NewsView printer-friendly version
Coherus BioSciences Reports Fourth Quarter and Full Year 2022 Results
– Net product sales of
– FDA is planning the toripalimab manufacturing site inspection in Q2 2023 –
– UDENYCA® autoinjector approved by FDA; UDENYCA® on-body injector under review by FDA –
– Planning underway for potential 2023 commercial launches of toripalimab, YUSIMRY™, UDENYCA® AI and UDENYCA® OBI –
– Conference call today at
RECENT BUSINESS HIGHLIGHTS
U.S. Food and Drug Administration(FDA) has notified the Company of the planned dates in the second quarter of 2023 for its required inspection of the toripalimab manufacturing facility in China. The inspection, previously hindered by COVID-related travel restrictions, is part of the FDA’s review of the biologics license application (BLA) for toripalimab, a PD-1 inhibitor for the treatment of nasopharyngeal carcinoma (NPC). Coherus plans to launch toripalimab in the U.S.directly upon potential approval by the FDA.
- The FDA on
March 3, 2023approved a single-dose, prefilled autoinjector presentation of UDENYCA® (pegfilgrastim-cbqv), which represents the first presentation innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative treatments that expand access and address the needs of patients undergoing cancer treatment. Coherus plans to launch UDENYCA® AI in the second quarter.
- The FDA review of the prior approval supplement for Coherus’ third pegfilgrastim presentation, the UDENYCA® on-body injector (OBI), is ongoing, and Coherus plans to launch UDENYCA® OBI directly upon potential approval later this year.
- In February, the
U.S. Centers for Medicare & Medicaid Services(CMS) assigned to CIMERLI® (ranibizumab-eqrn) a permanent, product-specific Q-code, which will become active on April 1, 2023. The Q-code is expected to enable more efficient billing processes and speed time to reimbursement for providers.
March 3, 2023, Coherus implemented a reduction in force impacting approximately 60 full-time and part-time employees in order to focus resources on strategic priorities including the commercialization of its diversified product portfolio and development of innovative immuno-oncology product candidates.
- Coherus is introducing a guidance range of combined R&D and SG&A expenses for 2023 of
$315to $335 million. This guidance reflects nearly $100 millionin expense reductions compared to prior 2023 guidance provided in April 2022.
“2023 will be a year of continued transformation for Coherus with significant value drivers including four anticipated product launches and multiple upcoming clinical catalysts,” said
FOURTH QUARTER and FULL YEAR 2022 FINANCIAL RESULTS
Net revenue was
Cost of goods sold (COGS) was
Research and development (R&D) expense for the three months ended
Selling, general and administrative (SG&A) expense was
Net loss for the fourth quarter of 2022 was
Non-GAAP net loss for the fourth quarter of 2022 was $47.1 million, or $(0.60) per share on a basic and diluted basis, compared to non-GAAP net loss of $35.1 million, or $(0.46) per share on a basic and diluted basis for the same period in 2021. Non-GAAP net loss for the full year of 2022 was $234.8 million, or $(3.02) per share on a basic and diluted basis, compared to non-GAAP net loss of $224.5 million, or $(2.98) per share on a basic and diluted basis for the full year of 2021. Beginning in the first quarter of 2022, the Company no longer regularly excludes upfront and milestone-based license fee payments from its non-GAAP financial information. To conform to this change, the prior period non-GAAP financial information has been recast to include upfront and milestone-based license fee payments. See “Non-GAAP Financial Measures” below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.
Cash, cash equivalents and investments in marketable securities were
2023 R&D and SG&A Expense Guidance
Coherus is introducing a guidance range of combined 2023 R&D and SG&A expenses from
Conference Call Information
Please register through the following link for dial-in information and personal PIN:
Please register 15 minutes early to ensure a timely connection to the call.
A replay of the webcast will be archived at https://investors.coherus.com/
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer and the commercialization of our portfolio of FDA-approved therapeutics. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics.
In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. The BLA for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma is currently under review by the FDA.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, and CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, in the U.S., and expects to launch the FDA-approved Humira® biosimilar YUSIMRY™ (adalimumab-aqvh) in the U.S. in 2023.
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 its immuno-oncology franchise to achieve a leading market position; Coherus’ ability to generate cash; Coherus’ investment plans; Coherus’ future projections for R&D and SG&A expenses and the year in which it will become profitable and whether it can meet those projections; Coherus’ launch date for YUSIMRY™; Coherus’ ability to launch multiple new products and find catalysts in the future; Coherus’ ability to increase revenues and decrease expenses; and the impact of the CIMERLI® Q-code.
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 Coherus’ competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus’ business, the need to schedule inspections in
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.
|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||14,202||12,104||70,083||57,591|
|Research and development||29,022||50,762||199,358||363,105|
|Selling, general and administrative||53,621||50,052||198,481||169,713|
|Total costs and expenses||96,845||112,918||467,922||590,409|
|Loss from operations||(51,493||)||(39,547||)||(256,880||)||(263,858||)|
|Loss on debt extinguishment||—||—||(6,222||)||—|
|Other income (expense), net||2,008||(385||)||3,822||(283||)|
|Loss before income taxes||(58,870||)||(45,725||)||(291,754||)||(287,100||)|
|Income tax provision||—||—||—||—|
|Basic and diluted net loss per share||$||(0.76||)||$||(0.60||)||$||(3.76||)||$||(3.81||)|
|Weighted-average number of shares used in computing basic and diluted net loss per share||77,955,769||76,828,940||77,630,020||75,449,632|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||63,547||$||417,195|
|Investments in marketable securities||128,134||—|
|Trade receivables, net||109,964||123,022|
|Liabilities and Stockholders’ Equity (Deficit)|
|Accrued rebates, fees and reserve||$||54,461||$||79,027|
|Total stockholders' equity (deficit)||(137,418||)||97,726|
|Total liabilities and stockholders’ equity (deficit)||$||480,847||$||679,334|
|Condensed Consolidated Statements of Cash Flows|
|Three Months Ended||Year Ended|
|Cash, cash equivalents and restricted cash at beginning of the period||$||287,245||$||360,980||$||417,635||$||541,598|
|Net cash used in operating activities||(99,953||)||(52,322||)||(241,124||)||(37,432||)|
|Purchases of investments in marketable securities||(127,382||)||(10,706||)||(127,382||)||(182,485||)|
|Proceeds from maturities of investments in marketable securities||—||36,992||—||99,692|
|Proceeds from sale of investments in marketable securities||—||81,672||—||81,672|
|Upfront and option payments to Junshi Biosciences(1)||—||—||(35,000||)||(136,000||)|
|Cash used in other investing activities||(2,516||)||(468||)||(4,468||)||(1,289||)|
|Net cash (used in) provided by investing activities||(129,898||)||107,490||(166,850||)||(138,410||)|
|Proceeds from 2027 Term Loans, net of debt discount & issuance costs||—||—||240,679||—|
|Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs||—||—||—||40,903|
|Proceeds from issuance of common stock upon exercise of stock options||60||673||691||10,399|
|Proceeds from issuance of common stock under ATM Offering, net of issuance costs||6,358||—||6,358||—|
|Proceeds from purchase under the employee stock purchase plan||665||1,017||2,320||3,002|
|Taxes paid related to net share settlement of RSUs||(123||)||(23||)||(3,744||)||(1,753||)|
|Repayment of 2022 Convertible Notes and premiums||—||—||(109,000||)||—|
|Repayment of 2025 Term Loan, premiums and exit fees||—||—||(81,750||)||—|
|Other financing activities||(367||)||(180||)||(1,228||)||(672||)|
|Net cash provided by financing activities||6,593||1,487||54,326||51,879|
|Net (decrease) increase in cash, cash equivalents and restricted cash||(223,258||)||56,655||(353,648||)||(123,963||)|
|Cash, cash equivalents and restricted cash at end of the period||$||63,987||$||417,635||$||63,987||$||417,635|
|Reconciliation of cash, cash equivalents, and restricted cash|
|Cash and cash equivalents||$||63,547||$||417,195||$||63,547||$||417,195|
|Restricted cash balance||440||440||440||440|
|Cash, cash equivalents and restricted cash||$||63,987||$||417,635||$||63,987||$||417,635|
(1) 2021 payments include license fees of
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net loss, and the related per share measures, which exclude from net loss, and the related per share measures, stock-based compensation expense, loss on debt extinguishment and costs related to the termination of the CHS-2020 development program that Coherus announced in
Coherus believes that the presentation of these non-GAAP financial measures provides useful supplemental information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Coherus’ results from period to period, and to identify operating trends in Coherus’ business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
|Reconciliation of GAAP Net Loss to Non-GAAP Net Loss (1)|
|(in thousands, except share and per share data)|
|Three Months Ended||Year Ended|
|GAAP net loss||$||(58,870||)||$||(45,725||)||$||(291,754||)||$||(287,100||)|
|Stock-based compensation expense||11,726||10,946||50,737||51,364|
|Loss on debt extinguishment||—||—||6,222||—|
|Costs related to termination of CHS-2020 development program||—||(292||)||—||11,211|
|Non-GAAP net loss||$||(47,144||)||$||(35,071||)||$||(234,795||)||$||(224,525||)|
|GAAP net loss per share, basic and diluted||$||(0.76||)||$||(0.60||)||$||(3.76||)||$||(3.81||)|
|Non-GAAP net loss per share, basic and diluted||$||(0.60||)||$||(0.46||)||$||(3.02||)||$||(2.98||)|
|Shares used in computing basic and diluted net loss per share||77,955,769||76,828,940||77,630,020||75,449,632|
(1) Beginning in the first quarter of 2022, the Company no longer regularly excludes upfront and milestone-based license fee payments from its non-GAAP financial information. To conform to this change, the prior period non-GAAP financial information has been recast to include upfront and milestone-based license fee payments.
SVP, Investor Relations
Source: Coherus BioSciences, Inc.