Merck & Co. (MRK) Company Report

Total revenues of $16.4 billion in Q4 2025, up 5% ex-FX, driven by Keytruda sales of $8.4 billion (+5%) and Welireg sales of $220 million (+37%).
Guidance for 2026 reiterates expected sales growth led by new launches in oncology and animal health, despite a $2.5 billion headwind from generics, with ≈$3 billion in share repurchases planned.
Pipeline and M&A: Acquisitions of Verona Pharma and Cidara Therapeutics position Merck for over $70 billion of mid-2030s commercial opportunity—$20 billion above last year’s estimate—across respiratory, infectious disease, and oncology.
Clinical progress includes positive Phase III results for Enlicitide, expanded EU approval for Winrevair, and upcoming 2026 readouts for Islatravir + Lenacapavir, MK-3000, and Tulisokibart.

7 hours ago

Transcript

Merck reports Q4 2025 results

MRK

Earnings

M&A

Guidance Update

Q4 revenues of $16.4 billion, up 5% (4% ex-FX), driven by oncology and animal health, with Keytruda sales rising 5% to $8.4 billion
Welireg sales grew 37% to $220 million, while Gardasil declined 35% to $1 billion, and Winrevair generated $467 million in cardiometabolic and respiratory
2026 outlook expects growth from new product launches, continued oncology and animal health strength, despite headwinds of $2.5 billion from generics, IRA pricing, and a $3 billion share repurchase plan
Completed acquisitions of Verona Pharma and Cidara Therapeutics, expanding a pipeline with > $70 billion of mid-2030s commercial opportunity from 20+ new growth drivers

7 hours ago

Transcript

Merck reports Q4 2025 results

MRK

Earnings

M&A

Product Launch

Merck delivered $16.4 billion in Q4 revenues, up 5% ex-FX, driven by strong oncology and new product launches.
Keytruda family sales rose 5% to $8.4 billion, with Keytruda QLEX contributing $35 million, while Welireg grew 37% to $220 million.
Vaccine performance was mixed: Gardasil fell 35% to $1 billion, Capvaxive pneumococcal vaccine reached $279 million, Enflonsia RSV mAb posted $21 million, and Winrevair achieved $467 million globally.
Pipeline progress included phase 3 success for Enlicitide, positive phase 2 results for Winrevair and Islatravir, and completion of Verona Pharma and Cidara Therapeutics acquisitions to expand respiratory and infectious disease franchises.

8 hours ago

Transcript

Merck & Co. receives Priority Review for DATROWAY as 1st-line TNBC treatment

MRK

Product Launch

DATROWAY® (datopotamab deruxtecan-dlnk) has been granted Priority Review by the FDA as a 1st-line treatment for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for immunotherapy, with an action date anticipated in Q2 2026 under Project Orbis.
The Phase III TROPION-Breast02 trial demonstrated a 5.0-month improvement in median overall survival (HR 0.79; 95% CI 0.64–0.98; p=0.0291) and a 43% reduction in risk of disease progression or death (HR 0.57; 95% CI 0.47–0.69; p<0.0001) versus chemotherapy.
DATROWAY achieved an objective response rate of 62.5% and a duration of response of 12.3 months, compared with 29.3% ORR and 7.1 months DoR for chemotherapy.
Approximately 70% of metastatic TNBC patients are ineligible for PD-1/PD-L1 immunotherapy, leaving chemotherapy as the only approved first-line option; if approved, DATROWAY could become the new standard of care.

11 hours ago

Press Release

Merck reports Q4 2025 earnings

MRK

Earnings

Guidance Update

M&A

Q4 sales of $16.4 B (+5% nominal, +4% ex-FX) and non-GAAP EPS of $2.04 (+19%)
2026 guidance: revenue of $65.5 B–$67.0 B (+1–3% nominal; +0–2% ex-FX) and non-GAAP EPS of $5.00–$5.15
KEYTRUDA family sales of $8.4 B (+5%), driven by earlier-stage and new combination indications
Completed acquisition of Cidara Therapeutics, adding MK-1406 antiviral with >$5 B potential; pipeline now includes ~80 Phase 3 studies
WINREVAIR sales reached $467 M and Animal Health grew 6% to $1.6 B, reflecting portfolio diversification

12 hours ago

Presentation

Merck announces Q4 and full-year 2025 financial results

MRK

Earnings

Guidance Update

Fourth-quarter 2025 worldwide sales were $16.4 B (5% growth) with GAAP EPS of $1.19 and non-GAAP EPS of $2.04.
Full-year 2025 worldwide sales reached $65.0 B (1% growth) with GAAP EPS of $7.28 and non-GAAP EPS of $8.98.
Key product highlights include KEYTRUDA sales of $31.7 B (+7%) and Animal Health sales of $6.4 B (+8%) in 2025.
2026 outlook: anticipates sales of $65.5–67.0 B and non-GAAP EPS of $5.00–5.15, reflecting one-time charges related to the Cidara acquisition.

12 hours ago

Press Release

Merck & Co. announces Q4 and FY 2025 results and 2026 outlook

MRK

Earnings

Guidance Update

M&A

Merck reported Q4 2025 sales of $16.4 B (5% nominal; 4% ex-FX), with GAAP EPS of $1.19 and non-GAAP EPS of $2.04.
Full-year 2025 sales were $65.0 B (1% nominal; 2% ex-FX), delivering GAAP EPS of $7.28 and non-GAAP EPS of $8.98.
The company forecasts 2026 sales of $65.5–67.0 B and non-GAAP EPS of $5.00–5.15, reflecting a one-time charge for the acquisition of Cidara.
Portfolio expanded by acquiring Verona Pharma and Cidara Therapeutics and licensing agreements with Hengrui Pharma; completed the Cidara deal for about $9.2 B in 2026.
Advanced its pipeline with 18 positive Phase 3 trial results in 2025 and received FDA priority vouchers for enlicitide and sac-TMT.

12 hours ago

8-K

Merck & Co. receives FDA priority review for DATROWAY in metastatic TNBC

MRK

Product Launch

The FDA accepted and granted Priority Review to Daiichi Sankyo/AstraZeneca’s sBLA for DATROWAY® as a first-line treatment in unresectable or metastatic triple negative breast cancer patients ineligible for immunotherapy, with a PDUFA date of June 2, 2026.
Phase 3 TROPION-Breast02 data showed a 5.0-month improvement in median overall survival (HR 0.79; p=0.0291) and a 43% reduction in risk of progression or death (HR 0.57; p<0.0001) versus chemotherapy.
DATROWAY achieved an objective response rate of 62.5% and median duration of response of 12.3 months, compared with 29.3% ORR and 7.1 months DoR for chemotherapy, supporting its potential as a new standard of care.
The submission is being reviewed under Project Orbis, enabling concurrent regulatory review with international partners.

16 hours ago

Press Release

Merck & Co. highlights growth in global melanoma diagnostics and therapeutics market

MRK

Market projected to expand from USD 7.66 billion in 2025 to USD 13.81 billion by 2031 at a 10.32% CAGR
Growth driven by rising melanoma incidence (approx. 104,960 new invasive cases in the US in 2025) and an aging population, sustaining demand for early detection and advanced treatments
High treatment costs (e.g., $47,538/month for checkpoint inhibitors in 2024) and reimbursement hurdles constrain market access and penetration
Uptake of personalized therapies is accelerating: Tumor-Infiltrating Lymphocyte cell therapies netted $42.1 million in Q3 2024, and the mRNA-4157/Keytruda combo cut death or recurrence risk by 49% in high-risk patients

5 days ago

Press Release

Merck & Co. reports 49% reduction in melanoma recurrence with personalized mRNA vaccine

MRK

New Projects/Investments

Phase 2b KEYNOTE-942 five-year follow-up shows 49% reduction in risk of melanoma recurrence or death with intismeran plus Keytruda versus Keytruda alone
Intismeran (mRNA-4157/V940) encodes up to 34 patient-specific neoantigens, matching three-year efficacy and underscoring treatment durability
Fully enrolled pivotal phase 3 program underway, with an interim readout expected in 2026, alongside larger trials in lung, bladder and kidney cancers
Moderna projects intismeran as a potential growth driver for 2027 commercialization, contingent on later-stage results

Jan 20, 2026, 11:37 AM

Bloomberg