The following commentary should be read in conjunction with the consolidated financial statements and accompanying notes presented in this report. Within the tables presented throughout this discussion, certain columns may not add due to the use of rounded numbers for disclosure purposes. Percentages and earnings per share amounts presented are calculated from the underlying amounts. References to years throughout this discussion relate to our fiscal years, which end onSeptember 30 . Company Overview Description of the Company and Business SegmentsBecton, Dickinson and Company ("BD") is a global medical technology company engaged in the development, manufacture and sale of a broad range of medical supplies, devices, laboratory equipment and diagnostic products used by healthcare institutions, physicians, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. The Company's organizational structure is based upon three principal business segments, BD Medical ("Medical"), BD Life Sciences ("Life Sciences") and BD Interventional ("Interventional"). BD's products are manufactured and sold worldwide. Our products are marketed inthe United States and internationally through independent distribution channels and directly to end-users by BD and independent sales representatives. We organize our operations outsidethe United States as follows: EMEA (which includesEurope , theMiddle East andAfrica );Greater Asia (which includes countries inGreater China ,Japan ,South Asia ,Southeast Asia ,Korea ,Australia and New Zealand );Latin America (which includesMexico ,Central America , theCaribbean andSouth America ); andCanada . We continue to pursue growth opportunities in emerging markets, which include the following geographic regions:Eastern Europe , theMiddle East ,Africa ,Latin America and certain countries withinGreater Asia . We are primarily focused on certain countries whose healthcare systems are expanding. Strategic Objectives BD remains focused on delivering durable growth and creating shareholder value, while making appropriate investments for the future. BD 2025, our vehicle for value creation, is anchored in three key pillars: grow, simplify and empower. BD's management team aligns our operating model and investments with these key strategic pillars through continuous focus on the following underlying objectives: Grow •Developing and maintaining a strong portfolio of leading products and solutions that address significant unmet clinical needs, improve outcomes, and reduce costs; •Focusing on our core products, services and solutions that deliver greater benefits to patients, healthcare workers and researchers; •Investing in research and development that leads to and expands category leadership, as well as results in a robust product pipeline; •Leveraging our global scale to expand our reach in providing access to affordable medical technologies around the world, including emerging markets; •Supplementing our internal growth through strategic acquisitions in faster growing market segments; •Driving an efficient capital structure and strong shareholder returns. Simplify •Driving operating effectiveness and margin expansion by placing controls on sourcing and transportation costs, as well as by increasing labor productivity and asset efficiencies; •Focusing on cash management in order to improve balance sheet productivity; •Working across our supply chain to reduce environmental impacts; 24 -------------------------------------------------------------------------------- Table of Contents •Creating more resilient operations based on an enterprise-wide renewable energy strategy; •Reducing complexity across our manufacturing network and rationalizing our product portfolio to optimize architecture, portfolio and business processes; •Enhancing our quality and risk management systems; •Simplifying our internal business processes. 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. In assessing the outcomes of these strategies as well as BD's financial condition and operating performance, management generally reviews forecast data, monthly actual results, including segment sales, and other similar information. We also consider trends related to certain key financial data, including gross profit margin, selling and administrative expense, investment in research and development, return on invested capital, and cash flows. BD's Intention to Spin Off Diabetes Care OnMay 6, 2021 , we announced our intention to spin off our Diabetes Care business as a separate publicly traded company to BD's shareholders. The proposed spin-off is intended to be a tax-free transaction forU.S. federal income tax purposes and is expected to be completed in the first half of calendar year 2022, subject to the satisfaction of customary conditions, including final approval from BD's Board of Directors and the effectiveness of a registration statement on Form 10. The Company believes that as an independent, publicly traded entity, the Diabetes Care business will be positioned to more effectively allocate its capital and operational resources with a dedicated growth strategy. For further discussion of risks relating to the proposed spin-off of our Diabetes Care business, see Item 1A. Risk Factors-Risks Relating to the Proposed Spin-off of the Diabetes Care Business. COVID-19 Pandemic Impacts and Response A novel strain of coronavirus disease ("COVID-19") was officially declared a pandemic by theWorld Health Organization inMarch 2020 and governments around the world have been implementing various measures to slow and control the ongoing spread of COVID-19. These government measures, as well as a shift in healthcare priorities, resulted in a significant decline in medical procedures in our fiscal year 2020. Demand for our products showed substantial recovery in our fiscal year 2021; however, regional resurgences in COVID-19 infections and the emergence of the Delta variant continued to impact the demand for certain of our products in our fiscal year 2021. Our 2021 revenues reflected a substantial benefit from sales related to COVID-19 diagnostic testing on the BD VeritorTM Plus and BD MaxTM Systems. The factors that affected our revenue growth in fiscal year 2021, including those related to the COVID-19 pandemic, are discussed in greater detail further below. Due to the 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, may be subject to volatility. While non-acute utilization rates for most of our products have largely recovered to pre-pandemic levels, resurgences in COVID-19 infections or new strains of the virus may weaken future demand for certain of our products and/or disrupt our operations. We also continue to see challenges posed by the pandemic to global transportation channels and other aspects of our supply chain, including the cost and availability of raw materials, as well as logistical challenges affecting the movement of freight around the globe.The United States and other governments may enact or use laws and regulations, such as the Defense Production Act or export restrictions, to ensure availability of needed COVID-19 testing and vaccination delivery devices. Any such action may impact our global supply chain network. 25
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The impacts of the COVID-19 pandemic on our business, results of operations, financial condition and cash flows is dependent on certain factors including: •The extent to which resurgences in COVID-19 infections or new strains of the virus, including the Delta variant, result in future deferrals of elective medical procedures and/or the extent to which the imposition of new governmental lockdowns, quarantine requirements or other restrictions may weaken demand for certain of our products and/or disrupt our operations; •The degree to which demand and pricing for our COVID-19 diagnostics testing solutions continues to be impacted by reduced infection rates, as well as by distribution and utilization of available COVID-19 vaccines and the availability of competitive SARS-CoV-2 diagnostic testing products, which we expect will result in lower COVID-19 testing revenues in future periods; •The degree to which the pandemic has escalated challenges that existed for global healthcare systems prior to the pandemic, such as staffing shortages, including nursing shortages, and budget constraints; •The continued momentum of the global economy's recovery from the pandemic and the degree of pressure that a weakened macroeconomic environment would put on future healthcare utilization and the global demand for our products. We remain focused on partnering with governments, healthcare systems, and healthcare professionals to navigate the COVID-19 pandemic. This focus includes providing access to our SARS-CoV-2 diagnostics tests and injection devices for global vaccination campaigns, as well as supplying products and solutions for ongoing care for patients around the world. We have also remained focused on protecting the health and safety of BD employees while ensuring continued availability of BD's critical medical devices and technologies during these unprecedented times. Summary of Financial Results Worldwide revenues in 2021 of$20.248 billion increased 18.3% from the prior-year period, which primarily reflected an increase in volume, including increases attributable to our core products, of approximately 15.3%. Revenues in 2021 also reflected a favorable impact from foreign currency translation of approximately 2.7%, as well as a favorable impact from price of approximately 0.3%. Volume in 2021 reflected increased demand for our broad portfolio of products and was driven by the following: •The Medical segment's revenues in 2021 reflected increased demand in the Medication Delivery Solutions, Pharmaceutical Systems and Diabetes Care units, which was partially offset by a decline in the Medication Management Solutions unit. •The Life Sciences segment's revenues in 2021 reflected growth in both units. Growth in the Integrated Diagnostic Solutions unit included approximately$2 billion of revenues driven by COVID-19 diagnostic testing primarily on the BD VeritorTM Plus and BD MaxTM Systems. •Interventional segment revenues in 2021 reflected increased demand in all three units as hospital utilization increased and new product offerings drove higher sales. We continue to invest in research and development, geographic expansion, and new product programs to drive further revenue and profit growth. We have reinvested over$200 million of the profits from our sales related to COVID-19 diagnostic testing into our BD 2025 strategy. Our ability to sustain our long-term growth will depend on a number of factors, including our ability to expand our core business (including geographical expansion), develop innovative new products, and continue to improve operating efficiency and organizational effectiveness. As discussed above, current global economic conditions remain relatively volatile due to the COVID-19 pandemic. In addition, an inability to increase or maintain selling prices globally could adversely impact our businesses. Also, we are experiencing challenges related to global transportation channels and supply chains. These challenges have subjected certain of our costs, specifically raw material and freight costs, to inflationary pressures which have unfavorably impacted our gross profit and operating margins. Additional 26 -------------------------------------------------------------------------------- Table of Contents discussion regarding the impacts of these inflationary pressures on our operating results in 2021 is provided further below. Our financial position remains strong, with cash flows from operating activities totaling$4.647 billion in 2021. AtSeptember 30, 2021 , we had$2.403 billion in cash and equivalents and short-term investments, including restricted cash. We continued to return value to our shareholders in the form of dividends. During fiscal year 2021, we paid cash dividends of$1.048 billion , including$958 million paid to common shareholders and$90 million paid to preferred shareholders. We also repurchased approximately$1.750 billion of our common stock during fiscal year 2021. Each reporting period, we face currency exposure that arises from translating the results of our worldwide operations to theU.S. dollar at exchange rates that fluctuate from the beginning of such period. A weakerU.S. dollar, compared to the prior-year period, resulted in a favorable foreign currency translation impact to our revenues and an unfavorable impact to our expenses during 2021. We evaluate our results of operations on both a reported and a foreign currency-neutral basis, which excludes the impact of fluctuations in foreign currency exchange rates. As exchange rates are an important factor in understanding period-to-period comparisons, we believe the presentation of results on a foreign currency-neutral basis in addition to reported results helps improve investors' ability to understand our operating results and evaluate our performance in comparison to prior periods. Foreign currency-neutral ("FXN") information compares results between periods as if exchange rates had remained constant period-over-period. We use results on a foreign currency-neutral basis as one measure to evaluate our performance. We calculate foreign currency-neutral percentages by converting our current-period local currency financial results using the prior-period foreign currency exchange rates and comparing these adjusted amounts to our current-period results. These results should be considered in addition to, not as a substitute for, results reported in accordance withU.S. generally accepted accounting principles ("GAAP"). Results on a foreign currency-neutral basis, as we present them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance withU.S. GAAP. Results of Operations Medical Segment The following summarizes Medical revenues by organizational unit: 2021 vs. 2020 2020 vs. 2019 Estimated Estimated Total FX Total FX (Millions of dollars) 2021 2020 2019 Change Impact FXN Change Change Impact FXN Change Medication Delivery Solutions$ 4,057 $ 3,555 $ 3,848 14.1 % 2.4 % 11.7 % (7.6) % (1.4) % (6.2) % Medication Management Solutions 2,432 2,454 2,640 (0.9) % 1.4 % (2.3) % (7.1) % (0.5) % (6.6) % Diabetes Care 1,160 1,084 1,110 7.0 % 2.2 % 4.8 % (2.4) % (1.4) % (1.0) %
Pharmaceutical Systems 1,829 1,588 1,465 15.2 % 4.1 % 11.1 % 8.4 % (1.0) % 9.4 % Total Medical revenues$ 9,479 $ 8,680 $ 9,064 9.2 % 2.4 % 6.8 % (4.2) % (1.0) % (3.2) % The Medical segment's revenue growth in 2021 was aided by a favorable comparison to 2020, which was impacted by COVID-19 pandemic-related declines, particularly inthe United States andChina . These prior-year pandemic-related declines impacted our Medication Delivery Solutions unit, and to a lesser extent, the Diabetes Care unit. Fiscal year 2021 revenue growth in the Medication Delivery Solutions unit reflected strong demand for our core offerings, includingU.S. demand for catheters and vascular care products, as well as strong global demand for syringes resulting from COVID-19 vaccination efforts. In the Medication Management 27 -------------------------------------------------------------------------------- Table of Contents Solutions unit, lower revenues in 2021 reflected an unfavorable comparison to 2020, which benefited from global pandemic-related infusion pump orders. Growth in the Diabetes Care unit benefited from the timing of sales, slightly better than expected market demand and a favorable comparison to 2020, which was impacted by pandemic-related declines. The Pharmaceutical Systems unit's revenue growth in 2021 reflected continued strong growth that is being driven by demand for our pre-filled devices and is enabled by capacity expansion efforts. Demand for pre-filled devices is being aided by the vial to pre-filled device conversion for biologics, vaccines, and other injectable drugs. As previously disclosed, we submitted our 510(k) premarket notification to the FDA for the BD Alaris™ System inApril 2021 . The 510(k) submission is intended to bring the regulatory clearance for the BD Alaris™ System up-to-date, implement new features to address the open recall issues and provide other updates, including a new version of the BD Alaris™ System software that will provide clinical, operational and cybersecurity updates. We are currently shipping the BD Alaris™ System inthe United States , only in cases of medical necessity and to remediate recalled software versions. We will not be able to fully resume commercial operations for the BD Alaris System™ inthe United States until a 510(k) submission relating to the product has been cleared by the FDA. No assurances can be given as to when or if clearance will be obtained from the FDA. The Medication Delivery Solutions unit's revenues in 2020 reflected an unfavorable impact relating to the COVID-19 pandemic due to a decline in healthcare utilization, particularly inthe United States ,China andEurope . As expected, the Medication Delivery Solutions unit's 2020 revenues inChina were also unfavorably impacted by a volume-based procurement process which was adopted by several ofChina's provinces. The Medication Management Solutions unit's revenues in 2020 reflected a hold onU.S. shipments of BD AlarisTM infusion pumps pending compliance with certain 510(k) filing requirements of the FDA. This unfavorable impact was partially offset by international sales of infusion pumps and pandemic-related infusion pump orders placed inthe United States with medical necessity certification. Fiscal year 2020 revenues in the Diabetes Care unit were unfavorably impacted by pandemic-related declines in demand and pricing pressures inthe United States . The Pharmaceutical Systems unit's revenues in 2020 reflected continued strength in demand for prefillable products. Medical segment operating income was as follows: (Millions of dollars) 2021
2020 2019
Medical segment operating income$ 2,583 $
2,274
Segment operating income as % of Medical revenues 27.3 % 26.2 % 31.2 %
As discussed in greater detail below, the Medical segment's operating income in 2021 was driven by higher gross profit margin. Operating income in 2020 was driven by a decline in gross profit margin. •The Medical segment's higher gross profit margin in 2021 compared with 2020 primarily reflected the following: •A favorable comparison to 2020, which was unfavorably impacted by increased levels of manufacturing overhead costs that were recognized in the period because of the COVID-19 pandemic, rather than capitalized within inventory, and$244 million of net charges recorded in 2020, compared with charges of$56 million in 2021, for estimated future costs within the Medication Management Solutions unit associated with remediation efforts related to AlarisTM infusion pumps; •Lower manufacturing costs resulting from continuous improvement projects which enhanced the efficiency of our operations; 28 -------------------------------------------------------------------------------- Table of Contents •The unfavorable impacts from foreign currency translation, investments in simplification and other cost saving initiatives, higher raw material and freight costs, as well as product quality remediation expenses. •The Medical segment's lower gross profit margin in 2020 compared with 2019 primarily reflected the following: •Net charges of$244 million recorded for remediation efforts related to AlarisTM infusion pumps, as noted above; •Unfavorable product mix and the increased levels of manufacturing overhead costs that were recognized in the period because of the COVID-19 pandemic and unfavorable product mix driven by the decline of sales inChina due to the volume-based procurement process noted above; •Charges of$41 million recorded to write down the carrying value of certain fixed assets, primarily within the Medication Delivery Solutions and Pharmaceutical Systems units; •The favorable impact of lower manufacturing costs resulting from continuous improvement projects which enhanced the efficiency of our operations. •Selling and administrative expense as a percentage of revenues in 2021 was flat compared with 2020, primarily due to the increase in revenues in 2021, partially offset by higher travel and other administrative costs compared with 2020, which benefited from cost containment measures enacted in response to the COVID-19 pandemic. Selling and administrative expense as a percentage of revenues in 2020 was slightly lower compared with 2019 primarily due to lower expenses resulting from cost containment measures. •Research and development expense as a percentage of revenues was higher in 2021 compared with 2020 which primarily reflects our commitment to research and development through continued reinvestment into our growth initiatives. Research and development expense as a percentage of revenues was higher in 2020 compared with 2019 which reflected the decline in revenues in 2020, as well as our continued commitment to drive innovation with new products and platforms. •The Medical segment's income in 2019 additionally reflected the estimated cumulative costs of a product recall of$75 million recorded within Other operating expense, net. The recall related to a product component, which generally pre-dated our acquisition ofCareFusion in fiscal year 2015, within the Medication Management Solutions unit's infusion systems platform. Life Sciences Segment The following summarizes Life Sciences revenues by organizational unit: 2021 vs. 2020 2020 vs. 2019 Estimated Estimated Total FX Total FX (Millions of dollars) 2021 2020 2019 Change Impact FXN Change Change Impact FXN Change Integrated Diagnostic Solutions$ 5,225 $ 3,532 $ 3,106 47.9 % 3.8 % 44.1 % 13.7 % (1.4) % 15.1 % Biosciences 1,305 1,143 1,194 14.2 % 3.1 % 11.1 % (4.3) % (0.8) % (3.5) % Total Life Sciences revenues$ 6,530 $ 4,675 $ 4,300 39.7 % 3.6 % 36.1 % 8.7 % (1.2) % 9.9 %
The Life Sciences segment's revenue growth in 2021 primarily reflected a favorable comparison to 2020, which was significantly impacted by pandemic-related declines in both units. Revenue growth in the Integrated Diagnostic Solutions unit was also driven by sales related to COVID-19 diagnostic testing on the BD VeritorTM
29 -------------------------------------------------------------------------------- Table of Contents Plus and BD MaxTM Systems. Routine diagnostic testing levels in the Integrated Diagnostic Solutions unit continued to improve over the course of 2021 and the unit benefited from high demand for our specimen management portfolio, automated blood cultures and ID/AST testing solutions. The Biosciences unit's revenue growth in 2021 benefited from strong demand for instruments and reagents as lab utilization returned to normal levels. The Life Sciences segment's revenues in 2020 were driven by the Integrated Diagnostic Solutions unit's sales, specifically in the fourth quarter, related to COVID-19 diagnostic testing on the BD VeritorTM Plus and BD MaxTM Systems. This growth in the Integrated Diagnostic Solutions unit was partially offset by pandemic-related declines in routine diagnostic testing and specimen collections. The Biosciences unit's revenues in 2020 reflected a decline in demand for instruments and reagents as routine research and clinical lab activity slowed due to the COVID-19 pandemic. Life Sciences segment operating income was as follows: (Millions of dollars) 2021 2020 2019
Life Sciences segment operating income
Segment operating income as % of Life Sciences revenues 36.6 % 30.0 % 29.0 % As discussed in greater detail below, the Life Sciences segment's operating income in 2021 reflected improved gross profit margin and operating expense performance. Operating income in 2020 reflected improved operating expense performance, partially offset by a decline in gross profit margin. •The Life Sciences segment's higher gross profit margin in 2021 compared with 2020 primarily reflected the following: •A favorable impact on product mix from the Integrated Diagnostic Solutions unit's sales related to COVID-19 testing and the recovery of demand for other products with higher margins; •A favorable comparison to the prior-year period which was unfavorably impacted by increased levels of manufacturing overhead costs that were recognized in the period because of the COVID-19 pandemic, rather than capitalized within inventory; •The unfavorable impacts of foreign currency translation and the recognition of approximately$93 million of excess and obsolete inventory expenses related to COVID-19 testing inventory. •The Life Sciences segment's lower gross profit margin in fiscal year 2020 compared with 2019 primarily reflected the following: •Unfavorable product mix and the increased levels of manufacturing overhead costs that were recognized in the period because of the COVID-19 pandemic; •A charge of$39 million recorded in 2020 to write down the carrying value of certain intangible assets in the Biosciences unit and charges of$17 million recorded in 2020 to write down fixed assets in the Integrated Diagnostic Solutions unit; •The favorable impact on product mix from the Integrated Diagnostic Solutions unit's sales related to COVID-19 testing. •Selling and administrative expense as a percentage of Life Sciences revenues in 2021 was lower compared with the 2020 primarily due to the increase in revenues in 2021, partially offset by higher travel and other administrative costs compared with 2020, which benefited from cost containment measures enacted in response to the COVID-19 pandemic, as well as higher shipping costs and selling costs in 2021 associated with COVID-19 testing solutions. Selling and administrative expense as a 30 -------------------------------------------------------------------------------- Table of Contents percentage of Life Sciences revenues in 2020 was lower compared to 2019 primarily due to the increase in revenues that was attributable to COVID-19 testing. Lower selling and administrative expense as a percentage of revenues in 2020 was also driven by cost containment measures and synergies realized from the combination, effective onOctober 1, 2019 , of the former Preanalytical Systems and Diagnostic Systems units to create the Integrated Diagnostic Solutions unit. •Research and development expense as a percentage of revenues in 2021 was lower compared with 2020, primarily due to the increase in revenues in 2021, partially offset by additional investments in COVID-19 testing solutions. Research and development expense as a percentage of revenues in 2020 was flat compared with 2019 as the increase in revenues that was attributable to COVID-19 testing was largely offset by investments in COVID-19 testing solutions. Interventional Segment The following summarizes Interventional revenues by organizational unit: 2021 vs. 2020 2020 vs. 2019 Estimated Estimated Total FX Total FX (Millions of dollars) 2021 2020 2019 Change Impact FXN Change Change
Impact FXN Change Surgery$ 1,296 $ 1,121 $ 1,242 15.7 % 1.3 % 14.4 % (9.7) % (0.3) % (9.4) % Peripheral Intervention 1,711 1,511 1,574 13.2 % 3.0 % 10.2 % (4.0) % (0.9) % (3.1) % Urology and Critical Care 1,232 1,130 1,110 9.0 % 1.4 % 7.6 % 1.8 % (0.2) % 2.0 % Total Interventional revenues$ 4,239 $ 3,762 $ 3,926 12.7 % 2.0 % 10.7 % (4.2) % (0.5) % (3.7) % The Interventional segment's revenues in 2021 reflected a favorable comparison to 2020, which was significantly impacted by pandemic-related declines in our Surgery and Peripheral Intervention units. Fiscal year 2021 revenue growth in the Interventional segment was also driven by stronger market demand for the Surgery unit's infection prevention platform and the Peripheral Intervention unit's oncology products. Revenues in the Peripheral Intervention unit additionally benefited from sales attributable to its acquisition ofStraub Medical AG , which occurred in the third quarter of fiscal year 2020. Fiscal year 2021 revenue growth in our Surgery and Peripheral Intervention units was unfavorably impacted by regional resurgences in COVID-19 infections and the emergence of the Delta variant. The Urology and Critical Care unit's growth in 2021 showed strong demand for acute urology products and the unit's targeted temperature management portfolio. The Interventional segment's revenues in 2020, particularly within the Surgery and Peripheral Intervention units, were negatively impacted by decreased demand associated with the deferral of elective medical procedures as a result of the COVID-19 pandemic. Pandemic-related revenue declines in the Urology and Critical Care unit were offset by demand for the unit's home care and targeted temperature management businesses, and PureWickTM system. Interventional segment operating income was as follows: (Millions of dollars) 2021
2020 2019
Interventional segment operating income$ 933 $
724
Segment operating income as % of Interventional revenues 22.0 % 19.2 % 23.0 %
31 -------------------------------------------------------------------------------- Table of Contents As discussed in greater detail below, the Interventional segment's operating income in 2021 was primarily driven by improved gross profit margin. Operating income in 2020 was driven by a decline in gross profit margin. •The Interventional segment's higher gross profit margin in 2021 compared with 2020 primarily reflected the following: •The recovery of demand for products with higher margins; •A favorable comparison to the prior-year period which was unfavorably impacted by increased levels of manufacturing overhead costs that were recognized in the period because of the COVID-19 pandemic, rather than capitalized within inventory. •The Interventional segment's lower gross profit margin in fiscal year 2020 compared with 2019 primarily reflected unfavorable product mix and the increased levels of manufacturing overhead costs that were recognized in the period because of the COVID-19 pandemic. •Selling and administrative expense as a percentage of revenues in 2021 was lower compared with 2020 primarily due the recovery of segment revenues. Selling and administrative expense in 2020 was lower compared with 2019 primarily due to lower expenses resulting from cost containment measures. •Research and development expense as a percentage of revenues was higher in 2021 compared with 2020 which primarily reflects reinvestment into our growth initiatives. Lower research and development expense as a percentage of revenues in 2020 as compared with 2019 primarily reflected the prior-period impact of a$30 million write-down recorded by the Surgery unit. •The Interventional segment's lower income in 2020 additionally reflected the expiration in 2019 of a royalty income stream acquired in the Bard transaction. Geographic Revenues BD's worldwide revenues by geography were as follows: 2021 vs. 2020 2020 vs. 2019 Estimated Estimated Total FX Total FX (Millions of dollars) 2021 2020 2019 Change Impact FXN Change Change Impact FXN ChangeUnited States $ 10,969 $ 9,716 $ 9,730 12.9 % - 12.9 % (0.1) % - (0.1) % International 9,279 7,401 7,560 25.4 % 6.2 % 19.2 % (2.1) % (2.2) % 0.1 % Total revenues$ 20,248 $ 17,117 $ 17,290 18.3 % 2.7 % 15.6 % (1.0) % (1.0) % - %U.S. revenue growth in 2021 was primarily driven by sales related to COVID-19 diagnostic testing in the Life Sciences segment's Integrated Diagnostic Solutions unit, as noted above. Strong fiscal year 2021 U.S. revenue growth in the Medical segment's Medication Delivery Solutions unit and the Interventional segment's Surgery and Peripheral Intervention units reflected favorable comparisons to prior-year period results, which were impacted by COVID-19 pandemic-related declines, as well as growth attributable to core products.U.S. revenue growth in 2021 also reflected strong demand in the Interventional segment's Urology and Critical Care unit.U.S. revenues in 2020 were relatively flat compared with 2019 as the Life Sciences segment's Integrated Diagnostic Solutions unit's sales related to COVID-19 diagnostic testing largely offset the declines noted above for the Medical segment's Medication Management Solutions and Medication Delivery Solutions units, as well as for the Interventional segment's Surgery and Peripheral Intervention units. International revenue growth in 2021 was largely driven by COVID-19 diagnostic testing-related sales in the Life Sciences segment's Integrated Diagnostic Solutions unit, as discussed further above, and by demand in the Medical segment's Pharmaceutical Systems unit. Fiscal year 2021 international revenue growth was also 32 -------------------------------------------------------------------------------- Table of Contents driven by results in the Medical segment's Medication Delivery Solutions and the Interventional segment's Peripheral Intervention unit due to favorable comparisons to prior-year period results, which were impacted by COVID-19 pandemic-related declines, and growth attributable to core products. Fiscal year 2021 international revenue growth was unfavorably impacted by a decline in the Medical segment's Medication Management Solutions unit, as further discussed above. International revenues in 2020 were favorably impacted by sales in the Medical segment's Pharmaceutical Systems and Medication Management Solutions units as well as by sales in the Life Sciences segment's Integrated Diagnostic Solutions unit, as discussed further above. International revenues in 2020 were unfavorably impacted by revenue declines inChina andEurope for the Medical segment's Medication Delivery Solutions unit, as previously discussed. Emerging market revenues were as follows: 2021 vs. 2020 2020 vs. 2019 Estimated Estimated Total FX Total FX (Millions of dollars) 2021 2020 2019 Change Impact FXN Change Change Impact FXN Change Emerging markets$ 2,866 $ 2,419 $ 2,710 18.5 % 2.9 % 15.6 % (10.7) % (3.6) % (7.1) % Revenues in emerging markets in 2021 benefited from a favorable comparison to 2020 which was impacted by COVID-19 pandemic-related declines. Revenues in emerging markets in 2020 were unfavorably impacted by a decline in healthcare utilization as a result of the COVID-19 pandemic. As previously discussed above, fiscal year 2020 revenues in our Medication Delivery Solutions unit were also unfavorably impacted by a volume-based procurement process which was adopted by several ofChina's provinces. To date, the impact of these procurement initiatives to our revenues inChina has been limited to our Medication Delivery Solutions unit. Specified Items Reflected in the financial results for 2021, 2020 and 2019 were the following specified items: (Millions of dollars) 2021 2020 2019 Integration costs (a)$ 135 $ 214 $ 323 Restructuring costs (a) 50 95 180 Separation and related costs (b) 35 - - Purchase accounting adjustments (c) 1,406 1,356 1,499
Transaction gain/loss, product and other litigation-related matters (d)
272 631 646 Investment gains/losses and asset impairments (e) (46) 100 17 European regulatory initiative-related costs (f) 135 106 51 Impacts of debt extinguishment 185 8 54 Hurricane recovery-related impacts - - (24) Total specified items 2,170 2,510 2,749 Less: tax impact of specified items and tax reform (g) 353 395 622 After-tax impact of specified items$ 1,818
(a)Represents integration and restructuring costs recorded in Acquisitions and other restructurings, which are further discussed below. (b)Represents costs recorded to Other operating expense, net which were incurred for consulting, legal, tax and other advisory services associated with the planned spin-off of BD's Diabetes Care business. 33 -------------------------------------------------------------------------------- Table of Contents (c)Includes amortization and other adjustments related to the purchase accounting for acquisitions impacting identified intangible assets and valuation of fixed assets and debt. BD's amortization expense is primarily recorded in Cost of products sold. (d)Includes amounts recorded to Other operating expense, net which are detailed further below. The amounts in 2021 and 2020 also included net charges related to the estimate of probable future product remediation costs, as further discussed below. Such amounts are recorded within Cost of products sold, or in some cases, within Other (expense) income, net. (e)The amount in 2021 reflected unrealized gains recorded within Other (expense) income, net relating to investments. The amount in 2020 and 2019 included total charges of$98 million , and$30 million , respectively, recorded in Cost of products sold and Research and development expense to write down the carrying value of certain assets. The amount in 2019 also included an unrealized gain of$13 million recorded within Other (expense) income, net relating to an investment. (f)Represents costs required to develop processes and systems to comply with regulations such as the European Union Medical Device Regulation ("EUMDR") and General Data Protection Regulation ("GDPR"). These costs were recorded in Cost of products sold and Research and development expense. (g)The amount in 2019 included additional tax benefit, net, of$50 million relating toU.S. tax legislation which is further discussed in Note 16 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Gross Profit Margin The comparison of gross profit margins in 2021 and 2020 and the comparison of gross profit margins in 2020 and 2019 reflected the following impacts: 2021 2020 Gross profit margin % prior-year period 44.3 % 47.9 % Impact of purchase accounting adjustments and other specified items 2.7
% (2.0) %
Operating performance 0.2 % (1.5) % Foreign currency translation (0.6) % (0.1) % Gross profit margin % current-year period 46.6
% 44.3 %
The impacts of other specified items on gross profit margin reflected the following: •The impacts in 2021 and 2020 includes net charges of$56 million and$244 million , respectively, to record estimated future costs within the Medication Management Solutions unit associated with remediation efforts related to BD AlarisTM infusion pumps. Based upon the course of our remediation efforts, our estimate of these future costs may change over time. •The impact in 2020 also includes$59 million of charges that were recorded to write down the carrying value of certain fixed assets in the Medical and Life Sciences segments, as discussed further above, and a$39 million charge to write down the carrying value of certain intangible assets in the Biosciences unit. Operating performance in 2021 and 2020 primarily reflected the following: •Favorable product mix in 2021 was driven by the recovery of demand for products with higher margins and the Integrated Diagnostic Solutions unit's COVID-19 testing sales. We re-invested over$200 million of the profits from these sales into our BD 2025 strategy focus on growth, simplification and empowerment. Unfavorable product mix in 2020 due to pandemic-related declines was partially offset by the Integrated Diagnostic Solutions unit's sales related to COVID-19 testing. •Operating performance in 2021 benefited from a favorable comparison to 2020 which was unfavorably impacted by increased levels of manufacturing overhead costs that were recognized in the period 34 -------------------------------------------------------------------------------- Table of Contents because of the COVID-19 pandemic, rather than capitalized within inventory. The higher levels of manufacturing overhead costs incurred in 2020 were driven, to a large extent, by the impact of lower plant utilization in our highly automated manufacturing sites. •Operating performance in 2021 reflected approximately$93 million of excess and obsolete inventory expenses related to COVID-19 testing inventory which were recognized by the Integrated Diagnostic Solutions unit. •Lower manufacturing costs resulting from continuous improvement projects and synergy initiatives favorably impacted operating performance in 2021 and 2020. This favorable impact was largely offset by higher raw material costs in 2021. Operating Expenses Operating expenses in 2021, 2020 and 2019 were as follows: Increase (decrease) in basis points (Millions of dollars) 2021 2020 2019 2021 vs. 2020 2020 vs. 2019 Selling and administrative expense$ 4,867 $ 4,325 $ 4,332 % of revenues 24.0 % 25.3 % 25.1 % (130) 20 Research and development expense$ 1,339 $ 1,096 $ 1,062 % of revenues 6.6 % 6.4 % 6.1 % 20 30 Acquisitions and other restructurings$ 185 $ 309 $ 480 Other operating expense, net$ 238 $ 363 $ 654 Selling and administrative Selling and administrative expense as a percentage of revenues in 2021 was lower compared with 2020 due to the recovery of revenues in 2021. Selling and administrative expense as a percentage of revenues in 2021 was unfavorably impacted by foreign currency translation and higher shipping costs as a result of expedited shipments relating to COVID-19, as well as by higher selling, travel and other administrative costs compared with 2020, which benefited from cost containment measures enacted in response to the COVID-19 pandemic. Slightly higher selling and administrative expense as a percentage of revenues in 2020 compared with 2019 reflected the decline in revenues in 2020, higher shipping costs as a result of expedited shipments relating to COVID-19, as well as$25 million of funding for theBD Foundation . These unfavorable impacts were partially offset by lower selling expenses and favorable foreign currency translation. Selling and administrative spending in 2020 reflected a disciplined spending and the achievement of cost synergies resulting from our acquisition of Bard, as well as cost containment measures enacted to mitigate the impact of the COVID-19 pandemic on our results of operations. Research and development Research and development expense as a percentage of revenues in 2021 was higher compared with 2020 which reflected our reinvestment of COVID-19 testing-related sales profits into our growth initiatives and additional investments in COVID-19 testing solutions, as further discussed above. Research and development expense as a percentage of revenues in 2020 was higher compared with 2019 primarily due to investments in compliance with emerging regulations and investments in COVID-19 testing solutions, as further discussed above. Spending in 2021, 2020 and 2019 reflected our continued commitment to 35 -------------------------------------------------------------------------------- Table of Contents invest in new products and platforms. As further discussed above, expenses in 2019 included certain write-down charges in the Surgery unit. Acquisitions and other restructurings Costs relating to acquisitions and other restructurings in 2021 and 2020 included integration costs incurred due to our acquisition of Bard in the first quarter of fiscal year 2018. Costs in 2021 and 2020 additionally included restructuring costs related to simplification and cost saving initiatives. Costs relating to acquisition and other restructurings in 2020 and 2019 also included restructuring costs relating to the Bard acquisition. For further disclosures regarding the costs relating to restructurings, refer to Note 11 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Other operating expense, net Other operating expense in 2021, 2020 and 2019 included the following items which are further discussed in the Notes to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data: (Millions of dollars) 2021 2020 2019
Charges to record product liability reserves, including related defense costs (See Note 5)
$ 361 $ 378 $ 914 Gains on sale-leaseback transactions (See Note 17) (158) - - Separation and related costs (a) 35 - - Gain recognized on sale of Advanced Bioprocessing business (See Note 10) - - (336)
Charge to record the estimated cost of a product recall in the Medical segment
- - 75 Other - (15) - Other operating expense, net$ 238
(a)Represents costs incurred for consulting, legal, tax and other advisory services associated with the planned spin-off of BD's Diabetes Care business.
Net Interest Expense
(Millions of dollars) 2021 2020 2019 Interest expense$ (469) $ (528) $ (639) Interest income 9 7 12 Net interest expense$ (460) $ (521) $ (627) Lower interest expense in 2021 and 2020 compared with the prior-year periods reflected debt repayments and lower overall interest rates on debt outstanding during 2021 and 2020. Additional disclosures regarding our financing arrangements and debt instruments are provided in Note 15 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Income Taxes The income tax rates in 2021, 2020 and 2019 were as follows: 2021 2020 2019 Effective income tax rate 6.7 % 11.3 % (4.8) % Impact, in basis points, from specified items and tax reform (470) (320) (1,920) 36
-------------------------------------------------------------------------------- Table of Contents The effective income tax rate in 2021 reflected the impact of discrete tax items, as well as an impact from specified items in 2021 that was more favorable compared with the benefit associated with specified items in 2020. The impact from specified items in 2020 was less favorable compared with the benefit associated with specified items in 2019. The effective income tax rate in 2019 also reflected a favorable impact relating to the timing of certain discrete items, as well as the recognition of$50 million of tax benefit recorded for the impacts ofU.S. tax legislation that was enacted inDecember 2017 . For further disclosures regarding our accounting for thisU.S. tax legislation, refer to Note 16 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data.
Net Income and Diluted Earnings per Share Net Income and Diluted Earnings per Share in 2021, 2020 and 2019 were as follows:
2021
2020 2019
Net income (Millions of dollars)$ 2,092 $
874
Diluted Earnings per Share$ 6.85 $
2.71
Unfavorable impact-specified items$ (6.22) $
(7.49)
Unfavorable impact-foreign currency translation
Financial Instrument Market Risk We selectively use financial instruments to manage market risk, primarily foreign currency exchange risk and interest rate risk relating to our ongoing business operations. The counterparties to these contracts are highly rated financial institutions. We do not enter into financial instruments for trading or speculative purposes. Foreign Exchange Risk BD and its subsidiaries transact business in various foreign currencies throughoutEurope ,Greater Asia ,Canada andLatin America . We face foreign currency exposure from the effect of fluctuating exchange rates on payables and receivables relating to transactions that are denominated in currencies other than our functional currency. These payables and receivables primarily arise from intercompany transactions. We hedge substantially all such exposures, primarily through the use of forward contracts. We have also hedged the currency exposure associated with investments in certain foreign subsidiaries with instruments such as foreign currency-denominated debt and cross-currency swaps, which are designated as net investment hedges, as well as currency exchange contracts. We also face currency exposure that arises from translating the results of our worldwide operations, including sales, to theU.S. dollar at exchange rates that have fluctuated from the beginning of a reporting period. We did not enter into contracts to hedge cash flows against these foreign currency fluctuations in fiscal year 2021 or 2020. Derivative financial instruments are recorded on our balance sheet at fair value. For foreign currency derivatives, market risk is determined by calculating the impact on fair value of an assumed change in foreign exchange rates relative to theU.S. dollar. Fair values were estimated based upon observable inputs, specifically spot currency rates and foreign currency prices for similar assets and liabilities. With respect to the foreign currency derivative instruments outstanding atSeptember 30, 2021 and 2020, the impact that changes in theU.S. dollar would have on pre-tax earnings was estimated as follows: Increase (decrease) (Millions of dollars) 2021 2020 10% appreciation in U.S. dollar$ (66) $ (52) 10% depreciation in U.S. dollar$ 66 $ 52 37
-------------------------------------------------------------------------------- Table of Contents These calculations do not reflect the impact of exchange gains or losses on the underlying transactions that would substantially offset the results of the derivative instruments. Interest Rate Risk When managing interest rate exposures, we strive to achieve an appropriate balance between fixed and floating rate instruments. We may enter into interest rate swaps to help maintain this balance and manage debt and interest-bearing investments in tandem, since these items have an offsetting impact on interest rate exposure. For interest rate derivative instruments, fair values are measured based upon the present value of expected future cash flows using market-based observable inputs including credit risk and interest rate yield curves. Market risk for these instruments is determined by calculating the impact to fair value of an assumed change in interest rates across all maturities. The impact that changes in interest rates would have on interest rate derivatives outstanding atSeptember 30, 2021 and 2020, as well as the effect that changes in interest rates would have on our earnings or cash flows over a one-year period, based upon our overall interest rate exposure, were estimated as follows: Increase (decrease) to fair value of interest rate derivatives Increase (decrease) to earnings or outstanding cash flows (Millions of dollars) 2021 2020 2021 2020 10% increase in interest rates $ 7$ 13 $ - $ - 10% decrease in interest rates$ (7) $ (14) $ - $ - Liquidity and Capital Resources Our strong financial position and cash flow performance have provided us with the capacity to accelerate our innovation pipeline through investments in research and development, as well as through strategic acquisitions. We believe that our available cash and cash equivalents, our ability to generate operating cash flow, and if needed, our access to borrowings from our financing facilities provide us with sufficient liquidity to satisfy our foreseeable operating needs. The following table summarizes our consolidated statement of cash flows in 2021, 2020 and 2019: (Millions of dollars) 2021 2020 2019 Net cash provided by (used for) Operating activities$ 4,647 $ 3,539 $ 3,330 Investing activities$ (1,880) $ (1,232) $ (741) Financing activities$ (3,306) $ 22 $ (3,223) Net Cash Flows from Operating Activities Cash flows from operating activities in 2021 reflected higher net income, which was driven by strong revenue performance, adjusted by a change in operating assets and liabilities that was a net source of cash. This net source of cash primarily reflected higher levels of accounts payable and accrued expenses, partially offset by higher levels of prepaid expenses, inventory and trade receivables. Cash flows from operating activities in 2021 additionally reflected a$16 million discretionary cash contribution to fund our pension obligation. Cash flows from operating activities in 2020 reflected net income, adjusted by a change in operating assets and liabilities that was a net source of cash. This net source of cash primarily reflected higher levels of accounts payable and accrued expenses and lower levels of prepaid expenses, partially offset by higher levels of inventory and trade receivables. Cash flows from operating activities in 2019 reflected net income, adjusted by a change in operating assets and liabilities that was a net use of cash. This net use of cash primarily reflected lower levels of accounts 38 -------------------------------------------------------------------------------- Table of Contents payable and accrued expenses and higher levels of inventory, partially offset by lower levels of prepaid expenses. The lower levels of accounts payable and accrued expenses were primarily attributable to cash paid related to income taxes and our product liability matters, as well as the timing and amount of interest payments due in the period. Cash flows from operating activities in 2019 additionally reflected$200 million of discretionary cash contributions to fund our pension obligation. Net Cash Flows fromInvesting Activities Capital expenditures Our investments in capital expenditures are focused on projects that enhance our cost structure and manufacturing capabilities, and support our strategy of geographic expansion with select investments in growing markets. Capital expenditures of$1.231 billion ,$810 million and$957 million in 2021, 2020 and 2019, respectively, primarily related to manufacturing capacity expansions. Details of spending by segment are contained in Note 7 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Acquisitions Cash outflows for acquisitions in 2021 and 2020 included cash payments relating to various strategic acquisitions we have executed as part of our growth strategy, including our acquisition ofTepha, Inc. in the fourth quarter of 2021 and our acquisition ofStraub Medical AG in the third quarter of 2020. Divestitures Cash inflows relating to divestitures in 2019 were$477 million . For further discussion, refer to Note 10 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Net Cash Flows from Financing Activities Net cash from financing activities in 2021, 2020 and 2019 included the following significant cash flows: (Millions of dollars) 2021 2020 2019 Cash inflow (outflow) Change in credit facility borrowings $ - $
(485)
Proceeds from long-term debt and term loans
Payments of debt and term loans$ (5,112) $
(4,664)
Proceeds from issuances of equity securities $ -$ 2,917 $ - Share repurchases$ (1,750) $ - $ - Dividends paid$ (1,048) $ (1,026) $ (984) Additional disclosures regarding the equity and debt-related financing activities detailed above are provided in Notes 3 and 15 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. 39
-------------------------------------------------------------------------------- Table of Contents Debt-Related Activities
Certain measures relating to our total debt were as follows:
2021 2020
2019
Total debt (Millions of dollars)$ 17,610 $ 17,931
Short-term debt as a percentage of total debt 2.8 % 3.9 % 6.8 % Weighted average cost of total debt
2.4 % 2.8
% 2.9 % Total debt as a percentage of total capital (a) 41.0 % 41.3 % 45.6 %
(a) Represents shareholders' equity, net non-current deferred income tax liabilities, and debt.
The decreases in our total debt atSeptember 30, 2021 andSeptember 30, 2020 reflected repayments and redemptions of certain notes, partially offset by issuances of long-term notes in 2021 and 2020. Additional disclosures regarding our debt instruments are provided in Note 15 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Cash and Short-term Investments AtSeptember 30, 2021 , total worldwide cash and equivalents and short-term investments, including restricted cash, were$2.403 billion . These assets were largely held in jurisdictions outside ofthe United States . We regularly review the amount of cash and short-term investments held outside ofthe United States and our historical foreign earnings are used to fund foreign investments or meet foreign working capital and property, plant and equipment expenditure needs. To fund cash needs inthe United States , we rely on ongoing cash flow fromU.S. operations, access to capital markets and remittances from foreign subsidiaries of earnings that are not considered to be permanently reinvested. Financing Facilities During the fourth quarter of fiscal year 2021, the Company refinanced its five-year senior unsecured revolving credit facility that was to expire inDecember 2022 , with a new five-year senior unsecured revolving credit facility that will expire inSeptember 2026 . The credit facility provides borrowings of up to$2.75 billion , with separate sub-limits of$100 million for letters of credit and swingline loans. The expiration date of the credit facility may be extended for up to two additional one year periods, subject to certain restrictions (including the consent of the lenders). The credit facility provides that we may, subject to additional commitments by lenders, request an additional$500 million of financing, for a maximum aggregate commitment under the credit facility of up to$3.25 billion . Proceeds from this facility may be used for general corporate purposes. There were no borrowings outstanding under the revolving credit facility atSeptember 30, 2021 . The agreement for our revolving credit facility contains the following financial covenants. We were in compliance with these covenants, as applicable, as ofSeptember 30, 2021 . •We are required to have a leverage coverage ratio of no more than: •4.25-to-1 as of the last day of each fiscal quarter following the closing of the credit facility; or •4.75-to-1 for the four full fiscal quarters following the consummation of a material acquisition. We also have informal lines of credit outsidethe United States . We may, from time to time, access the commercial paper market as we manage working capital over the normal course of our business activities. We had no commercial paper borrowings outstanding as ofSeptember 30, 2021 . Also, over the normal course of our business activities, we transfer certain trade receivable assets to third parties under factoring agreements. Additional disclosures regarding sales of trade receivable assets are provided in Note 14 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. 40
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Access to Capital and Credit Ratings Our corporate credit ratings with the rating agenciesStandard & Poor's Ratings Services ("S&P"), Moody's Investor Service ("Moody's") and Fitch Ratings ("Fitch") were as follows atSeptember 30, 2021 : S&P Moody's Fitch Ratings: Senior Unsecured Debt BBB Baa3 BBB- Commercial Paper A-2 P-3 Outlook Stable Positive Positive InJanuary 2021 , S&P affirmed ourSeptember 30, 2020 ratings and revised the agency's outlook on our ratings to Stable from Negative. Also inJanuary 2021 , Moody's upgraded our senior unsecured rating to Baa3 from Ba1, as well as our commercial paper rating to P-3 from NP. Moody's also affirmed its positive outlook on our ratings. InMay 2021 , Fitch affirmed ourSeptember 30, 2020 rating and revised its outlook on our ratings from Stable to Positive. Lower corporate debt ratings and downgrades of our corporate credit ratings or other credit ratings may increase our cost of borrowing. We believe that given our debt ratings, our financial management policies, our ability to generate cash flow and the non-cyclical, geographically diversified nature of our businesses, we would have access to additional short-term and long-term capital should the need arise. A rating reflects only the view of a rating agency and is not a recommendation to buy, sell or hold securities. Ratings can be revised upward or downward at any time by a rating agency if such rating agency decides that circumstances warrant such a change. Contractual Obligations In the normal course of business, we enter into contracts and commitments that obligate us to make payments in the future. Information regarding our obligations under purchase, debt and lease arrangements are provided in Notes 5, 15 and 17, respectively, to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Critical Accounting Policies The following discussion supplements the descriptions of our accounting policies contained in Note 1 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. The preparation of the consolidated financial statements requires management to use estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, as well as the disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Some of those judgments can be subjective and complex and, consequently, actual results could differ from those estimates. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. For any given estimate or assumption made by management, it is possible that other people applying reasonable judgment to the same facts and circumstances could develop different estimates. Actual results that differ from management's estimates could have an unfavorable effect on our consolidated financial statements. Management believes the following critical accounting policies reflect the more significant judgments and estimates used in the preparation of the consolidated financial statements: Revenue Recognition Our revenues are primarily recognized when the customer obtains control of the product sold, which is generally upon shipment or delivery, depending on the delivery terms specified in the sales agreement. 41 -------------------------------------------------------------------------------- Table of Contents Revenues associated with certain instruments and equipment for which installation is complex, and therefore significantly affects the customer's ability to use and benefit from the product, are recognized when customer acceptance of these installed products has been confirmed. For certain service arrangements, including extended warranty and software maintenance contracts, revenue is recognized ratably over the contract term. The majority of revenues relating to extended warranty contracts associated with certain instruments and equipment is generally recognized within a few years whereas deferred revenue relating to software maintenance contracts is generally recognized over a longer period. Our agreements with customers within certain organizational units including Medication Management Solutions, Integrated Diagnostic Solutions and Biosciences, contain multiple performance obligations including both products and certain services noted above. Determining whether products and services are considered distinct performance obligations that should be accounted for separately may require judgment. The transaction price for these agreements is allocated to each performance obligation based upon its relative standalone selling price. Standalone selling price is the amount at which we would sell a promised good or service separately to a customer. We generally estimate standalone selling prices using list prices and a consideration of typical discounts offered to customers. The use of alternative estimates could result in a different amount of revenue deferral. Our gross revenues are subject to a variety of deductions, which include rebates and sales discounts. These deductions represent estimates of the related obligations and judgment is required when determining the impact on gross revenues for a reporting period. Additional factors considered in the estimate of our rebate liability include the quantification of inventory that is either in stock at or in transit to our distributors, as well as the estimated lag time between the sale of product and the payment of corresponding rebates. Impairment of AssetsGoodwill assets are subject to impairment reviews at least annually, or whenever indicators of impairment arise. Intangible assets with finite lives, including developed technology, and other long-lived assets, are periodically reviewed for impairment when impairment indicators are present. We assess goodwill for impairment at the reporting unit level, which is defined as an operating segment or one level below an operating segment, referred to as a component. Our reporting units generally represent one level below reporting segments. Our review of goodwill for each reporting unit compares the fair value of the reporting unit, estimated using an income approach, with its carrying value. Our annual goodwill impairment test performed onJuly 1, 2021 did not result in any impairment charges, as the fair value of each reporting unit exceeded its carrying value. We generally use the income approach to derive the fair value for impairment assessments. This approach calculates fair value by estimating future cash flows attributable to the assets and then discounting these cash flows to a present value using a risk-adjusted discount rate. We selected this method because we believe the income approach most appropriately measures the value of our income producing assets. This approach requires significant management judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, appropriate discount rates, terminal values and other assumptions and estimates. The estimates and assumptions used are consistent with BD's business plans. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of the asset. Actual results may differ from management's estimates. Income Taxes BD maintains valuation allowances where it is more likely than not that all or a portion of a deferred tax asset will not be realized. Changes in valuation allowances are included in our tax provision in the period of change. In determining whether a valuation allowance is warranted, management evaluates factors such as prior earnings history, expected future earnings, carry back and carry forward periods, and tax strategies that could potentially enhance the likelihood of realization of a deferred tax asset. BD conducts business and files tax returns in numerous countries and currently has tax audits in progress in a number of tax jurisdictions. In evaluating the exposure associated with various tax filing positions, we 42 -------------------------------------------------------------------------------- Table of Contents record accruals for uncertain tax positions based on the technical support for the positions, our past audit experience with similar situations, and the potential interest and penalties related to the matters. BD's effective tax rate in any given period could be impacted if, upon resolution with taxing authorities, we prevailed in positions for which reserves have been established, or we were required to pay amounts in excess of established reserves. We have reviewed our needs inthe United States for possible repatriation of undistributed earnings of our foreign subsidiaries and we continue to invest foreign subsidiaries earnings outside ofthe United States to fund foreign investments or meet foreign working capital and property, plant and equipment expenditure needs. As a result, we are permanently reinvested with respect to all of our historical foreign earnings as ofSeptember 30, 2021 . Additional disclosures regarding our accounting for income taxes are provided in Note 16 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. Contingencies We are involved, both as a plaintiff and a defendant, in various legal proceedings that arise in the ordinary course of business, including, without limitation, product liability and environmental matters, as further discussed in Note 5 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. We assess the likelihood of any adverse judgments or outcomes to these matters as well as potential ranges of probable losses. We establish accruals to the extent probable future losses are estimable (in the case of environmental matters, without considering possible third-party recoveries). A determination of the amount of accruals for these contingencies is made after careful analysis of each individual matter. When appropriate, the accrual is developed with the consultation of outside counsel and, as in the case of certain mass tort litigation, the expertise of an actuarial specialist regarding the nature, timing and extent of each matter. The accruals may change in the future due to new developments in each matter or changes in our litigation strategy. We record expected recoveries from product liability insurance carriers or other parties when realization of recovery is deemed probable. Given the uncertain nature of litigation generally, we are not able in all cases to estimate the amount or range of loss that could result from an unfavorable outcome of the litigation to which we are a party. In view of these uncertainties, we could incur charges in excess of any currently established accruals and, to the extent available, liability insurance. In the opinion of management, any such future charges, individually or in the aggregate, could have a material adverse effect on BD's consolidated results of operations and consolidated net cash flows. Benefit Plans We have significant net pension and other postretirement and postemployment benefit obligations that are measured using actuarial valuations which include assumptions for the discount rate and the expected return on plan assets. These assumptions have a significant effect on the amounts reported. In addition to the analysis below, see Note 9 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data for additional discussion. The discount rate is selected each year based on investment grade bonds and other factors as of the measurement date (September 30 ). Specifically for theU.S. pension plan, we will use a discount rate of 2.89% for 2022, which was based on an actuarially-determined, company-specific yield curve to measure liabilities as of the measurement date. To calculate the pension expense in 2022, we will apply the individual spot rates along the yield curve that correspond with the timing of each future cash outflow for benefit payments in order to calculate interest cost and service cost. Additional disclosures regarding the method to be used in calculating the interest cost and service cost components of pension expense for 2022 are provided in Note 9 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data. The expected long-term rate of return on plan assets assumption, although reviewed each year, changes less frequently due to the long-term nature of the assumption. This assumption does not impact the measurement of assets or liabilities as of the measurement date; rather, it is used only in the calculation of pension expense. To determine the expected long-term rate of return on pension plan assets, we consider many factors, including our historical assumptions compared with actual results; benchmark data; expected returns on various plan asset 43 -------------------------------------------------------------------------------- Table of Contents classes, as well as current and expected asset allocations. We will use a long-term expected rate of return on plan assets assumption of 6.25% for theU.S. pension plan in 2022. We believe our discount rate and expected long-term rate of return on plan assets assumptions are appropriate based upon the above factors. Sensitivity to changes in key assumptions for ourU.S. pension and other postretirement and postemployment plans are as follows: •Discount rate - A change of plus (minus) 25 basis points, with other assumptions held constant, would have an estimated$6 million favorable (unfavorable) impact on the totalU.S. net pension and other postretirement and postemployment benefit plan costs. This estimate assumes no change in the shape or steepness of the company-specific yield curve used to plot the individual spot rates that will be applied to the future cash outflows for future benefit payments in order to calculate interest and service cost. •Expected return on plan assets - A change of plus (minus) 25 basis points, with other assumptions held constant, would have an estimated$5 million favorable (unfavorable) impact onU.S. pension plan costs. Cautionary Statement Regarding Forward-Looking Statements This report includes forward-looking statements within the meaning of the federal securities laws. BD and its representatives may also, from time to time, make certain forward-looking statements in publicly released materials, both written and oral, including statements contained in filings with theSecurities and Exchange Commission , press releases, and our reports to shareholders. Forward-looking statements may be identified by the use of words such as "plan," "expect," "believe," "intend," "will," "may," "anticipate," "estimate" and other words of similar meaning in conjunction with, among other things, discussions of future operations and financial performance (including volume growth, pricing, sales and earnings per share growth, and cash flows) and statements regarding our strategy for growth, future product development, regulatory approvals, competitive position and expenditures. All statements that address our future operating performance or events or developments that we expect or anticipate will occur in the future are forward-looking statements. Forward-looking statements are, and will be, based on management's then-current views and assumptions regarding future events, developments and operating performance, and speak only as of their dates. Investors should realize that if underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results could vary materially from our expectations and projections. Investors are therefore cautioned not to place undue reliance on any forward-looking statements. Furthermore, we undertake no obligation to update or revise any forward-looking statements after the date they are made, whether as a result of new information, future events and developments or otherwise, except as required by applicable law or regulations. The following are some important factors that could cause our actual results to differ from our expectations in any forward-looking statements. For further discussion of certain of these factors, see Item 1A. Risk Factors in this report. •Any impact of the COVID-19 pandemic on our business, including, without limitation, decreases in the demand for our products or disruptions to our operations or our supply chain, and factors such as the rate of vaccination, the rate of infections and competitive factors could impact the demand and pricing for our COVID-19 diagnostics testing. •Weakness in the global economy and financial markets, which could increase the cost of operating our business, weaken demand for our products and services, negatively impact the prices we can charge for our products and services, or impair our ability to produce our products. •The risks associated with the proposed spin-off of our Diabetes Care business, including factors that could delay, prevent or otherwise adversely affect the completion, timing or terms of the spin-off, our ability to realize the expected benefits of the spin-off, or the qualification of the spin-off as a tax-free transaction forU.S. federal income tax purposes. 44 -------------------------------------------------------------------------------- Table of Contents •Competitive factors that could adversely affect our operations, including new product introductions and technologies (for example, new forms of drug delivery) by our current or future competitors, consolidation or strategic alliances among healthcare companies, distributors and/or payers of healthcare to improve their competitive position or develop new models for the delivery of healthcare, increased pricing pressure due to the impact of low-cost manufacturers, patents attained by competitors (particularly as patents on our products expire), new entrants into our markets and changes in the practice of medicine. •Risks relating to our overall level of indebtedness, including our ability to service our debt and refinance our indebtedness, which is dependent upon the capital markets and our overall financial condition at such time. •The adverse financial impact resulting from unfavorable changes in foreign currency exchange rates. •Regional, national and foreign economic factors, including inflation, deflation and fluctuations in interest rates, and their potential effect on our operating performance. •Our ability to achieve our projected level or mix of product sales, as our earnings forecasts are based on projected sales volumes and pricing of many product types, some of which are more profitable than others. •Changes in reimbursement practices of governments or third-party payers, or adverse decisions relating to our products by such payers, which could reduce demand for our products or the price we can charge for such products. •Cost containment efforts in theU.S. or in other countries in which we do business, such as alternative payment reform and increased use of competitive bidding and tenders, including, without limitation, any expansion of the volume-based procurement process inChina . •Changes in the domestic and foreign healthcare industry or in medical practices that result in a reduction in procedures using our products or increased pricing pressures, including cost reduction measures instituted by and the continued consolidation among healthcare providers. •The impact of changes inU.S. federal laws and policies that could affect fiscal and tax policies, healthcare and international trade, including import and export regulation and international trade agreements. In particular, tariffs or other trade barriers imposed by theU.S. or other countries could adversely impact our supply chain costs or otherwise adversely impact our results of operations. •Increases in operating costs, including fluctuations in the cost and availability of oil-based resins and other raw materials, as well as certain components, used in our products, including any disruptions in the global supply chain of raw materials and components, inflationary pricing pressure, labor shortages or increased labor costs, the ability to maintain favorable supplier and service arrangements and relationships (particularly with respect to sole-source suppliers and sterilization services), and the potential adverse effects of any disruption in the availability of such items and services. •Security breaches of our information systems or our products, which could impair our ability to conduct business, result in the loss of BD trade secrets or otherwise compromise sensitive information of BD or its customers, suppliers and other business partners, or of customers' patients, including sensitive personal data, or result in product efficacy or safety concerns for certain of our products, and result in actions by regulatory bodies or civil litigation. •Difficulties inherent in product development, including the potential inability to successfully continue technological innovation, successfully complete clinical trials, obtain and maintain regulatory approvals and registrations inthe United States and abroad, obtain intellectual property protection for our products, obtain coverage and adequate reimbursement for new products, or gain and maintain market approval of products, as well as the possibility of infringement claims by competitors with respect to patents or other intellectual property rights, all of which can preclude or delay commercialization of a product. Delays in 45 -------------------------------------------------------------------------------- Table of Contents obtaining necessary approvals or clearances from the FDA or other regulatory agencies or changes in the regulatory process may also delay product launches and increase development costs. •The impact of business combinations or divestitures, including any volatility in earnings relating to acquisition-related costs, and our ability to successfully integrate any business we may acquire. •Our ability to penetrate or expand our operations in emerging markets, which depends on local economic and political conditions, and how well we are able to make necessary infrastructure enhancements to production facilities and distribution networks. •Conditions in international markets, including social and political conditions, civil unrest, terrorist activity, governmental changes, restrictions on the ability to transfer capital across borders, tariffs and other protectionist measures, difficulties in protecting and enforcing our intellectual property rights and governmental expropriation of assets. Our international operations also increase our compliance risks, including risks under the Foreign Corrupt Practices Act and other anti-corruption laws, as well as regulatory and privacy laws. •Deficit reduction efforts or other actions that reduce the availability of government funding for healthcare and research, which could weaken demand for our products and result in additional pricing pressures, as well as create potential collection risks associated with such sales. •Fluctuations in university orU.S. and international governmental funding and policies for life sciences research. •Fluctuations in the demand for products we sell to pharmaceutical companies that are used to manufacture, or are sold with, the products of such companies, as a result of funding constraints, consolidation or otherwise. •The effects of climate change, weather, regulatory or other events that adversely impact our supply chain, including our ability to manufacture our products (particularly where production of a product line or sterilization operations are concentrated in one or more plants), source materials or components or services from suppliers (including sole-source suppliers) that are needed for such manufacturing (including sterilization), or provide products to our customers, including events that impact key distributors. •Natural disasters, including the impacts of climate change, hurricanes, tornadoes, windstorms, fires, earthquakes and floods and other extreme weather events, global health pandemics, war, terrorism, labor disruptions and international conflicts that could cause significant economic disruption and political and social instability, resulting in decreased demand for our products, or adversely affecting our manufacturing and distribution capabilities or causing interruptions in our supply chain. •Pending and potential future litigation or other proceedings asserting, and/or investigations concerning and/or subpoenas and requests seeking information with respect to, alleged violations of law (including in connection with federal and/or state healthcare programs (such as Medicare or Medicaid) and/or sales and marketing practices (such as investigative subpoenas and the civil investigative demands received by BD)), potential anti-corruption and related internal control violations under the Foreign Corrupt Practices Act, antitrust claims, securities law claims, product liability (which may involve lawsuits seeking class action status or seeking to establish multi-district litigation proceedings, including pending claims relating to our hernia repair implant products, surgical continence products for women and vena cava filter products), claims with respect to environmental matters, data privacy breaches and patent infringement, and the availability or collectability of insurance relating to any such claims. •New or changing laws and regulations affecting our domestic and foreign operations, or changes in enforcement practices, including laws relating to trade, monetary and fiscal policies, taxation (including tax reforms that could adversely impact multinational corporations), sales practices, environmental protection, price controls, and licensing and regulatory requirements for new products and products in the post-marketing phase. In particular, theU.S. and other countries may impose new requirements 46 -------------------------------------------------------------------------------- Table of Contents regarding registration, labeling or prohibited materials that may require us to re-register products already on the market or otherwise impact our ability to market our products. Environmental laws, particularly with respect to the emission of greenhouse gases, are also becoming more stringent throughout the world, which may increase our costs of operations or necessitate changes in our manufacturing plants or processes or those of our suppliers, or result in liability to BD. •Product efficacy or safety concerns regarding our products resulting in product holds or recalls, regulatory action on the part of the FDA or foreign counterparts (including restrictions on future product clearances and civil penalties), declining sales and product liability claims, and damage to our reputation. As a result of theCareFusion acquisition, ourU.S. infusion pump business is operating under a Consent Decree with the FDA. The Consent Decree authorizes the FDA, in the event of any violations in the future, to order ourU.S. infusion pump business to cease manufacturing and distributing products, recall products or take other actions, and order the payment of significant monetary damages if the business subject to the decree fails to comply with any provision of the Consent Decree. We are undertaking certain remediation of our BD AlarisTM System, and are currently shipping the product in theU.S. , only in cases of medical necessity and to remediate recalled software versions. We will not be able to fully resume commercial operations for the BD Alaris System in theU.S. until a 510(k) submission relating to the product has been cleared by the FDA. No assurances can be given as to when or if clearance will be obtained from the FDA. •The effect of adverse media exposure or other publicity regarding BD's business or operations, including the effect on BD's reputation or demand for its products. •The effect of market fluctuations on the value of assets in BD's pension plans and on actuarial interest rate and asset return assumptions, which could require BD to make additional contributions to the plans or increase our pension plan expense. •Our ability to obtain the anticipated benefits of restructuring programs, if any, that we may undertake. •Issuance of new or revised accounting standards by the FASB or theSEC . The foregoing list sets forth many, but not all, of the factors that could impact our ability to achieve results described in any forward-looking statements. Investors should understand that it is not possible to predict or identify all such factors and should not consider this list to be a complete statement of all potential risks and uncertainties. Item 7A. Quantitative and Qualitative Disclosures About Market Risk. The information required by this item is included in Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations, and in Notes 1, 14 and 15 to the consolidated financial statements contained in Item 8. Financial Statements and Supplementary Data, and is incorporated herein by reference. 47
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