Business
Coherus BioSciences Reports Fourth Quarter and Full Year 2022 Results
– Net product sales of $45.4 million in the fourth quarter 2022 and $211.0 million in FY 2022 –– FDA is planning the toripalimab manufacturing site inspection
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"– Net product sales of $45.4 million in the fourth quarter 2022 and $211.0 million in FY 2022 –– FDA is planning the toripalimab manufacturing site inspection in Q2 2023 –– UDENYCA® autoinjector approved by FDA; UDENYCA® on-body injector under review by FDA –– Planning underway for potential 2023 commercial launches of toripalimab, YUSIMRY™, UDENYCA® AI and UDENYCA® OBI –– Conference call today at 5 p.m. ET – REDWOOD CITY, Calif., March 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today reported financial results for its fiscal fourth quarter and full year ended December 31, 2022 and recent business highlights: RECENT BUSINESS HIGHLIGHTS The U.S. Food and Drug Administration (FDA) has notified the Company of the planned dates in the second quarter of 2023 for its required inspection of the toripalimab manufacturing facility in China. The inspection, previously hindered by COVID-related travel restrictions, is part of the FDA’s review of the biologics license application (BLA) for toripalimab, a PD-1 inhibitor for the treatment of nasopharyngeal carcinoma (NPC). Coherus plans to launch toripalimab in the U.S. directly upon potential approval by the FDA.The FDA on March 3, 2023 approved a single-dose, prefilled autoinjector presentation of UDENYCA® (pegfilgrastim-cbqv), which represents the first presentation innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative treatments that expand access and address the needs of patients undergoing cancer treatment. Coherus plans to launch UDENYCA® AI in the second quarter.The FDA review of the prior approval supplement for Coherus’ third pegfilgrastim presentation, the UDENYCA® on-body injector (OBI), is ongoing, and Coherus plans to launch UDENYCA® OBI directly upon potential approval later this year.In February, the U.S. Centers for Medicare & Medicaid Services (CMS) assigned to CIMERLI® (ranibizumab-eqrn) a permanent, product-specific Q-code, which will become active on April 1, 2023. The Q-code is expected to enable more efficient billing processes and speed time to reimbursement for providers.On March 3, 2023, Coherus implemented a reduction in force impacting approximately 60 full-time and part-time employees in order to focus resources on strategic priorities including the c...