Becton Dickinson & Co. (BDX) 10-K risk factor changes: FY2022 vs FY2021
The 2022-09-30 10-K against the 2021-09-30 one, compared heading by heading and sentence by sentence.
Item 1A91 rewritten89 added50 removed119 unchanged
All filing items990 rewritten633 added499 removed1,651 unchanged
Summary
counted, not written
- Item 1A lists 26 risk factor headings: 6 new, 3 reworded and 17 unchanged since FY2021. 3 headings from FY2021 no longer appear.
- Sentence by sentence, 633 added, 499 removed, 990 rewritten and 1,651 unchanged across 17 items that differ.
New Item 1A headings (6)
- Global economic conditions, including inflation and supply chain disruptions, could continue to adversely affect our operations.
- The military conflict between Russia and Ukraine may adversely affect our business, financial condition and results of operations.
- Climate change, or legal, regulatory or market measures to address climate change, could adversely affect our business, financial condition or results of operations.
- Risks Relating to the Spin-off of Embecta Corp.
- Risks relating to spin-off of Embecta Corp.
- Information About our Executive Officers
Removed Item 1A headings (3)
- A downturn in economic conditions could adversely affect our operations.
- Our business and operations are subject to risks related to climate change.
- Risks relating to proposed spin-off.
Reworded Item 1A headings (3)
- We are subject to risks associated with public health
[removed: threats,][added: crises, such as pandemics and epidemics,] including the COVID-19 pandemic, which[removed: has had, and]may continue to[removed: have,][added: have] a material adverse effect on our business. The nature and extent of future impacts are highly uncertain and unpredictable. - Breaches [added: or breakdowns] of our information [added: and technology] systems could have a material adverse effect on our operations.
- Natural disasters, war and other events [added: beyond our control] could [added: disrupt our business and] adversely affect our future revenues and operating income.
A heading is new when no FY2021 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
23 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2022; struck-through words were in FY2021. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors.
91 rewritten, 89 added, 50 removed, 119 unchanged
We are subject to risks associated with public health [removed: threats,] [added: crises, such as pandemics and epidemics,] including the COVID-19 pandemic, which [removed: has had, and] may continue to [removed: have,] [added: have] a material adverse effect on our business.
We are subject to risks associated with public health [removed: threats, including epidemics and pandemics] [added: crises,] such as [added: pandemics and epidemics, including] the COVID-19 pandemic.
[removed: As a result, we experienced] [added: This could result in] significant reductions in the demand for certain of our products due to reductions in elective and non-essential procedures, lower utilization of routine testing and related specimen collection, reduced capital spend by [removed: customers and a decrease] [added: customers, decreases] in research activity due to laboratory closures and reduced clinical [removed: testing.][added: testing, as well as hospital and clinical occupancy and healthcare system staffing shortages.]
These measures could [added: also] include determinations that our or our suppliers’ facilities are not essential [removed: businesses that] [added: businesses, which] could result in closures or other restrictions that significantly disrupt our operations or those of distributors or suppliers in our supply chain.
While COVID-19 case volumes have decreased in the U.S and certain other countries, the global outlook remains uncertain as case counts fluctuate and vaccination [added: and booster] rates remain relatively low in many parts of the world.
Going forward, medical procedure rates may vary by country based on regional [removed: COVID-19] infection and vaccination [added: and booster] rates, hospital occupancy and staffing levels, transportation limitations, quarantines and other restrictions, and the emergence of new [removed: COVID-19 variants.][added: variants of the SARS-CoV-2 virus.]
In addition, the COVID-19 pandemic has impacted our global supply chain network, and we may [added: continue to] experience [added: significant challenges in our network, including shortages in supply or] disruptions or delays in [removed: shipments] [added: shipments, as well as price increases,] of certain materials or components used in our products.
We have experienced, and may continue to experience, significant challenges to our global transportation channels and other aspects of [removed: the] [added: our] global supply chain network, including to the cost and availability of raw materials and components due to shortages and [removed: resulting] cost inflation.
[removed: Any such delays or shortages may result in our inability to meet customer demand for our products and as] [added: As] COVID-19 conditions [removed: improve,] [added: have improved,] there [removed: may be unpredictable] [added: have been] increases in demand for certain of our products, which may pose challenges to our supply chain and could adversely affect our business.
In addition, in response to the [removed: pandemic,] [added: pandemic] we developed and launched multiple products for the detection and identification of COVID-19, including tests for our BD Max™ molecular System and BD Veritor™ Plus System, and there are a number of factors, including [removed: the rate of] vaccination and [added: booster rates and] the availability of competitive products, that [added: have impacted in the past, and] could impact [added: in] the [added: future, the] level of demand and pricing for our COVID-19 diagnostics testing.
The scope and duration of [removed: the pandemic, including] [added: any] future [removed: resurgences globally,] [added: public health crisis, including] the [added: potential emergence of new variants of the SARS-CoV-2 virus, the] pace at which government restrictions are [removed: lifted or whether] [added: imposed and lifted, the scope of] additional actions [removed: may be] taken to [removed: contain the virus,] [added: mitigate] the [added: spread of disease,] global vaccination [removed: rate,] [added: and booster rates,] the speed and extent to which global markets and utilization rates for our products fully recover from the disruptions caused by [removed: the pandemic,] [added: such a public health crisis,] and the impact of these factors on our business, financial condition and results of [removed: operations, will depend on future developments that are highly uncertain and cannot be predicted with confidence.]
To the extent [added: the] COVID-19 [added: pandemic or other public health crises] adversely [removed: affects] [added: affect] our operations and global economic conditions more generally, it may also have the effect of heightening many of the other risks described herein.
[removed: A downturn in] [added: Global] economic [removed: conditions] [added: conditions, including inflation and supply chain disruptions,] could [added: continue to] adversely affect our operations.
Deterioration in the domestic or international economic environment, particularly in emerging markets and countries with government-sponsored healthcare systems, may cause decreased demand for our products and services and increased competition, which could result in lower sales volume and lower prices for our products, longer sales cycles, and slower adoption of new [removed: technologies.][added: technologies, as well as increase the cost of operating our business or contribute to disruptions in our supply chain.]
[removed: We] [added: In addition, we] have previously experienced delays in collecting government receivables in certain countries [removed: in Western Europe] due to economic conditions, and we may experience similar delays in the future in these and other countries or regions experiencing financial problems.
We are a global company that faces significant competition from a wide range of [removed: companies.][added: existing competitors and new market entrants.]
These include large medical device companies with multiple product lines, some of which may have greater financial and marketing resources than we do, as well as firms [removed: that] [added: 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 [removed: industry,] [added: industry and] some [removed: of which] may have greater financial and marketing resources than we do.
Our ability to compete is also impacted by changing customer preferences and requirements, such as increased demand for more [removed: environmentally-friendly] [added: environmentally friendly] products and for products incorporating digital capabilities, as well as changes in the ways [removed: health care] [added: healthcare] services are delivered (including the transition of more care from acute to non-acute settings and increased focus on chronic disease management).
Our ability to remain competitive will depend on how well we meet these [removed: changing market demands in terms of our product offerings and marketing approaches.]
The medical technology industry is also subject to rapid technological [removed: change and] [added: 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) that provide better features, pricing, clinical outcomes or [added: economic value may render our products or proposed products obsolete or less competitive.]
In some instances, competitors, including pharmaceutical companies, also [removed: offer, or] [added: offer (or] are attempting to [removed: develop,] [added: develop)] alternative therapies for disease states that may be delivered without a medical device.
In addition, [removed: health care] [added: healthcare] systems and other providers are consolidating, resulting in greater purchasing power for these companies.
A substantial amount of our [removed: revenues are] [added: revenue is] derived from international operations, and we anticipate that a significant portion of our [added: future] sales will continue to come from outside the U.S. [removed: in] [added: The revenues we report with respect to our operations outside] the [removed: future.][added: U.S. may 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.]
Management’s Discussion [added: and Analysis] of Financial Condition and Results of Operations.
Any [added: 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 [added: effectively] mitigate these risks.
Reforms to reimbursement systems in the [removed: United States] [added: U.S.] or abroad, changes in coverage or reimbursement rates by private payers, 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 [removed: would] [added: could] adversely affect customer demand or the price customers are willing to pay for such products.
Initiatives to limit the growth of healthcare costs in the U.S. and other countries where we do business may also put [added: industry-wide] pressure on medical device [added: or clinical diagnostic] pricing.
Governments in China and other countries are also using various mechanisms to control healthcare expenditures, including increased use of competitive bidding and [removed: tenders, and] [added: tenders as well as] price regulation.
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 [removed: United States] [added: U.S.] and [added: abroad, manufacture products in a cost-effective manner, obtain appropriate intellectual property protections, and gain and maintain market acceptance of our products.]
There can be no assurance that any products now in [removed: development] [added: development,] or that we may seek to develop in the [removed: future] [added: future,] will achieve technological feasibility, obtain regulatory approval or gain market acceptance.
A substantial amount of our sales come from our operations outside the [removed: United States,] [added: U.S.,] and we intend to continue to pursue growth opportunities in foreign markets, especially in emerging markets.
The success of our operations outside the [removed: United States] [added: 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.
[removed: In addition, our international operations are governed by the U.S. Foreign Corrupt Practices Act and similar anti-corruption laws outside the U.S.] 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 [added: relating] to [removed: enhance] 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.
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 (“NIH”) and [added: similar] agencies in other countries.
For instance, [removed: there have been instances where] [added: certain] NIH grants have been frozen or otherwise unavailable for extended periods.
The availability of governmental research funding may be adversely affected by economic conditions and governmental spending [removed: reductions.][added: reductions, particularly during periods of economic uncertainty.]
While many countries around the world have removed or reduced the restrictions taken in response to the COVID-19 pandemic, the emergence of new variants of the SARS-CoV-2 virus may result in new governmental lockdowns, quarantine requirements or other restrictions to slow the spread of the virus.
In addition, any such measures could also impact the global
economy more broadly, for example by leading to further economic slowdowns.
The COVID-19 pandemic has escalated challenges that existed for global healthcare systems prior to the pandemic, including budget constraints and staffing shortages, particularly shortages of nursing staff, that could impact the future demand for our products and services.
operations, will depend on future developments that are highly uncertain and cannot be predicted with confidence.
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 conditions that could negatively affect demand for our products and exacerbate some of the other risks that affect our business, financial condition and results of operations.
Both domestic and international markets experienced significant inflationary pressures in fiscal year 2022 and inflation rates in the U.S., as well as in other countries in which we operate, are currently expected to continue at elevated levels for the near-term.
In addition, the Federal Reserve in the U.S. and other central 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.
Interest rate increases or other government actions taken to reduce inflation 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 assets and liabilities, as well as our cash flows.
We have also experienced significant challenges in our global supply chain, including shortages in supply, or disruptions or delays in 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.
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.
Changes in regulatory or market standards, including without limitation cybersecurity requirements, often require significant investment to maintain compliance to relevant standards.
changing market, regulatory and cybersecurity demands in terms of our product offerings and marketing approaches.
Fluctuations in exchange rates between the U.S. dollar and other currencies may also affect the reported value of BD’s assets and liabilities, as well as our cash flows.
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.
Additionally, the ongoing global semiconductor chip and component shortage could impact certain critical components of our R&D process, which could adversely affect our business, financial condition and results of operations.
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 general political conditions, including any political instability (such as those resulting from war, terrorism and insurrections) and general 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 the governments of the foreign countries in which we operate, changes to international trade agreements and treaties, increases in trade protectionism, or the weakening or loss of certain intellectual property protection 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, 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 our foreign operations.
In addition, our international operations are governed by the U.S. Foreign Corrupt Practices Act and similar foreign anti-corruption laws.
There has been an overall tightening and increasingly competitive labor market.
A sustained labor shortage or increased turnover rates within our employee base could 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.
The military conflict between Russia and Ukraine may adversely affect our business, financial condition and results of operations.
The military conflict in Ukraine has increased global economic and political uncertainty.
Furthermore, governments in the U.S., United Kingdom, and European Union have each imposed export controls on certain products and financial and economic sanctions on certain industry sectors and parties in Russia, and additional controls and sanctions could be enacted in the future.
We are continuing to actively monitor the situation in Russia and Ukraine and assess its impact on our business, including our suppliers and customers.
We have no manufacturing facilities or significant operations in Russia or Ukraine and as such, to date, the conflict has not had a material impact on our business, financial condition or results of operations.
However, it is possible that the conflict in Ukraine may escalate or expand, and the scope, extent and duration of the military action, current or future sanctions and resulting market and geopolitical disruptions could be significant.
We cannot predict the impact the conflict may have on the global economy or our business, financial condition and operations in the future.
The Russia and Ukraine conflict may also heighten the impact of other risks factors described herein.
These potential effects could include but are not limited to increased inflation; volatility in prices for transportation, energy, commodities and other raw materials; constraints on the availability for us and our suppliers of commodities and other raw materials, including cobalt and energy sources; disruptions in the global supply chain; decreased demand for certain of our products; disruptions to our global technology infrastructure, including through cyberattacks, ransom attacks or cyber-intrusion; adverse changes in international trade policies and relations; increased exposure to foreign currency fluctuations; and constraints, volatility or disruptions in the credit and capital markets.
We are increasingly reliant upon a number of information and technology systems to operate our business.
sensitive personal or proprietary information.
In addition, we rely on networks and services, including internet sites, cloud and software-as-a-service (“SaaS”) solutions, data hosting and processing facilities, 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 providers, to assist in conducting our business.
Cyberattacks continue to increase in their 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 vendors.
The outbreak of COVID-19 in 2020 and the travel restrictions, quarantines and other actions taken by governments and the private sector to slow the spread of the virus resulted in a global economic slowdown, and caused healthcare systems to divert resources to manage the pandemic.
These measures led to unprecedented restrictions on and disruptions in businesses and personal activities.
Any resurgences in COVID-19 infections or new strains of the virus could result in the imposition of new governmental lockdowns, quarantine requirements or other restrictions to slow the spread of the virus, or the deferral of elective medical procedures, which could weaken demand for certain of our products.
While utilization rates for most of our products have largely recovered to pre-pandemic levels, future deferrals of elective medical procedures and/or the imposition of new governmental restrictions due to resurgences in COVID-19 infections or new strains of the virus may weaken demand for certain of our products and/or disrupt our operations.
Additionally, on September 9, 2021, President Biden issued an executive order requiring all employers with U.S. Government contracts to require that their U.S.-based employees, contractors, and certain subcontractors, that work on or in support of U.S. Government contracts, are fully vaccinated as set forth in the executive order, except for any employees with a medical or religious exemption.
As a U.S. Government contractor, we are required to comply with the executive order.
The implementation of these requirements may result in employee attrition, which could be material as a substantial number of our manufacturing and distribution center employees are based in areas of the country where vaccination rates are below the national average.
If we were to lose employees, it may be difficult or very costly in the current competitive labor market
to find and recruit replacement employees, and this could have a material adverse effect on our business, results of operations and financial condition.
Furthermore, on September 9, 2021, President Biden announced that he has directed The Department of Labor's Occupational Safety and Health Administration (“OSHA”) to develop an Emergency Temporary Standard (“ETS”) mandating either the full vaccination or weekly testing of employees for employers with 100 or more employees.
On November 4, 2021, OSHA issued the ETS, which requires employers with 100 or more employees to develop, implement and enforce a mandatory COVID-19 vaccination policy, unless they adopt a policy requiring employees to choose to either be vaccinated or undergo regular COVID-19 testing and wear a face covering at work.
The ETS and the executive order are effective as of January 4, 2022.
On November 12, 2021, the U.S. Court of Appeals for the Fifth Circuit granted a motion to stay OSHA’s ETS and ordered that OSHA take no further steps to implement or enforce the ETS until a further court order.
Due to the pending litigation, OSHA has suspended activities related to the implementation and enforcement of the ETS pending future developments.
It is currently not possible to predict with certainty the impact the executive order or OSHA’s ETS will have on our workforce.
Additional vaccine mandates may also be implemented in other jurisdictions in which we operate.
A weakening of macroeconomic conditions may also adversely affect our suppliers, which could result in interruptions in supply.
economic value may render our products or proposed products obsolete or less competitive.
The revenues we report with respect to our operations outside the United States may be adversely affected by fluctuations in foreign currency exchange rates.
abroad, manufacture products in a cost-effective manner, obtain appropriate intellectual property protection, and gain and maintain market acceptance of our products.
Our foreign operations subject us to certain risks relating to, among other things, fluctuations in foreign currency exchange (discussed above), local political conditions, general economic conditions such as inflation, deflation, interest rate volatility and credit availability, competition from local companies, increases in trade protectionism, U.S. relations with the governments of the foreign countries in which we operate, foreign regulatory requirements or changes in such requirements, changes in local health care payment systems and health care delivery systems, local product preferences and requirements, longer payment terms for account receivables than we experience in the U.S., difficulty in establishing, staffing and managing foreign operations, changes to international trade agreements and treaties, changes in tax laws, weakening or loss of the protection of intellectual property rights in some countries, and import or export licensing requirements.
Changes in U.S. policy regarding international trade, including import and export regulation and international trade agreements, could also negatively impact our business.
The U.S. has imposed tariffs on steel and aluminum as well as on goods imported from China and certain other countries, which has resulted in retaliatory tariffs by China and other countries.
Additional tariffs imposed by the U.S. on a broader range of imports, or further retaliatory trade measures taken by China or other countries in response, could result in an increase in supply chain costs that we may not be able to offset or that otherwise adversely impact our results of operations.
From time to time there may be shortages of skilled labor, which may make it more difficult for us to attract and retain qualified employees or lead to increased labor costs.
For a further discussion of risks related to the Biden administration vaccine mandates, see the above-referenced Risk Factor, “We are subject to risks associated with public health threats, including the COVID-19 pandemic, which has had, and may continue to have, a material adverse effect on our business.
The nature and extent of future impacts are highly uncertain and unpredictable.”
In addition to our own information, in the course of doing business, we sometimes store information with third parties that could be subject to attacks.
Certain raw materials and components are not available from multiple sources.
At a broader level, several states have increased the regulatory requirements associated with the use and emission of ethylene oxide for sterilization.
Our business and operations are subject to risks related to climate change.
The long-term effects of global climate change present risks to our business.
hospitals, medical care facilities and other customers.
In addition, regulations intended to limit greenhouse gas emissions, such as taxes on fuel and energy, to mitigate the impacts of climate change may increase, which could increase our operating costs and the costs charged by suppliers.
These events could adversely affect our operations and our financial performance.
The enactment of
We are also currently operating under a warning letter issued by the FDA.
Manufacturers of in vitro diagnostic medical devices have until May 2022 to meet the EU IVDR.
and increasingly heavy fines are now being levied on businesses.
Privacy laws, rules and regulations are also rapidly developing in other regions.
An excerpt. Shown here: 40 of 91 rewritten, 40 of 89 added and 40 of 50 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors. in the FY2022 filing and the FY2021 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
203 rewritten, 154 added, 145 removed, 306 unchanged
BD remains focused on delivering durable [removed: growth and] [added: growth,] creating shareholder [removed: value, while] [added: value and] making appropriate investments for the future.
- Driving operating effectiveness and margin expansion by [removed: placing controls on sourcing and transportation costs, as well as by] increasing [removed: labor] [added: factory] productivity and asset efficiencies;
- Focusing on cash management in order to improve balance sheet [removed: productivity;][added: productivity.]
- Working across our supply chain to [added: responsibly source materials and goods, as well as to] reduce environmental impacts;
- Creating more resilient operations [removed: based on] [added: through investments in] an enterprise-wide renewable energy strategy;
- Cultivating an inclusive work environment that welcomes and celebrates diverse talent and [removed: perspectives.][added: perspectives;]
BD’s [removed: Intention to Spin Off] [added: Spin-Off of] Diabetes Care
[removed: Our 2021] [added: As such, our fiscal year 2022] revenues [added: in our Life Sciences segment] reflected [removed: a substantial benefit from] sales related to [removed: COVID-19] [added: COVID-19-only] diagnostic testing on the BD VeritorTM [removed: Plus] [added: Plus, BD VeritorTM At-Home] and BD MaxTM [removed: Systems.][added: Systems of $511 million, compared with revenues from such testing products in 2021 of $1.956 billion.]
Due to the significant uncertainty that exists relative to the duration and overall impact of the [removed: COVID-19 pandemic,] [added: macroeconomic factors discussed above,] our future operating performance, particularly in the short-term, may be subject to volatility.
[removed: While non-acute utilization] [added: Utilization] rates for most of our products have [removed: largely] recovered [added: compared] to pre-pandemic [removed: levels,] [added: levels; however, future] resurgences in COVID-19 infections or new strains of the virus may [added: affect the prioritization of non-acute versus acute healthcare utilization, which may temporarily] weaken future demand for certain of our products [removed: and/or disrupt] [added: and increase the demand for other of] our [removed: operations.][added: products.]
The impacts of [removed: the COVID-19 pandemic] [added: macroeconomic conditions] on our business, results of operations, financial condition and cash flows [removed: is] [added: are] dependent on certain [removed: factors including:][added: factors, including those discussed in Item 1A.]
[removed: - The degree to which] [added: Additionally,] the pandemic has escalated challenges that existed for global healthcare systems prior to the pandemic, [removed: such as] [added: including budget constraints and] staffing shortages, [removed: including] [added: particularly shortages of] nursing [removed: shortages, and budget constraints;][added: staff.]
[removed: -] The Life Sciences [removed: segment’s] [added: segment's] revenues in 2021 [added: primarily] reflected [removed: growth] [added: a favorable comparison to 2020, which was significantly impacted by pandemic-related declines] in both units.
[removed: Growth] [added: Revenue growth] in the Integrated Diagnostic Solutions unit [removed: included approximately $2 billion of revenues] [added: was also] driven by [removed: COVID-19] [added: sales related to COVID-19-only] diagnostic testing [removed: primarily] on the BD VeritorTM Plus and BD MaxTM Systems.
We continue to invest in research and development, [added: strategic tuck-in acquisitions,] geographic expansion, and new product programs to drive further revenue and profit growth.
As [added: further] discussed above, current global economic conditions [removed: remain] [added: have been] relatively volatile due to [removed: the COVID-19 pandemic.][added: various macroeconomic factors.]
Our financial position remains strong, with cash flows from [added: continuing] operating activities totaling [removed: $4.647] [added: $2.471] billion in [removed: 2021.][added: 2022.]
At September 30, [removed: 2021,] [added: 2022,] we had [removed: $2.403] [added: $1.167] billion in cash and equivalents and short-term investments, including restricted cash.
During fiscal year [removed: 2021,] [added: 2022,] we paid cash dividends of [removed: $1.048] [added: $1.082] billion, including [removed: $958] [added: $992] million paid to common shareholders and $90 million paid to preferred shareholders.
We also repurchased approximately [removed: $1.750 billion] [added: $500 million] of our common stock during fiscal year [removed: 2021.][added: 2022.]
A [removed: weaker] [added: stronger] U.S. dollar, compared to the prior-year period, resulted in [removed: a favorable] [added: an unfavorable] foreign currency translation impact to our revenues [removed: and an unfavorable impact to our expenses] during [removed: 2021.][added: 2022.]
| | | | | | | | | | | | | | | | | | | | | | [removed: 2021] [added: 2022] vs. [removed: 2020] [added: 2021] | | | | | | | | | | | | | | | | | | [removed: 2020] [added: 2021] vs. [removed: 2019] [added: 2020] | | | | | | | | | | | | | | |
| (Millions of dollars) | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | Total Change | | | | | | Estimated FX Impact | | | | | | FXN Change | | | | | | Total Change | | | | | | Estimated FX Impact | | | | | | FXN Change | | |
| Medication Management Solutions | | | [removed: 2,432] [added: 2,533] | | | | | | [removed: 2,454] [added: 2,432] | | | | | | [removed: 2,640] [added: 2,454] | | | | | | [removed: (0.9)] [added: 4.1] | | % | | | | [removed: 1.4] [added: (1.5)] | | % | | | | [removed: (2.3)] [added: 5.6] | | % | | | | [removed: (7.1)] [added: (0.9)] | | % | | | | [removed: (0.5)] [added: 1.4] | | % | | | | [removed: (6.6)] [added: (2.3)] | | % |
These prior-year pandemic-related declines impacted our Medication Delivery Solutions [removed: unit, and to a lesser extent, the][added: unit.]
[added: In the Medication Management] Solutions unit, lower revenues in 2021 reflected an unfavorable comparison to 2020, which benefited from global pandemic-related infusion pump orders.
The Pharmaceutical Systems unit’s revenue growth in 2021 [removed: reflected continued strong growth that is being] [added: was enabled by capacity expansion efforts and was] driven by [added: continued strong] demand for our pre-filled [removed: devices] [added: devices, which reflected the vial to pre-filled device conversion for biologics, vaccines,] and [removed: is enabled by capacity expansion efforts.][added: other injectable drugs.]
We will not be able to fully resume commercial operations for the BD Alaris [removed: System™] [added: System] in the [removed: United States] [added: U.S.] until [removed: a] [added: BD’s] 510(k) submission relating to the product has been cleared by the FDA.
| (Millions of dollars) | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |
| Medical segment operating income | | | $ | [removed: 2,583] [added: 2,215] | | | | | $ | [removed: 2,274] [added: 1,985] | | | | | $ | [removed: 2,824] [added: 1,675] | |
| *Segment operating income as % of Medical revenues* | | | [removed: *27.3*] [added: *25.1*] | | *%* | | | | [removed: *26.2*] [added: *23.7*] | | *%* | | | | [removed: *31.2*] [added: *21.9*] | | *%* |
[removed: As discussed in greater detail below, the Medical] [added: The Interventional] segment's operating income in [added: 2022 and] 2021 was [added: primarily] driven by [removed: higher] [added: improved] gross profit margin.
Operating income in [removed: 2020] [added: 2021] was [added: primarily] driven by [removed: a decline in] [added: improved] gross profit margin.
◦A favorable comparison to 2020, which was unfavorably impacted by increased levels of manufacturing overhead costs that were recognized in the period because of the COVID-19 pandemic, rather than capitalized within inventory, and $244 million of net charges recorded in 2020, compared with charges of $56 million in 2021, for [removed: estimated future costs within the Medication Management Solutions unit associated with] remediation efforts related to AlarisTM infusion [removed: pumps;][added: pumps, as also discussed above;]
- The Medical [removed: segment's lower] [added: segment’s higher] gross profit margin in [removed: 2020] [added: 2022] compared with [removed: 2019] [added: 2021] primarily reflected the following:
[removed: ◦The favorable impact of lower] [added: ◦Lower] manufacturing costs resulting from continuous improvement projects which enhanced the efficiency of our [removed: operations.][added: operations, as well as favorable impacts from price and foreign currency translation; partially offset by]
[removed: -] Selling and administrative expense as a percentage of revenues in 2021 was flat compared with [removed: 2020,] [added: 2020] primarily due to the increase in revenues in 2021, [removed: partially] offset by higher travel and other administrative costs compared with 2020, which benefited from cost containment measures enacted in response to the COVID-19 pandemic.
Selling and administrative expense as a percentage of revenues in [removed: 2020] [added: 2021] was [removed: slightly] lower compared with [removed: 2019] [added: 2020] primarily due [removed: to lower expenses resulting from cost containment measures.][added: the recovery of segment revenues.]
[removed: -] Research and development expense as a percentage of revenues was higher in 2021 compared with [removed: 2020] [added: 2020,] which [removed: primarily reflects] [added: reflected] our commitment to research and development through continued reinvestment into our growth initiatives.
Research and development expense as a percentage of revenues was higher in [removed: 2020] [added: 2021] compared with [removed: 2019] [added: 2020] which [added: primarily] reflected [removed: the decline in revenues in 2020, as well as] [added: reinvestment into] our [removed: continued commitment to drive innovation with new products and platforms.][added: growth initiatives.]
- Accelerating innovation in smart connected care, enabling new care settings and improving chronic disease outcomes;
- Reducing complexity and improving customer experience by rationalizing our product portfolio and through the simplification and optimization of our operating model;
- Making strategic investments to advance quality culture and our core quality management system to serve our patients and ensure we are a best-in-class, proactive quality-driven organization;
- Driving sustainability initiatives within our organizational units to support enterprise-wide collaboration towards our sustainability strategy;
- Growing and enabling talent through training, development and reskilling strategies.
On April 1, 2022, BD completed the separation and distribution of Embecta, formerly BD's Diabetes Care business, into a separate, publicly-traded company.
The historical results of the Diabetes Care business (previously included in BD’s Medical segment), as well as interest expense related to indebtedness incurred by Embecta prior to the spin-off date, have been reflected as discontinued operations in our consolidated financial statements for all periods prior to the spin-off date of April 1, 2022.
Key Trends Affecting Results of Operations
As noted above, our products are manufactured and sold worldwide, which exposes our operations, supply chain and suppliers to various global macroeconomic factors.
The factors which were most impactful to our fiscal year 2022 results and that continue to be impactful to our operating results include the following:
- Inflation, which has increased the costs of raw materials, components, labor, energy, and logistical services;
- Availability of skilled labor (especially in North America), global energy sources, raw materials and electronic components; and
- Constrained logistics capacity related to the movement of goods around the globe.
During fiscal year 2022, the shortages of certain raw materials and components, delays in global transportation and labor shortages in our manufacturing facilities increased lead times for some of our product
offerings.
Also, significant inflationary pressures impacted our supply chain costs in certain areas throughout 2022.
We experienced higher costs for raw materials, particularly resins, as well as for electronic components and freight.
These increased costs put pressure on our operating expenses and the costs of our investments.
We have been mitigating these inflationary pressures through the following:
- Driving strategic procurement initiatives to leverage alternative sources of raw material and transportation;
- Implementing cost-containment measures, as well as intensifying continuous improvement and restructuring programs in our manufacturing and distribution facilities;
- Continuing strategic product line rationalization programs as part of our simplification strategy; and
- Optimizing our sales through product allocation and customer management.
The COVID-19 pandemic continued to drive volatile global economic conditions during our fiscal year 2022.
The pandemic has contributed to the inflationary pressures and supply chain disruptions discussed above and these challenges could persist if governments impose lockdowns, quarantine requirements and other restrictions in order to control rates of COVID-19 infections, such as in China.
Changes in the ways healthcare services are delivered, including the transition of more care from acute to non-acute settings and increased focus on chronic disease management, may place 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, staffing shortages within healthcare systems may affect the prioritization of healthcare services, which could also impact the demand for certain of our products.
Geopolitical conditions may also impact our operations.
Our operations in Russia and Ukraine are not material to our financial results, and as such, the conflict between Russia and Ukraine did not materially impact our results of operations in 2022.
However, the continuation of the Russia-Ukraine military conflict and/or an escalation of the conflict beyond its current scope may further weaken the global economy and could result in additional inflationary pressures and supply chain constraints, including the unavailability and cost of energy.
Risk Factors.
Worldwide revenues in 2022 of $18.870 billion decreased 1.4% from the prior-year period.
This decrease reflected the following impacts:
| | | | Increase (decrease) in current-period revenues | | | | | | | | |
| Volume | | | 6.2 | | % | | | | | | |
| Period-over-period decline in revenues related to COVID-19-only testing | | | (7.5) | | % | | | | | | |
| Pricing | | | 2.2 | | % | | | | | | |
| | | | | | | | | | | | |
| Decrease in revenues from the prior-year period | | | (1.4) | | % | | | | | | |
- Reducing complexity across our manufacturing network and rationalizing our product portfolio to optimize architecture, portfolio and business processes;
- Enhancing our quality and risk management systems;
- Simplifying our internal business processes.
On May 6, 2021, we announced our intention to spin off our Diabetes Care business as a separate publicly traded company to BD’s shareholders.
The proposed spin-off is intended to be a tax-free transaction for U.S. federal income tax purposes and is expected to be completed in the first half of calendar year 2022, subject to the satisfaction of customary conditions, including final approval from BD’s Board of Directors and the effectiveness of a registration statement on Form 10.
The Company believes that as an independent, publicly traded entity, the Diabetes Care business will be positioned to more effectively allocate its capital and operational resources with a dedicated growth strategy.
For further discussion of risks relating to the proposed spin-off of our Diabetes Care business, see Item 1A.
Risk Factors—Risks Relating to the Proposed Spin-off of the Diabetes Care Business.
COVID-19 Pandemic Impacts and Response
A novel strain of coronavirus disease (“COVID-19”) was officially declared a pandemic by the World Health Organization in March 2020 and governments around the world have been implementing various measures to slow and control the ongoing spread of COVID-19.
These government measures, as well as a shift in healthcare priorities, resulted in a significant decline in medical procedures in our fiscal year 2020.
Demand for our products showed substantial recovery in our fiscal year 2021; however, regional resurgences in COVID-19 infections and the emergence of the Delta variant continued to impact the demand for certain of our products in our fiscal year 2021.
The factors that affected our revenue growth in fiscal year 2021, including those related to the COVID-19 pandemic, are discussed in greater detail further below.
We also continue to see challenges posed by the pandemic to global transportation channels and other aspects of our supply chain, including the cost and availability of raw materials, as well as logistical challenges affecting the movement of freight around the globe.
The United States and other governments may enact or use laws and regulations, such as the Defense Production Act or export restrictions, to ensure availability of needed COVID-19 testing and vaccination delivery devices.
Any such action may impact our global supply chain network.
- The extent to which resurgences in COVID-19 infections or new strains of the virus, including the Delta variant, result in future deferrals of elective medical procedures and/or the extent to which the imposition of new governmental lockdowns, quarantine requirements or other restrictions may weaken demand for certain of our products and/or disrupt our operations;
- The degree to which demand and pricing for our COVID-19 diagnostics testing solutions continues to be impacted by reduced infection rates, as well as by distribution and utilization of available COVID-19 vaccines and the availability of competitive SARS-CoV-2 diagnostic testing products, which we expect will result in lower COVID-19 testing revenues in future periods;
- The continued momentum of the global economy’s recovery from the pandemic and the degree of pressure that a weakened macroeconomic environment would put on future healthcare utilization and the global demand for our products.
We remain focused on partnering with governments, healthcare systems, and healthcare professionals to navigate the COVID-19 pandemic.
This focus includes providing access to our SARS-CoV-2 diagnostics tests and injection devices for global vaccination campaigns, as well as supplying products and solutions for ongoing care for patients around the world.
We have also remained focused on protecting the health and safety of BD employees while ensuring continued availability of BD’s critical medical devices and technologies during these unprecedented times.
Worldwide revenues in 2021 of $20.248 billion increased 18.3% from the prior-year period, which primarily reflected an increase in volume, including increases attributable to our core products, of approximately 15.3%.
Revenues in 2021 also reflected a favorable impact from foreign currency translation of approximately 2.7%, as well as a favorable impact from price of approximately 0.3%.
Volume in 2021 reflected increased demand for our broad portfolio of products and was driven by the following:
- The Medical segment’s revenues in 2021 reflected increased demand in the Medication Delivery Solutions, Pharmaceutical Systems and Diabetes Care units, which was partially offset by a decline in the Medication Management Solutions unit.
- Interventional segment revenues in 2021 reflected increased demand in all three units as hospital utilization increased and new product offerings drove higher sales.
We have reinvested over $200 million of the profits from our sales related to COVID-19 diagnostic testing into our BD 2025 strategy.
In addition, an inability to increase or maintain selling prices globally could adversely impact our businesses.
Also, we are experiencing challenges related to global transportation channels and supply chains.
These challenges have subjected certain of our costs, specifically raw material and freight costs, to inflationary pressures which have unfavorably impacted our gross profit and operating margins.
Additional
discussion regarding the impacts of these inflationary pressures on our operating results in 2021 is provided further below.
| Medication Delivery Solutions | | | $ | 4,057 | | | | | $ | 3,555 | | | | | $ | 3,848 | | | | | 14.1 | | % | | | | 2.4 | | % | | | | 11.7 | | % | | | | (7.6) | | % | | | | (1.4) | | % | | | | (6.2) | | % |
| Diabetes Care | | | 1,160 | | | | | | 1,084 | | | | | | 1,110 | | | | | | 7.0 | | % | | | | 2.2 | | % | | | | 4.8 | | % | | | | (2.4) | | % | | | | (1.4) | | % | | | | (1.0) | | % |
| Pharmaceutical Systems | | | 1,829 | | | | | | 1,588 | | | | | | 1,465 | | | | | | 15.2 | | % | | | | 4.1 | | % | | | | 11.1 | | % | | | | 8.4 | | % | | | | (1.0) | | % | | | | 9.4 | | % |
| Total Medical revenues | | | $ | 9,479 | | | | | $ | 8,680 | | | | | $ | 9,064 | | | | | 9.2 | | % | | | | 2.4 | | % | | | | 6.8 | | % | | | | (4.2) | | % | | | | (1.0) | | % | | | | (3.2) | | % |
Diabetes Care unit.
In the Medication Management
Growth in the Diabetes Care unit benefited from the timing of sales, slightly better than expected market demand and a favorable comparison to 2020, which was impacted by pandemic-related declines.
An excerpt. Shown here: 40 of 203 rewritten, 40 of 154 added and 40 of 145 removed. The counts are complete. For every sentence, read Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in the FY2022 filing and the FY2021 filing.
Item 1. Business.
66 rewritten, 38 added, 29 removed, 169 unchanged
We provide customer solutions that are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology care; enhancing the diagnosis of infectious diseases and cancers; [added: and] advancing cellular research and [removed: applications; and supporting the management of diabetes.][added: applications.]
Information with respect to BD’s business segments is included in Note [removed: 7] [added: 8] to the consolidated financial statements contained in Item 8.
| Medication Management Solutions | | | IV medication safety and infusion therapy delivery systems, including infusion pumps, dedicated disposables, and IV fluids; medication compounding workflow systems; automated medication dispensing; automated supply management systems; medication inventory optimization and tracking systems; [removed: and] informatics and analytics solutions for enterprise medication [removed: management.] [added: management; and pharmacy automation systems.] | | |
| Integrated Diagnostic Solutions | | | Integrated systems for specimen collection; safety-engineered blood collection products and systems; automated blood culturing and tuberculosis culturing systems; molecular testing systems for infectious diseases and women’s health; microorganism identification and drug susceptibility systems; liquid-based cytology systems and HPV tests for cervical cancer [removed: screening;] [added: screening and genotyping;] rapid diagnostic assays for testing of respiratory [removed: infections;] [added: infections at the point of care;] microbiology laboratory automation; and plated media for clinical and industrial applications. | | |
| Surgery | | | Hernia and soft tissue repair, biological grafts, bioresorbable grafts, biosurgery, and other surgical [removed: products;] [added: products,] BD ChloraPrep™ surgical infection prevention [removed: products;] [added: products,] and V. Mueller™ surgical and laparoscopic instrumentation products. | | |
| Peripheral Intervention | | | Percutaneous transluminal angioplasty (“PTA”) balloon catheters, [added: radio frequency ablation catheters,] peripheral vascular stents, self-expanding and balloon-expandable stent grafts, vascular grafts, drug coated balloons, ports, biopsy, chronic dialysis, feeding, inferior vena catheter filters, endovascular fistula creation devices and drainage products, and atherectomy and thrombectomy systems. | | |
Additional information regarding this [removed: divestiture] [added: acquisition] is contained in Note [removed: 10] [added: 11] to the consolidated financial statements contained in Item 8.
Geographic information with respect to BD’s operations is included under the heading “Geographic Information” in Note [removed: 7] [added: 8] to the consolidated financial statements included in Item 8.
BD’s products are marketed and distributed in the United States and internationally through independent distribution channels, [removed: and] [added: as well as] directly to hospitals and other healthcare [added: related] institutions by BD and independent sales representatives.
BD uses acute care, non-acute care, laboratory and drug wholesaler distributors to broadly support our overall disposable product demand from our end user customers in the United [removed: States.][added: States, while our capital equipment is mostly sold direct to our end user customers.]
Order backlog is not [added: usually] material to BD’s business inasmuch as orders for BD products generally are received and filled on a current basis.
If clinical trials are not required, this qualification process [added: can take 3-18 months depending on the criticality of the change.]
New companies have entered the field, particularly in the areas of molecular diagnostics, [added: non-traditional point of care and at-home testing,] safety-engineered devices and in the life sciences, and established companies have diversified their business activities into the medical technology area.
In order to remain competitive in the industries in which it operates, BD continues to make investments in R&D, quality management, quality improvement, product [removed: innovation] [added: innovation, manufacturing] and [added: supply chain investments to boost supply reliability and] productivity improvement in support of its core strategies.
These mechanisms include payment reductions, pay for performance measures, quality-based performance payments, restrictive coverage policies, bidding and tender mechanics, studies to compare the effectiveness of therapies and use of technology [removed: assessments.]
We see other governments around the world considering similar bundling reform measures, with the utilization of the Diagnosis Related Group (“DRG”) as a payment mechanism to drive toward quality and [removed: resource based] [added: resource-based] reimbursement becoming more common in regions outside the U.S.
BD's operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, [added: occupational health and safety,] antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), export control, product safety and efficacy, employment, privacy and other areas.
BD actively maintains [removed: FDA/ISO] Quality Systems that establish standards for its product design, manufacturing, and distribution [removed: processes.][added: processes, in accordance with ISO standards and FDA regulation.]
Prior to marketing or selling most of its products, BD must secure [removed: approval] [added: authorization] from the FDA and counterpart [removed: non-U.S.] [added: foreign] regulatory agencies.
[added: Following the introduction of a product,] these agencies engage in periodic reviews and inspections of BD’s quality systems, as well as product performance and advertising and promotional materials.
These agencies [removed: possess] [added: have] the authority to take various administrative and legal actions against BD, such as product recalls, product seizures and other civil and criminal [removed: sanctions.][added: sanctions, for violations of applicable requirements.]
In addition, [removed: as part of PPACA,] the federal government has enacted the Sunshine Act provisions requiring BD to publicly report gifts and payments made to physicians and teaching hospitals.
Countries outside the United States have enacted similar local laws requiring medical device companies to report transfers of value to [removed: health care] [added: healthcare] providers licensed in those countries.
In February 2009, CareFusion and the FDA amended the consent decree [added: (the “Consent Decree”)] to include all infusion pumps manufactured by or for CareFusion 303, Inc., the organizational unit that manufactures and sells BD Alaris™ infusion pumps in the United States.
The [removed: amended consent decree] [added: Consent Decree] does not apply to intravenous administration sets and accessories.
[removed: However, we cannot predict the outcome of this matter, and the amended consent decree] [added: The Consent Decree] authorizes the FDA, in the event of any violations in the future, to order us to cease manufacturing and distributing infusion pumps, recall products and take other actions.
We may be required to pay damages of $15,000 per day per violation if we fail to comply with any provision of the [removed: amended consent decree,] [added: Consent Decree,] up to $15 million per year.
[removed: We also] [added: Additionally, we] cannot currently predict [removed: whether] [added: the amount of] additional monetary investment [added: that] will be incurred to resolve this matter or the matter’s ultimate impact on our business.
We may be obligated to pay more costs in the future because, among other things, the FDA may determine that we are not fully compliant with the [removed: amended consent decree] [added: Consent Decree] and [added: Non-Compliance Letter and] therefore impose penalties under the [removed: amended consent decree,] [added: Consent Decree,] and/or we may [added: also] be subject to future proceedings and litigation relating to the matters addressed in the [removed: amended consent decree,] [added: Consent Decree,] including, but not limited to, [added: additional] fines, penalties, other monetary remedies, and expansion of the terms of the [removed: amended consent decree.][added: Consent Decree.]
As of September 30, [removed: 2021,] [added: 2022,] we do not believe that a loss is probable in connection with the [removed: amended consent decree,] [added: Consent Decree,] and accordingly, we have no accruals associated with compliance with the [removed: amended consent decree.][added: Consent Decree.]
We are undertaking certain remediation of our BD [removed: Alaris] [added: Alaris™] System, and are currently shipping the product in the [removed: U.S.,] [added: U.S.] only in cases of medical necessity and to remediate recalled software versions.
We will not be able to fully resume commercial operations for the BD [removed: Alaris] [added: Alaris™] System in the U.S. until [removed: a] [added: BD’s] 510(k) submission relating to the product has been cleared by the FDA.
Following an inspection that began in March 2020 of our Medication Management Systems facility (CareFusion 303, Inc.) in San Diego, California, the FDA issued to BD a Form 483 Notice [added: (the “Form 483 Notice”)] that contains a number of observations of [removed: non-conformance.][added: non-conformance with the FDA’s quality system regulations.]
The FDA review of these remaining commitments is [removed: ongoing] [added: ongoing,] and no assurances can be given regarding further action by the FDA as a result of these commitments, including but not limited to action pursuant to the Warning Letter.
[removed: Consent] [added: Ethylene Oxide/Consent] Order - Covington, Georgia, USA
Under the terms of the consent order, which has been amended two times upon mutual agreement of BD and EPD, BD voluntarily agreed to a number of operational changes at its Covington and Madison, Georgia facilities, as well as at its distribution center in Covington, designed to further reduce ethylene oxide emissions, including but not limited to operating at a reduced [removed: capacity.][added: capacity until successful implementation of fugitive emission control technology, ongoing ambient air monitoring and operational controls at such facilities.]
[removed: At a broader level, several states have increased the regulatory requirements associated with the use and emission of ethylene oxide, the most frequently used sterilant for medical devices and health care products in the U.S.] This increased regulation could require BD or sterilization service providers, including providers used by BD, to temporarily suspend operations to install additional [removed: air quality controls,] [added: fugitive emissions control technology,] limit the use of ethylene oxide or take other actions, which would [added: impact BD’s operations and] further reduce the available capacity [removed: of third-party providers] to sterilize medical devices and [removed: health care products.][added: healthcare products, and could also result in additional costs.]
[removed: In] [added: For example, in] December 2020, the State of New Mexico filed a lawsuit seeking a temporary restraining order and a preliminary and permanent injunction against a major medical device sterilizer, which sterilizes certain of our surgery products, to reduce ethylene oxide emissions associated with their sterilization process.
On the federal level, in late 2019, the U.S. Environmental Protection Agency provided notice that it would be conducting rulemaking to reconsider federal regulations applicable to the use and emission of ethylene [removed: oxide.][added: oxide, and there continues to be increased focus on the use and emission of ethylene oxide on the federal level.]
[added: It is possible that there may also be increased regulation outside the U.S.] If any [added: existing regulatory requirements or any] such proceedings or rulemaking result in the suspension [added: 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 [removed: products.][added: products or lead to civil litigation or other claims against BD.]
Acquisition
On July 18, 2022, BD completed the acquisition of Parata Systems (“Parata”), an innovative provider of pharmacy automation solutions, for total cash consideration of $1.548 billion.
Since the acquisition date, financial results for Parata's product offerings are being reported within results for the Medical segment’s Medication Management Solutions unit.
Spin-Off of Diabetes Care
On April 1, 2022, BD completed the separation and distribution of Embecta Corp. (“Embecta”), formerly BD's Diabetes Care business, into a separate, publicly-traded company.
The historical results of the Diabetes Care business (previously included in BD’s Medical segment), as well as interest expense related to indebtedness incurred by Embecta prior to the spin-off date, have been reflected as discontinued operations in our consolidated financial statements for all periods prior to the spin-off date of April 1, 2022.
Additional disclosures regarding our spin-off of the Diabetes Care business are provided in Note 2 to the consolidated financial statements contained in Item 8.
Financial Statements and Supplementary Data, which is incorporated herein by reference.
assessments.
In December 2021, the FDA issued to CareFusion 303, Inc. a letter of non-compliance with respect to the Consent Decree (the “Non-Compliance Letter”) stating that, among other things, it had determined that certain of BD’s corrective actions with respect to the Form 483 Notice appeared to be adequate, some were still in progress such that adequacy could not be determined yet, and certain others were not adequate (e.g., complaint handling and corrective and preventive actions (“CAPA”), design verification and medical device reporting).
Per the terms of the Non-Compliance Letter, CareFusion 303, Inc. provided the FDA with a proposed comprehensive corrective action plan and has retained an independent expert to conduct periodic audits of the CareFusion 303, Inc. infusion pump facilities over the next four years.
CareFusion 303, Inc. will update its corrective action plan to address any observations that may arise during the course of these audits.
The FDA’s review of the items raised in the Form 483 Notice and Non-Compliance Letter remains ongoing, and no assurances can be given regarding further action by the FDA as a result of the observations, including but not limited to action pursuant to the Consent Decree, or that corrective actions proposed by CareFusion 303, Inc. will be adequate to address these observations.
As previously disclosed, we submitted our 510(k) premarket notification to the FDA for the BD Alaris™ System in April 2021.
The 510(k) submission is intended to bring the regulatory clearance for the BD Alaris™ System up-to-date, address open recall issues, and provide other updates and features, including a new version of BD Alaris™ System software that will provide clinical, operational and cybersecurity updates.
In January 2022, BD received FDA clearance for
its BD Vacutainer® ACD Blood Collection Tubes used in immunohematology.
Following submission of data relating to the implementation of these operational changes, BD was permitted to return to normal operations in December 2021 at its facilities in Georgia in accordance with the operating conditions set forth in its permit applications, including a condition to continue ambient air monitoring.
However, BD’s sterilization operations in Georgia remain subject to the EPD’s final approval of BD’s air permit applications and could be subject to additional restrictions.
At a broader level, there is increased focus on the use and emission of ethylene oxide by the U.S. Environmental Protection Agency and state environmental regulatory agencies.
Additional regulatory requirements associated with the use and emission of ethylene oxide may be imposed in the future, either domestically or outside the U.S. Ethylene oxide is the most frequently used sterilant for medical devices and healthcare products in the U.S., and in certain cases is the only option to sterilize critical medical device products for the safe administration to patients.
In anticipation of these proposed revisions to federal air regulations for commercial sterilizers in the U.S., BD is installing fugitive emissions controls at our facilities in East Columbus, NE and Sandy, UT.
We strive to have our workforce reflect the communities we live and work in and the customers and patients we serve.
In addition, our executive leaders serve as sponsors to our eight global Associate Resource Groups (“ARGs”).
Our ARGs are empowered to set strategic goals aligned with their mission and centered around efforts to advance our company, our local communities and each BD associates’ career, while driving acceptance, allyship and professional development opportunities.
We remain committed to sustaining meaningful, long-term strategic partnerships and programs to help ensure that we are advancing the health of our people and patient communities.
Through the BD Helping Build Healthy Communities™ initiative, which is funded by BD and the BD Foundation, and implemented jointly by Direct Relief and the National Association of Community Health Centers, we have provided 52 awards to community health centers in 20 states since 2013, with a total commitment of $22.6 million in cash and product donations to advance health equity in the U.S.
While we celebrate the recognition we have received, we remain committed and accountable to the work required within our company and beyond our corporate walls to build belonging, acceptance and equity for all.
| Executive | | | 31% | | | +1% | | | 23% | | | +3% | | |
| Management | | | 41% | | | +1% | | | 30% | | | +1% | | |
At BD we hold ourselves and each other accountable for learning and growing every day, which underscores our growth mindset culture.
We have also applied our growth mindset philosophy to our performance management approach with an increased focus on continuous learning and development.
On a local front, associates are
Our total rewards program is designed to attract and retain top talent and to incentivize performance aligned with our business strategy and values.
Through our integrated global approach to well-being, we provide support, education, and resources to empower associates across all geographies to prioritize their well-being and build resilience in the physical, emotional, financial, and social areas of life.
Aligned with our priority focus on pay equity, we regularly conduct comprehensive audits, internal and external analyses, salary benchmarking and bias assessments to identify and remedy unexplained disparities.
For fiscal year 2021, we conducted a global pay equity assessment for associates in 57 countries, representing approximately 70% of BD’s global salaried associate population and found that our female associates in 2021 earned an average of 99 cents for every $1 earned by male associates in the U.S., and 98 cents globally.
We consider these results as a baseline for our commitment to achieving 100% gender pay equity and we are actively working to close remaining pay gaps.
| Diabetes Care | | | Syringes, pen needles and other products related to the injection or infusion of insulin and other drugs used in the treatment of diabetes. | | |
Divestiture
*Advanced Bioprocessing*
In October 2018, BD completed the sale of its Life Sciences segment’s Advanced Bioprocessing business pursuant to a definitive agreement that was signed in September 2018.
can take 3-18 months depending on the criticality of the change.
Following the introduction of a product,
While this BD organizational unit remains subject to the amended consent decree, which includes the requirements of the original consent decree, it has made substantial progress in its compliance efforts.
BD has provided the FDA with its response to the Form 483 and has begun to implement certain corrective actions to address the observations.
However, the FDA’s review of the items raised in the Form 483 remains ongoing and no assurances can be given regarding further action by
the FDA as a result of the observations, including but not limited to action pursuant to the amended consent decree.
BD does not believe that the consent order will have a material impact on its operations.
Violation of the consent order, though, could subject us to additional restrictions on the sterilization operations at our Covington and Madison facilities.
In addition, our executive leaders serve as sponsors of our nine associate-led resource groups ("ARGs") who are empowered to set strategic goals that drive belonging, allyship, community service and professional development.
We remain committed to support and partner with the United Nation’s Open for Business, United Negro College Fund, the Equal Justice Initiative (“EJI”) and our BD Helping Build Healthy Communities initiative.
Through the BD Helping Build Healthy Communities™ initiative, we committed $22.6 million to support Direct Relief and the National Association of Community Health Centers in expanding the innovative practices of U.S. community health centers, which collectively serve more than 30 million U.S. patients, the majority of which are in underserved communities.
We also built upon our support for the EJI, taking the opportunity to engage our associates in a 21-Day Racial Equity and Social Justice Challenge to bring further awareness and understanding of social and racial justice issues.
For each associate that engaged with the challenge, we committed an additional monetary donation to the EJI.
| Executive | | | 30% | | | +2% | | | 20% | | | — | | |
| Management | | | 40% | | | +1% | | | 29% | | | +1% | | |
At BD we are accountable for learning and growing every day.
Our commitment to continuous improvement helps us to become the best version of ourselves.
We have launched an enhanced Strategic Organizational Planning process in order to build the organizational capabilities required in the years to come.
We have, in addition, conducted several virtual programs for our Executive Leaders to support them in their role as company leaders responsible for navigating the pandemic.
We believe in and encourage in our associates and leaders a Growth Mindset, a belief that qualities and talents can be developed through dedication and hard work, and have aligned our performance management system to support our culture evolution and increased focus on continuous learning and development.
As a result of the COVID-19 pandemic, we also further strengthened our digital communication and social networking platforms.
Our communications throughout the pandemic have kept our associates informed on critical priorities, important actions being taken by management in response to the pandemic, and continued efforts to protect associate health, safety and well-being.
We are committed to rewarding, supporting, and developing the associates who make it possible to deliver on our strategy.
To that end, we offer a comprehensive total rewards program aimed at promoting
For 2021, we conducted a pay equity assessment for associates in 57 countries to identify and remedy any potential pay disparity issues.
An excerpt. Shown here: 40 of 66 rewritten, all 38 added and all 29 removed. The counts are complete. For every sentence, read Item 1. Business. in the FY2022 filing and the FY2021 filing.
Item 3. Legal Proceedings.
1 rewritten, 0 added, 0 removed, 1 unchanged
Information with respect to certain legal proceedings is included in Note [removed: 5] [added: 6] to the consolidated financial statements contained in Item 8.
Cover and table of contents
26 rewritten, 7 added, 7 removed, 57 unchanged
For the fiscal year ended September 30, [removed: 2021][added: 2022]
As of March 31, [removed: 2021,] [added: 2022,] the aggregate market value of the registrant’s outstanding common stock held by non-affiliates of the registrant was approximately [removed: $70,616,222,365.][added: $74,865,947,637.]
As of October 31, [removed: 2021, 284,023,582] [added: 2022, 283,375,793] shares of the registrant’s common stock were outstanding.
Documents Incorporated by [removed: Reference] [added: Reference.] Portions of the registrant’s Proxy Statement for the Annual Meeting of Shareholders to be held January [removed: 25, 2022] [added: 24, 2023] are incorporated by reference into Part III hereof.
| [Item 1. [removed: Business](#i769337f517694ce29a72abc52f207787_16)] [added: Business](#ia87db9e40d284890bdb9962ca233dca1_16)] | | | [removed: [1](#i769337f517694ce29a72abc52f207787_16)] [added: [1](#ia87db9e40d284890bdb9962ca233dca1_16)] | | |
| [Item 1A. Risk [removed: Factors](#i769337f517694ce29a72abc52f207787_19)] [added: Factors](#ia87db9e40d284890bdb9962ca233dca1_19)] | | | [removed: [11](#i769337f517694ce29a72abc52f207787_19)] [added: [12](#ia87db9e40d284890bdb9962ca233dca1_19)] | | |
| [Item 1B. Unresolved Staff [removed: Comments](#i769337f517694ce29a72abc52f207787_22)] [added: Comments](#ia87db9e40d284890bdb9962ca233dca1_22)] | | | [removed: [21](#i769337f517694ce29a72abc52f207787_22)] [added: [25](#ia87db9e40d284890bdb9962ca233dca1_22)] | | |
| [Item 2. [removed: Properties](#i769337f517694ce29a72abc52f207787_25)] [added: Properties](#ia87db9e40d284890bdb9962ca233dca1_25)] | | | [removed: [21](#i769337f517694ce29a72abc52f207787_25)] [added: [25](#ia87db9e40d284890bdb9962ca233dca1_25)] | | |
| [Item 3. Legal [removed: Proceedings](#i769337f517694ce29a72abc52f207787_28)] [added: Proceedings](#ia87db9e40d284890bdb9962ca233dca1_28)] | | | [removed: [21](#i769337f517694ce29a72abc52f207787_28)] [added: [25](#ia87db9e40d284890bdb9962ca233dca1_28)] | | |
| [Item 4. Mine Safety [removed: Disclosures](#i769337f517694ce29a72abc52f207787_31)] [added: Disclosures](#ia87db9e40d284890bdb9962ca233dca1_31)] | | | [removed: [21](#i769337f517694ce29a72abc52f207787_31)] [added: [25](#ia87db9e40d284890bdb9962ca233dca1_31)] | | |
| [Information About Our Executive [removed: Officers](#i769337f517694ce29a72abc52f207787_34)] [added: Officers](#ia87db9e40d284890bdb9962ca233dca1_34)] | | | [removed: [22](#i769337f517694ce29a72abc52f207787_34)] [added: [24](#ia87db9e40d284890bdb9962ca233dca1_34)] | | |
| [Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i769337f517694ce29a72abc52f207787_40)] [added: Securities](#ia87db9e40d284890bdb9962ca233dca1_40)] | | | [removed: [23](#i769337f517694ce29a72abc52f207787_40)] [added: [26](#ia87db9e40d284890bdb9962ca233dca1_40)] | | |
| [Item 6. [removed: (Reserved)](#i769337f517694ce29a72abc52f207787_43)] [added: (Reserved)](#ia87db9e40d284890bdb9962ca233dca1_43)] | | | [removed: [23](#i769337f517694ce29a72abc52f207787_43)] [added: [26](#ia87db9e40d284890bdb9962ca233dca1_43)] | | |
| [Item 7. Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i769337f517694ce29a72abc52f207787_46)] [added: Operations](#ia87db9e40d284890bdb9962ca233dca1_46)] | | | [removed: [24](#i769337f517694ce29a72abc52f207787_46)] [added: [27](#ia87db9e40d284890bdb9962ca233dca1_46)] | | |
| [Item 7A. Quantitative and Qualitative Disclosures About Market [removed: Risk](#i769337f517694ce29a72abc52f207787_49)] [added: Risk](#ia87db9e40d284890bdb9962ca233dca1_49)] | | | [removed: [47](#i769337f517694ce29a72abc52f207787_49)] [added: [50](#ia87db9e40d284890bdb9962ca233dca1_49)] | | |
| [Item 8. Financial Statements and Supplementary [removed: Data](#i769337f517694ce29a72abc52f207787_52)] [added: Data](#ia87db9e40d284890bdb9962ca233dca1_52)] | | | [removed: [48](#i769337f517694ce29a72abc52f207787_52)] [added: [51](#ia87db9e40d284890bdb9962ca233dca1_52)] | | |
| [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial [removed: Disclosure](#i769337f517694ce29a72abc52f207787_142)] [added: Disclosure](#ia87db9e40d284890bdb9962ca233dca1_133)] | | | [removed: [102](#i769337f517694ce29a72abc52f207787_142)] [added: [106](#ia87db9e40d284890bdb9962ca233dca1_133)] | | |
| [Item 9A. Controls and [removed: Procedures](#i769337f517694ce29a72abc52f207787_145)] [added: Procedures](#ia87db9e40d284890bdb9962ca233dca1_136)] | | | [removed: [102](#i769337f517694ce29a72abc52f207787_145)] [added: [106](#ia87db9e40d284890bdb9962ca233dca1_136)] | | |
| [Item 9B. Other [removed: Information](#i769337f517694ce29a72abc52f207787_148)] [added: Information](#ia87db9e40d284890bdb9962ca233dca1_139)] | | | [removed: [103](#i769337f517694ce29a72abc52f207787_148)] [added: [107](#ia87db9e40d284890bdb9962ca233dca1_139)] | | |
| [Item [removed: 9C.](#i769337f517694ce29a72abc52f207787_1531) [](#i769337f517694ce29a72abc52f207787_1531)[Disclosure] [added: 9C. Disclosure] Regarding Foreign Jurisdictions that Prevent [removed: Inspections](#i769337f517694ce29a72abc52f207787_1531)] [added: Inspections](#ia87db9e40d284890bdb9962ca233dca1_142)] | | | [removed: [103](#i769337f517694ce29a72abc52f207787_1531)] [added: [107](#ia87db9e40d284890bdb9962ca233dca1_142)] | | |
| [Item 10. Directors, Executive Officers and Corporate [removed: Governance](#i769337f517694ce29a72abc52f207787_154)] [added: Governance](#ia87db9e40d284890bdb9962ca233dca1_148)] | | | [removed: [103](#i769337f517694ce29a72abc52f207787_154)] [added: [108](#ia87db9e40d284890bdb9962ca233dca1_148)] | | |
| [Item 11. Executive [removed: Compensation](#i769337f517694ce29a72abc52f207787_157)] [added: Compensation](#ia87db9e40d284890bdb9962ca233dca1_151)] | | | [removed: [103](#i769337f517694ce29a72abc52f207787_157)] [added: [108](#ia87db9e40d284890bdb9962ca233dca1_151)] | | |
| [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i769337f517694ce29a72abc52f207787_160)] [added: Matters](#ia87db9e40d284890bdb9962ca233dca1_154)] | | | [removed: [103](#i769337f517694ce29a72abc52f207787_160)] [added: [108](#ia87db9e40d284890bdb9962ca233dca1_154)] | | |
| [Item 13. Certain Relationships and Related Transactions, and Director [removed: Independence](#i769337f517694ce29a72abc52f207787_163)] [added: Independence](#ia87db9e40d284890bdb9962ca233dca1_157)] | | | [removed: [103](#i769337f517694ce29a72abc52f207787_163)] [added: [108](#ia87db9e40d284890bdb9962ca233dca1_157)] | | |
| [Item 14. Principal Accounting Fees and [removed: Services](#i769337f517694ce29a72abc52f207787_166)] [added: Services](#ia87db9e40d284890bdb9962ca233dca1_160)] | | | [removed: [104](#i769337f517694ce29a72abc52f207787_166)] [added: [108](#ia87db9e40d284890bdb9962ca233dca1_160)] | | |
| [Item 15. Exhibits, Financial Statement [removed: Schedules](#i769337f517694ce29a72abc52f207787_172)] [added: Schedules](#ia87db9e40d284890bdb9962ca233dca1_166)] | | | [removed: [104](#i769337f517694ce29a72abc52f207787_172)] [added: [109](#ia87db9e40d284890bdb9962ca233dca1_166)] | | |
| [PART I](#ia87db9e40d284890bdb9962ca233dca1_13) | | | [1](#ia87db9e40d284890bdb9962ca233dca1_13) | | |
| [PART II](#ia87db9e40d284890bdb9962ca233dca1_37) | | | [26](#ia87db9e40d284890bdb9962ca233dca1_37) | | |
| [PART III](#ia87db9e40d284890bdb9962ca233dca1_145) | | | [108](#ia87db9e40d284890bdb9962ca233dca1_148) | | |
| [PART IV](#ia87db9e40d284890bdb9962ca233dca1_163) | | | [108](#ia87db9e40d284890bdb9962ca233dca1_163) | | |
| [Item 16. Form 10-K Summary](#ia87db9e40d284890bdb9962ca233dca1_169) | | | [109](#ia87db9e40d284890bdb9962ca233dca1_166) | | |
| [EXHIBIT INDEX](#ia87db9e40d284890bdb9962ca233dca1_172) | | | [110](#ia87db9e40d284890bdb9962ca233dca1_172) | | |
| [SIGNATURES](#ia87db9e40d284890bdb9962ca233dca1_175) | | | [115](#ia87db9e40d284890bdb9962ca233dca1_175) | | |
| [PART I](#i769337f517694ce29a72abc52f207787_13) | | | [1](#i769337f517694ce29a72abc52f207787_13) | | |
| [PART II](#i769337f517694ce29a72abc52f207787_37) | | | [23](#i769337f517694ce29a72abc52f207787_37) | | |
| [PART III](#i769337f517694ce29a72abc52f207787_151) | | | [103](#i769337f517694ce29a72abc52f207787_154) | | |
| [PART IV](#i769337f517694ce29a72abc52f207787_169) | | | [104](#i769337f517694ce29a72abc52f207787_169) | | |
| [Item 16. Form 10-K Summary](#i769337f517694ce29a72abc52f207787_175) | | | [104](#i769337f517694ce29a72abc52f207787_172) | | |
| [EXHIBIT INDEX](#i769337f517694ce29a72abc52f207787_178) | | | [105](#i769337f517694ce29a72abc52f207787_178) | | |
| [SIGNATURES](#i769337f517694ce29a72abc52f207787_181) | | | [110](#i769337f517694ce29a72abc52f207787_181) | | |
Item 2. Properties.
5 rewritten, 0 added, 0 removed, 10 unchanged
As of September [removed: 2021,] [added: 30, 2022,] BD owned or leased [removed: 325] [added: 334] facilities throughout the world, comprising approximately [removed: 25,018,032] [added: 25,651,266] square feet of manufacturing, warehousing, administrative, and research facilities.
The U.S. facilities, including those in Puerto Rico, comprise approximately [removed: 7,966,863] [added: 8,020,022] square feet of owned and [removed: 4,501,209] [added: 4,666,986] square feet of leased space.
The international facilities comprise approximately [removed: 9,638,055] [added: 9,556,871] square feet of owned and [removed: 2,911,904] [added: 3,407,387] square feet of leased space.
The U.S. facilities are located in Alabama, Arizona, California, [added: Colorado,] Connecticut, Florida, Georgia, Illinois, [added: Indiana,] Maryland, Massachusetts, [removed: Minnesota,] Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington D.C., Washington, [added: Wisconsin,] and Puerto Rico.
\- *Greater Asia*, which includes facilities in Australia, Bangladesh, China, India, Indonesia, Japan, Malaysia, New Zealand, [added: Pakistan,] the Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam.
Item 4. Mine Safety Disclosures.
0 rewritten, 0 added, 18 removed, 2 unchanged
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.
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Name | | | Age | | | Position | | |
| Thomas E. Polen | | | 48 | | | 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. | | |
| Simon D. Campion | | | 50 | | | Executive Vice President and President, Interventional Segment since September 2018; Worldwide President, BD Interventional - Surgery from December 2017 to September 2018; President, Davol (now part of our Surgery business), C.R. Bard, Inc. from July 2015 to December 2017; and prior thereto, Vice President and General Manager, Davol. | | |
| Alexandre Conroy | | | 58 | | | Executive Vice President and Chief Integrated Supply Chain Officer since February 2019; Worldwide President, Medication and Procedural Solutions from May 2017 to February 2019; and Executive Vice President and President, Europe, EMA and the Americas from June 2012 to May 2017. | | |
| Christopher J. DelOrefice | | | 50 | | | Executive Vice President and Chief Financial Officer since September 2021; Vice President, Investor Relations, Johnson & Johnson from August 2018 to August 2021; Vice President, Finance, North America Hospital Medical Devices, Johnson & Johnson from June 2017 to August 2018; and Vice President, Finance, North America, Johnson & Johnson Consumer, March 2014 to June 2017. | | |
| Antoine C. Ezell | | | 52 | | | Executive Vice President, President, North America 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. | | |
| Roland Goette | | | 59 | | | Executive Vice President and President, EMEA since May 2017; and President, Europe from October 2014 to May 2017. | | |
| David Hickey | | | 59 | | | Executive Vice President and President, Life Sciences Segment since January 2021; President, Integrated Diagnostics Solutions from October 2019 to January 2021; and President, Diagnostic Systems from July 2016 to September 2019. | | |
| Samrat S. Khichi | | | 54 | | | Executive Vice President, Corporate Development, Public Policy, Regulatory Affairs and General Counsel since September 2021; Executive Vice President, Public Policy, Regulatory Affairs and General Counsel from May 2019 to September 2021; Executive Vice President and General Counsel from December 2017 to May 2019; and Senior Vice President, General Counsel and Corporate Secretary, C.R. Bard, Inc. from July 2014 to December 2017. | | |
| Betty D. Larson | | | 45 | | | Executive Vice President and Chief Human Resources Officer since July 2018; Senior Vice President of Human Resources, Interventional Segment from December 2017 to July 2018; and Vice President, Human Resources, Chief Human Resources Officer, C.R. Bard, Inc. from September 2014 to December 2017. | | |
| James Lim | | | 57 | | | Executive Vice President and President, Greater Asia since June 2012. | | |
| Alberto Mas | | | 60 | | | Executive Vice President and President - Medical Segment since June 2018; Executive Vice President and President - Life Sciences Segment from October 2016 to June 2018; and Worldwide President - Diagnostic Systems from October 2013 to October 2016. | | |
| Christopher R. Reidy | | | 64 | | | Executive Vice President and Chief Administrative Officer since September 2021; and Executive Vice President, Chief Financial Officer and Chief Administrative Officer from July 2013 to September 2021. | | |
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
5 rewritten, 4 added, 9 removed, 6 unchanged
As of October 31, [removed: 2021,] [added: 2022,] there were approximately [removed: 11,998] [added: 11,400] shareholders of record.
The table below sets forth certain information regarding BD’s purchases of its common stock during the fiscal quarter ended September 30, [removed: 2021.][added: 2022.]
(2)The repurchases were made pursuant to the repurchase program authorized by the Board of Directors on September 24, 2013 for 10 million shares, [added: which has been fully utilized as of September 30, 2022, and a repurchase program authorized by the Board of Directors in November 2021] for [added: up to an additional 10 million shares of BD common stock, for] which there is no expiration date.
Additional disclosures regarding our share repurchase transactions are provided in Note [removed: 3] [added: 4] to the consolidated financial statements contained in Item 8.
[removed: (4)Includes] [added: (1)Shares purchased includes] an initial delivery of [removed: 2,515,000] [added: 1,573,378] shares of our common stock received [added: in August 2022] upon payment [removed: under an ASR agreement] of [removed: $750] [added: $500] million [added: under an accelerated share repurchase (“ASR”) agreement,] which was executed in August [removed: 2021.][added: 2022, and an additional 379,755 shares in September 2022 based upon final settlement of the ASR agreement.]
| July 1-31, 2022 | | | — | | | | | | — | | | | | | — | | | | | | 10,753,131 | | |
| August 1-31, 2022 | | | 1,573,378 | | | | | | $256.00 | | | | | | 1,573,378 | | | | | | 9,179,753 | | |
| September 1-30, 2022 | | | 379,755 | | | | | | $256.00 | | | | | | 379,755 | | | | | | 8,799,998 | | |
| Total | | | 1,953,133 | | | | | | $256.00 | | | | | | 1,953,133 | | | | | | 8,799,998 | | |
| July 1-31, 2021 (3) | | | 404,392 | | | | | | $242.56 | | | | | | 403,159 | | | | | | 3,730,494 | | |
| August 1-31, 2021 (4) | | | 2,515,405 | | | | | | $251.90 | | | | | | 2,515,301 | | | | | | 1,215,193 | | |
| September 1-30, 2021 | | | — | | | | | | — | | | | | | — | | | | | | 1,215,193 | | |
| Total | | | 2,919,797 | | | | | | $250.61 | | | | | | 2,918,460 | | | | | | 1,215,193 | | |
(1)Includes shares purchased during the quarter in open market transactions by the trust relating to BD’s Deferred Compensation and Retirement Benefit Restoration Plan and 1996 Directors’ Deferral Plan.
(3)Includes 403,000 shares received upon final settlement of a $500 million accelerated share repurchase (“ASR”) agreement executed in May 2021.
The total average price paid per share in the table above reflects the volume weighted average price of BD's shares over the term of the ASR agreement.
We received an additional 462,000 shares in October 2021 based upon final settlement of the ASR agreement.
In November 2021, the Board of Directors authorized BD to repurchase up to an additional 10 million shares of BD common stock, for which there is no expiration date.
Item 8. Financial Statements and Supplementary Data.
528 rewritten, 336 added, 232 removed, 862 unchanged
The Board of Directors monitors the internal control system, including internal accounting and financial reporting controls, through its Audit Committee, which consists of [removed: eight] [added: four] independent Directors.
Based on the Company's assessment of the effectiveness of internal control over financial reporting and the criteria noted above, management concluded that internal control over financial reporting was effective as of September 30, [removed: 2021.][added: 2022.]
We have audited the accompanying consolidated balance sheets of Becton, Dickinson and Company (the Company) as of September 30, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] the related consolidated statements of income, comprehensive income and cash flows for each of the three years in the period ended September 30, [removed: 2021,] [added: 2022,] and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at September 30, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended September 30, [removed: 2021,] [added: 2022,] in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of September 30, [removed: 2021,] [added: 2022,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated November [removed: 24, 2021] [added: 22, 2022] expressed an unqualified opinion thereon.
| *Description of the Matter* | | | As described in Note [removed: 5] [added: 6] to the consolidated financial statements, the Company is a defendant in various product liability matters in which the plaintiffs allege a wide variety of claims associated with the use of certain Company devices. At September 30, [removed: 2021,] [added: 2022,] the Company’s product liability reserves totaled approximately [removed: $2.5] [added: $2.1] billion. The Company engaged an actuarial specialist to perform an analysis to estimate the outstanding liability for indemnity costs related to claims arising from these product liability matters. The methods used by the Company to estimate these reserves are based on reported claims, historical settlement amounts, and stage of litigation, among other items. Auditing management’s estimate of certain of the Company’s product liability reserves and the related disclosure was challenging due to the significant judgment required to determine the methods used to estimate the amount of unreported product liability claims and the indemnity costs and the key assumptions utilized in those methods given the stages of these matters and the amount of claims history. | | |
| [removed: How] [added: *How] We Addressed the Matter in Our [removed: Audit] [added: Audit*] | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over [removed: the Company’s income tax provision process, such as controls over] management’s [removed: identification and assessment of changes to tax laws, regulations and income tax positions to account] [added: accounting] for uncertain tax positions, including [removed: management’s review] [added: assessment] of the [removed: related tax] technical [removed: analyses. We performed audit procedures, among others, to] [added: merits of tax positions. To] evaluate [added: whether] the [removed: Company’s assumptions used to develop its] [added: technical merits of] uncertain tax positions [removed: and related unrecognized income tax benefit amounts by jurisdiction. We obtained an understanding of the Company’s legal structure through] [added: are more likely than not sustainable,] our [removed: review of organizational charts and related legal documents. We further considered the income tax consequences of significant transactions, including internal restructurings, and assessed management’s interpretation] [added: audit procedures included, among others, evaluation] of [removed: those changes under the relevant jurisdiction’s] [added: applicable] tax [removed: law. Due to the complexity of income] [added: law,] tax [removed: laws] [added: regulations] and [removed: regulations, we involved] [added: other regulatory guidance by] our tax subject matter [removed: professionals to assess the Company’s interpretation of and compliance with tax laws and regulations in these jurisdictions, as well as to identify changes in tax laws and regulations.] [added: professionals.] We also involved our tax subject matter professionals [removed: to evaluate the technical merits] [added: in verifying our understanding] of the [removed: Company’s accounting for its tax positions, including] [added: relevant facts and analysis, by] assessing the Company’s correspondence with the relevant tax authorities and evaluating third-party advice obtained by the Company. We also evaluated the [added: adequacy of the] Company’s income tax disclosures included in Note [removed: 16] [added: 17] to the consolidated financial statements in relation to these matters. | | |
| /s/ [added: | | |] ERNST & YOUNG LLP | | | | | |
| We have served as the Company's auditor since 1959. | | | | | | [added: | | |]
| New York, New York | | | | | | [added: | | |]
We have audited Becton, Dickinson and Company’s internal control over financial reporting as of September 30, [removed: 2021,] [added: 2022,] based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), (the COSO criteria).
In our opinion, Becton, Dickinson and Company (the Company) maintained, in all material respects, effective internal control over financial reporting as of September 30, [removed: 2021,] [added: 2022,] based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of September 30, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] the related consolidated statements of income, comprehensive income and cash flows for each of the three years in the period ended September 30, [removed: 2021,] [added: 2022,] and the related notes and our report dated November [removed: 24, 2021] [added: 22, 2022] expressed an unqualified opinion thereon.
| Millions of dollars, except per share amounts | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |
| Cost of products sold | | | [removed: 10,821] [added: $] | [added: 46] | | | | | [removed: 9,540] [added: $] | [added: 43] | | | | | [removed: 9,002] [added: $] | [added: 40] | |
| Selling and administrative expense | | | [removed: 4,867] [added: 78] | | | | | | [removed: 4,325] [added: 148] | | | | | | [removed: 4,332] [added: 141] | | |
| Research and development expense | | | [removed: 1,339] [added: 32] | | | | | | [removed: 1,096] [added: 59] | | | | | | [removed: 1,062] [added: 57] | | |
| Acquisitions and other restructurings | | | [removed: 185] [added: 1] | | | | | | [removed: 309] [added: 1] | | | | | | [removed: 480] [added: 20] | | |
| Other operating expense, net | | | [removed: 238] [added: 37] | | | | | | [removed: 363] [added: 203] | | | | | | [removed: 654] [added: 363] | | |
| Total Operating Costs and Expenses | | | [removed: 17,449] [added: 16,588] | | | | | | [removed: 15,633] [added: 16,881] | | | | | | [removed: 15,530] [added: 15,161] | | |
| Interest expense | | | [removed: (469)] [added: (398)] | | | | | | [removed: (528)] [added: (469)] | | | | | | [removed: (639)] [added: (528)] | | |
| Interest income | | | [removed: 9] [added: 16] | | | | | | [removed: 7] [added: 9] | | | | | | [removed: 12] [added: 7] | | |
| Other (expense) income, net | | | [removed: (97)] [added: (117)] | | | | | | [removed: 23] [added: (99)] | | | | | | [removed: 43] [added: 23] | | |
| Income tax provision [removed: (benefit)] | | | [removed: 150] [added: 42] | | | | | | [removed: 111] [added: 62] | | | | | | [removed: (57)] [added: 50] | | |
| Net Income | | | [removed: 2,092] [added: 1,779] | | | | | | [removed: 874] [added: 2,092] | | | | | | [removed: 1,233] [added: 874] | | |
| Preferred stock dividends | | | (90) | | | | | | [removed: (107)] [added: (90)] | | | | | | [removed: (152)] [added: (107)] | | |
| Net income applicable to common shareholders | | | $ | [removed: 2,002] [added: 1,689] | | | | | $ | [removed: 767] [added: 2,002] | | | | | $ | [removed: 1,082] [added: 767] | |
| Basic Earnings per Share | | | $ | [removed: 6.92] [added: 5.93] | | | | | $ | [removed: 2.75] [added: 6.92] | | | | | $ | [removed: 4.01] [added: 2.75] | |
| Diluted Earnings per Share | | | $ | [removed: 6.85] [added: 5.88] | | | | | $ | [removed: 2.71] [added: 6.85] | | | | | $ | [removed: 3.94] [added: 2.71] | |
| Millions of dollars | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |
| Net Income | | | $ | [removed: 2,092] [added: 1,779] | | | | | $ | [removed: 874] [added: 2,092] | | | | | $ | [removed: 1,233] [added: 874] | |
| Foreign currency translation adjustments | | | [removed: 124] [added: 305] | | | | | | [removed: (161)] [added: 124] | | | | | | [removed: (93)] [added: (161)] | | |
| Defined benefit pension and postretirement plans | | | [removed: 255] [added: 210] | | | | | | [removed: (35)] [added: 255] | | | | | | [removed: (275)] [added: (35)] | | |
| Cash flow hedges | | | [removed: 81] [added: 85] | | | | | | [removed: (67)] [added: 81] | | | | | | [removed: (6)] [added: (67)] | | |
| Other Comprehensive Income (Loss), Net of Tax | | | [removed: 460] [added: 600] | | | | | | [removed: (265)] [added: 460] | | | | | | [removed: (374)] [added: (265)] | | |
| Comprehensive Income | | | $ | [removed: 2,552] [added: 2,379] | | | | | $ | [removed: 609] [added: 2,552] | | | | | $ | [removed: 859] [added: 609] | |
| Millions of dollars, except per share amounts and numbers of shares | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |
| Cash and equivalents | | | $ | [removed: 2,283] [added: 1,006] | | | | | $ | [removed: 2,825] [added: 2,283] | |
| Restricted cash | | | [removed: 109] [added: 153] | | | | | | [removed: 92] [added: 109] | | |
| Short-term investments | | | [removed: 12] [added: 8] | | | | | | [removed: 20] [added: 12] | | |
| *Description of the Matter* | | | As discussed in Notes 1 and 17 to the consolidated financial statements, the Company conducts business in numerous countries and as a result, files tax returns in those locations. Uncertain tax positions may arise for multiple reasons including, but not limited to, the interpretation of global tax rules and regulations. The Company uses judgment to (1) determine whether, based on the technical merits, a tax position is more likely than not to be sustained and (2) measure the amount of tax benefit that qualifies for recognition. The Company has recorded a liability of $348 million related to uncertain tax positions as of September 30, 2022. Due to the inherent uncertainty in predicting the resolution of these tax matters, auditing the Company’s uncertain tax positions involved complex analysis and auditor judgment. This also required the use of tax subject matter resources to determine whether the more likely than not criteria was met. | | |
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| November 22, 2022 | | | | | | | | |
| November 22, 2022 | | | | | |
| Revenues | | | $ | 18,870 | | | | | $ | 19,131 | | | | | $ | 16,074 | |
| Selling and administrative expense | | | 4,709 | | | | | | 4,719 | | | | | | 4,185 | | |
| Research and development expense | | | 1,256 | | | | | | 1,279 | | | | | | 1,039 | | |
| Acquisition-related integration and restructuring expense | | | 192 | | | | | | 179 | | | | | | 299 | | |
| Operating Income | | | 2,282 | | | | | | 2,250 | | | | | | 912 | | |
| Income from Continuing Operations Before Income Taxes | | | 1,783 | | | | | | 1,692 | | | | | | 414 | | |
| Net Income from Continuing Operations | | | 1,635 | | | | | | 1,604 | | | | | | 352 | | |
| Income from Discontinued Operations, Net of Tax | | | 144 | | | | | | 488 | | | | | | 522 | | |
| Basic Earnings per Share | | | | | | | | | | | | | | | | | |
| Income from Continuing Operations | | | $ | 5.42 | | | | | $ | 5.23 | | | | | $ | 0.88 | |
| Income from Discontinued Operations | | | 0.50 | | | | | | 1.69 | | | | | | 1.87 | | |
| Diluted Earnings per Share | | | | | | | | | | | | | | | | | |
| Income from Continuing Operations | | | $ | 5.38 | | | | | $ | 5.18 | | | | | $ | 0.87 | |
| Income from Discontinued Operations | | | 0.50 | | | | | | 1.67 | | | | | | 1.85 | | |
| Trade receivables, net | | | 2,191 | | | | | | 2,350 | | |
| Current assets of discontinued operations | | | — | | | | | | 293 | | |
| Property, Plant and Equipment, Net | | | 6,012 | | | | | | 6,003 | | |
| Goodwill | | | 24,621 | | | | | | 23,886 | | |
| Other Assets | | | 1,848 | | | | | | 1,945 | | |
| Noncurrent Assets of Discontinued Operations | | | — | | | | | | 423 | | |
| Current debt obligations | | | $ | 2,179 | | | | | $ | 500 | |
| Accounts payable | | | 1,699 | | | | | | 1,739 | | |
| Accrued expenses | | | 2,605 | | | | | | 2,867 | | |
| Salaries, wages and related items | | | 1,171 | | | | | | 1,186 | | |
| Current liabilities of discontinued operations | | | — | | | | | | 157 | | |
| Deferred Income Taxes and Other Liabilities | | | 5,052 | | | | | | 5,209 | | |
| Noncurrent Liabilities of Discontinued Operations | | | — | | | | | | 17 | | |
| Treasury stock — 81,283,191 shares in 2022 and 80,163,949 shares in 2021. | | | (8,330) | | | | | | (7,723) | | |
| Net income | | | $ | 1,779 | | | | | $ | 2,092 | | | | | $ | 874 | |
| Less: Income from discontinued operations, net of tax | | | 144 | | | | | | 488 | | | | | | 522 | | |
| Income from continuing operations, net of tax | | | 1,635 | | | | | | 1,604 | | | | | | 352 | | |
| Depreciation and amortization | | | 2,229 | | | | | | 2,230 | | | | | | 2,115 | | |
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| Description of the Matter | | | As discussed in Notes 1 and 16 of the consolidated financial statements, the Company has recorded a liability of $447 million related to uncertain tax positions as of September 30, 2021. The Company conducts business in numerous countries and is therefore subject to income taxes in multiple jurisdictions, which impacts the provision for income taxes. Due to the multinational operations of the Company, changes in global income tax laws and regulations result in complexity in the accounting for and monitoring of income taxes including the provision for uncertain tax positions. Auditing the completeness of management’s identification of uncertain tax positions involved complex analysis and auditor judgment related to the evaluation of the income tax consequences of significant transactions, including internal restructurings, and changes in income tax laws and regulations in various jurisdictions, which is often subject to interpretation. | | |
| | | | Goodwill impairment — Interventional segment | | |
| *Description of the Matter* | | | At September 30, 2021, the Company’s goodwill assigned to the Interventional segment was $12.8 billion. As discussed in Note 1 of the consolidated financial statements, goodwill is tested for impairment at least annually at the reporting unit level using quantitative models. Auditing management’s annual goodwill impairment test was complex and highly judgmental due to the significant estimation required in determining the fair value of the reporting units. In particular, the fair value estimates were sensitive to significant assumptions such as the revenue growth rate and discount rate, which are affected by expectations about future market or economic conditions. | | |
| *How We Addressed the Matter in Our Audit* | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s goodwill impairment review process. For example, we tested controls over management’s review of the inputs and assumptions to the goodwill impairment analysis. To test the estimated fair value of the Company’s reporting units, our audit procedures included, among others, assessing fair value methodology, evaluating the prospective financial information used by the Company in its valuation analysis and involving our valuation specialists to assist in testing the significant assumptions discussed above. We compared the significant assumptions used by management to current industry and economic trends, historical financial results, and other relevant factors that would affect the significant assumptions. We assessed the historical accuracy of management’s estimates and performed sensitivity analyses of significant assumptions to evaluate the changes in the fair value of the reporting units. In addition, we tested the reconciliation of the fair value of the reporting units to the market capitalization of the Company. | | |
| November 24, 2021 | | | | | |
| Revenues | | | $ | 20,248 | | | | | $ | 17,117 | | | | | $ | 17,290 | |
| Operating Income | | | 2,799 | | | | | | 1,484 | | | | | | 1,760 | | |
| Income Before Income Taxes | | | 2,242 | | | | | | 985 | | | | | | 1,176 | | |
| | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Goodwill | | | 23,901 | | | | | | 23,620 | | |
| Common stock in treasury — at cost — 80,163,949 shares in 2021 and 74,622,657 shares in 2020. | | | (7,723) | | | | | | (6,138) | | |
| Depreciation and amortization | | | 2,273 | | | | | | 2,154 | | | | | | 2,253 | | |
| Deferred income taxes | | | (304) | | | | | | (302) | | | | | | (381) | | |
| Inventories | | | (104) | | | | | | (125) | | | | | | (149) | | |
| Gain on sale of business | | | — | | | | | | — | | | | | | (336) | | |
| Capital expenditures | | | (1,231) | | | | | | (810) | | | | | | (957) | | |
| Proceeds from divestitures, net | | | — | | | | | | — | | | | | | 477 | | |
BD’s Intention to Spin Off Diabetes Care
On May 6, 2021, the Company announced its intention to spin off its Diabetes Care business as a separate publicly traded company to BD’s shareholders.
The proposed spin-off is intended to be a tax-free transaction for U.S. federal income tax purposes and is expected to be completed in the first half of calendar year 2022, subject to the satisfaction of customary conditions, including final approval from BD’s Board of Directors and the effectiveness of a registration statement on Form 10.
On October 1, 2020, the Company retrospectively adopted an accounting standard update which added, removed and clarified disclosure requirements relating to defined benefit plans and other postretirement plans.
See Note 9 for the Company’s defined pension plan and other benefit plan disclosures.
In July 2018, the FASB issued accounting standard update (“ASU”) ASU 2018-09, "Codification Improvements", which, among other items, amended an illustrative example of a fair value hierarchy disclosure to indicate that a certain type of investment should not always be considered to be eligible to use the net asset value ("NAV") per share practical expedient.
Also, it further clarified that an entity should evaluate whether a readily determinable fair value exists or whether its investments qualify for the NAV practical expedient.
The Company early adopted this standard in the fourth quarter of fiscal year 2020 on a prospective basis, which is reflected in the fair value hierarchy classification of pension assets in Note 9, but does not change the fair value measurements of the investments.
In August 2018, the FASB issued a new accounting standard to align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for
capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal use software license).
The Company early adopted this standard as of April 1, 2020 on a prospective basis.
In February 2016, the FASB issued a new lease accounting standard which requires lessees to recognize lease assets and lease liabilities on the balance sheet, as well as expanded disclosures regarding leasing arrangements.
The Company adopted this standard on October 1, 2019, and elected certain practical expedients permitted under the transition guidance, including a transition method which allows application of the new standard at its adoption date, rather than at the earliest comparative period presented in the financial statements.
The Company also elected not to perform any reassessments relative to its expired and existing leases upon its adoption of the new requirements.
The Company's adoption of this standard did not materially impact its consolidated financial statements.
On October 1, 2018, the Company adopted Accounting Standards Codification Topic 606, "Revenue from Contracts with Customers" ("ASC 606") using the modified retrospective method.
Under ASC 606, revenue is recognized upon the transfer of control of goods or services to customers and reflects the amount of consideration to which a reporting entity expects to be entitled in exchange for those goods or services.
The Company assessed the impact of this new standard on its consolidated financial statements based upon a review of contracts that were not completed as of October 1, 2018.
This accounting standard adoption, which is further discussed in Note 6, did not materially impact any line items of the Company's consolidated income statements and balance sheet.
On October 1, 2018, the Company retrospectively adopted an accounting standard update which requires all components of net periodic pension and postretirement benefit costs to be disaggregated from the service cost component and to be presented on the income statement outside a subtotal of income from operations, if one is presented.
An excerpt. Shown here: 40 of 528 rewritten, 40 of 336 added and 40 of 232 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data. in the FY2022 filing and the FY2021 filing.
Item 9A. Controls and Procedures.
3 rewritten, 1 added, 1 removed, 2 unchanged
An evaluation was conducted by BD’s management, with the participation of BD’s Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of BD’s disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934) as of September 30, [removed: 2021.][added: 2022.]
[removed: Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the] design and operation of these disclosure controls and procedures were, as of the end of the period covered by this report, effective and designed to ensure that material information relating to BD and its consolidated subsidiaries would be made known to them by others within these entities.
There were no changes in our internal control over financial reporting during the fiscal quarter ended September 30, [removed: 2021] [added: 2022] identified in [added: connection with the above-referenced evaluation that have materially affected, or are reasonably likely to materially affect, BD’s internal control over financial reporting.]
Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the
connection with the above-referenced evaluation that have materially affected, or are reasonably likely to materially affect, BD’s internal control over financial reporting.
Item 10. Directors, Executive Officers and Corporate Governance.
3 rewritten, 0 added, 0 removed, 1 unchanged
The information relating to BD’s directors and nominees for director required by this item will be contained under the caption “Proposal 1: Election of Directors” in a definitive proxy statement involving the election of directors, which the registrant will file with the SEC not later than 120 days after September 30, [removed: 2021] [added: 2022] (the [removed: “2022] [added: “2023] Proxy Statement”), and such information is incorporated herein by reference.
Information relating to the Audit Committee of the BD Board of Directors required by this item will be contained under the caption “The Board and committees of the Board - Audit Committee”, and information regarding BD’s code of ethics required by this item will be contained under the heading “The Board and committees of the Board - ESG - Code of Conduct”, in BD’s [removed: 2022] [added: 2023] Proxy statement, and such information is incorporated herein by reference.
Certain other information required by this item will be contained under the caption “Ownership of BD Common Stock” in BD’s [removed: 2022] [added: 2023] Proxy Statement, and such information is incorporated herein by reference.
Item 11. Executive Compensation.
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this item will be contained under the captions “Executive Compensation,” “Report of the Compensation and Human Capital Committee,” “Compensation of Named Executive Officers”, “Non‑management director compensation,” and “CEO Pay Ratio" in BD’s [removed: 2022] [added: 2023] Proxy Statement, and such information is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this item will be contained under the caption “Ownership of BD Common Stock” in BD’s [removed: 2022] [added: 2023] Proxy Statement, and such information is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this item will be contained under the caption “The Board and committees of the Board - Related [removed: persons] [added: person] transactions” in BD’s [removed: 2022] [added: 2023] Proxy Statement, and such information is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services.
1 rewritten, 0 added, 0 removed, 2 unchanged
Ratification of Selection of Independent Registered Public Accounting Firm” in BD’s [removed: 2022] [added: 2023] Proxy Statement, and such information is incorporated herein by reference.
Item 15. Exhibits, Financial Statement Schedules.
6 rewritten, 0 added, 0 removed, 7 unchanged
◦Reports of Independent Registered Public Accounting Firm [added: (PCAOB ID: 42)]
◦Consolidated Statements of Income — Years ended September 30, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019][added: 2020]
◦Consolidated Statements of Comprehensive Income — Years ended September 30, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019][added: 2020]
◦Consolidated Balance Sheets — September 30, [removed: 2021] [added: 2022] and [removed: 2020][added: 2021]
◦Consolidated Statements of Cash Flows — Years ended September 30, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019][added: 2020]
See Note [removed: 18] [added: 19] to the Consolidated Financial Statements included in Item 8.
Item 16. Form 10-K Summary
49 rewritten, 4 added, 8 removed, 99 unchanged
| [removed: [3(c)](https://www.sec.gov/Archives/edgar/data/0000010795/000001079521000073/by-lawsasofseptember2820.htm)] [added: [3(c)](https://www.sec.gov/Archives/edgar/data/10795/000001079522000065/by-lawsasofseptember202022.htm)] | | | | | | By-Laws, as amended as of September [removed: 28, 2021.] [added: 20, 2022.] | | | | | | Incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K filed on [removed: October 4, 2021.] [added: September 23, 2022.] | | |
| [removed: [4(](http://www.sec.gov/Archives/edgar/data/10795/000095012310104702/y87674exv4w2.htm)[e](http://www.sec.gov/Archives/edgar/data/10795/000095012310104702/y87674exv4w2.htm)[)](http://www.sec.gov/Archives/edgar/data/10795/000095012310104702/y87674exv4w2.htm)] [added: [4(e)](http://www.sec.gov/Archives/edgar/data/10795/000095012310104702/y87674exv4w2.htm)] | | | | | | Form of 5.000% Notes due November 12, 2040. | | | | | | Incorporated by reference to Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on November 12, 2010. | | |
| [removed: [4(](http://www.sec.gov/Archives/edgar/data/10795/000119312514442073/d837485dex44.htm)[f](http://www.sec.gov/Archives/edgar/data/10795/000119312514442073/d837485dex44.htm)[)](http://www.sec.gov/Archives/edgar/data/10795/000119312514442073/d837485dex44.htm)] [added: [4(f)](http://www.sec.gov/Archives/edgar/data/10795/000119312514442073/d837485dex44.htm)] | | | | | | Form of 3.734% Notes due December 15, 2024. | | | | | | Incorporated by reference to Exhibit 4.4 to the registrant’s Current Report on Form 8-K filed on December 15, 2014. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000119312514442073/d837485dex45.htm)[g](https://www.sec.gov/Archives/edgar/data/10795/000119312514442073/d837485dex45.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000119312514442073/d837485dex45.htm)] [added: [4(g)](https://www.sec.gov/Archives/edgar/data/10795/000119312514442073/d837485dex45.htm)] | | | | | | Form of 4.685% Notes due December 15, 2044. | | | | | | Incorporated by reference to Exhibit 4.5 to the registrant’s Current Report on Form 8-K filed on December 15, 2014. | | |
| [removed: [4(](http://www.sec.gov/Archives/edgar/data/10795/000119312515156851/d915554dex45.htm)[h](http://www.sec.gov/Archives/edgar/data/10795/000119312515156851/d915554dex45.htm)[)](http://www.sec.gov/Archives/edgar/data/10795/000119312515156851/d915554dex45.htm)] [added: [4(h)](http://www.sec.gov/Archives/edgar/data/10795/000119312515156851/d915554dex45.htm)] | | | | | | Form of 3.875% Senior Notes due May 15, 2024. | | | | | | Incorporated by reference to Exhibit 4.5 to the registrant’s Current Report on Form 8-K filed on April 29, 2015. | | |
| [removed: [4(](http://www.sec.gov/Archives/edgar/data/10795/000119312515156851/d915554dex46.htm)[i](http://www.sec.gov/Archives/edgar/data/10795/000119312515156851/d915554dex46.htm)[)](http://www.sec.gov/Archives/edgar/data/10795/000119312515156851/d915554dex46.htm)] [added: [4(i)](http://www.sec.gov/Archives/edgar/data/10795/000119312515156851/d915554dex46.htm)] | | | | | | Form of 4.875% Senior Notes due May 15, 2044. | | | | | | Incorporated by reference to Exhibit 4.6 to the registrant’s Current Report on Form 8-K filed on April 29, 2015. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000119312516789747/d310032dex41.htm)[j](https://www.sec.gov/Archives/edgar/data/10795/000119312516789747/d310032dex41.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000119312516789747/d310032dex41.htm)] [added: [4(j)](https://www.sec.gov/Archives/edgar/data/10795/000119312516789747/d310032dex41.htm)] | | | | | | Form of 1.000% Notes due December 15, 2022. | | | | | | Incorporated by reference to Exhibit 4.1 to the registrant's Current Report on Form 8-K filed on December 9, 2016. | | |
| [removed: [4(l)](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-4.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-5.htm)[l](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-5.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-5.htm)] | | | | | | Form of [removed: Floating Rate] [added: 3.363%] Notes due June 6, [removed: 2022.] [added: 2024.] | | | | | | Incorporated by reference to Exhibit [removed: 4.4] [added: 4.5] to the registrant’s Current Report on Form 8-K filed on June 6, 2017. | | |
| [removed: [4](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-5.htm)[(](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-5.htm)[m](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-5.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-5.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-6.htm)[m](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-6.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-6.htm)] | | | | | | Form of [removed: 3.363%] [added: 3.700%] Notes due June 6, [removed: 2024.] [added: 2027.] | | | | | | Incorporated by reference to Exhibit [removed: 4.5] [added: 4.6] to the registrant’s Current Report on Form 8-K filed on June 6, 2017. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-6.htm)[n](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-6.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-6.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-7.htm)[n](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-7.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-7.htm)] | | | | | | Form of [removed: 3.700%] [added: 4.669%] Notes due June 6, [removed: 2027.] [added: 2047.] | | | | | | Incorporated by reference to Exhibit [removed: 4.6] [added: 4.7] to the registrant’s Current Report on Form 8-K filed on June 6, 2017. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-7.htm)[o](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-7.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036117024005/s001721x2_ex4-7.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000119312517383523/d517273dex44.htm)[r](https://www.sec.gov/Archives/edgar/data/10795/000119312517383523/d517273dex44.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000119312517383523/d517273dex44.htm)] | | | | | | Form of [removed: 4.669%] [added: 6.700%] Notes due [removed: June 6, 2047.] [added: December 1, 2026.] | | | | | | Incorporated by reference to Exhibit [removed: 4.7] [added: 4.4] to the [removed: registrant’s] [added: registrant's] Current Report on Form 8-K filed on [removed: June 6,] [added: December 29,] 2017. | | |
| [removed: [4(](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)[p](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)[)](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)] [added: [4(](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)[o](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)[)](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)] | | | | | | Form of Certificate for the 6.000% Mandatory Convertible Preferred Stock, Series B. | | | | | | Incorporated by reference to Exhibit 4.2 to the registrant’s registration statement on Form 8-A filed on May 26, 2020. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036120012446/nt10012113x7_ex4-3.htm)[q](https://www.sec.gov/Archives/edgar/data/10795/000114036120012446/nt10012113x7_ex4-3.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036120012446/nt10012113x7_ex4-3.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036120012446/nt10012113x7_ex4-3.htm)[p](https://www.sec.gov/Archives/edgar/data/10795/000114036120012446/nt10012113x7_ex4-3.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036120012446/nt10012113x7_ex4-3.htm)] | | | | | | Deposit Agreement, dated as of May 26, 2020, among Becton, Dickinson and Company and Computershare Inc. and Computershare Trust Company, N.A., acting jointly as depositary and Computershare Trust Company, N.A., acting as Registrar and Transfer Agent, on behalf of the holders from time to time of the depositary receipts described therein. | | | | | | Incorporated by reference to Exhibit 4.3 to the registrant’s registration statement on Form 8-A filed on May 26, 2020. | | |
| [removed: [4(](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)[r](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)[)](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)] [added: [4(](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)[q](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)[)](http://www.sec.gov/Archives/edgar/data/10795/000156761917001035/s001681x3_8a12b.htm)] | | | | | | Form of Depositary Receipt for the Depositary Shares. | | | | | | Incorporated by reference to Exhibit 4.4 to the registrant’s registration statement on Form 8-A filed on May 26, 2020. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000119312517383523/d517273dex44.htm)[t](https://www.sec.gov/Archives/edgar/data/10795/000119312517383523/d517273dex44.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000119312517383523/d517273dex44.htm)] [added: [4](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-4.htm)[(](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-4.htm)[z](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-4.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-4.htm)] | | | | | | Form of [removed: 6.700% Notes] [added: 1.208% Note] due [removed: December 1,] [added: June 4,] 2026. | | | | | | Incorporated by reference to Exhibit 4.4 to the registrant's Current Report on Form 8-K filed on [removed: December 29, 2017.] [added: June 4, 2019.] | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/9892/0000009892-96-000013.txt)[u](https://www.sec.gov/Archives/edgar/data/9892/0000009892-96-000013.txt)[)](https://www.sec.gov/Archives/edgar/data/9892/0000009892-96-000013.txt)] [added: [4(](https://www.sec.gov/Archives/edgar/data/9892/0000009892-96-000013.txt)[s](https://www.sec.gov/Archives/edgar/data/9892/0000009892-96-000013.txt)[)](https://www.sec.gov/Archives/edgar/data/9892/0000009892-96-000013.txt)] | | | | | | Indenture, dated as of December 1, 1996 between C.R. Bard, Inc. and The Bank of New York Mellon Trust Company, N.A., a national banking association, as trustee. | | | | | | Incorporated by reference to Exhibit 4.1 to C.R. Bard, Inc.'s Registration Statement on Form S-3 (File No. 333-05997). | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/9892/000119312517179095/d377270dex42.htm)[v](https://www.sec.gov/Archives/edgar/data/9892/000119312517179095/d377270dex42.htm)[)](https://www.sec.gov/Archives/edgar/data/9892/000119312517179095/d377270dex42.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/9892/000119312517179095/d377270dex42.htm)[t](https://www.sec.gov/Archives/edgar/data/9892/000119312517179095/d377270dex42.htm)[)](https://www.sec.gov/Archives/edgar/data/9892/000119312517179095/d377270dex42.htm)] | | | | | | First Supplemental Indenture, dated May 18, 2017, between C. R. Bard, Inc. and The Bank of New York Mellon Trust Company, N.A., as trustee. | | | | | | Incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K of C.R. Bard, Inc. filed on May 23, 2017. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-1.htm)[w](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-1.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-1.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-1.htm)[u](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-1.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-1.htm)] | | | | | | Form of 1.401% Notes due May 24, 2023. | | | | | | Incorporated by reference to Exhibit 4.1 to the registrant's Current Report on Form 8-K filed on May 24, 2018. | | |
| [removed: [4(x)](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-2.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-2.htm)[v](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-2.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036118025542/s002291x1_ex4-2.htm)] | | | | | | Form of 3.020% Notes due May 24, 2025. | | | | | | Incorporated by reference to Exhibit 4.2 to the registrant's Current Report on Form 8-K filed on May 24, 2018. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-1.htm)[y](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-1.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-1.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-1.htm)[x](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-1.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-1.htm)] | | | | | | First Supplemental Indenture, dated as of June 4, 2019, among Becton Finance, as issuer, Becton, Dickinson and Company, as guarantor, and The Bank of New York Mellon Trust Company, N.A., as trustee. | | | | | | Incorporated by reference to Exhibit 4.1 to the registrant's Current Report on Form 8-K filed on June 4, 2019. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-3.htm)[z](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-3.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-3.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-3.htm)[y](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-3.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-3.htm)] | | | | | | Form of 0.632% Note due June 4, 2023. | | | | | | Incorporated by reference to Exhibit 4.3 to the registrant's Current Report on Form 8-K filed on June 4, 2019. | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-4.htm)[aa](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-4.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036119010401/nc10002034x4_ex4-4.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036121004715/nt10019789x8_ex4-2.htm)[ee](https://www.sec.gov/Archives/edgar/data/10795/000114036121004715/nt10019789x8_ex4-2.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036121004715/nt10019789x8_ex4-2.htm)] | | | | | | Form of [removed: 1.208%] [added: 1.213%] Note due [removed: June 4, 2026.] [added: February 12, 2036.] | | | | | | Incorporated by reference to Exhibit [removed: 4.4] [added: 4.2] to the registrant's Current Report on Form 8-K filed on [removed: June 4, 2019.] [added: February 12, 2021.] | | |
| [removed: [4(bb)](https://www.sec.gov/Archives/edgar/data/10795/000114036120012072/nc10012106x1_ex4-1.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036120012072/nc10012106x1_ex4-1.htm)[aa](https://www.sec.gov/Archives/edgar/data/10795/000114036120012072/nc10012106x1_ex4-1.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036120012072/nc10012106x1_ex4-1.htm)] | | | | | | Form of 2.823% Notes due May 20, 2030. | | | | | | Incorporated by reference to Exhibit 4.1 to the registrant’s Current Report on Form 8-K filed on May 20, 2020. | | |
| [removed: [4(cc)](https://www.sec.gov/Archives/edgar/data/10795/000114036120012072/nc10012106x1_ex4-2.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036120012072/nc10012106x1_ex4-2.htm)[bb](https://www.sec.gov/Archives/edgar/data/10795/000114036120012072/nc10012106x1_ex4-2.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036120012072/nc10012106x1_ex4-2.htm)] | | | | | | Form of 3.794% Notes due May 20, 2050. | | | | | | Incorporated by reference to Exhibit 4.2 to the registrant’s Current Report on Form 8-K filed on May 20, 2020. | | |
| [removed: [4(dd)](https://www.sec.gov/Archives/edgar/data/10795/000114036121004377/nt10019789x6_ex4-1.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036121004377/nt10019789x6_ex4-1.htm)[cc](https://www.sec.gov/Archives/edgar/data/10795/000114036121004377/nt10019789x6_ex4-1.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036121004377/nt10019789x6_ex4-1.htm)] | | | | | | Form of 1.957% Notes due February 11, 2031. | | | | | | Incorporated by reference to Exhibit 4.1 to the registrant's Current Report on Form 8-K filed on February 11, 2021. | | |
| [removed: [4(ee)](https://www.sec.gov/Archives/edgar/data/10795/000114036121004715/nt10019789x8_ex4-1.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036121004715/nt10019789x8_ex4-1.htm)[dd](https://www.sec.gov/Archives/edgar/data/10795/000114036121004715/nt10019789x8_ex4-1.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036121004715/nt10019789x8_ex4-1.htm)] | | | | | | Second Supplemental Indenture, dated as of February 12, 2021, among Becton Finance, as issuer, Becton, Dickinson and Company, as guarantor, and The Bank of New York Mellon Trust Company, N.A., as trustee. | | | | | | Incorporated by reference to Exhibit 4.1 to the registrant's Current Report on Form 8-K filed on February 12, 2021. | | |
| [removed: [4(ff)](https://www.sec.gov/Archives/edgar/data/10795/000114036121004715/nt10019789x8_ex4-2.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-2.htm)[gg](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-2.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-2.htm)] | | | | | | Form of [removed: 1.213% Note] [added: 0.334% Notes] due [removed: February 12, 2036.] [added: August 13, 2028.] | | | | | | Incorporated by reference to Exhibit 4.2 to the registrant's Current Report on Form 8-K filed on [removed: February 12,] [added: August 13,] 2021. | | |
| [removed: [4(gg)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-1.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-1.htm)[ff](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-1.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-1.htm)] | | | | | | Third Supplemental Indenture, dated as of August 13, 2021, among Becton Finance, as issuer, Becton, Dickinson and Company, as guarantor, and The Bank of New York Mellon Trust Company, N.A., as trustee. | | | | | | Incorporated by reference to Exhibit 4.1 to the registrant's Current Report on Form 8-K filed on August 13, 2021. | | |
| [removed: [4(hh)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-2.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-3.htm)[hh](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-3.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-3.htm)] | | | | | | Form of [removed: 0.334%] [added: 1.336%] Notes due August 13, [removed: 2028.] [added: 2041.] | | | | | | Incorporated by reference to Exhibit [removed: 4.2] [added: 4.3] to the registrant's Current Report on Form 8-K filed on August 13, 2021. | | |
| [removed: [4(ii)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028306/ny20000253x8_ex4-3.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036121028170/ny20000253x9_ex4-3.htm)[jj](https://www.sec.gov/Archives/edgar/data/10795/000114036121028170/ny20000253x9_ex4-3.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028170/ny20000253x9_ex4-3.htm)] | | | | | | Form of [removed: 1.336%] [added: 0.034%] Notes due August 13, [removed: 2041.] [added: 2025.] | | | | | | Incorporated by reference to Exhibit 4.3 to the [removed: registrant's Current Report] [added: registrant’s registration statement] on Form [removed: 8-K] [added: 8-A] filed on August 13, 2021. | | |
| [removed: [4(jj)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028170/ny20000253x9_ex4-2.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036121028170/ny20000253x9_ex4-2.htm)[ii](https://www.sec.gov/Archives/edgar/data/10795/000114036121028170/ny20000253x9_ex4-2.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028170/ny20000253x9_ex4-2.htm)] | | | | | | Form of 0.000% Notes due August 13, 2023. | | | | | | Incorporated by reference to Exhibit 4.2 to the registrant’s registration statement on Form 8-A filed on August 13, 2021. | | |
| [removed: [4(kk)](https://www.sec.gov/Archives/edgar/data/10795/000114036121028170/ny20000253x9_ex4-3.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036122030495/ny20004957x5_ex4-1.htm)[kk](https://www.sec.gov/Archives/edgar/data/10795/000114036122030495/ny20004957x5_ex4-1.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036122030495/ny20004957x5_ex4-1.htm)] | | | | | | Form of [removed: 0.034%] [added: 4.298%] Notes due August [removed: 13, 2025.] [added: 22, 2032.] | | | | | | Incorporated by reference to Exhibit [removed: 4.3] [added: 4.1] to the [removed: registrant’s registration statement] [added: registrant's Current Report] on Form [removed: 8-A] [added: 8-K] filed on August [removed: 13, 2021.] [added: 22, 2022.] | | |
| [removed: [4(](https://www.sec.gov/Archives/edgar/data/10795/000001079521000091/a09-30x2021ex4ll.htm)[ll](https://www.sec.gov/Archives/edgar/data/10795/000001079521000091/a09-30x2021ex4ll.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000001079521000091/a09-30x2021ex4ll.htm)] [added: [4(](https://www.sec.gov/Archives/edgar/data/10795/000162828022030686/a09-30x2022ex4ll.htm)[ll](https://www.sec.gov/Archives/edgar/data/10795/000162828022030686/a09-30x2022ex4ll.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000162828022030686/a09-30x2022ex4ll.htm)] | | | | | | Description of the Registrant’s Securities. | | | | | | Filed with this report. | | |
| [removed: [10(c)](http://www.sec.gov/Archives/edgar/data/10795/000001079517000008/ex10103312017.htm)] [added: [10(g)(i)](https://www.sec.gov/Archives/edgar/data/10795/000001079522000017/ex10a2004employeeanddirect.htm)] | | | | | | [removed: Performance Incentive] [added: 2004 Employee and Director Equity-Based Compensation] Plan, as amended and restated [removed: January 24, 2017.*] [added: as of November 23, 2021.*] | | | | | | Incorporated by reference to Exhibit [removed: 10.1] [added: 10(a)] to the [removed: registrant's] [added: registrant’s] Quarterly Report on Form 10-Q for the period ended [removed: March] [added: December] 31, [removed: 2017.] [added: 2021.] | | |
| [removed: [10(g)(i)](https://www.sec.gov/Archives/edgar/data/10795/000001079520000055/a9-30x2020ex10ginextgen.htm)] [added: [10(j)](https://www.sec.gov/Archives/edgar/data/10795/000001079518000036/a2018-09x30ex10o.htm)] | | | | | | [removed: 2004 Employee and Director Equity-Based Compensation Plan, as amended] [added: Term sheet, dated August 25, 2017, between the registrant] and [removed: restated as of November 24, 2020.*] [added: Samrat Khichi.*] | | | | | | Incorporated by reference to Exhibit [removed: 10(g)(i)] [added: 10(o)] to the registrant’s Annual Report on Form 10-K for the fiscal year ended September 30, [removed: 2020.] [added: 2018.] | | |
| [removed: [10(](https://www.sec.gov/Archives/edgar/data/10795/000001079518000036/a2018-09x30ex10o.htm)[j](https://www.sec.gov/Archives/edgar/data/10795/000001079518000036/a2018-09x30ex10o.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000001079518000036/a2018-09x30ex10o.htm)] [added: [10(n)](https://www.sec.gov/Archives/edgar/data/10795/000001079521000091/a09-30x2021ex10n.htm)] | | | | | | [removed: Term sheet,] [added: Letter Agreement,] dated August [removed: 25, 2017,] [added: 4, 2021,] between the registrant and [removed: Samrat Khichi.*] [added: Christopher DelOrefice.*] | | | | | | Incorporated by reference to Exhibit [removed: 10(o)] [added: 10(n)] to the registrant’s Annual Report on Form 10-K for the fiscal year ended September 30, [removed: 2018.] [added: 2021.] | | |
| [removed: [1](https://www.sec.gov/Archives/edgar/data/9892/0000009892-94-000009.txt)[0(](https://www.sec.gov/Archives/edgar/data/9892/0000009892-94-000009.txt)[k](https://www.sec.gov/Archives/edgar/data/9892/0000009892-94-000009.txt)[)](https://www.sec.gov/Archives/edgar/data/9892/0000009892-94-000009.txt)] [added: [10(k)](https://www.sec.gov/Archives/edgar/data/9892/0000009892-94-000009.txt)] | | | | | | C. R. Bard, Inc. Supplemental Executive Retirement Plan, dated as of July 13, 1988.* | | | | | | Incorporated by reference to Exhibit 10p to the C.R. Bard, Inc. Annual Report on Form 10-K for the fiscal year ended December 31, 1993. | | |
| [removed: [10(](https://www.sec.gov/Archives/edgar/data/9892/000119312505213110/dex10be.htm)[l)](https://www.sec.gov/Archives/edgar/data/9892/000119312505213110/dex10be.htm)] [added: [10(l)](https://www.sec.gov/Archives/edgar/data/9892/000119312505213110/dex10be.htm)] | | | | | | Supplemental Insurance/Retirement Plan Agreement (as Amended and Restated) between C.R. Bard, Inc. and its executive officers.* | | | | | | Incorporated by reference to Exhibit 10be to the C.R. Bard, Inc. Quarterly Report on Form 10-Q for the period ended September 30, 2005. | | |
| [removed: [10(](https://www.sec.gov/Archives/edgar/data/9892/000119312511044634/dex10bw.htm)[m](https://www.sec.gov/Archives/edgar/data/9892/000119312511044634/dex10bw.htm)[)](https://www.sec.gov/Archives/edgar/data/9892/000119312511044634/dex10bw.htm)] [added: [10(m)](https://www.sec.gov/Archives/edgar/data/9892/000119312511044634/dex10bw.htm)] | | | | | | 2005 Directors’ Stock Award Plan of C. R. Bard, Inc. (as Amended and Restated).* | | | | | | Incorporated by reference to Exhibit 10bw to the C.R. Bard, Inc. Annual Report on Form 10-K for the fiscal year ended December 31, 2010. | | |
| [removed: [10(n)](https://www.sec.gov/Archives/edgar/data/10795/000001079521000091/a09-30x2021ex10n.htm)] [added: [10(p)](https://www.sec.gov/Archives/edgar/data/10795/000162828022030686/advisoryboardconsultingagr.htm)] | | | | | | [removed: Letter] [added: Advisory Board Consulting] Agreement, dated [removed: August 4, 2021,] [added: October 31, 2022, by and] between the registrant and [removed: Christopher DelOrefice.*] [added: Claire M. Fraser.*] | | | | | | Filed with this report. | | |
| [4(](https://www.sec.gov/Archives/edgar/data/10795/000114036119009390/nt10001947x1_ex4-7.htm)[w](https://www.sec.gov/Archives/edgar/data/10795/000114036119009390/nt10001947x1_ex4-7.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000114036119009390/nt10001947x1_ex4-7.htm) | | | | | | Indenture, dated as of May 17, 2019, among Becton Dickinson Euro Finance S.à r.l. (“Becton Finance”), as issuer, Becton, Dickinson and Company, as guarantor, and The Bank of New York Mellon Trust Company, N.A., as trustee. | | | | | | Incorporated by reference to Exhibit 4.7 to the registrant’s Post-Effective Amendment to the Registration Statement on Form S-3 filed on May 17, 2019. | | |
| [10(c)](https://www.sec.gov/Archives/edgar/data/10795/000162828022030686/bdperformanceincentiveplan.htm) | | | | | | Performance Incentive Plan, as amended and restated August 30, 2022.* | | | | | | Filed with this report. | | |
| /S/ WILLIAM M. BROWN | | | | | | | | |
| William M. Brown | | | | | | Director | | |
| [4(](https://www.sec.gov/Archives/edgar/data/10795/000119312517383523/d517273dex41.htm)[s](https://www.sec.gov/Archives/edgar/data/10795/000119312517383523/d517273dex41.htm)[)](https://www.sec.gov/Archives/edgar/data/10795/000119312517383523/d517273dex41.htm) | | | | | | Registration Rights Agreement, dated as of December 29, 2017, between Becton, Dickinson and Company and Citigroup Global Markets Inc. | | | | | | Incorporated by reference to Exhibit 4.1 to the registrant's Current Report on Form 8-K filed on December 29, 2017. | | |
| | | | | | | | | |
| /S/ DAVID F. MELCHER | | | | | | | | |
| David F. Melcher | | | | | | Director | | |
| /S/ CLAIRE POMEROY | | | | | | | | |
| Claire Pomeroy | | | | | | Director | | |
| /S/ REBECCA W. RIMEL | | | | | | | | |
| Rebecca W. Rimel | | | | | | Director | | |
An excerpt. Shown here: 40 of 49 rewritten, all 4 added and all 8 removed. The counts are complete. For every sentence, read Item 16. Form 10-K Summary in the FY2022 filing and the FY2021 filing.