Company background
Merck & Co. (NYSE: MRK) was established in 1891 as the U.S. subsidiary of the German company E. Merck (now Merck KGaA), and became independent following World War I when U.S. assets were confiscated and sold. The company is headquartered in Rahway, New Jersey. Important corporate naming note: the U.S. Merck and the German Merck KGaA are two separate companies. Merck & Co. operates as MSD (Merck Sharp & Dohme) outside the U.S. and Canada to avoid confusion with the German Merck KGaA.
Robert Davis became CEO of Merck & Co. in July 2021 succeeding Kenneth Frazier (who served from 2011-2021 and led the company through the Keytruda commercial launch). Davis had been with Merck since 2014 as CFO before becoming CEO. He is managing the company through the Keytruda patent cliff preparation and the broader pipeline expansion.
The Keytruda franchise
Pembrolizumab (Keytruda). FDA-approved September 2014 as a treatment for advanced melanoma. The PD-1 immune checkpoint inhibitor unleashes the immune system's ability to recognize and attack cancer cells. Keytruda subsequently received FDA approval across approximately 40 cancer indications and combination therapies — substantially the most-approved cancer drug in modern oncology.
The commercial scale. Keytruda generated over $29 billion in 2024 revenue, making it the highest-revenue drug globally. The drug operates across non-small cell lung cancer, melanoma, head and neck cancer, Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancers, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial cancer, triple-negative breast cancer, and additional indications.
The patent cliff. U.S. patent expiration arrives in 2028. The post-patent biosimilar competition is expected to substantially compress Keytruda revenue. Merck has pursued multiple strategies to address the cliff — subcutaneous formulation development (which would extend exclusivity), expansion of approved indications, and substantial pipeline acquisition.
The post-Keytruda pipeline strategy
The Prometheus Biosciences acquisition (June 2023). Merck completed its $10.8 billion acquisition of Prometheus Biosciences in June 2023, bringing PRA023 (now MK-7240) into the immunology pipeline. The drug targets TL1A for inflammatory bowel disease — ulcerative colitis and Crohn's disease.
The Acceleron acquisition (November 2021). Merck completed the $11.5 billion acquisition of Acceleron Pharma, bringing sotatercept into the pipeline. Subsequently approved as Winrevair (FDA approval March 2024) for pulmonary arterial hypertension.
The Daiichi Sankyo collaboration (October 2023). Merck and Daiichi Sankyo entered a $22 billion collaboration on three antibody-drug conjugates (ADCs) — patritumab deruxtecan, ifinatamab deruxtecan, and raludotatug deruxtecan. The deal anchored Merck's ADC strategy alongside its broader oncology pipeline expansion.
The Harpoon Therapeutics acquisition (January 2024). Approximately $680 million acquisition expanding the T-cell engager portfolio.
The EyeBio acquisition (May 2024). Approximately $1.3 billion acquisition expanding the ophthalmology pipeline.
The broader Merck portfolio
Gardasil/Gardasil 9. The HPV vaccine — the second-largest Merck product after Keytruda. Substantial sustained growth through international expansion, particularly in China before the 2024-2025 demand compression.
Lagevrio (molnupiravir). Oral COVID-19 antiviral developed in partnership with Ridgeback Biotherapeutics. FDA EUA December 2021.
Bridion (sugammadex). Reversal agent for neuromuscular blockade during surgery.
Welireg (belzutifan). HIF-2α inhibitor for von Hippel-Lindau disease and renal cell carcinoma.
Animal Health. Merck Animal Health operates substantial veterinary pharmaceutical and vaccine business — Bravecto, Nobivac, and broader portfolio.
The Organon spinoff (June 2021). Merck completed the spinoff of women's health and biosimilars business as Organon (NYSE: OGN). The spinoff allowed Merck to focus on oncology, vaccines, and infectious disease while Organon operates the established-products portfolio independently.
How Merck operates communications
Merck's communications strategy navigates several distinctive challenges. The sustained Keytruda commercial cycle requires ongoing oncology trade press engagement, sustained clinical-trial communications across approximately 40 cancer indications, and broader scientific affairs work that supports the franchise. The patent cliff communications work — explaining the post-Keytruda revenue trajectory, the pipeline acquisitions, and the broader strategic positioning — has been the dominant CFO and IR communications challenge through 2023-2026. The pricing and IRA Medicare negotiation pressure — Merck's Januvia (sitagliptin) was among the first drugs selected for Medicare price negotiation under the Inflation Reduction Act, anchoring sustained federal policy engagement.
Robert Davis has operated a less-visible CEO communications posture than peers like Albert Bourla at Pfizer. Merck's communications operation has historically emphasized scientific affairs and trade press engagement over consumer-facing CEO visibility.
The competitive position
Merck competes primarily across oncology (against Bristol Myers Squibb's Opdivo, Roche's portfolio, AstraZeneca's Imfinzi, Pfizer's expanding oncology franchise), vaccines (against Pfizer, GSK, Sanofi), and the broader pharmaceutical cohort across distinct categories. The Keytruda-Opdivo competition has anchored sustained oncology trade press attention since 2014-2015 and continues to shape PD-1/PD-L1 category dynamics through 2026.
Established in 1891 as the U.S. subsidiary of German Merck (now Merck KGaA). Became independent following World War I when U.S. assets were confiscated and sold. Headquartered in Rahway, New Jersey.
Is Merck & Co. the same as Merck KGaA?
No. The U.S. Merck & Co. and the German Merck KGaA are two separate companies. Merck & Co. operates as MSD (Merck Sharp & Dohme) outside the U.S. and Canada to avoid naming confusion.
Who is the CEO of Merck & Co.?
Robert Davis, CEO since July 2021. Previously CFO. Succeeded Kenneth Frazier (CEO 2011-2021, who led the company through the Keytruda commercial launch).
What is Keytruda?
Pembrolizumab, the PD-1 immune checkpoint inhibitor. FDA-approved September 2014 for advanced melanoma. Subsequently approved across approximately 40 cancer indications. The highest-revenue drug globally — over $29 billion in 2024 revenue.
When does Keytruda lose patent protection?
U.S. patent expiration arrives in 2028. Post-patent biosimilar competition expected to substantially compress revenue. Merck pursuing subcutaneous formulation, indication expansion, and substantial pipeline acquisition to address the cliff.
What was the Prometheus Biosciences acquisition?
Merck's $10.8 billion June 2023 acquisition bringing PRA023 (now MK-7240) into the immunology pipeline. The drug targets TL1A for inflammatory bowel disease.
What is Gardasil?
Merck's HPV vaccine — the second-largest Merck product after Keytruda. Substantial sustained growth through international expansion, particularly in China before the 2024-2025 demand compression.
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