Summary
Regeneron Pharmaceuticals, Inc. (REGN) has filed a Current Report (8-K) on January 9, 2023, providing preliminary unaudited financial updates and corporate developments discussed at the J.P. Morgan Healthcare Conference. The company reported strong preliminary U.S. net product sales for EYLEA® (aflibercept) Injection, reaching approximately $6.26 billion for the full year 2022, with $1.50 billion in the fourth quarter. However, fourth-quarter EYLEA sales were impacted by a temporary shift to off-label use of compounded Avastin® and a temporary closure of a patient co-pay assistance fund. Encouragingly, recent data suggests the shift to off-label Avastin is beginning to reverse. Additionally, Regeneron anticipates a $30 million acquired in-process research and development (IPR&D) charge in Q4 2022 and full-year 2022 results, related to an upfront payment for a collaboration with CytomX Therapeutics, Inc. This charge is expected to reduce GAAP and non-GAAP diluted earnings per share by approximately $0.21 for the fourth quarter. Investors should note that these are preliminary, unaudited figures, subject to change upon finalization of financial statements.
Key Highlights
- 1Full-year 2022 preliminary U.S. net product sales for EYLEA® (aflibercept) Injection reached approximately $6.26 billion.
- 2Fourth-quarter 2022 preliminary U.S. net product sales for EYLEA® were approximately $1.50 billion.
- 3Q4 2022 EYLEA® sales were negatively impacted by a short-term shift to off-label use of compounded Avastin® and a temporary closure of a patient co-pay assistance fund.
- 4Recent market data indicates the shift to off-label Avastin® is already starting to reverse.
- 5The company expects a preliminary acquired in-process R&D charge of approximately $30 million for Q4 2022 and full-year 2022, related to a CytomX Therapeutics, Inc. collaboration.
- 6This IPR&D charge is estimated to reduce Q4 2022 GAAP and non-GAAP diluted EPS by approximately $0.21.
- 7All provided financial figures are preliminary and unaudited, subject to final financial statement closing procedures.