Page 1

Coherus Coherus BioSciences Reports First Quarter 2021 Financial Results and Immuno - oncology and Biosimilar Pipeline Progress May 6 , 2021 - Junshi Biosciences transaction is followed by rapid toripalimab progress including initiation of first BLA submission to the U.S. FDA , positive interim analysis in pivotal esophageal cancer trial , and selection for ASCO plenary session - -Toripalimab is one of four additional Coherus product candidates projected for approval in the United States over the next two years - - First quarter UDENYCAⓇ net sales of $ 83 million - - Conference call today at 4:30 p.m. ET- REDWOOD CITY , Calif . , May 06 , 2021 ( GLOBE NEWSWIRE ) -- Coherus BioSciences , Inc. ( " Coherus " or the " Company " , Nasdaq : CHRS ) , today reported financial results for the quarter ended March 31 , 2021. The Company also provided a progress update on its anti - PD - 1 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 ) . " Over the next two years , we project four additional Coherus product candidates will be approved in the United States , including three biosimilars and our anti - PD - 1 antibody , toripalimab , " said Denny Lanfear , CEO of Coherus . " We believe this diversified product portfolio has the potential to generate significant revenue growth and fuel our investments in novel immuno - oncology therapies with the potential to improve care and outcomes for cancer patients . " " With significant new clinical data and the first U.S. BLA submission underway , toripalimab is already exceeding our expectations , " Lanfear continued . " During a rigorous multi - year evaluation of the global checkpoint inhibitor landscape , we defined the preclinical and clinical properties required for our investment in a PD - 1 blocking antibody . Toripalimab's demonstrated potency , unique molecular properties and advanced pivotal clinical development program in numerous cancer types surpassed our stringent criteria . It is gratifying to see the accumulating external validation for toripalimab including selection for ASCO's plenary session , Breakthrough Therapy Designation from the FDA for nasopharyngeal carcinoma , and the additional recent approvals in China . We believe these developments and the external interest we have already received to evaluate potential toripalimab combinations positions this product candidate as a significant potential growth driver for Coherus for many years . " FIRST QUARTER 2021 FINANCIAL HIGHLIGHTS • GAAP net loss of $ 173 million for the first quarter of 2021 was primarily driven by the $ 145 million upfront payment to Junshi Biosciences for U.S. and Canada rights to the anti - PD - 1 antibody toripalimab and one - time charges associated with the termination of the CHS - 2020 biosimilar program as part of the strategic realignment of research and development resources toward immuno - oncology . • Non - GAAP net income for the first quarter of 2021 was $ 0.4 million , or $ 0.01 per share . • Cash flow from operations was $ 1.4 million . • Net product revenue , consisting of net sales of UDENYCAⓇ ( pegfilgrastim - cbqv ) was $ 83 million for the first quarter of 2021. With approximately 20 % share of the overall pegfilgrastim market , UDENYCA maintains its position as the leading pegfilgrastim biosimilar . • Coherus had cash , cash equivalents and marketable securities of $ 400 million at March 31 , 2021 . • In April 2021 , the Company received $ 50 million from Junshi Biosciences ' acquisition of 2,491,988 shares of Coherus stock at a price per share of $ 20.06 . PIPELINE HIGHLIGHTS Toripalimab , a PD - 1 blocking antibody product candidate , in collaboration with Junshi Biosciences : ⚫ Junshi Biosciences initiated the rolling submission of the biologics license application ( " BLA " ) with the U.S. Food and Drug Administration ( " FDA " ) for toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma ( " NPC " ) . The FDA has granted toripalimab Breakthrough Therapy Designation for this indication . The BLA submission is expected to be completed mid - year 2021 , with potential approval in the first half of 2022 . • Results of JUPITER - 02 , a randomized , double - blind , placebo - controlled , multi - center , Phase 3 clinical trial evaluating toripalimab for first - line NPC , will be featured in the plenary session and in the official press program of the 2021 ASCO Annual Meeting in early June . • In JUPITER - 06 , a randomized , double - blind , placebo - controlled , multi - center , Phase 3 clinical trial with 514 patients enrolled , toripalimab in combination with paclitaxel / cisplatin as first - line treatment for patients with advanced esophageal squamous cell carcinoma ( " ESCC " ) achieved the pre - specified primary endpoints of progression free survival ( " PFS " ) and overall survival ( " OS " ) at the interim analysis . Data from the study are expected later in 2021 . • Coherus and Junshi Biosciences plan to file additional toripalimab BLA supplements with the FDA over the next three years for multiple rare and highly prevalent tumor types , including non - small cell lung cancer ( " NSCLC " ) . An ongoing Phase 3 clinical study of toripalimab in combination with standard chemotherapy as the first - line treatment of patients with advanced NSCLC reached its primary endpoint of PFS at the interim analysis in December 2020. Top - line results are