Regeneron 2nd-qtr financials beat expectations

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) today announced financial results for the second quarter of 2023 and provided a business update that pleased investors and sent the firm’s up 4.2% to $769.81 in early market activity.

The company noted that total revenues for the quarter rose 11% to $3,158 million, 6% higher than consensus estimates. On a generally accepted accenting principle (GAAP) basis, net income came in at $1,182 million, a rise of 5%, with net income per share, diluted at $10.25, also up 5% and topping analysts' average estimates of $9.84, according to Refinitiv data.

Regeneron recalled that, in June this year, the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8mg, a high dose version of ophthalmic drug Eylea, for the treatment of patients with neovascular age-related macular degeneration (wet AMD), DME, and diabetic retinopathy (DR). The CRL was issued solely due to unresolved observations resulting from an FDA inspection at a third-party contract manufacturing organization, Catalent. Regeneron expects a US decision on the higher-dose version in the third quarter, much earlier than market expectations.