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Coherus BioSciences Reports Second Quarter 2021 Financial Results and Immuno-oncology and Biosimilar Pipeline Progress
–1st line nasopharyngeal indication and 2nd/3rd line indications to be concurrently submitted 3Q 2021
in the toripalimab BLA —
– CHS-201 (Lucentis® biosimilar) BLA submitted to FDA –
–CHS-1420 (Humira® biosimilar) BLA review progressing with December target action date –
– Second quarter 2021 UDENYCA® net sales of
– Conference call today at
“With two biosimilar BLAs currently under FDA review and a toripalimab BLA submission expected to be completed soon, we are making strong progress toward our objective to diversify and grow our product portfolio,” said
SECOND QUARTER 2021 FINANCIAL HIGHLIGHTS
- Net product revenue, consisting of net sales of UDENYCA® (pegfilgrastim-cbqv) was
- GAAP net loss of
$29.9 millionwas primarily driven by increased R&D and regulatory expenses to support the advancement of toripalimab and the biosimilar pipeline product candidates.
- Non-GAAP net loss was
June 30, 2021, Coherus had cash, cash equivalents and marketable securities of $454.4 million.
April 2021, the Company received $50million from Junshi Biosciences’ acquisition of 2,491,988 shares of Coherus stock.
Coherus is planning an analyst day event in the fourth quarter of 2021
Toripalimab, a PD-1 blocking antibody product candidate, in collaboration with Junshi Biosciences:
- Following a recent meeting with the
United States Food and Drug Administration(“FDA”), Coherus’ immuno-oncology partner, Junshi Biosciences, plans to submit the biologics license application (“BLA”) for toripalimab in combination with chemotherapy for 1st line treatment of metastatic or recurrent nasopharyngeal carcinoma (“NPC”) concurrently with toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. Junshi Biosciences expects to complete the BLA submission for these indications later this quarter.
- Data from a Phase 3 clinical trial evaluating toripalimab for the treatment of non-small cell lung cancer will be presented in September at the
World Conference on Lung Cancer.
- Data from a Phase 3 clinical trial evaluating toripalimab for the treatment of esophageal squamous cell carcinoma will be presented in September at the annual meeting of the
European Society for Medical Oncology.
CHS-201, a biosimilar Lucentis® (ranibizumab) product candidate in collaboration with
Bioeq AGrecently submitted the CHS-201 BLA. Pending acceptance of the BLA by the FDA, Coherus anticipates a mid-2022 target action date for the BLA review.
CHS-1420, a wholly owned biosimilar Humira® (adalimumab) product candidate:
- The review of the CHS-1420 BLA is progressing with a target action date of
December 2021. Coherus plans to launch CHS-1420 on or after July 1, 2023, if approved.
CHS-305, a biosimilar Avastin® (bevacizumab) product candidate in collaboration with
- Coherus is conducting the three-way pharmacokinetic study to facilitate the potential CHS-305 BLA submission.
SECOND QUARTER 2021 FINANCIAL RESULTS
Net product revenue, consisting of net sales of UDENYCA®, was
Cost of goods sold (COGS), increased to
Research and development (R&D) expense for the three months ended
Selling, general and administrative (SG&A) expense for the three months ended
Net loss for the second quarter of 2021 was
Non-GAAP net loss for the second quarter of 2021 was $27.3 million, or $0.36 per share on a diluted basis, compared to non-GAAP net income of $68.3 million, or $0.81 per share on a diluted basis for the same period in 2020. See “Non-GAAP Financial Measures” below for a discussion on how Coherus calculates non-GAAP net (loss) income and a reconciliation to the most directly comparable GAAP measures.
Cash, cash equivalents and investments in marketable securities were
2021 FINANCIAL OUTLOOK
Excluding the upfront payment made to Junshi Biosciences in the first quarter, Coherus projects full year 2021 R&D and SG&A expenses in a range of
This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below and the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended
Conference Call Information
Dial-in: (844) 452-6826 (Toll-Free
Conference ID: 9146617
Please dial-in 15 minutes early to ensure a timely connection to the call.
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.
For additional information, please visit www.coherus.com.
UDENYCA® is a trademark of Coherus BioSciences, Inc.
Avastin® and Lucentis® are registered trademarks of Genentech, Inc.
Humira® is a registered trademark of AbbVie Inc.
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 maintain UDENYCA® market share and position as leading pegfilgrastim biosimilar in
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|Net product revenue||$||87,643||$||135,674||$||170,677||$||251,854|
|Cost of goods sold||16,696||10,139||24,207||16,994|
|Research and development||54,766||26,173||258,258||59,280|
|Selling, general and administrative||40,345||34,052||79,736||69,402|
|Total operating expenses||111,807||70,364||362,201||145,676|
|(Loss) Income from operations||(24,164||)||65,310||(191,524||)||106,178|
|Other income, net||11||423||72||491|
|Net (loss) income before income taxes||(29,900||)||60,325||(202,847||)||96,830|
|Income tax provision||—||1,294||—||2,227|
|Net (loss) income||$||(29,900||)||$||59,031||$||(202,847||)||$||94,603|
|Net (loss) income per share:|
|Weighted-average number of shares used in computing net (loss) income per share:|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||329,738||$||541,158|
|Investments in marketable securities||124,683||—|
|Trade receivables, net||141,825||157,046|
|Liabilities and Stockholders’ Equity|
|Accrued rebates, fees and reserves||$||83,758||$||81,529|
|Convertible notes due 2022*||80,605||79,885|
|Convertible notes due 2022 - related parties*||26,868||26,628|
|Convertible notes due 2026||223,655||223,029|
|Term loan - current portion||11,538||—|
|Term loan-non - current portion||63,420||74,481|
|Total stockholders' equity||156,220||280,974|
|Total liabilities and stockholders’ equity||$||739,542||$||841,649|
* The Convertible notes due 2022 and the Convertible notes due 2022 - related parties were classified in current liabilities as of
Condensed Consolidated Cash Flow
|Three Months Ended||Six Months Ended|
|Cash, cash equivalents and restricted cash at beginning of the period||$||259,929||$||193,692||$||541,598||$||177,908|
|Net cash (used in) provided by operating activities||$||(188||)||$||60,191||$||1,179||$||73,668|
|Purchases of investments in marketable securities||—||(231,864||)||(140,330||)||(231,864||)|
|Proceeds from maturities of investments in marketable securities||15,000||—||15,000||—|
|Upfront license fee payments*||9,000||(5,000||)||(136,000||)||(5,000||)|
|Cash used in other investing activities||(415||)||(2,384||)||(560||)||(4,000||)|
|Net cash provided by (used in) investing activities||$||23,585||$||(239,248||)||$||(261,890||)||$||(240,864||)|
|Proceeds from issuance of Convertible Notes due 2026, net of issuance costs||—||222,830||—||222,830|
|Purchase of capped call options related to convertible notes due 2026||—||(18,170||)||—||(18,170||)|
|Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs||40,903||—||40,903||—|
|Proceeds from issuance of common stock upon exercise of stock options||4,117||3,302||8,446||8,105|
|Proceeds from purchase under the employee stock purchase plan||1,985||2,557||1,985||2,557|
|Cash used in other financing activities||(153||)||(97||)||(2,043||)||(977||)|
|Net cash provided by financing activities||$||46,852||$||210,422||$||49,291||$||214,345|
|Net increase in cash, cash equivalents and restricted cash||$||70,249||$||31,365||$||(211,420||)||$||47,149|
|Cash, cash equivalents and restricted cash at end of the period||$||330,178||$||225,057||$||330,178||$||225,057|
|Reconciliation of cash, cash equivalents, and restricted cash|
|Cash and cash equivalents||$||329,738||224,617||$||329,738||224,617|
|Restricted cash balance||440||440||440||440|
|Cash, cash equivalents and restricted cash||$||330,178||$||225,057||$||330,178||$||225,057|
* 2021 payments includes license fees of
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net income, and the related per share measures, which exclude from net (loss) income, and the related per share measures, stock-based compensation expense, upfront and milestone payments under the license agreements, costs related to termination of a research and development program as part of a strategic realignment of research and development resources toward other development programs and the related income tax effect of those non-GAAP adjustments. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus’ business.
Coherus believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Coherus’ results from period to period, and to identify operating trends in Coherus’ business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
Reconciliation of GAAP Net (Loss) Income to Non-GAAP Net (Loss) Income
(in thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|GAAP net (loss) income||$||(29,900||)||$||59,031||$||(202,847||)||$||94,603|
|Stock-based compensation expense||11,595||9,425||28,479||18,980|
|Upfront license fees*||(9,000||)||—||136,000||5,000|
|Costs related to termination of CHS-2020 development program||—||—||11,503||—|
|Income tax effect of the above adjustments||—||(202||)||—||(552||)|
|Non-GAAP net (loss) income||$||(27,305||)||$||68,254||$||(26,865||)||$||118,031|
|GAAP net (loss) income per share, basic||$||(0.40||)||$||0.83||$||(2.73||)||$||1.33|
|GAAP net (loss) income per share, diluted||$||(0.40||)||$||0.70||$||(2.73||)||$||1.20|
|Non-GAAP net (loss) income per share, basic||$||(0.36||)||$||0.96||$||(0.36||)||$||1.67|
|Non-GAAP net (loss) income per share, diluted||$||(0.36||)||$||0.81||$||(0.36||)||$||1.48|
|Shares used in computing basic net (loss) income per share||75,559,697||71,099,773||74,203,858||70,880,979|
|Shares used in computing diluted net (loss) income per share||75,559,697||88,660,280||74,203,858||83,775,353|
* 2021 expense includes license fees of
Chief Financial Officer
+1 (650) 395-0152
Source: Coherus BioSciences, Inc.