Becton Dickinson
30 named things its latest annual report says its results depend on, each in the company's own words. 22 of them are also named by other companies we've read.
Customers
Group purchasing organizations
earns fromnamed as a riskGroup purchasing organizations and integrated health delivery networks have also served to concentrate purchasing decisions for some customers, which has led to downward pricing pressure for medical device suppliers.Risk factors (Item 1A)
Also named by BAX, BSX, CDW, EW, GMED, GWW, SYY, USFD and 1 more
Suppliers
Sole-source suppliers
depends onnamed as a riskOur reliance on sole suppliers can create greater exposure to shortages, magnify price swings and increase the difficulty of negotiating favorable terms.Risk factors (Item 1A)
Also named by AVAV, AYI, BA, HII, IONQ, KMB, LHX, NOC and 6 more
Third-party sterilization providers
depends onnamed as a riskIn some instances, only a few facilities are qualified under applicable regulations to conduct this sterilization.Risk factors (Item 1A)
Other companies
Waters Corporation
approximately $4 billionnamed as a riskA failure to complete the transaction, or a delay in doing so, could adversely impact our business, financial condition, results of operations and cash flows.Risk factors (Item 1A)
Also named by A
Edwards Lifesciences Critical Care product group
$3.914 billionThe fair value of consideration transferred in connection with the acquisition was $3.914 billion.Business (Item 1)
Product liability litigation (hernia, pelvic, vena cava filters, implantable ports, ethylene oxide)
named as a riskAlso, for certain product liability claims or lawsuits, BD does not maintain or has limited remaining insurance coverage, and we may not be able to obtain additional insurance on acceptable terms or at all that will provide adequate protection against potential liabilities.Risk factors (Item 1A)
Places
San Diego, California
operates innamed as a riskAs 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.Business (Item 1)
Commodities and inputs
Crude oil
exposed to its pricenamed as a riskIn addition to increased resin costs, any future increases in oil prices could also increase our packaging and transportation costs.Risk factors (Item 1A)
Also named by AESI, ALK, APA, ARLP, CFR, CL, CLMT, COP and 48 more
Resins
exposed to its pricenamed as a riskIn particular, we purchase supplies of resins, which are oil-based components used to manufacture certain products, and any significant increase in resin costs, whether due to inflationary pressure, increase in oil prices, supply constraints, regulatory changes or otherwise, could adversely impact future operating results.Risk factors (Item 1A)
Also named by BAX, CL, FBIN, ITW, JOUT, KVUE, PG, PPG and 2 more
Cobalt
depends onnamed as a riskTo the extent we or our third-party providers are unable to sterilize our products, whether due to lack of capacity, availability of materials for sterilization (including cobalt), regulatory requirements or otherwise, we may be unable to transition sterilization to other sites or modalities in a timely or cost-effective manner, or at all, which could have an adverse impact on our operating results and financial condition.Risk factors (Item 1A)
Ethylene oxide
depends onnamed as a riskEthylene 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.Business (Item 1)
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskWe are also currently operating under two warning letters issued by the FDA for our Dispensing and Specimen Management businesses.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
U.S. Environmental Protection Agency (EPA)
subject tonamed as a riskThere is increased focus on the use and emission of ethylene oxide by the U.S. Environmental Protection Agency (“EPA”) and state environmental regulatory agencies.Business (Item 1)
Also named by AAON, AAP, ALSN, AMRC, APA, APD, APG, AROC and 78 more
U.S. National Institutes of Health (NIH)
earns fromnamed as a riskA number of these customers are also dependent for their funding upon grants from U.S. government agencies, such as the U.S. National Institutes of Health and similar agencies in other countries.Risk factors (Item 1A)
December 2024 SEC Order
subject tonamed as a riskFurther, our ability to refinance our indebtedness could be adversely impacted by the loss of our “well-known seasoned issuer” status upon the filing of this annual report due to our entry into a December 2024 SEC Order.Risk factors (Item 1A)
Laws and programs
OECD Pillar Two global minimum tax
subject to · 15% global minimum taxnamed as a riskThe Organization for Economic Cooperation and Development published Pillar Two Model Rules, which impose a 15% global minimum tax, that became effective in some of the jurisdictions in which we operate in fiscal year 2025, and we continue to assess their impact.Risk factors (Item 1A)
Also named by ABNB, ACN, ADI, ADM, ADSK, AKAM, ALB, AMAT and 70 more
FDA Consent Decree (CareFusion 303, Inc. infusion pumps)
subject to · $15,000 per day per violation if we fail to comply with any provision of the Consent Decree, up to $15 million per yearnamed as a riskWe 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.Business (Item 1)
Also named by ABT
U.S. tariffs
subject tonamed as a riskBased upon the latest published tariffs that are currently in effect, we expect tariffs to adversely impact our operating expense for fiscal year 2026 and potentially beyond, primarily relating to any products (or components) imported from countries across our global supply chain, for which there are limited mitigation opportunities.Risk factors (Item 1A)
Also named by A, AAPL, ACHR, ADI, AEHR, AEP, AIOT, AKAM and 170 more
Medicare
earns fromnamed as a riskIn addition, we expect recently enacted and proposed changes under legislative debate to Medicare, Medicaid and the Affordable Care Act to impact healthcare coverage, all of which if implemented could adversely affect both the demand and prices customers are willing to pay for our products.Risk factors (Item 1A)
Also named by ABT, ARWR, AXGN, BAX, BMY, BSX, CAH, CDNA and 48 more
U.S. Foreign Corrupt Practices Act
subject tonamed as a riskFor example, such international operations are governed by the U.S. Foreign Corrupt Practices Act and similar foreign anti-corruption laws.Risk factors (Item 1A)
Also named by A, ADBE, ADP, AIR, AJG, ALB, AME, AMZN and 112 more
EU Medical Device Regulation (EU MDR)
subject tonamed as a riskComplying with and maintaining devices under these regulations requires us to incur significant expenditures.Risk factors (Item 1A)
Also named by ABBV, BAX, BSX, CAH, COO, DXCM, EW, GEHC and 4 more
China volume-based procurement (VoBP)
subject tonamed as a riskGlobally, governments in China and other countries continue to use various mechanisms to control healthcare expenditures, including increased use of competitive bidding and tenders, price regulation (such as volume-based procurement programs (“VoBP”)), government imposed payback provisions, and changes in reimbursement practices and policies on average selling prices for our products, which have unfavorably impacted our revenues and may continue to impact our results of operations in certain countries.Risk factors (Item 1A)
EU In Vitro Diagnostic Regulation (EU IVDR)
subject tonamed as a riskIn addition, the European Union (“EU”) has adopted the EU Medical Device Regulation (Regulation (EU) 2017/745, the “EU MDR”) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, the “EU IVDR”), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evidence, quality management systems and post-market surveillance.Risk factors (Item 1A)
Section 232 investigation on medical devices (Trade Expansion Act of 1962)
subject tonamed as a riskFurther, the U.S. Department of Commerce recently initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, into (among other things) imports of personal protective equipment, medical consumables and medical equipment (including devices), to determine whether they threaten U.S. national security, which further creates policy uncertainty in terms of tariffs.Risk factors (Item 1A)
Also named by EW
CMS Competitive Bidding Program
subject tonamed as a riskIn the U.S., the Center for Medicaid Services (“CMS”) has proposed the expansion of its Competitive Bidding Program (“CBP”).Risk factors (Item 1A)
Also named by BAX
FDA Dispensing Warning Letter (BD Pyxis)
subject tonamed as a riskOn 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 PyxisTM products (“Dispensing Warning Letter”).Business (Item 1)
EPA NESHAP Ethylene Oxide Emissions Standards for Sterilization Facilities
subject tonamed as a riskWe implemented certain changes to our facilities in accordance with NESHAP’s requirements in 2024 and 2025 and are in the process of implementing certain additional changes to our facilities to achieve compliance with such requirements by April 2028.Risk factors (Item 1A)
EPA Interim Registration Review Decision for Ethylene Oxide
subject tonamed as a riskWe expect to implement certain changes at our facilities to comply with NESHAP and ID requirements, which will require us to incur additional implementation and ongoing operating costs.Risk factors (Item 1A)
Technology
GLP-1 medications
competes withnamed as a riskIn some instances, competitors, including pharmaceutical companies, also offer (or are attempting to develop) alternative therapies for disease states that may be delivered without a medical device, such as oral GLP-1 medications.Risk factors (Item 1A)
BD Alaris Infusion System
named as a riskThe overall timing and cost of replacement or remediation 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.Risk factors (Item 1A)