As everyone waits for Covid-19 vaccine shots, cases have surged and a new variant of the coronavirus that’s more infectious has been discovered. That’s why it was encouraging when
said late Tuesday that its REGN-COV2 cocktail of antibodies against the virus seems to be helping hospitalized patients in a large clinical trial. If the final readout is good, the treatment could help manage the Covid upsurge and bring Regeneron a 2021 revenue boost.
In premarket trading Wednesday, Regeneron stock (ticker: REGN) edged up about 0.5% to $486, from Tuesday’s close of $484.
Infusions of synthetic antibodies from Regeneron and
(LLY) each got emergency authorizations from U.S. regulators for use in keeping infected patients out of the hospital. But those treatments haven’t yet proven their benefit in sicker patients already hospitalized. In October, Lilly stopped recruitment for a trial of its single antibody bamlanivimab in hospitalized Covid patients after a monitoring committee concluded the treatment wasn’t working. Regeneron’s Tuesday announcement that its data monitors decided to continue its own trial is positive news.
The antibody infusions help infected patients who haven’t yet generated antibodies of their own fight the virus. In the Tuesday release, Regeneron chief scientific officer George Yancopoulos said infected patients without a strong immune response in the trial died at nearly three-times the rate of those with natural antibody levels—if treated only with standard drugs like steroids or the
(GILD) antiviral remdesivir.
When patients without natural antibodies got Regeneron’s cocktail, their virus levels dropped dramatically and their rates of death or need for mechanical ventilation fell by 22% compared with those who received a placebo, according to preliminary data in the press release. Benefits were particularly strong in the first week after hospitalization. The data are preliminary, cautioned Yancopoulos, and trials of the Regeneron antibodies will continue in the U.S. and the U.K.
“This outcome represents a middle-of-the-road result with neither early discontinuation for overwhelming success (a best case result) nor early stoppage for futility (worst case result),” wrote RBC Capital Markets analyst Kennen MacKay, in a Wednesday note. While seeing Tuesday’s news as “incrementally positive” for Regeneron, MacKay rates the stock at Sector Perform.
The new data suggesting a benefit from the antibodies could stimulate use of the treatment, which for now is authorized for use in infected outpatients at high risk of hospitalization. Recent news reports have said that uptake of the treatments has been weak.
Advance sales of Regeneron’s REG-COV2 cocktail contributed $40 million to the company’s September quarter revenues of $2.2 billion. Following its November emergency use authorization by the U.S. Food and Drug Administration, Regeneron is producing 300,000 doses of its cocktail for outpatients under an agreement with the federal government.
An authorization for use in hospitalized patients, or additional orders for outpatient use, could add up to $1 billion in 2021 sales for the Regeneron cocktail, according to Wall Street estimates. Lilly’s government sales of its antibody product provided an unexpected boost of half a billion dollars to its guidance for 2020 sales. Lilly also got an emergency approval for one of its anti-inflammatory drugs as a treatment for Covid patients. On Dec. 15, Lilly said that its 2021 sales of all Covid treatments could range from $1 billion to $2 billion.
Write to Bill Alpert at [email protected]