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 fell after peaking at $1.63 billion in last year's third quarter. The drop 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.
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.