Regeneron plans summer launch for longer-lasting version of Eylea as it tries to fend off rival Roche

When he was asked to provide details on how Regeneron plans to launch its higher-dose version of Eylea later this year, CEO Len Schleifer took a playful jab at the analyst delivering the question.

“Give us a second, we’ll disconnect all the Roche people on the call, so we can get you our strategy,” Schleifer said during the company’s fourth-quarter conference call.

Joking aside, Regeneron and its Eylea partner Bayer are in a serious competition with Roche in the macular degeneration arena. Just over a year ago, Roche won FDA approval for Vabysmo, a longer-acting rival to Eylea, with the potential to cut doctor visits in half—a significant advantage considering administration of the drug is by way of a needle in the eye.

But last year, Regeneron presented data that indicate its new souped-up version of Eylea has more staying power than that of Vabysmo. In a phase 3 trial, 77% of patients with wet age-related macular degeneration (AMD) and 89% of those with diabetic macular edema (DME), were able to sustain a once-every-four-months regimen as opposed to the current formulation of Eylea, which requires a shot every two months.

If all goes according to plan and the FDA blesses it, Regeneron will launch the 8 mg dose of Eylea later this year, executives said Friday.

“Obviously, there’s a lot of thought that’s going to go in between now and what we hope is our late-August approval on pricing, on rollout, on targeting, on strategy,” Schleifer said. “Initial launch will be with a vial and then we hope down the road, not too far, with a prefilled syringe.”

Eylea sales came in at $6.3 billion in 2022, an 8% increase compared with 2021. This came despite a 3% drop for Eylea sales in the fourth quarter which Regeneron attributed to the temporary closing of a not-for-profit fund that provides co-pay assistance to patients and led some patients to switch to off-label Avastin.

“We believe we have substantially recovered from the issue,” Regeneron’s commercial chief Marion McCourt said, adding that the fund was restored later in the fourth quarter.

Still, some of the erosion has to be attributed to Vabysmo. Through the first three quarters of 2022, Roche reported sales of $282 million for its drug, with 70% of users having switched off of Eylea, the company told Evaluate Vantage.

“We’re conscious of competition in the marketplace,” McCourt said. “But to give a bit of an update, we continue to hear that (Vabysmo) use has been modest and has resulted with some patients switching back to other agents including Eylea most frequently.”

Overall, Regeneron reported revenue of $3.41 billion in the fourth quarter, a 46% drop from the previous year. The decline was attributed to the FDA sidelining COVID-19 antibody cocktail REGEN-COV, which was shown to lose effectiveness against the omicron variant.

Revenue for the year came in at $12.2 billion, a 24% decline from 2021. The company pointed out that excluding sales of REGEN-COV, revenue for the year was up 17%.

Despite the drops, the final figures surprised analysts who expected revenue for the fourth quarter to come in at $3.13 billion.

During a year in which it garnered three more label expansions, Dupixent sales increased 40% to $8.7 billion. Regeneron partners with Sanofi on the treatment for eczema, asthma and a host of other conditions.