Organization and Summary of Significant Accounting Policies |
6 Months Ended |
|---|---|
Jun. 30, 2026 | |
| Organization and Summary of Significant Accounting Policies | |
| Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Organization Coherus Oncology, Inc. (the “Company” or “Coherus”) is a fully integrated commercial-stage innovative oncology company with an approved next-generation programmed death receptor-1 (“PD-1”) inhibitor, LOQTORZI® (toripalimab-tpzi), and a pipeline that includes two mid-stage clinical candidates targeting liver, prostate, head & neck, colorectal and other cancers. The Company’s strategy is to grow sales of LOQTORZI in Nasopharyngeal Carcinoma (“NPC”) while advancing the development of its two pipeline candidates in combination with LOQTORZI, and through strategic partnerships. The Company has global rights to both clinical-stage candidates and plans to execute ex-U.S. licensing deals as the clinical data supports such transactions. The UDENYCA Sale represented the last and most significant divestiture of the Company’s biosimilar businesses, which comprised the UDENYCA, YUSIMRY and CIMERLI franchises. Accordingly, the associated results of operations have been classified as discontinued operations in the condensed consolidated financial statements for all periods presented. Refer to Note 6. Discontinued Operations for more information. Liquidity These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As of June 30, 2026, the Company had cash, cash equivalents and marketable securities of $105.3 million and an accumulated deficit of $1.4 billion. Management believes that its cash, cash equivalents and marketable securities are sufficient to continue operating activities for at least 12 months following the issuance date of these condensed consolidated financial statements. The Company does not expect its existing cash, cash equivalents and marketable securities to be sufficient to fund the completion of its clinical trials through commercialization and will need additional funding to support its continuing operations and pursue its long-term business plan. Since inception, the Company has generally incurred losses and negative net cash flows from operations. The Company anticipates incurring additional losses until such time, if ever, that it can generate increased sales through sources which include LOQTORZI, the Company’s drug candidates currently in development, tagmokitug and casdozokitug, and strategic partnerships to generate sales. The Company’s operations have historically been financed primarily through the sale of the Company’s common stock, issuance and incurrence of debt, the Revenue Purchase and Sale Agreement, proceeds from biosimilar product divestitures and sales of the Company’s products. Future capital requirements will depend on many factors, including the timing and extent of cash proceeds from LOQTORZI sales and the related distribution and marketing costs, whether the Company receives either of the Earnout Payments from the sale of the UDENYCA Business, and the timing and extent of spending on research and development. The Company will require additional capital for the development efforts of the Company’s drug candidates, but the Company cannot be certain that any of its product candidates will be successful in clinical trials or receive regulatory approval, which is necessary before they can be commercialized. The Company’s operations are dependent on the growth of LOQTORZI sales, which can be adversely impacted by size of the applicable markets and the degree of market acceptance and adoption by prescribing physicians, healthcare providers and the patients to whom the Company’s medicines are prescribed. There can be no assurance that, in the event the Company requires additional financing, such financing will be available at terms acceptable to the Company, if at all. If additional capital is not available, a failure to generate sufficient cash flows from operations could have a material adverse effect on the Company’s ability to achieve its business objectives and remain in compliance with certain covenants contained in the 2029 Term Loan. Basis of Consolidation and Presentation The accompanying unaudited condensed consolidated financial statements include the accounts of Coherus and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements reflect all adjustments, including normal recurring accruals that the Company believes are necessary to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Form 10-K”) filed with the SEC. Beginning in the first quarter of 2026, the Company changed its presentation of comprehensive income (loss) from two separate statements to one combined statement of operations and comprehensive income (loss). The change affects presentation only and has no impact on comprehensive income (loss). Certain amounts in prior year’s condensed consolidated balance sheet and statement of cash flows have been reclassified to conform with the current period presentation, and these changes had no impact to net income (loss) or the net cash used in operating activities. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Accounting estimates and judgments are inherently uncertain and therefore actual results could differ from these estimates. Restricted Cash As of June 30, 2026 and December 31, 2025, restricted cash consisted of a $0.2 million deposit for a letter of credit provided to secure a lease obligation, which was included in other assets, non-current in the condensed consolidated balance sheets. Segment Reporting and Geographic Disclosures The Company has one reportable and operating segment, which is engaged in developing and commercializing human pharmaceutical products. The Company’s chief executive officer, as the chief operating decision maker (“CODM”), manages and allocates resources to the operations of the Company on an entity-wide basis. Managing and allocating resources on an entity-wide basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions. The CODM assesses operating performance and makes operating decisions primarily based on net income (loss), revenues, cash on-hand and investments, and cash flows. All expense categories on the condensed consolidated statements of operations are significant, and there are no other significant segment expenses that would require disclosure. Asset information is not regularly provided to the CODM for assessing performance and allocating resources other than cash, cash equivalents and investments in marketable securities. Primarily, all revenue is generated and all long-lived assets are maintained in the United States. Royalty and Other Revenue Recognition Royalty revenue from licensees, which is based on sales to third parties of licensed products, is recorded when the third-party sale occurs and the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied) and is classified in other revenue within net revenue. In arrangements where the Company acts as an agent, these transactions are recognized on a net basis in the Company's condensed consolidated statements of operations. Recent Accounting Pronouncements The following are recent accounting pronouncements that the Company has not yet adopted: In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires public entities to disclose certain disaggregated costs and expenses on an annual and interim basis in the notes to the financial statements. It also requires disclosure of the total amount of selling expenses, and the Company’s definition of selling expenses. The Company is currently evaluating the disclosure requirements of this standard and any changes to processes and controls that may be necessary to support adoption. The Company expects the guidance to impact its financial statement disclosures but does not expect adoption to have an impact on its condensed consolidated financial position, results of operations, or cash flows. This standard is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective or retrospective basis. The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the condensed consolidated financial statements as a result of future adoption. |