1. - Interim results to be presented September 17 at the European Society for Medical Oncology (ESMO) Congress 2021 -

    - Data support the use of toripalimab with chemotherapy as first-line therapy for patients with ESCC –

    - Coherus and Junshi Biosciences plan to submit a BLA supplement for 1L ESCC in 2022 –

    SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) and Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) today announced positive interim results from the pivotal study "JUPITER-06" (NCT03829969), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as…

    - Interim results to be presented September 17 at the European Society for Medical Oncology (ESMO) Congress 2021 -

    - Data support the use of toripalimab with chemotherapy as first-line therapy for patients with ESCC –

    - Coherus and Junshi Biosciences plan to submit a BLA supplement for 1L ESCC in 2022 –

    SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) and Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) today announced positive interim results from the pivotal study "JUPITER-06" (NCT03829969), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone.

    The results will be summarized by Dr. Feng Wang, Professor at Sun Yat-sen University Cancer Center (SYUCC), Guangzhou, in a mini-oral session during the ESMO Congress 2021 on Friday, September 17, 2021 at 12:05 pm Eastern Time. The abstract (#1373MO) is now available on the ESMO website.

    "The findings of this interim analysis provide strong evidence that the addition of toripalimab to chemotherapy as a first-line treatment for advanced or metastatic ESCC patients has superior PFS and OS than chemotherapy alone," said Dr. Wang. "We look forward to updated analyses of overall survival of the JUPITER-06 study in the future and believe that these results will build a strong argument to support the use of toripalimab in combination with chemotherapy as a new standard first-line treatment in patients with advanced or metastatic ESCC."

    "A strong and consistent efficacy and safety profile is emerging for toripalimab across multiple tumor types as data read out from pivotal clinical trials in melanoma, nasopharyngeal carcinoma, urothelial cancer, lung cancer and now also esophageal squamous cell carcinoma," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We believe toripalimab could be a potential new treatment choice where patients truly need better options. We will collaborate with Coherus to advance a BLA supplement for ESCC to make toripalimab available as quickly as possible for these patients in the U.S."

    "With JUPITER-06, toripalimab has once again exhibited compelling efficacy in a first-line setting," said Denny Lanfear, CEO of Coherus. "The significant PFS and similarly robust overall survival data demonstrate that toripalimab in combination with chemotherapy could provide significant clinical benefits to patients with advanced or metastatic esophageal squamous cell carcinoma. We plan to work closely with our partner, Junshi Biosciences, to pursue a BLA supplement for this new indication expeditiously."

    About JUPITER-06

    A total of 514 treatment-naive advanced or metastatic patients were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin chemotherapy followed by toripalimab or placebo maintenance. The primary endpoints were PFS as assessed by a blinded independent central review (BICR) and overall survival (OS).

    • At a prespecified interim analysis on March 22, 2021, with median follow-up of 7.4 and 7.3 months in the two arms, there was a significant improvement in OS for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.43-0.78], P=0.00037) with median OS of 17.0 vs. 11.0 months;



    • One-year OS rates were 66.0% vs.43.7% for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm, respectively;



    • A significant improvement in PFS assessed by BICR was also detected for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.46-0.74], P<0.00001);



    • The OS and PFS benefits were observed across key subgroups, including all PD-L1 expression subgroups;



    • The incidence of Grade ≥3 adverse events (AEs) (73.2% vs 70.0%) and fatal AEs (8.2% vs 8.2%) were similar between the two arms. No new safety signals were observed.

    Junshi Biosciences and Coherus are planning in 2022 to submit a biologics license application supplement to the United States Food and Drug Adminstration for toripalimab for first-line treatment, in combination with platinum-based chemotherapy, of advanced or metastatic ESCC. In China, the supplemental New Drug Application of this indication has been accepted by the National Medical Products Administration (NMPA) in July, 2021.

    About Toripalimab

    Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system's ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials are evaluating the efficacy and safety of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

    In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designations for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 44 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA, and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first fully human neutralizing monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 12 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

    Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for Coherus and Junshi to file a BLA in the United States for toripalimab for ESCC in 2022; the potential for Coherus and Junshi to file additional BLAs in the United States for toripalimab over the next three years for multiple rare cancers and highly prevalent cancers; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, lung cancer, esophageal squamous cell carcinoma, or any indication; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

    Coherus Contact Information:

    IR Contact:

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com 

    +1 (650) 395-0152

    Media Contact:

    Sheryl Seapy

    Real Chemistry

    sseapy@realchemistry.com

    +1 (949) 903-4750

    Junshi Biosciences Contact Information

    IR Team:

    Junshi Biosciences

    info@junshipharma.com

    + 86 021-2250 0300

    Solebury Trout

    Bob Ai

    bai@soleburytrout.com

    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li

    zhi_li@junshipharma.com

    + 86 021-6105 8800



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  2. REDWOOD CITY, Calif., and SHANGHAI, China, Sept. 15, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) and Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) today announced publication of a cover article in the September issue of Nature Medicine featuring clinical data from the pivotal study "JUPITER-02", a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC).

    Titled Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial, the paper highlights that the…

    REDWOOD CITY, Calif., and SHANGHAI, China, Sept. 15, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) and Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) today announced publication of a cover article in the September issue of Nature Medicine featuring clinical data from the pivotal study "JUPITER-02", a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC).

    Titled Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial, the paper highlights that the addition of toripalimab to standard of care gemcitabine-cisplatin (GP) chemotherapy as a first-line treatment for patients with recurrent or metastatic NPC provided superior progression free survival (PFS) compared to GP alone [median PFS of 11.7 vs 8.0 months, hazard ratio (HR) = 0.52 (95% confidence interval (CI): 0.36–0.74), P = 0.0003], and with a manageable safety profile. The impact of the addition of toripalimab on PFS was demonstrated in patients regardless of PD-L1 expression status. Although overall survival data were not yet mature, as of February 18, 2021, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.603 (95% CI: 0.364–0.997)). The incidence of grade ≥3 treatment emergent adverse events (TEAEs) (89.0% vs 89.5%), TEAEs leading to discontinuation of toripalimab/placebo (7.5% vs 4.9%), and fatal TEAEs (2.7% vs 2.8%) was similar between both arms. Immune-related adverse events (irAEs) (39.7% vs. 18.9%) and Grade ≥3 irAEs (7.5% vs. 0.7%) were more frequent in the toripalimab arm. The full results can be found in the on-line edition of Nature Medicine.

    "There are currently no PD-1 blocking antibodies approved for NPC in the United States. We are pleased that this study has been selected for cover article publication in this highly-respected journal," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "This is a strong signal that further validates the potential advance that toripalimab in combination with chemotherapy would represent as a new standard-of-care first-line therapy for patients with advanced NPC, an aggressive and difficult-to-treat cancer."

    A biologics license application has been submitted to the U.S. Food and Drug Administration ("FDA") for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

    About JUPITER-02

    The JUPITER-02 Study (ClinicalTrials.gov identifier: NCT03581786) is a randomized, double-blind, placebo-controlled, international multi-center Phase 3 clinical trial comparing the efficacy and safety of toripalimab versus placebo in combination with Gemcitabine/Cisplatin, as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma. Professor Ruihua Xu from Sun Yat-sen University Cancer Centre is the lead principal investigator of the study. The largest Phase 3 clinical trial to date evaluating a checkpoint inhibitor plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, JUPITER-02 was conducted in mainland China, Taiwan and Singapore and enrolled a total of 289 patients.

    About Toripalimab

    Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system's ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials are evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April 2021, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

    In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and for toripalimab monotherapy in the 2nd line and subsequent treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 44 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first fully human neutralizing monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 12 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

    Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma or any indication; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for other clinical indications; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021, its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

    Coherus Contact Information:

    IR Contact:

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152

    Media Contact:

    Sheryl Seapy

    Real Chemistry

    sseapy@realchemistry.com

    +1 (949) 903-4750

    Junshi Biosciences Contact Information

    IR Team:

    Junshi Biosciences

    info@junshipharma.com

    + 86 021-2250 0300

    Solebury Trout

    Bob Ai

    bai@soleburytrout.com

    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li

    zhi_li@junshipharma.com

    + 86 021-6105 8800 



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  3. REDWOOD CITY, Calif. and SHANGHAI, China , Sept. 13, 2021 (GLOBE NEWSWIRE) -- Coherus Biosciences, Inc. (NASDAQ:CHRS) and Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) announced the presentation today of positive interim results from the pivotal study "CHOICE-01" (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC) without driver mutations. The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) per RECIST v1.1 compared to chemotherapy…

    REDWOOD CITY, Calif. and SHANGHAI, China , Sept. 13, 2021 (GLOBE NEWSWIRE) -- Coherus Biosciences, Inc. (NASDAQ:CHRS) and Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) announced the presentation today of positive interim results from the pivotal study "CHOICE-01" (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC) without driver mutations. The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) per RECIST v1.1 compared to chemotherapy alone. 

    The interim results were summarized on September 13 in a presentation by Professor Jie Wang, MD, PhD, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, during the Mini Oral Session at the 2021 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The abstract detailing the interim results was first made available on the WCLC website on August 18.

    "The addition of toripalimab to standard 1st-line chemotherapy in patients with advanced non-small cell lung cancer showed superior progression free survival, overall response rate and duration of response over chemotherapy alone, with a safety profile consistent with the PD-1 inhibitor class of drugs," said Dr. Wang. "Overall survival data are still maturing, with a notable emerging trend favoring the toripalimab-chemotherapy combination. We look forward to additional data from this study and believe CHOICE-01 results will provide strong evidence to support the use of toripalimab with chemotherapy as a 1st-line therapeutic option for NSCLC."

    A final analysis of progression free survival and an additional interim overall survival analysis are expected later this year. Junshi Biosciences and Coherus plan to meet with the United States Food and Drug Administration to discuss a potential submission to the pending biologics license application of an efficacy supplement for toripalimab for the first line treatment, in combination with platinum-based chemotherapy, of advanced, unresectable NSCLC without driver mutations.

    "CHOICE-01 is the first of four pivotal clinical trials evaluating toripalimab for the treatment of lung cancer to have clinical data presented, and its positive results are a promising start for toripalimab in lung cancer. Lung cancer is the most common form of cancer worldwide and the leading cause of death due to cancer, so there is a clear need to develop complementary approaches to standard chemotherapy to improve patient outcomes, maintain quality of life, and seek to improve survival for patients diagnosed with this deadly disease. We will work closely with Coherus and the regulatory authorities to bring this new therapy to patients in the United States," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences.

    "The CHOICE-01 interim data presented at WCLC are encouraging early evidence for toripalimab's clinical benefit in the first-line setting in non-small cell lung cancer," said Denny Lanfear, CEO of Coherus. "We eagerly anticipate additional results from this study and the potential to advance toripalimab toward registration for this indication in the United States."

    Toripalimab Phase 3 clinical trials in lung cancer

    Junshi Biosciences and Coherus are currently evaluating toripalimab in four pivotal Phase 3 clinical trials in lung cancer.

    • CHOICE-01, with 465 patients enrolled, is comparing toripalimab in combination with chemotherapy to chemotherapy alone as first-line treatment of advanced NSCLC. The study met the primary endpoint of progression free survival (PFS) at the interim analysis (data cut-off date: November 17, 2020). Patients receiving the placebo-chemotherapy combination were allowed to actively cross over to toripalimab treatment at the time of disease progression. Overall survival (OS) data are still maturing and exhibiting a trend favoring the toripalimab-chemotherapy arm as of a March 2021 observation. Final PFS and additional interim OS analyses are expected later in 2021.
    • Toripalimab is also being evaluated in combination with standard platinum-based chemotherapy in patients with NSCLC harboring EGFR mutations whose tumors are no longer responding to EGFR TKI therapy. Enrollment of 350 subjects in this Phase 3 study is on track to be completed by the end of 2021. The primary endpoint of the study is PFS. Initial results are expected in 2022.
    • In the neoadjuvant setting, toripalimab is being evaluated in combination with chemotherapy in a Phase 3 study with 406 patients with NSCLC scheduled to undergo surgical resection of their lung cancer. Enrollment is on track to be completed by the end of 2021. The primary endpoints of the study are major pathological response and event free survival. Initial results are expected in 2022.
    • Toripalimab is being evaluated in combination with standard chemotherapy in a Phase 3 study with 442 patients with extensive stage small cell lung cancer. Enrollment is complete. PFS and OS are the co-primary endpoints. Results are expected by the first half of 2022.

    About Toripalimab

    Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system's ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials are evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April 2021, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

    In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and for toripalimab monotherapy in the 2nd line and subsequent treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 44 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 12 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

    Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, lung cancer, or any indication; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for lung cancer or other clinical indications; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

    Coherus Contact Information:

    IR Contact:

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152

    Media Contact:

    Sheryl Seapy

    Real Chemistry

    sseapy@realchemistry.com

    +1 (949) 903-4750

    Junshi Biosciences Contact Information

    IR Team:

    Junshi Biosciences

    info@junshipharma.com

    + 86 021-2250 0300

    Solebury Trout

    Bob Ai

    bai@soleburytrout.com

    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li

    zhi_li@junshipharma.com

    + 86 021-6105 8800



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  4. REDWOOD CITY, Calif., Sept. 10, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that senior management will present at the 23rd Annual H.C. Wainwright Global Investment Conference. The presentation will be made available at 7 a.m. ET on Tuesday, September 14, 2021, during the virtual conference.

    The audio portion of the presentation will be available on the investors' page of the Coherus Biosciences website at http://investors.coherus.com.

    About Coherus BioSciences
    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus…

    REDWOOD CITY, Calif., Sept. 10, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that senior management will present at the 23rd Annual H.C. Wainwright Global Investment Conference. The presentation will be made available at 7 a.m. ET on Tuesday, September 14, 2021, during the virtual conference.

    The audio portion of the presentation will be available on the investors' page of the Coherus Biosciences website at http://investors.coherus.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

    Coherus Contact Information:

    IR Contact:

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152

    Media Contact:

    Sheryl Seapy

    Real Chemistry

    sseapy@realchemistry.com

    +1 (949) 903-4750



    Primary Logo

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  5. REDWOOD CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced upcoming medical conference presentations. Toripalimab clinical data will be presented September 13 at the IASLC 2021 World Conference on Lung Cancer and September 17 at the European Society for Medical Oncology Congress 2021. A real-world study comparing same-day and next-day administration of pegfilgrastim will be the topic of a poster presentation at the ASCO Quality Care Symposium on September 25. In addition, an oral presentation at the 54th Annual Scientific Meeting of the Retina Society on October 1 will highlight clinical data from the CHS-201 (also known as FYB201) program.

    IASLC 2021 World Conference on Lung…

    REDWOOD CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced upcoming medical conference presentations. Toripalimab clinical data will be presented September 13 at the IASLC 2021 World Conference on Lung Cancer and September 17 at the European Society for Medical Oncology Congress 2021. A real-world study comparing same-day and next-day administration of pegfilgrastim will be the topic of a poster presentation at the ASCO Quality Care Symposium on September 25. In addition, an oral presentation at the 54th Annual Scientific Meeting of the Retina Society on October 1 will highlight clinical data from the CHS-201 (also known as FYB201) program.

    IASLC 2021 World Conference on Lung Cancer (WCLC)

    • Mini-oral presentation: "CHOICE-01: A Phase 3 Study of Toripalimab versus Placebo in Combination with First-Line Chemotherapy for Advanced NSCLC" (Session #MA13)
    • Professor Jie Wang, MD, PhD, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, will present the interim results of the CHOICE-01 study detailed in the abstract published by WCLC on August 18, 2021.
    • Presentation time: September 13 at 8:10 p.m. Eastern Time

    European Society for Medical Oncology (ESMO) Congress 2021

    • Mini-oral presentation: "JUPITER-06: A Randomized, Double-blind, Phase 3 Study of Toripalimab versus Placebo in Combination with First-Line Chemotherapy for Treatment Naive Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)" (Abstract #1373MO)
    • Dr. Ruihua Xu, President and Professor, Sun Yat-sen University Cancer Center (SYSUCC), Guangzhou, will present interim results of the JUPITER-06 trial. ESMO will release the JUPITER-06 abstract at 6:05 p.m. Eastern Time on September 16.
    • Presentation time: September 17 at 12:05 p.m. Eastern Time

    ASCO Quality Care Symposium

    • Poster presentation: "Real-world comparison of febrile neutropenia rates with same-day versus next-day administration of pegfilgrastim" (Abstract #299)
    • Kyle Kitchen, PharmD, Director of Pharmacy Services, Utah Cancer Specialists
    • Poster Session B: September 25 at 7 a.m. Eastern Time

    The 54th Annual Scientific Meeting of the Retina Society

    • Oral presentation: "Columbus-AMD: Efficacy and Safety of FYB201, a Proposed Biosimilar to Ranibizumab, in Neovascular AMD (nAMD)"
    • Dr. Peter Kaiser, Professor of Ophthalmology, Cole Eye Institute of the Cleveland Clinic
    • Presentation Time: October 1 at 3:32 p.m. Eastern Time

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

    Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, upcoming presentations of toripalimab, CHS-201 or UDENYCA® clinical data; Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, lung cancer, or any indication; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for other clinical indications; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

    Coherus BioSciences Contact Information:

    IR Contact:

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com 

    +1 (650) 395-0152

    Media Contact:

    Sheryl Seapy

    Real Chemistry

    sseapy@realchemistry.com 

    +1 (949) 903-4750



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  6. SHANGHAI, China and REDWOOD CITY, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (("Coherus", NASDAQ:CHRS) announced today the completion of the rolling submission of the Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma ("NPC") and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

    The FDA recently granted Breakthrough Therapy Designation ("BTD") for toripalimab…

    SHANGHAI, China and REDWOOD CITY, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (("Coherus", NASDAQ:CHRS) announced today the completion of the rolling submission of the Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma ("NPC") and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

    The FDA recently granted Breakthrough Therapy Designation ("BTD") for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for 1st line treatment of recurrent, locally advanced or primary metastatic non-keratinizing nasopharyngeal carcinoma ("NPC") and earlier in 2020 granted BTD for toripalimab monotherapy for patients with recurrent or metastatic non-keratinizing NPC with disease progression on or after platinum-containing chemotherapy. BTD is intended to expedite the development and regulatory review of drugs where preliminary clinical evidence demonstrates substantial improvement over existing therapies for a severe or life-threating disease. Drugs with BTD will be granted more frequent FDA interaction and intensive guidance – including that from senior FDA officials – on the development program and ability to participate in various forms of expedited FDA review programs to provide patients with new therapy as soon as possible.

    "Toripalimab was approved for marketing early this year in China as the world's first immune checkpoint inhibitor to treat advanced NPC, an aggressive tumor with limited treatment options," said Patricia Keegan, MD Chief Medical Officer of Junshi Biosciences. "Toripalimab showed remarkable efficacy in the treatment of advanced NPC according to the results from POLARIS-02 and JUPITER-02 studies, as recognized by inclusion in plenary and other presentations at leading international medical professional conferences and publications in highly respected scientific journals. We look forward to working closely with the FDA in the review of this BLA and with our U.S. partner, Coherus, to bring this new treatment option forward as expeditiously as possible for patients in the U.S."

    "Toripalimab, the foundation stone of our emerging immuno-oncology franchise, demonstrated compelling efficacy in the pivotal studies supporting the BLA for nasopharyngeal carcinoma," said Denny Lanfear, Coherus CEO. "As data read out from the extensive set of pivotal clinical trials potentially supporting a broad range of additional indications, we expect toripalimab to maintain a consistently strong efficacy profile.  We will continue to work with our partner, Junshi Biosciences, to advance toripalimab through FDA approval."

    The submission is supported by the results from "POLARIS-02" and "JUPITER-02". The POLARIS-02 study is a multi-center, open-label, pivotal Phase II clinical study, results of which were published online in January 2021 in Journal of Clinical Oncology. The JUPITER-02 study is a randomized, double blind, placebo-controlled pivotal Phase 3 clinical trial, results of which were recently presented at the ASCO plenary session (#LBA2) and published in the August 2021 on-line edition of Nature Medicine.

    About Toripalimab

    Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system's ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

    In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designations for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Junshi Biosciences and Ceherus plan to file additional toripalimab BLAs with the FDA over the next three years for multiple cancers and highly prevalent cancers.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 44 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 12 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

    Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, lung cancer, or any indication; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for other clinical indications; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021

    and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

    Junshi Biosciences Contact Information

    IR Team:

    Junshi Biosciences

    info@junshipharma.com

    + 86 021-2250 0300

    Solebury Trout

    Bob Ai

    bai@soleburytrout.com

    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li

    zhi_li@junshipharma.com

    + 86 021-6105 8800

    Coherus Contact Information:

    IR Contact:

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152

    Media Contact:

    Sheryl Seapy

    Real Chemistry

    sseapy@realchemistry.com

    +1 (949) 903-4750



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  7. REDWOOD CITY, Calif., Aug. 27, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective Aug. 26, 2021, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 278,000 shares of the common stock of the Company to newly hired employees with a per share exercise price of $15.82, the closing trading price on the grant date. Two newly hired Vice Presidents were each granted options for 45,000 shares; fifteen additional non-officer employees were granted options to purchase an aggregate of 188,000 shares.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which…

    REDWOOD CITY, Calif., Aug. 27, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective Aug. 26, 2021, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 278,000 shares of the common stock of the Company to newly hired employees with a per share exercise price of $15.82, the closing trading price on the grant date. Two newly hired Vice Presidents were each granted options for 45,000 shares; fifteen additional non-officer employees were granted options to purchase an aggregate of 188,000 shares.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. For additional information, please visit www.coherus.com.

    Coherus BioSciences Contact Information:

    IR Contact

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com



    Primary Logo

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  8. – Toripalimab plus chemotherapy met primary endpoint with significant improvement in PFS compared to chemotherapy alone

    - Data support the use of toripalimab with chemotherapy as first-line therapy for patients with NSCLC -

    - Study to be presented September 13 at IASLC 2021 World Conference on Lung Cancer -

    SHANGHAI, China and REDWOOD CITY, Calif., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced positive interim results from the pivotal study "CHOICE-01" (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line…

    – Toripalimab plus chemotherapy met primary endpoint with significant improvement in PFS compared to chemotherapy alone

    - Data support the use of toripalimab with chemotherapy as first-line therapy for patients with NSCLC -

    - Study to be presented September 13 at IASLC 2021 World Conference on Lung Cancer -

    SHANGHAI, China and REDWOOD CITY, Calif., Aug. 18, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced positive interim results from the pivotal study "CHOICE-01" (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy as first-line treatment of advanced squamous or non-squamous non-small cell lung cancer (NSCLC). The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) per RECIST v1.1 compared to chemotherapy alone. 

    The results will be summarized September 13 in an oral presentation by Professor Jie Wang, MD, PhD, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, during the Mini Oral Session at the 2021 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). The abstract is now available on the WCLC website.

    "The CHOICE-01 study in patients with advanced non-small cell lung cancer has demonstrated the clinical benefit of toripalimab in yet another first-line setting, building on the evidence of efficacy in first-line studies in nasopharyngeal carcinoma and esophageal squamous cell carcinoma," said Dr. Patricia Keegan, Chief Medical Officer at Junshi Biosciences. "With an excellent clinical profile being established across multiple tumor types, we expect to pursue registration for toripalimab for a broad array of indications in China, the United States and other markets."

    "The CHOICE-01 efficacy and safety data are compelling and demonstrate the potential for toripalimab to deliver the significant benefits of the PD-1 class of checkpoint inhibitor drugs to patients with non-small cell lung cancer," said Ildiko Csiki, MD, PhD, Chair of the Coherus Scientific Advisory Board and Chief Commercial Research and Development Officer at City of Hope, a comprehensive cancer center. "As data accumulate in the pivotal studies in the broad clinical development program, toripalimab is showing itself to be an excellent checkpoint inhibitor. We eagerly anticipate results from additional Phase 3 studies in esophageal, lung, liver, breast, kidney, bladder, stomach, and skin cancers."

    About CHOICE-01

    A total of 465 treatment-naive advanced NSCLC patients (220 squamous and 245 non-squamous) were randomized (2:1): 309 to the toripalimab plus chemotherapy arm and 156 to the placebo plus chemotherapy arm. The primary endpoint of PFS was assessed by the investigator. Secondary endpoints included PFS assessed by a blinded independent review committee (BIRC), overall survival (OS), objective response rate (ORR) and duration of response (DoR). Crossover to toripalimab was allowed for patients from the placebo plus chemotherapy arm upon disease progression.

    • As of November 17, 2020 (the data cut-off date of the interim analysis), 218 PFS events were observed, with a median follow-up of 7.1 and 7.0 months in the toripalimab arm and the placebo arm, respectively.
    • At the interim analysis, a significant improvement in PFS was detected for toripalimab over placebo [hazard ratio (HR)=0.58,95% confidence interval (CI): 0.44-0.77, P=0.0001] with median PFS of 8.3 vs. 5.6 months. The 1-year PFS rates for toripalimab and placebo arms were 32.6% and 13.1%, respectively.
    • This improvement in PFS was observed in both squamous [HR = 0.55 (95% CI: 0.38-0.83)] and non-squamous [HR=0.59 (95% CI: 0.40-0.87)] NSCLC and regardless of PD-L1 expression.
    • PFS assessed by BIRC showed similar results as PFS assessed by the investigator.
    • Toripalimab in combination with chemotherapy, as compared with chemotherapy alone, resulted in better ORR (squamous NSCLC: 68.7% vs. 58.9%; non-squamous NSCLC: 58.6% versus 26.5%) and median DoR (squamous NSCLC: 6.9 months vs. 4.2 months; non-squamous NSCLC: 8.6 months vs. 5.1 months).
    • Patients in the placebo plus chemotherapy arm were actively crossed over to toripalimab treatment at the time of disease progression.
    • Overall survival data were not yet mature as of March 7, 2021. There was a trend favoring the toripalimab arm [median OS of 21.0 vs. 16.0 months, HR = 0.81 (95% CI: 0.57-1.17)].
    • The addition of toripalimab to standard first-line chemotherapy in patients with advanced NSCLC showed a manageable safety profile with no new safety signal observed. The incidence of Grade ≥3 adverse events (AEs) was 76.3% in the toripalimab arm vs. 80.1% in the control arm. AEs leading to discontinuation of toripalimab or placebo were 12.3% vs. 1.9%, respectively.

    Junshi Biosciences and Coherus plan to meet with the United States Food and Drug Administration to discuss a potential submission of a biologics license application for toripalimab for first line treatment of advanced NSCLC.

    About toripalimab

    Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system's ability to attack and kill tumor cells.

    More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. 

    In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC") and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) by US FDA in Feb 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

    Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, lung cancer, or any indication; Coherus' and Junshi Biosciences' plans to file toripalimab BLAs with the FDA over the next three years for nasopharyngeal carcinoma, lung cancer, or other clinical indications; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021, its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

    Coherus Contact Information:

    IR Contact:

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152

    Media Contact:

    Sheryl Seapy

    Real Chemistry

    sseapy@realchemistry.com

    +1 (949) 903-4750

    Junshi Biosciences Contact Information

    IR Team:

    Junshi Biosciences

    info@junshipharma.com

    + 86 021-2250 0300

    Solebury Trout

    Bob Ai

    bai@soleburytrout.com

    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li

    zhi_li@junshipharma.com

    + 86 021-6105 8800

     



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  9. SHANGHAI, China, and REDWOOD CITY, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced that the United States Food and Drug Administration ("FDA") has recently granted Breakthrough Therapy Designation ("BTD") for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC"). The FDA had earlier granted BTD for toripalimab monotherapy for patients with recurrent or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

    BTD is intended to expedite the development and regulatory…

    SHANGHAI, China, and REDWOOD CITY, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced that the United States Food and Drug Administration ("FDA") has recently granted Breakthrough Therapy Designation ("BTD") for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC"). The FDA had earlier granted BTD for toripalimab monotherapy for patients with recurrent or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

    BTD is intended to expedite the development and regulatory review of drugs where preliminary clinical evidence demonstrates substantial improvement over existing therapies for a severe or life-threating disease. Drugs with BTD will be granted closer FDA guidance – including that from senior FDA officials - and various forms of support to avail patients with new therapy as soon as possible.

    Junshi Biosciences expects to complete the biologics license application ("BLA") submission for toripalimab plus chemotherapy for 1st line NPC and for toripalimab monotherapy for 2nd or 3rd line NPC later this quarter.

    "We are pleased to have received Breakthrough Therapy designation for our novel PD-1 blocking antibody, toripalimab, for nasopharyngeal carcinoma, which is an aggressive cancer with no immuno-oncology treatment options approved in the United States," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We look forward to working closely with the FDA during the BLA review process and with our partner, Coherus, to bring toripalimab to NPC patients in the U.S., if approved."

    The Breakthrough Therapy designation is supported by data from the Phase 3 clinical trial "JUPITER-02" evaluating toripalimab in combination with chemotherapy for the first-line treatment of NPC. In this study, toripalimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression free survival ("PFS") compared to chemotherapy alone (assessed by a blinded independent review committee ("BIRC") per RECIST v1.1). JUPITER-02 also met secondary endpoints of PFS assessed by the investigator and objective response rate assessed by BIRC. There was also a longer duration of response, a higher disease control rate, and higher one- and two-year survival rates for the toripalimab arm. The safety profile of toripalimab is consistent with that observed in previously reported toripalimab clinical trials and the safety profile of this class of drugs. The result of JUPITER-02 was recently presented at the ASCO plenary session (#LBA2) and full results can be found in the August 2021 on-line edition of Nature Medicine.

    About toripalimab

    Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system's ability to attack and kill tumor cells.

    More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. 

    In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC") and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) by US FDA in Feb 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

    Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma or any indication; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for other clinical indications; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021, its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

    Coherus Contact Information:

    IR Contact:

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152

    Media Contact:

    Sheryl Seapy

    Real Chemistry

    sseapy@realchemistry.com

    +1 (949) 903-4750

    Junshi Biosciences Contact Information

    IR Team:

    Junshi Biosciences

    info@junshipharma.com

    + 86 021-2250 0300

    Solebury Trout

    Bob Ai

    bai@soleburytrout.com

    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li

    zhi_li@junshipharma.com

    + 86 021-6105 8800 



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  10. –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…

    –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

    Net product revenue, consisting of net sales of UDENYCA®, was $87.6 million and $135.7 million during the three months ended June 30, 2021 and 2020, respectively, and $170.7 million and $251.9 million during the six months ended June 30, 2021 and 2020, respectively.

    Cost of goods sold (COGS), increased to $16.7 million in the second quarter of 2021 as compared to $10.1 million in second quarter of 2020. 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 the second quarter of 2021 is the first period with per unit acquisition costs fully reflected within COGS. 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 June 30, 2021 was $54.8 million compared to $26.2 million for the same period in 2020, an increase of $28.6 million. The increase was mainly due to higher development and regulatory costs in support of the advancement of toripalimab and the biosimilar pipeline product candidates. For the six months ended June 30, 2021, R&D expense was $258.3 million compared to $59.3 million for the same period in 2020, an increase of $199.0 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 June 30, 2021 was $40.3 million compared to $34.1 million for the three months ended June 30, 2020, an increase of $6.3 million which was primarily driven by increased UDENYCA commercialization expenses including an increase in sales personnel and travel. For the six months ended June 30, 2021, SG&A expense was $79.7 million compared to $69.4 million for the same period in 2020, an increase of $10.3 million, which was primarily due to an increase of $5.8 million in stock-based compensation expense and a $4.1 million increase in UDENYCA® commercialization expenses.

    Net loss for the second quarter of 2021 was $29.9 million, or $0.40 per share on a diluted basis, compared to a net income of $59.0 million, or $0.70 per share on a diluted basis for the same period in 2020.

    Non-GAAP net loss for the second quarter of 2021 was $27.3 million, or $0.36 per share on a diluted basis, compared to non-GAAP net income of $68.3 million, or $0.81 per share on a diluted basis for the same period in 2020. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net (loss) income and a reconciliation to the most directly comparable GAAP measures.

    Cash, cash equivalents and investments in marketable securities were $454.4 million as of June 30, 2021, compared to $399.5 million at March 31, 2021.

    2021 FINANCIAL OUTLOOK

    Excluding the upfront payment made to Junshi Biosciences in the first quarter, Coherus projects full year 2021 R&D and SG&A expenses in a range of $370 million to $400 million. R&D spending is focused on development, regulatory and other activities in preparation for the potential launch of toripalimab, as well as manufacturing-related and regulatory activities for CHS-1420, development activities for CHS-305, and additional presentations of UDENYCA®. Increases in SG&A spending in 2021 are primarily driven by marketing activities and headcount to support UDENYCA and the potential launches in 2022 of toripalimab and CHS-201 (Lucentis biosimilar).

    This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below and the section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 to be filed with the Securities & Exchange Commission on August 5, 2021.

    Conference Call Information

    When: Thursday, August 5, 2021 starting at 5:00 p.m. ET

    Dial-in: (844) 452-6826 (Toll-Free U.S. and Canada) or (765) 507-2587 (International)

    Conference ID: 9146617

    Webcast: https://investors.coherus.com/upcoming-events 

    Please dial-in 15 minutes early to ensure a timely connection to the call.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to maintain UDENYCA® market share and position as leading pegfilgrastim biosimilar in the United States; Coherus' ability to generate increased revenue from its UDENYCA business with anticipated market share growth, assuming treatment patterns begin to normalize as the general population is vaccinated against COVID-19; Coherus' ability to expand its addressable market opportunity and to lay the foundation for long-term growth across its biosimilar product portfolio and immuno-oncology product pipeline; Coherus' ability to advance the Company's oncology biosimilar candidate to Avastin® (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, the timing of required interactions with the FDA; the risk that the product may not be approved on time, if at all; Coherus' ability to launch Innovent's biosimilar candidate to Avastin® in the United States; Coherus' ability to facilitate Bioeq's resubmission of a BLA with the FDA for the ophthalmology biosimilar candidate to Lucentis® (ranibizumab) in mid-2021 and Coherus' ability to launch the product, if approved; Coherus' ability to facilitate Junshi Biosciences' submission of a toripalimab BLA with the FDA for nasopharyngeal carcinoma in 2021 and for additional indications, including lung cancer, over the next three years; the timing of the FDA's approval decision for CHS-1420, a Humira® (adalimumab) biosimilar, and the risk that the product may not be approved on time, if at all; Coherus' ability to continue other CHS-1420 activities to advance toward a projected market entry in the United States on or after July 1, 2023; and Coherus' ability to meet its R&D and SG&A expenses guidance for the full fiscal year 2021. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, to be filed with the Securities and Exchange Commission on August 5, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

    Coherus BioSciences, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

    (unaudited)

                  
         Three Months Ended Six Months Ended 
      June 30, June 30, 
      2021  2020  2021  2020  
    Revenue:             
    Net product revenue $87,643  $135,674  $170,677  $251,854  
    Operating expenses:             
    Cost of goods sold  16,696   10,139   24,207   16,994  
    Research and development  54,766   26,173   258,258   59,280  
    Selling, general and administrative  40,345   34,052   79,736   69,402  
    Total operating expenses  111,807   70,364   362,201   145,676  
    (Loss) Income from operations  (24,164)  65,310   (191,524)  106,178  
    Interest expense  (5,747)  (5,408)  (11,395)  (9,839) 
    Other income, net  11   423   72   491  
    Net (loss) income before income taxes  (29,900)  60,325   (202,847)  96,830  
    Income tax provision     1,294      2,227  
    Net (loss) income $(29,900) $59,031  $(202,847) $94,603  
                  
    Net (loss) income per share:             
    Basic $(0.40) $0.83  $(2.73) $1.33  
    Diluted $(0.40) $0.70  $(2.73) $1.20  
                  
    Weighted-average number of shares used in computing net (loss) income per share:             
    Basic  75,559,697   71,099,773   74,203,858   70,880,979  
    Diluted  75,559,697   88,660,280   74,203,858   83,775,353  

    Coherus BioSciences, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

            
         June 30,    December 31, 
      2021 2020 
    Assets       
    Cash and cash equivalents $329,738 $541,158 
    Investments in marketable securities  124,683   
    Trade receivables, net  141,825  157,046 
    Inventory  96,081  92,189 
    Other assets  47,215  51,256 
    Total assets $739,542 $841,649 
    Liabilities and Stockholders' Equity       
    Accrued rebates, fees and reserves $83,758 $81,529 
    Convertible notes due 2022*  80,605  79,885 
    Convertible notes due 2022 - related parties*  26,868  26,628 
    Convertible notes due 2026  223,655  223,029 
    Term loan - current portion  11,538   
    Term loan-non - current portion  63,420  74,481 
    Other liabilities  93,478  75,123 
    Total stockholders' equity  156,220  280,974 
    Total liabilities and stockholders' equity $739,542 $841,649 
            

    * The Convertible notes due 2022 and the Convertible notes due 2022 - related parties were classified in current liabilities as of June 30, 2021 and in non-current liabilities as of December 31, 2020.

    Coherus BioSciences, Inc.

    Condensed Consolidated Cash Flow

    (in thousands)

    (unaudited)

         Three Months Ended Six Months Ended 
      June 30, June 30, 
      2021  2020  2021  2020  
    Cash, cash equivalents and restricted cash at beginning of the period $259,929  $193,692  $541,598  $177,908  
                  
    Net cash (used in) provided by operating activities $(188) $60,191  $1,179  $73,668  
                  
    Purchases of investments in marketable securities     (231,864)  (140,330)  (231,864) 
    Proceeds from maturities of investments in marketable securities  15,000      15,000     
    Upfront license fee payments*  9,000   (5,000)  (136,000)  (5,000) 
    Cash used in other investing activities  (415)  (2,384)  (560)  (4,000) 
    Net cash provided by (used in) investing activities $23,585  $(239,248) $(261,890) $(240,864) 
                  
    Proceeds from issuance of Convertible Notes due 2026, net of issuance costs     222,830      222,830  
    Purchase of capped call options related to convertible notes due 2026     (18,170)     (18,170) 
    Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs  40,903      40,903     
    Proceeds from issuance of common stock upon exercise of stock options  4,117   3,302   8,446   8,105  
    Proceeds from purchase under the employee stock purchase plan  1,985   2,557   1,985   2,557  
    Cash used in other financing activities  (153)  (97)  (2,043)  (977) 
    Net cash provided by financing activities $46,852  $210,422  $49,291  $214,345  
                  
    Net increase in cash, cash equivalents and restricted cash $70,249  $31,365  $(211,420) $47,149  
                  
    Cash, cash equivalents and restricted cash at end of the period $330,178  $225,057  $330,178  $225,057  
                  
    Reconciliation of cash, cash equivalents, and restricted cash             
    Cash and cash equivalents $329,738   224,617  $329,738   224,617  
    Restricted cash balance  440   440   440   440  
    Cash, cash equivalents and restricted cash $330,178  $225,057  $330,178  $225,057  

    * 2021 payments includes license fees of $145.0 million pursuant to the collaboration agreement with Junshi Biosciences paid in the first quarter which was partially offset by a $9.0 million credit related to the fair value of the discount for lack of marketability on the common shares purchased under the stock purchase agreement with Junshi Biosciences in the second quarter.

    Non-GAAP Financial Measures

    To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net income, and the related per share measures, which exclude from net (loss) income, and the related per share measures, stock-based compensation expense, upfront and milestone payments under the license agreements, costs related to termination of a research and development program as part of a strategic realignment of research and development resources toward other development programs and the related income tax effect of those non-GAAP adjustments. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus' business.

    Coherus believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare Coherus' results from period to period, and to identify operating trends in Coherus' business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.

    Coherus BioSciences, Inc.

    Reconciliation of GAAP Net (Loss) Income to Non-GAAP Net (Loss) Income

    (in thousands, except share and per share data)

    (unaudited)

         Three Months Ended Six Months Ended 
      June 30, June 30, 
      2021  2020  2021  2020  
    GAAP net (loss) income $(29,900) $59,031  $(202,847) $94,603  
    Adjustments:             
    Stock-based compensation expense  11,595   9,425   28,479   18,980  
    Upfront license fees*  (9,000)     136,000   5,000  
    Costs related to termination of CHS-2020 development program        11,503     
    Income tax effect of the above adjustments     (202)     (552) 
    Non-GAAP net (loss) income $(27,305) $68,254  $(26,865) $118,031  
                  
    GAAP net (loss) income per share, basic $(0.40) $0.83  $(2.73) $1.33  
    GAAP net (loss) income per share, diluted $(0.40) $0.70  $(2.73) $1.20  
    Non-GAAP net (loss) income per share, basic $(0.36) $0.96  $(0.36) $1.67  
    Non-GAAP net (loss) income per share, diluted $(0.36) $0.81  $(0.36) $1.48  
    Shares used in computing basic net (loss) income per share  75,559,697   71,099,773   74,203,858   70,880,979  
    Shares used in computing diluted net (loss) income per share  75,559,697   88,660,280   74,203,858   83,775,353  

    * 2021 expense includes license fees of $145.0 million pursuant to the collaboration agreement with Junshi Biosciences expensed in the first quarter which was partially offset by a $9.0 million credit related to the fair value of the discount for lack of marketability on the common shares purchased under the stock purchase agreement with Junshi Biosciences in the second quarter.

    Contact

    McDavid Stilwell

    Chief Financial Officer

    Coherus BioSciences, Inc.

    IR@coherus.com

    +1 (650) 395-0152

     



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  11. REDWOOD CITY, Calif., July 26, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that its second quarter 2021 financial results will be released after market close on Thursday, August 5, 2021. Starting at 5 p.m. ET, Coherus' management team will host a conference call and webcast to discuss financial results and provide a general business update.

    After releasing second quarter financial results, the Company will post them on the Coherus website at https://investors.coherus.com.

    Conference Call Information

    When: Thursday, August 5, 2021 starting at 5:00 p.m. ET

    Dial-in: (844) 452-6826 (Toll-Free U.S. and Canada) or (765) 507-2587 (International)

    Conference ID: 9146617

    Webcast: https://investors.coherus.com/upcoming-events

    REDWOOD CITY, Calif., July 26, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that its second quarter 2021 financial results will be released after market close on Thursday, August 5, 2021. Starting at 5 p.m. ET, Coherus' management team will host a conference call and webcast to discuss financial results and provide a general business update.

    After releasing second quarter financial results, the Company will post them on the Coherus website at https://investors.coherus.com.

    Conference Call Information

    When: Thursday, August 5, 2021 starting at 5:00 p.m. ET

    Dial-in: (844) 452-6826 (Toll-Free U.S. and Canada) or (765) 507-2587 (International)

    Conference ID: 9146617

    Webcast: https://investors.coherus.com/upcoming-events

    Please dial-in 15 minutes early to ensure a timely connection to the call.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. For additional information, please visit www.coherus.com.



    Contact Information:
    Investor Contact:
    McDavid Stilwell, CFO
    Coherus BioSciences, Inc.
    IR@coherus.com

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  12. REDWOOD CITY, Calif., July 21, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced the appointment of Ildiko Csiki, M.D., Ph.D., a leader in the field of immuno-oncology research and drug development, as Chair of its Scientific Advisory Board (SAB). With Dr. Csiki as Chair, Coherus' SAB will work closely with Coherus leadership to build a world-class immuno-oncology franchise that offers life-changing medicines to patients. In collaboration with Junshi Biosciences, Coherus is developing toripalimab, a PD-1 blocking antibody, in an extensive registrational development program for a broad range of tumor types, as well as in combination with other immuno-oncology targeting agents.

    "We are honored to have…

    REDWOOD CITY, Calif., July 21, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced the appointment of Ildiko Csiki, M.D., Ph.D., a leader in the field of immuno-oncology research and drug development, as Chair of its Scientific Advisory Board (SAB). With Dr. Csiki as Chair, Coherus' SAB will work closely with Coherus leadership to build a world-class immuno-oncology franchise that offers life-changing medicines to patients. In collaboration with Junshi Biosciences, Coherus is developing toripalimab, a PD-1 blocking antibody, in an extensive registrational development program for a broad range of tumor types, as well as in combination with other immuno-oncology targeting agents.

    "We are honored to have Dr. Csiki as Chair of our Scientific Advisory Board. As a highly regarded and successful physician-scientist, she has made significant contributions to the development of several cancer immunotherapies, including pembrolizumab," said Denny Lanfear, CEO of Coherus. "Over the next several years, as we advance toripalimab in multiple therapeutic indications toward registrations in the US and build out our broader immuno-oncology franchise, her expertise and scientific insights will be essential to our development and commercialization strategies. Dr. Csiki joins our existing SAB which includes distinguished members from top institutions who have made significant contributions to the immuno-oncology field."

    "I look forward to working with Coherus' SAB to help define an optimal approach to developing and commercializing a potentially broad immuno-oncology portfolio, starting with toripalimab, both as monotherapy and in potential combination with complementary agents such as anti-TIGIT antibodies, eIL-2 cytokines, and other immuno-oncology targets," said Dr. Csiki, Chief Commercial Research and Development Officer at City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases.

    Before joining City of Hope, a National Cancer Institute-designated comprehensive cancer center, Dr. Csiki served as the chief medical officer at Sensei Biotherapeutics, where she was responsible for the clinical strategy for the discovery and development of cancer immunotherapies. Prior to that, Dr. Csiki served as Vice President of Immuno-Oncology Clinical Development at Inovio Pharmaceuticals where she led the advancement of Inovio's DNA-based cancer immunotherapies. She also held clinical development lead roles at Merck responsible for pembrolizumab (Keytruda®) development in multiple indications as well as at GSK focused on multiple assets for various cancer programs. Dr Csiki began her post-graduate career at the University of Pennsylvania, Perelman School of Medicine as a tenure-track physician scientist in the Department of Radiation Oncology. She earned an M.D. and Ph.D. in cancer biology from the Vanderbilt University School of Medicine. Her postdoctoral training included an internship in Internal Medicine and residency in radiation oncology at Vanderbilt and subsequently, a Holman Pathway Research Fellowship. She is also a General Management Program graduate from the Wharton Business School with focus in strategic innovation and entrepreneurship.

    The Coherus Scientific Advisory Board

    Ildiko Csiki, M.D., Ph.D.

    Chief Commercial Research and Development Officer at City of Hope

    Thomas Graeber, Ph.D.

    Professor, Molecular and Medical Pharmacology, Director, UCLA Metabolomics Center

    Michael J. Gresser, Ph.D.

    Previous Senior Executive at Amgen and Merck

    Samir N. Khleif, M.D.

    Biomedical Scholar Professor, Georgetown University

    Ravindra Majeti, M.D., Ph.D.

    Professor of Medicine (Hematology), Chair - Division of Hematology, Stanford University School of Medicine

    Carl F. Ware, Ph.D.

    Director, Sanford-Burnham Medical Research Institute

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' ability to develop and to commercialize toripalimab; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risk that the parties are unable to obtain clearance under the Hart-Scott Rodino Antitrust Improvements Act, from the Committee on Foreign Investment in the United States, or any other statute or regulatory agency having jurisdiction with respect to the proposed transactions, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Quarterly Report on Form 10-Q for the three months ended March 31, 2021, to be filed with the Securities and Exchange Commission on May 6, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended March 31, 2021 are not necessarily indicative of our operating results for any future periods.

     



    Coherus IR and Media Contact:
    McDavid Stilwell, CFO
    Coherus BioSciences, Inc.
    mstilwell@coherus.com
    +1 (650) 395-0152

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  13. REDWOOD CITY, Calif., July 12, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective July 6, 2021, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 221,500 shares of the common stock of the Company to newly hired employees with a per share exercise price of $13.63, the closing trading price on the grant date. A newly hired Vice President was granted options for 45,000 shares; fourteen additional non-officer employees were granted options to purchase an aggregate of 176,500 shares.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was…

    REDWOOD CITY, Calif., July 12, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective July 6, 2021, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 221,500 shares of the common stock of the Company to newly hired employees with a per share exercise price of $13.63, the closing trading price on the grant date. A newly hired Vice President was granted options for 45,000 shares; fourteen additional non-officer employees were granted options to purchase an aggregate of 176,500 shares.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. For additional information, please visit www.coherus.com.



    Coherus BioSciences Contact Information:
    
    IR Contact
    McDavid Stilwell
    Coherus BioSciences, Inc.
    mstilwell@coherus.com

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  14. SHANGHAI, China, and REDWOOD CITY, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced that the companies will host a virtual investor event on Monday, June 7, 2021 at 6 p.m. Eastern Time to discuss toripalimab clinical data from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

    Key highlights will include a discussion of toripalimab discovery and early development, a review of data presented at ASCO, including the results of the JUPITER-02 clinical trial evaluating toripalimab for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, and an overview…

    SHANGHAI, China, and REDWOOD CITY, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced that the companies will host a virtual investor event on Monday, June 7, 2021 at 6 p.m. Eastern Time to discuss toripalimab clinical data from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

    Key highlights will include a discussion of toripalimab discovery and early development, a review of data presented at ASCO, including the results of the JUPITER-02 clinical trial evaluating toripalimab for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, and an overview of the broad toripalimab clinical development program and strategy for marketing authorization. Event participants will include the following:

    • Dr. RuiHua Xu, President and Professor at Sun Yat-sen University Cancer Center
    • Dr. Sheng Yao, Senior Vice President of Junshi Biosciences
    • Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences
    • Denny Lanfear, Chief Executive Officer of Coherus

    Conference Call Information

    When: Monday, June 7, 2021 at 6:00 p.m. Eastern Time

    Dial-in:

    (844) 452-6826 (Toll-Free U.S. and Canada)

    (765) 507-2587 (International)

    4006828609 (China)  

    8008700169 (China, Domestic)            



    Conference ID: 3757914

    Webcast: https://investors.coherus.com/upcoming-events

    Please dial-in/login 15 minutes early to ensure a timely connection to the call. An archived edition of the event will be available later that day.

    A slide presentation will be posted prior to the event to the Investors section of the Coherus website.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) by US FDA in Feb 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021, its Quarterly Report on Form 10-Q for the three and nine months ended March 31, 2021, filed with the Securities and Exchange Commission on May 6, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission.



    Coherus Contact Information:
    IR Contact:
    McDavid Stilwell
    Coherus BioSciences, Inc.
    mstilwell@coherus.com
    +1 (650) 395-0152
    
    Media Contact:
    Sheryl Seapy
    Real Chemistry
    sseapy@realchemistry.com
    (949) 903-4750
    
    Junshi Biosciences Contact Information
    
    IR Team:
    Junshi Biosciences
    info@junshipharma.com
    + 86 021-2250 0300
    
    Solebury Trout
    Bob Ai
    bai@soleburytrout.com
    + 1 646-389-6658
    
    PR Team:
    Junshi Biosciences
    Zhi Li
    zhi_li@junshipharma.com
    + 86 021-6105 8800 

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  15. – In pivotal Phase 3 JUPITER-02 study, toripalimab plus chemotherapy significantly improved PFS compared to chemotherapy alone in high and low PD-L1 expression subgroups –

    –  Although median overall survival (OS) analysis was not yet mature, a 40% reduction in risk of death was observed in the toripalimab arm compared to placebo –

    – Data to be presented June 6, 2021 at ASCO plenary session –

    – Over 30 toripalimab abstracts in more than 10 tumor types published at ASCO 2021 –

    SHANGHAI, China, and REDWOOD CITY, Calif., June 03, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced positive results from the pivotal…

    – In pivotal Phase 3 JUPITER-02 study, toripalimab plus chemotherapy significantly improved PFS compared to chemotherapy alone in high and low PD-L1 expression subgroups –

    –  Although median overall survival (OS) analysis was not yet mature, a 40% reduction in risk of death was observed in the toripalimab arm compared to placebo –

    – Data to be presented June 6, 2021 at ASCO plenary session –

    – Over 30 toripalimab abstracts in more than 10 tumor types published at ASCO 2021 –

    SHANGHAI, China, and REDWOOD CITY, Calif., June 03, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced positive results from the pivotal study "JUPITER-02", a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival (PFS) compared to chemotherapy alone (assessed by a blinded independent review committee, or BIRC, per RECIST v1.1). JUPITER-02 also met secondary endpoints of PFS assessed by the investigator and objective response rate (ORR) assessed by BIRC. There was also a longer duration of response (DoR), a higher disease control rate (DCR) and higher one- and two-year survival rates for the toripalimab arm. The safety profile of toripalimab was consistent with that observed in previously reported toripalimab clinical trials.

    The results are summarized in a late-breaking abstract that will be presented during a plenary session at the 2021 annual meeting of the American Society for Clinical Oncology (ASCO) on Sunday, June 6, 2021 from 1–4 pm Eastern Daylight Time. The abstract (LBA2) is now available on the ASCO website.

    "Nasopharyngeal carcinoma is an aggressive tumor—especially for patients with advanced NPC. For first line treatment, platinum-based chemotherapy remains the current standard of care, yet mPFS is only about 7 months. We are encouraged by the JUPITER-02 results showing the addition of toripalimab to chemotherapy as first-line treatment provided superior PFS and ORR and longer DoR than chemotherapy alone, and with a safety and tolerability profile consistent with the PD-1 antibody class of drugs," said Dr. Ruihua Xu, President and Professor, Sun Yat-sen University Cancer Center (SYSUCC), Guangzhou. "I believe that these results support the use of toripalimab with chemotherapy as the new standard of care for first-line treatment of patients with recurrent/metastatic NPC."

    More than 30 toripalimab abstracts were accepted for ASCO 2021, including two selected for oral presentations (LBA2 and #9512), describing the antitumor activities observed from various cancers of the nasopharynx, skin, lung, esophagus, stomach, liver, biliary duct, head and neck, and pancreas. Importantly, ten of the abstracts demonstrated toripalimab's potential in perioperative, adjuvant, or neoadjuvant treatment settings.

    "Given the outstanding results, JUPITER-02 is the first study to show a major therapeutic advance for first-line treatment of advanced NPC since the chemotherapy combination of gemcitabine and cisplatin was established as standard of care, which is why I believe this study was selected for presentation at the plenary session at ASCO 2021. We will work to expedite commercialization of toripalimab for this patient population in China, the United States, and other countries to make this exciting new treatment option broadly available to all patients with NPC," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "In addition to the JUPITER-02 trial, results of multiple other studies of toripalimab will be presented during the ASCO annual meeting, which support the current development strategy, such as perioperative immunotherapy in patients with multiple solid tumors, including mucosal melanoma, esophageal cancer, gastric cancer, liver cancer and non-small cell lung cancer, as well as the exploration of toripalimab for treatment of ICC, for which no checkpoint inhibitors have been approved for use."

    "ASCO 2021 is a pivotal moment for Coherus as it marks the U.S. medical meeting debut of the immuno-oncology franchise we are building to deliver life-changing medicines addressing both rare and highly prevalent cancers," said Denny Lanfear, CEO of Coherus. "The strong late-breaking data in advanced NPC add to the favorable efficacy and safety profile that is emerging for toripalimab in the broad development program with more than 15 pivotal clinical trials. Alongside Junshi Biosciences, we look forward to presenting clinical data from these studies and to working together to register toripalimab in the United States and Canada as a potential new therapeutic option across a broad range of tumor types, starting with NPC."

    About JUPITER-02 Results

    JUPITER-02, conducted in mainland China, Taiwan and Singapore, is the largest Phase 3 clinical study to evaluate a checkpoint inhibitor plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma. Two hundred eighty-nine patients with advanced NPC who had received no prior chemotherapy for recurrent/metastatic disease were randomized 1:1 to receive toripalimab 240 mg or placebo in combination with gemcitabine 1000 mg/m2 (d1, 8) and cisplatin 80 mg/m2 (d1), Q3W followed by toripalimab or placebo monotherapy until disease progression, intolerable toxicity or completion of two years of treatment. Progression-free survival and response were assessed by the BIRC and by the investigator per RECIST v1.1. There was one pre-specified interim analysis of PFS at 130 (65%) PFS events with a planned final analysis at 200 PFS events.

    By May 30, 2020, the date of the interim analysis data cut, the median treatment duration was 39 weeks in the toripalimab arm and 36 weeks in the placebo arm. The ASCO presentation also includes an updated overall survival (OS) analysis with a data cut-off of February 18, 2021.

    A summary of the results is as follows:

    • A significant improvement in PFS (assessed by BIRC) was observed in the toripalimab plus chemotherapy arm compared to the chemotherapy alone arm (HR = 0.52 [95% CI: 0.36-0.74] two-sided p = 0.0003), median PFS of 11.7 vs. 8.0 months;
    • The 1-year PFS rates were 49% and 28%, respectively, for the toripalimab arm compared to the placebo arm;
    • An improvement in PFS was observed across relevant subgroups including patients with high PD-L1 expression (TC or IC ≥ 1%; mPFS 11.4 vs. 8.2 month, HR = 0.59 [95% CI: 0.388 – 0.893]) or low PD-L1 expression (TC and IC<1%; mPFS 11.0 vs. 6.0 months, HR=0.35 [95% CI: 0.153 – 0.808]);
    • The ORR was 77.4% vs. 66.4% (P = 0.034); the median DoR was 10.0 vs. 5.7 months (HR = 0.50 [95% CI: 0.33-0.78]), P = 0.001);
    • The first interim analysis of overall survival was not mature at the interim analysis of PFS. In the updated OS analysis conducted February 18, 2021, although median OS was not yet mature in either arm, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.60 [95% CI: 0.364-0.997], nominal P = 0.046);
    • The incidence of grade ≥3 treatment emergent adverse events (TEAEs) (89.0% vs 89.5%), grade ≥3 treatment related adverse events (TRAE) (80.8% vs 83.2%), AEs leading to discontinuation of toripalimab/placebo (7.5% vs 4.9%), and fatal AEs (2.7% vs 2.8%) was similar between both arms. Immune-related (irAEs) (39.7% vs. 18.9%) and Grade ≥3 irAEs (7.5% vs. 0.7%) were more frequent in the toripalimab group.

    A pre-specified second interim OS analysis will be performed at the same time as the final PFS analysis.

    About toripalimab

    Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system's ability to attack and kill tumor cells.

    More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. 

    In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) by US FDA in Feb 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma or any indication; toripalimab's possibility to be the first marketed Chinese anti-PD-1 antibody in the overseas market; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for any clinical indication; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 27, 2020, its Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020, filed with the Securities and Exchange Commission on November 5, 2020 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended September 30, 2020 are not necessarily indicative of our operating results for any future periods.



    Coherus Contact Information:
    IR Contact:
    McDavid Stilwell
    Coherus BioSciences, Inc.
    mstilwell@coherus.com
    +1 (650) 395-0152
    
    Media Contact:
    Sheryl Seapy
    Real Chemistry
    sseapy@realchemistry.com
    (949) 903-4750
    
    Junshi Biosciences Contact Information
    
    IR Team:
    Junshi Biosciences
    info@junshipharma.com
    + 86 021-2250 0300
    
    Solebury Trout
    Bob Ai
    bai@soleburytrout.com
    + 1 646-389-6658
    
    PR Team:
    Junshi Biosciences
    Zhi Li
    zhi_li@junshipharma.com
    + 86 021-6105 8800 

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  16. REDWOOD CITY, Calif., May 07, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that senior management will present at the upcoming Bank of America Health Care Conference on Wednesday, May 12, 2021 at 1:15 p.m. EST / 10:15 a.m. PST.

    The audio portion of the Company presentation will be available on the investors page of the Coherus BioSciences website at https://investors.coherus.com.

    About Coherus BioSciences
    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. For additional information, please visit www.coherus.com.

    REDWOOD CITY, Calif., May 07, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that senior management will present at the upcoming Bank of America Health Care Conference on Wednesday, May 12, 2021 at 1:15 p.m. EST / 10:15 a.m. PST.

    The audio portion of the Company presentation will be available on the investors page of the Coherus BioSciences website at https://investors.coherus.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. For additional information, please visit www.coherus.com.

    Contact

    McDavid Stilwell

    CFO

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152



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  17. – 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…

    – 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 expected later in 2021.

    CHS-201, a biosimilar Lucentis® (ranibizumab) product candidate in collaboration with Bioeq AG:

    • Bioeq AG expects to file the CHS-201 BLA mid-year 2021, following a supportive pre-BLA meeting with the FDA earlier in the first quarter of 2021. Bioeq reviewed new manufacturing data with the FDA, which the agency requested last year, as well as other elements of the BLA filing.

    CHS-1420, a wholly owned biosimilar Humira® (adalimumab) product candidate:

    • The FDA accepted for review the BLA for CHS-1420 and assigned a target action date in December 2021. The FDA has completed the on-site portion of the pre-approval drug substance CMC inspection, with no Form 483s being issued. 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 initiated the three-way pharmacokinetic study to facilitate the potential BLA submission. Recruitment into the study has been slower than expected as a result of the COVID-19 pandemic, and Coherus now expects data from this study around year end 2021.

    Coherus is planning an analyst day event in the fourth quarter of 2021.

    FIRST QUARTER 2021 FINANCIAL RESULTS

    Net product revenue, consisting of net sales of UDENYCA®, was $83 million for the first quarter of 2021. Net Product revenue declined in comparison to the prior quarter and the first quarter of 2020 due to an increase in discounts and allowances, as well as a reduction in ex-factory units sold due to seasonal fluctuations in wholesale inventory levels in the fourth quarter of 2020 and the first quarter of 2021.  

    Research and development (R&D) expenses for the first quarter of 2021 were $203.5 million, compared to $33.1 million for the same period in 2020. The increase was mainly due to the $145 million upfront payment to Junshi Biosciences upon the closing of the collaboration agreement in March, the $11.5 million charge related to the termination of the CHS-2020 program, and higher development costs in support of the advancement of toripalimab and the biosimilar pipeline product candidates.

    Selling, general and administrative (SG&A) expenses were $39.4 million in the first quarter of 2021 as compared to $35.4 million in the year ago quarter. The increase was primarily driven by an increase in stock based compensation expense.

    Net loss for the first quarter of 2021 was $172.9 million, or $2.37 per share on a diluted basis, compared to a net income of $35.6 million, or $0.48 per share on a diluted basis for the same period in 2020.

    Non-GAAP net income for the first quarter of 2021 was $0.4 million, or $0.01 per share on a diluted basis, compared to non-GAAP net income of $49.8 million, or $0.67 per share on a diluted basis for the same period in 2020. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measures.

    Cash, cash equivalents and investments in marketable securities were $399.5 million as of March 31, 2021, compared to $541.2 million at year end 2020. Subsequent to quarter end, Coherus received $50 million from Junshi Biosciences' acquisition of 2,491,988 shares at a price per share of $20.06.

    2021 FINANCIAL OUTLOOK

    Coherus expects UDENYCA® revenue and market penetration to rise in the second half of 2021, assuming the COVID-19 pandemic recedes and treatment patterns normalize, and subject to pricing trends in the overall pegfilgrastim market.

    Excluding the $145 million upfront payment made to Junshi Biosciences in the first quarter, Coherus projects full year R&D and SG&A expenses in a range of $370 million to $400 million. External R&D spending is focused on manufacturing-related activities in preparation for the potential launch of toripalimab and CHS-1420, if approved, and development activities for CHS-305 and for additional presentations of UDENYCA®. Increases in SG&A spending in 2021 are primarily driven by marketing activities and headcount to support UDENYCA and the potential launches in 2022 of toripalimab and CHS-201 (Lucentis biosimilar).

    This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below and the section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 to be filed with the Securities & Exchange Commission on May 6, 2021.

    Conference Call Information

    When: Thursday, May 6, 2021 starting at 4:30 p.m. ET

    Dial-in: (800) 446-2782 (Toll-Free U.S. and Canada) or (847) 413-3235 (International)

    Conference ID: 50149707

    Webcast: https://investors.coherus.com/upcoming-events

    Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to maintain UDENYCA® market share and position as leading pegfilgrastim biosimilar in the United States; Coherus' ability to generate increased revenue from its UDENYCA business® with anticipated market share growth, assuming treatment patterns begin to normalize as the general population is vaccinated against COVID-19; Coherus' ability to expand its addressable market opportunity and to lay the foundation for long-term growth across its biosimilar product portfolio and immuno-oncology product pipeline; Coherus' ability to advance the Company's oncology biosimilar candidate to Avastin® (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, depending on the outcome of the three-way PK study, the timing of required interactions with the FDA; Coherus' ability to launch Innovent's biosimilar candidate to Avastin® in the United States; Coherus' ability to facilitate Bioeq's resubmission of a BLA with the FDA for the ophthalmology biosimilar candidate to Lucentis® (ranibizumab) in mid-2021 and Coherus' ability to launch the product, if approved; Coherus' ability to facilitate Junshi Biosciences' submission of a toripalimab BLA with the FDA for nasopharyngeal carcinoma in 2021 and for additional indications, including lung cancer, over the next three years; the timing of the FDA's approval decision for CHS-1420, a Humira® (adalimumab) biosimilar, and the risk that the product may not be approved on time, if at all; Coherus' ability to continue other CHS-1420 activities to advance toward a projected market entry in the United States on or after July 1, 2023; and Coherus' ability to meet its R&D and SG&A expenses guidance for the full fiscal year 2021. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Quarterly Report on Form 10-Q for the three months ended March 31, 2021, to be filed with the Securities and Exchange Commission on May 6, 2021 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended March 31, 2021 are not necessarily indicative of our operating results for any future periods.





    Coherus BioSciences, Inc. 
    Condensed Consolidated Statements of Operations 
    (in thousands, except share and per share data) 
    (unaudited) 
           
     Three Months Ended 
     March 31, 
     2021  2020  
    Revenue:        
    Net product revenue$83,034  $116,180  
    Operating expenses:      
    Cost of goods sold 7,511   6,855  
    Research and development 203,492   33,107  
    Selling, general and administrative 39,391   35,350  
    Total operating expenses 250,394   75,312  
    (Loss) Income from operations (167,360)  40,868  
    Interest expense (5,648)  (4,431) 
    Other income, net 61   68  
    Net (loss) income before income taxes (172,947)  36,505  
    Income tax provision    933  
    Net (loss) income$(172,947) $35,572  
             
    Net (loss) income per share:        
    Basic$(2.37) $0.50  
    Diluted$(2.37) $0.48  
           
    Weighted-average number of shares used in computing net (loss) income per share:       
    Basic 72,832,953   70,662,185  
    Diluted 72,832,953   74,416,554  
           





    Coherus BioSciences, Inc. 
    Condensed Consolidated Balance Sheets 
    (in thousands) 
    (unaudited) 
           
      March 31,  December 31, 
      2021  2020 
    Assets       
    Cash and cash equivalents$259,489 $541,158 
    Investments in marketable securities 140,014  - 
    Trade receivables, net 140,410  157,046 
    Inventory 103,678  92,189 
    Other assets 49,712  51,256 
    Total assets$693,303 $841,649 
    Liabilities and Stockholders' Equity      
    Accrued rebates, fees and reserve$78,202 $81,529 
    Convertible notes due 2022* 80,240  79,885 
    Convertible notes due 2022 - related parties* 26,747  26,628 
    Convertible notes due 2026 223,341  223,029 
    Term loan 74,696  74,481 
    Other liabilities 82,406  75,123 
    Total stockholders' equity 127,671  280,974 
    Total liabilities and stockholders' equity$693,303 $841,649 
           
    * The Convertible notes due 2022 and the Convertible notes due 2022 - related parties were classified in current liabilities as of March 31, 2021 and in non-current liabilities as of December 31, 2020. 
           





    Coherus BioSciences, Inc. 
    Condensed Consolidated Cash Flow 
    (in thousands) 
    (unaudited) 
         
     Three Months Ended  
     March 31, 
      2021   2020  
    Cash, cash equivalents and restricted cash at beginning of the period$ 541,598  $ 177,908  
         
    Net cash provided by operating activities$ 1,367  $ 13,477  
         
    Purchases of investments in marketable securities (140,330)    
    Upfront license fee payment to Junshi Biosciences (145,000)    
    Purchases of property and equipment and other investing activities (145)  (1,616) 
    Net cash used in investing activities$ (285,475) $ (1,616) 
         
    Proceeds from issuance of common stock upon exercise of stock options 4,329   4,803  
    Taxes paid related to net share settlement of RSUs (1,730)  (880) 
    Other immaterial financing activities (160)    
    Net cash provided by financing activities$ 2,439  $ 3,923  
         
    Net (decrease) increase in cash, cash equivalents and restricted cash$ (281,669) $ 15,784  
         
    Cash, cash equivalents and restricted cash at end of the period$ 259,929  $ 193,692  
         
    Reconciliation of cash, cash equivalents, and restricted cash    
    Cash and cash equivalents$259,489  $193,252  
    Restricted cash – non-current 440   440  
    Cash, cash equivalents and restricted cash$259,929  $193,692  
         



    Non-GAAP Financial Measures

    To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net income, and the related per share measures, which exclude from net income, and the related per share measures, stock-based compensation expense, upfront and milestone payments under the license agreements, costs related to termination of a research and development program as part of a strategic realignment of research and development resources toward other development programs and the related income tax effect of those non-GAAP adjustments. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus' business.

    Coherus believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare Coherus' results from period to period, and to identify operating trends in Coherus' business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.



    Coherus BioSciences, Inc.

    Reconciliation of GAAP Net (Loss) Income to Non-GAAP Net Income

    (in thousands, except share and per share data)

    (unaudited)
           
      Three Months Ended
      March 31,
         2021     2020 
    GAAP net (loss) income $(172,947) $35,572 
    Adjustments:      
    Stock based compensation expense  16,884   9,555 
    Upfront license fees expense  145,000   5,000 
    Costs related to termination of CHS-2020 development program  11,503    
    Income tax effect of the above adjustments  (24)  (362)
    Non-GAAP net income $416  $49,765 
           
    GAAP net (loss) income per share, basic $(2.37) $0.50 
    GAAP net (loss) income per share, diluted $(2.37) $0.48 
    Non-GAAP net income per share, basic $0.01  $0.70 
    Non-GAAP net income per share, diluted $0.01  $0.67 



    Contact


    McDavid Stilwell

    Chief Financial Officer

    Coherus BioSciences, Inc.

    IR@coherus.com

    +1 (650) 395-0152



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  18. REDWOOD CITY, Calif., April 30, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective April 28, 2021, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 483,000 shares of the common stock of the Company to newly hired employees with a per share exercise price of $14.76, the closing trading price on the grant date. A newly hired Executive Vice President was granted an option to buy 125,000 shares; two Senior Vice Presidents were each granted an option to buy 100,000 shares; a Vice President was granted an option to buy 50,000 shares; a Vice President was granted an option to buy 45,000 shares; eight additional non-officer…

    REDWOOD CITY, Calif., April 30, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective April 28, 2021, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 483,000 shares of the common stock of the Company to newly hired employees with a per share exercise price of $14.76, the closing trading price on the grant date. A newly hired Executive Vice President was granted an option to buy 125,000 shares; two Senior Vice Presidents were each granted an option to buy 100,000 shares; a Vice President was granted an option to buy 50,000 shares; a Vice President was granted an option to buy 45,000 shares; eight additional non-officer employees were granted options to buy an aggregate of 63,000 shares.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system. For additional information, please visit www.coherus.com.



    Coherus BioSciences Contact Information:
    
    Investor Relations:
    McDavid Stilwell, CFO
    Coherus BioSciences, Inc.
    mstilwell@coherus.com

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  19. REDWOOD CITY, Calif., April 30, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or "the Company", NASDAQ:CHRS), today announced that its first quarter 2021 financial results will be released after market close on Thursday, May 6, 2021. Starting at 4:30 p.m. ET, Coherus' management team will host a conference call and webcast to discuss financial results and provide a general business update.

    After releasing first quarter financial results, the Company will post them on the Coherus website at https://investors.coherus.com.

    Conference Call Information

    When: Thursday, May 6, 2021 starting at 4:30 p.m. ET
    Dial-in: (800) 446-2782 (Toll-Free U.S. and Canada) or (847) 413-3235 (International)
    Conference ID: 50149707
    Webcast: https://investors.coherus.com/upcoming-events

    REDWOOD CITY, Calif., April 30, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or "the Company", NASDAQ:CHRS), today announced that its first quarter 2021 financial results will be released after market close on Thursday, May 6, 2021. Starting at 4:30 p.m. ET, Coherus' management team will host a conference call and webcast to discuss financial results and provide a general business update.

    After releasing first quarter financial results, the Company will post them on the Coherus website at https://investors.coherus.com.

    Conference Call Information

    When: Thursday, May 6, 2021 starting at 4:30 p.m. ET

    Dial-in: (800) 446-2782 (Toll-Free U.S. and Canada) or (847) 413-3235 (International)

    Conference ID: 50149707

    Webcast: https://investors.coherus.com/upcoming-events

    Please dial-in 15 minutes early to ensure a timely connection to the call.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    For additional information, please visit www.coherus.com.

    Coherus BioSciences Contact Information:

    Investor Contact:

    McDavid Stilwell, CFO

    Coherus BioSciences, Inc.

    IR@coherus.com



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  20. SHANGHAI, China, and REDWOOD CITY, Calif., April 29, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that a late-breaking abstract detailing clinical data of anti-PD-1 antibody, toripalimab, in first-line treatment for recurrent or metastatic nasopharyngeal carcinoma will be featured at ASCO 2021 in the plenary session on Sunday, June 6, 2021. The abstract has also been selected for ASCO's official press program.

    Details regarding the plenary session and abstract publication are as follows:

    Title:JUPITER-02: Randomized, double-blind, phase 3 study of toripalimab or placebo plus gemcitabine and cisplatin as

    SHANGHAI, China, and REDWOOD CITY, Calif., April 29, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that a late-breaking abstract detailing clinical data of anti-PD-1 antibody, toripalimab, in first-line treatment for recurrent or metastatic nasopharyngeal carcinoma will be featured at ASCO 2021 in the plenary session on Sunday, June 6, 2021. The abstract has also been selected for ASCO's official press program.

    Details regarding the plenary session and abstract publication are as follows:

    Title:JUPITER-02: Randomized, double-blind, phase 3 study of toripalimab or placebo plus gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC)
      
    Abstract #:LBA2
      
    Presentation: Plenary session, June 6, 2021, 1:00 p.m. – 4:00 p.m. Eastern Daylight Time
      
    Publication:June 3, 2021, 5:00 p.m. Eastern Daylight Time

    "We are excited that results of JUPITER-02, a Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, have been selected for presentation during ASCO's plenary session, which traditionally features high-impact studies," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "Treatment of nasopharyngeal carcinoma, a specific type of head-and-neck cancer, is challenging, as the diagnosis usually occurs when the cancer is in an advanced stage and treatment options are limited."

    In addition to the JUPITER-02 late-breaking abstract, ASCO accepted for publication or presentation more than two dozen additional abstracts, primarily investigator-sponsored studies, that evaluate the utility of toripalimab in a variety of cancer types including lung cancer, melanoma, urothelial carcinoma, gastroesophageal cancer and hepatobiliary malignancies.

    About Toripalimab

    More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    In China, Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). On December 17, 2018, Toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April 2021, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

    In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma as well as orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) by US FDA in Feb 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    In February 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, in the United States and Canada. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma or any indication; toripalimab's possibility to be the first marketed Chinese anti-PD-1 antibody in the overseas market; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for any clinical indication; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risk that the parties are unable to obtain clearance under the Hart-Scott Rodino Antitrust Improvements Act, from the Committee on Foreign Investment in the United States, or any other statute or regulatory agency having jurisdiction with respect to the proposed transactions, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the year ended December 31, 2020 are not necessarily indicative of our operating results for any future periods.

    Junshi Biosciences Contact Information



    IR Team:

    Junshi Biosciences

    info@junshipharma.com

    + 86 021-2250 0300

    Solebury Trout

    Bob Ai

    bai@soleburytrout.com

    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li

    zhi_li@junshipharma.com

    + 86 021-6105 8800 

    Coherus BioSciences Contact Information:

    IR Contact

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    Media Contact

    Denise Powell

    denise@redhousecomms.com



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  21. REDWOOD CITY, Calif., April 23, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ:CHRS) has received notice from immuno-oncology partner Junshi Biosciences that the Independent Data Monitoring Committee of the JUPITER-06 clinical trial has determined that toripalimab, an anti-PD-1 monoclonal antibody, in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC), has achieved the pre-specified primary endpoints of progression free survival (PFS) and overall survival (OS) at the interim analysis. JUPITER-06 is a randomized, double-blind, placebo-controlled, multi-center, phase 3 clinical trial initiated in 2019 with 514 patients enrolled.

    The interim analysis…

    REDWOOD CITY, Calif., April 23, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ:CHRS) has received notice from immuno-oncology partner Junshi Biosciences that the Independent Data Monitoring Committee of the JUPITER-06 clinical trial has determined that toripalimab, an anti-PD-1 monoclonal antibody, in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC), has achieved the pre-specified primary endpoints of progression free survival (PFS) and overall survival (OS) at the interim analysis. JUPITER-06 is a randomized, double-blind, placebo-controlled, multi-center, phase 3 clinical trial initiated in 2019 with 514 patients enrolled.

    The interim analysis showed that toripalimab, in combination with paclitaxel/cisplatin, significantly prolonged the PFS and OS of patients with advanced ESCC, compared with paclitaxel/cisplatin chemotherapy alone. Data from the study are expected later this year.

    Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. More than 2,100 patients have received toripalimab treatment in clinical trials, and pivotal clinical trials are ongoing or completed evaluating toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin. In the U.S., a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

    About Esophageal Squamous Cell Carcinoma (ESCC)

    Esophageal cancer is a primary malignant tumor of the esophageal mucosa epithelium. ESCC and adenocarcinoma are the two main histological subtypes of esophageal cancer. Approximately 6,000 patients in the United States are diagnosed annually with esophageal squamous cell carcinoma. The current standard first-line treatment is platinum-based chemotherapy. The prognosis of patients with advanced ESCC is poor with five-year survival rates of less than 20%.

    About JUPITER-06 Study

    JUPITER-06 is a randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial evaluating the efficacy and safety of toripalimab combined with paclitaxel/cisplatin versus placebo combined with paclitaxel/cisplatin as first-line treatments for advanced esophageal squamous cell carcinoma. The JUPITER-06 Clinicaltrials.gov identifier is NCT03829969. Professor Ruihua Xu from the Sun Yat-sen University Cancer Hospital is the principal investigator of the JUPITER-06 study. A total of 514 patients were enrolled in the study. The primary endpoints are PFS as assessed by the Blinded Independent Review Committee and OS. Secondary endpoints include the PFS assessed by investigator, objective response rate, disease control rate and duration of response.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    In February 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, in the United States and Canada. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma or any indication; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for any clinical indication; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risk that the parties are unable to obtain clearance under the Hart-Scott Rodino Antitrust Improvements Act, from the Committee on Foreign Investment in the United States, or any other statute or regulatory agency having jurisdiction with respect to the proposed transactions, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the year ended December 31, 2020 are not necessarily indicative of our operating results for any future periods.

    Coherus BioSciences Contact Information:

    IR Contact

    McDavid Stilwell

    Coherus BioSciences, Inc.

    IR@coherus.com

    Media Contact

    Denise Powell

    denise@redhousecomms.com



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  22. REDWOOD CITY, Calif., April 20, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced the closing of the sale of Coherus common stock to Junshi Biosciences. Under the terms of the February 2, 2021 stock purchase agreement, Coherus has received $50 million from Junshi Biosciences' acquisition of 2,491,988 shares at a price per share of $20.06. The collaboration agreement between the companies for the development and commercialization in the United States and Canada of toripalimab, Junshi Biosciences' PD-1 antibody, became effective in March.

    "This collaboration is a tremendous opportunity for Junshi Biosciences given Coherus' commercial expertise and track record in bringing affordable high-quality medicines…

    REDWOOD CITY, Calif., April 20, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced the closing of the sale of Coherus common stock to Junshi Biosciences. Under the terms of the February 2, 2021 stock purchase agreement, Coherus has received $50 million from Junshi Biosciences' acquisition of 2,491,988 shares at a price per share of $20.06. The collaboration agreement between the companies for the development and commercialization in the United States and Canada of toripalimab, Junshi Biosciences' PD-1 antibody, became effective in March.

    "This collaboration is a tremendous opportunity for Junshi Biosciences given Coherus' commercial expertise and track record in bringing affordable high-quality medicines to patients," said Dr. Ning LI, CEO of Junshi Biosciences. "Since the collaboration was announced two months ago, we have already made progress toward the introduction of toripalimab in the United States with the initiation of the rolling submission of the Biologics License Application (BLA) for treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)."

    "It is an honor to welcome Junshi Biosciences as both collaborators and investors as we build on our oncology biosimilar success with the expansion of our mission into immuno-oncology. This investment speaks volumes about Junshi Biosciences' commitment to our partnership," said Denny Lanfear, Chief Executive Officer of Coherus. "Our teams are already making excellent progress with the NPC BLA submission and are working together closely on the registration strategy for additional toripalimab indications."

    About the Exclusive License and Commercialization Agreement

    Under the terms of the collaboration agreement, Coherus paid $150 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences' anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. Coherus will also pay Junshi Biosciences a 20% royalty on net sales of toripalimab and up to an aggregate $380 million in one-time payments for the achievement of various milestones. The option exercise fee for each of the anti-TIGIT antibody and the IL-2 cytokine is $35 million per program. Additionally, for each option program, Coherus will pay Junshi Biosciences an 18% royalty on net sales and up to an aggregate $255 million for the achievement of various milestones. The Companies will collaborate in the development of toripalimab and other licensed compounds, and Coherus will pay for a portion of these co-development activities up to a maximum of $25 million per licensed compound per year.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) by US FDA in Feb 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    In February 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, in the United States and Canada. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma or any indication; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA for any clinical indication; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risk that the parties are unable to obtain clearance under the Hart-Scott Rodino Antitrust Improvements Act, from the Committee on Foreign Investment in the United States, or any other statute or regulatory agency having jurisdiction with respect to the proposed transactions, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the year ended December 31, 2020 are not necessarily indicative of our operating results for any future periods.

    Coherus BioSciences Contact Information:

    IR Contact

    McDavid Stilwell

    Coherus BioSciences, Inc.

    IR@coherus.com

    Media Contact

    Denise Powell

    denise@redhousecomms.com



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  23. Blade Therapeutics, Inc. (Blade or the Company), a biopharmaceutical company committed to revolutionizing the treatment of fibrotic diseases, today announced the appointment of Jean-Frédéric Viret, Ph.D., as Chief Financial Officer (CFO) effective immediately. In his role, Dr. Viret will lead Blade's finance and accounting functions, as well as investor relations and corporate communications.

    "Jean's broad corporate finance experience and track record of building substantial value for companies will be critical as Blade continues to advance its pipeline of innovative therapies," said Wendye Robbins, M.D., President and Chief Executive Officer of Blade. "I am delighted to welcome Jean to our team."

    Dr. Viret has nearly two decades of corporate…

    Blade Therapeutics, Inc. (Blade or the Company), a biopharmaceutical company committed to revolutionizing the treatment of fibrotic diseases, today announced the appointment of Jean-Frédéric Viret, Ph.D., as Chief Financial Officer (CFO) effective immediately. In his role, Dr. Viret will lead Blade's finance and accounting functions, as well as investor relations and corporate communications.

    "Jean's broad corporate finance experience and track record of building substantial value for companies will be critical as Blade continues to advance its pipeline of innovative therapies," said Wendye Robbins, M.D., President and Chief Executive Officer of Blade. "I am delighted to welcome Jean to our team."

    Dr. Viret has nearly two decades of corporate finance experience within the life sciences industry, most recently serving as CFO with Coherus BioSciences, Inc. (NASDAQ:CHRS), a commercial-stage biopharmaceutical company that he joined in 2014. He has previous experience in CFO roles during tenures at several public and privately held biopharmaceutical and diagnostics companies. In addition to a Ph.D. in Plant Molecular Biology from Université Louis Pasteur (Strasbourg), Dr. Viret has a B.S. in Engineering from the Institut National Polytechnique de Lorraine and an M.B.A. from Cornell University. He was a visiting fellow at Harvard University and a postdoctoral fellow at the Massachusetts Institute of Technology.

    "I am excited to join the team at Blade and work with them to bring forward innovative therapies with the potential to transform positively the lives of patients who suffer from fibrotic and neurodegenerative diseases," said Dr. Viret.

    About Blade Therapeutics

    Blade Therapeutics is a private biopharmaceutical company founded on a commitment to revolutionize the treatment of debilitating, incurable fibrotic diseases that impact millions of people worldwide. The Company is an expert in novel biological pathways – including autotaxin / lysophosphatidic acid (LPA) and calpain biology – that are foundational to cell and tissue damage responses leading to fibrosis. Blade is advancing a robust pipeline of potential first-in-class investigational therapies for diseases of lung, liver and heart fibrosis, as well as neurodegenerative diseases. This includes multiple small-molecule direct inhibitors of autotaxin / LPA and dimeric calpains that offer distinct but complementary anti-fibrotic mechanisms.

    Since its founding in 2015, Blade has raised approximately $90 million, including investments from Deerfield Management, MPM Capital, Pfizer Ventures, One Ventures, Osage University Partners, Bay City Capital and pharma strategic investments from Bristol-Myers Squibb and Novartis Institutes for Biomedical Research. The Company has assembled critical leadership expertise supplemented by a world-class network of scientific, pharmaceutical and clinical advisors to enable efficient and successful drug development. Visit www.blademed.com for more information and follow us on LinkedIn.

    About Fibrosis

    Fibrosis is a complex, pathologic process involving the development of fibrous connective tissue (scarring) within various organs. The process of fibrosis is triggered by an injury that damages cells or tissues in the epithelium. Once present, normal cellular function is impeded. Later-stage fibrotic disease is marked by poor outcomes and high morbidity and mortality. Diseases characterized by uncontrolled, progressive fibrosis include idiopathic pulmonary fibrosis (IPF), non-alcoholic steatohepatitis (NASH) and interstitial lung disease (ILD). New safe, well-tolerated therapies that provide robust attenuation of disease progression are needed to address the high burden of fibrotic diseases, as well as neurodegenerative disease.

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  24. - BLA submitted with FDA's breakthrough therapy designation –

    SHANGHAI, China, and REDWOOD CITY, Calif., March 03, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (("Coherus", NASDAQ:CHRS) announced today the initiation of the rolling submission of the Biologics License Application ("BLA") for toripalimab to the U.S. Food and Drug Administration ("FDA") for the treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC"). A rolling submission allows Junshi Biosciences to submit sections of the BLA to the FDA as they are completed.

    Toripalimab has been granted Breakthrough Therapy Designation by the FDA for the treatment of recurrent or metastatic…

    - BLA submitted with FDA's breakthrough therapy designation –

    SHANGHAI, China, and REDWOOD CITY, Calif., March 03, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (("Coherus", NASDAQ:CHRS) announced today the initiation of the rolling submission of the Biologics License Application ("BLA") for toripalimab to the U.S. Food and Drug Administration ("FDA") for the treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC"). A rolling submission allows Junshi Biosciences to submit sections of the BLA to the FDA as they are completed.

    Toripalimab has been granted Breakthrough Therapy Designation by the FDA for the treatment of recurrent or metastatic nasopharyngeal carcinoma based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies. The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. Toripalimab is the first anti-PD-1 monoclonal antibody developed in China with a BLA submission to the FDA in process.

    In February 2021, Junshi Biosciences and Coherus entered into a collaboration for the development and commercialization of toripalimab in the United States and Canada. Coherus will be responsible for all commercial activities in the licensed territory. Closing of the collaboration agreement is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act, which is expected later this month.

    "There has been limited development of treatment approaches for patients with advanced NPC in the U.S.," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We are determined to advance effective treatments in the U.S. by leveraging the successful experience with toripalimab, a safe and effective treatment for previously treated NPC that is now approved for marketing in China. We appreciate the FDA's recognition of this potentially important new treatment through its Breakthrough Therapy Designation, which enables the acceleration of the review process. We will work closely with the FDA to facilitate the review of the U.S. marketing application in order to make toripalimab available for patients in the U.S. as soon as possible."

    "Toripalimab could address a significant unmet medical need as a new treatment for advanced NPC, and we are encouraged by the initiation of the BLA submission," said Denny Lanfear, CEO of Coherus. "With an extensive clinical development program across a range of tumor types, a broad therapeutic profile is developing for toripalimab. We look forward to working with Junshi Biosciences to bring this new anti-PD-1 antibody to patients in the U.S. and Canada."

    Following potential approval of toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma, and assuming successful closing of their collaboration agreement, Coherus and Junshi Biosciences plan to file additional toripalimab BLA supplements with the FDA over the next three years for multiple rare cancers as well as highly prevalent cancers, including non-small cell lung cancer ("NSCLC").

    About Toripalimab

    Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The supplemental NDA of Toripalimab for the second-line treatment of metastatic urothelial carcinoma was accepted by the NMPA in May 2020 and received priority review designation from the NMPA in July 2020. In September 2020, Toripalimab was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Currently, Toripalimab has been granted 1 Breakthrough, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China's first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) by US FDA in Feb 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    In February 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, in the United States and Canada. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma or any indication; toripalimab's possibility to be the first marketed Chinese anti-PD-1 antibody in the overseas market; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for any clinical indication; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risk that the parties are unable to obtain clearance under the Hart-Scott Rodino Antitrust Improvements Act, from the Committee on Foreign Investment in the United States, or any other statute or regulatory agency having jurisdiction with respect to the proposed transactions, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the year ended December 31, 2020 are not necessarily indicative of our operating results for any future periods.

    Junshi Biosciences Contact Information



    IR Team:

    Junshi Biosciences

    info@junshipharma.com

    + 86 021-2250 0300

    Solebury Trout

    Bob Ai

    bai@soleburytrout.com

    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li

    zhi_li@junshipharma.com

    + 86 021-6105 8800 

    Coherus BioSciences Contact Information:

    IR Contact

    McDavid Stilwell

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    Media Contact

    Denise Powell

    denise@redhousecomms.com



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  25. REDWOOD CITY, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), announced today that senior management will present at the following investor conferences in March.

    • 41st Annual Cowen Healthcare Conference on Monday, March 1 at 4 p.m. ET
    • Barclays Global Healthcare Conference on Tuesday, March 9 at 1:15 p.m. ET

    The audio portion of the presentation will be available on the investors' page of the Coherus BioSciences website at http://investors.coherus.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care…

    REDWOOD CITY, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), announced today that senior management will present at the following investor conferences in March.

    • 41st Annual Cowen Healthcare Conference on Monday, March 1 at 4 p.m. ET
    • Barclays Global Healthcare Conference on Tuesday, March 9 at 1:15 p.m. ET

    The audio portion of the presentation will be available on the investors' page of the Coherus BioSciences website at http://investors.coherus.com.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    For additional information, please visit www.coherus.com.

    Contact

    McDavid Stilwell

    EVP, Financial Strategy and IR

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152

     



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  26. - Product revenues of $476 million for full year 2020, $110 million for the fourth quarter of 2020 - 
    - Expanding late-stage opportunities with Junshi Biosciences immuno-oncology collaboration with first BLA filing expected this year - 
    - Pipeline progress with CHS-1420 (adalimumab biosimilar) BLA accepted by FDA and FYB201 (ranibizumab biosimilar) BLA on track for mid-year filing - 
    - Conference call and webcast today at 4:30 p.m. ET -

    REDWOOD CITY, Calif., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today reviewed recent corporate events and reported financial results for the quarter and full year ended December 31, 2020.

    UDENYCA® (pegfilgrastim-cbqv) delivered strong results in

    - Product revenues of $476 million for full year 2020, $110 million for the fourth quarter of 2020 - 

    - Expanding late-stage opportunities with Junshi Biosciences immuno-oncology collaboration with first BLA filing expected this year - 

    - Pipeline progress with CHS-1420 (adalimumab biosimilar) BLA accepted by FDA and FYB201 (ranibizumab biosimilar) BLA on track for mid-year filing - 

    - Conference call and webcast today at 4:30 p.m. ET -

    REDWOOD CITY, Calif., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today reviewed recent corporate events and reported financial results for the quarter and full year ended December 31, 2020.

    UDENYCA® (pegfilgrastim-cbqv) delivered strong results in 2020:

    • $476 million in net sales for the full year; $110 million for the fourth quarter.
    • With excellent commercial execution in the face of COVID-19 headwinds, maintained position as leading pegfilgrastim biosimilar in the United States with 21% share of the overall pegfilgrastim market and nearly 50% share of the pre-filled syringe segment.

    Financial strength to execute on our immuno-oncology and biosimilar pipeline and commercial plans:

    • Cash flow from operating activities was $154 million for 2020 and $33 million for the fourth quarter of 2020.
    • Coherus had cash and cash equivalents of $541 million at December 31, 2020.
    • Net income was $132 million for 2020, or $1.62 per share on a diluted basis, and for the fourth quarter of 2020 was $10 million, or $0.12 per share on a diluted basis.

    "We are very pleased with the strong performance of UDENYCA® in the face of challenging COVID-19 conditions in 2020 and with the recent progress of our biosimilar pipeline candidates," said Denny Lanfear, Chief Executive Officer of Coherus. "With our recently announced collaboration with Junshi Biosciences, we are building a focused immuno-oncology franchise atop the strong foundation of UDENYCA® and our late-stage Lucentis®, Avastin® and Humira® biosimilar candidates. As our commercial biosimilar portfolio expands, we expect to generate strong cash flows to leverage into commercialization of toripalimab, if approved, as well as development of PD-1 combination therapies to drive longer-term growth."

    Pipeline Progress and Recent Corporate Highlights

    • Immuno-oncology collaboration with Junshi Biosciences: In February, Coherus announced a collaboration with Junshi Biosciences for the development and commercialization of Junshi Biosciences' anti-PD-1 antibody, toripalimab, in the United States and Canada. Upon satisfaction of closing conditions, which is expected to occur in the first quarter 2021, Coherus and Junshi Biosciences will co-develop toripalimab, and Coherus will be responsible for all commercial activities in the United States and Canada.
      • The U.S. Food and Drug Administration ("FDA") has granted breakthrough therapy designation to toripalimab for third-line nasopharyngeal carcinoma ("NPC"), and Coherus expects the first toripalimab biologics license application ("BLA") to be filed with the FDA for this indication in 2021. On February 20, 2021, Junshi Biosciences announced the approval in China of toripalimab for the treatment of patients with recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy.
      • 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").



    • FYB201, a biosimilar Lucentis® (ranibizumab) product candidate in collaboration with Bioeq AG: Bioeq expects to file the FYB201 BLA mid-year 2021 following a supportive pre-BLA meeting with the FDA earlier in the first quarter of 2021. Bioeq reviewed new manufacturing data with the FDA which the agency requested last year, as well as other elements of the BLA filing.



    • CHS-1420, a wholly owned biosimilar Humira® (adalimumab) product candidate: The FDA accepted for review the BLA for CHS-1420 and assigned a target action date in December 2021. Coherus plans to launch CHS-1420 on or after July 1, 2023, if approved.



    • IBI-305, a biosimilar Avastin® (bevacizumab) product candidate in collaboration with Innovent Biologics (Suzhou) Co. Ltd: Earlier in the first quarter of 2021, Coherus initiated the three-way pharmacokinetic study required prior to potential BLA submission later this year.

    Fourth Quarter and Full Year 2020 Financial Results

    Net product revenue, consisting of net sales of UDENYCA®, was $110.4 million for the fourth quarter of 2020 compared to $123.9 million for the same period in 2019. The decline was primarily due to an increase in discounts and allowances incurred, which was partially offset by an increase in the number of units of UDENYCA® sold. Net product revenue for 2020 was $475.8 million compared to $356.1 million for 2019, an increase of $119.7 million. The increase was primarily due to an increase in the number of units of UDENYCA® sold, which was partially offset by an increase in discounts and allowances incurred during the year ended December 31, 2020.

    Research and development (R&D) expenses for the fourth quarter of 2020 were $44.6 million, compared to $34.9 million for the same period in 2019. The increase was mainly due to increased clinical development activities as well as payments for certain negotiation rights for pipeline development. R&D expense for 2020 was $142.8 million compared to $94.2 million for 2019, an increase of $48.6 million. The increase was primarily due to costs incurred in support of the BLA submission for CHS-1420 and for development activities related to other biosimilar product candidates.

    Selling, general and administrative (SG&A) expenses were relatively unchanged quarter-over-quarter and year-over-year. SG&A expenses for the fourth quarter of 2020 were $37.7 million, compared to $36.1 million for the same period in 2019. SG&A expenses for 2020 were $139.1 million, compared to $137.0 million for 2019.

    Cash and cash equivalents were $541.2 million as of December 31, 2020, compared to $177.7 million as of December 31, 2019. During 2020, Coherus generated $154.1 million in operating cash flow, used $14.4 million in investing activities, including $7.5 million in upfront and milestone payments to collaborators, and received net cash proceeds of $223.9 million from financing activities related to the issuance of convertible notes due in 2026, less issuance costs and the purchase of related capped call options, as well as proceeds from the exercise of stock options and from purchases under the stock purchase plan.

    Net income for the fourth quarter of 2020 was $9.7 million, or $0.12 per share on a diluted basis, compared to a net income of $39.2 million, or $0.53 per share on a diluted basis for the same period in 2019. Net income for 2020 was $132.2 million, or $1.62 per share on a diluted basis, compared to a net income of $89.8 million, or $1.23 per share on a diluted basis for 2019.

    Non-GAAP net income for the fourth quarter of 2020 was $18.6 million, or $0.23 per share on a diluted basis, compared to non-GAAP income of $56.7 million, or $0.75 per share on a diluted basis for the same period in 2019. Non-GAAP net income for 2020 was $176.7 million, or $2.16 per share on a diluted basis, compared to non-GAAP income of $133.1 million, or $1.82 per share on a diluted basis for 2019. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measures.

    2021 Guidance

    Coherus projects lower UDENYCA® net sales revenue in 2021 compared to 2020. Starting from a seasonally low first quarter impacted by customer buying patterns and COVID-19, Coherus expects UDENYCA® revenue and market share to rise over the remainder of the year, assuming treatment patterns normalize as the general population is vaccinated against COVID-19.

    Excluding upfront, milestone and development expenses related to the recently announced collaboration with Junshi Biosciences, which is expected to close in the first quarter of 2021, Coherus projects R&D and SG&A expenses combined will increase in 2021 to a range of $310 million to $350 million, with external R&D spending focused on manufacturing-related activities in preparation for the potential launch of CHS-1420, if approved, and development activities for IBI-305 and for additional presentations of UDENYCA®.

    This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

    Conference Call Information

    When: Wednesday, February 24, 2021 starting at 4:30 p.m. ET

    Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

    Conference ID: 3770488

    Webcast: https://investors.coherus.com/upcoming-events 

    Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

    Fourth quarter and full year 2019 financial results are posted on the Coherus website at https://investors.coherus.com/

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    For additional information, please visit www.coherus.com.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to maintain UDENYCA® market share and position as leading pegfilgrastim biosimilar in the United States.; Coherus' ability to generate increased revenue from its UDENYCA business® with anticipated market share growth, assuming treatment patterns begin to normalize as the general population is vaccinated against COVID-19; Coherus' ability to expand its addressable market opportunity and to lay the foundation for long-term growth across its biosimilar product portfolio and immuno-oncology product pipeline; Coherus' ability to advance the Company's oncology biosimilar candidate to Avastin® (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, depending on the outcome of the three-way PK study, the timing of required interactions with the FDA; Coherus' ability to launch Innovent's biosimilar candidate to Avastin® in the United States; Coherus' ability to facilitate Bioeq's resubmission of a BLA with the FDA for the ophthalmology biosimilar candidate to Lucentis® (ranibizumab) in mid-2021 and Coherus' ability to launch the product, if approved; Coherus' ability to facilitate Junshi Biosciences' submission of a toripalimab BLA with the FDA for nasopharyngeal carcinoma in 2021 and for additional indications, including lung cancer, over the next three years; the timing of the FDA's approval decision for CHS-1420, a Humira® (adalimumab) biosimilar, and the risk that the product may not be approved on time, if at all; Coherus' ability to continue other CHS-1420 activities to advance toward a projected market entry in the United States on or after July 1, 2023; and Coherus' ability to meet its R&D and SG&A expenses guidance for the full fiscal year 2021. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' biosimilar drug candidates; the risk that Coherus and Junshi Bioscience are unable to obtain regulatory clearance to close the collaboration; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020, filed with the Securities and Exchange Commission on November 5, 2020 and its future periodic reports to be filed with the Securities and Exchange Commission, including Coherus' Annual Report on Form 10-K for the year ended December 31, 2020, which the Company expects to file on February 25, 2021. Our results for the quarter and fiscal year ended December 31, 2020 are not necessarily indicative of our operating results for any future periods.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Neulasta® and Onpro® are registered trademarks of Amgen Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Coherus BioSciences, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

    (unaudited)

      Three Months Ended Year Ended
      December 31, December 31,
      2020  2019  2020  2019 
    Revenue:            
    Net product revenue $110,419  $123,856  $475,824  $356,071 
    Operating expenses:            
    Cost of goods sold  11,673   7,805   37,667   17,078 
    Research and development  44,628   34,948   142,759   94,188 
    Selling, general and administrative  37,693   36,070   139,079   137,037 
    Total operating expenses  93,994   78,823   319,505   248,303 
    Income from operations  16,425   45,033   156,319   107,768 
    Interest expense  (5,671)  (4,483)  (21,166)  (17,601)
    Other income, net  6   721   554   2,608 
    Net income before income taxes  10,760   41,271   135,707   92,775 
    Income tax provision  1,052   2,044   3,463   2,942 
    Net income $9,708  $39,227  $132,244  $89,833 
                 
    Net income per share:            
    Basic $0.13  $0.56  $1.85  $1.29 
    Diluted $0.12  $0.53  $1.62  $1.23 
                 
    Weighted-average number of shares used in computing net income per share:            
    Basic  72,223,970   70,208,351   71,411,705   69,679,916 
    Diluted  87,713,218   78,360,388   83,491,898   73,185,943 

    Coherus BioSciences, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

            
         December 31,    December 31, 
      2020 2019 
    Assets       
    Cash and cash equivalents $541,158 $177,668 
    Trade receivables, net  157,046  141,992 
    Inventory  92,189  55,071 
    Other assets  51,256  34,196 
    Total assets $841,649 $408,927 
    Liabilities and Stockholders' Equity       
    Accrued rebates, fees and reserve $81,529 $51,120 
    Convertible notes due 2022  79,885  78,542 
    Convertible notes due 2022 - related parties  26,628  26,181 
    Convertible notes due 2026  223,029   
    Term loan  74,481  73,663 
    Other liabilities  75,123  74,207 
    Total stockholders' equity  280,974  105,214 
    Total liabilities and stockholders' equity $841,649 $408,927 
            

    Coherus BioSciences, Inc.

    Condensed Consolidated Cash Flow

    (in thousands)

    (unaudited)

      Three Months Ended Year Ended
      December 31, December 31,
      2020  2019  2020  2019 
    Cash, cash equivalents and restricted cash at beginning of the period    $292,905     $165,166     $177,908     $73,191 
                 
    Net cash provided by operating activities $33,124  $17,710  $154,145  $28,355 
                 
    Purchases of investments in marketable securities        (273,845)  (20,235)
    Proceeds from maturities of investments in marketable securities  211,000   5,400   274,000   20,400 
    Upfront and milestone based license fee payments     (11,075)  (7,500)  (11,075)
    Purchases of property and equipment and other investing activities  (944)  (387)  (7,056)  (1,822)
    Net cash provided by (used in) investing activities $210,056  $(6,062) $(14,401) $(12,732)
                 
    Proceeds related to issuance of Convertible Notes due 2026, net of issuance costs        222,156    
    Purchase of capped call options related to convertible notes due 2026        (18,170)   
    Proceeds related to the term loan, net of issuance costs           72,955 
    Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs           8,153 
    Proceeds from issuance of common stock upon exercise of stock options  4,414   374   17,428   5,558 
    Proceeds from purchase under the employee stock purchase plan  1,243   1,641   3,800   3,519 
    Principal payments for finance lease obligations and other financing activities  (144)  (815)  (1,268)  (815)
    Net cash provided by financing activities $5,513  $1,200  $223,946  $89,370 
                 
    Effect of exchange rate changes on cash     (106)     (276)
                 
    Net increase in cash, cash equivalents and restricted cash $248,693  $12,742  $363,690  $104,717 
                 
    Cash, cash equivalents and restricted cash at end of the period $541,598  $177,908  $541,598  $177,908 
                 
    Reconciliation of cash, cash equivalents, and restricted cash            
    Cash and cash equivalents $541,158  $177,668  $541,158  $177,668 
    Restricted cash – non-current  440   240   440   240 
    Cash, cash equivalents and restricted cash $541,598  $177,908  $541,598  $177,908 

    Non-GAAP Financial Measures

    To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net income, and the related per share measures, which exclude from net income, and the related per share measures, stock-based compensation expense, upfront and milestone payments under the license agreements and the related income tax effect of those non-GAAP adjustments. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus' business.

    Coherus believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare Coherus' results from period to period, and to identify operating trends in Coherus' business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.

    Coherus BioSciences, Inc.

    Reconciliation of GAAP Net Income to Non-GAAP Net Income

    (in thousands, except share and per share data)

    (unaudited)

                 
      Three Months Ended Year Ended
      December 31, December 31,
      2020  2019  2020  2019 
    GAAP net income $9,708  $39,227  $132,244  $89,833 
    Adjustments:            
    Stock based compensation expense  9,873   7,272   38,160   33,591 
    Upfront and milestone based license fee payments     11,075   7,500   11,075 
    Income tax effect of the above adjustments  (965)  (909)  (1,165)  (1,416)
    Non-GAAP net income $18,616  $56,665  $176,739  $133,083 
                 
    GAAP net income per share, basic $0.13  $0.56  $1.85  $1.29 
    GAAP net income per share, diluted $0.12  $0.53  $1.62  $1.23 
    Non-GAAP net income per share, basic $0.26  $0.81  $2.47  $1.91 
    Non-GAAP net income per share, diluted $0.23  $0.75  $2.16  $1.82 

    Contact

    McDavid Stilwell

    EVP, Financial Strategy and IR

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152



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  27. REDWOOD CITY, Calif., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or "the Company", NASDAQ:CHRS), today announced that it will release fourth quarter and full year 2020 financial results after the market closes on Wednesday, February 24, 2021. The news release will be followed by an investor conference call at 4:30 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

    Conference Call Information

    When: Wednesday, February 24, 2021 starting at 4:30 p.m. ET
    Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
    Conference ID: 3770488
    Webcast: https://investors.coherus.com/upcoming-events

    REDWOOD CITY, Calif., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or "the Company", NASDAQ:CHRS), today announced that it will release fourth quarter and full year 2020 financial results after the market closes on Wednesday, February 24, 2021. The news release will be followed by an investor conference call at 4:30 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

    Conference Call Information

    When: Wednesday, February 24, 2021 starting at 4:30 p.m. ET

    Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

    Conference ID: 3770488

    Webcast: https://investors.coherus.com/upcoming-events

    Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    For additional information, please visit www.coherus.com.

    Contact

    McDavid Stilwell

    EVP, Financial Strategy and IR

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152



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  28. REDWOOD CITY, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: "CHRS", "the Company", "Coherus") announced that the United States Food and Drug Administration ("FDA") has accepted for review the 351(k) Biologics License Application ("BLA") for CHS-1420, a Humira® (adalimumab) biosimilar product candidate, and has set a Biosimilar User Fee Act action date for December 2021. If approved, Coherus plans to launch the adalimumab biosimilar in the U.S. on or after July 1, 2023, per the terms of an agreement with Humira® manufacturer AbbVie.

    "We are pleased to see the CHS-1420 BLA accepted for review as we continue to execute on our mission to increase patient access to important medicines and deliver substantial savings…

    REDWOOD CITY, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: "CHRS", "the Company", "Coherus") announced that the United States Food and Drug Administration ("FDA") has accepted for review the 351(k) Biologics License Application ("BLA") for CHS-1420, a Humira® (adalimumab) biosimilar product candidate, and has set a Biosimilar User Fee Act action date for December 2021. If approved, Coherus plans to launch the adalimumab biosimilar in the U.S. on or after July 1, 2023, per the terms of an agreement with Humira® manufacturer AbbVie.

    "We are pleased to see the CHS-1420 BLA accepted for review as we continue to execute on our mission to increase patient access to important medicines and deliver substantial savings to the healthcare system," said Denny Lanfear, CEO of Coherus. "Our market research indicates that there is substantial pent-up demand for biosimilars of Humira®. With annual U.S. Humira® sales projected to exceed $18 billion by the time of our planned launch, the adalimumab market is by far the largest opportunity in our biosimilar pipeline. We plan to be a top competitor and expect to earn significant sales of CHS-1420, growing and diversifying the biosimilar portfolio revenues funding our expansion into immuno-oncology."

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    In February 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, in the United States and Canada. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    For additional information, please visit www.coherus.com.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' expectations regarding the timing of the filing of the BLA for CHS-1420 and approvability of CHS-1420; Coherus' expectations regarding the timing of the U.S. commercial launch of CHS-1420, and its ability to use and leverage its commercial infrastructure for such commercial launch; Coherus' expectation to continue the development of its biosimilars in anti-inflammatory and ophthalmology therapeutic areas; Coherus' expectation that it will garner significant share and earn significant sales revenue in the adalimumab market; Coherus' expectations regarding the value to patients of Coherus' products in development; and Coherus' ability to reduce costs to patients and provide significant savings to the healthcare system; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved; Coherus' expectations regarding the value to patients of Coherus' products in development; and Coherus' ability to reduce costs to patients and provide significant savings to the healthcare system.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of review of Coherus' regulatory filings such as the biologics license application for CHS-1420; the risk that CHS-1420 will not be approved prior to the anticipated U.S. market launch on or after July 1, 2023; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 27, 2020, its Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020, filed with the Securities and Exchange Commission on November 5, 2020 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended September 30, 2020 are not necessarily indicative of our operating results for any future periods.

    Contact

    McDavid Stilwell

    EVP, Financial Strategy and IR

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152



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  29. REDWOOD CITY, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: "CHRS", "the Company", "Coherus") announced that Chief Financial Officer Jean-Frédéric Viret, Ph.D. will resign from Coherus effective March 7, 2021 to pursue another opportunity. McDavid Stilwell has been appointed to succeed Dr. Viret as CFO.

    "It has been a sincere pleasure working with Jean over more than six years as we have built Coherus into a growing commercial-stage biotech company. He will always be a part of the Coherus family. I thank him for his contributions and wish him every success in his future endeavors," said Denny Lanfear, CEO of Coherus. "I am excited to welcome McDavid to the CFO role at Coherus. With his years of finance, corporate…

    REDWOOD CITY, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: "CHRS", "the Company", "Coherus") announced that Chief Financial Officer Jean-Frédéric Viret, Ph.D. will resign from Coherus effective March 7, 2021 to pursue another opportunity. McDavid Stilwell has been appointed to succeed Dr. Viret as CFO.

    "It has been a sincere pleasure working with Jean over more than six years as we have built Coherus into a growing commercial-stage biotech company. He will always be a part of the Coherus family. I thank him for his contributions and wish him every success in his future endeavors," said Denny Lanfear, CEO of Coherus. "I am excited to welcome McDavid to the CFO role at Coherus. With his years of finance, corporate strategy, and investor relations experience, I believe he will have a significant positive impact as we turn our strategic focus to immuno-oncology and our pipeline programs progress through key clinical, regulatory and commercial milestones."

    Mr. Stilwell joined Coherus in 2020 and brings over 25 years of experience in finance, corporate development, investor relations and communications. Previously, he was Senior Vice President, Communications and Investor Relations at Sangamo Therapeutics. Prior to joining Sangamo, Mr. Stilwell served as Vice President, Corporate Communications, Investor Relations & Business Development at Orexigen Therapeutics, and, from 2005 to 2012, as Director, Business Development, Corporate Communications and Financial Analysis at GTx. Earlier in his career, Mr. Stilwell worked for five years as Senior Investment Analyst at Shadwell Capital, a hedge fund. Mr. Stilwell began his career as a journalist, first as a newspaper reporter and later as editor of an investor newsletter covering the financial services industry. Mr. Stilwell received a B.A. from St. John's College and a M.B.A. from Harvard Business School.

    "I am honored to step into the CFO role at this unique juncture in Coherus' evolution," said Mr. Stilwell. "I look forward to helping the Company achieve its strategic and financial objectives and fulfill its mission to increase patient access to medicines that can have a major impact on their lives while also delivering significant savings to the health care system."

    About Coherus BioSciences

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    In February 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, in the United States and Canada. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    For additional information, please visit www.coherus.com.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' expectations regarding its ability to generate cash flow from its commercial biosimilars business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' expectations regarding the value to patients of Coherus' products in development; Coherus' ability to reduce costs to patients and provide significant savings to the healthcare system; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Avastin®, Humira® and Lucentis®, if approved; Coherus' expectations regarding the value to patients of Coherus' products in development; and Coherus' ability to reduce costs to patients and provide significant savings to the healthcare system.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of review of Coherus' regulatory filings such as the biologics license application for CHS-1420; the risk that CHS-1420 will not be approved prior to the anticipated U.S. market launch on or after July 1, 2023; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 27, 2020, its Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020, filed with the Securities and Exchange Commission on November 5, 2020 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended September 30, 2020 are not necessarily indicative of our operating results for any future periods.

    Contact

    McDavid Stilwell

    EVP, Financial Strategy and IR

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152



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  30. REDWOOD CITY, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) -- A day after announcing their new immuno-oncology collaboration, Coherus BioSciences, Inc. (NASDAQ:CHRS) ("Coherus") announced that Shanghai Junshi Biosciences Co., Ltd (HK: 1877; SH: 688180) ("Junshi Biosciences") intends to make a strategic investment of $50 million in Coherus pursuant to the terms of the definitive stock purchase agreement.  

    "We view our collaboration with Coherus as a strategic long-term partnership for the development and commercialization of toripalimab and promising PD-1 combination candidates," said Dr. Ning LI, CEO of Junshi Biosciences. "We wanted to invest in Coherus so we could share our future growth together and mutual success with these programs."  

    "We…

    REDWOOD CITY, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) -- A day after announcing their new immuno-oncology collaboration, Coherus BioSciences, Inc. (NASDAQ:CHRS) ("Coherus") announced that Shanghai Junshi Biosciences Co., Ltd (HK: 1877; SH: 688180) ("Junshi Biosciences") intends to make a strategic investment of $50 million in Coherus pursuant to the terms of the definitive stock purchase agreement.  

    "We view our collaboration with Coherus as a strategic long-term partnership for the development and commercialization of toripalimab and promising PD-1 combination candidates," said Dr. Ning LI, CEO of Junshi Biosciences. "We wanted to invest in Coherus so we could share our future growth together and mutual success with these programs."  

    "We appreciate this vote of confidence and commitment in Coherus, and we are pleased to have Junshi Biosciences as a partner and now also as a shareholder," said Denny Lanfear, CEO of Coherus.  

    Closing of the strategic investment is subject to obtaining requisite market and securities authorities approvals and to clearance under the Hart-Scott Rodino Antitrust Improvements Act.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising 27 innovative drug candidates and two biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA, and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China's first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now a part of the company's continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences, Inc.

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    On February 1, 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, in the United States and Canada. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risk that the parties are unable to obtain clearance under the Hart-Scott Rodino Antitrust Improvements Act, from the Committee on Foreign Investment in the United States, or any other statute or regulatory agency having jurisdiction with respect to the proposed transactions, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 27, 2020, its Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020, filed with the Securities and Exchange Commission on November 5, 2020 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended September 30, 2020 are not necessarily indicative of our operating results for any future periods.

    Contact

    McDavid Stilwell

    EVP, Financial Strategy and IR

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152



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    • Junshi Biosciences to receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised) in US and Canada
    • The first toripalimab BLA to be filed with the US FDA for nasopharyngeal carcinoma later this year

    SHANGHAI, China, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, today announced a collaboration with Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) for the development and commercialization of toripalimab, Junshi Biosciences' anti-PD-1 antibody…

    • Junshi Biosciences to receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised) in US and Canada

    • The first toripalimab BLA to be filed with the US FDA for nasopharyngeal carcinoma later this year

    SHANGHAI, China, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, today announced a collaboration with Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) for the development and commercialization of toripalimab, Junshi Biosciences' anti-PD-1 antibody, in the United States and Canada.

    Under the terms of the agreement, Junshi Biosciences will receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised). Junshi Biosciences and Coherus will co-develop toripalimab, and Coherus will be responsible for all commercial activities in US and Canada. Junshi Biosciences has also granted Coherus options to JS006 (an anti-TIGIT antibody) and JS018-1 (a next generation engineered IL-2 cytokine), as well as first negotiation rights to two early-stage checkpoint inhibitor antibodies.

    "We believe Coherus is the ideal partner for us in North America. Their commercial team has demonstrated remarkable ability to gain significant share of the oncology market against entrenched large competitors," said Dr. Ning LI, CEO of Junshi Biosciences. "Toripalimab could be the first marketed Chinese anti-PD-1 antibody in the overseas market. The collaboration with Coherus will be a critical step to build up our global commercial network. We look forward to working closely with Coherus to establish toripalimab's position in the United States and Canadian markets in order to provide patients with affordable high-quality innovative care."

    "Toripalimab has a compelling clinical profile with impressive efficacy and safety, and we are thrilled to collaborate with Junshi Biosciences to deliver patient benefit in the United States and Canada," said Denny Lanfear, CEO of Coherus. "Our mission has always been to increase patient access to important medicines and to deliver significant health care system savings. This transaction builds on that mission to include the rapidly growing checkpoint inhibitor market, which is expected to exceed US$25 billion by 2025, and provides us the essential backbone drug for development of next-generation combination therapies."

    More than 2,100 patients have received toripalimab treatment in clinical trials, and toripalimab is approved for second-line treatment of unresectable or metastatic melanoma in China where it is marketed by Junshi Biosciences and is included on the National Reimbursement Drug List (NRDL). Over the next three years, significant data are expected to read out from the extensive registrational development program, which includes 15 ongoing or completed international/domestic multi-center pivotal clinical trials evaluating toripalimab in multiple treatment settings for a broad range of solid tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    The United States Food and Drug Administration (FDA) has granted a breakthrough therapy designation to toripalimab for nasopharyngeal carcinoma (NPC), and the first toripalimab Biologics License Application (BLA) is expected to be filed with the FDA for this indication later this year. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma, and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Junshi Biosciences and Coherus plan to file additional toripalimab BLAs with the FDA over the next two years for several rare and highly prevalent cancers, including non small cell lung cancer (NSCLC).

    As part of the collaboration, Coherus has also acquired options or first negotiation rights to four of Junshi Biosciences' novel oncology molecules. The Companies may develop toripalimab in combination with one or more of these four compounds, and potentially with other cancer drugs:

    • An option to JS006, an antibody targeting TIGIT, a clinically validated immune inhibitory checkpoint. Anti-TIGIT antibodies have demonstrated significant synergistic anti-tumor activity in combination with anti-PD-1 antibodies. JS006 is expected to enter global clinical development later this year. The option term expires prior to initiation of Phase 2 development.
    • An option to JS018-1, a next-generation engineered IL-2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T-cells and natural killer ("NK") cells. The option term expires prior to initiation of Phase 2 development.
    • First negotiation rights to two undisclosed early-stage novel oncology programs directed against immune checkpoint molecules.

    Terms of the Junshi Biosciences – Coherus collaboration

    Under the terms of the agreement, Junshi Biosciences will receive up to an aggregate of US$1.11 billion of upfront payment, exercise fee and milestone payments from Coherus for the grant of the license of toripalimab and the two option programs (if exercised) in the United States and Canada.

    Junshi Biosciences will grant Coherus exclusive rights to toripalimab in the United States and Canada as well as options in these territories to Junshi Biosciences' JS006 and JS018-1. Coherus will also have first negotiation rights to two undisclosed preclinical immuno-oncology programs. Junshi Biosciences will receive an upfront payment of US$150 million. For toripalimab, Junshi Bioscience will receive 20% royalty on the annual net sales of toripalimab and up to an aggregate $380 million in one-time payments for the achievement of various milestones. For JS006 and JS108-1, Junshi Biosciences will receive an opt-in payment of $35 million per program. Additionally, for each program, Junshi Biosciences will receive 18% royalty on the annual net sales and up to an aggregate $255 million for the achievement of various milestones. The Companies will collaborate on the development of toripalimab and other licensed compounds, and Coherus will pay for a portion of these co-development activities up to a maximum of US$25 million per licensed compound per year.

    About toripalimab (TUOYI®)

    Toripalimab is the first domestic anti-PD-1 monoclonal antibody to obtain a marketing approval in China. So far, more than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of patients with unresectable or metastatic melanoma. Supplemental NDAs of toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In December 2020, toripalimab was included in the National Reimbursement Drug List (NRDL) for the treatment of melanoma by the China National Healthcare Security Administration (NHSA).

    In the United States, the FDA has granted toripalimab breakthrough therapy designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma, Fast Track designation for mucosal melanoma, and orphan drug designation for the treatment of nasopharyngeal carcinoma, mucosal melanoma and soft tissue sarcoma.

    About the toripalimab clinical development program

    Toripalimab is being evaluated in an extensive registrational clinical development program for a broad range of solid tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    • Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Patients With Locally Advanced or Metastatic Melanoma (POLARIS-01) - NCT03013101
    • Phase 1b/2 trial evaluating toripalimab in patients with advanced gastric adenocarcinoma, ESCC, NPC and head and neck squamous cell carcinoma (POLARIS-02) - NCT02915432
    • Safety and Efficacy of Toripalimab for Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma (POLARIS-03) - NCT03113266
    • A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers - NCT04603040
    • Phase III Study of Comparing TORIPALIMAB INJECTION Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasophapyngeal Cancer - NCT03581786
    • Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Curative Hepatic Resection (JUPITER-04) - NCT03859128
    • A Phase III Study to Investigate Toripalimab Versus Dacarbazine as the First Line Therapy for Unresectable or Metastatic Melanoma (JS001) - NCT03430297
    • A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC (CHOICE-01) - NCT03856411
    • Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma (JUPITER-06) - NCT03829969
    • Toripalimab Plus Pemetrexed+Platinus in Advanced Non-small-cell Lungcancer Patients Previsouly Treated EGFR-TKI - NCT03924050
    • Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment (TORCHLIGHT) - NCT04085276
    • Phase 3 trial comparing toripalimab + lenvantinib vs. lenvantinib alone as a 1st line treatment for patients with advanced HCC - NCT04523493
    • Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer - NCT04012606
    • A Study of Toripalimab or Placebo Plus Chemotherapy as Treatment in Early Stage NSCLC - NCT04158440
    • Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer - NCT04394975
    • A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma - NCT04568304

    About JS006

    JS006 is a recombinant humanized IgG4κ monoclonal antibody against human TIGIT specifically, developed independently by Junshi Biosciences. According to the results of pre-clinical studies, JS006 can specifically block the TIGIT-PVR pathway.

    About JS018-1

    JS018-1 is a next-generation engineered IL-2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T-cells and natural killer (NK) cells.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China's first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences, Inc.

    Coherus is a commercial stage biopharmaceutical company with the mission to increase patient access to cost-effective medicines that can have a major impact on their lives and to deliver significant savings to the health care system.

    In January 2021, Coherus in-licensed Junshi Biosciences' toripalimab, an anti-PD-1 antibody, which will be a cornerstone of Coherus' strategy to build a leading immuno-oncology franchise in the United States and Canada funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    For additional information, please visit www.coherus.com.

    Contact Information

    IR Team:

    Junshi Biosciences

    info@junshipharma.com 

    + 86 021-2250 0300

    Solebury Trout

    Bob Ai

    bai@soleburytrout.com 

    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li

    zhi_li@junshipharma.com 

    + 86 021-6105 8800 



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  31. - Coherus to pay $150 million upfront for U.S. and Canada rights to toripalimab, an extensively studied, late-stage anti-PD-1 antibody
    - First U.S. BLA filing expected this year for nasopharyngeal carcinoma with breakthrough therapy designation
    - Options to PD-1 combination agents, TIGIT and IL-2, add long-term growth potential
    - Conference call at 8:00 am Eastern Time today

    REDWOOD CITY, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced a collaboration with Shanghai Junshi Biosciences, Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) for the development and commercialization of toripalimab, Junshi Biosciences' anti-PD-1 antibody, in the United States and Canada. Upon satisfaction…

    - Coherus to pay $150 million upfront for U.S. and Canada rights to toripalimab, an extensively studied, late-stage anti-PD-1 antibody

    - First U.S. BLA filing expected this year for nasopharyngeal carcinoma with breakthrough therapy designation

    - Options to PD-1 combination agents, TIGIT and IL-2, add long-term growth potential

    - Conference call at 8:00 am Eastern Time today

    REDWOOD CITY, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS) today announced a collaboration with Shanghai Junshi Biosciences, Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) for the development and commercialization of toripalimab, Junshi Biosciences' anti-PD-1 antibody, in the United States and Canada. Upon satisfaction of closing conditions, Coherus and Junshi Biosciences will co-develop toripalimab, and Coherus will be responsible for all commercial activities in the licensed territory. Under the terms of the agreement, Coherus will also be granted options to Junshi Biosciences' TIGIT-targeted antibody and next generation engineered IL-2 cytokine for evaluation as potential combination therapies with toripalimab, as well as certain negotiation rights to two early-stage checkpoint inhibitor antibodies.

    "Toripalimab has a compelling late-stage clinical profile and will be the cornerstone of our immuno-oncology franchise. This transaction expands our late-stage pipeline into the rapidly growing checkpoint inhibitor market, which is expected to exceed $25 billion in the United States by 2025, and provides us a PD-1 backbone for potential long-term growth with next-generation immuno-oncology combinations," said Denny Lanfear, CEO of Coherus. "Junshi Biosciences is an innovation-driven biopharmaceutical company with global clinical research capabilities, and we are excited to collaborate with them as we build on our success in oncology with biosimilars and broaden our mission of expanding patient access and delivering health care system savings to larger markets."

    "We believe Coherus is the right partner for us in North America. Their commercial team has demonstrated remarkable ability to gain significant share of the oncology market against entrenched large competitors," said Dr. Ning LI, CEO of Junshi Biosciences. "Toripalimab could be the first marketed Chinese anti-PD-1 antibody in the overseas market. The collaboration with Coherus will be a critical step to build up our global commercial network. We look forward to working closely with Coherus to establish toripalimab's position in the United States and Canadian markets in order to provide patients with affordable high-quality innovative care."

    More than 2,100 patients have received toripalimab treatment in clinical trials, and toripalimab is approved for second-line treatment of unresectable or metastatic melanoma in China where it is marketed by Junshi Biosciences and is included on the National Reimbursement Drug List ("NRDL") for the treatment of melanoma. Over the next three years, significant data are expected to read out from the extensive registrational development program, which includes 15 ongoing and completed pivotal clinical trials evaluating toripalimab in multiple treatment settings for a broad range of solid tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    The United States Food and Drug Administration ("FDA") has granted breakthrough therapy designation to toripalimab for 3rd line nasopharyngeal carcinoma ("NPC"), and Coherus expects the first toripalimab biologics license application ("BLA") to be filed with the FDA for this indication later this year. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma, and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare and highly prevalent cancers, including non-small cell lung cancer ("NSCLC").

    As part of the collaboration, Coherus will also be granted options and certain negotiation rights to four of Junshi Biosciences' novel oncology molecules for potential development in combination with toripalimab:

    • JS006, an antibody targeting TIGIT, a clinically validated immune inhibitory checkpoint. Anti-TIGIT antibodies have demonstrated synergistic anti-tumor activity in combination with anti-PD-1 antibodies. Coherus expects this compound to enter clinical development later this year. The option to JS006 is exercisable prior to initiation of Phase 2 clinical development.
    • JS018, a next-generation engineered IL-2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T cells and natural killer ("NK") cells. The option to JS018 is exercisable prior to initiation of Phase 2 clinical development.
    • Two additional undisclosed early-stage novel immuno-oncology drug candidates to which Coherus will also be granted certain negotiation rights.

    Mr. Lanfear provided further comment on Coherus' corporate strategy: "We plan to invest the cash generated by our biosimilar commercial business to build a focused immuno-oncology franchise, which will leverage our development and commercial capabilities into large and growing markets. We will prudently allocate our R&D resources to realize the exciting potential of toripalimab in both the monotherapy and combination settings. With respect to biosimilars, our focus will be commercialization, as we continue to pursue UDENYCA® market share growth and prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved."

    Coherus is discontinuing the development of CHS-2020 (Eylea® biosimilar candidate) and will direct those capital and development resources to the toripalimab monotherapy and combinations program.

    Terms of the Coherus – Junshi Biosciences collaboration

    Under the terms of the agreement, Coherus will pay $150 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences' anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. Coherus will also pay Junshi Biosciences a 20% royalty on net sales of toripalimab and up to an aggregate $380 million in one-time payments for the achievement of various milestones, including up to $290 million for attainment of certain sales thresholds. The option exercise fee for each of the anti-TIGIT antibody and the IL-2 cytokine is $35 million per program. Additionally, for each option program, Coherus will pay Junshi Biosciences an 18% royalty on net sales and up to an aggregate $255 million for the achievement of various milestones, including up to $170 million for attainment of certain sales thresholds. The Companies will collaborate in the development of toripalimab and the other licensed compounds, and Coherus will pay for a portion of these co-development activities up to a maximum of $25 million per licensed compound per year.

    Closing of the collaboration agreement is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act.

    Jonathan Lanfear of Lanfear Advisors LLC led negotiations on behalf of Coherus, and Ropes & Gray LLP provided licensee's legal counsel.

    Conference call at 8:00 am Eastern Time

    Webcast: The conference call will be broadcast live in listen-only mode on the Company's investor relations website at https://investors.coherus.com/. If you would like to ask a question, the dial in number for the conference call is (844) 452-6826 (Toll Free U.S. and Canada) or (765) 507-2587 (International).

    Conference ID: 7784059

    Please dial-in 15 minutes early to ensure a timely connection to the call.

    A link to the conference call replay will be available on the Coherus website for two weeks following the call.

    About toripalimab (approved in China as TUOYI®)

    Toripalimab is the first Chinese domestic anti-PD-1 monoclonal antibody to obtain a marketing approval in China. More than thirty company-sponsored toripalimab clinical studies covering more than 15 indications have been conducted globally, including in China and the United States. In December 2018, toripalimab obtained a conditional approval from China's National Medical Products Administration ("NMPA") for the second-line treatment of patients with unresectable or metastatic melanoma. Supplemental NDAs of toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In December 2020, toripalimab was included in the NRDL for the treatment of melanoma by the China National Healthcare Security Administration (NHSA).

    In the United States, the FDA has granted toripalimab breakthrough therapy designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma, Fast Track designation for mucosal melanoma, and orphan drug designation for the treatment of nasopharyngeal carcinoma, mucosal melanoma and soft tissue sarcoma.

    About the toripalimab clinical development program

    Toripalimab is being evaluated in an extensive registrational clinical development program for a broad range of solid tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

    • Safety and Efficacy of Recombinant Humanized Anti-PD-1 mAb for Patients With Locally Advanced or Metastatic Melanoma (POLARIS-01) - NCT03013101
    • Phase 1b/2 trial Evaluating Toripalimab in Patients with Advanced Gastric Adenocarcinoma, ESCC, NPC and Head and Neck Squamous Cell Carcinoma (POLARIS-02) - NCT02915432
    • Safety and Efficacy of Toripalimab for Patients With Locally Advanced or Metastatic Bladder Urothelial Carcinoma (POLARIS-03) - NCT03113266
    • A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive for Specific Markers - NCT04603040
    • Phase III Study of Comparing TORIPALIMAB INJECTION Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer - NCT03581786
    • Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Curative Hepatic Resection (JUPITER-04) - NCT03859128
    • A Phase III Study to Investigate Toripalimab Versus Dacarbazine as the First Line Therapy for Unresectable or Metastatic Melanoma (JS001) - NCT03430297
    • A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC (CHOICE-01) - NCT03856411
    • Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma (JUPITER-06) - NCT03829969
    • Toripalimab Plus Pemetrexed+Platinus in Advanced Non-small-cell Lung cancer Patients Previously Treated with EGFR-TKI - NCT03924050
    • Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment (TORCHLIGHT) - NCT04085276
    • Phase 3 Trial Comparing Toripalimab + Lenvatinib vs. Lenvatinib Alone as a 1st line Treatment for Patients with Advanced HCC - NCT04523493
    • Toripalimab in Combination With Platinum Plus Etoposide in Patients With Extensive-Stage Small Cell Lung Cancer - NCT04012606
    • A Study of Toripalimab or Placebo Plus Chemotherapy as Treatment in Early Stage NSCLC - NCT04158440
    • Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer - NCT04394975
    • A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma - NCT04568304

    About JS006

    JS006 is a recombinant humanized IgG4κ monoclonal antibody against human TIGIT specifically, developed independently by Junshi Biosciences. According to the results of preclinical studies, JS006 can specifically block the TIGIT-PVR pathway.

    About JS018

    JS018 is a next-generation engineered IL-2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T cells and natural killer ("NK") cells.

    About Junshi Biosciences

    Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising 27 innovative drug candidates and two biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA, and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China's first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now a part of the company's continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

    About Coherus BioSciences, Inc.

    Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients' lives and to deliver significant savings to the health care system.

    In February 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, in the United States and Canada. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch biosimilars of Humira®, Avastin® and Lucentis®, if approved.

    For additional information, please visit www.coherus.com.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business; Coherus' and Junshi Biosciences' ability to co-develop toripalimab, and Coherus' ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus' ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; Coherus' ability to use toripalimab as a PD-1 backbone for potential long-term growth with next-generation immuno-oncology drug combinations; Coherus' ability to build on its success in oncology with biosimilars; Coherus' ability to successfully compete against entrenched large competitors in the oncology and checkpoint inhibitor markets; Coherus' ability to broaden its mission of expanding patient access and delivering health care system savings to larger markets; toripalimab's possibility to be the first marketed Chinese anti-PD-1 antibody in the overseas market; Coherus' and Junshi Biosciences' plans to file additional toripalimab BLAs with the FDA over the next three years for any clinical indication; the expectation to obtain significant data to read out over the next three years for any indication; Coherus' intentions to exercise its option to JS006 prior to initiation of Phase 2 clinical development; Coherus' expectations for JS006 to enter clinical development later in 2021; Coherus' plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus' ability to prudently allocate its R&D resources to realize the potential of toripalimab in both the monotherapy and combination settings; Coherus' ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved; Coherus' ability to discontinue the development of CHS-2020 (Eylea® biosimilar candidate) and direct capital and development resources to the toripalimab monotherapy and combinations program.

    Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risk that the parties are unable to obtain clearance under the Hart-Scott Rodino Antitrust Improvements Act, from the Committee on Foreign Investment in the United States, or any other statute or regulatory agency having jurisdiction with respect to the proposed transactions, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 27, 2020, its Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020, filed with the Securities and Exchange Commission on November 5, 2020 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended September 30, 2020 are not necessarily indicative of our operating results for any future periods.

    Contact

    McDavid Stilwell

    EVP, Financial Strategy and IR

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152 



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  32. REDWOOD CITY, Calif., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective January 21, 2021, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 60,000 shares of the common stock of the Company to 3 newly hired non-officer employees, with a per share exercise price of $17.99, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter…

    REDWOOD CITY, Calif., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective January 21, 2021, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 60,000 shares of the common stock of the Company to 3 newly hired non-officer employees, with a per share exercise price of $17.99, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

    About Coherus BioSciences, Inc.

    Coherus is a leading commercial-stage biosimilar company dedicated to expanding access to high-quality therapeutics that can have a major impact on patients' lives and to delivering significant savings to the health care system. For additional information, please visit www.coherus.com.

    Contact

    McDavid Stilwell

    EVP, Corporate Development, IR and Financial Strategy

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152



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  33. REDWOOD CITY, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced the appointments of Alan C. Mendelson and Mark D. Stolper to its Board of Directors effective January 5, 2021. 

    "We are excited to welcome Alan and Mark to the Coherus Board of Directors," said Denny Lanfear, President and CEO of Coherus. "Alan is a distinguished and highly regarded legal advisor who during his long career has supported life science and technology companies through all organizational stages and diverse corporate challenges. With broad experience in investment banking, venture capital, corporate finance and operations, Mark brings to Coherus an entrepreneurial mindset and a wealth of financial leadership…

    REDWOOD CITY, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced the appointments of Alan C. Mendelson and Mark D. Stolper to its Board of Directors effective January 5, 2021. 

    "We are excited to welcome Alan and Mark to the Coherus Board of Directors," said Denny Lanfear, President and CEO of Coherus. "Alan is a distinguished and highly regarded legal advisor who during his long career has supported life science and technology companies through all organizational stages and diverse corporate challenges. With broad experience in investment banking, venture capital, corporate finance and operations, Mark brings to Coherus an entrepreneurial mindset and a wealth of financial leadership experience in public and private healthcare companies."

    Mr. Mendelson served as a partner at Latham & Watkins LLP from May 2000 to December 2020, where he held several leadership roles, including Co-Chair of the Emerging Companies Practice Group and Global Co-Chair of the Life Sciences Industry Group, and advised numerous private and public companies, primarily in the life sciences industry. Prior to joining Latham & Watkins, Mr. Mendelson was a partner at Cooley LLP from February 1980 to May 2000. From November 1995 to June 1996, he served as acting General Counsel of Cadence Design Systems Inc., a public EDA software and services company. Previously, from April 1990 to April 1991, he served as secretary and acting general counsel of Amgen Inc. Mr. Mendelson previously served on the boards of directors of several public biotech companies including Aviron Inc., CV Therapeutics, Inc., QLT, Inc., and Valentis, Inc. He has served as the corporate secretary for Mellanox Technologies, Ltd., Intuitive Surgical, Inc., Corvus Pharmaceuticals, Inc., Eargo, Inc. and 4D Molecular Therapeutics, Inc. Mr. Mendelson also currently serves on the board of directors of the California Life Sciences Association and the boards of trustees of the University of California, Berkeley Foundation and The Buck Institute for Research on Aging. Mr. Mendelson received a B.A. in Political Science from the University of California, Berkeley and a J.D. from Harvard Law School.

    Mr. Stolper has served as Executive Vice President and Chief Financial Officer of RadNet, Inc., a publicly traded operator of medical diagnostic imaging centers, since July 2004. He has served on the board of directors of Surgalign Holdings, Inc., a publicly traded medical technology company, since March 2017, and Rotech Healthcare Inc., a privately held medical equipment company, since February 2016. Previously, Mr. Stolper served as a member of the board of directors of 21st Century Oncology Holdings, Inc., Surgical Solutions LLC, Physiotherapy Associates, Inc., Metropolitan Health Networks, Inc., and Compumed, Inc. Mr. Stolper graduated with a B.A. in Economics from the University of Pennsylvania and a B.S.E. in Finance from the Wharton School. Additionally, Mr. Stolper earned a postgraduate Award in Accounting from the University of California, Los Angeles.

    About Coherus BioSciences, Inc.

    Coherus is a leading commercial-stage biosimilar company dedicated to expanding access to high-quality therapeutics that can have a major impact on patients' lives and to delivering significant savings to the health care system. For additional information, please visit www.coherus.com.

    Contact

    McDavid Stilwell

    EVP of Corporate Development, IR and Financial Strategy

    Coherus BioSciences, Inc.

    mstilwell@coherus.com

    +1 (650) 395-0152

    Source: Coherus BioSciences, Inc.



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  34. REDWOOD CITY, Calif., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that senior management will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 10:50 a.m. EST / 7:50 a.m. PST.

    The audio portion of the Company presentation will be available on the investors page of the Coherus BioSciences website at https://investors.coherus.com.

    About Coherus BioSciences, Inc.

    Coherus is a leading commercial-stage biosimilar company dedicated to expanding access to high-quality therapeutics that can have a major impact on patients' lives and to delivering significant savings to the health care system. For additional information, please visit www.coherus.com

    REDWOOD CITY, Calif., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that senior management will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 10:50 a.m. EST / 7:50 a.m. PST.

    The audio portion of the Company presentation will be available on the investors page of the Coherus BioSciences website at https://investors.coherus.com.

    About Coherus BioSciences, Inc.

    Coherus is a leading commercial-stage biosimilar company dedicated to expanding access to high-quality therapeutics that can have a major impact on patients' lives and to delivering significant savings to the health care system. For additional information, please visit www.coherus.com.



    Contact
    
    McDavid Stilwell
    EVP, Corporate Development, IR and Financial Strategy 
    Coherus BioSciences, Inc.
    mstilwell@coherus.com
    +1 (650) 395-0152

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  35. REDWOOD CITY, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective December 17, 2020, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 66,000 shares of the common stock of the Company to 5 newly hired non-officer employees, with a per share exercise price of $17.78, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to…

    REDWOOD CITY, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective December 17, 2020, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 66,000 shares of the common stock of the Company to 5 newly hired non-officer employees, with a per share exercise price of $17.78, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

    About Coherus BioSciences, Inc.

    Coherus is a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to the United States market. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing, clinical-regulatory development and commercialization, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus commercializes UDENYCA® (pegfilgrastim-cbqv) in the United States and is advancing additional product candidates including CHS-1420, a Humira® (adalimumab) biosimilar, Bioeq's Lucentis® (ranibizumab) biosimilar, Innovent's Avastin® (bevacizumab) biosimilar towards commercialization, as well as CHS-2020, an Eylea® (aflibercept) biosimilar. For additional information, please visit www.coherus.com.

    Contact

    David S. Arrington

    Investor Relations & Corporate Affairs

    Coherus BioSciences, Inc.

    darrington@coherus.com

    +1 (650) 395-0196



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  36. REDWOOD CITY, Calif., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective November 19, 2020, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 140,500 shares of the common stock of the Company to 10 newly hired non-officer employees, with a per share exercise price of $17.92, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to…

    REDWOOD CITY, Calif., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective November 19, 2020, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 140,500 shares of the common stock of the Company to 10 newly hired non-officer employees, with a per share exercise price of $17.92, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

    About Coherus BioSciences, Inc.

    Coherus is a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to the United States market. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing, clinical-regulatory development and commercialization, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus commercializes UDENYCA® (pegfilgrastim-cbqv) in the United States and is advancing additional product candidates including CHS-1420, a Humira® (adalimumab) biosimilar, Bioeq's Lucentis® (ranibizumab) biosimilar, Innovent's Avastin® (bevacizumab) biosimilar towards commercialization, as well as CHS-2020, an Eylea® (aflibercept) biosimilar. For additional information, please visit www.coherus.com.

    Contact

    David S. Arrington

    Investor Relations & Corporate Affairs

    Coherus BioSciences, Inc.

    darrington@coherus.com

    +1 (650) 395-0196



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  37. – Third Quarter UDENYCA® Net Sales of $113.6 Million –
    – Net Income of $27.9 Million –
    – Non-GAAP Net Income of $39.7 Million –

    REDWOOD CITY, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today reviewed corporate events and reported financial results for the third quarter and nine months ended September 30, 2020.

    "In September, Coherus celebrated its ten year anniversary, and I am thrilled by what we have accomplished at this milestone," said Denny Lanfear, Coherus President and CEO. "Coherus is fully integrated with competencies in research, development, and commercialization, and we are successfully fulfilling our mission to deliver value to patients by providing them access…

    – Third Quarter UDENYCA® Net Sales of $113.6 Million –

    – Net Income of $27.9 Million –

    – Non-GAAP Net Income of $39.7 Million –

    REDWOOD CITY, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today reviewed corporate events and reported financial results for the third quarter and nine months ended September 30, 2020.

    "In September, Coherus celebrated its ten year anniversary, and I am thrilled by what we have accomplished at this milestone," said Denny Lanfear, Coherus President and CEO. "Coherus is fully integrated with competencies in research, development, and commercialization, and we are successfully fulfilling our mission to deliver value to patients by providing them access to cost effective drugs that can have a major impact on their lives. Moreover, our Udenyca business is generating significant cash flow, enabling investments in our pipeline of product candidates which, if approved, would expand our addressable market opportunity from $4 billion to $30 billion."

    Third Quarter 2020 and Recent Corporate Highlights

    • Net product revenue for the third quarter of 2020 was $113.6 million, and net income was $27.9 million, or $0.33 per share on a diluted basis.

    • Non-GAAP income during the third quarter of 2020 was $39.7 million, or $0.47 per share on a diluted basis.
    • Cash flow from operating activities was $47.4 million for the third quarter of 2020.

    Third Quarter 2020 Financial Results

    Net product revenue for the third quarter of 2020 was $113.6 million. Cost of goods sold for the third quarter of 2020 was $9.0 million, resulting in a gross profit margin of 92%.

    Research and development (R&D) expense for the third quarter of 2020 was $38.9 million, as compared to $21.6 million for the same period in 2019. R&D expense for the nine months ended September 30, 2020 was $98.1 million, as compared to $59.2 million for the same period in 2019. The increase in R&D expense in both periods was primarily due to preparations for the biologics license application (BLA) filing of CHS-1420, Coherus' biosimilar to Humira® (adalimumab), as well as other pipeline activities.

    Selling, general and administrative (SG&A) expense for the third quarter of 2020 was $32.0 million, as compared to $31.8 million for the same period in 2019. SG&A expense for the nine months ended September 30, 2020 was $101.4 million, as compared to $101.0 million for the same period in 2019. 

    Cash, cash equivalents and investments in marketable securities for the third quarter increased to $503.4 as of September 30, 2020, as compared to $456.5 million as of June 30, 2020 and $177.7 million as of December 31, 2019. The increase in the third quarter of 2020 is primarily due to generating $47.4 million in net cash from operating activities.

    Net income for the third quarter of 2020 was a $27.9 million, or $0.33 per share on a diluted basis, compared to $47.0 million, or $0.63 per share on a diluted basis for the same period in 2019.

    Non-GAAP net income for the third quarter of 2020 was $39.7 million, or $0.47 per share on a diluted basis, compared to non-GAAP income of $55.7 million, or $0.74 per share on a diluted basis for the same period in 2019. See "Non-GAAP Financial Measures" below for a discussion on how the Company calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measures.

    Guidance for the Next Twelve Months from September 30, 2020

    Coherus will continue to lay the foundation for long-term growth across its three therapeutic areas:

    Oncology

    • Deliver continued unit share growth with UDENYCA® against all Neulasta® dosage forms, while maintaining average selling price ("ASP") discipline, leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments.
    • Advance the Company's biosimilar candidate to Avastin® (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, depending on the outcome of the three-way pharmacokinetic ("PK") study, the timing of required interactions with the FDA, as well as completion of analytical similarity exercises.

    Ophthalmology

    • Facilitate Bioeq's resubmission of a 351(k) BLA with the FDA for the biosimilar candidate to Lucentis® (ranibizumab) in 2021.
    • Advance the Company's internally developed CHS-2020 biosimilar candidate to Eylea® (aflibercept) to a projected Phase 3 clinical trial initiation in 2021, with launch projected in 2025, if approved.

    Immunology

    • Submit the 351(k) BLA for the Company's internally developed Humira® (adalimumab) biosimilar, CHS-1420, by year end 2020, consistent with prior guidance, and continue other activities to advance toward a projected market entry in the United States on or after July 1, 2023, if approved.

    Financial Guidance

    • R&D and SG&A expenses combined for the full fiscal year 2020 are expected to come in at the low end of the previously stated range of $285 million to $310 million, excluding upfront or milestone payments from any potential new collaborations.

    Conference Call Information

    When: Thursday, November 5, 2020 starting at 4:30 p.m. ET

    Webcast: at https://investors.coherus.com.

    The conference call will be broadcast live in listen-only mode on the Company's investor relations website at https://investors.coherus.com/. If you would like to ask a question, the dial in number for the conference call is 844-452-6826 (Toll-Free U.S. and Canada) or 765-507-2587 (International).

    Conference ID: 7079429

    Please dial-in 15 minutes early to ensure a timely connection to the call.

    Third quarter 2020 financial results are posted on the Coherus website at https://investors.coherus.com/. The webcast will be archived on the Coherus website.

    About Coherus BioSciences, Inc.

    Coherus is a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to the United States market. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing, clinical-regulatory development and commercialization. Coherus is positioned as a leader in the global biosimilar marketplace. Coherus commercializes UDENYCA® (pegfilgrastim-cbqv) in the United States and is advancing additional product candidates including CHS-1420, a Humira® (adalimumab) biosimilar, Bioeq's Lucentis® (ranibizumab) biosimilar, Innovent's Avastin® (bevacizumab) biosimilar towards commercialization, as well as CHS-2020, an Eylea® (aflibercept) biosimilar. For additional information, please visit www.coherus.com.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to generate cash flow from its UDENYCA® business, Coherus' ability to expand its addressable market opportunity and to lay the foundation for long-term growth across its three therapeutic areas; Coherus' ability to deliver continued unit share growth with UDENYCA® against all Neulasta® dosage forms, Coherus' ability to maintain ASP discipline, leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments; Coherus' ability to advance the Company's oncology biosimilar candidate to Avastin® (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, depending on the outcome of the three-way PK study, the timing of required interactions with the FDA, as well as completing analytical similarity exercises; Coherus' ability to submit a 351(k) BLA with the FDA in 2021 for the Innovent biosimilar candidate to Avastin®; Coherus' ability to launch Innovent's biosimilar candidate to Avastin® in the United States; Coherus' ability to facilitate Bioeq's resubmission of a 351(k) BLA with the FDA for the ophthalmology biosimilar candidate to Lucentis® (ranibizumab) in 2021 and Coherus' ability to launch the product, if approved; Coherus' ability to advance CHS-2020 an Eylea® (aflibercept) ophthalmology biosimilar currently in preclinical development by initiating an projected Phase 3 clinical trial in 2021, with launch projected in 2025, if approved; Coherus' ability to submit the 351(k) BLA for CHS-1420, a Humira® (adalimumab) biosimilar by year end 2020, and continue other activities to advance toward a projected market entry in the United States on or after July 1, 2023; and Coherus' ability to meet its R&D and SG&A expenses guidance for the full fiscal year 2020. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 27, 2020, its Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020, filed with the Securities and Exchange Commission on November 5, 2020 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended September 30, 2020 are not necessarily indicative of our operating results for any future periods.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Neulasta® and Onpro® are registered trademarks of Amgen Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc.





    Coherus BioSciences, Inc.
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
    (unaudited)
                
     Three Months Ended Nine Months Ended
     September 30, September 30,
     2020  2019     2020     2019 
    Revenue:               
    Net product revenue$113,551  $111,684  $365,405  $232,215 
    Operating expenses:           
    Cost of goods sold 9,000   6,447   25,994   9,273 
    Research and development 38,851   21,568   98,131   59,240 
    Selling, general and administrative 31,984   31,828   101,386   100,967 
    Total operating expenses 79,835   59,843   225,511   169,480 
    Income from operations 33,716   51,841   139,894   62,735 
    Interest expense (5,656)  (4,469)  (15,495)  (13,118)
    Other income, net 56   518   548   1,887 
    Net income before income taxes 28,116   47,890   124,947   51,504 
    Income tax provision 183   847   2,411   898 
    Net income$27,933  $47,043  $122,536  $50,606 
                    
    Net income per share:               
    Basic$0.39  $0.67  $1.72  $0.73 
    Diluted$0.33  $0.63  $1.52  $0.69 
                
    Weighted-average number of shares used in computing net income per share:              
    Basic 71,649,350   69,877,693   71,138,973   69,501,835 
    Diluted 87,470,337   78,530,227   82,043,469   72,872,076 
                





    Coherus BioSciences, Inc. 
    Condensed Consolidated Balance Sheets 
    (in thousands) 
    (unaudited) 
         
     September 30, December 31, 
     2020 2019 
    Assets     
    Cash and cash equivalents$292,465 $177,668 
    Investments in marketable securities 210,966   
    Trade receivables, net 160,707  141,992 
    Inventory 85,964  55,071 
    Other assets 53,631  34,196 
    Total assets$803,733 $408,927 
    Liabilities and Stockholders' Equity    
    Accrued rebates, fees and reserve$75,961 $51,120 
    Convertible notes due 2022 79,537  78,542 
    Convertible notes due 2022 - related parties 26,512  26,181 
    Convertible notes due 2026 222,718   
    Term loan 74,267  73,663 
    Other liabilities 69,007  74,207 
    Total stockholders' equity 255,731  105,214 
    Total liabilities and stockholders' equity$803,733 $408,927 
         





    Coherus BioSciences, Inc.
    Condensed Consolidated Cash Flow
    (in thousands)
    (unaudited)
            
     Three Months Ended  Nine Months Ended
     September 30, September 30,
      2020   2019   2020   2019 
    Cash, cash equivalents and restricted cash at beginning of the period$ 225,057  $ 106,762  $ 177,908  $ 73,191 
            
    Net cash provided by operating activities$ 47,353  $ 54,951  $ 121,021  $ 10,645 
            
       Purchases of investments in marketable securities (41,981)  (5,371)  (273,845)  (20,235)
       Proceeds from maturities of investments in marketable securities 63,000   6,000   63,000   15,000 
       Upfront and milestone based license fee payments to Innovent (2,500)  -   (7,500)   
       Purchases of property and equipment and other investing activities (2,112)  (918)  (6,112)  (1,435)
    Net cash provided by (used in) investing activities$ 16,407  $ (289) $ (224,457) $ (6,670)
            
       Proceeds (payments) related to issuance of Convertible Notes due 2026, net of issuance costs (674)     222,156    
       Purchase of capped call options related to convertible notes due 2026       (18,170)   
       Proceeds (payments) related to the term loan, net of issuance costs    (106)     72,955 
       Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs          8,153 
       Proceeds from issuance of common stock upon exercise of stock options 4,909   3,789   13,014   5,184 
       Proceeds from purchase under the employee stock purchase plan       2,557   1,878 
       Cash used in other financing activities (147)     (1,124)   
    Net cash provided by financing activities$ 4,088  $ 3,683  $ 218,433  $ 88,170 
            
    Effect of exchange rate changes on cash    59      (170)
            
    Net increase in cash, cash equivalents and restricted cash$ 67,848  $ 58,404  $ 114,997  $ 91,975 
            
    Cash, cash equivalents and restricted cash at end of the period$ 292,905  $ 165,166  $ 292,905  $ 165,166 
            
    Reconciliation of cash, cash equivalents, and restricted cash       
      Cash and cash equivalents$292,465  $165,116  $292,465  $165,116 
      Restricted cash – current    50      50 
      Restricted cash – non-current 440     440   
    Cash, cash equivalents and restricted cash$292,905  $165,166  $292,905  $165,166 
            



    Non-GAAP Financial Measures


    To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net income, and the related per share measures, which exclude from net income, and the related per share measures, stock-based compensation expense, upfront and milestone payments under the license agreements and the related income tax effect of those non-GAAP adjustments. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus' business.

    Coherus believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare Coherus' results from period to period, and to identify operating trends in Coherus' business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.



    Coherus BioSciences, Inc.
    Reconciliation of GAAP Net Income to Non-GAAP Net Income
    (in thousands, except share and per share data)
    (unaudited)
                
     Three Months Ended Nine Months Ended
     September 30, September 30,
     2020  2019     2020     2019 
    GAAP net income$27,933  $47,043  $122,536  $50,606 
    Adjustments:           
        Stock based compensation expense 9,308   8,790   28,287   26,319 
        Upfront and milestone based license fee payments to Innovent 2,500      7,500    
        Income tax effect of the above adjustments (77)  (155)  (691)  (459)
    Non-GAAP net income$39,664  $55,678  $157,632  $76,466 
                
    GAAP net income per share, basic$0.39  $0.67  $1.72  $0.73 
    GAAP net income per share, diluted$0.33  $0.63  $1.52  $0.69 
    Non-GAAP net income per share, basic$0.55  $0.80  $2.22  $1.10 
    Non-GAAP net income per share, diluted$0.47  $0.74  $1.93  $1.05 
                

     



    Contact


    David S. Arrington

    Investor Relations & Corporate Affairs

    Coherus BioSciences, Inc.

    darrington@coherus.com

    +1 (650) 395-0196

    Primary Logo

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  38. REDWOOD CITY, Calif., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that its third quarter 2020 financial results will be released after market close on Thursday, November 5, 2020. Starting at 4:30 p.m. EST, Coherus' management team will host a conference call to discuss financial results and provide a general business update.

    After releasing third quarter financial results, the Company will post them on the Coherus website at https://investors.coherus.com.

    Conference Call Information

    When: Thursday, November 5, 2020 starting at 4:30 p.m. EST

    Webcast: https://investors.coherus.com

    Dial-in: 844-452-6826 (Toll-Free U.S. and Canada) or 765-507-2587 (International)
    Please dial-in 15…

    REDWOOD CITY, Calif., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus", NASDAQ:CHRS), today announced that its third quarter 2020 financial results will be released after market close on Thursday, November 5, 2020. Starting at 4:30 p.m. EST, Coherus' management team will host a conference call to discuss financial results and provide a general business update.

    After releasing third quarter financial results, the Company will post them on the Coherus website at https://investors.coherus.com.

    Conference Call Information

    When: Thursday, November 5, 2020 starting at 4:30 p.m. EST

    Webcast: https://investors.coherus.com

    Dial-in: 844-452-6826 (Toll-Free U.S. and Canada) or 765-507-2587 (International)

    Please dial-in 15 minutes early to ensure a timely connection to the call.

    Conference ID: 7079429

    About Coherus BioSciences, Inc.

    Coherus is a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to the United States market. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus commercializes UDENYCA® (pegfilgrastim-cbqv) in the United States and is advancing additional product candidates including CHS-1420, a Humira® (adalimumab) biosimilar, Bioeq's Lucentis® (ranibizumab) biosimilar, Innovent's Avastin® (bevacizumab) biosimilar towards commercialization, as well as CHS-2020, an Eylea® (aflibercept) biosimilar. For additional information, please visit www.coherus.com.



    Contact

    David S. Arrington

    Investor Relations & Corporate Affairs

    Coherus BioSciences, Inc.

    darrington@coherus.com

    +1 (650) 395-0196 

    Primary Logo

    View Full Article Hide Full Article
  39. REDWOOD CITY, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective October 15, 2020, the compensation committee of the Company's board of directors granted a newly hired Executive Vice President an option to buy 150,000 shares of the Company's common stock with a per share exercise price of $18.09, the closing trading price on the grant date, and 10,000 restricted stock units.

    A newly hired Senior Vice President was granted an option to purchase 100,000 shares of the Company's common stock, and two newly hired Vice Presidents were each granted options to purchase 45,000 shares of the Company's common stock, all with a per share exercise price of $18.09…

    REDWOOD CITY, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective October 15, 2020, the compensation committee of the Company's board of directors granted a newly hired Executive Vice President an option to buy 150,000 shares of the Company's common stock with a per share exercise price of $18.09, the closing trading price on the grant date, and 10,000 restricted stock units.

    A newly hired Senior Vice President was granted an option to purchase 100,000 shares of the Company's common stock, and two newly hired Vice Presidents were each granted options to purchase 45,000 shares of the Company's common stock, all with a per share exercise price of $18.09, the closing trading price on the grant date.

    An aggregate of 92,000 shares of the common stock of the Company were also granted to seven newly hired non-officer employees, with a per share exercise price of $18.09, the closing trading price on the grant date.

    About Coherus BioSciences, Inc.

    Coherus is a leading biologics company that develops and commercializes its own high-quality biosimilar therapeutics as well as those of others seeking capable access to the United States market. Composed of a team of proven industry veterans with world-class expertise in product development and commercialization, Coherus is positioned as a leader in the global biosimilar marketplace. Headquartered in the United States, Coherus is committed to reducing healthcare system costs and expanding patient access of essential therapeutics.

    Coherus has commercialized UDENYCA® (pegfilgrastim-cbqv) in the United States and received regulatory approval for UDENYCA® in the European Union. Coherus is advancing late-stage clinical products CHS-1420, a Humira® (adalimumab) biosimilar, Bioeq's Lucentis® (ranibizumab) biosimilar and Innovent's Avastin® (bevacizumab) biosimilar towards commercialization. The Company is also advancing early-stage clinical products including, CHS-2020, an Eylea® (aflibercept) biosimilar. For additional information, please visit www.coherus.com.

    Contact

    David S. Arrington

    Investor Relations & Corporate Affairs

    Coherus BioSciences, Inc.

    darrington@coherus.com

    +1 (650) 395-0196

    Primary Logo

    View Full Article Hide Full Article
  40. REDWOOD CITY, Calif., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective September 17, 2020, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 118,000 shares of the common stock of the Company to six newly hired non-officer employees, with a per share exercise price of $19.07, the closing trading price on the grant date.

    A Vice President was also granted an option to purchase 45,000 shares of the Company's common stock, with a per share exercise price of $19.07, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement…

    REDWOOD CITY, Calif., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective September 17, 2020, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 118,000 shares of the common stock of the Company to six newly hired non-officer employees, with a per share exercise price of $19.07, the closing trading price on the grant date.

    A Vice President was also granted an option to purchase 45,000 shares of the Company's common stock, with a per share exercise price of $19.07, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

    About Coherus BioSciences, Inc.

    Coherus is a leading biologics company that develops and commercializes its own high-quality biosimilar therapeutics as well as those of others seeking capable access to the United States market. Composed of a team of proven industry veterans with world-class expertise in product development and commercialization, Coherus is positioned as a leader in the global biosimilar marketplace. Headquartered in the United States, Coherus is committed to reducing healthcare system costs and expanding patient access of essential therapeutics.

    Coherus has commercialized UDENYCA® (pegfilgrastim-cbqv) in the United States and received regulatory approval for UDENYCA® in the European Union. Coherus is advancing late-stage clinical products CHS-1420, a Humira® (adalimumab) biosimilar, Bioeq's Lucentis® (ranibizumab) biosimilar and Innovent's Avastin® (bevacizumab) biosimilar towards commercialization. The Company is also advancing early-stage clinical products including, CHS-2020, an Eylea® (aflibercept) biosimilar. For additional information, please visit www.coherus.com.

    Contact

    David S. Arrington

    Investor Relations & Corporate Affairs

    Coherus BioSciences, Inc.

    darrington@coherus.com

    +1 (650) 395-0196

     

    Primary Logo

    View Full Article Hide Full Article
  41. REDWOOD CITY, Calif., Aug. 21, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective August 19, 2020, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 64,000 shares of the common stock of the Company to seven newly hired non-officer employees, with a per share exercise price of $19.85, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees…

    REDWOOD CITY, Calif., Aug. 21, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today announced that effective August 19, 2020, the compensation committee of the Company's board of directors granted options to purchase an aggregate of 64,000 shares of the common stock of the Company to seven newly hired non-officer employees, with a per share exercise price of $19.85, the closing trading price on the grant date.

    The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Company's board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

    About Coherus BioSciences, Inc.

    Coherus is a leading biologics company that develops and commercializes its own high-quality biosimilar therapeutics as well as those of others seeking capable access to the United States market. Composed of a team of proven industry veterans with world-class expertise in product development and commercialization, Coherus is positioned as a leader in the global biosimilar marketplace. Headquartered in the United States, Coherus is committed to reducing healthcare system costs and expanding patient access of essential therapeutics.

    Coherus has commercialized UDENYCA® (pegfilgrastim-cbqv) in the United States and received regulatory approval for UDENYCA® in the European Union. Coherus is advancing late-stage clinical products CHS-1420, a Humira® (adalimumab) biosimilar, Bioeq's Lucentis® (ranibizumab) biosimilar and Innovent's Avastin® (bevacizumab) biosimilar towards commercialization. The Company is also advancing early-stage clinical products including, CHS-2020, an Eylea® (aflibercept) biosimilar. For additional information, please visit www.coherus.com.

    Contact

    David S. Arrington

    Investor Relations & Corporate Affairs

    Coherus BioSciences, Inc.

    darrington@coherus.com

    +1 (650) 395-0196

    Primary Logo

    View Full Article Hide Full Article
  42. – Second Quarter UDENYCA® Net Sales of $135.7 Million –
    – Net Income of $59.0 Million –
    – Non-GAAP Net Income of $68.3 Million –

    REDWOOD CITY, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today reviewed corporate events and reported financial results for the quarter ended June 30, 2020.

    Second Quarter 2020 and Recent Corporate Highlights

    • Net product revenue for the second quarter of 2020 was $135.7 million, and net income was $59.0 million, or $0.70 per share on a diluted basis.

    • Non-GAAP income during the second quarter of 2020 was $68.3 million, or $0.81 per share on a diluted basis.

    • Cash flow from operating activities was $60.2 million for the second quarter of 2020…

    – Second Quarter UDENYCA® Net Sales of $135.7 Million –

    – Net Income of $59.0 Million –

    – Non-GAAP Net Income of $68.3 Million –

    REDWOOD CITY, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (("Coherus" or the "Company", NASDAQ:CHRS), today reviewed corporate events and reported financial results for the quarter ended June 30, 2020.

    Second Quarter 2020 and Recent Corporate Highlights

    • Net product revenue for the second quarter of 2020 was $135.7 million, and net income was $59.0 million, or $0.70 per share on a diluted basis.



    • Non-GAAP income during the second quarter of 2020 was $68.3 million, or $0.81 per share on a diluted basis.



    • Cash flow from operating activities was $60.2 million for the second quarter of 2020.



    • The Healthcare Distribution Alliance recognized Coherus' successful launch of UDENYCA® (pegfilgrastim-cbqv) by awarding the 2019 Diana Award in the category for Best New Product Introductions in the Biotechnology Pharmaceutical Product sector.



    • The Company appointed veteran healthcare leader, Kimberly Tzoumakas, J.D. to its Board of Directors.

    Second Quarter 2020 Financial Results

    Net product revenue for the second quarter of 2020 was $135.7 million. Net product revenue included a favorable revision of the Company's prior period payer rebate estimate of $13.3 million recorded in the second quarter of 2020. Cost of goods sold for the second quarter of 2020 was $10.1 million, resulting in a gross profit margin of 93%.

    Research and development (R&D) expense for the second quarter of 2020 was $26.2 million, as compared to $18.9 million for the same period in 2019. R&D expense for the six months ended June 30, 2020 was $59.3 million, as compared to $37.7 million for the same period in 2019. The increase in R&D expense in both periods was primarily due to preparations for the biologics license application (BLA) filing of CHS-1420, Coherus' biosimilar to Humira® (adalimumab), and to the manufacturing scale-up to initiate planned clinical trials in 2021 for CHS-2020, Coherus' biosimilar to Eylea® (aflibercept).

    Selling, general and administrative (SG&A) expense for the second quarter of 2020 was $34.1 million, as compared to $36.5 million for the same period in 2019. SG&A expense for the six months ended June 30, 2020 was $69.4 million, as compared to $69.1 million for the same period in 2019. 

    Cash, cash equivalents and investments in marketable securities for the second quarter increased to $456.5 million as of June 30, 2020, as compared to $193.3 million as of March 31, 2020 and $177.7 million as of December 31, 2019. The increase in the second quarter of 2020 is primarily due to generating $60.2 million in net cash from operating activities and receiving $222.8 million in net proceeds from issuing convertible debt notes due 2026 in April 2020, which was offset by purchasing $18.2 million in capped call options related to the convertible notes.

    Net income for the second quarter of 2020 was a $59.0 million, or $0.70 per share on a diluted basis, compared to $23.6 million, or $0.32 per share on a diluted basis for the same period in 2019.

    Non-GAAP net income for the second quarter of 2020 was $68.3 million, or $0.81 per share on a diluted basis, compared to non-GAAP income of $31.5 million, or $0.43 per share on a diluted basis for the same period in 2019.  See "Non-GAAP Financial Measures" below for a discussion on how the Company calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measure.

    Guidance for the Remainder of 2020

    Coherus will continue to lay the foundation for long-term growth across its three therapeutic areas:

    Oncology

    • Deliver continued market success with UDENYCA® (pegfilgrastim-cbqv) against all Neulasta® dosage forms, while maintaining average selling price ("ASP") discipline, leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments.



    • Advance the Company's biosimilar candidate to Avastin® (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, depending on the outcome and the timing of required interactions with the FDA in completing a three-way pharmacokinetic ("PK") study, as well as completing additional analytical similarity exercises.

    Ophthalmology

    • Facilitate Bioeq's resubmission of a 351(k) BLA with the FDA for the biosimilar candidate to Lucentis® (ranibizumab) in the second half of 2020.



    • Advance the Company's internally developed CHS-2020 biosimilar candidate to Eylea® (aflibercept) to an expected Phase 3 clinical trial initiation in 2021, with launch projected in 2025, if approved.

    Immunology

    • Complete certain manufacturing, regulatory and development activities for the Company's internally developed Humira® (adalimumab) biosimilar, CHS-1420, and file the 351(k) BLA in the fourth quarter of 2020. The Company expects this timing will enable a projected market entry in the United States on or after July 1, 2023, if approved.

    Financial Guidance

    • R&D and SG&A expenses combined together are expected to range between $285 million and $310 million for the full fiscal year 2020, excluding upfront or milestone payments from any potential new collaborations, consistent with prior quarter guidance.

    Conference Call Information

    When: Thursday, August 6, 2020 starting at 4:30 p.m. ET

    Webcast: at https://investors.coherus.com.  

    The conference call will be broadcast live in listen-only mode on the Company's investor relations website at https://investors.coherus.com/. If you would like to ask a question, the dial in number for the conference call is 844-452-6826 (Toll-Free U.S. and Canada) or 765-507-2587 (International).

    Conference ID: 4956327

    Please dial-in 15 minutes early to ensure a timely connection to the call.

    Second quarter 2020 financial results are posted on the Coherus website at https://investors.coherus.com/. The webcast will be archived on the Coherus website.

    About Coherus BioSciences, Inc.

    Coherus is a leading biologics company that develops and commercializes its own high-quality biosimilar therapeutics as well as those of others seeking capable access to the United States market. Composed of a team of proven industry veterans with world-class expertise in product development and commercialization, Coherus is positioned as a leader in the global biosimilar marketplace. Headquartered in the United States, Coherus is committed to reducing healthcare system costs and expanding patient access of essential therapeutics.

    Coherus has commercialized UDENYCA® (pegfilgrastim-cbqv) in the United States and received regulatory approval for UDENYCA® in the European Union. Coherus is advancing late-stage clinical products CHS-1420, a Humira® (adalimumab) biosimilar, Bioeq's Lucentis® (ranibizumab) biosimilar and Innovent's Avastin® (bevacizumab) biosimilar towards commercialization. The Company is also advancing early-stage clinical products including, CHS-2020, an Eylea® (aflibercept) biosimilar. For additional information, please visit www.coherus.com.

    Forward-Looking Statements

    Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus' ability to lay the foundation for long-term growth across its three therapeutic areas; Coherus' ability to deliver continued market success with UDENYCA® (pegfilgrastim-cbqv) against all Neulasta® dosage forms, Coherus' ability to maintain average selling price ("ASP") discipline, leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments; Coherus' ability to advance its Innovent Avastin® (bevacizumab) oncology biosimilar candidate in-licensed from Innovent by completing a three-way PK study, as well as completing additional analytical similarity exercises; Coherus' ability to submit a 351(k) BLA with the FDA in 2021 for the Innovent biosimilar candidate to Avastin®; Coherus' ability to launch Innovent's biosimilar candidate to Avastin® in the United States; Coherus' ability to facilitate Bioeq's resubmission of a 351(k) BLA with the FDA for the ophthalmology biosimilar candidate to Lucentis® (ranibizumab) in the second half of 2020 and Coherus' ability to launch the product, if approved; Coherus' ability to advance CHS-2020 an Eylea® (aflibercept) ophthalmology biosimilar currently in preclinical development by initiating an expected Phase 3 clinical trial in 2021, with launch projected in 2025, if approved; Coherus' ability to complete certain manufacturing, regulatory and development activities for CHS-1420, a Humira® (adalimumab) immunology biosimilar, with an anticipated filing of a 351(k) BLA in the fourth quarter of 2020; Coherus' ability to have a projected market entry in the United States on or after July 1, 2023 for CHS-1420; and Coherus' ability to meet its R&D and SG&A expenses guidance for the full fiscal year 2020. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus' regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 27, 2020, its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2020, filed with the Securities and Exchange Commission on August 6, 2020 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended June 30, 2020 are not necessarily indicative of our operating results for any future periods.

    UDENYCA® is a trademark of Coherus BioSciences, Inc.

    Neulasta® and Onpro® are registered trademarks of Amgen Inc.

    Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

    Humira® is a registered trademark of AbbVie Inc.

    Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc.

     
    Coherus BioSciences, Inc.
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
    (unaudited)
                
     Three Months Ended Six Months Ended
     June 30, June 30,
     2020

     2019

     2020

     2019

    Revenue:           
    Net product revenue$135,674  $83,433  $251,854  $