This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations.

Start Date07 Apr 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

[+1]

NCT06177912

/ CompletedPhase 3

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

Start Date18 Jan 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT05696080

/ CompletedPhase 3

A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease.

The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.

Start Date13 Feb 2023

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Pneumococcal 21-valent Conjugate Vaccine

100 Translational Medicine associated with Pneumococcal 21-valent Conjugate Vaccine

100 Patents (Medical) associated with Pneumococcal 21-valent Conjugate Vaccine

Literatures (Medical) associated with Pneumococcal 21-valent Conjugate Vaccine

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Health and economic impact of the 21-valent pneumococcal conjugate vaccine (V116) for adults in Japan: a delta price approach

Article

Author: Cassell, Kelsie ; Owusu-Edusei, Kwame ; Mueller, Peter P. ; Johnson, Kelly D. ; Tajima, Atsushi ; Cossrow, Nicole ; Yi, Zinan ; Matsuki, Taizo

INTRODUCTION:

This study analyzed the health and economic impact of the 21-valent pneumococcal conjugate vaccine (V116) and the 20-valent pneumococcal conjugate vaccine (PCV20), as well as their relative cost-effectiveness, in Japanese adults aged 65 years using a delta pricing approach.

METHODS:

A Markov model was employed to simulate the movement of the Japanese population among four health states: healthy, pneumococcal disease (consisting of invasive pneumococcal disease [IPD] with or without meningitis and non-bacteremic pneumococcal pneumonia [NBPP]), post-meningitis sequelae, and death. The model was populated with publicly available demographic and epidemiologic data, stratified by risk level. Pneumococcal serotype distribution and vaccine effectiveness, as well as direct and indirect treatment costs and health-related utilities, were derived from published sources. The model used a lifetime horizon and 2% discounting of costs and life-years. Costs were adjusted to 2023 values in Japanese yen (¥). Outcomes were cases and deaths, life-years and quality-adjusted life-years (QALYs), vaccination and treatment costs, and incremental cost-effectiveness ratios. The range over which V116 was cost-saving and cost-effective was determined.

RESULTS:

Compared to PCV20, V116 averted an additional 28 cases of IPD, 918 cases of NBPP, 5 deaths from IPD, and 51 deaths from NBPP over the lifetime of a single age 65 cohort. Life-years and QALYs gained were 1,019 and 642, respectively, relative to PCV20; V116 saved ¥733 million in direct medical costs and ¥557 million in indirect costs, compared to PCV20. V116 was found to be cost-saving at price premiums up to ¥1,322 (payer perspective) or ¥2,327 (societal perspective) and remained below a willingness-to-pay threshold of ¥5 million/QALY for premiums up to ¥7,113 (payer perspective) or ¥8,117 (societal perspective).

CONCLUSIONS:

V116 is projected to provide more population health benefits in Japan than PCV20, and to be cost-effective at a variety of price premiums.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Economic evaluation of PCV21 in vaccine-naïve adults aged 19–64 years with underlying medical conditions in the United States

Article

Author: Owusu-Edusei, Kwame ; Yi, Zinan ; Elbasha, Elamin H.

INTRODUCTION:

This study aimed to estimate the incremental health and economic outcomes associated with the use of PCV21 (Capvaxive) in vaccine-naive adults aged 19-64 years with underlying medical conditions in the United States (US).

METHODS:

A static multi-cohort state-transition Markov model was utilized, drawing on data from published literature and publicly available databases and reports, comparing PCV21 (intervention) versus PCV20 or PCV15 + PPSV23 (comparator) from a societal perspective with a lifetime horizon. The target population consisted of vaccine-naive adults aged 19-64 years classified as at-risk (AR) or high-risk (HR). Key outcome measures included undiscounted clinical cases: invasive pneumococcal disease (IPD), inpatient and outpatient non-bacteremic pneumococcal pneumonia (NBPP), post-meningitis sequelae (PMS), deaths from IPD and inpatient NBPP, as well as discounted quality-adjusted life years (QALYs), and total costs (in 2023 USD), with the incremental cost-effectiveness ratios (ICERs) reported as $/QALY gained. Costs and QALYs were discounted at 3% per year. Deterministic and probabilistic sensitivity analyses were conducted.

RESULTS:

The analysis indicated that the V116 strategy prevented a substantial number of cases and deaths compared to the PCV20 or PCV15 + PPSV23 strategies among vaccine-naive AR/HR adults aged 19-49 and 50-64 years. For instance, the use of PCV21 was projected to reduce IPD cases by 1,450 and 4,232, respectively, in the two age groups when compared with PCV20. The estimated ICERs for both age groups were found to be cost-saving when compared to both PCV20 and PCV15 + PPSV23. Deterministic and probabilistic sensitivity analyses confirmed the robustness of these findings, with over 95% of simulations yielding cost-saving results and all estimated ICERs remaining below $10,000/QALY gained.

CONCLUSIONS:

The findings suggest that the use of PCV21 (Capvaxive) in adults aged 19-64 years with underlying medical conditions in the US can prevent a significant number of pneumococcal disease cases and deaths while demonstrating favorable economic outcomes across various scenarios.

01 Aug 2025·VACCINE

A phase 3 randomized, double-blind clinical study to evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older

Article

Author: Grijalva, Carlos G ; Fernsler, Doreen ; Greenberg, David ; Weinberg, Aaron S ; Park, Jun ; Omole, Tosin ; Li, Jianing ; Orenstein, Walter A ; Platt, Heather L ; Euler, Danielle ; Azizad, Masoud

BACKGROUND:

Disease caused by Streptococcus pneumoniae is associated with considerable morbidity and mortality in adults. V116 is an approved 21-valent pneumococcal conjugate vaccine with a serotype composition designed to address the majority of residual pneumococcal disease in adults. This phase 3 study evaluated the safety, tolerability, and immunogenicity of V116 when administered concomitantly with quadrivalent influenza vaccine (QIV) in adults.

METHODS:

A total of 1080 healthy adults ≥ 50 years of age were randomized 1:1 to receive QIV and V116 concomitantly (n = 540) or QIV followed by V116 30 days later (n = 540). Immunogenicity was evaluated at 30 days postvaccination using opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) for V116, and hemagglutination inhibition (HAI) GMTs for QIV. For V116, the statistical criterion for noninferiority between groups required the lower bound of the 2-sided 95 % confidence interval of the OPA GMT ratio (concomitant/sequential groups) to be > 0.5. For QIV, the statistical criterion for noninferiority required the lower bound of the 2-sided 95 % CI of the HAI GMT ratio (concomitant/sequential groups) to be >0.67. Safety was evaluated by the proportion of participants with adverse events (AEs).

RESULTS:

The concomitant group met the primary noninferiority immunogenicity endpoints for 20 of 21 serotypes in V116 and for 3 of 4 influenza strains in QIV; noninferiority criteria were narrowly missed for serotype 23B and influenza H3N2. IgG GMCs at 30 days postvaccination were generally comparable between groups for all V116 serotypes. The proportions of participants with injection-site, systemic, vaccine-related, and serious AEs were generally comparable between groups.

CONCLUSIONS:

In adults ≥ 50 years of age, V116 is well tolerated and immunogenic when given concomitantly with QIV. Study results support use of V116 with QIV.

News (Medical) associated with Pneumococcal 21-valent Conjugate Vaccine

29 Jul 2025

·www.merck.com

Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2025 Financial Results

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

Phase 3Clinical ResultDrug ApprovalAcquisitionFinancial Statement

19 May 2025

·pmlive.com

Merck receives MHRA approval for adult-specific pneumococcal vaccine Capvaxive

Merck & Co – known as MSD outside the US and Canada – has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for its adult-specific pneumococcal vaccine Capvaxive. The vaccine has been authorised to help protect adults aged 18 years and older against illnesses caused by Streptococcus pneumoniae bacteria, including pneumonia and meningitis, which are currently considered a “major public health problem” by the World Health Organization (WHO). There are over 100 different types of pneumococcal bacteria and Merck’s Capvaxive, a single-dose 21-valent-vaccine, is specifically designed to help protect against the ones that are responsible for the majority of adult invasive pneumococcal disease. The MHRA’s decision on Capvaxive occurred through the International Recognition Procedure, a fast-track approval process that takes into account prior authorisations from other regulatory partners, and follows the European Commission’s approval of the vaccine in March. Among the evidence supporting the EU regulator’s decision were results from a phase 3 trial comparing Capvaxive to Pfizer’s 20-valent vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine. Capvaxive was shown to induce non-inferior immune responses compared to PCV20 for all ten serotypes common to both vaccines in adults aged 50 years and older, and generated superior immune responses for ten of its 11 unique serotypes. Merck’s vaccine was also shown to elicit non-inferior immune responses in adults aged 18 to 49 years compared to those aged 50 to 64 years and had a safety profile comparable to PCV20. “As with any medicine, the MHRA will keep the safety and effectiveness of this vaccine under close review,” the UK regulator said. Emma Cerrone, vaccines business unit director, MSD UK, said: “We are delighted with this decision. Pneumococcal infections can lead to serious complications requiring hospital treatment, however immunisation plays a vital role in prevention and can help adults live longer, healthier lives.” Alongside the EU, Capvaxive is approved in the US, Canada and Australia.

Drug ApprovalClinical ResultPhase 3Vaccine

24 Apr 2025

·www.fiercepharma.com

Merck ‘willing to work’ with Trump administration on price gap between US, international medicines

The company expects costs from tariffs that have so far been imposed to add up to about $200 million. With potential tariffs and other drug pricing policies on the horizon, the industry is navigating uncertain waters. Merck, while steadfast in its manufacturing push that aligns with the administration’s focus, is no different as it prepares for challenges ahead.While the company reaffirmed its full-year financial outlook of global sales between $64.1 billion and $65.6 billion in its first quarter earnings results, Merck noted that the number includes the hit of current tariffs that have been set in the U.S. That adds up to expected incremental costs of about $200 million, largely from those implemented between the U.S. and China, plus Canada and Mexico “to a lesser degree,” CEO Rob Davis explained on the company’s earnings call.President Donald Trump has not yet imposed tariffs specifically on pharmaceuticals, but with previous threats of pharma-targeted tariffs that could come in at 25% or more, it’s a concern that continues to cloud the industry. Merck, with more than $12 billion spent on U.S. manufacturing and R&D capabilities since 2018 and an additional $9 billion earmarked through 2028, has already been working on its supply chain strategy in a way that “aligns well with the new administration’s efforts to regrow the U.S. manufacturing base,” Davis noted. With its efforts so far, Merck has “done a good job of managing our inventory,” leaving the company “able to mitigate anything we could see in the short term,” the CEO said. For example, on-hand inventory for Keytruda in the U.S. will last through all of 2025, Davis said.Now, the focus is on gearing up for the medium and long-term. While the company made clear its business development strategy remains unchanged, the “uncertainty everyone is wrestling with” makes it “more complex to get things done,” Davis mused. An uncertain landscape One thing is for certain: uncertainty is the name of the game these days. With industry opposition to Europe’s low drug prices ramping up, especially as Trump reportedly considers an international drug pricing reference policy that would link U.S. drug prices to those of other countries, the higher prices and therefore greater incentive for innovation that the U.S. sees have been top of mind lately.“The price differential that exists between the United States and the rest of the world for our innovative medicines needs to be addressed,” Davis said, declaring Merck is “open and willing to work with the administration to do that.”As Merck and Davis see it, the focal areas in the drug pricing topic are pharmacy benefit manager (PBM) reform, “fair value” for innovation in other countries and protecting the “innovation engine” in the U.S.“We don't want to lose the leadership we have in this important field, and that's what we're trying to advocate for as we work with the administration,” he said.Elsewhere on the EU issue, Davis sided with “recent commentary” from his peers, some of whom, such as Novartis CEO Vas Narasimhan and Sanofi CEO Paul Hudson, have been outspoken about European drug pricing controls.“We have to continue to encourage foreign governments to understand that they need to give fair value for the innovation we bring,” at prices that “reward us for the risk in innovation that we have,” Davis said, adding that Merck is “spending time individually” and with its industry peers “promoting that point everywhere we can around the world.” Preparing for a post-Keytruda futureOutside of the industry-wide focus on tariffs and policy changes, the next few years will also be crucial for Merck as it prepares to lose exclusivity of its top-selling Keytruda. The megablockbuster oncology drug’s $7.2 billion in first quarter sales made up roughly half of the company’s total haul of $15.5 billion. As it stands, the plan is to use a pipeline of 20 potential growth drivers, “almost all of which have blockbuster potential,” to weather the storm and unlock over $50 billion by the mid-2030s, Davis said. New launches of pneumococcal disease vaccine Capvaxive and pulmonary arterial hypertension (PAH) drug Winrevair represent two of those 20 new products and have so far been delivering “meaningful contributions.”Winrevair specifically beat analysts' expectations at $280 million in first quarter sales, proving an “encouraging” launch so far, Citi Research analysts noted. More than 1,400 new patients received the drug over the quarter, while about 6,600 patients have been prescribed since its launch last April. The drug is going up against a hefty rival in Johnson & Johnson’s Uptravi, a prostacyclin receptor (IP) agonist that controlled half of the $7.3 billion market in 2023. But Merck is edging in on a group of patients whose background treatment does not include a prostacyclin with a “steady increase” in the percentage of prescriptions filled for that subset, the company pointed out.Meanwhile, a continuous headwind dragging down Merck’s sales is the sluggish demand for HPV vaccine Gardasil in China. With sales crashing 40% over the first quarter to $1.3 billion, the company doesn’t expect to ship further Gardasil products into China for the time being, Chief Financial Officer Caroline Litchfield noted. Excluding China, the vaccine’s sales swelled 14% over the quarter.

VaccineDrug Approval

100 Deals associated with Pneumococcal 21-valent Conjugate Vaccine

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pneumococcal Infections	United Kingdom	Merck Sharp & Dohme LLC	15 May 2025
invasive Streptococcus pneumoniae infection	European Union	Merck Sharp & Dohme BV	24 Mar 2025
invasive Streptococcus pneumoniae infection	Iceland	Merck Sharp & Dohme BV	24 Mar 2025
invasive Streptococcus pneumoniae infection	Liechtenstein	Merck Sharp & Dohme BV	24 Mar 2025
invasive Streptococcus pneumoniae infection	Norway	Merck Sharp & Dohme BV	24 Mar 2025
Invasive streptococcal disease	United States	Merck Sharp & Dohme LLC	17 Jun 2024
Pneumonia, Pneumococcal	United States	Merck Sharp & Dohme LLC	17 Jun 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	United States	Merck Sharp & Dohme Corp.	23 Sep 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05696080 (V116-008 \| STRIDE-8, CTgov)	Phase 3	Pneumococcal Infections	518	Placebo+V116 (V116 + Placebo)	ehnipymxgc = lbewsdodbd szbmfjorsz (qxtbizbkkj, astmyueukj - tonabojvom) View more	-	26 Feb 2025
				PPSV23+PCV15 (PCV15 + PPSV23)	ehnipymxgc = qkxjynsssh szbmfjorsz (qxtbizbkkj, veeoeyylvd - rvvpvsplxw) View more
NCT05569954 (V116-010 \| STRIDE-10, CTgov)	Phase 3	Pneumococcal Infections	1,484	V116 (V116)	khdtxpzhej = qntpujmcum mahshiazqf (repeijhfwb, klmnrfpoxy - aifzpztjrq) View more	-	31 Oct 2024
				PPSV23 (PPSV23)	khdtxpzhej = eggbwkyovp mahshiazqf (repeijhfwb, tfmdvifils - hbqxqeyglt) View more
NCT05526716 (V116-005 \| STRIDE-5, CTgov)	Phase 3	Pneumonia, Pneumococcal \| Influenza, Human	1,080	QIV+V116 (Concomitant Group (V116 + QIV Followed by Placebo))	pzehhbxgcw = tlwarcavjd prckvdpdub (elyhphuzlq, nfighlofyk - qgnahaviff) View more	-	05 Sep 2024
				QIV+V116 (Sequential Group (Placebo + QIV Followed by V116))	pzehhbxgcw = mcnnhfpjso prckvdpdub (elyhphuzlq, stuxwyjfvx - ezyiwmqclc) View more
NCT05420961 (V116-006 \| STRIDE-6, CTgov)	Phase 3	Pneumonia, Pneumococcal	717	V116 (Cohort 1: V116)	gbybvtowrf = qaoudqqrgm imkqxphicx (avdxbgxxkg, ckqcgjhrbx - yswxktuvpg) View more	-	01 May 2024
				PCV15 (Cohort 1: PCV15)	gbybvtowrf = elhkceayvt imkqxphicx (avdxbgxxkg, qorjqlwroi - pejwjtejal) View more
NCT05569954 (STRIDE-10, Biospace) Manual	Phase 3	Pneumococcal Infections	1,484	V116	gwzyrwhljg(lmhbzcnqpd) = V116 had a comparable safety profile to PPSV23. hpxdptlldv (gzololtmnz )	Non-inferior	29 Apr 2024
				PPSV23
NCT05393037 (STRIDE-7, Company_Website) Manual	Phase 3	Pneumococcal Infections	304	V116	aksdiovxmm(gswjjbyqru) = qchhzmdkve qhcrptlaqe (wowjiryjll )	Similar	19 Mar 2024
				PCV15+PPSV23	aksdiovxmm(gswjjbyqru) = xvtghjqfox qhcrptlaqe (wowjiryjll )
NCT05526716 (STRIDE-5, ISPPD2024) Manual	Phase 3	Pneumococcal Infections	1,080	concomitantly CAPVAXIVE+Quadrivalent Influenza Vaccine (QIV)	wfffttczqq(vstqlvypao) = The concomitant group met the primary immunogenicity endpoints for 20 of 21 serotypes in V116 (lower bound of the two-sided 95% confidence intervals for OPA GMT ratios [concomitant group/sequential group] >0.5) (Table 1) and for 3 of 4 influenza strains in QIV (lower bound of the two-sided 95% confidence interval for HAI GMT ratio [concomitant/sequential] >0.67). zahizaaqsy (pehgmzztls )	Positive	17 Mar 2024
				sequentially CAPVAXIVE+Quadrivalent Influenza Vaccine (QIV)
NCT05425732 (STRIDE-3, NEWS) Manual	Phase 3	Pneumonia, Pneumococcal \| Invasive streptococcal disease	-	V116 (50 岁及以上)	azovyzifxk(akuyhkqrah) = 在 50 岁及以上的成年人中（队列 1），与 PCV20 相比，V116 对两种疫苗中常见的全部10种血清型都能引起非劣效免疫反应。与50 - 64岁的成年人相比，在18 - 49岁的成年人(队列2)中，V116引发了非劣势免疫反应(免疫桥接)。 czzgeqofhk (qrbuccekdv ) View more	Positive	29 Nov 2023
				PCV20 (50 岁及以上)
NCT04665050 (Pubmed \| Hum Vaccin Immunother)	Phase 1	-	102	V116	ezasziemdu(xmimrqjlpx) = Comparable proportions vaccinated with V116 and PPSV23 experienced ≥1 solicited injection-site AE kaqtsbaqsj (ypoodogdgw ) View more	Positive	01 Aug 2023
				23-valent pneumococcal polysaccharide vaccine (PPSV23)
NCT05420961 (V116-006 \| STRIDE-6, Corporate Publications) Manual	Phase 3	Pneumonia, Pneumococcal \| IRAK4 Deficiency	717	V116	lqzvxibkwp(oigxcircat) = V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study kvuopguyzq (pbjrdecrnp ) Met	Positive	27 Jul 2023
				PCV15

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis