What the changes say
- Merit Medical highlights new tariff risks from Mexico, Ireland, and China affecting raw material and component costs.
What changed since the prior 10-K
New
- NewBusiness, Economic, Industry and Operational Risks
Cost volatility could adversely affect our operations
Elevated commodity, supply chain, and oil-based resin costs increased our production and distribution expenses during 2025.
- NewBusiness, Economic, Industry and Operational Risks
trade ecosystems among our customers, partners, and us. Non-compliance with sanctions, as well as general ecosystem disruptions, could result in reputational harm, operational delays, monetary fines, lost revenues, increased costs, lost export privileges or criminal sanctions
U.S. government tariff policy changes on imports from Mexico, Ireland, and China have increased our manufacturing costs.
- NewRegulatory, Litigation, Tax and Legal Compliance Risks
The medical device industry is subject to extensive scrutiny and regulation by governmental and other authorities. If governmental authorities determine that we have violated laws or regulations, our company or our employees may be subject to various penalties, including civil or criminal penalties
FDA and international regulatory scrutiny of the medical device industry exposes us to potential subpoenas, fines, and manufacturing suspensions.
- NewMarket, Liquidity and Credit Risks
able to borrow up to $697 million in additional funds, which could result in total indebtedness under the Convertible Notes and Amended Fourth A&R Credit Agreement of up to $1,444.5 million
We could incur up to $1,444.5 million in total indebtedness under our Convertible Notes and Amended Credit Agreement.
Dropped
- DroppedBusiness, Economic, Industry and Operational Risks
We may be unable to successfully manage growth
- DroppedMarket, Liquidity and Credit Risks
executed an amendment to the Fourth A&R Credit Agreement (as amended, the "Amended Fourth A&R Credit Agreement”) to facilitate the issuance of our Convertible Notes described below
Reworded
- 92% rewrittenMarket, Liquidity and Credit Risks
The agreements and instruments governing our debt contain restrictions and limitations that could significantly affect our ability to operate our business, as well as significantly affect our liquidity
Updated to reflect that covenant breaches could affect liquidity and our ability to fund capital expenditures and ongoing operations.
- 86% rewrittenMarket, Liquidity and Credit Risks
We may not be able to service all of our indebtedness
Updated debt figures and borrowing capacity references to the year ended December 31, 2025.
- 86% rewrittenBusiness, Economic, Industry and Operational Risks
Changes in economic and geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business, operations or financial condition
Added Venezuela to the list of geopolitical tension areas alongside Ukraine, the Middle East, and China-Taiwan relations.
Was: Changes in economic and geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business, operations and financial condition
- 69% rewrittenRegulatory, Litigation, Tax and Legal Compliance Risks
Unsuccessful pre- and post-market clinical trials relating to our products could have a material adverse effect on our prospects
Removed references to trial enrollment uncertainty regarding therapeutic product clinical trials.
- 61% rewrittenBusiness, Economic, Industry and Operational Risks
If we are unable to effectively execute our leadership succession plans and attract, develop and retain key employees, our business or results of operations could be harmed
Disclosed the actual CEO transition where Martha G. Aronson replaced Fred Lampropoulos in October 2025.
Was: If we are unable to effectively execute our leadership succession plans and attract, develop and retain key employees, our business and results of operations could be harmed
- 59% rewrittenBusiness, Economic, Industry and Operational Risks
Consolidation in the healthcare industry, group purchasing organizations and public cost-containment measures have led to demands for price concessions with respect to our products, which may reduce our revenues and harm our ability to sell our products at prices necessary to support our current business strategies
Removed mention of additional liability required by lower pricing and favorable terms granted to group purchasing organizations.
Was: Consolidation in the healthcare industry, group purchasing organizations and public cost-containment measures have led to demands for price concessions, which may reduce our revenues and harm our ability to sell our products at prices necessary to support our current business strategies
- 56% rewrittenBusiness, Economic, Industry and Operational Risks
Disruptions in the supply from third-party vendors of the materials and components used in manufacturing or sterilizing our products could adversely affect our business, operations or financial condition
Added tariffs and related measures as well as sterilization service provider disruptions to third-party vendor supply risks.
- 50% rewrittenBusiness, Economic, Industry and Operational Risks
We may be unable to compete in our markets, particularly if there is a significant change in practices or technology
Made minor phrasing adjustments regarding our ability to compete and respond to technological changes.
- 42% rewrittenBusiness, Economic, Industry and Operational Risks
Volatile geopolitical turmoil, including popular uprisings, regional conflicts, terrorism and war could result in market instability, which could negatively impact our financial results
Was: Volatile geopolitical turmoil, including popular uprisings, regional conflicts, terrorism and war could result in market instability, which could negatively impact our business results
- 42% rewrittenBusiness, Economic, Industry and Operational Risks
Failure to realize the benefits expected from recent acquisitions could adversely affect our business, operating results or financial condition
Was: Failure to realize the benefits expected from recent acquisitions could adversely affect our business, operating results and financial condition
- 35% rewrittenBusiness, Economic, Industry and Operational Risks
Our future growth is dependent in part upon the development of new products and the enhancement of existing products, and there can be no assurance that such products be developed or enhanced
- 29% rewrittenRegulatory, Litigation, Tax and Legal Compliance Risks
Third parties claiming that we infringe their intellectual property rights could cause us to incur significant legal or licensing expenses and prevent us from selling our products
- 26% rewrittenRegulatory, Litigation, Tax and Legal Compliance Risks
We rely on the proper function, availability and security of information technology systems to operate our business, and a material disruption of critical information systems or a material breach in the security of our systems may adversely affect our business, reputation or financial condition
Was: We rely on the proper function, availability and security of information technology systems to operate our business, and a material disruption of critical information systems or a material breach in the security of our systems may adversely affect our business, reputation and financial condition
- 25% rewrittenRegulatory, Litigation, Tax and Legal Compliance Risks
Limits on reimbursement imposed by governmental and other programs may adversely affect our business and results of operation
- 24% rewrittenMarket, Liquidity and Credit Risks
Fluctuations in foreign currency exchange rates may negatively impact our financial results
- 22% rewrittenRegulatory, Litigation, Tax and Legal Compliance Risks
Our business and operations are subject to risks related to climate change
All 38 risk factors
Headings as the filing states them, in filing order.
Business, Economic, Industry and Operational Risks
- 01Disruptions in the supply from third-party vendors of the materials and components used in manufacturing or sterilizing our products could adversely affect our business, operations or financial condition56% rewritten
- 02Cost volatility could adversely affect our operationsNew
- 03Changes in economic and geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may adversely impact our business, operations or financial condition86% rewritten
- 04trade ecosystems among our customers, partners, and us. Non-compliance with sanctions, as well as general ecosystem disruptions, could result in reputational harm, operational delays, monetary fines, lost revenues, increased costs, lost export privileges or criminal sanctionsNew
- 05Volatile geopolitical turmoil, including popular uprisings, regional conflicts, terrorism and war could result in market instability, which could negatively impact our financial results42% rewritten
- 06Any damage or interruption to our operations, facilities, manufacturing processes or information technology systems, or those of our suppliers, could have an adverse effect on our business, operations or financial condition
- 07Consolidation in the healthcare industry, group purchasing organizations and public cost-containment measures have led to demands for price concessions with respect to our products, which may reduce our revenues and harm our ability to sell our products at prices necessary to support our current business strategies59% rewritten
- 08We may be unable to compete in our markets, particularly if there is a significant change in practices or technology50% rewritten
- 09We may incur substantial costs when evaluating, negotiating and closing acquisitions, and our failure to integrate acquired businesses may adversely impact our business and financial results
- 10Failure to realize the benefits expected from recent acquisitions could adversely affect our business, operating results or financial condition42% rewritten
- 11If we fail to achieve projected benefits from business acquisitions or strategic investments or identify underperforming products, we may dispose of the acquired or underperforming assets, which could adversely affect our results of operations
- 12Our future growth is dependent in part upon the development of new products and the enhancement of existing products, and there can be no assurance that such products be developed or enhanced35% rewritten
- 13We may be unable to accurately forecast customer demand for our products and manage our inventory
- 14Our reliance on third-party distributors could negatively impact the commercialization of our products
- 15If we are unable to effectively execute our leadership succession plans and attract, develop and retain key employees, our business or results of operations could be harmed61% rewritten
Regulatory, Litigation, Tax and Legal Compliance Risks
- 16The FDA regulatory clearance process is extensive and dynamic, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products
- 17Unsuccessful pre- and post-market clinical trials relating to our products could have a material adverse effect on our prospects69% rewritten
- 18The medical device industry is subject to extensive scrutiny and regulation by governmental and other authorities. If governmental authorities determine that we have violated laws or regulations, our company or our employees may be subject to various penalties, including civil or criminal penaltiesNew
- 19We are subject to laws targeting fraud and abuse in the healthcare industry, the violation of which could adversely affect our business, operations or financial condition
- 20Limits on reimbursement imposed by governmental and other programs may adversely affect our business and results of operation25% rewritten
- 21Use of our products in unapproved circumstances could expose us to liabilities
- 22Our products may be subject to product liability claims and warranty claims
- 23Our employees, independent contractors, consultants, manufacturers and distributors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
- 24We are routinely a party to litigation, which could affect our financial condition and results of operations
- 25We are subject to changes in tax laws, fluctuations in tax rates, the adoption of new tax legislation or exposure to additional tax liabilities, which may adversely affect our effective tax rate, business, financial condition, or results of operations
- 26Our failure to comply with applicable environmental, health and safety laws and regulations could negatively affect our business, operations or financial condition
- 27We could be negatively impacted by corporate social responsibility laws, regulations, practices and expectations
- 28Our business and operations are subject to risks related to climate change22% rewritten
- 29We may not be able to protect our intellectual property, which could harm our business and financial condition
- 30Third parties claiming that we infringe their intellectual property rights could cause us to incur significant legal or licensing expenses and prevent us from selling our products29% rewritten
- 31We rely on the proper function, availability and security of information technology systems to operate our business, and a material disruption of critical information systems or a material breach in the security of our systems may adversely affect our business, reputation or financial condition26% rewritten
Market, Liquidity and Credit Risks
- 32The agreements and instruments governing our debt contain restrictions and limitations that could significantly affect our ability to operate our business, as well as significantly affect our liquidity92% rewritten
- 33Our management has broad discretion regarding the use of proceeds of the Convertible Notes and other borrowed funds
- 34We may not be able to service all of our indebtedness86% rewritten
- 35able to borrow up to $697 million in additional funds, which could result in total indebtedness under the Convertible Notes and Amended Fourth A&R Credit Agreement of up to $1,444.5 millionNew
- 36The fundamental change repurchase feature of the Convertible Notes may delay or prevent an otherwise beneficial attempt to acquire us
- 37The market price of our common stock has been and may continue to be volatile
- 38Fluctuations in foreign currency exchange rates may negatively impact our financial results24% rewritten
Other Merit Medical Systems 10-Ks
- FY2024 10-K risk factors36 risks
Merit Medical faces heavy operational risk from third-party supply chain dependencies and rigorous FDA regulations. Financial leverage is high with $747.5 million in total outstanding indebtedness. Strategic reliance on acquisitions and international distribution networks creates significant integration exposure.
Filed Feb 25, 2025
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.