0002006986-26-000003
SEC filingAdagio Medical Holdings, Inc. (ADGM) reported a net loss of $25.1 million for the fiscal year ended December 31, 2025, with no revenue generated during the period. This follows a strategic realignment in February 2025 that paused the limited European launch of its vCLAS catheter and significantly reduced commercial activities. The company incurred significant operating expenses, including $10.6 million in research and development and $10.6 million in selling, general, and administrative costs. As of December 31, 2025, the company had cash and cash equivalents of $17.1 million and an accumulated deficit of $95.6 million. Management has raised substantial doubt about the company's ability to continue as a going concern, noting that existing cash is insufficient to fund operations for the next twelve months, with resources expected to last only into the third quarter of 2026 based on current plans.
Adagio Medical Holdings reported a net loss of $25.1 million for the fiscal year ended December 31, 2025, compared to a net loss of $53.8 million for the period from July 31, 2024 to December 31, 2024 (Successor) and $21.3 million for the period from January 1, 2024 to July 30, 2024 (Predecessor). The company generated no revenue during FY 2025, representing a decrease of $0.6 million from the prior periods, primarily due to the repurchase of previously sold inventory in connection with the pause in commercial activity in Europe. Total cost of revenue and operating expenses were $21.9 million, consisting of $0.7 million in cost of revenue, $10.6 million in research and development, and $10.6 million in selling, general, and administrative expenses. The company reported a comprehensive loss of $25.2 million, including a foreign currency translation adjustment of -$0.1 million.
The company generated no revenue during FY 2025, compared to $0.3 million and $0.3 million for the periods from July 31, 2024 to December 31, 2024 (Successor) and from January 1, 2024 to July 30, 2024 (Predecessor), respectively. This represents a decrease of $0.6 million. The decrease was primarily due to the repurchase of previously sold inventory during the year ended December 31, 2025, which offset gross sales. This inventory buyback was undertaken in connection with the company's pause in commercial activity in Europe, which was announced in February 2025 as part of a strategic realignment to prioritize the completion of the FULCRUM-VT U.S. pivotal IDE clinical trial and product design optimization program.
With no revenue generated during FY 2025, the company reported negative operating margins. Loss from operations was -$21.9 million, compared to -$62.5 million and -$21.7 million for the prior periods. Cost of revenue decreased by $2.6 million, or 79%, primarily attributable to the pause in commercial activity in Europe and the related inventory buyback. Research and development expenses decreased by $1.6 million, or 13%, driven by a $1.0 million decrease in quality assurance costs, a $0.5 million decrease in pre-clinical trial costs and other research and development costs, and a $0.1 million decrease in operations costs. Selling, general and administrative expenses decreased by $9.5 million, or 47%, primarily due to the absence of SPAC-related corporate expenses that were incurred in prior periods and a decrease in payroll and personnel expenses related to lower headcount.
Net cash used in operating activities was $19.0 million for FY 2025, consisting primarily of a net loss of $25.1 million, adjusted for certain non-cash items of $3.4 million and net changes in operating assets and liabilities of $2.7 million. Net cash used in investing activities was $0.4 million for purchases of property and equipment. Net cash provided by financing activities was $16.1 million, primarily due to proceeds from the 2025 PIPE Financing, net of $2.9 million of issuance costs. As of December 31, 2025, the company had cash and cash equivalents of $17.1 million, total assets of $43.3 million, total liabilities of $30.9 million, and total stockholders' equity of $12.4 million. The company had convertible notes payable of $21.0 million and warrant liabilities of $0.1 million.
Management has raised substantial doubt about the company's ability to continue as a going concern, noting that existing cash and cash equivalents of $17.1 million are insufficient to fund operating and capital expenditure requirements for at least 12 months from the date of issuance of the audited consolidated financial statements. Based on current research and development plans, the company expects to have sufficient resources to fund planned operations into the third quarter of 2026. The company intends to mitigate this by negotiating other cash equity or debt financing in the short-term, continuing to pursue necessary regulatory approvals to launch commercially in the U.S. market, and executing cost-cutting measures to manage cash burn. The company plans to share six-month results of the FULCRUM-VT trial in April 2026 and submit results to support FDA approval application in the first half of 2026.