Embecta Corporation

02/05/2026 | Press release | Distributed by Public on 02/05/2026 10:26

Quarterly Report for Quarter Ending December 31, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.
Certain Factors Affecting Forward-Looking Statements
The following discussion and analysis should be read in conjunction with the Condensed Consolidated Financial Statements and accompanying notes contained elsewhere in this Quarterly Report on Form 10-Q. This discussion contains a number of forward-looking statements, all of which are based on our current expectations and could be affected by the uncertainties and other factors described throughout this discussion and analysis, particularly in the section "Cautionary Statement Concerning Forward-Looking Statements."
Company Overview
We are a leading global medical device company focused on providing solutions to improve the health and well-being of people living with diabetes. In the over 100-year history of our business, we believe that our products have become some of the most widely recognized and respected brands in diabetes management in the world. We estimate that our products are used by approximately 30 million people in over 100 countries for insulin administration and to aid with the daily management of diabetes. Our business traces its origins to 1924, when BD developed the first dedicated insulin syringe. Since then, we have built a world-class organization with a unique manufacturing, supply chain and commercial footprint.
We have a broad portfolio of marketed products, including a variety of pen needles, syringes and safety injection devices. Our pen needles are sterile, single-use, medical devices, designed to be used in conjunction with pen injectors that inject insulin or other diabetes medications. We also sell safety pen needles, which have shields on both ends of the cannula that automatically deploy after the injection to help prevent needlestick exposure and injury during injection and disposal. Our traditional and safety pen needles are compatible and frequently used with widely available pen injectors in the market today. In addition to pen needles, we sell sterile, single-use insulin syringes, which are used to inject insulin drawn from insulin vials. We also sell safety insulin syringes, which have a sliding safety shield that can be activated with one-hand after the injection to help prevent needlestick exposure and injury during injection and disposal.
We primarily sell our products to wholesalers and distributors that sell to retail and institutional channels who in turn sell to patients or use the products to deliver insulin injections to patients.
Key Trends Affecting Our Results of Operations
Competition. The regions in which we conduct our business and the medical devices industry in general are highly competitive. We face significant competition from a wide range of companies in a highly regulated industry. These include large companies with multiple product lines, some of which may have greater financial and marketing resources than us, as well as smaller more specialized companies. Non-traditional entrants, such as technology companies, are also entering into the diabetes care industry and its adjacent markets, some of which may have greater financial and marketing resources than us.
Pricing Pressures. We face significant pricing pressures from competitors in the pen needle and insulin syringe categories who not only can provide competitive products at lower costs, but also provide payors and customers with more choices for formulary partners in these categories. In addition, the increased scrutiny by regulators on healthcare spending, which accelerated in light of the COVID-19 pandemic, along with a shift towards volume-based procurement and group purchasing organizations, which generally values lower cost over product features, benefits and quality, have placed significant pressure on Embecta to lower price in both developed and emerging markets. These trends may reduce our operating margins, which are only partially offset by our ability to differentiate our products and sell at higher prices.
Commoditization of Injection Devices. Given the growing demand for medical devices to assist in the treatment of diabetes and difficulties around access to diabetes care due to complex and costly insurance plans, patient care is increasingly focused on providing more affordable products, which has led to the commoditization of more traditional injection delivery devices, such as insulin syringes and pen needles. Existing and new local and regional low-cost providers, in combination with a shift from insulin vials to insulin pens, have made the pen needle category highly competitive.
Global Trade. The current global economic environment has been recently influenced by rapidly changing new tariff policies instituted by the United States government and foreign governments. As a global company that both imports raw materials and products into the U.S. and distributes raw materials and products originating from the U.S. to global manufacturing sites and markets, these new tariffs may have a financial impact on our cost of goods, our profit margins, our business generally and our global distribution strategy. These new tariffs may cause foreign governments and private purchasers to consider transitioning away from products originating from certain countries (including the U.S.) in favor of buying "local" products resulting in the additional possibility that local manufacturers, brands and other competitors may engage in aggressive competitive pricing to take advantage of the uncertain global trade environment and transition customers away from global manufacturers, all of which may impact the Company's business and operations.
Dollar amounts are in millions except per share amounts or as otherwise specified.
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Changes in Clinical Practice. Introduction of new drugs and increased penetration of oral and once-weekly anti-diabetic drugs (e.g., SGLT-2s, once-weekly insulin, GLP-1s and GLP-1 combination products) have delayed initiation of insulin therapy and contributed to less demand for our products. New drug therapies, including weekly insulin, are targeted to challenge the current diabetes treatment paradigm, including the frequency insulin is dosed (weekly vs. daily injections) and amount of insulin used. Additionally, insulin therapy in developed markets continues to transition to infusion pumps.
Decentralization of Chronic Care. Many countries are facing an aging population and a rapidly growing number of people living with diabetes. While healthcare investments in certain regions continue to grow, there is an increased burden on physicians and longer wait times for patients. Healthcare delivery for non-emergency diabetes care is expected to continue shifting outside of hospitals to primary care providers, which could have a material impact on our results of operations.
Political and Economic Instability in Emerging Markets. We operate in a number of emerging markets, many of which are subject from time to time to significant political and economic disruptions. However, the number of countries we provide products to and our proactive channel management strategies help us manage this variability.
Recent Developments
We continue to face increases in the cost and disrupted availability of raw materials, components, and other inputs necessary to manufacture and distribute our products due to constraints and inflation within the global supply chain, as well as increases in the cost and time to distribute our products. To date we have been able to successfully mitigate this disruption and provide uninterrupted supply to our customers by increasing our inventory levels and taking other measures. Given our global business, we expect recently announced tariffs will result in additional cost for us and our suppliers, and there is the potential that such tariffs may influence future decisions by foreign governments and private purchasers to source non-U.S., "locally" manufactured products instead of products originating from certain countries (including the U.S.) and that local manufacturers, brands and other competitors may engage in aggressive competitive pricing or other strategies to take advantage of the uncertain global trade environment and transition customers away from global manufacturers. We will continue to monitor the evolving tariff environment and we will focus on optimizing operations and leveraging existing strategies to reduce the impact from tariffs.
We continue to monitor the conflict in Ukraine and the associated sanctions and other restrictions. We also are monitoring the conflicts in the Middle East and Houthi attacks on commercial shipping vessels and other naval vessels. As of February 5, 2026, there is no material impact to our business operations and financial performance as a result of the aforementioned conflicts. However, the full impact of the conflicts on our business operations and financial performance remains uncertain and will depend on future developments, including the severity and duration of the conflicts and their impact on regional and global economic conditions. We will continue to monitor these conflicts and assess the related restrictions and other effects on our business.
In addition, our revenues and results of operations have been affected by various fluctuations in macroeconomic conditions and regulatory and policy changes, both on a global level and in particular markets, which include inflation and slowing economic growth and contractions, a changing interest rate environment, supply chain interruptions, tariff policy changes, volatility in capital markets and the availability of credit, tax rates and the rate of exchange between the United States dollar and foreign currencies. The nature and extent of the impact of these factors among others varies by region and remains uncertain and unpredictable and may affect our business.
Dollar amounts are in millions except per share amounts or as otherwise specified.
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Results of Operations
Our unaudited Condensed Consolidated Statements of Income are as follows:
Three months ended December 31,
2025 2024
%
Revenues $ 261.2 $ 261.9 (0.3) %
Cost of products sold 99.5 104.8 (5.1)
Gross Profit 161.7 157.1 2.9
Operating expenses:
Selling and administrative expense 77.6 81.1 (4.3)
Research and development expense 4.6 20.3 (77.3)
Other operating (income) expense, net (3.8) 27.0 (114.1)
Total Operating Expenses 78.4 128.4 (38.9)
Operating Income 83.3 28.7 190.2
Interest expense, net (24.1) (27.9) (13.6)
Other income (expense), net (0.3) (1.5) (80.0)
Income (Loss) Before Income Taxes 58.9 (0.7) *
Income tax provision (benefit) 14.8 (0.7) *
Net Income $ 44.1 $ - *
Net Income per common share:
Basic $ 0.75 $ - *
Diluted $ 0.74 $ - *
* = not meaningful
Three Months Ended December 31, 2025 Summary (on a comparative basis)
Key financial results for the three months ended December 31, 2025 were as follows:
•Revenue decreased by $0.7 million to $261.2 million from $261.9 million;
•Gross profit increased by $4.6 million to $161.7 million from $157.1 million. Gross profit as a percent of revenue was 61.9%, as compared to 60.0% in the prior year comparative period;
•Operating income increased by $54.6 million to $83.3 million from $28.7 million; and
•Net income increased by $44.1 million to $44.1 million from $0.0 million.
Revenues
The Company's revenues decreased by $0.7 million, or 0.3%, to $261.2 million for the three months ended December 31, 2025 as compared to revenues of $261.9 million for the three months ended December 31, 2024. Changes in revenues are driven by the volume of goods that the Company sells, the prices it negotiates with customers, and changes in foreign exchange rates. The decrease in revenues was driven by $7.8 million of unfavorable changes in price and a $0.7 million decrease in contract manufacturing revenues related to sales of non-diabetes products to BD, partially offset by $4.6 million associated with the positive impact of foreign currency translation primarily due to the weakening of the U.S. dollar and $3.2 million of favorable changes in volume.
Dollar amounts are in millions except per share amounts or as otherwise specified.
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Cost of products sold
Cost of products sold decreased by $5.3 million, or 5.1%, to $99.5 million for the three months ended December 31, 2025 as compared to $104.8 million for the three months ended December 31, 2024. Cost of products sold as a percentage of revenues was 38.1% for the three months ended December 31, 2025 as compared to 40.0% for the three months ended December 31, 2024. The decrease in cost of products sold for the three month comparative period was primarily driven by impairment charges recorded in the prior period to write down the carrying value of certain property and equipment with no comparable impairment charges in the current period.
Selling and administrative expenses
Selling and administrative expenses decreased by $3.5 million, or 4.3%, to $77.6 million for the three months ended December 31, 2025 as compared to $81.1 million for the three months ended December 31, 2024. The decrease for the three month comparative period was primarily driven by lower compensation expense in the current period.
Research and development expenses
Research and development expenses decreased by $15.7 million, or 77.3%, to $4.6 million for the three months ended December 31, 2025 as compared to $20.3 million for the three months ended December 31, 2024. The decrease for the three month comparative period was primarily driven by expenses incurred in connection with the development of our insulin patch pump program in the prior year before the decision was made to discontinue the program. There were no comparable expenses associated with the patch pump program in the current year.
Other operating (income) expense, net
Other operating (income) expense, net are as follows:
2025 2024
Costs related to the Separation $ 3.1 $ 10.4
Amortization of cloud computing arrangements
2.6 2.5
Costs associated with the discontinued patch pump program - 14.3
Gain on sale of certain intellectual property rights and long-lived assets (10.1) -
Other 0.6 (0.2)
Total $ (3.8) $ 27.0
Other operating (income) expense, net incurred primarily consist of the following:
•Accounting, auditing, legal services, marketing, supply chain, employee retention, costs associated with the implementation of our new ERP system and other Business Continuity Processes, costs associated with brand transition, and certain other costs to establish certain stand-alone functions to assist with the transition to being a stand-alone entity;
•Severance and contract termination costs associated with the discontinued patch pump program;
•Costs recognized associated with the amortization of cloud computing arrangements; and
•A gain on the sale of certain intellectual property rights and long-lived assets associated with the patch pump program.
Interest expense, net
Interest expense, net decreased by $3.8 million to $24.1 million for the three months ended December 31, 2025 as compared to $27.9 million for the three months ended December 31, 2024. The decrease for the three month comparative period was primarily driven by lower debt levels and lower short-term interest rates in the current period as compared to the prior period. It remains unclear whether the United States Federal Reserve will increase or decrease the benchmark interest rate during the remainder of fiscal 2026. An increase in the benchmark interest rate would result in an increase in interest expense on our variable rate debt and a decrease in the benchmark interest rate would result in a decrease in interest expense on our variable rate debt.
Dollar amounts are in millions except per share amounts or as otherwise specified.
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Other income (expense), net
Other income (expense), net was $(0.3) million and $(1.5) million for the three months ended December 31, 2025 and 2024, respectively. Other income (expense), net did not materially change in the current period as compared to the prior year period.
Income tax provision (benefit)
The effective tax rates were 25.1% and 100.0% for the three months ended December 31, 2025 and 2024, respectively. The decrease in the Company's effective tax rate compared to the prior period is primarily due to the level and mix of earnings, lower limitations on the deductibility of interest expense in the U.S. and lower U.S. tax on foreign earnings.
LIQUIDITY AND CAPITAL RESOURCES
We believe that our cash and our cash equivalents and cash from operations, together with our borrowing capacity under our Revolving Credit Facility, will provide sufficient financial flexibility to fund seasonal and other working capital requirements, capital expenditures, debt service requirements and other obligations, cash dividends on common shares and additional growth opportunities for the foreseeable future. However, should it become necessary, we believe that our credit profile should provide us with access to additional financing in order to fund normal business operations, make interest payments, fund growth opportunities and satisfy upcoming debt maturities.
The following is a summary of Embecta's total debt outstanding as of December 31, 2025:
Term Loan $ 679.3
5.00% Notes
500.0
6.75%Notes
200.0
Total principal debt issued $ 1,379.3
Less: current debt obligations (9.5)
Less: debt issuance costs and discounts (16.9)
Long-term debt $ 1,352.9
The schedule of principal payments required on long-term debt for the next five years and thereafter is as follows:
2026 $ 7.1
2027 9.5
2028 9.5
2029 653.2
2030 700.0
Thereafter -
Certain measures relating to our total debt outstanding as of December 31, 2025 were as follows:
Total debt $ 1,362.4
Short-term debt as a percentage of total debt 0.7 %
Weighted average cost of total debt 6.1 %
The credit agreement and the indentures for the 5.00% Notes and the 6.75% Notes contain customary financial covenants, including a total net leverage ratio covenant, which measures the ratio of (i) consolidated total net debt to (ii) consolidated earnings before interest, taxes, depreciation and amortization, and subject to other adjustments, must meet certain defined limits which are tested on a quarterly basis in accordance with the terms of the credit agreement and indentures governing the 5.00% Notes and the 6.75% Notes. In addition, the credit agreement contains covenants that limit, among other things, our ability to prepay, redeem or repurchase our subordinated and junior lien debt, incur additional debt, make acquisitions, merge with other entities, pay dividends or distributions, redeem or repurchase equity interests, and create or become subject to liens. As of December 31, 2025, we were in compliance with all of such covenants. The credit agreement and the senior secured notes are secured by substantially all assets of Embecta and each subsidiary guarantor, subject to certain exceptions.
Dollar amounts are in millions except per share amounts or as otherwise specified.
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During the three months ended December 31, 2025, the Company paid an aggregate principal amount of approximately $37.5 millionon the Term Loan, of which $35.1 millionwas discretionary. Debt extinguishment charges as a result of these discretionary prepayments were not material to the Company's Condensed Consolidated Statements of Income.
During the three months ended December 31, 2025, the Company made interest payments of $13.2 million on debt outstanding.
We may, from time to time, seek to retire or repurchase our outstanding debt through cash purchases and/or exchanges for equity or debt, in open-market purchase, or privately negotiated transactions, or otherwise may redeem some or all of our debt pursuant to its terms. Such repurchases or exchanges, if any, will depend upon various factors existing at the time, including prevailing market conditions, our liquidity requirements, contractual restrictions and other factors,and there can be no assurance as to which, if any, of these alternatives, or combination thereof, we may choose to pursue in the future.
For additional information related to the Company's debt related activities, refer to Note 12 within the Notes to Condensed Consolidated Financial Statementswithin this Form 10-Q.
Leases
Maturities of our finance lease and operating lease liabilities as of December 31, 2025 by fiscal year are as follows:
Finance Lease Operating Leases Total
2026 $ 2.8 $ 4.5 $ 7.3
2027 3.8 2.7 6.5
2028 3.9 2.1 6.0
2029 3.9 2.2 6.1
2030 4.0 1.8 5.8
Thereafter 28.3 5.7 34.0
Total lease payments $ 46.7 $ 19.0 $ 65.7
For additional information related to our leases, refer to Note 18 within the Notes to Condensed Consolidated Financial Statements of this Form 10-Q.
Receivables Sale Agreement
The Company has established a trade receivables sale agreement with a third-party financial institution to sell certain trade receivables of the Company at a discount on an uncommitted basis. These trade receivable sales are accounted for as a sale of assets, as the Company's continuing involvement is limited to servicing the accounts receivables. The Company receives the sales price, equal to the trade receivable less the applicable discount, at the time of sale.
In connection with the Company's receivables sale agreement, $56.0 million of trade receivables were sold during the three months ended December 31, 2025, resulting in derecognition of the receivables from the Company's Condensed Consolidated Balance Sheets. Discounts recognized on the sale of trade receivables were not material to the Company's Condensed Consolidated Statements of Income. The cash received on the sale of trade receivables during the three months ended December 31, 2025 is presented in changes in trade receivables, net within operating activities in the Condensed Consolidated Statement of Cash Flows.
Access to Capital and Credit Ratings
In May 2025 and January 2026, Moody's Investor Services and Standard & Poor's Ratings Services published updates and reaffirmed our preexisting credit ratings. Our Moody's Investors Services credit rating is B1 and our Standard & Poor's Rating Services credit rating is B+.
Dollar amounts are in millions except per share amounts or as otherwise specified.
25
Cash and equivalents and restricted cash were $204.4 million as of December 31, 2025 as compared to $228.6 million as of September 30, 2025.
The primary uses of cash that contributed to the $24.2 million decrease were:
September 30, 2025 Cash and equivalents and restricted cash balance $ 228.6
Cash provided by operating activities 17.2
Cash provided by investing activities 9.5
Cash used for financing activities (51.6)
Effect of exchange rate changes on cash and equivalents and restricted cash 0.7
December 31, 2025 Cash and equivalents and restricted cash balance $ 204.4
Net cash provided by operating activities was primarily attributable to:
Net Income $ 44.1
Adjustments related to depreciation and amortization, impairment of property, plant and equipment, gain on sale of certain intellectual property rights and long-lived assets, stock-based compensation, and deferred income taxes 14.0
Change in accounts payable and accrued expenses
(23.8)
Change in trade receivables
(12.0)
Change in inventories
(3.5)
Change in amounts due from/due to Becton, Dickinson and Company
-
Change in prepaid expenses and other
2.0
Change in income and other net taxes payable
(1.8)
Change in other assets and liabilities, net
(1.8)
Net cash provided by operating activities $ 17.2
The change in accounts payable and accrued expenses is primarily attributed to timing of payments to vendors and annual bonus payments.
The change in trade receivables is primarily attributed to the timing of sales and receivables factored.
The change in inventories is primarily attributed to timing of purchases, production, and sales of our inventories.
Certain amounts previously presented within Amounts due from Becton, Dickinson and Company and Amounts due to Becton, Dickinson and Company are presented within Trade receivables, net and Accounts Payable, respectively, beginning October 1, 2025 within the Condensed Consolidated Balance Sheets. Changes in working capital associated with the agreements referenced in Note 3 to the Condensed Consolidated Financial Statements are reflected within the change in trade receivables and accounts payable and accrued expenses, respectively.
The change in prepaid expenses and other is primarily attributed to timing of payments to vendors.
The change in income and other net taxes payable is primarily attributed to timing of required tax payments.
The change in other assets and liabilities, net is primarily attributed to costs capitalized attributed to cloud computing arrangements.
All other movements related to working capital were due to timing of payments and receipts of cash in the ordinary course of business.
Net cash provided by investing activities for the three months ended December 31, 2025 was comprised of proceeds from the sale of certain intellectual property rights and long-lived assets of $10.1 million offset by capital expenditures of $0.6 million to support our business and operations.
Dollar amounts are in millions except per share amounts or as otherwise specified.
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Net cash used for financing activities was primarily attributable to:
Dividend payments $ (8.9)
Payments on long-term debt (37.5)
Payments related to tax withholding for stock-based compensation (4.8)
Payments on finance lease (0.4)
Net cash used for financing activities $ (51.6)
Contractual Obligations
Our contractual obligations as of December 31, 2025, which require material cash requirements in the future, consist of purchase obligations and lease obligations. Purchase obligations are enforceable and legally binding obligations for purchases of goods and services which include inventory purchase commitments. Over the next several years, we expect to incur material costs associated with operating and maintaining our information technology infrastructure. Lease obligations include lease agreements for which a contract has been signed even if the lease has not yet commenced. Refer to "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" in the 2025 Form 10-K for further details. As of December 31, 2025, there have been no material changes to our contractual obligations outside the ordinary course of business.
Critical Accounting Policies
Our significant accounting policies, which include management's best estimates and judgments, are included in Note 2 to the Consolidated Financial Statements included in the 2025 Form 10-K. A discussion of accounting estimates considered critical because of the potential for a significant impact on the financial statements due to the inherent uncertainty in such estimates are disclosed in the Critical Accounting Policies section of Management's Discussion and Analysis of Financial Condition and Results of Operations included in the 2025 Form 10-K. There have been no changes to our critical accounting policies as of December 31, 2025.
Cautionary Statements Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains statements that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995 and other securities laws. Forward-looking statements include those containing such words as "anticipates," "believes," "can," "could," "estimates," "expects," "forecasts," "goal," "guidance," "intends," "may," "outlook," "plans," "possible," "projects," "seeks," "sees," "should," "targets," "will," "would," or other words of similar meaning. All statements that reflect Embecta's expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, forecasts relating to discussions of future operations and financial performance (including volume growth, pricing, sales and earnings per share growth and cash flows) and statements regarding Embecta's strategy for growth, the Patch Pump Restructuring Plan, the 2025 Restructuring Plan, expectations related to the impact of incremental tariffs, brand transition, future product development, anticipated product and regulatory clearances, approvals, and launches, competitive position and expenditures. Forward-looking statements are based upon our present intent, beliefs or expectations, are not guarantees of future performance and are subject to numerous risks, uncertainties, and changes in circumstances that are difficult to predict. Although Embecta believes that the expectations reflected in any forward-looking statements it makes are based on reasonable assumptions, it can give no assurance that these expectations will be attained and it is possible that actual results may differ materially from those indicated by these forward-looking statements due to a variety of risks and uncertainties. Such risks and uncertainties include, but are not limited to:
•Competitive factors that could adversely affect Embecta's operations, including adoption of new drug therapies for treatment of diabetes, new product introductions by Embecta's competitors, the development of new technologies, lower cost producers that create pricing pressure, and consolidation resulting in companies with greater scale and market presence than Embecta.
•The risk that Embecta is unable to replace the services, including the Business Continuity Processes, that BD currently provides to it on substantially similar terms as the terms on which BD is providing these services under the transaction agreements or that BD terminates such services.
•Any failure by BD to perform its obligations under the various separation agreements entered into in connection with the Separation and distribution, including the cannula supply agreement.
•Any events that adversely affect the sale or profitability of one of Embecta's key products or the revenue delivered from sales to its key customers.
Dollar amounts are in millions except per share amounts or as otherwise specified.
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•Increases in operating costs, including costs incurred from the new tariffs instituted by the U.S. government and certain foreign governments on raw materials and products, fluctuations in the cost and availability of oil-based resins, other raw materials, and energy as well as certain components, used in its products, the ability to maintain favorable supplier arrangements and relationships, and the potential adverse effects of any disruption in the availability of such items.
•The risk that as a result of the current global trade environment from the newly instituted tariffs, certain foreign governments, private purchasers and other customers in certain countries may consider transitioning away from products originating from certain countries (including the U.S.) in favor of buying "local" products and local manufacturers and competitors may attempt to capitalize on these sentiments and participate in aggressive competitive pricing or other strategies to transition, or divert, current and potential customers away Embecta.
•Embecta's ability to obtain clearance from the U.S. Food and Drug Administration of any product, to market and sell such products successfully, to anticipate the needs of people with diabetes, and future business decisions by Embecta and its competitors.
•Changes in reimbursement practices of governments or private payers or other cost containment measures.
•The adverse financial impact resulting from unfavorable changes in foreign currency exchange rates, as well as regional, national and foreign economic factors, including inflation, deflation, and fluctuations in interest rates, and their potential effect on its operating performance.
•The impact of changes in United States, federal laws and policy that could affect fiscal and tax policies, healthcare and international trade, including import and export regulation, tariffs and international trade agreements. In particular, tariffs or other trade barriers imposed by the United States or other countries could adversely impact its supply chain costs or otherwise adversely impact its results of operations.
•Any future impact of pandemics or geopolitical instability on Embecta's business, including disruptions in its operations and supply chains.
•New or changing laws and regulations affecting Embecta's domestic and foreign operations, or changes in enforcement practices, including laws relating to healthcare, environmental protection, trade, monetary and fiscal policies, taxation (including tax reforms that could adversely impact multinational corporations) and licensing and regulatory requirements for products.
•The expected benefits of the Separation from BD.
•Risks associated with indebtedness and our use of indebtedness available to us.
•The risk that dis-synergy costs, costs of restructuring transactions and other costs incurred in connection with the Separation will exceed Embecta's estimates.
•The impact of the Separation on Embecta's businesses and the risk that the Separation, including brand transition timelines and efforts, may be more difficult, time-consuming or costly than expected, the impact on its resources, systems, including ERP, procedures and controls, diversion of management's attention and the impact on relationships with customers, suppliers, employees and other business counterparties.
•Embecta's ability to timely and successfully complete the brand transition, including any resulting regulatory delays of transferring or obtaining registrations and licenses in the "Embecta" name, interruptions in, or customer confusion from, the replacement and transfer of the rebranded product into the current commercialization, supply and distribution networks, or other issues arising out of system, supply chain logistics, administrative and adjudicative operations transitions in the end-to-end product flow and end-user access.
•The expectations related to the costs, profitability, timing and the estimated financial impact of, and charges associated with, the Patch Pump Program Restructuring Plan and the 2025 Restructuring Plan.
•The risk that we may not complete strategic collaborative partnerships and acquisition opportunities that enable us to accelerate our growth or strategic collaborative opportunities that give us access to innovative technologies, complementary product lines, and new markets.
There can be no assurance that the transactions or uncertainties described above will in fact be consummated or occur in the manner described or at all. As a result, you should not place undue reliance upon our forward-looking statements. The above list of factors is not exhaustive or necessarily in order of importance. For additional information on identifying factors that may cause actual results to vary materially from those stated in forward-looking statements, see the discussions under "Risk Factors," included within the 2025 Form 10-K. Any forward-looking statement speaks only as of the date on which it is made, and Embecta expressly disclaims and assumes no obligation to update or revise such statement, whether as a result of new information, future events or otherwise, except as required by applicable law.
Dollar amounts are in millions except per share amounts or as otherwise specified.
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