Regeneron Pharmaceuticals Slumps As Sales Of High-Dose Eylea Disappoint

Regeneron Pharmaceuticals (NASDAQ: REGN) has seen a significant dip in its stock price following the release of lower-than-expected sales figures for its high-dose Eylea (aflibercept) Injection 8 mg. The drug, used to treat wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), failed to meet analysts' estimates in the fourth quarter of 2024, contributing to a 4% decline in the company's stock price in premarket trading.



Eylea HD, the higher dose of Regeneron's widely used eye treatment, generated US net product sales of $305 million in the fourth quarter, a stark contrast to the $457 million that had been estimated. Chris Schott of JPMorgan, maintaining an overweight rating on Regeneron, commented on the sales figures, stating, "Eylea HD sales in 4Q were well below consensus." He further noted that "it appears Eylea HD sales have effectively plateaued," indicating a possible stagnation in the product's revenue stream.

The lower sales figures for the higher dose version could reflect challenges in market penetration or competition from other treatments. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

For Regeneron, seven weeks can’t come soon enough. That’s when its longer-acting version of macular degeneration drug Eylea is up for a potential FDA approval. Until then, however, Regeneron and partner Bayer are taking a hit as customers are turning to Roche’s Vabysmo, which has a longer-acting formula, allowing age-related macular degeneration (AMD) and diabetic macular edema (DME) patients to take three annual shots to the eyeball instead of six.

In the first quarter of this year, Eylea’s U.S. sales fell to $1.43 billion, a 5% drop from the previous quarter, Regeneron said on Thursday. It was the second straight quarter that Eylea’s sales have fallen after peaking at $1.63 billion in last year's third quarter. The drop in sales coincides with the launch of Vabysmo, which was approved in January of last year.

As it did in its previous quarterly report, Regeneron tried to minimize the impact of Roche’s drug. In a conference call, commercial chief Marion McCourt referred to “increasing competitive pressure” but only after citing “wholesaler inventory levels” and “higher sales-related deductions” as reasons for Eylea’s slide.

“This is an overall competitive dynamic in the anti-VEGF category—not something we would necessarily identify with a particular product—more the totality of competition,” McCourt said.

Last week, Roche reported sales of Vabysmo at $486 million, a 40% increase from the fourth quarter of 2022. The company now projects the product's annual sales will reach $2 billion. Vabysmo has captured 12% of the AMD and 5% of the DME market, Roche’s pharma chief Teresa Graham said during a conference call, with 70% to 80% of the switches coming from Eylea.

When asked on Thursday about switching versus new patient starts, Regeneron deflected the question. The company is quick, however, to talk about its 8 mg version of Eylea, which has a June 27 decision date at the FDA and is backed by stellar data indicating it may have superior staying power to Vabysmo.

“Eylea is the well-established, gold-standard anti-VEGF treatment and aflibercept 8 mg has the potential to be as paradigm-changing as Eylea when it was introduced more than a decade ago,” McCourt said.

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Josh Schimmer of Evercore ISI is one of the few analysts questioning Eylea’s new formulation, saying it has no better drying than its 2 mg dose and might not be approved.

“During the phase 3 windows where we can attempt apples/apples comparisons with 2 mg Eylea, the slope of fluid recurrence looks the same—which means there isn’t good evidence that the effect really lasts longer,” Schimmer wrote in a note to clients. “Wetter retinas might lead to worse vision outcomes.”

For the quarter, Regeneron’s total revenue came in at $3.16 billion. While it was a 7% increase from the first quarter of 2022, it also was a decline from the $3.41 billion sales figure the company posted in the fourth quarter of last year.

Unlike Eylea, the upward trajectory of Dupixent remains intact. Its sales reached $2.49 billion in the first quarter, topping the consensus expectation of $2.38 billion. Dupixent delivered a 37% increase from the first quarter of last year, with Regeneron’s revenue for the Sanofi-partnered treatment coming in at $798 million.

While Regeneron Pharmaceuticals reported better-than-expected third-quarter results, sales of the company’s lead drug Eylea declined amid increased competition. Pictured: Regeneron logo on a light brown building/Shutterstock, Lev Radin

For Regeneron, seven weeks can’t come soon enough. That’s when its longer-acting version of macular degeneration drug Eylea is up for a potential FDA approval. Until then, however, Regeneron and partner Bayer are taking a hit as customers are turning to Roche’s Vabysmo, which has a longer-acting formula, allowing age-related macular degeneration (AMD) and diabetic macular edema (DME) patients to take three annual shots to the eyeball instead of six.