Release Details
Coherus Oncology Reports Second Quarter 2025 Financial Results and Provides Business Update
– LOQTORZI net revenue was
– Data readouts for CHS-114 and casdozokitug on track for 1H 2026 –
– Q2 2025 ending cash, cash equivalents and marketable securities of
– Conference call today at
“Coherus Oncology is dedicated to significantly extending survival for people with cancer,” said
“Our pipeline clinical programs with CHS-114 and casdozkitug in solid tumors are progressing and on track for data readouts in 2026,” said
RECENT BUSINESS HIGHLIGHTS
LOQTORZI® (toripalimab-tpzi) COMMERCIAL UPDATES
- LOQTORZI is the only FDA-approved and available treatment in the
U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), in all patient subsets and across all lines of therapy. - LOQTORZI net revenue for Q2 2025 was
$10.0 million , a 36% growth over LOQTORZI net revenue of$7.3 million in Q1 2025. This growth was driven largely by higher patient demand and some inventory restocking. LOQTORZI net revenue was $3.8 million in Q2 2024. - Following a recent revision in the National Comprehensive Cancer Network (NCCN) guidelines granting LOQTORZI preferred status for NPC indication, the Company has seen strong demand growth among Head & Neck cancer specialists. The Company’s focus remains on deepening adoption within the community oncologist setting.
ADVANCEMENT OF INNOVATIVE,
LOQTORZI is a next-generation, differentiated PD-1 marketed in the
- Coherus plans to maximize the value of this medicine by combining LOQTORZI with internal pipeline candidates, CHS-114 and casdozokitug, for additional solid tumor indications and entering into capital-efficient external partnerships for label expansions.
CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.
- Phase 1b CHS-114/toripalimab combination dose optimization studies in 2L head and neck (HNSCC) and 2L gastric cancers are underway, with initial data readouts expected in 1H 2026.
- A Phase 1b study evaluating the CHS-114/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in 1H 2026.
Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC).
- Enrollment is ongoing in the Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC, with the first data readout expected in 1H 2026.
UDENYCA DIVESTITURE COMPLETED AND CERTAIN FINANCIAL OBLIGATIONS PAID OFF
On
During Q2 2025, the Company used a portion of the proceeds from the UDENYCA sale to: (1) repay substantially all of the
SECOND QUARTER 2025 FINANCIAL RESULTS
Net revenue from continuing operations was approximately
Cost of goods sold (COGS) from continuing operations was
Research and development (R&D) expenses from continuing operations were
Selling, general and administrative (SG&A) expenses from continuing operations were
Interest expense from continuing operations was
Net loss from continuing operations for the second quarter of 2025 was
Non-GAAP net loss from continuing operations for the second quarter of 2025 was
Net income from discontinued operations, net of tax was
The increases compared to the prior year periods were primarily due to the
The increase in the six-month period was partially offset by
Cash, cash equivalents and marketable securities totaled
Conference Call Information
When:
To access the conference call:
- TOLL-FREE DIAL-IN: (800) 715-9871
- INTERNATIONAL DIAL-IN: (646) 307-1963
- Conference ID 8712736
Webcast: https://edge.media-server.com/mmc/p/skv7e6d2
A live and archived webcast will be available on the “Investors” section of the Coherus website at https://investors.coherus.com/events-presentations.
Please dial in 15 minutes early to ensure a timely connection to the call.
About Coherus Oncology
Coherus Oncology is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI® (toripalimab-tpzi), growing revenues and a promising proprietary pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. The Company’s strategy is to grow sales of LOQTORZI in NPC and advance the development of new indications for LOQTORZI in combination with both their pipeline candidates as well as its partners, driving sales multiples and synergies from proprietary combinations.
Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in multiple Phase 1/2 and Phase 2 studies in patients with advanced solid tumors, including NSCLC and HCC. CHS-114 is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1b studies in patients with advanced solid tumors, including HNSCC, gastric cancer, and esophageal cancer.
For more information about LOQTORZI, including the
Forward-Looking Statements
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’ expectations about identifying sales multiples and synergies; the ability of Coherus’ I-O pipeline to enhance outcomes for cancer patients; projections for cash runway; the ability to reduce risk for Coherus’ pipeline; Coherus’ ability to receive the potential milestone payments related to the divestiture of its UDENYCA franchise; expectations for the timing when Coherus will be able to commence future clinical studies or receive clinical data for its product candidates; Coherus’ ability to enter into additional partnerships; Coherus’ ability to grow revenues; and Coherus’ expectations about total addressable opportunity for each of its product candidates.
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 related to Coherus’ dependence on an ability to raise funds in the future, which may not be available on acceptable terms or at all; risks related to Coherus’ 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 and the timing of Coherus’ regulatory filings; the risk of FDA review issues; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ quarterly report on Form 10-Q for the fiscal quarter ended
LOQTORZI®, whether or not appearing in large print or with the trademark symbol, is a registered trademark of
©2025
Coherus Contact Information:
For Investors & Media:
VP, Investor Relations & Corporate Communications
IR@coherus.com
Condensed Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited) |
||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net revenue | $ | 10,254 | $ | 10,296 | $ | 17,853 | $ | 12,604 | ||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods sold | 3,395 | 1,809 | 6,048 | 3,248 | ||||||||||||
| Research and development | 26,306 | 20,598 | 50,662 | 49,022 | ||||||||||||
| Selling, general and administrative | 26,039 | 27,515 | 52,064 | 67,747 | ||||||||||||
| Total costs and expenses | 55,740 | 49,922 | 108,774 | 120,017 | ||||||||||||
| Loss from operations | (45,486 | ) | (39,626 | ) | (90,921 | ) | (107,413 | ) | ||||||||
| Interest expense | (2,277 | ) | (4,062 | ) | (4,427 | ) | (7,180 | ) | ||||||||
| Loss on debt extinguishment | — | (12,630 | ) | — | (12,630 | ) | ||||||||||
| Other income (expense), net | 2,901 | 1,467 | 3,088 | 4,336 | ||||||||||||
| Loss from continuing operations before income taxes | (44,862 | ) | (54,851 | ) | (92,260 | ) | (122,887 | ) | ||||||||
| Income tax provision | — | — | — | — | ||||||||||||
| Net loss from continuing operations | (44,862 | ) | (54,851 | ) | (92,260 | ) | (122,887 | ) | ||||||||
| Net income from discontinued operations, net of tax | 342,629 | 41,930 | 333,458 | 212,841 | ||||||||||||
| Net income (loss) | $ | 297,767 | $ | (12,921 | ) | $ | 241,198 | $ | 89,954 | |||||||
| Net income (loss) per share: | ||||||||||||||||
| Net loss from continuing operations - basic and diluted | $ | (0.39 | ) | $ | (0.48 | ) | $ | (0.80 | ) | $ | (1.08 | ) | ||||
| Net income from discontinued operations - basic and diluted | $ | 2.95 | $ | 0.37 | $ | 2.88 | $ | 1.87 | ||||||||
| Net income (loss) per share - basic and diluted | $ | 2.57 | $ | (0.11 | ) | $ | 2.08 | $ | 0.79 | |||||||
| Weighted-average number of shares used in computing net income (loss) per share: | ||||||||||||||||
| Basic and diluted | 116,077,710 | 114,819,965 | 115,968,352 | 113,784,636 | ||||||||||||
Condensed Consolidated Balance Sheets (in thousands) (unaudited) |
|||||||
| 2025 | 2024 |
||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 216,893 | $ | 125,987 | |||
| Investments in marketable securities | 20,744 | — | |||||
| Trade receivables, net | 5,109 | 111,324 | |||||
| 114,530 | 11,010 | ||||||
| Inventory | 4,513 | 4,207 | |||||
| Intangible assets, net | 52,312 | 53,646 | |||||
| Other assets | 25,363 | 25,936 | |||||
| Assets of discontinued operations | — | 116,423 | |||||
| Total assets | $ | 439,464 | $ | 448,533 | |||
| Liabilities and Stockholders’ Equity (Deficit) | |||||||
| Accrued rebates, fees and reserve | $ | 96,814 | $ | 164,867 | |||
| 103,999 | 11,026 | ||||||
| Term loan | 36,867 | 36,698 | |||||
| Convertible notes | 121 | 228,229 | |||||
| Other liabilities | 81,836 | 139,703 | |||||
| Total stockholders' equity (deficit) | 119,827 | (131,990 | ) | ||||
| Total liabilities and stockholders’ equity (deficit) | $ | 439,464 | $ | 448,533 | |||
Condensed Consolidated Statements of Cash Flows (in thousands) (unaudited) |
||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Cash, cash equivalents and restricted cash at beginning of the period | $ | 82,674 | $ | 260,227 | $ | 126,250 | $ | 103,343 | ||||||||
| Net cash (used in) provided by operating activities | (46,632 | ) | 59,734 | (72,458 | ) | 12,968 | ||||||||||
| Purchases of investments in marketable securities | (20,726 | ) | — | (20,726 | ) | — | ||||||||||
| Proceeds from maturities of investments in marketable securities | — | — | — | 6,200 | ||||||||||||
| Proceeds from sale of investments in marketable securities | — | — | — | 8,688 | ||||||||||||
| Net cash received related to the Sale Transactions | 483,400 | 40,000 | 478,681 | 227,823 | ||||||||||||
| Milestone payment to Junshi Biosciences | — | (12,500 | ) | (12,500 | ) | (12,500 | ) | |||||||||
| Other investing activities, net | (36 | ) | 156 | (303 | ) | 208 | ||||||||||
| Net cash provided by investing activities | 462,638 | 27,656 | 445,152 | 230,419 | ||||||||||||
| Proceeds from 2029 Term loan, net of debt discount & issuance costs | — | 37,120 | — | 37,120 | ||||||||||||
| Proceeds from (repayment of) Revenue Purchase and Sale Agreement, net of issuance costs | (47,652 | ) | 36,495 | (47,652 | ) | 36,495 | ||||||||||
| Proceeds from issuance of common stock under ATM Offering, net of issuance costs | — | (52 | ) | — | 1,455 | |||||||||||
| Proceeds from purchase under the employee stock purchase plan | 188 | 685 | 188 | 685 | ||||||||||||
| Taxes paid related to net share settlement | (16 | ) | (1,711 | ) | (280 | ) | (2,456 | ) | ||||||||
| Redemption of 2026 Convertible Notes, including transaction costs | (233,185 | ) | — | (233,185 | ) | — | ||||||||||
| Repayment of 2027 Term Loans, premiums and fees | — | (260,387 | ) | — | (260,387 | ) | ||||||||||
| Other financing activities, net | (859 | ) | (75 | ) | (859 | ) | 50 | |||||||||
| Net cash used in financing activities | (281,524 | ) | (187,925 | ) | (281,788 | ) | (187,038 | ) | ||||||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | 134,482 | (100,535 | ) | 90,906 | 56,349 | |||||||||||
| Cash, cash equivalents and restricted cash at end of the period | $ | 217,156 | $ | 159,692 | $ | 217,156 | $ | 159,692 | ||||||||
| Reconciliation of cash, cash equivalents, and restricted cash | ||||||||||||||||
| Cash and cash equivalents | $ | 216,893 | $ | 159,240 | $ | 216,893 | $ | 159,240 | ||||||||
| Restricted cash balance | 263 | 452 | 263 | 452 | ||||||||||||
| Cash, cash equivalents and restricted cash | $ | 217,156 | $ | 159,692 | $ | 217,156 | $ | 159,692 | ||||||||
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 from continuing operations, and the related per share measures, which exclude from net loss from continuing operations, and the related per share measures, stock-based compensation expense, amortization of intangible assets, loss on debt extinguishment, impairments of intangible assets, and change in fair value of our Royalty Fee Derivative Liability. 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 from Continuing Operations to Non-GAAP Net Loss from Continuing Operations (in thousands, except share and per share data) (unaudited) |
||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| GAAP net loss from continuing operations | $ | (44,862 | ) | $ | (54,851 | ) | $ | (92,260 | ) | $ | (122,887 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation expense | 5,166 | 6,859 | 10,212 | 13,675 | ||||||||||||
| Loss on debt extinguishment | — | 12,630 | — | 12,630 | ||||||||||||
| Impairment of out-license asset and remeasurement of CVR liability, net | — | — | — | 6,772 | ||||||||||||
| Change in fair value of Royalty Fee Derivative Liability | — | — | 810 | — | ||||||||||||
| Amortization of intangible assets | 667 | 679 | 1,334 | 1,542 | ||||||||||||
| Non-GAAP net loss from continuing operations | $ | (39,029 | ) | $ | (34,683 | ) | $ | (79,904 | ) | $ | (88,268 | ) | ||||
| GAAP | ||||||||||||||||
| Net loss per share from continuing operations, basic and diluted | $ | (0.39 | ) | $ | (0.48 | ) | $ | (0.80 | ) | $ | (1.08 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 116,077,710 | 114,819,965 | 115,968,352 | 113,784,636 | ||||||||||||
| Non-GAAP | ||||||||||||||||
| Net loss per share from continuing operations, basic and diluted | $ | (0.34 | ) | $ | (0.30 | ) | $ | (0.69 | ) | $ | (0.78 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 116,077,710 | 114,819,965 | 115,968,352 | 113,784,636 | ||||||||||||
Source: Coherus Oncology, Inc.