Haemonetics (HAE) risk factors, FY2025 10-K

Risks Related to our Business and Industry

1. 01If our business strategy does not yield the expected results or we fail to implement the necessary changes to our operations, we could see material adverse effects on our business, financial condition or results of operations
2. 02Material reductions in purchasing from or loss of a significant customer could adversely affect our business
3. 03We face intense competition, and if we are unable to successfully expand our product lines through internal research and new product development or keep pace with rapid technological changes in the healthcare industry, our business may be materially and adversely affected
4. 04Defects or quality issues associated with our products could adversely affect the results of operations
5. 05If our business development activities are unsuccessful, we may not realize the intended benefits
6. 06We are increasingly dependent on information technology systems and subject to privacy and security laws and a cyber-attack or other breach of these systems could have a material adverse effect on our business, financial condition or results of operations
7. 07We outsource certain aspects of our business to a single third-party vendor that subjects us to risks, including disruptions in business and increased costs
8. 08An interruption in our ability to manufacture our products, obtain key components or raw materials, or the failure of a sole source supplier or sterilization service provider may adversely affect our business
9. 09Changes in the cost, composition or availability of the plastics we purchase, or of other raw materials and components used in our products, could adversely affect our business, financial condition and results of operations
10. 10We may not realize the benefits we expect from cost reduction initiatives

Risks Related to Government Regulation

1. 11As a medical device and drug manufacturer, we operate in a highly regulated industry, and non-compliance with applicable laws or regulations could adversely affect our financial condition and results of operations
2. 12If we or our suppliers fail to comply with laws and regulations governing the manufacture and production of our products, our products could be subject to restrictions or withdrawal from the market
3. 13Any future failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA or other regulatory authority could result in administrative actions, field actions, or civil or criminal enforcement actions
4. 14As a medical device and drug manufacturer, we are subject to safety reporting requirements
5. 15Changes in tax laws or exposure to additional income tax liabilities could have a material impact on our financial condition, results of operations and/or liquidity

Risks Related to our Financial Obligations and Indebtedness

1. 16We have a significant amount of debt that may decrease our business flexibility, access to capital, and/or increase our borrowing costs, and we may still incur additional debt in the future, which may adversely affect our operations and financial results
2. 17The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and operating results
3. 18The Capped Call Transactions may affect the value of the Notes and our common stock
4. 19We are subject to counterparty risk with respect to the Capped Call Transactions
5. 20Provisions in the Indentures could delay or prevent an otherwise beneficial takeover of us
6. 21Conversion of the Notes may dilute the ownership interest of existing stockholders

Risks Related to Operating Internationally

1. 22As a substantial amount of our revenue comes from outside the U.S., we are subject to geopolitical events, economic volatility, violations of anti-corruption laws, export and import restrictions and tariffs, decisions by local regulatory authorities and the laws and medical practices in foreign jurisdictions
2. 23We sell our products in certain emerging economies which exposes us to less mature regulatory systems, more volatile markets for our products and greater credit risks. A loss of funding for our products or changes to the regulatory regime could lead to lost revenue or account receivables
3. 24In many of the international markets in which we do business, including certain parts of Europe, South America, the Middle East and Asia, our employees, agents or distributors offer to sell our products in response to public tenders issued by various governmental agencies
4. 25We are exposed to fluctuations in currency exchange rates, which could adversely affect our cash flows and results of operations
5. 26Our effective tax rate may fluctuate and we may incur obligations in tax jurisdictions in excess of amounts that have been accrued

Risks Related to Intellectual Property and Litigation

1. 27There is a risk that our intellectual property may be subject to misappropriation in some countries
2. 28Pending and future intellectual property litigation could be costly and disruptive to us
3. 29Our products may be determined to infringe another party’s patent, which could lead to financial losses or adversely affect our ability to market our products
4. 30Some of our products are also subject to performance guarantee programs, which may require us to compensate customers when clinical outcomes do not meet specified thresholds. Adverse events associated with these products could increase the frequency or cost of such payments
5. 31Our success depends on our ability to attract and retain key personnel needed to successfully operate the business and to plan for future executive transitions
6. 32Our share price has been volatile and may fluctuate, and accordingly, the value of an investment in our common stock may also fluctuate
7. 33Share repurchase programs, including under our existing share repurchase authorization, could affect the price of our common stock and increase volatility and may be suspended or terminated at any time, which may result in a decrease in the trading price of our common stock
8. 34Our business could be negatively impacted by corporate responsibility matters
9. 35Climate change, or legal, regulatory or market measures to address climate change, could adversely affect our business, results of operations and financial condition
10. 36Actual or threatened public health crises could harm our business