InfuSystem Holdings (INFU) risk factors, FY2025 10-K

Other

1. 01Any change in the overall healthcare reimbursement system may adversely impact our business
2. 02Our business is substantially dependent on estimates of collectible revenue from third-party reimbursement68% rewritten
3. 03The loss of a relationship with one or more third-party payers could negatively impact our business35% rewritten
4. 04Any federal government shutdown may adversely impact our business86% rewritten
5. 05Payer concentration may adversely impact our business
6. 06Increased focus on early detection and diagnostics may adversely affect our business
7. 07If future clinical studies demonstrate that oral medications or other therapies that do not use our electronic ambulatory pumps are at least as effective as continuous infusion therapy, our business could be adversely affected
8. 08Our success is impacted by the availability of the chemotherapy drugs that are used in our continuous infusion pump systems
9. 09We are dependent on our Medicare Supplier Number
10. 10The impact of actual or perceived U.S. healthcare reform legislation on us remains uncertain41% rewritten
11. 11administration has also changed the composition of, and guidance from, advisory panels on healthcare practices and government enforcementNew
12. 12We rely on independent suppliers for our products. Any delay or disruption in the supply of products, particularly our supply of electronic ambulatory pumps, may negatively impact our operations
13. 13We face periodic reviews and billing audits from governmental and private payers and these audits could have adverse results that may negatively impact our business
14. 14Our failure to maintain controls and processes over billing and collecting could have a negative impact on our Consolidated Financial Statements
15. 15State licensure laws for Durable Medical Equipment suppliers are subject to change. If we fail to comply with any state laws, we will be unable to operate as a Durable Medical Equipment supplier in such state and our business operations will be adversely affected
16. 16Our customer concessions may not be adequate to cover actual losses
17. 17Our growth strategy includes expanding into treatment for cancers other than colorectal cancer. There can be no assurance that continuous infusion-based regimens for these other cancers will become standards of care for large numbers of patients or that we will be successful in penetrating these different markets
18. 18The industry in which we operate is intensely competitive and ever-changing. If we are unable to successfully compete with our competitors, our business operations may suffer
19. 19Our industry is dependent on regulatory guidelines that affect our billing practices. If our competitors do not comply with these regulatory guidelines, our business could be adversely affected
20. 20Although we do not manufacture the products we distribute, if one of the products distributed by us proves to be defective or is misused by a healthcare practitioner or patient, we may be subject to liability that could adversely affect our financial condition and results of operations
21. 21We have in the past, and in the future intend to pursue growth opportunities through strategic alliances, joint ventures and strategic acquisitions, which may divert our management's attention, and we may be unable to achieve the expected benefits of such alliances, joint ventures or acquisitions
22. 22If we are unable to support increased operations or personnel, our future growth and business could suffer
23. 23We may be unable to maintain adequate working relationships with healthcare professionals
24. 24If we fail to comply with applicable governmental or accrediting bodies’ regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected41% rewritten
25. 25the privacy and security of health information in certain circumstances, many of which differ in significant ways from state to state and often are not preempted by HIPAA, thus complicating compliance effortsNew
26. 26Failure to protect our intellectual property could substantially harm our business and operating results
27. 27Covenants in our current and any future debt agreements restrict our business23% rewritten
28. 28Economic uncertainty or deterioration or geopolitical instability could adversely affect us23% rewritten
29. 29Changes in tax laws or challenges to our tax positions could adversely affect our business, results of operations and financial condition43% rewritten
30. 30The value of our net operating loss carryforwards may become impaired if we do not generate sufficient future taxable income required to utilize all or a portion of our net operating loss carryforwards prior to their expiration63% rewritten
31. 31The market price of our common stock has been, and is likely to remain, volatile, subject to low trading volume and may decline in value
32. 32We do not pay dividends and this may negatively affect the price of our stock
33. 33Restricted stock awards, performance-based restricted stock units and the exercise of stock options may depress our stock price and may result in dilution to our common stockholders34% rewritten
34. 34If we experience an ownership change, either via a major transaction or a series of trades where a substantial percentage of our ownership changes, which may be less than a majority of our ownership in certain cases, we may be limited in our ability to use our net operating loss carryforwards49% rewritten
35. 35A material weakness in our internal control over financial reporting could result in material misstatements in our financial statements and cause us to fail to meet our reporting and financial obligations
36. 36Any future pandemic, epidemic or outbreak of any highly infectious disease could cause disruptions in the U.S., regional and global economies and could materially and adversely impact our business, financial condition and results of operations and the business, financial condition and results of operations
37. 37We may become subject to legal and regulatory proceedings that could have a material adverse impact on our business, results of operations and financial condition
38. 38We do not collect sales or consumption taxes in some jurisdictions
39. 39If we are unsuccessful in our efforts to implement and support information technology improvements or respond to technological changes, our growth, prospects and results of operations could be adversely affected
40. 40Cybersecurity risks and cyber incidents could adversely affect our business and disrupt operations22% rewritten
41. 41Technological interruptions or the efficiency of our technology solutions could damage our reputation and brand and adversely affect our results of operations
42. 42Failure to maintain the privacy and security of our customer, third-party payer, employee, supplier, or Company information could result in substantial costs or subject us to litigation, enforcement actions, and reputational damage
43. 43Natural disasters, pandemics, acts of war or terrorism and other external events could significantly impact our business
44. 44We are dependent upon executive officers and other key personnel. The loss of any of our executive officers or other key personnel could reduce our ability to manage our businesses and achieve our business plan, which could cause our sales to decline and our operating results and cash flows to suffer