Why Is Regeneron Pharmaceuticals Moving Higher Today?

Regeneron Pharmaceuticals Inc 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 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 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.