What the changes say
- Acquisitions of VirtuOx and Noctrix add malpractice, healthcare-oversight, integration and execution risks.
- AI use is now a standalone risk, while manufacturing faces FDA’s new QMSR requirements.
- Tax risk is more prominent, separating evolving laws from aggressive audits of transferred or discontinued operations.
- Dealer, clinic, physician and patient education is emphasized as important to product adoption and sales.
What changed since the prior 10-K
New
- NewRisks Related to Our Business and Industry
We are subject to potential professional services liability claims due to our recent acquisition of VirtuOx, which may exceed the scope and amount of our insurance coverage, which would expose us to liability for uninsured claims
VirtuOx’s diagnostic testing activities could generate malpractice claims exceeding insurance limits or falling under policy exclusions.
- NewRisks Related to Manufacturing, IT Systems, Commercial Operations and Plans for Future Growth
Failure to identify, execute, and integrate acquired businesses into our operations successfully, or challenges related to the Company's strategic initiatives, including divestitures
Multiple acquisitions, investments and divestitures, including MatrixCare’s separation, could overwhelm integration resources and increase execution complexity.
- NewRisks Related to Manufacturing, IT Systems, Commercial Operations and Plans for Future Growth
Our business depends on our ability to effectively educate and engage dealers of home healthcare products, sleep clinics and physicians, health care providers, and patients regarding the benefits of our products, software solutions and services
Limited ability to educate and engage dealers, clinics, physicians, providers and patients could reduce proper prescription, marketing and sales of ResMed offerings.
- NewRisks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts
Our use of artificial intelligence in certain products, software solutions and business operations may expose us to operational, regulatory and reputational risks that could adversely affect our business, financial condition and results of operations
AI features may produce unreliable outputs, face changing regulation, or lack suitable data, infrastructure and specialized personnel.
- NewRisks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts
Income tax laws, regulations, and enforcement practices in various jurisdictions are evolving and, as a result, tax authorities are aggressively pursuing taxpayers
Changing tax laws and increasingly aggressive multinational-company enforcement could increase taxes, compliance costs, disputes and management distraction.
- NewRisks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts
We are subject to ongoing tax audits by various local tax authorities, some of which are aggressively pursuing taxes on transferred or discontinued local operations
Ongoing audits may challenge taxes on transferred or discontinued local operations and create costly compliance and uncertain liabilities.
Dropped
- DroppedRisks Related to Manufacturing, IT Systems, Commercial Operations and Plans for Future Growth
We may not be able to realize the anticipated benefits from acquisitions, which could adversely affect our operating results
- DroppedRisks Related to Manufacturing, IT Systems, Commercial Operations and Plans for Future Growth
Our business depends on our ability to market effectively to dealers of home healthcare products, sleep clinics, and physicians
- DroppedRisks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts
Tax 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
Reworded
- 66% rewrittenRisks Related to Our Business and Industry
Consolidation in the healthcare industry and healthcare payment reform could have an adverse effect on our revenues and results of operations
The risk now names third-party payors and strategic alliances as consolidation drivers, but drops explicit statements about price cuts reducing revenues and earnings.
- 60% rewrittenRisks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts
Our 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
The risk no longer mentions artificial intelligence, leaving the regulatory, recall, compliance and enforcement concerns otherwise unchanged.
- 53% rewrittenRisks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts
We are subject to substantial regulation related to quality standards applicable to our manufacturing and quality processes
The risk adds February 2026 FDA QMSR implementation, ISO 13485 incorporation and expanded inspection visibility into audits, suppliers and management review.
- 46% rewrittenRisks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts
Healthcare 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
No substantive change is apparent; the ACA, coverage expansion, mandate and industry fees remain described the same way.
- 45% rewrittenRisks Related to Our Business and Industry
We are subject to new areas of direct healthcare oversight by federal government agencies due to our acquisitions of VirtuOx and Noctrix
The risk adds Noctrix as a Medicare-enrolled DME supplier alongside VirtuOx and broadens the stated healthcare-program oversight.
Was: We are subject to new areas of direct healthcare oversight by federal government agencies due to our acquisition of VirtuOx
- 39% rewrittenRisks Related to Our Business and Industry
Our inability to compete with new and existing technology may harm our business
No substantive change is apparent; competition, evolving technology, alternative therapies and potential cures remain described the same way.
Was: Our inability to compete with new and existing technology to treat OSA successfully may harm our business
- 32% rewrittenRisks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts
Government 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
No substantive change is apparent; government and private payors may deny, reduce or inadequately reimburse products and treatments.
- 27% rewrittenRisks Related to Manufacturing, IT Systems, Commercial Operations and Plans for Future Growth
If 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
The risk expands from Residential Care Software to all software solutions and adds that defects may remain undetected before implementation.
- 23% rewrittenRisks Related to Our Business and Industry
If we fail to source, develop and retain key employees, our business may suffer
- 21% rewrittenRisks Related to Our Business and Industry
Our leverage and debt service obligations could adversely affect our business
All 39 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business and Industry
- 01Our inability to compete with new and existing technology may harm our business39% rewritten
- 02Consolidation in the healthcare industry and healthcare payment reform could have an adverse effect on our revenues and results of operations66% rewritten
- 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
- 04Our business, financial condition and results of operations could be harmed by the effects of pandemics, epidemics, or other public health crises
- 05We are subject to various risks relating to international activities that could affect our overall profitability
- 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
- 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
- 08We are subject to potential professional services liability claims due to our recent acquisition of VirtuOx, which may exceed the scope and amount of our insurance coverage, which would expose us to liability for uninsured claimsNew
- 09Our intellectual property may not protect our products, and/or our products may infringe on the intellectual property rights of third parties
- 10If we fail to source, develop and retain key employees, our business may suffer23% rewritten
- 11Our leverage and debt service obligations could adversely affect our business21% rewritten
- 12We are subject to new areas of direct healthcare oversight by federal government agencies due to our acquisitions of VirtuOx and Noctrix45% rewritten
Risks Related to Manufacturing, IT Systems, Commercial Operations and Plans for Future Growth
- 13Disruptions in the supply of components from our suppliers could result in a significant reduction in sales and profitability
- 14We are increasingly dependent on information technology systems and infrastructure
- 15Actual 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
- 16Failure to identify, execute, and integrate acquired businesses into our operations successfully, or challenges related to the Company's strategic initiatives, including divestituresNew
- 17If we are unable to support our continued growth or achieve expected operating efficiencies, our business could suffer
- 18Our business depends on our ability to effectively educate and engage dealers of home healthcare products, sleep clinics and physicians, health care providers, and patients regarding the benefits of our products, software solutions and servicesNew
- 19The 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
- 20If 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 decline27% rewritten
- 21If 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
- 22Climate 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
- 23Healthcare 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 operations46% rewritten
- 24Government 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 products32% rewritten
- 25Our 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
- 26The UK GDPR mirrors the fines under the EU GDPR, i.e., fines up to the greater of approximately £18 million or 4% of global turnover
- 27Our 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 operations60% rewritten
- 28Our use of artificial intelligence in certain products, software solutions and business operations may expose us to operational, regulatory and reputational risks that could adversely affect our business, financial condition and results of operationsNew
- 29Product 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
- 30We are subject to substantial regulation related to quality standards applicable to our manufacturing and quality processes53% rewritten
- 31Disruptions 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
- 32Off-label marketing of our products could result in substantial penalties
- 33Laws regulating consumer contacts could adversely affect our business operations or create liabilities
- 34Income tax laws, regulations, and enforcement practices in various jurisdictions are evolving and, as a result, tax authorities are aggressively pursuing taxpayersNew
- 35We are subject to ongoing tax audits by various local tax authorities, some of which are aggressively pursuing taxes on transferred or discontinued local operationsNew
- 36Sustainability 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
- 37Our quarterly operating results are subject to fluctuation for a variety of reasons
- 38Our ability to sustain or grow dividends or repurchase shares is subject to board discretion
- 39Delaware law and provisions in our charter could make it difficult for another company to acquire us
Other Resmed 10-Ks
- FY2025 10-K risk factors36 risks
Residential Care Software and VirtuOx create added dependence on renewals, uptime, privacy, and healthcare oversight.
Filed Aug 08, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.