Sotera Health (SHC) risk factors, FY2025 10-K

Sotera Health's FY2025 10-K, filed Feb 24, 2026, lists 45 risk factors in 3 groups. Against the prior year's 45: 5 new, 5 dropped, 10 substantially reworded.

Risk factors listed
453 groups
New this year
5vs 45 last year
Dropped
5since the prior 10-K
Substantially reworded
10of those kept
Section length
23k wordsItem 1A

What the changes say

  • Sotera Health Co highlights growing debt loads, new AI integration liabilities, and regulatory risks regarding cannabis and trade sanctions.

What changed since the prior 10-K

New

  • NewRisks Related to the Company

    Safety risks associated with the use, storage, transportation and disposal of potentially hazardous materials, such as EO and Co-60, may result in accidents or liabilities that materially affect our results of operations

    Safety risks involving the storage, transportation, and use of hazardous materials like flammable ethylene oxide and radioactive cobalt-60 could cause accidents and liabilities.

  • NewRisks Related to the Company

    these permits and licenses could delay or prevent us from fulfilling our obligations to our customers or suppliers, which could harm our business, financial condition or results of operations

    International operations expose the company to complex and changing U.S. economic sanctions and Office of Foreign Assets Control regulations.

  • NewRisks Related to the Company

    We may be incorporating AI technologies into our products, services and processes, which may present business, compliance and reputational risks

    Incorporating AI and machine-learning technologies into products and internal processes creates new compliance, litigation, intellectual property, and data privacy risks.

  • NewRisks Related to Our Indebtedness and Liquidity

    As of December 31, 2025, our total indebtedness was approximately $2,169.5 million, all of which is indebtedness of our subsidiary Sotera Health Holdings, LLC (“SHH”) that is guaranteed by the Company and certain of our other subsidiaries

    As of December 31, 2025, total indebtedness reached approximately $2,169.5 million through subsidiary Sotera Health Holdings, LLC.

  • NewRisks Related to Our Indebtedness and Liquidity

    defined below) that governs the Secured Notes (as defined below) (together the “Combined Senior Secured Credit Facilities”). If new indebtedness is added to our current debt levels, the related risks that we now face could intensify

    Variable interest rates on senior secured credit facilities expose the company to increased debt service obligations if interest rates rise.

Dropped

  • DroppedRisks Related to the Company

    including prohibiting imports of certain goods from certain other countries and exports of certain goods from Russia to certain other countries

    Expanded Russian sanctions targeting nuclear reactor operators, banks, and logistics providers.

  • DroppedRisks Related to the Company

    EO is flammable and potentially explosive. Despite our extensive safety measures, a fire or explosion could occur at a sterilization facility where we use EO, which could interrupt our normal operations and result in facility closures, workplace injuries, property damage, or otherwise adversely affect our business

  • DroppedRisks Related to Our Indebtedness and Liquidity

    December 31, 2024, our cash flow used for debt service totaled $184.9 million, which was comprised of $5.0 million of principal payments on the Term Loan (as defined herein) and interest payments of $179.9 million on all of our outstanding debt

    Flammability of EO and radioactive containment risks of Co-60 pencils.

  • DroppedRisks Related to Our Indebtedness and Liquidity

    meet those financial ratios and tests can be affected by events beyond our control, including prevailing economic, financial market and industry conditions, and we cannot give assurance that we will be able to satisfy such ratios and tests when required

  • DroppedRisks Related to Our Indebtedness and Liquidity

    Term SOFR and certain other interest “benchmarks” are subject to regulatory guidance and reform that we expect will cause interest rates under our current or future debt agreements to perform differently than in the past or could cause other unanticipated consequences

Reworded

  • 52% rewrittenRisks Related to Our Indebtedness and Liquidity

    The agreements governing our debt, including the Secured Notes, contain various covenants that impose restrictions on us and limit our flexibility in operating our business

    Updated debt covenant descriptions governing the Secured Notes and Senior Secured Credit Facilities.

  • 50% rewrittenRisks Related to the Company

    We may be adversely affected by global and regional economic and political instability

    General geopolitical conflicts replaced specific references to the Israel-Hamas war impacting global supply chains.

  • 50% rewrittenRisks Related to the Company

    We are subject to significant regulatory oversight of our import and export operations due to the nature of some of our product offerings

    Clarified regulatory oversight and licensing requirements for import and export operations involving Co-60 and other materials.

  • 49% rewrittenRisks Related to the Company

    We have a history of net losses and may not maintain profitability in future periods

    Added net income figures of $77.9 million for 2025 alongside 2044 figures and noted potential future losses from debt expenses.

    Was: We have a history of net losses and may not maintain profitability in the future

  • 49% rewrittenRisks Related to the Company

    Our business is subject to a variety of laws involving the cannabis industry, many of which are unsettled and still developing and which could subject us to claims or otherwise harm our business

    Added reference to the December 18, 2025 Executive Order directing the reclassification of marijuana to a Schedule III controlled substance.

  • 36% rewrittenRisks Related to Ownership of Our Common Stock

    The interests of our Sponsors may differ from the interests of other stockholders of the Company

    Updated Sponsor common stock ownership down from 43.4% to 20.0% and director designation count to three.

  • 33% rewrittenRisks Related to the Company

    Unionization efforts and labor regulations could materially increase our costs or limit our flexibility

    Minor phrasing adjustments regarding unionization efforts, works councils, and collective bargaining agreements in Brazil and Mexico.

  • 22% rewrittenRisks Related to the Company

    Potential health risks associated with the use of EO may subject us to future liability claims and associated adverse effects

    Added specific references to the U.S. EPA 2016 Integrated Risk Information System toxicity assessment of ethylene oxide.

  • 22% rewrittenRisks Related to Ownership of Our Common Stock

    A sale of a substantial number of shares of our common stock, or the perception that such sales might occur, may cause the price of our common stock to decline

  • 21% rewrittenRisks Related to Ownership of Our Common Stock

    The future issuance of additional common stock in connection with our incentive plans, acquisitions or otherwise will dilute all other stockholdings

All 45 risk factors

Headings as the filing states them, in filing order.

Risks Related to the Company

  1. 01We may be subject to evolving changes in environmental, health and safety regulations, which may negatively impact our business
  2. 02Safety risks associated with the use, storage, transportation and disposal of potentially hazardous materials, such as EO and Co-60, may result in accidents or liabilities that materially affect our results of operationsNew
  3. 03Potential health risks associated with the use of EO may subject us to future liability claims and associated adverse effects22% rewritten
  4. 04We are currently defending certain litigation, and we are likely to be subject to additional litigation in the future
  5. 05Allegations of our failure to properly perform our services may expose us to potential product liability claims, recalls, penalties and reputational harm or could otherwise cause a material adverse effect on our business
  6. 06Safety risks associated with the transportation of potentially hazardous materials, such as EO and Co-60, may result in accidents or liabilities that materially affect our results of operations
  7. 07Industry trends could impact the demand for our products and services and could have a material adverse effect on our business
  8. 08Our business is highly competitive, and if we fail to compete successfully, our business, prospects, financial condition or results of operations may be materially adversely affected
  9. 09The price of our input costs, including labor, raw materials and energy, are subject to inflation and other market risks and our ability to pass through increases in our input costs is highly dependent on market conditions
  10. 10We may be adversely affected by global and regional economic and political instability50% rewritten
  11. 11If we are unable to increase capacity at existing facilities and build new facilities in a timely and cost-effective manner, we may not achieve our expected revenue growth or profitability or such revenue growth and profitability, if any, could be delayed
  12. 12We depend upon our ability to attract and retain highly skilled employees. If we fail to attract and retain the talent required for our business, our operations could be adversely affected and our business could be materially harmed
  13. 13We occupy many of our facilities under long-term leases, and we may be unable to renew our leases at the end of their terms
  14. 14We conduct sales and distribution operations on a worldwide basis and are subject to a variety of risks associated with doing business outside the United States
  15. 15We are subject to significant regulatory oversight of our import and export operations due to the nature of some of our product offerings50% rewritten
  16. 16these permits and licenses could delay or prevent us from fulfilling our obligations to our customers or suppliers, which could harm our business, financial condition or results of operationsNew
  17. 17Severe health events or environmental events, including impacts from climate change, and natural disasters, could have material adverse effects on our business, financial condition and results of operations
  18. 18Our business may be subject to system interruptions, cybersecurity incidents and unauthorized data disclosures
  19. 19We may be incorporating AI technologies into our products, services and processes, which may present business, compliance and reputational risksNew
  20. 20Part of our growth strategy is to pursue strategic transactions, including acquisitions, which subjects us to risks that could harm our business and we may not be able to find suitable acquisition targets or integrate strategic acquisitions successfully into our existing business
  21. 21Our internal control over financial reporting may not be effective and our independent registered public accounting firm may not be able to certify as to their effectiveness, which could have a significant and adverse effect on our business and reputation
  22. 22We rely on intellectual property rights to maintain our competitive position and third parties have claimed in the past, and may claim in the future, that we infringe or misappropriate their intellectual property rights
  23. 23We are subject to complex and rapidly evolving data privacy and security laws and regulations, and any ineffective compliance efforts with such laws and regulations may adversely impact our business
  24. 24We have a history of net losses and may not maintain profitability in future periods49% rewritten
  25. 25We may incur impairment charges on our goodwill and other intangible assets with indefinite lives as well as other long-lived assets and intangible assets with definite lives, which could adversely affect our business, financial condition or results of operations
  26. 26Unionization efforts and labor regulations could materially increase our costs or limit our flexibility33% rewritten
  27. 27Our business is subject to a variety of laws involving the cannabis industry, many of which are unsettled and still developing and which could subject us to claims or otherwise harm our business49% rewritten
  28. 28Government or private civil antitrust actions could harm our business, prospects, financial condition or results of operations
  29. 29We may have greater than anticipated tax liabilities, which could harm our business, revenue and financial results

Risks Related to Our Indebtedness and Liquidity

  1. 30As of December 31, 2025, our total indebtedness was approximately $2,169.5 million, all of which is indebtedness of our subsidiary Sotera Health Holdings, LLC (“SHH”) that is guaranteed by the Company and certain of our other subsidiariesNew
  2. 31defined below) that governs the Secured Notes (as defined below) (together the “Combined Senior Secured Credit Facilities”). If new indebtedness is added to our current debt levels, the related risks that we now face could intensifyNew
  3. 32The agreements governing our debt, including the Secured Notes, contain various covenants that impose restrictions on us and limit our flexibility in operating our business52% rewritten
  4. 33Our cash flows may not be sufficient to service our indebtedness, and if we are unable to satisfy our obligations under our indebtedness, we may be required to seek other financing alternatives, which may not be successful
  5. 34A lowering or withdrawal of the ratings assigned to our debt by rating agencies may increase our future borrowing costs and reduce our access to capital
  6. 35SHH is a holding company, and therefore its ability to make any required payment on our credit agreements depends upon the ability of its subsidiaries to pay it dividends or to advance it funds

Risks Related to Ownership of Our Common Stock

  1. 36The market and trading volume of our common stock may be volatile, and you could lose all or part of your investment
  2. 37The future issuance of additional common stock in connection with our incentive plans, acquisitions or otherwise will dilute all other stockholdings21% rewritten
  3. 38Future offerings of debt or equity securities by us may adversely affect the market price of our common stock
  4. 39A sale of a substantial number of shares of our common stock, or the perception that such sales might occur, may cause the price of our common stock to decline22% rewritten
  5. 40Any sales of securities by any of our stockholders described above could have a material adverse effect on the market price of our common stock
  6. 41The interests of our Sponsors may differ from the interests of other stockholders of the Company36% rewritten
  7. 42Certain of our stockholders have the right to engage or invest in the same or similar businesses as us
  8. 43Anti-takeover provisions in our Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws and the Stockholders Agreement, as well as Delaware law, could discourage a change in control of our company or a change in our management
  9. 44Our Amended and Restated Certificate of Incorporation designates specific courts as the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ abilities to obtain a favorable judicial forum for disputes with us or our directors, officers or employees
  10. 45We do not anticipate paying any dividends on our common stock in the foreseeable future, and, consequently, our stockholders’ ability to achieve a return on their investment depends on appreciation in the price of our common stock

Other Sotera Health 10-Ks

  • FY2024 10-K risk factors
    45 risks

    High debt leverage requires significant cash flow for debt service and interest payments. Sterilization operations carry severe risks of ethylene oxide fires, explosions, and radioactive Cobalt-60 contamination. Legal liabilities from ethylene oxide health risks and ongoing litigation threaten business operations. Regulatory oversight, environmental compliance, and input cost inflation create margin pressures.

    Filed Feb 27, 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.