CONMED (CNMD) risk factors, FY2025 10-K

CONMED's FY2025 10-K, filed Feb 17, 2026, lists 38 risk factors. Against the prior year's 34: 7 new, 3 dropped, 10 substantially reworded.

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Risk factors listed
380 groups
New this year
7vs 34 last year
Dropped
3since the prior 10-K
Substantially reworded
10of those kept
Section length
12k wordsItem 1A

What the changes say

  • CONMED added risks concerning AI adoption, divestitures, and healthcare compliance penalties.
  • Capital products yielded 14% of 2025 revenues, while international sales contributed 44%.
  • The company suspended its quarterly dividend in October 2025 and terminated its W.L. Gore & Associates distribution agreement in December 2025.

What changed since the prior 10-K

New

  • New

    economic conditions could also have material adverse effects on our business, financial condition or results of operations, even if our direct exposure to the affected region is limited. Global political trends could increase the probability of a deterioration in global economic conditions

    Approximately 14% of 2025 revenues came from capital products, which hospitals may defer purchasing if financing tightens.

  • New

    exclusion from government reimbursement programs and/or entry into Corporate Integrity Agreements with governmental agencies. In addition, resolution of any of these matters could involve the imposition of additional, costly compliance obligations

    Violations of broad healthcare regulations could lead to criminal penalties, fines, employee imprisonment, or exclusion from government programs.

  • New

    We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our reputation, subject us to significant fines and liability or otherwise adversely affect our business

    The federal Anti-Kickback Statute and other healthcare laws constrain business arrangements and impose ongoing compliance costs.

  • New

    If third-party payors decline to reimburse our customers for our products or reduce reimbursement levels, the demand for our products may decline and our ability to sell our products profitably may be harmed

    Third-party payors may deny reimbursement or reduce coverage for medical products, reducing customer demand.

  • New

    Our financial performance is subject to risks in connection with divestitures, and our failure to manage these divestitures could have a negative impact on our business

    Divesting product lines like gastroenterology may incur unexpected costs, liabilities, or difficulties in finding buyers.

  • New

    Our use of artificial intelligence (“AI”) and other emerging technologies could adversely impact our business and financial results

    Deploying artificial intelligence introduces potential content deficiencies, regulatory uncertainty, and cybersecurity risks.

  • New

    Our business may be damaged or disrupted as a result of natural or man-made disasters, or public health crises

    Natural disasters, man-made disasters, or public health crises could damage manufacturing facilities and disrupt the supply chain.

Dropped

  • Dropped

    Public health crises have had, and may continue to have, an adverse effect on certain aspects of our business, financial condition, or results of operations. The nature and extent of future impacts are highly uncertain and unpredictable

  • Dropped

    Moreover, we are generally required to obtain regulatory clearance or approval prior to marketing a new product. The time required to obtain approvals from foreign countries may be longer or shorter than that required for FDA clearance, and requirements for such approvals may differ from FDA requirements

  • Dropped

    Damage to our physical properties as a result of hurricanes, tornadoes, earthquakes, fires, droughts, extreme temperatures, flooding or other natural or man-made disaster may cause a financial loss and a loss of customers

    Uncertainty related to public health crises like COVID-19 restricting field sales travel.

Reworded

  • 85% rewritten

    Failure to comply with regulatory requirements may result in recalls, loss of revenues, fines or other materially adverse implications

    Added specific governing laws and regulations over product development, testing, classification, manufacturing, labeling, marketing, sale, and distribution.

  • 52% rewritten

    Limitations on the availability of Ethylene Oxide (“EtO”) sterilization services may limit our ability to sell certain sterile products

    Updated revenue percentage for products sterilized using Ethylene Oxide to 31% based on 2025 figures instead of 2024.

  • 48% rewritten

    Our financial performance is dependent on conditions in the healthcare industry and the broader economy. Our business and financial performance could be adversely affected, directly or indirectly, by a potential economic downturn

    Added explicit mention that adverse economic effects could impact business, financial condition, or results of operations.

  • 42% rewritten

    (iv) Other Risks Related to Our Business

    Retained substantially identical text regarding IT system failures and cybersecurity risks under the risk category.

  • 40% rewritten

    Our Board of Directors may, in the future, not approve payment of a dividend on common stock

    Disclosed that the Board of Directors suspended dividend payments in October 2025 and that the senior credit agreement now restricts dividend payments.

    Was: Our Board of Directors may, in the future, limit or discontinue payment of a dividend on common stock

  • 34% rewritten

    We distribute some products for third-party companies, and cannot ensure that our rights to distribute such third-party products will continue indefinitely

    Added a specific example disclosing the termination of the distribution agreement with W.L. Gore & Associates for the Gore VIABIL biliary stent in December 2025.

  • 33% rewritten

    Our significant international operations subject us to foreign currency fluctuations and other risks associated with operating in countries outside the U.S

    Updated international metrics showing 44% of 2025 consolidated net sales were outside the U.S., with export basis sales at 12%.

    Was: Our significant international operations subject us to foreign currency fluctuations and other risks associated with operating in countries outside the United States

  • 32% rewritten

    If we lose our patents or they are held to be invalid, or if our products or services infringe on third party patents, we could become subject to liability and our competitive position could be harmed

    Expanded intellectual property protections to include trademarks, tradenames, copyrights, trade secrets, and agreements, updating patent expiration dates to range from 2026 through 2043.

  • 28% rewritten

    With a global footprint and supply chain, our results and operations could be adversely affected by raw material shortages, inflation, price increases, economic or geopolitical developments, including protectionist trade policies such as tariffs, or other events

  • 22% rewritten

    The conditional conversion features of our 2.250% Notes if triggered, may adversely affect our financial condition

All 38 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01(i) Risks Related to Our Business and the Medical Device Industry
  2. 02Our financial performance is dependent on conditions in the healthcare industry and the broader economy. Our business and financial performance could be adversely affected, directly or indirectly, by a potential economic downturn48% rewritten
  3. 03economic conditions could also have material adverse effects on our business, financial condition or results of operations, even if our direct exposure to the affected region is limited. Global political trends could increase the probability of a deterioration in global economic conditionsNew
  4. 04Limitations on the availability of Ethylene Oxide (“EtO”) sterilization services may limit our ability to sell certain sterile products52% rewritten
  5. 05exclusion from government reimbursement programs and/or entry into Corporate Integrity Agreements with governmental agencies. In addition, resolution of any of these matters could involve the imposition of additional, costly compliance obligationsNew
  6. 06We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our reputation, subject us to significant fines and liability or otherwise adversely affect our businessNew
  7. 07Failure to comply with regulatory requirements may result in recalls, loss of revenues, fines or other materially adverse implications85% rewritten
  8. 08The highly competitive market for our products may create adverse pricing pressures
  9. 09If third-party payors decline to reimburse our customers for our products or reduce reimbursement levels, the demand for our products may decline and our ability to sell our products profitably may be harmedNew
  10. 10Cost reduction efforts in the healthcare industry could put pressures on our prices and margins
  11. 11With a global footprint and supply chain, our results and operations could be adversely affected by raw material shortages, inflation, price increases, economic or geopolitical developments, including protectionist trade policies such as tariffs, or other events28% rewritten
  12. 12We may not be able to keep pace with technological change or to successfully develop new products with wide market acceptance, which could cause us to lose business to competitors
  13. 13Ordering patterns of our customers may change resulting in reductions in sales
  14. 14The terms of our indebtedness outstanding from time to time, including our senior credit agreement, may restrict our current and future operations, particularly our ability to respond to changes or to take certain actions
  15. 15We may not be able to generate sufficient cash to service our indebtedness and other obligations, and, our leverage and debt service requirements may require us to adopt alternative business strategies
  16. 16Our variable rate indebtedness subjects us to interest rate risk, which could cause our debt service obligations to increase significantly
  17. 17Despite our current level of indebtedness, we and our subsidiaries may still be able to incur substantially more debt. This could further exacerbate the risks to our financial condition described above
  18. 18The conditional conversion features of our 2.250% Notes if triggered, may adversely affect our financial condition22% rewritten
  19. 19The convertible notes hedge and warrant transactions that we entered into in connection with the offering of the Convertible Notes may affect the value of the Convertible Notes and our common stock
  20. 20We are subject to counterparty risk with respect to the convertible notes hedge transactions
  21. 21The terms of any future preferred equity or debt financing may give holders of any preferred securities or debt securities rights that are senior to rights of our common shareholders or impose more stringent operating restrictions on our company
  22. 22Our financial performance is subject to the risks inherent in any acquisition, including the effects of increased borrowing and integration of newly acquired businesses or product lines
  23. 23Our financial performance is subject to risks in connection with divestitures, and our failure to manage these divestitures could have a negative impact on our businessNew
  24. 24(iv) Other Risks Related to Our Business42% rewritten
  25. 25Our use of artificial intelligence (“AI”) and other emerging technologies could adversely impact our business and financial resultsNew
  26. 26We rely on a third party to obtain, process and distribute sports medicine allograft tissue. If such tissue cannot be obtained, is not accepted by the market or is not compliant with applicable government regulations, our results of operations could be negatively impacted
  27. 27We distribute some products for third-party companies, and cannot ensure that our rights to distribute such third-party products will continue indefinitely34% rewritten
  28. 28If we lose our patents or they are held to be invalid, or if our products or services infringe on third party patents, we could become subject to liability and our competitive position could be harmed32% rewritten
  29. 29We may be sued for product liability claims and our insurance coverage may be insufficient to cover the nature and amount of any product liability claims
  30. 30Our business may be damaged or disrupted as a result of natural or man-made disasters, or public health crisesNew
  31. 31Our insurance coverage is limited to certain caps, and our insurance may not be adequate to cover future losses
  32. 32Our significant international operations subject us to foreign currency fluctuations and other risks associated with operating in countries outside the U.S33% rewritten
  33. 33Our new products may fail to achieve expected levels of market acceptance
  34. 34If our new products do not achieve market acceptance, we may be unable to recover our investments and may lose business to competitors
  35. 35Our Board of Directors may, in the future, not approve payment of a dividend on common stock40% rewritten
  36. 36Anti-takeover provisions in our organizational documents and Delaware law could delay or prevent a change in control
  37. 37Violations of environmental, social and governance laws and regulations and climate change initiatives could materially and adversely affect our business, financial condition, and results of operations
  38. 38Our ability to attract and retain qualified employees is critical to our success

Other CONMED 10-Ks

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.