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Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, chronic obstructive pulmonary disease, or COPD, and other chronic diseases.
−Removed: Our comprehensive out-of-hospital, or OOH, software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice.
+Added: Our comprehensive residential care software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice.
By enabling better care, our products improve quality of life, reduce the impact of chronic disease, and lower costs for consumers and healthcare systems.
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In addition, we are a leading provider of cloud-based health applications, software and devices designed to provide connected care, enabling clinicians to manage more patients efficiently and effectively, as well as enabling and encouraging patients’ long-term adherence to and satisfaction with their therapy.
−Removed: We also provide management software to agencies providing OOH care, including but not limited to home medical equipment, or HME, home health and hospice, skilled nursing, life plan community, senior living, outpatient therapy and private duty services.
+Added: We also provide management software that assists durable or home medical equipment (DME/HME) providers, and other long-term care providers operate more effectively and efficiently across various residential care settings.
PART I Item 1
AND SUBSIDIARIES
−Removed: We employ over 9,980 people and sell our products in over 140 countries through a combination of wholly owned subsidiaries and independent distributors.
+Added: comprehensive set of software and services offerings, our software solutions enable providers to streamline workflow and deliver an improved patient experience across our existing vertical markets including HME and home infusion, facility-based organizations including skilled nursing, senior living, and life plan communities, home health and hospice providers, and to adjacent providers through a growing portfolio of value-added solutions with broad applicability.
+Added: In May 2025, we acquired VirtuOx, a software-enabled independent diagnostic testing facility, or IDTF, and provider of technology solutions to facilitate in-home and remote testing services for sleep, respiratory, cardiac, and other health conditions across the United States, or U.S.
+Added: This acquisition strengthens our position in the sleep and breathing health market by expanding our ability to offer end-to-end solutions, including home-based diagnostics and patient monitoring.
+Added: VirtuOx will operate as a wholly owned subsidiary of Resmed.
+Added: The acquisition is not material to our financial results.
+Added: We employ more than 10,600 people and sell our products in more than 140 countries through a combination of wholly owned subsidiaries and independent distributors.
Our website address is www.resmed.com.
−Removed: We make our periodic reports, together with any amendments, available on our investor relations website (https://investor.resmed.com), free of charge, as soon as reasonably practicable after we electronically file or furnish the reports with the Securities and Exchange Commission, or SEC.
+Added: We make our periodic reports, together with any amendments, available on our investor relations website (https://investor.resmed.com), free of charge, as soon as reasonably practicable after we electronically file or furnish the reports with the U.S.
+Added: Securities and Exchange Commission, or SEC.
The SEC maintains an internet site, www.sec.gov, which contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.
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Segment Information
−Removed: We operate in two segments, which are the Sleep and Respiratory Care segment and the Software as a Service, or SaaS, segment.
+Added: We operate in two segments, which are the Sleep and Breathing Health segment and Residential Care Software segment.
See Note 13 – Segment Information of the Notes to Consolidated Financial Statements (Part II, Item 8) for financial information regarding segment reporting.
Financial information about our revenues from and assets located in foreign countries is also included in the notes to our consolidated financial statements.
−Removed: We are focused on sleep and related respiratory care, both of which we believe are globally underpenetrated, and where we believe our products can improve patient outcomes, create efficiencies for our customers, help physicians and providers better manage chronic disease and reduce overall healthcare system costs.
−Removed: Additionally, our software solutions are focused on OOH care, which we believe is fragmented and underserved, and where we see significant opportunity to transform and significantly improve OOH healthcare through a strategy of enabling better patient care, improving clinical decision support, and driving interoperability across OOH care settings.
−Removed: Sleep and Respiratory Care
+Added: We are focused on sleep and related breathing health, both of which we believe are globally underpenetrated, and where we believe our products can improve patient outcomes, create efficiencies for our customers, help physicians and providers better manage chronic disease and reduce overall healthcare system costs.
+Added: Additionally, our software solutions are focused on those who provide residential care, which we believe is fragmented and underserved, and where we see significant opportunity to transform and significantly improve residential healthcare through a strategy of enabling better patient care, improving clinical decision support, and driving interoperability across residential care settings.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: Sleep and Breathing Health
Sleep is a complex neurological process that includes two distinct states:
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REM sleep, which is about 20-25% of total sleep experienced by adults, is characterized by a high level of brain activity, bursts of rapid eye movement, increased heart and respiration rates, and paralysis of many muscles.
−Removed: Non-REM sleep is subdivided into four stages that generally parallel sleep depth;
+Added: Non-REM sleep is subdivided into three stages that generally parallel sleep depth;
stage 1 is the lightest and stage 3 is the deepest.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
The upper airway has no rigid support and is held open by active contraction of upper airway muscles.
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Individuals with narrow upper airways or poor muscle tone are prone to temporary collapses of the upper airway during sleep, called apneas, and to near closures of the upper airway called hypopneas.
−Removed: These breathing events result in a lowering of blood oxygen concentration, causing the central nervous system to react to the lack of oxygen or increased carbon dioxide and signaling the body to respond.
+Added: These breathing events result in a lowering of blood oxygen concentration, causing the central nervous system to react to the lack of oxygen or increased carbon dioxide, signaling the body to respond.
Typically, the individual subconsciously arouses from sleep, causing the throat muscles to contract, opening the airway.
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OSA has been recognized as a cause of hypertension and a significant comorbidity for heart disease, stroke, and type 2 diabetes.
−Removed: A long-term epidemiology study published in 2013 estimated that 26% of adults age 30-70 have some form of obstructive sleep apnea.
+Added: A long-term epidemiology study published in 2013 estimated that 26% of adults aged 30-70 have some form of obstructive sleep apnea.
Another study published in Lancet Respiratory Medicine in 2019 estimated that mild to severe OSA impacts more than 936 million people worldwide, including 54 million Americans.
−Removed: Of those impacted, it was estimated that more than 424 million would have moderate to severe sleep apnea.
+Added: Of those impacted globally, it was estimated that more than 424 million would have moderate to severe sleep apnea.
Despite the high prevalence of OSA, there is a general lack of awareness of OSA among both the medical community and the general public.
−Removed: It is estimated that less than 20% of those with OSA have been diagnosed or treated.
+Added: It is estimated that less than 20% of those with OSA have been diagnosed or treated in the U.S., and 10% or less in other markets.
Many healthcare professionals often do not diagnose OSA because they are unaware that such non-specific symptoms as excessive daytime sleepiness, fatigue, snoring, hypertension, and irritability are characteristic of OSA.
−Removed: While sleep apnea has been diagnosed in a small portion of a broad cross-section of the population, until recently, it has typically been diagnosed among middle-aged men with obesity.
+Added: While sleep apnea has been diagnosed in a small portion of a broad cross-section of the population, until recently it has most frequently been diagnosed among middle-aged men with obesity.
However, we believe the importance of sleep apnea in women is increasingly being recognized, with nearly 40% of new PAP patients being female.
−Removed: A strong association has been discovered between sleep apnea and a number of cardiovascular and metabolic diseases.
+Added: Among all patients, a strong association has been discovered between sleep apnea and a number of cardiovascular and metabolic diseases.
Studies have shown that sleep apnea is present in approximately 83% of patients with drug-resistant hypertension, approximately 77% of patients with obesity, approximately 76% of patients with chronic heart failure, and approximately 72% of patients with type 2 diabetes.
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studies have linked OSA to increased occurrences of traffic and workplace accidents.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
Generally, an individual seeking treatment for the symptoms of OSA is referred by a general practitioner to a sleep specialist for further evaluation.
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These tests allow sleep clinicians to detect sleep disturbances such as apneas, hypopneas, or subconscious awakenings.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
Before 1981, the primary treatment for OSA was a tracheotomy, a surgical procedure to create a hole in the patient’s windpipe.
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Other alternative treatments available today include nasal surgery, mandibular advancement surgery, dental appliances, palatal implants, somnoplasty, nasal devices, and electrical stimulation of the nerves or muscles.
−Removed: Alternative pharmaceutical therapy treatments expected to be indicated for OSA treatment are under development.
+Added: Recently, pharmaceutical therapy treatments have been cleared for the treatment of OSA and others are reportedly under development.
A variety of devices are marketed for the treatment of OSA.
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CPAP was first used as a treatment for OSA in 1980 by Dr.
−Removed: Colin Sullivan, the past Chairman of our Medical Advisory Board, and was commercialized for treatment of OSA in the United States, or U.S., in the mid-1980s.
+Added: Colin Sullivan, the past Chairman of our Medical Advisory Board, and was commercialized for treatment of OSA in the U.S.
+Added: in the mid-1980s.
During CPAP treatment, a patient sleeps with an interface connected to a small portable air device that delivers room air at a positive pressure.
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and auto-titration devices that modulate the average pressure delivered during the night.
−Removed: Respiratory Care
−Removed: Our aim is to provide respiratory care solutions to patients with COPD and other chronic respiratory diseases, such as overlap syndrome, obesity hypoventilation syndrome, or OHS, and neuromuscular disease, including amyotrophic lateral sclerosis, or ALS.
+Added: We also offer myAir, a patient engagement application that provides sleep data and a daily score based on a user's previous night’s data to improve compliance.
+Added: Breathing Health
+Added: Our aim is to provide breathing health solutions to patients with COPD and other chronic respiratory diseases, such as overlap syndrome, obesity hypoventilation syndrome, or OHS, and neuromuscular disease, including amyotrophic lateral sclerosis, or ALS.
We aim to improve patient quality of life, slow down disease progression and reduce the costs of patient management.
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Our devices are predominantly used in the home and, to a lesser extent, in general hospital wards and respiratory wards.
−Removed: We supply CPAP and bilevel device systems, high flow therapy device systems (HFT), non-invasive and invasive ventilators, humidifiers, and accessories, including masks, nasal cannula, and tubing.
+Added: We supply CPAP and bilevel device systems, high flow therapy device systems (HFT), non-invasive and invasive ventilators, humidifiers, and accessories, including masks, nasal cannula, headgear, and tubing.
We also provide data management systems designed to improve the management of patients by care providers.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
Chronic Obstructive Pulmonary Disease.
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Patients with chronic bronchitis present with low level of oxygen (hypoxemia) and elevated levels of carbon dioxide (hypercapnia), a chronic productive cough, cor pulmonale, and commonly have excess weight.
−Removed: Patients with emphysema have more normal blood gases, are usually thin and hyperinflated
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: and have a decreased diffusion capacity.
+Added: Patients with emphysema have more normal blood gases, are usually thin and hyperinflated and have a decreased diffusion capacity.
During sleep, chronic bronchitic patients display more severe hypoxemia.
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Studies have demonstrated that patients with Duchenne muscular dystrophy may improve in quality of life measures and may increase chance of survival with NIV treatment.
−Removed: Software as a Service
−Removed: Due to multiple acquisitions, including Brightree in April 2016, HEALTHCAREfirst in July 2018, MatrixCare in November 2018, and MEDIFOX DAN in November 2022, our operations now include software platforms that comprise our SaaS business.
−Removed: Our SaaS strategy is to develop a portfolio that assists durable or home medical equipment (DME/HME) providers, and other long-term care providers operate more effectively and efficiently across various OOH care settings.
−Removed: With a comprehensive set of software and services offerings, our SaaS solutions enable providers to streamline workflow and deliver an improved patient experience across our existing vertical markets including HME and home infusion, facility-based organizations including skilled nursing, senior living, and life plan communities, home health and hospice providers, and to adjacent providers through a growing portfolio of value-added solutions with broad applicability.
−Removed: Our offerings can help providers perform analytics, manage documentation and implement new reimbursement requirements as well as more effectively transfer data as patients move between different care settings.
−Removed: Business Strategy
−Removed: We believe the treatment of sleep apnea and respiratory care will continue to grow due to a number of factors, including increasing awareness of OSA, CSA and COPD;
−Removed: improved understanding of the role of sleep apnea treatment in the management of cardiac, neurologic, metabolic, and related disorders;
−Removed: improved understanding of the role of non-invasive
+Added: Residential Care Software
+Added: Our Residential Care Software business provides cloud-based solutions to healthcare providers operating in the residential care market, including HME and home infusion providers, home health and hospice providers, skilled nursing facilities, private duty nursing organizations, senior living facilities, and life plan communities.
+Added: These providers face increasing operational and compliance complexities due to factors such as evolving reimbursement frameworks, workforce constraints, and demographic shifts.
+Added: Our Residential Care Software offerings are designed to support customers in addressing these challenges by helping providers perform analytics, manage documentation and implement new
PART I Item 1
AND SUBSIDIARIES
−Removed: ventilation in the management of COPD;
+Added: reimbursement requirements as well as more effectively transfer data as patients move between different care settings.
+Added: Our Residential Care Software platforms include capabilities for billing and business management, electronic medical records, revenue cycle management, operational analytics, patient engagement, and workforce management.
+Added: Business Strategy
+Added: We envision a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home.
+Added: We believe the sleep and breathing treatments will continue to grow due to a number of factors, including increasing awareness of OSA, CSA and COPD;
+Added: improved understanding of the role of sleep apnea treatment in the management of adjacent pathologies;
+Added: improved understanding of the role of bilevel therapy and non-invasive ventilation in the management of COPD;
and an increase in the use of digital and product technology to improve patient outcomes and create efficiencies for customers and providers.
−Removed: Our strategy for expanding our business operations and capitalizing on the growth of the sleep apnea and respiratory care, as well as growth in OOH care settings, consists of the following key elements:
−Removed: • Continue Product Development and Innovation in Sleep Apnea and Respiratory Care Products.
−Removed: We are committed to ongoing innovation in developing products for the diagnosis and treatment of sleep apnea.
−Removed: We have been a leading innovator of products designed to treat sleep apnea more effectively, increase patient comfort, convenience, and encourage compliance with prescribed therapy.
−Removed: We have introduced a full suite of masks in our AirFit and AirTouch and other ranges, and we offer advanced and expanded integrations of our therapy-based software solutions used by providers, including AirView, to promote greater patient adherence to therapy.
−Removed: Our acquisitions have also included adding a portfolio of sleep apnea products such as through our acquisition of Curative Medical in 2015.
−Removed: Likewise, we are committed to ongoing innovation of our respiratory care products that serve the needs of patients with COPD and neuromuscular diseases, providing advanced and expanded integrations of our therapy-based software solutions including AirView for Respiratory Care, enabling clinicians to remotely monitor patients on some ventilation devices and bilevel devices.
−Removed: • Broaden our Digital Health Technology Foundation.
−Removed: Digital enablement is central to our strategy.
−Removed: Our secure cloud-based digital health applications, along with our devices, are designed to provide connected care to improve patient outcomes and efficiencies for our customers, allowing fewer professionals to manage more patients and empowering patients to track their own health outcomes.
−Removed: We are expanding our cloud-based patient management and engagement platforms, such as AirView, enabling remote monitoring, over-the-air trouble shooting and changing of device settings, U-Sleep enabling automated patient coaching through a text, email or interactive voice phone call and myAir, a patient engagement application that provides sleep coaching and a daily score based on users' sleep data.
−Removed: In the United States we have released ResMed MaskSelector, an easy-to-use digital tool to make ResMed mask selection and sizing easier for patients and more effective for providers.
−Removed: Sleep is becoming a more important aspect of our customers' lives.
−Removed: We believe increased adoption of wearables with sleep monitoring functionality will drive more sleep-concerned consumers into care pathways.
−Removed: We believe that the combination of continued product development, product and technology acquisitions and innovation are key factors of our ongoing success.
−Removed: Approximately 19% of our employees are devoted to research and development activities.
−Removed: • Expand SaaS Solutions in Out-of-Hospital Care Settings.
−Removed: Our vision is to transform and significantly improve OOH healthcare through a strategy of enabling better patient care, improving clinical decision support, and driving interoperability across OOH healthcare settings.
−Removed: Since acquiring Brightree in 2016, plus MatrixCare and HEALTHCAREfirst in 2018, we offer software solutions across multiple OOH healthcare settings including HME, home health and hospice, skilled nursing, life plan communities, senior living, and private duty.
−Removed: Our acquisition of MEDIFOX DAN in 2022 expanded ResMed’s SaaS business to Germany and added new OOH care sectors to our ecosystem, including outpatient therapy.
−Removed: We are connecting capabilities across the platforms in these OOH care settings to help our customers be more efficient, better serve people, keep them out of hospital, and provide care in lower-cost, higher-quality care settings.
−Removed: Today, our SaaS solutions support out of hospital providers serving over 150 million individual patient accounts.
−Removed: • Expand Geographic Presence.
−Removed: We offer our products in more than 140 countries to sleep clinics, home healthcare dealers, patients and third-party payors.
−Removed: We intend to increase our sales and marketing efficiency in our principal geographies, as well as expand the depth of our presence in other high-growth geographic regions.
−Removed: In 2015, we acquired Curative Medical to invest in China and expand our growth potential in sleep apnea, COPD and respiratory care there.
−Removed: In 2019, we acquired HB Healthcare, a privately owned HME that serves both reimbursed and cash-pay customers of sleep and respiratory care devices in South Korea.
−Removed: In 2021, we acquired Tong-il, another leading sleep and respiratory care HME provider in South Korea, reinforcing both our commitment and capability to serve South Koreans living with sleep apnea, COPD, and other chronic respiratory diseases.
−Removed: • Increase Public and Clinical Awareness.
−Removed: We continue to expand our existing promotional activities to increase awareness of sleep apnea, COPD, and other clinical conditions that can be treated with our industry-leading solutions.
−Removed: These promotional activities target both the population predisposed to sleep apnea and medical specialists, such as pulmonologists, sleep medicine specialists, primary care physicians, cardiologists,
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: neurologists, and other medical subspecialists who treat these conditions and their associated comorbidities.
+Added: Our strategy for expanding our business operations and capitalizing on the growth of sleep and breathing health markets, as well as growth in residential care settings, consists of the following key elements:
+Added: • Grow and Differentiate Our Core Sleep Apnea Portfolio.
+Added: We are the leader in developing smaller, quieter, more comfortable and more connected products.
+Added: We aim to continue differentiating our products by integrating artificial‑intelligence and machine‑learning, or AI and ML, algorithms to further enhance therapy performance and user experience.
+Added: Sleep is becoming a more important aspect of our customers' lives, and we intend to drive higher rates of screening, diagnosis, and therapy adoption through simpler care pathways.
+Added: In April 2025, we made our home sleep apnea test, NightOwl, available across the U.S., providing a simplified, accurate, and efficient way to diagnose OSA from the comfort of an individual’s home.
+Added: In May 2025, we acquired VirtuOx, an IDTF, to expand our ability to partner with healthcare providers to help streamline the diagnostic process, while expanding collaboration with home medical equipment providers to efficiently support patients to start treatment.
+Added: • Accelerate Market Growth through Awareness.
+Added: We continue to expand our existing educational activities to increase awareness of sleep apnea, COPD, and other clinical conditions that can be treated with our industry-leading solutions.
+Added: These activities target both the population predisposed to sleep apnea and medical specialists, such as pulmonologists, sleep medicine specialists, primary care physicians, cardiologists, neurologists, and other medical subspecialists who treat these conditions and their associated comorbidities.
We target special interest groups, including the National Stroke Association, the American Heart Association, COPD Foundation, and the National Sleep Foundation, to further increase awareness of the relationship between OSA, COPD, neuromuscular disease, and comorbidities such as cardiac disease, diabetes, hypertension, and obesity.
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We have also established a chair for the study of sleep medicine at Harvard Medical School.
−Removed: We believe that recent interest in GLP-1 weight loss drugs will potentially drive additional patients into our treatment funnel, as previously untreated sleep apnea is diagnosed as part of their clinical evaluation.
−Removed: • Expand into New Clinical Applications.
−Removed: We continually seek to identify new applications of our technology for significant unmet medical needs.
−Removed: Studies have established a clinical association between OSA and both stroke and chronic heart failure and have recognized sleep apnea as a cause of hypertension or high blood pressure.
+Added: • Capitalize on Broader Sleep and Breathing Health Adjacencies.
+Added: Our evolution is designed to capitalize on key macro trends, including the enhanced spotlight on sleep apnea due to pharmaceuticals and consumer technology.
+Added: Through our brand leadership and expertise, we are positioned to serve large, unmet needs in insomnia, COPD and other respiratory and related conditions.
+Added: Research supported by Resmed has demonstrated that the addition of non-invasive ventilation to patients with severe COPD who are receiving oxygen therapy provides meaningful clinical benefits to the patient and the broader healthcare system.
+Added: We are committed to ongoing innovation of our breathing health products, providing advanced and expanded integrations of our therapy-based software solutions, including AirView, enabling clinicians to remotely monitor patients on some ventilation devices and bilevel devices.
+Added: Additionally, studies have established a clinical association between OSA and both stroke and chronic heart failure and have recognized sleep apnea as a cause of hypertension or high blood pressure.
Research also indicates that sleep apnea is independently associated with glucose intolerance and insulin resistance.
−Removed: Additionally, research supported by ResMed has demonstrated that the addition of non-invasive ventilation to patients with severe COPD who are receiving oxygen therapy provides meaningful clinical benefits to the patient and the broader healthcare system.
We maintain close working relationships with prominent physicians to explore new medical applications for our products and technology.
−Removed: • Leverage the Experience of our Management Team.
−Removed: Our senior team has extensive experience in the medical device industry in general, and in the fields of sleep apnea, respiratory care and healthcare informatics in particular.
−Removed: We intend to continue to leverage the experience and expertise of these individuals to maintain our innovative approach to the development of products and solutions and to increase awareness of the serious medical problems caused by untreated sleep apnea and the use of non-invasive ventilation, and in-home life-support ventilation to treat COPD and other chronic respiratory diseases.
+Added: • I nvest in an Integrated, Intelligent Digital‑Health Ecosystem Delivered at Home.
+Added: Digital enablement is central to our strategy.
+Added: Our secure cloud-based digital health applications, along with our devices, are designed to provide connected care to improve patient outcomes and efficiencies for our customers, allowing fewer professionals to manage more patients and empowering patients to track their own health outcomes.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: leverage our installed base of more than 30 million patients using cloud‑connected devices on AirView and over 10 million patients registered to our myAir platform to enable personalized, efficient and data‑driven care.
+Added: Our own efforts to drive increased therapy adoption, as well as increased adoption through use of wearables with sleep monitoring functionality, will allow us to further build upon our data advantage.
+Added: • Align Solutions to Enable Smarter, Connected Care.
+Added: Our leading Residential Care Software solutions are a key enabler of our Sleep and Breathing Health business, driving revenue synergies, contributing to demand generation and providing cohesion and interoperability for our AI-driven digital platform.
+Added: We are connecting capabilities across the platforms in these residential care settings to help our customers be more efficient, better serve people, keep them out of hospital, and provide care in lower-cost, higher-quality care settings.
+Added: Today, our Residential Care Software solutions support residential care providers serving more than 160 million individual patient accounts.
Our portfolio of products includes devices, diagnostic products, mask systems, headgear and other accessories, dental devices, and cloud-based software and informatics solutions.
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Masks are a primary determinant of patient comfort and as such may drive or impede patient compliance with therapy.
−Removed: We have been a consistent innovator in small nasal, nasal pillows, and full-face masks, by improving patient comfort while minimizing size and weight.
−Removed: The table below provides an of overview of our mask systems by category.
+Added: We have been a consistent innovator in nasal, nasal pillows, and full-face masks, by improving patient comfort while minimizing size and weight.
+Added: The table below provides an overview of our frontline mask systems by category.
CATEGORY DESCRIPTION
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The features of these masks are focused on minimizing contact with the patient’s face to reduce red marks and irritation.
−Removed: Freedom AirFit N30i, AirFit P30i, and AirFit F30i freedom masks, which feature top-of-head tubing design allowing flexibility to easily switch sleep positions.
−Removed: Ultra Soft The AirTouch F20 and AirTouch N20 masks feature a soft and breathable AirTouch cushion designed to enhance CPAP mask comfort.
−Removed: Universal Fit AirFit F20 and AirFit N20 masks are designed to fit a wide range of faces due to the InfinitySeal silicone cushion that adapts to unique facial contours, which increases comfort, improves the fit and reduces leakage.
+Added: Freedom AirFit N30i, AirFit X30i, AirFit P30i, and AirFit F30i freedom masks, which feature top-of-head tubing design allowing flexibility to easily switch sleep positions.
+Added: Ultra Soft The AirTouch N30i, AirTouch F20 and AirTouch N20 masks feature soft and breathable materials designed to enhance CPAP mask comfort.
+Added: Universal Fit AirFit F20 and AirFit N20 masks are designed to fit a wide range of faces due to the InfinitySeal silicone cushion that adapts to unique facial contours, which increases comfort, improves fit and reduces leakage.
PART I Item 1
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NightOwl A portable, cloud-connected, fully disposable diagnostic device that measures AHI based on derived peripheral arterial tone, actigraphy, and oximetry over several nights.
+Added: A comprehensive sleep lab solution that treats a range of patients, designed to support comfortable, uninterrupted sleep for effective titration.
Connected Solutions and Other Products
We have a suite of products that are designed to allow fewer professionals to manage more patients and empower patients to track their own health outcomes.
−Removed: We are expanding our cloud-based patient management and engagement platforms, such as AirView, enabling remote monitoring, over-the-air trouble shooting, and changing of device settings, U-Sleep enabling automated patient coaching through a text, email, or interactive voice phone call and myAir, a patient engagement application that provides sleep data and a daily score based on a user's previous night’s data.
+Added: We are expanding our cloud-based patient management and engagement platforms, such as AirView and other systems used by providers, enabling remote monitoring, over-the-air trouble shooting, changing of device settings, as well as automated patient coaching through a text, email, or interactive voice phone call and myAir, a patient engagement application that provides sleep data, a daily score based on a user's previous night’s data and coaching for patients.
PRODUCTS DESCRIPTION
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myAir A personalized therapy management application for patients with sleep apnea providing support, education and troubleshooting tools for increased patient engagement and improved compliance.
−Removed: U-Sleep A compliance monitoring solution that enables providers to streamline their sleep programs to achieve better business and patient outcomes.
Connectivity Module A module providing a seamless cellular connection between our compatible ventilation devices (e.g., Astral, Stellar) and our AirView™ system.
−Removed: SaaS Products
−Removed: Following multiple acquisitions, including Brightree in 2016, HEALTHCARE first and MatrixCare in 2018, and MEDIFOX DAN in November 2022, we now provide OOH software products designed to support the professionals and caregivers helping people stay healthy in the home or care setting of their choice.
−Removed: SaaS revenue accounted for approximately 12%, 12%, and 11% of our net revenue in fiscal years 2024, 2023, and 2022, respectively.
+Added: Residential Care Software Products
+Added: We provide Residential Care Software products designed to support the professionals and caregivers helping people stay healthy in the home or care setting of their choice.
+Added: Residential Care Software revenue accounted for approximately 12% of our net revenue in each of fiscal years 2025, 2024, and 2023.
PRODUCTS DESCRIPTION
−Removed: Brightree solutions Brightree enables out-of-hospital care organizations to improve their business performance and deliver better health outcomes.
+Added: Brightree solutions Brightree enables residential care organizations to improve their business performance and deliver better health outcomes.
As an industry-leading cloud-based healthcare IT company, Brightree provides solutions and services for thousands of organizations in home medical equipment and pharmacy, orthotic and prosthetic, and home infusion.
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MatrixCare solutions MatrixCare’s EHR software as a service solutions are used by skilled nursing and senior living providers, life plan communities (CCRCs), and home health and hospice organizations to improve efficiencies and promote a better quality of life for the people they serve.
−Removed: MEDIFOX DAN solutions MEDIFOX DAN’s software solutions are used by out-of-hospital care providers in Germany, especially home health and nursing home providers, and enable providers to achieve operating efficiencies and deliver better patient care and outcomes.
+Added: MEDIFOX DAN solutions MEDIFOX DAN’s software solutions are used by residential care providers in Germany, especially home health and nursing home providers, and enable providers to achieve operating efficiencies and deliver better patient care and outcomes.
Product Development and Clinical Trials
−Removed: We have a strong track record of innovation in the sleep and respiratory care markets.
+Added: We have a strong track record of innovation in the sleep and breathing health markets.
In 1989, we introduced our first CPAP device.
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Studies have established a clinical association between untreated sleep apnea and systemic hypertension, diabetes, coronary artery disease, stroke, atrial fibrillation, chronic heart failure, and mortality.
−Removed: Across the sleep and respiratory care platforms, we support clinical trials in many countries including the United States, Canada, Germany, France, the United Kingdom, Switzerland, Netherlands, Spain, Portugal, Sweden, Denmark, Iceland, Argentina, Chile, China, Republic of Korea, Japan, Malaysia, Singapore, and Australia to develop new clinical applications for our technology.
+Added: Across the sleep and breathing health platforms, we support clinical trials in many countries including the U.S., Canada, Germany, France, the United Kingdom, Switzerland, Netherlands, Spain, Portugal, Sweden, Denmark, Iceland, Argentina, Chile, China, Republic of Korea, Japan, Malaysia, Singapore, and Australia to develop new clinical applications for our technology.
We also continue to support some of the largest sleep apnea studies in history by performing advanced statistical analyses on millions of real-world, de-identified, clinical data points collected through our cloud-connected devices and patient engagement tools.
These studies provide clinical insights around patient management, device settings, and predictors of patient adherence that inform our product development efforts.
−Removed: Some of the more recent real-world studies point to a link between PAP adherence and lower healthcare resource utilization.
+Added: Some of the more recent real-world studies point to a link between PAP adherence and reduced mortality among patients with OSA.
We consult with physicians at major medical centers throughout the world to identify clinical and technological trends in the treatment of sleep apnea, COPD, and the other conditions associated with these diseases.
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United States, Canada, and Latin America.
−Removed: Our products are typically purchased by a home healthcare dealer who then sells the products to the patient.
+Added: Our products are typically purchased by a HME provider who then sells the products to the patient.
The decision to purchase our products, as opposed to those of our competitors, is made or influenced by one or more of the following individuals or organizations:
prescribing practitioners;
−Removed: home healthcare dealers;
+Added: HME providers;
insurers (both private and public);
and patients.
−Removed: In the United States, Canada, and Latin America, our sales and marketing activities are conducted through a field sales organization made up of regional territory representatives, program development specialists and regional sales directors.
−Removed: Our field sales organization markets and sells products to home healthcare dealer branch locations throughout the United States, Canada, and Latin America.
+Added: In the U.S., Canada, and Latin America, our sales and marketing activities are conducted through a field sales organization made up of regional territory representatives, program development specialists and regional sales directors.
+Added: Our field sales organization markets and sells products to HME provider branch locations throughout the U.S., Canada, and Latin America.
We also directly educate physicians and sleep clinics about our products.
−Removed: Patients who are diagnosed with OSA or another respiratory condition and prescribed our products are typically referred by the diagnosing physician or sleep clinic to a home healthcare dealer to fill the prescription.
−Removed: The home healthcare dealer, in consultation with the referring practitioner, will assist the patient in selecting the equipment, fit the patient with the appropriate mask and set the device pressure to the prescribed level.
−Removed: Our SaaS solutions are sold to providers of healthcare in various OOH settings.
−Removed: We market and sell our Brightree business management software and service solutions to providers in the United States.
+Added: Patients who are diagnosed with OSA or another respiratory condition and prescribed our products are typically referred by the diagnosing physician or sleep clinic to a HME provider to fill the prescription.
+Added: The HME provider, in consultation with the referring practitioner, will assist the patient in selecting the equipment, fit the patient with the appropriate mask and set the device pressure to the prescribed level.
+Added: Our Residential Care Software solutions are sold to providers of healthcare in various residential care settings.
+Added: We market and sell our Brightree business management software and service solutions to providers in the U.S.
Our primary markets are HME, pharmacy, home infusion, orthotics and prosthetics.
11 unchanged sentences
We select independent distributors in each country based on their knowledge of respiratory medicine and a commitment to treatment of sleep apnea with our therapy.
−Removed: In countries where we sell our products direct, a local senior manager is responsible for direct national sales.
−Removed: In many countries, we sell our products to home healthcare dealers or hospitals who then sell the products to the patients.
+Added: In countries where we sell our products directly, a local senior manager is responsible for direct national sales.
+Added: In many countries, we sell our products to HME providers or hospitals who then sell the products to the patients.
In Germany, Australia, New
2 unchanged sentences
Zealand, and South Korea, we also operate home healthcare businesses, providing products and services directly to patients through a vertically integrated network.
−Removed: We only sell our SaaS products in the United States and Germany.
+Added: We only sell our Residential Care Software products in the U.S.
Manufacturing
5 unchanged sentences
We generally manufacture to our internal sales forecasts and fill orders as received.
−Removed: We strive for continuous improvement in manufacturing processes to deliver year-on-year improvement in output, cost, and product quality.
+Added: We strive for continuous improvement in manufacturing processes to deliver year-on-year improvement in quality, availability and value.
Each manufacturing site and team are responsible for the quality of their product group and decisions are based on performance and quality measures, including customer feedback.
−Removed: The most disruptive effects of the COVID-19 pandemic are behind us and the global recall instituted by one of our major competitors continues to drive global demand for our devices.
−Removed: We continue to be impacted by periodic transport disruptions and supply constraints on certain raw materials and electronic components, including semiconductor chips.
−Removed: These disruptions and constraints have impacted and may continue to impact our ability to manufacture products in quantities and the time necessary to satisfy global customer demand, which could negatively impact our results of operations.
−Removed: Our quality management system is based upon the requirements of ISO 13485, FDA Quality Management System Regulation (formerly the Quality System Regulation for Medical Devices), European Medical Device Regulation (“MDR”), the Medical Device Directive (93/42/EEC) and other applicable regulations for the markets in which we sell.
+Added: Resmed's supply chain may be impacted by periodic transport disruptions and supply constraints on certain raw materials and electronic components, including semiconductor chips and magnets.
+Added: Such disruptions or constraints impact our ability to manufacture products in quantities and in the time necessary to satisfy global customer demand, which could negatively impact our results of operations.
+Added: Further, we source many components and materials for our products from and manufacture our products in various countries.
+Added: Changes to trade policy, including tariff measures introduced in February 2025, may drive new inflation risks in our supply chain for these components and materials.
+Added: On April 5, 2025, U.S.
+Added: Customs and Border Protection issued a Notice of Implementation confirming that current tariff relief for products like ours continues.
+Added: The current impact of global tariffs is dynamic, however.
+Added: If reciprocal tariffs go into widespread effect, they could have a material impact on our business and financial statements through interruption of supply chains, increases in our costs as our suppliers deal with an uncertain global trade environment or an increase or disruption of global shipping.
+Added: Our quality management system is based upon the requirements of ISO 13485, Food and Drug Administration, or FDA, Quality System Regulation, or QSR, being replaced by the new FDA Quality Management System Regulation, or QMSR, effective February 2, 2026, European Medical Device Regulation, or MDR, the Medical Device Directive (93/42/EEC) and other applicable regulations for the markets in which we sell.
Our main manufacturing sites are certified to ISO 13485 and are audited at regular intervals by a Notified Body.
Additionally, our Sydney, Tuas, San Diego, Atlanta, and Moreno Valley sites are certified under the Medical Device Single Audit Program or MDSAP, an audit of medical device manufacturers’ quality management system to satisfy multiple regulatory requirements.
−Removed: MDSAP audits are conducted by a MDSAP recognized auditing organization and can fulfill the needs of multiple regulatory jurisdictions (e.g., Australia, Brazil, Canada, Japan, and the United States of America).
−Removed: Our Sydney manufacturing operation operates an Environmental Management System (EMS) certified to ISO 14001:2015.
+Added: MDSAP audits are conducted by a MDSAP recognized auditing organization and can fulfill the needs of multiple regulatory jurisdictions (e.g., Australia, Brazil, Canada, Japan, and the U.S.).
+Added: Our Sydney and Singapore manufacturing operations operate an Environmental Management System (EMS) certified to ISO 14001:2015.
We are progressively extending the EMS across our manufacturing network.
2 unchanged sentences
Chatsworth, California;
+Added: Calabasas, California;
Johor Bahru, Malaysia;
7 unchanged sentences
In Germany and Korea, we receive payments directly from these payors.
−Removed: While we do not generally receive direct payments for our products from payors in other countries, our success depends on the ability of patients to obtain coverage and our customers to obtain adequate reimbursement from those payors.
−Removed: In the United States, our products are purchased primarily by home healthcare dealers, health systems, or sleep clinics, who invoice third-party payors directly for reimbursement.
−Removed: Domestic third-party payors include government payors such as Medicare and Medicaid and commercial health insurance plans.
−Removed: These payors may deny coverage and reimbursement if they determine that specific defined coverage criteria are not met or that a device is not used in accordance with certain covered treatment methods, or is experimental, or not deemed reasonable and necessary.
−Removed: The long-term trend towards cost-containment, through managed healthcare, or other legislative proposals to reform healthcare, could control or significantly influence the purchase of healthcare services and products and could result in lower prices for our products.
+Added: While we do not generally receive direct payments for our products from payors in other countries, our success largely depends on the ability of patients to obtain coverage and our customers to obtain adequate reimbursement from those payors.
PART I Item 1
AND SUBSIDIARIES
−Removed: countries, such as France, Germany, and Japan, government reimbursement is currently available for the purchase or rental of our products, subject to constraints such as price controls or unit sales limitations.
+Added: In the U.S., our products are purchased primarily by HME providers, health systems, or sleep clinics, who invoice third-party payors directly for reimbursement.
+Added: Domestic third-party payors include government payors such as Medicare and Medicaid and commercial health insurance plans.
+Added: These payors may deny coverage and reimbursement if they determine that specific defined coverage criteria are not met or that a device is not used in accordance with certain covered treatment methods, or is experimental, or not deemed reasonable and necessary.
+Added: Additionally, our recent acquisition of VirtuOx will now require us to bill both commercial and governmental payors in the U.S.
+Added: for diagnostic testing and interpretation services.
+Added: As an IDTF, VirtuOx is subject to various enrollment, coverage and billing requirements by Medicare, state Medicaid Programs, other governmental payors, and commercial health insurance plans.
+Added: Payors may deny coverage and reimbursement for VirtuOx’s services if they determine that specific defined coverage criteria are not met or that the services are not medically necessary.
+Added: VirtuOx experiences frequent government payor audits and while we believe that our billing is appropriate, such audits incur business expenses and decisions may not always be favorable.
+Added: The long-term trend towards cost-containment, through managed healthcare, or other legislative proposals to reform healthcare, could control or significantly influence the purchase of healthcare services and products and could result in lower prices for our products and services.
+Added: In some countries, such as France, Germany, and Japan, government reimbursement is currently available for the purchase or rental of our products, subject to constraints such as price controls or unit sales limitations.
In Australia, China, and some other countries, there is currently limited or no reimbursement for devices that treat OSA.
−Removed: Healthcare reform in the United States continues to bring significant changes to the third-party payor landscape.
+Added: Healthcare reform in the U.S.
+Added: continues to bring significant changes to the third-party payor landscape.
The DMEPOS Competitive Bidding Program was mandated by Congress through the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
7 unchanged sentences
As a result, these products are currently subject to a temporary gap period during which any Medicare-enrolled DMEPOS suppliers may furnish DMEPOS items and services to patients.
−Removed: Payment for Medicare-enrolled DMEPOS suppliers in former CBAs are based on 100% of the single payment amount, for the CBA increased by the projected percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) from January 2023 to January 2024.
−Removed: At some time in the future we expect that CMS will start bidding for the next round of the DMEPOS Competitive Bidding Program after the agency completes the formal public notice and comment rulemaking process.
−Removed: As of January 1, 2024, for items furnished in non-CBAs, fees are based on fully-adjusted rates per the applicable methodology under Code of Federal Regulations Title 42 414.210 (g).
+Added: Payment for Medicare-enrolled DMEPOS suppliers in former CBAs is based on 100% of the single payment amount, for the CBA increased by the projected percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) from January 2023 to January 2024.
+Added: The temporary gap period for all DMEPOS CBPs has recently ended with the announcement of new regulations reinstating competitive bidding in the U.S.
+Added: As a consequence, we expect that CMS will initiate the next round of the DMEPOS Competitive Bidding Program after the agency completes the formal public notice and comment rulemaking process.
+Added: For items furnished in non-CBAs, fees are based on fully-adjusted rates per the applicable methodology under Code of Federal Regulations Title 42 414.210 (g).
Other legislative changes have been proposed and adopted since the Affordable Care Act (ACA) was enacted.
1 unchanged sentence
The Protecting Medicare and American Farmers From Sequester Cuts Act was signed into law December 10, 2021.
−Removed: The law extended the 2% Medicare sequester moratorium through March 31, 2022, adjusted the sequester to 1% between April 1, 2022, and June 30, 2022, and reinstated the full 2% sequestration cut which began on July 1, 2022.
+Added: The law extended the 2% Medicare sequester moratorium through March 31, 2022, adjusted the sequester to 1% between April 1, 2022, and June 30, 2022, and reinstated the full 2% sequestration cut which began on July 1, 2022 and continues until further notice.
The payment reduction applicable to healthcare providers applies to the approved Medicare payment amount, after the deductible and coinsurance are applied.
The reduction in payment does not affect the 20% coinsurance owed by the patient.
−Removed: Additionally, in 2022, the Department of Veterans Affairs (VA) proposed an adjustment through regulation to amend the previously adopted schedule of VA ratings for sleep apnea.
+Added: The sequestration order covers all payments for services with dates of service on or after July 1, 2022.
+Added: On March 9, 2024, President Biden signed the Consolidated Appropriations Act, 2024,
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: which included a 2.93% update to the CY 2024 Physician Fee Schedule (PFS) Conversion Factor (CF) for dates of service March 9 through December 31, 2024.
+Added: This replaced the 1.25% update provided by the Consolidated Appropriations Act of 2023.
+Added: On November 1, 2024, CMS issued a rule finalizing changes for Medicare payments under the PFS and other Medicare Part B policies, effective on or after January 1, 2025.
+Added: Under this final rule, the average payment rates under the PFS would be reduced by 2.93% in CY 2025, removing the temporary increase in payment for CY 2024.
+Added: This amounts to an estimated CY 2025 PFS conversion factor of $32.35, a decrease of $0.94 from the CY 2024 conversion factor of $33.29, resulting in lower Medicare payments to Part B suppliers.
+Added: As discussed immediately below, however, the One Big Beautiful Bill Act includes a 1-year, 2.5% increase to the PFS for 2026, which temporarily addresses the 2025 payment cuts.
+Added: Most recently, on July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the Bill), which among other things, cuts federal Medicaid funding by $930 billion over ten years but provides reimbursement rate increases for providers.
+Added: Notably, however, the Bill is projected to increase the federal deficit, which may lead to mandatory Medicare cuts and reduction in payments to providers in the future.
+Added: The Bill also makes changes to the ACA that could reduce enrollment, including shortening enrollment periods and eliminating automatic re-enrollment.
+Added: Additionally, in 2022, the Department of Veterans Affairs, or VA, proposed an adjustment through regulation to amend the previously adopted schedule of VA ratings for sleep apnea.
Specifically, the proposed rule would remove in its entirety the current 30% disability rating for veterans exhibiting excessive daytime sleepiness and instead replacing it with a 10% disability rating for veterans with a sleep apnea diagnosis with incomplete relief (as determined by a sleep study) with treatment including a CPAP machine, and further, remove the automatic 50% disability rating for veterans with a documented need for a CPAP machine (50% disability would instead require that the veteran have a sleep apnea diagnosis with ineffective treatment, as determined by a sleep study, or who is unable to use treatment due to comorbid conditions, without end-organ damage).
−Removed: The VA has not yet adopted these changes to the disability ratings system for sleep apnea but should this proposal, or another similar proposal to limit disability ratings be adopted, fewer veterans may pursue treatment of sleep apnea using CPAP or more veterans would claim ineffective treatment with CPAP to obtain the higher rating.
+Added: The VA has not yet changed its ratings criteria but it could happen in calendar year 2025.
+Added: If the changes are implemented, veterans who were rated for sleep apnea before the change in criteria will be grandfathered and retain their rating.
+Added: However, all veterans filing new claims on and after the change in ratings criteria would be evaluated under the new criteria.
+Added: The VA has not yet adopted these changes to the disability ratings system for sleep apnea but should this proposal, or another similar proposal to limit disability ratings be adopted, fewer veterans may pursue treatment of sleep apnea using CPAP or more veterans would claim ineffective treatment with CPAP to obtain a higher rating.
The legislative landscape is complex and changes with the influence of one party or the other.
−Removed: We expect that the ACA, these new laws and other healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for our products and services.
+Added: The Trump Administration has issued many executive orders and new policy initiatives in 2025, including those impacting the healthcare and life sciences industry.
+Added: We expect that new legislation, agency rules, and policy changes, including potential changes to the ACA, Medicaid funding, and other healthcare reform measures including flow down impacts from the Bill, may be adopted in the future and may result in additional reductions in Medicare, Medicaid and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for our products and services.
Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: implementation of cost containment measures or other healthcare reforms may have a material adverse impact on our revenues, profit margins, profitability, operating cash flows and results of operations.
+Added: The implementation of cost containment measures or other healthcare reforms may have a material adverse impact on our revenues, profit margins, profitability, operating cash flows and results of operations.
Service and Warranty
5 unchanged sentences
We believe that the level of returns experienced to date is consistent with levels typically experienced by manufacturers of similar devices.
−Removed: We provide for warranties and returns based on historical data.
+Added: We record reserves for warranties and returns based on historical data.
Global competition for sales of our products and services is intense.
2 unchanged sentences
We compete in various geographies, each with different competitors, and some of our competitors are affiliates of our customers, which may make it difficult to compete with them.
−Removed: Our primary Sleep and Respiratory Care competitors include Philips BV;
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: Our primary Sleep and Breathing Health competitors include Philips BV;
Fisher & Paykel Healthcare Corporation Limited;
3 unchanged sentences
React Health Corporation;
−Removed: and Lowenstein plus regional and new-entrant manufacturers.
−Removed: Finally, our products compete with surgical procedures, nerve stimulation devices, and dental appliances designed to treat OSA and other sleep apnea-related respiratory conditions.
+Added: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd, and Lowenstein Medical SE & Co.
+Added: KG plus regional and new-entrant manufacturers.
+Added: Our products compete with surgical procedures, nerve stimulation devices, and dental appliances designed to treat OSA and other sleep apnea-related respiratory conditions.
The adoption of new pharmaceuticals to treat obesity, a typical comorbidity of OSA, could impact our ongoing or future sales.
−Removed: The development of new or innovative procedures, devices, or therapies by others could result in our products becoming obsolete or noncompetitive, which would harm our revenues and financial condition.
−Removed: For our SaaS business, competition is also intense, rapidly evolving, and subject to changing technology, low barriers to entry, shifting customer needs, and frequent introductions of new products and services.
+Added: For example, injectable glucagon-like peptide-1, or GLP-1, weight loss drugs may lower the occurrence of obesity, eventually reducing the severity of OSA, if significant weight loss is maintained.
+Added: Injectable weight loss drugs have been approved for treatment of OSA in patients with obesity and moderate to severe OSA and are being marketed by physicians and to consumers.
+Added: Oral versions of these drugs are reportedly under development and may be approved for the treatment of OSA.
+Added: The development of new or innovative drugs, procedures, devices, or alternative therapies by others could result in our products becoming obsolete or noncompetitive, which would harm our revenues and financial condition.
+Added: For our Residential Care Software business, competition is also intense, rapidly evolving, and subject to changing technology, low barriers to entry, shifting customer needs, and frequent introductions of new products and services.
Many of our customers use systems developed in-house to run their businesses.
10 unchanged sentences
Patents and designs have various statutory terms based on the legislation in individual jurisdictions which may be subject to change.
−Removed: Of our patents, approximately 612 U.S.
−Removed: patents and approximately 1,507 foreign patents are due to expire in the next five years.
+Added: Of our patents and designs, approximately 640 U.S.
+Added: patents and designs and approximately 1,450 foreign patents and designs are due to expire in the next five years.
We believe that the expiration of these patents will not have a material adverse impact on our competitive position.
4 unchanged sentences
Therefore, there can be no assurance that patent issues will be uniformly resolved, or that local laws will provide us with consistent rights and benefits.
+Added: Government Regulations
+Added: Our products are subject to extensive regulation particularly as to safety, efficacy and adherence to FDA QSR, and related manufacturing standards.
+Added: Medical device products are subject to rigorous FDA and other governmental agency regulations in the U.S.
+Added: and similar regulations of foreign agencies abroad.
+Added: The FDA regulates the design, development, research, preclinical and clinical testing, introduction, manufacture, advertising, labeling, marking, packaging, marketing, distribution, import and export, and record keeping for our products, in order to ensure that medical products distributed in the U.S.
+Added: are safe and effective for their intended use.
+Added: In addition, the FDA is authorized to establish special controls to
PART I Item 1
AND SUBSIDIARIES
−Removed: Government Regulations
−Removed: Our products are subject to extensive regulation particularly as to safety, efficacy and adherence to FDA Quality System Regulation, and related manufacturing standards.
−Removed: Medical device products are subject to rigorous FDA and other governmental agency regulations in the United States and similar regulations of foreign agencies abroad.
−Removed: The FDA regulates the design, development, research, preclinical and clinical testing, introduction, manufacture, advertising, labeling, marking, packaging, marketing, distribution, import and export, and record keeping for our products, in order to ensure that medical products distributed in the United States are safe and effective for their intended use.
−Removed: In addition, the FDA is authorized to establish special controls to provide reasonable assurance of the safety and effectiveness of most devices.
+Added: provide reasonable assurance of the safety and effectiveness of most devices.
Non-compliance with applicable requirements can result in import detentions, fines, civil and administrative penalties, injunctions, suspensions or losses of regulatory approvals, recall or seizure of products, operating restrictions, refusal of the government to approve product export applications or allow us to enter into supply contracts, and criminal prosecution.
−Removed: Unless an exemption applies, the FDA requires that a manufacturer introducing a new medical device or a new indication for use of an existing medical device obtain either a Section 510(k) premarket notification clearance, a premarket approval, or PMA, or a de novo approval, and pay a user fee, before introducing it into the U.S.
+Added: Unless an exemption applies, the FDA requires that a manufacturer introducing a new medical device, certain modifications thereof, or a new indication for use of an existing medical device obtain either a Section 510(k) premarket notification clearance, a premarket approval, or PMA, or a de novo approval, and pay a user fee, before introducing it into the U.S.
The type of marketing authorization is generally linked to the classification of the device, as well as whether or not a similar or “predicate” device exists to support a 510(k) application.
The FDA classifies medical devices into one of three classes (Class I, II or III) based on the degree of risk the FDA determines to be associated with a device and the level of regulatory control deemed necessary to ensure the device’s safety and effectiveness.
−Removed: Certain SaaS applications may be classified as a medical device.
−Removed: Our devices currently marketed in the United States are marketed pursuant to 510(k) pre-marketing clearances and are either Class I or Class II devices.
−Removed: Certain of our SaaS products may be classified as medical devices requiring a pre-marketing clearance or approval while other SaaS products may not be medical devices or will be commercialized under FDA’s current policy of enforcement discretion.
+Added: Certain software products may also be classified as a medical device.
+Added: Our devices currently marketed in the U.S.
+Added: are marketed pursuant to 510(k) pre-marketing clearances and are either Class I or Class II devices.
+Added: Certain of our software products may be classified as medical devices requiring a pre-marketing clearance or approval while others may not be medical devices, are medical devices that are exempt from the 510(k) process, or will be commercialized under FDA’s current policy of enforcement discretion.
The process of obtaining a Section 510(k) clearance generally requires the submission of performance data and may require clinical data, which in some cases can be extensive, to demonstrate that the device is “substantially equivalent” to a predecessor device that was (a) legally marketed in the U.S.
8 unchanged sentences
Medical devices can be marketed only for the indications for which they are cleared or approved.
−Removed: After a device has received 510(k) clearance for a specific intended use, any change or modification that significantly affects its safety or effectiveness, such as a significant change in the design, materials, method of manufacture or intended use, may require a new or approval and payment of an FDA user fee.
+Added: After a device has received 510(k) clearance for a specific intended use, any change or modification that significantly affects its safety or effectiveness, such as a significant change in the design, materials, method of manufacture or intended use, may require a new clearance or approval and payment of an FDA user fee.
The determination as to whether or not a modification could significantly affect the device’s safety or effectiveness is initially left to the manufacturer using available FDA guidance;
1 unchanged sentence
The manufacturer may also be subject to significant regulatory fines or penalties.
−Removed: Any devices we manufacture and distribute pursuant to clearance or approval by the FDA are subject to pervasive and continuing regulation by the FDA and certain state agencies.
+Added: Any devices we manufacture and distribute pursuant to exemption, clearance or approval by the FDA are subject to pervasive and continuing regulation by the FDA and certain state agencies in the U.S.
These include product listing and establishment registration requirements, which help facilitate FDA inspections and other regulatory actions.
As a medical device manufacturer, all of our manufacturing facilities are subject to inspection on a routine basis by the FDA.
−Removed: We are required to adhere to
+Added: We are required to adhere to applicable regulations setting forth detailed cGMP requirements, as set forth in the QSR, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process.
+Added: Noncompliance with these standards can result in, among other things, fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of production, refusal of the government to grant clearance or approval of devices, withdrawal of marketing approvals and criminal prosecutions.
+Added: We believe that our design, manufacturing and quality control procedures comply with the FDA’s regulatory requirements.
+Added: We must also comply with post-market surveillance regulations, including medical device reporting or MDR requirements which require that we review and report to the FDA any incident in which our products may have caused or contributed to
PART I Item 1
AND SUBSIDIARIES
−Removed: applicable regulations setting forth detailed cGMP requirements, as set forth in the QSR, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process.
−Removed: Noncompliance with these standards can result in, among other things, fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of production, refusal of the government to grant clearance or approval of devices, withdrawal of marketing approvals and criminal prosecutions.
−Removed: We believe that our design, manufacturing and quality control procedures are in compliance with the FDA’s regulatory requirements.
−Removed: We must also comply with post-market surveillance regulations, including medical device reporting or MDR requirements which require that we review and report to the FDA any incident in which our products may have caused or contributed to a death or serious injury.
+Added: a death or serious injury.
We must also report any incident in which our product has malfunctioned if that malfunction would likely cause or contribute to a death or serious injury if it were to recur.
2 unchanged sentences
The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including substantial monetary penalties and criminal prosecution.
−Removed: Sales of medical devices outside the United States are subject to regulatory requirements that vary widely from country to country.
+Added: Sales of medical devices and software outside the U.S.
+Added: are subject to regulatory requirements that vary widely from country to country.
In the European Economic Area, (which is comprised of the 27 member states of the European Union plus Norway, Iceland and Liechtenstein), or EEA, medical devices need to comply with specific requirements.
10 unchanged sentences
All manufacturers placing medical devices into the market in the EEA must comply with the EU Medical Device Vigilance System.
−Removed: Under the MDR, incidents must be reported centrally in the European EUDAMED database (although transitional provisions are in place until EUDAMED is fully functional), and manufacturers are required to take Field Safety Corrective Actions, or FSCAs, to prevent or reduce a risk of death or serious deterioration in the state of health associated with the use
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: of a medical device that is already placed on the market.
+Added: Under the MDR, incidents must be reported centrally in the European EUDAMED database (although transitional provisions are in place until EUDAMED is fully functional), and manufacturers are required to take Field Safety Corrective Actions, or FSCAs, to prevent or reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market.
An incident is defined as any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use.
3 unchanged sentences
Where appropriate, our products commercialized in Europe are CE marked and classified as either Class I or Class II.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
On April 5, 2017, the European Parliament passed the MDR, which repeals and replaces the MDD.
24 unchanged sentences
Our devices are sold in multiple countries and often need to be registered with local regulatory bodies such as the Therapeutic Goods Administration in Australia, Health Canada in Canada and CFDA in China.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
Other Healthcare Laws
1 unchanged sentence
The government has interpreted these laws broadly to apply to the marketing and sales activities of manufacturers and distributors like us.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
The federal Anti-Kickback Statute is a criminal statute that prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or providing remuneration, directly or indirectly, in cash or in kind, in exchange for or to induce either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid.
12 unchanged sentences
The federal Civil Monetary Penalties Law prohibits, among other things, the offering or transferring of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by Medicare or a state healthcare program, unless an exception applies.
+Added: As a medical device manufacturer, the beneficiary inducement prohibition under the Civil Monetary Penalties Law did not directly apply to us (unless we engaged in activities that influenced a Medicare or Medicaid beneficiary to select a particular provider, practitioner or supplier);
+Added: however, following our acquisition of VirtuOx, a Medicare supplier, we will be directly subject to the beneficiary inducement prohibition if we provide any remuneration to a Medicare or Medicaid beneficiary that is intended to or that we should know would be likely to influence that beneficiary to select VirtuOx as their supplier.
+Added: The Federal Physician Self-Referral Law, or the Stark Law, 42 U.S.C.
+Added: 1395n, is a strict liability statute that prohibits a physician (or an immediate family member of a physician) who has a financial relationship with an entity from referring patients to that entity for certain designated health services, or DHS, payable by Medicare (and in some cases, Medicaid), unless an exception applies.
+Added: The Stark Law also prohibits such an entity from presenting or causing to be presented a claim to Medicare for DHS provided pursuant to a prohibited referral, and requires the timely refund of collections related to any such prohibited claims.
+Added: While VirtuOx is a Medicare-enrolled supplier, it currently bills only for the following CPT Codes:
+Added: 94762, 95819, 95800, G0399, 93229, 93228, 93268, 93271, 93286, 93224, 93243, 93241, 93247, and 93245.
+Added: None of these codes appear on the CMS DHS Code List, and therefore, we are not currently subject to the Stark Law by virtue of our acquisition of VirtuOx.
+Added: However, we will need to monitor our VirtuOx offerings in the future and if we choose to offer any DHS, we will be subject to the Stark Law.
Additionally, there has been a recent trend of increased federal and state regulation of payments and transfers of value provided to healthcare professionals or entities.
−Removed: The federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, biologicals, and medical devices or supplies that require premarket approval by or notification to the FDA, and for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, to report annually to CMS information related to (i) payments and other transfers of value to teaching hospitals, physicians (as defined by statute) and, as of 2022, physician assistants, nurse practitioners and other practitioners, and (ii) ownership and investment interests held by such providers and their immediate family members.
+Added: The federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, biologicals, and medical devices or supplies that require premarket approval by or notification to the FDA, and for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, to report annually to CMS information related to (i) payments and other transfers of value to teaching hospitals, physicians (as defined by statute) and, as of 2022, physician
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: assistants, nurse practitioners and other practitioners, and (ii) ownership and investment interests held by such providers and their immediate family members.
Applicable manufacturers are required to submit annual reports to CMS.
1 unchanged sentence
Like the Anti-Kickback Statute, a person or entity does not need to have actual knowledge of these statutes or specific intent to violate them in order to have committed a violation.
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
Also, many U.S.
6 unchanged sentences
The scope of the FCPA includes interactions with certain healthcare professionals in many countries, either directly or through our contracted distributors.
+Added: On February 10, 2025, the Trump Administration issued Executive Order “Pausing Foreign Corrupt Practices Act Enforcement to Further American Economic and National Security”, which paused federal investigations and enforcement actions brought under the FCPA for a period of 180 days.
+Added: Subsequently, the Department of Justice issued new FCPA enforcement guidelines ending the temporary pause, emphasizing that enforcement will align with U.S.
+Added: economic interests and national security.
+Added: Most of the conduct chargeable under the FCPA will also constitute crimes under other laws, such as the U.S.
+Added: wire fraud statute and the SEC’s civil enforcement authority.
+Added: Foreign laws prohibiting bribery of a government official will also continue to apply.
Our present and future business has been and will continue to be subject to various other U.S.
6 unchanged sentences
Penalties for violations of HIPAA regulations include significant civil and criminal penalties for each violation.
−Removed: In some of our operations, such as those involving our cloud-based software digital health applications, we are a business associate under HIPAA.
−Removed: Therefore, we are required to comply with the HIPAA Security Rule, Breach Notification Rule and certain provisions of the HIPAA Privacy Rule, as well as the terms of our business associate agreements that we enter into with our covered entity customers.
−Removed: We are limited by HIPAA with respect to our use and disclosure of protected health information created or received through our business associate arrangements and could potentially face significant civil and criminal penalties if the Department of Health and Human Services Office for Civil Rights (OCR), or any state Attorney General, were to determine that we failed to comply with the applicable HIPAA standards.
+Added: In some of our operations, such as those involving our cloud-based software digital health applications, we are a business associate under HIPAA, requiring us to comply with the terms of the business associate agreements we have with our covered entity customers.
+Added: Additionally, by virtue of our acquisition of VirtuOx, and expanded efforts to reach patients seeking treatment, we are also subject to the rules applicable to a covered entity.
+Added: Therefore, we are required to comply with
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: the HIPAA Security Rule, Breach Notification Rule and certain provisions of the HIPAA Privacy Rule.
+Added: We are limited by HIPAA with respect to our use and disclosure of protected health information created or received and could potentially face significant civil and criminal penalties if the Department of Health and Human Services Office for Civil Rights (OCR), or any state Attorney General, were to determine that we failed to comply with the applicable HIPAA standards.
In addition to federal privacy and security regulations, there are a number of state laws governing confidentiality and security of personal information that are applicable to our business.
−Removed: For example, the California Consumer Privacy Act, effective on January 1, 2020, as amended by the California Privacy Rights Act (collectively, the “CCPA”), was the first of a series of state privacy laws designed to provide California residents expanded rights with regard to their personal information.
+Added: For example, the California Consumer Privacy Act, effective on January 1, 2020, as amended by the California Privacy Rights Act, or collectively, the CCPA, was the first of a series of state privacy laws designed to provide California residents expanded rights with regard to their personal information.
The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation.
1 unchanged sentence
CCPA’s implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and the CCPA may increase our compliance costs and potential liability.
−Removed: Further, since 2020, approximately one-quarter of U.S.
−Removed: states have adopted—and other states are proposing to adopt— their own comprehensive data protection laws, with varying implementation dates that began on January 1, 2023.
+Added: Further, since 2020, more than one-third of U.S.
+Added: states have adopted—and other states are proposing to adopt— their own comprehensive data protection laws, with varying implementation dates.
The application of the laws and the requirements contained therein is not uniform.
Although the majority of these omnibus state laws exclude business data, we may be required to undertake additional compliance investment to evaluate the application of these laws to our business and to implement compliance measures and potentially change our business processes.
−Removed: If we are subject to
−Removed: PART I Item 1
−Removed: AND SUBSIDIARIES
−Removed: or affected by HIPAA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.
+Added: If we are subject to or affected by HIPAA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.
In addition to these comprehensive data protection laws, to date, several states have adopted laws specifically regulating the collection, use, storage, and disclosure of biometrics, and additional states are seeking to regulate—and/or restrict the use of—biometrics in the future.
3 unchanged sentences
In addition, the European Union General Data Protection Regulation, or GDPR, went into effect in May 2018.
−Removed: The United Kingdom has adopted the UK General Data Protection Regulation ("UK GDPR");
−Removed: the EU GDPR and UK GDPR are herein referred to as GDPR.
−Removed: The GDPR imposes stringent data protection requirements for the processing of personal data, whenever GDPR applies to such processing, such as processing in the European Economic Area (EEA), or in the UK.
−Removed: The GDPR increased our obligations, for example, by requiring more robust disclosures to individuals, strengthening individual data rights, instituting procedures for mandatory data breach notifications to regulators within a short timeframe, limiting retention periods and secondary use of information (including for research purposes), increasing requirements pertaining to health data and pseudonymized (i.e., key-coded) data and imposing additional obligations when we contract with third party processors in connection with the processing of the personal data.
−Removed: The GDPR also imposes strict rules on the transfer of personal data out of the EEA or UK, including to the United States;
−Removed: recent legal developments in Europe have created complexity regarding such transfers of personal data from the EEA to the United States.
−Removed: For example, the European Commission and the United Kingdom have adopted new standard contractual clauses under which entities may transfer personal data from the European Union and the United Kingdom, which we may be required to implement.
−Removed: We must evaluate such data transfers on a case-by-case basis to ensure continued permissibility under current law and consistent with new standard contractual clauses.
+Added: The United Kingdom, or the UK, has adopted the UK General Data Protection Regulation, or UK GDPR;
+Added: the EU GDPR and UK GDPR are herein collectively referred to as GDPR.
+Added: The GDPR imposes stringent data protection requirements for the processing of personal data, whenever GDPR applies to such processing, such as certain processing in the EEA, or in the UK.
+Added: The GDPR increases our obligations, for example, by requiring more robust disclosures to individuals, strengthening individual data rights, instituting procedures for mandatory data breach notifications to regulators within a short timeframe, limiting retention periods and secondary use of information (including for research purposes), increasing requirements pertaining to health data and pseudonymized (i.e., key-coded) data and imposing additional obligations when we contract with third party processors in connection with the processing of the personal data.
+Added: The GDPR also imposes strict rules on the transfer of personal data out of the EEA or UK, including to the U.S.;
+Added: legal developments continue to create complexity regarding such transfers of personal data from the EEA or UK to the U.S.
+Added: For example, the European Commission and UK standard contractual clauses under which entities may transfer personal data from the European Union and the UK require us to evaluate such data transfers on a case-by-case basis to ensure continued permissibility under current law and consistent with the standard contractual clauses.
GDPR provides that EEA member states and the UK may make their own further laws and regulations limiting the processing of genetic, biometric or health data, which could limit our ability to use and share personal data or could cause our costs to increase and harm our business and financial condition.
−Removed: EEA member states and the UK may modify or impose additional conditions to be able to transmit electronic marketing communications.
Failure to comply with the requirements of GDPR and the applicable national data protection and marketing laws of the EEA member states may result in fines of up to €20.0 million or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties as well as individual claims for compensation.
Further, the UK GDPR also provides for significant data protection fines up to the greater of £17.5 million or 4% of global turnover.
+Added: In addition, EEA member states and the UK may modify or impose additional conditions to be able to transmit electronic marketing communications.
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
Numerous other state, federal and foreign laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of patient health information and other personal information.
5 unchanged sentences
Both the FTC and the OCR have focused on the use of online tracking technologies that collect personal information and protected health information as an enforced priority.
−Removed: The FTC has also identified the use of artificial intelligence (AI) and the potential bias in AI as one of its enforcement and policy priorities, including the use of AI in the healthcare space.
+Added: We intend to continue to comprehensively protect all personal information and to comply with all applicable laws regarding the protection of such information, including with respect to online tracking.
+Added: Compliance with these and any other applicable privacy and data security laws and regulations is a rigorous and time-intensive process, and we may be required to implement additional mechanisms to comply with the new data protection rules.
+Added: With respect to VirtuOx, for instance, we will need to meet HIPAA's requirements for covered entities and support this additional privacy function.
+Added: If we fail to comply with any such laws or regulations, we may face significant fines and penalties that could adversely affect our business, financial condition and results of operations, damage our reputation and customers’ trust.
+Added: Artificial Intelligence, or AI, Laws
Our services and products may use AI now or in the future.
−Removed: We intend to continue to comprehensively protect all personal information and to comply with all applicable laws regarding the protection of such information, including with respect to online tracking, as well as to monitor developments regarding the use of AI that could be relevant to our products and services.
−Removed: Compliance with these and any other applicable privacy and data security laws and regulations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms ensuring compliance with the new data protection rules.
−Removed: If we fail to comply with any such laws or regulations, we may face significant fines and penalties that
+Added: The regulatory landscape for AI is changing rapidly, with both domestic and international activity.
+Added: There is currently no comprehensive federal legislation in the U.S.
+Added: concerning the use, development, or deployment of AI.
+Added: Despite the lack of comprehensive legislation, federal regulators are continuing to pursue AI-related enforcement actions under existing federal laws.
+Added: For example, the Securities and Exchange Commission has pursued several enforcement actions against companies that are alleged to have made false or misleading statements about their AI capabilities, referred to as AI washing, in violation of the Securities Exchange Act.
+Added: In addition to existing federal laws, federal regulators have also issued guidance concerning the use, development, or deployment of AI.
+Added: For example, the FDA has issued a variety of guidance on the regulation of AI tools, including guidance on Software as a Medical Device, or SaMD, and clinical decision support, or CDS, software.
+Added: There are also a number of state laws governing the use, development, or deployment of AI that may be applicable to our business.
+Added: For example, the Colorado AI Act, or the Act, with compliance obligations taking effect on February 1, 2026, regulates the development, substantial modification, or deployment of AI in Colorado.
+Added: The Act regulates the use of high-risk AI systems, defined as systems that make or are a substantial factor in making a decision that has a material legal or similarly significant effect on the provision or denial to any consumer of, or the cost or terms of:
+Added: education enrollment or opportunity, employment or an employment opportunity, a financial or lending service, an essential government service, healthcare services, housing, insurance, or legal services.
+Added: The Act requires periodic impact assessments for high-risk AI systems and mandates the disclosure of algorithmic discrimination events to the State Attorney General.
+Added: A number of other states have enacted laws that are more limited in scope and may impose certain transparency or disclosure obligations.
+Added: In addition, Regulation (EU) 2024/1689 on harmonized rules on artificial intelligence, or the EU AI Act, went into effect in August 2024.
+Added: The EU AI Act aims to establish a comprehensive regulatory framework for AI.
+Added: The EU AI Act prohibits the use of AI systems that present unacceptable risk to fundamental rights or public safety.
+Added: Non-prohibited AI systems may be subject to stringent requirements depending on the level of risk presented, including mandatory risk assessments, transparency obligations, and human oversight.
+Added: Failure to comply with the requirements of the EU AI Act and the applicable national laws of the EU member states may result in fines of up to €35.0 million or up to 7% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties.
+Added: Numerous other countries have adopted or are considering similar frameworks to regulate the use, development, or deployment of AI.
PART I Item 1
AND SUBSIDIARIES
−Removed: could adversely affect our business, financial condition and results of operations, damage our reputation and customers’ trust.
+Added: We intend to continue to monitor developments regarding the use of AI that could be relevant to our products and services, and comply with all applicable laws regarding the use, development, or deployment of AI.
+Added: Compliance with these and any other applicable AI laws and regulations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms ensuring compliance with new AI laws and regulations.
+Added: If we fail to comply with any such laws or regulations, we may face significant fines and penalties that could adversely affect our business, financial condition and results of operations, damage our reputation and customers’ trust.
Human Capital
−Removed: At ResMed, our mission of transforming patient care in the OOH setting through innovative solutions and technology-driven integrated care is achieved by our commitment and continuous efforts in fostering an inclusive environment that creates a strong sense of belonging, which unlocks the potential, skills and creativity of our people.
−Removed: Our Code of Business Conduct & Ethics, Diversity and Inclusion practices and policies on workplace behavior, discrimination and harassment, health and safety, and employee benefits facilitate talent attraction, retention, and development.
+Added: At Resmed, our mission of transforming patient care in the residential setting through innovative solutions and technology-driven integrated care is largely achieved by our continuous efforts to ensure that we prioritize fostering an inclusive environment that helps our people and our patients achieve success.
+Added: Our culture is designed to unlock the potential, skills, engagement and creativity of our people.
+Added: Our Code of Business Conduct & Ethics, values and ethical business practices and policies directly impact workplace behavior and communication, and address discrimination and harassment, health and safety, and employee engagement, supporting talent attraction, retention, and development.
Our board of directors and its committees provide general oversight on a range of our human capital management efforts.
This includes environmental, social, and governance efforts addressed below.
−Removed: As of June 30, 2024, we had approximately 9,980 employees and contingent workers, of which approximately 4,070 were employed in cost of sales activities including areas such as warehousing and manufacturing, 1,870 in research and development and 4,040 in sales, marketing and administration.
−Removed: Of our employees and contingent workers, approximately 3,050 (31%) were located in the United States, Canada and Latin America, 2,980 (30%) in Asia, 1,530 (15%) in Australia and 2,420 (24%) in Europe.
−Removed: We believe that the success of our business will depend, in part, on our ability to attract and retain qualified personnel that represent the diverse world we live in.
+Added: As of June 30, 2025, we had approximately 10,600 employees, of which approximately 4,240 were employed in cost of sales activities including areas such as warehousing and manufacturing, 1,990 in research and development and 4,370 in sales, marketing and administration.
+Added: Of our employees, approximately 3,250 (31%) were located in the U.S., Canada and Latin America, 3,250 (31%) in Asia, 1,570 (14%) in Australia and 2,530 (24%) in Europe.
+Added: We believe that the success of our business will depend, in part, on our ability to attract and retain qualified personnel that represent the world we live in, in every way.
Resmed’s average global turnover rate for fiscal year 2025 was approximately 12%.
−Removed: Diversity and Inclusion
−Removed: Our values of belonging, inclusion and diversity for success (“BIDS”) are woven into the way we work and design our products and help us transform healthcare and improve lives globally.
−Removed: Our BIDS team strives to impact and develop solutions, campaigns, and programs for our people, patients, and products to drive our overall success.
−Removed: Our objectives this year included leveraging our global community of Employee Resource Groups (“ERGs”) to help with product design and people development, creating and delivering development opportunities, identifying new and different sourcing practices and measurements, emphasizing accessibility and disability inclusion, maintaining community partnerships that encourage STEM and the advancement of medical technology, and promoting brand awareness.
+Added: Our Community
+Added: We are committed to the success of our employees and our patients.
+Added: This commitment is integral to how we collaborate and communicate, in the policies we establish, and in our product design.
+Added: Our dedication drives transformation in our patients' healthcare, improving lives globally.
+Added: Our social sustainability team focuses on people practices, developing solutions and programs that enhance our business and brand success.
+Added: Our objectives during this year focused on product design and raising awareness through discussions on accessibility design for our products.
+Added: We also expanded global mentorship opportunities and offered quarterly micro-learnings on many topics.
+Added: Additionally, our team broadened its outreach efforts, collaborating with employee resource groups, or ERGs, and global site leaders to create a global giving program supporting science, technology, engineering, and mathematics, or STEM, health, and sleep awareness initiatives.
Employee Resource Groups.
−Removed: We continue to place a high value on inclusion-building initiatives that create opportunities around cultural awareness and professional development.
−Removed: We are proud of our global, employee-driven ERG network that engages over 6,000 people with weekly learning opportunities.
−Removed: These groups include African and African-American, Asia-American-Pacific Islander, LGBTQIA+, Hispanic and Latin, Veterans, Women in San Diego, Women in Sales, Women in SaaS, Women in Canada, Women in Tech Sydney, Parents, Caregivers, All Abilities, Australian Indigenous, and groups in Malaysia, Singapore, Ireland, Germany and France that collectively focus on local and culturally appropriate inclusion-building needs.
−Removed: Learning and Development of Diversity and Inclusion Values.
−Removed: Our leaders across the organization work directly with our Head of Diversity and Inclusion to identify and provide relevant trainings for their teams to create an inclusive workplace while complying with anti-discrimination laws.
−Removed: We maintained our BIDS Certificate program, which focuses on inclusive leadership and psychological safety.
−Removed: We also launched a digital coaching application for employees worldwide that provides leadership coaching in over 150 scenarios.
−Removed: In addition, we launched a global mentorship and leadership program for women across the Company, ElevateHER, which has cohorts around the world and is focused on building confidence and encouraging strategic thinking.
−Removed: The team also delivered trainings on allyship, the value of diversity on teams, inclusive leadership and disability etiquette.
+Added: We continue to place a high value on initiatives that create community, learning and volunteer opportunities for our employees.
+Added: Our global network comprises nineteen employee-driven ERGs that are instrumental in advancing the success of our patients and employees.
+Added: On average, we host one event per week, accessible to all employees on a purely voluntary basis to encourage learning and community involvement.
+Added: Learning and Development of Inclusion Values.
+Added: Our leaders across the organization work directly with our People team to improve team dynamics and collaboration.
+Added: We offer various resources for leaders to leverage in their workshops and sessions.
+Added: Over the past year, we sustained and expanded the reach of our global mentorship initiatives and launched a reverse mentorship program fostering intergenerational learning with work and technology.
+Added: We also delivered enterprise-wide trainings and quarterly learning sessions.
Strategic Inclusive Development.
−Removed: A Global Council of employees meets every two months to review and provide feedback on BIDS developments and programs, as well as sharing feedback on ongoing diversity and inclusion efforts.
−Removed: Further, our Employee Handbook has been updated to formalize certain inclusivity initiatives.
−Removed: Additionally, we have assessed the language within the source code of our products and platforms to ensure that it does not act to discriminate, is inclusive and does not perpetuate racist stereotypes.
−Removed: We are also actively defining and streamlining language for product testing, trials and patient outreach.
+Added: Every year, employees apply or are nominated by their leaders to sit on our global council that advises on, and promotes, our inclusion efforts.
+Added: The council aims to share developments and gather feedback from representatives across a wide representation of functions and office locations.
+Added: We are also actively defining and streamlining internal language and partnerships in product design, medical research, mask testing, social media, and patient outreach to ensure accessibility and inclusivity are prioritized.
+Added: Leadership Engagement.
+Added: E ach ERG is supported by one to two Executives that serve as a network of champions and help kick off events, attend, advertise, and share learnings with their wider teams.
+Added: They meet collectively every quarter to share impressions, give feedback, and provide ideas on the goal of developing our people.
PART I Item 1
AND SUBSIDIARIES
−Removed: Leadership Engagement.
−Removed: C-Suite Executives, alongside the CEO, receive quarterly updates on diversity data and inclusion-building efforts.
−Removed: Additionally, each ERG is supported by at least one executive sponsor, creating a vast network of champions that help promote and sponsor BIDS, ERG initiatives and the overall success of our business.
+Added: Community Outreach & Giving Back.
+Added: This year, we expanded our community support efforts by designing a giving program to better track and report our efforts, ensuring we provide meaningful support to the communities surrounding our offices.
Sourcing and Recruiting.
−Removed: We train our recruiting workforce on the value of hiring diverse teams and diversity sourcing strategies, and we partner with external organizations that develop and supply diverse talent.
−Removed: We work closely with business partners across the organization and recruiters on sourcing ideation and outreach initiatives that align with our values.
−Removed: In addition, we are continually improving our diversity dashboard to better understand our metrics around applicants, candidates, and the current workforce.
+Added: We train our recruiting workforce on the importance of building a talent pipeline that fosters creativity and ingenuity by leveraging various skill sets.
+Added: Our outreach efforts included community partnerships with various organizations and schools focused on STEM, encouraging careers in these fields and at Resmed.
+Added: In addition, we are continually improving our talent dashboard to better understand our metrics around applicants, candidates and the current workforce.
We comply with global laws preventing discrimination in hiring practices.
1 unchanged sentence
Talent Development and Retention
−Removed: Building and strengthening our talent pipeline is imperative to our success.
−Removed: Our approach to talent and performance is designed to ensure employees and managers have regular feedback conversations about performance goals and development, to enable our high-performance culture, and to create an environment where we achieve our strategy.
−Removed: At ResMed, we have specific career and development pathways designed for specific roles in consultation with operational management, human resources, and learning and development specialists.
−Removed: We provide online courses that are role-specific, with formal tracking of employee completion and performance.
−Removed: Online and face-to-face courses on operational compliance issues are developed and delivered in-house.
−Removed: Online compliance courses on ResMed’s Code of Business Conduct and Ethics, diversity and inclusion, compliance with laws against discrimination, US Foreign Corrupt Practices Act, and health & safety are developed by our Learning and Development team with external subject-matter advisers.
+Added: At Resmed, developing our people is central to achieving our strategic ambitions and delivering on our purpose.
+Added: We believe that building and strengthening our talent pipeline is essential to sustaining a high-performance culture—one where individuals thrive, and teams drive results.
+Added: Our approach to talent and performance is anchored in continuous feedback.
+Added: Regular conversations between managers and team members ensure alignment on performance goals, professional development, and career aspirations.
+Added: These ongoing dialogues are intended to support individual development while reinforcing a shared commitment to excellence.
+Added: We support career growth through specific technical and management career pathways.
+Added: These pathways are developed in collaboration with operational leaders, human resource partners, and learning specialists to ensure relevance and impact.
+Added: Employees are empowered to take charge of their own development through curated online learning journeys tailored to their roles, with formal tracking to monitor progress and outcomes.
+Added: In addition, we have both online and face-to-face training on critical topics such as operational compliance, health and safety, and our Code of Business Conduct and Ethics.
+Added: Topics also include compliance with laws against discrimination and international compliance standards like the U.S.
+Added: Foreign Corrupt Practices Act.
Compensation and Benefits
−Removed: Our compensation philosophy is to reinforce and align with our mission, business strategy, and financial needs as we grow.
−Removed: We provide market-competitive compensation and benefits based on benchmarking surveys we conduct regularly for all position levels against relevant peer companies.
−Removed: Our annual and long-term incentive packages are linked directly to business and individual performance, with a balance of short- and long-term financial and strategic objectives.
−Removed: We have an employee stock purchase plan, in addition to formal service awards internally.
−Removed: Eligibility for non-salary benefits such as salary continuance, life insurance, health insurance, and similar benefits, follows local regulations and practices.
−Removed: Equal opportunity and pay equity are integral to our pay philosophy, and we have processes in place to identify and address any potential pay equity issues where appropriate.
+Added: Our rewards philosophy reinforces and aligns with our mission, business strategy, and financial needs as we grow.
+Added: We provide market-competitive compensation and benefits informed by external benchmarks as well as employee feedback.
+Added: We execute our philosophy based on performance principles of fairness and consistency.
+Added: Our annual and long-term incentives are linked directly to business performance and outcomes, as well as shareholder value creation.
+Added: We offer an employee stock purchase plan globally, as well as recognition rewards catered to localized market practices.
+Added: Eligibility for non-salary benefits such as salary continuance, life insurance, retirement, health insurance, and other benefits, are also aligned to local regulations and practices.
Employee Health and Safety
−Removed: We believe maintaining a physically safe and mentally healthy working environment is essential in supporting our people to deliver their best work.
+Added: We believe that maintaining a physically safe, and mentally healthy, working environment is essential in supporting our people to deliver their best work.
We employ global standards to provide the framework for our locally compliant, integrated and effective health and safety management systems which enable the capability, autonomy & accountability of the leaders to manage local sites.
−Removed: Our approach is to place health & safety as a positive contributor to innovation, continuous improvement and business sustainability through focusing on making work easier, which in turn makes work safer and more efficient.
+Added: This year, we enhanced our resources dedicated to mental health and psychological safety in the workplace.
+Added: Our approach is to prioritize health and safety as a positive contributor to innovation, continuous improvement and business sustainability through focusing on making work easier, which in turn makes work safer and more efficient.
Employee Engagement and Wellbeing
−Removed: We regularly seek employee feedback and sentiment about our workplace through global engagement surveys that enable our people to comment on matters related to their employment experience.
−Removed: We openly share the survey results throughout the company and encourage teams to put in place action plans at global and local levels to address priority issues.
+Added: We regularly seek employee feedback and sentiment about our workplace through annual global engagement surveys that enable our people to rate and comment on matters related to their employment experience.
+Added: We openly share the survey results throughout the company and encourage leaders to put in place action plans at global and local levels to address priority issues.
Where benchmarks are available, our results are evaluated against comparable peer groups.
We are committed to improving the quality of life of our employees and their families.
−Removed: Our health and wellbeing programs differ by country and may include company-sponsored health insurance, retirement savings plans, sleep apnea screening and treatment, smoking cessation, gym membership discounts, seasonal flu vaccinations, mental health assistance, and many other programs to drive healthy behaviors and awareness.
+Added: Our health and wellbeing programs differ by country and may include company-sponsored health insurance, retirement savings plans, sleep apnea screening
+Added: PART I Item 1
+Added: AND SUBSIDIARIES
+Added: and treatment, smoking cessation, gym membership discounts, seasonal flu vaccinations, mental health assistance, and many other programs to drive healthy behaviors and awareness.
Additionally, we have implemented a company-wide Resmed Day - taken at the employee's election - for our people to focus on mental, social and physical health.
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.