Delays in the decision dates for high-dose Eylea are linked to issues at a Catalent-owned facility. Once these are resolved, Regeneron expects “to receive favorable action” on these applications, CEO Leonard Schleifer told investors.
Regeneron delivered a second-quarter performance that handily beat analyst expectations, but regulatory snags tempered enthusiasm over the company’s results.
On Friday, Regeneron announced that three of its Eylea HD applications—a pre-filled syringe, an every-four-week dose and another for use in macular edema following retinal vein occlusion—have been delayed due to issues at a third-party manufacturing site owned by Catalent, the CDMO giant that in February 2024 was acquired by Novo Nordisk. The FDA was scheduled to release its verdicts for these filings in August.
Aside from those manufacturing problems, Regeneron seemed confident in the approvability of these three Eylea HD applications. “Based on our discussions, we believe that there’s nothing significant left to be done,” CEO Leonard Schleifer said during the company’s investor call on Friday morning. “We are expecting, once the resolution of the filling issues has occurred, to receive favorable action, we hope, from the FDA.”
Novo is currently working with the FDA to resolve these issues, Schleifer told investors. Regeneron has not yet specified a revised timeline for these decision dates.
Problems at the Catalent site also tripped up Regeneron’s odronextamab, a bispecific monoclonal antibody which it was proposing as a third-line treatment for relapsed or refractory follicular lymphoma. The FDA declined to approve the drug on July 30, with the pharma on Friday saying the application was “also impacted by the Catalent” issue. It is unclear if these third-party manufacturing problems were the only reason behind the rejection.
Things were sunnier on the earnings side. Regeneron’s Q2 revenues came out to $3.68 billion, beating consensus estimates by 11% and representing a 4% year-on-year growth. Earnings per share at $12.89 were 53% ahead of analyst forecasts.
Regeneron’s stock had bolted up 40 points in early morning trading Friday but has since returned to market open price.
“Consensus feared a 2Q miss, but results were well above expectations,” Leerink analysts wrote to investors on Friday. In particular, while U.S. sales of Eylea’s standard 2-mg formulation dipped 39% year-on-year to $754 million, it still came 6% ahead of forecasts. Meanwhile, the high-dose formulation of Eylea delivered a 20% consensus beat with its $393 million Q2 revenues, which represented a 29% increase from the same period last year.
Taken together, Regeneron’s total Eylea franchise—comprising both standard and high-dose formulations—took a 25% sales dip to $1.15 billion, but nevertheless outpaced forecasts by 9%, according to Leerink,
Dupixent, its Sanofi-partnered blockbuster anti-inflammatory antibody, surged 22% to bring in $4.34 billion in the quarter, delivering an 8% consensus beat. Regeneron saw strong growth across the rest of its portfolio, too, with the skin cancer drug Libtayo jumping 27% year-on-year to hit $376 million, while Praluent, used to lower cholesterol, saw a 16% sales increase to $222 million. Kevzara, indicated for inflammatory diseases, surged 39% to hit $152.2 million in worldwide revenue.
