EMBC 10-K & 10-Q changes, risk factors and insider trading
Embecta Corp. · Nasdaq · Surgical & Medical Instruments & Apparatus · CIK 1872789 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Trade actions, such as tariffs, retaliatory tariffs, and private or governmental "buy local" initiatives could adversely and unexpectedly impact our business.”
New heading “Changes in government funding for the FDA and other government agencies could affect their ability to obtain and retain key resources and personnel, properly administer medical device innovation, or prevent Embecta’s products from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing routine business functions on which the operation of Embecta’s business relies, which could adversely affect its business.”
Removed heading “The closing of the Separation was deferred in certain jurisdictions, and may not occur at all in such jurisdictions, due to local regulatory requirements, which may adversely affect Embecta’s business, financial condition and results of operations.”
Removed heading “If our remedial measures are insufficient to address material weaknesses in our internal control over financial reporting, our ability to report financial information could be adversely affected, it could result in a material misstatement in our financial statements not being prevented or detected, it could harm our business, it could cause investors to lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock may decline.”
Largest changes
“The use of tariffs as a policy tool has created significant uncertainty about the future trading relationship among the U.S., China, the European Union, Canada, Mexico and other exporting countries, including with respect to trade policies, treaties, government regulations and tariffs, and has led to concerns regarding the potential for extended trade barriers. …”see in full comparison
Embecta’s operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), import and export control, product safety and efficacy, employment,see in full comparisonprivacy,privacy and cybersecurity, financial transparency, conflict minerals and other areas. Violations of these laws can result in criminal or civil sanctions, including substantial fines and, in some cases, exclusion from participation in healthcare programs such as Medicare and Medicaid. Environmental laws, particularly with respect to the emission of greenhouse gases, such as taxes on fuel and energy, to mitigate the impacts of climate change, are becoming more stringent throughout the world, including tightening emissions standards, which may increase Embecta’s costs of operations or necessitate closures of or changes to its manufacturing plants or processes or those of its suppliers, or result in liability to Embecta.EmbectaForisexample,alsoEmbecta’s operations and facilities may become subject tovariousformal or informal scrutiny, audit, or enforcement actions or proceedings for noncompliance with environmental laws related to substances released into the environment. Such matters are typically resolved with regulatory authorities through commitments to compliance, abatement, or remediation programs, and, in some cases, payment of penalties or fines. The U.S. and international governments have increasingly been regulating perfluorooctane sulfonate, perfluorooctanoic acid, and/or other per- and poly-fluoroalkyl substances. These regulationsrelatinginclude tightening emission standards and limits as to thesafetypresence of certain compounds. As a result of uncertainties associated with environmental regulations andeffectivenessrequired remediation activities, costs incurred to maintain our compliance or resolve or remediate any identified issues could have an adverse effect on our business, results ofmedical devices, including relating to design, developmentoperations andmanufacturing,cashproduct traceability and record keeping procedures, product complaints, complaint reporting, recalls and field safety corrective actions, advertising and promotion and clinical trials and post-market studies with respect to its products. Failure to comply with these laws may result in enforcement actions by the FDA or other similar regulatory agencies and other liability to Embecta. The enactment of additional laws or changes in existing laws may increase compliance costs or otherwise adversely impact Embecta’s operations.flows.
“If our remedial measures are insufficient to address material weaknesses in our internal control over financial reporting, our ability to report financial information could be adversely affected, it could result in a material misstatement in our financial statements not being prevented or detected, it could harm our business, it could cause investors to lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock may decline.”see in full comparison
“The current tariff environment evolves continuously and is uncertain. The United States has imposed tariffs and export controls on certain goods and products imported from China and certain other countries, which has resulted in retaliatory tariffs by China and other countries. Additional tariffs imposed by the United States on a broader range of imports, or further retaliatory trade measures taken by China or other countries in response, could result in an increase in supply chain costs that Embecta may not be able to offset or that otherwise adversely impact its results of operations. …”see in full comparison
“In September 2025, the U.S. Commerce Department Bureau of Industry and Security (the “Department”) initiated a national security investigation into imports of personal protective equipment, medical consumables, and medical equipment, including devices such as pen needles and insulin syringes, under Section 232 of the Trade Expansion Act of 1962 (the “Trade Act”). The Trade Act allows the President of the U.S. to negotiate tariffs to promote international trade, including the authority to impose tariffs if the Department determines imports threaten the U.S. national security. …”see in full comparison
Changes in United States policy regarding international trade, including import and export regulation and international trade agreements, could also negatively impact Embecta’s business.see in full comparisonThe United States has imposed tariffs and export controls on certain goods and products imported from China and certain other countries, which has resulted in retaliatory tariffs by China and other countries. Additional tariffs imposed by the United States on a broader range of imports, or further retaliatory trade measures taken by China or other countries in response, could result in an increase in supply chain costs that Embecta may not be able to offset or that otherwise adversely impact its results of operations.In addition, political tensions between the United States and China and certain other countries have escalated in recent years between and among these countries. Rising political tensions could reduce trade, investment and other economic activities between the two major economies. Any of these factors could have a material adverse effect on Embecta’s business, prospects, financial condition and results of operations.
Full comparison: every changed paragraph (76)
•Embecta obtains components and raw materials for its products from third parties, including BD. These third parties may fail to perform under their agreements with Embecta, or there may be a reductionreduction, interruption, or interruptiontermination in the manufacturing and supply of these components and raw materials. Any such failure to perform or a reductionreduction, interruption, or interruptiontermination in supply could have a material adverse effect on Embecta’s business and operations.
•Trade actions, such as tariffs, retaliatory tariffs, and private or governmental "buy local" initiatives could adversely and unexpectedly impact our business.
•Breaches of Embecta’s informationInformation systemsSystems (as defined in Item 1C of this Annual Report on Form 10-K) or cyberattacks could adversely affect our business.
•The closing of the Separation was deferred in certain jurisdictions, and may not occur at all in such jurisdictions, due to local regulatory requirements, which may adversely affect Embecta’s business, financial condition and results of operations.
•The material weakness in our internal control over financial reporting that has been identified and our ability to remediate such material weakness.
The medical technology industry is subject to rapid technological change and frequent introduction of new products. The development of new or improved products, processes or technologies by other companies (such as new technologies to administer insulin) that provide better features, pricing, clinical outcomes or economic value may make Embecta’s existing or new products less competitive. In some instances, competitors, including pharmaceutical companies, also offer, or are attempting to develop, alternative therapies, including oral and once-weekly anti-diabetic drugs,drugs GLP-1s(e.g., SGLT-2s, once-weekly insulin, GLP-1s, and GLP-1 combination products,products), for disease states (including diabetes) that may be administered and delivered less frequently compared to conventional and historical multiple daily injections or without a medical device, such as pen needles.needles, entirely. Lower cost producers have also created pricing pressure, particularly in emerging markets. There can be no assurance that Embecta’s products will be commercially successful, and it is possible that its business will be adversely affected from time to time as a result of products developed by its competitors.
The diabetes treatment industry is subject to technological change and product innovation. A number of companies and medical researchers are developing and commercializing new ways to deliver insulin to patients, including insulin administration technologies that do not require the use of a needle, that reduce the frequency of insulin administration, or that treat diabetes without the use of insulin or by delaying the use of insulin, such as oral and once-weekly anti-diabetic drugs,drugs GLP-1s(e.g., SGLT-2s, once-weekly insulins, GLP-1s, and GLP-1 combination products.products). If they are successful in developing and commercializing these technologies or treatment therapies, the demand for Embecta’s products could decline.decline or be delayed. Furthermore, the National Institutes of Health and other supporters of diabetes research are continually seeking ways to prevent diabetes. Any technological breakthroughs in diabetes prevention or treatment could decrease demand for Embecta’s products and have a material adverse effect on its business or results of operations.
Embecta obtains components, services and raw materials for its products from third parties, including BD. These third parties may fail to perform under their agreements with Embecta, or there may be a reductionreduction, interruption, or interruptiontermination in the manufacturing and supply of these components and raw materials. Any such failure to perform or a reductionreduction, interruption, or interruptiontermination in supply could have a material adverse effect on Embecta’s business and operations.
In addition, in connection with the Separation, Embecta and BD entered into a lease agreement for a manufacturing facility location in Holdrege, Nebraska that Embecta leases from BD and several contract manufacturing agreements where BD provides certain manufacturing services to Embecta. If BD is unable to perform under these arrangements, terminates certain services or modifies its operations and Embecta cannot find substantially similar alternatives to perform these services or is forced to change its operations as a result, Embecta may incur additional costs, delays or other deficiencies in its operations, which could materially adversely affect Embecta’s business, financial condition or results of operations.
Embecta also obtains other component parts and raw materials from other third parties. In many cases, Embecta does not have long-term supply agreements with suppliers of these component parts and raw materials, and its arrangements with these suppliers are on a purchase-order basis. Certain raw materials that we obtain from suppliers are subject to fluctuations in price and availability attributable to a number of factors, including general economic conditions,conditions and environments, such as new and changing tariff policies instituted by the U.S. government and foreign governments, commodity price fluctuations, the demand by other companies for the same raw materials and the availability of complementary and substitute materials. In some cases, Embecta’s agreements with suppliers can be terminated by either party by convenience upon short notice.
Certain raw materials and components used in the manufacture of pen needles and syringes, including cannulas, certain oil-based resins and rubber stoppers, are not always available from multiple sources. New laws or regulations influenced or adopted in response to local and international tariff policies, or climate changechange, among others, could also increase import duties, energy andcosts, transportation costs, as well asand the overall costs of certain raw materials and components. In addition, for quality assurance, cost-effectiveness and other reasons, Embecta purchases certain raw materials and components from a single supplier.supplier, who in turn sometimes rely on their own single or sole sourced sub-suppliers for certain materials or components. The price and supply of these materials and components may be affected or disrupted for reasons beyond Embecta’s control.control, including, but not limited to, such suppliers or sub-suppliers changes or cessation of business operations, whether voluntary or involuntary, and limitations in the availability of their materials, labor, or other resources. While Embecta works with suppliers to ensure continuity of supply, no assurance can be given that these efforts will be successful. In the event that any of its existing supply arrangements are terminated or there is a reduction or interruption of supply under these existing arrangements, Embecta expects that it will be able to enter into new arrangements with current or alternative suppliers, but these new arrangements may be on terms that are less favorable, including with respect to price and volume, and it may be costly or cause delays in Embecta’s manufacturing process to transition to a new supplier,supplier or new raw material or component, particularly in cases in which Embecta must comply with regulatory requirements relating to qualification of new suppliers or replacement raw materials or components from current suppliers. The termination, reduction or interruption in supply of these raw materials and components could adversely impact Embecta’s ability to manufacture and sell certain of its products.
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Third-party suppliers may encounter problems during manufacturing for a variety of reasons, including failure to follow specific protocols and procedures, failure to comply with applicable regulations, equipment malfunction, component part supply constraints, and environmental factors, any of which could delay or impede their ability to supply the components and raw materials for Embecta’s products. In addition, these third-party suppliers may be influenced or compelled to stop or pause shipments to Embecta due to new or changing tariff policies as a result of supply chain disruption, uncertainty over costs, and potential retaliatory measures from their local governments. Any such failure to perform or a reductionreduction, interruption, or interruptiontermination in supply could have a material adverse effect on Embecta’s business and operations.
Embecta may experience difficulties and delays inherent in manufacturing its products, such as failure of Embecta or its suppliers to comply with applicable regulations and quality assurance guidelines, which failures may lead to: manufacturing suspensions, shutdowns or delays; delays related to the construction of new facilities or the expansion of existing facilities; and other manufacturing or distribution problems, including changes in manufacturing production sites and limits to manufacturing capacity resulting from regulatory requirements, changes in types of products produced and physical limitations that could affect supply. In addition, Embecta could experience difficulties or delays in manufacturing its products caused by the impact of natural disasters, global conflicts, health pandemics, and shipping delays at ports of entry or exit. Manufacturing difficulties can also result in product shortages, leading to lost sales and reputational harm. In addition, many of Embecta’s products require sterilization prior to sale. In some instances, only a few facilities are qualified under applicable regulations to conduct this sterilization. To the extent Embecta or third parties (including BD) are unable to sterilize Embecta’s products, whether due to lack of capacity, increased demand, regulatory requirements or changeschanges, or otherwise, Embecta 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 Embecta’s business.
A substantial portion of Embecta’s revenue is derived from sales to a few customers. For example, for the fiscal year ended September 30, 2024,2025, gross sales to Cencora, McKesson Corporation, and Cardinal Health and Cencora,Health, Embecta’s three largest distributors, together represented approximately 41%42% of Embecta’s worldwide gross sales. The costs charged by these and other distributors to distribute Embecta’s products is also subject to negotiation, and such distributors may propose increases in such charges from time to time. In addition, for the fiscal year ended September 30, 2024,2025, direct gross sales to the five largest retail pharmacies for Embecta’s products together represented approximately 14% of Embecta’s worldwide gross sales. If any of Embecta’s largest customers reduce the amount of product that they purchase from Embecta, negotiate a reduced price for such products or increase the charges to distribute such products, each could have a material adverse effect on Embecta’s business, financial condition and results of operations.
In addition, consolidation and integration among healthcare institutions and providers significantly affects the competitive landscape for medical devices. Health plans, pharmacy benefit managers,managers ("PBMs"), wholesalers, and other supply chain stakeholders have been consolidating into fewer, larger entities, thus enhancing their purchasing strength and importance. Specifically, private third-party insurers and governments typically maintain formularies that specify coverage (the conditions under which drugs and medical devices are included on a plan’s formulary) and reimbursement (including both the associated out-of-pocket cost to the consumer and payment to the distributor) to control costs by negotiating discounted prices, inflation guarantees and other terms in exchange for formulary inclusion.
Embecta is consistently managing the burden of continued pressures associated with payers’ discount requirements to maintain positive formulary positions. If Embecta fails to maintain these formulary positions or reduces prices on its products to maintain these formulary positions, it could adversely affect Embecta’s results of operations. In addition to the evolving payer market that continues to put price pressure on Embecta’s products, new competitors have emerged. Competitors that are new to the pen needle and insulin syringe categories, along with some that have emerged to begin engaging with payers, have accelerated the focus on these product categories, providing payers more choices for formulary partners within these medical device categories. In addition to pressures imposed by public and private payers, the Centers for Medicare & Medicaid Services (“CMS”) of the U.S. Department of Health and Human Services (“HHS”) has begun implementing measures outlined in the Inflation Reduction Act of 2022 to negotiate prices on certain high cost prescription drugs for Medicare beneficiaries, as well as proposing competitive bidding on other medical devices, including those used for the treatment of diabetes. Embecta’s products are covered by Medicare Part D covered medical devices and if there is any expansion of price negotiations or competitive bidding by CMS, or other agencies, for the category of products within which Embecta competes and Embecta is unable to successfully negotiate favorable pricing for its products, it could adversely impact Embecta’s financial condition and results of operations.
The U.S. Congress and many U.S. States have and may continue to scrutinize key participants in the healthcare industry, including PBMs. A number of bills have been introduced, proposed, and passed that would further regulate PBMs and impose additional requirements. The FTC has issued statements about PBMs and conducted a study of PBMs that resulted in two published reports, which could motivate further actions with respect to PBMs regulation. The FTC also filed an administrative complaint against the three largest PBMs and their affiliated group purchasing organizations alleging that the PBMs engaged in anti-competitive and unfair practices that increased costs for insulin medication. It is unclear what the results of this matter and the above noted PBMs scrutiny will be, and what impact this will have on the PBMs industry and our business, financial condition and results of operations.
A significantAn element of Embecta’s strategy is to increase revenue growth by focusing on innovation and new product development. Even if Embecta submits an application to the FDA or foreign regulatory authorities for approval and/or clearance, there is no assurance that such approval or clearance will be obtained or that Embecta will be able to market and sell such products successfully. New product development requires significant investment in research and development. The results of Embecta’s product development efforts may be affected by a number of factors, including Embecta’s ability to anticipate the needs of people with diabetes, successfully complete clinical and other trials, obtain regulatory clearance and approvals for its products, manufacture such products in a cost-effective manner, obtain appropriate intellectual property protection for such products, gain and maintain market acceptance of such products, secure distribution channels, and obtain access, coverage and reimbursement for such products. Even if cleared by the FDA or foreign regulatory agencies,authorities, future generations of our systems,products, expanded indications for use of future systems, our software platformsproducts, or any other systemproducts under development, may not be cleared for the indications that are necessary or desirable for successful commercialization. There can be no assurance that Embecta will be able to successfully develop or commercialize any products now in development or that Embecta may seek to fully develop or commercialize such products in the future.
A substantial amount of Embecta’s sales come from its operations outside the United States, and Embecta intends to continue to pursue growth opportunities outside of the United States, especially in emerging markets. Embecta’s international operations subject it to certain risks relating to, among other things, fluctuations in foreign currency exchange, local economic and political conditions, competition from local companies, increases in trade protectionism, United States relations with the governments of the foreign countries in which Embecta operates, foreign regulatory requirements or changes in such requirements, changes in local healthcare payment systems and healthcare delivery systems, local or non-U.S. originated product preferences and/or requirements, longer payment terms for account receivables than we experience in the United States, difficulty in establishing, staffing and managing foreign operations, changes to international trade agreementspolicies, agreements, tariffs, regulations, and treaties, changes in tax laws, weakening or loss of the protection of intellectual property rights in some countries and import or export licensing requirements. The success of Embecta’s international operations also depends, in part, on its ability to make necessary infrastructure enhancements to, among other things, its production facilities and sales and distribution networks. These and other factors may adversely impact its ability to pursue its growth strategy in these regions.
•trade protection measures and barriers, such as tariffs, and import and export licensing, customs, control and compliance requirements;
•difficulties associated with foreign legal systems,systems or other foreign regulations or commitments, including increased costs or penalties associated with enforcing or fulfilling certain governmental and/or non-governmental contractual obligations in foreign jurisdictions;
Changes in United States policy regarding international trade, including import and export regulation and international trade agreements, could also negatively impact Embecta’s business. The United States has imposed tariffs and export controls on certain goods and products imported from China and certain other countries, which has resulted in retaliatory tariffs by China and other countries. Additional tariffs imposed by the United States on a broader range of imports, or further retaliatory trade measures taken by China or other countries in response, could result in an increase in supply chain costs that Embecta may not be able to offset or that otherwise adversely impact its results of operations. In addition, political tensions between the United States and China and certain other countries have escalated in recent years between and among these countries. Rising political tensions could reduce trade, investment and other economic activities between the two major economies. Any of these factors could have a material adverse effect on Embecta’s business, prospects, financial condition and results of operations.
In 2015, the Italian parliament enacted legislation that, among other things, imposed a “"payback”" measure on medical device companies that supply goods and services to the Italian National Healthcare System. Under the measure, companies are required to make payments to the Italian government if medical device expenditures in a given year exceed regional expenditure ceilings established for that year. The payment amounts are calculated based on the amount by which the regional ceilings for the given year were exceeded. In response to decrees issued by the Italian Ministry of Health, the various Italian regions issued invoices to medical device companies. Following the issuance of the invoices, numerous other medical device companies filed appeals with the Italian administrative courts challenging the enforceability of the payback measure, primarily on the basis that the law was unconstitutional. The Italian administrative courts referred the question regarding the constitutionality of the law to the Italian Constitutional Court, which in July 2024, issued a ruling upholding the law as constitutional. Following the ruling of the Italian Constitutional Court, the appeal before the Italian administrative court willwas proceedrejected within respectMay to2025 and Italy passed the remainingEconomic legalDecree arguments(Law assertedDecree byNo. 95/2025) in June 2025 offering a 75% discount on payback amounts for the appellantsyears with2015 regardthrough to2018. Although Embecta has paid and settled its 2015 through 2018 obligations, the enforceabilitydeterminations offor the2019 paybackand law.after Sinceare thestill law was enacted,pending. Embecta has recognized an estimate for the amount of variable consideration but has not made any payments under the payback law.law Asfor litigation2019 beforeand Italianafter. Courts is still pending,Given final resolution is unknown at this time, and it is possible that the amount of the Embecta’s liability could differ from the amount currently accrued.
The military conflict between Russia and Ukraine has resulted in the implementation of sanctions by the United States and other governments against Russia and has caused significant volatility and disruptions to the global markets. ItAlthough the impact of the conflict on our supply chain has not been significant, it is not possible to predict the short- and long-term implications of this conflict, which could include but are not limited to further sanctions, uncertainty about economic and political stability, increases in inflation rate and energy prices, supply chain challenges, adverse effects on currency exchange rates and financial markets and disruption to its supplier, channels to market or customers. In addition, the United States government reported that United States sanctions against Russia in response to the conflict could lead to an increased threat of cyberattacks against United States companies. These increased threats could pose risks to the security of Embecta’s Information Technologyinformation systems, networks and product offerings, as well as the confidentiality, availability and integrity of Embecta’s data. In addition, the hostilities in Israel and the Middle East, including attacks on shipping vessels in the Red Sea, could develop to have a more widespread economic and geopolitical affect in the Middle East and Europe, and/or economic sanctions between or among countries, as well as general geopolitical issues in the Middle East. These disruptions have led to supply chain delays and price increases and may impact future oil production capacity, oil prices, and disruptions in supply chain and shipping routes in the Middle East. These impacts may further cause increases in resin costs, as well as energy costs. If these conflicts develop beyond these areas or further intensify, they could have an adverse impact on Embecta’s business operations in the EU, the Middle East or other affected areas. Embecta is continuing to monitor the situations in Russia, Ukraine, Israel and globally as well as assess their potential impact on Embecta’s business, including impacts to suppliers and customers. Although operations in Russia, Ukraine and Israel do not currently constitute a material portion of Embecta’s business nor has Embecta assessed that the hostilities have had a material effect on its financial position or results of operations, a significant escalation or further expansion of the conflicts’ current scope or related disruptions to the global markets could have a material adverse effect on Embecta’s results of operations.
The U.S. Department of the Treasury’s Office of Foreign Assets Control, and the Bureau of Industry and Security at the U.S. Department of Commerce, administer certain laws and regulations that restrict U.S. persons and, in some instances, non-U.S. persons, in conducting activities, and transacting business with or making investments in certain countries, governments, entities and individuals subject to U.S. economic sanctions. Due to Embecta’s international operations, it is subject to such laws and regulations, which are complex, restrict its business dealings with certain countries and individuals, and are constantly changing.changing, Furtherincluding laws and regulations regarding sanctioned countries, entities and persons, customs, and import-export, which restrict, and in some cases can prevent, U.S. companies from directly or indirectly selling goods or services to people or entities in certain countries. These laws also require the appropriate amount of scrutiny in any engagement with these persons and entities in and from certain foreign countries. Given we also sell and provide products to agents, representatives, and distributors, who may export such items to customers and end-users, if we, or the third parties through which we do business, are not in compliance with applicable import, export control, or economic sanctions laws and regulations, we may be subject to civil or criminal enforcement action, and varying degrees of liability. Such actions may disrupt or delay sales of our products or services or result in further restrictions on our distribution and sales of products or services and further restrictions may be enacted, amended, enforced or interpreted in a manner that materially impacts Embecta’s operations.
Trade actions, such as tariffs, retaliatory tariffs, and private or governmental "buy local" initiatives could adversely and unexpectedly impact our business.
Given that a significant amount of our raw materials, components and products are sold and distributed globally, the actions by the U.S. government or foreign governments could impact both the availability and cost of our products. Most notably, new tariffs are, and could be, levied on raw materials and products shipped to the U.S. and raw materials and products that originate from the U.S. that are distributed globally. For example, in April 2025, the current administration in the U.S. increased tariff rates, subject to evolving exemptions, on numerous raw materials and products from a range of nations and has announced on several occasions its intentions to potentially increase or decrease current tariffs, impose additional tariffs, and/or expand or reduce tariffs on raw materials and goods imported from various countries. In addition, earlier this year, the U.S. government imposed a universal baseline tariff on imports globally and raised the Section 232 tariff on imported steel for many countries.
In September 2025, the U.S. Commerce Department Bureau of Industry and Security (the “Department”) initiated a national security investigation into imports of personal protective equipment, medical consumables, and medical equipment, including devices such as pen needles and insulin syringes, under Section 232 of the Trade Expansion Act of 1962 (the “Trade Act”). The Trade Act allows the President of the U.S. to negotiate tariffs to promote international trade, including the authority to impose tariffs if the Department determines imports threaten the U.S. national security. If it is determined these imports pose a national security risk, the ultimate impact remains uncertain and will depend on several factors, but could result in additional potential tariffs imposed in addition to the country-based tariffs, reductions on the benefit Embecta receives from currently available exemptions, additional trade protection measures, embargoes, import or export licensing requirements, trade sanctions or similar restrictions, all of which could significantly increase our costs, strain our resources, and/or create additional complexity in the management of our business and interpretation and compliance with such changes. This may also cause foreign countries to implement retaliatory tariffs or other retaliatory measures. Any such changes could have a material impact on our business, financial condition and results of operations.
The current tariff environment evolves continuously and is uncertain. The United States has imposed tariffs and export controls on certain goods and products imported from China and certain other countries, which has resulted in retaliatory tariffs by China and other countries. Additional tariffs imposed by the United States on a broader range of imports, or further retaliatory trade measures taken by China or other countries in response, could result in an increase in supply chain costs that Embecta may not be able to offset or that otherwise adversely impact its results of operations. In addition, the U.S. government has imposed, modified, and paused tariffs multiple times since the beginning of 2025, with changes to tariffs and other trade restrictions announced at any time, sometimes with little or no advanced notice. As noted above, we export certain raw materials and products to other countries that have and may take future actions in response to these tariffs.
The use of tariffs as a policy tool has created significant uncertainty about the future trading relationship among the U.S., China, the European Union, Canada, Mexico and other exporting countries, including with respect to trade policies, treaties, government regulations and tariffs, and has led to concerns regarding the potential for extended trade barriers. The escalation of trade tensions could impact us in a variety of ways, including increases in manufacturing costs, disruptions or delays to our global supply chain, limitations on our ability to sell our products, and reductions in sales volumes and gross margins for our products, any of which could materially affect our business, financial condition and results of operations. We also face uncertainty in the interpretation of new tariffs and their applicability, including with respect to customs valuation, product classification and country-of-origin determinations. Although we and our suppliers seek to comply with applicable customs laws and regulations, the application of rules regarding new tariffs can be subject to varying interpretations or future re-interpretations. For example, the ongoing litigation regarding the IEEPA tariffs case that was recently heard by the U.S. Supreme Court has created additional uncertainty as to the scale and short and long-term effect these tariffs will have on Embecta and the medical device industry overall. It is possible that U.S. or other relevant courts or authorities could, upon review or audit, disagree with the authority, valuation, rules of origin or classification methods applied to certain products. Any such disagreement could result in the retroactive assessment of additional duties with interest, the imposition of penalties, or other enforcement actions without the ability to mitigate such penalties, thereby adversely affecting our operations or financial results.
Furthermore, certain of our competitors may be better positioned than us to withstand or react to border taxes, tariffs or other restrictions on global trade and, as a result, we may lose market share to such competitors. Finally, certain governmental and private purchasers have threatened to or may restrict the purchase of products from certain countries (including the U.S.) in favor of “buying local,” 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 our business and operations. We cannot control the duration or depth of any of the above such actions which may increase our product costs, reduce our margins, potentially decrease the competitiveness of our products, or result in loss of certain contracts. These actions could have a negative effect on our business, results of operations, or financial condition.
The long-term effects of global climate change present risks to Embecta’s business and operations. Extreme or severe weather, natural disastersdisasters, flooding, heat events, or other conditions caused by climate change could adversely impact its supply chainchain, logistics, and operations, and the availability and cost of raw materials and components, energy supply, transportation or other inputs required for the operation of its business. Such conditions could also result in physical damage to products, plants and distribution centers, or our suppliers' facilities, as well as the infrastructure and facilities of hospitals, medical care facilities and other customers. Additionally, increased environmental regulation, including to address climate change, may result in increases in the costs to operate its business or restrict certain aspects of its activities. These events could adversely affect Embecta’s operations and our financial performance.
The Russia and Ukraine conflict, the Israel-Hamasconflict war,in the Middle East, the possibility of military activity in countries near or adjacent to Israel, including attacks on shipping vessels in the Red Sea, and the growing geopolitical tensions between China and Taiwan, coupled with possible related supply chain shortages may affect the energy power and oil sector’s networks and ability to supply their customers, including Embecta. These disruptions have led to supply chain delays and price increases and may lead to manufacturing shutdowns, raw material and component shortages, additional supply chain and logistics constraints, project delays, loss of productivity, divergent product standards and regulations, trade policies, labor shortages, commodity shortages, and additional price increases, among others. Embecta relies on uninterrupted energy to power its manufacturing facilities and any disruption could adversely affect its operations. In addition, increases in energy and oil prices could increase the production, raw materials and other costs of Embecta’s operations and products.
Increases in interest rates may adversely affect the financial condition of Embecta’s distributors and suppliers, thereby adversely affecting their ability to buy Embecta’s products and supply the components or raw materials needed by Embecta, in each case adversely affecting Embecta’s financial condition or results of operations. IfAlthough interest rates have recently been declining, if the United States Federal Reserve decides to raise the benchmark interest rate, then Embecta could experience higher interest expense on its variable rate debt in fiscal year 2025.2026. To the extent Embecta borrows under its revolving credit facility, it will also be subject to risks related to changes in interest rates.
As a global company, Embecta is subject to taxation in numerous countries, states and other jurisdictions. Embecta’s effective tax rate is derived from a combination of applicable tax rates in the various countries, states and other jurisdictions in which it operates. In preparing its financial statements, Embecta estimates the amount of tax that will become payable in each of these jurisdictions and significant judgementjudgment is required in determining our worldwide provision for income taxes. Embecta’s effective tax rate may, however, differ from the estimated amount due to numerous factors, including a change in overall profitability, geographical mix of earnings before income taxes, tax discrete items that are not recurring in nature, and changes in tax laws, including potential proposed tax legislation. The Organization for Economic Cooperation and Development ("OECD") has developed major reform of the international tax system with respect to a global minimum 15% tax rate. In December 2022, European Union member states agreed to adopt the OECD’s minimum tax rules, which are expected to begin going into effect in tax years beginning on January 1, 2024 or later. Certain countries have enacted the law changes and other countries are considering changes to their tax laws; the impact of the changes will go into effect for the Company beginning in fiscal year 2025. The Company is evaluating the impact of these proposed and enacted changes. If any potential legislative proposals are ultimately enacted, they could materially impact Embecta’s tax provision, cash tax liability and effective tax rate. Any of these factors could cause Embecta to experience an effective tax rate significantly different from previous periods or its current expectations, which could have an adverse effect on its business, financial condition, results of operations and cash flows.
For example, the Organization for Economic Cooperation and Development ("OECD") has developed major reform of the international tax system with respect to a global minimum 15% tax rate. European Union member states agreed to adopt the OECD’s minimum tax rules, which went into effect for tax years beginning on January 1, 2024 or later. Certain countries have enacted the law changes and other countries are considering changes to their tax laws. The impact of the changes went into effect for the Company beginning in fiscal year 2025. The global minimum tax rules did not have a material impact to our provision for income taxes for the fiscal year ended September 30, 2025.
Also, on July 4, 2025, the U.S. One Big Beautiful Bill Act ("OBBBA") was enacted which includes permanent extensions of certain expiring provisions of the Tax Cuts and Jobs Act and makes significant modifications to the U.S. international tax framework. The legislation has multiple effective dates, with certain provisions effective beginning in fiscal year ended September 30, 2025 and others becoming effective through the fiscal year ended September 30, 2027. OBBBA did not have a material impact to our provision for income taxes for the fiscal year ended September 30, 2025.
If any existing legislation is amended or subject to revised interpretation, or if legislative proposals are ultimately enacted, in their current or amended form, they could materially impact Embecta’s tax provision, cash tax liability and effective tax rate. Any of these factors could cause Embecta to experience an effective tax rate significantly different from previous periods or its current expectations, which could have an adverse effect on its business, financial condition, results of operations and cash flows.
Embecta faces various security threats on a regular basis, including ongoing cyber security threats to and attacks on our information technology and data infrastructure. Some of Embecta’s products,products and productsservices in development may,may include information systems that collect data, including sensitive medical information, regarding patients and patient therapy on behalf of Embecta’s customers and some connect to Embecta’s systems for maintenance and management purposes. Embecta uses its and certain third party, including BD's,party information technology systems to manage or support a variety of business processes and activities, includingincluding, but not limited to, sales, shipping, distribution, billing, customer service, procurement, supply chain, manufacturing, and accounts payable. In addition, Embecta uses enterprise information technology systems to record, process, and summarize transactions and other financial information and results of operations for internal reporting purposes and to comply with financial reporting, legal, and tax regulatory requirements. Embecta deploys defenses against such threats and attacks and works to secure the integrity of its dataInformation systemsSystems using techniques, hardware, and software typical of companies of its size and scope. Despite Embecta’s security measures, however, its information technology and data infrastructure may be vulnerable to attacks by increasingly sophisticated intruders or others who try to cause harm to or interfere with itsthe normal use of its systems. They are also susceptible to breach due to employee error, malfeasance, or other disruptions. Embecta’s suppliers, distributors, contractors, service providers, partners, and other third parties with whom it does business could also could be subject to cyber threats and attacks that are similar in frequency and sophistication. In many cases, Embecta has to rely on the controls and safeguards put in place by these suppliers, distributors, contractors, service providers, including BD,partners, and other third parties to defend against, respond to, and report these attacks. Many of Embecta’s informationInformation systemsSystems are cloud-hosted and managed by these third-party vendors, some of which may have access to confidential business, employee, healthcare professional, and/or customer information. Embecta’s informationInformation technology systemsSystems may also be susceptible to damage, disruptions, or shutdowns due to computer viruses, attacks by computer hackers, failures during the process of upgrading or replacing software, databases or components thereof, power outages, hardware failures, telecommunication failures, user errors, or catastrophic events. Any failure by Embecta to maintain or protect its informationInformation technology systemsSystems and data integrity, including from cyberattacks, intrusions, disruptions, or shutdowns, could result in the unauthorized access to customercustomer, datavendor, andor patient data, including personally identifiable information or personal health information, theft of intellectual property or other misappropriation of assets or the loss of key data and information, or otherwise compromise Embecta’s confidential or proprietary information and disrupt its operations. The potential impact of future cyber incidents can vary widely in severity and scale. This could also impact Embecta’s compliance with privacy and other laws and regulations and could result in actions by regulatory bodies or government agencies, and/or or civil litigation. There can be no assurance that the various procedures and controls Embecta utilizes to mitigate these threats will be sufficient to prevent disruptions to its systems, in part because (i) cyberattack techniques change frequently and, at times, new techniques are not recognized until launched, and (ii) cyberattacks can originate from a wide variety of sources. For example, as multilateralMultilateral sanctions and tensions continue tocould escalate againstbetween certain countries, such as between Russia byand western nations and their alliesallies, in connection with certain global events like the Russia-UkraineRussia Ukraine war, which could lead to retaliatory actions being undertaken by Russia and supporters of Russia in the form of cyberattacks have increased, including for example against certain U.S. infrastructure networks and hospital operations.operations in the form of cyberattacks by Russia, supporters of Russia, or other parties and nations. Increasing costs associated with information security, such as increased investment in technology, the cost of compliance and costs resulting from consumer fraud could cause our business and results of operations to suffer materially. The methods and techniques used by cyber threat actors to gain entry into our network and access our computer systems, software and data may become more advanced with the use of Artificial Intelligence (“AI”) and may become increasingly difficult or impossible to detect and prevent. As these threats continue to evolve, we may be required to invest significant additional resources to modify and enhance our information security and controls or to investigate and remediate any security vulnerabilities. While our technology infrastructure is designed to safeguard and protect personal and business information, we have limited ability to monitor the implementation of similar safeguards by our vendors. Additionally, following the onset of the COVID-19 pandemic, many employees transitioned to a remote or hybrid work environment, which has increased risks associated with our information technology systems and networks. These increased risks include cyber-attacks, computer viruses, disruptions, or shutdowns that could result in a failure to protect our Information Systems and data integrity. Embecta will continue to evaluate organization risk priorities and dedicate resources to protect against unauthorized access, and work to align to industry-leading cybersecurity frameworks to incorporate cybersecurity into its enterprise systems, manufacturing processes and products. Embecta’s results of operations could be adversely affected if these systems are interrupted or damaged or fail for any extended period.
In addition, medical devices are increasingly connected to the internet, healthcare networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients and patients to manage their conditions. As such, a cyberattack which intrudes, disrupts, or corrupts Embecta’s devices, products, and services, or related devices, products, and services could impact the quality-of-care patients receive or the confidentiality of customer or patient information. Additionally, modifying or using any such devices, products, or services in a way inconsistent with Embecta’s FDA and other national and international regulatory government clearances and approvals may create risks to users and potential exposure to the Company.
Embecta’s operations are global and are affected by complex state, federal and international laws relating to healthcare, environmental protection, antitrust, anti-corruption, marketing, fraud and abuse (including anti-kickback and false claims laws), import and export control, product safety and efficacy, employment, privacy,privacy and cybersecurity, financial transparency, conflict minerals and other areas. Violations of these laws can result in criminal or civil sanctions, including substantial fines and, in some cases, exclusion from participation in healthcare programs such as Medicare and Medicaid. Environmental laws, particularly with respect to the emission of greenhouse gases, such as taxes on fuel and energy, to mitigate the impacts of climate change, are becoming more stringent throughout the world, including tightening emissions standards, which may increase Embecta’s costs of operations or necessitate closures of or changes to its manufacturing plants or processes or those of its suppliers, or result in liability to Embecta. EmbectaFor isexample, alsoEmbecta’s operations and facilities may become subject to variousformal or informal scrutiny, audit, or enforcement actions or proceedings for noncompliance with environmental laws related to substances released into the environment. Such matters are typically resolved with regulatory authorities through commitments to compliance, abatement, or remediation programs, and, in some cases, payment of penalties or fines. The U.S. and international governments have increasingly been regulating perfluorooctane sulfonate, perfluorooctanoic acid, and/or other per- and poly-fluoroalkyl substances. These regulations relatinginclude tightening emission standards and limits as to the safetypresence of certain compounds. As a result of uncertainties associated with environmental regulations and effectivenessrequired remediation activities, costs incurred to maintain our compliance or resolve or remediate any identified issues could have an adverse effect on our business, results of medical devices, including relating to design, developmentoperations and manufacturing,cash product traceability and record keeping procedures, product complaints, complaint reporting, recalls and field safety corrective actions, advertising and promotion and clinical trials and post-market studies with respect to its products. Failure to comply with these laws may result in enforcement actions by the FDA or other similar regulatory agencies and other liability to Embecta. The enactment of additional laws or changes in existing laws may increase compliance costs or otherwise adversely impact Embecta’s operations.flows.
Embecta is also subject to various laws and regulations relating to the safety and effectiveness of medical devices, including relating to design, development and manufacturing, product traceability and record keeping procedures, product complaints, complaint reporting, recalls and field safety corrective actions, advertising and promotion and clinical trials and post-market studies with respect to its products. Failure to comply with these laws may result in enforcement actions by the FDA or other similar national and international regulatory agencies and other liability to Embecta. The enactment of additional laws or changes in existing laws may increase compliance costs or otherwise adversely impact Embecta’s operations.
Embecta is also subject to numerous post-marketing regulatory requirements, which includeinclude, but are not limited to, quality system regulations related to the manufacture of its devices, labeling regulations, and medical device reporting regulations. The last of these regulations requires Embecta to report to the FDA or other similar regulatory agencies if its devicesproducts cause or contribute to a death or serious injury, or malfunction in a way that would likely cause or contribute to a death or serious injury if the malfunction recurred. If Embecta fails to comply with present or future regulatory requirements that are applicable to it, it may be subject to enforcement action by the FDA, which may include any of the following sanctions:
•administrative detention by the FDA or other similar regulatory agencies of medical devices believed to be adulterated or misbranded or otherwise in violation of other regulatory laws;
Other medical device regulations in countries that Embecta does business in vary substantially from country to country. We must obtain the requisite regulatory approvals, clearances, registrations, and certifications to comply with extensive safety and quality regulations in those countries. The time required to obtain these to market our products, including those related to the transition of our branding from BD to embecta labelled products, may be longer or shorter than those required for FDA clearance or approval, and the requirements may differ. For example, medical devices in the European Economic Area need to comply with specific requirements and affix the CE mark to their medical devices, often after the intervention of a Notified Body and the issuing of a CE Certificate of Conformity. In addition, the EU has adopted the EU Medical Device Regulation (the “EU MDR”), which imposes stricter requirements for the marketing and sale of medical devices, including in the area of labeling requirements, clinical evidence requirements, quality systems and post-market surveillance. The EU MDR has been fully operational for previously approved self-certified medical devices (class I) since May 2021, and previously CE marked products must become compliant when their certification expires, with a transition period ending December 2027 for higher classification devices, or December 2028 for lower classification devices (i.e., class II and III). Additionally, the availability of EU notified body services certified to assist Embecta with validation of, and compliance with, the new requirements is limited, which may delay the marketing approval for some of Embecta's products under the EU MDR. Any such delays, or any failure to meet these requirementsrequirements, or the revocation or suspension of our regulatory approvals, clearances, registrations, or certifications could adversely impact our business in the EU andEU, other non-EU regions that tie their product registrations to EU conformity requirements.requirements, or other foreign countries.
The Patient Protection and Affordable Care Act (the “Affordable Care Act”) substantially changed the way healthcare is financed by both government and private insurers. It also encourages improvements in the quality of healthcare products and services and significantly impacts the United States pharmaceutical and medical device industries by, among other things, imposing certain stringent compliance, recordkeeping, and reporting requirements on companies in various sectors of the life sciences industry, and enhanced penalties for non-compliance. The current U.S. administration has implemented a number of regulatory, policy, and personnel changes, including, but not limited to, the elimination, downsizing, and reduced funding of certain government agencies and programs and the cancellation or delay of government contracts and research grants, each of which may be exacerbated by any future government shutdowns. The current administration has also changed the composition of, and guidance from, advisory panels on healthcare practices and government enforcement.
Changes in government funding for the FDA and other government agencies could affect their ability to obtain and retain key resources and personnel, properly administer medical device innovation, or prevent Embecta’s products from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing routine business functions on which the operation of Embecta’s business relies, which could adversely affect its business.
Recent U.S. government shutdowns caused certain regulatory agencies, such as the FDA and the SEC, to furlough critical employees and stop critical activities. In addition, the U.S. government implemented substantial layoffs and workforce reductions in connection with recent federal government shutdown, which resulted in the suspension or delay of various government-funded programs. While the recent government shutdown has ended, there is no assurance that future government shutdowns will be avoided that affect government employees and contractors or government-funded programs. If there are any future government shutdowns, the ability of the FDA to review and approve or clear new products or to provide feedback on our programs, applications, and submissions can be affected by a variety of factors, including government budget and funding levels, reductions in workforce, ability to obtain and retain key personnel, and statutory, regulatory and policy changes. In addition, there may be delays in necessary interactions with regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government or contractor personnel. Government shutdowns, if prolonged, can significantly impact the ability of government agencies upon which we rely, such as the FDA and SEC, to operate and perform their duties as normal, which could have a material adverse effect on our business.
Disruptions at the FDA and other agencies may also slow the time necessary for our operations, facilities, products, submissions, and applications to be reviewed, approved, or cleared by the necessary government agencies, which could adversely affect our business, financial condition and results of operations. For example, the current U.S. administration has discussed several changes to the reach and oversight of the FDA, which could affect its relationship with the medical device industry, transparency in decision making and ultimately the cost and availability of medical devices and our products. Additionally, over the past decade, the U.S. government has shut down several times, and certain regulatory agencies, such as the FDA, have had to furlough critical employees and stop critical activities. The current U.S. administration also recently announced plans to reduce the number of federal employees by establishing voluntary termination programs, by position eliminations or by involuntary terminations. If funding for the FDA is reduced, if the FDA workforce is reduced, or if futuregovernment shutdown occur, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. In addition, there remains substantial uncertainty as to how the current U.S. administration will seek to or continue to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates. This uncertainty could present new challenges and the commercial prospects for our separation activities, operations, and business may be harmed and our ability to generate revenue may be adversely affected.
Furthermore, AI-based solutions, including generative AI, are increasingly being used in the medical device industry, including by Embecta, with the expectation to use such systems and tools that incorporate AI-based technologies in the future for internal and external purposes. The use of AI solutions, such as ChatGPT, Co-Pilot, Grammarly, and Transvoyant by Embecta’s employees or third parties on which we rely could lead to the public disclosure of confidential information (including personal data or proprietary information) in contravention of Embecta’s internal policies, data protection or other applicable laws, or contractual requirements. The misuse of AI solutions could also result in unauthorized access and use of personal data of Embecta’s employees, clinical and other trial and research participants, collaborators, or other third parties. In addition, the legal and regulatory landscape surrounding AI technologies is rapidly evolving and uncertain, including in the areas of intellectual property, cybersecurity, and privacy and data protection. Evolving rules, regulations, and industry standards governing AI may require us to incur significant costs to modify, maintain, or align our business practices, services and solutions to comply with U.S. and non-U.S. rules and regulations, the nature of which cannot be determined at this time and may be inconsistent from jurisdiction to jurisdiction. SeveralAs a result of the growing worldwide availability and release of AI-based technologies, there is a global trend towards more regulation and several jurisdictions where we operate or may intend to operate are considering or have proposed or enacted legislation and policies regulating AI and non-personal data,data. suchThese asinclude, but are not limited to, the European Union’s AI ActAct, the U.S. executive administration’s AI Action Plan and other Executive Orders on AI, and the U.S.’svarious ExecutiveAI Orderlaws onenacted AI.in certain States within the U.S. These regulations are aimed at the ethical use, privacy, and security of AI and the data it processes and may impose significant requirements and costs on how we deploy and use AIAI, handle data and handlecomply data.with these current and future regulations, and any changes or amendments thereto. While we attempt to identify and mitigate ethical and legal issues presented by itsthe use,use of AI, we may be unsuccessful in identifying or resolving issues before they arise. Failure to appropriately respond to this evolving landscape may also result in legal liability, fines, penalties, regulatory action, loss of data or trade secrets or other intellectual property, brand and reputational harm, or lead to outcomes with unintended biases or other consequences. On the other hand, if Embecta is unable to use AI, it could make our business less efficient and result in competitive disadvantages. Any of these events could have a material adverse effect on our business, financial condition and results of operations.
Another global pandemic like COVID-19, including due to new variants of the virus for which current vaccines may not be effective, and public health measures could result in the imposition of new governmental lockdowns, quarantine requirements or other restrictions to slow the spread of the virus. This could significantly impact our supply chain if the manufacturing plants that produce our products or product components, the distribution centers where we manage our inventory, or the operations of our logistics and other service providers, including third parties that sterilize our products, are disrupted, temporarily closed, or experience worker shortages for a sustained period of time. These future developments, which are highly uncertain and cannot be predicted with confidence could adversely affect Embecta's financial condition.
For example, Embecta’s manufacturing sites in China, Ireland and the United States, where Embecta manufactures a significant amount of products, largely avoided any significant disruption due to the COVID-19 pandemic. However, notwithstanding that each of these communities has experienced a relative recovery in COVID-19 transmission and a lessening of restrictions related to COVID-19, a future outbreak of a public health threat, including COVID-19, at any of Embecta’s manufacturing sites in China, Ireland and/or the United States or in the surrounding communities, could lead to suspensions or delays in the manufacturing of Embecta’s products, which could have a material adverse effect on Embecta’s business and results of operations.
Moreover, any resurgence in COVID-19 infections, including due to new variants of the virus for which current vaccines may not be effective, and public health measures could result in the imposition of new governmental lockdowns, quarantine requirements or other restrictions to slow the spread of the virus. The extent to which fear of exposure to or actual effects of COVID-19, new variants, disease outbreak, epidemic or a similar widespread health concern impacts our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the speed and extent of geographic spread of the disease, the duration of the outbreak, travel restrictions, the efficacy of vaccination and treatment; impact on the U.S. and international healthcare systems, the U.S. economy and worldwide economy, the timing, scope and effectiveness of U.S. and international governmental response, and the impact on the health, well-being and productivity of our employee. These could result in closures or other restrictions that significantly disrupt Embecta’s operations or those of distributors or suppliers in Embecta’s supply chain, which could adversely affect Embecta's financial condition.
Certain historical information about Embecta in this Annual Report on Form 10-K refers to the diabetes care business as operated by and integrated with BD. Certain historical financial information of Embecta’s fiscal year 2022 included in this Annual Report on Form 10-K is derived from the accounting records of BD. Accordingly, certain historical financial information included in this Annual Report on Form 10-K does not necessarily reflect the financial condition, results of operations or cash flows that we would have achieved in previous fiscal years as a separate, publicly traded company during such periods or those that Embecta will achieve in the future primarily as a result of the factors described below:
•Generally, prior to the Separation, Embecta’s working capital requirements and capital for its general corporate purposes, including capital expenditures and acquisitions, were historically satisfied as part of the corporate-wide cash management policies of BD. On a going forward basis, Embecta’s results of operations and cash flows may be more volatile, and it may need to obtain additional financing from banks, through public offerings or private placements of debt or equity securities, strategic relationships or other arrangements, which may or may not be available and may be more costly.
•Prior to the Separation, Embecta’s business was operated by BD as part of its broader corporate organization, rather than as an independent company. BD or one of its affiliates performed various corporate functions for us, such as legal, treasury, accounting, auditing, human resources, investor relations, and finance. The historical financial results for the periods prior to the Separation reflect allocations of corporate expenses from BD for such functions, which are likely to be less than the expenses we would have incurred had we operated as a separate publicly traded company.
•Embecta’s business shared economies of scope and scale in costs, employees, vendor relationships and customer relationships with BD. While we have sought to minimize the impact on Embecta when separating these arrangements, there is no guarantee these arrangements will continue to capture these benefits in the future. While Embecta has entered into transition agreements that govern certain commercial and other relationships between it and BD, those arrangements may not capture the benefits to Embecta's business that resulted from being integrated with the other affiliates of BD.
•Prior to the Separation, Embecta’s business utilized the advantage of BD’s overall size and scope to procure more advantageous arrangements. As a standalone company, Embecta may be unable to obtain similar arrangements to the same extent as BD did, or on terms as favorable as those BD obtained, prior to completion of the Separation.
•The cost of capital for Embecta’s business may be higher than when Embecta was integrated with BD and leveraged BD’s cost of capital.
Management's Discussion & Analysis (MD&A)
New heading “Receivables Sale Agreement”
Removed heading “Separation from BD”
Removed heading “Periods Prior to Separation”
Removed heading “Periods Post Separation”
Removed heading “Impairment expense”
Removed heading “Factoring Agreements”
Removed heading “Update to the unaudited Consolidated Statements of Cash Flows Reported in Earnings Release”
Largest changes
“Cost of products sold increased by $17.0 million, or 4.6%, to $387.9 million for the year ended September 30, 2024 as compared to $370.9 million for the year ended September 30, 2023. Cost of products sold as a percentage of revenues were 34.5% for the year ended September 30, 2024 as compared to 33.1% for the year ended September 30, 2023. …”see in full comparison
“Cost of products sold increased by $15.7 million, or 4.0%, to $403.6 million for the year ended September 30, 2025 as compared to $387.9 million for the year ended September 30, 2024. Cost of products sold as a percentage of revenues were 37.4% for the year ended September 30, 2025 as compared to 34.5% for the year ended September 30, 2024. …”see in full comparison
“We estimate that we will incur approximately $25 million - $30 million in pre-tax cash-based charges primarily associated with employee severance payments and benefits related to the workforce reduction. We expect that the majority of the restructuring charges related to the workforce reduction will be incurred in the first quarter of fiscal year 2025 and that the implementation of the workforce reduction, including cash payments, will be substantially complete by the end of the second quarter of fiscal year 2025.”see in full comparison
“We estimate that we will incur approximately $10 million - $15 million of additional pre-tax non-cash charges related to asset impairments and asset write-offs. These preliminary estimates may be revised following the completion of the ongoing analysis of the expected additional pre-tax non-cash charges associated with the implementation of the Restructuring Plan.”see in full comparison
“During the year ended September 30, 2023, the Company recorded impairment charges of $2.5 million related to the abandonment of certain manufacturing equipment in China that is no longer in use that was inherited as part of the Separation from BD. These assets were previously included as a component of Machinery, equipment and fixtures within Property, Plant and Equipment in our Consolidated Balance Sheets in Item 8 of this Annual Report on Form 10-K. The impairment charges are recognized within Impairment expense in the Consolidated Statements of Income.”see in full comparison
Full comparison: every changed paragraph (77)
Separation from BD
Pursuant to the Separation and Distribution Agreement, the Separation from BD was completed on April 1, 2022. On March 22, 2022, the record date for the distribution, 57,012,925 issued and outstanding shares of Embecta common stock were distributed pro-rata to BD stockholders as of the close of business, determined by applying a ratio of one share of Embecta common stock for every five shares of BD common stock. "Regular-way" trading of Embecta common stock began on April 1, 2022, under the ticker symbol "EMBC".
Periods Prior to Separation
Prior to the Separation, the Company was referred to as the Diabetes Care Business. For periods prior to April 1, 2022, the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K include certain assets, liabilities, revenues, and expenses that were historically held at the BD corporate level, but are specifically identifiable or otherwise allocable to the Diabetes Care Business.
Periods Post Separation
For the periods subsequent to April 1, 2022, as a standalone publicly traded company, Embecta presents its financial statements on a consolidated basis. The Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K have been prepared in accordance with accounting principles generally accepted in the United States of America.
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. This has forced providers to provide clinical evidence to differentiate their products.
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.
Changes in Clinical Practice. Introduction of new drugs and increased penetration of oral and once-weekly anti-diabetic drugs (e.g., SGLT-2s),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.
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. Tariffs did not have a material impact on our fiscal year 2025 results. 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.
In December 2023, we submitted our first 510(k) premarket filing to the FDA for our proprietary disposable insulin delivery system. In September, 2024, we announced that we received 510(k) clearance from the FDA. On November 22, 2024, the Company's Board of Directors approved a plan to discontinue internal and external investment in the research and development of our patch pump program. As a resultresult, ofthe thisCompany decision, we will undergo anincurred organizational restructuring plan (the "Patch Pump Restructuring Plan"). costs of $34.5 million during the year ended September 30, 2025. Restructuring actions associated with the Patch Pump Restructuring Plan to discontinue the patch pump program are substantially complete as of September 30, 2025. In addition, we intend to discontinuediscontinued our commercial operation plans for the insulin delivery system, including the previous intended limited launch. The Company plans to refocus its investment on its core business while looking to optimize free cash flow and strengthen its balance sheet by paying down debt.
During the second quarter of fiscal year 2025, the Company initiated a restructuring plan (the "2025 Restructuring Plan") to streamline the organization and optimize resources. As a result, the Company incurred organizational restructuring plan costs of $3.5 million during the year ended September 30, 2025. The 2025 Restructuring Plan is substantially complete as of September 30, 2025.
We estimate that we will incur approximately $25 million - $30 million in pre-tax cash-based charges primarily associated with employee severance payments and benefits related to the workforce reduction. We expect that the majority of the restructuring charges related to the workforce reduction will be incurred in the first quarter of fiscal year 2025 and that the implementation of the workforce reduction, including cash payments, will be substantially complete by the end of the second quarter of fiscal year 2025.
We estimate that we will incur approximately $10 million - $15 million of additional pre-tax non-cash charges related to asset impairments and asset write-offs. These preliminary estimates may be revised following the completion of the ongoing analysis of the expected additional pre-tax non-cash charges associated with the implementation of the Restructuring Plan.
The estimates of the pre-tax cash charges and additional charges that we expect to incur in connection with the Restructuring Plan, and the timing thereof, are subject to a number of assumptions and actual amounts may differ materially from estimates. In addition, we may incur other pre-tax cash charges or additional charges not currently contemplated due to unanticipated events that may occur, including in connection with the implementation of the Restructuring Plan.
On March 28, 2024, we entered into (i) a second amendment (the “TSA Amendment”) to the TSA, dated as of March 31, 2022 and previously amended as of July 1, 2022 by and between Embecta and BD, and (ii) a second amendment (the “LSA Amendment”) to the LSA, dated January 1, 2022 and previously amended as of November 20, 2023, by and between Embecta and BD. Pursuant to the TSA and the LSA, originally entered into in connection with the Separation, Embecta and BD and their respective affiliates provide each other, on an interim, transitional basis, the Business Continuity Processes. Under the TSA Amendment and the LSA Amendment, BD granted Embecta, among other things, a limited extension until November 1, 2024 of certain services in a limited set of markets to support the Business Continuity Processes.
We continue to monitor the conflict in Ukraine and the associated sanctions and other restrictions. We also are monitoring the Israel-Hamasconflicts warin the Middle East and Houthi attacks on commercial shipping vessels and other naval vessels. As of DecemberNovember 11,25, 2024,2025, 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. See Item 1A of this Annual Report on Form 10-K for further details.
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 risingchanging 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.
•Revenue increaseddecreased by $2.3$42.7 million to $1,123.1$1,080.4 million from $1,120.8$1,123.1 million;
•Operating income decreased by $54.7 million to $166.8 million from $221.5 million; and
•NetOperating income increased by $7.9$75.3 million to $78.3$242.1 million from $70.4$166.8 million.million; and
•Net income increased by $17.1 million to $95.4 million from $78.3 million.
Our revenues decreased by $42.7 million, or 3.8%, to $1,080.4 million for the year ended September 30, 2025 as compared to revenues of $1,123.1 million for the year ended September 30, 2024. Changes in our revenues are driven by the volume of goods that we sell, the prices we negotiate with customers, and changes in foreign exchange rates. The decrease in reported revenues was primarily driven by $52.9 million of unfavorable changes in volume and $3.5 million associated with the negative impact of foreign currency translation primarily due to the strengthening of the U.S. dollar. This was partially offset by a $6.9 million increase in contract manufacturing revenues related to sales of non-diabetes products to BD, $4.8 million of favorable changes in gross-to-net adjustments attributed to the recognition of higher incremental Italian payback accruals in fiscal year 2024 as compared to fiscal year 2025, and a $2.0 million increase associated with favorable changes in price. See Item 1A of this Annual Report on Form 10-K for further details.
Our revenues increased by $2.3 million, or 0.2%, to $1,123.1 million for the year ended September 30, 2024 as compared to revenues of $1,120.8 million for the year ended September 30, 2023. The increase in revenues was primarily driven by $27.7 million associated with favorable changes in price. This was partially offset by $14.5 million of unfavorable changes in volume, $6.1 million associated with the negative impact of foreign currency translation primarily due to the strengthening of the U.S. dollar, $4.6 million of unfavorable gross-to-net adjustments primarily attributed to the recognition of incremental Italian payback accruals resulting from two July 22, 2024 rulings by the Constitutional Court of Italy, and a $0.2 million decrease in contract manufacturing revenues related to sales of non-diabetes products to BD.
Cost of products sold increased by $15.7 million, or 4.0%, to $403.6 million for the year ended September 30, 2025 as compared to $387.9 million for the year ended September 30, 2024. Cost of products sold as a percentage of revenues were 37.4% for the year ended September 30, 2025 as compared to 34.5% for the year ended September 30, 2024. The increase in cost of products sold was primarily driven by the impact of net changes from profit in inventory adjustments period over period and non-cash asset impairment charges recorded to write down the carrying value of certain property and equipment as a result of the Company's Patch Pump Restructuring Plan. This was partially offset by lower volumes in fiscal year 2025 compared to fiscal year 2024.
Cost of products sold increased by $17.0 million, or 4.6%, to $387.9 million for the year ended September 30, 2024 as compared to $370.9 million for the year ended September 30, 2023. Cost of products sold as a percentage of revenues were 34.5% for the year ended September 30, 2024 as compared to 33.1% for the year ended September 30, 2023. The increase in cost of products sold was primarily driven by the impact of inflation on the costs of certain raw materials (including freight), direct labor, and overhead, the impact of negative year-over-year manufacturing variances primarily attributable to the as planned temporary shutdown of our Suzhou, China facility as it relates to production for the domestic Chinese market, and unfavorable impacts due to foreign exchange rates. We intend to continue to work to improve productivity to help partially offset these increased costs. This was partially offset by the impact of profit in inventory adjustments as a result of inventory that was sold to external customers that was manufactured in anticipation of our ERP system and other Business Continuity Processes that went live during fiscal 2024.
Operating expenses in 2024 and 2023 were as follows:
Our selling and administrative expenses increaseddecreased by $23.8$33.1 million, or 7.0%,9.1%, to $332.0 million for the year ended September 30, 2025 as compared to $365.1 million for the year ended September 30, 2024 as compared to $341.3 million for the year ended September 30, 2023.2024. The increasedecrease year over year was primarily driven by an increase in compensation and benefit costs due to increased headcount on average in the current period in addition to increased outbound freight and warehousing costs. This was partially offset by lower TSA and LSA costs incurred fromwith BD in theaddition currentto lower compensation expense recognized in fiscal year period.2025.
Our research and development expenses decreased by $6.4$41.5 million, or 7.5%,52.7%, to $37.3 million for the year ended September 30, 2025 as compared to $78.8 million for the year ended September 30, 2024 as compared to $85.2 million for the year ended September 30, 2023.2024. The decrease was primarily driven by timinga ofreduction expensesin incurredpayments made in connection with the development of our insulin patch pump platform.program in fiscal year 2025 as compared to fiscal year 2024, given the discontinuation of the patch pump program.
On November 22, 2024, the Company's Board of Directors approved a plan to discontinue internal and external investment in the research and development of the Company's patch pump program. The Company will refocus its research and development strategy on its core business. We expect our research and development expense to decrease sequentially in fiscal year 2025 compared to fiscal year 2024.
Impairment expense
During the year ended September 30, 2024, the Company did not record any impairment charges.
During the year ended September 30, 2023, the Company recorded impairment charges of $2.5 million related to the abandonment of certain manufacturing equipment in China that is no longer in use that was inherited as part of the Separation from BD. These assets were previously included as a component of Machinery, equipment and fixtures within Property, Plant and Equipment in our Consolidated Balance Sheets in Item 8 of this Annual Report on Form 10-K. The impairment charges are recognized within Impairment expense in the Consolidated Statements of Income.
We incurred other operating expenses of $124.5 million and $99.4 million for the years ended September 30, 2024 and 2023, respectively.
The costs incurred primarily relate to accounting, auditing, legal services, marketing, supply chain, employee retention, costs associated with the implementation of our new ERP system and other Business Continuity Processes, and certain other costs to establish certain stand-alone functions to assist with the transition to being a stand-alone entity. These costs also include certain severance costs related to the optimization of certain business functions as we transition to being a stand-alone entity. We expect the amount of those costs to be less in fiscal year 2025 as compared to fiscal year 2024.
For the year ended September 30, 2024, we recognized costs associated with the amortization of cloud computing arrangements. For the year ended September 30, 2023, there was no amortization of implementation costs associated with cloud computing arrangements due to the timing of when these projects were placed into service.
Other operating expenses 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 Interim 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;
•Restructuring related costs associated with the optimization of certain business functions as we transition to being a stand-alone entity;
•Severance and contract termination costs associated with the discontinued patch pump program; and
•Costs recognized associated with the amortization of cloud computing arrangements.
Interest expense, net increaseddecreased to $107.3 million for the year ended September 30, 2025, from $112.3 million for the year ended September 30, 2024, from $107.0 million for the year ended September 30, 20232024 primarily asdriven aby resultlower ofdebt higherlevels and lower short-term interest rates onin ourthe variablecurrent rateperiod debtas which is attributablecompared to increasesthe inprior SOFR that impacted our Term Loan. This was partially offset by an increase in interest income from amounts held in interest bearing accounts and money market funds.period. We are unable to predict future Federal Reserve interest rate decisions and the impact to interest expense on our variable rate debt. See "Liquidity and Capital Resources" below and Note 1312 to the Consolidated Financial Statements included elsewhere in this Annual Report on Form 10-K for a further description of our long-term debt.
Other income (expense), net was $(10.3)$1.5 million and $(8.810.3) million for the years ended September 30, 20242025 and 2023,2024, respectively. The changeincome generated in Other income (expense), netfiscal year over2025 yearwas isprimarily driven by higher losses dueattributed to unfavorablefavorable impacts from foreign exchangeexchange. inThe thecosts incurred for fiscal year ended September 30, 2024 offsetwere byprimarily lowerattributed to amounts paiddue to BD for income taxes payable incurred in deferred jurisdictions where BD is considered the primary obligor inand the currentunfavorable periodimpacts comparedfrom withforeign the year ended September 30, 2023.exchange.
Income tax provision (benefit) increased to $40.9 million for the year ended September 30, 2025 from $(34.1) million for the year ended September 30, 2024. This increase was primarily due to the absence of 2024 tax benefits from the recognition of deferred tax assets related to tax reform in Switzerland, the absence of 2024 tax benefits from the reduction of withholding tax accruals on unremitted foreign earnings resulting from the expiration of certain stock ownership holding period requirements, fewer nontaxable items of income and the correlative tax impacts of these changes on higher overall earnings in 2025. This was partially offset by tax benefits from tax return true ups for tax filings made during 2025.
See Note 14 to the Consolidated Financial Statements included elsewhere in this Annual Report on Form 10-K for a further description of our provision for income taxes.
The Company's income tax provision (benefit) decreased to $(34.1) million for the year ended September 30, 2024 from $35.3 million for the year ended September 30, 2023. This decrease was primarily due to a reduction in withholding taxes on unremitted earnings of foreign subsidiaries related to the expiration of a two-year stock holding period requirement in Switzerland, the recognition of deferred tax assets from Switzerland tax reform, changes in the geographical mix of earnings and overall lower pre-tax earnings; partially offset by an increase in uncertain tax positions and non-deductible expenses.
InDuring the year ended September 2024,30, 2025 , the Company madepaid aan discretionaryaggregate prepaymentprincipal amount of $25.0approximately $184.6 million on the Term Loan.Loan, of which $175.1 million was discretionary. Debt extinguishment charges as a result of thisthese prepaymentdiscretionary prepayments were not material to the Company's Consolidated Statements of Income.
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.
Receivables Sale Agreement
During the third quarter of fiscal year 2025, the Company entered into 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, $63.2 million of trade receivables were sold during fiscal year 2025, resulting in derecognition of the receivables from the Company's Consolidated Balance Sheets. Discounts recognized on the sale of trade receivables were not material to the Company's Consolidated Statements of Income. The cash received on the sale of trade receivables during fiscal year 2025 is presented in changes in trade receivables, net within operating activities in the Consolidated Statement of Cash Flows.
Factoring Agreements
In conjunction with the Separation, we entered into Factoring Agreements (the "Factoring Agreements") with BD. Embecta owed BD a service fee calculated as 0.1% of annual revenues related to countries subject to the Factoring Agreements, in exchange for the services provided by BD pursuant to the Factoring Agreements.
As of March 31, 2024, all Factoring Agreements between Embecta and BD had expired and terminated as a result of our implementation and onboarding of certain Business Continuity Processes in North America, and certain jurisdictions in Europe and Asia.
In May 20242025 and June 2024,2025, Moody’s Investor Services and Standard & Poor’s Ratings Services published updates toand 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+.
Update to the unaudited Consolidated Statements of Cash Flows Reported in Earnings Release
On November 26, 2024, we furnished a Current Report on Form 8-K that included as an exhibit a press release announcing our financial results for the fourth fiscal quarter and the fiscal year ended September 30, 2024 (the “Earnings Release”). Subsequent to furnishing the Earnings Release, the Company identified certain further revisions within the Consolidated Statements of Cash Flows that results in changes to the operating assets and liabilities related to Prepaid expenses and other and Income and other net taxes payable for fiscal 2024 that were reported in the Condensed Consolidated Statements of Cash Flows including in the Earnings Release. The updated amounts for these line items are included in the audited Consolidated Statements of Cash Flows included in the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K. Fiscal 2024 Net Cash Provided by Operating Activities of $35.7 million as presented in the Earnings Release remains unchanged from the amount presented on this Annual Report on Form 10-K.
The change in accounts payable and accrued expenses is primarily due to timing attributable to payments to vendors during the fiscal year ended September 30, 2024.vendors.
As a result of the implementation of certain Business Continuity Processes, including our ERP system that went live in November 2023 for our North America business operations and in March 2024 for our EMEA and Greater Asia business operations as well as the expiration and termination of the Factoring Agreements between Embecta and BD, we are now responsible for the collection of any outstanding trade receivables in those respective regions. The increase in trade receivables is a direct result of this impact, and we expect to convert these outstanding trade receivables into cash in line with contractual customer payment terms.
The change in inventories is driven by actions taken to increase raw material purchases and finished goods in the current fiscal year in anticipation of our ERP system and other Business Continuity Processes that went live during fiscal year 2024.
What changed in the latest 10-Q
Risk Factors
There have been no material changes to Embecta’s risk factors from those described in “Risk Factors” included within the 2025 Form 10-K and Embecta's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 filed with the Securities and Exchange Commission on May 5, 2026.
Removed heading “The pendency of our acquisition of OM may have an adverse effect on our business, financial condition, operating results and cash flows.”
Removed heading “We cannot guarantee that the Repurchase Program will be fully consummated or that it will enhance long-term stockholder value, and stock repurchases could increase the volatility of the price of our common stock.”
Removed heading “The conflict between the United States, Israel, and Iran and related geopolitical instability may adversely affect our business.”
Largest changes
“In February 2026, the United States and Israel launched a coordinated military effort against Iran. …”see in full comparison
“The conflict between the United States, Israel, and Iran and related geopolitical instability may adversely affect our business.”see in full comparison
“We cannot guarantee that the Repurchase Program will be fully consummated or that it will enhance long-term stockholder value, and stock repurchases could increase the volatility of the price of our common stock.”see in full comparison
“The pendency of our acquisition of OM may have an adverse effect on our business, financial condition, operating results and cash flows.”see in full comparison
“Our business is subject to risks and uncertainties, a number of which are described under the caption “Risk Factors” in the 2025 Form 10-K. The risks described in the 2025 Form 10-K and below may not be the only risks we face but are risks we believe may be material at this time. Other risks of which we are not yet aware, or that we currently believe are not material, may also materially and adversely impact our business operations or financial results. …”see in full comparison
“There have been no material changes to Embecta’s risk factors from those described in “Risk Factors” included within the 2025 Form 10-K and Embecta's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 filed with the Securities and Exchange Commission on May 5, 2026.”see in full comparison
Full comparison: every changed paragraph (8)
There have been no material changes to Embecta’s risk factors from those described in “Risk Factors” included within the 2025 Form 10-K and Embecta's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 filed with the Securities and Exchange Commission on May 5, 2026.
Our business is subject to risks and uncertainties, a number of which are described under the caption “Risk Factors” in the 2025 Form 10-K. The risks described in the 2025 Form 10-K and below may not be the only risks we face but are risks we believe may be material at this time. Other risks of which we are not yet aware, or that we currently believe are not material, may also materially and adversely impact our business operations or financial results. If any of the events or circumstances described in the risk factors contained in the 2025 Form 10-K or included below occurs, our business, financial condition, liquidity, results of operations or ability to repurchase common stock or pay dividends could be adversely impacted and the value of an investment in our securities could decline. Investors and prospective investors should consider the risks described in the 2025 Form 10-K and below and the information contained under the caption “Cautionary Statements Regarding Forward-Looking Statements” and elsewhere in this Form 10-Q before deciding whether to invest in our securities.
The pendency of our acquisition of OM may have an adverse effect on our business, financial condition, operating results and cash flows.
On March 19, 2026, we entered into the Purchase Agreement to acquire OM. The transaction (the “Acquisition”) is expected to close in the third fiscal quarter of 2026. All closing conditions and regulatory approvals have been satisfied. We have devoted, and will continue to devote, significant management and other internal resources towards the completion of the Acquisition and planning for integration. There can be no assurance that our business, financial condition, operating results, and cash flows will not be adversely affected, if the Acquisition is delayed or is not consummated. Further, even if the Acquisition is consummated, we may not realize the benefits to us that we currently anticipate from the Acquisition, including increasing our revenues and expanding our current product offerings. If we do not successfully integrate the operations of OM as currently anticipated, it could adversely affect our financial condition and results from operations.
We cannot guarantee that the Repurchase Program will be fully consummated or that it will enhance long-term stockholder value, and stock repurchases could increase the volatility of the price of our common stock.
Pursuant to the Repurchase Program authorized by our Board of Directors in May 2026, we are authorized to repurchase shares of our common stock, for up to $100.0 million, through various methods, including, but not limited to, open market, privately negotiated, or accelerated share repurchase transactions. The Repurchase Program may be suspended or discontinued at any time. We are not obligated to repurchase a specified number or dollar amount of shares, and the timing, manner, price, and actual amount of share repurchases will depend on a variety of factors, including stock price, market conditions, other capital allocation needs and opportunities, and corporate and regulatory considerations. The timing of repurchases pursuant to our Repurchase Program could affect our stock price and increase its volatility. We cannot guarantee that we will repurchase shares, and there can be no assurance that any share repurchases will enhance stockholder value because the stock price of our common stock may decline below the levels at which we effected repurchases.
The conflict between the United States, Israel, and Iran and related geopolitical instability may adversely affect our business.
In February 2026, the United States and Israel launched a coordinated military effort against Iran. Although we do not have material operations in the Middle East, the ongoing conflict and any further escalation, including additional military actions, retaliatory measures, sanctions, disruptions to trade or transportation routes, cyberattacks, or other governmental or market responses, has and could continue to lead to significant disruption of global energy supplies and increases in global energy prices, heighten inflationary pressures on our input costs and supply chain, adversely affect global supply chains, energy markets, commodity prices, currency exchange rates, financial markets and overall macroeconomic conditions, and adversely impact customer spending patterns in markets in which we operate. While the conflicts between the United States, Israel, and Iran may have an effect on our business, financial condition and results of operations, we are unable to predict the extent or nature of these impacts at this time.
Management's Discussion & Analysis (MD&A)
Largest changes
“•Risks associated with the putative securities class action filed in June 2026 or any other litigation.”see in full comparison
Cost of products soldsee in full comparisondecreasedincreased by$6.2$13.8 million, or3.1%,4.6%, to$193.5$311.9 million for thesixnine months endedMarchJune31,30, 2026 as compared to$199.7$298.1 million for thesixnine months endedMarchJune31,30, 2025. Cost of products sold as a percentage of revenues was40.1%41.3% for thesixnine months endedMarchJune31,30, 2026 as compared to38.3%36.5% in thesixnine months endedMarchJune31,30, 2025. Thedecreaseincrease in cost of products sold for thesixnine month comparative period was primarily driven byloweradditionalvolumes,cost of products sold from Owen Mumford during the third quarter, as well as the impact of net changes from profit in inventory adjustments period overperiod, and 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 currentperiod.This was partially offset by an increase due to a shift in product mix in the current period as compared to the prior period.
“As discussed in Part II, Item 5. Other Information within this Form 10-Q, on August 6, 2026, we entered into the First Amendment to our Credit Agreement which, among other things, reduced the aggregate revolving credit commitments from $500 million to $310 million and extended the maturity of $210 million of the revolving credit commitments to December 30, 2028. …”see in full comparison
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,see in full comparisontheEmbecta'sPatchstockPumprepurchaseRestructuring Plan,plan, the2025impactRestructuringofPlan,the OM acquisition, 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:
Onsee in full comparisonMarchMay19,15, 2026,theweCompanyacquiredenteredOwenintoMumford, adefinitive agreement to acquire OM (the "Purchase Agreement") for approximately £150 million. OM is a privately held,UK-based innovator and manufacturer of medical devices and drug-deliverytechnologies. Under the terms of the Purchase Agreement, the Company will acquire OMtechnologies for an upfront cash payment of £100126.0millionmillion,atwhichclosingincluded(a payment for estimated acquired cash and equivalents. The final purchase price is subject tocustomaryaadjustments,workingincludingcapitalforadjustmentclosingtonetbecash),finalizedandin a future period. We willpayalso make a payment of up toan additional£5050.0 million upon the achievement of certain commercial milestones related to sales of the Aidaptus® next-generation auto-injectorplatformplatform.throughThe U.S. dollar equivalents, as of theperiodacquisitionendingdate,Junefor30,the2029.upfrontAllcashclosing conditionspayment andregulatorypotentialapprovalsfuturehavemilestonebeenpaymentssatisfiedwere $169.9 million andthe$67.4transactionmillion,is expected to close within the third fiscal quarter of 2026.respectively.
Onsee in full comparisonMarchMay19,15, 2026, weentered into a definitive agreement to acquireacquired OwenMumford Holdings Limited (the "Purchase Agreement") for approximately £150 million. Owen Mumford Holdings Limited (“OM”) isMumford, aprivately held,UK-based innovator and manufacturer of medical devices and drug-deliverytechnologies. Under the terms of the Purchase Agreement, we will acquire OMtechnologies for an upfront cash payment of £100126.0millionmillion,atwhichclosingincluded(a payment for estimated acquired cash and equivalents. The final purchase price is subject tocustomaryaadjustments,workingincludingcapitalforadjustmentclosingtonetbecash),finalizedandin a future period. We willpayalso make a payment of up toan additional£5050.0 million upon the achievement of certain commercial milestones related to sales of the Aidaptus® next-generation auto-injectorplatformplatform.throughThe U.S. dollar equivalents, as of theperiodacquisitionendingdate,June 30, 2029. The transaction is expected to close withinfor thethirdupfrontfiscalcashquarterpaymentofand2026.potential future milestone payments were $169.9 million and $67.4 million, respectively.
Full comparison: every changed paragraph (56)
In May 2026, we completed the acquisition of Owen Mumford which accelerated our strategic transformation into a broad-based medical supplies company which provides drug delivery platforms to pharmaceutical companies and serves chronic care patients in the obesity, diabetes, autoimmune diseases and anaphylaxis markets. The strategic opportunity for us is the following:
1.Accelerate growth of our B2B business in the fast-growing drug-delivery market with the Aidaptus auto-injector platform;
2.Globalize Owen Mumford’s existing medical-device portfolio using embecta’s commercial infrastructure in more than 100 countries; and 3.Capture operational and commercial synergies through integration, cross-selling, channel expansion, and manufacturing optimization.
We have a broad portfolio of marketed products,medical devices, including a variety of pen needles, syringes and safety injection devices. With the acquisition of Owen Mumford, we now have a diversified portfolio that also includes auto-injector technology (notably the Aidaptus platform), safety lancets, and other chronic-care and pharmaceutical-services products. 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 continue to monitor global conflicts, including activity in the Middle East and Houthi attacks on commercial shipping vessels and other naval vessels, and the associated sanctions and other restrictions. As of MayAugust 5,7, 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.
On MarchMay 19,15, 2026, we entered into a definitive agreement to acquireacquired Owen Mumford Holdings Limited (the "Purchase Agreement") for approximately £150 million. Owen Mumford Holdings Limited (“OM”) isMumford, a privately held, UK-based innovator and manufacturer of medical devices and drug-delivery technologies. Under the terms of the Purchase Agreement, we will acquire OMtechnologies for an upfront cash payment of £100126.0 millionmillion, atwhich closingincluded (a payment for estimated acquired cash and equivalents. The final purchase price is subject to customarya adjustments,working includingcapital foradjustment closingto netbe cash),finalized andin a future period. We will payalso make a payment of up to an additional £5050.0 million upon the achievement of certain commercial milestones related to sales of the Aidaptus® next-generation auto-injector platformplatform. throughThe U.S. dollar equivalents, as of the periodacquisition endingdate, June 30, 2029. The transaction is expected to close withinfor the thirdupfront fiscalcash quarterpayment ofand 2026.potential future milestone payments were $169.9 million and $67.4 million, respectively.
In May 2026, the Companywe announced that theour Board of Directors approved a three-year $100.0 million stock repurchase authorization (the “Repurchase Program”) of common stock in accordance with applicable securities laws. The Repurchase Program does not obligate the Companyus to acquire any particular amount of common stock and may be suspended or terminated at any time at the Company’sour discretion.
In May 2026, the Board of Directors approved a reduction in the quarterly cash dividend from $0.15 to $0.01 per share of common stock. The dividend iswas payablepaid on June 15, 2026 to stockholders of record as of May 28, 2026.
In May 2026, we initiated a review of our cost structure and organizational footprint which entails aligning company wide commercial activities, exploring opportunities to expand the global reach of the Owen Mumford product portfolio, and taking advantage of scale to negotiate reduced costs.
In May 2026, we initiated a review of our cost structure and organizational footprint.
Our unaudited Condensed Consolidated Statements of (Loss) Income are as follows:
Three Months Ended MarchJune 31,30, 2026 Summary (on a comparative basis)
Key financial results for the three months ended MarchJune 31,30, 2026 were as follows:
•Net (loss) income decreased by $27.6$24.4 million to $(4.1)$21.1 million from $23.5$45.5 million.
SixNine Months Ended MarchJune 31,30, 2026 Summary (on a comparative basis)
Key financial results for the sixnine months ended MarchJune 31,30, 2026 were as follows:
•Operating income increaseddecreased by $26.7$18.6 million to $118.3$167.0 million from $91.6$185.6 million; and
•Net income increaseddecreased by $16.5$7.9 million to $40.0$61.1 million from $23.5$69.0 million.
Our revenues decreased by $37.2$23.8 million, or 14.4%,8.1%, to $221.8$271.7 million for the three months ended MarchJune 31,30, 2026 as compared to revenues of $259.0$295.5 million for the three months ended MarchJune 31,30, 2025. Changes in revenues are driven by the volume of goods that thewe Company sells,sell, the prices it negotiates with customers, and changes in foreign exchange rates. The decrease in revenues was primarily driven by $39.3 million of unfavorable changes in volume, $3.6$20.1 million of unfavorable changes in price, $19.9 million of unfavorable changes in volume and a $2.0$0.1 million decrease in contract manufacturing revenues.revenue. This was partially offset by $7.7the $13.8 million of contribution of Owen Mumford revenues and $2.5 million associated with the positive impact of foreign currency translation primarily due to the weakening of the U.S. dollar.
Our revenues decreased by $37.9$61.7 million, or 7.3%,7.6%, to $483.0$754.7 million for the sixnine months ended MarchJune 31,30, 2026 as compared to revenues of $520.9$816.4 million for the sixnine months ended MarchJune 31,30, 2025. The decrease in revenues was primarily driven by $40.2$60.0 million of unfavorable changes in volume, $7.3$27.4 million of unfavorable changes in price, and a $2.7$2.9 million decrease in contract manufacturing revenues.revenue. This was partially offset by $12.3$14.8 million associated with the positive impact of foreign currency translation primarily due to the weakening of the U.S. dollar.dollar and by the $13.8 million contribution of Owen Mumford revenues.
Cost of products sold decreasedincreased by $0.9$20.0 million, or 0.9%,20.3%, to $94.0$118.4 million for the three months ended MarchJune 31,30, 2026 as compared to $94.9$98.4 million for the three months ended MarchJune 31,30, 2025. Cost of products sold as a percentage of revenues was 42.4%43.6% for the three months ended MarchJune 31,30, 2026 as compared to 36.6%33.3% for the three months ended MarchJune 31,30, 2025. The decreaseincrease in cost of products sold for the three month comparative period was primarily driven by loweradditional volumes,cost of products sold from Owen Mumford during the third quarter, as well as the impact of net changes from profit in inventory adjustments period over period. This was partially offset by an increase due to a shift in product mix in the current period as compared to the prior period.
Cost of products sold decreasedincreased by $6.2$13.8 million, or 3.1%,4.6%, to $193.5$311.9 million for the sixnine months ended MarchJune 31,30, 2026 as compared to $199.7$298.1 million for the sixnine months ended MarchJune 31,30, 2025. Cost of products sold as a percentage of revenues was 40.1%41.3% for the sixnine months ended MarchJune 31,30, 2026 as compared to 38.3%36.5% in the sixnine months ended MarchJune 31,30, 2025. The decreaseincrease in cost of products sold for the sixnine month comparative period was primarily driven by loweradditional volumes,cost of products sold from Owen Mumford during the third quarter, as well as the impact of net changes from profit in inventory adjustments period over period, and 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. This was partially offset by an increase due to a shift in product mix in the current period as compared to the prior period.
Selling and administrative expenses decreased by $3.4$5.8 million, or 4.3%,6.9%, to $76.2$78.6 million for the three months ended MarchJune 31,30, 2026 as compared to $79.6$84.4 million for the three months ended MarchJune 31,30, 2025. Selling and administrative expenses decreased by $6.9$12.7 million, or 4.3%,5.2%, to $153.8$232.4 million for the sixnine months ended MarchJune 31,30, 2026 as compared to $160.7$245.1 million for the sixnine months ended MarchJune 31,30, 2025. The decrease for both the three and sixnine month comparative periods was primarily driven by lower compensation expense in the applicable current periods, partially offset by additional selling and administrative expenses from Owen Mumford in the current periods.
Research and development expenses decreasedincreased by $2.6$1.2 million, or 32.5%,27.3%, to $5.4$5.6 million for the three months ended MarchJune 31,30, 2026 as compared to $8.0$4.4 million for the three months ended MarchJune 31,30, 2025. Research and development expenses decreased by $18.3$17.1 million, or 64.7%,52.3%, to $10.0$15.6 million for the sixnine months ended MarchJune 31,30, 2026 as compared to $28.3$32.7 million for the sixnine months ended MarchJune 31,30, 2025. The increase for the three month comparative period was primarily driven by additional research and development expenses from Owen Mumford during the third quarter. The decrease for both the three and sixnine month comparative periodsperiod was primarily driven by expenses incurred in connection with the development and subsequent discontinuance of our insulin patch pump program in the prior year.year, partially offset by additional research and development expenses from Owen Mumford in the current period.
•Acquisition-related costs associated with the pending acquisition of Owen Mumford.
Interest expense, net decreased by $4.1$2.7 million to $22.6$23.9 million for the three months ended MarchJune 31,30, 2026 as compared to $26.7$26.6 million for the three months ended MarchJune 31,30, 2025. Interest expense, net decreased by $7.9$10.6 million to $46.7$70.6 million for the sixnine months ended MarchJune 31,30, 2026 as compared to $54.6$81.2 million for the sixnine months ended MarchJune 31,30, 2025. The decrease for both the three and sixnine month comparative periods was primarily driven by lower debt levels and lower short-term interest rates in the current period as compared to the prior periods. 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.
Other income (expense), net was $(2.9)$2.8 million and $(0.4)$4.8 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. Other income (expense), net was $(3.20.4) million and $(1.9)$2.9 million for the sixnine months ended MarchJune 31,30, 2026 and 2025, respectively. The decrease for both the three and sixnine month comparative periods was primarily attributed to unfavorable impacts from foreign exchange.
The effective tax rates were 143.2%23.6% and 34.4%37.0% for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The increasedecrease in the Company's effective tax rate compared to the prior period is primarily due to the tax impacts from changes in level and mix of earnings and higher non-deductible costs.
The effective tax rates were 41.5%36.4% and 33.0%35.7% for the sixnine months ended MarchJune 31,30, 2026 and 2025, respectively. The increase in the Company's effective tax rate compared to the prior period is primarily due to the change in mix of earnings and higher non-deductible costs.
The following is a summary of Embecta's total debt outstanding as of MarchJune 31,30, 2026:
The schedule of principal payments required on long-term debt for the next five years and thereafter is as follows:
Certain measures relating to our total debt outstanding as of MarchJune 31,30, 2026 were as follows:
The creditCredit agreementAgreement 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 creditCredit agreementAgreement and indentures governing the 5.00% Notes and the 6.75% Notes. In addition, the creditCredit agreementAgreement 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 MarchJune 31,30, 2026, we were in compliance with all of such covenants. The creditCredit agreementAgreement and the senior secured notes are secured by substantially all assets of Embecta and each subsidiary guarantor, subject to certain exceptions.
As discussed in Part II, Item 5. Other Information within this Form 10-Q, on August 6, 2026, we entered into the First Amendment to our Credit Agreement which, among other things, reduced the aggregate revolving credit commitments from $500 million to $310 million and extended the maturity of $210 million of the revolving credit commitments to December 30, 2028. The more stringent covenants contained in the amended Credit Agreement may make it more difficult for us to successfully execute our business strategy, invest in our growth strategy, and compete against companies that are not subject to such restrictions.
During the sixnine months ended MarchJune 31,30, 2026, the Companywe paid an aggregate principal amount of approximately $75.0$77.4 million on the Term Loan, of which $70.3 million was 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 nine months ended June 30, 2026, we drew down $180.0 million on its Revolving Credit facility and repaid an aggregate principal amount of approximately $50.1 million.
During the sixnine months ended MarchJune 31,30, 2026, the Companywe made interest payments of $44.1$56.3 million on debt outstanding.
For additional information related to the Company's debt related activities, refer to Note 1313, Long-Term Debt within the Notes to Condensed Consolidated Financial Statements within this Form 10-Q.
In May 2026, the Companywe announced that theour Board of Directors approved a three-year $100.0 million stock repurchase authorization of common stock in accordance with applicable securities laws. The Repurchase Program does not obligate the Companyus to acquire any particular amount of common stock and may be suspended or terminated at any time at our discretion. Pursuant to the Company’sRepurchase discretion.Program, we repurchased 2.7 million shares of our common stock for $8.7 million during the three and nine months ended June 30, 2026. We constructively retired the shares of common stock we had repurchased by recording amounts paid in excess of the $0.01 par value of each share as a reduction in additional paid-in capital.
In May 2026, the Board of Directors approved a reduction in the quarterly cash dividend from $0.15 to $0.01 per share of common stock. The dividend iswas payablepaid on June 15, 2026 to stockholders of record as of May 28, 2026.
Maturities of our finance lease and operating lease liabilities as of MarchJune 31,30, 2026 by fiscal year are as follows:
For additional information related to our leases, refer to Note 1920, Leases within the Notes to Condensed Consolidated Financial Statements of this Form 10-Q.
In connection with the Company's receivables sale agreement, $120.3$167.2 million of trade receivables were sold during the sixnine months ended MarchJune 31,30, 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 sixnine months ended MarchJune 31,30, 2025 is presented in changes in trade receivables, net within operating activities in the Condensed Consolidated Statement of Cash Flows. AsFor ofadditional March 31, 2026, the Company had collected $5.4 million, on behalf of the financial institution, which is reflected as Restricted cash and the related obligation to remit the cash within Accrued expenses. The net cash flowsinformation related to thesethe collectionstrade arereceivables reportedsale asagreement, financingrefer activitiesto inNote 17, Receivables Sale Agreement within the Notes to Condensed Consolidated StatementFinancial Statements of Cashthis Flows.Form 10-Q.
PendingOwen Mumford Acquisition
On MarchMay 19,15, 2026, thewe Companyacquired enteredOwen intoMumford, a definitive agreement to acquire OM (the "Purchase Agreement") for approximately £150 million. OM is a privately held, UK-based innovator and manufacturer of medical devices and drug-delivery technologies. Under the terms of the Purchase Agreement, the Company will acquire OMtechnologies for an upfront cash payment of £100126.0 millionmillion, atwhich closingincluded (a payment for estimated acquired cash and equivalents. The final purchase price is subject to customarya adjustments,working includingcapital foradjustment closingto netbe cash),finalized andin a future period. We will payalso make a payment of up to an additional £5050.0 million upon the achievement of certain commercial milestones related to sales of the Aidaptus® next-generation auto-injector platformplatform. throughThe U.S. dollar equivalents, as of the periodacquisition endingdate, Junefor 30,the 2029.upfront Allcash closing conditionspayment and regulatorypotential approvalsfuture havemilestone beenpayments satisfiedwere $169.9 million and the$67.4 transactionmillion, is expected to close within the third fiscal quarter of 2026.respectively.
In March 2026 and JanuaryMay 2026, Moody’s Investor Services and Standard & Poor’s Ratings Services published updates and reaffirmedto our preexisting credit ratings. Our current Moody's Investors Services credit rating is B1B3 and our Standard & Poor's Rating Services credit rating is B+.B.
Cash and equivalents and restricted cash were $193.4$218.2 million as of MarchJune 31,30, 2026 as compared to $228.6 million as of September 30, 2025.
Net cash providedused byfor investing activities for the sixnine months ended MarchJune 31,30, 2026 was compriseddriven by cash paid, net of cash acquired, of $128.4 million to consummate the acquisition of Owen Mumford and capital expenditures of $2.2 million to support our business and operations. This was offset by proceeds from the sale of certain intellectual property rights and long-lived assets of $10.1 million offset by capital expenditures of $1.1 million to support our business and operations.million.
Net cash usedprovided forby financing activities was primarily attributable to:
Our contractual obligations as of MarchJune 31,30, 2026, 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 MarchJune 31,30, 2026, there have been no material changes to our contractual obligations outside the ordinary course of business other than the Purchase Agreement entered into to acquire OM for an upfront cash payment of £100 million at closing (subject to customary adjustments, including for closing net cash), and up to an additional £50 million upon the achievement of certain commercial milestones related to sales of the Aidaptus® next-generation auto-injector platform through the period ending June 30, 2029.business.
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 MarchJune 31,30, 2026.
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, theEmbecta's Patchstock Pumprepurchase Restructuring Plan,plan, the 2025impact Restructuringof Plan,the OM acquisition, 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:
•Risks associated with indebtedness and our use of indebtedness available to us.us, including risks due to restrictions contained in our amended Credit Agreement.
•Embecta's ability to integrate the acquired Owen Mumford business successfully into our business and achieve the expected benefits of the acquisition.
•Risks associated with the putative securities class action filed in June 2026 or any other litigation.
•The risk that we may not complete strategic collaborative partnerships and acquisition opportunities, including the acquisition of OM, in the expected time frames and in a way that enable us to accelerate our growth or strategic collaborative opportunities that give us access to innovative technologies, complementary product lines, and new markets.
EMBC insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 4 Form 4 filings (4 insiders, 1 trade date, 115,000 shares, about $557.9K) and open-market sales in 1 filing (1 insider, 1 trade date, 6,293 shares, about $37.0K). Net open-market shares: 108,707 (purchases minus sales); net value about $520.8K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-04 | Morris Milton Mayo |
Open-market sale | 6,293 | $5.88 | $37.0K |
| 2026-08-12 | Kurdikar Devdatt |
Open-market purchase | 30,000 | $4.70 | $141.0K |
| 2026-08-12 | Elguicze Jacob |
Open-market purchase | 20,000 | $4.67 | $93.4K |
| 2026-08-12 | Mann Jeffrey Z |
Open-market purchase | 20,000 | $4.99 | $99.8K |
| 2026-08-12 | Hombach Robert J. |
Open-market purchase | 45,000 | $4.97 | $223.7K |
| 2026-08-09 | Casner Jean |
Shares withheld for tax | 1,480 | $4.42 | $6.5K |
| 2026-06-01 | Roth Anthony M. |
Grant/award | 30,000 | — | — |
Well-known investors holding EMBC (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Yacktman Asset Management | 2026-06-30 | 4,315,952 | $14.1M | 0.17% | Added 18% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 976,587 | $3.2M | 0.0% | Added 195% |
| Millennium Management (Israel Englander) | 2026-06-30 | 945,968 | $3.1M | 0.0% | Reduced 41% |
| D. E. Shaw & Co. | 2026-06-30 | 650,070 | $2.1M | 0.0% | Added 22% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 446,091 | $1.5M | 0.0% | Added 14% |
| Renaissance Technologies | 2026-06-30 | 144,287 | $1.3M | — | Sold out |
| Two Sigma Investments | 2026-06-30 | 103,409 | $914.1K | — | Sold out |
| Tweedy, Browne | 2026-06-30 | 75,356 | $666.1K | — | Sold out |
| Gotham Asset Management (Joel Greenblatt) | 2026-06-30 | 17,386 | $153.7K | — | Sold out |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 20,236 | $66.0K | 0.0% | New position |