STERIS (STE) risk factors, FY2025 10-K

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 unpredictable
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 expensive
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 might be adversely impacted by tax legislation or challenges to our tax positions
2. 11Current economic and political conditions make tax rules in any jurisdiction subject to significant change
3. 12Our 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
4. 13Changes in tax treaties and trade agreements could negatively impact our costs, results of operations and earnings per share

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 impacted
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 business
6. 19expectations 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
7. 20We may be adversely affected by global climate change or by existing and future legal, regulatory or market responses to such change
8. 21Our EO sterilization operations subject us to claims of liability and associated adverse effects
9. 22If 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
10. 23A pandemic or similar public health crisis could have a material adverse impact on our ability to staff our operations
11. 24Our business and results of operations may be adversely affected if we are unable to recruit and retain qualified management and other personnel
12. 25We 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
13. 26Our debt level or access to credit markets may limit our financial and business flexibility

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, price, and integrate strategic business candidates or otherwise optimize our business portfolio
2. 28Our business realignment initiatives may not be as successful as anticipated
3. 29Our acquisition activity and ability to grow organically may be adversely affected if we are unable to continue to access the financial markets
4. 30The integration of acquired businesses into STERIS may not be as successful as anticipated
5. 31Past 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
6. 32STERIS 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
7. 33We 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
8. 34We 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