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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended June 30, 2015
Commission file number: 001-15317
R ES M ED INC.
(Exact name of registrant as specified in its charter)
DELAWARE
(State or other jurisdiction of incorporation or organization)
98-0152841
(IRS Employer Identification No.)
9001 Spectrum Center Blvd.
San Diego, CA 92123
United States of America
(Address of principal executive offices)
(858) 836-5000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
TITLE OF EACH CLASS
Common Stock, $0.004 Par Value
Name of each exchange upon which registered
New York Stock Exchange
Securities registered pursuant to Section 12(g) of the Act
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [ x ] No [ ]
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes [ ] No [ x ]
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the
past 90 days. Yes [ x ] No [ ]
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes [ x ] No [ ]
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulations S-K (§ 229.405 of this Chapter) is not contained herein, and will not
be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the
definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer [ x ] Accelerated filer [ ] Non-accelerated filer [ ] Smaller reporting company [ ]
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [ x ]
The aggregate market value of the voting and non-voting common equity held by non-affiliates of registrant as of December 31, 2014 (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
$7,803,275,736. All directors, executive officers, and 10% stockholders of registrant are considered affiliates.
At July 28, 2015, registrant had 140,516,403 shares of Common Stock, $0.004 par value, issued and outstanding. This number excludes 39,186,234 shares held by
the registrant as treasury shares.
Portions of the registrant’s definitive Proxy Statement to be delivered to stockholders in connection with the registrant’s 2015 Annual Meeting of Stockholders, to
be filed subsequent to the date hereof, are incorporated by reference into Part III of this report.
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C
ONTENT
S
Cautionary Note Regarding Forward Looking Statements
Part I
Item 1
Business
Item 1A Risk Factors
Item 1B Unresolved Staff Comments
Item 2
Properties
Item 3
Legal Proceedings
Item 4
Mine Safety Disclosures
Part II
Item 5
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Item 6
Selected Financial Data
Item 7
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7A Quantitative and Qualitative Disclosures About Market and Business Risks
Item 8
Consolidated Financial Statements and Supplementary Data
Item 9
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9A Controls and Procedures
Item 9B Other Information
Part III
Item 10
Directors, Executive Officers and Corporate Governance
Item 11
Executive Compensation
Item 12
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13
Certain Relationships and Related Transactions and Director Independence
Item 14
Principal Accounting Fees and Services
Part IV Item 15
Exhibits and Consolidated Financial Statement Schedules
Signatures
1
1
21
30
31
31
32
33
36
38
48
51
51
52
54
55
55
55
55
55
56
S-1
As used in this 10-K, the terms “we”, “us”, “our” and “the Company” refer to ResMed Inc., a Delaware corporation, and its subsidiaries, on a consolidated basis,
unless otherwise stated.
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PART I
Cautionary Note Regarding Forward-Looking Statements
This report contains certain forward-looking statements and information that are based on the beliefs of our management as well as estimates and
assumptions made by, and information currently available to our management. All statements other than statements regarding historical facts are
forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend,” “seek,” “will,” “will continue,” “estimate,” “plan,” “future” and
other similar expressions generally identify forward-looking statements, including, in particular, statements regarding the development and approval
of new products and product applications, market expansion, pending litigation, and the development of new markets for our products, such as
cardiovascular and stroke markets. These forward-looking statements are made under the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. You are cautioned not to place undue reliance on these forward-looking statements each of which applies only as of the date of
this report. Such forward-looking statements reflect the views of our management at the time such statements are made and are subject to a number
of risks, uncertainties, estimates and assumptions, including, without limitation, and in addition to those identified in the text surrounding such
statements, those identified in Item 1A “Risk Factors” and elsewhere in this report.
In addition, important factors to consider in evaluating such forward-looking statements include changes or developments in social, economic,
market, legal or regulatory circumstances, changes in our business or growth strategy or an inability to execute our strategy due to changes in our
industry or the economy generally, the emergence of new or growing competitors, the actions or omissions of third parties, including suppliers,
customers, competitors and governmental authorities, and various other factors subject to risks and uncertainties which could cause actual results to
materially differ from those projected or implied in the forward-looking statements. Should any one or more of these risks or uncertainties
materialize, or the underlying estimates or assumptions prove incorrect, actual results may vary significantly from those expressed in such forward-
looking statements, and there can be no assurance that the forward-looking statements contained in this report will in fact occur.
I TEM 1
B USINESS
General
We are a global leader in the development, manufacturing, distribution and marketing of medical products for the diagnosis, treatment and
management of respiratory disorders, with a focus on sleep-disordered breathing, or SDB. SDB includes obstructive sleep apnea, or OSA, and other
respiratory disorders that occur during sleep. When we were formed in 1989, our primary purpose was to commercialize a treatment for OSA. This
treatment, nasal Continuous Positive Airway Pressure, or CPAP, was the first successful noninvasive treatment for OSA. CPAP systems deliver
pressurized air, typically through a nasal mask, to prevent collapse of the upper airway during sleep.
Since the development of CPAP, we have developed a number of innovative products for SDB and other respiratory disorders including airflow
generators, diagnostic products, mask systems, headgear and other accessories. Our growth has been fuelled by geographic expansion, our research
and product development efforts, and an increasing awareness of SDB and respiratory conditions as a significant health concern among physicians
and patients around the world.
We employ approximately 4,340 people and sell our products in approximately 100 countries through a combination of wholly owned subsidiaries
and independent distributors.
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Our web site address is www.resmed.com. We make our periodic reports, together with any amendments, available on our web site, free of charge,
as soon as reasonably practicable after we electronically file or furnish the reports with the Securities and Exchange Commission, or SEC.
Information contained on the website is not part of or incorporated into this annual report.
Corporate History
ResMed Inc., a Delaware corporation, was formed in March 1994 as the ultimate holding company for our operating subsidiaries. On June 1, 1995,
we completed an initial public offering of common stock and on June 2, 1995 our common stock commenced trading on the NASDAQ National
Market. On September 30, 1999 we transferred our principal public listing to the New York Stock Exchange, or NYSE, trading under the ticker
symbol RMD. On November 25, 1999, we established a secondary listing of our common stock via Chess Depositary Instruments, or CDI’s, on the
Australian Stock Exchange (now known as the Australian Securities Exchange), or ASX, also under the symbol RMD. Ten CDI’s on the ASX
represent one share of our common stock on the NYSE.
Our Australian subsidiary, ResMed Holdings Limited, was originally organized in 1989 by Dr. Peter Farrell to acquire from Baxter Center for
Medical Research Pty Limited, or Baxter, the rights to certain technology relating to CPAP treatment as well as Baxter’s existing CPAP device
business. Baxter acquired the rights to the technology in 1987, and sold CPAP devices in Australia from 1988 until our acquisition of the business.
Since formation we have acquired a number of businesses including distributors, suppliers, developers of medical equipment and related
technologies.
Segment Information
We believe that, given the single market focus of our operations in the sleep and respiratory disorders sector of the medical device industry, and the
inter-dependence of its products, we operate in a single operating segment. See Note 15 – Segment Information of the Notes to Financial Statements
(Part II, Item 8) for financial information regarding segment reporting. Financial information about our revenues from and assets located in foreign
countries is also included in the Notes to our consolidated financial statements.
The Market
Sleep is a complex neurological process that includes two distinct states: rapid eye movement, or REM, sleep and non-rapid eye movement, or non-
REM, sleep. REM sleep, which is about 20-25% of total sleep experienced by adults, is characterized by a high level of brain activity, bursts of rapid
eye movement, increased heart and respiration rates, and paralysis of many muscles. Non-REM sleep is subdivided into four stages that generally
parallel sleep depth; stage 1 is the lightest and stage 4 is the deepest.
The upper airway has no rigid support and is held open by active contraction of upper airway muscles. Normally, during REM sleep and deeper
levels of non-REM sleep, upper airway muscles relax and the airway narrows. Individuals with narrow upper airways or poor muscle tone are prone
to temporary collapses of the upper airway during sleep, called apneas, and to near closures of the upper airway called hypopneas. These breathing
events result in a lowering of blood oxygen concentration, causing the central nervous system to react to the lack of oxygen or increased carbon
dioxide and signaling the body to respond. Typically, the individual subconsciously arouses from sleep, causing the throat muscles to contract,
opening the airway. After a few gasping breaths, blood oxygen levels increase and the individual can resume a deeper sleep until the cycle repeats
itself. Sufferers of OSA
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typically experience ten or more such cycles per hour. While these awakenings greatly impair the quality of sleep, the individual is not normally
aware of these disruptions. In addition, OSA has been recognized as a cause of hypertension and a significant co-morbidity for heart disease, stroke
and diabetes.
A 2013 update to a long-term epidemiology study estimated that 26% of adults age 30-70 have some form of obstructive sleep apnea. In the United
States alone, this represents approximately 46 million people. Despite the high prevalence of OSA, there is a general lack of awareness of OSA
among both the medical community and the general public. It is estimated that less than 20% of those with OSA have been diagnosed or treated.
Many healthcare professionals are often unable to diagnose OSA because they are unaware that such non-specific symptoms as excessive daytime
sleepiness, snoring, hypertension and irritability are characteristic of OSA.
While OSA has been diagnosed in a broad cross-section of the population, it is predominant among middle-aged men and those who are obese,
smoke, consume alcohol in excess or use muscle-relaxing and pain-killing drugs. A strong association has been discovered between OSA and a
number of cardiovascular diseases. Studies have shown that SDB is present in approximately 83% of patients with drug-resistant hypertension,
approximately 72% of patients with type 2 diabetes, approximately 77% of patients with obesity and approximately 76% of patients with congestive
heart failure.
Sleep-Disordered Breathing and Obstructive Sleep Apnea
Sleep-disordered breathing encompasses all disease processes that cause abnormal breathing patterns during sleep. Manifestations include OSA,
central sleep apnea, or CSA, and hypoventilation syndromes that occur during sleep. Hypoventilation syndromes are generally associated with
obesity, chronic obstructive lung disease and neuromuscular disease. OSA is the most common form of SDB.
Sleep fragmentation and the loss of the deeper levels of sleep caused by OSA can lead to excessive daytime sleepiness, reduced cognitive function,
including memory loss and lack of concentration, depression and irritability. OSA sufferers also experience an increase in heart rate and an elevation
of blood pressure during the cycle of apneas. Several studies indicate that the oxygen desaturation, increased heart rate and elevated blood pressure
caused by OSA may be associated with increased risk of cardiovascular morbidity and mortality due to angina, stroke and heart attack. Patients with
OSA have been shown to have impaired daytime performance in a variety of cognitive functions including problem solving, response speed and
visual motor coordination, and studies have linked OSA to increased occurrences of traffic and workplace accidents.
Generally, an individual seeking treatment for the symptoms of OSA is referred by a general practitioner to a sleep specialist for further evaluation.
The diagnosis of OSA typically requires monitoring the patient during sleep at either a sleep clinic or the patient’s home. During overnight testing,
respiratory parameters and sleep patterns may be monitored, along with other vital signs such as heart rate and blood oxygen levels. Simpler tests,
using devices such as our Apnealink, or our automatic positive airway pressure devices, monitor airflow during sleep, and use computer programs to
analyze airflow patterns. These tests allow sleep clinicians to detect any sleep disturbances such as apneas, hypopneas or subconscious awakenings.
There are many studies being conducted that provide new evidence that treating SDB and OSA can improve health, quality of life and also mitigate
the dangers of sleep apnea in occupational health and safety, especially in the transport industry. Evidence continues to mount supporting the role of
SDB therapy for disease prevention, improvement of quality of life and healthcare cost reduction.
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Existing Therapies
Before 1981, the primary treatment for OSA was a tracheotomy, a surgical procedure to create a hole in the patient’s windpipe. Alternative surgical
treatments have involved either uvulopalatopharyngoplasty, or UPPP, in which surgery is performed on the upper airway to remove excess tissue and
to streamline the shape of the airway or implanting a device to add support to the soft palate. UPPP alone has a poor success rate; however, when
performed in conjunction with multi-stage upper airway surgical procedures, a greater success rate has been claimed. These combined procedures,
performed by highly specialized surgeons, are expensive and involve prolonged and often painful recovery periods. Surgical treatments are not
considered first line therapy for OSA. Other alternative treatments available today include nasal surgery, mandibular advancement surgery, dental
appliances, palatal implants, somnoplasty and nasal devices. Alternative treatments reported to be under development include pharmaceutical
therapies and electrical stimulation of the nerves or muscles.
A variety of devices are marketed for the treatment of OSA. Most are only partially effective, but CPAP is a reliable treatment for all severities of
OSA and is considered first-line therapy. Use of mandibular advancement devices is increasing as a second-line option in patients unable to use
CPAP or those with mild OSA. These devices cause the mandible and tongue to be pulled forward and improve the dimensions of the upper airway.
CPAP is a non-invasive means of treating OSA. 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 States in the mid 1980’s. During CPAP treatment, a patient
sleeps with a nasal interface connected to a small portable airflow generator that delivers room air at a positive pressure. The patient breathes in air
from the flow generator and breathes out through an exhaust port in the interface. Continuous air pressure applied in this manner acts as a pneumatic
splint to keep the upper airway open and unobstructed. Interfaces include nasal masks and nasal pillows. Sometimes, when a patient leaks air through
their mouth, a full-face mask may need to be used, rather than a nasal interface.
CPAP is not a cure and therefore, must be used on a nightly basis as long as treatment is required. Patient compliance has been a major factor in the
efficacy of CPAP treatment. Early generations of CPAP units provided limited patient comfort and convenience. Patients experienced soreness from
the repeated use of nasal masks and had difficulty falling asleep with the CPAP device operating at the prescribed pressure. In more recent years,
product innovations to improve patient comfort and compliance have been developed. These include more comfortable patient interface systems;
delay timers that gradually raise air pressure allowing the patient to fall asleep more easily; bilevel air flow generators, including Variable Positive
Airway Pressure, or VPAP systems, which provide different air pressures for inhalation and exhalation; heated humidification systems to make the
airflow more comfortable; and autotitration devices that reduce the average pressure delivered during the night.
Business Strategy
We believe that the SDB market will continue to grow in the future due to a number of factors including increasing awareness of OSA, improved
understanding of the role of SDB treatment in the management of cardiac, neurologic, metabolic and related disorders, and an increase in home-
based diagnosis. Our strategy for expanding our business operations and capitalizing on the growth of the SDB market consists of the following key
elements:
Continue Product Development and Innovation. We are committed to ongoing innovation in developing products for the diagnosis and
treatment of SDB. We have been a leading innovator of products designed to treat SDB more effectively, increase patient comfort and encourage
compliance with prescribed therapy. For example, in 2012, we introduced Swift FX Bella mask, Pixi pediatric mask, Quattro FX for Her and the
EasyCare compliance management solution. In 2013, we
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introduced new products across both our mask and flow generator categories, including the VPAP COPD, Quattro Air, Swift FX Bella, Swift FX
Nano and ResMed’s SleepSeeker. In 2014, we introduced the AirFit™ P10 nasal pillows system, AirFit™ N10 nasal mask, AirFit™ F10 full-face
mask and the Astral™ platform, our new generation of life support ventilators. During fiscal year 2015, we released significant new products across
our flow generator categories, including the AirSense
, our cloud-based
remote monitoring and therapy management system, along with our Air Solutions platform that provides a suite of end-to-end healthcare informatics
solutions that address customer business processes from diagnosis to monitoring and patient management and billing. We believe that continued
product development and innovation are key factors to our ongoing success. Approximately 13% of our employees are devoted to research and
development activities. In fiscal year 2015, we invested $114.9 million, or approximately 7% of our net revenues, in research and development.
10 , and Lumis. In 2015, we also released the AirView
10, AirCurve
TM
TM
TM
Expand Geographic Presence. We market our products in more than 100 countries to sleep clinics, home healthcare dealers and third-party
payors. We intend to increase our sales and marketing efforts in our principal markets, as well as expand the depth of our presence in other
geographic regions.
Increase Public and Clinical Awareness. We intend to continue to expand our existing promotional activities to increase awareness of SDB and
our treatment alternatives. These promotional activities target both the population with predisposition to SDB and medical specialists, such as
cardiologists, neurologists and pulmonologists. In addition, we also target special interest groups, including the National Stroke Association, the
American Heart Association and the National Sleep Foundation. In concert with other industry participants, we sponsor educational programs
targeted at the primary care physician community, which should further enlighten both doctors and patients about the relationship between SDB or
OSA and co-morbidities such as cardiac disease, diabetes, hypertension and obesity. The programs should also support our efforts to inform the
community of the dangers of sleep apnea with regard to occupational health and safety, especially in the transport industry.
Expand into New Clinical Applications. We continually seek to identify new applications of our technology for significant unmet medical needs.
Studies have established a clinical association between OSA and both stroke and congestive heart failure, and have recognized SDB as a cause of
hypertension or high blood pressure. Research also indicates that SDB is independently associated with glucose intolerance and insulin resistance. In
addition, we maintain close working relationships with a number of prominent physicians to explore new medical applications for our products and
technology. In 2014, we received Food and Drug Administration, or FDA, clearance and launched a new product in the United States for the
treatment of respiratory insufficiency due to chronic obstructive pulmonary disease and neuromuscular diseases.
Leverage the Experience of our Management Team. Our senior management team has extensive experience in the medical device industry in
general, and in the field of SDB in particular. We intend to continue to leverage the experience and expertise of these individuals to maintain our
innovative approach to the development of products and increase awareness of the serious medical problems caused by SDB.
Products
Our portfolio of products includes airflow generators, diagnostic products, mask systems, headgear and other accessories.
Air Flow Generators
We produce CPAP, VPAP and AutoSet systems for the titration and treatment of SDB. The flow generator systems deliver positive airway pressure
through a patient interface, either a small nasal
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mask, nasal pillows system, or full-face mask. Our VPAP units deliver ultra-quiet, comfortable bilevel therapy. AutoSet systems are based on a
proprietary technology to monitor breathing and can also be used in the diagnosis, treatment and management of OSA.
During fiscal year 2011, we launched the Stellar 100 and 150 ventilation devices, which provide both invasive and non-invasive ventilation
applications for adult and pediatric patients. In 2014, we launched the Astral™, our new generation of portable, lightweight, and user-friendly life
support ventilators. During fiscal year 2015, we released significant new products across our flow generator categories, including the AirSense
TM
AirCurve
10 , and Lumis.
TM
10,
Flow generators in total accounted for approximately 58%, 54% and 54% of our net revenues in fiscal years 2015, 2014, and 2013, respectively.
The tables below provide a selection of products, as known by our trademarks, which have been released during the last five years.
C ONTINUOUS
P OSITIVE A IRWAY
P RESSURE P RODUCTS
S9 Escape
AirSense 10 Elite
AirSense 10 CPAP
V ARIABLE
P OSITIVE A IRWAY
P RESSURE P RODUCTS
S9 VPAP S
D ESCRIPTION
As the Standard CPAP model of the S9 Series, the S9 Escape features
Expiratory Pressure Relief (EPR) and other innovative features including
Climate Control and the enhanced Easy-Breathe motor. The device also
has an optional integrated humidifier (H5i).
An advanced fixed-pressure therapy device with an integrated humidifier.
It is designed to be intuitive and easy-to-use. The device also features
built-in wireless connectivity.
The AirSense 10 CPAP is a fixed-pressure therapy device. It also provides
compliance, AHI and leak data reporting. The device also features built-in
wireless connectivity.
D ESCRIPTION
Bilevel pressure support therapy device in ResMed’s sleek, compact S9
Series. Designed for
comfort and compliance with the Easy-Breath waveform in S-mode* and
pressures up to 25 cmH2O. The device also has an optional integrated
humidifier (H5i), ClimateLine heated tube and the small, lightweight
SlimLine tube.
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D ATE OF
C OMMERCIAL
I NTRODUCTION
September 2010
August 2014
August 2014
D ATE OF
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I NTRODUCTION
March 2011
Table of Contents
V ARIABLE
P OSITIVE A IRWAY
P RESSURE P RODUCTS
S9 VPAP ST
S9 VPAP Auto
S9 VPAP Adapt
S9 AutoSet CS
S9 Auto 25#
D ESCRIPTION
Bilevel pressure support therapy device with pressures up to 25 cmH2O
designed for comfort, effective therapy with the assurance of back up rate
up to 50 bpm. The device also has an optional integrated humidifier (H5i),
ClimateLine heated tube and the small, lightweight SlimLine tube.
Premium auto-adjusting device with the unique VAuto mode and Easy-
Breathe technology designed for patients requiring both higher pressures
and pressure relief. VAuto mode features enhanced AutoSet technology
with central sleep apnea (CSA) detection. The device may be used with an
optional integrated humidifier (H5i), ClimateLine heated tube and the
small, lightweight SlimLine tube
Adaptive Servo-Ventilator specifically designed to provide a rapid
response to periodic breathing for the treatment of central and/or mixed
apneas, providing ventilatory support when it is needed packaged in
ResMed’s sleek, compact S9 Series. The device also offers an optional
integrated humidifier (H5i), ClimateLine heated tube and the small,
lightweight SlimLine tube.
Adaptive Servo-Ventilator specifically designed to provide a rapid
response to Cheyne-Stokes breathing and periodic breathing associated
with Heart Failure for the treatment of central and/or mixed apneas,
providing ventilatory support when it is needed. Packaged in ResMed’s
sleek, compact S9 Series. The device also has an optional integrated
humidifier (H5i), ClimateLine heated tube and the small, lightweight
SlimLine tube.
Premium auto-adjusting device with the unique VAuto mode and Easy-
Breathe technology designed for patients requiring both higher pressures
and pressure relief. VAuto mode features enhanced AutoSet technology
with central sleep apnea (CSA) detection. The device may be used with an
optional integrated humidifier (H5i), ClimateLine heated tube and the
small, lightweight SlimLine tube
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D ATE OF
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I NTRODUCTION
March 2011
March 2011
March 2011
March 2011
March 2011
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V ARIABLE
P OSITIVE A IRWAY
P RESSURE P RODUCTS
S9 VPAP ST-A
S9 VPAP COPD
AirCurve 10 S
AirCurve 10 V Auto
AirCurve 10 ST
AirCurve 10 CS
D ESCRIPTION
Bilevel pressure support therapy device with pressures up to 30 cmH2O
designed for comfort, effective therapy with the assurance of back up rate
up to 50 bpm and alarms. The device also has an optional integrated
humidifier (H5i), ClimateLine heated tube and the small, lightweight
SlimLine tube.
D ATE OF
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March 2013
Bilevel pressure support up to pressure 30cmH O with both fixed and
adjustable alarms. This device has been specifically designed for COPD.
2
April 2013
A bilevel device ideal for patients who need extra pressure support or find
it difficult to adjust to therapy on a fixed pressure continuous positive
airway pressure device. Features built-in wireless connectivity and works
seamlessly with ResMed’s AirView™ patient monitoring software.
An auto-adjusting bilevel device for patients who need greater pressure
support to treat their obstructive sleep apnea. Features built-in wireless
connectivity and works seamlessly with ResMed’s AirView™ patient
monitoring software.
A bilevel device with backup rate that provides exceptional patient-
ventilator synchrony, reducing the work of breathing so patients remain
comfortable and well ventilated. Features built-in wireless connectivity
and works seamlessly with ResMed’s AirView™ patient monitoring
software.
An adaptive servo-ventilator specifically designed to treat patients
exhibiting central sleep apnea (CSA), mixed sleep apnea and periodic
breathing, with or without obstructive sleep apnea. The device also
features built-in wireless connectivity. Features built-in wireless
connectivity and works seamlessly with ResMed’s AirView™ patient
monitoring software.
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December 2014
December 2014
December 2014
December 2014
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A UTOMATIC P OSITIVE
A IRWAY P RESSURE
P RODUCTS
S9 Escape Auto
AirSense 10 Auto
V ENTILATION P RODUCTS
Stellar 100 and 150
Astral
Lumis 100 and 150
*
D ESCRIPTION
The S9 Escape Auto is the Standard APAP device packaged in ResMed’s
sleek, compact S9 Series. It features an intelligent algorithm with Easy-
Breathe expiratory pressure relief (EPR) and delivers whisper-quiet
therapy in a smooth waveform. The device also offers an optional
integrated humidifier (H5i), Climate Control with the ClimateLine heated
tube and the small, lightweight SlimLine tube.
A premium auto-adjusting therapy device featuring AutoRamp™ with
sleep onset detection, expiratory pressure relief (EPR™) and Easy-
Breathe technology. The device also features built-in wireless
connectivity.
D ESCRIPTION
Pressure support ventilators for invasive and non-invasive purposes so it
can be used from the hospital to the home.
Pressure support and volume ventilator for invasive and non-invasive
purposes so it can be used from the hospital to the home
Pressure support noninvasive ventilators that support a variety of therapy
modes, built-in wireless connectivity, integrated humidification and
intuitive simplicity.
D ATE OF
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September 2010
August 2014
D ATE OF
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March 2011
May 2014
April 2015
*
Sold outside United States only
Masks, Accessories, Motors and Diagnostic Products
Masks, accessories, motors and diagnostic products together accounted for approximately 42%, 46% and 46% of our net revenues in fiscal years
2015, 2014, and 2013, respectively.
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Mask Systems and Diagnostic Products
Mask systems are one of the most important elements of SDB treatment systems. Masks are a primary determinant of patient comfort and as such
may drive or impede patient compliance with therapy. We have been a consistent innovator in masks, improving patient comfort while minimizing
size and weight.
M ASK P RODUCTS
Quattro FX
Swift FX for Her
Mirage FX
Mirage FX for Her
Full Face mask offering unobtrusive fit
D ESCRIPTION
Fourth generation nasal pillows system offering a fully flexible design for
comfort and performance with female specific design features
Nasal mask offering auto adjusting forehead support and SoftEdge
headgear
Nasal mask offering auto adjusting forehead support and SoftEdge
headgear with female specific design features
Pixi Pediatric Mask
A pediatric mask designed for children 2 years and older
Quattro FX for Her
Full face mask offering unobtrusive fit with female specific design
features
Swift FX Bella
Quattro Air
Swift FX Nano
AirFit P10
AirFit F10
AirFit N10
Fourth generation nasal pillows system with an alternative headgear
design
Next Generation lightweight Full Face Mask with improved comfort
A compact nasal mask designed to deliver an excellent user experience,
without compromising on fit, comfort and ease of use.
A compact, lightweight nasal pillows system that has only three parts,
including a new soft and stable QuickFit™ headgear.
A compact, lightweight full-face mask that delivers comfort, stability, and
performance in a simple and elegant design.
A compact nasal mask that stands out with its comfort and visual freedom
in a user-friendly design.
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D ATE OF
C OMMERCIAL
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September 2010
September 2010
October 2010
April 2011
September 2011
October 2011
January 2012
June 2013
June 2013
January 2014
April 2014
April 2014
Table of Contents
We market sleep recorders for the diagnosis and titration of SDB in sleep clinics and hospitals. These diagnostic systems record relevant respiratory
and sleep data, which can be analyzed by a sleep specialist or physician who can then tailor an appropriate OSA treatment regimen for the patient.
D IAGNOSTIC P RODUCTS
D ESCRIPTION
Apnealink Air
A portable diagnostic device which measures oximetry, respiratory effort,
pulse, nasal flow and snoring. Works with EasyCare Online to provide
comprehensive diagnostic solution to clinicians.
D ATE OF
C OMMERCIAL
I NTRODUCTION
December 2013
Accessories and Other Products
To assist those professionals diagnosing or managing the treatment of patients there are data communications and control products such as EasyCare,
ResLink, ResControl, ResControl II, TxControl, ResScan and ResTraxx modules that facilitate the transfer of data and other information to and from
the flow generators. To enhance patient comfort, convenience and compliance, we market a variety of other products and accessories. These products
include humidifiers, helping to prevent the drying of nasal passages that can cause discomfort, carry bags and breathing circuits. With the
introduction of our latest generation of flow generators, we are expanding our use of cloud-based patient management and engagement platforms
such as AirView and myAir enabling remote monitoring, over-the-air trouble shooting and changing of device settings.
D ATA / P ATIENT
M ANAGEMENT P RODUCTS
S9 Embletta Adapter
ResScan v3.14
ResTraxx v17.1
ResTraxx v 18.3
ResScan V3.16
D ESCRIPTION
D ATE OF
C OMMERCIAL
I NTRODUCTION
The S9 Embletta Adapter provides a connection between an S9 device and
an Embletta Portable Diagnostic System
November 2010
An easy and flexible patient monitoring system providing therapy
insights. This version included support for S9 bilevel and cross-patient
first 30 days compliance reporting.
ResMed’s web-based compliance monitoring system which introduced
several new features to ResTraxx Online reports and enhanced support for
S9 VPAP devices.
April 2011
April 2011
ResMed’s web-based compliance monitoring system introducing
EasyCare Card – online compliance reporting direct from device SD card
to ResTraxx Online
November 2011
ResMed’s easy and flexible patient monitoring system providing therapy
insights and supporting VS and Elise ventilation products (Europe)
November 2011
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D ATA / P ATIENT
M ANAGEMENT P RODUCTS
EasyCare
U-Sleep
AirView
myAir
S+
D ESCRIPTION
ResMed’s new compliance management solution offers both wireless and
card-to-cloud functionality, providing access to patient data anywhere
with an internet connection. Intuitive user interface, easy to understand
reports and automated compliance notification.
A flexible compliance solution that monitors CPAP device usage and
helps HMEs manage their patients during their initial acclimatization and
ongoing therapy.
AirView is a seamless, cloud-based system enabling remote monitoring
and changing of patients’ device settings. AirView also makes it easier to
simplify workflows and collaborate more efficiently across the patient’s
care network.
A personalized therapy management application for patients with sleep-
disordered breathing providing support, education and troubleshooting
tools for increased patient engagement and improved compliance.
A personalized sleep solution that uses patented bio-motion sensors,
designed to measure an individual’s sleep stages and environment, and
deliver personalized feedback that helps improve sleep.
D ATE OF
C OMMERCIAL
I NTRODUCTION
April 2012
August 2012
August 2014
October 2014
October 2014
Product Development and Clinical Trials
We have a strong track record in innovation in the sleep market. In 1989, we introduced our first CPAP device. Since then we have been committed
to an ongoing program of product advancement and development. Currently, our product development efforts are focused on not only improving our
current product offerings, but also expanding into new product applications.
We continually seek to identify new applications of our technology for significant unmet medical needs. SDB is associated with a number of
symptoms beyond excessive daytime sleepiness and irritability. Studies have established a clinical association between SDB and hypertension,
stroke, congestive heart failure and diabetes. We support clinical trials in many countries including the United States, Germany, France, the United
Kingdom, Italy, Switzerland, China and Australia to develop new clinical applications for our technology.
We consult with physicians at major sleep centers throughout the world to identify technological trends in the treatment of SDB. New product ideas
are also identified by our marketing staff, direct sales force, network of distributors, customers and patients.
In fiscal years 2015, 2014, and 2013 we invested $114.9 million, $118.2 million and $120.1 million, respectively, on research and development.
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Sales and Marketing
We currently market our products in more than 100 countries through a network of distributors and our direct sales force. We attempt to tailor our
marketing approach to each national market, based on regional awareness of SDB as a health problem, physician referral patterns, consumer
preferences and local reimbursement policies. See Note 15 – Segment Information of the Notes to Consolidated Financial Statements (Part II, Item 8)
for financial information about our geographic areas.
North America 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 his or her staff; the home healthcare dealer; the insurer and the patient. In North and Latin America, our
sales and marketing activities are conducted through a field sales organization made up of regional territory representatives, program development
specialists and regional sales directors. Our field sales organization markets and sells products to home healthcare dealer branch locations throughout
North and Latin America.
We also market our products directly to physicians and sleep clinics. Patients who are diagnosed with OSA or another respiratory condition and
prescribed our products are typically referred by the diagnosing physician or sleep clinic to a home healthcare dealer to fill the prescription. The
home healthcare dealer, in consultation with the referring physician, will assist the patient in selecting the equipment, fit the patient with the
appropriate mask and set the flow generator pressure to the prescribed level.
Sales in North and Latin America accounted for 57%, 54% and 56% of our net revenues for fiscal years 2015, 2014, and 2013, respectively.
Europe. We market our products in most major European countries. We have wholly-owned subsidiaries in Austria, Czech Republic, Finland,
France, Germany, Ireland, Netherlands, Norway, Poland, Sweden, Switzerland and the United Kingdom. We use independent distributors to sell our
products in other areas of Europe. Distributors are selected in each country based on their knowledge of respiratory medicine and a commitment to
SDB therapy. In each country in which we sell our products direct, a local senior manager is responsible for direct national sales. In many countries
in Europe, we sell our products to home healthcare dealers who then sell the products to the patients. In Germany, we also operate a home healthcare
company, in which we provide products and services directly to patients, and receive reimbursement directly from third-party payors.
Sales in Europe accounted for 32%, 36% and 33% of our total net revenues for fiscal years 2015, 2014, and 2013, respectively.
Asia Pacific. We have wholly-owned subsidiaries in Australia, China, Hong Kong, India, Japan, Korea, New Zealand, and Taiwan. We use a
combination of our direct sales force and independent distributors to sell our products in Asia Pacific. In Australia and New Zealand, we operate a
home healthcare business and sell our products and services directly to patients. Sales in Asia Pacific accounted for 11%, 10% and 11% of our total
net revenues for the fiscal years 2015, 2014, and 2013, respectively.
Market Growth Opportunities
We view the future as having three horizons of growth within the sleep and respiratory disorders sector of the medical device industry. The first
horizon includes our existing market in OSA treatment, where telemedicine is becoming an important factor. The use of technologies that allow
remote collection and transfer of information may change the current clinical pathways for following
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up patients on our devices and provides an opportunity to improve our services. We are investing in expanding our capabilities in this area.
The second horizon includes the use of our devices for the treatment of respiratory failure both in the hospital and the home. An area of growth is
expected to be in the treatment of chronic obstructive pulmonary disease, or COPD, which is an increasingly common chronic disease. Some patients
with advanced COPD may benefit from the use of ventilation at night, but until recently only a small number of COPD patients were treated using
ventilation on a long term basis. A study published in 2014 has demonstrated a reduction in mortality and an improvement in quality of life and
exercise capacity in COPD patients with stable but severe disease using non-invasive ventilation or NIV, nightly for 6 months. The findings from
this study and our associated marketing activities may result in an increase in the size of the homecare market for NIV. Additionally, the use of NIV
is becoming routine in most acute care hospitals, as guidelines stipulate its use in acute exacerbations and familiarity with the techniques involved
increases. The second horizon also includes several initiatives to expand our presence in high growth and emerging markets including China, India
and Brazil.
The focus of the third horizon is the cardiology market and respiratory monitoring solutions for heart failure and COPD. There is a growing body of
literature documenting the association and interactions between a number of cardiac diseases and SDB. OSA is the most common secondary cause of
hypertension and is prevalent in hypertensive populations, particularly those resistant to therapy. Treatment with CPAP tends to lower blood
pressure. OSA is prevalent in those with atrial fibrillation and may trigger episodes of fibrillation. Treatment with CPAP appears to improve
outcomes. OSA is also known to be a strong risk factor for the development of acute coronary disease and cardiovascular disease in general. Heart
failure is also commonly associated with both OSA and CSA, and both forms of SDB are risk factors for poor outcomes. We are undertaking several
clinical trials in cardiology to strengthen the knowledge base on the effects of SDB therapy on outcomes. In addition to clinical trials we pursue
suitable opportunities with professional and healthcare associations to raise awareness of the importance of SDB in cardiology patients.
We are also continuing our work to raise awareness of SDB in diabetes. OSA is common in diabetic patient populations and those with metabolic
syndrome. OSA has a number of deleterious effects in these diseases and importantly raises the risk of cardiovascular disease, if left untreated.
We are also working with occupational health professionals to raise awareness of the issues caused by untreated OSA in the workplace including
accidents, absenteeism and reduced productivity, plus increased costs for employers who provide healthcare coverage for employees.
We continue to provide research funding in these strategic areas while at the same time providing educational support to physicians working within
these various specialties. We believe that the increasing awareness among physicians supports the efforts and investment we are making in new
markets.
Manufacturing
Our manufacturing operations consist primarily of assembly and testing of our flow generators, masks and accessories. Of the numerous raw
materials, parts and components purchased for assembly of our therapeutic and diagnostic sleep disorder products, most are off-the-shelf items
available from multiple vendors. We also purchase uniquely configured components from various suppliers, including some who are single-source
suppliers for us. Any reduction or halt in supply from one of these single-source suppliers could limit our ability to manufacture our products or
devices until a replacement supplier is found and qualified. We generally manufacture to our internal sales forecasts
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and fill orders as received. Over the last few years, the manufacturing processes have been transformed along lean manufacturing guidelines to flow
lines staffed by dedicated teams. Each team is responsible for the manufacture and quality of their product group and decisions are based on
performance and quality measures, including customer feedback.
Our quality management system is based upon the requirements of ISO 9001, ISO 13485, FDA Quality System Regulations for Medical Devices, the
Medical Device Directive (93/42/EEC) and other applicable regulations for the markets in which we sell. All of our manufacturing sites are
accredited to ISO 13485. These sites are subject to third-party audits, conducted by the ISO notified bodies, at regular intervals.
Details of our main manufacturing facilities are:
Location
Norwest,
Sydney,
Australia
Singapore,
Singapore
Chatsworth,
California
Paris, France
Freudenstadt,
Germany
Johor Bahru,
Malaysia
Ownership Status
(Owned / Leased)
Owned
Square footage
155,000
Primary manufacturing site – full product range
Primary Usage
Leased
Leased
Leased
Owned
Leased
95,000
Primary manufacturing site – full product range
72,000
Manufacturing facility for motor manufacturing
43,000
43,000
Manufacturing facility for mechanical ventilators and accessories
Manufacturing facility for medical humidification products
46,000
Manufacturing facility for headgear and accessories.
Third-Party Coverage and Reimbursement
The cost of medical care in many of the countries in which we operate is funded in substantial part by government and private insurance programs.
In Germany, we receive payments directly from these payors. Outside Germany, although we do not generally receive payments for our products
directly from these payors, our success in major markets is dependent upon the ability of patients to obtain coverage and adequate reimbursement
from third-party payors for our products.
In the United States, our products are purchased primarily by home healthcare dealers, hospitals or sleep clinics, which then invoice third-party
payors directly for reimbursement. Domestic third-party payors include government payors such as Medicare and Medicaid and commercial health
insurance plans. These payors may deny coverage and reimbursement if they determine that a device is not used in accordance with certain covered
treatment methods, or is experimental, unnecessary or inappropriate. The long-term trend towards cost-containment, through managed healthcare, or
other legislative proposals to reform healthcare, could control or significantly influence the purchase of healthcare services and products and could
result in lower prices for our products. In some foreign markets, such as France, Germany and Japan, government reimbursement is currently
available for purchase or rental of our products, subject to constraints such as price controls or unit sales limitations. In Australia and in some other
foreign markets, there is currently limited or no reimbursement for devices that treat OSA.
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The past decade of legislative reform in the United States, including, by way of example, the 2010 Patient Protection and Affordable Care Act, as
amended by the Health Care and Education Reconciliation Act (collectively, the PPACA), Medicare Improvement for Patients and Providers Act of
2008 (MIPPA), Deficit Reduction Act of 2005 (DRA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA),
has significantly impacted reimbursement for products that we provide. The longer term impact, though not entirely predictable, continues to bring
significant changes to the third-party payor landscape.
Beginning in 2005, the MMA established a Medicare competitive acquisition program for HME and imposed quality standards and accreditation
requirements for HME suppliers. Effective 2011, the Centers for Medicare & Medicaid Services (CMS) implemented the first round of competitive
bidding in 9 competitive bidding areas, or CBAs, and included home medical equipment that we manufacture and develop, specifically, CPAP and
respiratory assist devices, and related supplies and accessories. The average reduction from current Medicare payment rates in the first round of
competitive bidding implemented was approximately 32% overall and 34% for CPAP and respiratory devices. In 2013, CMS announced the single
payment amounts for the second round, which covered a total of 91 CBAs. For CPAP and respiratory devices, the average reduction from current
Medicare payment rates in the second round was approximately 47% on a weighted average basis. CMS is required by law to recompete these
contracts at least once every three years. In addition, CMS has announced it will use single payment amounts established by competitive bidding to
set payment rates in areas not subject to competitive bidding. New rates will be phased in beginning January 1, 2016, and fully effective July 1,
2016.
The PPACA, which was passed both to expand the number of individuals with healthcare coverage and to develop additional revenue sources,
includes, among other things, a deductible excise tax equal to 2.3% of the price for which medical devices are sold in the United States on any entity
that manufactures or imports medical devices, with limited exceptions, beginning in 2013. This excise tax is applicable to our products that are
primarily used in hospitals and sleep labs, which includes the ApneaLink, VPAP Tx, certain Respiratory Care and dental sleep products. The PPACA
also provides for a number of Medicare regulatory requirements, including new face-to-face encounter requirements for durable medical equipment
and home health services; and a requirement that by 2016, the competitive bidding process must be rolled-out nationally or prices in non-competitive
bidding areas must be adjusted to match competitive bidding prices.
We cannot predict at this time the full impact of the PPACA, or any U.S. legislation enacted in the future will have on our revenues, profit margins,
profitability, operating cash flows and results of operations.
Service and Warranty
We generally offer either one-year or two-year limited warranties on our flow generator products. Warranties on mask systems are for 90 days. Our
distributors either repair our products with parts supplied by us or arrange shipment of products to our facilities for repair or replacement.
We receive returns of our products from the field for various reasons. We believe that the level of returns experienced to date is consistent with
levels typically experienced by manufacturers of similar devices. We provide for warranties and returns based on historical data.
Competition
The markets for our products are highly competitive. We believe that the principal competitive factors in all of our markets are product features,
reliability and price. Customer support, reputation and efficient distribution are also important factors.
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We compete on a market-by-market basis with various companies, some of which have greater financial, research, manufacturing and marketing
resources than us. Our primary competitors include Philips BV; DeVilbiss Healthcare; Fisher & Paykel Healthcare Corporation Limited; Apex
Medical Corporation; BMC Medical Co. Ltd.; and regional manufacturers. The disparity between our resources and those of our competitors may
increase as a result of the trend towards consolidation in the healthcare industry. In addition, some of our competitors, such as Weinmann Geräte für
Medizin GmbH + Co. KG, are affiliates of customers of ours, which may make it difficult to compete with them. Finally, our products compete with
surgical procedures and dental appliances designed to treat OSA and other SDB-related respiratory conditions. The development of new or
innovative procedures or devices by others could result in our products becoming obsolete or noncompetitive, which would harm our revenues and
financial condition.
Any product developed by us that gains regulatory clearance will have to compete for market acceptance and market share. An important factor in
such competition may be the timing of market introduction of competitive products. Accordingly, the speed with which we can develop products,
complete clinical testing and regulatory clearance processes and supply commercial quantities of the product to the market are important competitive
factors. In addition, our ability to compete will continue to be dependent on successfully protecting our patents and other intellectual property.
Patents and Proprietary Rights and Related Litigation
We rely on a combination of patents, trade secrets, copyrights, trademarks and non-disclosure agreements to protect our proprietary technology and
rights.
Through our various subsidiaries, as of the date of this annual report, we own or have licensed rights to approximately 958 issued United States
patents (including approximately 380 design patents) and approximately 1,737 issued foreign patents. In addition, there are approximately 458
pending United States patent applications (including approximately 54 design patent applications), approximately 1,003 pending foreign patent
applications, approximately 1,180 registered foreign designs and 146 pending foreign designs. Some of these patents, patent applications and designs
relate to significant aspects and features of our products.
Of our patents, 168 United States patents and 395 foreign patents are due to expire in the next five years. There are 15 foreign patents due to expire
in 2016, 28 in 2017, 109 in 2018, 61 in 2019, and 182 in 2020. There are 5 United States patents due to expire in 2016, 22 United States patents in
2017, 53 United States patents in 2018, 17 United States patents in 2019, and 71 United States patents in 2020. We believe that the expiration of
these patents will not have a material adverse impact on our competitive position.
Litigation may be necessary to enforce patents issued to us, to protect our rights, or to defend third-party claims of infringement by us of the
proprietary rights of others. The defense and prosecution of patent claims, including pending claims, as well as participation in other inter-party
proceedings, can be expensive and time-consuming, even in those instances in which the outcome is favorable to us. Patent laws regarding the
enforceability of patents vary from country to country. Therefore, there can be no assurance that patent issues will be uniformly resolved, or that
local laws will provide us with consistent rights and benefits.
Government Regulations
FDA
Our products are subject to extensive regulation particularly as to safety, efficacy and adherence to FDA Quality System Regulation, and related
manufacturing standards. Medical device products are subject to rigorous FDA and other governmental agency regulations in the United States and
similar
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regulations of foreign agencies abroad. The FDA regulates the design, development, research, preclinical and clinical testing, introduction,
manufacture, advertising, labeling, packaging, marketing, distribution, import and export, and record keeping for such products, in order to ensure
that medical products distributed in the United States are safe and effective for their intended use. In addition, the FDA is authorized to establish
special controls to provide reasonable assurance of the safety and effectiveness of most devices. Non-compliance with applicable requirements can
result in import detentions, fines, civil and administrative penalties, injunctions, suspensions or losses of regulatory approvals, recall or seizure of
products, operating restrictions, refusal of the government to approve product export applications or allow us to enter into supply contracts, and
criminal prosecution.
Unless an exemption applies, the FDA requires that a manufacturer introducing a new medical device or a new indication for use of an existing
medical device obtain either a Section 510(k) premarket notification clearance or a premarket approval, or PMA, before introducing it into the U.S.
market. The type of marketing authorization is generally linked to the classification of the device. The FDA classifies medical devices into one of
three classes (Class I, II or III) based on the degree of risk the FDA determines to be associated with a device and the level of regulatory control
deemed necessary to ensure the device’s safety and effectiveness.
Our products currently marketed in the United States are marketed in reliance on 510(k) pre-marketing clearances as either Class I or Class II
devices. The process of obtaining a Section 510(k) clearance generally requires the submission of performance data and often clinical data, which in
some cases can be extensive, to demonstrate that the device is “substantially equivalent” to a device that was on the market before 1976 or to a
device that has been found by the FDA to be “substantially equivalent” to such a pre-1976 device, a predecessor device is referred to as “predicate
device.” As a result, FDA clearance requirements may extend the development process for a considerable length of time. In addition, in some cases,
the FDA may require additional review by an advisory panel, which can further lengthen the process. The PMA process, which is reserved for new
devices that are not substantially equivalent to any predicate device and for high-risk devices or those that are used to support or sustain human life,
may take several years and requires the submission of extensive performance and clinical information.
Medical devices can be marketed only for the indications for which they are cleared or approved. After a device has received 510(k) clearance for a
specific intended use, any change or modification that significantly affects its safety or effectiveness, such as a significant change in the design,
materials, method of manufacture or intended use, may require a new 510(k) clearance or PMA approval and payment of an FDA user fee. The
determination as to whether or not a modification could significantly affect the device’s safety or effectiveness is initially left to the manufacturer
using available FDA guidance; however, the FDA may review this determination to evaluate the regulatory status of the modified product at any
time and may require the manufacturer to cease marketing and recall the modified device until 510(k) clearance or PMA approval is obtained. The
manufacturer may also be subject to significant regulatory fines or penalties. The FDA is currently reviewing its guidance describing when it
believes a manufacturer is obligated to submit a new 510(k) for modifications or changes to a previously cleared device. The FDA is expected to
issue revised guidance to assist device manufacturers in making this determination. It is unclear whether the FDA’s approach in this new guidance
will result in substantive changes to existing policy and practice regarding the assessment of whether a new 510(k) is required for changes or
modifications to existing devices.
Any devices we manufacture and distribute pursuant to clearance or approval by the FDA are subject to pervasive and continuing regulation by the
FDA and certain state agencies. These include product listing and establishment registration requirements, which help facilitate FDA inspections and
other regulatory actions. As a medical device manufacturer, all of our manufacturing facilities are subject to
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inspection on a routine basis by the FDA. We are required to adhere to applicable regulations setting forth detailed cGMP requirements, as set forth
in the QSR, which require, manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other
quality assurance procedures during all phases of the design and manufacturing process. Noncompliance with these standards can result in, among
other things, fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of production, refusal of the government to
grant 510(k) clearance or PMA approval of devices, withdrawal of marketing approvals and criminal prosecutions. We believe that our design,
manufacturing and quality control procedures are in compliance with the FDA’s regulatory requirements.
We must also comply with post-market surveillance regulations, including medical device reporting, or MDR, requirements which require that we
review and report to the FDA any incident in which our products may have caused or contributed to a death or serious injury. We must also report
any incident in which our product has malfunctioned if that malfunction would likely cause or contribute to a death or serious injury if it were to
recur.
Labeling and promotional activities are subject to scrutiny by the FDA and, in certain circumstances, by the Federal Trade Commission. Medical
devices approved or cleared by the FDA may not be promoted for unapproved or uncleared uses, otherwise known as “off-label” promotion. The
FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have
improperly promoted off-label uses may be subject to significant liability, including substantial monetary penalties and criminal prosecution.
Sales of medical devices outside the United States are subject to regulatory requirements that vary widely from country to country. Approval for sale
of our medical devices in Europe is through the CE mark process. Where appropriate, our products are CE marked to the European Union’s Medical
Device Directive. Under the CE marketing scheme, our products are classified as either Class I or Class II. Our devices are listed in Australia with
the Therapeutic Goods Administration, and in Canada with Health Canada.
Other
Healthcare
Laws
Even though we do not submit claims or bill governmental programs and other third-party payers directly for reimbursement for our products sold in
the United States, we are still subject to a number of laws and regulations that may restrict our business practices, including, without limitation, anti-
kickback, false claims, physician payment transparency and data privacy and security laws. The government has interpreted these laws broadly to
apply to the marketing and sales activities of manufacturers and distributors like us.
The federal Anti-Kickback Statute prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or
providing remuneration, directly or indirectly, in cash or in kind, in exchange for or to induce either the referral of an individual for, or the purchase,
lease, order or recommendation of, any good, facility, item or service for which payment may be made, in whole or in part, under federal healthcare
programs such as Medicare and Medicaid. In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback
Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
The federal civil False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false
or fraudulent claim for payment or approval to the federal government or knowingly making, using or causing to be made or used a false record or
statement material to a false or fraudulent claim to the federal government. A claim includes “any request or demand” for money or property
presented to the U.S. government. The civil False Claims
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Act also applies to false submissions that cause the government to be paid less than the amount to which it is entitled, such as a rebate. Intent to
deceive is not required to establish liability under the civil False Claims Act.
The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created federal criminal statutes that prohibit among other
actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-
party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a
healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or
fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Like the Anti-Kickback Statute, a
person or entity does not need to have actual knowledge of these statutes or specific intent to violate them in order to have committed a violation.
Also, many states and countries outside the U.S. have similar fraud and abuse statutes or regulations that may be broader in scope and may apply
regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs.
Under HIPAA, the Department of Health and Human Services, or HHS, has issued regulations to protect the privacy and security of protected health
information used or disclosed by covered entities including health care providers, such as us. HIPAA also regulates standardization of data content,
codes and formats used in health care transactions and standardization of identifiers for health plans and providers. Penalties for violations of HIPAA
regulations include civil and criminal penalties. In addition to federal privacy and security regulations, there are a number of state laws governing
confidentiality and security of health information that are applicable to our business. New laws governing privacy may be adopted in the future as
well. Failure to comply with privacy requirements could result in civil or criminal penalties, which could have a materially adverse effect on our
business.
Additionally, there has been a recent trend of increased federal and state regulation of payments and transfers of value provided to healthcare
professionals or entities. The Physician Payment Sunshine Act was enacted in law as part of PPACA, which imposed new annual reporting
requirements on device manufacturers for payments and other transfers of value provided by them, directly or indirectly, to physicians and teaching
hospitals, as well as ownership and investment interests held by physicians and their family members. A manufacturer’s failure to submit timely,
accurately and completely the required information for all payments, transfers of value or ownership or investment interests may result in civil
monetary penalties. Certain states also mandate implementation of commercial compliance programs, impose restrictions on device manufacturer
marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to healthcare professionals and entities.
The shifting commercial compliance environment and the need to build and maintain robust systems to comply with different compliance or
reporting requirements in multiple jurisdictions increase the possibility that a healthcare company may fail to comply fully with one or more of these
requirements. If our operations are found to be in violation of any of the health regulatory laws described above or any other laws that apply to us,
we may be subject to penalties, including potentially significant criminal and civil and administrative penalties, damages, fines, disgorgement,
imprisonment, exclusion from participation in government healthcare programs, contractual damages, reputational harm, administrative burdens,
diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to
operate our business and our results of operations.
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Employees
As of June 30, 2015, we had approximately 4,340 employees or full-time consultants, of which approximately 1,660 were employed in warehousing
and manufacturing, 570 in research and development and 2,110 in sales, marketing and administration. Of our employees and consultants,
approximately 1,360 were located in Australia, 890 in North and Latin America, 1,330 in Europe and 760 in Asia.
We believe that the success of our business will depend, in part, on our ability to attract and retain qualified personnel.
I TEM 1A
R ISK F ACTORS
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. The risks and uncertainties described below are not the only ones we face. Additional risks
and uncertainties not presently known to us or that we currently deem immaterial may also affect our business. If any of these known or unknown
risks or uncertainties actually occurs with material adverse effects on us, our business, financial condition and results of operations could be seriously
harmed. In that event, the market price for our common stock will likely decline, and you may lose all or part of your investment.
Our inability to compete successfully in our markets may harm our business. The markets for our SDB products are highly competitive and
are characterized by frequent product improvements and evolving technology. Our ability to compete successfully depends, in part, on our ability to
develop, manufacture and market innovative new products. The development of innovative new products by our competitors or the discovery of
alternative treatments or potential cures for the conditions that our products treat could make our products noncompetitive or obsolete. Current
competitors, new entrants, academics, and others are trying to develop new devices, alternative treatments or cures, and pharmaceutical solutions to
the conditions our products treat.
Additionally, some of our competitors have greater financial, research and development, manufacturing and marketing resources than we do. The
past several years have seen a trend towards consolidation in the healthcare industry and in the markets for our products. Industry consolidation
could result in greater competition if our competitors combine their resources, if our competitors are acquired by other companies with greater
resources than ours, or if our competitors become affiliated with customers of ours. This competition could increase pressure on us to reduce the
selling prices of our products or could cause us to increase our spending on research and development and sales and marketing. 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 or gross margins could decrease which would harm our business.
Our business depends on our ability to market effectively to dealers of home healthcare products and sleep clinics. We market our products
primarily to home healthcare dealers and to sleep clinics that diagnose OSA and other sleep disorders, as well as to non-sleep specialist physician
practices that diagnose and treat sleep disorders. We believe that these groups play a significant role in determining which brand of product a patient
will use. The success of our business depends on our ability to market effectively to these groups to ensure that our products are properly marketed
and sold by these third-parties.
We have limited resources to market to the sleep clinics, home healthcare dealer branch locations and to the non-sleep specialists, most of whom use,
sell or recommend several brands of products. In
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addition, home healthcare dealers have experienced price pressures as government and third-party reimbursement has declined for home healthcare
products, and home healthcare dealers are requiring price discounts and longer periods of time to pay for products purchased from us. We cannot
assure you that physicians will continue to prescribe our products, or that home healthcare dealers or patients will not substitute competing products
when a prescription specifying our products has been written.
We have expanded our marketing activities to target the population with a predisposition to sleep-disordered breathing as well as primary care
physicians and various medical specialists. We cannot assure you that these marketing efforts will be successful in increasing awareness or sales of
our products.
Consolidation in the health care industry could have an adverse effect on our revenues and results of operations. Many home health care
dealers are consolidating which may result in greater concentration of market power. As the health care industry consolidates, competition to provide
goods and services to industry participants may become more intense. These industry participants may try to use their market power to negotiate
price concessions or reductions for medical devices and components produced by us. If we are forced to reduce our prices because of consolidation
in the health care industry, our revenues may decrease and our consolidated earnings, financial condition, and/or cash flows may suffer.
If we are unable to support our continued growth, our business could suffer. We have experienced rapid and substantial growth. As we
continue to grow, the complexity of our operations increases, placing greater demands on our management. 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 including, the ability to monitor and improve manufacturing systems, information technology, and quality and regulatory
compliance systems, among others. Unexpected difficulties during expansion, the failure to attract and retain qualified employees, the failure to
successfully replace or upgrade our management information systems, the failure to manage costs or our inability to respond effectively to growth or
plan for future expansion could cause our growth to stop. If we fail to manage our growth effectively and efficiently, our costs could increase faster
than our revenues and our business results could suffer.
If we fail to integrate our recent acquisitions with our operations, our business could suffer. We continue to integrate our recent acquisitions
into our operations and we may find it difficult to integrate the operations as personnel may leave and licensees, distributors or suppliers may
terminate their arrangements or demand amended terms to these arrangements. Additionally, our management may have their attention diverted
while trying to integrate these businesses. If we are not able to successfully integrate the operations, we may not realize the anticipated benefits of
the acquisitions.
We are subject to various risks relating to international activities that could affect our overall profitability. We manufacture substantially
all of our products outside the United States and sell a significant portion of our products in non-U.S. markets. Sales outside North and Latin
America accounted for approximately 43% and 46% of our net revenues in the years ended June 30, 2015 and 2014, respectively. We expect that
sales within these areas will account for approximately 45% of our net revenues in the foreseeable future. Our sales and operations outside of the
U.S. are subject to several difficulties and risks that are separate and distinct from those we face in the U.S., including:
•
•
•
•
fluctuations in currency exchange rates;
tariffs and other trade barriers;
compliance with foreign medical device manufacturing regulations;
difficulty in enforcing agreements and collecting receivables through foreign legal systems;
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•
•
•
•
•
reduction in third-party payor reimbursement for our products;
inability to obtain import licenses;
changes in trade policies and in U.S. and foreign tax policies;
possible changes in export or import restrictions; and
the modification or introduction of other governmental policies with potentially adverse effects.
Any of the above factors may have a material adverse effect on our ability to increase or maintain our non-U.S sales.
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. Our ability to sell our products depends in large part on the extent to which coverage and reimbursement
for our products will be available from government health administration authorities, private health insurers and other organizations. These third-
party payers are increasingly challenging the prices charged for medical products and services and can, without notice, deny coverage for our
products or treatments that may include the use of our products. Therefore, even if a product is approved for marketing, we cannot make assurances
that coverage and reimbursement will be available for the product, that the reimbursement amount will be adequate or that the reimbursement
amount, even if initially adequate, will not be subsequently reduced. For example, in some markets, such as Spain, France and Germany, government
coverage and reimbursement are currently available for the purchase or rental of our products but are subject to constraints such as price controls or
unit sales limitations. In other markets, such as Australia, there is currently limited or no reimbursement for devices that treat SDB conditions. As we
continue to develop new products, those products will generally not qualify for coverage and reimbursement until they are approved for marketing, if
at all.
In the United States, we sell our products primarily to home healthcare dealers, hospitals and to sleep clinics. Reductions in reimbursement to our
customers by third-party payers, if they occur, may have a material impact on our customers and, therefore, may indirectly affect our sales to, or the
collectability of receivables we have from, those customers. A development affecting reimbursement negatively stems from the Medicare
competitive bidding program mandated by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or MMA. Under the
program, our customers who provide home healthcare services must compete to offer products in designated competitive bidding areas, or CBAs.
Under PPACA, by 2016, the competitive bidding process must either be rolled-out nationally or Medicare prices in non-competitive bidding areas
must be reduced to match competitive bidding prices.
We cannot predict 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.
Healthcare reform, including recently enacted legislation, may have a material adverse effect on our industry and our results of operations.
In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively,
the “PPACA”) was signed into law in the United States. The PPACA makes changes that are expected to impact the medical device industry. One of
the principal purposes of the PPACA was to expand health insurance coverage to approximately 32 million Americans who were uninsured. The
PPACA requires adults not covered by an employer- or government-sponsored insurance plan to maintain health insurance coverage or pay a
penalty, a provision commonly referred to as the individual mandate. We cannot predict the impact of these coverage expansions, if any, on the sales
of our products.
The PPACA also contains a number of provisions designed to generate the revenues necessary to fund the coverage expansions. This includes new
fees or taxes on certain health-related industries,
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including medical device manufacturers. Beginning in 2013, entities that manufacture, produce or import medical devices were required to pay an
excise tax in an amount equal to 2.3% of the price for which such devices are sold in the United States. This excise tax is applicable to our products
that are primarily used in hospitals and sleep labs, which includes the ApneaLink, VPAP Tx, certain Respiratory Care and dental sleep products. In
addition to the competitive bidding changes discussed above, the PPACA also includes, among other things, demonstrations 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 increased funding and focus on comparative clinical effectiveness research, which compares and evaluates the risks and benefits,
clinical outcomes, effectiveness and appropriateness of products, may result in lower reimbursements by payers for our products and decreased
profits to us.
Other federal legislative changes have been proposed and adopted since the PPACA was enacted. On August 2, 2011, the President signed into law
the Budget Control Act of 2011, which, among other things, creates the Joint Select Committee on Deficit Reduction to recommend proposals in
spending reductions to Congress. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013
through 2021, triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare
payments to providers, including home healthcare companies, of up to 2% per fiscal year, which went into effect on April 1, 2013 and will remain in
effect through 2024 unless additional Congressional action is taken. On January 2, 2013, the American Taxpayer Relief Act of 2012, or the ATRA,
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.
Various healthcare reform proposals have also emerged at the state level within the United States.
The PPACA as well as other federal and/or state healthcare reform measures that may be adopted in the future, singularly or in the aggregate, could
have a material adverse effect on our business, financial condition and results of operations.
Failure to comply with anti-kickback and fraud regulations could result in substantial penalties and changes in our business operations.
Although we do not provide healthcare services, submit claims for third-party reimbursement, or receive payments directly from Medicare, Medicaid
or other third-party payors for our products, we are subject to healthcare fraud and abuse regulation and enforcement by federal, state and foreign
governments, which could significantly impact our business. In the United States, the laws that may affect our ability to operate include, but are not
limited to:
•
•
the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting,
receiving, offering, or paying remuneration, directly or indirectly, in cash or in kind, in exchange for or to induce either the referral of an
individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service for which payment may be made, in
whole or in part, under federal healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual
knowledge of this statute or specific intent to violate it to have committed a violation. The U.S. government has interpreted this law broadly to
apply to the marketing and sales activities of manufacturers and distributors like us;
federal civil and criminal false claims laws and civil monetary penalty laws, including civil whistleblower or qui tam actions, 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
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•
•
•
•
avoiding or decreasing an obligation to pay or transmit money or property to the federal government. These laws may apply to manufacturers
and distributors who provide information on coverage, coding, and reimbursement of their products to persons who do bill third-party payers;
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created federal criminal laws that prohibit
executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. A person or entity
does not need to have actual knowledge of these statutes or specific intent to violate them to have committed a violation;
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective
implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as
well as their business associates that perform services for them that involve individually identifiable health information, relating to the privacy,
security and transmission of individually identifiable health information without appropriate authorization, including mandatory contractual
terms as well as directly applicable privacy and security standards and requirements;
the federal Physician Sunshine Act requirements under the PPACA, which impose new reporting and disclosure requirements on device and
drug manufacturers for any “transfer of value” made or distributed by certain manufacturers of drugs, devices, biologics, and medical supplies
to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and ownership and
investment interests held by physicians and their immediate family members.
state and foreign law equivalents of each of the above federal laws, such as state anti-kickback and false claims laws that may apply to items or
services reimbursed by any third-party payor, including commercial insurers; state laws that require device companies to comply with the
industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict
payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report
information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state
and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in
significant ways and often are not preempted by HIPAA.
The scope and enforcement of these laws are uncertain and subject to rapid change in the current environment of healthcare reform, especially in
light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased their scrutiny of interactions
between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the
healthcare industry. Responding to investigations can be time-and resource-consuming and can divert management’s attention from the business.
Additionally, as a result of these investigations, healthcare providers and entities may have to agree to additional onerous compliance and reporting
requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise
have an adverse effect on our business. We also are subject to foreign fraud and abuse laws, which vary by country.
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the
future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement, exclusion from governmental health care
programs, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our
financial results.
Complying with Food and Drug Administration, or FDA, and other regulations is an expensive and time-consuming process, and any failure
to comply could have a materially adverse effect
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on our business, financial condition, or results of operations. We are subject to extensive U.S. federal, state, local and international regulations
regarding our business activities. Failure to comply with these regulations could result in, among other things, recalls of our products, substantial
fines and criminal charges against us or against our employees. Furthermore, our products could be subject to recall if the FDA, other regulators or
we determine, for any reason, that our products are not safe or effective. Any recall or other regulatory action could increase our costs, damage our
reputation, affect our ability to supply customers with the quantity of products they require and materially affect our operating results.
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. Unless a product is exempt, before we can market or sell a new medical device in the United
States, we must obtain FDA clearance or approval, which can be a lengthy and time-consuming process. We generally receive clearance from the
FDA to market our products in the United States under Section 510(k) of the Federal Food, Drug, and Cosmetic Act or our products are exempt from
the Section 510(k) clearance process. The 510(k) clearance process can be expensive, time-consuming and uncertain. In the 510(k) clearance
process, the FDA must determine that a proposed device is “substantially equivalent” to a device legally on the market, known as a “predicate”
device, with respect to intended use, technology and safety and effectiveness, in order to clear the proposed device for marketing. The FDA has a
high degree of latitude when evaluating submissions and may determine that a proposed device submitted for 510(k) clearance is not substantially
equivalent to a predicate device. After a device receives 510(k) premarket notification clearance from the FDA, any modification that could
significantly affect its safety or effectiveness, or that would constitute a major change in the intended use of the device, technology, materials,
packaging, and certain manufacturing processes may require a new 510(k) clearance or premarket approval. We have modified some of our
Section 510(k) approved products without submitting new Section 510(k) notices, which we do not believe were required. However, if the FDA
disagrees with us and requires us to submit new Section 510(k) notifications for modifications to our existing products, we may be required to stop
marketing the products while the FDA reviews the Section 510(k) notification.
Any new product introduction or existing product modification could be subjected to a lengthier, more rigorous FDA examination process. For
example, in certain cases we may need to conduct clinical trials of a new product before submitting a 510(k) notice. We may also be required to
obtain premarket approvals for certain of our products. Indeed, recent trends in the FDA’s review of premarket notification submissions suggest that
the FDA is often requiring manufacturers to provide new, more expansive, or different information regarding a particular device than what the
manufacturer anticipated upon 510(k) submission. This has resulted in increasing uncertainty and delay in the premarket notification review process.
For example, the FDA is currently reviewing its guidance describing when it believes a manufacturer is obligated to submit a new 510(k) for
modifications or changes to a previously cleared device. The FDA is expected to issue revised guidance to assist device manufacturers in making this
determination. It is unclear whether the FDA’s approach in this new guidance will result in substantive changes to existing policy and practice
regarding the assessment of whether a new 510(k) is required for changes or modifications to existing devices. The FDA’s ongoing review of the
510(k) program may make it more difficult for us to make modifications to our previously cleared products, either by imposing more strict
requirements on when a manufacturer must submit a new 510(k) for a modification to a previously cleared product, or by applying more onerous
review criteria to such submissions. FDA continues to review its 510(k) clearance process which could result in additional changes to regulatory
requirements or guidance documents which could increase the costs of compliance, or restrict our ability to maintain current clearances. The
requirements of the more
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rigorous premarket approval process and/or significant changes to the Section 510(k) clearance process could delay product introductions and
increase the costs associated with FDA compliance. Marketing and sale of our products outside the United States are also subject to regulatory
clearances and approvals, and if we fail to obtain these regulatory approvals, our sales could suffer. We cannot assure you that any new products we
develop will receive required regulatory approvals from U.S. or foreign regulatory agencies.
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. The FDA regulates
the approval, manufacturing, and sales and marketing of many of our products in the U.S. Significant government regulation also exists in Canada,
Japan, Europe, and other countries in which we conduct business. As a device manufacturer, we are required to register with the FDA and are subject
to periodic inspection by the FDA for compliance with the FDA’s Quality System Regulation requirements, which require manufacturers of medical
devices to adhere to certain regulations, including testing, quality control and documentation procedures. In addition, the federal Medical Device
Reporting regulations require us to provide information to the FDA whenever there is evidence that reasonably suggests that a device may have
caused or contributed to a death or serious injury or, if a malfunction were to occur, could cause or contribute to a death or serious injury.
Compliance with applicable regulatory requirements is subject to continual review and is rigorously monitored through periodic inspections by the
FDA. In the European Community, we are required to maintain certain ISO certifications in order to sell our products and must undergo periodic
inspections by notified bodies to obtain and maintain these certifications. Failure to comply with current governmental regulations and quality
assurance guidelines could lead to temporary manufacturing shutdowns, product recalls or related field actions, product shortages or delays in
product manufacturing. Efficacy or safety concerns, an increase in trends of adverse events in the marketplace, and/or manufacturing quality issues
with respect to our products could lead to product recalls or related field actions, withdrawals, and/or declining sales.
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. As a part of the regulatory process of obtaining marketing clearance for new products and new indications for existing products, we
conduct and participate in numerous clinical trials with a variety of study designs, patient populations, and trial endpoints. Unfavorable or
inconsistent clinical data from existing or future clinical trials conducted by us, by our competitors, or by third parties, or the market’s or regulatory
bodies’ perception of this clinical data, may adversely impact our ability to obtain product approvals, our position in, and share of, the markets in
which we participate, and our business, financial condition, and results of operations.
Off-label marketing of our products could result in substantial penalties. The FDA strictly regulates the promotional claims that may be made
about FDA-cleared products. In particular, clearance under Section 510(k) only permits us to market our products for the uses indicated on the
labeling cleared by the FDA. We may request additional label indications for our current products, and the FDA may deny those requests outright,
require additional expensive clinical data to support any additional indications or impose limitations on the intended use of any cleared products as a
condition of clearance. If the FDA determines that we have marketed our products for off-label use, we could be subject to fines, injunctions or other
penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our business activities to
constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil and administrative
penalties, damages, fines, disgorgement, exclusion from participation in government
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healthcare programs, and the curtailment of our operations. Any of these events could significantly harm our business and results of operations and
cause our stock price to decline.
Disruptions in the supply of components from our single source suppliers could result in a significant reduction in sales and profitability.
We purchase uniquely configured components for our devices from various suppliers, including some who are single-source suppliers for us. We
cannot assure you that a replacement supplier would be able to configure its components for our devices on a timely basis or, in the alternative, that
we would be able to reconfigure our devices to integrate the replacement part. A reduction or halt in supply while a replacement supplier
reconfigures its components, or while we reconfigure our devices for the replacement part, would limit our ability to manufacture our devices, which
could result in a significant reduction in sales and profitability. We cannot assure you that our inventories would be adequate to meet our production
needs during any prolonged interruption of supply.
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. We are subject to potential product liability claims as a result of the design, manufacture and marketing of
medical devices. Any product liability claim brought against us, with or without merit, could result in the increase of our product liability insurance
rates. In addition, we would have to pay any amount awarded by a court in excess of our policy limits. Our insurance policies have various
exclusions, and thus we may be subject to a product liability claim for which we have no insurance coverage, in which case, we may have to pay the
entire amount of any award. We cannot assure you that our insurance coverage will be adequate or that all claims brought against us will be covered
by our insurance and we cannot assure you that we will be able to obtain insurance in the future on terms acceptable to us or at all. A successful
product liability claim brought against us in excess of our insurance coverage, if any, may require us to pay substantial amounts, which could harm
our business.
Our intellectual property may not protect our products, and/or our products may infringe on the intellectual property rights of third-
parties. We rely on a combination of patents, trade secrets and non-disclosure agreements to protect our intellectual property. Our success
depends, in part, on our ability to obtain and maintain United States and foreign patent protection for our products, their uses and our processes to
preserve our trade secrets and to operate without infringing on the proprietary rights of third-parties. We have a number of pending patent
applications, and we do not know whether any patents will issue from any of these applications. We do not know whether any of the claims in our
issued patents or pending applications will provide us with any significant protection against competitive products or otherwise be commercially
valuable. Legal standards regarding the validity of patents and the proper scope of their claims are still evolving, and there is no consistent law or
policy regarding the valid breadth of claims. Additionally, there may be third-party patents, patent applications and other intellectual property
relevant to our products and technology which are not known to us and that block or compete with our products.
We face the risks that:
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third-parties will infringe our intellectual property rights;
our non-disclosure agreements will be breached;
we will not have adequate remedies for infringement;
our trade secrets will become known to or independently developed by our competitors; or
third-parties will be issued patents that may prevent the sale of our products or require us to license and pay fees or royalties in order for us to
be able to market some of our products.
Litigation may be necessary to enforce patents issued to us, to protect our proprietary rights, or to defend third-party claims that we have infringed
upon proprietary rights of others. The defense and
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prosecution of patent claims, including these pending claims, as well as participation in other inter-party proceedings, can be expensive and time-
consuming, even in those instances in which the outcome is favorable to us. If the outcome of any litigation or proceeding brought against us were
adverse, we could be subject to significant liabilities to third-parties, could be required to obtain licenses from third-parties, could be forced to design
around the patents at issue or could be required to cease sales of the affected products. A license may not be available at all or on commercially
viable terms, and we may not be able to redesign our products to avoid infringement. Additionally, the laws regarding the enforceability of patents
vary from country to country, and we cannot assure you that any patent issues we face will be uniformly resolved, or that local laws will provide us
with consistent rights and benefits.
We are subject to tax audits by various tax authorities in many jurisdictions. From time to time we may be audited by tax authorities in
various jurisdictions. Any final assessment resulting from such audits could result in material changes to our past or future taxable income, tax
payable or deferred tax assets, and could require us to pay penalties and interest that could materially adversely affect our financial results.
Our quarterly operating results are subject to fluctuation for a variety of reasons. Our operating results have, from time to time, fluctuated
on a quarterly basis and may be subject to similar fluctuations in the future. These fluctuations may result from a number of factors, including:
•
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the introduction of new products by us or our competitors;
the geographic mix of product sales;
the success and costs of our marketing efforts in new regions;
changes in third-party payor reimbursement;
timing of regulatory clearances and approvals;
timing of orders by distributors;
expenditures incurred for research and development;
competitive pricing in different regions;
the effect of foreign currency transaction gains or losses; and
other activities of our competitors.
Fluctuations in our quarterly operating results may cause the market price of our common stock to fluctuate.
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. Our facilities and the manufacturing equipment we use to produce our products
would be costly to replace and could require substantial lead-time to repair or replace. The facilities may be affected by natural or man-made
disasters and in the event they were affected by a disaster, we would be forced to rely on third-party manufacturers. Although we believe we possess
adequate insurance for the disruption of our business from causalities, such insurance may not be sufficient to cover all of our potential losses and
may not continue to be available to us on acceptable terms, or at all.
Delaware law and provisions in our charter and could make it difficult for another company to acquire us. Provisions of our certificate of
incorporation may have the effect of delaying or preventing changes in control or management which might be beneficial to us or our security
holders. In particular, our board of directors is divided into three classes, serving for staggered three-year terms. Because of this classification, it will
require at least two annual meetings to elect directors
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constituting a majority of our board of directors. Additionally, our board of directors has the authority to issue up to 2,000,000 shares of preferred
stock and to determine the price, rights, preferences, privileges and restrictions, including voting rights, of those shares without further vote or action
by the stockholders. The rights of the holders of our common stock will be subject to, and may be adversely affected by, the rights of the holders of
any preferred stock that may be issued in the future. The issuance of preferred stock may have the effect of delaying, deferring or preventing a
change in control, may discourage bids for our common stock at a premium over the market price of our common stock and may adversely affect the
market price of our common stock and the voting and other rights of the holders of our common stock.
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 Australian courts, where most of these assets and persons reside.
We are increasingly dependent on information technology systems and infrastructure. Our technology systems are potentially vulnerable to
breakdown or other interruption by fire, power loss, system malfunction, unauthorized access and other events. Likewise, data privacy breaches by
employees and others with both permitted and unauthorized access to our systems may pose a risk that sensitive data may be exposed to
unauthorized persons or to the public, or may be permanently lost. While we have invested heavily in the protection of data and information
technology and in related training, there can be no assurance that our efforts will prevent significant breakdowns, breaches in our systems or other
cyber incidents that could have a material adverse effect upon the reputation, business, operations or financial condition of the company. In addition,
significant implementation issues may arise as we continue to consolidate and outsource certain computer operations and application support
activities.
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, 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. If the economic climate in the United States or outside the United States continues to deteriorate or there is a
shift in government spending priorities, customers or potential customers could reduce or delay their purchases, which could impact our revenue, our
ability to manage inventory levels, collect customer receivables, and ultimately decrease our profitability.
I TEM 1B
U NRESOLVED S TAFF C OMMENTS
We have received no written comments regarding our periodic or current reports from the staff of the Securities and Exchange Commission that were
issued 180 days or more preceding the end of our fiscal year 2015 that remain unresolved.
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I TEM 2
P ROPERTIES
We conduct our operations in both owned and leased properties. Our principal executive offices and U.S. sales facilities, consisting of approximately
230,000 square feet, are located on Spectrum Center Boulevard in San Diego, California, in a building we own. We have our research and
development and office facilities and manufacturing facilities at our owned site in Norwest, Sydney, Australia. Warehousing and distribution
facilities are leased in Atlanta, Georgia, and Moreno Valley, California, U.S.A.; Abingdon, England; Munich, Bremen, Hochstadt, Germany; Lyon,
Paris, France; Basel, Switzerland; Stockholm, Sweden; Helsinki, Finland; Oslo, Norway; New Delhi, India; Tokyo, Japan and Dublin, Ireland,
Beijing, China; the Czech Republic and Poland.
We believe that our facilities are adequate to meet the needs of our current business operations. At June 30, 2015, our principal owned and leased
properties were as follows:
Location
San Diego,
California
Norwest,
Sydney,
Australia
Chatsworth,
California
Atlanta,
Georgia
Moreno
Valley,
California
Singapore,
Singapore
Munich,
Germany
Lyon, France
Paris, France
Freudenstadt,
Germany
Johor Bahru,
Malaysia
Ownership Status
(Owned / Leased)
Owned
Square footage
230,000
Corporate headquarters, sales and administration
Primary Usage
Owned
224,000
Manufacturing, engineering, research and development
Leased
Leased
Leased
Leased
Leased
Leased
Leased
Owned
Leased
72,000
Motor manufacturing, engineering, research and development
470,000
Warehouse and distribution
130,000
Warehouse and distribution
95,000
Manufacturing facility
119,000
Sales and distribution, research and development
52,000
43,000
43,000
Sales and distribution
Manufacturing facility, field service
Manufacturing facility
46,000
Manufacturing facility
I TEM 3
L EGAL P ROCEEDINGS
We are involved in various legal proceedings and claims. Litigation is inherently uncertain. Accordingly, we cannot predict the outcome of these
matters. But we do not expect the outcome of these matters to have a material adverse effect on our consolidated financial statements when taken as
a whole.
In 2013, we filed actions in the U.S. and Germany against Chinese manufacturer BMC Medical Co., Ltd and its U.S. distributor, 3B Medical, Inc. to
stop the infringement of several ResMed patents. The
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U.S. International Trade Commission initiated an investigation, and in December 2014, ruled that certain of BMC’s masks infringed ResMed’s
patents and should be excluded from importation or sale in the US. BMC subsequently notified the Commission that it discontinued US sales of the
mask products affected by the Commission’s order. The International Trade Commission also ruled that the claims of the patent against BMC’s
humidifier patent were anticipated by prior art, invalidated those claims, and declined to exclude BMC’s humidifier products from importation or
sale. Each party has appealed the International Trade Commission’s ruling. A companion case in the United States District Court for the Southern
District of California remains stayed pending those appeals. In 2013, we obtained preliminary injunctions prohibiting BMC from marketing and
selling certain flow generators and mask assemblies accused of patent infringement in Germany. The preliminary injunction against BMC’s mask
assemblies remains in effect, but in November 2014 the court dissolved the preliminary injunction against the sale of BMC’s flow generators, and
the court’s action dissolving that preliminary injunction was affirmed on appeal. ResMed continues to pursue the underlying German patent
infringement action against BMCs flow generators and mask assemblies.
In 2015, BMC’s U.S. distributor, 3B Medical, Inc., filed suit in the United States District Court for the Middle District of Florida against ResMed
Inc. and ResMed Corp. for alleged federal and state antitrust violations. Specifically, 3B Medical alleges that in addition to enforcing its patents,
ResMed has entered into exclusive dealing arrangements with customers, tied sales of masks to sales of flow generators, and spread false information
that 3B would go out of business due to ResMed’s patent infringement action. 3B Medical seeks damages and an injunction. ResMed Inc. has been
dismissed from the case, and ResMed Corp. has denied the allegations.
I TEM 4
M INE S AFETY D ISCLOSURES
Not Applicable.
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PART II
I TEM 5
M ARKET FOR R EGISTRANT ’ S C OMMON E QUITY , R ELATED S TOCKHOLDER M ATTERS AND I SSUER P URCHASES OF E QUITY S
ECURITIES
Our common stock is traded on the NYSE under the symbol “RMD”. The following table sets forth for the fiscal periods indicated the high and low
closing prices for the common stock as reported by the NYSE.
Quarter One, Ended September 30
Quarter Two, Ended December 31
Quarter Three, Ended March 31
Quarter Four, Ended June 30
2015
2014
High
Low
High
Low
$53.35
57.39
72.44
74.82
$48.65
46.25
56.65
55.44
$54.36 $43.26
45.36
57.11
47.82
42.03
44.43
53.76
At July 28, 2015, there were 26 holders of record of our common stock, although many of these holders of record own shares as nominees on behalf
of other beneficial owners. During fiscal years 2015 and 2014, we paid dividends totaling $157.3 million and $141.5 million, respectively. On
July 30, 2015, we announced an increase in the quarterly dividend from $0.28 per share to $0.30 per share. We pay the dividend in U.S. currency to
holders of our common stock trading on the NYSE. Holders of CDIs trading on the ASX will receive an equivalent amount in Australian currency
based on the exchange rate on the record date and reflecting the 10:1 ratio between CDIs and NYSE shares. We expect the dividend will continue to
be unfranked for Australian tax purposes. We expect to fund our dividend commitments with our operating cash flows and existing loan facilities.
Securities Authorized for Issuance Under Equity Compensation Plans
The information included under Item 12 of Part III of this Report, “Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters,” is hereby incorporated by reference into this Item 5 of Part II of this Report.
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Table of Contents
Purchases of Equity Securities
The following table summarizes purchases by us of our common stock during the fiscal year ending June 30, 2015:
Period
July 1 - 31, 2014
August 1 - 31, 2014
September 1 - 30, 2014
October 1 - 31, 2014
November 1 - 30, 2014
December 1 - 31, 2014
January 1 - 31, 2015
February 1 - 28, 2015
March 1 - 31, 2015
April 1 - 30, 2015
May 1 - 31, 2015
June 1 - 30, 2015
Total
Total
Number
of Shares
Purchased
182,579
257,986
394,922
416,982
75,000
175,000
0
92,500
207,500
165,000
438,571
337,699
2,743,739
Average
Price Paid
per Share
$ 49.50
51.65
51.93
48.16
53.40
53.93
-
65.03
68.91
64.45
58.15
58.62
$ 55.63
(1)
Total Number
of Shares
Purchased
36,625,074
36,883,060
37,277,982
37,694,964
37,769,964
37,944,964
37,944,964
38,037,464
38,244,964
38,409,964
38,848,535
39,186,234
39,186,234
Maximum Number of
Shares that May Yet Be
Purchased Under the
Programs
(1)
18,090,939
17,832,953
17,438,031
17,021,049
16,946,049
16,771,049
16,771,049
16,678,549
16,471,049
16,306,049
15,867,478
15,529,779
15,529,779
1
. On February 21, 2014, our board of directors approved a new share repurchase program, authorizing us to acquire up to an aggregate of 20 million shares of our common stock. The program
allows us to repurchase shares of our common stock from time to time for cash in the open market, or in negotiated or block transactions, as market and business conditions warrant and subject
to applicable legal requirements. There is no expiration date for this program, and the program may be accelerated, suspended, delayed or discontinued at any time at the discretion of our board
of directors. All share repurchases after February 21, 2014 have been executed under this program. Since the inception of the share buyback programs, we have repurchased 39.2 million shares at
a total cost of $1.4 billion.
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Table of Contents
PERFORMANCE GRAPH
This performance graph is furnished and shall not be deemed “filed” with the SEC or subject to Section 18 of the Exchange Act, nor shall it be
deemed incorporated by reference in any of our filings under the Securities Act of 1933, as amended.
The following graph compares the cumulative total stockholders return on our common stock from June 30, 2010 through June 30, 2015, with the
comparable cumulative return of the S&P 500 index, the S&P 500 Health Care index, and the Dow Jones US Medical Devices index. The graph
assumes that $100 was invested in our common stock and each index on June 30, 2010. In addition, the graph assumes the reinvestment of all
dividends paid. The stock price performance on the following graph is not necessarily indicative of future stock price performance.
The following table shows total indexed return of stock price plus reinvestments of dividends, assuming an initial investment of $100 at June 30,
2010, for the indicated periods.
Index
ResMed Inc
S&P 500
S&P 500 Health Care
Dow Jones US Medical Devices
June 2010
100
100
100
100
June 2011
102
128
126
126
- 35 -
June 2012
103
132
135
124
June 2013
150
156
169
149
June 2014
170
190
216
194
June 2015
191
200
263
229
Table of Contents
I TEM 6
S ELECTED F INANCIAL D ATA
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, 2015. The data set forth below should be read in conjunction with Item 7 of Part II of this annual report, “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” and Item 8 of Part II of this annual report, “Consolidated Financial Statements and
Supplementary Data”, and related Notes included elsewhere in this annual report. The consolidated statement of income data for the years ended
June 30, 2015, 2014 and 2013 and the consolidated balance sheet data as of June 30, 2015 and 2014 are derived from our audited consolidated
financial statements included elsewhere in this annual report. The consolidated statement of income data for the years ended June 30, 2012 and 2011
and the consolidated balance sheet data as of June 30, 2013, 2012 and 2011 are derived from our audited consolidated financial statements not
included herein. Historical results are not necessarily indicative of the results to be expected in the future, and the results for the years presented
should not be considered indicative of our future results of operations.
Consolidated Statement of Income Data
(In thousands, except per share data):
Net revenues
Cost of sales (excluding amortization of acquired
intangible assets)
Gross profit
Selling, general and administrative expenses
Research and development expenses
Restructuring expenses
Education, research and settlement charge
Amortization of acquired intangible assets
Total operating expenses
Income from operations
Other income:
Interest income, net
Other, net
Total other income, net
Income before income taxes
Income taxes
Net income
Basic earnings per share
Diluted earnings per share
Dividends per share
Weighted average:
Basic shares outstanding
Diluted shares outstanding
2015
$ 1,678,912
2014
$ 1,554,973
2013
2012
$ 1,514,457 $ 1,368,515
2011
$ 1,243,148
Years Ended June 30,
667,516
1,011,396
478,627
114,865
-
-
8,668
602,160
409,236
20,430
6,250
26,680
435,916
83,030
352,886
2.51
2.47
1.12
140,468
142,687
$
$
$
$
- 36 -
565,187
989,786
450,414
118,226
6,326
-
9,733
584,699
405,087
25,107
884
25,991
431,078
85,805
345,273
2.44
2.39
1.00
141,474
144,359
$
$
$
$
573,800
940,657
430,802
120,124
-
24,765
10,142
585,833
354,824
32,486
(2,191)
30,295
385,119
77,986
307,133 $
2.15 $
2.10 $
0.68 $
547,780
820,735
402,621
109,733
-
-
13,974
526,328
294,407
29,080
8,458
37,538
331,945
77,095
254,850
1.75
1.71
-
142,954
146,410
145,901
149,316
$
$
$
$
501,822
741,326
372,249
92,007
-
-
10,146
474,402
266,924
26,043
10,740
36,783
303,707
76,721
226,986
1.49
1.44
-
152,471
157,195
$
$
$
$
Table of Contents
Consolidated Balance Sheet Data
(In thousands):
Working capital
Total assets
Long-term debt, less current maturities
Total stockholders’ equity
2015
$ 1,176,923
2,184,260
300,594
$ 1,587,307
2014
$ 1,286,651
2,360,962
300,770
$ 1,758,248
- 37 -
As of June 30,
2012
$
2,210,721
769
2013
874,800 $ 1,108,299
2,137,869
250,783
$ 1,610,516 $ 1,607,627
2011
$ 1,083,612
2,068,922
100,000
$ 1,730,737
Table of Contents
I TEM 7
M ANAGEMENT ’ S D ISCUSSION AND A NALYSIS OF F INANCIAL C ONDITION AND R ESULTS OF O PERATIONS
Overview
Management’s discussion and analysis of financial condition and results of operations is intended to help the reader understand the results of
operations and financial condition of ResMed Inc and subsidiaries. It is provided as a supplement to, and should be read in conjunction with the
selected financial data and consolidated financial statements and notes included elsewhere in this Report.
We are a leading developer, manufacturer and distributor of medical equipment for treating, diagnosing, and managing sleep-disordered breathing
(“SDB”) and other respiratory disorders. During the fiscal year, we continued our efforts to build awareness of the consequences of untreated SDB
and to grow our business in this market. In our efforts, we have attempted to raise awareness through market and clinical initiatives and by
highlighting the increasing link between the potential effects SDB can have on co-morbidities such as cardiac disease, diabetes, hypertension and
obesity.
There are many studies being conducted that provide new evidence that treating SDB and OSA can improve health, quality of life and also mitigate
the dangers of sleep apnea in occupational health and safety, especially in the transport industry. Evidence continues to mount supporting the role of
SDB therapy for disease prevention, improvement of quality of life and healthcare cost reduction.
We are committed to ongoing investment in research and development and product enhancements. During fiscal year 2015, we invested
approximately $114.9 million on research and development activities, which represents approximately 7% of net revenues. Since the development of
CPAP, we have developed a number of innovative products for the treatment of SDB and other respiratory disorders including airflow generators,
diagnostic products, mask systems, headgear and other accessories. During fiscal year 2015, we released significant new products across our flow
generator categories, including the AirSense
10, AirView
monitoring and therapy management system. The release of these products as well as the release of AirFit™ P10, AirFit™ N10 and AirFit™F10
masks and the Astral™, in fiscal 2014, and a robust product pipeline, will continue to provide us with a strong platform for future growth.
and Lumis as well as the AirView
, our cloud-based remote
10, AirCurve
TM
TM
TM
TM
Net revenue in fiscal year 2015 increased to $1,678.9 million, an increase of 8% compared to fiscal year 2014. Gross profit increased for the year
ended June 30, 2015 to $1,011.4 million, from $989.8 million for the year ended June 30, 2014, an increase of $21.6 million or 2%. Our net income
for the year ended June 30, 2015 was $352.9 million or $2.47 per diluted share compared to net income of $345.3 million or $2.39 per diluted share
for the year ended June 30, 2014.
Total operating cash flow for fiscal year 2015 was $383.2 million and at June 30, 2015, our cash and cash equivalents totaled $717.2 million. At
June 30, 2015, our total assets were $2.2 billion and our stockholders’ equity was $1.6 billion. During fiscal year 2015, we repurchased 2.7 million
shares at a cost of $152.6 million under our share repurchase program, compared to 4.4 million shares at a cost of $208.1 million during fiscal year
2014. We paid a quarterly dividend of $0.28 per share during fiscal 2015 with a total amount of $157.3 million paid to stockholders.
In order to provide a framework for assessing how our underlying businesses performed, excluding the effect of foreign currency fluctuations, we
provide certain financial information on a “constant currency basis”, which is in addition to the actual financial information presented. In order to
calculate our constant currency information, we translate the current period financial information using the foreign currency exchange rates that were
in effect during the previous comparable period. However, constant currency measures should not be considered in isolation or as an alternative to
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U.S. dollar measures that reflect current period exchange rates, or to other financial measures calculated and presented in accordance with U.S.
generally accepted accounting principles.
Fiscal Year Ended June 30, 2015 Compared to Fiscal Year Ended June 30, 2014
Net Revenues. Net revenue increased for the year ended June 30, 2015 to $1,678.9 million from $1,555.0 million for the year ended June 30,
2014, an increase of $123.9 million or 8% (a 13% increase on a constant currency basis). The increase in net revenue was attributable to an increase
in unit sales of our flow generators, masks and accessories, partially offset by a decline in average selling prices. Movements in international
currencies against the U.S. dollar negatively impacted net revenues by approximately $74.5 million for the year ended June 30, 2015.
Net revenue in North and Latin America increased for the year ended June 30, 2015 to $962.7 million from $839.1 million for the year ended
June 30, 2014, an increase of $123.6 million or 15%. The increase in net revenue is primarily attributable to an increase in unit sales of our flow
generators, masks and accessories, partially offset by a decline in average selling prices.
Net revenue in markets outside North and Latin America increased for the year ended June 30, 2015 to $716.2 million from $715.8 million for the
year ended June 30, 2014, an increase of $0.4 million or 0% (a 10% increase on a constant currency basis). The constant currency increase in sales
outside North and Latin America predominantly reflects an increase in unit sales of our flow generators, masks and accessories, partially offset by a
decline in average selling prices.
Net revenue from flow generators for the year ended June 30, 2015 totaled $975.9 million from $846.7 million for the year ended June 30, 2014, an
increase of 15%, including an increase of 33% in North and Latin America and an increase of 2% outside North and Latin America (a 12% increase
on a constant currency basis). Net revenue from masks and other accessories for the year ended June 30, 2015 totaled $703.0 million from $708.3
million for the year ended June 30, 2014, a decrease of 1%, including an increase of 1% in North and Latin America and a decrease of 4% outside
North and Latin America (a 6% increase on a constant currency basis). Excluding the impact of foreign currency movements, flow generator sales
for the year ended June 30, 2015 increased by 21%, and masks and accessories sales increased by 3%, compared to the year ended June 30, 2014.
The following table summarizes the percentage movements in our net revenue for the year ended June 30, 2015 compared to the year ended June 30,
2014:
Flow generators
Masks and other accessories
Total
North and Latin
America
International
33%
1%
15%
2%
-4%
0%
Total
15%
-1%
8%
International
(Constant
Currency)*
Total
(Constant
Currency)*
12%
6%
10%
21%
3%
13%
*
Constant currency numbers exclude the impact of movements in international currencies.
Gross Profit. Gross profit increased for the year ended June 30, 2015 to $1,011.4 million from $989.8 million for the year ended June 30, 2014,
an increase of $21.6 million or 2%. Gross profit as a percentage of net revenue was 60.2% for the year ended June 30, 2015, compared with the
63.7% for the year ended June 30, 2014. The decline in gross margins was primarily due to declines in our average selling prices, an unfavorable
product mix as sales of our lower margin products represented a higher proportion of our sales, an unfavorable impact from exchange rate
movements as a result of the decline in the Euro currency relative to U.S. dollar, and an unfavorable geographic mix.
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Table of Contents
Selling, General and Administrative Expenses. Selling, general and administrative expenses increased for the year ended June 30, 2015 to
$478.6 million from $450.4 million for the year ended June 30, 2014, an increase of $28.2 million or 5%. The selling, general and administrative
expenses were favorably impacted by the movement of international currencies against the U.S. dollar, which decreased our expenses by
approximately $29.6 million, as reported in U.S. dollars. Excluding the impact of foreign currency movements, selling, general and administrative
expenses for the year ended June 30, 2015 increased by 13% compared to the year ended June 30, 2014. As a percentage of net revenue, selling,
general and administrative expenses for the year ended June 30, 2015 was 28.5%, compared to 29.0% for the year ended June 30, 2014.
The increase in selling, general and administrative expenses was primarily due to additional personnel to support our commercial activities, higher
marketing expenditure associated with our recent product releases, an increase in our variable employee compensation costs, the impact of recent
acquisitions, donations to the University of California – San Diego and ResMed Foundation, and the release of contingent consideration in the prior
year.
Research and Development Expenses. Research and development expenses decreased for the year ended June 30, 2015 to $114.9 million from
$118.2 million for the year ended June 30, 2014, a decrease of $3.4 million or 3%. The research and development expenses were favorably impacted
by the depreciation of the Australian dollar against the U.S. dollar, which decreased our expenses by approximately $11.0 million, as reported in U.S.
dollars. Excluding the impact of foreign currency movements, research and development expenses for the year ended June 30, 2015 increased by 6%
compared to the year ended June 30, 2014. As a percentage of net revenue, research and development expenses were 6.8% for the year ended
June 30, 2015 compared to 7.6% for the year ended June 30, 2014.
The increase in research and development expenses in constant currency terms was primarily due to an increase in the number of research and
development personnel and an increase in materials and tooling costs incurred to facilitate development of new products.
Amortization of Acquired Intangible Assets. Amortization of acquired intangible assets for the year ended June 30, 2015 totaled $8.7 million
compared to $9.7 million for the year ended June 30, 2014. The reduction in amortization expense was mainly attributable to certain acquired
intangibles reaching the end of their useful life and therefore being fully amortized.
Total other income, net. Total other income, net for the year ended June 30, 2015 was $26.7 million, compared with $26.0 million for the year
ended June 30, 2014. The increase in total other income, net, was due primarily due to gains on foreign currency transactions, partially offset by
lower interest income resulting from lower interest rates on cash balances held and the depreciation of the Australian dollar against the U.S. dollar.
Income Taxes. Our effective income tax rate decreased to 19.0% for the year ended June 30, 2015 from 19.9% for the year ended June 30, 2014.
Our effective income tax rate is affected by the geographic mix of our taxable income, including lower taxes associated with our Singapore and
Malaysia manufacturing operations. Our Singapore and Malaysia operations operate under certain tax holidays and tax incentive programs which
will expire in whole or in part at various dates through June 30, 2020. As of June 30, 2015, we have not provided for U.S. income taxes for the
undistributed earnings of our foreign subsidiaries. We intend for these earnings to be permanently reinvested outside the United States.
Net Income and Earnings per Share. As a result of the factors above, our net income for the year ended June 30, 2015 was $352.9 million
compared to net income of $345.3 million for the year ended June 30, 2014, an increase of 2% over the year ended June 30, 2014. As a result of the
increase in our
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net income and lower share count due to our stock repurchases, our earnings per share for the year ended June 30, 2015 was $2.47 per diluted share
compared to $2.39 per diluted share for the year ended June 30, 2014, an increase of 3% over the year ended June 30, 2014.
Fiscal Year Ended June 30, 2014 Compared to Fiscal Year Ended June 30, 2013
Net Revenues. Net revenue increased for the year ended June 30, 2014 to $1,555.0 million from $1,514.5 million for the year ended June 30,
2013, an increase of $40.5 million or 3%. The increase in net revenue was attributable to an increase in unit sales of our flow generators, masks and
accessories, partially offset by a decline in average selling prices. Movements in international currencies against the U.S. dollar positively impacted
net revenues by approximately $17.0 million for the year ended June 30, 2014. Excluding the impact of foreign currency movements, sales for the
year ended June 30, 2014 increased by 2% compared to the year ended June 30, 2013.
Net revenue in North and Latin America decreased for the year ended June 30, 2014 to $839.1 million from $851.6 million for the year ended
June 30, 2013, a decrease of $12.5 million or 1%. The decrease in net revenue was primarily attributable to increased competitor activity and a
decline in average selling prices, partially offset by an increase in unit sales of our flow generators, masks and accessories.
Net revenue in markets outside North and Latin America increased for the year ended June 30, 2014 to $715.8 million from $662.8 million for the
year ended June 30, 2013, an increase of $53.0 million or 8%. Movements in international currencies against the U.S. dollar favorably impacted
international revenues by approximately $17.0 million during the year ended June 30, 2014. Excluding the impact of foreign currency movements,
international sales for the year ended June 30, 2014 increased by 5%, compared to the year ended June 30, 2013. The increase in sales outside North
and Latin America predominantly reflected an increase in unit sales of our flow generators, masks and accessories.
Net revenue from flow generators for the year ended June 30, 2014 totaled $846.7 million from $823.5 million for the year ended June 30, 2013, an
increase of 3%, including an increase of 7% outside North and Latin America and a decrease of 2% in North and Latin America. Net revenue from
masks and other accessories totaled $708.3 million, an increase of 3%, including an increase of 10% outside North and Latin America and a 1%
decrease in North and Latin America, for the year ended June 30, 2014, compared to the year ended June 30, 2013.
The following table summarizes the percentage movements in our net revenue for the year ended June 30, 2014 compared to the year ended June 30,
2013:
Flow generators
Masks and other accessories
Total
North and Latin
America
International
Total
International
(Constant
Currency)*
Total
(Constant
Currency)*
-2%
-1%
-1%
7%
10%
8%
3%
3%
3%
5%
7%
5%
1%
2%
2%
*
Constant currency numbers exclude the impact of movements in international currencies.
Gross Profit. Gross profit increased for the year ended June 30, 2014 to $989.8 million from $940.7 million for the year ended June 30, 2013, an
increase of $49.1 million or 5%. Gross profit as a percentage of net revenue was 63.7% for the year ended June 30, 2014, compared with 62.1% for
the year ended June 30, 2013. The improvement in gross margins was primarily due to cost savings attributable to manufacturing and supply chain
improvements, favorable change in product mix as sales of our higher margin products represented a higher proportion of our sales, positive foreign
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currency impact due to the depreciation of the Australian dollar against the U.S. dollar and Euro, and a favorable geographic mix of sales, partially
offset by declines in our average selling prices.
Selling, General and Administrative Expenses. Selling, general and administrative expenses increased for the year ended June 30, 2014 to
$450.4 million from $430.8 million for the year ended June 30, 2013, an increase of $19.6 million or 5%. The selling, general and administrative
expenses were favorably impacted by the movement of international currencies against the U.S. dollar, which decreased our expenses by
approximately $4.6 million, as reported in U.S. dollars. Excluding the impact of foreign currency movements, selling, general and administrative
expenses for the year ended June 30, 2014 increased by 6% compared to the year ended June 30, 2013. As a percentage of net revenue, selling,
general and administrative expenses for the year ended June 30, 2014 was 29.0%, compared to 28.4% for the year ended June 30, 2013.
The increase in selling, general and administrative expenses was primarily due to an increase the number of sales and administrative personnel to
support our growth and other expenses related to the increase in our sales including activities targeted at increasing the awareness and diagnosis of
SDB, as well as an increase in our patent litigation expenses.
Research and Development Expenses. Research and development expenses decreased for the year ended June 30, 2014 to $118.2 million from
$120.1 million for the year ended June 30, 2013, a decrease of $1.9 million or 2%. The research and development expenses were favorably impacted
by the depreciation of the Australian dollar against the U.S. dollar, which decreased our expenses by approximately $9.0 million, as reported in U.S.
dollars. Excluding the impact of foreign currency movements, research and development expenses for the year ended June 30, 2014 increased by 6%
compared to the year ended June 30, 2013. As a percentage of net revenue, research and development expenses were 7.6% for the year ended
June 30, 2014 compared to 7.9% for the year ended June 30, 2013.
The increase in research and development expenses in constant currency terms was primarily due to an increase in the number of research and
development personnel, consulting and contractor expenses and an increase in materials and tooling costs incurred to facilitate development of new
products.
Amortization of Acquired Intangible Assets. Amortization of acquired intangible assets for the year ended June 30, 2014 totaled $9.7 million
compared to $10.1 million for the year ended June 30, 2013.
Restructuring expenses. During the year ended June 30, 2014 we completed a reorganization of our commercial and research and development
teams. As a result of this reorganization we terminated the employment of approximately 1% of our employees at a total cost of $6.3 million.
Total other income, net. Total other income, net for the year ended June 30, 2014 was $26.0 million, a decrease of $4.3 million compared with
$30.3 million for the year ended June 30, 2013. The decrease in total other income, net, was due primarily to lower interest income resulting from
lower interest rates on cash balances held, and the depreciation of the Australian dollar against the U.S. dollar, partially offset by gains on foreign
currency transactions.
Income Taxes . Our effective income tax rate was 19.9% for the year ended June 30, 2014 compared to 20.2% for the year ended June 30, 2013.
Our effective income tax rate is affected by the geographic mix of our taxable income, including lower taxes associated with our Singapore and
Malaysia manufacturing operations. Our Singapore and Malaysia operations operate under certain tax holidays and tax incentive programs which
will expire in whole or in part at various dates through June 30, 2020. As of June 30, 2014, we had not provided for U.S. income taxes for the
undistributed earnings of our foreign subsidiaries. We intend these earnings to be permanently reinvested outside the United States.
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Net Income and Earnings per Share. As a result of the factors above, our net income for the year ended June 30, 2014 was $345.3 million
compared to net income of $307.1 million for the year ended June 30, 2013, an increase of 12% over the year ended June 30, 2013. As a result of the
increase in our net income and lower share count due to our stock repurchases, our earnings per share for the year ended June 30, 2014 was $2.39 per
diluted share compared to $2.10 per diluted share for the year ended June 30, 2013, an increase of 14% over the year ended June 30, 2013.
Liquidity and Capital Resources
As of June 30, 2015 and June 30, 2014, we had cash and cash equivalents of $717.2 million and $905.7 million, respectively. Working capital was
$1.2 billion and $1.3 billion, at June 30, 2015 and June 30, 2014, respectively.
As of June 30, 2015 and June 30, 2014, our cash and cash equivalent balances held within the United States amounted to $32.0 million and $29.0
million, respectively. Our remaining cash and cash equivalent balances at June 30, 2015 and June 30, 2014, of $685.2 million and $876.7 million,
respectively, were held by our non-U.S. subsidiaries, indefinitely invested outside the United States. Our cash and cash equivalent balances are held
at highly rated financial institutions.
As of June 30, 2015, the cumulative amount of undistributed earnings from our foreign subsidiaries was approximately $1.4 billion, and those
undistributed earnings are considered permanently reinvested. We intend to reinvest the cash and cash equivalents of those entities whose
undistributed earnings are permanently reinvested in our international operations. We reassess our reinvestment assertions each reporting period and
currently believe that we have sufficient sources of liquidity to support our assertion that the undistributed earnings held by foreign subsidiaries may
be considered to be reinvested permanently. If these earnings had not been permanently reinvested, deferred taxes of approximately $364 million
would have been recognized in our consolidated financial statements.
We repatriated $130 million and $191 million to the U.S. in fiscal years 2015 and 2014, respectively, from earnings generated in each of those years.
The amount of the current year foreign earnings that we have repatriated to the U.S. in the past has been determined, and the amount that we expect
to repatriate during fiscal year 2016 will be determined, based on a variety of factors, including current year earnings of our foreign subsidiaries,
foreign investment needs and the cash flow needs we have in the U.S., such as for the repayment of debt, dividend distributions, and other domestic
obligations. The majority of our repatriation of foreign subsidiaries’ earnings to the U.S. has historically occurred at year-end, although we may
repatriate funds earlier in the year based on our business needs. When we repatriate funds to the U.S., we are required to pay taxes in the U.S. on
these amounts based on applicable U.S. tax rates, net of any foreign tax that would be allowed to be deducted or taken as a credit against U.S.
income tax. We paid $17.1 million and $10.7 million in additional U.S. federal income taxes in fiscal years 2015 and 2014, respectively, as a result
of repatriation of foreign earnings generated in those years.
Inventories at June 30, 2015 increased by $81.4 million or 49% to $246.9 million compared to June 30, 2014 inventories of $165.4 million. The
increase in inventories was due mainly to new product introductions and an increase in inventories held to support the increase in unit sales.
Accounts receivable, net of allowance for doubtful accounts, at June 30, 2015 were $362.6 million, an increase of $3.0 million or 1% over the
June 30, 2014 accounts receivable balance of $359.6 million. Accounts receivable days sales outstanding of 69 days at June 30, 2015 decreased by 7
days compared to 76 days at June 30, 2014. Our allowance for doubtful accounts as a percentage of total accounts receivable at June 30, 2015 and
2014 was 3.3% and 3.0%, respectively. The credit quality of our customers remains broadly consistent with our past experience.
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During the year ended June 30, 2015, we generated cash of $383.2 million from operations. This was slightly lower than the cash generated from
operations for the year ended June 30, 2014 of $391.3 million, which was primarily the result of the increase in our inventory balance. Movements in
foreign currency exchange rates during the year ended June 30, 2015 had the effect of decreasing our cash and cash equivalents by $172.8 million, as
reported in U.S. dollars. During fiscal years 2015 and 2014, we repurchased 2.7 million and 4.4 million shares at a cost of $152.6 million and $208.1
million, respectively. During fiscal years 2015 and 2014, we also paid dividends totaling $157.3 million and $141.5 million, respectively.
Details of contractual obligations at June 30, 2015 are as follows:
Payments Due by Fiscal Year
In $000’s
Long Term Debt
Interest on Long Term Debt
Operating Leases
Purchase Obligations
Total
2016
2017
- $
Total
$ 300,594 $
Thereafter
2019
- $
594
- $
- $ 300,000 $
4,199
21
1,419
29
12,293
12,910
5,349 3,817
-
-
156
12,908
$ 508,537 $ 155,098 $ 17,265 $ 12,652 $ 306,768 $ 3,846 $
4,199
16,915
133,984
14,066
59,737
134,140
4,199
8,453
-
-
2020
2018
Details of other commercial commitments at June 30, 2015 are as follows:
In $000’s
Standby Letter of Credit
Guarantees*
Total
Amount of Commitment Expiration Per Fiscal Year
Total
$ 7,713
$ 9,122
$ 16,835
2016
$
-
$ 179
$ 179
2018
2017
- $ 6,942
$
$ 127 $
-
$ 127 $ 6,942
2019
$ -
$ 2
$ 2
2020
$ -
$ 68
$ 68
Thereafter
771
8,746
9,517
$
$
$
The above guarantees mainly relate to requirements under contractual obligations with insurance companies transacting with our German subsidiaries and guarantees provided under our facility
*
leasing obligations.
Credit Facility
On October 31, 2013, we entered into a credit agreement, as borrower, with lenders, including Union Bank, N.A., as administrative agent, joint lead
arranger, swing line lender and letters of credit issuer, and HSBC Bank USA, National Association, as syndication agent and joint lead arranger. Our
obligations under the credit agreement are guaranteed by ResMed Corp. and ResMed Motor Technologies Inc., two of our U.S. subsidiaries.
The credit agreement provides a $700 million senior unsecured five-year revolving credit facility, with an uncommitted option to increase the credit
facility by an additional $300 million. The credit facility also includes a $25 million sublimit for letters of credit. The credit facility terminates on
October 31, 2018, when all unpaid principal and interest under the loans must be repaid. The outstanding principal amount due under the credit
facility will bear interest at a rate equal to LIBOR plus 1.0% to 2.0% (depending on the then-applicable leverage ratio). At June 30, 2015, the interest
rate that was being charged on the outstanding principal amount was 1.2%. An applicable commitment fee of 0.15% to 0.25% (depending on the
then-applicable leverage ratio) applies on the unused portion of the credit facility.
When we entered into the credit agreement, we used a portion of the proceeds from the initial funding of the credit facility to repay the outstanding
balance under our previous revolving credit facility with Union Bank, N.A and other lenders. On that repayment, the previous credit agreement,
dated as of February 10, 2011, between us and lenders (including Union Bank, N.A., as administrative agent,
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swing line lender and L/C Issuer, HSBC Bank USA, National Association, as syndication agent and Union Bank, N.A., HSBC Bank USA, National
Association, Commonwealth Bank of Australia and Wells Fargo Bank), was terminated and the commitments under the previous credit agreement
were also terminated.
Our obligations under the current credit agreement are unsecured but are guaranteed by two of our U.S. subsidiaries. The credit agreement contains
customary covenants, including certain financial covenants and an obligation that we maintain certain financial ratios, including a maximum
leverage ratio of funded debt to EBITDA (as defined in the credit agreement) and an interest coverage ratio. The entire principal amount of the credit
facility and any accrued but unpaid interest may be declared immediately due and payable if an event of default occurs, as defined in the credit
agreement. Events of default under the credit agreement include failure to make payments when due, the occurrence of a default in the performance
of any covenants in the credit agreement or related documents, or certain changes of control of ResMed Inc., ResMed Corp., ResMed Motor
Technologies Inc., ResMed Limited, ResMed Holdings Ltd/LLC or ResMed EAP Holdings LLC.
At June 30, 2015, we were in compliance with our debt covenants and there was $300.0 million outstanding under the credit agreement.
We expect to satisfy all of our liquidity requirements through a combination of cash on hand, cash generated from operations and debt facilities.
Tax Expense
Our income tax rate is governed by the laws of the regions in which our income is recognized. To date, a substantial portion of our income has been
subject to income tax in Australia where the statutory rate was 30% in fiscal years 2015, 2014, and 2013. During fiscal years 2015, 2014, and 2013,
our consolidated effective tax rate has fluctuated between approximately 19% and approximately 20%. These fluctuations have resulted from, and
future effective tax rates will depend on, numerous factors, including the amount of research and development expenditures for which an additional
Australian tax credit is available, the level of foreign earnings repatriated to the U.S., the geographic mix of taxable income and other tax credits or
benefits available to us under applicable tax laws, including the lower statutory tax rates and other incentives associated with our Singapore and
Malaysia manufacturing operations.
Critical Accounting Principles and Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make
estimates and judgments that affect our reported amounts of assets and liabilities, revenues and expenses and related disclosures of contingent assets
and liabilities. We evaluate our estimates on an ongoing basis, including those estimates related to allowance for doubtful accounts, inventory
adjustments, warranty obligations, goodwill, impaired assets, intangible assets, income taxes, deferred tax valuation allowances and stock-based
compensation costs.
We state these accounting policies in the Notes to the consolidated financial statements and at relevant sections in this discussion and analysis. The
estimates are based on the information that is currently available to us and on various other assumptions that we believe to be reasonable under the
circumstances. Actual results could vary from those estimates under different assumptions or conditions.
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We believe that the following critical accounting policies affect the more significant judgments and estimates used in the preparation of our
consolidated financial statements:
(1) Allowance for Doubtful Accounts. We maintain an allowance for doubtful accounts for estimated losses resulting from the inability of our
customers to make required payments, which results in bad debt expense. We determine the adequacy of this allowance by periodically evaluating
individual customer receivables, considering a customer’s financial condition, credit history and current economic conditions. If the financial
condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required.
(2) Inventory Adjustments. Inventories are stated at lower of cost or market and are determined by the first-in, first-out method. We review the
components of inventory on a regular basis for excess, obsolete and impaired inventory based on estimated future usage and sales. The likelihood of
any material inventory write-downs depends on changes in competitive conditions, new product introductions by us or our competitors, or rapid
changes in customer demand.
(3) Valuation of Goodwill, Intangible and Other Long-Lived Assets. We make assumptions in establishing the carrying value, fair value and
estimated lives of our goodwill, intangibles and other long-lived assets. The criteria used for these evaluations include management’s estimate of the
asset’s continuing ability to generate positive income from operations and positive cash flow in future periods compared to the carrying value of the
asset, as well as the strategic significance of any identifiable intangible asset in our business objectives. If assets are considered to be impaired, we
recognize as impairment the amount by which the carrying value of the assets exceeds their fair value. We base useful lives and related amortization
or depreciation expense on our estimate of the period that the assets will generate revenues or otherwise be used by us. Factors that would influence
the likelihood of a material change in our reported results include significant changes in the asset’s ability to generate positive cash flow, loss of legal
ownership or title to the asset, a significant decline in the economic and competitive environment on which the asset depends, significant changes in
our strategic business objectives, utilization of the asset, and a significant change in the economic and/or political conditions in certain countries.
We conducted our annual review for goodwill impairment during the final quarter of fiscal 2015 using a quantitative assessment. The results of our
annual review indicated that no impaired goodwill exists as the fair value for each reporting unit significantly exceeded its carrying value.
(4) Income Tax. We assess our income tax positions and record tax benefits for all years subject to examination based upon management’s
evaluation of the facts, circumstances, and information available at the reporting date. Where we determine that it is not more likely than not that we
would be able to realize all or part of our net deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to income
tax expense in the period such determination is made. Likewise, if we later determine that it is more likely than not that the net deferred tax assets
would be realized, the previously provided valuation allowance would be reversed. These changes to the valuation allowance, and resulting increases
or decreases in income tax expense, could have a material effect on our operating results.
Our income tax returns are based on calculations and assumptions that are subject to examination by various tax authorities. In addition, the
calculation of our tax liabilities involves dealing with uncertainties in the application of complex tax laws. Although currently immaterial, we
recognize liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by
determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including
resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50%
likely of being realized upon settlement. While we believe we have appropriate
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support for the positions taken on our tax returns, we regularly assess the potential outcomes of examinations by tax authorities in determining the
adequacy of our provision for income taxes, and adjust the income tax provision, income taxes payable and deferred taxes in the period in which the
facts that give rise to a revision become known.
(5) Provision for Warranty. We provide for the estimated cost of product warranties at the time the related revenue is recognized. We determine the
amount of this provision by using a financial model, which takes into consideration actual historical expenses and potential risks associated with our
different products. We use this financial model to calculate the future probable expenses related to warranty and the required level of the warranty
provision. Although we engage in product improvement programs and processes, our warranty obligation is affected by product failure rates and
costs incurred to correct those product failures. Should actual product failure rates or estimated costs to repair those product failures differ from our
estimates, we would be required to revise our estimated warranty provision.
(6) Revenue Recognition. We generally record revenue on product sales at the time of shipment, which is when title transfers to the customer. We
initially defer service revenue received in advance from service contracts and recognize that deferred revenue ratably over the life of the service
contract. We initially defer revenue we receive in advance from rental unit contracts and recognize that deferred revenue ratably over the life of the
rental contract. Otherwise, we recognize revenue from rental unit contracts ratably over the life of the rental contract. We include in revenue freight
charges we bill to customers. We charge all freight-related expenses to cost of sales. Taxes assessed by government authorities that are imposed on
and concurrent with revenue-producing transactions, such as sales and value added taxes, are excluded from revenue.
We do not normally offer a right of return or other recourse with respect to the sale of our products, other than returns for product defects or other
warranty claims. We do not recognize revenues if we offer a right of return or variable sale prices for subsequent events or activities. However, as
part of our sales processes we may provide upfront discounts for large orders, one-time special pricing to support new product introductions, sales
rebates for centralized purchasing entities or price-breaks for regular order volumes. We record the costs of all such programs as an adjustment to
revenue. Our products are predominantly therapy-based equipment and require no installation. Therefore, we have no significant installation
obligations.
For multiple-element arrangements, we allocate arrangement consideration to the deliverables by use of the relative selling price method. The selling
price used for each deliverable is based on vendor–specific objective evidence.
(7) Stock-Based Compensation. We measure the compensation cost of all stock-based awards at fair value on the date of grant. We recognize that
value as compensation expense over the service period, net of estimated forfeitures. We estimate the fair value of employee stock options and
purchase rights granted using a Black-Scholes valuation model. The fair value of an award is affected by our stock price on the date of grant as well
as other assumptions including the estimated volatility of our stock price over the term of the awards, the expected dividend per share and the
expected life of the awards. The risk-free interest rate assumption we use is based upon the U.S. Treasury yield curve at the time of grant appropriate
for the expected life of the awards. Expected volatilities are based on a combination of historical volatilities of our stock and the implied volatilities
from tradeable options of our stock corresponding to the expected term of the options. We use a combination of the historic and implied volatilities
as the addition of the implied volatility is more representative of our future stock price trends. While there is a tradeable market of options on our
common stock, less emphasis is placed on the implied volatility of these options due to the relative low volumes of these traded options and the
difference in the terms compared to our employee options. In order to determine the estimated period of time that we expect employees to hold their
stock options, we use historical rates
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by employee groups. The estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results differ from our
estimates, such amounts will be recorded as a cumulative adjustment in the period estimates are revised. The aforementioned inputs entered into the
Black-Scholes valuation model we use to fair value our stock awards are subjective estimates and changes to these estimates will cause the fair value
of our stock awards and related stock-based compensation expense we record to vary.
We estimate the fair value of restricted stock units based on the market value of the underlying shares as determined at the grant date less the fair
value of dividends that holders are not entitled to, during the vesting period. We estimate the weighted average grant date fair value of performance
restricted stock units, or PRSUs, which contain a market condition, using a Monte-Carlo simulation valuation model.
Recently Issued Accounting Pronouncements
See Note 3 – New Accounting Pronouncements to the consolidated financial statements for a description of recently issued accounting
pronouncements, including the expected dates of adoption and estimated effects on our results of operations, financial positions and cash flows.
Off-Balance Sheet Arrangements
As of June 30, 2015, we are not involved in any significant off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of Regulation S-K
promulgated by the SEC.
I TEM 7A
Q UANTITATIVE AND Q UALITATIVE D ISCLOSURES A BOUT M ARKET AND B USINESS R ISKS
Foreign Currency Market Risk
Our reporting currency is the U.S. dollar, although the financial statements of our non-U.S. subsidiaries are maintained in their respective local
currencies. We transact business in various foreign currencies, including a number of major European currencies as well as the Australian dollar. We
have significant foreign currency exposure through both our Australian and Singapore manufacturing activities and international sales operations.
We have established a foreign currency hedging program using purchased currency options and forward contracts to hedge foreign-currency-
denominated financial assets, liabilities and manufacturing cash flows. The goal of this hedging program is to economically manage the financial
impact of foreign currency exposures predominantly denominated in euros, Australian dollars and Singapore dollars. Under this program, increases
or decreases in our foreign-currency-denominated financial assets, liabilities, and firm commitments are partially offset by gains and losses on the
hedging instruments. We do not enter into financial instruments for trading or speculative purposes. The foreign currency derivatives portfolio is
recorded in the consolidated balance sheets at fair value and included in other assets or other liabilities. All movements in the fair value of the
foreign currency derivatives are recorded within other income, net, on our consolidated statements of income.
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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, 2015 (in thousands):
AUD Functional:
Assets
Liability
Foreign Currency Hedges
Net Total
USD Functional:
Assets
Liability
Foreign Currency Hedges
Net Total
EURO Functional:
Assets
Liability
Foreign Currency Hedges
Net Total
GBP Functional:
Assets
Liability
Foreign Currency Hedges
Net Total
SGD Functional :
Assets
Liability
Foreign Currency Hedges
Net Total
Australian
Dollar
(AUD)
U.S.
Dollar
(USD)
Euro
(EUR)
Singapore
Dollar
(SGD)
Canadian
Dollar
(CAD)
Swiss
Franc
(CHF)
Malaysian
Ringgit
(MYR)
-
-
-
-
257,678
(26,755)
171,595
(54,799)
(220,000)
(133,788)
(675)
(88)
-
10,923
(16,992)
(763)
-
-
-
-
284
(4,102)
-
(3,818)
256
(248)
-
8
178,150
(98,493)
(70,000)
9,657
-
(2,001)
-
(2,001)
8
-
-
8
-
-
-
-
910
(1,014)
-
(104)
- 49 -
-
-
-
-
-
-
-
-
40,137
(38,138)
-
1,999
56,330
(39,396)
(22,298)
(5,364)
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
1
-
-
1
-
(1,071)
-
(1,071)
15,307
(1,042)
(9,609)
4,656
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
4,398
(30)
-
4,368
-
-
-
-
-
-
-
-
2,229
-
-
2,229
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
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The table below provides information about our foreign currency derivative financial instruments and presents the information in U.S. dollar
equivalents. 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, 2015. The table presents the notional amounts and weighted average
exchange rates by contractual maturity dates for our foreign currency derivative financial instruments. These notional amounts generally are used to
calculate payments to be exchanged under the options contracts (in thousands, except exchange rates):
Foreign Exchange
Contracts
Receive AUD/Pay USD
Contract amount
Ave. contractual
exchange rate
Receive AUD/Pay Euro
Contract amount
Ave. contractual
exchange rate
Receive SGD/Pay Euro
Contract amount
Ave. contractual
exchange rate
Receive SGD/Pay USD
Contract amount
Ave. contractual
exchange rate
Receive GBP/Pay AUD
Contract amount
Ave. contractual
exchange rate
Receive EUR/Pay GBP
Contract amount
Ave. contractual
exchange rate
Receive AUD/Pay CNY
Contract amount
Ave. contractual
exchange rate
Receive USD/Pay CAD
Contract amount
Ave. contractual
exchange rate
FY 2016
220,000
FY 2017
-
FY 2018
-
Total
220,000
AUD 1 = USD 0.7709
AUD 1 = USD 0.7709
Fair Value
Assets /
(Liabilities)
June 30,
2015
June 30,
2014
(649)
328
178,000
45,000
11,000
234,000
2,094
(2,574)
AUD 1 = Euro 0.6965
AUD 1 = Euro 0.7200 AUD 1 = Euro 0.7100 AUD 1 = Euro 0. 7015
22,000
SGD 1 = Euro 0. 6644
70,000
SGD 1 = USD 0.7454
13,000
GBP 1 = AUD 0.4871
5,000
EUR 1 = GBP 0.7134
3,000
AUD 1 = CNY 4.8800
10,000
USD 1 = CAD 1.2482
-
-
-
-
-
-
- 50 -
-
-
-
-
-
-
22,000
52
(90)
SGD 1 = Euro 0. 6644
70,000
(276)
SGD 1 = USD 0.7454
13,000
(96)
59
18
GBP 1 = AUD 0.4871
5,000
(26)
(11)
EUR 1 = GBP 0.7134
3,000
(66)
AUD 1 = CNY 4.8800
10,000
5
USD 1 = CAD 1.2482
-
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Interest Rate Risk
We are exposed to risk associated with changes in interest rates affecting the return on our cash and cash equivalents and debt. At June 30, 2015, we
maintained cash and cash equivalents of $717.2 million principally comprised 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, 2015, we had total long-term debt, including the current portion of those
obligations, of $300.6 million of which, $300.0 million is subject to variable interest rates. A hypothetical 10% change in interest rates during the
year ended June 30, 2015, would not have had a material impact on pretax income. We have no interest rate hedging agreements.
I TEM 8
C ONSOLIDATED F INANCIAL S TATEMENTS AND S UPPLEMENTARY D ATA
The information required by this Item is incorporated by reference to the financial statements set forth in Item 15 of Part IV of this report, “Exhibits
and Consolidated Financial Statement Schedules.”
a)
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of June 30, 2015 and 2014
Consolidated Statements of Income for the years ended June 30, 2015, 2014 and 2013
Consolidated Statements of Comprehensive Income for the years ended June 30, 2015, 2014 and 2013
Consolidated Statements of Stockholders’ Equity for the years ended June 30, 2015, 2014 and 2013
Consolidated Statements of Cash Flows for the years ended June 30, 2015, 2014 and 2013
Notes to Consolidated Financial Statements
Schedule II – Valuation and Qualifying Accounts and Reserves
F1
F2
F3
F4
F5
F6
F7
b)
Supplementary Data
Quarterly Financial Information (unaudited) – The quarterly results for the years ended June 30, 2015 and 2014 are summarized below
(in thousands, except per share amounts):
Net revenues
Gross profit
Net income
Basic earnings per share
Diluted earnings per share
2015
2014
Net revenues
Gross profit
Net income
First
Quarter
$ 380,399
237,313
83,260
0.59
0.58
First
Quarter
$ 357,662
227,982
80,930
Second
Quarter
$ 422,952
263,222
91,181
0.65
0.64
Second
Quarter
$ 384,341
248,759
86,636
Third
Quarter
Fourth
Quarter
$ 422,497 $ 453,064
259,430
251,431
87,462
90,983
0.65
0.64
0.62
0.61
Third
Quarter
Fourth
Quarter
$ 397,758 $ 415,211
261,258
251,788
87,738
89,969
Fiscal Year
$ 1,678,912
1,011,396
352,886
2.51
2.47
Fiscal Year
$ 1,554,973
989,786
345,273
Basic earnings per share
Diluted earnings per share
2.44
2.39
Note: the amounts for each quarter are computed independently, and, due to the computation formula, the sum of the four quarters may not equal the
year.
0.61
0.60
0.57
0.56
0.64
0.63
0.62
0.61
I TEM 9
C HANGES IN AND D ISAGREEMENTS WITH A CCOUNTANTS ON A CCOUNTING AND F INANCIAL D ISCLOSURE
None.
- 51 -
Table of Contents
I TEM 9A
C ONTROLS AND P ROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is
recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and
that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as
appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures,
management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible
controls and procedures.
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, 2015. 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, 2015.
There has been no change in our internal controls over financial reporting during our most recent fiscal quarter that has materially affected, or is
reasonably likely to materially affect, our internal controls over financial reporting.
- 52 -
Table of Contents
M ANAGEMENT ’ S R EPORT ON I NTERNAL C ONTROL O VER F INANCIAL R EPORTING
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and
15d-15(f) under the Securities Exchange Act of 1934. Our internal control over financial reporting is designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles in the United States of America. Our internal control over financial reporting includes those policies and procedures that:
(i)
(ii)
(iii)
Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with
generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of
our management and directors; and
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that
could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any
evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the
degree of compliance with the policies or procedures may deteriorate.
Management assessed the effectiveness of our internal control over financial reporting as of June 30, 2015. In making this assessment, management
used the framework in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the
operational effectiveness of its internal control over financial reporting. Management reviewed the results of its assessment with the audit committee
of our board of directors.
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, 2015.
KPMG LLP, independent registered public accounting firm, who audited and reported on the consolidated financial statements of ResMed, Inc.
included in this report, has issued an attestation report on the effectiveness of internal control over financial reporting.
- 53 -
Table of Contents
The Board of Directors and Stockholders
ResMed Inc.:
R EPORT OF I NDEPENDENT R EGISTERED P UBLIC A CCOUNTING F IRM
We have audited the internal control over financial reporting of ResMed Inc. as of June 30, 2015, based on criteria established in Internal
Control
–
Integrated
Framework
(2013)
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The management of ResMed Inc. 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 Management’s
Report
on
Internal
Control
Over
Financial
Reporting
. Our responsibility is to express an opinion on the internal control over
financial reporting of ResMed Inc. based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our
audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating
the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered
necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial
reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions
and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with
authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with
the policies or procedures may deteriorate.
In our opinion, ResMed Inc. maintained, in all material respects, effective internal control over financial reporting as of June 30, 2015, based on criteria established
in Internal
Control
–
Integrated
Framework
(2013)
issued by COSO.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of
ResMed Inc. and subsidiaries as of June 30, 2015 and 2014, and 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, 2015, and the related financial statement schedule, and our report dated August 6, 2015
expressed an unqualified opinion on those consolidated financial statements and financial statement schedule.
/s/ KPMG LLP
San Diego, California
August 6, 2015
I TEM 9B
O THER I NFORMATION
None.
- 54 -
Table of Contents
PART III
I TEM 10
D IRECTORS , E XECUTIVE O FFICERS AND C ORPORATE G OVERNANCE
Information required by this Item is incorporated by reference from our definitive proxy statement for our November 19, 2015, annual meeting of
stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, 2015.
We have filed as exhibits to this annual report on Form 10-K for the year ended June 30, 2015, the certifications of our chief executive officer and
chief financial officer required by Section 302 of the Sarbanes-Oxley Act of 2002.
I TEM 11
E XECUTIVE C OMPENSATION
Information required by this Item is incorporated by reference from our definitive proxy statement for our November 19, 2015, annual meeting of
stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, 2015.
I TEM 12
S ECURITY O WNERSHIP OF C ERTAIN B ENEFICIAL O WNERS AND M ANAGEMENT AND R ELATED S TOCKHOLDER M ATTERS
Information required by this Item is incorporated by reference from our definitive proxy statement for our November 19, 2015, annual meeting of
stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, 2015.
I TEM 13
C ERTAIN R ELATIONSHIPS AND R ELATED T RANSACTIONS , AND D IRECTOR I NDEPENDENCE
Information required by this Item is incorporated by reference from our definitive proxy statement for our November 19, 2015, annual meeting of
stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, 2015.
I TEM 14
P RINCIPAL A CCOUNTING F EES AND S ERVICES
Information required by this Item is incorporated by reference from our definitive proxy statement for our November 19, 2015, annual meeting of
stockholders, which will be filed with the Securities and Exchange Commission within 120 days after June 30, 2015.
- 55 -
Table of Contents
I TEM 15
E XHIBITS AND C ONSOLIDATED F INANCIAL S TATEMENT S CHEDULES
The following documents are filed as part of this report:
PART IV
(a)
(b)
3.1
3.2
4.1
10.1
10.2*
10.3*
10.4*
10.5*
10.6*
10.7*
10.8*
10.9
10.10
Consolidated Financial Statements and Schedules – The index to our consolidated financial statements and schedules are set forth in the “Index to
Consolidated Financial Statements” under Item 8 of this report.
Exhibit Lists
First Restated Certificate of Incorporation of ResMed Inc., as amended.
(16)
Fifth Amended and Restated Bylaws of ResMed Inc.
(13)
Form of certificate evidencing shares of Common Stock.
(1)
Licensing Agreement between the University of Sydney and ResMed Ltd dated May 17, 1991, as amended.
(1)
ResMed Inc. 2006 Incentive Award Plan.
(6)
Amendment No. 1 to the ResMed Inc. 2006 Incentive Award Plan.
(3)
2006 Grant agreement for Board of Directors.
(3)
2006 Grant agreement for Executive Officers.
(5)
2006 Grant agreement for Australian Executive Officers.
(5)
Form of Executive Agreement.
(4)
Amended and Restated 2006 Incentive Award Plan dated November 20, 2008.
(7)
Form of Indemnification Agreements for our directors and officers.
(8)
Form of Access Agreement for directors.
(8)
10.11*
Updated Form of Executive Agreement.
(2)(12)
10.12
10.13
10.14
10.15
10.16
10.17
10.18
10.19
10.20
ResMed Inc. 2009 Incentive Award Plan.
(9)
ResMed Inc. 2009 Employee Stock Purchase Plan.
(9)
Amendment No. 1 to the ResMed Inc. 2009 Employee Stock Purchase Plan
(14)
Form of Restricted Stock Award Agreement.
(9)
ResMed Inc. Deferred Compensation Plan.
(10)
Credit Agreement, dated as of October 31, 2013, among ResMed Inc., the lenders Union Bank, N.A., as administrative agent, joint lead arranger,
swing line lender and letters of credit issuer and HSBC Bank USA, National Association, as syndication agent and joint lead arranger.
(17)
Unconditional Guaranty entered into as of October 31, 2013, by each of ResMed Corp. and
ResMed Motor Technologies Inc., in favor of Union Bank, N.A., as administrative agent.
(17)
Form of Restricted Stock Unit Award Agreement for Executive Officers.
(11)
Form of Restricted Stock Unit Award Agreement for Directors.
(11)
- 56 -
Table of Contents
10.21
10.22
10.23
21.1
23.1
31.1
31.2
32.1
101
Form of Stock Option Grant for Executive Officers.
(11)
Form of Stock Option Grant for Directors.
(11)
Form of Performance-Based Restricted Stock Unit Award Agreement for Executive Officers.
(15)
Subsidiaries of the Registrant.
(18)
Consent of Independent Registered Public Accounting Firm.
(18)
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
(18)
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
(18)
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
(18)
The following materials from ResMed Inc.’s Annual Report on Form 10-K for the fiscal year ended June 30, 2015 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 and Statements of Cash Flows and (v) related notes.
* Management contract or compensatory plan or arrangement
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
Incorporated by reference to the Registrant’s Registration Statement on Form S-1 (No. 33-91094) declared effective on June 1, 1995.
Incorporated by reference to the Registrant’s Report on Form 10-K for the year ended June 30, 2009.
Incorporated by reference to the Registrant’s Report on Form 10-Q for the quarter ended December 31, 2006.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on July 13, 2007.
Incorporated by reference to the Registrant’s Report on Form 10-K for the year ended June 30, 2007.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on November 15, 2006.
Incorporated by reference to Appendix A of the Registrant’s Definitive Proxy Statement filed on October 15, 2008.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on June 24, 2009.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on November 23, 2009.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on May 25, 2010.
Incorporated by reference to the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2011.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on July 2, 2012.
Incorporated by reference to the Registrant’s Report on Form 8-K/A filed on September 17, 2012.
Incorporated by reference to Appendix A of the Registrant’s Definitive Proxy Statement filed on October 4, 2012.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on November 21, 2012.
Incorporated by reference to Exhibit 3.1 to the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2013
Incorporated by reference to Exhibits 10.1 and 10.2 to the Registrant’s Report on Form 8-K filed on November 5, 2013
Filed with this report.
- 57 -
Table of Contents
The Board of Directors and Stockholders
ResMed Inc.:
R EPORT OF I NDEPENDENT R EGISTERED P UBLIC A CCOUNTING F IRM
We have audited the accompanying consolidated balance sheets of ResMed Inc. and subsidiaries (the Company) as of June 30, 2015 and 2014, and 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, 2015.
In connection with our audits of the consolidated financial statements, we also have audited financial statement schedule II. These consolidated financial statements
and financial statement schedule are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial
statements and financial statement schedule based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we
plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on
a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of ResMed Inc. and subsidiaries
as of June 30, 2015 and 2014, and the results of their operations and their cash flows for each of the years in the three-year period ended June 30, 2015, in
conformity with U.S. generally accepted accounting principles. Also in our opinion, the related financial statement schedule, when considered in relation to the
basic consolidated financial statements taken as a whole, presents fairly, in all material respects, the information set forth therein.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control over
financial reporting as of June 30, 2015, based on criteria established in Internal
Control-Integrated
Framework
(2013)
issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO), and our report dated August 6, 2015, expressed an unqualified opinion on the effectiveness of the internal
control over financial reporting of ResMed Inc.
/s/ KPMG LLP
San Diego, California
August 6, 2015
- F1 -
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Consolidated Balance Sheets
June 30, 2015 and 2014
(In thousands, except share and per share data)
Assets
Current assets:
Cash and cash equivalents
Accounts receivable, net of allowance for doubtful accounts of $12,276 and $10,971 at June 30, 2015 and June 30, 2014,
respectively
Inventories (note 5)
Deferred income taxes (note 14)
Prepaid expenses and other current assets
Total current assets
Non-current assets:
Property, plant and equipment, net (note 6)
Goodwill and other intangible assets, net (note 7)
Deferred income taxes (note 14)
Other assets
Total non-current assets
Total assets
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
Accrued expenses (note 9)
Deferred revenue
Income taxes payable
Deferred income taxes (note 14)
Current portion of long-term debt (note 11)
Total current liabilities
Non-current liabilities:
Deferred income taxes (note 14)
Deferred revenue
Long-term debt (note 11)
Income taxes payable
Total non-current liabilities
Total liabilities
Commitments and contingencies (notes 18 and 19)
Stockholders’ equity: (note 12)
Preferred stock, $0.01 par value, 2,000,000 shares authorized; none issued
Common stock, $0.004 par value, 350,000,000 shares authorized; 179,660,939 issued and 140,474,705 outstanding at June 30,
2015 and 176,747,039 issued and 140,304,544 outstanding at June 30, 2014
Additional paid-in capital
Retained earnings
Treasury stock, at cost, 39,186,234 shares at June 30, 2015, and 36,442,495 shares at June 30, 2014
Accumulated other comprehensive (loss) income
Total stockholders’ equity
Total liabilities and stockholders’ equity
See accompanying notes to consolidated financial statements.
- F2 -
June 30,
2015
June 30,
2014
$
717,249
$
905,730
362,568
246,859
36,338
81,168
359,593
165,418
31,908
93,560
1,444,182
1,556,209
387,758
311,403
12,528
28,389
434,277
334,510
18,755
17,211
740,078
804,753
$ 2,184,260
$ 2,360,962
$
81,112
132,976
36,097
16,278
796
-
$
85,405
130,656
42,370
10,392
717
18
267,259
269,558
8,062
19,284
300,594
1,754
10,716
16,352
300,770
5,318
329,694
333,156
596,953
602,714
-
-
562
1,228,795
1,976,020
(1,444,554)
(173,516)
561
1,117,644
1,780,396
(1,291,910)
151,557
1,587,307
1,758,248
$ 2,184,260
$ 2,360,962
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Consolidated Statements of Income
Years Ended June 30, 2015, 2014 and 2013
(In thousands, except per share data)
Net revenue
Cost of sales (excluding amortization of acquired intangible assets)
Gross profit
Operating expenses:
Selling, general and administrative
Research and development
Restructuring expenses (note 23)
Education, research and settlement charge (note 23)
Amortization of acquired intangible assets
Total operating expenses
Income from operations
Other income, net:
Interest income
Interest expense
Other, net (note 13)
Total other income, net
Income before income taxes
Income taxes (note 14)
Net income
Basic earnings per share
Diluted earnings per share (note 4)
Dividend declared per share
Basic shares outstanding (000’s)
Diluted shares outstanding (000’s)
See accompanying notes to consolidated financial statements.
- F3 -
June 30,
2015
June 30,
2014
June 30,
2013
$ 1,678,912
667,516
$ 1,554,973
565,187
$ 1,514,457
573,800
1,011,396
989,786
940,657
478,627
114,865
-
-
8,668
450,414
118,226
6,326
-
9,733
430,802
120,124
-
24,765
10,142
602,160
584,699
585,833
409,236
405,087
354,824
26,208
(5,778)
6,250
31,236
(6,129)
884
38,873
(6,387)
(2,191)
26,680
25,991
30,295
435,916
83,030
431,078
85,805
$ 352,886
$ 345,273
$
$
$
2.51
2.47
1.12
140,468
142,687
$
$
$
2.44
2.39
1.00
141,474
144,359
385,119
77,986
307,133
2.15
2.10
0.68
142,954
146,410
$
$
$
$
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Consolidated Statements of Comprehensive Income
Years Ended June 30, 2015, 2014 and 2013
(In US$ thousands)
Net income
Other comprehensive (loss) income:
Foreign currency translation (loss) gain adjustments
Comprehensive income
See accompanying notes to consolidated financial statements.
- F4 -
Years Ended June 30,
2015
2014
2013
$ 352,886
$ 345,273
$ 307,133
(325,073)
59,469
(144,368)
$ 27,813
$ 404,742
$ 162,765
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Consolidated Statements of Stockholders’ Equity
Years ended June 30, 2015, 2014 and 2013
(In thousands)
Balance, June 30, 2012
Common stock issued on exercise of options (note 12)
Common stock issued on vesting of restricted stock units, net of shares withheld for tax (note
12)
Common stock issued on employee stock purchase plan (note 12)
Treasury stock purchases
Tax benefit from exercise of options
Stock-based compensation costs
Other comprehensive income
Net income
Dividends declared
Common Stock Additional
Treasury Stock
Paid-in
Capital
Shares Amount
169,753 $
3,433
14
Shares Amount
568 $ 899,717 (27,732) $ (895,826) $ 1,366,712 $
Total
236,456 $ 1,607,627
65,649
Accumulated
Other
Comprehensive
Income (Loss)
Retained
Earnings
529
324
2
1
(17)
65,635
(7,180)
10,451
(4,294)
(188,019)
18,215
38,226
(7,178)
10,452
(188,036)
18,215
38,226
(144,368)
307,133
(97,204)
(144,368)
307,133
(97,204)
Balance, June 30, 2013
Common stock issued on exercise of options (note 12)
Common stock issued on vesting of restricted stock units, net of shares withheld for tax (note
174,039 $
1,681
568 $ 1,025,064 (32,026) $(1,083,845) $ 1,576,641 $
7
31,157
92,088 $ 1,610,516
31,164
12)
Common stock issued on employee stock purchase plan (note 12)
Treasury stock purchases
Tax benefit from exercise of options
Stock-based compensation costs
Other comprehensive income
Net income
Dividends declared
713
314
3
1
(18)
(11,302)
13,052
(4,416)
(208,065)
16,211
43,462
(11,299)
13,053
(208,083)
16,211
43,462
59,469
345,273
(141,518)
59,469
345,273
(141,518)
Balance, June 30, 2014
Common stock issued on exercise of options (note 12)
Common stock issued on vesting of restricted stock units, net of shares withheld for tax (note
176,747 $
1,954
561 $ 1,117,644 (36,442) $(1,291,910) $ 1,780,396 $
8
36,565
151,557 $ 1,758,248
36,573
12)
Common stock issued on employee stock purchase plan (note 12)
Treasury stock purchases
Tax benefit from exercise of options
Stock-based compensation costs
Other comprehensive income
Net income
Dividends declared
651
309
3
1
(11)
(11,406)
13,412
(2,744)
(152,644)
24,868
47,712
(11,403)
13,413
(152,655)
24,868
47,712
(325,073)
352,886
(157,262)
(325,073)
352,886
(157,262)
Balance, June 30, 2015
179,661 $
562 $ 1,228,795 (39,186) $(1,444,554) $ 1,976,020 $
(173,516) $ 1,587,307
See accompanying notes to consolidated financial statements.
- F5 -
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Consolidated Statements of Cash Flows
Years ended June 30, 2015, 2014 and 2013
(In thousands)
Cash flows from operating activities:
Net income
Adjustment to reconcile net income to net cash provided by operating activities:
Depreciation and amortization
Stock-based compensation costs
Impairment of cost-method investments
Changes in fair value of business combination contingent consideration
Gain on disposal of business
Excess tax benefit from stock-based compensation arrangements
Changes in operating assets and liabilities, net of effect of acquisitions:
Accounts receivable, net
Inventories, net
Prepaid expenses, net deferred income taxes and other current assets
Accounts payable, accrued expenses and other liabilities
Net cash provided by operating activities
Cash flows from investing activities:
Purchases of property, plant and equipment
Patent registration costs
Business acquisitions, net of cash acquired
Investments in cost-method investments
Proceeds from disposal of cost-method investments
Purchases of foreign currency contracts
(Payment)/proceeds on maturity of foreign currency contracts
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from issuance of common stock, net
Excess tax benefit from stock-based compensation arrangements
Purchases of treasury stock
Payment of business combination contingent consideration
Proceeds from borrowings, net of borrowing costs
Repayment of borrowings
Dividends paid
Net cash used in financing activities
Effect of exchange rate changes on cash
Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
Supplemental disclosure of cash flow information:
Income taxes paid, net of refunds
Interest paid
Fair value of assets acquired, excluding cash
Liabilities assumed
Goodwill on acquisition
Deferred payments
Fair value of contingent consideration
Cash paid for acquisition
See accompanying notes to consolidated financial statements.
- F6 -
June 30,
2015
June 30,
2014
June 30,
2013
$ 352,886
$ 345,273
$ 307,133
73,056
47,855
-
(132)
(709)
(24,959)
(28,259)
(99,524)
(22,849)
85,815
73,454
43,457
-
(6,283)
-
(16,335)
(35,108)
(15,851)
5,814
(3,153)
78,280
38,157
475
(1,827)
-
(18,307)
(37,267)
27,143
(28,678)
37,714
383,180
391,268
402,823
(62,502)
(9,442)
(29,407)
(10,750)
937
(700)
(31,207)
(72,722)
(8,434)
(3,852)
(10,850)
-
(1,477)
2,348
(63,579)
(8,203)
(5,418)
(2,225)
-
(1,117)
2,542
(143,071)
(94,987)
(78,000)
38,806
24,959
(160,300)
(458)
180,000
(181,536)
(157,262)
33,354
16,335
(202,169)
(1,117)
557,834
(560,035)
(141,518)
69,239
18,307
(186,258)
(7,790)
150,000
(100,221)
(97,204)
(255,791)
(297,316)
(153,927)
(172,799)
30,717
(104,389)
(188,481)
905,730
29,682
876,048
66,507
809,541
$ 717,249
$ 905,730
$ 876,048
$
$
$
48,533
5,778
20,408
(8,528)
20,947
(1,703)
(1,717)
$
$
$
90,183
6,129
2,257
(829)
3,227
(803)
-
$
$
$
85,724
6,387
5,970
(2,278)
13,876
-
(12,150)
$
29,407
$
3,852
$
5,418
Table of Contents
(1)
Organization and Basis of Presentation
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
ResMed Inc. (referred to herein as “we”, “us”, “our” or the “Company”) is a Delaware corporation formed in March 1994 as a holding company for the
ResMed Group. Through our subsidiaries, we design, manufacture and market equipment for the diagnosis and treatment of sleep-disordered breathing and
other respiratory disorders, including obstructive sleep apnea. Our manufacturing operations are located in Australia, Singapore, France, Germany, Malaysia
and the United States. Major distribution and sales sites are located in the United States, Germany, France, the United Kingdom, Switzerland, Australia,
Japan, Norway and Sweden.
(2)
Summary of Significant Accounting Policies
(a)
Basis of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant inter-company
transactions and balances have been eliminated in consolidation.
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management
estimates and assumptions that affect amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ
from management’s estimates.
(b)
Revenue Recognition
We generally record revenue on product sales at the time of shipment, which is when title transfers to the customer. We do not record revenue on
product sales which require customer acceptance until we receive acceptance. We initially defer service revenue received in advance from service
contracts and recognize that deferred revenue ratably over the life of the service contract. We initially defer revenue we receive in advance from rental
unit contracts and recognize that deferred revenue ratably over the life of the rental contract. Otherwise, we recognize revenue from rental unit
contracts ratably over the life of the rental contract. We include in revenue freight charges we bill to customers. We charge all freight-related expenses
to cost of sales. Taxes assessed by government authorities that are imposed on and concurrent with revenue-producing transactions, such as sales and
value added taxes, are excluded from revenue.
We do not recognize revenues to the extent that we offer a right of return or other recourse with respect to the sale of our products, other than returns
for product defects or other warranty claims, nor do we recognize revenues if we offer variable sale prices for subsequent events or activities.
However, as part of our sales processes we may provide upfront discounts for large orders, one-time special pricing to support new product
introductions, sales rebates for centralized purchasing entities or price-breaks for regular order volumes. We record the costs of all such programs as
an adjustment to revenue. Our products are predominantly therapy-based equipment and require no installation. Therefore, we have no installation
obligations.
For multiple-element arrangements, we allocate arrangement consideration to the deliverables by use of the relative selling price method. The selling
price used for each deliverable is based on vendor–specific objective evidence.
- F7 -
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
(2)
Summary of Significant Accounting Policies, Continued
(c)
Cash and Cash Equivalents
Cash equivalents include certificates of deposit and other highly liquid investments and we state them at cost, which approximates market. We
consider investments with original maturities of 90 days or less to be cash equivalents for purposes of the consolidated statements of cash flows.
Our cash and cash equivalents balance at June 30, 2015, include $402.4 million in cash which is subject to notice periods of up to 90 days. These cash
balances earn interest rates above normal term deposit rates otherwise available and are held at highly rated financial institutions.
(d)
Inventories
We state inventories at the lower of cost (determined principally by the first-in, first-out method) or net realizable value. We include material, labor
and manufacturing overhead costs in finished goods and work-in-process inventories. We review and provide for any product obsolescence in our
manufacturing and distribution operations by assessing throughout the year individual products and components (based on estimated future usage and
sales).
(e)
Property, Plant and Equipment
We record property, plant and equipment, including rental and demonstration equipment at cost. We compute depreciation expense using the straight-
line method over the estimated useful lives of the assets. Useful lives are generally two to ten years except for buildings which are depreciated over an
estimated useful life of 40 years and leasehold improvements, which we amortize over the lease term. We charge maintenance and repairs to expense
as we incur them.
(f)
Intangible Assets
We capitalize the registration costs for new patents and amortize the costs over the estimated useful life of the patent, which is generally five years. If
a patent is superseded or a product is retired, any unamortized costs are written off immediately.
We amortize all of our other intangible assets on a straight-line basis over their estimated useful lives, which range from two to nine years. We
evaluate the recoverability of intangible assets periodically and take into account events or circumstances that warrant revised estimates of useful lives
or that indicate that impairment exists. We have not identified any impairment of intangible assets during any of the periods presented.
(g)
Goodwill
We conducted our annual review for goodwill impairment during the final quarter of fiscal 2015 using a quantitative assessment. In conducting our
review of goodwill impairment, we identified 8 reporting units, being components of our operating segment. The fair value for each reporting unit was
determined based on estimated discounted cash flows. Our goodwill impairment review involved a two-step process as follows:
Step 1-
Compare the fair value for each reporting unit to its carrying value, including goodwill. For each reporting unit where the carrying value,
including goodwill, exceeds the reporting unit’s fair value, move on to step 2. If a reporting unit’s fair value exceeds the carrying value,
no further work is performed and no impairment charge is necessary.
- F8 -
Table of Contents
(2)
Summary of Significant Accounting Policies, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
Step 2-
Allocate the fair value of the reporting unit to its identifiable tangible and non-goodwill intangible assets and liabilities. This will derive
an implied fair value for the goodwill. Then, compare the implied fair value of the reporting unit’s goodwill with the carrying amount of
the reporting unit’s goodwill. If the carrying amount of the reporting unit’s goodwill is greater than the implied fair value of its goodwill,
an impairment loss must be recognized for the excess.
The results of Step 1 of our annual review indicated that no impaired goodwill exists as the fair value for each reporting unit significantly exceeded its
carrying value.
(h)
Foreign Currency
The consolidated financial statements of our non-U.S. subsidiaries, whose functional currencies are other than the U.S. dollar, are translated into U.S.
dollars for financial reporting purposes. We translate assets and liabilities of non-U.S. subsidiaries whose functional currencies are other than the U.S.
dollar at period end exchange rates, but translate revenue and expense transactions at average exchange rates for the period. We recognize cumulative
translation adjustments as part of comprehensive income, as detailed in the consolidated statements of comprehensive income, and include those
adjustments in accumulated other comprehensive income in the consolidated balance sheets until such time the relevant subsidiary is sold or
substantially or completely liquidated. We reflect gains and losses on transactions denominated in other than the functional currency of an entity in our
results of operations.
(i)
Research and Development
We record all research and development expenses in the period we incur them.
(j)
Financial Instruments
The carrying value of financial instruments, such as cash equivalents, accounts receivable and accounts payable, approximate their fair value because
of their short-term nature. The carrying value of long-term debt approximates its fair value as the principal amounts outstanding are subject to variable
interest rates that are based on market rates which are regularly reset. Foreign currency hedging instruments are marked to market and therefore reflect
their fair value. We do not hold or issue financial instruments for trading purposes.
The fair value of financial instruments is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date.
(k)
Foreign Exchange Risk Management
We enter into various types of foreign exchange contracts in managing our foreign exchange risk, including derivative financial instruments
encompassing forward exchange contracts and foreign currency options.
The purpose of our foreign currency hedging activities is to protect us from adverse exchange rate fluctuations with respect to net cash movements
resulting from the sales of products to foreign customers and Australian and Singapore manufacturing activities. We enter into foreign exchange
contracts to hedge anticipated sales and manufacturing costs, principally denominated in Australian and Singapore dollars, and Euros. The terms of
such foreign exchange contracts generally do not exceed three years.
- F9 -
Table of Contents
(2)
Summary of Significant Accounting Policies, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
We have determined our hedge program to be a non-effective hedge as defined. We record the foreign currency derivatives portfolio at fair value and
include it in other assets and accrued expenses in our consolidated balance sheets. We do not offset the fair value amounts recognized for foreign
currency derivatives. We classify purchases of foreign currency derivatives and proceeds received from the exercise of foreign currency derivatives as
an investing activity within our consolidated statements of cash flows.
We record all movements in the fair value of the foreign currency derivatives within other income, net in our consolidated statements of income.
(l)
Income Taxes
We account for income taxes under the asset and liability method. We recognize deferred tax assets and liabilities for the future tax consequences
attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. We
measure deferred tax assets and liabilities using the enacted tax rates we expect to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in
the period that includes the enactment date.
(m) Allowance for Doubtful Accounts
We maintain an allowance for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments, which
results in bad debt expense. We determine the adequacy of this allowance by periodically evaluating individual customer receivables, considering a
customer’s financial condition, credit history and current economic conditions. We are also contingently liable, within certain limits, in the event of a
customer default, to independent leasing companies in connection with customer leasing programs. We monitor the collection status of these
installment receivables and provide for estimated losses separately under accrued expenses within our consolidated balance sheets based upon our
historical collection experience with such receivables and a current assessment of our credit exposure.
(n)
Impairment of Long-Lived Assets
We periodically evaluate the carrying value of long-lived assets to be held and used, including certain identifiable intangible assets, when events and
circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of assets to be held and used is measured by a
comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If assets are considered to be impaired,
we recognize as the impairment the amount by which the carrying amount of the assets exceeds the fair value of the assets. We report assets to be
disposed of at the lower of the carrying amount or fair value less costs to sell.
We recognized no impairment charges in relation to long-lived assets during fiscal years ended June 30, 2015, 2014 and 2013.
(o)
Contingencies
We record a liability in the consolidated financial statements for loss contingencies when a loss is known or considered probable and the amount can
be reasonably estimated. If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better estimate than any
- F10 -
Table of Contents
(2)
Summary of Significant Accounting Policies, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
other, the minimum amount of the range is accrued. If a loss is reasonably possible but not known or probable, and can be reasonably estimated, the
estimated loss or range of loss is disclosed. When determining the estimated loss or range of loss, significant judgment is required to estimate the
amount and timing of a loss to be recorded.
(3)
New Accounting Pronouncements
In May, 2014, the FASB issued Accounting Standards Update (ASU), ASU No. 2014-09, “Revenue from Contracts with Customers”, which requires an
entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace
most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The new standard is effective for the Company beginning in the first
quarter of fiscal year 2019. Early application is not permitted. We are currently assessing the impact on our financial condition, results of operations and cash
flows as a result of the adoption of ASU 2014-09.
In April, 2015, the FASB issued ASU No. 2015-03, “Simplifying the Presentation of Debt Issuance Costs”. ASU 2015-03 will more closely align the
presentation of debt issuance costs under U.S. GAAP with the presentation under comparable IFRS standards by requiring that debt issuance costs be
presented on the balance sheet as a direct deduction from the carrying amount of the related debt liability. This accounting guidance is effective for us
beginning in the first quarter of fiscal 2017. We do not expect this updated standard to have a material impact on our consolidated financial statements and
related disclosures.
In July 2015, the FASB issued ASU No. 2015-11, “Simplifying the Measurement of Inventory” which requires an entity to measure inventory within the
scope of this ASU at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less
reasonably predictable costs of completion, disposal, and transportation. The amendments in this guidance more closely align the measurement of inventory
in GAAP with the measurement of inventory in International Financial Reporting Standards (IFRS). This accounting guidance is effective for us beginning
in the first quarter of fiscal 2018. We do not expect this updated standard to have a material impact on our consolidated financial statements and related
disclosures.
(4)
Earnings Per Share
We compute basic earnings per share by dividing the net income available to common stockholders by the weighted average number of shares of common
stock outstanding. For purposes of calculating diluted earnings per share, the denominator includes both the weighted average number of shares of common
stock outstanding and the number of dilutive common stock equivalents such as stock options and restricted stock units.
The weighted average number of outstanding stock options and restricted stock units not included in the computation of diluted earnings per share were
62,000, 273,000 and 236,000 for the years ended June 30, 2015, 2014 and 2013, respectively, as the effect would have been anti-dilutive.
- F11 -
Table of Contents
(4)
Earnings Per Share, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
Basic and diluted earnings per share for the years ended June 30, 2015, 2014 and 2013 are calculated as follows (in thousands except per share data):
Numerator:
Net Income, used in calculating diluted earnings per share
Denominator:
Basic weighted-average common shares outstanding
Effect of dilutive securities:
Stock options and restricted stock units
Diluted weighted average shares
Basic earnings per share
Diluted earnings per share
(5)
Inventories
Inventories were comprised of the following as of June 30, 2015 and June 30, 2014 (in thousands):
Raw materials
Work in progress
Finished goods
Total inventories
(6)
Property, Plant and Equipment, net
Property, plant and equipment, net is comprised of the following as of June 30, 2015 and June 30, 2014 (in thousands):
Machinery and equipment
Computer equipment
Furniture and fixtures
Vehicles
Clinical, demonstration and rental equipment
Leasehold improvements
Land
Buildings
Accumulated depreciation and amortization
Property, plant and equipment, net
- F12 -
2015
2014
2013
$ 352,886
$ 345,273 $ 307,133
140,468
141,474
142,954
2,219
142,687
2.51
$
2.47
$
2,885
144,359
$
$
2.44 $
2.39 $
3,456
146,410
2.15
2.10
2015
$ 74,416
2,550
169,893
$ 246,859
$
2014
53,680
3,358
108,380
$ 165,418
2015
$ 198,047
125,423
38,511
5,371
80,911
31,553
54,915
235,515
770,246
(382,488)
$ 387,758
2014
$ 200,929
133,157
42,631
4,757
101,453
30,361
62,468
266,771
842,527
(408,250)
$ 434,277
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
(7)
Goodwill and Other Intangible Assets, net
Goodwill
Changes in the carrying amount of goodwill for the years ended June 30, 2015 and June 30, 2014 (in thousands):
Balance at the beginning of the period
Business acquisition (note 22)
Foreign currency translation adjustments
Balance at the end of the period
As at June 30, 2015 we have not recorded any goodwill impairments.
Other Intangible Assets
Other intangibles, net are comprised of the following as of June 30, 2015 and June 30, 2014:
Developed/core product technology
Accumulated amortization
Developed/core product technology, net
Trade names
Accumulated amortization
Trade names, net
Non-compete agreements
Accumulated amortization
Non-compete agreements, net
Customer relationships
Accumulated amortization
Customer relationships, net
Patents
Accumulated amortization
Patents, net
Total other intangibles, net
2015
$ 289,312
20,947
(45,998)
$ 264,261
2014
$ 274,829
3,227
11,256
$ 289,312
2015
$ 67,548
(50,373)
17,175
2,500
(2,206)
294
1,747
(1,704)
43
30,538
(19,308)
11,230
66,585
(48,185)
18,400
$ 47,142
2014
$ 76,015
(54,073)
21,942
2,784
(2,697)
87
2,135
(1,768)
367
24,593
(20,877)
3,716
70,734
(51,648)
19,086
$ 45,198
Intangible assets consist of developed/core product technology, trade names, non-compete agreements, customer relationships and patents, and we amortize
them over the estimated useful life of the assets, generally between two and nine years. There are no expected residual values related to these intangible
assets.
- F13 -
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
(7)
Goodwill and Other Intangible Assets, net, Continued
Refer to note 22 of the consolidated financial statements for details of acquisitions made during the year.
Amortization expense related to identifiable intangible assets, including patents, for the year ended June 30, 2015 was $15.0 million. Estimated annual
amortization expense for the years ending June 30, 2016 through June 30, 2020, is shown below (in thousands):
Fiscal Year
2016
2017
2018
2019
2020
(8)
Cost-Method Investments
Amortization expense
15,628
$
12,193
9,070
7,309
2,404
The aggregate carrying amount of our cost-method investments at June 30, 2015 and June 30, 2014, included within our other long-term assets on our
consolidated balance sheets, was $25.6 million and $14.9 million, respectively.
We periodically evaluate the carrying value of our cost-method investments, when events and circumstances indicate that the carrying amount of an asset
may not be recovered. We determine the fair value of our cost-method investments to evaluate whether impairment losses shall be recorded using Level 3
inputs. These investments include our holdings in privately held service and research companies that are not exchange traded and therefore not supported
with observable market prices. However, these investments are valued by reference to their net asset values which can be market supported and unobservable
inputs including future cash flows. We have determined, that the fair value of our cost-method investments exceed their carrying values.
The following table shows a reconciliation of the changes in our cost-method investments during the years ended June 30, 2015 and June 30, 2014 (in
thousands):
Balance at the beginning of the period
Investments
Impairment of cost-method investments
Balance at the end of the period
- F14 -
2015
2014
$ 14,850 $ 4,000
10,850
10,750
-
-
$ 25,600 $ 14,850
Table of Contents
(9)
Accrued Expenses
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
Accrued expenses at June 30, 2015 and June 30, 2014 consist of the following (in thousands):
Product warranties
Consulting and professional fees
Value added taxes and other taxes due
Employee related costs
Marketing and promotional programs
Business acquisition contingent consideration
Hedging instruments
SERVE-HF field safety notification expenses (note 19)
Liability on receivables sold with recourse
Other
2015
$
9,823
4,412
13,863
80,086
1,581
1,584
1,954
4,320
4,155
11,198
$ 132,976
$
2014
11,798
5,891
18,310
78,948
1,192
480
3,215
-
-
10,822
$ 130,656
(10) Product Warranties
We include the liability for warranty costs in accrued expenses in our consolidated balance sheets. Changes in the liability for product warranty for the years
ended June 30, 2015 and 2014 are as follows (in thousands):
Balance at the beginning of the period
Warranty accruals for the period
Warranty costs incurred for the period
Foreign currency translation adjustments
Balance at the end of the period
(11) Long-term Debt
Long-term debt at June 30, 2015 and June 30, 2014 consists of the following (in thousands):
Current long-term debt
Non-current long-term debt
Total long-term debt
Credit Facility
2015
2014
$ 11,798
7,818
(7,649)
(2,144)
$ 9,823
$ 16,011
3,197
(7,782)
372
$ 11,798
June 30,
2015
June 30,
2014
- $
$
18
300,770
300,594
$ 300,594 $ 300,788
On October 31, 2013, we entered into a credit agreement, as borrower, with lenders, including Union Bank, N.A., as administrative agent, joint lead arranger,
swing line lender and letters of credit issuer, and HSBC Bank USA, National Association, as syndication agent and joint lead arranger. Our obligations under
the credit agreement are guaranteed by ResMed Corp. and ResMed Motor Technologies Inc., two of our U.S. subsidiaries.
- F15 -
Table of Contents
(11) Long-term Debt, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
The credit agreement provides a $700 million senior unsecured five-year revolving credit facility, with an uncommitted option to increase the credit facility
by an additional $300 million. The credit facility also includes a $25 million sublimit for letters of credit. The credit facility terminates on October 31, 2018,
when all unpaid principal and interest under the loans must be repaid. The outstanding principal amount due under the credit facility will bear interest at a
rate equal to LIBOR plus 1.0% to 2.0% (depending on the then-applicable leverage ratio). At June 30, 2015, the interest rate that was being charged on the
outstanding principal amount was 1.2%. An applicable commitment fee of 0.15% to 0.25% (depending on the then-applicable leverage ratio) applies on the
unused portion of the credit facility.
When we entered into the credit agreement, we used a portion of the proceeds from the initial funding of the credit facility to repay the outstanding balance
under our previous revolving credit facility with Union Bank, N.A and other lenders. On that repayment, the previous credit agreement, dated as of
February 10, 2011, between us and lenders (including Union Bank, N.A., as administrative agent, swing line lender and L/C Issuer, HSBC Bank USA,
National Association, as syndication agent and Union Bank, N.A., HSBC Bank USA, National Association, Commonwealth Bank of Australia and Wells
Fargo Bank), was terminated and the commitments under the previous credit agreement were also terminated.
Our obligations under the current credit agreement are unsecured but are guaranteed by two of our U.S. subsidiaries. The credit agreement contains
customary covenants, including certain financial covenants and an obligation that we maintain certain financial ratios, including a maximum leverage ratio of
funded debt to EBITDA (as defined in the credit agreement) and an interest coverage ratio. The entire principal amount of the credit facility and any accrued
but unpaid interest may be declared immediately due and payable if an event of default occurs, as defined in the credit agreement. Events of default under the
credit agreement include failure to make payments when due, the occurrence of a default in the performance of any covenants in the credit agreement or
related documents, or certain changes of control of ResMed Inc., ResMed Corp., ResMed Motor Technologies Inc., ResMed Limited, ResMed Holdings
Ltd/LLC or ResMed EAP Holdings LLC.
At June 30, 2015, there was $300.0 million outstanding under the credit agreement.
(12) Stockholders’ Equity
Common Stock. On February 21, 2014, our board of directors approved a new share repurchase program, authorizing us to acquire up to an aggregate of
20.0 million shares of our common stock. The program allows us to repurchase shares of our common stock from time to time for cash in the open market, or
in negotiated or block transactions, as market and business conditions warrant and subject to applicable legal requirements. This program canceled and
replaced our previous share repurchase program authorized on August 24, 2011, under which we had repurchased 18.1 million shares. The 20.0 million
shares the new program authorizes us to purchase are in addition to the shares we repurchased on or before February 21, 2014 under our previous programs.
There is no expiration date for this program, and the program may be accelerated, suspended, delayed or discontinued at any time at the discretion of our
board of directors. All share repurchases since February 21, 2014 have been executed in accordance with this program.
During the fiscal years 2015 and 2014, we repurchased 2.7 million and 4.4 million shares, respectively, at a cost of $152.6 million and $208.1 million,
respectively. At June 30, 2015, we have repurchased a total of 39.2 million shares at a cost of $1.4 billion. Shares that are repurchased are classified as
“treasury stock pending future use” and reduce the number of shares outstanding used in calculating earnings per share. At June 30, 2015, 15.5 million
additional shares can be repurchased under the approved share repurchase program.
Preferred Stock. In April 1997, our board of directors authorized 2,000,000 shares of $0.01 par value preferred stock. No such shares were issued or
outstanding at June 30, 2015.
- F16 -
Table of Contents
(12) Stockholders’ Equity, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
Stock Options and Restricted Stock Units. We have granted stock options and restricted stock units to personnel, including officers and directors, in
accordance with the ResMed Inc. 2009 Incentive Award Plan (the “2009 Plan”). These options and restricted stock units vest over one to four years and the
options have expiration dates of seven years from the date of grant. We have granted the options with an exercise price equal to the market value as
determined at the date of grant.
The maximum number of shares of our common stock authorized for issuance under the 2009 Plan is 43.7 million. The number of securities remaining
available for future issuance under the 2009 Plan at June 30, 2015 is 13.6 million. The number of shares of our common stock available for issuance under
the 2009 Plan will be reduced by (i) 2.8 shares for each one share of common stock delivered in settlement of any “full-value award,” which is any award
other than a stock option, stock appreciation right or other award for which the holder pays the intrinsic value and (ii) one share for each share of common
stock delivered in settlement of all other awards. The maximum number of shares, which may be subject to awards granted under the 2009 Plan to any
individual during any calendar year, may not exceed 3 million shares of our common stock (except in a participant’s initial year of hiring up to 4.5 million
shares of our common stock may be granted).
At June 30, 2015, there was $68.8 million in unrecognized compensation costs related to unvested stock-based compensation arrangements. This is expected
to be recognized over a weighted average period of 2.2 years. The aggregate intrinsic value of the stock-based compensation arrangements outstanding and
exercisable at June 30, 2015 was $205.5 million and $66.4 million, respectively. The aggregate intrinsic value of the options exercised during the fiscal years
2015, 2014, and 2013 was $80.2 million, $50.2 million and $77.8 million, respectively.
The following table summarizes option activity during the year ended June 30, 2015:
Outstanding at beginning of period
Granted
Exercised*
Forfeited
Outstanding at end of period
Exercise price granted options
Options exercisable at end of period
* Includes 45,000 shares netted for tax.
4,687,220
97,209
(1,999,003)
23,812
2,809,238
52.02
$
2,233,134
Weighted
Average
Exercise
Price
$ 24.45
52.02
18.60
33.96
$ 29.63
$ 26.62
Weighted Average
Remaining Term
to Vest in Years
2.6
2.5
- F17 -
Table of Contents
(12) Stockholders’ Equity, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
The following table summarizes the activity of restricted stock units, including performance restricted stock units, during year ended June 30, 2015:
Outstanding at beginning of period
Granted
Vested*
Forfeited
Outstanding at end of period
* Includes 222,486 shares netted for tax.
Weighted
Average
Grant-
Date Fair
Value
$ 38.58
50.23
36.06
39.19
$ 43.65
Weighted Average
Remaining Term
to Vest in Years
1.3
1.2
2,448,331
821,714
(873,578)
(83,938)
2,312,529
Employee Stock Purchase Plan (the “ESPP”). Under the ESPP, we offer participants the right to purchase shares of our common stock at a discount
during successive offering periods. Each offering period under the ESPP will be for a period of time determined by the board of directors’ compensation
committee of no less than 3 months and no more than 27 months. The purchase price for our common stock under the ESPP will be the lower of 85% of the
fair market value of our common stock on the date of grant or 85% of the fair market value of our common stock on the date of purchase. An individual
participant cannot subscribe for more than $25,000 in common stock during any calendar year. At June 30, 2015, the number of shares remaining available
for future issuance under the ESPP is 1.5 million shares.
During fiscal years 2015 and 2014, we issued 309,000 and 314,000 shares to our employees in two offerings and we recognized $3.3 million and $3.1
million, respectively, of stock compensation expense associated with the ESPP.
The following table summarizes the total stock-based compensation costs incurred and the associated tax benefit recognized during the years ended June 30,
2015, 2014 and 2013 (in thousands):
Cost of sales – capitalized as part of inventory
Selling, general and administrative expenses
Research and development expenses
Stock-based compensation costs
Tax benefit
Stock-based compensation costs, net of tax benefit
- F18 -
2015
$ 2,605
38,755
6,495
47,855
(14,100)
$ 33,755
2014
$ 2,621
34,667
6,169
43,457
(11,744)
$ 31,713
2013
$ 2,484
30,552
5,121
38,157
(11,960)
$ 26,197
Table of Contents
(13) Other, net
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
Other, net, in the consolidated statements of income is comprised of the following for the years ended June 30, 2015, 2014 and 2013 (in thousands):
Gain (loss) on foreign currency transactions and hedging, net
Impairment of cost method investments
Other
2015
$5,068
-
1,182
$6,250
2013
2014
$590 $(1,902)
(475)
-
294
186
$884 $(2,191)
(14) Income Taxes
Income before income taxes for the years ended June 30, 2015, 2014 and 2013, was taxed under the following jurisdictions (in thousands):
U.S.
Non-U.S.
The provision for income taxes is presented below (in thousands):
Current: Federal
State
Non-U.S.
Deferred: Federal
State
Non-U.S.
Provision for income taxes
- F19 -
2015
$ 11,431
424,485
$ 435,916
2014
2013
2,556 $
$
2,120
382,999
428,522
$ 431,078 $ 385,119
2015
$28,429
695
50,892
80,016
(4,269)
(180)
7,463
3,014
$83,030
2014
$18,931
1,334
55,675
75,940
(420)
(81)
10,366
9,865
$85,805
2013
$ 42,065
888
53,713
96,666
(1,345)
(264)
(17,071)
(18,680)
$ 77,986
Table of Contents
(14) Income Taxes, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
The provision for income taxes differs from the amount of income tax determined by applying the applicable U.S. federal income tax rate of 35% to pretax
income as a result of the following (in thousands):
Taxes computed at statutory U.S. rate
Increase (decrease) in income taxes resulting from:
State income taxes, net of U.S. tax benefit
Research and development credit
Tax effect of dividends
Change in valuation allowance
Effect of non-U.S. tax rates
Foreign tax credits
Stock-based compensation expense
Other
2015
$ 152,570
2014
$ 150,877
2013
$ 134,792
348
(4,821)
56,219
(614)
(87,721)
(36,725)
3,158
616
$ 83,030
794
(5,395)
87,764
5,894
(83,135)
(73,975)
3,431
(450)
$ 85,805
257
(4,920)
72,304
1,852
(97,420)
(34,729)
3,167
2,683
$ 77,986
We classify deferred tax assets and liabilities as current or non-current according to the related asset or liability’s classification. The components of our
deferred tax assets and liabilities at June 30, 2015 and 2014 are as follows (in thousands):
Deferred tax assets:
Employee liabilities
Inventories
Provision for warranties
Provision for doubtful debts
Net operating loss carryforwards
Capital loss carryover
Stock-based compensation expense
Unrealized foreign exchange losses
Other
Less valuation allowance
Deferred tax assets
Deferred tax liabilities:
Unrealized foreign exchange gains
Property, plant and equipment
Goodwill and other intangibles
Deferred tax liabilities
Net deferred tax asset
- F20 -
2015
2014
$ 11,663
8,822
2,722
3,779
13,262
1,805
18,173
-
5,446
65,672
(14,647)
51,025
(512)
(2,291)
(8,214)
(11,017)
$ 40,008
$ 11,606
10,457
2,752
2,985
14,554
1,908
17,268
688
4,253
66,471
(15,573)
50,898
-
(1,892)
(9,776)
(11,668)
$ 39,230
Table of Contents
(14) Income Taxes, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
We reported the net deferred tax assets and liabilities in our consolidated balance sheets at June 30, 2015 and 2014 as follows (in thousands):
Current deferred tax asset
Non-current deferred tax asset
Current deferred tax liability
Non-current deferred tax liability
Net deferred tax asset
2015
$36,338
12,528
(796)
(8,062)
$40,008
2014
$ 31,908
18,755
(717)
(10,716)
$ 39,230
At June 30, 2015, we had $7.5 million of U.S. state net operating loss carryforwards and $64.1 million of non-U.S. net operating loss carryforwards, which
expire in various years through 2020 or carry forward indefinitely.
The valuation allowance at June 30, 2015 relates to a provision for uncertainty as to the utilization of net operating loss carryforwards for certain non-U.S.
countries of $12.6 million and U.S. and non-U.S. capital loss and other items of $2.0 million. We believe that it is more likely than not that the benefits of
deferred tax assets, net of any valuation allowance, will be realized.
A substantial portion of the Company’s manufacturing operations and administrative functions in Malaysia and Singapore operate under various tax holidays
and tax incentive programs that will expire in whole or in part at various dates through June 30, 2020. Certain of the holidays may be extended if specific
conditions are met. The net impact of these tax holidays and tax incentive programs was to increase the Company’s net earnings by $18.9 million ($0.13 per
diluted share) for the year ended June 30, 2015 and $23.6 million ($0.16 per diluted share) for the year ended June 30, 2014.
At June 30, 2015, applicable U.S. federal income taxes and foreign withholding taxes have not been provided on the accumulated earnings of foreign
subsidiaries that are expected to be permanently reinvested. The total amount of these undistributed earnings at June 30, 2015 amounted to approximately
$1.4 billion. If these earnings had not been permanently reinvested, deferred taxes of approximately $364 million would have been recognized in the
consolidated financial statements.
In accounting for uncertainty in income taxes, we recognize a tax benefit in the financial statements for an uncertain tax position only if management’s
assessment is that the position is “more likely than not” (that is, a likelihood greater than 50 percent) to be allowed by the tax jurisdiction based solely on the
technical merits of the position. The term “tax position” refers to a position in a previously filed tax return or a position expected to be taken in a future tax
return that is reflected in measuring current or deferred income tax assets and liabilities for annual periods.
The Company recognizes interest and penalties related to unrecognized tax benefits within the income tax expense line in the accompanying consolidated
statements of income. Accrued interest and penalties are included within the related tax liability line in the consolidated balance sheets.
Based on all known facts and circumstances and current tax law, we believe the total amount of unrecognized tax benefits on June 30, 2015, is not material
to our results of operations, financial condition or cash flows, and if recognized, would not have a material impact on our effective tax rate.
(15) Segment Information
We operate solely in the sleep and respiratory disorders sector of the medical device industry. We therefore believe that, given the single-industry focus of
our operations and the inter-dependence of our products, we operate as a single operating segment.
- F21 -
Table of Contents
(15) Segment Information, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
Sales of flow generators for each of the years ended June 30, 2015, 2014 and 2013 were $975.9 million, $846.7 million and $823.5 million, respectively.
Sales of masks other accessories for each of the years ended June 30, 2015, 2014 and 2013 were $703.0 million, $708.3 million and $690.9 million,
respectively. Financial information by geographic area for the years ended June 30, 2015, 2014 and 2013, is summarized below (in thousands):
North and Latin America
Germany
France
Australia
Rest of the World
Total
Revenue from external sources
for the years ended June 30,
2014
839,126 $
214,598
152,271
33,379
315,599
1,554,973 $
2015
962,696 $
184,245
145,504
42,174
344,293
1,678,912 $
$
$
2013
851,608 $
195,091
138,891
35,503
293,364
1,514,457 $
Long lived assets
at June 30,
2014
133,986
23,382
8,955
245,718
22,236
434,277
2015
140,344 $
18,706
5,610
197,609
25,489
387,758 $
$
$
2013
136,984
24,855
6,282
222,814
20,498
411,433
Long-lived assets of geographic areas are those assets used in our operations in each geographical area, and excludes goodwill, other intangible assets, and
deferred tax assets.
(16) Stock-based Employee Compensation
We measure the compensation expense of all stock-based awards at fair value on the grant date. We estimate the fair value of stock options and purchase
rights granted under the ESPP using the Black-Scholes valuation model. The fair value of restricted stock units is equal to the market value of the underlying
shares as determined at the grant date less the fair value of dividends that holders are not entitled to, during the vesting period. We recognize the fair value as
compensation expense using the straight-line method over the service period for awards expected to vest.
We estimate the fair value of stock options granted under our stock option plans and purchase rights granted under the ESPP using the following
assumptions:
Stock options:
Weighted average grant date fair value
Weighted average risk-free interest rate
Expected option life in years
Dividend yield
Expected volatility
ESPP purchase rights:
Weighted average risk-free interest rate
Expected option life in years
Dividend yield
Expected volatility
Fiscal Year Ended June 30,
2015
2014
$10.58
1.60%
4.9
$10.90
1.44%
4.9
2.15% - 2.15%
27%
1.95% - 2.17%
30%
0.1%
6 months
1.73% - 2.17%
22% - 26%
0.1%
6 months
1.44% - 2.00%
24% - 28%
During the fiscal years ended June 30, 2015 and 2014, we granted 216,000 and 187,000, performance restricted stock units (“PRSUs”), which contain a
market condition, with the ultimate realizable number of PRSUs dependent on relative total stockholder return over a three-year period, up to a maximum
amount to
- F22 -
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
(16) Stock-based Employee Compensation, Continued
be issued under the award of 200% of the original grant. The weighted average grant date fair value of PRSUs granted during the fiscal years 2015 and 2014
was estimated at $51.12 and $50.08 per PRSU, respectively, using a Monte-Carlo simulation valuation model.
(17) Employee Retirement Plans
We contribute to a number of employee retirement plans for the benefit of our employees. Details of the main plans are as follows:
(1) Australia - We contribute to defined contribution plans for each employee resident in Australia. All Australian employees, after serving a qualifying
period, are entitled to benefits on retirement, disability or death. Employees may contribute additional funds to the plans. We contribute to the plans at the
rate of approximately 9.5% of the salaries of all Australian employees. Our total contributions to the plans for the years ended June 30, 2015, 2014 and 2013,
were $9.9 million, $9.9 million and $10.3 million, respectively.
(2) United Kingdom - We contribute to a defined contribution plan for each permanent United Kingdom employee. All employees, after serving a three-
month qualifying period, are entitled to benefit on retirement, disability or death. Employees may contribute additional funds to the plan. We contribute to
the plan at the rate of 5% of the salaries of all United Kingdom employees. Our total contributions to the plan were $0.5 million, $0.5 million and $0.3
million in fiscal 2015, 2014, and 2013, respectively.
(3) United States - We sponsor a defined contribution plan available to substantially all domestic employees. Company contributions to this plan are based
on a percentage of employee contributions to a maximum of 4% of the employee’s salary. Our total contributions to the plan were $3.2 million, $2.9 million
and $2.9 million in fiscal 2015, 2014, and 2013, respectively.
(4) Switzerland - We sponsor a fixed return defined contribution fund for each permanent Swiss employee. As part of our contribution to the fund, we
guarantee a fixed 2% net return on accumulated contributions per annum. We contribute to the plan at variable rates that have averaged 8% of salaries over
the last three years. Our total contributions to the plan were $0.4 million, $0.4 million and $0.4 million in fiscal 2015, 2014, and 2013, respectively.
(18) Commitments
We lease buildings, motor vehicles and office equipment under operating leases. We expense rental charges for operating leases on a straight-line basis over
the lease term taking into account rent concessions or holidays. Rent expenses under operating leases for the years ended June 30, 2015, 2014 and 2013 were
approximately $17.0 million, $16.5 million and $15.2 million, respectively. At June 30, 2015 we had the following future minimum lease payments under
non-cancelable operating leases (in thousands):
Fiscal Years
2016
2017
2018
2019
2020
Thereafter
Total minimum lease payments
- F23 -
Operating Leases
16,915
$
12,910
8,453
5,349
3,817
12,293
59,737
$
Table of Contents
(19) Legal Actions and Contingencies
Litigation
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
In the normal course of business, we are subject to routine litigation incidental to our business. While the results of this litigation cannot be predicted with
certainty, we believe that their final outcome will not, individually or in aggregate, have a material adverse effect on our consolidated financial statements
taken as a whole.
Contingent Obligations Under Recourse Provisions
We use independent leasing companies to provide financing to certain customers for the purchase of our products. In some cases, we are contingently liable
in the event of a customer default, to the leasing companies, within certain limits, for unpaid installment receivables transferred to the leasing companies.
The gross amount of receivables sold, with recourse, during the fiscal years 2015 and 2014, amounted to $31.5 million and $6.6 million, respectively. The
maximum potential amount of contingent liability under these arrangements at June 30, 2015 and June 30, 2014 were $7.2 million, and $4.9 million,
respectively. The recourse liability recognized by us at June 30, 2015 and June 30, 2014, in relation to these arrangements was $0.5 million and $0.5 million,
respectively.
SERVE-HF Field Safety Notification
On May 13, 2015 we announced the preliminary analysis of the data on SERVE-HF clinical trial designed to assess whether the treatment of moderate to
severe predominant central sleep apnea with Adaptive Servo-Ventilation (ASV) therapy could reduce mortality and morbidity in patients with symptomatic
chronic heart failure. The preliminary headline results showed no significant difference with respect to all-cause mortality and hospitalization. However, the
analysis of the data identified a statistically significant, 2.5 percent absolute, increased risk of cardiovascular mortality for those patients in the trial who
received ASV therapy with moderate to severe predominant central sleep apnea and symptomatic chronic heart failure with reduced ejection fraction. We are
working with global regulatory authorities to revise the labels and instructions for use for ResMed ASV devices as well as informing healthcare providers,
physicians, and patients of the cardiovascular safety signal observed in SERVE-HF. During the year ended June 30, 2015 we recognized $5.0 million in
expenses associated with SERVE-HF field safety notification activities within cost of sales. At June 30, 2015, we had incurred $0.7 million of actual
expenses, with the remaining balance of $4.3 million recognized as an accrual.
(20) Fair Value Measurements
In determining the fair value measurements of our financial assets and liabilities, we consider the principal and most advantageous market in which we
transact and consider assumptions that market participants would use when pricing the financial asset or liability. We maximize the use of observable inputs
and minimize the use of unobservable inputs when measuring fair value.
The hierarchies of inputs are as follows:
• Level 1:
Input prices quoted in an active market for identical financial assets or liabilities;
• Level 2:
Inputs other than prices quoted in Level 1, such as prices quoted for similar financial assets and liabilities in active markets, prices
for identical assets and liabilities in markets that are not active or other inputs that are observable or can be corroborated by
observable market data; and
• Level 3:
Input prices quoted that are significant to the fair value of the financial assets or liabilities which are not observable nor supported
by an active market.
- F24 -
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
(20) Fair Value Measurements, Continued
The following table summarizes our financial assets and liabilities, as at June 30, 2015 and June 30, 2014, using the valuation input hierarchy (in thousands):
Balances at June 30, 2015
Foreign currency hedging instruments, net
Business acquisition contingent consideration
Balances at June 30, 2014
Foreign currency hedging instruments, net
Business acquisition contingent consideration
Level 1
Level 2
Level 3
Total
$
$
$
$
-
-
-
-
$ 1,038
-
$
$ (2,270)
-
$
-
$
$ (1,584)
$
-
$ (480)
$ 1,038
$ (1,584)
$ (2,270)
(480)
$
We determine the fair value of our financial assets and liabilities as follows:
Foreign currency options – These financial instruments are valued using third-party valuation models based on market observable inputs, including interest
rate curves, on-market spot currency prices, volatilities and credit risk.
Contingent consideration – These liabilities include the fair value estimates of additional future payments that may be required for some of our previous
business acquisitions based on the achievement of certain performance milestones. Each potential future payment is valued using the estimated probability of
achieving each milestone, which is then discounted to present value.
The following is a reconciliation of changes in the fair value of contingent consideration during fiscal years ended June 30, 2015 and June 30, 2014 (in
thousands):
Balance at the beginning of the period
Acquisition date fair value of contingent consideration
Changes in fair value included in operating income
Payments
Foreign currency translation adjustments
Balance at the end of the period
$
2015
(480)
(1,717)
132
458
23
$ (1,584)
2014
$ (7,779)
-
6,283
1,117
(101)
(480)
$
We did not have any significant non-financial assets or liabilities measured at fair value on June 30, 2015 or June 30, 2014.
(21) Derivative Instruments and Hedging Activities
We transact business in various foreign currencies, including a number of major European currencies as well as the Australian and Singapore dollars. We
have significant foreign currency exposure through both our Australian and Singaporean manufacturing activities, and international sales operations. We
have established a foreign currency hedging program using purchased currency options and forward contracts to hedge foreign-currency-denominated
financial assets, liabilities and manufacturing cash flows. The terms of such foreign currency hedging contracts generally do not exceed three years. The goal
of this hedging program is to economically manage the financial impact of foreign currency exposures denominated mainly in Euros, Australian and
Singapore dollars. Under this program, increases or decreases in our foreign currency denominated financial assets, liabilities, and firm commitments are
partially offset by gains and losses on the hedging instruments.
We do not designate these foreign currency contracts as hedges. We have determined our hedge program to be a non-effective hedge as defined under the
FASB issued authoritative guidance. All movements in the
- F25 -
Table of Contents
(21) Derivative Instruments and Hedging Activities, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
fair value of the foreign currency instruments are recorded within other income, net in our consolidated statements of income. We do not enter into financial
instruments for trading or speculative purposes.
We held foreign currency instruments with notional amounts totaling $576.5 million and $473.7 million at June 30, 2015 and June 30, 2014, respectively, to
hedge foreign currency fluctuations. These contracts mature at various dates prior to June 30, 2018.
The following table summarizes the amount and location of our derivative financial instruments as of June 30, 2015 and June 30, 2014 (in thousands):
Foreign currency hedging instruments
Foreign currency hedging instruments
Foreign currency hedging instruments
June 30, 2015
1,644
$
1,348
(1,954)
$
1,038
June 30, 2014
456
$
489
(3,215)
$
(2,270)
Balance Sheet Caption
Other assets - current
Other assets - non current
Accrued expenses
The following table summarizes the amount and location of gains (losses) associated with our derivative financial instruments and other foreign-currency-
denominated transactions for the fiscal year ended June 30, 2015 and June 30, 2014, respectively (in thousands):
Foreign currency hedging instruments
Other foreign-currency-denominated transactions
Gain /(Loss) Recognized
Year Ended June 30,
Income Statement Caption
2015
$ (29,419)
34,487
$ 5,068
2014
$ 5,652
(5,062)
590
$
Other, net
Other, net
Other, net
We are exposed to credit-related losses in the event of non-performance by counter parties to financial instruments. We minimize counterparty credit risk by
entering into derivative transactions with major financial institutions and we do not expect material losses as a result of default by our counterparties.
(22) Business Combinations
During the year ended June 30, 2015 we acquired four distributors of equipment and services for the treatment of sleep-disordered breathing and respiratory
disorders, based in Australia and New Zealand, including ResSleep International Pty Ltd, which was a related party. During the year ended June 30, 2015 we
also acquired Jaysec Technologies LLC, a provider of internet-based software solutions for the home medical equipment (HME) industry, and the business
assets of CareTouch, a provider of internet-based solutions and therapy-focused resupply programs for home medical equipment providers. These
acquisitions have been accounted for as business combinations using purchase accounting and are included in our consolidated financial statements from
their respective acquisition dates. The acquisitions are not considered material business combinations and accordingly pro forma information is not provided.
The acquisitions were funded through cash on-hand and we have not incurred any material acquisition related costs.
We have completed the purchase price allocation for the above acquisitions. The cost of the acquisitions has been allocated to the assets acquired and
liabilities assumed based on estimates of their fair values at the date of acquisition. As part of the purchase price allocation, we recognized an intangible asset
relating to customer relationships of $12.0 million, with an estimated useful life of 5 years, developed technology of $4.6 million, with an estimated useful
life of 5 years, and goodwill of $20.9 million. The goodwill
- F26 -
Table of Contents
(22) Business Combinations, Continued
R ES M ED I NC . AND S UBSIDIARIES
Notes to Consolidated Financial Statements
recognized as part of these acquisitions, of which $13.0 million is not deductible for tax purposes, mainly represents the synergies that are unique to our
combined businesses and the potential for new products and services to be developed in the future.
(23) Restructuring Expenses and Education, Research and Settlement Charge
During the year ended June 30, 2014 we completed a reorganization of our commercial and research and development teams. As a result of this
reorganization we terminated the employment of approximately 1% of our employees at a total cost of $6.3 million ($4.2 million net of tax). We recorded
and paid the full amount of $6.3 million in the year ended June 30, 2014, within our operating expenses and separately disclosed the amount as restructuring
expenses.
During the year ended June 30, 2013 we agreed to pay the University of Sydney $24.8 million to establish two perpetual academic chairs, fund future
research in the fields of sleep medicine and biomedical engineering, and settle legal proceedings between us. We expensed the full amount of $24.8 million
($17.7 million, net of tax) in the year ended June 30, 2013 within our operating expenses and separately disclosed the amount as an education, research and
settlement charge.
- F27 -
Table of Contents
S CHEDULE II
R ES M ED I NC . AND S UBSIDIARIES
V ALUATION AND Q UALIFYING A CCOUNTS AND R ESERVES
Y EARS E NDED J UNE 30, 2015, 2014 AND 2013
(in thousands)
Year ended June 30, 2015
Applied against asset account
Allowance for doubtful accounts
Year ended June 30, 2014
Applied against asset account
Allowance for doubtful accounts
Year ended June 30, 2013
Applied against asset account
Allowance for doubtful accounts
Balance
at
Beginning
of Period
Charged
to costs
and
expenses
Other
(deductions)
Balance
at end
of
period
$ 10,971
3,559
(2,254)
$12,276
$ 9,912
5,306
(4,247)
$10,971
See accompanying report of independent registered public accounting firm.
$ 7,313
5,938
(3,339)
$ 9,912
Table of Contents
R ES M ED I NC . AND S UBSIDIARIES
SIGNATURES
Under the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the
authorized persons below.
DATED August 6, 2015
ResMed Inc.
/ S / M ICHAEL J. F ARRELL
Michael J. Farrell
Chief executive officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in
the capacities and on the dates indicated.
SIGNATURE
TITLE
/ S / M ICHAEL J. F ARRELL
Michael J. Farrell
/ S / B RETT A. S ANDERCOCK
Brett A. Sandercock
Chief executive officer and director (Principal Executive
Officer)
Chief financial officer
(Principal Financial Officer and
Principal Accounting Officer)
DATE
August 6, 2015
August 6, 2015
/ S / P ETER C. F ARRELL
Non-executive chairman
August 6, 2015
Peter C. Farrell
/ S / C HRISTOPHER G. R OBERTS
Director
Christopher G. Roberts
/ S / C AROL J. B URT
Director
Carol J. Burt
/ S / G ARY W. P ACE
Director
Gary W. Pace
/ S / R ICHARD S ULPIZIO
Director
Richard Sulpizio
/ S / R ON T AYLOR
Director
Ron Taylor
/ S / J OHN P. W AREHAM
Director
John P. Wareham
S-1
August 6, 2015
August 6, 2015
August 6, 2015
August 6, 2015
August 6, 2015
August 6, 2015
Table of Contents
The following documents are filed as part of this report:
R ESMED I NC . AND S UBSIDIARIES
E XHIBIT I NDEX
(a)
(b)
3.1
3.2
4.1
10.1
10.2*
10.3*
10.4*
10.5*
10.6*
10.7*
10.8*
10.9
10.10
10.11*
10.12
10.13
10.14
10.15
10.16
10.17
10.18
10.19
10.20
10.21
10.22
10.23
21.1
Consolidated Financial Statements and Schedules – The index to our consolidated financial statements and schedules are set forth in the “Index to
Consolidated Financial Statements” under Item 8 of this report.
Exhibit Lists
First Restated Certificate of Incorporation of ResMed Inc., as amended.
(16)
Fifth Amended and Restated Bylaws of ResMed Inc.
(13)
Form of certificate evidencing shares of Common Stock.
(1)
Licensing Agreement between the University of Sydney and ResMed Ltd dated May 17, 1991, as amended.
(1)
ResMed Inc. 2006 Incentive Award Plan.
(6)
Amendment No. 1 to the ResMed Inc. 2006 Incentive Award Plan.
(3)
2006 Grant agreement for Board of Directors.
(3)
2006 Grant agreement for Executive Officers.
(5)
2006 Grant agreement for Australian Executive Officers.
(5)
Form of Executive Agreement.
(4)
Amended and Restated 2006 Incentive Award Plan dated November 20, 2008.
(7)
Form of Indemnification Agreements for our directors and officers.
(8)
Form of Access Agreement for directors.
(8)
Updated Form of Executive Agreement.
(2) (12)
ResMed Inc. 2009 Incentive Award Plan.
(9)
ResMed Inc. 2009 Employee Stock Purchase Plan.
(9)
Amendment No. 1 to the ResMed Inc. 2009 Employee Stock Purchase Plan
(14)
Form of Restricted Stock Award Agreement.
(9)
ResMed Inc. Deferred Compensation Plan.
(10)
Credit Agreement, dated as of October 31, 2013, among ResMed Inc., the lenders Union Bank, N.A., as administrative agent, joint lead arranger,
swing line lender and letters of credit issuer and HSBC Bank USA, National Association, as syndication agent and joint lead arranger.
(17)
Unconditional Guaranty entered into as of October 31, 2013, by each of ResMed Corp. and ResMed Motor Technologies Inc., in favor of Union
Bank, N.A., as administrative agent.
(17)
Form of Restricted Stock Unit Award Agreement for Executive Officers.
(11)
Form of Restricted Stock Unit Award Agreement for Directors.
(11)
Form of Stock Option Grant for Executive Officers.
(11)
Form of Stock Option Grant for Directors.
(11)
Form of Performance-Based Restricted Stock Unit Award Agreement for Executive Officers.
(15)
Subsidiaries of the Registrant.
(18)
Table of Contents
23.1
31.1
31.2
32.1
101
Consent of Independent Registered Public Accounting Firm.
(18)
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
(18)
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
(18)
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
(18)
The following materials from ResMed Inc.’s Annual Report on Form 10-K for the fiscal year ended June 30, 2015 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 and Statements of Cash Flows and (v) related notes.
* Management contract or compensatory plan or arrangement
(1)
Incorporated by reference to the Registrant’s Registration Statement on Form S-1 (No. 33-91094) declared effective on June 1, 1995.
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Incorporated by reference to the Registrant’s Report on Form 10-K for the year ended June 30, 2009.
Incorporated by reference to the Registrant’s Report on Form 10-Q for the quarter ended December 31, 2006.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on July 13, 2007.
Incorporated by reference to the Registrant’s Report on Form 10-K for the year ended June 30, 2007.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on November 15, 2006.
Incorporated by reference to Appendix A of the Registrant’s Definitive Proxy Statement filed on October 15, 2008.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on June 24, 2009.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on November 23, 2009.
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
Incorporated by reference to the Registrant’s Report on Form 8-K filed on May 25, 2010.
Incorporated by reference to the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2011.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on July 2, 2012.
Incorporated by reference to the Registrant’s Report on Form 8-K/A filed on September 17, 2012.
Incorporated by reference to Appendix A of the Registrant’s Definitive Proxy Statement filed on October 4, 2012.
Incorporated by reference to the Registrant’s Report on Form 8-K filed on November 21, 2012.
Incorporated by reference to Exhibit 3.1 to the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2013
Incorporated by reference to Exhibits 10.1 and 10.2 to the Registrant’s Report on Form 8-K filed on November 5, 2013
Filed with this report.
R ES M ED I NC .
S UBSIDIARIES OF THE R EGISTRANT
E XHIBIT 21.1
(4)
(3)
(1)
(4)
(1)
(1)
(1)
(2)
(1)
(1)
(1)
(1)
(1)
(1)
(11)
(10)
(15)
ResMed Corp. (a Minnesota corporation)
ResMed (Malaysia) Sdn Bhd (a Malaysian Corporation)
ResMed (UK) Limited (a United Kingdom corporation)
ResMed (EPN) Limited (a United Kingdom corporation)
ResMed Asia Pacific Limited (incorporated in Australia)
ResMed Beteiligungs GmbH (a German corporation, formerly ResMed Deutschland GmbH)
ResMed EAP Holdings Inc. (a Delaware corporation)
ResMed Finland OY (a Finland corporation)
ResMed Holdings Limited (incorporated in Australia)
ResMed Hong Kong Limited (a Hong Kong corporation)
ResMed Germany Inc. (a Delaware corporation, formerly ResMed International Inc.)
ResMed KK (a Japanese corporation)
ResMed Limited (incorporated in Australia)
ResMed Asia Operations Pty Ltd (incorporated in Australia)
ResMed New Zealand Limited (a New Zealand Corporation)
ResMed GmbH Verwaltung (a German corporation)
ResMed GmbH and Co KG (a German corporation)
ResMed SAS (a French corporation)
ResMed Sweden AB (a Swedish corporation)
ResMed Motor Technologies Inc. (a Delaware corporation, formerly Servo Magnetics Inc.)
ResMed Schweiz AG (A Swiss corporation, formerly Labhardt AG)
ResMed Austria Medizintechnik GmbH (an Austrian corporation)
(1)
ResMed R&D Germany GmbH (a German corporation, formerly MAP Medizin-Technologie GmbH )
MAP Beteiligungs GmbH (a German corporation)
(5)
ResMed Deutschland GmbH (a German corporation, formerly Take Air Medical Handels GmbH)
ResMed Medizintechnik GmbH (a German corporation)
ResMed Brasil Ltda (a Brazilian corporation)
ResMed Columbia SAS (a Columbian corporation)
ResMed Norway AS (a Norwegian corporation, formerly PolarMed AS)
ResMed Nederland BV (a Netherlands corporation)
ResMed Paris SAS (a French corporation)
ResMed Mexico, S de R.L. de C.V. (incorporated in Mexico)
ResMed India Private Ltd (incorporated in India)
ResMed (Beijing) Medical Device Co., Ltd
ResMed Enterprise Management (Shenzhen) Co., Ltd
Healing Partner Limited (a Hong Kong corporation)
(1)
ResMed European Operations B.V (a Netherlands corporation)
ResMed Malaysia Operations Sdn Bhd (a Malaysian corporation)
ResMed Sensor Technologies Ltd (incorporated in Ireland, formerly BiancaMed Ltd )
ResMed Humidification Technologies GmbH (a German corporation, formerly Gruendler GmbH)
Healthcare Investment Holdings Ltd (incorporated in Australia)
Umbian Inc (incorporated in Canada)
ResMed Korea Ltd (incorporated in Korea)
ResMed Taiwan Co., Ltd (incorporated in Taiwan)
ResMed European Holdings Ltd (a United Kingdom corporation)
Mediserv Sp. Zoo (incorporated in Poland)
Unimedis s.r.o. (incorporated in Czech Republic)
Salve Wohngruppen GmbH (incorporated in Germany)
ResMed Sleep Solutions Limited (a United Kingdom corporation)
RMA Inc (a Delaware corporation)
Jaysec Technologies LLC (a Tennessee corporation)
CPAP Australia Pty Limited (incorporated in Australia)
Sleep and Breathing Solutions Pty Limited (incorporated in Australia)
ResSleep International Pty Limited (incorporated in Australia)
Sleeptech Limited (a New Zealand corporation)
EdenSleep New Zealand Limited (a New Zealand corporation)
(16)
(16)
(14)
(15)
(11)
(17)
(13)
(11)
(14)
(15)
(11)
(12)
(11)
(11)
(15)
(1)
(1)
(7)
(8)
(1)
(1)
(7)
(9)
(1)
(1)
(9)
(7)
(1)
(4)
(4)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
A subsidiary of ResMed Holdings Limited
A subsidiary of ResMed EAP Holdings Inc.
A subsidiary of ResMed Germany Inc.
A subsidiary of ResMed Beteiligungs GmbH
A subsidiary of ResMed R&D Germany GmbH
A subsidiary of ResMed Paris SAS
A subsidiary of ResMed Corp.
A subsidiary of ResMed SAS
A subsidiary of ResMed GmbH and Co KG
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
A subsidiary of ResMed (UK) Limited
A subsidiary of ResMed Limited
A subsidiary of ResMed Asia Operations Pty Ltd
A subsidiary of Healthcare Investment Holdings Ltd
A subsidiary of ResMed European Holdings Ltd
A subsidiary of ResMed Asia Pacific Limited
A subsidiary of ResMed New Zealand Limited
A subsidiary of RMA Inc
The Board of Directors
ResMed Inc.:
C ONSENT OF I NDEPENDENT R EGISTERED P UBLIC A CCOUNTING F IRM
We consent to the incorporation by reference in the registration statements (Nos. 333-08013, 333-88231, 333-115048, 333-140350, 333-140351, 333-156065, 333-
164527, 333-167183, 333-181317, 333-186386 and 333-194225) on Form S-8 and the registration statements (Nos. 333-70500 and 333-100825) on Form S-3 of
ResMed Inc. of our reports dated August 6, 2015, with respect to the consolidated balance sheets of ResMed Inc. and subsidiaries as of June 30, 2015 and 2014,
and 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, 2015, and the related financial statement schedule, and the effectiveness of internal control over financial reporting as of June 30, 2015, which reports
appear in the June 30, 2015 annual report on Form 10-K of ResMed Inc.
E XHIBIT 23.1
/s/ KPMG LLP
San Diego, California
August 6, 2015
E XHIBIT 31.1
Certification of Chief Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Michael J. Farrell, certify that:
1.
2.
3.
4.
I have reviewed this annual report on Form 10-K of ResMed Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
The registrant’s other certifying officer and I, are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal controls over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
Designed such internal controls over financial reporting, or caused such internal controls over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely
to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
August 6, 2015
/s/ MICHAEL J. FARRELL
Michael J. Farrell
Chief executive officer
(Principal Executive Officer)
E XHIBIT 31.2
Certification of Chief Financial Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Brett Sandercock, certify that:
1.
2.
3.
4.
I have reviewed this annual report on Form 10-K of ResMed Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
The registrant’s other certifying officer and I, are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal controls over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
Designed such internal controls over financial reporting, or caused such internal controls over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely
to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
August 6, 2015
/s/ BRETT A. SANDERCOCK
Brett A. Sandercock
Chief financial officer
(Principal Financial Officer and Principal Accounting Officer)
The following certifications are being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350 and in accordance with SEC Release No. 33-8238.
These certifications shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall they be incorporated by
reference in any filing we make under the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation
language in such filing.
Certification of Chief Executive Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of ResMed Inc., a Delaware corporation (the
“Company”), hereby certifies, to his knowledge, that:
(i)
the accompanying Annual Report on Form 10-K of the Company for the year ended June 30, 2015 (the “Report”) fully complies with the requirements of
Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii)
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
E XHIBIT 32.1
Dated: August 6, 2015
/s/ MICHAEL J. FARRELL
Michael J. Farrell
Chief executive officer
(Principal Executive Officer)
A signed original of this written statement required by Section 906 has been provided to ResMed Inc. and will be retained by ResMed Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Certification of Chief Financial Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of ResMed Inc., a Delaware, corporation (the
“Company”), hereby certifies, to his knowledge, that:
(iii)
the accompanying Annual Report on Form 10-K of the Company for the year ended June 30, 2015 (the “Report”) fully complies with the requirements of
Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(iv)
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: August 6, 2015
/s/ BRETT A. SANDERCOCK
Brett A. Sandercock
Chief financial officer
(Principal Financial Officer and Principal Accounting Officer)
A signed original of this written statement required by Section 906 has been provided to ResMed Inc. and will be retained by ResMed Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.