Merck & Co Stock Price, News & Analysis

Merck (MRK) reported Q1 2025 financial results with total worldwide sales of $15.5 billion, showing a 2% decrease from Q1 2024, though growing 1% excluding foreign exchange impact.

Key performance highlights include:

• KEYTRUDA sales grew 4% to $7.2 billion
• WINREVAIR achieved sales of $280 million
• Animal Health sales increased 5% to $1.6 billion
• GARDASIL/GARDASIL 9 sales declined 41% to $1.3 billion

The company reported GAAP EPS of $2.01 and Non-GAAP EPS of $2.22. For full-year 2025, Merck expects worldwide sales between $64.1-65.6 billion and revised Non-GAAP EPS to $8.82-8.97, reflecting a one-time charge related to the Hengrui Pharma agreement and additional tariff costs of $200 million.

Merck (NYSE: MRK) has scheduled its first-quarter 2025 sales and earnings conference call for Thursday, April 24, at 9:00 a.m. ET. The call will feature company executives presenting an overview of Merck's quarterly performance to institutional investors and analysts.

Participants can access the live audio webcast through a provided weblink, with a replay available later at www.merck.com along with the earnings release, supplemental financial disclosures, and results slides. Interested parties can also join via phone using the toll-free number (800) 369-3351 for U.S. and Canada, or (517) 308-9448, with access code 9818590.

Merck (NYSE: MRK) announced groundbreaking results from the Phase 3 ZENITH trial of WINREVAIR™ for pulmonary arterial hypertension (PAH). The study demonstrated a 76% reduction in the risk of major morbidity and mortality events compared to placebo in adults with PAH WHO functional class III or IV at high risk.

At median follow-up of 10.6 months, only 17.4% of WINREVAIR-treated patients experienced major events versus 54.7% in the placebo group. The trial was stopped early due to overwhelming efficacy. Key outcomes included:

• Deaths: 8.1% WINREVAIR vs 15.1% placebo
• Lung transplantation: 1.2% WINREVAIR vs 7.0% placebo
• PAH hospitalizations: 9.0% WINREVAIR vs 50.0% placebo

The safety profile remained consistent with previous studies, with no treatment discontinuations due to adverse events. WINREVAIR is currently approved in over 40 countries based on previous STELLAR trial results.

Merck (MRK) announced positive results from the pivotal Phase 3 trial evaluating subcutaneous pembrolizumab with berahyaluronidase alfa versus intravenous (IV) KEYTRUDA in metastatic non-small cell lung cancer treatment.

Key findings include:

• Noninferior pharmacokinetics demonstrated for subcutaneous administration
• Consistent efficacy and safety profile compared to IV KEYTRUDA
• Median injection time of just two minutes for subcutaneous delivery
• 49.7% reduction in patient chair time and 47.4% reduction in treatment room time
• 45.7% reduction in healthcare professional active time

The FDA has set a PDUFA date of Sept. 23, 2025, for the Biologics License Application review. The European Medicines Agency has also validated an extension application for this new administration route.

Merck (NYSE: MRK) has received European Commission (EC) approval for CAPVAXIVE®, a 21-valent pneumococcal conjugate vaccine for adults aged 18 and older. The vaccine is designed to prevent invasive pneumococcal disease and pneumonia caused by 21 specific Streptococcus pneumoniae serotypes.

The approval, based on the Phase 3 STRIDE clinical program, covers all 27 EU member states, Iceland, Liechtenstein, and Norway. This marks CAPVAXIVE's fourth regulatory approval, following authorizations in the U.S. (June 2024), Canada (July 2024), and Australia (January 2025).

Clinical data demonstrated that CAPVAXIVE was non-inferior to existing vaccines (PCV20 and PPSV23) for shared serotypes and showed superiority for unique serotypes. The vaccine exhibited comparable safety profiles to other pneumococcal vaccines across multiple clinical trials, including studies with immunocompromised patients and those receiving concurrent influenza vaccination.

Merck (NYSE: MRK) has entered into an exclusive license agreement with Jiangsu Hengrui Pharmaceuticals for HRS-5346, an investigational oral Lipoprotein(a) inhibitor for cardiovascular disease. The deal grants Merck exclusive rights to develop, manufacture, and commercialize HRS-5346 worldwide, except in the Greater China region.

Key financial terms include:

• $200 million upfront payment to Hengrui
• Up to $1.77 billion in potential milestone payments
• Royalties on net sales if approved

HRS-5346 is currently in Phase 2 clinical trials in China. The transaction is expected to close in Q2 2025, subject to Hart-Scott-Rodino Antitrust approval. Merck anticipates recording a pre-tax charge of $200 million ($0.06 per share) in both GAAP and non-GAAP results upon closing.

Merck (MRK) announced new clinical and outcomes research data presentations at the American College of Cardiology's Annual Scientific Session (ACC.25) in Chicago, March 29-31. The highlight is the Phase 3 ZENITH trial results for WINREVAIR™ (sotatercept-csrk) in treating pulmonary arterial hypertension (PAH) patients, which concluded early due to overwhelming efficacy.

The company will present four outcomes research presentations on cholesterol management, including real-world data on healthcare utilization costs for dyslipidemia treatment and LDL-C measurement patterns. Research focuses on barriers to achieving LDL-C goals, noting that nearly two-thirds of individuals don't reach their targets. The presentations include a systematic review of residual atherosclerotic cardiovascular disease risk in statin users and a model estimating the impact of lipid-lowering therapy treatment patterns.

Merck (NYSE: MRK) announced positive results from two Phase 3 trials of its investigational once-daily oral two-drug regimen doravirine/islatravir (DOR/ISL) for HIV-1 treatment. The trials demonstrated non-inferiority to existing therapies in maintaining viral suppression at Week 48.

Key findings from the trials:

• In MK-8591A-052 trial: 1.5% of DOR/ISL patients had viral load ≥50 copies/mL vs 0.6% on BIC/FTC/TAF, with 91.5% maintaining viral suppression
• In MK-8591A-051 trial: 1.4% of DOR/ISL patients had viral load ≥50 copies/mL vs 4.9% on baseline antiretroviral therapy, with 95.6% maintaining viral suppression

The safety profile was comparable to existing treatments, with no treatment-emergent resistance observed. Merck plans to submit applications for marketing authorization by mid-2025.

Merck (MRK) has unveiled a new $1 billion, 225,000-square-foot vaccine manufacturing facility in Durham, North Carolina. This expansion is part of the company's broader $12 billion U.S. capital investment initiative since 2018, with an additional $8 billion planned by 2028.

The state-of-the-art facility incorporates advanced technologies including data analytics, generative AI, 3D printing, and a digital twin training center for simulating manufacturing processes. This investment demonstrates Merck's commitment to expanding domestic manufacturing and R&D capabilities while creating new jobs in the United States.