CHRS Coherus BioSciences Inc.

13.95
-0.15  -1%
Previous Close 14.1
Open 14.05
52 Week Low 14.015
52 Week High 22.2166
Market Cap $1,015,471,557
Shares 72,793,660
Float 59,237,411
Enterprise Value $899,203,606
Volume 791,449
Av. Daily Volume 1,426,339
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Upcoming Catalysts

Drug Stage Catalyst Date
FYB201
Lucentis Biosimilar
BLA Filing
BLA Filing
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CHS-1420
Psoriasis
PDUFA
PDUFA
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Avastin (bevacizumab) biosimilar
BLA Filing
BLA Filing
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Drug Pipeline

Drug Stage Notes
Toripalimab
Nasopharyngeal carcinoma (NPC)
BLA Filing
BLA Filing
BLA rolling submission has been initiated - March 3, 2021.
CHS-1701
Pegfilgrastim biosimilar
Approved
Approved
FDA approval announced November 2, 2018.
CHS-0214
Psoriasis
Phase 3
Phase 3
Phase 3 trial met endpoint November 2015. However, commercialization not possible in US before 2029 due to patent issues
CHS-0214
Rheumatoid arthritis
Phase 3
Phase 3
Phase 3 data released January 2016. Endpoints met. However, commercialization not possible in US before 2029 due to patent issues

Latest News

  1. 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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  2. - 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



    + 86 021-2250 0300

    Solebury Trout

    Bob Ai



    + 1 646-389-6658

    PR Team:

    Junshi Biosciences

    Zhi Li



    + 86 021-6105 8800 

    Coherus BioSciences Contact Information:

    IR Contact

    McDavid Stilwell

    Coherus BioSciences, Inc.

    Media Contact

    Denise Powell



    Primary Logo

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  3. 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.



    +1 (650) 395-0152

     



    Primary Logo

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  4. - 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.



    +1 (650) 395-0152



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  5. 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.



    +1 (650) 395-0152



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