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What changed in Becton Dickinson's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Becton Dickinson'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.

+432 added−408 removedSource: 10-K (2025-11-25) vs 10-K (2024-11-27)

Top changes in Becton Dickinson's 2025 10-K

432 paragraphs added · 408 removed · 310 edited across 9 sections

Item 1. Business

Business — how the company describes what it does

72 edited+27 added−38 removed41 unchanged
Biggest changeBD Life Sciences consists of the following organizational units: Organizational Unit Principal Product Lines Integrated Diagnostic Solutions Integrated systems for specimen collection; safety-engineered blood collection products and systems; automated blood culturing and tuberculosis culturing systems; molecular testing systems for infectious diseases and women’s health; microorganism identification and drug susceptibility systems; liquid-based cytology systems and HPV tests for cervical cancer screening and genotyping; rapid diagnostic assays for testing of respiratory infections at the point of care; microbiology laboratory automation; and plated media for clinical and industrial applications.
Biggest changeBD Life Sciences consists of the following organizational units: 2 Table of Contents Organizational Unit Principal Product Lines Diagnostic Solutions Automated blood culturing and tuberculosis culturing systems; microorganism identification and drug susceptibility systems; microbiology laboratory automation and informatics; dehydrated, liquid and plated media for clinical and industrial microbiology applications; molecular testing systems for infectious diseases and women’s health; and rapid diagnostic assays for testing of respiratory infections at point of care.
Additionally, over the last several years in the U.S., we have increased efforts to mitigate the impact of rising healthcare costs and to offer more cost effective benefit options, with a specific focus on affordability for BD associates earning $55,000 per year or less.
Additionally, over the last several years in the U.S., we have increased efforts to mitigate the impact of rising healthcare costs and offer more cost-effective benefit options, with a specific focus on affordability for BD associates earning $55,000 per year or less.
BD Medical consists of the following organizational units: 1 Table of Contents Organizational Unit Principal Product Lines Medication Delivery Solutions Peripheral intravenous ("IV") catheters (conventional, safety); advanced peripheral catheters (guidewire assisted peripherally inserted venous catheters, midline catheters, port access); central lines (peripherally inserted central catheters); acute dialysis catheters; vascular access technology (ultrasonic imaging); vascular care (lock solutions, prefilled flush syringes, disinfecting caps); vascular preparation (skin antiseptics, dressings, securement); needle-free IV connectors and extensions sets; closed-system drug transfer devices; hazardous drug detection; conventional and safety hypodermic syringes and needles, anesthesia needles (spinal, epidural) and trays; enteral syringes; and sharps disposal systems.
BD Medical consists of the following organizational units: 1 Table of Contents Organizational Unit Principal Product Lines Medication Delivery Solutions Peripheral intravenous (“IV”) catheters (conventional, safety); advanced peripheral catheters (guidewire assisted peripherally inserted venous catheters, midline catheters, port access); central lines (peripherally inserted central catheters); acute dialysis catheters; vascular access technology (ultrasonic imaging); vascular care (lock solutions, prefilled flush syringes, disinfecting caps); vascular preparation (skin antiseptics, dressings, securement); needle-free IV connectors and extensions sets; closed-system drug transfer devices; hazardous drug detection; conventional and safety hypodermic syringes and needles, anesthesia needles (spinal, epidural) and trays; enteral syringes; and sharps disposal systems.
To enable associates to take action in support of their overall well-being, our total rewards packages (which vary by location) include market-competitive pay, broad-based stock grants and bonuses, healthcare benefits and retirement savings plans, paid time off and family leave, flexible work schedules, on-site health and fitness centers, free physicals and flu vaccinations, well-being education and resources, employee assistance programs and other mental health support and resources.
To enable associates to take action in support of their overall well-being, our total rewards packages (which vary by level and location) include market-competitive pay, broad-based stock grants and bonuses, healthcare benefits and retirement savings plans, paid time off and family leave, flexible work schedules, on-site health and fitness centers, free physicals and flu vaccinations, well-being education and resources, employee assistance programs and other mental health support and resources.
BD uses acute care, non-acute care, laboratory and drug wholesaler distributors to broadly support our overall disposable product demand from our end user customers in the United States, while our capital equipment is mostly sold direct to our end user customers. In international markets, products are distributed either directly or through distributors, with the practice varying by country.
In the United States, BD uses acute care, non-acute care, laboratory and drug wholesaler distributors to broadly support our overall disposable product demand from our end user customers, while our capital equipment is mostly sold direct to our end user customers. In international markets, BD’s products are distributed either directly or through distributors, with the practice varying by country.
While BD works closely with its suppliers, no assurance can be given that these efforts will be successful, and there may be events that cause supply interruption, reduction or termination that adversely impact BD’s ability to manufacture and sell certain products. See further discussion of the risks related to the supply chain and raw materials in Item 1A. Risk Factors.
While BD works closely with its suppliers, no assurance can be given that these efforts will be successful, and there may be events that cause supply interruption, reduction or termination that adversely impact BD’s ability to manufacture and sell certain products. See further discussion of the risks related to the supply chain and raw materials in Item 1A.
Printed copies of these materials, this 2024 Annual Report on Form 10-K, and BD’s reports and statements filed with, or furnished to, the SEC, may also be obtained, without charge, by contacting the Corporate Secretary, BD, 1 Becton Drive, Franklin Lakes, New Jersey 07417-1880, telephone 201-847-6800.
Printed copies of these materials, this 2025 Annual Report on Form 10-K, and BD’s reports and statements filed with, or furnished to, the SEC, may also be obtained, without charge, by contacting the Corporate Secretary, BD, 1 Becton Drive, Franklin Lakes, New Jersey 07417-1880, telephone 201-847-6800.
In order to provide alternate sources, BD must complete a rigorous qualification process, which most often includes completion of regulatory registration and approval. If clinical trials are not required, this qualification process can take 3-18 months depending on the criticality of the change. When clinical trials are required, this process may lengthen the qualification phase from one to three years.
To provide alternate sources, BD must complete a rigorous qualification process, which most often includes completion of regulatory registration and approval. If clinical trials are not required, this qualification process can take 3-18 months depending on the criticality of the change. When clinical trials are required, this process may lengthen the qualification phase from one to three years.
Governments around the world continue to consider and transition to value-based payment reforms that would drive improved value and quality- and resource-based reimbursement. For example, the Centers for Medicare & Medicaid Services’ (CMS) established a 2030 goal of transitioning all Medicare fee-for-service beneficiaries to a “care relationship” to ensure the agency’s accountability of quality and cost of care.
Governments around the world continue to consider and transition to value-based payment reforms that would drive improved value and quality- and resource-based reimbursement. For example, the Centers for Medicare & Medicaid Services’(“CMS”) established a 2030 goal of transitioning all Medicare fee-for-service beneficiaries to a “care relationship” to ensure the agency’s accountability of quality and cost of care.
Urology and Critical Care Urine management and measurement devices, indwelling, intermittent and external urine catheters, kidney stone management devices, Targeted Temperature Management, and fecal management devices. Acquisitions Edwards Lifesciences’ Critical Care Product Group On September 3, 2024, BD completed the acquisition of Critical Care, which was renamed as BD Advanced Patient Monitoring.
Urology and Critical Care Urine management and measurement devices, indwelling, intermittent and external urine catheters, kidney stone management devices, Targeted Temperature Management, and fecal management devices. 3 Table of Contents Acquisitions Edwards Lifesciences’ Critical Care Product Group On September 3, 2024, BD completed the acquisition of Edwards Lifesciences’ Critical Care product group, which was renamed as BD Advanced Patient Monitoring.
As noted above, on November 22, 2024, BD received the Dispensing Warning Letter following an inspection of its facility located in San Diego, California, citing certain alleged violations of the quality system regulations, MDR regulation, the corrections and removals reporting regulation and law.
As noted above, on November 22, 2024, BD received the Dispensing Warning Letter following an inspection of its Dispensing quality management system at its facility located in San Diego, California, citing certain alleged violations of the quality system regulations, MDR regulation, the corrections and removals reporting regulation and law.
The fair value of consideration transferred in connection with the acquisition was $3.911 billion. Since the acquisition date, financial results for Advanced Patient Monitoring’s product offerings are being reported as a separate organizational unit within the Medical segment.
The fair value of consideration transferred in connection with the acquisition was $3.914 billion. Since the acquisition date, financial results for Advanced Patient Monitoring’s product offerings are being reported as a separate organizational unit within the Medical segment.
BD’s worldwide sales are not generally seasonal, with the exception of certain medical devices in the Medication Delivery Solutions business unit, and flu diagnostic products in the Integrated Diagnostic Systems business unit, both of which relate to seasonal diseases such as influenza.
BD’s worldwide sales are not generally seasonal, with the exception of certain medical devices in the Medication Delivery Solutions business unit, and flu diagnostic products in the Diagnostic Solutions business unit, both of which relate to seasonal diseases such as influenza.
Consent Decree with FDA Our U.S. infusion pump organizational unit is operating under an amended consent decree originally entered into by Cardinal Health 303, Inc. with the FDA in 2007 related to its Alaris™ SE infusion pumps.
Consent Decree with FDA Our U.S. infusion pump organizational unit is operating under an amended consent decree originally entered into by Cardinal Health 303, Inc. with the FDA in 2007 related to its Alaris TM infusion pumps.
Through our integrated global approach to well-being, we provide support, education, and resources to empower associates across all geographies to prioritize their well-being and build resilience in the physical, emotional, financial, and social areas of life.
Through our integrated global approach to well-being, we provide support, education and resources to help empower associates across all levels and geographies to prioritize their well-being and build resilience in the physical, emotional, financial and social areas of life.
BD operates consolidated distribution facilities globally in order to better service its customers, optimize logistics, lower facilities costs and reduce finished goods inventory levels. 4 Table of Contents Raw Materials and Components BD purchases many different types of raw materials and components, including plastics, glass, metals, textiles, paper products, agricultural products, electronic and mechanical sub-assemblies and various biological, chemical and petrochemical products.
BD operates consolidated distribution facilities globally in order to better service its customers, optimize logistics, lower facilities costs and reduce finished goods inventory levels. Raw Materials and Components BD purchases many different types of raw materials and components, including plastics, glass, metals, textiles, paper products, agricultural products, electronic and mechanical sub-assemblies and various biological, chemical and petrochemical products.
In December 2021, the FDA issued to CareFusion 303, Inc. a letter of non-compliance with respect to the Consent Decree (the “Non-Compliance Letter”) stating that, among other things, it had determined that certain of the corrective actions with respect to the 2020 Form 483 Notice appeared to be adequate, some were still in progress such that adequacy could not be determined yet, and certain others were not adequate (e.g., complaint handling and 7 Table of Contents corrective and preventive actions, design verification and medical device reporting).
In December 2021, the FDA issued to CareFusion 303, Inc. a letter of non-compliance with respect to the Consent Decree (the “Non-Compliance Letter”) stating that, among other things, it had determined that certain of the corrective actions to address the 2020 Form 483 Notice appeared to be adequate, some were still in progress such that adequacy could not be determined yet, and certain others were not adequate (e.g., complaint handling and corrective and preventive actions, design verification and medical device reporting).
Other firms engaged in the distribution of medical technology products have become manufacturers of medical devices and instruments as well. Acquisitions and collaborations by and among companies seeking a competitive advantage also affect the competitive environment. In addition, the entry into the market of low- 5 Table of Contents cost manufacturers has created increased pricing pressures.
Other firms engaged in the distribution of medical technology products have become manufacturers of medical devices and instruments as well. Acquisitions and collaborations by and among companies seeking a competitive advantage also affect the competitive environment. In addition, the entry into the market of low-cost manufacturers has created increased pricing pressures.
Additional disclosures regarding our spin-off of the Diabetes Care business are provided in Note 2 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data, which is incorporated herein by reference. International Operations BD’s products are manufactured and sold worldwide.
Additional disclosures regarding our spin-off of the Diabetes Care business are provided in Note 2 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data, which is incorporated herein by reference. 4 Table of Contents International Operations BD’s products are manufactured and sold worldwide.
As of September 30, 2024, we do not believe that a loss is probable in connection with the Consent Decree, and accordingly, we have no accruals associated with compliance with the Consent Decree.
As of September 30, 2025, we do not believe that a loss is probable in connection with the Consent Decree, and accordingly, we have no accruals associated with compliance with the Consent Decree.
The scope of the activities of these agencies, particularly in the Europe, Japan, Latin America, and Asia Pacific regions in which BD operates, has been increasing. 6 Table of Contents In order to market or sell most of its products, BD must secure authorization from the FDA and counterpart foreign regulatory agencies.
The scope of the activities of these agencies, particularly in the Europe, Japan, Latin America and Asia Pacific regions in which BD operates, has been increasing. In order to market or sell most of its products, BD must secure authorization from the FDA and counterpart foreign regulatory agencies.
In March 2020, the FDA conducted a subsequent inspection of PAS, which it classified as 8 Table of Contents Voluntary Action Indicated, which means the FDA will not take or recommend any administrative or regulatory action as a result of the unit’s response to the observations associated with the quality management concerns in the inspection.
In March 2020, the FDA conducted a subsequent inspection of PAS which it classified as Voluntary Action Indicated, which means the FDA will not take or recommend any administrative or regulatory action as a result of the unit’s response to the observations associated with the quality management concerns in the inspection.
In addition, CareFusion 303, Inc. received an additional Form 483 Notice in May 2024 following an FDA inspection (“2024 Form 483 Notice”) that contained observations related to the site’s compliance with the FDA’s quality system regulations and MDR regulation related to its Infusion quality management system (covered by the Consent Decree) and separate Dispensing quality management system (which is not subject of the Consent Decree).
In addition, CareFusion 303, Inc. received an additional Form 483 Notice in May 2024 following an FDA inspection (“2024 Form 483 Notice”) that contained observations related to the site’s compliance with the FDA’s quality system regulation (“QSR”) for its Infusion quality management system (covered by the Consent Decree) and QSR and MDR regulation for its separate Dispensing quality management system (which is not subject of the Consent Decree).
Our website and the information contained therein or connected thereto shall not be deemed to be incorporated into this Annual Report. Forward-Looking Statements BD and its representatives may from time-to-time make certain forward-looking statements in publicly-released materials, both written and oral, including statements contained in filings with the SEC and in its reports to shareholders.
Our website and the information contained therein or connected thereto shall not be deemed to be incorporated into this Annual Report. Forward-Looking Statements BD and its representatives may from time-to-time make certain forward-looking statements in publicly-released materials, both written and oral, including statements contained in filings with the SEC and in its 12 Table of Contents reports to shareholders.
To this end, BD has proactively installed fugitive emissions controls at our 9 Table of Contents facilities in East Columbus, NE and Sandy, UT. On April 5, 2024, the final National Emission Standards for Hazardous Air Pollutants (“NESHAP”): Ethylene Oxide Emissions Standards for Sterilization Facilities regulation issued by the EPA became effective.
To this end, BD has proactively installed fugitive emissions controls at our facilities in East Columbus, NE and Sandy, UT. On April 5, 2024, the final National Emission Standards for Hazardous Air Pollutants (“NESHAP”): Ethylene Oxide Emissions Standards for Sterilization Facilities regulation issued by the EPA became effective.
As previously disclosed, on July 21, 2023, BD received 510(k) clearance from the FDA for its updated BD Alaris™ Infusion System, which enables both remediation and a return to market for the BD Alaris™ Infusion System. This clearance covers updated hardware features for Point-of-Care Unit (PCU), large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules.
As previously disclosed, on July 21, 2023, BD received 510(k) clearance from the FDA for its updated BD Alaris™ Infusion System, which enabled both remediation and a return to market for the BD Alaris™ Infusion System. This clearance covers updated hardware features for Point-of-Care Unit (“PCU”), large volume pumps, syringe pumps, patient-controlled analgesia (“PCA”) pumps, respiratory monitoring and auto-identification modules.
BD seeks to ensure continuity of supply by securing multiple options for sourcing. However, there are situations where raw materials and components are only available from one supplier, which are referred to as sole sourced.
BD seeks to ensure continuity of supply by securing multiple options for sourcing. However, there are situations where raw materials and components may only be obtained from one supplier, which are referred to as sole sourced.
The determination as to whether or not a modification or series of modifications could significantly affect the device’s safety or effectiveness is initially left to the manufacturer to assess using available guidance; however, regulators may review this determination to evaluate the regulatory status of the modified product at any time and may require the manufacturer to cease marketing and recall the modified device until a new marketing authorization is obtained.
The determination as to whether or not a modification or series of modifications require a new marketing authorization is initially left to the manufacturer to assess using available guidance; however, regulators may review this determination to evaluate the regulatory status of the modified product at any time and may require the manufacturer to cease marketing and recall the modified device until a new marketing authorization is obtained.
Per the terms of the Non-Compliance Letter, CareFusion 303, Inc. provided the FDA with a proposed comprehensive corrective action plan (“CAP”) and has retained an independent expert to conduct periodic audits of the CareFusion 303, Inc. infusion pump facilities through 2025.
Per the terms of the Non-Compliance Letter, CareFusion 303, Inc. provided the FDA with a proposed comprehensive corrective action plan (“CAP”) and has retained an independent expert to conduct periodic audits of the quality management system operating at the CareFusion 303, Inc. infusion pump facilities through 2025.
Additional information regarding BD’s forward-looking statements is contained in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Additional information regarding BD’s forward-looking statements is contained in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 13 Table of Contents
Ethylene oxide is the most frequently used sterilant for medical devices and healthcare products in the U.S., and in certain cases is the only option to sterilize critical medical device products for the safe administration to patients.
Ethylene oxide is the most frequently used sterilant for medical devices and healthcare products in the United States, and in certain cases is the only option to sterilize critical medical device products for the safe administration to patients.
In 2009, the decree was amended (the “Consent Decree”) to include all infusion pumps manufactured by or for CareFusion 303, Inc., which was acquired by BD in 2015. CareFusion 303, Inc. remains the legal manufacturer of BD Alaris™ infusion pumps. The Consent Decree does not apply to intravenous administration sets and accessories.
In 2009, the decree was amended (the “Consent Decree”) to include all infusion pumps manufactured by or for CareFusion 303, Inc., which was acquired by BD in 2015. CareFusion 303, Inc. remains the manufacturer of BD Alaris TM infusion pumps. The Consent Decree is specific to infusion pumps and does not apply to intravenous administration sets, accessories, or other products.
BD believes, however, that no single patent, technology, trademark, intellectual property asset or license is material in relation to BD’s business as a whole, or to any business segment. Competition BD operates in the increasingly complex and challenging medical technology marketplace.
In the aggregate, these intellectual property assets and licenses are of material importance to BD’s business. BD believes, however, that no single patent, technology, trademark, intellectual property asset or license is material in relation to BD’s business as a whole, or to any business segment. Competition BD operates in the increasingly complex and challenging medical technology marketplace.
Regulation General BD's operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, occupational health and safety, antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), export control, product safety and efficacy, employment, privacy and other areas.
Regulation General BD's operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, occupational health and safety, antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), export control, transportation, product safety and efficacy, employment, labor, privacy and data protection, customs, exports, artificial intelligence (“AI”) and other areas.
BD’s medical technology products and operations are subject to regulation by the U.S. Food and Drug Administration (“FDA”) and various other federal and state agencies, as well as by foreign governmental agencies. These agencies enforce laws and regulations that govern the development, testing, manufacturing, labeling, advertising, marketing and distribution, and market surveillance of BD’s medical products.
Food and Drug Administration (“FDA”) and various other federal and state agencies, as well as by foreign governmental agencies. These agencies enforce laws and regulations that govern the development, testing, manufacturing, labeling, advertising, marketing and distribution, and market surveillance of BD’s medical products.
As requested by the Dispensing Warning Letter, BD is preparing a comprehensive response to address FDA’s feedback in the Dispensing Warning Letter, which may include implementing additional corrective actions; however, no assurances can be given regarding further action by the FDA as a result of the noted non-conformities, or that corrective actions proposed and taken by CareFusion 303, Inc. will be adequate to address the non-conformities.
BD submitted a comprehensive response to address FDA’s feedback in the Dispensing Warning Letter, which committed to implementing additional corrective actions; however, no assurances can be given regarding further action by the FDA as a result of FDA’s Dispensing Warning Letter, or that corrective actions proposed and taken by CareFusion 303, Inc. will be adequate to address the Dispensing Warning Letter.
BD actively maintains Quality Systems that establish standards for its product design, manufacturing, and distribution processes, in accordance with ISO standards and FDA regulation. These agencies engage in periodic reviews and inspections of BD’s quality systems, as well as product performance and advertising and promotional materials.
BD actively maintains quality systems that establish standards for its product design, manufacturing, and distribution processes, in accordance with International Organization for Standardization standards and FDA regulations. Regulatory agencies engage in periodic reviews and inspections of BD’s quality systems, as well as product performance and advertising and promotional materials.
Following an inspection that began in March 2020 of our Medication Management Systems facility in San Diego, California (CareFusion 303, Inc.), the FDA issued a Form 483 Notice (the “2020 Form 483 Notice”) that contained a number of observations regarding the site’s compliance with FDA’s Quality System, reporting of corrections and removals, and Medical Device Reporting (MDR) regulations.
Following an inspection that began in March 2020 of our Medication Management Systems’ Infusion quality management system operating out of the site in San Diego, California (CareFusion 303, Inc.), the FDA issued a Form 483 Notice (the “2020 Form 483 Notice”) that contained a number of observations regarding the quality system’s compliance with FDA’s Quality System, reporting of corrections and removals, and Medical Device Reporting (“MDR”) regulations.
After a device has received 510(k) clearance, premarket (PMA) approval or other marketing authorization for a specific intended use, any change or modification that significantly affects its safety or effectiveness, such as a significant change or changes in the design, materials, method of manufacture or intended use, may require a new marketing authorization.
After a device has received 510(k) clearance, premarket (PMA) approval or other marketing authorization for a specific intended use, certain changes, such as a significant change or changes in the design, materials, method of manufacture or intended use, may require a new marketing authorization.
Each year we review and implement program enhancements and investments to ensure our benefits are inclusive and representative of the needs of BD associates and their families.
We periodically review and implement program enhancements and investments to help ensure that our benefits are representative of the needs of BD associates and their families.
FDA Warning Letters On January 11, 2018, BD received a Warning Letter from the FDA with respect to our former BD Preanalytical Systems ("PAS") unit, citing certain alleged violations of quality system regulations and of law.
Additionally, on April 25, 2025, BD received 510(k) clearance from the FDA on an updated BD Alaris™ Infusion System. FDA Warning Letters On January 11, 2018, BD received a Warning Letter from the FDA with respect to our former BD Preanalytical Systems ("PAS") unit, citing certain alleged violations of quality system regulations and of law.
We may be obligated to pay more costs in the future because, among other things, the FDA may determine that we are not fully compliant with the Consent Decree and Non-Compliance Letter and therefore impose penalties under the Consent Decree, and/or we may also be subject to future proceedings and litigation relating to the matters addressed in the Consent Decree, including, but not limited to, additional fines, penalties, other monetary remedies, and expansion of the terms of the Consent Decree.
We may be required to pay damages of $15,000 per day per violation if we fail to comply with any provision of the Consent Decree, up to $15 million per year. 8 Table of Contents We may be obligated to pay more costs in the future because, among other things, the FDA may determine that we are not fully compliant with the Consent Decree and Non-Compliance Letter and therefore impose penalties under the Consent Decree, and/or we may also be subject to future proceedings and litigation relating to the matters addressed in the Consent Decree, including, but not limited to, additional fines, penalties, other monetary remedies, and expansion of the terms of the Consent Decree.
Distribution BD’s products are marketed and distributed in the United States and internationally through independent distribution channels, as well as directly to hospitals and other healthcare related institutions by BD and independent sales representatives.
See further discussion of these risks in Item 1A. Risk Factors. Distribution BD’s products are marketed and distributed in the United States and internationally through independent distribution channels, as well as directly to hospitals and other healthcare related institutions by BD and independent sales representatives.
Research and Development BD conducts its research and development (“R&D”) activities at its operating units and across global enterprise centers of excellence located in the United States, India, China, Singapore and Ireland. The majority of BD’s R&D activities are conducted in North America. Outside North America, BD has a significant R&D presence in Greater Asia and Europe.
Risk Factors. 5 Table of Contents Research and Development BD conducts its research and development (“R&D”) activities at its operating units and across global enterprise centers of excellence located in the United States, India, China, Singapore and Ireland. The majority of BD’s R&D activities are conducted in North America.
To address all open recalls and ensure all devices at customer sites are running the most recent version of the BD Alaris™ Infusion System Software, all of the current BD Alaris™ Infusion System devices in the U.S. market will be remediated or replaced with the updated 510(k) cleared version over the next several years.
To address open recalls and ensure devices at customer sites are running a recent, cleared version of the BD Alaris™ Infusion System Software, BD Alaris™ Infusion System devices in the U.S. market are being remediated or replaced with the updated 510(k) cleared version, which we expect to be substantially complete over the next calendar year.
BD continuously assesses its sole sourced raw materials and components, and maintains business continuity plans with its suppliers. BD’s continuity plans may include securing secondary supply with alternate suppliers, qualification of alternate manufacturing facilities, maintaining contingency stock, internal development of supply and establishment of technology escrow accounts.
BD continuously assesses its sole sourced raw materials and components and maintains business continuity plans with its suppliers. BD’s continuity plans may include, but are not limited to, securing secondary supply with alternate suppliers, qualifying alternate manufacturing facilities, maintaining contingency stock, internally developing supply and establishing technology escrow accounts.
These agencies have the authority to take various administrative and legal actions against BD, such as product recalls, product seizures and other civil and criminal sanctions, for violations of applicable requirements. BD also undertakes voluntary compliance actions, such as voluntary recalls. In some cases, BD may determine that an identified product issue does not require a voluntary recall action.
These agencies have the authority to take various administrative and legal actions against BD, such as product recalls, product seizures and other civil and criminal sanctions, for violations of applicable requirements. BD also undertakes voluntary compliance actions, such as voluntary recalls.
BD received the Business Group on Health "Best Employers: Excellence in Health & Well-being Award" for its commitment to advancing employee well-being, and was recognized as a best place to work for disability inclusion for the sixth consecutive year.
We received the Business Group on Health “Best Employers: Excellence in Health & Well-being Award” for our commitment to advancing employee well-being and, were recognized once again as a best place to work for disability inclusion.
Advanced Patient Monitoring Advanced hemodynamic monitoring systems used to measure a patient's heart function and fluid status in surgical and intensive care settings. BD Life Sciences BD Life Sciences provides products for the safe collection and transport of diagnostics specimens, and instruments and reagent systems to detect a broad range of infectious diseases, healthcare-associated infections and cancers.
BD Life Sciences BD Life Sciences provides products for the safe collection and transport of diagnostics specimens, and instruments and reagent systems to detect a broad range of infectious diseases, healthcare-associated infections and cancers.
In addition, on April 13, 2023, the EPA published a Pesticide Registration Review; Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide (“PID”). The EPA has not yet finalized the PID, which regulates the use of ethylene oxide as a sterilant and is intended to mitigate any human health and environmental risks associated with its use.
In addition, on January 14, 2025, the EPA published a Notice of Availability for a Pesticide Registration Review; Interim Registration Review Decision for Ethylene Oxide (“ID”), which regulates the use of ethylene oxide as a sterilant and is intended to mitigate any human health and environmental risks associated with its use.
Compensation, Benefits and Well-being Our total rewards program is designed to attract and retain top talent and to incentivize performance aligned with our business strategy and values. We offer a comprehensive total rewards program aimed at promoting overall well-being in support of the varying health, home-life, and financial needs of our diverse and global associates.
We offer a comprehensive total rewards program aimed at promoting overall well-being in support of the varying health, home-life and financial needs of our global associates.
The providers that we serve are also evaluating changes in the healthcare reimbursement landscape and coverage elements leading to their own decision-making on what they will ultimately pay for various medical technologies or procedures, which could positively or negatively impact sales of BD products in any given country for any given product at any given time.
The providers that we serve are also evaluating changes in the healthcare reimbursement landscape and coverage elements leading to their own decision-making on what they will ultimately pay for various medical technologies or procedures, which could positively or negatively impact sales of BD products in any given country for any given product at any given time. 6 Table of Contents Vertical integration of health systems has created a concentrated market among commercial payers in the U.S. and there is an increased focus globally on payment policies that serve to control healthcare spending while also rewarding quality and patient outcomes.
BD is also licensed under domestic and foreign patents, patent applications, technology, trade secrets, know-how, copyrights and trademarks owned by others. In the aggregate, these intellectual property assets and licenses are of material importance to BD’s business.
Intellectual Property and Licenses BD owns significant intellectual property, including patents, patent applications, technology, trade secrets, know-how, copyrights and trademarks in the United States and other countries. BD is also licensed under domestic and foreign patents, patent applications, technology, trade secrets, know-how, copyrights and trademarks owned by others.
Human Capital Management At BD, our associates are guided by our purpose of advancing the world of health TM and The BD WAY, our cultural foundation that encompasses our core values, servant leadership expectations and the mindset we bring to our work. Our associates are empowered to contribute their unique ideas and experiences to fuel innovation and improve patient outcomes.
Our related human capital strategy is guided by our purpose of advancing the world of health TM , and THE BD WAY, our cultural foundation that encompasses our core values, leadership expectations and the mindset we bring to our work.
BD recognized a pre-tax gain on the sale of approximately $268 million, which was recorded as a component of Other operating expense (income), net in fiscal year 2023. The historical financial results for the Surgical Instrumentation platform have not been classified as a discontinued operation.
Surgical Instrumentation Platform In August 2023, BD completed the sale of the Interventional segment’s Surgical Instrumentation platform pursuant to a definitive agreement that was signed in June 2023. BD recognized a pre-tax gain on the sale of approximately $268 million, which was recorded as a component of Other operating expense (income), net in fiscal year 2023.
BD has manufacturing operations outside the United States in Bosnia and Herzegovina, Brazil, Canada, China, Dominican Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, the Netherlands, Singapore, Spain, and the United Kingdom.
BD has manufacturing operations outside the United States in Bosnia and Herzegovina, Brazil, Canada, China, Dominican Republic, France, Germany, Hungary, India, Ireland, Japan, Malaysia, Mexico, the Netherlands, Singapore, Spain, Switzerland, and the United Kingdom. Geographic information with respect to BD’s operations is included under the heading “Geographic Information” in Note 8 to the consolidated financial statements included in Item 8.
The primary customers served by BD Interventional are hospitals , ambulatory surgery centers, individ ual healthcare professionals, extended care facilities, alternate site facilities, and patients via our Homecare business.
BD Interventional BD Interventional provides vascular, urology, oncology and surgical specialty products that are intended to be used once and then discarded or are either temporarily or permanently implanted. The primary customers served by BD Interventional are hospitals , ambulatory surgery centers, individ ual healthcare professionals, extended care facilities, alternate site facilities, and patients via our Homecare business.
Should a regulator disagree with such a determination, the regulator may require BD to cease marketing of and recall the device until the issue has been corrected. In addition, BD may be required to seek an additional marketing authorization prior to marketing the corrected device.
In some cases, BD may determine that an identified product issue does not require a voluntary recall 7 Table of Contents action. Should a regulator disagree with such a determination, the regulator may require BD to cease marketing of and recall the device until the issue has been corrected.
Biosciences Fluorescence-activated cell sorters and analyzers; antibodies and kits for performing cell analysis; reagents for life science research; solutions for high-throughput single-cell gene and protein expression analysis; and clinical oncology, immunological (HIV) and transplantation diagnostic/monitoring reagents, analyzers and informatics. 2 Table of Contents BD Interventional BD Interventional provides vascular, urology, oncology and surgical specialty products that are intended to be used once and then discarded or are either temporarily or permanently implanted.
Biosciences Fluorescence-activated cell sorters and analyzers; antibodies and kits for performing cell analysis; reagents for life science research; solutions for high-throughput single-cell gene and protein expression analysis; and clinical oncology, immunological (HIV) and transplantation diagnostic/monitoring reagents, analyzers and informatics.
Additional information regarding this divestiture is contained in Note 2 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data, which is incorporated herein by reference. Spin-Off of Diabetes Care On April 1, 2022, BD completed the separation and distribution of Embecta Corp. (“Embecta”), formerly BD's Diabetes Care business, into a separate, publicly-traded company.
Spin-Off of Diabetes Care On April 1, 2022, BD completed the separation and distribution of Embecta Corp. (“Embecta”), formerly BD's Diabetes Care business, into a separate, publicly-traded company.
At a broader level, there is increased focus on the use and emission of ethylene oxide by the U.S. Environmental Protection Agency (“EPA”) and state environmental regulatory agencies. Additional regulatory requirements associated with the use and emission of ethylene oxide may be imposed in the future, either domestically or outside the U.S.
Additional regulatory requirements associated with the use and emission of ethylene oxide may be imposed in the future, either domestically or outside the United States.
BD continues to work with the FDA to generate additional clinical evidence and file 510(k)s as remaining commitments associated with the Warning Letter. As of September 30, 2024, BD has received seven FDA clearances.
Additionally, in December 2022, the FDA conducted a subsequent inspection of PAS (now Specimen Management) with no observations. We continue to work with the FDA to generate additional clinical evidence and file 510(k)s as remaining commitments associated with the Warning Letter. As of September 30, 2025, we have received eight FDA clearances.
BD also collaborates with certain universities, medical centers and other entities on R&D programs and retains individual consultants and partners to support its efforts in specialized fields. Intellectual Property and Licenses BD owns significant intellectual property, including patents, patent applications, technology, trade secrets, know-how, copyrights and trademarks in the United States and other countries.
Outside North America, BD has a significant R&D presence in Greater Asia and Europe. BD also collaborates with certain universities, medical centers and other entities on R&D programs and retains individual consultants and partners to support its efforts in specialized fields.
Companies generally have two years from the effective date to comply with the new requirements of the NESHAP. We are in the process of implementing certain changes to our facilities in accordance with NESHAP’s requirements, and such measures will require additional implementation and ongoing operational costs, including investments in certain new technologies.
While BD’s ethylene oxide sterilization facilities received this Presidential compliance exemption we continue to implement certain changes to our facilities in accordance with the revised NESHAP’s requirements, and such measures will require additional implementation and ongoing operational costs, including investments in certain new technologies.
This is part of a general trend toward increased regulation and enforcement activity within and outside the United States. In addition, the federal government has enacted the Sunshine Act provisions requiring BD to publicly report gifts and payments made to physicians and teaching hospitals.
In addition, BD may be required to seek an additional marketing authorization prior to marketing the corrected device. In addition, the federal government has enacted the Sunshine Act provisions requiring BD to publicly report gifts and payments made to physicians and teaching hospitals.
BD believes its activities in some countries outside the United States involve greater risk than its domestic business due to the factors cited herein. See further discussion of these risks in Item 1A. Risk Factors.
Financial Statements and Supplementary Data. For the most part, foreign economic conditions and exchange rate fluctuations have caused the profitability related to foreign revenues to fluctuate more than the profitability related to domestic revenues. BD believes its activities in some countries outside the United States involve greater risk than its domestic business due to the factors cited herein.
Business Segments BD’s operations consist of three worldwide business segments: BD Medical, BD Life Sciences and BD Interventional.
Business Segments As of September 30, 2025, BD’s operations consisted of three worldwide business segments: BD Medical, BD Life Sciences and BD Interventional. As further discussed in Note 8 to the consolidated financial statements contained in Item 8.
BD also is subject to various federal and state laws, and laws outside the United States, concerning healthcare fraud and abuse (including false claims laws and anti-kickback laws), global anti-corruption, transportation, safety and health, and customs and exports. Many of the agencies enforcing these laws have increased their enforcement activities with respect to medical device manufacturers in recent years.
Many of the agencies enforcing these laws have increased their enforcement activities with respect to medical device manufacturers in recent years. This is part of a general trend toward increased regulation and enforcement activity within and outside the United States. BD’s medical technology products and operations are subject to regulation by the U.S.
BD is also committed to compensating all associates fairly and equitably for their contributions to company performance. Aligned with our priority focus on pay equity, we regularly conduct comprehensive audits, internal and external analyses, salary benchmarking and bias assessments to identify and remedy unexplained disparities. 12 Table of Contents Available Information BD maintains a website at www.bd.com.
We are also committed to compensating all associates fairly and equitably for their contributions to our performance and as part of this commitment, we periodically conduct comprehensive audits, internal and external analyses, salary benchmarking and assessments to identify and remedy compensation disparities. 11 Table of Contents Culture of Inclusion and Philanthropy We believe our commitment to an inclusive workforce, coupled with our purpose and culture, allows us to better understand patient and customer needs and develop innovative technologies to meet those needs.
Information with respect to BD’s business segments is included in Notes 8, 11 and 16, respectively, to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data, and is incorporated herein by reference.
The historical financial results for the Surgical Instrumentation platform have not been classified as a discontinued operation. Additional information regarding this divestiture is contained in Note 2 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data, which is incorporated herein by reference.
Our associates possess a broad range of beliefs and experiences which have helped BD achieve our leadership position in the medical technology industry and the global marketplace. A key component of our journey to continually build a better BD is our commitment to global inclusion, diversity and equity (“ID&E”).
We take pride in building teams with diverse expertise and a deep understanding of the needs of varying populations to best serve our customers and patients worldwide. Our associates possess a broad range of beliefs and experiences that have helped us achieve a leading position in the medical technology industry and the overall global marketplace.
In connection with the receipt of the Dispensing Warning Letter, the Company recorded an accrual in the fourth quarter of fiscal year 2024. See Note 6 to the consolidated financial statements in “Item 8. Financial Statements and Supplementary Data.” It is possible that the amount of the Company’s liability could exceed its currently accrued amount.
In connection with the Dispensing Warning Letter, the Company recorded a liability for estimated future costs associated with certain actions required to respond to the Warning Letter and to address the non-conformities. See Note 6 to the consolidated financial statements in “Item 8.
Removed
As is further described below, on September 3, 2024, BD completed its acquisition of Edwards Lifesciences’ Critical Care product group (“Critical Care”), which was renamed as BD Advanced Patient Monitoring (“Advanced Patient Monitoring”) and operates as a separate organizational unit within the Company’s Medical segment.
Added
Financial Statements and Supplementary Data, effective October 1, 2025, BD reorganized its organizational units into five distinct, separately-managed segments, based on the nature of BD’s product and service offerings.
Removed
Financial Statements and Supplementary Data, which is incorporated herein by reference. Parata On July 18, 2022, BD completed the acquisition of Parata Systems (“Parata”), an innovative provider of pharmacy automation solutions. The fair value of consideration transferred in connection with the acquisition was $1.548 billion.
Added
BD’s new organizational structure is based upon the following five segments: Medical Essentials, Connected Care, BioPharma Systems, Interventional and Life Sciences, which remains a critical part of BD until the separation and combination of our Biosciences and Diagnostic Solutions business with Waters Corporation (“Waters”), as further discussed below, is completed.
Removed
Since the acquisition date, financial results for Parata's product offerings are being reported within results for the Medical segment’s Medication Management Solutions unit. Additional information regarding this acquisition is contained in Note 11 to the consolidated financial statements contained in Item 8.
Added
Advanced Patient Monitoring Advanced hemodynamic monitoring systems used to measure a patient's heart function and fluid status in surgical and intensive care settings, including noninvasive tissue oximetry systems; hemodynamic and tissue oximetry monitoring systems; pulmonary artery catheters and arterial pressure monitoring products and blood pressure measurement systems.
Removed
Financial Statements and Supplementary Data, which is incorporated herein by reference. 3 Table of Contents Divestitures Surgical Instrumentation Platform In August 2023, BD completed the sale of the Interventional segment’s Surgical Instrumentation platform pursuant to a definitive agreement that was signed in June 2023.
Added
Specimen Management Blood collection systems including safety-engineered wingsets, needles and blood collection tubes, arterial blood gas devices, urine collection kits, molecular research tubes, capillary collection technologies alongside associated products for patient identification,data capture, storage and transportation.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeOur ability to compete is also impacted by changing customer and patient preferences and requirements, including increased focus on products using materials of concern and demand for more sustainable products, and for products incorporating digital capabilities, including artificial intelligence, as well as changes in the ways healthcare services are delivered, such as the transition of more care from acute to non-acute settings and increased focus on chronic disease management.
Biggest changeWe face competition across all our product lines and in each market in which our products are sold on the basis of product features, clinical or economic outcomes, product quality, availability, price, services and other factors. 15 Table of Contents Our ability to compete is also impacted by changing customer and patient preferences and requirements, including changes in demand as a result of changes to U.S. federal and state policies (affecting products such as pharmaceuticals and vaccines), increased focus on products using materials of concern and demand for more sustainable products, and for products utilizing emerging technologies (such as AI), as well as changes in the ways healthcare services are delivered, such as the transition of more care from acute to non-acute settings and increased focus on chronic disease management.
Additionally, a number of factors, including U.S. relations with or among the governments of the foreign countries in which we operate, changes to international trade agreements and treaties, changes in tax laws and regulations, economic sanctions, export controls, restrictions on the ability to transfer capital across borders, tariffs and other increases in trade protectionism and barriers to market participation, or the weakening or loss of certain intellectual property rights in some countries, may affect our business, financial condition and results of operations.
Additionally, a number of factors, including U.S. relations with or among the governments of the foreign countries in which we operate, changes to international trade agreements and treaties, changes in tax laws and regulations, economic sanctions, export controls, restrictions on the ability to transfer capital across borders and other increases in trade protectionism and barriers to market participation, or the weakening or loss of certain intellectual property rights in some countries, may affect our business, financial condition and results of operations.
Governments in China and other countries continue to use various mechanisms to control healthcare expenditures, including increased use of competitive bidding and tenders, price regulation (such as volume-based procurement programs (“VoBP”)), government imposed payback provisions, and changes in reimbursement practices and policies on average selling prices for our products, which have unfavorably impacted our revenues and may continue to impact our results of operations in certain countries.
Globally, governments in China and other countries continue to use various mechanisms to control healthcare expenditures, including increased use of competitive bidding and tenders, price regulation (such as volume-based procurement programs (“VoBP”)), government imposed payback provisions, and changes in reimbursement practices and policies on average selling prices for our products, which have unfavorably impacted our revenues and may continue to impact our results of operations in certain countries.
Any alleged or actual violations of these laws may subject us to government investigations and significant criminal or civil sanctions and other liabilities, and negatively affect our reputation and could result in a material adverse effect on our business, results of operations, financial condition and cash flows. The medical technology industry is very competitive.
Any alleged or actual violations of these laws may subject us to government investigations and significant criminal or civil sanctions and other liabilities, and negatively affect our reputation which could result in a material adverse effect on our business, results of operations, financial condition and cash flows. The medical technology industry is very competitive.
Environmental laws, particularly with respect to climate change and the emission of greenhouse gases, are also becoming more stringent throughout the world, which may increase our costs of operations or necessitate closures of, or changes to, our manufacturing plants or processes or those of our suppliers, or result in liability to BD.
Environmental laws, particularly with respect to climate change and the emission of greenhouse gases, are also generally becoming more stringent throughout the world, which may increase our costs of operations or necessitate closures of, or changes to, our manufacturing plants or processes or those of our suppliers, or result in liability to BD.
Our ability to obtain and maintain regulatory approvals from the FDA or foreign regulators may be difficult and could increase the cost of compliance and impact our ability to market our products. Following the introduction of a product, these agencies also periodically review our manufacturing processes and product performance.
Our ability to obtain and maintain regulatory clearances or approvals from the FDA or foreign regulators may be difficult and could increase the cost of compliance and impact our ability to market our products. Following the introduction of a product, these agencies also periodically review our manufacturing processes and product performance.
Furthermore, currency exchange rates have been especially volatile in the recent past, and these currency fluctuations have affected, and may continue to affect, the reported value of our assets and liabilities, as well as our cash flows.
Furthermore, currency exchange rates have been volatile in the recent past, and these currency fluctuations have affected, and may continue to affect, the reported value of our assets and liabilities, as well as our cash flows.
Some of our products and systems collect personal, confidential or proprietary information regarding patients and patient therapy on behalf of our customers and some of our products are internet enabled or connect to our IT systems for maintenance and other purposes.
Additionally, some of our products and systems collect personal, confidential or proprietary information regarding patients and patient therapy on behalf of our customers and some of our products are internet enabled or connect to our IT systems for maintenance and other purposes.
Such non-compliance may also subject the Company to civil and criminal, monetary and non-monetary penalties, or other actions being taken with respect to products in the field. Marketing authorization and the time needed to secure such authorization is uncertain and we may not be able to obtain such authorization on the timeline or conditions we expect or at all.
Such non-compliance may also subject us to civil and criminal, monetary and non-monetary penalties, or other actions being taken with respect to products in the field. Marketing authorization and the time needed to secure such authorization is uncertain and we may not be able to obtain such authorization on the timeline or conditions we expect or at all.
We depend on cash on hand and cash flows from operations to make scheduled debt payments. However, our ability to generate sufficient cash flow from operations of the Company and to utilize other methods to make scheduled payments will depend on a range of economic, competitive and business factors, many of which are outside of our control.
We depend on cash on hand and cash flows from operations to make scheduled debt payments. However, our ability to generate sufficient cash flow from our operations and to utilize other methods to make scheduled payments will depend on a range of economic, competitive and business factors, many of which are outside of our control.
We are also subject to certain U.S. and foreign laws and regulations that restrict BD from transacting business with, or making investments in, certain countries, governments, entities and individuals subject to U.S. or foreign economic sanctions or export restrictions.
We are also subject to certain U.S. and foreign laws and regulations that restrict us from transacting business with, or making investments in, certain countries, governments, entities and individuals subject to U.S. or foreign economic sanctions or export restrictions.
In addition, competitors may seek to invalidate patents on our products or claim that our products infringe upon, misappropriate or otherwise violate their intellectual property, which could result in a loss of competitive advantage or the payment of significant legal fees, damage awards and past or future royalties, as well as injunctions against future sales of our products.
In addition, competitors may seek to invalidate patents on our products or claim that our products infringe upon, misappropriate or otherwise violate their intellectual property, which could result in a loss of competitive advantage or the payment of significant legal fees, damages and past or future royalties, as well as injunctions against future sales of our products.
As previously disclosed, on July 21, 2023, BD received 510(k) clearance from the FDA for its updated BD Alaris™ Infusion System, which enables both remediation and a return to market for the BD Alaris™ Infusion System.
As previously disclosed, on July 21, 2023, BD received 510(k) clearance from the FDA for its updated BD Alaris™ Infusion System, which enabled both remediation and a return to market for the BD Alaris™ Infusion System.
Our future growth is dependent in part upon the development of new products, and there can be no assurance that such products will be developed. A significant element of our strategy is to increase revenue growth by focusing on innovation and new product development. New product development requires significant investment in R&D, clinical trials and regulatory approvals.
Our future growth is dependent in part upon the development of new products, and there can be no assurance that such products will be developed. A significant element of our strategy is to increase revenue growth by continuing to focus on innovation and new product development. New product development requires significant investment in R&D, clinical trials and regulatory approvals.
Michael Feld 44 Executive Vice President and President, Life Sciences since August 2024; President of Hach (Veralto Corporation) from September 2023 to August 2024; Senior Vice President and General Manager of Danaher Corporation from June 2022 to September 2023; and President of Mammotome (Danaher Corporation) from January 2019 to September 2022.
Michael Feld 45 Executive Vice President and President, Life Sciences since August 2024; President of Hach (Veralto Corporation) from September 2023 to August 2024; Senior Vice President and General Manager of Danaher Corporation from June 2022 to September 2023; and President of Mammotome (Danaher Corporation) from January 2019 to September 2022.
While we have implemented policies and procedures relating to compliance with these laws, our international operations, which often involve customer relationships with foreign governments, create the risk that there may be unauthorized payments or offers of payments made by employees, consultants, sales agents or distributors.
While we have implemented policies, procedures and training related to compliance with these laws, our international operations, which often involve customer relationships with foreign governments, create the risk that there may be unauthorized payments or offers of payments made by employees, consultants, sales agents or distributors.
We continuously explore 19 Table of Contents alternative routes, transportation modes, and replenishment timings to preempt and mitigate associated risks, but no assurance can be given that these efforts will adequately address these challenges and disruptions. While we work with suppliers to ensure continuity of supply and service, no assurance can be given that these efforts will be successful.
We continuously explore alternative routes, transportation modes and replenishment timings to preempt and mitigate associated risks, but no assurance can be given that these efforts will adequately address these challenges and disruptions. While we work with suppliers to ensure continuity of supply and service, no assurance can be given that these efforts will be successful.
Extreme weather or other conditions, such as hurricanes, tornadoes, windstorms, wildfires or flooding, which may result from climate change could adversely impact our operations and supply chain, including the availability and cost of raw materials and components required for the operation of our business, and human capital issues for BD and companies within our supply chain.
Extreme weather or other conditions, such as hurricanes, tornadoes, windstorms, wildfires or flooding, which may result from climate change could adversely impact our operations and supply chain, including the availability and cost of raw materials and components required for the operation of our business, as well as result in human capital issues for us and companies within our supply chain.
While there has been a slight improvement in what had been an intensely competitive labor market, there continues to be pressure on skilled labor in certain markets.
While there has been an improvement in what had been an intensely competitive labor market, there continues to be pressure on skilled labor in certain markets.
Shana Neal 59 Executive Vice President and Chief People Officer since April 2022; Chief Human Resources Officer of Owens & Minor from April 2018 to March 2022.
Shana Neal 60 Executive Vice President and Chief People Officer since April 2022; Chief Human Resources Officer of Owens & Minor from April 2018 to March 2022.
Natural disasters, such as hurricanes, tornadoes, windstorms, earthquakes, wildfires, floods and other extreme weather events (including those caused by climate change), war, global health crises, terrorism, social or political unrest, labor disruptions and international conflicts and other events beyond our control, and actions taken by the U.S. and other governments or by our customers or suppliers in response to such events, could cause significant economic disruption and political and social instability in the U.S. and areas outside of the U.S. in which we operate.
Natural disasters, such as hurricanes, tornadoes, windstorms, earthquakes, wildfires, floods and other extreme weather events (including those caused by climate change), war, public health crises (such as pandemics and epidemics), terrorism, social or political unrest, labor disruptions and international conflicts and other events beyond our control, and actions taken by the U.S. and other governments, private health institutions or by our customers or suppliers in response to such events, could cause significant economic disruption and political and social instability in the U.S. and areas outside of the U.S. in which we operate.
Further, we expect that the breadth and complexity of our IT systems and infrastructure will increase as we expand our product offerings to utilize cloud technologies and potentially artificial intelligence, which present inherent enterprise technology risks, including those related to privacy, data protection and cybersecurity, that need to be managed.
Further, we expect that the breadth and complexity of our IT systems and infrastructure will increase as we expand our product offerings to utilize cloud technologies and AI, which present inherent enterprise technology risks, including those related to privacy, data protection and cybersecurity, that need to be managed.
A discussion of the financial impact of exchange rate fluctuations and the ways and extent to which we may attempt to address any impact is contained in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
A discussion of the financial impact of exchange rate fluctuations and the ways and extent to which we may attempt to address any impact is contained 17 Table of Contents in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Cost volatility could adversely affect our operations . Our results of operations could be negatively impacted by volatility in the cost of raw materials, components, labor, freight, energy and other production costs that, in turn, increases the costs of producing and distributing our products.
Our results of operations could be negatively impacted by volatility in the cost of raw materials, components, labor, duties, freight, energy and other production costs that, in turn, increases the costs of producing and distributing our products.
Governmental agencies may also impose new requirements regarding registration, including, but not limited to, labeling updates or changes to prohibited materials that require us to modify or re-register products already on the market or otherwise impact our ability 22 Table of Contents to market our products in those countries.
Governmental agencies may also impose new requirements regarding registration, including, but not limited to, labeling updates or changes to prohibited materials that require us to modify or re-register products already on the market or otherwise impact our ability to market our products in those countries.
In addition, acquisitions, and the integration of acquired companies into the Company’s existing and future IT systems and infrastructure, including with third-party vendors and processes, inherently presents cybersecurity risks, such as exposing us to vulnerabilities and threats that were previously unknown or unmanaged.
In addition, acquisitions and the integration of acquired companies into our existing and future IT systems and infrastructure, including with third-party vendors and processes, inherently present cybersecurity risks, such as exposing us to vulnerabilities and threats that were previously unknown or unmanaged.
In addition, the European Union (“EU”) has adopted the EU Medical Device Regulation (the “EU MDR”) and the In Vitro Diagnostic Regulation (the “EU IVDR”), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evidence requirements, quality systems and post-market surveillance.
In addition, the European Union (“EU”) has adopted the EU Medical Device Regulation (Regulation (EU) 2017/745, the “EU MDR”) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, the “EU IVDR”), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evidence, quality management systems and post-market surveillance.
Our operations are dependent in part on patents and other intellectual property assets. Many of our businesses rely on patent, trademark and other intellectual property assets. These intellectual property assets, in the aggregate, are of material importance to our business. We can lose the protection afforded by these intellectual property assets through patent expirations, legal challenges or governmental action.
Many of our businesses rely on patent, trademark and other intellectual property assets. These intellectual property assets, in the aggregate, are of material importance to our business. We can lose the protection afforded by these intellectual property assets through patent expirations, legal challenges or governmental action.
In addition, changes in regulatory or market standards, including, without limitation, cybersecurity requirements, often require significant investment to maintain compliance to relevant standards. Our ability to remain competitive will depend on how well we meet these changing market and regulatory demands in terms of our product offerings and go-to-market approaches.
In addition, changes in regulatory or market standards, including, without limitation, data protection and cybersecurity requirements, often require significant investment for compliance. Our ability to remain competitive will depend on how well we meet these changing market and regulatory demands in terms of our product offerings and go-to-market approaches.
A substantial amount of our sales come from our operations outside the U.S., and we intend to continue to pursue growth opportunities in foreign markets, especially in emerging markets. Our foreign operations subject us to certain commercial, political and financial risks.
A substantial amount of our sales come from our operations outside the U.S., and we intend to continue to pursue growth opportunities in new and existing foreign markets. Our foreign operations subject us to certain commercial, political and financial risks.
If any facts, assumptions, representations, and undertakings from BD and Embecta regarding the past and future conduct of their respective businesses and other matters are incorrect or not otherwise satisfied, the spin-off may not qualify for tax-free treatment, which could result in significant U.S. federal income tax liabilities for BD and its shareholders.
If any facts, assumptions, representations and undertakings from BD and Embecta regarding the past and future conduct of their respective businesses and other matters are incorrect or not 27 Table of Contents otherwise satisfied, the spin-off may not qualify for tax-free treatment, which could result in significant U.S. federal income tax liabilities for us and our shareholders.
Patents attained by competitors, particularly as patents on our products expire, may also adversely affect our competitive position. Competitors may design around our intellectual property to develop competing technologies and products without infringing our intellectual property rights.
Patents attained by competitors, particularly as patents on our products expire, may also adversely affect our competitive position. Competitors may design around our intellectual property to develop competing 25 Table of Contents technologies and products without infringing our intellectual property rights.
In addition, we rely on networks and services, including internet sites, cloud and software-as-a-service (“SaaS”) solutions, platform-as-a-service (“PaaS”) solutions, data hosting and processing facilities, artificial intelligence, tools and other hardware, software (including open-source software) and technical applications and platforms, including some 17 Table of Contents that are managed, hosted, provided and/or used by third-party vendors, to operate our business.
In addition, we rely on networks and services, including internet sites, cloud and software-as-a-service (“SaaS”) solutions, platform-as-a-service (“PaaS”) solutions, data hosting and processing facilities, AI, tools and other hardware, software (including open-source software) and technical applications and platforms, including some that are managed, hosted, provided and/or used by third-party vendors, to operate our business.
In particular, we purchase supplies of resins, which are oil-based components used to manufacture certain products, and any significant increase in resin costs, whether due to inflationary pressure, supply constraints, regulatory changes or otherwise , could adversely impact future operating results. Increases in oil prices can also increase our packaging and transportation costs.
In particular, we purchase supplies of resins, which are oil-based components used to manufacture certain products, and any significant increase in resin costs, whether due to inflationary pressure, increase in oil prices, supply constraints, regulatory changes or otherwise , could adversely impact future operating results.
The price and supply of these materials and components has been, and may in the future be, impacted or disrupted for reasons beyond our control, including supplier shutdowns, supplier capacity constraints, supplier insolvencies, labor disruptions or shortages, transportation delays, inflationary pricing pressures, work stoppages, extreme weather events, geopolitical developments, global economic uncertainty or downturns, sanctions and trade restrictions, and other governmental regulatory actions (such as in the area of materials of concern) and any such changes or disruptions could adversely affect our business, results of operations, financial condition and cash flows.
The price and supply of these materials and components has been, and may in the future be, impacted or disrupted for reasons beyond our control, including supplier shutdowns, supplier capacity constraints, supplier insolvencies, labor disruptions or shortages, transportation delays, inflationary pricing pressures, work stoppages, extreme weather events, tariffs and other geopolitical developments, global economic uncertainty or downturns, sanctions and trade restrictions and other governmental regulatory actions or inactions (such as in the area of materials of concern), including those taken as a result of a prolonged U.S. government shutdown, and any such changes or disruptions could adversely affect our business, results of operations, financial condition and cash flows.
Nontraditional entrants, such as technology companies, are also entering into the healthcare industry and some may have greater financial and other 14 Table of Contents resources than we do.
Nontraditional entrants, such as technology companies, are also entering into the healthcare industry and some may have greater financial and other resources than we do.
The agreements that govern our indebtedness contain various affirmative and negative covenants that may, subject to certain significant exceptions, restrict the ability of certain of our subsidiaries to incur debt and the ability of us and certain of our subsidiaries to, among other things, have liens on our property, and/or merge or consolidate with any other person or sell or convey certain of our assets to any one person, engage in certain transactions with affiliates and change the nature of our business.
The agreements that govern our indebtedness contain various affirmative and negative covenants that may, subject to certain significant exceptions, restrict the ability of certain of our subsidiaries to incur debt and the ability of us and certain of our subsidiaries to, among other things, have liens on our property, merge or consolidate with any other person or sell or convey certain of our assets to any one person.
Natural disasters, war and other events beyond our control could disrupt our business and adversely affect our future revenues and operating income.
Natural disasters, public health crises, war and other events beyond our control could disrupt our business and adversely affect our future revenues and operating income.
Additionally, the availability of EU notified body services certified to the new requirements is limited, which may delay the marketing approval for some of our products under the EU MDR.
Additionally, the availability of EU-notified body services certified under the new requirements is limited, which may delay the marketing approval for some of our products under these regulations.
The sale of our products and services, as well as access to them, depends, in part, on the healthcare funding landscape and how healthcare providers and facilities are reimbursed by public and private payers.
The sale of our products and services, as well as access to them, depends, in part, on the healthcare funding landscape, how healthcare providers and facilities are reimbursed by public and private payers and health insurance coverage levels and costs.
In addition, changes we have made, or may make in the future, to our products have been, or may in the future be, subject to U.S. or foreign regulatory review, including additional 510(k) clearance, PMA approval and other marketing authorizations (such as, but not limited to, with respect to BD Alaris TM pumps and related sets and BD Vacutainer TM ).
Further, changes we have made, or may make in the future, to our products have been, or may in the future be, subject to U.S. or foreign regulatory review, including additional 510(k) clearance, PMA approval, CE Mark and other marketing authorizations (such as, but not limited to, with respect to BD Alaris TM System and infusion sets and BD Vacutainer TM ).
In addition, our international operations are governed by the U.S. Foreign Corrupt Practices Act and similar foreign anti-corruption laws. Global enforcement of anti-corruption laws has increased substantially in recent years, with more enforcement proceedings by U.S. and foreign governmental agencies and the imposition of significant fines and penalties.
In addition, our international operations increase our compliance risk. For example, such international operations are governed by the U.S. Foreign Corrupt Practices Act and similar foreign anti-corruption laws. Global enforcement of anti-corruption and bribery laws has increased substantially in recent years, with more enforcement proceedings by foreign governmental agencies and the imposition of significant fines and penalties.
If any existing regulatory requirements or any such regulatory actions or rulemaking result in the suspension or interruption of sterilization operations at BD or at medical device sterilizers used by BD, or otherwise limit the availability of third-party sterilization capacity, this could interrupt or otherwise adversely impact production of certain of our products or lead to civil litigation or other claims against BD.
If any existing regulatory requirements or any such regulatory actions or rulemaking result in the suspension or interruption of our sterilization operations or at third-party medical device sterilizers we use, or otherwise limit the availability of third-party sterilization capacity, which could interrupt or otherwise adversely impact production of certain of our products or lead to civil litigation or other claims against us.
New laws or regulations adopted in response to climate change could also increase energy, conversion and transportation costs, as well as the costs of certain raw materials and components.
New laws or regulations adopted in response to climate change, and our sustainability efforts more generally, could also increase energy, conversion and transportation costs, as well as the costs of certain raw materials and components.
This increased regulation could require BD or sterilization service providers, including providers used by BD, to temporarily suspend operations to install additional emissions control technology, limit the use of ethylene oxide or take other actions, which would impact BD’s operations and further reduce the available capacity to sterilize medical devices and healthcare products, and could also result in additional costs.
This increased regulation could require us or our third-party sterilization service providers to temporarily suspend operations to install additional emissions control technology, limit the use of ethylene oxide or take other actions, which would impact our operations and further reduce the available capacity to sterilize medical devices and healthcare products, and could also result in additional costs.
The success of our operations outside the U.S. also depends, in part, on our ability to make necessary infrastructure enhancements to, among other things, our production facilities and sales and distribution networks and manage and staff widespread international operations. These and other factors may adversely impact our ability to pursue our growth strategy in these markets.
The success of our operations outside the U.S. also depends, in part, on our ability to make necessary infrastructure enhancements to, among other things, our production facilities and sales and distribution networks, and our strategic staffing plans required to support our international operations. These and other factors may adversely impact our ability to pursue our growth strategy in these markets.
We may make similar modifications or add additional features in the future that we believe do not require a new clearance or approval.
We may make similar modifications or add additional features in the future that we believe do not require a new marketing authorization.
There is no family relationship between any executive officer or director of BD. Name Age Position Thomas E. Polen 51 Chairman since April 2021; Chief Executive Officer since January 2020; President since April 2017; Chief Operating Officer from October 2018 to January 2020; and Executive Vice President and President - Medical Segment from October 2014 to April 2017.
There is no family relationship between any executive officer or director of BD. Name Age Position Thomas E. Polen 52 Chairman since April 2021; Chief Executive Officer since January 2020; President since April 2017; Chief Operating Officer from October 2018 to January 2020.
General global economic downturns and macroeconomic trends, including heightened inflation, capital market volatility, interest rate and currency rate fluctuations, economic slowdown or recession, have contributed to conditions that have impacted, and may continue to impact, demand for our products and services, or the prices we can charge for our products, disrupt aspects of our supply chain, impair our ability to produce our products, increase borrowing costs and exacerbate other risks that affect our business, financial condition and results of operations.
General global economic downturns and macroeconomic trends, including heightened inflation, capital market volatility (including volatility resulting from the imposition of (and changing policies around) tariffs and related countermeasures), import or export licensing requirements, interest rate and currency rate fluctuations, economic slowdown or recession, have contributed to conditions that have impacted, and may continue to impact, demand for our products and services, or the prices we can charge for our products, disrupt aspects of our supply chain, impair our ability to produce our products, increase borrowing costs and exacerbate other risks that affect our business, financial condition and results of operations.
These events could result in decreased demand for our products, adversely affect our manufacturing and distribution capabilities, or increase the costs for or cause interruptions in the supply of materials from our suppliers. 26 Table of Contents Information About our Executive Officers The following is a list of the executive officers of BD, their ages and all positions and offices held by each of them during the past five years.
These events could have a negative impact on the capital markets or result in decreased demand for our products, adversely affect our manufacturing and distribution capabilities or increase the costs for or cause interruptions in the supply of materials from our suppliers. 28 Table of Contents Information About our Executive Officers The following is a list of the executive officers of BD as of September 30, 2025, their ages and all positions and offices held by each of them during the past five years.
In addition to fluctuations in foreign currency exchange (discussed above), our business in these foreign markets is subject to changing political, social, and geopolitical conditions, such as the evolving situations in Ukraine, the Middle East and Asia.
In addition to fluctuations in foreign currency exchange (discussed above), our business in these foreign markets is subject to changing political, social, and geopolitical conditions, such as the continuation and/or escalation of the situation in Ukraine, the Middle East and Asia.
Cyberattacks continue to increase in frequency, sophistication and intensity, and are increasingly difficult to detect for periods of time, especially as they relate to attacks on third-party vendors. Such attacks are often carried out by motivated and highly skilled actors, who are increasingly well-resourced.
Cyberattacks continue to increase in frequency, sophistication and intensity, and are increasingly difficult to detect in real-time and may go undetected for long periods of time, especially as they relate to attacks on third-party vendors and those utilizing emerging technologies (such as AI). Such attacks are often carried out by motivated and highly skilled actors, who are increasingly well-resourced.
Our operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, occupational health and safety, antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), export control, product safety and efficacy, employment, labor, privacy and data protection, taxation, artificial intelligence and other areas.
Our operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, occupational health and safety, antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), export control, product safety and efficacy, employment, labor, privacy and data protection, taxation, the development, deployment and use of emerging technologies (such as AI) and other areas.
Manufacturing or design defects, component failures, unapproved or improper use of our products, or inadequate disclosure of risks or other information relating to the use of our products can lead to injury or other serious adverse events.
The design, manufacture and marketing of medical devices involve certain inherent risks. Manufacturing or design defects, component failures, unapproved or improper use of our products, or inadequate disclosure of risks or other information relating to the use of our products can lead to injury or other serious adverse events.
The foregoing could expose us to further risk of potential breaches, failures, interruptions and disruptions. While we are continuing to modernize our IT systems and infrastructure (such as hardware, software and operating systems), there are still technologies in operation that are more vulnerable to risk of failures, interruptions and disruptions.
While we are continuing to modernize our IT systems and infrastructure (such as hardware, software and operating systems), there are still legacy technologies in operation that are more vulnerable to risk of failures, interruptions and disruptions.
The revenues we report with respect to our operations outside the U.S. have been and may continue to be adversely affected by fluctuations in foreign currency exchange rates, which are caused by a number of factors, including changes in a country's political and economic policies and inflationary conditions.
The revenue we report with respect to our international operations has been, and may continue to be, affected by fluctuations in foreign currency exchange rates, which are caused by a number of factors, including changes in a country's political and economic policies, such as tariffs, and inflationary conditions.
To the extent we or our third-party providers are unable to sterilize our products, whether due to lack of capacity, availability of materials for sterilization (including cobalt), regulatory requirements or otherwise, we may be unable to transition sterilization to other sites or modalities in a timely or cost-effective manner, or at all, which could have an adverse impact on our operating results and financial condition.
To the extent we or our third-party providers are unable to sterilize our products, whether due to lack of capacity, availability of materials for sterilization (including cobalt), regulatory requirements or otherwise, we may be unable to transition sterilization to other sites or modalities in a timely or cost-effective manner, or at all, which could have an adverse impact on our operating results and financial condition. 20 Table of Contents At a broader level, there is continued focus on the use and emission of ethylene oxide by the EPA and state environmental regulatory agencies.
In addition, even if the Company believes it has meritorious defenses, from time to time the Company engages in settlement discussions and mediation and considers settlements taking into account various factors including, among other things, developments in such legal proceedings and the resulting risks and uncertainties.
In addition, even if we believe we have meritorious defenses, from time to time we engage in settlement discussions and mediation and consider settlements taking into account various factors including, among other things, developments in such legal proceedings and the resulting risks and uncertainties.
Failure to comply with these 25 Table of Contents covenants could result in an event of default, which, if not cured or waived, could accelerate our repayment obligations and could result in a default and acceleration under other agreements containing cross-default provisions. Under these circumstances, we might not have sufficient funds or other resources to satisfy all of our obligations.
Failure to comply with these covenants could result in an event of default, which, if not cured or waived, could accelerate our repayment obligations and could result in a default and acceleration under other agreements containing cross-default provisions.
Personal injuries relating to the use of our products can also result in 24 Table of Contents significant product liability claims being brought against us. In some circumstances, such adverse events could also cause delays in regulatory approval of new products or the imposition of post-market approval requirements.
Personal injuries relating to the use of our products can also result in significant product liability claims being brought against us. In some circumstances, such adverse events could also cause delays in regulatory approval of new products or the imposition of post-market approval requirements. Our operations are dependent in part on patents and other intellectual property assets.
Any such delays, or any failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to EU conformity requirements. 23 Table of Contents We are also subject to complex and frequently changing privacy and data protection laws, rules and regulations in the U.S. and a significant number of other countries where BD operates, regarding the collection, use, storage, security, transfer and other processing of personal data.
Any such delays, or any failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to EU conformity requirements. 24 Table of Contents We are also subject to complex and rapidly evolving privacy and data protection laws, regulations and standards which govern the collection, use, storage, transfer, sharing and processing of personal data (particularly sensitive health information) across the U.S. and a significant number of other countries where we operate.
Our ability to recruit and retain such talent will depend on a number of factors, including how BD’s compensation, benefits, work location, corporate culture and work environment compares with those offered by our competitors and other local employers.
Additionally, we need qualified managers and skilled employees with technical, manufacturing and distribution experience to operate our business successfully. Our ability to recruit and retain such talent will depend on a number of factors, including how BD’s compensation, benefits, work location, corporate culture and work environment compares with those offered by our competitors and other local employers.
The costs of raw materials, transportation, construction, services, and energy necessary for the production and distribution of our products continues to increase and be volatile. These prices may continue to fluctuate based on many factors beyond our control.
In addition to increased resin costs, any future increases in oil prices could also increase our packaging and transportation costs. The overall costs of raw materials, transportation, construction, services and energy necessary for the production and distribution of our products continue to increase and be volatile. These prices may continue to fluctuate based on many factors beyond our control.
Ezell 55 Executive Vice President, President of the Americas and Chief Marketing Officer since October 2020; Executive Vice President and Chief Marketing Officer from January 2020 to October 2020; Vice President, Connected Care and Insulins, Eli Lilly and Company from January 2019 to January 2020; and prior thereto, Vice President, Enterprise Capabilities and Solutions, Eli Lilly; Chief Marketing Officer, Elanco Animal Health; and Chief Customer Officer, Eli Lilly.
Ezell 56 Executive Vice President, President of the Americas and Chief Marketing Officer since October 2020; Executive Vice President and Chief Marketing Officer from January 2020 to October 2020; Vice President, Connected Care and Insulins, Eli Lilly and Company from January 2019 to January 2020.
Failure to meet stakeholder expectations or our own goals or commitments relating to sustainability or GHG emissions reductions, provide sustainable products or demonstrate GHG reductions could potentially result in loss of market share, reputational impacts, or an inability to attract and retain customers. Legal, Quality and Regulatory Risks We are subject to lawsuits.
Failure to meet customer, shareholder and other stakeholder expectations or our own commitments relating to sustainability or emissions reductions could potentially result in loss of market share, reputational impacts, or challenges in attracting and retaining customers. Legal, Quality and Regulatory Risks We are subject to lawsuits.
More stringent oversight by the FDA and other agencies in recent years has resulted in increased enforcement activity, which increases our compliance risk. Our CareFusion 303, Inc. subsidiary is operating under a Consent Decree that affects our BD Alaris™ infusion pump business in the U.S.
More stringent oversight by the FDA and other agencies can result in increased enforcement activity, which could increase our compliance risk. Our CareFusion 303, Inc. subsidiary is operating under an amended Consent Decree that affects our BD Alaris™ infusion pump business in the United States.
David Shan 54 Executive Vice President and Chief Integrated Supply Chain Officer since January 2023; Executive Vice President and Chief Quality Officer from March 2020 to August 2023; Senior Vice President, Global Supply Chain from May 2018 to August 2020. 27 Table of Contents Item 1B. Unresolved Staff Comments. None.
David Shan 55 Executive Vice President and Chief Integrated Supply Chain Officer since January 2023; Executive Vice President and Chief Quality Officer from March 2020 to August 2023; Senior Vice President, Global Supply Chain from May 2018 to August 2020.
The EU MDR has been fully operational for previously approved self-certified medical devices since May 2021. The application of the EU MDR has been extended until 2027 for certain devices considered higher-risk and to 2028 for other devices.
Although the EU MDR has been fully applicable for previously approved self-certified medical devices since May 2021, the application of the EU MDR has been extended until 2027 for certain devices considered higher-risk and to 2028 for other devices. This longer transition timeline applies only to devices that are transitioning to MDR and meet other specific conditions.
There can be no assurance that these sources will be adequate. If we are unable to service our indebtedness and fund our operations, we will be forced to reduce or delay capital expenditures, seek additional capital, sell assets or refinance our indebtedness.
If we are unable to service our indebtedness and fund our operations, through the raising of additional capital or otherwise, we will be forced to reduce or delay capital expenditures, seek additional capital, sell assets or refinance our indebtedness.
The enactment of additional laws and reporting requirements in the future or changes in the interpretation of existing laws or regulations, may increase our compliance costs or otherwise adversely impact our operations and financial performance. For example, the FDA’s increased oversight of laboratory developed tests may impact certain of our customers and, as a result, could affect our financial performance.
The enactment of additional laws and reporting requirements in the future or changes in the interpretation of existing laws or regulations, may increase our compliance costs or otherwise adversely impact our operations and financial performance.
We sell products to researchers at pharmaceutical and biotechnology companies, academic institutions, government laboratories and private foundations. Research and development spending of our customers can fluctuate based on spending priorities and general economic conditions. A number of these customers are also dependent for their funding upon grants from U.S. government agencies, such as the U.S.
Research and development spending of our customers can fluctuate based on spending priorities and general economic conditions and customers could reduce research and development spending and/or delay or avoid purchases of our products in response to economic factors. A number of these customers are also dependent for their funding upon grants from U.S. government agencies, such as the U.S.
In addition, currency exchange rates have been especially volatile in the recent past, and these currency fluctuations have affected, and may continue to affect, the reported value of our 13 Table of Contents assets and liabilities, as well as our cash flows.
Both domestic and international markets experienced inflationary pressures in fiscal year 2025 and we expect inflation to persist in the future. In addition, currency exchange rates have been especially volatile in the recent past, and these currency fluctuations have affected, and may continue to affect, the reported value of our assets and liabilities, as well as our cash flows.
While we have implemented cost containment measures, progressed selective price increases and taken other actions to mitigate these inflationary pressures in our supply chain, we may not be able to completely offset all the increases in our operational costs. A reduction or interruption in the supply of certain raw materials and components could adversely affect our operating results.
While we have implemented cost containment measures, progressed selective price increases and taken other actions to mitigate these inflationary pressures in our supply chain, we may not be able to completely offset all the increases in our operational costs. 21 Table of Contents Climate change and related sustainability efforts, or legal, regulatory or market measures to address these efforts, could adversely affect our business, financial condition or results of operations.
Michael Garrison 56 Executive Vice President and President, Medical Segment since September 2022; Worldwide President, BD Medication Management Solutions from March 2020 to September 2022; Worldwide President, BD Surgery from December 2018 to March 2020; Vice President and General Manager Worldwide Infusion Systems from July 2016 to December 2018.
Michael Garrison 57 Executive Vice President and President, Medical Segment since September 2022; Worldwide President, BD Medication Management Solutions from March 2020 to September 2022; Worldwide President, BD Surgery from December 2018 to March 2020. Roland Goette 63 Executive Vice President and President, EMEA since May 2017.
For example, the Organization for Economic Cooperation and Development (OECD) published Pillar Two Model Rules which impose a 15% minimum tax on income of large multinational enterprises in the jurisdictions in which they operate. Pillar Two is effective in some of the jurisdictions in which we operate beginning in fiscal year 2025.
The Organization for Economic Cooperation and Development published Pillar Two Model Rules, which impose a 15% global minimum tax, that became effective in some of the jurisdictions in which we operate in fiscal year 2025, and we continue to assess their impact.
Any exchange rate hedging activities we engage in may only offset a portion of the adverse financial impact resulting from unfavorable changes in foreign currency exchange rates.
Any foreign currency exchange rate hedging activities we engage in may only offset a portion of the financial impact resulting from changes in foreign currency exchange rates. We cannot predict with any certainty changes in foreign currency exchange rates or the degree to which we can effectively manage these fluctuations.
In addition, general economic conditions may impact the healthcare industry, including reductions in capital spending, changes in the delivery of healthcare services and increasing labor disputes or shortages, which could in turn affect demand for our products and services.
In addition, general economic conditions have adversely impacted, and may continue to adversely impact, the healthcare industry, including reductions in capital spending and U.S. federal funding and changes in the delivery of healthcare services, which have affected, and could in the future affect, demand for our products.
In particular, the shift of care from acute to non-acute settings may also place financial pressure on hospitals and broader healthcare systems that could result in less demand for our products and services. Cost containment efforts by governments and the private sector are also resulting in increased emphasis on products that reduce costs, improve clinical results and expand patient access.
In particular, the shift of care from acute to non-acute settings may also place financial pressure on hospitals and broader healthcare systems that could result in less demand for our products.
BD has business continuity plans in 20 Table of Contents place to mitigate the impact of any such disruption, although these plans may not be able to fully offset such impact, for the reasons noted above. See “Item 1.
We have business continuity plans in place to mitigate the impact of any such disruption, although these plans may not be able to fully offset such impact, for the reasons noted above. Cost volatility could adversely affect our operations .
There has been increased focus by federal, international, state and local regulatory and legislative bodies to combat and/or limit the effects of climate change through a variety of means, including regulating GHG emissions (and requirements to disclose climate-related risks and metrics, including GHG emissions), policies mandating or promoting the use of renewable or zero-carbon energy and sustainability initiatives, and additional taxes on fuel and energy.
There has also been shifting focus by federal, international, state and local regulatory and legislative bodies on combating and limiting climate change and to promote sustainability and related efforts through measures such as requiring disclosure of climate-related risks and metrics, including GHG emissions, conducting risk assessments on sustainability practices, adopting policies mandating or promoting the use of renewable or zero-carbon energy, implementing sustainability initiatives and imposing additional taxes on fuel and energy.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

20 edited+2 added−1 removed13 unchanged
Biggest changeOur cybersecurity risk management program is led by our Chief Information Security Officer (“CISO”), whose organization is responsible for identifying, assessing and managing risks from cybersecurity threats. Our CISO has over 20 years of experience leading information security, data risk management, application/system development and engineering teams at multiple large, global and publicly traded companies—including several Fortune 500 companies.
Biggest changeOur CISO has over 20 years of experience leading information security, data risk management, application/system development and engineering teams at multiple large, global and publicly traded companies—including several Fortune 500 companies. Our CISO holds Certified Information Systems Security Professional (“CISSP”), Certified Information Security Manager (“CISM”), Certified Information Privacy Professional (“CIPP”) and Security+ certifications and contributes to healthcare industry working groups.
On a quarterly basis, our CSRC receives information from our CISO regarding BD’s enterprise IT, manufacturing and distribution OT and product security programs, including the Company’s strategy and progress on key initiatives.
On a quarterly basis, our CSRC receives information from our CISO regarding our enterprise IT, manufacturing and distribution OT and product security programs, including the Company’s strategy and progress on key initiatives.
As part of integrating cybersecurity risk management into our ERM program, our ERC receives updates from our CIO and CISO on BD’s cybersecurity risk management strategy and program on a regular basis. 29 Table of Contents In addition to our CSRC and our ERC, we have established processes providing for the escalation of certain cybersecurity incidents and breaches.
As part of integrating cybersecurity risk management into our ERM program, our ERC receives updates from our CIO and CISO on BD’s cybersecurity risk management strategy and program on a regular basis. 31 Table of Contents In addition to our CSRC and our ERC, we have established processes providing for the escalation of certain cybersecurity incidents and breaches.
Our cybersecurity risk management program includes a documented incident response and critical incident management plan to identify, assess and manage the potential impact of cybersecurity threats or vulnerabilities and prioritize risk mitigation and/or remediation measures to safeguard BD products, manufacturing and distribution OT, enterprise IT and BD data.
Our cybersecurity risk management program includes a documented incident response and critical incident management plan to identify, assess and manage the potential impact of cybersecurity threats or vulnerabilities and prioritize risk mitigation and/or remediation measures to safeguard BD products, manufacturing and distribution OT, enterprise IT and BD data, including data of our customers.
Our CIO and CISO provide updates to the Audit Committee, and our VP of Product Security provides updates to the QRC, multiple times per year regarding BD’s cybersecurity risk management program, including the results of third-party assessments, progress towards cybersecurity goals and objectives, product cybersecurity matters, third-party risk management, regulatory compliance and other topics as needed.
Our CIO and CISO provide updates to the Audit Committee, and our VP of Product Security provides updates to the QRC, multiple times per year regarding our cybersecurity risk management program, including the results of third-party assessments, progress toward cybersecurity goals and objectives, product cybersecurity matters, third-party risk management, regulatory compliance and other topics as needed.
In addition, our management periodically conducts cybersecurity crisis simulations with the full Board to raise awareness of cybersecurity risks and enhance our incident preparedness. We also provide Board members the opportunity to take a cybersecurity training course through an external service provider.
In addition, our management periodically conducts cybersecurity crisis simulations and shares outcomes with the full Board to raise awareness of cybersecurity risks and enhance our incident response preparedness. We also provide Board members the opportunity to take a cybersecurity training course through an external service provider.
We also have processes by which certain cybersecurity incidents and breaches are escalated and reported to the Board of Directors or a Board committee, as appropriate, based on our management’s assessment of risk.
We also have processes by which certain cybersecurity incidents and breaches are escalated and reported to the Board of Directors or a Board committee, as appropriate, based on our management’s assessment of risk. 32 Table of Contents
We also have a committee consisting of senior members of our management, including our CIO and CISO, to evaluate cybersecurity incidents and breaches reported to the committee by our CISO on an ad-hoc basis for potential material impacts on BD, including its financial condition and results of operations, and assess BD’s public disclosure obligations.
We also have a committee consisting of senior members of our management, including our CIO and Chief Risk Officer, to evaluate cybersecurity incidents and breaches reported to the committee by our CISO on an ad-hoc basis for potential material impacts on our Company, including its financial condition, results of operations and cash flows, and to have a sub-committee of our disclosure committee assess our public disclosure obligations.
We strive to align BD Information Security policies and procedures with industry best practices, including the NIST Cybersecurity Framework, International Organization for Standardization (“ISO”)/International Electrotechnical Commission (IEC) 27001:2022 standards for information security, Underwriters Laboratories (“UL”) 2900-1 Cybersecurity Standard for Medical Devices, and U.S. Food and Drug Administration’s pre-market and post-market guidance for cybersecurity in medical devices.
We strive to align BD Information Security policies and procedures with industry best practices, including the NIST Cybersecurity Framework 2.0, International Organization for Standardization (“ISO”)/International Electrotechnical Commission (IEC) 27001:2022 standards for information security, Underwriters Laboratories (“UL”) 2900-1 Cybersecurity Standard for Medical Devices, and U.S.
Our Vice President, Research and Development, Product Security (“VP of Product Security”) also supports our cybersecurity risk management program by leading a team of product security professionals focused on implementing security by design, security in use and product end of life strategies across our portfolio of software-based products.
Our Vice President, Research and Development, Product Security (“VP of Product Security”) also supports our cybersecurity risk management program by leading a team of product security professionals focused on cybersecurity across the product lifecycle—including new product development, in-market products and end-of-life strategies—for our portfolio of software-based products.
Our third-party risk management program is aligned with NIST and ISO/IEC frameworks and is focused on continuous improvement through intelligence sharing with industry groups. 28 Table of Contents There can be no assurance that such measures will be sufficient to prevent, mitigate or remediate cybersecurity incidents or breaches.
Our third-party risk management program is assessed for maturity by an independent third party and is aligned with NIST and ISO/IEC frameworks. We remain focused on continuous improvement through intelligence sharing with industry groups. There can be no assurance that such measures will be sufficient to prevent, mitigate or remediate cybersecurity incidents or breaches.
Our VP of Product Security has more than 15 years of experience in the medical device industry, including at another publicly traded company managing product security. Our VP of Product Security has received training from the SANS Institute and contributes to healthcare industry groups such as the Health Sector Coordinating Counsel – Joint Cybersecurity Working Group.
Our VP of Product Security has nearly 20 years of experience in the medical device industry, including at another publicly traded company managing product security, and has also received training from the SANS Institute.
We also use tools to monitor unintentional sharing of personal, confidential and proprietary information.
Where permitted by law, we also use tools to monitor the sharing of personal, confidential and proprietary information to detect intentional or unintentional exfiltration from BD systems.
For further discussion of how our business, results of operations, and financial condition could be materially adversely affected by risks from cybersecurity threats, see “Item 1A, Risk Factors.” Governance The Board and its committees provide oversight of our ERM program, including our cybersecurity risk management program and the protection and resilience of BD products, manufacturing and distribution OT, enterprise IT and BD data.
The Board and its committees provide oversight of our ERM program, including our cybersecurity risk management program and the protection and resilience of BD products, manufacturing and distribution OT, enterprise IT and BD data.
In 2022, BD achieved ISO/IEC 27001:2022 certification at the enterprise level, demonstrating that BD’s Information Security Management System (ISMS) conforms to internationally recognized cybersecurity standards. In July 2024, BD engaged a third-party auditor to complete its second enterprise-level annual surveillance audit for ISO 27001, which determined that BD continues to meet these rigorous standards.
In 2025, BD engaged a third-party auditor to complete its third enterprise-level annual surveillance audit for ISO 27001, which determined that BD continues to meet these rigorous standards. We also incorporate cybersecurity risk management into our Enterprise Risk Management (“ERM”) program.
We also collaborate with government and industry leaders to gather and share cybersecurity threat intelligence. We provide mandatory annual cybersecurity awareness training for our 70,000+ associates, and we send phishing simulation emails monthly to all associates who use a BD email address and an assigned computing device.
We provide mandatory quarterly cybersecurity awareness training tailored to associates’ and contractors’ role-based responsibilities, and we send phishing simulation emails monthly to all users with a BD email address and an assigned computing device.
These policies and procedures establish processes for handling data, assets, systems and other technology resources to help protect BD products, manufacturing and distribution OT, enterprise IT and BD data. We also incorporate cybersecurity risk management into our Enterprise Risk Management (“ERM”) program.
These policies and procedures establish processes for handling data, assets, systems and other technology resources to help protect BD products, manufacturing and distribution OT, enterprise IT and BD data. In 2022, BD achieved ISO/IEC 27001:2022 certification at the enterprise level, demonstrating that BD’s Information Security Management System (ISMS) conforms to internationally recognized cybersecurity standards.
Our commitment to cybersecurity includes a total life cycle approach to protecting BD products, manufacturing and distribution OT, enterprise IT and BD data. Using various tools and techniques, we proactively monitor for suspicious activity and perform risk assessments (including independent third-party risk assessments), penetration testing and vulnerability scanning to identify potential threats and vulnerabilities.
Using various tools and techniques, we proactively monitor for suspicious activity and perform risk assessments, penetration testing and vulnerability scanning to identify potential threats and vulnerabilities. We also engage independent third parties to conduct cybersecurity assessments and attestations, and we collaborate with government and industry leaders, including industry working groups, to gather and share cybersecurity threat intelligence.
We incorporate cybersecurity risk management into our systems and processes, which we strive to align with multiple industry-leading cybersecurity standards, including the Joint Security Plan issued by the Health Sector Coordinating Council for BD products and guidelines issued by the National Institute of Standards and Technology (NIST) for our manufacturing and distribution OT and enterprise IT.
We incorporate cybersecurity risk management into our systems and processes through a comprehensive program guided by the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework 2.0. Our commitment to cybersecurity includes a total life cycle approach to protecting BD products, manufacturing and distribution OT, enterprise IT and BD data.
This program includes supplier cybersecurity vetting at the time of engagement, cybersecurity risk assessments and cybersecurity vulnerability monitoring.
This program includes supplier cybersecurity vetting at onboarding, and cybersecurity risk assessments, remediation, and cyber vulnerability monitoring while in-use, and deeper dive cyber risk assessments and security compliance 30 Table of Contents monitoring is in place for our highest-risk suppliers.
Removed
Our CISO holds Certified Information Systems Security Professional (“CISSP”), Certified Information Security Manager (“CISM”), Certified Information Privacy Professional (“CIPP”) and Security+ certifications and contributes to healthcare industry working groups, most recently serving as chair of the Health Information Sharing and Analysis Center (the “HISAC”) Information Security Risk Management Working Group.
Added
Food and Drug Administration’s pre-market and post-market guidance for cybersecurity in medical devices as required by law under Section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Healthcare Sector Coordinating Council (HSCC) Joint Security Plan (JSP) 2.0 is a recognized industry standard that informs how we manage the security of our products.
Added
For further discussion of how our business, results of operations, financial condition and cash flows could be materially adversely affected by risks from cybersecurity threats, see “Item 1A, Risk Factors.” Governance Our cybersecurity risk management program is led by our Chief Information Security Officer (“CISO”), whose organization is responsible for identifying, assessing and managing risks from cybersecurity threats.

Item 2. Properties

Properties — owned and leased real estate

3 edited+0 added−0 removed3 unchanged
Biggest changeThe international facilities are as follows: - Europe, Middle East, Africa , which includes facilities in Austria, Belgium, Bosnia, the Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Ghana, Greece, Hungary, Ireland, Israel, Italy, Kenya, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Arab Emirates. - Greater Asia , which includes facilities in Australia, Bangladesh, China, India, Indonesia, Japan, Malaysia, New Zealand, Pakistan, the Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam. - Latin America & Caribbean , which includes facilities in Argentina, Barbados, Brazil, Chile, Colombia, the Dominican Republic, Mexico, Peru and Uruguay. - Canada . 30 Table of Contents
Biggest changeThe international facilities are as follows: - Europe, Middle East, Africa , which includes facilities in Austria, Belgium, Bosnia, the Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Ghana, Greece, Hungary, Ireland, Israel, Italy, Kenya, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey and the United Arab Emirates. - Greater Asia , which includes facilities in Australia, Bangladesh, China, India, Indonesia, Japan, Malaysia, New Zealand, the Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam. - Latin America & Caribbean , which includes facilities in Argentina, Barbados, Brazil, Chile, Colombia, the Dominican Republic, Mexico, Peru and Uruguay. - Canada .
Item 2. Properties. BD’s executive offices are located in Franklin Lakes, New Jersey. As of September 30, 2024, BD owned or leased 302 facilities throughout the world, comprising approximately 26,555,343 square feet of manufacturing, warehousing, administrative, and research facilities.
Item 2. Properties. BD’s executive offices are located in Franklin Lakes, New Jersey. As of September 30, 2025, BD owned or leased 290 facilities throughout the world, comprising approximately 26,088,029 square feet of manufacturing, warehousing, administrative and research facilities.
The U.S. facilities, including those in Puerto Rico, comprise approximately 7,962,022 square feet of owned and 4,537,419 square feet of leased space. The international facilities comprise approximately 10,547,043 square feet of owned and 3,508,859 square feet of leased space. Sales offices and distribution centers included in the total square footage are also located throughout the world.
The U.S. facilities, including those in Puerto Rico, comprise approximately 8,032,762 square feet of owned and 4,415,212 square feet of leased space. The international facilities comprise approximately 10,324,954 square feet of owned and 3,315,101 square feet of leased space. Sales offices and distribution centers included in the total square footage are also located throughout the world.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings. Information with respect to certain legal proceedings is included in Note 6 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data, and is incorporated herein by reference. Item 4. Mine Safety Disclosures. Not applicable. 31 Table of Contents PART II
Biggest changeItem 3. Legal Proceedings. Information with respect to certain legal proceedings is included in Note 6 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data, and is incorporated herein by reference. Item 4. Mine Safety Disclosures. Not applicable. 33 Table of Contents PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 31 PART II 32 Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 32 Item 6. (Reserved) 32 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 33 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 57 Item 8.
Biggest changeItem 4. Mine Safety Disclosures 33 PART II 34 Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 34 Item 6. (Reserved) 34 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 35 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 60 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest change(2) Represents shares available under a repurchase program authorized by the Board of Directors on November 3, 2021, for 10 million shares, for which there is no expiration date.
Biggest change(3) Includes 2,148,356 shares remaining under the repurchase program authorized by the Board of Directors on November 3, 2021 and 10 million shares under a repurchase program authorized by the Board of Directors on January 28, 2025. There is no expiration date for either program.
The table below sets forth certain information regarding BD’s purchases of its common stock during the fiscal quarter ended September 30, 2024.
The table below sets forth certain information regarding BD’s purchases of its common stock during the fiscal quarter ended September 30, 2025.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. BD’s common stock is listed on the New York Stock Exchange under the symbol "BDX”. As of November 1, 2024, there were approximately 10,012 shareholders of record.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. BD’s common stock is listed on the New York Stock Exchange under the symbol “BDX”. As of October 31, 2025 , there were approximately 9,332 shareholders of record.
Period Total Number of Shares Purchased (1) Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (2) Maximum Number of Shares that May Yet be Purchased Under the Plans or Programs (2) July 1-31, 2024 1,164 $ 240.58 — 6,681,777 August 1-31, 2024 249 232.02 — 6,681,777 September 1-30, 2024 — — — 6,681,777 Total 1,413 $ 239.07 — 6,681,777 (1) Includes 1,413 shares purchased during the quarter in open market transactions by the trust relating to BD’s Deferred Compensation and Retirement Benefit Restoration Plan and 1996 Directors’ Deferral Plan.
Period Total Number of Shares Purchased (1) Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (2) Maximum Number of Shares that May Yet be Purchased Under the Plans or Programs (3) July 1-31, 2025 1,666 $ 178.76 — 13,426,039 August 1-31, 2025 1,277,885 195.68 1,277,683 12,148,356 September 1-30, 2025 — — — 12,148,356 Total 1,279,551 $ 195.66 1,277,683 12,148,356 (1) Includes 1,868 shares purchased during the quarter in open market transactions by the trust relating to BD’s Deferred Compensation and Retirement Benefit Restoration Plan and 1996 Directors’ Deferral Plan.
Added
(2) Represents shares purchased as further discussed in Note 4 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Added
In November 2025, the Company repurchased $250 million of its common stock through open market repurchases.

Item 7. Management's Discussion & Analysis

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

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Biggest changeThe Interventional segment’s revenue growth in 2023 primarily reflected the following: • Double-digit growth in global sales of the Surgery unit’s advanced repair and reconstruction platforms, as well as strong growth in sales of biosurgery products, was partially offset by a decline in revenues attributable to the sale of the Surgical Instrumentation platform in the fourth quarter. • Growth driven by global market penetration of the Peripheral Intervention unit’s peripheral vascular disease platform was partially offset by the impact of planned strategic portfolio exits. • Continued strong demand for the Urology and Critical Care unit’s PureWick TM offerings in the acute and alternative care settings. 40 Table of Contents Interventional segment operating income was as follows: (Millions of dollars) 2024 2023 2022 Interventional segment operating income $ 1,420 $ 1,217 $ 1,081 Segment operating income as % of Interventional revenues 28.5 % 25.7 % 24.2 % The Interventional segment's operating income as a percentage of revenues in 2024 and 2023, compared with the prior-year periods, reflected the following: • The Interventional segment’s higher gross profit margin in 2024 compared with 2023 primarily reflected favorable impacts from product mix and pricing. • The Interventional segment’s gross profit margin was flat in 2023 compared with 2022, which primarily reflected: ◦ Favorable impacts from price, continuous improvement projects, and a favorable comparison to the prior-year period, which was unfavorably impacted by certain purchase accounting adjustments; offset by ◦ Unfavorable impacts of higher raw material, labor and freight costs. • Lower selling and administrative expense, as well as research and development expense, as percentages of revenues in 2024 compared with 2023, and in 2023 compared with 2022, primarily reflected revenue growth that outpaced spending.
Biggest changeSelling and administrative expense as a percentage of revenues in 2024 was higher compared with 2023, which primarily reflected consistent spending on slower revenue growth. • Lower research and development expense as a percentage of revenues in 2025 compared with 2024, and in 2024 compared with 2023, primarily reflected the timing of project spending and product launches. 41 Table of Contents Interventional Segment The following summarizes Interventional revenues by organizational unit: 2025 vs. 2024 2024 vs. 2023 (Millions of dollars) 2025 2024 2023 Total Change Estimated FX Impact FXN Change Total Change Estimated FX Impact FXN Change Surgery $ 1,572 $ 1,492 $ 1,497 5.3 % 0.1 % 5.2 % (0.3) % (0.1) % (0.2) % Peripheral Intervention 1,996 1,933 1,865 3.3 % 0.1 % 3.2 % 3.7 % (0.4) % 4.1 % Urology and Critical Care 1,649 1,554 1,374 6.1 % 0.2 % 5.9 % 13.1 % (0.5) % 13.6 % Total Interventional revenues $ 5,217 $ 4,980 $ 4,736 4.8 % 0.2 % 4.6 % 5.1 % (0.4) % 5.5 % The Interventional segment’s revenue growth in 2025 primarily reflected the following: • Strong growth in sales of the Surgery unit’s advanced tissue regeneration portfolio, as well as the unit’s biosurgery and infection prevention products, partially offset by lower U.S. revenues attributable to legacy hernia products. • Strong growth in the Peripheral Intervention unit’s peripheral vascular disease portfolio that was particularly driven by sales of the unit’s Rotarex TM Atherectomy System, partially offset by an expected VoBP impact in China. • Continued double-digit growth in sales of the Urology and Critical Care unit’s PureWick TM offerings.
BD reports the results associated with Advanced Patient Monitoring’s product offerings as a separate organizational unit within our Medical segment and additional disclosures relating to this acquisition are provided in Notes 8, 11 and 16 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
BD reports the results associated with Advanced Patient Monitoring’s product offerings as a separate organizational unit within our Medical segment and additional disclosures relating to this acquisition are provided in Notes 11 and 16 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
We generally use the income approach to derive the fair value for impairment assessments. This approach calculates fair value by estimating future cash flows attributable to the assets and then discounting these cash flows to a present value using a risk-adjusted discount rate.
We generally use the income approach to derive the fair value for impairment assessments. This approach calculates fair value by estimating future cash flows attributable to the assets and then discounting these cash flows to present value using a risk-adjusted discount rate.
BD's management team aligns our operating model and investments with these key strategic pillars through continuous focus on the following underlying objectives: Grow • Accelerating innovation in smart devices, robotics, analytics, and artificial intelligence in order to enable new care settings, improve outcomes, streamline care workflows, and reduce costs within healthcare settings; • Focusing on a strong portfolio of core leading products, solutions and services that deliver greater benefits to patients, healthcare workers and researchers; • Investing in research and development that leads to and expands category leadership, as well as results in a robust product pipeline; • Leveraging our global scale in order to provide equitable access to affordable medical technologies around the world, including in under-resourced markets; • Supplementing our internal growth through strategic acquisitions in faster growing market segments; and • Focusing on cash management and an efficient capital structure in order to drive balance sheet productivity and strong shareholder returns.
BD's management team aligns our operating model and investments with these key strategic pillars through continuous focus on the following underlying objectives: Grow • Accelerating innovation in smart devices, robotics, analytics, and artificial intelligence in order to enable new care settings, improve outcomes, streamline care workflows, and reduce costs within healthcare settings; • Focusing on a strong portfolio of core leading products, solutions and services that deliver greater benefits to patients, healthcare workers and researchers; • Investing in research and development that leads to and expands category leadership, as well as results in a robust product pipeline; • Leveraging our global scale in order to provide equitable access to affordable medical technologies around the world, including in under-resourced markets; 35 Table of Contents • Supplementing our internal growth through strategic acquisitions in faster growing market segments; and • Focusing on cash management and an efficient capital structure in order to drive balance sheet productivity and strong shareholder returns.
We establish accruals to the extent future losses for individual matters are probable and reasonably estimable based upon our assessment of the likelihood of any adverse judgments or outcomes relative to these matters, as well as the potential ranges of probable losses.
We establish accruals to the extent losses for individual matters are probable and reasonably estimable based upon our assessment of the likelihood of any adverse judgments or outcomes relative to these matters, as well as the potential ranges of probable losses.
Simplify • Driving operating effectiveness and margin expansion through deployment of our BD Excellence program to increase factory productivity and asset efficiencies; 33 Table of Contents • Reducing complexity, increasing agility and improving customer experience by rationalizing our product portfolio, as well as by simplifying and optimizing our architecture and operating model; • Making strategic investments that prioritize a culture of quality and our quality management system to ensure we are a best-in-class, proactive quality-driven organization; • Enhancing customer experiences through the digitalization of internal processes and go-to-market approaches; • Collaborating across our supply chain to responsibly source materials and goods, as well as to reduce environmental impacts; and • Continuing our investments in an enterprise-wide renewable energy strategy to create more resilient operations.
Simplify • Driving operating effectiveness and margin expansion through deployment of our BD Excellence program to increase factory productivity and asset efficiencies; • Reducing complexity, increasing agility and improving customer experience by rationalizing our product portfolio, as well as by simplifying and optimizing our architecture and operating model; • Making strategic investments that prioritize a culture of quality and our quality management system to ensure we are a best-in-class, proactive quality-driven organization; • Enhancing customer experiences through the digitalization of internal processes and go-to-market approaches; • Collaborating across our supply chain to responsibly source materials and goods, as well as to reduce environmental impacts; and • Continuing our investments in an enterprise-wide renewable energy strategy to create more resilient operations.
In particular, there has been increased regulatory focus on the use and emission of ethylene oxide in sterilization processes, and additional regulatory requirements may be imposed in the future that could adversely impact BD or our third-party sterilization providers. • IT system disruptions, breaches or breakdowns, including through cyberattacks, ransom attacks or cyber-intrusion, which could impair our ability or that of our customers, suppliers and other business partners to conduct business, result in the loss of BD trade secrets or otherwise compromise sensitive information of BD or its customers, suppliers and other business partners, or of patients, including sensitive personal data, or result in efficacy or safety concerns for certain of our products, and result in investigations, legal proceedings, liability, expense or reputational damage or actions by regulatory bodies or civil litigation. • Difficulties inherent in product development, including the potential inability to successfully continue technological innovation, successfully complete clinical trials, obtain and maintain regulatory approvals and registrations in the U.S. and abroad, obtain intellectual property protection for our products, obtain coverage and adequate reimbursement for new products, or gain and maintain market approval of products, as well as the possibility of infringement claims by competitors with respect to patents or other intellectual property rights, all of which could preclude or delay commercialization of a product.
In particular, there has been increased regulatory focus on the use and emission of ethylene oxide in sterilization processes, and additional regulatory requirements may be imposed in the future that could adversely impact us or our third-party sterilization providers. • IT system disruptions, breaches or breakdowns, including through cyberattacks, ransom attacks or cyber-intrusion, which could impair our ability or that of our customers, suppliers and other business partners to conduct business, result in the loss of our trade secrets or otherwise compromise sensitive information 57 Table of Contents of BD or its customers, suppliers and other business partners, or of patients, including sensitive personal data, or result in efficacy or safety concerns for certain of our products, and result in investigations, legal proceedings, liability, expense or reputational damage or actions by regulatory bodies or civil litigation. • Difficulties inherent in product development, including the potential inability to successfully continue technological innovation, successfully complete clinical trials, obtain and maintain regulatory approvals, clearances and registrations in the U.S. and abroad, obtain intellectual property protection for our products, obtain coverage and adequate reimbursement for new products, or gain and maintain market approval of products, as well as the possibility of infringement claims by competitors with respect to patents or other intellectual property rights, all of which could preclude or delay commercialization of a product.
We also face currency exposure that arises from translating the results of our worldwide operations, including sales, to the U.S. dollar at exchange rates that have fluctuated from the beginning of a reporting period. We did not enter into contracts to hedge cash flows against these foreign currency impacts in fiscal year 2024 or 2023.
We also face currency exposure that arises from translating the results of our worldwide operations, including sales, to the U.S. dollar at exchange rates that have fluctuated from the beginning of a reporting period. We did not enter into contracts to hedge cash flows against these foreign currency impacts in fiscal year 2025 or 2024.
Given the uncertain nature of litigation generally, we are not able in all cases to reasonably estimate the amount or range of loss that could result from an unfavorable outcome of the litigation to which we are a party. When appropriate, accruals are developed with the consultation of outside counsel regarding the nature, timing and extent of each matter.
Given the uncertain nature of litigation generally, we are not able in all cases to reasonably estimate the amount or range of loss that could result from an unfavorable outcome of litigation in which the Company is a party. When appropriate, accruals are developed with the consultation of outside counsel regarding the nature, timing and extent of each matter.
Proceeds from this facility may be used for general corporate purposes and Becton Dickinson Euro Finance S.à r.l., an indirect, wholly owned finance subsidiary of BD, is authorized as an additional borrower under the credit facility. There were no borrowings outstanding under the revolving credit facility at September 30, 2024.
Proceeds from this facility may be used for general corporate purposes and Becton Dickinson Euro Finance S.à r.l., an indirect, wholly owned finance subsidiary of BD, is authorized as an additional borrower under the credit facility. There were no borrowings outstanding under the revolving credit facility at September 30, 2025.
Given the uncertain nature of litigation, we could incur charges in excess of any currently established accruals and, to the extent available, liability insurance. In the opinion of management, any such future charges, individually or in the aggregate, could have a material adverse effect on BD’s consolidated results of operations, financial condition and/or consolidated cash flows.
Given the uncertain nature of litigation, we could incur charges in excess of any currently established accruals and, to the extent available, liability insurance and any such future charges, individually or in the aggregate, could have a material adverse effect on BD’s consolidated results of operations, financial condition and/or consolidated cash flows.
As a result, we are permanently reinvested with respect to all of our historical foreign earnings as of September 30, 2024. Additional disclosures regarding our accounting for income taxes are provided in Note 17 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
As a result, we are permanently reinvested with respect to all of our historical foreign earnings as of September 30, 2025. Additional disclosures regarding our accounting for income taxes are provided in Note 17 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Our review of goodwill for each reporting unit compares the fair value of the reporting unit, estimated using an income approach, with its carrying value. Our annual goodwill impairment test performed on July 1, 2024 did not result in any impairment charges, as the fair value of each reporting unit exceeded its carrying value.
Our review of goodwill for each reporting unit compares the fair value of the reporting unit, estimated using an income approach, with its carrying value. Our annual goodwill impairment test performed on July 1, 2025 did not result in any impairment charges, as the fair value of each reporting unit exceeded its carrying value.
To calculate the pension expense in 2025, we will apply the individual spot rates along the yield curve that correspond with the timing of each future cash outflow for benefit payments in order to calculate interest cost and service cost.
To calculate the pension expense in 2026, we will apply the individual spot rates along the yield curve that correspond with the timing of each future cash outflow for benefit payments in order to calculate interest cost and service cost.
Additional disclosures regarding the method to be used in calculating the interest cost and service cost components of pension expense for 2025 are provided in Note 10 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Additional disclosures regarding the method to be used in calculating the interest cost and service cost components of pension expense for 2026 are provided in Note 10 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Investors should understand that it is not possible to predict or identify all such factors and should not consider this list to be a complete statement of all potential risks and uncertainties. 56 Table of Contents
Investors should understand that it is not possible to predict or identify all such factors and should not consider this list to be a complete statement of all potential risks and uncertainties. 59 Table of Contents
Cautionary Statement Regarding Forward-Looking Statements This report includes forward-looking statements within the meaning of the federal securities laws. BD and its representatives may also, from time to time, make certain forward-looking statements in publicly released materials, both written and oral, including statements contained in filings with the Securities and Exchange Commission, press releases, and our reports to shareholders.
Cautionary Statement Regarding Forward-Looking Statements This report includes forward-looking statements within the meaning of the federal securities laws. BD and its representatives may also, from time to time, make certain forward-looking statements in publicly released materials, both written and oral, including statements contained in filings with the SEC, press releases, and our reports to shareholders.
Financial Statements and Supplementary Data. 49 Table of Contents Access to Capital and Credit Ratings Our corporate credit ratings with the rating agencies Standard & Poor's Ratings Services (“S&P”), Moody's Investors Service (“Moody's”) and Fitch Ratings (“Fitch”) were as follows at September 30, 2024: S&P Moody’s Fitch Ratings: Senior Unsecured Debt BBB Baa2 BBB Commercial Paper A-2 P-2 F2 Outlook Stable Stable Stable Our corporate credit ratings at September 30, 2024 were unchanged compared with our ratings at September 30, 2023.
Financial Statements and Supplementary Data. 51 Table of Contents Access to Capital and Credit Ratings Our corporate credit ratings with the rating agencies Standard & Poor's Ratings Services (“S&P”), Moody's Investors Service (“Moody's”) and Fitch Ratings (“Fitch”) were as follows at September 30, 2025: S&P Moody’s Fitch Ratings: Senior Unsecured Debt BBB Baa2 BBB Commercial Paper A-2 P-2 F2 Outlook Stable Stable Stable Our corporate credit ratings at September 30, 2025 were unchanged compared with our ratings at September 30, 2024.
As exchange rates are an important factor in understanding period-to-period comparisons, we believe the presentation of results on a foreign currency-neutral basis in addition to reported results helps improve investors’ ability to understand our operating results and evaluate our performance in comparison to prior periods.
As exchange rates are an important factor in understanding period-to-period comparisons, we believe the presentation of results on a foreign currency-neutral basis, excluding translational foreign currency impacts, in addition to reported results helps improve investors’ ability to understand our operating results and evaluate our performance in comparison to prior periods.
The impact that changes in interest rates would have on interest rate derivatives outstanding at September 30, 2024 and 2023, as well as the effect that changes in interest rates would have on our earnings or cash flows over a one-year period, based upon our overall interest rate exposure, were estimated as follows: Increase (decrease) to fair value of interest rate derivatives outstanding Increase (decrease) to earnings or cash flows (Millions of dollars) 2024 2023 2024 2023 10% increase in interest rates $ (12) $ (3) $ 5 $ 2 10% decrease in interest rates $ 12 $ 2 $ (5) $ (2) Liquidity and Capital Resources Our strong financial position and cash flow performance have provided us with the capacity to accelerate our innovation pipeline through investments in research and development, as well as through strategic acquisitions.
The impact that changes in interest rates would have on interest rate derivatives outstanding at September 30, 2025 and 2024, as well as the effect that changes in interest rates would have on our earnings or cash flows over a one-year period, based upon our overall interest rate exposure, were estimated as follows: Increase (decrease) to fair value of interest rate derivatives outstanding Increase (decrease) to earnings or cash flows (Millions of dollars) 2025 2024 2025 2024 10% increase in interest rates $ (11) $ (12) $ (1) $ 5 10% decrease in interest rates $ 11 $ 12 $ 1 $ (5) Liquidity and Capital Resources Our strong financial position and cash flow performance have provided us with the capacity to accelerate our innovation pipeline through investments in research and development, as well as through strategic acquisitions.
Cash flows from continuing operating activities in 2023 reflected net income, adjusted by a change in operating assets and liabilities that was a net use of cash, which was significantly lower than the net use of cash in 2022 due to efforts in 2023 to optimize inventory levels.
Cash flows from continuing operating activities in 2023 reflected net income, adjusted by a change in operating assets and liabilities that was a net use of cash, which was significantly lower than the net use of cash 49 Table of Contents in 2022 due to efforts in 2023 to optimize inventory levels.
We were in compliance with these covenants, as applicable, as of September 30, 2024. • We are required to have a leverage coverage ratio of no more than: ◦ 4.25-to-1 as of the last day of each fiscal quarter following the closing of the credit facility; or ◦ 4.75-to-1 for the four full fiscal quarters following the consummation of a material acquisition.
We were in compliance with these covenants, as applicable, as of September 30, 2025. • We are required to have a leverage coverage ratio of no more than: ◦ 4.25-to-1 as of the last day of each fiscal quarter following the closing of the credit facility; or ◦ 4.75-to-1 for the five full fiscal quarters following the consummation of a material acquisition.
With respect to the foreign currency derivative instruments outstanding at September 30, 2024 and 2023, the impact that changes in the U.S. dollar would have on pre-tax earnings was estimated as follows: Increase (decrease) (Millions of dollars) 2024 2023 10% appreciation in U.S. dollar $ (143) $ (100) 10% depreciation in U.S. dollar $ 147 $ 100 These calculations do not reflect the impact of exchange gains or losses on the underlying transactions that would substantially offset the results of the derivative instruments. 46 Table of Contents Interest Rate Risk When managing interest rate exposures, we strive to achieve an appropriate balance between fixed and floating rate instruments.
With respect to the foreign currency derivative instruments outstanding at September 30, 2025 and 2024, the impact that changes in the U.S. dollar would have on pre-tax earnings was estimated as follows: Increase (decrease) (Millions of dollars) 2025 2024 10% appreciation in U.S. dollar $ (42) $ (143) 10% depreciation in U.S. dollar $ 68 $ 147 These calculations do not reflect the impact of exchange gains or losses on the underlying transactions that would substantially offset the results of the derivative instruments. 48 Table of Contents Interest Rate Risk When managing interest rate exposures, we strive to achieve an appropriate balance between fixed and floating rate instruments.
Proceeds from these programs may be used for working capital purposes and general corporate purposes, which may include acquisitions, share repurchases and repayments of debt. We had $400 million of commercial paper borrowings outstanding as of September 30, 2024. We have additional informal lines of credit outside the United States.
Proceeds from these programs may be used for working capital purposes and general corporate purposes, which may include acquisitions, share repurchases and repayments of debt. We had $855 million of commercial paper borrowings outstanding as of September 30, 2025. We have additional informal lines of credit outside the United States.
Contingencies We are involved, both as a plaintiff and a defendant, in various legal proceedings that arise in the ordinary course of business, including, without limitation, product liability and environmental matters, as further discussed in Note 6 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Contingencies We are involved, both as a plaintiff and a defendant, in various legal proceedings that arise in the ordinary course of business, including, without limitation, product liability and environmental matters in certain U.S. and international locations, as further discussed in Note 6 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Environmental laws, particularly with respect to the emission of greenhouse gases, are also becoming more stringent throughout the world, which may increase our costs of operations or necessitate changes in our manufacturing plants or processes or those of our suppliers, or result in liability to BD. • The effect of adverse media exposure or other publicity regarding BD’s business or operations, including the effect on BD’s reputation or demand for its products. • The effect of market fluctuations on the value of assets in BD’s pension plans and on actuarial interest rate and asset return assumptions, which could require BD to make additional contributions to the plans or increase our pension plan expense. • Our ability to obtain the anticipated benefits of restructuring programs, if any, that we may undertake.
New environmental laws, particularly with respect to the emission of greenhouse gases, may also increase our costs of operations or necessitate changes in our manufacturing plants or processes or those of our suppliers, or result in liability to us. • The effect of adverse media exposure or other publicity regarding our business or operations, including the effect on our reputation or demand for its products. • The effect of market fluctuations on the value of assets in our pension plans and on actuarial interest rate and asset return assumptions, which could require us to make additional contributions to the plans or increase our pension plan expense. • Our ability to obtain the anticipated benefits of restructuring programs, if any, that we may undertake.
Financial Statements and Supplementary Data. Other operating expense (income), net Other operating expense (income) in 2024, 2023 and 2022 included the following items which are further discussed in the Notes to the consolidated financial statements contained in Item 8.
Other operating expense (income), net Other operating expense (income) in 2025, 2024 and 2023 included the following items which are further discussed in the Notes to the consolidated financial statements contained in Item 8.
This increase reflected the following impacts: Increase (decrease) in current-year revenues Volume/other (a) 4.2 % Pricing 0.7 % Foreign currency impact (0.1) % Impact due to sale of Surgical Instrumentation platform (0.7) % Acquisition of Advanced Patient Monitoring 0.4 % Other (b) (0.3) % Increase in revenues from the prior-year period 4.2 % (a) Volume/other includes revenues attributable to products, services and licensing.
This increase reflected the following impacts: Increase (decrease) in current-year revenues Volume/other (a) 3.2 % Pricing (0.3) % Foreign currency impact 0.1 % Acquisition of Advanced Patient Monitoring 4.8 % Other (b) 0.4 % Increase in revenues from the prior-year period 8.2 % (a) Volume/other includes revenues attributable to products, services and licensing.
Higher interest income in 2024 compared with 2023, and in 2023 compared with 2022, primarily reflected higher overall interest rates and levels of cash on hand during the current-year periods, compared with the prior-year periods.
Higher interest income in 2024 compared with 2023 primarily reflected higher overall interest rates and levels of cash on hand during 2024, compared with the prior-year period.
Financial Statements and Supplementary Data. 48 Table of Contents Debt-Related Activities Certain measures relating to our total debt were as follows: 2024 2023 2022 Total debt (Millions of dollars) $ 20,110 $ 15,879 $ 16,065 Weighted average cost of total debt 3.4 % 3.0 % 2.8 % Total debt as a percentage of total capital (a) 42.9 % 37.2 % 37.3 % (a) Represents shareholders’ equity, net non-current deferred income tax liabilities, and debt.
Financial Statements and Supplementary Data. 50 Table of Contents Debt-Related Activities Certain measures relating to our total debt were as follows: 2025 2024 2023 Total debt (Millions of dollars) $ 19,181 $ 20,110 $ 15,879 Weighted average cost of total debt 3.4 % 3.4 % 3.0 % Total debt as a percentage of total capital (a) 42.6 % 42.9 % 37.2 % (a) Represents shareholders’ equity, net non-current deferred income tax liabilities, and debt.
Specifically for the U.S. plans, we will use a discount rate of 4.98% for 2025, which was based on an actuarially-determined, company-specific yield curve to measure liabilities as of the measurement date.
Specifically for the U.S. plans, we will use a discount rate of 5.25% for 2026, which was based on an actuarially-determined, company-specific yield curve to measure liabilities as of the measurement date.
Gross Profit Margin The comparisons of gross profit margins in 2024 and 2023 with the prior-year periods reflected the following impacts: 2024 2023 Gross profit margin % prior-year period 42.2 % 44.9 % Impact of purchase accounting adjustments and other specified items 3.2 % (2.5) % Operating performance 0.7 % 0.1 % Foreign currency impact (0.9) % (0.3) % Gross profit margin % current-year period 45.2 % 42.2 % The favorable impact on gross margin from specified items in 2024 compared with 2023 reflected a favorable comparison to specified items recorded in 2023, which included $653 million of charges recorded in the Medical segment to adjust the estimate of future product remediation costs, as noted above, partially offset by an unfavorable impact of $59 million due to a fair value step-up adjustment recorded by the Medical segment in 2024 relating to Advanced Patient Monitoring's inventory on the acquisition date.
Gross Profit Margin The comparisons of gross profit margins in 2025 and 2024 with the prior-year periods reflected the following impacts: 2025 2024 Gross profit margin % prior-year period 45.2 % 42.2 % Impact of purchase accounting adjustments and other specified items (1.1) % 3.2 % Operating performance 1.5 % 0.7 % Foreign currency impact (0.2) % (0.9) % Gross profit margin % current-year period 45.4 % 45.2 % The unfavorable impact on gross margin from specified items in 2025 compared with 2024 primarily reflected an impact of $336 million resulting from a fair value step-up adjustment relating to Advanced Patient Monitoring's inventory on the acquisition date, as well as the impact from amortization of intangibles acquired in the transaction which occurred on September 3, 2024. 45 Table of Contents The favorable impact on gross margin from specified items in 2024 compared with 2023 primarily reflected a favorable comparison to specified items recorded in 2023, which included $653 million of charges recorded in the Medical segment to adjust the estimate of future product remediation costs, partially offset by an unfavorable impact of $59 million due to a fair value step-up adjustment recorded by the Medical segment in 2024 relating to Advanced Patient Monitoring's inventory on the acquisition date.
Net Cash Flows from Continuing Investing Activities Capital expenditures Our investments in capital expenditures are focused on projects that enhance our cost structure and manufacturing capabilities, as well as support our BD 2025 strategy for growth and simplification. Capital expenditures of $725 million, $874 million and $973 million in 2024, 2023 and 2022, respectively, primarily related to manufacturing capacity expansions.
Net Cash Flows from Investing Activities Capital expenditures Our investments in capital expenditures are focused on projects that enhance our cost structure and manufacturing capabilities, as well as support the objectives of our growth strategy. Capital expenditures of $760 million, $725 million and $874 million in 2025, 2024 and 2023, respectively, primarily related to manufacturing capacity expansions.
The following table summarizes our consolidated statement of cash flows in 2024, 2023 and 2022: (Millions of dollars) 2024 2023 2022 Net cash provided by (used for) continuing operations Operating activities $ 3,844 $ 2,990 $ 2,471 Investing activities $ (5,514) $ (716) $ (3,220) Financing activities $ 2,087 $ (1,956) $ (736) Net Cash Flows from Continuing Operating Activities Cash flows from operating activities in 2024 was largely driven by our net income, adjusted by a change in operating assets and liabilities that was a net source of cash.
The following table summarizes our consolidated statement of cash flows in 2025, 2024 and 2023: (Millions of dollars) 2025 2024 2023 Net cash provided by (used for) operations Continuing operating activities $ 3,430 $ 3,844 $ 2,990 Investing activities $ (818) $ (5,514) $ (716) Financing activities $ (3,617) $ 2,087 $ (1,956) Net Cash Flows from Continuing Operating Activities Cash flows from operating activities in 2025 were largely driven by our net income, adjusted by a change in operating assets and liabilities that was a net use of cash.
Medical Segment The following summarizes Medical revenues by organizational unit: 2024 vs. 2023 2023 vs. 2022 (Millions of dollars) 2024 2023 2022 Total Change Estimated FX Impact FXN Change Total Change Estimated FX Impact FXN Change Medication Delivery Solutions $ 4,429 $ 4,293 $ 4,308 3.2 % (0.1) % 3.3 % (0.3) % (1.9) % 1.6 % Medication Management Solutions 3,297 2,980 2,533 10.7 % 0.2 % 10.5 % 17.6 % (1.0) % 18.6 % Pharmaceutical Systems 2,273 2,229 2,001 2.0 % 0.2 % 1.8 % 11.4 % (1.7) % 13.1 % Advanced Patient Monitoring 74 — — NM NM NM NM NM NM Total Medical revenues $ 10,074 $ 9,502 $ 8,841 6.0 % — % 6.0 % 7.5 % (1.6) % 9.1 % "NM" denotes that the percentage change is not meaningful.
Results of Operations Medical Segment The following summarizes Medical revenues by organizational unit: 2025 vs. 2024 2024 vs. 2023 (Millions of dollars) 2025 2024 2023 Total Change Estimated FX Impact FXN Change Total Change Estimated FX Impact FXN Change Medication Delivery Solutions $ 4,575 $ 4,429 $ 4,293 3.3 % (0.2) % 3.5 % 3.2 % (0.1) % 3.3 % Medication Management Solutions 3,474 3,297 2,980 5.4 % 0.2 % 5.2 % 10.7 % 0.2 % 10.5 % Pharmaceutical Systems 2,324 2,273 2,229 2.2 % 0.6 % 1.6 % 2.0 % 0.2 % 1.8 % Advanced Patient Monitoring 1,082 74 — NM NM NM NM NM NM Total Medical revenues $ 11,456 $ 10,074 $ 9,502 13.7 % 0.1 % 13.6 % 6.0 % — % 6.0 % "NM" denotes that the percentage change is not meaningful.
The credit facility provides borrowings of up to $2.750 billion, with separate sub-limits of $100 million and $194 million for letters of credit and swingline loans, respectively. The expiration date of the credit facility, which was extended in July 2024, may be extended for up to one additional one-year period, subject to certain restrictions (including the consent of the lenders).
The credit facility provides borrowings of up to $2.750 billion, with separate sub-limits of $100 million and $236 million for letters of credit and swingline loans, respectively. The expiration date of the credit facility may be extended for up to two additional one-year periods, subject to certain restrictions (including the consent of the lenders).
Risk Factors in this report and our subsequent Quarterly Reports on Form 10-Q. • General global, regional or national economic downturns and macroeconomic trends, including heightened inflation, capital market volatility, interest rate and currency rate fluctuations, and economic slowdown or recession, that may result in unfavorable conditions that could negatively affect demand for our products and services, impact the prices we can charge for our products and services, disrupt our transportation networks or other aspects of our supply chain, impair our ability to produce our products, or increase borrowing costs. • The impact of inflation and disruptions in our global supply chain on BD and our suppliers (particularly sole-source suppliers and providers of sterilization services), including fluctuations in the cost and availability of oil-based resins and other raw materials, as well as certain components, used in the production or sterilization of our products, transportation constraints, disruptions and delays, product shortages, energy shortages or increased energy costs, labor shortages or disputes, and increased operating and labor costs. 53 Table of Contents • Conditions in international markets, including social and political conditions, geopolitical developments such as the continuation and/or escalation of the evolving situations in Ukraine, the Middle East and Asia, civil unrest, political conflict, terrorist activity, governmental changes, restrictions on the ability to transfer capital across borders, economic sanctions, export controls, tariffs and other protectionist measures, barriers to market participation (such as local company and products preferences), difficulties in protecting and enforcing our intellectual property rights, and governmental expropriation of assets.
Risk Factors in this report and our subsequent Quarterly Reports on Form 10-Q. • General global, regional or national economic downturns and macroeconomic trends, including heightened inflation, capital market volatility (including volatility resulting from the imposition of (and changing policies around) tariffs and related countermeasures), import or export licensing requirements, other governmental restrictions, interest rate and currency rate fluctuations, and economic slowdown or recession, that may result in unfavorable conditions that could negatively affect demand for our products and services, impact the prices we can charge for our products and services, disrupt aspects of our supply chain, impair our ability to produce our products, or increase borrowing costs. • The impact of inflation, tariffs, and disruptions in our global supply chain on us and our suppliers (particularly sole-source suppliers and providers of sterilization services), including fluctuations in the cost and availability of oil-based resins and other raw materials, as well as certain components, used in the production or sterilization of our products, transportation constraints, disruptions and delays, product shortages, energy shortages or increased energy costs, labor shortages or disputes, and increased operating and labor costs. • The risks associated with the proposed combination of our Biosciences and Diagnostic Solutions business with Waters, including factors that could delay, prevent or otherwise adversely affect the 55 Table of Contents completion, timing or terms of the proposed transaction, or our ability to realize the expected benefits of the proposed transaction. • Conditions in international markets, including social and political conditions, geopolitical developments such as the continuation and/or escalation of the situation in Ukraine, the Middle East and Asia, civil unrest, political conflict, terrorist activity, governmental changes, restrictions on the ability to transfer capital across borders, economic sanctions, export controls, tariffs and other protectionist measures, barriers to market participation (such as local company and products preferences), difficulties in protecting and enforcing our intellectual property rights, and governmental expropriation of assets.
BD’s Spin-Off of Diabetes Care and Sale of Surgical Instrumentation Platform In August 2023, we completed the sale of the Interventional segment's Surgical Instrumentation platform. The historical financial results for this platform have not been classified as a discontinued operation. In April 2022, we completed the spin-off of our former Diabetes Care business as a separate publicly traded company.
BD’s Divestitures In August 2023, we completed the sale of the Interventional segment's Surgical Instrumentation platform. The historical financial results for this platform have not been classified as a discontinued operation. In April 2022, we completed the separation and distribution of Embecta Corp., formerly BD's Diabetes Care business, into a separate, publicly-traded company.
Specified Items Reflected in the financial results for 2024, 2023 and 2022 were the following specified items: (Millions of dollars) 2024 2023 2022 Integration costs (a) $ 23 $ 67 $ 68 Restructuring costs (a) 387 239 123 Transaction costs (b) 48 — — Financing costs (b) (8) — — Separation-related items (c) 13 14 20 Purchase accounting adjustments (d) 1,503 1,434 1,431 Product, litigation, and other items (e) 346 554 268 European regulatory initiative-related costs (f) 104 139 146 Impacts of debt extinguishment — — 24 Total specified items 2,416 2,448 2,082 Less: tax impact of specified items 297 399 366 After-tax impact of specified items $ 2,119 $ 2,050 $ 1,716 (a) Represents amounts associated with restructuring and integration activities which are recorded in Integration, restructuring and transaction expense and are further discussed below.
Specified Items Reflected in the financial results for 2025, 2024 and 2023 were the following specified items: (Millions of dollars) 2025 2024 2023 Integration costs (a) $ 127 $ 23 $ 67 Restructuring costs (a) 275 387 239 Transaction costs (b) 6 48 — Financing impacts (b) — (8) — Separation-related items (c) 97 13 14 Purchase accounting adjustments (d) 1,898 1,503 1,434 Product, litigation, and other items (e) 548 346 554 European regulatory initiative-related costs (f) — 104 139 Total specified items 2,951 2,416 2,448 Less: tax impact of specified items 473 297 399 After-tax impact of specified items $ 2,477 $ 2,119 $ 2,050 (a) Represents amounts associated with restructuring and acquisition integration activities which are recorded in Integration, restructuring and transaction expense and are further discussed below.
This may include decreases in the demand for our products, disruptions to our operations or the operations of our suppliers and customers, disruptions to our supply chain, or increases in transportation costs. • The risks associated with the qualification of the spin-off of our former Diabetes Care business as a tax-free transaction for U.S. federal income tax purposes. • Our ability to penetrate or expand our operations in emerging markets, which depends on local economic and political conditions, and how well we are able to make necessary infrastructure enhancements to production facilities and distribution networks. 55 Table of Contents • Our ability to recruit and retain key employees and the impact of labor conditions which could increase employee turnover or increase our labor and operating costs and negatively affect our ability to efficiently operate our business. • Fluctuations in the demand for products we sell to pharmaceutical companies that are used to manufacture, or are sold with, the products of such companies, as a result of funding constraints, consolidation or otherwise. • The impact of climate change, or legal, regulatory or market measures to address climate change, such as regulation of greenhouse gas emissions, zero-carbon energy and sustainability mandates and related disclosure requirements, and additional taxes on fuel and energy, and changing customer and other stakeholder preferences and requirements, such as those regarding the use of materials of concern, increased demand for products with lower environmental footprints, and for companies to set and demonstrate progress against sustainability goals and greenhouse gas reduction targets. • Natural disasters, including the impacts of hurricanes, tornadoes, windstorms, fires, earthquakes and floods and other extreme weather events, global health pandemics, war, terrorism, labor disruptions and international conflicts that could cause significant economic disruption and political and social instability, resulting in decreased demand for our products, adversely affect our manufacturing and distribution capabilities or cause interruptions in our supply chain. • Pending and potential future litigation or other proceedings asserting, and/or investigations concerning and/or subpoenas and requests seeking information with respect to, alleged violations of law (including in connection with federal and/or state healthcare programs (such as Medicare or Medicaid) and/or sales and marketing practices (such as investigative subpoenas and the civil investigative demands received by BD)), potential anti-corruption and related internal control violations under the Foreign Corrupt Practices Act, antitrust claims, securities law claims, environmental and product liability matters (including pending claims relating to ethlyene oxide, our hernia repair implant products, surgical continence and pelvic organ prolapse products for women, vena cava filter products and implantable ports, which involve, or could involve in the future, lawsuits seeking class action status or seeking to establish multi-district or other consolidated proceedings), data privacy breaches and patent infringement, and the availability or collectability of insurance relating to any such claims. • New or changing laws and regulations affecting our domestic and foreign operations, or changes in enforcement practices, including, without limitation, laws relating to sales practices, environmental protection and reporting, price controls, privacy, data protection, cybersecurity, artificial intelligence, employment, labor, and licensing and regulatory requirements for new products and products in the post-marketing phase.
Delays in obtaining necessary approvals or clearances from the FDA or other regulatory agencies due to government shutdowns or reductions in government staffing or changes in the regulatory process may also delay product launches and increase development costs. • The impact of business combinations or divestitures, including any volatility in earnings relating to acquisition-related costs, and our ability to successfully integrate any business we may acquire. • Risks relating to our overall level of indebtedness, including our ability to service our debt and refinance our indebtedness, which is dependent upon the capital markets and the overall macroeconomic environment and our financial condition at such time. • The risks associated with the qualification of the spin-off of our former Diabetes Care business as a tax-free transaction for U.S. federal income tax purposes. • Risks associated with our development, deployment and use of AI in our products and business operations. • Our ability to penetrate or expand our operations in emerging markets, which depends on local economic and political conditions, and how well we are able to make necessary infrastructure enhancements to production facilities and distribution networks. • Our ability to recruit and retain key employees and the impact of labor conditions which could increase employee turnover or increase our labor and operating costs and negatively affect our ability to efficiently operate our business. • Fluctuations in the demand for products we sell to pharmaceutical companies that are used to manufacture, or are sold with, the products of such companies, as a result of funding constraints, consolidation, the development of alternative therapies for disease states that may be delivered without a medical device, or otherwise. • The impact of climate change, legal, regulatory or market measures to address climate change, such as regulation of greenhouse gas emissions, zero-carbon energy and sustainability mandates and related disclosure requirements, and additional taxes on fuel and energy, or related sustainability efforts, and changing customer and other stakeholder preferences and requirements, such as those regarding the use of materials of concern, shifting demand for products with lower environmental footprints, and for progress toward sustainability goals and greenhouse gas reduction targets. • Natural disasters, including the impacts of hurricanes, tornadoes, windstorms, fires, earthquakes and floods and other extreme weather events, public health crises (such as pandemics and epidemics), war, terrorism, labor disruptions and international conflicts that could cause significant economic disruption and political and social instability, resulting in decreased demand for our products, adversely affect our manufacturing and distribution capabilities or cause interruptions in our supply chain, and our response may involve the implementation of measures which may not be successful. • Pending and potential future litigation or other proceedings asserting, and/or investigations concerning and/or subpoenas and requests seeking information with respect to, alleged violations of law (including in connection with federal and/or state healthcare programs (such as Medicare or Medicaid), government contracts and/or sales and marketing practices (such as investigative subpoenas and the civil 58 Table of Contents investigative demands received by us)), potential anti-corruption and related internal control violations under the Foreign Corrupt Practices Act, antitrust claims, securities law claims, environmental and product liability matters (including pending claims relating to ethylene oxide, our hernia repair implant products, surgical continence and pelvic organ prolapse products for women, vena cava filter products and implantable ports, which involve, or could involve in the future, lawsuits seeking class action status or seeking to establish multi-district or other consolidated proceedings), data privacy breaches and patent infringement, and the availability or collectability of insurance relating to any such claims. • New or changing laws and regulations affecting our domestic and foreign operations, or changes in enforcement practices, including, without limitation, laws relating to sales practices, healthcare, environmental protection and reporting, price controls, privacy, data protection, cybersecurity, AI, employment, labor and licensing and regulatory requirements for new products and products in the post-marketing phase.
These results should be considered in addition to, not as a substitute for, results reported in accordance with U.S. generally accepted accounting principles ("GAAP"). Results on a foreign currency-neutral basis, as we present them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with U.S. GAAP.
Results on a foreign currency-neutral basis, as we present them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with U.S. GAAP.
Additional disclosures regarding our debt instruments are provided in Note 16 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Cash and Short-term Investments At September 30, 2024, total worldwide cash and equivalents and short-term investments, including restricted cash, were $2.301 billion. More than half of these assets were held in the United States.
Additional disclosures regarding our debt instruments are provided in Note 16 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Cash and Short-term Investments At September 30, 2025, total worldwide cash and equivalents and short-term investments, including restricted cash, were $859 million and were primarily held outside of the United States.
Sensitivity to changes in key assumptions for our U.S. pension and other postretirement and postemployment plans are as follows: • Discount rate — A change of plus (minus) 25 basis points, with other assumptions held constant, would have an estimated $1 million favorable (unfavorable) impact on the total U.S. net pension and other postretirement and postemployment benefit plan costs.
We believe our discount rate and expected long-term rate of return on plan assets assumptions are appropriate based upon the above factors. 54 Table of Contents Sensitivity to changes in key assumptions for our U.S. pension and other postretirement and postemployment plans are as follows: • Discount rate — A change of plus (minus) 25 basis points, with other assumptions held constant, would have an estimated $3 million favorable (unfavorable) impact on the total U.S. net pension and other postretirement and postemployment benefit plan costs.
Income Taxes The income tax rates for continuing operations in 2024, 2023 and 2022 were as follows: 2024 2023 2022 Effective income tax rate for continuing operations 15.0 % 7.9 % 8.3 % Impact, in basis points, from specified items 150 (500) (500) The effective income tax rate for continuing operations in 2024 compared with 2023 primarily reflected the impact of more favorable discrete items recorded in 2023.
Income Taxes The income tax rates for continuing operations in 2025, 2024 and 2023 were as follows: 2025 2024 2023 Effective income tax rate for continuing operations 10.8 % 15.0 % 7.9 % Impact, in basis points, from specified items (320) 150 (500) The effective income tax rate for continuing operations in 2025 compared with 2024 primarily reflected more favorable discrete items recorded in 2025 and an unfavorable impact to the 2024 rate that was attributable to non-deductible costs.
Financial Statements and Supplementary Data. 34 Table of Contents Key Trends Affecting Results of Operations Our operations, supply chain, suppliers and customers are exposed to various global macroeconomic factors and we continually evaluate macroeconomic conditions to assess their potential impact to our operations and financial results.
Key Trends and Uncertainties Affecting Results of Operations Our operations, supply chain, suppliers and customers are exposed to various global macroeconomic factors and other risks which we continually evaluate to assess their potential impact to our operations and financial results.
Additional disclosures regarding these legislative and legal matters are provided in Notes 6 and 8 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Additional disclosures regarding this matter are provided in Note 6 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
To fund cash needs in the United States, we rely on ongoing cash flow from U.S. operations, access to capital markets and remittances from foreign subsidiaries of earnings that are not considered to be permanently reinvested. Financing Facilities We have a senior unsecured revolving credit facility in place which will expire in September 2027.
To fund cash needs in the United States, we rely on ongoing cash flow from U.S. operations, access to capital markets and remittances from foreign subsidiaries of earnings that are not considered to be permanently reinvested.
Operating performance in 2023 was unfavorably impacted by higher raw material, labor and freight costs. 43 Table of Contents Operating Expenses Operating expenses in 2024, 2023 and 2022 were as follows: Increase (decrease) in basis points (Millions of dollars) 2024 2023 2022 2024 vs. 2023 2023 vs. 2022 Selling and administrative expense $ 4,857 $ 4,719 $ 4,709 % of revenues 24.1 % 24.4 % 25.0 % (30) (60) Research and development expense $ 1,190 $ 1,237 $ 1,256 % of revenues 5.9 % 6.4 % 6.7 % (50) (30) Integration, restructuring and transaction expense $ 458 $ 313 $ 192 Other operating expense (income), net $ 222 $ (210) $ 37 Selling and administrative Selling and administrative expense as a percentage of revenues in 2024 was lower compared with 2023, which primarily reflected higher revenues and lower shipping costs in the current-year period, partially offset by higher selling costs.
Operating Expenses Operating expenses in 2025, 2024 and 2023 were as follows: Increase (decrease) in basis points (Millions of dollars) 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 Selling and administrative expense $ 5,278 $ 4,857 $ 4,719 % of revenues 24.2 % 24.1 % 24.4 % 10 (30) Research and development expense $ 1,265 $ 1,190 $ 1,237 % of revenues 5.8 % 5.9 % 6.4 % (10) (50) Integration, restructuring and transaction expense $ 408 $ 458 $ 313 Other operating expense (income), net $ 396 $ 222 $ (210) Selling and administrative Selling and administrative expense as a percentage of revenues in 2025 was flat compared with 2024, which primarily reflected higher revenues, offset by higher selling costs and higher administrative costs in the current-year period.
The Medical segment’s revenue growth in 2024 primarily reflected the following. • Strong global demand for the Medication Delivery Solutions unit’s Vascular Access Management portfolio, as well as strong U.S. demand for medication delivery products, partially offset by the impact of unfavorable market dynamics in China. • Double-digit growth in sales of infusion systems, as well as higher utilization of infusion sets within the Medication Management Solutions unit, partially offset by an unfavorable comparison to stronger placements of dispensing solutions in 2023. • Double-digit growth in sales of the Pharmaceutical Systems unit’s prefillable solutions in the biologic drug category, partially offset by customer order patterns relating to other drug categories. • Overall Medical segment revenue growth in 2024 also reflected the acquired Advanced Patient Monitoring unit’s sales beginning on September 3, 2024.
The Medical segment’s revenue growth in 2024 primarily reflected the following. • Strong global demand for the Medication Delivery Solutions unit’s Vascular Access Management portfolio, as well as strong U.S. demand for medication delivery products, partially offset by the impact of unfavorable market dynamics in China. • Double-digit growth in sales of infusion systems, as well as higher utilization of infusion sets within the Medication Management Solutions unit, partially offset by an unfavorable comparison to stronger placements of dispensing solutions in 2023. • Double-digit growth in sales of the Pharmaceutical Systems unit’s prefillable solutions in the biologic drug category, partially offset by customer order patterns relating to other drug categories. • Overall Medical segment revenue growth in 2024 also reflected the acquired Advanced Patient Monitoring unit’s sales beginning on September 3, 2024. 39 Table of Contents Medical segment operating income was as follows: (Millions of dollars) 2025 2024 (a) 2023 (a) Medical segment operating income $ 4,140 $ 3,583 $ 3,352 Segment operating income as % of Medical revenues 36.1 % 35.6 % 35.3 % (a) Prior-period segment income amounts have been recast to conform to the current year presentation, as further discussed in Note 8 to the consolidated financial statements contained in Item 8.
Financial Statements and Supplementary Data: 44 Table of Contents (Millions of dollars) 2024 2023 2022 Charge to accrue an estimated liability for the SEC investigation (see Note 6) $ 175 $ — $ — Other amounts recorded for legal matters (see Note 6) 79 — — Amounts recorded for product liabilities, including related defense costs (see Note 6) (36) 26 21 Separation-related items 13 14 20 Gain recognized on sale of business (see Note 2) — (268) — Other (9) 18 (4) Other operating expense (income), net $ 222 $ (210) $ 37 Net Interest Expense (Millions of dollars) 2024 2023 2022 Interest expense $ (528) $ (452) $ (398) Interest income 163 49 16 Net interest expense $ (364) $ (403) $ (382) Higher interest expense in 2024 compared with 2023 primarily reflected higher overall interest rates on debt outstanding, as well as higher total debt outstanding at September 30, 2024 compared with September 30, 2023, which reflected debt issued in our third quarter of fiscal year 2024 to fund the cash consideration payable upon our acquisition of Advanced Patient Monitoring.
Financial Statements and Supplementary Data: (Millions of dollars) 2025 2024 2023 Amounts recorded for product liability and certain other legal matters (see Note 6) $ 297 $ 43 $ 58 Charge to accrue an estimated liability for the SEC investigation (see Note 6) — 175 — Separation-related items (See Note 1) 97 13 14 Gain recognized on sale of business (see Note 2) — — (268) Other 3 (9) (14) Other operating expense (income), net $ 396 $ 222 $ (210) Net Interest Expense (Millions of dollars) 2025 2024 2023 Interest expense $ (613) $ (528) $ (452) Interest income 38 163 49 Net interest expense $ (575) $ (364) $ (403) Higher interest expense in 2025 compared with 2024, and in 2024 compared with 2023, primarily reflected higher total debt outstanding due to the issuance of debt in our third quarter of fiscal year 2024 to fund the cash consideration payable upon our acquisition of Advanced Patient Monitoring.
Emerging market revenues were as follows: 2024 vs. 2023 2023 vs. 2022 (Millions of dollars) 2024 2023 2022 Total Change Estimated FX Impact FXN Change Total Change Estimated FX Impact FXN Change Emerging markets $ 3,054 $ 2,966 $ 2,904 3.0 % (0.6) % 3.6 % 2.1 % (3.6) % 5.7 % Emerging market revenue growth in 2024 primarily reflected strong sales in Latin America and in countries other than China within Greater Asia, partially offset by a decline in China driven by unfavorable market dynamics, as further discussed above.
Emerging market revenues were as follows: 2025 vs. 2024 2024 vs. 2023 (Millions of dollars) 2025 2024 2023 Total Change Estimated FX Impact FXN Change Total Change Estimated FX Impact FXN Change Emerging markets $ 3,133 $ 3,054 $ 2,966 2.6 % (1.2) % 3.8 % 3.0 % (0.6) % 3.6 % Emerging market revenue growth in 2025 and 2024 primarily reflected strong sales in certain countries within Greater Asia and Latin America.
The net use of cash in 2023 primarily reflected lower levels of accounts payable and accrued expenses, as well as higher levels of trade receivables, partially offset by lower levels of prepaid expenses. Cash flows from continuing operating activities in 2022 reflected net income, adjusted by a change in operating assets and liabilities that was a net use of cash.
The net use of cash in 2023 primarily reflected lower levels of accounts payable and accrued expenses, as well as higher levels of trade receivables, partially offset by lower levels of prepaid expenses.
(see Note 2) $ — $ — $ 1,266 Net transfer of cash to Embecta upon spin-off $ — $ — $ (265) Additional disclosures regarding the equity and debt-related financing activities detailed above are provided in Notes 4 and 16 to the consolidated financial statements contained in Item 8.
Additional disclosures regarding the equity and debt-related financing activities detailed above are provided in Notes 4 and 16 to the consolidated financial statements contained in Item 8.
Net Cash Flows from Continuing Financing Activities Net cash from continuing financing activities in 2024, 2023 and 2022 included the following significant cash flows: (Millions of dollars) 2024 2023 2022 Cash inflow (outflow) Change in short-term debt $ 400 $ (230) $ 230 Proceeds from long-term debt $ 4,517 $ 1,662 $ 497 Payments of debt $ (1,142) $ (2,155) $ (805) Share repurchases $ (500) $ — $ (500) Dividends paid $ (1,100) $ (1,114) $ (1,082) Distribution from Embecta Corp.
Net Cash Flows from Financing Activities Net cash flows from financing activities in 2025, 2024 and 2023 included the following significant cash flows: (Millions of dollars) 2025 2024 2023 Cash inflow (outflow) Change in short-term debt $ 455 $ 400 $ (230) Proceeds from long-term debt $ — $ 4,517 $ 1,662 Payments of debt $ (1,789) $ (1,142) $ (2,155) Share repurchases $ (1,000) $ (500) $ — Dividends paid $ (1,196) $ (1,100) $ (1,114) In November 2025, we repurchased $250 million of our common stock through open market repurchases.
The historical results of the Diabetes Care business that was contributed in the spin-off were reflected as discontinued operations in our consolidated financial statements. Additional disclosures regarding the sale and spin-off are provided in Note 2 to the consolidated financial statements contained in Item 8.
Historical financial results have been reflected as discontinued operations in our consolidated financial statements. Additional disclosures regarding the sale and separation are provided in Note 2 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Life Sciences segment operating income was as follows: (Millions of dollars) 2024 2023 2022 Life Sciences segment operating income $ 1,595 $ 1,585 $ 1,710 Segment operating income as % of Life Sciences revenues 30.7 % 30.9 % 30.7 % The Life Sciences segment's operating income as a percentage of revenues in 2024 and 2023, compared with the prior-year periods, reflected the following: • The Life Sciences segment’s lower gross profit margin in 2024 compared with 2023 primarily reflected higher raw material and labor costs, as well as declines in respiratory illness-related revenues and unfavorable foreign currency translation, partially offset by lower manufacturing costs resulting from continuous improvement projects and other productivity initiatives. • The Life Sciences segment’s higher gross profit margin in fiscal year 2023 compared with 2022 primarily reflected the following: 39 Table of Contents ◦ Favorable impacts in 2023 from price and continuous improvement projects in our manufacturing facilities; partially offset by ◦ The decline in COVID-19-only testing revenues and a decline in licensing income compared with 2022, as well as higher raw material and labor costs in 2023. • Selling and administrative expense as a percentage of revenues in 2024 was higher compared with 2023, which primarily reflected lower costs in 2023.
The Life Sciences segment's operating income as a percentage of revenues in 2025 and 2024, compared with the prior-year periods, reflected the following: • The Life Sciences segment’s gross profit margin in 2025 was higher compared with 2024, which primarily reflected lower manufacturing costs resulting from continuous improvement projects, supply chain optimization and other productivity initiatives, partially offset by unfavorable impacts from higher labor costs, tariffs and foreign currency translation. • The Life Sciences segment’s lower gross profit margin in 2024 compared with 2023 primarily reflected higher raw material and labor costs, as well as declines in respiratory illness-related revenues and unfavorable foreign currency translation, partially offset by lower manufacturing costs resulting from the productivity initiatives noted above. • Selling and administrative expense as a percentage of revenues in 2025 was higher compared with 2024, which primarily reflected the current-period decline in revenues and higher shipping, selling, general and administrative costs.
(b) Represents transaction costs, which are recorded in Integration, restructuring and transaction expense , and financing impacts, which are recorded in Interest income and Interest expense , associated with the Advanced Patient Monitoring acquisition. (c) Represents costs recorded to Other operating expense (income), net and incurred in connection with the separation of BD's former Diabetes Care business.
(b) Represents transaction costs, which are recorded in Integration, restructuring and transaction expense , and financing impacts, which are recorded in Interest income and Interest expense , associated with the Advanced Patient Monitoring acquisition.
Foreign currency-neutral ("FXN") information compares results between periods as if exchange rates had remained constant period-over-period. We use results on a foreign currency-neutral basis as one measure to evaluate our performance. We calculate foreign currency-neutral percentages by converting our current-period local currency financial results using the prior-period foreign currency exchange rates and comparing these adjusted amounts to our current-period results.
We calculate translational foreign currency impacts by converting our current-period local currency financial results using the prior-period foreign currency exchange rates and comparing these adjusted amounts to our current-period results, which allows us to compare results between periods as if exchange rates had remained constant period-over-period.
Restructuring expense in 2024, 2023 and 2022 primarily included restructuring costs related to simplification and other cost-saving initiatives. Transaction costs in 2024 included legal, advisory and other costs, relating to our agreement to acquire Advanced Patient Monitoring. For further disclosures regarding the costs relating to restructurings, refer to Note 12 to the consolidated financial statements contained in Item 8.
Restructuring expense in 2025, 2024 and 2023 additionally included restructuring costs related to simplification and other cost-saving initiatives. For further disclosures regarding the costs 46 Table of Contents relating to restructurings, refer to Note 12 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
The effective income tax rate for continuing operations in 2023 compared with 2022 primarily reflected the impact of a remeasurement of deferred tax assets and liabilities upon the approval of a tax incentive. 45 Table of Contents Net Income and Diluted Earnings per Share from Continuing Operations Net income and diluted earnings per share from continuing operations in 2024, 2023 and 2022 were as follows: 2024 2023 2022 Net income from continuing operations (Millions of dollars) $ 1,705 $ 1,530 $ 1,635 Diluted earnings per share from continuing operations $ 5.86 $ 5.10 $ 5.38 Unfavorable impact-specified items $ 7.28 $ 7.11 $ 5.97 (Unfavorable) favorable impact-foreign currency impact $ (0.56) $ (0.37) $ 0.14 Financial Instrument Market Risk We selectively use financial instruments to manage market risk, primarily foreign currency exchange risk and interest rate risk relating to our ongoing business operations.
Net Income and Diluted Earnings per Share from Continuing Operations Net income and diluted earnings per share from continuing operations in 2025, 2024 and 2023 were as follows: 2025 2024 2023 Net income from continuing operations (Millions of dollars) $ 1,678 $ 1,705 $ 1,530 Diluted earnings per share from continuing operations $ 5.82 $ 5.86 $ 5.10 Unfavorable impact-specified items $ 8.59 $ 7.28 $ 7.11 Favorable (unfavorable) impact-foreign currency translation $ 0.02 $ (0.06) $ (0.31) Financial Instrument Market Risk We selectively use financial instruments to manage market risk, primarily foreign currency exchange risk and interest rate risk relating to our ongoing business operations.
BD 2025, our vehicle for value creation, is anchored in three key pillars: grow, simplify and empower.
Our strategy is anchored in three key pillars: grow, simplify and empower.
These favorable impacts to operating performance in 2024 were partially offset by higher raw material and labor costs and an unfavorable absorption impact of planned inventory reductions.
Operating performance in 2024 primarily reflected lower manufacturing costs from our productivity initiatives and a favorable impact from pricing, partially offset by higher raw material and labor costs and an unfavorable absorption impact of planned inventory reductions.
Interventional Segment The following summarizes Interventional revenues by organizational unit: 2024 vs. 2023 2023 vs. 2022 (Millions of dollars) 2024 2023 2022 Total Change Estimated FX Impact FXN Change Total Change Estimated FX Impact FXN Change Surgery $ 1,492 $ 1,497 $ 1,400 (0.3) % (0.1) % (0.2) % 6.9 % (1.3) % 8.2 % Peripheral Intervention 1,933 1,865 1,759 3.7 % (0.4) % 4.1 % 6.0 % (2.9) % 8.9 % Urology and Critical Care 1,554 1,374 1,305 13.1 % (0.5) % 13.6 % 5.3 % (1.8) % 7.1 % Total Interventional revenues $ 4,980 $ 4,736 $ 4,464 5.1 % (0.4) % 5.5 % 6.1 % (2.0) % 8.1 % The Interventional segment’s revenue growth in 2024 primarily reflected the following: • Strong growth in sales across the Surgery unit’s advanced repair and reconstruction platforms, as well as its infection prevention products; the prior-year period’s revenues included $140 million attributable to the unit’s former Surgical Instrumentation platform, which was sold in the fourth quarter of fiscal year 2023. • Double-digit growth attributable to the Peripheral Intervention unit’s peripheral vascular disease platform, partially offset by a decline in sales of our oncology products due to customer ordering patterns and market dynamics in China. • Double-digit growth in sales of the Urology and Critical Care unit’s PureWick TM offerings and current-year licensing revenue.
The Interventional segment’s revenue growth in 2024 primarily reflected the following: • Strong growth in sales across the Surgery unit’s advanced repair and reconstruction platforms, as well as its infection prevention products; the prior-year period’s revenues included $140 million attributable to the unit’s former Surgical Instrumentation platform, which was sold in the fourth quarter of fiscal year 2023. • Double-digit growth attributable to the Peripheral Intervention unit’s peripheral vascular disease platform, partially offset by a decline in sales of our oncology products due to customer ordering patterns and market dynamics in China. • Double-digit growth in sales of the Urology and Critical Care unit’s PureWick TM offerings and current-year licensing revenue. 42 Table of Contents Interventional segment operating income was as follows: (Millions of dollars) 2025 2024 (a) 2023 (a) Interventional segment operating income $ 2,253 $ 2,115 $ 1,939 Segment operating income as % of Interventional revenues 43.2 % 42.5 % 40.9 % (a) Prior-period segment income amounts have been recast to conform to the current year presentation, as further discussed in Note 8 to the consolidated financial statements contained in Item 8.
Higher interest expense in 2023 compared with 2022 was largely attributable to the higher levels of commercial paper borrowings outstanding throughout 2023 and higher overall interest rates on debt outstanding. Additional disclosures regarding our financing arrangements and debt instruments are provided in Note 16 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Additional disclosures regarding our financing arrangements and debt instruments are provided in Note 16 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Lower interest income in 2025 compared with 2024 primarily reflected lower levels of cash on hand and lower overall interest rates, compared with the prior-year period.
Geographic Revenues BD’s worldwide revenues by geography were as follows: 2024 vs. 2023 2023 vs. 2022 (Millions of dollars) 2024 2023 2022 Total Change Estimated FX Impact FXN Change Total Change Estimated FX Impact FXN Change United States $ 11,663 $ 11,113 $ 10,722 4.9 % — 4.9 % 3.7 % — 3.7 % International 8,515 8,258 8,148 3.1 % (0.2) % 3.3 % 1.4 % (4.2) % 5.6 % Total revenues $ 20,178 $ 19,372 $ 18,870 4.2 % (0.1) % 4.2 % 2.7 % (1.8) % 4.5 % U.S. revenue growth in 2024 reflected strong sales in the Medical segment’s Medication Delivery Solutions and Medication Management Solutions units, as well as in the Interventional segment’s Urology and Critical Care unit.
Geographic Revenues BD’s worldwide revenues by geography were as follows: 2025 vs. 2024 2024 vs. 2023 (Millions of dollars) 2025 2024 2023 Total Change Estimated FX Impact FXN Change Total Change Estimated FX Impact FXN Change United States $ 12,790 $ 11,663 $ 11,113 9.7 % — 9.7 % 4.9 % — 4.9 % International 9,049 8,515 8,258 6.3 % 0.4 % 5.9 % 3.1 % (0.2) % 3.3 % Total revenues $ 21,840 $ 20,178 $ 19,372 8.2 % 0.1 % 8.1 % 4.2 % (0.1) % 4.2 % U.S. revenue growth in 2025 was largely driven by the acquired Advanced Patient Monitoring unit’s sales.
We will use a long-term expected rate of return on 52 Table of Contents plan assets assumption of 7.5% for the U.S. pension plan in 2025. We believe our discount rate and expected long-term rate of return on plan assets assumptions are appropriate based upon the above factors.
We will use a long-term expected rate of return on plan assets assumption of 7.5% for the U.S. pension plan in 2026.
U.S. revenue growth in 2023 was particularly driven by strong sales in the Medical segment’s Medication Management Solutions and Pharmaceutical Systems units and in the Life Sciences segment’s Biosciences unit, as well as by strong sales in the Interventional segment’s Surgery and Urology and Critical Care units.
U.S. revenue growth also reflected strong sales in the Medical segment’s Medication Delivery Solutions and Medication Management Solutions units, as well as the Interventional segment’s Urology and Critical Care unit. U.S. revenue growth in 2025 was partially offset by a decline in the Life Sciences segment’s Diagnostic Solutions unit, as further discussed above.
We continue to pursue growth opportunities in emerging markets, which include the following geographic regions: Eastern Europe, the Middle East and Africa (collectively referred to below as “EMA”), as well as, Latin America and certain countries within Greater Asia. Strategic Objectives BD remains focused on delivering durable growth, creating shareholder value and making appropriate investments for the future.
We continue to pursue growth opportunities in emerging markets, which include the following geographic regions: Eastern Europe, the Middle East and Africa (collectively referred to below as “EMA”), as well as, Latin America and certain countries within Greater Asia. As further discussed in Note 8 to the consolidated financial statements contained in Item 8.
We have experienced, and may continue to experience, temporary shortages in supply of certain materials or components that are used in our products. The stable flow of global transport is critical to our operations and as such, events affecting the flow of logistics around the globe may adversely impact our supply chain and distribution channels.
The stable flow of global transport is critical to our operations and as such, events affecting the flow of logistics around the globe may adversely impact our supply chain and distribution channels. In general, major disruptions in the sourcing, manufacturing and distribution of our products could adversely impact our results of operations.
The majority of revenues relating to extended warranty contracts associated with certain 50 Table of Contents instruments and equipment is generally recognized within a few years whereas deferred revenue relating to software maintenance contracts is generally recognized over a longer period.
The majority of revenues relating to extended warranty contracts associated with certain instruments and equipment is generally recognized within a few years whereas deferred revenue relating to software maintenance contracts is generally recognized over a longer period. 52 Table of Contents Our agreements with customers within certain organizational units, primarily Medication Management Solutions, Diagnostic Solutions and Biosciences, contain multiple performance obligations that include both products and certain services noted above.
BD’s effective tax rate in any given period could be impacted if, upon resolution with taxing authorities, we prevailed in 51 Table of Contents positions for which reserves have been established, or we were required to pay amounts in excess of established reserves.
BD’s effective tax rate in any given period could be impacted if, upon resolution with taxing authorities, we prevailed in positions for which reserves have been established, or we were required to pay amounts in excess of established reserves. 53 Table of Contents We have reviewed our needs in the United States for possible repatriation of undistributed earnings of our foreign subsidiaries and we continue to invest foreign subsidiaries earnings outside of the United States to fund foreign investments or meet foreign working capital and property, plant and equipment expenditure needs.
The transaction price for these agreements is allocated to each performance obligation based upon its relative standalone selling price. Standalone selling price is the amount at which we would sell a promised good or service separately to a customer. We generally estimate standalone selling prices using list prices and a consideration of typical discounts offered to customers.
Determining whether products and services are considered distinct performance obligations that should be accounted for separately may require judgment. The transaction price for these agreements is allocated to each performance obligation based upon its relative standalone selling price. Standalone selling price is the amount at which we would sell a promised good or service separately to a customer.
We also consider trends related to certain key financial data, including gross profit margin, selling and administrative expense, investment in research and development, return on invested capital, and cash flows.
We also consider trends related to certain key financial data, including gross profit margin, selling and administrative expense, investment in research and development, return on invested capital, and cash flows. Proposed Combination of Our Biosciences and Diagnostic Solutions Business with Waters As noted above and as further discussed in Note 1 to the consolidated financial statements contained in Item 8.
Acquisitions Cash outflows for acquisitions in 2024 was attributable to the acquisition of Advanced Patient Monitoring in the fourth quarter of 2024.
Acquisitions Cash outflows for acquisitions in 2024 was attributable to the acquisition of Advanced Patient Monitoring in the fourth quarter of 2024. For further discussion, refer to Note 11 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
International revenue growth in 2024 also reflected the unfavorable impact of a $62 million accrual which resulted from recent developments relating to the Italian government medical device pay back legislation and substantially relates to years prior to the current fiscal year. Additional disclosures regarding this matter are provided in Note 6 to the consolidated financial statements contained in Item 8.
(b) Represents the impact of accruals recognized in fiscal year 2024 relating to the Italian government medical device pay back legislation, as well as another legal matter, and which substantially relate to years prior to fiscal year 2024. Additional disclosures regarding these legislative and legal matters are provided in Note 6 to the consolidated financial statements contained in Item 8.
Details of spending by segment are contained in Note 8 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Purchases of investments, net Cash outflows from continuing investing activities in 2024 included net purchases of investments, primarily in time deposits, of $421 million.
Details of spending by segment are contained in Note 8 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
The investment gains on deferred compensation plan assets were recorded to Other expense, net . Research and development Lower research and development expense as a percentage of revenues in 2024 compared with 2023, and in 2023 compared with 2022, primarily reflected the progression of current projects and revenue growth that outpaced project spending.
Financial Statements and Supplementary Data. Lower research and development expense as a percentage of revenues in 2024 compared with 2023, primarily reflected the progression of current projects and revenue growth that outpaced project spending. Spending in 2025, 2024 and 2023 reflected our continued commitment to invest in new products and platforms.
We evaluate our results of operations on both a reported and a foreign currency-neutral basis, which excludes the impact of fluctuations in foreign currency exchange rates.
The fiscal year 2025 impact of foreign currency on our revenues, which is primarily translational, is provided above. The translational impact on our earnings is provided further below. We evaluate our results of operations on both a reported and a foreign currency-neutral basis.
The amounts in 2024, 2023 and 2022 included net charges within Cost of products sold of $38 million, $653 million and $72 million, respectively, to record or adjust future costs estimated for product remediation efforts. The amounts in 2023 and 2022 also included pension settlement costs of $57 million and $73 million, respectively, which were recorded to Other expense, net.
Financial Statements and Supplementary Data. • The amounts in 2025, 2024 and 2023 included charges within Cost of products sold of $98 million, $38 million and $653 million, respectively, to record or adjust future costs estimated for product remediation efforts. • The amount in 2025 included a non-cash $30 million charge recorded within Research and development expense to write down certain assets in the Life Sciences segment, as further discussed below. • The amounts in 2025 and 2023 included pension settlement costs of $38 million and $57 million, respectively, which were recorded to Other expense, net, as further discussed in Note 10 to the consolidated financial statements contained in Item 8.
The use of alternative estimates could result in a different amount of revenue deferral. Our gross revenues are subject to a variety of deductions, including rebates. These deductions represent estimates of the related obligations and judgment is required when determining the impact on gross revenues for a reporting period.
These deductions represent estimates of the related obligations and require judgment when determining the impact on gross revenues for a reporting period.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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