Full Press Release Details
Coherus BioSciences Reports Fourth Quarter and Full Year 2018 Financial Results
REDWOOD CITY, Calif., February 28, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), today reviewed corporate events and reported financial results
for the quarter and full year ended December 31, 2018.
Fourth Quarter 2018 and Recent Corporate Highlights Include:
Fourth Quarter and Full Year 2018 Financial Results:
Research and development (R&D) expenses for the fourth quarter of 2018 were $26.7 million, as compared to $31.5 million for the same
period in 2017. R&D expenses for the fiscal year 2018 were $110.2 million, as compared to $162.4 million for the same period in 2017. The decreases in R&D expenses were mainly due to the completion of the clinical trials
and related manufacturing for the immunology biosimilar drug candidates, CHS-0214 (etanercept (Enbrel ) biosimilar) and
CHS-1420. These cost decreases were partially offset by increased costs associated with the manufacturing of UDENYCA . Coherus had approximately 330,000 cumulative units of UDENYCA released as of
Selling, general and administrative (SG&A) expenses for the fourth quarter of 2018 were $33.8 million, as
compared to $15.0 million for the same period in 2017. SG&A expenses for the fiscal year 2018 were $94.2 million, as compared to $71.3 million for the same period in 2017. The increases in SG&A expenses in 2018 were
mainly attributable to the costs associated with hiring a sales force and completing the commercial functions and infrastructure to launch and sell UDENYCA in the U.S.
Cash and cash equivalents and investments in marketable securities for the fourth quarter totaled $72.4 million as of December 31, 2018,
before receiving $73.1 million in net proceeds from the senior secured credit facility in January 2019, or a pro forma total of $145.5 million, as compared to $117.2 million as of September 30, 2018. Cash used in operations
was $47.4 million during the fourth quarter of 2018, as compared to $42.8 million during the third quarter of 2018.
attributable to Coherus for the fourth quarter of 2018 was ($62.6) million, or ($0.92) per share, compared to a net loss of ($49.1) million, or ($0.84) per share, for the same period in 2017. Net loss attributable to Coherus
for 2018 was ($209.3) million, or ($3.22) per share, compared to a net loss of ($238.2) million, or ($4.48) per share, for 2017.
Guidance for the Next Twelve Months from December 31, 2018:
UDENYCA (pegfilgrastim-cbqv), Neulasta (pegfilgrastim) biosimilar
CHS-1420 (adalimumab (Humira ) biosimilar)
CHS-3351 (ranibizumab (Lucentis ) biosimilar) and CHS-2020 (aflibercept (Eylea ) biosimilar)
Conference Call Information
February 28, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826
(toll free) or (765) 507-2587 (International)
Conference ID: 3398069
Webcast: http://investors.coherus.com
conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.
Fourth quarter and full year 2018 financial
results, are posted on the Coherus website at http://investors.coherus.com.
About Coherus BioSciences, Inc.
Coherus BioSciences is a leading 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 and marketing and clinical-regulatory development, Coherus BioSciences is positioned as a leader in the global biosimilar marketplace. Coherus BioSciences
commercializes UDENYCA (pegfilgrastim-cbqv) in the U.S. and has received regulatory approval for UDENYCA in the European Union. Coherus BioSciences is advancing two late-stage clinical products towards commercialization, CHS-1420 (adalimumab biosimilar) and CHS-0214 (etanercept biosimilar), and developing a robust pipeline of future products in ophthalmology (including CHS-3351, a ranibizumab biosimilar, and CHS-2020, an aflibercept biosimilar), as well as CHS-131, a small molecule for nonalcoholic
steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit www.coherus.com.
UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile
neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance
manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.
UDENYCA is a leukocyte growth
factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a
clinically significant incidence of febrile neutropenia.
UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
IMPORTANT SAFETY INFORMATION
Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.
WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS: Most common adverse reactions ( 5% difference in incidence compared to placebo) are bone pain and pain in extremity.
ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA
(1-800-483-3692) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Full Prescribing Information available at www.UDENYCA.com
Forward-Looking Statements
Except for the historical
information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited
to, Coherus expectations regarding commercial sales of UDENYCA in the U.S., its reimbursement status and its ability to increase penetration of patient
and provider support programs and access portals; Coherus ability to pursue manufacturing objectives of CHS-1420 in support of a BLA; Coherus
plan to complete manufacturing technology transfer to support clinical and continued preclinical development of CHS-3351. Such forward-looking statements involve substantial risks and uncertainties that could
cause Coherus actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others,
the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus regulatory filings; the risk that Coherus is unable to complete
commercial transactions and other matters that could affect the availability or commercial potential of Coherus biosimilar drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained
in this press release speak only as of the date on which they were made. 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, 2018, filed with the Securities and Exchange Commission on February 28, 2019 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter and year ended December 31,
2018 are not necessarily indicative of our operating results for any future periods.
UDENYCA is a trademark of Coherus BioSciences, Inc.
Enbrel and Neulasta are registered
trademarks of Amgen Inc.
Humira is a registered trademark of AbbVie Inc.
Lucentis is a registered trademark of Genentech, Inc.
Eylea is a registered trademark of Regeneron Pharmaceuticals, Inc.
Coherus BioSciences, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| (unaudited) | ||||||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration and license revenue | $ | $ | $ | $ | 1,556 | |||||||||||
| Total revenue | 1,556 | |||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 26,662 | 31,488 | 110,239 | 162,389 | ||||||||||||
| Selling, general and administrative | 33,840 | 14,978 | 94,177 | 71,303 | ||||||||||||
| Total operating expenses | 60,502 | 46,466 | 204,416 | 233,692 | ||||||||||||
| Loss from operations | (60,502 | ) | (46,466 | ) | (204,416 | ) | (232,136 | ) | ||||||||
| Interest expense | (2,434 | ) | (2,400 | ) | (9,684 | ) | (9,552 | ) | ||||||||
| Other income (expense), net | 340 | (203 | ) | 4,691 | 3,402 | |||||||||||
| Net loss | (62,596 | ) | (49,069 | ) | (209,409 | ) | (238,286 | ) | ||||||||
| Net loss attributable to non-controlling interest | 2 | 70 | 116 | |||||||||||||
| Net loss attributable to Coherus | $ | (62,596 | ) | $ | (49,067 | ) | $ | (209,339 | ) | $ | (238,170 | ) | ||||
| Net loss per share attributable to Coherus, basic and diluted | $ | (0.92 | ) | $ | (0.84 | ) | $ | (3.22 | ) | $ | (4.48 | ) | ||||
| Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted | 68,089,486 | 58,343,720 | 65,034,827 | 53,133,620 |
Coherus BioSciences, Inc.
Condensed Consolidated Balance Sheets
| December 31, 2018 | December 31, 2017 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 72,356 | $ | 126,911 | ||||
| Other assets | 27,111 | 35,700 | ||||||
| Total assets | $ | 99,467 | $ | 162,611 | ||||
| Liabilities and Stockholders Equity (deficit) | ||||||||
| Convertible notes | $ | 77,319 | $ | 76,206 | ||||
| Convertible notes-related parties | 25,773 | 25,204 | ||||||
| Other liabilities | 34,966 | 30,666 | ||||||
| Total stockholders equity (deficit) | (38,591 | ) | 30,535 | |||||
| Total liabilities and stockholders equity (deficit) | $ | 99,467 | $ | 162,611 |
Vice President, Investor Relations & Corporate Affairs
Coherus BioSciences, Inc.