When a phase 3 study revealed 30% efficacy for Merck and Ridgeback’s COVID-19 oral antiviral—a significant drop from the 50% figure the company touted at the trial’s interim stage—concerns emerged about the relevance of the treatment, especially considering a rival version was in the works from Pfizer.
But after barely passing muster from an FDA advisory committee, surviving by a 13-10 vote, and gaining emergency approval on Dec. 23, molnupiravir has found plenty of demand.
In the fourth quarter of last year, Merck registered sales of $952 million for molnupiravir. For 2022, the company projects sales of between $5 billion and $6 billion for the drug, “weighted to the first half of the year,” Merck CFO Caroline Litchfield said during a conference call Thursday.
The estimate includes only deals that have been announced so far and account for 10 million courses of the drug. Merck expects to have produced 30 million courses of the drug by the end of 2022.
Part of the early success of molnupiravir can be attributed to how quickly the company has been able to provide it. Within the next few days, Merck will have shipped more than 4 million courses to more than 25 countries, the company said. Approximately 3 million of those will be supplied to the U.S. as part of its procurement agreement.
In lab studies, Merck has shown the drug is active against the omicron variant. With deaths in the U.S. averaging 2,000 per day, the drug is playing an important role in the battle against the virus, said Dean Li, the chief of Merck Research Laboratories, who pointed to the phase 3 trial which was completed last year.
“Importantly, for physicians and patients, approximately 90% fewer deaths were seen in those taking molnupiravir,” Li said. “These results reinforce that molnupiravir can provide an important oral treatment option for certain adults at high risk for severe illnesses.”
The emergence of new variants has rendered some treatments ineffective, so Merck believes that with molnupiravir—and/or combination drugs that include it—it can keep the therapy relevant.
“The mechanism and the molecule is designed to be as variant-proof as can be theoretically possible,” Li said. “I do think it’s important that we have an arsenal of multiple mechanisms of action because in every viral disease that I know, the virus is pretty good at evading those multiple mechanisms.”
Molnupiravir helped Merck to an outstanding performance in the fourth quarter, with total revenue coming in at $13.52 billion. The figure topped Zacks consensus estimate of $12.6 billion and represented a 23% increase over the same quarter last year, with molnupiravir sales accounting for nine of those percentage points.
Also contributing heavily were superstar oncology medicine Keytruda and HPV vaccine Gardasil. Keytruda generated $4.577 billion in sales in the quarter, up 16%, while Gardasil sales reached $1.528 billion, up 50% from last year’s fourth quarter.
Merck’s revenue reached $48.7 billion last year, up 17% from 2020. The company projects sales of between $56.1 and $57.6 billion this year.