Artivion (AORT) risk factors, FY2025 10-K

Business and Economic Risks

1. 01We are subject to a variety of risks due to our international operations and continued global expansion23% rewritten
2. 02We operate in highly competitive market segments, face competition from large, well-established medical device companies and tissue service providers with greater resources and we may not be able to compete effectively
3. 03We are significantly dependent on our revenues from tissue preservation services and are subject to a variety of risks affecting them28% rewritten
4. 04We are significantly dependent on our revenues from BioGlue and are subject to a variety of related risks
5. 05We are significantly dependent on our revenues from aortic stent grafts and are subject to a variety of related risks
6. 06We are significantly dependent on our revenues from On-X products and are subject to a variety of related risks
7. 07Continued fluctuation of foreign currencies relative to the US Dollar could materially, adversely affect our business
8. 08Some of our products and technologies are subject to significant intellectual property risks and uncertainty
9. 09Public health crises have, may continue to have, and could have a material, adverse impact on us

Operational Risks

1. 10We are heavily dependent on our suppliers and contract manufacturers to provide quality products
2. 11We are dependent on single and sole-source suppliers and single facilities
3. 12We are dependent on our specialized workforce
4. 13We continue to evaluate expansion through acquisitions of, or licenses with, investments in, and distribution arrangements with, other companies or technologies, which may carry significant risks
5. 14Our charges resulting from acquisitions, divestitures, partnerships, and other business development activities may materially, adversely affect the market value of our common stock
6. 15We may not realize all the anticipated benefits of our business development activities
7. 16Significant disruptions of information technology systems or breaches of information security systems could adversely affect our business
8. 17Our business could be impacted by environmental, workforce, and governance-related matters62% rewritten

Legal, Quality, and Regulatory Risks

1. 18Our products and tissues are highly regulated and subject to significant quality and regulatory risks
2. 19Reclassification by the FDA of CryoValve SG pulmonary heart valve (“CryoValve SGPV”) may make it commercially infeasible to continue processing the CryoValve SGPV
3. 20We may not be successful in obtaining clinical results or regulatory clearances/approvals for new and existing products and services, and our approved products and services may not achieve market acceptance
4. 21Each of our trials, studies, and approvals is subject to the risks outlined herein
5. 22Increased environmental regulations and private litigation activity relating to processes and materials used in our industry could have a material, adverse impact on us
6. 23In addition, any litigation, regulatory enforcement, or government regulation regarding the use of EtO could result in financial, legal, business, and reputational harm to us
7. 24We may be subject to fines, penalties, and other sanctions if we are deemed to be promoting the use of our products for unapproved, or off-label, uses
8. 25We are subject to various US 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. 26United States policy changes may have a material, adverse effect on us29% rewritten
10. 27As a medical device manufacturer and tissue services provider we are exposed to risk of product liability claims and our existing insurance coverage may be insufficient, or we may be unable to obtain insurance in the future, to cover any resulting liability
11. 28Failure to comply with data privacy and security laws could have a material adverse effect on our business
12. 29Recent healthcare and tax legislation could have a material adverse effect on our businessNew

Risks Relating to Our Indebtedness

1. 30The agreements governing our indebtedness contain restrictions that limit our flexibility in operating our business
2. 31Our indebtedness could adversely affect our ability to raise additional capital to fund operations and execute our strategic plan and limit our ability to react to changes in the economy or our industry

Risks Relating to Ownership of our Common Stock

1. 32Our business could be negatively impacted as a result of stockholder activism
2. 33We do not anticipate paying any dividends on our common stock for the foreseeable future
3. 34Provisions of Delaware law and anti-takeover provisions in our organizational documents may discourage or prevent a change of control, even if an acquisition would be beneficial to stockholders, which could affect our share price adversely and prevent attempts by stockholders to remove current management