Full Press Release Details
Coherus BioSciences Reports First Quarter 2016
Financial and Operating Results
CHS-1420 (adalimumab biosimilar) Formulation Patents to Issue in May
Completed Private Convertible Financing of $100 million
Received $30 million Milestone Payment from Baxalta in May
REDWOOD CITY, Calif., May 9, 2016 Coherus BioSciences, Inc. (Nasdaq: CHRS), a leading pure-play, global biosimilars company with late-stage clinical,
as well as pipeline products, today reported financial results and reviewed corporate events for the quarter ended March 31, 2016.
We continue to have strong execution on all three late-stage programs with the lead-up to
registrational submissions. In early 2016, we announced positive data in BLA-enabling and Phase 3 trials for CHS-1701 and CHS-0214 respectively, enhanced our cash position with $100 million from the proceeds of senior convertible notes, and
organized our pipeline into four therapeutic area franchises: oncology, immunology, ophthalmology and multiple sclerosis, said Denny Lanfear, President and Chief Executive Officer of Coherus. In addition, we continue to advance our
adalimumab IP strategy with our IPR filing against AbbVie s 166 formulation patent, and receipt from the U.S. Patent Office of notification that three Coherus U.S. patents on adalimumab formulations will issue this month.
First Quarter 2016 Financial Results
revenue for the first quarter 2016 was $12.4 million, as compared to $5.8 million in the first quarter of 2015. The increase over the same period in 2015 was due to increased recognition in Baxalta collaboration revenue as a result of
receiving three development milestone payments totaling $100.0 million in 2015.
Research and development (R&D) expenses for the first quarter
2016 were $65.3 million compared to $36.5 million for the same period in 2015. Increases in R&D expenses were mainly attributable to having four on-going Phase 3 and BLA enabling studies for CHS-0214, CHS-1420 and CHS-1701 in 2016 compared
to just two late-stage studies that were on-going in 2015, proceeding with preclinical activities associated with our early-stage pipeline, and hiring additional personnel to support late-development and early-stage activities.
General and administrative (G&A) expenses for the first quarter 2016 were $11.4 million, compared to $6.1 million for the same period in
2015. Changes in G&A expenses were mainly attributable to hiring employees to support legal, pre-commercial and accounting activities, legal fees to support the intellectual property strategy, and accounting fees and services related to
compliance with Section 404 of the Sarbanes-Oxley Act of 2002.
Net loss attributable to Coherus for the first quarter of 2016 was $65.4
million, or $1.67 per share, compared to $40.7 million, or $1.22 per share, for the same period in 2015.
Cash and cash equivalents totaled $179.6
million as of March 31, 2016, compared to $158.2 million as of December 31, 2015.
This past quarter represents the high point of R&D spending in 2016, and we project a
quarter-to-quarter decline in R&D spending for the rest of the year as we complete various registration enabling efforts, said Jean Viret, Ph.D., Chief Financial Officer. While this investment in our product registrations is
essential for commercialization, we remain tightly focused on spending control in all areas.
When: Monday, May 9, 2016 at 1:30 p.m. PT
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 2374783
Webcast: http://investors.coherus.com
the conference call at least 10 minutes early to register.
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, including CHS-5217 (bevacizumab
biosimilar) and CHS-3351 (ranibizumab biosimilar). 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, CHS-1420, CHS-5217 and
CHS-3351 biosimilar drug candidates, complete bridging studies for CHS-0214, complete its follow-on PK/PD study 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., file one IND on a second wave
biosimilar pipeline candidate, enter into collaborations for CHS-1701 commercialization ex-U.S. and advance its intellectual strategy for CHS-1420 including with respect to the issuance to Coherus of three U.S. patents on adalimumab formulations.
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 Annual Report on Form 10-K for the
year ended December 31, 2015, filed with the Securities and Exchange Commission on February 29, 2016 and its future periodic reports to be filed with the Securities and Exchange Commission.
Enbrel and Neulasta are registered
trademarks of Amgen Inc.
HUMIRA is a registered trademark of AbbVie Inc.
Avastin and Lucentis are registered
trademarks of Genentech, Inc.
Coherus BioSciences, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| (unaudited) | ||||||||
| Revenue: | ||||||||
| Collaboration and license revenue | $ | 12,359 | $ | 5,810 | ||||
| Total revenue | 12,359 | 5,810 | ||||||
| Operating expenses: | ||||||||
| Research and development | 65,313 | 36,467 | ||||||
| General and administrative | 11,398 | 6,091 | ||||||
| Total operating expenses | 76,711 | 42,558 | ||||||
| Loss from operations | (64,352 | ) | (36,748 | ) | ||||
| Interest expense | (837 | ) | ||||||
| Other expense, net | (349 | ) | (4,091 | ) | ||||
| Net loss | (65,538 | ) | (40,839 | ) | ||||
| Net loss attributable to non-controlling interest | 150 | 114 | ||||||
| Net loss attributable to Coherus | $ | (65,388 | ) | $ | (40,725 | ) | ||
| Net loss per share attributable to Coherus, basic and diluted | $ | (1.67 | ) | $ | (1.22 | ) | ||
| Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted | 39,095,975 | 33,377,298 |
Coherus BioSciences, Inc.
Condensed Consolidated Balance Sheets
| March 31, 2016 | December 31, 2015 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 179,558 | $ | 158,226 | ||||
| Other assets | 46,678 | 54,158 | ||||||
| Total assets | $ | 226,236 | $ | 212,384 | ||||
| Liabilities and Stockholders Deficit | ||||||||
| Deferred revenue | 82,606 | 94,959 | ||||||
| Other liabilities | 210,508 | 124,354 | ||||||
| Total stockholders deficit | (66,878 | ) | (6,929 | ) | ||||
| Total liabilities and stockholders deficit | $ | 226,236 | $ | 212,384 |
Coherus BioSciences, Inc.