Adagio Medical Holdings, Inc.(ADGM) - 2025 Q2 - Quarterly Results

Introduction Adagio Medical Holdings, Inc. announced its financial results for the second quarter ended June 30, 2025, highlighting its focus on catheter ablation technologies for cardiac arrhythmias - Adagio Medical Holdings, Inc. (Nasdaq: ADGM) reported Q2 2025 financial results[1] Recent Business Highlights The company reported strong progress in its FULCRUM-VT study enrollment and advanced its next-generation product pipeline, alongside achieving a reduced cash burn due to corporate prioritization CEO Commentary CEO Todd Usen highlighted strong momentum in FULCRUM-VT study enrollment, validating market need, and significant progress in developing the next-generation product to enhance usability and ULTC platform capabilities - CEO Todd Usen noted strong momentum in FULCRUM-VT study enrollment, validating market need for ULTC solutions for ventricular tachycardia[3] - The company made progress in advancing its next-generation product, designed to improve physician usability and enhance ULTC platform capabilities[3] Key Operational Achievements Adagio surpassed 85% enrollment in its FULCRUM-VT pivotal study, published first-in-human results for its PARALELL study on Pulsed Field Cryoablation, and reduced cash burn through corporate prioritization - Surpassed 85% enrollment in the FULCRUM-VT pivotal study for the vCLAS™ Cryoablation System, targeting 206 patients across 20 U.S. and Canadian centers, on track for completion in H2 2025[6] - First-in-human results from the PARALELL study, evaluating Pulsed Field Cryoablation (PFCA), were published in the Journal of Cardiovascular Electrophysiology[6] - Reduced cash burn quarter-over-quarter due to corporate prioritization and resource realignment[6] Second Quarter 2025 Financial Results Overview Adagio Medical reported a reduced net loss of $3.9 million for Q2 2025, down from $5.7 million in Q2 2024, with corresponding improvements in basic net loss per share. The company held $8.2 million in cash and cash equivalents as of June 30, 2025 Q2 2025 vs Q2 2024 Key Financials | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | | :-------------------------------- | :----------------- | :----------------- | :---------------- | | Cost of revenue | $0.3 | $0.7 | -$0.4 | | Research and development expenses | $2.0 | $2.9 | -$0.9 | | Selling, general and administrative expenses | $2.4 | $3.4 | -$1.0 | | Net loss | $(3.9) | $(5.7) | +$1.8 | | Basic net loss per share | $(0.26) | $(7.35) | +$7.09 | - Cash and cash equivalents stood at $8.2 million as of June 30, 2025[5] About Adagio Medical Holdings, Inc. Adagio Medical is a medical device company specializing in Ultra-Low Temperature Cryoablation (ULTC) technology for cardiac arrhythmias, particularly ventricular tachycardia (VT). Its vCLAS™ Cryoablation System is CE Marked and undergoing a pivotal U.S. IDE study (FULCRUM-VT) for FDA approval Company Profile and Technology Adagio develops and commercializes catheter-based Ultra-Low Temperature Cryoablation (ULTC) technology, designed to create large, durable lesions for treating cardiac arrhythmias, with a current focus on ventricular tachycardia (VT) using its vCLAS™ Cryoablation System - Adagio is a medical device company focused on developing and commercializing products for cardiac arrhythmias using proprietary catheter-based Ultra-Low Temperature Cryoablation (ULTC) technology[6] - ULTC technology is designed to create large, durable lesions through cardiac tissue[6] - The company's vCLAS™ Cryoablation System is CE Marked and is currently under evaluation in the FULCRUM-VT U.S. IDE Pivotal Study for ventricular tachycardia (VT)[7] FULCRUM-VT Study Details FULCRUM-VT is a prospective, multi-center, open-label, single-arm study enrolling 206 patients with structural heart disease and drug-refractory VT, aiming to support FDA premarket approval for Adagio's vCLAS™ Cryoablation System for a broad indication of scar-mediated VT - FULCRUM-VT is a prospective, multi-center, open-label, single-arm study enrolling 206 patients with structural heart disease and drug-refractory VT[8] - Study results will be used for FDA premarket approval (PMA) for Adagio's vCLAS™ Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT[8] Product Commercialization Status Adagio's vCLAS™ Cryoablation System is commercially available for monomorphic ventricular tachycardia treatment in Europe and other select regions, but its use in the United States is currently limited to investigational purposes - The vCLAS™ Cryoablation System is commercially available for monomorphic ventricular tachycardia treatment in Europe and select other geographies[9] - In the United States, the vCLAS™ Cryoablation System is limited to investigational use[9] Financial Statements The financial statements provide detailed balance sheet data as of June 30, 2025, and statements of operations for the three months ended June 30, 2025 and 2024, showing changes in assets, liabilities, equity, revenues, and expenses Condensed Balance Sheets As of June 30, 2025, Adagio reported $8.2 million in cash and cash equivalents, with total assets of $35.88 million, total liabilities of $27.21 million, and total stockholders' equity of $8.67 million Condensed Balance Sheet Data (in thousands) | Metric | As of 6/30/2025 (Thousands) | As of 12/31/2024 (Thousands) | | :---------------------- | :-------------------------- | :--------------------------- | | Cash and cash equivalents | $8,200 | $20,586 | | Total assets | $35,876 | $48,448 | | Total Liabilities | $27,210 | $28,536 | | Total stockholders' equity | $8,666 | $19,912 | Condensed Statements of Operations For Q2 2025, the company reported no revenue, a net loss of $3.95 million (compared to $5.73 million in Q2 2024), and a basic net loss per share of $(0.26) (compared to $(7.35) in Q2 2024). Operating expenses significantly decreased year-over-year Condensed Statements of Operations (Three months ended June 30, in thousands) | Metric | 2025 (Thousands) | 2024 (Thousands) | Change (2025 vs 2024) (Thousands) | | :------------------------------------ | :--------------- | :--------------- | :-------------------------------- | | Revenue | $— | $254 | -$254 | | Cost of revenue | $342 | $682 | -$340 | | Research and development | $1,971 | $2,865 | -$894 | | Selling, general, and administrative | $2,404 | $3,366 | -$962 | | Total cost of revenue and operating expenses | $4,717 | $6,913 | -$2,196 | | Loss from operations | $(4,717) | $(6,659) | +$1,942 | | Net loss | $(3,947) | $(5,734) | +$1,787 | | Basic net loss per share | $(0.26) | $(7.35) | +$7.09 | | Diluted net loss per share | $(0.35) | $(7.35) | +$7.00 | | Weighted average shares outstanding, basic and diluted | 15,381,565 | 779,908 | +14,601,657 | Forward-Looking Statements This section contains standard forward-looking statements regarding the potential of Adagio's products, R&D plans, regulatory approvals, and financial resources, emphasizing that actual results may differ due to various risks and uncertainties detailed in SEC filings - Forward-looking statements cover product potential, R&D plans, regulatory approvals (FDA/foreign agencies), and financial resources[10] - These statements are subject to risks and uncertainties that could cause actual results to differ materially, as detailed in Adagio's SEC filings[10] Contact Information Contact details for investor and media inquiries are provided, listing Debbie Kaster, Chief Business Officer, as the primary contact - Contact for inquiries is Debbie Kaster, Chief Business Officer, via dkaster@adagiomedical.com[11]