Staar Surgical (STAA) risk factors, FY2024 10-K

Risks Related to Our Business

1. 01We reported a decrease in revenue and a net loss in fiscal 2024, and we may not be able to return to our growth and profitability trajectory
2. 02Our reliance on independent distributors in international markets exposes us to commercial and other risks
3. 03A slowdown or disruption to the Chinese economy or worsening trade relations between the U.S. and China could materially impact our business and results of operations
4. 04Unfavorable economic conditions or negative publicity concerning complications of laser eye surgery, or medical devices in general, could hurt sales of our refractive products
5. 05Disruptions in our supply chain or failure to adequately forecast product demand could result in significant delays or lost sales
6. 06regulatory approvals to use alternative suppliers may be a lengthy and uncertain process during which production could be delayed and we could lose sales
7. 07Because our business is global, our sales and profits may fluctuate or decline in response to changes in foreign currency exchange rates and/or other international risks, including tariffs
8. 08Changes in our effective tax rate or additional tax liabilities could adversely impact our net income
9. 09Changes in tax laws could result in additional tax liabilities
10. 10We are vulnerable to any loss of use of our principal manufacturing facility
11. 11Public health crises, political crises, and other catastrophic events or other events outside of our control may impact our business
12. 12The loss of key employees, or our inability to recruit, hire and retain skilled and experienced personnel, could negatively impact our ability to effectively manage and expand our business
13. 13We compete with much larger companies and low-cost Asian manufacturers
14. 14We could experience losses due to product liability claims
15. 15Our defined benefit pension plans are currently underfunded and we may be subject to significant increases in pension benefit obligations under those pension plans
16. 16Our activities involve hazardous materials, emissions, and use of an irradiator and may subject us to environmental liability
17. 17Data corruption, cyber-based attacks or network security breaches and/or noncompliance with data protection and privacy regulations could negatively impact our operations
18. 18The increased use of social media platforms and mobile technologies presents additional risks and challenges
19. 19Acquisitions of technologies, products, and businesses could disrupt our operations, involve increased expenses and present risks not contemplated at the time of the transactions
20. 20If we are not able to manage growth successfully, it could adversely affect our business, financial condition, and results of operations
21. 21Corporate responsibility, specifically related to environmental, social and governance (ESG) matters, may impose additional costs, expose us to reputational and emerging areas of risks, and could negatively affect our business
22. 22Climate changes and extreme weather conditions could negatively affect our business

Risks Related to the Ophthalmic Products Industry

1. 23Unless we keep pace with advances in our industry and persuade physicians to adopt our new products, our sales will not grow and may decline
2. 24Resources devoted to research and development may not yield new ophthalmic products that achieve regulatory approval or commercial success
3. 25We may be required to conduct extensive clinical trials to demonstrate safety and effectiveness of new or enhanced ophthalmic products, such clinical trials are expensive, complex, can take years to complete, and have highly uncertain outcomes
4. 26Complying with government regulation substantially increases the cost of developing, manufacturing and selling our ophthalmic products
5. 27We depend on proprietary technology, but our intellectual property protections may be limited
6. 28We may not successfully replace our existing products, including those that lose or have lost patent protection
7. 29While we will continue developing intellectual property protections for our future products, third parties may pursue blocking patents that limit our ability to manufacture such products

Risks Related to Regulatory and Compliance

1. 30We are subject to extensive government regulation worldwide, which increases our costs and could prevent us from selling our products
2. 31Regulatory issues may adversely impact our operations
3. 32Laws pertaining to healthcare fraud and abuse could materially adversely affect our business, financial condition, and results of operations
4. 33If we recall a product, the cost and damage to our reputation could harm our business
5. 34inconvenience caused by recalls and related interruptions in supply, the underlying causal issues, and the damage to our reputation, could cause professionals to discontinue using our products
6. 35Changes in U.S. FDA or international regulations related to product approval, including those that apply retroactively, could make us less competitive and harm our business
7. 36If our products cause or contribute to a death or a serious injury, we may face voluntary corrective actions, agency enforcement actions and harm to our results
8. 37If we modify our products, we may have to obtain new marketing clearances or approvals or may have to cease marketing or recall the modified products until clearances or approvals are obtained
9. 38to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties
10. 39Non-compliance with anti-corruption laws could lead to penalties or harm our reputation
11. 40Investigations and allegations, whether or not they lead to enforcement action or litigation, can materially harm our business and our reputation

Risks Related to Ownership of Our Common Stock

1. 41The market price of our common stock has been and will likely continue to be volatile
2. 42Because we do not intend to pay dividends, stockholders will benefit from an investment in our common stock only if it appreciates in value
3. 43upon any future appreciation. There is no guarantee that our common stock will appreciate in value or even maintain the price at which stockholders purchase their shares
4. 44stockholders must give advance notice to nominate directors or propose other business
5. 45Ownership of our common stock is concentrated among a few investors, which may affect the ability of a third party to acquire control of us. Substantial sales by such investors could cause our common stock price to decline
6. 46Future sales of our common stock could reduce our stock price