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Coherus Coherus BioSciences Reports Second Quarter 2021 Financial Results and Immuno - oncology and Biosimilar Pipeline Progress Aug 5 , 2021 -1st line nasopharyngeal indication and 2nd / 3rd line indications to be concurrently submitted 3Q 2021 in the toripalimab BLA- - CHS - 201 ( LucentisⓇ biosimilar ) BLA submitted to FDA - -CHS - 1420 ( HumiraⓇ biosimilar ) BLA review progressing with December target action date - - Second quarter 2021 UDENYCAⓇ net sales of $ 88 million - - Conference call today at 5:00 p.m. ET- REDWOOD CITY , Calif . , Aug. 05 , 2021 ( GLOBE NEWSWIRE ) -- Coherus BioSciences , Inc. ( " Coherus " or the " Company " , Nasdaq : CHRS ) , today reported financial results for the quarter ended June 30 , 2021. The Company also provided a progress update on its PD - 1 blocking antibody , toripalimab , its lead immuno - oncology candidate for the potential treatment of various solid tumors , as well as other late - stage pipeline product candidates including CHS - 201 , a biosimilar LucentisⓇ ( ranibizumab ) , CHS - 1420 , a wholly owned biosimilar HumiraⓇ ( adalimumab ) , and CHS - 305 , a biosimilar AvastinⓇ ( bevacizumab ) . " With two biosimilar BLAs currently under FDA review and a toripalimab BLA submission expected to be completed soon , we are making strong progress toward our objective to diversify and grow our product portfolio , " said Denny Lanfear , Coherus CEO . " We project that within one year we will have four approved products , including UDENYCAⓇ , in the United States , and that in 2023 we will have five marketed products generating revenue to invest in our immuno - oncology business . " SECOND QUARTER 2021 FINANCIAL HIGHLIGHTS • Net product revenue , consisting of net sales of UDENYCAⓇ ( pegfilgrastim - cbqv ) was $ 88 million . • GAAP net loss of $ 29.9 million was primarily driven by increased R & D and regulatory expenses to support the advancement of toripalimab and the biosimilar pipeline product candidates . • Non - GAAP net loss was $ 27.3 million . • At June 30 , 2021 , Coherus had cash , cash equivalents and marketable securities of $ 454.4 million . • In April 2021 , the Company received $ 50 million from Junshi Biosciences ' acquisition of 2,491,988 shares of Coherus stock . PIPELINE HIGHLIGHTS Coherus is planning an analyst day event in the fourth quarter of 2021 Toripalimab , a PD - 1 blocking antibody product candidate , in collaboration with Junshi Biosciences : • Following a recent meeting with the United States Food and Drug Administration ( " FDA " ) , Coherus ' immuno - oncology partner , Junshi Biosciences , plans to submit the biologics license application ( " BLA ” ) for toripalimab in combination with chemotherapy for 1st line treatment of metastatic or recurrent nasopharyngeal carcinoma ( " NPC " ) concurrently with toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC . Junshi Biosciences expects to complete the BLA submission for these indications later this quarter . • Data from a Phase 3 clinical trial evaluating toripalimab for the treatment of non - small cell lung cancer will be presented in September at the World Conference on Lung Cancer . • Data from a Phase 3 clinical trial evaluating toripalimab for the treatment of esophageal squamous cell carcinoma will be presented in September at the annual meeting of the European Society for Medical Oncology . CHS - 201 , a biosimilar Lucentis® ( ranibizumab ) product candidate in collaboration with Bioeq AG : • Bioeq AG recently submitted the CHS - 201 BLA . Pending acceptance of the BLA by the FDA , Coherus anticipates a mid - 2022 target action date for the BLA review . CHS - 1420 , a wholly owned biosimilar Humira® ( adalimumab ) product candidate : • The review of the CHS - 1420 BLA is progressing with a target action date of December 2021. Coherus plans to launch CHS - 1420 on or after July 1 , 2023 , if approved . CHS - 305 , a biosimilar Avastin® ( bevacizumab ) product candidate in collaboration with Innovent Biologics ( Suzhou ) Co. Ltd : • Coherus is conducting the three - way pharmacokinetic study to facilitate the potential CHS - 305 BLA submission . SECOND QUARTER 2021 FINANCIAL RESULTS