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Coherus BioSciences Reports Fourth Quarter and Year End 2015 Financial and Operating Results Completed Private Convertible Financing of $100 million Completed Positive Immunogenicity Registration Trial for CHS-1701 Compl

Key Takeaway: Coherus BioSciences Reports Fourth Quarter and Year End 2015 Financial and Operating Results Completed Private Convertible Financing of $100 million Completed Positive Immunogenicity Registration Trial for CHS-1701 Completed Two Positive Phase 3 Registration Trials for CHS-02

Full Press Release Details

Coherus BioSciences Reports Fourth Quarter and Year End 2015
Financial and Operating Results
Completed Private Convertible Financing of $100 million
Completed Positive Immunogenicity Registration Trial for CHS-1701
Completed Two Positive Phase 3 Registration Trials for CHS-0214
Announced Addition of Two Pipeline Assets
REDWOOD CITY, Calif., February 29, 2016 Coherus BioSciences, Inc. (Nasdaq: CHRS), a leading pure-play, global biosimilars company with late-stage
clinical products, today reported financial results and reviewed corporate events for the quarter and fiscal year ended December 31, 2015.
and Current Highlights
In 2015, we brought all three of our lead first wave products closer to registration and finished the year in a strong financial position with over $158
million in cash. This is now complemented with an additional $100 million from the proceeds of senior unsecured convertible notes, said Denny Lanfear, President and Chief Executive Officer of Coherus. In addition, we clearly understand
the unique market dynamics specific to different biosimilars, and the need for tailored commercial approaches. As such, we have organized our pipeline into four therapeutic area franchises: oncology, immunology, ophthalmology and multiple sclerosis.
We intend to retain the U.S. commercial rights for our oncology franchise and to seek partnerships for our other franchises.
Year-End 2015 Financial Results
Total revenue for the fourth quarter 2015 was $10.2 million, as compared to $6.5 million in the fourth quarter
of 2014. The increase over the same period in 2014 was due to increased recognition in Baxalta collaboration revenue as a result of achieving three development milestones totaling $100.0 million in 2015, including two milestones in the fourth
quarter of 2015. Total revenue for the fiscal year 2015 was $30.0 million, as compared to $31.1 million in 2014. The lower revenue for the full year 2015 over the same periods in 2014 was due to the full recognition of a $10.0 million
substantive milestone payment from Baxalta earned in third quarter of 2014, in addition to the collaboration and license revenue recognized over the estimated period of the collaboration.
Research and development (R&D) expenses for the fourth quarter 2015 were $51.4 million compared to $26.9 million for the same period in
2014. R&D expenses were $213.1 million in 2015 compared to $78.2 million in 2014. Increases in R&D expenses were mainly attributable to a transition to Phase 3 and Biologics License Application (BLA) enabling studies for CHS-0214,
CHS-1420 and CHS-1701, as well as manufacturing efforts to support clinical trial supply and product registration activities. Less impactful were additional costs associated with the preclinical development of second wave product pipeline and
General and administrative (G&A) expenses for the fourth quarter 2015 were $11.0 million, compared to $6.2 million for the
same period in 2014. G&A expenses were $36.0 million in 2015 compared to $17.6 million in 2014. Changes in G&A expenses were mainly attributable to employee-related expenses, 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 fourth quarter 2015 was $52.4 million, or $1.35 per share, compared to $29.1 million, or $1.47 per share, for the same period in 2014. Net loss attributable to Coherus was $223.3 million, or $6.01 per share, in 2015 compared to $87.1 million, or
$10.64 per share, in 2014.
Cash and cash equivalents totaled $158.2 million as of December 31, 2015, compared to $150.4 million as of
When: February 29, 2016, 1:30 p.m. PT
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Conference ID: 52921197
Please join the conference call at least 10 minutes early to register.
The webcast of the conference call will be available for replay through March 14, 2016.
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
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, initiate and complete bridging studies for CHS-0214, complete its
PK/PD study for CHS-1701, file BLAs for CHS-1701 in the U.S., file an MAA for CHS-0214 in the E.U., file at least one IND on a second wave biosimilar pipeline candidate and enter into
collaborations for CHS-1701 commercialization ex-U.S. and for its anti-inflammatory pipeline. 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 December 31, Twelve Months Ended December 31,
2015 2014 2015 2014
(unaudited)
Revenue:
Collaboration and license revenue $ 10,198 $ 5,313 $ 30,041 $ 28,481
Collaboration and license revenue - related party (1) 448 1,893
Other revenue 732 732
Total revenue 10,198 6,493 30,041 31,106
Operating expenses:
Research and development 51,433 26,867 213,062 78,224
General and administrative 10,972 6,186 36,046 17,564
Total operating expenses 62,405 33,053 249,108 95,788
Loss from operations (52,207 ) (26,560 ) (219,067 ) (64,682 )
Interest expense (33 ) (3,900 )
Other expense, net (373 ) (2,463 ) (4,838 ) (18,595 )
Net loss (52,580 ) (29,023 ) (223,938 ) (87,177 )
Net loss (income) attributable to non-controlling interest 189 (111 ) 678 44
Net loss attributable to Coherus $ (52,391 ) $ (29,134 ) $ (223,260 ) $ (87,133 )
Net loss per share attributable to Coherus, basic and diluted $ (1.35 ) $ (1.47 ) $ (6.01 ) $ (10.64 )
Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted 38,935,832 19,841,728 37,122,008 8,186,529
Coherus BioSciences, Inc.
Condensed Consolidated Balance Sheets
December 31, 2015 December 31, 2014
Assets
Cash and cash equivalents $ 158,226 $ 150,392
Other assets 54,158 36,829
Total assets $ 212,384 $ 187,221
Liabilities and Stockholders Equity (Deficit)
Deferred revenue 94,959 62,699
Other liabilities 124,354 57,765
Total stockholders equity (deficit) (6,929 ) 66,757
Total liabilities and stockholders equity (deficit) $ 212,384 $ 187,221
Last updated: Feb 29, 2016