Regeneron's quarterly sales of Eylea drop below $1B for the first time in 8 years

As regulatory delays continue to plague Regeneron’s efforts to develop Eylea, sales for the eye disease medicine remain in decline.

In the first quarter of this year, the Eylea franchise generated $941 million in the United States, a 10% year-over-year decline and a 13% sequential drop. It was the first time since the second quarter of 2018 that the franchise failed to achieve U.S. quarterly sales of at least $1 billion.

While sales of Eylea’s high-dose formulation were up 52% year over year to $468 million, they were also down 7% sequentially from an all-time high of $506 million in the fourth quarter of last year. Meanwhile, sales of Eylea’s original formulation declined 36% year over year to $473 million.  

With Regeneron's Q1 report, its shares dropped by 6%.

The entrance of a formidable challenger in Roche’s Vabysmo, which was launched in 2022 and achieved worldwide sales of 1.02 billion Swiss francs ($1.3 billion) in the first quarter, has contributed to Eylea’s decline. But also playing a role have been regulatory setbacks—most of them manufacturing-related—which have hindered the progression of Eylea HD.

On Wednesday, Regeneron said that an FDA decision date on its application for a second contract manufacturer for its pre-filled syringe (PFS) version of Eylea HD came and went on April 26. The company offered no explanation for the delay.

Regeneron is seeking to bring another third-party manufacturer online after receiving a complete response letter (CRL) from the FDA in October because of unresolved issues at the Indiana plant of its primary manufacturing partner, Novo Nordisk. 

Regeneron has resubmitted its PFS application for approval of the troubled facility, which was formerly owned by Catalent. The plant has been reinspected by the FDA, Regeneron CEO Len Schleifer said on a conference call. 

“Regeneron and both third-party filling manufacturers are working closely with the FDA to resolve all outstanding issues and we anticipate a regulatory decision on one or both of the applications during this quarter,” Schleifer added. 

In its competition with Roche, Regeneron has been a step behind throughout. The Swiss company gained FDA approval of its PFS version of Vabysmo in July of 2024.

Still, there is hope that the company can regain some of its lost market share, as commercial chief Marion McCourt pointed out some of Eylea HD’s advantages on the call.

“Eylea HD now has the broadest label and greatest dosing flexibility of any anti-VEGF medicine, following recent label enhancements to include retinal vein occlusion (RVO) and additional dosing options that range from every four weeks through every 20 weeks,” McCourt said.

McCourt added that if Regeneron can gain its PFS approval that it would “bring the best-in-class device to retina specialists and help drive continued uptake for Eylea HD.” 

Compensating for the lack of success for Regeneron’s Eylea franchise is the continued upward trajectory of Dupixent. The Sanofi-partnered treatment generated worldwide sales of $4.9 billion in the first quarter, an increase of 33%. 

Of the haul, Regeneron realized $1.6 billion in collaboration revenue from Dupixent, helping boost the company to a hefty 19% year-over-year quarterly revenue increase to $3.6 billion.