Dive Brief:
- Merck & Co. executives forecast between $5 billion and $7 billion in sales of the company's COVID-19 pill through the end of 2022, assuming an expected emergency use authorization from the Food and Drug Administration in December.
- The sales of molnupiravir, as the experimental, antiviral pill is known, could go higher if additional research shows it can prevent disease in people who have become exposed but not sick, Merck executives said on an earnings call Thursday. Their estimate is based on agreements that the company made or is working toward with countries and other end-users.
- Merck is forecasting these big sales in spite of a pledge to keep molnupiravir affordable for low- and middle-income nations. On Wednesday, Merck signed a deal with a United Nations-backed public health group that will grant exclusive sublicenses to boost supply of the pill in some of those countries.
Dive Insight:
The coronavirus pandemic is turning into a huge business for big pharma. Pfizer and Moderna, for example, have reported roughly $11 billion and $6 billion from sales of their vaccines, respectively, in the first six months of 2021, while Regeneron reported about $3 billion in sales of its antibody drug REGEN-COV.
Merck's third quarter earnings call was its first opportunity to discuss expectations for molnupiravir since it returned positive Phase 3 trial results and submitted its request for emergency clearance to the FDA. So far, the pill has been shown to reduce the risk of hospitalization and death in patients with mild and moderate disease, and as such is expected to play a big role in treating people who get sick, especially as many people haven't been vaccinated and "breakthrough" cases can occur in people who have.
In particular, as a pill that can be taken at home, it is likely to be used more frequently than Gilead's antiviral Veklury and antibody treatments from Regeneron and Eli Lilly, which require patients to receive an infusion or injection at a hospital or clinic.
Merck expects to manufacture 10 million courses by the end of 2021 and believes it can double that output in 2022.
The company's sales forecast, meanwhile, is based on "agreements that have been signed, those in line of sight, and others that have high probability of execution," said Frank Clyburn, president of Merck's human health division.
In 2021, the company expects to record between $500 million and $1 billion in sales from the pill.
Next year, Merck expects results from a trial called MOVe-AHEAD, which looks at household contacts of COVID-19 patients, to determine whether molnupiravir prevents symptomatic cases. The trial is scheduled to complete in April, and should it return positive results, sales growth could be even bigger, executives said.
Merck will share profits equally with Ridgeback Therapeutics, from whom it licensed molnupiravir just two months after the biotech itself acquired the drug from Emory University in 2020.