At the beginning of 2020, Regeneron was in defense mode, scrambling to protect its top-selling Eylea against Novartis’ newly launched Beovu. Now, the company has quickly seized the opportunity presented by a safety flag for its new rival.
In the first quarter of 2020, Eylea sold $1.17 billion in the U.S., about 3% ahead of industry watchers’ expectations—even if it was a step back from the prior quarter’s haul of $1.22 billion.
Regeneron attributed the sequential decline to reduced demand amid the COVID-19 pandemic. Total script numbers and new patients starts were both lower in late March and early April, CEO Len Schleifer said during a conference call on Tuesday.
Commercial chief Marion McCourt said COVID-19 hit Eylea harder in its newer indications in diabetic eye disease than in wet age-related macular degeneration. McCourt described the decline in the last two weeks of March and first two weeks of April as “sharp,” with overall demand for the month 15% lower than the same time last year. Numbers have rebounded recently, she said, but warned that demand will be uncertain as the pandemic continues.
Eylea’s performance could have been worse, given Novartis’ new anti-VEGF entry Beovu, which beat out Eylea in some secondary measures in clinical trials. But physicians recently noticed—and Novartis later confirmed—that Beovu’s use can be associated with occlusive retinal vasculitis that could lead to vision loss. While Novartis stressed that the incidence is very rare—about 1 to 2 cases in 10,000 injections—it did find that only half of healthcare centers continued to order Beovu in the first quarter.
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Novartis’ admission is a reprieve for Eylea. Soon after that Beovu safety signal emerged, Regeneron and its ex-U.S. partner Bayer conducted a review of their own clinical and post-marketing data. Across eight phase 3 trials involving “tens of thousands of injections,” there were no similar reports, Regeneron Chief Scientific Officer George Yancopoulos said on Tuesday’s call.
As for post-marketing experience—comprising more than 32 million Eylea doses—“the rate of any possibly related safety event was less than 1 out of every 6 million Eylea doses sold,” and these cases were always linked to presumed infectious endophthalmitis, he added.
Overall, Regeneron reported total revenue of $1.83 billion in the first quarter, beating analysts’ consensus.