What changed in this filing

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Item 1. Business

2023-08-11 compared with 2022-08-12 · 233 added, 235 removed, 461 unchanged (50% of the section changed)

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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 software health applications 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

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

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satisfaction with their therapy.

We also provide management software to agencies providing out-of-hospital care, including but not limited to home medical equipment, or HME, home health and hospice, skilled nursing, life plan community, senior living, and private duty services.

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 10,140 people and sell our products in over 140 countries through a combination of wholly owned subsidiaries and independent distributors.

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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.

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.

Segment Information

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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 the sleep and related respiratory care markets, both of which we believe are globally underpenetrated markets, 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 the out-of-hospital care market, 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.

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.

Sleep and Respiratory Care

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rapid eye movement, or REM, sleep and non-rapid eye movement, or non-REM, sleep.

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

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paralysis of many muscles.

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.

Non-REM sleep is subdivided into four stages that generally parallel sleep depth;

stage 1 is the lightest and stage 4 is the deepest.

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The upper airway has no rigid support and is held open by active contraction of upper airway muscles.

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While these awakenings greatly impair the quality of sleep, the individual is not normally aware of these disruptions.

In addition, OSA has been recognized as a cause of hypertension and a significant comorbidity for heart disease, stroke and type 2 diabetes.

OSA has been recognized as a cause of hypertension and a significant comorbidity for heart disease, stroke, and type 2 diabetes.

A long-term epidemiology study published in 2013 estimated that 26% of adults age 30-70 have some form of obstructive sleep apnea.

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It is estimated that less than 20% of those with OSA have been diagnosed or treated.

Many healthcare professionals are often unable to diagnose OSA because they are unaware that such non-specific symptoms as excessive daytime sleepiness, snoring, hypertension, and irritability are characteristic of OSA.

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.

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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 didn’t.

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.

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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OSA is the most common form of SDB.

Sleep fragmentation and the loss of the deeper levels of sleep caused by OSA can lead to excessive daytime sleepiness, reduced cognitive function, including memory loss and lack of concentration, depression and irritability.

Sleep fragmentation and the loss of the deeper levels of sleep caused by OSA can lead to excessive daytime sleepiness, fatigue, reduced cognitive function, including memory loss and lack of concentration, depression, and irritability.

OSA sufferers also experience an increase in heart rate and an elevation of blood pressure during the cycle of apneas.

Several studies indicate 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.

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.

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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

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.

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programs to analyze airflow patterns.

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

Before 1981, the primary treatment for OSA was a tracheotomy, a surgical procedure to create a hole in the patient’s windpipe.

Alternative surgical treatments have involved either uvulopalatopharyngoplasty, or UPPP, in which surgery is performed on the upper airway to remove excess tissue and to streamline the shape of the airway or implanting a device to add support to the soft palate.

Alternative surgical treatments have involved either uvulopalatopharyngoplasty, or UPPP, in which surgery is performed on the upper airway to remove excess tissue and streamline the shape of the airway or implant a device to add support to the soft palate.

UPPP alone has a poor success rate;

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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.

During CPAP treatment, a patient sleeps with a nasal interface connected to a small portable air device that delivers room air at a positive pressure.

During CPAP treatment, a patient sleeps with an interface connected to a small portable air device that delivers room air at a positive pressure.

The patient breathes in air from the device and breathes out through an exhaust port in the interface.

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Sometimes, when a patient leaks air through their mouth, a full-face mask may need to be used, rather than a nasal interface.

CPAP is not a cure and, therefore, must be used on a nightly basis as long as treatment is required.

Patient compliance has been a major factor in the efficacy of CPAP treatment.

CPAP is not a cure and, therefore, must be used nightly as long as treatment is required.

Patient compliance has been a major factor in the effectiveness of CPAP treatment.

Early generations of CPAP units provided limited patient comfort and convenience.

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These include more comfortable patient interface systems;

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

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;

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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.

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

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

Our products cover patients ranging from those who only require therapy from CPAP systems at night to those who are dependent on non-invasive or invasive ventilation for life-support.

Our devices are predominantly used in the home and, to a lesser extent, in general hospital wards and respiratory wards.

We supply CPAP and bilevel device systems, non-invasive and invasive ventilators, humidifiers and accessories, including masks and tubing.

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.

In March 2020, the World Health Organization declared the outbreak of a novel strain of coronavirus, COVID-19, as a pandemic.

We have observed increased demand for our ventilator devices and masks, and during the first six months of the pandemic worked closely with governments, health authorities, hospitals, and physicians in over 100 countries to assess their needs and deliver the ventilation therapy that is essential to treat the respiratory complications of COVID-19.

Although there is still substantial uncertainty associated with the COVID-19 pandemic, we believe the global demand for ventilators and other respiratory support devices used to treat COVID-19 patients has largely been met.

Our primary focus with regards to the pandemic remains preservation of life;

our strategy is to maximize the availability of ResMed ventilators and other respiratory support devices for the patients that need them most.

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Chronic Obstructive Pulmonary Disease.

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COPD includes diseases such as emphysema and chronic bronchitis.

A recent study based on recent epidemiology data estimates that there are over 380 million people worldwide who suffer from COPD, the world’s third leading cause of death.

A recent study based on recent epidemiology data estimates that there are approximately 480 million people worldwide who suffer from COPD, the world’s third leading cause of death.

Patients with COPD can have different clinical presentations.

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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.

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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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Home non-invasive ventilation has the potential to reduce healthcare costs associated with the management of patients with severe COPD by significantly increasing the time between hospital readmissions.

Early research also suggests that home HFT may help improve clinical outcomes in hypoxemic COPD patients that frequently have exacerbations.

Overlap Syndrome.

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Software as a Service

Due to multiple acquisitions, including Brightree in April 2016, HEALTHCAREfirst in July 2018 and MatrixCare in November 2018, our operations now include platforms that comprise our SaaS business.

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 provider

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markets through a growing portfolio of value-added solutions with broad market applicability.

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.

Business Strategy

We believe that the sleep apnea and respiratory care markets will continue to grow in the future due to a number of factors, including increasing awareness of OSA, CSA and COPD, 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 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 markets, as well as growth in out-of-hospital care settings, consists of the following key elements:

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;

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

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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:

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

We are committed to ongoing innovation in developing products for the diagnosis and treatment of sleep apnea.

We have been a leading innovator of products designed to treat sleep apnea more effectively, increase patient comfort and encourage compliance with prescribed therapy.

In recent years we have introduced a full suite of masks in our AirFit and AirTouch ranges as well as advanced and expanded the integrations of our therapy-based software solutions, including AirView, to promote greater patient adherence.

Our recent acquisitions have included a portfolio of sleep apnea products through our acquisition of Curative Medical.

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 the 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 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.

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.

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.

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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.

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 their previous night’s data.

In the United States we have released ResMed MaskSelector, an easy-to-use digital tool to make mask selection and sizing easier and more effective, and HelloSleep, an application to help patients prepare for their fitting and first nights of therapy.

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.

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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 announced acquisition of MEDIFOX DAN in June 2022, pending regulatory clearances, will expand ResMed’s SaaS business outside the U.S.

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

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 OOH customers combining over 115 million individual accounts.

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

• Expand Geographic Presence.

We market 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 markets, as well as expand the depth of our presence in other high-growth geographic regions.

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

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.

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.

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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.

These promotional 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.

These promotional activities target both the population predisposed to sleep apnea and medical specialists, such as pulmonologists, sleep medicine specialists, primary care physicians, cardiologists,

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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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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 a number of prominent physicians to explore new medical applications for our products and technology.

We maintain close working relationships with prominent physicians to explore new medical applications for our products and technology.

• Leverage the Experience of our Management Team.

Our senior management 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.

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.

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

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.

We produce cloud-connected CPAP, APAP, bilevel, and ASV 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 proprietary technology to monitor breathing and can also be used in the diagnosis, treatment and management of OSA.

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

We commenced a controlled product launch of AirSense 11 in fiscal year 2021, which was followed by a broader launch throughout fiscal year 2022.

AirSense 11 introduced new features such as a touch screen, algorithms for patients new to therapy and digital enhancements, such as over-the-air update capabilities.

We also acquired a line of Chinese-developed and manufactured sleep and ventilation devices with the acquisition of Curative Medical in fiscal year 2016.

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 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.

Devices in total accounted for approximately 54%, 52%, and 50% of our net revenues in fiscal years 2023, 2022, and 2021, respectively.

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

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

CPAP, APAP & BILEVEL

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– AutoSet for Her

– Card-to-Cloud

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.

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– AirCurve 10 ASV

– AirCurve 10 VAuto

– Card-to-Cloud

AirCurve™ 10 bilevel machines include two pressure level settings:

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ApneaLink Air A portable diagnostic device that measures oximetry, respiratory effort, pulse, nasal flow and snoring.

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 (PAT), actigraphy, and oximetry over several nights to capture variability and help avoid misdiagnosis.

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.

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.

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.

PRODUCTS DESCRIPTION

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

Connectivity Module A module providing cellular connection between our compatible ventilation devices (e.g., Astral, Stellar) and our AirView™ system.

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 the timely and accurate information they need to make better treatment decisions.

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 April 2016, HEALTHCARE first in July 2018 and MatrixCare in November 2018, we now supply 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 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.

SaaS revenue accounted for approximately 12%, 11%, and 12% of our net revenue in fiscal years 2023, 2022, and 2021, 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.

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.

HEALTHCAREfirst

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.

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.

Product Development and Clinical Trials

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Since then, we have been committed to an ongoing program of product advancement and development.

Currently, our product development and clinical trial efforts are focused on not only improving our current product offerings and usability, but also expanding into new product applications.

Currently, our product development and clinical trial efforts are focused on not only improving our current product offerings and usability, but also expanding into new digital product applications.

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We continually seek to identify new applications of our technology for significant unmet medical needs.

Sleep apnea is associated with a number of symptoms beyond excessive daytime sleepiness and irritability.

Sleep apnea is associated with a number of symptoms beyond excessive daytime sleepiness, fatigue and irritability.

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.

We also continue to support some of the largest sleep apnea studies in history by performing advanced statistical analyses on millions of real-world clinical data points collected through our cloud-connected devices and patient engagement tools.

These studies, which we have begun to publish, provide clinical insights around patient management, device settings and predictors of patient adherence that inform our product development efforts.

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.

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.

New product ideas are also identified by our marketing staff, direct sales force and network of distributors, customers, clinicians and patients.

New product ideas are also identified by our marketing staff, direct sales force, and clinicians.

Sales and Marketing

We currently market our products in more than 140 countries through a network of distributors and our direct sales force.

We attempt to tailor our marketing approach to each national market, based on regional awareness of sleep apnea as a health problem, physician referral patterns, consumer preferences and local reimbursement policies.

We currently market our products in more than 140 countries through a network of distributors and direct sales staff.

We attempt to tailor our marketing approach to each major geography, often based on regional awareness of sleep apnea as a health problem, physician referral patterns, consumer preferences, and local reimbursement policies.

See Note 13 – Segment Information of the Notes to Consolidated Financial Statements (Part II, Item 8) for financial information about our geographic areas.

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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:

the prescribing physician and their staff;

the home healthcare dealer;

the insurer and the patient.

prescribing practitioners;

home healthcare dealers;

insurers (both private and public);

and patients.

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.

Our field sales organization markets and sells products to home healthcare dealer branch locations throughout the United States, Canada, and Latin America.

We also market our products directly to physicians and sleep clinics.

We also directly educate physicians and sleep clinics about our products.

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.

The home healthcare dealer, in consultation with the referring physician, will assist the patient in selecting the equipment, fit the patient with the appropriate mask and set the device pressure to the prescribed level.

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.

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

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

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.

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

and our primary markets are senior living;

and our primary customers are senior living;

skilled nursing;

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home health, home care, and hospice agencies as well as related accountable care organizations.

Our MatrixCare management solutions are primarily sold through direct sales and ancillary solutions are sold both through direct sales and channel partners.

Our MatrixCare management solutions are primarily sold through direct sales and ancillary solutions are sold both through direct sales and channel sellers.

Combined Europe, Asia, and other markets.

We market our products in most major countries in combined Europe, Asia and other markets.

We market our products in most major countries in combined Europe, Asia and other geographies.

We have wholly owned subsidiaries in Australia, Austria, China, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Sweden, Switzerland, Taiwan, Thailand, and the United Kingdom.

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

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.

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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 business models, in which we provide products and services directly to patients.

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

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We only sell our SaaS products in the United States;

however we will also have sales in Germany once ResMed’s acquisition of MEDIFOX DAN is complete.

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

Manufacturing

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

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

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

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.

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

We also purchase uniquely configured components from various suppliers, including some who are single-source suppliers for us.

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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 COVID-19 pandemic has continued to impact the global supply chain, primarily through constraints on raw materials and electronic components, including semiconductor chips.

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.

Additionally, we have observed a reduction in both inbound and outbound transportation capacity as a result of port closures and delays associated with the pandemic, which is causing longer lead times in receiving raw materials into and distributing finished goods out of our manufacturing facilities, as well as increased freight costs.

We are actively working to mitigate the impact of the widespread supply chain and logistics issues.

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.

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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).

Our main manufacturing facilities are located in Tuas, Singapore;

Our Sydney manufacturing operation operates an Environmental Management System (EMS) certified to ISO 14001:2015.

We are progressively extending the EMS across our manufacturing network.

Our main manufacturing facilities for ResMed-branded products are located in Tuas, Singapore;

Sydney, Australia;

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Johor Bahru, Malaysia;

Atlanta, Georgia and Suzhou, China.

and Atlanta, Georgia.

The principal factory for our Curative-branded products is in Suzhou, China.

Our Narval-branded products are manufactured in Lyon, France.

Refer to Item 2 for additional details on these properties.

We will continue to expand and balance volume across our network to meet scale, cost, resilience, and environmental performance objectives, and to meet the needs of customers and patients.

Third-Party Coverage and Reimbursement

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In Germany and Korea, we receive payments directly from these payors.

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 adequate reimbursement from those payors.

In the United States, our products are purchased primarily by home healthcare dealers, hospitals or sleep clinics, who invoice third-party payors directly for reimbursement.

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.

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.

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, unnecessary or inappropriate.

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.

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 purchase or rental of our products, subject to constraints such as price controls or unit sales limitations.

In Australia, China, and some other foreign markets, 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.

In 2011, the Centers for Medicare & Medicaid Services, or CMS, implemented the Durable Medical Equipment, Prosthetics,

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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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.

CMS is required by law to recompete these contracts at least once every three years.

In addition, the 2010 Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, required CMS to roll out the competitive bidding process nationally or adjust prices in non-competitive bidding areas, also known as the non-bid or Round 3 areas, to match competitive bidding prices by 2016.

CMS phased in the new rates beginning January 1, 2016, and the rates became fully effective July 1, 2016.

The implementation of the competitive acquisition program has resulted in reduced Medicare payment for CPAP and respiratory assist devices, and related supplies and accessories in both competitive bidding areas and non-competitive bidding areas.

Through an Interim Final Rule issued in May 2018, CMS increased the fee schedule amounts for certain DME in non-bid areas that qualify as rural and non-contiguous, setting payment for these areas for June 1, 2018 to December 31, 2018 at a 50/50 blended reimbursement rate based on the pre-competitive bidding reimbursement rate and the adjusted reimbursement rate set through competitive bidding.

Due to the lapse of competitive bid contracts as of December 31, 2018, effective January 1, 2019, Medicare beneficiaries could receive DME from any Medicare-enrolled supplier during a temporary gap in the competitive bidding program between January 1, 2019 and December 31, 2020.

Pricing in competitive bidding areas and non-rural, contiguous non-bid areas continued to use adjusted fee schedule amounts, subject to annual Consumer Price Index (CPI) adjustments, during this temporary gap period beginning in 2019 through December 31, 2020.

On December 28, 2021, CMS released a Final Rule that, among other things, extended the blended fee schedule amounts for non-bid rural and non-contiguous areas through the end of the COVID-19 public health emergency, which has been renewed through October 13, 2022, and a blended fee schedule amount was implemented for all other areas for the same period.

CMS competed 16 product categories in Round 2021 of the DMEPOS competitive bidding program, which took effect on January 1, 2021 and extends through December 31, 2021.

There have been some revisions to the bidding methodology including the plan to implement surety bond requirements, lead item pricing, and setting reimbursement rates at the maximum winning bid rate instead of the median winning bid rate.

Although CMS previously expanded the categories of devices subject to competitive bidding to include non-invasive ventilators, or NIVs, starting in 2021, in response to the COVID-19 pandemic, CMS removed NIVs from Round 2021 of the DMEPOS Competitive Bidding Program.

Of the 15 remaining product categories that were bid for in Round 2021, CMS awarded competitive bidding contracts for only two categories, off-the-shelf (OTS) back braces and OTS knee braces.

All other product categories were removed from Round 2021.

Payment for the items where contracts were not awarded will be based on adjusted fee schedule amounts, pending further rulemaking.

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

The law extended the 2% Medicare sequester moratorium through March 31, 2022, and adjusted the sequester to 1% between April 1, 2022, and June 30, 2022 and reinstates the full 2% sequestration cut beginning July 1, 2022.

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.

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.

The implementation of the competitive bidding program has resulted in reduced Medicare payment for CPAP and respiratory assist devices, and related supplies and accessories in both competitive bidding areas and non-competitive bidding areas.

The last round of competitive bid contracts lapsed, effective January 1, 2019.

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.

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.

Further, the law eliminated the potential for an additional 4% Medicare sequester in 2022 due to statutory pay-as-you-go (PAYGO) requirement for one year.

The cuts will take effect in 2023 after adjournment of the first session of the 117th Congress.

The ACA, which was passed both to expand the number of individuals with healthcare coverage and to develop additional revenue sources, also included, among other things, a deductible excise tax equal to 2.3% of the price for which medical devices are sold in the United States on any entity that manufactures or imports medical devices, with limited exceptions, beginning in 2013.

However, this excise tax was subsequently suspended by the U.S.

Congress for medical device sales, beginning in 2016 and permanently repealed, effective January 1, 2020.

The ACA also provided for a number of Medicare regulatory requirements, including new face-to-face encounter requirements for DME and home health services.

Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA.

On June 17, 2021, the U.S.

Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA.

Prior to the Supreme Court’s decision, President Biden issued an executive order to initiate a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021 and remained open through August 15, 2021.

The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that

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include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

In addition, other legislative changes have been proposed and adopted since the 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 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through December 31, 2021, unless additional Congressional action is taken.

In addition, on January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

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

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.

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In some regions and for certain customers we also offer extended warranties on our devices for one to three years in addition to our limited warranty.

Warranties on mask systems are for 90 days.

Warranties on mask systems are typically 90 days.

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 for various reasons.

We receive returns of our products from the field

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for various reasons.

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

We provide for warranties and returns based on historical data.

The markets for our products and services are highly competitive.

We believe that the principal competitive factors in all of our markets are product features, value-added solutions, reliability and price.

Global competition for sales of our products and services is intense.

We believe that the principal competitive factors are product features, value-added solutions, quality, reliability and price.

Customer support, reputation and efficient distribution are also important factors.

We compete on a market-by-market basis with various companies, some of which have greater financial, research, manufacturing and marketing resources than us.

The disparity between our resources and those of our competitors may increase as a result of the trend towards consolidation in the healthcare industry.

In addition, some of our competitors are affiliates of customers of ours, which may make it difficult to compete with them.

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.

Our primary Sleep and Respiratory Care competitors include Philips BV;

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BMC Medical Co.

and regional and new entrant manufacturers seeking to enter our markets.

React Health Corporation;

and Lowenstein plus regional and new-entrant manufacturers.

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 pharmaceutical, by others could result in our products becoming obsolete or noncompetitive, which would harm our revenues and financial condition.

For our SaaS business, the market is highly competitive, rapidly evolving, and subject to changing technology, low barriers to entry, shifting customer needs and frequent introductions of new products and services.

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.

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.

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

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

An important factor in such competition may be the timing of market introduction of competitive products and solutions.

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

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Patents and Proprietary Rights and Related Litigation

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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.

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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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, 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 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 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.

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.

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 or a premarket approval, or PMA, before introducing it into the U.S.

The type of marketing authorization is generally linked to the classification of the device.

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.

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.

Our products currently marketed in the United States are marketed pursuant to 510(k) pre-marketing clearances and are either Class I or Class II devices.

The process of obtaining a Section 510(k) clearance generally requires the submission of performance data and often clinical data, which in some cases can be extensive, to demonstrate that the device is “substantially equivalent” to a device that was on the market before 1976 or to a device that has been found by the FDA to be “substantially equivalent” to such a pre-1976 device, a predecessor device is referred to as “predicate device.” As a result, FDA clearance requirements may extend the development process for a considerable length of time.

Certain SaaS applications may be classified as a medical device.

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.

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.

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.

before the 1976 Medical Device Amendments that established the 510(k) pathway or (b) brought to market after 1976 pursuant to the 510(k) pathway.

Such a predecessor device is referred to as “predicate device.” Devices that do not have such a predicate are typically classified as Class III by default and are required to undergo the stringent PMA pathway that includes provision of clinical evidence and trials.

The PMA process, which is reserved for new devices that are not substantially equivalent to any predicate device and for high-risk devices or those that are used to support or sustain human life, may take several years and require the submission of extensive performance and clinical information.

However, a sponsor may apply to the FDA to reclassify devices that do not have predicates to Class I or II if the device is of low to moderate risk.

If the FDA grants the application, such a device is termed a “de novo” device and is evaluated through the somewhat more flexible de novo approval pathway.

As a result, FDA clearance and approval requirements may extend the development process for a considerable length of time.

In addition, in some cases, the FDA may require additional review by an advisory panel, which can further lengthen the process.

The PMA process, which is reserved for new devices that are not substantially equivalent to any predicate device and for high-risk devices or those that are used to support or sustain human life, may take several years and requires the submission of extensive performance and clinical information.

Finally, there may be instances where the products we sell as a result of an acquisition are subject to further FDA review and clearance.

Medical devices can be marketed only for the indications for which they are cleared or approved.

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 510(k) clearance or PMA 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;

however, the FDA may review this determination to evaluate the regulatory status of the modified

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product at any time and may require the manufacturer to cease marketing and recall the modified device until 510(k) clearance or PMA approval is obtained.

however, the FDA may review this determination to evaluate the regulatory status of the modified product at any time and may require the manufacturer to cease marketing and recall the modified device until clearance or approval is obtained.

The manufacturer may also be subject to significant regulatory fines or penalties.

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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 510(k) clearance or PMA approval of devices, withdrawal of marketing approvals and criminal prosecutions.

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 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.

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

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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.

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As a general rule, demonstration of conformity of medical devices and their manufacturers with the Essential Requirements/GSPR must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use.

Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse

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events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

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

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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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• Devices placed on the market after May 26, 2021, benefiting from the described MDR transitional provisions.

The European Commission further extended provision of the MDR and IVDR through Regulation (EU) 2023/607, whereby manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC.

Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.

These provisions extend the transition period of devices through to December 31, 2027 or December 31, 2028 depending on device risk classification.

The MDR, among other things:

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• strengthens rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

We have received certification or initiated the MDR certification process at several locations, including Sydney, Australia;

We have received certification at several locations, including Sydney, Australia;

San Diego, California;

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We continue to transition our certification profile to meet the new MDR requirements.

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Other regulatory bodies

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We are subject to a number of laws and regulations that may restrict our business practices, including, without limitation, anti-kickback, false claims and transparency laws with respect to payments and other transfers of value made to physicians and other healthcare providers.

The government has interpreted these laws broadly to apply to the marketing and sales activities of manufacturers and distributors as well as revenue cycle management companies like us.

The federal Anti-Kickback Statute 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.

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.

Failure to satisfy all elements of an exception or safe harbor, however, does not necessarily lead to a violation of the federal Anti-Kickback Statute.

Because the Anti-Kickback Statute is an intent-based statute, each arrangement is subject to a facts and circumstances analysis to determine whether the requisite intent under the statute is present.

The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment or approval to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government.

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Private suits filed under the civil False Claims Act, known as qui tam actions, can be brought by individuals on behalf of the government.

These individuals may share in any amounts paid by the entity to the government in fines or settlement.

The federal Civil Monetary Penalties Law prohibits, among other things, the offering or transfer 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 services reimbursable by Medicare or a state healthcare program, unless an exception applies.

These individuals may share in any amounts paid by the entity to the government in fines, judgement, or settlement.

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.

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.

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, beginning in 2022, physician assistants, nurse practitioners and other practitioners, and (ii) ownership and investment interests held by such providers and their immediate family members.

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.

Applicable manufacturers are required to submit annual reports to CMS.

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have similar fraud and abuse statutes or regulations that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under government programs.

In addition, in the U.S., certain states also mandate implementation of commercial compliance programs, impose

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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restrictions on device manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to healthcare professionals and entities.

FCPA and Other Anti-Bribery and Anti-Corruption Laws

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Data Privacy and Security Laws

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 including health care providers and their business associates, as well as covered subcontractors.

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.

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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.

For example, the California Consumer Privacy Act, or the CCPA, became effective on January 1, 2020.

The CCPA gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing and receive detailed information about how their personal information is used by requiring covered companies to provide new disclosures to California consumers (as that term is broadly defined) and provide such consumers new ways to opt-out of certain sales of personal information.

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.

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.

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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, the California Privacy Rights Act, or CPRA, effective January 1, 2023, and replacing the CCPA, will impose additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data.

It will also create a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement.

In addition to California, several U.S.

states, including Colorado, Virginia, and Utah have adopted their own comprehensive data protection laws, with varying implementation dates starting January 1, 2023.

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.

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

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, the CCPA, the CPRA 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.

Similar privacy laws have been proposed at the federal level and in other states.

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 may seek to regulate—and/or restrict the use of—biometrics in the future.

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

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.

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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 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.

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

The GDPR imposes stringent data protection requirements for the processing of personal data in the European Economic Area, or EEA.

The GDPR has increased our obligations, for example, by requiring more robust disclosures to individuals, strengthening individual data rights, instituting procedures for mandatory and 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.

The GDPR also imposes strict rules on the transfer of personal data out of the EEA, including to the United States;

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

The United Kingdom has adopted the UK General Data Protection Regulation ("UK GDPR");

the EU GDPR and UK GDPR are herein referred to as GDPR.

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.

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.

The GDPR also imposes strict rules on the transfer of personal data out of the EEA or UK, including to the United States;

recent legal developments in Europe have created complexity regarding such transfers of personal data from the EEA to the United States.

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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.

European data protection law provides that EEA member states 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.

EEA member states may modify or impose additional conditions to be able to transmit electronic marketing communications.

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.

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 United Kingdom has adopted the UK General Data Protection Regulation ("UK GDPR"), which also has the potential to impose significant data protection fines up to the greater of £17.5 million or 4% of global turnover.

Further, the UK GDPR also provides for significant data protection fines up to the greater of £17.5 million or 4% of global turnover.

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.

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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 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.

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.

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

We intend to continue to comprehensively protect all personal information and to comply with all applicable laws regarding the protection of such information as well as to monitor developments regarding the use of AI that could be relevant to our products and services.

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.

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,

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Human Capital

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

Our Code of Business Conduct & Ethics, Diversity and Inclusion programs and other practices and policies on workplace behavior, discrimination and harassment, health and safety, and employee benefits reinforce this environment and facilitate talent attraction, retention, and development.

discrimination and harassment, health and safety, and employee benefits reinforce this environment and 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.

Of our employees and contingent workers, approximately 3,490 (34%) were located in the United States, Canada and Latin America, 2,740 (27%) in Asia, 1,590 (16%) in Australia and 2,320 (23%) in Europe.

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

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%.

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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 second year of building out a strategic BIDS practice that strives to impact people, patients, and products.

Our objectives include expanding Employee Resource Groups (“ERG”), creating and delivering learning & development opportunities in support of BIDS values, identifying new and different hiring practices & measurements, emphasizing accessibility & disability inclusion, promoting inclusive leadership behaviors & practices, and exploring new community partnerships for sourcing.

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.

Employee Resource Groups.

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

this is largely done through engaging employees in our ERG programs supported by employees who share a common interest in community building, professional development, improving corporate culture and delivering sustained business results.

We maintain our ERG chapters worldwide and currently have twelve groups:

Black, Asia-American-Pacific Islander, LGBTQIA+, Hispanic and Latin, Veterans, Women, Women in Sales, Women in SaaS, Parents, Differently Able, and Mosaics in Ireland and France that collectively focus on local and culturally appropriate inclusion-building needs.

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 the Director of Diversity to identify and provide awareness trainings for their teams.

In 2022, we launched a day of learning in each region for employees to learn more about diversity and inclusion with the theme of Unconscious Bias.

Additionally, we launched a BIDS Certificate program, and the Director of Diversity also delivered multiple trainings globally.

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.

Strategic Inclusive Development.

A Global Council of Ambassadors meets every two months to review and assess developments, observations, and impressions related to ongoing diversity and inclusion efforts.

In 2022, we updated our internal policies and Employee Handbook to formalize certain inclusivity initiatives.

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

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.

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.

Leadership Engagement.

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

Each ERG is supported by an Executive Sponsor.

Each ERG/Mosaic is supported by an Executive Sponsor.

Sourcing & Recruiting.

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

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Talent Development & Retention

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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.

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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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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 Safety & COVID-19 Related Measures

Employee Health & 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.

As the COVID-19 pandemic spread, we implemented and maintained significant changes that we determined were in the best interest of our employees.

These included work from home flexibility, adjusted attendance policies and additional safety measures for our on-site workforce.

We have since re-opened our offices, consistent with local public health guidance and protocols, and continue to support flexible working globally.

Employee Engagement & Wellbeing

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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.

Additionally, we have implemented a company-wide ResMed Day for our people to focus on their mental, social and physical health.

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.

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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