Resmed (RMD) risk factors, FY2025 10-K

Risks Related to Our Business and Industry

1. 01Our inability to compete with new and existing technology to treat OSA successfully may harm our business
2. 02Consolidation in the healthcare industry and healthcare payment reform could have an adverse effect on our revenues and results of operations
3. 03Global macroeconomic conditions, including the direct and indirect effects of inflation, supply chain disruptions, reciprocal tariffs, and fluctuations in foreign currency exchange rates, could adversely affect our operations and profitability
4. 04Our business, financial condition and results of operations could be harmed by the effects of pandemics, epidemics, or other public health crises
5. 05We are subject to various risks relating to international activities that could affect our overall profitability
6. 06Our products are the subject of clinical trials conducted by us, our competitors, or other third parties, the results of which may be unfavorable, or perceived as unfavorable, and could have a material adverse effect on our business, financial condition, and results of operations
7. 07We are subject to potential product liability claims that may exceed the scope and amount of our insurance coverage, which would expose us to liability for uninsured claims
8. 08Our intellectual property may not protect our products, and/or our products may infringe on the intellectual property rights of third parties
9. 09If we fail to source, develop and retain key employees, our business may suffer
10. 10Our leverage and debt service obligations could adversely affect our business
11. 11We are subject to new areas of direct healthcare oversight by federal government agencies due to our acquisition of VirtuOx

Risks Related to Manufacturing, IT Systems, Commercial Operations and Plans for Future Growth

1. 12Disruptions in the supply of components from our suppliers could result in a significant reduction in sales and profitability
2. 13We are increasingly dependent on information technology systems and infrastructure
3. 14Actual or attempted breaches of security, unauthorized disclosure of information, attacks which reduce availability of systems such as denial of service, or the perception that personal and/or other sensitive or confidential information in our possession is not secure, could result in a material loss of business, substantial legal liability or significant harm to our reputation
4. 15We may not be able to realize the anticipated benefits from acquisitions, which could adversely affect our operating results
5. 16If we are unable to support our continued growth or achieve expected operating efficiencies, our business could suffer
6. 17Our business depends on our ability to market effectively to dealers of home healthcare products, sleep clinics, and physicians
7. 18The success of our software offerings depends substantially on customers entering, renewing, upgrading and expanding their agreements for cloud services, term licenses, and maintenance and support agreements with us
8. 19If our software products fail to perform properly or if we fail to develop enhancements, we could lose customers, become subject to service performance or warranty claims and our sales could decline
9. 20If there are interruptions or performance problems associated with our technology or infrastructure, our existing software customers may experience service outages, and our new customers may experience delays in the deployment of our platforms
10. 21Climate change and natural disasters, or other events beyond our control, could negatively impact our business operations and financial condition

Risks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts

1. 22Healthcare reform or other cost-cutting measures, including changes in coverage policy for our products and services, by government or commercial payors may have a material adverse effect on our industry and our results of operations
2. 23Government and private insurance plans may not adequately reimburse our customers for our products, which could result in reductions in sales or selling prices for our products
3. 24Our use and disclosure of personal information, including health information, is subject to federal, state and foreign privacy, artificial intelligence, data, biometrics and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in significant liability, regulatory investigations, legal actions, or reputational harm
4. 25The UK GDPR mirrors the fines under the EU GDPR, i.e., fines up to the greater of £17.5 million or 4% of global turnover
5. 26Our business activities are subject to extensive regulation, and any failure to comply could have a material adverse effect on our business, financial condition, or results of operations
6. 27Product sales, introductions or modifications may be delayed or canceled as a result of FDA regulations or similar foreign regulations, which could cause our sales and profits to decline
7. 28We are subject to substantial regulation related to quality standards applicable to our manufacturing and quality processes
8. 29Disruptions at the FDA and other government agencies caused by funding shortages, personnel reductions, or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business
9. 30Off-label marketing of our products could result in substantial penalties
10. 31Laws regulating consumer contacts could adversely affect our business operations or create liabilities
11. 32Tax laws, regulations, and enforcement practices are evolving, are aggressively pursued in some jurisdictions, and may cause expense as well as management distraction, which may result in a material adverse effect on our results of operations, cash flows and financial position
12. 33Sustainability and corporate governance issues are constantly evolving, leading to additional investment and expense, and may have an adverse effect on our business, financial condition and results of operations and reputation

Risks Related to the Securities Markets and Ownership of Our Common Stock

1. 34Our quarterly operating results are subject to fluctuation for a variety of reasons
2. 35Our ability to sustain or grow dividends or repurchase shares is subject to board discretion
3. 36Delaware law and provisions in our charter could make it difficult for another company to acquire us