10-QPeriod: Q3 FY2025

Merck & Co., Inc. Quarterly Report for Q3 Ended Sep 30, 2025

Filed November 5, 2025For Securities:MRK

Summary

Merck & Co., Inc. reported a strong financial performance for the third quarter and first nine months of 2025, with total sales reaching $17.3 billion and $48.6 billion, respectively. This represents a 4% increase year-over-year for the quarter and a slight increase for the nine-month period. The company experienced significant growth in its Pharmaceutical segment, driven by Keytruda, Welireg, and alliance revenues from Lynparza and Lenvima, alongside the cardiovascular franchise boosted by the Winrevair launch. The Animal Health segment also showed robust growth. Despite strong sales, R&D expenses saw a notable decrease of 28% in Q3 and 11% year-to-date, primarily due to reduced business development activity compared to the prior year's significant acquisition-related charges. The company also initiated a new restructuring program expected to yield substantial cost savings. Key strategic moves during the period include the significant acquisition of Verona Pharma for approximately $10.5 billion, bolstering the respiratory disease portfolio with Ohtuvayre, and entering a funding arrangement with Blackstone for the development of sacituzumab tirumotecan. These strategic investments underscore Merck's commitment to expanding its therapeutic reach. While overall sales show positive momentum, the company faces ongoing pricing pressures and evolving regulatory landscapes, particularly from the Inflation Reduction Act's drug price negotiation program impacting products like Januvia and Janumet. Legal proceedings, including the Gardasil litigation, continue, though a proposed agreement to resolve the bulk of pending claims was reached, which is expected to be not material to Merck.

Financial Statements
Beta

Key Highlights

  • 1Total sales increased by 4% to $17.3 billion in Q3 2025 and were flat at $48.6 billion for the first nine months of 2025 compared to the prior year.
  • 2Significant strategic acquisition of Verona Pharma for ~$10.5 billion completed in October 2025, strengthening the respiratory portfolio with Ohtuvayre.
  • 3Research and Development (R&D) expenses decreased by 28% in Q3 and 11% year-to-date due to reduced business development charges compared to the prior year.
  • 4Keytruda sales grew by 10% in Q3 and 8% year-to-date, driven by new indications and increased utilization across various cancer types.
  • 5The company initiated a new $3.0 billion restructuring program (2025 Restructuring Program) expected to yield ~$1.7 billion in annual cost savings by the end of 2027.
  • 6Gardasil/Gardasil 9 sales declined significantly due to paused shipments to China amid elevated inventory levels.
  • 7A proposed agreement to substantially resolve the majority of pending Gardasil product liability claims in the U.S. was reached, expected to be not material to Merck.

Frequently Asked Questions

Sales growth was primarily driven by the Pharmaceutical segment, with strong performance from Keytruda, Welireg, and alliance revenues from Lynparza and Lenvima. The Cardiovascular franchise benefited from the Winrevair launch. The Animal Health segment also demonstrated robust growth. These increases were partially offset by declines in vaccines, immunology, and virology, notably due to lower Gardasil/Gardasil 9 sales.

The acquisition of Verona Pharma for approximately $10.5 billion in October 2025 significantly strengthens Merck's respiratory disease portfolio by adding Ohtuvayre (ensifentrine). While the transaction is substantial, it is expected to be accreted to earnings and is a key part of Merck's strategy to expand its therapeutic reach.

Merck is actively managing the impact of the IRA. Januvia was selected for the first year of the drug price negotiation program, with a government-set price effective January 1, 2026. Janumet and Janumet XR were selected for the second year, effective January 1, 2027. Merck has also sued the U.S. government regarding the IRA's drug price negotiation program, believing it will negatively impact future sales and profitability of key products. The company is also working to mitigate pricing pressures through strategies like lowering list prices on certain products.

Sales of Gardasil/Gardasil 9 declined significantly due to paused shipments to China resulting from elevated inventory levels with the distributor. While this has caused a substantial decline in sales for 2025, Merck has also obtained new approvals for these vaccines in China and Japan. The company is also implementing a proposed agreement to resolve the majority of pending Gardasil product liability claims in the U.S., which is expected to have a not material impact on Merck's financial condition.