Adagio Medical Holdings (ADGM) risk factors, FY2025 10-K

Risks Related to Our Business

1. 01We are a medical device company that has incurred net losses in every period to date and expect to continue to incur significant losses as we develop our business, and our financial conditions raise substantial doubt about our ability to continue as a going concern44% rewritten
2. 02We have a limited operating history and no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viabilityNew
3. 03We may need to raise additional capital to fund our development and commercialization plans
4. 04Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidatesNew
5. 05Changes in our business strategy or restructuring of our businesses may increase our costs or otherwise affect the profitability of our businesses or the value of our assets
6. 06Our growth and revenue prospects partially depend on our ability to accelerate the commercialization of our products and to capitalize on market opportunities
7. 07Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide
8. 08Because our quarterly and annual results may fluctuate, period-to-period comparisons may not be the best indication of the underlying results of our business and should only be relied upon as one factor in determining how our business is performing
9. 09There is no assurance that we will be able to execute on our business model, including achieving market acceptance of our products
10. 10If we are unable to execute our business model, or if our business model does not drive the growth that we anticipate, or if our market opportunity is not as large as we have estimated, it could adversely affect our business and our prospects
11. 11The size of the markets for our products may be smaller than estimated, limiting our ability to successfully sell our products
12. 12If we or the third parties with whom we work experience disruption in our information technology systems, data, or security incidents, our business could be adversely affected, including our ability to operate, the loss of confidential and proprietary information, increased remediation costs, and reputational damage37% rewritten
13. 13We may be unable to manage our anticipated growth effectively
14. 14We may acquire other companies or technologies, or form strategic partnerships with other companies, which could divert our management’s attention, increase our capital requirements, and otherwise disrupt our operations, subject us to other risks and harm our operating results
15. 15If we are unable to recruit and retain key executives and scientists, we may be unable to achieve our goals
16. 16Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations
17. 17Unfavorable U.S. or global economic conditions as a result of a pandemic, political instability, natural disasters, or otherwise, could adversely affect our ability to raise capital and our business, financial condition and results of operations90% rewritten
18. 18If our facilities become unavailable or inoperable, our research and development program and commercialization launch plan could be adversely affected, which could materially and adversely impact our business, financial condition and results of operations
19. 19We use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly
20. 20International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects New
21. 21Our corporate prioritization initiative may not achieve our intended outcome and may result in significant adverse consequencesNew

Risks Related to our Products

1. 22If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed
2. 23We may not be successful in the commercialization of our products, if approved, if we fail to establish relationships and successfully collaborate with leading life science companies and research institutions or if we are unable to establish effective distribution channels and sales and marketing functions100% rewritten
3. 24Our products may not be successful if there is inadequate physician training, practice and patient selection
4. 25The life sciences industry is highly competitive. Even if our products are commercialized and achieve broad scientific and market acceptance, if we fail to improve them or introduce compelling new products, our revenue and our prospects could be harmed
5. 26If we are unable to establish manufacturing capacity by ourselves or with third-party partners in a timely and cost-effective manner, commercialization of our products would be delayed, which would result in lost revenue and harm our business
6. 27Our products could have unknown defects or errors, which may give rise to claims against us and adversely affect market adoption of our products
7. 28A breakthrough device designation by the FDA for vCLAS TM may not lead to a faster development, regulatory review or approval process, and it may not increase the likelihood that vCLAS TM will receive premarket approval (“PMA”) approval from the FDANew

Risks Related to Our Intellectual Property

1. 29The U.S. law relating to the patentability of certain inventions in the life sciences technology industry is uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future
2. 30Filing, prosecuting, maintaining, and defending patents on our products in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States
3. 31In addition, if we resort to legal proceedings to enforce our intellectual property rights or to determine the validity, scope and coverage of the intellectual property or other proprietary rights of others, the proceedings could be burdensome and expensive, even if we were to prevail74% rewritten
4. 32Issued patents covering our products could be found invalid or unenforceable if challenged, and could materially impact our business
5. 33If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, and our business could be harmed
6. 34We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property, which could have a material adverse effect on our business
7. 35We may not be able to protect and enforce our trademarks and trade names or build name recognition in our markets of interest thereby harming our competitive position, which could have a material adverse effect on our business
8. 36Patent terms may be inadequate to protect our competitive position of our products for an adequate amount of time and may adversely affect our business
9. 37If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the futured and thus materially harm our business
10. 38Our use of open-source software and failure to comply with the terms of the underlying open-source software licenses could impose limitations on our ability to commercialize our products and provide third parties access to our proprietary software, which could have a material adverse effect on our businessNew
11. 39The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage

Risks Related to Regulatory and Legal Compliance Matters

1. 40We expect to incur substantial expenses in our pursuit of regulatory clearances and approvals for our products in the United States and can provide no assurances that we will obtain the necessary approvals from the FDA to market our products in the United States
2. 41We may be subject to enforcement action if we engage in improper or off-label marketing or promotion of our products, including significant legal liability, fines, penalties, and injunctions, which could materially and adversely affect our business, financial condition, and results of operations54% rewritten
3. 42Adverse findings in post-marketing vigilance or regulatory audits could subject us to suspension or withdrawal of our certificates of conformity, mandatory product recalls and significant legal liability, which could materially and adversely affect our business, financial condition, and results of operations42% rewritten
4. 43If we fail to comply with broad and complex healthcare and other laws, we could face substantial penalties and our business, operations, and financial condition could be adversely affectedNew
5. 44To the extent that we implement a telehealth platform, activities undertaken and arrangements implemented in connection with such a platform may implicate other laws such as state physician, pharmacy and telehealth licensure laws, corporate practice of medicine, and fee-splitting lawsNew
6. 45Our employees, independent contractors, consultants, commercial partners, distributors and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
7. 46Recently enacted and future legislation may increase the difficulty and cost for us to commercialize our products and obtain marketing approval of our product candidates and may affect the prices we may obtainNew

Risks Related to Litigation and Regulation

1. 47We are subject to risks relating to disputes and other legal proceedings, product liability lawsuits, that may be time consuming and costly25% rewritten
2. 48We are subject to laws and regulations governing export and import controls, sanctions and embargoes. We could face liability and other serious consequences for violations which can harm our businessNew

Risks Related to Financing Transactions

1. 49There are risks associated with our Convertible Securities Notes that could adversely affect our business and financial condition
2. 50We are subject to risks relating to increased interest rates and any adverse developments in the credit markets

Risks Related to Tax

1. 51Our ability to use net operating loss (“NOL”) carryforwards and other tax attributes may be limited as a result of the Business Combination or other ownership changes21% rewritten
2. 52A new 1% U.S. federal excise tax could be imposed on us in connection with redemptions by us of our stock
3. 53The excise tax is imposed on the repurchasing corporation itself, not its stockholders from which shares are repurchased
4. 54Unanticipated tax laws or any changes in tax rates or in the application of the existing tax laws to us may adversely impact our results of operations23% rewritten
5. 55Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefitsNew

Risks Related to Ownership of Our Securities

1. 56The Perceptive PIPE Investor has control over key decision making as a result of its control of a majority of the voting power of our outstanding common stock
2. 57We may use our financial resources in ways with which you do not agree and in ways that may not yield a favorable return
3. 58Our stock price may be volatile and may decline regardless of our operating performance
4. 59We may be unable to maintain the listing of our securities on Nasdaq in the future
5. 60An active trading market for our common stock may not be sustained
6. 61Sales of a substantial number of shares of our common stock in the public market could cause the market price of our common stock to drop significantly, even if our business is doing wellNew
7. 62We may issue additional shares of common stock or other equity securities without your approval, which would dilute your ownership interests and may depress the market price of the common stock32% rewritten
8. 63If securities or industry analysts either do not publish research about us or publish inaccurate or unfavorable research about us, our business or our market, or if they adversely change their recommendations regarding our common stock, the trading price or trading volume of our common stock could decline
9. 64Our Charter and Bylaws contain provisions that could depress the trading price of common stock by acting to discourage, delay, or prevent a change of control of us or changes in our management that our stockholders may deem advantageous
10. 65Our Charter provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees
11. 66We do not intend to pay dividends for the foreseeable future23% rewritten
12. 67We incur increased costs and demands upon management as a result of being a public company97% rewritten
13. 68We are obligated to maintain proper and effective internal controls over financial reporting, and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common stockNew
14. 69We may become subject to securities or class action litigation, which is expensive and could divert management’s attention