Full Press Release Details
Coherus BioSciences Reports Third Quarter 2015
Financial and Operating Results and Corporate Events
Pegfilgrastim PK/PD Study Completed and Adalimumab Phase 3 Study Initiated
REDWOOD CITY, Calif., November 9, 2015 Coherus BioSciences, Inc. (Nasdaq: CHRS), a leading pure-play, global biosimilars company with late-stage
clinical products, today reviewed corporate events and reported financial results for the third quarter ended September 30, 2015.
continued to make significant progress on all its late-stage product candidates, said Denny Lanfear, president and chief executive officer of Coherus. We expect to file the BLA for CHS-1701 in the first quarter of 2016 and we look
forward to reporting the results of the CHS-0214 rheumatoid arthritis Phase 3 clinical study in the first quarter of 2016.
Total revenue for the third quarter 2015 was $7.2 million, as compared to $16.1 million in the third quarter of
2014. Total revenue for the nine months ended September 30, 2015 was $19.8 million, as compared to $24.6 million for the same period in 2014. The lower revenue in the third quarter and nine months ended September 30, 2015 over
the same periods in 2014 was due to the recognition of a $10.0 million substantive milestone from Baxalta earned in third quarter of 2014, in addition to the collaboration and license revenue recognized over the estimated period of the
Research and development (R&D) expenses for the third quarter 2015 were $68.2 million, compared with
$18.5 million for the same period in 2014. R&D expenses for the nine months ended September 30, 2015 were $161.6 million, as compared to $51.4 million for the same period in 2014. Increases in R&D expenses over the same periods
were mainly attributable to an increase in clinical and manufacturing costs associated with the completion of clinical trial enrollment for the CHS-0214 Phase 3 studies, the enrollment of CHS-1701 BLA-enabling studies and the initiation of CHS-1420
Phase 3 study in psoriasis.
General and administrative (G&A) expenses for the third quarter 2015 were $10.2 million, compared to $4.0 million
for the same period in 2014. G&A expenses for the nine months ended September 30, 2015 were $25.1 million, as compared to $11.4 million for the same period in 2014. Increases in G&A expenses over the same periods were mainly
attributable to increased employee-related expenses, increased legal and accounting services in support of being a public company and increased patent legal expenses related to the prosecution of patent filings.
Net loss attributable to Coherus for the third quarter 2015 was $71.3 million, or $1.86 per share, compared to $7.9 million, or $1.79 per share, for
the same period in 2014.
Cash and cash equivalents totaled $153.7 million at September 30, 2015 compared to $206.1 million as of
June 30, 2015, and $150.4 million at December 31, 2014.
Anticipated Near Term Milestones
Conference Call Information
When: November 9, 2015,
Dial-in: (844) 452-6826 (domestic) or (765) 507-2587 (international)
Conference ID: 69284641
Please join the conference call at least 10 minutes early to register.
The webcast of the conference call will be available for replay through November 24, 2015.
About Coherus BioSciences, Inc.
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 Baxalta. 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 June 30, 2015, filed with the Securities and Exchange Commission on August 10, 2015, and its
future periodic reports to be filed with the Securities and Exchange Commission.
Neulasta are registered trademarks of Amgen Inc.
HUMIRA is a registered trademark of AbbVie Inc.
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 |
Coherus BioSciences, Inc.
Condensed Consolidated Balance Sheets
| 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 |
Coherus BioSciences, Inc.