Business
Coherus BioSciences Reports Third Quarter 2021 Results
– Key milestones achieved driving near-term commercial product portfolio expansion – – Three BLAs now under FDA review: PD-1 inhibitor toripalimab, biosimilar
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"– Key milestones achieved driving near-term commercial product portfolio expansion – – Three BLAs now under FDA review: PD-1 inhibitor toripalimab, biosimilar Lucentis®, biosimilar Humira® – – Multiple additional applications to FDA expected in 2022 – – UDENYCA® delivers 3rd quarter 2021 net sales of $83 million – – Conference call today at 5:00 p.m. ET – REDWOOD CITY, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today reported financial results for the quarter ended September 30, 2021 and highlighted recent achievement of key milestones toward potential near-term expansion of the commercial product portfolio: ACHIEVEMENT OF KEY MILESTONES DRIVING NEAR-TERM COMMERCIAL PRODUCT PORTFOLIO EXPANSION Successful UDENCYA® on-body injector clinical trial is expected to enable 2022 submission of a prior approval supplement to the UDENYCA® BLA.FDA accepted the BLA for CHS-201, a biosimilar Lucentis® (ranibizumab), and assigned a target action date of August 2022.FDA review of the BLA for CHS-1420, a biosimilar Humira® (adalimumab), is advancing toward the target action date in December 2021.FDA accepted the toripalimab BLA for advanced nasopharyngeal carcinoma and granted priority review with a target action date of April 2022.Positive esophageal squamous cell carcinoma Phase 3 clinical data is expected to enable submission of a toripalimab BLA supplement in 2022.Positive progression free survival data (PFS) from the CHOICE-01 Phase 3 clinical trial evaluating toripalimab in non-small cell lung cancer were presented in September. A final analysis of PFS and an additional interim overall survival analysis are expected by early first quarter 2022, after which Coherus and partner Junshi Biosciences plan to discuss a potential submission of a BLA supplement with FDA. THIRD QUARTER 2021 FINANCIAL HIGHLIGHTS Net product revenue, consisting of net sales of UDENYCA® (pegfilgrastim-cbqv), was $82.5 million.GAAP net loss of $38.5 million was driven by lower net product revenue and increased R&D and regulatory expenses to support the development and regulatory submissions of toripalimab and biosimilar pipeline product candidates.Non-GAAP net loss was $26.6 million, adjusting for $11.9 million in stock-based compensation expense.At September 30, 2021, cash, cash equivalents and market...