Regeneron projects no near-term sales of its blockbuster COVID-19 antibody given FDA action to ground it

In its first bullet point in its release breaking down fourth quarter earnings, Regeneron said that sales of its coronavirus antibody treatment were $2.30 billion in the period, which represented a huge chunk of its total revenue figure for the company—$4.95 billion.

In the same bullet, Regeneron was quick to add that excluding sales of REGEN-COV, the company’s revenue still was up 17% in the period.

This is a particularly relevant point considering that Regeneron isn’t expecting any revenue from the antibodies in the foreseeable future. An FDA ruling 11 days ago banned the treatment for use in patients infected by the omicron variant.

“With the FDA’s recent amendment to REGEN-COV’s emergency use authorization, we do not expect to record any U.S. REGEN-COV sales in the first half of 2022,” Robert Landry, Regeneron’s chief financial officer, said.

It was a short, brilliant run for REGEN-COV, which generated $6.19 billion in sales in 2021, accounting for 38.5% of the company’s revenue haul of $16.07 billion. The COVID-19 antibody treatment in 2020 bringing in $8.50 billion.

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Perhaps helped by an endorsement from former President Donald Trump, the treatment was held in such high regard that some states continued to use it even after it was shown to be ineffective against the variant.

Regeneron CEO Len Schleifer said that the company’s technology platform makes it “uniquely positioned” to quickly develop and deliver potential medicines to combat the pandemic. To this end, Regeneron is working with regulatory authorities to define clinical pathways to bring additional antibody treatment options, he said.

“We are progressing next-generation antibodies that are active against omicron, delta and other variants of concern,” Schleifer said. “We’re scaling up manufacturing efforts and completing the necessary requirements to begin clinical trials for a next-generation candidate in the coming months.”

Regeneron has a large collection of antibodies from which to develop new COVID meds, chief scientific officer George Yancopoulos said.

“As a variant emerges, we select new candidate antibodies that will work against the new variant but will also retain their activity against the previous variants of concern,” Yancopoulos said.

Aside from REGEN-COV, the company’s bread-and-butter drugs, Eylea and Dupixent, performed well. Macular degeneration treatment Eyela continued its steady upward trajectory, generating $1.55 billion in sales in the quarter, topping consensus estimates and bringing 2021 U.S. sales of the drug to $5.79 billion, up from $4.95 billion in 2020.

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Eczema and asthma drug Dupixent had worldwide sales of $1.77 billion in the fourth quarter, a 51% increase from last year’s fourth quarter, with overall Dupixent sales for the year coming in at $6.20 billion, up 53% from 2020.

“Dupixent’s outlook is bright,” Schleifer said. “There are significant opportunities to increase market penetration rates in approved indications, and we’re in the midst of a wave of new data submissions and launches in potential new indications.”