Angiodynamics (ANGO) risk factors, FY2025 10-K

RISKS RELATED TO OUR BUSINESS AND INDUSTRY

1. 01We face intense competition in the medical device industry which continues to experience consolidation. We may be unable to compete effectively with respect to technological innovation and price which may have a material adverse effect on our revenues, financial condition, results of operations and/or liquidity
2. 02Our inability to continue to effectively develop, acquire and/or market new products and technologies could have a material adverse effect on our business, financial condition and/or results of operations
3. 03any of these products fail to achieve clinical acceptance or are perceived unfavorably by the market, it could severely limit our ability to drive revenue growth, which could have a material adverse effect on our business, financial condition, results of operations and/or liquidity
4. 04If we do not maintain our reputation with interventional physicians, interventional and surgical oncologists, and critical care nurses, our growth will be limited and our business could be harmed
5. 05determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts or if they participate in contemporaneous clinical trials of competing products
6. 06We are dependent on single and limited source suppliers which subjects our business and results of operations to risks of supplier business interruptions
7. 07We are heavily dependent on third-party distributors to generate a substantial portion of our international revenues and are at the risk of these distributors also selling for our competitors, failing to be financially viable and failing to effectively distribute our products in compliance with applicable laws
8. 08We face currency and other risks associated with international sales
9. 09If we are unable to convince customers that our products can improve the cost structure of their business, or to secure adequate reimbursement for our products our revenue growth and profitability may be materially and adversely impacted
10. 10If hospitals and physicians cannot obtain adequate reimbursement for our products or the procedures in which they are used, this could have a material adverse effect on our business, financial condition, results of operations and/or liquidity
11. 11Pending or future product liability claims brought against us, especially if our product liability insurance coverage is inadequate, could adversely impact our business, operations and financial results
12. 12We may be exposed to risks associated with product line divestitures as we may never realize the expected benefits and could cause operational disruptions with personnel, systems and infrastructure changes
13. 13International and national economic and industry conditions constantly change, and could materially and adversely affect our business, financial condition and results of operations
14. 14measures, selective price increases and taken other actions to offset these inflationary pressures in our supply chain, we may not be able to completely offset all the increases in our operational costs, any of which could adversely affect our business, financial condition, results of operations and/or liquidity
15. 15Our business could be harmed if we cannot hire or retain qualified personnel
16. 16If we are unable to manage our growth profitably, our business, financial results and stock price could suffer
17. 17We may fail to attract additional capital necessary to expand our business or may incur indebtedness which could impose operating and financial restrictions on us as a result of debt service obligations which could significantly limit our ability to execute our business strategy or curtail our growth
18. 18Inflationary pressure and unfavorable economic conditions could negatively affect our operations and business
19. 19A significant portion of our assets consist of intangible assets and fixed assets, the carrying value of which may be reduced if we determine that those assets are impaired, including intangible assets from recent acquisitions
20. 20We may be limited in our ability to utilize, or may not be able to utilize, net operating loss carryforwards to reduce our future tax liability
21. 21A cyber-attack or other breach of our, our distributors, or our supply chain partners' information technology systems could have a material adverse effect on our business, financial condition and/or results of operations
22. 22Artificial intelligence based platforms present new risks and challenges to our business
23. 23Any disaster at our manufacturing facilities or those of our suppliers could disrupt our ability to manufacture our products for a substantial amount of time
24. 24Anti-takeover provisions in our organizational documents and Delaware law may discourage or prevent a change of control, even if an acquisition would be beneficial to our stockholders, which could cause our stock price to decline and prevent attempts by our stockholders to replace or remove our current management
25. 25Global health crises, pandemics, epidemics or other outbreaks could adversely impact our business, operations and financial results
26. 26We could be negatively impacted by Environmental, Social and Governance (ESG), climate change and other sustainability-related matters

RISKS RELATED TO THE REGULATORY ENVIRONMENT

1. 27We are subject to a comprehensive system of federal, state and international laws and regulations, and we could be the subject of investigations, enforcement actions or face lawsuits and monetary or equitable judgments
2. 28If we or some of our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, and other applicable post-market requirements, our manufacturing operations could be disrupted, our product sales and profitability could suffer, and we may be subject to a wide variety of FDA enforcement actions
3. 29If we cannot obtain and maintain marketing clearance or approval from governmental agencies, we will not be able to sell our products
4. 30Our products may be subject to product recalls, which may harm our reputation and divert managerial and financial resources
5. 31We may be subject to fines, penalties, injunctions or costly investigations if we are determined to be promoting the use of our products for unapproved or “off-label” uses

RISKS RELATED TO INTELLECTUAL PROPERTY

1. 32If we fail to adequately protect our intellectual property rights, we may not be able to generate revenues from new or existing products and our business may suffer
2. 33patents, that any current or future patents issued to, or licensed by us, will not be challenged or circumvented by our competitors, or that our patents will not be found invalid
3. 34If third parties claim that our products infringe their intellectual property rights, we may be forced to expend significant financial resources and management time defending against such actions and our financial condition and our results of operations could suffer

RISKS RELATED TO OUR STOCK PRICE

1. 35Our future operating results are difficult to predict and may vary significantly from quarter to quarter, which may adversely affect the price of our common stock
2. 36Our stock price may be volatile, which may cause the value of our stock to decline or subject us to a securities class action litigation