Becton Dickinson and Company Common Stock

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 BDs 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, and economic slowdown or recession, may result in unfavorable have contributed to conditions that could negatively affecthave impacted, and may continue to impact, demand for our products and services, or the prices we can charge for our products, disrupt oaspects of our supply chain, impair our ability to produce our products, increase borrowing costs and exacerbate some of the oother risks that affect our business, financial condition and results of operations. In addition, general economic conditions may impact the healthcare industry, including

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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 20234 and we expect inflation to persist in the future but at lower levels than in fiscal year 2023. In addition, the Federal Reserve in the U.S. and other recentral banks in various countries have raised, and may again raise, interest rates in response to concerns about inflation, which, coupled with reduced government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening these risks years. Interest rate increases or other government actions taken to reduce infla addition could also result in recessionary pressures in many parts of the world. 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

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assets and liabilities, as well as our cash flows. In addition, we have previously experienced delays in collecting government receivables in certain countries due to economic conditions, and we may experience similar delays in the future in these and other countries or regions experiencing financial problems. 

We have also experienced, and may continue to experience, significant challenges in our global supply chain, including shortages in supply, or disruptions or delays inin 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, including any political. These conditions include instability resulting from war, terrorism, insurrections and civil unrest, anpolitical conflict, and changing economic conditions in these markets, 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 protection rirights 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, and changes in local healthcare payment systems and healthcare delivery systems. We also experience longer payment terms for account receivables in foreign jurisdictions than we experience in the U.S., and we face increased difficulty in establishing, staffing and managing ou, changes resulting from new political administrations, and labor foreign operations.ce 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

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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. Non-traditional entrants, such as technology companies, are also entering into the healthcare industry and some may have greater financial and other

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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.

Our ability to compete is also impacted by changing customer pand patient preferences and requirements, including increased focus on products using materials of concern and demand for more environmentally friendlysustainable products, and for products incorporating digital capabilities, aincluding artificial intelligence, as well as changes in the ways healthcare services are delivered (including , such as the transition of more care from acute to non-acute settings and increased focus on chronic disease management). T. 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. CIn 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 (such as needle-free injection technology or novel medical therapies) that 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. Managements 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.

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Market 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 marketservices, as well as access to BD products and servicesthem, depends, in part, on the healthcare funding landscape as well as nd 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. Furthermore, anIn addition, third-party payers are increasingly changes to the coverage orllenging 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 are alscontinue to usinge various mechanisms to control healthcare expenditures, including increased use of competitive bidding and tenders as well as , 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 RD, 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 protectionrights, 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, including COVID-19, which could have a material adverse effect on our business. The nature and extent of future impacts afrom any such events are highly uncertain and unpredictable.

We are subject to risks associated with public health crises, such as pandemics and epidemics, including COVID-19, whi. Such events could result in reductions in the demand for certain of oupreventative or products. While the direct imptective measures or other act of COVID-19 and many of the previons by governmentive measures moderated in FY2023, any resurgence of COVID-19,s and private health institutions that could negatively impact local or the outbreak of any other epideglobal economic or pconditions andemic, or the result in reinstatement of similar preventive measures ductions in the demand for certain the future couldof our products, negatively impact the global economy anding our business, financial condition and results of operations.

In addition, public health crises and the could resulting in significant volatility in supply and demand may impact  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. The COVID-19 pandemic changed the ways healthcare services are delivered due to budget constraints and staffing shortages, particularly shortages of nursing staff, which could impact the future demand for our products and services.

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The scope and duration of any future public health crisis, including the potential emergenace of new variants of the SARS-CoV-2 virus, the pace at 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 COVID-19 or otherany such public health crises adversely 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 forego 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 BDs 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 lead 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.

The military conflict between RussiaOperational Risks

Cybersecurity incidents and Ukraine may adversely affectbreaches or breakdowns of our business, financialinformation and technology systems or infrastructure condition and results ofuld have a material adverse effect on our operations. 

The military conflict in Ukraine has

We rely on a large number of increased global economicformation and technology (IT) systems and political uncertainty. Furthermorrelated infrastructure, governments inincluding services provided to us by the U.S., United Kingdom, and Eurird-party vendors to opean Union have each imposed export controls on certainrate our business. We collect, use, store, transfer and otherwise products and financial and economcess electronic sanctions on certaiinformation industry sectors and parties our day-to-day operations, in Russia, and additicluding personal, controls and sanctions could be enacted in the future. We continue to actively monitor the situfidential, or proprietary information in Russiaof BD and Ukraine and assess its impact on ouits customers, vendors and other business, including o partners, and patients. Some of our supplierproducts and customers. We have no manufacturing facilitiessystems collect personal, confidential or significant operproprietary informations in Russia or Ukraine regarding patients and as such, to date,patient the conflict has not had a material impact onrapy on behalf of our customers and some of our business, financial condition or results of operations. However, it is possible that the conflict in Ukraine may escalate or expand, and the scopeproducts 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, extent and duration of the military action, current or future sanclectronic medical record systems or electronic health record systems. In additions and, we resulting marketly on networks and geopolitical disruptions could be significant. We cannot predict the impact the conflict may have on the global economy or our businesservices, including internet sites, cloud and software-as-a-service (SaaS) solutions, platform-as-a-service (PaaS) solutions, financial conditiondata hosting and operations in the future. The Russia and Ukraine conflict may also heighten the impact ofprocessing facilities, artificial intelligence, tools and other risks factors described herein. These potentihardware, software (including open-source software) and technical effects couldapplications and platforms, include buing some

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that are not limited to increamanaged, hosted, provided and/or used inflation, volatility in prices for transportation, energy, commodities and oby third-party vendors, to operate our business. Further raw materials, constraints on , we expect that the availabilbreadth and complexity for usof our IT systems and our

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suppinfrastructure williers of commodities  increase as we expand other raw matur product offerials, including cobaltngs to utilize cloud technologies and energy sources, disruptionspotentially artificial in the global supply chain, decreased demand for certain of our products, disruptions to our global ttelligence, which present inherent enterprise technology infrastructurerisks, including through cyberattacks, ransom attacks or cyber-intrusose related to privacy, data protection, adv and cyberse changes in international trade policies and relations, increasecurity, that need to be managed. The foregoing could exposuree us to foreign currency fluctuations, and constrainturther risk of potential breaches, volatility or disfailures, interruptions in the credit and capital markets.

Operaand disruptional Risks

Breaches or breakdowns of our information and technologys.

While we are continuing to modernize our IT systems could have a material adverse effect on ourand infrastructure (such as hardware, software and operations.

We use a large number of information and ng systems), there are still technology systems toies in operate our business. We process, transmit,ion that are more vulnerable to risk of failures, interruptions and store electronic informadisruptions. In addition in our day-to-day operations, including sensitive personal or proprieta, while we continue to enhance business continuity and disaster recovery information. In addition, we rely on networkplans and strategies, there is no guarantee that such plans and services, including internet sites, cloud and software-as-a-service (SaaS) solutions, platform-as-a-service (PaaS) solutrategies will be effective or account for all eventualities. We have experienced, and could in the future experience, the failure, interruptions, data hosting and processing faci or disruption of the functionalities, toolsy of our IT systems and other hardwainfrastructure, software (including open-source software) and technical applications and platforms, including someor those of third-party vendors upon which we rely, which could impair our ability or that are managed, hosted, providedof our customers, suppliers and/or used by third- other business party providners, to assist in conducting our business. Some of our  business, result in the loss of BD trade secrets or otherwise comproducts includemise personal, confidential or proprietary information systems that collect data regardingof BD or its customers, suppliers and other business patients andrtners, or of patient therapy on behalfs, result in efficacy or safety concerns for certain of our customers and some connectproducts, result in reputational harm to our systems for maintenance purposesbusiness and result in actions by regulatory bodies or civil litigation.

Cyberattacks continue to increase in frequency, sophistication and intensity, and are becoming increasingly difficult to detect for periods of time, especially as they relate to attacks on third-party providers or their vevendors. Such attacks are often carried out by motivated and highly skilled actors, who are increasingly well-resourced. Our IT systems and information systemsrastructure, as well as those of various third parties on which we rely, have experienced, and are likely to continue to experience, a variety of cybersecurity attacks, including, but not limited to, unauthorized access, malicious code execution and/or phishing- attacks. Geopolitical events have also in, 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 riskmeasures on a global basis. In this increasingr remediation. For example, through our cybersecurity monitoring tools and processes, we recently hostile environment, we, or our third-party identified incidents of unauthorized activity on a portion of our IT systems, in which certain information relating to BDs IT infrastructure and service credentials for certain BD Diagnostics Solutions, BD PyxisTM, and Parata providerducts utilized by laboratories, could suffer a loss hospitals and pharmacies (the Product Service Credentials) were accessed and/or disclosuexfiltrated. After becoming aware of certain businthe incidents, BD terminated the unauthorized access informa, applied addition (or information regarding third parties al security measures, and is working with customers to update these Product Service Credentials. While an unauthorized party would have to penetrate a custoredmers local network and, in our systems) duesome cases, may also need to any numb be physically present at the instrument in order of causes ranging from catastrophic events or power outages to improperto 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 data hande of this filing or security breaches. These breaches and cyberattacks could result i, the incidents have not had, and we do not expect them to have, a material impact on BDs overall business operations, financial condition or results of operations.

In addition, certain factors, such as growth through acquisitions, rapid technology evolution, including increased adoption ourf artificial intellectual property and oigence, 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 conmpromise of personal, confidential or proprietary information be, including information regarding accessedthird parties, such as customers and patients, destroyed or stolen, which could adversely affectue to a number of causes, including, but not limited to, the exploitation of system vulnerabilities, cyberattacks, unauthorized access to our competitive positionproducts, improper data handling, breakdowns of our IT systems and in frastructure or othe market. Likewise, we r cybersecurity incidents or our third-parbreaches. These cybersecurity provincidernts and breaches could suadversely affer disrupct our reputation of our, financial condition, results of operations  or competitive position in the market and result in other significant negative consequences, including increased costs for security measures or remediation,  lost revenue, manufacturing challenges or disruption, diversion of management attention, reputlitigational damage, litiga, regulatory action and damage to our relationships with vendors, business partners and customers.

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Unauthorized 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. Cyberattacks could also, as well as impact our compliance with privacy, data protection and other laws and regulations and could result in unauthorizedreputational damage and actions by regulatory bodies or civil litigation.

In addition, access to our quisitions, and the integration of acquired companies into the Companys existing and future IT systems and prodinfrastructs, which could impact our compliance with privacy and other lawure, 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 regulthe implementations  of cybersecurity controls and could result in actions by regulatory bodies or civil lprotocols during and after the acquisition process, there can be no assurance that such measures will be sufficient to prevent, mitigation.

Ce or remediate cyberattacks are becoming more sophisticated, frequent and adaptive. security incidents or breaches, which could have a material adverse effect on our business, financial condition and results of operations.

While we have made investments tintended to address these threareats presented by cybersecurity incidents and cbreaches, continue to dedicate significant resources tintended to protect against unauthorized access of our systemour products and systems from cybersecurity incidents and productbreaches, and we continue to work with government authorities and third-party providevendors 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 future attackcybersecurity 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 energyother 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 in theto manufacture of certain products, and any significant increases in resin costs, whether due to inflationary pressure, supply constraints, regulatory changes

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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, including but not limited to, changes in general economic conditions, labor costs, transportation costs, competition and currency exchange rates. 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 bein 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, labor shortages, eextreme 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 a, labor strikes, and cost inflation.

We continuously explore

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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 more 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. IOn April 5, 20234, the EPA published proposedfinal National Emission Standards for Hazardous Air Pollutants (NESHAP): Ethylene Oxide Emissions Standards for Sterilization Facilities regulations relating to commercial sterilizers. We cannot predict what any 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 NESHAPs 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 final ized the PID, which regulations adoptedtes 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 they may have  on our sterilization facilities, on the third-party sterilization facilities that BD utilizes or onand 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

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technology, limit the use of ethylene oxide or take other actions, which would impact BDs 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 in

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place to mitigate the impact of any such disruption, although these plans may not be able to fully offset such impact, for the reasons noted above. See Item 1. 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 greenhouse gasGHG emissions (and requirements to disclose climate-related risks and metrics, including greenhouse gasGHG emissions), policies mandating or promoting the use of renewable or zero-carbon energy and sustainability initiatives, and additional taxes on fuel and energy. If lThere has been, and in the future there may be additional, legislation or regulations are eenacted or promulgated in the United States orand in any other jurisdictions in which we do business that impose more stringent restrictions and requirements ton our operations than our currenthistorical legal or regulatory obligations, as we all 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, which. 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, such a. 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 plans and targetstargets, including product-level GHG emissions data. Failure to provide climate-friendly 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 (which may involve lawsuits seekincluding pending class action status or seekims relating to establish multi-district litigation proceedings, including pending claims relating to othylene oxide, our hernia repair implant products, surgical continence and pelvic organ prolapse products for women, vena cava filter products and implantable ports), and s, 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 subpoenainvestigations 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 csecurities 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

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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.

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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 esreasonably 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 ot 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 FDAs 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 clearance or approvalauthorization from the FDA or counterpart regulatory agencies in other countries before they can be marketed or sold. Theis process for obtaining marketing approval or clearance mamay 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 AlarisTM pumps and related sets and BD VacutainerTM). 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.

We areOur CareFusion 303, Inc. subsidiary is operating under an amended c Consent dDecree with the FDA, entered into by CareFusion in 2007 and amended in 2009, thathat affects our BD Alaris infusion pump business in the U.S. We are also currently

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operating under atwo 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. In February 2023, tThe EU Parliament voted to extend tapplication of the EU MDR transition timeline, which postpones applicationhas been extended until 2027 for higher-risk Class III and implantable IIbcertain devices (excluding WET devices)considered higher-risk and to 2028 for Class IIa, Class IIb (excluding Class IIb implantable non-WET devices), and Class I sterile devices or Class Iother devices with measuring function. 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.

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We are also subject to complex and frequently changing privacy and data protection laws, rules and regulations in the U.S. as well as in allnd a significant number of other regioncountries where BD operates, regarding the collection, use, storage, security, transfer and other processing of personal informationdata. These privacy, security and data laws, rules and regulations require companies to, among other things, proteactively implement effection lawve programs and regulations enhance internal policies, business practices, processes, and controls and could impose significant limitations, require changes to our policies, practices, and processes and in some cas and additional compliance costs on us. In addition, these laws, rules imposeand restricgulations on ourrequire use or storage of personal information. These limitations and restrictions  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 informationdata 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 has become is an integral part of doing business in our sector, and the legal standards are evolving and becoming more complex worldwide. For instance, the EurA significant number of countries where we opean General Drate have enacted privacy or data Pprotection Regulation (the GDPR), applicable as of 2018 laws, rules and still one ofregulations, the strictest and most comprehensimajority of which have privacy laws in the world, is beextraterritorial scope, creating continuously enforced, and increasingly heavy fines for GDPR violations are now being levied on businesses. Finsignificant compliance challenges as we seek to maintain our global reach, with significant penalties for non-compliance with the GDPR can amount to up to 20 million or 4% of the t, based on total worldwide annual turnoverrevenue from the preceding financial year (whichever is higher) and may be imposed in conjunction with the exercise ofr. In some cases, the authoritys investigatory and corrective powers. The GDPRs extraterritorial scope makes it applicablre are restrictions on the to our U.S.-based legal entities wheneveransfer our business activities, systems and products processf personal data outside the personal data of EU residhome country. More recents. Additionally, privacy laws, rules andand data protection regulationors are also rapidly developpaying in other countries andspecial at the state level in the U.S. in parallel with federal privacy laws protecttention to emerging sensitive health information. These varying laws, rulissues linked to new digital technologies, regulations and industry standards impact BD businesses to the extent they rely on the use of personal datasuch as the use of artificial intelligence, biometrics, and create significant compliancsurveillance technologies, which pose unique challenges while maintaining our global reach. 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

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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-compliancet 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 an cybersecurity information securicident or breach, or the failure of an IT system owned or operated by us or a third party incident,with which we partner or its vendor.

Finally, changes in the tax laws and regulations of the jurisdictions including a cybersecurity breach,  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 failure of aOrganization for Economic Cooperation and Development (OECD) published Pillar Two Model Rules which impose a 15% minimum tax on informcome of large multination technology system owned oral enterprises in the jurisdictions in which they operate. Pillar Two is effective in some of the jurisdictions in which we operated by us or a beginning in fiscal year 2025. We continue to evaluate third party with e 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 partnerand our affiliates do business could change on a prospective or its vendor.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 and, 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 in

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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 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 combined 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

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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

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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.

Risks Relating to the Spin-off of Embecta Corp.

Risks relating to 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 worlds 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. Additionally, there can be no assurances that BD will be able to achieve the full strategic and financial benefits that are expected to result from the spin-off.

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 and , 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 Officers

The following is a list of the executive officers of BD, their ages and all positions and offices held by each of them during the past five years. There is no family relationship between any executive officer or director of BD.

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