With U.S. sales of $304 million during the second quarter, Regeneron’s high-dose version of Eylea came up just short of analyst projections. But it was a significant increase from the $200 million the new eye medication generated in the first quarter of the year.
The launch has helped the Eylea franchise to a rebound after U.S. sales had declined in each of the previous three quarters as it was under assault from Roche’s Vabysmo.
Additionally, Regeneron reported that its FDA decision date on its application for approval of multiple myeloma therapy linvoseltamab is likely to be delayed because of a manufacturing issue. The target date is August 22.
As for Eylea, sales for the franchise overall were at $1.53 billion in the second quarter, a 2% increase year over year and a 9% increase sequentially. It was the highest quarterly figure for the franchise since U.S. Eylea sales maxed out at $1.63 billion in the third quarter of 2022.
It was the third full quarter on the market for Eylea HD, which has roughly twice the staying power (four months) of its original formulation (two months). By comparison, Vabysmo, which debuted in early 2022 as a longer-acting answer to Eylea, achieved worldwide sales of 309 million Swiss francs ($324 million) in its third full quarter on the market.
Pointedly, Regeneron CEO Len Schleifer said that Eylea HD “continues to out-perform recent launches in the anti-VEGF category.”
“We are encouraged that despite increased competition in the anti-VEGF space, we have achieved a strong Eylea HD launch trajectory while maintaining our category-leading combined Eylea HD and Eylea market share of 45%,” Schleifer said on a conference call.
Last week, Roche reported that worldwide sales of Vabysmo reached 947 million Swiss francs ($1.1 billion) in the period, exceeding the blockbuster mark for the first time in a quarter. Bayer, which commercializes Eylea outside of the US, will report its quarterly earnings next week.
Eylea’s performance helped Regeneron to a revenue beat, topping analyst projections by nearly $200 million. Revenue for the quarter came in at $3.55 billion, a 12% increase year over year and 13% sequentially.
Doing the heavy lifting was Dupixent, which generated worldwide sales of $3.56 billion. Revenues for the medicine are recorded by Sanofi under the companies' antibody partnership.
But Regeneron’s collaboration revenue from the partnership was $1.1 billion in the second quarter, which was up 21% year over year.
The company anticipates another bump from Dupixent with an expected approval from the FDA in September to treat chronic obstructive pulmonary disorder (COPD).
Sales also increased 42% for Libtayo to $297 million as the cancer drug, which was approved in 2018, is on track to become a blockbuster this year.
“The only miss—and a slight one at that—was from Eylea HD (US sales of $304M vs. $320M), but that should be looked at in the context of Eylea franchise YoY growth of 2%, which was ultimately a pleasant surprise to us given Vabysmo’s strong launch,” analyst Cory Kasimov, of Evercore ISI, wrote in a note to clients.
As for the manufacturing issue with linvoseltamab, Schleifer said that it has been resolved but that a re-inspection is unlikely to happen before the FDA decision date.
“There’s been a lot of third-party, filler-type manufacturing issues with lots of (complete response letters) across the biopharmaceutical space,” Schleifer said on the quarterly conference call. “We had one last year with HD Eylea and this was a case where the FDA was inspecting our filler for a different product and they found some observations.”