Boston Scientific (BSX) 10-K risk factor changes: FY2022 vs FY2021

The [removed: ongoing] global COVID-19 pandemic and related impacts [removed: are having] [added: have had, and could in the future have,] an adverse effect on our operations, financial performance and cash flows.

We are unable to predict the extent to which the pandemic [added: or a similar health crisis] and related impacts [removed: will continue to] [added: may] adversely impact our business operations, financial performance, results of operations, financial position and the achievement of our strategic objectives.

Our operations, financial performance and cash flows have [removed: been] [added: been, and could in the future continue to be,] negatively impacted by the [removed: ongoing] COVID-19 [removed: pandemic,] [added: pandemic] and the [added: risks and] challenging macroeconomic conditions caused by the pandemic, including, but not limited to, disruptions in economic activity, [removed: including procedures using our products, disruptions in] global supply [removed: chains,] [added: chains and] labor markets, [added: operational challenges such as site shutdowns, workplace disruptions or limited provider capacity to perform procedures using our products that were deferred as a result of the pandemic, volatile financial market dynamics] and significant volatility in price and availability of goods and services.

Because the severity, magnitude, and [added: ultimate] duration of the COVID-19 [removed: pandemic] [added: pandemic, or similar health crisis,] and its economic consequences are uncertain, [removed: rapidly changing,] [added: subject to rapid change,] and difficult to predict, the pandemic’s [added: future potential] impact on our [added: business,] results of operations and financial [removed: performance, as well as its impact on our ability to execute our business strategies and initiatives successfully,] [added: performance] remains uncertain and difficult to predict.

Further, the ultimate impact of the COVID-19 pandemic [added: or similar health crisis] on our results of operations and financial performance depends on many factors that are not within our control, including, but not limited, to: governmental, business and individuals’ actions that have been and [removed: continue to] [added: in the future may] be taken in response to the pandemic [removed: (including restrictions on travel, vaccine mandates, transport and workforce pressures, and voluntary] or [removed: mandated deferrals or postponements of elective procedures);] [added: similar public health crises,] the impact of the pandemic and actions taken in response on global and regional economies, [removed: travel, and economic activity; the availability of federal, state, local or non-U.S. funding programs;] general economic uncertainty in key global markets and financial market [removed: volatility;] [added: volatility,] global economic conditions and levels of economic growth; and [removed: the timing and pace] [added: any continuing economic effects] of [removed: recovery when] the COVID-19 pandemic [removed: subsides, which could be impacted by a number of factors, including limited provider capacity to perform procedures using our products that were deferred as a result of the pandemic.][added: even after it has subsided.]

[removed: Changes in the underlying estimates, assumptions or judgments] [added: and sustainability matters,] could have a material adverse impact on our future results of [removed: operations and/or] [added: operations,] financial [removed: position.][added: position and cash flows.]

[removed: As the] [added: The] COVID-19 pandemic [removed: continues to adversely affect our results of operations and/or financial position, it] [added: and related impacts] may also have the effect of heightening many of the other risks described in the risk factors in this Annual Report on Form 10-K.

Our primary competitors include Abbott Laboratories and Medtronic plc, as well as a wide range of medical device companies that sell a single or limited number of competitive products or which participate in only a specific [removed: market segment or segments.]

We continue to experience pressures across many of our businesses due to competitive activity, increased market power of our customers as the healthcare industry consolidates, national and regional government tenders, economic pressures experienced by our customers, [added: staffing shortages within healthcare facilities that have and may continue to negatively impact demand for our products,] public perception of our products, and the impact of managed care organizations and other third-party payers.

We expect that market demand, government regulation, third-party coverage and reimbursement policies, government contracting requirements and societal pressures will continue to change the worldwide healthcare industry, [added: resulting in further business consolidations and alliances among our customers, which may increase competition, exert further downward pressure on the prices of our products and services and may adversely impact our business, financial condition or results of operations.]

Our products are purchased principally by hospitals, physicians and other healthcare providers around the world that typically bill various third-party payers, including government programs, authorities or agencies (e.g., Medicare and Medicaid in the U.S.) and private health plans, for the healthcare [added: supplies and] services provided to their patients.

Governments and payers may [removed: also] institute changes in healthcare delivery [added: or payment] systems that may reduce funding for services or encourage greater scrutiny of healthcare costs.

We may find limited demand for [added: otherwise] promising new products unless reimbursement approval is obtained from private and governmental third-party payers.

Further legislative or administrative reforms to the reimbursement systems in the U.S., Japan, [added: China,] or other countries in a manner that significantly reduce or eliminate reimbursement for procedures using our medical devices, including price regulation, site of service requirements, competitive bidding and tendering, coverage and payment policies, comparative effectiveness of therapies, heightened clinical data requirements, technology assessments and managed-care arrangements, could have a material adverse effect on our business, financial condition or results of operations

International net sales accounted for [removed: 42] [added: 40] percent of our global net sales in [removed: 2021.][added: 2022.]

Our international operations are subject to a number of market, business and financial risks and uncertainties, including those related to our use of channel partners, [added: go-to-market strategies,] geopolitical and economic instability, foreign currency exchange and interest rate fluctuations, competitive product offerings, local changes in healthcare financing and payment systems and healthcare delivery systems, local product preferences and requirements, including preferences for local manufacturers, workforce instability, weaker intellectual property protection in certain countries than exists in the U.S. and longer accounts receivable cycles.

[added: Global businesses, including those in the] medical device industry, are facing increasing scrutiny of, and heightened enforcement efforts with respect to, their international operations.

[removed: Any alleged or actual failure to comply with legal and regulatory requirements may subject us to] government scrutiny, civil and/or criminal proceedings, sanctions and other liabilities, which may have a material adverse effect on our international operations, financial condition, results of operations and/or liquidity.

Lastly, sanctions and export restrictions are expected to [added: continue to] proliferate, leading to greater uncertainty in emerging and growth markets.

Notably the [removed: Russia-Ukraine crisis is expected to create] [added: Russia/Ukraine war has created] barriers to doing business in Russia, [removed: as well as creating] [added: and the tension between China/Taiwan has created] geopolitical shifts in Asia.

Our outstanding debt balance was [removed: $9.065] [added: $8.935] billion as of December 31, [removed: 2021.][added: 2022.]

Delays in our product development and new product launches could result in disruption in our cash flow or our ability to continue to effectively manage our debt [removed: levels] [added: levels, which] could have an adverse effect on our cost of borrowing, financial condition or results of operations.

[removed: Current] [added: Challenging] domestic and international economic conditions could adversely affect our [added: business, financial condition,] cash flows and results of operations.

[removed: Uncertainty] [added: Further, uncertainty] about global economic conditions, including those resulting from credit and sovereign debt issues, has caused and may continue to cause disruption in the financial markets, including diminished liquidity and credit availability.

Deterioration of the global economy or increase in sovereign debt issues may impact our ability to transfer receivables to third [added: parties in certain of those countries.]

[removed: The strength and timing of economic recovery remains uncertain and there] [added: There] can be no assurance that there will not be further deterioration in the global economy.

Accordingly, we cannot predict to what extent global economic conditions, including [added: negative or uncertain economic conditions,] sovereign debt issues and increased focus on healthcare systems and costs in the U.S. and abroad, may [removed: continue to] impact negatively our average selling prices, net sales and profit margins, [added: operations,] procedural volumes and reimbursement rates from third party payers.

In addition, [removed: conditions in the] [added: economic and] financial [removed: markets] [added: market conditions, including rising interest rates,] and other factors beyond our control may adversely affect our ability to borrow money in the credit markets, access the capital markets and obtain financing for mergers and acquisitions (M&A) or other general purposes.

[removed: Some of the factors that could affect the success of our acquisitions include, among others, the effectiveness of our due diligence process, our ability to execute our business plan for the acquired companies, the] strength of the acquired technology, results of clinical trials, regulatory approvals and reimbursement levels of the acquired products and related procedures, the continued performance of critical transition services, our ability to adequately fund acquired in-process research and development projects and retain key employees and our ability to achieve synergies with our acquired companies, such as increasing sales of our products, achieving cost savings and effectively combining technologies to develop new products.

In addition, we cannot be certain that the businesses we acquire will become profitable or remain so, and if our acquisitions are not successful, we may record related asset impairment charges in the future or experience other negative consequences on our [added: operating] results.

We may not be successful in our strategy relating to future strategic acquisitions of, investments in, or alliances with, other companies and [removed: businesses, which have been a significant source of historical growth for us, and will be key to our diversification into new markets and technologies.][added: businesses.]

[removed: Strength in the] [added: The] market for IPOs may also reduce the opportunities available to us for M&A and/or cause us to need to pay higher prices.

If we are unsuccessful in our acquisitions, investments and alliances, [removed: we] [added: it] may [removed: be unable] [added: adversely impact our ability] to grow our business.

- protect intellectual property and [removed: to] prevail in litigation related to newly acquired technologies.

As a result of these assessments, we have undertaken [added: prior] restructuring and optimization initiatives to enhance our growth potential and position us for long-term success.

[removed: In November 2018,] [added: On February 22, 2023, our Board of Directors approved, and] we [removed: announced] [added: committed to,] a [added: new global] restructuring [removed: initiative] [added: program] (the [removed: 2019] [added: 2023] Restructuring Plan) intended to support our [removed: effort] [added: efforts] to [removed: improve] [added: expand] operating performance and meet [removed: anticipated] [added: evolving global] market demands [added: and conditions] by ensuring that we are [removed: appropriately] structured and resourced to [added: support our strategic imperatives and] deliver sustainable [removed: value to patients and customers.][added: value.]

The [removed: 2019] [added: 2023] Restructuring Plan is expected to result in total pre-tax charges of approximately [removed: $425] [added: $450] million to [removed: $525] [added: $550] million and reduce gross annual pre-tax expenses by approximately [removed: $250] [added: $225] million to [removed: $300] [added: $275] million by the end of [removed: 2023] [added: 2025] as program benefits are realized.

These measures could yield unintended consequences, such as distraction of our management and employees, [added: reduced employee productivity,] business disruption, [added: and] inability to attract or retain key [removed: personnel and reduced employee productivity,] [added: personnel,] which could negatively affect our business, sales, financial condition and results of operations.

Moreover, our restructuring and optimization initiatives result in charges and expenses [removed: some of] which impact [removed: our operating results.]

Interruption of our supply chain or manufacturing operations, including resulting from natural disasters, further public [removed: heath] [added: health] crises and other catastrophic events or other events outside of our [removed: control] [added: control,] could adversely affect our results of operations and financial condition.

General Risks

Uncertainty around inflationary pressures, rising interest rates and monetary policy could potentially cause new, or exacerbate existing, economic challenges that we may face.

These conditions could worsen, or others could arise, if the U.S. and global economies were to enter recessionary periods, triggered or exacerbated by monetary policy designed to curb inflation.

If there were a general economic downturn, we may experience decreased customer spending or demand for our products and services, and our customers’ ability to pay for our products on a timely basis, or at all, may be impacted.

The same economic conditions could also adversely affect our third-party vendors, including those that we utilize in our supply-chain and manufacturing operations, which may lead to a reduction or interruption in the supply of materials and components used in manufacturing our products or increase the price of such materials or components, as well as the distributors and dealers who offer our products in certain countries and markets.

Inflationary pressure may also increase certain operational costs, including due to wage increases, or increases in the cost of materials or components.

These adverse economic conditions or events could adversely affect our business, results of operations or financial condition.

Uncertain or challenging economic conditions could also lead to greater fluctuations in foreign currency exchange rates, which could adversely impact our results of operations and financial performance.

market segment or segments.

Governments and payers may also institute changes in healthcare delivery systems that may reduce funding for services, seek payback from market participants, or encourage greater scrutiny of healthcare costs.

Any alleged or actual failure to comply with legal and regulatory requirements may subject us to

The US-China relationship will continue to shape the geopolitical stage.

We may also face greater competition in China, among other countries, from domestic medical device companies that may benefit from their status as local manufacturers and suppliers.

Uncertain or negative economic conditions, as well as rising interest rates, could also increase our cost of borrowing in the future or reduce our access to liquidity.

Some of the factors that could affect the success of our acquisitions include, among others, the effectiveness of our due diligence process, our ability to execute our business plan for the acquired companies, the

The 2023 Restructuring Plan will further build on our Global Supply Chain Optimization strategy, which is intended to simplify our manufacturing and distribution network by transferring certain production lines among facilities and expanding operational efficiencies and resiliency.

Key activities under the 2023 Restructuring Plan will also include optimizing certain functional capabilities to better support business growth and achieve cost synergies.

These activities are expected to be initiated in the first quarter of 2023, and substantially completed by the end of 2025.

While we expect limited role reductions as a result of these restructuring activities, we anticipate that our overall employee base will remain relatively unchanged upon completion of the 2023 Restructuring Plan as new jobs are created in areas of growth and resources are deployed to support an expanding portfolio and growing global market needs.

our operating results.

These and other risks and uncertainties related to the COVID-19 pandemic and its related impacts could adversely affect our business operations, financial position, results of operations and the achievement of strategic objectives.

Factors such as a failure to follow specific

Further, uncertain or negative economic conditions, including as a result of inflationary pressures, rising interest rates or impacts from the COVID-19 pandemic, could negatively affect our third-party vendors, which could lead to a reduction or interruption in the supply of materials and components used in manufacturing our products or increase the price of such materials or components.

If we are unable to attract or retain key talent, it could have an adverse effect on our business, financial condition and results of operations.

In our industry, there is substantial competition for key personnel in the regions in which we operate and we may face increased competition for such employees.

Our business depends to a significant extent on the continued service of senior management and other key personnel, the development of additional management personnel and the hiring of new qualified employees.

There can be no assurance that we will be successful in retaining and developing existing personnel or recruiting new personnel.

The loss of one or more key employees, our ability to attract or develop additional qualified employees or any delay in hiring key personnel could have material adverse effects on our business, financial condition or results of operations.

A shortage of skilled labor could also require higher wages that would increase labor costs.

Updates to the legislative text of the EU MDR were adopted by the European Parliament and are currently being reviewed for adoption by the Council of the European Union, including an extension of the transitional period to 2027 for class IIb and III and 2028 for class I and IIa medical devices which have a valid CE Certificate to the prior Directives (issued before May 2021).

business practices and operations.

Pillar One focuses on how profits are allocated between taxing jurisdictions and Pillar Two creates a 15% global minimum tax.

On December 31, 2022 South Korea became the first country to enact Pillar Two into national law.

On December 15, 2022, the Council of the (EU) European Union unanimously adopted a directive intended to provide EU member states a framework to implement the Pillar Two global minimum tax into their national laws by 2024.

Additional countries including the United Kingdom and Japan are taking steps to implement Pillar Two into their national law.

Currently, significant uncertainty exists regarding the detailed Pillar Two rules, whether such rules will be implemented consistently across taxing jurisdictions, how such rules interact with existing national tax laws and whether such rules are consistent with existing tax treaty obligations.

Accordingly, the final adoption, implementation, and interpretation of Pillar Two across all jurisdictions where we do business could have a material adverse impact on our financial position, results of operations, and cash flows.

Various other factors may also cause system failures or security breaches, including power outages, natural disasters, inadequate or ineffective backups, issues with upgrading or creating new systems or platforms, vulnerabilities in third-party software or services, errors by our staff or third-party service providers, or breaches in the security of these technologies.

Malicious actors may attempt to trick staff to disclose information to gain access to our systems and/or data.

If our incident response, disaster

COVID-19 Risks

These conditions and others may persist and worsen, leading to broader economic downturns, including another U.S. and global economic recession.

The COVID-19 pandemic has subjected, and may continue to subject, our results of operations, financial performance and financial condition to a number of risks, including, but not limited to those discussed below:

- *Operations-related risks*: Across our businesses, we have faced operational challenges from the need to protect employee health and safety.

Some of these challenges include site shutdowns, workplace disruptions and restrictions on the movement of people, raw materials and goods, both at our facilities and at customers and suppliers'.

We also experienced, and may continue experiencing, lower demand and volume for certain products and services, customer requests for payment deferrals or other contract modifications, delays of deliveries and other factors related directly and indirectly to the COVID-19 pandemic that adversely impact our businesses.

We are also experiencing increases in prices for, and shortages of, certain parts or components required to manufacture certain of our products.

We expect that the longer the period of economic and global supply chain disruption continues, the more material the cumulative adverse impact will be on our business operations, financial performance and results of operations.

Our ability to manufacture our products is highly dependent on our ability to maintain the safety and health of our employees.

The ability of our employees to work may be significantly impacted by employees contracting or being exposed to COVID-19.

Additionally, when economic recovery following the COVID-19 pandemic occurs, we may experience unpredictable increases in demand for certain products, which could exceed our capacity to meet such demand on a timely basis or at all, which could have a material adverse impact on our financial performance and results of operations.

- *Customer-related risks*: In particular, as a result of impacts associated with preventive and precautionary measures that we, other businesses and governments have taken to quell the spread of COVID-19 and protect our customers, employees, and the patients receiving our products, we have experienced significant and unpredictable reductions in demand for certain of our products as health care customers re-prioritize the treatment of patients.

In certain jurisdictions in the U.S., governmental authorities have recommended, and in certain cases required, that elective procedures be suspended or canceled to avoid non-essential patient exposure to medical environments and potential

infection with COVID-19 and to focus limited resources and personnel capacity toward the treatment of COVID-19.

Further, staffing shortages within healthcare facilities, and resulting procedural delays, have and may continue to negatively impact demand for our products.

These measures and challenges significantly reduced our net sales and could continue to do so in the future.

Further, once the pandemic subsides, we anticipate there may be some continued reluctance upon the part of some patients to seek medical attention in a hospital setting.

In addition, for the majority of patients who do seek appointments with physicians and surgeries to be performed at hospitals and ambulatory surgery centers relating to a variety of medical conditions, we anticipate there may be a substantial backlog.

As a result, patients seeking to schedule or reschedule elective or deferrable procedures utilizing our products may have to navigate potentially limited healthcare provider capacity.

We believe this on-going patient reluctance and potential healthcare provider capacity could continue to have an adverse effect on our net sales.

- *Employee-related risks*: The severity, magnitude, and duration of the COVID-19 pandemic and its economic consequences are uncertain, rapidly changing, and difficult to predict, and we may have to take actions to reduce costs and preserve jobs, including reductions to salary and work hours, restructuring, layoffs and other measures, which may negatively impact our workforce and our business.

These negative impacts could include inhibiting our ability to quickly respond to increased customer demand and to take advantage of more favorable economic and market conditions after the pandemic subsides as well as lower productivity and higher employee attrition.

- *Accounting-related risks:* Generally accepted accounting principles and the related authoritative guidance are complex and involve subjective judgments.

In particular, the accounting for revenue, inventory, goodwill, intangible assets, income taxes and other assets and liabilities requires reliance on forward looking estimates of sales and/or results of operations.

Due to the uncertainty surrounding the COVID-19 pandemic, estimating the future performance of our business is extremely challenging and the range of deviation from internal estimates could be more significant in this environment.

- *Leverage- and market-related risks*: The current financial market dynamics and volatility pose heightened risks to our previously announced timelines for decreasing our leverage, which we expect to be delayed as we seek to maintain appropriate liquidity to compensate for lower cash flows from operations or as variables impacting our leverage ratios fluctuate with extreme market volatility.

- *Liquidity- and funding-related risks*: While we have significant sources of cash and liquidity and access to committed credit lines, a prolonged period of generating lower cash from operations could adversely affect our financial condition and the achievement of our strategic objectives.

Additionally, there can also be no assurance that we will not face credit rating downgrades as a result of weaker than anticipated performance of our businesses, slower progress in decreasing our leverage or other factors.

Future downgrades could further adversely affect our cost of funds and related margins, liquidity, competitive position and access to capital markets, and a significant downgrade could have an adverse commercial impact on our business.

Conditions in the financial and credit markets may also limit the availability of funding or increase the cost of funding (including for receivables monetization or supply chain finance programs, as well as increased borrowing costs and higher interest rates), which could adversely affect our business, financial position and results of operations.

Although the U.S. federal and other governments have instituted and/or announced a number of funding programs to support businesses, our ability or willingness to access funding under such programs may be limited by regulations or other guidance, or by further change or uncertainty related to the terms of these programs.

Further, the COVID-19 pandemic may also affect our results of operations and/or financial position in a manner that is not presently known to us or that we currently do not expect to present significant risks, particularly if the COVID-19 pandemic and its associated impacts reoccur in successive waves.

resulting in further business consolidations and alliances among our customers, which may increase competition, exert further downward pressure on the prices of our products and services and may adversely impact our business, financial condition or results of operations.

Global businesses, including those in the

The US-China relationship will continue to shape the geopolitical stage, with uncertainty created by the change in administration and strategic direction, and difficult political conditions for major actions.

parties in certain of those countries.

These acquisitions, investments and alliances have been a significant source of our growth.

Key activities under the 2019 Restructuring Plan include supply chain network optimization intended to maximize our global manufacturing and distribution network capacity and building functional capabilities that support business growth.

These activities were initiated in 2019, with the majority of activity expected to be complete by the end of 2022, following a one-year extension approved by our Board of Directors on February 22, 2021.

In addition, on February 22, 2022, the Company increased and our Board of Directors approved cost estimates to complete additional activities identified under the program.

The following discussion and analysis provides information management believes to be relevant to understanding the financial condition and results of operations of Boston Scientific Corporation and its subsidiaries for the years ended December 31, [removed: 2021] [added: 2022] and [removed: 2020.][added: 2021.]

For additional information on our financial condition and results of operations for the year ended December 31, [removed: 2019,] [added: 2020,] refer to our previously filed Annual Report on Form 10-K.

[removed: Procedural delays from] [added: Further,] the [removed: further] resurgence of COVID-19 infections and the emergence of new, more contagious variant strains of COVID-19, as well as staffing shortages within healthcare facilities, [removed: have and] may [removed: continue to] negatively impact demand for our products, net sales, gross profit margin and operating expenses as a percentage of net sales.

[removed: Further,] [added: In 2022,] we [removed: face and may continue to face,] [added: experienced] increases in [removed: the] cost and limited availability of raw materials, components, and other inputs necessary to manufacture and distribute our products due to constraints [added: and inflation] within the global supply chain, as well as increases in [added: wage costs and] the cost and time to distribute our products.

While [removed: we expect] the COVID-19 pandemic [removed: will] [added: and related impacts may] continue to negatively impact our performance to an extent, we continue to believe our long-term fundamentals remain strong and we [removed: will] [added: intend to] manage through these challenges with strategic focus and the winning spirit of our global team.

In 2021, we generated net sales of $11.888 [removed: billion, as] [added: billion] compared to $9.913 billion in 2020.

[removed: This increase of $1.975 billion, or 19.9 percent,] [added: Operational net sales growth] included [removed: operational] [added: organic2 net sales] growth of [removed: 18.7] [added: 8.7] percent [added: in 2022] and the positive impact of [removed: 130] [added: 240] basis points from [removed: foreign currency fluctuations.1 Operational net sales included $212 million in 2021 associated with] our acquisitions of Preventice Solutions, Inc. (Preventice), Farapulse, Inc. [removed: (Farapulse) and] [added: (Farapulse),] the global surgical business of Lumenis, LTD [removed: (Lumenis),] [added: (Lumenis) and Baylis Medical Company Inc. (Baylis Medical)] for which there [removed: were no prior] [added: is less than a full] period [added: of comparable] net sales.

The increase in our [added: 2021] net sales was primarily driven by the recovery of elective and semi-emergent procedure volumes compared to [removed: the prior year] [added: 2020] when the COVID-19 pandemic had a more significant impact on our net sales.

Our reported results for 2021 included certain charges and/or credits [added: which are excluded by management for purposes of assessing operating performance,] totaling $1.351 billion (after-tax), or $0.94 per diluted share.

Excluding these items, adjusted net income available to common [removed: stockholders] [added: stockholders1] for 2021 was $2.336 billion, or $1.63 per diluted [removed: share.1,2][added: share.]

Our reported net [removed: loss] [added: income] available to common stockholders in [removed: 2020] [added: 2022] was [removed: $115] [added: $642] million, or [removed: $0.08] [added: $0.45] per diluted share.

Our reported results for [removed: 2020] [added: 2022] included certain charges and/or credits [added: which are excluded by management for purposes of assessing operating performance,] totaling [removed: $1.492] [added: $1.816] billion (after-tax), or [removed: $1.04] [added: $1.26] per diluted share.

Excluding these items, adjusted net income [added: available to common stockholders1] for [removed: 2020] [added: 2022] was [removed: $1.378] [added: $2.459] billion, or [removed: $0.96] [added: $1.71] per diluted [removed: share.1,2][added: share.]

1 Operational net sales growth rates, which exclude the impact of foreign currency [removed: fluctuations] [added: fluctuations,] and [added: other] adjusted measures, [added: including organic net sales,] which exclude certain items required by generally accepted accounting principles in the United States (U.S. GAAP), are not prepared in accordance with U.S. GAAP and should not be considered in isolation from, or as a replacement for, the most directly comparable GAAP measure.

| [removed: Goodwill and other intangible] [added: Intangible] asset impairment charges | | | 370 | | | (51) | | | 318 | | | — | | | 318 | | | 0.22 | | |

(3) For [added: 2022 and] 2021, the effect of assuming the conversion of [removed: MCPS] [added: our Series A 5.5% Mandatory Convertible Preferred Stock (MCPS)] into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS.

| | | | Year Ended December 31, [removed: 2020] [added: 2022] | | | | | | | | | | | | | | | | | |

| *(in millions, except per share data)* | | | Income (Loss) Before Income Taxes | | | Income Tax Expense (Benefit) | | | Net Income (Loss) | | | Preferred Stock Dividends | | | Net Income (Loss) Available to Common Stockholders | | | Impact per [removed: Share(4)] [added: Share(3)] | | |

| Acquisition/divestiture-related net charges (credits) | | | [removed: 196] [added: 285] | | | [removed: (81)] [added: 53] | | | [removed: 115] [added: 338] | | | — | | | [removed: 115] [added: 338] | | | [removed: 0.08] [added: 0.24] | | |

[removed: | Restructuring] [added: *Restructuring] and [removed: restructuring-related net charges (credits) | | | 171 | | | (25) | | | 146 | | | — | | | 146 | | | 0.10 | | |][added: Restructuring-related Net Charges*]

| Litigation-related net charges (credits) | | | [removed: 278] [added: 173] | | | [removed: (17)] [added: (40)] | | | [removed: 261] [added: 133] | | | — | | | [removed: 261] [added: 133] | | | [removed: 0.18] [added: 0.09] | | |

| Investment portfolio net losses (gains) | | | [removed: (429)] [added: (30)] | | | [removed: 98] [added: 2] | | | [removed: (331)] [added: (28)] | | | — | | | [removed: (331)] [added: (28)] | | | [removed: (0.23)] [added: (0.02)] | | |

| European Union (EU) Medical device regulation (MDR) implementation costs | | | [removed: 29] [added: 71] | | | [removed: (3)] [added: (10)] | | | [removed: 25] [added: 62] | | | — | | | [removed: 25] [added: 62] | | | [removed: 0.02] [added: 0.04] | | |

| Deferred tax expenses (benefits) | | | — | | | [removed: 41] [added: 140] | | | [removed: 41] [added: 140] | | | — | | | [removed: 41] [added: 140] | | | [removed: 0.03] [added: 0.10] | | |

| Discrete tax items | | | — | | | [removed: 69] [added: 129] | | | [removed: 69] [added: 129] | | | — | | | [removed: 69] [added: 129] | | | [removed: 0.05] [added: 0.09] | | |

Our Endoscopy business develops and manufactures devices to diagnose and treat a broad range of gastrointestinal [removed: (GI)] and pulmonary conditions with innovative, less invasive technologies.

[removed: Our net] [added: Net] sales of Endoscopy products of [removed: $2.141] [added: $2.221] billion represented 18 percent of our consolidated net sales in [removed: 2021.][added: 2022.]

[removed: Our] Endoscopy net sales increased [removed: $361] [added: $80] million, or [removed: 20.3] [added: 3.7] percent, in [removed: 2021, as] [added: 2022] compared to [removed: 2020.][added: 2021.]

This increase included operational net sales growth of [removed: 18.9] [added: 8.1] percent and the [removed: positive] [added: negative] impact of [removed: 130] [added: 440] basis points from foreign currency [removed: fluctuations, as compared to 2020.][added: fluctuations.]

Our Urology [removed: and Pelvic Health] business develops and manufactures devices to treat various urological and pelvic conditions for both male and female [removed: anatomies.][added: anatomies, including kidney stones, benign prostatic hyperplasia (BPH), prostate cancer, erectile dysfunction and incontinence.]

[removed: Our net] [added: Net] sales of Urology [removed: and Pelvic Health] products of [removed: $1.583] [added: $1.773] billion represented [removed: 13] [added: 14] percent of our consolidated net sales in [removed: 2021.][added: 2022.]

This increase included operational net sales growth of [removed: 22.1] [added: 14.9] percent and the [removed: positive] [added: negative] impact of [removed: 100] [added: 290] basis points from foreign currency [removed: fluctuations, as compared to 2020.][added: fluctuations.]

Operational net sales growth included organic net sales growth of [removed: 19.2] [added: 9.7] percent in [removed: 2021] [added: 2022] and the [removed: net] positive impact of [removed: 280] [added: 530] basis points [removed: due to] [added: from] our [removed: Lumenis, LTD. (Lumenis)] acquisition [removed: less the impact] of [removed: the divestiture of the Intrauterine Health business] [added: Lumenis] in the [removed: second] [added: third] quarter of [removed: 2020.][added: 2021.]

[removed: Our net] [added: Net] sales of [removed: CRM] [added: Cardiology] products of [removed: $2.019] [added: $5.932] billion represented [removed: 17] [added: 47] percent of our consolidated net sales in [removed: 2021.][added: 2022.]

This increase included operational net sales growth of [removed: 17.1] [added: 3.5] percent and the [removed: positive] [added: negative] impact of [removed: 140] [added: 260] basis points from foreign currency [removed: fluctuations, as compared to 2020.][added: fluctuations.]

[removed: Our net] [added: Net] sales of [removed: Electrophysiology] [added: Neuromodulation] products of [removed: $365] [added: $917] million represented [removed: three] [added: seven] percent of our consolidated net sales in [removed: 2021.][added: 2022.]

[removed: Our Electrophysiology] [added: Peripheral Interventions] net sales increased $79 million, or [removed: 27.4] [added: 4.4] percent, in [removed: 2021, as] [added: 2022] compared to [removed: 2020.][added: 2021.]

This increase included operational net sales growth of [removed: 25.8] [added: 14.5] percent and the [removed: positive] [added: negative] impact of [removed: 160][added: 510 basis points from foreign currency fluctuations.]

Our [added: Emerging Markets] net sales [removed: of Neuromodulation products of $909 million] represented [removed: eight] [added: 14] percent of our consolidated net sales in [added: 2022 and 12 percent in] 2021.

Neuromodulation net sales increased [removed: $148] [added: $8] million, or [removed: 19.5] [added: less than one] percent, in [removed: 2021, as] [added: 2022] compared to [removed: 2020.][added: 2021.]

Economic Trends

Uncertainty around inflationary pressures, rising interest rates, monetary policy and changes in tax laws could potentially cause new, or exacerbate existing, economic challenges that we may face, including the impact of foreign currency fluctuations on our results of operations.

These conditions could worsen, or others could arise, if the U.S. and global economies were to enter recessionary periods, triggered or exacerbated by monetary policy designed to curb inflation.

Existing and future potential geopolitical dynamics, including matters related to the Russia/Ukraine war, as well as the tension between China/Taiwan, may create economic, supply chain, energy, and other challenges, which impact, and may in the future negatively impact our business.

In particular, international conflicts may result in sanctions, tariffs, and other measures that restrict international trade and negatively affect our business operations and results.

In 2023, we expect the impact of macroeconomic and supply chain conditions on our business to be similar to 2022.

Economic conditions created in part by the COVID-19 pandemic, have had, and may in the future have, a negative impact on our profitability.

In 2022, we generated net sales of $12.682 billion, compared to $11.888 billion in 2021.

The increase in our net sales was primarily driven by recent acquisitions as well as the strength and diversity of our product portfolio coupled with growth in the underlying markets in which we compete and strong commercial execution.

2 Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales.

| Reported | | | $ | 1,141 | | $ | 443 | | $ | 698 | | $ | (55) | | $ | 642 | | $ | 0.45 | |

| Amortization expense | | | 803 | | | (109) | | | 694 | | | — | | | 694 | | | 0.48 | | |

| Debt extinguishment charges | | | 194 | | | (45) | | | 149 | | | — | | | 149 | | | 0.10 | | |

| Adjusted | | | $ | 2,880 | | $ | 366 | | $ | 2,514 | | $ | (55) | | $ | 2,459 | | $ | 1.71 | |

In the first quarter of 2022, we reorganized our operational structure and have aggregated our core businesses, each of which generate revenues from the sale of medical devices into two reportable segments: MedSurg and Cardiovascular.

Within the Cardiovascular segment, the newly formed Cardiology division represents the combined former Rhythm Management and Interventional Cardiology divisions.

These year-over-year changes were primarily driven by our biliary franchise led by our AXIOS™ Stent and Delivery System and our single-use imaging franchise, including our EXALT™ D Single-use Duodenoscope, as well as our infection prevention and hemostasis franchises.

Urology

Urology net sales increased $190 million, or 12.0 percent, in 2022 compared to 2021.

Organic net sales growth was driven by our stone management franchise led by our LithoVue™ System, our prosthetic urology franchise and our prostate health franchise led by our Rezum™ System and SpaceOAR™ Hydrogel.

Operational net sales performance reflects growth within our spinal cord stimulation (SCS) franchise driven by our WaveWriter Alpha™ SCS System, strong procedural volumes of our Vercise Genus™ DBS systems as well as the recent launch of the Vercise™ 2-in-1 lead extension, largely offset by the impact of reimbursement challenges in the U.S. related to our Vertiflex Superion™ Indirect Decompression System.

Operational net sales growth included organic net sales growth of 10.4 percent in 2022 and the positive impact of 400 basis points from our acquisitions of Preventice, Farapulse and Baylis Medical in the first and third quarter of 2021 and the first quarter of 2022, respectively.

Organic sales growth was primarily driven by continued market expansion of Left Atrial Appendage Closure (LAAC) procedures with our WATCHMAN™ FLX LAAC Device, as well as performance of our cardiac diagnostics franchise, POLARx™ and Farapulse™ ablation systems and percutaneous coronary intervention guidance franchises.

Operational net sales growth was primarily driven by our Ranger™ Drug-Coated Balloon and Eluvia™ Drug-Eluting Stent System, as well as our interventional oncology franchise led by our Therasphere™ Y-90 Radioactive Glass Microspheres.

Operational net sales growth was driven primarily by growth in China and India as we continued to focus on globalization and execute new product launches.

| Urology | | | 1,773 | | | | | | 1,583 | | | | | | 1,286 | | | | | | 12.0% | | | | | | 23.1% | | |

| MedSurg | | | 4,911 | | | | | | 4,633 | | | | | | 3,827 | | | | | | 6.0% | | | | | | 21.0% | | |

| Cardiology | | | 5,932 | | | | | | 5,422 | | | | | | 4,290 | | | | | | 9.4% | | | | | | 26.4% | | |

| Cardiovascular | | | 7,831 | | | | | | 7,242 | | | | | | 5,866 | | | | | | 8.1% | | | | | | 23.4% | | |

| | | | 12,742 | | | | | | 11,875 | | | | | | 9,694 | | | | | | 7.3% | | | | | | 22.5% | | |

| Other(4) | | | (60) | | | | | | 13 | | | | | | 219 | | | | | | (+100.0)% | | | | | | (93.9)% | | |

(4) In 2022, amounts reflect sales reserves established for Italian government payback provisions, not allocated to reportable segments, which are being disputed in the Italian court system.

In 2021 and 2020, amounts relate to our Specialty Pharmaceuticals business.

Prior to the divestiture, we presented the Specialty Pharmaceuticals business as a standalone operating segment alongside our reportable segments.

Operational net sales included $212 million in 2021 associated with our acquisitions of Preventice, Farapulse and Lumenis, for which there was less than a full prior period of comparable net sales.

| Manufacturing and supply costs | | | (0.6)% | | |

| | | | | | |

| | | | | | |

Our gross profit margin for 2022 was flat compared to 2021.

Global supply chain disruption drove increased manufacturing and supply costs, including inflation on costs of certain raw materials and components, direct labor and freight, as well as inefficiencies in our manufacturing plants due to constraints in material availability.

In December 2019, the novel strain of coronavirus (SARS-Cov-2), and its disease commonly known as COVID-19 (COVID-19), was reported in China and has since widely impacted the global public health and economic environment.

While the majority of procedures using our products are deferrable, most of the conditions that we treat are generally fairly acute and cannot be deferred for extended periods.

As the pandemic spread worldwide, many elective and semi-emergent procedures have been postponed, particularly during the second half of 2020 and first half of 2021, enabling hospital staff to focus critical resources on caring for COVID-19 patients.

Because the severity, magnitude, and duration of the COVID-19 pandemic and its economic consequences continue to be uncertain, the pandemic’s impact on our operations and financial performance, as well as its impact on our ability to execute our business strategies and initiatives successfully, remains uncertain and difficult to predict.

In addition, conditions created by the COVID-19 pandemic, the economic recovery that has followed in many areas and other macroeconomic factors have led to a challenging labor market in which we compete, which affects our ability to retain and attract new talent as well as put inflationary pressure on certain operational costs due to wage increases.

We continue to focus our efforts on the health and safety of patients, healthcare providers and employees, while executing our mission of transforming lives through innovative medical solutions to improve the health of patients around the world.

Since the onset of the COVID-19 pandemic, our global crisis management team has focused on protecting our employees and customers, optimizing our operations and securing our supply chain.

We have successfully implemented business continuity plans including establishing a medical advisory group for employees, leveraging work from home infrastructure to facilitate social distancing and accelerating capabilities to provide remote physician support.

We will continue to be guided by our values and mission and monitor our return-to-office strategy based on science and data for the health and safety of our employees.

2In May 2020, we completed an offering of 10,062,500 shares of 5.50% Mandatory Convertible Preferred Stock, Series A (MCPS) at a price to the public and liquidation preference of $100 per share.

Refer to the reconciliations below for the impact of the MCPS cumulative preferred stock dividends on our calculations of earnings per share (EPS).

Accordingly, GAAP *Net income (loss)* and Adjusted net income were reduced by cumulative *Preferred stock dividends*, as presented in our consolidated statements of operations, for purposes of calculating GAAP *Net income (loss) available to common stockholders*.

| Reported | | | $ | (79) | | $ | 2 | | $ | (82) | | $ | (33) | | $ | (115) | | $ | (0.08) | |

| Amortization expense | | | 789 | | | (88) | | | 701 | | | — | | | 701 | | | 0.49 | | |

| Goodwill and other intangible asset impairment charges | | | 533 | | | (68) | | | 465 | | | — | | | 465 | | | 0.32 | | |

| Adjusted | | | $ | 1,488 | | $ | 77 | | $ | 1,411 | | $ | (33) | | $ | 1,378 | | 0.96 | | |

(4) For 2020, the effect of assuming the conversion of MCPS into shares of common stock was anti-dilutive, and therefore excluded from the calculation of EPS.

We have assumed dilution of 13.8 million common stock equivalents related to employee stock options for all or a portion of the non-GAAP adjustments, which were anti-dilutive for GAAP purposes due to our *Net loss* position.

These year-over-year changes were primarily driven by our biliary, single-use imaging, hemostasis and infection prevention franchises due to the recovery of elective and semi-emergent procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales.

Urology and Pelvic Health

Urology and Pelvic Health net sales increased $297 million, or 23.1 percent, in 2021, as compared to 2020.

In the third quarter of 2021, we completed the acquisition of the global surgical business of Lumenis, a privately-held company that develops and commercializes energy-based medical solutions, including innovative laser systems, fibers and accessories used for urology and otolaryngology procedures.

Organic net sales growth was driven by our stone management and prostate health franchises and prosthetic urology franchise due to the recovery of elective and semi-emergent procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales.

Rhythm and Neuro

Cardiac Rhythm Management

Our Cardiac Rhythm Management (CRM) business develops and manufactures a variety of implantable devices that monitor the heart and deliver electricity to treat cardiac abnormalities.

Our net sales of CRM products increased $315 million, or 18.5 percent, in 2021, as compared to 2020.

Operational net sales growth included organic net sales growth of 7.7 percent in 2021 and the positive impact of 950 basis points from the acquisition of Preventice Solutions, adding to our CRM business a full portfolio of mobile cardiac health solutions and services, ranging from ambulatory cardiac monitors, to cardiac event monitors and mobile cardiac telemetry.

Organic sales growth was attributable to our defibrillator and pacemaker franchises, due to the recovery of semi-emergent and emergent procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales, as well as our cardiac diagnostics franchise, led by our ICM system.

Electrophysiology

Our Electrophysiology business develops and manufactures less-invasive medical technologies used in the diagnosis and treatment of rate and rhythm disorders of the heart.

basis points from foreign currency fluctuations, as compared to 2020.

Operational net sales growth was primarily driven by the recovery of elective procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales, as well as the success of our ongoing POLARx™ Cryoablation System and Stablepoint Force-Sensing Catheter international launches in Europe and Japan.

Operational net sales growth was primarily driven by our spinal cord stimulation (SCS) systems, led by our next generation WaveWriter Alpha™ SCS System and our deep brain stimulation (DBS) systems, including our Vercise Genus™ DBS System, due to the recovery of elective procedure volumes in the first half of 2021 compared to the prior year when the COVID-19 pandemic had a more significant negative impact on our net sales.

During the second half of 2021, procedure volumes continued to be negatively impacted by the COVID-19 pandemic due to their elective nature.

Operational net sales growth was driven by our WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device, our percutaneous coronary intervention guidance (PCIG) franchise, our complex PCI product offerings, and our drug-eluting stent (DES) systems due to the recovery of procedure volumes compared to the prior year when the COVID-19 pandemic had a significant negative impact on our net sales.

In addition, growth was positively impacted by $179 million in reserves recorded in the second half of 2020 primarily related to our conversion to a consignment inventory model for our LAAC franchise with the launch of our WATCHMAN FLX™ Device in the U.S. These increases were partially offset by the discontinuation of our LOTUS Edge™ Aortic Value System in the fourth quarter of 2020, general price declines associated with our DES systems and the unfavorable impact of China tender pricing on both DES systems and balloon catheter net sales following a reduction in prices in the first quarter of 2021.

In the third quarter of 2019, we completed the acquisition of BTG plc (BTG).

We integrated BTG's Interventional Medicine (IM) portfolio into our Peripheral Interventions division, adding complementary technologies in the areas of venous disease and interventional oncology.

Our net sales of Peripheral Interventions products of $1.820 billion represented 15 percent of our consolidated net sales in 2021.

We had currency derivative instruments outstanding in the contract amount of [removed: $8.381] [added: $7.324] billion as of December 31, [removed: 2021] [added: 2022] and [removed: $10.481] [added: $8.381] billion as of December 31, [removed: 2020.][added: 2021.]

A ten percent appreciation in the U.S. dollar’s value relative to the hedged currencies would increase the derivative instruments’ fair value by [removed: $298] [added: $208] million as of December 31, [removed: 2021 as] [added: 2022] compared to [removed: $333] [added: $298] million as of December 31, [removed: 2020.][added: 2021.]

A ten percent depreciation in the U.S. dollar’s value relative to the hedged currencies would decrease the derivative instruments’ fair value by [removed: $364] [added: $254] million as of December 31, [removed: 2021 as] [added: 2022] compared to [removed: $407] [added: $364] million as of December 31, [removed: 2020.][added: 2021.]

Any increase or decrease in the fair value of our currency exchange rate sensitive derivative instruments would be substantially offset by a corresponding decrease or increase in the fair value of the hedged underlying asset, liability or forecasted transaction, resulting in minimal impact on our [removed: consolidated statements of operations.][added: earnings.]

We had no interest rate derivative instruments outstanding as of December 31, [removed: 2021] [added: 2022] and December 31, [removed: 2020.][added: 2021.]

As of December 31, [removed: 2021, $9.121] [added: 2022, $8.986] billion in aggregate principal amount of our outstanding debt obligations were at fixed interest rates, representing approximately 100 percent of our total debt, on an amortized cost basis.

As of December 31, [removed: 2021,] [added: 2022,] our outstanding debt obligations at fixed interest rates were comprised of senior notes.

See *Note [removed: E] [added: D] – Hedging Activities and Fair Value Measurements* to our consolidated financial statements contained in Item 8.

We have audited the accompanying consolidated balance sheets of Boston Scientific Corporation (the Company) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] the related consolidated statements of operations, comprehensive income (loss), stockholders' equity and cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] and the related notes and financial statement schedule listed in the Index at Item 15(a) (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 23, [removed: 2022] [added: 2023] expressed an unqualified opinion thereon.

| As disclosed in Note B to the consolidated financial statements, during [removed: 2021,] [added: 2022,] the Company completed [removed: four acquisitions] [added: the acquisition of Baylis Medical Company Inc.] for [removed: total aggregate] [added: a] purchase price of [removed: $3.3] [added: $1.46] billion, net of cash acquired. The [removed: transactions were] [added: transaction was] accounted for as [removed: business combinations. In certain acquisitions, the Company has recognized] a [removed: liability for acquisition consideration that is contingent upon achieving either research and development, commercialization, or sales-based milestones. The Company determines the fair value of these contingent consideration arrangements, both as part of the initial purchase price allocation, and on an ongoing basis each reporting period until the arrangements are settled. As of December 31, 2021, the amount accrued for future estimated contingent consideration is $486 million, which represents a Level 3 estimate in the fair value hierarchy due to the significant unobservable inputs used in determining the fair value and the use of management judgment about the assumptions that market participants would use in pricing the liabilities.] [added: business combination.] Auditing the Company’s accounting for [removed: its acquisitions] [added: the acquisition] was complex due to the significant estimation required by management to determine the fair value of identified intangible assets, which totaled [removed: $1.2 billion] [added: $657 million] and principally consisted of developed [removed: technology, and to determine the fair value of contingent consideration arrangements.] [added: technology.] A significant emphasis is placed on the appropriateness of the estimates used by management to determine the fair value of acquired intangible assets due to the sensitivity of the respective fair values to the underlying assumptions. The Company used an income approach to measure the technology-related intangible assets. The significant assumptions used to estimate the value of the intangible assets included discount rates and certain assumptions that form the basis of the forecasted results, including revenue growth rates, estimates of technological obsolescence, operating profit margin and market participant synergies. [removed: The significance of the estimations used by management to determine the fair value of contingent consideration was primarily due to the sensitivity of the respective fair values to the underlying assumptions. The significant assumptions include estimation of the probability and timing of payment, future sales forecasts, as well as the appropriate discount rate based on the estimated timing of payments.] These significant assumptions are forward looking and could be affected by future economic and market conditions. | | | | | |

| *How We Addressed the Matter in Our Audit* | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s accounting for acquisitions. For example, we tested controls over the identification and valuation of intangible assets, including the valuation models and underlying assumptions used to develop such estimates. We [removed: also tested controls over the valuation of the contingent consideration liability, including the valuation models and underlying assumptions used to develop such estimates. For each of the Company's acquisitions, we] read the purchase [removed: agreements,] [added: agreement,] evaluated the significant assumptions and methods used in developing the fair value estimates, and tested the recognition of (1) the tangible assets acquired and liabilities assumed at fair value; (2) the identifiable intangible assets acquired at fair value; and (3) goodwill measured as a residual. To test the estimated fair value of the intangible assets, we performed audit procedures that included, among others, evaluating the Company's use of the income approach and testing the significant assumptions used in the model, as described above. [removed: In testing the valuation of contingent consideration, we assessed, among other things, the terms of the arrangements and the conditions that must be met for the amounts to become payable.] We evaluated the completeness and accuracy of the underlying data used in the analyses. For example, we compared the significant assumptions to current industry, market and economic trends, to the assumptions used to value similar assets in other acquisitions, to the historical results of the acquired business and to other guideline companies within the same industry. We involved our valuation professionals to assist with our evaluation of the methodology used by the Company and significant assumptions included in the fair value estimates. | | |

February 23, 2023

February 23, 2022

We [removed: operate pursuant to five strategic imperatives:] [added: aim to:] Strengthen Category Leadership, Expand into High Growth Adjacencies, Drive Global Expansion, Fund the Journey to Fuel Growth and Develop Key Capabilities.

We believe that our execution of these strategic imperatives will [added: help us deliver on our mission,] drive [removed: innovation, profitable revenue growth] [added: innovation] and increase [removed: stockholder] value [added: for our customers and employees,] while strengthening our leadership position in the medical device [removed: industry.][added: industry and delivering profitable revenue growth.]

[removed: Specifically, we are scaling our] [added: We continue to develop] digital [removed: capabilities] [added: tools and technologies that enable us] to [added: compete more effectively and] deliver first class [added: remote] physician education, drive deeper patient engagement and increase digitally-enabled sales force productivity.

This includes taking actions to combat discrimination and advancing equality and diversity, including through financial support of racial equity initiatives in the communities where we live and work, protecting the environment, investing in our employees' health and well-being, and many other initiatives that [added: we believe] ultimately help us create value responsibly.

Our core businesses are organized into [removed: three] [added: two] reportable segments: [removed: MedSurg, Rhythm and Neuro,] [added: MedSurg] and Cardiovascular.

Our Endoscopy business develops and manufactures devices to diagnose and treat a broad range of gastrointestinal [removed: (GI)] and pulmonary conditions with innovative, less invasive technologies.

- AXIOS™ Stents and Electrocautery Enhanced Delivery Systems, the first, and currently only stents [added: systems] in the U.S. indicated for endoscopic drainage of pancreatic pseudocysts,

- SpyGlass™ [added: DS II Direct Visualization Systems and SpyGlass™] Discover Digital Catheters, the first single-use scopes to enable physicians to take a single-stage approach to diagnostic and therapeutic procedures in the pancreaticobiliary system, including treating patients with bile duct stones,

- Acquire™ Endoscopic Ultrasound Fine Needle Biopsy Devices, which are designed to obtain larger tissue specimens for histological assessment and [removed: are useful when diagnosing] [added: diagnosis of] diseases such as pancreatic cancer, liver cancer and stomach [removed: lesions,][added: lesions and]

- our infection prevention portfolio, [removed: which includes a customizable Compliance EndoKit™ and single-use Orca™ Valves,] designed to minimize the risk of infection transmission and improve operational efficiencies by streamlining manual cleaning or eliminating the need for cleaning and tracking.

Our Urology [removed: and Pelvic Health] business develops and manufactures devices to treat various urological and pelvic conditions for both male and female anatomies, including kidney stones, benign prostatic hyperplasia (BPH), prostate cancer, erectile [removed: dysfunction, incontinence] [added: dysfunction] and [removed: pelvic floor disorders.][added: incontinence.]

- a comprehensive line of stone management products, including ureteral stents, catheters, baskets, guidewires, [removed: sheaths, balloons] [added: sheaths] and [removed: stone laser devices,][added: balloons,]

- our Prosthetic Urology portfolio, which includes [added: AMS 700™,] our penile implants to treat erectile dysfunction and [added: AMS 800™, our] urinary control systems to treat male urinary incontinence,

- [removed: BPH therapies, which include our] GreenLight XPS™ Laser System, MoXy™ Fiber, and Rezūm™ [removed: System,][added: Systems for treatment of BPH and]

- SpaceOAR™ Hydrogel Systems which help reduce side effects that men may experience after receiving radiotherapy to treat prostate cancer, [removed: and] [added: together with] our SpaceOAR [removed: Vue™] [added: VUE™] Hydrogel, providing clinicians with enhanced product [removed: visualization using computerized tomography (CT) scans instead of magnetic resonance imaging (MRI), and][added: visualization.]

[removed: Cardiac] [added: *Cardiac] Rhythm [removed: Management][added: Management*]

- [added: ACCOLADE™ family of] pacemakers and implantable cardiac resynchronization therapy pacemakers (CRT-P),

- LATITUDE™ Remote Patient Management Systems, which allow for more frequent monitoring and better guided treatment decisions by enabling physicians to monitor implantable system performance [removed: remotely and][added: remotely,]

- LUX-Dx™ Insertable Cardiac Monitor (ICM) systems, [removed: new,] long-term diagnostic devices implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and [removed: syncope.][added: syncope and]

[removed: In addition, in the first quarter of 2021, we completed the acquisition of Preventice Solutions, Inc., a privately-held company that offers] [added: - BodyGuardian™ remote cardiac monitoring systems provide] a full [removed: portfolio] [added: range] of mobile health solutions and remote monitoring services, ranging from ambulatory cardiac monitors – including short and long-term holter monitors – to cardiac event monitors and mobile cardiac [removed: telemetry, complementing our existing ICM offering.][added: telemetry.]

[removed: Our current generation of defibrillators,] [added: -] the RESONATE™ family of [removed: devices, include] [added: implantable cardioverter defibrillators (ICD) and implantable cardiac resynchronization therapy defibrillators (CRT-D), including] our proprietary HeartLogic™ Heart Failure (HF) Diagnostic and SmartCRT™ Technology with Multisite pacing in [removed: CRT-D.][added: CRT-D,]

[removed: We have] [added: Our entire transvenous defibrillator portfolio leverages our EnduraLife™ Battery Technology and has] magnetic resonance imaging (MRI) conditional labeling [removed: across our defibrillator portfolio around the world] when used with our current generation of [removed: leads, including our current generation devices as well as our prior generation of DYNAGEN™ and INOGEN™ devices.][added: leads.]

[removed: Our implantable defibrillator portfolio is complemented by our suite of] [added: -] ACUITY™ X4 Quadripolar LV Leads, RELIANCE™ family of ICD Leads and our INGEVITY™ Pacing [removed: Lead.][added: Leads,]

[removed: In addition to our transvenous defibrillator portfolio, we offer our] [added: -] EMBLEM™ MRI S-ICD System, [added: the world's first, and currently only, commercially available subcutaneous implantable cardiac defibrillators (S-ICD),] which provides physicians the ability to treat patients who are at risk for sudden cardiac arrest without touching the [removed: heart or invading the vasculature.][added: heart,]

[removed: Electrophysiology][added: *Electrophysiology*]

- IntellaMap [removed: OrionTM] [added: Orion™] Mapping Catheters, for use with our Rhythmia Mapping System to provide high-density, high-resolution maps of the heart,

- intracardiac ultrasound catheters, delivery sheaths and other [removed: accessories.][added: accessories]

- [removed: Precision™,] Precision [removed: Spectra™, Precision Montage™, Precision Novi™, Spectra WaveWriter™] [added: Montage™] and WaveWriter Alpha™ Spinal Cord Stimulator (SCS) Systems, designed to provide improved pain relief to a wide range of patients who suffer from chronic pain, [added: with proprietary features such as Multiple Independent Current Control, our Illumina 3D™ Proprietary Programming Software and FAST™ Therapy for profound parathesia-free pain relief in minutes, used by physicians to target specific areas of pain and customize stimulation of nerve fibers more precisely,]

- Superion™ Indirect Decompression Systems, minimally-invasive devices used to improve physical function and reduce pain in patients with moderate lumbar spinal stenosis [removed: (LSS) purchased as part of the acquisition of Vertiflex, Inc. in the second quarter of 2019,][added: (LSS).]

- our G4™ Generator and consumable portfolio in Radiofrequency Ablation (RFA) for pain management used by physicians to treat patients with chronic pain, [removed: and]

- [removed: Vercise™, Vercise™ PC,] Vercise Gevia™ and Vercise Genus™ Deep Brain Stimulation (DBS) Systems for the treatment of Parkinson's disease, tremor, and intractable primary and secondary dystonia, a neurological movement disorder characterized by involuntary muscle [removed: contractions.][added: contractions and]

[removed: Interventional Cardiology][added: *Interventional Cardiology Therapies (ICTx)*]

Our Interventional Cardiology [added: Therapies] business develops and manufactures technologies for diagnosing and treating coronary artery disease and [removed: structural heart] [added: aortic valve] conditions.

Our [removed: coronary stent] [added: product] offerings include the following:

- SYNERGY™, SYNERGY MEGATRON™ and SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent Systems, featuring an ultra-thin abluminal (outer) bioabsorbable polymer [removed: coating and][added: coating,]

Our [removed: PCI Guidance] [added: venous disease] product offerings include the following:

- AVVIGO™ Guidance Systems and AVVIGO™ Guidance System II, incorporating high-definition IVUS all in a mobile or integrated platform, [removed: and]

- iLab™ Ultrasound Imaging Systems with Polaris Software, designed to enhance the diagnosis and treatment of blocked vessels and other heart disorders, [removed: which are] compatible with our full line of imaging [removed: catheters and coronary physiology devices.][added: catheters,]

[removed: -] [added: Our] WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) [removed: Devices,] [added: Devices are] designed to close the left atrial appendage in patients with non-valvular atrial fibrillation who are at risk for ischemic [removed: stroke,][added: stroke.]

- Safari2™ Pre-Shaped Guidewires, intended to facilitate the introduction and placement of interventional devices within the heart, [removed: including those used with transcatheter aortic valve implantation or replacement procedures, and]

We operate pursuant to five strategic imperatives.

Urology

- Lumenis Pulse™ Holmium Laser Systems with MOSES™ Technology, complemented by a full line of laser fibers and accessories used in urology and otolaryngology procedures,

In the third quarter of 2022, we launched the Rezūm™ Water Vapor Therapy System in Japan following regulatory approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) and received approval of a new reimbursement category from Japan’s Central Social Insurance Medical Counsel (Chuikyo) for both the device and procedure.

In the first quarter of 2023, we received FDA clearance for and will begin a limited market release of our LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope system with the ability to monitor intrarenal pressure in real-time during ureteroscopy procedures.

- Our Cognita™ Practice Optimization suite of tools designed to increase awareness, streamline patient management, and sustain long-term outcomes for patients,

In 2022, we further expanded our portfolio with Image Guided Programming with the US release of Stimview™ XT, a proprietary DBS visualization software developed in collaboration with Brainlab AG, providing clinicians with real-time, 3D visualization and stimulation of brain anatomy.

Cardiology

- ROTAPRO™ Rotational Atherectomy Systems, which regulate the flow of air to the advancer, controlling burr rotation speed, and also monitor and display burr rotation speed and rotational atherectomy procedural time,

- ACURATE *neo2*™ Aortic Valve Systems for use in transcatheter aortic valve replacement (TAVR) procedures and

*Watchman*

- cardiac ablation catheters including the Blazer™, IntellaNav™, IntellaNav Stablepoint™ and IntellaTip MiFi Open-Irrigated Ablation Catheter families, featuring a unique Total Tip Cooling™ Design and DIRECTSENSE™ Software for monitoring radiofrequency (RF) energy delivery during procedures,

- Farapulse™ Pulsed Field Ablation (PFA) Systems for the treatment of atrial fibrillation (AF),

- POLARx™ Cryoablation Systems for the treatment of AF and

On February 14, 2022, we completed our acquisition of Baylis Medical Company, Inc (Baylis Medical), which has developed the radiofrequency (RF) NRG™ and VersaCross™ Transseptal Platforms as well as a family of guidewires, sheaths and dilators used to support left heart access, which expands our electrophysiology and structural heart product portfolios.

In the second quarter of 2022, we received FDA 510(k) clearance for and launched the VersaCross Connect™ LAAC Access Solution developed by Baylis Medical, providing safe and efficient access to the left side of the heart.

- EPIC™ and Innova™ Self-Expanding Stent Systems,

In the third quarter of 2022, we launched an ELUVIA™ line extension, introducing the longest-length available for treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery.

- WOLF Thrombectomy™ Platform, which is designed to mechanically remove the clots without damaging blood vessels, while also minimizing blood loss,

- EMBOLD™ Detachable Coil System, used for arterial and venous embolizations in the peripheral vasculature, and

- ICEFX™ and Visual ICE™ Cryoablation Systems for destruction of tissue, using image-guided needles to enable cryoablation visualization for optimal tumor coverage.

We hold patents worldwide that cover various aspects of our technology.

In Japan we are required to comply with Japan’s Ministry of Health, Labor and Welfare (MHLW) regulations.

In conjunction with the MHLW, the Pharmaceutical and Medical Device Agency is an independent agency that is responsible for reviewing drug and medical device applications and works with the MHLW to assess new product safety, develop comprehensive regulations, and monitor post-market safety.

Government and private sector initiatives related to limiting the

While we are making progress, our work is far from over.

We are committed to intentional action to drive meaningful change.

We listen to our employees and use that feedback to complement and expand our existing DE&I programs to emphasize initiatives aimed at developing our pipeline of talent and fostering a psychologically safe and inclusive workplace for all.

They provide forums for us to learn from

We have obtained ISO 45001:2018 Occupational Health and Safety Management System at eight of our key global locations.

This is a globally recognized standard for employee Occupational Health and Safety, established by the International Standards Organization, which provides a voluntary framework to identify key occupational health and safety aspects associated with our business helping to deliver continuous improvement.

As of December 31, 2022, we have achieved a safety level of 0.28 per 100 employees.

In addition to encouraging ongoing communication and feedback between employees and their

As evidence of our commitment to foster employee engagement, we include these metrics within the ESG scorecard that forms part of our Annual Bonus Plan.

The Boston Scientific Caring value guides us in the work we do each day including how we invest in the well-being of communities.

We work to advance possibilities in our three focus areas of health, STEM education and community.

Our efforts evolve frequently as do the pressing needs of our communities.

In 2022, we focused on supporting Ukrainian refugees, providing aid to those impacted by natural disasters and addressing the basic needs of underserved populations in communities where we live and work.

In February 2023, we provided donations to charitable organizations providing earthquake relief efforts in Türkiye and Syria, including overnight stays, meals, hygiene items and critical emergency supplies.

Many employees chose to support their communities through use of the Employee Matching Gifts program, which was doubled in 2022 on Giving Tuesday, the global day of giving that highlights the importance of supporting local communities around the world during the holiday season.

Our net sales have increased substantially since our formation, fueled in part by strategic acquisitions designed to improve our ability to take advantage of growth opportunities in the medical device industry and to build diversified portfolios within our core businesses.

We have also accelerated the development of digital tools and technologies to enable us to compete more effectively in the current healthcare environment, where our customers are looking for ways to improve outcomes and lower costs, and to make it easier to do business with Boston Scientific across multiple sites of care.

Our Enterprise Risk Management program analyzes the key risks inherent to achieving our strategic and organizational imperatives.

Our ongoing risk assessment helps us to anticipate and adapt to potential challenges to preserve and grow stockholder value.

Our Board of Directors oversees our risk management program and focuses on monitoring, and, together with management, mitigating the most significant risks facing the Company, including strategic, operational, reputational, financial, legal and compliance risks.

*Gastroenterology and Pulmonary*

- SpyGlass™ DS II Direct Visualization Systems, which bring digital imaging, a wider field of view and a simpler set-up (compared to our legacy SpyGlass System), thus enabling cholangioscopy to play a greater role in the diagnosis and treatment of pancreatico-biliary diseases,

- EXALT™ Model B Single-Use Bronchoscopes for use in a wide range of bronchoscopy procedures in the intensive care unit (ICU) and operating room (OR), such as secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal tube placement and biopsies,

- our endoluminal surgery portfolio featuring ORISE™ Gel and ORISE™ ProKnife, designed to be used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or other endoscopic device, and

During 2021, we launched our next-generation Resolution 360™ ULTRA Clip, featuring increased jaw length, thickness and volume capacity, and currently the largest through-the-scope hemostasis clip on the market, designed to approximate greater amount of tissue and facilitate stronger closing strength.

Urology and Pelvic Health

- our Pelvic Floor portfolio, which includes a comprehensive offering of female stress urinary incontinence solutions, including our innovative Solyx™ Single-Incision Sling System.

In the third quarter of 2021, we completed the acquisition of the global surgical business of Lumenis LTD (Lumenis), a privately-held company that develops and commercializes energy-based medical solutions, including innovative laser systems, fibers and accessories used for urology and otolaryngology procedures.

Rhythm and Neuro

- implantable cardioverter defibrillators (ICD) and implantable cardiac resynchronization therapy defibrillators (CRT-D) as well as the world's first, and currently only, commercially available subcutaneous implantable cardiac defibrillators (S-ICD),

Our entire transvenous defibrillator portfolio leverages our EnduraLife™ Battery Technology, including our extended longevity ICD, our CRT-D’s and our smallest and thinnest MINI ICD.

Our EMBLEM S-ICD devices have MRI conditional labeling and LATITUDE Remote Patient Management in most major markets.

We market our ACCOLADE™ family of pacemaker systems in nearly all major markets around the world.

Approval of our ACCOLADE Pacemaker family in the U.S., Europe and Japan also included approval for use of these products in patients undergoing MRI scans.

Much like our defibrillator portfolio, our pacemakers leverage our INGEVITY Pacing Leads and LATITUDE™ Remote Patient Management in nearly all major markets.

- Blazer™ Therapeutic Ablation Catheters,

- our broad portfolio of diagnostic catheters including Blazer™ Dx-20, Dynamic Tip™ and Viking™ Catheters,

- POLARxTM Cryoablation single shot ablation systems, and

Our cooled ablation catheter portfolio includes our U.S. and CE Mark approved Blazer™ Open-Irrigated, IntellaNav™ Open-Irrigated, and IntellaNav MiFi™ Open-Irrigated ablation catheters with a unique Total Tip Cooling™ Design.

We also offer our IntellaNav XP and IntellaNav MiFi XP solid tip catheters, as well as the CE Mark and Japanese Pharmaceuticals and Medical Device Agency (PMDA) approved IntellaNav STABLEPOINTTM Ablation Catheter.

Certain of our IntellaNav Catheters include MicroFidelity (MiFi) sensor technology in the catheter tip, and all are designed to allow magnetic tracking when used with our Rhythmia Mapping System.

Additionally, all major markets have access to our DIRECTSENSE™ Software, a tool for monitoring radiofrequency (RF) energy delivery during cardiac ablation procedures, providing meaningful information on tissue to catheter tip proximity, catheter stability, and other local tissue characteristics.

In the second half of 2021, we received Japanese PMDA approval and commenced the Japanese launch of our POLARxTM Cryoablation Single-shot Pulmonary Vein Isolation Technology.

During 2021, we completed enrollment in the FROZEN-AF investigational device exemption (IDE) study for POLARxTM.

In addition, in the third quarter of 2021, we completed the acquisition of Farapulse, Inc. (Farapulse), a privately-held company that has developed a Pulsed Field Ablation (PFA) System - a non-thermal single-shot ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias.

Farapulse became the first company to commercialize a cardiac PFA technology after receiving CE Mark in Europe in the first quarter of 2021.

Our Spectra WaveWriter™ SCS System is the first system approved by the FDA to simultaneously provide paresthesia-based and sub-perception therapy.

The Precision Spectra SCS System is the world's first and only SCS system with 32 contacts and 32 dedicated power sources.

We believe that we continue to have a technological advantage due to our proprietary features such as Multiple Independent Current Control and our Illumina 3D™ Proprietary Programming Software, which together are intended to allow the physician to target specific areas of pain and customize stimulation of nerve fibers more precisely.

We announced the European launch of the WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System in the third quarter of 2020 and received FDA approval in the fourth quarter of 2020 and followed with U.S. launch, indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with failed back surgery syndrome and complex regional pain syndrome.

In the third quarter of 2020, we received CE Mark and initiated a limited market release of the fourth generation Vercise Genus™ DBS System in Europe, and launched in the U.S in the first quarter of 2021, following FDA approval.

In Europe, we also market the GUIDE™ XT System, the first DBS visualization system built for directionality that utilizes patient specific anatomy and stimulation field modeling.

This technology provides physicians with 3-D image planning capability and when used in conjunction with the Vercise DBS Systems, enables physicians to personalize and optimize DBS treatment.

Our broad, innovative product offerings have led to our leadership in the global interventional cardiology market.

*Drug-Eluting Coronary Stent Systems*

See *Note [removed: K] [added: I] – Commitments and Contingencies* to our consolidated financial statements included in Item 8.

For the fiscal year ended December 31, [removed: 2021][added: 2022]

The aggregate market value of the registrant’s common stock held by non-affiliates was approximately [removed: $60.6] [added: $53.2] billion based on the last reported sale price of [removed: $42.76] [added: $37.27] of the registrant’s common stock on the New York Stock Exchange on June 30, [removed: 2021,] [added: 2022,] the last business day of the registrant’s most recently completed second fiscal quarter.

The number of shares outstanding of Common Stock, $0.01 par value per share, as of January 31, [removed: 2022] [added: 2023] was [removed: 1,426,724,712.][added: 1,434,780,104.]

Portions of the registrant’s definitive proxy statement to be filed within 120 days of December 31, [removed: 2021] [added: 2022] with the Securities and Exchange Commission in connection with its [removed: 2022] [added: 2023] Annual Meeting of Stockholders are incorporated by reference into Part III of this Form 10-K.

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| [ITEM [removed: 13.](#i4513a36fb1aa4e44acd87206b0aed737_178)] [added: 13.](#i0700a8f6ea1f4171b75e8081068a452b_190)] | | | [CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR [removed: INDEPENDENCE](#i4513a36fb1aa4e44acd87206b0aed737_178)] [added: INDEPENDENCE](#i0700a8f6ea1f4171b75e8081068a452b_190)] | | | [removed: [135](#i4513a36fb1aa4e44acd87206b0aed737_178)] [added: [125](#i0700a8f6ea1f4171b75e8081068a452b_190)] | | |

| [ITEM [removed: 14.](#i4513a36fb1aa4e44acd87206b0aed737_181)] [added: 14.](#i0700a8f6ea1f4171b75e8081068a452b_193)] | | | [PRINCIPAL ACCOUNTANT FEES AND [removed: SERVICES](#i4513a36fb1aa4e44acd87206b0aed737_181)] [added: SERVICES](#i0700a8f6ea1f4171b75e8081068a452b_193)] | | | [removed: [135](#i4513a36fb1aa4e44acd87206b0aed737_181)] [added: [125](#i0700a8f6ea1f4171b75e8081068a452b_193)] | | |

| [ITEM [removed: 15.](#i4513a36fb1aa4e44acd87206b0aed737_187)] [added: 15.](#i0700a8f6ea1f4171b75e8081068a452b_199)] | | | [EXHIBITS AND FINANCIAL STATEMENT [removed: SCHEDULES](#i4513a36fb1aa4e44acd87206b0aed737_187)] [added: SCHEDULES](#i0700a8f6ea1f4171b75e8081068a452b_199)] | | | [removed: [136](#i4513a36fb1aa4e44acd87206b0aed737_187)] [added: [126](#i0700a8f6ea1f4171b75e8081068a452b_199)] | | |

| [ITEM [removed: 16.](#i4513a36fb1aa4e44acd87206b0aed737_190)] [added: 16.](#i0700a8f6ea1f4171b75e8081068a452b_202)] | | | [FORM 10-K [removed: SUMMARY](#i4513a36fb1aa4e44acd87206b0aed737_190)] [added: SUMMARY](#i0700a8f6ea1f4171b75e8081068a452b_202)] | | | [removed: [148](#i4513a36fb1aa4e44acd87206b0aed737_190)] [added: [135](#i0700a8f6ea1f4171b75e8081068a452b_202)] | | |

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

| [PART I](#i0700a8f6ea1f4171b75e8081068a452b_13) | | | | | | [3](#i0700a8f6ea1f4171b75e8081068a452b_13) | | |

| [PART II](#i0700a8f6ea1f4171b75e8081068a452b_34) | | | | | | [33](#i0700a8f6ea1f4171b75e8081068a452b_34) | | |

| [PART III](#i0700a8f6ea1f4171b75e8081068a452b_178) | | | | | | [125](#i0700a8f6ea1f4171b75e8081068a452b_178) | | |

| [PART IV](#i0700a8f6ea1f4171b75e8081068a452b_196) | | | | | | [126](#i0700a8f6ea1f4171b75e8081068a452b_196) | | |

| [SIGNATURES](#i0700a8f6ea1f4171b75e8081068a452b_205) | | | | | | [136](#i0700a8f6ea1f4171b75e8081068a452b_205) | | |

| [PART I](#i4513a36fb1aa4e44acd87206b0aed737_13) | | | | | | [3](#i4513a36fb1aa4e44acd87206b0aed737_13) | | |

| [PART II](#i4513a36fb1aa4e44acd87206b0aed737_34) | | | | | | [37](#i4513a36fb1aa4e44acd87206b0aed737_34) | | |

| [PART III](#i4513a36fb1aa4e44acd87206b0aed737_166) | | | | | | [135](#i4513a36fb1aa4e44acd87206b0aed737_166) | | |

| [PART IV](#i4513a36fb1aa4e44acd87206b0aed737_184) | | | | | | [136](#i4513a36fb1aa4e44acd87206b0aed737_184) | | |

| [SIGNATURES](#i4513a36fb1aa4e44acd87206b0aed737_193) | | | | | | [149](#i4513a36fb1aa4e44acd87206b0aed737_193) | | |

As of December 31, [removed: 2021,] [added: 2022,] we maintained [removed: 16] [added: 15] principal manufacturing facilities, including eight in the U.S. and Puerto Rico, three in Ireland, two in Costa Rica, one in Malaysia, [removed: one in Brazil] and one in [removed: Switzerland,] [added: Brazil,] as well as various distribution and technology centers around the world.

Our products are distributed worldwide from primary customer fulfillment centers in Massachusetts, the Netherlands, [added: Malaysia] and Japan.

The following is a summary of our facilities as of December 31, [removed: 2021] [added: 2022] (in approximate square feet):

(1) Includes our principal manufacturing facilities in Minnesota, Ireland, Puerto Rico and [removed: one facility in] [added: Coyol,] Costa Rica, our manufacturing facility in Malaysia, our primary customer fulfillment centers in Massachusetts, the [removed: Netherlands] [added: Netherlands, Malaysia] and Japan, [removed: and] [added: as well as] our global headquarters [removed: location] [added: located] in Marlborough, Massachusetts.

(2) Includes our principal manufacturing facilities in California, Indiana, [removed: Brazil, Switzerland] [added: Brazil] and [removed: one in] [added: Heredia,] Costa Rica, [removed: and] [added: as well as] our regional headquarters located in Singapore and Voisins-le-Bretonneux, France.

| U.S. | | | 4,043,041 | | | | | | 1,038,419 | | | | | | 5,081,460 | | |

| International | | | 2,424,123 | | | | | | 2,026,634 | | | | | | 4,450,757 | | |

| | | | 6,467,164 | | | | | | 3,065,053 | | | | | | 9,532,217 | | |

| U.S. | | | 4,043,041 | | | | | | 1,257,706 | | | | | | 5,300,747 | | |

| International | | | 2,200,042 | | | | | | 1,916,968 | | | | | | 4,117,010 | | |

| | | | 6,243,083 | | | | | | 3,174,674 | | | | | | 9,417,757 | | |

As of January 31, [removed: 2022,] [added: 2023,] there were [removed: 6,226] [added: 5,752] holders of record of our common stock.

We did not pay a cash dividend in [removed: 2021, 2020] [added: 2022, 2021] or [removed: 2019] [added: 2020] on our common stock and currently we do not intend to pay cash dividends on our common stock.

We made no share repurchases in [added: 2022 or] 2021 and, as of December 31, [removed: 2021,] [added: 2022,] had the full $1.000 billion remaining available under the 2020 [removed: share repurchase program.][added: Share Repurchase Program.]

Refer to Note [removed: L] [added: J] – Stockholders' Equity to our consolidated financial statements contained in Item 8.

There were no purchases of equity securities by the issuer or affiliated purchases in the fourth quarter of [removed: 2021,] [added: 2022,] required to be reported here.

The graph assumes $100 was invested in our common stock and in each of the named indices on December 31, [removed: 2016] [added: 2017] and that any dividends were reinvested.

[removed: ][added: ]

On January 25, 2013, our Board of Directors approved, and on January 29, 2013, we announced, a program authorizing the repurchase of up to $1.000 billion of our common stock (2013 share repurchase program).

In 2020, we repurchased approximately $535 million or 15.7 million shares of our common stock under the 2013 share repurchase program, which represented the full amount remaining under that authorization.

| *(in millions, except per share data)* | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Net sales | | | $ | [removed: 11,888] [added: 12,682] | | | | | $ | [removed: 9,913] [added: 11,888] | | | | | $ | [removed: 10,735] [added: 9,913] | |

| Cost of products sold | | | [removed: 3,711] [added: 3,956] | | | | | | [removed: 3,465] [added: 3,711] | | | | | | [removed: 3,116] [added: 3,465] | | |

| Gross profit | | | [removed: 8,177] [added: 8,727] | | | | | | [removed: 6,448] [added: 8,177] | | | | | | [removed: 7,620] [added: 6,448] | | |

| Selling, general and administrative expenses | | | [removed: 4,359] [added: 4,520] | | | | | | [removed: 3,787] [added: 4,359] | | | | | | [removed: 3,941] [added: 3,787] | | |

| Research and development expenses | | | [removed: 1,204] [added: 1,323] | | | | | | [removed: 1,143] [added: 1,204] | | | | | | [removed: 1,174] [added: 1,143] | | |

| Royalty expense | | | [removed: 49] [added: 47] | | | | | | [removed: 45] [added: 49] | | | | | | [removed: 65] [added: 45] | | |

| Amortization expense | | | [removed: 741] [added: 803] | | | | | | [removed: 789] [added: 741] | | | | | | [removed: 699] [added: 789] | | |

| Goodwill impairment charges | | | — | | | | | | [removed: 73] [added: —] | | | | | | [removed: —] [added: 73] | | |

| Intangible asset impairment charges | | | [removed: 370] [added: 132] | | | | | | [removed: 460] [added: 370] | | | | | | [removed: 105] [added: 460] | | |

| Contingent consideration net expense (benefit) | | | [removed: (136)] [added: 35] | | | | | | [removed: (100)] [added: (136)] | | | | | | [removed: (35)] [added: (100)] | | |

| Restructuring net charges (credits) | | | [removed: 40] [added: 24] | | | | | | [removed: 52] [added: 40] | | | | | | [removed: 38] [added: 52] | | |

| Litigation-related net charges (credits) | | | [removed: 430] [added: 173] | | | | | | [removed: 278] [added: 430] | | | | | | [removed: 115] [added: 278] | | |

| [removed: Gains] [added: Loss (gain)] on disposal of businesses and assets | | | [removed: (78)] [added: 22] | | | | | | [removed: —] [added: (78)] | | | | | | — | | |

| | | | [removed: 6,978] [added: 7,078] | | | | | | [removed: 6,528] [added: 6,978] | | | | | | [removed: 6,102] [added: 6,528] | | |

| Operating income (loss) | | | [removed: 1,199] [added: 1,649] | | | | | | [removed: (80)] [added: 1,199] | | | | | | [removed: 1,518] [added: (80)] | | |

| Interest expense | | | [removed: (341)] [added: (470)] | | | | | | [removed: (361)] [added: (341)] | | | | | | [removed: (473)] [added: (361)] | | |

| Other, net | | | [removed: 218] [added: (38)] | | | | | | [removed: 362] [added: 218] | | | | | | [removed: (358)] [added: 362] | | |

| Income (loss) before income taxes | | | [removed: 1,076] [added: 1,141] | | | | | | [removed: (79)] [added: 1,076] | | | | | | [removed: 687] [added: (79)] | | |

| Income tax (benefit) expense | | | [removed: 36] [added: (32)] | | | | | | [removed: 2] [added: (29)] | | | | | | [removed: (4,013)] [added: (28)] | | |

| Net income (loss) | | | [removed: 1,041] [added: 698] | | | | | | [removed: (82)] [added: 1,041] | | | | | | [removed: 4,700] [added: (82)] | | |

| Preferred stock dividends | | | (55) | | | | | | [removed: (33)] [added: (55)] | | | | | | [removed: —] [added: (33)] | | |

| Net income (loss) available to common stockholders | | | $ | [removed: 985] [added: 642] | | | | | $ | [removed: (115)] [added: 985] | | | | | $ | [removed: 4,700] [added: (115)] | |

| Net income (loss) per common share — basic | | | $ | [removed: 0.69] [added: 0.45] | | | | | $ | [removed: (0.08)] [added: 0.69] | | | | | $ | [removed: 3.38] [added: (0.08)] | |

| Net income (loss) per common share — assuming dilution | | | $ | [removed: 0.69] [added: 0.45] | | | | | $ | [removed: (0.08)] [added: 0.69] | | | | | $ | [removed: 3.33] [added: (0.08)] | |

| Basic | | | [removed: 1,422.3] [added: 1,430.5] | | | | | | [removed: 1,416.7] [added: 1,422.3] | | | | | | [removed: 1,391.5] [added: 1,416.7] | | |

| Assuming dilution | | | [removed: 1,433.8] [added: 1,439.7] | | | | | | [removed: 1,416.7] [added: 1,433.8] | | | | | | [removed: 1,410.6] [added: 1,416.7] | | |

| *(in millions)* | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Net income (loss) | | | $ | [removed: 1,041] [added: 698] | | | | | $ | [removed: (82)] [added: 1,041] | | | | | $ | [removed: 4,700] [added: (82)] | |

| Foreign currency translation adjustment | | | [removed: (125)] [added: (94)] | | | | | | [removed: 76] [added: (125)] | | | | | | [removed: 195] [added: 76] | | |

| Net change in derivative financial instruments | | | [removed: 170] [added: 63] | | | | | | [removed: (137)] [added: 170] | | | | | | [removed: 62] [added: (137)] | | |

| Net change in defined benefit pensions and other items | | | [removed: 11] [added: 37] | | | | | | [removed: (1)] [added: 11] | | | | | | [removed: (20)] [added: (1)] | | |

| Total other comprehensive income (loss) | | | [removed: 56] [added: 6] | | | | | | [removed: (63)] [added: 56] | | | | | | [removed: 237] [added: (63)] | | |

| Total comprehensive income (loss) | | | $ | [removed: 1,096] [added: 704] | | | | | $ | [removed: (145)] [added: 1,096] | | | | | $ | [removed: 4,937] [added: (145)] | |

| *(in millions, except share and per share data)* | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| [removed: Cash] [added: *Cash] and cash [removed: equivalents] [added: equivalents*] | | | $ | [added: 928 | | | | | $ |] 1,925 | | | | | $ | 1,734 | |

| Trade accounts receivable, net | | | [removed: 1,778] [added: 1,970] | | | | | | [removed: 1,531] [added: 1,778] | | |

| Inventories | | | [removed: 1,610] [added: 1,867] | | | | | | [removed: 1,351] [added: 1,610] | | |

| Prepaid income taxes | | | [removed: 205] [added: 264] | | | | | | [removed: 194] [added: 205] | | |

| Other current assets | | | [removed: 799] [added: 731] | | | | | | [removed: 751] [added: 799] | | |

| Net income (loss) | | | $ | 698 | | | | | $ | 1,041 | | | | | $ | (82) | |

| Debt extinguishment costs | | | 194 | | | | | | — | | | | | | — | | |

| Cash, cash equivalents, restricted cash and restricted cash equivalents at end of period | | | $ | 1,126 | | | | | $ | 2,168 | | | | | $ | 1,995 | |

The primary basis for determining the technological

In addition, we classify internal use software as an intangible asset within our accompanying consolidated balance sheets, and amortize over a two to 15 year useful life.

Due to the operational nature of these assets, we record the amortization of our internal use software within *Cost of products sold; Selling, general and administrative expenses* and *Research and development expenses,* as appropriate within our accompanying consolidated statements of operations, and include in *Amortization expense* only that associated with intangible assets acquired in a business combination or asset acquisition, as well as internally-developed patents.

We

Further, transaction costs were immaterial to our consolidated financial statements and were expensed as incurred.

On June 15, 2022, we announced our entry into a definitive agreement with Synergy Innovation Co, Ltd, to purchase its majority stake of M.I. Tech Co., Ltd., (M.I. Tech), a publicly traded Korean manufacturer and distributor of medical devices for endoscopic and urological procedures.

The agreement, whereby we will purchase approximately 64 percent of the outstanding shares of M.I. Tech, consists of an upfront purchase price of KRW 291.2 billion or approximately $230 million at foreign currency exchange rates locked into at the time of the agreement via forward currency contracts.

We are working towards closing the acquisition during the second quarter of 2023, subject to customary regulatory approvals.

The M.I. Tech stent portfolio complements our existing Endoscopy portfolio which will provide physicians with more treatment options to meet specific patient needs.

On November 29, 2022, we announced our entry into a definitive agreement to acquire 100 percent of the outstanding equity of Apollo Endosurgery, Inc. (Apollo), a public company which offers a portfolio of devices used during endoluminal procedures to close gastrointestinal defects, manage gastrointestinal complications and aid in weight loss for patients suffering from obesity.

The agreement provides for an upfront cash payment of $10.00 per share, approximately $615 million, and is expected to close during the first half of 2023, subject to customary closing conditions.

On February 20, 2023, we completed the acquisition of a majority stake in Acotec Scientific Holdings Limited (Acotec), a publicly traded Chinese manufacturer of drug-coated balloons used in the treatment of vascular and other diseases.

We acquired approximately 65 percent of the outstanding shares of Acotec, for an upfront cash payment of HK$20.00 per share, or approximately $520 million at foreign currency exchange rates as of closing using cash on hand.

The Acotec portfolio complements our existing Peripheral Interventions portfolio and will strengthen our presence in China.

We are integrating the Baylis Medical business into our Cardiology division.

| | | | $ | 1,463 | | | | | | | | | | | | | | | | |

| *(in millions)* | | | | | | | | | | | | | | | | | | | | | | | |

| | | | $ | 1,463 | | | | | | | | | | | | | | | | | | | |

| Technology-related | | | $ | 622 | | | | | 11 | | | | | | 11% | | | | | | | | |

| | | | $ | 657 | | | | | | | | | | | | | | | | | | | |

We have made combined milestone and revenue based payments of $114 million to date.

In 2022, we recorded certain measurement period adjustments primarily related to our prior year acquisition of the surgical business of Lumenis.

We recorded an accrued income tax liability within *Other non-current liabilities* within our consolidated balance sheet of $183 million related to uncertain tax positions assumed in connection with the acquisition.

We expect to be indemnified for the majority of such tax obligations and we recognized a corresponding indemnification asset of $177 million within *Other non-current assets* within our consolidated balance sheets.

Interest and penalties accrued on the tax liability are being recorded within *Income tax expense (benefit)* and corresponding adjustments to the indemnification asset are being recorded in *Other, net* within our accompanying consolidated statements of operations.

The outcome of these matters is subject to uncertainty and ultimately, the amount of tax due and the related indemnification reimbursement we receive will be dependent on the outcome of tax return examinations by relevant authorities.

Refer to Note *Note G – Supplemental Balance Sheet Information* for further details regarding our indemnification asset.

| IPR&D | | | 69 | | | | | | N/A | | | | | | 12% | | | | | | | | |

| IPR&D | | | 43 | | | | | | N/A | | | | | | 17% | | | | | | | | |

| Contingent consideration net expense (benefit) | | | 35 | | |

| Balance as of December 31, 2022 | | | $ | 149 | |

The payments made during 2022 were primarily related to our 2021 acquisitions of Farapulse and Preventice.

The net expense of $35 million recorded in 2022 related to an increase in expected revenue-based payments as a result of over-achievement of net sales performance, primarily related to Farapulse.

| Probability of Payment | | | 10% | | | \- | | | 25% | | | 22% | | | | | | | | | | | |

| *(in millions)* | | | 2022 | | | | | | 2021 | | |

| | | | $ | 407 | | | | | $ | 412 | |

The increase in our balance of goodwill and amortizable intangible assets is related primarily to our acquisition of Baylis Medical completed in the first quarter of 2022.

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

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

| Assets held for sale | | | — | | | | | | 1,133 | | |

| Defined benefit pensions and other items | | | 11 | | | | | | (1) | | | | | | (20) | | |

impairment, or more frequently if impairment indicators are present or changes in circumstances suggest an impairment may exist.

for tax on Global Intangible Low Taxed Income (GILTI) earned by certain foreign subsidiaries.

See *Note H – Restructuring-related Activities* for further information and discussion of our restructuring plans.

Shipping and Handling Costs

We generally do not bill customers for shipping and handling of our products.

We treat shipping costs incurred after a customer obtains control of the good as a fulfillment cost and record in *Selling, general and administrative expenses* within our consolidated statements of operations.

Shipping costs were $194 million in 2021, $146 million in 2020 and $144 million in 2019.

We completed four acquisitions and one divestiture in 2021 and did not complete any material acquisitions during 2020.

We plan to integrate the Baylis Medical business into our Electrophysiology division, supported by our structural heart sales force.

*Purchase Price Allocation*

The final determination of the fair value of certain assets and liabilities will be completed within the measurement period in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 805, *Business Combinations*.

| In-process research and development (IPR&D) | | | 43 | | | | | | N/A | | | | | | 17% | | | | | | | | |

The agreement included the transfer of five facilities and approximately 280 employees globally.

We classified the assets and liabilities of the Specialty Pharmaceuticals business (disposal group) as held for sale within our consolidated balance sheet as of December 31, 2020 at their respective carrying values, which approximated fair value, less costs to sell.

Assets within the disposal group are presented within *Assets held for sale* and liabilities are presented within *Other current liabilities* within our consolidated balance sheet as of December 31, 2020.

2019 Acquisitions

BTG plc

On August 19, 2019, we completed our acquisition of BTG plc (BTG), a public company organized under the laws of England and Wales.

BTG had three key portfolios, the largest of which is its interventional medicine portfolio (Interventional Medicine) that encompasses interventional oncology therapeutic technologies for patients with liver and kidney cancers, as well as a vascular portfolio for treatment of deep vein thrombosis, pulmonary embolism, deep venous obstruction and superficial venous disease.

Following the closing of the acquisition, we integrated BTG's Interventional Medicine business into our Peripheral Interventions division.

In addition to the Interventional Medicine product lines, the BTG portfolio also included the Specialty Pharmaceuticals business, comprised of acute care antidotes to treat overexposure to certain medications and toxins.

On March 1, 2021, we completed the divestiture of Specialty Pharmaceuticals for a purchase price of approximately $800 million.

The BTG portfolio further included a licensing portfolio (Licensing arrangements) that generated net royalties related to BTG intellectual property and product license agreements.

In connection with the acquisition, we acquired rights to future royalties associated with the Zytiga™ Drug used to treat certain forms of prostate cancer.

In the fourth quarter of 2019, we sold our rights to these royalties for $256 million in cash, included in *Proceeds from royalty rights transfer* in our consolidated statements of cash flows.

The transaction price for the acquisition of BTG consisted of upfront cash in the aggregate amount of £3.312 billion (or $4.023 billion based on the exchange rate at closing on August 19, 2019) for the entire issued ordinary share capital of BTG, whereby BTG stockholders received 840 pence (or $10.20 based on the exchange rate at closing) in cash for each BTG share.

The transaction price included $404 million of cash and cash equivalents acquired.

We implemented our acquisition of BTG by way of a court-sanctioned scheme of arrangement under Part 26 of the United Kingdom Companies Act 2006, as amended.

We accounted for the acquisition of BTG as a business combination, and in accordance with FASB ASC Topic 805*, Business Combinations*, (FASB ASC Topic 805), we recorded the assets acquired and liabilities assumed at their respective fair values as of the acquisition date.

| | | | | | |

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

| Goodwill | | | $ | 1,635 | |

| Inventories | | | 232 | | |

| Accrued expenses and other current liabilities | | | (308) | | |

| | | | $ | 3,619 | |

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

Our management, with the participation of our Chief Executive Officer (CEO) and Executive Vice President and Chief Financial Officer (CFO), evaluated the effectiveness of our disclosure controls and procedures as of December 31, [removed: 2021] [added: 2022] pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended.

Based on their evaluation, our CEO and CFO concluded that as of December 31, [removed: 2021,] [added: 2022,] our disclosure controls and procedures were effective.

During the quarter ended December 31, [removed: 2021,] [added: 2022,] there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

During 2022, we [removed: will begin] [added: began] a multi-year implementation of a new global enterprise resource planning (ERP) system, which will replace our existing system.

Further, while many of our employees worked remotely to adhere to COVID-19 social distancing requirements, this did not affect our ability to maintain financial reporting systems, internal controls over financial reporting or disclosure controls and procedures.

Prior to the COVID-19 pandemic, we were leveraging electronic tools to facilitate our global close process and to connect our physically dispersed team of finance professionals in offices around the world.

While the quarterly close cycle was performed remotely, fundamentally, the work performed, and the processes and controls executed did not change.

2023 Restructuring Plan

On February 22, 2023, our Board of Directors approved, and we committed to, a new global restructuring program (the 2023 Restructuring Plan).

The 2023 Restructuring Plan is intended to meet evolving global market demands and conditions by ensuring that we are structured and resourced to support our strategic imperatives and deliver sustainable value.

The 2023 Restructuring Plan will further build on our Global Supply Chain Optimization strategy, which is intended to simplify our manufacturing and distribution network by transferring certain production lines among facilities and expand operational efficiencies and resiliency.

Key activities under the 2023 Restructuring Plan will also include optimizing certain functional capabilities to better support business growth and achieve cost synergies.

These activities are expected to be initiated in the first quarter of 2023, and substantially completed by the end of 2025.

While we expect limited role reductions as a result of these restructuring activities, we anticipate that our overall employee base will remain relatively unchanged upon completion of the 2023 Restructuring Plan as new jobs are created in areas of growth and resources are deployed to support an expanding portfolio and growing global market needs.

The implementation of the 2023 Restructuring Plan is estimated to result in total pre-tax charges of approximately $450 million to $550 million, of which approximately $350 million to $450 million is expected to result in future cash outlays.

The following table provides a summary of our estimates of total pre-tax charges associated with the 2023 Restructuring Plan by major type of cost:

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

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

| Type of Cost (in millions) | | | Total Estimated Amount Expected to be Incurred | | | | | | | | |

| Restructuring charges: | | | | | | | | | | | |

| Termination benefits(1) | | | $60 | | | \- | | | $80 | | |

| Other(2) | | | 40 | | | \- | | | 60 | | |

| Restructuring-related expenses: | | | | | | | | | | | |

| Transfer costs | | | 250 | | | | | | 280 | | |

| Other(3) | | | 100 | | | \- | | | 130 | | |

| | | | $450 | | | \- | | | $550 | | |

(1) Plans detailing specific employee impacts will be developed for each affected region and business, working with employee representative bodies where required under local laws.

(2) Consists primarily of consulting fees and costs associated with contractual cancellations.

(3) Comprised of other costs directly related to the restructuring program, including program management, accelerated depreciation, fixed asset write-offs, and costs to transfer product lines among facilities.

None.

The information required by this Item is set forth in our Proxy Statement for the [removed: 2022] [added: 2023] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2021] [added: 2022] and is incorporated into this Annual Report on Form 10-K by reference.

The information required by this Item is set forth in our Proxy Statement for the [removed: 2022] [added: 2023] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2021] [added: 2022] and is incorporated into this Annual Report on Form 10-K by reference.

The information required by this Item is set forth in our Proxy Statement for the [removed: 2022] [added: 2023] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2021] [added: 2022] and is incorporated into this Annual Report on Form 10-K by reference.

The information required by this Item is set forth in our Proxy Statement for the [removed: 2022] [added: 2023] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2021] [added: 2022] and is incorporated into this Annual Report on Form 10-K by reference.

The information required by this Item is set forth in our Proxy Statement for the [removed: 2022] [added: 2023] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2021] [added: 2022] and is incorporated into this Annual Report on Form 10-K by reference.

| [removed: 2.1] [added: 10.6] | | | | | | [removed: [Purchase] [added: [Settlement] Agreement among [removed: American Medical Systems Holdings, Inc., Endo Health Solutions Inc.] [added: Johnson & Johnson, Guidant LLC] and the Company, dated as of [removed: March 2,] [added: February 13,] 2015 (incorporated by reference to Exhibit [removed: 2.1,] [added: 10.1 to the Company's] Quarterly Report on Form 10-Q for the quarter ended March 30, 2015, [added: filed on May 6, 2015,] File No. [removed: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572515000012/exhibit21-amsagreement.htm)] [added: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572515000012/exhibit101-jjagreement.htm)] | | |

| 3.1 | | | | | | [Third Restated Certificate of Incorporation (incorporated herein by reference to Exhibit [removed: 3.2,] [added: 3.2 to the Company's] Annual Report on Form 10-K for the year ended December 31, 2007, [added: filed February 28, 2008,] File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000107261308000584/exhibit3-2_15759.txt) | | |

| 3.2 | | | | | | [Amended and Restated By-Laws of the Company (incorporated herein by reference to Exhibit [removed: 3.1,] [added: 3.1 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] May 15, 2019, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000110465919029732/a19-9977_1ex3d1.htm) | | |

| 3.3 | | | | | | [Certificate of Designations of [removed: the] 5.50% Mandatory Convertible Preferred Stock, Series A, filed with the Secretary of State of the State of Delaware on May 26, 2020 (incorporated herein by reference to Exhibit [removed: 3.1,] [added: 3.1 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] May [removed: 27,] [added: 28,] 2020, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000094787120000519/ss174270_ex0301.htm) | | |

| 4.1 | | | | | | Specimen Certificate for shares of the Company's Common Stock (incorporated herein by reference to Exhibit [removed: 4.1,] [added: 4.1 to the Company's] Registration [added: Statement on Form S-1. File] No. 33-46980). | | |

| [removed: 4.2*] [added: 4.2] | | | | | | [Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit42-descriptionofthe.htm)] [added: 1934 (incorporated herein by reference to Exhibit 4.2 to the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed on February 23, 2022, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572522000006/exhibit42-descriptionofthe.htm)] | | |

| 4.3 | | | | | | [Indenture dated as of June 25, 2004, between the Company and JPMorgan Chase Bank, as Trustee (incorporated herein by reference to Exhibit [removed: 4.1,] [added: 4.1 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] June 25, 2004, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000095013504003276/b509658kexv4w1.txt) | | |

| 4.4 | | | | | | [Indenture dated as of November 18, 2004, between the Company and J.P. Morgan Trust Company, National Association, as Trustee (incorporated herein by reference to Exhibit [removed: 4.1,] [added: 4.1 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] November 18, 2004, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000107261304002201/exh4-1_13106.txt) | | |

| 4.5 | | | | | | [First Supplemental Indenture dated as of April 21, 2006 [added: between the Company and J.P. Morgan Trust Company, National Association, as Trustee] (incorporated herein by reference to Exhibit [removed: 99.4,] [added: 99.4 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] April [removed: 21,] [added: 26,] 2006, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000110465906027974/a06-8189_4ex99d4.htm) | | |

| 4.6 | | | | | | [Second Supplemental Indenture dated as of April [removed: 21,] [added: 26,] 2006 [added: between the Company and The Bank of New York Mellon Trust Company, N.A., as successor to J.P. Morgan Trust Company, National Association, as Trustee] (incorporated herein by reference to Exhibit [removed: 99.6,] [added: 99.6 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] April [removed: 21,] [added: 26,] 2006, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000110465906027974/a06-8189_4ex99d6.htm) | | |

| 4.7 | | | | | | [Form of Global Security for the 6.25% Notes due 2035 in the aggregate principal amount of $350,000,000, and [removed: form of] Notice to [removed: holders] [added: Holders] thereof (incorporated herein by reference to Exhibit [removed: 4.2,] [added: 4.2 and Exhibit 99.7 to the Company's] Current [removed: Report] [added: Reports] on Form 8-K [removed: dated] [added: filed on] November 17, 2005 and [removed: Exhibit 99.7, Current Report on Form 8-K dated] April [removed: 21,] [added: 26,] 2006, [added: respectively,] File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000107261305002690/exh4-2_13988.htm) | | |

| 4.8 | | | | | | [Indenture dated as of June 1, 2006, between the Company and JPMorgan Chase Bank, N.A., as Trustee (incorporated herein by reference to Exhibit [removed: 4.1,] [added: 4.1 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] June 9, 2006, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000095013506003879/b61236bsexv4w1.txt) | | |

| 4.9 | | | | | | [7.375% Senior Note due January 15, 2040 in the aggregate principal amount of $300,000,000 (incorporated herein by reference to Exhibit [removed: 4.4,] [added: 4.4 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] December [removed: 10,] [added: 14,] 2009, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000095012309070623/b78468exv4w4.htm) | | |

| [removed: 4.10] [added: 4.13] | | | | | | [removed: [4.125%] [added: [Form of 3.750%] Senior Note [removed: Due October] [added: due March] 1, [removed: 2023] [added: 2026] in the aggregate [removed: principle] amount of [removed: $450,000,000] [added: $850,000,000] (incorporated herein by reference to Exhibit [removed: 4.3,] [added: 4.3 to the Company's] Current Report on Form 8-K [removed: dated August 8, 2013,] [added: filed on February 25, 2019,] File No. [removed: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000110465913063328/a13-18170_1ex4d3.htm)] [added: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572519000016/exhibit43-3750notesdue2026.htm)] | | |

| [removed: 4.11] [added: 4.22] | | | | | | [removed: [3.375%] [added: [Form of 1.375%] Senior [removed: Notes] [added: Note] due [removed: 2022] [added: March 8, 2028] (incorporated herein by reference to Exhibit [removed: 4.3,] [added: 4.3 to the Company's] Current Report on Form 8-K [removed: dated May 12, 2015,] [added: filed on March 8, 2022,] File No. [removed: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000110465915037235/a15-11340_1ex4d3.htm)] [added: 1-11083).](http://www.sec.gov/Archives/edgar/data/0000885725/000110465922031615/tm228612d1_ex4-3.htm)] | | |

| [removed: 4.12] [added: 4.18] | | | | | | [removed: [3.850%] [added: [Form of 1.900%] Senior [removed: Notes due] [added: Note Due June 1,] 2025 [added: in the aggregate amount of $500,000,000] (incorporated herein by reference to Exhibit [removed: 4.4,] [added: 4.2 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] May [removed: 12, 2015,] [added: 18, 2020,] File No. [removed: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000110465915037235/a15-11340_1ex4d4.htm)] [added: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000094787120000487/ss173781_ex0402.htm)] | | |

| [removed: 4.13] [added: 4.10] | | | | | | [Indenture dated as of May 29, 2013, between the Company and U.S. Bank Association, as Trustee (incorporated herein by reference to Exhibit [removed: 4.1,] [added: 4.1 to the Com](http://www.sec.gov/Archives/edgar/data/885725/000104746913006559/a2215392zex-4_1.htm)[p](http://www.sec.gov/Archives/edgar/data/885725/000104746913006559/a2215392zex-4_1.htm)[a](http://www.sec.gov/Archives/edgar/data/885725/000104746913006559/a2215392zex-4_1.htm)[ny's] Registration Statement on Form [removed: S-3 (File] [added: S-3, File] No [removed: 333-188918) filed on May 29, 2013).](http://www.sec.gov/Archives/edgar/data/885725/000104746913006559/a2215392zex-4_1.htm)] [added: 333-188918.](http://www.sec.gov/Archives/edgar/data/885725/000104746913006559/a2215392zex-4_1.htm)] | | |

| [removed: 4.14] [added: 4.11] | | | | | | [removed: [4.000%] [added: [Form of 4.000%] Senior [removed: Notes] [added: Note] Due [added: March 1,] 2028 [added: in the aggregate amount of $500,000,000] (incorporated herein by reference to Exhibit [removed: 4.2,] [added: 4.2 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] February 26, 2018, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572518000015/exhibit42-xxxnotesdue2028.htm) | | |

| [removed: 4.15] [added: 4.12] | | | | | | [removed: [3.450%] [added: [Form of 3.450%] Senior Note due [added: March 1,] 2024 [added: in the aggregate amount of $850,000,000] (incorporated herein by reference to [removed: exhibit 4.2,] [added: Exhibit 4.2 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] February [removed: 21,] [added: 25,] 2019, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572519000016/exhibit42-3450notesdue2024.htm) | | |

| 4.16 | | | | | | [removed: [3.750%] [added: [Form of 4.700%] Senior Note [removed: due 2026] [added: Due March 1, 2049 in the aggregate amount of $100,000,000] (incorporated herein by reference to [removed: exhibit 4.3,] [added: Exhibit 4.6 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] February [removed: 21,] [added: 25,] 2019, File No. [removed: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572519000016/exhibit43-3750notesdue2026.htm)] [added: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572519000016/exhibit46-4700notesdue2049.htm)] | | |

| [removed: 4.17] [added: 4.14] | | | | | | [removed: [4.000%] [added: [Form of 4.000%] Senior Note due [added: March 1,] 2029 [added: in the aggregate amount of $850,000,000] (incorporated herein by reference to [removed: exhibit 4.4,] [added: Exhibit 4.4 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] February [removed: 21,] [added: 25,] 2019, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572519000016/exhibit44-4000notesdue2029.htm) | | |

| [removed: 4.18] [added: 4.15] | | | | | | [removed: [4.550%] [added: [Form of 4.550%] Senior Note due [added: March 1,] 2039 [added: in the aggregate amount of $750,000,000] (incorporated herein by reference to [removed: exhibit 4.5,] [added: Exhibit 4.5 to the Company's] Current Report on Form 8-K [removed: dated] [added: filed on] February [removed: 21,] [added: 25,] 2019, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572519000016/exhibit45-4550notesdue2039.htm) | | |