Short answer
Merck & Co. (MRK) filed its fiscal 2025 10-K annual report with the SEC on Feb 24, 2026. It reported revenue of $65.0B (+1.3% year over year) and net income of $18.3B.
- Top risk flagged: IRA price setting: Keytruda (49% of total 2025 sales) expected selected by HHS in 2027, government price effective Jan 1, 2029, U.S. sales to decline materially
FY2025 key financial metrics · XBRL
- Revenue
- $65.0B
- +1.3% YoY
- Net income
- $18.3B
- +6.6% YoY
- EPS (diluted)
- $7.28
- +8.0% YoY
- ROE
- 34.7%
- −2.3 pp YoY
- Operating cash flow
- $16.5B
- −23.3% YoY
Source: XBRL data from the Merck & Co. (MRK) FY2025 10-K on SEC EDGAR. USD.
Merck & Co. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Global pharma/animal health company; Pharmaceutical segment (89% of sales) anchored by Keytruda immunotherapy franchise generating $31.7B in FY2025
- Keytruda Qlex (subcutaneous pembrolizumab) launched in 2025; FDA-approved September 2025 across most adult solid tumor indications: new formulation extending franchise runway beyond 2028 Keytruda compound patent expiry
- Gardasil revenue collapsed to $5.2B from $8.6B (-39% YoY) driven by China market contraction; Winrevair (PAH) debuted at $1.4B vs zero in 2024, partially offsetting Gardasil decline
- ~75,000 employees globally as of Dec 31, 2025; US international sales mix shifted to 56% domestic / 44% international vs 50/50 in 2024, reflecting China Gardasil erosion
- December 2025: Merck signed a "Most-Favored-Nation" agreement with the US government; committing to direct-to-patient pricing, Medicaid discounts, and MFN-linked launch pricing for new products in exchange for a 3-year Section 232 tariff delay on manufacturing imports
Management Discussion & Analysis
- Revenue $65.0B in 2025, up 1% YoY (+2% ex-FX) from $64.2B; US sales +13% to $36.5B, international -11% to $28.5B
- Gross margin 74.8% vs 76.3% in 2024; GAAP EPS $7.28 vs $6.74; non-GAAP EPS $8.98 vs $7.65
- Best segment: Pharmaceutical (Keytruda/Keytruda Qlex $31.7B, +7%; Welireg +41%); worst: Vaccines, with Gardasil/Gardasil 9 -39% to $5.2B on China demand collapse
- Operating cash flow $16.5B (vs $21.5B in 2024); capex $4.1B; dividends $8.2B; buybacks $5.1B (~59M shares); quarterly dividend raised to $0.85/share
- Key risks: Keytruda IRA government price-setting effective 2029, Januvia/Janumet US exclusivity loss May/Jul 2026, $9.2B Cidara acquisition closing Jan 2026 with ~$9.0B R&D charge expected Q1 2026
Risk Factors
- IRA price setting: Keytruda (49% of total 2025 sales) expected selected by HHS in 2027, government price effective Jan 1, 2029, U.S. sales to decline materially
- Gardasil/Gardasil 9 China shipments paused since Feb 2025; local competitor's nine-valent HPV vaccine approved June 2025 for females 9-45 years
- Keytruda biosimilar competition expected Dec 2028 when primary compound patent expires, with European market exclusivity lost 2031
- Bridion loses U.S. exclusivity July 2026; Januvia/Janumet loses exclusivity May 2026; Company expects to lose "nearly all" U.S. Januvia/Janumet sales thereafter
- IRS examining 2017-2018 tax returns including TCJA one-time transition tax position; adverse outcome described as potentially material to cash flows
Generated from the filing text; verify against the original. How to read a 10-K
Other Merck & Co. annual reports
Ask about this 10-K
Compare years, dig into a risk factor or check the numbers against insider trades and fund holders.