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Coherus BioSciences Reports Corporate Highlights and Second Quarter 2018 Financial Results
Second Quarter 2018 Corporate Highlights Include:
- UDENYCA™ (pegfilgrastim-cbqv), biosimilar candidate to Neulasta®
• 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
May 10, 2018, Coherus announced the appointment of Samuel Nussbaum, M.D. to its Board of Directors. From 2000 until 2016, Dr. Nussbaum served as Executive Vice President, Clinical Health Policy, and Chief Medical Officer for Anthem. In that role, he was the key spokesperson and policy advocate and oversaw clinical strategy and corporate medical and pharmacy policy. He currently serves as a Strategic Consultant to EBG Advisors, consulting arm for Epstein Becker and Green, where he advises life science companies, health care systems and provider organizations.
May 2018, Coherus completed an underwritten public offering of 5,948,274 shares of its common stock at a price to the public of $14.50per share, which includes the closing of the full exercise of the underwriters’ option to purchase an additional 775,861 shares of common stock. Coherus received net proceeds of $80.8 millionfrom the offering.
Second Quarter 2018 Financial Results:
- Research and development (R&D) expenses for the second quarter of 2018 were
$26.5 millioncompared to $34.5 millionfor the same period in 2017. R&D expenses for the six months ended June 30, 2018were $52.0 million, as compared to $88.3 millionfor the same period in 2017. The decreases in R&D expenses were mainly due to the completion of our clinical trials for the immunology biosimilar drug candidates, CHS-1420 (adalimumab (Humira®) biosimilar) and CHS-0214 (etanercept (Enbrel®) biosimilar), and the reprioritization of resources to advance UDENYCA™.
- General and administrative (G&A) expenses for the second quarter of 2018 were
$18.4 million, compared to $23.5 millionfor the same period in 2017. G&A expenses for the six months ended June 30, 2018were $35.0 million, as compared to $42.3 millionfor the same period in 2017. The decreases in G&A expenses in 2018 were mainly attributable to a decrease in personnel and in certain legal and consulting services as a result of cost control steps taken since June 2017.
- Net loss attributable to Coherus for the second quarter of 2018 was
($43.6) million, or ($0.68)per share, compared to a net loss of ($55.3) million, or ($1.08)per share, for the same period in 2017.
- Cash and cash equivalents and investments in marketable securities – totaled
$159.8 millionas of June 30, 2018, compared to $95.2 millionas of March 31, 2018.
Guidance for 2018:
UDENYCA™ (pegfilgrastim-cbqv), biosimilar candidate to Neulasta
FDAaction date is set for November 3, 2018.
- Anticipate regulatory approval for UDENYCA™ from the
European Commissionon or before October 1, 2018.
- Commercial partnering discussions are projected to continue for certain ex-U.S. territories.
- Anticipate U.S. commercial launch directly following the
FDAaction date, dependent on regulatory review and approval timing.
CHS-1420 (adalimumab (Humira®) biosimilar)
- Pursue manufacturing objectives in support of a BLA.
- Continue to develop partnering options for ex-U.S. territories.
CHS-3351 (ranibizumab (Lucentis®) biosimilar) and CHS-2020 (aflibercept (Eylea®) biosimilar)
- Initiate clinical development of CHS-3351.
- Continue preclinical development of CHS-2020.
- Anticipate cash use in operations of approximately
$48 to $53 millionfor the third quarter of 2018.
Conference Call Information
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.
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
UDENYCA™ is a trademark of
Enbrel® and Neulasta® are registered trademarks of
Humira® is a registered trademark of
Lucentis® is a registered trademark of
Eylea® is a registered trademark of
|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
+1 (650) 649-3546