Mimedx Group (MDXG) risk factors, FY2025 10-K

Risks Related to Our Business and Industry

1. 01If we do not successfully execute our priorities, our business, operating results and financial condition could be adversely affected
2. 02We are in a highly competitive and evolving field and face competition from well-established tissue processors and medical device manufacturers, as well as new market entrants
3. 03Rapid technological change could cause our products to become obsolete and, if we do not enhance our product offerings through our research and development efforts or business development and inorganic activities, we may be unable to compete effectively
4. 04Many of our products depend on the availability of tissue from human donors, and any disruption in supply could adversely affect our business
5. 05Our business and success are materially dependent on attracting and retaining members of our senior leadership team to formulate and execute the Company’s business plans and our sales team to market our products
6. 06Our revenues depend on adequate reimbursement from public and private insurers and health systems and changes to the ways in which our products are reimbursed in various sites of service could adversely impact our financial results100% rewritten
7. 07Our revenue, results of operations and cash flows may suffer upon the loss of a Group Purchasing Organization or Integrated Delivery Network23% rewritten
8. 08We contract with and are dependent upon independent sales agents and distributors
9. 09Disruption of our processing facilities could adversely affect our business, financial condition and results of operations38% rewritten
10. 10To be commercially successful, we must educate physicians, where appropriate, how and when our products are proper alternatives to existing treatments and that our products should be used in their procedures29% rewritten
11. 11If we cannot successfully address quality issues that may arise with our products, our brand reputation could suffer, and our business, financial condition, and results of operations could be adversely impacted
12. 12The formation of physician-owned distributorships (“PODs”) could result in increased pricing pressure on our products or harm our ability to sell our products to physicians who own or are affiliated with those distributorships
13. 13We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance
14. 14The products we offer are derived from human and animal tissue and therefore have the potential for disease transmission
15. 15We may implement a product recall or voluntary market withdrawal, which could significantly increase our costs, damage our reputation, disrupt our business and adversely affect our business, results of operations and financial condition
16. 16A cyberattack or significant disruptions of our information technology systems could adversely affect our business, results of operation and financial condition
17. 17Increased use of artificial intelligence (“AI”) and related technologies in the medical device industry could subject us to new risks and uncertainties, and our failure to effectively evaluate or adopt such technologies could adversely affect our businessNew
18. 18we adopt AI without appropriate governance, controls, or expertise, we could incur increased costs, operational disruptions, or reputational harmNew
19. 19We may expand or contract our business through acquisitions, divestitures, licenses, investments, and other commercial arrangements with other companies or technologies, which may adversely affect our business, results of operations and financial condition
20. 20A portion of our revenues and accounts receivable come from government accounts24% rewritten
21. 21New lines of business or new products and services may subject us to additional risks
22. 22Our international expansion and operations outside the U.S. expose us to risks associated with international sales and operations

Risks Related to Regulatory Approval of Our Products and Other Government Regulations

1. 23HELIOGEN, our first xenograft product offering, falls into an FDA classification that requires the submission of a Premarket Notification (510(k)) to the FDA. The 510(k) was obtained and is owned by our contracted manufacturing partner, Regenity Biosciences
2. 24Obtaining and maintaining the necessary regulatory approvals, including conducting clinical trials, for certain of our products or potential products could be expensive and time consuming
3. 25Our business is subject to extensive regulation by the FDA and other authorities, which is costly, and our failure to comply could result in negative effects on our business, results of operations and financial condition
4. 26The FDA’s regulation of HCT/Ps may continue to evolve. Complying with any such new regulatory requirements may entail significant time delays and expense, which could have an adverse effect on our business, results of operations and financial condition
5. 27We may be subject to fines, penalties, injunctions and other sanctions if we are deemed to be promoting the use of our products for unapproved, or off-label, uses
6. 28We and our sales representatives, whether employees or independent contractors, must comply with various federal and state anti-kickback, self-referral, false claims and similar laws, any breach of which could cause an adverse effect on our business, results of operations and financial condition90% rewritten
7. 29Our results of operations may be adversely affected by current and potential future healthcare reforms62% rewritten
8. 30We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries
9. 31Federal and state laws that protect the privacy and security of personal information may increase our costs and limit our ability to collect and use that information and subject us to liability if we are unable to fully comply with such laws

Risks Related to Our Intellectual Property

1. 32Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain and may be inadequate, which could have an adverse effect on our business, results of operations and financial condition60% rewritten
2. 33patent claims would be upheld. If any of those patent claims are invalidated or determined to be unenforceable, our competitive advantage may be reduced or eliminatedNew
3. 34We may become subject to claims of infringement of the intellectual property rights of others, which could prohibit us from developing our products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages
4. 35We may be subject to damages resulting from claims that we, our employees, or our independent contractors have wrongfully used or disclosed alleged trade secrets, proprietary or confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors

Risks Related to Our Consolidated Financial Statements, Internal Controls and Related Matters

1. 36If we fail to maintain adequate internal control over financial reporting in the future, this could adversely affect our business, financial condition and operating results

Risks Related to the Securities Markets and Ownership of Our Common Stock

1. 37Our indebtedness may adversely affect our financial health25% rewritten
2. 38The restrictive covenants in the Citizens Credit Agreement, and the Company’s obligation to make payments under the Citizens Credit Agreement, limit our operating and financial flexibility and may adversely affect our business, results of operations and financial condition
3. 39EW Healthcare Partners and its interests may conflict with those of our other shareholders29% rewritten
4. 40The price of our Common Stock has been, and will likely continue to be, volatile
5. 41Securities analysts may elect not to report on our common stock or may issue negative reports that adversely affect the stock price
6. 42Fluctuations in revenue or results of operations could cause additional volatility in our stock price
7. 43We do not intend to pay cash dividends on our Common Stock43% rewritten
8. 44Our capital allocation decisions, including decisions regarding share repurchases, investments in inorganic opportunities, and other capital allocation activities, may not achieve their intended benefits and could adversely affect our financial condition and stock priceNew
9. 45In February 2026, our Board authorized us to periodically repurchase up to $100.0 million of our common shares (the “Share Repurchase Plan” through February 2028. The Share Repurchase Plan does not obligate the Company to repurchase any number of shares and may be suspended or discontinued at any timeNew
10. 46Certain provisions of Florida 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 shareholders, which could affect our share price adversely and prevent attempts by shareholders to remove current management