Release Details
Coherus BioSciences Reports Third Quarter 2017 Operating and Financial Results
Corporate Highlights for the Third Quarter 2017 Include:
Immunology (anti-TNF) therapeutic franchise:
- CHS-0214 (etanercept (Enbrel®) biosimilar candidate)
- Filed petitions for Inter Partes Review (“IPR”) inthe United States Patent and Trademark Office seeking invalidation of U.S. Patents 8,163,522 (“ ‘522 patent”) and 8,063,182,
- (“ ’182 patent”). Both are generally directed to the etanercept protein, the pharmaceutically active component of Enbrel
- We expect the PTAB to enter decisions on whether to institute these two IPRs byMarch 13, 2018 (for the ’522 patent) and byMarch 26, 2018 (for the ‘182 patent). - CHS-1420 (adalimumab (Humira®) biosimilar candidate)
- Reported topline results from a pharmacokinetic bioequivalence (“PK BE”) study comparing CHS-1420 to European marketed Humira. The study met the criteria for clinical PK BE on all prospectively defined endpoints and there were no clinically meaningful differences in the safety profile between the two products.
Financial Highlights for the Third Quarter and year-to-date 2017
- Cash used in operations was
$41.5 million in the third quarter, down 25% from the$55.6 million used in the second quarter of 2017 and down 43% from the$73.3 million used in the first quarter of 2017. InAugust 2017 , we announced thatTemasek , an investment company headquartered inSingapore , plans to invest up to$150 million over two tranches. We received the first tranche of$75 million in aggregate proceeds onAugust 24, 2017 and issued 6,556,116 shares of common stock at an offer price of$11.4397 per share. The second tranche is projected to be funded following receipt of the U.S. Food and Drug Administration’s marketing approval for the CHS-1701 pegfilgrastim biosimilar product candidate, subject to market pricing and certain closing conditions at that time, including each party’s final approval. - Research and development (R&D) expenses for the third quarter of 2017 were
$42.6 million , as compared to$64.6 million for the same period in 2016. R&D expenses for the nine months endedSeptember 30, 2017 were$130.9 million , as compared to$195.4 million for the same period in 2016. Decreases in R&D expenses were mainly attributable to the decline and end of clinical activities for CHS-0214, CHS-1420 and CHS-131 during the preceding twelve months. - General and administrative (G&A) expenses for the third quarter of 2017 were
$14.0 million , as compared to$13.6 million for the same period in 2016. G&A expenses for the nine months endedSeptember 30, 2017 were$56.3 million , as compared to$36.3 million for the same period in 2016. Changes in G&A expenses were mainly attributable to legal and other professional fees to support intellectual property litigation and IPRs, as well as personnel related costs to support CHS-1701 pre-commercial activities in the first six months of 2017. - Net loss attributable to Coherus for the third quarter of 2017 was
($59.0) million , or($1.09) per share, as compared to net income attributable to Coherus of$83.9 million , or$1.67 per share, for the same period in 2016. - Cash, cash equivalents and investments in marketable securities – short term totaled
$150.1 million as ofSeptember 30, 2017 , as compared to$118.3 million as ofJune 30 , 2017.
Guidance for the fourth quarter of 2017 and first half of 2018:
CHS-1701 (pegfilgrastim (Neulasta®) biosimilar)
- Anticipate resubmitting the BLA in the U.S. mid-first quarter of 2018 subject to meeting with
FDA . - Anticipate European opinion in the first half of 2018, such timing being dependent upon data requests.
- Commercial partnering discussions continue to be underway for certain ex-U.S. territories.
CHS-3351 (ranibizumab (Lucentis®) biosimilar)
- Prioritizing the development of CHS-3351.
CHS-1420 (adalimumab biosimilar)
- Continue to optimize manufacturing.
CHS-0214 (etanercept biosimilar)
- Focus on regulatory issues through the first half of 2018.
- Provide revised guidance on filing of the marketing authorization application in
Europe after
CHS-1701 U.S. BLA resubmission. - Continue to optimize manufacturing.
- Targeting immunology (anti-TNF) partnering therapeutic franchise agreement.
CHS-131 central nervous system anti-inflammatory asset
- Completing additional animal studies on CHS-131 to further validate its mechanism of action and address drug-derived metabolites. Licensing agreement to follow subject to results.
Cash flow
- Anticipate cash use in operations of approximately
$35 - $40 million in the fourth quarter of 2017, down approximately$5 million from previous guidance, and$30 - $35 million per quarter in the first half of 2018.
Conference Call Information
When:
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 99333721
Webcast: http://investors.coherus.com
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.
About
Coherus is a leading pure-play, global 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, CHS-1701 (pegfilgrastim biosimilar), CHS-1420 (adalimumab biosimilar), CHS-0214 (etanercept biosimilar), and CHS-3351 (ranibizumab biosimilar) as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. 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, including statements regarding Coherus’ plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, preclinical and clinical studies, product development, release of data and the potential benefits of its products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including Coherus’ ability to resubmit a BLA in the US and receive marketing approval in
Enbrel® and Neulasta® are registered trademarks of
Humira® is a registered trademark of
Lucentis® is a registered trademark of
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, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Revenue: | ||||||||||||||||
Collaboration and license revenue | $ | - | $ | 162,835 | $ | 1,556 | $ | 189,262 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 42,626 | 64,573 | 130,901 | 195,430 | ||||||||||||
General and administrative | 13,989 | 13,645 | 56,325 | 36,303 | ||||||||||||
Total operating expenses | 56,615 | 78,218 | 187,226 | 231,733 | ||||||||||||
Income (loss) from operations | (56,615 | ) | 84,617 | (185,670 | ) | (42,471 | ) | |||||||||
Interest expense | (2,392 | ) | (2,420 | ) | (7,152 | ) | (5,611 | ) | ||||||||
Other income (expense), net | 14 | 1,647 | 3,605 | (3,762 | ) | |||||||||||
Net income (loss) | (58,993 | ) | 83,844 | (189,217 | ) | (51,844 | ) | |||||||||
Net loss attributable to non-controlling interest | 4 | 95 | 114 | 428 | ||||||||||||
Net income (loss) attributable to Coherus | $ | (58,989 | ) | $ | 83,939 | $ | (189,103 | ) | $ | (51,416 | ) | |||||
Net income (loss) per share attributable to Coherus | ||||||||||||||||
Basic | $ | (1.09 | ) | $ | 1.93 | $ | (3.68 | ) | $ | (1.25 | ) | |||||
Diluted | $ | (1.09 | ) | $ | 1.67 | $ | (3.68 | ) | $ | (1.25 | ) | |||||
Weighted-average number of shares used in computing net income (loss) per share attributable to Coherus |
||||||||||||||||
Basic | 54,070,872 | 43,469,986 | 51,377,836 | 41,096,783 | ||||||||||||
Diluted | 54,070,872 | 51,581,298 | 51,377,836 | 41,096,783 | ||||||||||||
Coherus BioSciences, Inc. | ||||||
Condensed Consolidated Balance Sheets | ||||||
(in thousands) | ||||||
September 30, | December 31, | |||||
2017 | 2016 | |||||
(unaudited) | ||||||
Assets | ||||||
Cash and cash equivalents | $ | 135,557 | $ | 124,947 | ||
Investments in marketable securities - short-term | 14,493 | - | ||||
Other assets | 39,708 | 53,538 | ||||
Total assets | $ | 189,758 | $ | 178,485 | ||
Liabilities and Stockholders’ Equity | ||||||
Deferred revenue | $ | - | $ | 1,561 | ||
Convertible notes | 75,944 | 75,192 | ||||
Convertible notes-related parties | 25,314 | 25,064 | ||||
Other liabilities | 33,593 | 57,314 | ||||
Total stockholders' equity | 54,907 | 19,354 | ||||
Total liabilities and stockholders’ equity | $ | 189,758 | $ | 178,485 | ||
CONTACT:
Patrick O’Brien
Senior Vice President, Investor Relations
pobrien@coherus.com
+1 (650) 649-3527