BDX 10-K diff: FY 2024-09-30 → FY 2025-09-30
Paragraph-level diff of Risk Factors (Item 1A) and Management's Discussion & Analysis (Item 7).
Item 1A · Risk Factors
+82 paragraphs −78 paragraphs ~78 changed
FY 2024-09-30 (earlier)
Item 1A. Risk Factors.
An investment in BD involves a variety of risks and uncertainties. The following describes some of the material risks that could adversely affect BD’s business, financial condition, operating results or cash flows. We may also be adversely impacted by other risks not presently known to us or that we currently consider immaterial.
Business, Economic and Industry Risks
Global economic conditions, including inflation and supply chain disruptions, could continue to adversely affect our operations.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. 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. Both domestic and international markets experienced inflationary pressures in fiscal year 2024 and we expect inflation to persist in the future but at lower levels than in recent years. 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
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assets and liabilities, as well as our cash flows.
We have also experienced, and may continue to experience, challenges in our global supply chain, including shortages in supply, or disruptions in production and shipments, of certain materials or components used in our products, and related price increases. While to date, we have been able to manage the challenges associated with these delays and shortages without significant disruption to our business, no assurance can be given that these efforts will continue to be successful.Our international operations subject us to certain business 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 foreign markets, especially in emerging markets. Our foreign operations subject us to certain commercial, political and financial risks. 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. These conditions include instability resulting from war, terrorism, insurrections and civil unrest, political conflict, and changing economic conditions, such as inflation, deflation, interest rate volatility and credit availability. 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. Foreign regulatory requirements, including those related to the testing, authorization, and labeling of products and import or export licensing requirements, could affect the availability of our products in these markets. In addition to these broader market conditions, our operations may also be impacted by a variety of local factors, such as competition from local companies, local product preferences and requirements, changes in local healthcare payment systems and healthcare delivery systems, changes resulting from new political administrations, and labor force instability.
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.
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. 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. 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. 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.
We are a global company that faces significant competition from a wide range of existing competitors and new market entrants. These include large medical device companies with multiple product lines, some of which may have greater financial and other resources than we do, as well as firms which are more specialized than we are with respect to particular markets or product lines. Nontraditional entrants, such as technology companies, are also entering into the healthcare industry and some may have greater financial and other14
Table of Contentsresources than we do. We 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.
Our 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. 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 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.
The medical technology industry is also subject to rapid technological change, discovery and frequent product introductions. The development of new or improved products, processes or technologies by other companies that provide better features, pricing, clinical outcomes or economic value may render our current products or subsequently developed products obsolete or less competitive. In some instances, competitors, including pharmaceutical companies, also offer (or are attempting to develop) alternative therapies for disease states that may be delivered without a medical device. Lower cost producers have also created pricing pressure, particularly in developing markets.
The medical technology industry has also experienced a significant amount of consolidation, resulting in companies with greater scale and market presence than BD. Traditional distributors are also manufacturers of medical devices, providing another source of competition. In addition, healthcare systems and other providers are consolidating, resulting in greater purchasing power for these companies. As a result, competition among medical device suppliers to provide goods and services has increased. Group purchasing organizations and integrated health delivery networks have also served to concentrate purchasing decisions for some customers, which has led to downward pricing pressure for medical device suppliers. Further consolidation in the industry could intensify competition among medical device suppliers and exert additional pressure on the demand for and prices of our products.
We are subject to foreign currency exchange risk.
A substantial amount of our revenue is derived from international operations, and we anticipate that a significant portion of our future sales will continue to come from outside the U.S. 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. 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. 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. 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. We cannot predict with any certainty changes in foreign currency exchange rates or the degree to which we can effectively mitigate these risks.15
Table of ContentsMarket dynamics, changes in reimbursement practices and coverage policies and third-party payer cost containment measures could affect the demand for our products and the prices at which they are sold.
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. Coverage policies and reimbursement levels can vary across the payer community globally, regionally, and locally, and may affect which products customers purchase, the market acceptance rate for new technologies and the prices customers are willing to pay for those products in a particular jurisdiction. In addition, third-party payers are increasingly challenging the reimbursement models and prices charged for medical products and services. Any changes to the reimbursement landscape, or adverse decisions relating to our products by administrators of these systems could significantly reduce reimbursement for procedures using our products or result in denial of reimbursement for those products, which could adversely affect customer demand, or the price customers are willing to pay for such products. See “Third-Party Reimbursement” under “Item 1. Business.”
A global trend towards limiting growth of healthcare costs may also put industry-wide pressure on medical device or clinical diagnostic pricing. In the U.S., these include value-based purchasing and managed care arrangements. 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.
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. The results of our product development efforts may be affected by a number of factors, including our ability to anticipate customer needs, innovate and develop new products and technologies, successfully complete clinical trials, obtain regulatory approvals and reimbursement in the U.S. and abroad, manufacture products in a cost-effective manner, obtain appropriate intellectual property rights, and gain and maintain market acceptance of our products. In addition, patents attained by others can preclude or delay our commercialization of a product. There can be no assurance that any products now in development, or that we may seek to develop in the future, will achieve technological feasibility, obtain regulatory approval or gain market acceptance. If we are unable to develop and launch new products, our ability to maintain or expand our market position in the markets in which we participate may be negatively impacted. Even if we successfully develop new products or enhancements or new generations of existing products, they may be quickly rendered obsolete by changing customer preferences, changing industry or regulatory standards, or competitors’ innovations.
We are subject to risks associated with public health crises, such as pandemics and epidemics, which could have a material adverse effect on our business. The nature and extent of impacts from any such events are highly uncertain and unpredictable.
We are subject to risks associated with public health crises, such as pandemics and epidemics. Such events could result in preventative or protective measures or other actions by governments and private health institutions that could negatively impact local or global economic conditions and result in reductions in the demand for certain of our products, negatively impacting our business, financial condition and results of operations.
In addition, public health crises could result in significant volatility in our global supply chain network, including shortages in supply or disruptions or delays in shipments, as well as price increases, of certain materials or components used in our products and increases in transportation costs.16
Table of ContentsThe scope and duration of any future public health crisis, the pace at which government restrictions are imposed and lifted, the scope of additional actions taken to mitigate the spread of disease, global vaccination and booster rates, the speed and extent to which global markets and utilization rates for our products fully recover from the disruptions caused by such a public health crisis, and the impact of these factors on our business, financial condition and results of operations, will depend on future developments that are highly uncertain and cannot be predicted with confidence.
To the extent any such public health crises affect our operations and global economic conditions more generally, it may also have the effect of heightening many of the other risks described herein.Reductions in customers’ research budgets or government funding may adversely affect our business.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. National Institutes of Health, and similar agencies in other countries. The level of government funding of research and development is unpredictable. The availability of governmental research funding may be adversely affected by economic conditions and governmental spending reductions, particularly during periods of economic uncertainty. Any reduction or delay in governmental funding could cause our customers to delay or forgo purchases of our products.We need to attract and retain key employees to be competitive.Our ability to compete effectively depends upon our ability to attract and retain executives, key employees and other associates. Competition for experienced employees, particularly for persons with certain technical competencies in some geographies, can be a challenge. 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. 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. A sustained labor shortage or increased turnover rates within our employee base has led to, and may continue to lead to, increased costs, such as an increase in overtime necessary to meet demand and increased wages and benefit costs to attract and retain skilled employees, and could negatively affect our ability to efficiently operate our manufacturing and distribution facilities and overall business. If we cannot effectively recruit and retain qualified executives and skilled employees, we could encounter operational disruptions or other negative consequences to our business, financial condition or results of operations.Operational Risks
Cybersecurity incidents and breaches or breakdowns of our information and technology systems or infrastructure could have a material adverse effect on our operations.We rely on a large number of information and technology (“IT”) systems and related infrastructure, including services provided to us by third-party vendors to operate our business. We collect, use, store, transfer and otherwise process electronic information in our day-to-day operations, including personal, confidential, or proprietary information of BD and its customers, vendors and other business partners, and patients. 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. We also have products and systems that connect to the internet, hospital networks, electronic medical record systems or electronic health record systems. 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
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that are managed, hosted, provided and/or used by third-party vendors, to operate our business. 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. 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. In addition, while we continue to enhance business continuity and disaster recovery plans and strategies, there is no guarantee that such plans and strategies will be effective or account for all eventualities. We have experienced, and could in the future experience, the failure, interruption or disruption of the functionality of our IT systems and infrastructure, or those of third-party vendors upon which we rely, 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 personal, confidential or proprietary information of BD or its customers, suppliers and other business partners, or of patients, result in efficacy or safety concerns for certain of our products, result in reputational harm to our business and result in actions by regulatory bodies or civil litigation.
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. Our IT systems and infrastructure, as well as those of various third parties on which we rely, have experienced, and are likely to continue to experience, a variety of cyberattacks, including, but not limited to, unauthorized access, malicious code execution and/or phishing attacks, which has resulted, and could in the future result, in our and our customers’ personal, confidential or proprietary information being accessed, destroyed, lost, stolen or otherwise compromised and increased costs for cybersecurity measures or remediation. For example, through our cybersecurity monitoring tools and processes, we recently identified incidents of unauthorized activity on a portion of our IT systems, in which certain information relating to BD’s IT infrastructure and service credentials for certain BD Diagnostics Solutions, BD Pyxis TM , and Parata products utilized by laboratories, hospitals and pharmacies (the “Product Service Credentials”) were accessed and/or exfiltrated. After becoming aware of the incidents, BD terminated the unauthorized access, applied additional security measures, and is working with customers to update these Product Service Credentials. While an unauthorized party would have to penetrate a customer’s local network and, in some cases, may also need to be physically present at the instrument in order to use these Product Service Credentials, until these credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated systems or data. To date, we have not been made aware of any unauthorized use of these Product Service Credentials. As of the date of this filing, the incidents have not had, and we do not expect them to have, a material impact on BD’s overall business operations, financial condition or results of operations.
In addition, certain factors, such as growth through acquisitions, rapid technology evolution, including increased adoption of artificial intelligence, and geopolitical events, have increased cybersecurity risks. In this increasingly hostile environment, we, and our third-party vendors could experience, a loss, unauthorized access to or disclosure or other compromise of personal, confidential or proprietary information, including information regarding third parties, such as customers and patients, due to a number of causes, including, but not limited to, the exploitation of system vulnerabilities, cyberattacks, unauthorized access to our products, improper data handling, breakdowns of our IT systems and infrastructure or other cybersecurity incidents or breaches. These cybersecurity incidents and breaches could adversely affect our reputation, financial condition, results of operations or competitive position in the market and result in other significant negative consequences, including lost revenue, manufacturing challenges or disruption, diversion of management attention, litigation, regulatory action and damage to our relationships with vendors, business partners and customers.18
Table of ContentsUnauthorized tampering, adulteration or interference with our products, including through cyberattacks, may also create issues with product functionality that could result in a loss of data, risk to patient safety and product recalls or field actions, as well as impact our compliance with privacy, data protection and other laws and regulations and could result in reputational damage and actions by regulatory bodies or civil litigation.
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. While we attempt to mitigate these risks through due diligence, risk assessments and the implementation of cybersecurity controls and protocols during and after the acquisition process, there can be no assurance that such measures will be sufficient to prevent, mitigate or remediate cybersecurity incidents or breaches, which could have a material adverse effect on our business, financial condition and results of operations.
While we have made investments intended to address threats presented by cybersecurity incidents and breaches, continue to dedicate significant resources intended to protect our products and systems from cybersecurity incidents and breaches, and continue to work with government authorities and third-party vendors to detect and reduce the risk of future cybersecurity incidents and breaches, there can be no assurances that these protective measures will be sufficient to prevent cybersecurity incidents or breaches that could have a material adverse impact on our business.
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. 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. 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. 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. 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.
We purchase many different types of raw materials and components used in our products, some of which are not available from multiple sources. In addition, for quality assurance, cost-effectiveness and other reasons, certain raw materials and components are purchased from sole suppliers. 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. We have experienced, and may continue to experience, significant challenges to our global transportation channels and other aspects of our global supply chain network, including to the cost and availability of energy, raw materials and components due to shortages, labor strikes, and cost inflation. We continuously explore19
Table of Contentsalternative 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. In addition, due to regulatory requirements relating to the qualification of suppliers, we may not be able to establish additional or replacement sources on a timely basis or without excessive cost. The termination, reduction or interruption in supply of these raw materials and components could adversely impact our ability to manufacture and sell certain of our products, which could have an adverse impact on our business, financial condition and results of operations.
Interruption of our manufacturing or sterilization operations could adversely affect our business.
We have manufacturing sites all over the world. In some instances, however, the manufacturing of certain of our product lines is concentrated in one or a few of our plants. Interruption to our manufacturing operations resulting from system outages, cybersecurity incidents or breaches, weather or natural disasters, regulatory requirements, labor disruptions, equipment failure or other issues in our manufacturing process, could adversely affect our ability to manufacture our products. In some instances, we may not be able to transition manufacturing to other BD sites or a third party to replace the lost production. A significant interruption of our manufacturing operations could result in lost revenues and damage to our relationships with customers.
In addition, many of our products require sterilization prior to sale, and we utilize both BD facilities and third parties for this process. In some instances, only a few facilities are qualified under applicable regulations to conduct this sterilization. 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.At a broader level, there is increased focus on the use and emission of ethylene oxide by the EPA and state environmental regulatory agencies. Additional regulatory requirements associated with the use and emission of ethylene oxide for sterilization may be imposed in the future, both domestically and outside the U.S. 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. 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.
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. We cannot predict what the final PID adopted by the EPA may require and therefore we are not able to assess the impact on our sterilization facilities, on the third-party sterilization facilities that BD utilizes and our operations more generally.
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. 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. BD has business continuity plans in20
Table of Contentsplace 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. Business - Regulation” for a discussion of the consent order BD entered into with the Environmental Protection Division of the Georgia Department of Natural Resources and the risk related to sterilization operations generally.
Climate change, or legal, regulatory or market measures to address climate change, could adversely affect our business, financial condition or results of operations.
Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases (“GHG”) in the atmosphere may present risks to our business and operations. 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. In addition, access to and pricing of certain natural resources, such as water, could impact our manufacturing operations. Such conditions could also result in physical damage to our products, plants and distribution centers, as well as the infrastructure and facilities of our suppliers and of hospitals, medical care facilities and other customers.
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 been, and in the future there may be additional, legislation or regulations enacted or promulgated in the United States and in other jurisdictions in which we do business that impose more stringent restrictions and requirements on our operations than our historical legal or regulatory obligations as well as additional disclosure or reporting requirements. We have experienced, and companies in our supply chain may experience, increased compliance burdens and costs to meet the regulatory obligations. Such increased compliance burdens and costs could cause disruption in the sourcing, manufacturing and distribution of our products and adversely affect our business, financial condition or results of operations.
Additionally, the impacts of climate change may further influence customer and other stakeholder preferences and requirements. This includes increased demand for more sustainable products, including products with lower environmental footprints, and for companies to produce and demonstrate progress against sustainability goals and GHG reduction targets, including product-level GHG emissions data. 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.We are or have been a defendant in a number of lawsuits, including, among others, purported class action lawsuits for alleged antitrust violations and violations of federal securities laws, environmental and product liability claims (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 in the future involve, lawsuits seeking class action status or seeking to establish multi-district litigation or other consolidated proceedings) and suits alleging patent infringement. We also are or have been subject to government investigations and civil investigative demands seeking information with respect to alleged violations of law, including in connection with federal and/or state healthcare programs (such as Medicare or Medicaid), the federal securities laws, federal contracting requirements and/or sales and marketing practices, among other things. A more detailed description of certain litigation to which we are a party is contained in Note 6 to the consolidated financial statements included in “Item 8. Financial Statements and Supplementary Data.” We could be subject to additional lawsuits, governmental investigations, subpoenas and civil investigative demands in the future. Any such lawsuits, governmental investigations, subpoenas and
21Table of Contentscivil investigative demands could ultimately have a material adverse effect on our results of operations, financial condition and liquidity, and could distract management from the operations of the business.
Reserves established for estimated losses with respect to legal proceedings do not represent an exact calculation of our actual liability, but instead represent our estimate of the probable loss at the time the reserve is established to the extent future losses are probable and reasonably estimable. Due to the inherent uncertainty of litigation and our underlying loss reserve estimates, additional reserves may be established or current reserves may be significantly increased from time-to-time. Also, in some instances, we are not able 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. In view of these uncertainties, we could incur charges materially in excess of any currently established accruals and, to the extent available, excess liability insurance. 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. These activities have resulted in settlements for certain matters and going forward could result in further settlements, any of which may be confidential and could be significant and result in charges in excess of accruals. Any such future charges, individually or in the aggregate, could have a material adverse effect on our results of operations, financial condition and/or liquidity.With respect to certain litigation, we believe that some settlements and judgments, as well as legal defense costs, may be covered in whole or in part under applicable insurance policies with a limited number of insurance companies, or, in some circumstances, indemnification obligations owed to us by other parties. However, amounts recovered under these arrangements may be less than the stated coverage limits or less than otherwise expected and may not be adequate to cover damages and/or costs. In addition, there is no guarantee that insurers or other parties will pay claims or that coverage or indemnity will be otherwise available. Also, for certain product liability claims or lawsuits, BD does not maintain or has limited remaining insurance coverage, and we may not be able to obtain additional insurance on acceptable terms or at all that will provide adequate protection against potential liabilities.
We are subject to extensive regulation.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. Violations of these laws can result in criminal or civil sanctions, including substantial fines and, in some cases, exclusion from participation in healthcare programs such as Medicare and Medicaid. 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. 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.
We are subject to extensive regulation by the FDA pursuant to the Federal Food, Drug and Cosmetic Act, by comparable agencies in foreign countries, and by other regulatory agencies and governing bodies. Most of our products must receive authorization from the FDA or counterpart regulatory agencies in other countries before they can be marketed or sold. This process may require us to incur significant costs in terms of time and resources, and these costs have been increasing due to increased requirements from the FDA and comparable governing bodies for supporting data for submissions. The regulatory process may also require changes to our products or result in limitations on the indicated uses of 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
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to market our products in those countries. 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 ). We have made modifications to certain of our products in the past and have determined based on our review of our internal documentation and data and the applicable FDA or foreign regulations and guidance that in certain instances new 510(k) clearances or other premarket submissions were not required. We may make similar modifications or add additional features in the future that we believe do not require a new clearance or approval. If the FDA or a foreign regulator disagrees with our determinations, we may be required to cease marketing and/or to recall the modified product until we obtain a new marketing authorization, which could result in lost revenue, additional costs and damage to our reputation. 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. 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 failure to comply with the applicable good manufacturing practices, adverse event reporting and other post market requirements of these agencies could delay or prevent the production, marketing or sale of our products and result in delays or suspensions of regulatory clearances, warning letters or consent decrees, closure of manufacturing sites, import bans, seizures or recalls of products, civil or criminal sanctions and damage to our reputation. 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. We are also currently operating under two warning letters issued by the FDA for our Dispensing and Specimen Management businesses. For more information regarding the consent decree and warning letters, see “Regulation” under Item 1. Business.
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. In accordance with our commitments to the FDA, 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. The overall timing and cost of replacement or remediation of the BD Alaris™ Infusion Systems and return to market in the U.S. may be impacted by, among other things, customer readiness, supply continuity, and our continued engagement with the FDA.
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. 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. This longer transition timeline applies only to devices that are transitioning to MDR and meet other specific conditions set out in the EU IVDR. The EU IVDR has been fully applicable for manufacturers of in vitro diagnostic medical devices since May 2022. Complying with and maintaining devices under these regulations requires us to incur significant expenditures. 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. 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 ContentsWe 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. These laws, rules and regulations require companies to, among other things, proactively implement effective programs and enhance internal policies, business practices, processes, and controls and could impose significant limitations and additional compliance costs on us. In addition, these laws, rules and regulations require us to embed privacy, security and data protection requirements in all assets impacting the processing of personal data and could also require us to modify current or future products or services, which may harm our future financial results. Any actual or perceived noncompliance with these laws, rules and regulations, our internal policies and procedures or our contracts governing the processing of personal data could result in significant consequences for BD, including, among other things, business interruption, sanctions and significant pecuniary fines, regulatory inquiries and investigations, adverse publicity, loss of competitive advantage and customer trust, as well as privacy litigation and civil lawsuits with damages.
The importance of privacy and data protection laws, rules and regulations for the healthcare and med-tech industry specifically is constantly growing, as personal data is an integral part of doing business in our sector, and the legal standards are evolving and becoming more complex worldwide. A significant number of countries where we operate have enacted privacy or data protection laws, rules and regulations, the majority of which have extraterritorial scope, creating significant compliance challenges as we seek to maintain our global reach, with significant penalties for non-compliance, based on total worldwide annual revenue from the preceding financial year. In some cases, there are restrictions on the transfer of personal data outside the home country. More recently, privacy and data protection regulators are paying special attention to emerging issues linked to new digital technologies, such as the use of artificial intelligence, biometrics, and surveillance technologies, which pose unique challenges to existing privacy and data protection paradigms.
In addition, certain privacy and data protection laws, rules and regulations may apply to us indirectly through our customers, manufacturers, suppliers or other third-party partners. For example, non-compliance with applicable laws, rules or regulations by a third-party partner that is processing personal data on our behalf may be deemed non-compliant by us or a failure by us to conduct proper due diligence on the third party, which could result in material fines or litigation. We also could be subject to additional expenses and liabilities in the event of a cybersecurity incident or breach, or the failure of an IT system owned or operated by us or a third party with which we partner or its vendor.
Finally, changes in the tax laws and regulations of the jurisdictions in which we operate could increase our tax expense and/or tax payments, increase tax uncertainty and have a material adverse impact on our results of operations. 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. We continue to evaluate the impacts of the enacted Pillar Two legislation. Tax laws, inclusive of Pillar Two legislation, in the U.S. and in other countries in which we and our affiliates do business could change on a prospective or retroactive basis, and any such changes could have a material impact on our effective tax rate and on our business, results of operations, financial condition, and cash flows.
Defects or quality issues associated with our products could adversely affect the results of our operations.
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. Such events have in the past and could in the future lead to recalls or safety alerts relating to our products (either voluntary or as required by the FDA or similar governmental authorities in other countries), and could result, in certain cases, in the removal of a product from the market. A recall could result in significant costs, lost sales and customers, enforcement actions and/or investigations by state and federal governments or other enforcement bodies, as well as negative publicity and damage to our reputation that could reduce future demand for our products. Personal injuries relating to the use of our products can also result in24
Table of Contentssignificant 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.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. Any patent applications we own or license may not result in patents being issued and any issued patents we obtain may not provide us with any competitive advantage. Furthermore, we may fail to accurately predict all of the countries where patent protection will ultimately be desirable, and if we fail to timely file a patent application in any such country, we may be precluded from doing so at a later date. 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. 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. We also operate in countries that do not protect intellectual property rights to the same extent as in the U.S., which could make it easier for competitors to compete with us in those countries.We also rely on trade secrets and proprietary know-how with which we seek to protect our products, in part, by confidentiality agreements with certain employees, consultants and other parties. These agreements may not adequately protect our trade secrets and other proprietary rights. These agreements may be breached and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently developed by our competitors.
The loss of a significant portion of our portfolio of intellectual property assets may have an adverse effect on our earnings, financial condition or cash flows.
Risks Relating to Our Indebtedness
We may not be able to service all of our indebtedness.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. 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. Any such action may not be successful and we may be unable to service our indebtedness and fund our operations, which could have a material adverse effect on our business, financial condition or results of operations. Additionally, we may not be able to refinance existing debt on favorable or comparable terms.The agreements that govern our indebtedness impose restrictions that may affect our ability to operate our businesses.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. In addition, the agreements also require us to comply with certain financial covenants, including financial ratios. Our ability and the ability of our subsidiaries to comply with these provisions may be affected by events beyond our control. Failure to comply with these
25Table of Contentscovenants 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.Risks Relating to the Spin-off of Embecta Corp.On April 1, 2022, we completed the spin-off of Embecta Corp. (Embecta) (NASDAQ: EMBC), which holds our former Diabetes Care business and is now one of the world’s largest pure-play diabetes management companies in the world. The spin-off is intended to be a tax-free transaction for U.S. federal income tax purposes. 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.General Business Risks
We cannot guarantee that any of our strategic acquisitions, investments or alliances will be successful.
We seek to supplement our internal growth through strategic acquisitions, investments and alliances. Such transactions are inherently risky, and the integration of any newly-acquired business requires significant effort and management attention. The success of any acquisition, investment or alliance may be affected by a number of factors, including our ability to properly assess and value the potential business opportunity or to successfully integrate any business we may acquire into our existing business. There can be no assurance that any past or future transaction will be successful.Natural disasters, war and other events beyond our control could disrupt our business and adversely affect our future revenues and operating income.
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. 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.
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Information About our Executive OfficersThe 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. There is no family relationship between any executive officer or director of BD.Name Age PositionThomas 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.
Richard Byrd 57 Executive Vice President and President, Interventional Segment since September 2022; Worldwide President, BD Medication Delivery Solutions from March 2019 to September 2022; Worldwide President, Preanalytical Systems from December 2016 to February 2019.
Christopher J. DelOrefice 53 Executive Vice President and Chief Financial Officer since September 2021; Vice President, Investor Relations, Johnson & Johnson from August 2018 to September 2021; and Chief Financial Officer, North America Hospital Medical Devices, Johnson & Johnson from June 2017 to August 2018.
Antoine C. 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.
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 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.
Roland Goette 62 Executive Vice President and President, EMEA since May 2017.
Pavan Mocherla 55 Executive Vice President and President, Greater Asia since July 2022; Country General Manager, South Asia/Managing Director from December 2017 to June 2022.
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.
Michelle Quinn 56 Executive Vice President and General Counsel since April 2023; Senior Vice President, Deputy General Counsel and Chief Ethics and Compliance Officer from February 2022 to April 2023; Senior Vice President, Chief Ethics & Compliance Officer, Chief Regulatory Counsel from May 2019 to January 2023; Senior Vice President, Chief Compliance Officer from February 2019 to May 2019.
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.
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Item 1A. Risk Factors.
An investment in BD involves a variety of risks and uncertainties. The following describes some of the material risks that could adversely affect BD’s business, financial condition, operating results or cash flows. We may also be adversely impacted by other risks not presently known to us or that we currently consider immaterial.
Business, Economic and Industry Risks
Global economic conditions, including inflation and supply chain disruptions, could continue to adversely affect our 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. 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. 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.
We have also experienced, and may continue to experience, challenges in our global supply chain, including shortages in supply, or disruptions in production and shipments, of certain materials or components used in our products and related price increases. While to date, we have been able to manage the challenges associated with these delays and shortages without significant disruption to our business, no assurance can be given that these efforts will continue to be successful.Our international operations subject us to certain business 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. 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. These conditions include instability resulting from war, terrorism, insurrections and civil unrest, political conflict and changing economic conditions, such as inflation, deflation, interest rate volatility and credit availability.
Specifically, recently enacted or any future tariffs imposed by the U.S. government (and countermeasures by non-U.S. governments) may result in adverse impacts to the global economic environment and the stability of global financial markets, which could alter global trade. The tariffs, sanctions or other trade barriers imposed by the U.S. (and countermeasures by non-U.S. governments) could adversely impact our supply chain costs or availability of certain components, demand for our products and our business, financial condition, results of operations and cash flows. Unpredictability of trade policy compounds this risk. Based upon the latest published tariffs that are currently in effect, we expect tariffs to adversely impact our operating expense for fiscal year 2026 and potentially beyond, primarily relating to any products (or components) imported from countries across our global supply chain, for which there are limited mitigation opportunities.14
Table of ContentsFurther, the U.S. Department of Commerce recently initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, into (among other things) imports of personal protective equipment, medical consumables and medical equipment (including devices), to determine whether they threaten U.S. national security, which further creates policy uncertainty in terms of tariffs. The ultimate impact of any existing or new tariffs or other changes in international trade policies on our business, financial condition, results of operations and cash flows is subject to a number of factors, including, but not limited to, the duration of such tariffs, changes in tariff rates, the amount, scope and nature of the tariffs, any countermeasures that target countries may take or any mitigating actions that may become available. While sourcing optimization and tariff exemptions for qualifying products are key aspects of our mitigation strategy, the timing of such or the ultimate results we will realize from these efforts are uncertain. In addition, our tariff mitigation strategies may be challenged, rejected or eliminated through legislation or other challenges, or may otherwise not be effective.
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. Foreign regulatory requirements, including those related to the testing authorization, and labeling of products and import or export licensing requirements, could affect the availability of our products in these markets. In addition to these broader market conditions, our operations may also be impacted by a variety of local factors, such as competition from local companies, local product preferences and requirements, changes in local healthcare payment systems and healthcare delivery systems, changes resulting from new political administrations and labor force instability.
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.
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. 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 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. 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.
We are a global company that faces significant competition from a wide range of existing competitors and new market entrants. These include large medical device companies with multiple product lines, some of which may have greater financial and other resources than we do, as well as firms which are more specialized than we are with respect to particular markets or product lines. 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. We 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 ContentsOur 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. 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. Tariffs and other cost containment efforts by governments and the private sector have led to increased competitiveness in terms of product pricing and have resulted and may continue to result in increased emphasis on products that reduce costs, improve clinical results and expand patient access. 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.
The medical technology industry is also subject to rapid technological change, discovery and frequent product introductions. The development of new or improved products, processes or technologies by other companies that provide better features, pricing, clinical outcomes or economic value may render our current products or subsequently developed products obsolete or less competitive. In some instances, competitors, including pharmaceutical companies, also offer (or are attempting to develop) alternative therapies for disease states that may be delivered without a medical device, such as oral GLP-1 medications.
The medical technology industry has also experienced a significant amount of consolidation, resulting in companies with greater scale and market presence than BD. Traditional distributors are also manufacturers of medical devices, providing another source of competition. In addition, healthcare systems and other providers are consolidating, resulting in greater purchasing power for these companies. As a result, competition among medical device suppliers to provide goods and services has increased. Group purchasing organizations and integrated health delivery networks have also served to concentrate purchasing decisions for some customers, which has led to downward pricing pressure for medical device suppliers. Further consolidation in the industry could intensify competition among medical device suppliers and exert additional pressure on the demand for and prices of our products.
Market dynamics, changes in reimbursement practices and coverage policies, third-party payer cost containment measures and health insurance coverage levels could affect demand for our products and the prices at which they are sold.
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. Coverage policies and reimbursement levels can vary across the payer community globally, regionally and locally, and may affect which products customers purchase, the market acceptance rate for new technologies and the prices customers are willing to pay for those products in a particular jurisdiction. In addition, third-party payers are increasingly challenging the reimbursement models and prices charged for medical products and services. Any changes to the reimbursement landscape, or adverse decisions relating to our products by administrators of these systems could significantly reduce reimbursement for procedures using our products or result in denial of reimbursement for those products, which could adversely affect customer demand, or the price customers are willing to pay for such products. See “Third-Party Reimbursement” under “Item 1. Business.”
A global trend towards limiting growth of healthcare costs may also put industry-wide pressure on medical device or clinical diagnostic pricing. In the U.S., the Center for Medicaid Services (“CMS”) has proposed the expansion of its Competitive Bidding Program (“CBP”). This proposed expansion would introduce a pricing model that could significantly influence the cost structure of some medical devices in the U.S. healthcare system; specifically, those reimbursed under CMS’ Durable Medical Equipment, Prosthetic, Orthotic and Supplies payment system. By leveraging supplier competition to establish payment rates, the CBP mirrors purchasing initiatives seen in international markets, where procurement strategies attempt to prioritize16
Table of Contentscost-efficiency, which could lead to uncertainty with respect to innovation, quality and patient access challenges or supplier attrition, as seen in prior bidding cycles. In addition, we expect recently enacted and proposed changes under legislative debate to Medicare, Medicaid and the Affordable Care Act to impact healthcare coverage, all of which if implemented could adversely affect both the demand and prices customers are willing to pay for our products. 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.Reductions in customers’ research budgets or government funding may adversely affect our business.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 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. National Institutes of Health and similar agencies in other countries. The level of government funding of research and development is unpredictable and we have seen a reduction in government funding in fiscal year 2025. The availability of governmental research funding has been, and may in the future be, adversely affected by policy changes, economic conditions and governmental spending reductions, including the downsizing or reduced funding of certain government agencies. Further, an extended federal government shutdown resulting from a failure to pass budget appropriations, adopt continuing funding resolutions or raise the debt ceiling, together with any other budgetary decisions limiting or delaying government spending, could negatively impact U.S. or global economic conditions.
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. The results of our product development efforts may be affected by a number of factors, including our ability to anticipate customer needs, innovate and develop new products and technologies, successfully complete clinical trials, obtain regulatory approvals and reimbursement in the U.S. and abroad, manufacture products in a cost-effective manner, obtain appropriate intellectual property rights and gain and maintain market acceptance of our products. In addition, patents attained by others can preclude or delay our commercialization of a product. There can be no assurance that any products now in development, or that we may seek to develop in the future, will achieve technological feasibility, obtain regulatory approval or gain market acceptance. If we are unable to develop and launch new products, our ability to maintain or expand our market position in the markets in which we participate may be negatively impacted. Even if we successfully develop new products or enhancements or new generations of existing products, they may be quickly rendered obsolete by changing customer preferences, changing industry or regulatory standards, or competitors’ innovations.
We are subject to foreign currency exchange risk.
A substantial amount of our revenue is derived from international operations, and we anticipate that a significant portion of our future sales will continue to come from outside the U.S. 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. 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. 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
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in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 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.We need to attract and retain key employees to be competitive.Our ability to compete effectively depends upon our ability to attract and retain executives, key employees and other associates. Competition for experienced employees, particularly for persons with certain technical competencies in some geographies, can be a challenge. 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. 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. A sustained labor shortage or increased turnover rates within our employee base has led to, and may continue to lead to, increased costs, such as an increase in overtime necessary to meet demand and increased wages and benefit costs to attract and retain skilled employees, and could negatively affect our ability to efficiently operate our manufacturing and distribution facilities and overall business. If we cannot effectively recruit and retain qualified executives and skilled employees, we could encounter operational disruptions or other negative consequences to our business, financial condition or results of operations.Operational Risks
Cybersecurity incidents and breaches or breakdowns of our information and technology systems or infrastructure could have a material adverse effect on our operations.We rely on a large number of information and technology (“IT”) systems and related infrastructure, including services provided to us by third-party vendors to operate our business. We collect, use, store, transfer and otherwise process electronic information in our day-to-day operations, including personal, confidential, or proprietary information of BD and its customers, vendors and other business partners and patients. 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. We also have products and systems that connect to the internet, hospital networks, electronic medical record systems or electronic health record systems. 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. 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. The foregoing could expose us to further risk of potential breaches, failures, interruptions and disruptions, which could result in adverse consequences, including regulatory inquiries or litigation, increased costs and expenses, reputational damage, lost revenue, and fines or penalties. In particular, risks associated with the deployment and use of AI into our operations generally could introduce new risks related to the management of our information and technology systems and related infrastructure and our overall cybersecurity threat landscape.
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. In addition, while we continue to enhance business continuity and disaster recovery plans and strategies, there is no guarantee that such plans and strategies will be effective or account for all eventualities. We have experienced, and could in the future experience, the failure, interruption or disruption of the functionality of our IT systems and infrastructure (or those of third-party vendors upon which we rely), which could impair our ability or that of our customers, suppliers and other business partners to18
Table of Contentsconduct business. Such a disruption could also result in the loss of our trade secrets or otherwise compromise personal, confidential or proprietary information of ours or our customers, suppliers and other business partners, or of patients. Additionally, depending on the nature of such a disruption, it could result in efficacy or safety concerns for certain of our products, result in reputational harm to our business and result in actions by regulatory bodies or civil litigation.
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 IT systems and infrastructure, as well as those of various third parties on which we rely, have experienced, and are likely to continue to experience, a variety of cyberattacks, including, but not limited to, unauthorized access, malicious code execution and/or phishing attacks, which could be further exacerbated by rapid technology evolution, including increased adoption of AI and geopolitical events. For example, AI is increasingly being used by malicious actors to create more targeted cyberattacks and spread misinformation. These cyberattacks have resulted, and could in the future result, in our and our customers’ personal, confidential or proprietary information being accessed, destroyed, lost, stolen or otherwise compromised and could lead to increased costs for cybersecurity measures, insurance or remediation and adversely affect our reputation, financial condition, results of operations or competitive position in the market and result in other significant negative consequences, including lost revenue, damages or fines, manufacturing challenges or disruption, diversion of management attention, litigation, regulatory action and damage to our relationships with vendors, business partners and customers.
Unauthorized tampering, adulteration or interference with our products, including through cyberattacks, may also create issues with product functionality that could result in a loss or alteration of data, risk to patient safety and product recalls or field actions, as well as impact our compliance with privacy, data protection and other laws and regulations and could result in reputational damage and actions by regulatory bodies or civil litigation.
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. While we attempt to mitigate these risks through due diligence, risk assessments and the implementation of cybersecurity controls and protocols during and after the acquisition process, there can be no assurance that such measures will be sufficient to prevent, mitigate or remediate cybersecurity incidents or breaches, which could have a material adverse effect on our business, financial condition and results of operations.
While we have made, and expect to continue making, significant investments intended to strengthen our cybersecurity posture—including measures designed to protect our products, systems, and data—we cannot guarantee that these efforts will fully prevent, mitigate or remediate cybersecurity incidents or breaches. We maintain processes designed to monitor, detect and respond to threats and collaborate with government authorities and third-party partners in an effort to reduce risk. However, given the evolving nature, sophistication, scale and frequency of cybersecurity incidents and breaches, no system can be entirely secure. A successful cybersecurity incident or breach could materially adversely affect our business, financial condition, results of operations or cash flows.
The development, deployment and use of AI in our products and business operations generally could result in regulatory action, legal liability, operational challenges or reputational harm and our failure to adapt to medical technology industry trends and developments related to AI in a timely manner (or at all) could adversely affect our business, financial condition, results of operations and cash flows.
We have integrated (and expect to continue to integrate) AI into our products and business operations generally. We also expect to continue to develop future uses of AI and expand our existing AI capabilities to include agentic solutions, as well as pursue new AI technology partnerships with third parties. The development, deployment and use of AI (particularly generative AI) is in the early stages and presents various19
Table of Contentsrisks, including from confidentiality, privacy, data protection, cybersecurity and compliance perspectives, and raises intellectual property issues and legal, regulatory, reputational ethical, operational, technological and other concerns (see, “Our operations are dependent in part on patents and other intellectual property assets” and “Cybersecurity incidents and breaches or breakdowns of our information and technology systems or infrastructure could have a material adverse effect on our operations” elsewhere in this Item 1A, Risk Factors). Additionally, if we do not effectively adopt and integrate AI into innovative, market-differentiated products in a timely manner, our competitive position could be adversely affected.
A reduction or interruption in the supply of certain raw materials and components could adversely affect our operating results.
We purchase many different types of raw materials and components used in our products, some of which are not available from multiple sources. In addition, for quality assurance, cost-effectiveness and other reasons, certain raw materials and components are purchased from sole suppliers. Our reliance on sole suppliers can create greater exposure to shortages, magnify price swings and increase the difficulty of negotiating favorable terms. 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. We have experienced, and may continue to experience, significant challenges to our global transportation channels and other aspects of our global supply chain network, including to the cost and availability of energy, raw materials and components due to shortages, labor strikes and cost inflation. 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. In addition, due to regulatory requirements relating to the qualification of suppliers, we may not be able to establish additional or replacement sources on a timely basis or without excessive cost. The termination, reduction or interruption in supply of these raw materials and components could adversely impact our ability to manufacture and sell certain of our products, which could have an adverse impact on our business, financial condition and results of operations.
Interruption of our manufacturing or sterilization operations could adversely affect our business.
We have manufacturing sites all over the world. In some instances, however, the manufacturing of certain of our product lines is concentrated in one or a few of our plants. Interruption to our manufacturing operations resulting from system outages, cybersecurity incidents or breaches, weather or natural disasters, regulatory requirements, labor disruptions, equipment failure or other issues in our manufacturing process, could adversely affect our ability to manufacture our products. In some instances, we may not be able to transition manufacturing to other BD sites or a third party to replace the lost production. A significant interruption of our manufacturing operations could result in lost revenues and damage to our relationships with customers.
In addition, many of our products require sterilization prior to sale, and we utilize both BD facilities and third parties for this process. In some instances, only a few facilities are qualified under applicable regulations to conduct this sterilization. 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 ContentsAt a broader level, there is continued focus on the use and emission of ethylene oxide by the EPA and state environmental regulatory agencies. Additional regulatory requirements associated with the use and emission of ethylene oxide for sterilization may be imposed in the future, both domestically and outside the U.S. 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. While companies were initially given two years from the effective date to comply with the new requirements of the NESHAP generally, in July 2025, the current U.S. administration issued an executive order exempting medical device sterilization facilities (including certain of our facilities) from compliance with such requirements for two years beyond the initial April 2026 compliance deadline. We implemented certain changes to our facilities in accordance with NESHAP’s requirements in 2024 and 2025 and are in the process of implementing certain additional changes to our facilities to achieve compliance with such requirements by April 2028.
In addition, on April 13, 2023, the EPA published a Pesticide Registration Review: Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide. On January 14, 2025, the EPA published the 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. Among other things, the ID requires medical device sterilization facilities to comply with a new and stricter occupational ethylene oxide exposure limit, establish engineering controls for worker protection, provide workers with personal protective equipment, conduct continuous stationary indoor monitoring and comply with a maximum concentration limit for ethylene oxide (with higher levels permitted if required and approved by the FDA). Compliance deadlines for the various mitigation measures required by the ID range from within 60 days to ten years of the effective date. We are in the process of assessing the impact of the ID requirements on our sterilization facilities, the third-party sterilization facilities that we utilize and our operations generally. We expect to implement certain changes at our facilities to comply with NESHAP and ID requirements, which will require us to incur additional implementation and ongoing operating 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. 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. 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 .
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. 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. 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. 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. 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.
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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.
Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases (“GHG”) in the atmosphere may present risks to our business and operations. 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. In addition, access to (and pricing of) certain natural resources, such as water, could impact our manufacturing operations. Such conditions could also result in physical damage to our products, plants and distribution centers, as well as the infrastructure and facilities of our suppliers and of hospitals, medical care facilities and other customers.
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. Additional legislation or regulations in the United States and in other jurisdictions in which we and our suppliers operate may impose more stringent restrictions, and disclosure obligations. We and companies in our supply chain have experienced, and may continue to experience, increased compliance burdens and costs to meet these obligations. If we or our suppliers are unable or unwilling to comply with these obligations, it could be more difficult and/or costly to manufacture and sell certain of our products and we could experience supply chain interruptions, including impacts to sourcing and distribution. In addition, we could be subject to litigation, substantial fines and other damages if we fail to comply with these obligations, which could adversely impact our business, financial condition, results of operations and cash flows.
Climate change and related regulations and sustainability efforts may also influence customer, shareholder and other stakeholder preferences and requirements, including in diverging directions. This includes increased or shifting demand for more sustainable products and for progress toward sustainability goals and GHG reduction targets, including product-level GHG emissions data. 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.We are or have been a defendant in a number of lawsuits, including, among others, purported class action lawsuits for alleged antitrust violations and violations of federal securities laws, environmental and product liability claims (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 in the future involve, lawsuits seeking class action status or seeking to establish multi-district litigation or other consolidated proceedings) and suits alleging patent infringement. We also are or have been subject to government investigations and civil investigative demands seeking information with respect to alleged violations of law, including in connection with federal and/or state healthcare programs (such as Medicare or Medicaid), the federal securities laws, federal contracting requirements and/or sales and marketing practices, among other things. A more detailed description of certain litigation to which we are a party is contained in Note 6 to the consolidated financial statements included in “Item 8. Financial Statements and Supplementary Data.” We could be subject to additional lawsuits, governmental investigations, subpoenas and civil investigative demands in the future. Any such lawsuits, governmental investigations, subpoenas and civil investigative demands could ultimately have a material adverse effect on our results of operations, financial condition and liquidity, and could distract management from the operations of the business.
22Table of ContentsAccruals are established for legal proceedings 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. 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 we are a party. Also, accruals relating to legal proceedings may change in the future as new information for an individual matter becomes available or due to changes in our litigation strategy. 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 our consolidated results of operations, financial condition and/or consolidated cash flows. 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. These activities have resulted in settlements for certain matters and going forward could result in further settlements, any of which may be confidential and could be significant and result in charges in excess of accruals. Any such future charges, individually or in the aggregate, could have a material adverse effect on our results of operations, financial condition and/or liquidity.With respect to certain litigation, we believe that some settlements and judgments, as well as legal defense costs, may be covered in whole or in part under applicable insurance policies with a limited number of insurance companies, or, in some circumstances, indemnification obligations owed to us by other parties. However, amounts recovered under these arrangements may be less than the stated coverage limits or less than otherwise expected and may not be adequate to cover damages and/or costs. In addition, there is no guarantee that insurers or other parties will pay claims or that coverage or indemnity will be otherwise available. Also, for certain product liability claims or lawsuits, BD does not maintain or has limited remaining insurance coverage, and we may not be able to obtain additional insurance on acceptable terms or at all that will provide adequate protection against potential liabilities.
We are subject to extensive regulation.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. Violations of these laws can result in criminal or civil sanctions, including substantial fines and, in some cases, exclusion from participation in healthcare programs such as Medicare and Medicaid. 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. 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 are subject to extensive regulation by the FDA pursuant to the Federal Food, Drug and Cosmetic Act, by comparable agencies in foreign countries, and by other regulatory agencies and governing bodies. Most of our products must receive authorization from the FDA or counterpart regulatory agencies in other countries before they can be marketed or sold. This process may require us to incur significant costs in terms of time and resources, and these costs have been increasing due to increased requirements from the FDA and comparable governing bodies for supporting data for submissions. The regulatory process may also require changes to our products or result in limitations on the indicated uses of 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 to market our products in those countries. In addition, government shutdowns, recent reductions in U.S. government agency staffing and government spending more generally could impact ordinary course operations of agencies with which we interact routinely, such as the FDA. Following these reductions, the agencies may23
Table of Contentslack adequate staff and resources to meet current review, approval and inspection schedules, which could delay the receipt of or otherwise adversely affect the outcomes of product authorizations we seek.
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 ). We have made modifications to certain of our products in the past and have determined based on our review of our internal documentation and data and the applicable FDA or foreign regulations and guidance that in certain instances new 510(k) clearances or other premarket submissions were not required. We may make similar modifications or add additional features in the future that we believe do not require a new marketing authorization. If the FDA or a foreign regulator disagrees with our determinations, we may be required to cease marketing and/or to recall the modified product until we obtain a new marketing authorization, which could result in lost revenue, additional costs and damage to our reputation. 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. 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. Our failure to comply with the applicable good manufacturing practices, adverse event reporting and other post market requirements of these agencies could delay or prevent the production, marketing or sale of our products and result in delays or suspensions of regulatory clearances, warning letters or consent decrees, closure of manufacturing sites, import bans, seizures or recalls of products, civil or criminal sanctions and damage to our reputation. 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. We are also currently operating under two warning letters issued by the FDA for our Dispensing and Specimen Management businesses. For more information regarding the consent decree and warning letters, see “Regulation” under Item 1. Business.
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. 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. The overall timing and cost of replacement or remediation of the BD Alaris™ Infusion Systems and return to market in the U.S. may be impacted by, among other things, customer readiness, supply continuity, and our continued engagement with the FDA.
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. 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. The EU IVDR has been applicable since May 2022, but transition periods apply for certain in vitro diagnostic medical devices. Complying with and maintaining devices under these regulations requires us to incur significant expenditures. 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. 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 ContentsWe 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. The nature of our technologies and data-driven solutions amplifies privacy and data protection risks, especially as we employ could-based infrastructures, AI and other emerging digital capabilities. These innovations can introduce new vectors for data exposure, algorithmic bias, and regulatory scrutiny. These laws, rules and regulations require, among other things, proactive implementation of comprehensive compliance programs, continuous enhancement of internal policies, business practices, processes, and integration of technical and organizational safeguards across all assets and activities that process personal data. These requirements often entail operational constraints and higher compliance costs and may require us to modify existing or future products, potentially impacting innovation timelines and financial performance.
Furthermore, privacy and data protection risks extend beyond our direct operations. Non-compliance by third-party vendors, manufacturers, or service providers (especially those involved in data processing) can expose us to liability indirectly. Cybersecurity incidents, system failures, or breaches involving our own infrastructure or that of our partners may trigger regulatory scrutiny, financial penalties, business interruption, reputational harm, loss of competitive advantage and customer trust, as well as privacy litigation and civil lawsuits with damages.
Finally, changes in the tax laws and regulations of the jurisdictions in which we operate could increase our tax expense and/or tax payments, increase tax uncertainty and have a material adverse impact on our results of operations. 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. Future changes in U.S. or foreign tax laws, including under Pillar Two, whether prospective or retroactive, could materially impact our effective tax rate, business, results of operations, financial condition and cash flows.
Defects or quality issues associated with our products and related regulatory actions could adversely affect our results of operations and financial statements.
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 acquisition and integration of acquired companies increases our exposure to this risk. Such events have in the past and could in the future lead to recalls or safety alerts relating to our products (either voluntary or as required by the FDA or similar governmental authorities in other countries), and could result, in certain cases, in the removal of a product from the market. In addition, any recall could result in the establishment or increase in financial reserves, which in turn would increase financial reporting and other disclosure obligations, the loss of sales and customers, enforcement actions and/or investigations by state and federal governments or other enforcement bodies and related fines and penalties, as well as negative publicity and damage to our reputation that could reduce future demand for our products. 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.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. Any patent applications we own or license may not result in patents being issued and any issued patents we obtain may not provide us with any competitive advantage. Furthermore, we may fail to accurately predict all of the countries where patent protection will ultimately be desirable, and if we fail to timely file a patent application in any such country, we may be precluded from doing so at a later date. 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
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technologies and products without infringing our intellectual property rights. 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. We also operate in countries that do not protect intellectual property rights to the same extent as in the U.S., which could make it easier for competitors to compete with us in those countries. Further, governmental regulation and laws related to AI and other emerging technologies may increase the burden and cost of research and development or require increased transparency that makes it more difficult to protect our intellectual property.We also rely on trade secrets and proprietary know-how with which we seek to protect our products, in part, by confidentiality agreements with certain employees, consultants and other parties. These agreements may not adequately protect our trade secrets and other proprietary rights. These agreements may be breached and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently developed by our competitors.
The loss of a significant portion of our portfolio of intellectual property assets may have an adverse effect on our earnings, financial condition or cash flows.
Risks Relating to Our Indebtedness
We may not be able to service all of our indebtedness.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. There can be no assurance that these sources will be adequate. Further, our ability to refinance our indebtedness could be adversely impacted by the loss of our “well-known seasoned issuer” status upon the filing of this annual report due to our entry into a December 2024 SEC Order. 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. Any such action may not be successful and we may be unable to service our indebtedness and fund our operations, which could have a material adverse effect on our business, financial condition or results of operations. Additionally, we may not be able to refinance existing debt on favorable or comparable terms.The agreements that govern our indebtedness impose restrictions that may affect our ability to operate our businesses.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. In addition, the agreements also require us to comply with certain financial covenants, including financial ratios. Our ability and the ability of our subsidiaries to comply with these provisions may be affected by events beyond our control. 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. Under these circumstances, we might not have sufficient funds or other resources to satisfy all of our obligations.
26Table of ContentsRisks Relating to the Proposed Combination of Our Biosciences and Diagnostics Solutions Business with Waters
The proposed combination of our Biosciences and Diagnostic Solutions business with Waters may not be completed, on the currently contemplated timeline or at all.
On July 13, 2025, we entered into a definitive agreement with Waters to combine our Biosciences and Diagnostic Solutions business with Waters. The transaction, if consummated, would result in our shareholders owning approximately 39.2% of the combined company and existing Waters shareholders owning approximately 60.8% of the combined company. The transaction is expected to close around the end of the first quarter of calendar year 2026, subject to receipt of required regulatory approvals, Waters stockholder approval, compliance with applicable SEC requirements, the receipt of a private letter ruling from the Internal Revenue Service regarding certain matters germane to the U.S. federal income tax consequences of the transactions and satisfaction of other customary closing conditions. No assurances can be provided that such closing conditions will be satisfied or waived or that the transaction will be consummated, on the currently contemplated timeline or at all. A failure to complete the transaction, or a delay in doing so, could adversely impact our business, financial condition, results of operations and cash flows. In the event that the transaction does not close, we will be required to bear significant non-recurring costs in connection with the transaction.
The announcement and pendency of the combination of our Biosciences and Diagnostic Solutions business with Waters could cause disruptions in our business.
The completion of the separation of our Biosciences and Diagnostic Solutions business and combination of the business with Waters will require significant amounts of time and effort, which could divert management attention, disrupt the activities of our employees and have negative implications for our relationships with our customers and other third parties. We have already incurred and expect to incur additional costs and expenses in connection with the separation and combination. Until the consummation or termination of the transaction, we are also required to operate the business in the ordinary course and we are restricted from taking certain specified actions with respect to our Biosciences and Diagnostic Solutions business without Waters’ consent. Any of the foregoing could adversely affect our business, financial condition, result of operations and cash flows.
We may not realize some or all of the expected benefits of the combination of our Biosciences and Diagnostic Solutions business with Waters.
If the separation of our Biosciences and Diagnostic Solutions business and combination of the business with Waters is completed, the anticipated operational, financial, strategic and other benefits of such transaction to us and our shareholders may not be achieved. In addition, we have agreed to provide certain transition services to the combined company, which may result in additional expenses and may divert our focus and resources that would otherwise be invested into maintaining or growing our businesses. An inability to realize tsome or all of the anticipated benefits of the transaction, as well as any delays encountered in the process, could have an adverse effect on our business, financial condition, results of operations and cash flows. In addition, while it is expected that the transaction would be generally tax-free for U.S. federal income tax purposes to us and our shareholders, no assurances can be provided that the transaction will qualify for such treatment. If the transaction is ultimately determined to be taxable, this could result in significant U.S. federal income tax liabilities for us and our shareholders. Any of the foregoing could adversely affect our business, financial condition, results of operations and cash flows.Risks Relating to the Spin-off of Embecta Corp.On April 1, 2022, we completed the spin-off of Embecta Corp. (“Embecta”) (NASDAQ: EMBC), which holds our former Diabetes Care business. The spin-off is intended to be a tax-free transaction for U.S. federal income tax purposes. 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
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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.General Business Risks
We cannot guarantee that any of our strategic acquisitions, investments or alliances will be successful.
We seek to supplement our internal growth through strategic acquisitions, investments and alliances. Such transactions are inherently risky, and the integration of any newly-acquired business requires significant effort and management attention. The success of any acquisition, investment or alliance may be affected by a number of factors, including our ability to properly assess and value the potential business opportunity or to successfully integrate any business we may acquire into our existing business. There can be no assurance that any past or future transaction will be successful.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.
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. Such events are inherently unpredictable, and our responses may involve the implementation of measures which may not be successful. 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.
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Information About our Executive OfficersThe 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. There is no family relationship between any executive officer or director of BD.Name Age PositionThomas 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.
Richard Byrd 58 Executive Vice President and President, Interventional Segment since September 2022; Worldwide President, BD Medication Delivery Solutions from March 2019 to September 2022.
Christopher J. DelOrefice 54 Executive Vice President and Chief Financial Officer since September 2021; Vice President, Investor Relations, Johnson & Johnson from August 2018 to September 2021.
Antoine C. 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.
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.
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.
Pavan Mocherla 56 Executive Vice President and President, Greater Asia since July 2022; Country General Manager, South Asia/Managing Director from December 2017 to June 2022.
Bilal Muhsin 45 Executive Vice President and President of Connected Care Segment since July 2025; Chief Operating Officer of Masimo Corporation from April 2019 to July 2025.
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.
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.
Item 7 · Management's Discussion & Analysis
+245 paragraphs −243 paragraphs ~243 changed
FY 2024-09-30 (earlier)
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following commentary should be read in conjunction with the consolidated financial statements and accompanying notes presented in this report. Within the tables presented throughout this discussion, certain columns may not add due to the use of rounded numbers for disclosure purposes. Percentages and earnings per share amounts presented are calculated from the underlying amounts. References to years throughout this discussion relate to our fiscal years, which end on September 30.
Company Overview
Description of the Company and Business Segments
Becton, Dickinson and Company (“BD”) is a global medical technology company engaged in the development, manufacture and sale of a broad range of medical supplies, devices, laboratory equipment and diagnostic products used by healthcare institutions, physicians, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. The Company's organizational structure is based upon three principal business segments, BD Medical (“Medical”), BD Life Sciences (“Life Sciences”) and BD Interventional (“Interventional”).
BD’s products are manufactured and sold worldwide. Our products are marketed in the United States and internationally through independent distribution channels and directly to end-users by BD and independent sales representatives. We organize our operations outside the United States as follows: EMEA (which includes Europe, the Middle East and Africa); Greater Asia (which includes countries in Greater China, Japan, South Asia, Southeast Asia, Korea, Australia and New Zealand); Latin America (which includes Mexico, Central America, the Caribbean and South America); and Canada. 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 ObjectivesBD remains focused on delivering durable growth, creating shareholder value and making appropriate investments for the future. BD 2025, our vehicle for value creation, is anchored in three key pillars: grow, simplify and empower. 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.
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.
Empower
• Fostering a purpose-driven culture with a focus on positive impact to all stakeholders–customers, patients, employees, shareholders and communities;
• Cultivating an inclusive work environment that welcomes and celebrates diverse backgrounds and perspectives;
• Growing and enabling talent through training, development and reskilling strategies; and
• Driving sustainability initiatives within our organizational units to support enterprise-wide collaboration towards our sustainability strategy.
In assessing the outcomes of these strategies as well as BD’s financial condition and operating performance, management generally reviews forecast data, monthly actual results, including segment sales, and other similar information. 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.Acquisition of Edwards Lifesciences’ Critical Care Product GroupOn September 3, 2024, we completed the acquisition of Edwards Lifesciences’ Critical Care product group (“Critical Care”), which we renamed as BD Advanced Patient Monitoring (“Advanced Patient Monitoring”), for total consideration of $3.911 billion. Advanced Patient Monitoring is a global leader in advanced monitoring solutions that expands BD’s portfolio of smart connected care solutions with its growing set of leading monitoring technologies, advanced AI-enabled clinical decision tools and robust innovation pipeline that complement our existing technologies serving operating rooms and intensive care units.
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’s Spin-Off of Diabetes Care and Sale of Surgical Instrumentation PlatformIn 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. 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. Financial Statements and Supplementary Data.
34Table of ContentsKey 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. Macroeconomic factors which affected our operations and impacted results in fiscal year 2024 included the following:
• As anticipated, market dynamics in China, such as volume-based procurement programs (“VoBP”) and the government’s focus to improve compliance of healthcare practitioners, had an adverse impact on our results of operations and these dynamics could continue to unfavorably impact our results of operations.
• As is further discussed below, our labor costs were generally higher in our fiscal year 2024 compared with the prior-year period.
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. In general, major disruptions in the sourcing, manufacturing and distribution of our products could adversely impact our results of operations.
In addition, current healthcare delivery has transitioned more care from acute to non-acute settings and has increased focus on chronic disease management; this transition has placed additional financial pressure on hospitals and the broader healthcare system. Healthcare institutions may take actions to mitigate any persistent pressures on their budgets and such actions could impact the future demand for our products and services. Additionally, a deterioration of staffing levels within healthcare systems may affect the prioritization of healthcare services, which could also impact the demand for certain of our products. Also, reductions or delays in governmental research funding and/or higher interest rates could cause customers for our instruments and reagents to delay or forgo purchases of these products.
Certain geopolitical conditions, including the evolving situations in Ukraine, the Middle East and Asia, may impact global macroeconomic conditions, including those discussed above. While these geopolitical conditions have not materially impacted our results of operations to date, the continuation and/or an escalation of these evolving situations may weaken the global economy and could result in additional inflationary pressures and supply chain constraints, including the unavailability and cost of energy.We continue to invest in research and development, strategic tuck-in acquisitions, geographic expansion, and new product programs to drive further revenue and profit growth. Our ability to sustain our long-term growth will depend on a number of factors, including our ability to expand our core business (including strategic geographical expansion), and develop innovative new products, as well as continue to improve operating efficiency and organizational effectiveness.We have been mitigating the impacts of the macroeconomic and other factors discussed above through various strategies which leverage our procurement, logistics and manufacturing capabilities. However, there can be no assurance that we will be able to effectively mitigate these pressures in future periods and an inability to offset these pressures through our strategies, at least in part, could adversely impact our results of operations. Due to the significant uncertainty that exists relative to the duration and overall impact of the macroeconomic and other factors discussed above, our future operating performance, particularly in the short-term, may be subject to volatility. The impacts of macroeconomic and other conditions on our business, results of operations, financial condition and cash flows are dependent on certain factors, including those discussed in Part I, Item 1A. Risk Factors.
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Table of ContentsSummary of Financial ResultsWorldwide revenues in 2024 of $20.178 billion increased 4.2% from the prior-year period. This increase reflected the following impacts:Increase (decrease) in current-year revenuesVolume/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 period4.2 %(a) Volume/other includes revenues attributable to products, services and licensing.(b) Represents the recognition of accruals resulting from recent developments relating to the Italian government medical device pay back legislation, as well as another legal matter, and which substantially relate to years prior to the current fiscal year. 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.
Our financial position remains strong, with cash flows from continuing operating activities totaling $3.844 billion in 2024. At September 30, 2024, we had $2.301 billion in cash and equivalents and short-term investments, including restricted cash. We continued to return value to our shareholders in the form of dividends and during fiscal year 2024, we paid cash dividends to common shareholders of $1.100 billion.
Each reporting period, we face currency exposure that arises from translating the results of our worldwide operations to the U.S. dollar at exchange rates that fluctuate from the beginning of such period. The fiscal year 2024 impact of foreign currency translation on our revenues is provided above and the impact on our earnings is provided further below. 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. 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. 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. 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 of Operations
Updates to Financial Results Reported in Earnings Release
On November 7, 2024, we furnished a Current Report on Form 8-K that included as an exhibit a press release announcing our financial results for the fourth fiscal quarter and the fiscal year ended September 30, 2024 (the “Earnings Release”). On November 22, 2024 and subsequent to furnishing the Earnings Release, we received the Dispensing Warning Letter, as more fully discussed under Item 1. Business— Regulation—FDA
36Table of ContentsWarning Letters. A charge of $28 million to recognize our currently estimated liability for future costs expected to be incurred to address the non-conformities identified in the Dispensing Warning Letter was recorded to Cost of products sold for the three-month period and fiscal year ended September 30, 2024. The charge, which is included in the “Specified Items” section below, impacted our financial results for the fiscal year ended September 30, 2024, included in this Annual Report on Form 10-K, as follows:
• Cost of product sold (from $11.025 billion reported in the Earnings Release to $11.053 billion);
• Operating Income (from $2.425 billion reported in the Earnings Release to $2.397 billion);
• Net Income from Continuing Operations (from $1.726 billion reported in the Earnings Release to $1.705 billion); and
• Diluted Earnings per Share from Continuing Operations (from $5.93 reported in the Earnings Release to $5.86).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.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 2023 primarily reflected the following.
• Strong global sales of catheters and other vascular care products in the Medication Delivery Solutions unit were partially offset by the impact of VoBP in China and lower COVID vaccination-related revenues in 2023 compared with these revenues in 2022.
• Strong performance of the Medication Management Solutions unit’s pharmacy automation portfolio, including Parata Systems, which we acquired in fiscal year 2022, and our BD Rowa™ technologies, as well as strong growth in sales of dispensing systems. Revenue growth attributable to the unit’s recent acquisitions was approximately 9.3% in 2023.
37Table of Contents• Continued strong demand for the Pharmaceutical Systems unit’s prefillable solutions in high-growth markets such as the biologic drug category.Medical segment operating income was as follows:(Millions of dollars) 2024 2023 2022
Medical segment operating income $ 2,742 $ 1,967 $ 2,215
Segment operating income as % of Medical revenues 27.2 % 20.7 % 25.1 %
The Medical segment's operating income as a percentage of revenues in 2024 and 2023, compared with the prior-year periods, reflected the following:
• The Medical segment’s higher gross profit margin in 2024 compared with 2023 primarily reflected the following:
◦ A favorable comparison to gross margin in 2023, which was impacted by $653 million of charges related to estimated future costs associated with the Medication Management Solutions unit’s remediation efforts related to Alaris TM infusion pumps, as well as lower manufacturing costs, which resulted from continuous improvement projects and other productivity initiatives that enhanced the efficiency of our operations; partially offset by
◦ An unfavorable impact of $59 million due to a fair value step-up adjustment relating to Advanced Patient Monitoring's inventory on the acquisition date, higher raw material and labor costs, as well as unfavorable foreign currency translation.
• The Medical segment’s lower gross profit margin in 2023 compared with 2022 primarily reflected the following:
◦ The $653 million of charges noted above related to product remediation efforts compared with charges in 2022 related to the same efforts of $72 million. The fiscal year 2023 charge impacted gross margin by approximately 6.9%.
◦ Higher raw material, labor and freight costs, as well as unfavorable foreign currency translation; partially offset by
◦ Lower manufacturing costs resulting from continuous improvement projects and pricing.
• Lower selling and administrative expense as a percentage of revenues in 2024 compared with 2023 primarily reflected revenue growth that outpaced spending and lower shipping costs. Selling and administrative expense as a percentage of revenues in 2023 was lower compared with 2022 due to lower selling and shipping costs.
• Research and development expense as a percentage of revenues in 2024 was lower compared with 2023, and in 2023 compared with 2022, which reflected revenue growth that outpaced project spending.
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Table of ContentsLife Sciences Segment
The following summarizes Life Sciences 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
Integrated Diagnostic Solutions $ 3,679 $ 3,624 $ 4,185 1.5 % (0.1) % 1.6 % (13.4) % (2.0) % (11.4) %
Biosciences 1,512 1,509 1,379 0.2 % — % 0.2 % 9.4 % (2.2) % 11.6 %
Total Life Sciences revenues $ 5,191 $ 5,133 $ 5,564 1.1 % — % 1.1 % (7.8) % (2.1) % (5.7) %
The Life Sciences segment’s revenue growth in 2024 primarily reflected the following:
• Strong growth in sales of the Integrated Diagnostic Solutions unit’s specimen management portfolio, partially offset by an unfavorable comparison to higher respiratory testing revenues in 2023, including COVID-19-only diagnostic testing revenues.• Strong demand for the Biosciences unit’s clinical reagents, offset by a decline in sales of the unit’s instrumentation due to a decline in life science research funding, primarily in the United States and China.The Life Sciences segment's revenues in 2023 primarily reflected the following:
• Revenues related to COVID-19-only diagnostic testing on the BD Veritor TM Plus and BD Max TM Systems in the Integrated Diagnostic Solutions unit of $73 million compared with revenues in 2022 of $511 million and an unfavorable comparison to stronger sales in 2022 of the Integrated Diagnostic Solutions unit’s combination influenza/COVID-19 testing assays, as well as destocking of specimen management products by U.S. distributors in 2023; partially offset by
• Growth in the Integrated Diagnostic Solutions unit’s microbiology platform and growth attributable to molecular diagnostic platforms which leveraged our larger installed base of BD MAX TM instruments.
• Strong growth in sales of the Biosciences unit’s reagents and instruments, including recently launched research instruments.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:
39Table 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. Lower selling and administrative expense as a percentage of revenues in 2023 compared with 2022 primarily reflected lower selling costs and efforts to contain certain administrative costs.
• Lower research and development expense as a percentage of revenues in 2024 compared with 2023 primarily reflected the progression of current projects. Higher research and development expense as a percentage of revenues in 2023 compared with 2022, primarily reflected the decline in segment revenues in 2023 compared with the prior-year period.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 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.
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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.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.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. revenues in 2023 were unfavorably impacted by a decline in COVID-19-only diagnostic testing sales compared with 2022, as discussed further above.
International revenue growth in 2024 was driven by the Medical segment’s Pharmaceutical Systems unit, the Life Sciences segment’s Integrated Diagnostic Solutions unit and the Interventional segment’s Peripheral Intervention unit. 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. Financial Statements and Supplementary Data.
41Table of ContentsInternational 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 Peripheral Intervention units. International revenues in 2023 were unfavorably impacted by a decline in COVID-19-only diagnostic testing sales compared with 2022, as discussed further above.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 revenue growth in 2023 was primarily driven by sales in Latin America, South Asia, and in China, despite unfavorable impacts to China revenues from volume-based procurement programs.Specified ItemsReflected in the financial results for 2024, 2023 and 2022 were the following specified items:
(Millions of dollars) 2024 2023 2022Integration costs (a)$ 23 $ 67 $ 68Restructuring costs (a)387 239 123Transaction costs (b)48 — —
Financing costs (b)
(8) — —Separation-related items (c)13 14 20Purchase accounting adjustments (d)1,503 1,434 1,431Product, litigation, and other items (e)346 554 268European 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.(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.
(d) Includes amortization and other adjustments related to the purchase accounting for acquisitions. BD’s amortization expense is recorded in Cost of products sold .
(e) Includes certain (income) expense items which are not part of ordinary operations and affect the comparability of the periods presented. Such items may include certain product remediation costs, certain product liability and legal defense costs, certain investment gains and losses, certain asset impairment charges, and certain pension settlement costs. The amount in 2024 was primarily recorded to Revenues
42Table of Contentsand Other operating expense (income), net , and largely related to legislative and legal matters, as further discussed above in our geographic revenue discussion and further below in our discussion of Other operating expense (income), net . 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. 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. The amount in 2022 also includes a charge of $54 million related to a noncash asset impairment, which was recorded to Cost of products sold. The amounts in 2023 and 2022 additionally include certain amounts recorded to Other operating expense (income), net , which are detailed further below.(f) Represents costs incurred to develop processes and systems to establish initial compliance with the European Union Medical Device Regulation and the European Union In Vitro Diagnostic Medical Device Regulation, which represent a significant, unusual change to the existing regulatory framework. We consider these costs to be duplicative of previously incurred costs and/or one-off costs, which are limited to a specific period of time. These expenses, which are recorded in Cost of products sold and Research and development expense , include the cost of labor, other services and consulting (in particular, research and development and clinical trials) and supplies, travel and other miscellaneous costs.
Gross Profit MarginThe 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.
The impact of other specified items on gross margin in 2023 compared with 2022 reflected the $653 million of charges recorded in 2023 as noted above related to product remediation efforts, compared with charges in 2022 related to the same efforts of $72 million. The impact of other specified item in 2023 compared with 2022 additionally reflected a non-cash asset impairment charge of $54 million recorded by the Medical segment in 2022.
Operating performance in 2024 and 2023 reflected lower manufacturing costs resulting from our ongoing continuous improvement projects and other productivity initiatives, as well as a favorable impact from pricing. 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 2023 was unfavorably impacted by higher raw material, labor and freight costs.
43Table of ContentsOperating ExpensesOperating 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) $ 37Selling and administrativeSelling 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.
Lower selling and administrative expense as a percentage of revenues in 2023 compared with 2022 primarily reflected higher revenues in 2023 and favorable foreign currency translation, partially offset by higher selling costs in 2023, as well as an increase in our deferred compensation plan liability due to market performance. The investment gains on deferred compensation plan assets were recorded to Other expense, net .Research and developmentLower 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. Spending in 2024, 2023 and 2022 reflected our continued commitment to invest in new products and platforms.Integration, restructuring and transaction expenseIntegration expense in 2024, 2023 and 2022 primarily included costs related to system integrations and our 2022 acquisition of Parata Systems. 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. 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. Financial Statements and Supplementary Data:
44Table 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) $ 37Net 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. 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.
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.Income TaxesThe 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. 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.
45Table of ContentsNet Income and Diluted Earnings per Share from Continuing OperationsNet 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) $ 0.14Financial 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. The counterparties to these contracts are highly rated financial institutions. We do not enter into financial instruments for trading or speculative purposes. Additional disclosures regarding our derivative instruments are provided in Note 14 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Foreign Exchange RiskBD and its subsidiaries transact business in various foreign currencies throughout Europe, Greater Asia, Canada and Latin America. We face foreign currency exposure from the effect of fluctuating exchange rates on payables and receivables relating to transactions that are denominated in currencies other than our functional currency. These payables and receivables primarily arise from intercompany transactions. We hedge substantially all such exposures, primarily through the use of forward contracts. We have also hedged the currency exposure associated with investments in certain foreign subsidiaries with instruments such as foreign currency-denominated debt and cross-currency swaps, which are designated as net investment hedges, as well as currency exchange contracts. In order to mitigate transactional foreign currency exposures resulting from anticipated intercompany purchases and sales, we have hedged a portion of this currency risk with certain instruments such as foreign exchange forward and option contracts, which are designated as cash flow hedges. 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.Derivative financial instruments are recorded on our balance sheet at fair value. For foreign currency derivatives, market risk is determined by calculating the impact on fair value of an assumed change in foreign exchange rates relative to the U.S. dollar. Fair values were estimated based upon observable inputs, specifically spot currency rates and foreign currency prices for similar assets and liabilities.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 $ 100These 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.46Table of Contents
Interest Rate Risk
When managing interest rate exposures, we strive to achieve an appropriate balance between fixed and floating rate instruments. We may enter into interest rate swaps to help maintain this balance and manage debt and interest-bearing investments in tandem, since these items have an offsetting impact on interest rate exposure. For interest rate derivative instruments, fair values are measured based upon the present value of expected future cash flows using market-based observable inputs including credit risk and interest rate yield curves. Market risk for these instruments is determined by calculating the impact to fair value of an assumed change in interest rates across all maturities.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 ResourcesOur 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. We believe that our available cash and cash equivalents, our ability to generate operating cash flow, and if needed, our access to borrowings from our financing facilities provide us with sufficient liquidity to satisfy our foreseeable operating needs. 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 ActivitiesCash 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. This net source of cash primarily reflected higher levels of accounts payable and accrued expenses, as well as lower levels of inventory, which reflects our continued efforts to optimize inventory levels, partially offset by higher levels of trade receivables. Cash flows from operating activities in 2024 additionally reflected a discretionary cash contribution of $150 million to fund our pension obligation.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. 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. This net use of cash primarily reflected higher levels
47Table of Contentsof inventory and prepaid expenses, as well as lower levels of accounts payable and accrued expenses. Cash flows from continuing operating activities in 2022 additionally reflected a discretionary cash contribution of $134 million to fund our pension obligation.
Net Cash Flows from Continuing Investing ActivitiesCapital expendituresOur 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. 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.AcquisitionsCash outflows for acquisitions in 2024 was attributable to the acquisition of Advanced Patient Monitoring in the fourth quarter of 2024. Cash outflows for acquisitions in 2022 reflected consideration of $1.548 billion associated with our acquisition of Parata Systems in the fourth quarter of 2022, as well as cash payments relating to various strategic acquisitions we have executed as part of our growth strategy, including our acquisitions of MedKeeper, Scanwell Health, Inc, Tissuemed, Ltd., and Venclose, Inc.Divestitures
Cash inflows relating to our divestiture of the Interventional segment's Surgical Instrumentation platform in 2023 were $540 million. For further discussion, refer to Note 2 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.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 2022Cash 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. (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. Financial Statements and Supplementary Data.
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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.
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 InvestmentsAt 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. We regularly review the amount of cash and short-term investments held outside of the United States and our historical foreign earnings are used to fund foreign investments or meet foreign working capital and property, plant and equipment expenditure needs. 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 FacilitiesWe have a senior unsecured revolving credit facility in place which will expire in September 2027. 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 that we may, subject to additional commitments by lenders, request an additional $500 million of financing, for a maximum aggregate commitment under the credit facility of up to $3.250 billion. 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.
The agreement for our revolving credit facility contains the following financial covenants. 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 may access commercial paper programs over the normal course of our business activities. Our U.S. and multicurrency euro commercial paper programs provide for a maximum amount of unsecured borrowings under the two programs, in aggregate, of $2.750 billion. 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. Also, over the normal course of our business activities, we transfer certain trade receivable assets to third parties under factoring agreements. Additional disclosures regarding sales of trade receivable assets are provided in Note 15 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
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Access to Capital and Credit RatingsOur 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 StableOur corporate credit ratings at September 30, 2024 were unchanged compared with our ratings at September 30, 2023.Lower corporate debt ratings and downgrades of our corporate credit ratings or other credit ratings may increase our cost of borrowing. We believe that given our debt ratings, our financial management policies, our ability to generate cash flow and the diversified nature of our businesses, we would have access to additional short-term and long-term capital should the need arise. A rating reflects only the view of a rating agency and is not a recommendation to buy, sell or hold securities. Ratings can be revised upward or downward at any time by a rating agency if such rating agency decides that circumstances warrant such a change.
Contractual Obligations
In the normal course of business, we enter into contracts and commitments that obligate us to make payments in the future. Information regarding our obligations under purchase, debt and lease arrangements are provided in Notes 6, 16 and 18, respectively, to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Critical Accounting Estimates
The following discussion supplements the descriptions of our accounting policies contained in Note 1 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. The preparation of the consolidated financial statements requires management to use estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, as well as the disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Some of those judgments can be subjective and complex and, consequently, actual results could differ from those estimates. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. For any given estimate or assumption made by management, it is possible that other people applying reasonable judgment to the same facts and circumstances could develop different estimates. Actual results that differ from management’s estimates could have an unfavorable effect on our consolidated financial statements. Management believes the following policy areas require more significant judgment:
Revenue RecognitionOur revenues are primarily recognized when the customer obtains control of the product sold, which is generally upon shipment or delivery, depending on the delivery terms specified in the sales agreement. Revenues associated with certain instruments and equipment for which installation is complex, and therefore significantly affects the customer’s ability to use and benefit from the product, are recognized when customer acceptance of these installed products has been confirmed. For leases and for certain service arrangements, including extended warranty and software maintenance contracts, revenue is recognized ratably over the contract term. The majority of revenues relating to extended warranty contracts associated with certain
50Table of Contentsinstruments and equipment is generally recognized within a few years whereas deferred revenue relating to software maintenance contracts is generally recognized over a longer period.
Our agreements with customers within certain organizational units including Medication Management Solutions, Integrated Diagnostic Solutions and Biosciences, contain multiple performance obligations including both products and certain services noted above. 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 generally estimate standalone selling prices using list prices and a consideration of typical discounts offered to customers. 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. Additional factors considered in the estimate of our rebate liability include the quantification of inventory that is either in stock at or in transit to our distributors, as well as the estimated lag time between the sale of product and the payment of corresponding rebates.Impairment of Assets
Goodwill assets are subject to impairment reviews at least annually, or whenever indicators of impairment arise. Intangible assets with finite lives, including developed technology, and other long-lived assets, are periodically reviewed for impairment when impairment indicators are present.We assess goodwill for impairment at the reporting unit level, which is defined as an operating segment or one level below an operating segment, referred to as a component. Our reporting units represent one level below reporting segments. 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.
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 selected this method because we believe the income approach most appropriately measures the value of our income producing assets. This approach requires significant management judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, appropriate discount rates, terminal values and other assumptions and estimates. The estimates and assumptions used are consistent with BD’s business plans. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of the asset. Actual results may differ from management’s estimates.Income Taxes
BD maintains valuation allowances where it is more likely than not that all or a portion of a deferred tax asset will not be realized. Changes in valuation allowances are included in our tax provision in the period of change. In determining whether a valuation allowance is warranted, management evaluates factors such as prior earnings history, expected future earnings, carryback and carryforward periods, and tax strategies that could potentially enhance the likelihood of realization of a deferred tax asset.BD conducts business and files tax returns in numerous countries and currently has tax audits in progress in a number of tax jurisdictions. In evaluating the exposure associated with various tax filing positions, we record accruals for uncertain tax positions based on the technical support for the positions, our past audit experience with similar situations, and the potential interest and penalties related to the matters. BD’s effective tax rate in any given period could be impacted if, upon resolution with taxing authorities, we prevailed in
51Table of Contentspositions for which reserves have been established, or we were required to pay amounts in excess of established reserves.
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. 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.ContingenciesWe 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. 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. 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. The accruals may change in the future as new information for an individual matter becomes available or due to changes in our litigation strategy. We record expected recoveries, up to the amount of loss recognized, from product liability insurance carriers or other parties when realization of recovery is deemed probable.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.Benefit PlansWe have significant net pension and other postretirement and postemployment benefit obligations and costs that are measured using actuarial valuations which include assumptions for the discount rate and the expected return on plan assets. These assumptions have a significant effect on the amounts reported. In addition to the analysis below, see Note 10 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data for additional discussion.
The discount rate is selected each year based on investment grade bonds and other factors as of the measurement date (September 30). 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. 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. 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. The expected long-term rate of return on plan assets assumption, although reviewed each year, changes less frequently due to the long-term nature of the assumption. This assumption does not impact the measurement of assets or liabilities as of the measurement date; rather, it is used only in the calculation of pension expense. To determine the expected long-term rate of return on pension plan assets, we consider many factors, including our historical assumptions compared with actual results; benchmark data; expected returns on various plan asset classes, as well as current and expected asset allocations. We will use a long-term expected rate of return on
52Table of Contentsplan 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.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. This estimate assumes no change in the shape or steepness of the company-specific yield curve used to plot the individual spot rates that will be applied to the future cash outflows for future benefit payments in order to calculate interest and service cost.• Expected return on plan assets — A change of plus (minus) 25 basis points, with other assumptions held constant, would have an estimated $4 million favorable (unfavorable) impact on U.S. pension plan costs.
Cautionary Statement Regarding Forward-Looking StatementsThis 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. Forward-looking statements may be identified by the use of words such as “plan,” “expect,” “believe,” “intend,” “will,” “may,” “anticipate,” “estimate” and other words of similar meaning in conjunction with, among other things, discussions of future operations and financial performance (including volume growth, pricing, sales and earnings per share growth, and cash flows) and statements regarding our strategy for growth, liquidity, future product development, regulatory approvals, competitive position and expenditures. All statements that address our future operating performance or events or developments that we expect or anticipate will occur in the future are forward-looking statements.Forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events, developments and operating performance, and speak only as of their dates. Investors should realize that if underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results could vary materially from our expectations and projections. Investors are therefore cautioned not to place undue reliance on any forward-looking statements. Furthermore, we undertake no obligation to update or revise any forward-looking statements after the date they are made, whether as a result of new information, future events and developments or otherwise, except as required by applicable law or regulations.
The following are some important factors that could cause our actual results to differ from our expectations in any forward-looking statements. For further discussion of certain of these factors, see Item 1A. 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.
53Table 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. Our international operations also increase our compliance risks, including risks under the Foreign Corrupt Practices Act and other anti-corruption and bribery laws, as well as regulatory and privacy laws.
• Cost-containment efforts in the U.S. or in other countries in which we do business, such as alternative payment reform, government-imposed pay back provisions, increased use of competitive bidding and tenders, including, without limitation, any expansion of the volume-based procurement process in China or the implementation of similar cost-containment efforts.
• Competitive factors that could adversely affect our operations, including new product introductions and technologies, including the use of artificial intelligence, by our current or future competitors, consolidation or strategic alliances among healthcare companies, distributors and/or payers of healthcare to improve their competitive position or develop new models for the delivery of healthcare, increased pricing pressure due to the impact of low-cost manufacturers, patents attained by competitors (particularly as patents on our products expire), new entrants into our markets and changes in the practice of medicine.• Changes in the way healthcare services are delivered, including transition of more care from acute to non-acute settings and increased focus on chronic disease management, which may affect the demand for our products and services. Additionally, budget constraints and staffing shortages, particularly shortages of nursing staff, may affect the prioritization of healthcare services, which could also impact the demand for certain of our products and services.
• Our ability to achieve our projected level or mix of product sales, as our earnings forecasts are based on projected sales volumes and pricing of many product types, some of which are more profitable than others.• Changes in coverage policies or reimbursement levels, or adverse decisions relating to our products and services by governments or third-party payers, which could reduce demand for our products or the price we can charge for such products.
• Product efficacy or safety concerns or non-compliance with applicable regulatory requirements regarding our products (such as non-compliance of our products with registration requirements resulting from modifications to such products, or other factors, including, but not limited to, with respect to BD Alaris™ pumps and related sets and BD Vacutainer TM ) resulting in product recalls, lost revenue or other actions being taken with respect to products in the field or the ability to continue selling new products to customers (including restrictions on future product clearances and civil penalties), product liability or other claims and damage to our reputation. As a result of the CareFusion acquisition, our U.S. infusion pump business is operating under a Consent Decree with the FDA. The Consent Decree authorizes the FDA, in the event of any violations in the future, to order our U.S. infusion pump business to cease manufacturing and distributing products, recall products or take other actions, and order the payment of significant monetary damages if the business subject to the decree fails to comply with any provision of the Consent Decree. In accordance with our commitments to the FDA, the overall timing of replacement or remediation of the BD Alaris™ Infusion Systems and return to market in the U.S. may be impacted by, among other things, customer readiness, supply continuity and our continued engagement with the FDA.
• Changes in the domestic and foreign healthcare industry, in medical practices or in patient preferences that result in a reduction in procedures using our products or increased pricing pressures, including cost-reduction measures instituted by and the continued consolidation among healthcare providers.
54Table of Contents• The effects of regulatory or other events (such as public health crises) that adversely impact our supply chain, including our ability to manufacture (including sterilize) our products (particularly where production of a product line or sterilization operations are concentrated in one or a few plants), source materials or components or services from suppliers (including sole-source suppliers) that are needed for such manufacturing (including sterilization), or provide products to our customers, including events that impact key distributors. 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. Delays in obtaining necessary approvals or clearances from the FDA or other regulatory agencies or changes in the regulatory process may also delay product launches and increase development costs.
• The impact of changes in U.S. federal or foreign laws and policies that could affect fiscal and tax policies, taxation (including tax reforms, such as the implementation of a global minimum tax, that could adversely impact multinational corporations), and international trade, including import and export regulation and international trade agreements. In particular, tariffs, sanctions or other trade barriers imposed by the U.S. or other countries could adversely impact our supply chain costs or otherwise adversely impact our results of operations.
• Deficit reduction efforts or other actions that reduce the availability of government funding for healthcare and research, which could weaken demand for our products and result in additional pricing pressures, as well as create potential collection risks associated with such sales.
• Fluctuations in university or U.S. and international governmental funding and policies for life sciences research.• 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.• Any impact that public health crises, such as pandemics and epidemics may have on our business, the global economy and the global healthcare system. 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. In particular, the U.S. and other countries may impose new requirements regarding registration, labeling or prohibited materials that may require us to re-register products already on the market or otherwise impact our ability to market our products. 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.
The foregoing list sets forth many, but not all, of the factors that could impact our ability to achieve results described in any forward-looking statements. 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.56Table of Contents
FY 2025-09-30 (later)
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following commentary should be read in conjunction with the consolidated financial statements and accompanying notes presented in this report. Within the tables presented throughout this discussion, certain columns may not add due to the use of rounded numbers for disclosure purposes. Percentages and earnings per share amounts presented are calculated from the underlying amounts. References to years throughout this discussion relate to our fiscal years, which end on September 30.
Company Overview
Description of the Company and Business Segments
Becton, Dickinson and Company (“BD”) is a global medical technology company engaged in the development, manufacture and sale of a broad range of medical supplies, devices, laboratory equipment and diagnostic products used by healthcare institutions, physicians, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. The Company's organizational structure is based upon three principal business segments, BD Medical (“Medical”), BD Life Sciences (“Life Sciences”) and BD Interventional (“Interventional”).
BD’s products are manufactured and sold worldwide. Our products are marketed in the United States and internationally through independent distribution channels and directly to end-users by BD and independent sales representatives. We organize our operations outside the United States as follows: EMEA (which includes Europe, the Middle East and Africa); Greater Asia (which includes countries in Greater China, Japan, South Asia, Southeast Asia, Korea, Australia and New Zealand); Latin America (which includes Mexico, Central America, the Caribbean and South America); and Canada. 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. Financial Statements and Supplementary Data, effective October 1, 2025, we reorganized our organizational units into five distinct, separately-managed segments, based on the nature of our product and service offerings. 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”) is completed. Additional disclosures regarding the agreement to combine our Biosciences and Diagnostic Solutions business with Waters are provided in Note 1 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.Strategic ObjectivesBD remains focused on delivering durable growth, creating shareholder value and making appropriate investments for the future. Our strategy is anchored in three key pillars: grow, simplify and empower. 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.
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.
Empower
• Fostering a purpose-driven culture with a focus on positive impact to all stakeholders–customers, patients, employees, shareholders and communities;
• Cultivating an inclusive work environment that welcomes and celebrates diverse backgrounds and perspectives;
• Growing and enabling talent through training, development and reskilling strategies; and
• Driving sustainability initiatives within our organizational units to support enterprise-wide collaboration towards our sustainability strategy.
In assessing the outcomes of these strategies as well as BD’s financial condition and operating performance, management generally reviews forecast data, monthly actual results, including segment sales, and other similar information. 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. Financial Statements and Supplementary Data, we entered into a definitive agreement on July 13, 2025 to combine our Biosciences and Diagnostic Solutions business with Waters in a transaction that is expected to create an innovative life science and diagnostics leader with pioneering technologies.
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Table of ContentsAcquisition of Edwards Lifesciences’ Critical Care Product GroupOn September 3, 2024, we completed the acquisition of Edwards Lifesciences’ Critical Care product group, which we renamed as BD Advanced Patient Monitoring (“Advanced Patient Monitoring”), for total consideration of $3.914 billion. Advanced Patient Monitoring is a global leader in advanced monitoring solutions that expands BD’s portfolio of smart connected care solutions with its growing set of leading monitoring technologies, advanced AI-enabled clinical decision tools and robust innovation pipeline that complement our existing technologies serving operating rooms and intensive care units.
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.
BD’s DivestituresIn 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. 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.
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.
We have been experiencing, and may continue to experience, some adverse impact to our results of operations due to market dynamics in China, such as volume-based procurement programs (“VoBP”) and the government’s focus to improve compliance of healthcare practitioners. Also, reductions or delays in governmental research funding has caused customers for certain of our instruments to delay or forgo purchases of these products. Lower demand for vaccines has also adversely impacted our results of operations. The future demand for our products and services could be impacted by other factors including higher interest rates and the deterioration of healthcare systems’ budgets.
Additionally, 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. In general, major disruptions in the sourcing, manufacturing and distribution of our products could adversely impact our results of operations. Also, tariffs, sanctions or other trade barriers imposed by the United States, or against the United States from countries in which we do business, could adversely impact our supply chain costs, results of operations and our financial condition. Based upon the latest published tariffs that are currently in effect, we expect tariffs to adversely impact our operating expense for fiscal year 2026 and potentially beyond, primarily relating to any products (or components) imported from countries across our global supply chain which have no exemption opportunities. We continue to monitor international trade policy-related developments to assess their potential impacts to our operations. The ultimate impact of any existing or new tariffs or other changes in international trade policies is subject to a number of factors including, but not limited to, the duration of such tariffs, changes in tariff rates, the amount, scope and nature of the tariffs, any countermeasures that target countries may take, or any mitigating actions that may become available. While sourcing optimization and tariff exemptions for qualifying products are key
37Table of Contentsaspects of our mitigation strategy, the timing of such or the ultimate results we will realize from these efforts are uncertain. In addition, our tariff mitigation strategies may be challenged, rejected or eliminated through legislation or other challenges, or may otherwise not be effective.We continue to invest in research and development, strategic tuck-in acquisitions, geographic expansion, and new product programs to drive further revenue and profit growth. Our ability to sustain our long-term growth will depend on a number of factors, including our ability to expand our core business (including strategic geographical expansion), and develop innovative new products, as well as continue to improve operating efficiency and organizational effectiveness.For additional information on risk factors that may impact our business, results of operations, financial condition and cash flows, see Part I, Item 1A. Risk Factors.Summary of Financial ResultsWorldwide revenues in 2025 of $21.840 billion increased 8.2% from the prior-year period. This increase reflected the following impacts:Increase (decrease) in current-year revenuesVolume/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 period8.2 %(a) Volume/other includes revenues attributable to products, services and licensing.(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. Financial Statements and Supplementary Data.
Cash flows from continuing operating activities were $3.430 billion in 2025. At September 30, 2025, we had $859 million in cash and equivalents and short-term investments, including restricted cash. We continued to return value to our shareholders in the form of dividends and during fiscal year 2025, we paid cash dividends to common shareholders of $1.196 billion.We also repurchased approximately $1 billion of our common stock during fiscal year 2025.
Each reporting period and given our worldwide operations, we face exposure to our results of operations from changes in foreign currencies. 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. 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. 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. We use results on a foreign currency-neutral basis as one measure to evaluate our performance. These results should be considered in addition to, not as a substitute for, results reported in accordance with U.S. generally accepted accounting
38Table of Contentsprinciples (“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 of OperationsMedical 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 Medical segment’s revenue growth in 2025 primarily reflected the following.
• Volume growth attributable to the Medication Delivery Solutions unit’s Vascular Access Management portfolio and hypodermic products, partially offset by an expected VoBP impact in China.
• Growth in the Medication Management Solutions unit driven by continued strength in sales of infusion systems, partially offset by the timing of dispensing and pharmacy automation installations, based upon customer readiness, in the current year.
• Growth in the Pharmaceutical Systems unit due to high single-digit growth of prefillable solutions in the biologic drug category, partially offset by lower market demand for other product categories.
• Overall Medical segment revenue growth also reflected sales in the Advanced Patient Monitoring unit, which we acquired during the fourth quarter of fiscal year 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, 2024.39Table of ContentsMedical 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.
The Medical segment's operating income as a percentage of revenues in 2025 and 2024, compared with the prior-year periods, reflected the following:
• Higher gross profit margin in 2025 compared with 2024 primarily reflected lower manufacturing costs, which resulted from continuous improvement projects, supply chain optimization and other productivity initiatives, as well as favorable product mix which was attributable to the Advanced Patient Monitoring unit’s products, partially offset by tariffs and higher labor costs.
• The Medical segment’s gross profit margin in 2024 was flat compared with 2023 and primarily reflected lower manufacturing costs, which resulted from the productivity initiatives noted above, offset by higher raw material and labor costs, as well as unfavorable foreign currency translation.
• Higher selling and administrative expense as a percentage of revenues in 2025 compared with 2024 primarily reflected costs attributable to the Advanced Patient Monitoring unit. Lower selling and administrative expense as a percentage of revenues in 2024 compared with 2023 primarily reflected revenue growth that outpaced spending and lower shipping costs.
• Higher research and development expense as a percentage of revenues in 2025 compared with 2024 which primarily reflected costs attributable to the Advanced Patient Monitoring unit, offset by the timing of project spending. Research and development expense as a percentage of revenues in 2024 was lower compared with 2023, which reflected revenue growth that outpaced project spending.Life Sciences Segment
The following summarizes Life Sciences 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
Specimen Management (a) $ 1,871 $ 1,833 $ 1,737 2.0 % (0.1) % 2.1 % 5.6 % 0.1 % 5.5 %
Diagnostic Solutions (a) 1,838 1,846 1,888 (0.4) % 0.3 % (0.7) % (2.2) % (0.1) % (2.1) %
Biosciences 1,458 1,512 1,509 (3.6) % 0.4 % (4.0) % 0.2 % — % 0.2 %
Total Life Sciences revenues $ 5,167 $ 5,191 $ 5,133 (0.5) % 0.1 % (0.6) % 1.1 % — % 1.1 %
(a) During the first quarter of fiscal year 2025, Life Sciences split its former Integrated Diagnostic Solutions organizational unit into two units to better align BD resources with the distinct needs of each business.
The Life Sciences segment’s revenue growth in 2025 primarily reflected the following:
• Growth in the Specimen Management unit’s BD Vacutainer TM portfolio, partially offset by a decline in China.
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• A decline in the Diagnostic Solutions unit driven by lower sales of BD BACTEC TM blood culture products as customer utilization continues to improve following the resolution of a supply disruption, as well as by lower sales of point-of-care products, partially offset by continued double-digit growth in sales of BD MAX TM IVD.
• A decline in the Biosciences unit due to continued market dynamics impacting sales of instruments, partially offset by strong sales of the recently launched BD FACSDiscover TM A8 Cell Analyzer.
The Life Sciences segment's revenues in 2024 primarily reflected the following:
• Sales driven by broad volume growth attributable to the Specimen Management unit’s portfolio.
• A decline in the Diagnostic Solutions unit driven by an unfavorable comparison to higher respiratory testing revenues in 2023, including COVID-19-only diagnostic testing revenues.• Strong demand for the Biosciences unit’s clinical reagents, offset by a decline in sales of the unit’s instrumentation due to a decline in life science research funding, primarily in the United States and China.Life Sciences segment operating income was as follows:(Millions of dollars) 2025 2024 (a) 2023 (a)
Life Sciences segment operating income $ 1,641 $ 1,616 $ 1,599
Segment operating income as % of Life Sciences revenues 31.8 % 31.1 % 31.2 %
(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.
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. Selling 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.
41Table of ContentsInterventional 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.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.42Table 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. Financial Statements and Supplementary Data.
The Interventional segment's operating income as a percentage of revenues in 2025 and 2024, compared with the prior-year periods, reflected the following:
• The Interventional segment’s higher gross profit margin in 2025 compared with 2024 primarily reflected lower manufacturing costs resulting from continuous improvement projects, supply chain optimization and other productivity initiatives, partially offset by unfavorable impacts from tariffs, as well as higher labor and raw material costs.• The Interventional segment’s higher gross profit margin in 2024 compared with 2023 primarily reflected favorable impacts from product mix and pricing.• Selling and administrative expense as percentages of revenues in 2025 was flat compared with 2024. Higher research and development expense as a percentage of revenues in 2025 compared with 2024 primarily reflected the timing of project spending.
• Lower selling and administrative expense, as well as research and development expense, as percentages of revenues in 2024 compared with 2023, primarily reflected revenue growth that outpaced spending.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. 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.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.International revenue growth in 2025 was largely driven by the acquired Advanced Patient Monitoring unit’s sales. International revenue growth was also driven by sales in the Medical segment’s Medication Delivery Solutions unit, as well as by sales in all of the Interventional segment’s units. International revenue
43Table of Contentsgrowth also reflected a favorable comparison to the prior-period, which was unfavorably impacted by $62 million of accruals related to the Italian government medical device pay back legislation, as further discussed above. International revenue growth in 2025 was partially offset by a decline in the Life Sciences segment’s Biosciences unit, as further discussed above.
International revenue growth in 2024 was driven by the Medical segment’s Pharmaceutical Systems unit, the Life Sciences segment’s Specimen Management and Diagnostic Solutions units and the Interventional segment’s Peripheral Intervention unit. International revenue growth in 2024 also reflected the unfavorable impact of a $62 million accrual related to the Italian government medical device pay back legislation, as noted above. Additional disclosures regarding this matter are provided in Note 6 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.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. Emerging market revenue growth in 2025 also reflected strong sales in EMA. Emerging market revenue growth in 2025 and 2024 was partially offset by declines in China, as further discussed above.Specified ItemsReflected in the financial results for 2025, 2024 and 2023 were the following specified items:
(Millions of dollars) 2025 2024 2023Integration costs (a)$ 127 $ 23 $ 67Restructuring costs (a)275 387 239Transaction costs (b)6 48 —
Financing impacts (b)
— (8) —Separation-related items (c)97 13 14Purchase accounting adjustments (d)1,898 1,503 1,434Product, litigation, and other items (e)548 346 554European 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.(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 proposed combination of our Biosciences and Diagnostic Solutions business with Waters, as well as with the fiscal year 2022 separation of BD's former Diabetes Care business.
(d) Includes amortization and other adjustments related to the purchase accounting for acquisitions. BD’s amortization expense is recorded in Cost of products sold . The amount in 2025 also includes
44Table of Contents$336 million recorded due to a fair value step-up adjustment relating to Advanced Patient Monitoring's inventory on the acquisition date.
(e) Includes certain (income) expense items which are not part of ordinary operations and affect the comparability of the periods presented. Such items may include certain product remediation costs, amounts related to certain legal matters, certain investment gains and losses, certain asset impairment charges, and certain pension settlement costs. The amounts presented include the following:
• The amounts in 2025, 2024 and 2023 included charges related to product liability and certain other legal matters which were recorded to Other operating expense (income), net as detailed further below. The amount in 2024 also reflected accruals related to legislative and legal matters that were recorded to Revenues , as further discussed above in our geographic revenue discussion. Additional disclosures regarding these legal and legislative matters are provided in Note 6 to the consolidated financial statements contained in Item 8. 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. Financial Statements and Supplementary Data .
• The amount in 2023 additionally included a gain of $268 million related to the sale of our Surgical Instrumentation platform recorded to Other operating expense (income), net.(f) Represents costs incurred to develop processes and systems to establish initial compliance with the European Union Medical Device Regulation and the European Union In Vitro Diagnostic Medical Device Regulation, which represent a significant, unusual change to the existing regulatory framework. We consider these costs to be duplicative of previously incurred costs and/or one-off costs, which are limited to a specific period of time. These expenses, which are recorded in Cost of products sold and Research and development expense , include the cost of labor, other services and consulting (in particular, research and development and clinical trials) and supplies, travel and other miscellaneous costs.
Gross Profit MarginThe 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.
45Table of ContentsThe 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.
Operating performance in 2025 primarily reflected lower manufacturing costs resulting from our ongoing continuous improvement projects, supply chain optimization and other productivity initiatives, partially offset by higher labor costs and tariffs. 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.Operating ExpensesOperating 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 administrativeSelling 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. 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 2024, partially offset by higher selling costs.Research and developmentResearch and development expense as a percentage of revenues in 2025 was flat compared with 2024, which primarily reflected the timing of project spending, offset by a $30 million write-down of certain assets in the Life Sciences segment in the current-year period which is further discussed in Note 15 to the consolidated financial statements contained in Item 8. 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.Integration, restructuring and transaction expenseThe amount in 2025 included integration, restructuring and transaction costs relating to our acquisition of the Advanced Patient Monitoring unit and the amount in 2024 included transaction costs, such as legal, advisory and other costs, relating to this acquisition. Integration expense in 2024 and 2023 additionally included costs related to system integrations. 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
46Table of Contentsrelating to restructurings, refer to Note 12 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
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. 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. 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. 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.Income TaxesThe 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. The higher effective income tax rate for continuing operations in 2024 compared with 2023 primarily reflected the unfavorable impact attributable to non-deductible costs recorded in 2024 and the recognition of more favorable discrete items in 2023. Additional disclosures regarding the effective tax rates in
47Table of Contents2025, 2024 and 2023 are provided in Note 17 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.Net Income and Diluted Earnings per Share from Continuing OperationsNet 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. The counterparties to these contracts are highly rated financial institutions. We do not enter into financial instruments for trading or speculative purposes. Additional disclosures regarding our derivative instruments are provided in Note 14 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Foreign Exchange RiskBD and its subsidiaries transact business in various foreign currencies throughout Europe, Greater Asia, Canada and Latin America. We face foreign currency exposure from the effect of fluctuating exchange rates on payables and receivables relating to transactions that are denominated in currencies other than our functional currency. These payables and receivables primarily arise from intercompany transactions. We hedge substantially all such exposures, primarily through the use of forward contracts. We have also hedged the currency exposure associated with investments in certain foreign subsidiaries with instruments such as foreign currency-denominated debt and cross-currency swaps, which are designated as net investment hedges, as well as currency exchange contracts. In order to mitigate transactional foreign currency exposures resulting from anticipated intercompany purchases and sales, we have hedged a portion of this currency risk with certain instruments such as foreign exchange forward and option contracts, which are designated as cash flow hedges. 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.Derivative financial instruments are recorded on our balance sheet at fair value. For foreign currency derivatives, market risk is determined by calculating the impact on fair value of an assumed change in foreign exchange rates relative to the U.S. dollar. Fair values were estimated based upon observable inputs, specifically spot currency rates and foreign currency prices for similar assets and liabilities.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 $ 147These 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.48Table of Contents
Interest Rate Risk
When managing interest rate exposures, we strive to achieve an appropriate balance between fixed and floating rate instruments. We may enter into interest rate swaps to help maintain this balance and manage debt and interest-bearing investments in tandem, since these items have an offsetting impact on interest rate exposure. For interest rate derivative instruments, fair values are measured based upon the present value of expected future cash flows using market-based observable inputs including credit risk and interest rate yield curves. Market risk for these instruments is determined by calculating the impact to fair value of an assumed change in interest rates across all maturities.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 ResourcesOur 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. We believe that our available cash and cash equivalents, our ability to generate operating cash flow, and if needed, our access to borrowings from our financing facilities provide us with sufficient liquidity to satisfy our foreseeable operating needs. 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 ActivitiesCash 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. This net use of cash primarily reflected higher levels of inventory and prepaid expenses, as well as lower levels of accrued expenses. The decrease in accrued expenses included our payment of $175 million relating to the SEC investigation as further discussed in Note 6 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.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. This net source of cash primarily reflected higher levels of accounts payable and accrued expenses, as well as lower levels of inventory, which reflects our continued efforts to optimize inventory levels, partially offset by higher levels of trade receivables. Cash flows from operating activities in 2024 additionally reflected a discretionary cash contribution of $150 million to fund our pension obligation.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
49Table of Contentsin 2022 due to efforts in 2023 to optimize inventory levels. 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.
Net Cash Flows from Investing ActivitiesCapital expendituresOur 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. Details of spending by segment are contained in Note 8 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Investments
Cash inflows from investing activities in 2025 included a $422 million net inflow attributable to the maturity of time deposits, compared with a $421 million outflow from investing activities in 2024 attributable to the net purchases of investments, primarily in time deposits.AcquisitionsCash 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.Divestitures
Cash inflows relating to our divestiture of the Interventional segment's Surgical Instrumentation platform in 2023 were $540 million. For further discussion, refer to Note 2 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.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 2023Cash 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. 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. Financial Statements and Supplementary Data.
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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.
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 InvestmentsAt 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. We regularly review the amount of cash and short-term investments held outside of the United States and our historical foreign earnings are used to fund foreign investments or meet foreign working capital and property, plant and equipment expenditure needs. 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 FacilitiesDuring the fourth quarter of fiscal year 2025, the Company refinanced its senior unsecured revolving credit facility that was to expire in September 2027, with a new senior unsecured revolving credit facility that will expire in September 2030. 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). The credit facility provides that we may, subject to additional commitments by lenders, request an additional $500 million of financing, for a maximum aggregate commitment under the credit facility of up to $3.250 billion. 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.
The agreement for our revolving credit facility contains the following financial covenants. 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.
We may access commercial paper programs over the normal course of our business activities. Our U.S. and multicurrency euro commercial paper programs provide for a maximum amount of unsecured borrowings under the two programs, in aggregate, of $2.750 billion. 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. Also, over the normal course of our business activities, we transfer certain trade receivable assets to third parties under factoring agreements. Additional disclosures regarding sales of trade receivable assets are provided in Note 15 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
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Access to Capital and Credit RatingsOur 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 StableOur corporate credit ratings at September 30, 2025 were unchanged compared with our ratings at September 30, 2024.Lower corporate debt ratings and downgrades of our corporate credit ratings or other credit ratings may increase our cost of borrowing. We believe that given our debt ratings, our financial management policies, our ability to generate cash flow and the diversified nature of our businesses, we would have access to additional short-term and long-term capital should the need arise. A rating reflects only the view of a rating agency and is not a recommendation to buy, sell or hold securities. Ratings can be revised upward or downward at any time by a rating agency if such rating agency decides that circumstances warrant such a change.
Contractual Obligations
In the normal course of business, we enter into contracts and commitments that obligate us to make payments in the future. Information regarding our obligations under purchase, debt and lease arrangements are provided in Notes 6, 16 and 18, respectively, to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Critical Accounting Estimates
The following discussion supplements the descriptions of our accounting policies contained in Note 1 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. The preparation of the consolidated financial statements requires management to use estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, as well as the disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Some of those judgments can be subjective and complex and, consequently, actual results could differ from those estimates. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. For any given estimate or assumption made by management, it is possible that other people applying reasonable judgment to the same facts and circumstances could develop different estimates. Actual results that differ from management’s estimates could have an unfavorable effect on our consolidated financial statements. Management believes the following policy areas require more significant judgment:
Revenue RecognitionOur revenues are primarily recognized when the customer obtains control of the product sold, which is generally upon shipment or delivery, depending on the delivery terms specified in the sales agreement. Revenues associated with certain instruments and equipment for which installation is complex, and therefore significantly affects the customer’s ability to use and benefit from the product, are recognized when customer acceptance of these installed products has been confirmed. For leases and for certain service arrangements, including extended warranty and software maintenance contracts, revenue is recognized ratably over the contract term. 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.
52Table of ContentsOur 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. 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 generally estimate standalone selling prices using list prices and in consideration of typical discounts offered to customers. The use of alternative estimates could result in a different amount of deferred revenue.
Our gross revenues are subject to a variety of deductions, including rebates. These deductions represent estimates of the related obligations and require judgment when determining the impact on gross revenues for a reporting period. Additional factors considered in the estimate of our rebate liability include the quantification of inventory that is either in stock at or in transit to our distributors, as well as the estimated lag time between the sale of product and the payment of corresponding rebates.Impairment of Assets
Goodwill assets are subject to impairment reviews at least annually, or whenever indicators of impairment arise. Intangible assets with finite lives, including developed technology, and other long-lived assets, are periodically reviewed for impairment when impairment indicators are present.We assess goodwill for impairment at the reporting unit level, which is defined as an operating segment or one level below an operating segment, referred to as a component. Our reporting units represent one level below reporting segments. 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.
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. We selected this method because we believe the income approach most appropriately measures the value of our income producing assets. This approach requires significant management judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, appropriate discount rates, terminal values and other assumptions and estimates. The estimates and assumptions used are consistent with BD’s business plans. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of the asset. Actual results may differ from management’s estimates.Income Taxes
BD maintains valuation allowances where it is more likely than not that all or a portion of a deferred tax asset will not be realized. Changes in valuation allowances are included in our tax provision in the period of change. In determining whether a valuation allowance is warranted, management evaluates factors such as prior earnings history, expected future earnings, carryback and carryforward periods, and tax strategies that could potentially enhance the likelihood of realization of a deferred tax asset.BD conducts business and files tax returns in numerous countries and currently has tax audits in progress in a number of tax jurisdictions. In evaluating the exposure associated with various tax filing positions, we record accruals for uncertain tax positions based on the technical support for the positions, our past audit experience with similar situations, and the potential interest and penalties related to the matters. 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.
53Table of ContentsWe 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. 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.ContingenciesWe 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. 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. 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. The accruals may change in the future as new information for an individual matter becomes available or due to changes in our litigation strategy. We record expected recoveries, up to the amount of loss recognized, from product liability insurance carriers or other parties when realization of recovery is deemed probable.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.Benefit PlansWe have significant net pension and other postretirement and postemployment benefit obligations and costs that are measured using actuarial valuations, which include assumptions for the discount rate and the expected return on plan assets. These assumptions have a significant effect on the amounts reported. In addition to the analysis below, see Note 10 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data for additional discussion.
The discount rate is selected each year based on investment grade bonds and other factors as of the measurement date (September 30). 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. 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 2026 are provided in Note 10 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. The expected long-term rate of return on plan assets assumption, although reviewed each year, changes less frequently due to the long-term nature of the assumption. This assumption does not impact the measurement of assets or liabilities as of the measurement date; rather, it is used only in the calculation of pension expense. To determine the expected long-term rate of return on pension plan assets, we consider many factors, including our historical assumptions compared with actual results; benchmark data; expected returns on various plan asset classes, as well as current and expected asset allocations. 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. We believe our discount rate and expected long-term rate of return on plan assets assumptions are appropriate based upon the above factors.
54Table of ContentsSensitivity 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. This estimate assumes no change in the shape or steepness of the company-specific yield curve used to plot the individual spot rates that will be applied to the future cash outflows for future benefit payments in order to calculate interest and service cost.• Expected return on plan assets — A change of plus (minus) 25 basis points, with other assumptions held constant, would have an estimated $4 million favorable (unfavorable) impact on U.S. pension plan costs.
Cautionary Statement Regarding Forward-Looking StatementsThis 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. Forward-looking statements may be identified by the use of words such as “plan,” “expect,” “believe,” “intend,” “will,” “may,” “anticipate,” “estimate” and other words of similar meaning in conjunction with, among other things, discussions of future operations and financial performance (including volume growth, pricing, sales and earnings per share growth, and cash flows) and statements regarding our strategy for growth, liquidity, future product development, regulatory approvals, competitive position and expenditures. All statements that address our future operating performance or events or developments that we expect or anticipate will occur in the future are forward-looking statements.Forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events, developments and operating performance, and speak only as of their dates. Investors should realize that if underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results could vary materially from our expectations and projections. Investors are therefore cautioned not to place undue reliance on any forward-looking statements. Furthermore, we undertake no obligation to update or revise any forward-looking statements after the date they are made, whether as a result of new information, future events and developments or otherwise, except as required by applicable law or regulations.
The following are some important factors that could cause our actual results to differ from our expectations in any forward-looking statements. For further discussion of certain of these factors, see Item 1A. 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
55Table of Contentscompletion, 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. Our international operations also increase our compliance risks, including risks under the Foreign Corrupt Practices Act and other anti-corruption and bribery laws, as well as regulatory and privacy laws.
• The impact of changes in U.S. federal or foreign laws and policies that could affect fiscal and tax policies, taxation (including tax reforms such as the Pillar Two framework) and international trade, including import and export licensing regulation and international trade agreements. In particular, tariffs, sanctions or other trade barriers imposed by the U.S. (and countermeasures by non-U.S. governments) could adversely impact demand for our products and services, our supply chain costs or otherwise adversely impact our results of operations and future growth. The ultimate impact of any existing or new tariffs or other changes in international trade policies is subject to a number of factors including the duration of such tariffs, changes in tariff rates, the scope and nature of the tariffs, any countermeasures that target countries may take and the availability of any mitigating actions. In addition, our tariff mitigation strategies may be challenged, rejected or eliminated through legislation or other challenges, or may otherwise not be effective.
• Cost-containment efforts in the U.S. or in other countries in which we do business, such as alternative payment reform, government-imposed pay back provisions, increased use of competitive bidding and tenders, including, without limitation, any expansion of the volume-based procurement process in China or the Center for Medicaid Services’ Competitive Bidding Program, reimbursement policy changes or the implementation of similar cost-containment efforts.
• Competitive factors that could adversely affect our operations, including new product introductions and technologies, including the use of emerging technologies (such as AI) by our current or future competitors, consolidation or strategic alliances among healthcare companies, distributors and/or payers of healthcare to improve their competitive position or develop new models for the delivery of healthcare, increased pricing pressure due to the impact of low-cost manufacturers, patents attained by competitors (particularly as patents on our products expire), new entrants into our markets, changes in the practice of medicine or the development of alternative therapies for disease states that may be delivered without a medical device.
• Product efficacy or safety concerns, changes to the labeled use of our products, non-compliance with applicable regulatory requirements regarding our products (such as non-compliance of our products with marketing authorization or registration requirements resulting from modifications to such products, or other factors, including, but not limited to, with respect to BD Alaris™ System and infusion sets and BD Vacutainer TM , resulting in product recalls, lost revenue or other actions being taken with respect to products in the field or the ability to continue selling new products to customers (including restrictions on future product clearances and civil penalties), product liability or other claims and damage to our reputation, including products we acquire through acquisitions.
• As a result of the CareFusion acquisition, our U.S. infusion pump business is operating under a Consent Decree with the FDA. The Consent Decree authorizes the FDA, in the event of any violations in the future, to order our U.S. infusion pump business to cease manufacturing and distributing products, recall products or take other actions, and order the payment of significant monetary damages if the business subject to the decree fails to comply with any provision of the Consent Decree. In accordance with our commitments to the FDA, the overall timing of replacement of the BD Alaris™ Infusion Systems and
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return to market in the U.S. may be impacted by, among other things, customer readiness, supply continuity and our continued engagement with the FDA.
• Policy and regulatory changes implemented by the U.S. federal government, including the downsizing and reduced funding of certain government agencies and programs as well as changes in the policy positions of such agencies, including the FDA, may affect the approach of agencies with which we typically engage and make regulatory approval processes and ongoing compliance with all applicable rules and regulations more challenging.
• Deficit reduction efforts, policy changes, or other actions that reduce or freeze the availability of government funding for healthcare and research, which could weaken demand for our products and result in additional pricing pressures, as well as create potential collection risks associated with such sales.
• Fluctuations and pauses in university or U.S. and international governmental funding and policies for research.
• Competitive factors that could adversely affect our operations, including new product introductions and technologies, including the use of emerging technologies (such as AI) by our current or future competitors, changes in demand as a result of changes to U.S. federal and state policies (affecting products such as pharmaceuticals and vaccines), consolidation or strategic alliances among healthcare companies, distributors and/or payers of healthcare to improve their competitive position or develop new models for the delivery of healthcare, increased pricing pressure due to the impact of low-cost manufacturers, patents attained by competitors (particularly as patents on our products expire), new entrants into our markets and changes in the practice of medicine.• Changes in the way healthcare services are delivered, including transition of more care from acute to non-acute settings and increased focus on chronic disease management, which may affect the demand for our products and services. Additionally, budget constraints and staffing shortages, particularly shortages of nursing staff, may affect the prioritization of healthcare services, which could also impact the demand for certain of our products and services.
• Our ability to achieve our projected level or mix of product sales, as our earnings forecasts are based on projected sales volumes and pricing of many product types, some of which are more profitable than others.• Changes in market dynamics, coverage policies or reimbursement practices, or adverse third-party payer cost containment measures relating to our products and services, which could reduce demand for our products or the price we can charge for such products.
• Changes in the domestic and foreign healthcare industry, in medical or clinical practices or in patient preferences that result in a reduction in procedures using our products or increased pricing pressures, including cost-reduction measures instituted by and the continued consolidation among healthcare providers.
• The effects of regulatory or other events that adversely impact our supply chain, including our ability to manufacture or sterilize our products (particularly where production of a product line or sterilization operations are concentrated in one or a few plants), source materials or components or services from suppliers (including sole-source suppliers) that are needed for such manufacturing or sterilization, or provide products to our customers, including events that impact key distributors. 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
57Table of Contentsof 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. 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
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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. In particular, the U.S. and other countries may impose new requirements regarding registration, labeling or prohibited materials that may require us to re-register products already on the market or otherwise impact our ability to market our products. 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.
The foregoing list sets forth many, but not all, of the factors that could impact our ability to achieve results described in any forward-looking statements. 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.59Table of Contents