ResMed (RMD) 10-K risk factor changes: FY2021 vs FY2020
The 2021-06-30 10-K against the 2020-06-30 one, compared heading by heading and sentence by sentence.
Item 1A68 rewritten127 added47 removed377 unchanged
All filing items871 rewritten563 added430 removed1,966 unchanged
Summary
counted, not written
- Item 1A lists 34 risk factor headings: 1 new, 2 reworded and 31 unchanged since FY2020. 5 headings from FY2020 no longer appear.
- Sentence by sentence, 563 added, 430 removed, 871 rewritten and 1,966 unchanged across 21 items that differ.
New Item 1A headings (1)
- We may not be able to realize the anticipated benefits from acquisitions, which could adversely affect our operating results.
Removed Item 1A headings (5)
- If we fail to effectively integrate and capitalize on our acquisitions, combining them with our other SaaS operations, our SaaS businesses could suffer.
- We have made certain assumptions relating to our recent acquisitions that may prove to be materially inaccurate.
- You may not be able to enforce the judgments of U.S. courts against some of our assets or officers and directors.
- We may be adversely affected by recent proposals to reform LIBOR.
- We may impair intangible assets, such as goodwill.
Reworded Item 1A headings (2)
- If our SaaS products fail to perform properly
[removed: and][added: or] if we fail to develop enhancements, we could lose customers, become subject to service performance or warranty claims and our market share could decline. - If there are interruptions or performance problems associated with our technology or infrastructure, our existing SaaS customers may experience service outages, and our new customers may experience delays in the deployment of our
[removed: platform.][added: platforms.]
A heading is new when no FY2020 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
22 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2021; struck-through words were in FY2020. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. RISK FACTORS
68 rewritten, 127 added, 47 removed, 377 unchanged
[removed: Before] [added: *Before] deciding to purchase, hold or sell our common stock, you should carefully consider the risks described below in addition to the other cautionary statements and risks described elsewhere, and the other information contained, in this Report and in our other filings with the SEC, including our subsequent reports on Forms 10-Q and 8-K.
In that event, the market price for our common stock will likely decline, and you may lose all or part of your [removed: investment.][added: investment.*]
If we are unable to develop innovative new products, maintain competitive pricing, and offer products that consumers perceive to be as good as those of our competitors, our sales [removed: or] [added: and] gross margins could decrease which would harm our business.
Consolidation in the health care industry could have an adverse effect on our revenues and results of operations. Many home health care dealers and out-of-hospital health providers are consolidating, which may result in greater concentration of [removed: market] [added: purchasing] power.
Our ability to manage our growth effectively depends on our ability to implement and improve our financial and management information systems on a timely basis and to effect other changes in our business [removed: including,] [added: including] the ability to monitor and improve manufacturing systems, information technology, and quality and regulatory compliance systems, among others.
Our business, financial condition and results of operations could be harmed by the effects of the COVID-19 pandemic. We are subject to risks related to the global pandemic associated with COVID-19, which [removed: may] have [added: had] an adverse impact on certain aspects of our business.
Specifically, diagnostic pathways for sleep apnea treatment, including physician practices, HME suppliers and sleep clinics, have been impacted and, in some instances, been required, [removed: or in the future may be required,] to temporarily close due to governments’ “shelter-in-place” orders, quarantines or similar orders or restrictions enacted to control the spread of COVID-19.
Our SaaS business [removed: may] [added: has] also [removed: be] [added: been] affected by COVID-19 and measures taken to control the spread of COVID-19.
Some of our existing and potential SaaS customers are HME distributors [removed: and, therefore,] [added: and] have been [removed: impacted, or may be impacted,] [added: impacted] by the same temporary business closures noted above.
We also have existing and potential SaaS customers that operate care facilities and are either receiving and treating patients infected with COVID-19 or [removed: are implementing] [added: have implemented] significant measures to safeguard their facilities against a potential COVID-19 outbreak.
Given these challenging business [removed: conditions and the uncertain economic environment, we expect] [added: conditions,] businesses [removed: will] [added: may] be deterred from adopting new or changing SaaS platforms, which may adversely impact our ability to engage new customers for our SaaS businesses, or expand the services used by existing customers.
[removed: If we are unable] [added: These disruptions may, among other things, impact our ability] to [removed: move products efficiently through the] [added: produce and] supply [removed: chain we may be unable] [added: products in quantities necessary] to satisfy customer demand, which could negatively impact our results of operations.
In addition to existing travel restrictions, countries may continue to close borders, impose prolonged quarantines, and [removed: further] restrict travel, which [added: have disrupted and] may [removed: also] [added: continue to] disrupt our ability to move our product by air and sea.
While we expect COVID-19 to negatively impact certain aspects of our business, given the rapid and evolving nature of the virus and the uncertainty about its impact on society and the global economy, we cannot predict the extent to which it will affect our global [removed: operations, particularly if these impacts persist or worsen over an extended period of time.][added: operations.]
Sales in combined Europe, Asia and other markets accounted for approximately [removed: 38% and] 39% [added: and 38%] of our net revenues in the years ended June 30, [removed: 2020] [added: 2021] and June 30, [removed: 2019] [added: 2020] respectively.
[removed: If we fail] [added: We may not be able] to [removed: effectively integrate and capitalize on our] [added: realize the anticipated benefits from] acquisitions, [removed: combining them with our other SaaS operations, our SaaS businesses] [added: which] could [removed: suffer.] [added: adversely affect our operating results.] Part of our growth strategy includes acquiring businesses consistent with our commitment to innovation in developing products for the diagnosis and treatment of sleep apnea and respiratory care as well as our SaaS business.
While [removed: management has] [added: we have] made such assumptions in good faith and [removed: believes] [added: believe] them to be reasonable, the assumptions may turn out to be materially inaccurate, including for reasons beyond our control.
[removed: If these assumptions] [added: Our business activities] are [removed: incorrect we may change or modify our assumptions,] [added: subject to extensive regulation,] and [removed: such change or modification] [added: any failure to comply] could have a material adverse effect on our [added: business,] financial [removed: condition] [added: condition,] or results of operations.
Under the program, our customers who provide [removed: HME] [added: DME] must compete to offer products in designated competitive bidding areas, or CBAs.
On March 7, 2019, CMS announced it would initiate a new round of competitive bidding, named Round 2021, with contracts [removed: expected to become] effective on January 1, [removed: 2021, and extend] [added: 2021] through December 31, 2023.
In addition to adopting new bidding processes, CMS expanded the product categories included in competitive bidding to include non-invasive [removed: ventilators, in addition to oxygen.][added: ventilators.]
CPAP, and respiratory assist devices, and related supplies and accessories, which had been included in prior rounds of competitive bidding, [removed: remain] [added: were] included in [added: the 15 remaining product categories that were bid for in] Round 2021.
[removed: We] [added: At this time, we] cannot predict [removed: at this time] the full impact the competitive bidding program and the developments in the competitive bidding program will have on our business and financial condition.
This excise tax was applicable to our products that are primarily used in hospitals and sleep labs, which includes the ApneaLink, VPAP [removed: Tx,] [added: Tx and] certain Respiratory Care [removed: and dental sleep] products.
In addition to the competitive bidding changes discussed above, the ACA also included, among other things, [removed: demonstrations] [added: directions] to develop organizations that are paid under a new payment methodology for voluntary coordination of care by groups of providers, such as physicians and hospitals, and the establishment of a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research.
The CARES Act, which was signed into law in March [removed: 2020,] [added: 2020 and subsequently amended,] suspended the payment reductions from May 1, 2020 through December 31, 2020, and extended the sequester by one additional year, through 2030.
It is [removed: also] unclear how other [removed: efforts] [added: healthcare reform measures of the Biden administration or other efforts, if any,] to challenge, repeal or replace the ACA will impact the ACA or our business.
The U.S. government has interpreted this law broadly to apply to the marketing and sales activities of [removed: manufacturers and] [added: manufacturers,] distributors [added: and revenue cycle management companies] like us.
federal civil and criminal false claims [removed: laws] [added: laws, including the False Claims Act,] and civil monetary penalty laws, that prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment or approval to the federal government that are false or fraudulent, knowingly making a false statement material to an obligation to pay or transmit money or property to the federal government or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay or transmit money or property to the federal government.
A person or entity does not need to have actual knowledge of these statutes or specific intent to violate them to have committed a [removed: violation.][added: violation;]
Beginning in 2022, applicable manufacturers also will be required to report such information regarding payments and transfers of value [removed: provided, as well as ownership and investment interests held,] [added: provided] during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse [removed: anesthetists] [added: anesthetists, anesthesiology assistants] and certified nurse midwives;
The agreement [removed: resolves] [added: resolved] five lawsuits originally brought by whistleblowers under the qui tam provisions of the False Claims Act and allegations that we: (a) provided DME companies with free telephone call center services and other free patient outreach services that enabled these companies to order resupplies for their patients with sleep apnea, (b) provided sleep labs with free and below-cost positive airway pressure masks and diagnostic machines, as well as free installation of these machines, (c) arranged for, and fully guaranteed the payments due on, interest-free loans that DME supplies acquired from third-party financial institutions for the purchase of our equipment, and (d) provided non-sleep specialist physicians free home sleep testing devices referred to as “ApneaLink.” We agreed with the government to civilly resolve these matters for a payment of $39.5 million ($37.5 million to the federal government and $2 million to the various states) and we incurred additional fees and administrative costs that typically accompany such a resolution amounting to $1.1 million.
Contemporaneous with the civil settlement, we also entered into a [added: five-year] Corporate Integrity Agreement, or CIA, with the Department of Health and Human Services Office of Inspector General.
The CIA [removed: requires,] [added: required,] among other things, that we implement additional controls around our product pricing and sales and that we conduct internal and external monitoring of our arrangements with referrals sources.
The settlement agreement with the government and the CIA could result in reputational [removed: harm,] [added: harm or] the curtailment or restructuring of our [removed: operations and an increase in our compliance costs,] [added: operations,] any of which could materially adversely affect our financial results and our ability to operate our business.
Our use and disclosure of individually identifiable information, including health information, is subject to federal, state and foreign privacy and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in significant liability or reputational harm. The privacy and security of personally identifiable information stored, maintained, received or transmitted electronically is a major issue in the [removed: United States] [added: U.S.] and abroad.
Concerns about our practices with regard to the collection, use, disclosure, [removed: or] security [added: or deletion] of personally identifiable information or other privacy-related matters, even if unfounded and even if we are in compliance with applicable laws, could damage our reputation and harm our business.
HIPAA establishes a set of national privacy and security standards for the protection of individually identifiable health information, or protected health information, by health plans, healthcare clearinghouses and healthcare providers that submit certain covered transactions electronically, or covered entities, and their “business associates,” which are persons or entities that perform certain services for, or on behalf of, a covered entity that involve creating, receiving, maintaining or transmitting protected health [removed: information.][added: information, as well as their covered subcontractors.]
In addition, the California Consumer Privacy Act of [removed: 2018] [added: 2018,] or [removed: CCPA] [added: CCPA,] became effective on January 1, 2020.
These laws and regulations are subject to frequent revisions and differing [removed: interpretations,] [added: interpretations] and have generally become more stringent over time.
Summary of Risk Factors
The following is a summary of the risks that are more fully described in the following section below:
Risks Related to Our Business and Industry
Our inability to compete successfully in our markets may harm our business.
Consolidation in the health care industry could have an adverse effect on our revenues and results of operations.
Our business, financial condition and results of operations could be harmed by the effects of the COVID-19 pandemic.
We are subject to various risks relating to international activities that could affect our overall profitability.
Our products are the subject of clinical trials conducted by us, our competitors, or other third parties, the results of which may be unfavorable, or perceived as unfavorable, and could have a material adverse effect on our business, financial condition, and results of operations.
We are subject to potential product liability claims that may exceed the scope and amount of our insurance coverage, which would expose us to liability for uninsured claims.
Our intellectual property may not protect our products, and/or our products may infringe on the intellectual property rights of third-parties.
If we fail to attract, develop and retain key employees our business may suffer.
Risks Related to Manufacturing, IT Systems, Commercial Operations and Plans for Future Growth
Disruptions in the supply of components from our suppliers could result in a significant reduction in sales and profitability.
We are increasingly dependent on information technology systems and infrastructure.
Actual or attempted breaches of security, unauthorized disclosure of information, denial of service attacks or the perception that personal and/or other sensitive or confidential information in our possession is not secure, could result in a material loss of business, substantial legal liability or significant harm to our reputation.
We may not be able to realize the anticipated benefits from acquisitions, which could adversely affect our operating results.
Our business depends on our ability to market effectively to dealers of home healthcare products and sleep clinics.
Our SaaS business depends substantially on customers entering into, renewing, upgrading and expanding their agreements for cloud services, term licenses, and maintenance and support agreements with us.
Any decline in our customer renewals, upgrades or expansions could adversely affect our future operating results.
If our SaaS products fail to perform properly or if we fail to develop enhancements, we could lose customers, become subject to service performance or warranty claims and our market share could decline.
If there are interruptions or performance problems associated with our technology or infrastructure, our existing SaaS customers may experience service outages, and our new customers may experience delays in the deployment of our platforms.
If we are unable to support our continued growth, our business could suffer.
If a natural or man-made disaster strikes our manufacturing facilities, we will be unable to manufacture our products for a substantial amount of time and our sales and profitability will decline.
Risks Related to Non-Compliance with Laws, Regulations and Healthcare Industry Shifts
Healthcare reform may have a material adverse effect on our industry and our results of operations.
Government and private insurance plans may not adequately reimburse our customers for our products, which could result in reductions in sales or selling prices for our products.
Failure to comply with anti-kickback and fraud regulations could result in substantial penalties and changes in our business operations.
Our use and disclosure of individually identifiable information, including health information, is subject to federal, state and foreign privacy and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in significant liability or reputational harm.
Product sales, introductions or modifications may be delayed or canceled as a result of FDA regulations or similar foreign regulations, which could cause our sales and profits to decline.
We are subject to substantial regulation related to quality standards applicable to our manufacturing and quality processes.
Our failure to comply with these standards could have an adverse effect on our business, financial condition, or results of operations.
Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business.
Off-label marketing of our products could result in substantial penalties.
Laws regulating consumer contacts could adversely affect our business operations or create liabilities.
Tax laws, regulations, and enforcement practices are evolving and may have a material adverse effect on our results of operations, cash flows and financial position.
We are subject to tax audits by various tax authorities in many jurisdictions.
Risks Related to the Securities Markets and Ownership of Our Common Stock
Our results of operations may be materially affected by global economic conditions generally, including conditions in the financial markets.
Our quarterly operating results are subject to fluctuation for a variety of reasons.
Delaware law and provisions in our charter and could make it difficult for another company to acquire us.
\-18\-
The impact on these diagnostic and prescription pathways has resulted and may continue to result in a decrease in demand for our products designed to treat sleep apnea.
While we have experienced increased demand for our respiratory care products due to the nature of COVID-19, we cannot guarantee that demand will continue or that we will be able to identify and obtain adequate raw materials or otherwise maintain operations, supply chains and distribution systems to satisfy demand for our products in a cost-effective manner or at all.
Additionally, if the increase in demand currently being experienced for our respiratory care products declines more abruptly than expected this could adversely impact our inventory levels and may result in excess inventory, which we may be unable to sell.
Additionally, the types of restrictions enacted to control the spread of COVID-19 have resulted in most of our employees working from home, and have resulted or may result in the employees of our key suppliers and customers working from home or, as noted above, not working at all.
Neither we nor our suppliers have significant experience operating with the majority of our work forces working from home and this may disrupt our standard operations or significantly hamper our products from moving through our supply chain.
The continued spread of COVID-19 has also led to extreme disruption and volatility in the global capital markets, which increases the cost of, and adversely impacts access to, capital and increases economic uncertainty.
We expect that sales within these areas will account for approximately 35-40% of our net revenues in the foreseeable future.
\-19\-
We have made certain assumptions relating to our recent acquisitions that may prove to be materially inaccurate. We have made certain assumptions relating to our recent acquisitions, including MatrixCare, such as:
projections of each acquired company’s future revenue;
the amount of goodwill and intangibles that will result from our acquisitions;
acquisition costs, including transaction, contingent consideration and integration costs; and
other financial and strategic rationales and risks of the acquisitions.
\-20\-
For example, on December 14, 2018, a U.S. District Court Judge in the Northern District of Texas, ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the U.S. Tax Act, the remaining provisions of the ACA are invalid as well.
On December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well.
On March 2, 2020, the United States Supreme Court granted the petitions for writs of certiorari to review this case, although it remains unclear when or how the Supreme Court will rule.
Further, failure to comply with the HIPAA privacy and security standards can result in significant civil monetary penalties per violation and, in certain circumstances, significant criminal penalties and/or imprisonment;
In addition, following the United Kingdom’s departure from the EU and the EEA on January 31, 2020 and the end of the transition period on December 31, 2020, we will have to comply with the GDPR and the GDPR as incorporated into the United Kingdom domestic law, the Data Protection Act 2018, the latter regime having the ability to separately fine up to the greater of £17.5 million or 4% of global turnover.
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.
Similarly, the new California Consumer Privacy Act of 2018 requires disclosure of our privacy practices to consumers.
In connection with the audit by the Australian Taxation Office, or ATO, for the tax years 2009 to 2013, we received Notices of Amended Assessments in March 2018.
Based on these assessments, the ATO asserted that we owe $151.7 million in additional income tax and $38.4 million in accrued interest.
We agreed to a payment arrangement with the ATO, whereby an amount of $75.9 million was paid by us in April 2018, with the remaining amounts due only if we are unsuccessful in defending our position.
In June 2018, we received a notice from the ATO claiming penalties of 50% of the additional income tax that was assessed or $75.9 million.
In accordance with the payment arrangement, all remaining tax, interest and penalty amounts outstanding are due only if we are unsuccessful in defending our position.
We do not agree with the ATO’s assessments and intend to pursue administrative and legal steps to defend our position.
However, if we are not successful, there may be material changes to our past or future taxable income, tax payable or deferred tax assets, we will not receive a refund of the $75.9 million we paid in April 2018, and we will be required to pay penalties and interest that could materially adversely affect our financial results.
The ATO is currently auditing tax years 2014 to 2018 and may advance the position that additional taxes are owed for those years as well.
You may not be able to enforce the judgments of U.S. courts against some of our assets or officers and directors. A substantial portion of our assets are located outside the United States.
Additionally, some of our directors and executive officers reside outside the United States, along with all or a substantial portion of their assets.
As a result, it may not be possible for investors to enforce judgments of U.S. courts relating to any liabilities under U.S. securities laws against our assets, those persons or their assets.
In addition, investors may not be able to pursue claims based on U.S. securities laws against these assets or these persons in non-U.S. courts, where most of these assets and persons reside.
Our results of operations may be materially affected by global economic conditions generally, including conditions in the financial markets. Recently, concerns over inflation, energy costs, geopolitical issues, the availability and cost of credit, the impact of the COVID-19 pandemic, and the ability of sovereign nations to pay their debts have contributed to increased volatility and diminished expectations for the economy and the financial markets going forward.
These factors, combined with volatile commodity prices, declining business and consumer confidence and increased unemployment, have precipitated an economic slowdown.
It is difficult to predict how long the current economic conditions will continue and whether the economic conditions will continue to deteriorate.
We may incur additional indebtedness in the future.
We may be adversely affected by recent proposals to reform LIBOR. Certain of our financial arrangements, including credit facilities, are made at variable interest rates that use the London Interbank Offered Rate, or LIBOR (or metrics derived from or related to LIBOR), as a benchmark for establishing the interest rate.
On July 27, 2017, the United Kingdom’s Financial Conduct Authority announced that it intends to stop persuading or compelling banks to submit LIBOR rates after 2021.
An excerpt. Shown here: 40 of 68 rewritten, 40 of 127 added and 40 of 47 removed. The counts are complete. For every sentence, read Item 1A. RISK FACTORS in the FY2021 filing and the FY2020 filing.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
105 rewritten, 131 added, 67 removed, 168 unchanged
Management’s discussion and analysis of financial condition and results of operations [added: (“MD&A”)] is intended to help the reader understand [removed: the] [added: our] results of operations and financial [removed: condition of ResMed Inc. and subsidiaries.][added: condition.]
It is provided as a supplement to, and should be read [removed: together] [added: in conjunction] with the selected financial data and consolidated financial statements and notes included [removed: elsewhere] in this report.
We are a global leader in the development, manufacturing, distribution and marketing of medical devices and cloud-based software applications that diagnose, treat and manage respiratory disorders, including [removed: sleep apnea,] [added: SDB,] COPD, neuromuscular disease and other chronic diseases.
[removed: Sleep apnea] [added: SDB] includes obstructive sleep apnea and other respiratory disorders that occur during sleep.
Since the development of continuous positive airway pressure therapy, we have expanded our business by developing or acquiring a number of products and solutions for a broader range of respiratory disorders including technologies to be applied in medical and consumer products, ventilation devices, diagnostic products, mask [removed: systems,] [added: systems for use in the hospital and home,] headgear and other accessories, dental devices, [removed: portable oxygen concentrators] and cloud-based software informatics solutions to manage patient outcomes and customer and provider business processes.
Our growth has been fueled by geographic expansion, our research and product development efforts, acquisitions and an increasing awareness of [removed: sleep apnea] [added: SDB] and other respiratory conditions like chronic obstructive pulmonary disease as significant health concerns.
During fiscal year [removed: 2020,] [added: 2021,] we invested [removed: $201.9] [added: $225.3] million on research and development activities, which represents [removed: 6.8%] [added: 7.0%] of net revenues with a continued focus on the development and commercialization of new, innovative products and solutions that improve patient outcomes, create efficiencies for our customers and help physicians and providers better manage chronic disease and lower healthcare costs.
Due to multiple acquisitions, including [removed: of] Brightree in April 2016, HEALTHCAREfirst in July 2018 and MatrixCare in November 2018, our operations now include out-of-hospital software platforms designed to support the professionals and caregivers who help people stay healthy in the home or care setting of their choice.
Net revenue in fiscal year [removed: 2020] [added: 2021] increased to [removed: $2,957.0] [added: $3,196.8] million, an increase of [removed: 13%] [added: 8%] compared to fiscal year [removed: 2019.][added: 2020.]
Gross profit increased for the year ended June 30, [removed: 2020] [added: 2021] to [removed: $1,717.8] [added: $1,839.1] million, from [removed: $1,494.1] [added: $1,717.8] million for the year ended June 30, [removed: 2019,] [added: 2020,] an increase [removed: $223.7] [added: $121.3] million or [removed: 15%.][added: 7%.]
Our net income for the year ended June 30, [removed: 2020] [added: 2021] was [removed: $621.7] [added: $474.5] million or [removed: $4.27] [added: $3.24] per diluted share compared to net income of [removed: $404.6] [added: $621.7] million or [removed: $2.80] [added: $4.27] per diluted share for the year ended June 30, [removed: 2019.][added: 2020.]
Total operating cash flow for fiscal year [removed: 2020] [added: 2021] was [removed: $802.3] [added: $736.7] million and at June 30, [removed: 2020,] [added: 2021,] our cash and cash equivalents totaled [removed: $463.2] [added: $295.3] million.
At June 30, [removed: 2020,] [added: 2021,] our total assets were [removed: $4.6] [added: $4.7] billion and our stockholders’ equity was [removed: $2.5] [added: $2.9] billion.
We paid a quarterly dividend of $0.39 per share during fiscal [removed: 2020] [added: 2021] with a total amount of [removed: $225.1] [added: $226.7] million paid to stockholders.
However, constant currency measures should not be considered in isolation or as an alternative to U.S. dollar measures that reflect current period exchange rates, or to other financial measures calculated and presented in accordance with [removed: U.S.] [added: accounting principles] generally accepted [removed: accounting principles.][added: in the United States (“GAAP”).]
For discussion related to the results of operations and changes in financial condition for the fiscal year ended June 30, [removed: 2019] [added: 2020] compared to fiscal year June 30, [removed: 2018,] [added: 2019,] please refer to Item 7 of Part II, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report for the Year Ended June 30, [removed: 2019,] [added: 2020,] which was filed with the United States Securities and Exchange Commission on August [removed: 18, 2019.][added: 13, 2020.]
[removed: Specifically, diagnostic] [added: Diagnostic] pathways for sleep apnea treatment, including [added: physician practices,] HME suppliers and sleep clinics, have been impacted and, in some instances, been required, [removed: or in the future may be required,] to temporarily close due to governments’ “shelter-in-place” orders, quarantines or similar orders or restrictions enacted to control the spread of COVID-19.
The impact on these diagnostic and prescription pathways has [removed: likely] resulted in a decrease in demand from new patients for our products designed to treat sleep apnea.
However, due to the nature of the installed base of existing patients using our devices, we [removed: expect the] [added: have not seen any significant adverse impact on] demand for re-supply of our [removed: masks to be less impacted compared to devices.][added: masks.]
Our SaaS business [removed: may] [added: has] also [removed: be] [added: been] affected by COVID-19 and measures taken to control the spread of COVID-19.
Some of our existing and potential SaaS customers are HME distributors [removed: and, therefore,] [added: and] have been [removed: impacted, or may be impacted,] [added: impacted] by the same temporary business closures noted above.
We also have existing and potential SaaS customers that operate care facilities and are either receiving and treating patients infected with COVID-19 or [removed: are implementing] [added: have implemented] significant measures to safeguard their facilities against a potential COVID-19 outbreak.
Given these challenging business [removed: conditions and the uncertain economic environment, we expect] [added: conditions,] businesses [removed: will] [added: may] be deterred from adopting new or changing SaaS platforms, which may adversely impact our ability to engage new customers for our SaaS businesses, or expand the services used by existing customers.
We have endeavored and continue to follow recommended actions of government and health authorities to protect our employees worldwide, but since COVID-19 was declared a pandemic in March 2020, we were able to broadly maintain our operations, and we are beginning the slow and careful process of progressively returning to work in [added: some of] our offices around the world.
Fiscal Year Ended June 30, [removed: 2020] [added: 2021] Compared to Fiscal Year Ended June 30, [removed: 2019][added: 2020]
Net Revenues. Net revenue for the year ended June 30, [removed: 2020] [added: 2021] increased to [removed: $2,957.0] [added: $3,196.8] million from [removed: $2,606.6] [added: $2,957.0] million for the year ended June 30, [removed: 2019,] [added: 2020,] an increase of [removed: $350.4] [added: $239.8] million or [removed: 13%] [added: 8%] (a [removed: 15%] [added: 6%] increase on a constant currency basis).
The following table summarizes our net revenue disaggregated by segment, product and region for the year ended June 30, [removed: 2020] [added: 2021] compared to the year ended June 30, [removed: 2019] [added: 2020] (in thousands):
| | | [removed: 2020] [added: 2021] | | | [removed: 2019] [added: 2020] | | | % Change | | | Constant Currency* | |
| Devices | | $ | [removed: 792,766] [added: 863,661] | | $ | [removed: 743,066] [added: 792,766] | | [removed: 7] [added: 9] | % | | | |
| Masks and other | | | [removed: 779,561] [added: 841,452] | | | [removed: 677,430] [added: 779,561] | | [removed: 15] [added: 8] | | | | |
| Total Sleep and Respiratory Care | | $ | [removed: 1,572,327] [added: 1,705,113] | | $ | [removed: 1,420,496] [added: 1,572,327] | | [removed: 11] [added: 8] | | | | |
| Software as a Service | | | [removed: 354,632] [added: 373,590] | | | [removed: 275,789] [added: 354,632] | | [removed: 29] [added: 5] | | | | |
| Total | | $ | [removed: 1,926,959] [added: 2,078,703] | | $ | [removed: 1,696,285] [added: 1,926,959] | | [removed: 14] [added: 8] | | | | |
| Devices | | $ | [removed: 715,056] [added: 746,379] | | $ | [removed: 618,525] [added: 715,056] | | [removed: 16] [added: 4] | % | | [removed: 19] [added: (2)] | % |
| Masks and other | | | [removed: 314,998] [added: 371,743] | | | [removed: 291,762] [added: 314,998] | | [removed: 8] [added: 18] | | | 11 | |
| Total Sleep and Respiratory Care | | $ | [removed: 1,030,054] [added: 1,118,122] | | $ | [removed: 910,287] [added: 1,030,054] | | [removed: 13] [added: 9] | | | [removed: 16] [added: 2] | |
| Devices | | $ | [removed: 1,507,822] [added: 1,610,040] | | $ | [removed: 1,361,591] [added: 1,507,822] | | [removed: 11] [added: 7] | % | | [removed: 12] [added: 3] | % |
| Masks and other | | | [removed: 1,094,559] [added: 1,213,195] | | | [removed: 969,192] [added: 1,094,559] | | [removed: 13] [added: 11] | | | [removed: 14] [added: 9] | |
| Total Sleep and Respiratory Care | | $ | [removed: 2,602,381] [added: 2,823,235] | | $ | [removed: 2,330,783] [added: 2,602,381] | | [removed: 12] [added: 8] | | | [removed: 13] [added: 6] | |
| Software as a Service | | | [removed: 354,632] [added: 373,590] | | | [removed: 275,789] [added: 354,632] | | [removed: 29] [added: 5] | | | [removed: 29] [added: 5] | |
During fiscal year 2021 we commenced a controlled product launch of AirSense 11, which will be followed by a broader launch throughout fiscal year 2022.
AirSense 11 will introduce new features such as a touch screen, algorithms for patients new to therapy and digital enhancements, such as over-the-air update capabilities.
Unrecognized tax benefits as described at note 14 – Income Taxes impacted our diluted earnings per share by $1.70 for the year ended June 30, 2021.
During the year ended June 30, 2021, we observed immaterial incremental demand for our ventilator devices and masks associated with the COVID-19 pandemic.
Although there is still substantial uncertainty, we believe the global demand for ventilators and other respiratory support devices used to treat COVID-19 patients has largely been met.
As such, we do not expect material COVID-19-generated demand for our ventilator products for the fiscal year ending June 30, 2022.
Although certain governments have begun to reduce or remove COVID-19 restrictions and implement vaccination programs to varying degrees, we are uncertain as to the duration and extent of the impact on demand for our sleep devices.
The increase was predominantly due to continued growth in resupply service offerings.
The decrease in gross margin was due primarily to product mix changes, declines in average selling prices and geographic mix changes, partially offset by lower amortization of acquired intangibles.
The constant currency decrease in selling, general and administrative expenses was primarily due to decreases in travel and entertainment and bad debt expenses, partially offset by increases in employee-related expenses.
Restructuring Expenses. In November 2020, we closed our POC business, which was part of the Sleep and Respiratory Care segment.
During the year ended June 30, 2021, we recognized restructuring expenses of $13.9 million primarily related to inventory write-downs of $5.2 million, accelerated amortization of acquired intangible assets of $5.1 million, asset impairments of $2.3 million, employee-related costs of $0.7 million and contract cancellation costs of $0.6 million.
Of the total expense recognized during the year ended June 30, 2021, the inventory write-down of $5.2 million is presented within cost of sales and the remaining $8.7 million in restructuring costs is separately disclosed as restructuring expenses on the consolidated statements of income.
We do not expect to incur additional expenses in connection with this activity in the future.
The decrease was partially due to a decrease in interest expense to $24.0 million for the year ended June 30, 2021 compared to $40.3 million for the year ended June 30, 2020.
Additionally, we recognized an unrealized gain of $14.5 million on our marketable and non-marketable securities for the year ended June 30, 2021, whereas during the year ended June 30, 2020, we recorded an impairment of $14.5 million on our non-marketable equity securities.
The increase in our effective income tax rate was primarily the result of an increase in unrecognized tax benefits as outlined below.
Excluding the impact of the unrecognized tax benefit, our effective income tax rate for the year ended June 30, 2021 was 18.2%.
We are under audit by the Australian Taxation Office (the “ATO”) for the years 2009 to 2018 (the “Audit Period”).
The audits primarily involve a transfer pricing dispute in which the ATO asserts we should have paid additional Australian taxes on income derived from our Singapore operations.
The ATO issued Notices of Amended Assessments for the tax years 2009 to 2013 seeking a total of $266.0 million, consisting of $151.7 million in additional income tax and $114.3 million in penalties and interest.
The 2014 to 2018 periods are still under audit and we have not yet received any Notices of Amended Assessments relative to those periods.
A total of $98.8 million in tax has been prepaid in relation to the Audit Period, which is consistent with ATO procedural audit practice.
We are engaged in advanced discussions with the ATO to settle the dispute for the entire Audit Period.
Given the stage of those discussions, during the year ended June 30, 2021, we recorded $395.3 million of gross unrecognized tax benefits, including $47.5 million of accrued interest and penalties.
This translates to a net amount of $248.7 million of net unrecognized tax benefits after taking into account tax credits and deductions of $146.6 million.
If we are not successful in litigation, we will be required to pay some or all of the additional income tax, accrued interest and penalties, including potential additional amounts relating to the 2014 to 2018 periods.
Unrecognized tax benefits as described at note 14 – Income Taxes reduced our diluted earnings per share for the year ended June 30, 2021 by $1.70 per share.
Summary of Non-GAAP Financial Measures
In addition to financial information prepared in accordance with GAAP, our management uses certain non-GAAP financial measures, such as non-GAAP revenue, non-GAAP cost of sales, non-GAAP gross profit, non-GAAP gross margin, non-GAAP income from operations, non-GAAP net income, and non-GAAP diluted earnings per share, in evaluating the performance of our business.
We believe that these non-GAAP financial measures, when reviewed in conjunction with GAAP financial measures, can provide investors better insight when evaluating our performance from core operations and can provide more consistent financial reporting across periods.
For these reasons, we use non-GAAP information internally in planning, forecasting, and evaluating the results of operations in the current period and in comparing it to past periods.
These non-GAAP financial measures should be considered in addition to, and not superior to or as a substitute for, GAAP financial measures.
We strongly encourage investors and shareholders to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
Non-GAAP financial measures as presented herein may not be comparable to similarly titled measures used by other companies.
The measure “non-GAAP revenue” is equal to GAAP net revenue once adjusted for deferred revenue fair value adjustments applied in the purchase accounting for previous business combinations.
The measure “non-GAAP cost of sales” is equal to GAAP cost of sales less amortization of acquired intangible assets relating to cost of sales and restructuring expense associated with inventory write-downs following the closure of the POC business.
The measure “non-GAAP gross profit” is the difference between non-GAAP revenue and non-GAAP cost of sales, and “non-GAAP gross margin” is the ratio of non-GAAP gross profit to non-GAAP revenue.
These non-GAAP measures are reconciled to their most directly comparable GAAP financial measures below (in thousands, except percentages):
| | | | | | | | | |
During fiscal year 2020, we released new products including AirFit N30, a nasal cradle mask with a front-facing tube, and AirFit F30i, a top-of-head connected full face mask as well as expanded our AirView offering to include certain respiratory care devices.
\-38\-
We have observed increased demand for our ventilator devices and masks, which can be used to treat COVID-19 patients.
Due to governments’ varying restrictions on international and domestic travel, access to labor for our manufacturing facilities was impacted as was the availability of raw materials and components, which constrained our manufacturing capacity and restricted our ability to initially meet the substantial demand for ventilators.
Our primary focus is maximizing the availability of our ventilators and other respiratory support devices for the patients that need them the most in the countries facing the greatest challenges.
The global increase in our sales for these respiratory care products during fiscal year 2020 generally followed infection patterns around the world.
We believe the global demand for these devices has largely been met, however, this may change depending on the ability for regions to contain and control infection rates, which remains highly uncertain.
Additionally, as more becomes known about the virus and as governments pursue testing and vaccines, we may see an overall reduction in demand, and then face a corresponding risk of oversupply by us and by our competitors.
While further outbreaks in the future are highly uncertain, we expect lower demand for ventilator products for the fiscal year ending June 30, 2021.
As anticipated, we observed lower demand for our sleep devices and masks during the three months ended June 30, 2020, and we continue to expect COVID-19 will lead to a temporary decrease in demand for these products from new patients for some or all of our fiscal year 2021.
Given the ongoing uncertainty regarding the duration and extent of the COVID-19 pandemic and measures taken to control the spread of COVID-19, we are uncertain as to the duration and extent of decreased demand for our sleep devices.
\-39\-
\-40\-
The increase was predominantly due to revenue attributable to MatrixCare, which was acquired on November 13, 2018, and continued growth in our SaaS product offerings.
Gross Profit and Gross Margin. Within our consolidated statements of income for the years ended June 30, 2020, 2019 and 2018, cost of sales has been adjusted to include amortization of acquired intangible assets directly applicable to revenue.
As a result, gross profit now includes amortization of acquired intangible assets relating to cost of sales and operating expenses have been reduced by this amount.
There was no impact on income from operations, income before taxes or net income, as a result of this reclassification.
The adjustments to the previously reported amounts are not material.
The table below presents a reconciliation of amortization of acquired intangible assets by income statement caption summing to total amortization of acquired intangible assets as previously reported for the year ended June 30, 2019 (in thousands):
| | | | |
| --- | --- | --- | --- |
| | | 2019 | |
| Amortization of acquired intangible assets related to cost of sales | | $ | 42,514 |
| Amortization of acquired intangible assets related to operating expenses | | | 32,424 |
| Total as previously reported | | $ | 74,938 |
The table below presents a reconciliation of gross profit as previously reported for the year ended June 30, 2019 adjusted for the amortization of acquired intangible assets now included in cost of sales (in thousands):
| Gross profit as previously reported | | $ | 1,536,585 |
| Amortization of acquired intangible assets related to cost of sales | | | (42,514) |
| Gross profit | | $ | 1,494,071 |
The increase in gross margin was due primarily to favorable product mix, which was partially offset by an increase in manufacturing and logistics costs as a result of the COVID-19 pandemic and an increase in amortization of intangible assets associated with MatrixCare and Propeller Health, which were acquired in November 2018 and January 2019, respectively.
The constant currency increase in selling, general and administrative expenses was primarily due to additional personnel to support our commercial activities and additional expenses associated with the consolidation of our acquisitions of MatrixCare and Propeller Health, partially offset by a decrease in legal costs and travel, marketing and consulting expenses, either as a direct or indirect result of the COVID-19 pandemic.
\-41\-
The decrease in amortization expense was attributable to our historical intangible assets becoming fully amortized during the fiscal year.
Restructuring Expenses. During the year ended June 30, 2020, we did not incur material restructuring expenses.
During the year ended June 30, 2019, we incurred restructuring expenses of $9.4 million associated with the reorganization, rationalization and relocation of some of our research and development and SaaS operations including the closure of our German research and development site.
We recorded the full amount of $9.4 million during the year ended June 30, 2019, within our operating expenses, which was separately disclosed as restructuring expenses.
The restructuring expenses consisted primarily of severance payments to employees and contract exit costs associated with several impacted sites.
Acquisition Related Expenses. During the year ended June 30, 2020, we did not incur material acquisition related expenses.
During the year ended June 30, 2019, we recognized acquisition related expenses of $6.1 million associated primarily with our acquisition of MatrixCare.
Litigation Settlement Expenses. During the year ended June 30, 2020, we did not incur material litigation settlement expenses.
An excerpt. Shown here: 40 of 105 rewritten, 40 of 131 added and 40 of 67 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS in the FY2021 filing and the FY2020 filing.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET AND BUSINESS RISKS
28 rewritten, 21 added, 12 removed, 38 unchanged
The table below provides information (in U.S. dollars) on our significant foreign-currency-denominated financial assets by legal entity functional currency as of June 30, [removed: 2020] [added: 2021] (in thousands):
| | | U.S. | | | | [removed: Great Britain | |] Canadian | | Chinese |
| | | Dollar | | Euro | | [removed: Pound | |] Dollar | | Yuan |
| | | (USD) | | (EUR) | | [removed: (GBP) | |] (CAD) | | (CNY) |
| AUD Functional: | | | | | | | | | [removed: | |]
| Foreign Currency Hedges | | \- | | [removed: (16,852) | |] \- | | [removed: \-] [added: (20,155)] | | [removed: (22,647)] [added: \-] |
| Net Total | | [removed: (1,919)] [added: \-] | | [removed: 1,578] [added: \-] | | [removed: (309)] [added: (5,309)] | | \- | [removed: | (4,262) |]
| USD Functional: | | | | | | | | | [removed: | |]
| Foreign Currency Hedges | | [removed: \-] [added: 40,000] | | \- | | \- | | [removed: (14,687) | |] \- |
| Net Total | | [removed: \-] [added: (70)] | | \- | | [removed: (134) | | (821)] [added: \-] | | \- |
| SGD Functional: | | | | | | | | | [removed: | |]
| Foreign Currency Hedges | | [removed: (295,000) | | (73,025)] [added: (200,000)] | | \- | | \- | | \- |
The table summarizes information on instruments and transactions that are sensitive to foreign currency exchange rates, including foreign currency call options, collars and forward contracts held at June 30, [removed: 2020.][added: 2021.]
| Foreign Exchange Contracts | | Year 1 | | Year 2 | | Total | | June [removed: 30, 2020] [added: 30,2021] | | June [removed: 30, 2019] [added: 30,2020] |
| Contract amount | | [removed: \-] [added: 20,155] | | \- | | [removed: \-] [added: 20,155] | | [removed: \-] [added: (44)] | | [removed: 202] [added: (83)] |
| Ave. contractual exchange rate | | [added: AUD 1 = USD 0.7521] | | | | [added: AUD 1 = USD 0.7521] | | | | |
| Ave. contractual exchange rate | | AUD 1 = [removed: Euro 0.6293] [added: Euro 0.6307] | | AUD 1 = [removed: Euro 0.58] [added: Euro 0.6700] | | AUD 1 = [removed: Euro 0.6211] [added: Euro 0.6382] | | | | |
| Contract amount | | [removed: 84,260] [added: 29,629] | | [removed: 5,617] [added: \-] | | [removed: 89,877] [added: 29,629] | | [removed: 126] [added: (88)] | | [removed: 40] [added: 126] |
| Ave. contractual exchange rate | | SGD 1 = [removed: Euro 0.6345] [added: Euro 0.6379] | | [removed: SGD 1 = Euro 0.6120] [added: \-] | | SGD 1 = [removed: Euro 0.6331] [added: Euro 0.6379] | | | | |
| Contract amount | | [removed: 295,000] [added: 200,000] | | \- | | [removed: 295,000] [added: 200,000] | | [removed: (183)] [added: (177)] | | [removed: 71] [added: (183)] |
| Ave. contractual exchange rate | | SGD 1 = [removed: USD 0.7176] [added: USD 0.7440] | | | | SGD 1 = [removed: USD 0.7176] [added: USD 0.7440] | | | | |
| Contract amount | | [removed: 22,647] [added: 12,387] | | \- | | [removed: 22,647] [added: 12,387] | | [removed: (161)] [added: (130)] | | [removed: (15)] [added: (161)] |
| Ave. contractual exchange rate | | AUD 1 = [removed: CNY 4.9450] [added: CNY 5.0312] | | | | AUD 1 = [removed: CNY 4.9450] [added: CNY 5.0312] | | | | |
| Contract amount | | [removed: 14,687] [added: 40,000] | | \- | | [removed: 14,687] [added: 40,000] | | [removed: (83)] [added: 169] | | [removed: (66)] [added: \-] |
| Ave. contractual exchange rate | | USD 1 = [removed: CAD 1.3695] [added: CAD 1.2431] | | | | USD 1 = [removed: CAD 1.3695] [added: CAD 1.2431] | | | | |
At June 30, [removed: 2020,] [added: 2021,] we held cash and cash equivalents of [removed: $463.2] [added: $295.3] million principally comprising of bank term deposits and at-call accounts and are invested at both short-term fixed interest rates and variable interest rates.
At June 30, [removed: 2020,] [added: 2021,] there was [removed: $680.0] [added: $158.0] million outstanding under the revolving credit and term loan facilities, which were subject to variable interest rates.
A hypothetical 10% change in interest rates during the year ended June 30, [removed: 2020,] [added: 2021,] would not have had a material impact on pretax income.
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | |
| Assets | | 456,660 | | 42,975 | | \- | | 13,012 |
| Liability | | (259,243) | | (81,722) | | \- | | (692) |
| Foreign Currency Hedges | | (195,000) | | \- | | \- | | (12,387) |
| Net Total | | 2,417 | | (38,747) | | \- | | (67) |
| Assets | | \- | | \- | | 22,396 | | \- |
| Liability | | \- | | \- | | (7,550) | | \- |
| EURO Functional: | | | | | | | | |
| Assets | | 2,825 | | \- | | \- | | \- |
| Liability | | (42,895) | | \- | | \- | | \- |
| Assets | | 406,966 | | 41,001 | | \- | | 899 |
| Liability | | (246,243) | | (10,877) | | \- | | \- |
| Net Total | | (39,277) | | 30,124 | | \- | | 899 |
\-54\-
| Contract amount | | 195,000 | | \- | | 195,000 | | (652) | | \- |
| Contract amount | | 47,406 | | 11,851 | | 59,257 | | 1,172 | | 886 |
| EUR/USD | | | | | | | | | | |
| Ave. contractual exchange rate | | EUR 1 = USD 1.912 | | | | EUR 1 = USD 1.912 | | | | |
\-55\-
| | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Assets | | 412,883 | | 139,175 | | \- | | \- | | 18,949 |
| Liability | | (414,802) | | (120,745) | | (309) | | \- | | (564) |
| Assets | | \- | | \- | | \- | | 19,472 | | \- |
| Liability | | \- | | \- | | (134) | | (5,606) | | \- |
| Assets | | 539,940 | | 145,999 | | \- | | \- | | 12 |
| Liability | | (238,584) | | (67,624) | | \- | | \- | | \- |
| Net Total | | 6,356 | | 5,350 | | \- | | \- | | 12 |
\-48\-
| Contract amount | | 61,791 | | 11,235 | | 73,026 | | 886 | | (124) |
\-49\-
Item 1. BUSINESS
92 rewritten, 125 added, 27 removed, 459 unchanged
Since the development of CPAP, we have expanded our business by developing or acquiring a number of innovative products and solutions for a broad range of respiratory disorders including technologies to be applied in medical and consumer products, ventilation devices, diagnostic products, mask systems for use in the hospital and home, headgear and other accessories, [removed: dental devices, portable oxygen concentrators, or POCs,] and [removed: cloud-based software informatics solutions to manage patient outcomes and customer and provider business processes.][added: dental devices.]
[removed: Today, we] [added: We] offer a comprehensive digital solution suite for patients with [removed: COPD,] [added: COPD or asthma,] including those using [removed: inhalers or supplemental oxygen] [added: inhalers,] as well as non-invasive or invasive ventilation.
We also provide management software to agencies providing out-of-hospital care, including home medical equipment, or HME, home health and hospice, skilled nursing, life plan [removed: community and] [added: community,] senior living, and private duty services.
[removed: These tools] [added: In addition, we] are [added: a leading provider of cloud-based software health applications and devices] designed to [removed: enable] [added: provide connected care, enabling] clinicians to manage more patients efficiently and effectively, as well as [removed: enable] [added: enabling] and [removed: encourage] [added: encouraging] patients’ long-term adherence to and satisfaction with their therapy.
We employ approximately [removed: 7,800] [added: 8,000] people and sell our products in [removed: approximately] [added: over] 140 countries through a combination of wholly owned subsidiaries and independent distributors.
Baxter acquired the rights to the technology in [removed: 1987,] [added: 1987] and sold CPAP devices in Australia from 1988 until our acquisition of the business.
Another study published in [added: *Lancet Respiratory* in] 2019 estimated that mild to severe OSA impacts more than 936 million people worldwide, including 54 million Americans.
Many healthcare professionals are often unable to diagnose OSA because they are unaware that such non-specific symptoms as excessive daytime sleepiness, snoring, [removed: hypertension] [added: hypertension,] and irritability are characteristic of OSA.
Sleep-Disordered Breathing and Obstructive Sleep Apnea. Sleep-disordered [removed: breathing] [added: breathing, or SDB,] encompasses all disease processes that cause abnormal breathing patterns during sleep.
CPAP was first used as a treatment for OSA in 1980 by Dr. Colin Sullivan, the past Chairman of our Medical Advisory Board and was commercialized for treatment of OSA in the United [removed: States] [added: States, or U.S.,] in the mid-1980s.
Our products cover patients ranging from those who only require therapy from CPAP systems at [removed: night,] [added: night] to those who are dependent on non-invasive or invasive ventilation for [removed: life-support and those who require portable oxygen concentrators, or POCs.][added: life-support.]
In March 2020, the World Health Organization declared the outbreak of a novel strain of coronavirus, [removed: or] COVID-19, as a pandemic.
We have observed increased demand for our ventilator devices and masks, and [removed: we are working] [added: during the first six months of the pandemic worked closely] with governments, health authorities, hospitals, [removed: physicians,] and [removed: patients worldwide] [added: physicians in over 100 countries] to assess their [removed: needs,] [added: needs] and [removed: to] deliver the ventilation therapy that is essential to treat the respiratory complications of COVID-19.
Our primary focus [added: 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.
Overlap Syndrome. In patients with [added: COPD-OSA] Overlap Syndrome, CPAP has been shown to provide benefits in relation to reducing mortality, decreasing hospitalizations and improving lung function and gas exchange.
In long-term COPD survivors with a history of [removed: congestive] [added: chronic] heart failure, LTOT is associated with a slowing of respiratory failure progression.
Our SaaS strategy is to develop a portfolio that assists durable [removed: medical equipment,] or [removed: DME, HME,] [added: home medical equipment (DME/HME) providers,] and other long-term care providers operate more effectively and efficiently across various out-of-hospital care settings.
Continue Product Development and Innovation in Sleep Apnea [added: and Respiratory Care] Products. We are committed to ongoing innovation in developing products for the diagnosis and treatment of sleep apnea.
In recent years we have introduced a full suite of masks in our AirTouch and AirFit [removed: ranges,] [added: ranges as well as] advanced and expanded the integrations of our therapy-based software solutions, including AirView, to promote greater patient [removed: adherence and during the COVID-19 pandemic, we released ResMed MaskSelector in the United States, an easy-to-use digital tool to make mask selection and sizing easier and more effective, both remotely and during in-person clinical setups.][added: adherence.]
[removed: In recent years,] [added: Likewise,] we [removed: launched Mobi, which is] [added: are committed to ongoing innovation of] our [removed: first ResMed\-branded portable oxygen concentrator as well as] [added: 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.
[removed: Additionally, we] [added: 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.
Studies have established a clinical association between OSA and both stroke and [removed: congestive] [added: chronic] heart failure, and have recognized sleep apnea as a cause of hypertension or high blood pressure.
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 [removed: oxygen,] non-invasive ventilation, and in-home life support ventilation to treat [removed: COPD.][added: COPD and other chronic respiratory diseases.]
Our portfolio of products includes devices, diagnostic products, mask systems, headgear and other accessories, dental [removed: devices, POCs] [added: devices] and cloud-based software informatics solutions.
For purposes of the following discussion, we refer to our air flow [removed: generators, ventilators] [added: generators] and [removed: oxygen concentrators] [added: ventilators] collectively as devices.
Devices in total accounted for approximately [removed: 51%, 52%] [added: 50%, 51%] and [removed: 56%] [added: 52%] of our net revenues in fiscal years [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018,] [added: 2019,] respectively.
Masks, diagnostic products and accessories together accounted for approximately [removed: 37%,] [added: 38%,] 37% and [removed: 38%] [added: 37%] of our net revenues in fiscal years [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018,] [added: 2019,] respectively.
| Minimalist | AirFit F30, AirFit [removed: P10] [added: P10,] and AirFit N30 minimalist masks feature our lightest, lowest profile designs. The features of these masks are focused on minimizing contact with the patient’s face to reduce red marks and irritation. |
| Freedom | AirFit N30i, AirFit [removed: P30i] [added: P30i,] and AirFit F30i freedom masks, which feature top-of-head tubing design allowing flexibility to easily switch sleep positions. |
| Ultra Soft | The AirTouch F20 [removed: mask features] [added: and AirTouch N20 masks feature] a soft and breathable AirTouch cushion designed to enhance CPAP mask comfort. |
| myAir | A personalized therapy management application for patients with [removed: sleep-disordered breathing] [added: sleep apnea] providing support, education and troubleshooting tools for increased patient engagement and improved compliance. |
| Connectivity Module | A module providing cellular connection between our compatible ventilation devices [removed: (i.e. Astral] [added: (e.g., Astral,] Stellar) and our AirView™ system. |
| Propeller Solutions | 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 [removed: while] promoting increased adherence to treatment. The Propeller Provider Portal gives clinicians the timely and accurate information they need to make better treatment decisions. |
SaaS revenue accounted for approximately 12%, [removed: 11%] [added: 12%] and [removed: 7%] [added: 11%] of our net revenue in fiscal years [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018,] [added: 2019,] respectively.
| 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 [removed: prosper in an ever-changing healthcare system.] [added: improve efficiencies and promote a better quality of life for the people they serve.] |
Studies have established a clinical association between untreated sleep apnea and systemic hypertension, diabetes, coronary artery disease, stroke, atrial fibrillation, [removed: congestive] [added: chronic] heart failure, and mortality.
We [added: also] continue to support some of the largest sleep apnea studies in history by performing advanced statistical analyses on millions of [added: real world] clinical data points [removed: using real-world data.][added: collected through our cloud-connected devices and patient engagement tools.]
United States, [removed: Canada] [added: Canada,] and Latin America. Our products are typically purchased by a home healthcare dealer who then sells the products to the patient.
The decision to purchase our products, as opposed to those of our competitors, is made or influenced by one or more of the following individuals or organizations: the prescribing physician and [removed: his or her] [added: their] staff; the home healthcare dealer; the insurer and the patient.
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 [removed: living,] [added: living;] skilled nursing; life plan communities; home health, home care, and hospice agencies as well as related accountable care organizations.
We also provide data management systems designed to improve the management of patients.
Between January 1 and June 30, 2020, ResMed produced over 150,000 ventilators –3.5 times more than the same period of time one year before.
Broaden our digital health technology foundation. Digital enablement is central to our strategy.
Our cloud-based digital health applications, along with our devices, are designed to provide connected care to improve patient outcomes and efficiencies for our customers, allowing fewer professionals to manage more patients and empower patients to track their own health outcomes.
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.
In 2021, we acquired Tong-il, another leading sleep and respiratory care HME provider in South Korea, reinforcing both our commitment and capability to serve millions of South Korean patients living with sleep apnea, COPD, and other chronic respiratory diseases.
We commenced a controlled product launch of AirSense 11 in fiscal year 2021, which will be followed by a broader launch throughout fiscal year 2022.
AirSense 11 will introduce new features such as a touch screen, algorithms for patients new to therapy and digital enhancements, such as over-the-air update capabilities.
| | |
| | |
| AirSense 10 AutoSet for Her | The first complete sleep therapy solution tailored for women. The AirSense 10 AutoSet for Her is based on ResMed’s AutoSet algorithm. It responds to female-specific characteristics of sleep apnea and is tailored to meet the special sleep needs of women. |
| | |
| AirCurve 10 ST-A | A bilevel device that provides effective non-invasive ventilation for patients with respiratory insufficiency from conditions including neuromuscular disease, restrictive lung disorders, COPD and hypoventilation syndromes. |
| | |
| | |
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.
| | |
| | |
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.
In Germany and Korea, we receive payments directly from these payors.
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.
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.
Payment for the items where contracts were not awarded will be based on adjusted fee schedule amounts, pending further rulemaking.
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 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.
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.
Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.
The implementation of cost containment measures or other healthcare reforms may have a material adverse impact on our revenues, profit margins, profitability, operating cash flows and results of operations.
The Medical Device Regulation thus became applicable on May 26, 2021.
Devices lawfully placed on the market pursuant to the EU Medical Devices Directive prior to May 26, 2021 may generally continue to be made available on the market or put into service until May 26, 2025.
The Medical Devices Regulation, among other things:
We have received certification or initiated the Medical Device Regulation certification process at several locations, including Sydney, Australia; San Diego, California; and Lyon, France.
We continue to transition our certification profile to meet the new Medical Device Regulation requirements.
Data Privacy and Security Laws
Further, the California Privacy Rights Act, or CPRA, recently passed in California and not only revises but expands upon CCPA.
Our growth has been fueled by geographic expansion, our research and product development efforts, acquisitions and an increasing awareness of sleep apnea and respiratory conditions like COPD as significant health concerns.
We are also a leading provider of cloud-based software health applications and devices designed to provide connected care, improving patient outcomes and efficiencies for healthcare providers.
We also offer stationary and portable battery-powered oxygen concentrators for the administration of long-term oxygen therapy in the home as well as data management systems designed to improve the management of patients.
Additionally, the continued impact of COVID-19 or a resurgence of COVID-19 may create more demand for our ventilator products.
Continue Product Development and Innovation in Respiratory Care Products. We are committed to ongoing innovation of our respiratory care products that serve the needs of patients with COPD and neuromuscular diseases.
With the addition of Inova Labs POCs and our non-invasive ventilator devices with masks and accessories, we intend to continue to expand and enhance our product offerings in this area.
| Mobi | A portable oxygen concentrator system with a lightweight design and extended battery life to promote greater mobility for patients on oxygen therapy. |
We have also begun presenting and publishing research findings based on the industry-leading connectivity platform and data assets that are unique to us.
We are establishing a new manufacturing facility in Tuas, Singapore that will eventually replace our Loyang facility.
CMS also extended the blended fee schedule amounts for non-bid rural and non-contiguous areas through December 31, 2020.
We cannot predict at this time the full impact that the ACA, or any U.S. legislation enacted in the future, will have on our revenues, profit margins, profitability, operating cash flows and results of operations.
There have been judicial and Congressional challenges to certain aspects of the ACA, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the ACA, and we expect such challenges and amendments to continue.
For example, the Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On December 14, 2018, a U.S. District Court Judge in the Northern District of Texas ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the U.S. Tax Act, the remaining provisions of the ACA are invalid as well.
On December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well.
On March 2, 2020, the U.S. Supreme Court granted the petitions for writs of certiorari to review this case, although it is unclear when or how the Supreme Court will rule.
It is also unclear how other efforts to challenge, repeal or replace the ACA will impact the law or our business.
Once applicable, the new regulations will among other things:
These modifications may have an impact on the way we design and manufacture products and the way we conduct our business in the EEA.
We are progressing in our plans to meet the new requirements.
Violations of the federal Anti-Kickback Statute may result in significant civil monetary penalties for each violation, plus up to three times the remuneration involved.
Violations of the Federal Anti-Kickback Statute can also result in criminal penalties, including significant criminal fines and imprisonment.
In addition, violations can result in debarment, suspension or exclusion from participation in government healthcare programs, including Medicare and Medicaid.
When an entity is determined to have violated the federal civil False Claims Act, the government may impose significant civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs.
Failure to submit required information may result in significant civil monetary penalties for each failure and additional penalties for “knowing failures”, for all payments, transfers of value or ownership or investment interests that are not timely, accurately, and completely reported in an annual submission, and may result in liability under other federal laws or regulations.
certified under the Privacy Shield scheme.
Further, following the United Kingdom’s departure from the EU and EEA on January 31, 2020 and the end of the transition period on December 31, 2020, we will have to comply with the GDPR and the GDPR as incorporated into the United Kingdom domestic law, the Data Protection Act 2018, the latter regime having the ability to separately fine up to the greater of £17.5 million or 4% of global turnover.
Employees
An excerpt. Shown here: 40 of 92 rewritten, 40 of 125 added and all 27 removed. The counts are complete. For every sentence, read Item 1. BUSINESS in the FY2021 filing and the FY2020 filing.
Item 3. LEGAL PROCEEDINGS
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See Note 17 – Legal Actions, Contingencies and Commitments of the Notes to Consolidated Financial Statements (Part II, Item 8) included in this [removed: report.][added: report, which is incorporated by reference herein.]
We investigate these matters as they arise, and accrue estimates for resolution of legal and other contingencies in accordance with Statement of Financial Accounting Standard No. 5.
Cover and table of contents
25 rewritten, 2 added, 0 removed, 72 unchanged
For the fiscal year ended June 30, [removed: 2020][added: 2021]
The aggregate market value of the voting and non-voting common equity held by non-affiliates of registrant as of December 31, [removed: 2019] [added: 2020] (the last business day of the registrant’s most recently completed second fiscal quarter), computed by reference to the closing sale price of such stock on the New York Stock Exchange, was [removed: $22,240,443,784.][added: $30,662,112,869.]
At August [removed: 7, 2020,] [added: 12, 2021,] registrant had [removed: 144,900,654] [added: 145,681,186] shares of Common Stock, $0.004 par value, issued and outstanding.
Portions of the registrant’s definitive Proxy Statement to be delivered to stockholders in connection with the registrant’s [removed: 2020] [added: 2021] Annual Meeting of Stockholders, to be filed subsequent to the date hereof, are incorporated by reference into Part III of this report.
| | Item 1A | [Risk Factors](#RISK_FACTORS) | [removed: 18] [added: 21] |
| | Item 1B | [Unresolved Staff Comments](#UNRESOLVED_STAFF_COMMENTS) | [removed: 34] [added: 39] |
| | Item 2 | [Properties](#PROPERTIES) | [removed: 34] [added: 39] |
| | Item 3 | [Legal Proceedings](#LEGAL_PROCEEDINGS) | [removed: 34] [added: 39] |
| | Item 4 | [Mine Safety Disclosures](#MINE_SAFETY_DISCLOSURES) | [removed: 34] [added: 39] |
| Part II | Item 5 | [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](#MARKETS_FOR_REGISTRANTS_COMMON_EQUITY) | [removed: 35] [added: 40] |
| | Item 6 | [Selected Financial Data](#SELECTED_FINANCIAL_DATA) | [removed: 37] [added: 42] |
| | Item 7 | [Management’s Discussion and Analysis of Financial Condition and Results of Operations](#MANAGEMENTS_DISCUSSION_AND_ANALYSIS) | [removed: 38] [added: 43] |
| | Item 7A | [Quantitative and Qualitative Disclosures About Market and Business Risks](#QUANTITATIVE_AND_QUALITATIVE_DISCLOSURES) | [removed: 48] [added: 54] |
| | Item 8 | [Consolidated Financial Statements and Supplementary Data](#CONSOLIDATED_FINANCIAL_STATEMENTS_AND_SU) | [removed: 50] [added: 56] |
| | Item 9 | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](#CHANGES_IN_AND_DISAGREEMENTS) | [removed: 82] [added: 86] |
| | Item 9A | [Controls and Procedures](#CONTROLS_AND_PROCEDURES) | [removed: 82] [added: 86] |
| | Item 9B | [Other Information](#OTHER_INFORMATION) | [removed: 86] [added: 89] |
| Part III | Item 10 | [Directors, Executive Officers and Corporate Governance](#DIRECTORS_EXECUTIVE_OFFICERS_AND_CORPOR) | [removed: 87] [added: 90] |
| | Item 11 | [Executive Compensation](#EXECUTIVE_COMPENSATION) | [removed: 87] [added: 90] |
| | Item 12 | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](#SECURITY_OWNERSHIP_OF_CERTAIN_BENEFICIAL) | [removed: 87] [added: 90] |
| | Item 13 | [Certain Relationships and Related Transactions, and Director Independence](#CERTAIN_RELATIONSHIPS_AND_RELATED) | [removed: 87] [added: 90] |
| | Item 14 | [Principal Accounting Fees and Services](#PRINCIPAL_ACCOUNTING_FEES_AND_SERVICES) | [removed: 87] [added: 90] |
| Part IV | Item 15 | [Exhibits and Consolidated Financial Statement Schedules](#EXHIBITS_AND_CONSOLIDATED_FINANCIAL_STAT) | [removed: 88] [added: 91] |
| | Item 16 | [Form 10-K Summary](#Item16_10K_Summary) | [removed: 89] [added: 92] |
| | | [Signatures](#SIGNATURES) | [removed: 90] [added: 93] |
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
x
Item 1B. UNRESOLVED STAFF COMMENTS
1 rewritten, 0 added, 0 removed, 0 unchanged
We have received no written comments regarding our periodic or current reports from the staff of the SEC that were issued 180 days or more before the end of our fiscal year [removed: 2020] [added: 2021] that remain unresolved.
Item 2. PROPERTIES
10 rewritten, 1 added, 1 removed, 12 unchanged
Other facilities are [removed: leased] in Atlanta, Georgia, and Moreno Valley, California, U.S.A.; [removed: Loyang and Galaxis,] Singapore; Munich, Germany; Lyon, France; Suzhou, China; and Johor Bahru, Malaysia.
We [removed: are establishing] [added: have established] a [removed: new] [added: new, purpose-built] manufacturing facility in Tuas, Singapore that [removed: will eventually replace] [added: has replaced] our [added: former] Loyang facility.
At June 30, [removed: 2020,] [added: 2021,] our principal owned and leased properties were as follows:
| | San Diego, California | Owned | 230,000 | | Corporate headquarters, [added: engineering, research and development,] sales and administration |
| | Atlanta, Georgia | Leased | 522,000 | | [removed: Warehouse] [added: Manufacturing, warehouse] and [removed: distribution;] [added: distribution,] SaaS sales and administration, engineering, research and development |
| | Munich, Germany | Leased | [removed: 109,000] [added: 60,000] | | Sales and distribution |
| | [removed: Loyang,] Singapore [added: (1)] | Leased | [removed: 95,000] [added: 299,000] | | [removed: Manufacturing facility,] [added: Manufacturing,] engineering, research and [removed: development] [added: development, sales and administration] |
| | Minneapolis, United States | Leased | [removed: 86,000] [added: 51,000] | | SaaS sales and administration, engineering, research and development |
| | Chatsworth, California | Leased | 72,000 | | [removed: Motor manufacturing,] [added: Manufacturing,] engineering, research and development |
| | Johor Bahru, Malaysia | Leased | 46,000 | | [removed: Engineering,] [added: Manufacturing, engineering,] research and development |
(1)Leased property in Singapore excludes our 95,000 square foot Loyang manufacturing facility, which was in the process of being vacated and did not have significant operations as of June 30, 2021.
| | Tuas, Singapore | Leased | 268,000 | | Future manufacturing facility, currently being established |
Item 4. MINE SAFETY DISCLOSURES
0 rewritten, 1 added, 1 removed, 6 unchanged
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Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
9 rewritten, 6 added, 6 removed, 25 unchanged
As of July 31, [removed: 2020,] [added: 2021,] there were [removed: 26] [added: 28] holders of record of our common stock, although the actual number of stockholders of our common stock is greater than this number of holders of record and many of these holders of record own shares as nominees on behalf of other beneficial owners.
In fiscal year 2019, we temporarily suspended our share repurchase program due to recent [removed: acquisitions.][added: acquisitions, and more recently, as a response to the COVID-19 pandemic.]
As a result, we did not repurchase any shares during the twelve months ended June 30, [removed: 2020.][added: 2021.]
At June 30, [removed: 2020,] [added: 2021,] 12.9 million additional shares can be repurchased under the approved share repurchase program.
The following graph compares the cumulative total stockholders return on our common stock from June 30, [removed: 2015] [added: 2016] through June 30, [removed: 2020,] [added: 2021,] with the comparable cumulative return of the S&P 500 index, the S&P 500 Health Care index, and the Dow Jones U.S. Medical Devices index.
The graph assumes that $100 was invested in our common stock and each index on June 30, [removed: 2015.][added: 2016.]
][added: 2](https://www.sec.gov/Archives/edgar/data/943819/000094381921000017/c819-20210630x10kg001.jpg)]
The following table shows total indexed return of stock price plus reinvestments of dividends, assuming an initial investment of $100 at June 30, [removed: 2015,] [added: 2016,] for the indicated periods.
| Index | [removed: 2015 |] 2016 | 2017 | 2018 | 2019 | 2020 | [added: 2021 |]
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| ResMed Inc. | 100 | 126 | 170 | 203 | 323 | 418 |
| S&P 500 | 100 | 115 | 130 | 140 | 148 | 205 |
| S&P 500 Health Care | 100 | 111 | 116 | 129 | 141 | 177 |
| Dow Jones U.S. Medical Devices | 100 | 123 | 148 | 178 | 195 | 266 |
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| ResMed Inc. | 100 | 115 | 144 | 195 | 233 | 370 |
| S&P 500 | 100 | 102 | 117 | 132 | 143 | 150 |
| S&P 500 Health Care | 100 | 96 | 106 | 112 | 125 | 136 |
| Dow Jones U.S. Medical Devices | 100 | 115 | 142 | 171 | 206 | 227 |
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Item 6. SELECTED FINANCIAL DATA
34 rewritten, 1 added, 4 removed, 15 unchanged
The following table summarizes certain selected consolidated financial data for, and as of the end of, each of the fiscal years in the five-year period ended June 30, [removed: 2020.][added: 2021.]
The consolidated statement of income data for the years ended June 30, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019] and the consolidated balance sheet data as of June 30, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] are derived from our audited consolidated financial statements included elsewhere in this report.
The consolidated statement of income data for the years ended June 30, [removed: 2017] [added: 2018] and [removed: 2016] [added: 2017] and the consolidated balance sheet data as of June 30, [removed: 2018, 2017] [added: 2019, 2018] and [removed: 2016] [added: 2017] are derived from our audited consolidated financial statements not included in this report.
| (In thousands, except per share data): | | [added: 2021 | | |] 2020 | | | 2019 | | | 2018 | | | 2017 | | [removed: | 2016 | |]
| Net revenue | | | [added: 3,196,825 | | |] 2,957,013 | | | 2,606,572 | | | 2,340,196 | | | 2,066,737 | [removed: | | 1,838,713 |]
| Cost of sales (exclusive of amortization shown separately below) | | | [added: 1,312,598 | | |] 1,189,624 | | | 1,069,987 | | | 978,032 | | | 864,992 | [removed: | | 772,216 |]
| Amortization of acquired intangible [removed: assets*] [added: assets] | | | [added: 45,127 | | |] 49,603 | | | 42,514 | | | 27,266 | | | 29,477 | [removed: | | 12,906 |]
| Total cost of sales | | | [added: 1,357,725 | | |] 1,239,227 | | | 1,112,501 | | | 1,005,298 | | | 894,469 | [removed: | | 785,122 |]
| Gross profit | | | [added: 1,839,100 | | |] 1,717,786 | | | 1,494,071 | | | 1,334,898 | | | 1,172,268 | [removed: | | 1,053,591 |]
| Selling, general and administrative expenses | | | [added: 670,387 | | |] 676,689 | | | 645,010 | | | 600,369 | | | 553,968 | [removed: | | 488,057 |]
| Research and development expenses | | | [added: 225,284 | | |] 201,946 | | | 180,651 | | | 155,149 | | | 144,467 | [removed: | | 118,651 |]
| Amortization of acquired intangible [removed: assets*] [added: assets] | | | [added: 31,078 | | |] 30,092 | | | 32,424 | | | 19,117 | | | 17,101 | [removed: | | 11,017 |]
| Restructuring expenses | | | [added: 8,673 | | |] \- | | | 9,401 | | | 18,432 | | | 12,358 | [removed: | | 6,914 |]
| Litigation settlement expenses | | | [added: \- | | |] (600) | | | 41,199 | | | \- | | | 8,500 | [removed: | | \- |]
| Acquisition related expenses | | | \- | | | [removed: 6,123] [added: \-] | | | [removed: \-] [added: 6,123] | | | [removed: 10,076] [added: \-] | | | [removed: \-] [added: 10,076] |
| Total operating expenses | | | [added: 935,422 | | |] 908,127 | | | 914,808 | | | 793,067 | | | 746,470 | [removed: | | 624,639 |]
| Income from operations | | | [added: 903,678 | | |] 809,659 | | | 579,263 | | | 541,831 | | | 425,798 | [removed: | | 428,952 |]
| Interest income (expense), net | | | [added: (23,627) | | |] (39,356) | | | (33,857) | | | (11,977) | | | (11,151) | [removed: | | 5,654 |]
| Loss attributable to equity method investments | | | [removed: (25,058)] [added: (11,205)] | | | [removed: (15,833)] [added: (25,058)] | | | [removed: \-] [added: (15,833)] | | | \- | | | \- |
| Other, net | | | [added: 14,816 | | |] (12,157) | | | (10,726) | | | (8,542) | | | 4,096 | [removed: | | 4,960 |]
| Total other income (loss), net | | | [added: (20,016) | | |] (76,571) | | | (60,416) | | | (20,519) | | | (7,055) | [removed: | | 10,614 |]
| Income before income taxes | | | [added: 883,662 | | |] 733,088 | | | 518,847 | | | 521,312 | | | 418,743 | [removed: | | 439,566 |]
| Income taxes | | | [added: 409,157 | | |] 111,414 | | | 114,255 | | | 205,724 | | | 76,459 | [removed: | | 87,157 |]
| Net income | | $ | [removed: 621,674] [added: 474,505] | | $ | [removed: 404,592] [added: 621,674] | | $ | [removed: 315,588] [added: 404,592] | | $ | [removed: 342,284] [added: 315,588] | | $ | [removed: 352,409] [added: 342,284] |
| Basic earnings per share | | $ | [removed: 4.31] [added: 3.27] | | $ | [removed: 2.83] [added: 4.31] | | $ | [removed: 2.21] [added: 2.83] | | $ | [removed: 2.42] [added: 2.21] | | $ | [removed: 2.51] [added: 2.42] |
| Diluted earnings per share | | $ | [removed: 4.27] [added: 3.24] | | $ | [removed: 2.80] [added: 4.27] | | $ | [removed: 2.19] [added: 2.80] | | $ | [removed: 2.40] [added: 2.19] | | $ | [removed: 2.49] [added: 2.40] |
| Dividends per share | | $ | 1.56 | | $ | [removed: 1.48] [added: 1.56] | | $ | [removed: 1.40] [added: 1.48] | | $ | [removed: 1.32] [added: 1.40] | | $ | [removed: 1.20] [added: 1.32] |
| Basic shares outstanding | | | [added: 145,313 | | |] 144,338 | | | 143,111 | | | 142,764 | | | 141,360 | [removed: | | 140,242 |]
| Diluted shares outstanding | | | [added: 146,451 | | |] 145,652 | | | 144,484 | | | 143,987 | | | 142,453 | [removed: | | 141,669 |]
| Consolidated Balance Sheet Data (In thousands): | | [added: 2021 | | |] 2020 | | | 2019 | | | 2018 | | | 2017 | | [removed: | 2016 | |]
| Working capital | | $ | [removed: 920,698] [added: 662,991] | | $ | [removed: 589,375] [added: 920,698] | | $ | [removed: 554,468] [added: 589,375] | | $ | [removed: 1,283,877] [added: 554,468] | | $ | [removed: 781,730] [added: 1,283,877] |
| Total assets | | | [added: 4,728,125 | | |] 4,587,376 | | | 4,107,682 | | | 3,063,923 | | | 3,468,487 | [removed: | | 3,256,705 |]
| Long-term debt, less current maturities | | | [added: 643,351 | | |] 1,164,133 | | | 1,258,861 | | | 269,988 | | | 1,078,611 | [removed: | | 873,332 |]
| Total stockholders’ equity | | $ | [removed: 2,497,027] [added: 2,885,679] | | $ | [removed: 2,072,193] [added: 2,497,027] | | $ | [removed: 2,058,980] [added: 2,072,193] | | $ | [removed: 1,960,266] [added: 2,058,980] | | $ | [removed: 1,694,831] [added: 1,960,266] |
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* Within our consolidated statements of income for the years ended June 30, 2020, 2019, 2018, 2017 and 2016, cost of sales has been adjusted to include amortization of acquired intangible assets directly applicable to revenue.
As a result, gross profit includes amortization of acquired intangible assets relating to cost of sales and operating expenses have been reduced by this amount.
There was no impact on income from operations, income before taxes or net income, as a result of this reclassification.
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Item 8. CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
448 rewritten, 136 added, 240 removed, 681 unchanged
| [Report of Independent Registered Public Accounting Firm](#AUDITORS_REPORT) | [removed: 51] [added: 57] |
| [Consolidated Balance Sheets as of June 30, [removed: 2020] [added: 2021] and [removed: 2019](#BALANCE_SHEET)] [added: 2020](#BALANCE_SHEET)] | [removed: 53] [added: 59] |
| [Consolidated Statements of Income for the years ended June 30, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018](#INCOME_STATEMENT)] [added: 2019](#INCOME_STATEMENT)] | [removed: 54] [added: 60] |
| [Consolidated Statements of Comprehensive Income for the years ended June 30, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018](#COMPREHENSIVE_INCOME)] [added: 2019](#COMPREHENSIVE_INCOME)] | [removed: 55] [added: 61] |
| [Consolidated Statements of Stockholders’ Equity for the years ended June 30, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018](#EQUITY_STATEMENT)] [added: 2019](#EQUITY_STATEMENT)] | [removed: 56] [added: 62] |
| [Consolidated Statements of Cash Flows for the years ended June 30, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018](#CASH_FLOWS)] [added: 2019](#CASH_FLOWS)] | [removed: 57] [added: 63] |
| [Notes to Consolidated Financial Statements](#NOTES_TO_FINANCIAL_STATEMENTS) | [removed: 58] [added: 64] |
| [Schedule II – Valuation and Qualifying Accounts and Reserves](#SCHEDULE_II) | [removed: 81] [added: 85] |
Quarterly Financial Information (unaudited)—The quarterly results for the years ended June 30, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] are summarized below (in thousands, except per share amounts):
| Gross [removed: profit*] [added: profit] | | | 391,619 | | | 427,130 | | | 449,662 | | | 449,372 | | | 1,717,786 |
| [removed: 2019] [added: 2021] | | FirstQuarter | | | SecondQuarter | | | ThirdQuarter | | | FourthQuarter | | | FiscalYear | |
| Basic earnings per share | | [removed: | 0.74 | | | 0.87 | |] [added: $] | [removed: 0.74] [added: 3.27] | | [added: $] | [removed: 0.48] [added: 4.31] | | [added: $] | 2.83 |
| Diluted earnings per share | | [removed: | 0.73 | | | 0.86 | |] [added: $] | [removed: 0.73] [added: 3.24] | | [added: $] | [removed: 0.48] [added: 4.27] | | [added: $] | 2.80 |
We have audited the accompanying consolidated balance sheets of ResMed Inc. and subsidiaries (the Company) as of June 30, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] the related consolidated statements of income, comprehensive income, stockholders’ equity, and cash flows for each of the years in the [removed: three year] [added: three-year] period ended June 30, [removed: 2020,] [added: 2021,] and the related notes and financial statement schedule II (collectively, the consolidated financial statements).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of June 30, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the results of its operations and its cash flows for each of the years in the [removed: three year] [added: three-year] period ended June 30, [removed: 2020,] [added: 2021,] in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of June 30, [removed: 2020,] [added: 2021,] based on criteria established in [removed: *Internal] [added: Internal] Control – Integrated Framework [removed: (2013)*] [added: (2013)] issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated August [removed: 12, 2020] [added: 16, 2021] expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
[removed: As discussed in Note 3 to the consolidated financial statements, the] [added: The] Company [added: has] changed its method of accounting for leases [removed: beginning] [added: as of] July 1, 2019 due to the adoption of the FASB’s Accounting Standards Codification Topic 842, *Leases*.
*Critical Audit [removed: Matters*][added: Matter*]
The critical audit [removed: matters] [added: matter] communicated below [removed: are matters] [added: is a matter] arising from the current period audit of the consolidated financial statements that [removed: were] [added: was] communicated or required to be communicated to the audit committee and that: (1) [removed: relate] [added: relates] to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
The communication of [added: a] critical audit [removed: matters] [added: matter] does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit [removed: matters] [added: matter] below, providing [added: a] separate [removed: opinions] [added: opinion] on the critical audit [removed: matters] [added: matter] or on the accounts or disclosures to which [removed: they relate.][added: it relates.]
We evaluated the design and tested the operating effectiveness of [added: certain] internal controls related to the [removed: critical audit matter.][added: uncertain tax position related to the ATO audits, including the gross unrecognized tax benefits and related tax credits and deductions.]
*Evaluation of [added: the] uncertain tax [removed: positions] [added: position] related to Australian Tax Office audits*
As discussed in Note 14 to the consolidated financial statements, the Company’s tax filings in Australia for the years 2009 through [removed: 2017] [added: 2018 (the Audit Period)] are under audit by the Australian Tax Office (ATO).
[removed: However, the Company has not recorded any expense relating to the ongoing audit, or these assessments, as the] [added: The] Company believes it is more likely than not [removed: (more] [added: (greater] than a 50% likelihood) that its tax [removed: positions will] [added: position would] be [removed: upheld.][added: upheld in litigation.]
We identified the evaluation of [added: the] uncertain tax [removed: positions] [added: position and] related [added: tax credits and deductions related] to [removed: Australian Tax Office] [added: the ATO] audits as a critical audit matter.
This critical audit matter required challenging auditor judgment due to the nature and the [removed: subjectivity] [added: complexity] of the applicable tax [removed: rules] [added: laws] and [removed: regulations.][added: regulations and involved tax professionals with specialized skills and knowledge.]
We involved tax professionals with specialized skills and [removed: knowledge of Australian tax laws,] [added: knowledge,] who assisted in:
[removed: Reading formal notices and] [added: reading notices,] assessments, and other correspondence [removed: received by] [added: between] the Company [removed: from] [added: and] the ATO in connection with the [removed: audit, as well as responses and information the Company submitted to the ATO in response to its requests for information;][added: Audit Period]
[removed: Evaluating] [added: evaluating] the Company’s analysis [removed: and conclusions regarding its assertion, which included an assessment] of the [removed: Company’s analysis of Australian] [added: applicable] tax laws [removed: and regulations related to the specific audit findings, and an evaluation of] [added: with] the facts, assumptions, and representations [removed: made; and][added: made by the Company]
June 30, [added: 2021,] 2020 and 2019
| | [added: |] June [removed: 30,2020] [added: 30, 2021] | | | June [removed: 30,2019] [added: 30, 2020] | | [added: | June 30, 2019 | |]
| Cash and cash equivalents [added: at beginning of period] | [removed: $] | [added: |] 463,156 | | [removed: $] | 147,128 | [added: | | 188,701 |]
| Accounts receivable, net of [removed: allowance for doubtful accounts] [added: allowances] of [removed: $28,508] [added: $32,138] and [removed: $25,171] [added: $28,508] at June 30, [removed: 2020] [added: 2021] and June 30, [removed: 2019,] [added: 2020,] respectively | | [removed: 474,643] [added: 614,292] | | | [removed: 528,484] [added: 474,643] |
| Inventories (note 4) | | [removed: 416,915] [added: 457,033] | | | [removed: 349,641] [added: 416,915] |
| Prepaid expenses and other current assets | | [removed: 168,745] [added: 135,745] | | | [removed: 120,113] [added: 75,261] |
| Total current assets | | [removed: 1,523,459] [added: 1,574,757] | | | [removed: 1,145,366] [added: 1,523,459] |
| Property, plant and equipment, net (note 4) | | [removed: 417,335] [added: 463,490] | | | [removed: 387,460] [added: 417,335] |
| Operating lease right-of-use assets (note 10) | | [removed: 118,348] [added: 128,575] | | | [removed: \-] [added: 118,348] |
| Goodwill (note 5) | | [removed: 1,890,324] [added: 1,927,901] | | | [removed: 1,856,449] [added: 1,890,324] |
| Other intangible assets, net (note 5) | | [removed: 448,168] [added: 392,582] | | | [removed: 521,950] [added: 448,168] |
| Net revenue | | $ | 751,944 | | $ | 800,011 | | $ | 768,767 | | $ | 876,103 | | $ | 3,196,825 |
| Gross profit | | | 438,661 | | | 462,483 | | | 447,258 | | | 490,696 | | | 1,839,100 |
| Net income (loss) | | | 178,372 | | | 179,514 | | | (78,481) | | | 195,098 | | | 474,505 |
| Basic earnings (loss) per share | | | 1.23 | | | 1.24 | | | (0.54) | | | 1.34 | | | 3.27 |
| Diluted earnings (loss) per share | | | 1.22 | | | 1.23 | | | (0.54) | | | 1.33 | | | 3.24 |
However, the Company is engaged
in advanced discussions with the ATO to settle the dispute for the entire Audit Period and has recorded $395.3 million of gross unrecognized tax benefits, adjusted for tax credits and deductions of $146.6 million.
recalculating the Company’s determination of the gross unrecognized tax benefits and the related tax credits and deductions
inquiring of third-party legal and tax advisors about the Company’s determination to adjust the gross unrecognized tax benefit related to the ATO audits for certain tax credits and deductions.
/s/ KPMG LLP
August 16, 2021
| | June 30,2021 | | | June 30,2020 | |
| Cash and cash equivalents | $ | 295,278 | | $ | 463,156 |
| Prepaid taxes | | 72,409 | | | 93,484 |
Years ended June 30, 2021, 2020 and 2019
| Net income | \- | | \- | | \- | \- | | \- | | 474,505 | | \- | | 474,505 |
| Cumulative effect adjustment from adoption of the credit loss standard, net of tax | \- | | \- | | \- | \- | | \- | | (1,143) | | \- | | (1,143) |
| Dividends declared | \- | | \- | | \- | \- | | \- | | (226,713) | | \- | | (226,713) |
| Balance, June 30, 2021 | 187,485 | $ | 583 | $ | 1,622,199 | (41,836) | $ | (1,623,256) | $ | 3,079,640 | $ | (193,487) | $ | 2,885,679 |
Years ended June 30, 2021, 2020 and 2019
| Net income | | $ | 474,505 | | $ | 621,674 | | $ | 404,592 |
| Stock-based compensation costs (note 11) | | | 63,927 | | | 57,559 | | | 52,073 |
In addition, we measure investments in publicly held equity securities and privately held equity securities for which there has been an observable price change in an identical or similar security, at fair value.
We have equity investments in privately and publicly held companies that are unconsolidated entities.
The following discusses our accounting for investments in marketable equity securities, non-marketable equity securities, and investments accounted for under the equity method.
Our marketable equity securities are publicly traded stocks measured at fair value and classified within Level 1 in the fair value hierarchy because we use quoted prices for identical assets in active markets.
Marketable equity securities are recorded in prepaid expenses and other current assets on the consolidated balance sheets.
We assess non-marketable equity securities at least quarterly for impairment and consider qualitative and quantitative factors including the investee's financial metrics, product and commercial outlook and cash usage.
All gains and losses on marketable and non-marketable equity securities, realized and unrealized, are recognized in other, net on the consolidated statements of operations.
(p) Allowance for Credit Losses
We maintain an allowance for credit losses on customer receivables based on our historical write-off experience, an assessment of our customers’ financial conditions and available information that is relevant to assessing the collectability of cash flows, which includes current conditions and forecasts about future economic conditions.
Refer to Note 3(b) below for information regarding our adoption of the credit loss standard effective July 1, 2020.
We will evaluate transactions or contract modifications occurring as a result of reference rate reform and determine whether to apply the optional guidance on an ongoing basis.
The guidance was adopted effective July 1, 2020 using the modified retrospective approach.
We recognized the cumulative effect of adopting this guidance as an adjustment to the opening balance of retained earnings of $1.1 million, net of tax, related to our allowance for credit losses for accounts receivable.
The guidance was adopted effective July 1, 2020 and applied prospectively.
| | | 2021 | | | | | | | |
| Business acquisitions | | | 5,829 | | | 18,842 | | | 24,671 |
| Balance at the end of the period | | $ | 633,183 | | $ | 1,294,718 | | $ | 1,927,901 |
| Estimated amortization expense | | $ | 75,009 | | $ | 58,028 | | $ | 54,211 | | $ | 49,741 | | $ | 44,556 |
| --- | --- |
| Net revenue | | $ | 588,279 | | $ | 651,100 | | $ | 662,228 | | $ | 704,964 | | $ | 2,606,572 |
| Gross profit* | | | 336,138 | | | 374,532 | | | 380,970 | | | 402,432 | | | 1,494,071 |
| Net income | | | 105,737 | | | 124,639 | | | 105,416 | | | 68,797 | | | 404,592 |
*Within our consolidated statements of income for the years ended June 30, 2020 and 2019, cost of sales has been adjusted to include amortization of acquired intangible assets directly applicable to revenue.
As a result, gross profit includes amortization of acquired intangible assets relating to cost of sales and operating expenses have been reduced by this amount.
There was no impact on income from operations, income before taxes or net income, as a result of this reclassification
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##### [Table of Contents](#TOC)
| PART II | Item 8 |
RESMED INC. AND SUBSIDIARIES
*Evaluation of goodwill triggering events*
As discussed in Notes 1(i) and 5 to the consolidated financial statements, the carrying amount of goodwill as of June 30, 2020 was $1,890 million.
The Company performs goodwill impairment testing on an annual basis and whenever events or changes in circumstances indicate that the carrying value of a reporting unit, including goodwill, might exceed the fair value of the reporting unit.
In the current year, the Company performed qualitative,
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or Step 0, assessments to determine whether there was a greater than 50 percent likelihood that the fair value of each reporting unit was less than its carrying value.
We identified the evaluation of goodwill triggering events as a critical audit matter because such events indicate possible impairment of goodwill, which required the application of greater auditor judgment.
Potential triggering events, such as macroeconomic conditions, industry and market considerations, cost factors, overall financial performance, market capitalization and events specific to the entity and reporting units, required a higher degree of auditor judgment to evaluate.
These possible triggering events could have a significant effect on the Company’s Step 0 assessment and the determination of whether further quantitative analysis of goodwill impairment was required.
The following are the primary procedures we performed to address this critical audit matter.
This included a control related to the Company’s assessment of possible goodwill triggering events.
We evaluated the Company’s Step 0 assessment for its reporting units by:
Considering macroeconomic indicators such as gross domestic product and inflation by key regions around the world;
Evaluating information from analyst reports in the enterprise software and sleep and respiratory care industries, which are compared to industry and market considerations used by the Company; and
Analyzing information including changes in the costs of raw materials and labor, the financial performance of the reporting units, the Company’s market capitalization, and other entity and reporting-unit specific events.
The Company has been assessed $266 million of additional income tax, penalties, and interest for tax years 2009 through 2013 in connection with this tax audit.
Certain of these amounts have been paid by the Company to the ATO.
We evaluated the design and tested the operating effectiveness of certain internal controls related to the critical audit matter.
This included controls over the Australian tax calculation and assessment of uncertain tax positions.
Reading legal opinions obtained by the Company from third parties, and inquiring of third-party legal counsel about the likelihood of the Company’s tax position being ultimately upheld.

August 12, 2020
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| | | | | | |
| --- | --- | --- | --- | --- | --- |
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| Balance, June 30, 2017 | 183,261 | $ | 569 | $ | 1,379,130 | (41,086) | $ | (1,546,611) | $ | 2,316,237 | $ | (189,059) | $ | 1,960,266 |
An excerpt. Shown here: 40 of 448 rewritten, 40 of 136 added and 40 of 240 removed. The counts are complete. For every sentence, read Item 8. CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA in the FY2021 filing and the FY2020 filing.
Item 9A. CONTROLS AND PROCEDURES
9 rewritten, 5 added, 10 removed, 45 unchanged
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of June 30, [removed: 2020.][added: 2021.]
Based on the foregoing, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of June 30, [removed: 2020.][added: 2021.]
Management assessed the effectiveness of our internal control over financial reporting as of June 30, [removed: 2020.][added: 2021.]
Based on that assessment under the framework in Internal Control-Integrated Framework (2013), management concluded that the company’s internal control over financial reporting was effective as of June 30, [removed: 2020.][added: 2021.]
KPMG LLP, independent registered public accounting firm, who audited and reported on the consolidated financial statements of [removed: ResMed,] [added: ResMed] Inc. included in this report, has issued an attestation report on the effectiveness of internal control over financial reporting.
We have audited ResMed Inc. and [removed: subsidiaries’] [added: subsidiaries'] (the Company) internal control over financial reporting as of June 30, [removed: 2020,] [added: 2021,] based on criteria established in [removed: *Internal] [added: Internal] Control – Integrated Framework [removed: (2013)*] [added: (2013)] issued by the Committee of Sponsoring Organizations of the Treadway Commission.
In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of June 30, [removed: 2020,] [added: 2021,] based on criteria established in [removed: *Internal] [added: Internal] Control – Integrated Framework [removed: (2013)*] [added: (2013)] issued by the Committee of Sponsoring Organizations of the Treadway Commission.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of June 30, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] the related consolidated statements of income, comprehensive income, stockholders’ equity, and cash flows for each of the years in the three-year period ended June 30, [removed: 2020,] [added: 2021,] and the related notes and financial statement schedule II (collectively, the consolidated financial statements), and our report dated August [removed: 12, 2020] [added: 16, 2021] expressed an unqualified opinion on those consolidated financial statements.
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying [removed: *Management’s] [added: Management’s] Report on Internal Control Over Financial [removed: Reporting*.][added: Reporting.]
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/s/ KPMG LLP
August 16, 2021
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##### [Table of Contents](#TOC)
| PART II | Items 9 – 9B |
| --- | --- |
RESMED INC. AND SUBSIDIARIES
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August 12, 2020
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Item 9B. OTHER INFORMATION
0 rewritten, 1 added, 1 removed, 6 unchanged
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Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
2 rewritten, 0 added, 0 removed, 0 unchanged
Information required by this Item is incorporated by reference from our definitive proxy statement for our next annual meeting of stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, [removed: 2020.][added: 2021.]
We have filed as exhibits to this report for the year ended June 30, [removed: 2020,] [added: 2021,] the certifications of our chief executive officer and chief financial officer required by Section 302 of the Sarbanes-Oxley Act of 2002.
Item 11. EXECUTIVE COMPENSATION
1 rewritten, 0 added, 0 removed, 0 unchanged
Information required by this Item is incorporated by reference from our definitive proxy statement for our next annual meeting of stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, [removed: 2020.][added: 2021.]
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
1 rewritten, 0 added, 0 removed, 0 unchanged
Information required by this Item is incorporated by reference from our definitive proxy statement for our next annual meeting of stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, [removed: 2020.][added: 2021.]
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
1 rewritten, 0 added, 0 removed, 0 unchanged
Information required by this Item is incorporated by reference from our definitive proxy statement for our next annual meeting of stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, [removed: 2020.][added: 2021.]
Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
1 rewritten, 1 added, 1 removed, 5 unchanged
Information required by this Item is incorporated by reference from our definitive proxy statement for our next annual meeting of stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, [removed: 2020.][added: 2021.]
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Item 15. EXHIBITS AND CONSOLIDATED FINANCIAL STATEMENT SCHEDULES
25 rewritten, 2 added, 10 removed, 17 unchanged
| 2.1 | [Agreement and Plan of Merger, dated November 5, 2018, by and among ResMed Operations Inc., Evolved Sub, Inc., ResMed Inc., OPEL GI Holdings Limited, in its capacity as the agent acting on behalf of the holders of common stock of MatrixCare Holdings, Inc., and MatrixCare Holdings, [removed: Inc.](http://www.sec.gov/Archives/edgar/data/943819/000119312518322531/d650415dex21.htm)] [added: Inc.](https://www.sec.gov/Archives/edgar/data/943819/000119312518322531/d650415dex21.htm)] (Incorporated by reference to Exhibit 2.1 to the Registrant’s Report on Form 8-K filed on November 8, 2018) |
| 4.2 | [Description of ResMed Inc.’s securities registered pursuant to Section 12 of the Securities Exchange Act of 1934](https://www.sec.gov/Archives/edgar/data/943819/000094381920000013/rmd-20200630xex4_2.htm) [added: (Incorporated by reference to Exhibit 4.2 to the Registrant’s Report on Form 10-K filed on August 13, 2020)] |
| 10.2* | [removed: [ResMed Inc. 2006 Incentive Award Plan.](http://www.sec.gov/Archives/edgar/data/943819/000119312506236282/dex991.htm)] [added: [Form of Access Agreement for directors.](http://www.sec.gov/Archives/edgar/data/943819/000119312509136727/dex102.htm)] (Incorporated by reference to Exhibit [removed: 99.1] [added: 10.2] to the Registrant’s Report on Form 8-K filed on [removed: November 15, 2006)] [added: June 24, 2009)] |
| [removed: 10.3*] [added: 10.8*] | [removed: [Amendment No. 1 to the ResMed Inc. 2006 Incentive Award Plan.](http://www.sec.gov/Archives/edgar/data/943819/000119312507022934/dex1024.htm)] [added: [Form of Stock Option Grant for Executive Officers.](http://www.sec.gov/Archives/edgar/data/943819/000119312511293193/d239703dex103.htm)] (Incorporated by reference to Exhibit [removed: 10.24] [added: 10.3] to the Registrant’s Report on Form 10-Q for the quarter ended [removed: December 31, 2006,] [added: September 30, 2011,] filed on [removed: February 8, 2007)] [added: November 3, 2011)] |
| [removed: 10.4*] [added: 10.9*] | [removed: [2006] [added: [Form of Stock Option] Grant [removed: agreement] for [removed: Board of Directors.](http://www.sec.gov/Archives/edgar/data/943819/000119312507022934/dex1025.htm)] [added: Directors.](http://www.sec.gov/Archives/edgar/data/943819/000119312511293193/d239703dex104.htm)] (Incorporated by reference to Exhibit [removed: 10.25] [added: 10.4] to the Registrant’s Report on Form 10-Q for the quarter ended [removed: December 31, 2006] [added: September 30, 2011,] filed on [removed: February 8, 2007)] [added: November 3, 2011)] |
| [removed: 10.5*] [added: 10.6*] | [removed: [2006 Grant agreement] [added: [Form of Restricted Stock Unit Award Agreement] for Executive [removed: Officers.](http://www.sec.gov/Archives/edgar/data/943819/000119312507190078/dex1026.htm)] [added: Officers.](http://www.sec.gov/Archives/edgar/data/943819/000119312511293193/d239703dex101.htm)] (Incorporated by reference to Exhibit [removed: 10.26] [added: 10.1] to the Registrant’s Report on Form [removed: 10-K] [added: 10-Q] for the [removed: year] [added: quarter] ended [removed: June] [added: September] 30, [removed: 2007,] [added: 2011,] filed on [removed: August 28, 2007)] [added: November 3, 2011)] |
| [removed: 10.6*] [added: 10.1*] | [removed: [2006 Grant agreement] [added: [Form of Indemnification Agreements] for [removed: Australian Executive Officers.](http://www.sec.gov/Archives/edgar/data/943819/000119312507190078/dex1027.htm)] [added: our directors and officers.](http://www.sec.gov/Archives/edgar/data/943819/000119312509136727/dex101.htm)] (Incorporated by reference to Exhibit [removed: 10.27] [added: 10.1] to the Registrant’s Report on Form [removed: 10-K for the year ended June 30, 2007,] [added: 8-K] filed on [removed: August 28, 2007)] [added: June 24, 2009)] |
| [removed: 10.7*] [added: 10.3*] | [removed: [Form] [added: [Updated Form] of Executive [removed: Agreement.](http://www.sec.gov/Archives/edgar/data/943819/000119312507155010/dex991.htm)] [added: Agreement.](http://www.sec.gov/Archives/edgar/data/943819/000119312512292369/d373159dex991.htm)] (Incorporated by reference to Exhibit 99.1 to the Registrant’s Report on Form 8-K filed on July [removed: 13, 2007)] [added: 2, 2012)] |
| [removed: 10.10] [added: 10.7*] | [Form of [removed: Access] [added: Restricted Stock Unit Award] Agreement for [removed: directors.](http://www.sec.gov/Archives/edgar/data/943819/000119312509136727/dex102.htm)] [added: Directors.](http://www.sec.gov/Archives/edgar/data/943819/000119312511293193/d239703dex102.htm)] (Incorporated by reference to Exhibit 10.2 [added: to] the Registrant’s Report on Form [removed: 8-K] [added: 10-Q for the quarter ended September 30, 2011,] filed on [removed: June 24, 2009)] [added: November 3, 2011)] |
| [removed: 10.12] [added: 10.4*] | [Amendment and Restatement to the ResMed Inc. 2009 Incentive Award Plan.](https://www.sec.gov/Archives/edgar/data/943819/000119312517293062/d456787ddef14a.htm) (Incorporated by reference to Appendix B of ResMed Inc.’s Proxy Statement filed with the Securities and Exchange Commission on September 25, [removed: 2017.)] [added: 2017)] |
| [removed: 10.13] [added: 10.5*] | [ResMed Inc. [removed: 2009 Incentive Award Plan](http://www.sec.gov/Archives/edgar/data/943819/000119312509240374/dex101.htm).] [added: Deferred Compensation Plan.](https://www.sec.gov/Archives/edgar/data/943819/000094381921000014/rmd-20210521xex4_4.htm)] (Incorporated by reference to Exhibit [removed: 10.1] [added: 4.4 to] the Registrant’s Report on Form [removed: 8-K] [added: S-8] filed on [removed: November 23, 2009)] [added: May 21, 2021)] |
| [removed: 10.19] [added: 10.10*] | [Form of Performance-Based Restricted Stock Unit Award Agreement for Executive [removed: Officers.](http://www.sec.gov/Archives/edgar/data/943819/000119312512478715/d442943d8k.htm) (Incorporated by reference to Appendix A of the Registrant’s Proxy Statement filed October 4, 2012)] [added: Officers.](https://www.sec.gov/Archives/edgar/data/943819/000094381921000017/rmd-20210630xex10_10.htm)] |
| [removed: 10.20] [added: 10.12] | [Amended and Restated Credit Agreement dated as of April 17, 2018, by and among ResMed Inc., as borrower, each of the lenders identified on the Revolving Credit Agreement’s signature pages as a lender, MUFG Union Bank, N.A., as administrative agent, joint lead arranger, joint book runner, swing line lender and l/c issuer, and Westpac Banking Corporation, as syndication agent, joint lead arranger and joint book runner.](http://www.sec.gov/Archives/edgar/data/943819/000119312518122818/d572927dex101.htm) (Incorporated by reference to Exhibit 10.1 to the Registrant’s Report on Form 8-K filed on April 19, 2018) |
| [removed: 10.21] [added: 10.13] | [Amended and Restated Unconditional Guaranty dated as of April 17, 2018, by each of the guarantors identified on the Revolving Facility Guaranty’s signature pages as a guarantor, in favor of MUFG Union Bank, N.A., in its capacity as administrative agent under the Revolving Credit Agreement.](http://www.sec.gov/Archives/edgar/data/943819/000119312518122818/d572927dex102.htm) (Incorporated by reference to Exhibit 10.2 to the Registrant’s Report on Form 8-K filed on April 19, 2018) |
| [removed: 10.22] [added: 10.14] | [Syndicated Facility Agreement, dated as of April 17, 2018, by and among ResMed Limited, as borrower, the other parties party thereto, each of the lenders identified on the Term Credit Agreement’s signature pages as a lender, MUFG Union Bank, N.A., as administrative agent, joint lead arranger and joint book runner, and Westpac Banking Corporation, as syndication agent, joint lead arranger and joint book runner](http://www.sec.gov/Archives/edgar/data/943819/000119312518122818/d572927dex103.htm). (Incorporated by reference to Exhibit 10.3 to the Registrant’s Report on Form 8-K filed on April 19, 2018) |
| [removed: 10.23] [added: 10.15] | [Unconditional Guaranty dated as of April 17, 2018, by each of the guarantors identified on the Term Facility Guaranty’s signature pages as a guarantor, in favor of MUFG Union Bank, N.A., in its capacity as administrative agent under the Term Credit Agreement](http://www.sec.gov/Archives/edgar/data/943819/000119312518122818/d572927dex104.htm). (Incorporated by reference to Exhibit 10.4 to the Registrant’s Report on Form 8-K filed on April 19, 2018) |
| [removed: 10.24] [added: 10.16] | [First Amendment to Amended and Restated Credit Agreement, dated November 5, 2018, by and among ResMed Inc., as borrower, each of the lenders identified in the First Amendment, MUFG Union Bank, N.A., as administrative agent, joint lead arranger, joint book runner, swing line lender and letter of credit issuer, and Westpac Banking Corporation, as syndication agent, joint lead arranger and joint book runner.](http://www.sec.gov/Archives/edgar/data/943819/000119312518322531/d650415dex101.htm) (Incorporated by reference to Exhibit 10.1 to the Registrant’s Report on Form 8-K filed on November 8, 2018) |
| [removed: 10.25] [added: 10.17] | [The ResMed Inc. 2018 Employee Stock Purchase Plan](https://www.sec.gov/Archives/edgar/data/943819/000119312518291742/d612931ddef14a.htm). (Incorporated by reference to Appendix B of ResMed Inc.’s Proxy Statement filed with the Securities and Exchange Commission on October 3, 2018.) |
| [removed: 10.26] [added: 10.18] | [Note Purchase Agreement, dated July 10, 2019 [added: by and] among ResMed Inc. and the purchasers party to that agreement (including form of 3.24% Series A Senior Note due 2026, form of Series B 3.45% Senior Note due 2029, and form of Subsidiary Guaranty Agreement).](https://www.sec.gov/Archives/edgar/data/943819/000119312519194005/d755232dex101.htm) (Incorporated by reference to Exhibit 10.1 to the Registrant’s Report on Form 8-K filed on July 15, 2019) |
| 21.1 | [Subsidiaries of the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/943819/000094381920000013/rmd-20200630xex21_1.htm)] [added: Registrant.](https://www.sec.gov/Archives/edgar/data/943819/000094381921000017/rmd-20210630xex21_1.htm)] |
| 23.1 | [Consent of Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/943819/000094381920000013/rmd-20200630xex23_1.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/943819/000094381921000017/rmd-20210630xex23_1.htm)] |
| 31.1 | [Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/943819/000094381920000013/rmd-20200630xex31_1.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/943819/000094381921000017/rmd-20210630xex31_1.htm)] |
| 31.2 | [Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/943819/000094381920000013/rmd-20200630xex31_2.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/943819/000094381921000017/rmd-20210630xex31_2.htm)] |
| 32.1 | [Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of [removed: 2002.](https://www.sec.gov/Archives/edgar/data/943819/000094381920000013/rmd-20200630xex32_1.htm)] [added: 2002.](https://www.sec.gov/Archives/edgar/data/943819/000094381921000017/rmd-20210630xex32_1.htm)] |
| 101 | The following materials from ResMed Inc.’s Annual Report on Form 10-K for the fiscal year ended June 30, [removed: 2020] [added: 2021] formatted in Extensible Business Reporting Language (XBRL): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Income, (iii) the Consolidated Statements of Stockholders’ Equity and Comprehensive Income, (iv) the Consolidated Statements of Cash Flows and (v) related notes. |
| 10.11* | [Form of Executive Restricted Stock Unit Award Agreement for Executive Officers.](https://www.sec.gov/Archives/edgar/data/943819/000094381921000017/rmd-20210630xex10_11.htm) |
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| 10.1 | Licensing Agreement between the University of Sydney and ResMed Ltd dated May 17, 1991, as amended. (Incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1 (No. 33-91094) declared effective on June 1, 1995) |
| 10.8* | [Amended and Restated 2006 Incentive Award Plan dated November 20, 2008.](http://www.sec.gov/Archives/edgar/data/943819/000119312508210835/ddef14a.htm) (Incorporated by reference to Appendix 1 of the Registrant’s Definitive Proxy Statement filed on October 15, 2008) |
| 10.9 | [Form of Indemnification Agreements for our directors and officers.](http://www.sec.gov/Archives/edgar/data/943819/000119312509136727/dex101.htm) (Incorporated by reference to Exhibit 10.1 the Registrant’s Report on Form 8-K filed on June 24, 2009) |
| 10.11* | [Updated Form of Executive Agreement.](http://www.sec.gov/Archives/edgar/data/943819/000119312512292369/d373159dex991.htm) (Incorporated by reference to Exhibit 99.1 to the Registrant’s Report on Form 8-K filed on July 2, 2012) |
| 10.14 | [ResMed Inc. Deferred Compensation Plan.](http://www.sec.gov/Archives/edgar/data/943819/000095013010001188/dex101.htm) (Incorporated by reference to Exhibit 10.1 the Registrant’s Report on Form 8-K filed on May 28, 2010) |
| 10.15 | [Form of Restricted Stock Unit Award Agreement for Executive Officers.](http://www.sec.gov/Archives/edgar/data/943819/000119312511293193/d239703dex101.htm) (Incorporated by reference to Exhibit 10.1 to the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2011, filed on November 3, 2011) |
| 10.16 | [Form of Restricted Stock Unit Award Agreement for Directors.](http://www.sec.gov/Archives/edgar/data/943819/000119312511293193/d239703dex102.htm) (Incorporated by reference to Exhibit 10.2 to the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2011, filed on November 3, 2011) |
| 10.17 | [Form of Stock Option Grant for Executive Officers.](http://www.sec.gov/Archives/edgar/data/943819/000119312511293193/d239703dex103.htm) (Incorporated by reference to Exhibit 10.3 to the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2011, filed on November 3, 2011) |
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| 10.18 | [Form of Stock Option Grant for Directors.](http://www.sec.gov/Archives/edgar/data/943819/000119312511293193/d239703dex104.htm) (Incorporated by reference to Exhibit 10.4 to the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2011, filed on November 3, 2011) |
Item 16. FORM 10-K SUMMARY
10 rewritten, 3 added, 2 removed, 35 unchanged
DATED August [removed: 12, 2020][added: 16, 2021]
| /S/ MICHAEL J. FARRELL | | Chief executive officer and director | | August [removed: 12, 2020] [added: 16, 2021] |
| /S/ BRETT A. SANDERCOCK | | Chief financial officer | | August [removed: 12, 2020] [added: 16, 2021] |
| /S/ PETER C. FARRELL | | Non-executive chairman | | August [removed: 12, 2020] [added: 16, 2021] |
| /S/ CAROL J. BURT | | Director | | August [removed: 12, 2020] [added: 16, 2021] |
| /S/ JAN De WITTE | | Director | | August [removed: 12, 2020] [added: 16, 2021] |
| /S/ RICHARD SULPIZIO | | Director | | August [removed: 12, 2020] [added: 16, 2021] |
| /S/ RON TAYLOR | | Director | | August [removed: 12, 2020] [added: 16, 2021] |
| /S/ KAREN DREXLER | | Director | | August [removed: 12, 2020] [added: 16, 2021] |
| /S/ HARJIT GILL | | Director | | August [removed: 12, 2020] [added: 16, 2021] |
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| | | | | |
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