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REDWOOD CITY, Calif., Aug. 08, 2018 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: CHRS), today reviewed corporate highlights and reported financial results for the quarter ended June 30, 2018.
Second Quarter 2018 Corporate Highlights Include:
• On May 3, 2018, Coherus announced the re-submission of its biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) under the 351(k) pathway.
• On May 14, 2018, Coherus announced the FDA accepted and acknowledged for review the resubmission of this BLA.
• On May 28, 2018, Coherus submitted its day-181 responses to the European Medicines Agency’s day-180 questions regarding its marketing authorization application in Europe.
• On July 26, 2018, Coherus received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Second Quarter 2018 Financial Results:
Guidance for 2018:
UDENYCA™ (pegfilgrastim-cbqv), biosimilar candidate to Neulasta
CHS-1420 (adalimumab (Humira®) biosimilar)
CHS-3351 (ranibizumab (Lucentis®) biosimilar) and CHS-2020 (aflibercept (Eylea®) biosimilar)
Conference Call Information
When: Wednesday, August 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 4562488
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.
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 & marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, UDENYCA™ (pegfilgrastim-cbqv), CHS-1420 (adalimumab biosimilar) and CHS-0214 (etanercept biosimilar), as well as developing a robust pipeline of future products in ophthalmology (including CHS-3351, a ranibizumab biosimilar, and CHS-2020, an aflibercept biosimilar), as well as 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’ expectations regarding the FDA’s action date; Coherus’ expectations regarding regulatory approval for UDENYCA™ from the European Commission; Coherus’ ability to enter into commercial collaborations in ex-U.S. territories; Coherus’ plan to initiate U.S. commercial launch for UDENYCA™; Coherus’ plan to initiate the clinical development of CHS-3351; Coherus’ expectation to continue the preclinical development of CHS-2020; Coherus’ ability to pursue manufacturing objectives of CHS-1420 in support of a BLA; Coherus’ plan to continue to develop partnering options of CHS-1420 for ex-US territories; and Coherus’ ability to anticipate cash use for the third quarter of 2018. 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, 2018, filed with the Securities and Exchange Commission on August 8, 2018 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended June 30, 2018 are not necessarily indicative of our operating results for any future periods.
UDENYCA™ is a trademark of Coherus BioSciences, Inc.
Enbrel® and Neulasta® 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||Six Months Ended|
|June 30,||June 30,|
|Collaboration and license revenue||$||-||$||1,395||$||-||$||1,556|
|Research and development||26,519||34,500||51,974||88,275|
|General and administrative||18,391||23,533||34,968||42,336|
|Total operating expenses||44,910||58,033||86,942||130,611|
|Loss from operations||(44,910||)||(56,638||)||(86,942||)||(129,055||)|
|Other income, net||3,642||3,620||3,780||3,591|
|Net loss attributable to non-controlling interest||47||66||52||110|
|Net loss attributable to Coherus||$||(43,638||)||$||(55,336||)||$||(87,935||)||$||(130,114||)|
|Net loss per share attributable to Coherus, basic and diluted||$||(0.68||)||$||(1.08||)||$||(1.42||)||$||(2.60||)|
|Weighted-average number of shares used in computing net
loss per share attributable to Coherus, basic and diluted
|Coherus BioSciences, Inc.|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Cash and cash equivalents||$||130,005||$||126,911|
|Investments in marketable securities - short-term||29,813||-|
|Liabilities and Stockholders’ Equity|
|Convertible notes-related parties||25,583||25,402|
|Total stockholders' equity||61,831||30,535|
|Total liabilities and stockholders’ equity||$||188,313||$||162,611|
Chief Financial Officer
Coherus BioSciences, Inc.
+1 (650) 649-3546