Regeneron gains after Q2 beat; FDA action on high-dose Eylea expected in Q3
Dzmitry Dzemidovich
Regeneron Pharmaceuticals (NASDAQ:REGN) added ~5% pre-market Thursday after the company reported better than expected financials for Q2 2023 and cited a potential FDA decision on a high-dose version of its blockbuster eye disease therapy Eylea this quarter.
In June, the regulator rejected the 8 mg of aflibercept injection, citing production issues at the companyâs contract manufacturer, Catalent (CTLT).
Regeneron (REGN) said it intends to submit the additional regulatory data required by the FDA by mid-August and expects the regulator to decide on its marketing application during Q3 2023.
During the quarter, the company exceeded Street forecasts for major components in its financials as its revenue increased ~11% YoY to $3.2B thanks to a ~1% YoY rise in net product sales and a ~26% YoY improvement in collaboration revenue, which reached $1.8B and $1.3B, respectively.
Despite a ~4% YoY decline, its leading revenue generator, Eylea, topped forecasts, adding $2.4B to the topline globally even as U.S. Eylea sales fell ~8% YoY to $1.5B. Meanwhile, the atopic dermatitis therapy Dupixent, for which Regeneron (REGN) has partnered with Sanofi (SNY), brought $2.8B in net product sales, indicating ~33% YoY growth.
Skin cancer drug Libtayo, rheumatoid arthritis therapy Kevzara, and heart disease drug Praluent added $210M, $99.5M and $140.3M in net product sales, respectively, indicating ~49% YoY, ~21% YoY, and ~29% YoY growth, respectively.
Meanwhile, Regeneron (REGN) reported $968.4M in net income for the period with ~14% YoY growth and narrowed full-year GAAP projections for R&D and SG&A expenses to $4.3B â $4.5B and $2.5B â$2.7B, respectively.

More on Regeneron 

Regeneron: CRL For High Dose Eylea Gives Vabysmo A Wider Opening
Regeneron Pharmaceuticals: Overdependence On Eylea Brought To The Forefront
Regeneron: Eylea Hype Past, But '23 H2 Will Be A Gut Check
Regeneron cut to Neutral at Cannacord on FDA snub for high-dose Eylea
Regeneron falls as FDA rejects high-dose Eylea (update)
Seeking Alphaâs Quant Rating on Regeneron Pharmaceuticals