Merck & Co., Inc. (MRK) Risk Factors
Health CareLatest 10-K filed Feb 24, 2026Source: SEC EDGAR
WealthWire extracted and classified 30 risk factors from Merck & Co., Inc.’s latest SEC filing, mapping each to a standardized risk taxonomy so they can be compared across every company and sector. The breakdown below shows how those disclosures distribute across risk categories.
Market & business
9 factorsLegal & regulatory
8 factorsOperations & people
4 factorsESG & reputation
3 factorsTechnology
3 factorsFinancial
2 factorsHealthcare & life sciences
1 factorsRecent key developments
Concrete developments — dated events, named agreements and instruments, legal proceedings — that Merck & Co., Inc. surfaced in its latest filing.
- Sales of Gardasil/Gardasil 9 in China were significantly lower in 2025 and are not expected to materially increase in 2026.2025
- Shipments of Gardasil/Gardasil 9 to China were paused beginning February 2025 due to high inventory at commercialization partner and have not resumed.February 2025
- In June 2025, a nine-valent HPV vaccine produced by a local manufacturer received regulatory approval in China.June 2025
- HHS selected Januvia for IRA price setting with government-set price effective January 1, 2026.2023
- In 2025, HHS selected Janumet and Janumet XR for government price setting, effective January 1, 2027.2025
- In January 2026, HHS announced Lenvima selected for government price setting, effective January 1, 2028.January 2026
- Company expects HHS to include Keytruda in 2027 IRA price setting with price effective January 1, 2029, and expects U.S. Keytruda sales to decline materially after that time.2027
- In December 2025, the Company entered into the MFN Agreement with the U.S. government to provide key products through a direct-to-patient program at affordable prices.December 2025
- Increased utilization of the 340B Federal Drug Discount Program negatively affected 2025 sales performance.2025
- IRS is currently conducting examinations of the Company’s tax returns for 2017 and 2018, including the one-time transition tax under the TCJA.
- IRS is conducting examinations of the Company’s tax returns for 2021 and 2022.
- The Company has taken the position that its distribution of Organon & Co. common stock in the 2021 spin-off qualifies as tax-free for U.S. federal income tax purposes based on opinions of tax counsel.2021
- Product safety and liability litigation involving Gardasil.
- Legal matters detailed in Note 10 to the Financial Statements.
- The company is beginning a multi-year system upgrade of its SAP system.
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