Full Press Release Details
Coherus BioSciences Reports Corporate Highlights and
First Quarter 2019 Financial Results
REDWOOD CITY, Calif., May 9, 2019 Coherus BioSciences, Inc. ( Coherus or the Company , Nasdaq: CHRS), today reviewed
corporate highlights and reported financial results for the quarter ended March 31, 2019.
First Quarter 2019 Company Highlights
First Quarter 2019 Financial Results
Guidance for the Next Nine
Months from March 31, 2019
Conference Call Information
When: Thursday, May 9,
2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765)
507-2587 (international)
Conference ID: 2969536
Webcast: http://investors.coherus.com
to register when you join the call. The webcast will be archived on the Coherus website.
(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
Most common adverse reactions ( 5% difference in incidence compared to placebo) are bone pain and pain in
To report SUSPECTED 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
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.
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, transitional pass-through status in 340B hospitals from CMS incentivizing access to UDENYCA ; being able to accelerate the manufacturing of UDENYCA ; Coherus expectations regarding its ability to increase the breadth and
depth of UDENYCA s adoption across all market segments and to secure reimbursement coverage among remaining national and regional payers for UDENYCA ; Coherus ability to pursue
manufacturing objectives of CHS-1420 in support of an anticipated BLA; Coherus plan to complete the manufacturing technology transfer to support the clinical development of
CHS-3351; Coherus expectation to continue the preclinical development of CHS-2020; and Coherus plan to initiate a clinical phase program for CHS-131 in NASH. 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 Quarterly Report on Form 10-Q for the three months ended March 31, 2019, filed with the Securities and Exchange Commission on
May 9, 2019 and its future periodic reports to be filed with the Securities and Exchange Commission. Our results for the quarter ended March 31, 2019 are not necessarily indicative of our operating results for any future periods.
UDENYCA is a trademark of Coherus BioSciences, Inc.
Neulasta is a registered trademark 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 March 31, | ||||||||
| 2019 | 2018 | |||||||
| (unaudited) | ||||||||
| Revenue: | ||||||||
| Net product revenue | $ | 37,098 | $ | |||||
| Operating expenses: | ||||||||
| Cost of goods sold | 2,225 | |||||||
| Research and development | 18,789 | 25,455 | ||||||
| Selling, general and administrative | 32,683 | 16,577 | ||||||
| Total operating expenses | 53,697 | 42,032 | ||||||
| Loss from operations | (16,599 | ) | (42,032 | ) | ||||
| Interest expense | (4,216 | ) | (2,408 | ) | ||||
| Other income, net | 811 | 138 | ||||||
| Net loss | (20,004 | ) | (44,302 | ) | ||||
| Net loss attributable to non-controlling interest | 5 | |||||||
| Net loss attributable to Coherus | $ | (20,004 | ) | $ | (44,297 | ) | ||
| Net loss per share attributable to Coherus, basic and diluted | $ | (0.29 | ) | $ | (0.74 | ) | ||
| Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted | 69,140,697 | 60,122,050 |
Coherus BioSciences, Inc.
Condensed Consolidated Balance Sheets
| March 31, 2019 | December 31, 2018 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 81,515 | $ | 72,356 | ||||
| Investments in marketable securities - short-term | 14,918 | |||||||
| Trade receivables, net | 46,476 | |||||||
| Other assets | 43,206 | 27,111 | ||||||
| Total assets | $ | 186,115 | $ | 99,467 | ||||
| Liabilities and Stockholders Deficit | ||||||||
| Convertible notes | $ | 77,614 | $ | 77,319 | ||||
| Convertible notes - related parties | 25,872 | 25,773 | ||||||
| Term loan | 73,124 | |||||||
| Other liabilities | 48,020 | 34,966 | ||||||
| Total stockholders deficit | (38,515 | ) | (38,591 | ) | ||||
| Total liabilities and stockholders deficit | $ | 186,115 | $ | 99,467 |
VP, Investor Relations & Corporate Affairs
Coherus BioSciences, Inc.