
In showdown with Roche, Regeneron gears up for potential Eylea expansion amid Covid decline
Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.
The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.
One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.
Vabysmo, on top of blocking the same VEGF receptor as Eylea, also inhibits a growth regulator called angiopoietin-2. Plus, Vabysmo can be dosed once every 16 weeks, compared to Eylea’s once every eight weeks once past the loading dose schedule.
CEO Len Schleifer told an analyst who asked about Eylea plans to “give us a second, we’ll disconnect all the Roche people on the call so we can get you our strategy,” amid a chuckle in the background.
“There’s a lot of thought that’s going to go in — between now and what we hope will be our late August approval — on pricing, on rollout, on targeting, on strategy, etc, etc.,” Schleifer said. “But we’re working on that. We have to get our label, we have to get it approved and we’ll have everything else ready to go. The initial launch will be with a vial, and then we hope down the road not too far with a prefilled syringe.”
Eylea recorded just under $1.5 billion in sales in the last quarter, down approximately $51 million quarter over quarter.
Dupixent, the Sanofi-partnered IL-4 and IL-13 targeting therapy, brought in just short of $2.5 billion last quarter.
CSO George Yancopoulos said Friday on the earnings call that a readout of the Phase III BOREAS trial in COPD is expected in the first half of 2023. The primary endpoint of that trial is the annualized rate of acute, moderate and severe COPD exacerbations.
Q4 earnings overall showed a 31% drop in revenue compared to Q4 in 2021, pulling in $3.4 billion. When expanded to the year, 2022 revenue was $12.2 billion, a 24% drop compared to 2021.
However, Regeneron noted the drop was the result of declining sales of Covid products REGEN-COV and Ronapreve, the monoclonal antibody cocktail that went by different names in the US and in Europe. The EUA for REGEN-COV was pulled early last year when the therapy was found to be ineffective against the Omicron variant.
This follows a trend mentioned on Regeneron’s previous earnings call, where execs pointed to a 15% drop in revenue that quarter compared to the year before — citing lost revenue from Covid-related mAbs.
Despite the drop, Regeneron was quick to point out that outside Covid, revenue was up for both the quarter and the year: 14% and 17% respectively.
Analysts with Cowen wrote after the conference call Friday that they “were comforted to hear mgmt’s comments with respect to competitive market dynamics for Eylea ahead of the HD Eylea launch. The Dupi performance was very strong (yet again), and COPD data could come around April. The Y/Y expense increase was largely anticipated. We reiterate our Outperform as the fundamentals for REGN remain strong.”
Shares of $REGN went up 4% after the market opened, up $30 a share and continuing an upward trend of over 25% in the last year.