Regeneron Pharmaceuticals

Regeneron Pharmaceuticals delivered impressive fourth-quarter results with revenues as well as earnings being well above analyst expectations. Even disregarding the effects of contributions from REGEN-COV and Ronapreve, fourth quarter 2022 sales climbed 14% compared to the prior year, highlighting the commercial strength and expanding the diversification of the business. The company made significant advancements in its pipeline, most notably filing a biologic licensing application for aflibercept 8 milligrams in wet AMD and diabetic macular edema. These initiatives position Regeneron for a potential U.S. launch in late August this year. During the quarter, they acquired FDA clearance for Libtayo in combination with chemotherapy as a first-line treatment for advanced non-small cell lung cancer, making Libtayo the second PD-1 or PD-L1 antibody licensed, regardless of a patient’s histology or PD-L1 expression level. The company also presented data from its rapidly developing oncology pipeline, including for the LAG-3 antibody fianlimab in combination with Libtayo in advanced non-small cell lung cancer, the CD20xCD3 bispecific odronextamab in B-cell lymphomas, and the BCMAxCD3 bispecific linvoseltamab in multiple myeloma. Dupixent was also approved for prurigo nodularis in Europe. In addition, the team intends to expedite the clinical development of their next-generation COVID-19 antibody in 2023. We give Regeneron Pharmaceuticals a ‘Hold’ rating with a revised target price.