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Coherus BioSciences Reports Fourth Quarter and Full Year 2019 Financial Results
– Full Year UDENYCA® Sales of
– Full Year Cash Flow from Operating Activities of
Fourth Quarter 2019 and Recent Corporate Highlights
Coherus’ commercial capabilities advanced its core mission to expand choice, improve patient access and lower healthcare costs in
- UDENYCA® (pegfilgrastim-cbqv) launch continues to deliver strong results using its validated branded-biosimilar approach across all market segments:
• UDENYCA® continues to be the U.S. market-leading pegfilgrastim biosimilar and achieved approximately 20.5% unit market share, as measured by IQVIA, at year-end 2019.
• UDENYCA® was the top pharmaceutical launch in 2019 based on IQVIA sales figures.
- Strong financial position to support pipeline and potential long-term growth:
• Cash flow was positive after just two quarters post-launch in 2019.
• Cash flow from operating activities was
$28.4 millionfor the full year and $17.7 millionfor the fourth quarter of 2019.
• Coherus had cash and cash equivalents of
$177.7 millionat December 31, 2019.
• Net product revenue for the fourth quarter of 2019 was
$123.9 million, and net income was $39.2 million, or $0.53per share on a fully diluted basis.
• Net product revenue for the full-year 2019 was
$356.1 million. Net income attributable to Coherus for the same period was $89.8 million, or $1.23per share on a fully diluted basis.
- Coherus completed key licensing transactions to enhance its midterm product pipeline in
the United States:
• Acquired exclusive rights from
Bioeq AG(“Bioeq”), a Swiss biopharmaceutical joint venture, to commercialize Bioeq’s Lucentis® (ranibizumab) biosimilar candidate in the United States.
• Entered into a license agreement with Innovent Biologics, (
Suzhou) Co., Ltd., (“Innovent”), a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin® (bevacizumab) in the United Statesand Canada.
• Under the terms of the agreement with Innovent, Coherus also acquired an option to commercialize Innovent’s biosimilar to Rituxan® (rituximab) in
the United Statesand Canada.
- The Company advanced its internal pipeline in ophthalmology and immunology:
• Further advanced internally developed ophthalmology product candidate, CHS-2020, a biosimilar candidate to Eylea® (aflibercept), which is in the preclinical stage.
• Completed certain development and regulatory objectives for its internally developed immunology product, CHS-1420, a biosimilar candidate to Humira® (adalimumab), to support a potential BLA filing with the
U.S.FDA in 2020.
Fourth Quarter and Full Year 2019 Financial Results
Net product revenue for fourth quarter of 2019 was
Research and development (R&D) expenses for the fourth quarter of 2019 were
Selling, general and administrative (SG&A) expenses for the fourth quarter of 2019 were
Cash and cash equivalents: As of
Assets and working capital: As of
Net income attributable to the Company for the fourth quarter of 2019 was
Guidance for the Next Twelve Months from
Coherus will continue delivering on the promise of biosimilars and laying the foundation for long-term growth across its three therapeutic areas:
- UDENYCA® (pegfilgrastim-cbqv)
• Maintain market position as the leading pegfilgrastim biosimilar of choice, leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments including ample product supply.
• Increase penetration against all Neulasta® dosage forms, while maintaining average selling price (ASP) discipline.
- Advance its Avastin (bevacizumab) oncology biosimilar candidate in-licensed from Innovent toward the filing of a BLA with the
U.S.FDA in late 2020 or early 2021 depending on FDA interaction timing and development requirements, with an expected launch directly upon approval.
- Diligence the option to commercialize Innovent’s Rituxan (rituximab) oncology biosimilar in the
- Facilitate Bioeq filing a BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in 2020, with expected product launch in
the United Statesto address a $6 billionanti-VEGF ophthalmology market, if approved.
- Advance internally developed CHS-2020 Eylea (aflibercept) ophthalmology biosimilar currently in preclinical stage to an expected Phase 3 clinical trial initiation in 2021, with launch projected in 2025, if approved.
- Complete certain development and regulatory objectives with CHS-1420, Humira (adalimumab) immunology biosimilar candidate to support the filing of a BLA with the
U.S.FDA in 2020 with an expected competitive launch in 2023 in the largest biologics market, if approved.
- The Company has decided to pursue strategic alternatives for its program in CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis.
Conference Call Information
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 9658203
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.
Fourth quarter and full year 2019 financial results, are posted on the Coherus website at https://investors.coherus.com/.
Coherus is a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to
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’ ability to continue delivering on the promise of biosimilars and laying the foundation for long-term growth across its three therapeutic areas; Coherus’ ability to continue to expand choice, improve patient access and lower healthcare costs in
UDENYCA® is a trademark of
Neulasta® and Onpro® are registered trademarks of Amgen Inc.
Avastin®, Rituxan® and Lucentis® are registered trademarks of
Humira® is a registered trademark of AbbVie Inc.
Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc.
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended||Twelve Months Ended|
|Net product revenue||$||123,856||$||-||$||356,071||$||-|
|Cost of goods sold||7,805||-||17,078||-|
|Research and development||34,948||26,662||94,188||110,239|
|Selling, general and administrative||36,070||33,840||137,037||94,177|
|Total operating expenses||78,823||60,502||248,303||204,416|
|Income (loss) from operations||45,033||(60,502||)||107,768||(204,416||)|
|Other income, net||721||340||2,608||4,691|
|Net income (loss) before income taxes||41,271||(62,596||)||92,775||(209,409||)|
|Income tax provision||2,044||-||2,942||-|
|Net income (loss)||39,227||(62,596||)||89,833||(209,409||)|
|Net loss attributable to non-controlling interest||-||-||-||70|
|Net income (loss) attributable to Coherus||$||39,227||$||(62,596||)||$||89,833||$||(209,339||)|
|Net income (loss) per share attributable to Coherus:|
|Weighted-average number of shares used in computing net income (loss) per share attributable to Coherus:|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||177,668||$||72,356|
|Trade receivables, net||141,992||-|
|Liabilities and Stockholders’ Equity (Deficit)|
|Convertible notes - related parties||26,181||25,773|
|Total stockholders' equity (deficit)||105,214||(38,591||)|
|Total liabilities and stockholders’ equity (deficit)||$||408,927||$||99,467|
|Condensed Consolidated Cash Flow|
|Three Months Ended||Twelve Months Ended|
|Cash, cash equivalents and restricted cash at beginning of the period||$||165,166||$||102,037||$||73,191||$||127,756|
|Net cash provided by (used in) operating activities||$||17,710||$||(47,363||)||$||28,355||$||(159,266||)|
|Upfront and milestone payments related to license and collaboration arrangements||(11,075||)||-||(11,075||)||-|
|Cash used in other investing activities||5,013||15,786||(1,657||)||(1,188||)|
|Net cash (used in) provided by investing activities||$||(6,062||)||$||15,786||$||(12,732||)||$||(1,188||)|
|Proceeds from term loan, net of issuance costs||-||-||72,955||-|
|Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs||-||1,462||8,153||101,748|
|Cash provided by other financing activities||1,200||1,131||8,262||3,673|
|Net cash provided by (used in) financing activities||$||1,200||$||2,593||$||89,370||$||105,421|
|Effect of exchange rate changes on cash||(106||)||138||(276||)||468|
|Net increase (decrease) in cash, cash equivalents and restricted cash||$||12,742||$||(28,846||)||$||104,717||$||(54,565||)|
|Cash, cash equivalents and restricted cash at end of the period||$||177,908||$||73,191||$||177,908||$||73,191|
|Reconciliation of cash, cash equivalents, and restricted cash|
|Cash and cash equivalents||$||177,668||$||72,356||$||177,668||$||72,356|
|Restricted cash balance||240||835||240||835|
|Cash, cash equivalents and restricted cash||$||177,908||$||73,191||$||177,908||$||73,191|
VP, Investor Relations & Corporate Affairs
+1 (650) 395-0196
Source: Coherus BioSciences, Inc.