Sentences and paragraphs of BSX's Risk Factors and MD&A, 10-K 2026-02-17 against 10-K 2025-02-18.
Each links to the text at sec.gov.
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RemovedRisk Factors
President Trump has indicated his willingness to increase the use of tariffs by the U.S. to accomplish certain U.S. policy goals. On February 1, 2025, President Trump signed three executive orders announcing his intent to impose 25% tariffs on imports from Canada and Mexico and a 10% additional tariff on imports from China. While the implementation of tariffs on imports from Mexico and Canada were paused, the Chinese tariffs took effect as scheduled and China responded by implementing 15% tariffs on certain U.S. imports. The implementation of new tariffs on imports from Canada, Mexico, China or other countries for an extended period and without specific exemptions for our products, and any reciprocal tariffs or other reactions by other countries thereto, could have a material adverse impact on our financial condition, results of operations and cash flows.
Read it in 10-K 2025-02-18 at sec.gov ↗
RewordedRisk Factors
In 2023, updates to the legislative text of the EU MDR were adopted by the European Parliament and the Council of the European Union, including an extension of Commission extended the transitional period to 2027 for certain high risk class devices and 2028 for lower risk class medical devices that have a valid CE Certificate to the Directives issued before May 2021. devices.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
While we continue to monitor legislative adoption of However, Pillar Two by country, remains enacted law and significant uncertainty exists regarding the implementation of the January 5th guidance as well as for additional guidance from the OECD, there is significant uncertainty that exists regarding the interpretation of the detailed existing Pillar Two rules, whether such rules will be implemented consistently across taxing jurisdictions, how such rules interact with existing national tax laws and whether such rules are consistent with existing tax treaty obligations.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
In the EU, we are required to comply with the Medical Device Regulation (MDR) (MDR), which became effective in May 2021, which superseded 2021 and changed multiple aspects of the Medical Device Directives. regulatory framework for CE Marking, including increased compliance requirements for the medical device industry.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
Lastly, geopolitical Geopolitical developments related to various ongoing global conflicts and tensions are sources of uncertainty and risk, and may cause disruptions to global or regional markets, supply chains or operations in applicable regions, including those related to the regions. Russia/Ukraine war, tension in the Taiwan strait, and conflicts in the Middle East.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
Medical devices that have a valid CE Certificate to the Directives issued before May 2021 could can continue to be sold during the applicable transition period or until the earlier of May 2024 or when the CE Certificate expired, expires, whichever comes first, provided there were are no significant changes to the design or intended use.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
From time to time, we announce certain initiatives, initiatives and/or goals, including goals, regarding our focus areas, which include related to sustainability and environmental matters, including carbon emissions and renewable energy goals, employee engagement, responsible sourcing, sourcing and social investments and diversity and inclusion. investments.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
There may be greater continues to exist significant uncertainty and market volatility following U.S. and global elections, including resulting from regarding potential shifts in trade policies, tariffs or and other trade protection measures, and the reaction of other countries thereto, or changes to international trade agreements, which could have a material adverse effect on our operations, including our ability to source and manufacture products in a timely and cost effective manner, financial condition, results of operations and/or liquidity.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
We may experience declines in market size, average selling prices for our products, medical procedure volumes and and/or our share of the markets in which we compete, which may materially adversely affect could have an adverse effect on our business, financial condition or results of operations and financial condition. operations.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
Any such matters, or related corporate social responsibility and responsibility, sustainability matters, or other similar matters could have a material adverse impact on our future business and results of operations, financial condition and cash flows. operations.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
The fact that we do not maintain third-party insurance coverage for all categories of losses increases our exposure to unanticipated claims and adverse decisions and these losses could have a material adverse effect on our financial condition, results of operations or liquidity.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
Continued consolidation in the health care industry or additional governmental controls exerted over pricing in and access in to key markets could lead to increased demands for price concessions or limit or eliminate our ability to sell to certain of our products, which could have an adverse effect on our business, financial condition or results of operations.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedRisk Factors
These and other environmental laws and regulations may have additional impacts on us or our suppliers, or result in liability to us. fines and penalties or litigation against us, which could adversely affect our financial condition.
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
(in millions, except per share data) Year Ended December 31, 2025 versus 2024 2025 versus 2024 2025 2024 $ % Reported net sales $ 20,074 $ 16,747 $ 3,327 19.9% Reported net income (loss) attributable to Boston Scientific common stockholders 2,898 1,853 1,045 56.4% Adjusted net income (loss) attributable to Boston Scientific common stockholders (non-GAAP measure) 4,574 3,725 849 22.8% Net income (loss) per common share — diluted 1.94 1.25 0.69 55.2% Adjusted net income (loss) per common share — diluted (non-GAAP measure) 3.06 2.51 0.55 21.9%
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
(in millions, except per share data) Year Ended December 31, 2024 versus 2023 2024 versus 2023 2024 2023 $ % Reported net sales $ 16,747 $ 14,240 $ 2,507 17.6% Reported net income (loss) attributable to Boston Scientific common stockholders 1,853 1,570 283 18.0% Adjusted net income (loss) attributable to Boston Scientific common stockholders (non-GAAP measure) 3,725 2,999 726 24.2% Net income (loss) per common share — diluted 1.25 1.07 0.18 16.8% Adjusted net income (loss) per common share — diluted (non-GAAP measure) 2.51 2.05 0.46 22.4%
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
The increases in our reported net sales and reported net income attributable to Boston Scientific common stockholders in 2025 and 2024 were primarily driven by innovation and strong commercial execution across our businesses, particularly in our Electrophysiology business unit, and which was led by the continued growth of our Farapulse™ Pulsed Field Ablation System which launched in the U.S. in early 2024. Refer to Results of Operations for a discussion of our net sales by business.
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
(1) Those acquisitions included the endoluminal vacuum therapy portfolio of Braun (Endoscopy), Silk Road Medical (Cardiovascular), Axonics (Urology) and Intera (Cardiovascular).
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
(2) Those acquisitions included our majority stake investment in Acotec (Cardiovascular), the acquisitions of Apollo (Endoscopy), Relievant (Neuromodulation), the endoluminal vacuum therapy portfolio of Braun (Endoscopy), Silk Road Medical (Cardiovascular) and Axonics (Urology).
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
Our Cardiovascular business develops and manufactures devices and medical technologies for diagnosing and treating a variety of diseases and abnormalities of the heart, as well as products to diagnose and treat peripheral arterial and venous diseases and various forms of cancer. In 2025 and 2024, reported net sales growth was primarily driven by the growth of our Electrophysiology business unit, led by our Farapulse™ Pulsed Field Ablation (PFA) System, continued market penetration of Left Atrial Appendage Closure (LAAC) procedures with our WATCHMAN™ LAAC Devices, as well as our coronary therapies franchise led by our AGENT™ Drug-Coated Balloon. As previously disclosed, in the second quarter of 2025, we announced the discontinuation of worldwide sales of the ACURATE Neo2™ and ACURATE Prime™ Aortic Valve Systems and that we would no longer pursue U.S. FDA approval for ACURATE or approval in other geographies. We will instead focus our resources and efforts on the remainder of the portfolio.
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
The impairment charges recorded in 2024 were primarily associated with amortizable intangible assets established in connection with our acquisitions of Cryterion Medical, Inc. (Cryterion) and Devoro Medical, Inc. (Devoro), which were
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
In addition, on May 28, 2025, we announced the discontinuation of worldwide sales of the ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems and that we would no longer pursue U.S. FDA approval for ACURATE or approval in other geographies. The decision resulted in total pre-tax restructuring and restructuring-related net charges of approximately $87 million in 2025. The activity was substantially complete at the end of 2025.
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was signed into law. It includes significant changes to corporate income taxes including extending and modifying many provisions of the Tax Cuts and Jobs Act. Provisions of the OBBBA impacting the Company include the immediate expensing of U.S. performed research and development expenditures as well as modifications to the taxation of our international operations. Certain provisions will take effect beginning in 2026, while others apply retroactively to January 1, 2025. The impact of OBBBA on our 2025 tax rate from continuing operations was immaterial, and we expect a similar impact in 2026.
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
Future legislative developments regarding the applicability of the Pillar Two tax on U.S. companies and additional guidance by the U.S. Department of the Treasury regarding OBBBA could impact our expectations and interpretations regarding the impact on our tax rate from continuing operations.
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
On January 27, 2026, we completed our acquisition of 100 percent of Nalu Medical, Inc. (Nalu Medical), a privately held medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic pain. We had been an investor in Nalu Medical since 2017 and previously held an equity stake of approximately 9 percent. The transaction to acquire the remaining stake consisted of an upfront cash payment of approximately $517 million, net of cash acquired. The Nalu Medical business will be integrated into our Neuromodulation division.
Read it in 10-K 2026-02-17 at sec.gov ↗
AddedMD&A
On January 15, 2026, we announced our entry into a definitive agreement to acquire 100 percent of Penumbra, Inc. (Penumbra), a publicly traded medical technology company primarily focused on thrombectomy products for use in peripheral vascular procedures in the removal of blood clots and blockages. The purchase price is valued at $374 per share, or approximately $14.500 billion. The transaction is expected to be completed in 2026, subject to customary closing conditions. We plan to fund the transaction consideration through a combination of cash on hand and newly issued debt in an aggregate amount equal to approximately $11.000 billion, and the remaining portion of the transaction consideration will be paid in shares of our common stock. The Penumbra business will be integrated into our Cardiovascular division.
Read it in 10-K 2026-02-17 at sec.gov ↗
RemovedMD&A
Our reported net income attributable to Boston Scientific common stockholders in 2024 was $1.853 billion, or $1.25 per diluted share. Our reported results for 2024 included certain charges and/or credits which are excluded by management for purposes of assessing operating performance, totaling $1.872 billion (after-tax), or $1.26 per diluted share. Excluding these items, adjusted net income attributable to Boston Scientific common stockholders3 for 2024 was $3.725 billion, or $2.51 per diluted share.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
Our reported net income attributable to Boston Scientific common stockholders in 2023 was $1.570 billion, or $1.07 per diluted share. Our reported results for 2023 included certain charges and/or credits which are excluded by management for purposes of assessing operating performance, totaling $1.429 billion (after-tax), or $0.98 per diluted share. Excluding these items, adjusted net income attributable to Boston Scientific common stockholders3 for 2023 was $2.999 billion, or $2.05 per diluted share.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
1Operational net sales growth excludes the impact of foreign currency fluctuations.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
Our Cardiology business develops and manufactures devices and medical technologies for diagnosing and treating a variety of diseases and abnormalities of the heart. Net sales of Cardiology products of $8.344 billion represented 50 percent of our consolidated net sales in 2024. Cardiology net sales increased $1.636 billion, or 24.4 percent in 2024 compared to 2023. This increase included operational net sales growth of 25.4 percent and the negative impact of 100 basis points from foreign currency fluctuations.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
Operational net sales growth was primarily driven by growth of our Electrophysiology business unit, led by our Farapulse™ Pulsed Field Ablation System and our access solutions portfolio, continued market penetration of Left Atrial Appendage Closure (LAAC) procedures with our WATCHMAN FLX™ LAAC Device and our WATCHMAN FLX™ Pro LAAC Device, as well as our percutaneous coronary intervention guidance franchise.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
Our Peripheral Interventions business develops and manufactures products to diagnose and treat peripheral arterial and venous diseases, as well as products to diagnose, treat and ease various forms of cancer. Net sales of Peripheral Interventions products of $2.410 billion represented 14 percent of our consolidated net sales in 2024. Peripheral Interventions net sales increased $300 million, or 14.2 percent in 2024 compared to 2023. This increase included operational net sales growth of 15.5 percent and the negative impact of 120 basis points from foreign currency fluctuations. Operational net sales growth included organic net sales growth of 10.9 percent, and the positive impact of 460 basis points from our majority stake investment in Acotec which we acquired in the first quarter of 2023 and our acquisition of Silk Road Medical during the third quarter of 2024.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
Organic net sales growth was primarily driven by our interventional oncology franchise led by our EMBOLD™ Fibered Coil and Therasphere™ Y-90 Radioactive Glass Microspheres, as well as our drug-eluting portfolio within our vascular franchise led by our Ranger™ Drug Coated Balloon.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
The following table provides our net sales by reportable segment and business, and the relative change in growth on a reported basis:
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
(1)In 2022, amounts reflect sales reserves established for Italian government payback provisions, not allocated to reportable segments, which are being disputed in the Italian court system.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
Refer to Executive Summary for further discussion of our net sales and a comparison of our 2024 and 2023 net sales.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
In 2023, we generated net sales of $14.240 billion compared to $12.682 billion in 2022. This increase of $1.558 billion, or 12.3 percent, included operational growth of 13.1 percent and the negative impact of 80 basis points from foreign currency fluctuations. Operational net sales growth included organic 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 and the acquisitions of Apollo and 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 were less than a full prior period of comparable net sales. The increase in our 2023 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.
Read it in 10-K 2025-02-18 at sec.gov ↗
RemovedMD&A
The following table provides a summary of our key operating expenses:Year Ended December 31, 2024 2023 2022 (in millions) $ % of Net Sales $ % of Net Sales $ % of Net Sales Selling, general and administrative expenses $ 5,984 35.7% $ 5,190 36.4% $ 4,520 35.6% Research and development expenses 1,615 9.6% 1,414 9.9% 1,323 10.4%
Read it in 10-K 2025-02-18 at sec.gov ↗
RewordedMD&A
Amortization expense 828 115 713 — 4 709 0.48 856 113 743 9 734 0.49 Goodwill and other intangible asset impairment charges 58 4 54 386 48 339 — — 54 0.04 339 0.23 Acquisition/divestiture-related net charges (credits) 373 21 352 403 28 375 — — 352 0.24 375 0.25 Restructuring and restructuring-related net charges (credits) 185 29 156 229 30 199 — — 156 0.11 199 0.13 Litigation-related net charges (credits) (111) (23) (88) — 0 (0) — (88) (0.06) (0) (0.00) Investment portfolio net losses (gains) and impairments 21 (3) 24 20 1 19 — — 24 0.02 19 0.01 EU MDR implementation costs 69 10 59 52 7 45 — — 59 0.04 45 0.03 Deferred tax expenses (benefits) — (155) 155 (165) 165 — — 155 165 0.11 Discrete tax items — (8) 8 4 (4) — — 8 0.01 (4) (0.00) Adjusted $ 3,407 4,229 $ 382 502 $ 3,025 3,726 $ (23) 1 $ 4 3,725 $ 2,999 $ 2.05 2.51
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
Amortization expense 856 113 743 — 897 127 770 9 734 0.49 761 0.51 Goodwill and other intangible asset impairment charges 386 48 339 46 8 37 — — 339 0.23 37 0.02 Acquisition/divestiture-related net charges (credits) 403 28 375 245 59 186 — — 375 0.25 186 0.12 Restructuring and restructuring-related net charges (credits) 229 30 199 343 46 298 — — 199 0.13 298 0.20 Litigation-related net charges (credits) 194 45 149 — 0 (0) — — (0) (0.00) 149 0.10 Investment portfolio net losses (gains) and impairments 20 1 19 26 (0) 26 — — 19 0.01 26 0.02 European Union (EU) Medical device regulation (MDR) implementation costs 52 7 45 46 6 39 — — 45 39 0.03 Deferred tax expenses (benefits) — (165) 165 (206) 206 — — 165 0.11 206 0.14 Discrete tax items — 4 (4) 27 (27) — — (4) (0.00) (27) (0.02) Adjusted $ 4,229 5,182 $ 502 605 $ 3,726 4,577 $ 3 $ 1 4,574 $ 3,725 $ 2.51 3.06
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
As indicated in the accompanying Management’s Annual Report on Internal Control over Financial Reporting, management’s assessment of Ltd., SoniVie Ltd., Intera Oncology®, Inc., Bolt Medical, Inc., and conclusion on the effectiveness of internal control over financial reporting did not include the internal controls of Silk Road Medical, Inc. and Axonics, Cortex, Inc., which are included in the 2024 2025 consolidated financial statements of the Company and constituted approximately less than one percent of total assets as of December 31, 2024 2025 and approximately less than one percent of revenues net sales for the year then ended.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
Gross Profit Margin Year Ended December 31, 2022 68.8% Manufacturing and supply costs 1.7% Sales pricing, volume and mix 1.9% Net impact of foreign currency fluctuations (2.2)% All other, including inventory charges and other period expenses (0.7)% Year Ended December 31, 2023 69.5% Sales pricing, volume and mix 0.7% All other, including inventory charges and other period expenses (1.6)% Year Ended December 31, 2024 68.6% Sales pricing, volume and mix 1.7% All other, including inventory charges and other period expenses (1.3)% Year Ended December 31, 2025 69.0%
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
Future events that could have a negative impact on the levels of excess fair value over carrying value of our reporting units include, but are not limited to, changes in economic and market conditions, a significant adverse change in legal factors, the following: level of success of ongoing and future research and development efforts, the level of success in managing the growth of acquired companies, operational performance of the business or key personnel, and an adverse action or assessment by a regulator.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
As indicated in the accompanying Management’s Annual Report on Internal Control over Financial Reporting, management’s assessment of and conclusion on the effectiveness of internal control over financial reporting did not include the internal controls of Silk Road Medical, Inc. and Axonics, Inc., which are included in the 2024 consolidated financial statements of the Company and constituted approximately one percent of total assets as of December 31, 2024 and approximately one percent of revenues for the year then ended. Anrei Medical (HZ) Co.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
The primary factors contributing to the increase in our that impacted gross profit margin for 2023 2025 compared to 2022 2024 were increased sales of higher margin products, as well as improvements in manufacturing, raw material and component, and freight costs, partially offset by inventory charges resulting from the unfavorable impact global discontinuation of foreign currency the ACURATE platform, increased levels of tariffs and other period expenses.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
Operational Organic net sales growth included organic2 excludes the impact of foreign currency fluctuations and net sales growth of 16.4 percent in 2024 and the positive impact of 210 basis points driven by our attributable to certain acquisitions and divestitures during the period for which there is are less than a full period of comparable net sales.
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RewordedMD&A
The increase in R&D expenses increased in both periods as a result of was driven by investments across our businesses in order businesses, including those required to support the development and clinical evidence necessary to bring newly acquired technologies to market and maintain a pipeline of new products that we believe will contribute to profitable sales growth.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
In 2024, 2025, cash provided by (used for) investing activities included net cash payments of $4.640 $1.593 billion for the acquisitions of multiple businesses, net of cash acquired, primarily related to the acquisitions of Axonics Bolt Medical, SoniVie Ltd., Cortex, Inc., Intera, and Silk Road Medical, Anrei Medical (HZ) Co., Ltd., and purchases of property, plant and equipment and internal use software of $790 $876 million.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
In 2024, 2025, cash provided by (used for) financing activities also included payments for finance leases of $258 million, proceeds from the issuances of common stock pursuant to employee stock compensation and purchase plans of $230 million $282 million, and net proceeds payments from the issuance of commercial paper of $187 million, partially offset by payments of contingent consideration previously established in purchase accounting of $131 $196 million.
Read it in 10-K 2026-02-17 at sec.gov ↗
RewordedMD&A
In 2023, 2025, cash provided by (used for) operating activities increased $977 million $1.100 billion as compared to 2022, 2024, primarily due to comparatively higher net sales and corresponding operating income, lower non-recurring tax payments compared to prior year, as well as timing of employee related accruals and prepaid expenses. income.
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Quiet changesMD&A
(1)Plans detailing specific employee impacts will be are developed for each affected region and business, working with employee representative bodies where required under local laws.
Read it in 10-K 2026-02-17 at sec.gov ↗
Quiet changesMD&A
To calculate organic net sales growth rates, we also remove the impact of certain acquisitions and divestitures with less than a full period of comparable net sales.
Read it in 10-K 2026-02-17 at sec.gov ↗