After consecutive setbacks at the FDA, Regeneron's string of recent troubles with its Eylea franchise is continuing to pull down the drugmaker.
Over the first three months of 2025, Regeneron's sales from the Eylea franchise—approved in a range of retinal conditions like macular degeneration and diabetic retinopathy—fell 26% versus 2024’s first quarter, the company said in a Tuesday press release. Overall, the franchise generated $1.04 billion during the quarter.
Digging into the numbers, standard Eylea’s U.S. sales dropped 39% in the first quarter to $736 million, missing Wall Street’s consensus sales estimate by nearly $100 million, analysts at Evercore ISI wrote in a note to clients Tuesday.
Meanwhile, Regeneron’s newer and higher-dose version of the eye med, Eylea HD, grew U.S. sales 54% over the same period in 2024 to $307 million. Still, those gains weren’t enough to offset a significant sales decline for the franchise overall between January and March.
On a conference call Tuesday, CEO Leonard Schleifer, M.D., Ph.D., was quick to admit that Regeneron’s performance in the first quarter was “mixed.”
The New York drugmaker endured “some difficult news related to our retinal franchise,” which was otherwise “offset by encouraging news relating to the rest of our commercial portfolio,” Schleifer explained.
Commenting on the Eylea franchise’s struggles in the quarter, the CEO noted that the overall size of the branded anti-VEGF category “contracted” during the first three months of the year. Schleifer attributed the shift to more patients using off-label bevacizumab—aka Avastin—to treat their retinal conditions, which is likely being driven by affordability issues linked to funding gaps at copay assistance foundations, he argued.
Avastin, while mainly used to treat cancer, works similarly to Eylea by blocking the vascular endothelial growth factor (VEGF) protein, which plays a key role in the formation of blood vessels.
Executives at Roche—which offers its own VEGF inhibitor, Vabysmo, that competes directly with Eylea in many indications—also commented on a branded VEGF market contraction in 2025’s first quarter during an earnings call last week, the Evercore analysts pointed out in their note.
Roche's Vabysmo sales reached 1.02 billion Swiss francs ($1.2 billion) during the first quarter, an 18% increase worldwide.
The other shoe drops
While Regeneron remains confident that Eylea HD sales will continue to grow over time, copay problems and off-label Avastin use aren’t all there is to the saga of the VEGF franchise’s recent stumbles.
Alongside the financial details on its first-quarter performance, Regeneron also revealed that the FDA last week rejected the company’s application for a prefilled syringe version of Eylea HD. Just days before that complete response letter, the FDA also rebuffed Regeneron’s bid to win extended dosing intervals for Eylea HD across all the med’s approved indications.
Transitioning U.S. Eylea HD patients to a prefilled syringe—versus the current vial and needle format—forms a “critical component” in the product’s evolution and is “necessary to be competitive with Roche’s Vabysmo,” the Evercore analysts said in Tuesday’s note.
Schleifer, for his part, expressed disappointment with the FDA's decision and sought to provide clarity on the situation following “several teleconferences” with the agency in the aftermath of last week’s rejection.
The FDA’s issue appears to come down to a “third-party component supplier,” Schleifer said, referring to a contractor responsible for, at least in part, producing the prefilled syringe device itself.
“Based on our conversations with the FDA, we believe that there’s one key issue that is left to resolve,” Schleifer said, without identifying the contractor by name. “There are a few other minor ones, which I think were just clarification, but the one key issue relates to a supplier, and the supplier has told us that the FDA asked for some data.”
The supplier already had the data needed and turned the information over to the FDA posthaste following the rejection, Schleifer said.
Eylea HD is already approved in the EU as a prefilled syringe using the same device, design and components that are included in Regeneron’s U.S. application, the Evercore team noted.
Although Regeneron expects the Eylea HD prefilled syringe will eventually win approval in the U.S., Schleifer admitted that there remains “a little bit of uncertainty on how fast this could all get resolved.”
The Evercore team noted that the prefilled syringe rejection represents the latest in a “laundry list of CRLs” that Regeneron’s Eylea HD has received since an initial FDA rebuff over third-party manufacturing issues in June 2023.
Still, Schleifer was quick to defend his company, noting that he feels Regeneron’s regulatory and manufacturing teams are “first rate.”
“The kinds of issues that have come up are reflecting, in my view, an increased scrutiny by the FDA—post-COVID—on contract manufacturers,” Schleifer said.
“I think the FDA is trying to step up the game, if you will, of these contract manufacturers,” the CEO added. “And since we’re so active, we see more.”
The long view
Despite Eylea HD’s recent setbacks, Regeneron is far from throwing in the towel, with additional reviews currently underway at the FDA to attempt to push the medicine into macular edema following retinal vein occlusion and to secure a potential shift to monthly dosing.
“While we expect competitive pressures for Eylea to persist, our focus remains on promoting the ongoing adoption of Eylea HD, which has the potential to become the new standard of care,” Regeneron’s executive vice president of commercial, Marion McCourt, said on the company’s conference call.
“With these label enhancements and anticipated approval of the prefilled syringe, we expect to see an acceleration in Eylea HD demand,” McCourt said.
Regeneron posted its Eylea updates as the company reported total first-quarter sales of $3 billion, a 4% decrease compared to the same period last year.
As for the rest of Regeneron’s commercial medicine chest, cancer med Libtayo grew total sales—both in the U.S. and beyond—by 8% to $285 million for the quarter. Regeneron’s next highest-earning drug, cholesterol med Praluent, suffered a 19% sales decline to $57 million in the U.S.
The company also shares sales on the immunology megablockbuster Dupixent with French drugmaker Sanofi. Last week, Sanofi reported first-quarter Dupixent sales of 3.5 billion euros (roughly $4 billion). Sanofi is anticipating that annual sales of Dupixent could reach a whopping $22 billion by the end of the decade.
After Regeneron reported its first-quarter results, the company's share price dropped by about 6% on Tuesday afternoon.