STERIS (STE) risk factors, FY2026 10-K

STERIS's FY2026 10-K, filed May 29, 2026, lists 35 risk factors in 4 groups. Against the prior year's 34: 6 new, 5 dropped, 17 substantially reworded.

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Risk factors listed
354 groups
New this year
6vs 34 last year
Dropped
5since the prior 10-K
Substantially reworded
17of those kept
Section length
11k wordsItem 1A

What the changes say

  • Tax exposure now emphasizes U.S. CAMT, EU GloBE rules, OBBBA guidance and changing non-U.S. tax rates.

What changed since the prior 10-K

New

  • NewTax Risks

    liability in the U.S. is lower than the income tax liability calculated under the CAMT provisions, we will be subject to additional income taxes in the U.S

    U.S. CAMT and international OECD Pillar Two rules could increase STERIS’s tax liability and alter long-standing tax positions.

  • NewBUSINESS AND OPERATIONAL RISKS

    These changes, and any other new or pending legal or regulatory matters, may result in the expenditure of additional resources or costs to comply with such requirements, which could affect our financial condition, results of operations or cash flows

    Changing permits and regulation, especially scrutiny of EO sterilization emissions, could close facilities or increase AST compliance costs.

  • NewBUSINESS AND OPERATIONAL RISKS

    working capital, acquisitions, capital expenditures and general corporate matters, including dividend payments and stock repurchases, limiting our flexibility in planning for, or reacting to, changes in our business and our industry and creating a disadvantage compared to our competitors with less indebtedness

    Debt-market constraints, credit downgrades and high interest rates could raise financing costs for STERIS and its Customers, suppliers and counterparties.

  • NewRISKS RELATED TO BUSINESS DEVELOPMENT

    Our investments in our business and product offerings may not be as successful as anticipated

    Investments in technology, infrastructure, new businesses, products and manufacturing may fail to deliver expected returns while diverting management attention.

  • NewRISKS RELATED TO BUSINESS DEVELOPMENT

    STERIS has incurred and expects to incur significant transaction and related costs in connection with strategic transactions, which may be in excess of those anticipated

    Acquisition, disposition and joint-venture integrations may generate substantial unexpected costs, including retention, advisory, severance, facility and system expenses.

  • NewRISKS RELATED TO BUSINESS DEVELOPMENT

    well as the realization of other efficiencies related to the integration of acquired businesses, should allow STERIS to offset integration-related costs over time, this net benefit may not be achieved in the near term, or at all

    Dispositions may leave STERIS with transition services, guarantees, indemnities or other obligations tied to businesses it no longer owns.

Dropped

  • DroppedTax Risks

    We might be adversely impacted by tax legislation or challenges to our tax positions

  • DroppedBUSINESS AND OPERATIONAL RISKS

    expectations and standards could result in advocacy group campaigns or legal and regulatory proceedings against us that could materially adversely affect our business, reputation, results of operations, financial condition and stock price

  • DroppedBUSINESS AND OPERATIONAL RISKS

    We could experience a failure of a key information technology system, process or site or a breach of information security, including a cybersecurity breach of one or more key information technology systems, networks, processes, associated sites or service providers

  • DroppedRISKS RELATED TO BUSINESS DEVELOPMENT

    STERIS has incurred substantial expenses in connection with the negotiation and completion of past business acquisitions and dispositions, and expects to incur similar costs for any future business acquisitions or dispositions

  • DroppedRISKS RELATED TO BUSINESS DEVELOPMENT

    We may fail to realize all of the anticipated benefits of our strategic business initiatives, as well as acquisitions, dispositions or joint ventures, or those benefits may take longer to realize than expected

Reworded

  • 90% rewrittenBUSINESS AND OPERATIONAL RISKS

    Our business and results of operations may be adversely affected if we are unable to recruit and retain qualified management and other personnel

    The personnel risk is materially shorter this year, removing the discussion of challenging labor markets, competition for talent and management distraction.

  • 87% rewrittenTax Risks

    Current economic and political conditions make tax rules in any jurisdiction subject to significant change

    The tax discussion replaces TCJA and interest-deduction details with the July 2025 OBBBA, limited guidance, non-U.S. rate increases and uncertain future impact.

  • 82% rewrittenBUSINESS AND OPERATIONAL RISKS

    We may be adversely affected by global climate change or by existing and future legal, regulatory or market responses to such change

    The climate risk removes differing jurisdictional stakeholder positions and focuses more broadly on evolving compliance and other requirements as transition risks.

  • 70% rewrittenBUSINESS AND OPERATIONAL RISKS

    Expectations relating to corporate responsibility considerations expose us to potential liabilities, increased costs, reputational harm and other adverse effects on our business

    The ESG risk now specifically names opposition to social commitments, sustainability goals, ESG policies and greenwashing allegations.

  • 65% rewrittenTax Risks

    We may be adversely impacted by changes in tax laws or challenges to our tax positions, and our effective tax rate is uncertain and may vary from expectations, which could have a material impact on our results of operations and earnings per share

    The tax risk adds potential challenges to reporting positions, defense costs, unsuccessful defenses and material changes to tax provisions.

    Was: Our effective tax rate is uncertain and may vary from expectations, which could have a material impact on our results of operations and earnings per share

  • 60% rewrittenBUSINESS AND OPERATIONAL RISKS

    Our debt level or access to credit markets may limit our financial and business flexibility

    Reported debt declined from $2,043.7 million to $1,931.7 million, with private-placement notes down and revolver borrowings up.

  • 57% rewrittenBUSINESS AND OPERATIONAL RISKS

    Our business environment is highly competitive, and if we fail to compete successfully, our revenues and results of operations may be negatively impacted

    The competition risk removes examples of new competing technologies and disposable devices, adding required investment in manufacturing, engineering, quality, marketing and distribution.

  • 56% rewrittenRISKS RELATED TO BUSINESS DEVELOPMENT

    We engage in acquisitions and affiliations, divestitures, and other business arrangements. Our growth may be adversely affected if we are unable to successfully identify and price strategic business candidates or otherwise optimize our business portfolio

    The transaction risk now includes joint ventures explicitly and no longer discusses financing requirements or whether past transactions proved strategically successful.

    Was: We engage in acquisitions and affiliations, divestitures, and other business arrangements. Our growth may be adversely affected if we are unable to successfully identify, price, and integrate strategic business candidates or otherwise optimize our business portfolio

  • 55% rewrittenBUSINESS AND OPERATIONAL RISKS

    If our continuing efforts to create a Lean business, to in-source production and to support smart manufacturing to reduce costs are not successful, our profitability may be negatively impacted or our business otherwise might be adversely affected

    Was: If our continuing efforts to create a Lean business and in-source production to reduce costs are not successful, our profitability may be negatively impacted or our business otherwise might be adversely affected

  • 54% rewrittenLEGAL, REGULATORY AND TAX RISKS

    Compliance with multiple, and potentially conflicting, international laws and regulations, import and export limitations, anti-corruption laws, and exchange controls may be difficult, burdensome or expensive

  • 53% rewrittenRISKS RELATED TO BUSINESS DEVELOPMENT

    Our acquisition activity and ability to grow organically may be adversely affected if we are unable to continue to access the financial markets

  • 48% rewrittenLEGAL, REGULATORY AND TAX RISKS

    The effects of geopolitical instability may adversely affect us and create significant risks and uncertainties for our business, with the ultimate impact dependent on future developments, which are highly uncertain and unpredictable

  • 41% rewrittenRISKS RELATED TO BUSINESS DEVELOPMENT

    The integration of acquired businesses into STERIS or working arrangements with joint venture partners may not be as successful as anticipated

    Was: The integration of acquired businesses into STERIS may not be as successful as anticipated

  • 37% rewrittenTax Risks

    Changes in tax treaties and trade agreements could negatively impact our costs, results of operations and earnings per share

  • 29% rewrittenBUSINESS AND OPERATIONAL RISKS

    A pandemic or similar public health crisis could have a material adverse impact on our ability to staff our operations

  • 21% rewrittenBUSINESS AND OPERATIONAL RISKS

    Our EO sterilization operations subject us to claims of liability and associated adverse effects

  • 21% rewrittenRISKS RELATED TO BUSINESS DEVELOPMENT

    Past and future business acquisitions may not be as accretive to STERIS’s earnings per share and cash flow from operations per share, which may negatively affect the market price of STERIS shares

All 35 risk factors

Headings as the filing states them, in filing order.

LEGAL, REGULATORY AND TAX RISKS

  1. 01Changes in economic climate may adversely affect us
  2. 02The effects of geopolitical instability may adversely affect us and create significant risks and uncertainties for our business, with the ultimate impact dependent on future developments, which are highly uncertain and unpredictable48% rewritten
  3. 03Compliance with multiple, and potentially conflicting, international laws and regulations, import and export limitations, anti-corruption laws, and exchange controls may be difficult, burdensome or expensive54% rewritten
  4. 04Changes in healthcare policy or government and other third-party payor reimbursement levels to healthcare providers, or failure to meet healthcare reimbursement or other requirements, might negatively impact our business
  5. 05We are subject to extensive regulatory requirements and must receive and maintain regulatory clearance or approval for many products and operations. Failure to receive or maintain, or delays in receiving, clearance or approvals may negatively impact our revenues, profitability, financial condition, or value
  6. 06Our products are subject to recalls and restrictions, even after receiving U.S. or foreign regulatory clearance or approval
  7. 07We may be adversely affected by product liability claims or other legal actions or regulatory or compliance matters
  8. 08Some product replacements or substitutions may not be possible or may be prohibitively costly or time consuming. The impact of any legal, regulatory, or compliance claims, proceeding, investigation, or litigation, is difficult to predict
  9. 09Our business and financial condition could be adversely affected by difficulties in acquiring or maintaining a proprietary intellectual ownership position

Tax Risks

  1. 10We may be adversely impacted by changes in tax laws or challenges to our tax positions, and our effective tax rate is uncertain and may vary from expectations, which could have a material impact on our results of operations and earnings per share65% rewritten
  2. 11Current economic and political conditions make tax rules in any jurisdiction subject to significant change87% rewritten
  3. 12liability in the U.S. is lower than the income tax liability calculated under the CAMT provisions, we will be subject to additional income taxes in the U.SNew
  4. 13Changes in tax treaties and trade agreements could negatively impact our costs, results of operations and earnings per share37% rewritten

BUSINESS AND OPERATIONAL RISKS

  1. 14Our business environment is highly competitive, and if we fail to compete successfully, our revenues and results of operations may be negatively impacted57% rewritten
  2. 15Consolidations among our healthcare and pharmaceutical Customers may result in a loss of Customers or more significant pricing pressures
  3. 16Supply chain disruption might increase our production costs, limit our production capabilities or curtail our operations
  4. 17Our operations, and those of our suppliers, are subject to a variety of business continuity hazards and risks, any of which could interrupt production or operations or otherwise adversely affect our performance, results, or value
  5. 18Expectations relating to corporate responsibility considerations expose us to potential liabilities, increased costs, reputational harm and other adverse effects on our business70% rewritten
  6. 19We may be adversely affected by global climate change or by existing and future legal, regulatory or market responses to such change82% rewritten
  7. 20These changes, and any other new or pending legal or regulatory matters, may result in the expenditure of additional resources or costs to comply with such requirements, which could affect our financial condition, results of operations or cash flowsNew
  8. 21Our EO sterilization operations subject us to claims of liability and associated adverse effects21% rewritten
  9. 22If our continuing efforts to create a Lean business, to in-source production and to support smart manufacturing to reduce costs are not successful, our profitability may be negatively impacted or our business otherwise might be adversely affected55% rewritten
  10. 23A pandemic or similar public health crisis could have a material adverse impact on our ability to staff our operations29% rewritten
  11. 24Our business and results of operations may be adversely affected if we are unable to recruit and retain qualified management and other personnel90% rewritten
  12. 25Our debt level or access to credit markets may limit our financial and business flexibility60% rewritten
  13. 26working capital, acquisitions, capital expenditures and general corporate matters, including dividend payments and stock repurchases, limiting our flexibility in planning for, or reacting to, changes in our business and our industry and creating a disadvantage compared to our competitors with less indebtednessNew

RISKS RELATED TO BUSINESS DEVELOPMENT

  1. 27We engage in acquisitions and affiliations, divestitures, and other business arrangements. Our growth may be adversely affected if we are unable to successfully identify and price strategic business candidates or otherwise optimize our business portfolio56% rewritten
  2. 28Our investments in our business and product offerings may not be as successful as anticipatedNew
  3. 29Our business realignment initiatives may not be as successful as anticipated
  4. 30Our acquisition activity and ability to grow organically may be adversely affected if we are unable to continue to access the financial markets53% rewritten
  5. 31The integration of acquired businesses into STERIS or working arrangements with joint venture partners may not be as successful as anticipated41% rewritten
  6. 32Past and future business acquisitions may not be as accretive to STERIS’s earnings per share and cash flow from operations per share, which may negatively affect the market price of STERIS shares21% rewritten
  7. 33STERIS has incurred and expects to incur significant transaction and related costs in connection with strategic transactions, which may be in excess of those anticipatedNew
  8. 34well as the realization of other efficiencies related to the integration of acquired businesses, should allow STERIS to offset integration-related costs over time, this net benefit may not be achieved in the near term, or at allNew
  9. 35We have recorded goodwill and other intangible assets that could become impaired and result in material non-cash charges to our results of operation in the future

Other STERIS 10-Ks

  • FY2025 10-K risk factors
    34 risks

    Steris faces extensive regulatory oversight by the FDA and foreign authorities across its medical device and sterilization operations. Acquisitions, integration costs, and $6 billion in goodwill and intangibles heavily shape the company's financial risk profile. Supply chain dependencies on key materials like cobalt-60 and EO create operational vulnerabilities.

    Filed May 29, 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.