Anteris Technologies Global (AVR) risk factors, FY2025 10-K

Risks Related to Our Operating History and Financial Position

1. 01We have a history of operating losses and may not achieve or maintain profitability in the future
2. 02We may encounter difficulties in managing our growth, which could negatively impact our operations
3. 03If we are unable to successfully manage our growth and the increased complexity of our operations, our business, financial position, results of operations and prospects may be harmed
4. 04Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business. Furthermore, our stock price may decline due in part to the volatility of the stock market and the general economic downturn

Risks Related to Our Industry

1. 05Unsuccessful clinical trials or procedures relating to products could have a material adverse effect on our future prospects
2. 06If any of these risks materialize, we could experience significant delays or an inability to successfully develop and commercialize our products, which would have a material adverse effect on our business, financial condition and results of operations
3. 07Even if a product receives regulatory clearance or approval, it may still face development and regulatory difficulties that could delay or impair future sales of products
4. 08Even with regulatory clearance or approval to bring a product to market, our profitability may be impacted by ongoing coverage and reimbursement determinations by government health care programs and other third-party payors for our products, or procedures and services that rely on our products
5. 09Participation in government health care programs and contracts with third-party payors will require ongoing compliance with federal and state health care laws and agreement terms
6. 10Our products that are in development may not achieve market acceptance, if approved, which could limit our growth and adversely affect our business, financial condition and results of operations
7. 11Failure to successfully innovate and develop new and differentiated products in a timely manner and effectively market these products could have a material effect on our prospects
8. 12We may find it difficult to enroll patients in our clinical trials, and patients could discontinue their participation in clinical trials, which could delay or prevent clinical trials and make those trials more expensive to undertake
9. 13Interim, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
10. 14We operate in a highly competitive and rapidly changing industry, and if we do not compete effectively, our business will be harmed
11. 15The success of many of our products may depend upon the knowledge and experience of certain key physicians and heart valve centers

Risks Related to Our Operations

1. 16Our operating results could be adversely affected if we are unable to accurately forecast demand for any of our products that receive marketing clearance or approval and if we are unable to adequately manage our inventory
2. 17The expansion of our manufacturing capabilities may be unsuccessful
3. 18QMED, which provides clinical trial support for the EU, including the provision of life science services in the areas of regulatory affairs, training, quality assurance and control, clinical trial consultancy and submission support to the EU authorities
4. 19We rely on third parties for the supply of materials and for the design and manufacture of our products. Any failure by or loss of a vendor could result in delays and increased costs, which may adversely affect our business
5. 20We have limited control over our suppliers, contract manufacturers, and logistic partners, and such limited control could subject us to significant risks, including the potential inability to produce or obtain quality products and services on a timely basis or in sufficient quantity
6. 21Health and safety hazards may adversely affect our business operations
7. 22Our R&D efforts will be jeopardized if we are unable to retain key personnel and cultivate key academic and scientific collaborations
8. 23We may in the future seek to identify and acquire certain assets, products and businesses, and there can be no guarantee that we will be able to successfully consummate such transactions
9. 24To the extent we are able to enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations and alliances
10. 25We are subject to various risks relating to international activities that could affect our overall profitability
11. 26We are subject to risks associated with currency fluctuations and changes in foreign currency exchange rates could impact our results of operations
12. 27Any failure to protect our information technology infrastructure and our products against cyber-based attacks, network security breaches, service interruptions, artificial intelligence or data corruption could materially disrupt our operations and adversely affect our business and operating results
13. 28Artificial intelligence technologies could present business, compliance and reputational risks
14. 29Our business, data, services and products are or may become subject to United States federal and state and international data privacy laws and regulations and any failure to comply with these laws and regulations could harm our reputation, expose us to damages and otherwise adversely affect our business
15. 30Increased emphasis on environmental, social, and governance (“ESG”) matters may have an adverse effect on our business, financial condition, results of operations and reputation

Risks Related to Legal and Regulatory Matters

1. 31We could become exposed to product liability claims that could harm our business and we may be unable to obtain insurance coverage at acceptable costs and adequate levels
2. 32Use of our products in unapproved circumstances could expose us to liabilities
3. 33Disputes could substantially disrupt our business operations
4. 34Our products and operations are subject to extensive government regulation, including environmental, health and safety regulations, which could result in substantial costs and any failure to comply with applicable requirements could harm our business
5. 35Our operations are subject to environmental, health, and safety regulations that could result in substantial costs
6. 36Healthcare policy changes may have a material adverse effect on us
7. 37We could be exposed to significant liability claims if we are unable to obtain insurance at acceptable costs and adequate levels or otherwise protect ourselves against potential product liability claims
8. 38We are subject to various United States and international bribery, anti-kickback, false claims, privacy, transparency, and similar laws, any breach of which could cause a material, adverse effect on our business, financial condition, and profitability
9. 39Tax laws, regulations, and enforcement practices are evolving and may have a material adverse effect on our results of operations, cash flows and financial position
10. 40We are subject to tax audits by various tax authorities in many jurisdictions

Risks Related to Intellectual Property

1. 41Our success depends on our ability to protect our intellectual property and our proprietary technology
2. 42Similarly, any know-how that is proprietary or particular to our technologies could be subject to risk of disclosure by employees or consultants despite having confidentiality agreements in place
3. 43Intellectual property rights of third parties could adversely affect our ability to commercialize our products
4. 44Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed
5. 45Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
6. 46Confidentiality and invention assignment agreements with our employees, advisors and consultants may not adequately prevent disclosure of trade secrets and protect other proprietary information
7. 47Intellectual property rights do not address all potential threats to our business prospects
8. 48Others may independently develop similar or alternative technologies or otherwise circumvent any of our technologies without infringing our intellectual property rights
9. 49Issued patents that we own may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors
10. 50Any difficulty with protecting our intellectual property could diminish the value of our intellectual property rights in the relevant jurisdiction
11. 51Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our products and any future products

Risks Related to Our Common Stock

1. 52Medtronic beneficially owns a significant equity interest in us and its interests may conflict with our or your interests
2. 53Our Common Stock is listed on Nasdaq, but the market price and trading volume of our Common Stock may be volatile and may be affected by economic conditions beyond our control
3. 54Shares of our Common Stock are listed to trade on Nasdaq in United States dollars and our CDIs are listed to trade on the ASX in Australian dollars, which may result in price variations
4. 55An active, liquid trading market for our Common Stock may not be maintained
5. 56We do not anticipate paying dividends in the foreseeable future
6. 57If United States securities or industry analysts do not publish research reports about our business, or if they issue an adverse opinion about our business, the market price and trading volume of our Common Stock could decline
7. 58We incur increased costs as a result of operating as a United States listed public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices, which could divert their attention from the operation of our business
8. 59The material weaknesses identified by our management and our independent auditors relate to (i) a lack of appropriately designed, implemented and documented procedures and controls, and (ii) deficiencies in the segregation of duties
9. 60Our Charter and Bylaws contain anti-takeover provisions that could delay or discourage takeover attempts that stockholders may consider favorable
10. 61Future equity financings and sales by existing holders could adversely affect the voting power or value of our Common Stock
11. 62Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our Common Stock
12. 63We are a holding company and, as such, we will depend on our subsidiaries to support our operations
13. 64Our ability to use our United States net operating loss carryforwards to offset future taxable income may be subject to certain limitations
14. 65As of December 31, 2025, we had Australian net operating and capital loss (“NOCL”) carryforwards of $74.5 million, which may be available to offset Australian income tax liabilities in the future. In addition, we may generate additional NOCLs in future years
15. 66The business continuity test considers whether ATPL has maintained a similar or same business at the relevant testing times
16. 67Sales of a substantial number of shares of our Common Stock in the public market by our existing stockholders could cause the price of our Common Stock to fall