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What changed in Boston Scientific's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Boston Scientific's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+387 added−466 removedSource: 10-K (2026-02-17) vs 10-K (2025-02-18)

Top changes in Boston Scientific's 2025 10-K

387 paragraphs added · 466 removed · 303 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

47 edited+24 added−64 removed49 unchanged
Biggest changeOur product offerings include the following: 5 • the RESONATE™ family of implantable cardioverter defibrillators (ICD) and implantable cardiac resynchronization therapy defibrillators (CRT-D), including our proprietary HeartLogic™ Heart Failure (HF) Diagnostic and SmartCRT™ Technology with Multisite pacing in CRT-D, • EMBLEM™ MRI S-ICD Systems, the world's first commercially available subcutaneous implantable cardiac defibrillators (S-ICD), which provides physicians the ability to treat patients who are at risk for sudden cardiac arrest without touching the heart, • ACCOLADE™ family of pacemakers and implantable cardiac resynchronization therapy pacemakers (CRT-P), • ACUITY™ X4 Quadripolar LV Leads, RELIANCE™ family of ICD Leads and our INGEVITY™ Pacing Leads, • LATITUDE™ Remote Patient Management Systems, which allow for more frequent monitoring and better guided treatment decisions by enabling physicians to monitor implantable system performance remotely, • LUX-Dx™ II+™ Insertable Cardiac Monitor (ICM) System, a long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope and • BodyGuardian™ Remote Cardiac Monitoring Systems provide a full range of mobile health solutions and remote monitoring services, ranging from ambulatory cardiac monitors – including short and long-term holter monitors – to cardiac event monitors and mobile cardiac telemetry.
Biggest changeOur product offerings include implantable cardioverter defibrillators (ICD) (RESONATE™) and implantable cardiac resynchronization therapy defibrillators (CRT-D) (HeartLogic™ Heart Failure (HF) Diagnostic and SmartCRT™ Technology), subcutaneous implantable cardiac defibrillators (S-ICD) (EMBLEM™ MRI S-ICD System), which provide physicians the ability to treat patients who are at risk for sudden cardiac arrest without touching the heart, pacemakers and implantable cardiac resynchronization therapy pacemakers (CRT-P) (ACCOLADE™), remote patient management systems (LATITUDE™) and cardiac monitoring systems (BodyGuardian™ Remote Cardiac Monitoring Systems provide a full range of mobile health solutions and remote monitoring services), and our LUX-Dx II+™ Insertable Cardiac Monitor System, a long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as AF, cryptogenic stroke and syncope.
Although we believe our products and technologies generate favorable clinical outcomes, value and cost efficiency, while also being less invasive than alternatives, the resources necessary to demonstrate value to our customers, patients, payers and other stakeholders are significant and new therapies may take significantly longer periods of time to gain widespread adoption.
Although we believe our 9 products and technologies generate favorable clinical outcomes, value and cost efficiency, while also being less invasive than alternatives, the resources necessary to demonstrate value to our customers, patients, payers and other stakeholders are significant and new therapies may take significantly longer periods of time to gain widespread adoption.
We believe that our execution of these strategic imperatives will help us deliver on our mission, drive innovation and increase value for our customers and employees, while strengthening our leadership position in the medical device industry and delivering profitable revenue growth.
We believe that our 3 execution of these strategic imperatives will help us deliver on our mission, drive innovation and increase value for our customers and employees, while strengthening our leadership position in the medical device industry and delivering profitable revenue growth.
Our ERG chapters around the world collaborate across the business at all levels and are powerful drivers of change in the Company. 11 Additionally, our approach to supplier selection involves building inclusive practices throughout the Boston Scientific supplier network.
Our ERG chapters around the world collaborate across the business at all levels and are powerful drivers of change in the Company. Additionally, our approach to supplier selection involves building inclusive practices throughout the Boston Scientific supplier network.
In certain countries, and particularly in China, we also face competition from domestic medical device companies that may benefit from their status as local suppliers.
In certain countries, and particularly in China, we face competition from domestic medical device companies that may benefit from their status as local suppliers.
Our investment in research and development supports the following: • internal research and development programs, regulatory design and clinical science, as well as other programs obtained through our strategic acquisitions and alliances and • engineering efforts that incorporate customer feedback into continuous improvement efforts for currently marketed and next-generation products.
Our investment in research and development supports internal research and development programs, regulatory design and clinical science, and other programs obtained through our strategic acquisitions and alliances, as well as engineering efforts that incorporate customer feedback into continuous improvement efforts for currently marketed and next-generation products.
We have an ongoing supplier resiliency program which identifies and mitigates risk and have taken measures to mitigate the impact of challenges within the global supply chain in recent years. We consistently monitor our inventory levels, manufacturing, sterilization and distribution capabilities and partnerships and maintain recovery plans to address potential disruptions.
We have an ongoing supplier resiliency program which identifies and mitigates risk and have taken measures to mitigate the impact of challenges within the global supply chain in recent years. We consistently monitor our inventory levels, manufacturing, sterilization and distribution capabilities and partnerships and maintain recovery plans to address potential disruptions or material shortages.
Since the launch of the FARAPULSE™ PFA System, we have observed rapid conversion from legacy treatment modalities to PFA. It is now the predominant component of our Electrophysiology business unit and revenue.
Since the launch of the FARAPULSE™ PFA System in 2024, we have observed rapid conversion from legacy treatment modalities to PFA. It is now the predominant component of our Electrophysiology business unit and revenue.
Medical devices that have a valid CE Certificate to the Directives issued before May 2021 can continue to be sold during the applicable transition period or until the CE Certificate expires, whichever comes first, providing there are no significant changes to the design or intended use.
Medical devices that have a valid CE Certificate issued before May 2021 can continue to be sold during the applicable transition period or until the CE Certificate expires, whichever comes first, provided there are no significant changes to the design or intended use.
We are focused on continuous improvement in environmental metrics with a goal of reducing pollution, minimizing depletion of natural resources and reducing our overall environmental footprint. We have obtained ISO14001:2015, Environmental Management Standard certification for 18 of our key locations and ISO50001, Energy Management Standard certification for 13 of our key locations.
We are focused on continuous improvement in environmental metrics with a goal of reducing pollution, minimizing depletion of natural resources and reducing our overall environmental footprint. We have obtained ISO14001:2015, Environmental Management Standard certification for 18 of our key locations and ISO50001:2018, Energy Management Standard certification for 14 of our key locations.
As of December 31, 2024, we had approximately 53,000 employees, of which approximately 60 percent were outside the U.S. We believe the collective talent of our employees and our shared corporate culture, values and behaviors give us a competitive advantage. Attracting, developing and retaining talented employees are key parts of our strategy and are critical to our success.
As of December 31, 2025, we had approximately 59,000 employees, of which approximately 60 percent were outside the U.S. We believe the collective talent of our employees and our shared corporate culture, values and behaviors give us a competitive advantage. Attracting, developing and retaining talented employees are key parts of our strategy and are critical to our success.
Watchman Our WATCHMAN FLX™ and WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Devices are designed to close the left atrial appendage in patients with non-valvular atrial fibrillation who are at risk for ischemic stroke and eligible for anticoagulation therapy.
Watchman Our WATCHMAN™ Left Atrial Appendage Closure (LAAC) Devices are designed to close the left atrial appendage in patients with non-valvular atrial fibrillation (AF) who are at risk for ischemic stroke and eligible for anticoagulation therapy.
Urology Our Urology business unit 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.
Urology Our Urology business unit 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 male incontinence, over active bladder and pelvic floor disorders.
See Note I – Commitments and Contingencies to our 2024 consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K for a discussion of intellectual property, product liability and other litigation and proceedings in which we are involved.
See Note I – Commitments and Contingencies to our 2025 consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report for a discussion of intellectual property, product liability and other litigation and proceedings in which we are involved.
In addition to cash-based salaries, our rewards portfolio includes cash bonus programs, sales incentives, stock awards, recognition awards, health insurance, paid time off and family leave, retirement savings plans, childcare and employee assistance programs that encourage overall well-being, including help with finances, inclusive family planning and support, elder/childcare, legal support and mental health resources.
In addition to cash-based salaries, our rewards portfolio includes cash bonus programs, sales incentives, stock awards, recognition awards, health insurance, paid time off and family leave, retirement savings plans, childcare and employee assistance programs that encourage overall well-being, including help with finances, inclusive family planning and support, elder/childcare, legal support and mental health resources. 10 Equal pay for equal work is rooted in our values and foundational to fostering an inclusive environment.
We are also required to comply with the regulations of every other country where we commercialize products before we can launch or maintain new products on the market, including regulations that have been introduced in many countries in the Middle East and Southeast Asia that previously did not have medical device regulations, or had minimal regulations.
We are also required to comply with the regulations of every other country where we commercialize products before we can launch or maintain new products on the market, including NMPA regulations in China, Ministry of Health, Labour and Welfare (MHLW) and PMDA regulations in Japan, and regulations in many countries in the Middle East and Southeast Asia that previously did not have, or had minimal, medical device regulations.
Equal pay for equal work is rooted in our values and foundational to fostering an inclusive environment. Pay equity is an important part of our long-standing global compensation planning practices. Sustaining pay equity requires constant measurement and attention, so we regularly conduct comprehensive audits, internal and external analyses and company-wide benchmarking of salaries to identify and mitigate disparities.
Pay equity is an important part of our long-standing global compensation planning practices. Sustaining pay equity requires constant measurement and attention, so we regularly conduct comprehensive audits, internal and external analyses and company-wide benchmarking of salaries to identify and mitigate disparities.
Predictability in the supply of certain raw materials and components used in the manufacturing of our products has improved but continues to be a risk for certain materials and vendors.
Supply of certain raw materials and components used in the manufacturing of our products has been stable, but there continues to be risk for certain materials and vendors.
Workforce Development We do our best work to advance health care when we have a diverse range of perspectives and experience on our team. Innovation thrives in a culture of engagement and inclusion.
Workforce Development We do our best work to advance health care when we have a diverse range of perspectives and experience on our team. Innovation thrives in a culture of engagement and inclusion. We continue to focus on improving workforce development through intentional actions to drive meaningful change.
Available Information Copies of our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act), are available free of charge on our website (www.bostonscientific.com) as soon as reasonably practicable after we electronically file the material with or furnish it to the U.S.
We also support Science, Technology, Engineering and Mathematics (STEM) education initiatives designed to engage underrepresented students through employee-led outreach. 11 Available Information Copies of our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act), are available free of charge on our website (www.bostonscientific.com) as soon as reasonably practicable after we electronically file the material with or furnish it to the U.S.
Focused, cross-functional teams take a formal approach to new product design and development, helping us to manufacture and offer innovative products consistently and efficiently. Involving cross-functional teams early in the process is the cornerstone of our product development cycle.
We conduct our internal research and development activities at our facilities and centers of excellence located around the world. Focused, global cross-functional teams take a formal approach to new product design and development, helping us to manufacture and offer innovative products consistently and efficiently. Involving cross-functional teams early in the process is the cornerstone of our product development cycle.
We maintain a global Government Affairs presence, headquartered in Washington, D.C., to actively monitor and advocate on myriad legislation and policies that may potentially impact us, both on a domestic and an international front.
We maintain a global Government Affairs presence, headquartered in Washington, D.C., to actively monitor and advocate on myriad legislative matters and public policies that may potentially impact us and the patients we serve, both domestically and in international markets.
We continue to focus on improving workforce development through intentional actions to drive meaningful change. We listen to our employees and use that feedback to complement and expand our existing programs to emphasize initiatives aimed at developing our pipeline of talent and fostering an inclusive workplace for all.
We listen to our employees and use that feedback to complement and expand our existing programs to emphasize initiatives aimed at developing our pipeline of talent and fostering an inclusive workplace for all.
Our primary competitors include large manufacturers with multiple lines of business and competing products, as well as a wide range of medical device companies that sell a single or limited number of competitive products or participate in only a specific market segment.
Our primary competitors include large manufacturers with multiple lines of business and competing products, as well as a wide range of medical device companies that sell a single or limited number of competitive products or participate in only a specific market segment. We also encounter competition from the entry of low-cost manufacturers, which may lead to increased pricing pressure.
Our product offerings include the following: • a comprehensive line of stone management products, including ureteral stents, catheters, baskets, guidewires, sheaths and balloons, • LithoVue™ Single-Use Digital Flexible Ureteroscopes, which deliver detailed high-resolution digital images for high-quality visualization and seamless navigation, • Lumenis Pulse™ Holmium Laser Systems with MOSES ™ Technology, complemented by a full line of laser fibers and accessories used in urology procedures, • our prosthetic urology portfolio, which includes our AMS 700™ penile implant with the TENACIO™ pump to treat erectile dysfunction and our AMS 800™ Artificial Urinary Sphincter to treat male urinary incontinence, • GreenLight XPS™ Laser System and Rezūm™ Systems for treatment of BPH and • SpaceOAR™ Hydrogel Systems which help reduce side effects that men may experience after receiving radiotherapy to treat prostate cancer, together with our SpaceOAR VUE™ Hydrogel, providing clinicians with enhanced product visualization.
Our product offerings include a comprehensive line of stone management products, including ureteral stents, catheters, baskets, guidewires, sheaths and balloons, single-use digital flexible ureteroscopes (LithoVue™), laser systems used in urology procedures (Lumenis Pulse™ Holmium Laser Systems with MOSES ™ Technology), and for the treatment of BPH ( GreenLight XPS™ Laser System and Rezūm™ Systems), our portfolio of prosthetic urology products (including AMS 700™ Penile Implant with the TENACIO™ Pump to treat erectile dysfunction and our AMS 800™ Artificial Urinary Sphincter to treat male urinary incontinence), hydrogel systems which help reduce side effects that men may experience after receiving radiotherapy to treat prostate cancer (SpaceOAR™), and our portfolio of products to treat pelvic floor disorders, including our Axonics™ Sacral Neuromodulation System (Axonics™) and our Bulkamid™ Uretheral Bulking System. 4 Neuromodulation Our Neuromodulation business unit develops and manufactures devices to treat various neurological movement disorders and manage chronic pain.
We continue to educate and train our people, update policies and expand benefits to decrease bias, ensure our employee base represents the patients, health systems and communities we serve, and foster a culture where all employees feel valued and included.
We continue to educate, update policies and expand benefits to ensure our employee base represents the patients, health systems and communities we serve, and foster a culture of inclusion.
Securities and Exchange Commission (SEC). Additionally, the SEC maintains an internet site (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.
Securities and Exchange Commission (SEC). Additionally, the SEC maintains an internet site (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Information on our website or linked to our website is not incorporated by reference into this Annual Report. 12
The CE Mark, which is required to sell medical devices in the EU is affixed following a Conformity Assessment and either approval from the appointed independent Notified Body or through self-certification by the manufacturer. The selected pathway to CE marking is based on device risk classification.
In the European Union (EU), a CE Mark is required to sell medical devices, which represents that products meet required standards of performance, safety, and quality. A CE Mark is affixed following a conformity assessment and either approval from an appointed independent notified body or through self-certification by the manufacturer.
While our consolidated net sales do not reflect any significant degree of seasonality, customer purchases of our medical devices have historically been lower in the first and third quarters of the year.
Seasonality Our net sales are influenced by many factors, including product launches, acquisitions, regulatory and reimbursement approvals, patient, physician and employee holiday schedules and other macro-economic conditions. While our consolidated net sales do not reflect any significant degree of seasonality, customer purchases of our medical devices have historically been lower in the first and third quarters of the year.
Our product offerings include the following: • FARAPULSE™ Pulsed Field Ablation (PFA) System for the treatment of AF, • POLARx™ Cryoablation Systems for the treatment of AF, • VersaCross Connect™ Access Solutions for our WATCHMAN FXD Curve™ Sheath, Polarsheath™ and Faradrive™ Steerable Sheath providing safe and efficient access to the left side of the heart, • OPAL HDx™ Mapping System, catheter-based, 3-D cardiac mapping and navigation solutions designed to help diagnose and guide treatment of a variety of arrhythmias, • a portfolio of radiofrequency (RF) cardiac ablation catheters, including our INTELLANAV STABLEPOINT™ catheter, which also includes DIRECTSENSE™ Software for monitoring RF energy during ablations and • IntellaMap Orion™ Mapping Catheters, for use with our OPAL HDx™ Mapping System to provide high-density, high-resolution maps of the heart.
Our product offerings include our FARAPULSE™ Pulsed Field 5 Ablation (PFA) System for the treatment of AF, our OPAL HDx™ Mapping System, offering catheter-based, 3-D cardiac mapping and navigation solutions, our VersaCross Connect™ Access Solutions portfolio, Polarsheath™ and Faradrive™ Steerable Sheath providing safe and efficient access to the left side of the heart, and our portfolio of cyroablation and radiofrequency cardiac ablation systems for the treatment of AF.
Peripheral Interventions Our Peripheral Interventions business unit 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.
Interventional Oncology and Embolization Our Interventional Oncology and Embolization business unit develops and manufactures products to treat various forms of cancer.
This includes taking actions to advance diversity and inclusion, including through financial support of equity initiatives in the communities where we live and work, protecting the environment, investing in our employees' health and well-being, and many other initiatives that we believe ultimately help us create value responsibly.
This includes taking actions to drive innovative care, contribute to the communities where we live and work, protect the environment, invest in our employees' health and well-being, and many other initiatives that we believe ultimately help us create value responsibly. Refer to Corporate Responsibility below for additional information regarding measures we are undertaking.
Regulatory Environment Medical Device Regulatory Approvals The medical devices that we manufacture, market and commercialize are subject to regulation by numerous worldwide regulatory bodies, including the FDA and comparable international regulatory agencies. These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing development, testing, manufacturing, labeling, marketing and distribution.
These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing development, testing, manufacturing, labeling, marketing and distribution. Medical devices are also generally subject to varying levels of regulatory control based on risk level of the device.
Our product offerings include the following: • Resolution 360™ Clips, Resolution 360™ ULTRA Clips and MANTIS™ Clips, hemostatic clipping technology designed to stop and help prevent bleeding during endoscopic procedures, • WallFlex™ Biliary Stent Systems, used for relieving biliary obstructions by providing bile drainage in both malignant and benign strictures, 3 • AXIOS™ Stents and Electrocautery Enhanced Delivery Systems, the first, and currently only stent systems in the U.S. indicated for endoscopic drainage of pancreatic pseudocysts and used to facilitate endoscopic drainage of the gallbladder for patients with acute cholecystitis, • SpyGlass™ DS II Direct Visualization Systems and SpyGlass™ Discover Digital Catheters, the first single-use scopes to enable physicians to take a single-stage approach to diagnostic and therapeutic procedures in the pancreaticobiliary system, including treating patients with bile duct stones, • EXALT™ Model D Single-Use Duodenoscopes for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures, the first U.S.
Our product offerings include hemostatic clips designed to stop and help prevent bleeding during endoscopic procedures (Resolution 360™ and MANTIS™ Clips), stent systems used for relieving biliary obstructions (WallFlex™ Biliary Stent Systems) and for endoscopic drainage of pancreatic pseudocysts (AXIOS™ Stents and Electrocautery Enhanced Delivery Systems), single-use scopes used for diagnostic and therapeutic procedures in the pancreaticobiliary system (SpyGlass™), and in endoscopic retrograde cholangiopancreatography (ERCP) procedures (EXALT™ Model D Single-Use Duodenoscopes), our portfolio of endoluminal surgery products (OverStitch™ Endoscopic Suturing System and Orbera™ Intragastric Balloon System) and our portfolio of infection prevention products.
We are committed to the sustained support of a broad spectrum of businesses that share our dedication to improving the quality of patient care. Compensation and Benefits We offer competitive, performance-based compensation programs, recognizing that employee well-being, safety, culture, engagement and recognition are all critical to a healthy work environment and productive workforce.
We are committed to the sustained support of a broad spectrum of businesses that share our dedication to improving the quality of patient care. Compensation and Benefits We offer competitive pay and benefits that are flexible and affordable to meet the individual needs of our employees.
In addition to encouraging ongoing communication and feedback between employees and their managers, we conduct periodic employee engagement surveys to ensure all employees have an opportunity to share their insights and we take appropriate action in response. 12 Community Outreach We are united by a goal to make a difference in the lives of the over 44 million patients we serve annually.
In addition to encouraging ongoing communication and feedback between employees and their managers, we conduct periodic employee engagement surveys to ensure all employees have an opportunity to share their insights and we take appropriate action in response. Corporate Responsibility As a global health care company, we seek to meet patient needs while integrating responsible practices across our business.
In addition, other EU countries continue to impose significant local registration requirements despite the implementation of MDR, and the United Kingdom has introduced new requirements following its exit from the EU.
The CE mark continues to be a prerequisite for successful registration in many other global geographies. In addition, other EU countries continue to impose significant local registration requirements despite the implementation of MDR.
Many components used in the manufacturing of our products are readily fabricated from commonly available raw materials or off-the-shelf items available from multiple supply sources; however, certain items are custom made to meet our specifications. 8 On an on-going basis, we track supplier status and inventory in risk areas and take action to prevent shortages, monitoring safety stock levels and building up product supplies as warranted, and mitigating risk of technology and material shortages by identifying new vendors.
Many components used in the manufacturing of our products are readily fabricated from commonly available raw materials or off-the- 7 shelf items available from multiple supply sources; however, certain items are custom made to meet our specifications, and certain materials and components are purchased from single sources due to quality considerations, expertise, costs or constraints resulting from regulatory requirements.
Employee Health and Safety We take a global approach to prioritizing and monitoring employee health and safety and we strive to foster a safety-oriented culture in all of our offices and facilities. We set health and safety goals which measure the number of injuries per 100 employees for the global organization.
Employee Health, Safety and Well-Being We take a global approach to prioritizing and monitoring employee health and safety and we strive to foster a safety-oriented culture in all of our offices and facilities. We maintain rigorous health and safety standard protocols across our businesses and regions that are designed to align with regulatory requirements and industry best practices.
Our venous disease product offerings include the following: • AngioJet™ Thrombectomy Systems, used in endovascular procedures to remove blood clots from blocked arteries and veins and our AngioJet Zelante DVT™ Thrombectomy Catheters to treat deep vein thrombosis, • EKOS™ Ultrasound Assisted Thrombolysis systems used to treat pulmonary embolisms and • Varithena™ Polidocanol Injectable Foam used to improve the symptoms of superficial venous incompetence and the appearance of visible varicosities.
In addition, the portfolio comprises minimally invasive therapies to remove or dissolve blood clots in deep veins and pulmonary arteries (AngioJet™ Thrombectomy Systems and EKOS™ Ultrasound Assisted Thrombolysis) and injectable treatments that improve symptoms associated with superficial venous reflux and varicose veins (Varithena™ Polidocanol Injectable Foam).
For novel 9 technologies, the FDA may seek input from an advisory panel of medical experts and seek their views on the safety, effectiveness and benefit-risk of the device. The PMA process is generally more detailed, lengthier and more expensive than the 510(k) process.
The PMA approval process generally requires clinical data to support the safety and effectiveness of the device, and is generally more detailed, lengthier and more expensive than the 510(k) process.
We recognize that our continued competitive success will depend upon our ability to: • offer products and solutions that provide differentiated clinical and economic outcomes, • create or acquire innovative, scientifically advanced technologies, • apply our technology and solutions cost-effectively and with superior quality across product lines and markets, • develop or acquire proprietary products and solutions, • attract and retain qualified personnel, 7 • obtain patent or other protection for our products, • obtain required regulatory and reimbursement approvals, • continually provide quality products and enhance our quality systems and • supply sufficient inventory at competitive prices to meet customer demand.
Our competitive success depends upon our ability to continue to offer products and solutions that provide differentiated clinical and economic outcomes, including developing or acquiring innovative, scientifically advanced technologies, attract and retain qualified personnel, protect the intellectual property of our products, obtain required regulatory and reimbursement approvals, maintain our quality systems and provide quality products, and successfully market our products and meet customer demand. 6 Research and Development Our investment in research and development is critical to driving our future growth.
Cardiovascular Cardiology Interventional Cardiology Therapies (ICTx) Our Interventional Cardiology Therapies business unit develops and manufactures technologies for diagnosing and treating coronary artery disease and aortic valve conditions.
Cardiovascular Interventional Cardiology and Vascular Therapies (ICVT) Our Interventional Cardiology and Vascular Therapies business unit develops and manufactures technologies to diagnose and treat complex coronary, peripheral and venous diseases, including calcific and obstructive arterial disease, thromboembolic conditions and venous insufficiency.
The first process requires that a premarket notification (510(k)) be made to the FDA to demonstrate that the device is as safe and effective as, or substantially equivalent to, a legally marketed device (the “predicate” device). Applicants must submit performance data to establish substantial equivalence.
In the United States, we must receive authorization from the FDA to distribute our products, which is typically obtained through either a premarket notification (510(k)) to demonstrate that the device is as safe and effective as, or substantially equivalent to, a legally marketed device, or a premarket approval (PMA) application to demonstrate that the device is safe and effective for its intended use.
In the first quarter of 2024, we commenced the U.S. launch of the FARAPULSE™ PFA System. We received National Medical Products Administration (NMPA) approval in China and Pharmaceuticals and Medical Device Agency (PMDA) approval in Japan in the second and third quarter of 2024, respectively.
We received FDA approval in the United States, and Pharmaceuticals and Medical Device Agency (PMDA) approval in Japan, in the second and third quarters of 2025, respectively, to expand instructions for use labeling to include the treatment of drug refractory, symptomatic persistent AF with the FARAPULSE™ PFA System.
MDR also modifies and increases the compliance requirements for the medical device industry and has required significant investment and will continue to require ongoing investment over the next few years to transition all products. The CE mark continues to be a prerequisite for successful registration in many other global geographies.
In 2023, the European Commission extended the transitional period to 2027 for certain high risk class devices and 2028 for lower risk class medical devices. The MDR has required significant investment and will continue to require ongoing investment over the next couple of years to transition all products.
Our Employee Health & Safety Global and Regional Councils review performance monthly to discuss trends and risks, as well as opportunities for improvement. We have obtained ISO 45001:2018 Occupational Health and Safety Management System at 17 of our key global locations.
Our Employee Health & Safety Global and Regional Councils meet regularly to review our performance against health and safety goals for the global organization and to discuss trends and risks, as well as opportunities for improvement. We recognize that employee well-being, safety, culture, engagement and recognition are all critical to a healthy work environment and productive workforce.
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Refer to discussion of Community Outreach and Corporate Responsibility below for additional information regarding measures we are undertaking. Product Offerings Our core businesses are organized into two reportable segments: MedSurg and Cardiovascular. The following describes our key product offerings and new product innovations by reportable segment and business unit.
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Product Offerings Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Our core businesses are organized into two reportable segments: MedSurg and Cardiovascular. In the fourth quarter of 2025, an organizational change combined our legacy Cardiology and Peripheral Interventions businesses into a single Cardiovascular business.
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MedSurg Endoscopy Our Endoscopy business unit develops and manufactures devices to diagnose and treat a broad range of gastrointestinal (GI) conditions with innovative, less-invasive technologies.
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The change had no impact on our reportable segments. The following describes our key product offerings and new product innovations by reportable segment and business unit. MedSurg Endoscopy Our Endoscopy business unit develops and manufactures minimally invasive devices for diagnosing and treating gastrointestinal and pancreaticobiliary conditions and for supporting weight loss in patients with obesity.
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Food and Drug Administration (FDA)-cleared single-use (disposable) duodenoscopes on the market, • our endoluminal surgery portfolio, including our OverStitch™ Endoscopic Suturing System, used to close gastrointestinal defects and our endobariatric portfolio, including our Orbera™ Intragastric Balloon System used to aid in weight loss for patients suffering from obesity and • our infection prevention portfolio, designed to minimize the risk of infection transmission and improve operational efficiencies by streamlining manual cleaning or eliminating the need for cleaning and tracking.
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Our product offerings include our WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System, designed to provide improved pain relief to a wide range of patients who suffer from chronic pain, our Intracept™ Intraosseous Nerve Ablation System, the only U.S.
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In the fourth quarter of 2024, we completed the acquisition of Axonics, Inc. (Axonics), a publicly traded medical technology company primarily focused on the development and commercialization of devices to treat urinary and bowel dysfunction.
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Food and Drug Administration (FDA)-cleared system to treat vertebrogenic pain, a form of chronic low back pain, our G4™ Generator and consumable portfolio in Radiofrequency Ablation (RFA) for pain management and our Vercise Genus™ Deep Brain Stimulation (DBS) System for the treatment of Parkinson's disease, tremor and intractable primary and secondary dystonia.
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The Axonics product portfolio includes the Axonics R20™ and Axonics F15™ Systems used to deliver sacral neuromodulation (SNM) therapy for the treatment of over-active bladder and fecal incontinence. Neuromodulation Our Neuromodulation business unit develops and manufactures devices to treat various neurological movement disorders and manage chronic pain.
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Our portfolio includes intravascular imaging and multi-modality guidance systems that enhance procedural visualization and decision-making (OptiCross™ IVUS Imaging Catheters and AVVIGO™+ Multi-Modality Guidance System), vessel preparation and plaque modification technologies for heavily calcified and resistant coronary lesions (ROTAPRO™ Rotational Atherectomy Systems and WOLVERINE™ Coronary Cutting Balloon), coronary drug-eluting and drug-coated therapies designed to treat coronary arterial disease and in-stent restenosis (SYNERGY™ Everolimus-Eluting Stent Systems and AGENT™ Drug-Coated Balloon) and peripheral vascular therapies for the treatment of peripheral artery disease (Eluvia™ Drug-Eluting Vascular Stent Systems and Ranger™ Drug-Coated Balloons).
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Our product offerings include the following: • WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System, designed to provide improved pain relief to a wide range of patients who suffer from chronic pain, with proprietary features such as Multiple Independent Current Control, our Illumina 3D™ Proprietary Programming Software and FAST™ Therapy for profound parathesia-free pain relief in minutes, used by physicians to target specific areas of pain and customize stimulation of nerve fibers more precisely, • our G4™ Generator and consumable portfolio in Radiofrequency Ablation (RFA) for pain management used by physicians to treat patients with chronic pain, • Superion™ Indirect Decompression Systems, minimally-invasive devices used to improve physical function and reduce pain in patients with moderate lumbar spinal stenosis (LSS), • our Intracept™ Intraosseous Nerve Ablation System, the only FDA-cleared system to treat vertebrogenic pain, a form of chronic low back pain and • Vercise Genus™ Deep Brain Stimulation (DBS) System for the treatment of Parkinson's disease, tremor and intractable primary and secondary dystonia, a neurological movement disorder characterized by involuntary muscle contractions, utilizing Stimview™ XT, our proprietary DBS visualization software developed in collaboration with Brainlab AG, providing clinicians with real-time, 3D visualization and stimulation of brain anatomy. 4 In the first quarter of 2024, we received FDA approval for an expanded indication of the WaveWriter™ SCS Systems for the treatment of chronic low back and leg pain in people who have not had prior back surgery.
Added
In the second quarter of 2025, we completed our acquisition of the remaining shares of Bolt Medical, Inc. (Bolt Medical), the developer of an intravascular lithotripsy advanced laser-based platform for the treatment of coronary and peripheral artery disease. In addition, we completed the acquisition of the remaining shares of SoniVie Ltd.
Removed
Our product offerings include the following: • OptiCross™ Intravascular Ultrasound (IVUS) Imaging Catheters, • iLab™ Ultrasound Imaging Systems with Polaris Software, designed to enhance the diagnosis and treatment of blocked vessels and other heart disorders, compatible with our full line of imaging catheters, • AVVIGO™+ Multi-Modality Guidance System, incorporating high-definition IVUS all in a mobile or integrated platform, • ROTAPRO™ Rotational Atherectomy Systems, designed to treat coronary calcification in lesions by regulating the flow of air to the advancer, controlling burr rotation speed, and also monitoring and displaying burr rotation speed and rotational atherectomy procedural time, • SYNERGY™, SYNERGY MEGATRON™ and SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent Systems, featuring an ultra-thin abluminal (outer) bioabsorbable polymer coating, • Safari2™ Pre-Shaped Guidewires, intended to facilitate the introduction and placement of interventional devices within the heart, • WOLVERINE™ Coronary Cutting Balloon™, a cutting balloon angioplasty device with a unique mechanism of action that enables precise vessel preparation across a wide range of resistant lesions, • AGENT™ Drug-Coated Balloon, which is designed to provide a targeted, therapeutic dose of anti-proliferative paclitaxel to the coronary lesion and minimize downstream particulates, • ACURATE neo2 ™ and ACURATE Prime™ Aortic Valve Systems for use in transcatheter aortic valve replacement (TAVR) procedures and • SENTINEL™ Cerebral Embolic Protection Systems, used to reduce the risk of stroke in TAVR procedures and is clinically proven to decrease cerebral embolization and its associated neurological effects.
Added
(SoniVie), a privately held medical device company that has developed the TIVUS™ Intravascular Ultrasound System. An investigational technology, the TIVUS System is designed to denervate nerves surrounding blood vessels to treat a variety of hypertensive disorders, including renal artery denervation for hypertension.
Removed
In the first quarter of 2024, we received FDA approval of the AGENT™ Drug-Coated Balloon, the first drug-coated coronary balloon in the U.S., which is indicated to treat in-stent restenosis in patients with coronary artery disease and in the second quarter of 2024, initiated the U.S. launch.
Added
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 innovative medical thrombectomy products for use in peripheral vascular procedures in the removal of blood clots and blockages.
Removed
In addition, in the third quarter of 2024, we received CE Mark and initiated the European launch of the ACURATE™ Prime™ Aortic Valve System, the company's next-generation transcatheter aortic valve replacement technology designed to treat severe aortic stenosis in patients across all surgical risk levels while also expanding the treatment range to patients with a larger anatomy.
Added
The Penumbra portfolio includes the Lightning Bolt™ and Lightning Flash™ Computer Assisted Vacuum Thrombectomy (CAVT™) Systems. The purchase price is valued at $374 per share, or approximately $14.500 billion. The transaction is expected to close during 2026, subject to customary closing conditions.
Removed
In the first quarter of 2024, we received FDA clearance and initiated the U.S. launch of the WATCHMAN TruSteer™ Access System, a steerable sheath designed to improve implant success of the WATCHMAN FLX™ Pro and WATCHMAN FLX™ LAAC Devices.
Added
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.
Removed
In the third quarter of 2024, we received CE Mark for the LUX-Dx II/II+™ ICM system for long-term monitoring of arrhythmias.
Added
In the second quarter of 2025, we received CE mark for the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device, which is optimized for healing and designed to improve visualization during device placement and treat a broader range of patient anatomies.
Removed
In addition, in the third quarter of 2024, we received FDA approval to expand the indication for the current-generation INGEVITY™+ Pacing Leads to include conduction system pacing and sensing of the left bundle branch area of the heart when connected to a single-or dual-chamber pacemaker.
Added
Our portfolio includes technologies used to treat liver cancer, including radioactive glass microsphere therapy for primary liver cancer (TheraSphere™ Y-90) and hepatic arterial infusion systems for secondary liver and bile duct cancers, as well as cryoblation systems for the treatment of kidney, bone and lung cancers.
Removed
In addition, in the third quarter of 2024, we received FDA approval for the navigation-enabled FARAWAVE™ NAV Ablation Catheter for the treatment of paroxysmal AF and FDA 510(k) clearance for the new FARAVIEW™ Software, which combine to provide visualization for cardiac ablation procedures with the OPAL HDx™ Mapping System.
Added
The portfolio also comprises embolization devices used in arterial and venous procedures across the peripheral vasculature (EMBOLD™ Detachable Coil System). Markets Competition We encounter significant competition across our business segments, product lines and markets, from global and local competitors.
Removed
Our broad peripheral portfolio includes stent systems, balloon catheters, guidewires, atherectomy and thrombectomy systems, embolization devices, radioactive microspheres, radiofrequency and cryotherapy ablation systems, microcatheters, drainage catheters and transcarotid artery revascularization. 6 Our peripheral arterial product offerings include: • Eluvia™ Drug Eluting Vascular Stent Systems, innovative stents built on the Innova stent platform, designed to deliver a sustained dosage of paclitaxel during the time when restenosis is most likely to occur, in addition to the Eluvia™ line extension, the longest-length stent available for treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery, • Mustang™, Coyote™ and Sterling™ PTA Balloon Catheters designed for a wide variety of peripheral angioplasty procedures and • Ranger™ Drug-Coated Balloons, innovative balloons built on the Sterling balloon platform, featuring a low-dose of paclitaxel.
Added
Regulatory Environment As a global company, we are governed by federal, state, local and international laws of general applicability relating to, among other things, employment, labor, privacy and data protection, governance and securities, anti-corruption, fraud and abuse (including anti-kickback and false claims laws), competition, trade and export controls.
Removed
Our interventional oncology and embolization product offerings include the following: • TheraSphere™ Y-90 radioactive glass microspheres used in the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer, • Renegade™ HI-FLO™ Microcatheter and Fathom™ Guidewire System and Interlock™ - 35 Fibered IDC™ and Interlock™ - 18 Fibered IDC™ Occlusion System for peripheral embolization, • EMBOLD™ Detachable Coil System, used for arterial and venous embolizations in the peripheral vasculature and • ICEFX™ and Visual ICE™ Cryoablation Systems for destruction of tissue, using image-guided needles to enable cryoablation visualization for optimal tumor coverage .
Added
In general, the scope and complexity of regulations applicable to our business has increased over time. We anticipate that governmental authorities will continue to scrutinize our industry closely and that additional regulation may increase compliance and legal costs. Any adverse regulatory actions or exposure to litigation could have an adverse effect on our business, results of operations or financial condition.
Removed
In the third quarter of 2024, we completed our acquisition of Silk Road Medical, Inc. (Silk Road Medical), a publicly traded medical device company that has developed an innovative platform of products to prevent stroke in patients with carotid artery disease through a minimally-invasive procedure called transcarotid artery revascularization.
Added
Medical Device Regulations The medical devices that we manufacture, market and commercialize are subject to regulation by numerous worldwide regulatory bodies, including the FDA in the United States, the European Medicines Agency (EMA) in Europe and other comparable international regulatory agencies.
Removed
Markets Competition We encounter significant competition across our product lines and in each market in which we sell our products and solutions, some from companies that may have greater financial, sales and marketing resources than we do.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

84 edited+13 added−21 removed150 unchanged
Biggest changeWhile we expect limited role reductions as a result of these restructuring activities, we anticipate that our overall employee base will remain relatively unchanged upon completion of the 2023 Restructuring Plan as new jobs are created in areas of growth and resources are deployed to support an expanding portfolio and growing global market needs. 22 These measures could yield unintended consequences, such as distraction of our management and employees, reduced employee productivity, business disruption, and inability to attract or retain key personnel, which could negatively affect our business, sales, financial condition and results of operations.
Biggest changeThese measures and any future restructuring and optimization initiatives could yield unintended consequences, such as distraction of our management and employees, reduced employee productivity, business disruption, and inability to attract or retain key personnel, which could negatively affect our business, sales, financial condition and results of operations.
Our international operations are subject to a number of market, business and financial risks and uncertainties, including those related to our use of channel partners, go-to-market strategies, geopolitical and economic instability, foreign currency exchange and interest rate fluctuations, competitive product offerings, local changes in health care financing and payment systems and health care delivery systems, local product preferences and requirements, including preferences for local manufacturers, trade protection measures, including tariffs or other barriers to market participation, workforce instability, weaker intellectual property protection in certain countries than exists in the U.S. and longer accounts receivable cycles.
Our international operations are subject to a number of market, business and financial risks and uncertainties, including those related to our use of channel partners, go-to-market strategies, geopolitical and economic instability, foreign currency exchange and interest rate fluctuations, competitive product offerings, local changes in health care financing and payment systems and health care delivery systems, local product preferences and requirements, including preferences for local manufacturers, trade protection measures, including tariffs and other barriers to market participation, workforce instability, weaker intellectual property protection in certain countries than exists in the U.S. and longer accounts receivable cycles.
Some of the factors that could affect the success of our acquisitions include, among others, the effectiveness of our due diligence process, our ability to execute our business plan for the acquired companies, the strength of the acquired technology, results of clinical trials, regulatory approvals and reimbursement levels of the acquired 21 products and related procedures, the continued performance of critical transition services, our ability to adequately fund acquired in-process research and development projects and retain key employees and our ability to achieve synergies with our acquired companies, such as increasing sales of our products, achieving cost savings and effectively combining technologies to develop new products.
Some of the factors that could affect the success of our acquisitions include, among others, the effectiveness of our due diligence process, our ability to execute our business plan for the acquired companies, the strength of the acquired technology, results of clinical trials, regulatory approvals and reimbursement levels of the acquired products and related procedures, the continued performance of critical transition services, our ability to adequately fund acquired in-process research and development projects and retain key employees and our ability to achieve synergies with our acquired companies, such as increasing sales of our products, achieving cost savings and effectively combining technologies to develop new products.
Any failure by us to maintain 24 or protect our IT or OT systems, products and data integrity, including from cyber-attacks, intrusions or other breaches, could result in outages or unauthorized access to patient data and personally identifiable information, theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our operations, or, in the worst case, could result in harm to patients.
Any failure by us to maintain or protect our IT or OT systems, products and data integrity, including from cyber-attacks, intrusions or other breaches, could result in outages or unauthorized access to patient data and personally identifiable information, theft of intellectual property or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our operations, or, in the worst case, could result in harm to patients.
These conditions could affect our ability to access credit markets, including to obtain financing for mergers 19 and acquisitions (M&A) or for other general purposes. These conditions may adversely affect our suppliers, leading them to experience financial difficulties or be unable to borrow money to fund their operations, which could cause disruptions in our ability to produce our products.
These conditions could affect our ability to access credit markets, including to obtain financing for mergers and acquisitions (M&A) or for other general purposes. These conditions may adversely affect our suppliers, leading them to experience financial difficulties or be unable to borrow money to fund their operations, which could cause disruptions in our ability to produce our products.
Failure to meet growth projections, poor clinical outcomes, increasing regulatory requirements, launch delays and inability to effectively scale manufacturing and achieve targeted margins with respect to any of these products or groups of products in particular may materially adversely impact on our business, financial condition and results of operations.
Failure to meet growth projections, poor clinical outcomes, increasing regulatory requirements, approval and launch delays and inability to effectively scale manufacturing and achieve targeted margins with respect to any of these products or groups of products in particular may materially adversely impact on our business, financial condition and results of operations.
Tax laws and regulations could change on a prospective or retroactive basis and any such changes could have a material adverse effect on our financial condition and results of operations. Following the issuance of any new law or regulation, interpretations are made by the Company, using any regulatory guidance and judicial interpretations issued after the law change.
Tax laws and regulations could change on a prospective or retroactive basis, and any such changes could have a material adverse effect on our financial condition and results of operations. Following the issuance of any new law or regulation, interpretations are made by the Company, using any regulatory guidance and judicial interpretations issued after the 23 law change.
Increased environmental regulation, including to address climate change, as well as new disclosure and reporting requirements in the U.S. and other jurisdictions, including with respect to climate change and carbon emissions, may result in increases in our or our suppliers' compliance burdens and costs to operate our business, or restrict certain aspects of our activities.
Increased environmental regulation, including to address climate change, as well as new disclosure and reporting requirements in the U.S., EU and other jurisdictions, including with respect to climate change and carbon emissions, may result in increases in our or our suppliers' compliance burdens and costs to operate our business, or restrict certain aspects of our activities.
Accordingly, the outcomes of individual cases are difficult to time, predict or quantify and are often dependent upon the outcomes of other cases in other geographies. A number of third parties have asserted that our current and former product offerings infringe patents owned or licensed by them.
Accordingly, the outcomes of 24 individual cases are difficult to time, predict or quantify and are often dependent upon the outcomes of other cases in other geographies. A number of third parties have asserted that our current and former product offerings infringe patents owned or licensed by them.
Delays in our product development and new product launches could result in disruption in our cash flow or our ability to continue to effectively manage our debt levels, which could have an adverse effect on our cost of borrowing, financial condition or results of operations.
Delays in product development and new product approvals and launches could result in disruption in our cash flow or our ability to continue to effectively manage our debt levels, which could have an adverse effect on our cost of borrowing, financial condition or results of operations.
No assurance can be made that any pending or future patent 29 applications will result in the issuance of patents, that any current or future patents issued to, or licensed by, us will not be challenged or circumvented by our competitors, or that our patents will not be found invalid.
No assurance can be made that any pending or future patent applications will result in the issuance of patents, that any current or future patents issued to, or licensed by, us will not be challenged or circumvented by our competitors, or that our patents will not be found invalid.
Some of our IT and OT systems contain legacy third-party software components for which we depend on a layered security approach to protect against exploitation, and such layered security approach may not be effective.
Some of our IT and OT systems contain legacy third-party software components for which we depend on a layered security 19 approach to protect against exploitation, and such layered security approach may not be effective.
Product liability claims, securities and commercial litigation and other litigation in the future, regardless of the outcome, could have a material adverse effect on our financial condition, results of operations or liquidity.
Product liability claims, securities, commercial and environmental litigation and other litigation in the future, regardless of the outcome, could have a material adverse effect on our financial condition, results of operations or liquidity.
Additionally, we maintain an insurance policy providing limited coverage against securities claims and we are substantially self-insured with respect to product liability claims and fully self-insured with respect to intellectual property infringement claims.
Additionally, we maintain an insurance policy providing limited coverage against securities claims and we are substantially self-insured with respect to product liability and environmental claims and fully self-insured with respect to intellectual property infringement claims.
We continue to experience pressures across many of our businesses due to competitive activity, increased market power of our customers as the health care industry consolidates, national and regional government tenders, economic pressures experienced by our customers, staffing shortages within health care facilities that have and may continue to negatively impact demand for our products, public perception of our products, and the impact of managed care organizations and other third-party payers.
We continue to experience pressures across many of our businesses due to competitive activity, increased market power of our customers as the health care industry consolidates, national and regional government tenders, economic pressures experienced by our customers, capacity shortages within health care facilities that have and may continue to negatively impact demand for our products, public perception of our products, and the impact of managed care organizations and other third-party payers.
Global businesses, including those in the medical device industry, are facing increasing scrutiny of, and heightened enforcement efforts with respect to, their international operations.
Global businesses, including those in the medical device industry, are facing increasing scrutiny of, and heightened enforcement efforts with respect to, their 15 international operations.
Where renewal or 26 recertification applications are required, they may need to be renewed and/or approved in order to continue selling our products in those countries.
Where renewal or recertification applications are required, they may need to be renewed and/or approved in order to continue selling our products in those countries.
If we fail to obtain a required license or are unable to design around a patent, our business, financial condition or results of operations could be materially adversely affected. Pending and future product liability claims and other litigation, including private securities litigation, stockholder derivative suits and contract litigation, may adversely affect our financial condition and results of operations or liquidity.
If we fail to obtain a required license or are unable to design around a patent, our business, financial condition or results of operations could be materially adversely affected. 25 Pending and future product liability claims and other litigation, including private securities litigation, stockholder derivative suits, contract litigation, and environmental litigation may adversely affect our financial condition and results of operations or liquidity.
Further legislative or administrative reforms to the reimbursement systems in the U.S., Japan, China, or other countries in a manner that significantly reduce or eliminate reimbursement for procedures using our medical devices, including price regulation, site of service requirements, competitive bidding and tendering, coverage and payment policies, comparative effectiveness of therapies, heightened clinical data requirements, technology assessments and managed-care arrangements, could have a material adverse effect on our business, financial condition or results of operations.
These and any other legislative or administrative reforms to the reimbursement systems in the U.S., Japan, China, or other countries in a manner that significantly reduce or eliminate reimbursement for procedures using our medical devices, including price regulation, site of service requirements, competitive bidding and tendering, coverage and payment policies, comparative effectiveness of therapies, heightened clinical data requirements, technology assessments and managed-care arrangements, could have a material adverse effect on our business, financial condition or results of operations.
Continued inflationary pressure may also increase certain operational costs, including due to wage increases, or increases in the cost of materials or components.
Continued inflationary pressure may also increase certain operational costs, including due to 14 wage increases, or increases in the cost of materials or components.
If we, or our manufacturers, fail to adhere to quality system regulations or ISO requirements, this could delay production of our products and lead to fines, difficulties in obtaining regulatory clearances, recalls, enforcement actions, including injunctive relief or consent decrees, or other consequences, which could, in turn, have a material adverse effect on our financial condition or results of operations. 31 ITEM 1B.
If we, or our manufacturers, fail to adhere to quality system regulations or ISO requirements, this could delay production of our products and lead to fines, difficulties in obtaining regulatory clearances, recalls, enforcement actions, including injunctive relief or consent decrees, or other consequences, which could, in turn, have a material adverse effect on our financial condition or results of operations.
Economic, Industry and Geopolitical Risks We face intense competition and may not be able to keep pace with the rapid technological changes in the medical devices industry, which could have an adverse effect on our business, financial condition or results of operations. The medical device markets in which we participate are highly competitive.
Economic, Industry and Geopolitical Risks We face intense competition and may not be able to keep pace with the rapid technological changes in the medical devices industry or low-cost competitive offerings, which could have an adverse effect on our business, financial condition or results of operations. The medical device markets in which we participate are highly competitive.
As a result, we may experience loss of market share, which we may be unable to recapture and harm to our reputation, which could adversely affect our results of operations and financial condition. 23 Disruptions in the supply of the materials and components used in manufacturing our products by third-party vendors or the sterilization of our products could adversely affect our results of operations and financial condition.
As a result, we may experience loss of market share, which we may be unable to recapture and harm to our reputation, which could adversely affect our results of operations and financial condition. 18 Disruptions in the supply of the materials and components used in manufacturing our products by third-party vendors or the sterilization of our products could adversely affect our business, results of operations and financial condition.
International sales of medical devices manufactured in the U.S. that are not approved by the FDA for use in the U.S., or that are banned or deviate from lawful performance standards, are subject to FDA export requirements. Regulations regarding the development, manufacture and sale of medical devices are evolving and subject to future change.
International sales of medical devices manufactured in the U.S. that are not approved by the FDA for use in the U.S., or that are banned or deviate from lawful performance standards, are subject to FDA export requirements. Regulations regarding the development, manufacture and sale of medical devices continue to evolve and are subject to future change.
We also face competition from non-medical device companies, including pharmaceutical companies, biotech companies and providers of various diagnostic tests, which may offer alternative therapies or diagnostics for disease states also amenable to treatment or diagnosis using our products.
We also face competition from non-medical device companies, including pharmaceutical companies, biotech companies and providers of various diagnostic solutions, which may offer alternative therapies for disease states also amenable to diagnosis or treatment using our products.
We have also faced and may continue to face disruptions in the transportation of materials, components and our products within our global supply chains, including as a result of labor disputes or shortages, strikes, port closures, public health crises or geopolitical developments, which may cause delays in the shipment of our products or other disruptions to our business.
We have also faced and may continue to face disruptions in the transportation of materials, components and our products within our global supply chains, including as a result of labor disputes or shortages, strikes, port closures, public health crises or geopolitical developments, which may cause delays in the shipment of our products or other disruptions to our business, as well as increased freight costs.
In addition, the medical device markets in which we participate are characterized by extensive research and development and rapid technological change. Developments by other companies of products and/or services, processes or technologies may make our products or proposed products obsolete or less competitive and may negatively impact our net sales.
In addition, the medical device markets in which we participate are characterized by extensive research and development and rapid technological change. Developments by other companies of products and/or services, processes or technologies, including low-cost alternatives, may make our products or proposed products obsolete or less competitive and may negatively impact our net sales.
ITEM 1A. RISK FACTORS In addition to the other information contained in this Annual Report on Form 10-K and the exhibits hereto, the following risk factors should be considered carefully in evaluating our business. Our business, financial condition, cash flows or results of operations could be materially adversely affected by any of these risks. This section contains forward-looking statements.
ITEM 1A. RISK FACTORS In addition to the other information contained in this Annual Report on Form 10-K (this Annual Report) and the exhibits hereto, the following risk factors should be considered carefully in evaluating our business. Our business, financial condition, cash flows or results of operations could be materially adversely affected by any of these risks.
Moreover, the standards by which corporate social responsibility and sustainability efforts and related matters are measured are developing and evolving, and certain areas are subject to assumptions that could change over time. In addition, we could be criticized for the scope of such initiatives or goals or perceived as not acting responsibly in connection with these matters.
Moreover, the standards by which corporate social responsibility and sustainability efforts and related matters are measured continue to develop and evolve, and certain areas are subject to assumptions that could change over time. In addition, we could be criticized for the scope of such initiatives or goals or perceived as not acting responsibly in connection with these matters.
We are currently the subject of product liability litigation proceedings and other proceedings described in more detail under Note I – Commitments and Contingencies to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K . The outcome of litigation, particularly class action lawsuits, is difficult to assess or quantify.
We are currently the subject of product liability litigation proceedings and other proceedings described in more detail under Note I – Commitments and Contingencies to our consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report . The outcome of litigation, particularly class action lawsuits, is difficult to assess or quantify.
If we are unable to develop and launch new products and enhanced products, our ability to maintain or expand our market position in the markets in which we participate may be materially adversely impacted.
If we are unable to develop, obtain regulatory approval for and launch new products and enhanced products, our ability to maintain or expand our market position in the markets in which we participate may be materially adversely impacted.
Additionally, a growing number of countries have instituted or are contemplating introducing regional or national tender processes driven primarily by price. In some cases, such processes may favor local companies to multinational companies like us.
Additionally, a growing number of countries have instituted or are contemplating introducing regional or national tender processes driven primarily by price. In some cases, these or other local procurement processes may favor local players to multinational companies like us.
Any alleged or actual failure to comply with legal and regulatory requirements may subject us to government scrutiny, civil and/or criminal proceedings, sanctions and other liabilities, which may have a material adverse effect on our international operations, financial condition, results of operations and/or liquidity.
Any alleged or actual failure to comply with legal and regulatory requirements may subject us to government scrutiny, civil and/or criminal proceedings, sanctions, fines and penalties, or reputational harm which may have a material adverse effect on our international operations, financial condition, results of operations and/or liquidity.
You should refer to the explanation of the qualifications and limitations on forward-looking statements set forth at the end of Item 1. Business of this Annual Report on Form 10-K. The considerations and risks that follow are organized within relevant headings but may be relevant to other headings as well.
This section contains forward-looking statements. You should refer to the explanation of the qualifications and limitations on forward-looking statements set forth at the end of Part I, Item 1. Business of this Annual Report. The considerations and risks that follow are organized within relevant headings but may be relevant to other headings as well.
Interruption of our supply chain or manufacturing operations, including resulting from natural disasters, public health crises, geopolitical developments or other events outside of our control, could adversely affect our results of operations and financial condition. Our products are designed and manufactured in technology centers around the world, either by us or third parties.
Interruption of our supply chain or manufacturing operations, including resulting from natural disasters, public health crises, geopolitical developments or other events outside of our control, could have an adverse effect on our business, results of operations and financial condition. Our products are designed and manufactured in technology centers around the world, either by us or third parties.
Any such matters, or related corporate social responsibility and sustainability matters, could have a material adverse impact on our future results of operations, financial condition and cash flows. If we are unable to attract or retain key talent, it could have an adverse effect on our business, financial condition and results of operations.
Any such corporate social responsibility, sustainability or other similar matters could have a material adverse impact on our business and results of operations. 20 If we are unable to attract or retain key talent, it could have an adverse effect on our business, financial condition and results of operations.
The medical devices we design, develop, manufacture and market are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities. These authorities continue to closely scrutinize our industry.
The medical devices we design, develop, manufacture and market are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities. These authorities continue to closely scrutinize our industry, including for compliance with the U.S.
The 2023 Restructuring Plan is expected to result in total pre-tax charges of approximately $450 million to $550 million and reduce gross annual pre-tax expenses by approximately $225 million to $275 million as program benefits are realized. We expect a substantial portion of the savings to be reinvested in strategic growth initiatives.
The 2023 Restructuring Plan is expected to result in total pre-tax charges of approximately $700 million to $800 million and reduce gross annual pre-tax expenses by approximately $350 million to $400 million as program benefits are realized. We expect a substantial portion of the savings to be reinvested in strategic growth initiatives.
The fact that we do not maintain third-party insurance coverage for all categories of losses increases our exposure to unanticipated claims 30 and adverse decisions and these losses could have a material adverse effect on our financial condition, results of operations or liquidity.
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. 26 ITEM 1B. UNRESOLVED STAFF COMMENTS None.
In particular, the U.S.-China relationship may continue to shape the geopolitical stage. Legislation aimed at boosting 20 competitiveness of U.S. businesses may have unintended negative effects on our business. We may also face greater competition in China, among other countries, from domestic medical device companies that may benefit from their status as local manufacturers and suppliers.
Legislation aimed at boosting competitiveness of U.S. businesses may have unintended negative effects on our business. We may also face greater competition in China, among other countries, from domestic medical device companies that may benefit from their status as local manufacturers and suppliers.
As a result of these assessments, we have undertaken prior restructuring and optimization initiatives to enhance our growth potential and position us for long-term success.
As a result of these assessments, we have undertaken prior restructuring and optimization initiatives to enhance our growth potential and position us for long-term success, and may undertake other restructuring and optimization initiatives in the future.
We are subject to a number of market, business, financial, legal and regulatory risks and uncertainties with respect to our international operations that could have a material impact on our business, financial condition or results of operations. International net sales accounted for 39 percent of our global net sales in 2024.
We are subject to a number of market, business, financial, legal and regulatory risks and uncertainties with respect to our international operations that could adversely impact our business, financial condition or results of operations. International net sales accounted for 36 percent of our global net sales in 2025.
The process of obtaining marketing approval or clearance from the FDA or by comparable agencies in foreign countries for new products, or with respect to enhancements or modifications to existing products, could: • take a significant period of time, • require the expenditure of substantial resources, • involve rigorous pre-clinical and clinical testing, as well as increased post-market surveillance, • require changes to products, and • result in limitations on the indicated uses of products.
The process of obtaining marketing approval or clearance from the FDA or by comparable agencies in foreign countries for new products, or with respect to enhancements or modifications to existing products, could: • take a significant period of time, • require the expenditure of substantial resources, • involve rigorous pre-clinical and clinical testing, as well as increased post-market surveillance, • require changes to products, and • result in limitations on the indicated uses of products. 21 In addition, exported devices are subject to the regulatory requirements of each country to which the device is exported.
As part of our strategy to maximize stockholder value, we use financial leverage to manage our cost of capital. Our outstanding debt balance was $10.746 billion as of December 31, 2024.
As part of our strategy to maximize stockholder value, we use financial leverage to manage our cost of capital. Our outstanding debt balance was $11.436 billion as of December 31, 2025.
These changes could have an adverse impact on our ability to manufacture or supply certain products in a timely or cost effective manner or at all. These and other environmental laws and regulations may have additional impacts on us or our suppliers, or result in liability to us.
These changes could have an adverse impact on our ability to manufacture or supply certain products in a timely or cost-effective manner or at all. These and other environmental laws and regulations may have additional impacts on us or our suppliers, or result in fines and penalties or litigation against us, which could adversely affect our financial condition.
Challenging domestic and international economic conditions could adversely affect our business, financial condition, cash flows and results of operations. The global macroeconomic environment has continued to experience challenging conditions and uncertainty, including around inflation, interest rates, monetary policy, exchange rates and geopolitical developments, which could adversely impact our business, financial condition, cash flows and results of operations.
The global macroeconomic environment has continued to experience challenging conditions and uncertainty, including with respect to inflation, interest rates, monetary policy, exchange rates, tariff and trade policies and geopolitical developments, which could adversely impact our business, financial condition, cash flows and results of operations.
Unexpected or inconsistent clinical data from existing or future clinical trials or other analyses conducted by us, by our competitors or by third parties, including acquired businesses prior to acquisition by us, or the FDA's or the market's perception of this clinical data, may adversely impact our ability to obtain product approvals, our position in, and share of, the markets in which we participate and our business, financial condition, results of operations or future prospects.
Unexpected or inconsistent clinical data from existing or future clinical trials or other analyses conducted by us, by our competitors or by third parties, including acquired businesses prior to acquisition by us, or the FDA's or the market's perception of this clinical data, may adversely impact our ability to obtain product approvals, our position in, and share of, the markets in which we participate and our business, financial condition, results of operations or future prospects. 22 Any failure to meet regulatory quality standards applicable to our manufacturing and quality processes could have an adverse effect on our business, financial condition and results of operations.
Relatively small declines in the future performance and cash flows of a reporting unit or asset group, changes in our reporting units or in the structure of our business as a result of future reorganizations, acquisitions or divestitures of assets or businesses, or small changes in other key assumptions, may result in the recognition of significant asset impairment charges, which could have a material adverse impact on our results of operations.
Declines in the future performance and cash flows of a reporting unit or asset group, changes in our reporting units or in the structure of our business as a result of future reorganizations, acquisitions or divestitures of assets or businesses, or small changes in other key assumptions, may result in the recognition of significant asset impairment charges, which could have a material adverse impact on our results of operations. 16 Business and Operational Risks Failure to integrate acquired businesses into our operations successfully could adversely affect our business, financial condition and operating results.
Frequently, regulatory approval may first be obtained in a foreign country prior to application in the U.S. due to differing regulatory requirements; however, other countries, such as China for example, require approval in the country of origin or legal manufacturer first.
Some countries do not have medical device regulations, but in most countries, medical devices are regulated. Frequently, regulatory approval may first be obtained in a foreign country prior to application in the U.S. due to differing regulatory requirements; however, other countries, such as China for example, require approval in the country of origin or legal manufacturer first.
There may be greater uncertainty and market volatility following U.S. and global elections, including resulting from potential shifts in trade policies, tariffs or 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.
There continues to exist significant uncertainty regarding potential shifts in trade policies, tariffs and other trade protection measures, and the reaction of 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.
Continued consolidation in the health care industry or additional governmental controls exerted over pricing and access in key markets could lead to increased demands for price concessions or limit or eliminate our ability to sell to certain of our 18 significant market segments, which could have an adverse effect on our business, financial condition or results of operations.
Decreases in market sizes or our market share and declines in average selling prices or procedural volumes could materially adversely affect our results of operations or financial condition. 13 Continued consolidation in the health care industry or additional governmental controls exerted over pricing in and access to key markets could lead to increased demands for price concessions or limit or eliminate our ability to sell certain of our products, which could have an adverse effect on our business, financial condition or results of operations.
In recent years, there continues to be an increased focus from certain investors, customers, employees, regulators and other stakeholders globally concerning corporate social responsibility and sustainability matters. From time to time, we announce certain initiatives, including goals, regarding our focus areas, which include environmental matters, including carbon emissions and renewable energy goals, responsible sourcing, social investments and diversity and inclusion.
There continues to be an increased focus from certain investors, customers, employees, regulators and other stakeholders globally concerning corporate social responsibility and sustainability matters. From time to time, we announce certain initiatives and/or goals, including related to sustainability and environmental matters, including carbon emissions and renewable energy goals, employee engagement, responsible sourcing and social investments.
Intellectual property litigation is expensive, complex and lengthy and its outcome is difficult to predict. Adverse outcomes in one or more of these matters could have a material adverse effect on our ability to sell certain products and on our operating margins, financial condition, results of operation or liquidity.
Adverse outcomes in one or more of these matters could have a material adverse effect on our ability to sell certain products and on our operating margins, financial condition, results of operation or liquidity.
Our ability to attract and retain key talent at all levels of our organization has been and could continue to be challenged by these conditions, and inability to attract and retain talent could result in material adverse impacts to our business and results of operations.
A shortage of skilled labor could also require higher wages that would increase labor costs. Our ability to attract and retain key talent at all levels of our organization has been and could continue to be challenged by these conditions, and inability to attract and retain talent could result in material adverse impacts to our business and results of operations.
We may experience declines in market size, average selling prices for our products, medical procedure volumes and our share of the markets in which we compete, which may materially adversely affect our results of operations and financial condition.
We may experience declines in market size, average selling prices for our products, medical procedure volumes and/or our share of the markets in which we compete, which could have an adverse effect on our business, financial condition or results of operations.
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.
Any modification of existing tariffs, or the introduction of new U.S. tariffs under alternative authorities, on imports from the countries where we do business 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.
We have received and in the future may receive, subpoenas and other requests for information from Congress and state and federal governmental agencies, including, among others, the U.S. Department of Justice (DOJ), the Office of Inspector General of the 27 Department of Health and Human Services (HHS) and the Department of Defense, as well as from foreign governments and agencies.
We have received, and in the future may receive, subpoenas and other requests for information from Congress and state and federal governmental agencies, including, among others, the U.S. Department of Justice (DOJ), the U.S.
We are currently the subject of various patent litigation proceedings and other proceedings described in more detail under Note I – Commitments and Contingencies to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K .
We are currently the subject of various patent litigation proceedings and other proceedings described in more detail under Note I – Commitments and Contingencies to our consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report . Intellectual property litigation is expensive, complex and lengthy and its outcome is difficult to predict.
We also grow our company through acquisitions and may face risks associated with defects and vulnerabilities in acquired systems as we work to integrate the acquisitions into our IT system.
We also grow our company through acquisitions and may face risks associated with defects and vulnerabilities in acquired systems as we work to integrate the acquisitions into our IT system. We are subject to a wide range of global privacy, data‑protection, and cross‑border data‑transfer laws.
We may also face operational interruptions as we continue to implement our new global enterprise resource planning (ERP), which began in 2022. Malicious actors may attempt to trick staff to disclose information to gain access to our systems and/or data.
We have faced, and may continue to face, operational interruptions as we continue to implement our global enterprise resource planning (ERP) system. Malicious actors may attempt to trick staff to disclose information to gain access to our systems and/or data. International conflicts have also heightened cybersecurity risks on a global basis.
Further, other parties that hold remaining ownership interests in such businesses may at any time have economic or business goals that are inconsistent with our goals or the goals of such businesses.
In addition, we have and may in the future acquire less than full ownership interests in other businesses, which involve unique challenges for effective collaboration. Further, other parties that hold remaining ownership interests in such businesses may at any time have economic or business goals that are inconsistent with our goals or the goals of such businesses.
Accordingly, the final adoption, implementation, and interpretation of Pillar Two across all jurisdictions where we do business could have a material adverse impact on our financial condition, results of operations and cash flows. President Trump has indicated his willingness to increase the use of tariffs by the U.S. to accomplish certain U.S. policy goals.
Accordingly, the final adoption, implementation, and interpretation of Pillar Two across all jurisdictions where we do business could have a material adverse impact on our financial condition, results of operations and cash flows. We are subject to certain U.S. tariffs that are currently subject to legal challenge before the U.S. Supreme Court.
We cannot predict when a matter will be resolved, the outcome of the matter or its impact on us and cooperation may involve significant costs, including document production costs.
We have cooperated with these subpoenas and other requests for information and expect to continue to do so in the future. We cannot predict when a matter will be resolved, the outcome of the matter or its impact on us and cooperation may involve significant costs, including document production costs.
Under the FDC Act, medical devices must receive FDA clearance or approval or an exemption from such clearance or approval before they can be commercially marketed in the U.S. In the EU, we are required to comply with the Medical Device Regulation (MDR) effective May 2021, which superseded the Medical Device Directives.
Under the FDC Act, medical devices must receive FDA clearance or approval or an exemption from such clearance or approval before they can be commercially marketed in the U.S.
Foreign acquisitions involve unique risks, including those related to integration of operations across different geographies, cultures and languages, currency risks and risks associated with the economic, political, legal and regulatory environment in specific countries. In addition, we have and may in the future acquire less than full ownership interests in other businesses, which involve unique challenges for effective collaboration.
Foreign acquisitions involve unique risks, including those related to integration of operations across different geographies, cultures and languages, currency risks and risks associated with the economic, political, legal and regulatory environment in specific countries, including tax laws.
If we are unable to renew, extend, or obtain new incentives and grants, the expiration of the existing incentives and grants could have a material impact on our financial condition and results of operations in future periods. Many provisions of the Tax Cuts and Jobs Act (TCJA) enacted in the U.S. in 2017 expire at the end of 2025.
Unless these incentives and grants are extended, they will expire between 2028 and 2034. If we are unable to renew, extend, or obtain new incentives and grants, the expiration of the existing incentives and grants could have a material impact on our financial condition and results of operations in future periods.
While we continue to monitor legislative adoption of Pillar Two by country, as well as for additional guidance from the OECD, there is significant uncertainty that exists regarding the interpretation of the detailed Pillar Two rules, whether such rules will be implemented consistently across taxing jurisdictions, how such rules interact with existing national tax laws and whether such rules are consistent with existing tax treaty obligations.
However, Pillar Two remains enacted law and significant uncertainty exists regarding the implementation of the January 5th guidance as well as 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.
Notably the Russia/Ukraine war has continued to create barriers to doing business in Russia and in parts of Eastern Europe, tension between China/Taiwan has created geopolitical shifts in Asia, and conflicts in the Middle East have disrupted operations of companies doing business in the region, including in Israel.
Sanctions and export restrictions may continue to proliferate, leading to greater uncertainty in emerging and growth markets. Notably the Russia/Ukraine war has continued to create barriers to doing business in Russia and in parts of Eastern Europe and conflicts in the Middle East have disrupted operations of companies doing business in the region, including in Israel.
The 2023 Restructuring Plan further builds on our Global Supply Chain Optimization strategy, which is intended to simplify our manufacturing and distribution network by transferring certain production lines among facilities and expanding operational efficiencies and resiliency across production, sterilization, and distribution.
For example, in February 2023, we committed to a global restructuring program (the 2023 17 Restructuring Plan) intended to support our efforts to expand operating performance and meet evolving global market demands and conditions, and which built on our Global Supply Chain Optimization strategy to simplify our manufacturing and distribution network by transferring certain production lines among facilities and expanding operational efficiencies and resiliency across production, sterilization, and distribution.
Medical devices that have a valid CE Certificate to the Directives issued before May 2021 could be sold until the earlier of May 2024 or when the CE Certificate expired, provided there were no significant changes to the design or intended use.
Medical devices that have a valid CE Certificate issued before May 2021 can continue to be sold during the applicable transition period or until the CE Certificate expires, whichever comes first, provided there are no significant changes to the design or intended use.
The loss of one or more key employees, our ability to attract or develop additional qualified employees or any delay in hiring key personnel could have material adverse effects on our business, financial condition or results of operations. A shortage of skilled labor could also require higher wages that would increase labor costs.
There can be no assurance that we will be successful in retaining and developing existing personnel or recruiting new personnel. The loss of one or more key employees, our ability to attract or develop new or additional qualified employees or any delay in hiring key personnel could have material adverse effects on our business, financial condition or results of operations.
These potential consequences, as well as any adverse outcome from these requests or investigations, could have a material adverse effect on our financial condition, results of operations and liquidity.
We anticipate that governmental authorities will continue to scrutinize our industry closely and that additional regulation may increase compliance and legal cost or exposure to litigation. These potential consequences, as well as any adverse outcome from such requests or investigations, could have a material adverse effect on our financial condition, results of operations and liquidity.
In our industry, there is substantial competition for key personnel in the regions in which we operate and we may face increased competition for such employees.
In our industry, there is substantial competition for key personnel in the regions in which we operate and we may face increased competition for such employees. Our business depends to a significant extent on the continued service of senior management and other key personnel, the development of additional management personnel and the hiring of new qualified employees.
Our business and operations are subject to risks related to climate change. The effects of global climate change present risks to our business.
Our business and operations are subject to risks related to natural disasters, climate change and other extreme weather.
The actual outcomes of these disputes and other tax audits could have a material impact on our financial condition and results of operations. Our operations in Puerto Rico, Costa Rica, China and Malaysia presently benefit from various tax rate incentives and grants. Unless these incentives and grants are extended, they will expire between 2026 and 2034.
The actual outcomes of these disputes and other tax audits could have a material impact on our financial condition and results of operations. Our manufacturing facilities in Costa Rica operate under the Free Trade Zone regime, and we also benefit from tax holidays and tax incentive grants in various other countries.
Business and Operational Risks Failure to integrate acquired businesses into our operations successfully could adversely affect our business, financial condition and operating results. As part of our strategy to realign our business portfolio, we have completed multiple acquisitions in recent years and may pursue additional acquisitions in the future.
As part of our strategy to strengthen our core businesses and expand into high growth adjacencies, we have completed multiple acquisitions in recent years and may pursue additional acquisitions in the future.
Lastly, geopolitical developments related to various global conflicts are sources of uncertainty and may cause disruptions to global or regional markets, supply chains or operations in the regions. Sanctions and export restrictions may continue to proliferate, leading to greater uncertainty in emerging and growth markets.
Geopolitical developments related to 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 Russia/Ukraine war, tension in the Taiwan strait, and conflicts in the Middle East.
Key activities under the 2023 Restructuring Plan also include optimizing certain functional capabilities to better support business growth and achieve cost synergies. These activities were initiated during the first quarter of 2023, and are expected to be substantially completed by the end of 2025.
Key activities under the 2023 Restructuring Plan were initiated during the first quarter of 2023 and were substantially complete by the end of 2025.
International conflicts, including but not limited to the Russia/Ukraine war, conflicts in the Middle East, and tension between China/Taiwan, have also heightened cybersecurity risks on a global basis. If our incident response, disaster recovery, and business continuity plans fail, such failure could result in adverse impacts to our business operations and our financial results.
If our incident response, disaster recovery, and business continuity plans fail, such failure could result in adverse impacts to our business operations and our financial results.
The CE Mark is applied following approval from an independent notified body or declaration of conformity.
In 2023, the European Commission extended the transitional period to 2027 for certain high risk class devices and 2028 for lower risk class medical devices. The CE Mark is applied following approval from an independent notified body or declaration of conformity.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

15 edited+5 added−10 removed2 unchanged
Biggest changeOur cybersecurity program is designed to monitor and continually enhance our enterprise security posture, with the goal of preventing cybersecurity incidents to the extent feasible, including assessments to better understand our readiness for cybersecurity threats and the resilience of our critical business functions, with the goal of avoiding or reducing the impact if such an event were to occur.
Biggest changeOur cybersecurity program is designed to monitor and continually enhance our enterprise security posture, including assessments to evaluate readiness and resilience with the goal of preventing incidents and mitigating the impact in the event an incident occurs. We have implemented cybersecurity policies mapped to industry and government standards and frameworks, such as U.S.
Our current CISO has over 19 years of extensive information technology experience, including in security architecture, software development and engineering, as well as leading security operations and incident response, offensive and defensive cyber projects in increasing roles of responsibility. He also previously held Certified Information Systems Security Professional (CISSP) and GIAC Certified Forensics Analyst certifications.
Our current CISO has over 20 years of extensive information technology experience, including in security architecture, software development and engineering, as well as leading security operations and incident response, offensive and defensive cyber projects in increasing roles of responsibility. He also previously held Certified Information Systems Security Professional (CISSP) and GIAC Certified Forensics Analyst certifications.
Despite our security measures, however, there can be no assurance that we, or the third parties with which we interact, will not experience a cybersecurity incident in the future that may materially affect us. For additional information, see Item 1A.
Despite our security measures, however, there can be no assurance that we, or the third parties with which we interact, will not experience a cybersecurity incident in the future that may materially affect us. For additional information, see Part I, Item 1A.
Matters determined to present potential material impacts to our financial results, operations, and/or reputation are immediately reported by management to the Board of Directors, or individual members or committees thereof, as appropriate, in accordance with our established escalation framework.
Matters determined to present potential material impacts to our financial results, operations, and/or reputation are immediately reported by management to the Board, or individual members or committees thereof, as appropriate, in accordance with our established escalation framework.
We have established controls and procedures to escalate enterprise level issues, including cybersecurity matters, to the appropriate management levels within our organization and our Board of Directors, or members or committees thereof, as appropriate.
We have established controls and procedures to escalate enterprise level issues, including cybersecurity matters, to the appropriate management levels within our organization and the Board, or members or committees thereof, as appropriate.
Under our framework, cybersecurity issues, including those involving vulnerabilities introduced by our IT, OT systems and use of third-party software, are analyzed by subject matter experts, including a crisis committee as needed in accordance with our incident response plans, for potential financial, operational, and reputational risks, based on, among other factors, the nature of the matter and breadth of impact.
Under our framework, cybersecurity issues, including vulnerabilities introduced through our IT and OT systems, the use of artificial intelligence technologies, and risks arising from third-party software and service providers, are analyzed by subject matter experts, including a crisis committee as needed in accordance with our incident response plans, for potential financial, operational, and reputational risks, based on, among other factors, the nature of the matter and breadth of impact.
“Risk Factors” for a discussion of cybersecurity risks that we face. 32 Governance Our global cybersecurity organization is led by our chief information security officer (CISO), who reports directly to our chief information officer (CIO) and under the organization of our chief information and digital officer (CIDO).
“Risk Factors” for a discussion of cybersecurity risks that we face. 27 Governance Our global cybersecurity organization is led by our chief information security officer (CISO), under the organization of our chief information and digital officer (CIDO).
We have established an enterprise cybersecurity program, which is administered by a cross-functional team of cybersecurity professionals that includes employees and third party contractors and vendors, that utilizes various tools, methodologies and processes to assess, identify and manage cybersecurity risks related to our IT and OT systems, as well as our products.
ITEM 1C. CYBERSECURITY Risk Management and Strategy We have established an enterprise cybersecurity program, which is administered by a cross-functional team of cybersecurity professionals that includes employees and third party contractors and vendors, that utilizes various tools, methodologies and processes to assess, identify and manage cybersecurity risks related to our information technology (IT) and operational technology (OT) systems.
Our current CIDO has extensive experience overseeing information technology and security programs, including roles of increasing leadership within our Information and Digital organizations over the last ten years, and prior to that in increasing roles of responsibility managing information systems, including over 18 years at General Electric. Our current CIDO holds CISSP and other IT certifications.
Our current CIDO is a member of our executive committee and has extensive experience overseeing information technology and security programs, including roles of increasing leadership within our Information and Digital organizations over the last ten years, and prior to that in increasing roles of responsibility managing information systems, including over 18 years at General Electric.
We have implemented cybersecurity policies mapped to industry and government standards and frameworks, such as U.S. National Institute of Standards and Technology (NIST) and International Standard of Organization, and our strategy is aligned to the NIST CyberSecurity Framework that provides us a structured approach to managing our cybersecurity risk through its five core functions.
National Institute of Standards and Technology (NIST) and International Standard of Organization, and our strategy is aligned to the NIST CyberSecurity Framework that provides us a structured approach to managing our cybersecurity risk through its five core functions. We regularly review our cybersecurity policies and require annual cybersecurity training for our employees.
Cybersecurity related risks are included in the risk universe that the ERM function evaluates to assess top risks to the Company on an annual basis. Risks are discussed with appropriate members of management, who manage risk coverage, monitoring and reporting in the relevant risk function, including our cybersecurity program, and incorporate those activities as part of developing our strategic plan.
Risks are discussed with appropriate members of management, who oversee risk coverage, monitoring and reporting in the relevant risk function, including in our cybersecurity program, and incorporate those activities as part of developing our strategic plan.
Our Board of Directors oversees an enterprise-wide approach to risk management, including cybersecurity risks. While the Board has the ultimate responsibility for risk oversight, each committee of the Board also oversees risk to the extent it relates to the committee’s responsibilities and provides reports to the Board in its respective area of responsibility.
While the Board has ultimate responsibility for risk oversight, each committee of the Board also oversees risks to the extent they relate to the committee’s respective area of responsibility and provides reports to the Board as appropriate.
We use third party security providers for specialized areas such as incident response, penetration testing, and on-demand cybersecurity services, including staff augmentation and consulting. We also leverage a managed security service provider to augment our cybersecurity organization and to provide additional monitoring and response capabilities.
We engage third-party security partners for specialized services such as incident response, penetration testing, and on-demand cybersecurity support. We also use a managed security service provider to enhance our security operations center with AI-enabled monitoring, analysis, and threat correlation capabilities.
We regularly review our cybersecurity policies and require annual cybersecurity training for our employees. We also periodically conduct simulation exercises involving employees at various levels of the organization, as well as our Board of Directors, to prepare for cybersecurity incidents and response planning.
We also periodically conduct simulation exercises involving employees at various levels of the organization and provide annual cybersecurity briefings to our Board of Directors. Cybersecurity education has also been provided to our Board of Directors to support incident preparedness.
Our Board of Directors also receives annual updates on such cybersecurity matters, or more frequently as appropriate under the procedures described below. Our Board of Directors also receive cybersecurity risk assessments as part of the annual ERM program presentation described above.
The Board receives annual updates (or more frequently, as appropriate under the procedures described below) on cybersecurity matters, including our cybersecurity program, cybersecurity risks, and the evolving threat landscape. Separately, the Board receives cybersecurity risk updates through the ERM program's annual risk assessment presented to the Board.
Removed
ITEM 1C. CYBERSECURITY Risk Management and Strategy We rely on information technology (IT) and operational technology (OT) systems, including technology from third party vendors, to manufacture and ship our products, as well as to process, transmit and store electronic information in our day-to-day operations.
Added
We have an established product cybersecurity program that ensures cybersecurity risk management is incorporated into the entire lifecycle for all of our products.
Removed
Our product cybersecurity focus begins with our design protocols and is supported by quality testing, provider education, and packaging and distribution standards.
Added
Our product cybersecurity program applies various tools, methodologies and processes to each lifecycle stage and helps ensure that our products are designed, built, tested, deployed and maintained in accordance with medical device cybersecurity standards, best practices, and guidance documents. This serves to build appropriate cybersecurity controls into our medical device products while also meeting regulatory compliance objectives.
Removed
We use penetration testing to simulate cyberattacks and better understand our exploitable weaknesses, and we monitor threat intelligence feeds, including avenues for product users to report vulnerabilities directly to us, and use scanning tools to detect and assess vulnerabilities that could affect our products.
Added
All third parties undergo security due diligence and risk assessment prior to engagement, with additional reviews performed as needed based on risk. If a third party experiences a cybersecurity incident that could affect our business, we conduct a full assessment and implement appropriate safeguards. Our cybersecurity team also continually monitors third-party security posture to help mitigate risks to our systems.
Removed
In addition, we conduct product, enterprise and vendor/third party risk assessments, vulnerability assessments and analyses to gain insights into potential vulnerabilities and their impact on critical functions, and leverage their outcomes to prioritize our security investments and balance our resource allocation.
Added
Cybersecurity risks are also monitored within our enterprise risk management (ERM) program and included in the risk universe used to assess top risks to the Company on an annual basis.
Removed
We engage and rely upon third parties to provide services and/or goods, represent and/or otherwise act on our behalf.
Added
Our current CIDO holds CISSP and other IT certifications. Our Board of Directors (the Board) oversees an enterprise-wide approach to risk management, including cybersecurity risks.
Removed
Prior to engaging or conducting any business with or on our behalf, such parties undergo a due diligence review, and a third party security risk assessment is conducted to validate they are legally permitted and qualified to maintain appropriate safeguards to protect our information assets in connection with the services they intend to provide.
Removed
We perform supplemental reviews as necessary commensurate with the risk associated with each third party, for example, if or when a third party is affected by an incident, that directly or indirectly impacts our company we undertake a full assessment and implement additional controls commensurate to the risk.
Removed
Furthermore, to minimize risks and vulnerabilities to our systems, our cybersecurity team continuously monitors and addresses cybersecurity threats and incidents at third-party service providers. Assessing, identifying, and managing cybersecurity related risks are also integrated into our enterprise risk management (ERM) program.
Removed
The ERM program’s annual risk assessment is presented annually to our Board of Directors.
Removed
The Risk Committee of our Board also focuses on an enterprise-wide approach to risk management, and has primary oversight responsibility for areas of quality and nonfinancial compliance issues, including cybersecurity risks. The Risk Committee receives periodic updates from the CISO and CIDO on our cybersecurity risks and threats, assessments of our cybersecurity program and the evolving threat landscape.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe following is a summary of our facilities as of December 31, 2024 (in approximate square feet): Owned (1) Leased (2) Total U.S. 4,148,417 2,249,380 6,397,797 International 3,615,983 2,410,040 6,026,023 7,764,400 4,659,420 12,423,820 (1) Includes our principal manufacturing facilities in Minnesota, Ireland, Puerto Rico and Coyol, Costa Rica, our manufacturing facility in Malaysia, our primary customer fulfillment centers in Massachusetts, the Netherlands, Malaysia and Japan, as well as our global headquarters located in Marlborough, Massachusetts.
Biggest changeThe following is a summary of our facilities as of December 31, 2025 (in approximate square feet): Owned (1) Leased (2) Total U.S. 4,548,538 1,932,916 6,481,454 International 3,596,282 2,935,190 6,531,472 8,144,820 4,868,106 13,012,926 (1) Includes our principal manufacturing facilities in Minnesota, Ireland, Puerto Rico and Coyol, Costa Rica, our manufacturing facility in Malaysia, our primary customer fulfillment centers in Massachusetts, the Netherlands, Malaysia and Japan, as well as our global headquarters located in Marlborough, Massachusetts.
(2) Includes our principal manufacturing facilities in California, Indiana, Brazil, China and Heredia, Costa Rica, as well as our regional headquarters located in Singapore and Voisins-le-Bretonneux, France.
(2) Includes our principal manufacturing facilities in California, Indiana, China and Heredia, Costa Rica, as well as our regional headquarters located in Singapore and Voisins-le-Bretonneux, France.
As of December 31, 2024, we maintained 16 principal manufacturing facilities, including eight in the U.S. and Puerto Rico, three in Ireland, two in Costa Rica, one in Malaysia, one in Brazil, one in China, as well as a Global Headquarters in the U.S. and various distribution and technology centers around the world.
As of December 31, 2025, we maintained 13 principal manufacturing facilities, including six in the U.S. and Puerto Rico, three in Ireland, two in Costa Rica, one in Malaysia, one in China, as well as a Global Headquarters in the U.S. and various distribution and technology centers around the world.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

1 edited+0 added−0 removed0 unchanged
Biggest changeITEM 3. LEGAL PROCEEDINGS See Note I – Commitments and Contingencies to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K, which is incorporated herein by reference. 33 ITEM 4. MINE SAFETY DISCLOSURES Not Applicable. 34 PART II
Biggest changeITEM 3. LEGAL PROCEEDINGS See Note I – Commitments and Contingencies to our consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K, which is incorporated herein by reference. 28 ITEM 4. MINE SAFETY DISCLOSURES Not Applicable. 29 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

7 edited+1 added−0 removed1 unchanged
Biggest changeWe made no share repurchases in 2024 or 2023 and, as of December 31, 2024, had the full $1.000 billion remaining available under the 2020 Share Repurchase Program. Refer to Note J – Stockholders' Equity to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K for additional information.
Biggest changeWe made no share repurchases in 2025 or 2024 and, as of December 31, 2025, had the full $1.000 billion remaining available under the 2020 Share Repurchase Program. Refer to Note J – Stockholders' Equity to our consolidated financial statements included in Part II, Item 8.
Securities Authorized for Issuance under Equity Compensation Plans Please see Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters under Part III of this Annual Report on Form 10-K for information on where to find information required by Item 201(d) of Regulation S-K.
Securities Authorized for Issuance under Equity Compensation Plans Please see Part III, Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters of this Annual Report on Form 10-K for information on where to find information required by Item 201(d) of Regulation S-K.
Dividends We did not pay a cash dividend in 2024, 2023 or 2022 on our common stock and currently we do not intend to pay cash dividends on our common stock. We may consider declaring and paying a cash dividend in the future; however, there can be no assurance that we will do so.
Dividends We did not pay a cash dividend in 2025, 2024 or 2023 on our common stock and currently we do not intend to pay cash dividends on our common stock. We may consider declaring and paying a cash dividend in the future; however, there can be no assurance that we will do so.
The graph assumes $100 was invested in our common stock and in each of the named indices on December 31, 2019 and that any dividends were reinvested. Note: The stock price performance shown on the graph above is not indicative of future price performance.
The graph assumes $100 was invested in our common stock and in each of the named indices on December 31, 2020 and that any dividends were reinvested. Note: The stock price performance shown on the graph above is not indicative of future price performance.
There were no purchases of equity securities by the issuer or affiliated purchases in the fourth quarter of 2024, required to be reported here. 35 Stock Performance Graph The graph below compares the five-year total return to stockholders on our common stock with the return of the Standard & Poor’s (S&P) 500 Stock Index and the S&P Health Care Equipment Index.
There were no purchases of equity securities by the issuer or affiliated purchases in the fourth quarter of 2025, required to be reported here. 30 Stock Performance Graph The graph below compares the five-year total return to stockholders on our common stock with the return of the Standard & Poor’s (S&P) 500 Stock Index and the S&P Health Care Equipment Index.
This graph shall not be deemed "filed" for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing. 36 ITEM 6. RESERVED 37
This graph shall not be deemed "filed" for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing. 31 ITEM 6. RESERVED 32
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information The principal market on which our common stock is traded is the New York Stock Exchange (NYSE) under the symbol “BSX.” Holders of Record As of January 31, 2025 , there were 5,072 holders of record of our common stock.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information The principal market on which our common stock is traded is the New York Stock Exchange (NYSE) under the symbol “BSX.” Holders of Record As of January 30, 2026 , there were 4,570 holders of record of our common stock.
Added
Financial Statements and Supplementary Data of this Annual Report on Form 10-K for additional information.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

132 edited+41 added−68 removed72 unchanged
Biggest changeRefer to Results of Operations and Additional Information for a discussion of each reconciling item: Year Ended December 31, 2024 (in millions, except per share data) Income (Loss) Before Income Taxes Income Tax Expense (Benefit) Net Income (Loss) Preferred Stock Dividends Net Income (Loss) Attributable to Noncontrolling Interests Net Income (Loss) Attributable to Boston Scientific Common Stockholders Impact per Share Reported $ 2,282 $ 436 $ 1,846 $ — $ (8) $ 1,853 $ 1.25 Non-GAAP adjustments: Amortization expense 856 113 743 — 9 734 0.49 Goodwill and other intangible asset impairment charges 386 48 339 — — 339 0.23 Acquisition/divestiture-related net charges (credits) 403 28 375 — — 375 0.25 Restructuring and restructuring-related net charges (credits) 229 30 199 — — 199 0.13 Litigation-related net charges (credits) — 0 (0) — — (0) (0.00) Investment portfolio net losses (gains) and impairments 20 1 19 — — 19 0.01 European Union (EU) Medical device regulation (MDR) implementation costs 52 7 45 — — 45 0.03 Deferred tax expenses (benefits) — (165) 165 — — 165 0.11 Discrete tax items — 4 (4) — — (4) (0.00) Adjusted $ 4,229 $ 502 $ 3,726 $ — $ 1 $ 3,725 $ 2.51 Year Ended December 31, 2023 (in millions, except per share data) Income (Loss) Before Income Taxes Income Tax Expense (Benefit) Net Income (Loss) Preferred Stock Dividends Net Income (Loss) Attributable to Noncontrolling Interests Net Income (Loss) Attributable to Boston Scientific Common Stockholders Impact per Share (4) Reported $ 1,985 $ 393 $ 1,592 $ (23) $ (1) $ 1,570 $ 1.07 Non-GAAP adjustments: Amortization expense 828 115 713 — 4 709 0.48 Goodwill and other intangible asset impairment charges 58 4 54 — — 54 0.04 Acquisition/divestiture-related net charges (credits) 373 21 352 — — 352 0.24 Restructuring and restructuring-related net charges (credits) 185 29 156 — — 156 0.11 Litigation-related net charges (credits) (111) (23) (88) — — (88) (0.06) Investment portfolio net losses (gains) and impairments 21 (3) 24 — — 24 0.02 EU MDR implementation costs 69 10 59 — — 59 0.04 Deferred tax expenses (benefits) — (155) 155 — — 155 0.11 Discrete tax items — (8) 8 — — 8 0.01 Adjusted $ 3,407 $ 382 $ 3,025 $ (23) $ 4 $ 2,999 $ 2.05 (4) For 2023, the effect of assuming the conversion of our 5.50% Mandatory Convertible Preferred Stock, Series A (MCPS) into shares of common stock was anti-dilutive, and therefore excluded from the calculation of Net income (loss) per common share — diluted (EPS).
Biggest changeThe following is a reconciliation of our results of operations prepared in accordance with GAAP to those adjusted results considered by management: Year Ended December 31, 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 $ 3,385 $ 493 $ 2,892 $ (6) $ 2,898 $ 1.94 Non-GAAP adjustments: Amortization expense 897 127 770 9 761 0.51 Goodwill and other intangible asset impairment charges 46 8 37 — 37 0.02 Acquisition/divestiture-related net charges (credits) 245 59 186 — 186 0.12 Restructuring and restructuring-related net charges (credits) 343 46 298 — 298 0.20 Litigation-related net charges (credits) 194 45 149 — 149 0.10 Investment portfolio net losses (gains) and impairments 26 (0) 26 — 26 0.02 European Union (EU) Medical device regulation (MDR) implementation costs 46 6 39 — 39 0.03 Deferred tax expenses (benefits) — (206) 206 — 206 0.14 Discrete tax items — 27 (27) — (27) (0.02) Adjusted $ 5,182 $ 605 $ 4,577 $ 3 $ 4,574 $ 3.06 Year Ended December 31, 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 $ 2,282 $ 436 $ 1,846 $ (8) $ 1,853 $ 1.25 Non-GAAP adjustments: Amortization expense 856 113 743 9 734 0.49 Goodwill and other intangible asset impairment charges 386 48 339 — 339 0.23 Acquisition/divestiture-related net charges (credits) 403 28 375 — 375 0.25 Restructuring and restructuring-related net charges (credits) 229 30 199 — 199 0.13 Litigation-related net charges (credits) — 0 (0) — (0) (0.00) Investment portfolio net losses (gains) and impairments 20 1 19 — 19 0.01 EU MDR implementation costs 52 7 45 — 45 0.03 Deferred tax expenses (benefits) — (165) 165 — 165 0.11 Discrete tax items — 4 (4) — (4) (0.00) Adjusted $ 4,229 $ 502 $ 3,726 $ 1 $ 3,725 $ 2.51 51 Year Ended December 31, 2023 (in millions, except per share data) Income (Loss) Before Income Taxes Income Tax Expense (Benefit) Net Income (Loss) Preferred Stock Dividends Net Income (Loss) Attributable to Noncontrolling Interests Net Income (Loss) Attributable to Boston Scientific Common Stockholders Impact per Share (1) Reported $ 1,985 $ 393 $ 1,592 $ (23) $ (1) $ 1,570 $ 1.07 Non-GAAP adjustments: Amortization expense 828 115 713 — 4 709 0.48 Goodwill and other intangible asset impairment charges 58 4 54 — — 54 0.04 Acquisition/divestiture-related net charges (credits) 373 21 352 — — 352 0.24 Restructuring and restructuring-related net charges (credits) 185 29 156 — — 156 0.11 Litigation-related net charges (credits) (111) (23) (88) — — (88) (0.06) Investment portfolio net losses (gains) and impairments 21 (3) 24 — — 24 0.02 EU MDR implementation costs 69 10 59 — — 59 0.04 Deferred tax expenses (benefits) — (155) 155 — — 155 0.11 Discrete tax items — (8) 8 — — 8 0.01 Adjusted $ 3,407 $ 382 $ 3,025 $ (23) $ 4 $ 2,999 $ 2.05 (1) For 2023, the effect of assuming the conversion of our 5.50% Mandatory Convertible Preferred Stock, Series A (MCPS) into shares of common stock was anti-dilutive, and therefore excluded from the calculation of Net income (loss) per common share - diluted (EPS).
Accordingly, GAAP Net income (loss) and Adjusted net income were reduced by cumulative Preferred stock dividends , as presented in our consolidated statements of operations, for purposes of calculating GAAP Net income (loss) attributable to Boston Scientific common stockholders .
Accordingly, GAAP Net income (loss) and Adjusted net income were reduced by cumulative Preferred stock dividends , as presented in our consolidated statements of operations, for purposes of calculating GAAP Net income attributable to Boston Scientific common stockholders .
Investment impairment charges and fair value remeasurements can be highly variable dependent on external market factors and conditions 58 relative to the underlying investee, which are generally outside of the control of management, as such these amounts are excluded from management's assessment of performance, • Deferred tax expenses (benefits) - This adjustment relates to a significant non-cash tax benefit arising from an intra-entity asset transfer of intellectual property completed in the fourth quarter of 2019 which resulted in our recording a $4.102 billion net deferred tax asset.
Investment impairment charges and fair value remeasurements can be highly variable dependent on external market factors and conditions relative to the underlying investee, which are generally outside of the control of management, as such these amounts are excluded from management's assessment of performance, • Deferred tax expenses (benefits) - This adjustment relates to a significant non-cash tax benefit arising from an intra-entity asset transfer of intellectual property completed in the fourth quarter of 2019 which resulted in our recording a $4.102 billion net deferred tax asset.
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. The following is an explanation of each of the adjustments that management excluded as part of these non-GAAP financial measures as well as reasons for excluding each of these individual items.
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. 48 The following is an explanation of each of the adjustments that management excluded as part of these non-GAAP financial measures as well as reasons for excluding each of these individual items.
Restructuring initiatives 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 initiatives typically result in duplicative cost and exit costs over the defined timeframe and are not considered part of our core, ongoing operations.
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, any cash litigation 48 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 do not exceed $1.000 billion plus all accrued legal liabilities as of December 31, 2022.
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 do not exceed $1.000 billion plus all accrued legal liabilities as of December 31, 2022.
To calculate organic net sales growth rates, we also remove the impact of 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.
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.
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, • Litigation-related net charges (credits) - These adjustments include certain product liability and other litigation-related charges and credits.
Restructuring and restructuring- 49 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, • Litigation-related net charges (credits) - These adjustments include certain product liability and other litigation-related charges and credits.
Integration, separation and exit costs include contract cancellations, severance and other compensation-related charges and costs, 57 project management fees and costs, and other direct costs associated with the integration of our acquisitions or separation of our divested businesses.
Integration, separation and exit costs include contract cancellations, severance and other compensation-related charges and costs, project management fees and costs, and other direct costs associated with the integration of our acquisitions or separation of our divested businesses.
To calculate adjusted net income (loss), adjusted net income (loss) attributable to common stockholders and adjusted net income (loss) per share we exclude certain charges (credits) from GAAP net income and GAAP net income attributable to 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.
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.
Goodwill Valuation We allocate any excess purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination to goodwill.
We allocate any excess purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination to goodwill.
We believe that presenting adjusted net income (loss), adjusted net income (loss) attributable to common stockholders adjusted net income (loss) per share, operational 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 believe that presenting adjusted net income (loss), adjusted net income (loss) attributable to Boston Scientific common stockholders, adjusted net income (loss) per share, operational 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 assess goodwill for impairment at the reporting unit level, which is defined as an operating segment or one level below an operating segment, referred to as a component. For our 2024 annual impairment assessment, we identified the following reporting units for purposes of our annual goodwill impairment test: Interventional Cardiology, Rhythm Management, Peripheral Interventions, Endoscopy, Urology and Neuromodulation.
We assess goodwill for impairment at the reporting unit level, which is defined as an operating segment or one level below an operating segment, referred to as a component. For our 2025 annual impairment assessment, we identified the following reporting units for purposes of our annual goodwill impairment test: Interventional Cardiology, Rhythm Management, Peripheral Interventions, Endoscopy, Urology and Neuromodulation.
In making this assessment, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control–Integrated Framework (2013 framework). Based on our assessment, we believe that, as of December 31, 2024, our internal control over financial reporting is effective at a reasonable assurance level based on these criteria.
In making this assessment, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control–Integrated Framework (2013 framework). Based on our assessment, we believe that, as of December 31, 2025, our internal control over financial reporting is effective at a reasonable assurance level based on these criteria.
The table above does not include: • Any future obligations to make payments of contingent consideration pursuant to certain of our acquisition agreements, due to the exact amount and timing of payments being uncertain. Refer to Note B – Acquisitions and Strategic Investments to our consolidated financial statements included in Item 8.
The table above does not include: • Any future obligations to make payments of contingent consideration pursuant to certain of our acquisition agreements, due to the exact amount and timing of payments being uncertain. Refer to Note B – Acquisitions and Strategic Investments to our consolidated financial statements included in Part II, Item 8.
The terminal 54 value growth rate reflects our best estimates for stable, perpetual growth of our reporting units. We use estimates of market-participant risk-adjusted weighted average cost of capital as a basis for determining the discount rates to apply to our reporting units’ future expected cash flows.
The terminal value growth rate reflects our best estimates for stable, perpetual growth of our reporting units. We use estimates of market- 46 participant risk-adjusted weighted average cost of capital as a basis for determining the discount rates to apply to our reporting units’ future expected cash flows.
We designed our internal control process to provide reasonable assurance to management and the Board of Directors regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. We assessed the effectiveness of our internal control over financial reporting as of December 31, 2024.
We designed our internal control process to provide reasonable assurance to management and the Board of Directors regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. We assessed the effectiveness of our internal control over financial reporting as of December 31, 2025.
We record these charges and credits, which we consider to be unusual or infrequent and significant, within the litigation-related charges (credits) line in our consolidated statements of operations; all other legal and product liability charges, credits and costs are recorded within selling, general and administrative expenses.
We record these charges and credits, which we consider to be unusual or infrequent and significant, within the litigation-related charges (credits) line in our consolidated statements of operations; all other legal charges, credits and costs are recorded within selling, general and administrative expenses.
For a full understanding of our financial condition and results of operations, this discussion should be read in conjunction with our consolidated financial statements and accompanying notes included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K.
For a full understanding of our financial condition and results of operations, this discussion should be read in conjunction with our consolidated financial statements and accompanying notes included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K (this Annual Report).
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis provides information management believes to be relevant to understanding the financial condition and results of operations of Boston Scientific Corporation and its subsidiaries for the years ended December 31, 2024 and 2023.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis provides information management believes to be relevant to understanding the financial condition and results of operations of Boston Scientific Corporation and its subsidiaries for the years ended December 31, 2025 and 2024.
We accrue anticipated costs of settlement, damages, losses for product liability claims and, under certain conditions, costs of defense, based on historical experience or to the extent specific losses are probable and estimable. Otherwise, we expense these costs as incurred.
We accrue anticipated costs of settlement, damages, losses for claims and, under certain conditions, costs of defense, based on historical experience or to the extent specific losses are probable and estimable. Otherwise, we expense these costs as incurred.
The following are areas considered to be critical and require management’s judgment: Revenue Recognition, Inventory Provisions, Valuation of Intangible Assets and Contingent Consideration Liabilities, Goodwill Valuation, Legal and Product Liability Accruals and Income Taxes. 52 See Note A – Significant Accounting Policies to our consolidated financial statements included in Item 8.
The following are areas considered to be critical and require management’s judgment: Revenue Recognition, Inventory Provisions, Valuation of Intangible Assets and Contingent Consideration Liabilities, Goodwill Valuation, Legal and Product Liability Accruals and Income Taxes. See Note A – Significant Accounting Policies to our consolidated financial statements included in Part II, Item 8.
GAAP, these obligations relate primarily to expenses associated with future periods and, with the exception of accrued interest, are not reflected in our consolidated balance sheet as of December 31, 2024.
GAAP, these obligations relate primarily to expenses associated with future periods and, with the exception of accrued interest, are not reflected in our consolidated balance sheet as of December 31, 2025.
In our opinion, Boston Scientific Corporation and subsidiaries (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on the COSO criteria.
In our opinion, Boston Scientific Corporation and subsidiaries (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria.
To recognize an uncertain tax benefit in the consolidated financial statements, the taxpayer must determine if it is more likely than not that the position will be sustained, with the measurement of the resulting benefit calculated as the largest amount more than 50 percent likely to be realized upon resolution of the benefit.
To recognize an uncertain tax benefit in the consolidated financial statements, the taxpayer must determine if it is more likely than not that the position will be sustained, with the measurement of the resulting benefit calculated as the largest amount more than 50 percent likely to be realized upon resolution of the audit by the tax authorities.
Financial Statements and Supplementary Data of this Annual Report on Form 10-K for additional details on our tax rate. 46 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.
Financial Statements and Supplementary Data of this Annual Report for additional details on our tax rate. 40 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.
(4) Timing of payment for our long-term liability for legal matters that are probable and estimable as of December 31, 2024 is uncertain and as such it is excluded from the table above. Refer to Note I – Commitments and Contingencies to our consolidated financial statements included in Item 8.
(4) Timing of payment for our long-term liability for legal matters that are probable and estimable as of December 31, 2025 is uncertain and as such it is excluded from the table above. Refer to Note I – Commitments and Contingencies to our consolidated financial statements included in Part II, Item 8.
This does not include unamortized debt issuance discounts, deferred financing costs and gains on fair value hedges or finance lease obligations. Refer to Note E – Contractual Obligations and Commitments to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K for additional information. (2) In accordance with U.S.
This does not include unamortized debt issuance discounts, deferred financing costs and gains on fair value hedges or finance lease obligations. Refer to Note E – Contractual Obligations and Commitments to our consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report for additional information. (2) In accordance with U.S.
Financial Covenant As of December 31, 2024, we were in compliance with the financial covenant required by the 2021 Revolving Credit Facility.
Financial Covenant As of December 31, 2025, we were in compliance with the financial covenant required by the 2021 Revolving Credit Facility.
Financial Statements and Supplementary Data of this Annual Report on Form 10-K for more information. The amounts in the table above with respect to purchase obligations relate primarily to non-cancellable inventory commitments and capital expenditures entered in the normal course of business.
Financial Statements and Supplementary Data of this Annual Report for more information. The amounts in the table above with respect to purchase obligations relate primarily to non-cancellable inventory commitments and capital expenditures entered in the normal course of business.
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 December 31, 2024.
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 at that time.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the 2024 consolidated financial statements of the Company and our report dated February 18, 2025 expressed an unqualified opinion thereon.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the 2025 consolidated financial statements of the Company and our report dated February 17, 2026 expressed an unqualified opinion thereon.
(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.
(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, impairment of right of use lease assets, accelerated depreciation and fixed asset write-offs.
For additional information on our financial condition and results of operations for the year ended December 31, 2022, refer to Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our previously filed Annual Report on Form 10-K.
For additional information on our financial condition and results of operations for the year ended December 31, 2023, refer to Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our previously filed Annual Report on Form 10-K.
Financial Statements and Supplementary Data of this Annual Report on Form 10-K for more information; • Unrecognized tax benefits, accrued interest and penalties and other related items because the timing of their future cash settlement is uncertain. Refer to Note H – Income Taxes to our consolidated financial statements included in Item 8.
Financial Statements and Supplementary Data of this Annual Report for more information; • Unrecognized tax benefits, accrued interest and penalties and other related items because the timing of their future cash settlement is uncertain. Refer to Note H – Income Taxes to our consolidated financial statements included in Part II, Item 8.
Interest income increased during 2024, compared to prior periods, primarily due to higher average cash balances invested in each period as a result of the registered public offering of the 2024 Eurobonds during the first quarter of 2024.
Interest income increased during 2024, compared to prior periods, primarily due to higher average cash balances invested as a result of our registered public offering of the 2024 Eurobonds during the first quarter of 2024.
Other, net The following are the components of Other, net : Year Ended December 31, (in millions) 2024 2023 2022 Interest income $ 107 $ 22 $ 10 Net foreign currency gain (loss) (16) (41) (31) Net gains (losses) on investments (1) (79) (59) (1) Other income (expense), net (29) (14) (16) $ (16) $ (93) $ (38) (1) Net gains (losses) on investments include investment portfolio net losses (gains) and impairments as well as the impact of recording our share of the earnings or losses of equity method investees.
Other, net The following are the components of Other, net : Year Ended December 31, (in millions) 2025 2024 2023 Interest income $ 29 $ 107 $ 22 Net foreign currency gain (loss) (12) (16) (41) Net gains (losses) on investments (1) 139 (79) (59) Other income (expense), net (35) (29) (14) $ 121 $ (16) $ (93) (1) Net gains (losses) on investments include investment portfolio net losses (gains) and impairments as well as the impact of recording our share of the earnings or losses of equity method investees.
Brennan President and Chief Executive Officer Executive Vice President and Chief Financial Officer 60 Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Boston Scientific Corporation Opinion on Internal Control Over Financial Reporting We have audited Boston Scientific Corporation and subsidiaries’ internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
Mahoney Jonathan Monson President and Chief Executive Officer Executive Vice President and Chief Financial Officer 53 Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Boston Scientific Corporation Opinion on Internal Control Over Financial Reporting We have audited Boston Scientific Corporation and subsidiaries’ internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
Our liquidity plans are subject to a number of risks and uncertainties, including those described in Item 1A. Risk Factors of this Annual Report on Form 10-K, some of which are outside our control. These and other risks and uncertainties could limit our ability to successfully execute our business plans and adversely affect our liquidity plans.
Our liquidity plans are subject to a number of risks and uncertainties, including those described in Part I, Item 1A. Risk Factors of this Annual Report, some of which are outside our control. These and other risks and uncertainties could limit our ability to successfully execute our business plans and adversely affect our liquidity plans.
Legal Matters For a discussion of our material legal proceedings, see Note I – Commitments and Contingencies to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K. Critical Accounting Policies and Estimates Our financial results are affected by the selection and application of accounting policies and methods.
Legal Matters For a discussion of our material legal proceedings, see Note I – Commitments and Contingencies to our consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report. 44 Critical Accounting Policies and Estimates Our financial results are affected by the selection and application of accounting policies and methods.
Uncertainty around inflationary pressures, interest rates, monetary policy, trade 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.
Continued uncertainty around inflationary pressures, interest rates, foreign currency fluctuations, global trade policies and changes in tax laws, as well as actions by governments in response thereto, could create economic challenges which could negatively impact our business and results of operations.
Interest payments included above are calculated based on rates and required fees applicable to our outstanding debt obligations as of December 31, 2024 described in Note E – Contractual Obligations and Commitments to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K.
Interest payments included above are calculated based on rates and required fees applicable to our outstanding debt obligations as of December 31, 2025 described in Note E – Contractual Obligations and Commitments to our consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report.
Financial Statements and Supplementary Data of this Annual Report on Form 10-K for additional information related to our accounting policies and our consideration of these critical accounting areas.
Financial Statements and Supplementary Data of this Annual Report for additional information related to our accounting policies and our consideration of these critical accounting areas.
For more information on our acquisitions, refer to Note B – Acquisitions and Strategic Investments to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K.
For more information on our acquisitions, refer to Note B – Acquisitions and Strategic Investments to our consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report.
While global supply chain disruptions continued to improve in 2024, 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.
Global supply chain conditions have continued to improve, however we have continued to experience, and may in the future 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.
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.
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.
Refer to Note I – Commitments and Contingencies to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K for additional discussion of our material legal proceedings.
Refer to Note I – Commitments and Contingencies to our consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report for additional discussion of our material legal proceedings.
Reconciliations of each of these non-GAAP financial measures to the corresponding GAAP financial measure are included under Executive Summary above.
Reconciliations of each of these non-GAAP financial measures to the corresponding GAAP financial measure are included below and under Executive Summary and Results of Operations above.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. 61 /s/ Ernst & Young LLP Boston, Massachusetts February 18, 2025 62
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. 54 /s/ Ernst & Young LLP Boston, Massachusetts February 17, 2026 55
Pursuant to the 2023 Restructuring Plan, we recorded the following restructuring and restructuring-related charges: Year Ended December 31, (in millions) 2024 2023 2022 Restructuring charges (1) $ 16 $ 69 $ 24 Restructuring-related charges (2) 212 115 86 (1) These charges are recorded in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 420, Exit or Disposal Cost Obligations.
Pursuant to the 2023 Restructuring Plan and the ACURATE discontinuation, we recorded the following restructuring and restructuring-related charges: Year Ended December 31, (in millions) 2025 2024 2023 Restructuring net charges (credits) (1) $ 101 $ 16 $ 69 Restructuring-related net charges (credits) (2) 242 212 115 (1) These charges are recorded in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 420, Exit or Disposal Cost Obligations.
As of December 31, 2024, we had $414 million of unrestricted Cash and cash equivalents on hand, including approximately $50 million held by Acotec, a less than wholly owned entity of which we acquired a majority stake investment during the first quarter of 2023.
As of December 31, 2025, we had $1.965 billion of unrestricted Cash and cash equivalents on hand, including approximately $57 million held by Acotec, a less than wholly owned entity of which we acquired a majority stake investment during the first quarter of 2023.
We began our EU MDR implementation efforts in late 2019 and have incurred cumulative expenses of $408 million through December 31, 2024, which are primarily being recorded within Cost of product sold . We expect to incur total expenses of approximately $450 million to $500 million over the transition period.
EU MDR Implementation Costs We began our EU MDR implementation efforts in late 2019 and have incurred cumulative expenses of $464 million through December 31, 2025, which are primarily being recorded within Cost of product sold . We expect to incur total expenses of approximately $475 million to $525 million over the transition period.
Financial Statements and Supplementary Data of this Annual Report on Form 10-K for more information; • A previously executed finance lease for additional office and warehouse space which commenced in December 2024. Total estimated undiscounted future lease payments are approximately $240 million. This lease has a noncancellable lease term of 25 years.
Financial Statements and Supplementary Data of this Annual Report for more information; • A previously executed finance lease for additional office and warehouse space which commenced in December 2024. Total estimated undiscounted future lease payments are approximately $233 million. This lease has a remaining noncancellable lease term of 24 years.
Organic net sales growth was primarily driven by our endoluminal surgery franchise, our single-use imaging franchise led by our EXALT™ Model D Single-Use Duodenoscope and our biliary franchise led by our AXIOS™ Stent and Delivery System.
In 2024, reported net sales growth was primarily driven by our 35 endoluminal surgery franchise, our imaging systems franchise led by our EXALT™ Model D Single-Use Duodenoscope and our biliary franchise led by our AXIOS™ Stent and Delivery System.
Operating Expenses 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 % Selling, General and Administrative (SG&A) Expenses In 2024, our SG&A expenses increased $794 million, or 15 percent compared to 2023 and were 70 basis points lower as a percentage of net sales.
Operating Expenses The following table provides a summary of our key operating expenses: Year Ended December 31, 2025 2024 2023 (in millions) $ % of Net Sales $ % of Net Sales $ % of Net Sales Selling, general and administrative expenses $ 6,887 34.3 % $ 5,984 35.7 % $ 5,190 36.4 % Research and development expenses 2,052 10.2 % 1,615 9.6 % 1,414 9.9 % Selling, General and Administrative (SG&A) Expenses In 2025, our SG&A expenses increased $903 million, or 15 percent compared to 2024 and were 140 basis points lower as a percentage of net sales.
Covenant Requirement as of December 31, 2024 Actual as of December 31, 2024 Maximum permitted leverage ratio (1) 4.75 times 2.26 times (1) Ratio of total debt to deemed consolidated EBITDA, as defined by the 2021 Revolving Credit Facility credit agreement.
Covenant Requirement as of December 31, 2025 Actual as of December 31, 2025 Maximum permitted leverage ratio (1) 4.50 times 1.92 times (1) Ratio of total debt to deemed consolidated EBITDA, as defined by the 2021 Revolving Credit Facility credit agreement.
Financial Statements and Supplementary Data of this Annual Report on Form 10-K for information regarding our debt obligations.
Financial Statements and Supplementary Data of this Annual Report for information regarding our debt obligations.
Debt The following table presents the current and long-term portions of our total debt: As of (in millions) December 31, 2024 December 31, 2023 Current debt obligations $ 1,778 $ 531 Long-term debt 8,968 $ 8,571 Total debt $ 10,746 $ 9,102 The following table presents the portions of our total debt that are comprised of fixed and variable rate debt instruments, which are presented on an amortized cost basis: As of (in millions) December 31, 2024 December 31, 2023 Fixed-rate debt instruments $ 10,507 $ 9,070 Variable rate debt instruments 239 32 Total debt $ 10,746 $ 9,102 For additional details related to our debt obligations, including our financial covenant requirements, refer to Note E – Contractual Obligations and Commitments to our consolidated financial statements included in Item 8.
Debt The following table presents the current and long-term portions of our total debt: As of December 31, (in millions) 2025 2024 Current debt obligations $ 299 $ 1,778 Long-term debt 11,137 8,968 Total debt $ 11,436 $ 10,746 The following table presents the portions of our total debt that are comprised of fixed and variable rate debt instruments, which are presented on an amortized cost basis: As of December 31, (in millions) 2025 2024 Fixed-rate debt instruments $ 11,393 $ 10,507 Variable rate debt instruments 43 239 Total debt $ 11,436 $ 10,746 For additional details related to our debt obligations, including our financial covenant requirements, refer to Note E – Contractual Obligations and Commitments to our consolidated financial statements included in Part II, Item 8.
Stock-based compensation expense related to our stock ownership plans was $266 million in 2024 and $233 million in 2023.
Stock-based compensation expense related to our stock ownership plans was $299 million in 2025 and $266 million in 2024.
Research and Development (R&D) Expenses We remain committed to advancing medical technologies and investing in meaningful research and development projects across our businesses. In 2024, our R&D expenses increased $201 million, or 14 percent compared to 2023, and were 30 basis points lower as a percentage of net sales.
Research and Development (R&D) Expenses We remain committed to advancing medical technologies and investing in meaningful R&D projects across our businesses. In 2025, our R&D expenses increased $436 million, or 27 percent compared to 2024, and were 60 basis points higher as a percentage of net sales.
Financial Statements and Supplementary Data of this Annual Report on Form 10-K. Equity In 2024, we received $230 million in proceeds from stock issuances related to our stock option and employee stock purchase plans, compared to $182 million in 2023.
Financial Statements and Supplementary Data of this Annual Report. Equity In 2025, we received $282 million in proceeds from stock issuances related to our stock option and employee stock purchase plans, compared to $230 million in 2024.
Additional Information Use of Non-GAAP Financial Measures To supplement our 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 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.
Financial Statements and Supplementary Data of this Annual Report for additional information on standards implemented during 2025 and standards to be implemented in future periods. 47 Additional Information Use of Non-GAAP Financial Measures To supplement our 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.
In 2024, 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 $230 million and net proceeds from the issuance of commercial paper of $187 million, partially offset by payments of contingent consideration previously established in purchase accounting of $131 million.
In 2024, cash provided by (used for) financing activities also included proceeds from issuances of shares of common stock pursuant to employee stock compensation and purchase plans of $230 million and net proceeds from the issuance of commercial paper of $187 million.
For these transactions, we defer recognition of revenue on the sale of the earlier generation product based upon an estimate of the amount of product to be returned when the next-generation products are shipped to the customer.
In addition, we may allow customers to return previously purchased products for next-generation product offerings. For these transactions, we defer recognition of revenue on the sale of the earlier generation product based upon an estimate of the amount of product to be returned when the next-generation products are shipped to the customer.
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.
As of December 31, 2025, the maximum permitted leverage ratio is 4.50 times. We believe that we have the ability to comply with the financial covenant for the next 12 months. 42 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.
As of December 31, 2024, we had $1.435 billion of the litigation exclusion remaining.
As of December 31, 2025, we had $1.160 billion of the litigation exclusion remaining.
In 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 and impairment charges as well as certain discrete tax benefits primarily related to stock-based compensation and changes in valuation allowance.
In 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 and impairment charges as well as certain discrete tax benefits primarily related to stock-based compensation and changes in valuation allowance. On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was signed into law.
Variable Consideration We generally allow our customers to return defective, damaged and, in certain cases, expired products for credit. We base our estimate for sales returns upon historical trends and record the amount as a reduction to revenue when we sell the initial product. In addition, we may allow customers to return previously purchased products for next-generation product offerings.
The use of alternative estimates could result in a different amount of revenue deferral. Variable Consideration We generally allow our customers to return defective, damaged and, in certain cases, expired products for credit. We base our estimate for sales returns upon historical trends and record the amount as a reduction to revenue when we sell the initial product.
We consider relevant evidence, both positive and negative, to determine the need for a valuation allowance. Information evaluated includes our financial position and results of operations for the current and preceding years, the availability of deferred tax liabilities and tax carrybacks, as well as estimates of the impact of future taxable income and available prudent and feasible tax-planning strategies.
Information evaluated includes our financial position and results of operations for the current and preceding years, the availability of deferred tax liabilities and tax carrybacks, as well as estimates of the impact of future taxable income and available prudent and feasible tax-planning strategies.
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). Other countries where we do business are also considering adopting the framework or are in various stages of enacting the framework into their country’s laws.
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).
We primarily used the net proceeds from the 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.
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.
In addition, significant uncertainty exists regarding the interpretation of the detailed Pillar Two rules, whether such rules will be implemented consistently across taxing jurisdictions, how such rules interact with existing national tax laws and whether such rules are consistent with existing tax treaty obligations.
However, Pillar Two remains enacted law and significant uncertainty exists regarding the implementation of the January 5 th guidance as well as 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.
Excluding these items, adjusted net income attributable to Boston Scientific common stockholders 3 for 2023 was $2.999 billion, or $2.05 per diluted share. 1 Operational net sales growth excludes the impact of foreign currency fluctuations. 2 Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. 3 Adjusted 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.
Adjusted measures, including operational and organic net sales growth, adjusted net income attributable to Boston Scientific common stockholders and adjusted net income per common share - diluted, 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 Critical Accounting Estimates for 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.
Intangible assets acquired from Devoro were impaired following management's decision to cancel the related program in the second quarter of 2024. Refer to Critical Accounting Estimates for 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.
(3) Lease obligations include minimum lease payments under our operating lease agreements. Refer to Note F – Leases to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K for more information.
(3) Lease obligations include minimum lease payments under our operating lease agreements, but exclude expected lease payments for lease terms that have not yet commenced. Refer to Note F – Leases to our consolidated financial statements included in Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report for more information.
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.
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.
The following table provides a summary of our range of estimates of total pre-tax charges associated with the 2023 Restructuring Plan by major type of cost: Type of Cost (in millions) Total Estimated Amount Expected to be Incurred Restructuring charges: Termination benefits (1) $ 60 - $ 80 Other (2) 20 - 40 Restructuring-related expenses: Transfer costs (3) 300 - 330 Other (4) 70 - 100 $ 450 - $ 550 (1) Plans detailing specific employee impacts will be developed for each affected region and business, working with employee representative bodies where required under local laws.
The following table provides a summary of cumulative pre-tax charges associated with the 2023 Restructuring Plan, including the expansion, by major type of cost: Type of Cost (in millions) Total Amount Incurred Restructuring charges: Termination benefits (1) $ 104 Other (2) 39 Restructuring-related expenses: Transfer costs (3) 312 Other (4) 213 $ 668 (1) Plans detailing specific employee impacts are developed for each affected region and business, working with employee representative bodies where required under local laws.
Accordingly, management excludes the impact of foreign currency fluctuations for purposes of reviewing net sales and growth rates to facilitate an evaluation of our current operating performance and a comparison to our past operating performance.
Accordingly, management excludes the impact of foreign currency fluctuations for purposes of reviewing net sales and growth rates to facilitate an evaluation of our current operating performance and a comparison to our past operating performance. 50 Organic Net Sales • Organic 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.
The following table presents our restructuring reserve balance: As of December 31, (in millions) 2024 2023 Restructuring reserve balance $ 26 $ 41 44 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 consolidated financial statements.
(2) These charges are primarily recorded within Cost of products sold, SG&A Expenses and R&D Expenses . 38 The following table presents our restructuring reserve balance: As of December 31, (in millions) 2025 2024 Restructuring reserve balance $ 59 $ 26 Litigation-related Net Charges (Credits) We record certain legal charges, credits and costs of defense, which we consider to be unusual or infrequent and significant as Litigation-related net charges (credits) within our consolidated financial statements.
Geopolitical developments, 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.
Further, geopolitical developments and uncertainties, including related to various ongoing global conflicts and tensions, may also create economic, supply chain, transportation, energy, and other challenges, including disruptions to our suppliers or our customers' operations, which could negatively impact our business and results of operations. 34 Results of Operations Net Sales The following section describes our net sales by reportable segment and business.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeThe communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. 64 Description of the Matter Valuation of intangible assets acquired in business combinations As disclosed in Note B to the consolidated financial statements, during 2024, the Company completed the acquisitions of Silk Road Medical, Inc. and Axonics, Inc. for purchase prices, net of cash acquired, of $1,126 million and $3,409 million, respectively.
Biggest changeThe communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. 57 Valuation of intangible assets acquired in business combinations Description of the Matter As disclosed in Note B to the consolidated financial statements, during 2025, the Company completed the acquisitions of Bolt Medical, Inc. and SoniVie Ltd. for purchase prices, net of cash acquired, of $782 million and $516 million, respectively.
Our interest rate risk relates primarily to U.S. dollar and euro-denominated borrowings partially offset by U.S. dollar cash investments. We have historically used interest rate derivative instruments to manage our earnings and cash flow exposure to changes in interest rates. We had no interest rate derivative instruments outstanding as of December 31, 2024 and December 31, 2023.
Our interest rate risk relates primarily to U.S. dollar and euro-denominated borrowings partially offset by U.S. dollar cash investments. We have historically used interest rate derivative instruments to manage our earnings and cash flow exposure to changes in interest rates. We had no interest rate derivative instruments outstanding as of December 31, 2025 and December 31, 2024.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles.
Financial Statements and Supplementary Data of this Annual Report on Form 10-K for further information regarding our derivative financial instruments. 63 Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Boston Scientific Corporation Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Boston Scientific Corporation and subsidiaries (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive income (loss) , stockholders' equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes and financial statement schedule listed in the Index at Item 15(a) (collectively referred to as the “consolidated financial statements”).
Financial Statements and Supplementary Data of this Annual Report on Form 10-K for further information regarding our derivative financial instruments. 56 Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Boston Scientific Corporation Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Boston Scientific Corporation and subsidiaries (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations, comprehensive income (loss), stockholders' equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes and financial statement schedule listed in the Index at Item 15(a) (collectively referred to as the “consolidated financial statements”).
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 18, 2025 expressed an unqualified opinion thereon.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 17, 2026 expressed an unqualified opinion thereon.
See Note D – Hedging Activities and Fair Value Measurements to our consolidated financial statements included in Item 8.
See Note D – Hedging Activities and Fair Value Measurements to our consolidated financial statements included in Part II, Item 8.
How We Addressed the Matter in Our Audit We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s accounting for business combination transactions. For example, we tested controls over the identification and valuation of intangible assets, including the underlying assumptions used to develop such estimates.
How We Addressed the Matter in Our Audit We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s accounting for business combination transactions. For example, we tested controls over the identification and valuation of intangible assets, including the methodology used by the Company and the significant assumptions used to develop such estimates.
A ten percent appreciation in the U.S. dollar’s value relative to the hedged currencies would increase the derivative instruments’ fair value by $322 million as of December 31, 2024 compared to $236 million as of December 31, 2023.
A ten percent appreciation in the U.S. dollar’s value relative to the hedged currencies would increase the derivative instruments’ fair value by $804 million as of December 31, 2025 compared to $322 million as of December 31, 2024.
A ten percent depreciation in the U.S. dollar’s value relative to the hedged currencies would decrease the derivative instruments’ fair value by $394 million as of December 31, 2024 compared to $288 million as of December 31, 2023.
A ten percent depreciation in the U.S. dollar’s value relative to the hedged currencies would decrease the derivative instruments’ fair value by $982 million as of December 31, 2025 compared to $394 million as of December 31, 2024.
We involved our valuation professionals to assist with our evaluation of the methodology used by the Company and significant assumptions included in the fair value estimates. /s/ Ernst & Young LLP We have served as the Company’s auditor since 1992. Boston, Massachusetts February 18, 2025 65
We involved our valuation professionals to assist with our evaluation of the methodology used by the Company and significant assumptions included in the fair value estimates. /s/ Ernst & Young LLP We have served as the Company’s auditor since 1992. Boston, Massachusetts February 17, 2026 58
We use both nonderivative (primarily European manufacturing operations) and derivative instruments to manage our earnings and cash flow exposure to changes in currency exchange rates. We had currency derivative instruments outstanding in the contract amount of $7.636 billion as of December 31, 2024 and $5.899 billion as of December 31, 2023.
We use both nonderivative (primarily European manufacturing operations) and derivative instruments to manage our earnings and cash flow exposure to changes in currency exchange rates. We had currency derivative instruments outstanding in the contract amount of $12.726 billion as of December 31, 2025 and $7.636 billion as of December 31, 2024.
The significant assumptions used to estimate the fair value of the intangible assets included discount rates and certain assumptions that form the basis of the forecasted results, including revenue growth rates, and EBITDA margins attributed to the assets. These significant assumptions are forward looking and could be affected by future economic and market conditions.
The significant assumptions used to estimate the fair value of the intangible assets included certain assumptions that form the basis of the forecasted results, including revenue growth rates and probability of regulatory success. These significant assumptions are forward-looking and could be affected by future economic and market conditions.
As of December 31, 2024, $10.451 billion in aggregate principal amount of our outstanding debt obligations were at fixed interest rates, representing approximately 98 percent of our total debt, on an amortized cost basis. As of December 31, 2024, our outstanding debt obligations at fixed interest rates were comprised of senior notes.
As of December 31, 2025, $11.343 billion in aggregate principal amount of our outstanding debt obligations were at fixed interest rates, representing approximately 100 percent of our total debt, on an amortized cost basis. As of December 31, 2025, our outstanding debt obligations at fixed interest rates were comprised of senior notes.
Auditing the Company’s accounting for the business combinations was complex due to the significant estimation required by management to determine the fair value of identified intangible assets, which totaled $1,749 million and principally consisted of developed technology. The Company used an income approach to measure the technology-related intangible assets acquired.
Auditing the Company’s accounting for its business combinations was complex due to the significant estimation required by management to determine the fair value of identified intangible assets, which consisted of $720 million of in-process research and development (“IPR&D”) and $142 million of developed technology. The Company used an income approach to measure the IPR&D and technology-related intangible assets acquired.