Becton Dickinson & Co. (BDX) 10-K risk factor changes: FY2020 vs FY2019

The following describes some of the [removed: significant] [added: material] risks that could adversely affect BD’s business, financial condition, operating results or cash flows.

We have previously experienced delays in collecting government receivables in certain countries in Western Europe due to [added: economic conditions, and we may experience similar delays in the future in these and other countries or regions experiencing financial problems.]

Group purchasing organizations and integrated health delivery networks have also served to concentrate purchasing decisions for some customers, [removed: which has led to downward pricing pressure for medical device suppliers.]

Our sales depend, in part, on the extent to which healthcare providers and facilities are reimbursed by [added: government authorities (including Medicare, Medicaid and comparable foreign programs) and private insurers for the costs of our products.]

Cost volatility could adversely affect our [removed: operations.][added: operations.]

Breaches of our information [removed: technology] systems could have a material adverse effect on our operations.

We rely on information [removed: technology] systems to process, transmit, and store electronic information in our day-to-day operations, including sensitive personal [removed: information and proprietary] or [removed: confidential] [added: proprietary] information.

In addition, some of our products include information [removed: technology] [added: systems] that collects data regarding patients and patient therapy on behalf of our customers and some connect to our systems for maintenance purposes.

Our information [removed: technology] systems have been subjected to attack via malicious code execution, and cyber- or phishing- attacks, and we have experienced instances of unauthorized access to our systems in the past and expect to be subject to similar [removed: attacks] [added: cyberattacks] in the future.

In addition to our own information, in the course of doing business, we sometimes store information with third parties that could be subject to [removed: these types of] attacks.

[removed: Cyber-attacks] [added: Cyberattacks] could result in our intellectual property and other confidential information being [removed: accessed] [added: accessed, destroyed] or stolen, which could adversely affect our competitive position in the market.

[removed: Cyber-attacks] [added: Cyberattacks] could result in unauthorized access to our systems and products which could also impact our compliance with privacy and other laws and regulations, and result in actions by regulatory bodies or civil litigation.

[added: While we will continue to dedicate significant resources to] protect against unauthorized access to our systems and products, and work with government authorities and third party providers to detect and reduce the risk of future cyber incidents, [removed: cyber-attacks] [added: cyberattacks] are becoming more sophisticated, frequent and adaptive.

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 United States and abroad, manufacture products in a cost-effective manner, obtain appropriate intellectual property [removed: protection for our products,] [added: protection,] and gain and maintain market acceptance of our products.

[removed: Our foreign operations subject us to certain risks relating to, among other things, fluctuations in foreign currency exchange (discussed above), local economic and political conditions, 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.

The [removed: June 2016 referendum in the] United [removed: Kingdom] [added: Kingdom’s] (“UK”) [removed: to exit] [added: departure from] the European Union (“EU”) (commonly known as “Brexit”) has created uncertainties affecting business operations in the [removed: UK and] [added: UK,] the [removed: EU,] [added: EU] and [removed: possibly] [added: a number of] other countries, including with respect to compliance with the regulatory regimes regarding the labeling and registration of the products we sell in these markets.

While we have taken proactive steps to mitigate any disruption to our operations, we could face increased [removed: regulatory] costs, volatility in exchange rates, market instability and other risks, depending on the [removed: final terms] [added: outcome] of the [removed: U.K.’s exit from] [added: negotiations regarding] the [removed: EU.][added: future EU/UK trading relationship.]

[added: To the extent we or third-parties are unable to sterilize our products, whether due to] lack of capacity, regulatory requirements or otherwise, we may be unable to transition sterilization to other sites or modalities in a timely or cost effective manner, or at all, which could have an adverse impact on our operating results.

We are or have been a defendant in a number of lawsuits, including, among others, purported class action lawsuits for alleged antitrust [removed: violations,] [added: violations and violations of federal securities laws,] product liability claims (which may involve lawsuits seeking class action status or seeking to establish multi-district litigation proceedings, including claims relating to our hernia repair implant products, surgical continence and pelvic organ prolapse products for women and vena cava filter products), and suits alleging patent infringement.

We have also been subject to government subpoenas [added: and civil investigative demands] seeking information with respect to alleged violations of law, including in connection with federal and/or state healthcare programs (such as Medicare or [removed: Medicaid)] [added: Medicaid), federal contracting requirements] and/or sales and marketing [removed: practices (such as the civil investigative demands).][added: practices.]

Our operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), export control, [added: product safety and efficacy,] employment, privacy and other areas.

We are [removed: also] subject to extensive regulation by the FDA pursuant to the Federal Food, Drug and Cosmetic Act, by comparable agencies in foreign countries, and by other regulatory agencies and governing bodies.

[added: Governmental] agencies may also impose new requirements regarding registration, labeling or prohibited materials that require us to modify or re-register products already on the market or otherwise impact our ability to market our products in those countries.

Our failure to comply with the applicable good manufacturing practices, adverse event reporting, and other requirements of these agencies could delay or prevent the production, marketing or sale of our products and result in [removed: fines,] delays or suspensions of regulatory clearances, warning letters or consent decrees, closure of manufacturing sites, import bans, seizures or recalls of [removed: products] [added: products, civil or criminal sanctions] and damage to our reputation.

In addition, the European Union (“EU”) has adopted the EU Medical Device Regulation (the “EU MDR”) and the In Vitro Diagnostic Regulation (the “EU IVDR”), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical [removed: evaluation] [added: evidence] requirements, quality systems and post-market surveillance.

Manufacturers of currently approved medical devices will have until May [removed: 2020] [added: 2021] to meet the requirements of the EU MDR [added: for self-certified devices] and until May [removed: 2022 to meet the EU IVDR.][added: 2024 for medical devices with a valid conformity assessment certificate.]

Failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to EU [added: conformity] requirements.

Our ability to compete effectively depends upon our ability to attract and retain executives and other key [removed: employees, including people in technical, marketing, sales and research positions.][added: employees.]

Competition for experienced employees, particularly for persons with specialized skills, can be [removed: intense.]

We [removed: have] substantially increased our indebtedness in connection with the Bard [removed: acquisition through the incurrence of new indebtedness to finance the acquisition and the assumption of Bard’s existing indebtedness,] [added: acquisition,] in comparison to our indebtedness on a [removed: recent] historical basis.

Moreover, in the future we may be required to raise substantial additional financing to fund [removed: working capital, capital expenditures,] the repayment or refinancing of our indebtedness, [removed: acquisitions] [added: acquisitions,] or [added: working capital, capital expenditures or] other general corporate requirements.

Business, Economic and Industry Risks

We are subject to risks associated with public health threats, including the ongoing COVID-19 pandemic, which has had, and we expect will continue to have, a material adverse effect on our business.

The nature and extent of future impacts are highly uncertain and unpredictable.

We are subject to risks associated with public health threats, including the COVID-19 pandemic.

The outbreak of COVID-19 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.

As a result, we experienced significant reductions in the demand for certain of our products, resulting from reductions in elective and non-essential procedures, lower utilization of routine testing and related specimen collection, reduced capital spend by customers and a decrease in research activity due to laboratory closures and reduced clinical testing.

While the United States and other countries have begun to reopen their economies, utilization rates for many of our products have not returned to pre-pandemic levels.

There may also be continued pressure on our margins due to manufacturing variances resulting from lower demand for certain of our products.

In addition, in response to the 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 the timing and availability of any COVID-19 vaccine and the entry of additional competitive products, that could impact the level of demand and pricing for our COVID-19 diagnostics testing.

Moreover, any resurgence in COVID-19 infections could result in the imposition of new governmental lockdowns, quarantine requirements or other restrictions to slow the spread of the virus, which could weaken demand for certain of our products, as discussed above.

Such measures have begun to be implemented again in certain European countries and in the United States as infections have begun to increase again, in some cases

significantly.

These measures could include determinations that our or our suppliers’ facilities are not essential businesses that could result in closures or other restrictions that significantly disrupt our operations or those of distributors or suppliers in our supply chain.

In addition, while we undertook certain financing activities as a precautionary measure during this economic slowdown, no assurance can be given that we will be able to access capital markets in the future without incurring significant costs and expense.

The scope and duration of the pandemic, including the current resurgences in various regions around the world and other future resurgences, the pace at which government restrictions are lifted or whether additional actions may be taken to contain the virus, the speed and extent to which global markets and utilization rates for our products fully recover from the disruptions caused by the pandemic, and the impact of these factors on our business, will depend on future developments that are highly uncertain and cannot be predicted with confidence.

To the extent COVID-19 adversely affects our operations and global economic conditions more generally, it may also have the effect of heightening many of the other risks described herein.

which has led to downward pricing pressure for medical device suppliers.

Our foreign operations subject us to certain risks relating to, among other things, fluctuations in foreign currency exchange (discussed above), local economic and political conditions, competition from local companies, increases in trade

The UK formally left the EU on January 31, 2020.

Pursuant to the withdrawal arrangement agreed between the UK and the EU, there is a transition period through December 31, 2020 for the parties to negotiate their future trading relationship.

During this transition period, the UK continues to follow the EU’s rules and its trading relationship with the EU remains the same.

intense.

Operational Risks

Legal, Quality and Regulatory Risks

As previously disclosed, we are undertaking certain remediation of our BD Alaris System, and are currently shipping the product in the U.S. only in cases of medical necessity.

We will not be able to fully resume commercial operations for the BD Alaris System in the U.S. until a 510(k) submission relating to the product has been filed with and subsequently cleared by the FDA.

No assurance can be given as to the time it may take for us to obtain FDA clearance of the 510(k).

Manufacturers of in vitro diagnostic devices have until May 2022 to meet the EU IVDR.

Privacy regulations are evolving rapidly and we expect to continue to see regional privacy laws emerge, similar to the GDPR and laws adopted in California, that may impact BD businesses to the extent they rely on the use of personal data.

Risks Relating to Our Indebtedness

General Business Risks

economic conditions, and we may experience similar delays in the future in these and other countries or regions experiencing financial problems.

government authorities (including Medicare, Medicaid and comparable foreign programs) and private insurers for the costs of our products.

The reinstatement of the PPACA's medical device tax may adversely affect our results of operations.

The PPACA imposes on medical device manufacturers, such as BD, a 2.3% excise tax on U.S. sales of certain medical devices.

While the excise tax has been suspended until the end of 2019, absent further legislative action, it will be reinstated in 2020, which would adversely affect our results of operation.

While we will continue to dedicate significant resources to

The possibility that the U.K. may exit the EU without a formal withdrawal agreement in place has increased the uncertainty around Brexit.

To the extent we or third-parties are unable to sterilize our products, whether due to

Governmental

In March 2019, the FDA issued a letter to healthcare professionals regarding the use of paclitaxel-coated devices in the treatment of peripheral artery disease, advising clinicians to consider using alternative treatments.

The FDA letter resulted in decreased sales of BD’s drug-coated balloons in fiscal year 2019 compared to the prior year.

The extent and duration of the impact from the FDA letter beyond fiscal year 2019, and the likelihood of FDA approval of new drug-coated devices, is difficult to predict, and no assurance can be given that it will not have a material impact on our results of operations in future periods.

We may not realize all of the anticipated benefits and cost savings resulting from our acquisition of Bard.

While we have realized significant cost savings to date in connection with our acquisition of Bard, achieving additional cost synergies may prove more difficult than expected, and it is possible that the anticipated cost synergies of the merger may not be realized fully, or may take longer to realize than expected.

We organize our operations outside the United States as follows: [removed: Europe;] [added: Europe,] EMA (which includes the Commonwealth of Independent States, the Middle East and Africa); Greater Asia (which includes countries in [removed: East Asia,] [added: Greater China, Japan,] South Asia, Southeast [removed: Asia] [added: Asia, Korea,] and [removed: the Oceania region);] [added: Australia and New Zealand);] Latin America (which includes Mexico, Central America, the [removed: Caribbean,] [added: Caribbean] and South America); and Canada.

BD remains focused on delivering [removed: sustainable] [added: durable] growth and [added: creating] shareholder value, while making appropriate investments for the future.

[removed: | • | To increase revenue growth by focusing] [added: - Focusing] on our core products, services and solutions that deliver greater benefits to patients, healthcare workers and researchers; [removed: |]

[removed: | • | To supplement] [added: - Supplementing] our internal growth through strategic acquisitions; [removed: |]

[removed: | • | To] [added: - Focusing on cash and expense management in order to] improve operating effectiveness and balance sheet [removed: productivity; |][added: productivity.]

[removed: | • | To drive] [added: - Driving] an efficient capital structure and strong shareholder returns. [removed: |]

In assessing the outcomes of these strategies as well as BD’s financial condition and operating performance, management generally reviews quarterly forecast data, monthly actual results, segment sales and [added: other similar information.]

Worldwide revenues in [removed: 2019] [added: 2020] of [removed: $17.290] [added: $17.117] billion [removed: increased 8.2%] [added: decreased 1.0%] from the prior-year period.

The [removed: increase reflected a favorable impact of approximately 6% resulting from] [added: Medical segment's revenues in 2019 were favorably impacted by] the inclusion of revenues [removed: from our acquisition of Bard] [added: associated with certain C.R. Bard, Inc. ("Bard") products within the Medication Delivery Solutions unit] in the first quarter of fiscal year 2019 but not in the first quarter of the prior-year period as operating activities of [removed: the business,] [added: Bard,] which was acquired on December 29, 2017, were not included in our consolidated results of operations until January 1, 2018.

[removed: | • |] [added: - The] Medical [removed: segment growth was driven by sales growth] [added: segment’s revenues] in [removed: all of the segment's units, particularly by growth] [added: 2020 reflected declines] in the Medication [removed: Management] [added: Delivery] Solutions, Medication [removed: Delivery] [added: Management] Solutions and [added: Diabetes Care units that were partially offset by growth in the] Pharmaceutical Systems [removed: units. |][added: unit.]

[removed: Our] [added: As noted above, our] financial position remains strong, with cash flows from operating activities totaling [removed: $3.330] [added: $3.539] billion in [removed: 2019.][added: 2020.]

At September 30, [removed: 2019,] [added: 2020,] we had [removed: $620 million] [added: $2.937 billion] in cash and equivalents and short-term investments, including restricted cash.

We continued to return value to our shareholders in the form of [removed: dividends.]

During fiscal year [removed: 2019,] [added: 2020,] we paid cash dividends of [removed: $984 million,] [added: $1.026 billion,] including [removed: $832] [added: $888] million paid to common shareholders and [removed: $152] [added: $137] million paid to preferred shareholders.

A stronger U.S. dollar in [removed: 2019,] [added: 2020,] compared with [removed: 2018,] [added: 2019,] resulted in an unfavorable foreign currency translation impact to our revenues and earnings during [removed: 2019.][added: 2020.]

Results on a foreign currency-neutral basis, as we present them, may not be comparable to similarly titled [added: measures used by other companies and are not measures of performance presented in accordance with U.S. GAAP.]

| | | | | | | | | | | | | | [removed: 2019] [added: | | | | | | | | 2020] vs. [removed: 2018] [added: 2019] | | | | | | | | | [removed: 2018] [added: | | | | | | | | | 2019] vs. [removed: 2017] [added: 2018] | | | | | | | | [added: | | | | | | |]

| (Millions of dollars) | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: Total Change] | | [removed: Total Change] | | | [removed: Estimated FX Impact] | [added: Estimated FX Impact] | | [added: | | | |] FXN Change | | | [removed: Total Change] | | | [removed: Estimated FX Impact] [added: Total Change] | | | [added: | | | Estimated FX Impact | | | | | |] FXN Change | | [added: |]

| Diabetes Care | [added: | | 1,084 | | | | | |] 1,110 | | | | [added: | |] 1,105 | | | | [removed: 1,056] | | [added: (2.4)] | | [removed: 0.5] [added: %] | [added: | | | (1.4) | |] % | | [removed: (2.4] | [removed: )%] | [added: (1.0)] | [removed: 2.9] | % | | [removed: 4.6] | [added: | 0.5 | |] % | | [removed: 1.7] | [added: | (2.4) | |] % | | [added: | |] 2.9 | [added: |] % |

| Pharmaceutical Systems | [added: | | 1,588 | | | | | |] 1,465 | | | | [removed: 1,397] | | [added: 1,397] | | [removed: 1,256] | | | | [removed: 4.8] [added: 8.4] | [added: |] % | | [removed: (3.4] | [removed: )%] | [added: (1.0)] | [removed: 8.2] | % | | [removed: 11.2] | [added: | 9.4 | |] % | | [added: | |] 4.8 | [added: |] % | | [removed: 6.4] | [added: | (3.4) | |] % | [added: | | | 8.2 | | % |]

| Total Medical revenues | [added: | |] $ | [added: 8,680 | | | | | $ |] 9,064 | | | [added: | |] $ | 8,616 | | | [removed: $] | [removed: 7,419] | [added: (4.2)] | | [removed: 5.2] [added: %] | [added: | | | (1.0) | |] % | | [removed: (2.3] | [removed: )%] | [added: (3.2)] | [removed: 7.5] | % | | [removed: 16.1] | [added: | 5.2 | |] % | | [removed: 2.1] | [added: | (2.3) | |] % | | [removed: 14.0] | [added: | 7.5 | |] % |

The [removed: Medical segment's revenues in 2019 were favorably impacted by the inclusion of revenues associated with certain Bard products within the] Medication Delivery [removed: Solutions unit in the first quarter of fiscal year 2019, as noted above, and] [added: Solution unit's 2019 revenues] also reflected strong growth in [removed: this unit's] global sales of vascular access devices.

| (Millions of dollars) | [removed: 2019] | | [added: 2020] | | [removed: 2018] | | | | [removed: 2017] [added: 2019] | | | [added: | | | 2018 | | |]

| Medical segment operating income [removed: (a)] | [added: | |] $ | [removed: 2,824] [added: 2,274] | | | [added: | |] $ | [removed: 2,624] [added: 2,824] | | | [added: | |] $ | [removed: 1,907] [added: 2,624] | |

| *Segment operating income as % of Medical revenues* | [removed: *31.2*] | | [added: *26.2* | |] *%* | | [removed: *30.5*] | | [added: *31.2* | |] *%* | | [removed: *25.7*] | | [added: *30.5* | |] *%* |

[removed: The] [added: As discussed in greater detail below, the] Medical segment's operating income [added: in 2020] was [added: primarily] driven by [removed: improved] [added: a decline in] gross profit [removed: margin and operating expense performance in 2019 and 2018 as discussed in greater detail below:][added: margin.]

[removed: -] The Medical segment's gross profit margin in 2019 was higher as compared with 2018 primarily due to lower manufacturing costs resulting from continuous improvement projects which enhanced the efficiency of our operations.

These unfavorable impacts [removed: to the Medical segment's gross margin] were partially offset by lower manufacturing costs resulting from continuous improvement projects which enhanced the efficiency of our [removed: operations and favorable product mix impact relating to the Bard products reported within the segment.][added: operations.]

[removed: -] Selling and administrative expense as a percentage of revenues in 2019 was relatively flat compared with 2018.

Selling and administrative expense as a percentage of [added: Life Sciences] revenues in [removed: 2018] [added: 2019] was lower compared [removed: with 2017 which] [added: to 2018] primarily [removed: reflected a reduction in the] [added: due to reduced] general and administrative [removed: costs allocated to the segment, as noted above.][added: spending.]

[removed: -] Research and development expense as a percentage of revenues was lower in 2019 [added: compared with 2018] due to recent completion of projects and the timing of project spending.

[added: -] Research and development expense as a percentage of revenues [removed: in 2018] was higher [removed: compared with 2017] [added: in 2020] which reflected [removed: increased investment] [added: the decline] in [added: revenues in 2020, as well as our continued commitment to drive innovation with] new products and platforms.

| | | | | | | | | | | | | | [removed: 2019] [added: | | | | | | | | 2020] vs. [removed: 2018] [added: 2019] | | | | | | | | | [removed: 2018] [added: | | | | | | | | | 2019] vs. [removed: 2017] [added: 2018] | | | | | | | | [added: | | | | | | |]

| (Millions of dollars) | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: Total Change] | | [removed: Total Change] | | | [removed: Estimated FX Impact] | [added: Estimated FX Impact] | | [added: | | | |] FXN Change | | | [removed: Total Change] | | | [removed: Estimated FX Impact] [added: Total Change] | | | [added: | | | Estimated FX Impact | | | | | |] FXN Change | | [added: |]

| Preanalytical Systems | [added: | |] $ | [added: 1,487 | | | | | $ |] 1,558 | | | [added: | |] $ | 1,553 | | | [removed: $] | [removed: 1,471] | [added: (4.6)] | | [removed: 0.3] [added: %] | [added: | | | (1.5) | |] % | | [removed: (3.0] | [removed: )%] | [added: (3.1)] | [removed: 3.3] | % | | [removed: 5.5] | [added: | 0.3 | |] % | | [removed: 1.4] | [added: | (3.0) | |] % | | [removed: 4.1] | [added: | 3.3 | |] % |

| Diagnostic Systems | [added: | | $ | 2,045 | | | | | $ |] 1,547 | | | | [added: | $ |] 1,536 | | | | [removed: 1,378] | [added: 32.1] | | [added: %] | [removed: 0.7] | [added: | | (1.3) | |] % | | [removed: (2.6] | [removed: )%] | [added: 33.4] | [removed: 3.3] | % | | [removed: 11.5] | [added: | 0.7 | |] % | | [removed: 1.9] | [added: | (2.6) | |] % | | [removed: 9.6] | [added: | 3.3 | |] % |

| Biosciences | [added: | | $ | 1,143 | | | | | $ |] 1,194 | | | | [added: | $ |] 1,241 | | | | [removed: 1,139] | [added: (4.3)] | | [added: %] | [removed: (3.8] | [removed: )%] | | [removed: (2.2] [added: (0.8)] | [removed: )%] | [added: %] | [removed: (1.6] | [removed: )%] | | [removed: 9.0] [added: (3.5)] | [added: |] % | | [removed: 2.2] | [added: | (3.8) | |] % | | [removed: 6.8] | [added: | (2.2) | |] % | [added: | | | (1.6) | | % |]

| Total Life Sciences revenues | [added: | |] $ | [added: 4,675 | | | | | $ |] 4,300 | | | [added: | |] $ | 4,330 | | | [removed: $] | [removed: 3,988] | [added: 8.7] | | [removed: (0.7] [added: %] | [removed: )%] | | [removed: (2.6] | [removed: )%] [added: (1.2)] | | [removed: 1.9] [added: %] | [added: | | | 9.9 | |] % | | [removed: 8.6] | [added: | (0.7) | |] % | | [removed: 1.8] | [added: | (2.6) | |] % | | [removed: 6.8] | [added: | 1.9 | |] % |

The Diagnostic Systems unit's 2019 revenues reflected growth in its [removed: *BD MAX*TM] [added: BD MAXTM] molecular platform as well as growth in sales of core microbiology products.

Revenues in the Biosciences unit in 2019 reflected growth in research reagent sales, as well as growth in U.S. research instrument sales, but were unfavorably impacted by the [added: unit's] divestiture of the Advanced Bioprocessing [removed: business, as previously discussed.][added: business.]

BD 2025, our current phase of value creation, is anchored in three key pillars: grow, simplify and empower.

BD's management team aligns our operations and investments with these key strategic pillars through continuous focus on the following underlying objectives:

Grow

- Developing and maintaining a strong portfolio of leading products and solutions that address significant unmet clinical needs, improve outcomes, and reduce costs;

- Investing in research and development that will result in category innovation and a robust product pipeline;

- Leveraging our global scale to expand our reach in providing access to affordable medical technologies around the world, including emerging markets;

Simplify

- Working across our supply chain to minimize environmental impacts;

- Creating more resilient operations based on an enterprise-wide renewable energy strategy;

- Reducing complexity across our manufacturing network and rationalizing our product portfolio;

- Enhancing our quality and risk management systems;

- Simplifying our internal business processes;

Empower

- Fostering a purpose-driven culture with a focus on positive impact to all stakeholders–customers, patients, employees and communities;

- Improving our ability to serve customers and enhance customer experiences through the digitalization of internal processes and go-to-market approaches;

- Cultivating an inclusive work environment that welcomes and celebrates diverse talent and perspectives.

COVID-19 Pandemic Impacts and Response

A novel strain of coronavirus disease (“COVID-19”) was officially declared a pandemic by the World Health Organization (“WHO”) in March 2020.

In efforts to slow and control the spread of COVID-19, governments around the world issued stay at home orders, travel restrictions as well as recommendations or mandates to avoid large gatherings or to self-quarantine.

Many governments also instituted restrictions on certain businesses and their activities, particularly those that were deemed non-essential.

These various measures led to a sudden and significant decline in economic activity within a number of countries worldwide.

Although the global economy has shown signs of recovery, current economic data indicates that full recovery has stalled in some major economies.

As further discussed below, disruptions resulting from the ongoing COVID-19 pandemic unfavorably impacted our results of operations in fiscal year 2020.

While certain of our organizational units realized positive benefits to revenues from the pandemic, total consolidated revenues in 2020 were unfavorably impacted by an estimated net $600 million.

Our financial position has remained strong and we continue to generate operating cash flows that are sufficient to meet our short-term liquidity needs.

We also further secured our financial flexibility during the economic downturn by increasing the commitments available under our revolving credit facility by $381 million and issuing $3.0 billion of equity securities.

Our fiscal year 2020 debt and equity transactions are further discussed in Notes 3 and 16 to the consolidated financial statements contained in Item 8.

We believe that given our debt ratings and our capital allocation strategy, we would have access to additional short-term and long-term capital should the need arise.

We have not observed any impairments of our assets due to the COVID-19 pandemic and its adverse impact on global economic activity in 2020.

As noted above, due to government restrictions and a shift in healthcare priorities, there was a significant decline in medical procedures that resulted in weakened demand for our products in our fiscal year 2020.

A decline in procedure volumes across acute and non-acute settings led to a decline in demand for general medical devices.

We also saw a deferral in elective procedures and delays in instrument placements relating to our medication management solutions, including Pyxis™.

There was also a decrease in routine diagnostic testing and specimen collections, which was offset by demand for COVID-19 testing.

Additionally, there was a decrease in research activity due to laboratory closures, delays in clinical trial enrollment and reduced clinical testing.

During the last half of our fiscal year 2020, we noted moderate recovery in the demand for certain products, including those products that are driven by the volume of elective procedures.

However, demand for our products has not yet fully recovered and due to the continued, significant uncertainty that exists relative to the duration and overall impact of the COVID-19 pandemic, our future operating performance, particularly in the short-term, will be subject to volatility.

The ultimate impact of the COVID-19 pandemic on our business, results of operations, financial condition and cash flows is dependent on future developments, which are uncertain at this time, including:

- The preparedness and effectiveness of countries around the world in preventing or responding to the ongoing spread of COVID-19, or in countries where the spread has been controlled, any resurgence of the virus;

- The degree to which COVID-19 testing solutions continue to be made available and are utilized by governments, healthcare providers and institutions, retail pharmacies and the general public;

- The pace at which hospitals and clinical laboratories fully resume patient care that is not related to the COVID-19 pandemic;

BD management operates the business consistent with the following core strategies:

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| • | To continue investment in research and development for platform extensions and innovative new products; |

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| • | To make investments in growing our operations in emerging markets; |

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| --- | --- |

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| --- | --- |

Our strategy focuses on four specific areas within healthcare and life sciences:

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| --- | --- |

| • | Enabling safer, simpler and more effective parenteral drug delivery; |

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| --- | --- |

| • | Improving clinical outcomes through new, more accurate and faster diagnostics; |

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| --- | --- |

| • | Providing tools and technologies to the research community that facilitate the understanding of the cell, cellular diagnostics, cell therapy and immunology; |

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| --- | --- |

| • | Enhancing disease management with our product offerings. |

We continue to strive to improve the efficiency of our capital structure and follow these guiding principles:

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| --- | --- |

| • | To operate the Company consistent with an investment grade credit profile; |

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| --- | --- |

| • | To ensure access to the debt market for strategic opportunities; |

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| --- | --- |

| • | To optimize the cost of capital based on market conditions. |

other similar information.

Revenues in 2019 also reflected an unfavorable impact of almost 1% attributable to the Biosciences unit's divestiture of its Advanced Bioprocessing business at the end of October 2018, as is further discussed in Note 11 to the consolidated financial statements contained in Item 8.

Additionally, certain of Bard's product offerings are included within BD Medical as part of the Medication Delivery Solutions [removed: unit (formerly Medication and Procedural Solutions).][added: unit.]

BD Medical consists of the following [added: organizational units:]

| *Organizational Unit* | [added: | |] *Principal Product Lines* | [added: | |]

| Medication Delivery Solutions | [added: | |] Peripheral intravenous ("IV") catheters (conventional, safety); advanced peripheral catheters (guidewire assisted peripherally inserted venous catheters, midline catheters, port access); central lines (peripherally inserted central catheters); acute dialysis catheters; vascular access technology (ultrasonic imaging); vascular care (lock solutions, prefilled flush syringes, disinfecting caps); vascular preparation (skin antiseptics, dressings, securement); needle-free IV connectors and extensions sets; closed-system drug transfer devices; hazardous drug detection; conventional and safety hypodermic syringes and needles, anesthesia needles (spinal, epidural) and trays; enteral [removed: syringes,] [added: syringes; and] sharps disposal systems. | [added: | |]

| Medication Management Solutions | [added: | |] 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; and informatics and analytics solutions for enterprise medication management. | [added: | |]

| Diabetes Care | [added: | |] Syringes, pen needles and other products related to the injection or infusion of insulin and other drugs used in the treatment of diabetes. | [added: | |]

| Pharmaceutical Systems | [added: | |] Prefillable drug delivery systems - prefillable syringes, safety, shielding and self-injection systems and support services - provided to pharmaceutical companies for use as containers for injectable pharmaceutical products, which are then placed on the market as drug/device combinations. | [added: | |]

BD Life Sciences provides products for the safe collection and transport of diagnostics specimens, and instruments and reagent systems to detect a broad range of infectious diseases, healthcare-associated infections [removed: (“HAIs”)] and cancers.

| *Organizational Unit* | [added: | |] *Principal Product Lines* | [added: | |]

| [added: Integrated] Diagnostic [removed: Systems] [added: Solutions] | [removed: Automated] [added: | | Integrated systems for specimen collection; safety-engineered] blood [added: 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 for cervical cancer screening; rapid diagnostic assays for testing of respiratory infections; microbiology laboratory automation; and plated media for clinical and industrial applications. | [added: | |]

| Biosciences | [added: | |] Fluorescence-activated cell sorters and analyzers; antibodies and kits for performing cell analysis; reagent systems for life science research; solutions for high-throughput single-cell gene expression analysis; and clinical oncology, immunological (HIV) and transplantation diagnostic/monitoring reagents and analyzers. | [added: | |]

| *Organizational Unit* | [added: | |] *Principal Product Lines* | [added: | |]

| Surgery | [added: | |] Hernia and soft tissue repair, biological grafts, bioresorbable grafts, biosurgery, and other surgical products; BD ChloraPrep™ surgical infection prevention [removed: products,] [added: products;] and V. Mueller™ surgical and laparoscopic instrumentation products. | [added: | |]

| Peripheral Intervention | [added: | |] Percutaneous transluminal angioplasty (“PTA”) balloon catheters, peripheral vascular stents, self-expanding and balloon-expandable stent grafts, vascular grafts, drug coated balloons, ports, biopsy, chronic dialysis, feeding, [removed: IVC] [added: inferior vena catheter] filters, endovascular fistula creation devices and drainage [removed: products.] [added: products, and atherectomy and thrombectomy system.] | [added: | |]

| Urology and Critical Care | [added: | |] Urine management devices, urological drainage products, intermittent catheters, kidney stone management devices, Targeted Temperature Management, and fecal management devices. | [added: | |]

For reporting purposes, we organize our operations outside the United States as follows: Europe, EMA (which includes the Commonwealth of Independent States, the Middle East and Africa); Greater Asia (which includes countries in [removed: East Asia,] [added: Greater China, Japan,] South Asia, Southeast [removed: Asia] [added: Asia, Korea,] and [removed: the Oceania region);] [added: Australia and New Zealand);] Latin America (which includes Mexico, Central America, the Caribbean and South America); and Canada.

The principal products sold by BD outside the United States are hypodermic needles and syringes; insulin syringes and pen needles; BD Hypak™ brand prefillable syringe systems; infusion therapy products, including [added: BD] Alaris™ infusion pumps; pharmacy automation equipment, including Pyxis™ systems; devices and services for the treatment of peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance; synthetic and resorbable mesh, biologic implants and fixation systems to complement innovative techniques for inguinal, ventral and other hernia repair procedures; medical devices for urine drainage in the acute care hospital and home care settings; BD Vacutainer™ brand blood collection products; diagnostic systems and laboratory equipment and products; and flow cytometry instruments and reagents.

BD’s worldwide sales are not generally seasonal, with the exception of certain medical devices in the Medication Delivery Solutions business unit, and flu diagnostic products in the [added: Integrated] Diagnostic Systems business unit, which relate to seasonal diseases such as influenza.

Reimbursement [removed: remains] [added: is] an important strategic consideration in the development and marketing of medical technology.

[removed: Difficulty in obtaining] [added: Obtaining] coverage, coding and payment [removed: resulting in decreased market access can be a significant barrier] [added: is critical] to the commercial success of a new product or procedure.

[removed: The consequences] [added: Difficulty in achieving market access] can [removed: include] [added: lead to] slow adoption in the marketplace and inadequate payment levels that can continue for months or even years.

[added: Vertical integration has created a very concentrated market among commercial third-party payers in the U.S.] Global payers are increasingly focused on strategies to control spending on healthcare and reward improvements in quality and patient outcomes.

As government programs [removed: seek to] expand healthcare coverage for their citizens, they have at the same time sought to control costs by limiting the amount of reimbursement they will pay for particular procedures, products or services.

Many payers [added: both in the U.S. and globally] have developed specific payment and delivery mechanisms to support these cost control efforts and to focus on paying for value.

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.]

For example, as a result of the Patient Protection and Affordable Care Act (“PPACA”), the U.S. [removed: is implementing] [added: has implemented] value-based payment methodologies and [removed: seeking to create] [added: has created] alternative payment models such as bundled payments to continue to drive improved value.

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 resource based reimbursement becoming more common in regions outside the [removed: US.][added: U.S.]

BD's operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), export control, [added: product safety and efficacy,] employment, privacy and other areas.

These regulatory controls, as well as any changes in [removed: FDA] [added: agency] policies, can affect the time and cost associated with the development, introduction and continued availability of new [added: and existing] products.

This [removed: appears to be] [added: is] part of a general trend toward increased regulation and enforcement activity within and outside the United States.

Failure to comply with these [removed: provisions] [added: laws] could result in a range of fines, penalties and/or other sanctions.

CareFusion’s consent decree with the FDA [added: is] related to its Alaris™ SE infusion pumps.

In February 2009, CareFusion and the FDA amended the consent decree to include all infusion pumps manufactured by or for CareFusion 303, Inc., the organizational unit that manufactures and sells [added: BD Alaris] infusion pumps in the United States.

As of September 30, [removed: 2019,] [added: 2020,] we do not believe that a loss is probable in connection with the amended consent decree, and accordingly, we have no accruals associated with compliance with the amended consent decree.

On January 11, 2018, BD received a Warning Letter from the [removed: FDA,] [added: FDA with respect to our BD Preanalytical Systems ("PAS") unit,] citing certain alleged violations of quality system regulations and of law.

BD [removed: is working] [added: has worked] closely with the FDA and [removed: intends to fully implement] [added: implemented] corrective actions to address the concerns identified in the [removed: Warning Letter.][added: warning letter.]

Under the terms of the consent order, [added: which has been amended two times upon mutual agreement of] BD [added: and EPD, BD] voluntarily agreed to a number of operational changes at its Covington and Madison, Georgia facilities designed to further reduce ethylene oxide emissions, including but not limited to operating at a reduced capacity.

BD [removed: also] makes available its Annual Reports on Form 10-K, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K (and amendments to those reports) as soon as reasonably practicable after those reports are electronically filed with, or furnished to, the Securities and Exchange Commission (“SEC”).

[removed: Printed copies of these materials, this 2019 Annual Report on Form 10-K, and BD’s reports and statements filed with, or furnished to,] the SEC, may also be obtained, without charge, by contacting the Corporate Secretary, BD, 1 Becton Drive, Franklin Lakes, New Jersey 07417-1880, telephone 201-847-6800.

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C. R. Bard Acquisition

assessments.

Countries outside the United States have enacted similar local laws requiring medical device companies to report transfers of value to health care providers licensed in those countries.

We are undertaking certain remediation of our BD Alaris System, and are currently shipping the product in the U.S. only in cases of medical necessity.

We will not be able to fully resume commercial operations for the BD Alaris System in the U.S. until a 510(k) submission relating to the product has been filed with and subsequently 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 that contains a number of observations of non-conformance.

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.

In March 2020, the FDA conducted a subsequent inspection of PAS, which it classified as Voluntary Action Indicated, which means the FDA will not take or recommend any administrative or regulatory action as a result of the unit’s response to the observations in the inspection.

Human Capital Management

As of September 30, 2020, we had approximately 72,000 associates located in over 70 different countries in a variety of different roles.

We compete in the highly competitive medical technology industry.

Attracting, developing and retaining talented people in technical, marketing, sales, research and other positions is crucial to executing our strategy and our ability to compete effectively.

Our ability to recruit and retain such talent depends on a number of factors, including compensation and benefits, talent development and career opportunities, and work environment.

To that end, we invest in our associates in order to be an employer of choice.

Diversity & Inclusion

Our associates reflect the communities we live and work in, the customers and patients we serve, and possess a broad range of thought and experiences that have helped BD achieve our leadership position in the medical technology industry and the global marketplace.

A key component of our journey to continually build a better BD is our commitment to global inclusion and diversity ("I&D").

We believe this commitment allows us to better our understanding of patient and customer needs and develop technologies to meet those needs.

Our I&D efforts have garnered recognitions, including Best Places to Work for Disability and LGBTQ Inclusion, Bloomberg’s Gender Equality Index, and Diversity Inc’s Noteworthy Companies.

Although we have made progress in our workforce diversity representation, we seek to continuously improve in this area.

Each year, we establish annual corporate I&D goals to continue improving our hiring, development, advancement, and retention of diverse talent and our overall diversity representation.

In addition, our executive leaders serve as sponsors of our nine associate-led resource groups ("ARGs") in support of their efforts to provide meaningful professional development for our workforce, drive business improvement and innovation and contribute to BD's role as a socially responsible community member.

Externally, we are involved in industry I&D efforts as one of several companies taking a leadership role in AdvaMed’s efforts to improve diversity in the medical technology industry.

We have also committed to leadership in I&D through our support for the Equality Act and the United Nations’ Open for Business program and organizations like The Human Rights Campaign, Equal Justice Initiative, and The United Negro College Fund.

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 underrepresented communities.

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| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| BD 2020 Workforce Diversity Representation | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | |

| | | | Gender (Global) | | | Year-Over-Year Improvement | | | Race (U.S. Only) | | | Year-Over-Year Improvement | | |

| Executive | | | 28% | | | +3% | | | 20% | | | +2% | | |

| Management | | | 39% | | | — | | | 28% | | | +2% | | |

organizational units:

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| --- | --- |

| | |

| | |

| --- | --- |

| | |

| Preanalytical Systems | Integrated systems for specimen collection; and safety-engineered blood collection products and systems. |

Effective October 1, 2019, BD Life Sciences joined its Preanalytical Systems and Diagnostic Systems organizational units to create a new Integrated Diagnostic Solutions organizational unit which will focus on driving growth and innovation around integrated specimen management to diagnostic solutions.

The new Integrated Diagnostic Solutions organizational unit will consist of the following principal product lines:

| | |

| --- | --- |

| | |

| Integrated Diagnostic Solutions | Integrated systems for specimen collection; safety-engineered blood collection products and systems; automated blood culturing and tuberculosis culturing systems; molecular testing systems for infectious diseases and women’s health; microorganism identification and drug susceptibility systems; liquid-based cytology systems for cervical cancer screening; rapid diagnostic assays for testing of respiratory infections; microbiology laboratory automation; and plated media for clinical and industrial applications. |

| | |

| --- | --- |

| | |

| *Organizational Unit* | *Principal Product Lines* |

Acquisitions

*TVA Medical, Inc.*

In July 2018, BD acquired TVA Medical, Inc., a company that develops minimally invasive vascular access solutions for patients with chronic kidney disease requiring hemodialysis.

*C. R. Bard, Inc.*

Additional information regarding the Bard acquisition is contained in Note 10 to the consolidated financial statements contained in Item 8.

Financial Statements and Supplementary Data, which is incorporated herein by reference.

*CareFusion Corporation*

On March 17, 2015, BD completed the acquisition of CareFusion Corporation (“CareFusion”), a global medical technology company with a comprehensive portfolio of products in the areas of medication management, infection prevention, operating room and procedural effectiveness, and respiratory care.

*Remaining interest in Caesarea Medical Electronics*

Upon its acquisition of CareFusion, BD acquired a 40% ownership interest in Caesarea Medical Electronics ("CME"), an Israeli-based global infusion pump systems manufacturer.

On April 3, 2017, BD acquired the remaining 60% ownership interest in CME.

On October 3, 2016, BD sold a 50.1% controlling financial interest in its Respiratory Solutions business, a component of the Medical segment, to form a venture, Vyaire Medical.

BD retained a 49.9% non-controlling interest in the new standalone entity.

BD agreed to various contract manufacturing and certain logistical and transition services agreements with the new entity for a period of up to two years after the sale.

Vertical integration has created a very concentrated market among payers.

In May 2017, the FDA conducted inspections at BD’s Preanalytical Systems (“PAS”) facility in Franklin Lakes, New Jersey.

In July 2017, the FDA issued a Form 483 to BD PAS in connection with these inspections that contained observations of non-conformance relating to quality system regulations and medical device reporting relating to certain of our BD Vacutainer™ EDTA blood collection tubes.

We submitted our response to the Warning Letter on January 31, 2018.

However, BD cannot give any assurances that the FDA will be satisfied with its responses to the Warning Letter or as to the expected date of resolution of matters included in the Warning Letter.

While BD does not believe that the issues identified in the Warning Letter will have a material impact on BD’s operation, no assurances can be given that the resolution of this matter will not have a material adverse effect on BD’s business, results of operations, financial conditions and/or liquidity.

Employees

As of September 30, 2019, BD had 70,093 employees, of which 24,191 were employed in the U.S. (including Puerto Rico).

[removed: Form 10-K][added: Form 10-K]

[removed: ☑ANNUAL] [added: ☑ ANNUAL] REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year [removed: ended September] [added: ended September] 30, [removed: 2019][added: 2020]

[removed: ☐TRANSITION] [added: ☐ TRANSITION] REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

COMMISSION FILE [removed: NUMBER 001-4802][added: NUMBER: 001-4802]

| New Jersey | | | | [added: | | | | | | | |] 22-0760120 | [added: | |]

| *(State or other jurisdiction of incorporation or organization)* | | | | [added: | | | | | | | |] *(I.R.S. Employer Identification No.)* | [added: | |]

| 1 Becton Drive, | [added: | |] Franklin Lakes, | [added: | |] New Jersey | | [added: | | | |] 07417-1880 | [added: | |]

| *(Address of principal executive offices)* | | | | [added: | | | | | | | |] *(Zip code)* | [added: | |]

Registrant’s telephone number, including area code [removed: (201) 847-6800][added: (201) 847-6800]

| Title of Each Class | | [added: | | | |] Trading Symbol | | [added: | | | |] Name of Each Exchange on Which Registered | [added: | |]

| Common stock, par value $1.00 | | [added: | | | |] BDX | | [added: | | | |] New York Stock Exchange | [added: | |]

| Depositary Shares, each representing [added: a] 1/20th [removed: of] [added: interest in] a share of [removed: 6.125% Cumulative] [added: 6.00% Mandatory Convertible] Preferred [removed: Stock] [added: Stock,] Series [removed: A] [added: B] | | [removed: BDXA] | | [added: | | BDXB | | | | | |] New York Stock Exchange | [added: | |]

| 1.000% Notes due December 15, 2022 | | [added: | | | |] BDX22A | | [added: | | | |] New York Stock Exchange | [added: | |]

| 1.900% Notes due December 15, 2026 | | [added: | | | |] BDX26 | | [added: | | | |] New York Stock Exchange | [added: | |]

| 1.401% Notes due May 24, 2023 | | [added: | | | |] BDX23A | | [added: | | | |] New York Stock Exchange | [added: | |]

| 3.020% Notes due May 24, 2025 | | [added: | | | |] BDX25 | | [added: | | | |] New York Stock Exchange | [added: | |]

| 0.174% Notes due June 4, 2021 | | [added: | | | |] BDX/21 | | [added: | | | |] New York Stock Exchange | [added: | |]

| 0.632% Notes due June 4, 2023 | | [added: | | | |] BDX/23A | | [added: | | | |] New York Stock Exchange | [added: | |]

| 1.208% Notes due June 4, 2026 | | [added: | | | |] BDX/26A | | [added: | | | |] New York Stock Exchange | [added: | |]

Indicate by check mark whether the registrant is a "large accelerated filer," an "accelerated filer," a "non-accelerated filer," "smaller reporting company," or an "emerging growth company." [removed: See the definitions of large accelerated filer, accelerated filer, smaller reporting company, and emerging growth company in Rule 12b-2 of the Exchange Act.]

| Large accelerated filer | | [added: | | | |] ☑ | | [added: | | | |] Accelerated filer | | [added: | | | |] ☐ | | [added: | | | |] Non-accelerated filer | | [added: | | | |] ☐ | [added: | |]

| Smaller reporting company | | [added: | | | |] ☐ | | [added: | | | |] Emerging growth company | | [added: | | | |] ☐ | | | | | [added: | | | | | | | | | |]

| If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | |] ☐ | [added: | |]

As of March 31, [removed: 2019,] [added: 2020,] the aggregate market value of the registrant’s outstanding common stock held by non-affiliates of the registrant was approximately [removed: $67,278,853,280.][added: $62,360,106,701.]

As of October 31, [removed: 2019, 270,459,892] [added: 2020, 290,031,363] shares of the registrant’s common stock were outstanding.

Documents Incorporated by Reference Portions of the registrant’s Proxy Statement for the Annual Meeting of Shareholders to be held January [removed: 28, 2020] [added: 26, 2021] are incorporated by reference into Part III hereof.

| [Item 1. [removed: Business](#sD6D31602FC3F510584952B8152C103EA)] [added: Business](#iaa48bd2797b246e8b2d49fcf1f902a81_16)] | [removed: [1](#sD6D31602FC3F510584952B8152C103EA)] | [added: | [1](#iaa48bd2797b246e8b2d49fcf1f902a81_16) | | |]

| [Item 1A. Risk [removed: Factors](#sF93263AA516054E9BB1DBA741BC719B1)] [added: Factors](#iaa48bd2797b246e8b2d49fcf1f902a81_19)] | [removed: [10](#sF93263AA516054E9BB1DBA741BC719B1)] | [added: | [10](#iaa48bd2797b246e8b2d49fcf1f902a81_19) | | |]

| [Item 1B. Unresolved Staff [removed: Comments](#s0FF850BA8C0559D9AEFE83487D9C2869)] [added: Comments](#iaa48bd2797b246e8b2d49fcf1f902a81_22)] | [removed: [18](#s0FF850BA8C0559D9AEFE83487D9C2869)] | [added: | [19](#iaa48bd2797b246e8b2d49fcf1f902a81_22) | | |]

| [Item 2. [removed: Properties](#sC91322D3A679512D9E38D94A5A5E5834)] [added: Properties](#iaa48bd2797b246e8b2d49fcf1f902a81_25)] | [removed: [18](#sC91322D3A679512D9E38D94A5A5E5834)] | [added: | [19](#iaa48bd2797b246e8b2d49fcf1f902a81_25) | | |]

| [Item 3. Legal [removed: Proceedings](#sDDB20431A09258D48BBD24A1E620D608)] [added: Proceedings](#iaa48bd2797b246e8b2d49fcf1f902a81_28)] | [removed: [19](#sDDB20431A09258D48BBD24A1E620D608)] | [added: | [19](#iaa48bd2797b246e8b2d49fcf1f902a81_28) | | |]

| [Item 4. Mine Safety [removed: Disclosures](#s8913BF6F094F51D58805E094B7B76B04)] [added: Disclosures](#iaa48bd2797b246e8b2d49fcf1f902a81_31)] | [removed: [19](#s8913BF6F094F51D58805E094B7B76B04)] | [added: | [19](#iaa48bd2797b246e8b2d49fcf1f902a81_31) | | |]

| [Information About Our Executive [removed: Officers](#s2DB28D2AD1FC55C386B9C6C0D4AE43BA)] [added: Officers](#iaa48bd2797b246e8b2d49fcf1f902a81_34)] | [removed: [20](#s2DB28D2AD1FC55C386B9C6C0D4AE43BA)] | [added: | [20](#iaa48bd2797b246e8b2d49fcf1f902a81_34) | | |]

| [Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#sD54D20C01B515821A76CFDF829929E3D)] [added: Securities](#iaa48bd2797b246e8b2d49fcf1f902a81_40)] | [removed: [21](#sD54D20C01B515821A76CFDF829929E3D)] | [added: | [21](#iaa48bd2797b246e8b2d49fcf1f902a81_40) | | |]

| [Item 6. Selected Financial [removed: Data](#sA14829ABEF585917AAB98D3FA85F83FB)] [added: Data](#iaa48bd2797b246e8b2d49fcf1f902a81_43)] | [removed: [22](#sA14829ABEF585917AAB98D3FA85F83FB)] | [added: | [22](#iaa48bd2797b246e8b2d49fcf1f902a81_43) | | |]

| [Item 7. Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#s58B5F14DE43B5F23AE6BDC3B4E2EFE83)] [added: Operations](#iaa48bd2797b246e8b2d49fcf1f902a81_46)] | [removed: [23](#s58B5F14DE43B5F23AE6BDC3B4E2EFE83)] | [added: | [23](#iaa48bd2797b246e8b2d49fcf1f902a81_46) | | |]

| [Item 7A. Quantitative and Qualitative Disclosures About Market [removed: Risk](#sFD77919F40E7565CAE37DCD3B8D7990B)] [added: Risk](#iaa48bd2797b246e8b2d49fcf1f902a81_49)] | [removed: [43](#sFD77919F40E7565CAE37DCD3B8D7990B)] | [added: | [45](#iaa48bd2797b246e8b2d49fcf1f902a81_49) | | |]

| [Item 8. Financial Statements and Supplementary [removed: Data](#s9D7CD619BF855CC69079146916FB7627)] [added: Data](#iaa48bd2797b246e8b2d49fcf1f902a81_52)] | [removed: [44](#s9D7CD619BF855CC69079146916FB7627)] | [added: | [46](#iaa48bd2797b246e8b2d49fcf1f902a81_52) | | |]

| [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial [removed: Disclosure](#s2CA13805A7925224A38DB0BBC3C9928E)] [added: Disclosure](#iaa48bd2797b246e8b2d49fcf1f902a81_172)] | [removed: [103](#s2CA13805A7925224A38DB0BBC3C9928E)] | [added: | [101](#iaa48bd2797b246e8b2d49fcf1f902a81_172) | | |]

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Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

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| [PART I](#iaa48bd2797b246e8b2d49fcf1f902a81_13) | | | [1](#iaa48bd2797b246e8b2d49fcf1f902a81_13) | | |

| [PART II](#iaa48bd2797b246e8b2d49fcf1f902a81_37) | | | [21](#iaa48bd2797b246e8b2d49fcf1f902a81_37) | | |

| [PART III](#iaa48bd2797b246e8b2d49fcf1f902a81_181) | | | [103](#iaa48bd2797b246e8b2d49fcf1f902a81_184) | | |

| [PART IV](#iaa48bd2797b246e8b2d49fcf1f902a81_199) | | | [104](#iaa48bd2797b246e8b2d49fcf1f902a81_199) | | |

| [Item 16. Form 10-K Summary](#iaa48bd2797b246e8b2d49fcf1f902a81_205) | | | [104](#iaa48bd2797b246e8b2d49fcf1f902a81_202) | | |

| [EXHIBIT INDEX](#iaa48bd2797b246e8b2d49fcf1f902a81_208) | | | [105](#iaa48bd2797b246e8b2d49fcf1f902a81_208) | | |

| [SIGNATURES](#iaa48bd2797b246e8b2d49fcf1f902a81_211) | | | [110](#iaa48bd2797b246e8b2d49fcf1f902a81_211) | | |

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| [PART I](#s332A9FAD352F5DB0AE713EEEC220E90F) | [1](#s332A9FAD352F5DB0AE713EEEC220E90F) |

| [PART II](#s6B8B6AC120145CE484EC394FACA4260E) | [21](#s6B8B6AC120145CE484EC394FACA4260E) |

| [PART III](#s4FE4D87A731D5A819E4362FE9CC06D22) | [104](#s4FE4D87A731D5A819E4362FE9CC06D22) |

| [PART IV](#s8421C5ADB54E5E53BDF01D81797864B1) | [105](#s8421C5ADB54E5E53BDF01D81797864B1) |

| [SIGNATURES](#s037B73CC75A6522881B2662CEE99B716) | [111](#s037B73CC75A6522881B2662CEE99B716) |

| [EXHIBIT INDEX](#sD5227AF16FE55BD5A2E247CCB2863466) | [106](#sD5227AF16FE55BD5A2E247CCB2863466) |

As of [removed: October 28, 2019,] [added: September 2020,] BD owned or leased [removed: 362] [added: 323] facilities throughout the world, comprising approximately [removed: 25,296,582] [added: 25,205,525] square feet of manufacturing, warehousing, administrative and research facilities.

The U.S. facilities, including those in Puerto Rico, comprise approximately [removed: 8,428,226] [added: 8,475,393] square feet of owned and [removed: 4,458,036] [added: 4,166,494] square feet of leased space.

[added: The international] facilities comprise approximately [removed: 8,971,758] [added: 9,582,786] square feet of owned and [removed: 3,438,562] [added: 2,980,824] square feet of leased space.

The U.S. facilities are located in Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Minnesota, Missouri, [removed: Montana,] Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, D.C., Washington, and Puerto Rico.

\- *Latin America*, which includes facilities in Argentina, Brazil, Chile, Colombia, [removed: Mexico, Peru and] the Dominican [removed: Republic.][added: Republic, Mexico and Peru.]

The international

| Name | [added: | |] Age | [added: | |] Position | [added: | |]

| Vincent A. Forlenza | [removed: 66] | [added: | 67 | | |] Chairman since July 2012; Chief Executive Officer [removed: since 2011;] [added: from October 2011 to January 2020;] and President from January 2009 to April 2017. [removed: Mr. Forlenza will become executive Chairman, effective January 28, 2020.] | [added: | |]

| Thomas E. Polen | [removed: 46] | [added: | 47 | | |] Chief [removed: Operating] [added: Executive] Officer since [removed: October 2018;] [added: January 2020;] President since April 2017; [added: Chief Operating Officer from October 2018 to January 2020;] and Executive Vice President and President - Medical Segment from October 2014 to April 2017. [removed: The BD Board of Directors has elected Mr. Polen to serve as BD's Chief Executive Officer and President, effective January 28, 2020.] | [added: | |]

| Simon D. Campion | [removed: 48] | [added: | 49 | | |] 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. | [added: | |]

| Alexandre Conroy | [removed: 56] | [added: | 57 | | |] 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. | [added: | |]

| Roland Goette | [removed: 57] | [added: | 58 | | |] Executive Vice President and President, EMEA since May 2017; and President, Europe from October 2014 to May 2017. | [added: | |]

| Patrick K. Kaltenbach | [removed: 56] | [added: | 57 | | |] Executive Vice President and President, Life Sciences Segment since May 2018; and Senior Vice President and President, Life Sciences and Applied Markets Group, Agilent Technologies, Inc. from November 2014 to April 2018. [added: As previously announced, Mr. Kaltenbach will be leaving BD in January 2021.] | [added: | |]

| Samrat S. Khichi | [removed: 52] | [added: | 53 | | |] Executive Vice President, Public Policy and Regulatory Affairs since May 2019; 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. | [added: | |]

| Betty D. Larson | [removed: 43] | [added: | 44 | | |] Executive Vice President, Human Resources, and Chief Human Resources Officer since July 2018; Senior Vice President of Human Resources, Interventional Segment from December 2017 to July 2018; [added: and] Vice President, Human Resources, C.R. Bard, Inc. from September [removed: 2017] [added: 2014] to December [removed: 2017; and prior thereto, Vice President, Human Resources - Global Medical Products Business, C.R. Bard, Inc.] [added: 2017.] | [added: | |]

| James Lim | [removed: 55] | [added: | 56 | | |] Executive Vice President and President, Greater Asia since June 2012. | [added: | |]

| Alberto Mas | [removed: 58] | [added: | 59 | | |] 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. | [added: | |]

| Christopher R. Reidy | [removed: 62] | [added: | 63 | | |] Executive Vice President, Chief Financial Officer and Chief Administrative Officer since July 2013. | [added: | |]

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| Antoine Ezell | | | 51 | | | President, North America since October 2020; Executive Vice President and Chief Marketing Officer since January 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. | | |

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As of October 31, [removed: 2019,] [added: 2020,] there were approximately [removed: 13,277] [added: 12,656] 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: 2019.][added: 2020.]

| Period | [added: | |] Total Number [removed: of Shares Purchased(1)] [added: of Shares Purchased(1)] | | | [removed: Average Price Paid per] [added: | | | Average Price Paid per] Share | | | [added: | | |] Total Number of [removed: Shares Purchased] [added: Shares Purchased] as Part [removed: of Publicly Announced Plans] [added: of Publicly Announced Plans] or Programs | | | [added: | | |] Maximum [removed: Number of] [added: Number of] Shares [removed: that May] [added: that May] Yet [removed: be Purchased] [added: be Purchased] Under [removed: the Plans] [added: the Plans] or Programs(2) | | [added: |]

| September 1-30, [removed: 2019] [added: 2020] | [added: | |] — | | | [added: | | |] — | | | [added: | | |] — | | | [added: | | |] 7,857,742 | | [added: |]

| Total | [removed: 1,541] | | [added: 1,258] | [removed: $252.66] | | | [added: | | $272.29 | | | | | |] — | | | [added: | | |] 7,857,742 | | [added: |]

[removed: | (1) | Includes] [added: (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. [removed: |]

[removed: | (2) | Represents] [added: (2)Represents] shares available under the repurchase program authorized by the Board of Directors on September 24, 2013 for 10 million shares, for which there is no expiration date. [removed: |]

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| July 1-31, 2020 | | | 1,144 | | | | | | $273.36 | | | | | | — | | | | | | 7,857,742 | | |

| August 1-31, 2020 | | | 114 | | | | | | $261.53 | | | | | | — | | | | | | 7,857,742 | | |

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| July 1-31, 2019 | 1,329 | | | $253.11 | | | — | | | 7,857,742 | |

| August 1-31, 2019 | 212 | | | $249.88 | | | — | | | 7,857,742 | |

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| | [added: | |] Years Ended September 30 | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: 2017] | | [removed: 2016] | | | | [removed: 2015] [added: 2016] | | |

| | [added: | |] Dollars in millions, except share and per share amounts | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| Operations | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| Revenues | [added: | |] $ | [removed: 17,290] [added: 17,117] | | | [added: | |] $ | [removed: 15,983] [added: 17,290] | | | [added: | |] $ | [removed: 12,093] [added: 15,983] | | | [added: | |] $ | [removed: 12,483] [added: 12,093] | | | [added: | |] $ | [removed: 10,282] [added: 12,483] | |

| Gross Profit [removed: (a)] | [added: | | 7,577 | | | | | |] 8,288 | | | | [added: | |] 7,269 | | | | [removed: 5,965] | | [added: 5,965] | | [removed: 6,018] | | | | [removed: 4,719] [added: 6,018] | | |

| Operating Income [removed: (a)] | [added: | | 1,484 | | | | | |] 1,760 | | | | [added: | |] 1,509 | | | | [removed: 1,522] | | [added: 1,522] | | [removed: 1,481] | | | | [removed: 1,119] [added: 1,481] | | |

| Income Before Income Taxes | [added: | | 985 | | | | | |] 1,176 | | | | [added: | |] 1,173 | | | | [removed: 976] | | [added: 976] | | [removed: 1,074] | | | | [removed: 739] [added: 1,074] | | |

| Income Tax [removed: (Benefit)] Provision [added: (Benefit)] | [removed: (57] | | [removed: )] [added: 111] | | [added: | | | | (57) | | | | | |] 862 | | | | [removed: (124] | | [removed: )] [added: (124)] | | [removed: 97] | | | | [removed: 44] [added: 97] | | |

| Net Income | [added: | | 874 | | | | | |] 1,233 | | | | [added: | |] 311 | | | | [removed: 1,100] | | [added: 1,100] | | [removed: 976] | | | | [removed: 695] [added: 976] | | |

| Basic Earnings Per Share | [added: | | 2.75 | | | | | |] 4.01 | | | | [added: | |] 0.62 | | | | [removed: 4.70] | | [added: 4.70] | | [removed: 4.59] | | | | [removed: 3.43] [added: 4.59] | | |

| Diluted Earnings Per Share | [added: | | 2.71 | | | | | |] 3.94 | | | | [added: | |] 0.60 | | | | [removed: 4.60] | | [added: 4.60] | | [removed: 4.49] | | | | [removed: 3.35] [added: 4.49] | | |

| Dividends Per Common Share | [added: | | 3.16 | | | | | |] 3.08 | | | | [added: | |] 3.00 | | | | [removed: 2.92] | | [added: 2.92] | | [removed: 2.64] | | | | [removed: 2.40] [added: 2.64] | | |

| Financial Position | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| Total Assets | [added: | | 54,012 | | | | | |] 51,765 | | | | [added: | |] 53,904 | | | | [removed: 37,734] | | [added: 37,734] | | [removed: 25,586] | | | | [removed: 26,478] [added: 25,586] | | |

| Total Long-Term Debt | [added: | | 17,224 | | | | | |] 18,081 | | | | [added: | |] 18,894 | | | | [removed: 18,667] | | [added: 18,667] | | [removed: 10,550] | | | | [removed: 11,370] [added: 10,550] | | |

| Total Shareholders’ Equity | [added: | | 23,765 | | | | | |] 21,081 | | | | [added: | |] 20,994 | | | | [removed: 12,948] | | [added: 12,948] | | [removed: 7,633] | | | | [removed: 7,164] [added: 7,633] | | |

| Additional Data | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | |]

| Average Common and Common Equivalent Shares Outstanding — Assuming Dilution (millions) | [added: | | 282.4 | | | | | |] 274.8 | | | | [added: | |] 264.6 | | | | [removed: 223.6] | | [added: 223.6] | | [removed: 217.5] | | | | [removed: 207.5] [added: 217.5] | | |

Additional discussion regarding the specified items in fiscal years [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] are provided in Item 7.

| | [added: | |] Years Ended September 30 | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| Millions of dollars, except per share amounts | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: 2017] | | [removed: 2016] | | | | [removed: 2015] [added: 2016] | | |

| Total specified items | [added: | |] $ | [removed: 2,749] [added: 2,510] | | | [added: | |] $ | [removed: 2,409] [added: 2,749] | | | [added: | |] $ | [removed: 1,466] [added: 2,409] | | | [added: | |] $ | [removed: 1,261] [added: 1,466] | | | [added: | |] $ | [removed: 1,186] [added: 1,261] | |

| After-tax impact of specified items | [added: | |] $ | [removed: 2,127] [added: 2,114] | | | [added: | |] $ | [removed: 2,674] [added: 2,127] | | | [added: | |] $ | [removed: 971] [added: 2,674] | | | [added: | |] $ | [removed: 892] [added: 971] | | | [added: | |] $ | [removed: 786] [added: 892] | |

| Impact of specified items on diluted earnings per share | [added: | |] $ | [removed: (7.74] [added: (7.49)] | [removed: )] | | [added: | |] $ | [removed: (10.11] [added: (7.74)] | [removed: )] | | [added: | |] $ | [removed: (4.34] [added: (10.11)] | [removed: )] | | [added: | |] $ | [removed: (4.10] [added: (4.34)] | [removed: )] | | [added: | |] $ | [removed: (3.79] [added: (4.10)] | [removed: )] |

| Dilutive impact from share issuances | [added: | |] $ | — | | | [added: | |] $ | [removed: (0.30] [added: —] | [removed: )] | | [added: | |] $ | [removed: (0.54] [added: (0.30)] | [removed: )] | | [added: | |] $ | [removed: —] [added: (0.54)] | | | [added: | |] $ | [removed: (0.02] [added: —] | [removed: )] |

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| (a) | Prior-year amounts were revised to reflect the recognition of all components of the Company’s net periodic pension and postretirement benefit costs, aside from service cost, to *Other income (expense), net* on its consolidated income statements, as is further discussed in Note 2 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. |

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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: 2019.][added: 2020.]

| /s/ [removed: Vincent A. Forlenza] [added: Thomas E. Polen] | | [added: | | | |] /s/ Christopher Reidy | | [added: | | | |] /s/ Thomas J. Spoerel | [added: | |]

| [removed: Vincent A. Forlenza] [added: Thomas E. Polen] | | [added: | | | |] Christopher Reidy | | [added: | | | |] Thomas J. Spoerel | [added: | |]

| [removed: *Chairman and Chief] [added: *Chief] Executive [removed: Officer*] [added: Officer and President*] | | [added: | | | |] *Executive Vice President, Chief Financial Officer and Chief Administrative Officer* | | [added: | | | |] *Vice President, Controller and Chief Accounting Officer* | [added: | |]

We have audited the accompanying consolidated balance sheets of Becton, Dickinson and Company (the Company) as of September 30, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] the related consolidated statements of income, comprehensive income and cash flows for each of the three years in the period ended September 30, [removed: 2019,] [added: 2020,] 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: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] and the results of its operations and its cash flows for each of the three years in the period ended September 30, [removed: 2019,] [added: 2020,] 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: 2019,] [added: 2020,] 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: 27, 2019] [added: 25, 2020] expressed an unqualified opinion.

| | | [added: | | | |] Estimation of Product Liability Reserves | [added: | |]

| *Description of the Matter* | | [added: | | | |] As described in Note 5 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: 2019,] [added: 2020,] the Company’s product liability reserves totaled approximately $2.5 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 [added: certain of] the [added: Company’s] product liability reserves and [added: 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. | [added: | |]

| *How We Addressed the Matter in Our Audit* | | [added: | | | |] We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s evaluation of the product liability reserve. For example, we tested controls over management's review of the methods, significant assumptions and the underlying data used by the actuary to estimate the product liability reserve. To evaluate management’s estimate of the product liability [removed: reserve,] [added: reserves,] our audit procedures included, among others, testing the completeness and accuracy of the underlying data used by management's actuarial specialist to estimate the amount of unreported claims and the indemnity cost. For example, we compared filed and settled claims data to legal letters obtained from external counsel, and, on a sample basis, compared settlement amounts to the underlying agreements. In addition, we involved our actuarial specialists to assist us in evaluating the methods used to estimate the unreported claims and the indemnity cost used in the calculation of the product liability reserves. We have also assessed the adequacy of the Company’s disclosures in relation to these matters. | [added: | |]

| | | [added: | | | |] Income taxes - Uncertain tax positions | [added: | |]

| [removed: *Description] [added: Description] of the [removed: Matter*] [added: Matter] | | [added: | | | |] As discussed in Notes 1 and 17 of the consolidated financial statements, the Company has recorded a liability of [removed: $624] [added: $719] million related to uncertain tax positions as of September 30, [removed: 2019.] [added: 2020.] 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 regulation 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 law and regulations in various jurisdictions, which is often subject to interpretation. | [added: | |]

| [removed: *How] [added: How] We Addressed the Matter in Our [removed: Audit*] [added: Audit] | | [added: | | | |] We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s income tax provision process, such as controls over management’s identification and assessment of changes to tax laws and income tax positions to account for uncertain tax positions, including management’s review of the related tax technical analyses. We performed audit procedures, among others, to evaluate the Company’s assumptions used to develop its uncertain tax positions and related unrecognized income tax benefit amounts by jurisdiction. We obtained an understanding of the Company’s legal structure through our 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 of those changes under the relevant jurisdiction’s tax law. Due to the complexity of tax law, we involved our tax subject matter professionals to assess the Company’s interpretation of and compliance with tax laws in these jurisdictions, as well as to identify tax law changes. We also involved our tax subject matter professionals to evaluate the technical merits of the Company’s accounting for its tax positions, including assessing the Company’s correspondence with the relevant tax authorities and evaluating third-party advice obtained by the Company. We also evaluated the Company’s income tax disclosures included in Note 17 to the consolidated financial statements in relation to these matters. | [added: | |]

| | | [added: | | | |] Goodwill impairment - Interventional segment | [added: | |]

| *Description of the Matter* | | [added: | | | |] At September 30, [removed: 2019,] [added: 2020,] the Company’s goodwill assigned to the Interventional segment was [removed: $12.6] [added: $12.7] 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 discount rate, revenue growth rate, operating margin, and terminal value, which are affected by expectations about future market or economic [removed: conditions.] [added: conditions, including the impact of the pandemic.] | [added: | |]

| *How We Addressed the Matter in Our Audit* | | [added: | | | |] 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. | [added: | |]

| /s/ ERNST & YOUNG LLP | | [added: | | | |]

| 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: 2019,] [added: 2020,] 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: 2019,] [added: 2020,] 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: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] the related consolidated statements of income, comprehensive income and cash flows for each of the three years in the period ended September 30, [removed: 2019,] [added: 2020,] and the related notes and our report dated November [removed: 27, 2019] [added: 25, 2020] expressed an unqualified opinion thereon.

| /s/ ERNST & YOUNG LLP | | [added: | | | |]

| New York, New York | | [added: | | | |]

[removed: Becton,] [added: Becton,] Dickinson and [removed: Company][added: Company, et al., Civ.]

| Millions of dollars, except per share amounts | [removed: 2019] | | [added: 2020] | | [removed: 2018] | | | | [removed: 2017] [added: 2019] | | | [added: | | | 2018 | | |]

| Revenues | [added: | |] $ | [removed: 17,290] [added: 17,117] | | | [added: | |] $ | [removed: 15,983] [added: 17,290] | | | [added: | |] $ | [removed: 12,093] [added: 15,983] | |

| Cost of products sold | [removed: 9,002] | | [added: 9,540] | | [removed: 8,714] | | | | [removed: 6,128] [added: 9,002] | | | [added: | | | 8,714 | | |]

| Selling and administrative expense | [removed: 4,332] | | [added: 4,325] | | [removed: 4,016] | | | | [removed: 2,909] [added: 4,332] | | | [added: | | | 4,016 | | |]

| Research and development expense | [removed: 1,062] | | [added: 1,096] | | [removed: 1,004] | | | | [removed: 770] [added: 1,062] | | | [added: | | | 1,004 | | |]

| Acquisitions and other restructurings | [removed: 480] | | [added: 309] | | [removed: 740] | | | | [removed: 354] [added: 480] | | | [added: | | | 740 | | |]

| Other operating expense, net | [removed: 654] | | [added: 363] | | [removed: —] | | | | [removed: 410] [added: 654] | | | [added: | | | — | | |]

| Total Operating Costs and Expenses | [removed: 15,530] | | [added: 15,633] | | [removed: 14,474] | | | | [removed: 10,571] [added: 15,530] | | | [added: | | | 14,474 | | |]

| Operating Income | [removed: 1,760] | | [added: 1,484] | | [removed: 1,509] | | | | [removed: 1,522] [added: 1,760] | | | [added: | | | 1,509 | | |]

| Interest expense | [removed: (639] | | [removed: )] [added: (528)] | | [removed: (706] | | [removed: )] | | [removed: (521] [added: (639)] | | [removed: )] | [added: | | | (706) | | |]

| Interest income | [removed: 12] | | [added: 7] | | [removed: 65] | | | | [removed: 76] [added: 12] | | | [added: | | | 65 | | |]

| Other [removed: income (expense),] [added: income,] net | [removed: 43] | | [added: 23] | | [removed: 305] | | | | [removed: (101] [added: 43] | | [removed: )] | [added: | | | 305 | | |]

| Income Before Income Taxes | [removed: 1,176] | | [added: 985] | | [removed: 1,173] | | | | [removed: 976] [added: 1,176] | | | [added: | | | 1,173 | | |]

| Income tax [removed: (benefit)] provision [added: (benefit)] | [removed: (57] | | [removed: )] [added: 111] | | [removed: 862] | | | | [removed: (124] [added: (57)] | | [removed: )] | [added: | | | 862 | | |]

| Net Income | [removed: 1,233] | | [added: 874] | | [removed: 311] | | | | [removed: 1,100] [added: 1,233] | | | [added: | | | 311 | | |]

| November 25, 2020 | | | | | |

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The Company also elected not to perform any reassessments relative to its expired and existing leases upon its adoption of the new requirements.

Additional disclosures regarding the Company’s lease arrangements are provided in Note 18.

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.

The adoption of this standard did not materially impact the Company's consolidated financial statements.

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.

| Preferred | | | — | | | | | | — | | | | | | (107) | | | | | | — | | | | | | — | | | | | | — | | |

| Preferred shares converted to common shares | | | 12 | | | | | | (9) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

| Balance at September 30, 2020 | | | $ | 365 | | | | | $ | 19,270 | | | | | $ | 12,791 | | | | | $ | 23 | | | | | (74,623) | | | | | | $ | (6,138) | |

Common and Preferred Stock Conversions and Offerings

In accordance with their terms, the Company's 2.475 million mandatory convertible preferred shares that were issued in May 2017 in connection with the Company's acquisition of Bard were converted into 11.703 million shares of BD common stock on the mandatory conversion date of May 1, 2020.

Also in May 2020, the Company completed registered public offerings of equity securities including:

- 6.250 million shares of the Company's common stock for net proceeds of $1.459 billion (gross proceeds of $1.500 billion).

- 1.500 million shares of the Company's mandatory convertible preferred stock (ownership is held in the form of depositary shares, each representing a 1/20th interest in a share of preferred stock) for net proceeds of $1.459 billion (gross proceeds of $1.500 billion).

The net proceeds from these offerings have been and will be used by the Company for general corporate purposes, which may include funding for the Company's growth strategy through organic investments and acquisitions, working capital, capital expenditures and repayment of outstanding indebtedness.

| Balance at September 30, 2020 | | | $ | (2,548) | | | | | $ | (1,416) | | | | | $ | (1,040) | | | | | $ | (91) | |

well as to terminated cash flow hedges.

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Becton, Dickinson and Company

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Becton, Dickinson and Company

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| Assets held for sale | — | | | | 137 | | |

Becton, Dickinson and Company

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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: 2019.][added: 2020.]

There were no changes in our internal control over financial reporting during the fiscal quarter ended September 30, [removed: 2019] [added: 2020] identified in connection with the above-referenced evaluation that have materially affected, or are reasonably likely to materially affect, BD’s internal control over financial reporting.

Not applicable.

As previously reported, the Board of Directors elected Thomas E.

Polen to serve as BD’s Chief Executive Officer and President, effective upon the conclusion of BD’s 2020 annual meeting of shareholders.

Upon assuming the role of Chief Executive Officer and President, Mr. Polen’s base salary will increase to $1,150,000 and his annual incentive award target will increase to 150% of base salary.

Election of Directors” and “Board of Directors - Committee membership and function - Audit Committee” 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: 2019] [added: 2020] (the [removed: “2020] [added: “2021] Proxy Statement”), and such information is incorporated herein by reference.

Certain other information required by this item will be contained under the captions “Ownership of BD Common Stock”, and "Corporate Governance - Code of Conduct” in BD’s [removed: 2020] [added: 2021] Proxy Statement, and such information is incorporated herein by reference.

The information required by this item will be contained under the captions “Compensation Discussion and Analysis,” “Report of the Compensation and Management Development Committee,” “Compensation of Named Executive Officers”, “Board of Directors - Non‑management [removed: directors’] [added: director] compensation,” and “CEO Pay Ratio" in BD’s [removed: 2020] [added: 2021] Proxy Statement, and such information is incorporated herein by reference.

The information required by this item will be contained under the caption “Ownership of BD Common Stock” [added: in BD’s 2021 Proxy Statement,] and [removed: "Proposal 4.][added: such information is incorporated herein by reference.]

Approval of Amendment to 2004 Plan" in BD’s 2020 Proxy Statement, and such information is incorporated herein by reference.

The information required by this item will be contained under the caption “Corporate Governance - Director independence; Policy regarding related person transactions” in BD’s [removed: 2020] [added: 2021] Proxy Statement, and such information is incorporated herein by reference.