JPM23: Regeneron reports disappointing sales of powerhouse Eylea, says it's a 'blip'

Drugmakers often save good news to release at the buzzy J.P. Morgan Healthcare Conference. But on Monday morning, heading into Regeneron’s presentation, the company released bad news.

Sales of Eylea in the fourth quarter were $1.5 billion—considerably short of analyst expectations between $1.63 billion and $1.65 billion. After nearly a dozen years on the market, has the macular degeneration juggernaut finally plateaued?

That possibility has been a concern for months with biosimilar competition looming in 2024 and Roche emerging with a formidable challenger in its longer-acting treatment Vabysmo. That drug allows many patients to go four months between shots as opposed to two months for Eylea.

With news of the disappointing sales, Regeneron’s stock price had declined by 7% by Monday afternoon.

During Regeneron’s JPM presentation, CEO Len Schleifer, M.D., Ph.D., credited the disappointing performance to a “short-term shift” to off-label Avastin. The Roche product—which has been on the market for nearly two decades to treat a wide range of cancers—is not approved for macular degeneration.

Without providing details, Schleifer said the Avastin off-label shift was "associated with the temporary closing … of a fund that provides patients with copay assistance."

“But our recent data has suggested that now this copay assistance is back and available and the shift is reversing," he added.

In support of Eylea's outlook, Schleifer pointed to the drug's 75% “branded category share,” its preliminary 2022 sales estimate of $6.3 billion and the recent trial success of its 8-mg formulation, which gives it the potential to become the “next-generation standard of care.”

Regeneron expects approval for its 8-mg formulation—the company’s answer to Vabysmo as it allows some patients to be dosed every four months—to come this year.

As for the concern over recent sales of Eylea, Schleifer called it a “short-term blip which should not affect the trajectory of the molecule at all.”

To confirm the “blip,” investors will be anxious to see whether Eylea rebounds in the first quarter of this year.