Business
Coherus BioSciences Reports First Quarter 2023 Financial Results and Business Highlights
– UDENYCA® autoinjector approved and ready for May 2023 launch –– CIMERLI® product-specific Q-code now facilitating electronic reimbursement following April 1
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"– UDENYCA® autoinjector approved and ready for May 2023 launch –– CIMERLI® product-specific Q-code now facilitating electronic reimbursement following April 1 activation –– FDA inspection of toripalimab manufacturing site scheduled for May 2023 –– Toripalimab launch anticipated in Q3 2023, if approved –– YUSIMRY™ ready for planned July 2023 launch –– FDA review of UDENYCA® OBI BLA supplement progressing; launch anticipated in 2023, if approved –– Net product revenue of $32.4 million in the first quarter 2023 –– Conference call today at 5:00 p.m. Eastern Time – REDWOOD CITY, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, “the Company”, Nasdaq: CHRS), today reported financial results for the quarter ended March 31, 2023 and recent business highlights: RECENT BUSINESS HIGHLIGHTS CIMERLI® On April 1st, the permanent, product-specific Q-code assigned to CIMERLI® (ranibizumab-eqrn) by the U.S. Centers for Medicare & Medicaid Services (CMS) became active, enabling more efficient, electronic billing processes and reducing time to reimbursement for providers. Demand increased sharply as expected in April, with over 7,000 units of CIMERLI® shipped, exceeding in one month 70% of Q1 unit sales. UDENYCA® The FDA approved a single-dose, prefilled autoinjector (AI) presentation of UDENYCA® (pegfilgrastim-cbqv) on March 3, 2023, 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 later this month.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. Toripalimab The U.S. Food and Drug Administration (FDA) has notified the Company that it plans to conduct the required inspection of the toripalimab manufacturing facility in China later in May 2023. The inspections, previously hindered by COVID-related travel restrictions, are 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 anticipates potential FDA a...