Medtronic (MDT) 10-K risk factor changes: FY2020 vs FY2019

[removed: | • |] [added: -] product performance and reliability, [removed: |]

[removed: | • |] [added: -] product technology and innovation, [removed: |]

[removed: | • |] [added: -] product quality and safety, [removed: |]

[removed: | • |] [added: -] breadth of product lines, [removed: |]

[removed: | • |] [added: -] product support services, [removed: |]

[removed: | • |] [added: -] customer support, [removed: |]

[removed: | • |] [added: -] cost-effectiveness and price, [removed: |]

[removed: | • |] [added: -] reimbursement approval from [removed: health care] [added: healthcare] insurance providers, and [removed: |]

[removed: | • |] [added: -] changes to the regulatory environment. [removed: |]

In the current environment of managed care, consolidation among [removed: health care] [added: healthcare] providers, increased competition, and declining reimbursement rates, we have been increasingly required to compete on the basis of price.

[removed: We purchase many of] the components, raw materials and services needed to manufacture these products from numerous suppliers in various countries.

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 [added: disasters such as hurricanes, tornadoes or wildfires, property damage from riots, and other environmental factors and the impact of epidemics or pandemics, such as COVID-19, 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 [removed: processes.][added: processes, and we are currently adversely impacted by, and expect to 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.]

[removed: | • |] [added: -] take a significant amount of time, [removed: |]

[removed: | • |] [added: -] require the expenditure of substantial resources, [removed: |]

[removed: | • |] [added: -] involve stringent clinical and pre-clinical testing, as well as increased post-market surveillance, [removed: |]

[removed: | • |] [added: -] involve modifications, repairs or replacements of our products, and [removed: |]

[removed: | • |] [added: -] limit the proposed uses of our products. [removed: |]

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 [removed: require us to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health.]

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 [removed: health care] [added: healthcare] providers, regulatory compliance and product promotional practices, we cannot predict the timing, outcome or impact of any such investigations.

In the European Union, for example, a new Medical Device Regulation was published in 2017 which, when it enters into [removed: full] force in [removed: 2020,] [added: May 2021,] will include significant additional premarket and post-market requirements.

Our failure to comply with laws and regulations relating to reimbursement of [removed: health care] [added: 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 [removed: health care] [added: 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.

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 [removed: care] [added: are] goods and services, including laws and regulations related to kickbacks, false claims, self-referrals and [removed: health care] [added: healthcare] fraud.

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 [removed: impact] [added: impacting] our ability to sell current or future [removed: products, or prohibit us from enforcing our patent and other proprietary rights against others.][added: products.]

We are substantially dependent on patent and other proprietary rights and rely on a combination of patents, [added: trademarks, tradenames, copyrights,] trade secrets, and [added: agreements (such as employee,] non-disclosure and non-competition [removed: agreements] [added: agreements)] to protect our [added: business and] proprietary intellectual property.

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 [removed: prohibit us from enforcing] [added: that enforcement actions to protect] our patent and proprietary rights against [removed: others,] [added: 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, [added: trademarks, tradenames, copyrights,] trade secrets or [removed: other] agreements [added: (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 [removed: insufficiently broad] [added: 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 [removed: these] [added: such] licenses may not be available on reasonable terms or at all.

In addition, the laws of certain countries in which we market [added: 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 [removed: position in those countries.][added: position.]

[removed: Quality is extremely important to us and our customers due to the serious and costly consequences of product failure, and our] [added: Our] business exposes us to potential product liability risks that are inherent in the design, manufacture, and marketing of medical devices.

[removed: Health care] [added: Healthcare] policy changes may have a material adverse effect on us.

In response to perceived increases in [removed: health care] [added: healthcare] costs in recent years, there have been and continue to be proposals by [removed: the federal government, state] [added: several] governments, regulators and third-party payers [added: globally, including the U.S. federal and state governments,] to control these costs and, more generally, to reform [removed: the health care system,] [added: healthcare systems,] including U.S. [removed: health care] [added: healthcare] reform legislation.

We have experienced, and may continue to experience, decreasing prices for [added: 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.

We intend to continue to expand our operations and to pursue growth opportunities outside the U.S., especially in emerging [removed: markets, which could expose us to additional and greater risks.][added: markets.]

[removed: | • |] [added: -] fluctuations in currency exchange rates, [removed: |]

[removed: | • |] [added: -] healthcare reform legislation, [removed: |]

[removed: | • |] [added: -] 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, [removed: |]

[removed: | • |] [added: -] local product preferences and product requirements, [removed: |]

The novel coronavirus disease 2019 (COVID-19) has had, and we expect will continue to have, an adverse effect on our business, results of operations, financial condition and cash flows, the nature and extent of which 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 global spread of COVID-19, including corresponding preventative and precautionary measures that we and other businesses, communities and governments are taking to mitigate the spread of the disease, has led to unprecedented restrictions on, disruptions in, and other related impacts on business and personal activities.

Further, in addition to travel restrictions put in place in early 2020, countries, states and governments may continue to close borders, impose prolonged quarantines or other restrictions and requirements on travel, and further limit our ability to conduct business in-person as we did prior to COVID-19, requiring businesses, including our business, to use alternative methods of communication.

It is likely the COVID-19 pandemic will cause an economic slowdown of potentially extended duration, and it is possible that it could cause a global recession.

Together with the preventative and precautionary measures being taken, as well as the corresponding need to adapt to new and different methods of communication and conducting business, COVID-19 is having, and will likely continue to have, an adverse impact on significant aspects of our Company and business, including on demand for and supply of our products, operations, supply chains and distribution systems, our ability to research and develop and bring to market new products and services, and our ability to generate cash flow, and may have an adverse impact on our ability to access capital.

Some of our products are particularly 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 suspended or postponed in many of the markets where our products are marketed and sold, which has caused a reduction in sales of these products.

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 a broad resumption of deferrable medical procedures and, to the extent individuals and hospital systems continue to 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, cash flows, financial condition and results of operations would continue to be negatively affected.

Further, the COVID-19 pandemic is straining hospital systems around the world, resulting in adverse financial impacts to those systems that could result in reduced future expenditures for capital equipment and other products and services we provide, as well as disruption of product launches of our recently approved products.

Clinical trials generally have suspended enrollment due to facility closures and governmental restrictions, which we expect will delay the results from those clinical trials and will impact our ability to timely develop and bring to market new products.

In addition, a significant number of our global suppliers, vendors, distributors and manufacturing facilities have been adversely affected by the COVID-19 pandemic, including by adversely impacting the ability of their employees to get to their places of work and maintain the continuity of their on-site operations.

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 our products in a timely manner or at all, which could harm our reputation, future sales and profitability.

In addition, 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.

In addition, 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 members of our management team, as well as the ability of our third-party suppliers, manufacturers, distributors and vendors to retain their key employees.

To the extent our management or other personnel are impacted in significant numbers by COVID-19 and are not available to perform their job duties, we could experience delays in, or the suspension of, our manufacturing operations, research and product development activities, regulatory work streams, clinical development programs and other important commercial functions.

While the impact of COVID-19 has had, and we expect it to 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.

We purchase many of

require us to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health.

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.

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.

Operations in different countries including emerging markets could expose us to additional and greater risks and potential costs, including:

The escalating 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 seven 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.

One example would be stronger “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.

In addition, COVID-19, and the responses of business and governments to COVID-19, have 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.

The ultimate cost of

In addition, as a result of the COVID-19 pandemic, our access to these professionals has been limited, 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.

Further, a greater number of our employees are working remotely in response to the COVID-19 pandemic and related government actions, which could expose us to greater risks related to cybersecurity and our information technologies systems.

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.

The OECD announced its intention to expand the scope of BEPS in March 2018 and in January 2019 they issued a short policy note that announced agreement on the way forward for developing a long term solution to the tax challenges thrown up by the global digital economy and is commonly referred to as BEPS2.0.

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disasters such as hurricanes, tornadoes or wildfires, and other environmental factors, could lead to launch delays, product shortage, unanticipated costs, lost revenues and damage to our reputation.

Operations in countries outside of the U.S. are accompanied by certain risks.

Our profitability and global operations are, and will continue to be, subject to a number of risks and potential costs, including:

On June 23, 2016, the U.K. held a referendum in which voters approved an exit from the E.U., commonly referred to as “Brexit”.

As a result of the referendum, the British government began negotiations with the E.U. on the terms of the U.K.’s future relationship with the E.U. Brexit was due to take place on March 29, 2019, however, the inability to agree on the exact terms of the future relationship have delayed Brexit and led to continued uncertainty about Brexit’s potential impacts on the Company.

It is possible that as a result of Brexit there will be greater restrictions on imports and exports between the U.K. and E.U. countries and increased regulatory complexities that could adversely impact the Company.

Similarly, from time to time proposals are made in the U.S. to significantly change existing trade agreements and relationships between the U.S. and other countries, although we cannot currently predict whether or how these changes will be implemented over time.

primarily those used in manufacturing and sterilization processes.

pace with continuing changes in information processing technology will be successful or that additional systems issues will not arise in the future.

In addition, the government in Switzerland is currently considering tax reform legislation, the results of which could have a material impact on our business, financial condition, results of operations, and cash flows.

One specific change is a requirement for increased disclosures of financial information on a local and global basis.

Based on the rules for determining share ownership under Section 7874 of the Code, Medtronic, Inc.’s

Accordingly, our articles of association contain, as permitted by Irish company law, provisions authorizing the board to issue new shares, and to disapply statutory preemption rights.

The authorization of the directors to issue shares and the disapplication of statutory preemption rights must both be renewed by the shareholders at least every five years, and our current authorizations are due to expire in January 2020.

You should read this discussion and analysis along with our consolidated financial statements and related notes thereto at April [removed: 26, 2019] [added: 24, 2020] and April [removed: 27, 2018] [added: 26, 2019] and for each of the three fiscal years ended April [added: 24, 2020 (fiscal year 2020), April] 26, 2019 (fiscal year 2019), [added: and] April 27, 2018 (fiscal year 2018), [removed: and April 28, 2017 (fiscal year 2017),] which are presented within "Item 8.

As presented in the GAAP to Non-GAAP Reconciliations section below, our non-GAAP financial measures exclude the impact of certain charges or [removed: gains] [added: 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).

The [removed: table below presents net income attributable to Medtronic and] [added: following is a summary of revenue,] diluted earnings per [removed: share] [added: share, and cash flow] for fiscal years [removed: 2019, 2018,] [added: 2020] and [removed: 2017:][added: 2019:]

| | | [removed: Fiscal] [added: | Net Sales by Fiscal] Year | | | | | | | | | | | | [added: | | | | | | | | | | | |] Percent Change | | | | | [added: | | | |]

[removed: GAAP] [added: GAAP] to 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 [removed: 2019, 2018,] [added: 2020] and [removed: 2017:][added: 2019:]

| | [added: | |] Fiscal year ended April 26, 2019 | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| (in millions, except per share data) | [added: | |] Income Before Income Taxes | | | | [added: | |] Income Tax [added: (Benefit)] Provision | | | | [added: | |] Net Income Attributable to Medtronic | | | | [added: | |] Diluted EPS [removed: (1)] [added: (1)] | | | | [added: | |] Effective Tax Rate | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

| GAAP | [added: | |] $ | 5,197 | | | [added: | |] $ | 547 | | | [added: | |] $ | 4,631 | | | [added: | |] $ | 3.41 | | | [added: | |] 10.5 | [added: |] % | [added: | | | | | | | | | | | | | | | | | | | | | | | |]

| Non-GAAP Adjustments: | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| Restructuring and associated costs (2) | [added: | |] 407 | | | | [added: | |] 66 | | | | [added: | |] 341 | | | | [added: | |] 0.25 | | | | [added: | |] 16.2 | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

| Acquisition-related items (3) | [added: | |] 88 | | | | [added: | |] 16 | | | | [added: | |] 72 | | | | [added: | |] 0.05 | | | | [added: | |] 18.2 | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

| Certain litigation charges | [added: | |] 166 | | | | [added: | |] 24 | | | | [added: | |] 142 | | | | [added: | |] 0.10 | | | | [added: | |] 14.5 | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

| (Gain)/loss on minority investments (4) | [removed: (62] | | [removed: )] [added: (62)] | | [added: | | | |] 3 | | | | [removed: (65] | | [removed: )] [added: (65)] | | [removed: (0.05] | | [removed: )] | | [removed: (4.8] [added: (0.05)] | [removed: )] | [added: | | | | (4.8) | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| Debt tender premium and other charges [removed: (5)] [added: (10)] | [added: | |] 457 | | | | [added: | |] 113 | | | | [added: | |] 344 | | | | [added: | |] 0.25 | | | | [added: | |] 24.7 | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

| IPR&D charges [removed: (6)] [added: (8)] | [added: | |] 58 | | | | [added: | |] 9 | | | | [added: | |] 49 | | | | [added: | |] 0.04 | | | | [added: | |] 15.5 | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

| Exit of businesses (7) | [added: | |] 149 | | | | [added: | |] 31 | | | | [added: | |] 118 | | | | [added: | |] 0.09 | | | | [added: | |] 20.8 | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

| Amortization of intangible assets | [added: | |] 1,764 | | | | [added: | |] 267 | | | | [added: | |] 1,497 | | | | [added: | |] 1.10 | | | | [added: | |] 15.1 | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

| Certain tax adjustments, net [removed: (8)] [added: (11)] | [added: | |] — | | | | [added: | |] 40 | | | | [removed: (40] | | [removed: )] [added: (40)] | | [removed: (0.03] | | [removed: )] | | [added: (0.03) | | | | | |] — | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

| Non-GAAP | [added: | |] $ | 8,224 | | | [added: | |] $ | 1,116 | | | [added: | |] $ | 7,089 | | | [added: | |] $ | 5.22 | | | [added: | |] 13.6 | [added: |] % | [added: | | | | | | | | | | | | | | | | | | | | | | | |]

| | [added: | |] Fiscal year ended April [removed: 27, 2018] [added: 24, 2020] | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| Certain litigation charges | [removed: 61] | | | | [removed: 8] | [added: 313] | | | [removed: 53] | | | [added: 166] | [removed: 0.04] | | | | [removed: 13.1] | | [added: | | | | | | | |]

| Contribution to Medtronic Foundation | [added: | |] 80 | | | | [removed: 26] | | [added: 18] | | [removed: 54] | | | | [removed: 0.04] [added: 62] | | | | [removed: 32.5] | | [added: 0.05 | | | | | | 22.5 | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| Certain tax adjustments, net [removed: (16)] [added: (9)] | [added: | |] — | | | | [removed: (1,907] | | [removed: )] [added: 1,242] | | [removed: 1,907] | | | | [removed: 1.39] [added: (1,242)] | | | | [added: | | (0.92) | | | | | |] — | | [added: | | | | | | | | | | | | | | | | | | | | | | | | |]

[removed: | (1) | Amounts] [added: (1)Amounts] in this column have been intentionally rounded to the nearest $0.01 and, therefore, may not sum. [removed: |]

[removed: | (2) | Associated] [added: (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. [removed: |]

[removed: | (3) | The] [added: (3)The] charges [added: primarily] include [removed: unvested stock option payouts and investment banker and other transaction fees, along with integration-related] costs incurred in connection with [removed: the Covidien acquisition] [added: legacy-Covidien enterprise resource planning deployment activities, business combination related costs,] and changes in [removed: the] fair value of contingent consideration. [removed: |]

[removed: | (4) | Effective in fiscal year 2019, we] [added: (4)We] exclude unrealized and realized gains and losses on our minority investments as we do not believe [removed: that] these components of income or expense have a direct correlation to our ongoing or future business operations. [removed: |]

[removed: | (5) | The net charge,] [added: (10)The charges,] which [removed: includes] [added: include] $485 million recognized in *interest expense* and ($28 million) recognized in *other operating expense, [removed: net*,] [added: net,*] primarily relates to the early redemption of approximately $6.4 billion of Medtronic Inc. and CIFSA senior notes. [removed: |]

[removed: | (6) | The] [added: (8)The] charges represent acquired [removed: IPR&D] [added: in-process research and development (IPR&D)] in connection with asset acquisitions and charges recognized in connection with the impairment of IPR&D assets. [removed: |]

[removed: | (7) | The] [added: (7)The] net [removed: charge relates] [added: charges relate] to [removed: business exits] [added: the exit of businesses] and [removed: is] [added: are] primarily comprised of intangible asset impairments. [removed: |]

[removed: | (8) | The] [added: (11)The] net benefit relates to the impacts of U.S. tax reform, along with intercompany legal entity restructuring, and the finalization of certain income tax aspects of the Divestiture. [removed: |]

[removed: | (14) |] [added: -] The [removed: gain on the] [added: July 29, 2017] divestiture of the Patient Care, Deep Vein Thrombosis, and Nutritional Insufficiency businesses. [removed: |]

The table below illustrates net sales by segment and division for fiscal years [removed: 2019, 2018,] [added: 2020] and [removed: 2017:][added: 2019:]

| (in millions) | [added: | | 2020 | | | | | |] 2019 | | | | [removed: 2018] | | | | [removed: 2017] | | | | [removed: 2019] [added: 2020] | | | [removed: 2018] | | [added: | | | | | | | | | |]

| Cardiac Rhythm & Heart Failure | [added: | |] $ | [removed: 5,849] [added: 5,141] | | | [added: | |] $ | [removed: 5,947] [added: 5,849] | | | [removed: $] | [removed: 5,649] | | | [removed: (2] | [removed: )%] | | [removed: 5] | [added: (12) | |] % | [added: | | | | | | | | | | | |]

| Coronary & Structural Heart | [added: | | 3,541 | | | | | |] 3,730 | | | | [removed: 3,562] | | | | [removed: 3,113] | | | | [removed: 5] [added: (5)] | | | [removed: 14] | | [added: | | | | | | | | | |]

| Aortic, Peripheral & Venous | [added: | | 1,786 | | | | | |] 1,926 | | | | [removed: 1,845] | | | | [removed: 1,736] | | | | [removed: 4] [added: (7)] | | | [removed: 6] | | [added: | | | | | | | | | |]

| Cardiac and Vascular Group | [added: | | 10,468 | | | | | |] 11,505 | | | | [removed: 11,354] | | | | [removed: 10,498] | | | | [removed: 1] [added: (9)] | | | [removed: 8] | | [added: | | | | | | | | | |]

| Surgical Innovations | [added: | | 5,513 | | | | | |] 5,753 | | | | [removed: 5,537] | | | | [removed: 5,145] | | | | [removed: 4] [added: (4)] | | | [removed: 8] | | [added: | | | | | | | | | |]

| Respiratory, Gastrointestinal, & Renal | [added: | | 2,839 | | | | | |] 2,725 | | | | [removed: 3,179] | | | | [removed: 4,774] | | | | [removed: (14] [added: 4] | [removed: )] | | [removed: (33] | [removed: )] | [added: | | | | | | | | | |]

The global healthcare system is facing an unprecedented challenge as a result of the Covid-19 pandemic ("COVID-19" or the "pandemic").

The Company’s top priority during this pandemic has been to ensure the health and well-being of our more than 90,000 employees and their families around the globe.

In addition, the Company is focused on fulfilling our mission and getting our products and therapies to those who need them by rapidly expanding the production and distribution of critical products in the fight against COVID-19, including dramatically increased ventilator production and partnering with key government authorities to allocate our ventilators to the communities that need them most.

In fiscal year 2020, sales of Airway and Ventilator products represented approximately ten percent of the Minimally Invasive Therapies Group's net sales.

Medtronic has been supporting our communities during this time of need by, among other things, providing direct support in the form of donations of certain products, and we made an $80 million contribution to the Medtronic Foundation during fiscal year 2020, which has provided direct financial assistance to communities around the world.

COVID-19 is having, and will likely continue to have, an adverse impact on significant aspects of our Company and business, including the demand for our products, our operations, supply chains and distribution systems, and our ability to research and develop and bring to market new products and services.

Almost all of our businesses have been affected by a decline in procedure volumes as a result of COVID-19 as hospital resources have been diverted to fight the pandemic, and many government agencies in conjunction with healthcare systems have made decisions to postpone many deferrable and semi-deferrable procedures that use our products.

In addition, some people are avoiding seeking treatment for non-COVID-19 emergency procedures, resulting in an impact to those emergent product lines.

It is not possible to accurately predict the timing of a broad resumption of deferrable medical procedures and, to the extent individuals and hospital systems continue to de-prioritize, delay or cancel these procedures, our business, cash flows, financial condition and results of operations would continue to be negatively affected.

Further, COVID-19 is straining hospital systems around the world, resulting in adverse financial impacts to those systems which has resulted in and may continue to result in reduced future expenditures for capital equipment and other products and services we provide.

The Company has experienced recent changes in customer buying patterns as customers have prioritized preservation of cash and reduced their holdings of certain purchased product inventories, especially in more deferrable procedure categories.

As COVID-19 continues to impact hospital systems and other customers, we may encounter higher inventory levels which could result in inventory obsolescence due to excess and/or expired inventory.

Additionally, the pandemic's impact on our customers may adversely impact the collectability of our current and future accounts receivable balance.

COVID-19 has also disrupted and may continue to disrupt our product launches for our recently approved products and may negatively impact the regulatory approval of new products.

Clinical trials generally have suspended enrollment due to facility closures and governmental restrictions, which we expect will delay the results from those clinical trials and will impact our ability to timely bring new products to market.

In addition, a significant number of our global suppliers, vendors, and distributors have been adversely affected by COVID-19, including an adverse impact on the ability of their employees to get to their places of work and maintain the continuity of their on-site operations.

Therefore, although we work closely with our suppliers to try to ensure continuity of supply while maintaining high quality and reliability, the supply of certain components, raw materials, and services has been and may continue to be interrupted, in certain instances, as a direct result of COVID-19.

As of the June 19, 2020 filing date of this Annual Report on Form 10-K, which is in the middle of our first quarter of fiscal year 2021, we are starting to see signs of medical procedure recovery in certain geographies and across certain therapies.

We expect medical procedure recovery rates to vary by therapy and country, and to be impacted by COVID-19 case volumes, hospital and clinical occupancy and staffing levels, patient’s willingness to re-book previously deferred procedures, travel restrictions, transportation limitations, quarantine restrictions, and potential COVID-19 resurgence.

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| GAAP | | | $ | 4,055 | | | | | $ | (751) | | | | | $ | 4,789 | | | | | $ | 3.54 | | | | | (18.5) | | % | | | | | | | | | | | | | | | | | | | | | | | | |

| Restructuring and associated costs (2) | | | 441 | | | | | | 69 | | | | | | 372 | | | | | | 0.28 | | | | | | 15.6 | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Acquisition-related items (3) | | | 66 | | | | | | 13 | | | | | | 53 | | | | | | 0.04 | | | | | | 19.7 | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Certain litigation charges | | | 313 | | | | | | 59 | | | | | | 254 | | | | | | 0.19 | | | | | | 18.8 | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (Gain)/loss on minority investments (4) | | | 19 | | | | | | (3) | | | | | | 22 | | | | | | 0.02 | | | | | | (15.8) | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Debt tender premium and other charges (5) | | | 406 | | | | | | 86 | | | | | | 320 | | | | | | 0.24 | | | | | | 21.2 | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Medical device regulations (6) | | | 48 | | | | | | 6 | | | | | | 42 | | | | | | 0.03 | | | | | | 12.5 | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Exit of businesses (7) | | | 52 | | | | | | 12 | | | | | | 40 | | | | | | 0.03 | | | | | | 23.1 | | | | | | | | | | | | | | | | | | | | | | | | | | |

| IPR&D charges (8) | | | 25 | | | | | | 3 | | | | | | 22 | | | | | | 0.02 | | | | | | 12.0 | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Amortization of intangible assets | | | 1,756 | | | | | | 284 | | | | | | 1,472 | | | | | | 1.09 | | | | | | 16.2 | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Non-GAAP | | | $ | 7,261 | | | | | $ | 1,038 | | | | | $ | 6,206 | | | | | $ | 4.59 | | | | | 14.3 | | % | | | | | | | | | | | | | | | | | | | | | | | | |

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| (in millions, except per share data) | | | Income Before Income Taxes | | | | | | Income Tax (Benefit) Provision | | | | | | Net Income Attributable to Medtronic | | | | | | Diluted EPS (1) | | | | | | Effective Tax Rate | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Non-GAAP Adjustments: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

(5)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.

(6)The charges represent 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.

(9)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.

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| (in millions, except per share data) | | 2019 | | | | 2018 | | | | 2017 | | | | 2019 | | | 2018 | |

| Net income attributable to Medtronic | | $ | 4,631 | | | $ | 3,104 | | | $ | 4,028 | | | 49 | % | | (23 | )% |

| Diluted earnings per share | | $ | 3.41 | | | $ | 2.27 | | | $ | 2.89 | | | 50 | % | | (21 | )% |

The increase in net income attributable to Medtronic and diluted earnings per share (EPS) for fiscal year 2019 as compared to fiscal year 2018 was primarily attributable to the $2.4 billion tax charge recognized during fiscal year 2018 related to the enactment of U.S. comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the "Tax Act").

Further contributing to the increases was a reduction in other operating expense, net, and an increase in other non-operating income, net.

These items were partially offset by the $697 million gain on the sale of our Patient Care, Deep Vein Thrombosis, and Nutritional Insufficiency businesses within the Minimally Invasive Therapies Group on July 29, 2017 (the "Divestiture") in fiscal year 2018, along with increases in interest expense and restructuring and associated costs.

The decrease in net income attributable to Medtronic and diluted EPS for fiscal year 2018 as compared to fiscal year 2017 was unfavorably affected by the aforementioned $2.4 billion tax charge related to the Tax Act, along with the impacts of the Divestiture;

net sales of the divested businesses for fiscal years 2018 and 2017 were $0.6 billion and $2.4 billion, respectively.

For fiscal year 2018, decreases in net income attributable to Medtronic and diluted EPS were partially offset by a $697 million gain on the Divestiture.

Refer to the "Costs and Expenses" section of this Management's Discussion and Analysis for more information on the items impacting net income attributable to Medtronic and diluted EPS during fiscal years 2019, 2018, and 2017.

| GAAP | $ | 5,675 | | | $ | 2,580 | | | $ | 3,104 | | | $ | 2.27 | | | 45.5 | % |

| Restructuring and associated costs (2) | 107 | | | | 20 | | | | 87 | | | | 0.06 | | | | 18.7 | |

| Acquisition-related items (9) | 132 | | | | 42 | | | | 90 | | | | 0.07 | | | | 31.8 | |

| Debt redemption premium (10) | 38 | | | | 12 | | | | 26 | | | | 0.02 | | | | 31.6 | |

| Divestiture-related items (11) | 115 | | | | 12 | | | | 103 | | | | 0.08 | | | | 10.4 | |

| Investment loss (12) | 227 | | | | (1 | | ) | | 228 | | | | 0.17 | | | | (0.4 | ) |

| IPR&D charges (13) | 46 | | | | 5 | | | | 41 | | | | 0.03 | | | | 10.9 | |

| Gain on sale of businesses (14) | (697 | | ) | | — | | | | (697 | | ) | | (0.51 | | ) | | — | |

| Hurricane Maria (15) | 34 | | | | 1 | | | | 33 | | | | 0.02 | | | | 2.9 | |

| Amortization of intangible assets | 1,823 | | | | 322 | | | | 1,501 | | | | 1.10 | | | | 17.7 | |

| Non-GAAP | $ | 7,641 | | | $ | 1,120 | | | $ | 6,530 | | | $ | 4.77 | | | 14.7 | % |

| | Fiscal year ended April 28, 2017 | | | | | | | | | | | | | | | | | |

| GAAP | $ | 4,602 | | | $ | 578 | | | $ | 4,028 | | | $ | 2.89 | | | 12.6 | % |

| Restructuring charges, net | 373 | | | | 101 | | | | 272 | | | | 0.20 | | | | 27.1 | |

| Acquisition-related items (9) | 230 | | | | 74 | | | | 156 | | | | 0.11 | | | | 32.2 | |

| Certain litigation charges | 300 | | | | 110 | | | | 190 | | | | 0.14 | | | | 36.7 | |

| Contribution to Medtronic Foundation | 100 | | | | 37 | | | | 63 | | | | 0.05 | | | | 37.0 | |

| Impact of inventory step-up (17) | 38 | | | | 14 | | | | 24 | | | | 0.02 | | | | 36.8 | |

| Amortization of intangible assets | 1,980 | | | | 520 | | | | 1,460 | | | | 1.05 | | | | 26.3 | |

| Certain tax adjustments, net (18) | — | | | | (202) | | | | 202 | | | | 0.15 | | | | — | |

| Non-GAAP | $ | 7,623 | | | $ | 1,232 | | | $ | 6,395 | | | $ | 4.60 | | | 16.2 | % |

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| --- | --- |

| (9) | The charges primarily include integration-related costs incurred in connection with the Covidien acquisition and changes in the fair value of contingent consideration. |

| (10) | The charge, included within *interest expense* in our consolidated statements of income, was recognized in connection with the early redemption of approximately $1.2 billion of Medtronic Inc. senior notes. |

| (11) | The transaction expenses incurred in connection with the Divestiture. |

| (12) | The charge was recognized in connection with the impairment of certain cost and equity method investments. |

| (13) | The charge was recognized in connection with the impairment of IPR&D assets. |

The primary currencies of our derivative instruments are the Euro, Japanese Yen, [added: Chinese Yuan,] and [removed: British Pound.][added: others.]

The gross notional amount of all currency exchange rate derivative instruments outstanding at April [removed: 26, 2019] [added: 24, 2020] and April [removed: 27, 2018] [added: 26, 2019] was [removed: $11.1] [added: $11.9] billion and [removed: $11.5] [added: $11.1] billion, respectively.

At April [removed: 26, 2019,] [added: 24, 2020,] these contracts were in a net unrealized gain position of [removed: $322] [added: $384] million.

A sensitivity analysis of changes in the fair value of all currency exchange rate derivative contracts at April [added: 24, 2020 and April] 26, 2019 indicates that, if the U.S. dollar uniformly strengthened/weakened by 10 percent against all currencies, [added: it would have] the [added: following impact on the] fair value of these [removed: contracts would increase/decrease by approximately $916 million.][added: contracts:]

The change did not have a material impact on our results for fiscal year [removed: 2019.][added: ended 2020.]

Our debt portfolio at April [removed: 26, 2019] [added: 24, 2020] 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 [removed: securities, fixed-to-floating interest rate swap agreements, and forward starting interest rate swap agreements.][added: securities.]

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 [added: 24, 2020 and April] 26, 2019, [removed: indicates that] [added: would have] the [added: following impact on the] fair value of these [removed: instruments would correspondingly change by $49 million.][added: instruments:]

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| | | | | | | Increase (decrease) | | | | | | | | | | | | | | |

| (in millions) | | | | | | 2020 | | | | | | 2019 | | | | | | | | |

| 10% appreciation in the U.S. dollar | | | | | | $ | 750 | | | | | $ | 916 | | | | | | | |

| 10% depreciation in the U.S. dollar | | | | | | (750) | | | | | | (916) | | | | | | | | |

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| | | | | | | Increase (decrease) | | | | | | | | | | | | | | |

| (in millions) | | | | | | 2020 | | | | | | 2019 | | | | | | | | |

| 10 basis point increase in interest rates | | | | | | $ | 34 | | | | | $ | 49 | | | | | | | |

| 10 basis point decrease in interest rates | | | | | | (34) | | | | | | (49) | | | | | | | | |

With innovation and market leadership, we have pioneered advances in medical [removed: technology in all of our businesses.][added: technology.]

[removed: | • |] [added: -] Therapy Innovation: Delivering a strong launch cadence of meaningful therapies and procedures. [removed: |]

[removed: | • |] [added: -] Globalization: Addressing the inequity in [removed: health care] [added: healthcare] access globally, primarily in emerging markets. [removed: |]

[removed: | • |] [added: -] Economic Value: Becoming a leader in value-based [removed: health care] [added: healthcare] by offering new services and solutions to improve outcomes and efficiencies, lower costs by reducing hospitalizations, improve remote clinical management, and increase patient engagement. [removed: |]

Our primary customers include hospitals, clinics, third-party [removed: health care] [added: healthcare] providers, distributors, and other institutions, including governmental [removed: health care] [added: healthcare] programs and group purchasing organizations (GPOs).

On July 29, 2017, we completed the divestiture of our Patient Care, Deep Vein Thrombosis, and Nutritional Insufficiency [removed: businesses.][added: businesses (the Divestiture).]

The Cardiac and Vascular Group is made up of the Cardiac Rhythm & Heart Failure, Coronary & Structural Heart, and Aortic, Peripheral & Venous [removed: (formerly Aortic & Peripheral Vascular)] divisions.

[removed: | • |] [added: -] Implantable cardiac pacemakers including the Azure MRI SureScan, Adapta, Advisa MRI SureScan, [removed: and] Micra Transcatheter Pacing System, which is leadless and does not have a subcutaneous device pocket like a conventional [removed: pacemaker. |][added: pacemaker, and Micra AV, which can treat patients with atrioventricular block.]

[removed: | • |] [added: -] Implantable cardioverter defibrillators (ICDs), including the Visia [removed: AF and] [added: AF,] Evera MRI SureScan, and [added: the Cobalt and Chrome portfolio of BlueSync-enabled ICDs, as well as] defibrillator leads, including the Sprint Quattro Secure lead. [removed: |]

[removed: | • |] [added: -] 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 [added: Cobalt and Chrome portfolio of BlueSync-enabled CRT-Ds, as well as the] Percepta/Serena/Solara family of MRI Quad CRT-P SureScan systems. [removed: |]

[removed: | • |] [added: -] 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. [removed: |]

[removed: | • |] [added: -] Insertable cardiac monitoring systems including the Reveal LINQ, which is used to record the heart’s electrical activity before, during, and after transient symptoms such as syncope [removed: (i.e.,] [added: (i.e.] fainting) and palpitations to assist in diagnosis. [removed: |]

[removed: | • |] [added: -] 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. [removed: |]

[removed: | • |] [added: -] 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, [removed: defibrillators,] and [removed: spinal cord neurostimulators. |][added: defibrillators.]

[removed: | • |] [added: -] 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. [removed: |]

[removed: | • |] [added: -] CoreValve family of aortic valves, including the [removed: CoreValve] Evolut [removed: R] [added: R, Evolut PRO,] and [removed: CoreValve] Evolut [removed: PRO] [added: PRO+] systems for transcatheter aortic valve replacement. [removed: |]

[removed: | • |] [added: -] Percutaneous Coronary Intervention stent products including our Resolute Onyx drug-eluting stent. [removed: |]

[removed: | • |] [added: -] 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. [removed: |]

[removed: | • |] [added: -] Endovascular stent grafts and accessories including the Endurant II Stent Grant System for the treatment of abdominal aortic aneurysms, the Valiant Navion Thoracic Stent Grant System for thoracic endovascular aortic repair procedures, and the Heli-FX EndoAnchor System. [removed: |]

[removed: | • |] [added: -] Percutaneous angioplasty balloons including the IN.PACT family of drug-coated balloons, vascular stents, directional atherectomy products, and other procedure support tools. [removed: |]

[removed: | • |] [added: -] Products to treat superficial venous diseases in the lower extremities including the ClosureFast radiofrequency ablation system and the VenaSeal medical adhesive closure system. [removed: |]

[removed: | • |] [added: -] 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 [removed: Signia and iDrive powered stapling systems, the] LigaSure [removed: vessel sealing system with nano-coating,] [added: Exact Dissector] and [added: L-Hook Laparoscopic Sealer/Divider, and] the Sonicision [added: curved jaw] cordless ultrasonic dissection system. [removed: |]

[removed: | • |] [added: -] Electrosurgical hardware and instruments, including the Valleylab FT10 energy platform, and the Force TriVerse electrosurgical [removed: pencils. |][added: pencils, and surgical artificial intelligence (AI), data and analytics, and digital education and training to support robotic assisted surgery platform.]

[removed: | • |] [added: -] 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. [removed: |]

[removed: | • |] [added: -] Gastrointestinal and endoscopy products, including the PillCam [removed: COLON,] [added: portfolio,] the [added: Bravo calibration-free reflux testing systems, the EndoFLIP imaging systems, the] Emprint ablation system with Thermosphere Technology, the [removed: HET Bipolar System, the Cool-tip radiofrequency ablation system, the] Barrx platform through ablation with the Barrx 360 Express catheter, [added: the Cool-tip radiofrequency ablation system,] and the [removed: Bravo calibration-free reflux testing system. |][added: HET Bipolar System.]

[removed: | • |] [added: -] Airway, ventilation, and inhalation therapies products, including the Puritan Bennett [removed: 980 ventilator,] [added: 980, 840, and 560 ventilators,] the Newport e360 and HT70 ventilators, the TaperGuard Evac tube, Shiley Endotracheal Tubes, Shiley Tracheostomy Tubes, McGRATH MAC video laryngoscopes, and DAR Filters. [removed: |]

[removed: | • |] [added: -] Products focused on patient monitoring, including [removed: the] Capnostream [removed: 35 portable respiratory monitor with Microstream technology, the] [added: capnography monitors,] Nellcor [removed: Bedside SpO2 patient monitoring system, the] [added: pulse oximetry monitors,] INVOS cerebral/somatic oximetry systems, [removed: the] [added: and] Bispectral Index (BIS) brain monitoring [removed: technology, and the INVOS Cerebral/Somatic Oximeter. |][added: technology.]

[removed: | • |] [added: -] Products providing solutions for the treatment of renal disease, including Palindrome, Mahurkar and Mahurkar Elite Dialysis Access Catheters for renal therapy, and other products designed for use in treatment of both acute and chronic renal failure conditions. [removed: |]

The Restorative Therapies Group is made up of the [removed: Spine,] Brain Therapies, [added: Spine,] Specialty Therapies, and Pain Therapies divisions.

[removed: | • |] [added: -] Products to treat a variety of conditions affecting the spine, including degenerative disc disease, spinal deformity, spinal tumors, fractures of the spine, and stenosis. [removed: These products include our CD HORIZON LEGACY and ELEVATE systems, and the CAPSTONE, CLYDESDALE, and ELEVATE interbody spacers. |]

[removed: | • |] [added: -] Products that facilitate less invasive thoracolumbar surgeries, including the CD HORIZON SOLERA VOYAGER and LONGITUDE Percutaneous Fixation Systems. [removed: |]

[removed: | • |] [added: -] Products to treat conditions in the cervical region of the spine, including the ZEVO [removed: and ATLANTIS VISION ELITE] Anterior Cervical Plate [removed: Systems, the VERTEX SELECT Reconstruction] System, the INFINITY OCT System, and PRESTIGE LP Cervical Artificial Discs. [removed: |]

[removed: | • |] [added: -] 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. [removed: |]

[removed: | • |] [added: -] Demineralized Bone Matrix products, including MagniFuse, GRAFTON/GRAFTON PLUS, [added: COREX,] and PROGENIX, and the MASTERGRAFT family of synthetic bone graft products - Matrix, Putty, and Granules. [removed: |]

[removed: | • | 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 revascularization devices for treatment of acute ischemic stroke, the Riptide Aspiration System and a portfolio of associated access catheters [added: including our React aspiration catheters] also for the treatment of acute ischemic stroke. [removed: |]

[removed: | • |] [added: -] 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 Humanitarian Device Exemption (HDE) in the U.S.), and chronic, intractable primary dystonia (approved under a HDE in the U.S.). [removed: 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). |]

[removed: | • |] [added: -] Pelvic health and gastric therapies products, including [removed: InterStim, a neurostimulator,] [added: 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. [removed: Our NURO System delivers Percutaneous Tibial Neuromodulation therapy to treat overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. Our Enterra gastric neurostimulator is approved as a humanitarian device and is used for the treatment of chronic, intractable nausea and vomiting due to gastroparesis. |]

[removed: | • |] [added: -] ENT products, including the Straightshot M5 Microdebrider Handpiece, the IPC system, NIM Nerve Monitoring Systems, [added: FUSION Compact and StealthStation] ENT Navigation System, as well as products for hearing restoration and obstructive sleep apnea. [removed: |]

[removed: | • | Transformative solutions products, including our PEAK Surgery System and Aquamantys System.] Our [removed: 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 [removed: System uses] [added: Sealers use] patented transcollation technology to provide haemostatic sealing of soft tissue and bone and [removed: is] [added: are] cleared for use in a variety of surgical procedures, including orthopedic surgery, spine, solid organ resection and thoracic procedures. [removed: |]

[removed: | • |] [added: -] 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. [removed: This includes the Intellis Spinal Cord Stimulation System, with AdaptiveStim and SureScan MRI Technology, the Evolve workflow algorithm, and Snapshot reporting. Products also include our RestoreSensor (rechargeable) SureScan MRI, with its proprietary AdaptiveStim technology. |]





- 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.

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, which received CE Mark approval in January of 2020.

- 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 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 and Aquamantys Sealers are advanced energy products.

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.

These products include our CD HORIZON SOLERA system, T2 Strastosphere, and the CLYDESDALE, and ELEVATE interbody spacers.

These products also include titanium interbody implants and surface technologies from Titan Spine, acquired in June of 2019.

Our NURO System delivers Percutaneous Tibial Neuromodulation therapy to treat overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

Our Enterra gastric neurostimulator is approved as a humanitarian device and is used for the treatment of chronic, intractable nausea and vomiting due to gastroparesis.

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.


- Insulin pumps, including the MiniMed 670G system, which is the world's first hybrid closed loop system.

COVID-19 Pandemic

The global COVID-19 pandemic, together with the preventative and precautionary measures taken by businesses, communities and governments, is impacting, and we expect will 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.

Hospitals, which purchase our technology, are also seeking to reduce

distribution and post-marketing surveillance of our products.

The regulation initially provided a three-year implementation period to May 2020, but that timeline has been delayed to May 2021 due to COVID-19 and its impact on audits and technical file review by Notified Bodies.

FDA completed its Warning Letter reinspection at the TYRX facility in Minneapolis, since the manufacturing operations at Monmouth Junction have ceased.

The inspection concluded in March 2020 with zero observations, and in April 2020 the Warning Letter was lifted by FDA.

In August 2018, we received two FDA Warning Letters, one

Reinspection was completed at Juncos in November 2019 and resulted in four 483 observations.

Reinspection was completed at Mounds View in January 2020 and resulted in zero 483 observations.

Both the Juncos and Mounds View Warning Letters were lifted in February 2020.

with increasingly strict enforcement regimes.

OVERVIEW

| | |

| --- | --- |

| • | Neurosurgery products, including platform technologies and implant therapies. Our StealthStation S8 Navigation System and O-arm Imaging System are both platforms used in cranial, spinal, sinus, and orthopedic procedures. Our Midas Rex Surgical Drills are used in cranial, spinal, ENT, and orthopedic procedures. Our 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 Mazor X robotic guidance systems are used in robot-assisted spine procedures and combine the best-in-class robotics and navigation capability. |

Additionally, our Specialty Therapies division includes products in the emerging field of transformative solutions surgical incision technology, as well as the haemostatic sealing of soft tissue and bone.

| • | Therapy management software, including CareLink software for patients and for healthcare professionals, with advanced web technology to help patients and their health care providers control their diabetes and improve engagement. |

In the aggregate, these intellectual property assets and licenses are of

cash flow.

The regulation has a three-year implementation period to May 2020.

We have completed the commitments under the Form-483 and have been communicating to the U.S. FDA on the progress.

The next step will be to signal readiness for inspection, which will occur at the Medtronic Rice Creek facility in Minneapolis, now that the manufacturing operations at Monmouth Junction have ceased.

Medtronic has been working with the U.S. FDA on resolving the open items and continues to make steady progress on implementing corrective actions.

After the actions are complete, the U.S. FDA will perform a reinspection in order to lift the Warning Letters.

If we, or the third

[removed: FORM 10-K][added: FORM 10-K]

| [removed: x] [added: ☒] | [added: | |] Annual report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934. For the fiscal year ended April [removed: 26, 2019.] [added: 24, 2020.] | [added: | |]

| [removed: o] [added: ☐] | [added: | |] Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of [removed: 1934. For] [added: 1934. For] the transition period from __________ to __________ | [added: | |]

[removed: ®][added: ®]

| Ireland | | [added: | | | |] 98-1183488 | [added: | |]

| [removed: (Jurisdiction] [added: (State or other jurisdiction] of [removed: incorporation)] [added: incorporation or organization)] | | [added: | | | |] (I.R.S. Employer Identification No.) | [added: | |]

(Address of principal executive [removed: office)][added: offices)]

(Registrant's telephone [removed: number)][added: number, including area code)]

| Title of each class | [added: | |] Trading [removed: Symbol] [added: Symbol(s)] | [added: | |] Name of each exchange on which registered | [added: | |]

| Ordinary shares, par value $0.0001 per share | [added: | |] MDT | [added: | |] New York Stock [removed: Exchange, Inc.] [added: Exchange] | [added: | |]

| Floating Rate Notes due 2021 | [added: | |] MDT/21 | [added: | |] New York Stock [removed: Exchange, Inc.] [added: Exchange] | [added: | |]

| 0.000% [added: Senior] Notes due 2021 | [added: | |] MDT/21A | [added: | |] New York Stock [removed: Exchange, Inc.] [added: Exchange] | [added: | |]

| 0.375% [added: Senior] Notes due 2023 | [added: | |] MDT/23B | [added: | |] New York Stock [removed: Exchange, Inc.] [added: Exchange] | [added: | |]

| 1.125% [added: Senior] Notes due 2027 | [added: | |] MDT/27 | [added: | |] New York Stock [removed: Exchange, Inc.] [added: Exchange] | [added: | |]

| 1.625% [added: Senior] Notes due 2031 | [added: | |] MDT/31 | [added: | |] New York Stock [removed: Exchange, Inc.] [added: Exchange] | [added: | |]

| 2.250% [added: Senior] Notes due 2039 | [added: | |] MDT/39A | [added: | |] New York Stock [removed: Exchange, Inc.] [added: Exchange] | [added: | |]

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities [removed: Act. Yes x No o][added: Act.]

Yes [removed: o] [added: ☒] No [removed: x][added: ☐]

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 [removed: days. Yes x No o][added: days.]

Yes [removed: x] [added: ☐] No [removed: o][added: ☒]

Large accelerated filer [removed: x] [added: ☒] Accelerated filer [removed: o] [added: ☐] Non-accelerated filer [removed: o] [added: ☐] Smaller reporting company [removed: o] [added: ☐] Emerging growth company [removed: o][added: ☐]

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. [removed: o][added: ☐]

Aggregate market value of voting and non-voting common equity of Medtronic plc held by non-affiliates of the registrant as of October [removed: 26, 2018,] [added: 25, 2019,] based on the closing price of [removed: $89.75] [added: $105.44] as reported on the New York Stock Exchange: [removed: approximately $120.8 billion.][added: approximately $141.3 billion.]

Number of Ordinary Shares outstanding on June [removed: 18, 2019: 1,341,156,703][added: 17, 2020: 1,341,298,882]

Portions of the registrant’s Proxy Statement for [removed: its 2019 Annual] [added: its 2020 Annual] General Meeting are incorporated by reference into Part III hereof.

| Item | | [added: | | | |] Description | | [added: | | | |] Page | [added: | |]

| [removed: [1A.](#s6783F36ED1E7536E91A7D9A09F472ECC)] [added: [1A.](#iee3171f35a7c45a1b39695c002cea866_19)] | | [added: | | | |] [Risk [removed: Factors](#s6783F36ED1E7536E91A7D9A09F472ECC)] [added: Factors](#iee3171f35a7c45a1b39695c002cea866_19)] | | [removed: [12](#s6783F36ED1E7536E91A7D9A09F472ECC)] | [added: | | | [14](#iee3171f35a7c45a1b39695c002cea866_19) | | |]

| [removed: [1B.](#sA2388C3B777F58EA8CD44B70E3D86B62)] [added: [1B.](#iee3171f35a7c45a1b39695c002cea866_22)] | | [added: | | | |] [Unresolved Staff [removed: Comments](#sA2388C3B777F58EA8CD44B70E3D86B62)] [added: Comments](#iee3171f35a7c45a1b39695c002cea866_22)] | | [removed: [23](#sA2388C3B777F58EA8CD44B70E3D86B62)] | [added: | | | [26](#iee3171f35a7c45a1b39695c002cea866_22) | | |]

| [removed: [3.](#s7E3F298287CA50109F333306EF7B0C37)] [added: [3.](#iee3171f35a7c45a1b39695c002cea866_28)] | | [added: | | | |] [Legal [removed: Proceedings](#s7E3F298287CA50109F333306EF7B0C37)] [added: Proceedings](#iee3171f35a7c45a1b39695c002cea866_28)] | | [removed: [24](#s7E3F298287CA50109F333306EF7B0C37)] | [added: | | | [27](#iee3171f35a7c45a1b39695c002cea866_28) | | |]

| [removed: [4.](#s070E8309DA8B59FE97C6EF44843F1EA5)] [added: [4.](#iee3171f35a7c45a1b39695c002cea866_31)] | | [added: | | | |] [Mine Safety [removed: Disclosures](#s070E8309DA8B59FE97C6EF44843F1EA5)] [added: Disclosures](#iee3171f35a7c45a1b39695c002cea866_31)] | | [removed: [24](#s070E8309DA8B59FE97C6EF44843F1EA5)] | [added: | | | [27](#iee3171f35a7c45a1b39695c002cea866_31) | | |]

| [removed: [5.](#sADB145703D0A55CB8848BB531CE5DE41)] [added: [5.](#iee3171f35a7c45a1b39695c002cea866_37)] | | [added: | | | |] [Market for Medtronic’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity [removed: Securities](#sADB145703D0A55CB8848BB531CE5DE41)] [added: Securities](#iee3171f35a7c45a1b39695c002cea866_37)] | | [removed: [25](#sADB145703D0A55CB8848BB531CE5DE41)] | [added: | | | [28](#iee3171f35a7c45a1b39695c002cea866_37) | | |]

| [removed: [6.](#sC8D94E3A4F72588F92F7324B8DA4E181)] [added: [6.](#iee3171f35a7c45a1b39695c002cea866_40)] | | [added: | | | |] [Selected Financial [removed: Data](#sC8D94E3A4F72588F92F7324B8DA4E181)] [added: Data](#iee3171f35a7c45a1b39695c002cea866_40)] | | [removed: [28](#sC8D94E3A4F72588F92F7324B8DA4E181)] | [added: | | | [31](#iee3171f35a7c45a1b39695c002cea866_40) | | |]

| [removed: [7.](#s667784DF448952079F6CCF5521D93467)] [added: [7.](#iee3171f35a7c45a1b39695c002cea866_43)] | | [added: | | | |] [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#s667784DF448952079F6CCF5521D93467)] [added: Operations](#iee3171f35a7c45a1b39695c002cea866_43)] | | [removed: [29](#s667784DF448952079F6CCF5521D93467)] | [added: | | | [32](#iee3171f35a7c45a1b39695c002cea866_43) | | |]

| [removed: [7A.](#sAEE0F5FD901B52F8A16D822DFFC59415)] [added: [7A.](#iee3171f35a7c45a1b39695c002cea866_112)] | | [added: | | | |] [Quantitative and Qualitative Disclosures About Market [removed: Risk](#sAEE0F5FD901B52F8A16D822DFFC59415)] [added: Risk](#iee3171f35a7c45a1b39695c002cea866_112)] | | [removed: [52](#sAEE0F5FD901B52F8A16D822DFFC59415)] | [added: | | | [56](#iee3171f35a7c45a1b39695c002cea866_112) | | |]

| [removed: [8.](#s07BBC7C419A45037905158AE727976A3)] [added: [8.](#iee3171f35a7c45a1b39695c002cea866_115)] | | [added: | | | |] [Financial Statements and Supplementary [removed: Data](#s07BBC7C419A45037905158AE727976A3)] [added: Data](#iee3171f35a7c45a1b39695c002cea866_115)] | | [removed: [53](#s07BBC7C419A45037905158AE727976A3)] | [added: | | | [57](#iee3171f35a7c45a1b39695c002cea866_115) | | |]

| [removed: [9.](#s7B0A20799ECA52DA91097A06EB6F9666)] [added: [9.](#iee3171f35a7c45a1b39695c002cea866_298)] | | [added: | | | |] [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#s7B0A20799ECA52DA91097A06EB6F9666)] [added: Disclosure](#iee3171f35a7c45a1b39695c002cea866_298)] | | [removed: [127](#s7B0A20799ECA52DA91097A06EB6F9666)] | [added: | | | [117](#iee3171f35a7c45a1b39695c002cea866_298) | | |]

| [removed: [9A.](#s0F1EBEC7CBC85192A68DA4E3B14AE493)] [added: [9A.](#iee3171f35a7c45a1b39695c002cea866_301)] | | [added: | | | |] [Controls and [removed: Procedures](#s0F1EBEC7CBC85192A68DA4E3B14AE493)] [added: Procedures](#iee3171f35a7c45a1b39695c002cea866_301)] | | [removed: [127](#s0F1EBEC7CBC85192A68DA4E3B14AE493)] | [added: | | | [117](#iee3171f35a7c45a1b39695c002cea866_301) | | |]

| | | [removed: [PART III](#s36615C9BA12F57CDB7163D1570A10A87)] | | | [added: | [PART III](#iee3171f35a7c45a1b39695c002cea866_307) | | | | | | | | |]

| [removed: [10.](#s3493C18427F65C82ABBD4914BA490B20)] [added: [10.](#iee3171f35a7c45a1b39695c002cea866_310)] | | [added: | | | |] [Directors, Executive Officers, and Corporate [removed: Governance](#s3493C18427F65C82ABBD4914BA490B20)] [added: Governance](#iee3171f35a7c45a1b39695c002cea866_310)] | | [removed: [128](#s3493C18427F65C82ABBD4914BA490B20)] | [added: | | | [118](#iee3171f35a7c45a1b39695c002cea866_310) | | |]

| [removed: [12.](#s19DD77BFD4A454EFBA6F530341F72AED)] [added: [12.](#iee3171f35a7c45a1b39695c002cea866_316)] | | [added: | | | |] [Security Ownership of Certain Beneficial Owners and Management and Related Shareholder [removed: Matters](#s19DD77BFD4A454EFBA6F530341F72AED)] [added: Matters](#iee3171f35a7c45a1b39695c002cea866_316)] | | [removed: [129](#s19DD77BFD4A454EFBA6F530341F72AED)] | [added: | | | [120](#iee3171f35a7c45a1b39695c002cea866_316) | | |]

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| --- | --- | --- | --- | --- | --- |

| | | | | | |

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| 0.000% Senior Notes due 2022 | | | MDT/22B | | | New York Stock Exchange | | |

| 0.25% Senior Notes due 2025 | | | MDT/25 | | | New York Stock Exchange | | |

| 1.00% Senior Notes due 2031 | | | MDT/31A | | | New York Stock Exchange | | |

| 1.50% Senior Notes due 2039 | | | MDT/39B | | | New York Stock Exchange | | |

| 1.75% Senior Notes due 2049 | | | MDT/49 | | | New York Stock Exchange | | |

Yes ☒ No ☐

Yes ☒ No ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

Yes ☒ No ☐

Yes ☐ No ☒

| | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | | | | | | | | | | | | | | |

| | | | | | | [PART I](#iee3171f35a7c45a1b39695c002cea866_13) | | | | | | | | |

| [1.](#iee3171f35a7c45a1b39695c002cea866_16) | | | | | | [Business](#iee3171f35a7c45a1b39695c002cea866_16) | | | | | | [3](#iee3171f35a7c45a1b39695c002cea866_16) | | |

| [2.](#iee3171f35a7c45a1b39695c002cea866_25) | | | | | | [Properties](#iee3171f35a7c45a1b39695c002cea866_25) | | | | | | [27](#iee3171f35a7c45a1b39695c002cea866_25) | | |

| | | | | | | [PART II](#iee3171f35a7c45a1b39695c002cea866_34) | | | | | | | | |

| [9B.](#iee3171f35a7c45a1b39695c002cea866_304) | | | | | | [Other Information](#iee3171f35a7c45a1b39695c002cea866_304) | | | | | | [117](#iee3171f35a7c45a1b39695c002cea866_304) | | |

| [11.](#iee3171f35a7c45a1b39695c002cea866_313) | | | | | | [Executive Compensation](#iee3171f35a7c45a1b39695c002cea866_313) | | | | | | [120](#iee3171f35a7c45a1b39695c002cea866_313) | | |

| | | | | | | [PART IV](#iee3171f35a7c45a1b39695c002cea866_325) | | | | | | | | |

| [16.](#iee3171f35a7c45a1b39695c002cea866_334) | | | | | | [Form 10-K Summary](#iee3171f35a7c45a1b39695c002cea866_334) | | | | | | [128](#iee3171f35a7c45a1b39695c002cea866_334) | | |

| | | | | | | [Signatures](#iee3171f35a7c45a1b39695c002cea866_337) | | | | | | [129](#iee3171f35a7c45a1b39695c002cea866_337) | | |

- the COVID-19 pandemic and the actions of businesses, communities and governments in response;

| | |

| --- | --- |

| | | |

| --- | --- | --- |

| | | | | |

| --- | --- | --- | --- | --- |

| | | [PART I](#sACC11FDD5FB95750B23FDF3522E8195C) | | |

| [1.](#s3CFDA8917A7957AA98EC4DA215C8FF0F) | | [Business](#s3CFDA8917A7957AA98EC4DA215C8FF0F) | | [3](#s3CFDA8917A7957AA98EC4DA215C8FF0F) |

| [2.](#s3C8BC32C9D785632B4AF8284CA21EB00) | | [Properties](#s3C8BC32C9D785632B4AF8284CA21EB00) | | [24](#s3C8BC32C9D785632B4AF8284CA21EB00) |

| | | [PART II](#sCD22BB6010C65EAD997909103CD82A17) | | |

| [9B.](#s592DF6C231585F6894C7AC965CF5C878) | | [Other Information](#s592DF6C231585F6894C7AC965CF5C878) | | [127](#s592DF6C231585F6894C7AC965CF5C878) |

| [11.](#sE354AC72CE2653C0A78915447BCCE888) | | [Executive Compensation](#sE354AC72CE2653C0A78915447BCCE888) | | [129](#sE354AC72CE2653C0A78915447BCCE888) |

| | | [PART IV](#s5938A12959395193ABCCBF7BD9A9AB4C) | | |

| [16.](#s1E323F09223755B3AC3F9C53497E5F54) | | [Form 10-K Summary](#s1E323F09223755B3AC3F9C53497E5F54) | | [137](#s1E323F09223755B3AC3F9C53497E5F54) |

| | | [Signatures](#s1B57B8D76B3957FD825E2640CE1AFE3D) | | [138](#s1B57B8D76B3957FD825E2640CE1AFE3D) |

The Company's total manufacturing and research space is approximately [removed: 9] [added: 9.4] million square feet.

Approximately [removed: 43] [added: 37] percent of the manufacturing or research facilities are owned by Medtronic and the balance is leased.

| Location Country or State | | [added: | | | |] Square Feet (in thousands) | | [added: |]

| Connecticut | | [added: | | | |] 1,138 | | [added: |]

| Puerto Rico | | [added: | | | |] 831 | | [added: |]

| Mexico | | [added: | | | |] 762 | | [added: |]

| Italy | | [added: | | | |] 454 | | [added: |]

| Ireland | | [added: | | | |] 446 | | [added: |]

| Arizona | | [added: | | | |] 319 | | [added: |]

| Dominican Republic | | [added: | | | |] 304 | | [added: |]

| Switzerland | | [added: | | | |] 283 | | [added: |]

Medtronic also maintains sales and administrative offices in the U.S. at 4 locations in 4 states and outside the U.S. at [removed: 161] [added: 145] locations in [removed: 66] [added: 64] countries.

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Minnesota | | | | | | 985 | | |

| China | | | | | | 823 | | |

| California | | | | | | 410 | | |

| Colorado | | | | | | 320 | | |

| Israel | | | | | | 297 | | |

| India | | | | | | 254 | | |

| Massachusetts | | | | | | 217 | | |

| | | | |

| --- | --- | --- | --- |

| Minnesota | | 984 | |

| China | | 843 | |

| Texas | | 431 | |

| California | | 389 | |

| Colorado | | 336 | |

| Massachusetts | | 255 | |

| Israel | | 204 | |

The following table provides information about the shares repurchased by the Company during the fourth quarter of fiscal year [removed: 2019:][added: 2020:]

| Fiscal Period | | [added: | | | |] Total Number [removed: of Shares] [added: of Shares] Purchased | | | [added: | | |] Average [removed: Price Paid] [added: Price Paid] per Share | | | | [added: | |] Total Number of [removed: Shares Purchased] [added: Shares Purchased] as a Part [removed: of Publicly Announced Program] [added: of Publicly Announced Program] | | | [added: | | |] Maximum Approximate Dollar Value of Shares that may yet be Purchased Under the Program | | |

On June [removed: 18, 2019,] [added: 17, 2020,] there were approximately [removed: 25,797] [added: 24,933] shareholders of record of the Company’s ordinary shares.

Ordinary cash dividends declared and paid totaled [removed: 50.0] [added: 54.0] cents per share for each quarter of fiscal year [removed: 2019] [added: 2020] and [removed: 46.0] [added: 50.0] cents per share for each quarter of fiscal year [removed: 2018.][added: 2019.]

The graph assumes that $100 was invested at market close on April [removed: 25, 2014] [added: 24, 2015] 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.

[removed: ][added: ]

| Company/Index | | [removed: April 2014] | | | | April 2015 | | | | [added: | |] April 2016 | | | | [added: | |] April 2017 | | | | [added: | |] April 2018 | | | | [added: | |] April 2019 | | | [added: | | | April 2020 | | |]

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, Egypt, [removed: Eritrea,] Iran, Iraq, Ivory Coast, Lebanon, Liberia, Libya, Republic of Guinea, Somalia, Sudan, Syria, Tunisia, Ukraine and Zimbabwe.

Dividends paid by Medtronic will generally be subject to Irish dividend withholding tax [added: (currently] at [removed: the standard] [added: a] rate of [removed: income tax (currently 20] [added: 25] percent) unless an exemption applies.

[removed: | • |] [added: -] 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 [removed: |]

[removed: | • |] [added: -] 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. [removed: |]

| | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| 1/25/2020-2/21/2020 | | | | | | 950,308 | | | | | | $ | 118.23 | | | | | 950,308 | | | | | | $ | 5,950,169,124 | |

| 2/22/2020-3/27/2020 | | | | | | — | | | | | | — | | | | | | — | | | | | | 5,950,169,124 | | |

| 3/28/2020-4/24/2020 | | | | | | — | | | | | | — | | | | | | — | | | | | | 5,950,169,124 | | |

| Total | | | | | | 950,308 | | | | | | $ | 118.23 | | | | | 950,308 | | | | | | 5,950,169,124 | | |

The Company has deprioritized repurchases of ordinary shares as a result of the COVID-19 pandemic.

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Medtronic plc | | | | | | $ | 100.00 | | | | | $ | 104.10 | | | | | $ | 111.62 | | | | | $ | 111.69 | | | | | $ | 122.69 | | | | | $ | 142.51 | |

| S&P 500 Index | | | | | | 100.00 | | | | | | 99.69 | | | | | | 117.55 | | | | | | 134.24 | | | | | | 150.80 | | | | | | 148.44 | | |

| S&P 500 Health Care Equipment Index | | | | | | 100.00 | | | | | | 105.96 | | | | | | 124.14 | | | | | | 149.40 | | | | | | 175.35 | | | | | | 199.55 | | |

| | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| 1/26/2019-2/22/2019 | | — | | | $ | — | | | — | | | $ | 1,323,491,730 | |

| 2/23/2019-3/29/2019 | | 1,581,836 | | | 91.67 | | | | 1,581,836 | | | 7,178,491,789 | | |

| 3/30/2019-4/26/2019 | | — | | | — | | | | — | | | 7,178,491,789 | | |

| Total | | 1,581,836 | | | $ | 91.67 | | | 1,581,836 | | | $ | 7,178,491,789 | |

This authorization replaced the previous June 2015 repurchase authorization to redeem up to an aggregate number of ordinary shares.

| | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Medtronic, Inc./ Medtronic plc | | $ | 100.00 | | | $ | 135.72 | | | $ | 141.29 | | | $ | 151.50 | | | $ | 151.59 | | | $ | 166.52 | |

| S&P 500 Index | | 100.00 | | | | 115.98 | | | | 115.62 | | | | 136.33 | | | | 155.69 | | | | 174.89 | | |

| S&P 500 Health Care Equipment Index | | 100.00 | | | | 131.70 | | | | 139.55 | | | | 163.50 | | | | 196.77 | | | | 230.93 | | |

| | |

| --- | --- |

Fiscal years [removed: 2019, 2018, 2017, and 2015] [added: 2017 through 2020] were 52-week years.

Fiscal year 2016 was a 53-week year, [added: as will be fiscal year 2021,] with the additional week occurring in the first quarter.

The table below illustrates operating results and other selected financial data for fiscal years [removed: 2015] [added: 2016] to [removed: 2019.][added: 2020.]

| | [added: | |] Fiscal Year | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| (in millions, except per share data and additional information) | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [added: | |] 2017 | | | | [added: | |] 2016 | | | | [removed: 2015(1)] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Operating Results: | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| Net sales | [added: | |] $ | [added: 28,913 | | | | | $ |] 30,557 | | | [added: | |] $ | 29,953 | | | [added: | |] $ | 29,710 | | | [added: | |] $ | 28,833 | | | [removed: $] | [removed: 20,261] | | [added: | | | | | | | | | | | | | | | | | | | |]

| Cost of products sold | [added: | | 9,424 | | | | | |] 9,155 | | | | [added: | |] 9,067 | | | | [added: | |] 9,294 | | | | [added: | |] 9,128 | | | | [removed: 6,306] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Research and development expense | [added: | | 2,331 | | | | | |] 2,330 | | | | [added: | |] 2,256 | | | | [added: | |] 2,193 | | | | [added: | |] 2,211 | | | | [removed: 1,638] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Selling, general, and administrative expense | [added: | | 10,109 | | | | | |] 10,418 | | | | [added: | |] 10,238 | | | | [added: | |] 10,018 | | | | [added: | |] 9,770 | | | | [removed: 7,446] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Amortization of intangible assets | [added: | | 1,756 | | | | | |] 1,764 | | | | [added: | |] 1,823 | | | | [added: | |] 1,980 | | | | [added: | |] 1,931 | | | | [removed: 733] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Restructuring charges, net | [added: | | 118 | | | | | |] 198 | | | | [added: | |] 30 | | | | [added: | |] 303 | | | | [added: | |] 290 | | | | [removed: 237] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Certain litigation charges | [added: | | 313 | | | | | |] 166 | | | | [added: | |] 61 | | | | [added: | |] 300 | | | | [added: | |] 26 | | | | [removed: 42] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Gain on sale of businesses | [removed: —] | | [added: —] | | [removed: (697] | | [removed: )] | | — | | | | [added: | | (697) | | | | | |] — | | | | [added: | |] — | | | [added: | | | | | | | | | | | | | | | | | | | | | | | |]

| Other operating expense, net | [added: | | 71 | | | | | |] 258 | | | | [added: | |] 535 | | | | [added: | |] 239 | | | | [added: | |] 93 | | | | [removed: 182] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| [removed: Operating profit] [added: Operating profit] | [added: | | 4,791 | | | | | |] 6,268 | | | | [added: | |] 6,640 | | | | [added: | |] 5,383 | | | | [added: | |] 5,384 | | | | [removed: 3,677] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Other non-operating income, net | [removed: (373] | | [removed: )] [added: (356)] | | [removed: (181] | | [removed: )] | | [removed: (313] [added: (373)] | | [removed: )] | | [removed: (338] | | [removed: )] [added: (181)] | | [removed: (475] | | [removed: )] | [added: | (313) | | | | | | (338) | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| Interest expense | [added: | | 1,092 | | | | | |] 1,444 | | | | [added: | |] 1,146 | | | | [added: | |] 1,094 | | | | [added: | |] 1,386 | | | | [removed: 666] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Income before income taxes | [added: | | 4,055 | | | | | |] 5,197 | | | | [added: | |] 5,675 | | | | [added: | |] 4,602 | | | | [added: | |] 4,336 | | | | [removed: 3,486] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Income tax [added: (benefit)] provision | [added: | | (751) | | | | | |] 547 | | | | [added: | |] 2,580 | | | | [added: | |] 578 | | | | [added: | |] 798 | | | | [removed: 811] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Net income | [added: | | 4,806 | | | | | |] 4,650 | | | | [added: | |] 3,095 | | | | [added: | |] 4,024 | | | | [added: | |] 3,538 | | | | [removed: 2,675] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Net (income) loss attributable to noncontrolling interests | [removed: (19] | | [removed: )] [added: (17)] | | [added: | | | | (19) | | | | | |] 9 | | | | [added: | |] 4 | | | | [added: | |] — | | | | [removed: —] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Net income attributable to Medtronic | [added: | |] $ | [added: 4,789 | | | | | $ |] 4,631 | | | [added: | |] $ | 3,104 | | | [added: | |] $ | 4,028 | | | [added: | |] $ | 3,538 | | | [removed: $] | [removed: 2,675] | | [added: | | | | | | | | | | | | | | | | | | | |]

| Basic earnings per share | [added: | |] $ | [added: 3.57 | | | | | $ |] 3.44 | | | [added: | |] $ | 2.29 | | | [added: | |] $ | 2.92 | | | [added: | |] $ | 2.51 | | | [removed: $] | [removed: 2.44] | | [added: | | | | | | | | | | | | | | | | | | | |]

| Diluted earnings per share | [added: | | 3.54 | | | | | |] 3.41 | | | | [added: | |] 2.27 | | | | [added: | |] 2.89 | | | | [added: | |] 2.48 | | | | [removed: 2.41] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Cash dividends declared per ordinary share | [added: | | 2.16 | | | | | |] 2.00 | | | | [added: | |] 1.84 | | | | [added: | |] 1.72 | | | | [added: | |] 1.52 | | | | [removed: 1.22] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Financial Position at Fiscal Year-end: | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| Total assets | [added: | | 90,689 | | | | | |] 89,694 | | | | [added: | |] 91,393 | | | | [added: | |] 99,857 | | | | [added: | |] 99,685 | | | | [removed: 106,726] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Long-term debt | [added: | | 22,021 | | | | | |] 24,486 | | | | [added: | |] 23,699 | | | | [added: | |] 25,921 | | | | [added: | |] 30,109 | | | | [removed: 33,752] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Shareholders’ equity | [added: | | 50,737 | | | | | |] 50,091 | | | | [added: | |] 50,720 | | | | [added: | |] 50,208 | | | | [added: | |] 51,977 | | | | [removed: 53,144] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Additional Information: | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| Full-time employees at year-end | [added: | | 93,792 | | | | | |] 90,071 | | | | [added: | |] 86,368 | | | | [added: | |] 91,267 | | | | [added: | |] 88,063 | | | | [removed: 85,573] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| Full-time equivalent employees at year-end | [added: | | 104,950 | | | | | |] 101,013 | | | | [added: | |] 98,003 | | | | [added: | |] 102,688 | | | | [added: | |] 98,017 | | | | [removed: 92,500] | | | [added: | | | | | | | | | | | | | | | | | | | |]

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

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| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| | |

| --- | --- |

| (1) | Covidien plc was acquired on January 26, 2015. As such, for the fiscal year ended April 24, 2015, the results of operations of Covidien are reflected in Medtronic’s results of operations for only the fourth quarter due to the timing of the acquisition, which affects comparability. |

To the Shareholders and Board of Directors of Medtronic [removed: plc:][added: plc]

We have audited the accompanying consolidated balance sheets of Medtronic plc and its subsidiaries (the “Company”) as of April [removed: 26, 2019] [added: 24, 2020] and April [removed: 27, 2018,] [added: 26, 2019,] and the related consolidated statements of income, comprehensive income, equity and cash flows for each of the three years in the period ended April [removed: 26, 2019,] [added: 24, 2020,] including the related notes and schedule of valuation and qualifying accounts for each of the three years in the period ended April [removed: 26, 2019] [added: 24, 2020] 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 [removed: 26, 2019,] [added: 24, 2020,] 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 [removed: 26, 2019] [added: 24, 2020] and April [removed: 27, 2018,] [added: 26, 2019,] and the results of its operations and its cash flows for each of the three years in the period ended April [removed: 26, 2019] [added: 24, 2020] 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 [removed: 26, 2019,] [added: 24, 2020,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

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 [removed: Management’s] [added: Management's] Annual Report on Internal Control [removed: over] [added: Over] Financial Reporting appearing under Item [removed: 9A .][added: 9A.]

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 [removed: accordance with generally accepted accounting principles.]

| /s/ PricewaterhouseCoopers LLP | [added: | |]

| Minneapolis, Minnesota | [added: | |]

| | [added: | |] Fiscal Year | | | | | | | | | | | [added: | | | | | | | | | | | | | | | |]

| (in millions, except per share data) | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | | [added: | | | | | | | |]

| Net sales | [added: | |] $ | [added: 28,913 | | | | | $ |] 30,557 | | | [added: | |] $ | 29,953 | | | [removed: $] | [removed: 29,710] | | [added: | | | | | | | |]

| Costs and expenses: | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | |]

| Cost of products sold | [added: | | 9,424 | | | | | |] 9,155 | | | | [added: | |] 9,067 | | | | [removed: 9,294] | | | [added: | | | | | | | |]

| Research and development expense | [added: | | 2,331 | | | | | |] 2,330 | | | | [added: | |] 2,256 | | | | [removed: 2,193] | | | [added: | | | | | | | |]

| Selling, general, and administrative expense | [added: | | 10,109 | | | | | |] 10,418 | | | | [added: | |] 10,238 | | | | [removed: 10,018] | | | [added: | | | | | | | |]

| Amortization of intangible assets | [added: | | 1,756 | | | | | |] 1,764 | | | | [added: | |] 1,823 | | | | [removed: 1,980] | | | [added: | | | | | | | |]

| Restructuring charges, net | [added: | | 118 | | | | | |] 198 | | | | [added: | |] 30 | | | | [removed: 303] | | | [added: | | | | | | | |]

| Certain litigation charges | [added: | | 313 | | | | | |] 166 | | | | [added: | |] 61 | | | | [removed: 300] | | | [added: | | | | | | | |]

| Gain on sale of businesses | [removed: —] | | [added: —] | | [removed: (697] | | [removed: )] | | — | | | [added: | | | (697) | | | | | | | | | | | | | | |]

| Other operating expense, net | [added: | | 71 | | | | | |] 258 | | | | [added: | |] 535 | | | | [removed: 239] | | | [added: | | | | | | | |]

| Operating profit | [added: | | 4,791 | | | | | |] 6,268 | | | | [added: | |] 6,640 | | | | [removed: 5,383] | | | [added: | | | | | | | |]

| Other non-operating income, net | [removed: (373] | | [removed: )] [added: (356)] | | [removed: (181] | | [removed: )] | | [removed: (313] [added: (373)] | | [removed: )] | [added: | | | (181) | | | | | | | | | | | | | | |]

| Interest expense | [added: | | 1,092 | | | | | |] 1,444 | | | | [added: | |] 1,146 | | | | [removed: 1,094] | | | [added: | | | | | | | |]

| Income before income taxes | [added: | | 4,055 | | | | | |] 5,197 | | | | [added: | |] 5,675 | | | | [removed: 4,602] | | | [added: | | | | | | | |]

| Income tax [added: (benefit)] provision | [added: | | (751) | | | | | |] 547 | | | | [added: | |] 2,580 | | | | [removed: 578] | | | [added: | | | | | | | |]

| Net income | [added: | | 4,806 | | | | | |] 4,650 | | | | [added: | |] 3,095 | | | | [removed: 4,024] | | | [added: | | | | | | | |]

| Net (income) loss attributable to noncontrolling interests | [removed: (19] | | [removed: )] [added: (17)] | | [added: | | | | (19) | | | | | |] 9 | | | | [removed: 4] | | | [added: | | | | | | | |]

| Net income attributable to Medtronic | [added: | |] $ | [added: 4,789 | | | | | $ |] 4,631 | | | [added: | |] $ | 3,104 | | | [removed: $] | [removed: 4,028] | | [added: | | | | | | | |]

| Basic earnings per share | [added: | |] $ | [added: 3.57 | | | | | $ |] 3.44 | | | [added: | |] $ | 2.29 | | | [removed: $] | [removed: 2.92] | | [added: | | | | | | | |]

| Diluted earnings per share | [added: | |] $ | [added: 3.54 | | | | | $ |] 3.41 | | | [added: | |] $ | 2.27 | | | [removed: $] | [removed: 2.89] | | [added: | | | | | | | |]

| Basic weighted average shares outstanding | [added: | | 1,340.7 | | | | | |] 1,346.4 | | | | [added: | |] 1,356.7 | | | | [removed: 1,378.9] | | | [added: | | | | | | | |]

| Diluted weighted average shares outstanding | [added: | | 1,351.1 | | | | | |] 1,357.5 | | | | [added: | |] 1,368.2 | | | | [removed: 1,391.4] | | | [added: | | | | | | | |]

| | | [added: |] Fiscal Year | | | | | | | | | | | [added: | | | | | | | | | | | | | | | |]

| (in millions) | | [added: | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | | [added: | | | | | | | |]

| Net income | | [added: |] $ | [added: 4,806 | | | | | $ |] 4,650 | | | [added: | |] $ | 3,095 | | | [removed: $] | [removed: 4,024] | | [added: | | | | | | | |]

| Other comprehensive income (loss), net of tax: | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | |]

| Unrealized gain (loss) on investment securities | | [added: | 45 | | | | | |] 102 | | | | [removed: (103] | | [removed: )] [added: (103)] | | [removed: 38] | | | [added: | | | | | | | | | |]

| Translation adjustment | | [removed: (1,375] | [added: (829)] | [removed: )] | | [added: | | | (1,375) | | | | | |] 1,184 | | | | [removed: (977] | | [removed: )] | [added: | | | | | | | |]

| Net investment hedge | | [added: | 405 | | | | | |] 88 | | | | [added: | |] — | | | | [removed: —] | | | [added: | | | | | | | |]

*Change in Accounting Principle*

As discussed in Note 2 to the consolidated financial statements, the Company changed the manner in which it accounts for leases in fiscal year 2020.

accordance with generally accepted accounting principles.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that (i) relate 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 matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

*Litigation Contingencies*

As described in Notes 1 and 19 to the consolidated financial statements, the Company’s consolidated accrued litigation was approximately $0.5 billion as of April 24, 2020.

The Company is involved in a number of legal actions involving product liability, intellectual property and commercial disputes, and shareholder related matters, which represents a significant portion of the total consolidated accrued litigation reserve.

In some actions, the enforcement agencies or private claimants seek damages, as well as other civil or criminal remedies, that could require significant expenditures, result in lost revenues, or limit the Company’s ability to conduct business in the applicable jurisdictions.

Management records liabilities for loss contingencies related to legal actions when a loss is known or considered probable and the amount may be reasonably estimated.

Determining the estimated loss or range of loss requires management to use significant judgment.

The principal considerations for our determination that performing procedures relating to litigation contingencies is a critical audit matter are there was significant judgment by management when assessing whether a loss is probable of being incurred and when determining whether a reasonable estimate of the loss or range of loss for each claim can be made.

This, in turn, led to a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating audit evidence related to management’s judgments, estimated loss or range of loss, and disclosures related to the litigation contingencies.

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 management’s evaluation of litigation claims, including controls over determining whether a loss is probable of being incurred and whether the amount of loss can be reasonably estimated, as well as financial statement disclosures.

These procedures also included, among others, (i) evaluating the reasonableness of management’s assessment regarding whether an unfavorable outcome is reasonably possible or probable and reasonably estimable, (ii) testing management’s process to determine the estimate of the loss or range of loss, (iii) obtaining and evaluating letters of audit inquiry with internal and external legal counsel, and (iv) evaluating the sufficiency of the Company’s litigation contingency disclosures.

*Income Tax Reserves for Uncertain Tax Positions Related to Puerto Rico Manufacturing*

As described in Notes 14 and 19 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 significant remaining unresolved issue with the IRS, for which management has recorded a reserve, 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 sites.

These reserves are subject to a high degree of

estimation and management judgment.

Total reserves relating to uncertain tax positions as of April 24, 2020 were $1.862 billion, of which the Puerto Rico manufacturing reserves make up a significant portion.

The principal considerations for our determination that performing procedures relating to income tax reserves for uncertain tax positions related to Puerto Rico manufacturing is a critical audit matter are there was significant judgment by management when determining the reserves, including a high degree of estimation uncertainty relative to the unresolved matters involving one of the Company’s key manufacturing sites.

This in turn led to a high degree of auditor judgment, effort and subjectivity in performing procedures to evaluate the timely identification and accurate measurement of the reserves.

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 identification and recognition of the reserves for uncertain tax positions, and controls addressing completeness of the uncertain tax positions, as well as controls over measurement of the reserve.

These procedures also included, among others, evaluating management’s process to determine the estimate, evaluating the reasonableness of the underlying assumptions in management’s calculations to support the reserves recorded, including evaluating whether the methodology and assumptions used by the Company are consistent with the tax court’s ruling and examined relevant documents related to the tax court case.

Professionals with specialized skill and knowledge were used to assist in these procedures.

| June 19, 2020 | | |

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| Net income | | | | | | — | | | | | | — | | | | | | — | | | | | | 4,789 | | | | | | — | | | | | | 4,789 | | | | | | 17 | | | | | | 4,806 | | | | | | | | |

| Other comprehensive loss | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (849) | | | | | | (849) | | | | | | (2) | | | | | | (851) | | | | | | | | |

| Stock-based compensation | | | | | | — | | | | | | — | | | | | | 297 | | | | | | — | | | | | | — | | | | | | 297 | | | | | | — | | | | | | 297 | | | | | | | | |

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| June 21, 2019 |

Medtronic plc

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