Boston Scientific

“Government and private sector initiatives related to limiting the growth of health care costs (including price regulation), coverage and payment policies, comparative effectiveness reviews of therapies, technology assessments, price transparency and health care delivery and payment structure reforms, are continuing in many countries where we do business.”

Annual report 2025A · The company itself

“Implementation of cost containment initiatives and health care reforms in significant markets such as the U.S., China, Australia, and other markets may limit the price of, or the level at which reimbursement is provided for, our products or procedures using our products, which in turn may make it less likely that a hospital or physician will select our products to treat patients.”

Annual report 2025A · The company itself

“In the current environment of managed care, with economically motivated buyers, consolidation among health care providers, increasing prevalence and importance of regional and national tenders, increased competition and declining reimbursement rates, we are also required to compete on the basis of price, value, reliability and efficiency.”

Annual report 2025A · The company itself

“Shifts in sites of care including migration of procedures from inpatient to outpatient, ambulatory surgical centers or office-based settings, and associated changes in coverage, reimbursement, payment terms and provider economics, may impact procedure volumes, product mix, and pricing and contracting.”

Annual report 2025A · The company itself

“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. Numerous initiatives and reforms by legislators, regulators and third-party payers to curb the rising cost of health care, and to increase access to care, have catalyzed a consolidation of aggregate purchasing power within the markets in which we sell our products. Additionally, a growing number of countries have instituted or are contemplating introducing regional or national tender processes driven primarily by price.”

Annual report 2025A · The company itself

“Governments and payers may institute changes in health care delivery or payment systems that may reduce funding for services or encourage greater scrutiny of health care costs. The ability of customers to obtain appropriate reimbursement for their products and services is critical to the success of medical technology companies because it affects which products customers purchase and the prices they are willing to pay.”

Annual report 2025A · The company itself

“Further, international markets are affected by economic pressure to contain health care costs, which can lead to more rigorous evidence requirements and lower reimbursement rates for either our products directly or procedures in which our products are used.”

Annual report 2025A · The company itself

“Legal and Regulatory Risk Factors Health care policy changes may have a material adverse effect on our business, financial condition, results of operations and cash flows. Political, economic and policy influences are leading the health care industry to make substantial structural and financial changes that will continue affecting our results of operations. Government and private sector initiatives aimed at limiting the growth of health care costs (including price regulation), coverage and payment policies, comparative effectiveness of therapies, technology assessments, increasing price transparency and reforming health care delivery and payment structures, are continuing in many countries where we do business.”

Annual report 2025A · The company itself

“We cannot predict the specific health care programs and regulations that will be ultimately implemented by various regional and national governments. However, any changes that lower reimbursements for either our products and/or procedures using our products reduce medical procedure volumes and/or increase cost containment pressures on us or others in the health care sector could adversely affect our business and results of operations.”

Annual report 2025A · The company itself

“Marketing and Sales We market our products and solutions to hospitals, clinics, outpatient facilities and medical offices in 127 countries worldwide.”

Annual report 2025A · The company itself

“In addition, large group purchasing organizations, hospital networks and other buying groups are important to our business and represent a substantial portion of our net sales.”

Annual report 2025A · The company itself

“Our products are purchased principally by hospitals, physicians and other health care providers around the world that typically bill various third-party payers, including government programs (e.g., Medicare and Medicaid in the U.S.) and private insurance payers, for the items and services provided to their patients.”

Annual report 2025A · The company itself

“Marketing and Sales We market our products and solutions to hospitals, clinics, outpatient facilities and medical offices in 127 countries worldwide. In addition, large group purchasing organizations, hospital networks and other buying groups are important to our business and represent a substantial portion of our net sales.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“Research and Development Our investment in research and development is critical to driving our future growth. 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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“Product Offerings Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“Neuromodulation Our Neuromodulation business unit develops and manufactures devices to treat various neurological movement disorders and manage chronic pain.”

Annual report 2025A · The company itself

“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. 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).”

Annual report 2025A · The company itself

“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. WATCHMAN™ is the first device to offer a non-pharmacologic alternative to oral anti-coagulants that has been studied in a randomized clinical trial and is the leading device in percutaneous LAAC globally.”

Annual report 2025A · The company itself

“Electrophysiology Our Electrophysiology business unit develops and manufactures less-invasive medical technologies used in the diagnosis and treatment of rate and rhythm disorders of the heart, including a broad portfolio of therapeutic and diagnostic catheters and a variety of equipment used in the Electrophysiology lab.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“Interventional Oncology and Embolization Our Interventional Oncology and Embolization business unit develops and manufactures products to treat various forms of cancer.”

Annual report 2025A · The company itself

“Our products are designed and manufactured in technology centers around the world, either by us or third parties. In most cases, the manufacturing of any specific product is concentrated in one or a few locations.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“New competitors may emerge in the future, potentially including companies introducing new sales or distribution models to our industry or leveraging genomic, robotic, navigation, and/or other automation technologies.”

Annual report 2025A · The company itself

“This includes emerging technologies which increase our threat landscape, such as generative AI and quantum computing, which are evolving rapidly in their practicality and use for cyber-attacks including through enhanced social engineering, and for cyber-attacks on industry standard data protections through increased computing capabilities.”

Annual report 2025A · The company itself

“Our information systems require an ongoing commitment of significant resources to maintain, protect and enhance existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving systems and regulatory standards, the increasing need to protect patient and customer information and changing customer patterns. This includes opportunities as well as risks associated with the integration of AI into our or our suppliers' or customers' operations. While AI presents significant opportunities for innovation and efficiency, it could introduce new risks in managing information systems and in the cybersecurity threat landscape.”

Annual report 2025A · The company itself

“Our research and development efforts are focused largely on the development of next-generation and novel technology offerings across multiple programs and all divisions.”

Annual report 2025A · The company itself

“We continue to develop digital tools and technologies that enable us to compete more effectively and deliver first class remote physician education, drive deeper patient engagement and increase digitally-enabled sales force productivity.”

Annual report 2025A · The company itself

“We continue to transform how we conduct research and development by identifying best practices, driving efficiencies and optimizing our cost structure, which we believe will enable increased development activity and faster concept-to-market timelines.”

Annual report 2025A · The company itself

“Digital technologies, including artificial intelligence (AI) and machine learning capabilities, have and may continue to increase in their applicability and importance to various aspects of our business, operating and competitive environments, research and development (R&D) pipeline and product portfolio. We believe we will need to develop new and enhanced digital capabilities and competences in order to remain competitive.”

Annual report 2025A · The company itself

“We may not effectively be able to protect our intellectual property, systems, software-based products or other sensitive data, which could have a material adverse effect on our business, financial condition or results of operations. The medical device market in which we participate is largely technology driven.”

Annual report 2025A · The company itself

“If we are unable to attract or retain key talent, it could have an adverse effect on our business, financial condition and results of operations. In our industry, there is substantial competition for key personnel in the regions in which we operate and we may face increased competition for such employees.”

Annual report 2025A · The company itself

“The same economic conditions could also adversely affect our third-party vendors, including those that we utilize in our supply-chain and manufacturing operations, which may lead to a reduction or interruption in the supply of materials and components used in manufacturing our products or increase the price of such materials or components, as well as the distributors and dealers who offer our products in certain countries and markets. Continued inflationary pressure may also increase certain operational costs, including due to 14 wage increases, or increases in the cost of materials or components.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“As of December 31, 2025, we had approximately 59,000 employees, of which approximately 60 percent were outside the U.S.”

Annual report 2025A · The company itself

“Attracting, developing and retaining talented employees are key parts of our strategy and are critical to our success. We strive to do this by fostering a diverse, equitable and inclusive workplace, providing competitive pay and benefits and flexible work conditions, offering ongoing employee growth and development opportunities and cultivating a culture that prioritizes employee health, safety and well-being.”

Annual report 2025A · The company itself

“An important part of our strategy is to continue pursuing growth opportunities in net sales and market share outside of the U.S. by expanding global presence, including in Emerging Markets.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“New competitors may emerge in the future, potentially including companies introducing new sales or distribution models to our industry or leveraging genomic, robotic, navigation, and/or other automation technologies.”

Annual report 2025A · The company itself

“We continue to transform how we conduct research and development by identifying best practices, driving efficiencies and optimizing our cost structure, which we believe will enable increased development activity and faster concept-to-market timelines.”

Annual report 2025A · The company itself

“Resources Manufacturing and Raw Materials We are focused on continuously improving our supply chain effectiveness, strengthening our manufacturing processes and increasing operational efficiencies within our organization worldwide. In doing so, we seek to focus our internal resources on the development and commercial launch of new products and the enhancement of existing products.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“It is necessary for us to devote continued efforts and financial resources to the development or acquisition of scientifically advanced technologies and products.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“We continue to develop digital tools and technologies that enable us to compete more effectively and deliver first class remote physician education, drive deeper patient engagement and increase digitally-enabled sales force productivity.”

Annual report 2025A · The company itself

“In addition to internal development, we work with leading research institutions, universities and clinicians around the world to develop, evaluate and clinically test our products.”

Annual report 2025A · The company itself

“Maintaining and expanding our international presence is an important component of our long-term growth strategy. Through our international presence, we seek to increase net sales and market share, leverage our relationships with leading physicians and their clinical research programs, accelerate the time to bring new products to market and gain access to worldwide technological developments that we can implement across our product lines.”

Annual report 2025A · The company itself

“Marketing and Sales We market our products and solutions to hospitals, clinics, outpatient facilities and medical offices in 127 countries worldwide. In addition, large group purchasing organizations, hospital networks and other buying groups are important to our business and represent a substantial portion of our net sales.”

Annual report 2025A · The company itself

“In addition, several countries that previously did not have regulatory requirements for medical devices have established such requirements in recent years and other countries have expanded, or plan to expand, existing regulations, including requiring local clinical data in addition to global clinical data.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“We are subject to extensive and dynamic medical device regulation, which may impede or hinder the approval or sale of our products and, in some cases, may ultimately result in an inability to obtain approval of certain products or may result in the recall or seizure of previously approved products. Our products, marketing, sales and development activities and manufacturing processes are subject to extensive and rigorous regulation by the FDA pursuant to the Federal Food, Drug and Cosmetic Act (FDC Act), by comparable agencies in foreign countries and by other regulatory agencies and governing bodies. 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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“Most countries outside of the U.S. require that product approvals be renewed or recertified on a regular basis, generally every four to five years. The renewal or recertification process requires that we evaluate any device changes and any new regulations or standards relevant to the device and conduct appropriate testing to document continued compliance.”

Annual report 2025A · The company itself

“Our global regulatory environment is becoming increasingly stringent and unpredictable, which could increase the time, cost and complexity of obtaining regulatory approvals, as well as the clinical and regulatory costs of supporting those approvals. Several countries that did not previously have regulatory requirements for medical devices have established such requirements in recent years and other countries have expanded on existing regulations.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“In the current environment of managed care, with economically motivated buyers, consolidation among health care providers, increasing prevalence and importance of regional and national tenders, increased competition and declining reimbursement rates, we are also required to compete on the basis of price, value, reliability and efficiency.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“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. In general, the scope and complexity of regulations applicable to our business has increased over time.”

Annual report 2025A · The company itself

“We are subject to a wide range of global privacy, data‑protection, and cross‑border data‑transfer laws. In the United States, federal and state regulations govern the confidentiality and security of personal information, including health data. In the European Union, the General Data Protection Regulation (GDPR) imposes strict requirements and significant potential penalties. China’s data‑protection and cross‑border transfer laws, including requirements under the Personal Information Protection Law (PIPL) and related regulations, impose strict obligations on how data involving Chinese individuals may be handled, along with similar regulations in other jurisdictions, impose additional obligations on how personal data may be collected, stored, and transferred, including data‑localization and government‑approval requirements.”

Annual report 2025A · The company itself

“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. Unless these incentives and grants are extended, they will expire between 2028 and 2034.”

Annual report 2025A · The company itself

“The same economic conditions could also adversely affect our third-party vendors, including those that we utilize in our supply-chain and manufacturing operations, which may lead to a reduction or interruption in the supply of materials and components used in manufacturing our products or increase the price of such materials or components, as well as the distributors and dealers who offer our products in certain countries and markets. Continued inflationary pressure may also increase certain operational costs, including due to 14 wage increases, or increases in the cost of materials or components.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“We rely on the proper function, availability and security of information technology systems to operate our business and a cyber-attack or other breach of these systems could have a material adverse effect on our business, financial condition or results of operations. 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.”

Annual report 2025A · The company itself

“Our information systems require an ongoing commitment of significant resources to maintain, protect and enhance existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving systems and regulatory standards, the increasing need to protect patient and customer information and changing customer patterns. This includes opportunities as well as risks associated with the integration of AI into our or our suppliers' or customers' operations. While AI presents significant opportunities for innovation and efficiency, it could introduce new risks in managing information systems and in the cybersecurity threat landscape.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“We are subject to certain U.S. tariffs that are currently subject to legal challenge before the U.S. Supreme Court. The timing and outcome of this litigation are uncertain, and the Court’s decision could result in the modification, invalidation, or continuation of such tariffs. 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.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“In addition, third parties have and may continue to attempt to hack into our products to obtain data relating to patients, or alter the intended functionality of our medical devices, or disrupt performance of our products, or access our proprietary information and the technology from third party vendors that we rely upon may have defects or vulnerabilities which, in turn, create vulnerabilities or disruptions in our system. Cyber-attacks continue to evolve in complexity and scope, and inherently may be difficult to detect.”

Annual report 2025A · The company itself

“We rely on the proper function, availability and security of information technology systems to operate our business and a cyber-attack or other breach of these systems could have a material adverse effect on our business, financial condition or results of operations. 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.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“In the EU, we are required to comply with the Medical Device Regulation (MDR), which became effective in May 2021 and changed multiple aspects of the regulatory framework for CE Marking, including increased compliance requirements for the medical device industry.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“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. While we continue to believe we will have access to the raw materials and components that we need, these supply chain dynamics could result in increased costs to us or an inability to fully meet customer demand for certain of our products.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“Additionally, U.S. and international governments have or are considering adopting regulations on the use of per- and polyfluoroalkyl substances (PFAS), and primary manufacturers of PFAS materials have announced that they are discontinuing the supply of such materials. These changes could have an adverse impact on our ability to manufacture or supply certain products in a timely or cost-effective manner or at all.”

Annual report 2025A · The company itself

“Natural disasters, extreme weather and other conditions caused by or related to climate change could adversely impact our supply chain, including manufacturing and distribution networks, the availability and cost of raw materials and components, energy supply, transportation, or other inputs necessary for the operation of our business.”

Annual report 2025A · The company itself

“Increasingly, payers and health systems require robust health economic evidence and real world outcomes data, including comparative effectiveness, budget impact, and total cost of care analysis, to support coverage, procurement, and continue use, which may require us to fund post-market studies, registries, or other evidence generated in the respective country to maintain or expand access.”

Annual report 2025A · The company itself

“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. In general, the scope and complexity of regulations applicable to our business has increased over time.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“In addition, global pandemics or other public health crises could cause disruptions in global economic activity, global supply chains and labor markets, operational challenges such as site shutdowns, workplace disruptions or limited provider capacity to perform procedures using our products, and significant volatility in price and availability of goods and services.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“Government and private sector initiatives aimed at limiting the growth of health care costs (including price regulation), coverage and payment policies, comparative effectiveness of therapies, technology assessments, increasing price transparency and reforming health care delivery and payment structures, are continuing in many countries where we do business. We believe that these changes are causing the marketplace to place increased emphasis on the delivery of treatments that can reduce costs, improve efficiencies and/or increase patient access.”

Annual report 2025A · The company itself

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

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“PROPERTIES Our world headquarters is located in the U.S, in Marlborough, Massachusetts, with principal regional headquarters located in Singapore and Voisins-le-Bretonneux, France. 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.”

Annual report 2025A · The company itself

“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.”

Annual report 2025A · The company itself

“PROPERTIES Our world headquarters is located in the U.S, in Marlborough, Massachusetts, with principal regional headquarters located in Singapore and Voisins-le-Bretonneux, France. 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.”

Annual report 2025A · The company itself