Regeneron Pharmaceuticals Inc (NASDAQ:REGN) earned second-quarter adjusted EPS of $10.24, up 5% Y/Y, beating the $9.92 Street estimate.
Revenues increased 11% Y/Y to $3.16 billion, beating the consensus of $3.01 billion.
Dupixent global net sales (recorded by Sanofi) increased 33% to $2.79 billion versus the second quarter of 2022.
Eylea U.S. net sales decreased by 7% to $1.5 billion, and global sales were down 4% to $2.38 billion, primarily due to a lower net selling price driven by changing market dynamics, including increased competition.
In June, the FDA issued a Complete Response Letter for Regeneron’s aflibercept 8 mg Biologics License application due to an ongoing review of inspection findings at a third-party filler.
The FDA informed the company and Catalent Inc (NYSE:CTLT) that certain manufacturing data and other information are required from Catalent to allow the FDA to approve aflibercept 8 mg.
Regeneron said it expects to submit some manufacturing data required by the FDA by mid-August.
The FDA has stated that it intends to prioritize the review of this submission. Therefore the company anticipates the FDA will take action on the aflibercept 8 mg BLA during Q3 of 2023.
The U.S. Supreme Court issued a unanimous opinion, ending a nearly decade-long patent dispute related to Praluent (alirocumab). The decision affirms the United States Court of Appeals for the Federal Circuit’s opinion, which held that Amgen Inc’s (NASDAQ: AMGN) asserted U.S. PCSK9 patent claims were invalid.
Price Action: REGN shares are up 5.17% at $769.95 on the last check Thursday.
