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Item 1A. Risk Factors
There have been no material changes to the risk factors previously disclosed in Part I, Item 1A, of our 2024 Annual Report or our subsequent Quarterly Reports on Form 10-Q, other than as set forth below:
Our international operations subject us to certain business risks.
A substantial amountThe proposed combination of our sales come from our operaBiosciences and Diagnostic Solutions outside the U.S., and we intend to continue to pursue growth opportunities in foreign markets, especibusiness with Waters may not be completed, on the currently contemplated timeline or at ally in emerging markets. Our foreign operations subject us to certain commercial, pol.
On July 13, 2025, we entered into a definitical and financial risks. In addition to fluctuations in foreign currve agreement with Waters to combine our Biosciency exchange (discussed above), oures and Diagnostic Solutions business in these foreign markets is subject to changing political, social, and geopoliticalwith Waters. The transaction, if conditions, such as the evolving situationssummated, would result in Ukraine, the Middle East and Asia. Theseour shareholders owning approximately 39.2% of the conditions include instability resultimbined company, and existing from war, Waterrorism, insurrections and civil unrest, political conflict, ans shareholders owning approximately 60.8% of the combined changing economic conditions, such as inflation, deflation, intereompany. The transaction is expected to close around the end of the first rate volatility and credit availability.
Specifically, recently enacted tariffs by the U.S. government (and countermeasures by non-U.S. governments) may result in adverse impacts to the global economic environquarter of calendar year 2026, subject to receipt of required regulatory approvals, Waters shareholder approval, compliance with applicable SEC requirement and s, the stabilityreceipt of the global financial markets, which could significantly reduce global trade and, in particular, trade between the impacted countries. The tariffs, sanctions or other trade barriers imposed by the U.S. or against ta private letter ruling from the Internal Revenue Service regarding certain matters germane to the U.S. from otherederal income tax countrinsequences could adversely impof the transact our supply chain costs or availabilityions, and satisfaction of certainother customary closing components and our business operations, financialnditions. There can be no assurance that such closing condition or results of operations. In the longer-term,s will be satisfied or waived, or that the adverse imptransacts from tariffs to our results of operations within certain markets may negatively impact ouion will be consummated, on the currently contemplated timeline or abilityt all. A failure to continue operating in those markets, particularlmplete the transaction, or a delay in China. The ultimatedoing so, could adversely impact of any existing or new tariffs on our business, results of operations, financial condition and cash flows is subject to a number of factors including, but not limited to, t. In the event that the duration of such tariffs, changtransaction does in tariff rates, the scope and nature of the tariffs, any countermeasures that targetnot close, we will be required to bear significant non-recurring countries may take, or any mitigating asts in connections that may become available. While sourcing optimization and tariff exemp with the transaction.
The announcement and pendency of the combinations for qualifying product of our Biosciences are key aspects of our mitigation strnd Diagnostic Solutions business with Wategy, the timing of such or the ultimate results we will realize fromrs could cause disruptions in our business.
The completion of these efforts are uncertain.
Addi separationally, a number of other factors, including U.S. relaur Biosciences and Diagnostic Solutions with or among business and combination of the governments of the foreign cbusiness with Waters will require significant amountries in s of time and effort, which we operate, changes to internacould divert management attentional trade agreements and treaties, changes in tax laws, could disrupt the activities of our employees, and regulations, economic sanccould have negative implications, export controls, for our restrictilations on the ability to transfer capital across bordhips with our customers, and other increases in trade protthird parties. We
expectionism to incur costs and barriers to market participaexpenses in connection, or with the weakening or loss of certain intellectual property rights in somseparation and combination. Until the countries, may affect our business, fnsummation or terminancial condition and results of operathe transactions. Foreign regulatory, we are also requirements, including those reld to operated to t the testing, authorization,business in the ordinary course and labeling of products and import or export licensing requirements, coulwe are restricted from taking certain specified affect the availability ofctions with respect to our products in these markets. In addition to these broader market condiBiosciences and Diagnostic Solutions, our operati business without Waters cons may also be impacted by a variety of local factors, such as competition from local companies, locent. Any of the foregoing could adversely affect our business, results of operations, financial product preferencescondition and requirements, changes in local healthcare payment systems and healthcare delivery systems, changes resulting from new political administrcash flows.
We may not realize some or all of the expected benefits of the combinations, and labor force instability.
The success of our opera of our Biosciences and Diagnostic Solutions outside the U.S. also depends, in business with Waters.
If the separt, ation of our ability to make neBiosciencessary infrastructure enhancements to, among o and Diagnostic Solutions business and combination of ther things, our production facilities and sales and distribution networks and manag business with Waters is completed, the and staff widespread internticipated operational operations. These, financial, strategic and other factors may adversely impact our ability to pursue benefits of such transaction to BD and our growth strategy in these markets.
shareholders may not be achieved. In addition, our international operations are governed by the U.S. Foreign Corrupt Practices Act and similar foreign anti-corrupwe have agreed to provide certain transition laws. Global enforcement of anti-corruption laws has increased substantially in recent yearsservices to the combined company, withich more enforcement proceedings by U.S. and foreign governmentay result in additional agenciexpenses and the imposition of significant finemay divert our focus and penalties. While we have implemenresources that would otherwise be invested policies and procedures relating to compliance with these laws, into maintaining or growing our international operations, which ofbusinesses. An inability to realize the full exten involve customer relationships with foreign governments, createt of the anticipated benefits of the risk that there may be unauthoriztransaction, as well as any delays encountered payments or offers of payments made by employees, consultants, sales agenin the process, could have an adverse effect on our business, results or distributors. We are also subject to certain U.S. f operations, financial condition and foreign laws and regulacash flows. In additions that restrict BD from, while it is expected that the transacting business with, on would be generally tax-free for making investmentsU.S. federal in, certain countries, governments, entities come tax purposes to BD and individuals subject to U.S. or foreign economic sour shareholders, there is no assuranctions or export restrie that the transactions. Any alleged or act will qual violations ofify for these laws may subject us to government investigais treatment. If the transactions and significant cri is ultimately determinal or civil sanctions and other ed to be taxable, we could incur income tax liabilities, and negatively affect our reputation and that could be significant. Any of the foregoing could result in a material aadverse ely affect on our business, results of operations, financial condition and cash flows.
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