Release Details
Coherus BioSciences Reports Second Quarter 2016 Financial and Operating Results
Corporate Highlights for the Second Quarter 2016 Include:
- Immunology (anti-TNF) therapeutic franchise:
- CHS-1420 (adalimumab (HUMIRA®) biosimilar)
- Received favorable decision from the
Patent Trial and Review Board (PTAB) for the United States Patent and Trademark Office (USPTO) instituting Coherus' petition for Inter Partes Review (IPR) of AbbVie’s U.S. patent 8,889,135 (“the ‘135 patent”), 9,017,680 and 9,073,987 (patents ‘680 and ‘987, respectively), which are all related to the dosing regimen for AbbVie’s Humira (adalimumab) to treat rheumatoid arthritis. - Issued patents from the USPTO for U.S. patents 9,340,611; 9,340,612 and 9,346,880 generally concerning the formulations of adalimumab, the active biologic ingredient in Coherus’ Humira biosimilar.
- Received favorable decision from the
- CHS-0214 (etanercept (Enbrel®) biosimilar)
- Completed enrollment on two Phase 1 bridging studies.
- CHS-1420 (adalimumab (HUMIRA®) biosimilar)
- Multiple sclerosis therapeutic franchise:
- CHS-131 (new chemical entity therapeutic)
- Reported a positive Phase 2b randomized, double-blind, placebo-controlled clinical study.
- Demonstrated approximately a 50 percent statistically significant decrease in the incidence of new contrast-enhancing lesions over six months when compared to placebo.
- CHS-131 (new chemical entity therapeutic)
Financial highlights for the Second Quarter 2016 include:
- Announced the pricing of an underwritten public offering totaling 4,025,000 shares of its common stock at a price to the public of $18.00 per share before deducting the underwriting discount, resulting in
$69.0 million to Coherus net of all fees. All of the shares of the common stock sold in the offering were offered by Coherus. - Received
$30.0 million milestone payment from Baxalta related to the last patient, last visit in the global CHS-0214 Phase 3 trials.
Second Quarter and year-to-date 2016 Financial Results
Total revenue for the second quarter of 2016 was
Research and development (R&D) expenses for the second quarter of 2016 were
General and administrative (G&A) expenses for the second quarter of 2016 were
Net loss attributable to Coherus for the second quarter of 2016 was
Cash and cash equivalents totaled
Guidance for the Second Half of 2016:
- Oncology therapeutic franchise:
- CHS-1701 (pegfilgrastim (Neulasta®) biosimilar)
- Reported in July positive follow-on pharmacokinetic/pharmacodynamic (PK/PD) study.
- Initiate commercial partnering discussions for certain ex-U.S. territories.
- Anticipated submission of Marketing Authorization Application (MAA) in the fourth quarter.
- CHS-1701 (pegfilgrastim (Neulasta®) biosimilar)
- Immunology (anti-TNF) therapeutic franchise:
- CHS-0214 (etanercept biosimilar)
- Complete two Phase 1 bridging studies.
- Expect MAA acceptance in conjunction with partner Baxalta (now part of Shire) in late 2016.
- CHS-1420 (adalimumab biosimilar)
- Reported in August positive interim Phase 3 clinical trial in psoriasis at 16-weeks.
- Complete Phase 3 clinical trial in psoriasis in Q4 2016.
- Expect a 351(k) BLA acceptance in the U.S. late Q4/Q1 2017.
- Continue to advance intellectual property strategy.
- Partnering discussions for the immunology (anti-TNF) therapeutic franchise have begun, targeting an agreement in the first half of 2017.
- CHS-0214 (etanercept biosimilar)
- File one investigational new drug (IND) application for a second wave biosimilar candidate.
Conference Call Information
When:
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 46774291
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 for one year.
About
Coherus is a leading global biosimilar platform 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 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-0214 (etanercept biosimilar) and CHS-1420 (adalimumab 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, 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 initiate and complete partnering discussions and receive MAA acceptance for CHS-1701, complete bridging studies and MAA acceptance for CHS-0214, complete trials and receive BLA acceptance, and complete a partnering agreement for CHS-1420. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. 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 quarter ended
Enbrel® and Neulasta® are registered trademarks of
HUMIRA® 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, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Revenue: | ||||||||||||||||
Collaboration and license revenue | $ | 14,068 | $ | 6,866 | $ | 26,427 | $ | 12,676 | ||||||||
Total revenue | 14,068 | 6,866 | 26,427 | 12,676 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 65,544 | 56,944 | 130,857 | 93,411 | ||||||||||||
General and administrative | 11,260 | 8,817 | 22,658 | 14,908 | ||||||||||||
Total operating expenses | 76,804 | 65,761 | 153,515 | 108,319 | ||||||||||||
Loss from operations | (62,736 | ) | (58,895 | ) | (127,088 | ) | (95,643 | ) | ||||||||
Interest expense | (2,354 | ) | — | (3,191 | ) | — | ||||||||||
Other expense, net | (5,060 | ) | (139 | ) | (5,409 | ) | (4,230 | ) | ||||||||
Net loss | (70,150 | ) | (59,034 | ) | (135,688 | ) | (99,873 | ) | ||||||||
Net loss attributable to non-controlling interest | 183 | 224 | 333 | 338 | ||||||||||||
Net loss attributable to Coherus | $ | (69,967 | ) | $ | (58,810 | ) | $ | (135,355 | ) | $ | (99,535 | ) | ||||
Net loss per share attributable to Coherus, basic and diluted | $ | (1.72 | ) | $ | (1.56 | ) | $ | (3.39 | ) | $ | (2.80 | ) | ||||
Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted | 40,698,309 | 37,672,748 | 39,897,142 | 35,536,889 | ||||||||||||
Coherus BioSciences, Inc. | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(in thousands) | ||||||||
June 30, | December 31, | |||||||
2016 | 2015 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Cash and cash equivalents | $ | 220,916 | $ | 158,226 | ||||
Other assets | 30,185 | 54,158 | ||||||
Total assets | $ | 251,101 | $ | 212,384 | ||||
Liabilities and Stockholders’ Deficit | ||||||||
Deferred revenue | 88,050 | 94,959 | ||||||
Convertible notes | 99,627 | — | ||||||
Other liabilities | 125,372 | 124,354 | ||||||
Total stockholders' deficit | (61,948 | ) | (6,929 | ) | ||||
Total liabilities and stockholders’ deficit | $ | 251,101 | $ | 212,384 | ||||
CONTACT:Patrick O’Brien Senior Vice President, Investor RelationsCoherus BioSciences, Inc. pobrien@coherus.com +1 (650) 649-3527