Medtronic (MDT) Risk Factor Changes

Shareholders entitled to an exemption from Irish dividend withholding tax on dividends received from us will not be subject to Irish income tax in respect of those dividends unless they have some connection with Irela…

Under Irish law, our authorized share capital can be increased by an ordinary resolution of our shareholders and the directors may issue new ordinary or preferred shares, without shareholder approval, once authorized…

As an Irish public limited company, we are required to obtain shareholder approval for certain capital structure decisions, which may limit our flexibility to manage our capital structure.

As an Irish company, we are governed by the Irish Companies Act 2014 (as amended), which differs in some material respects from laws generally applicable to U.S.

Market disruptions resulting in diminished liquidity, or strikes or other work stoppages by healthcare professionals or staff, could adversely affect our revenues, results of operation, or financial condition.

Most of our customers, and the healthcare providers to whom our customers supply medical devices, rely on third-party payors, including government programs and private health insurance plans, to reimburse some or all…

Many healthcare industry companies, including healthcare systems, distributors, manufacturers, providers, and insurers, are consolidating or have formed strategic alliances.

Consolidation in the healthcare industry and the growing prevalence of ASCs could have an adverse effect on our revenues and results of operations.

Changes in the international trade policy of the U.S.

There is continued focus from our stakeholders, as well as regulatory authorities in the U.S., E.U.

certain third-party suppliers involve the use of substances subject to these laws and regulations, primarily those used in manufacturing and sterilization processes.

We are subject to environmental, health, and safety laws, and regulations concerning, among other things, the generation, handling, transportation, and disposal of hazardous substances or wastes, the remediation of ha…

requirements to prevent and prohibit improper practices, including policies, programs, and training for our employees and third-party intermediaries acting on our behalf.

In addition, our information technology systems require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop new systems.

Furthermore, we rely on third-party vendors to supply and/or support certain aspects of our information technology systems and resulting products, and customers and payors use information technology systems to process…

In March 2009, the IRS issued its audit report for Medtronic, Inc.

We have recorded reserves for potential payments of tax to various tax authorities related to uncertain tax positions.

In addition, the laws of certain countries in which we market or manufacture some of our products do not protect our intellectual property rights to the same extent as the laws of the U.S., which could make it easier…

While we intend to defend against threats to our intellectual property, our patents, trademarks, tradenames, copyrights, trade secrets or agreements (such as employee and non-disclosure agreements) may not adequately…

We also are subject to risks relating to changes in government and private medical reimbursement programs and policies, and changes in legal and regulatory requirements in the U.S.

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.

Our failure to comply with laws and regulations relating to reimbursement of healthcare goods and services, or changes to such laws, coverage policies, and payment practices, may subject us to penalties and adversely…

Both before and after a product is commercially released, we have ongoing responsibilities under the U.S.

Our medical devices and technologies, as well as our business activities, are subject to a complex set of regulations and rigorous enforcement, including by the U.S.

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.

We are required to use a portion of our operating cash flow to pay interest or principal on our outstanding indebtedness instead of for other corporate purposes, including funding future expansion of our business.

In addition, the potential exists that expected strategic benefits from any planned or completed divestiture, including the ongoing separation of our Diabetes Business from the Company, or third-party funding arrangem…

Other disruptions in the manufacturing process or product sales, trade and fulfillment systems for any reason, including infrastructure, information and equipment malfunction, including due to cyber attacks, failure t…

The manufacture of our products requires the timely delivery of a sufficient amount of quality components and materials and is highly exacting and complex, due in part to complex trade and strict regulatory requirements.

Our continued growth and success depend on our ability to develop, acquire and market new and differentiated products, technologies and intellectual property, and as a result we also face competition for marketing, di…

Our success depends on our ability to differentiate our products and successfully execute and scale emerging technologies.

Competition may increase as additional companies enter our markets or modify their existing products to compete more directly with ours.

We compete in both the therapeutic and diagnostic medical markets in more than 150 countries throughout the world.

negotiate price concessions.

More generally, several governments including the U.S.

The Russia-Ukraine conflict and resulting sanctions and export restrictions are creating barriers to doing business in Russia and Belarus and adversely impacting global supply chains.

Under Irish law, our authorized share capital can be increased by an ordinary resolution of our shareholders and the directors may issue new ordinary or preferred shares, without shareholder approval, once authorized…

We are incorporated in Ireland, and Irish law differs from the laws in effect in the U.S.

Various U.S.

Legislative or other governmental action relating to the denial of U.S.

Because Medtronic plc is organized under the laws of Ireland, we would generally be classified as a foreign corporation under the general rule that a corporation is considered tax resident in the jurisdiction of its o…

Future potential changes to the U.S.

benefits being recognized in the period when we determine the liabilities are no longer necessary.

harm our sales by designing products that substantially mirror the capabilities of our products or technology without infringing our intellectual property rights.

We also could experience negative effects on our business, results of operations, financial condition, and cash flows from acquisition-related charges, amortization of intangible assets and asset impairment charges.

•our ability to retain key employees, and

As part of our strategy to develop and identify new products and technologies and optimize our portfolio of products, we have made several significant acquisitions, divestitures and third-party research and developmen…

indebtedness, we may be unable to obtain capital market financing with similar terms and currency denomination to our existing indebtedness, or at all, which could have a material adverse effect on our business and re…

tariffs, could adversely impact our supply.

introduction of reprocessed products or generic versions when our proprietary products lose their patent protection may make our existing or planned products less competitive.

they are resident in Ireland).

We are incorporated in Ireland, and our jurisdiction of incorporation may subject us to risks that could adversely affect our business and holders of our securities.

The separation is complex and may require significant management time and resources and result in significant costs, including transaction, advisory, legal, accounting, information technology, separation and stand‑up…

We have commenced the separation of our Diabetes Business, which has been transferred to MiniMed Group, Inc.

The ongoing separation of our Diabetes Business could be delayed, may not be completed as currently contemplated, and could materially adversely affect our business, results of operations, financial condition, and cas…

Risks Relating to the Proposed Separation of Our Diabetes Business

Geopolitical tensions and conflicts have the potential to adversely impact our business.

Global enforcement of anti-corruption laws includes investigations and enforcement proceedings, which could lead to the assessment of significant fines and penalties against companies and individuals.

respond rapidly enough to prevent a negative impact on our business.

We are increasingly dependent on sophisticated information technology systems to operate our business.

Although we expect to be able to rely on applicable tax treaties with the U.S., Ireland, and other jurisdictions in which we have operations, legislative or other action could be taken to override or amend one or more…

In addition, claims may be asserted against us in the future based on new theories of liability or changes in applicable laws or regulations, including as a result of evolving interpretations by courts or regulators.

the frequency, scope, or duration of litigation, including claims that may lack merit, and could result in higher defense costs and greater uncertainty, regardless of the ultimate outcome.

Such matters are inherently uncertain and may be protracted, costly, complex, and disruptive to our operations.

We are, and may in the future be, involved in litigation, claims, disputes, and regulatory or administrative proceedings arising out of the ordinary course of our business, including product liability claims, commerci…

We are subject to litigation, claims, investigations, and regulatory proceedings, which are inherently unpredictable and could materially adversely affect our business, results of operations, financial condition, and…

could delay or reduce adoption, limit utilization, or otherwise have an impact on the acceptance of and demand for our products and the prices that our customers are willing to pay for them.

Our devices, products, and therapies are purchased principally by hospitals or physicians that typically bill various third-party payors, such as governmental healthcare programs (e.g., Medicare, Medicaid and comparab…

our Company and business, including the demand for and supply of certain of our products, operations, supply chains and distribution systems, and our ability to generate cash flow.

We also could experience negative effects on our business, results of operations, financial condition, and cash flows from acquisition-related charges, amortization of intangible assets and asset impairment charges.

•the ability to obtain approval or clearance for the products of any businesses we acquire, or to effectively integrate the products or technologies of those businesses into existing or planned product lines, includin…

divestiture of part of our existing businesses, including the ongoing separation of our Diabetes Business from the Company, requires significant efforts, including the coordination of information technologies, researc…

As part of our strategy to develop and identify new products and technologies and optimize our portfolio of products, we have made several significant acquisitions, divestitures and third-party research and developmen…

effectively or continue our level of success, and failures in execution, delays in adoption, or the inability to integrate new technologies effectively could have an outsized impact on our business, results of operati…

In addition to competition from individual products or companies, rapid technological change may drive shifts in standards of care, physician preferences, purchasing decisions, or site of service dynamics more quickly…