On July 1, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it has completed the acquisition of Sanofi’s stake in Libtayo (cemiplimab), providing Regeneron with exclusive worldwide development, commercialization, and manufacturing rights to the medicine originally discovered in Regeneron’s laboratories (Press release, Regeneron, JUL 1, 2022, View Source [SID1234616436]). The intent to purchase Libtayo was announced on June 2, 2022.
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In 2015, Regeneron and Sanofi entered into the Immuno-oncology License and Collaboration Agreement whereby the companies split Libtayo’s worldwide operating profits equally and co-commercialized Libtayo in the U.S., with Sanofi solely responsible for commercialization outside the U.S. With today’s closing, Regeneron will now record 100% of global net sales and expenses for Libtayo.
Regeneron intends to update its full year 2022 financial guidance to reflect the Libtayo purchase during its second quarter 2022 earnings announcement in early August.
Anticipated Impact to Second Quarter 2022 Financial Results from Recently Completed Business Development Transactions
There is no financial or accounting impact to second quarter 2022 financial results as a result of the Libtayo transaction.
On May 31, 2022, Regeneron announced that it had successfully acquired Checkmate Pharmaceuticals, Inc. for a total equity value of approximately $250 million. As a result of the Checkmate acquisition, Regeneron expects to record in the second quarter of 2022 an acquired in-process research and development (IPR&D) charge of approximately $195 million, which would negatively impact GAAP and non-GAAP diluted earnings per share by approximately $1.70. This acquired IPR&D charge and its resultant impact on diluted earnings per share represent unaudited estimates that have not been subject to Regeneron’s quarterly financial statement closing procedures, and therefore actual amounts could differ from what the Company currently anticipates.