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Coherus BioSciences Reports Fourth Quarter and Full Year 2020 Financial Results
- Product revenues of
- Expanding late-stage opportunities with Junshi Biosciences immuno-oncology collaboration with first BLA filing expected this year -
- Pipeline progress with CHS-1420 (adalimumab biosimilar) BLA accepted by FDA and FYB201 (ranibizumab biosimilar) BLA on track for mid-year filing -
- Conference call and webcast today at
UDENYCA® (pegfilgrastim-cbqv) delivered strong results in 2020:
$476 millionin net sales for the full year; $110 millionfor the fourth quarter.
- With excellent commercial execution in the face of COVID-19 headwinds, maintained position as leading pegfilgrastim biosimilar in
the United Stateswith 21% share of the overall pegfilgrastim market and nearly 50% share of the pre-filled syringe segment.
Financial strength to execute on our immuno-oncology and biosimilar pipeline and commercial plans:
- Cash flow from operating activities was
$154 millionfor 2020 and $33 millionfor the fourth quarter of 2020.
- Coherus had cash and cash equivalents of
$541 millionat December 31, 2020.
- Net income was
$132 millionfor 2020, or $1.62per share on a diluted basis, and for the fourth quarter of 2020 was $10 million, or $0.12per share on a diluted basis.
“We are very pleased with the strong performance of UDENYCA® in the face of challenging COVID-19 conditions in 2020 and with the recent progress of our biosimilar pipeline candidates,” said
Pipeline Progress and Recent Corporate Highlights
Immuno-oncology collaboration with Junshi Biosciences: In February, Coherus announced a collaboration with Junshi Biosciences for the development and commercialization of Junshi Biosciences’ anti-PD-1 antibody, toripalimab, in the United States and Canada. Upon satisfaction of closing conditions, which is expected to occur in the first quarter 2021, Coherus and Junshi Biosciences will co-develop toripalimab, and Coherus will be responsible for all commercial activities in the United Statesand Canada.
U.S.Food and Drug Administration (“FDA”) has granted breakthrough therapy designation to toripalimab for third-line nasopharyngeal carcinoma (“NPC”), and Coherus expects the first toripalimab biologics license application (“BLA”) to be filed with the FDA for this indication in 2021. On February 20, 2021, Junshi Biosciences announced the approval in Chinaof toripalimab for the treatment of patients with recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy.
- Coherus and Junshi Biosciences plan to file additional toripalimab BLA supplements with the FDA over the next three years for multiple rare and highly prevalent tumor types, including non-small cell lung cancer (“NSCLC”).
- FYB201, a biosimilar Lucentis® (ranibizumab) product candidate in collaboration with
Bioeq AG: Bioeq expects to file the FYB201 BLA mid-year 2021 following a supportive pre-BLA meeting with the FDA earlier in the first quarter of 2021. Bioeq reviewed new manufacturing data with the FDA which the agency requested last year, as well as other elements of the BLA filing.
- CHS-1420, a wholly owned biosimilar Humira® (adalimumab) product candidate: The FDA accepted for review the BLA for CHS-1420 and assigned a target action date in
December 2021. Coherus plans to launch CHS-1420 on or after July 1, 2023, if approved.
- IBI-305, a biosimilar Avastin® (bevacizumab) product candidate in collaboration with
Innovent Biologics (Suzhou) Co. Ltd: Earlier in the first quarter of 2021, Coherus initiated the three-way pharmacokinetic study required prior to potential BLA submission later this year.
Fourth Quarter and Full Year 2020 Financial Results
Net product revenue, consisting of net sales of UDENYCA®, was
Research and development (R&D) expenses for the fourth quarter of 2020 were
Selling, general and administrative (SG&A) expenses were relatively unchanged quarter-over-quarter and year-over-year. SG&A expenses for the fourth quarter of 2020 were
Cash and cash equivalents were
Net income for the fourth quarter of 2020 was
Non-GAAP net income for the fourth quarter of 2020 was $18.6 million, or $0.23 per share on a diluted basis, compared to non-GAAP income of $56.7 million, or $0.75 per share on a diluted basis for the same period in 2019. Non-GAAP net income for 2020 was $176.7 million, or $2.16 per share on a diluted basis, compared to non-GAAP income of $133.1 million, or $1.82 per share on a diluted basis for 2019. See “Non-GAAP Financial Measures” below for a discussion on how Coherus calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measures.
Coherus projects lower UDENYCA® net sales revenue in 2021 compared to 2020. Starting from a seasonally low first quarter impacted by customer buying patterns and COVID-19, Coherus expects UDENYCA® revenue and market share to rise over the remainder of the year, assuming treatment patterns normalize as the general population is vaccinated against COVID-19.
Excluding upfront, milestone and development expenses related to the recently announced collaboration with Junshi Biosciences, which is expected to close in the first quarter of 2021, Coherus projects R&D and SG&A expenses combined will increase in 2021 to 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.
Conference Call Information
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 3770488
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 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.
For additional information, please visit www.coherus.com.
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
UDENYCA® is a trademark of
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|
|Net product revenue||$||110,419||$||123,856||$||475,824||$||356,071|
|Cost of goods sold||11,673||7,805||37,667||17,078|
|Research and development||44,628||34,948||142,759||94,188|
|Selling, general and administrative||37,693||36,070||139,079||137,037|
|Total operating expenses||93,994||78,823||319,505||248,303|
|Income from operations||16,425||45,033||156,319||107,768|
|Other income, net||6||721||554||2,608|
|Net income before income taxes||10,760||41,271||135,707||92,775|
|Income tax provision||1,052||2,044||3,463||2,942|
|Net income per share:|
|Weighted-average number of shares used in computing net income per share:|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||541,158||$||177,668|
|Trade receivables, net||157,046||141,992|
|Liabilities and Stockholders’ Equity|
|Accrued rebates, fees and reserve||$||81,529||$||51,120|
|Convertible notes due 2022||79,885||78,542|
|Convertible notes due 2022 - related parties||26,628||26,181|
|Convertible notes due 2026||223,029||—|
|Total stockholders' equity||280,974||105,214|
|Total liabilities and stockholders’ equity||$||841,649||$||408,927|
Condensed Consolidated Cash Flow
|Three Months Ended||Year Ended|
|Cash, cash equivalents and restricted cash at beginning of the period||$||292,905||$||165,166||$||177,908||$||73,191|
|Net cash provided by operating activities||$||33,124||$||17,710||$||154,145||$||28,355|
|Purchases of investments in marketable securities||—||—||(273,845||)||(20,235||)|
|Proceeds from maturities of investments in marketable securities||211,000||5,400||274,000||20,400|
|Upfront and milestone based license fee payments||—||(11,075||)||(7,500||)||(11,075||)|
|Purchases of property and equipment and other investing activities||(944||)||(387||)||(7,056||)||(1,822||)|
|Net cash provided by (used in) investing activities||$||210,056||$||(6,062||)||$||(14,401||)||$||(12,732||)|
|Proceeds related to issuance of Convertible Notes due 2026, net of issuance costs||—||—||222,156||—|
|Purchase of capped call options related to convertible notes due 2026||—||—||(18,170||)||—|
|Proceeds related to the term loan, net of issuance costs||—||—||—||72,955|
|Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs||—||—||—||8,153|
|Proceeds from issuance of common stock upon exercise of stock options||4,414||374||17,428||5,558|
|Proceeds from purchase under the employee stock purchase plan||1,243||1,641||3,800||3,519|
|Principal payments for finance lease obligations and other financing activities||(144||)||(815||)||(1,268||)||(815||)|
|Net cash provided by financing activities||$||5,513||$||1,200||$||223,946||$||89,370|
|Effect of exchange rate changes on cash||—||(106||)||—||(276||)|
|Net increase in cash, cash equivalents and restricted cash||$||248,693||$||12,742||$||363,690||$||104,717|
|Cash, cash equivalents and restricted cash at end of the period||$||541,598||$||177,908||$||541,598||$||177,908|
|Reconciliation of cash, cash equivalents, and restricted cash|
|Cash and cash equivalents||$||541,158||$||177,668||$||541,158||$||177,668|
|Restricted cash – non-current||440||240||440||240|
|Cash, cash equivalents and restricted cash||$||541,598||$||177,908||$||541,598||$||177,908|
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net income, and the related per share measures, which exclude from net income, and the related per share measures, stock-based compensation expense, upfront and milestone payments under the license agreements and the related income tax effect of those non-GAAP adjustments. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus’ business.
Coherus believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Coherus’ results from period to period, and to identify operating trends in Coherus’ business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
Reconciliation of GAAP Net Income to Non-GAAP Net Income
(in thousands, except share and per share data)
|Three Months Ended||Year Ended|
|GAAP net income||$||9,708||$||39,227||$||132,244||$||89,833|
|Stock based compensation expense||9,873||7,272||38,160||33,591|
|Upfront and milestone based license fee payments||—||11,075||7,500||11,075|
|Income tax effect of the above adjustments||(965||)||(909||)||(1,165||)||(1,416||)|
|Non-GAAP net income||$||18,616||$||56,665||$||176,739||$||133,083|
|GAAP net income per share, basic||$||0.13||$||0.56||$||1.85||$||1.29|
|GAAP net income per share, diluted||$||0.12||$||0.53||$||1.62||$||1.23|
|Non-GAAP net income per share, basic||$||0.26||$||0.81||$||2.47||$||1.91|
|Non-GAAP net income per share, diluted||$||0.23||$||0.75||$||2.16||$||1.82|
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Source: Coherus BioSciences, Inc.