Fiscal Year 2021
2021 LETTER TO SHAREHOLDERS
Dear Shareholders,
Our Mission – to alleviate pain, restore health, and extend life – moves us to do extraordinary things.
While the pandemic continued to impact economies, healthcare systems, companies, and people around the world in FY21, our Mission
endured as our North Star. It enabled us to remain resolute and focused on serving patients as we navigated the year. And as Medtronic
evolved, we remained committed to creating long-term value for our stakeholders around the world.
Focused on creating better patient outcomes, we strive to advance healthcare technology by combining a passion for innovation with a
broad and deep understanding of the human body. By harnessing technologies to create products and solutions, we expand what’s
possible. Our efforts to meet the needs of patients put us at the forefront of turning data and insights into action to make dramatic and
dynamic improvements across care.
Our Board of Directors is actively engaged in strategic oversight, including tracking our progress on our long-term strategies. I want to
thank the Board and our Executive Committee for their guidance and focus, particularly throughout a tumultuous FY21 and the
significant investments and changes we have made to adapt, be nimble, and persevere.
REFLECTING ON A DYNAMIC YEAR
The year behind us held many hurdles, but we didn’t slow down. Our FY21 financial results were strong in light of impacts from the
pandemic. We reported over $30 billion in revenue, an increase of 4 percent as reported or approximately 2 percent on an organic basis.
Our non-GAAP earnings were over $6 billion and diluted EPS was $4.44. While our bottom line decreased 3 percent due to pandemic
pressures, I’m proud of, and grateful for, the 90,000+ employees around the world who dedicated so much time and energy to deliver
these results.
The resolve and dedication of our employees inspires me every day. Thanks to their efforts, we entered FY22 with positive momentum
and strong positions in our markets. And, perhaps more importantly, we started the new year with a renewed commitment to our
Mission and a deepened understanding of the impact we can have during times of great adversity.
ADVANCING OUR BOLD AMBITION
A year ago, we declared a bold ambition: to become the global healthcare technology leader. Medtronic remains committed to
tackling the most complex health and societal challenges facing our world today. In this quest, we’ve made progress, going beyond
devices to develop technology that serves more people in more ways than ever before.
Driven by this ambition, we’re focused on a number of key strategic areas, including creating and disrupting markets, and accelerating
and sustaining innovation-driven revenue growth. By investing in innovation and allocating capital to promising growth opportunities, we
are building our businesses strategically in emerging markets. And we’re maximizing technology’s potential – in areas like AI, data, and
automation – to deliver superior outcomes and experiences for patients.
To enhance the connection between our business and long-term strategies, we introduced a new, streamlined Operating Model to get
closer to our customers and move with greater speed. Our Operating Model created 20 highly focused, empowered, and accountable
Operating Units organized around specific therapies, customers, and markets. With its heightened ownership mindset, this model allows
our teams to be agile, decisive, and move quickly, while enhancing accountability. As a result, we are more competitive, closer to patients
and customers, and more focused on therapy-specific innovation and growth.
To deliver on this transformational structure, we reinvigorated and revived Medtronic’s culture. The Medtronic Mindset builds on our
Mission and core values of integrity, quality, inclusion, and collaboration. It urges us to act boldly, compete to win, move with speed and
decisiveness, foster belonging, and deliver results… the right way. Any transformation of this size takes time, but I’m pleased and
encouraged by the progress to date.
Across the company, employees embraced the transformation. In fact, engagement survey results early in FY22 are among the
strongest we’ve ever seen. The Mindset, coupled with our Operating Model and a reinvigorated brand introduced in late 2021, provides
new energy, enthusiasm, and drive to accomplish our day-to-day work, develop careers, and ultimately, excel in our business
performance.
i
A ROBUST PIPELINE AND DEEP INVESTMENTS IN R&D
In a unique year, Medtronic remained competitive and focused on growth. By meaningfully investing in R&D, our organic pipeline
advanced with more than 230 regulatory approvals in the US, Europe, Japan, and China. Now in FY22, we plan to increase R&D spend by
more than 10 percent, the greatest annual increase on a dollar basis in our history.
Programmatic, multi-year investments in new areas and high-growth potential markets, such as pulsed-field ablation for atrial fibrillation,
are major focuses as we look to the future. We’re building capabilities in data and AI and applying this technology to products in
development, such as our PillCam
TM
Genius. And accelerating progress from acquired technologies – including the recent integration of
Digital Surgery and Medicrea – will further broaden our capabilities to bring data-driven solutions to more patients and caregivers.
To take advantage of significant growth opportunities, we’re allocating capital across our businesses in earnest. Our renal denervation
program for hypertension is expected to be a $2-3 billion market by the end of the decade. Medtronic is poised to disrupt the expected
$1 billion implantable cardiac defibrillator (ICD) market opportunity with our unique extravascular ICD, or EV-ICD. And continued
disruption in the pacemaker market – a market that Medtronic created and first disrupted with our breakthrough leadless pacemaker,
Micra
– is expected to grow to a $2 billion opportunity by 2030. By leveraging capabilities and investing in technologies to capitalize on
these exciting opportunities, we’ll create value and accelerate growth.
TAKING CARE OF OUR COMMUNITIES
Global challenges continued to impact people everywhere this year. As the pandemic rolled into another year, it pressure-tested health
systems, social justice struggles remained, and the ongoing climate crisis grew more intense. The Medtronic Mission guided our
response, and patient and employee welfare remained front-and-center.
Safety and quality: Few things are as integral to our ability to serve patients than our high safety and quality standards. Our role
delivering life-transforming innovation comes with significant responsibility to maintain the trust of our patients, customers, and
stakeholders. Our Mission calls on us “to strive without reserve for the greatest possible reliability and quality in our products; and to be
the unsurpassed standard of comparison,” to improve human welfare. There is nothing more important than patient safety and well-
being.
We recently made the decision to stop HVAD sales based on a body of evidence suggesting our device had a higher frequency of
adverse events. Our focus was on future patients and our desire that they receive a device with demonstrated fewer adverse events,
even if it meant that they would receive a competitor’s device.
Upholding patient safety is our objective every day, and so we continue to invest resources and put the full force of our leadership team
behind accelerated initiatives to evaluate and improve quality and safety systems. Our most recent patient safety improvement initiative
is a priority for our executive team and is notable for its transparency to regulators and stakeholders. This is our most serious
responsibility.
Inclusion, diversity, and equity (ID&E): Medtronic is focused on becoming a more inclusive, diverse, and equitable place to work. While
it was great to be recognized as #11 on Diversity Inc.’s Top 50 Companies for Diversity – moving up 22 spots from the prior year – there
is always room to improve.
To be a company that attracts, develops, and retains top talent from all backgrounds and life experiences, we’re regularly evaluating and
improving hiring practices to foster a more inclusive environment. Incorporating ID&E metrics into our management incentive plans for
FY22 is one way to accelerate progress, because shifting responsibility to business leaders fosters greater accountability to deliver
results. Our goal is to be a global leader and role model in ID&E, not just because it’s good for our business, but it’s good for our people,
and quite simply, it’s the right thing to do.
Climate: Human health hinges upon the health of our environment, which is why climate commitments remain a top priority as
Medtronic continues to evolve and grow. We’ve set aggressive targets around sustainability, including the goal to be carbon neutral in
our operations by 2030. Caring for our planet makes good business sense and meets the expectations of employees and partners. We
have adopted globally recognized disclosure standards and guidelines, including the Global Reporting Initiative (GRI), Sustainability
Accounting Standards Board (SASB) and the Task Force on Climate-related Financial Disclosures (TCFD). By reducing our carbon
footprint, we are investing in the long-term health of our company, our people, and our planet.
COVID-19 response: Medtronic and the Medtronic Foundation invested tens of millions of dollars in global COVID relief efforts in FY21.
New partnerships were forged to significantly increase ventilator production to supply hospitals around the world. As a key member of
the Global Task Force on Pandemic Response, organized by the U.S. Chamber of Commerce and the Business Roundtable, we
collaborated with other Task Force members to supply ventilators to India during a particularly devastating outbreak. And our employees
– many of whom were side-by-side with front-line workers, working diligently to manufacture and deliver life-saving technology – were at
the center of our actions.
ii
Several initiatives, including the Medtronic Employee Assistance Program, were implemented and maintained to help our employees
keep themselves and their families safe. Where permitted, we pursued strategies to increase employee vaccinations globally, including
providing education, ensuring our workforce received vaccinations at no cost to them, and supplementing vaccination offerings with
clinics at some of our large facilities. Paid emergency leave and flexible worktime options, including resources to support caregiving
needs, back-to-school toolkits, and remote learning resources for working parents, ensured our benefit offerings evolved to help our
employees put their families first.
Healthcare technology access: Though we serve millions of patients annually, millions more are left out. To do our part in combatting
pervasive and systemic healthcare inequities, we invested in relief efforts, training, and R&D to better enable technology to drive
improved outcomes for all. It is our duty – both to our patients and those we have not yet reached – to dismantle global disparities in care.
From the beginning, our Mission has rooted us in purpose and guided Medtronic’s decisions. It’s clear that what is best for our world, and
what is best for our business, are the same. Strengthening and advancing our environmental, social, and governance (ESG) strategy is
increasingly important to achieving our bold ambition to be the global healthcare technology leader.
ADVANCING THE MISSION
We’re proud to say we transform the lives of two people every second. But we must do more. The world today demands that
companies help more people, in more meaningful ways, more quickly. While some are benefiting, too many are not.
This past year, we laid the groundwork to seize the vast opportunity ahead of us. Our transformation to achieve our vision is underway,
and I could not be more excited for what’s ahead. Driven by growth strategies, we’re rethinking the speed and scale at which we can
serve the world. We’re resetting our expectations of what innovation and technology can achieve.
Most importantly, we will deliver extraordinary solutions to more patients around the globe, all with an eye on the most important
outcome: to fulfill our Mission to alleviate pain, restore health, and extend life.
Geoff Martha
Chairman and Chief Executive Officer
October 28, 2021
iii
Reconciliation of Non-GAAP Financial Measures
The Shareholder Letter set forth in this Annual Report includes financial measures that are not prepared in accordance with U.S.
generally accepted accounting principles (U.S. GAAP). Management believes that such non-GAAP financial measures provide useful
information to investors regarding the underlying business trends and performance of Medtronic’s ongoing operations. Investors should
consider non-GAAP measures set forth in the Shareholder Letter to be in addition to, and not a substitute for, financial performance
measures prepared in accordance with U.S. GAAP. In addition, such non-GAAP financial measures may not be the same as, or similar to,
measures presented by other companies. Reconciliations of the non-GAAP financial measures referenced in the Shareholder Letter to
the most directly comparable GAAP financial measures are included in the following financial schedules.
MEDTRONIC PLC
WORLD WIDE REVENUE
(1)
(Unaudited)
YEAR-TO-DATE
(2)
REPORTED CONSTANT CURRENCY
(in millions) FY21 FY20 Growth
Currency
Impact
(5)
FY21 Growth
Cardiovascular
(3)
$ 10,772 $ 10,468 2.9% $ 131 $ 10,641 1.7%
Cardiac Rhythm & Heart Failure 5,584 5,141 8.6 79 5,505 7.1
Structural Heart & Aortic 2,834 2,842 (0.3) 38 2,796 (1.6)
Coronary & Peripheral Vascular 2,354 2,486 (5.3) 13 2,341 (5.8)
Medical Surgical 8,737 8,352 4.6 87 8,650 3.6
Surgical Innovations 5,438 5,513 (1.4) 66 5,372 (2.6)
Respiratory, Gastrointestinal, & Renal 3,298 2,839 16.2 22 3,276 15.4
Neuroscience
(4)
8,195 7,725 6.1 75 8,120 5.1
Cranial & Spinal Technologies 4,288 4,082 5.0 34 4,254 4.2
Specialty Therapies 2,307 2,147 7.5 26 2,281 6.2
Neuromodulation 1,601 1,497 6.9 16 1,585 5.9
Diabetes 2,413 2,368 1.9 37 2,376 0.3
TOTAL $ 30,117 $ 28,913 4.2% $ 331 $ 29,786 3.0%
(1) The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.
(2) Fiscal year 2021 was a 53-week fiscal year, with the extra week occurring in the first fiscal month of the first quarter and included in reported
year-to-date results. While it is difficult to calculate the impact of the extra week, the Company estimates the extra week benefited year-to-date
constant currency growth by approximately $360 to $390 million. Year-to-date revenue also includes $15 million of inorganic revenue related to the
Titan Spine acquisition, which is included in the reported results of the Cranial & Spinal Technologies division within Neuroscience. When excluding
the impact of currency, inorganic Titan Spine revenue, and the estimated impact of the extra week, year-to-date revenue for fiscal year 2021
increased approximately 2 percent organic.
(3) In the fourth quarter of fiscal year 2021, the Company realigned its divisions within Cardiovascular. As a result, fiscal year 2020 results have been
recast to adjust for this realignment.
(4) In the first quarter of fiscal year 2021, the Company realigned its divisions with Neuroscience. As a result, fiscal year 2020 results have been recast to
adjust for this realignment.
(5) The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.
iv
MEDTRONIC PLC
GAAP TO NON-GAAP RECONCILIATIONS
(1)
(Unaudited)
Fiscal year ended April 30, 2021
(in millions, except per share data) Net Sales
Cost of
Products
Sold
Gross
Margin
Percent
Operating
Profit
Operating
Profit
Percent
Income
Before
Income
Taxes
Net Income
attributable
to Medtronic
Diluted
EPS
Effective
Tax Rate
GAAP $ 30,117 $ 10,483 65.2% $ 4,484 14.9% $ 3,895 $ 3,606 $ 2.66 6.8%
Non-GAAP Adjustments:
Restructuring and associated
costs
(2)
(128) 0.4 617 2.0 617 489 0.36 20.7
Acquisition-related items
(3)
(15) (15) (15) 4 126.7
Certain litigation charges 118 0.4 118 95 0.07 19.5
(Gain)/loss on minority
investments
(4)
(61) (57) (0.04)
IPR&D charges
(5)
31 0.1 31 25 0.02 19.4
Impairment charges
(6)
76 0.3 76 68 0.05 10.5
Medical device regulations
(7)
(45) 0.1 83 0.3 83 68 0.05 18.1
Debt tender premium and other
charges
(8)
308 248 0.18 19.5
Amortization of intangible
assets 1,783 5.9 1,783 1,500 1.11 15.9
Certain tax adjustments, net
(9)
(41) (0.03)
Non-GAAP $ 30,117 $ 10,295 65.8% $ 7,177 23.8% $ 6,835 $ 6,005 $ 4.44 11.8%
Currency impact (331) (191) 0.3 296 1.3 0.19
Currency Adjusted $ 29,786 $ 10,104 66.1% $ 7,473 25.1% $ 4.63
Fiscal year ended April 24, 2020
(in millions, except per share data) Net Sales
Cost of
Products
Sold
Gross
Margin
Percent
Operating
Profit
Operating
Profit
Percent
Income
Before
Income
Taxes
Net Income
attributable
to Medtronic
Diluted
EPS
Effective
Tax Rate
GAAP $ 28,913 $ 9,424 67.4% $ 4,791 16.6% $ 4,055 $ 4,789 $ 3.54 (18.5)%
Non-GAAP Adjustments:
Restructuring and associated costs
(2)
(155) 0.6 441 1.5 441 372 0.28 15.6
Acquisition-related items
(10)
(5) 66 0.2 66 53 0.04 19.7
Certain litigation charges 313 1.1 313 254 0.19 18.8
(Gain)/loss on minority investments
(4)
19 22 0.02 (15.8)
Debt tender premium and other charges
(11)
(7) 406 320 0.24 21.2
Medical device regulations
(7)
(20) 0.1 48 0.2 48 42 0.03 12.5
Exit of businesses
(12)
52 0.2 52 40 0.03 23.1
IPR&D charges
(5)
25 0.1 25 22 0.02 12.0
Contribution to Medtronic Foundation 80 0.3 80 62 0.05 22.5
Amortization of intangible assets 1,756 6.1 1,756 1,472 1.09 16.2
Certain tax adjustments, net
(13)
(1,242) (0.92)
Non-GAAP $ 28,913 $ 9,244 68.0% $ 7,565 26.2% $ 7,261 $ 6,206 $ 4.59 14.3%
(1) The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.
(2) Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program and
consulting expenses.
(3) The charges primarily include business combination transaction-related costs, changes in fair value of contingent consideration, and a change in
amounts accrued for certain contingent liabilities for recent acquisitions.
v
(4) We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense
have a direct correlation to our ongoing or future business operations.
(5) The charges represent acquired IPR&D in connection with asset acquisitions and certain license payments for unapproved technology.
(6) The charges relate to the abandonment of certain intangible assets in our Neuroscience segment.
(7) The charges represent estimated incremental costs of complying with the new European Union medical device regulations for previously registered
products and primarily include charges for contractors supporting the project and other direct third-party expenses.
(8) The charges relate to the early redemption of approximately $6.0 billion of debt.
(9) The net benefit primarily relates to the finalization of an audit at the IRS Appellate level for fiscal years 2012 through 2014 and the capitalization of
certain research and development costs for U.S. income tax purposes, which are partially offset by the impact of an intercompany sale of assets, and
a tax basis adjustment and amortization of previously established deferred tax assets from intercompany intellectual property transactions.
(10) The charges primarily include costs incurred in connection with legacy-Covidien enterprise resource planning deployment activities, business
combination related costs, and changes in fair value of contingent consideration.
(11) The charges, which include $413 million recognized in interest expense and ($7 million) recognized in other operating expense, net, primarily relate to
the early redemption of approximately $5.2 billion of debt.
(12) The net charges relate to the exit of businesses and are primarily comprised of intangible asset impairments.
(13) The net benefit primarily relates to the release of a valuation allowance on certain net operating losses and the impact of tax reform in Switzerland
and the United States.
vi
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
Annual report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934.
For the fiscal year ended April 30, 2021.
Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
For the transition period from __________ to __________
Commission File No. 1-36820
Medtronic plc
(Exact name of registrant as specified in its charter)
Ireland 98-1183488
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)
20 On Hatch, Lower Hatch Street Dublin 2, Ireland
(Address of principal executive offices)
+353 1 438-1700
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol Name of each exchange on which registered
Ordinary shares, par value $0.0001 per share
MDT New York Stock Exchange
0.00% Senior Notes due 2022
MDT/22B New York Stock Exchange
0.375% Senior Notes due 2023
MDT/23B New York Stock Exchange
0.000% Senior Notes due 2023
MDT/23C New York Stock Exchange
0.25% Senior Notes due 2025
MDT/25 New York Stock Exchange
0.000% Senior Notes due 2025
MDT/25A New York Stock Exchange
1.125% Senior Notes due 2027
MDT/27 New York Stock Exchange
0.375% Senior Notes due 2028
MDT/28 New York Stock Exchange
1.625% Senior Notes due 2031
MDT/31 New York Stock Exchange
1.00% Senior Notes due 2031
MDT/31A New York Stock Exchange
0.750% Senior Notes due 2032
MDT/32 New York Stock Exchange
2.250% Senior Notes due 2039
MDT/39A New York Stock Exchange
1.50% Senior Notes due 2039
MDT/39B New York Stock Exchange
1.375% Senior Notes due 2040
MDT/40A New York Stock Exchange
1.75% Senior Notes due 2049
MDT/49 New York Stock Exchange
1.625% Senior Notes due 2050
MDT/50 New York Stock Exchange
Securities registered pursuant to section 12(g) of the Act:
None
Indicate by check mark Yes No
• if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
• if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act.
• 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.
• whether the registrant has submitted electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§229.405 of this chapter) during the preceding 12 months (or for such
shorter period that the registrant was required to submit such files).
• whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging
growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in
Rule 12b-2 of the Exchange Act.
Large accelerated filer Accelerated filer Non-accelerated filer Smaller reporting company Emerging growth company
• If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
• whether the registrant has filed a report on and attestation to its management’s assessment of the
effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15
U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
• whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Aggregate market value of voting and non-voting common equity of Medtronic plc held by non-affiliates of the registrant as of October 30, 2020,
based on the closing price of $100.57 as reported on the New York Stock Exchange: approximately $135.3 billion. Number of Ordinary Shares
outstanding on June 23, 2021: 1,343,904,180
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s Proxy Statement for its 2021 Annual General Meeting are incorporated by reference into Part III hereof.
TABLE OF CONTENTS
Item Description Page
PART I 11
1. Business ...............................................................................................11
1A. Risk Factors ............................................................................................21
1B. Unresolved Staff Comments .............................................................................33
2. Properties ..............................................................................................34
3. Legal Proceedings .......................................................................................34
4. Mine Safety Disclosures ..................................................................................34
PART II 35
5. Market for Medtronic’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities ....35
6. (Reserved) .............................................................................................36
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations .........................37
7A. Quantitative and Qualitative Disclosures About Market Risk ...................................................56
8. Financial Statements and Supplementary Data ..............................................................57
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure .......................109
9A. Controls and Procedures ................................................................................109
9B. Other Information ......................................................................................109
PART III
111
10. Directors, Executive Officers, and Corporate Governance ...................................................111
11. Executive Compensation ...............................................................................112
12. Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters .............113
13. Certain Relationships and Related Transactions, and Director Independence ..................................113
14. Principal Accounting Fees and Services ...................................................................113
PART IV
114
15. Exhibits and Financial Statement Schedules ...............................................................114
16. Form 10-K Summary ...................................................................................119
Signatures ............................................................................................120
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K, and other written reports of
Medtronic public limited company, organized under the laws of
Ireland (together with its consolidated subsidiaries, Medtronic,
the Company, or we, us, or our), and oral statements made by or
with the approval of one of the Company’s executive officers
from time to time, may include “forward-looking” statements. All
statements other than statements of historical fact contained in
this Annual Report on Form 10-K, including statements
regarding our future results of operations and financial position,
business strategy and plans, objectives of management for
future operations and current expectations or forecasts of
future results, are forward-looking statements. These
statements involve known and unknown risks, uncertainties, and
other important factors that may cause our actual results,
performance, or achievements to be materially different from
any future results, performance, or achievements expressed or
implied by the forward-looking statements. Our forward-looking
statements may include statements related to our growth and
growth strategies, developments in the markets for our
products, therapies and services, financial results, product
development launches and effectiveness, research and
development strategy, regulatory approvals, competitive
strengths, the potential or anticipated direct or indirect impact of
COVID-19 on our business, results of operations and/or financial
condition, restructuring and cost-saving initiatives, intellectual
property rights, litigation and tax matters, governmental
proceedings and investigations, mergers and acquisitions,
divestitures, market acceptance of our products, therapies and
services, accounting estimates, financing activities, ongoing
contractual obligations, working capital adequacy, value of our
investments, our effective tax rate, our expected returns to
shareholders, and sales efforts. In some cases, such statements
may be identified by the use of terminology such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “forecast,” “intend,”
“looking ahead,” “may,” “plan,” “possible,” “potential,” “project,”
“should,” “will,” and similar words or expressions. Forward-looking
statements in this Annual Report include, but are not limited to,
statements regarding our ability to drive long-term shareholder
value, development and future launches of products and
continued or future acceptance of products, therapies and
services in our segments; expected timing for completion of
research studies relating to our products; market positioning and
performance of our products, including stabilization of certain
product markets; divestitures and the potential benefits thereof;
the costs and benefits of integrating previous acquisitions;
anticipated timing for United States (U.S.) Food and Drug
Administration (U.S. FDA) and non-U.S. regulatory approval of
new products; increased presence in new markets, including
markets outside the U.S.; changes in the market and our market
share; acquisitions and investment initiatives, as well as
integration of acquired companies into our operations; the
resolution of tax matters; the effectiveness of our development
activities in reducing patient care costs and hospital stay lengths;
our approach towards cost containment; our expectations
regarding healthcare costs, including potential changes to
reimbursement policies and pricing pressures; our expectations
regarding changes to patient standards of care; our ability to
identify and maintain successful business partnerships; the
elimination of certain positions or costs related to restructuring
initiatives; outcomes in our litigation matters and governmental
proceedings and investigations; general economic conditions;
the adequacy of available working capital and our working capital
needs; our payment of dividends and redemption of shares; the
continued strength of our balance sheet and liquidity; our
accounts receivable exposure; and the potential impact of our
compliance with governmental regulations and accounting
guidance.
We have based these forward-looking statements largely on our
current expectations and projections about future events and
financial trends that we believe may affect our business, results
of operations, financial condition, and cash flows. These forward-
looking statements speak only as of the date of this Annual
Report on Form 10-K and are subject to a number of risks,
uncertainties and assumptions described in the “Risk Factors”
section and elsewhere in this Annual Report on Form 10-K.
Because forward-looking statements are inherently subject to
risks and uncertainties, some of which cannot be predicted or
quantified, you should not rely on these forward-looking
statements as predictions of future events. One must carefully
consider forward-looking statements and understand that such
forward-looking statements are inherently subject to risks and
uncertainties, some of which cannot be predicted or quantified,
and involve a variety of risks and uncertainties, known and
unknown, including, among others, those discussed in the
sections entitled “Government Regulation” within “Item 1.
Business” and “Item 1A. Risk Factors” in this Annual Report on
Form 10-K, as well as those related to:
the COVID-19 pandemic;
competition in the medical device industry;
reduction or interruption in our supply;
laws and governmental regulations;
quality problems;
liquidity shortfalls;
decreasing prices and pricing pressure;
fluctuations in currency exchange rates;
changes in applicable tax rates;
positions taken by taxing authorities;
adverse regulatory action;
delays in regulatory approvals;
MEDTRONIC PLC 2021 Form 10-K 9
litigation results;
self-insurance;
commercial insurance;
healthcare policy changes;
international operations;
cybersecurity incidents;
failure to complete or achieve the intended benefits of
acquisitions or divestitures; or
disruption of our current plans and operations.
Consequently, no forward-looking statement may be
guaranteed, and actual results may vary materially from those
projected in the forward-looking statements. We intend to take
advantage of the Safe Harbor provisions of the Private Securities
Litigation Reform Act of 1995 regarding our forward-looking
statements, and are including this sentence for the express
purpose of enabling us to use the protections of the safe harbor
with respect to all forward-looking statements. While we may
elect to update these forward-looking statements at some point
in the future, whether as a result of any new information, future
events, or otherwise, we have no current intention of doing so
except to the extent required by applicable law.
10
MEDTRONIC PLC 2021 Form 10-K
PART I
Item 1. Business
72 Million +
Patients
Served
Employees PatentsResearch and
Development
Spend
Countries in
Which We
Operate
150+ 90,000+ 49,000+$2.5 Billion
Medtronic plc, headquartered in Dublin, Ireland, is among the
world’s largest medical technology, services, and solutions
companies. Medtronic was founded in 1949 and today serves
healthcare systems, physicians, clinicians, and patients in more
than 150 countries worldwide. We remain committed to a
mission written by our founder in 1960 that directs us “to
contribute to human welfare by the application of biomedical
engineering in the research, design, manufacture, and sale of
products to alleviate pain, restore health, and extend life.”
Our Mission – to alleviate pain, restore health, and extend life – is
one of our most powerful assets. We remain committed to being
recognized as a company of dedication, honesty, integrity, and
service. Building on this strong foundation, we are embracing our
role as a healthcare technology leader and evolving our business
strategy in four key areas:
Leveraging our pipeline to win market share: The combination
of our strong base business, recent product launches and
robust pipeline is expected to continue accelerating our
growth over both the near-and long-term. We aim to bring
inventive and disruptive technology to large healthcare
opportunities which enables us to better meet patient needs.
Patients around the world deserve access to our life-saving
products, and we are driven to use our local presence and
scale to increase the adoption of our products and services in
markets around the globe.
Serving more patients by accelerating innovation driven
growth and delivering shareholder value: We listen to our
patients, customers, and employees to better understand the
challenges they face. From the patient journey, to creating
agile partnerships that produce novel solutions, to making it
easier for our customers to deploy our therapies – everything
we do is anchored in deep insight, and creates simpler,
superior experiences for everyone.
Creating and disrupting markets with our technology by
putting the “tech” in medtech: We are confident in our ability
to maximize new technology, artificial intelligence (AI), and
data and analytics to tailor therapies in real-time, facilitating
remote monitoring and care delivery that conveniently
manages conditions, and creates new standards of care.
Empowering our operating units to become more nimble and
more competitive: Our new operating model simplifies our
organization in order to accelerate decision making, improve
commercial execution, and more effectively leverage the
scale of our company.
Our new operating model was effective February 1, 2021. The
new operating model moved from a Group structure to a
Portfolio structure: Cardiovascular Portfolio (formerly Cardiac
and Vascular Group), Neuroscience Portfolio (formerly
Restorative Therapies Group), Medical Surgical Portfolio
(formerly Minimally Invasive Therapies Group), and Diabetes
Operating Unit (formerly Diabetes Group). There were no
changes to the operating and reportable segments as a result of
this new operating model.
We have four operating and reportable segments that primarily
develop, manufacture, distribute, and sell device-based medical
therapies and services: the Cardiovascular Portfolio, the Medical
Surgical Portfolio, the Neuroscience Portfolio, and the Diabetes
Operating Unit. For more information regarding our segments,
please see Note 19 to the consolidated financial statements in
“Item 8. Financial Statements and Supplementary Data” in this
Annual Report on Form 10-K.
MEDTRONIC PLC 2021 Form 10-K 11
PART I
Item 1 Business
CARDIOVASCULAR PORTFOLIO
The Cardiovascular Portfolio is made up of the Cardiac Rhythm & Heart Failure, Structural Heart & Aortic, and Coronary & Peripheral
Vascular divisions. The primary medical specialists who use our Cardiovascular products include electrophysiologists, implanting
cardiologists, heart failure specialists, cardiovascular, cardiothoracic, and vascular surgeons, and interventional cardiologists and
radiologists.
Cardiac Rhythm & Heart Failure
Our Cardiac Rhythm & Heart Failure division includes the
following Operating Units: Cardiac Rhythm Management,
Cardiac Ablation Solutions, Cardiovascular Diagnostics, and
Mechanical Circulatory Support. The division develops,
manufactures, and markets products for the diagnosis,
treatment, and management of heart rhythm disorders and
heart failure. Our products include implantable devices, leads and
delivery systems, products for the treatment of atrial fibrillation
(AF), products designed to reduce surgical site infections,
information systems for the management of patients with
Cardiac Rhythm & Heart Failure devices, and an integrated health
solutions business. Principal products and services offered
include:
Implantable cardiac pacemakers including the Azure MRI
SureScan, Adapta, Advisa MRI SureScan, and the Micra
Transcatheter Pacing System. The Micra Transcatheter
Pacing System, which is leadless and does not have a
subcutaneous device pocket like a conventional pacemaker,
includes the MicraVR and the Micra AV which can treat
patients with atrioventricular block.
Implantable cardioverter defibrillators (ICDs), including the
Visia AF, Evera MRI SureScan, and the Cobalt and Crome
portfolio of BlueSync-enabled ICDs, as well as defibrillator
leads, including the Sprint Quattro Secure lead.
Implantable cardiac resynchronization therapy devices
(CRT-Ds and CRT-Ps) including the Claria/Amplia/Compia
family of MRI Quad CRT-D SureScan systems and the Cobalt
and Crome portfolio of BlueSync-enabled CRT-Ds, as well as
the Percepta/Serena/Solara family of MRI Quad CRT-P
SureScan systems.
AF ablation products including the Arctic Front Cardiac
CryoAblation Catheter System, designed for pulmonary vein
isolation in the treatment of patients with drug refractory
paroxysmal AF, as well as the DiamondTemp Ablation system,
which is the first U.S. FDA-approved, temperature controlled,
irrigated radiofrequency ablation system with diamonds
available to deliver ablations.
Insertable cardiac monitoring systems including the Reveal
LINQ and LINQ II. These devices are for patients with
abnormal heart rhythms who experience infrequent
symptoms including dizziness, palpitations, syncope (fainting)
and chest pain, thereby requiring long-term monitoring or
ongoing management. The LINQ II device offers remote
programming, improved device longevity, and enhanced
accuracy to correctly detect abnormal heart rhythms,
simplifying diagnosis and monitoring of patients.
Mechanical circulatory support products including
miniaturized implantable heart pumps, or ventricular assist
devices, patient accessories and surgical tools to treat
patients suffering from advanced heart failure.
TYRX products including the Cardiac and Neuro Absorbable
Antibacterial Envelopes, which are designed to stabilize
electronic implantable devices and help prevent infection
associated with implantable pacemakers, and defibrillators.
Remote monitoring services and patient-centered software
to enable efficient care coordination and specialized
telehealth nurse support as well as services related to hospital
operational efficiency.
Structural Heart & Aortic
Our Structural Heart & Aortic division includes the following
Operating Units: Structural Heart & Aortic and Cardiac Surgery.
The division includes therapies to treat heart valve disorders and
aortic disease. Our devices include products for the repair and
replacement of heart valves, perfusion systems, positioning and
stabilization systems for beating heart revascularization surgery,
surgical ablation products, and comprehensive line of products
and therapies to treat aortic disease, such as aneurysms,
dissections, and transections. Principal products offered include:
CoreValve family of aortic valves, including the Evolut R, Evolut
PRO, and Evolut PRO+ systems for transcatheter aortic valve
replacement.
Surgical valve replacement and repair products for damaged
or diseased heart valves, including both tissue and mechanical
valves, blood-handling products that form a circulatory
support system to maintain and monitor blood circulation and
coagulation status, oxygen supply, and body temperature
during arrested heart surgery, and surgical ablation systems
and positioning and stabilization technologies.
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MEDTRONIC PLC 2021 Form 10-K
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Item 1 Business
Endovascular stent grafts and accessories including the
Endurant II Stent Graft System for the treatment of abdominal
aortic aneurysms, the Valiant Captivia Thoracic Stent Graft
System for thoracic endovascular aortic repair procedures,
and the Heli-FX EndoAnchor System.
Coronary & Peripheral Vascular
Our Coronary & Peripheral Vascular division includes the
following Operating Units: Coronary & Renal Denervation and
Peripheral Vascular Health. The division is comprised of a
comprehensive line of products and therapies to treat coronary
artery disease as well as peripheral vascular disease and venous
disease. Our products include coronary stents and related
delivery systems, including a broad line of balloon angioplasty
catheters, guide catheters, guide wires, diagnostic catheters,
and accessories, peripheral drug coated balloons, stent and
angioplasty systems, carotid embolic protection systems for the
treatment of vascular disease outside the heart, and products
for superficial and deep venous disease. Principal products
offered include:
Percutaneous Coronary Intervention products including our
Resolute Onyx drug-eluting stent, Euphoria balloons, and
Launcher guide catheters.
Percutaneous angioplasty balloons including the IN.PACT
family of drug-coated balloons, vascular stents including the
Abre venous stent, directional atherectomy products
including the HawkOne directional atherectomy system, and
other procedure support tools.
Products to treat superficial venous diseases in the lower
extremities including the ClosureFast radiofrequency ablation
system and the VenaSeal Closure System.
MEDICAL SURGICAL PORTFOLIO
The Medical Surgical Portfolio is made up of the Surgical Innovations and Respiratory, Gastrointestinal, & Renal divisions. Products and
therapies of this group are used primarily by healthcare systems, physicians’ offices, ambulatory care centers, and other alternate site
healthcare providers. While less frequent, some products and therapies are also used in home settings.
Surgical Innovations
Our Surgical Innovations division includes the following
Operating Units: Surgical Innovations and Surgical Robotics. The
division develops, manufactures, and markets advanced and
general surgical products including surgical stapling devices,
vessel sealing instruments, wound closure, electrosurgery
products, surgical artificial intelligence (AI) and robotic-assisted
surgery products, hernia mechanical devices, mesh implants,
gynecology and lung products, and therapies to treat diseases
and conditions that are typically, but not exclusively, addressed
by surgeons. Principal products and services offered include:
Advanced stapling and energy products, including the
Tri-Staple technology platform for endoscopic stapling,
including the Endo GIA reloads and reinforced reloads with
Tri-Staple Technology and the Endo GIA ultra universal stapler,
the Signia Powered Stapling System, the LigaSure Exact
Dissector and L-Hook Laparoscopic Sealer/Divider, and the
Sonicision curved jaw cordless ultrasonic dissection system.
Electrosurgical hardware and instruments, including the
Valleylab FT10 energy platform, and the Force TriVerse
electrosurgical pencils, and surgical AI, data and analytics, and
digital education and training to support robotic assisted
surgery platform.
Products designed for the treatment of hernias, including the
AbsorbaTack absorbable mesh fixation device for hernia repair,
the Symbotex composite mesh for surgical laparoscopic and
open ventral hernia repair, and Parietex ProGrip, a self-gripping,
biocompatible solution for inguinal hernias.
Respiratory, Gastrointestinal, & Renal
Our Respiratory, Gastrointestinal, & Renal division includes the
following Operating Units: Respiratory Interventions, Patient
Monitoring, Gastrointestinal, and Renal Care Solutions. The
division develops, manufactures, and markets products in the
emerging fields of minimally invasive gastrointestinal and
hepatologic diagnostics and therapies, patient monitoring,
respiratory interventions including airway management and
ventilation therapies, and for the treatment of renal disease.
Principal products and services offered include:
Gastrointestinal and endoscopy products, including the
PillCam capsule endoscopy systems, the Bravo calibration-
free reflux testing systems, the EndoFLIP imaging systems,
the Emprint ablation system with Thermosphere Technology,
the ManoScan Bravo system, the Barrx platform through
ablation with the Barrx 360 Express catheter, the GI Genius
intelligent endoscopy module, the Cool-tip radiofrequency
ablation system, and the HET Bipolar System.
MEDTRONIC PLC 2021 Form 10-K 13
PART I
Item 1 Business
Airway, ventilation, and inhalation therapies products, including
the Puritan Bennett 980 and 840 ventilators, the Newport
e360 and HT70 ventilators, the TaperGuard Evac tube, Shiley
Endotracheal Tubes, Shiley Tracheostomy Tubes, McGRATH
MAC video laryngoscopes, and DAR Filters.
Products focused on patient monitoring, including
Microstream capnography monitors, Nellcor pulse oximetry
monitors, INVOS cerebral/somatic oximetry systems, Vital
Sync remote monitoring, WarmTouch convective warming,
and Bispectral Index (BIS) brain monitoring technology.
Products providing solutions for the treatment of renal
disease, including Palindrome, Mahurkar and Mahurkar Elite
Dialysis Access Catheters for renal therapy, Argyle peritoneal
dialysis catheters, and other products designed for use in
treatment of both acute and chronic renal failure conditions.
NEUROSCIENCE PORTFOLIO
The Neuroscience Portfolio is made up of the Cranial & Spinal Technologies, Specialty Therapies, and Neuromodulation divisions. The
primary medical specialists who use the products of this group include spinal surgeons, neurosurgeons, neurologists, pain management
specialists, anesthesiologists, orthopedic surgeons, urologists, urogynecologists, interventional radiologists, and ear, nose, and throat
specialists.
Cranial & Spinal Technologies
Our Cranial & Spinal Technologies division and Operating Unit
develops, manufactures, and markets an integrated portfolio of
devices and therapies for surgical technologies designed to
improve the precision and workflow of neuro procedures, and a
comprehensive line of medical devices and implants used in the
treatment of the spine and musculoskeletal system. The division
also provides biologic solutions for the orthopedic and dental
markets and offers unique and highly differentiated imaging,
navigation, power instruments, nerve monitoring, and robotic
guidance systems used in spine and cranial procedures. Principal
products and services offered include:
Neurosurgery products, including platform technologies,
implant therapies, and advanced energy products. Our
StealthStation S8 Navigation System, Stealth Autoguide
cranial robotic guidance platform, and O-arm Imaging System
are platforms used in cranial, spinal, sinus, and orthopedic
procedures. Our Mazor X robotic guidance systems are used
in robot-assisted spine procedures and combine the
best-in-class robotics and navigation capability. Our Midas Rex
Surgical Drills, including our new MR8 high-speed drill system,
are used in cranial, spinal, ENT, and orthopedic procedures.
Our cerebrospinal fluid (CSF) Management Portfolio is used in
treating hydrocephalus and other conditions impacting the
intracranial pressure, and our Visualase MRI-guided laser
ablation is used in cranial procedures. Our PEAK Surgery
System is a tissue dissection system that consists of the PEAK
PlasmaBlade and PULSAR Generator and is cleared for use in a
variety of settings, including plastic reconstructive surgery,
general surgery, and certain conditions of ENT. Our
Aquamantys Sealers use patented transcollation technology
to provide haemostatic sealing of soft tissue and bone and are
cleared for use in a variety of surgical procedures, including
orthopedic surgery, spine, solid organ resection and thoracic
procedures.
Products to treat a variety of conditions affecting the spine,
including degenerative disc disease, spinal deformity, spinal
tumors, fractures of the spine, and stenosis. These products
include our CD HORIZON SOLERA system, T2
STRATOSPHERE, and the CLYDESDALE, and ELEVATE
interbody spacers. These products also include titanium
interbody implants and surface technologies, such as our
Adaptix interbody system and the Titan Interbody Fusion
Device with NanoLOCK technology.
Products that facilitate less invasive thoracolumbar surgeries,
including the CD HORIZON SOLERA VOYAGER and
LONGITUDE Percutaneous Fixation Systems.
Products to treat conditions in the cervical region of the spine,
including the ZEVO Anterior Cervical Plate System, the
INFINITY OCT System, and PRESTIGE LP Cervical Artificial
Discs.
Biologic solutions products, including our INFUSE Bone Graft
(InductOs in the European Union (E.U.)), which contains a
recombinant human bone morphogenetic protein, rhBMP-2,
for certain spinal, trauma, and oral maxillofacial applications.
Demineralized Bone Matrix products, including MAGNIFUSE,
GRAFTON/GRAFTON PLUS, COREX, and PROGENIX, and the
MASTERGRAFT family of synthetic bone graft products –
Matrix, Putty, and Granules.
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MEDTRONIC PLC 2021 Form 10-K
PART I
Item 1 Business
Specialty Therapies
Our Specialty Therapies division includes the following Operating
Units: Neurovascular, Ear, Nose, and Throat (ENT), and Pelvic
Health. The division develops, manufactures, and markets
products and therapies to treat diseases of ENT, patients
afflicted with Acute Ischemic and Hemorrhagic stroke, and help
control the systems of overactive bladder, (non-obstructive)
urinary retention, and chronic fecal incontinence. Principal
products and services offered include:
Pelvic health and gastric therapies products, including our
InterStim, InterStim Micro, and InterStim II neurostimulators,
and InterStim SureScan MRI leads, to help control the systems
of overactive bladder, (non-obstructive) urinary retention, and
chronic fecal incontinence. Our NURO System delivers
Percutaneous Tibial Neuromodulation therapy to treat
overactive bladder and associated symptoms of urinary
urgency, urinary frequency, and urge incontinence. Our
Enterragastric neurostimulator (approved under a
Humanitarian Device Exemption (HDE) in the U.S.) is used for
the treatment of chronic, intractable nausea and vomiting due
to gastroparesis.
ENT products, including the Straightshot M5 Microdebrider
Handpiece, the IPC system, NIM Nerve Monitoring Systems,
FUSION Compact and StealthStation ENT Navigation System,
as well as products for hearing restoration and obstructive
sleep apnea.
Neurovascular products to treat diseases of the vasculature in
and around the brain. This includes coils, neurovascular stent
retrievers, and flow diversion products, as well as access and
delivery products to support procedures. Products also
include the Pipeline Flex Embolization Devices, endovascular
treatments for large or giant wide-necked brain aneurysms,
the portfolio of Solitaire revascularizationdevices for
treatment of acute ischemic stroke, the Riptide Aspiration
System and a portfolio of associated access catheters
including our React aspiration catheters also for the treatment
of acute ischemic stroke.
Neuromodulation
Our Neuromodulation division and Operating Unit develops,
manufactures, and markets spinal cord stimulation systems,
implantable drug infusion systems for chronic pain, as well as
interventional products. Principal products and services offered
include:
Spinal cord stimulation products, including rechargeable and
non-rechargeable devices and a large selection of leads used
to treat chronic back and/or limb pain. This includes the Intellis
Spinal Cord Stimulation System, with AdaptiveStim and
SureScan MRI Technology, DTM (differential target
multiplexed) proprietary waveform, the Evolve workflow
algorithm, and Snapshot reporting. Products also include our
RestoreSensor (rechargeable) SureScan MRI neurostimulation
system, with its proprietary AdaptiveStim technology.
Brain modulation products, including those for the treatment
of the disabling symptoms of Parkinson’s disease, essential
tremor, refractory epilepsy, severe, treatment-resistant
obsessive compulsive disorder (approved under a HDE in the
U.S.), and chronic, intractable primary dystonia (approved
under a HDE in the U.S.). Specifically, this includes our family of
Activa Neurostimulators, including Activa SC (single-channel
primary cell battery), Activa PC (dual channel primary cell
battery), and Activa RC (dual channel rechargeable battery).
This also includes our Percept PC Neurostimulator DBS
system with BrainSense technology.
Implantable drug infusion systems, including our SynchroMed
II Implantable Infusion System, that deliver small quantities of
drug directly into the intrathecal space surrounding the spinal
cord.
Interventional products, including the Xpander II Balloon
Kyphoplasty system, the Kyphon-V vertebroplasty system
and the OsteoCool RF Tumor ablation system.
The Accurian nerve ablation system, which conducts radio
frequency ablation of nerve tissues.
DIABETES OPERATING UNIT
The Diabetes Operating Unit develops, manufactures, and markets products and services for the management of Type 1 and Type 2
diabetes. The primary medical specialists who use and/or prescribe our Diabetes products are endocrinologists and primary care
physicians.
MEDTRONIC PLC 2021 Form 10-K 15
PART I
Item 1 Business
Principal products and services offered include:
Insulin pumps and consumables, including the MiniMed 770G
system and MiniMed 780G system, which are all powered by
SmartGuard technology. The MiniMed 770G system provides
smartphone and Bluetooth connectivity, continuously delivers
background insulin, monitors sugar levels, and an expanded
age indication to ages two and up. The MiniMed 780G
enhances the insulin pump systems by including automatic
correction boluses and an adjustable glucose target down to
100 mg/dl.
Continuous glucose monitoring (CGM) systems and sensors,
including the Guardian Connect smart CGM system and the
Guardian Sensor 3, are products worn by patients capturing
glucose data to reveal patterns and potential problems, such
as hyperglycemic and hypoglycemic episodes.
The InPen smart insulin pen system that combines a reusable
Bluetooth-enabled insulin pen with an intuitive mobile app that
helps users administer the appropriate insulin dose. The InPen
application was integrated with our CGM data to provide real-
time CGM readings alongside insulin dose information.
Consumables and supplies, including infusion sets.
HUMAN CAPITAL
Medtronic Workforce Overview
Medtronic’s employees deliver on our Mission every day. We
strive to be the employer of choice for the best and brightest
global talent, where employees can grow and develop fulfilling
careers. We aspire to create a truly inclusive, diverse, and
equitable workplace that fosters innovation and creativity, and
where every employee feels a sense of belonging and well-being.
More than 99 percent of Medtronic’s 90,000+ employees work
full-time. Forty-four percent of our employees are based in the
U.S. or Puerto Rico.
Inclusion, Diversity & Equity
We believe that improving health for people from all walks of life
depends on our ability to unleash the creative power of our
diverse global employees. By breaking down barriers to Inclusion,
Diversity and Equity, we open doors for everyone, driving
progress and prosperity around the world. As of the end of fiscal
year 2021, 38 percent of our U.S. workforce is ethnically diverse;
women comprise 50 percent of our global workforce; and
40 percent of our people leaders, manager level and above, are
women. Additionally, Medtronic employee resource groups
(ERGs) are employee-led affinity groups that provide career
development and networking opportunities for members and
strengthen ties between employees of many different
backgrounds, cultures, and interests. In fiscal year 2021, there
were 12 ERGs across 70 countries with more than 26,000
members.
Pay Equity
For fiscal year 2021, in the United States we have achieved 100%
pay equity for gender and 99% pay equity for ethnically diverse
employees. Globally we have achieved 99% pay equity for
gender. We are actively working to close any remaining pay gaps
by continuing to expand the annual pay equity analyses for each
country in which we operate.
Workforce Compensation
Our compensation framework is designed to celebrate the value
and contributions of our employees. We aim to create a feeling
of personal and professional security at Medtronic and are
committed to transparent communications on compensation.
Our competitive approach to compensation reflects industry
benchmarks and local market standards. Our programs include
annual and long-term incentives that provide the means to share
in the company’s success. To attract the best leaders, we offer
competitive benefits and cash and equity incentives. We reward
high-performing employees with an ownership stake in the
company through restricted stock, and all employees have the
opportunity to purchase stock at a discount.
Learning & Development
The skills and dedication of our employees drive our business
performance. Our comprehensive professional development
programs empower our people to build rewarding careers and
help us attract world-class talent. Our suite of professional
development programs ensures that our employees, regardless
of level, location, language or learning preferences, have access
to opportunities to develop and grow. Our investment in
employee development has contributed to more than
30 percent of our open roles being filled with internal employees.
Employee Engagement
Through our organizational health survey, we gain valuable
insight into the Medtronic employee experience and identify
areas where we can improve in four key priority areas: 1)
Employee Engagement, 2) Inclusion, 3) Innovation, and 4) Ethics.
In our most recent survey ending in May 2021, more than
83 percent of our employees responded, an increase in
participation over prior year (79 percent). Medtronic carefully
reviews and implements actions based on employee feedback in
order to partner and create an inclusive, innovative and
supportive environment.
Health & Safety
As a large, global employer, it is our responsibility to maintain a
safe workplace and support the well-being of our employees. As
we navigate the COVID-19 pandemic, we have placed a high
priority on employee health, providing accommodations and
resources to support our workforce through this challenging
time.
To help limit exposure to the coronavirus, we acted to ensure
employees in business-critical functions who cannot work from
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MEDTRONIC PLC 2021 Form 10-K
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home are protected, including those in research and
development, quality, manufacturing, distribution, and sales.
Personal protective equipment, increased sanitation, social
distancing guidance, and facility updates (one-way hallways,
cafeteria partitions and extra sinks) are provided to protect our
employees.
The Medtronic Employee Assistance Program and the
Medtronic Employee Emergency Assistance Fund have
historically supported employees and their families when faced
with difficult times by providing a variety of services such as
mental health and financial counseling and support at no cost.
Both programs have proven invaluable in navigating our
employees through unique challenges during the pandemic.
For more information on Human Capital Management at
Medtronic, please refer to our 2020 Integrated Report as well as
Medtronic’s 2020 Global Inclusion, Diversity and Equity Report
available on our company website.
OTHER FACTORS IMPACTING OUR OPERATIONS
COVID-19 Pandemic
The global COVID-19 pandemic (“COVID-19” or the
“pandemic”), together with the preventative and precautionary
measures taken by businesses, communities and governments,
has impacted, and may continue to impact significant aspects of
our Company and business, including demand for our products,
our operations, supply chains and distribution systems, and our
ability to research and develop and bring new products and
services to market. See “Item 1A. Risk Factors” in this Annual
Report on Form 10-K.
Research and Development
The markets in which we participate are subject to rapid
technological advances. Constant improvement of existing
products and introduction of new products is necessary to
maintain market leadership. Our research and development
(R&D) efforts are directed toward maintaining or achieving
technological leadership in each of the markets we serve to help
ensure that patients using our devices and therapies receive the
most advanced and effective treatment possible. We remain
committed to developing technological enhancements and new
indications for existing products, and less invasive and new
technologies for new and emerging markets to address unmet
patient needs. That commitment leads to our initiation and
participation in many clinical trials each fiscal year as the demand
for clinical and economic evidence remains high. Furthermore,
our development activities are intended to help reduce patient
care costs and the length of hospital stays in the future. We have
not engaged in significant customer or government-sponsored
research.
Our R&D activities include improving existing products and
therapies, expanding their indications and applications for use,
developing new therapies and procedures, and entering into
arrangements with third parties to fund the development of
certain technologies. We continue to focus on optimizing
innovation, improving our R&D productivity, driving growth in
emerging markets, generating clinical evidence, and assessing
our R&D programs based on their ability to address unmet
clinical needs, produce better patient outcomes, and create new
standards of care.
Intellectual Property
We rely on a combination of patents, trademarks, tradenames,
copyrights, trade secrets, and agreements (non-disclosure and
non-competition agreements) to protect our business and
proprietary technology. In addition, we have entered into
exclusive and non-exclusive licenses relating to a wide array of
third-party technologies. In the aggregate, these intellectual
property assets and licenses are of material importance to our
business; however, we believe that no single intellectual property
asset or license is material in relation to any segment of our
business or to our business as a whole.
We operate in an industry characterized by extensive patent
litigation. Patent litigation may result in significant damage
awards and injunctions that could prevent the manufacture and
sale of affected products or result in significant royalty payments
in order to continue selling the products. At any given time, we
are involved as both a plaintiff and a defendant in a number of
patent infringement actions, the outcomes of which may not be
known for prolonged periods of time. For additional information,
see Note 18 to the consolidated financial statements in “Item 8.
Financial Statements and Supplementary Data” in this Annual
Report on Form 10-K.
Sales and Distribution
We sell most of our medical devices and therapies through direct
sales representatives in the U.S. and a combination of direct
sales representatives and independent distributors in markets
outside the U.S. For certain portions of our business, we also sell
through distributors in the U.S. Additionally, a portion of the
Company’s revenue is generated from consignment inventory
maintained at hospitals. Our medical supplies products are used
primarily in hospitals, surgical centers, and alternate care
facilities, such as home care and long-term care facilities, and are
marketed to materials managers, GPOs and integrated delivery
networks (IDNs). We often negotiate with GPOs and IDNs, which
enter into supply contracts for the benefit of their member
facilities. Our four largest markets are the U.S., Western Europe,
China, and Japan. Emerging markets are an area of increasing
focus and opportunity, as we believe they remain under-
penetrated.
MEDTRONIC PLC 2021 Form 10-K 17
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Our marketing and sales strategy is focused on rapid, cost-
effective delivery of high-quality products to a diverse group of
customers worldwide. To achieve this objective, our marketing
and sales teams are organized around physician specialties. This
focus enables us to develop highly knowledgeable and dedicated
sales representatives who are able to foster strong relationships
with physicians and other customers and enhance our ability to
cross-sell complementary products.
We are not dependent on any single customer for more than
10 percent of our total net sales.
Competition, Industry, and Cost Containment
We compete in both the therapeutic and diagnostic medical
markets in more than 150 countries throughout the world.
These markets are characterized by rapid change resulting from
technological advances and scientific discoveries. Our product
lines face a mix of competitors ranging from large manufacturers
with multiple business lines to small manufacturers offering a
limited selection of products. In addition, we face competition
from providers of other medical therapies, such as
pharmaceutical companies.
Major shifts in industry market share have occurred in
connection with product problems, physician advisories, safety
alerts, results of clinical trials to support superiority claims, and
publications about our products, reflecting the importance of
product quality, product efficacy and quality systems in the
medical device industry. In the current environment of managed
care, economically motivated customers, consolidation among
healthcare providers, increased competition, declining
reimbursement rates, and national tender pricing, competitively
priced product offerings are essential to our business. In order to
continue to compete effectively, we must continue to create or
acquire advanced technology, incorporate this technology into
proprietary products, obtain regulatory approvals in a timely
manner, maintain high-quality manufacturing processes, and
successfully market these products.
Government and private sector initiatives to limit the growth of
healthcare costs, including price regulation, competitive pricing,
bidding and tender mechanics, coverage and payment policies,
comparative effectiveness of therapies, technology assessments
and managed-care arrangements, are continuing in many
countries where we do business, including the U.S. These
initiatives put increased emphasis on the delivery of more cost-
effective medical devices and therapies. Government programs,
including Medicare and Medicaid, private healthcare insurance and
managed-care plans have attempted to control costs by limiting
the amount of reimbursement they will pay for particular
procedures or treatments, tying reimbursement to outcomes,
shifting to population health management, and other
mechanisms. Hospitals, which purchase our technology, are also
seeking to reduce costs through a variety of mechanisms,
including, for example, centralized purchasing, and in some cases,
limitingthenumberofvendorsthatmayparticipateinthe
purchasing program. Hospitals are also aligning interests with
physicians through employment and other arrangements, such as
gainsharing, where a hospital agrees with physicians to share any
realized cost savings resulting from changes in practice patterns
such as device standardization. This has created an increased level
of price sensitivity among customers for our products.
Production and Availability of Raw Materials
We manufacture products at manufacturing facilities located in
various countries throughout the world. We purchase many of
the components and raw materials used in manufacturing our
products from numerous suppliers in various countries. Certain
components and raw materials are available only from a sole
supplier. We work closely with our suppliers to help ensure
continuity of supply while maintaining high quality and reliability.
Generally, we have been able to obtain adequate supplies of such
raw materials and components. However, due to the U.S. FDA’s
manufacturing requirements, we may not be able to quickly
establish additional or replacement sources for certain
components or materials if we experience a sudden or
unexpected reduction or interruption in supply and are unable to
develop alternative sources.
For additional information related to our manufacturing facilities
refer to “Item 2. Properties” in this Annual Report on Form 10-K.
Government Regulation
Our operations and products are subject to extensive regulation
by numerous government agencies, including the U.S. FDA,
European regulatory authorities such as the Medicines and
Healthcare Products Regulatory Agency in the United Kingdom
Republic of Ireland and the Federal Institute for Drugs and
Medical Devices in Germany, the China National Medical Product
Administration (NMPA), and other government agencies inside
and outside the U.S. To varying degrees, each of these agencies
requires us to comply with laws and regulations governing the
development, testing, manufacturing, labeling, marketing,
distribution and post-marketing surveillance of our products.
Our business is also affected by patient and data privacy laws and
government payer cost containment initiatives, as well as
environmental health and safety laws and regulations.
Product Approval and Monitoring
Many countries where we sell medical devices subject such
medical devices and technologies to their own approval and
other regulatory requirements regarding performance, safety,
and quality of our products. Authorization to commercially
distribute a new medical device in the U.S. is generally obtained in
one of two ways. The first, known as pre-market notification or
the 510(k) process, requires us to demonstrate that our medical
device is substantially equivalent to a legally marketed medical
device. The second, more rigorous process, known as
pre-market approval, requires us to independently demonstrate
that a medical device is safe and effective for its intended use.
This process is generally much more time-consuming and
expensive than the 510(k) process.
In the E.U., a single regulatory approval process exists, and
conformity with the legal requirements is represented by the CE
Mark. To obtain a CE Mark, defined products must meet
minimum standards of performance, safety, and quality (i.e., the
essential requirements), and then, according to their
18
MEDTRONIC PLC 2021 Form 10-K
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Item 1 Business
classification, comply with one or more of a selection of
conformity assessment routes. The competent authorities of
the E.U. countries separately regulate the clinical research for
medical devices and the market surveillance of products once
they are placed on the market. A new Medical Device Regulation
was published by the E.U. in 2017 which imposes significant
additional premarket and postmarket requirements (EU MDR).
The regulation provided an implementation period and became
effective on May 26, 2021. Medical devices marketed in the E.U.
will require certification according to these new requirements,
except that devices with valid CE certificates, issued pursuant to
the Medical Device Directives before May 2020, can be placed on
the market until May 2024.
The global regulatory environment is increasingly stringent and
unpredictable. Several countries that did not have regulatory
requirements for medical devices have established such
requirements in recent years, and other countries have
expanded, or plan to expand, their existing regulations. While
harmonization of global regulations has been pursued,
requirements continue to differ significantly among countries.
We expect this global regulatory environment will continue to
evolve, which could impact the cost, the time needed to
approve, and ultimately, our ability to maintain existing approvals
or obtain future approvals for our products. Regulations of the
U.S. FDA and other regulatory agencies in and outside the U.S.
impose extensive compliance and monitoring obligations on our
business. These agencies review our design and manufacturing
practices, labeling, record keeping, and manufacturers’ required
reports of adverse experiences and other information to identify
potential problems with marketed medical devices. We are also
subject to periodic inspections for compliance with applicable
quality system regulations, which govern the methods used in,
and the facilities and controls used for, the design, manufacture,
packaging, and servicing of finished medical devices intended for
human use. In addition, the U.S. FDA and other regulatory bodies,
both in and outside the U.S. (including the Federal Trade
Commission, the Office of the Inspector General of the
Department of Health and Human Services, the U.S.
Department of Justice, and various state Attorneys General),
monitor the promotion and advertising of our products. Any
adverse regulatory action, depending on its magnitude, may limit
our ability to effectively market and sell our products, limit our
ability to obtain future premarket approvals or result in a
substantial modification to our business practices and
operations. For additional information, see “Item 1A. Risk
Factors” We are subject to extensive and complex laws and
governmental regulations and any adverse regulatory action may
materially adversely affect our financial condition and business
operations.
In April 2015, we entered into a consent decree with the U.S. FDA
relating to our Pain Therapies division’s SynchroMed II drug
infusion system and its associated quality system. The consent
decree requires us to complete certain corrections and
enhancements to the SynchroMed pump and the
Neuromodulation quality system. The consent decree’s
limitations on our ability to manufacture and distribute the
SynchroMed drug infusion system were lifted by the U.S. FDA in
September 2017. The final required third-party expert audit is
complete, and following a successful U.S. FDA inspection, and in
coordination with the U.S. FDA, Medtronic can move to have the
consent decree vacated.
Trade Regulations
The movement of products, services, and investment across
borders subjects us to extensive trade regulations. A variety of
laws and regulations in the countries in which we transact
business apply to the sale, shipment and provision of goods,
services and technology across borders. These laws and
regulations govern, among other things, our import, export and
other business activities. We are also subject to the risk that
these laws and regulations could change in a way that would
expose us to additional costs, penalties or liabilities. Some
governments also impose economic sanctions against certain
countries, persons or entities. In addition to our need to comply
with such regulations in connection with our direct activities, we
also sell and provide goods, technology and services to agents,
representatives and distributors who may export such items to
customers and end-users. If we, or the third parties through
which we do business, are not in compliance with applicable
import, export control or economic sanctions laws and
regulations, we may be subject to civil or criminal enforcement
action, and varying degrees of liability. Such actions may disrupt
or delay sales of our products or services or result in restrictions
on our distribution and sales of products or services that may
materially impact our business.
Anti-Boycott Laws
Under U.S. laws and regulations, U.S. companies and their
subsidiaries and affiliates outside the U.S. are prohibited from
participating or agreeing to participate in unsanctioned foreign
boycotts in connection with certain business activities, including
the sale, purchase, transfer, shipping or financing of goods or
services within the U.S. or between the U.S. and countries
outside of the U.S. If we, or certain third parties through which we
sell or provide goods or services, violate anti-boycott laws and
regulations, we may be subject to civil or criminal enforcement
action and varying degrees of liability.
Data Privacy and Security Laws and Regulations
As a business with a significant global footprint, compliance with
evolving regulations and standards in data privacy and
cybersecurity has resulted, and may continue to result, in
increased costs, new compliance challenges, and the threat of
increased regulatory enforcement activity. Our business relies
on the secure electronic transmission, storage and hosting of
sensitive information, including personal information, protected
health information, financial information, intellectual property
and other sensitive information related to our customers and
workforce.
For example, in the U.S., the collection, maintenance, protection,
use, transmission, disclosure and disposal of certain personal
information and the security of medical devices are regulated at
the U.S. federal and state, international and industry levels.
U.S. federal and state laws protect the confidentiality of certain
patient health information, including patient medical records, and
restrict the use and disclosure of patient health information by
MEDTRONIC PLC 2021 Form 10-K 19
PART I
Item 1 Business
healthcare providers. Privacy and Security Rules under the
Health Insurance Portability and Accountability Act of 1996
(HIPAA), as amended, and the Health Information Technology
for Economic and Clinical Health Act of 2009 (HITECH), govern
the use, disclosure, and security of protected health information
by “Covered Entities,” (which are healthcare providers that
submit electronic claims, health plans, and healthcare
clearinghouses) and by their “Business Associates” (which is
anyone that performs a service on behalf of a Covered Entity
involving the use or disclosure of protected health information
and is not a member of the Covered Entity’s workforce). Rules
under HIPAA and HITECH include specific security standards and
breach notification requirements. The U.S. Department of
Health and Human Services (HHS) (through the Office of Civil
Rights) has direct enforcement authority against Covered
Entities and Business Associates with respect to both the
Security and Privacy Rules, including civil and criminal liability.
Except for certain of its operations in its Diabetes and care
management services businesses, Medtronic is generally not a
Covered Entity. Medtronic also operates as a Business Associate
to Covered Entities in several instances. There are comparable
state laws governing the use and protection of personal health
information by healthcare providers, and Medtronic may be
subject to these laws in certain of its businesses.
In addition to the regulation of personal health information, a
number of states have also adopted laws and regulations that
may affect our privacy and data security practices for other kinds
of personally identifiable information, such as state laws that
govern the use, disclosure and protection of sensitive personal
information, such as social security numbers, or that are
designed to protect credit card account data. State consumer
protection laws may also establish privacy and security standards
for use and management of personally identifiable information,
including information related to consumers.
Outside the U.S., we are impacted by the privacy and data
security requirements at the international, federal and regional
level, and on an industry specific basis. We serve customers in
more than 150 countries. Legal requirements in these countries
relating to the collection, storage, handling and transfer of
personal data and potentially intellectual property continue to
evolve with increasingly strict enforcement regimes. More
privacy and security laws and regulations are being adopted, and
more are being enforced, with potential for significant financial
penalties. In the E.U., stringent data protection and privacy rules
which substantially impact the use of patient data across the
healthcare industry became effective in May 2018. The E.U.
General Data Protection Regulation (GDPR) applies uniformly
across the E.U. and includes, among other things, a requirement
for prompt notice of data breaches to data subjects and
supervisory authorities in certain circumstances and significant
fines for non-compliance. The GDPR also requires companies
based outside of the E.U. but processing personal data of
individuals residing in the E.U. to comply with E.U. privacy and
data protection rules.
Because the laws and regulations continue to expand, differ from
jurisdiction to jurisdiction, and are subject to evolving (and at
times inconsistent) governmental interpretation, compliance
with these laws and regulations may require significant additional
cost expenditures or changes in products or business that
increase competition or reduce revenue. Noncompliance could
result in the imposition of fines, penalties, or orders to stop
noncompliant activities.
Regulations Governing Reimbursement
The delivery of our devices is subject to regulation by HHS and
comparable state and non-U.S. agencies responsible for
reimbursement and regulation of healthcare items and services.
U.S. laws and regulations are imposed primarily in connection
with federally funded healthcare programs, such as the Medicare
and Medicaid programs, as well as the government’s interest in
regulating the quality and cost of healthcare. Other
governments also impose regulations in connection with their
healthcare reimbursement programs and the delivery of
healthcare items and services.
U.S. federal healthcare laws apply when we or customers submit
claims for items or services that are reimbursed under federally-
funded healthcare programs, including laws related to kickbacks,
false claims, self-referrals and healthcare fraud. There are often
similar state false claims, anti-kickback, and anti-self-referral and
insurance laws that apply to state Medicaid and other healthcare
programs and private third-party payers. In some circumstances,
insurance companies attempt to bring a private cause of action
against a manufacturer for a pattern of causing false claims. In
addition, as a manufacturer of U.S. FDA-approved devices
reimbursable by federal healthcare programs, we are subject to the
Physician Payments Sunshine Act, which requires us to annually
report certain payments and other transfers of value we make to
U.S.-licensed physicians or U.S. teaching hospitals. Any failure to
comply with these laws and regulations could subject us or our
officers and employees to criminal and civil financial penalties.
Implementation of legislative or regulatory reforms to
reimbursement systems, or adverse decisions relating to our
products by administrators of these systems in coverage or
reimbursement, could significantly reduce reimbursement or
result in the denial of coverage, which could have an impact on
the acceptance of and demand for our products and the prices
that our customers are willing to pay for them.
Environmental Health and Safety Laws
We are also subject to various environmental health and safety
laws and regulations both within and outside the U.S. Like other
companies in our industry, our manufacturing and other
operations involve the use and transportation of substances
regulated under environmental health and safety laws including
those related to the transportation of hazardous materials.
Available Information
We maintain a website at www.medtronic.com. Our Annual
Reports on Form 10-K, Quarterly Reports on Form 10-Q,
Current Reports on Form 8-K, and amendments to those
reports filed or furnished pursuant to Section 13(a) or 15(d) of
the Securities Exchange Act of 1934, as amended (Exchange
Act) are made available under the “About Medtronic - Investors”
caption and “Financial Information - SEC Filings” subcaption of
our website as soon as reasonably practicable after we
electronically file them with, or furnish them to, the Securities
and Exchange Commission (SEC).
20
MEDTRONIC PLC 2021 Form 10-K
PART I
Item 1A Risk Factors
Information relating to our corporate governance, including our
Principles of Corporate Governance, Code of Conduct (including
our Code of Ethics for Senior Financial Officers and any related
amendments or waivers), Code of Business Conduct and Ethics
for Members of the Board of Directors, and information
concerning our executive officers, directors and Board
committees (including committee charters) is available through
our website at www.medtronic.com under the “About
Medtronic - Corporate Governance” caption. Information
relating to transactions in Medtronic securities by directors and
officers is available through our website at www.medtronic.com
under the “About Medtronic - Investors” caption and the
“Financial Information - SEC Filings” subcaption.
Our website and the information contained on or connected to
our website are not incorporated by reference into this Form
10-K.
The SEC maintains a website that contains reports, proxy and
information statements, and other information regarding
issuers, including the Company, that file electronically with the
SEC. The public may obtain any documents that we file with the
SEC at http://www.sec.gov. We file annual reports, quarterly
reports, proxy statements, and other documents with the SEC
under the Exchange Act.
Item 1A. Risk Factors
Investing in our securities involves a variety of risks and
uncertainties, known and unknown, including, among others,
those discussed below. Each of the following risks should be
carefully considered, together with all the other information
included in this Annual Report on Form 10-K, including our
consolidated financial statements and the related notes and in
our other filings with the SEC. Furthermore, additional risks and
uncertainty not presently known to us or that we currently
believe to be immaterial may also adversely affect our business.
Our business, results of operations, financial condition, and cash
flow and prospects could be materially and adversely affected by
any of these risks or uncertainties.
Business and Operational Risks
We operate in a highly competitive industry
and we may be unable to compete effectively.
We compete in both the therapeutic and diagnostic medical
markets in more than 150 countries throughout the world.
These markets are characterized by rapid change resulting from
technological advances and scientific discoveries. In the product
lines in which we compete, we face a range of competitors from
large companies with multiple business lines to small, specialized
manufacturers that offer a limited selection of niche products.
Development by other companies of new or improved products,
processes, technologies, or the introduction of reprocessed
products or generic versions when our proprietary products lose
their patent protection may make our existing or planned
products less competitive. In addition, we face competition from
providers of alternative medical therapies, such as
pharmaceutical companies.
We believe our ability to compete depends upon many factors
both within and beyond our control, including:
product performance and reliability,
product technology and innovation,
product quality and safety,
breadth of product lines,
product support services,
customer support,
cost-effectiveness and price,
reimbursement approval from healthcare insurance providers,
and
changes to the regulatory environment.
Competition may increase as additional companies enter our
markets or modify their existing products to compete directly
with ours. In addition, academic institutions, governmental
agencies and other public and private research organizations
also may conduct research, seek patent protection and establish
collaborative arrangements for discovery, research, clinical
development and marketing of products similar to ours. These
companies and institutions compete with us in recruiting and
retaining qualified scientific and management personnel, as well
as in acquiring necessary product technologies. From time to
time we have lost, and may in the future lose, market share in
connection with product problems, physician advisories, safety
alerts and publications about our products, which highlights the
importance of product quality, product efficacy and quality
systems to our business. In the current environment of managed
care, consolidation among healthcare providers, increased
competition, declining reimbursement rates, and national tender
pricing, as recently experienced in China, competitively priced
product offerings are essential to our success. Further, our
continued growth and success depend on our ability to develop,
acquire and market new and differentiated products,
technologies and intellectual property, and as a result we also
face competition for marketing, distribution, and collaborative
development agreements, establishing relationships with
academic and research institutions and licenses to intellectual
property. In order to continue to compete effectively, we must
continue to create, invest in or acquire advanced technology,
incorporate this technology into our proprietary products, obtain
regulatory approvals in a timely manner, and manufacture and
successfully market our products. Given these factors, we
cannot guarantee that we will be able to compete effectively or
continue our level of success.
MEDTRONIC PLC 2021 Form 10-K 21
PART I
Item 1A Risk Factors
The ongoing global COVID-19 pandemic has
had, and may continue to have, an adverse
effect on certain aspects of our business,
results of operations, financial condition and
cash flows. The nature and extent of future
impacts are highly uncertain and
unpredictable.
Our global operations and interactions with healthcare systems,
providers and patients around the world expose us to risks
associated with public health crises, including epidemics and
pandemics such as COVID-19. In particular, the continuing
preventative and precautionary measures that we and other
businesses, communities, and governments have taken to
mitigate the spread of the disease has led to restrictions on,
disruptions in, and other related impacts on business and
personal activities, including reduced customer demand for
certain of our products and has resulted in many of our
employees working remotely. We expect medical procedure
rates to continue to vary by therapy and country, and could be
impacted by regional COVID-19 case volumes, hospital and
clinical occupancy and staffing levels, patient’s willingness to
schedule deferrable procedures, travel restrictions,
transportation limitations, quarantine restrictions, vaccine
immunization rates, and new COVID-19 variants. While
COVID-19 case volumes appear to be decreasing in the U.S and
certain other countries as a result of higher vaccination rates, the
global COVID-19 outlook remains uncertain as vaccination rates
remain low in much of the world.
Together with the preventative and precautionary measures
being taken, as well as the corresponding need to adapt to new
and improved methods of conducting business, such as
increased remote monitoring, COVID-19 is having, and may
continue to have, an adverse impact on certain aspects of our
Company and business, including the demand for and supply of
certain of our products, operations, supply chains and
distribution systems, impacts or delays to product development
milestones, clinical trials, or regulatory clearances and approval
timing, and our ability to generate cash flow, and may have an
adverse impact on our ability to access capital. Some of our
products are more sensitive to reductions in deferrable and
emergent medical procedures, and, as hospital systems
prioritize treatment of COVID-19 patients and otherwise comply
with government guidelines, certain medical procedures have
been and may continue to be suspended or postponed. The
Company has certain product lines that are in higher demand as
a result of COVID-19 such as ventilators, pulse oximetry,
capnography, advanced parameter monitoring, and
extracorporeal life support products. It is not possible to predict
the timing of deferrable medical procedures and, to the extent
individuals and hospital systems de-prioritize, delay or cancel
these procedures, or if unemployment or loss of insurance
coverage adversely impacts an individual’s ability to pay for our
products and services, our business, results of operations,
financial condition, and cash flows could continue to be
negatively affected. Further, the COVID-19 pandemic has
strained hospital systems around the world, resulting in adverse
financial impacts to those systems that could result in reduced
future expenditures for certain capital equipment and other
products and services we provide, as well as potential disruption
of product launches of our recently approved products.
A number of our global suppliers, vendors, and distributors have
been adversely affected by the COVID-19 pandemic, including
employee absenteeism. These impacts could impair our ability to
move our products through distribution channels to end
customers, and any such delay or shortage in the supply of
components or materials may result in our inability to satisfy
consumer demand for certain of our products in a timely manner
or at all, which could harm our reputation, future sales and
profitability.
COVID-19 has impacted and may further impact the global
economy and capital markets, including by negatively impacting
demand for a number of our products, access to capital markets
(including the commercial paper market), foreign currency
exchange rates, and interest rates, each of which may adversely
impact our business and liquidity. We could experience loss of
sales and profits due to delayed payments or insolvency of
healthcare professionals, hospitals and other customers,
suppliers and vendors facing liquidity issues. As a result, we may
be compelled to take additional measures to preserve our cash
flow.
COVID-19 could adversely impact our ability to retain key
employees and the continued service and availability of skilled
personnel necessary to run our complex productions and
operations, including our executive officers and other key
members of our management team.
While the impact of COVID-19 has had, and may continue to
have, an adverse effect on our business, results of operations,
financial condition and cash flows, the nature and extent of such
impact is highly uncertain and unpredictable, as we cannot
predict with confidence the duration of the pandemic.
Reduction or interruption in supply or other
manufacturing difficulties may adversely
affect our manufacturing operations and
related product sales.
The manufacture of our products requires the timely delivery of
a sufficient amount of quality components and materials and is
highly exacting and complex, due in part to strict regulatory
requirements. We manufacture the majority of our products and
procure important third-party services, such as sterilization
services, at numerous facilities worldwide. We purchase many of
the components, raw materials and services needed to
manufacture these products from numerous suppliers in various
countries. We seek to maintain continuity of supply by use of
multiple options for sourcing where possible. We have generally
been able to obtain adequate supplies of such raw materials,
components and services. However, for reasons of quality
assurance, cost effectiveness, or availability, certain
components, raw materials and services needed to manufacture
our products are obtained from a sole supplier. Although we
work closely with our suppliers to try to ensure continuity of
supply while maintaining high quality and reliability, the supply of
these components, raw materials and services may be
22
MEDTRONIC PLC 2021 Form 10-K
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Item 1A Risk Factors
interrupted or insufficient. In addition, due to the stringent
regulations and requirements of regulatory agencies, including
the U.S. FDA, regarding the manufacture of our products, we
may not be able to quickly establish additional or replacement
sources. Additionally, many regulatory agencies are imposing
regulatory requirements on safe use of chemicals and their
potential impact on health and the environment which also may
impact supply constraints. Furthermore, the prices of
commodities and other materials used in our products, which are
often volatile and outside of our control, could adversely impact
our supply. We use resins, other petroleum-based materials and
pulp as raw materials in some of our products, and the prices of
oil and gas also significantly affect our costs for freight and
utilities. A reduction or interruption in supply, and an inability to
develop alternative sources for such supply, could adversely
affect our ability to manufacture our products in a timely or cost-
effective manner and could result in lost sales.
Other disruptions in the manufacturing process or product sales
and fulfillment systems for any reason, including equipment
malfunction, failure to follow specific protocols and procedures,
supplier facility shut-downs, defective raw materials, natural
disasters such as hurricanes, tornadoes or wildfires, property
damage or facility closures from riots or public protests, and
other environmental factors and the impact of epidemics or
pandemics, such as the COVID-19 pandemic, and actions by
businesses, communities and governments in response, could
lead to launch delays, product shortage, unanticipated costs, lost
revenues and damage to our reputation. For example, in the past
we have experienced a global information technology systems
interruption that affected our customer ordering, distribution,
and manufacturing processes, and we have been adversely
impacted by, and may continue to be adversely impacted by, the
global COVID-19 pandemic and the responses of governments
and of our partners, including suppliers, manufacturers,
distributors and other businesses. Furthermore, any failure to
identify and address manufacturing problems prior to the release
of products to our customers could result in quality or safety
issues.
In addition, many of our products require sterilization before sale
and several of our key products are manufactured or sterilized at
a particular facility, with limited alternate facilities. If an event
occurs that results in damage to or closure of one or more of
such facilities, such as the damage caused by Hurricane Maria in
Puerto Rico in September 2017 or Illinois Environmental
Protection Agency’s decision to close a supplier’s sterilization
facility in February 2019, we may be unable to manufacture or
sterilize the relevant products to the required quality
specifications or at all. Because of the time required to approve
and license a manufacturing or sterilization facility, a third-party
may not be available on a timely basis to replace production
capacity in the event manufacturing or sterilization capacity is
lost.
Our research and development efforts rely
upon investments and investment
collaborations, and we cannot guarantee that
any previous or future investments or
investment collaborations will be successful.
Our mission is to provide a broad range of therapies to restore
patients to fuller, healthier lives, which requires a wide variety of
technologies, products and capabilities. The rapid pace of
technological development in the medical industry and the
specialized expertise required in different areas of medicine
make it difficult for one company alone to develop a broad
portfolio of technological solutions. In addition to internally
generated growth through our research and development
efforts, historically we have relied, and expect to continue to rely,
upon investments and investment collaborations to provide us
access to new technologies both in areas served by our existing
businesses as well as in new areas.
We expect to make future investments where we believe that we
can stimulate the development or acquisition of new
technologies and products to further our strategic objectives
and strengthen our existing businesses. Investments and
investment collaborations in and with medical technology
companies are inherently risky, and we cannot guarantee that
any of our previous or future investments or investment
collaborations will be successful or will not materially adversely
affect our business, results of operations, financial condition and
cash flows.
The continuing development of many of our
products depends upon us maintaining strong
relationships with healthcare professionals.
If we fail to maintain our working relationships with healthcare
professionals, many of our products may not be developed and
marketed in line with the needs and expectations of the
professionals who use and support our products, which could
cause a decline in our earnings and profitability. The research,
development, marketing and sales of many of our new and
improved products depends on our maintaining working
relationships with healthcare professionals. We rely on these
professionals to provide us with considerable knowledge and
experience regarding the development, marketing and sale of
our products. Physicians assist us as researchers, marketing and
product consultants, inventors and public speakers. In addition,
as a result of the COVID-19 pandemic, our access to these
professionals has been limited at times, and travel restrictions,
shutdowns and similar measures have impacted our ability to
maintain these relationships, thereby affecting our ability to
develop, market and sell new and improved products. If we are
unable to maintain strong relationships with these professionals,
the development and marketing of our products could suffer,
which could have a material adverse effect on our business,
results of operations, financial condition, and cash flows.
MEDTRONIC PLC 2021 Form 10-K 23
PART I
Item 1A Risk Factors
Our substantial leverage and debt service
obligations could adversely affect our
business.
At April 30, 2021, we had approximately $26.4 billion of debt, of
which all is noncurrent except $11.0 million. We may also incur
additional indebtedness in the future. Our substantial
indebtedness could have adverse consequences, including:
making it more difficult for us to satisfy our financial
obligations,
increasing our vulnerability to adverse economic, regulatory
and industry conditions, and placing us at a disadvantage
compared to our competitors that are less leveraged,
limiting our ability to compete and our flexibility in planning for,
or reacting to, changes in our business and the industry in
which we operate,
limiting our ability to borrow additional funds for working
capital, capital expenditures, acquisitions and general
corporate or other purposes, and
exposing us to greater interest rate risk since the interest rate
on floating rate borrowings is variable.
Our debt service obligations require us to use a portion of our
operating cash flow to pay interest and principal on indebtedness
instead of for other corporate purposes, including funding future
expansion of our business, acquisitions, and ongoing capital
expenditures, which could impede our growth. If our operating
cash flow and capital resources are insufficient to service our
debt obligations, we may be forced to sell assets, seek additional
equity or debt financing or restructure our debt, which could
harm our long-term business prospects. Our failure to comply
with the terms of our revolving credit facility and other
indebtedness could result in an event of default which, if not
cured or waived, could result in the acceleration of all of our debt.
Failure to integrate acquired businesses into
our operations successfully, as well as
liabilities or claims relating to such acquired
businesses, could adversely affect our
business.
As part of our strategy to develop and identify new products and
technologies, we have made several significant acquisitions in
recent years, and may make additional acquisitions in the future.
Our integration of the operations of acquired businesses
requires significant efforts, including the coordination of
information technologies, research and development, sales and
marketing, operations, manufacturing, and finance. These
efforts result in additional expenses and involve significant
amounts of management’s time that cannot then be dedicated
to other projects. Our failure to manage and coordinate the
growth of acquired companies successfully could also have an
adverse impact on our business. Further, acquired businesses
may have liabilities, or be subject to claims, litigation or
investigations that we did not anticipate or which exceed our
estimates at the time of the acquisition. In addition, we cannot be
certain that the businesses we acquire will become profitable or
remain so. Factors that will affect the success of our acquisitions
include:
the presence or absence of adequate internal controls and/or
significant fraud in the financial systems of acquired
companies,
our ability or inability to integrate information technology
systems of acquired companies in a secure and reliable
manner,
liabilities, claims, litigation, investigations, or other adverse
developments relating to acquired businesses or the business
practices of acquired companies, including investigations by
governmental entities, potential FCPA or product liability
claims or other unanticipated liabilities,
any decrease in customer loyalty and product orders caused
by dissatisfaction with the combined companies’ product lines
and sales and marketing practices, including price increases,
our ability to retain key employees, and
the ability to achieve synergies among acquired companies,
such as increasing sales of the integrated company’s
products, achieving cost savings, and effectively combining
technologies to develop new products.
We also could experience negative effects on our business,
results of operations, financial condition, and cash flows from
acquisition-related charges, amortization of intangible assets
and asset impairment charges. These effects, individually or in
the aggregate, could cause a deterioration of our credit rating
and result in increased borrowing costs and interest expense.
Legal and Regulatory Risks
Climate change, or legal, regulatory or market
measures to address climate change may
materially adversely affect our financial
condition and business operations.
Climate change resulting from increased concentrations of
carbon dioxide and other greenhouse gases in the atmosphere
could present risks to our future operations from natural
disasters and extreme weather conditions, such as hurricanes,
tornadoes, earthquakes, wildfires or flooding. Such extreme
weather conditions could pose physical risks to our facilities and
disrupt operation of our supply chain and may impact operational
costs. The impacts of climate change on global water resources
may result in water scarcity, which could in the future impact our
ability to access sufficient quantities of water in certain locations
and result in increased costs. Concern over climate change could
result in new legal or regulatory requirements designed to
mitigate the effects of climate change on the environment. If
such laws or regulations are more stringent than current legal or
regulatory requirements, we may experience increased
compliance burdens and costs to meet the regulatory
obligations and may adversely affect raw material sourcing,
manufacturing operations and the distribution of our products.
24
MEDTRONIC PLC 2021 Form 10-K
PART I
Item 1A Risk Factors
We are subject to extensive and complex laws
and governmental regulations and any
adverse regulatory action may materially
adversely affect our financial condition and
business operations.
Our medical devices and technologies, as well as our business
activities, are subject to a complex set of regulations and
rigorous enforcement, including by the U.S. FDA, U.S.
Department of Justice, Health and Human Services-Office of
the Inspector General, and numerous other federal, state, and
non-U.S. governmental authorities. To varying degrees, each of
these agencies requires us to comply with laws and regulations
governing the development, testing, manufacturing, labeling,
marketing and distribution of our products. 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
clinical data from existing or future clinical trials may adversely
impact our ability to obtain product approvals, our position in,
and share of, the markets in which we participate, and our
business, results of operations, financial condition, and cash
flows. We cannot guarantee that we will be able to obtain or
maintain marketing clearance for our new products or
enhancements or modifications to existing products, and the
failure to maintain approvals or obtain approval or clearance
could have a material adverse effect on our business, results of
operations, financial condition and cash flows. Even if we are able
to obtain approval or clearance, it may:
take a significant amount of time,
require the expenditure of substantial resources,
involve stringent clinical and pre-clinical testing, as well as
increased post-market surveillance,
involve modifications, repairs or replacements of our
products, and
limit the proposed uses of our products.
Both before and after a product is commercially released, we
have ongoing responsibilities under the U.S. FDA and other
applicable non-U.S. government agency regulations. For
instance, many of our facilities and procedures and those of our
suppliers are also subject to periodic inspections by the U.S. FDA
to determine compliance with applicable regulations. The results
of these inspections can include inspectional observations on
the U.S. FDA’s Form-483, warning letters, or other forms of
enforcement. If the U.S. FDA were to conclude that we are not in
compliance with applicable laws or regulations, or that any of our
medical products are ineffective or pose an unreasonable health
risk, the U.S. FDA could ban such medical products, detain or
seize adulterated or misbranded medical products, order a recall,
repair, replacement, or refund of such products, refuse to grant
pending pre-market approval applications or require certificates
of non-U.S governments for exports, and/or require us to notify
health professionals and others that the devices present
unreasonable risks of substantial harm to the public health. The
U.S. FDA and other non-U.S. government agencies may also
assess civil or criminal penalties against us, our officers or
employees and impose operating restrictions on a company-
wide basis. The U.S. FDA may also recommend prosecution to
the U.S. Department of Justice. Any adverse regulatory action,
depending on its magnitude, may restrict us from effectively
marketing and selling our products and limit our ability to obtain
future pre-market clearances or approvals, and could result in a
substantial modification to our business practices and
operations. Furthermore, we occasionally receive subpoenas or
other requests for information from state and federal
governmental agencies, and while these investigations typically
relate primarily to financial arrangements with healthcare
providers, regulatory compliance and product promotional
practices, we cannot predict the timing, outcome or impact of
any such investigations. Any adverse outcome in one or more of
these investigations could include the commencement of civil
and/or criminal proceedings, substantial fines, penalties, and/or
administrative remedies, including exclusion from government
reimbursement programs and/or entry into Corporate Integrity
Agreements (CIAs) with governmental agencies. In addition,
resolution of any of these matters could involve the imposition
of additional, costly compliance obligations. These potential
consequences, as well as any adverse outcome from
government investigations, could have a material adverse effect
on our business, results of operations, financial condition, and
cash flows.
In addition, the U.S. FDA has taken the position that device
manufacturers are prohibited from promoting their products
other than for the uses and indications set forth in the approved
product labeling, and any failure to comply could subject us to
significant civil or criminal exposure, administrative obligations
and costs, and/or other potential penalties from, and/or
agreements with, the federal government.
Governmental regulations outside the U.S. have, and may
continue to, become increasingly stringent and common. In the
European Union, for example, a new Medical Device Regulation
which became effective in May 2021, includes significant
additional premarket and post-market requirements. Penalties
for regulatory non-compliance could be severe, including fines
and revocation or suspension of a company’s business license,
mandatory price reductions and criminal sanctions. Future laws
and regulations may have a material adverse effect on us.
Our failure to comply with laws and
regulations relating to reimbursement of
healthcare goods and services may subject us
to penalties and adversely impact our
reputation, business, results of operations,
financial condition and cash flows.
Our devices, products and therapies are purchased principally by
hospitals or physicians that typically bill various third-party
payers, such as governmental healthcare programs (e.g.,
Medicare, Medicaid and comparable non-U.S. programs), private
insurance plans and managed care plans, for the healthcare
services provided to their patients. The ability of our customers
to obtain appropriate reimbursement for products and services
from third-party payers is critical because it affects which
MEDTRONIC PLC 2021 Form 10-K 25
PART I
Item 1A Risk Factors
products customers purchase and the prices they are willing to
pay. As a result, our devices, products and therapies are subject
to regulation regarding quality and cost by HHS, including the
Centers for Medicare & Medicaid Services (CMS), as well as
comparable state and non-U.S. agencies responsible for
reimbursement and regulation of health are goods and services,
including laws and regulations related to kickbacks, false claims,
self-referrals and healthcare fraud. Many states have similar laws
that apply to reimbursement by state Medicaid and other funded
programs as well as in some cases to all payers. In certain
circumstances, insurance companies attempt to bring a private
cause of action against a manufacturer for causing false claims.
In addition, as a manufacturer of U.S. FDA-approved devices
reimbursable by federal healthcare programs, we are subject to
the Physician Payments Sunshine Act, which requires us to
annually report certain payments and other transfers of value we
make to U.S.-licensed physicians or U.S. teaching hospitals. Any
failure to comply with these laws and regulations could subject us
or our officers and employees to criminal and civil financial
penalties.
We are also subject to risks relating to changes in government
and private medical reimbursement programs and policies, and
changes in legal regulatory requirements in the U.S. and around
the world. Implementation of further legislative or administrative
reforms to these reimbursement systems, or adverse decisions
relating to coverage of or reimbursement for our products by
administrators of these systems, could have an impact on the
acceptance of and demand for our products and the prices that
our customers are willing to pay for them.
We are substantially dependent on patent and
other proprietary rights and failing to protect
such rights or to be successful in litigation
related to our rights or the rights of others
may result in our payment of significant
monetary damages and/or royalty payments,
negatively impacting our ability to sell current
or future products.
We are substantially dependent on patent and other proprietary
rights and rely on a combination of patents, trademarks,
tradenames, copyrights, trade secrets, and agreements (such as
employee, non-disclosure and non-competition agreements) to
protect our business and proprietary intellectual property. We
also operate in an industry characterized by extensive patent
litigation. Patent litigation can result in significant damage awards
and injunctions that could prevent our manufacture and sale of
affected products or require us to pay significant royalties in
order to continue to manufacture or sell affected products. At
any given time, we are generally involved as both a plaintiff and a
defendant in a number of patent infringement actions, the
outcomes of which may not be known for prolonged periods of
time. While it is not possible to predict the outcome of patent
litigation, it is possible that the results of such litigation could
require us to pay significant monetary damages and/or royalty
payments, negatively impact our ability to sell current or future
products, or that enforcement actions to protect our patent and
proprietary rights against others could be unsuccessful, any of
which could have a material adverse impact on our business,
results of operations, financial condition, and cash flows.
While we intend to defend against any threats to our intellectual
property, our patents, trademarks, tradenames, copyrights,
trade secrets or agreements (such as employee, non-disclosure
and non-competition agreements) may not adequately protect
our intellectual property. Further, pending patent applications
may not result in patents being issued to us, patents issued to or
licensed by us may be challenged or circumvented by
competitors and such patents may be found invalid,
unenforceable or too limited in scope to protect our technology
or provide us with any competitive advantage. Third parties could
obtain patents that may require us to negotiate licenses to
conduct our business, and such licenses may not be available on
reasonable terms or at all. We also rely on non-disclosure and
non-competition agreements with certain employees,
consultants and other parties to protect, in part, trade secrets
and other proprietary rights. We cannot be certain that these
agreements will not be breached, that we will have adequate
remedies for any breach, that others will not independently
develop substantially equivalent proprietary information, or that
third parties will not otherwise gain access to our trade secrets or
proprietary knowledge.
In addition, the laws of certain countries in which we market or
manufacture some of our products do not protect our
intellectual property rights to the same extent as the laws of the
U.S., which could make it easier for competitors to capture
market position. Competitors also may harm our sales by
designing products that substantially mirror the capabilities of
our products or technology without infringing our intellectual
property rights. If we are unable to protect our intellectual
property in these countries, it could have a material adverse
effect on our business, results of operations, financial condition,
and cash flows.
Quality problems and product liability claims
could lead to recalls or safety alerts,
reputational harm, adverse verdicts or costly
settlements, and could have a material
adverse effect on our business, results of
operations, financial condition and cash flows.
Quality is extremely important to us and our customers due to
the impact on patients, and the serious and potentially costly
consequences of product failure. Our business exposes us to
potential product liability risks that are inherent in the design,
manufacture, and marketing of medical devices. In addition,
many of our products are often used in intensive care settings
with seriously ill patients and some of the medical devices we
manufacture and sell are designed to be implanted in the human
body for long periods of time or indefinitely. Component failures,
manufacturing nonconformances, design defects, off-label use,
or inadequate disclosure of product-related risks or product-
related information with respect to our products, if they were to
occur, could result in an unsafe condition or injury to, or death of,
26
MEDTRONIC PLC 2021 Form 10-K
PART I
Item 1A Risk Factors
a patient. These problems could lead to recall of, or issuance of a
safety alert relating to, our products, and could result in product
liability claims and lawsuits, including class actions, which could
ultimately result, in certain cases, in the removal from the body of
such products and claims regarding costs associated therewith.
Due to the strong name recognition of the Medtronic and
Covidien brands, a material adverse event involving one of our
products could result in reduced market acceptance and
demand for all products within that brand, and could harm our
reputation and ability to market products in the future. Further,
we may be exposed to additional potential product liability risks
related to products designed, manufactured and/or marketed in
response to the COVID-19 pandemic, and unpredictable or
accelerated changes in demand for certain of our products in
connection with COVID-19 and its related impacts could impact
development and production of products and services and could
increase the risk of regulatory enforcement actions, product
defects or related claims, as well as adversely impact our
customer relationships and reputation.
Strong product quality is critical to the success of our goods and
services. If we fall short of these standards and our products are
the subject of recalls or safety alerts, our reputation could be
damaged, we could lose customers and our revenue and results
of operations could decline. Our success also can depend on our
ability to manufacture to exact specification precision-
engineered components, subassemblies and finished devices
from multiple materials. If our components fail to meet these
standards or fail to adapt to evolving standards, our reputation,
competitive advantage and market share could be harmed. In
certain situations, we may undertake a voluntary recall of
products or temporarily shut down production lines based on
performance relative to our own internal safety and quality
monitoring and testing data.
Any of the foregoing problems, including future product liability
claims or recalls, regardless of their ultimate outcome, could harm
our reputation and have a material adverse effect on our
business, results of operations, financial condition and cash flows.
Healthcare policy changes may have a
material adverse effect on us.
In response to perceived increases in healthcare costs in recent
years, there have been and continue to be proposals by several
governments, regulators and third-party payers globally,
including the U.S. federal and state governments, to control
these costs and, more generally, to reform healthcare systems.
Certain of these proposals could, among other things, limit the
prices we are able to charge for our products or the amounts of
reimbursement available for our products and could limit the
acceptance and availability of our products. The adoption of
some or all of these proposals could have a material adverse
effect on our business, results of operations, financial condition
and cash flows.
Our insurance program may not be adequate
to cover future losses.
We have elected to self-insure most of our insurable risks across
the Company, and we made this decision based on cost and
availability factors in the insurance marketplace. We manage and
maintain a portion of our self-insured program through a wholly-
owned captive insurance company. We continue to maintain a
directors and officers liability insurance policy with third-party
insurers that provides coverage for the directors and officers of
the Company. We continue to monitor the insurance
marketplace to evaluate the value of obtaining insurance
coverage for other categories of losses in the future. Although
we believe, based on historical loss trends, that our self-
insurance program accruals and our existing insurance coverage
will be adequate to cover future losses, historical trends may not
be indicative of future losses. The absence of third-party
insurance coverage for other categories of losses increases our
exposure to unanticipated claims and these losses could have a
material adverse impact on our business, results of operations,
financial condition and cash flows.
The failure to comply with anti-corruption
laws could materially adversely affect our
business and result in civil and/or criminal
sanctions.
The U.S. Foreign Corrupt Practices Act (FCPA), the Irish Criminal
Justice (Corruption Offences) Act 2018, and similar anti-
corruption laws in other jurisdictions generally prohibit
companies and their intermediaries from making improper
payments to government officials for the purpose of obtaining or
retaining business. Because of the predominance of
government-administered healthcare systems in many
jurisdictions around the world, many of our customer
relationships outside of the U.S. are with governmental entities
and are therefore potentially subject to such laws. We also
participate in public-private partnerships and other commercial
and policy arrangements with governments around the globe.
Global enforcement of anti-corruption laws has increased in
recent years, including investigations and enforcement
proceedings leading to assessment of significant fines and
penalties against companies and individuals. Our international
operations create a risk of unauthorized payments or offers of
payments by one of our employees, consultants, sales agents, or
distributors. We maintain policies and programs to implement
safeguards to educate our employees and agents on these legal
requirements, and to prevent and prohibit improper practices.
However, existing safeguards and any future improvements may
not always be effective, and our employees, consultants, sales
agents or distributors may engage in conduct for which we could
be held responsible. In addition, regulators could seek to hold us
liable for conduct committed by companies in which we invest or
that we acquire. Any alleged or actual violations of these
regulations may subject us to government scrutiny, criminal or
civil sanctions and other liabilities, including exclusion from
government contracting, and could disrupt our business,
adversely affect our reputation and result in a material adverse
effect on our business, results of operations, financial condition
and cash flows.
MEDTRONIC PLC 2021 Form 10-K 27
PART I
Item 1A Risk Factors
Laws and regulations governing international
business operations could adversely impact
our business.
The U.S. Department of the Treasury’s Office of Foreign Assets
Control (OFAC), and the Bureau of Industry and Security at the
U.S. Department of Commerce (BIS), administer certain laws and
regulations that restrict U.S. persons and, in some instances,
non-U.S. persons, in conducting activities, transacting business
with or making investments in certain countries, governments,
entities and individuals subject to U.S. economic sanctions. Our
international operations subject us to these laws and regulations,
which are complex, restrict our business dealings with certain
countries, governments, entities, and individuals, and are
constantly changing. Further restrictions may be enacted,
amended, enforced or interpreted in a manner that materially
impacts our operations.
From time to time, certain of our subsidiaries have limited
business dealings in countries subject to comprehensive
sanctions, including Iran, Sudan, Syria, Cuba and the region of
Crimea. Certain of our subsidiaries sell medical devices, and may
provide related services, to distributors and other purchasing
bodies in such countries. These business dealings represent an
insignificant amount of our consolidated revenues and income,
but expose us to a heightened risk of violating applicable
sanctions regulations. Violations of these regulations are
punishable by civil penalties, including fines, denial of export
privileges, injunctions, asset seizures, debarment from
government contracts and revocations or restrictions of
licenses, as well as criminal fines and imprisonment. We have
established policies and procedures designed to assist with our
compliance with such laws and regulations. However, there can
be no assurance that our policies and procedures will prevent us
from violating these regulations in every transaction in which we
may engage, and such a violation could adversely affect our
reputation, business, results of operations, financial condition,
and cash flows.
We are subject to environmental laws and
regulations and the risk of environmental
liabilities, violations and litigation.
We are subject to numerous U.S. federal, state, local and
non-U.S. environmental, health and safety laws and regulations
concerning, among other things, the health and safety of our
employees, the generation, storage, use and transportation of
hazardous materials, emissions or discharges of substances into
the environment, investigation and remediation of hazardous
substances or materials at various sites, chemical constituents in
medical products and end-of-life disposal and take-back
programs for medical devices. Our operations and those of
certain third-party suppliers involve the use of substances
subject to these laws and regulations, primarily those used in
manufacturing and sterilization processes. If we or our suppliers
violate these environmental laws and regulations, facilities could
be shut down and violators could be fined, criminally charged or
otherwise sanctioned. Furthermore, environmental laws outside
of the U.S. are becoming more stringent, resulting in increased
costs and compliance burdens.
In addition, certain environmental laws assess liability on current
or previous owners or operators of real property for the costs of
investigation, removal or remediation of hazardous substances
or materials at their properties or at properties which they have
disposed of hazardous substances. In addition to cleanup
actions brought by governmental authorities, private parties
could bring personal injury or other claims due to the presence
of, or exposure to, hazardous substances. The ultimate cost of
site cleanup and timing of future cash outflows is difficult to
predict, given the uncertainties regarding the extent of the
required cleanup, the interpretation of applicable laws and
regulations, and alternative cleanup methods.
The costs of complying with current or future environmental
protection and health and safety laws and regulations, or
liabilities arising from past or future releases of, or exposures to,
hazardous substances, may exceed our estimates, or have a
material adverse effect on our business, results of operations,
financial condition, and cash flows.
We rely on the proper function, security and
availability of our information technology
systems and data, as well as those of third
parties throughout our global supply chain, to
operate our business, and a breach, cyber-
attack or other disruption to these systems or
data could materially and adversely affect our
business, results of operations, financial
condition, cash flows, reputation or
competitive position.
We are increasingly dependent on sophisticated information
technology systems to operate our business. That technology
includes systems that could be used to process, transmit and
store sensitive data. Additionally, many of our products and
services include integrated software and information technology
that collects data regarding patients or connects to other
internal systems. Like all organizations, we routinely experience
attempted interference with the integrity of, and interruptions in,
our technology systems via events such as cyber-attacks,
malicious intrusions, or other breakdowns. The consequences
could mean data breaches, interference with the integrity of our
products and data, or other significant disruptions. Furthermore,
we rely on third-party vendors to supply and/or support certain
aspects of our information technology systems and resulting
products. As we have seen with recent “Supply Chain Attacks,”
these third-party systems could also become vulnerable to
cyber-attack, malicious intrusions, breakdowns, interference or
other significant disruptions, and may contain defects in design
or manufacture or other problems that could result in system
disruption or compromise the information security of our own
systems. Lastly, we continue to grow in part through new
business acquisitions and, as a result, may face risks associated
with defects and vulnerabilities in their systems, or difficulties or
other breakdowns or disruptions in connection with the
integration of the acquisitions into our information technology
systems.
28
MEDTRONIC PLC 2021 Form 10-K
PART I
Item 1A Risk Factors
Our worldwide operations mean that we are subject to laws and
regulations, including data protection and cybersecurity laws and
regulations, in many jurisdictions. The variety of U.S. and
international privacy and cybersecurity laws and regulations
impacting our operations are described in “Item 1. Business” –
Other Factors Impacting Our Operations Data Privacy and
Security Laws and Regulations. For example, GDPR prefers that
we manage personal data in the E.U. and may impose fines of up
to four percent of our global revenue in the event of certain
violations. Furthermore, there has been a developing trend of
civil lawsuits and class actions relating to breaches of consumer
data held by large companies or incidents arising from other
cyber-attacks. Any data security breaches, cyber-attacks,
malicious intrusions or significant disruptions could result in
actions by regulatory bodies and/or civil litigation, any of which
could materially and adversely affect our business, results of
operations, financial condition, cash flows, reputation or
competitive position.
In addition, our information technology systems require an
ongoing commitment of significant resources to maintain,
protect, and enhance existing systems and develop new
systems. This enables us to keep pace with continuing changes
in information processing technology, evolving legal and
regulatory standards, the increasing need to protect patient and
customer information, changes in the techniques used to obtain
unauthorized access to data and information systems, and the
information technology needs associated with our changing
products and services. There can be no assurance that our
extensive efforts (including, but not limited to, consolidating,
protecting, upgrading and expanding our systems and
capabilities, continuing to build security into the design of our
products, and developing new systems to keep pace with
continuing changes in information processing technology) will be
successful or that additional systems issues will not arise in the
future. Further, the COVID-19 pandemic and related
government actions continues to mandate that our employees
work remotely, which could expose us to greater risks related to
cybersecurity and our information technologies systems.
If our information technology systems, products or services or
sensitive data are compromised, there are many consequences
that could result. Consequences include, but are not limited to
patients or employees could be exposed to financial or medical
identity theft or suffer a loss of product functionality, losing
existing customers or have difficulty attracting new customers,
experiencing difficulty preventing, detecting, and controlling
fraud, be exposed to the loss or misuse of confidential
information, have disputes with customers, physicians, and other
healthcare professionals, suffer regulatory sanctions or penalties
under federal laws, state laws, or the laws of other jurisdictions,
experience increases in operating expenses or an impairment in
our ability to conduct our operations, incur expenses or lose
revenues as a result of a data privacy breach, product failure,
information technology outages or disruptions, or suffer other
adverse consequences including lawsuits or other legal action
and damage to our reputation.
Changes in tax laws or exposure to additional
income tax liabilities could have a material
impact on our business, results of operations,
financial condition and cash flows.
We are subject to income taxes, as well as non-income based
taxes, in the U.S., Ireland, and various other jurisdictions in which
we operate. The tax laws in the U.S., Ireland and other countries
in which we and our affiliates do business could change on a
prospective or retroactive basis, and any such changes could
materially adversely affect our business and our effective tax
rate. For example, on December 22, 2017, the U.S. enacted
comprehensive tax legislation, commonly referred to as the Tax
Cuts and Jobs Act (the “Tax Act”), which resulted in a significant
charge to tax expense during our fiscal year 2018 associated
with U.S. taxation of accumulated foreign earnings as well as the
requirement to revalue U.S. deferred tax assets and liabilities
resulting from the reduction in the U.S. corporate tax rate. While
the U.S. Treasury has issued a significant amount of guidance to
date on the interpretation of the Tax Act, there remains
regulations that have not yet been issued in final form. In
addition, the Biden Administration has provided a framework for
proposed U.S. tax law changes, which if enacted could have a
material impact on our business, results of operations, financial
condition, and cash flows.
In 2015, the Organization for Economic Cooperation and
Development (OECD) published an action plan called Base
Erosion and Profit Shifting (BEPS) with the purpose of tackling
perceived tax abuses, inconsistency between taxing authorities,
and their respective approach to international tax matters.
Thereafter, many taxing authorities have adopted the BEPS
guidelines into their local laws. In addition, the European Union
(EU) expanded upon these guidelines with their Anti-Tax
Avoidance Directive (ATAD 1 & 2) to be applied by all member
states by 2020. In 2018, the OECD announced its intention to
expand the scope of BEPS (BEPS 2.0) to provide a long-term
solution to taxing right challenges arising from the global digital
economy. The OECD expects to release the final agreed BEPS
2.0 guidelines in the summer of 2021. Jurisdictions would then
need to enact legislation to adopt the guidelines into law. The
proposals, as currently drafted, are categorized into two groups
(commonly referred to as Pillars). Pillar One is focused on
providing a mechanism for taxing rights more closely with market
engagement; generally where people or consumers are located.
Pillar Two is focused on establishing a global minimum tax and
would apply when a country’s income tax rate is below a
still-to-be determined, minimum tax rate. These proposals are
wide ranging and could affect all multinational enterprises across
all industries without regard to their level of engagement with the
digital economy. The aggressive nature of the timeline set by the
OECD may mean that all implications for business may not have
been fully worked through or fully understood by the OECD
before final guidelines are issued. We continue to monitor the
implications potentially resulting from this guidance. This action
together with other legislative changes in many countries on the
mandatory sharing of company information (financial and
operational) with taxing authorities on a local and global basis
under various information sharing initiatives, could lead to
disagreements between jurisdictions associated with the proper
allocation of profits between such jurisdictions.
MEDTRONIC PLC 2021 Form 10-K 29
PART I
Item 1A Risk Factors
We are subject to ongoing tax audits in the various jurisdictions in
which we operate. Tax authorities may disagree with certain
positions we have taken and assess additional taxes. We
regularly assess the likely outcomes of these audits in order to
determine the appropriateness of our tax provision. However,
there can be no assurance that we will accurately predict the
outcomes of these audits, and the actual outcomes of these
audits could have a material impact on our business, results of
operations, financial condition, and cash flows.
We have recorded reserves for potential payments of tax to
various tax authorities related to uncertain tax positions.
However, the calculation of such tax liabilities involves the
application of complex tax laws, regulations and treaties (where
applicable) in many jurisdictions. Therefore, any dispute with a tax
authority may result in a payment that is significantly different
from current estimates. If payment of these amounts ultimately
proves to be less than the recorded amounts, the reversal of the
liabilities generally would result in tax benefits being recognized in
the period when we determine the liabilities are no longer
necessary. If our estimate of tax liabilities proves to be less than
the amount for which it is ultimately liable, we would incur
additional charges, and such charges could have a material
adverse effect on our business, results of operations, financial
condition, and cash flows.
The Medtronic, Inc. tax court proceeding
outcome could have a material adverse
impact on our financial condition.
In March 2009, the IRS issued its audit report for Medtronic Inc.
for fiscal years 2005 and 2006. Medtronic, Inc. reached
agreements with the IRS on some, but not all matters related to
these fiscal years. The remaining unresolved issue for fiscal years
2005 and 2006 relates to the allocation of income between
Medtronic, Inc. and its wholly-owned subsidiary operating in
Puerto Rico, which is one of our key manufacturing sites. An
adverse outcome in this matter could materially and adversely
affect our business, results of operations, financial condition, and
cash flows. See Note 18 to the consolidated financial statements
in “Item 8. Financial Statements and Supplementary Data” in this
Annual Report on Form 10-K.
Future potential changes to the U.S. tax laws
could result in us being treated as a U.S.
corporation for U.S. federal tax purposes, and
the IRS may not agree with the conclusion
that we should be treated as a foreign
corporation for U.S federal income tax
purposes.
Because Medtronic plc is organized under the laws of Ireland, we
would generally be classified as a foreign corporation under the
general rule that a corporation is considered tax resident in the
jurisdiction of its organization or incorporation for U.S. federal
income tax purposes. Even so, the IRS may assert that we should
be treated as a U.S. corporation (and, therefore, a U.S. tax
resident) for U.S. federal income tax purposes pursuant to
Section 7874 of the U.S. Internal Revenue Code of 1986, as
amended (the Code). In addition, a retroactive change to U.S. tax
laws in this area could change this classification. If we were to be
treated as a U.S. corporation for federal tax purposes, we could
be subject to substantially greater U.S. tax liability than currently
contemplated as a non-U.S. corporation.
Legislative or other governmental action
relating to the denial of U.S. federal or state
governmental contracts to U.S. companies
that redomicile abroad could adversely affect
our business.
Various U.S. federal and state legislative proposals that would
deny governmental contracts to U.S. companies that move their
corporate location abroad may affect us. We are unable to
predict the likelihood that, or final form in which, any such
proposed legislation might become law, the nature of the
regulations that may be promulgated under any future legislative
enactments, or the effect such enactments and increased
regulatory scrutiny may have on our business.
Risks Relating to Our Jurisdiction of Incorporation
We are incorporated in Ireland, and Irish law
differs from the laws in effect in the U.S. and
may afford less protection to holders of our
securities.
Our shareholders may have more difficulty protecting their
interests than would shareholders of a corporation incorporated
in a jurisdiction of the United States. It may not be possible to
enforce court judgments obtained in the U.S. against us in Ireland
based on the civil liability provisions of the U.S. federal or state
securities laws. In addition, there is some uncertainty as to
whether the courts of Ireland would recognize or enforce
judgments of U.S. courts obtained against us or our directors or
officers based on the civil liabilities provisions of the U.S. federal
or state securities laws or hear actions against us or those
persons based on those laws. We have been advised that the
U.S. currently does not have a treaty with Ireland providing for
the reciprocal recognition and enforcement of judgments in civil
and commercial matters. Therefore, a final judgment for the
payment of money rendered by any U.S. federal or state court
based on civil liability, whether or not based solely on U.S. federal
or state securities laws, would not automatically be enforceable
in Ireland.
As an Irish company, we are governed by the Irish Companies Act
2014, which differs in some material respects from laws generally
applicable to U.S. corporations and shareholders, including,
30
MEDTRONIC PLC 2021 Form 10-K
PART I
Item 1A Risk Factors
among others, differences relating to interested director and
officer transactions and shareholder lawsuits. Likewise, the
duties of directors and officers of an Irish company generally are
owed to the company only. Shareholders of Irish companies
generally do not have a personal right of action against directors
or officers of the company and may exercise such rights of
action on behalf of the company only in limited circumstances.
Accordingly, holders of our securities may have more difficulty
protecting their interests than would holders of securities of a
corporation incorporated in the U.S.
As an Irish public limited company, certain
capital structure decisions require
shareholder approval, which may limit
Medtronic’s flexibility to manage its capital
structure.
Under Irish law, our authorized share capital can be increased by
an ordinary resolution of our shareholders and the directors may
issue new ordinary or preferred shares, without shareholder
approval, once authorized to do so by our articles of association
or by an ordinary resolution of our shareholders. Additionally,
subject to specified exceptions, Irish law grants statutory
preemption rights to existing shareholders where shares are
being issued for cash consideration but allows shareholders to
disapply such statutory preemption rights either in our articles of
association or by way of special resolution. Such disapplication
can either be generally applicable or be in respect of a particular
allotment of shares. Accordingly, at our 2020 Annual General
Meeting, our Shareholders authorized our Board of Directors to
issue up to 33% of our issued ordinary shares and further
authorized our Board of Directors to issue up to 10% of such
shares for cash without first offering them to our existing
shareholders (provided that with respect to 5% of such shares,
such allotment is to be used for the purposes of a specified
capital investment). Both of these authorizations will expire on
June 11, 2022, unless renewed by shareholders for a further
period. We anticipate seeking new authorizations at our 2021
Annual General Meeting and in subsequent years. We cannot
provide any assurance that these authorizations will always be
approved, which could limit our ability to issue equity and thereby
adversely affect the holders of our securities.
A transfer of our shares, other than ones
effected by means of the transfer of book-
entry interests in the Depository Trust
Company, may be subject to Irish stamp duty.
Transfers of our shares effected by means of the transfer of
book entry interests in the Depository Trust Company (DTC) will
not be subject to Irish stamp duty. However, if a shareholder
holds our shares directly rather than beneficially through DTC,
any transfer of shares could be subject to Irish stamp duty
(currently at the rate of 1% of the higher of the price paid or the
market value of the shares acquired). Payment of Irish stamp
duty is generally a legal obligation of the transferee. The potential
for stamp duty could adversely affect the price of shares.
In certain limited circumstances, dividends we
pay may be subject to Irish dividend
withholding tax and dividends received by
Irish residents and certain other shareholders
may be subject to Irish income tax.
In certain limited circumstances, dividend withholding tax
(currently at a rate of 25%) may arise in respect of dividends paid
on our shares. A number of exemptions from dividend
withholding tax exist such that shareholders resident in the U.S.
and other specified countries that have a tax treaty with Ireland
may be entitled to exemptions from dividend withholding tax.
Shareholders resident in the U.S. that hold their shares through
DTC will not be subject to dividend withholding tax, provided the
addresses of the beneficial owners of such shares in the records
of the brokers holding such shares are recorded as being in the
U.S. (and such brokers have further transmitted the relevant
information to a qualifying intermediary appointed by us).
However, other shareholders may be subject to dividend
withholding tax, which could adversely affect the price of their
shares.
Shareholders entitled to an exemption from Irish dividend
withholding tax on dividends received from us will not be subject
to Irish income tax in respect of those dividends unless they have
some connection with Ireland other than their shareholding in
our Company (for example, they are resident in Ireland).
Shareholders who receive dividends subject to Irish dividend
withholding tax generally have no further liability to Irish income
tax on those dividends.
Our shares received by means of a gift or
inheritance could be subject to Irish capital
acquisitions tax.
Irish capital acquisitions tax (CAT) could apply to a gift or
inheritance of our shares irrespective of the place of residence,
ordinary residence or domicile of the parties. This is because our
shares will be regarded as property situated in Ireland. The
person who receives the gift or inheritance has primary liability
for CAT. Gifts and inheritances passing between spouses are
exempt from CAT. Children have a tax-free threshold of
335,000 in respect of taxable gifts or inheritances received
from their parents. Irish Revenue typically updates the amount of
this tax-free threshold on an annual basis.
MEDTRONIC PLC 2021 Form 10-K 31
PART I
Item 1A Risk Factors
Economic and Industry Risks
If we experience decreasing prices for our
goods and services and we are unable to
reduce our expenses, there may be a material
adverse effect on our business, results of
operations, financial condition and cash flows.
We have experienced, and may continue to experience,
decreasing prices for certain of our goods and services due to
pricing pressure from managed care organizations and other
third-party payers on our customers, increased market power of
our customers as the medical device industry consolidates and
increased competition among medical engineering and
manufacturing services providers. If the prices for our goods and
services decrease and we are unable to reduce our expenses,
our business, results of operations, financial condition and cash
flows will be adversely affected.
We are subject to a variety of risks associated
with global operations that could adversely
affect our profitability and operating results.
We develop, manufacture, distribute and sell our products
globally. We intend to continue to expand our operations and to
pursue growth opportunities outside the U.S., especially in
emerging markets. Operations in different countries including
emerging markets could expose us to additional and greater
risks and potential costs, including:
fluctuations in currency exchange rates,
healthcare reform legislation,
the need to comply with different regulatory regimes
worldwide that are subject to change and that could restrict
our ability to manufacture and sell our products,
local product preferences and product requirements,
longer-term receivables than are typical in the U.S.,
trade protection measures, tariffs and other border taxes, and
import or export licensing requirements,
less intellectual property protection in some countries outside
the U.S. than exists in the U.S.,
different labor regulations and workforce instability,
political and economic instability,
the expiration and non-renewal of foreign tax rulings and/or
grants,
potentially negative consequences from changes in or
interpretations of tax laws, and
economic instability and inflation, recession or interest rate
fluctuations.
The ongoing global economic competition and trade tensions
between the U.S. and China present risk to Medtronic. Although
we have been able to mitigate some of the impact on Medtronic
from increased duties imposed by both sides (through
petitioning both governments for tariff exclusions and other
mitigations), the risk remains of additional tariffs and other kinds
of restrictions. Tariff exclusions awarded to Medtronic by the
U.S. Government require annual renewal, and policies for
granting exclusions could shift. The U.S. and China could impose
other types of restrictions such as limitations on government
procurement or technology export restrictions, which could
affect Medtronic’s access to the markets. China comprises
approximately eight percent of our total revenues.
More generally, several governments including the U.S. have
raised the possibility of policies to induce “re-shoring” of supply
chains, less reliance on imported supplies, and greater national
production. Examples include potential “Buy America”
requirements in the U.S. or U.S. withdrawal from the World Trade
Organization Agreement on Government Procurement (GPA). If
such steps triggered retaliation in other markets restricting
access to foreign products in purchases by their government-
owned healthcare systems, the result could be a significant
impact on Medtronic.
Other significant changes or disruptions to international trade
arrangements, such as termination or modifications of other
existing trade agreements or the final implementation of the
“Brexit” agreement between the United Kingdom and European
Union, may adversely affect our business, results of operations,
financial condition and cash flows.
In addition, a significant amount of our trade receivables are with
national healthcare systems in many countries. Repayment of
these receivables is dependent upon the political and financial
stability of those countries. In light of these global economic
fluctuations, we continue to monitor the creditworthiness of
customers. Failure to receive payment of all or a significant
portion of these receivables could adversely affect our business,
results of operations, financial condition and cash flows.
In addition, COVID-19, and the responses of business and
governments to the pandemic, have at times resulted in reduced
availability of air transport, port closures, increased border
controls or closures, increased transportation costs and
increased security threats to our supply chain, and countries may
continue to close borders, impose prolonged quarantines, and
further restrict travel and other activities. Our business could be
adversely impacted if we are unable to successfully manage
these and other risks of global operations.
Finally, changes in currency exchange rates may impact the
reported value of our revenues, expenses, and cash flows. We
cannot predict changes in currency exchange rates, the impact
of exchange rate changes, nor the degree to which we will be
able to manage the impact of currency exchange rate changes.
32
MEDTRONIC PLC 2021 Form 10-K
PART I
Item 1B Unresolved Staff Comments
Consolidation in the healthcare industry could
have an adverse effect on our revenues and
results of operations.
Many healthcare industry companies, including healthcare
systems, distributors, manufacturers, providers, and insurers,
are consolidating or have formed strategic alliances. As the
healthcare industry consolidates, competition to provide goods
and services to industry participants will become more intense.
Further, this consolidation creates larger enterprises with
greater negotiating power, which they can use to negotiate price
concessions. If we must reduce our prices because of industry
consolidation, or if we lose customers as a result of
consolidation, our business, results of operations, financial
condition, and cash flows could be adversely affected.
Healthcare industry cost-containment
measures could result in reduced sales of our
medical devices and medical device
components.
Most of our customers, and the healthcare providers to whom
our customers supply medical devices, rely on third-party
payers, including government programs and private health
insurance plans, to reimburse some or all of the cost of the
procedures in which medical devices that incorporate
components we manufacture or assemble are used. The
continuing efforts of governmental authorities, insurance
companies and other payers of healthcare costs to contain or
reduce these costs could lead to patients being unable to obtain
approval for payment from these third-party payers. If third-
party payer payment approval cannot be obtained by patients,
sales of finished medical devices that include our components
may decline significantly and our customers may reduce or
eliminate purchases of our components. The cost-containment
measures that healthcare providers are instituting, both in the
U.S. and outside of the U.S., could harm our ability to operate
profitably. For example, managed care organizations have
successfully negotiated volume discounts for pharmaceuticals,
and GPOs and IDNs have also concentrated purchasing
decisions for some customers, which has led to downward
pricing pressure for medical device companies, including us.
Item 1B. Unresolved Staff Comments
None.
MEDTRONIC PLC 2021 Form 10-K 33
PART I
Item 2 Properties
Item 2. Properties
Medtronic’s principal executive office is located in Ireland and is leased by the Company, while its main operational offices are located in
the Minneapolis, Minnesota metropolitan area and are owned by the Company.
The Company’s total manufacturing and research space is approximately 9.6 million square feet. Approximately 35 percent of the
manufacturing or research facilities are owned by Medtronic and the balance is leased. The following is a summary of the Company’s
largest manufacturing and research facilities by location:
Location Country or State Square Feet (in thousands)
Connecticut 1,138
Puerto Rico
811
Mexico
762
China
735
Minnesota
623
Italy
454
Ireland
446
Dominican Republic
304
Arizona
294
Switzerland
283
France
270
Colorado
259
California 204
Medtronic also maintains sales and administrative offices in the U.S. at six locations in six states and outside the U.S. at 138 locations in
63 countries. Most of these locations are leased. The Company is using substantially all of its currently available productive space to
develop, manufacture, and market its products. The Company’s facilities are well-maintained, suitable for their respective uses, and
adequate for current needs.
Item 3. Legal Proceedings
A discussion of the Company’s legal proceedings is contained in Note 18 to the consolidated financial statements in “Item 8. Financial
Statements and Supplementary Data” in this Annual Report on Form 10-K.
Item 4. Mine Safety Disclosures
Not applicable.
34
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 5. Market for Medtronic’s Common Equity, Related Shareholder
Matters, and Issuer Purchases of Equity Securities
The Company’s ordinary shares are listed on the New York Stock Exchange under the symbol “MDT.”
The following table provides information about the shares repurchased by the Company during the fourth quarter of fiscal year 2021:
Fiscal Period
Total Number
of Shares
Purchased Average Price Paid per Share
Total Number of Shares
Purchased as a Part of
Publicly Announced
Program
Maximum Approximate
Dollar Value of Shares
that may yet be Purchased
Under the Program
1/30/2021-2/26/2021
$ $ 5,950,169,124
2/27/2021-4/2/2021
5,950,169,124
4/3/2021-4/30/2021
4,404,719 126.80 4,404,719 5,391,654,170
Total 4,404,719 $ 126.80 4,404,719 5,391,654,170
In March 2019, the Company’s Board of Directors authorized the
repurchase of $6.0 billion of the Company’s ordinary shares.
There is no specific time-period associated with these
repurchase authorizations.
On June 23, 2021, there were approximately 23,394
shareholders of record of the Company’s ordinary shares.
Ordinary cash dividends declared and paid totaled 58.0 cents per
share for each quarter of fiscal year 2021 and 54.0 cents per
share for each quarter of fiscal year 2020. On May 27, 2021, the
Company announced an increase in Medtronic’s cash dividends
for the first quarter of fiscal year 2022, raising the amount to
$0.63.
STOCK PERFORMANCE GRAPH
The following graph compares the cumulative total shareholder return on Medtronic’s ordinary shares with the cumulative total
shareholder return on the Standard & Poor’s (S&P) 500 Index and the S&P 500 Health Care Equipment Index for the last five fiscal years.
The graph assumes that $100 was invested at market close on April 29, 2016 in Medtronic’s ordinary shares, the S&P 500 Index, and the
S&P 500 Health Care Equipment Index and that all dividends were reinvested.
$0
$50
$100
$150
$200
$300
$250
April 2017
April 2016
April 2018 April 2019 April 2020 April 2021
Medtronic plc
S&P 500 Health Care Equipment Index
S&P 500 Index
100
107
107
118
137
185
100
117
141
165
188
250
118
135
151
149
223
100
MEDTRONIC PLC 2021 Form 10-K 35
PART II
Item 5 Market for Medtronic’s Common Equity, Related Shareholder Matters, and Issuer Purchases of Equity Securities
Company/Index April 2016 April 2017 April 2018 April 2019 April 2020 April 2021
Medtronic plc $ 100.00 $ 107.23 $ 107.29 $ 117.86 $ 136.89 $ 184.54
S&P 500 Index 100.00 117.92 134.66 151.27 148.91 223.20
S&P 500 Health Care Equipment Index 100.00 117.16 141.00 165.48 188.33 249.74
For information on the Company’s equity compensation plans, see “Item 12. Security Ownership of Certain Beneficial Owners and
Management and Related Shareholder Matters” in this Annual Report on Form 10-K.
IRISH RESTRICTIONS ON IMPORT AND EXPORT OF CAPITAL
Except as indicated below, there are no restrictions on
non-residents of Ireland dealing in Irish domestic securities,
which includes ordinary shares of Irish companies. Except as
indicated below, dividends and redemption proceeds also
continue to be freely transferable to non-resident holders of
such securities. The Financial Transfers Act, 1992 provides that
the Irish Minister for Finance can make provision for the
restriction of financial transfers between Ireland and other
countries. For the purposes of this Act, “financial transfers”
include all transfers which would be movements of capital or
payments within the meaning of the treaties governing the E.U. if
they had been made between Member States of the E.U. This
Act has been used by the Minister for Finance to implement
European Council Directives, which provide for the restriction of
financial transfers to certain countries, organizations, and people
including the Al-Qaeda network and the Taliban, Afghanistan,
Belarus, Burma (Myanmar), Democratic People’s Republic of
Korea, Democratic Republic of Congo, Iran, Iraq, Ivory Coast,
Lebanon, Liberia, Libya, Republic of Guinea, Somalia, Sudan,
Syria, Tunisia, Ukraine and Zimbabwe.
Any transfer of, or payment in respect of, a share or interest in a
share involving the government of any country that is currently
the subject of United Nations sanctions, any person or body
controlled by any of the foregoing, or by any person acting on
behalf of the foregoing, may be subject to restrictions pursuant
to such sanctions as implemented into Irish law.
IRISH TAXES APPLICABLE TO U.S. HOLDERS
Dividends paid by Medtronic will generally be subject to Irish
dividend withholding tax (currently at a rate of 25 percent) unless
an exemption applies.
Dividends paid to U.S. residents will not be subject to Irish
dividend withholding tax provided that:
in the case of a beneficial owner of Medtronic shares held in
the Depository Trust Company (DTC), the address of the
beneficial owner in the records of his or her broker is in the
United States and this information is provided by the broker to
the Company’s qualifying intermediary; or
in the case of a record owner, the record owner has provided
to the Company’s transfer agent a valid U.S. Certification of
Residence (Form 6166) or valid Irish Non-Resident Form V2.
Irish income tax may also arise with respect to dividends paid on
Medtronic’s ordinary shares. A U.S. resident who meets one of
the exemptions from dividend withholding tax described above
and who does not hold Medtronic shares through a branch or
agency in Ireland through which a trade is carried on generally will
not have any Irish income tax liability on a dividend paid by
Medtronic. In addition, if a U.S. shareholder is subject to the
dividend withholding tax, the withholding payment discharges
any Irish income tax liability, provided the shareholder furnishes
to the Irish Revenue authorities a statement of the dividend
withholding tax imposed.
While the U.S./Ireland Double Tax Treaty contains provisions
regarding withholding, due to the wide scope of the exemptions
from dividend withholding tax available under Irish domestic law,
it would generally be unnecessary for a U.S. resident shareholder
to rely on the treaty provisions.
Item 6. Reserved
36 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 7. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
The following discussion and analysis provides information
management believes to be relevant to understanding the
financial condition and results of operations of the Company.
The discussion focuses on our financial results for the fiscal year
ended April 30, 2021 (fiscal year 2021) and the fiscal year ended
April 24, 2020 (fiscal year 2020). A discussion on our results of
operations for fiscal year 2020 as compared the year ended
April 26, 2019 (fiscal year 2019) is included in Part II, Item 7.
“Management’s Discussion and Analysis of Financial Condition
and Results of Operations” of our Annual Report on Form 10-K
for the year ended April 24, 2020, filed with the SEC on June 19,
2020, and is incorporated by reference into this Form 10-K. You
should read this discussion and analysis along with our
consolidated financial statements and related notes thereto at
April 30, 2021 and April 24, 2020 and for fiscal years 2021, 2020,
and 2019, which are presented within “Item 8. Financial
Statements and Supplementary Data” in this Annual Report on
Form 10-K. Amounts reported in millions within this annual
report are computed based on the amounts in thousands, and
therefore, the sum of the components may not equal the total
amount reported in millions due to rounding. Additionally, certain
columns and rows within tables may not sum due to rounding.
Throughout this Management’s Discussion and Analysis, we
present certain financial measures that we use to evaluate the
operational performance of the Company and as a basis for
strategic planning; however, such financial measures are not
presented in our financial statements prepared in accordance
with accounting principles generally accepted in the U.S. (U.S.
GAAP). These financial measures are considered “non-GAAP
financial measures” and are intended to supplement, and should
not be considered as superior to, financial measures presented
in accordance with U.S. GAAP. We generally use non-GAAP
financial measures to facilitate management’s review of the
operational performance of the Company and as a basis for
strategic planning. We believe that non-GAAP financial
measures provide information useful to investors in
understanding the Company’s underlying operational
performance and trends and may facilitate comparisons with the
performance of other companies in the medical technologies
industry.
As presented in the GAAP to Non-GAAP Reconciliations section
below, our non-GAAP financial measures exclude the impact of
certain charges or benefits that contribute to or reduce earnings
and that may affect financial trends, and include certain charges
or benefits that result from transactions or events that we
believe may or may not recur with similar materiality or impact to
our operations in future periods (Non-GAAP Adjustments).
In the event there is a Non-GAAP Adjustment recognized in our
operating results, the tax cost or benefit attributable to that item
is separately calculated and reported. Because the effective rate
can be significantly impacted by the Non-GAAP Adjustments
that take place during the period, we often refer to our tax rate
using both the effective rate and the non-GAAP nominal tax rate
(Non-GAAP Nominal Tax Rate). The Non-GAAP Nominal Tax
Rate is calculated as the income tax provision, adjusted for the
impact of Non-GAAP Adjustments, as a percentage of income
before income taxes, excluding Non-GAAP Adjustments.
Free cash flow is a non-GAAP financial measure calculated by
subtracting property, plant, and equipment additions from
operating cash flows.
Refer to the “GAAP to Non-GAAP Reconciliations,” “Income
Taxes,” and “Free Cash Flow” sections for reconciliations of the
non-GAAP financial measures to their most directly comparable
financial measures prepared in accordance with U.S. GAAP.
EXECUTIVE LEVEL OVERVIEW
The global healthcare system faces an unprecedented challenge
as a result of the Covid-19 pandemic. COVID-19 had an adverse
impact on certain aspects of our Company and business,
including the demand for and supply of certain of our products,
operations, supply chains and distribution systems, impacts or
delays to product development milestones, clinical trials, or
regulatory clearances and approval timing. Most of our
businesses were affected by a decline in procedural volumes as a
result of COVID-19 largely during the fourth quarter of fiscal year
2020 and the first two quarters of fiscal year 2021. However, we
have seen a recovery in most of our businesses during the third
and fourth quarters of fiscal year 2021 from the depths of the
pandemic that we experienced in the fourth quarter of fiscal year
2020.
We expect medical procedure recovery rates to continue to vary
by therapy and country and could be impacted by regional
COVID-19 case volumes, vaccine immunization rates, and new
COVID-19 variants. As a result, we cannot predict with
confidence the duration of the pandemic or the impact it may
have on our Company.
MEDTRONIC PLC 2021 Form 10-K 37
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following is a summary of revenue, diluted earnings per share, and cash flow for fiscal years 2021 and 2020:
$30.1B $2.66 $4.44
$6.2B
GAAP
Revenue increase of 4% reflects our recovery to
date from the depths of COVID-19 experienced in
the fourth quarter of fiscal year 2020.
Diluted EPS decreased
$0.88 or 25% primarily
attributable to the
decrease in tax benefit
driven by the prior year
release of a valuation
allowance, decrease in
gross margin, increase in
restructuring and
associated costs, and the
impact of currency
exchange rate changes.
Non-GAAP Diluted EPS
decreased $0.15 or 3%
primarily due to the
decrease in gross margin
and the impact of
currency exchange rate
changes.
Operating cash flow decrease of $1B primarily
driven by a decrease in cash collected from
customers and increase in cash paid for income
taxes.
GAAP GAAPNon-GAAP
REVENUE
(in billions)
Fiscal Year 2021
$30.1
$28.9
Fiscal Year 2020
DILUTED EPS
Fiscal Year 2021 Fiscal Year 2020
$2.66
$4.44
$3.54
$4.59
GAAP Non-GAAP
OPERATING
CASH FLOW
(in billions)
Fiscal Year 2021 Fiscal Year 2020
$7.2
$6.2
Non-GAAP Reconciliations The tables below present reconciliations of our Non-GAAP financial measures to the most directly
comparable financial measures prepared in accordance with U.S. GAAP for fiscal years 2021 and 2020:
Fiscal year ended April 30, 2021
(in millions, except per share data)
Income Before
Income Taxes
Income Tax
Provision
(Benefit)
Net Income
Attributable to
Medtronic Diluted EPS
Effective Tax
Rate
GAAP $ 3,895 $ 265 $ 3,606 $ 2.66 6.8%
Non-GAAP Adjustments:
Restructuring and associated costs
(1)
617 128 489 0.36 20.7
Acquisition-related items
(2)
(15) (20) 4 126.7
Certain litigation charges 118 23 95 0.07 19.5
(Gain)/loss on minority investments
(3)
(61) (57) (0.04)
IPR&D charges
(4)
31 7 25 0.02 19.4
Impairment charges
(5)
76 7 68 0.05 10.5
Medical device regulations
(6)
83 15 68 0.05 18.1
Debt tender premium and other charges
(7)
308 60 248 0.18 19.5
Amortization of intangible assets 1,783 283 1,500 1.11 15.9
Certain tax adjustments, net
(8)
41 (41) (0.03)
Non-GAAP $ 6,835 $ 809 $ 6,005 $ 4.44 11.8%
38 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
Fiscal year ended April 24, 2020
(in millions, except per share data)
Income Before
Income Taxes
Income Tax
(Benefit)
Provision
Net Income
Attributable to
Medtronic Diluted EPS
Effective Tax
Rate
GAAP $ 4,055 $ (751) $ 4,789 $ 3.54 (18.5)%
Non-GAAP Adjustments:
Restructuring and associated costs
(1)
441 69 372 0.28 15.6
Acquisition-related items
(9)
66 13 53 0.04 19.7
Certain litigation charges 313 59 254 0.19 18.8
(Gain)/loss on minority investments
(3)
19 (3) 22 0.02 (15.8)
Debt tender premium and other charges
(10)
406 86 320 0.24 21.2
Medical device regulations
(6)
48 6 42 0.03 12.5
Exit of businesses
(11)
52 12 40 0.03 23.1
IPR&D charges
(4)
25 3 22 0.02 12.0
Contribution to Medtronic Foundation 80 18 62 0.05 22.5
Amortization of intangible assets 1,756 284 1,472 1.09 16.2
Certain tax adjustments, net
(12)
1,242 (1,242) (0.92)
Non-GAAP $ 7,261 $ 1,038 $ 6,206 $ 4.59 14.3%
(1) Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program and
consulting expenses.
(2) The charges primarily include business combination transaction-related costs, changes in fair value of contingent consideration, and a change in
amounts accrued for certain contingent liabilities for recent acquisitions.
(3) We exclude unrealized and realized gains and losses on our minority investments as we do not believe these components of income or expense
have a direct correlation to our ongoing or future business operations.
(4) The charges represent acquired IPR&D in connection with asset acquisitions and certain license payments for unapproved technology.
(5) The charges relate to the abandonment of certain intangible assets in our Neuroscience segment.
(6) The charges represent estimated incremental costs of complying with the new European Union medical device regulations for previously
registered products and primarily include charges for contractors supporting the project and other direct third-party expenses.
(7) The charges relate to the early redemption of approximately $6.0 billion of debt.
(8) The net benefit primarily relates to the finalization of an audit at the IRS Appellate level for fiscal years 2012 through 2014 and the capitalization of
certain research and development costs for U.S. income tax purposes, which are partially offset by the impact of an intercompany sale of assets,
and a tax basis adjustment and amortization of previously established deferred tax assets from intercompany intellectual property transactions.
(9) The charges primarily include costs incurred in connection with legacy-Covidien enterprise resource planning deployment activities, business
combination related costs, and changes in fair value of contingent consideration.
(10) The charges, which include $413 million recognized in interest expense and ($7 million) recognized in other operating expense, net, primarily relates
to the early redemption of approximately $5.2 billion of debt.
(11) The net charges relate to the exit of businesses and are primarily comprised of intangible asset impairments.
(12) The net benefit primarily relates to the release of a valuation allowance on certain net operating losses, the impact of an intercompany sale of
intellectual property, and the impact of tax reform in Switzerland and the United States.
Free Cash Flow
Free cash flow, a non-GAAP financial measure, is calculated by subtracting additions to property, plant, and equipment from net cash
provided by operating activities. Management uses this non-GAAP financial measure, in addition to U.S. GAAP financial measures, to
evaluate our operating results. Free cash flow should be considered supplemental to, and not a substitute for, our reported financial
results prepared in accordance with U.S. GAAP. Reconciliations between net cash provided by operating activities (the most comparable
U.S. GAAP measure) and free cash flow are as follows:
Fiscal Year
(in millions) 2021 2020
Net cash provided by operating activities $ 6,240 $ 7,234
Additions to property, plant, and equipment (1,355) (1,213)
Free cash flow $ 4,885 $ 6,021
MEDTRONIC PLC 2021 Form 10-K 39
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
NET SALES
Segment and Division
The charts below illustrate the percent of net sales by segment for fiscal years 2021 and 2020:
Fiscal Year 2021 Fiscal Year 2020
36%
8%
27%
29%
Cardiovascular
Diabetes
Medical Surgical
Neuroscience
36%
8%
27%
29%
Cardiovascular
Diabetes
Medical Surgical
Neuroscience
The table below includes net sales by segment and division for fiscal years 2021 and 2020:
Net Sales by Fiscal Year
Percent Change(in millions) 2021 2020
Cardiac Rhythm & Heart Failure $ 5,584 $ 5,141 9%
Structural Heart & Aortic 2,834 2,842
Coronary & Peripheral Vascular 2,354 2,486 (5)
Cardiovascular 10,772 10,468 3
Surgical Innovations 5,438 5,513 (1)
Respiratory, Gastrointestinal, & Renal 3,298 2,839 16
Medical Surgical 8,737 8,352 5
Cranial & Spinal Technologies 4,288 4,082 5
Specialty Therapies 2,307 2,147 7
Neuromodulation 1,601 1,497 7
Neuroscience 8,195 7,725 6
Diabetes 2,413 2,368 2
Total $ 30,117 $ 28,913 4%
Segment and Market Geography
The charts below illustrate the percent of net sales by market geography for fiscal years 2021 and 2020:
Fiscal Year 2021 Fiscal Year 2020
U.S.
Non-U.S.
Developed
Markets
Emerging
Markets
52%
32%
16%
U.S.
Non-U.S.
Developed
Markets
Emerging
Markets
52%
32%
16%
40 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
The table below includes net sales by market geography for each of our segments for fiscal years 2021 and 2020:
U.S.
(1)
Non-U.S. Developed Markets
(2)
Emerging Markets
(3)
(in millions)
Fiscal Year
2021
Fiscal Year
2020 % Change
Fiscal Year
2021
Fiscal Year
2020 % Change
Fiscal Year
2021
Fiscal Year
2020 % Change
Cardiovascular $ 5,248 $ 5,062 4% $ 3,752 $ 3,519 7% $ 1,773 $ 1,887 (6)%
Medical Surgical 3,650 3,532 3 3,320 3,169 5 1,766 1,651 7
Neuroscience 5,456 5,122 7 1,724 1,659 4 1,015 945 7
Diabetes 1,171 1,204 (3) 1,019 940 8 222 224 (1)
Total $ 15,526 $ 14,919 4% $ 9,815 $ 9,287 6% $ 4,777 $ 4,707 1%
(1) U.S. includes the United States and U.S. territories.
(2) Non-U.S. developed markets include Japan, Australia, New Zealand, Korea, Canada, and the countries within Western Europe.
(3) Emerging markets include the countries of the Middle East, Africa, Latin America, Eastern Europe, and the countries of Asia that are not included in
the non-U.S. developed markets, as defined above.
The increase in net sales for fiscal year 2021 as compared to
fiscal year 2020 was primarily related to the recovery of
procedure volumes as compared to the drastic decline
experienced in the fourth quarter of fiscal year 2020 as a result of
the pandemic. While the recovery of procedural volumes has
been uneven across geographies and our different product lines,
as of the end of fiscal year 2021, procedural volumes in the
majority of our end markets are returning to pre-pandemic
levels. Net sales for fiscal year 2021 were also impacted by an
additional selling week during the first fiscal month of fiscal year
2021 due to our 52/53 week fiscal year calendar. Although we
cannot precisely calculate the impact of the extra selling week,
we estimate that it benefited net sales for fiscal year 2021 by
approximately $360 million to $390 million. Additionally, currency
had a favorable impact on net sales in non-U.S. developed
markets of $427 million and an unfavorable impact on net sales in
emerging markets of $98 million for fiscal year 2021 as
compared to fiscal year 2020.
During the first and fourth quarters of fiscal year 2021, we
realigned our divisions with Neuroscience and Cardiovascular,
respectively. As a result, fiscal year 2020 results have been
recast to adjust for these realignments. Additionally, we
implemented our new operating model in fiscal year 2021, which
was fully operational beginning in the fourth quarter. Our new
operating model simplifies our organization in order to
accelerate decision making, improve commercial execution, and
more effectively leverage the scale of our company. The
“Restructuring Charges, Net” section of this Management’s
Discussion and Analysis has further information regarding our
new operating model.
Looking ahead, the uncertain and uneven global recovery from
COVID-19 and the resulting impact on future procedural
volumes and demand for our products and therapies could
negatively impact our business. Additionally, our segments are
likely to face competitive product launches and pricing pressure,
geographic macro-economic risks, reimbursement challenges,
impacts from changes in the mix of our product offerings,
changes in timing of product registration approvals, replacement
cycle challenges, and fluctuations in currency exchange rates.
Cardiovascular
Cardiovascular products include pacemakers, insertable cardiac
monitors, cardiac resynchronization therapy devices (CRT-D &
CRT-P), implantable cardioverter defibrillators (ICD), leads and
delivery systems, ventricular assist systems, ablation products,
electrophysiology catheters, products for the treatment of atrial
fibrillation, information systems for the management of patients
with Cardiac Rhythm & Heart Failure devices, products designed
to reduce surgical site infections, coronary and peripheral stents
and related delivery systems, balloons and related delivery
systems, endovascular stent graft systems, heart valve
replacement technologies, cardiac tissue ablation systems, and
open heart and coronary bypass grafting surgical products.
Cardiovascular also includes Care Management Services and
Cath Lab Managed Services (CLMS) within the Cardiac Rhythm &
Heart Failure division. Cardiovascular net sales for fiscal year
2021 were $10.8 billion, an increase of 3 percent as compared to
fiscal year 2020. Currency had a favorable impact on net sales for
fiscal year 2021 of $131 million. Cardiovascular net sales
increase for fiscal year 2021, as compared to fiscal year 2020,
was primarily due to the recovery of global procedural volumes
from the downturn experienced in the fourth quarter of fiscal
year 2020 resulting from the pandemic.
MEDTRONIC PLC 2021 Form 10-K 41
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
The charts below illustrate the percent of Cardiovascular net sales by division for fiscal years 2021 and 2020:
Fiscal Year 2021 Fiscal Year 2020
52%
22%
26%
CRHF
SHA
CPV
49%
24%
27%
CRHF
SHA
CPV
Cardiac Rhythm & Heart Failure (CRHF) net sales increased
9 percent in fiscal year 2021 as compared to fiscal year 2020.
The increase was led by Cardiac Rhythm Management and
Cardiac Ablation Solutions products, which included strong
growth from the Micra leadless pacing system, Cobalt and
Crome ICDs and CRT-Ds, TYRX antibacterial envelope, and Artic
Front Advance Cryoballons. Partially offsetting this growth were
declines in Mechanical Circulatory Support products driven by
slower recovery of procedure volumes and competitive
dynamics.
Structural Heart & Aortic (SHA) net sales were flat in fiscal year
2021 as compared to fiscal year 2020 as growth in transcatheter
aortic valve replacement (TAVR) nets sales were offset by net
sales declines within our Aortic and Cardiac Surgery businesses.
The growth experienced in TAVR was driven by continued
adoption of the Evolut Pro + valve. The declines experienced in
Aortic and Cardiac Surgery were a result of slower recovery of
procedure volumes as well our voluntary recall of the Valiant
Navion Thoracic Stent Graft System in the fourth quarter of
fiscal year 2021.
Coronary & Peripheral Vascular (CPV) net sales decreased
5 percent in fiscal year 2021 as compared to fiscal year 2020. The
decline was a result of the generally more deferrable nature of
peripheral and endovenous procedure categories as well as the
negative impact of the Chinese national tender on our drug-
eluting stent sales. The Chinese national tender went into effect
in January 2021 and resulted in significant price declines for drug-
eluting stents in China, which negatively impacted our Coronary
business. Partially offsetting these negative impacts was growth
in drug-coated balloons and peripheral embolization coils. Drug-
coated balloon growth was the result of strong adoption of the
IN.PACT AV drug-coated balloon driven by its pivotal data
published during the second quarter of fiscal year 2021.
In addition to the general impacts of COVID-19 on our Company
as described in the Executive Level Overview, looking ahead, we
expect Cardiovascular could be affected by the following:
Continued growth of our Micra transcatheter pacing system.
Micra AV received U.S. FDA approval and CE Mark approval in
January and April 2020, respectfully. Micra AV expands the
Micra target population from 15 percent to 45 percent of
pacemaker patients.
Continued acceptance and growth from the Azure XT and S
SureScan pacing systems. Azure pacemakers feature
Medtronic-exclusive BlueSync technology, which enables
automatic, secure wireless remote monitoring with increased
device longevity.
Acceptance and growth of the Cobalt and Crome portfolio of
ICDs and CRT-Ds. These devices received CE Mark approval
during the fourth quarter of fiscal year 2020 and U.S. FDA
approval during the first quarter of fiscal year 2021.
Continued acceptance and growth of the Claria MRI CRT-D
system with EffectivCRT Diagnostic and Effective CRT during
AF algorithm.
Acceptance and growth of the LINQ II cardiac monitor, which
received CE Mark in November 2019 and gained U.S. FDA
approval during the first quarter of fiscal year 2021. As of the
end of the fiscal year 2021, we are experiencing supply
constrains for the LINQ II cardiac monitor as we ramp our
wafer scale manufacturing.
Continued acceptance and growth of the CRT-P quadripolar
pacing system.
Continued growth, adoption, and utilization of the TYRX
Envelope for implantable devices driven by the favorable
results of the WRAP-IT clinical study. In the fourth quarter of
fiscal year 2020, we received 12-month shelf life extension for
our TYRX Envelope product.
Continued acceptance and market expansion of the Arctic
Front Advance Cryoballoon for treatment of atrial fibrillation.
We are pursuing a first line therapy designation from the U.S.
FDA for the Arctic Front Advance Cryoballoon’s treatment of
atrial fibrillation using the data of the STOP AF First clinical trial.
Continued acceptance and growth of the self-expanding
CoreValve Evolut transcatheter aortic valve replacement
platform into intermediate risk indication globally and for the
treatment of patients determined to be at low risk with
surgery. The Platform received both CE Mark for low risk and
bicuspid labeling indication in Europe during the first quarter of
fiscal year 2021. In August 2020, the U.S. FDA approved
revised commercial labeling for the platform that modified a
precaution for the treatment of patients at low risk.
Continued expansion and training of field support to increase
coverage in the U.S. centers performing transcatheter aortic
valve replacement procedures.
Continued acceptance and growth from Evolut PRO, which
provides industry-leading hemodynamics, reliable delivery,
and advanced sealing with an excellent safety profile, as well as
acceptance of our next generation Evolut Pro Plus TAVR
valve.
The negative impact of the Chinese national tender on drug-
eluting stent prices in China, that went into effect in January
2021, as well as provincial tenders in China on other Coronary
product categories.
42
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
Continued acceptance and growth from the VenaSeal Closure
System in the U.S. The VenaSeal Closure System is a unique
non-thermal solution to address superficial venous disease
that provides improved patient comfort, reduces the recovery
time, and eliminates the risk of thermal nerve injury.
Our voluntary recall of the Valiant Navion Thoracic Stent Graft
System and our ability to ramp production of our previous
generation product, the Valiant Captivia Thoracic Stent Graft
System and resume selling this product in markets globally.
We currently have limited Valiant Captivia inventory available
and plan to reach full production capacity in October 2021.
Our recent decision to stop the distribution and sale of the
Medtronic HVAD System in June 2021 in light of a growing
body of observational clinical comparisons indicating a lower
frequency of neurological adverse events and mortality with
another circulatory support device available to patients
compared to the HVAD system. The HVAD system and
associated accessory revenue was $141 million in fiscal year
2021. Medtronic is committed to serving the needs of the
approximately 4,000 patients currently implanted with our
HVAD system. We expect to record a non-cash, pre-tax
impairment of long-lived assets of $400 million to $500 million
in the quarter ending July 30, 2021 primarily related to
intangible assets. Management also expects to record a
charge related to customer support obligations, restructuring,
and other associated costs in the quarter ending July 30,
2021.
Our ability to successfully develop and obtain regulatory
approval of products within our pipeline, which include the
Symplicity Spyral Multi-Electrode Renal Denervation Catheter
for the treatment of hypertension through a one-time,
minimally invasive, catheter procedure, Pulse Field Ablation, a
novel energy source that is non-thermal, for the treatment of
atrial fibrillation, and transcatheter mitral and tricuspid therapy
products lead by our Intrepid system.
Medical Surgical
Medical Surgical’s products span the entire continuum of patient
care from diagnosis to recovery, with a focus on diseases of the
gastrointestinal tract, lungs, pelvic region, kidneys, obesity, and
preventable complications. The products include those for
advanced and general surgical products, surgical stapling
devices, vessel sealing instruments, wound closure,
electrosurgery products, hernia mechanical devices, mesh
implants, advanced ablation, interventional lung, ventilators,
airway products, renal care products, and sensors and monitors
for pulse oximetry, capnography, level of consciousness and
cerebral oximetry. Medical Surgical’s net sales for fiscal year
2021 were $8.7 billion, an increase of 5 percent as compared to
fiscal year 2020. Currency had a favorable impact on net sales of
$87 million for fiscal year 2021. Net sales growth was primarily
driven by the recovery in procedure volumes experienced from
the downturn experienced in the fourth quarter of fiscal year
2020 from the pandemic and increased demand for COVID-19
related diagnostics and therapies, particularly ventilator and
airway products, as compared to fiscal year 2020.
The charts below illustrate the percent of Medical Surgical net sales by division for fiscal years 2021 and 2020:
Fiscal Year 2021 Fiscal Year 2020
62%
38%
SI
RGR
66%
34%
SI
RGR
Surgical Innovations (SI) net sales for fiscal year 2021 decreased
1 percent as compared to fiscal year 2020, with declines
experienced across many product lines due to the deceleration
of surgical procedure recovery. The decline in surgical volumes,
particularly Bariatric, Colorectal, Hernia, and Thoracic
procedures, resulted in lower demand for Advanced Stapling
products and General Surgery products. This decline in demand
was partially offset by new product launches driving growth in
Advanced Energy.
Respiratory, Gastrointestinal, & Renal (RGR) net sales for fiscal
year 2021 increased 16 percent as compared to fiscal year 2020.
Net sales growth was primarily attributable to increased demand
for Respiratory Interventions products due to COVID-19, driven
by the Puritan Bennett high acuity ventilator portfolio.
In addition to the general impacts of COVID-19 on our Company
as described in the Executive Level Overview, looking ahead we
expect Medical Surgical could be affected by the following:
Continued acceptance and future growth of Open-to-MIS
techniques and tools supported by our efforts to transition
open surgery to MIS (minimally invasive surgery). The
Open-to-MIS initiative focuses on furthering our presence in
and working to optimize open surgery globally, while capturing
the market opportunity that exists in transitioning open
procedures to MIS, whether through traditional MIS, or
advanced technologies including robotics.
Continued acceptance and future growth of powered stapling
and energy platform, along with our ability to execute ongoing
strategies to develop, gain regulatory approval, and
commercialize new products including our surgical soft tissue
robotics platform.
MEDTRONIC PLC 2021 Form 10-K 43
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
Our ability to execute ongoing strategies in order to address
the competitive pressure of reprocessing of our vessel sealing
disposables and growth of surgical soft tissue robotics
procedures in the U.S.
Our ability to create markets and drive products and
procedures into emerging markets. We have high quality and
cost-effective surgical products designed for customers in
emerging markets such as the ValleyLab LS10 single channel
vessel sealing generator, which is compatible with our line of
LigaSure instruments and designed for simplified use and
affordability.
Continued acceptance and growth within the end stage renal
disease market. The population of patients treated for end
stage renal disease globally is expected to double over the
next decade.
Continued elevation of the standard of care for respiratory
compromise, a progressive condition impacting a patient’s
ability to breathe effectively, which leverages our market
leading MicroStream capnography technology.
Continued acceptance and growth in patient monitoring,
airway, and ventilation management. Key products in this area
include the Puritan Bennett 980 ventilator, Microstream
Capnography, Nellcor pulse oximetry system with OxiMax
technology, Shiley tracheostomy and endotracheal tubes, and
McGRATH MAC video laryngoscopes.
Continued and future acceptance of less invasive standards of
care in Gastrointestinal and Hepatology products, including
the areas of GI Diagnostic and Therapeutic product lines.
Recently launched products include the PillCam COLON
capsule endoscopy, the Barrx platform through ablation with
the Barrx 360 Express catheter, EndoFLIP imaging systems,
Bravo Calibration-free reflux testing, and the Emprint ablation
system with Thermosphere Technology, which maintains
predictable spherical ablation zones throughout procedures
reducing procedure time and cost.
Continued and future acceptance of Interventional Lung
Solutions. Products include our Illumisite navigation platform,
combined with our portfolio of biopsy tools including the
Arcpoint pulmonary needle, and to access lesions outside the
airway, the CrossCountry transbronchial access tool. This
comprehensive portfolio gives the power to display position
and access lung nodules in the periphery of the lungs, in a
minimally invasive approach to accessing difficult-to-reach
areas of the lung, which may aid in the diagnosis of lung
cancer.
Expanding the use of less invasive treatments and furthering
our commitment to improving options for women with
abnormal uterine bleeding. Our expanded and strengthened
surgical offerings are expected to complement our global
gynecology business.
Our ability to successfully develop and obtain regulatory
approval of products within our pipeline, which include our
PillCam Genius endoscopy module, a noninvasive process to
localize pre-cancerous lesions and our Hugo robotic assisted
surgery system, designed to help reduce unwanted variability,
improve patient outcomes, and, by extension, lower
per-procedure cost.
Neuroscience
Neuroscience’s products include various spinal implants, bone
graft substitutes, biologic products, image-guided surgery and
intra-operative imaging systems, robotic guidance systems used
in the robot-assisted spine procedures, and systems that
incorporate advanced energy surgical instruments.
Neuroscience’s products also focus on the treatment of
overactive bladder, urinary retention, fecal incontinence,
gastroparesis, as well as products to treat ear, nose, and throat
(ENT), and therapies to treat the diseases of the vasculature in
and around the brain, including coils, neurovascular stents and
flow diversion products. Neuroscience also manufactures
products related to implantable neurostimulation therapies and
drug delivery systems for the treatment of chronic pain,
movement disorders, and epilepsy. Neuroscience’s net sales for
fiscal year 2021 were $8.2 billion, an increase of 6 percent as
compared to fiscal year 2020. Currency had a favorable impact
on net sales for fiscal year 2021 of $75 million. Neuroscience’s
net sales growth was observed across all divisions and reflected
the recovery of global procedural volumes, particularly on
deferrable procedures, from the downturn experienced in the
fourth quarter of fiscal year 2020 as a result of the pandemic.
The graphs below illustrate the percent of Neuroscience net sales by division for fiscal years 2021 and 2020:
Fiscal Year 2021 Fiscal Year 2020
52%
20%
28%
CST
Specialty
NM
53%
19%
28%
CST
Specialty
NM
Cranial & Spinal Technologies (CST) net sales for fiscal year 2021
increased 5 percent as compared to fiscal year 2020. Growth
was experienced by both Enabling Technologies and Spine.
Enabling Technologies results, though still impacted by the
challenging environment for capital equipment due to
COVID-19, were driven by recovery on sales of the Midas Rex
MR8 high-speed drill system and the StealthStation S8
Navigation System. Spine net sales growth was driven by
recovery in procedural volumes in fiscal year 2021.
44
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
Specialty Therapies (Specialty) net sales for fiscal year 2021
increased 7 percent as compared to fiscal year 2020. Net sales
growth was primarily driven by strength in Pelvic Health and
Neurovascular. Pelvic Health saw continued recovery and growth
throughout the fiscal year, driven by the launch of the InterStim
Micro neurostimulator and SureScan MRI lead in the U.S.
Neurovascular’s growth continued to be driven by strength in
coils and aspiration catheters, as well as general strength in
emerging markets. This growth was partially offset by declines in
flow diversion products due to recent competitive entrants. ENT
experienced modest net sales growth due to the recovery of
deferrable procedure volumes.
Neuromodulation (NM) net sales for fiscal year 2021 increased
7 percent as compared to fiscal year 2020. Sales growth
occurred in both Pain Therapies and Brain Modulation and
reflected a recovery in procedural volumes. Net sales growth
was driven by strong adoption of the DTM (differential target
multiplexed) proprietary waveform in Pain Therapies, and the
Percept PC deep brain stimulation (DBS) device with BrainSense
technology in Brain Modulation.
In addition to the general impacts of COVID-19 on our Company
as described in the Executive Level Overview, looking ahead we
expect Neuroscience could be affected by the following:
Continued growth from Enabling Technologies StealthStation
and O-Arm Imaging Systems, Midas, and ENT Navigation and
Power Systems, as well as acceptance of the Stealth
Autoguide cranial robotic guidance platform.
Continued sales of Mazor robotic units and associated market
adoption of robot-assisted spine procedures, including the
Mazor X Stealth, our integrated robotics and navigation
platform.
Strengthening of our position in the spine titanium interbody
implant marketplace as a result of the June 2019 acquisition of
Titan Spine.
Continued adoption of our integrated solutions through the
Surgical Synergy strategy, which integrates our spinal implants
with enabling technologies such as imaging, navigation, power
instruments, nerve monitoring, and Mazor robotics.
Market acceptance and continued global adoption of
innovative new spine products and procedural solutions within
our CST business such as our Infinity OCT System and
Prestige LP cervical disc system.
Growth in the broader vertebral compression fracture (VCF)
and adjacent markets as we continue to pursue the
development of other therapies to treat more patients with
VCF, including continued success of both the Kyphon V
vertebroplasty system and the Osteocool RF Spinal Tumor
ablation system.
Continued acceptance and growth of our ENT and Pelvic
Health therapies within our Specialty Therapies division,
including our InterStim therapy with InterStim II and InterStim
Micro neurostimulators, which received CE mark approval in
January 2020 and U.S. FDA approval in August 2020, for the
treatment of the symptoms of overactive bladder, urinary
retention, and bowel incontinence, and capital equipment
sales of the Stealth Station ENT surgical navigation system
and intraoperative NIM nerve monitoring system.
Continued acceptance and growth of the Solitaire FR
revascularization device for treatment of acute ischemic
stroke and the Pipeline Embolization Devices, endovascular
treatments for large or giant wide-necked brain aneurysms.
Continued acceptance of our React Catheter and Riptide
aspiration system, along with our next-generation Solitaire
revascularization device.
Market acceptance and continued global adoption of our
Intellis spinal cord stimulator, DTM proprietary waveform,
Evolve workflow algorithm, and Snapshot reporting to treat
chronic pain in major markets around the world.
Continued acceptance and growth of our Percept PC DBS
device with BrainSense technology, which received CE Mark
approval in January 2020 and U.S. FDA approval in June 2020,
including its treatment of Parkinson’s Disease, epilepsy, and
other movement disorders.
Ongoing obligations under the U.S. FDA consent decree
entered in April 2015 relating to the SynchroMed drug infusion
system and the Neuromodulation quality system. The U.S.
FDA lifted its distribution requirements on our implantable
drug pump in October 2017 and its warning letter in November
2017.
Our ability to successfully develop and obtain regulatory
approval of the products within our pipeline, which include our
closed-loop Percept PC and RC devices with adaptive DBS
(aDBS) within Neuromodulation, as well as our hemorrhagic
stroke intrasaccular device within Specialty Therapies, and our
next-generation spine enabling technologies within CST.
Diabetes
Diabetes’ products include insulin pumps, continuous glucose
monitoring (CGM) systems, insulin pump consumables, and
smart insulin pen systems. Diabetes’ sales for fiscal year 2021
were $2.4 billion, an increase of 2 percent as compared to fiscal
year 2020. Currency had a favorable impact on net sales for fiscal
year 2021 of $37 million. Diabetes’ net sales increases for fiscal
year 2021 were primarily attributable to growth in the MiniMed
780G insulin pump system and integrated CGM in the
international markets. This growth was partially offset by
declines in the U.S. due to new patient start delays and continued
competitive pressures.
In addition to the general impacts of COVID-19 on our Company
as described in the Executive Level Overview, looking ahead we
expect Diabetes could be affected by the following:
Patient demand for the MiniMed 770G insulin pump system,
which received U.S. FDA approval in August 2020 and launched
in November 2020. The system is powered by SmartGuard
technology, as featured in the MiniMed 670G system, with the
added benefits of smartphone connectivity and an expanded
age indication to children as young as age two.
Continued future growth internationally for the MiniMed 780G
system. The MiniMed 780G system was approved in the E.U. in
June 2020 and launched in over 30 countries on four
continents outside the U.S., primarily in Europe, starting in
October 2020. The global adoption of sensor-augmented
insulin pump systems has resulted in strong sensor
attachment rates.
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Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
Continued acceptance and growth of the Guardian Connect
CGM system, which displays glucose information directly to a
smartphone. During the first quarter of fiscal year 2021, we
introduced the Guardian Connect system for Android devices
to ensure patients have access to their glucose levels
seamlessly and discretely. The Guardian Connect CGM
system is available on Apple iOS and Android devices.
Strengthening our position in the diabetes market as a result
of the September 10, 2020 acquisition of Companion Medical.
Companion Medical offers a U.S. FDA cleared InPen smart pen
system that combines the freedom of a reusable Bluetooth
pen with the intelligence of an intuitive mobile application that
helps users administer the appropriate insulin dose. During the
third quarter of fiscal year 2021, we integrated our CGM data
into the Companion Medical InPen Application, which allows
users to have their CGM readings in real-time alongside insulin
dose information, all in one view.
Continued pump and CGM competition in an expanding global
market.
Changes in medical reimbursement policies and programs,
along with additional payor coverage on insulin pumps.
Our ability to successfully develop and obtain regulatory
approval of the products within our pipeline, which include our
adult and pediatric MiniMed 780G and the Guardian 4 sensor,
which have been submitted to the U.S. FDA. These
technologies feature our next-generation algorithms by
further automating insulin delivery.
COSTS AND EXPENSES
The following is a summary of cost of products sold, research and development, and selling, general, and administrative expenses as a
percent of net sales:
Fiscal Year 2021 Fiscal Year 2020
Cost of products sold
Selling, general, & administrative
Research & development
34.8%
33.7%
8.3%
35.0%
8.1%
32.6%
Cost of Products Sold
Cost of products sold for fiscal years 2021 and 2020 was
$10.5 billion and $9.4 billion, respectively. The increase in cost of
products sold as a percentage of net sales in fiscal year 2021, as
compared to fiscal year 2020, was largely due to increased
expenses as a result of a full fiscal year impact of COVID-19,
primarily due to period expensing of some of our fixed overhead
costs due to idle capacity at certain manufacturing facilities and
increases in reserves for excess and obsolete inventory, as well
as charges associated with recent field corrective actions. Going
forward, we will continue to focus on reducing our costs of
production through supplier management, manufacturing
improvements, and optimizing our manufacturing network.
Research and Development Expense
We remain committed to accelerating the development of
meaningful innovations to deliver better patient outcomes at
appropriate costs that lead to enhanced quality of life and may
be validated by clinical and economic evidence. We are also
focused on expanding access to quality healthcare.
In fiscal year 2021, we entered into arrangements with third
parties to fund the development of certain technologies in our
Diabetes segment. As there is a substantive and genuine
transfer of risk to the third parties, the development funding
provided is recognized as an obligation to perform contractual
services, and therefore is recorded as income in other operating
expense, net in the consolidated statements of income in the
period the corresponding research and development expenses
are incurred. If the technologies receive regulatory approval and
are successfully commercialized, we will pay royalties to the third
parties. During fiscal year 2021, no projects were significant,
either individually or in aggregate, to our consolidated results.
Selling, General, and Administrative Expense
Our goal is to continue to leverage selling, general, and
administrative expense initiatives. Selling, general, and
administrative expense primarily consists of salaries and wages,
other administrative costs, such as professional fees and
marketing expenses, and certain acquisition and restructuring
expenses.
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Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
Selling, general, and administrative expense for fiscal years 2021
and 2020 was $10.1 billion. The decrease in selling, general, and
administrative expense as a percentage of net sales in fiscal year
2021, as compared to 2020, was primarily due to net sales
growth, coupled with reduced travel and discretionary spending
due to the pandemic, offset by higher annual incentive accruals
and increased restructuring and associated costs. Selling,
general, and administrative expense in fiscal year 2021 includes
$196 million of restructuring and associated costs, as compared
to $168 million in fiscal year 2020. Additionally, for fiscal year
2020, selling, general, and administrative expense includes
$103 million of acquisition-related costs, as compared to
$3 million for fiscal year 2021.
The following is a summary of other costs and expenses:
Fiscal Year
(in millions) 2021 2020
Amortization of intangible assets $ 1,783 $ 1,756
Restructuring charges, net 293 118
Certain litigation charges 118 313
Other operating expense, net 315 71
Other non-operating income, net (336) (356)
Interest expense 925 1,092
Amortization of Intangible Assets
Amortization of intangible assets includes the amortization
expense of our definite-lived intangible assets, consisting of
purchased patents, trademarks, tradenames, customer
relationships, purchased technology, and other intangible assets.
Restructuring Charges, Net
Enterprise Excellence
In the third quarter of fiscal year 2018, we announced a multi-
year global Enterprise Excellence Program designed to drive
long-term business growth and sustainable efficiency. The
Enterprise Excellence Program is expected to further leverage
our global size and scale as well as enhance the customer and
employee experience.
The Enterprise Excellence Program is focused on three
objectives:
Global Operations – integrating and enhancing global
manufacturing and supply processes, systems and site
presence to improve quality, delivery cost and cash flow
Functional Optimization – enhancing and leveraging global
operating models and systems across several enabling
functions to improve productivity and employee experience
Commercial Optimization – optimizing certain processes,
systems and models to improve productivity and the
customer experience
The Enterprise Excellence Program is designed to drive
operating margin improvement as well as fund investment in
strategic growth initiatives, with expected gross savings of more
than $3.0 billion from cost reductions and leverage of our fixed
infrastructure by the end of fiscal year 2022. Approximately
$500 million to $700 million of gross annual savings are expected
to be achieved through the end of fiscal year 2022.
The Enterprise Excellence Program is expected to result in
pre-tax restructuring charges of approximately $1.6 billion to
$1.8 billion, the vast majority of which are expected to be
incurred by the end of fiscal year 2022 and result in cash outlays
to be substantially complete by the end of fiscal year 2023.
Approximately 40 percent of estimated charges are related to
employee termination benefits. The remaining charges are costs
associated with the restructuring program, such as salaries and
benefits for employees supporting the program, including
program management and transition teams, and strategic and
operational consulting services related to the three objectives of
the program discussed above. We expect these costs to be
recognized within restructuring charges, net, cost of products
sold, and selling, general and administrative expense in the
consolidated statements of income.
During fiscal year 2021, we recognized net charges of
$349 million, including $52 million recognized within
restructuring charges, net in the consolidated statements of
income which were primarily comprised of employee termination
benefits. For fiscal year 2021, charges also included costs
incurred as a direct result of the restructuring program, such as
salaries for employees supporting the program and consulting
expenses, including $128 million recognized within cost of
products sold and $169 million recognized within selling, general
and administrative expense in the consolidated statements of
income.
During fiscal year 2020, we recognized net charges of
$441 million, including $118 million recognized within
restructuring charges, net in the consolidated statements of
income primarily comprised of employee termination benefits.
For fiscal year 2020, charges also included costs incurred as a
direct result of the restructuring program, such as salaries for
employees supporting the program and consulting expenses,
including $149 million recognized within cost of products sold
and $165 million recognized within selling, general and
administrative expense in the consolidated statements of
income.
Simplification
In the first quarter of fiscal year 2021, we initiated our
Simplification restructuring program, designed to make the
Company a more nimble and competitive organization focused
on accelerating innovation, enhancing the customer experience,
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Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
driving revenue growth, and winning market share, while also
more efficiently and effectively leveraging our enterprise scale.
Under the oversight of the portfolio leaders, this new operating
model, which became fully operational the beginning of the
fourth quarter of fiscal year 2021, will simplify our organizational
structure and accelerate decision-making and execution.
Primary activities of the restructuring program will include
reorganizing our business into a portfolio-level structure,
including the creation of highly focused, accountable and
empowered Operating Units (OUs), consolidating operations at
the enterprise level, establishing Technology Development
Centers in areas where we have deep core technology
competencies to be leveraged by multiple OUs, and forming
dedicated sales organizations that leverage our scale but move
with the same agility as our smaller, local competitors.
The Simplification program designed to streamline our operating
model, improve competitiveness, and enhance the customer
and employee experience will result in substantial reduction in
selling, general, and administrative expenses, the majority of
which are expected to be achieved through the end of fiscal year
2022. Annual savings of approximately $450 million to
$475 million are expected to be realized by the various
components of the Simplification program.
We estimate that, in connection with the Simplification
restructuring program, we will recognize pre-tax exit and
disposal costs and other costs across all segments of
approximately $400 million to $450 million, the majority of which
are expected to be incurred by the end of fiscal year 2022.
Approximately three quarters of the estimated charges are
related to employee termination benefits. The remaining
charges are costs associated with the restructuring program,
such as salaries for employees supporting the program and
consulting expenses to execute the reorganization of our
business into a portfolio-like structure as discussed above.
These charges are recognized within restructuring charges, net
and selling, general, and administrative expense in the
consolidated statements of income.
During fiscal year 2021, we recognized net charges of $268 million,
including $241 million within restructuring charges, net in the
consolidated statements of income. For fiscal year 2021, charges
included $97 million of incremental defined benefit pension and
post-retirement related expenses for employees that accepted
voluntary early retirement packages within restructuring charges,
net in the consolidated statements of income. For fiscal year
2021, charges also included costs incurred as a direct result of the
restructuring program, such as salaries for employees supporting
the program and consulting expenses, including $27 million
recognized within selling, general, and administrative expense in
the consolidated statements of income.
For additional information, see Note 4 to the consolidated
financial statements in “Item 8. Financial Statements and
Supplementary Data” in this Annual Report on Form 10-K.
Certain Litigation Charges
We classify litigation charges and gains related to significant legal
matters as certain litigation charges. For additional information,
refer to Note 18 of the consolidated financial statements in
“Item 8. Financial Statements and Supplementary Data” in this
Annual Report on Form 10-K.
Other Operating Expense, Net
Other operating expense, net primarily includes royalty income
and expense, currency remeasurement and derivative gains and
losses, Puerto Rico excise taxes, changes in fair value of
contingent consideration, changes in amounts accrued for
certain contingent liabilities for a recent acquisition, a
commitment to the Medtronic Foundation, charges associated
with business exits, impairment charges, in-process research
and development (IPR&D) charges, and income from funded
research and development arrangements.
The increase in other operating expense, net from fiscal year
2020 to 2021 was primarily driven by our remeasurement and
hedging programs, which, combined, resulted in a loss of
$47 million for fiscal year 2021 as compared to a gain of
$295 million for fiscal year 2020. Additionally, for fiscal year 2021,
other operating expense, net includes a $132 million gain related
to amounts accrued for certain contingent liabilities for a recent
acquisition and impairment charges of $76 million related to the
abandonment of certain intangible assets. Also contributing to
the increase were changes in fair value of contingent
consideration resulting in a loss of $36 million for fiscal year 2021
as compared to a gain of $33 million for fiscal year 2020. For
fiscal year 2020, other operating expense, net includes an
$80 million charge associated with a commitment to the
Medtronic Foundation and charges of $52 million associated
with the exit of businesses.
Other Non-Operating Income, Net
Other non-operating income, net includes the non-service
components of net periodic pension and postretirement benefit
cost, investment gains and losses, and interest income.
The decrease in other non-operating income, net from fiscal
year 2020 to 2021 was primarily attributable to the decrease in
interest income as a result of the lower interest rate
environment. Interest income was $192 million and $300 million
for fiscal years 2021 and 2020, respectively. This decrease was
partially offset by an increase in gains recognized on minority
investments. Gains on minority investments were $61 million for
fiscal year 2021 as compared to losses of $19 million for fiscal
year 2020.
Interest Expense
Interest expense includes interest incurred on our outstanding
borrowings, amortization of debt issuance costs and debt
premiums or discounts, amortization of gains or losses on
terminated or de-designated interest rate derivative
instruments, and charges recognized in connection with the
tender and early redemption of senior notes. The decrease in
interest expense from fiscal year 2020 to 2021 was primarily due
to a decrease in charges related to debt tender and redemption
transactions, which were $308 million for fiscal year 2021, as
compared to $413 million for fiscal year 2020. Also contributing
to the decrease was a decrease in the weighted-average
interest rate of outstanding debt obligations due to the
aforementioned debt issuance and tender transactions. Refer to
the “Debt and Capital” section of this Management’s Discussion
and Analysis for additional information on the debt issuances,
tenders, and early redemptions.
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INCOME TAXES
Fiscal Year
(in millions) 2021 2020
Income tax provision (benefit) $ 265 $ (751)
Income before income taxes 3,895 4,055
Effective tax rate 6.8% (18.5)%
Non-GAAP income tax provision $ 809 $ 1,038
Non-GAAP income before income taxes 6,835 7,261
Non-GAAP Nominal Tax Rate 11.8% 14.3%
Difference between the effective tax rate and Non-GAAP Nominal Tax Rate 5.0% 32.8%
Many of the countries we operate in have statutory tax rates
lower than our U.S. statutory rate, thereby resulting in an overall
effective tax rate less than the U.S. statutory rate of 21.0 percent.
A significant portion of our earnings are generated from
operations in Puerto Rico, Switzerland, and Ireland. The statutory
tax rates for these jurisdictions range from 12.5 percent to
43.75 percent. Our earnings in Puerto Rico are subject to certain
tax incentive grants which provide for tax rates lower than the
country’s statutory tax rates. Unless our tax incentive grants are
extended, they will expire between fiscal years 2022 and 2030.
The tax incentive grants, which expired during fiscal year 2021, did
not have a material impact on our financial results. See Note 13 to
the consolidated financial statements in “Item 8. Financial
Statements and Supplementary Data” in this Annual Report on
Form 10-K for additional information.
Our effective tax rate for fiscal year 2021 was 6.8 percent, as
compared to (18.5) percent in fiscal year 2020. The increase in
the effective tax rate was primarily due to the impacts from
certain tax adjustments and year-over-year changes in
operational results by jurisdiction.
Our Non-GAAP Nominal Tax Rate for fiscal year 2021 was
11.8 percent, as compared to 14.3 percent in fiscal year 2020.
The decrease in our Non-GAAP Nominal Tax Rate for fiscal year
2021 as compared to fiscal year 2020 was primarily due to the
year-over-year changes in operational results by jurisdiction.
During fiscal year 2021, we recognized $51 million of operational tax
benefits. The operational tax benefits included a $46 million benefit
from excess tax benefits associated with stock-based compensation
and a $5 million net benefit associated with the resolution of certain
income tax audits, finalization of certain tax returns, changes to
uncertain tax position reserves, legal entity reorganizations, and
changes to certain deferred income tax balances.
During fiscal year 2020, we recognized $138 million of operational
tax benefits. The operational tax benefits included a $63 million
benefit from excess tax benefits associated with stock-based
compensation and a $75 million net benefit associated with the
resolution of certain income tax audits, finalization of certain tax
returns, changes to uncertain tax position reserves, and changes
to certain deferred income tax balances.
An increase in our Non-GAAP Nominal Tax Rate of one percent
would result in an additional income tax provision for fiscal years
2021 and 2020 of approximately $68 million and $73 million,
respectively.
Certain Tax Adjustments
During fiscal year 2021, the net benefit from certain tax
adjustments of $41 million, recognized in income tax provision
(benefit) in the consolidated statement of income, included the
following:
A net benefit of $106 million associated with the resolution of
an audit at the IRS Appellate level for fiscal years 2012, 2013,
and 2014. The issues resolved relate to the utilization of certain
net operating losses and the allocation of income between
Medtronic, Inc. and its wholly owned subsidiary operating in
Puerto Rico for businesses that are not the subject of the U.S.
Tax Court Case for fiscal years 2005 and 2006.
A net cost of $73 million related to a tax basis adjustment of
previously established deferred tax assets from intercompany
intellectual property transactions. The cumulative amount of
deferred tax benefit previously recognized from intercompany
intellectual property transactions and recorded as Certain Tax
Adjustments is $1.5 billion. The corresponding deferred tax
assets will be amortized over a period of approximately 20 years.
A cost of $50 million associated with the amortization of the
previously established deferred tax assets from intercompany
intellectual property transactions.
A net cost of $25 million associated with an internal
restructuring and intercompany sale of assets.
A benefit of $83 million related to the capitalization of certain
research and development costs for U.S. income tax purposes
and the establishment of a deferred tax asset at the U.S.
federal statutory tax rate.
During fiscal year 2020, the net benefit from certain tax
adjustments of $1.2 billion, recognized in income tax provision
(benefit) in the consolidated statement of income, included the
following:
A net benefit of $63 million related to the finalization of certain
state tax impacts from U.S. Tax Reform, and the issuance of
certain final U.S. Treasury Regulations associated with U.S. Tax
Reform. The primary impact of these regulations resulted in
the Company re-establishing its permanently reinvested
assertion on certain foreign earnings and reversing the
previously accrued tax liability. This benefit was partially offset
by additional tax associated with a previously executed internal
reorganization of certain foreign subsidiaries.
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A benefit of $252 million related to tax legislative changes in
Switzerland, which abolished certain preferential tax regimes
the Company benefited from and replaced them with a new
set of internationally accepted measures. The legislation
provided for higher effective tax rates but allowed for a
transitional period whereby an amortizable asset was created
for Swiss federal income tax purposes that will be amortized
and deducted over a 10-year period.
A benefit of $658 million related to the release of a valuation
allowance previously recorded against certain net operating
losses. Luxembourg enacted tax legislation during the year
requiring the company to reassess the realizability of certain
net operating losses. The Company evaluated both the
positive and negative evidence and released valuation
allowance equal to the expected benefit from the utilization of
certain net operating losses in connection with a planned
intercompany sale of intellectual property.
A net benefit of $269 million associated with the intercompany
sale of intellectual property and the establishment of a
deferred tax asset.
Certain tax adjustments will affect the comparability of our
operating results between periods. Therefore, we consider
these Non-GAAP Adjustments. Refer to the “Executive Level
Overview” section of this Management’s Discussion and Analysis
for further discussion of these adjustments.
LIQUIDITY AND CAPITAL RESOURCES
We are currently in a strong financial position, despite the impact
COVID-19 had on our business and financial results during fiscal
years 2021 and 2020. We believe our balance sheet and liquidity
provide us with flexibility, and our cash, cash equivalents, and
current investments, along with our credit facility and related
commercial paper programs will satisfy our foreseeable
operating needs.
Our liquidity and capital structure are evaluated regularly within
the context of our annual operating and strategic planning
processes. We consider the liquidity necessary to fund our
operations, which includes working capital needs, investments in
research and development, property, plant, and equipment, and
other operating costs. We also consider capital allocation
alternatives that balance returning value to shareholders
through dividends and share repurchases, satisfying maturing
debt, and acquiring businesses and technology.
Summary of Cash Flows
The following is a summary of cash provided by (used in) operating, investing, and financing activities, the effect of exchange rate
changes on cash and cash equivalents, and the net change in cash and cash equivalents:
Fiscal Year
(in millions) 2021 2020
Cash provided by (used in):
Operating activities $ 6,240 $ 7,234
Investing activities (2,866) (3,203)
Financing activities (4,136) (4,198)
Effect of exchange rate changes on cash and cash equivalents 215 (86)
Net change in cash and cash equivalents $ (547) $ (253)
Operating Activities
The $994 million decrease in net cash provided was primarily
driven by a decrease in cash collected from customers and an
increase in cash paid for income taxes, partially offset by a
decrease in cash paid to employees, a decrease in payments
made for employer taxes, and a decrease in retirement benefit
plan contributions. The decrease in cash collected from
customers was primarily related to COVID-19 driving decreased
sales in the fourth quarter of fiscal year 2020 and first quarter of
fiscal year 2021, when compared to the prior fiscal year. The
increase in cash paid for income taxes was primarily due to
increased estimated federal tax payments and tax payments
associated with IRS audit settlements in fiscal year 2021. Cash
paid to employees decreased due to lower annual incentive plan
payouts compared the prior fiscal year. Payments made for
employer taxes decreased due to the deferral of payment on the
Company’s share of Social Security taxes allowed by the CARES
Act in the current fiscal year. For information on retirement
benefit plan contributions, refer to Note 15 to the consolidated
financial statements in “Item 8. Financial Statements and
Supplementary Data” in this Annual Report on Form 10-K.
Investing Activities
The $337 million decrease in net cash used was primarily
attributable to a decrease in net purchases of investments of
$1.0 billion, partially offset by a decrease in cash paid for
acquisitions of $506 million as compared to fiscal year 2020.
50 MEDTRONIC PLC 2021 Form 10-K
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Financing Activities
The $62 million decrease in net cash used included a number of
largely offsetting items. Contributing to the decrease in cash
used was a decrease in share repurchases of $674 million.
Partially offsetting this decrease was a net decrease in short-
term borrowings of $294 million and an increase in dividends paid
to shareholders of $226 million. For fiscal year 2021, financing
cash flows were impacted by the Mizuho Bank term loan under
which we borrowed ¥300 billion in the first quarter of fiscal year
2021, which was subsequently repaid in the fourth quarter of
fiscal year 2021. Fiscal year 2021 financing cash flows were also
impacted by the issuance of $7.2 billion of Euro-denominated
senior notes offset by the early redemption of $6.0 billion of
senior notes for $6.3 billion of total consideration, and
repayment of an additional $911 million of Euro-denominated
senior notes. For comparison, financing cash flows for fiscal year
2020 reflect the issuance of $5.6 billion of Euro-denominated
senior notes, offset by the tender of $5.2 billion of senior notes
for $5.6 billion of total consideration. We also repaid $500 million
of senior notes at maturity during the fourth quarter of fiscal year
2020. For more information on the aforementioned Mizuho Bank
term loan, and issuances and redemptions of senior notes, refer
to the Debt and Capital section.
Debt and Capital
Our capital structure consists of equity and interest-bearing
debt. We primarily utilize unsecured senior debt obligations to
meet our financing needs and, to a lesser extent, bank
borrowings. From time to time, we may repurchase our
outstanding debt obligations in the open market or through
privately negotiated transactions.
Total debt at April 30, 2021 was $26.4 billion, as compared to
$24.8 billion at April 24, 2020. The increase in total debt was
primarily driven by fluctuations in exchange rates as it pertains to
our Euro-denominated senior notes and, to a lesser extent, the
net impact of the issuance and redemption of senior notes, both
of which are described below.
In September 2020, we issued six tranches of Euro-
denominated senior notes with an aggregate principal of
6.3 billion, with maturities ranging from fiscal year 2023 to fiscal
year 2051, resulting in cash proceeds of approximately
$7.2 billion, net of discounts and issuance costs. The Euro-
denominated debt is designated as a net investment hedge of
certain of our European operations. We used the net proceeds
of the offering to fund the early redemption of $6.0 billion of
senior notes for $6.3 billion of total consideration in October
2020. Additionally, we used the proceeds to repay our
750 million floating rate senior notes at maturity in March 2021.
We recognized a loss on debt extinguishment of $308 million in
fiscal year 2021, which primarily included cash premiums and
accelerated amortization of deferred financing costs and debt
discounts and premiums. The loss on debt extinguishment was
recognized in interest expense in the consolidated statements
of income.
In May 2020, we entered into an unsecured term loan agreement
with Mizuho Bank, Ltd. for an aggregate principal amount of up to
¥300 billion, or approximately $2.8 billion, with a term of six
months and the option to extend for an additional six months.
On May 13, 2020, Medtronic Luxco borrowed the entire amount
of the term loan under the Loan Agreement. The proceeds of
the loan were used for general corporate purposes. The
Japanese Yen denominated debt was designated as a net
investment hedge of certain of our Japanese operations. On
November 12, 2020, we exercised our option to extend the term
of the loan for an additional six months. During the fourth quarter
of fiscal year 2021, we de-designated the Yen denominated debt
as a net investment hedge and repaid the term loan in full,
including interest.
We repurchase our ordinary shares from time to time as part of
our focus on returning value to our shareholders. In March 2019,
the Company’s Board of Directors authorized the repurchase of
$6.0 billion of the Company’s ordinary shares. There is no
specific time period associated with these repurchase
authorizations. During fiscal years 2021 and 2020, we
repurchased a total of 4 million and 12 million shares,
respectively, under these programs at an average price of
$126.80 and $106.22, respectively. At April 30, 2021, we had
approximately $5.4 billion remaining under the share repurchase
programs authorized by our Board of Directors.
For more information on credit arrangements, see Note 6 of the
consolidated financial statements in “Item 8. Financial
Statements and Supplementary Data” in this Annual Report on
Form 10-K.
Liquidity
Our liquidity sources at April 30, 2021 include $3.6 billion of cash
and cash equivalents and $7.2 billion of current investments.
Additionally, we maintain commercial paper programs (no
commercial paper outstanding at April 30, 2021) and a Credit
Facility.
Our investments primarily include available-for-sale debt
securities, including U.S. and non-U.S. government and agency
securities, corporate debt securities, mortgage-backed
securities, and other asset-backed securities. See Note 5 to the
consolidated financial statements in “Item 8. Financial
Statements and Supplementary Data” in this Annual Report on
Form 10-K for additional information on our investments.
We maintain multicurrency commercial paper programs for
short-term financing, which allows us to issue unsecured
commercial paper notes on a private placement basis up to a
maximum aggregate amount outstanding at any time of
$3.5 billion. At both April 30, 2021 and April 24, 2020, we had no
commercial paper outstanding. The issuance of commercial
paper reduces the amount of credit available under our existing
line of credit, as explained below.
We also have a $3.5 billion five-year syndicated credit facility
(Credit Facility), which expires in December 2025. The Credit
Facility provides backup funding for the commercial paper
programs and may also be used for general corporate purposes.
The Credit Facility provides us with the ability to increase our
borrowing capacity by an additional $1.0 billion at any time during
the term of the agreement. At each anniversary date of the
Credit Facility, but not more than twice prior to the maturity date,
we could also request a one-year extension of the maturity date.
MEDTRONIC PLC 2021 Form 10-K 51
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
At April 30, 2021 and April 24, 2020, no amounts were
outstanding under the Credit Facility.
Interest rates on advances of our Credit Facility are determined
by a pricing matrix based on our long-term debt ratings assigned
by Standard & Poor’s Rating Services (S&P) and Moody’s Investor
Service (Moody’s). Facility fees are payable on the Credit Facility
and are determined in the same manner as the interest rates. We
are in compliance with all covenants related to the Credit Facility.
The following table is a summary of our S&P and Moody’s long-term debt ratings and short-term debt ratings:
Agency Rating
(1)
April 30, 2021 April 24, 2020
Standard & Poor’s Ratings Services
Long-term debt AA
Short-term debt A-1 A-1
Moody’s Investors Service
Long-term debt A3 A3
Short-term debt P-2 P-2
(1) Agency ratings are subject to change, and there is no assurance that an agency will continue to provide ratings and/or maintain its current ratings.A
security rating is not a recommendation to buy, sell or hold securities, and may be subject to revision or withdrawal at any time by the rating agency,
and each rating should be evaluated independently of any other rating.
S&P and Moody’s long-term debt ratings and short-term debt
ratings at April 30, 2021 were unchanged as compared to the
ratings at April 24, 2020. We do not expect the S&P and Moody’s
ratings to have a significant impact on our liquidity or future
flexibility to access additional liquidity given our balance sheet,
Credit Facility, and related commercial paper programs.
Contractual Obligations and Cash
Requirements
We have future contractual obligations and other minimum
commercial commitments that are entered into in the normal
course of business, some of which are recorded in our
consolidated balance sheet. We believe our off-balance sheet
arrangements do not have a material current or anticipated
future effect on our consolidated earnings, financial position,
and/or cash flows.
Presented below is a summary of our off-balance sheet contractual obligations and other minimum commercial commitments at
April 30, 2021, as well as long-term contractual obligations reflected in the balance sheet at April 30, 2021.
Maturity by Fiscal Year
(in millions) Total 2022 2023 2024 2025 2026 Thereafter
Contractual obligations related to off-balance sheet
arrangements:
Commitments to fund minority investments, milestone
payments, and royalty obligations
(1)
$ 354 $ 157 $ 72 $ 47 $ 22 $ 19 $ 36
Interest payments
(2)
7,729 489 487 480 481 414 5,377
Other
(3)
1,038 550 232 103 42 29 82
Contractual obligations reflected in the balance sheet
(4)
:
Debt obligations
(5)
$ 26,588 $ 11 $ 4,237 $ 6 $ 1,895 $ 2,423 $ 18,016
Operating leases 1,090 223 166 147 119 97 338
Contingent consideration
(6)
270 78 120 33 34 4
Tax obligations
(7)
1,672 176 176 330 440 550
(1) Includes commitments related to the funding of minority investments, estimated milestone payments, and royalty obligations. While it is not certain
if and/or when payments will be made, the maturity dates included in the table reflect our best estimates.
(2) Includes the contractual interest payments on our outstanding debt and excludes the impacts of debt premium and discount amortization. See
Note 6 to the consolidated financial statements in “Item 8. Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for
additional information on our debt agreements.
(3) Includes inventory purchase commitments, research and development, and other arrangements that are legally binding and specify minimum
purchase quantities or spending amounts. These purchase commitments do not exceed our projected requirements and are in the normal course
of business. Excludes open purchase orders with a remaining term of less than one year.
(4) Excludes defined benefit plan obligations, guarantee obligations, uncertain tax positions, non-current tax liabilities, and litigation settlements for
which we cannot make a reliable estimate of the period of cash settlement. For further information, see Notes 13, 15, and 18 to the consolidated
financial statements in “Item 8. Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for further information.
52 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
(5) Includes the current and non-current portion of our Senior Notes and bank borrowings. Excludes debt premium and discount, unamortized gains
from terminated interest rate swap agreements, and commercial paper. See Notes 6 and 7 to the consolidated financial statements in “Item 8.
Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information on our debt agreements and interest
rate swap agreements, respectively.
(6) Includes the fair value of our current and non-current portions of contingent consideration. While it is not certain if and/or when payments will be
made, the maturity dates included in this table reflect our best estimates.
(7) Represents the tax obligations associated with the transition tax that resulted from U.S. Tax Reform. The transition tax will be paid over an eight-
year period and will not accrue interest. See Note 13 to the consolidated financial statements in “Item 8. Financial Statements and Supplementary
Data” in this Annual Report on Form 10-K for further information.
In the normal course of business, we periodically enter into
agreements that require us to indemnify customers or suppliers
for specific risks, such as claims for injury or property damage
arising as a result of our products or the negligence of our
personnel or claims alleging that our products infringe third-
party patents or other intellectual property. Our maximum
exposure under these indemnification provisions is unable to be
estimated, and we have not accrued any liabilities within our
consolidated financial statements or included any
indemnification provisions in the table above. Historically, we
have not experienced significant losses on these types of
indemnification agreements.
Note 18 to the consolidated financial statements in “Item 8.
Financial Statements and Supplementary Data” in this Annual
Report on Form 10-K provides information regarding amounts
we have accrued related to legal matters. In accordance with U.S.
GAAP, we record a liability in our consolidated financial
statements for these matters when a loss is known or
considered probable and the amount can be reasonably
estimated. Actual settlements may be different than estimated
and could have a material effect on our consolidated earnings,
financial position, and/or cash flows.
We record tax liabilities in our consolidated financial statements
for amounts that we expect to repatriate from subsidiaries (to
the extent the repatriation would be subject to tax); however, no
tax liabilities are recorded for amounts we consider to be
permanently reinvested. We expect to have access to the
majority of our cash flows in the future. In addition, we continue
to evaluate our legal entity structure supporting our business
operations, and to the extent such evaluation results in a change
to our overall business structure, we may be required to accrue
for additional tax obligations.
Beyond the contractual obligations and other minimum
commercial commitments outlined above, we have recurring
cash requirements arising from the normal operation of our
business that include capital expenditures, research and
developments costs, and other operational costs.
We believe our balance sheet and liquidity provide us with
flexibility, and our cash, cash equivalents, current investments,
Credit Facility and related commercial paper programs as well as
our ability to generate operating cash flows will satisfy our
current and future contractual obligations and cash
requirements. We regularly review our capital needs and
consider various investing and financing alternatives to support
our requirements.
ACQUISITIONS
Information regarding acquisitions is included in Notes 3 to the
consolidated financial statements in “Item 8. Financial
Statements and Supplementary Data” in this Annual Report on
Form 10-K.
CRITICAL ACCOUNTING ESTIMATES
We have used various accounting policies to prepare the
consolidated financial statements in accordance with U.S. GAAP.
Our significant accounting policies are disclosed in Note 1 to the
consolidated financial statements in “Item 8. Financial
Statements and Supplementary Data” in this Annual Report on
Form 10-K.
The preparation of the consolidated financial statements, in
conformity with U.S. GAAP, requires us to use judgment in
making estimates and assumptions that affect the reported
amounts of assets, liabilities, revenues, and expenses. These
estimates reflect our best judgment about economic and
market conditions and the potential effects on the valuation
and/or carrying value of assets and liabilities based upon relevant
information available. We base our estimates on historical
experience and on various assumptions that are believed to be
reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying values of
assets and liabilities that are not readily apparent from other
sources.
Our critical accounting estimates include the following:
Litigation Contingencies
We are involved in a number of legal actions involving product
liability, intellectual property and commercial disputes,
shareholder related matters, environmental proceedings, tax
disputes, and governmental proceedings and investigations. The
outcomes of these legal actions are not completely within our
control and may not be known for prolonged periods of time. In
some actions, the enforcement agencies or private claimants
seek damages, as well as other civil or criminal remedies
(including injunctions barring the sale of products that are the
subject of the proceeding), that could require significant
expenditures or result in lost revenues or limit our ability to
conduct business in the applicable jurisdictions. Estimating
probable losses from our litigation and governmental
proceedings is inherently difficult, particularly when the matters
are in early procedural stages, with incomplete scientific facts or
legal discovery; involve unsubstantiated or indeterminate claims
for damages; potentially involve penalties, fines, or punitive
MEDTRONIC PLC 2021 Form 10-K 53
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
damages; or could result in a change in business practice. Our
significant legal proceedings are discussed in Note 18 to the
consolidated financial statements in “Item 8. Financial
Statements and Supplementary Data” in this Annual Report on
Form 10-K.
Income Tax Reserves
We establish reserves when, despite our belief that our tax return
positions are fully supportable, we believe that certain positions
are likely to be challenged and that we may or may not prevail.
Under U.S. GAAP, if we determine that a tax position is more
likely than not of being sustained upon audit, based solely on the
technical merits of the position, we recognize the benefit. We
measure the benefit by determining the amount that is greater
than 50 percent likely of being realized upon settlement. We
presume that all tax positions will be examined by a taxing
authority with full knowledge of all relevant information. The
calculation of our tax liabilities involves dealing with uncertainties
in the application of complex tax regulations in a multitude of
jurisdictions across our global operations. We regularly monitor
our tax positions and tax liabilities. We reevaluate the technical
merits of our tax positions and recognize an uncertain tax
benefit, or derecognize a previously recorded tax benefit, when
there is (i) a completion of a tax audit, (ii) effective settlement of
an issue, (iii) a change in applicable tax law including a tax case or
legislative guidance, or (iv) the expiration of the applicable statute
of limitations. Significant judgment is required in accounting for
tax reserves. Although we believe that we have adequately
provided for liabilities resulting from tax assessments by taxing
authorities, positions taken by these tax authorities could have a
material impact on our effective tax rate, consolidated earnings,
financial position and/or cash flows.
Valuation of Intangible Assets and Goodwill
When we acquire a business, the assets acquired and liabilities
assumed are recorded at their respective fair values at the
acquisition date. Goodwill is the excess of the purchase price
over the estimated fair value of net assets of acquired
businesses. Intangible assets primarily include patents,
trademarks, tradenames, customer relationships, purchased
technology, and IPR&D. Determining the fair value of intangible
assets acquired as part of a business combination requires us to
make significant estimates. These estimates include the amount
and timing of projected future cash flows of each project or
technology, the discount rate used to discount those cash flows
to present value, the assessment of the asset’s life cycle, and the
consideration of legal, technical, regulatory, economic, and
competitive risks.
The test for goodwill impairment requires us to make several
estimates to determine fair value, most of which are based on
projected future cash flows. Our estimates associated with the
goodwill impairment test are considered critical due to the
amount of goodwill recorded on our consolidated balance
sheets and the judgment required in determining fair value. We
assess the impairment of goodwill at the reporting unit level
annually as of the first day of the third quarter and whenever an
event occurs or circumstances change that would indicate that
the carrying amount may be impaired.
We test definite-lived intangible assets for impairment when an
event occurs or circumstances change that would indicate the
carrying amount of the assets or asset group may be impaired.
Our tests are based on future cash flows that require significant
judgment with respect to future revenue and expense growth
rates, appropriate discount rates, asset groupings, and other
assumptions and estimates. We use estimates that are
consistent with the highest and best use of the assets based on
a market participant’s view of the assets being evaluated. Actual
results may differ from our estimates due to a number of factors
including, among others, changes in competitive conditions,
timing of regulatory approval, results of clinical trials, changes in
worldwide economic conditions, and fluctuations in currency
exchange rates.
We assess the impairment of indefinite-lived intangible assets
annually in the third quarter and whenever an event occurs or
circumstances change that would indicate that the carrying
amount may be impaired. Our impairment tests of indefinite-
lived intangible assets require us to make several estimates to
determine fair value, including projected future cash flows and
discount rates.
NEW ACCOUNTING PRONOUNCEMENTS
Information regarding new accounting pronouncements is
included in Note 1 to the consolidated financial statements in
“Item 8. Financial Statements and Supplementary Data” in this
Annual Report on Form 10-K.
SUPPLEMENTAL GUARANTOR FINANCIAL INFORMATION
Medtronic plc and Medtronic Global Holdings S.C.A. (Medtronic
Luxco), a wholly-owned subsidiary guarantor, each have
provided full and unconditional guarantees of the obligations of
Medtronic, Inc., a wholly-owned subsidiary issuer, under the
Senior Notes (Medtronic Senior Notes) and full and unconditional
guarantees of the obligations of Covidien International Finance
S.A. (CIFSA), a wholly-owned subsidiary issuer, under the Senior
Notes (CIFSA Senior Notes). The guarantees of the CIFSA
Senior Notes are in addition to the guarantees of the CIFSA
Senior Notes by Covidien Ltd. and Covidien Group Holdings Ltd.,
both of which are wholly-owned subsidiary guarantors of the
CIFSA Senior Notes. Medtronic plc and Medtronic, Inc. each have
provided a full and unconditional guarantee of the obligations of
Medtronic Luxco under the Senior Notes (Medtronic Luxco
Senior Notes). The following is a summary of these guarantees:
54
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations
Guarantees of Medtronic Senior Notes
Parent Company Guarantor - Medtronic plc
Subsidiary Issuer - Medtronic, Inc.
Subsidiary Guarantor - Medtronic Luxco
Guarantees of Medtronic Luxco Senior Notes
Parent Company Guarantor - Medtronic plc
Subsidiary Issuer - Medtronic Luxco
Subsidiary Guarantor -Medtronic, Inc.
Guarantees of CIFSA Senior Notes
Parent Company Guarantor -Medtronic plc
Subsidiary Issuer - CIFSA
Subsidiary Guarantors - Medtronic Luxco, Covidien Ltd., and
Covidien Group Holdings Ltd. (CIFSA Subsidiary Guarantors)
The following tables present summarized financial information
for the fiscal year ended April 30, 2021 for the obligor groups of
Medtronic and Medtronic Luxco Senior Notes, and CIFSA Senior
Notes. The obligor group consists of the parent company
guarantor, subsidiary issuer, and subsidiary guarantors for the
applicable senior notes. The summarized financial information is
presented after elimination of (i) intercompany transactions and
balances among the guarantors and issuers and (ii) equity in
earnings from and investments in any subsidiary that is a
non-guarantor or issuer.
The summarized results of operations information for the fiscal year ended April 30, 2021 was as follows:
(in millions)
Medtronic & Medtronic
Luxco Senior Notes
(1)
CIFSA Senior Notes
(2)
Net sales $ 1,925 $
Operating profit 11 80
Loss before income taxes (1,201) (741)
Net loss attributable to Medtronic (784) (725)
The summarized balance sheet information for the fiscal year ended April 30, 2021 was as follows:
(in millions)
Medtronic & Medtronic
Luxco Senior Notes
(1)
CIFSA Senior Notes
(2)
Total current assets
(3)
$21,901 $ 9,038
Total noncurrent assets
(4)
11,597 8,041
Total current liabilities
(5)
28,484 17,413
Total noncurrent liabilities
(6)
56,772 63,328
Noncontrolling interests 174 174
(1) The Medtronic Senior Notes and Medtronic Luxco Senior Notes obligor group consists of the following entities: Medtronic plc, Medtronic Luxco, and
Medtronic, Inc. Refer to the guarantee summary above for further details.
(2) The CIFSA Senior Notes obligor group consists of the following entities: Medtronic plc, Medtronic Luxco, CIFSA, and CIFSA Subsidiary Guarantors.
Please refer to the guarantee summary above for further details.
(3) Includes receivables due from non-guarantor subsidiaries of $21.4 billion and $9.0 billion for Medtronic & Medtronic Luxco Senior Notes, and CIFSA
Senior Notes, respectively.
(4) Includes loans receivable due from non-guarantor subsidiaries of $6.5 billion and $8.0 billion for Medtronic & Medtronic Luxco Senior Notes, and
CIFSA Senior Notes, respectively.
(5) Includes payables due to non-guarantor subsidiaries of $26.4 billion and $17.3 billion for Medtronic & Medtronic Luxco Senior Notes, and CIFSA
Senior Notes, respectively.
(6) Includes loans payable due to non-guarantor subsidiaries of $29.0 billion and $43.5 billion for Medtronic & Medtronic Luxco Senior Notes, and CIFSA
Senior Notes, respectively.
MEDTRONIC PLC 2021 Form 10-K 55
PART II
Item 7A Quantitative and Qualitative Disclosures About Market Risk
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
CURRENCY EXCHANGE RATE RISK
Due to the global nature of our operations, we are exposed to
currency exchange rate changes which may cause fluctuations in
earnings and cash flows. We use operational and economic
hedges, as well as currency exchange rate derivative
instruments, to manage the impact of currency exchange rate
fluctuations. In order to minimize earnings and cash flow volatility
resulting from currency exchange rate fluctuations, we enter
into derivative instruments, principally forward currency
exchange rate contracts. These contracts are designed to
hedge anticipated transactions in other currencies and changes
in the value of specific assets and liabilities. At inception of the
contract, the derivative instrument is designated as either a
freestanding derivative or a cash flow hedge. Currencies of our
derivative instruments include the Euro, Japanese Yen, Chinese
Yuan, and others. Fluctuations in the exchange rates of currency
exposures that are unhedged, such as in certain emerging
markets, may result in future earnings and cash flow volatility. We
do not enter into currency exchange rate derivative instruments
for speculative purposes.
The gross notional amount of all currency exchange rate
derivative instruments outstanding at April 30, 2021 and April 24,
2020 was $14.7 billion and $11.9 billion, respectively. At April 30,
2021, these contracts were in a net unrealized loss position of
$211 million. A sensitivity analysis of changes in the fair value of
all currency exchange rate derivative contracts at April 30, 2021
and April 24, 2020 indicates that, if the U.S. dollar uniformly
strengthened/weakened by 10 percent against all currencies, it
would have the following impact on the fair value of these
contracts:
Increase (decrease)
(in millions) 2021 2020
10% appreciation in the U.S. dollar $ 995 $ 750
10% depreciation in the U.S. dollar (995) (750)
Any gains and losses on the fair value of derivative contracts
would generally be offset by gains and losses on the underlying
transactions. These offsetting gains and losses are not reflected
in the above analysis.
In the second quarter of fiscal year 2019, we began accounting
for our operations in Argentina as highly inflationary, as the prior
three-year cumulative inflation rate exceeded 100 percent. The
change did not have a material impact on our results for fiscal
year ended 2021.
INTEREST RATE RISK
We are subject to interest rate risk on our investments and our
borrowings. We manage interest rate risk in the aggregate, while
focusing on our immediate and intermediate liquidity needs. Our
debt portfolio at April 30, 2021 was comprised of debt
predominately denominated in U.S. dollars and the Euro, of which
substantially all is fixed rate debt. We are also exposed to interest
rate changes affecting our investments in interest rate sensitive
instruments, which include our marketable debt securities. We
enter into marketable debt security positions for cash
management purposes.
A sensitivity analysis of the impact on our interest rate-sensitive
financial instruments of a hypothetical 10 basis point change in
interest rates, as compared to interest rates at April 30, 2021
and April 24, 2020, would have the following impact on the fair
value of these instruments:
Increase (decrease)
(in millions) 2021 2020
10 basis point increase in interest rates $21$ 34
10 basis point decrease in interest rates (21) (34)
For a discussion of current market conditions and the impact on
our financial condition and results of operations, please see the
“Liquidity” section of the Management’s Discussion and Analysis
in “Item 7. Management’s Discussion and Analysis of Financial
Condition and Results of Operations” in this Annual Report on
Form 10-K. For additional discussion of market risk, see Notes 5
and 7 to the consolidated financial statements in “Item 8.
Financial Statements and Supplementary Data” in this Annual
Report on Form 10-K.
56
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of Medtronic plc
Opinions on the Financial Statements and
Internal Control over Financial Reporting
We have audited the accompanying consolidated balance sheets
of Medtronic plc and its subsidiaries (the “Company”) as of
April 30, 2021 and April 24, 2020, and the related consolidated
statements of income, of comprehensive income, of equity and
of cash flows for each of the three years in the period ended
April 30, 2021, including the related notes and financial
statement schedule listed in the index appearing under Item
15(a)(1) (collectively referred to as the “consolidated financial
statements”). We also have audited the Company’s internal
control over financial reporting as of April 30, 2021, based on
criteria established in Internal Control—Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations of
the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to
above present fairly, in all material respects, the financial position
of the Company as of April 30, 2021 and April 24, 2020, and the
results of its operations and its cash flows for each of the three
years in the period ended April 30, 2021 in conformity with
accounting principles generally accepted in the United States of
America. Also in our opinion, the Company maintained, in all
material respects, effective internal control over financial
reporting as of April 30, 2021, based on criteria established in
Internal Control—Integrated Framework (2013) issued by the
COSO.
Change in Accounting Principle
As discussed in Note 1 to the consolidated financial statements,
the Company changed the manner in which it accounts for
leases in fiscal year 2020.
Basis for Opinions
The Company’s management is responsible for these
consolidated financial statements, for maintaining effective
internal control over financial reporting, and for its assessment of
the effectiveness of internal control over financial reporting,
included in Management’s Annual Report on Internal Control
Over Financial Reporting appearing under Item 9A. Our
responsibility is to express opinions on the Company’s
consolidated financial statements and on the Company’s
internal control over financial reporting based on our audits. We
are a public accounting firm registered with the Public Company
Accounting Oversight Board (United States) (PCAOB) and are
required to be independent with respect to the Company in
accordance with the U.S. federal securities laws and the
applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.
We conducted our audits in accordance with the standards of
the PCAOB. Those standards require that we plan and perform
the audits to obtain reasonable assurance about whether the
consolidated financial statements are free of material
misstatement, whether due to error or fraud, and whether
effective internal control over financial reporting was maintained
in all material respects.
Our audits of the consolidated financial statements included
performing procedures to assess the risks of material
misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test
basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included
evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the
overall presentation of the consolidated financial statements.
Our audit of internal control over financial reporting 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 audits also
included performing such other procedures as we considered
necessary in the circumstances. We believe that our audits
provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control
over Financial Reporting
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 (i) pertain to the maintenance of records that, in reasonable
detail, accurately and fairly reflect the transactions and
dispositions of the assets of the company; (ii) 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 (iii) 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.
MEDTRONIC PLC 2021 Form 10-K 57
PART II
Item 8 Financial Statements and Supplementary Data
Critical Audit Matters
The critical audit matter communicated below is a matter arising
from the current period audit of the consolidated financial
statements that was communicated or required to be
communicated to the audit committee and that (i) relates to
accounts or disclosures that are material to the consolidated
financial statements and (ii) involved our especially challenging,
subjective, or complex judgments. The communication of critical
audit matters does not alter in any way our opinion on the
consolidated financial statements, taken as a whole, and we are
not, by communicating the critical audit matter below, providing
a separate opinion on the critical audit matter or on the accounts
or disclosures to which it relates.
Income Tax Reserve for the Uncertain Tax Position Related to
Puerto Rico Manufacturing
As described in Notes 13 and 18 to the consolidated financial
statements, management records reserves for uncertain tax
positions related to unresolved matters with the Internal
Revenue Service (IRS) and other taxing authorities. A remaining
unresolved issue with the IRS, relates to the allocation of income
between Medtronic, Inc. and its wholly-owned subsidiary
operating in Puerto Rico, which is one of the Company’s
manufacturing sites. These reserves are subject to a high degree
of estimation and management judgment. Total reserves
relating to uncertain tax positions as of April 30, 2021 were
$1.668 billion, of which the Puerto Rico manufacturing reserve
makes up a significant portion.
The principal considerations for our determination that
performing procedures relating to the income tax reserve for the
uncertain tax position related to Puerto Rico manufacturing is a
critical audit matter are the significant judgment by management
when determining the reserves, including a high degree of
estimation uncertainty relative to the unresolved issue with the
IRS involving one of the Company’s manufacturing sites. This in
turn led to a high degree of auditor judgment, effort and
subjectivity in performing procedures and evaluating audit
evidence to support management’s accurate measurement of
the income tax reserve for the uncertain tax position related to
Puerto Rico manufacturing, as the nature of the evidence is
often highly subjective.
Addressing the matter involved performing procedures and
evaluating audit evidence in connection with forming our overall
opinion on the consolidated financial statements. These
procedures included testing the effectiveness of controls
relating to the recognition of the income tax reserves for
uncertain tax positions, as well as controls over measurement of
the reserves. These procedures also included, among others,
(i) testing management’s process for determining the reserve for
the uncertain tax position, (ii) evaluating the status and results of
the U. S. Tax Court case, and (iii) evaluating the consistency of
the reserve calculation with the relevant documents related to
the tax court case.
/s/ PricewaterhouseCoopers LLP
Minneapolis, Minnesota
June 25, 2021
We have served as the Company’s auditor since 1963.
58
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
Medtronic plc
Consolidated Statements of Income
Fiscal Year
(in millions, except per share data) 2021 2020 2019
Net sales $ 30,117 $ 28,913 $ 30,557
Costs and expenses:
Cost of products sold 10,483 9,424 9,155
Research and development expense 2,493 2,331 2,330
Selling, general, and administrative expense 10,148 10,109 10,418
Amortization of intangible assets 1,783 1,756 1,764
Restructuring charges, net 293 118 198
Certain litigation charges 118 313 166
Other operating expense, net 315 71 258
Operating profit 4,484 4,791 6,268
Other non-operating income, net (336) (356) (373)
Interest expense 925 1,092 1,444
Income before income taxes 3,895 4,055 5,197
Income tax provision (benefit) 265 (751) 547
Net income 3,630 4,806 4,650
Net income attributable to noncontrolling interests (24) (17) (19)
Net income attributable to Medtronic $ 3,606 $ 4,789 $ 4,631
Basic earnings per share $ 2.68 $ 3.57 $ 3.44
Diluted earnings per share $ 2.66 $ 3.54 $ 3.41
Basic weighted average shares outstanding 1,344.9 1,340.7 1,346.4
Diluted weighted average shares outstanding 1,354.0 1,351.1 1,357.5
The accompanying notes are an integral part of these consolidated financial statements.
MEDTRONIC PLC 2021 Form 10-K 59
PART II
Item 8 Financial Statements and Supplementary Data
Medtronic plc
Consolidated Statements of Comprehensive Income
Fiscal Year
(in millions) 2021 2020 2019
Net income $ 3,630 $ 4,806 $ 4,650
Other comprehensive income (loss), net of tax:
Unrealized gain on investment securities 92 45 102
Translation adjustment 1,699 (829) (1,375)
Net investment hedge (1,694) 405 88
Net change in retirement obligations 505 (544) (191)
Unrealized (loss) gain on cash flow hedges (519) 72 401
Other comprehensive income (loss) 83 (851) (975)
Comprehensive income including noncontrolling interests 3,713 3,955 3,675
Comprehensive income attributable to noncontrolling interests (32) (15) (16)
Comprehensive income attributable to Medtronic $ 3,681 $ 3,940 $ 3,659
The accompanying notes are an integral part of these consolidated financial statements.
60 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
Medtronic plc
Consolidated Balance Sheets
(in millions) April 30, 2021 April 24, 2020
ASSETS
Current assets:
Cash and cash equivalents $ 3,593 $ 4,140
Investments 7,224 6,808
Accounts receivable, less allowances and credit losses of $241 and $208, respectively 5,462 4,645
Inventories, net 4,313 4,229
Other current assets 1,955 2,209
Total current assets 22,548 22,031
Property, plant, and equipment, net 5,221 4,828
Goodwill 41,961 39,841
Other intangible assets, net 17,740 19,063
Tax assets 3,169 2,832
Other assets 2,443 2,094
Total assets $ 93,083 $ 90,689
LIABILITIES AND EQUITY
Current liabilities:
Current debt obligations $ 11 $ 2,776
Accounts payable 2,106 1,996
Accrued compensation 2,482 2,099
Accrued income taxes 435 502
Other accrued expenses 3,475 2,993
Total current liabilities 8,509 10,366
Long-term debt 26,378 22,021
Accrued compensation and retirement benefits 1,557 1,910
Accrued income taxes 2,251 2,682
Deferred tax liabilities 1,028 1,174
Other liabilities 1,756 1,664
Total liabilities 41,481 39,817
Commitments and contingencies (Notes 3, 16, and 18)
Shareholders’ equity:
Ordinary shares – par value $0.0001, 2.6 billion shares authorized, 1,345,400,671 and 1,341,074,724 shares issued
and outstanding, respectively ——
Additional paid-in capital 26,319 26,165
Retained earnings 28,594 28,132
Accumulated other comprehensive loss (3,485) (3,560)
Total shareholders’ equity 51,428 50,737
Noncontrolling interests 174 135
Total equity 51,602 50,872
Total liabilities and equity $ 93,083 $ 90,689
The accompanying notes are an integral part of these consolidated financial statements.
MEDTRONIC PLC 2021 Form 10-K 61
PART II
Item 8 Financial Statements and Supplementary Data
Medtronic plc
Consolidated Statements of Equity
Ordinary Shares
Additional
Paid-in Retained
Accumulated
Other
Comprehensive
Total
Shareholders’ Noncontrolling Total
(in millions) Number Par Value Capital Earnings Loss Equity Interests Equity
April 27, 2018 1,354 $ $ 28,127 $ 24,379 $ (1,786) $ 50,720 $ 102 $50,822
Net income 4,631 4,631 19 4,650
Other comprehensive loss (972) (972) (3) (975)
Dividends to shareholders ($2.00
per ordinary share) (2,693) (2,693) (2,693)
Issuance of shares under stock
purchase and award plans 18 923 923 923
Repurchase of ordinary shares (31) (2,808) (2,808) (2,808)
Stock-based compensation 290 290 290
Changes to noncontrolling
ownership interests 3 3
Cumulative effect of change in
accounting principle
(1)
(47) 47
April 26, 2019 1,341 $ $ 26,532 $ 26,270 $ (2,711) $ 50,091 $ 121 $50,212
Net income 4,789 4,789 17 4,806
Other comprehensive loss (849) (849) (2) (851)
Dividends to shareholders ($2.16
per ordinary share) (2,894) (2,894) (2,894)
Issuance of shares under stock
purchase and award plans 12 564 564 564
Repurchase of ordinary shares (12) (1,228) (1,228) (1,228)
Stock-based compensation 297 297 297
Changes to noncontrolling
ownership interests (1) (1)
Cumulative effect of change in
accounting principle
(2)
(33) (33) (33)
April 24, 2020 1,341 $ $ 26,165 $ 28,132 $ (3,560) $ 50,737 $ 135 $50,872
Net income 3,606 3,606 24 3,630
Other comprehensive income 75 75 8 83
Dividends to shareholders ($2.32
per ordinary share) (3,120) (3,120) (3,120)
Issuance of shares under stock
purchase and award plans 8 382 382 382
Repurchase of ordinary shares (4) (559) (559) (559)
Stock-based compensation 344 344 344
Changes to noncontrolling
ownership interests (13) (13) 7 (6)
Cumulative effect of change in
accounting principle
(3)
(24) (24) (24)
April 30, 2021 1,345 $ $ 26,319 $ 28,594 $ (3,485) $ 51,428 $ 174 $51,602
(1) The cumulative effect of change in accounting principle in fiscal year 2019 resulted from the adoption of accounting guidance that requires equity
investments (except those accounted for under the equity method of accounting or those that result in consolidation of the investee) to be
measured at fair value with changes in fair value recognized in net income. As a result of the adoption, the Company reclassified $47 million from
accumulated other comprehensive loss to the opening balance of retained earnings as of April 28, 2018.
(2) The cumulative effect of change in accounting principle in fiscal year 2020 resulted from the adoption of accounting guidance that requires lessees to
recognize right-of-use assets and lease liabilities on the balance sheet. As a result of the adoption, the Company adjusted the opening balance of
retained earnings for $33 million as of April 27, 2019.
(3) See Note 1 to the consolidated financial statements for discussion regarding the adoption of accounting standards during fiscal year 2021.
The accompanying notes are an integral part of these consolidated financial statements.
62 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
Medtronic plc
Consolidated Statements of Cash Flows
Fiscal Year
(in millions) 2021 2020 2019
Operating Activities:
Net income $ 3,630 $ 4,806 $ 4,650
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 2,702 2,663 2,659
Provision for doubtful accounts 128 99 78
Deferred income taxes (422) (1,315) (304)
Stock-based compensation 344 297 290
Loss on debt extinguishment 308 406 457
Other, net 251 217 257
Change in operating assets and liabilities, net of acquisitions and divestitures:
Accounts receivable, net (761) 1,291 (581)
Inventories, net 78 (577) (274)
Accounts payable and accrued liabilities 531 (44) 399
Other operating assets and liabilities (549) (609) (624)
Net cash provided by operating activities 6,240 7,234 7,007
Investing Activities:
Acquisitions, net of cash acquired (994) (488) (1,827)
Additions to property, plant, and equipment (1,355) (1,213) (1,134)
Purchases of investments (11,808) (11,039) (2,532)
Sales and maturities of investments 11,345 9,574 4,683
Other investing activities, net (54) (37) 36
Net cash used in investing activities (2,866) (3,203) (774)
Financing Activities:
Change in current debt obligations, net (311) (17) (713)
Proceeds from short-term borrowings (maturities greater than 90 days) 2,789
Repayments from short-term borrowings (maturities greater than 90 days) (2,853)
Issuance of long-term debt 7,172 5,568 7,794
Payments on long-term debt (7,367) (6,110) (7,948)
Dividends to shareholders (3,120) (2,894) (2,693)
Issuance of ordinary shares 474 662 992
Repurchase of ordinary shares (652) (1,326) (2,877)
Other financing activities (268) (81) 14
Net cash used in financing activities (4,136) (4,198) (5,431)
Effect of exchange rate changes on cash and cash equivalents 215 (86) (78)
Net change in cash and cash equivalents (547) (253) 724
Cash and cash equivalents at beginning of period 4,140 4,393 3,669
Cash and cash equivalents at end of period $ 3,593 $ 4,140 $ 4,393
Supplemental Cash Flow Information
Cash paid for:
Income taxes $ 1,250 $ 878 $ 1,558
Interest 582 643 973
The accompanying notes are an integral part of these consolidated financial statements.
MEDTRONIC PLC 2021 Form 10-K 63
PART II
Item 8 Financial Statements and Supplementary Data
Medtronic plc
Notes to Consolidated Financial Statements
1. Summary of Significant Accounting Policies
Nature of Operations
Medtronic plc (Medtronic or the Company) is among the world’s
largest medical technology, services, and solutions companies
alleviating pain, restoring health, and extending life for millions of
people around the world. The Company provides innovative
products and therapies to serve healthcare systems, physicians,
clinicians, and patients. Medtronic was founded in 1949 and is
headquartered in Dublin, Ireland.
Principles of Consolidation
The consolidated financial statements include the accounts of
Medtronic plc, its wholly-owned subsidiaries, entities for which
the Company has a controlling financial interest, and variable
interest entities for which the Company is the primary
beneficiary. Intercompany transactions and balances have been
fully eliminated in consolidation. Certain reclassifications have
been made to prior year financial statements to conform to
classifications used in the current year. Amounts reported in
millions within this annual report are computed based on the
amounts in thousands, and therefore, the sum of the
components may not equal the total amount reported in millions
due to rounding. Additionally, certain columns and rows within
tables may not sum due to rounding.
Use of Estimates
The preparation of the consolidated financial statements in
conformity with accounting principles generally accepted in the
United States (U.S.) (U.S. GAAP) requires management to make
estimates and assumptions that affect the amounts reported in
the consolidated financial statements and accompanying notes.
Estimates are used when accounting for items such as income
taxes, contingencies, intangible asset, and liability valuations.
Actual results may or may not differ from those estimates.
COVID-19 has had, and may continue to have, an adverse effect
on our business, results of operations, financial condition, and
cash flows, and its future impacts remain highly uncertain and
unpredictable. The Company has considered the disruptions
caused by COVID-19, including lower sales and customer
demand than the prior year in many businesses as well as
macroeconomic factors. As a result, the Company has also
assessed the potential impact on certain accounting estimates
including, but not limited to, the allowance for doubtful accounts,
inventory reserves, return reserves, the valuation of goodwill,
intangible assets, other long-lived assets, investments and
contingent consideration, as of April 30, 2021 and through the
date of this report. There was not a material impact to
accounting estimates associated with the Company’s
consolidated financial statements as of and for the fiscal years
ended April 30, 2021 and April 24, 2020.
Fiscal Year-End
The Company utilizes a 52/53-week fiscal year, ending the last
Friday in April, for the presentation of its consolidated financial
statements and related notes thereto at April 30, 2021 and
April 24, 2020 and for each of the three fiscal years ended
April 30, 2021 (fiscal year 2021), April 24, 2020 (fiscal year 2020),
and April 26, 2019 (fiscal year 2019). Fiscal year 2021 was a
53-week year, with the extra week having occurred in the first
fiscal month of the first quarter. Fiscal years 2020 and 2019 were
52-week years.
Cash Equivalents
The Company considers highly liquid investments with maturities
of three months or less from the date of purchase to be cash
equivalents. These investments are carried at cost, which
approximates fair value.
Investments
The Company invests in marketable debt and equity securities,
investments that do not have readily determinable fair values,
and investments accounted for under the equity method.
Marketable debt securities are classified and accounted for as
available-for-sale. These investments are recorded at fair value
in the consolidated balance sheets. The change in fair value for
available-for-sale securities is recorded, net of taxes, as a
component of accumulated other comprehensive loss on the
consolidated balance sheets. The Company determines the
appropriate classification of its investments in marketable debt
securities at the time of purchase and reevaluates such
determinations at each balance sheet date. The classification of
marketable debt securities as current or long-term is based on
the nature of the securities and the availability for use in current
operations consistent with the Company’s management of its
capital structure and liquidity.
Certain of the Company’s investments in marketable equity
securities and other securities are long-term, strategic
investments in companies that are in various stages of
development and are included in other assets on the
consolidated balance sheets. Marketable equity securities are
recorded at fair value in the consolidated balance sheets. The
change in fair value of marketable equity securities is recognized
within other non-operating income, net in the consolidated
statements of income. At each reporting period, the Company
makes a qualitative assessment considering impairment
indicators to evaluate whether the investment is impaired. Equity
securities accounted for under the equity method are initially
recorded at the amount of the Company’s investment and are
adjusted each period for the Company’s share of the investee’s
64
MEDTRONIC PLC 2021 Form 10-K
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Item 8 Financial Statements and Supplementary Data
income or loss and dividends paid. Securities accounted for
under the equity method are reviewed quarterly for changes in
circumstance or the occurrence of events that suggest other
than temporary impairment has occurred.
Accounts Receivable and Allowance for
Doubtful Accounts and Credit Losses
The Company grants credit to customers in the normal course
of business and maintains an allowance for doubtful accounts for
potential credit losses. When evaluating allowances for doubtful
accounts, the Company considers various factors, including
historical experience and customer-specific information.
Uncollectible accounts are written-off against the allowance
when it is deemed that a customer account is uncollectible.
Inventories
Inventories are stated at the lower of cost or net realizable value,
with cost determined on a first-in, first-out basis. The Company
reduces the carrying value of inventories for items that are
potentially excess, obsolete, or slow-moving based on changes
in customer demand, technology developments, or other
economic factors.
Property, Plant, and Equipment
Property, plant, and equipment is stated at cost and depreciated
over the useful lives of the assets using the straight-line method.
Additions and improvements that extend the lives of the assets
are capitalized, while expenditures for repairs and maintenance
are expensed as incurred. The Company assesses property,
plant, and equipment for impairment whenever events or
changes in circumstances indicate that the carrying amount of
property, plant, and equipment asset groupings may not be
recoverable. The cost of interest that is incurred in connection
with significant ongoing construction projects is capitalized using
a weighted average interest rate. These costs are included in
property, plant, and equipment and amortized over the useful life
of the related asset. Upon retirement or disposal of property,
plant, and equipment, the costs and related amounts of
accumulated depreciation or amortization are eliminated from
the asset and accumulated depreciation accounts. The
difference, if any, between the net asset value and the proceeds,
is recognized in earnings.
Goodwill and Intangible Assets
Goodwill is the excess of the purchase price over the estimated
fair value of net assets of acquired businesses. In accordance
with U.S. GAAP, goodwill is not amortized. The Company
assesses goodwill for impairment annually in the third quarter of
the fiscal year and whenever an event occurs or circumstances
change that would indicate the carrying amount may be
impaired. Impairment testing for goodwill is performed at a
reporting unit level. The test for impairment of goodwill requires
the Company to make several estimates about fair value, most
of which are based on projected future cash flows. The Company
calculates the excess of each reporting unit’s fair value over its
carrying amount, including goodwill, utilizing a discounted cash
flow analysis. Internal operational budgets and long-range
strategic plans are used as a basis for the cash flow analysis. The
Company also utilizes assumptions for working capital, capital
expenditures, and terminal growth rates. The discount rate
applied to the cash flow analysis is based on the weighted
average cost of capital (“WACC”) for each reporting unit. An
impairment loss is recognized when the carrying amount of the
reporting unit’s net assets exceeds the estimated fair value of
the reporting unit.
Intangible assets include patents, trademarks, tradenames,
customer relationships, purchased technology, and in-process
research and development (IPR&D). Intangible assets with a
definite life are amortized on a straight-line basis with estimated
useful lives typically ranging from three to 20 years. Amortization
is recognized within amortization of intangible assets in the
consolidated statements of income. Intangible assets with a
definite life are tested for impairment whenever events or
changes in circumstances indicate that the carrying amount of
an intangible asset (asset group) may not be recoverable. When
events or changes in circumstances indicate that the carrying
amount of an intangible asset may not be recoverable, the
Company calculates the excess of an intangible asset’s carrying
value over its undiscounted future cash flows. If the carrying
value is not recoverable, an impairment loss is recognized based
on the amount by which the carrying value exceeds the fair value.
Acquired IPR&D represents the fair value assigned to those
research and development projects that were acquired in a
business combination for which the related products have not
received regulatory approval and have no alternative future use.
IPR&D is capitalized at its fair value as an indefinite-lived
intangible asset, and any development costs incurred after the
acquisition are expensed as incurred. The fair value of IPR&D is
determined by estimating the future cash flows of each project
and discounting the net cash flows back to their present values.
Upon achieving regulatory approval or commercial viability for
the related product, the indefinite-lived intangible asset is
accounted for as a definite-lived asset and is amortized on a
straight-line basis over the estimated useful life. If the project is
not completed or is terminated or abandoned, the Company
may have an impairment related to the IPR&D, which is charged
to expense. Indefinite-lived intangible assets are tested for
impairment annually in the third quarter of the fiscal year and
whenever events or changes in circumstances indicate that the
carrying amount may be impaired. Impairment is calculated as
the excess of the asset’s carrying value over its fair value. Fair
value is generally determined using a discounted future cash flow
analysis. IPR&D acquired outside of a business combination is
expensed immediately.
Contingent Consideration
Certain of the Company’s business combinations involve
potential payment of future consideration that is contingent
upon the achievement of certain product development
milestones and/or contingent on the acquired business reaching
certain performance milestones. The Company records
contingent consideration at fair value at the date of acquisition
based on the consideration expected to be transferred,
estimated as the probability-weighted future cash flows,
MEDTRONIC PLC 2021 Form 10-K 65
PART II
Item 8 Financial Statements and Supplementary Data
discounted back to present value. The fair value of contingent
consideration is measured using projected payment dates,
discount rates, probabilities of payment, and projected revenues
(for revenue-based considerations). Projected revenues are
based on the Company’s most recent internal operational
budgets and long-range strategic plans. The discount rate used
is determined at the time of measurement in accordance with
accepted valuation methodologies. Changes in projected
revenues, probabilities of payment, discount rates, and projected
payment dates may result in adjustments to the fair value
measurements. Contingent consideration is remeasured each
reporting period using Level 3 inputs, and the change in fair value,
including accretion for the passage of time, is recognized as
income or expense within other operating expense, net in the
consolidated statements of income. Contingent consideration
payments made soon after the acquisition date are classified as
investing activities in the consolidated statements of cash flows.
Contingent consideration payments not made soon after the
acquisition date that are related to the acquisition date fair value
are reported as financing activities in the consolidated
statements of cash flows, and amounts paid in excess of the
original acquisition date fair value are reported as operating
activities in the consolidated statements of cash flows.
Self-Insurance
The Company self-insures the majority of its insurable risks,
including medical and dental costs, disability coverage, physical
loss to property, business interruptions, workers’ compensation,
comprehensive general, and product liability. Insurance coverage
is obtained for risks required to be insured by law or contract.
The Company uses claims data and historical experience, as
applicable, to estimate liabilities associated with the exposures
that the Company has self-insured.
Retirement Benefit Plan Assumptions
The Company sponsors various retirement benefit plans,
including defined benefit pension plans, post-retirement medical
plans, defined contribution savings plans, and termination
indemnity plans, covering substantially all U.S. employees and
many employees outside the U.S. See Note 15 for assumptions
used in determining pension and post-retirement benefit costs
and liabilities.
Derivatives
The Company recognizes all derivative financial instruments in
its consolidated financial statements at fair value in accordance
with authoritative guidance on derivatives and hedging, and
presents assets and liabilities associated with derivative financial
instruments on a gross basis in the consolidated financial
statements. For derivative instruments that are designated and
qualify as hedging instruments, the hedging instrument must be
designated as a fair value hedge or a cash flow hedge, based
upon the exposure being hedged. See Note 7 for more
information on the Company’s derivative instruments and
hedging programs.
Fair Value Measurements
The Company follows the authoritative guidance on fair value
measurements and disclosures with respect to assets and
liabilities that are measured at fair value on both a recurring and
nonrecurring basis. Fair value is defined as the exit price, or the
amount that would be received to sell an asset or paid to transfer
a liability in an orderly transaction between market participants as
of the measurement date. The authoritative guidance also
establishes a hierarchy for inputs used in measuring fair value
that maximizes the use of observable inputs and minimizes the
use of unobservable inputs by requiring that the most observable
inputs be used when available. Observable inputs are inputs
market participants would use in valuing the asset or liability,
based on market data obtained from sources independent of the
Company. Unobservable inputs are inputs that reflect the
Company’s assumptions about the factors market participants
would use in valuing the asset or liability developed based upon
the best information available in the circumstances. The
categorization of financial assets and financial liabilities within the
valuation hierarchy is based upon the lowest level of input that is
significant to the fair value measurement. The hierarchy is
broken down into three levels defined as follows:
Level 1 - Inputs are quoted prices in active markets for
identical assets or liabilities.
Level 2 - Inputs include quoted prices for similar assets or
liabilities in active markets, quoted prices for identical or similar
assets or liabilities in markets that are not active, and inputs
(other than quoted prices) that are observable for the asset or
liability, either directly or indirectly.
Level 3 - Inputs are unobservable for the asset or liability.
Financial assets that are classified as Level 1 securities include
highly liquid government bonds within U.S. government and
agency securities and marketable equity securities for which
quoted market prices are available. In addition, the Company
classifies currency forward contracts as Level 1 since they are
valued using quoted market prices in active markets which have
identical assets or liabilities.
The valuation for most fixed maturity securities are classified as
Level 2. Financial assets that are classified as Level 2 include
corporate debt securities, government and agency securities,
other asset-backed securities, debt funds, and mortgage-
backed securities whose value is determined using inputs that
are observable in the market or may be derived principally from,
or corroborated by, observable market data such as pricing for
similar securities, recently executed transactions, cash flow
models with yield curves, and benchmark securities. In addition,
interest rate swaps and total return swaps are included in Level 2
as the Company uses inputs other than quoted prices that are
observable for the asset. The Level 2 derivative instruments are
primarily valued using standard calculations and models that use
readily observable market data as their basis.
Financial assets are considered Level 3 when their fair values are
determined using pricing models, discounted cash flow
methodologies, or similar techniques, and at least one significant
model assumption or input is unobservable. Financial assets that
are classified as Level 3 include certain investment securities for
which there is limited market activity such that the determination
66
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
of fair value requires significant judgment or estimation, certain
corporate debt securities and auction rate securities. With the
exception of auction rate securities, these securities are valued
using third-party pricing sources that incorporate transaction
details such as contractual terms, maturity, timing, and amount
of expected future cash flows, as well as assumptions about
liquidity and credit valuation adjustments by market participants.
The fair value of auction rate securities is estimated by the
Company using a discounted cash flow model, which
incorporates significant unobservable inputs. The significant
unobservable inputs used in the fair value measurement of the
Company’s auction rate securities are years to principal recovery
and the illiquidity premium that is incorporated into the discount
rate. For goodwill, other intangible assets, and IPR&D, inputs
used in the fair value analysis fall within Level 3 of the fair value
hierarchy due to the use of significant unobservable inputs to
determine fair value.
Certain investments for which the fair value is measured using
the net asset value per share (or its equivalent) practical
expedient are excluded from the fair value hierarchy. Financial
assets for which the fair value is measured using the net asset
value per share practical expedient include certain debt funds,
equity and fixed income commingled trusts, and registered
investment companies.
Revenue Recognition
The Company sells its products through direct sales
representatives and independent distributors. Additionally, a
portion of the Company’s revenue is generated from
consignment inventory maintained at hospitals. The Company
recognizes revenue when control is transferred to the customer.
For products sold through direct sales representatives and
independent distributors, control is transferred upon shipment
or upon delivery, based on the contract terms and legal
requirements. For consignment inventory, control is transferred
when the product is used or implanted. Payment terms vary
depending on the country of sale, type of customer, and type of
product.
If a contract contains more than one performance obligation, the
transaction price is allocated to each performance obligation
based on relative standalone selling price. Shipping and handling
is treated as a fulfillment activity rather than a promised service,
and therefore, is not considered a performance obligation. Taxes
assessed by a governmental authority that are both imposed on,
and concurrent with, a specific revenue producing transaction
and collected by the Company from customers (for example,
sales, use, value added, and some excise taxes) are not included
in revenue. For contracts that have an original duration of one
year or less, the Company uses the practical expedient
applicable to such contracts and does not adjust the transaction
price for the time value of money.
The amount of revenue recognized reflects sales rebates and
returns, which are estimated based on sales terms, historical
experience, and trend analysis. In estimating rebates, the Company
considers the lag time between the point of sale and the payment
of the rebate claim, the stated rebate rates, and other relevant
information. The Company records adjustments to rebates and
returns reserves as increases or decreases of revenue.
The Company records a deferred revenue liability if a customer
pays consideration before the Company transfers a good or
service to the customer. Deferred revenue primarily represents
remote monitoring services and equipment maintenance, for
which consideration is received at the same time as
consideration for the device or equipment. Revenue related to
remote monitoring services and equipment maintenance is
recognized over the service period as time elapses.
Remaining performance obligations include deferred revenue
and amounts the Company expects to receive for goods and
services that have not yet been delivered or provided under
existing, noncancellable contracts with minimum purchase
commitments, primarily related to consumables for previously
sold equipment as well as remote monitoring services and
equipment maintenance. For contracts that have an original
duration of one year or less, the Company has elected the
practical expedient applicable to such contracts and does not
disclose the transaction price for remaining performance
obligations at the end of each reporting period and when the
Company expects to recognize this revenue.
Shipping and Handling
Shipping and handling costs incurred to physically move product
from the Company’s premises to the customer’s premises are
recognized in selling, general, and administrative expense in the
consolidated statements of income and were $308 million,
$347 million, and $350 million in fiscal years 2021, 2020, and
2019, respectively. Other shipping and handling costs incurred to
store, move, and prepare products for shipment are recognized
in cost of products sold in the consolidated statements of
income.
Research and Development
Research and development costs are expensed when incurred.
Research and development costs include costs of research,
engineering, and technical activities to develop a new product or
service or make significant improvement to an existing product
or manufacturing process. Research and development costs
also include pre-approval regulatory and clinical trial expenses.
Contingencies
The Company records a liability in the consolidated financial
statements for loss contingencies when a loss is known or
considered probable, and the amount may 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 other, the minimum amount of the range is
accrued. If a loss is reasonably possible but not known or
probable, and may be reasonably estimated, the estimated loss
or range of loss is disclosed.
Income Taxes
The Company has deferred taxes that arise as a result of the
different treatment of transactions for U.S. GAAP and income
tax accounting, known as temporary differences. The Company
records the tax effect of these temporary differences as
MEDTRONIC PLC 2021 Form 10-K 67
PART II
Item 8 Financial Statements and Supplementary Data
deferred tax assets and deferred tax liabilities. Deferred tax
assets generally represent items that may be used as a tax
deduction or credit in a tax return in future years for which the
Company has already recognized the tax benefit in the
consolidated statements of income. The Company establishes
valuation allowances for deferred tax assets when the amount of
expected future taxable income is not likely to support the use of
the deduction or credit. Deferred tax liabilities generally
represent tax expense for which payment has been deferred or
expense has already been taken as a deduction on the
Company’s tax return but has not yet been recognized as an
expense in the consolidated statements of income.
Other Operating Expense, Net
Other operating expense, net primarily includes royalty income
and expense, currency remeasurement and derivative gains and
losses, Puerto Rico excise taxes, changes in fair value of
contingent consideration, changes in amounts accrued for
certain contingent liabilities for a recent acquisition, a
commitment to the Medtronic Foundation, charges associated
with business exits, impairment charges, IPR&D charges, and
income from funded research and development arrangements.
Other Non-Operating Income, Net
Other non-operating income, net includes the non-service
component of net periodic pension and post-retirement benefit
cost, investment gains and losses, and interest income.
Currency Translation
Assets and liabilities of non-U.S. dollar functional currency
entities are translated to U.S. dollars at period-end exchange
rates, and the currency impacts arising from the translation of
the assets and liabilities are recorded as a cumulative translation
adjustment, a component of accumulated other comprehensive
loss, on the consolidated balance sheets. Elements of the
consolidated statements of income are translated at the
average monthly currency exchange rates in effect during the
period. Currency transaction gains and losses are included in
other operating expense, net in the consolidated statements of
income.
Stock-Based Compensation
The Company measures stock-based compensation expense at
the grant date based on the fair value of the award and
recognizes the compensation expense over the requisite service
period, which is generally the vesting period. The amount of
stock-based compensation expense recognized during a period
is based on the portion of the awards that are expected to vest.
The Company estimates pre-vesting forfeitures at the time of
grant and revises the estimates in subsequent periods.
Recently Adopted Accounting Standards
Current Expected Credit Losses
In June 2016, the Financial Accounting Standards Board (FASB)
issued guidance changing the methodology to be used to
measure credit losses for certain financial instruments and
financial assets, including trade receivables. The new
methodology requires the recognition of an allowance that
reflects the current estimate of credit losses expected to be
incurred over the life of the financial asset. The Company
adopted this guidance using the modified retrospective method
in the first quarter of fiscal year 2021. The adoption of this
guidance did not have a material impact to the Company’s
consolidated financial statements.
Leases
In February 2016, the FASB issued guidance which requires
lessees to recognize right-of-use assets and lease liabilities on
the balance sheet. This guidance also requires additional
qualitative and quantitative lease related disclosures in the notes
to the consolidated financial statements. The Company adopted
this guidance using the modified retrospective method in the
first quarter of fiscal year 2020.
During the implementation, the Company elected the package
of practical expedients available under the transition guidance
that allowed an entity not to reassess whether any expired or
existing contracts are or contain leases, the classification for any
expired or existing leases or any initial direct costs for existing
leases. Further, the Company made accounting policy elections
to not apply the recognition requirements to short-term leases
and to account for lease and nonlease components as a single
lease component.
The adoption of this guidance resulted in the recognition of
right-of-use assets and lease liabilities in an amount of
approximately $1.0 billion, an immaterial cumulative-effect
adjustment to retained earnings as of April 27, 2019, and
expansion of lease related disclosures. The adoption of this
guidance did not have a material impact on the Company’s
consolidated statements of income or consolidated statements
of cash flows.
2. Revenue
The Company’s revenues are principally derived from device-
based medical therapies and services related to cardiac rhythm
disorders, cardiovascular disease, renal disease, neurological
disorders and diseases, spinal conditions and musculoskeletal
trauma, chronic pain, urological and digestive disorders, ear,
nose, and throat conditions, and diabetes conditions as well as
advanced and general surgical care products, respiratory and
monitoring solutions, and neurological surgery technologies.
The Company’s primary customers include healthcare systems,
clinics, third-party healthcare providers, distributors, and other
institutions, including governmental healthcare programs and
group purchasing organizations.
68
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
During the first and fourth quarters of fiscal year 2021, the
Company realigned its divisions within Neuroscience and
Cardiovascular, respectively. As a result, fiscal year 2020 and
2019 revenue has been recast to adjust for these realignments
Additionally, the Company implemented a new operating model
in fiscal year 2021, which was fully operational beginning in the
fourth quarter.
The table below illustrates net sales by segment and division for fiscal years 2021, 2020, and 2019:
Net Sales by Fiscal Year
(in millions) 2021 2020 2019
Cardiac Rhythm & Heart Failure $ 5,584 $ 5,141 $ 5,849
Structural Heart & Aortic 2,834 2,842 2,882
Coronary & Peripheral Vascular 2,354 2,486 2,774
Cardiovascular 10,772 10,468 11,505
Surgical Innovations 5,438 5,513 5,753
Respiratory, Gastrointestinal, & Renal 3,298 2,839 2,725
Medical Surgical 8,737 8,352 8,478
Cranial & Spinal Technologies 4,288 4,082 4,252
Specialty Therapies 2,307 2,147 2,195
Neuromodulation 1,601 1,497 1,736
Neuroscience 8,195 7,725 8,183
Diabetes 2,413 2,368 2,391
Total $ 30,117 $ 28,913 $ 30,557
The table below includes net sales by market geography and segment for fiscal years 2021, 2020, and 2019:
U.S.
(1)
Non-U.S. Developed Markets
(2)
Emerging Markets
(3)
(in millions)
Fiscal Year
2021
Fiscal Year
2020
Fiscal Year
2019
Fiscal Year
2021
Fiscal Year
2020
Fiscal Year
2019
Fiscal Year
2021
Fiscal Year
2020
Fiscal Year
2019
Cardiovascular $ 5,248 $ 5,062 $ 5,750 $ 3,752 $ 3,519 $ 3,767 $ 1,773 $ 1,887 $ 1,988
Medical
Surgical 3,650 3,532 3,630 3,320 3,169 3,250 1,766 1,651 1,598
Neuroscience 5,456 5,122 5,478 1,724 1,659 1,759 1,015 945 946
Diabetes 1,171 1,204 1,336 1,019 940 855 222 224 200
Total $ 15,526 $ 14,919 $ 16,194 $ 9,815 $ 9,287 $ 9,631 $ 4,777 $ 4,707 $ 4,732
(1) U.S. includes the United States and U.S. territories.
(2) Non-U.S. developed markets include Japan, Australia, New Zealand, Korea, Canada, and the countries within Western Europe.
(3) Emerging markets include the countries of the Middle East, Africa, Latin America, Eastern Europe, and the countries of Asia that are not included in
the non-U.S. developed markets, as defined above.
At April 30, 2021, $906 million of rebates were classified as other
accrued expenses, and $485 million of rebates were classified as
a reduction of accounts receivable in the consolidated balance
sheet. At April 24, 2020, $706 million of rebates were classified as
other accrued expenses, and $321 million of rebates were
classified as a reduction of accounts receivable in the
consolidated balance sheet. During fiscal year 2021,
adjustments to rebate and return reserves recognized in
revenue that were included in the rebate and return reserves at
the beginning of the period were not material.
Deferred Revenue and Remaining Performance
Obligations
Deferred revenue at April 30, 2021 and April 24, 2020 was
$368 million and $303 million, respectively. At April 30, 2021 and
April 24, 2020, $276 million and $213 million was included in other
accrued expenses, respectively, and $93 million and $90 million
was included in other liabilities, respectively. During the fiscal
year ended April 30, 2021, the Company recognized $236
million of revenue that was included in deferred revenue as
of April 24, 2020.
At April 30, 2021, the estimated revenue expected to be
recognized in future periods related to performance obligations
that are unsatisfied for executed contracts with an original
duration of one year or more was approximately $1.3 billion. The
Company expects to recognize revenue on the majority of these
remaining performance obligations over the next four years.
MEDTRONIC PLC 2021 Form 10-K 69
PART II
Item 8 Financial Statements and Supplementary Data
3. Acquisitions
The Company had acquisitions during fiscal years 2021 and 2020
that were accounted for as business combinations. The assets
and liabilities of businesses acquired were recorded and
consolidated on the acquisition date at their respective fair
values. Goodwill resulting from business combinations is largely
attributable to future yet to be defined technologies, new
customer relationships, existing workforce of the acquired
businesses, and synergies expected to arise after the
Company’s acquisition of these businesses. The pro forma
impact of acquisitions during fiscal years 2021 and 2020 was not
significant, either individually or in the aggregate, to the
consolidated results of the Company. The results of operations
of acquired businesses have been included in the Company’s
consolidated statements of income since the date each
business was acquired.
Fiscal Year 2021
The acquisition date fair value of net assets acquired during fiscal
year 2021 was $1.2 billion, consisting of $1.4 billion of assets
acquired and $161 million of liabilities assumed. Based upon
preliminary valuations, assets acquired were primarily comprised
of $417 million of technology-based intangible assets and
$13 million of customer-related intangible assets with estimated
useful lives ranging from 8 to 15 years, and $816 million of
goodwill. The goodwill is not deductible for tax purposes. The
Company recognized $253 million of contingent consideration
liabilities in connection with business combinations during fiscal
year 2021, which are comprised of revenue and regulatory
milestone-based payments. Additionally, the Company
recognized a gain of $132 million related to a change in amounts
accrued for certain contingent liabilities from a recent
acquisition. The benefit was recognized in other operating
expense, net in the consolidated statements of income as the
purchase accounting was finalized in fiscal year 2020. Purchase
price allocation adjustments for fiscal year 2021 business
combinations were not significant.
Fiscal Year 2020
The acquisition date fair value of net assets acquired during fiscal
year 2020 was $612 million, consisting of $679 million of assets
acquired and $67 million of liabilities assumed. Assets acquired
were primarily comprised of $236 million of technology-based
intangible assets and $26 million of customer-related intangible
assets with estimated useful lives ranging from 8 to 16 years,
$333 million of goodwill, and $40 million of inventory. The
goodwill is not deductible for tax purposes. The Company
recognized $80 million of contingent consideration liabilities in
connection with business combinations during fiscal year 2020,
which are comprised of revenue and regulatory milestone-based
payments. Purchase price allocation adjustments for fiscal year
2020 business combinations were not significant.
Contingent Consideration
The fair value of contingent consideration at April 30, 2021 and
April 24, 2020 was $270 million and $280 million, respectively. At
April 30, 2021, $78 million was recorded in other accrued
expenses, and $192 million was recorded in other liabilities on the
consolidated balance sheets. At April 24, 2020, $112 million was
reflected in other accrued expenses, and $168 million was
reflected in other liabilities on the consolidated balance sheets.
The following table provides a reconciliation of the beginning and ending balances of contingent consideration:
Fiscal Year
(in millions) 2021 2020
Beginning Balance $ 280 $ 222
Purchase price contingent consideration 253 125
Payments (299) (34)
Change in fair value 36 (33)
Ending Balance $ 270 $ 280
The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following
significant unobservable inputs:
(in millions)
Fair Value at
April 30, 2021 Unobservable Input Range
Weighted
Average
(1)
Discount rate 11.2%-31.6% 17.0%
Revenue and other performance-based payments $ 250 Probability of payment 30%-100% 99.1%
Projected fiscal year of payment 2022-2027 2025
Discount rate 5.5% 5.5%
Product development and other milestone-based payments $ 20 Probability of payment 100% 100%
Projected fiscal year of payment 2022-2027 2025
(1) Unobservable inputs were weighted by the relative fair value of the contingent consideration liability. For projected fiscal year of payment, the
amount represents the median of the inputs and is not a weighted average.
70 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
4. Restructuring Charges
Enterprise Excellence
In the third quarter of fiscal year 2018, the Company announced
its Enterprise Excellence restructuring program, which is
expected to leverage the Company’s global size and scale, as
well as enhance the customer and employee experience, with a
focus on three objectives: global operations, functional
optimization, and commercial optimization. Primary activities of
the restructuring program include integrating and enhancing
global manufacturing and supply processes, systems and site
presence, enhancing and leveraging global operating models
across several enabling functions, and optimizing certain
commercial processes, systems, and models.
The Company estimates that, in connection with its Enterprise
Excellence restructuring program, it will recognize pre-tax exit
and disposal costs and other costs across all segments of
approximately $1.6 billion to $1.8 billion, the majority of which are
expected to be incurred by the end of fiscal year 2022.
Approximately 40 percent of the estimated charges are related
to employee termination benefits. The remaining charges are
costs associated with the restructuring program, such as salaries
and benefits for employees supporting the program, including
program management and transition teams, and strategic and
operational consulting services related to the three objectives of
the program discussed above. These charges are recognized
within restructuring charges, net, cost of products sold, and
selling, general, and administrative expense in the consolidated
statements of income.
For fiscal years 2021, 2020 and 2019, the Company recognized
net charges of $349 million, $441 million, and $424 million,
respectively. For fiscal years 2021, 2020 and 2019, charges
included $128 million, $155 million, and $91 million, respectively,
recognized within cost of products sold, and $169 million,
$168 million, and $118 million, respectively, recognized within
selling, general, and administrative expense in the consolidated
statements of income.
The following table summarizes the activity related to the Enterprise Excellence restructuring program for fiscal years 2021, 2020, and
2019:
(in millions)
Employee
Termination Benefits
Associated
Costs
(1)
Asset
Write-downs
Other
Costs Total
April 27, 2018 $ 27 $ 2 $ $ $ 29
Charges 192 193 17 22 424
Cash payments (118) (186) (10) (314)
Settled non-cash (17) (17)
April 26, 2019 101 9 12 122
Charges 129 300 24 9 462
Cash payments (128) (290) (9) (427)
Settled non-cash (24) (24)
Accrual adjustments
(2)
(13) (8) (21)
April 24, 2020 89 19 4 112
Charges 66 295 4 365
Cash payments (77) (296) (5) (378)
Accrual adjustments
(2)
(14) (2) (16)
April 30, 2021 $ 64 $ 18 $ $ 1 $ 83
(1) Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program and
consulting expenses.
(2) Accrual adjustments relate to certain employees identified for termination finding other positions within Medtronic and contract terminations being
settled for less than originally estimated.
Simplification
In the first quarter of fiscal year 2021, the Company initiated the Simplification restructuring program, designed to make the Company a
more nimble and competitive organization focused on accelerating innovation, enhancing the customer experience, driving revenue
growth, and winning market share, while also more efficiently and effectively leveraging the enterprise scale. Under the oversight of the
portfolio leaders, this new operating model, which became fully operational the beginning of the fourth quarter of fiscal year 2021, will
simplify the Company’s organizational structure and accelerate decision-making and execution. Primary activities of the restructuring
program will include reorganizing the Company into a portfolio-level structure, including the creation of highly focused, accountable, and
empowered Operating Units (OUs), consolidating Operations at the enterprise level, establishing Technology Development Centers in
areas where the Company has deep core technology competencies to be leveraged by multiple OUs, and forming dedicated sales
organizations that leverage the Company’s scale but move with the same agility as smaller, local competitors.
MEDTRONIC PLC 2021 Form 10-K 71
PART II
Item 8 Financial Statements and Supplementary Data
The Company estimates that, in connection with its
Simplification restructuring program, it will recognize pre-tax exit
and disposal costs and other costs across all segments of
approximately $400 million to $450 million, the majority of which
are expected to be incurred by the end of fiscal year 2022.
Approximately three quarters of the estimated charges are
related to employee termination benefits. The remaining
charges are costs associated with the restructuring program,
such as salaries for employees supporting the program and
consulting expenses to execute the reorganization of our
business into a portfolio-like structure as discussed above.
These charges are recognized within restructuring charges, net
and selling, general, and administrative expense in the
consolidated statements of income.
For fiscal year 2021, the Company recognized net charges of
$268 million, which included $97 million of incremental defined
benefit pension and post-retirement related expenses for
employees that accepted voluntary early retirement packages.
These costs are not included in the table summarizing
restructuring charges below, as they are associated with costs
that are accounted for under the pension and post-retirement
rules. See Note 15 for further discussion on the incremental
defined benefit pension and post-retirement expenses. The
charges recognized for fiscal year 2021 included $27 million
recognized within selling, general, and administrative expense in
the consolidated statements of income.
The following table summarizes the activity related to the Simplification restructuring program for fiscal year 2021:
(in millions)
Employee
Termination Benefits
Associated
Costs
(1)
Total
April 24, 2020 $— $$—
Charges 147 27 174
Cash payments (85) (23) (108)
Accrual adjustments
(2)
(3) (3)
April 30, 2021 $59 $4$63
(1) Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program and
consulting expenses.
(2) Accrual adjustments relate to certain employees identified for termination finding other positions within the Company.
72 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
5. Financial Instruments
Debt Securities
The Company holds investments in marketable debt securities that are classified and accounted for as available-for-sale and are
remeasured on a recurring basis. The following tables summarize the Company’s investments in available-for-sale debt securities by
significant investment category and the related consolidated balance sheet classification at April 30, 2021 and April 24, 2020:
April 30, 2021
Valuation Balance Sheet Classification
(in millions) Cost
Unrealized
Gains
Unrealized
Losses Fair Value Investments Other Assets
Level 1:
U.S. government and agency securities $ 505 $ 26 $ (3) $ 528 $ 528 $
Level 2:
Corporate debt securities 4,557 103 (13) 4,647 4,647
U.S. government and agency securities 810 (7) 804 804
Mortgage-backed securities 645 21 (16) 650 650
Non-U.S. government and agency securities 31 1 33 33
Certificates of deposit 19 19 19
Other asset-backed securities 534 4 (1) 537 537
Debt funds 7 7 7
Total Level 2 6,603 129 (36) 6,696 6,696
Level 3:
Auction rate securities 36 (3) 33 33
Total available-for-sale debt securities $ 7,144 $ 155 $ (42) $ 7,257 $ 7,224 $ 33
April 24, 2020
Valuation Balance Sheet Classification
(in millions) Cost
Unrealized
Gains
Unrealized
Losses Fair Value Investments Other Assets
Level 1:
U.S. government and agency securities $ 542 $ 47 $ $ 589 $ 589 $
Level 2:
Corporate debt securities 4,285 66 (90) 4,261 4,261
U.S. government and agency securities 746 1 747 747
Mortgage-backed securities 705 20 (28) 697 697
Non-U.S. government and agency securities 34 34 34
Other asset-backed securities 499 1 (20) 480 480
Total Level 2 6,269 88 (138) 6,219 6,219
Level 3:
Auction rate securities 36 (3) 33 33
Total available-for-sale debt securities $ 6,847 $ 135 $ (141) $ 6,841 $ 6,808 $ 33
The amortized cost of debt securities excludes accrued interest, which is reported in other current assets in the consolidated balance
sheets.
MEDTRONIC PLC 2021 Form 10-K 73
PART II
Item 8 Financial Statements and Supplementary Data
The following tables present the gross unrealized losses and fair values of the Company’s available-for-sale debt securities that have
been in a continuous unrealized loss position deemed to be temporary, aggregated by investment category at April 30, 2021 and
April 24, 2020:
April 30, 2021
Less than 12 months More than 12 months
(in millions) Fair Value
Unrealized
Losses Fair Value
Unrealized
Losses
U.S. government and agency securities $ 946 $ (10) $ $
Corporate debt securities 1,437 3,209 (13)
Mortgage-backed securities 1 650 (16)
Other asset-backed securities 6 531 (1)
Auction rate securities 33 (3)
Total $ 2,389 $ (10) $ 4,423 $ (32)
April 24, 2020
Less than 12 months More than 12 months
(in millions) Fair Value
Unrealized
Losses Fair Value
Unrealized
Losses
Corporate debt securities $ 1,368 $ (2) $ 2,893 $ (88)
Mortgage-backed securities 35 (1) 663 (27)
Other asset-backed securities 17 463 (20)
Auction rate securities 33 (3)
Total $ 1,453 $ (6) $ 4,019 $ (135)
The Company reviews the fair value hierarchy classification on a
quarterly basis. Changes in the ability to observe valuation inputs
may result in a reclassification of levels for certain securities
within the fair value hierarchy. There were no transfers into or
out of Level 3 during the fiscal years ended April 30, 2021 and
April 24, 2020. When a determination is made to classify an asset
or liability within Level 3, the determination is based upon the
significance of the unobservable inputs to the overall fair value
measurement.
Activity related to the Company’s available for sale securities portfolio is as follows:
(in millions) April 30, 2021 April 24, 2020 April 26, 2019
Proceeds from sales and maturities $ 10,420 $ 9,559 $ 3,718
Gross realized gains 15 25 18
Gross realized losses (14) (22) (62)
During the fiscal year ended April 30, 2021, the Company had
proceeds from maturities of investments classified as held to
maturity of $911 million.
The April 30, 2021 balance of available-for-sale debt securities
by contractual maturity is shown in the following table. Within the
table, maturities of mortgage-backed securities have been
allocated based upon timing of estimated cash flows assuming
no change in the current interest rate environment. Actual
maturities may differ from contractual maturities because the
issuers of the securities may have the right to prepay obligations
without prepayment penalties.
(in millions) April 30, 2021
Due in one year or less $ 1,891
Due after one year through five years 2,862
Due after five years through ten years 1,838
Due after ten years 666
Total debt securities $ 7,257
74 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
Equity Securities, Equity Method
Investments, and Other Investments
The Company commonly holds investments in equity securities
with readily determinable fair values, equity investments without
readily determinable fair values, investments accounted for
under the equity method, and other investments. Equity
securities with readily determinable fair values are included within
Level 1 of the fair value hierarchy, as they are measured using
quoted market prices. Equity method investments and
investments without readily determinable fair values are included
within Level 3 of the fair value hierarchy due to the use of
significant unobservable inputs to determine fair value. To
determine the fair value of these investments, the Company
uses all pertinent financial information available related to the
investees, including financial statements, market participant
valuations from recent and proposed equity offerings, and other
third-party data.
The following table summarizes the Company’s equity and other investments at April 30, 2021 and April 24, 2020, which are classified as
other assets in the consolidated balance sheets:
(in millions) April 30, 2021 April 24, 2020
Investments with readily determinable fair values (marketable equity securities) $ 74 $ 18
Investments without readily determinable fair values 537 391
Equity method and other investments 76 71
Total equity and other investments $ 687 $ 480
The table below includes activity related to the Company’s portfolio of equity and other investments. Gains and losses on equity and
other investments are recognized in other non-operating income, net in the consolidated statements of income.
(in millions) April 30, 2021 April 24, 2020 April 26, 2019
Proceeds from sales $ 13 $ 15 $ 964
Gross gains 68 17 134
Gross losses (3) (30) (30)
Recognized impairment losses (4) (4) (45)
During the fiscal year ended April 30, 2021, there were
$63 million of net unrealized gains on equity securities and other
investments still held at April 30, 2021. During the fiscal year
ended April 24, 2020, there were $15 million of net unrealized
losses on equity securities and other investments still held at
April 24, 2020.
6. Financing Arrangements
Current debt obligations consisted of the following:
(in millions) April 30, 2021 April 24, 2020
Bank borrowings $ 2 $ 325
0.000 percent two-year 2019 senior notes 1,631
Floating rate two-year 2019 senior notes 815
Finance lease obligations 95
Current debt obligations $ 11 $ 2,776
MEDTRONIC PLC 2021 Form 10-K 75
PART II
Item 8 Financial Statements and Supplementary Data
Bank Borrowings
Outstanding bank borrowings at April 30, 2021 were not
significant. Outstanding bank borrowings at April 24, 2020 were
short-term advances primarily to non-U.S. subsidiaries under
credit agreements with various banks. These bank borrowings
consisted primarily of borrowings in Japanese Yen at an interest
rate of 0.21%, and were a natural hedge of currency and
exchange rate risk.
Commercial Paper
On January 26, 2015, Medtronic Global Holdings S.C.A.
(Medtronic Luxco), an entity organized under the laws of
Luxembourg, entered into various agreements pursuant to
which Medtronic Luxco may issue United States Dollar-
denominated unsecured commercial paper notes (the 2015 CP
Program) on a private placement basis, and on January 31, 2020
Medtronic Luxco entered into various agreements pursuant to
which Medtronic Luxco may issue Euro-denominated unsecured
commercial paper notes (the 2020 CP Program) on a private
placement basis. The Maximum aggregate amount outstanding
at any time under the 2015 CP Program and the 2020 CP
Program together may not exceed the equivalent of $3.5 billion.
The Company and Medtronic, Inc. have guaranteed the
obligations of Medtronic Luxco under the 2015 CP Program and
the 2020 CP Program.
There was no commercial paper outstanding at April 30, 2021
and April 24, 2020 or during fiscal year 2021. During fiscal year
2020, the weighted average original maturity of the commercial
paper outstanding was approximately 7 days and the weighted
average interest rate was 2.31 percent. The issuance of
commercial paper reduces the amount of credit available under
the Company’s existing credit facility, defined below.
Line of Credit
On December 12, 2020, Medtronic Luxco, as borrower, entered
into an amendment to its amended and restated credit
agreement (Credit Facility), by and among Medtronic, Medtronic,
Inc., Medtronic Luxco, the lenders from time to time party
thereto, and Bank of America, N.A., as administrative agent and
issuing bank, extending the maturity date of the Credit Facility to
December 2025.
The Credit Facility provides for a $3.5 billion five-year unsecured
revolving credit facility (Credit Facility). At each anniversary date
of the Credit Facility, but not more than twice prior to the
maturity date, the Company could also request a one-year
extension of the maturity date. The Credit Facility provides the
Company with the ability to increase its borrowing capacity by an
additional $1.0 billion at any time during the term of the
agreement. The Company and Medtronic, Inc. have guaranteed
the obligations of the borrowers under the Credit Facility, and
Medtronic Luxco will also guarantee the obligations of any
designated borrower. The Credit Facility includes a multi-
currency borrowing feature for certain specified foreign
currencies. At April 30, 2021 and April 24, 2020, no amounts
were outstanding under the Credit Facility.
Interest rates on advances on the Credit Facility are determined
by a pricing matrix based on the Company’s long-term debt
ratings, assigned by Standard & Poor’s Ratings Services and
Moody’s Investors Service. Facility fees are payable on the Credit
Facility and are determined in the same manner as the interest
rates. The Company is in compliance with all covenants related
to the Credit Facility.
76
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
Long-term debt consisted of the following:
April 30, 2021 April 24, 2020
(in millions, except interest rates)
Maturity by
Fiscal Year Amount
Effective
Interest Rate Amount
Effective
Interest Rate
3.150 percent seven-year 2015 senior notes 2022 $ —% $ 1,534 3.29%
3.200 percent ten-year 2012 CIFSA senior notes 2023 650 2.72
2.750 percent ten-year 2013 senior notes 2023 530 3.25
0.000 percent three-year 2019 senior notes 2023 907 0.08 815 0.09
0.375 percent four-year 2019 senior notes 2023 1,813 0.55 1,631 0.56
0.000 percent two-year 2020 senior notes 2023 1,511 0.12
2.950 percent ten-year 2013 CIFSA senior notes 2024 310 2.71
3.625 percent ten-year 2014 senior notes 2024 432 3.61
3.500 percent ten-year 2015 senior notes 2025 1,890 3.74 2,700 3.74
0.250 percent six-year 2019 senior notes 2026 1,209 0.43 1,087 0.44
0.000 percent five-year 2020 senior notes 2026 1,209 0.22
1.125 percent eight-year 2019 senior notes 2027 1,813 1.24 1,631 1.25
3.350 percent ten-year 2017 senior notes 2027 368 3.53 368 3.53
0.375 percent eight-year 2020 senior notes 2029 1,209 0.51
1.625 percent twelve-year 2019 senior notes 2031 1,209 1.74 1,087 1.75
1.000 percent twelve-year 2019 senior notes 2032 1,209 1.05 1,087 1.06
0.750 percent twelve-year 2020 senior notes 2033 1,209 0.81
4.375 percent twenty-year 2015 senior notes 2035 1,932 4.47 1,932 4.47
6.550 percent thirty-year 2007 CIFSA senior notes 2038 253 4.67 253 4.68
2.250 percent twenty-year 2019 senior notes 2039 1,209 2.34 1,087 2.34
6.500 percent thirty-year 2009 senior notes 2039 158 6.56 158 6.56
1.500 percent twenty-year 2019 senior notes 2040 1,209 1.58 1,087 1.58
5.550 percent thirty-year 2010 senior notes 2040 224 5.58 224 5.58
1.375 percent twenty-year 2020 senior notes 2041 1,209 1.46
4.500 percent thirty-year 2012 senior notes 2042 105 4.54 105 4.54
4.000 percent thirty-year 2013 senior notes 2043 305 4.09 305 4.10
4.625 percent thirty-year 2014 senior notes 2044 127 4.67 127 4.67
4.625 percent thirty-year 2015 senior notes 2045 1,813 4.69 1,813 4.67
1.750 percent thirty-year 2019 senior notes 2050 1,209 1.87 1,087 1.87
1.625 percent thirty-year 2020 senior notes 2051 1,209 1.75
Bank borrowings N/A 55 2.11
Finance lease obligations 2022-2059 62 9.29 45 8.93
Debt discount, net 2022-2051 (75) (15)
Deferred financing costs 2022-2051 (125) (104)
Long-term debt $ 26,378 $ 22,021
Senior Notes
The Company has outstanding unsecured senior obligations,
described as senior notes in the tables above (collectively, the
Senior Notes). The Senior Notes rank equally with all other
unsecured and unsubordinated indebtedness of the Company.
The Company is in compliance with all covenants related to the
Seniors notes.
In June 2019, Medtronic Luxco issued six tranches of Euro-
denominated Senior Notes with an aggregate principal of
5.0 billion, with maturities ranging from fiscal year 2021 to fiscal
year 2050, resulting in cash proceeds of approximately
$5.6 billion, net of discounts and issuance costs. The Company
used the net proceeds of the offering to fund the cash tender
offer and early redemption of $5.2 billion of Medtronic Inc.,
CIFSA, and Medtronic Luxco Senior Notes for $5.6 billion of total
consideration. The Company recognized a loss on debt
extinguishment of $413 million in fiscal year 2020, which primarily
included cash premiums and accelerated amortization of
deferred financing costs and debt discounts and premiums. The
loss was recognized in interest expense in the consolidated
statement of income.
MEDTRONIC PLC 2021 Form 10-K 77
PART II
Item 8 Financial Statements and Supplementary Data
In September 2020, Medtronic Luxco issued an additional six
tranches of Euro-denominated Senior Notes with an aggregate
principal of 6.3 billion, with maturities ranging from fiscal year
2023 to fiscal year 2051, resulting in cash proceeds of
approximately $7.2 billion, net of discounts and issuance costs.
The Company used the net proceeds of the offering to fund the
early redemption of $4.3 billion of Medtronic Inc. and CIFSA
Senior Notes and 1.5 billion of Medtronic Luxco Senior Notes
for $6.3 billion of total consideration in October 2020.
Additionally, the Company used the proceeds to repay its
750 million floating rate senior notes at maturity in March 2021.
The Company recognized a loss on debt extinguishment of
$308 million in fiscal year 2021, which primarily included cash
premiums and accelerated amortization of deferred financing
costs and debt discounts and premiums. The loss was
recognized in interest expense in the consolidated statement of
income.
The Euro-denominated debt issued in June 2019 and
September 2020 is designated as a net investment hedge of
certain of the Company’s European operations. Refer to Note 7
for additional information regarding the net investment hedge.
Term Loan Agreements
On May 12, 2020, Medtronic Luxco entered into a term loan
agreement (Loan Agreement) by and among Medtronic Luxco,
Medtronic plc, Medtronic, Inc., and Mizuho Bank, Ltd. as
administrative agent and as lender. The Loan Agreement
provided an unsecured term loan in an aggregate principal
amount of up to ¥300 billion, with a term of six months and the
option to extend for an additional six months at Medtronic
Luxco’s option. On May 13, 2020, Medtronic Luxco borrowed the
entire amount of the term loan under the Loan Agreement. The
Japanese Yen-denominated debt was designated as a net
investment hedge of certain of our Japanese operations.
Borrowings under the Loan Agreement carried interest at the
TIBOR Rate (as defined in the Loan Agreement) plus a margin of
0.50% per annum. Medtronic plc and Medtronic, Inc. guaranteed
the obligations of Medtronic Luxco under the Loan Agreement.
On November 12, 2020, the Company exercised its option to
extend the term loan for an additional six months. During the
fourth quarter of fiscal year 2021, the Company de-designated
the Yen-denominated debt as a net investment hedge and
repaid the term loan in full, including interest.
Contractual maturities of debt for the next five fiscal years and thereafter, excluding deferred financing costs and debt discount, net, are
as follows:
(in millions)
2022 $11
2023 4,237
2024 6
2025 1,895
2026 2,423
Thereafter 18,016
Total $ 26,588
Financial Instruments Not Measured at Fair
Value
At April 30, 2021, the estimated fair value of the Company’s
Senior Notes was $28.6 billion compared to a principal value of
$26.5 billion. At April 24, 2020 the estimated fair value was
$27.1 billion compared to a principal value of $24.5 billion. There
was no commercial paper outstanding during fiscal year 2021.
The fair value was estimated using quoted market prices for the
publicly registered Senior Notes, which are classified as Level 2
within the fair value hierarchy. The fair values and principal values
consider the terms of the related debt and exclude the impacts
of debt discounts and hedging activity.
7. Derivatives and Currency Exchange Risk Management
The Company uses operational and economic hedges, including
currency exchange rate derivative contracts and interest rate
derivative instruments, to manage the impact of currency
exchange and interest rate changes on earnings and cash flows.
In addition, the Company uses cross currency interest rate
swaps to manage currency risk related to certain debt. In order
to minimize earnings and cash flow volatility resulting from
currency exchange rate changes, the Company enters into
derivative instruments, principally forward currency exchange
rate contracts. These contracts are designed to hedge
anticipated foreign currency transactions and changes in the
value of specific assets and liabilities. At inception of the
contract, the derivative is designated as either a freestanding
derivative or a cash flow hedge. Currencies of our derivative
instruments include the Euro, Japanese Yen, Chinese Yuan, and
others. The Company does not enter into currency exchange
rate derivative contracts for speculative purposes. The gross
notional amount of all currency exchange rate derivative
instruments outstanding was $14.7 billion and $11.9 billion at
April 30, 2021 and April 24, 2020, respectively.
The Company also uses derivative and non-derivative
instruments to manage the impact of currency exchange rate
changes on net investments in foreign currency-denominated
operations. The information that follows explains the various
types of derivatives and financial instruments used by the
Company, reasons the Company uses such instruments, and the
impact such instruments have on the Company’s consolidated
balance sheets and statements of income.
78
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
Freestanding Derivative Contracts
Freestanding derivative contracts are primarily used to offset the
Company’s exposure to the change in value of specific foreign-
currency-denominated assets and liabilities, and to offset
variability of cash flows associated with forecasted transactions
denominated in foreign currencies. The gross notional amount
of the Company’s freestanding currency exchange rate
contracts outstanding at April 30, 2021 and April 24, 2020 was
$5.7 billion and $4.9 billion, respectively. The Company’s
freestanding currency exchange rate contracts are not
designated as hedges, and therefore, changes in the value of
these contracts are recognized in earnings, thereby offsetting
the current earnings effect of the related change in value of
foreign-currency-denominated assets, liabilities, and cash flows.
The Company also uses total return swaps to hedge the liability
of a non-qualified, deferred compensation plan. The gross
notional amount of the Company’s total return swaps
outstanding at April 30, 2021 and April 24, 2020 was $243 million
and $181 million, respectively. The Company’s total return swaps
are not designated as hedges, and therefore, changes in the
value of these instruments are recognized in earnings. The cash
flows related to the Company’s freestanding derivative
contracts are reported as operating activities or financing
activities, depending on the nature of the underlying hedged
item, in the consolidated statements of cash flows.
The amounts and classification of the (gains) losses in the consolidated statements of income related to derivative instruments, not
designated as hedging instruments, for fiscal years 2021, 2020, and 2019 were as follows:
Fiscal Year
(in millions) Classification 2021 2020 2019
Currency exchange rate contracts Other operating expense, net $ 247 $ (133) $ (218)
Total return swaps Other operating expense, net (81) 7 (18)
Total $ 166 $ (126) $ (236)
Cash Flow Hedges
Forward contracts designated as cash flow hedges are designed
to hedge the variability of cash flows associated with forecasted
transactions denominated in a foreign currency that will take
place in the future. The gross notional amount of these
contracts, designated as cash flow hedges, outstanding at
April 30, 2021 and April 24, 2020 was $9.0 billion and $7.0 billion,
respectively, and will mature within the subsequent three-year
period. For derivative instruments that are designated and qualify
as a cash flow hedge, the gain or loss on the derivative
instrument is reported as a component of accumulated other
comprehensive loss. The gain or loss on the derivative
instrument is reclassified into earnings and is included in other
operating expense, net or cost of products sold in the
consolidated statements of income in the same period or
periods during which the hedged transaction affects earnings.
Amounts excluded from the measurement of hedge
effectiveness are recognized in earnings in the current period.
The cash flows related to all of the Company’s derivative
instruments designated as cash flow hedges are reported as
operating activities in the consolidated statements of cash flows.
No components of the hedge contracts were excluded in the
measurement of hedge effectiveness, and no forward contracts
designated as cash flow hedges were derecognized or
discontinued during fiscal years 2021, 2020, or 2019.
The amount of the (gains) losses recognized in accumulated other comprehensive loss (AOCI) related to currency exchange rate
contract derivative instruments designated as cash flow hedges for fiscal years 2021, 2020, and 2019 were as follows:
Fiscal Year
(in millions) 2021 2020 2019
Currency exchange rate contracts $ 627 $ (397) $ (615)
MEDTRONIC PLC 2021 Form 10-K 79
PART II
Item 8 Financial Statements and Supplementary Data
The amount of the (gains) losses recognized in the consolidated statements of income related to derivative instruments designated as
cash flow hedges for fiscal years 2021, 2020, and 2019 were as follows:
Fiscal Year
2021 2020 2019
(in millions)
Other
operating
expense, net
Cost of
products
sold
Other
operating
expense, net
Cost of
products sold
Other
operating
expense, net
Cost of
products
sold
Total amounts of income and expense line
items presented in the consolidated
statements of income in which the effects
of cash flow hedges are recorded $ 315 $ 10,483 $ 71 $ 9,424 $ 258 $ 9,155
Currency exchange rate contracts
designated as cash flow hedges:
Amount of (gain) loss reclassified from
AOCI into income (17) 15 (335) (108)
Forecasted Debt Issuance Interest Rate Risk
Forward starting interest rate derivative instruments designated
as cash flow hedges are designed to manage the exposure to
interest rate volatility with regard to future issuances of fixed-
rate debt. The gains or losses on forward starting interest rate
derivative instruments that are designated and qualify as cash
flow hedges are reported as a component of accumulated other
comprehensive loss. Beginning in the period in which the planned
debt issuance occurs and the related derivative instruments are
terminated, the gains or losses are then reclassified into interest
expense over the term of the related debt. For fiscal years 2021,
2020, and 2019, the reclassifications of net (gains) losses on
forward starting interest rate derivative instruments from
accumulated other comprehensive loss to interest expense
were not significant.
At April 30, 2021 and April 24, 2020, the Company had
$253 million in after-tax unrealized losses and $266 million in
after-tax net unrealized gains, respectively, associated with cash
flow hedging instruments recorded in accumulated other
comprehensive loss. The Company expects that $146 million of
after-tax net unrealized losses at April 30, 2021 will be
recognized in the consolidated statements of income over the
next 12 months.
Net Investment Hedges
The Company has designated Euro-denominated debt as a net
investment hedge of certain of its European operations to
manage the exposure to currency and exchange rate
movements for foreign currency-denominated net investments
in foreign operations. At April 30, 2021, the Company had
16.0 billion, or $19.3 billion, of outstanding Euro-denominated
debt designated as a hedge of its net investment in certain of its
European operations, which will mature in fiscal years 2023
through fiscal year 2051.
In February 2021, the Company de-designated ¥300 billion of
outstanding Yen-denominated debt previously designated as a
net investment hedge and concurrently entered into
freestanding forward derivative contracts with a total notional
value of ¥300 billion, or approximately $2.9 billion. These forward
contracts were not designated as hedges. The Company used
the proceeds from these forward derivative contracts to repay
the ¥300 billion of Yen-denominated debt in conjunction with the
maturity of these forward contracts in March and April of 2021.
Additionally, during the first quarter of fiscal year 2020, the
Company entered into and settled forward currency exchange
rate contracts to manage the exposure to exchange rate
movements in anticipation of the issuance of Euro-denominated
senior notes. Certain of these forward currency exchange rate
contracts were designated as a net investment hedge of certain
of the Company’s European operations. These contracts
matured in conjunction with the issuance of the Euro-
denominated debt in the first quarter of fiscal year 2020.
For instruments that are designated and qualify as net
investment hedges, the gains or losses are reported as a
component of accumulated other comprehensive loss. The gains
or losses are reclassified into earnings upon a liquidation event or
deconsolidation of the foreign subsidiary. Amounts excluded
from the assessment of effectiveness are recognized in other
operating expense, net. The cash flows related to the Company’s
derivative instruments designated as net investment hedges are
reported as investing activities in the consolidated statements of
cash flows.
At April 30, 2021 and April 24, 2020, the Company had $1.5 billion
in after-tax unrealized losses, and $236 million in after-tax
unrealized gains associated with net investment hedges
recorded in accumulated other comprehensive loss, respectively.
The Company does not expect any of the after-tax unrealized
losses at April 30, 2021 to be recognized in the consolidated
statements of income over the next 12 months.
The Company did not recognize any gains or losses during fiscal
years 2021, 2020, or 2019 on instruments that no longer qualify
as net investment hedges.
80
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
The amount and classifications of the (gains) losses recognized in the consolidated statements of income for the portion of the net
investment hedges excluded from the measurement of hedge effectiveness were as follows:
Fiscal Year
(in millions) Classification 2021 2020 2019
Net investment hedges Other operating expense, net $ $ (9) $ (12)
The amount of the (gains) losses recognized in AOCI related to instruments designated as net investment hedges for fiscal year 2021,
2020, or 2019 were as follows:
Fiscal Year
(in millions) 2021 2020 2019
Net investment hedges $ (1,694) $ (405) $ (88)
Balance Sheet Presentation
The following tables summarize the balance sheet classification and fair value of derivative instruments included in the consolidated
balance sheets at April 30, 2021 and April 24, 2020. The fair value amounts are presented on a gross basis, and are segregated between
derivatives that are designated and qualify as hedging instruments and those that are not designated and do not qualify as hedging
instruments, and are further segregated by type of contract within those two categories.
April 30, 2021
Derivative Assets Derivative Liabilities
(in millions) Balance Sheet Classification Fair Value Balance Sheet Classification Fair Value
Derivatives designated as hedging instruments
Currency exchange rate contracts Other current assets $ 49 Other accrued expenses $ 190
Currency exchange rate contracts Other assets 22 Other liabilities 94
Total derivatives designated as hedging
instruments 70 285
Derivatives not designated as hedging instruments
Currency exchange rate contracts Other current assets 14 Other accrued expenses 11
Total return swaps Other current assets 18 Other accrued expenses
Total derivatives not designated as hedging
instruments 32 11
Total derivatives $ 102 $ 296
April 24, 2020
Derivative Assets Derivative Liabilities
(in millions) Balance Sheet Classification Fair Value Balance Sheet Classification Fair Value
Derivatives designated as hedging instruments
Currency exchange rate contracts Other current assets $ 271 Other accrued expenses $ 2
Currency exchange rate contracts Other assets 103 Other liabilities 2
Total derivatives designated as hedging
instruments 374 4
Derivatives not designated as hedging instruments
Currency exchange rate contracts Other current assets 25 Other accrued expenses 13
Total return swaps Other current assets Other accrued expenses 25
Cross-currency interest rate contracts Other current assets 3 Other accrued expenses
Total derivatives not designated as hedging
instruments 28 38
Total derivatives $ 402 $ 42
MEDTRONIC PLC 2021 Form 10-K 81
PART II
Item 8 Financial Statements and Supplementary Data
The following table provides information by level for the derivative assets and liabilities that are measured at fair value on a recurring
basis:
April 30, 2021 April 24, 2020
(in millions) Level 1 Level 2 Level 1 Level 2
Derivative assets $ 85 $ 18 $ 399 $ 3
Derivative liabilities 296 17 25
The Company has elected to present the fair value of derivative
assets and liabilities within the consolidated balance sheets on a
gross basis, even when derivative transactions are subject to
master netting arrangements and may otherwise qualify for net
presentation. The cash flows related to collateral posted and
received are reported gross as investing and financing activities,
respectively, in the consolidated statements of cash flows.
The following tables provide information as if the Company had
elected to offset the asset and liability balances of derivative
instruments, netted in accordance with various criteria as
stipulated by the terms of the master netting arrangements with
each of the counterparties. Derivatives not subject to master
netting arrangements are not eligible for net presentation.
April 30, 2021
Gross Amount Not Offset on the
Balance Sheet
(in millions)
Gross Amount of
Recognized Assets
(Liabilities)
Financial
Instruments
Cash Collateral
(Received)
Posted
Net
Amount
Derivative assets:
Currency exchange rate contracts $ 85 $ (83) $ $ 1
Total return swaps 18 18
102 (83) 19
Derivative liabilities:
Currency exchange rate contracts (296) 83 46 (167)
Total $ 193 $ $ 46 $ (148)
April 24, 2020
Gross Amount Not Offset on the
Balance Sheet
(in millions)
Gross Amount of
Recognized Assets
(Liabilities)
Financial
Instruments
Cash Collateral
(Received)
Posted
Net
Amount
Derivative assets:
Currency exchange rate contracts $ 399 $ (17) $ (48) $ 334
Cross-currency interest rate contracts 3 3
402 (17) (48) 337
Derivative liabilities:
Currency exchange rate contracts (17) 17
Total return swaps (25) (25)
(42) 17 (25)
Total $ 360 $ $ (48) $ 312
82 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
Concentrations of Credit Risk
Financial instruments, which potentially subject the Company to
significant concentrations of credit risk, consist principally of
interest-bearing investments, forward exchange derivative
contracts, and trade accounts receivable. Global concentrations
of credit risk with respect to trade accounts receivable are
limited due to the large number of customers and their
dispersion across many geographic areas. The Company
monitors the creditworthiness of its customers to which it grants
credit terms in the normal course of business.
The Company maintains cash and cash equivalents,
investments, and certain other financial instruments (including
currency exchange rate and interest rate derivative contracts)
with various major financial institutions. The Company performs
periodic evaluations of the relative credit standings of these
financial institutions and limits the amount of credit exposure
with any one institution. In addition, the Company has collateral
credit agreements with its primary derivatives counterparties.
Under these agreements, either party is required to post eligible
collateral when the market value of transactions covered by the
agreement exceeds specific thresholds, thus limiting credit
exposure for both parties. As of April 30, 2021, the Company
posted net cash collateral of $46 million to its counterparties. As
of April 24, 2020, the Company received net cash collateral of
$48 million from its counterparties. Cash collateral posted is
recorded as a reduction in cash and cash equivalents, with the
offset recorded as an increase in other current assets in the
consolidated balance sheets. Cash collateral received is
recorded as an increase in cash and cash equivalents with the
offset recorded in other accrued expenses in the consolidated
balance sheets.
8. Inventories
Inventory balances, net of reserves, were as follows:
(in millions) April 30, 2021 April 24, 2020
Finished goods $ 2,906 $ 2,874
Work-in-process 611 608
Raw materials 796 747
Total $ 4,313 $ 4,229
9. Goodwill and Other Intangible Assets
Goodwill
The following table presents the changes in the carrying amount of goodwill by segment:
(in millions) Cardiovascular Medical Surgical Neuroscience Diabetes Total
April 26, 2019 $ 6,854 $ 20,381 $ 10,821 $ 1,903 $ 39,959
Goodwill as a result of acquisitions 19 227 71 16 333
Purchase accounting adjustments 7 2 120 (5) 124
Currency translation and other (49) (434) (92) (575)
April 24, 2020 6,831 20,176 10,920 1,914 39,841
Goodwill as a result of acquisitions 248 12 210 346 816
Purchase accounting adjustments (2) (5) 3 (4) (8)
Currency translation and other 132 1,012 167 1 1,312
April 30, 2021 $ 7,209 $ 21,195 $ 11,300 $ 2,257 $ 41,961
The Company did not recognize any goodwill impairments during fiscal years 2021, 2020, or 2019.
MEDTRONIC PLC 2021 Form 10-K 83
PART II
Item 8 Financial Statements and Supplementary Data
Intangible Assets
The following table presents the gross carrying amount and accumulated amortization of intangible assets:
April 30, 2021 April 24, 2020
(in millions)
Gross Carrying
Amount
Accumulated
Amortization
Gross Carrying
Amount
Accumulated
Amortization
Definite-lived:
Customer-related $ 17,036 $ (6,058) $ 16,963 $ (5,065)
Purchased technology and patents 11,286 (5,156) 10,742 (4,354)
Trademarks and tradenames 475 (251) 464 (232)
Other 82 (68) 75 (53)
Total $ 28,879 $ (11,533) $ 28,244 $ (9,704)
Indefinite-lived:
IPR&D $ 394 $ $ 523 $
During fiscal year 2021, the Company recognized $30 million of
definite-lived intangible asset charges in connection with the
abandonment of certain intangible assets within the
Neuroscience segment. During fiscal year 2020, the Company
recognized $37 million of definite-lived intangible asset charges,
including $33 million and $4 million recognized in connection with
business exits in the Neuroscience and Cardiovascular
segments, respectively. During fiscal year 2019, the Company
recognized $87 million of definite-lived intangible asset charges,
including $61 million and $26 million recognized in connection
with business exits in the Cardiovascular and Neuroscience
segments, respectively. Definite-lived intangible asset charges
are recognized in other operating expense, net in the
consolidated statements of income.
During fiscal year 2021, the Company recognized $45 million of
indefinite-lived intangible asset charges related to the
abandonment of certain IPR&D projects in the Neuroscience
segment. During fiscal year 2020, the Company recognized
$35 million of indefinite-lived intangible asset charges, including
$25 million relating to a partial impairment of an IPR&D project
within the Neuroscience segment and $10 million in connection
with the discontinuation of an IPR&D project within the
Cardiovascular segment. During fiscal year 2019, the Company
recognized $30 million of indefinite-lived intangible asset
charges, including $11 million in connection with a business exit
in the Neuroscience segment, and $10 million and $9 million in
connection with the discontinuation of certain IPR&D projects
within the Medical Surgical and Cardiovascular segments,
respectively. Indefinite-lived intangible asset charges are
recognized in other operating expense, net in the consolidated
statements of income. Due to the nature of IPR&D projects, the
Company may experience future delays or failures to obtain
regulatory approvals to conduct clinical trials, failures of such
clinical trials, delays or failures to obtain required market
clearances, other failures to achieve a commercially viable
product, or the discontinuation of certain projects, and as a
result, may recognize impairment losses in the future.
Amortization
Intangible asset amortization expense was $1.8 billion for fiscal
years 2021, 2020 and 2019. Estimated aggregate amortization
expense by fiscal year based on the current carrying value and
remaining estimated useful lives of definite-lived intangible
assets at April 30, 2021, excluding any possible future
amortization associated with acquired IPR&D which has not met
technological feasibility, is as follows:
(in millions)
Amortization
Expense
2022 $ 1,758
2023 1,693
2024 1,662
2025 1,635
2026 1,623
84 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
10. Property, Plant, and Equipment
Property, plant, and equipment balances and corresponding estimated useful lives were as follows:
(in millions) April 30, 2021 April 24, 2020
Estimated Useful Lives
(in years)
Equipment $ 6,308 $ 5,859 Generally 2-7, up to 15
Computer software 2,346 2,131 Up to 5
Land and land improvements 178 175 Up to 20
Buildings and leasehold improvements 2,370 2,277 Up to 40
Construction in progress 1,498 1,202
Property, plant, and equipment 12,700 11,644
Less: Accumulated depreciation (7,479) (6,816)
Property, plant, and equipment, net $ 5,221 $ 4,828
Depreciation expense of $919 million, $907 million, and $895 million was recognized in fiscal years 2021, 2020, and 2019, respectively.
11. Shareholders’ Equity
Share Capital
Medtronic plc is authorized to issue 2.6 billion Ordinary Shares,
$0.0001 par value; 40 thousand Euro Deferred Shares, 1.00 par
value; 127.5 million Preferred Shares, $0.20 par value; and
500 thousand A Preferred Shares, $1.00 par value.
Euro Deferred Shares
The authorized share capital of the Company includes
40 thousand Euro Deferred Shares, with a par value of 1.00 per
share. At April 30, 2021, no Euro Deferred Shares were issued or
outstanding.
Preferred Shares
The authorized share capital of the Company includes
127.5 million of Preferred Shares, with a par value of $0.20 per
share. At April 30, 2021, no Preferred Shares were issued or
outstanding.
A Preferred Shares
The authorized share capital of the Company includes
500 thousand A Preferred Shares, with a par value of $1.00 per
share. At April 30, 2021, 1,872 A Preferred Shares were
outstanding. The holders of A Preferred Shares are entitled to
payment of dividends prior to any other class of shares in the
Company equal to twice the dividend to be paid per Company
ordinary share. On a return of assets, whether on liquidation or
otherwise, the A Preferred Shares are entitled to repayment of
the capital paid up thereon in priority to any repayment of capital
to the holders of any other shares and the holders of the A
Preferred Shares shall not be entitled to any further participation
in the assets or profits of the Company. The holders of the A
Preferred Shares are not entitled to receive notice of, nor to
attend, speak, or vote at any general meeting of the Company.
Dividends
The timing, declaration, and payment of future dividends to
holders of the Company’s ordinary and A Preferred shares falls
within the discretion of the Company’s Board of Directors and
depends upon many factors, including the statutory
requirements of Irish law, the Company’s earnings and financial
condition, the capital requirements of the Company’s
businesses, industry practice and any other factors the Board of
Directors deems relevant.
Ordinary Share Repurchase Program
Shares are repurchased from time to time to support the
Company’s stock-based compensation programs and to return
capital to shareholders. During fiscal years 2021 and 2020, the
Company repurchased approximately 4 million and 12 million
shares, respectively, at an average price of $126.80 and $106.22,
respectively.
In March 2019, the Company’s Board of Directors authorized
$6.0 billion for repurchase of the Company’s ordinary shares.
There is no specific time-period associated with these
repurchase authorizations. At April 30, 2021, the Company had
used $608 million of the $6.0 billion authorized under the
repurchase program, leaving approximately $5.4 billion available
for future repurchases. The Company accounts for repurchases
of ordinary shares using the par value method and shares
repurchased are cancelled.
MEDTRONIC PLC 2021 Form 10-K 85
PART II
Item 8 Financial Statements and Supplementary Data
12. Stock Purchase and Award Plans
In fiscal year 2021, the Company granted stock awards under the
Medtronic plc 2013 Plan (2013 Plan). The 2013 Plan provides for
the grant of non-qualified and incentive stock options, stock
appreciation rights, restricted stock, restricted stock units,
performance awards, and other stock and cash-based awards.
At April 30, 2021, there were approximately 26 million shares
available for future grants under the 2013 Plan.
Stock-Based Compensation Expense
The following table presents the components and classification of stock-based compensation expense recognized for stock options,
restricted stock, performance share units, and employee stock purchase plan (ESPP) in fiscal years 2021, 2020, and 2019:
Fiscal Year
(in millions) 2021 2020 2019
Stock options $72$61$72
Restricted stock 185 205 189
Performance share units 49
Employee stock purchase plan 38 31 29
Total stock-based compensation expense $ 344 $ 297 $ 290
Cost of products sold $ 35 $ 28 $ 30
Research and development expense 38 36 36
Selling, general, and administrative expense 272 233 224
Total stock-based compensation expense 344 297 290
Income tax benefits (59) (51) (54)
Total stock-based compensation expense, net of tax $ 285 $ 246 $ 236
Stock Options
Options are granted at the exercise price, which is equal to the
closing price of the Company’s ordinary shares on the grant
date. The majority of the Company’s options are non-qualified
options with a 10-year life and a 4-year ratable vesting term. The
Company uses the Black-Scholes option pricing model (Black-
Scholes model) to determine the fair value of stock options at
the grant date. The fair value of stock options under the Black-
Scholes model requires management to make assumptions
regarding projected employee stock option exercise behaviors,
risk-free interest rates, volatility of the Company’s stock price,
and expected dividends.
The following table provides the weighted average fair value of options granted to employees and the related assumptions used in the
Black-Scholes model:
Fiscal Year
2021 2020 2019
Weighted average fair value of options granted $ 16.15 $ 15.49 $ 14.77
Assumptions used:
Expected life (years) 6.0 6.1 6.1
Risk-free interest rate 0.33% 1.88% 2.90%
Volatility 24.17% 17.97% 17.77%
Dividend yield 2.36% 2.09% 2.25%
86 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
The following table summarizes stock option activity during fiscal year 2021:
Options
(in thousands)
Wtd. Avg.
Exercise
Price
Wtd. Avg.
Remaining
Contractual
Term
(in years)
Aggregate
Intrinsic Value
(in millions)
Outstanding at April 24, 2020 27,068 $ 78.70
Granted 6,182 98.16
Exercised (4,370) 66.91
Expired/Forfeited (908) 95.54
Outstanding at April 30, 2021 27,972 84.38 5.7 $ 1,302
Expected to vest at April 30, 2021 9,184 97.01 8.5 311
Exercisable at April 30, 2021 18,149 77.48 4.2 970
The following table summarizes the total cash received from the issuance of new shares upon stock option award exercises, the total
intrinsic value of options exercised, and the related tax benefit during fiscal years 2021, 2020, and 2019:
Fiscal Year
(in millions) 2021 2020 2019
Cash proceeds from options exercised $ 277 $ 484 $ 825
Intrinsic value of options exercised 205 349 383
Tax benefit related to options exercised 47 75 78
Unrecognized compensation expense related to outstanding stock options at April 30, 2021 was $76 million and is expected to be
recognized over a weighted average period of 2.6 years.
Restricted Stock
Restricted stock units are expensed over the vesting period and
are subject to forfeiture if employment terminates prior to the
lapse of the restrictions. The expense recognized for restricted
stock units is equal to the grant date fair value, which is equal to
the closing stock price on the date of grant. Beginning in fiscal
year 2018, restricted stock units have a 4-year ratable vesting
term. Restricted stock units issued prior to fiscal year 2018 cliff
vest after four years. The Company also grants shares of
performance-based restricted stock units that typically cliff vest
after three years only if the Company has also achieved certain
performance objectives. Performance awards are expensed
over the performance period based on the probability of
achieving the performance objectives. Restricted stock units are
not considered issued or outstanding ordinary shares of the
Company. Dividend equivalent units are accumulated on
restricted stock units during the vesting period.
The following table summarizes restricted stock activity during fiscal year 2021:
Units
(in thousands)
Wtd. Avg.
Grant
Price
Nonvested at April 24, 2020 7,625 $ 92.52
Granted 2,193 99.48
Vested (3,228) 86.89
Forfeited (610) 95.79
Nonvested at April 30, 2021 5,980 97.66
The following table summarizes the weighted-average grant date fair value of restricted stock granted, total fair value of restricted stock
vested and related tax benefit during fiscal years 2021, 2020, and 2019:
Fiscal Year
(in millions, except per share data) 2021 2020 2019
Weighted-average grant-date fair value per restricted stock $ 99.48 $ 103.52 $ 88.78
Fair value of restricted stock vested 280 242 174
Tax benefit related to restricted stock vested 65 62 45
Unrecognized compensation expense related to restricted stock as of April 30, 2021 was $316 million and is expected to be recognized
over a weighted average period of 2.4 years.
MEDTRONIC PLC 2021 Form 10-K 87
PART II
Item 8 Financial Statements and Supplementary Data
Performance Share Units
Beginning in fiscal year 2021, the Company granted performance
share units to officers and key employees. Performance share
units typically cliff vest after three years. The awards include
three metrics: relative total shareholder return (rTSR), revenue
growth, and return on investor capital (ROIC). rTSR is considered
a market condition metric, and the expense is determined at the
grant date and will not be adjusted even if the market condition is
not met. Revenue growth and ROIC are considered performance
metrics, and the expense is recorded over the performance
period, which will be reassessed each reporting period based on
the probability of achieving the various performance conditions.
The number of shares earned at the end of the three-year
period will vary, based on only actual performance, from 0% to
200% of the target number of performance share units granted.
Performance share units are subject to forfeiture if employment
terminates prior to the lapse of the restrictions. Performance
share units are not considered issued or outstanding ordinary
shares of the Company. Dividend equivalent units are
accumulated on performance share units for each component
of the award during the vesting period.
The Company calculates the fair value of the performance share
units for each component individually. The fair value of the rTSR
metric will be determined using the Monte Carlo valuation model.
The fair value of the revenue growth and ROIC metrics are equal
to the closing stock price on the grant date.
The following table summarizes performance share unit activity during fiscal year 2021:
Units
(in thousands)
Wtd. Avg.
Grant
Price
Nonvested at April 24, 2020 —$
Granted 854 129.04
Forfeited (25) 128.51
Nonvested at April 30, 2021 828 129.05
The following table summarizes the weighted-average grant date fair value of performance share units granted, total fair value of
performance share units vested and related tax benefit during fiscal year 2021:
Fiscal Year
(in millions, except per share data) 2021
Weighted-average grant-date fair value per performance share units $ 129.04
Fair value of performance share units vested
Tax benefit related to performance share units vested
Unrecognized compensation expense related to performance
share units as of April 30, 2021 was $57 million and is expected to
be recognized over a weighted average period of 2.2 years.
Employees Stock Purchase Plan
The Medtronic plc Amended and Restated 2014 Employees
Stock Purchase Plan allows participating employees to purchase
the Company’s ordinary shares at a discount through payroll
deductions. The expense recognized for shares purchased
under the Company’s ESPP is equal to the 15 percent discount
the employee receives. Employees purchased 2 million shares at
an average price of $90.16 per share in fiscal year 2021. At
April 30, 2021, approximately 9 million ordinary shares were
available for future purchase under the ESPP.
13. Income Taxes
The income tax provision (benefit) is based on income before income taxes reported for financial statement purposes. The components
of income before income taxes, based on tax jurisdiction, are as follows:
Fiscal Year
(in millions) 2021 2020 2019
U.S. $ (358) $ 466 $ 877
International 4,253 3,589 4,320
Income before income taxes $ 3,895 $ 4,055 $ 5,197
88 MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
The income tax provision (benefit) consists of the following:
Fiscal Year
(in millions) 2021 2020 2019
Current tax expense:
U.S. $ 287 $ 151 $ 579
International 439 375 406
Total current tax expense 726 526 985
Deferred tax (benefit) expense:
U.S. (625) (138) (310)
International 165 (1,139) (128)
Net deferred tax benefit (461) (1,277) (438)
Income tax provision (benefit) $ 265 $ (751) $ 547
Tax assets (liabilities), shown before jurisdictional netting of deferred tax assets (liabilities), are comprised of the following:
(in millions) April 30, 2021 April 24, 2020
Deferred tax assets:
Net operating loss, capital loss, and credit carryforwards $ 6,114 $ 6,432
Capitalization of research and development 408
Other accrued liabilities 442 390
Accrued compensation 411 285
Pension and post-retirement benefits 234 350
Stock-based compensation 132 136
Inventory 164 191
Lease obligations 106 101
Federal and state benefit on uncertain tax positions 55 96
Interest limitation 352 266
Other 336 308
Gross deferred tax assets 8,754 8,555
Valuation allowance (5,822) (5,482)
Total deferred tax assets 2,932 3,073
Deferred tax liabilities:
Intangible assets (320) (1,017)
Realized loss on derivative financial instruments (75) (65)
Right of use leases (102) (97)
Unrealized gain on available-for-sale securities and derivative financial instruments (16) (12)
Accumulated depreciation (151) (87)
Outside basis difference of subsidiaries (101) (77)
Other (81) (110)
Total deferred tax liabilities (846) (1,465)
Prepaid income taxes 458 449
Income tax receivables 353 381
Tax assets, net $ 2,897 $ 2,438
Reported as (after valuation allowance and jurisdictional netting):
Other current assets $ 756 $ 780
Tax assets 3,169 2,832
Deferred tax liabilities (1,028) (1,174)
Tax assets, net $ 2,897 $ 2,438
MEDTRONIC PLC 2021 Form 10-K 89
PART II
Item 8 Financial Statements and Supplementary Data
No deferred taxes have been provided on the approximately
$74.2 billion and $69.9 billion of undistributed earnings of the
Company’s subsidiaries at April 30, 2021 and April 24, 2020,
respectively, since these earnings have been, and under current
plans will continue to be, permanently reinvested in these
subsidiaries. Due to the number of legal entities and jurisdictions
involved, the complexity of the legal entity structure of the
Company, and the complexity of the tax laws in the relevant
jurisdictions, the Company believes it is not practicable to
estimate, within any reasonable range, the amount of additional
taxes which may be payable upon distribution of these
undistributed earnings.
At April 30, 2021, the Company had approximately $25.2 billion
of net operating loss carryforwards in certain non-U.S.
jurisdictions, of which $20.2 billion have no expiration, and the
remaining $5.0 billion will expire during fiscal years 2022 through
2041. Included in these net operating loss carryforwards are
$18.5 billion of net operating losses related to a subsidiary of the
Company, substantially all of which were recorded in fiscal year
2008 as a result of the receipt of a favorable tax ruling from
certain non-U.S. taxing authorities. The Company has recorded a
full valuation allowance against these net operating losses, as
management does not believe that it is more likely than not that
these net operating losses will be utilized. Certain of the
remaining non-U.S. net operating loss carryforwards of
$6.7 billion have a valuation allowance recorded against the
carryforwards, as management does not believe that it is more
likely than not that these net operating losses will be utilized.
At April 30, 2021, the Company had $361 million of U.S. federal
net operating loss carryforwards, of which $81 million have no
expiration. The remaining loss carryforwards will expire during
fiscal years 2022 through 2038. For U.S. state purposes, the
Company had $1.4 billion of net operating loss carryforwards at
April 30, 2021, $57 million of which have no expiration. The
remaining U.S. state loss carryforwards will expire during fiscal
years 2022 through 2041.
At April 30, 2021, the Company also had $270 million of tax
credits available to reduce future income taxes payable, of which
$107 million have no expiration. The remaining credits will expire
during fiscal years 2022 through 2041.
The Company has established valuation allowances of $5.8 billion
and $5.5 billion at April 30, 2021 and April 24, 2020, respectively,
primarily related to the uncertainty of the utilization of certain
deferred tax assets which are primarily comprised of tax loss and
credit carryforwards in various jurisdictions. The increase in the
valuation allowance during fiscal year 2021 is primarily related to
the generation of certain net operating losses and the effects of
currency fluctuations. These valuation allowances would result in
a reduction to the income tax provision in the consolidated
statements of income if they are ultimately not required.
The Company’s effective income tax rate varied from the U.S. federal statutory tax rate as follows:
Fiscal Year
2021 2020 2019
U.S. federal statutory tax rate 21.0% 21.0% 21.0%
Increase (decrease) in tax rate resulting from:
U.S. state taxes, net of federal tax benefit (1.1) 0.5 0.9
Research and development credit (2.3) (2.1) (1.2)
Puerto Rico Excise Tax (2.0) (1.5) (1.6)
International (12.6) (10.0) (10.7)
U.S. Tax Reform ——0.2
Stock based compensation (0.8) (1.5) (1.0)
Other, net 0.9 0.4 (0.5)
Interest on uncertain tax positions 0.9 1.3 0.9
Base Erosion Anti-Abuse Tax 0.5 2.6 0.1
Foreign Derived Intangible Income Benefit (1.9) (1.2) (0.6)
Divestiture-related (0.4)
Certain tax adjustments (1.0) (30.8) (0.6)
Legal entity restructuring 1.8
U.S. tax on foreign earnings 3.4 2.8 4.0
Effective tax rate 6.8% (18.5)% 10.5%
During fiscal year 2021, the net benefit from certain tax
adjustments of $41 million, recognized in income tax provision
(benefit) in the consolidated statements of income, included the
following:
A net benefit of $106 million associated with the resolution of
an audit at the IRS Appellate level for fiscal years 2012, 2013,
and 2014. The issues resolved relate to the utilization of
certain net operating losses and the allocation of income
between Medtronic, Inc. and its wholly owned subsidiary
operating in Puerto Rico for businesses that are not the
subject of the U.S. Tax Court Case for fiscal years 2005 and
2006.
90
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
A net cost of $73 million related to a tax basis adjustment of
previously established deferred tax assets from intercompany
intellectual property transactions. The cumulative amount of
deferred tax benefit previously recognized from intercompany
intellectual property transactions and recorded as Certain Tax
Adjustments is $1.5 billion. The corresponding deferred tax
assets will be amortized over a period of approximately 20
years.
A cost of $50 million associated with the amortization of the
previously established deferred tax assets from intercompany
intellectual property transactions.
A net cost of $25 million associated with an internal
restructuring and intercompany sale of assets.
A benefit of $83 million related to the capitalization of certain
research and development costs for U.S. income tax purposes
and the establishment of a deferred tax asset at the U.S.
federal statutory tax rate.
During fiscal year 2020, the net benefit from certain tax
adjustments of $1.2 billion, recognized in income tax provision
(benefit) in the consolidated statements of income, included the
following:
A net benefit of $63 million related to the finalization of certain
state tax impacts from U.S. Tax Reform, and the issuance of
certain final U.S. Treasury Regulations associated with U.S. Tax
Reform. The primary impact of these regulations resulted in
the Company re-establishing its permanently reinvested
assertion on certain foreign earnings and reversing the
previously accrued tax liability. This benefit was partially offset
by additional tax associated with a previously executed internal
reorganization of certain foreign subsidiaries.
A benefit of $252 million related to tax legislative changes in
Switzerland, which abolished certain preferential tax regimes
the Company benefited from and replaced them with a new
set of internationally accepted measures. The legislation
provided for higher effective tax rates but allowed for a
transitional period whereby an amortizable asset was created
for Swiss federal income tax purposes that will be amortized
and deducted over a 10-year period.
A benefit of $658 million related to the release of a valuation
allowance previously recorded against certain net operating
losses. Luxembourg enacted tax legislation during the year
requiring the Company to reassess the realizability of certain
net operating losses. The Company evaluated both the
positive and negative evidence and released valuation
allowance equal to the expected benefit from the utilization of
certain net operating losses in connection with a planned
intercompany sale of intellectual property.
A benefit of $269 million associated with the intercompany
sale of intellectual property and the establishment of a
deferred tax asset.
During fiscal year 2019, the net benefit from certain tax
adjustments of $40 million, recognized in income tax provision
(benefit) in the consolidated statements of income, included the
following:
A net benefit of $30 million associated with the finalization of
the transition tax liability and the Tax Act impact to deferred
tax assets, liabilities, and valuation allowances.
A charge of $42 million related to the recognition of a prepaid
tax expense resulting from the reduction in the U.S. statutory
tax rate under the Tax Act and the current year sale of U.S.
manufactured inventory held as of April 27, 2018.
A benefit of $32 million related to intercompany legal entity
restructuring.
A net benefit of $20 million with the finalization of certain
income tax aspects of the divestiture of the Patient Care,
Deep Vein Thrombosis, and Nutritional Insufficiency
businesses.
Currently, the Company’s operations in Puerto Rico, Singapore,
Dominican Republic, Costa Rica, and China have various tax
holidays and tax incentive grants. The tax reductions as
compared to the local statutory rate favorably impacted
earnings by $301 million, $231 million, and $437 million in fiscal
years 2021, 2020, and 2019, respectively, and diluted earnings
per share by $0.22, $0.17, and $0.32 in fiscal years 2021, 2020,
and 2019, respectively. The tax holidays are conditional upon the
Company meeting certain thresholds required under statutory
law. The tax incentive grants, unless extended, will expire
between fiscal years 2022 and 2030. The Company’s historical
practice has been to renew, extend, or obtain new tax incentive
grants upon expiration of existing tax incentive grants. If the
Company is not able to renew, extend, or obtain new tax
incentive grants, the expiration of existing tax incentive grants
could have a material impact on the Company’s financial results
in future periods. The tax incentive grants which expired during
fiscal year 2021 did not have a material impact on the Company’s
consolidated financial statements.
MEDTRONIC PLC 2021 Form 10-K 91
PART II
Item 8 Financial Statements and Supplementary Data
The Company had $1.7 billion, $1.9 billion, and $1.8 billion of gross unrecognized tax benefits at April 30, 2021, April 24, 2020, and
April 26, 2019, respectively. A reconciliation of the beginning and ending amount of unrecognized tax benefits for fiscal years 2021, 2020,
and 2019 is as follows:
Fiscal Year
(in millions) 2021 2020 2019
Gross unrecognized tax benefits at beginning of fiscal year $ 1,862 $ 1,836 $ 1,727
Gross increases:
Prior year tax positions 88 12 34
Current year tax positions 62 55 109
Gross decreases:
Prior year tax positions (106) (9) (14)
Settlements (216) (5)
Statute of limitation lapses (21) (27) (20)
Gross unrecognized tax benefits at end of fiscal year 1,668 1,862 1,836
Cash advance paid to taxing authorities (859) (859) (859)
Gross unrecognized tax benefits at end of fiscal year,
net of cash advance $ 809 $ 1,003 $ 977
If all of the Company’s unrecognized tax benefits at April 30,
2021, April 24, 2020, and April 26, 2019 were recognized,
$1.6 billion, $1.8 billion, and $1.8 billion would impact the
Company’s effective tax rate, respectively. Although the
Company believes that it has adequately provided for liabilities
resulting from tax assessments by taxing authorities, positions
taken by these tax authorities could have a material impact on
the Company’s effective tax rate in future periods. The Company
has recorded gross unrecognized tax benefits, net of cash
advance, of $809 million as a noncurrent liability. The Company
estimates that within the next 12 months it is reasonably
possible that its uncertain tax positions excluding interest, could
decrease by as much as $14 million, net as a result of statute of
limitation lapses.
The Company recognizes interest and penalties related to
income tax matters in income tax provision (benefit) in the
consolidated statements of income and records the liability in
the current or noncurrent accrued income taxes in the
consolidated balance sheets, as appropriate. The Company had
$99 million, $225 million, and $172 million of accrued gross
interest and penalties at April 30, 2021, April 24, 2020, and
April 26, 2019, respectively. During fiscal years 2021, 2020, and
2019, the Company recognized gross interest income of
$44 million, expense of $53 million, and expense of $48 million,
respectively, in income tax provision (benefit) in the consolidated
statements of income.
The Company reserves for uncertain tax positions related to
unresolved matters with the IRS and other taxing authorities.
These reserves are subject to a high degree of estimation and
management judgment. Resolution of these significant
unresolved matters, or positions taken by the IRS or other tax
authorities during future tax audits, could have a material impact
on the Company’s financial results in future periods. The
Company continues to believe that its reserves for uncertain tax
positions are appropriate and that it has meritorious defenses
for its tax filings and will vigorously defend them during the audit
process, appellate process, and through litigation in courts, as
necessary.
92
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
The major tax jurisdictions where the Company conducts business which remain subject to examination are as follows:
Jurisdiction Earliest Year Open
United States - federal and state 2005
Australia 2016
Brazil 2016
Canada 2013
China 2015
Costa Rica 2017
Dominican Republic 2018
France 2016
Germany 2014
India 2002
Ireland 2012
Israel 2010
Italy 2005
Japan 2017
Korea 2017
Luxembourg 2015
Mexico 2007
Puerto Rico 2011
Singapore 2016
Switzerland 2010
United Kingdom 2017
See Note 18 for additional information regarding the status of current tax audits and proceedings.
14. Earnings Per Share
Earnings per share is calculated using the two-class method, as
the Company’s A Preferred Shares are considered participating
securities. Accordingly, earnings are allocated to both ordinary
shares and participating securities in determining earnings per
ordinary share. Due to the limited number of A Preferred Shares
outstanding, this allocation had no effect on the ordinary
earnings per share; therefore, it is not presented below. Basic
earnings per share is computed based on the weighted average
number of ordinary shares outstanding. Diluted earnings per
share is computed based on the weighted number of ordinary
shares outstanding, increased by the number of additional
shares that would have been outstanding had the potentially
dilutive ordinary shares been issued, and reduced by the number
of shares the Company could have repurchased with the
proceeds from issuance of the potentially dilutive shares.
Potentially dilutive ordinary shares include stock-based awards
granted under stock-based compensation plans and shares
committed to be purchased under the employee stock purchase
plan.
MEDTRONIC PLC 2021 Form 10-K 93
PART II
Item 8 Financial Statements and Supplementary Data
The table below sets forth the computation of basic and diluted earnings per share:
Fiscal Year
(in millions, except per share data) 2021 2020 2019
Numerator:
Net income attributable to ordinary shareholders $ 3,606 $ 4,789 $ 4,631
Denominator:
Basic – weighted average shares outstanding 1,344.9 1,340.7 1,346.4
Effect of dilutive securities:
Employee stock options 6.6 7.2 7.6
Employee restricted stock units 2.1 2.8 3.2
Other 0.5 0.4 0.3
Diluted – weighted average shares outstanding 1,354.0 1,351.1 1,357.5
Basic earnings per share $ 2.68 $ 3.57 $ 3.44
Diluted earnings per share $ 2.66 $ 3.54 $ 3.41
The calculation of weighted average diluted shares outstanding excludes options to purchase approximately 4 million, 4 million, and
7 million ordinary shares in fiscal years 2021, 2020, and 2019, respectively, because their effect would have been anti-dilutive on the
Company’s earnings per share.
15. Retirement Benefit Plans
The Company sponsors various retirement benefit plans,
including defined benefit pension plans, post-retirement medical
plans, defined contribution savings plans, and termination
indemnity plans, covering substantially all U.S. employees and
many employees outside the U.S. The net expense related to
these plans was $668 million, $467 million, and $539 million in
fiscal years 2021, 2020, and 2019, respectively.
In the U.S., the Company maintain qualified pension plans
designed to provide guaranteed minimum retirement benefits to
all eligible U.S. participants. Pension coverage for non-U.S.
employees is provided, to the extent deemed appropriate,
through separate plans. In addition to the benefits provided
under the qualified pension plan, retirement benefits associated
with wages in excess of the IRS allowable limits are provided to
certain employees under a non-qualified plan. U.S. and Puerto
Rico employees are also eligible to receive a medical benefit
component, in addition to normal retirement benefits, through
the Company’s post-retirement benefits.
At April 30, 2021 and April 24, 2020, the net underfunded status
of the Company’s benefit plans was $705 million and $1.4 billion,
respectively.
During fiscal year 2021, as part of the Simplification restructuring
program, the Company offered certain eligible U.S. employees
voluntary early retirement packages, resulting in incremental
expense of $97 million recognized. Of this amount, $73 million
related to U.S. pension benefits, $11 million related to defined
contribution plans, $11 million related to U.S. post-retirement
benefits, and $2 million related to cash payments and
administrative fees. See Note 4 for additional information on the
Simplification restructuring program.
As of April 24, 2020, the Company announced the freezing of
U.S. pension benefits beginning in 2027. Employees will continue
to earn benefits as required by the plan until April 30, 2027, after
which date benefits will no longer be earned and employees will
earn benefits under a new defined contribution structure. The
Company recognized curtailment benefits of $94 million in fiscal
year 2020 as a result of this change.
94
MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
Defined Benefit Pension Plans
The change in benefit obligation and funded status of the Company’s U.S. and Non-U.S. pension benefits are as follows:
U.S. Pension Benefits Non-U.S. Pension Benefits
Fiscal Year Fiscal Year
(in millions) 2021 2020 2021 2020
Accumulated benefit obligation at end of year: $ 3,786 $ 3,440 $ 2,035 $ 1,785
Change in projected benefit obligation:
Projected benefit obligation at beginning of year $ 3,723 $ 3,404 $ 2,024 $ 1,832
Service cost 106 106 70 59
Interest cost 109 126 28 28
Employee contributions 12 11
Plan curtailments and settlements (94) (4) (2)
Actuarial loss
(1)
99 300 6 180
Benefits paid (129) (111) (41) (55)
Special termination benefits 73
Currency exchange rate changes and other (8) 200 (29)
Projected benefit obligation at end of year $ 3,979 $ 3,723 $ 2,294 $ 2,024
Change in plan assets:
Fair value of plan assets at beginning of year $ 2,982 $ 2,728 $ 1,404 $ 1,409
Actual return on plan assets 715 (72) 232 2
Employer contributions 95 444 149 54
Employee contributions 12 11
Plan settlements (4) (2)
Benefits paid (129) (111) (41) (55)
Currency exchange rate changes and other (7) 149 (15)
Fair value of plan assets at end of year $ 3,660 $ 2,982 $ 1,900 $ 1,404
Funded status at end of year:
Fair value of plan assets $ 3,660 $ 2,982 $ 1,900 $ 1,404
Benefit obligations 3,979 3,723 2,294 2,024
Underfunded status of the plans (319) (741) (394) (620)
Recognized liability $ (319) $ (741) $ (394) $ (620)
Amounts recognized on the consolidated
balance sheets consist of:
Non-current assets $ 110 $ $ 48 $ 7
Current liabilities (20) (17) (6) (6)
Non-current liabilities (408) (724) (436) (621)
Recognized liability $ (319) $ (741) $ (394) $ (620)
Amounts recognized in accumulated other
comprehensive loss:
Prior service cost $ $ 1 $ (6) $ 7
Net actuarial loss 1,220 1,662 530 663
Ending balance $ 1,220 $ 1,663 $ 524 $ 670
(1) Actuarial gains and losses result from changes in actuarial assumptions (such as changes in the discount rate and revised mortality rates). The
actuarial losses in fiscal years 2021 and 2020 were primarily related to decreases in discount rates.
MEDTRONIC PLC 2021 Form 10-K 95
PART II
Item 8 Financial Statements and Supplementary Data
In certain countries outside the U.S., fully funding pension plans is not a common practice, as funding provides no income tax benefit.
Consequently, certain pension plans were partially funded at April 30, 2021 and April 24, 2020. U.S. and non-U.S. pension plans with
accumulated benefit obligations in excess of plan assets consist of the following:
Fiscal Year
(in millions) 2021 2020
Accumulated benefit obligation $ 5,089 $ 5,105
Projected benefit obligation 5,198 5,252
Plan assets at fair value 4,561 4,074
U.S. and non-U.S. pension plans with projected benefit obligations in excess of plan assets consist of the following:
Fiscal Year
(in millions) 2021 2020
Projected benefit obligation $ 5,921 $ 5,700
Plan assets at fair value 5,159 4,331
The net periodic benefit cost of the plans includes the following components:
U.S. Pension Benefits Non-U.S. Pension Benefits
Fiscal Year Fiscal Year
(in millions) 2021 2020 2019 2021 2020 2019
Service cost $ 106 $ 106 $ 109 $ 70 $ 59 $ 59
Interest cost 109 126 129 28 28 30
Expected return on plan assets (242) (225) (215) (59) (58) (57)
Amortization of prior service cost 1 1 1 (1) (1) (1)
Amortization of net actuarial loss 69 56 76 25 14 12
Settlement loss (gain) 1 (2)
Special termination benefits 73
Net periodic benefit cost $ 115 $ 64 $ 100 $ 64 $ 42 $ 41
The other changes in plan assets and projected benefit obligations recognized in accumulated other comprehensive loss for fiscal year
2021 are as follows:
(in millions)
U.S. Pension
Benefits
Non-U.S.
Pension
Benefits
Net actuarial gain $ (373) $ (168)
Amortization of prior service cost (1) 1
Amortization and settlement recognition of actuarial loss (69) (26)
Effect of exchange rates —61
Total recognized in accumulated other comprehensive loss $ (443) $ (132)
Total recognized in net periodic benefit cost and accumulated other comprehensive loss $ (328) $ (67)
96 MEDTRONIC PLC 2021 Form 10-K
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Item 8 Financial Statements and Supplementary Data
The actuarial assumptions are as follows:
U.S. Pension Benefits Non-U.S. Pension Benefits
Fiscal Year Fiscal Year
2021 2020 2019 2021 2020 2019
Critical assumptions projected benefit
obligation:
Discount rate 2.80%-3.50% 3.10%-3.70% 3.90%-4.20% 0.30%-13.30% 0.30%-13.30% 0.40%-13.90%
Rate of compensation increase 4.83% 3.90% 3.90% 2.90% 2.91% 2.87%
Critical assumptions net periodic benefit cost:
Discount rate benefit obligation 3.10%-3.70% 3.90%-4.30% 4.20%-4.30% 0.30%-13.90% 0.40%-13.90% 0.50%-11.00%
Discount rate service cost 2.60%-3.90% 3.70%-4.00% 4.10%-4.40% 0.30%-13.90% 0.40%-13.90% 0.50%-11.00%
Discount rate interest cost 2.80%-3.20% 3.50%-4.30% 4.00%-4.10% 0.30%-13.90% 0.40%-13.90% 0.50%-11.00%
Expected return on plan assets 7.50% 7.90% 7.90% 3.78% 4.19% 4.23%
Rate of compensation increase 3.90% 3.90% 3.90% 2.91% 2.87% 2.88%
The Company utilizes a full yield curve approach methodology to
estimate the service and interest cost components of net
periodic pension cost and net periodic post-retirement benefit
cost for the Company’s pension and other post-retirement
benefits. The full yield curve approach applies specific spot rates
along the yield curve to their underlying projected cash flows in
estimation of the cost components. The current yield curves
represent high quality, long-term fixed income instruments.
The expected long-term rate of return on plan assets
assumptions are determined using a building block approach,
considering historical averages and real returns of each asset
class. In certain countries, where historical returns are not
meaningful, consideration is given to local market expectations
of long-term returns.
Retirement Benefit Plan Investment Strategy
The Company sponsors trusts that hold the assets for U.S.
pension plans and other U.S. post-retirement benefit plans,
primarily retiree medical benefits. For investment purposes, the
Medtronic U.S. pension and other U.S. post-retirement benefit
plans employ similar investment strategies with different asset
allocation targets.
The Company has a Qualified Plan Committee (the Plan
Committee) that sets investment guidelines for U.S. pension
plans and other U.S. post-retirement benefit plans with the
assistance of external consultants. These guidelines are
established based on market conditions, risk tolerance, funding
requirements, and expected benefit payments. The Plan
Committee also oversees the investment allocation process,
selects the investment managers, and monitors asset
performance. As pension liabilities are long-term in nature, the
Company employs a long-term total return approach to
maximize the long-term rate of return on plan assets for a
prudent level of risk. An annual analysis on the risk versus the
return of the investment portfolio is conducted to justify the
expected long-term rate of return assumption.
The investment portfolios contain a diversified allocation of
investment categories, including equities, fixed income
securities, hedge funds, and private equity. Securities are also
diversified in terms of domestic and international, short- and
long-term, growth and value styles, large cap and small cap
stocks, and active and passive management.
Outside the U.S., pension plan assets are typically managed by
decentralized fiduciary committees. There is significant variation
in policy asset allocation from country to country. Local
regulations, funding rules, and financial and tax considerations
are part of the funding and investment allocation process in each
country. The weighted average target asset allocations at
April 30, 2021 for the plans are 40% equity securities, 31% debt
securities, and 29% other.
The plans did not hold any investments in the Company’s
ordinary shares at April 30, 2021 or April 24, 2020.
The Company’s U.S. plans target asset allocations at April 30, 2021, compared to the U.S. plans actual asset allocations at April 30, 2021
and April 24, 2020 by asset category, are as follows:
U.S. Plans
Target Allocation Actual Allocation
April 30, 2021 April 30, 2021 April 24, 2020
Asset Category:
Equity securities 34% 39% 39%
Debt securities 51 32 27
Other 15 29 34
Total 100% 100% 100%
MEDTRONIC PLC 2021 Form 10-K 97
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Item 8 Financial Statements and Supplementary Data
Strong performance on equity securities during the fiscal year
resulted in asset allocations different than targets. Management
expects to move the allocations closer to target over the
intermediate term.
Retirement Benefit Plan Asset Fair Values
The following is a description of the valuation methodologies
used for retirement benefit plan assets measured at fair value:
Short-term investments: Valued at the closing price reported in
the active markets in which the individual security is traded.
Mutual funds: Comprised of investments in equity and fixed
income securities held in pooled investment vehicles. The
valuations of mutual funds are based on the respective net asset
values which are determined by the fund daily at market close.
The net asset values are calculated based on the valuation of the
underlying assets which are determined using observable inputs.
The net asset values are publicly reported.
Equity commingled trusts: Comprised of investments in equity
securities held in pooled investment vehicles. The valuations of
equity commingled trusts are based on the respective net asset
values which are determined by the fund daily at market close.
The net asset values are calculated based on the valuation of the
underlying assets which are determined using observable
inputs. The net asset values are not publicly reported, and funds
are valued at the net asset value practical expedient.
Fixed income commingled trusts: Comprised of investments in
fixed income securities held in pooled investment vehicles. The
valuations of fixed income commingled trusts are based on the
respective net asset values which are determined by the fund
daily at market close. The net asset values are calculated based
on the valuation of the underlying assets which are determined
using observable inputs. The net asset values are not publicly
reported, and funds are valued at the net asset value practical
expedient.
Partnership units: Valued based on the year-end net asset
values of the underlying partnerships. The net asset values of the
partnerships are based on the fair values of the underlying
investments of the partnerships. Quoted market prices are used
to value the underlying investments of the partnerships, where
the partnerships consist of the investment pools which invest
primarily in common stocks. Partnership units include
partnerships, private equity investments, and real asset
investments. Partnerships primarily include long/short equity
and absolute return strategies. These investments may be
redeemed monthly with notice periods ranging from 45 to 95
days. At April 30, 2021, there are no funds in the process of
liquidation. Private equity investments consist of common stock
and debt instruments of private companies. For private equity
funds, the sum of the unfunded commitments at April 30, 2021
is $171 million, and the estimated liquidation period of these
funds is expected to be one to 15 years. Real asset investments
consist of commodities, derivatives, Real Estate Investment
Trusts, and illiquid real estate holdings. These investments have
redemption and liquidation periods ranging from 30 days to 10
years. At April 30, 2021, there are no real estate investments in
the process of liquidation. Valuation procedures are utilized to
arrive at fair value if a quoted market price is not available for a
partnership investment.
Registered investment companies: Valued at net asset values
which are not publicly reported. The net asset values are
calculated based on the valuation of the underlying assets. The
underlying assets are valued at the quoted market prices of
shares held by the plan at year-end in the active market on which
the individual securities are traded.
Insurance contracts: Comprised of investments in collective
(group) insurance contracts, consisting of individual insurance
policies. The policyholder is the employer, and each member is
the owner/beneficiary of their individual insurance policy. These
policies are a part of the insurance company’s general portfolio
and participate in the insurer’s profit-sharing policy on an excess
yield basis.
The methods described above may produce fair values that may
not be indicative of net realizable value or reflective of future fair
values. Furthermore, while the Company believes its valuation
methodologies are appropriate and consistent with other
market participants, the use of different methodologies or
assumptions to determine fair value of certain financial
instruments could result in a different fair value measurement at
the reporting date.
The following tables provide information by level for the
retirement benefit plan assets that are measured at fair value, as
defined by U.S. GAAP. Certain investments for which the fair
value is measured using the net asset value per share (or its
equivalent) practical expedient are not presented within the fair
value hierarchy. The fair value amounts presented for these
investments are intended to permit reconciliation to the total fair
value of plan assets at April 30, 2021 and April 24, 2020.
98
MEDTRONIC PLC 2021 Form 10-K
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Item 8 Financial Statements and Supplementary Data
U.S. Pension Benefits
Fair Value at
April 30, 2021
Fair Value Measurements
Using Inputs Considered as
Investments
Measured at Net
Asset Value(in millions) Level 1 Level 2 Level 3
Short-term investments $ 232 $ 232 $ $ $
Mutual funds 99 99
Equity commingled trusts 1,420 1,420
Fixed income commingled trusts 1,050 1,050
Partnership units 860 860
$ 3,660 $ 331 $ $ 860 $ 2,470
Fair Value at
April 24, 2020
Fair Value Measurements
Using Inputs Considered as
Investments
Measured at Net
Asset Value(in millions) Level 1 Level 2 Level 3
Short-term investments $ 548 $ 548 $ $ $
Equity commingled trusts 1,204 1,204
Fixed income commingled trusts 605 605
Partnership units 625 625
$ 2,982 $ 548 $ $ 625 $ 1,809
The following tables provide a reconciliation of the beginning and ending balances of U.S. pension benefit assets measured at fair value
that used significant unobservable inputs (Level 3):
(in millions)
Partnership
Units
April 26, 2019 $ 629
Total unrealized losses, net (45)
Purchases and sales, net 41
April 24, 2020 625
Total realized gains, net 8
Total unrealized gains, net 89
Purchases and sales, net 139
April 30, 2021 $ 860
Non-U.S. Pension Benefits
Fair Value at
April 30, 2021
Fair Value Measurements
Using Inputs Considered as
Investments
Measured at Net
Asset Value(in millions) Level 1 Level 2 Level 3
Registered investment companies $ 1,850 $ $ $ $ 1,850
Insurance contracts 49 49
$ 1,900 $ $ $ 49 $ 1,850
Fair Value at
April 24, 2020
Fair Value Measurements
Using Inputs Considered as
Investments
Measured at Net
Asset Value
(in millions) Level 1 Level 2 Level 3
Registered investment companies $ 1,361 $ $ $ $ 1,361
Insurance contracts 43 43
$ 1,404 $ $ $ 43 $ 1,361
MEDTRONIC PLC 2021 Form 10-K 99
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Item 8 Financial Statements and Supplementary Data
The following tables provide a reconciliation of the beginning and ending balances of non-U.S. pension benefit assets measured at fair
value that used significant unobservable inputs (Level 3):
(in millions)
Insurance
Contracts
April 26, 2019 $41
Total unrealized gains, net 2
Purchases and sales, net 1
Currency exchange rate changes (1)
April 24, 2020 43
Total unrealized gains, net 2
Purchases and sales, net 1
Currency exchange rate changes 4
April 30, 2021 $49
There were no transfers into or out of Level 3 for both the U.S.
and non-US pension plans during the fiscal years ended April 30,
2021 and April 24, 2020.
Retirement Benefit Plan Funding
It is the Company’s policy to fund retirement costs within the
limits of allowable tax deductions. During fiscal year 2021, the
Company made discretionary contributions of approximately
$95 million to the U.S. pension plan. Internationally, the Company
contributed approximately $149 million for pension benefits
during fiscal year 2021. The Company anticipates that it will make
contributions of $20 million and $78 million to its U.S. pension
benefit plans and non-U.S. pension benefit plans, respectively, in
fiscal year 2022. Based on the guidelines under the U.S.
Employee Retirement Income Security Act of 1974 and the
various guidelines which govern the plans outside the U.S., the
majority of anticipated fiscal year 2022 contributions will be
discretionary. The Company believes that pension assets,
returns on invested pension assets, and Company contributions
will be able to meet its pension and other post-retirement
obligations in the future.
Retiree benefit payments, which reflect expected future service, are anticipated to be paid as follows:
(in millions) Gross Payments
Fiscal Year U.S. Pension Benefits Non-U.S. Pension Benefits
2022 $ 135 $ 62
2023 145 63
2024 157 62
2025 170 67
2026 182 67
2027 – 2031 1,068 395
Total $ 1,856 $ 717
Post-retirement Benefit Plans
The net periodic benefit cost associated with the Company’s
post-retirement benefit plans was income of $6 million,
$15 million, and $17 million in fiscal years 2021, 2020, and 2019,
respectively. The Company’s projected benefit obligation for all
post-retirement benefit plans was $337 million and $339 million
at April 30, 2021 and April 24, 2020, respectively. The Company’s
fair value of plan assets for all post-retirement benefit plans was
$345 million and $296 million at April 30, 2021 and April 24, 2020,
respectively. The post-retirement benefit plan assets at both
April 30, 2021 and April 24, 2020 primarily comprised of equity
and fixed commingled trusts, consistent with the U.S. retirement
benefit plan assets outlined in the fair value leveling tables above.
Defined Contribution Savings Plans
The Company has defined contribution savings plans that cover
substantially all U.S. employees and certain non-U.S. employees.
The general purpose of these plans is to provide additional
financial security during retirement by providing employees with
an incentive to make regular savings. Company contributions to
the plans are based on employee contributions and Company
performance. Expense recognized under these plans was
$495 million, $376 million, and $415 million in fiscal years 2021,
2020, and 2019, respectively.
100
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Item 8 Financial Statements and Supplementary Data
Effective May 1, 2005, the Company froze participation in the
original defined benefit pension plan in the U.S. and implemented
two new plans: an additional defined benefit pension plan, the
Personal Pension Account (PPA), and a new defined contribution
plan, the Personal Investment Account (PIA). Employees in the
U.S. hired on or after May 1, 2005 but before January 1, 2016 had
the option to participate in either the PPA or the PIA. Participants
in the PPA receive an annual allocation of their salary and bonus
on which they will receive an annual guaranteed rate of return,
which is based on the ten-year Treasury bond rate. Participants
in the PIA also receive an annual allocation of their salary and
bonus; however, they are allowed to determine how to invest
their funds among identified fund alternatives. The cost
associated with the PPA is included in U.S. Pension Benefits in
the tables presented earlier. The defined contribution cost
associated with the PIA was approximately $50 million,
$52 million, and $54 million in fiscal years 2021, 2020, and 2019,
respectively.
Effective January 1, 2016, the Company froze participation in the
existing defined benefit (PPA) and contribution (PIA) pension
plans in the U.S. and implemented a new form of benefit under
the existing defined contribution plan for legacy Covidien
employees and employees in the U.S. hired on or after January 1,
2016 or rehired after July 1, 2020. Participants in the Medtronic
Core Contribution (MCC) also receive an annual allocation of
their salary and bonus and are allowed to determine how to
invest their funds among identified fund alternatives. The
defined contribution cost associated with the MCC was
approximately $73 million, $66 million, and $58 million and in
fiscal years 2021, 2020, and 2019, respectively.
16. Leases
The Company leases office, manufacturing, and research
facilities and warehouses, as well as transportation, data
processing, and other equipment. The Company determines
whether a contract is a lease or contains a lease at inception
date. Upon commencement, the Company recognizes a
right-of-use asset and lease liability. Right-of-use assets
represent the Company’s right to use the underlying asset for
the lease term. Lease liabilities are the Company’s obligation to
make the lease payments arising from a lease. As the Company’s
leases typically do not provide an implicit rate, the Company’s
lease liabilities are measured on a discounted basis using the
Company’s incremental borrowing rate. Lease terms used in the
recognition of right-of-use assets and lease liabilities include
only options to extend the lease that are reasonably certain to be
exercised. Additionally, lease terms underlying the right-of-use
assets and lease liabilities consider terminations that are
reasonably certain to be executed.
The Company’s lease agreements include leases that have both
lease and associated nonlease components. The Company has
elected to account for lease components and the associated
nonlease components as a single lease component. The
consolidated balance sheets do not include recognized assets or
liabilities for leases that, at the commencement date, have a
term of twelve months or less and do not include an option to
purchase the underlying asset that is reasonably certain to be
exercised. The Company recognizes such leases in the
consolidated statements of income on a straight-line basis over
the lease term. Additionally, the Company recognizes variable
lease payments not included in its lease liabilities in the period in
which the obligation for those payments is incurred. Variable
lease payments for fiscal year 2021 and 2020 were not material.
The Company’s lease agreements include leases accounted for
as operating leases and those accounted for as finance leases.
The right-of-use assets, lease liabilities, lease costs, cash flows,
and lease maturities associated with the Company’s finance
leases were not material to the consolidated financial
statements at April 30, 2021 or April 24, 2020 or for fiscal year
2021 or 2020. Finance lease right-of-use assets are included in
property, plant, and equipment, net, and finance lease liabilities
are included in current debt obligations and long-term debt on
the consolidated balance sheets.
The following table summarizes the balance sheet classification of the Company’s operating leases and amounts of the right-of-use
assets and lease liabilities at April 30, 2021 and April 24, 2020:
(in millions)
Balance Sheet
Classification April 30, 2021 April 24, 2020
Right-of-use assets Other assets $ 998 $ 927
Current liability Other accrued expenses 186 171
Non-current liability Other liabilities 829 774
The following table summarizes the weighted-average remaining lease term and weighted-average discount rate for the Company’s
operating leases at April 30, 2021 and April 24, 2020:
April 30, 2021 April 24, 2020
Weighted-average remaining lease term 7.5 years 7.2 years
Weighted-average discount rate 2.3% 3.0%
MEDTRONIC PLC 2021 Form 10-K 101
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Item 8 Financial Statements and Supplementary Data
The following table summarizes the components of total operating lease cost for fiscal year 2021 and 2020:
(in millions) Fiscal Year 2021 Fiscal Year 2020
Operating lease cost $ 216 $ 223
Short-term lease cost 35 46
Total operating lease cost $ 251 $ 269
Rent expense for all operating leases was $305 million in fiscal year 2019.
The following table summarizes the cash paid for amounts included in the measurement of operating lease liabilities and right-of-use
assets obtained in exchange for operating lease liabilities for fiscal year 2021 and 2020:
(in millions) Fiscal Year 2021 Fiscal Year 2020
Cash paid for amounts included in the measurement of operating lease liabilities $ 216 $ 221
Right-of-use assets obtained in exchange for operating lease liabilities 230 174
The following table summarizes the maturities of the Company’s operating leases at April 30, 2021:
(in millions)
Fiscal Year
Operating
Leases
2022 $ 223
2023 166
2024 147
2025 119
2026 97
Thereafter 338
Total expected lease payments 1,090
Less: Imputed interest (75)
Total lease liability $ 1,015
The Company makes certain products available to customers
under lease arrangements, including arrangements whereby
equipment is placed with customers who then purchase
consumable products to accompany the use of the equipment.
Income arising from arrangements where the Company is the
lessor is recognized within net sales in the consolidated
statements of income and the Company’s net investments in
sales-type leases are included in other current assets and other
assets in the consolidated balance sheets. Lessor income and
the related assets and lease maturities were not material to the
consolidated financial statements at or for the fiscal year ended
April 30, 2021 and April 30, 2021.
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Item 8 Financial Statements and Supplementary Data
17. Accumulated Other Comprehensive Loss
The following table provides changes in AOCI, net of tax and by component:
(in millions)
Unrealized
(Loss) Gain on
Investment
Securities
Cumulative
Translation
Adjustments
Net
Investment
Hedges
Net Change
in Retirement
Obligations
Unrealized
(Loss) Gain
on Cash Flow
Hedges
Total
Accumulated
Other
Comprehensive
(Loss) Income
April 27, 2018 $ (194) $ (11) $ (257) $ (1,117) $ (207) $ (1,786)
Other comprehensive income
(loss) before reclassifications 67 (1,372) 88 (266) 457 (1,026)
Reclassifications 35 75 (56) 54
Other comprehensive income (loss) 102 (1,372) 88 (191) 401 (972)
Cumulative effect of change in
accounting principle
(1)
47 47
April 26, 2019 (45) (1,383) (169) (1,308) 194 (2,711)
Other comprehensive income
(loss) before reclassifications 43 (827) 405 (596) 309 (666)
Reclassifications 2 52 (237) (183)
Other comprehensive income (loss) 45 (827) 405 (544) 72 (849)
April 24, 2020 (2,210) 236 (1,852) 266 (3,560)
Other comprehensive income
(loss) before reclassifications 92 1,691 (1,694) 432 (541) (20)
Reclassifications 73 22 95
Other comprehensive income (loss) 92 1,691 (1,694) 505 (519) 75
April 30, 2021 $ 92 $ (519) $ (1,458) $ (1,347) $ (253) $ (3,485)
(1) The cumulative effect of change in accounting principle in fiscal year 2019 resulted from the adoption of accounting guidance that requires equity
investments (except those accounted for under the equity method of accounting or those that result in consolidation of the investee) to be
measured at fair value with changes in fair value recognized in net income.
The income tax on gains and losses on investment securities in
other comprehensive income before reclassifications during
fiscal years 2021, 2020, and 2019 was an expense of $31 million,
a benefit of $13 million and a benefit of $5 million, respectively.
Realized gains and losses on investment securities reclassified
from AOCI were reduced by income taxes of $2 million for fiscal
year 2021 and $3 million for fiscal years 2020 and 2019. When
realized, gains and losses on investment securities reclassified
from AOCI are recognized within other non-operating income,
net. Refer to Note 5 for additional information.
During fiscal years 2021, 2020, and 2019, the income tax on
cumulative translation adjustment was an expense of $7 million,
a benefit of $9 million, and a benefit of $7 million, respectively.
During fiscal years 2021, 2020, and 2019, there were no tax
impacts on net investment hedges. Refer to Note 7 for
additional information.
The net change in retirement obligations in other
comprehensive income includes amortization of net actuarial
losses included in net periodic benefit cost. The income tax on
the net change in retirement obligations in other comprehensive
income before reclassifications during fiscal years 2021, 2020,
and 2019 resulted in an expense of $115 million and a benefit of
$159 million, and $63 million, respectively. During fiscal years
2021, 2020, and 2019, the gains and losses on defined benefit
and pension items reclassified from AOCI were reduced by
income taxes of $16 million, $12 million, and $19 million,
respectively. When realized, net gains and losses on defined
benefit and pension items reclassified from AOCI are recognized
within other non-operating income, net. Refer to Note 15 for
additional information.
The income tax on unrealized gains and losses on cash flow
hedges in other comprehensive income before reclassifications
during fiscal years 2021, 2020, and 2019 was a benefit of
$87 million and an expense of $88 million and $158 million,
respectively. Amounts reclassified from AOCI related to cash
flow hedges included income taxes of $14 million, $80 million,
and $24 million for fiscal years 2021, 2020, and 2019,
respectively. When realized, gains and losses on currency
exchange rate contracts reclassified from AOCI are recognized
within other operating expense, net and gains and losses on
forward starting interest rate derivatives reclassified from AOCI
are recognized within interest expense. Refer to Note 7 for
additional information.
MEDTRONIC PLC 2021 Form 10-K 103
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Item 8 Financial Statements and Supplementary Data
18. Commitments and Contingencies
Legal Matters
The Company and its affiliates are involved in a number of legal
actions involving product liability, intellectual property and
commercial disputes, shareholder related matters,
environmental proceedings, tax disputes, and governmental
proceedings and investigations, including those described below.
With respect to governmental proceedings and investigations,
like other companies in our industry, the Company is subject to
extensive regulation by national, state, and local governmental
agencies in the United States and in other jurisdictions in which
the Company and its affiliates operate. As a result, interaction
with governmental agencies is ongoing. The Company’s
standard practice is to cooperate with regulators and
investigators in responding to inquiries. The outcomes of legal
actions are not within the Company’s complete control and may
not be known for prolonged periods of time. In some actions, the
enforcement agencies or private claimants seek damages, as
well as other civil or criminal remedies (including injunctions
barring the sale of products that are the subject of the
proceeding), that could require significant expenditures, result in
lost revenues, or limit the Company’s ability to conduct business
in the applicable jurisdictions.
The Company records a liability in the consolidated financial
statements on an undiscounted basis for loss contingencies
related to legal actions when a loss is known or considered
probable and the amount may 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 other,
the minimum amount of the range is accrued. If a loss is
reasonably possible but not known or probable, and may 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. Estimates of probable losses
resulting from litigation and governmental proceedings involving
the Company are inherently difficult to predict, particularly when
the matters are in early procedural stages with incomplete
scientific facts or legal discovery, involve unsubstantiated or
indeterminate claims for damages, potentially involve penalties,
fines or punitive damages, or could result in a change in business
practice. The Company classifies litigation charges and gains
related to significant legal matters as certain litigation charges.
During fiscal years 2021, 2020, and 2019, the Company
recognized $118 million, $313 million, and $166 million,
respectively, of certain litigation charges. At April 30, 2021 and
April 24, 2020, accrued litigation was approximately $0.4 billion
and $0.5 billion, respectively. The ultimate cost to the Company
with respect to accrued litigation could be materially different
than the amount of the current estimates and accruals and could
have a material adverse impact on the Company’s consolidated
earnings, financial position, and/or cash flows. The Company
includes accrued litigation in other accrued expenses and other
liabilities on the consolidated balance sheets. While it is not
possible to predict the outcome for most of the legal matters
discussed below, the Company believes it is possible that the
costs associated with these matters could have a material
adverse impact on the Company’s consolidated earnings,
financial position, and/or cash flows.
Product Liability Matters
Pelvic Mesh Litigation
The Company is currently involved in litigation in various state
and federal courts against manufacturers of pelvic mesh
products alleging personal injuries resulting from the
implantation of those products. Two subsidiaries of Covidien
supplied pelvic mesh products to one of the manufacturers, C.R.
Bard (Bard), named in the litigation. The litigation includes a
federal multi-district litigation in the U.S. District Court for the
Northern District of West Virginia and cases in various state
courts and jurisdictions outside the U.S. Generally, complaints
allege design and manufacturing claims, failure to warn, breach of
warranty, fraud, violations of state consumer protection laws and
loss of consortium claims. In fiscal year 2016, Bard paid the
Company $121 million towards the settlement of 11,000 of
these claims. In May 2017, the agreement with Bard was
amended to extend the terms to apply to up to an additional
5,000 claims. That agreement does not resolve the dispute
between the Company and Bard with respect to claims that do
not settle, if any. As part of the agreement, the Company and
Bard agreed to dismiss without prejudice their pending litigation
with respect to Bard’s obligation to defend and indemnify the
Company. The Company estimates law firms representing
approximately 16,200 claimants have asserted or may assert
claims involving products manufactured by Covidien’s
subsidiaries. As of June 2, 2021, the Company had reached
agreements to settle approximately 15,900 of these claims. The
Company’s accrued expenses for this matter are included within
accrued litigation as discussed above.
Hernia Mesh Litigation
Starting in fiscal year 2020, plaintiffs filed lawsuits against certain
subsidiaries of the Company in U.S. state and federal courts
alleging personal injury from hernia mesh products sold by those
subsidiaries. The majority of the pending cases are in
Massachusetts state court, where they have been consolidated
before a single judge. Certain plaintiffs’ law firms have advised
the Company that they may file a large volume of additional
cases in the future. The pending lawsuits relate almost entirely to
hernia mesh products that have not been subject to recalls,
withdrawals or other adverse regulatory action. The Company
has not recorded an expense related to damages in connection
with these matters because any potential loss is not currently
probable or reasonably estimable under U.S. GAAP. Additionally,
the Company is unable to reasonably estimate the range of loss,
if any, that may result from these matters.
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Item 8 Financial Statements and Supplementary Data
Patent Litigation
Ethicon
On December 14, 2011, Ethicon filed an action against Covidien
in the U.S. District Court for the Southern District of Ohio,
alleging patent infringement and seeking monetary damages and
injunctive relief. On January 22, 2014, the district court entered
summary judgment in Covidien’s favor, and the majority of this
ruling was affirmed by the Federal Circuit on August 7, 2015.
Following appeal, the case was remanded back to the District
Court with respect to one patent. On January 21, 2016, Covidien
filed a second action in the U.S. District Court for the Southern
District of Ohio, seeking a declaration of non-infringement with
respect to a second set of patents held by Ethicon. The court
consolidated this second action with the remaining patent issues
from the first action. Following consolidation of the cases,
Ethicon dismissed six of the asserted patents, leaving a single
asserted patent. In March 2021, the consolidated action was
dismissed with prejudice, pursuant to a settlement agreement.
Sasso
The Company is involved in litigation in Indiana relating to certain
patent and royalty disputes with Dr. Sasso under agreements
originally entered into in 1999 and 2001. On November 28, 2018,
a jury in Indiana state court returned a verdict against the
Company for approximately $112 million. On June 15, 2021,
pursuant to an order from the state court, the Company paid the
judgment plus accrued interest to Dr. Sasso, subject to
repayment if the Company’s ongoing appeal is successful.
Shareholder Related Matters
Covidien Acquisition
On July 2, 2014, Lewis Merenstein filed a putative shareholder
class action in Hennepin County, Minnesota, District Court
seeking to enjoin the then-potential acquisition of Covidien. The
lawsuit named Medtronic, Inc., Covidien, and each member of
the Medtronic, Inc. Board of Directors at the time as defendants,
and alleged that the directors breached their fiduciary duties to
shareholders with regard to the then-potential acquisition. On
August 21, 2014, Kenneth Steiner filed a putative shareholder
class action in Hennepin County, Minnesota, District Court, also
seeking an injunction to prevent the potential Covidien
acquisition. In September 2014, the Merenstein and Steiner
matters were consolidated. In April 2021, the parties reach an
agreement to resolve this matter, bringing it to a conclusion.
Environmental Proceedings
The Company is involved in various stages of investigation and
cleanup related to environmental remediation matters at a
number of sites. These projects relate to a variety of activities,
including removal of solvents, metals and other hazardous
substances from soil and groundwater. The ultimate cost of site
cleanup and timing of future cash flows is difficult to predict given
uncertainties regarding the extent of the required cleanup, the
interpretation of applicable laws and regulations, and alternative
cleanup methods.
The Company is a successor to a company which owned and
operated a chemical manufacturing facility in Orrington, Maine
from 1967 until 1982, and is responsible for the costs of
completing an environmental site investigation as required by
the Maine Department of Environmental Protection (MDEP).
MDEP served a compliance order on Mallinckrodt LLC and U.S.
Surgical Corporation, subsidiaries of Covidien, in December
2008, which included a directive to remove a significant volume
of soils at the site. After a hearing on the compliance order
before the Maine Board of Environmental Protection (Maine
Board) to challenge the terms of the compliance order, the
Maine Board modified the MDEP order and issued a final order
requiring removal of two landfills, capping of the remaining three
landfills, installation of a groundwater extraction system and
long-term monitoring of the site and the three remaining
landfills.
The Company has proceeded with implementation of the
investigation and remediation at the site in accordance with the
MDEP order as modified by the Maine Board order.
Since the early 2000s, the Company or its predecessors have
also been involved in a lawsuit filed in the U.S. District Court for
the District of Maine by the Natural Resources Defense Council
and the Maine People’s Alliance. Plaintiffs sought an injunction
requiring the Company’s predecessor to conduct extensive
studies of mercury contamination of the Penobscot River and
Bay and options for remediating such contamination, and to
perform appropriate remedial activities, if necessary.
Following a trial in March 2002, the Court held that conditions in
the Penobscot River and Bay may pose an imminent and
substantial endangerment and that the Company’s predecessor
was liable for the cost of performing a study of the River and Bay.
Following a second trial in June 2014, the Court ordered that
further engineering study and engineering design work was
needed to determine the nature and extent of remediation in the
Penobscot River and Bay. The Court also appointed an
engineering firm to conduct such studies and issue a report on
potential remediation alternatives. In connection with these
proceedings, reports have been produced including a variety of
cost estimates for a variety of potential remedial options. In
March 2021, the parties notified the Court that they had agreed
on a settlement in principle of all issues in this matter. Finalization
of the proposed settlement remains subject to a fairness hearing
and Court approval.
The Company’s accrued expenses for environmental
proceedings are included within accrued litigation as discussed
above.
Income Taxes
In March 2009, the IRS issued its audit report on Medtronic, Inc.
for fiscal years 2005 and 2006. Medtronic, Inc. reached
agreement with the IRS on some, but not all matters related to
these fiscal years. The remaining unresolved issue for fiscal years
2005 and 2006 relates to the allocation of income between
Medtronic, Inc. and its wholly-owned subsidiary operating in
Puerto Rico, which is one of the Company’s key manufacturing
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Item 8 Financial Statements and Supplementary Data
sites. The U.S. Tax Court reviewed this dispute, and on June 9,
2016, issued its opinion with respect to the allocation of income
between the parties for fiscal years 2005 and 2006. The U.S. Tax
Court generally rejected the IRS’s position, but also made certain
modifications to the Medtronic, Inc. tax returns as filed. On
April 21, 2017, the IRS filed their Notice of Appeal to the U.S.
Court of Appeals for the 8th Circuit regarding the Tax Court
Opinion. Oral argument for the Appeal occurred on March 14,
2018. The 8th Circuit Court of Appeals issued their opinion on
August 16, 2018 and remanded the case back to the U.S. Tax
Court for additional factual findings. The U.S. Tax Court trial was
held in June 2021.
In October 2011, the IRS issued its audit report on Medtronic,
Inc. for fiscal years 2007 and 2008. Medtronic, Inc. reached
agreement with the IRS on some, but not all matters related to
these fiscal years. The remaining unresolved issue for fiscal years
2007 and 2008 relates to the allocation of income between
Medtronic, Inc. and its wholly-owned subsidiary operating in
Puerto Rico for the businesses that are the subject of the U.S.
Tax Court Case for fiscal years 2005 and 2006.
In April 2014, the IRS issued its audit report on Medtronic, Inc. for
fiscal years 2009, 2010, and 2011. Medtronic, Inc. reached
agreement with the IRS on some but not all matters related to
these fiscal years. The remaining unresolved issue for fiscal years
2009, 2010, and 2011 relates to the allocation of income
between Medtronic, Inc. and its wholly-owned subsidiary
operating in Puerto Rico for the businesses that are the subject
of the U.S. Tax Court Case for fiscal years 2005 and 2006.
In May 2017, the IRS issued its audit report on Medtronic, Inc. for
fiscal years 2012, 2013, and 2014. Medtronic, Inc. reached
agreement with the IRS on some but not all matters related to
these fiscal years. During January 2021, Medtronic, Inc. and the
IRS resolved the outstanding matters related to the allocation of
income between Medtronic, Inc. and its wholly-owned subsidiary
operating in Puerto Rico for the businesses that are not the
subject of the U.S. Tax Court Case and the utilization of certain
net operating losses. The remaining unresolved issue for fiscal
years 2012, 2013 and 2014 relates to the allocation of income
between Medtronic, Inc. and its wholly-owned subsidiary
operating in Puerto Rico for the businesses that are the subject
of the U.S. Tax Court Case for fiscal years 2005 and 2006.
In November 2020, the IRS issued its audit report on Medtronic,
Inc. for fiscal years 2015 and 2016. Medtronic, Inc. reached
agreement with the IRS on some but not all matters related to
these fiscal years. The significant issue that remains unresolved
relates to the allocation of income between Medtronic, Inc. and
its wholly owned subsidiary operating in Puerto Rico for the
businesses that are the subject of the U.S. Tax Court Case for
fiscal years 2005 and 2006.
Medtronic, Inc.’s fiscal years 2017, 2018, and 2019 U.S. federal
income tax returns are currently being audited by the IRS.
In January 2021, the IRS issued its audit report for Covidien’s
fiscal year 2015 U.S. federal income tax returns. Covidien
reached agreement with the IRS on all matters related to fiscal
year 2015. The statute of limitations for Covidien’s 2016 and
2017 U.S. federal income tax returns lapsed during the third
quarter of fiscal year 2020 and 2021, respectively.
While it is not possible to predict the outcome for most of the
income tax matters discussed above, the Company believes it is
possible that charges associated with these matters could have
a material adverse impact on the Company’s consolidated
earnings, financial position, and/or cash flows.
See Note 13 for additional discussion of income taxes.
Guarantees
As part of the Company’s sale of the Patient Care, Deep Vein
Thrombosis, and Nutritional Insufficiency businesses to Cardinal
on July 29, 2017, the Company has indemnified Cardinal for
certain contingent tax liabilities related to the divested
businesses that existed prior to the date of divestiture. The
actual amounts that the Company may be required to ultimately
accrue or pay could vary depending upon the outcome of the
unresolved tax matters.
In the normal course of business, the Company and/or its
affiliates periodically enter into agreements that require one or
more of the Company and/or its affiliates to indemnify
customers or suppliers for specific risks, such as claims for injury
or property damage arising as a result of the Company or its
affiliates’ products, the negligence of the Company’s personnel,
or claims alleging that the Company’s products infringe on third-
party patents or other intellectual property. The Company also
offers warranties on various products. The Company’s maximum
exposure under these guarantees is unable to be estimated.
Historically, the Company has not experienced significant losses
on these types of guarantees.
The Company believes the ultimate resolution of the above
guarantees is not expected to have a material effect on the
Company’s consolidated earnings, financial position, and/or cash
flows.
19. Segment and Geographic Information
Effective February 1, 2021, the Company implemented a new
operating model, moving from a Group structure to a Portfolio
structure: Cardiovascular Portfolio (formerly Cardiac and
Vascular Group), Neuroscience Portfolio (formerly Restorative
Therapies Group), and Medical Surgical Portfolio (formerly
Minimally Invasive Therapies Group). The Diabetes Operating
Unit (formerly Diabetes Group) remains a separate operating and
reportable segment in the new structure. There were no
changes to the reportable segments during the fiscal year ended
April 30, 2021, such that the four principal operating and
reportable segments are as follows: Cardiovascular Portfolio,
Neuroscience Portfolio, Medical Surgical Portfolio, and Diabetes
Operating Unit.
The Company’s management has chosen to organize the entity
based upon therapy solutions provided by each segment. The
four principal segments are strategic businesses that are
managed separately, as each one develops and manufactures
products and provides services oriented toward targeted
therapy solutions.
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MEDTRONIC PLC 2021 Form 10-K
PART II
Item 8 Financial Statements and Supplementary Data
The primary products and services from which the
Cardiovascular Portfolio segment derives its revenues include
products for the diagnosis, treatment, and management of
cardiac rhythm disorders and cardiovascular disease, as well as
services to diagnose, treat, and manage heart and vascular-
related disorders and diseases.
The primary products and services from which the Medical
Surgical Portfolio segment derives its revenues include those
focused on diseases of the respiratory system, gastrointestinal
tract, renal system, lungs, pelvic region, kidneys, obesity, and
other preventable complications.
The primary products and services from which the Neuroscience
Portfolio segment derives its revenues include those focused on
neurostimulation therapies and drug delivery systems for the
treatment of chronic pain, as well as various areas of the spine
and brain, along with pelvic health and conditions of the ear,
nose, and throat.
The primary products from which the Diabetes Operating Unit
segment derives its revenues include those focused on diabetes
management, including insulin pumps, continuous glucose
monitoring systems, smart insulin pens, and insulin pump
consumables.
Segment disclosures are on a performance basis, consistent
with internal management reporting. Net sales of the Company’s
segments include end-customer revenues from the sale of
products the segment develops, manufactures, and distributes.
There are certain corporate and centralized expenses that are
not allocated to the segments. The Company’s management
evaluates the performance of the segments and allocates
resources based on net sales and segment operating profit.
Segment operating profit represents income before income
taxes, excluding interest expense, amortization of intangible
assets, centralized distribution costs, non-operating income or
expense items, certain corporate charges, and other items not
allocated to the segments.
The accounting policies of the segments are the same as those
described in Note 1. Certain depreciable assets may be recorded
by one segment, while the depreciation expense is allocated to
another segment. The allocation of depreciation expense is
based on the proportion of the assets used by each segment.
Segment Operating Profit
Fiscal Year
(in millions) 2021 2020 2019
Cardiovascular $ 3,850 $ 3,719 $ 4,532
Medical Surgical 3,021 3,044 3,262
Neuroscience 3,162 2,915 3,319
Diabetes 598 546 739
Segment operating profit 10,632 10,224 11,852
Interest expense (925) (1,092) (1,444)
Other non-operating income, net 336 356 373
Amortization of intangible assets (1,783) (1,756) (1,764)
Corporate (1,577) (1,239) (1,291)
Centralized distribution costs (1,877) (1,420) (1,689)
Restructuring and associated costs (617) (441) (407)
Acquisition-related items 15 (66) (88)
Certain litigation charges (118) (313) (166)
Impairment charges (76)
IPR&D charges (31) (25) (58)
Exit of businesses (52) (149)
Debt tender premium and other charges 7 28
Medical device regulations (83) (48)
Contribution to Medtronic Foundation (80)
Income before income taxes $ 3,895 $ 4,055 $ 5,197
MEDTRONIC PLC 2021 Form 10-K 107
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Item 8 Financial Statements and Supplementary Data
Total Assets and Depreciation Expense
Total Assets Depreciation Expense
(in millions) April 30, 2021 April 24, 2020 2021 2020 2019
Cardiovascular $ 15,027 $ 14,844 $ 212 $ 210 $ 194
Medical Surgical 39,319 39,666 195 194 206
Neuroscience 17,151 16,850 236 233 217
Diabetes 3,671 3,165 53 38 34
Segments 75,168 74,525 696 675 651
Corporate 17,915 16,164 223 232 244
Total $ 93,083 $ 90,689 $ 919 $ 907 $ 895
Geographic Information
Net sales are attributed to the country based on the location of the customer taking possession of the products or in which the services
are rendered. Geographic property, plant, and equipment are attributed to the country based on the physical location of the assets.
The following table presents net sales for fiscal years 2021, 2020, and 2019, and property, plant, and equipment, net at April 30, 2021 and
April 24, 2020 for the Company’s country of domicile, countries with significant concentrations, and all other countries:
Net sales Property, plant, and equipment, net
(in millions) 2021 2020 2019 April 30, 2021 April 24, 2020
Ireland $ 100 $ 85 $ 91 $ 170 $ 164
United States 15,526 14,919 16,194 3,688 3,459
Rest of world 14,491 13,909 14,272 1,363 1,205
Total other countries, excluding Ireland 30,017 28,828 30,466 5,051 4,664
Total $ 30,117 $ 28,913 $ 30,557 $ 5,221 $ 4,828
No single customer represented over 10 percent of the Company’s consolidated net sales in fiscal years 2021, 2020, or 2019.
20. Subsequent Events
On June 3, 2021, the Company announced the decision to stop
the distribution and sale of the Medtronic HVAD System in light
of a growing body of observational clinical comparisons
indicating a lower frequency of neurological adverse events and
mortality with another circulatory support device available to
patients compared to the HVAD system. Fiscal year 2021 HVAD
system and associated accessory revenue was $141 million and
is included in our Cardiovascular segment. The Company
expects to record a non-cash pre-tax impairment of long-lived
assets of $400 million to $500 million in the quarter ending
July 30, 2021 primarily related to intangible assets. The Company
remains committed to serving the needs of the 4,000 patients
currently implanted with this device.
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PART II
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure
Not applicable.
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive
Officer and Chief Financial Officer, has evaluated the
effectiveness of the design and operation of our disclosure
controls and procedures (as defined in Rule 13a-15(e) under the
Securities Exchange Act of 1934, as amended (the Exchange
Act)) and changes in the Company’s internal control over
financial reporting (as defined in Rule 13a-15(f) under the
Exchange Act) as of the end of the period covered by this report.
Based upon that evaluation, the Chief Executive Officer and
Chief Financial Officer have concluded that, as of the end of the
period covered by this annual report, our disclosure controls and
procedures (as defined in Rule 13a-15(e) of the Exchange Act)
are effective.
Management’s Annual Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining
adequate internal control over financial reporting for the
Company (as defined in Exchange Act Rule 13a-15(f)).
Management conducted an evaluation of the effectiveness of
internal control over financial reporting based on the framework
in Internal Control Integrated Framework (2013) issued by the
Committee of Sponsoring Organizations of the Treadway
Commission (COSO). Based on this evaluation, management
concluded that the Company’s internal control over financial
reporting was effective at April 30, 2021. The effectiveness of
the Company’s internal control over financial reporting as of
April 30, 2021 has been audited by PricewaterhouseCoopers
LLP, an independent registered public accounting firm, as stated
in its report which is included in “Item 8. Financial Statements and
Supplementary Data” in this Annual Report on Form 10-K.
Changes in Internal Control Over Financial Reporting
During the quarter ended April 30, 2021, there were no changes
in our internal control over financial reporting (as defined in Rules
13a-15(f) under the Exchange Act) that have materially affected,
or are reasonably likely to materially affect, the Company’s
internal control over financial reporting. The Company has not
experienced any material impacts to its internal controls over
financial reporting despite the fact that most of its employees
are working remotely due to the COVID-19 pandemic.
Item 9B. Other Information
Medtronic has engaged in certain activities that it is required to
disclose pursuant to Section 13(r)(1)(D)(ii) of the Securities
Exchange Act of 1934, as amended. The activities described
herein are expressly authorized by the U.S. Government under
applicable economic sanctions regulations.
Specifically, Medtronic’s affiliate in Russia, Medtronic Russia LLC
(“Medtronic Russia”), is required under Russian law to complete
certain notification and filing requirements to Russia’s Federal
Security Service (“FSB”) regarding certain Medtronic medical
devices that make use of encryption functionality that are
imported into Russia. While the FSB has been included on the
Specially Designated Nationals (“SDN”) List administered by the
Office of Foreign Assets Control (“OFAC”), these activities are
and remain authorized. In particular, Cyber General License No.
1B (“Cyber GL 1B”), issued by OFAC, authorizes all transactions
ordinarily incident to obtaining such permits from the FSB,
provided that certain conditions are met.
Historically, Medtronic has not been required to disclose these
lawful dealings with the FSB. However, on March 2, 2021, OFAC
designated the FSB pursuant to an additional sanctions
authority. While OFAC amended the applicable general license to
confirm that all previously authorized dealings with the FSB
remain authorized (notwithstanding the additional designation),
the designation of the FSB with a [NPWMD] tag pursuant to
Executive Order 13382 means that Medtronic is required under
Section 13(r)(1)(D)(ii) of the Securities Exchange Act to disclose
MEDTRONIC PLC 2021 Form 10-K 109
PART II
Item 9B Other Information
certain information as a result of this additional designation, as
Section 13(r)(1)(D)(ii) does not contain an exception from its
reporting requirements for activities that are authorized by the
U.S. Government.
Since March 2, 2021, in the normal course of business and
consistent with the authorization of Cyber GL 1B, Medtronic
Russia filed five notifications with the FSB, as required under local
Russian law for the import of medical devices that make use of
encryption functionality. These activities did not directly result in
any revenues or profits for Medtronic. Medtronic intends to
continue engaging in activities for which it is authorized by Cyber
GL 1B (or any successor GL), to the extent necessary to comply
with local law requirements in Russia.
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MEDTRONIC PLC 2021 Form 10-K
PART III
Part III of this Annual Report on Form 10-K incorporates information by reference from the Company’s 2021 definitive proxy statement,
which will be filed no later than 120 days after April 30, 2021.
Item 10. Directors, Executive Officers, and Corporate Governance
The sections entitled “Proposal 1 — Election of Directors —
Directors and Nominees,” “Corporate Governance —
Committees of the Board and Meetings,” and “Share Ownership
Information — Delinquent Section 16(a) Report” in the
Company’s Proxy Statement for our 2021 Annual General
Meeting of Shareholders, which will be filed no later than 120
days after April 30, 2021, are incorporated herein by reference.
Set forth below are the names and ages of our Section 16(b)
executive officers of Medtronic, as well as information regarding
their positions with Medtronic, their periods of service in these
capacities, and their business experiences. There are no family
relationships among any of the officers named, nor is there any
arrangement or understanding pursuant to which any person
was selected as an officer.
The following table shows the name, age, and position as of April 30, 2021 of each of our executive officers:
Name Age Position with the Company
Geoffrey S. Martha 51 Chairman and Chief Executive Officer
Richard Kuntz, M.D. 64 Senior Vice President and Chief Medical and Scientific Officer
Bradley E. Lerman 64 Senior Vice President, General Counsel and Corporate Secretary of the Company
Karen L. Parkhill 55 Executive Vice President and Chief Financial Officer
Carol A. Surface 55 Senior Vice President and Chief Human Resources Officer
Robert ten Hoedt 60 Executive Vice President and President, EMEA Region
Robert J. White 58 Executive Vice President and President, Medical Surgical Portfolio
John Liddicoat, M.D. 57 Executive Vice President and President, Americas Region
Sean Salmon 56 Executive Vice President and President, Diabetes Operating Unit, President,
Cardiovascular Portfolio
Brett Wall 56 Executive Vice President and President, Neuroscience Portfolio
Geoffrey S. Martha, age 51, is Chairman of the Board of
Directors and Chief Executive Officer of Medtronic. Geoff
assumed the role of CEO on April 27, 2020 and became
Chairman of the Board on December 11, 2020. Prior to his role as
Chairman and CEO, he served as President of Medtronic from
November 2019 through April 2020 and joined the Board of
Directors in November 2019. Previously, Mr. Martha served as
Executive Vice President and President, Restorative Therapies
Group, a role he held since August 2015. Mr. Martha previously
served as Senior Vice President of Strategy and Business
Development of the Company beginning in January 2015 and of
Medtronic, Inc. beginning in August 2011. Prior to that, he served
as Managing Director of Business Development at GE
Healthcare from April 2007 to July 2011; General Manager for GE
Capital Technology Finance Services from November 2003 to
March 2007; Senior Vice President, Business Development for
GE Capital Vendor Financial Services from February 2002 to
October 2003; General Manager for GE Capital Colonial Pacific
Leasing from February 2001 to January 2002; and Vice
President, Business Development for Potomac Federal, the GE
Capital federal financing investment bank from May 1998 to
January 2001.
Richard Kuntz, M.D., age 64, has been Senior Vice President and
Chief Medical and Scientific Officer of the Company since
January 2015 and of Medtronic, Inc. since August 2009. Prior to
that, he was Senior Vice President and President,
Neuromodulation from October 2005 to August 2009; and prior
to that, he was an interventional cardiologist and Chief of the
Division of Clinical Biometrics at Brigham and Women’s Hospital
and Associate Professor of Medicine and Chief Scientific Officer
of the Harvard Clinical Research Institute.
Bradley E. Lerman, age 64, has been Senior Vice President,
General Counsel and Corporate Secretary of the Company since
January 2015 and of Medtronic, Inc. since May 2014. Prior to
that, he was Executive Vice President, General Counsel and
Corporate Secretary at Federal National Mortgage Association
(Fannie Mae) from October 2012 to May 2014; Senior Vice
President and Chief Litigation Counsel at Pfizer, Inc. from
January 2009 to September 2012; Partner at Winston & Strawn
MEDTRONIC PLC 2021 Form 10-K 111
PART III
Item 11 Executive Compensation
from August 1998 to January 2009; partner at Kirkland & Ellis
from March 1996 to July 1998; Associate Independent Counsel
from October 1994 to March 1996; and Assistant U.S. Attorney
in the Northern District of Illinois from February 1986 to
September 1994. Mr. Lerman is also a current member of the
Board of Directors of McKesson Corporation.
Karen L. Parkhill, age 55, joined the Company as Executive Vice
President and Chief Financial Officer in June 2016. From 2011 to
2016, Ms. Parkhill served as Vice Chairman and Chief Financial
Officer of Comerica Incorporated. Ms. Parkhill was a member of
Comerica’s Management Executive Committee and the
Comerica Bank Board of Directors. Prior to joining Comerica,
Ms. Parkhill worked for J.P. Morgan Chase & Co. in various
capacities from 1992 to 2011, including serving as Chief Financial
Officer of the Commercial Banking business from 2007 to 2011.
Ms. Parkhill is also a current member of the Board of Directors for
American Express.
Carol A. Surface, age 55, has been Senior Vice President and
Chief Human Resources Officer of the Company since January
2015 and of Medtronic, Inc. since September 2013. Prior to that,
she was the Executive Vice President and Chief Human
Resources Officer at Best Buy Co., Inc. from March 2010 to
September 2013, and held a series of HR leadership roles at
PepsiCo Inc., from May 2000 to March 2010.
Robert ten Hoedt, age 60, has been Executive Vice President
and President, EMEA of the Company since January 2015 and of
Medtronic, Inc. since May 2014. Prior to that, he was Senior Vice
President and President, EMEA and Canada from 2009 to 2014;
Vice President CardioVascular Europe and Central Asia from
2006 to 2009; Vice President and General Manager, Vitatron
from 1999 to 2006; Gastro-Uro leader from 1994 to 1999; and
Marketing Manager, Neurological from 1991 to 1994.
Robert J. White, age 58, is Executive Vice President and
President, Medical Surgical Portfolio. Since 2017, Mr. White has
served as Executive Vice President and Group President of the
Minimally Invasive Therapies Group of Medtronic. Prior to that,
he was Senior Vice President and President, Asia Pacific from
January 2015 to December 2017. He had served as President,
Emerging Markets, President, Respiratory and Monitoring
Solutions and Vice President and General Manager of Patient
Monitoring at Covidien. He also held various leadership positions
at GE Healthcare and IBM. Mr. White is also a current member of
the Board of Directors of Smith & Nephew plc.
John Liddicoat, M.D., age 57, was named Executive Vice
President and President, Americas Region in September 2018.
Dr. Liddicoat joined Medtronic in 2006 as Vice President of Atrial
Fibrillation Technologies. In December of 2006, Dr. Liddicoat was
named Vice President and General Manager of the Structural
Heart Disease Business. Beginning in August 2014, Dr. Liddicoat
served as Senior Vice President and President, Cardiac Rhythm
and Heart Failure.
Sean Salmon, age 56, has been Executive Vice President and
Group President, Diabetes Group of the company since October
2019, and also assumed the role of Executive Vice President and
President, Cardiovascular Portfolio in January 2021. Mr. Salmon
previously served as Senior Vice President and President of
Coronary and Structural Heart Business within the Cardiac and
Vascular Group of the Company beginning in July 2014.
Mr. Salmon is a seasoned leader who has been with Medtronic
since 2004 and spent the past 16 years in increasingly senior
levels of management. Prior to joining Medtronic, Mr. Salmon
worked at CR Bard and Johnson & Johnson.
Brett Wall, age 56, is Executive Vice President and President of
Medtronic’s Neuroscience Portfolio. Mr. Wall previously served
as Senior Vice President and President of the Brain Therapies
division of Medtronic within the Restorative Therapies Group of
the Company from March 2016 to November 2019. Prior to that,
Mr. Wall served as SVP and President of Medtronic’s
Neurovascular business. Prior to joining Medtronic, he served as
Covidien’s SVP and President of Neurovascular as well as Senior
Vice President and President of the International Vascular
Therapies business for Covidien. Mr. Wall also served as Senior
Vice President and President, International at ev3, Inc. From
2000 to 2008, Brett held various marketing and sales positions
with ev3, Inc. and Micro Therapeutics, Inc. Mr. Wall has also
worked at Boston Scientific as Director of Marketing,
Cardiovascular, Asia Pacifica and Marketing Manager, Japan,
from September 1995 to September 2000.
Item 11. Executive Compensation
The sections entitled “Corporate Governance — Director
Compensation,” “Corporate Governance — Committees of the
Board and Meetings,” “Compensation Discussion and Analysis,”
and “Executive Compensation” in Medtronic’s Proxy Statement
for the Company’s 2021 Annual General Meeting of
Shareholders, which will be filed no later than 120 days after
April 30, 2021, are incorporated herein by reference. The section
entitled “Compensation Committee Report” in Medtronic’s
Proxy Statement for the Company’s 2021 Annual General
Meeting of Shareholders, which will be filed no later than 120
days after April 30, 2021, is furnished herein by reference.
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MEDTRONIC PLC 2021 Form 10-K
PART III
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters
Item 12. Security Ownership of Certain Beneficial Owners and
Management and Related Shareholder Matters
The sections entitled “Share Ownership Information – Significant Shareholders,” “Share Ownership Information – Beneficial Ownership
of Management,” and “Executive Compensation — Equity Compensation Plan Information” in Medtronic’s Proxy Statement for the
Company’s 2021 Annual General Meeting of Shareholders, which will be filed no later than 120 days after April 30, 2021, are incorporated
herein by reference.
Item 13. Certain Relationships and Related Transactions, and
Director Independence
The sections entitled “Corporate Governance — Director Independence” and “Corporate Governance — Related Party Transactions
and Other Matters” in Medtronic’s Proxy Statement for the Company’s 2021 Annual General Meeting of Shareholders, which will be filed
no later than 120 days after April 30, 2021, are incorporated herein by reference.
Item 14. Principal Accounting Fees and Services
The sections entitled “Corporate Governance — Committees of the Board and Meetings” and “Audit and Non-Audit Fees” in
Medtronic’s Proxy Statement for the Company’s 2021 Annual General Meeting of Shareholders, which will be filed no later than 120 days
after April 30, 2021, are incorporated herein by reference.
MEDTRONIC PLC 2021 Form 10-K 113
PART IV
Item 15. Exhibits and Financial Statement Schedules
(a) 1. Financial Statement Schedules
Schedule II. Valuation and Qualifying Accounts — years ended April 30, 2021, April 24, 2020, and April 26, 2019.
MEDTRONIC PLC AND SUBSIDIARIES
SCHEDULE II VALUATION AND QUALIFYING ACCOUNTS
Balance at
Beginning of
Fiscal Year
Additions Deductions
Balance at End of
Fiscal Year(in millions)
Charges to
Income
Charges to
Other Accounts
Other Changes
(Debit) Credit
Allowance for doubtful accounts:
Fiscal year ended April 30, 2021 $ 208 $ 128 $ $ (95)
(a)
$ 241
Fiscal year ended April 24, 2020 190 99 (81)
(a)
208
Fiscal year ended April 26, 2019 193 78 (81)
(a)
190
Inventory reserve:
Fiscal year ended April 30, 2021 $ 544 $ 483 $ $ (398)
(b)
$ 629
Fiscal year ended April 24, 2020 521 282 (259)
(b)
544
Fiscal year ended April 26, 2019 452 224 (155)
(b)
521
Deferred tax valuation allowance:
Fiscal year ended April 30, 2021 $ 5,482 $ 342 $ 170
(e)
$ (172)
(d)
$ 5,822
Fiscal year ended April 24, 2020 6,300 119 (6)
(c)
(744)
(d)
5,482
(187)
(e)
Fiscal year ended April 26, 2019 7,166 378 (11)
(c)
(770)
(d)
6,300
(463)
(e)
(a) Primarily consists of uncollectible accounts written off, less recoveries.
(b) Primarily reflects utilization of the inventory reserve.
(c) Reflects the impact from acquisitions and amounts recognized in accumulated other comprehensive income/loss.
(d) Primarily reflects carryover attribute utilization and expiration.
(e) Primarily reflects the effects of currency fluctuations.
All other schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes
thereto.
114
MEDTRONIC PLC 2021 Form 10-K
PART IV
Item 15 Exhibits and Financial Statement Schedules
2. Exhibits
Exhibit No. Description
3.1 Certificate of Incorporation of Medtronic plc (incorporated by reference to Exhibit 3.1 to Medtronic plc’s Current Report on Form 8-K,
filed on January 27, 2015, File No. 001-36820).
3.2 Amended and Restated Memorandum and Articles of Association of Medtronic plc (incorporated by reference to Exhibit 3.2 to
Medtronic plc’s Registration Statement on Form S-3, filed on February 6, 2017, File No. 333-215895).
4.1 Form of Indenture between Medtronic, Inc. and Wells Fargo Bank, National Association regarding 2009 offering (incorporated by
reference to Exhibit 4.1 to Medtronic, Inc.’s Registration Statement on Form S-3, filed on March 9, 2009, File No. 333-157777).
4.2 First Supplemental Indenture, dated March 12, 2009, between Medtronic, Inc. and Wells Fargo Bank, National Association (including the
Forms of Notes thereof) (incorporated by reference to Exhibit 4.1 to Medtronic, Inc.’s Current Report on Form 8-K, filed on March 12,
2009, File No. 001-07707).
4.3 Second Supplemental Indenture, dated March 16, 2010, between Medtronic, Inc. and Wells Fargo Bank, National Association (including
the Forms of Notes thereof) (incorporated by reference to Exhibit 4.1 to Medtronic, Inc.’s Current Report on Form 8-K, filed on
March 16, 2010, File No. 001-07707).
4.4 Third Supplemental Indenture, dated March 15, 2011, between Medtronic, Inc. and Wells Fargo Bank, National Association (including the
Forms of Notes thereof) (incorporated by reference to Exhibit 4.1 to Medtronic, Inc.’s Current report on Form 8-K, filed on March 16,
2011, File No. 001-07707).
4.5 Fourth Supplemental Indenture, dated March 19, 2012, between Medtronic, Inc. and Wells Fargo Bank, National Association (including
the Forms of Notes thereof) (incorporated by reference to Exhibit 4.2 to Medtronic, Inc.’s Current Report on Form 8-K, filed on
March 20, 2012, File No. 001-07707).
4.6 Fifth Supplemental Indenture, dated March 26, 2013, between Medtronic, Inc. and Wells Fargo Bank, National Association (including the
Forms of Notes thereof) (incorporated by reference to Exhibit 4.1 to Medtronic, Inc.’s Current Report on Form 8-K, filed on March 26,
2013, File No. 001-07707).
4.7 Sixth Supplemental Indenture, dated February 27, 2014, between Medtronic, Inc. and Wells Fargo Bank, National Association (including
the Form of Global Note thereof) (incorporated by reference to Exhibit 4.2 to Medtronic, Inc.’s Current Report on Form 8-K, filed on
February 27, 2014, File No. 001-07707).
4.8 Seventh Supplemental Indenture, dated as of January 26, 2015, by and among Medtronic plc, Medtronic, Inc., Medtronic Global
Holdings S.C.A. and Wells Fargo Bank, National Association (incorporated by reference to Exhibit 4.2 to Medtronic plc’s Current Report
on Form 8-K12B, filed on January 27, 2015, File No. 001-36820).
4.9 Indenture, dated December 10, 2014, between Medtronic, Inc. and Wells Fargo Bank, National Association (incorporated by reference
to Exhibit 4.1 to Medtronic, Inc.’s Current Report on Form 8-K filed with the Commission on December 10, 2014, File No. 001-07707).
4.10 First Supplemental Indenture, dated December 10, 2014, between Medtronic, Inc. and Wells Fargo Bank, National Association (including
Form of Floating Rate Senior Notes due 2020, Form of 1.500% Senior Notes due 2018, Form of 2.500% Senior Notes due 2020, Form
of 3.150% Senior Notes due 2022, Form of 3.500% Senior Notes due 2025, Form of 4.375% Senior Notes due 2035 and Form of
4.625% Senior Notes due 2045) (incorporated by reference to Exhibit 4.2 of Medtronic, Inc.’s Current Report on Form 8-K filed with the
Commission on December 10, 2014, File No. 001-07707).
4.11 Second Supplemental Indenture, dated as of January 26, 2015, by and among Medtronic plc and Wells Fargo Bank, National Association
(incorporated by reference to Exhibit 4.3 to Medtronic plc’s Current Report on Form 8-K12B, filed on January 27, 2015, File
No. 001-36820).
4.12 Third Supplemental Indenture, dated as of January 26, 2015, by and among Medtronic Global Holdings S.C.A. and Wells Fargo Bank,
National Association (incorporated by reference to Exhibit 4.4 to Medtronic plc’s Current Report on Form 8-K12B, filed on January 27,
2015, File No. 001-36820).
4.13 Indenture, dated as of October 22, 2007, by and among Covidien International Finance S.A., Covidien Ltd. and Deutsche Bank Trust
Company Americas (incorporated by reference to Exhibit 4.1(a) to Covidien plc’s Current Report on Form 8-K filed on October 22,
2007, File No. 001-33259).
4.14 Fourth Supplemental Indenture, dated as of October 22, 2007, by and among Covidien International Finance S.A., Covidien Ltd. and
Deutsche Bank Trust Company Americas (incorporated by reference to Exhibit 4.1(e) to Covidien plc’s Current Report on Form 8-K
filed on October 22, 2007, File No. 001-33259).
4.15 Fifth Supplemental Indenture, dated as of June 4, 2009, by and among Covidien International Finance S.A., Covidien Ltd., Covidien plc
and Deutsche Bank Trust Company Americas (incorporated by reference to Exhibit 4.1 to Covidien plc’s Current Report on Form
8-K12G3 filed on June 5, 2009, File No. 001-33259).
4.16 Sixth Supplemental Indenture, dated as of June 28, 2010, among Covidien International Finance S.A., Covidien Ltd., Covidien plc and
Deutsche Bank Trust Company Americas (incorporated by reference to Exhibit 4.1 to Covidien plc’s Current Report on Form 8-K filed
on June 28, 2010, File No. 001-33259).
4.17 Seventh Supplemental Indenture, dated as of May 30, 2012, among Covidien International Finance S.A., Covidien Ltd., Covidien plc and
Deutsche Bank Trust Company Americas (incorporated by reference to Exhibit 4.1 to Covidien plc’s Current Report on Form 8-K filed
on May 30, 2012, File No. 001-33259).
4.18 Eighth Supplemental Indenture, dated as of May 16, 2013, among Covidien International Finance S.A., Covidien Ltd., Covidien plc and
Deutsche Bank Trust Company Americas (incorporated by reference to Exhibit 4.1 to Covidien plc’s Current Report on Form 8-K filed
on May 16, 2013, File No. 001-33259).
MEDTRONIC PLC 2021 Form 10-K 115
PART IV
Item 15 Exhibits and Financial Statement Schedules
Exhibit No. Description
4.19 Ninth Supplemental Indenture, dated as of January 26, 2015, by and among Medtronic plc, Medtronic Global Holdings S.C.A., Covidien
public limited company, Covidien International Finance S.A., Covidien Ltd. and Deutsche Bank Trust Company Americas (incorporated
by reference to Exhibit 4.5 to Medtronic plc’s Current Report on Form 8-K12B, filed on January 27, 2015, File No. 001-36820).
4.20 Senior Indenture, dated as of March 28, 2017, by and among Medtronic plc, Medtronic Global Holdings S.C.A., Medtronic, Inc., and Wells
Fargo Bank, N.A. (incorporated by reference to Exhibit 4.1 to Medtronic plc’s Current Report on Form 8-K, filed on March 28, 2017, File
No. 001-36820).
4.21 First Supplemental Indenture, dated as of March 28, 2017, by and among Medtronic plc, Medtronic Global Holdings S.C.A., Medtronic,
Inc., and Wells Fargo Bank, N.A. (incorporated by reference to Exhibit 4.2 to Medtronic plc’s Current Report on Form 8-K, filed on
March 28, 2017, File No. 001-36820).
4.22 Second Supplemental Indenture, dated as of March 7, 2019, by and among Medtronic plc, Medtronic Global Holdings S.C.A., Medtronic,
Inc., Wells Fargo Bank, N.A., and Elavon Financial Services DAC, UK Branch (incorporated by reference to Exhibit 4.1 to Medtronic plc’s
Current Report on Form 8-K, filed on March 7, 2019, File No. 001-36820).
4.23 Third Supplemental Indenture, dated as of July 2, 2019, among Medtronic Global Holdings S.C.A., Medtronic, Inc. and Medtronic plc,
Wells Fargo Bank, N.A., as trustee, and Elavon Financial Services DAC (incorporated by reference to Exhibit 4.1 to Medtronic plc’ Current
Report on Form 8-K, filed July 2, 2019, File No. 001-36820).
4.24 Fourth Supplemental Indenture, dated as of September 29, 2020, among Medtronic Global Holdings S.C.A., Medtronic, Inc. and
Medtronic plc, Wells Fargo Bank, N.A., as trustee, and Elavon Financial Services DAC, as paying agent (including the forms of the 2023
Notes, the 2025 Notes, the 2028 Notes, the 2032 Notes, the 2040 Notes and the 2050 Notes) (incorporated by reference to Exhibit 4.1
to Medtronic plc’ Current Report on Form 8-K, filed September 29, 2020, File No. 001-36820).
#4.25 Description of Registrant’s Securities.
10.1 Amended and Restated Credit Agreement, dated as of December 12, 2018, by and among Medtronic Global Holdings, SCA, certain
subsidiaries named therein, Medtronic, Inc., Medtronic PLC, the lenders from time to time party thereto, and Bank of America, N.A. as
Administration Agent (incorporated by reference to Exhibit 10.1 to Medtronic plc’s Current Report on Form 8-K, filed on December 13,
2018, File No. 001-36820).
10.2 Amendment No. 1 and Extension Agreement to the Amended and Restated Credit Agreement, dated as of December 12, 2019,
among Medtronic Global Holdings S.C.A., Medtronic, Inc., Medtronic PLC, the Lenders party thereto and Bank of America, N.A., as
Administrative Agent (incorporated by reference to Exhibit 10.1 to Medtronic plc’s Current Report on Form 10-Q, filed on February 28,
2020, File No. 001-36820).
10.3 Term Loan Agreement, dated as of May 12, 2020, among Medtronic Global Holdings S.C.A., Medtronic, Inc., Medtronic PLC, the
Lenders party thereto and Mizuho Bank, LTD., as Administrative Agent (incorporated by reference to Exhibit 10.1 to Medtronic plc’s
Current Report on Form 8-K, filed on May 12, 2020, File No. 001-36820).
10.4 Form of Deed of Indemnification (incorporated by reference to Exhibit 10.1 to Medtronic plc’s Current Report on Form 8-K12B, filed on
January 27, 2015, File No. 001-36820).
10.5 Form of Indemnification Agreement (incorporated by reference to Exhibit 10.2 to Medtronic plc’s Current Report on Form 8-K12B, filed
on January 27, 2015, File No. 001-36820).
*10.6 Change of Control Severance Plan—Section 16B Officers (as amended and restated as of January 26, 2015) (incorporated by
reference to Exhibit 10.14 to Medtronic plc’s Current Report on Form 8-K, filed on January 27, 2015, File No. 001-36820).
*10.7 Letter Agreement by and between Medtronic, Inc. and Carol Surface dated August 22, 2013 (incorporated by reference to Exhibit 10.44
to Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 25, 2014, filed on June 20, 2014, File No. 001-07707).
*10.8 Letter Agreement by and between Medtronic, Inc. and Bradley E. Lerman dated May 2, 2014 (incorporated by reference to Exhibit 10.4
of Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended July 25, 2014, filed on August 29, 2014, File No. 001-07707).
*10.9 Letter Agreement by and between Medtronic, Inc. and Karen Parkhill dated May 2, 2016 (incorporated by reference to Exhibit 10.1 to
Medtronic, plc’s Current Report on Form 8-K, filed on May 4, 2016, File No. 001-36820).
*10.10 Office of Chairman and Chief Executive Officer Letter Agreement (incorporated by reference to Exhibit 10.1 to Medtronic plc’s
Quarterly Report on Form 10-Q, filed on December 3, 2019, File No. 001-36820).
*10.11 Form of Offer Letter Amendment (incorporated by reference to Exhibit 10.25 to Medtronic plc’s Quarterly Report on Form 10-Q for
the quarter ended January 23, 2015, filed on February 27, 2015, File No. 001-36820).
*10.12 1998 Outside Director Stock Compensation Plan (as amended and restated effective as of January 1, 2008) (incorporated by reference
to Exhibit 10.3 to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended January 25, 2008, filed on, filed on March 4,
2008, File No. 001-07707).
*10.13 Amendment to the 1998 Outside Director Stock Compensation Plan (incorporated by reference to Exhibit 10.2 to Medtronic plc’s
Current Report on Form 8-K, filed on January 27, 2015, File No. 001-36820).
*10.14 2003 Long-Term Incentive Plan (as amended and restated effective January 1, 2008) (incorporated by reference to Exhibit 10.4 to
Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended January 28, 2008, filed on March 4, 2008, File No. 001-07707).
*10.15 Amendment to the 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.3 to Medtronic plc’s Current Report on
Form 8-K, filed on January 27, 2015, File No. 001-36820).
*10.16 Form of Restricted Stock Award Agreement under 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.3 to
Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended January 28, 2005, filed on March 7, 2005, File No. 001-07707).
*10.17 Form of Non-Qualified Stock Option Agreement under 2003 Long-Term Incentive Plan (four year vesting) (incorporated by reference
to Exhibit 10.1 to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended January 28, 2005, filed on March 7, 2005, File
No. 001-07707).
116 MEDTRONIC PLC 2021 Form 10-K
PART IV
Item 15 Exhibits and Financial Statement Schedules
Exhibit No. Description
*10.18 Form of Non-Qualified Stock Option Agreement under 2003 Long-Term Incentive Plan (immediate vesting) (incorporated by reference
to Exhibit 10.2 to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended January 28, 2005, filed on March 7, 2005, File
No. 001-07707).
*10.19 Form of Restricted Stock Units Award Agreement under 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.20 to
Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 29, 2005, filed on June 29, 2005, File No. 001-07707).
*10.20 Form of Performance Share Award Agreement under 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.21 to
Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 29, 2005, filed on June 29, 2005, File No. 001-07707).
*10.21 Form of Non-Qualified Stock Option Agreement under 2003 Long-Term Incentive Plan effective June 22, 2006 (incorporated by
reference to Exhibit 10.23 to Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 28, 2006, filed on June 28, 2006, File
No. 001-07707).
*10.22 Form of Restricted Stock Award Agreement under 2003 Long-Term Incentive Plan effective June 22, 2006 (incorporated by reference
to Exhibit 10.24 to Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 28, 2006, filed on June 28, 2006, File
No. 001-07707).
*10.23 Form of Restricted Stock Unit Award Agreement under 2003 Long-Term Incentive Plan effective June 22, 2006 (incorporated by
reference to Exhibit 10.25 to Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 28, 2006, filed on June 28, 2006, File
No. 001-07707).
*10.24 Form of Performance Award Agreement under 2003 Long-Term Incentive Plan effective June 22, 2006 (incorporated by reference to
Exhibit 10.26 to Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 28, 2006, filed on June 28, 2006, File
No. 001-07707).
*10.25 Form of Restricted Stock Award Agreement under 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.3 to
Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended October 26, 2007, filed on December 4, 2007, File
No. 001-07707).
*10.26 Form of Restricted Stock Unit Award Agreement under 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.4 to
Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended October 26, 2007, filed on December 4, 2007, File
No. 001-07707).
*10.27 Form of Non-Qualified Stock Option Agreement under 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.39 to
Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 25, 2008, filed on June 24, 2008, File No. 001-07707).
*10.28 Form of Restricted Stock Unit Award Agreement under 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.40 to
Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 25, 2008, filed on June 24, 2008, File No. 001-07707).
*10.29 Form of Restricted Stock Unit Award Agreement under 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.41 to
Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 25, 2008, filed on June 24, 2008, File No. 001-07707).
*10.30 Israeli Amendment to the 2003 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.5 to Medtronic, Inc.’s Quarterly
Report on Form 10-Q for the quarter ended January 25, 2008, filed on March 4, 2008, File No. 001-07707).
*10.31 2008 Stock Award and Incentive Plan (as amended and restated effective August 27, 2009) (incorporated by reference to Exhibit 10.2
to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended October 30, 2009, filed on December 9, 2009, File
No. 001-07707).
*10.32 Amendment to the 2008 Stock Award and Incentive Plan (incorporated by reference to Exhibit 10.4 to Medtronic plc’s Current Report
on Form 8-K, filed on January 27, 2015, File No. 001-36820).
*10.33 Form of Restricted Stock Unit Award Agreement under 2008 Stock Award and Incentive Plan (incorporated by reference to Exhibit 10.2
to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended July 25, 2008, filed on September 3, 2008, File
No. 001-07707).
*10.34 Form of Restricted Stock Award Agreement under 2008 Stock Award and Incentive Plan (incorporated by reference to Exhibit 10.3 to
Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended July 25, 2008, filed on September 3, 2008, File No. 001-07707).
*10.35 Form of Restricted Stock Award Agreement under 2008 Stock Award and Incentive Plan (incorporated by reference to Exhibit 10.4 to
Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended July 25, 2008, filed on September 3, 2008, File No. 001-07707).
*10.36 Form of Restricted Stock Unit Award Agreement under 2008 Stock Award and Incentive Plan (incorporated by reference to Exhibit 10.5
to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended July 25, 2008, filed on September 3, 2008, File
No. 001-07707).
*10.37 Form of Non-Qualified Stock Option Agreement under 2008 Stock Award and Incentive Plan (incorporated by reference to Exhibit 10.6
to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended July 25, 2008, filed on September 3, 2008, File
No. 001-07707).
*10.38 Terms of Non-Employee Director Compensation under 2008 Stock Award and Incentive Plan (incorporated by reference to Exhibit
10.42 to Medtronic, Inc.’s Annual Report on Form 10-K for the year ended April 27, 2012, filed on June 26, 2012, File No. 001-07707).
*10.39 Form of Non-Employee Director Initial Option Agreement under 2008 Stock Award and Incentive Plan (incorporated by reference to
Exhibit 10.1 to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended October 24, 2008, filed on December 3, 2008,
File No. 001-07707).
*10.40 Form of Non-Employee Director Annual Option Agreement under 2008 Stock Award and Incentive Plan (incorporated by reference to
Exhibit 10.2 to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended October 24, 2008, filed on December 3, 2008,
File No. 001-07707).
MEDTRONIC PLC 2021 Form 10-K 117
PART IV
Item 15 Exhibits and Financial Statement Schedules
Exhibit No. Description
*10.41 Form of Non-Employee Director Deferred Unit Award Agreement under 2008 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.3 to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended October 24, 2008, filed on
December 3, 2008, File No. 001-07707).
*10.42 Form of Non-Employee Restricted Stock Unit Award Agreement under Amended and Restated 2013 Stock Award and Incentive Plan
(incorporated by reference to Exhibit 10.65 to Medtronic plc’s Annual Report on Form 10-K for the year ended April 24, 2015, filed on
June 23, 2015, File No. 001-36820).
*10.43 Israeli Amendment to the Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by reference to Exhibit 10.10 to
Medtronic plc’s Current Report on Form 8-K, filed on January 27, 2015, File No. 001-36820).
*10.44 Form of Restricted Stock Award Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.1 to Medtronic plc’s Quarterly Report on Form 10-K for the quarter ended July 28, 2017, filed on September 1,
2017, File No. 001-36820).
*10.45 Medtronic plc Amended and Restated 2013 Stock Award and Incentive Plan (as amended and restated generally effective December 8,
2017) (incorporated by reference to Exhibit 10.1 to Medtronic plc’s Current Report on Form 8-K, filed on December 12, 2017, File
No. 001-36820).
*10.46 Form of Non-qualified Stock Option Agreement Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.50 to Medtronic plc’s Annual Report on Form 10-K, filed June 22, 2018, File No. 001-36820).
*10.47 Form of Restricted Stock Unit Award Agreement Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.51 to Medtronic plc’s Annual Report on Form 10-K, filed June 22, 2018, File No. 001-36820).
*10.48 Form of Restricted Stock Award Agreement Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by reference
to Exhibit 10.52 to Medtronic plc’s Annual Report on Form 10-K, filed June 22, 2018, File No. 001-36820)
*10.49 Form of Long Term Performance Award Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated
by reference to Exhibit 10.53 to Medtronic plc’s Annual Report on Form 10-K, filed June 22, 2018, File No. 001-36820).
*10.50 Form of Non-Qualified Stock Option Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.31 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended January 23, 2015, filed on
February 27, 2015, File No. 001-36820).
*10.51 Form of Performance Share Unit Award Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated
by reference to Exhibit 10.1 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended October 30, 2020, filed on
December 3, 2020, File No. 001-36820).
*10.52 Form of Non-Employee Director Deferred Unit Award Agreement under the 2008 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.3 to Medtronic, Inc.’s Quarterly Report on Form 10-Q for the quarter ended October 24, 2008, filed on
December 3, 2008, File No. 001-07707).
*10.53 Form of Non-Qualified Stock Option Agreement under 2013 Stock Award and Incentive Plan (incorporated by reference to Exhibit 10.2
to Medtronic, Inc.’s Current Report on Form 8-K, filed on August 27, 2013, File No. 001-07707).
*10.54 Form of Restricted Stock Unit Award Agreement (U.S. Employees) under 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.3 to Medtronic, Inc.’s Current Report on Form 8-K, filed on August 27, 2013, File No. 001-07707).
*10.55 Form of Restricted Stock Unit Award Agreement (Non-U.S. Employees) under 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.4 to Medtronic, Inc.’s Current Report on Form 8-K, filed on August 27, 2013, File No. 001-07707).
*10.56 Form of Restricted Stock Unit Award Agreement (Time-Based) under 2013 Stock Award and Incentive Plan (incorporated by reference
to Exhibit 10.5 to Medtronic, Inc.’s Current Report on Form 8-K, filed on August 27, 2013, File No. 001-07707).
*10.57 Form of Restricted Stock Unit Award Agreement (Israeli-Employees) under 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.8 to Medtronic, Inc.’s Current Report on Form 8-K, filed on August 27, 2013, File No. 001-07707).
*10.58 Form of Non-Qualified Stock Option Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.48 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended January 23, 2015, filed on
February 27, 2015, File No. 001-36820).
*10.59 Form of Restricted Stock Unit Award Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.49 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended January 23, 2015, filed on
February 27, 2015, File No. 001-36820).
*10.60 Form of Restricted Stock Unit Award Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.50 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended January 23, 2015, filed on
February 27, 2015, File No. 001-36820).
*10.61 Form of Restricted Stock Unit Award Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.51 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended January 23, 2015, filed on
February 27, 2015, File No. 001-36820).
*10.62 Form of Stock Option Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by reference to
Exhibit 10.53 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended January 23, 2015, filed on February 27, 2015, File
No. 001-36820).
*10.63 Form of Restricted Stock Unit Award Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.54 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended January 23, 2015, filed on
February 27, 2015, File No. 001-36820).
118 MEDTRONIC PLC 2021 Form 10-K
PART IV
Item 16 Form 10-K Summary
Exhibit No. Description
*10.64 Form of Restricted Stock Award Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.69 to Medtronic plc’s Annual Report on Form 10-K for the year ended April 24, 2020, filed on June 19, 2020, File
No. 001-36820).
*10.65 Form of Non-Qualified Stock Option Agreement under Amended and Restated 2013 Stock Award and Incentive Plan (incorporated by
reference to Exhibit 10.70 to Medtronic plc’s Annual Report on Form 10-K for the year ended April 24, 2020, filed on June 19, 2020, File
No. 001-36820).
*10.66 Medtronic plc 2014 Amended and Restated Employees Stock Purchase Plan (incorporated by reference to Exhibit 10.8 to Medtronic
plc’s Current Report on Form 8-K, filed on January 27, 2015, File No. 001-36820).
*10.67 Medtronic plc Incentive Plan (as amended and restated effective January 26, 2015) (incorporated by reference to Exhibit 10.11 to
Medtronic plc’s Current Report on Form 8-K, filed on January 27, 2015, File No. 001-36820).
*10.68 Medtronic plc Supplemental Executive Retirement Plan (as restated generally effective January 26, 2015) (incorporated by reference to
Exhibit 10.15 to Medtronic plc’s Current Report on Form 8-K, filed on January 27, 2015, File No. 001-36820).
*10.69 Medtronic Non-Qualified Retirement Plan Supplemental (restated November 6, 2020, and formerly known as the Supplemental
Executive Retirement Plan) (incorporated by reference to Exhibit 10.3 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter
ended October 30, 2020, filed on December 3, 2020, File No. 001-36820).
*10.70 Medtronic plc Savings and Investment Plan (as amended and restated generally effective January 26, 2015) (incorporated by reference
to Exhibit 4.22 to Medtronic plc’s Registration Statement on Form S-8 filed on January 28, 2015, File No. 333-201737).
*10.71 Medtronic plc Puerto Rico Employees’ Savings and Investment Plan (as amended and restated generally effective January 26, 2015)
(incorporated by reference to Exhibit 4.23 to Medtronic plc’s Registration Statement on Form S-8 filed on January 28, 2015, File
No. 333-201737).
*10.72 Medtronic plc Capital Accumulation Plan Deferral Program (as amended and restated generally effective January 26, 2015)
(incorporated by reference to Exhibit 10.13 to Medtronic plc’s Current Report on Form 8-K, filed on January 27, 2015, File
No. 001-36820).
*10.73 Capital Accumulation Plan Deferral Program (as amended and restated generally effective January 1, 2017) (incorporated by reference
to Exhibit 10.1 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended October 28, 2016, filed on December 5, 2016,
File No. 001-36820).
*10.74 Amended and Restated Covidien Supplemental Savings and Retirement Plan (restated November 6, 2020) (incorporated by reference
to Exhibit 10.2 to Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended October 30, 2020, filed on December 3, 2020,
File No. 001-36820).
*10.75 Medtronic Capital Accumulation Plan Deferral Program (restated November 6, 2020) (incorporated by reference to Exhibit 10.4 to
Medtronic plc’s Quarterly Report on Form 10-Q for the quarter ended October 30, 2020, filed on December 3, 2020, File
No. 001-36820).
#21 List of Subsidiaries of Medtronic plc.
#22 List of Senior Notes, Issuers and Guarantors.
#23 Consent of Independent Registered Public Accounting Firm.
#24 Power of Attorney.
#31.1 Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
#31.2 Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
#32.1 Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
#32.2 Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
#101.SCH XBRL Taxonomy Extension Schema Document
#101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
#101.DEF XBRL Taxonomy Extension Definition Linkbase Document
#101.LAB XBRL Taxonomy Extension Label Linkbase Document
#101.PRE XBRL Taxonomy Extension Presentation Linkbase Document
#104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
* Exhibits that are management contracts or compensatory plans or arrangements.
# Filed herewith
Item 16. Form 10-K Summary
Registrants may voluntarily include a summary of information required by Form 10-K under this Item 16. The Company has not elected
to include such summary information.
MEDTRONIC PLC 2021 Form 10-K 119
PART IV
Item 16 Form 10-K Summary
Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly authorized.
Medtronic plc
Dated: June 25, 2021 By:
/s/ Geoffrey S. Martha
Geoffrey S. Martha
Chairman and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, the report has been signed below by the following persons on
behalf of the registrant and in the capacities and on the dates indicated.
Medtronic plc
Dated: June 25, 2021 By:
/s/ Geoffrey S. Martha
Geoffrey S. Martha
Chairman and Chief Executive Officer
(Principal Executive Officer)
Dated: June 25, 2021 By:
/s/ Karen L. Parkhill
Karen L. Parkhill
Executive Vice President and
Chief Financial Officer
(Principal Financial and
Accounting Officer)
Directors
Richard H. Anderson*
Craig Arnold*
Scott C. Donnelly*
Andrea J. Goldsmith, PH.D.*
Randall J. Hogan,*
Michael O. Leavitt*
James T. Lenehan*
Kevin E. Lofton*
Geoffrey S. Martha
Elizabeth G. Nabel, M.D.*
Denise M. O’Leary*
Kendall J. Powell*
*Bradley E. Lerman, by signing his name hereto, does hereby sign this document on behalf of each of the above named directors of the registrant
pursuant to powers of attorney duly executed by such persons.
Dated: June 25, 2021 By:
/s/ Bradley E. Lerman
Bradley E. Lerman
120 MEDTRONIC PLC 2021 Form 10-K
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