Boston Scientific Corporation

11/03/2025 | Press release | Distributed by Public on 11/03/2025 05:32

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Introduction
Boston Scientific Corporation is a global developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. Our mission is to transform lives through innovative medical solutions that improve the health of patients around the world. As a medical technology leader for more than 45 years, we have advanced the practice of less-invasive medicine by helping physicians and other medical professionals diagnose and treat a wide range of diseases and medical conditions and improve patients' quality of life by providing alternatives to surgery and other medical procedures that are typically traumatic to the body. We advance science for life by providing a broad range of high performance solutions to address unmet patient needs and reduce the cost of healthcare. When used in this report, the terms "we," "us," "our" and "the Company" mean Boston Scientific Corporation and its divisions and subsidiaries.
Financial Summary
Three Months Ended September 30, 2025
Our net sales for the third quarter of 2025 were $5.065 billion, compared to $4.209 billion for the third quarter of 2024. This increase of $855 million, or 20.3 percent, included operational1net sales growth of 19.4 percent and the positive impact of 90 basis points from foreign currency fluctuations. Operational net sales growth included organic2net sales growth of 15.3 percent and the positive impact of 420 basis points from certain acquisitions during the period for which there are less than a full period of comparable net sales. Those acquisitions included Silk Road Medical, Inc. (Silk Road Medical) and Axonics, Inc. (Axonics), during the third and fourth quarters of 2024, respectively, and Intera Oncology®, Inc. (Intera) during the second quarter of 2025. The increase in our net sales was primarily driven by strong commercial execution across our businesses, particularly in our Electrophysiology business unit, which was led by the continued growth of our Farapulse™ Pulsed Field Ablation System which launched in the U.S. in 2024 and in our Watchman business unit, which was led by the adoption of concomitant procedures in the U.S. Refer to Quarterly Results and Business Overviewfor a discussion of our net sales by business.
Our reported net income attributable to Boston Scientific common stockholders for the third quarter of 2025 was $755 million, or $0.51 per diluted share. Our reported results for the third quarter of 2025 included certain charges and/or credits totaling $369 million (after-tax), or $0.25 per diluted share. Excluding these items, adjusted net income attributable to Boston Scientific common stockholders3was $1.124 billion, or $0.75 per diluted share.
Our reported net income attributable to Boston Scientific common stockholders for the third quarter of 2024 was $469 million, or $0.32 per diluted share. Our reported results for the third quarter of 2024 included certain charges and/or credits totaling $469 million (after-tax), or $0.32 per diluted share. Excluding these items, adjusted net income attributable to Boston Scientific common stockholders3was $937 million, or $0.63 per diluted share.
1Operational net sales growth excludes the impact of foreign currency fluctuations.
2Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales.
3Adjusted measures, including operational and organic net sales growth and adjusted net income attributable to Boston Scientific common stockholders, exclude certain items required by generally accepted accounting principles in the United States (GAAP), are not prepared in accordance with GAAP and should not be considered in isolation from, or as a replacement for, the most directly comparable GAAP measure. Refer to Additional Informationfor a discussion of management's use of these non-GAAP financial measures.
The following is a reconciliation of our results of operations prepared in accordance with GAAP to those adjusted results considered by management. Refer to Quarterly Results and Business Overviewand Additional Informationfor a discussion of these reconciling items:
Three Months Ended September 30, 2025
(in millions, except per share data) Income (Loss) Before Income Taxes Income Tax Expense (Benefit) Net Income (Loss) Net Income (Loss) Attributable to Noncontrolling Interests Net Income (Loss) Attributable to Boston Scientific Common Stockholders Impact per Share
Reported $ 939 $ 183 $ 755 $ (0) $ 755 $ 0.51
Non-GAAP adjustments:
Amortization expense 225 31 194 2 191 0.13
Goodwill and other intangible asset impairment charges 0 0 0 - 0 0.00
Acquisition/divestiture-related net charges (credits) 99 4 95 - 95 0.06
Restructuring and restructuring-related net charges (credits) 36 6 30 - 30 0.02
Investment portfolio net losses (gains) and impairments (6) (1) (5) - (5) (0.00)
European Union (EU) Medical device regulation (MDR) implementation costs 11 2 9 - 9 0.01
Deferred tax expenses (benefits) - (47) 47 - 47 0.03
Discrete tax items - (1) 1 - 1 0.00
Adjusted $ 1,303 $ 177 $ 1,126 $ 2 $ 1,124 $ 0.75
Three Months Ended September 30, 2024
(in millions, except per share data) Income (Loss) Before Income Taxes Income Tax Expense (Benefit) Net Income (Loss) Net Income (Loss) Attributable to Noncontrolling Interests Net Income (Loss) Attributable to Boston Scientific Common Stockholders Impact per Share
Reported $ 669 $ 200 $ 468 $ (0) $ 469 $ 0.32
Non-GAAP adjustments:
Amortization expense 205 28 177 2 175 0.12
Acquisition/divestiture-related net charges (credits) 144 (56) 200 - 200 0.13
Restructuring and restructuring-related net charges (credits) 52 7 45 - 45 0.03
Investment portfolio net losses (gains) and impairments (1) 0 (1) - (1) (0.00)
EU MDR implementation costs 13 2 12 - 12 0.01
Deferred tax expenses (benefits) - (38) 38 - 38 0.03
Adjusted $ 1,082 $ 143 $ 939 $ 2 $ 937 $ 0.63
Nine Months Ended September 30, 2025
Our net sales for the first nine months of 2025 were $14.788 billion, compared to $12.186 billion for the first nine months of 2024. This increase of $2.602 billion, or 21.4 percent, included operational1net sales growth of 21.0 percent and the positive impact of 30 basis points from foreign currency fluctuations. Operational net sales growth included organic2net sales growth of 16.9 percent and the positive impact of 410 basis points from certain acquisitions during the period for which there are less than a full period of comparable net sales. Those acquisitions included the endoluminal vacuum therapy portfolio of B. Braun Medical Inc. (Braun), Silk Road Medical and Axonics during the first, third and fourth quarters of 2024, respectively, and Intera during the second quarter of 2025. The increase in our net sales was primarily driven by strong commercial execution across our businesses, particularly in our Electrophysiology business unit, which was led by the continued growth of our Farapulse™ Pulsed Field Ablation System which launched in the U.S. in early 2024 and in our Watchman business unit, which was led by the adoption of concomitant procedures in the U.S. Refer to Quarterly Results and Business Overviewfor a discussion of our net sales by business.
Our reported net income attributable to Boston Scientific common stockholders for the first nine months of 2025 was $2.226 billion, or $1.49 per diluted share. Our reported results for the first nine months of 2025 included certain charges and/or credits totaling $1.146 billion (after-tax), or $0.77 per diluted share. Excluding these items, adjusted net income attributable to Boston Scientific common stockholders3 for the first nine months of 2025 was $3.372 billion, or $2.26 per diluted share.
Our reported net income attributable to Boston Scientific common stockholders for the first nine months of 2024 was $1.288 billion, or $0.87 per diluted share. Our reported results for the first nine months of 2024 included certain charges and/or credits totaling $1.395 billion (after-tax), or $0.94 per diluted share. Excluding these items, adjusted net income attributable to Boston Scientific common stockholders3 for the first nine months of 2024 was $2.683 billion, or $1.81 per diluted share.
1Operational net sales growth excludes the impact of foreign currency fluctuations.
2Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales.
3Adjusted measures, including operational and organic net sales growth and adjusted net income attributable to Boston Scientific common stockholders, exclude certain items required by generally accepted accounting principles in the United States (GAAP), are not prepared in accordance with GAAP and should not be considered in isolation from, or as a replacement for, the most directly comparable GAAP measure. Refer to Additional Informationfor a discussion of management's use of these non-GAAP financial measures.
The following is a reconciliation of our results of operations prepared in accordance with GAAP to those adjusted results considered by management. Refer to Quarterly Results and Business Overviewand Additional Informationfor a discussion of these reconciling items:
Nine Months Ended September 30, 2025
(in millions, except per share data) Income (Loss) Before Income Taxes Income Tax Expense (Benefit) Net Income (Loss) Net Income (Loss) Attributable to Noncontrolling Interests Net Income (Loss) Attributable to Boston Scientific Common Stockholders Impact per Share
Reported $ 2,685 $ 463 $ 2,222 $ (4) $ 2,226 $ 1.49
Non-GAAP adjustments:
Amortization expense 669 93 576 7 570 0.38
Goodwill and other intangible asset impairment charges 46 8 37 - 37 0.02
Acquisition/divestiture-related net charges (credits) 156 (1) 157 - 157 0.10
Restructuring and restructuring-related net charges (credits) 247 32 215 - 215 0.14
Investment portfolio net losses (gains) and impairments (0) 0 (0) - (0) (0.00)
EU MDR implementation costs 34 5 29 - 29 0.02
Deferred tax expenses (benefits) - (139) 139 - 139 0.09
Discrete tax items - (1) 1 - 1 0.00
Adjusted $ 3,836 $ 461 $ 3,375 $ 3 $ 3,372 $ 2.26
Nine Months Ended September 30, 2024
(in millions, except per share data) Income (Loss) Before Income Taxes Income Tax Expense (Benefit) Net Income (Loss) Net Income (Loss) Attributable to Noncontrolling Interests Net Income (Loss) Attributable to Boston Scientific Common Stockholders Impact per Share
Reported $ 1,697 $ 413 $ 1,284 $ (4) $ 1,288 $ 0.87
Non-GAAP adjustments:
Amortization expense 631 86 545 7 539 0.36
Goodwill and other intangible asset impairment charges 276 33 243 - 243 0.16
Acquisition/divestiture-related net charges (credits) 256 (59) 315 - 315 0.21
Restructuring and restructuring-related net charges (credits) 149 20 129 - 129 0.09
Investment portfolio net losses (gains) and impairments 17 (0) 17 - 17 0.01
EU MDR implementation costs 39 5 34 - 34 0.02
Deferred tax expenses (benefits) - (120) 120 - 120 0.08
Adjusted $ 3,065 $ 380 $ 2,685 $ 2 $ 2,683 $ 1.81
Quarterly Results and Business Overview
The following section describes our net sales and results of operations by reportable segment and business. For additional information on our businesses and product offerings, refer to Item 1. Businessof our most recent Annual Report on Form 10-K.
Three Months Ended September 30,
(in millions) 2025 2024 Increase/(Decrease)
Endoscopy $ 747 $ 678 10.1%
Urology 682 532 28.1%
Neuromodulation 293 268 9.1%
MedSurg 1,722 1,479 16.4%
Cardiology 2,641 2,129 24.0%
Peripheral Interventions 702 602 16.7%
Cardiovascular 3,343 2,731 22.4%
Net Sales $ 5,065 $ 4,209 20.3%
Nine Months Ended September 30,
(in millions) 2025 2024 Increase/(Decrease)
Endoscopy $ 2,157 $ 1,996 8.0%
Urology 1,992 1,570 26.9%
Neuromodulation 866 807 7.4%
MedSurg 5,015 4,373 14.7%
Cardiology 7,717 6,048 27.6%
Peripheral Interventions 2,056 1,765 16.5%
Cardiovascular 9,773 7,813 25.1%
Net Sales $ 14,788 $ 12,186 21.4%
MedSurg
Endoscopy
Our Endoscopy business develops and manufactures devices to diagnose and treat a broad range of gastrointestinal (GI) conditions with innovative, less-invasive technologies. Net sales of Endoscopy products of $747 million during the third quarter and $2.157 billion during the first nine months of 2025 represented 15 percent of our consolidated net sales in both periods. Endoscopy net sales increased $69 million, or 10.1 percent, during the third quarter and $160 million, or 8.0 percent, during the first nine months of 2025, compared to the prior year periods. During the third quarter of 2025, this increase included operational net sales growth of 9.0 percent and the positive impact of 110 basis points from foreign currency fluctuations, compared to the prior year period. During the first nine months of 2025, this increase included operational net sales growth of 7.6 percent and the positive impact of 40 basis points from foreign currency fluctuations, compared to the prior year period.
Operational net sales growth during the third quarter of 2025 included organic net sales growth of 9.0 percent. Operational net sales growth during the first nine months of 2025 included organic net sales growth of 7.5 percent and the positive impact of 10 basis points from our acquisition of the endoluminal vacuum therapy portfolio of Braun during the first quarter of 2024. Organic net sales growth in both periods was primarily driven by our biliary franchise led by our AXIOS™ Stent and Delivery System, and our core GI and endoluminal surgery franchises.
Urology
Our Urology business develops and manufactures devices to treat various urological conditions for both male and female anatomies, including kidney stones, benign prostatic hyperplasia (BPH), prostate cancer, erectile dysfunction and incontinence. Net sales of Urology products of $682 million during the third quarter and $1.992 billion during the first nine months of 2025 represented 13 percent of our consolidated net sales in both periods. Urology net sales increased $150 million, or 28.1 percent, during the third quarter and $422 million, or 26.9 percent, during the first nine months of 2025, compared to the prior year periods. During the third quarter of 2025, this increase included operational net sales growth of 27.5 percent and the positive impact of 60 basis points from foreign currency fluctuations, compared to the prior year period. During the first nine months of 2025, this increase included operational net sales growth of 26.7 percent and a positive impact of 20 basis points from foreign currency fluctuations, compared to the prior year period.
Operational net sales growth included organic net sales growth of 5.4 percent during the third quarter and first nine months of 2025, and the positive impact of 2,210 and 2,130 basis points, respectively, from our acquisition of Axonics during the fourth quarter of 2024. Organic net sales growth in both periods was primarily driven by our stone management franchise.
Neuromodulation
Our Neuromodulation business develops and manufactures devices to treat various neurological movement disorders and manage chronic pain. Net sales of Neuromodulation products of $293 million during the third quarter and $866 million during the first nine months of 2025 represented 6 percent of our consolidated net sales in both periods. Neuromodulation net sales increased $24 million, or 9.1 percent, during the third quarter and $60 million, or 7.4 percent, during the first nine months of 2025, compared to the prior year periods. During the third quarter of 2025, this increase included operational net sales growth of 8.6 percent and the positive impact of 50 basis points from foreign currency fluctuations, compared to the prior year period. During the first nine months of 2025, this increase included operational net sales growth of 7.3 percent and a positive impact of 10 basis points from foreign currency fluctuations, compared to the prior year period.
Operational net sales growth in both periods was primarily driven by our Intracept™ Intraosseous Nerve Ablation System, and our spinal cord stimulation and deep brain stimulation franchises.
Cardiovascular
Cardiology
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 $2.641 billion during the third quarter and $7.717 billion for the first nine months of 2025 represented 52 percent of our consolidated net sales in both periods. Cardiology net sales increased $512 million, or 24.0 percent, during the third quarter and $1.669 billion, or 27.6 percent, during the first nine months of 2025, compared to the prior year periods. During the third quarter of 2025, this increase included operational net sales growth of 23.1 percent and the positive impact of 100 basis points from foreign currency fluctuations, compared to the prior year period. During the first nine months of 2025, this increase included operational net sales growth of 27.2 percent and a positive impact of 40 basis points from foreign currency fluctuations, compared to the prior year period.
Operational net sales growth in both periods was primarily driven by 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.
Peripheral Interventions
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 $702 million during the third quarter and $2.056 billion during the first nine months of 2025 represented 14 percent of our consolidated net sales in both periods. Peripheral Interventions net sales increased $101 million, or 16.7 percent, during the third quarter and $291 million, or 16.5 percent, during the first nine months of 2025, compared to the prior year periods. During the third quarter of 2025, this increase included operational net sales growth of 15.8 percent and the positive impact of 90 basis points from foreign currency fluctuations, compared to the prior year period. During the first nine months of 2025, this increase included operational net sales growth of 16.3 percent and a positive impact of 20 basis points from foreign currency fluctuations, compared to the prior year period.
Operational net sales growth included organic net sales growth of 6.3 percent during the third quarter of 2025 and 6.9 percent during the first nine months of 2025, and the positive impact of 950 and 940 basis points, respectively, from our acquisition of Silk Road Medical during the third quarter of 2024 and Intera during the second quarter of 2025. Organic net sales growth in both periods was primarily driven by our interventional oncology franchise led by our EMBOLD™ Fibered Coil, as well as our venous portfolio within our vascular franchise led by our Varithena™ Polidocanol Injectable Foam and EKOS™ Ultrasound Assisted Thrombolysis systems.
Emerging Markets
As part of our strategic imperative to drive global expansion, we are seeking to grow net sales and market share by expanding our global presence, including in Emerging Markets. Our Emerging Markets countries include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.
Our Emerging Markets' net sales represented 15 percent of our consolidated net sales during the third quarter and first nine months of 2025, respectively, and 16 percent and 17 percent during the third quarter and first nine months of 2024, respectively. During the third quarter of 2025, our Emerging Markets net sales grew 11.8 percent on a reported basis, which included operational net sales growth of 11.5 percent and a positive impact of 20 basis points from foreign currency fluctuations, compared to the prior year period. During the first nine months of 2025, our Emerging Markets net sales grew 10.0 percent on a reported basis, which included operational net sales growth of 11.2 percent and a negative impact of 110 basis points from foreign currency fluctuations, compared to the prior year period. Operational net sales growth in both periods was primarily driven by growth in China, fueled by the breadth of our portfolio and focus on innovation and strong commercial execution.
Economic Environment
As a global developer, manufacturer and marketer of medical devices, our business is subject to local and international macroeconomic trends as well as geopolitical factors. While global supply chain conditions have continued to improve, we have experienced, and may continue to experience, increases in cost and limited availability of 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. Uncertainty around inflationary pressures, interest rates, trade and tariff policies, foreign currency fluctuations and changes in tax laws, as well as actions by governments in response thereto, could create additional economic challenges which could negatively impact our business operations and results. We continue to anticipate incurring incremental costs under the current schedule of tariffs on U.S. imports announced by the U.S. government, as well as the subsequent increase in tariffs introduced by China on U.S. manufactured products. While some of the announced tariffs have been adjusted and the U.S. and other governments continue negotiations on such measures, these and any further tariff increases on our products by the U.S., China or any other country or region, as well as sanctions or other measures that restrict international trade, could have a material adverse impact on our business operations and results. We continue to monitor the evolving situation while exploring opportunities to mitigate the impacts of such tariffs. There can be no guarantee that we will be able to offset the impact of tariffs, the ultimate impact of which will depend on various factors, including the timing, scope, duration and nature of any tariffs, any other trade restrictions or opportunities to mitigate such impacts. In addition, geopolitical developments and uncertainties, including related to various ongoing global conflicts and tensions, may create economic, supply chain, transportation, energy, and other challenges, including disruptions to business operations, which could negatively impact our business and results of operations.
Gross Profit
Our Gross profitwas $3.542 billion and $10.175 billion for the third quarter and first nine months of 2025, respectively, and $2.897 billion and $8.395 billion for the third quarter and first nine months of 2024, respectively. The following is a reconciliation of our gross profit margin and a description of the drivers of the changes from period to period:
Percentage of Net Sales
Three Months Nine Months
Gross profit margin - period ended September 30, 2024 68.8% 68.9%
Sales pricing, volume and mix 1.8 1.8
All other, including inventory charges and other period expenses (0.7) (1.9)
Gross profit margin - period ended September 30, 2025 69.9% 68.8%
In the third quarter of 2025, the primary factors that impacted gross profit margin were increased sales of higher margin products, partially offset by increased levels of tariffs and other period expenses. In the first nine months of 2025, the primary factors that impacted gross profit margin were inventory charges of approximately $90 million resulting from the global discontinuation of the ACURATE platform, increased levels of tariffs and other period expenses, partially offset by increased sales of higher margin products.
Operating Expenses
The following table provides a summary of our key operating expenses:
Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
(in millions) $ % of Net Sales $ % of Net Sales $ % of Net Sales $ % of Net Sales
Selling, general and administrative expenses $ 1,741 34.4 % $ 1,562 37.1 % $ 5,053 34.2 % $ 4,372 35.9 %
Research and development expenses 514 10.1 % 407 9.7 % 1,483 10.0 % 1,156 9.5 %
Selling, General and Administrative (SG&A) Expenses
During the third quarter of 2025, SG&A expenses increased $179 million, or 11 percent, compared to the prior year period and were 270 basis points lower as a percentage of net sales. During the first nine months of 2025, SG&A expenses increased $681 million, or 16 percent compared to the prior year period and were 170 basis points lower as a percentage of net sales. The increase in SG&A expensesin the third quarter and first nine months of 2025 was driven by selling expenses associated with higher net sales and product launches, including the Farapulse™ Pulsed Field Ablation System in our Electrophysiology business unit.
Research and Development (R&D) Expenses
We remain committed to advancing medical technologies and investing in meaningful R&D projects across our businesses. During the third quarter of 2025, R&D expensesincreased $107 million, or 26 percent, compared to the prior year period and were 40 basis points higher as a percentage of net sales. During the first nine months of 2025, R&D expensesincreased $327 million, or 28 percent, compared to the prior year period and were 50 basis points higher as a percentage of net sales. The increase in R&D expensesin both periods was driven by investments across our businesses, including those required to support the development and clinical evidence necessary to bring newly acquired technologies to market and maintain a pipeline of products that we believe will contribute to profitable sales growth.
Other Operating Expenses
The following provides a summary of certain of our other operating expenses, which are excluded by management for purposes of evaluating operating performance; refer to Additional Informationfor a further description.
Amortization Expense
During the third quarter of 2025, Amortization expenseincreased $20 million, or 10 percent, compared to the prior year period. In the first nine months of 2025, Amortization expense increased $38 million, or 6 percent, compared to the prior year period.
Intangible Asset Impairment Charges
In 2025, we recorded Intangible asset impairment chargesof less than $1 million in the third quarter and $46 million in the first nine months. In 2024, we did not record anyIntangible asset impairment chargesin the third quarter and recorded Intangible asset impairment charges of $276 million in the first nine months. The impairment charges recorded in 2024 were associated with amortizable intangible assets established in connection with our acquisitions of Cryterion Medical, Inc. (Cryterion) and Devoro Medical, Inc. (Devoro), which were integrated into our Electrophysiology and Peripheral Interventions business units, respectively. Intangible assets acquired from Cryterion were impaired due to strong commercial adoption of our Farapulse™ Pulsed Field Ablation System and the resulting lower revenue projections and cannibalization of our cryoablation business in major markets like the U.S. Intangible assets acquired from Devoro were impaired following management's decision to cancel the related program in the second quarter of 2024.
Refer to Note C - Goodwill and Other Intangible Assetsto our unaudited consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q and Critical Accounting Policies and Estimatescontained in Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations of our most recent Annual Report on Form 10-K for additional details and a discussion of key assumptions used in our intangible asset impairment testing and future events that could have a negative impact on the recoverability of our intangible assets.
Contingent Consideration Net Expense (Benefit)
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions) 2025 2024 2025 2024
Net charges (benefit) $ 11 $ (23) $ 11 $ (4)
Payments for prior acquisitions following the achievement of associated milestones - 99 62 232
Refer to Note B - Acquisitions and Strategic Investmentsto our unaudited consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional details related to our contingent consideration arrangements.
Restructuring and Restructuring-related Net Charges (Credits)
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 helping to advance our Global Supply Chain Optimization strategy, which is intended to simplify our manufacturing and distribution network by transferring certain production lines among facilities and drive operational efficiencies and resiliency. Key activities under the 2023 Restructuring Plan also include optimizing certain functional capabilities to achieve cost synergies and better support business growth.
On July 29, 2025, our Board of Directors approved expanding the 2023 Restructuring Plan by up to $250 million in aggregate additional pre-tax charges, to include further related activities under the program to drive operational efficiencies and optimize functional capabilities. We continue to expect the activities associated with our 2023 Restructuring Plan, including the expansion, to be substantially complete by the end of 2025. The following table provides a summary of our range of estimates of total pre-tax charges associated with the 2023 Restructuring Plan, including the expansion, by major type of cost:
Type of Cost (in millions)
Total Estimated Amount Expected to be Incurred
Restructuring charges:
Termination benefits(1)
$ 100 - $ 120
Other(2)
60 - 80
Restructuring-related expenses:
Transfer costs(3)
320 - 350
Other(4)
220 - 250
$ 700 - $ 800
(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)Represents costs to transfer product and manufacturing lines between geographically dispersed facilities.
(4)Comprised of other costs directly related to the restructuring program, including program management, accelerated depreciation and fixed
asset write-offs.
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 $90 million in the first nine months of 2025. We expect the remaining activity to be substantially complete by the end of 2025.
Pursuant to the 2023 Restructuring Plan and the ACURATE discontinuation, we recorded the following restructuring and restructuring-related charges:
Three Months Ended September 30, Nine Months Ended
September 30,
(in millions) 2025 2024 2025 2024
Restructuring net charges (credits)(1)
$ (8) $ 8 $ 85 $ 12
Restructuring-related net charges (credits)(2)
45 44 161 136
(1)These charges are recorded in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 420, Exit or Disposal Cost Obligations.
(2)These charges are primarily recorded within Cost of products sold, SG&A Expenses and R&D Expenses.
The following table presents our restructuring reserve balance:
As of
(in millions) September 30, 2025 December 31, 2024
Restructuring reserve balance $ 69 $ 26
Litigation-related Net Charges (Credits)
We record certain legal and product liability charges, credits and costs of defense, which we consider to be unusual or infrequent and significant as Litigation-related net charges (credits)within our accompanying unaudited consolidated financial statements. We did not record any litigation-related net charges (credits) during the third quarter and first nine months of 2025 or 2024. All other legal and product liability charges, credits and costs are recorded within SG&A expenses.
We continue to assess certain litigation and claims to determine the amounts, if any, that management believes will be paid as a result of such claims and litigation, and therefore, additional losses may be accrued and paid in the future, which could materially adversely impact our operating results, cash flows and/or our ability to comply with the financial covenant required by our credit arrangements. Refer to Note H - Commitments and Contingenciesto our unaudited consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q for discussion of our material legal proceedings.
Interest Expense
The following table provides a summary of our Interest expenseand average borrowing rate:
Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Interest expense (in millions)
$ (87) $ (79) $ (259) $ (225)
Average borrowing rate 2.9 % 2.8 % 2.9 % 2.8 %
Interest expenseincreased during the third quarter and first nine months of 2025 compared to the prior year period primarily due to a higher average borrowing rate and higher average outstanding debt balances. Refer to Liquidity and Capital Resourcesand Note E - Contractual Obligations and Commitmentsto our unaudited consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q for more information regarding our debt obligations.
Tax Rate
The following table provides a reconciliation of our reported tax rate to the rate from continuing operations:
Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Reported tax rate 19.5 % 30.0 % 17.2 % 24.4 %
Impact of certain receipts/charges(1)
(1.4) % (12.3) % 0.9 % (6.0) %
Rate from continuing operations 18.1 % 17.7 % 18.1 % 18.3 %
(1)These receipts/charges are taxed at different rates than our rate from continuing operations.
Our reported tax rate is affected by recurring items such as the amount of our earnings subject to differing tax rates in foreign jurisdictions and the impact of certain receipts and charges that are taxed at rates that differ from our rate from continuing operations.
In the third quarter and first nine months of 2025, the principal reason for the difference between the rate from continuing operations and our reported tax rate relates to certain acquisition-related net charges and certain discrete tax benefits primarily related to stock-based compensation.
In the third quarter of 2024, the principal reason for the difference between the rate from continuing operations and our reported tax rate relates to certain acquisition-related net charges. In the first nine months of 2024, the principal reasons for the difference between the rate from continuing operations and our reported tax rate relate to certain acquisition-related net charges, impairment charges and certain discrete tax benefits primarily related to stock-based compensation.
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. Based on our current analysis of OBBBA, we expect an immaterial impact to our overall effective tax rate, financial condition, results of operations, and cash flow in 2025.
Effective January 1, 2024, many countries where we do business adopted a global minimum effective tax rate of 15% based on the Pillar Two framework issued by the Organization for Economic Cooperation and Development (OECD). The United States has not enacted the Pillar Two global minimum tax and as of June 28, 2025 the G7 countries announced an agreement to exempt U.S. companies from certain elements of the OECD global minimum tax framework. We expect that this agreement, if ultimately enacted into law in the relevant countries, would be beneficial to the Company. However, Pillar Two remains enacted law and significant uncertainty exists regarding the implementation of this agreement, the interpretation of the 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. Developments related to these uncertainties could impact our expectations regarding the impact of the Pillar Two global minimum tax on our tax rate from continuing operations in 2025 and beyond.
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.
See Note G - Income Taxesto our unaudited consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional details on our tax rate.
Critical Accounting Policies and Estimates
Our financial results are affected by the selection and application of accounting policies and methods. During the third quarter and first nine months of 2025, there were no material changes to the application of critical accounting policies previously disclosed in our most recent Annual Report on Form 10-K.
Liquidity and Capital Resources
Based on our current business plan, we believe our existing balance of Cash and cash equivalents, future cash generated from operations, access to capital markets and existing credit facilities will be sufficient to fund our operations, invest in our infrastructure, pay our legal-related liabilities, pay taxes due, service and repay our existing debt and fund possible acquisitions for the next 12 months and for the foreseeable future.
As of September 30, 2025, we had $1.275 billion of unrestricted Cash and cash equivalentson hand, including approximately $61 million held by Acotec Scientific Holdings Limited, a less than wholly owned entity of which we acquired a majority stake investment during the first quarter of 2023. The balance is comprised of $382 million invested in money market funds and time deposits and $893 million in interest bearing and non-interest-bearing bank accounts. We invest excess cash on hand in short-term financial instruments that earn at market interest rates while mitigating principal risk through instrument and counterparty diversification, as well as what we believe to be prudent instrument selection. We limit our direct exposure to securities in any one industry or issuer.
In 2021, we entered into our $2.750 billion revolving credit facility (as amended, supplemented or otherwise modified from time to time, the 2021 Revolving Credit Facility) with a global syndicate of commercial banks. The 2021 Revolving Credit Facility has a maturity date of May 10, 2029. This facility provides backing for our commercial paper program, and outstanding commercial paper directly reduces borrowing capacity under the 2021 Revolving Credit Facility. There were no amounts outstanding under our commercial paper program as of September 30, 2025. There were no amounts outstanding under the 2021 Revolving Credit Facility as of September 30, 2025, resulting in an additional $2.750 billion of available liquidity.
For additional details related to our debt obligations, including our financial covenant requirement, refer to Note E - Contractual Obligations and Commitmentsto our unaudited consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
The following provides a summary and description of our net cash inflows (outflows):
Nine Months Ended September 30,
(in millions) 2025 2024
Cash provided by (used for) operating activities $ 3,170 $ 1,979
Cash provided by (used for) investing activities (2,128) (1,983)
Cash provided by (used for) financing activities (211) 1,600
Operating Activities
During the first nine months of 2025, cash provided by (used for) operating activities increased $1.191 billion compared to the prior year period primarily due to comparatively higher sales and corresponding operating income and slower inventory buildup.
Investing Activities
During the first nine months of 2025, cash provided by (used for) investing activities included net cash payments of $1.504 billion for acquisitions of businesses, primarily related to Bolt Medical, Inc., SoniVie Ltd., Cortex, Inc., Intera, and Anrei Medical (HZ) Co., Ltd, and purchases of property, plant and equipment and internal use software of $525 million. During the first nine months of 2024, cash used for investing activities included net cash payments of $1.222 billion for acquisitions of businesses, primarily related to Silk Road Medical, purchases of property, plant and equipment and internal use softwareof $513 million as well as payments for investments and acquisitions of certain technologies, net of investment proceedsof $264 million. For more information on our acquisitions, refer to Note B - Acquisitions and Strategic Investmentsto our unaudited consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Financing Activities
During the first nine months of 2025, cash provided by (used for) financing activities included the registered public offering of €1.500 billion in aggregate principal amount of euro-denominated senior notes (the 2025 Eurobonds). The 2025 Eurobonds offering resulted in cash proceeds of $1.558 billion, net of investor discounts and issuance costs. We used the net proceeds from the 2025 Eurobonds offering to fund the repayment at maturity of AMS Europe's €1.000 billion 0.750% Senior Notes due March 2025 and to pay accrued and unpaid interest with respect to such notes. Additionally, we used the remaining net proceeds for general corporate purposes, including, among other things, short term investments, reduction of short term debt, funding of working capital and acquisitions. During the second quarter of 2025, we also repaid at maturity our $500 million 1.900%Senior Notes due June 2025 and accrued and unpaid interest with respect to such notes.During the first nine months of 2025, cash provided by (used for) financing activities also included proceeds from the issuances of common stock pursuant to employee stock compensation and purchase plans of $262 million, partially offset by repayments of commercial paper of $196 million. For more information, refer to Note E - Contractual Obligations and Commitmentsto our unaudited consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Cash provided by (used for) financing activities in the first nine months of 2024 included a registered public offering of €2.000 billion in aggregate principal amount of euro-denominated senior notes (the 2024 Eurobonds). The 2024 Eurobonds offering resulted in cash proceeds of $2.145 billion, net of investor discounts and issuance costs. We primarily used the net proceeds from the 2024 Eurobonds offering to fund a portion of the purchase price of our acquisition of Axonics and to pay related fees and expenses, and for general corporate purposes. We also used the net proceeds to fund the repayment at maturity of $504 million of our 3.450% Senior Notes due March 2024 and to pay accrued and unpaid interest with respect to such notes.
Financial Covenant
As of September 30, 2025, we were in compliance with the financial covenant required by the 2021 Revolving Credit Facility.
Covenant Requirement
as of September 30, 2025
Actual
as of September 30, 2025
Maximum permitted leverage ratio(1)
4.75 times 2.02 times
(1)Ratio of total debt to deemed consolidated EBITDA, as defined by the 2021 Revolving Credit Facility credit agreement.
The 2021 Revolving Credit Facility includes the financial covenant requirement for all of our credit arrangements that we maintain the maximum permitted leverage ratio of 3.75 times for the remaining term. The credit agreement provides for higher leverage ratios, at our election, for the period following a Qualified Acquisition, as defined by the agreement, for which consideration exceeds $1.000 billion. In the event of such an acquisition, for the four succeeding quarters immediately following, including the quarter in which the acquisition occurs, the maximum permitted leverage ratio is 4.75 times. It steps down for the fifth, sixth and seventh succeeding quarters to 4.50 times, 4.25 times and 4.00 times, respectively. Thereafter, a maximum leverage ratio of 3.75 times is required through the remaining term of the 2021 Revolving Credit Facility. On November 15, 2024, we announced the closing of our acquisition of Axonics, which we had previously designated as a Qualified Acquisition under the credit agreement, increasing the maximum permitted leverage ratio to 4.75 times as of September 30, 2025. We believe that we have the ability to comply with the financial covenant for the next 12 months.
The financial covenant requirement, as amended on May 10, 2024, provides for an exclusion from the calculation of consolidated EBITDA, through maturity, of certain charges and expenses. The credit agreement amendment reset the starting date for purposes of calculating such permitted exclusions related to restructuring charges and restructuring-related expenses from December 31, 2022 to March 31, 2024. Permitted exclusions include up to $500 million in cash and non-cash restructuring charges and restructuring-related expenses associated with our current or future restructuring plans. As of
September 30, 2025, we had $77 million of the restructuring charge exclusion remaining. In addition, any cash litigation payments (net of any cash litigation receipts), as defined by the agreement, are excluded from the calculation of consolidated EBITDA, provided that the sum of any excluded net cash litigation payments does not exceed $1.000 billion plus all accrued legal liabilities as of December 31, 2022. As of September 30, 2025, we had $1.406 billion of the litigation exclusion remaining.
Contractual Obligations and Commitments
On October 17, 2025, we announced our entry into a definitive agreement to acquire 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 have been an investor in Nalu Medical since 2017 and currently hold an equity stake of approximately nine percent. The transaction price to acquire the remaining stake is expected to result in an upfront cash payment of approximately $533 million upon closing. The transaction is expected to close during the first half of 2026, subject to customary closing conditions. We plan to fund the acquisition with cash on hand. The Nalu Medical business will be integrated into our Neuromodulation division.
Certain of our acquisitions involve the payment of contingent consideration. Refer to Note B - Acquisitions and Strategic Investments to our unaudited consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q for further details regarding the estimated potential amount of future contingent consideration we could be required to pay associated with our acquisitions. There have been no other material changes to our contractual obligations and commitments as of September 30, 2025.
Equity
We received $262 million during the first nine months of 2025 and $202 million during the first nine months of 2024 in proceeds from stock issuances related to our stock option and employee stock purchase plans. Proceeds from the exercise of employee stock options and employee stock purchases vary from period to period based upon, among other factors, fluctuations in the trading price of our common stock and in the exercise and stock purchase patterns of our employees.
We did not repurchase any shares of our common stock during the first nine months of 2025 or 2024. On December 14, 2020, our Board of Directors approved a new stock repurchase program authorizing the repurchase of up to $1.000 billion of our common stock. As of September 30, 2025, we had the full amount remaining available under the authorization.
Legal Matters
For a discussion of our material legal proceedings refer to Note H - Commitments and Contingenciesto our unaudited consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q and Note I - Commitments and Contingenciesto our audited financial statements contained in Item 8 of our most recent Annual Report on Form 10-K.
Recent Accounting Pronouncements
Information regarding new accounting pronouncements implemented since December 31, 2024, and relevant accounting pronouncements to be implemented in the future are included in Note M - New Accounting Pronouncementsto our unaudited consolidated financial statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Additional Information
Use of Non-GAAP Financial Measures
To supplement our unaudited consolidated financial statements presented on a GAAP basis, we disclose certain non-GAAP financial measures, including adjusted net income (loss), adjusted net income (loss) attributable to Boston Scientific common stockholders and adjusted net income (loss) per share (EPS) that exclude certain charges (credits); operational net sales, which exclude the impact of foreign currency fluctuations; and organic net sales, which exclude the impact of foreign currency fluctuations as well as the impact of certain acquisitions and divestitures with less than a full period of comparable net sales. These non-GAAP financial measures are not in accordance with U.S. GAAP and should not be considered in isolation from or as a replacement for the most directly comparable GAAP financial measures. Further, other companies may calculate these non-GAAP financial measures differently than we do, which may limit the usefulness of those measures for comparative purposes.
To calculate adjusted net income (loss), adjusted net income (loss) attributable to Boston Scientific common stockholders and adjusted net income (loss) per share, we exclude certain charges (credits) from GAAP net income and GAAP net income attributable to Boston Scientific common stockholders, which include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), EU MDR implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items. Amounts are presented after-tax using our effective tax rate, unless the amount is a significant unusual or infrequently occurring item in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 740-270-30, "General Methodology and Use of Estimated Annual Effective Tax Rate." In addition to the explanation below, please refer to Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission for an explanation of each of these adjustments and the reasons for excluding each item. The following is an explanation of each incremental or revised adjustment type, since our most recent Annual Report on Form 10-K, that management excluded as part of these non-GAAP financial measures as well as the reason for excluding each item:
Restructuring and restructuring-related net charges (credits) - These adjustments primarily represent severance and other compensation-related charges, fixed asset write-offs, contract cancellations, project management fees, facility shut down costs, costs to transfer manufacturing lines between geographically dispersed facilities and other direct costs associated with our restructuring plans. These restructuring plans each consist of distinct initiatives that are fundamentally different from our ongoing, core cost reduction initiatives in terms of, among other things, the frequency with which each action is performed and the required planning, resourcing, cost and timing. Examples of such initiatives include the movement of business activities, facility consolidations and closures and the transfer of product lines between manufacturing facilities, which, due to the highly regulated nature of our industry, requires a significant investment in time and cost to create duplicate manufacturing lines, run product validations and seek regulatory approvals. Restructuring plans take place over a defined timeframe and have a distinct project timeline that requires, and begins subsequent to, approval by our Board of Directors. In contrast to our ongoing cost reduction initiatives, restructuring plans typically result in duplicative cost and exit costs over the defined timeframe and are not considered part of our core, ongoing operations. In addition, during the second and third quarter of 2025, we incurred restructuring and restructuring-related net charges (credits) associated with management's decision to discontinue worldwide sales of the ACURATE neo2TMand ACURATE PrimeTMAortic Valve Systems. These restructuring plans and activities are incremental to the core activities that arise in the ordinary course of our business. Restructuring and restructuring-related net charges (credits) are excluded from management's assessment of operating performance and from our operating segments' measures of profit and loss used for making operating decisions and assessing performance.
The GAAP financial measures most directly comparable to adjusted net income (loss), adjusted net income (loss) attributable to Boston Scientific common stockholders and adjusted net income (loss) per share are GAAP net income (loss), GAAP net income (loss) attributable to Boston Scientific common stockholders and GAAP net income (loss) per common share - diluted, respectively.
To calculate operational net sales growth rates, which exclude the impact of foreign currency fluctuations, we convert actual net sales from local currency to U.S. dollars using constant foreign currency exchange rates in the current and prior periods. 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. The GAAP financial measure most directly comparable to operational net sales and organic net sales is net sales reported on a GAAP basis.
Reconciliations of each of these non-GAAP financial measures to the corresponding GAAP financial measure are included in the relevant sections of this Quarterly Report on Form 10-Q.
Management uses these supplemental non-GAAP financial measures to evaluate performance period over period, to analyze the underlying trends in our business, to assess our performance relative to our competitors and to establish operational goals and forecasts that are used in allocating resources. In addition, management uses these non-GAAP financial measures to further its understanding of the performance of our operating segments. The adjustments excluded from our non-GAAP financial measures are consistent with those excluded from our operating segments' measures of net sales and profit or loss. These adjustments are excluded from the segment measures reported to our chief operating decision maker that are used to make operating decisions and assess performance.
We believe that presenting adjusted net income (loss), adjusted net income (loss) attributable to Boston Scientific common stockholders, adjusted net income (loss) per share, operational net sales growth rates and organic net sales growth rates, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for its operational decision-making and allows investors to see our results "through the eyes" of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.
Safe Harbor for Forward-Looking Statements
Certain statements that we may make from time to time, including statements contained in this Quarterly Report on Form 10-Q and information incorporated by reference herein, constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend," "aim," "goal," "target," "continue," "hope," "may" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.
The forward-looking statements in this Quarterly Report on Form 10-Q are based on certain risks and uncertainties, including the risk factors described in Part I, Item 1A. Risk Factorsin our most recent Annual Report on Form 10-K and the specific risk factors discussed herein and in connection with forward-looking statements throughout this Quarterly Report on Form 10-Q, which could cause actual results to vary materially from the expectations and projections expressed or implied by our forward-looking statements. These risks and uncertainties, in some cases, have affected and in the future could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this Quarterly Report on Form 10-Q. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Risks and uncertainties that may cause such differences include, among other things: economic conditions, including the impact of foreign currency fluctuations; future U.S. and global political, competitive, reimbursement and regulatory conditions, including changing trade and tariff policies; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions and the market acceptance of those products; market competition for our products; expected pricing environment; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property rights; litigation; financial market conditions; the execution and effect of our restructuring program; the execution and effect of our business strategy, including our cost-savings and growth initiatives; our ability to achieve environmental, social and governance goals and commitments; and future business decisions made by us and our competitors. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, refer to Part I, Item 1A. Risk Factorsin our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A. Risk Factorsin subsequent Quarterly Reports on Form 10-Q that we will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this Quarterly Report on Form 10-Q.
The following are some of the important risk factors that could cause our actual results to differ materially from our expectations in any forward-looking statements. For further discussion of these and other risk factors, refer to Part I, Item 1A. Risk Factorsin our most recent Annual Report on Form 10-K.
Our Business
Risks associated with uncertain domestic or international economic conditions, including those related to inflationary pressures, interest rates, monetary and tax policy, changing trade and tariff policies, sustained disruption of government operations, supply chain disruptions and constraints, currency devaluations or economies entering into periods of recession,
The impact of disruptions in the supply of the materials and components used in manufacturing our products or the sterilization of our products,
Labor shortages and the impact of inflation on the cost of raw materials and wage costs,
Impacts from changing U.S. trade policies and newly introduced tariffs, and any countermeasures or other reactions by other countries thereto,
The impact of pandemics or other public health crises on worldwide economies, financial markets, manufacturing and distribution systems and business operations,
The impact of natural disasters, climate change or other catastrophic events on our ability to manufacture, distribute and sell our products,
The impact of competitive offerings, value-based procurement practices, government-imposed payback provisions and changes in reimbursement practices and policies on average selling prices for our products,
The ongoing impact on our business of physician alignment to hospitals, governmental investigations and audits of hospitals and other market and economic conditions on the overall number of procedures performed,
The performance of, and physician and patient confidence in, our products and technologies or those of our competitors,
The impact and outcome of ongoing and future clinical trials and market studies undertaken by us, our competitors or other third parties or perceived product performance of our or our competitors' products,
Variations in clinical results, reliability or product performance of our and our competitors' products,
Our ability to acquire or develop, launch and supply new or next-generation products and technologies worldwide and in line with our commercialization strategies in a timely and successful manner and with respect to our recent acquisitions,
The effect of consolidation and competition in the markets in which we do business or plan to do business,
Our ability to achieve our projected level or mix of product sales, as some of our products are more profitable than others,
Our ability to attract and retain talent, including key personnel associated with acquisitions, and to maintain our corporate culture in a hybrid work environment,
Risks associated with changes made or expected to be made to our organizational and operational structure, pursuant to our restructuring plans as well as any further restructuring or optimization plans we may undertake in the future, including operational interruptions as we continue to implement our new global enterprise resource planning (ERP) system, or any divestitures of assets or businesses, and our ability to recognize benefits and cost reductions from such actions,
The impact of enhanced requirements to obtain and maintain regulatory approval in the U.S. and around the world, including EU MDR and the associated timing and cost of product approval,
The impact of increased pressure on the availability and rate of third-party reimbursement for our products and procedures in the U.S. and around the world, including with respect to the timing and costs of creating and expanding markets for new products and technologies,
The issuance of new or revised accounting standards by the Financial Accounting Standards Board or the Securities and Exchange Commission, and
The impact of potential goodwill and intangible asset impairment charges on our results of operations.
Regulatory Compliance, Litigation and Data Protection
The impact of healthcare policy changes and legislative or regulatory efforts in the U.S., the EU and around the world to modify product approval or reimbursement processes, including a trend toward demonstrating clinical outcomes, comparative effectiveness and cost efficiency, as well as the impact of other healthcare reform legislation,
Risks associated with our regulatory compliance and quality systems and activities in the U.S., the EU and around the world, including meeting regulatory standards applicable to manufacturing and quality processes,
Our ability to minimize or avoid future field actions or FDA warning letters, or similar actions by regulatory agencies around the world, relating to our products and processes and the ongoing inherent risk of potential physician advisories related to our or our competitors' products,
The impact of increased scrutiny of and heightened global regulatory enforcement facing the medical device industry arising from political and regulatory changes, economic pressures or otherwise, including under U.S. Anti-Kickback Statute, U.S. False Claims Act and similar laws in other jurisdictions, U.S. Foreign Corrupt Practices Act (FCPA) and similar laws in other jurisdictions, and U.S. and foreign export control, trade embargo and customs laws,
The effect of global legal, regulatory or market responses to climate change and sustainability matters, including increased compliance burdens and costs to meet regulatory obligations,
Costs and risks associated with current and future asserted litigation,
The effect of our litigation and risk management practices, including self-insurance and compliance activities on our loss contingencies, legal provisions and cash flows,
The impact of, diversion of management attention as a result of, and costs to cooperate with, litigate and/or resolve governmental investigations and our class action, product liability, contract and other legal proceedings,
The possibility of failure to protect our intellectual property rights and the outcome of patent litigation, and
Our ability to secure our information technology and operational technology systems that support our business operations and protect our data integrity and products from a cyber-attack, other breach or other malicious actors that may have a material adverse effect on our business, reputation or results of operations, including increased risks as an indirect result of the ongoing Russia/Ukraine war and conflicts in the Middle East.
Innovation and Certain Growth Initiatives
The timing, size and nature of our strategic growth initiatives and market opportunities, including with respect to our internal research and development platforms and externally available research and development platforms and technologies and the ultimate cost and success of those initiatives and opportunities,
Our ability to complete planned clinical trials successfully, obtain regulatory approvals and launch new and next generation products in a timely manner consistent with cost estimates, including the successful completion of projects from in-process research and development,
Our ability to identify and prioritize our internal research and development project portfolio and our external investment portfolio on profitable net sales growth opportunities as well as to maintain the estimated timing and costs of such projects and expected revenue levels for the resulting products and technologies,
Our ability to develop, manufacture and market new products and technologies successfully and in a timely manner and the ability of our competitors and other third parties to develop products or technologies that render our products or technologies noncompetitive or obsolete,
Our ability to execute appropriate decisions to discontinue, write-down or reduce the funding of any of our research and development projects, including projects from in-process research and development from our acquisitions, in our growth adjacencies or otherwise,
Our dependence on acquisitions, alliances or investments to introduce new products or technologies and to enter new or adjacent growth markets and our ability to fund them or to fund contingent payments with respect to those acquisitions, alliances and investments, and
The potential failure to successfully integrate, collaborate or realize the expected benefits, including cost synergies, from strategic acquisitions, alliances and investments we have consummated or may consummate in the future.
International Markets
Our dependency on international net sales to achieve growth, and our ability to maintain or expand our worldwide market positions in the various markets in which we compete or seek to compete, including through investments in China and other Emerging Markets countries,
The timing and collectability of customer payments, as well as our ability to continue factoring customer receivables where we have factoring arrangements, or to enter new factoring arrangements with favorable terms,
The impact on pricing due to national and regional tenders, including value-based procurement practices and government-imposed payback provisions,
Geopolitical and economic conditions, including civil unrest, terrorist activity, governmental changes, restrictions on the ability to transfer capital across borders, and changing tariff and trade policies,
The impact of the Russia/Ukraine war, conflicts in the Middle East, and tension in the Taiwan strait, and related, downstream effects thereof, including disruptions to operations or the impact of sanctions on U.S. manufacturers doing business in these regions,
Protection of our intellectual property,
Our ability to comply with established and developing U.S. and foreign legal and regulatory requirements, including FCPA, EU MDR and similar laws in other jurisdictions,
Our ability to comply with U.S. and foreign export control, trade embargo and customs laws, and
The potential effect of foreign currency fluctuations and interest rate fluctuations on our net sales, operating expenses and resulting profit margins.
Liquidity
Our ability to generate sufficient cash flow to fund operations, capital expenditures, global expansion initiatives, any litigation settlements and judgments, share repurchases and strategic investments and acquisitions as well as maintaining our investment grade ratings and managing our debt levels and financial covenant compliance,
Our ability to access the public and private capital markets when desired and to issue debt or equity securities on terms reasonably acceptable to us,
The unfavorable resolution of open tax matters, exposure to additional tax liabilities and the impact of changes in U.S. and international tax laws,
The unfavorable resolution of open litigation matters, exposure to additional loss contingencies and legal provisions,
The impact of examinations and assessments by domestic and international taxing authorities on our tax provisions, financial condition or results of operations,
The possibility of counterparty default on our derivative financial instruments, and
Our ability to collect outstanding and future receivables and/or sell receivables under our factoring programs.
Boston Scientific Corporation published this content on November 03, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 03, 2025 at 11:32 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]