What changed in this filing

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Item 1. Business

2024-08-09 compared with 2023-08-11 · 206 added, 181 removed, 513 unchanged (43% of the section changed)

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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.

Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice.

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.

By enabling better care, our products improve quality of life, reduce the impact of chronic disease, and lower costs for consumers and healthcare systems.

Following our formation in 1989, we commercialized a treatment for obstructive sleep apnea, or OSA.

This treatment, continuous positive airway pressure, or CPAP, was the first successful noninvasive treatment for OSA.

Following our formation in 1989, we commercialized a continuous positive airway pressure, or CPAP, treatment for obstructive sleep apnea, or OSA, which was the first successful non-invasive treatment for OSA.

CPAP systems deliver pressurized air, typically through a mask, to prevent collapse of the upper airway during sleep.

Since the development of CPAP, we have expanded our business by developing or acquiring a number of innovative products and solutions for a broad range of respiratory disorders including technologies to be applied in medical and consumer products, ventilation devices, diagnostic products, mask systems for use in the hospital and home, headgear and other accessories, and dental devices.

We offer a comprehensive digital solution suite for patients with COPD or asthma, including those using inhalers, as well as non-invasive or invasive ventilation.

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.

We also provide management software to agencies providing out-of-hospital care, including

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.

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AND SUBSIDIARIES

but not limited to home medical equipment, or HME, home health and hospice, skilled nursing, life plan community, senior living, and private duty services.

We employ over 9,980 people and sell our products in over 140 countries through a combination of wholly owned subsidiaries and independent distributors.

Our website address is www.resmed.com.

Information contained on our website is not part of or incorporated into this report.

We make our periodic reports, together with any amendments, available on our website, free of charge, as soon as reasonably practicable after we electronically file or furnish the reports with the Securities and Exchange Commission, or SEC.

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.

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.

We also make available on our investor relations website, public financial information for which a report is not required to be filed with or furnished to the SEC.

Information contained on our website or in reports, other than those filed with or furnished to the SEC, is not part of or incorporated into this report.

Corporate History

Our Australian subsidiary, ResMed Holdings Limited, was originally organized in 1989 by Dr.

Our Australian subsidiary, ResMed Holdings Pty Limited, was originally organized in 1989 by Dr.

Peter Farrell to acquire from Baxter Center for Medical Research Pty Limited, or Baxter, the rights to certain technology relating to CPAP treatment as well as Baxter’s existing CPAP device business.

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Ten CDIs on the ASX represent one share of our common stock on the NYSE.

Since formation we have acquired a number of businesses, including distributors, suppliers, developers of medical equipment and related technologies, and software solution providers.

For example, in the United States our sleep and respiratory care products are sold by ResMed Corp.

and our software is sold principally by our Brightree and MatrixCare subsidiaries.

Since formation, we have grown organically through global expansion as well as by acquiring a number of businesses, including distributors, suppliers, developers of medical equipment and related technologies, and software solution providers.

Segment Information

We operate in two segments, which are the Sleep and Respiratory Care segment and the Software as a Service, or SaaS, segment.

See Note 13 – Segment Information of the Notes to Financial Statements (Part II, Item 8) for financial information regarding segment reporting.

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.

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.

Additionally, our software solutions are focused on out-of-hospital care, which we believe is fragmented and underserved, and where we see significant opportunity to transform and significantly improve out-of-hospital healthcare through a strategy of enabling better patient care, improving clinical decision support, and driving interoperability across out-of-hospital care settings.

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.

Sleep and Respiratory Care

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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.

While sleep apnea has been diagnosed in a broad cross-section of the population, until recently, it has typically been diagnosed among middle-aged men who are obese.

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.

However, we believe the importance of sleep apnea in women is increasingly being recognized, with nearly 40% of new PAP patients being female.

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A study presented at the European Respiratory Society (ERS) International Congress in 2021 and later published in CHEST in 2022 found that using PAP therapy as directed can significantly increase sleep apnea patients’ chances of living longer.

The study concluded that people with obstructive sleep apnea who continued PAP therapy were 39% more likely to survive over a three-year period than OSA patients who did not.

The study concluded that people with obstructive sleep apnea who started and continued PAP therapy were 39% more likely to survive over a three-year period than OSA patients who did not.

Researchers found that the survival rate gap remained significant when accounting for patients’ ages, overall health, other pre-existing conditions, and causes of death.

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Several studies demonstrate that the oxygen desaturation, increased heart rate and elevated blood pressure caused by OSA may be associated with increased risk of cardiovascular morbidity and mortality due to angina, stroke, and heart attack.

Patients with OSA have been shown to have impaired daytime performance in a variety of cognitive functions including problem- solving, response speed, and visual motor coordination, and studies have linked OSA to increased occurrences of traffic and workplace accidents.

Patients with OSA have been shown to have impaired daytime performance in a variety of cognitive functions including problem- solving, response speed, and visual motor coordination;

studies have linked OSA to increased occurrences of traffic and workplace accidents.

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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During overnight testing, respiratory parameters and sleep patterns may be monitored, along with other vital signs such as heart rate and blood oxygen levels.

Simpler tests, using devices such as our ApneaLink Air, NightOwl, or our automatic positive airway pressure devices, monitor airflow during sleep, and use computer programs to analyze airflow patterns.

These tests allow sleep clinicians to detect any sleep disturbances such as apneas, hypopneas, or subconscious awakenings.

Simpler tests, using devices such as our ApneaLink Air, NightOwl, or our automatic PAP devices, monitor airflow during sleep, and use computer programs to analyze airflow patterns.

These tests allow sleep clinicians to detect sleep disturbances such as apneas, hypopneas, or subconscious awakenings.

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These combined procedures, performed by highly specialized surgeons, are expensive and involve prolonged and often painful recovery periods.

Surgical treatments are not considered first-line therapy for OSA.

Consequently, surgical treatments are not considered first-line therapy for OSA.

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.

Alternative pharmaceutical therapy treatments are reported to be under development.

Alternative pharmaceutical therapy treatments expected to be indicated for OSA treatment are under development.

A variety of devices are marketed for the treatment of OSA.

Most are only partially effective, but CPAP is a reliable treatment for all severities of OSA and is considered first-line therapy.

Most are only partially effective.

CPAP is a reliable treatment for all severities of OSA and is considered first-line therapy.

Use of mandibular advancement devices is increasingly used as a second-line option in patients unable to use CPAP or those with mild OSA.

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Patients experienced soreness from the repeated use of nasal masks and had difficulty falling asleep with the CPAP device operating at the prescribed pressure.

In recent years, product innovations to improve patient comfort and compliance have been developed.

In recent years, we have developed product innovations to improve patient comfort and compliance.

These include more comfortable patient interface systems;

delay timers that gradually increase air pressure allowing the patient to fall asleep more easily;

bilevel air devices, including our AirCurve 10 Series and Lumis devices, which provide different air pressures for inhalation and exhalation;

bilevel air devices, including our AirCurve 11 Series devices, which provide different air pressures for inhalation and exhalation;

heated humidification systems to make the airflow more comfortable;

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Respiratory Care

Our aim is to provide respiratory care solutions to patients with COPD, asthma, and other chronic respiratory diseases, such as overlap syndrome, obesity hypoventilation syndrome, or OHS, and neuromuscular disease, including amyotrophic lateral sclerosis, or ALS.

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.

We aim to improve patient quality of life, slow down disease progression and reduce the costs of patient management.

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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.

We also provide data management systems designed to improve the management of patients.

We also provide data management systems designed to improve the management of patients by care providers.

Chronic Obstructive Pulmonary Disease.

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Patients with COPD can have different clinical presentations.

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 are commonly overweight.

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.

Patients with emphysema have more normal blood gases, are usually thin and hyperinflated

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AND SUBSIDIARIES

the more hypoxic a COPD patient is during the day the more severe the hypoxemia experienced during sleep.

and have a decreased diffusion capacity.

During sleep, chronic bronchitic patients display more severe hypoxemia.

In general, the more hypoxic a COPD patient is during the day the more severe the hypoxemia experienced during sleep.

Hypercapnia as a consequence of hypoventilation also occurs in COPD patients and is more pronounced in REM sleep.

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An estimated 90% of patients with OHS also have OSA.

In patients with OHS, positive airway therapy, both CPAP and NIV, has been shown to effectively treat upper airway obstruction and reverse daytime respiratory failure as well as reduce the work of breathing and improve respiratory drive.

In patients with OHS, positive airway therapy, with either CPAP or NIV, has been shown to effectively treat upper airway obstruction and reverse daytime respiratory failure as well as reduce the work of breathing and improve respiratory drive.

Neuromuscular Disease.

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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.

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 out-of-hospital care settings.

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.

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improved understanding of the role of sleep apnea treatment in the management of cardiac, neurologic, metabolic, and related disorders;

improved understanding of the role of non-invasive ventilation in the management of COPD;

and an increase in the use of digital and product technology to improve patient

improved understanding of the role of non-invasive

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outcomes and create efficiencies for customers and providers.

Our strategy for expanding our business operations and capitalizing on the growth of the sleep apnea and respiratory care, as well as growth in out-of-hospital care settings, consists of the following key elements:

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.

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:

• Continue Product Development and Innovation in Sleep Apnea and Respiratory Care Products.

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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.

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, including AirView, to promote greater patient adherence to therapy.

Our acquisitions have included adding a portfolio of sleep apnea products such as through our acquisition of Curative Medical in 2015.

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.

Our acquisitions have also included adding a portfolio of sleep apnea products such as through our acquisition of Curative Medical in 2015.

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.

We also acquired a digital health platform for inhalers through our acquisition of Propeller Health in 2019, rounding out our portfolio to treat COPD patients through their therapy journey across different stages of their disease.

• Broaden our Digital Health Technology Foundation.

Digital enablement is central to our strategy.

Our 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.

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.

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.

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.

We believe that the combination of continued product development, product and technology acquisitions and innovation are key factors to our ongoing success.

Sleep is becoming a more important aspect of our customers' lives.

We believe increased adoption of wearables with sleep monitoring functionality will drive more sleep-concerned consumers into care pathways.

We believe that the combination of continued product development, product and technology acquisitions and innovation are key factors of our ongoing success.

Approximately 19% of our employees are devoted to research and development activities.

• Expand SaaS Solutions in Out-of-Hospital Care Settings.

Our vision is to transform and significantly improve out-of-hospital (OOH) healthcare through a strategy of enabling better patient care, improving clinical decision support, and driving interoperability across out-of-hospital healthcare settings.

Since acquiring Brightree in 2016, plus MatrixCare and HEALTHCAREfirst in 2018, we offer software solutions across multiple out-of-hospital healthcare settings including HME, home health and hospice, skilled nursing, life plan communities, senior living, and private duty.

Our acquisition of MEDIFOX DAN in 2022, expanded ResMed’s SaaS business outside of the U.S.

to Germany, and added new out-of-hospital care sectors to the business’ ecosystem, including outpatient therapy.

We are connecting capabilities across the platforms in these out-of-hospital care settings to help our customers be more efficient, better serve people, keep them out-of-hospital, and in lower-cost, higher-quality care settings.

Today, our SaaS solutions serve out of hospital providers combining over 139 million individual patient accounts.

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.

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.

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.

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.

Today, our SaaS solutions support out of hospital providers serving over 150 million individual patient accounts.

• Expand Geographic Presence.

We offer our products in more than 140 countries to sleep clinics, home healthcare dealers, patients and third-party payors.

We intend to increase our sales and marketing efforts in our principal geographies, as well as expand the depth of our presence in other high-growth geographic regions.

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.

In 2015, we acquired Curative Medical to invest in China and expand our growth potential in sleep apnea, COPD and respiratory care there.

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.

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 millions of South Korean patients living with sleep apnea, COPD, and other chronic respiratory diseases.

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.

• Increase Public and Clinical Awareness.

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We have helped establish a center for clinical care and medical research at the University of California, San Diego, in the fields of sleep apnea and COPD.

We have also established a chair for the study of sleep medicine at Harvard Medical School.

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.

• Expand into New Clinical Applications.

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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.

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 sleep apnea and the use of non-invasive ventilation, and in-home life-support ventilation to treat COPD and other chronic respiratory diseases.

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.

Our portfolio of products includes devices, diagnostic products, mask systems, headgear and other accessories, dental devices, and cloud-based software and informatics solutions.

For purposes of the following discussion, we refer to our air flow generators and ventilators collectively as devices.

For purposes of the following discussion, we generally refer to our air flow generators and ventilators collectively as devices.

We produce cloud-connected CPAP, automatic positive airway pressure, or APAP, bilevel, adaptive servo-ventilation, or ASV, and HFT devices that deliver positive airway pressure through a patient interface, either a mask or cannula.

Our APAP, devices, known as AutoSet, are based on a patented technology to monitor breathing and can also be used in the diagnosis, treatment and management of OSA in some countries.

During fiscal year 2017, we launched AirMini, a small portable CPAP combining the same proven therapy modes used in the AirSense 10 with waterless humidification enabling portable convenience.

During fiscal year 2017, we launched AirMini, a small portable CPAP combining the same proven therapy modes used in our APAP devices with waterless humidification enabling portable convenience.

During fiscal year 2021, we launched our new platform of connected CPAP and APAP devices, AirSense 11, which introduced new features such as a touch screen, algorithms for patients new to therapy, and digital enhancements, such as over-the-air update capabilities.

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AND SUBSIDIARIES

The tables below provide a selection of devices, as known by our trademarks.

The tables below provide an illustrative selection of devices, as known by our trademarks.

CPAP, APAP & BILEVEL

PRODUCTS DESCRIPTION

Combining enhanced digital health technology with effective therapy modes, AirSense™ 11 APAP and CPAP machines are designed to make starting sleep apnea therapy, and adhering to it, easier and more convenient than ever before.

Our newest device, AirSense 11 includes new features like Personal Therapy Assistant and Care Check-In designed to provide tailored guidance to PAP users, helping ease them into therapy and comfortable nightly use.

AirSense Platform

– AirSense 11 AutoSet

– AirSense 11 AutoSet for Her

– AirSense 11 CPAP

– AirSense 11 Elite

– AirSense 10 AutoSet

– AirSense 10 CPAP

– AirSense 10 Elite

Our newest device, AirSense 11 includes new features like myAir™ Personal Therapy Assistant and Care Check-In designed to provide tailored guidance to PAP users, helping ease them into therapy and comfortable nightly use.

Other features include the availability of remote software updates so users can enjoy the latest version of these tools every night.

– AutoSet for Her

AirSense™ 10 is one of the world’s most widely used series of CPAP and APAP machines, each designed to deliver high-quality therapy for a better night’s sleep.

Features include a built-in humidifier, Climate Control Auto setting to provide breathing comfort, AutoRamp™ with sleep onset detection, and expiratory pressure relief (EPR™).

AirCurve 10 Bilevel

– AirCurve 10 S

The prior generation of these devices, called AirSense™ 10, is the most widely used series of CPAP and APAP machines, each designed to deliver high-quality therapy for a better night’s sleep.

All AirSense machines include a built-in humidifier, Climate Control Auto setting to provide breathing comfort, AutoRamp™ with sleep onset detection and can be used with myAir™, an online support program and app that helps users track their therapy.

AirCurve Bilevel Platform

– AirCurve 11 VAuto

– AirCurve 11 ASV

AirCurve™ 10 bilevel machines include two pressure level settings:

a higher pressure when you inhale, and a lower pressure that makes it easier to exhale.

AirCurve 10 S and AirCurve 10 VAuto both treat obstructive sleep apnea, while AirCurve 10 ASV treats central sleep apnea.

All machines include a built-in humidifier and Climate Control Auto setting to provide breathing comfort.

– AirCurve 10 VAuto

– AirCurve 10 ASV

– AirCurve 10 S

Bilevel machines include two pressure level settings:

a higher pressure when a patient inhales, and a lower pressure that makes it easier to exhale.

AirCurve™ devices are for therapy users who benefit from greater pressure support.

AirCurve™ 11 VAuto and AirCurve™ 10 VAuto treat patients with OSA and non-compliant OSA.

AirCurve™ 11 ASV and AirCurve™ 10 ASV treat patients with CSA, OSA, mixed apneas or periodic breathing.

AirCurve 11 includes myAir™, Care Check-In and Personal Therapy Assistant, digital health solutions designed to help users start therapy and stay on track.

All AirCurve machines include a built-in humidifier, Climate Control Auto setting to provide breathing comfort and myAir™, an online support program and app that helps users track their therapy.

AirMini portable CPAP The smallest portable CPAP on the market today, AirMini features the same auto-adjusting therapy modes used in the AirSense™ 10 Auto.

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PRODUCTS DESCRIPTION

Stellar 150 ResMed Stellar™ 150 ventilator is suitable for invasive and non-invasive ventilation, either at home or in a healthcare setting.

It is not a life support ventilator.

Stellar 150 also includes iVAPS™ (intelligent Volume-Assured Pressure Support) 1 technology to adjust to your changing respiratory needs.

Astral 100 and 150 ResMed Astral™ 100 and Astral 150 provide personalized care every step of the way.

Stellar 100 and 150 ResMed Stellar™ 100 and 150 ventilators are suitable for invasive and non-invasive ventilation, either at home or in a healthcare setting.

They are not a life support ventilator.

Stellar 150 also includes iVAPS™ (intelligent Volume-Assured Pressure Support) technology to adjust to changing respiratory needs.

Astral 100 and 150 ResMed Astral™ 100 and 150 are life support devices that provide personalized care every step of the way.

With both invasive and non-invasive options, they offer a lightweight design, exceptional battery life and adaptive technologies to provide greater mobility and peace of mind.

AirCurve 10 ST-A Designed for people with respiratory conditions that affect breathing such as restrictive lung disorders, severe COPD and hypoventilation, AirCurve™ 10 ST-A combines user-friendly controls, an intuitive interface and automatic features to make ventilation therapy effective, comfortable and hassle-free.

AirCurve 10 ST-A ResMed AirCurve™ 10 ST-A is designed for people with respiratory conditions that affect breathing such as restrictive lung disorders, severe COPD and hypoventilation.

It combines user-friendly controls, an intuitive interface and automatic features to make ventilation therapy effective, comfortable and hassle-free.

Lumis VPAP S, ST and ST-A ResMed Lumis™ series ventilators are designed to provide personalized ventilation support for people with respiratory insufficiency or OSA and are suitable for non-invasive ventilation, either at home or in a healthcare setting.

They are not a life support ventilator.

The Lumis™ 150 VPAP ST and ST-A feature iVAPS™ technology to adjust to changing respiratory needs.

Mask Systems, Diagnostic Products, Accessories and Other Products

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CATEGORY DESCRIPTION

Minimalist AirFit F30, AirFit P10, and AirFit N30 minimalist masks feature our lightest, lowest profile designs.

Minimalist AirFit F40, AirFit F30, AirFit P10, and AirFit N30 minimalist masks feature our lightest, lowest profile designs.

The features of these masks are focused on minimizing contact with the patient’s face to reduce red marks and irritation.

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It works with AirView Diagnostics to provide comprehensive diagnostic solution to clinicians.

NightOwl A portable, cloud-connected, fully disposable diagnostic device that measures AHI based on peripheral arterial tone, actigraphy, and oximetry over several nights.

NightOwl A portable, cloud-connected, fully disposable diagnostic device that measures AHI based on derived peripheral arterial tone, actigraphy, and oximetry over several nights.

Connected Solutions and Other Products

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AirView A cloud-based system enabling remote monitoring and changing of patients’ device settings.

AirView also makes it easier to simplify workflows and collaborate more efficiently across the patient’s care network.

AirView also makes it easier to simplify workflows and collaborate more efficiently across patient care networks.

myAir A personalized therapy management application for patients with sleep apnea providing support, education and troubleshooting tools for increased patient engagement and improved compliance.

U-Sleep A compliance monitoring solution that enables HMEs to streamline their sleep programs to achieve better business and patient outcomes.

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.

Propeller Propeller's inhaler sensors track medication usage and pair with a companion smartphone application, giving people with asthma or COPD a better understanding of their disease and promoting increased adherence to treatment.

The Propeller Provider Portal gives clinicians timely and accurate information they need to make better treatment decisions.

SaaS Products

Following multiple acquisitions, including Brightree in 2016, HEALTHCARE first and MatrixCare in 2018, and MEDIFOX DAN in November 2022, we now provide out-of-hospital software products designed to support the professionals and caregivers helping people stay healthy in the home or care setting of their choice.

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.

SaaS revenue accounted for approximately 12%, 12%, and 11% of our net revenue in fiscal years 2024, 2023, and 2022, respectively.

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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.

HEALTHCAREfirst

HEALTHCAREfirst solutions

HEALTHCAREfirst offers electronic health record, or EHR, software, billing and coding services, and advanced analytics that enable home health and hospice agencies to optimize their clinical, financial and administrative processes.

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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.

Across the sleep and respiratory care platforms, we support clinical trials in many countries including the United States, Germany, Netherlands, France, Japan, the United Kingdom, Switzerland, China, Spain, Canada, Singapore, and Australia to develop new clinical applications for our technology.

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.

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.

Some of the more recent real-world studies point to a link between PAP adherence and lower health care resource utilization.

Some of the more recent real-world studies point to a link between PAP adherence and lower healthcare resource utilization.

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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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.

Our SaaS solutions are sold to providers of healthcare in various out-of-hospital settings.

Our SaaS solutions are sold to providers of healthcare in various OOH settings.

We market and sell our Brightree business management software and service solutions to providers in the United States.

Our primary markets are HME, pharmacy, home infusion, orthotics and prosthetics.

Our sales activities for Brightree products are conducted through a sales organization made up of strategic account managers, sales engineers and sales directors.

Our sales activities for Brightree products are conducted through an employee sales organization made up of strategic account managers, sales engineers and sales directors.

We develop, market, and sell our MatrixCare care management and related ancillary solutions to providers in the U.S.

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We use a combination of our direct sales force and independent distributors to sell our products in combined Europe, Asia, and other regions.

We select independent distributors in each country based on their knowledge of respiratory medicine and a commitment to sleep apnea therapy.

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.

In countries where we sell our products direct, a local senior manager is responsible for direct national sales.

In many countries, we sell our products to home healthcare dealers or hospitals who then sell the products to the patients.

In Germany, Australia, New Zealand, and South Korea, we also operate home healthcare businesses, providing products and services directly to patients.

In Germany, Australia, New

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Zealand, and South Korea, we also operate home healthcare businesses, providing products and services directly to patients through a vertically integrated network.

We only sell our SaaS products in the United States and Germany.

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We operate a globally distributed manufacturing network designed to optimize quality, control costs, reduce time to market for new product introduction, and generate supply chain resilience.

Our manufacturing operations consist of specialist component production as well as technical assembly and testing of our devices, masks, and accessories.

Our manufacturing operations consist of specialist component production as well as technical assembly and comprehensive testing and quality control of our devices, masks, and accessories.

Of the numerous raw materials, parts and components purchased for our therapeutic and diagnostic sleep disorder products, many are available from multiple vendors.

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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.

The most disruptive effects of the COVID-19 pandemic are largely behind us.

We continue to be impacted, however, by supply constraints on certain raw materials and electronic components, including semiconductor chips.

These constraints have impacted and may continue to impact our ability to manufacture products in quantities necessary to satisfy customer demand, which could negatively impact our results of operations.

We are actively working to mitigate the impact of supply constraints by multi-sourcing and qualifying alternate materials.

Our quality management system is based upon the requirements of ISO 9001, ISO 13485, FDA 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.

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.

We continue to be impacted by periodic transport disruptions and supply constraints on certain raw materials and electronic components, including semiconductor chips.

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.

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.

Our main manufacturing sites are certified to ISO 13485 and are audited at regular intervals by a Notified Body.

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Domestic third-party payors include government payors such as Medicare and Medicaid and commercial health insurance plans.

These payors may deny coverage and reimbursement if they determine that a device is not used in accordance with certain covered treatment methods, or is experimental, or not deemed reasonable and necessary.

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.

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.

In some foreign markets, 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 foreign countries, there is currently limited or no reimbursement for devices that treat OSA.

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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.

Healthcare reform in the United States 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).

In 2011, the Centers for Medicare & Medicaid Services, or CMS, implemented the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) competitive bidding program, which included DME that we manufacture and develop, specifically, CPAP and respiratory assist devices (or bilevel devices), and related supplies and accessories.

In 2011, the Centers for Medicare & Medicaid Services, or CMS, implemented the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) competitive bidding program, which included durable medical equipment purchasers of our CPAP and respiratory assist devices (or bilevel devices), and related supplies and accessories.

Under the program, DMEPOS suppliers compete to become Medicare contract suppliers by submitting bids to furnish certain items in competitive bidding areas (CBAs).

The lower payment amounts resulting from the competition may replace the Medicare fee schedule amounts for the bid items in these areas.

CMS is required by law to recompete these contracts at least once every three years and to roll out the competitive bidding process nationally or adjust prices in non-competitive bidding areas to match competitive bidding prices.

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CMS then removed 13 product categories, including CPAP and respiratory assist devices (or bilevel devices), from the Round 2021 Competitive Bidding Program competition.

As a result, these products are currently subject to a temporary gap period during which any Medicare-enrolled DMEPOS supplier may furnish DMEPOS items and services to patients.

CMS stated in rulemaking that it will be paying the single payment amounts established during the DMEPOS Competitive Bidding Program updated by an inflation adjustment factor on an annual basis for products furnished in the competitive bidding areas.

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.

In non-competitive bidding and non-rural areas, the Coronavirus Aid, Relief, and Economic Security (CARES) Act mandated that the fee schedule amounts for certain items furnished in rural and non-contiguous non-competitive bidding areas be based on a 50/50 blend of adjusted and unadjusted fee schedule amounts through the duration of the Public Health Emergency (PHE).

Through final rulemaking in December 2021, CMS finalized policy that they will continue paying suppliers the 50/50 blend of adjusted and unadjusted fee schedule rates for furnishing items and services in rural and non-contiguous areas regardless of the PHE.

The CARES Act also required payment in non-competitively bid areas other than rural or non-contiguous areas be based on a 75/25 blend of adjusted and unadjusted fee schedule amounts through the duration of the PHE, which ended on May 11, 2023.

The Consolidated Appropriations Act, 2023, requires that this 75/25 blended payment in non-competitively bid areas other than rural or non-contiguous areas continue beyond the end of PHE, through December 31, 2023.

Other legislative changes have been proposed and adopted since the ACA was enacted.

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.

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.

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.

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).

Other legislative changes have been proposed and adopted since the Affordable Care Act (ACA) was enacted.

On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, resulted in reductions to Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 but were subject to a temporary suspension.

The Protecting Medicare and American Farmers From Sequester Cuts Act was signed into law December 10, 2021.

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 is extended through the first six months of 2032.

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.

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.

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).

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.

The legislative landscape is complex and changes with the influence of one party or the other.

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Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.

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.

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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

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Our distributors either repair our products with parts supplied by us or arrange shipment of products to our facilities for repair or replacement.

We receive returns of our products from the field

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for various reasons.

We receive returns of our products from the field for various reasons.

We believe that the level of returns experienced to date is consistent with levels typically experienced by manufacturers of similar devices.

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Finally, our products compete with surgical procedures, nerve stimulation devices, and dental appliances designed to treat OSA and other sleep apnea-related respiratory conditions.

The development of new or innovative procedures, devices, or therapies, such as pharmaceuticals, by others could result in our products becoming obsolete or noncompetitive, which would harm our revenues and financial condition.

The adoption of new pharmaceuticals to treat obesity, a typical comorbidity of OSA, could impact our ongoing or future sales.

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.

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.

Many of our customers use systems developed in-house to run their businesses.

The development of new or innovative solutions by others could result in our solutions becoming obsolete or noncompetitive, which would harm our revenues and financial condition.

The development of new or innovative software solutions by others could result in our solutions becoming obsolete or noncompetitive, which would harm our revenues and financial condition.

Any product developed by us will have to compete for market acceptance and sales.

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Accordingly, the speed with which we can develop products and solutions, complete clinical testing and regulatory clearance processes, and provide commercial supply of products and solutions to the market are important competitive factors.

In addition, our ability to compete will continue to be dependent on successfully protecting our patents and other intellectual property.

In addition, our ability to compete will continue to be dependent on successfully protecting our products with patents and other intellectual property.

Patents and Proprietary Rights and Related Litigation

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We believe the combination of these rights, in aggregate, are of material importance to each of our businesses.

Through our various subsidiaries, as of the date of this report, we own or have licensed rights to approximately 9,700 pending, allowed or granted patents and designs.

Through our various subsidiaries, as of the date of this report, we own or have licensed rights to approximately 9,711 pending, allowed or granted patents and designs globally.

Patents and designs have various statutory terms based on the legislation in individual jurisdictions which may be subject to change.

Of our patents, 619 U.S.

patents and 1,472 foreign patents are due to expire in the next five years.

Of our patents, approximately 612 U.S.

patents and approximately 1,507 foreign patents 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.

Litigation has been necessary in the past and may be necessary in the future to enforce patents issued to us, to protect our rights, or to defend third-party claims of infringement by us of the proprietary rights of others.

The defense and prosecution of patent claims, including pending claims, as well as participation in other inter-party proceedings, can be expensive and time-consuming, even in those instances in which the outcome is favorable to us.

Patent laws regarding the enforceability of patents vary from country to country.

We have in the past, and may in the future, be required to license patents and other intellectual property rights owned by other parties.

We have in the past, and may in the future, be required or choose to license patents and other intellectual property rights owned by other parties.

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.

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Government Regulations

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Medical device products are subject to rigorous FDA and other governmental agency regulations in the United States and similar regulations of foreign agencies abroad.

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 such products, in order to ensure that medical products distributed in the United States are safe and effective for their intended use.

In addition, the

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FDA is authorized to establish special controls to provide reasonable assurance of the safety and effectiveness of most devices.

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.

In addition, the FDA is authorized to establish special controls to 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.

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As a medical device manufacturer, all of our manufacturing facilities are subject to inspection on a routine basis by the FDA.

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.

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.

We believe that our design, manufacturing and quality control procedures are in compliance with the FDA’s regulatory requirements.

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

We are required to adhere to

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a death or serious injury.

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.

We believe that our design, manufacturing and quality control procedures are in compliance with the FDA’s regulatory requirements.

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.

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All manufacturers placing medical devices into the market in the EEA must comply with the EU Medical Device Vigilance System.

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.

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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.

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Where appropriate, our products commercialized in Europe are CE marked and classified as either Class I or Class II.

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On April 5, 2017, the European Parliament passed the MDR, which repeals and replaces the MDD.

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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.

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Other Healthcare Laws

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The government has interpreted these laws broadly to apply to the marketing and sales activities of manufacturers and distributors like us.

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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.

In addition, a person or entity does not need to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation.

Due to the breadth of the federal Anti-Kickback Statute, Congress set forth certain exceptions and authorized the Secretary of the Department of Health and Human Services to issue regulations that set forth certain safe harbors to protect arrangements that while implicating the federal Anti-Kickback Statute, would generally not cause harm to federal health care programs or patients.

Satisfaction of all elements of a particular Anti-Kickback Statute statutory exception or regulatory safe harbor will provide immunity from prosecution under the Anti-Kickback Statute to the parties to such remunerative arrangement.

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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.

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Also, many U.S.

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In addition, in the U.S., certain states also mandate implementation of commercial compliance programs, impose restrictions on device manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to healthcare professionals and entities.

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FCPA and Other Anti-Bribery and Anti-Corruption Laws

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corporations and their representatives from offering, promising, authorizing or making payments to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business abroad.

The scope of the FCPA would include interactions with certain healthcare professionals in many countries, either directly or through our contracted distributors.

The scope of the FCPA includes interactions with certain healthcare professionals in many countries, either directly or through our contracted distributors.

Our present and future business has been and will continue to be subject to various other U.S.

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Under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, which we collectively refer to as HIPAA, the Department of Health and Human Services, or HHS, has issued regulations, including the HIPAA Privacy, Security and Breach Notification Rules, to protect the privacy and security of protected health information, or PHI, used or disclosed by covered entities and their business associates, as well as covered subcontractors.

HIPAA also regulates standardization of data content, codes and formats used in health care transactions and standardization of identifiers for health plans and providers.

HIPAA also regulates standardization of data content, codes and formats used in healthcare transactions and standardization of identifiers for health plans and providers.

Penalties for violations of HIPAA regulations include significant civil and criminal penalties for each violation.

In some of our operations, such as those involving our cloud-based software digital health applications, we are a business associate under HIPAA.

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.

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.

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.

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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.

Further, since 2020, approximately ten U.S.

states have adopted—and other states are proposing to adopt— their own comprehensive data protection laws, with varying implementation dates starting January 1, 2023.

Further, since 2020, approximately one-quarter of U.S.

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.

The application of the laws and the requirements contained therein is not uniform.

Although the majority of the state laws exclude business data, we may be required to undertake additional compliance investment and potentially change our business processes to evaluate the application of these laws to our business and to implement compliance measures.

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, at least three 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.

Certain of our products use, or permit the use of, information that could be classified as a biometric under these or other laws.

If we are subject to or affected by these or other laws, we may be required to modify the way in which we make available our product or certain features of our product.

We also may be required to implement additional practices or processes or otherwise invest our resources to comply with these and other regulations.

In some of our operations, such as those involving our cloud-based software digital health applications, we are a business associate under HIPAA and therefore 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, and are subject to significant civil and criminal penalties for failure to do so.

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.

If we are subject to

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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.

Certain of our products use, or permit the use of, information that could be classified as a biometric under these or other laws.

If we are subject to or affected by these or other laws, we may be required to modify the way in which we make available our product or certain features of our products.

We also may be required to implement additional practices or processes or otherwise invest our resources to comply with these and other regulations.

In addition, the European Union General Data Protection Regulation, or GDPR, went into effect in May 2018.

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In addition, Congress and some states are considering new laws and regulations that further protect the privacy and security of medical records or medical information.

All 50 states have passed laws regulating the actions that a business must take if it experiences a data breach, such as prompt disclosure to affected customers.

The Federal Trade Commission, or FTC, and states’ Attorneys General have also brought enforcement actions and prosecuted some data breach cases as unfair and/or deceptive acts or practices under the FTC Act.

All 50 states and the District of Columbia have passed laws regulating the actions that a business must take if it experiences a data breach, such as prompt disclosure to affected customers.

The Federal Trade Commission, or FTC, and states’ Attorneys General have also brought enforcement actions and prosecuted data breach cases as unfair and/or deceptive acts or practices under the FTC Act.

In addition to data breach notification laws, some states have enacted statutes and rules requiring businesses to reasonably protect certain types of personal information they hold or to otherwise comply with certain specified data security requirements for personal information.

These laws may apply directly to our business or indirectly by contract when we provide services to other companies.

The FTC also has focused on the use of online tracking technologies that collect personal information as well as artificial intelligence (AI) and the potential bias in AI as one of its enforcement and policy priorities, including the use of both online tracking tools and AI in the healthcare space.

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.

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.

Our services and products may use AI now or in the future.

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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.

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

At ResMed, our mission of transforming patient care in the out-of-hospital setting through innovative solutions and technology-driven integrated care is achieved by our commitment and efforts in fostering an inclusive environment that creates a strong sense of belonging, which unlocks the potential, passion and creativity of our people.

Our Code of Business Conduct & Ethics, Diversity and Inclusion practice and other practices and policies on workplace behavior,

If we fail to comply with any such laws or regulations, we may face significant fines and penalties that

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discrimination and harassment, health and safety, and employee benefits reinforce this environment and facilitate talent attraction, retention, and development.

could adversely affect our business, financial condition and results of operations, damage our reputation and customers’ trust.

Human Capital

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.

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.

Our board of directors and its committees provide general oversight on a range of our human capital management efforts.

These efforts include general oversight of our environmental, social, governance, and sustainability efforts as addressed below.

As of June 30, 2023, we had approximately 10,140 employees or contingent workers, of which approximately 4,310 were employed in cost of sales activities including areas such as warehousing and manufacturing, 1,750 in research and development and 4,080 in sales, marketing and administration.

This includes environmental, social, and governance efforts addressed below.

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.

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.

We believe that the success of our business will depend, in part, on our ability to attract and retain diverse, qualified personnel.

ResMed’s global turnover rate for fiscal year 2023 was approximately 14%.

Diversity & Inclusion

Our values of belonging, inclusion and diversity for success (“BIDS”) enable us to unlock the strengths of our people to transform healthcare and improve lives.

We are in our third year of having a BIDS team that strives to impact and develop our people, patients, and products.

Our objectives include expanding our community of Employee Resource Groups (“ERGs”) globally, creating and delivering learning and development opportunities, identifying new and different sourcing practices and measurements, emphasizing accessibility and disability inclusion, promoting inclusive leadership behaviors and practices, and exploring new community partnerships.

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.

ResMed’s average global turnover rate for fiscal year 2024 was approximately 18%.

Diversity and Inclusion

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.

Our BIDS team strives to impact and develop solutions, campaigns, and programs for our people, patients, and products to drive our overall success.

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.

Employee Resource Groups.

We continue to place a high value on inclusion-building initiatives that create opportunities around cultural awareness and social learnings.

We maintain our ERGs worldwide and currently have seventeen groups that engage over 1,000 people with weekly learning opportunities:

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 Mosaics in Ireland, Germany and France that collectively focus on local and culturally appropriate inclusion-building needs.

Learning & Development of D&I Values.

Our leaders across the organization work directly with our Head of Diversity and Inclusion to identify and provide relevant trainings for their teams.

This year, the team launched a BIDS Certificate program focusing on inclusive leadership and psychological safety.

The team also delivered many trainings on allyship, the value of diversity on teams, and disability etiquette.

We continue to place a high value on inclusion-building initiatives that create opportunities around cultural awareness and professional development.

We are proud of our global, employee-driven ERG network that engages over 6,000 people with weekly learning opportunities.

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.

Learning and Development of Diversity and Inclusion Values.

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.

We maintained our BIDS Certificate program, which focuses on inclusive leadership and psychological safety.

We also launched a digital coaching application for employees worldwide that provides leadership coaching in over 150 scenarios.

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.

The team also delivered trainings on allyship, the value of diversity on teams, inclusive leadership and disability etiquette.

Strategic Inclusive Development.

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Further, our Employee Handbook has been updated to formalize certain inclusivity initiatives.

Additionally, we have assessed the language within the source code of our products and platforms to ensure that it is inclusive and does not perpetuate racist stereotypes.

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.

We are also actively defining and streamlining language for product testing, trials and patient outreach.

PART I Item 1

AND SUBSIDIARIES

Leadership Engagement.

C-Suite Executives, alongside the COO and CEO, receive quarterly updates on diversity data and inclusion-building efforts.

Additionally, the CEO and senior leaders across the organization have diversity and inclusion objectives embedded in their annual and quarterly goals.

Each ERG/Mosaic is supported by an Executive Sponsor.

Sourcing & Recruiting.

C-Suite Executives, alongside the CEO, receive quarterly updates on diversity data and inclusion-building efforts.

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.

Sourcing and Recruiting.

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.

In addition, we are building a diversity dashboard to better understand our metrics around applicants, candidates, and the current workforce.

In 2022, we launched campaigns focused on collecting internal data and gathering diverse prospective candidates.

Talent Development & Retention

We work closely with business partners across the organization and recruiters on sourcing ideation and outreach initiatives that align with our values.

In addition, we are continually improving our diversity dashboard to better understand our metrics around applicants, candidates, and the current workforce.

We comply with global laws preventing discrimination in hiring practices.

We do not employ the use of quotas or required hiring targets.

Talent Development and Retention

Building and strengthening our talent pipeline is imperative to our success.

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.

PART I Item 1

AND SUBSIDIARIES

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.

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Online and face-to-face courses on operational compliance issues are developed and delivered in-house.

Online compliance courses on ResMed’s Code of Business Conduct and Ethics, diversity and inclusion, US Foreign Corrupt Practices Act, and health & safety are developed by our Learning and Development team with external subject-matter advisers.

Compensation & Benefits

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.

Compensation and Benefits

Our compensation philosophy is to reinforce and align with our mission, business strategy, and financial needs as we grow.

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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.

Employee Health & Safety

Employee Health and Safety

We believe maintaining a physically safe and mentally healthy working environment is essential in supporting our people to deliver their best work.

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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.

Employee Engagement & Wellbeing

Employee Engagement and Wellbeing

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.

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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.

What changed 10-K

Item 1. Business