Adagio Medical Holdings, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Table of Contents
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| PART I: FINANCIAL INFORMATION | | |
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| Item 1. | Condensed Consolidated Financial Statements | 3 |
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| | Condensed Consolidated Balance Sheets as of September 30, 2025 (Successor) (Unaudited) and December 31, 2024 (Successor) | 3 |
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| | Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2025 (Successor) and for the periods from July 31, 2024 to September 30, 2024 (Successor) and July 1, 2024 to July 30, 2024 (Predecessor), and for the period from January 1, 2024 to July 30, 2024 (Predecessor) | 4 |
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| | Unaudited Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the three and nine months ended September 30, 2025 (Successor), and for the periods from July 31, 2024 to September 30, 2024 (Successor), July 1, 2024 to July 30, 2024 (Predecessor), and January 1, 2024 to July 30, 2024 (Predecessor) | 5 |
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| | Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 (Successor), and for the periods from July 31, 2024 to September 30, 2024 (Successor) and January 1, 2024 to July 30, 2024 (Predecessor) | 7 |
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| | Notes to Condensed Consolidated Financial Statements (Unaudited) | 8 |
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| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 55 |
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| Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 76 |
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| Item 4. | Controls and Procedures | 77 |
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| PART II - OTHER INFORMATION | | |
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| Item 1. | Legal Proceedings | 78 |
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| Item 1A. | Risk Factors | 78 |
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| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 80 |
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| Item 3. | Defaults Upon Senior Securities | 80 |
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| Item 4. | Mine Safety Disclosures | 80 |
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| Item 5. | Other Information | 80 |
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| Item 6. | Exhibits | 81 |
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| SIGNATURES | 82 | |
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following:
| • | our ability to continue to develop innovative, proprietary products that address significant clinical needs in a manner that is safe and effective for patients and easy-to-use for physicians; |
our ability to obtain and maintain regulatory clearances or approvals;
our ability to demonstrate safety and effectiveness in our sponsored and third-party clinical trials;
our ability to increase physician awareness;
our ability to obtain and maintain coverage and adequate reimbursement for procedures using our products;
our ability to attract and retain skilled research, development, sales and clinical personnel;
our ability to cost-effectively manufacture, market and sell our products;
our estimates of our market opportunity;
our expectations regarding the scope of protection from intellectual property rights covering our products;
developments or disputes concerning our intellectual property or other proprietary rights;
timing of and results from our clinical trials and other studies;
marketing clearances and authorization from the FDA and regulators in other jurisdictions;
timing of regulatory filings and feedback;
competition in the markets we serve;
our expectations of the reliability and performance of our products;
our expectations of the benefits of our products to patients, providers, and payors;
| • | the impact of proposed tariffs on our business, including the impact on gross margins related to our international product sales and the impact of resulting economic uncertainty on demand for our products; |
| • | factors impacting the supply chains we rely on, including tariffs and the availability of raw materials and skilled labor serving our suppliers, and the cost of these factors of production which may in turn impact the prices we pay for our devices; |
| • | our reliance on a limited number of suppliers, including sole source suppliers, which may impact the availability of instruments and materials; |
our ability to sustain or increase demand for our products;
our estimates regarding our costs and risks associated with our international operations and expansion;
| • | the effects of our corporate prioritization initiative and our expectations regarding our ability to retain and recruit key personnel; |
our ability to attract and retain employees, including those with specialized skills and experience;
our expectations regarding strategic operations;
our ability to access capital markets;
our ability to fund our working capital requirements;
our compliance with, and the cost of, federal, state, and foreign regulatory requirements;
anticipated trends and challenges in our business and the markets in which we operate; and
our ability to continue as a going concern.
You should not rely on forward-looking statements as predictions of future events. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described under the header “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained herein. The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
The forward-looking statements made in this Quarterly Report on Form 10-Q relate only to events as of the date on which the statements are made, and we undertake no obligation to update them to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect new information or the occurrence of unanticipated events, except as required by law.
References in this Quarterly Report on Form 10-Q to “we,” “us,” “ListCo” or the “Company” refer to Adagio Medical Holdings, Inc. and its consolidated subsidiaries at and after the consummation of the Business Combination (as defined below). References to our “management” or our “management team” refer to our officers and directors. We do not intend our use or display of other companies’ trade names or trademarks to imply an endorsement or sponsorship of us by such companies, or any relationship with any of these companies.
We may announce material business and financial information to our investors using our investor relations website (investors.adagiomedical.com). We therefore encourage investors and others interested in Adagio Medical Holdings, Inc. to review the information that we make available on our website, in addition to following our filings with the Securities and Exchange Commission (the “SEC”) webcasts, press releases and conference calls.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.