Merit Medical Systems (MMSI) risk factors, FY2024 10-K

Business, Economic, Industry and Operational Risks

1. 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 condition
2. 02Changes 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
3. 03Volatile geopolitical turmoil, including popular uprisings, regional conflicts, terrorism and war could result in market instability, which could negatively impact our business results
4. 04Any 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
5. 05Consolidation 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
6. 06We may be unable to compete in our markets, particularly if there is a significant change in practices or technology
7. 07We may be unable to successfully manage growth
8. 08We 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
9. 09Failure to realize the benefits expected from recent acquisitions could adversely affect our business, operating results and financial condition
10. 10If we fail to achieve anticipated 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
11. 11Our 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
12. 12We may be unable to accurately forecast customer demand for our products and manage our inventory
13. 13Our reliance on third-party distributors in many countries could negatively impact the commercialization of our products in those countries
14. 14If 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

Regulatory, Litigation, Tax and Legal Compliance Risks

1. 15The 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
2. 16Unsuccessful pre- and post-market clinical trials relating to our products could have a material adverse effect on our prospects
3. 17We 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
4. 18Limits on reimbursement imposed by governmental and other programs may adversely affect our business and results of operation
5. 19Use of our products in unapproved circumstances could expose us to liabilities
6. 20Our products may be subject to product liability claims and warranty claims
7. 21Our employees, independent contractors, consultants, manufacturers and distributors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
8. 22We are routinely a party to litigation, which could affect our financial condition and results of operations
9. 23We 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
10. 24Our failure to comply with applicable environmental, health and safety laws and regulations could negatively affect our business, operations or financial condition
11. 25We could be negatively impacted by corporate social responsibility laws, regulations, practices and expectations
12. 26Our business and operations are subject to risks related to climate change
13. 27We may not be able to protect our intellectual property, which could harm our business and financial condition
14. 28Third 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
15. 29We 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

Market, Liquidity and Credit Risks

1. 30The 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
2. 31executed 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
3. 32Our management has broad discretion regarding the use of proceeds of the Convertible Notes and other borrowed funds
4. 33We may not be able to service all of our indebtedness
5. 34The fundamental change repurchase feature of the Convertible Notes may delay or prevent an otherwise beneficial attempt to acquire us
6. 35The market price of our common stock has been and may continue to be volatile
7. 36Fluctuations in foreign currency exchange rates may negatively impact our financial results