Boston Scientific (BSX) 10-K risk factor changes: FY2023 vs FY2022
The 2023-12-31 10-K against the 2022-12-31 one, compared heading by heading and sentence by sentence.
Item 1A74 rewritten20 added18 removed282 unchanged
All filing items1,239 rewritten604 added469 removed2,419 unchanged
Summary
counted, not written
- Item 1A lists 27 risk factor headings: 0 new, 3 reworded and 24 unchanged since FY2022. 1 heading from FY2022 no longer appears.
- Sentence by sentence, 604 added, 469 removed, 1,239 rewritten and 2,419 unchanged across 20 items that differ.
- New this year: Item 1C. CYBERSECURITY.
New Item 1A headings (0)
No risk factor heading in this filing is absent from FY2022.
Removed Item 1A headings (1)
- The global COVID-19 pandemic and related impacts 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 or a similar health crisis and related impacts may adversely impact our business operations, financial performance, results of operations, financial position and the achievement of our strategic objectives.
Reworded Item 1A headings (3)
- We may record future
[removed: intangible asset][added: goodwill] impairment charges related to one or more of our global reporting[removed: units,][added: units or other intangible asset impairment charges,] which could materially adversely impact our results of operations. - Interruption of our supply chain or manufacturing operations, including resulting from natural disasters,
[removed: further]public health crises and other catastrophic events or other events outside of our control, could adversely affect our results of operations and financial condition. - We may not effectively be able to protect our intellectual
[removed: property][added: property, systems, software-based products] or other sensitive data, which could have a material adverse effect on our business, financial condition or results of operations.
A heading is new when no FY2022 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
24 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2023; struck-through words were in FY2022. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. RISK FACTORS
74 rewritten, 20 added, 18 removed, 282 unchanged
You should refer to the explanation of the qualifications and limitations on forward-looking statements set forth at the end of [removed: *Item] [added: Item] 1.
[removed: Business*] [added: Business] of this Annual Report on Form 10-K.
Uncertainty around inflationary pressures, [removed: rising] interest rates and monetary policy could potentially cause new, or exacerbate existing, economic challenges that we may face.
There can be no assurance that there will not be further [added: uncertainty, disruptions or] deterioration in the global economy.
Accordingly, we cannot predict to what extent global economic conditions, including negative or uncertain economic conditions, sovereign debt issues and increased focus on [removed: healthcare] [added: health care] systems and costs in the U.S. and abroad, may impact negatively our average selling prices, net sales and profit margins, operations, procedural volumes and reimbursement rates from third party payers.
In addition, economic and financial market [removed: conditions, including rising interest rates,] [added: conditions] 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: Market] [added: Economic and Market] Risks
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 [added: market segment or segments.]
We also face competition from non-medical device companies, including pharmaceutical [added: companies, biotech] companies and providers of various diagnostic tests, which may offer alternative therapies or diagnostics for disease states also amenable to treatment or diagnosis using our products.
Digital [removed: technologies] [added: technologies, including artificial intelligence (AI) and machine learning capabilities,] have and may continue to increase in their applicability and importance to various aspects of our business, operating and competitive environments, R&D pipeline and product portfolio.
We continue to experience pressures across many of our businesses due to competitive activity, increased market power of our customers as the [removed: healthcare] [added: health care] industry consolidates, national and regional government tenders, economic pressures experienced by our customers, staffing shortages within [removed: healthcare] [added: health care] 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.
Continued consolidation in the [removed: healthcare] [added: health care] industry or additional governmental controls exerted over pricing and access in key markets could lead to increased demands for price concessions or limit or eliminate our ability to sell to certain of our significant market segments, which could have an adverse effect on our business, financial condition or results of operations.
Numerous initiatives and reforms by legislators, regulators and third-party payers to curb the rising cost of [removed: healthcare,] [added: health care,] and to increase access to care, have catalyzed a consolidation of aggregate purchasing power within the markets in which we sell our products.
In some cases, such processes may favor local companies to multinational companies like [removed: Boston Scientific.][added: us.]
As the [removed: healthcare] [added: health care] industry consolidates, competition to provide products and services is expected to continue to intensify, resulting in pricing pressures, decreased average selling prices and the exclusion of certain suppliers from important market segments.
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 [removed: healthcare] [added: health care] industry, 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.
[removed: Healthcare] [added: Health care] cost containment pressures, government payment and delivery system reforms, changes in private payer policies, and marketplace consolidations could decrease the demand for our products, the prices which customers are willing to pay for those products and/or the number of procedures performed using our devices, which could have an adverse effect on our business, financial condition or results of operations.
Our products are purchased principally by hospitals, physicians and other [removed: healthcare] [added: health care] 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 [removed: healthcare] [added: health care] supplies and services provided to their patients.
Governments and payers may institute changes in [removed: healthcare] [added: health care] delivery or payment systems that may reduce funding for services or encourage greater scrutiny of [removed: healthcare] [added: health care] costs.
Further legislative or administrative reforms to the reimbursement systems in the U.S., Japan, 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 [removed: operations][added: operations.]
International net sales accounted for [removed: 40] [added: 41] percent of our global net sales in [removed: 2022.][added: 2023.]
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, go-to-market strategies, geopolitical and economic instability, foreign currency exchange and interest rate fluctuations, competitive product offerings, local changes in [removed: healthcare] [added: health care] financing and payment systems and [removed: healthcare] [added: health care] 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.
Further, international markets are affected by economic pressure to contain [removed: healthcare] [added: health care] costs, which can lead to more rigorous evidence requirements and lower reimbursement rates for either our products directly or procedures in which our products are used.
Governments and payers may also institute changes in [removed: healthcare] [added: health care] delivery systems that may reduce funding for services, seek payback from market participants, or encourage greater scrutiny of [removed: healthcare] [added: health care] costs.
Ultimately, [removed: tariffs and] [added: tariffs, restrictions or] other protectionist measures, [added: and any countermeasures thereto,] as well as prolonged uncertainty, [removed: may] [added: could] have adverse effects on our ability to source and manufacture products in a timely and cost effective manner, thereby adversely affecting our business.
[removed: Lastly, sanctions] [added: Sanctions] and export restrictions are expected to continue to proliferate, leading to greater uncertainty in emerging and growth markets.
Notably the Russia/Ukraine war has created barriers to doing business in [removed: Russia,] [added: Russia] and [added: in parts of Eastern Europe,] the tension between China/Taiwan has created geopolitical shifts in [removed: Asia.][added: Asia, and the Israel/Hamas war has disrupted operations of companies doing business in the Middle East.]
Our outstanding debt balance was [removed: $8.935] [added: $9.102] billion as of December 31, [removed: 2022.][added: 2023.]
Uncertain or negative economic [removed: conditions, as well as rising interest rates,] [added: conditions] could also increase our cost of borrowing in the future or reduce our access to liquidity.
In addition, our credit agreements contain a financial covenant that [removed: require] [added: requires] us to maintain a minimum specified leverage ratio and place other limits on our business.
We may record future [removed: intangible asset] [added: goodwill] impairment charges related to one or more of our global reporting [removed: units,] [added: units or other intangible asset impairment charges,] which could materially adversely impact our results of operations.
[removed: Our integration of acquired businesses requires significant efforts, including] corporate restructuring and the coordination of information technologies, research and development, sales and marketing, operations, regulatory, supply chain, manufacturing, quality systems and finance.
[added: 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.
[removed: In addition, foreign] [added: Foreign] acquisitions involve unique risks, including those related to integration of operations across different geographies, cultures and languages, currency risks and risks associated with the economic, political, legal and regulatory environment in specific countries.
Our failure to manage [added: these challenges] successfully and coordinate the growth of [removed: the acquired companies] [added: such businesses or other investments] could have an adverse impact on our business and our future growth.
In addition, we cannot be certain that the businesses we acquire [added: or invest in] will become profitable or remain so, and if our acquisitions [added: or investments] are not successful, we may record related asset impairment charges in the future or experience other negative consequences on our operating results.
We face competition for acquisitions from other [removed: healthcare] [added: health care] and [removed: non-healthcare] [added: non-health care] acquirers, financial sponsors, and from the market for [removed: Initial Public Offerings] [added: initial public offerings] (IPOs).
- successfully integrate and operate acquired [added: businesses and collaborate with non-wholly owned] businesses,
We monitor the dynamics of the economy, the [removed: healthcare] [added: health care] industry and the markets in which we compete, and assess opportunities for improved operational effectiveness and efficiency and to better align expenses with revenues, while preserving our ability to make investments in research and development projects, capital and our people, which we believe is important to our long-term success.
The 2023 Restructuring Plan [removed: will] further [removed: build] [added: builds] 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 [removed: resiliency.][added: resiliency across production, sterilization, and distribution.]
The global macroeconomic environment has experienced challenging conditions and uncertainty, which could adversely impact our business, financial condition, cash flows and results of operations.
Lastly, geopolitical developments related to various global conflicts are sources of uncertainty and may cause disruptions to global or regional markets, supply chains or operations in the regions.
Our integration of acquired businesses requires significant efforts, including
In addition, we have and may in the future acquire less than full ownership interests in other businesses, which involve unique challenges for effective collaboration.
Further, other parties that hold remaining ownership interests in such businesses may at any time have economic or business goals that are inconsistent with our goals or the goals of such businesses.
The 2023 Restructuring Plan is expected to result in
Additionally, U.S. and international governments have or are considering adopting regulations on the use of per- and polyfluoroalkyl substances (PFAS), and primary manufacturers of PFAS materials have announced that they are discontinuing the supply of such materials.
These changes could have an adverse impact on our ability to manufacture or supply certain products in a timely or cost effective manner or at all.
Other environmental laws may have similar impacts on us or our suppliers, or result in liability to us.
As of December 31, 2023, many countries where we do business, including 17 in the European Union, the United Kingdom, South Korea and Japan have already implemented the Pillar Two global minimum tax into their national laws.
Other countries are considering enacting laws consistent with the Pillar Two rules but have yet to pass legislation, while still others have yet to announce their intentions to adopt.
Additionally, the OECD has continued to issue new guidance on the Pillar Two framework throughout 2023.
In some cases, several competitors are parties in the
Other Risk Factors
International conflicts, including but
not limited to the Russia/Ukraine war, the Israel/Hamas war and tension between China/Taiwan, have also heightened cybersecurity risks on a global basis.
This includes emerging technologies such as generative AI which may be used by malicious actors to create more targeted phishing narratives or otherwise strengthen social engineering capabilities, which may increase our threat landscape.
Some of our IT and OT systems contain legacy third-party software components for which we depend on a layered security approach to protect against exploitation, and such layered security approach may not be effective.
Our product systems also require adherence to evolving regulatory standards and customer patterns and requirements worldwide.
and renewable energy goals, responsible sourcing, social investments and diversity, equity and inclusion.
General Risks
market segment or segments.
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
our operating results.
The global COVID-19 pandemic and related impacts 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 or a similar health crisis and related impacts may adversely impact our business operations, financial performance, results of operations, financial position and the achievement of our strategic objectives.
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.
Because the severity, magnitude, and ultimate duration of the COVID-19 pandemic, or similar health crisis, and its economic consequences are uncertain, subject to rapid change, and difficult to predict, the pandemic’s future potential impact on our business, results of operations and financial performance remains uncertain and difficult to predict.
Further, the ultimate impact of the COVID-19 pandemic 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 in the future may be taken in response to the pandemic or similar public health crises, the impact of the pandemic and actions taken in response on global and regional economies, general economic uncertainty in key global markets and financial market volatility, global economic conditions and levels of economic growth; and any continuing economic effects of the COVID-19 pandemic even after it has subsided.
The COVID-19 pandemic 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.
Factors such as a failure to follow specific
Additionally, the COVID-19 pandemic has given rise to conditions that have created a highly competitive environment for talent.
business practices and operations.
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.
If our incident response, disaster
Any such matters, or related corporate social responsibility
An excerpt. Shown here: 40 of 74 rewritten, all 20 added and all 18 removed. The counts are complete. For every sentence, read Item 1A. RISK FACTORS in the FY2023 filing and the FY2022 filing.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
235 rewritten, 101 added, 102 removed, 340 unchanged
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: 2022] [added: 2023] and [removed: 2021.][added: 2022.]
For additional information on our financial condition and results of operations for the year ended December 31, [removed: 2020,] [added: 2021,] refer to [removed: our previously filed Annual Report on Form 10-K.][added: Item 7.]
Uncertainty around inflationary pressures, [removed: 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 [removed: operations.][added: operations, or result in an economic downtown or recession, which could negatively impact our business operations and results.]
Existing and future potential geopolitical dynamics, including matters related to the Russia/Ukraine war, [added: Israel/Hamas war,] as well as the tension between China/Taiwan, may create economic, supply chain, energy, and other challenges, [added: including disruptions to business operations,] which impact, and may in the future negatively impact our business.
In particular, international conflicts [added: could create instability, have and] may [added: further] result in sanctions, tariffs, and other measures that restrict international trade and [added: may] negatively affect our business operations and results.
In [removed: 2022,] [added: particular,] we [removed: experienced] [added: have experienced, and may continue to experience,] increases in cost and limited availability of [added: certain] raw materials, components, and other inputs necessary to manufacture and distribute our products due to constraints and inflation within the global supply chain, as well as increases in wage costs and the cost and time to distribute our products.
In 2022, we generated net sales of $12.682 [removed: billion,] [added: billion] compared to $11.888 billion in 2021.
This increase of $794 million, or 6.7 percent, included [removed: operational1] [added: operational] growth of [removed: 11.1 percent] [added: 11.1%] and the negative impact of 440 basis points from foreign currency fluctuations.
Operational net sales growth included [removed: organic2] [added: organic] net sales growth of 8.7 percent in 2022 and the positive impact of 240 basis points [removed: from] [added: associated with] our acquisitions of Preventice [removed: Solutions,] [added: Solutions] Inc. (Preventice), Farapulse, Inc. (Farapulse), the global surgical business of [removed: Lumenis, LTD] [added: Lumenis LTD.] (Lumenis) and Baylis [removed: Medical Company Inc. (Baylis Medical)] [added: Medical,] for which there [removed: is] [added: was] less than a full [added: prior] period of comparable net sales.
Refer to the *Business and Market Overview* section for further discussion of our net sales by [removed: global] business.
Our reported net income [removed: available] [added: attributable] to [added: Boston Scientific] common stockholders in 2022 was $642 million, or $0.45 per diluted share.
Excluding these items, adjusted net income [removed: available] [added: attributable] to [added: Boston Scientific] common [removed: stockholders1] [added: stockholders3] for 2022 was $2.459 billion, or $1.71 per diluted share.
Our reported net income [removed: available] [added: attributable] to [added: Boston Scientific] common stockholders in [removed: 2021] [added: 2023] was [removed: $985 million,] [added: $1.570 billion,] or [removed: $0.69] [added: $1.07] per diluted share.
Our reported results for [removed: 2021] [added: 2023] included certain charges and/or credits which are excluded by management for purposes of assessing operating performance, totaling [removed: $1.351] [added: $1.429] billion (after-tax), or [removed: $0.94] [added: $0.98] per diluted share.
Excluding these items, adjusted net income [removed: available] [added: attributable] to [added: Boston Scientific] common [removed: stockholders1] [added: stockholders3] for [removed: 2021] [added: 2023] was [removed: $2.336] [added: $2.999] billion, or [removed: $1.63] [added: $2.05] per diluted share.
[removed: 1 Operational] [added: 3 Adjusted measures, including operational and organic] net sales growth [removed: rates, which exclude the impact of foreign currency fluctuations,] and [removed: other] adjusted [removed: measures, including organic] net [removed: sales, which] [added: income attributable to Boston Scientific common stockholders,] exclude certain items required by generally accepted accounting principles in the United States [removed: (U.S. GAAP),] [added: (GAAP),] are not prepared in accordance with [removed: U.S.] GAAP and should not be considered in isolation from, or as a replacement for, the most directly comparable GAAP measure.
2 Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for [removed: which there are less than a full period of comparable net sales.]
The following is a reconciliation of our results of operations prepared in accordance with [removed: U.S.] GAAP to those adjusted results considered by management.
Refer to *Results of Operations* [added: and *Additional Information*] for a discussion of each reconciling item:
| *(in millions, except per share data)* | | | Income (Loss) Before Income Taxes | | | Income Tax Expense (Benefit) | | | Net Income (Loss) | | | Preferred Stock Dividends | | | Net Income (Loss) [removed: Available] [added: Attributable] to [added: Boston Scientific] Common [removed: Stockholders] [added: Stockholders(4)] | | | Impact per [removed: Share(3)] [added: Share(5)] | | |
| [removed: Intangible] [added: Goodwill and other intangible] asset impairment charges | | | 132 | | | (29) | | | 102 | | | — | | | 102 | | | 0.07 | | |
| Investment portfolio net losses (gains) [added: and impairments] | | | [removed: (30)] [added: 21] | | | [removed: 2] [added: 3] | | | [removed: (28)] [added: 24] | | | — | | | [removed: (28)] [added: 24] | | | [removed: (0.02)] [added: 0.02] | | |
| European Union (EU) Medical device regulation (MDR) implementation costs | | | [removed: 71] [added: 69] | | | (10) | | | [removed: 62] [added: 59] | | | — | | | [removed: 62] [added: 59] | | | 0.04 | | |
| Debt extinguishment [added: net] charges | | | 194 | | | (45) | | | 149 | | | — | | | 149 | | | 0.10 | | |
| | | | Year Ended December 31, [removed: 2021] [added: 2023] | | | | | | | | | | | | | | | | | |
| Acquisition/divestiture-related net charges (credits) | | | [removed: (450)] [added: 373] | | | [removed: (2)] [added: (21)] | | | [removed: (453)] [added: 352] | | | — | | | [removed: (453)] [added: 352] | | | [removed: (0.32)] [added: 0.24] | | |
| Restructuring and restructuring-related net charges (credits) | | | [removed: 191] [added: 185] | | | [removed: (22)] [added: (29)] | | | [removed: 169] [added: 156] | | | — | | | [removed: 169] [added: 156] | | | [removed: 0.12] [added: 0.11] | | |
| Litigation-related net charges (credits) | | | [removed: 430] [added: (111)] | | | [removed: (98)] [added: 23] | | | [removed: 331] [added: (88)] | | | — | | | [removed: 331] [added: (88)] | | | [removed: 0.23] [added: (0.06)] | | |
| Investment portfolio net losses (gains) [added: and impairments] | | | [removed: 181] [added: (30)] | | | [removed: (43)] [added: 2] | | | [removed: 137] [added: (28)] | | | — | | | [removed: 137] [added: (28)] | | | [removed: 0.10] [added: (0.02)] | | |
| Deferred tax expenses (benefits) | | | — | | | [removed: 132] [added: 155] | | | [removed: 132] [added: 155] | | | — | | | [removed: 132] [added: 155] | | | [removed: 0.09] [added: 0.11] | | |
| Discrete tax items | | | — | | | [removed: (5)] [added: 8] | | | [removed: (5)] [added: 8] | | | — | | | [removed: (5)] [added: 8] | | | [removed: (0.00)] [added: 0.01] | | |
[removed: (3)] [added: 5] For [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] the effect of assuming the conversion of our [removed: Series A 5.5%] [added: 5.50%] Mandatory Convertible Preferred [removed: Stock] [added: Stock, Series A] (MCPS) into shares of common stock was anti-dilutive, and therefore excluded from the calculation of [removed: EPS.][added: *Net income (loss) per common share — diluted* (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) [removed: available] [added: attributable] to [added: Boston Scientific] common stockholders*.
Within the Cardiovascular segment, the [removed: newly formed] Cardiology division represents the combined former Rhythm Management and Interventional Cardiology divisions.
The following section describes our results of operations by reportable segment and [removed: business unit.][added: business.]
For additional information on our businesses and [removed: their] product offerings, [removed: see] [added: refer to] *Item 1.
Our Endoscopy business develops and manufactures devices to diagnose and treat a broad range of gastrointestinal [added: (GI)] and pulmonary conditions with innovative, less invasive technologies.
Net sales of Endoscopy products of [removed: $2.221] [added: $2.482] billion represented [removed: 18] [added: 17] percent of our consolidated net sales in [removed: 2022.][added: 2023.]
Endoscopy net sales increased [removed: $80] [added: $261] million, or [removed: 3.7] [added: 11.7] percent, in [removed: 2022] [added: 2023] compared to [removed: 2021.][added: 2022.]
This increase included operational net sales growth of [removed: 8.1] [added: 12.3] percent and the negative impact of [removed: 440] [added: 60] basis points from foreign currency fluctuations.
Management's Discussion and Analysis of Financial Condition and Results of Operations in our previously filed Annual Report on Form 10-K.
In 2023, our net sales were $14.240 billion, compared to $12.682 billion in 2022.
Operational net sales growth included organic2 net sales growth of 12.3 percent in 2023 and the positive impact of 80 basis points driven by our majority stake investment in Acotec Scientific Holdings Limited (Acotec) and the acquisitions of Apollo Endosurgery, Inc. (Apollo) and Relievant Medsystems, Inc. (Relievant) during the first, second and fourth quarters of 2023, respectively, as well as the divestiture of our pathology business during the second quarter of 2023 and our acquisition of Baylis Medical Company Inc. (Baylis Medical) during the first quarter of 2022, for which there is less than a full period of comparable net sales.
1 Operational net sales growth excludes the impact of foreign currency fluctuations.
which there are less than a full period of comparable net sales.
| Reported | | | $ | 1,985 | | $ | 393 | | $ | 1,592 | | $ | (23) | | $ | 1,570 | | $ | 1.07 | |
| Amortization expense | | | 828 | | | (115) | | | 713 | | | — | | | 709 | | | 0.48 | | |
| Goodwill and other intangible asset impairment charges | | | 58 | | | (4) | | | 54 | | | — | | | 54 | | | 0.04 | | |
| Adjusted | | | $ | 3,407 | | $ | 382 | | $ | 3,025 | | $ | (23) | | $ | 2,999 | | $ | 2.05 | |
| *(in millions, except per share data)* | | | Income (Loss) Before Income Taxes | | | Income Tax Expense (Benefit) | | | Net Income (Loss) | | | Preferred Stock Dividends | | | Net Income (Loss) Attributable to Boston Scientific Common Stockholders | | | Impact per Share(5) | | |
| EU MDR implementation costs | | | 71 | | | (10) | | | 62 | | | — | | | 62 | | | 0.04 | | |
4 Excludes $4 million of amortization expense attributable to noncontrolling interests in 2023.
On June 1, 2023, all outstanding shares of our MCPS automatically converted into shares of common stock.
Operational net sales growth included organic net sales growth of 11.1 percent in 2023, and the positive impact of 120 basis points from our acquisition of Apollo and the divestiture of our pathology business in the second quarter of 2023.
Organic net sales growth was primarily driven by growth within our deep brain stimulation (DBS) franchise led by our Vercise Genus™ DBS System.
Operational net sales growth included organic net sales growth of 10.9 percent, and the positive impact of 160 basis points from our majority stake investment in Acotec which we acquired in the first quarter of 2023.
Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2023, modified our list to include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.
We have revised prior year amounts to conform to the current year's presentation.
Operational growth was primarily driven by growth in China, fueled by the breadth of our portfolio and focus on innovation and strong commercial execution.
Economic Environment
Our business has been impacted by global supply chain disruptions which improved in 2023 compared to 2022, however challenges still exist.
The increase in our 2022 net sales was primarily driven by 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.
| Manufacturing and supply costs | | | 1.7% | | |
The primary factors contributing to the increase in our gross profit margin for 2023 compared to 2022 were increased sales of higher margin products, as well as improvements in manufacturing, raw material and component, and freight costs.
These impacts were partially offset by the unfavorable impact of foreign currency and period expenses.
The increase in *SG&A expenses* was due primarily to higher selling costs driven by higher global net sales, as well as costs to support recent and upcoming product launches, including the Farapulse™ Pulsed Field Ablation System, and was also due to comparatively higher acquisition-related and restructuring-related expenses.
In 2023, *Amortization expense* increased $25 million, or 3 percent, as compared to 2022.
In addition, we made payments of $76 million and $371 million associated with prior acquisitions during 2023 and 2022, respectively, following the achievement of revenue and/or regulatory milestones.
The restructuring reserve balance as of December 31, 2023 was $41 million.
We recorded litigation-related net credits of $111 million in 2023 and litigation-related net charges of $173 million in 2022.
In 2023, litigation-related net credits primarily related to the settlement of offensive patent litigation.
In 2022, litigation-related net charges primarily related to litigation associated with our transvaginal surgical mesh products.
(1) Net gains (losses) on investments include investment portfolio net gains and losses and impairments as well as the impact of
recording our share of the earnings or losses of equity method investees.
We paid tax of $16 million to the IRS reflecting the net balance of amounts due for the tax period including an increase to past transition tax installment payments for periods prior to 2023 and interest.
The subsequent transition tax payments in 2024 and 2025 will be increased to reflect the final audit settlement.
It is possible that in certain circumstances CAMT could result in an additional tax liability in a particular year due to temporary differences between book and taxable income.
Based on our evaluation, we currently do not anticipate the Inflation Reduction Act will have a material impact on our financial position, results of operations, or cash flows.
As of December 31, 2023, we had $865 million of unrestricted *Cash and cash equivalents* on hand, including approximately $123 million held by Acotec, a less than wholly owned entity in which we acquired a majority stake in the first quarter of 2023.
On March 1, 2023, we entered into an amendment of the 2021 Revolving Credit Facility, which provided for an extension of the scheduled maturity date to May 10, 2027 and replaced the London Interbank Offered Rate (LIBOR) with the Secured Overnight Financing Rate (SOFR) as the Eurocurrency Rate for Dollars, including applicable credit spread adjustments and relevant SOFR benchmark provisions, as well as modification to the calculation of consolidated Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA), described under *Financial Covenant* below.
Economic Trends
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.
In 2023, we expect the impact of macroeconomic and supply chain conditions on our business to be similar to 2022.
COVID-19 Pandemic
In March 2020, the World Health Organization declared COVID-19, including all additional variations and strains thereof, a global pandemic (COVID-19 pandemic).
Economic conditions created in part by the COVID-19 pandemic, have had, and may in the future have, a negative impact on our profitability.
Further, the 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, may negatively impact demand for our products, net sales, gross profit margin and operating expenses as a percentage of net sales.
While the COVID-19 pandemic 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 intend to manage through these challenges with strategic focus and the winning spirit of our global team.
| Reported | | | $ | 1,076 | | $ | 36 | | $ | 1,041 | | $ | (55) | | $ | 985 | | $ | 0.69 | |
| Amortization expense | | | 741 | | | (65) | | | 676 | | | — | | | 676 | | | 0.47 | | |
| Intangible asset impairment charges | | | 370 | | | (51) | | | 318 | | | — | | | 318 | | | 0.22 | | |
| European Union (EU) Medical device regulation (MDR) implementation costs | | | 49 | | | (4) | | | 45 | | | — | | | 45 | | | 0.03 | | |
| Adjusted | | | $ | 2,587 | | $ | 196 | | $ | 2,391 | | $ | (55) | | $ | 2,336 | | $ | 1.63 | |
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.
We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities.
Periodically, we assess our list of Emerging Markets countries, which currently include the following countries: Brazil, Chile, China, Colombia, Czech Republic, India, Indonesia, Malaysia, Mexico, Philippines, Poland, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Türkiye and Vietnam.
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.
Prior to the divestiture, we presented the Specialty Pharmaceuticals business as a standalone operating segment alongside our reportable segments.
In 2021, we generated net sales of $11.888 billion compared to $9.913 billion in 2020.
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.
Operational net sales also included $202 million in 2020 associated with our intrauterine health franchise and the Specialty Pharmaceuticals business, divested in the second quarter of 2020 and first quarter of 2021, respectively.
The increase in our 2021 net sales was primarily driven by the recovery of elective and semi-emergent procedure volumes compared to 2020 when the COVID-19 pandemic had a more significant impact on our net sales.
| | | | | | |
| Abnormal production variances | | | 1.3% | | |
| LOTUS Edge™ discontinuation | | | 0.9% | | |
The primary factors contributing to the increase in our gross profit margin for 2021 compared to 2020 were higher sales volumes and favorable product mix associated with the resumption of the procedures using higher-margin products following reduced elective procedure volumes due to the COVID-19 pandemic.
In addition, our gross profit margin in 2020 was negatively impacted by abnormal production variances attributable to manufacturing plant shut-downs, inventory charges related to the discontinuation of our LOTUS platform and sales return reserves due to our WATCHMAN FLX™ consignment conversion.
These improvements were partially offset by price declines related primarily to sales of our coronary drug-eluting stent systems and foreign currency fluctuations.
In addition, macro-environment factors negatively impacted our gross profit margin, including the cost of operating manufacturing plants with COVID-19 specific health and safety measures and increases in costs of certain raw materials, direct labor and freight.
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
The increase in *SG&A expenses* was primarily due to higher selling costs driven by higher global net sales and the targeted lifting of spending controls implemented in 2020 in response to the then escalating COVID-19 pandemic.
In addition, SG&A expenses in 2021 were further impacted by higher restructuring-related spend and acquisition-related costs.
In 2021, *Amortization expense* decreased $48 million, or 6 percent, as compared to 2020.
The decrease was driven by the divestiture of the Specialty Pharmaceuticals business, partially offset by the addition of amortizable intangible assets associated with recent acquisitions.
The impairment charges recorded in 2021 were primarily associated with amortizable technology-related intangible assets that were initially established following our acquisition of VENITI, Inc., which is now part of our Peripheral Interventions business.
These charges resulted from management’s decision to discontinue commercialization of the VICI VENOUS STENT™ System following a voluntary recall, due to cost to remediate and time to return to market.
In addition, during 2021, we impaired the IPR&D assets established in connection with our acquisition of Millipede, Inc. which is now part of our Cardiology business.
In 2021, the net benefits related to a reduction in the contingent consideration liability for certain prior acquisitions for which we reduced the probability of achievement of associated revenue and/or regulatory milestones upon which payment is conditioned, or, for milestones that would not be achieved due to management's discontinuation of the associated R&D program.
The 2019 Restructuring Plan was intended to support our effort to improve operating performance and meet anticipated market demands by ensuring that we were appropriately structured and resourced to deliver sustainable value to patients and customers.
Key activities under the 2019 Restructuring Plan included supply chain network optimization intended to maximize our global manufacturing and distribution network capacity and building functional capabilities to support business growth.
An excerpt. Shown here: 40 of 235 rewritten, 40 of 101 added and 40 of 102 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS in the FY2023 filing and the FY2022 filing.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
13 rewritten, 1 added, 1 removed, 34 unchanged
We use both nonderivative (primarily [added: European] manufacturing [removed: operations outside the U.S.)] [added: operations)] and derivative instruments to manage our earnings and cash flow exposure to changes in currency exchange rates.
We had currency derivative instruments outstanding in the contract amount of [removed: $7.324] [added: $5.899] billion as of December 31, [removed: 2022] [added: 2023] and [removed: $8.381] [added: $7.324] billion as of December 31, [removed: 2021.][added: 2022.]
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: $208] [added: $236] million as of December 31, [removed: 2022] [added: 2023] compared to [removed: $298] [added: $208] million as of December 31, [removed: 2021.][added: 2022.]
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: $254] [added: $288] million as of December 31, [removed: 2022] [added: 2023] compared to [removed: $364] [added: $254] million as of December 31, [removed: 2021.][added: 2022.]
We had no interest rate derivative instruments outstanding as of December 31, [removed: 2022] [added: 2023] and December 31, [removed: 2021.][added: 2022.]
As of December 31, [removed: 2022, $8.986] [added: 2023, $9.136] 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: 2022,] [added: 2023,] our outstanding debt obligations at fixed interest rates were comprised of senior notes.
See *Note D – Hedging Activities and Fair Value Measurements* to our consolidated financial statements [removed: contained] [added: included] in Item 8.
We have audited the accompanying consolidated balance sheets of Boston Scientific Corporation (the Company) as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] the related consolidated statements of operations, comprehensive income [removed: (loss),] [added: (loss),] stockholders' equity and cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] 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: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] 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: 2022,] [added: 2023,] 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 [removed: 23, 2023] [added: 20, 2024] expressed an unqualified opinion thereon.
| As disclosed in Note B to the consolidated financial statements, during [removed: 2022,] [added: 2023,] the Company completed the acquisition of [removed: Baylis Medical] [added: a majority stake investment in Acotec for a purchase price of $381 million. The] Company [added: also completed the acquisitions of Apollo Endosurgery,] Inc. for a purchase price of [removed: $1.46 billion, net] [added: $636 million and Relievant Medsystems, Inc. for a purchase price] of [removed: cash acquired.] [added: $1,067 million, inclusive of a contingent consideration liability with a fair value of $273 million related to future milestone and earn out payments based on future sales performance.] The [removed: transaction was accounted for] [added: Company determines the fair value of these contingent consideration arrangements, both] as [added: part of the initial purchase price allocation, and on an ongoing basis each reporting period until the arrangements are settled. The valuation of contingent consideration represents] a [removed: business combination.] [added: 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 valuing the liabilities.] Auditing the Company’s accounting for the [removed: acquisition] [added: business combinations] was complex due to the significant estimation required by management to determine the fair value of identified intangible assets, which totaled [removed: $657] [added: $907] million and principally consisted of developed [removed: technology.] [added: technology, and the significant estimation required by management to determine the fair value of the contingent consideration liability.] A significant emphasis is placed on the appropriateness of the estimates used by management to determine the fair value of acquired intangible assets [added: and the contingent consideration liability] 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 [removed: assets.] [added: assets acquired.] The significant assumptions used to estimate the [added: fair] 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. [added: The Company used the income approach to measure the contingent consideration liability assumed. The significant assumptions used to estimate the fair value of the contingent consideration liability included 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 [removed: acquisitions.] [added: business combination transactions.] 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 read the purchase [removed: agreement,] [added: agreements,] 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 [removed: assets,] [added: assets acquired,] 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. [added: To test the estimated fair value of the contingent consideration liability, we performed audit procedures that included, among others, evaluating the methodology used to value the liability, understanding the terms of the arrangements and conditions that must be met for the amounts to become payable, and testing the significant assumptions used in the model, as described above.] 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 20, 2024
February 23, 2023
Item 1. BUSINESS
86 rewritten, 34 added, 28 removed, 289 unchanged
We advance science for life by providing a broad range of high performance solutions to address unmet patient needs and reduce the cost of [removed: healthcare.][added: health care.]
We expect to continue to invest in our core [removed: franchises] [added: businesses] and pursue opportunities to diversify and further expand our presence in strategic, high-growth adjacencies and new global markets, including growth within the countries we define as emerging markets.
In the past several years, we have completed numerous acquisitions in support of our growth strategy, both strengthening our core [removed: franchises] [added: businesses] and expanding into high growth adjacent markets.
Refer to discussion of *Community Outreach* below and *Corporate [removed: Sustainability*] [added: Responsibility*] included in Item 7.
The following describes our key product offerings and new product innovations by reportable [removed: segment.][added: segment and business unit.]
Our Endoscopy business develops and manufactures devices to diagnose and treat a broad range of gastrointestinal [added: (GI)] and pulmonary conditions with innovative, less invasive technologies.
- AXIOS™ Stents and Electrocautery Enhanced Delivery Systems, the first, and currently only [removed: stents] [added: stent] systems in the U.S. indicated for endoscopic drainage of pancreatic [removed: pseudocysts,][added: pseudocysts and used to facilitate endoscopic drainage of the gallbladder for patients with acute cholecystitis,]
- EXALT™ Model D Single-Use Duodenoscopes for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures, the first U.S. Food and Drug Administration (FDA)-cleared single-use (disposable) duodenoscopes on the [removed: market,][added: market and]
Our Urology business develops and manufactures devices to treat various urological [removed: and pelvic] conditions for both male and female anatomies, including kidney stones, benign prostatic hyperplasia (BPH), prostate cancer, erectile dysfunction and incontinence.
- Lumenis Pulse™ Holmium Laser Systems with MOSES™ Technology, complemented by a full line of laser fibers and accessories used in urology [removed: and otolaryngology] procedures,
- our [removed: Prosthetic Urology] [added: prosthetic urology] portfolio, which includes [removed: AMS 700™,] our [added: AMS 700™] penile [removed: implants] [added: implant] to treat erectile dysfunction and [removed: AMS 800™,] our [removed: urinary control systems] [added: AMS 800™ Artificial Urinary Sphincter] to treat male urinary incontinence,
In the first quarter of 2023, we received FDA clearance for and [removed: will begin a limited market release of] [added: launched] our LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope [removed: system] with the ability to monitor intrarenal pressure in real-time during ureteroscopy procedures.
- Precision 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, with proprietary features such as Multiple Independent Current Control, our Illumina 3D™ Proprietary Programming Software and FAST™ Therapy for [removed: profound parathesia-free pain relief in minutes, used by physicians to target specific areas of pain and customize stimulation of nerve fibers more precisely,]
- [removed: Our] [added: our] Cognita™ Practice Optimization suite of tools designed to increase awareness, streamline patient management, and sustain long-term outcomes for [removed: patients,][added: patients]
- Vercise [removed: Gevia™ and Vercise] Genus™ Deep Brain Stimulation (DBS) [removed: Systems] [added: System] 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, utilizing Stimview™ XT, our proprietary DBS visualization software developed in collaboration with Brainlab AG, providing clinicians with real-time, 3D visualization] and [added: stimulation of brain anatomy.]
- Superion™ Indirect Decompression Systems, minimally-invasive devices used to improve physical function and reduce pain in patients with moderate lumbar spinal stenosis [removed: (LSS).][added: (LSS),]
- OptiCross™ [removed: IVUS] [added: Intravascular Ultrasound (IVUS)] Imaging Catheters,
- ROTAPRO™ Rotational Atherectomy Systems, [removed: which regulate] [added: designed to treat coronary calcification in lesions by regulating] the flow of air to the advancer, controlling burr rotation speed, and also [removed: monitor] [added: monitoring] and [removed: display] [added: displaying] burr rotation speed and rotational atherectomy procedural time,
- EMBLEM™ MRI S-ICD [removed: System,] [added: Systems,] the world's [removed: first, and currently only,] [added: first] 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 heart,
[removed: Our] [added: Additionally, our] entire transvenous defibrillator portfolio leverages our EnduraLife™ Battery Technology and has magnetic resonance imaging (MRI) conditional labeling when used with our current generation of leads.
- [added: A portfolio of radiofrequency (RF)] cardiac ablation [removed: catheters] [added: catheters,] including [removed: the Blazer™, IntellaNav™, IntellaNav Stablepoint™ and IntellaTip MiFi Open-Irrigated Ablation Catheter families, featuring a unique Total Tip Cooling™ Design and] [added: our INTELLANAV STABLEPOINT™ catheter, which also includes] DIRECTSENSE™ Software for monitoring [removed: radiofrequency (RF)] [added: RF] energy [removed: delivery] during [removed: procedures,][added: ablations and]
- IntellaMap Orion™ Mapping Catheters, for use with our Rhythmia Mapping System to provide high-density, high-resolution maps of the [removed: heart,][added: heart.]
- Farapulse™ Pulsed Field Ablation (PFA) [removed: Systems] [added: System] for the treatment of [removed: atrial fibrillation (AF),][added: AF,]
- POLARx™ Cryoablation Systems for the treatment of [removed: AF and][added: AF,]
- Eluvia™ Drug Eluting Vascular Stent Systems, innovative stents built on the Innova stent platform, designed to deliver a sustained dosage of paclitaxel during the time when restenosis is most likely to occur, [added: in addition to the Eluvia™ line extension, the longest-length stent available for treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery,]
- EMBOLD™ Detachable Coil System, used for arterial and venous embolizations in the peripheral [removed: vasculature,] [added: vasculature] and
In the current environment of managed care, with economically motivated buyers, consolidation among [removed: healthcare] [added: health care] providers, increasing prevalence and importance of regional and national tenders, increased competition and declining reimbursement rates, we [removed: have been increasingly] [added: are also] required to compete on the basis of price, value, reliability and efficiency.
- continually provide quality products and enhance our quality [removed: systems,][added: systems and]
- internal research and development programs, regulatory design and clinical science, as well as other programs obtained through our strategic acquisitions and [removed: alliances,] [added: alliances] and
In addition to internal development, we work with [removed: hundreds of] leading research institutions, universities and clinicians around the world to develop, evaluate and clinically test our products.
[removed: In 2022, we marketed] [added: We market] our products and solutions to [removed: approximately 36,000] hospitals, clinics, outpatient facilities and medical offices in [removed: 130] [added: 140] countries worldwide.
[removed: Large] [added: In addition, large] group purchasing organizations, hospital networks and other buying groups [removed: have become increasingly] [added: are] important to our business and represent a substantial portion of our net sales.
We have an ongoing supplier resiliency program which identifies and mitigates risk and have taken measures to mitigate the impact of challenges within the global supply [removed: chain, including those caused] [added: chain] in [removed: part by the COVID-19 pandemic.][added: recent years.]
[removed: We have experienced increased levels of unpredictability] [added: Predictability] in the supply of certain raw materials and components used in the manufacturing of our [removed: products.][added: products has improved but continues to be a risk for certain materials and vendors.]
See *Note I – Commitments and Contingencies* to our [removed: 2022] [added: 2023] consolidated financial statements included in Item 8.
The medical devices that we manufacture, market and commercialize are subject to regulation by numerous worldwide regulatory bodies, including the [removed: U.S.] FDA and comparable international regulatory agencies.
In the European Union (EU), we are required to comply with the Medical Device Regulation (MDR or EU MDR) which became effective [added: in] May 2021, superseding the existing Medical Device and Active Implantable Medical Device Directives.
In [removed: Japan] [added: Japan,] we are required to comply with Japan’s Ministry of Health, Labor and Welfare (MHLW) regulations.
The FDA may also enjoin and restrain a company for certain violations of the Food, Drug and Cosmetic Act and the Safe Medical Devices Act, [removed: pertaining to medical devices, or initiate action for criminal prosecution of such violations.]
Our quality system is designed to enable us to satisfy various international quality system regulations, including those of the [removed: U.S.] FDA with respect to products sold in the U.S. [removed: All of our medical device manufacturing facilities and distribution centers are certified under] [added: The International Standards Organization (ISO) established] the ISO 13485 quality system standard, [removed: established by the International Standards Organization (ISO) for medical devices,] which includes requirements for an implemented quality system that applies to component quality, supplier control, product design and manufacturing operations.
In the second quarter of 2023, we completed the acquisition of Apollo Endosurgery, Inc., a public company that has developed and commercialized endoscopic suturing devices including OverStitch™ Endoscopic Suturing Systems and X-Tack™ Endoscopic HeliX Tacking Systems and endobariatric devices including the Apollo ESG™ and Apollo REVISE™ Systems, the first devices authorized by the FDA for endoscopic sleeve gastroplasty and endoscopic bariatric revision procedures, as well as the Orbera™® Intragastric Balloon for endoscopic weight management.
Pending Axonics Acquisition
On January 8, 2024, we announced our entry into a definitive agreement to acquire Axonics, Inc. (Axonics), a publicly traded medical technology company primarily focused on the development and commercialization of devices to treat urinary and bowel dysfunction.
The Axonics product portfolio includes the Axonics R20™ and Axonics F15™ Systems used to deliver sacral neuromodulation (SNM) therapy for the treatment of over-active bladder and fecal incontinence.
The purchase price is $71.00 in cash per share, or approximately $3.670 billion.
The transaction is expected to close in the first half of 2024, subject to customary closing conditions.
We plan to fund the acquisition through a mix of cash on hand and new debt.
The Axonics business will be integrated into our Urology division.
profound parathesia-free pain relief in minutes, used by physicians to target specific areas of pain and customize stimulation of nerve fibers more precisely,
In the second quarter of 2023, we received FDA approval for the Vercise™ Neural Navigator 5 Software, which when used with the Vercise Genus™ DBS systems can help provide clinicians with simple and actionable data for efficient programming in the treatment of people living with Parkinson's disease or essential tremor.
In addition, in the fourth quarter of 2023, we completed the acquisition of Relievant Medsystems, Inc., a privately held medical technology company that has developed and commercialized the Intracept™ Intraosseous Nerve Ablation System, the only FDA-cleared system to treat vertebrogenic pain, a form of chronic low back pain.
- WOLVERINE™ Coronary Cutting Balloon™, a cutting balloon angioplasty device with a unique mechanism of action that enables precise vessel preparation across a wide range of resistant lesions,
- AGENT™ Drug-Coated Balloon, which is designed to provide a targeted, therapeutic dose of anti-proliferative paclitaxel to the coronary lesion and minimize downstream particulates,
In the third quarter of 2023, we received CE Mark, FDA clearance and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval for the AVVIGO™+ Multi-Modality Guidance System, a next-generation technology that provides high-quality IVUS imaging and physiologic assessment of coronary vessels and lesions.
In the third quarter of 2023, we received FDA approval for the latest-generation WATCHMAN FLX™ Pro LAAC Device, which is designed to improve visualization during device placement, reduce device-related thrombus post-implant and treat a broader range of patient anatomies.
In the third quarter of 2023, we received FDA clearance and launched the next-generation LUX-Dx II/II+™ ICM system for long-term monitoring of arrhythmias.
- VersaCross Connect™ Access Solutions for our WATCHMAN FXD Curve™ Sheath, Polarsheath™ and Faradrive™ Steerable Sheath providing safe and efficient access to the left side of the heart,
In the third quarter of 2023, we received FDA approval for the POLARx™ Cryoablation System, which includes the POLARx™ FIT Cryoablation Balloon Catheter, and in the first quarter of 2024, we received FDA approval for the FARAPULSE™ PFA System, both of which are used to treat patients with paroxysmal AF.
In the first quarter of 2023, we acquired a majority stake investment in Acotec Scientific Holdings Limited (Acotec), a publicly traded Chinese manufacturer of drug-coated balloons and other products used in the treatment of vascular and other diseases, complementing our existing Peripheral Interventions portfolio.
In addition, in the second quarter of 2023, we received FDA 510(k) clearance for the EMBOLD™ Soft and Packing Coils, which, along with the EMBOLD™ Fibered Coil, complete the EMBOLD™ Detachable Coil System, a peripheral embolization platform for vessel occlusion designed to simplify operator workflow and streamline inventory for hospitals.
In the fourth quarter of 2023, we started to introduce our OBSIDIO™ Conformable Embolic for use in the embolization of hypervascular tumors and blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature.
pertaining to medical devices, or initiate action for criminal prosecution of such violations.
All of our medical device manufacturing facilities and key distribution sites are certified under the ISO 13485 quality system standard.
We continue to focus on improving workforce diversity through intentional actions to drive meaningful change.
Since 2021, our annual bonus plan has included performance measures for certain environmental, social and governance (ESG) goals.
For additional information on our annual bonus plan, refer to our Proxy Statement for the 2023 Annual Meeting of Shareholders.
In 2023, we provided approximately $2 million in aid to 9 countries impacted by disasters through Boston Scientific and Boston Scientific Foundation funding.
Many employees chose to support their communities and causes they are passionate about through the use of the Employee Matching Gifts program.
Our global and U.S. Signature Health Grant programs support education and development for health care workers in vulnerable communities worldwide.
To help offset a World Health Organization projected shortfall of 10 million health care workers by 2030, we collaborate with organizations training medical staff to conduct critical disease screenings.
In 2023, we provided approximately $1 million in these grants to organizations working in the U.S., Colombia, Peru and India.
In 2023, more than 110,000 students were reached through our STEM activities and events.
Our Business
- The impact of disruptions in the supply of the materials and components used in manufacturing our products or the sterilization of our products,
- Acquire™ Endoscopic Ultrasound Fine Needle Biopsy Devices, which are designed to obtain larger tissue specimens for histological assessment and diagnosis of diseases such as pancreatic cancer, liver cancer and stomach lesions and
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.
Our Vercise™ DBS Systems are approved in the U.S. as an adjunctive therapy that aids in reducing some of the symptoms of moderate to advanced Parkinson’s disease as well as for patients diagnosed with essential tremor.
The Vercise Genus™ DBS platform features a full portfolio of primary cell and rechargeable MRI conditional systems with Bluetooth connectivity and the Cartesia™ Directional Lead, providing multi-directional stimulation designed for greater precision, intended to minimize side effects 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.
- intracardiac ultrasound catheters, delivery sheaths and other accessories
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.
We are also the first company to provide physicians with both a drug-eluting stent and drug-coated balloon option for the treatment of patients with PAD.
- WOLF Thrombectomy™ Platform, which is designed to mechanically remove the clots without damaging blood vessels, while also minimizing blood loss,
We believe the current global economic conditions and healthcare reform measures could continue to put additional competitive pressure on us, including on our average selling prices, overall procedure rates and addressable market sizes.
Government and private sector initiatives related to limiting the
We are committed to our goal of making further progress toward expanding our workforce diversity.
In 2020, we set measurable Diversity, Equity & Inclusion (DE&I) goals with our “3UP by 2023” initiative, which included aspirations of a three percentage point increase in representation of both women and multicultural talent at the supervisor and manager level to 43 percent and 23 percent, respectively, by December 31, 2022.
As of December 31, 2022, 42.6 percent of management roles were held by women and, within the U.S and Puerto Rico, 22.6 percent were held by multicultural employees.
While we are making progress, our work is far from over.
We are committed to intentional action to drive meaningful change.
As evidence of our commitment to expand DE&I, in 2021, we introduced an ESG scorecard, including DE&I metrics, to our Annual Bonus Plan.
They provide forums for us to learn from
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.
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.
In February 2023, we launched an additional match campaign through our Employee Matching Gifts Program for aid to Türkiye and Syria and are also providing volunteer opportunities for our employees based in Türkiye to give back to their local communities.
Within many of the communities in which we operate, we have launched and funded a multi-year program to combat racism, inequity and injustice focused on five pillars: community, economic empowerment, education, healthcare disparities and government policies.
Our Businesses
An excerpt. Shown here: 40 of 86 rewritten, all 34 added and all 28 removed. The counts are complete. For every sentence, read Item 1. BUSINESS in the FY2023 filing and the FY2022 filing.
Item 3. LEGAL PROCEEDINGS
1 rewritten, 0 added, 0 removed, 1 unchanged
Financial Statements and Supplementary Data of [added: Part II of] this Annual Report on Form [removed: 10-Kand] [added: 10-K, which is] incorporated herein by reference.
Cover and table of contents
26 rewritten, 6 added, 6 removed, 63 unchanged
For the fiscal year ended December 31, [removed: 2022][added: 2023]
The aggregate market value of the registrant’s common stock held by non-affiliates was approximately [removed: $53.2] [added: $79.0] billion based on the last reported sale price of [removed: $37.27] [added: $54.09] of the registrant’s common stock on the New York Stock Exchange on June 30, [removed: 2022,] [added: 2023,] 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: 2023] [added: 2024] was [removed: 1,434,780,104.][added: 1,467,095,627.]
Portions of the registrant’s definitive proxy statement to be filed within 120 days of December 31, [removed: 2022] [added: 2023] with the Securities and Exchange Commission in connection with its [removed: 2023] [added: 2024] Annual Meeting of Stockholders are incorporated by reference into Part III of this Form 10-K.
| [ITEM [removed: 1.](#i0700a8f6ea1f4171b75e8081068a452b_16)] [added: 1.](#if966a1efad444c678cb814a4ff4d0758_16)] | | | [removed: [BUSINESS](#i0700a8f6ea1f4171b75e8081068a452b_16)] [added: [BUSINESS](#if966a1efad444c678cb814a4ff4d0758_16)] | | | [removed: [3](#i0700a8f6ea1f4171b75e8081068a452b_16)] [added: [3](#if966a1efad444c678cb814a4ff4d0758_16)] | | |
| [ITEM [removed: 1A.](#i0700a8f6ea1f4171b75e8081068a452b_19)] [added: 1A.](#if966a1efad444c678cb814a4ff4d0758_19)] | | | [RISK [removed: FACTORS](#i0700a8f6ea1f4171b75e8081068a452b_19)] [added: FACTORS](#if966a1efad444c678cb814a4ff4d0758_19)] | | | [removed: [18](#i0700a8f6ea1f4171b75e8081068a452b_19)] [added: [19](#if966a1efad444c678cb814a4ff4d0758_19)] | | |
| [ITEM [removed: 1B.](#i0700a8f6ea1f4171b75e8081068a452b_22)] [added: 1B.](#if966a1efad444c678cb814a4ff4d0758_22)] | | | [UNRESOLVED STAFF [removed: COMMENTS](#i0700a8f6ea1f4171b75e8081068a452b_22)] [added: COMMENTS](#if966a1efad444c678cb814a4ff4d0758_22)] | | | [removed: [32](#i0700a8f6ea1f4171b75e8081068a452b_22)] [added: [33](#if966a1efad444c678cb814a4ff4d0758_22)] | | |
| [ITEM [removed: 2.](#i0700a8f6ea1f4171b75e8081068a452b_25)] [added: 2.](#if966a1efad444c678cb814a4ff4d0758_25)] | | | [removed: [PROPERTIES](#i0700a8f6ea1f4171b75e8081068a452b_25)] [added: [PROPERTIES](#if966a1efad444c678cb814a4ff4d0758_25)] | | | [removed: [32](#i0700a8f6ea1f4171b75e8081068a452b_25)] [added: [34](#if966a1efad444c678cb814a4ff4d0758_25)] | | |
| [ITEM [removed: 3.](#i0700a8f6ea1f4171b75e8081068a452b_28)] [added: 3.](#if966a1efad444c678cb814a4ff4d0758_28)] | | | [LEGAL [removed: PROCEEDINGS](#i0700a8f6ea1f4171b75e8081068a452b_28)] [added: PROCEEDINGS](#if966a1efad444c678cb814a4ff4d0758_28)] | | | [removed: [32](#i0700a8f6ea1f4171b75e8081068a452b_28)] [added: [34](#if966a1efad444c678cb814a4ff4d0758_28)] | | |
| [ITEM [removed: 4.](#i0700a8f6ea1f4171b75e8081068a452b_31)] [added: 4.](#if966a1efad444c678cb814a4ff4d0758_31)] | | | [MINE SAFETY [removed: DISCLOSURES](#i0700a8f6ea1f4171b75e8081068a452b_31)] [added: DISCLOSURES](#if966a1efad444c678cb814a4ff4d0758_31)] | | | [removed: [32](#i0700a8f6ea1f4171b75e8081068a452b_31)] [added: [34](#if966a1efad444c678cb814a4ff4d0758_31)] | | |
| [ITEM [removed: 5.](#i0700a8f6ea1f4171b75e8081068a452b_37)] [added: 5.](#if966a1efad444c678cb814a4ff4d0758_37)] | | | [MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#i0700a8f6ea1f4171b75e8081068a452b_37)] [added: SECURITIES](#if966a1efad444c678cb814a4ff4d0758_37)] | | | [removed: [33](#i0700a8f6ea1f4171b75e8081068a452b_37)] [added: [35](#if966a1efad444c678cb814a4ff4d0758_37)] | | |
| [ITEM [removed: 6.](#i0700a8f6ea1f4171b75e8081068a452b_40)] [added: 6.](#if966a1efad444c678cb814a4ff4d0758_40)] | | | [removed: [RESERVED](#i0700a8f6ea1f4171b75e8081068a452b_40)] [added: [RESERVED](#if966a1efad444c678cb814a4ff4d0758_40)] | | | [removed: [35](#i0700a8f6ea1f4171b75e8081068a452b_40)] [added: [37](#if966a1efad444c678cb814a4ff4d0758_40)] | | |
| [ITEM [removed: 7.](#i0700a8f6ea1f4171b75e8081068a452b_43)] [added: 7.](#if966a1efad444c678cb814a4ff4d0758_43)] | | | [MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#i0700a8f6ea1f4171b75e8081068a452b_43)] [added: OPERATIONS](#if966a1efad444c678cb814a4ff4d0758_43)] | | | [removed: [36](#i0700a8f6ea1f4171b75e8081068a452b_43)] [added: [38](#if966a1efad444c678cb814a4ff4d0758_43)] | | |
| [ITEM [removed: 7A.](#i0700a8f6ea1f4171b75e8081068a452b_70)] [added: 7A.](#if966a1efad444c678cb814a4ff4d0758_73)] | | | [QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#i0700a8f6ea1f4171b75e8081068a452b_70)] [added: RISK](#if966a1efad444c678cb814a4ff4d0758_73)] | | | [removed: [62](#i0700a8f6ea1f4171b75e8081068a452b_70)] [added: [63](#if966a1efad444c678cb814a4ff4d0758_73)] | | |
| [ITEM [removed: 8.](#i0700a8f6ea1f4171b75e8081068a452b_76)] [added: 8.](#if966a1efad444c678cb814a4ff4d0758_79)] | | | [FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#i0700a8f6ea1f4171b75e8081068a452b_76)] [added: DATA](#if966a1efad444c678cb814a4ff4d0758_79)] | | | [removed: [65](#i0700a8f6ea1f4171b75e8081068a452b_76)] [added: [66](#if966a1efad444c678cb814a4ff4d0758_79)] | | |
| [ITEM [removed: 9.](#i0700a8f6ea1f4171b75e8081068a452b_166)] [added: 9.](#if966a1efad444c678cb814a4ff4d0758_172)] | | | [CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#i0700a8f6ea1f4171b75e8081068a452b_166)] [added: DISCLOSURE](#if966a1efad444c678cb814a4ff4d0758_172)] | | | [removed: [123](#i0700a8f6ea1f4171b75e8081068a452b_166)] [added: [120](#if966a1efad444c678cb814a4ff4d0758_172)] | | |
| [ITEM [removed: 9A.](#i0700a8f6ea1f4171b75e8081068a452b_169)] [added: 9A.](#if966a1efad444c678cb814a4ff4d0758_175)] | | | [CONTROLS AND [removed: PROCEDURES](#i0700a8f6ea1f4171b75e8081068a452b_169)] [added: PROCEDURES](#if966a1efad444c678cb814a4ff4d0758_175)] | | | [removed: [123](#i0700a8f6ea1f4171b75e8081068a452b_169)] [added: [120](#if966a1efad444c678cb814a4ff4d0758_175)] | | |
| [ITEM [removed: 9B.](#i0700a8f6ea1f4171b75e8081068a452b_172)] [added: 9B.](#if966a1efad444c678cb814a4ff4d0758_178)] | | | [OTHER [removed: INFORMATION](#i0700a8f6ea1f4171b75e8081068a452b_172)] [added: INFORMATION](#if966a1efad444c678cb814a4ff4d0758_178)] | | | [removed: [123](#i0700a8f6ea1f4171b75e8081068a452b_172)] [added: [120](#if966a1efad444c678cb814a4ff4d0758_178)] | | |
| [ITEM [removed: 9C.](#i0700a8f6ea1f4171b75e8081068a452b_175)] [added: 9C.](#if966a1efad444c678cb814a4ff4d0758_181)] | | | [DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT [removed: INSPECTIONS](#i0700a8f6ea1f4171b75e8081068a452b_175)] [added: INSPECTIONS](#if966a1efad444c678cb814a4ff4d0758_181)] | | | [removed: [124](#i0700a8f6ea1f4171b75e8081068a452b_175)] [added: [121](#if966a1efad444c678cb814a4ff4d0758_181)] | | |
| [ITEM [removed: 10.](#i0700a8f6ea1f4171b75e8081068a452b_181)] [added: 10.](#if966a1efad444c678cb814a4ff4d0758_187)] | | | [DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#i0700a8f6ea1f4171b75e8081068a452b_181)] [added: GOVERNANCE](#if966a1efad444c678cb814a4ff4d0758_187)] | | | [removed: [125](#i0700a8f6ea1f4171b75e8081068a452b_181)] [added: [122](#if966a1efad444c678cb814a4ff4d0758_187)] | | |
| [ITEM [removed: 11.](#i0700a8f6ea1f4171b75e8081068a452b_184)] [added: 11.](#if966a1efad444c678cb814a4ff4d0758_190)] | | | [EXECUTIVE [removed: COMPENSATION](#i0700a8f6ea1f4171b75e8081068a452b_184)] [added: COMPENSATION](#if966a1efad444c678cb814a4ff4d0758_190)] | | | [removed: [125](#i0700a8f6ea1f4171b75e8081068a452b_184)] [added: [122](#if966a1efad444c678cb814a4ff4d0758_190)] | | |
| [ITEM [removed: 12.](#i0700a8f6ea1f4171b75e8081068a452b_187)] [added: 12.](#if966a1efad444c678cb814a4ff4d0758_193)] | | | [SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#i0700a8f6ea1f4171b75e8081068a452b_187)] [added: MATTERS](#if966a1efad444c678cb814a4ff4d0758_193)] | | | [removed: [125](#i0700a8f6ea1f4171b75e8081068a452b_187)] [added: [122](#if966a1efad444c678cb814a4ff4d0758_193)] | | |
| [ITEM [removed: 13.](#i0700a8f6ea1f4171b75e8081068a452b_190)] [added: 13.](#if966a1efad444c678cb814a4ff4d0758_196)] | | | [CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR [removed: INDEPENDENCE](#i0700a8f6ea1f4171b75e8081068a452b_190)] [added: INDEPENDENCE](#if966a1efad444c678cb814a4ff4d0758_196)] | | | [removed: [125](#i0700a8f6ea1f4171b75e8081068a452b_190)] [added: [122](#if966a1efad444c678cb814a4ff4d0758_196)] | | |
| [ITEM [removed: 14.](#i0700a8f6ea1f4171b75e8081068a452b_193)] [added: 14.](#if966a1efad444c678cb814a4ff4d0758_199)] | | | [PRINCIPAL ACCOUNTANT FEES AND [removed: SERVICES](#i0700a8f6ea1f4171b75e8081068a452b_193)] [added: SERVICES](#if966a1efad444c678cb814a4ff4d0758_199)] | | | [removed: [125](#i0700a8f6ea1f4171b75e8081068a452b_193)] [added: [122](#if966a1efad444c678cb814a4ff4d0758_199)] | | |
| [ITEM [removed: 15.](#i0700a8f6ea1f4171b75e8081068a452b_199)] [added: 15.](#if966a1efad444c678cb814a4ff4d0758_205)] | | | [EXHIBITS AND FINANCIAL STATEMENT [removed: SCHEDULES](#i0700a8f6ea1f4171b75e8081068a452b_199)] [added: SCHEDULES](#if966a1efad444c678cb814a4ff4d0758_205)] | | | [removed: [126](#i0700a8f6ea1f4171b75e8081068a452b_199)] [added: [123](#if966a1efad444c678cb814a4ff4d0758_205)] | | |
| [ITEM [removed: 16.](#i0700a8f6ea1f4171b75e8081068a452b_202)] [added: 16.](#if966a1efad444c678cb814a4ff4d0758_208)] | | | [FORM 10-K [removed: SUMMARY](#i0700a8f6ea1f4171b75e8081068a452b_202)] [added: SUMMARY](#if966a1efad444c678cb814a4ff4d0758_208)] | | | [removed: [135](#i0700a8f6ea1f4171b75e8081068a452b_202)] [added: [133](#if966a1efad444c678cb814a4ff4d0758_208)] | | |
| [PART I](#if966a1efad444c678cb814a4ff4d0758_13) | | | | | | [3](#if966a1efad444c678cb814a4ff4d0758_13) | | |
| [ITEM 1C.](#if966a1efad444c678cb814a4ff4d0758_1909) | | | [CYBERSECURITY](#if966a1efad444c678cb814a4ff4d0758_1909) | | | [33](#if966a1efad444c678cb814a4ff4d0758_22) | | |
| [PART II](#if966a1efad444c678cb814a4ff4d0758_34) | | | | | | [35](#if966a1efad444c678cb814a4ff4d0758_34) | | |
| [PART III](#if966a1efad444c678cb814a4ff4d0758_184) | | | | | | [122](#if966a1efad444c678cb814a4ff4d0758_184) | | |
| [PART IV](#if966a1efad444c678cb814a4ff4d0758_202) | | | | | | [123](#if966a1efad444c678cb814a4ff4d0758_202) | | |
| [SIGNATURES](#if966a1efad444c678cb814a4ff4d0758_211) | | | | | | [134](#if966a1efad444c678cb814a4ff4d0758_211) | | |
| 5.50% Mandatory Convertible Preferred Stock, Series A, par value $0.01 per share | | | | | | BSX PR A | | | | | | New York Stock Exchange | | |
| [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) | | |
Item 1C. CYBERSECURITY
0 rewritten, 38 added, 0 removed, 0 unchanged
New section this year
We rely on information technology (IT) and operational technology (OT) systems, including technology from third party vendors, to manufacture and ship our products, as well as to process, transmit and store electronic information in our day-to-day operations.
We have established a security program and processes to assess, identify and manage cybersecurity risks related to our IT and OT systems, as well as our products.
Our global cybersecurity organization is led by our chief information security officer (CISO), who reports directly to our chief information officer (CIO) and under the organization of our chief information and digital officer (CIDO).
Our current CISO has extensive information technology experience, including in security architecture, software development and engineering, as well as leading security operations and incident response, offensive and defensive cyber projects in increasing roles of responsibility.
He also previously held Certified Information Systems Security Professional (CISSP) and GIAC Certified Forensics Analyst certifications.
Our current CIDO has extensive experience overseeing information technology and security programs, including roles of increasing leadership within our Information and Digital organizations over the last ten years, and prior to that in increasing roles of responsibility managing information systems, including over 18 years at General Electric.
Our current CIDO holds CISSP and other IT certifications.
Our enterprise cybersecurity program is designed to monitor and continually enhance our enterprise security posture, with the goal of preventing cybersecurity incidents to the extent feasible, including assessments to better understand our readiness for cybersecurity threats and the resilience of our critical business functions, with the goal of avoiding or reducing the impact if such an event were to occur.
We have implemented cybersecurity policies mapped to industry and government standards and frameworks, such as U.S. National Institute of Standards and Technology (NIST) and International Standard of Organization (ISO).
Our cybersecurity strategy and maturity is aligned to the NIST-Cybersecurity Framework (NIST CSF).
This framework provides us a structured approach to managing our cybersecurity risk through its five core functions: Identification of digital assets, their risks, and business context; Protection, by implementing safeguards such as firewalls, network segmentation, and email security; Detection: through monitoring for anomalies and potential threats on the network, endpoints and data; Response, by having up to date incident response plans and skilled teams in place, including utilizing a crisis committee to respond in the event of a cybersecurity incident; and Recovery, achieved through ensuring data and system backups as well as testing our disaster recovery procedures.
We also regularly review our cybersecurity policies and require annual cybersecurity training for our employees.
Our product cybersecurity focus begins with our design protocols and is supported by quality testing, provider education, and packaging and distribution standards.
We use penetration testing to simulate cyberattacks and better understand our exploitable weaknesses, and we monitor threat intelligence feeds, including avenues for product users to report vulnerabilities directly to us, and use scanning tools to detect and assess vulnerabilities that could affect our products.
In addition, we conduct product, enterprise and vendor/third party risk assessments, vulnerability assessments and analyses to gain insights into potential vulnerabilities and their impact on critical functions, and leverage their outcomes to prioritize our security investments and balance our resource allocation.
We use third party security providers for specialized areas such as incident response, penetration testing, and on-demand cybersecurity services, including staff augmentation and consulting.
We also leverage a managed security service provider to augment our cybersecurity organization and to provide additional monitoring and response capabilities.
We engage and rely upon third parties to provide services and/or goods, represent and or otherwise act on our behalf.
Prior to engaging or conducting any business with or on our behalf, such parties undergo a due diligence review, and a third party security risk assessment is conducted to validate they are legally permitted and qualified to maintain appropriate safeguards to protect our information assets in connection with the services they intend to provide.
Assessing, identifying, and managing cybersecurity related risks are integrated into our enterprise risk management (ERM) program.
Cybersecurity related risks are included in the risk universe that the ERM function evaluates to assess top risks to the Company on an annual basis.
Risks are discussed with appropriate members of management, who manage risk coverage, monitoring and reporting in the relevant risk function, including our cybersecurity program, and incorporate those activities as part of developing our strategic plan.
The ERM program’s annual risk assessment is presented annually to our Board of Directors and the Risk Committee of the Board.
Our Board of Directors oversees an enterprise-wide approach to risk management, including cybersecurity risks.
While the Board has the ultimate responsibility for risk oversight, each committee of the Board also oversees risk to the extent it relates to the committee’s responsibilities and provides reports to the Board in its respective area of responsibility.
The Risk Committee
of our Board also focuses on an enterprise-wide approach to risk management, and has primary oversight responsibility for areas of quality and nonfinancial compliance issues, including cybersecurity risks.
The Risk Committee receives periodic updates from the CISO and CIDO on our cyber risks and threats, assessments of our cybersecurity program and the evolving threat landscape.
Our Board of Directors also receives annual updates on such cybersecurity matters, or more frequently as appropriate under the procedures described below.
Our Board and Risk Committee also receive cybersecurity risk assessments as part of the annual ERM program presentation described above.
We have established controls and procedures to escalate enterprise level issues, including cybersecurity matters, to the appropriate management levels within our organization and our Board of Directors, or members or committees thereof, as appropriate.
Under our framework, cybersecurity issues, including those involving vulnerabilities introduced by our use of third-party software, are analyzed by subject matter experts, including a crisis committee as needed in accordance with our incident response plans, for potential financial, operational, and reputational risks, based on, among other factors, the nature of the matter and breadth of impact.
Matters determined to present potential material impacts to our financial results, operations, and/or reputation are immediately reported by management to the Board of Directors, or individual members or committees thereof, as appropriate, in accordance with our established escalation framework.
In addition, we have established procedures to help ensure that members of management responsible for overseeing the effectiveness of disclosure controls are informed in a timely manner of known cybersecurity risks and incidents that may materially impact our operations and that timely public disclosure is made, as appropriate.
Based on the information available as of the date of this Annual Report on Form 10-K, we are not aware of any risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, that have materially affected or are reasonably likely to materially affect us, including our business strategy, results of operations, or financial condition.
Despite our security measures, however, there can be no assurance that we, or the third parties with which we interact, will not experience a cybersecurity incident in the future that may materially affect us.
For additional information, see Item 1A.
“Risk Factors” for a discussion of cybersecurity risks that we face.
Item 2. PROPERTIES
2 rewritten, 3 added, 3 removed, 8 unchanged
As of December 31, [removed: 2022,] [added: 2023,] we maintained 15 principal manufacturing facilities, including eight in the U.S. and Puerto Rico, three in Ireland, two in Costa Rica, one in Malaysia, [removed: and] one in Brazil, as well as [added: a Global Headquarters in the U.S. and] various distribution and technology centers around the world.
The following is a summary of our facilities as of December 31, [removed: 2022] [added: 2023] (in approximate square feet):
| U.S. | | | 4,264,041 | | | | | | 1,904,898 | | | | | | 6,168,939 | | |
| International | | | 2,928,410 | | | | | | 2,088,089 | | | | | | 5,016,499 | | |
| | | | 7,192,451 | | | | | | 3,992,987 | | | | | | 11,185,438 | | |
| 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 | | |
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
10 rewritten, 0 added, 0 removed, 12 unchanged
As of January 31, [removed: 2023,] [added: 2024,] there were [removed: 5,752] [added: 5,432] holders of record of our common stock.
We did not pay a cash dividend in [removed: 2022, 2021] [added: 2023, 2022] or [removed: 2020] [added: 2021] on our common stock and currently we do not intend to pay cash dividends on our common stock.
[removed: "Security] [added: Security] Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters"] [added: Matters] under Part III of this Annual Report on Form 10-K for information on where to find information required by Item 201(d) of Regulation S-K.
On December 14, 2020, our Board of Directors approved, and we announced, a [removed: new] stock repurchase program authorizing the repurchase of up to $1.000 billion of our common stock (2020 Share Repurchase Program).
We made no share repurchases in [removed: 2022] [added: 2023] or [removed: 2021] [added: 2022] and, as of December 31, [removed: 2022,] [added: 2023,] had the full $1.000 billion remaining available under the 2020 Share Repurchase Program.
Refer to [removed: Note] [added: *Note] J – Stockholders' [removed: Equity] [added: Equity*] to our consolidated financial statements [removed: contained] [added: included] in Item 8.
There were no purchases of equity securities by the issuer or affiliated purchases in the fourth quarter of [removed: 2022,] [added: 2023,] required to be reported here.
The graph below compares the five-year total return to stockholders on our common stock with the return of the Standard & Poor’s (S&P) 500 Stock Index and the S&P [removed: Healthcare] [added: Health Care] Equipment Index.
The graph assumes $100 was invested in our common stock and in each of the named indices on December 31, [removed: 2017] [added: 2018] and that any dividends were reinvested.
[removed: ][added: ]
Item 6. RESERVED
0 rewritten, 0 added, 1 removed, 0 unchanged
Not applicable.
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
713 rewritten, 354 added, 281 removed, 1,027 unchanged
| *(in millions, except per share data)* | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |
| Net sales | | | $ | [removed: 12,682] [added: 14,240] | | | | | $ | [removed: 11,888] [added: 12,682] | | | | | $ | [removed: 9,913] [added: 11,888] | |
| Cost of products sold | | | [removed: 3,956] [added: 4,345] | | | | | | [removed: 3,711] [added: 3,956] | | | | | | [removed: 3,465] [added: 3,711] | | |
| Gross profit | | | [removed: 8,727] [added: 9,896] | | | | | | [removed: 8,177] [added: 8,727] | | | | | | [removed: 6,448] [added: 8,177] | | |
| Selling, general and administrative expenses | | | [removed: 4,520] [added: 5,190] | | | | | | [removed: 4,359] [added: 4,520] | | | | | | [removed: 3,787] [added: 4,359] | | |
| Research and development expenses | | | [removed: 1,323] [added: 1,414] | | | | | | [removed: 1,204] [added: 1,323] | | | | | | [removed: 1,143] [added: 1,204] | | |
| Royalty expense | | | [removed: 47] [added: 46] | | | | | | [removed: 49] [added: 47] | | | | | | [removed: 45] [added: 49] | | |
| Amortization expense | | | [removed: 803] [added: 828] | | | | | | [removed: 741] [added: 803] | | | | | | [removed: 789] [added: 741] | | |
| Intangible asset impairment charges | | | [removed: 132] [added: 58] | | | | | | [removed: 370] [added: 132] | | | | | | [removed: 460] [added: 370] | | |
| Contingent consideration net expense (benefit) | | | [removed: 35] [added: 58] | | | | | | [removed: (136)] [added: 35] | | | | | | [removed: (100)] [added: (136)] | | |
| Restructuring net charges (credits) | | | [removed: 24] [added: 69] | | | | | | [removed: 40] [added: 24] | | | | | | [removed: 52] [added: 40] | | |
| Litigation-related net charges (credits) | | | [removed: 173] [added: (111)] | | | | | | [removed: 430] [added: 173] | | | | | | [removed: 278] [added: 430] | | |
| Loss (gain) on disposal of businesses and assets | | | [removed: 22] [added: —] | | | | | | [removed: (78)] [added: 22] | | | | | | [removed: —] [added: (78)] | | |
| | | | [removed: 7,078] [added: 7,553] | | | | | | [removed: 6,978] [added: 7,078] | | | | | | [removed: 6,528] [added: 6,978] | | |
| Operating income (loss) | | | [removed: 1,649] [added: 2,343] | | | | | | [removed: 1,199] [added: 1,649] | | | | | | [removed: (80)] [added: 1,199] | | |
| Interest expense | | | [removed: (470)] [added: (265)] | | | | | | [removed: (341)] [added: (470)] | | | | | | [removed: (361)] [added: (341)] | | |
| Other, net | | | [removed: (38)] [added: (93)] | | | | | | [removed: 218] [added: (38)] | | | | | | [removed: 362] [added: 218] | | |
| Income (loss) before income taxes | | | [removed: 1,141] [added: 1,985] | | | | | | [removed: 1,076] [added: 1,141] | | | | | | [removed: (79)] [added: 1,076] | | |
| Income tax expense (benefit) | | | [removed: 443] [added: 393] | | | | | | [removed: 36] [added: 443] | | | | | | [removed: 2] [added: 36] | | |
| Net income (loss) | | | [removed: 698] [added: 1,592] | | | | | | [removed: 1,041] [added: 698] | | | | | | [removed: (82)] [added: 1,041] | | |
| Preferred stock dividends | | | [removed: (55)] [added: (23)] | | | | | | (55) | | | | | | [removed: (33)] [added: (55)] | | |
| Net income (loss) [removed: available] [added: attributable] to [added: Boston Scientific] common stockholders | | | $ | [removed: 642] [added: 1,570] | | | | | $ | [removed: 985] [added: 642] | | | | | $ | [removed: (115)] [added: 985] | |
| Net income (loss) per common share — basic | | | $ | [removed: 0.45] [added: 1.08] | | | | | $ | [removed: 0.69] [added: 0.45] | | | | | $ | [removed: (0.08)] [added: 0.69] | |
| Net income (loss) per common share — [removed: assuming dilution] [added: diluted] | | | $ | [removed: 0.45] [added: 1.07] | | | | | $ | [removed: 0.69] [added: 0.45] | | | | | $ | [removed: (0.08)] [added: 0.69] | |
| Basic | | | [removed: 1,430.5] [added: 1,453.0] | | | | | | [removed: 1,422.3] [added: 1,430.5] | | | | | | [removed: 1,416.7] [added: 1,422.3] | | |
| *(in millions)* | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |
| Net income (loss) | | | $ | [removed: 698] [added: 1,592] | | | | | $ | [removed: 1,041] [added: 698] | | | | | $ | [removed: (82)] [added: 1,041] | |
| Foreign currency translation adjustment | | | [removed: (94)] [added: (95)] | | | | | | [removed: (125)] [added: (94)] | | | | | | [removed: 76] [added: (125)] | | |
| Net change in derivative financial instruments | | | [removed: 63] [added: (115)] | | | | | | [removed: 170] [added: 63] | | | | | | [removed: (137)] [added: 170] | | |
| Net change in defined benefit pensions and other items | | | [removed: 37] [added: (9)] | | | | | | [removed: 11] [added: 37] | | | | | | [removed: (1)] [added: 11] | | |
| Total other comprehensive income (loss) | | | [removed: 6] [added: (95)] | | | | | | [removed: 56] [added: (115)] | | | | | | [removed: (63)] | | | [added: | | | (9) | | | | | | (219) | | |]
| [removed: Total comprehensive] [added: Comprehensive] income (loss) | | | $ | [removed: 704] [added: 1,362] | | | | | $ | [removed: 1,096] [added: 704] | | | | | $ | [removed: (145)] [added: 1,096] | |
| *(in millions, except share and per share data)* | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |
| [removed: Cash] [added: *Cash] and cash [removed: equivalents] [added: equivalents*] | | | $ | [added: 865 | | | | | $ |] 928 | | | | | $ | 1,925 | |
| Trade accounts receivable, net | | | [removed: 1,970] [added: 2,228] | | | | | | [removed: 1,778] [added: 1,970] | | |
| Inventories | | | [removed: 1,867] [added: 2,484] | | | | | | [removed: 1,610] [added: 1,867] | | |
| Prepaid income taxes | | | [removed: 264] [added: 315] | | | | | | [removed: 205] [added: 264] | | |
| Other current assets | | | [removed: 731] [added: 621] | | | | | | [removed: 799] [added: 731] | | |
| Total current assets | | | [removed: 5,760] [added: 6,514] | | | | | | [removed: 6,317] [added: 5,760] | | |
| Property, plant and equipment, net | | | [removed: 2,446] [added: 2,859] | | | | | | [removed: 2,252] [added: 2,446] | | |
| Net income (loss) attributable to noncontrolling interests | | | (1) | | | | | | — | | | | | | — | | |
| Diluted | | | 1,463.5 | | | | | | 1,439.7 | | | | | | 1,433.8 | | |
Amounts may not foot due to rounding.
| Foreign currency translation adjustment | | | (105) | | | | | | (94) | | | | | | (125) | | |
| Comprehensive income (loss) attributable to noncontrolling interests | | | (11) | | | | | | — | | | | | | — | | |
| Comprehensive income attributable to Boston Scientific common stockholders | | | $ | 1,373 | | | | | $ | 704 | | | | | $ | 1,096 | |
Amounts may not foot due to rounding.
| Noncontrolling interests | | | 248 | | | | | | — | | |
| Total equity | | | 19,530 | | | | | | 17,573 | | |
Amounts may not foot due to rounding.
| Conversion of mandatory convertible preferred stock to common stock | | | 23,982,902 | | | | | | — | | | | | | — | | |
| Conversion of mandatory convertible preferred stock to common stock | | | (0) | | | | | | — | | | | | | — | | |
| Conversion of mandatory convertible preferred stock to common stock | | | 0 | | | | | | — | | | | | | — | | |
| Conversion of mandatory convertible preferred stock to common stock | | | (0) | | | | | | — | | | | | | — | | |
| Net (income) loss attributable to noncontrolling interests | | | 1 | | | | | | — | | | | | | — | | |
| Noncontrolling interests | | | | | | | | | | | | | | | | | |
| Beginning | | | $ | — | | | | | $ | — | | | | | $ | — | |
| Changes to noncontrolling ownership interest | | | 259 | | | | | | — | | | | | | — | | |
| Net income (loss) attributable to noncontrolling interests | | | (1) | | | | | | — | | | | | | — | | |
| Changes in other comprehensive income (loss) | | | (10) | | | | | | — | | | | | | — | | |
| Ending | | | $ | 248 | | | | | $ | — | | | | | $ | — | |
| Total equity | | | $ | 19,530 | | | | | $ | 17,573 | | | | | $ | 16,622 | |
Amounts may not foot due to rounding.
| Net income (loss) | | | $ | 1,592 | | | | | $ | 698 | | | | | $ | 1,041 | |
| Loss (gain) on disposal of businesses and assets | | | — | | | | | | 22 | | | | | | (78) | | |
Amounts may not foot due to rounding.
| *(in millions)* | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |
| Cash, cash equivalents, restricted cash and restricted cash equivalents at end of period | | | $ | 1,055 | | | | | $ | 1,126 | | | | | $ | 2,168 | |
Amounts may not foot due to rounding.
All intercompany balances and transactions have been eliminated in consolidation.
recoverability.
In performing annual impairment assessments, the qualitative approach is used for testing reporting units where fair value has historically exceeded carrying value by greater than 100 percent, and all other reporting units are tested using the quantitative approach.
When a quantitative test is performed, we typically use the income approach, specifically the Discounted Cash Flow method, to derive the fair value of each of our reporting units in preparing our goodwill impairment assessments.
We historically selected this method as being the most meaningful in preparing our goodwill assessments because we believe the income approach most appropriately measures the fair value of our income producing assets.
We make assumptions about the amount and timing of future expected cash flows, terminal value growth rates and appropriate discount rates.
The amount and timing of future cash flows within our Discounted Cash Flow analysis is based on our most recent operational budgets, long range strategic plans and other estimates.
investee’s ability to continue as a going concern.
We recorded *Restructuring net charges (credits)* of $69 million in 2023, $24 million in 2022 and $40 million in 2021.
The restructuring reserve balance as of December 31, 2023 and 2022 was $41 million and $10 million, respectively.
On January 8, 2024, we announced our entry into a definitive agreement to acquire 100 percent of Axonics, Inc. (Axonics), a publicly traded medical technology company primarily focused on the development and commercialization of devices to treat urinary and bowel dysfunction.
| Goodwill impairment charges | | | — | | | | | | — | | | | | | 73 | | |
| Assuming dilution | | | 1,439.7 | | | | | | 1,433.8 | | | | | | 1,416.7 | | |
| Common stock issuance | | | — | | | | | | — | | | | | | 29,382,500 | | |
| Repurchase of common stock | | | — | | | | | | — | | | | | | (535) | | |
| Preferred stock issuance | | | — | | | | | | — | | | | | | 975 | | |
| Common stock issuance | | | — | | | | | | — | | | | | | 975 | | |
| Cumulative effect adjustment for adoption of ASU 2016-13 | | | — | | | | | | — | | | | | | (10) | | |
| Payments on borrowings from credit facilities | | | — | | | | | | — | | | | | | (1,919) | | |
| Proceeds from borrowings on credit facilities | | | — | | | | | | — | | | | | | 1,916 | | |
| Proceeds from long-term borrowings, net of debt issuance costs | | | 3,270 | | | | | | — | | | | | | 1,683 | | |
| Cash dividends paid on preferred stock | | | (55) | | | | | | (55) | | | | | | (28) | | |
| Net proceeds from issuance of preferred stock in connection with public offering | | | — | | | | | | — | | | | | | 975 | | |
| Net proceeds from issuance of common stock in connection with public offering | | | — | | | | | | — | | | | | | 975 | | |
| Payments for repurchase of common stock | | | — | | | | | | — | | | | | | (535) | | |
customer payments collected by us for servicing previously sold customer receivables to the purchaser.
liability equal to these estimated costs as cost of products sold at the time the product sale occurs.
During 2020, we recorded $149 million of abnormal manufacturing variances attributable to lower production levels resulting from the COVID-19 pandemic and lower than forecasted demand for our products.
The primary basis for determining the technological
We
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.
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.
| | | | | | | | | | | | | | | | | | | | | |
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| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Goodwill | | | $ | 988 | | | | | | | | | | | | | | | | | | | |
2021 Acquisitions
On March 1, 2021, we completed our acquisition of Preventice Solutions, Inc. (Preventice), a privately-held company with a full portfolio of mobile cardiac health solutions and services, ranging from ambulatory cardiac monitors, to cardiac event monitors and mobile cardiac telemetry.
The transaction consisted of an upfront cash payment of $925 million and up to an additional $300 million in a potential commercial milestone payment.
We had been an investor in Preventice since 2015 and held an equity stake of approximately 22 percent immediately prior to the acquisition date.
We remeasured the fair value of our previously-held investment based on the allocation of the purchase price according to priority of equity interests, which resulted in a $196 million gain recognized within *Other, net*.
The transaction price for the remaining stake consisted of an upfront cash payment of $706 million, net of cash acquired, and an additional revenue-based milestone payment of $216 million made during the second quarter of 2022.
On August 6, 2021, we completed our acquisition of the remaining shares of Farapulse, Inc. (Farapulse), a privately-held company that developed a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias.
The transaction consisted of an upfront cash payment of $450 million, up to $125 million upon achievement of certain clinical and regulatory milestones and additional revenue-based payments over the next three years.
We had been an investor in Farapulse since 2014 and held an equity stake of approximately 27 percent immediately prior to the acquisition date.
We remeasured the fair value of our previously-held investment based on the allocation of the purchase price according to priority of equity interests which resulted in a $222 million gain recognized within *Other, net*.
The transaction price for the remaining stake consisted of an upfront cash payment of $268 million, net of cash acquired, up to $92 million in additional clinical and regulatory milestone payments, as well as future revenue-based payments.
An excerpt. Shown here: 40 of 713 rewritten, 40 of 354 added and 40 of 281 removed. The counts are complete. For every sentence, read Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA in the FY2023 filing and the FY2022 filing.
Item 9A. CONTROLS AND PROCEDURES
4 rewritten, 4 added, 3 removed, 7 unchanged
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: 2022] [added: 2023] 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: 2022,] [added: 2023,] our disclosure controls and procedures were effective.
Management’s annual report on our internal control over financial reporting is [removed: contained] [added: included] in Item [removed: 7 of this Annual Report on Form 10-K.][added: 7.]
The report of Ernst & Young LLP on our internal control over financial reporting is [removed: contained] [added: included] in Item [removed: 7 of this Annual Report on Form 10-K.][added: 7.]
Management's Discussion and Analysis of Financial Condition and Results of Operations of this Annual Report on Form 10-K.
Management's Discussion and Analysis of Financial Condition and Results of Operations of this Annual Report on Form 10-K.
The portion of the transition to the new ERP system which we have completed to date resulted in changes in our internal control over financial reporting during the year ended December 31, 2023.
As future phases are implemented, we expect the changes to have a material impact on our internal controls over financial reporting and we will evaluate whether these process changes necessitate further changes in the design of and testing for effectiveness of internal controls over financial reporting.
During the quarter ended December 31, 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.
As the phased implementation occurs, it may result in changes to our processes and procedures which may result in changes to our internal controls over financial reporting.
As such changes occur, we will evaluate quarterly whether they materially affect our internal control over financial reporting.
Item 9B. OTHER INFORMATION
0 rewritten, 13 added, 22 removed, 0 unchanged
On November 6, 2023, John Bradley Sorenson, our Executive Vice President, Global Operations, entered into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c).
Mr. Sorenson’s plan covers the sale of 33,938 shares of our common stock to be acquired upon the exercise of stock options.
Transactions under Mr. Sorenson’s plan are based upon pre-established dates and stock price thresholds and will only occur upon the expiration of the applicable mandatory cooling-off period.
Mr. Sorenson’s plan will terminate on the earlier of December 31, 2024 or the date all shares subject to the plan have been sold.
On November 17, 2023, Wendy Carruthers, our Executive Vice President, Human Resources, entered into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c).
Ms. Carruthers’ plan covers the sale of 76,113 shares of our common stock, including 46,893 shares to be acquired upon the exercise of stock options.
Transactions under Ms. Carruthers’ plan are based upon pre-established dates and stock price thresholds and will only occur upon the expiration of the applicable mandatory cooling-off period.
Ms. Carruthers’ plan will terminate on the earlier of December 31, 2024 or the date all shares subject to the plan have been sold.
On November 22, 2023, Arthur Butcher, our Executive Vice President and Group President, MedSurg and Asia Pacific, entered into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c).
Mr. Butcher’s plan covers the sale of up to 77,687 shares of our common stock, including up to 54,514 shares to be acquired upon determination and/or vesting of performance share units and restricted share units, and 16,742 shares to be acquired upon the exercise of stock options.
Transactions under Mr. Butcher’s plan are based upon pre-established dates and stock price thresholds and will only occur upon
the expiration of the applicable mandatory cooling-off period.
Mr. Butcher’s plan will terminate on the earlier of January 31, 2025 or the date all shares subject to the plan have been sold.
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.
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item is set forth in our Proxy Statement for the [removed: 2023] [added: 2024] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2022] [added: 2023] and is incorporated into this Annual Report on Form 10-K by reference.
Item 11. EXECUTIVE COMPENSATION
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item is set forth in our Proxy Statement for the [removed: 2023] [added: 2024] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2022] [added: 2023] and is incorporated into this Annual Report on Form 10-K by reference.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item is set forth in our Proxy Statement for the [removed: 2023] [added: 2024] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2022] [added: 2023] and is incorporated into this Annual Report on Form 10-K by reference.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item is set forth in our Proxy Statement for the [removed: 2023] [added: 2024] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2022] [added: 2023] and is incorporated into this Annual Report on Form 10-K by reference.
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
1 rewritten, 0 added, 0 removed, 2 unchanged
The information required by this Item is set forth in our Proxy Statement for the [removed: 2023] [added: 2024] Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, [removed: 2022] [added: 2023] and is incorporated into this Annual Report on Form 10-K by reference.
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
53 rewritten, 18 added, 1 removed, 231 unchanged
| 4.6 | | | | | | [Second Supplemental Indenture dated as of April [removed: 26,] [added: 21,] 2006 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 99.6 to the Company's Current Report on Form 8-K filed on April 26, 2006, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000110465906027974/a06-8189_4ex99d6.htm) | | |
| 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 4.1 to the [removed: 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] [added: Company's] Registration Statement on Form S-3, File No 333-188918.](http://www.sec.gov/Archives/edgar/data/885725/000104746913006559/a2215392zex-4_1.htm) | | |
| 10.8 | | | | | | [Form of Restricted Stock Award Agreement (Non-Employee Directors) under the Company's 2011 Long-Term Incentive Plan (incorporated herein by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, as filed August 7, [removed: 2012.] [added: 2012,] File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572512000029/exhibit101-q2201210xq.htm) | | |
| 10.19 | | | | | | [Form of Amendment, dated February 14, 2012, to Offer Letter dated September 6, 2011 between the Company and Michael F. Mahoney, as supplemented September 13, 2011 (incorporated herein by reference to Exhibit 10.100 to the Company's Annual Report on Form 10-K for the year ended December 31, [removed: 2011, filed] [added: 2011,](http://www.sec.gov/Archives/edgar/data/885725/000088572512000006/exhibit10100-mahoneyofferl.htm) [filed] on February 17, 2012, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572512000006/exhibit10100-mahoneyofferl.htm) | | |
| 10.22 | | | | | | [Boston Scientific Corporation Domestic Relocation Policy Tier 5 Executive Officer Homeowner, effective January 2007 [added: and updated July 2012] (incorporated herein by reference to Exhibit 10.118 to the Company's Annual Report on Form 10-K for the year ended December 31, 2012, filed on February 22, 2013, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572513000007/exhibit10118domesticreloca.htm) | | |
| 10.23 | | | | | | [Form of Letter to Key Management Personnel re: Change in Control Agreement (incorporated herein by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on March 6, 2013, File No. [removed: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000110465913017992/a13-6792_1ex10d1.htm)] [added: 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000110465913017992/a13-6792_1ex10d1.htm)] | | |
| 10.24 | | | | | | [Form of Offer Letter by and between the Company and Daniel J. Brennan, dated October 22, 2013 (incorporated herein by reference to Exhibit 10.2 to the Company's Current Report on Form 8-K [removed: as] filed [added: on] October 24, 2013 File No. [removed: 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000110465913077459/a13-22722_1ex10d2.htm)] [added: 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000110465913077459/a13-22722_1ex10d2.htm)] | | |
| 10.27 | | | | | | [Boston Scientific Corporation Non-Employee Director Deferred Compensation [removed: Plan of the Company,] [added: Plan,] as amended and restated, effective January 1, 2009 (incorporated herein by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on October 31, 2008, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000107261308001968/exhibit10-1_16156.htm) | | |
| [removed: 10.30] [added: 10.71] | | | | | | [Boston Scientific Corporation [removed: Executive Retirement] [added: 2022 Annual Bonus] Plan, [removed: as amended and restated] [added: Performance Period January 1 - December 31, 2022] effective [removed: August] [added: as of January] 1, [removed: 2016] [added: 2022] (incorporated herein by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on [removed: July 28, 2016,] [added: November 23, 2021,] File No. [removed: 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000110465916135014/a16-15337_1ex10d1.htm)] [added: 001-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572521000056/exhibit101bostonscientific.htm)] | | |
| 10.31 | | | | | | [Form of Non-Qualified Stock Option Agreement [added: (Non-Employee Directors)] under the Company's 2011 Long-Term Incentive Plan [removed: (Non-Employee Directors)] (incorporated herein by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed on November 5, 2014, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572514000030/exhibit101-formofnonxquali.htm) | | |
| 10.32 | | | | | | [Form of Restricted Stock Award Agreement [added: (Non-Employee Directors)] under the Company's 2011 Long-Term Incentive Plan [removed: (Non-Employee Directors)] (incorporated herein by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed on November 5, 2014, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572514000030/exhibit102-formofrestricte.htm) | | |
| 10.33 | | | | | | [Form of Deferred Stock Unit Award [removed: Agreement] [added: Agreement](http://www.sec.gov/Archives/edgar/data/885725/000088572514000030/exhibit103-formofdeferreds.htm) [(Non-Employee Directors)] under the [removed: Company's 2011] [added: Company's](http://www.sec.gov/Archives/edgar/data/885725/000088572514000030/exhibit103-formofdeferreds.htm) [2011] Long-Term Incentive Plan [removed: (Non-Employee Directors)] (incorporated herein by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed on November 5, 2014, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572514000030/exhibit103-formofdeferreds.htm) | | |
| 10.40 | | | | | | [Form of 2018 Global Deferred Stock Unit Award Agreement under the Company's 2011 Long-Term Incentive Plan (incorporated herein by reference to Exhibit 10.2 to the Company's Quarterly Report on [removed: Form 10-Q] [added: Form](http://www.sec.gov/Archives/edgar/data/885725/000088572518000021/exhibit102-formofdsuagreem.htm) [](http://www.sec.gov/Archives/edgar/data/885725/000088572518000021/exhibit102-formofdsuagreem.htm)[10-Q] for the quarter ended March 31, 2018, filed on May 1, [removed: 2018, File] [added: 2018,](http://www.sec.gov/Archives/edgar/data/885725/000088572518000021/exhibit102-formofdsuagreem.htm) [File] No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572518000021/exhibit102-formofdsuagreem.htm) | | |
| 10.43 | | | | | | [Form of 2018 Restricted Stock Award Agreement for Non-Employee Directors under the Company's 2011 Long-Term Incentive Plan [removed: incorporated] [added: (incorporated] herein by reference to Exhibit 10.7 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, filed on May 1, 2018, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572518000021/exhibit107-2018_rsaxawardx.htm) | | |
| [removed: 10.55*] [added: 10.55] | | | | | | [Form of 2020 Global Non-Qualified Stock Option Agreement under the Company's 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1055-2020grantxnqagreeme.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.55 to the Company's Annual Repo](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1055-2020grantxnqagreeme.htm)[r](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1055-2020grantxnqagreeme.htm)[t on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1055-2020grantxnqagreeme.htm)] | | |
| [removed: 10.56*] [added: 10.56] | | | | | | [Form of 2020 Global Restricted Stock Unit Award Agreement under the Company's 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1056-2020grantxrsuagreem.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.56 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1056-2020grantxrsuagreem.htm)] | | |
| [removed: 10.57*] [added: 10.57] | | | | | | [Form of 2020 Restricted Stock Award Agreement for Non-Employee Directors under the Company's 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1057-2020grantxrsabodawa.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.57 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1057-2020grantxrsabodawa.htm)] | | |
| [removed: 10.58*] [added: 10.58] | | | | | | [Form of 2020 Deferred Stock Unit Award Agreement for Non-Employee Directors under the Company's 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1058-2020grantxdsubodawa.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.58 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1058-2020grantxdsubodawa.htm)] | | |
| [removed: 10.60] [added: 2.1] | | | | | | [removed: [Underwriting Agreement, dated as] [added: [Agreement and Plan] of [removed: May 14, 2020, as supplemented by the Terms Agreement,] [added: Merger,] dated [removed: May 14, 2020, among Boston Scientific Corporation and Barclays Capital Inc., Citigroup Global Markets Inc., J.P. Morgan Securities LLC and Wells Fargo Securities, LLC,] as [removed: representatives] of [added: January 8, 2024, among] the [removed: underwriters.] [added: Company, Sadie Merger Sub, Inc. and Axonics, Inc.] (incorporated herein by reference to Exhibit [removed: 1.1] [added: 2.1] to the Company's Current Report on Form 8-K filed on [removed: May 18, 2020,] [added: January 8, 2024,] File No. [removed: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000094787120000487/ss173781_ex0101.htm)] [added: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572524000007/agreementandplanofmergerda.htm)] | | |
| 10.61 | | | | | | [removed: [Underwriting Agreement relating to the Common Stock, dated as of May 21, 2020, among Boston] [added: [Boston] Scientific Corporation [removed: and J.P. Morgan Securities LLC and BofA Securities Inc., as representatives of the underwriters.] [added: 2021 Free Cash Flow Performance Share Program, Performance Period January 1 - December 31, 2021] (incorporated herein by reference to Exhibit [removed: 1.1] [added: 10.3] to the Company's Current Report on Form 8-K filed on [removed: May 28,] [added: November 24,] 2020, File No. [removed: 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000094787120000519/ss174270_ex0101.htm)] [added: 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1032021freecash.htm)] | | |
| [removed: 10.63] [added: 10.60] | | | | | | [Boston Scientific Corporation 2021 Total Shareholder Return Performance Share Program, Performance Period January 1, 2021 - December 31, 2023 (incorporated herein by reference to Exhibit 10.2 to the Company's Current Report on Form 8-K filed on November 24, 2020, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1022021totalsha.htm) | | |
| [removed: 10.64] [added: 10.73] | | | | | | [Boston Scientific Corporation [removed: 2021] [added: 2022] Free Cash Flow Performance Share Program, Performance Period January 1 - December 31, [removed: 2021] [added: 2022] (incorporated herein by reference to Exhibit 10.3 to the Company's Current Report on Form 8-K filed on November [removed: 24, 2020,] [added: 23, 2021,] File No. [removed: 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572520000049/exhibit1032021freecash.htm)] [added: 001-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572521000056/exhibit103bostonscientific.htm)] | | |
| [removed: 10.65*] [added: 10.62] | | | | | | [Form of 2021 Global Non-Qualified Stock Option Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1065-2021grantxnqagreeme.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.65 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1065-2021grantxnqagreeme.htm)] | | |
| [removed: 10.66*] [added: 10.63] | | | | | | [Form of 2021 Global Restricted Stock Unit Award Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1066-2021grantxrsuagreem.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.66 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1066-2021grantxrsuagreem.htm)] | | |
| [removed: 10.67*] [added: 10.64] | | | | | | [Form of 2021 Performance Share Unit Award Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive Plan (Total Shareholder [removed: Return). #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1067-2021grantxtsragreem.htm)] [added: Return) (incorporated herein by reference to Exhibit 10.67 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1067-2021grantxtsragreem.htm)] | | |
| [removed: 10.68*] [added: 10.65] | | | | | | [Form of 2021 Performance Share Unit Award Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive Plan (Free Cash [removed: Flow). #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1068-2021grantxfcfagreem.htm)] [added: Flow) (incorporated herein by reference to Exhibit 10.68 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1068-2021grantxfcfagreem.htm)] | | |
| [removed: 10.69*] [added: 10.66] | | | | | | [Form of 2021 Restricted Stock Award Agreement for Non-Employee Directors under the Company’s Amended and Restated 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1069-2021grantxrsabodawa.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.69 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1069-2021grantxrsabodawa.htm)] | | |
| [removed: 10.70*] [added: 10.67] | | | | | | [Form of 2021 Restricted Stock Unit Award Agreement for Non-Employee Directors under the Company’s Amended and Restated 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1070-2021grantxrsubodawa.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.70 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1070-2021grantxrsubodawa.htm)] | | |
| [removed: 10.71] [added: 10.68] | | | | | | [Credit Agreement, dated as of May 10, 2021, by and among Boston Scientific Corporation, the several lenders parties thereto, Barclays Bank PLC, Citibank, N.A., Deutsche Bank Securities Inc., Goldman Sachs Bank USA, and JPMorgan Chase Bank, N.A as documentation agents, and Wells Fargo Bank, National Association, as administrative agent (incorporated herein by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on May 13, 2021, File No. 1-11083)](http://www.sec.gov/Archives/edgar/data/0000885725/000110465921065917/tm2116033d1_ex10-1.htm) | | |
| [removed: 10.72*] [added: 10.69] | | | | | | [Amendment, dated as of December 21, 2022, to Credit Agreement, dated as of May 10, 2021, by and among Boston Scientific Corporation, the several lenders parties thereto, Barclays Bank PLC, Citibank, N.A., Deutsche Bank Securities Inc., Goldman Sachs Bank USA, and JPMorgan Chase Bank, N.A as documentation agents, and Wells Fargo Bank, National Association, as administrative [removed: agent.](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1072-amendmentto2021revo.htm)] [added: agent (incorporated herein by reference to Exhibit 10.72 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1072-amendmentto2021revo.htm)] | | |
| [removed: 10.73] [added: 10.85] | | | | | | [Boston Scientific Corporation [removed: 2022] [added: 2023] Annual Bonus Plan, Performance Period January 1 [removed: -] [added: to] December 31, [removed: 2022 effective as of January 1, 2022] [added: 2023] (incorporated herein by reference to Exhibit 10.1 to the [removed: Company's] [added: Company’s] Current Report on Form 8-K filed on November [removed: 23, 2021,] [added: 21, 2022,] File No. [removed: 001-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572521000056/exhibit101bostonscientific.htm)] [added: 1-11083). #](https://www.sec.gov/Archives/edgar/data/885725/000088572522000030/exhibit101bostonscientific.htm)] | | |
| [removed: 10.74] [added: 10.72] | | | | | | [Boston Scientific Corporation 2022 Total Shareholder Return Performance Share Program, Performance Period January 1, 2022 - December 31, 2024 (incorporated herein by reference to Exhibit 10.2 to the Company's Current Report on Form 8-K filed on November 23, 2021, File No. 001-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572521000056/exhibit102bostonscientific.htm) | | |
| [removed: 10.75] [added: 10.87] | | | | | | [Boston Scientific Corporation [removed: 2022 Free Cash Flow] [added: 2023 Organic Net Sales Growth] Performance Share Program, Performance Period January 1 [removed: -] [added: –] December 31, [removed: 2022] [added: 2023,] (incorporated herein by reference to Exhibit 10.3 to the [removed: Company's] [added: Company’s] Current Report on Form 8-K filed on November [removed: 23, 2021,] [added: 21, 2022,] File No. [removed: 001-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572521000056/exhibit103bostonscientific.htm)] [added: 1-11083)). #](https://www.sec.gov/Archives/edgar/data/885725/000088572522000030/exhibit103bostonscientific.htm)] | | |
| [removed: 10.76*] [added: 10.74] | | | | | | [Form of 2022 Global Non-Qualified Stock Option Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1076-2022grantxnqagreeme.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.76 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, filed on February 23, 2023, File No. 1-110183). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1076-2022grantxnqagreeme.htm)] | | |
| [removed: 10.77*] [added: 10.75] | | | | | | [Form of 2022 Global Restricted Stock Unit Award Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1077-2022grantxrsuagreem.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.77 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, filed on February 23, 2023, File No. 1-110183). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1077-2022grantxrsuagreem.htm)] | | |
| [removed: 10.78*] [added: 10.76] | | | | | | [Form of 2022 Performance Share Unit Award Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive Plan (Total Shareholder [removed: Return). #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1078-2022grantxtsragreem.htm)] [added: Return) (incorporated herein by reference to Exhibit 10.78 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, filed on February 23, 2023, File No. 1-110183). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1078-2022grantxtsragreem.htm)] | | |
| [removed: 10.79*] [added: 10.77] | | | | | | [Form of 2022 Performance Share Unit Award Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive Plan (Free Cash [removed: Flow). #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1079-2022grantxfcfagreem.htm)] [added: Flow) (incorporated herein by reference to Exhibit 10.79 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, filed on February 23, 2023, File No. 1-110183). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1079-2022grantxfcfagreem.htm)] | | |
| [removed: 10.80*] [added: 10.78] | | | | | | [Form of 2022 Restricted Stock Award Agreement for Non-Employee Directors under the Company’s Amended and Restated 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1080-2022grantxrsabodawa.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.80 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, filed on February 23, 2023, File No. 1-110183). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1080-2022grantxrsabodawa.htm)] | | |
| [removed: 10.81*] [added: 10.79] | | | | | | [Form of 2022 Restricted Stock Unit Award Agreement for Non-Employee Directors under the Company’s Amended and Restated 2011 Long-Term Incentive [removed: Plan. #](https://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1081-2022grantxrsubodawa.htm)] [added: Plan (incorporated herein by reference to Exhibit 10.81 to the Company's Annual Report on Form 10-K for the year ended December 31, 2022, filed on February 23, 2023, File No. 1-110183). #](http://www.sec.gov/Archives/edgar/data/885725/000088572523000008/ex1081-2022grantxrsubodawa.htm)] | | |
| [removed: 10.82] [added: 10.80] | | | | | | [Form of EC Non-CEO Change in Control Agreement (incorporated herein by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed on May 6, 2022, File No. 1-11083). #](http://www.sec.gov/Archives/edgar/data/885725/000110465922057017/tm2214421d1_ex10-1.htm) | | |
| 3.4 | | | | | | [Certificate of Elimination relating to the 5.50% Mandatory Preferred Stock, Series A of the Company (incorporated herein by reference to Exhibit 3.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 filed on August 3, 2023, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000088572523000043/exhibit31-certificateofeli.htm) | | |
| 10.30* | | | | | | [Boston Scientific Corporation Executive Retirement Plan, as amended and restated effective June 1, 2022. #](https://www.sec.gov/Archives/edgar/data/885725/000088572524000017/exhibit1030-amendandrestat.htm) | | |
| 10.70 | | | | | | [Second Amendment, dated as of March 1, 2023, to Credit Agreement, dated as of May 10, 2021, by and among the Company, the several lenders parties thereto and Wells Fargo Bank, National Association, as administrative agent (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 1, 2023, File No. 1-011083.](http://www.sec.gov/Archives/edgar/data/885725/000088572523000010/exhibit101.htm) | | |
| 10.89 | | | | | | [Boston Scientific Corporation 2024 Relative Total Shareholder Return Performance Share Program, Performance Period January 1, 2024 – December 31, 2026 (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on November 22, 2023, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572523000051/exhibit102bostonscientific.htm) | | |
| 10.91 | | | | | | [Form of 2023 Global Non-Qualified Stock Option Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive Plan (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed on May 4, 2023, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572523000026/ex102-2023grantxnqagreemen.htm) | | |
| 10.92 | | | | | | [Form of 2023 Global Restricted Stock Unit Award Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive Plan (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed on May 4, 2023, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572523000026/ex103-2023grantxrsuagreeme.htm) | | |
| 10.93 | | | | | | [Form of 2023 Performance Share Unit Award Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive Plan (Total Shareholder Return) (incorporated herein by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed on May 4, 2023, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572523000026/ex104-2023grantxtsrawardag.htm) | | |
| 10.94 | | | | | | [Form of 2023 Performance Share Unit Award Agreement under the Company’s Amended and Restated 2011 Long-Term Incentive Plan (Free Cash Flow) (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report Form 10-Q for the quarter ended March 31, 2023, filed on May 4, 2023, File No. 1-11083).#](http://www.sec.gov/Archives/edgar/data/885725/000088572523000026/ex105-2023grantxonsgawarda.htm) | | |
| | | | | | | | | |
| 97* | | | | | | [Boston Scientific Corporation Dodd-Frank Clawback Policy](https://www.sec.gov/Archives/edgar/data/885725/000088572524000017/exhibit97-bscdoddxfrankcla.htm) | | |
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| 10.62 | | | | | | [Underwriting Agreement relating to the Mandatory Convertible Preferred Stock, dated as of May 21, 2020, among Boston Scientific Corporation and J.P. Morgan Securities LLC and BofA Securities Inc., as representatives of the underwriters. (incorporated herein by reference to Exhibit 1.2 to the Company's Current Report on Form 8-K filed on May 28, 2020, File No. 1-11083).](http://www.sec.gov/Archives/edgar/data/885725/000094787120000519/ss174270_ex0102.htm) | | |
An excerpt. Shown here: 40 of 53 rewritten, all 18 added and all 1 removed. The counts are complete. For every sentence, read Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES in the FY2023 filing and the FY2022 filing.
Item 16. FORM 10-K SUMMARY
17 rewritten, 12 added, 3 removed, 117 unchanged
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | Boston Scientific Corporation | | | | | | | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ Daniel J. Brennan | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ Michael F. Mahoney | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ Jonathan R. Monson | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ Nelda J. Connors | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ Charles J. Dockendorff | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ Yoshiaki Fujimori | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ Edward J. Ludwig | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ David J. Roux | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ John E. Sununu | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ David S. Wichmann | | |
| Dated: February [removed: 23, 2023] [added: 20, 2024] | | | | | | By: | | | | | | /s/ Ellen M. Zane | | |
| Description *(in millions)* | | | Balance at Beginning of Year | | | | | | [removed: Cumulative effect adjustment for adoption of ASU 2016-13(1)] | | | | | | Credit loss exposure(1) | | | | | | Write-offs(2) | | | | | | | | | | | | Balance at End of Year | | |
| Allowances for credit losses | | | $ | 108 | | | | | [removed: n/a] | | | | | | 35 | | | | | | (35) | | | | | | | | | | | | $ | 109 | |
| Allowances for credit losses | | | $ | 105 | | | | | [removed: n/a] | | | | | | 28 | | | | | | (25) | | | | | | | | | | | | $ | 108 | |
| Year Ended December 31, [removed: 2020:] [added: 2023:] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(1) [removed: Following the adoption of FASB ASC Topic 326 as of January 1, 2020, we] [added: We] record credit loss reserves to *Allowance for credit losses* when we establish [removed: *Trade] [added: Trade] accounts [removed: receivable*] [added: receivable] if credit losses are expected over the asset's contractual life.
| Dated: February 20, 2024 | | | | | | By: | | | | | | /s/ Jessica L. Mega | | |
| | | | | | | | | | | | | Jessica L. Mega | | |
| Dated: February 20, 2024 | | | | | | By: | | | | | | /s/ Susan E. Morano | | |
| | | | | | | | | | | | | Susan E. Morano | | |
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| Allowances for credit losses | | | $ | 109 | | | | | | | | | | | 50 | | | | | | (48) | | | | | | | | | | | | $ | 110 | |
| Dated: February 23, 2023 | | | | | | By: | | | | | | /s/ Donna A. James | | |
| | | | | | | | | | | | | Donna A. James | | |
| Allowances for uncollectible accounts | | | $ | 74 | | | | | 10 | | | | | | 49 | | | | | | (27) | | | | | | | | | | | | $ | 105 | |