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Coherus Coherus BioSciences Reports Third Quarter 2021 Results Nov 8 , 2021 - 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 marketable securities were $ 468.7 million . " With three BLAs currently under FDA review , and positive clinical data expected to enable submission of multiple additional applications for marketing authorization in 2022 , we are making rapid progress toward our goals to diversify and grow our commercial product portfolio , " said Denny Lanfear , Coherus CEO . “ UDENYCAⓇ continues to provide strong funding for Coherus as we invest in our pipeline and prepare for a succession of anticipated new product launches in 2022 and 2023. " THIRD QUARTER 2021 FINANCIAL RESULTS Net product revenue , consisting of net sales of UDENYCAⓇ , was $ 82.5 million and $ 113.6 million during the three months ended September 30 , 2021 and 2020 , respectively , and $ 253.2 million and $ 365.4 million during the nine months ended September 30 , 2021 and 2020 , respectively . The decreases were primarily due to a decrease in the number of units of UDENYCAⓇ sold during the three and nine months ended September 30 , 2021 , as well as an increase in discounts and allowances during the nine months ended September 30 , 2021 . Cost of goods sold ( COGS ) was $ 21.3 million and $ 9.0 million during the three months ended September 30 , 2021 and 2020 , respectively , and $ 45.5 million and $ 26.0 million during the nine months ended September 30 , 2021 and 2020 , respectively . Until the first quarter of 2021 , Coherus sold inventory that was manufactured and expensed prior to the approval of UDENYCAⓇ in late 2018. This inventory was depleted in the first quarter of 2021 , and COGS now fully reflects per unit acquisition cost . Additionally , COGS for the third quarter of 2021 included a $ 5.2 million write - off of inventory that did not meet Coherus ' acceptance criteria . UDENYCA® COGS also includes a mid single digit royalty on net sales payable through the first half of 2024 . Research and development ( R & D ) expense for the three months ended September 30 , 2021 was $ 54.1 million compared to $ 38.9 million for the same period in 2020 , an increase of $ 15.2 million which was mainly the result of higher development and regulatory costs in support of the advancement of pipeline product candidates . For the nine months ended September 30 , 2021 , R & D expense was $ 312.3 million compared to $ 98.1 million for the same period in 2020 , an increase of $ 214.2 million which included the $ 136.0 million upfront license fee paid to Junshi Biosciences in 2021 . Selling , general and administrative ( SG & A ) expense for the three months ended September 30 , 2021 was $ 39.9 million compared to $ 32.0 million for the three months ended September 30 , 2020 , an increase of $ 7.9 million which was primarily driven by increased commercialization expenses to