Merck looks to cardiovascular pipeline for $10B-plus peak sales—and diversification from Keytruda

Under pressure to diversify from the blockbuster cancer med Keytruda, Merck & Co. is looking to its cardiovascular portfolio in hopes of finding $10 billion in peak revenue by the mid-2030s—depending on the approval of eight potential therapies.

Over the past year, the company’s late-stage cardiovascular pipeline has tripled in size via internal advancements and business development, Merck executives said during an investor event Tuesday. The biopharmaceutical giant is focusing on areas with greatest need and the largest patient impact opportunities, such as heart failure, pulmonary arterial hypertension (PAH), thrombosis and atherosclerosis, according to Dean Li, M.D., Ph.D., president of Merck Research Laboratories.

All new approvals are expected by 2030 and include sotatercept (MK-7962), a PAH drug Merck procured in its $11.5 billion acquisition of Acceleron Pharma, which closed in November 2021. Sotatercept is being tested in a phase 3 trial as an add-on to current standard of care for PAH, and, if approved, would be the first non-vasodilator with the potential to address underlying disease. The study's anticipated primary completion date is December 2022, Merck officials said.

Also in Merck’s PAH portfolio is the once-daily inhaled therapy MK-5475. Preclinical proof-of-concept trials showed a targeted reduction in vascular resistance and pressure, and the drug has moved on to a phase 2/3 study.

If both are approved, MK-7962 and MK-5475 could be used in conjunction with other medicines or alongside each other. Merck believes both have extremely viable market potential, with the PAH market forecasted to experience a 4% compound annual growth rate over six years, jumping from $6.1 billion in worldwide annual revenue in 2020 to $7.8 billion by 2026.

Other potential approvals in the pipeline include an expanded indication for Verquvo, which is already cleared for chronic heart failure. A phase 3 trial testing the therapy in patients with chronic heart failure and reduced ejection fraction is estimated to complete in early 2025. The initial Bayer-Merck collab, along with recently approved Adempas, are included in the list of expected drugs set to drive Merck’s lofty goal of $10 billion in peak revenue. To further contextualize the figure, the company reported $48.7 billion in total sales last year.  

Other treatments a bit further down the pipeline include MK-2060 for end-stage renal disease patients. The therapy is currently in a phase 2 dosing trial with a completion date in March 2023. Merck said it has the potential to be an effective anticoagulant with minimal bleeding risk. Lastly, Merck’s atherosclerosis drug MK-0616, a potential orally dosed treatment that lowers cholesterol, is in a phase 2b study with a completion date of February 2023.