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We are a leading global medical device company focused on providing solutions to improve the health and well-being of people living with diabetes.
−Removed: In our close to 100-year history of our business, we believe that our products have become one of the most widely recognized and respected brands in diabetes management in the world.
−Removed: We estimate that our products are used by nearly 30 million people in over 100 countries for insulin administration and to aid with the daily management of diabetes.
+Added: As we approach our 100-year centennial, we believe that our products have become one of the most widely recognized and respected brands in diabetes management throughout the world.
+Added: We estimate that our products are used by more than 30 million people in over 100 countries for insulin administration and to aid with the daily management of diabetes.
We have a broad portfolio of marketed products, including a variety of pen needles, syringes and safety injection devices, which are complemented by our proprietary digital application designed to assist people with managing their diabetes.
−Removed: 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.
+Added: Our conventional 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.
−Removed: Our traditional and safety pen needles are compatible and frequently used with widely available pen injectors in the market today.
+Added: Our conventional 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.
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The diabetes care app serves as a channel for our support, education of and engagement with the diabetes community.
−Removed: In addition, we intend to explore strategic collaborative partnerships and acquisition opportunities that enable us to accelerate our growth.
+Added: In addition, we intend to continue to explore strategic collaborative partnerships and acquisition opportunities that enable us to accelerate our growth.
We intend to selectively pursue strategic collaborative opportunities that give us access to innovative technologies, complementary product lines, and new markets.
Global Operations
−Removed: Our global manufacturing, commercial team and distribution networks enable us to produce and distribute our products to end users and healthcare providers in over 100 countries.
+Added: Our global manufacturing and distribution network, together with our commercial team, enable us to produce and distribute our products to end users and healthcare providers in over 100 countries.
We have three manufacturing sites located in Ireland, the United States and China.
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We purchase all our raw materials and certain components from third-party suppliers.
−Removed: The primary materials that comprise our pen needles and insulin syringes are cannula, plastic resin, adhesive, needle lubricants, rubber stoppers and packaging material.
−Removed: We purchase some of these and other materials from a single or limited number of sources for various reasons, including quality assurance, cost-effectiveness, and continuity of supply, among others.
+Added: The primary materials that make up our pen needles and insulin syringes are cannula, plastic resin, adhesive, needle lubricants, rubber stoppers and packaging material.
+Added: We purchase most of these and other materials from a single or limited number of sources for various reasons, including quality assurance, cost-effectiveness, and continuity of supply, among others.
In connection with the Separation, we entered into a cannula supply agreement with BD, whereby BD sells to us cannulas for incorporation into our pen needles and syringes.
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The design and formulation of certain materials and components is proprietary and the intellectual property rights may be owned exclusively by one party.
−Removed: In the case of sole sourced parts, we manage risk through holding inventory ourselves and at the supplier to ensure continuity of supply and lower the risk of disruption.
+Added: In the case of sole sourced parts, we manage risk through holding inventory ourselves and at our suppliers' facilities to ensure continuity of supply and lower the risk of disruption.
Research and Development
Our strategy seeks to update and develop enhanced technology for our portfolio of current and future products by focusing on patient unmet needs and market expansion.
−Removed: As we develop these products we intend to apply for clearance from the U.S.
−Removed: Food and Drug Administration (the “FDA”) and similar regulatory authorities in jurisdictions outside of the United States.
+Added: As we develop these products we intend to apply for clearance from the United States Food and Drug Administration (the “FDA”) and similar regulatory authorities in jurisdictions outside of the United States.
For example, we are currently working on developing an insulin patch pump focused on serving the needs of people living with Type 2 diabetes.
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While no single patent or patent family is material to our business, our pen needle and syringe products contain features that are protected by a portfolio of utility and design patents, including features related to safety, comfort and ease of use.
−Removed: In addition, potential features of our insulin patch pump technology and finer gauge pen needle currently under development and software we market to end users for managing diabetes are covered by a variety of patents and patent applications.
+Added: In addition, potential features of our insulin patch pump technology currently under development and software we market to end users for managing diabetes are covered by a variety of patents and patent applications.
Generally, patent protection for these products and technologies is sought in the United States, Canada, Europe, China and Japan.
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As of September 30, 2023, we held about 750 patents in the United States and in various foreign countries in which we conduct business, as well as about 130 patents pending.
−Removed: The majority of our U.S.
−Removed: and foreign patents for individual products are in force for twenty years from the initial filing date.
+Added: The majority of our United States and foreign patents for individual products are in force for twenty years from the initial filing date.
The actual protection afforded by a patent, which can vary from country to country, depends upon the type of patent, the scope of its coverage and the availability of legal remedies in the country.
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We also compete with providers of insulin pumps and other insulin administration devices.
−Removed: We compete in the marketplace based on a number of factors, including product quality, clinical innovation, price, service and reputation.
+Added: We compete in the marketplace based on a number of factors, including product quality, clinical innovation, price, service, reputation and commercial excellence.
Changes in legislation or government policies, including with respect to licensing, health information privacy and data privacy and healthcare costs, reimbursement, coverage and access, can have a material impact on our worldwide operations.
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FDA regulations govern, among other things, product design and development, preclinical and clinical testing, pre-market clearance and approval, manufacturing, labeling, product storage, advertising and promotion, sales and distribution, post-market adverse event reporting, postmarket surveillance, complaint handling, repair or recall of products and record keeping.
−Removed: These regulations not only affect our existing markets products, but also our ability to market new products under development.
+Added: These regulations not only affect products in our existing markets, but also our ability to market new products under development.
For existing and potential new products, failure to comply with ongoing regulatory requirements can result in enforcement actions by the FDA and other regulatory agencies, which may include warning letters that require corrective action, fines, injunctions, rescissions of previously granted clearances and/or approvals and other penalties.
−Removed: We maintain a robust FDA Quality System Regulation and ISO Quality Systems that establish standards for our product design, manufacturing, and distribution processes, inclusive of Current Good Manufacturing Practices.
+Added: We maintain robust FDA Quality System Regulation and ISO Quality Systems that establish standards for our product design, manufacturing, and distribution processes, inclusive of Current Good Manufacturing Practices.
The FDA and other regulatory agencies engage in periodic reviews and inspections of our quality systems, as well as product performance and advertising and promotional materials.
As a medical device manufacturer and distributor, our manufacturing facilities and the facilities of our suppliers are subject to periodic inspection by the FDA, certain corresponding state agencies, and other regulatory bodies.
−Removed: Prior to marketing or selling most of our products, we must secure approval from the FDA and counterpart non-United States regulatory agencies.
+Added: Prior to marketing or selling most of our products, we must secure clearance or approval from the FDA and counterpart non-United States regulatory agencies.
These regulatory controls, as well as any changes in agency policies, can affect the time and cost associated with the development, introduction and continued availability of new and existing products.
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Agreements that Embecta entered into with BD that govern aspects of Embecta's relationship with BD following the Separation include, but are not limited to:
−Removed: • Transition Services Agreements ("TSA") - Pursuant to the TSA, Embecta and BD and their respective affiliates provide each other, on an interim, transitional basis, various services, including, but not limited to, information technology, procurement, quality and regulatory affairs, medical affairs, tax and treasury services.
+Added: • Transition Services Agreements ("TSA") - Pursuant to the TSA, and the related Logistics Services Agreement (“LSA”), Embecta and BD and their respective affiliates provide each other, on an interim, transitional basis, various services, including, but not limited to, information technology, procurement, quality and regulatory affairs, medical affairs, tax and treasury services, distribution logistics, and shared services infrastructure support for order-to-cash, source-to-pay, and record-to-report (collectively, the “Interim Business Continuity Processes”).
The agreed-upon charges for such services are generally intended to allow the servicing party to charge a price comprised of out-of-pocket costs and expenses and a predetermined profit in the form of a mark-up of such out-of-pocket costs and expenses.
−Removed: The services will terminate no later than 24 months following the Separation.
The service recipient may terminate any services by giving prior written notice to the provider of such services and paying any applicable wind-down charges.
+Added: Such services provided pursuant to the TSA were to terminate no later than April 1, 2024, 24 months following the Separation, and such services provided pursuant to the LSA were to terminate no later than January 1, 2024, which BD has agreed to extend through March 31, 2024.
+Added: However, BD has granted a limited extension until November 1, 2024 of certain services under the TSA, LSA and other transaction documents in a limited set of markets (the "Extension") to support the Interim Business Continuity Processes, subject to the condition in the next sentence.
+Added: The Extension is conditioned upon BD obtaining a supplemental private letter ruling to the private letter ruling that it received in connection with the Separation and the distribution, in form and substance reasonably satisfactory to BD (the "Supplemental PLR").
• Distribution Agreements - Embecta and BD entered into distribution agreements for certain territories, principally in the Asia Pacific Region and Latin America, whereby a subsidiary of BD has been appointed as a distributor of Embecta or its relevant subsidiaries to support certain commercial operations of the diabetes care business on a transitional basis in these regions for a maximum of two years.
−Removed: The distribution agreements will each continue until either (1) certain governmental approvals needed to distribute products in the defined territory are obtained and order-to-cash processes and other services of the Company for such territory are migrated to an alternative commercial arrangement between the parties or (2) the applicable services are transitioned to a third-party distributor or independently performed by Embecta, but in any event no longer than the maximum term of two years.
+Added: The distribution agreements will each continue until either (1) certain governmental approvals needed to distribute products in the defined territory are obtained and order-to-cash processes and other services of the Company for such territory are migrated to an alternative commercial arrangement between the parties or (2) the applicable services are transitioned to a third-party distributor or independently performed by Embecta, but in any event no longer than the maximum term of two
+Added: years, except certain such agreements may be extended in connection with the Extension.
Embecta shall pay BD a return of 1.5% to 2.0% of net revenue for each territory.
−Removed: • Cannula Supply Agreement - Embecta and BD entered into a cannula supply agreement whereby BD sells to Embecta cannulas for incorporation into Embecta's existing syringes and pen needles, safety syringes and safety pen needles, and insulin patch pump, pen needles and safety pen needle currently under development.
+Added: • Cannula Supply Agreement - Embecta and BD entered into a cannula supply agreement whereby BD sells to Embecta cannulas for incorporation into Embecta's existing syringes and pen needles, safety syringes and safety pen needles, and products currently under development.
BD retains ownership of all cannula technology, cannula production activities and the intellectual property rights therein.
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however, such termination can be effective no earlier than five years from the Separation.
−Removed: The cannula supply
−Removed: agreement will be terminable by BD without cause by providing at least 36 months’ written notice;
+Added: The cannula supply agreement will be terminable by BD without cause by providing at least 36 months’ written notice;
however, such termination can be effective no earlier than ten years from the Separation.
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and (vi) entering into any other corporate transaction which would cause Embecta to undergo a 50% or greater change in its stock ownership.
−Removed: • Logistics Services Agreement - Embecta and BD entered into a logistics services agreement whereby BD provides Embecta with certain order-to-cash and logistics services to support certain commercial operations for a maximum term of two years.
−Removed: Embecta will pay BD (i) reimbursable costs, including all shipping costs, selling costs, general administration costs, costs of goods, research and development services costs, and other income and expenses related solely to the diabetes care business, that are incurred by BD directly, as allocated costs or as costs payable to a third party and (ii) a monthly administrative fee of 1.0% of net revenue.
+Added: • Logistics Services Agreement - Embecta and BD entered into a logistics services agreement whereby BD provides Embecta with certain order-to-cash and logistics services to support certain commercial operations for a maximum term of two years, which BD has agreed to extend through March 31, 2024.
+Added: Embecta will pay BD (i) reimbursable costs, including all shipping costs, selling costs, general administration costs, costs of goods, research and development services costs, and other income and expenses related solely to the diabetes care business, that are incurred by BD directly, as allocated costs or as costs payable to a third party and (ii) a monthly administrative fee of 1.0% of net revenue (which will increase to 1.25% of net revenue after January 1, 2024).
• Other agreements that Embecta entered into with BD include, but are not limited to, an employee matters agreement, an intellectual property matters agreement, local support services agreements, certain other manufacturing arrangements and a process services agreement and lease agreement for a manufacturing facility location in Holdrege, Nebraska.
Human Resources ("HR")
−Removed: As of September 30, 2022, we had approximately 1,900 regular employees globally (approximately 2,200 if deferred closing countries are included – China, Mexico, Italy), with approximately 900 employees in the United States.
+Added: As of September 30, 2023, we had approximately 2,200 regular employees globally (which includes deferred closing countries), with approximately 925 employees in the United States.
Our talented employees are an integral reason for our standing as one of the world's leading diabetes care companies.
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Our mission of developing and providing solutions to make life better for people living with diabetes helps us attract potential employees interested in making a difference to the world.
−Removed: As we exit our transition service agreements with BD and stand up our own Embecta HR Operations and Service Delivery model, we have the unique opportunity to integrate Environment, Social, Governance ("ESG") as well as Inclusion, Diversity and Equity ("ID&E") principles into the foundation of our HR practices.
−Removed: We believe that we are seen as an employer of choice and we focus on providing a personalized experience from the moment an employee considers joining the Embecta team.
−Removed: In addition to helping make life better for people living with diabetes, our employee value proposition includes factors such as a strong rewards package, a focus on development, and engaging with our employees as we shape our new company together.
−Removed: At Embecta, our Total Rewards programs enable behaviors that drive performance, reward for results and create long-term value for our stockholders and employees.
+Added: As a new company, we have the unique opportunity to integrate Environment, Social, Governance ("ESG") as well as Diversity, Equity & Inclusion ("DE&I") principles into the foundation of our HR practices.
+Added: We focus on providing a personalized experience from the moment an employee considers joining the Embecta team.
+Added: In addition to helping make life better for people living with diabetes, our employee value proposition includes a strong rewards package, a focus on development, and engaging with our employees as we shape our new company together.
+Added: At Embecta, our Total Rewards programs enable behaviors that drive performance, reward results and create long-term value for our stockholders and employees.
We continually monitor our programs and policies to ensure they are competitive and have a clear link to our business and talent strategy.
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Our employee benefit programs provide flexibility and choice, and enrich the health, well-being and security of our employees.
−Removed: We are building a learning culture where employees at all levels of the organization are encouraged to grow and improve, including company-wide training on our Code of Conduct, job related technical training, and easy access to virtual on demand learning.
−Removed: At Embecta, long term succession planning and capability building are integral to our talent practices that
−Removed: are aimed at helping our employees be the best versions of themselves while simultaneously building our future talent pipeline.
−Removed: All employees are encouraged to establish individual, team and development goals in partnership with their manager to ensure clarity and alignment while retaining focus on growth and development.
+Added: We are building a learning culture where employees at all levels of the organization are encouraged to grow and improve, including company-wide training on compliance, job related technical training, leadership development, and easy access to virtual on demand learning.
+Added: At Embecta, long term succession planning and capability building are integral to our talent practices that are aimed at helping our employees be the best versions of themselves while simultaneously building our future talent pipeline.
+Added: All employees are encouraged to establish individual, team and development goals in partnership with their manager to ensure clarity and alignment to our business goals while retaining focus on growth and development.
In alignment with our continuous improvement culture, we seek feedback through surveys and other means so that employees can share their perspectives on ways to continuously improve our workplace climate.
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What we do at Embecta is personal to Embecta employees, and our HR practices are designed to enable our employees in fulfilling our mission of helping people with diabetes.
−Removed: Inclusion, Diversity & Equity
−Removed: Embecta engages a workforce that reflects the communities it operates in.
−Removed: Our workforce possesses a broad range of thoughts and experiences, starting with a diverse leadership team and board of directors.
−Removed: Our commitment to ID&E is embedded in our values.
−Removed: We believe that diversity of our teams makes us better at identifying opportunities and solving problems.
−Removed: We are committed to creating and sustaining an environment where everyone brings their authentic selves to work, to help us fulfil our mission of helping people with diabetes.
−Removed: Corporate Responsibility ("CR") and ESG
−Removed: As part of the Separation from BD, Embecta is in process of developing a standalone multi-year strategy to advance its ESG initiatives.
−Removed: The focus in fiscal year 2022 was primarily evaluation, as Embecta’s risks and impacts are different to those of BD.
+Added: Diversity, Equity & Inclusion
+Added: Embecta engages a workforce that reflects the communities where we operate.
+Added: Our workforce, including our leadership team, and our board of directors, includes diverse members and teams.
+Added: Our commitment to DE&I is embedded in our values.
+Added: We believe that employee diversity makes us better at identifying opportunities and solving problems.
+Added: We are committed to creating and sustaining an environment where everyone brings their authentic selves to work, to help us fulfill our mission of helping people with diabetes.
+Added: Corporate Responsibility ("CR") and Environmental, Social and Governance ("ESG")
+Added: Embecta is in the process of developing a standalone multi-year strategy to advance its ESG initiatives.
+Added: The focus in fiscal year 2023 was to evaluate Embecta’s global ESG risks and impacts.
This evaluation phase commenced with a Sustainability Materiality Assessment and an internal review of the United Nations Sustainable Development Goals.
Separately, the governance structures for managing ESG topics and updates were documented via the Company's Enterprise Risk Committee charter.
−Removed: Embecta plans to publish its inaugural Sustainability Report in mid fiscal year 2023.
+Added: Embecta plans to provide an updated Sustainability Report during its 2024 fiscal year.
Available Information
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.