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Coherus BioSciences Reports Fourth Quarter and Full Year 2021 Results
– YUSIMRY™ (adalimumab-aqvh), Coherus’ second product, approved by FDA on
– BLAs under FDA review for PD-1 inhibitor toripalimab and CIMERLI™ (ranibizumab-ranq) –
– New FDA filings expected in 2022 for UDENYCA® on-body injector and additional toripalimab indications –
– UDENYCA® delivered net sales of
– Conference call and webcast today at
RECENT EXECUTION ON KEY STRATEGIC INITIATIVES
Building an innovative immuno-oncology company:
U.S. Food and Drug Administration(“FDA”) granted toripalimab BLA priority review for nasopharyngeal carcinoma (“NPC”) and assigned a target action date of April 30, 2022.
- Toripalimab in combination with chemotherapy demonstrated a statistically significant overall survival benefit in prespecified interim analysis of Phase 3 clinical trial in patients with non-small cell lung cancer.
- Initiated process to exercise option to license JS006, a TIGIT targeted antibody being evaluated in combination with toripalimab in an ongoing Phase 1/2 clinical trial.
- Advancing internal immuno-oncology antibody into IND enabling studies.
Diversifying and growing the commercial product portfolio:
- FDA approved YUSIMRY™ (adalimumab-aqvh), a Humira® biosimilar, on
December 17, 2021.
- FDA accepted for review the BLA for CIMERLI™ (ranibizumab-ranq), a Lucentis® biosimilar, and assigned a target action date in
- UDENYCA® (pegfilgrastim-cbqv) on-body injector (“OBI”) achieved both pharmacokinetic and pharmacodynamic bioequivalence in randomized clinical trial, enabling prior approval supplement filing with FDA in 2022; if approved, a UDENYCA OBI would compete directly with Neulasta® Onpro® which retains approximately 50% share of the overall pegfilgrastim market.
“We have made rapid progress transforming Coherus into an innovative immuno-oncology company supported by income from a diversified portfolio of FDA-approved products. In 2022, we expect to launch two new products, if approved, including our first immuno-oncology antibody, toripalimab, addressing an unmet need in nasopharyngeal carcinoma, as well as CIMERLI. We also plan to initiate a clinical trial in
Fourth Quarter and Full Year 2021 Financial Results
Net revenue, consisting of net sales of UDENYCA, was
Cost of goods sold (“COGS”) was
Research and development (“R&D”) expenses for the fourth quarter of 2021 were
Selling, general and administrative (“SG&A”) expenses were
Cash and cash equivalents were
Net loss for the fourth quarter of 2021 was
Non-GAAP net loss for the fourth quarter of 2021 was $35.1 million, or $(0.46) per share on a diluted basis, compared to non-GAAP income of $18.6 million, or $0.23 per share on a diluted basis for the same period in 2020. Non-GAAP net loss for 2021 was $88.5 million, or $(1.17) per share on a diluted basis, compared to non-GAAP income of $176.7 million, or $2.16 per share on a diluted basis for 2020. See “Non-GAAP Financial Measures” below for a discussion on how Coherus calculates non-GAAP net income (loss) and a reconciliation to the most directly comparable GAAP measures.
Coherus projects combined R&D and SG&A expenses in 2022 to be in the 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.
Conference Call Information
Dial-in: (844) 452-6826 (Toll-Free
Conference ID: 3677018
Please dial-in 15 minutes early to ensure a timely connection to the call.
Fourth quarter and full year 2021 financial results are posted on the Coherus website at https://investors.coherus.com/.
Coherus is a commercial stage biopharmaceutical company building an innovative immuno-oncology franchise funded with cash generated by its diversified portfolio of FDA-approved therapeutics. In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. A biologics license application for toripalimab for the treatment of metastatic or recurrent nasopharyngeal carcinoma is currently under priority review by the FDA, with a target action date of April 2022. Toripalimab is also being evaluated in pivotal clinical trials for the treatment of cancers of the lung, breast, liver, skin, kidney, stomach, esophagus, and bladder.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta® in the
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, statements regarding Coherus’ ability to build an innovative immuno-oncology franchise; Coherus’ ability to generate cash; Coherus’ investment plans; Coherus’ expectations for the launch date of YUSIMRY™ (adalimumab-aqvh); projections for combined R&D and SG&A expenses in 2022; expectations for launches of new products and payments of milestone expenses; expectations of future accelerating revenue growth; estimations about the size of the HUMIRA® market; and expectations of the UDENYCA on-body injector to gain approval and address a large market segment. 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; risks relating to the COVID-19 pandemic; risks related to our existing and potential collaboration partners; risks of the drug development position of Coherus’ competitors; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; the risk of FDA review issues, including accepting trial data from outside of
UDENYCA®, YUSIMRY™ and CIMERLI™, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted. Trademarks and trade names of other companies appearing in this Press Release are, to the knowledge of Coherus, the property of their respective owners.
Neulasta® and Onpro® are registered trademarks of Amgen Inc.
Avastin® and Lucentis® are registered trademarks of
Humira® is a registered trademark of AbbVie Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended||Year Ended|
|Costs and expenses:|
|Cost of goods sold||12,104||11,673||57,591||37,667|
|Research and development||50,762||44,628||363,105||142,759|
|Selling, general and administrative||50,052||37,693||169,713||139,079|
|Total costs and expenses||112,918||93,994||590,409||319,505|
|(Loss) income from operations||(39,547||)||16,425||(263,858||)||156,319|
|Other (expense) income, net||(385||)||6||(283||)||554|
|Net (loss) income before income taxes||(45,725||)||10,760||(287,100||)||135,707|
|Income tax provision||—||1,052||—||3,463|
|Net (loss) income||$||(45,725||)||$||9,708||$||(287,100||)||$||132,244|
|Net (loss) income per share:|
|Weighted-average number of shares used in computing net (loss) income per share:|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||417,195||$||541,158|
|Trade receivables, net||123,022||157,046|
|Liabilities and Stockholders’ Equity|
|Accrued rebates, fees and reserve||$||79,027||$||81,529|
|2022 Convertible Notes||81,359||79,885|
|2022 Convertible Notes - related parties||27,120||26,628|
|2026 Convertible Notes||224,288||223,029|
|2025 Term Loan||75,513||74,481|
|Total stockholders' equity||97,726||280,974|
|Total liabilities and stockholders’ equity||$||679,334||$||841,649|
Condensed Consolidated Statements of Cash Flows
|Three Months Ended||Year Ended|
|Cash, cash equivalents and restricted cash at beginning of the period||$||360,980||$||292,905||$||541,598||$||177,908|
|Net cash (used in) provided by operating activities||(52,322||)||33,124||(37,432||)||154,145|
|Purchases of investments in marketable securities||(10,706||)||—||(182,485||)||(273,845||)|
|Proceeds from maturities of investments in marketable securities||36,992||211,000||99,692||274,000|
|Proceeds from sale of investments in marketable securities||81,672||—||81,672||—|
|Upfront and milestone based license fee payments *||—||—||(136,000||)||(7,500||)|
|Cash used in other investing activities||(468||)||(944||)||(1,289||)||(7,056||)|
|Net cash provided by (used in) investing activities||107,490||210,056||(138,410||)||(14,401||)|
|Proceeds related to issuance of 2026 Convertible Notes, net of issuance costs||—||—||—||222,156|
|Purchase of capped call options related to 2026 Convertible Notes||—||—||—||(18,170||)|
|Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs||—||—||40,903||—|
|Proceeds from issuance of common stock upon exercise of stock options||673||4,414||10,399||17,428|
|Proceeds from purchase under the employee stock purchase plan||1,017||1,244||3,002||3,801|
|Cash used in other financing activities||(203||)||(145||)||(2,425||)||(1,269||)|
|Net cash provided by financing activities||1,487||5,513||51,879||223,946|
|Net increase (decrease) in cash, cash equivalents and restricted cash||56,655||248,693||(123,963||)||363,690|
|Cash, cash equivalents and restricted cash at end of the period||$||417,635||$||541,598||$||417,635||$||541,598|
|Reconciliation of cash, cash equivalents, and restricted cash|
|Cash and cash equivalents||$||417,195||$||541,158||$||417,195||$||541,158|
|Restricted cash balance||440||440||440||440|
|Cash, cash equivalents and restricted cash||$||417,635||$||541,598||$||417,635||$||541,598|
* 2021 payments include license fees of
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net income, and the related per share measures, which exclude from net income, and the related per share measures, stock-based compensation expense, upfront payments under its license agreements, milestone payments under its license agreements for periods prior to Q4 2021 only, the related income tax effect of those non-GAAP adjustments and costs related to the termination of the CHS-2020 development program that Coherus announced in
Coherus believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Coherus’ results from period to period, and to identify operating trends in Coherus’ business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
Reconciliation of GAAP Net (Loss) Income to Non-GAAP Net (Loss) Income
(in thousands, except share and per share data)
|Three Months Ended||Year Ended|
|GAAP net (loss) income||$||(45,725||)||$||9,708||$||(287,100||)||$||132,244|
|Stock based compensation expense||10,946||9,873||51,364||38,160|
|Upfront and milestone based license fee payments *||—||—||136,000||7,500|
|Income tax effect of the above adjustments||—||(965||)||—||(1,165||)|
|Costs related to termination of CHS-2020 development program||(292||)||—||11,211||—|
|Non-GAAP net (loss) income||$||(35,071||)||$||18,616||$||(88,525||)||$||176,739|
|GAAP net (loss) income per share, basic||$||(0.60||)||$||0.13||$||(3.81||)||$||1.85|
|GAAP net (loss) income per share, diluted||$||(0.60||)||$||0.12||$||(3.81||)||$||1.62|
|Non-GAAP net (loss) income per share, basic||$||(0.46||)||$||0.26||$||(1.17||)||$||2.47|
|Non-GAAP net (loss) income per share, diluted||$||(0.46||)||$||0.23||$||(1.17||)||$||2.16|
|Shares used in computing basic net (loss) income per share||76,828,940||72,223,970||75,449,632||71,411,705|
|Shares used in computing diluted net (loss) income per share||76,828,940||87,713,218||75,449,632||83,491,898|
* 2021 expense includes license fees of
Chief Financial Officer
Source: Coherus BioSciences, Inc.