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Coherus BioSciences Reports Third Quarter 2017 Operating and Financial Results
Corporate Highlights for the Third Quarter 2017 Include:
Immunology (anti-TNF) therapeutic franchise:
- CHS-0214 (etanercept (Enbrel®) biosimilar candidate)
- Filed petitions for Inter Partes Review (“IPR”) in
the United StatesPatent and Trademark Office seeking invalidation of U.S. Patents 8,163,522 (“ ‘522 patent”) and 8,063,182,
- (“ ’182 patent”). Both are generally directed to the etanercept protein, the pharmaceutically active component of Enbrel
- We expect the PTAB to enter decisions on whether to institute these two IPRs by
March 13, 2018(for the ’522 patent) and by March 26, 2018(for the ‘182 patent).
- CHS-1420 (adalimumab (Humira®) biosimilar candidate)
- Reported topline results from a pharmacokinetic bioequivalence (“PK BE”) study comparing CHS-1420 to European marketed Humira. The study met the criteria for clinical PK BE on all prospectively defined endpoints and there were no clinically meaningful differences in the safety profile between the two products.
Financial Highlights for the Third Quarter and year-to-date 2017
- Cash used in operations was
$41.5 millionin the third quarter, down 25% from the $55.6 millionused in the second quarter of 2017 and down 43% from the $73.3 millionused in the first quarter of 2017. In August 2017, we announced that Temasek, an investment company headquartered in Singapore, plans to invest up to $150 millionover two tranches. We received the first tranche of $75 millionin aggregate proceeds on August 24, 2017and issued 6,556,116 shares of common stock at an offer price of $11.4397per share. The second tranche is projected to be funded following receipt of the U.S. Food and Drug Administration’s marketing approval for the CHS-1701 pegfilgrastim biosimilar product candidate, subject to market pricing and certain closing conditions at that time, including each party’s final approval.
- Research and development (R&D) expenses for the third quarter of 2017 were
$42.6 million, as compared to $64.6 millionfor the same period in 2016. R&D expenses for the nine months ended September 30, 2017were $130.9 million, as compared to $195.4 millionfor the same period in 2016. Decreases in R&D expenses were mainly attributable to the decline and end of clinical activities for CHS-0214, CHS-1420 and CHS-131 during the preceding twelve months.
- General and administrative (G&A) expenses for the third quarter of 2017 were
$14.0 million, as compared to $13.6 millionfor the same period in 2016. G&A expenses for the nine months ended September 30, 2017were $56.3 million, as compared to $36.3 millionfor the same period in 2016. Changes in G&A expenses were mainly attributable to legal and other professional fees to support intellectual property litigation and IPRs, as well as personnel related costs to support CHS-1701 pre-commercial activities in the first six months of 2017.
- Net loss attributable to Coherus for the third quarter of 2017 was
($59.0) million, or ($1.09)per share, as compared to net income attributable to Coherus of $83.9 million, or $1.67per share, for the same period in 2016.
- Cash, cash equivalents and investments in marketable securities – short term totaled
$150.1 millionas of September 30, 2017, as compared to $118.3 millionas of June 30, 2017.
Guidance for the fourth quarter of 2017 and first half of 2018:
CHS-1701 (pegfilgrastim (Neulasta®) biosimilar)
- Anticipate resubmitting the BLA in the U.S. mid-first quarter of 2018 subject to meeting with
- Anticipate European opinion in the first half of 2018, such timing being dependent upon data requests.
- Commercial partnering discussions continue to be underway for certain ex-U.S. territories.
CHS-3351 (ranibizumab (Lucentis®) biosimilar)
- Prioritizing the development of CHS-3351.
CHS-1420 (adalimumab biosimilar)
- Continue to optimize manufacturing.
CHS-0214 (etanercept biosimilar)
- Focus on regulatory issues through the first half of 2018.
- Provide revised guidance on filing of the marketing authorization application in
CHS-1701 U.S. BLA resubmission.
- Continue to optimize manufacturing.
- Targeting immunology (anti-TNF) partnering therapeutic franchise agreement.
CHS-131 central nervous system anti-inflammatory asset
- Completing additional animal studies on CHS-131 to further validate its mechanism of action and address drug-derived metabolites. Licensing agreement to follow subject to results.
- Anticipate cash use in operations of approximately
$35 - $40 millionin the fourth quarter of 2017, down approximately $5 millionfrom previous guidance, and $30 - $35 millionper quarter in the first half of 2018.
Conference Call Information
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 99333721
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.
Coherus is a leading pure-play, global 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 & marketing 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-1420 (adalimumab biosimilar), CHS-0214 (etanercept biosimilar), and CHS-3351 (ranibizumab biosimilar) as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
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, preclinical and 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’ ability to resubmit a BLA in the US and receive marketing approval in
Enbrel® and Neulasta® are registered trademarks of
Humira® is a registered trademark of
Lucentis® is a registered trademark of
|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,|
|Collaboration and license revenue||$||-||$||162,835||$||1,556||$||189,262|
|Research and development||42,626||64,573||130,901||195,430|
|General and administrative||13,989||13,645||56,325||36,303|
|Total operating expenses||56,615||78,218||187,226||231,733|
|Income (loss) from operations||(56,615||)||84,617||(185,670||)||(42,471||)|
|Other income (expense), net||14||1,647||3,605||(3,762||)|
|Net income (loss)||(58,993||)||83,844||(189,217||)||(51,844||)|
|Net loss attributable to non-controlling interest||4||95||114||428|
|Net income (loss) attributable to Coherus||$||(58,989||)||$||83,939||$||(189,103||)||$||(51,416||)|
|Net income (loss) per share attributable to Coherus|
|Weighted-average number of shares used in computing net
income (loss) per share attributable to Coherus
|Coherus BioSciences, Inc.|
|Condensed Consolidated Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||135,557||$||124,947|
|Investments in marketable securities - short-term||14,493||-|
|Liabilities and Stockholders’ Equity|
|Convertible notes-related parties||25,314||25,064|
|Total stockholders' equity||54,907||19,354|
|Total liabilities and stockholders’ equity||$||189,758||$||178,485|
Senior Vice President, Investor Relations
+1 (650) 649-3527