Becton, Dickinson and Company (BDX) SEC Filings & Earnings Calls

FDA Warning Letter - El Paso Facility

“On April 30, 2026, BD’s El Paso manufacturing facility received a Warning Letter from the FDA’s Center for Drug Evaluation and Research following an October 2025 Drug Quality Assurance inspection related to drug-device combination products manufactured at the site, including ChloraPrep TM and PurPrep TM (the "El Paso Warning Letter").” · word for word

FDA Warning Letter - Dispensing Quality System

“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").” · word for word

Consent Decree - Infusion Pumps

“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.” · word for word

Tariff Impact on Operating Expense

“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.” · word for word

Ethylene Oxide Regulation

“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” · word for word

Spin-off execution risk: The company completed spin-off of Biosciences and Diagnostic Solutions business in February 2026, which may cause operational disruption or unexpected costs.

“On February 9, 2026, the company completed the spin-off of BD's former Biosciences and Diagnostic Solutions business and the combination of the business with Waters Corporation” · word for word

Foreign exchange exposure: International revenue growth was only 0.6% on a currency-neutral basis vs 3.2% reported, indicating FX headwinds.

“International revenue +3.2% reported vs +0.6% FXN”

Transition risk during search for Medical Essentials president; but Garrison stays through fiscal year end

“Garrison will remain in his role through the end of the fiscal year to support a smooth transition” · word for word

FDA Warning Letter for El Paso facility may lead to further regulatory actions or operational disruptions.

“Warning Letter received from the FDA for the El Paso manufacturing facility” · word for word

Debt service obligation increases; interest expense will rise by ~€23M annually.

“€600M at 3.855% implies annual interest of ~€23.13M”

Change of control trigger requires 101% repurchase offer, potential liquidity event.

“If a Change of Control Triggering Event occurs... Becton Finance will be required to make an offer... at 101% of principal” · word for word

Higher interest cost vs. refinanced notes (1.208% to 3.855%).

“New notes at 3.855% vs. existing 1.208% notes.”

Tariff cost pressure

“Tariffs have adversely impacted our second quarter fiscal year 2026 operating expense and we expect a continued adverse impact to operating expense for fiscal year 2026 and potentially beyond.” · word for word

FDA Warning Letter - El Paso facility

“On April 30, 2026, BD’s El Paso manufacturing facility received a Warning Letter from the FDA ... BD has voluntarily determined to put ChloraPrep TM and PurPrep TM on ship hold in the U.S.” · word for word

China VoBP headwinds

“Both the Medication Delivery Solutions and Specimen Management units were unfavorably impacted by market dynamics in China, including VoBP.” · word for word

Lower vaccine demand

“Lower demand for vaccines has also adversely impacted our results of operations.” · word for word

GAAP EPS negative due to charges; adjusted EPS positive but non-GAAP adjustments may mask underlying costs.

“GAAP diluted EPS from continuing operations of $(0.13)”

Leadership transition in Interventional segment may cause temporary uncertainty.

“Departure of segment president; no successor named yet.”

Execution risk in tender offer; potential balance sheet leverage impact.

“tender offers subject to acceptance levels, caps, and proration”

FDA Consent Decree and Warning Letters

“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.” · word for word

Tariff Exposure

“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” · word for word

China VoBP and Regulatory Pressure

“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” · word for word

Ethylene Oxide Regulation

“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, this could interrupt or otherwise adversely impact production of certain of our products” · word for word

Execution risk related to the separation and integration of the Biosciences and Diagnostic Solutions business with Waters Corporation.

“The filing details multiple agreements (Tax, Employee, IP, Transition Services) indicating complexity and potential operational disruption during the transition period.”

Life Sciences segment revenue declined 8.3% due to the planned separation, indicating ongoing transition risk.

“BD Life Sciences $766M (-8.3%)”

Potential dilution from preferred stock issuance, though likely limited as part of a rights plan.

“Issuance of Series D Junior Participating Redeemable Preferred Stock.”

Severance plan could increase costs in case of executive departures

“Severance plan provides lump sum payments and benefits for certain terminations”

Tariff impact on financial results

“the unanticipated tariffs imposed by the U.S. government and reciprocal tariffs imposed by its trading partners” · word for word

Product liability and litigation exposure

“charges of $297 million to Other operating expense, net, related to product liability and certain other legal matters” · word for word

Product remediation costs

“charges of $98 million to Cost of products sold to adjust the estimate of future product remediation costs” · word for word

Pension settlement costs

“charges of $38 million to Other expense, net, related to pension settlement costs” · word for word

Asset impairment in Life Sciences segment

“a charge of $30 million to Research and development expense related to a non-cash asset impairment charge in the Life Sciences segment” · word for word

Transaction Completion Risk

“The proposed combination of our Biosciences and Diagnostic Solutions business with Waters may not be completed, on the currently contemplated timeline or at all.” · word for word

Debt Service Risk

“We may not be able to service all of our indebtedness.” · word for word

Cybersecurity Risk

“Cybersecurity incidents and breaches or breakdowns of our information and technology systems or infrastructure could have a material adverse effect on our operations.” · word for word

Volume-based procurement in China may pressure MDS growth.

“MDS performance reflects strong growth led by Vascular Access Management, partially offset by volume-based procurement in China.” · word for word