by lower demand in China due to generic competition. WELIREG 162 126 29% 29% Growth primarily driven by higher demand in the U.S. and early launch uptake in certain EU markets, partially offset by lower pricing in the U.S. CAPVAXIVE 129 - - - Represents continued uptake since third-quarter 2024 launch in the U.S. SIMPONI - 172 -100% -100% Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024. Animal Health 1,646 1,482 11% 11% Growth primarily due to higher demand for Livestock products, as well as inclusion of sales from Elanco aqua business acquired in July 2024, higher pricing and improved supply. Livestock 961 837 15% 16% Growth primarily driven by higher demand across all species, as well as inclusion of sales from Elanco aqua business acquired in July 2024. Companion Animal 685 645 6% 6% Increase primarily driven by higher pricing. Sales of BRAVECTO were $335 million and $331 million in current and prior year quarters, respectively, which represents an increase of 1%, both nominally and excluding impact of foreign exchange. Other Revenues** 110 222 -50% -3% Primarily due to unfavorable impact of revenue-hedging activities. *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. Second-Quarter Expense, EPS and Related Information The table below presents selected expense information. $ in millions GAAP Acquisition- and Divestiture- Related Costs4 Restructuring Costs (Income) Loss From Investments in Equity Securities Non- GAAP3 Second Quarter 2025 Cost of sales $3,557 $576 $165 $- $2,816 Selling, general and administrative 2,649 15 1 - 2,633 Research and development 4,048 3 53 - 3,992 Restructuring costs 560 - 560 - - Other (income) expense, net (7) - - (61) 54 Second Quarter 2024 Cost of sales $3,745 $606 $66 $- $3,073 Selling, general and administrative 2,739 24 31 - 2,684 Research and development 3,500 20 - - 3,480 Restructuring costs 80 - 80 - - Other (income) expense, net 42 (17) - (49) 108 GAAP Expense, EPS and Related Information Gross margin was 77.5% for the second quarter of 2025 compared with 76.8% for the second quarter of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by higher restructuring costs and inventory write-offs. Selling, general and administrative (SG&A) expenses were $2.6 billion in the second quarter of 2025, a decrease of 3% compared with the second quarter of 2024. The decrease was primarily due to lower administrative, restructuring and promotional costs. Research and development (R&D) expenses were $4.0 billion in the second quarter of 2025, an increase of 16% compared with the second quarter of 2024. The increase was primarily due to a $200 million charge for an upfront payment made in the second quarter of 2025 for a license agreement with Hengrui Pharma, increased clinical development spending, higher compensation and benefit costs, and higher restructuring costs. Other (income) expense, net, was $7 million of income in the second quarter of 2025 compared with $42 million of expense in the second quarter of 2024. The effective tax rate of 11.4% for the second quarter of 2025 includes a 2.9 percentage point favorable impact due to tax benefits primarily resulting from favorable audit adjustments. GAAP EPS was $1.76 for the second quarter of 2025 compared with $2.14 for the second quarter of 2024. The decrease reflects increased operating expenses driven by higher restructuring costs and research and development spending, a charge related to the closing of a license agreement with Hengrui Pharma, unfavorable tax impacts, and the unfavorable impact of foreign exchange. Non-GAAP Expense, EPS and Related Information Non-GAAP gross margin was 82.2% for the second quarter of 2025 compared with 80.9% for the second quarter 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 $2.6 billion in the second quarter of 2025, a decrease of 2% compared with the second quarter of 2024. The decrease was primarily due to lower administrative and promotional costs. Non-GAAP R&D expenses were $4.0 billion in the second quarter of 2025, an increase of 15% compared with the second quarter of 2024. The increase was primarily due to a $200 million charge for an upfront payment made in the second quarter of 2025 for a license agreement with Hengrui Pharma, increased clinical development spending, and higher compensation and benefit costs. Non-GAAP other (income) expense, net, was $54 million of expense in the second quarter of 2025 compared with $108 million of expense in the second quarter of 2024. The non-GAAP effective tax rate was 15.0% for the second quarter of 2025. Non-GAAP EPS was $2.13 for the second quarter of 2025 compared with $2.28 for the second quarter of 2024. The decrease reflects increased operating expenses driven by higher research and development spending, a charge related to the closing of a license agreement with Hengrui Pharma, and the unfavorable impact of foreign exchange. A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows. Second Quarter $ in millions, except EPS amounts 2025 2024 EPS GAAP EPS $1.76 $2.14 Difference 0.37 0.14 Non-GAAP EPS that excludes items listed below3 $2.13 $2.28 Net Income GAAP net income2 $4,427 $5,455 Difference 939 354 Non-GAAP net income that excludes items listed below2,3 $5,366 $5,809 Excluded Items: Acquisition- and divestiture-related costs4 $594 $633 Restructuring costs 779 177 Income from investments in equity securities (61) (49) Decrease to net income before taxes 1,312 761 Estimated income tax (benefit) expense5 (373) (407) Decrease to net income $939 $354 Planned Acquisition of Verona Pharma On July 9, 2025, the Company furthered its science-led business development strategy by announcing an agreement under which the Company, through a subsidiary, will acquire Verona Pharma plc (Verona Pharma) for $107 per American Depository Share, each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately $10 billion. Through the acquisition, the Company will add Ohtuvayre, a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), to its growing cardio-pulmonary pipeline and portfolio. The U.S. Food and Drug Administration (FDA) approved Ohtuvayre in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is the first novel inhaled mechanism for the treatment of COPD in more than 20 years. The transaction is anticipated to close in the fourth quarter of 2025. Pipeline and Portfolio Highlights In the second quarter, the Company continued to advance its broad and diverse pipeline with multiple regulatory and clinical milestones. In oncology, the FDA approved KEYTRUDA as part of a therapy regimen for the treatment of certain adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC), based on results from the Phase 3 KEYNOTE-689 trial. This approval is the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced HNSCC whose tumors express PD-L1 (CPS ≥1). In addition, the Ministry of Health, Labor and Welfare (MHLW) in Japan approved WELIREG as monotherapy for the treatment of adults with von Hippel-Lindau (VHL) disease-associated tumors, and for adults with unresectable or metastatic RCC that has progressed after chemotherapy. At the 2025 American Society of Clinical Oncology Annual Meeting, the Company announced new research across more than 25 types of cancer in multiple treatment settings. Data were presented for several candidates, including MK-1084, an investigational oral selective KRAS G12C inhibitor, and from the Company’s pipeline of antibody-drug conjugates (ADCs). The Company also presented data from Phase 3 trials evaluating new combination regimens with KEYTRUDA, and longer-term data for studies of KEYTRUDA and WELIREG, with the KEYTRUDA studies including people with earlier stages of cancer. The Company announced results from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65) evaluating KEYTRUDA plus chemotherapy, which met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 and in all comers, as well as a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. In addition, a pre-specified interim analysis of the Phase 3 KEYNOTE-937 study found that compared to placebo, KEYTRUDA did not show a statistically significant improvement in the primary endpoint of recurrence-free survival for certain patients with hepatocellular carcinoma. Also, a pre-specified interim analysis of the Phase 3 LEAP-014 trial found that KEYTRUDA plus Lenvima, in combination with platinum-based chemotherapy, did not show a statistically significant improvement in its primary endpoint of OS compared to KEYTRUDA plus chemotherapy for the first-line treatment of patients with metastatic esophageal squamous cell carcinoma (ESCC). In vaccines and infectious diseases, the Company received FDA approval of ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. ENFLONSIA is the first and only RSV preventive option administered to infants using the same dose regardless of weight. The CDC’s Advisory Committee on Immunization Practices (ACIP) also recommended ENFLONSIA for the prevention of RSV in infants younger than 8 months of age born during or entering their first RSV season. In addition, the Company announced initiation of the MOBILIZE-1 Phase 3 trial evaluating V181, an investigational single-dose quadrivalent vaccine for the prevention of dengue disease. In addition, the FDA accepted a New Drug Application (NDA) for doravirine/islatravir, an investigational, once-daily, oral, two-drug regimen for the treatment of adults with virologically suppressed HIV-1 based on the Phase 3 MK-8591A-051 and MK-8591A-052 trials. The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026. The Company also announced the initiation of the EXPrESSIVE Phase 3 trials for MK-8527, its investigational once-monthly oral candidate for HIV pre-exposure prophylaxis (PrEP). In cardiovascular disease, the Company announced positive topline results from Phase 3 CORALreef HeFH and CORALreef AddOn, the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia already on lipid-lowering therapies, including at least a statin. In both trials, enlicitide demonstrated statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol. If approved, it would be the first marketed oral PCSK9 inhibitor. In addition, the FDA granted priority review for a new supplemental Biologics License Application for WINREVAIR seeking approval to update the U.S. product label based on compelling results from the Phase 3 ZENITH trial. The FDA has set a PDUFA date of Oct. 25, 2025. The Company also provided an update on the Phase 3 HYPERION study evaluating WINREVAIR in recently diagnosed adults with pulmonary arterial hypertension (PAH). In the study, WINREVAIR added on top of background therapy within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo. Further, the MHLW in Japan approved sotatercept for the treatment of adults with PAH under the trademark AIRWIN. It is the first activin signaling inhibitor therapy for PAH approved in Japan. In the Animal Health business, the FDA approved BRAVECTO QUANTUM, an injectable formulation of BRAVECTO for dogs for the treatment and persistent killing of fleas and ticks. In addition, the European Commission (EC) approved NUMELVI tablets for dogs, a once-daily, second-generation Janus kinase (JAK) inhibitor, indicated for the treatment of pruritus associated with allergic dermatitis including atopic dermatitis and treatment of clinical manifestations of atopic dermatitis. 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 for PD-L1+ Resectable Locally Advanced HNSCC as Neoadjuvant Treatment, Continued as Adjuvant Treatment Combined With Radiotherapy With or Without Cisplatin Then as a Single Agent; Based on Results From Phase 3 KEYNOTE-689 Trial FDA Approved WELIREG for Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma; Based on Results From Phase 2 LITESPARK-015 Clinical Trial Phase 3 KEYNOTE-B96 Trial Met Primary Endpoint of PFS in Patients With Platinum-Resistant Recurrent Ovarian Cancer Whose Tumors Expressed PD-L1 and in All Comers KEYTRUDA Plus Trodelvy Reduced Risk of Disease Progression or Death by 35% Versus KEYTRUDA Plus Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer; Based on Results From Phase 3 ASCENT-04/KEYNOTE-D19 Trial MK-1084, an Investigational KRAS G12C Inhibitor, Showed Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations Investigational Zilovertamab Vedotin at 1.75 mg/kg Dose Plus Standard of Care Showed Promising Antitumor Activity, Including Complete Response Rate, in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma; Based on Results From Phase 2 WaveLINE-003 Trial IDeate-Prostate01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Patients With Pretreated Metastatic Castration-Resistant Prostate Cancer IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients With Pretreated Advanced or Metastatic ESCC Vaccines and Infectious Diseases FDA Approved ENFLONSIA for Prevention of RSV Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season; Based on Results From Phase 2b/3 CLEVER Trial ACIP Recommended Use of ENFLONSIA for Prevention of RSV Lower Respiratory Tract Disease in Infants Younger Than 8 Months of Age Born During or Entering Their First RSV Season FDA Accepted NDA for Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults With Virologically Suppressed HIV-1; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials; FDA Set PDUFA Date of April 28, 2026 EXPrESSIVE Phase 3 Trials Initiated for Investigational Once-Monthly HIV Prevention Pill, MK-8527 The Company Initiated MOBILIZE-1 Phase 3 Study Evaluating Dengue Vaccine Candidate Cardiovascular FDA Granted Priority Review for WINREVAIR to Update Label Based on Results From ZENITH Trial; FDA Set PDUFA Date of Oct. 25, 2025 The Company Announced Positive Topline Results From First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia Phase 3 HYPERION Study of WINREVAIR Met Primary Endpoint in Recently Diagnosed Adults With PAH Animal Health FDA Approved BRAVECTO QUANTUM EC Approved NUMELVI Tablets for Dogs *References to the Company’s name in the above news release titles have been modified for the purpose of this announcement. New Multiyear Optimization Initiative, Which Includes a Restructuring Program The Company launched a new multiyear optimization initiative to enable the transformation of its portfolio by generating an expected $3.0 billion in annual cost savings from productivity actions, which will be fully reinvested to support new product launches and its pipeline across multiple therapeutic areas. In July 2025, as part of this initiative, the Company approved a new restructuring program, in which it expects to eliminate certain administrative, sales and R&D positions. The Company will, however, continue to hire employees into new roles across strategic growth areas of the business. In addition, the Company will reduce its global real estate footprint and continue to optimize its manufacturing network, aligning the geography of its global manufacturing to its customers and reflecting changes in the Company’s business. The Company anticipates cumulative pretax costs related to the program to be approximately $3.0 billion. For the second quarter of 2025, the Company recorded charges in its GAAP results of $649 million related to this restructuring program. The Company expects the actions under the restructuring program to result in annual cost savings of approximately $1.7 billion, which will be substantially realized by the end of 2027. This restructuring program is part of the multiyear optimization initiative expected to achieve $3.0 billion in annual cost savings by the end of 2027. Manufacturing and R&D Investment The Company continued to make long-term investments in its U.S. manufacturing and R&D capabilities. This includes the start of construction for a $1.0 billion, 470,000-square-foot state-of-the-art biologics center of excellence in Wilmington, Delaware, which will serve as a launch and commercial production facility and the primary U.S. manufacturing site for KEYTRUDA. In addition, the Company announced an $895 million expansion of its Animal Health manufacturing facility in De Soto, Kansas; the 200,000-square-foot facility will increase capacity for Animal Health vaccines and biologic products. Full-Year 2025 Financial Outlook The following table summarizes the Company’s full-year financial outlook. Full Year 2025 Updated Prior Sales* $64.3 billion to $65.3 billion $64.1 billion to $65.6 billion Non-GAAP Gross margin3 Approximately 82% Approximately 82% Non-GAAPOperating expenses3** $25.6 billion to $26.4 billion $25.6 billion to $26.6 billion Non-GAAPOther (income) expense, net3 $300 million to $400 million expense $300 million to $400 million expense Non-GAAPEffective tax rate3 15.0% to 16.0% 15.5% to 16.5% Non-GAAPEPS3*** $8.87 to $8.97 $8.82 to $8.97 Share count (assuming dilution) Approximately 2.51 billion Approximately 2.51 billion *The Company does not have any non-GAAP adjustments to sales. **Includes one-time R&D charges of $300 million for a milestone payment to LaNova Medicines Ltd. (LaNova) associated with the technology transfer for MK-2010 expected to be recorded in the third quarter of 2025 and $200 million for the upfront payment for the license agreement completed with Hengrui Pharma in the second quarter of 2025. Outlook does not assume any additional significant potential business development transactions. ***Includes one-time charges totaling $0.16 per share associated with the payment for the LaNova technology transfer for MK-2010 and upfront payment to Hengrui Pharma. 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 now expects full-year 2025 sales to be between $64.3 billion and $65.3 billion, including a revised negative impact of foreign exchange of approximately 0.5% at mid-July 2025 exchange rates. The Company now expects its full-year non-GAAP effective income tax rate to be between 15.0% and 16.0%. The Company now expects its full-year non-GAAP EPS to be between $8.87 and $8.97, including a revised negative impact of foreign exchange of approximately $0.15 per share. This revised non-GAAP EPS range continues to reflect the impacts of a one-time charge of $200 million (recorded in the second quarter of 2025) for an upfront payment made in connection with the closing of a license agreement with Hengrui Pharma and the one-time charge of $300 million (to be recorded in the third quarter of 2025) related to a payment to LaNova for the completion of the technology transfer for MK-2010, which will impact EPS by approximately $0.16 in the aggregate. In 2024, non-GAAP EPS of $7.65 was negatively impacted by a net charge of $1.28 per share related to certain asset acquisitions, licensing agreements and collaborations. The financial outlook does not include the anticipated impact of the announced acquisition of Verona Pharma. Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions. The $200 million of costs previously included in the Company’s financial outlook related to the impact of tariffs is unchanged pending the outcome of additional potential government actions. Earnings Conference Call Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, July 29, 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) Lenvima (lenvatinib) Lynparza (olaparib) M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live) PREVYMIS (letermovir) PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) SIMPONI (golimumab) VARIVAX (Varicella Virus Vaccine Live) VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) WELIREG (belzutifan) WINREVAIR (sotatercept-csrk) Animal Health BRAVECTO (fluralaner) BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension) NUMELVI (atinvicitinib) 1 All trademarks are property of their respective owners. 2 Net income attributable to the Company. 3 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. 4 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 and licensing arrangements. 5 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 both periods presented. Amount in the second quarter of 2025 also includes a $146 million benefit primarily resulting from favorable audit adjustments. Amount in the second quarter of 2024 also includes a $259 million 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 the 2019 federal tax return year. GAAP % Change GAAP % Change 2Q25 2Q24 June YTD 2025 June YTD 2024 $ 15,806 $ 16,112 -2% $ 31,335 $ 31,887 -2% 3,557 3,745 -5% 6,976 7,285 -4% 2,649 2,739 -3% 5,202 5,221 0% 4,048 3,500 16% 7,669 7,492 2% 560 80 * 629 202 * (7 ) 42 * (43 ) 12 * 4,999 6,006 -17% 10,902 11,675 -7% 571 545 1,388 1,447 4,428 5,461 -19% 9,514 10,228 -7% 1 6 8 11 $ 4,427 $ 5,455 -19% $ 9,506 $ 10,217 -7% $ 1.76 $ 2.14 -18% $ 3.77 $ 4.02 -6% 2,513 2,544 2,522 2,544 11.4 % 9.1 % 12.7 % 12.4 % $ 3,557 576 165 741 $ 2,816 2,649 15 1 16 2,633 4,048 3 53 56 3,992 560 560 560 – (7 ) (61 ) (61 ) 54 4,999 (594 ) (779 ) 61 (1,312 ) 6,311 571 (102 ) (3) (139 ) (3) 14 (3) (146 ) (4) (373 ) 944 4,428 (492 ) (640 ) 47 146 (939 ) 5,367 4,427 (492 ) (640 ) 47 146 (939 ) 5,366 $ 1.76 (0.20 ) (0.25 ) 0.02 0.06 (0.37 ) $ 2.13 11.4 % 15.0 % $ 6,976 1,196 201 1,397 $ 5,579 5,202 38 1 39 5,163 7,669 10 53 63 7,606 629 629 629 – (43 ) (3 ) (168 ) (171 ) 128 10,902 (1,241 ) (884 ) 168 (1,957 ) 12,859 1,388 (219 ) (3) (157 ) (3) 36 (3) (146 ) (4) (486 ) 1,874 9,514 (1,022 ) (727 ) 132 146 (1,471 ) 10,985 9,506 (1,022 ) (727 ) 132 146 (1,471 ) 10,977 $ 3.77 (0.40 ) (0.29 ) 0.05 0.06 (0.58 ) $ 4.35 12.7 % 14.6 % 2025 2024 2Q June YTD 1Q 2Q June YTD 1Q 2Q June YTD 3Q 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch % $15,529 $15,806 $31,335 $15,775 $16,112 $31,887 $16,657 $15,624 $64,168 -2 -2 -2 0 13,638 14,050 27,688 14,006 14,408 28,415 14,943 14,042 57,400 -2 -3 -3 -2 7,205 7,956 15,161 6,947 7,270 14,217 7,429 7,836 29,482 9 9 7 8 312 370 682 292 317 609 337 365 1,311 17 15 12 12 258 265 523 255 249 504 251 255 1,010 6 5 4 4 137 162 300 85 126 211 139 160 509 29 29 42 43 119 107 226 71 90 161 100 110 371 19 19 40 40 1,327 1,126 2,453 2,249 2,478 4,727 2,306 1,550 8,583 -55 -55 -48 -48 539 609 1,148 570 617 1,187 703 594 2,485 -1 -2 -3 -3 230 229 459 219 189 408 239 161 808 21 20 13 13 228 121 349 216 163 379 193 139 711 -26 -26 -8 -7 107 129 236 47 50 97 - - - - 41 38 79 61 59 120 68 74 263 -36 -37 -35 -33 441 461 902 440 455 895 420 449 1,764 1 1 1 1 208 228 436 174 188 362 208 215 785 21 20 20 21 83 96 179 73 92 165 96 79 340 5 5 8 9 70 74 145 56 62 118 64 70 252 21 21 23 24 280 336 615 70 70 149 200 419 106 123 229 98 106 203 102 109 415 16 16 12 12 68 80 147 70 72 142 72 73 287 10 6 4 4 102 83 185 350 110 460 383 121 964 -25 -27 -60 -59 90 86 176 111 89 200 102 92 394 -3 -4 -12 -11 67 83 150 56 60 116 65 69 249 40 35 30 30 45 41 86 42 39 81 42 40 163 5 4 6 6 50 40 90 46 53 99 78 45 222 -24 -26 -9 -8 184 172 356 189 543 -100 -100 -100 -100 39 35 74 41 114 -100 -100 -100 -100 549 372 921 419 405 824 278 232 1,334 -8 -8 12 13 247 251 498 251 224 475 204 255 935 12 14 5 8 729 584 1,313 632 618 1,252 638 699 2,590 -6 -7 5 6 1,588 1,646 3,234 1,511 1,482 2,993 1,487 1,397 5,877 11 11 8 11 924 961 1,885 850 837 1,686 886 889 3,462 15 16 12 16 664 685 1,349 661 645 1,307 601 508 2,415 6 6 3 4 303 110 413 258 222 479 227 185 891 -50 -3 -14 7 Media Contacts: Michael Levey michael.levey@msd.com Johanna Herrmann johanna.herrmann@msd.com Investor Contacts: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583

首款靶向IL-23口服多肽药物，或将上市！2025年7月21日，强生与Protagonist Therapeutics宣布已向美国FDA提交NDA，寻求批准其每日一次口服多肽疗法icotrokinra（JNJ-2113）上市，用于治疗12岁及以上中度至重度斑块状银屑病（PsO）成人与儿科患者。JNJ-2113是全球首款口服IL-23受体拮抗剂，原研是Protagonist。2021年，强生以9.8亿美元的交易总价从Protagonist手中拿到了两款IL-23在研产品的全球权益，JNJ-2113便是其中之一。可以预见，JNJ-2113的上市，或将改变现有银屑病治疗格局。临床数据优于上市疗法此次申请包括四项关键的3期临床研究数据，这些研究均为ICONIC临床开发项目的一部分（包括ICONIC-LEAD、ICONIC-TOTAL以及ICONIC-ADVANCE 1和ICONIC-ADVANCE 2）。JNJ-2113在上述3期研究中成功达成所有主要终点与共同主要终点，在12岁及以上中度至重度斑块状银屑病成人与儿科患者中，显示出显著的皮肤症状清除效果和良好的安全性。ICONIC-LEAD研究显示，JNJ-2113用药16周时，65%的患者达到IGA评分为0/1（皮肤症状清除或几乎清除），50%的患者达到PASI 90，而安慰剂组在这两个指标的数值分别仅为8%和4%。该研究的主要终点有两个，分别为：1）16周时达到研究者总体评估 IGA 0/1且评分变化>=2的受试者比例；2）16周时达到面积与严重程度指数PASI 90的受试者比例。到第24周，患者缓解率进一步提高，74%的患者达到IGA评分为0/1，46%达到IGA 0分；65%的患者达到PASI 90，40%达到PASI 100。在ICONIC-ADVANCE 1和2研究中，JNJ-2113显示出了优于已上市银屑病口服疗法氘可来昔替尼（deucravacitinib）的疗效。据悉，氘可来昔替尼是全球首个口服选择性TYK2抑制剂，由BMS研发。安全性方面，JNJ-2113整体耐受性良好。整合所有研究数据显示，治疗组（49.1%）与安慰剂组（51.9%）的不良事件发生率相似，目前尚未发现新的安全性信号。强生“专利悬崖”的困局从自身管线来看，强生堪称银屑病治疗领域的“领头羊”。公司旗下拥有乌司奴单抗、英夫利西单抗、戈利木单抗和古塞奇尤单抗等多款银屑病等自免领域的重磅产品，形成了覆盖广泛治疗需求的产品矩阵。其中，乌司奴单抗是当之无愧的百亿美元重磅单品，2024年全球销售额达103.6亿美元。然而，该药在美国的专利已于2023年9月到期，安进随即推出了生物类似药。强生通过法律手段阻挠了类似药的上市进程，但这只是缓兵之计。目前，三星生物、山德士、梯瓦、Biocon、Celltrion、百奥泰、费森尤斯等多家企业如雨后春笋般陆续获得相关批准，市场竞争压力日益加剧。目前的强生，核心产品乌司奴单抗正面临“专利悬崖”，销售额出现下滑趋势；而另一款古塞奇尤单抗的增长也趋于放缓。强生亟需一款新药接棒，以支撑其自身免疫疾病领域的产品格局。口服IL-23受体拮抗剂JNJ-2113的推进，正是强生巩固和扩大在银屑病治疗领域领先地位的重要一环。从市场需求来看，银屑病治疗领域潜力巨大。由于疾病进展缓慢，大多数患者需长期甚至终身治疗，庞大的患者基数与长期用药需求催生了一个数百亿美元级的市场。截至2023年6月的12个月内，全球银屑病药物市场规模约为340亿美元，占免疫疾病整体市场的30%左右。巩固银屑病的百亿市场，成了强生突破困境的首要任务之一。强生的破局之路——口服多肽随着疗效普遍提升，用药便捷性和患者依从性正成为影响治疗选择的关键因素。开发便捷、安全、高效的口服药物，已成为各大药企竞相争夺的“制高点”，尤其在慢性病长期管理中，口服剂型展现出显著的临床价值与市场潜力。其中，多肽类药物不仅继承了抗体类大分子药物高亲和力和高特异性的优势，还具备可通过化学方法合成、生产成本相对较低等优点，展现出良好的开发前景和商业化潜力。若能突破技术瓶颈，实现类似小分子药物的口服给药方式，则有望在保持其优异疗效的同时，大幅提升用药的便捷性和患者依从性，从而显著增强其临床价值和市场竞争力。近年来备受关注的GLP-1受体激动剂——司美格鲁肽（Semaglutide）便是一个典型案例。该药物原本需通过皮下注射给药，但诺和诺德借助“SNAC吸收促进剂”这一创新技术，成功开发出口服剂型Rybelsus，实现了GLP-1类药物通过口服途径给药的历史性突破，使Rybelsus成为全球首个真正意义上的口服多肽类药物。 而JNJ-2113的上市或将复刻这一路径，其依托Protagonist独有的多肽技术平台，成功突破了口服多肽类药物在生物利用度低、渗透性和稳定性差、以及易被胃肠道降解等方面的开发瓶颈。JNJ-2113能够以个位数皮摩尔级别的高亲和力结合IL-23R，并在人类T细胞中对IL-23信号通路展现出强效且选择性的抑制作用，具有显著的治疗潜力。为证明JNJ-2113的口服疗效，强生选择了自己“头对头”自己。该公司启动了一项III期ICONIC-ASCENDf研究，旨在证明口服药JNJ-2113优于注射生物制剂乌司奴单抗。除此之外，艾伯维也在积极布局银屑病口服药物领域，不久前收购了一家专注于开发口服多肽疗法的生物技术公司Nimble Therapeutics，并获得其核心资产，包括主打项目——口服肽类IL-23受体抑制剂，以及覆盖多种自身免疫疾病的创新口服肽候选药物管线。值得注意的是， IL-23靶点与艾伯维现有的重磅注射剂利生奇珠单抗相同，表明Nimble的研发方向与其现有产品线高度契合，具备显著的协同效应，有望实现从注射到口服治疗路径的顺利过渡。结语然而，口服多肽药物在开发与生产仍面临诸多挑战。多肽类药物通常结构复杂、稳定性差，对合成和生产的精度要求极高，在制备和储存过程中极易发生降解。相比传统小分子药物，多肽药物的生产成本更高，尤其是在确保其生物活性与稳定性方面，往往需要投入更多资源和技术支持。因此，如何在保障药物质量与活性的前提下，优化生产工艺、控制成本，并提升可扩展性，将是强生、艾伯维等企业在推进口服多肽疗法过程中必须面对和解决的关键问题。参考资料：1.Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis. Retrieved July 21, 2025 from https://www.prnewswire.com/news-releases/johnson--johnson-seeks-first-icotrokinra-us-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis-302509221.html2.银屑病潜在新兴疗法：多肽药物能否开辟“第三战场”？（药渡）3.银屑病药物研发管线与市场全景（小药说药）4.太卷了！强生口服银屑病新药公布III期积极顶线结果（药时代）5.银屑病正在迎来“生物制剂时代”（新药前沿）图片来源：豆包AI21.35亿美元！国产双靶点CAR-T出海2025-07-22又一款重磅COPD药物III期临床失败2025-07-21狂犬病疫苗卖不动了？“温州鞋王”退场2025-07-21版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩！