Release Details
Coherus BioSciences Reports Third Quarter 2015 Financial and Operating Results and Corporate Events
Highlights include:
- CHS-0214 (etanercept (Enbrel®) biosimilar): Coherus and
Baxalta announced today that CHS-0214 met its primary efficacy endpoints in its phase 3 psoriasis clinical study. - CHS-1701 (pegfilgrastim (Neulasta®) biosimilar): On
October 1, 2015 , Coherus announced topline results of its pivotal pharmacokinetic (PK) and pharmacodynamic (PD) study, which supports our plan to file a 351(k) biologics license application (BLA) in the first quarter of 2016. In addition, Coherus completed the enrollment of additional healthy volunteers in the immunogenicity study pursuant to this BLA. - CHS-1420 (adalimumab (Humira®) biosimilar): In
August 2015 , Coherus initiated dosing of the Phase 3 study in psoriasis. Coherus anticipates initiating the PK bioequivalence bridging study by the end of the first half of 2016 with Phase 3 drug material and filing a BLA in the U.S. in the second half of 2016. - In
September 2015 , Coherus entered into and consummated a stock purchase agreement withBaxalta Incorporated ,Baxalta US Inc. andBaxalta GmbH (together, “Baxalta”). Pursuant to this agreement, Coherus sold toBaxalta an aggregate of 390,167 shares of common stock for aggregate gross proceeds of approximately$10.0 million . - On October 15, 2015, Coherus received a
$30.0 million milestone payment fromBaxalta US Inc. , pursuant to its August 30, 2013 license agreement, as amended. The milestone payment related to the successful demonstration of drug product stability for CHS-0214, its etanercept biosimilar candidate. - Coherus today, pursuant to 35 U.S.C. §§ 311–319 AND 37 C.F.R. § 42, filed in
the United States Patent and Trademark Office a petition for Inter Partes Review (“IPR”) of AbbVie’s United States Patent No. 8,889,135 entitled “Methods of Administering Anti-TNFα antibodies” directed to treating rheumatoid arthritis in a human subject via administration, every 13-15 days, of 40 mg of a human anti-TNFα antibody that includes or encompasses adalimumab.
“Coherus continued to make significant progress on all its late-stage product candidates,” said
Third Quarter 2015 Financial Results
Total revenue for the third quarter 2015 was
Research and development (R&D) expenses for the third quarter 2015 were
General and administrative (G&A) expenses for the third quarter 2015 were
Net loss attributable to Coherus for the third quarter 2015 was
Cash and cash equivalents totaled
Anticipated Near Term Milestones
- CHS-1701 (pegfilgrastim biosimilar): File 351(k) BLA in the U.S. in the first quarter of 2016; expect to finalize commercialization strategy in the first half of 2016.
- CHS-1420 (adalimumab biosimilar): Initiate PK bioequivalence bridging study by the end of the first half of 2016 with Phase 3 drug material; file BLA in the U.S. in the second half of 2016.
- CHS-0214 (etanercept biosimilar): Expect to initiate additional studies in mid-2016 to provide comparative PK data on the CHS-0214 drug material used in the Phase 3 studies, the CHS-0214 drug material intended for commercial use, and Enbrel manufactured in
Europe ; expect to file a Marketing Authorization Application (MAA) in the E.U. in late 2016.
Conference Call Information
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About
Coherus is a leading pure-play 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. 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’ expectations regarding its ability to advance its CHS-1701, CHS-0214 and CHS-1420 biosimilar drug candidates, and initiate and complete the PK bioequivalence bridging study for CHS-1420, complete its BLA-enabling studies for CHS-1701, file BLAs for CHS-1701 and CHS-1420 in the U.S., file an MAA for CHS-0214 in the E.U., obtain any favorable outcome in connection with its petition for IPR, and receive milestone payments under its collaboration agreement with
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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Revenue: | ||||||||||||||||
Collaboration and license revenue | $ | 7,167 | $ | 15,620 | $ | 19,843 | $ | 23,168 | ||||||||
Collaboration and license revenue - related party (1) | — | 432 | — | 1,445 | ||||||||||||
Total revenue | 7,167 | 16,052 | 19,843 | 24,613 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 68,218 | 18,496 | 161,629 | 51,357 | ||||||||||||
General and administrative | 10,166 | 3,979 | 25,074 | 11,378 | ||||||||||||
Total operating expenses | 78,384 | 22,475 | 186,703 | 62,735 | ||||||||||||
Loss from operations | (71,217 | ) | (6,423 | ) | (166,860 | ) | (38,122 | ) | ||||||||
Interest expense | (33 | ) | (1 | ) | (33 | ) | (3,900 | ) | ||||||||
Other expense, net | (235 | ) | (1,490 | ) | (4,465 | ) | (16,132 | ) | ||||||||
Net loss | (71,485 | ) | (7,914 | ) | (171,358 | ) | (58,154 | ) | ||||||||
Net loss attributable to non-controlling interest | 151 | 42 | 489 | 155 | ||||||||||||
Net loss attributable to Coherus | $ | (71,334 | ) | $ | (7,872 | ) | $ | (170,869 | ) | $ | (57,999 | ) | ||||
Net loss per share attributable to Coherus, basic and diluted | $ | (1.86 | ) | $ | (1.79 | ) | $ | (4.68 | ) | $ | (13.62 | ) | ||||
Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted |
38,426,734 | 4,409,703 | 36,510,756 | 4,258,770 | ||||||||||||
(1) Represent revenue from Daiichi Sankyo Company, a holder of more than 10% of our common stock until the closing of our initial public offering on November 12, 2014. | ||||||||||||||||
Coherus BioSciences, Inc. | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(in thousands) | ||||||||
September 30, | December 31, | |||||||
2015 | 2014 | |||||||
(unaudited) | ||||||||
Assets | ||||||||
Cash and cash equivalents | $ | 153,691 | $ | 150,392 | ||||
Other assets | 48,621 | 36,829 | ||||||
Total assets | $ | 202,312 | $ | 187,221 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Deferred revenue | 62,295 | 62,699 | ||||||
Other liabilities | 99,977 | 57,765 | ||||||
Total stockholders' equity | 40,040 | 66,757 | ||||||
Total liabilities and stockholders’ equity | $ | 202,312 | $ | 187,221 | ||||
Keith Vendola , M.D. Investor RelationsCoherus BioSciences, Inc. kvendola@coherus.com +1 (650) 437-6239