Eylea crosses quarterly U.S. blockbuster line for Regeneron as Dupixent nears new FDA expansion

Regeneron’s Eylea has for the first time generated over $1 billion in quarterly U.S. sales, though the company’s overall performance looks flat in at least one analyst’s view.

During the third quarter, the blockbuster eye therapy reeled in $1.02 billion for Regeneron in the U.S., compared with $992 million in the second quarter, while partner Bayer’s reported $655 million for ex-U.S. sales came slightly below expectations.

Eylea might also see more upside soon—at least before biosimilars hit. In August, Eylea nabbed an FDA nod in wet age-related macular degeneration as a 12-week dosing formulation, and the agency is scheduled to decide on the drug’s use in diabetic retinopathy by May 13, 2019, after a previous setback. The agency recently turned back Regeneron's application for a prefilled syringe in that indication.

But despite the new and forthcoming approvals, Eylea's future won't be challenge-free. Novartis’ phase 3 brolucizumab and Roche’s phase 2 faricimab are both hoping to land on the scene soon. Then again, when those potential Eylea challengers reviewed their data earlier this year, analysts were unimpressed in their prospects for threatening Eylea.

“It doesn’t appear that any potential near-term entrance can provide substantially different dosing flexibility, duration or visual gains” from what Eylea has achieved, said Regeneron President and Chief Scientific Officer George Yancopoulos, M.D., Ph.D., on the second-quarter earnings call.

Nevertheless, in a video briefing with investors, Bernstein analyst Ronny Gal said he “would not call it a great quarter” at Regeneron because there’s no particular strong revenue beat across its portfolio. For example, total Sanofi collaboration revenue—which includes those from PCSK9 inhibitor Praluent, rising eczema star Dupixent and new rheumatoid arthritis treatment Kevzara—was $256 million, about 6% lower than what analysts had projected.

That doesn’t mean the drugs, especially Dupixent, aren't doing well. Sanofi recorded a Dupixent haul of €225 million for the quarter, a 28% sequential jump. The pair is now channeling some Dupixent efforts toward asthma, thanks to a recent nod for which analysts have pegged blockbuster peak sales.

Roughly 25% to 30% of the total 775,000 to 900,000 adult and adolescent patients in the U.S. with moderate-to-severe asthma have grown dependent on standard steroids, and that's the group for whom a biologic such as Dupixent could help, according to Regeneron commercial chief Marion McCourt. Talks with allergists and pulmonologists are well underway, and responses have been positive, she said.

Besides an asthma nod, Regeneron also announced on Tuesday that its application to expand Dupixent’s atopic dermatitis indication to adolescent patients 12 to 17 years of age has just won priority review at the FDA, with a decision set for March 2019. Meanwhile, clinical trials that aim to extend the drug’s reach to children as young as 6 months are also progressing.

Thanks to U.S. tax reform, Regeneron recorded third-quarter income tax expense of $41 million on a tax rate of 6.5%, compared with $177 million and 31.3% same time last year. The company is now guiding a lower full-year tax rate to 11% to 13%. Based on that, the company is upsizing in New York state, adding 1,500 jobs and new spaces for manufacturing, storage and lab testing.

Nov 6, 2018

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