BD - Becton, Dickinson and Company
02/09/2026 | Press release | Distributed by Public on 02/09/2026 15:20
Quarterly Report for Quarter Ending December 31, 2025 (Form 10-Q)
Management's Discussion and Analysis of Financial Condition and Results of Operations
The following commentary should be read in conjunction with the condensed consolidated financial statements and accompanying notes presented in this report. Within the tables presented throughout this discussion, certain columns may not add due to the use of rounded numbers for disclosure purposes. Percentages and earnings per share amounts presented are calculated from the underlying amounts. References to years throughout this discussion relate to our fiscal years, which end on September 30.
Company Overview
Becton, Dickinson and Company ("BD") is a global medical technology company engaged in the development, manufacture and sale of a broad range of medical supplies, devices, laboratory equipment and diagnostic products used by healthcare institutions, physicians, life science researchers, clinical laboratories, the pharmaceutical industry and the general public.
Effective October 1, 2025, we reorganized our organizational units into five distinct, separately-managed segments, based on the nature of our product and service offerings. Our new organizational structure is based upon the following five worldwide segments: BD Medical Essentials ("Medical Essentials"), BD Connected Care ("Connected Care"), BD BioPharma Systems ("BioPharma Systems"), BD Interventional ("Interventional") and BD Life Sciences ("Life Sciences"). Our prior-period segment amounts have been recast in the tables below to conform to the new segment structure and to the current-period segment income presentation, as further discussed in Note 7 in the Condensed Consolidated Financial Statements.
The Life Sciences segment includes our Biosciences and Diagnostic Solutions business, which was separated from BD and combined with Waters Corporation ("Waters") on February 9, 2026, as further discussed in Note 1 to the Condensed Consolidated Financial Statements. Subsequent to the separation and combination, the historical results of the Biosciences and Diagnostic Solutions business will be reflected as discontinued operations in our consolidated financial statements and the Life Sciences segment will be eliminated from our segment reporting, which will consist of the remaining four reportable segments.
BD's products are manufactured and sold worldwide. Our products are marketed in the United States and internationally through independent distribution channels and directly to end-users by BD and independent sales representatives. Beginning in fiscal 2026, we split our EMEA (Europe, the Middle East and Africa) region into two distinct regions, Europe and META (the Middle East, Turkey, and Africa), to better align with our organizational structure. We now organize our operations outside the United States as follows: Europe, META; Greater Asia (which includes countries in Greater China, Japan, South Asia, Southeast Asia, Korea, Australia and New Zealand); Latin America (which includes Mexico, Central America, the Caribbean and South America); and Canada. We continue to pursue growth opportunities in emerging markets, which include the following geographic regions: Eastern Europe, the Middle East and Africa, Latin America and certain countries within Greater Asia.
As discussed above, we have reorganized our businesses and entered a new strategy of growth across our segments. Under New BD, we remain focused on touching and improving more patient lives, creating greater value for our associates and delivering even more impact for our customers. Our New BD strategy, Excellence Unleashed, is anchored in three strategic priorities: "compete", "innovate" and "deliver". To "compete", we are elevating our commercial capabilities to gain share in the fastest growing areas of the medical technology market and to deliver an exceptional customer experience. Our priority to "innovate" emphasizes bringing high-impact solutions to the market and executing a pipeline that is stronger, more focused and productivity-driven. As we "deliver", we strive for operational excellence, particularly in areas including safety, quality, reliable supply and cash flow generation.
Key Trends and Uncertainties Affecting Results of Operations
Our operations, supply chain, suppliers and customers are exposed to various global macroeconomic factors and other risks which we continually evaluate to assess their potential impact to our operations and financial results.
We have been experiencing, and may continue to experience, some adverse impact to our results of operations due to market dynamics in China, such as volume-based procurement programs ("VoBP") and the government's focus to improve compliance of healthcare practitioners. Also, reductions or delays in governmental research funding has caused customers for certain of our instruments to delay or forgo purchases of these products. Lower demand for vaccines has also adversely impacted our results of operations. The future demand for our products and services could be impacted by other factors including the deterioration of healthcare systems' budgets.
In general, major disruptions in the sourcing, manufacturing and distribution of our products could adversely impact our results of operations. Also, tariffs, sanctions or other trade barriers imposed by the United States, or against the United States from countries in which we do business, could adversely impact our supply chain costs, results of operations and our financial condition. Tariffs adversely impacted our first quarter fiscal year 2026 operating expense and we continue to monitor
international trade policy-related developments to assess their potential future impacts to our operations. Based upon the latest published tariffs that are currently in effect, we expect a continued adverse impact to operating expense for fiscal year 2026 and potentially beyond, primarily relating to any products (or components) imported from countries across our global supply chain which have no exemption opportunities. The ultimate impact of any existing or new tariffs or other changes in international trade policies is subject to a number of factors including, but not limited to, the duration of such tariffs, changes in tariff rates, the amount, scope and nature of the tariffs, any countermeasures that target countries may take, or any mitigating actions that may become available. While sourcing optimization and tariff exemptions for qualifying products are key aspects of our mitigation strategy, the timing of such or the ultimate results we will realize from these efforts are uncertain. In addition, our tariff mitigation strategies have been, and may be further challenged, rejected or eliminated through legislation or other challenges, or may otherwise not be effective, which may impact the collectability of the receivable we have recorded for exemption claims.
We continue to invest in research and development, strategic tuck-in acquisitions, geographic expansion, and new product programs to drive further revenue and profit growth. Our ability to sustain our long-term growth will depend on a number of factors, including our ability to expand our core business (including strategic geographical expansion), and develop innovative new products, as well as continue to improve operating efficiency and organizational effectiveness.
For additional information on risk factors that may impact our business, results of operations, financial condition and cash flows, see Part I, Item 1A. Risk Factors of our 2025 Annual Report on Form 10-K (the "2025 Annual Report").
Overview of Financial Results and Financial Condition
For the three months ended December 31, 2025, worldwide revenues of $5.252 billion increased 1.6% from the prior-year period. This increase reflected the following impacts:
| Increase (decrease) in current-period revenues | |||||
| Volume/other (a) | 0.3 | % | |||
| Pricing | 0.1 | % | |||
| Foreign currency impact | 1.2 | % | |||
|
Increase in revenues from the prior-year period
|
1.6 | % | |||
(a)Volume/other includes revenues attributable to products, services and licensing.
Cash flows from operating activities were $657 million in the first three months of fiscal year 2026. At December 31, 2025, we had $1.035 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 the first three months of fiscal year 2026, we paid cash dividends to common shareholders of $299 million. We also repurchased approximately $250 million of our common stock during the period. We expect to use approximately $2 billion of the cash distribution received in connection with the transaction with Waters, as further discussed in Note 1 in the Notes to Condensed Consolidated Financial Statements, for share repurchases through an accelerated share repurchase program that is expected to be executed in the second quarter of fiscal year 2026. The remainder of the cash distribution received from the transaction is expected to be used for debt repayments.
Each reporting period and given our worldwide operations, we face exposure to our results of operations from changes in foreign currencies. We calculate translational foreign currency impacts by converting our current-period local currency financial results using the prior-period foreign currency exchange rates and comparing these adjusted amounts to our current-period results, which allows us to compare results between periods as if exchange rates had remained constant period-over-period. The first quarter fiscal year 2026 impact of foreign currency on our revenues, which is primarily translational, is provided above. The translational impact on our earnings is provided further below. We evaluate our results of operations on both a reported and a foreign currency-neutral basis. As exchange rates are an important factor in understanding period-to-period comparisons, we believe the presentation of results on a foreign currency-neutral basis, excluding translational foreign currency impacts, in addition to reported results helps improve investors' ability to understand our operating results and evaluate our performance in comparison to prior periods. We use results on a foreign currency-neutral basis as one measure to evaluate our performance. These results should be considered in addition to, not as a substitute for, results reported in accordance with U.S. generally accepted accounting principles ("GAAP"). Results on a foreign currency-neutral basis, as we present them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with U.S. GAAP.
Results of Operations
Medical Essentials Segment
The following summarizes first quarter Medical Essentials revenues by organizational unit:
| Three months ended December 31, | |||||||||||||||||||||||||||||
| (Millions of dollars) | 2025 | 2024 |
Total Change |
Estimated FX Impact |
FXN Change | ||||||||||||||||||||||||
| Medication Delivery Solutions | $ | 1,128 | $ | 1,124 | 0.3 | % | 1.0 | % | (0.7) | % | |||||||||||||||||||
| Specimen Management | 468 | 462 | 1.3 | % | 1.6 | % | (0.3) | % | |||||||||||||||||||||
| Total Medical Essentials Revenues | $ | 1,595 | $ | 1,586 | 0.6 | % | 1.2 | % | (0.6) | % | |||||||||||||||||||
The Medical Essentials segment's revenues in the first quarter of 2026 primarily reflected declines in both organizational units due to VoBP impacts in China and an unfavorable prior-year comparison in the U.S. Medication Delivery Solutions unit, which were partially offset by the following:
•Market share gains achieved by the Medication Delivery Solutions unit's Vascular Access Management portfolio.
•Growth in the Specimen Management unit's BD VacutainerTMportfolio.
The Medical Essentials segment's income for the three-month periods is provided below.
| Three months ended December 31, | |||||||||||
| (Millions of dollars) | 2025 | 2024 | |||||||||
| Medical Essentials segment income | $ | 569 | $ | 607 | |||||||
| Segment income as % of Medical Essentials revenues | 35.6 | % | 38.3 | % | |||||||
The Medical Essentials segment's operating income as a percentage of revenues in the first quarter of 2026 compared with the first quarter of 2025 reflected the following:
•Lower gross profit margin in the first quarter of 2026 compared with the first quarter of 2025 primarily reflected higher labor costs and unfavorable impacts from tariffs and foreign currency translation, partially offset by lower manufacturing costs, which resulted from continuous improvement projects, supply chain optimization and other productivity initiatives.
•Higher selling and administrative expense as a percentage of revenues in the first quarter of 2026 compared with the first quarter of 2025 primarily reflected higher selling costs.
•Research and development expense as a percentage of revenues in the first quarter of 2026 was flat compared with the first quarter of 2025 which primarily reflected the timing of project spending.
Connected Care Segment
The following summarizes first quarter Connected Care revenues by organizational unit:
| Three months ended December 31, | |||||||||||||||||||||||||||||
| (Millions of dollars) | 2025 | 2024 |
Total Change |
Estimated FX Impact |
FXN Change | ||||||||||||||||||||||||
| Medication Management Solutions | $ | 835 | $ | 801 | 4.1 | % | 0.7 | % | 3.4 | % | |||||||||||||||||||
| Advanced Patient Monitoring | 297 | 271 | 9.4 | % | 0.6 | % | 8.8 | % | |||||||||||||||||||||
| Total Connected Care Revenues | $ | 1,131 | $ | 1,073 | 5.5 | % | 0.8 | % | 4.7 | % | |||||||||||||||||||
The Connected Care segment's revenue growth in the first quarter of 2026 primarily reflected the following:
•Growth within the Medication Management Solutions unit which was driven by Pharmacy Automation, primarily BD RowaTM, and strength in sales of infusion sets.
•Strong volume growth across the Advanced Patient Monitoring unit's portfolio.
The Connected Care segment's income for the three-month periods is provided below.
| Three months ended December 31, | |||||||||||
| (Millions of dollars) | 2025 | 2024 | |||||||||
| Connected Care segment income | $ | 352 | $ | 336 | |||||||
| Segment income as % of Connected Care revenues | 31.1 | % | 31.3 | % | |||||||
The Connected Care segment's operating income as a percentage of revenues in the first quarter of 2026 compared with the first quarter of 2025 reflected the following:
•Higher gross profit margin in the first quarter of 2026 compared with the first quarter of 2025 primarily reflected lower manufacturing costs, which resulted from continuous improvement projects, supply chain optimization and other productivity initiatives, as well as favorable product mix, partially offset by an unfavorable impact from tariffs.
•Higher selling and administrative expense as a percentage of revenues in the first quarter of 2026 compared with the first quarter of 2025 primarily reflected higher shipping, general and administrative and selling costs.
•Research and development expense as a percentage of revenues in the first quarter of 2026 was flat compared with the first quarter of 2025, which primarily reflected the timing of project spending.
BioPharma Systems Segment
The following summarizes first quarter BioPharma Systems revenues:
| Three months ended December 31, | |||||||||||||||||||||||||||||
| (Millions of dollars) | 2025 | 2024 |
Total Change |
Estimated FX Impact |
FXN Change | ||||||||||||||||||||||||
| BioPharma Systems Revenues | $ | 429 | $ | 418 | 2.7 | % | 1.7 | % | 1.0 | % | |||||||||||||||||||
The BioPharma Systems segment's revenues in the first quarter of 2026 were primarily driven by double-digit U.S. growth of prefillable solutions in the biologic drug category, led by sales of GLP-1 delivery products, partially offset by lower market demand for vaccines products.
The BioPharma Systems segment's income for the three-month periods is provided below.
| Three months ended December 31, | |||||||||||
| (Millions of dollars) | 2025 | 2024 | |||||||||
| BioPharma Systems segment income | $ | 140 | $ | 141 | |||||||
| Segment income as % of BioPharma Systems revenues | 32.6 | % | 33.7 | % | |||||||
The BioPharma Systems segment's operating income as a percentage of revenues in the first quarter of 2026 compared with the first quarter of 2025 reflected the following:
•Lower gross profit margin in the first quarter of 2026 compared with the first quarter of 2025 primarily reflected unfavorable impacts from tariffs as well as higher labor costs, partially offset by lower manufacturing costs, which resulted from continuous improvement projects, supply chain optimization and other productivity initiatives.
•Selling and administrative expense as a percentage of revenues in the first quarter of 2026 was flat compared with the first quarter of 2025, which primarily reflected favorable impacts from cost containment measures.
•Research and development expense as a percentage of revenues in the first quarter of 2026 was flat compared with the first quarter of 2025, which primarily reflected the timing of project spending.
Interventional Segment
The following summarizes first quarter Interventional revenues by organizational unit:
| Three months ended December 31, | |||||||||||||||||||||||||||||
| (Millions of dollars) | 2025 | 2024 |
Total Change |
Estimated FX Impact |
FXN Change | ||||||||||||||||||||||||
| Peripheral Intervention | $ | 485 | $ | 473 | 2.6 | % | 1.2 | % | 1.4 | % | |||||||||||||||||||
| Urology and Critical Care | 427 | 389 | 9.8 | % | 0.3 | % | 9.5 | % | |||||||||||||||||||||
| Surgery | 418 | 395 | 5.9 | % | 0.8 | % | 5.1 | % | |||||||||||||||||||||
| Total Interventional Revenues | $ | 1,330 | $ | 1,257 | 5.8 | % | 0.7 | % | 5.1 | % | |||||||||||||||||||
The Interventional segment's revenue growth in the first quarter of 2026 primarily reflected the following:
•Strong sales growth in the Peripheral Intervention unit's oncology products in the U.S. and continued growth in sales of the RotarexTMAtherectomy System, partially offset by a VoBP impact in China.
•Double-digit growth in sales of the Urology and Critical Care unit's PureWickTM offerings.
•Double-digit growth in sales of the Surgery unit's advanced tissue regeneration portfolio, as well as high single-digit growth attributable to the unit's infection prevention products.
Interventional segment income for the three-month periods is provided below.
| Three months ended December 31, | |||||||||||
| (Millions of dollars) | 2025 | 2024 | |||||||||
| Interventional segment income | $ | 561 | $ | 561 | |||||||
| Segment income as % of Interventional revenues | 42.1 | % | 44.6 | % | |||||||
The Interventional segment's operating income as a percentage of revenues in the first quarter of 2026 compared with the first quarter of 2025 reflected the following:
•Gross profit margin in the first quarter of 2026 was lower compared with the first quarter of 2025, which primarily reflected unfavorable impacts from tariffs as well as higher labor costs, partially offset by lower manufacturing costs resulting from continuous improvement projects, supply chain optimization and other productivity initiatives.
•Higher selling and administrative expense as a percentage of revenues in the first quarter of 2026 compared with the first quarter of 2025 primarily reflected higher selling costs from an increased investment in growth-accelerating initiatives.
•Research and development expense as a percentage of revenues in the first quarter of 2026 was higher compared with the first quarter of 2025, which primarily reflected an increase in investment to support product development.
Life Sciences Segment
The following summarizes first quarter Life Sciences revenues by organizational unit:
| Three months ended December 31, | |||||||||||||||||||||||||||||
| (Millions of dollars) | 2025 | 2024 |
Total Change |
Estimated FX Impact |
FXN Change | ||||||||||||||||||||||||
| Diagnostic Solutions | $ | 439 | $ | 474 | (7.4) | % | 2.2 | % | (9.6) | % | |||||||||||||||||||
| Biosciences | 327 | 361 | (9.5) | % | 2.1 | % | (11.6) | % | |||||||||||||||||||||
| Total Life Sciences Revenues | $ | 766 | $ | 836 | (8.3) | % | 2.2 | % | (10.5) | % | |||||||||||||||||||
The Life Sciences segment's revenues in the first quarter of 2026 primarily reflected the following:
•A decline in the Diagnostic Solutions unit driven by lower sales of U.S. point-of-care products and an unfavorable comparison to BD BACTECTMblood culture product sales in the prior year, partially offset by growth in sales of BD MAXTMIVD and CORTM.
•A decline in the Biosciences unit's sales of instruments due to continued market dynamics impacting life sciences research funding and an unfavorable comparison to prior-period licensing revenue.
Life Sciences segment income for the three-month periods is provided below.
| Three months ended December 31, | |||||||||||
| (Millions of dollars) | 2025 | 2024 | |||||||||
| Life Sciences segment income | $ | 159 | $ | 240 | |||||||
| Segment income as % of Life Sciences revenues | 20.8 | % | 28.7 | % | |||||||
The Life Sciences segment's operating income as a percentage of revenues in the first quarter of 2026 compared with the first quarter of 2025 primarily reflected the following:
•Gross profit margin in the first quarter of 2026 was lower compared with the first quarter of 2025, which primarily reflected the current-period decline in revenues as well as unfavorable impacts from tariffs and higher labor costs, partially offset by lower manufacturing costs resulting from continuous improvement projects, supply chain optimization and other productivity initiatives.
•Selling and administrative expense as a percentage of revenues in the first quarter of 2026 was higher compared with the first quarter of 2025 which primarily reflected the current-period decline in revenues and higher selling costs.
•Higher research and development expense as a percentage of revenues in the first quarter of 2026 compared with the first quarter of 2025, which primarily reflected the current-period decline in revenues, as well as the timing of project spending.
Geographic Revenues
BD's worldwide first quarter revenues by geography were as follows:
| Three months ended December 31, | |||||||||||||||||||||||||||||
| (Millions of dollars) | 2025 | 2024 |
Total Change |
Estimated FX Impact |
FXN Change | ||||||||||||||||||||||||
| United States | $ | 3,159 | $ | 3,080 | 2.6 | % | - | % | 2.6 | % | |||||||||||||||||||
| International | 2,093 | 2,089 | 0.2 | % | 3.0 | % | (2.8) | % | |||||||||||||||||||||
| Total Revenues | $ | 5,252 | $ | 5,168 | 1.6 | % | 1.2 | % | 0.4 | % | |||||||||||||||||||
U.S. revenue growth in the first quarter of 2026 reflected strong sales in both of the Connected Care segment's units, as well as growth in the BioPharma Systems segment and in the Interventional segment's Urology and Critical Care unit. U.S. revenue growth in the first quarter of 2026 was partially offset by a decline in the Life Sciences segment, as further discussed above.
International revenue in the first quarter of 2026 primarily reflected declines in the BioPharma Systems and Life Sciences segments, as further discussed above, which were partially offset by growth in the Interventional segment's Surgery unit. Current-period revenues in emerging markets primarily reflected a decline in China, as further discussed above, partially offset by strong sales in Latin America.
| Three months ended December 31, | |||||||||||||||||||||||||||||
| (Millions of dollars) | 2025 | 2024 |
Total Change |
Estimated FX Impact |
FXN Change | ||||||||||||||||||||||||
| Emerging markets | $ | 718 | $ | 729 | (1.6) | % | 2.1 | % | (3.7) | % | |||||||||||||||||||
Specified Items
Reflected in the financial results for the three-month periods of fiscal years 2026 and 2025 were the following specified items:
| Three months ended December 31, | |||||||||||
| (Millions of dollars) | 2025 | 2024 | |||||||||
| Integration costs (a) | $ | 36 | $ | 24 | |||||||
| Restructuring costs (a) | 75 | 66 | |||||||||
| Transaction costs (b) | - | 3 | |||||||||
| Separation-related items (c) | 38 | - | |||||||||
| Purchase accounting adjustments (d) | 391 | 570 | |||||||||
|
Product, litigation, and other items (e)
|
8 | 102 | |||||||||
| Total specified items | 548 | 764 | |||||||||
| Less: tax impact of specified items and other tax related | 100 | 71 | |||||||||
| After-tax impact of specified items | $ | 448 | $ | 693 | |||||||
(a)Represents amounts associated with restructuring and acquisition integration activities, which are recorded in Integration, restructuring and transaction expenseand are further discussed below.
(b)Represents transaction costs, which are recorded in Integration, restructuring and transaction expenseassociated with the Advanced Patient Monitoring acquisition, which occurred during the fourth quarter of fiscal year 2024.
(c)Represents costs recorded to Other operating expense, netand incurred in connection with the separation of our Biosciences and Diagnostic Solutions business and the combination of the business with Waters.
(d)Includes amortization and other adjustments related to the purchase accounting for acquisitions. BD's amortization expense is recorded in Cost of products sold. The amount in the three months ended December 31, 2024 includes $180 million recorded due to a fair value step-up adjustment relating to Advanced Patient Monitoring's inventory on the acquisition date.
(e)Includes certain (income) expense items which are not part of ordinary operations and affect the comparability of the periods presented. Such items may include certain product remediation costs, amounts related to certain legal matters, certain investment gains and losses, certain asset impairment charges, and certain pension settlement costs. The amount in the three months ended December 31, 2024 included: a charge within Cost of products soldof $22 million to adjust future costs estimated for product remediation efforts; a non-cash charge of $30 million within Research and development expenseto write down certain assets in the Life Sciences segment; and charges of approximately $29 million recorded to Other operating expense, net, related to various legal matters. Additional disclosures regarding legislative and legal matters are provided in Note 5 in the Notes to Condensed Consolidated Financial Statements.
Gross Profit Margin
The comparison of gross profit margin for the three-month periods of fiscal years 2026 and 2025 reflected the following impacts:
| Three-month period | |||||
|
December 31, 2024 gross profit margin %
|
43.3 | % | |||
| Impact of purchase accounting adjustments and other specified items | 4.0 | % | |||
| Operating performance | (1.3) | % | |||
| Foreign currency impact | (0.1) | % | |||
|
December 31, 2025 gross profit margin %
|
45.9 | % | |||
The favorable impact on gross margin for the three-month period of 2026 from specified items reflected a favorable comparison to specified items recorded in the prior-year period, which included an impact of $180 million resulting from a fair value step-up adjustment relating to Advanced Patient Monitoring's inventory on the acquisition date. Specified items in the prior-year period also included a charge of $22 million recorded in the Connected Care segment to adjust the estimate of future product remediation costs.
Operating performance in the three-month period of 2026 compared with the prior-year period primarily reflected higher tariffs and labor costs, partially offset by lower manufacturing costs resulting from our ongoing continuous improvement projects, supply chain optimization, and other productivity initiatives.
Operating Expenses
A summary of operating expenses for the three-month periods of fiscal years 2026 and 2025 is as follows:
|
Three months ended December 31, |
Increase (decrease) in basis points | ||||||||||||||||
| 2025 | 2024 | ||||||||||||||||
| (Millions of dollars) | |||||||||||||||||
| Selling and administrative expense | $ | 1,393 | $ | 1,318 | |||||||||||||
| % of revenues | 26.5 | % | 25.5 | % | 100 | ||||||||||||
| Research and development expense | $ | 306 | $ | 343 | |||||||||||||
| % of revenues | 5.8 | % | 6.6 | % | (80) | ||||||||||||
| Integration, restructuring and transaction expense | $ | 111 | $ | 92 | |||||||||||||
| Other operating expense, net | $ | 50 | $ | 28 | |||||||||||||
Selling and administrative expense
Selling and administrative expense as a percentage of revenues in the three-month period of 2026 was higher compared with the prior-year period, which primarily reflected higher selling costs in the current-year period.
Research and development expense
Research and development expense as a percentage of revenues in the three-month period of 2026 was lower compared with the prior-year period, which primarily reflected the timing of project spending and a favorable comparison to the prior-year period, which reflected a $30 million write-down of certain assets in the Life Sciences segment.
Integration, restructuring and transaction expense
The amounts in the three-month periods of 2026 and 2025 included restructuring costs related to simplification and other cost-saving initiatives, as well as integration costs relating to our acquisition of the Advanced Patient Monitoring unit, which occurred during the fourth quarter of fiscal year 2024. The amount in the three-month period of 2025 also included restructuring and transaction costs related to the Advanced Patient Monitoring unit acquisition. For further disclosures regarding restructuring costs, refer to Note 9 in the Notes to Condensed Consolidated Financial Statements.
Other operating expense, net
The amount in the three-month period of 2026 largely represented costs incurred in connection with the separation of our Biosciences and Diagnostic Solutions business and the combination of the business with Waters, and the amount in 2025 largely represented charges relating to legal matters. Additional disclosures regarding the separation and legal matters are provided in Notes 1 and 5, respectively, in the Notes to Condensed Consolidated Financial Statements.
Nonoperating Income
Net interest expense
The components for the three-month periods of fiscal years 2026 and 2025 were as follows:
| Three months ended December 31, | |||||||||||
| (Millions of dollars) | 2025 | 2024 | |||||||||
| Interest expense | $ | (153) | $ | (155) | |||||||
| Interest income | 4 | 23 | |||||||||
| Net interest expense | $ | (149) | $ | (132) | |||||||
Interest expense for the three-month period of fiscal year 2026 was flat compared with the prior-year period. Lower interest income for the three-month period of fiscal year 2026 compared with the prior-year period primarily reflected lower levels of U.S. cash on hand.
Income Taxes
The income tax rates for the three-month periods of fiscal year 2026 and 2025 are provided below.
| Three months ended December 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Effective income tax rate | 2.8 | % | 0.9 | % | |||||||
| Impact, in basis points, from specified items | (900) | (600) | |||||||||
The effective income tax rate for the three-month period of fiscal year 2026 compared with the prior-year period reflected a less favorable net impact from discrete items.
Net Income and Diluted Earnings per Share
Net income and diluted earnings per share for the three-month periods of fiscal years 2026 and 2025 were as follows:
| Three months ended December 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Net Income (Millions of dollars) | $ | 382 | $ | 303 | |||||||
| Diluted Earnings per Share | $ | 1.34 | $ | 1.04 | |||||||
| Unfavorable impact-specified items | $ | (1.57) | $ | (2.39) | |||||||
| Favorable impact-foreign currency translation | $ | 0.01 | |||||||||
Liquidity and Capital Resources
The following table summarizes our condensed consolidated statements of cash flows:
| Three months ended December 31, | |||||||||||
| (Millions of dollars) | 2025 | 2024 | |||||||||
| Net cash provided by (used for): | |||||||||||
| Operating activities | $ | 657 | $ | 693 | |||||||
| Investing activities | $ | (183) | $ | 204 | |||||||
| Financing activities | $ | (302) | $ | (1,928) | |||||||
Net Cash Flows from Operating Activities
Cash flows from operating activities in the first three months of fiscal year 2026 were largely driven by our net income, adjusted by a change in operating assets and liabilities that was a net use of cash. This net use of cash primarily reflected lower levels of accounts payable and accrued expenses, as well as higher levels of inventory and prepaid expenses, partially offset by lower levels of trade receivables.
Cash flows from operating activities in the first three months of fiscal year 2025 was largely driven by our net income, adjusted by a change in operating assets and liabilities that was a net use of cash. This net use of cash primarily reflected higher levels of inventory and prepaid expenses, as well as lower levels of accounts payable and accrued expenses, partially offset by lower levels of trade receivables. The decrease in accounts payable and accrued expenses reflected our payment of $175 million relating to the SEC investigation as further discussed in Note 5 in the Notes to Condensed Consolidated Financial Statements.
Net Cash Flows from Investing Activities
Our investments in capital expenditures are focused on projects that enhance our cost structure and manufacturing capabilities, as well as support the objectives of our growth strategy. Cash flows from investing activities in the first three months of fiscal year 2026 included capital expenditure-related outflows of $108 million, compared with $105 million in the prior-year period. Prior-period cash flows from investing activities also included a $411 million inflow attributable to the maturity of time deposits.
Net Cash Flows from Financing Activities
Net cash flows from financing activities in the first three months of fiscal years 2026 and 2025 included the following significant cash flows:
| Three months ended December 31, | |||||||||||
| (Millions of dollars) | 2025 | 2024 | |||||||||
| Cash inflow (outflow) | |||||||||||
| Change in short-term debt | $ | 317 | $ | 75 | |||||||
| Payments of debt | $ | - | $ | (875) | |||||||
| Repurchases of common stock | $ | (250) | $ | (750) | |||||||
| Dividends paid | $ | (299) | $ | (302) | |||||||
Certain measures relating to our total debt were as follows:
| (Millions of dollars) | December 31, 2025 | September 30, 2025 | |||||||||
| Total debt | $ | 19,540 | $ | 19,181 | |||||||
| Weighted average cost of total debt | 3.4 | % | 3.4 | % | |||||||
| Total debt as a percentage of total capital* | 43.1 | % | 42.6 | % | |||||||
* Represents shareholders' equity, net non-current deferred income tax liabilities, and debt.
Cash and Short-Term Investments
At December 31, 2025, total worldwide cash and equivalents and short-term investments, including restricted cash, were approximately $1.035 billion and were primarily held outside of the United States. We regularly review the amount of cash and short-term investments held outside of the United States and our historical foreign earnings are used to fund foreign investments or meet foreign working capital and property, plant and equipment expenditure needs. To fund cash needs in the United States, we rely on ongoing cash flow from U.S. operations, access to capital markets and remittances from foreign subsidiaries of earnings that are not considered to be permanently reinvested.
Financing Facilities
We have a senior unsecured revolving credit facility in place which will expire in September 2030. The credit facility provides borrowings of up to $2.750 billion, with separate sub-limits of $100 million and $236 million for letters of credit and swingline loans, respectively. The expiration date of the credit facility may be extended for up to two additional one-year periods, subject to certain restrictions (including the consent of the lenders). The credit facility provides that we may, subject to additional commitments by lenders, request an additional $500 million of financing, for a maximum aggregate commitment under the credit facility of up to $3.250 billion. Proceeds from this facility may be used for general corporate purposes and Becton Dickinson Euro Finance S.à r.l., an indirect, wholly owned finance subsidiary of BD, is authorized as an additional borrower under the credit facility. There were no borrowings outstanding under the revolving credit facility at December 31, 2025.
The agreement for our revolving credit facility contains the following financial covenants. We were in compliance with these covenants, as applicable, as of December 31, 2025.
•We are required to have a leverage coverage ratio of no more than:
◦4.25-to-1 as of the last day of each fiscal quarter following the closing of the credit facility; or
◦4.75-to-1 for the five full fiscal quarters following the consummation of a material acquisition.
We may access commercial paper programs over the normal course of our business activities. Our U.S. and multicurrency euro commercial paper programs provide for a maximum amount of unsecured borrowings under the two programs, in aggregate, of $2.750 billion. Proceeds from these programs may be used for working capital purposes and general corporate purposes, which may include acquisitions, share repurchases and repayments of debt. We had $1.172 billion of commercial paper borrowings outstanding as of December 31, 2025. We have additional informal lines of credit outside the United States. Also, over the normal course of our business activities, we transfer certain trade receivable assets to third parties under factoring agreements. Additional disclosures regarding sales of trade receivable assets are provided in Note 12 in the Notes to Condensed Consolidated Financial Statements.
Access to Capital and Credit Ratings
Our corporate credit ratings with Standard & Poor's Ratings Services ("S&P"), Moody's Investors Service ("Moody's) and Fitch Ratings ("Fitch") at December 31, 2025 were unchanged compared with our ratings at September 30, 2025.
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.
Concentrations of Credit Risk
We continually evaluate our accounts receivables for potential credit losses, particularly those resulting from sales to government-owned or government-supported healthcare facilities in certain countries, as payment may be dependent upon the financial stability and creditworthiness of those countries' national economies. In addition to continually evaluating all governmental receivables for potential credit losses based upon historical loss experiences, we also evaluate such receivables based upon the availability of government funding and reimbursement practices. We believe the current reserves related to all governmental receivables are adequate and that these receivables will not have a material adverse impact on our financial position or liquidity.
To date, we have not experienced a significant increased risk of credit losses in general as a result of current macroeconomic conditions. No assurances can be given that the risk of credit losses will not increase in the future given the uncertainty around the duration of the current macroeconomic challenges and pressures.
Other Matters
Critical Accounting Policies
There were no changes to our critical accounting policies from those disclosed in our 2025 Annual Report.
Regulatory Matters
Consent Decree with FDA
Our U.S. infusion pump organizational unit is operating under an amended consent decree originally entered into by Cardinal Health 303, Inc. with the FDA in 2007 related to its Alaris™ infusion pumps. In 2009, the decree was amended (the "Consent Decree") to include all infusion pumps manufactured by or for CareFusion 303, Inc., which was acquired by BD in 2015. CareFusion 303, Inc. remains the manufacturer of BD Alaris™ infusion pumps. The Consent Decree is specific to infusion pumps and does not apply to intravenous administration sets, accessories, or other products.
Following an inspection that began in March 2020 of our Medication Management Systems' Infusion quality management system operating out of the site in San Diego, California (CareFusion 303, Inc.), the FDA issued a Form 483 Notice (the "2020 Form 483 Notice") that contained a number of observations regarding the quality system's compliance with FDA's Quality System, reporting of corrections and removals, and Medical Device Reporting ("MDR") regulations. In December 2021, the FDA issued to CareFusion 303, Inc. a letter of non-compliance with respect to the Consent Decree (the "Non-Compliance Letter") stating that, among other things, it had determined that certain of the corrective actions to address the 2020 Form 483 Notice appeared to be adequate, some were still in progress such that adequacy could not be determined yet, and certain others were not adequate (e.g., complaint handling and corrective and preventive actions, design verification and medical device reporting). Per the terms of the Non-Compliance Letter, CareFusion 303, Inc. provided the FDA with a proposed comprehensive corrective action plan ("CAP") and has retained an independent expert to conduct periodic audits of the quality management system operating at the CareFusion 303, Inc. infusion pump facilities through 2025. All required audits are complete, and the final audit report was delivered to FDA in January 2026. CareFusion 303, Inc. has and will continue to update its CAP as necessary to address all audit observations.
In addition, CareFusion 303, Inc. received an additional Form 483 Notice in May 2024 following an FDA inspection ("2024 Form 483 Notice") that contained observations related to the site's compliance with the FDA's quality system regulation ("QSR") for its Infusion quality management system (covered by the Consent Decree) and QSR and MDR regulation for its separate Dispensing quality management system (which is not subject of the Consent Decree). On November 22, 2024, BD received a Warning Letter from the FDA, which is limited to CareFusion 303, Inc.'s Dispensing quality management system and BD Pyxis™ products ("Dispensing Warning Letter"). See "-FDA Warning Letters" below for further information.
The FDA's review of our responses to the observations specific to the Infusion quality management system in the 2024 Form 483 Notice and the CAP is ongoing, and no assurances can be given regarding further action by the FDA as a result of the observations, including but not limited to action pursuant to the Consent Decree, or that corrective actions proposed by CareFusion 303, Inc. will be adequate to address these observations. Additionally, we cannot currently predict the amount of additional monetary investment that will be incurred to resolve this matter or the matter's ultimate impact on our business.
The Consent Decree authorizes the FDA, in the event of any violations in the future, to order us to cease manufacturing and distributing infusion pumps, recall products and take other actions. We may be required to pay damages of $15,000 per day per violation if we fail to comply with any provision of the Consent Decree, up to $15 million per year.
We may be obligated to pay more costs in the future because, among other things, the FDA may determine that we are not fully compliant with the Consent Decree and Non-Compliance Letter and therefore impose penalties under the Consent Decree, and/or we may also be subject to future proceedings and litigation relating to the matters addressed in the Consent Decree, including, but not limited to, additional fines, penalties, other monetary remedies, and expansion of the terms of the Consent Decree. As of December 31, 2025, we do not believe that a loss is probable in connection with the Consent Decree, and accordingly, we have no accruals associated with compliance with the Consent Decree.
As previously disclosed, on July 21, 2023, BD received 510(k) clearance from the FDA for its updated BD Alaris™ Infusion System, which enabled both remediation and a return to market for the BD Alaris™ Infusion System. This clearance covers updated hardware features for Point-of-Care Unit ("PCU"), large volume pumps, syringe pumps, patient-controlled analgesia ("PCA") pumps, respiratory monitoring and auto-identification modules. It also covers a new BD Alaris™ Infusion System software version with enhanced cybersecurity, along with interoperability features that enable smart, connected care with electronic medical record systems. To address open recalls and ensure devices at customer sites are running a recent, cleared version of the BD Alaris™ Infusion System Software, BD Alaris™ Infusion System devices in the U.S. market are being remediated or replaced with the updated 510(k) cleared version, which we expect to be substantially complete over the next
calendar year. Additionally, on April 25, 2025, BD received 510(k) clearance from the FDA on an updated BD Alaris™ Infusion System.
FDA Warning Letters
On January 11, 2018, BD received a Warning Letter from the FDA with respect to our former BD Preanalytical Systems ("PAS") unit, citing certain alleged violations of quality system regulations and of law. BD has worked closely with the FDA and implemented corrective actions to address the quality management system concerns identified in the Warning Letter. 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 associated with the quality management concerns in the inspection. Additionally, in December 2022, the FDA conducted a subsequent inspection of PAS (now Specimen Management) with no observations. We continue to work with the FDA to generate additional clinical evidence and file 510(k)s as remaining commitments associated with the Warning Letter. As of December 31, 2025, we have received eight FDA clearances. The FDA review of these remaining commitments is ongoing, and no assurances can be given regarding further action by the FDA as a result of these commitments, including but not limited to action pursuant to the Warning Letter.
As noted above, on November 22, 2024, BD received the Dispensing Warning Letter following an inspection of its Dispensing quality management system at its facility located in San Diego, California, citing certain alleged violations of the quality system regulations, MDR regulation, the corrections and removals reporting regulation and law. BD submitted a comprehensive response to address FDA's feedback in the Dispensing Warning Letter, which committed to implementing additional corrective actions; however, no assurances can be given regarding further action by the FDA as a result of FDA's Dispensing Warning Letter, or that corrective actions proposed and taken by CareFusion 303, Inc. will be adequate to address the Dispensing Warning Letter. Any failure to adequately address the Dispensing Warning Letter may result in regulatory actions initiated by the FDA without further notice, which may include, but are not limited to, seizure, injunction and civil monetary penalties. As a result, the ultimate resolution of the Dispensing Warning Letter and its impact on the Company's operations is unknown at this time. In connection with the Dispensing Warning Letter, the Company recorded a liability for estimated future costs associated with certain actions required to respond to the Warning Letter and to address the non-conformities. See Note 5 in the Notes to Condensed Consolidated Financial Statements. It is possible that the amount of the Company's liability could exceed its currently accrued amount.
El Paso, Texas Inspection
BD's El Paso, Texas facility was inspected by the FDA in October 2025, resulting in the issuance by the FDA of a Form 483 Notice (the "El Paso 483"). BD provided its timely response and corrective action plan to the FDA in November 2025. BD is also providing the FDA with regular El Paso 483 response updates which identify the progress that has been made to date. On January 30, 2026, BD received a notification from the FDA that the inspection was classified as "Official Action Indicated", which means that regulatory and/or administrative actions are recommended. To date, BD has not received any notice of FDA regulatory or administrative action and there can be no assurance as to the nature or scope of any such regulatory or administrative action or any response that may be required from BD. BD will continue to implement the corrective actions identified in its El Paso 483 response and will take additional action as needed.
Ethylene Oxide/Sterilization
There is increased focus on the use and emission of ethylene oxide by the U.S. Environmental Protection Agency ("EPA") and state environmental regulatory agencies. Additional regulatory requirements associated with the use and emission of ethylene oxide may be imposed in the future, either domestically or outside the United States. Ethylene oxide is the most frequently used sterilant for medical devices and healthcare products in the United States, and in certain cases is the only option to sterilize critical medical device products for the safe administration to patients. Any such increased regulation could require BD or sterilization service providers, including providers used by BD, to temporarily suspend operations to install additional emissions control technology, limit the use of ethylene oxide or take other actions, which would impact BD's operations and further reduce the available capacity to sterilize medical devices and healthcare products, and could also result in additional costs. To this end, BD has proactively installed fugitive emissions controls at our facilities in East Columbus, NE and Sandy, UT. On April 5, 2024, the final National Emission Standards for Hazardous Air Pollutants ("NESHAP"): Ethylene Oxide Emissions Standards for Sterilization Facilities regulation issued by the EPA became effective. Companies generally have two years from the effective date to comply with the new requirements of the revised NESHAP. On July 17, 2025, the White House issued a Presidential Proclamation under the Clean Air Act exempting certain sterilization facilities for two years from compliance with the EPA's revised NESHAP for ethylene oxide emissions from sterilization facilities to allow these facilities more time to design, procure, install and test new control technology and implement other changes to ensure compliance with the revised NESHAP. While BD's ethylene oxide sterilization facilities received this Presidential compliance exemption we continue to implement certain changes to our facilities in accordance with the revised NESHAP's requirements, and such
measures will require additional implementation and ongoing operational costs, including investments in certain new technologies.
In addition, on January 14, 2025, the EPA published a Notice of Availability for a Pesticide Registration Review; Interim Registration Review Decision for Ethylene Oxide ("ID"). The ID, which regulates the use of ethylene oxide as a sterilant and is intended to mitigate human health and environmental risks associated with its use. In conjunction with the upgrades and operational changes related to the NESHAP, we are currently investing in new technologies and implementing additional work-practices to comply with the revised pesticide use requirements for ethylene oxide at our sterilization facilities. Certain requirements of the ID became effective as of January 2026 while others will become effective over the next several years.
If any new or existing regulatory requirements or rulemaking result in the suspension, curtailment or interruption of sterilization operations at BD or at medical device sterilizers used by BD, or otherwise limit the availability of third-party sterilization capacity, this could interrupt or otherwise adversely impact production of certain of our products or lead to civil litigation or other claims against us. We have business continuity plans in place to mitigate the impact of any such disruptions, although these plans may not be able to fully offset such impact, for the reasons noted above.
For further discussion of risks relating to the regulations to which we are subject, see Part I, Item 1A, of our 2025 Annual Report.
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 the SEC, press releases, and our reports to shareholders. Forward-looking statements may be identified by the use of words such as "plan," "expect," "believe," "intend," "will," "may," "anticipate," "estimate" and other words of similar meaning in conjunction with, among other things, discussions of future operations and financial performance (including volume growth, pricing, sales and earnings per share growth, and cash flows) and statements regarding our strategy for growth, liquidity, future product development, regulatory approvals, competitive position and expenditures. All statements that address our future operating performance or events or developments that we expect or anticipate will occur in the future are forward-looking statements.
Forward-looking statements are, and will be, based on management's then-current views and assumptions regarding future events, developments and operating performance, and speak only as of their dates. Investors should realize that if underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results could vary materially from our expectations and projections. Investors are therefore cautioned not to place undue reliance on any forward-looking statements. Furthermore, we undertake no obligation to update or revise any forward-looking statements after the date they are made, whether as a result of new information, future events and developments or otherwise, except as required by applicable law or regulations.
The following are some important factors that could cause our actual results to differ from our expectations in any forward-looking statements. For further discussion of certain of these factors, see Part I, Item 1A. Risk Factors in our 2025 Annual Report, and our subsequent Quarterly Reports on Form 10-Q.
•General global, regional or national economic downturns and macroeconomic trends, including heightened inflation, capital market volatility (including volatility resulting from the imposition of (and changing policies around) tariffs and related countermeasures), import or export licensing requirements, other governmental restrictions, interest rate and currency rate fluctuations, and economic slowdown or recession, that may result in unfavorable conditions that could negatively affect demand for our products and services, impact the prices we can charge for our products and services, disrupt aspects of our supply chain, impair our ability to produce our products, or increase borrowing costs.
•The impact of inflation, tariffs, and disruptions in our global supply chain on us and our suppliers (particularly sole-source suppliers and providers of sterilization services), including fluctuations in the cost and availability of oil-based resins and other raw materials, as well as certain components, used in the production or sterilization of our products, transportation constraints, disruptions and delays, product shortages, energy shortages or increased energy costs, labor shortages or disputes, and increased operating and labor costs.
•The risks associated with the combination of our Biosciences and Diagnostic Solutions business with Waters, including factors that could prevent or otherwise adversely affect our ability to realize the expected benefits of the transaction.
•Conditions in international markets, including social and political conditions, geopolitical developments such as the continuation and/or escalation of the situations in Ukraine, the Middle East and Asia, civil unrest, political conflict, terrorist activity, governmental changes, restrictions on the ability to transfer capital across borders, economic sanctions, export controls, tariffs and other protectionist measures, barriers to market participation (such as local company and products preferences), difficulties in protecting and enforcing our intellectual property rights, and governmental
expropriation of assets. Our international operations also increase our compliance risks, including risks under the Foreign Corrupt Practices Act and other anti-corruption and bribery laws, as well as regulatory and privacy laws.
•The impact of changes in U.S. federal, state, or foreign laws and policies that could affect fiscal and tax policies, taxation (including tax reforms such as the Pillar Two framework) and international trade, including import and export licensing regulation and international trade agreements. In particular, tariffs, sanctions or other trade barriers imposed by the U.S. (and countermeasures by non-U.S. governments) could adversely impact demand for our products and services, our supply chain costs or otherwise adversely impact our results of operations and future growth. The ultimate impact of any existing or new tariffs or other changes in international trade policies is subject to a number of factors including the duration of such tariffs, changes in tariff rates, the scope and nature of the tariffs, any countermeasures that target countries may take and the availability of any mitigating actions. In addition, our tariff mitigation strategies have been, and may be further challenged, rejected or eliminated through legislation or other challenges, or may otherwise not be effective.
•Cost-containment efforts in the U.S. or in other countries in which we do business, such as alternative payment reform, government-imposed pay back provisions, increased use of competitive bidding and tenders, including, without limitation, any expansion of the volume-based procurement process in China or the Center for Medicaid Services' Competitive Bidding Program, reimbursement policy changes or the implementation of similar cost-containment efforts.
•Competitive factors that could adversely affect our operations, including new product introductions and technologies, including the use of emerging technologies (such artificial intelligence ("AI")) by our current or future competitors, changes in demand as a result of changes to U.S. federal and state policies (affecting products such as pharmaceuticals and vaccines), change in research and development efforts, investment or suspension by pharmaceuticals companies with regard to vaccine development, consolidation or strategic alliances among healthcare companies, distributors and/or payers of healthcare to improve their competitive position or develop new models for the delivery of healthcare, increased pricing pressure due to the impact of low-cost manufacturers, patents attained by competitors (particularly as patents on our products expire), new entrants into our markets, changes in the practice of medicine or the development of alternative therapies for disease states that may be delivered without a medical device.
•Product efficacy or safety concerns, changes to the labeled use of our products, non-compliance with applicable regulatory requirements regarding our products (such as non-compliance of our products with marketing authorization or registration requirements resulting from modifications to such products, or other factors, including, but not limited to, with respect to BD Alaris™ System and infusion sets and BD VacutainerTMresulting in product recalls, lost revenue or other actions being taken with respect to products in the field or the ability to continue selling new products to customers (including restrictions on future product clearances and civil penalties), product liability or other claims and damage to our reputation, including products we acquire through acquisitions. As a result of the CareFusion acquisition, our U.S. infusion pump business is operating under a Consent Decree with the FDA. The Consent Decree authorizes the FDA, in the event of any violations in the future, to order our U.S. infusion pump business to cease manufacturing and distributing products, recall products or take other actions, and order the payment of significant monetary damages if the business subject to the decree fails to comply with any provision of the Consent Decree. In accordance with our commitments to the FDA, the overall timing of replacement of the BD Alaris™ Infusion Systems and return to market in the U.S. may be impacted by, among other things, customer readiness, supply continuity and our continued engagement with the FDA.
•Policy and regulatory changes implemented by the U.S. federal government, including the downsizing and reduced funding of certain government agencies and programs as well as changes in the policy positions of such agencies, including the FDA, may affect the approach of agencies with which we typically engage and make regulatory approval processes and ongoing compliance with all applicable rules and regulations more challenging.
•Deficit reduction efforts, policy changes, or other actions that reduce or freeze the availability of government funding for healthcare and research, which could weaken demand for our products and result in additional pricing pressures, as well as create potential collection risks associated with such sales.
•Fluctuations and pauses in university or U.S. and international governmental funding and policies for research.
•Changes in the way healthcare services are delivered, including transition of more care from acute to non-acute settings and increased focus on chronic disease management, which may affect the demand for our products and services. Additionally, budget constraints and staffing shortages, particularly shortages of nursing staff, may affect the prioritization of healthcare services, which could also impact the demand for certain of our products and services.
•Our ability to achieve our projected level or mix of product sales, as our earnings forecasts are based on projected sales volumes and pricing of many product types, some of which are more profitable than others.
•Changes in market dynamics, coverage policies or reimbursement practices, or adverse third-party payer cost containment measures relating to our products and services, which could reduce demand for our products or the price we can charge for such products.
•Changes in the domestic and foreign healthcare industry, in medical or clinical practices or in patient preferences that result in a reduction in procedures using our products or increased pricing pressures, including cost-reduction measures instituted by and the continued consolidation among healthcare providers.
•The effects of regulatory or other events that adversely impact our supply chain, including our ability to manufacture or sterilize our products (particularly where production of a product line or sterilization operations are concentrated in one or a few plants), source materials or components or services from suppliers (including sole-source suppliers) that are needed for such manufacturing or sterilization, or provide products to our customers, including events that impact key distributors. In particular, there has been increased regulatory focus on the use and emission of ethylene oxide in sterilization processes, and additional regulatory requirements may be imposed in the future that could adversely impact us or our third-party sterilization providers.
•IT system disruptions, breaches or breakdowns, including through cyberattacks, ransom attacks or cyber-intrusion, which could impair our ability or that of our customers, suppliers and other business partners to conduct business, result in the loss of our trade secrets or otherwise compromise sensitive information of BD or its customers, suppliers and other business partners, or of patients, including sensitive personal data, or result in efficacy or safety concerns for certain of our products, and result in investigations, legal proceedings, liability, expense or reputational damage or actions by regulatory bodies or civil litigation.
•Difficulties inherent in product development, including the potential inability to successfully continue technological innovation, successfully complete clinical trials, obtain and maintain regulatory approvals, clearances and registrations in the U.S. and abroad, obtain intellectual property protection for our products, obtain coverage and adequate reimbursement for new products, or gain and maintain market approval of products, as well as the possibility of infringement claims by competitors with respect to patents or other intellectual property rights, all of which could preclude or delay commercialization of a product. Delays in obtaining necessary approvals or clearances from the FDA or other regulatory agencies due to government shutdowns or reductions in government staffing or changes in the regulatory process may also delay product launches and increase development costs.
•The impact of business combinations or divestitures, including any volatility in earnings relating to acquisition-related costs, and our ability to successfully integrate any business we may acquire.
•Risks relating to our overall level of indebtedness, including our ability to service our debt and refinance our indebtedness, which is dependent upon the capital markets and the overall macroeconomic environment and our financial condition at such time.
•The risks associated with the qualification of the spin-off of our former Diabetes Care business as a tax-free transaction for U.S. federal income tax purposes.
•Risks associated with our development, deployment and use of AI in our products and business operations.
•Our ability to penetrate or expand our operations in emerging markets, which depends on local economic and political conditions, and how well we are able to make necessary infrastructure enhancements to production facilities and distribution networks.
•Our ability to recruit and retain key employees and the impact of labor conditions which could increase employee turnover or increase our labor and operating costs and negatively affect our ability to efficiently operate our business.
•Fluctuations in the demand for products we sell to pharmaceutical companies that are used to manufacture, or are sold with, the products of such companies, as a result of funding constraints, consolidation, the development of alternative therapies for disease states that may be delivered without a medical device, or otherwise.
•The impact of climate change, legal, regulatory or market measures to address climate change, such as regulation of greenhouse gas emissions, zero-carbon energy and sustainability mandates and related disclosure requirements, and additional taxes on fuel and energy, or related sustainability efforts, and changing customer and other stakeholder preferences and requirements, such as those regarding the use of materials of concern, shifting demand for products with lower environmental footprints, and for progress toward sustainability goals and greenhouse gas reduction targets.
•Natural disasters, including the impacts of hurricanes, tornadoes, windstorms, fires, earthquakes and floods and other extreme weather events, public health crises (such as pandemics and epidemics), war, terrorism, labor disruptions and international conflicts that could cause significant economic disruption and political and social instability, resulting in decreased demand for our products, adversely affect our manufacturing and distribution capabilities or cause
interruptions in our supply chain, and our response may involve the implementation of measures which may not be successful.
•Pending and potential future litigation or other proceedings asserting, and/or investigations concerning and/or subpoenas and requests seeking information with respect to, alleged violations of law (including in connection with federal and/or state healthcare programs (such as Medicare or Medicaid), government contracts and/or sales and marketing practices (such as investigative subpoenas and the civil investigative demands received by us)), potential anti-corruption and related internal control violations under the Foreign Corrupt Practices Act, antitrust claims, securities law claims, environmental and product liability matters (including pending claims relating to ethylene oxide, our hernia repair implant products, surgical continence and pelvic organ prolapse products for women, vena cava filter products and implantable ports, which involve, or could involve in the future, lawsuits seeking class action status or seeking to establish multi-district or other consolidated proceedings), data privacy breaches and patent infringement, and the availability or collectability of insurance relating to any such claims.
•New or changing laws and regulations affecting our domestic and foreign operations, or changes in enforcement practices, including, without limitation, laws relating to sales practices, healthcare, environmental protection and reporting, price controls, privacy, data protection, cybersecurity, AI, employment, labor and licensing and regulatory requirements for new products and products in the post-marketing phase. In particular, the U.S. and other countries may impose new requirements regarding registration, labeling or prohibited materials that may require us to re-register products already on the market or otherwise impact our ability to market our products. New environmental laws, particularly with respect to the emission of greenhouse gases, may also increase our costs of operations or necessitate changes in our manufacturing plants or processes or those of our suppliers, or result in liability to us.
•The effect of adverse media exposure or other publicity regarding our business or operations, including the effect on our reputation or demand for our products.
•The effect of market fluctuations on the value of assets in our pension plans and on actuarial interest rate and asset return assumptions, which could require us to make additional contributions to the plans or increase our pension plan expense.
•Our ability to obtain the anticipated benefits of restructuring programs, if any, that we may undertake.
The foregoing list sets forth many, but not all, of the factors that could impact our ability to achieve results described in any forward-looking statements. Investors should understand that it is not possible to predict or identify all such factors and should not consider this list to be a complete statement of all potential risks and uncertainties.
BD - Becton, Dickinson and Company published this content on February 09, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on February 09, 2026 at 21:20 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]