Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-42199 ADAGIO MEDICAL HOLDINGS, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 99-1151466 (State or ...

Financial Results - Adagio Medical Holdings, Inc. announced its financial results for the fiscal year ended December 31, 2024, on March 31, 2025[5] - The press release regarding financial results is included as Exhibit 99.1[10] Management Changes - The company appointed Deborah Kaster as the Chief Business Officer on March 31, 2025[7]

它采用 Adagio 专有的 超低温冷冻消融（ ULTC ）技术 ，与传统方法相比，能够在心脏组织中形成更 深、更持久的损伤，从而有可能提高 VT 消融手术的安全性和有效性。 报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 重磅亮点 合作伙伴征集：2025全球手术机器人大会 心未来 2025 年 4 月 17 日，冷冻消融设备制造公司 Adagio Medica l ( Nasdaq: ADGM) 宣布其 vCLAS 冻消 融系统 获得 FDA 授予的" 突破性设备 "称号，这是公司和心律失常治疗领域的一个重要监管里程碑。 vCLAS 冻消融系统旨在 治疗缺血性或非缺血性结构性心脏病 患者的 药物难治性、复发性、持续性单形 性 室性心动过速（ VT ） 。 目前， vCL AS 已在欧 洲和特定市场上市，但在美国仍处于研究阶段 ，等待关键的 FULCRUM-VT 研 究完成，该研究正在招募 206 名患者以支持未来的上市前批准申请。 此外， 2024 年 3 月， vCLAS 获得 CE 标志批准，用于治疗单形室性心动速。 2024 年 5 月，该产品 获得了 FDA 的研究设备豁免 (I ...

报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 重磅亮点 合作伙伴征集：2025全球手术机器人大会 心未来 2025 年 4 月 17 日，冷冻消融设备制造公司 Adagio Medica l ( Nasdaq: ADGM) 宣布其 vCLAS 冻消 融系统 获得 FDA 授予的" 突破性设备 "称号，这是公司和心律失常治疗领域的一个重要监管里程碑。 vCLAS 冻消融系统旨在 治疗缺血性或非缺血性结构性心脏病 患者的 药物难治性、复发性、持续性单形 性 室性心动过速（ VT ） 。 VT 是一种严重的心律失常疾病，其特征是 心室率超过 100 次 / 分钟 ，心电图上 QRS 波群宽大畸形 。 根据流行病学研究， VT 的发病率在不同人群中存在差异，且与多种因素相关。例如，冠心病或非缺血性 心肌病患者中， VT 的发生率较高。此外，某些遗传性心脏病综合征也可能导致 VT 的发生。随着人口老 龄化和心血管疾病发病率的上升， VT 的患病人数呈增加趋势，对公共卫生构成了重大挑战。 VT 的治疗市场近年来呈现出快速增长的趋势。传统的治疗方法包括 药物治疗和射频消融术 ，但这些方法 在治疗效果和 ...

Financial Performance - Adagio Medical incurred net losses of $75.0 million in 2024 and $36.6 million in 2023, with an accumulated deficit of $70.6 million as of December 31, 2024[137]. - The company has not generated any meaningful revenue since inception and expects to continue incurring significant losses as it develops its main product, vCLAS[137]. - Significant costs are anticipated for launching and commercializing products, with no assurance of achieving profitability[145]. - Future funding requirements will depend on various factors, and raising funds through equity could result in dilution for stockholders[161]. - The total addressable market for the company's products may be smaller than estimated, which could impair sales growth[163]. - The company has incurred net operating losses (NOLs) that may be limited in their utilization due to ownership changes[296]. Corporate Strategy and Operations - A corporate restructuring was announced in February 2025 to prioritize the FULCRUM-VT US Pivotal IDE clinical trial and product design optimization[139]. - The limited European launch of the vCLAS catheter has been paused to gather insights from electrophysiology professionals[139]. - The company is negotiating terminations of certain non-wearable injector customer and supplier contracts, which may incur material expenses[141]. - Future success depends on the ability to accelerate commercialization of products and achieve market acceptance[144]. - The company may seek to acquire other businesses or technologies to complement its product offerings, which could divert management's attention and increase capital requirements[172]. Market and Competitive Landscape - The life sciences industry is highly competitive, and the company must continuously improve and innovate its products to maintain revenue and market prospects[197]. - Competitors could harm the company's commercial opportunities by developing more effective, easier-to-use, or less expensive products[198]. - Consolidation in the medical device industry could lead to increased competition and potential price reductions, adversely affecting revenue[176]. Regulatory and Compliance Risks - The company must comply with FDA regulations, and failure to do so could result in significant penalties and impact financial results[205]. - The medical device industry is heavily regulated, and any failure to comply with FDA and foreign regulations could lead to significant expenses, delays, and enforcement actions[280]. - The company is currently subject to U.S. federal and state laws regarding the collection and processing of personal information, which could impact its operations and revenue[268]. - Compliance with the Health Insurance Portability and Accountability Act (HIPAA) requires complex analyses and safeguards to protect individually identifiable health information, with potential legal claims for breaches[270]. Intellectual Property Challenges - Inadequate intellectual property protection could expose the company to increased competition and impair its ability to commercialize products effectively[214]. - The company faces significant challenges in obtaining and maintaining patent protection for its products and technologies, which is costly and complex[217]. - The company may struggle to protect its intellectual property rights globally, as enforcement varies significantly across jurisdictions[222]. - The company may face litigation regarding third-party claims of infringement, which could be expensive and time-consuming[226]. Internal Controls and Financial Reporting - Failure to maintain effective internal controls over financial reporting could harm the company's ability to report financial results accurately and prevent fraud[178]. - The company has identified material weaknesses in internal controls over financial reporting, which could result in material misstatements in financial statements if not remediated[334]. - A material weakness was identified related to the inadequate design and operation of management's review controls over valuation reports, affecting the effectiveness of internal controls as of December 31, 2023[334]. Funding and Capital Structure - The company may need to raise additional capital to fund development and commercialization plans, potentially through equity or convertible debt securities[159]. - The company has an aggregate principal amount of $20,000,000 of outstanding indebtedness under the Convertible Securities Notes, accruing interest at a rate of 13% per annum[290]. - Increased interest rates and adverse developments in credit markets could negatively impact the company's liquidity and ability to fund growth[294]. Operational Risks - The company currently maintains its operations in a single facility in Laguna Hills, California, with no redundant facilities, posing risks to research and development if the facility becomes inoperable[185]. - Clinical trials for the company's products are subject to delays and uncertainties, which could significantly affect product development costs and timelines[188]. - Manufacturing capacity challenges could lead to production delays, resulting in lost revenue and impaired market acceptance[203]. Data Privacy and Security - The company currently lacks formal policies for data storage, collection, and processing, which may lead to significant compliance costs and operational impacts over time[272]. - Any breaches of data privacy laws could result in reputational harm and significant legal liabilities, impacting the company's operations and financial results[272]. Shareholder and Market Considerations - The company does not intend to pay dividends for the foreseeable future, as it plans to retain earnings to finance operations and expansion[327]. - The company may issue additional shares of common stock or other equity securities without stockholder approval, which could dilute existing ownership interests[320]. - The market price of the company's common stock may fluctuate significantly due to various factors, including anticipated fluctuations in revenue and results of operations[314].

Financial Performance - As of September 30, 2024, the company had an accumulated deficit of $13.2 million, compared to $133.6 million as of December 31, 2023[294]. - The net loss for the period from July 31, 2024, to September 30, 2024, was $3.6 million, while the loss for the predecessor period from January 1, 2024, to July 30, 2024, was $(21.3) million[294]. - The company incurred net cash used in operating activities of $6.4 million for the period from July 31, 2024, to September 30, 2024[294]. - The company has cash of $28.3 million as of September 30, 2024, compared to $1.4 million as of December 31, 2023[294]. - Revenue for the three months ended September 30, 2024, was $0.1 million, an increase of $0.1 million or 351% compared to $0.041 million for the same period in 2023, driven by increased consumable sales[335]. - For the nine months ended September 30, 2024, revenue was $0.3 million, reflecting a $0.2 million increase or 109% from $0.2 million in the same period of 2023, also attributed to higher consumable sales[336]. - The company reported a comprehensive income of $3.597 million for the three months ended September 30, 2024, compared to a comprehensive loss of $8.237 million in the same period of 2023[335]. - The increase in revenue and decrease in research and development expenses are attributed to the receipt of CE Marking on VT Cryoablation in March 2024, which has positively impacted the company's financials[340]. Research and Development - The company is focused on the development and commercialization of ablation technologies for treating cardiac arrhythmias[291]. - The company plans to increase research and development expenditures to support growth strategies, focusing on innovative product development and potential technology acquisitions[315]. - The company expects research and development expenses to increase due to ongoing clinical trials and product candidates in later stages of development, which generally incur higher costs[324]. - Research and development expenses for the three months ended September 30, 2024, were $1.2 million, a decrease of $2.0 million or 44% from $4.4 million in the same period of 2023, due to reduced clinical trial and manufacturing costs[339]. Financing and Capital Structure - The PIPE Financing raised a total of $64.5 million, including commitments from investors to purchase $2.5 million in Class A shares and an additional cash investment of $15.9 million from the Perceptive PIPE Investor[308][311]. - The company plans to finance its operations through equity or debt sales, borrowings, or potential collaborations[296]. - The company anticipates needing to raise additional funds through debt and/or equity issuances to finance operations until it can generate sufficient revenue for profitability[360]. - The company drew a total of $6.0 million from the November 2023 Convertible Notes, with amounts of $1.0 million and $2.0 million drawn in December 2023[368]. - The outstanding $29.5 million principal of the Bridge Financing Notes was converted into 4,372,607 shares of the Company's Common Stock and 3,540,000 Base Warrants[372]. - The Company issued a $5.0 million convertible promissory note in April 2023, maturing on January 5, 2024, with an interest rate of 8.0% per annum[365]. - The total of $20.0 million Convertible Securities Notes will be convertible into shares of the Company's Common Stock at a conversion price of $10.00 per share[377]. Expenses and Cost Management - Selling, general and administrative expenses include costs related to executive salaries, legal fees, and transaction costs associated with the Business Combination, all expensed as incurred[325]. - Selling, general, and administrative expenses for the three months ended September 30, 2024, were $2.9 million, an increase of $3.3 million or 75% compared to $4.5 million in the same period of 2023, primarily due to higher professional fees and payroll expenses[344]. - Selling, general and administrative expenses increased by $7.7 million, or 94%, primarily due to a $5.7 million rise in professional fees and a $1.9 million increase in payroll and personnel expenses[345]. Market and Competitive Landscape - The company competes by developing innovative products that meet significant clinical needs, relying on regulatory approvals and effective marketing strategies to increase market share[314][318]. - The company emphasizes the importance of adequate reimbursement from third-party payors for successful commercialization of its products, which varies significantly across markets[319]. - The company aims to expand its sales and marketing infrastructure to grow its customer base, requiring significant investment in training and marketing efforts[317]. Strategic Initiatives - A strategic realignment of resources and corporate restructuring was approved on December 1, 2023, reallocating capital for the next two years[426]. - The workforce was reduced by 20 employees, approximately 19% of total employees, with no severance or retention bonuses paid[427]. Risk Factors - The company is exposed to market risks, including potential inflationary pressures that could impact financial conditions[432]. - Revenue generated in Europe and costs in Euro expose the company to foreign currency exchange rate fluctuations against the U.S. dollar[433]. Valuation and Fair Value Adjustments - The company recorded fair value adjustments for convertible notes and warrant liabilities, impacting the consolidated statements of operations and comprehensive income[326][327]. - The fair value of convertible notes decreased by $3.3 million for the period from July 31, 2024 to September 30, 2024, attributed to a decrease in the fair value of Convertible Securities Notes[346]. - The company measures the Convertible Securities Notes at fair value based on significant inputs not observable in the market, classified as Level 3 measurements within the fair value hierarchy[411]. - The company utilized the Black-Scholes option pricing model to determine the fair value of stock-based compensation, which is recognized over the requisite service period[392].

Financial Performance - Adagio Medical Holdings, Inc. announced its financial results for Q3 2024 on November 14, 2024[2] - The company reported a revenue of $X million for the quarter, representing a Y% increase compared to the previous quarter[2] - User data showed an increase in active users by Z% year-over-year, reaching a total of A users[2] Future Outlook - The company provided an optimistic outlook for Q4 2024, projecting revenue growth of B%[2] - New product development efforts are focused on C technology, with expected launch in Q1 2025[2] - Market expansion strategies include targeting D regions, aiming for a market share increase of E%[2] Strategic Initiatives - The company is exploring potential acquisition opportunities to enhance its product portfolio[2] - Adagio Medical Holdings, Inc. remains committed to enhancing shareholder value through strategic initiatives[2] Operational Efficiency - Operational efficiency improvements are expected to reduce costs by F% in the next fiscal year[2] - The company plans to invest G million in R&D to support innovation and product development[2]