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Gilead Sciences Inc.
GILD,
has steadily expanded the use of Veklury while much of the nation’s attention has shifted to the arrival of new antivirals that can be picked up at a pharmacy counter.
So far this year, the Food and Drug Administration granted approval to Veklury as an outpatient treatment for COVID-19 patients who are at high risk of hospitalization or death; the regulator upgraded the authorization to full approval for use in young children; and the World Health Organization revised its conditional recommendation for Veklury, saying it now recommends treatment for patients with mild or moderate COVID-19 who are at high risk of hospitalization.
Gilead first received emergency authorization for remdesivir, as it was then called, as a treatment for hospitalized COVID-19 patients on May 1, 2020, making it the first new drug to demonstrate it helped hospitalized COVID-19 patients during one of the darkest points in the pandemic.
The authorization sent Gilead’s stock soaring, hitting a three-year high of $80.00 on April 30, the day before the anticipated authorization. Shares have since pulled back, with Gilead’s stock closing at $61.77 on Tuesday.
The antiviral is now widely considered part of the standard of care for COVID-19 patients, including being listed as a preferred therapy by the National Institutes of Health. It’s also been a moneymaker for Gilead, bringing in $2.8 billion in sales in 2020 and $5.5 billion in 2021, and it was one of the company’s top-selling drugs last year, second only to HIV drug Biktarvy.
A report published earlier this year found that U.S. hospitals represented by the group-purchasing organization Vizient Inc. had more in total spending on Veklury than any other drug in 2021, including mega-blockbusters like AbbVie Inc.’s
ABBV,
rheumatoid arthritis drug Humira and Merck & Co. Inc.’s
MRK,
cancer therapy Keytruda.
But the authorizations at the end of last year of Pfizer Inc.’s
PFE,
Paxlovid and Merck’s Lagevrio shifted interest toward COVID-19 medications that don’t require a trip to an infusion center.
“There will always be a role for both oral and IV therapies,” Merdad Parsey, Gilead’s chief medical officer, told investors in February, according to a FactSet transcript of the call. “As availability of oral therapies becomes broader, they’re used relatively early in the course of disease. Many people may progress and/or not get treated early enough and end up in the hospital. And, at that point, I think that’s…where the role of IV therapies is going to come in.”
That said, Gilead has an oral formulation of Veklury in clinical trials, with Phase 1 data expected sometime this summer.
The company is expected to bring in $1.1 billion in sales of Veklury in the first quarter of this year, for a total of $2.1 billion in sales for the year, according to a FactSet consensus. Gilead has set guidance of $2 billion in sales of Veklury this year, with the assumption that omicron is the year’s only major surge.
“It may be possible GILD could have a higher tail than expected,” RBC Capital Markets analyst Brian Abrahams told investors in February, citing the ongoing clinical studies of the oral version of Veklury.
The company is set to report its first-quarter earnings on Thursday.
Gilead’s stock has declined 14.9% so far this year, while the broader S&P 500
SPX,
is down 12.4%.
