Integra Lifesciences Holdings (IART) risk factors, FY2024 10-K

Other

1. 01The continuing worldwide macroeconomic and geopolitical uncertainty may adversely affect our business and prospects

RISKS RELATING TO OUR BUSINESS

1. 02Our operating results may fluctuate
2. 03The industry and market segments in which we operate are highly competitive, and we may be unable to compete effectively with other companies
3. 04Changes in the healthcare industry may require us to decrease the selling price for our products, may reduce the size of the market for our products, or may eliminate a market, any of which could have a negative impact on our financial performance
4. 05Any and all of the above factors could materially and adversely affect our levels of revenue and our profitability
5. 06Matrix for total consideration of $45.0 million. These acquisitions added products to our plastic and reconstructive surgery, ENT, neurosurgery and complex wound management product portfolios and provides additional growth opportunities for our TT segment
6. 07A significant portion of our current operations are conducted and located outside the United States, and our growth strategy involves expanding our existing foreign operations and entering into new foreign jurisdictions. We have significant manufacturing and distribution sites in North America, Europe, China and Japan
7. 08Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results
8. 09Exchange rate fluctuations and foreign currency hedges could adversely affect our financial results
9. 10Our future financial results could be adversely affected by impairments or other charges
10. 11The guidance on long-lived assets requires that we assess the impairment of our long-lived assets, including finite-lived intangible assets, whenever events or changes in circumstances indicate that the carrying value may not be recoverable as measured by the sum of the expected future undiscounted cash flows
11. 12Lack of market acceptance for our products or market preference for technologies that compete with our products could reduce our revenues and profitability
12. 13It could be difficult to replace some of our suppliers
13. 14The availability of amniotic tissue-based products depends upon, among other factors, the availability of tissue from human donors. Access to donated amniotic tissue could also be adversely impacted by regulatory changes or evolving public perceptions of the donor process
14. 15We may experience difficulties, delays, performance impact or unexpected costs from consolidation of facilities and transfer of manufacturing facilities
15. 16If any of our facilities or those of our suppliers were damaged and/or our manufacturing or business processes interrupted, we could experience lost revenues and our business could be seriously harmed
16. 17We may have significant product liability exposure and our insurance may not cover all potential claims
17. 18Our private label product lines depend significantly on key relationships with third parties, which we could be unable to establish and maintain

RISKS RELATED TO OUR REGULATORY ENVIRONMENT

1. 19We are subject to stringent domestic and foreign medical device regulations and oversight and any adverse action may adversely affect our ability to compete in the marketplace and our financial condition and business operations
2. 20Some of our activities may subject us to risks under federal and state laws prohibiting “kickbacks” and false or fraudulent claims
3. 21Our medical device products are subject to reporting requirements and recalls, even after receiving regulatory clearance, approval or certification, which could harm our reputation, business and financial results
4. 22The adoption of healthcare reform in the U.S. and initiatives sponsored by other governments may adversely affect our business, results of operations and/or financial condition
5. 23Certain of our products contain materials derived from animal sources and may become subject to additional regulation
6. 24We are subject to current and potential future requirements relating to protection of the environment, such as hazardous materials regulations, which may impose significant compliance or other costs on us
7. 25Our business and operations are subject to risks related to climate change
8. 26Environmental, social and corporate governance (ESG) issues, including those related to climate change and sustainability, may have an adverse effect on our business, financial condition and results of operations and damage our reputation
9. 27If we do not retain our key personnel and attract and retain other highly skilled employees, our business could suffer

RISKS RELATED TO TAX AND DEBT

1. 28We may have additional tax liabilities
2. 29Changes in tax laws or exposures to additional tax liabilities could negatively impact the Company's operating results
3. 30Our leverage and debt service obligations could adversely affect our business

RISKS RELATED TO OUR INTELLECTUAL PROPERTY

1. 31Our intellectual property rights may not provide meaningful commercial protection for our products, potentially enabling third parties to use our technology or very similar technology and could reduce our ability to compete in the market
2. 32Our competitive position depends, in part, upon unpatented trade secrets, which we may be unable to protect
3. 33Our success will depend partly on our ability to operate without infringing or misappropriating the proprietary rights of others
4. 34We may be involved in lawsuits relating to our intellectual property rights and promotional practices, which may be expensive

RISKS RELATED TO CYBERSECURITY AND DATA PRIVACY

1. 35Cybersecurity incidents or other disruptions to our information technology systems could adversely affect our business
2. 36Failure to comply with laws relating to the confidentiality of sensitive personal information or standards related to the transmission of electronic health data, may require us to make significant changes to our products, or incur penalties or other liabilities