Enovis (ENOV) risk factors, FY2025 10-K

Risks Related to Our Business and Operations

1. 01Our indebtedness could adversely affect our financial condition and restricts us in ways that limit our flexibility in operating our business
2. 02Our restructuring activities may subject us to additional uncertainty in our operating results
3. 03Any further impairment in the value of our intangible assets, including Goodwill, would negatively affect our operating results and total capitalization55% rewritten
4. 04A material disruption at any of our manufacturing facilities could adversely affect our ability to generate sales and meet customer demand
5. 05Failure to maintain and protect our intellectual property rights or challenges to these rights by third parties may affect our operations and financial performance
6. 06Risks relating to contagious diseases, terrorist activity, man-made or natural disasters and war have adversely impacted, and may, either alone or in combination with other risks, in the future have an adverse effect on our results of operations, financial condition, and businessNew
7. 07Significant movements in foreign currency exchange rates may harm our financial results
8. 08We are dependent on the availability of raw materials, as well as parts and components used in our products
9. 09We are vulnerable to raw material, energy and labor price fluctuations and supply shortages, which have impacted and could continue to impact our results of operations, financial condition and cash flows
10. 10The markets we serve are highly competitive and some of our competitors may have superior resources. If we are unable to respond successfully to this competition, this could reduce our sales and operating margins
11. 11Changes in our tax rates or exposure to additional income tax liabilities could adversely affect our financial results
12. 12We rely on a variety of distribution methods to market and sell our medical device products and if we fail to effectively manage the distribution of such products, our results of operations and future growth could be adversely impacted

Risks Related to Government Regulation and Litigation

1. 13process of obtaining regulatory clearances or approvals to market a medical device can be costly and time consuming, and we may not be able to obtain these clearances or approvals on a timely basis, if at allNew
2. 14Tariffs and other trade measures could adversely affect our business, results of operations, financial position and cash flows32% rewritten
3. 15Modifications to our products may require new regulatory clearances or approvals in the United States and EU or may require us to recall or cease marketing our products until clearances or approvals are obtained
4. 16Obtaining new clearances and approvals can be a time-consuming process, and delays in obtaining required future clearances or approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which could harm our future growth
5. 17Our products must be manufactured in accordance with federal and state regulations, and we could be forced to recall our devices or terminate production if we fail to comply with these regulations
6. 18We may be subject to regulatory or enforcement actions if we engage in improper marketing or promotion of our products
7. 19Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of any future products and to manufacture, market and distribute our products after clearance or approval is obtained
8. 20The results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects
9. 21Our medical device businesses subject us to the possibility of product liability lawsuits, which could harm our business
10. 22If coverage and adequate levels of reimbursement from third-party payors for our medical device products are not obtained, healthcare providers and patients may be reluctant to use our medical device products, our margins may suffer and revenue and profits may decline
11. 23Audits or denials of claims by government agencies could reduce our revenues or profits
12. 24Federal and state health reform and cost control efforts could adversely impact our business and results of operations, and federal and state legislatures and agencies continue to consider further reforms and cost control efforts that could adversely impact our business and results of operations
13. 25The success of our surgical implant products depends on our relationships with leading surgeons who assist with the development and testing of our products, and our ability to comply with enhanced disclosure requirements regarding payments to physicians
14. 26Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations and financial condition53% rewritten
15. 27Our information technology infrastructure and information are vulnerable to service interruptions, data corruption, cyber-based attacks, or network security breaches32% rewritten
16. 28Our use of artificial intelligence and machine‑learning technologies may expose us to operational, regulatory, and reputational risksNew
17. 29We are subject to anti-bribery laws such as the U.S. Foreign Corrupt Practices Act as well as export controls, economic sanctions, and other trade laws, the violation of which could lead to serious adverse consequences
18. 30The risk of non-compliance with non-U.S. laws, regulations and policies could adversely affect our results of operations, financial condition or strategic objectives

Risks Related to the Separation

1. 31We could incur significant liability if the separation and distribution of ESAB Corporation is determined to be a taxable transaction
2. 32Potential indemnification liabilities to ESAB pursuant to the separation agreement could materially and adversely affect our businesses, financial condition, results of operations and cash flows

General Risk Factors and Other Risks

1. 33Changes in the general economy could negatively impact the demand for our products and services and harm our operations and financial performance
2. 34Our business, financial condition and results of operations could be adversely affected by disruptions in the global economy caused by geopolitical uncertainty, political instability, and conflicts, such as the armed conflicts between Russia and Ukraine and in the Middle EastNew
3. 35The loss of key leadership or the inability to attract, develop, engage, and retain qualified employees could have a material adverse effect on our ability to run our business
4. 36The issuances of additional common and preferred stock may adversely affect the market price of our Common stock
5. 37Provisions in our governing documents and Delaware law may delay or prevent an acquisition of Enovis that may be beneficial to our stockholders