NewsView printer-friendly version
Coherus BioSciences Reports Second Quarter 2023 Financial Results and Business Highlights
– Net revenue rose 81% from prior quarter to
– CIMERLI® net sales quadrupled to
– UDENYCA® autoinjector launched in late May, and YUSIMRY™ launched in July –
– Planned merger with Surface Oncology expected to significantly advance
next-generation immuno-oncology pipeline –
– Conference call today at
RECENT BUSINESS HIGHLIGHTS
- CIMERLI® (ranibizumab-eqrn) net product sales more than quadrupled to
$26.7 millioncompared to the prior quarter following the April 1, 2023implementation of the permanent, product-specific Q-code.
- Coherus launched a single-dose, prefilled autoinjector (AI) presentation of UDENYCA® (pegfilgrastim-cbqv) on
May 22, representing the first pegfilgrastim presentation innovation in eight years.
U.S. Food and Drug Administration(FDA) review of the prior approval supplement for Coherus’ third pegfilgrastim presentation, the UDENYCA® On-body Injector (OBI), is ongoing. Coherus plans to launch UDENYCA® OBI directly upon potential approval later this year.
- The FDA completed inspection of the toripalimab manufacturing site in
Chinain May, and has scheduled the clinical site inspections in Chinato begin in the second half of August 2023. Coherus anticipates potential FDA approval and U.S.commercial launch of toripalimab in the second half of 2023.
- The final analysis of the JUPITER-02 clinical trial (NCT03581786) presented at the
American Society of Clinical Oncologyannual meeting in June demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) for nasopharyngeal carcinoma (NPC) patients who were treated with toripalimab in combination with chemotherapy versus chemotherapy alone. Median OS was 33.7 months in the chemotherapy-only treatment arm, and median OS was not reached in the toripalimab arm, with a hazard ratio of 0.63, representing a 37% reduction in risk of death (95% CI 0.45-0.89; p=0.0083).
- Coherus launched YUSIMRY™, a Humira biosimilar, with a citrate-free and
sting-free formulation delivered via a state-of-the-art autoinjector on July 3rd. YUSIMRY™ is now available for sale nationwide through retail, mail order and specialty pharmacy channels.
Surface Oncology Merger and Novel Immuno-oncology Pipeline
- Coherus announced that it had entered into a definitive agreement and plan of merger on
June 16, 2023that would result in the acquisition of Surface Oncology, Inc. (“Surface Oncology”), if completed. The merger is expected to significantly advance Coherus’ next-generation immuno-oncology pipeline focused on the tumor micro-environment with clinical stage anti-IL-27 and anti-CCR8 development programs. The merger is expected to close following the Surface Oncology special meeting of stockholders scheduled on September 7, 2023.
- Patient enrollment continues in the
U.S.-based Phase 1/2a dose expansion clinical trial evaluating CHS-006, a TIGIT-targeted antibody, in combination with toripalimab in patients with advanced solid tumors (NCT05757492).
- Coherus plans to file an Investigational New Drug (“IND”) application by year end for CHS-1000, a novel ILT4-targeted antibody.
“In the second quarter, we had strong execution on our strategy to build an innovative immuno-oncology company funded by revenues from FDA-approved products, and we made good progress across all areas of our business. Compared to the prior quarter, net revenues increased by 81% to
SECOND QUARTER 2023 FINANCIAL RESULTS
Net revenue was
Cost of goods sold (COGS) for the three months ended
Research and development (R&D) expense for the three months ended
Selling, general and administrative (SG&A) expense was
Net loss for the second quarter of 2023 was
Non-GAAP net loss for the second quarter of 2023 was
Cash, cash equivalents and investments in marketable securities were
2023 Revenue and R&D and SG&A Expense Guidance
Coherus expects its 2023 net product revenue will exceed
Coherus projects combined R&D and SG&A expenses for 2023 to be in the range of
This financial guidance also 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 circumstances 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
To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI3fdbdc05783442f89d11db6b94e74a28
Please dial-in 15 minutes early to ensure a timely connection to the call.
Webcast Link: https://edge.media-server.com/mmc/p/irz4npdq
A replay of the webcast will be archived on the “Investors” section of the Coherus website at http://investors.coherus.com.
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. 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
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, and YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®.
Neulasta® is a registered trademark of Amgen, Inc.
Lucentis® is a registered trademark of
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, statements regarding Coherus’ ability to build its immuno-oncology franchise to achieve a leading market position; Coherus’ ability to generate cash and net sales; Coherus’ investment plans; Coherus’ future projections for R&D expense, SG&A expense, net product revenue and CIMERLI® revenue; Coherus’ expectations about its ability to close the acquisition of Surface Oncology in the third quarter of 2023 or at all; Coherus’ expectations about advancing its pipeline and achieving better outcomes than checkpoint inhibitors can on their own; Coherus’ expectations about launching new products and Coherus’ timing and ability to file an IND for CHS-1000.
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 finish inspections in
UDENYCA®, CIMERLI® and YUSIMRY™, 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.
Coherus Contact Information:
SVP, Investor Relations
VP, Corporate Communications
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|Costs and expenses:|
|Cost of goods sold||24,848||11,277||41,722||20,647|
|Research and development||23,267||41,611||57,421||124,528|
|Selling, general and administrative||45,144||51,276||94,297||100,029|
|Total costs and expenses||93,259||104,164||193,440||245,204|
|Loss from operations||(34,543||)||(44,013||)||(102,288||)||(124,938||)|
|Loss on debt extinguishment||—||—||—||(6,222||)|
|Other income (expense), net||1,617||443||3,345||475|
|Loss before income taxes||(42,869||)||(50,150||)||(118,598||)||(146,234||)|
|Income tax provision||—||—||—||—|
|Basic and diluted net loss per share||$||(0.49||)||$||(0.65||)||$||(1.42||)||$||(1.89||)|
|Weighted-average number of shares used in computing basic and diluted net loss per share||87,269,614||77,554,717||83,469,247||77,405,040|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||72,920||$||63,547|
|Investments in marketable securities||71,792||128,134|
|Trade receivables, net||141,308||109,964|
|Liabilities and Stockholders’ Deficit|
|Accrued rebates, fees and reserve||$||84,210||$||54,461|
|Total stockholders' deficit||(174,764||)||(137,418||)|
|Total liabilities and stockholders’ deficit||$||469,591||$||480,847|
Condensed Consolidated Statements of Cash Flows
|Three Months Ended||Six Months Ended|
|Cash, cash equivalents and restricted cash at beginning of the period||$||16,585||$||326,120||$||63,987||$||417,635|
|Net cash used in operating activities||(38,915||)||(50,037||)||(107,647||)||(104,082||)|
|Purchases of investments in marketable securities||(19,507||)||—||(19,507||)||—|
|Proceeds from maturities of investments in marketable securities||47,250||—||64,750||—|
|Proceeds from sale of investments in marketable securities||13,282||—||13,282||—|
|Option payment to Junshi Biosciences||—||—||—||(35,000||)|
|Other investing activities, net||340||(880||)||366||(1,495||)|
|Net cash provided by (used in) investing activities||41,365||(880||)||58,891||(36,495||)|
|Proceeds from 2027 Term Loans, net of debt discount & issuance costs||—||—||—||191,190|
|Proceeds from issuance of common stock under ATM Offering, net of issuance costs||(74||)||—||6,761||—|
|Proceeds from issuance of common stock under Public Offering, net of issuance costs||53,625||—||53,625||—|
|Proceeds from issuance of common stock upon exercise of stock options||14||8||117||552|
|Proceeds from purchase under the employee stock purchase plan||1,337||1,655||1,337||1,655|
|Taxes paid related to net share settlement of RSUs||(305||)||(642||)||(3,086||)||(3,300||)|
|Repayment of 2022 Convertible Notes and premiums||—||—||—||(109,000||)|
|Repayment of 2025 Term Loan, premiums and exit fees||—||—||—||(81,750||)|
|Other financing activities||(272||)||(300||)||(625||)||(481||)|
|Net cash provided by (used in) financing activities||54,325||721||58,129||(1,134||)|
|Net increase (decrease) in cash, cash equivalents and restricted cash||56,775||(50,196||)||9,373||(141,711||)|
|Cash, cash equivalents and restricted cash at end of the period||$||73,360||$||275,924||$||73,360||$||275,924|
|Reconciliation of cash, cash equivalents, and restricted cash|
|Cash and cash equivalents||$||72,920||$||275,484||$||72,920||$||275,484|
|Restricted cash balance||440||440||440||440|
|Cash, cash equivalents and restricted cash||$||73,360||$||275,924||$||73,360||$||275,924|
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net loss, and the related per share measures, which exclude from net loss, and the related per share measures, stock-based compensation expense, loss on debt extinguishment and restructuring charges related to our reduction in workforce. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus’ business.
Coherus believes that the presentation of these non-GAAP financial measures provides useful supplemental information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Coherus’ results from period to period, and to identify operating trends in Coherus’ business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
Reconciliation of GAAP Net Loss to Non-GAAP Net Loss
(in thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|GAAP net loss||$||(42,869||)||$||(50,150||)||$||(118,598||)||$||(146,234||)|
|Stock-based compensation expense(1)||10,077||13,850||21,410||26,729|
|Loss on debt extinguishment||—||—||—||6,222|
|Restructuring charges related to reduction in workforce(1)||—||—||4,876||—|
|Non-GAAP net loss||$||(32,792||)||$||(36,300||)||$||(92,312||)||$||(113,283||)|
|GAAP net loss per share, basic and diluted||$||(0.49||)||$||(0.65||)||$||(1.42||)||$||(1.89||)|
|Non-GAAP net loss per share, basic and diluted||$||(0.38||)||$||(0.47||)||$||(1.11||)||$||(1.46||)|
|Shares used in computing basic and diluted net loss per share||87,269,614||77,554,717||83,469,247||77,405,040|
(1) In the six months ended
Source: Coherus BioSciences, Inc.