InfuSystem Holdings (INFU) risk factors, FY2024 10-K

InfuSystem Holdings's FY2024 10-K, filed Mar 11, 2025, lists 43 risk factors. There is no earlier 10-K to compare against, so the most company-specific risks are listed below.

Risk factors listed
430 groups
Section length
9k wordsItem 1A

InfuSystem Holdings's biggest risks in the FY2024 10-K

  • InfuSystem's risks are dominated by healthcare reimbursement dependencies, regulatory compliance like Medicare supplier standards, and third-party supply chain vulnerabilities.

The risks most specific to InfuSystem Holdings

  • Any change in the overall healthcare reimbursement system may adversely impact our business

    Our revenues depend heavily on third-party reimbursement from private insurers and governmental agencies for our continuous infusion equipment and disposable supplies.

  • Payer concentration may adversely impact our business

    We depend on contracts with nearly 835 third-party payer networks, which dictate pre-negotiated or proprietary fee schedule rates for our equipment and supplies.

  • Our success is impacted by the availability of the chemotherapy drugs that are used in our continuous infusion pump systems

    A shortage in the availability of chemotherapy drugs used in our continuous infusion pump systems could materially harm our rental business and financial condition.

  • We are dependent on our Medicare Supplier Number

    We must maintain our Medicare Supplier Number and comply with Medicare DMEPOS Supplier Standards to bill Medicare and satisfy other payer and Medicaid contracts.

  • We 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

    We rely on a single major supplier, ICU Medical, Inc., to provide the majority of our new electronic infusion pumps.

  • The 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 expiration

    We hold $14.4 million in U.S. federal net operating loss carryforwards, of which $7.8 million will begin expiring in 2037.

All 43 risk factors

Headings as the filing states them, in filing order.

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 reimbursement
  3. 03revenue that may be derived from each patient treatment. If average reimbursement rates diverge from historical levels, the estimates of such revenue may diverge from actual collections
  4. 04The loss of a relationship with one or more third-party payers could negatively impact our business
  5. 05Any federal government shutdown may adversely impact our business
  6. 06Payer concentration may adversely impact our business
  7. 07Increased focus on early detection and diagnostics may adversely affect our business
  8. 08If 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
  9. 09Our success is impacted by the availability of the chemotherapy drugs that are used in our continuous infusion pump systems
  10. 10We are dependent on our Medicare Supplier Number
  11. 11The impact of realized and potential U.S. healthcare reform legislation on us remains uncertain
  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 significant 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 affected
  25. 25Failure to protect our intellectual property could substantially harm our business and operating results
  26. 26Covenants in our current and any future debt agreements restrict our business
  27. 27Economic uncertainty or deterioration or geopolitical instability could adversely affect us
  28. 28Changes in tax laws or challenges to our tax positions could adversely affect our business, results of operations and financial condition
  29. 29The 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 expiration
  30. 30The market price of our common stock has been, and is likely to remain, volatile, subject to low trading volume and may decline in value
  31. 31We do not pay dividends and this may negatively affect the price of our stock
  32. 32Restricted 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 stockholders
  33. 33If 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 carryforwards
  34. 34A 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
  35. 35Any 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
  36. 36We may become subject to legal and regulatory proceedings that could have a material adverse impact on our business, results of operations and financial condition
  37. 37We do not collect sales or consumption taxes in some jurisdictions
  38. 38If 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
  39. 39Cybersecurity risks and cyber incidents could adversely affect our business and disrupt operations
  40. 40Technological interruptions or the efficiency of our technology solutions could damage our reputation and brand and adversely affect our results of operations
  41. 41Failure 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
  42. 42Natural disasters, pandemics, acts of war or terrorism and other external events could significantly impact our business
  43. 43We 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

Other InfuSystem Holdings 10-Ks

  • FY2025 10-K risk factors
    44 risks2 new1 dropped12 reworded

    InfuSystem added new risks regarding healthcare advisory panel changes and state-level health privacy compliance complexity. Net operating loss carryforwards decreased from $14.4 million to $5.8 million, all of which now have indefinite lives. Third-party payer contract non-renewal risks were expanded.

    Filed Feb 27, 2026

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.