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REDWOOD CITY, Calif., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today reviewed corporate highlights and reported financial results for the quarter ended September 30, 2019.
Third Quarter 2019 Company Highlights
Third Quarter 2019 Financial Results
Guidance for the Next Twelve Months from September 30, 2019
Conference Call Information
Date: Wednesday, November 6, 2019 starting at 4:30 p.m. ET
Connect: Dial 844.452.6826 (toll free) or 765.507.2587 (international)
Enter: Conference ID: 8589299
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.
UDENYCA® (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA® drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.
UDENYCA® IS A LEUKOCYTE GROWTH FACTOR INDICATED TO DECREASE THE INCIDENCE OF INFECTION, AS MANIFESTED BY FEBRILE NEUTROPENIA, IN PATIENTS WITH NON-MYELOID MALIGNANCIES RECEIVING MYELOSUPPRESSIVE ANTI-CANCER DRUGS ASSOCIATED WITH A CLINICALLY SIGNIFICANT INCIDENCE OF FEBRILE NEUTROPENIA.
Limitations of Use
UDENYCA® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
IMPORTANT SAFETY INFORMATION
Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.
Warnings and Precautions
MOST COMMON ADVERSE REACTIONS (≥ 5% DIFFERENCE IN INCIDENCE COMPARED TO PLACEBO) ARE BONE PAIN AND PAIN IN EXTREMITY.
To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1- 800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Full Prescribing Information available at www.UDENYCA.com
About Coherus BioSciences, Inc.
Coherus is a leading biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. 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 U.S. and has received regulatory approval for UDENYCA® in the European Union. Coherus is advancing a late-stage clinical product CHS-1420 (adalimumab biosimilar) and Bioeq’s Lucentis® (ranibizumab biosimilar) towards commercialization, and early-stage clinical products, CHS-2020, an Eylea® (aflibercept biosimilar), and CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit www.coherus.com.
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 facilitate the Bioeq filing of a BLA with the FDA for their biosimilar candidate to Lucentis in the fourth quarter of 2019; Coherus’ ability to launch the Bioeq biosimilar candidate to Lucentis® (ranibizumab) in the United States in 2021; Coherus’ ability to maintain market position as the leading pegfilgrastim biosimilar of choice and to continue to validate its biosimilar-specific strategy of offering a robust value proposition across all key customer segments, including ample product supply; Coherus’ ability to achieve 2019 exit unit market share of 20% or greater, gain additional market share beyond 20% through 2020 and continue to increase penetration against all Neulasta dosage forms for UDENYCA®; Coherus’ plans to complete certain development and regulatory objectives to support a BLA filing in 2020 for CHS-1420; Coherus’ plans to launch Bioeq’s biosimilar to Lucentis in 2021, applying Coherus’ proficiencies and infrastructure developed for the oncology therapeutic commercial environment to the ophthalmology therapeutic commercial environment; Coherus’ ability to advance the development of CHS-2020, a biosimilar candidate to Eylea® (aflibercept); Coherus’ ability to effectively license its patents and applications for patents directed to Humira® (adalimumab) formulations to Pfizer. 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, 2019, filed with the Securities and Exchange Commission on August 1, 2019 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended June 30, 2019 are not necessarily indicative of our operating results for any future periods.
UDENYCA® is a trademark of Coherus BioSciences, Inc.
Neulasta® and Enbrel® are registered trademarks of Amgen Inc.
Humira® is a registered trademark of AbbVie Inc.
Lucentis® is a registered trademark of Genentech, 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)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Net product revenue||$||111,684||$||-||$||232,215||$||-|
|Cost of goods sold||6,447||-||9,273||-|
|Research and development||21,568||31,603||59,240||83,577|
|Selling, general and administrative||31,828||25,369||100,967||60,337|
|Total operating expenses||59,843||56,972||169,480||143,914|
|Income (loss) from operations||51,841||(56,972||)||62,735||(143,914||)|
|Other income, net||518||571||1,887||4,351|
|Net income (loss) before income tax||47,890||(58,826||)||51,504||(146,813||)|
|Income tax provision||847||-||898||-|
|Net income (loss)||47,043||(58,826||)||50,606||(146,813||)|
|Net loss attributable to non-controlling interest||-||18||-||70|
|Net income (loss) attributable to Coherus||$||47,043||$||(58,808||)||$||50,606||$||(146,743||)|
|Net income (loss) per share attributable to Coherus:|
|Weighted-average number of shares used in computing net income (loss) per share attributable to Coherus:|
|Coherus BioSciences, Inc.|
|Condensed Consolidated Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||165,116||$||72,356|
|Investments in marketable securities - short-term||5,377||-|
|Trade receivables, net||89,646||-|
|Liabilities and Stockholders’ Equity (Deficit)|
|Convertible notes - related parties||26,075||25,773|
|Total stockholders' equity (deficit)||56,023||(38,591||)|
|Total liabilities and stockholders’ equity (deficit)||$||327,383||$||99,467|
David S. Arrington
VP, Investor Relations & Corporate Affairs
Coherus BioSciences, Inc.
+1 (650) 395-0196