Good morning, everyone, and welcome to Embecta's first-ever Analyst and Investor Day. My name is Pravesh Khandelwal , and I am the Vice President of Investor Relations. The slides that accompany today's event and webcast replay details are available on the Investor Relations section of our website at www.embecta.com. Before we begin, I would like to remind you that some of the matters discussed in the event will contain forward-looking statements regarding future events as outlined in our slides. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our introductory slide today, as well as our filings with the SEC, which can be accessed on our website.
In addition, we will discuss certain non-GAAP financial measures in this presentation, which should be considered a supplement to and not a substitute for financial measures prepared in accordance with GAAP. A reconciliation of these non-GAAP measures to the comparable GAAP measures is included in the appendix section of this presentation. Our objectives today are threefold: deepen your understanding of our business and the drivers of our leadership position, interact with a wider set of key leaders from our management team, lay out targets for the three-year long-range plan period through fiscal year 2028, which we will refer to as the LRP period during the day. As you can see from the agenda, we have a lot of ground to cover today. We'll start with Dev Kurdikar, President and CEO of Embecta. Dev Kurdikar will begin by sharing an overview of Embecta and our strategic priorities.
Following the executive summary, you will hear from members of the Embecta leadership team who will cover our market trends, portfolio, and commercial strategies across the U.S. and international regions, along with a look into our manufacturing and supply chain operations. Next, Dev Kurdikar and Ginny Blocki, our Head of Strategy, will walk through our value creation opportunities, followed by Jake Elguicze, our Chief Financial Officer, who will close the day with a review of our financial outlook and long-term objectives. Throughout the day, we will host Q&A sessions with the Embecta presenters. Please keep your questions focused on the topics covered immediately preceding that session. For those joining us in person, after the formal presentations, the leadership team will be available during lunch outside the main venue. Additionally, we will be showcasing our current products in the new Embecta packaging in the room called the Studio, which is right outside the room.
We encourage you to stop by during the breaks or after the presentations for a hands-on experience. Finally, we have a 10-minute break built in throughout the day. This will give you a chance to stretch your legs, grab a coffee, or explore our product display. With that, moving to the next slide, we have an experienced leadership team with us here today that you may not have met before. Ginny Blocki , as I mentioned earlier, is our Head of Strategy. Tom Blount leads our U.S. and Canada business. Slobodan Radumilo oversees our businesses in all other markets around the world. Shaun Curtis leads manufacturing, supply chain, and quality. Jeff Mann at the back is our General Counsel and oversees key technical functions, including R&D, regulatory affairs, and medical affairs. Jean Casner, also at the back, is our Chief Human Resources Officer.
It is my pleasure to introduce Embecta's President and Chief Executive Officer, Dev Kurdikar Kurdikar.
Thank you, Pravesh Khandelwal. I'm pleased to welcome all of you who've joined us in person and virtually today for this special event, our first Analyst and Investor Day since we became an independent company three years ago. We brought with us a century of experience, innovation, and product leadership in insulin injection when we spun off from BD in 2022. That is the source of a stable, recurring, and geographically diversified revenue base with an outstanding margin profile and strong cash flow generation. With over 8 billion units produced each year, we are the world's number one producer of Pen Needles and insulin syringes for the diabetes care market, serving over 30 million people per year in more than 100 countries worldwide. The products we manufacture are non-elective, chronic use products for people with diabetes who need to inject insulin to manage their glucose levels.
Thanks to our manufacturing proficiency, efficient distribution network, and experienced global commercial team, we've built a strong reputation for providing the best-in-class medical-grade products, earning the trust of millions of people with diabetes and healthcare professionals throughout the world. This global infrastructure, coupled with a reputation earned over 100 years, provides a solid foundation for us to build upon. Turning to the next slide, as you can see, we hold the number one position globally across the three product categories of our best-in-class injection portfolio, with a significant share in each category. Most notably, we hold approximately 50% share of the global pen needle category. This includes our Nano 2nd Gen and Ultra-Fine products. For the safety portfolio, which includes both Safety Pen Needles such as AutoShield Duo and safety insulin syringes, we hold about 60% share.
In the insulin syringe category, which includes the Ultra-Fine syringes shown here, we hold approximately 40% share. These are leadership positions that have been consistently maintained year over year. Together, Pen Needles and Safety Pen Needles account for approximately 84% of our total revenue. We will go into greater detail on the key channels, geographies, and product lines within these categories later in today's program. First, let's turn to the next slide, which showcases the facilities that manufacture these high-grade medical products. A core strength we are especially proud of is our robust global manufacturing infrastructure and associated capabilities. Across our three highly automated plants , we produce over 8 billion units annually, with capacity for further expansion. On to the next slide. Establishing our own global distribution network has been one of the most critical projects in standing up Embecta as an independent organization.
Doing so not only allowed us to design a network that was tailored for our own needs, both today and in the future, it also gave us an opportunity to simplify and reduce the overall complexity of the network. We have 16 distribution centers strategically located to support our three manufacturing sites and the more than 100 countries we serve today. Now, let's turn to the next slide and discuss our commercial reach. Our commercial team is comprised of more than 500 employees globally. Notably, more than half of that team is dedicated to emerging markets, which presents the biggest growth opportunity for our core injection business. Our marketing and sales professionals' goal is to ensure broad market access and to build and maintain relationships with the market-appropriate combination of retailers, payers, healthcare providers, and distributors.
What's common across all markets is that our products are the trusted brand for key stakeholders driven by strong product brand recognition, high quality, and demonstrated reliable supply. Moving on to the next slide. Our revenue base is geographically diversified across developed and emerging markets. However, more than 80% of our revenue comes from seven key markets: the U.S. alone, which accounts for 54% of our total revenue; Canada, France, Germany, and Japan, which are a part of what we refer to as developed markets and which account for approximately 29% of our total revenues; and Canada and Mexico, which are part of the emerging markets category on the right side of the slide, which accounts for approximately 17% of our fiscal 2024 reported revenue. As you can see, the majority of our business in the U.S. and developed markets is in Pen Needles.
In the emerging markets, and this is especially true in Mexico, there is a higher portion of insulin vial use, which drives greater syringe use as compared to developed markets. We believe our strong presence in emerging markets provides us the opportunity to grow, given the anticipated significant growth in people with diabetes in these markets. Let's move to the next slide. As you see here, since 2019 through 2024, a time period which has included the COVID pandemic, the increased penetration of pumps, and the rapid adoption of GLP-1 treatments, and the spinoff and standup of our company, our business has been stable and resilient. We have maintained our leadership position through strong brand quality and recognition, clinical leadership, and production strength.
-As I mentioned earlier, approximately 84% of our injection revenue comes from Pen Needles and Safety Pen Needles, which we believe will continue to be stable and growing product categories for us. The performance in these categories has offset a continuing decline in syringes, particularly in the U.S. This decline is due to a shift from insulin vials to insulin pens as a preferred delivery format, as well as some contribution from patient mortality, as older patients who are more likely to have used insulin vials have passed away, whereas new patients are more likely to be started on insulin pens. On the next slide, let me walk you through our strategic roadmap. We have adopted a phased approach to our goal of repositioning Embecta for long-term sustainable growth. These phases, standup, seed growth, and transform, are intended to transition Embecta back to growth.
It is a multi-year framework designed to help us achieve our goal of transitioning from our roots as a carved-out insulin injection delivery company toward our goal of becoming a more diversified, broad-based medical supplies company. Starting with 2022, at the time of the spin, we were faced with foundational challenges: standing up a new team and organization, navigating through macroeconomic headwinds, and operating under multiple transition service agreements with $1.65 billion in gross debt on the balance sheet. Phase I, standup, has been our focus from 2022 through 2024. During this period, we've stabilized operations, implemented ERP and shared services, and largely established Embecta as a standalone eity. Even as we did so, I'm proud to say that we exceeded our revenue and EBITDA targets that were set pre-spin.
These accomplishments occurred in a challenging macro environment that was not contemplated at the time of spin, including historically high inflation, a rapidly rising interest rate environment, geopolitical conflicts, and supply chain and labor issues. These results demonstrate our ability to navigate complexity while delivering value to customers and shareholders. As we look at where we are today, we are operating as an independent company. We have started paying down debt, launched cost reduction initiatives, and exited most TSAs, positioning us for the next phase of our strategy. We made a strategic shift. We terminated our patch pump program. phase II, seed growth, is expected to last about three years. We will focus on our goals of staying competitive in our core portfolio, expanding into adjacent categories, and creating financial flexibility for opportunistic growth investment by reducing our net leverage.
This is also the phase where we expect to begin to pivot towards expanding our product portfolio beyond insulin delivery via injections. Phase III, transform Embecta, begins in 2028 and beyond, envisions Embecta to be a broad-based medical supplies company that serves people beyond those solely with diabetes. This is a high-level overview of where we are going. In the presentations that will follow, we'll talk about specific initiatives that underpin this roadmap. First, let us ground ourselves in three key strategic priorities that are part of the current phase. Next slide, please. The first of these is strengthening our core business. We are working on our goal to execute a seamless brand transition to ensure our identity resonates globally while maintaining the trust of our customers.
This process is already underway in the U.S. and Canada, and it's expected to roll out in phases in the rest of the world over the next couple of years. At the same time, we are continuing to explore opportunities within our core portfolio that bolster our leadership position across insulin devices. Second, expanding our product portfolio. We believe we are well positioned to introduce market-appropriate products that leverage our expertise in high-volume manufacturing and the strength of our global commercial channel. Such initiatives potentially include utilizing our capabilities to manufacture products for partners that already have a commercial channel, as well as using our global commercial presence to sell products manufactured by others. Third, increasing our financial flexibility. This began with the decision to discontinue our insulin patch pump program and the related restructuring plan intended to generate significant cost savings.
We also executed additional cost optimization initiatives with the intention of bolstering our margin outlook. We are prioritizing debt reduction, including a plan to pay down approximately $110 million in debt during 2025. Importantly, given the free cash flow generation capabilities of the company, coupled with the fact that cash used towards standup activities is largely behind us, we expect to be able to materially reduce our outstanding debt during the next several years, thereby enhancing our financial agility. The successful execution of these priorities will position us for sustainable success as we continue to evolve and transform Embecta for the future. With that, let me open up the forum for Ginny Blocki, Tom Blount, Slobodan Radumilo, and Shaun Curtis to take you through our business. Thank you, Ginny Blocki.
Thank you, Dev Kurdikar. Good morning. I am Ginny Block , and I'm the Senior Vice President of Strategy. It's a pleasure to be here today. Let's turn to the next slide to continue the discussion. The International Diabetes Federation recently issued the 11th edition of their Diabetes Atlas, and the latest data through 2024 continues to show that diabetes is a global pandemic. An estimated 589 million adults aged 20 years- 79 years old are living with diabetes. This represents approximately 11% of the world's population in this age group. The projections are staggering. The estimated number of adults with diabetes is predicted to rise to 853 million by 2050.
What we also learned is that diabetes prevalence rates for adults 20 years- 79 years old are increasing around the globe with notable increases in emerging markets, taking the global prevalence for adults 20 years- 79 years old from approximately 10% in 2021 to about 11% in 2024, with the anticipated prevalence to be approximately 13% in 2050. As importantly, diagnosis and treatment rates in emerging markets like China, India, Brazil, and Mexico are rising due to a number of factors. One of which of these is markets have higher population growth, and as their economies expand, they are seeing changes in lifestyle and access to medical care. Also, it is projected that the vast majority of the net new growth in the number of people with diabetes will occur in the emerging markets. Currently, approximately four out of five adults with diabetes live in the emerging markets.
Of the people with diabetes globally, approximately 65 million-75 million people are on insulin therapy to help manage their diabetes, with approximately 2/3 in the emerging markets. We have built a strong emerging markets infrastructure to serve this growing population with about 430 employees in 19 sales offices and our manufacturing plant in Suzhou, China, along with seven distribution centers. All of this helps to ensure customers and people with diabetes receive product where they need it, when they want it. We believe this local infrastructure enables us to support customers in this region and serve the anticipated growth in the number of people with diabetes. Turning to the next slide. Insulin remains the standard of care as diabetes progresses, even as treatments like GLP-1s have begun to replace older therapies such as sulfonylureas, DPP-4 inhibitors, and thiazolidinediones.
People with type 1 diabetes require insulin to survive. Upon diagnosis, they start basal and bolus insulin therapy immediately and typically inject four or more times each day. Later, they may move to pump to help manage their insulin therapy, although that is less common outside of the U.S., where the majority of people continue with multiple daily injections. This is likely to remain the case for some period of time due to the lack of reimbursement for infusion pumps in several markets. Globally, there are approximately 9 million people with type 1 diabetes based on the International Diabetes Federation 2024 estimates and the T1D index. For type 2 diabetes, what has changed over time is the treatment approach itself. More recently, the American Diabetes Association guidelines focused on a more person-centered approach that accounted for comorbidities.
With that in mind, they recommended GLP-1 therapy as a first-line treatment approach along with other oral therapies, given the benefits beyond glucose control. However, as the disease progresses and beta cell function declines, people with type 2 diabetes will generally move to insulin therapy, whether it's basal only or basal and bolus. Based on the most recent International Diabetes Federation data and our internal analysis, we estimate there are approximately 55 million-65 million people with type 2 diabetes using insulin. As we move to the next slide, we'll discuss key considerations for GLP-1 therapy in treating type 2 diabetes. GLP-1 therapy has a place within the treatment paradigm. However, there are some important things to consider regarding their use. They are often used in combination or as a step therapy to other diabetes therapies, including insulin.
They have been shown to be effective for glycemic control, and we know GLP-1 therapies lower glucose more effectively when insulin is present. They also have been shown to reduce the associated health risks, such as cardiovascular disease, kidney disease, and more. However, clinical evidence has shown that over time, patient adherence has been low. There are some notable side effects, access issues, and very high costs associated with GLP-1 therapy use. Perhaps most importantly, diabetes is a progressive disease, and GLP-1 therapy has not demonstrated the ability to reverse this progression. As such, we do not expect GLP-1 therapy to replace insulin use for people with diabetes. In fact, global data shows there is a slight growth in insulin.
As the disease progresses, people with type 2 diabetes may move on to insulin therapy either as concomitant therapy with GLP-1s or as a single daily injection or multiple daily injections. Next slide, please. As we look at the left-hand side of the slide, we can see globally there is slight growth overall for insulin standard units, which is driven by insulin pens. We also see significant growth of weekly GLP-1 therapy standard units, while daily GLP-1 therapy standard units are declining. We know GLP-1 therapy has been available for several years. Over that time, prescription trends globally have remained relatively consistent for insulin, which demonstrates insulin remains an important treatment option for people with diabetes, even with the availability of GLP-1 therapies. Now, if we go to the next slide, we expect multiple daily injections to remain a critical component within the standard of care.
This is true in the U.S., developed markets, and the emerging markets. In the U.S., we recognize some people with diabetes may move to pump therapy, generally those with type 1 diabetes. Current pump penetration for people with type 1 diabetes is somewhere in the high 30%- 40%, and some estimates show pump penetration in the U.S. could reach about 50%-60% over a period of time. However, even those on pump therapy continue to have a backup plan and are ready to use injection therapy when their pumps fail or when they are looking to take a pump holiday. Those with type 2 diabetes that move to pump therapy typically do so after being on multiple daily injections for a period of time.
Current pump penetration for type 2 insulin-intensive people with diabetes is in the mid-single digits, and some estimates show it could reach about 20%-25% of type 2 insulin-intensive patients over a period of time. In the developed markets, pump penetration is anticipated to be lower than in the U.S. for people with type 1 diabetes and significantly lower for people with type 2 diabetes. In the emerging markets, the vast majority of insulin administration will continue to be via injection, given the alternatives are simply not affordable to the majority of people with diabetes. Beyond the cost of pump therapy being quite a bit more than injection therapy, there are a number of reasons why the majority of people with diabetes will continue to administer insulin via injection. Some people will not want to wear the disease.
Pumps mean they have a device attached to their body 24/7. For many, it also means having to wear a continuous glucose monitor on their body, so they will be wearing two devices all of the time. A pump is a technologically device, and some people prefer the simplicity of an injection. For many, injection therapy can deliver sufficient glycemic control. In fact, as you will see later when we discuss the U.S. business, in spite of pump penetration in type 1 rising from an estimated high 20%-30% in 2019 to an estimated high 30%-40% in 2024, our U.S. business has remained stable. As we turn to the next slide, I'll highlight key products in the Embecta portfolio. Embecta Pen Needles have a long legacy around the world.
They are known for being of high quality as well as having consistent and reliable supply. While there are many competitors in our categories, Embecta Pen Needles have several key points of differentiation versus the competition. Our pen needle portfolio is quite extensive. We offer a vast array of needle lengths and gauges. We are also the only company that makes a contoured needle base, which developed and is a patented technology. We have learned a lot over our long history in insulin injection and have found that people with diabetes can inject with a variety of different forces. The contoured base pen needle can help correct for too much injection force and provide a more consistent injection depth. This is important in getting the insulin into the subcutaneous fat where it is intended to be injected as opposed to into the muscle.
Injecting into the muscle can lead to pain and greater risk of hypoglycemia. We also offer ultra-thin wall technology, which is the highest international standard for pen needle inner diameter. Studies have shown that this results in greater ease of use and increased confidence that the complete insulin dose has been delivered. Also, our Pen Needles are compatible with widely used pen devices around the world that are used for insulin, as well as other drugs such as GLP-1 therapies. Importantly, we have consistently shown that we have high-quality products as well as reliability of supply, which has helped us continue to be a leader globally. Let's go to the next slide. You can see that we also are number one in the insulin syringe category, which we pioneered over 100 years ago.
Our portfolio includes a wide variety of syringes in terms of needle lengths and barrel sizes, accommodating different types of insulin strengths, whether it be U-100, U-500, or U-40. We offer thin wall and regular wall technology, and the syringes come in poly bags or individually sealed in blister packs. They are available in both small and larger count packaging, which addresses the needs in both emerging developed markets. Key points of differentiation include high-quality products and reliability of supply. We have been in the syringe market for over 100 years, starting developing the first insulin syringe in 1924. This long legacy has made our products a standard of care in many markets. Finally, we are recognized as an education resource for injection technique. There are some competitors in this space, some national, but many local players depending on the market.
However, Embecta insulin syringes are the number one brand globally. As we turn to the next slide, I'll share information on our safety products. Our safety products include Safety Pen Needles and safety insulin syringes, which are typically used when insulin delivery is carried out by a healthcare professional rather than by the patient. For Safety Pen Needles, we have AutoShield Duo, which is a dual-ended Safety Pen Needle. Key points of differentiation include the passive protection on both needle ends to protect against the risk of needle stick injuries and blood-borne contamination for the healthcare professional. Our safety insulin syringes are well known in the market and come in 6 mm, 8 mm, and 12.7 mm needle lengths with single-handed safety activation to cover the needle after use to reduce the risk of needle stick injuries.
We are proud of our reputation for high-quality products, reliability of supply, and the training and education that we provide to customers and people with diabetes. Let's go to the next slide to summarize. Diabetes continues to be a significant health concern globally, and Embecta is well positioned for growth in all markets, including the emerging markets. Insulin will remain a treatment option as diabetes progresses. As we discussed, global insulin trends remain stable. Injections are expected to remain the standard of care in developed and emerging markets. Lastly, as I shared, Embecta holds the number one position globally across Pen Needles, insulin syringes, and our safety portfolio, including Safety Pen Needles and safety insulin syringes. We are proud of our comprehensive portfolio and injection products, which meet the needs of people with diabetes around the world.
Now I'll turn it over to Tom Blount to discuss the U.S. business and strategy. Tom Blount.
Thank you, Ginny Blocki. I'm Tom Blount Brown, Senior Vice President and President of the U.S. and Canada business. I'm excited to join you today to walk you through Embecta's business in the U.S., which is our largest by far. Let's turn to the next slide to get started. As Dev Kurdikar mentioned earlier, the U.S. accounts for about 54% of our overall revenue. We continue to maintain a strong leadership position in this market, and this success is grounded in our highly strategic and differentiated commercial approach, one that's tightly aligned to the needs of our customers segments. There are a significant number of people with either type 1 or type 2 diabetes who are on insulin today.
Let's talk about the more than 20 million people that have been diagnosed but are not yet currently on insulin. These are people that are somewhere along the disease progression path that Ginny Blocki discussed earlier. They might be on an oral therapy such as metformin or a GLP-1, but as their diabetes progresses and their beta cell function decreases, they will generally progress to daily insulin injections. There are also a significant number of people who have not yet been diagnosed. They too will ultimately progress through therapies and eventually to insulin. As we've seen the most recent International Diabetes Federation data, these numbers are only increasing in the years ahead. When we look at our go-to-market strategy in the U.S., one of our key strengths is that we have a comprehensive approach with products available in all key channels.
The retail pharmacy represents a critical channel through which the majority of our business runs. In this channel, we are highly focused on widespread availability to support a seamless experience for the pharmacy and the patient. We also advance our full portfolio of conventional and safety products through other important channels such as mail, long-term care, acute care, and customers. Our distribution to all these channels is supported by an established network of drug wholesalers, retailers, and medical distributors. We work closely with payers and pharmacy benefit managers to ensure that people with diabetes have affordable access to our products. Over the many decades that we have been serving the U.S. market, we developed unparalleled payer coverage and established strong relationships with all channel partners.
We continue to focus on our goal of creating a stable environment where people with diabetes can get affordable access to our products and receive appropriate education across the continuum of care, whether that be with their healthcare professional, at retail, or via other channels such as digital. We ultimately expect to leverage our commercial infrastructure to not only support our current business, but also to unlock new growth through commercial partnerships and distribution agreements. We are actively seeking such opportunities. On the next slide, let's talk through the makeup of our retail channel. As I just mentioned, the majority of the U.S. business is through the retail pharmacy channel, which represents a critical component of our overall success and strategic performance. National retailers are the largest component of this channel for us at approximately 80% of sales.
The rest of our U.S. retail business is split among the regional chains as well as small chains and independent pharmacies. Over our many years serving the market, developed some unique insights that we believe are critical in how we go about executing in this channel. Beyond healthcare providers and educators, pharmacists play an important role around injection technique and proper needle use, given their accessibility to people with diabetes. As a result, where possible, we make providing education a key part of our partnerships with retailers, which helps address what we believe to be a major unmet need in the market. For example, we know that Pen Needles are not always dispensed to people with diabetes who are picking up their insulin. It's critical to have enough supplies on hand to support appropriate injection needs.
Therefore, we've taken steps to better educate our retail partners around proper needle supply. We incorporate all these insights into how to differentiate and add value with customers, retail partners, and consumers. Let's see about more of that on the next slide. Whether initiating or already on insulin therapy, many people with diabetes often feel overwhelmed with all the responsibilities they need to juggle. To help address unmet needs around the injection experience, we have supported and implemented numerous patient support and education initiatives, both at the account level with our retail partners as well as through national programming with third-party vendors. Some examples of these initiatives include direct-to-patient text messaging programs, patient counseling programs, instructional videos, pharmacist messaging at the point of dispensing, and messaging to go with a prescription bag.
These programs provide information to help support the best injection experience and ongoing adherence, while also reinforcing the importance of having enough supplies. One example that you can see here is a refill reminder text program, which sends a message to patients late to refill and reinforces the importance of having adequate supply of Pen Needles and using a new needle for each injection, along with providing a link to additional video content. Our research has shown that when patients do not have enough Pen Needles, they may reuse or skip injections. Therefore, we believe messages like these are very important to address this issue. Turning to the next slide. At Embecta, our goal is for patients to have unrestricted access to our products. We are proud to report that approximately 96% of all covered lives in the U.S. have access to our portfolio.
As shown on the left, the total U.S. insured population is about 315 million lives, with coverage spanning across commercial, Medicaid, and Medicare Part D. While we are covered with 96% of these lives, we have advantaged or inclusive access to over 146 million lives, representing a significant portion of our U.S. business. This widespread coverage is the result of our ongoing work with payers and PBMs to maintain broad and reliable access across all key channels. Whether it is commercial plans, Medicaid, or Medicare, we are actively strengthening our relationships to achieve our goals of patients having convenient and affordable access to our products. In our negotiations with payers, PBMs, and retailers, we believe it is important to serve the market with high-quality products, which we believe serves as an important differentiator.
Lastly, payer access also helps simplify pharmacy operations, ensuring patients can pick up their prescriptions with the lowest out-of-pocket cost. Turning to the next slide, let's dive deeper into our payer coverage. As Ginny Blocki mentioned earlier, type 2 diabetes is a progressive disease, and people will generally move to insulin therapy over time. While 12% or so of the U.S. population has diabetes, the prevalence rises to around 29% among those aged 65 and older. Although Medicare represents less than 20% of our covered lives, we estimate that over half of our U.S. retail business is adjudicated as a Medicare Part D benefit. Medicare Part D enrollment is expected to increase from the 55 million in 2025 to 65 million by 2034. We anticipate that this growing expansion will provide a growing opportunity for our business.
In fiscal year 2024, we made meaningful progress by successfully negotiating preferential access to our products with three Medicare Part D providers, resulting in preferred access to our products. This was a key step in ensuring Medicare patients on insulin continue to have unrestricted access to our products and gives us a strong foothold in a segment that is only expected to grow. Additionally, a third of our business is processed through commercial insurance and about 15% through Medicaid. Ultimately, our broad access across these segments is an enabler of our ongoing stability. On the next slide, we illustrate prescription trends in the U.S. and how that is reflected in pen needle units. We routinely review relevant diabetes care market trends.
Some trends that frequently are top of mind for us are the continued expansion of GLP-1s and insulin pumps, in addition to the prescription trends in insulin vials and pens. GLP-1 and pump adoption has increased significantly over the period shown here. Pen insulin prescription volumes have stayed flat, while vial insulin use has declined. Factors impacting the trends in pen and vial insulin prescriptions include people with diabetes switching from vials to pens, vial users passing away but not being replaced at the same rate with new vial users, and insulin pumpers using vials to fill pump cartridges. During the same period, our U.S. pen needle units have grown at a 4% CAGR, while our syringe units have declined in line with vial decline. This data reinforces the stability of our pen needle category and reflects some competitive share gain for both Pen Needles and syringes. Next slide, please.
Our U.S. commercial strategy has allowed our U.S. revenue to be relatively stable over the last few years. Our pen needle revenue, which comprised almost 80% of the total, has grown at a CAGR of about 3%. Additionally, we've seen growth in safety products driven by key activities such as GPO contracting, account conversions, and ongoing service and support. This has offset the revenue decline we've seen in our syringe business, which has followed the decline in insulin vial use as discussed on the previous slide. Now let's turn to the next slide and discuss our brand transition. Our new packaging design has started to flow through to customers in the U.S. as well as Canada.
developed this design with insights from patients and healthcare providers, ensuring we could elevate the Embecta brand and modernize the packaging while maintaining a high level of familiarity with what they know and use today. The color scheme and placement of the needle size is the same. We refreshed the visuals, as you can now see a more realistically sized image of the product, which our patients were very excited about. We've also removed the BD name and logo. Now you just have the product name, Nano 2nd Gen in this particular circumstance, and of course, the Embecta logo. All of these changes are validated by extensive research with patients, prescribers, and pharmacists. These key stakeholders have reacted positively to the update and stated that they will continue using our products following the packaging transition. Turning to the next slide.
While we're excited for people with diabetes to be able to see what the new packaging looks like, the most important thing is to ensure that there's no confusion when our consumers see the changes. We want to reassure them that the product itself is exactly the same today as it was previously. Here you can see that we have a new look, same product stamp on select Embecta-labeled products with the intent to give people with diabetes confidence and support a seamless transition. Additionally, we have carried out an extensive communications campaign across all key stakeholders to ensure there is awareness and understanding for the transition. On the next slide, as I said earlier, the launch is underway, and the new packaging is starting to reach customers.
The first product to transition was our alcohol swabs, which launched in the Q2 of our fiscal year 2025, while the new packaging for the Pen Needles and insulin syringes began to roll out earlier this quarter. We are well underway through the transition in the U.S. and Canada, and the majority of this transition is expected to be completed by the end of this fiscal year. To summarize, U.S. revenue has remained stable, with growth in Pen Needles and safety products offsetting declines in syringes. We maintain strong relationships with key stakeholders through impactful engagement. Our products are widely available across all key channels, supported by world-class manufacturing and distribution. The majority of the U.S. business is through the retail channel, where we have a long history of partnerships.
We contract with payers with the goal of ensuring that people with diabetes have affordable access to all of our products. We are actively pursuing growth opportunities through distribution agreements and commercial partnerships. Before I turn it over to Slobodan Radumilo to walk you through the international business and strategy, let's take a 10-minute break. Thank you.
I never thought your eyes would wander back to me. I told myself I couldn't have you. Ain't it funny how life wakes you to your dreams? Tell me everything you love about me. Find yourself a reason to let go. All the trouble piling up around me. Watch as you tear her as you lighten up the load. I found you in the fire. We never made it out of the house. I found you in the fire. Nobody's ever gonna put us out. There's time to figure out the details.
Time to get around to all the questions on your mind. Take stock of every little worry. We are more than our families, and we are not falling behind. I do not have much education. Not many dollars, not a home to call my own. I cannot appreciate your hesitation. One step at a time, we are gonna be fine and never alone. I found you in the fire. We never made it out of the house. I found you in the fire. Nobody is ever gonna put us out. I found you in the fire. We never made it out of the house. I found you in the fire. Nobody is ever gonna put us out. Honey, I am lost without you there. Cannot count the cost without you there. Cannot bear the cross without you there. I found you in the fire. We never made it out of the house.
I found you in the fire. We never made it out of the house. I found you in the fire. Nobody's ever gonna put us out. Don't kill my bugs. Don't kill my vibe. Just because you never tried. Don't ruin my fun. Don't ruin my time. Just because you've never tried. Summer chill got me feeling like a million-dollar bid right now. Time to kill. I'll be up on the hill with a funny cigarette and a smile. Take it slow. Nowhere to go. 'Cause I'm happy where I'm at right now. Let me know. Or let it go. No time to sit around. Talk about it now. Don't kill my bugs. Don't kill my high. Just because you've never tried. Don't ruin my fun. Don't ruin my time. Just because you've never tried.
Everybody's got a reason to be happy, but not everybody knows how. Anybody gonna find somebody to blame for how it all goes down? Take it slow. Nowhere to go. 'Cause I'm happy where I'm at right now. Let me know. Or let it go. No time to sit around and talk about it now. Don't kill my bugs. Don't kill my high. Just because you never tried. Don't ruin my fun. Don't ruin my time. Just because you've never tried. Don't kill my bugs. Don't kill my high. Just because you never tried. Don't ruin my fun. Don't ruin my time. Just because you've never tried. Don't kill my bugs. Don't kill my vibe. Just because you've never tried. Don't ruin my fun. Don't ruin my time. Just because you never tried. From the moment we met, you could see that I was filled with desire.
Hardly one thing in common, baby, but our love is pure and fire. As sure as the birds on a scene, I wouldn't let you change one thing. Be yourself. Try to have a good time. Be yourself. Try to have a high, high, high, high, yeah. High, high, high, high, yeah. High, high, high, high, yeah. High, high, high, high, yeah. Ain't always fun and games, but baby, baby, I get that feeling. As my name moves across your lips, you see a grown man reeling. You know the way that you act with such tact has got me reaching for the ceiling. You're the one to whom I always turn when I'm having trouble dealing. I wanted you like the Dev Kurdikaril wants a drink. I wanted you in a hunk, can't you see? Be yourself. Try to have a good time. Be yourself.
Try to have a good time. Be yourself. High, high, high, high, yeah. High, high, high, high, yeah. High, high, high, high, yeah. High, high, high, high, yeah. High, high, high, high, yeah. High, high, high, high, yeah, yeah. I need you, I need you, I need you, and there's nothing you can do about it. Spending many nights away, lots of days to get on stage and shout about it. Maybe a rambling man, but I can't, can't be your one if you allow it. You're a mystery so deep, our comedies wouldn't think to try and figure out it. I'm eating you like bacon eats eggs. I'm eating you and there's nothing more to say. So be yourself. Try to have a good time. Be yourself. Try to have a good time. Be yourself. Try to have a high, high, high, high, yeah.
High, high, yeah.
Please be seated. We'll resume in a minute.
Hello to everyone. I'm Slobodan Radumilo , Senior Vice President and President International. I'm excited to share an overview of Embecta's international business and strategy, focusing on some key markets as well as future growth opportunities. Let's turn to the next slide and get started. As we look beyond the U.S., Embecta is well positioned globally with a strong presence across key international markets. This global footprint gives us the ability to serve developed and emerging markets, which is especially important given the rising prevalence of diabetes worldwide. Starting with LATAM and Canada, we have a meaningful presence with offices in major cities. Our sales teams are active across six countries in this region, supported by various distribution centers. Moving to EMEA, our presence spans across Europe, the Middle East, and Africa.
We operate offices in key hubs, and our sales force is present in 17 countries in this region, supported by a major distribution center in the Netherlands, an important logistical advantage as we serve diverse markets with varying healthcare infrastructures. In Asia and China, we have a wide network extending from Tokyo and Seoul to Jakarta and Sydney. Offices in key metropolitan areas like Beijing, New Delhi, and Singapore give us local insights and access. We support operations through regional distribution centers in Japan, Korea, Singapore, India, and Australia, allowing us to respond quickly to regional demand. This robust infrastructure not only provides substantial supply chain reliability, but also supports our ability to scale, adapt to local needs, and maintain customers relationships globally. Our international presence is a core part of Embecta's long-term growth strategy. Let's turn to the next slide and explore developed markets.
We'll be reviewing developed markets, starting with Germany. Next slide. Germany represents a highly structured prescription-driven market, making it essential to build trust with healthcare providers who initiate and manage insulin therapy. Embecta is well positioned here, supported by a strong sales force and products that are well recognized by key stakeholders, including physicians, nurses, and sick funds. We operate through a network of eight wholesalers, which help with widespread product availability and efficient delivery. Our commercial model focuses heavily on supporting physicians who prescribe and nurses who often influence product choice through training and support. Importantly, we engage people with diabetes directly to reinforce education and adherence. Our experienced sales force is focused on the point of therapy initiation, with the goal of making Embecta top of mind when patients begin their insulin journey.
We believe this, combined with our strong product brand recognition and robust distribution footprint, gives us a competitive edge. Let's turn to the next slide. France is a large pharmacy-led market where the influence of the retail pharmacies plays a pivotal role in the product dispensed, and our brand is well positioned to benefit from that dynamic. Our go-to-market model is rooted in a robust, well-established channel strategy. About 40% of our sales come through direct distribution, around 30% through wholesalers, and about 30% via buying groups. This hybrid model provides extensive reach and local relevance. From there, product flows through independent pharmacies who play a crucial role in dispensing and ultimately reach the people with diabetes. On the prescriber side, we maintain strong engagement with both hospital and private endocrinologists, as well as general practitioners and private nurses.
Our commercial teams focus on each of these stakeholders with the goal of having continued awareness and preference for our products. Critically, Embecta benefits from strong brand awareness, a seasoned sales force that supports pharmacies at the point of dispensing, and a deeply established distribution network. These advantages not only support our current leadership in the category, but we believe also create a strong foundation for future expansion into adjacent areas and partnerships through new distribution agreements. Overall, France remains a key strategic market for Embecta, where we believe our trusted brand, local relationships, and tailored commercial model provide a foundation to distribute additional products through the pharmacy. Turning to the next slide. Japan is very much a prescription-driven market, the only one in Asia with many of the same dynamics that we shared earlier for Germany.
Our sales team there is very experienced at engaging with clinicians at the point of therapy initiation, be it in hospital or private clinics and GP practices, and we have a strong network of 58 distributors under management that serve retail pharmacies across Japan. We utilize an omnichannel approach to effectively and proactively scale our reach. Now let's move on to Canada. Canada is a largely reimbursed and retail pharmacy-driven market where Embecta enjoys a well-established position built on decades of strategic partnerships and a focused selling model. This helps us maintain trust and recognition across customers segments with a sales team focused on optimal supply to grow the market, patient education, and key stakeholder engagement. Our strong retail and wholesale relationships support widespread product availability and allow for innovative initiatives across the channel, driving the importance of properly injecting medication and the benefits of an Embecta pen needle.
We also have high penetration of Safety Pen Needle within long-term and acute care channels. Our strength here is reflected in a high share as well as group purchasing organization contracts that help provide long-term stability for continued expansion. Additionally, starting potentially as early as 2026, Canada is anticipated to be one of the first markets with generic semaglutide, representing an exciting new B2B opportunity for our pen needle business. Now let's go to the next slide and look at emerging markets. Emerging markets represent the vast majority of the not on insulin and undiagnosed populations. This creates a tremendous opportunity as more people are diagnosed and subsequently brought up to the standard of care, going through the treatment progression that Ginny Blocki outlined earlier. Now let's move to the next slide and look at a couple of the emerging markets themselves. China represents one of the largest diabetes markets globally.
With a significant local manufacturing and commercial footprint, we believe we are well positioned to continue to grow here. There are about 148 million people living with diabetes in China, including more than 73 million that remain undiagnosed. Prevalence of type 1 diabetes is significantly lower than in the Western world, with approximately 95% of people living with diabetes being type 2. As healthcare in China improves and the rates of diagnosis rise, we expect to continue to see more people living with diabetes access insulin, supporting our growth. Our go-to-market strategy is tailored to the unique structure of the Chinese healthcare system, with insulin therapy initiations occurring in hospitals where our commercial teams are present. Once initiated on the therapy, people living with diabetes are able to access our products through hospital pharmacy, retail pharmacy, or through the e-commerce.
Embecta is listed in over 4,500 hospitals and has access to more than 40,000 retail pharmacies. This expansive reach is supported by three national distributors and a dedicated sales force focused on targeted education, training, and support. Importantly, we have a local manufacturing plant in China, which provides us with faster time to market, reliability, and consistency of our supply, and the flexibility in appropriately adapting to local regulatory and healthcare system needs. Our strong legacy, combined with broad access and deep relationships, continues to drive Embecta relevance in China. Looking ahead, we see significant growth potential through continued expansion into adjacent segments and distribution partnerships, solidifying our role in improving access to diabetes care across these critical markets. We have been finding ways to bring additional value customers in this market by offering adjacent products to support people with diabetes, such as an insulin pump.
More on this later. Moving to the next slide. Mexico is also a large emerging market with a significant number of people that are diagnosed but not yet on insulin, as well as a large undiagnosed population. Similar to China, Mexico is predominantly a type 2 market. However, in Mexico, insulin is delivered primarily in vials, making it an important syringe market for us. We have a trusted and broadly recognized product brand with all key stakeholders, including hospitals and private clinics, the retail channel, and the business-to-business sector, which is primarily pharmaceutical companies that are providing our products, such as Pen Needles, syringes, or alcohol swabs, in patient starter kits. Our omnichannel presence and well-managed network of channel partners puts us in more than 40,000 drugstores today, and we benefit from our local repackaging capabilities that enable us to offer smaller pack, low-cost solutions for predominantly out-of-pocket consumers.
Let's move to the next slide and summarize our international business. We believe our presence in international regions gives us a competitive advantage and puts us straight into the epicenter of future expansion of diabetes and associated therapies, insulin included. We have an incredibly strong sales force and infrastructure in every key region and the ability to get our products where they are needed, when they are needed, and in the configurations they are needed. We believe we have the opportunity and the momentum of expansion through adjacencies and distributor partnerships to provide more value to customers while increasing our custom share of wallet and accelerating our growth. With that, let me now turn it over to Shaun Curtis to take you through our manufacturing and supply chain overview.
Good morning, everyone. I am Shaun Curtis , Senior Vice President of Manufacturing, Supply Chain, and Quality.
Today, I'm looking forward to providing you with an overview of our manufacturing and supply chain capabilities. Let's turn to the next slide and begin. Just quickly summarizing and grounding everyone here, Embecta is a leading manufacturer of devices used in the treatment of diabetes with a long track record of quality and reliability. Our global manufacturing footprint includes three plants, which we'll look at in more detail in a few minutes, with 24/7 operations and more than 1,000 employees who produce over 8 billion units a year. Our capabilities are transferable and allow for the opportunity to expand into other medical supplies. Let's turn to the next slide and talk about how we ensure a resilient and uninterrupted supply. Our supplier management system is built on a foundation of strong partnerships and risk mitigation.
We have long-standing, stable relationships with suppliers for our key raw materials, which include resins, cannula, packaging, and rubber, supporting our continued goal of ensuring these materials are available to our plants when they require them. These partnerships span decades and have helped us successfully navigate multiple challenges from hurricanes to the pandemic and the recent geopolitical challenges. We proactively manage our stocks of raw materials and finished products to address any potential disruptions. customers know that they can count on us to get product where they need it when they want it. Moving to the next slide, let's discuss the single largest category of raw material spend. As we look at the foundation of Embecta's supply chain, the cannula stands out as one of the critical raw materials, making it essential to secure both stability and flexibility.
At Spin, we put in place a long-term strategic supply agreement with BD that reflects this importance. The contract term guarantees our supply for a minimum of 10 years from Spin, providing us with long-range security of supply. It also includes a three-year ramp-down period, offering flexibility as we plan for any potential future transitions or supplier diversification. Excuse me. From a capacity stand-point, this agreement gives us ample volume to meet current requirements. This ensures that we can support current demand and respond to future growth across global markets without disruption. One of the key strengths of this agreement is the monthly rolling forecast model, which allows for efficiency, flexibility, and the responsiveness to our custom needs. Furthermore, our pricing terms are designed to be sustainable and transparent.
We have an established annual cost process with the supplier to account for inflation and any volume impacts, helping us manage spend to predictability while maintaining a strong partnership. As a good business continuity practice, we are currently exploring alternate suppliers. Turning to the next slide, let's look at our three manufacturing facilities. Dev Kurdikar touched on these during his introduction, but I want to again highlight our three world-class manufacturing facilities because this is where our expertise in high volume, plastic molding, automated assembly comes from. The capabilities of these plants and our highly experienced team members are why we believe we are well positioned to expand into the manufacturing of other medical supplies. Our Dunleary, Ireland plant is notable for being the world's largest manufacturer of Pen Needles Safety Pen Needles. it features roughly 270,000 sq ft of floor space, giving us the opportunity to add additional product lines.
The site has been in operation since 1969 and today employs roughly 430 team members. In Suzhou, China, the plant has a floor space of roughly 240,000 sq ft. As with the plant in Dunleary, we have the space to add in additional products. The site opened in 2015 and currently employs about 120 team members. Our facility in Holdridge, Nebraska, is the world's largest manufacturer of insulin syringes. Its floor space is roughly 278,000 sq ft, with room to expand to add additional products. It was founded in 1966. We have about 450 team members on site. As we turn to the next slide, we'll look more closely at the production capabilities in these plants. As I said, we have significant expertise and high-volume production capabilities across our manufacturing network that we believe can be leveraged for other medical products.
Our range of manufacturing capabilities enables the production of over 8 billion units per year. As you can see on this slide, these capabilities include injection automated assembly, high-speed packaging, and, critical for devices, Cobalt 60 sterilization. We have assembly and packaging processes, which include various types of welding, bonding, forming, dispensing, and coating. We have decades of experience handling materials, including resins, adhesives, rubber components, lubricants, solvents, and more. This is backed up by a quality system that has given customers confidence and built our long-standing reputation for high-quality products. This is all managed by a highly skilled, continuous improvement-focused, stable workforce. On to the next slide. Producing over 8 billion units is one part of the equation. Getting them to approximately 30 million people who use them in more than 100 countries around the world is another.
We have built a best-in-class distribution network at Embecta, establishing partnerships with blue-chip logistic providers. With three manufacturing sites and 16 distribution centers, we have been able to navigate through multiple transportation, geopolitical, and trade disruptions. That's another reason customers know they can count on us, which has been reinforced by our performance through the major supply chain disruptions over the past several years. Moving on to the next slide to summarize. At Embecta, we view our manufacturing and supply chain capabilities as the core strategic advantage, built on over decades of global experience and continuously refined to support scalability, reliability, and quality. As the largest producer of insulin injection delivery products around the globe, with a manufacturing infrastructure that has been established for over 100 years, we have significant experience and unmatched capability that we believe can be used to expand into other medical supplies.
We have a world-class safety performance and a reputation that stands from our proven and integrated quality inspection and testing processes. Over the years, we have established a resilient supplier network that enables us to have access to key materials we need to manufacture a high volume of products. We have long-standing relationships with our key suppliers and robust contracts in place for key materials. We leverage localization and right-sized inventory to help protect supply. Finally, we have significantly high-volume end-to-end capabilities, vertically integrated production from raw material through sterilization, and 16 distribution centers that enable us to customers in more than 100 countries in a timely, efficient, and effective manner. This is all possible because of our highly skilled, experienced, stable, and dedicated workforce, which I am so proud to lead. That is the last slide for my section.
We have a 20-minute Q&A session now before we take a 10-minute break. We can open the floor for questions. Pravesh Khandelwal will moderate. Thank you.
Thank you, Shaun Curtis. If you're here with us in the room and would like to ask a question during any of the Q&A sessions, please just raise your hand, and one of our team members will bring a microphone over to you. For those joining via the webcast, you can submit your questions through a Q&A feature on the webcast platform, and we will answer as many questions as possible before taking a break. Please limit your questions to the preceding sections we've gone through right now. We'll open this for questions now.
Hey, guys. Kallum Titchmarsh with Morgan Stanley. Appreciate the color, Jinny, on the differentiated features of the products.
I'm wondering if you could give us any color on how market shares trended across key product lines and whether you think there's any risk, perhaps, from the rebranding of some loss there. And then I have one follow-up, if that's okay.
Sure. So in regards to the market share, Dev Kurdikar had alluded to the fact on one of the slides that our pen needle share is about 50% around the globe, and then our syringe is about 40%, and safety products around 60% share. That has remained relatively stable. As far as the brand transition, the team has done a lot to ensure that that will go smoothly and don't anticipate any challenges with that.
Great.
Maybe you can add to that as well because brand transition is underway in the U.S. and Canada.
Maybe you can comment a little bit about the work that you and the team are doing to ensure that people who use our products are not confused when they go pick up our products.
Absolutely.
Thank you, Dev Kurdikar. Again, as Dev Kurdikar mentioned, as I shared in my prepared remarks, in the U.S. and Canada, we started brand transition officially a few months ago, but we've been working on it for a couple of years. It's been a large cross-functional team looking at this. This is a big deal for us, but this is not a very big deal for a lot of customers. We've had an opportunity to just ensure who we sell to does this very smoothly. One of the unique things in the U.S., the drug compendia provides a direct link from one SKU to the next.
Since we are generally an adjudicated product, once we hit the retail pharmacy, that linkage happens, and we expect a full and seamless transition of our products.
Got it. Just on price, curious how important price taking has been for the business across the past few years, across each product line, and whether you feel comfortable that that is something you can continue to take in the years ahead.
When Jake Elguicze comes up, we'll be discussing sort of our price assumptions. If you do not mind, let's hold that question till the next Q&A, but we'll certainly discuss it.
Anthony Petron from Azulo. Two questions. One, I'm going to start with international penetration. You gave some good color on Germany, France, China, Mexico, obviously U.S. more heavily penetrated.
Looking across those territories, maybe into the LRP, I know we're going to get into more details, but where do you see penetration in those four markets? I have a follow-up on U.S. penetration trending over the next three years in those four markets, then follow-up on U.S..
Yeah. If you look at developed part of the markets, right, they're attractive marketplaces for new technologies, GLP-1, pumps, and their penetration has been present for about a decade or more. So far, despite all of these dynamics, we see certain positive trends for us that we believe will not have major changes in the trends. If you look at the emerging part of the world, right, we talked about the incidence and the prevalence, increasing number of diabetics.
You're talking four or five times larger pool of population that's growing about 2.5x faster than developed markets. We believe that as more people, urbanization, more people have access, more diagnosis, we observe those trends, and we believe that these trends development will sustain. We would not see deviation to what we've observed historically within the long-range plan.
That's helpful. On the U.S. side, the products have broad coverage. From a payer stand-point, you have 96% covered lives, and the retail pharmacy penetration is quite high, right? If you look at that distribution chain, when you start from payers to retail pharmacies and now PBMs, there are various pressures along that distribution chain, and we have an administration that's on an austerity footing.
Just as you look at the U.S. distribution chain, considering pressures at the payer level, retail pharmacy, which we spoke about on the earnings call, just talk about how the U.S. distribution chain is shifting the past 12 months, what you expect in the forward 12 months, and do you envision any price pressures that develop over this time for your products and/or shelf space at the pharmacy level? Thanks.
Yeah. Anthony, with respect to sort of forward-looking, what we've included in the LRP, again, I'm going to respectfully wait until we get to the next Q&A, but we'll certainly, Jake Elguicze is certainly going to go through that in some detail in this section. With respect to sort of how our products flow, Tom Blount, and the interplay between how we work with retailers, payers, and distributors, maybe you can talk a little bit about that.
Sure, absolutely. In the U.S., to remind everyone, we sell directly to drug wholesalers, to medical distributors. We do not sell to payers, right? We negotiate with payers for good reimbursement. Really, with the singular focus of ensuring our patients have the lowest possible out-of-pocket, because especially a type 2 patient, when they go to the pharmacy, they have a massive burden of all types of different products that they take in addition to insulin . [Crosstalk]. As far as how we've historically managed this, we absolutely have strong relationships with all these key stakeholders. Price is only a component, and pressure like that is only a component of how we go to market. The story that you've heard so far from the team is very important.
Reliability of supply through all of these variety of things, how we go to market, the fact that we partner with the retailer as well as the payer matters. The fact that we focus on education in a somewhat forgotten category matters. That is how we show up at the pharmacy, and we do not see that changing in the future.
It has led to this interplay between our relationships with distributors, payers, and retailers. I think it provides us, and the way we go to market with each of them provides us, a differentiated advantage in the marketplace and helps us with the stability that you saw in Tom Blount's section in our revenue over the last several years, almost independent of what else has happened in the marketplace over that time.
Relating to what you were just talking about, have the pressure points moved on the line?
Yeah, just so people on webcast can follow alon g as well. Pleasure. Thanks.
With regards to what you're saying, have the pressure points changed just given the pump market and all the other components that are out there? Have those conversations changed over the years, or have you seen anything unique that you think you could take advantage of?
Sure. Maybe I'll speak to just what our historical has been, and I'll wait for anything forward-looking for when Jake Elguicze goes. What I'll say generally, and Slobodan Radumilo alluded to this a minute ago, the U.S. is a pretty penetrated market. It's developed market when it comes to things like weekly GLP-1s and pumps. They've been around here for a very long time. Generally, what happens when a new drug category hits the market, it delays the time to insulin, right? Eventually, people get to insulin.
What we're starting to see now is insulin pens are actually starting to grow again. We believe a lot of that dynamic has happened, and we are going to start to see insulin pen growth again. The nuance that you're seeing in the overall U.S. business is that, again, this decline in insulin vials/syringes being offset by what we've already seen historically with the growth in pens, as well as a growth in our safety products.
Hi, good morning. Sam Eiber from BTIG. Thanks for taking the questions. Maybe a question for Tom Blount on the education programs with patients and pharmacies. Are those also being leveraged outside the U.S., like in China, where maybe reusing Pen Needles tends to be more common? And then a follow-up for Dev Kurdikar. Early days of this spin, you talked about maybe leveraging that access for patients through digital programs.
Is that something you're still exploring?
Tom Blount, why don't you kick us off and then Slobodan Radumilo talk about China, and I can talk about sort of our digital approach here in a minute.
Sure. The programs that we use in the U.S., again, we believe they're very important because at the pharmacy, the insulin prescription and the pen needle prescription aren't necessarily linked. One is actually a reminder and programs that we want to run with the pharmacist to ensure that they understand the importance of linking these two to make sure that patients have optimal supply. If we think about based on how much insulin is used in the U.S., the amount of singular injections, the amount of singular injection products that should be in the U.S. is double of what it is today.
We have a lot of focus to really improve the penetration of our products with what you would think is a pretty established category. As far as from a patient perspective, if they do not get education at the physician office about what to use, we believe it is very important for that to happen at the pharmacy. That is getting the initial product. I am sure many of you have gotten refill reminders for whatever else you might be picking up at a major national drug chain. It is that type of thing too, like once you are on therapy, that we want to make sure that you have enough product. Slobodan Radumilo, if you want to talk about it.
Yeah. I think it is a chronic disease, right? You have initiation part, what we call incidence pool, and the prevalence pool.
After 100 years in this sphere, we obviously have a large prevalence pool. Our approach is balanced. One is for the people that are in the prevalence pool, you want to provide the information for the awareness, but really the key is reliability of supply and the quality of the products. You have repetitive coming for refurbishing the prescriptions. Our sales force focuses on initiation phase, right? Because that's the critical phase where you share the key information with people living with diabetes, how to use insulin, how to properly inject. You can only achieve that when you have a local presence in that point of initiation. This is what we have, as you've seen in the slides, and provides us really a strong competitive advantage compared to what we see elsewhere.
With respect to just sort of our digital efforts, I mean, they vary country by country. In China and in other parts of Asia, we have a strong education component because we found that with that education component at the point of initiation, patients can get appropriately counseled on injection techniques. The other thing I would add, we did not cover it today, but I know I have spoken about it in the past, is particularly in Asia, we have a growing e-commerce presence. That is certainly a way we both inform people about our products as well, provide an opportunity for them to acquire products. That works well in cash pay markets because they do not have to go through sort of an adjudication of their product like they do in the U.S.
We have one question submitted via the webcast.
This question is from Marie Thibaut from BTIG. It sounds like the ongoing brand transition is going well in both the U.S. and Canada. Is there a point in time when you will know that everything is de-risked and that the transition was completed smoothly? From a timing perspective, is that point in time one or two quarters away, or is it longer?
Maybe I'll start off by just broadly commenting on brand transition globally. U.S. and Canada this year, most of it largely done by the end of our fiscal year, most of the rest of the world through 2026, and then the residual sort of countries in 2027. Tom Blount, why don't you talk about U.S. and Canada and when you expect to know that the majority is complete and the quality of that completion? Yeah.
Sure. Thanks, Dev Kurdikar. Thanks, Marie, for your question.
In the U.S., we're about halfway done. We've got a lot of our big mover SKUs that have already started in the channel. They have started to work their way through the wholesalers and distributors, and we are waiting to see them on shelf. They've started to trickle onto the shelf. Again, about half of that has gone. We have a few more waves going, with well over 90% of the U.S. and Canada being fully transitioned by the end of the fiscal year.
I'm showing. Sure. Yeah.
Hi, Pam Hansen with Citizens Bank. Just wanted to ask a question of Shaun Curtis since you've been left out here so far. Just as you went through sort of how critical, obviously, the manufacturing is, the quality, the capacity, you've got those three facilities running, I think you said 8 billion units a year.
Is there capacity there to increase? I know there's the talk about going long range to adjacencies. Would there be much entailed in capital expenditures, or is this something you'd look to acquire? And sort of also employment, labor availability. Just wanted to ask you that. Thank you.
Yeah, sure. Thanks for the question. When it comes to the current utilization of our manufacturing plants, we're running approximately 75% utilization of our capacity. That means when Dev Kurdikar and Ginny Blocki goes into some of the opportunities, we are well suited to make that under our current production machinery. On top of that, across our manufacturing sites, we have about almost 100,000 sq ft, 10% of spare footprint, which is under roof footprint.
Again, that's where most of the costs come, the infrastructure, the resin handling, the packaging, the warehousing, and also that skilled workforce because we'd leverage those period costs of those skills. In that effect, the cost will be mainly on what we decide to make and put into those facilities. We know that could be from $5 million-$15 million for each production line. It all depends what we decide to make. To summarize, I would not see the capital to be very extensive because we have everything in place already.
The expertise that's resident within our ops team is very applicable to some of the other medical products that we made. A lot of the disposable medical products are plastic-based, and our team really is world-class at that.
I mean, if I may say, Dev Kurdikar, just to add to that, to make the 8 billion products, we mold approximately 30 billion plastic components a year. Every minute, I think I calculated, if I get this right, about 60,000 sub-assemblies a minute. That is phenomenal. All of that is handled, is then taken to the machines, is made sure it is in the right order, is then assembled, is then packaged, is labeled, sterilized, and we get it out to our 16 distribution centers and then 100 countries, and then, of course, to those 30 million people with diabetes. That takes a lot of skills and a state-of-the-art enterprise resource planning system that we have put in place as part of the spin.
Yeah. Under obviously a quality system that has stood the test of time. Second to none, yeah.
Thank you.
That's the time we had for Q&A. We'll take a short 10-minute break, and we'll be back with Ginny Blocki and Jake Elguicze for the following sections.
In the lazy morning where the salt wind blows outside the crazy this world goes, I can feel the freedom in between my toes where the sand meets with the shore. Drifting through the days without a care in our mind, leaving all our worries and our troubles behind, doing what we please without a reason or rhyme. Thank God for the memories and the summertime, yeah, the summertime. Give me that sweet summer song where the tide is singing along, singing along. The tide is singing along. Drifting through the days without a care in our mind, leaving all our worries and our troubles behind, doing what we please without a reason or rhyme.
Thank God for the memories and the summertime, yeah, the summertime. Leaving all our worries and our troubles behind. Thank God for the memories and the summertime, yeah, the summertime. Do not take it for granted. Love when you have it. You might be looking over a lonely as soldier. Remember when we said they would never have children? I am holding you, baby, now that we are older. How time has revealed how little we know. I have been too busy. I should have known this. Days that keep slipping, a life that I am missing. I wish it were true love. I wish we were kissing. Show me a love that will not ever leave or look for another one to deceive. I am beginning to wonder if anything is real. Guess we are just at the mercy of the reality. Alone with the past, no other can share. Alone with the heart, no other can bear.
Give me some heaven, just for a while. Make me tell. There in your smile. We could have done more with our time. Could have run, could have left this place behind. We let our time run away. I gotta go, but we both know. Oh, we know because it ain't the first time that I gotta leave you behind. No matter where I go, I'll hold you. Gonna hold you in my mind. Gonna hold you in my mind. I won't let go. I'll hold you. Gonna hold you in my mind. Gonna hold you in my mind. If all you know I got to go away, let's tomorrow just for a day. Can you hear me now? What I'm trying to say. Let's tomorrow just for a day. Let's tomorrow for a day. You try to count down the days.
Try to count them down, make them go away. They all keep rolling much the same. It's killing me that I got to go, but I gotta get back on the road 'cause baby, know that I'm a rambling soul. No matter where I go, I'll hold you. Gonna hold you in my mind. Gonna hold you in my mind. I won't let go. I'll hold you. Gonna hold you in my mind. Gonna hold you in my mind. If all you know I got to go away. Let's tomorrow just for a day. Can you hear me now? What I'm trying to say. Let's tomorrow just for a day. If we're both here, we should be both clear on what we hold dear. If we only got today. If we're both here, we should be both clear on what we hold dear.
If we only got today. If all you know I got to go away. Let's tomorrow just for a day. Can you hear me now? What I'm trying to say. Let's tomorrow just for a day. Let's tomorrow for a day. When we first met, girl, you were the one for me. And every single day, making new memories. Talked all day, made love all night. When I held you, baby, it felt so right. Never ever thought this feeling would go away. I want to say to you, baby, don't chase the beat. 'Cause I don't need no flames, baby. It's okay with me 'cause I'm gonna just fine, just fine, just fine. Don't make no more excuses 'cause I know everything's useless now. Don't pray for change. We can be just fine, just fine. Yeah.
Girl, I want to thank you for everything you've done for me. You know I never ever met anybody like you, oh no. We could never bring back the way things used to be. No matter how hard we try, we can't change history. We used to have a long, once-and-half good conversation. Now our difference in opinions is turning into situations. Oh, yeah. Now we know it's not meant to be. Now we both have set each other free. Now that we see all the signs, it's time to leave this thing behind. Don't chase the beat 'cause I don't need no favors from you or nobody. It's okay with me 'cause I'm gonna just fine, just fine, just fine. Don't make no more excuses 'cause I know that the fang is useless, you're heart. Don't pray for me.
We can be just fine, just fine. Oh, all right. Don't chase the beat. Oh, I don't need no favor, baby. It's okay with me 'cause I'm gonna just fine, just fine, just fine. Don't make no more excuses 'cause I know that thing is useless, your heart. Don't pray for me. We can be just fine, just fine. Don't chase the beat. Oh, I don't need no favors from you or nobody. It's okay with me 'cause I'm gonna just fine.
Now I'd like to welcome Dev Kurdikar and Ginny Blocki back to the podium to talk about the value creation opportunities that we see for Embecta in both the near-term and long-term period. Dev Kurdikar.
Thank you, Pravesh Khandelwal. Next slide. I spoke earlier about how we are seeding growth, which will lead to Embecta's overall transformation.
In this section, we want to lay out our path to value creation. We'll outline our plans in the near-term, that's in the next one to three years. Mid-term, that's three to five years. Longer-term, which would be beyond five years. We have made significant progress since spinning off as an independent company in April 2022, with most of the stand-up work behind us. 2025 marks a strategic shift from being an insulin delivery company to aspiring to become a broader-based medical supplies company. There are several objectives that we plan to accomplish over the next few years to sow the seeds of growth and that are intended to move us toward our goal. As we get beyond the LRP period, the fruits of our efforts should come into focus.
By that time, we expect we will be well on our way to becoming a broad-based medical supplies company that serves chronic care patients and drug delivery partners. As we move to the next slide, I will walk you through how we are intending for that shift to occur. There are a few areas that we are focusing on. The first lever we can pull is to bolster our existing foundation. That means focusing on country-specific opportunities and adding in new market-specific Pen Needles and syringes in relevant geographies. When we spun the business in April of 2022, we had a footprint that was built for a large company with multiple business units. We are now ready to evaluate our presence and go-to-market strategies in countries that contribute a minor portion of our revenue, but potentially disproportionately add to complexity and infrastructure costs.
These are all very actionable for us and are expected to happen over the near to mid-term. Secondly, we are looking at ways to better leverage our commercial footprint itself, including our sales network, retail relationships, and distribution channels to distribute more products that customers need. This, again, is something we believe is actionable in the near-term. The value of this will be determined by the distribution partnerships we enter into. Another lever to drive upside is through GLP-1 opportunities, which could be the single biggest organic growth opportunity for the company. As you probably know, GLP-1s are often administered through a pen injector. For that, you need Pen Needles. As we've seen, Embecta is the world's largest manufacturer of Pen Needles. We are well positioned to be competitive in supplying this pen needle demand.
Additionally, our Pen Needles are fully compatible with currently marketed pen injectors for GLP-1 therapies. We believe our current production capacity can serve the forecasted demand without any significant capital investment. Thus, all incremental volume would have a high margin drop-through. We estimate this opportunity could be worth $100 million or more longer-term. Finally, we want to leverage our manufacturing capabilities and competencies to broaden and diversify our portfolio. We discussed earlier our significant expertise in high-volume plastic injection automated assembly, plus so much more. We believe that there is an opportunity for us to leverage that expertise for products we can make and sell ourselves or as a contract manufacturer. Overall, we believe the markets we are evaluating would provide us with attractive growth opportunities. Let's move to the next slide, and Ginny Blocki will talk about each of these items in a bit more detail. Ginny Blocki.
As Dev Kurdikar mentioned, the first lever we can pull is to look at our existing foundation for opportunities to inject organic growth into the company. Our regional teams have identified additional market opportunities, including the examples listed on this page, such as tender opportunities for business we currently do not have, opportunities to gain customers and people with diabetes in the retail setting, long-term and acute care settings. We are also looking at how to serve new customers segments, expand hospital opportunities, and enter into supply agreements through localization efforts. Lastly, we are exploring additional private label opportunities for our injection portfolios. These are just some of the examples that our commercial teams have identified and are pursuing that can help Embecta solidify our current business. Let's turn to the next slide, and we'll discuss what we mean when we talk about market-appropriate Pen Needles and syringes.
We recognize there are certain countries and segments that are looking for market-appropriate products. This means products that are designed to meet local market needs. We believe developing such products will unlock value in market segments where we have not previously participated. If you look at the right side of this slide, you'll see what I'm talking about. There is a significant addressable market for conventional insulin syringes and Pen Needles in segments where we currently have less than 5% share. For insulin syringes, we believe the addressable market for LATAM, Asia, and EMEA totals about 1.2 billion units. For Pen Needles, the addressable market in these regions is approximately 1.5 billion units. We expect to launch these market-appropriate products in the near to mid-term with a strong go-to-market strategy that stems from our long experience selling insulin devices over the last 100-plus years.
These, of course, will be high-quality products in keeping with Embecta's brand and reputation, but designed very specifically for these markets and their needs. Turning to the next slide. Throughout this presentation, we've been talking about seven key markets: the U.S., China, Canada, Germany, France, Japan, and Mexico, which account for greater than 80% of our fiscal year 2024 revenue. The remainder of our revenue comes from what we refer to as a long tail of about 100 countries. We have begun assessing these markets in phases to understand the best approach and opportunities. For example, do we change the go-to-market strategy, such as via a master distributor, or do we exit some markets completely? The determination may enhance our revenue growth rate and increase our margins by reducing our infrastructure costs. This is a near-to-mid-term initiative, with the goal being to optimize where we play and how we win.
Let's turn to the next slide and talk about our commercial capabilities. Thanks to our strong and well-established commercial capabilities, we have been able to partner with multiple different companies. We have highlighted a few examples on this slide to provide you with an understanding of how we've accomplished this. On the left, you'll see that we are the exclusive distributor for a second-generation insulin pump, which has been specifically designed for the market it serves. This pump is being represented to the customers that we call on currently, leveraging the same channel and the same sales force. Similarly, we are distributing a protective patch offering that is used to cover continuous glucose monitor sensors. Again, this is the customers, same channel, using our same sales force.
On the right- side of the screen, you will see a blood glucose monitor, or a BGM, which is a cost-effective product offering for markets that still have a significant need in the BGM space, which is typically in the emerging markets. In this case, the product goes to the customers through the same channel and uses the same sales force as our other products. While the overall market for BGMs may decline over time, we expect that any initiative we pursue in this space would be accretive to our bottom line. We will continue to pursue partnerships and distribution arrangements that make sense where we can leverage our established commercial channel and our sales force. Let's move to the next slide. We believe we have an opportunity to expand our pen needle business alongside the expansion of GLP-1 therapies.
As mentioned earlier, GLP-1 therapy often comes in pen injectors. If it comes in a pen injector, the patient will need a pen needle to deliver it, similar to insulin. This slide illustrates projected pen needle and market demand tied to weekly GLP-1 therapies. develop this view, we modeled the overall GLP-1 market using a combination of external analyst forecasts, market research, market data, market trends, and internal analysis. This allowed us to segment the market into therapies that are co-packaged with Pen Needles and those that are not co-packaged with Pen Needles, oral formulations, and products expected to go generic over time. Once modeled, we were able to estimate the portion of the market that would require Pen Needles, specifically distinguishing between branded co-packaged and branded non-co-packaged therapies.
We also anticipate the emergence of generic co-packaged products potentially as early as 2026 in select markets, with broader generic availability expected in the years that follow, particularly after 2031 and 2032, as key patents expire developed markets. With that in mind, the addressable market for Embecta breaks down as follows. First in gray are the generics. These are expected to enter the market as patents on branded GLP-1 therapies expire. Many of these should be co-packaged with Pen Needles, creating a natural fit for our offering. Next, in light blue are branded GLP-1 therapies that are not co-packaged. Since these therapies are delivered via pen injectors, they represent an opportunity for Embecta Pen Needles to be utilized. Finally, in dark blue are branded therapies that are already co-packaged with Pen Needles.
This segment is largely self-contained and therefore not expected to be a near-term source of demand for our products. Taken together, these segments represent a significant long-term opportunity for Embecta, with the total potential pen needle demand anticipated to be worth $100 million or more by 2033. Breaking this down a bit further, currently, Embecta is working with more than 20 pharmaceutical manufacturers to include Embecta Pen Needles with their GLP-1 therapy. We have signed or are in the process of finalizing agreements with several pharmaceutical partners. Currently, Embecta Pen Needles are included in multiple regulatory filings, and discussions are underway with pharmaceutical manufacturers for launch starting in select markets potentially as early as 2026 to understand their forecasts. As I pointed out before, the most meaningful and material opportunity is when these generic drug companies launch generic versions of GLP-1s developed markets.
Now, related to the branded GLP-1 pen injectors requiring pen needle retail packs, it does depend on the country and the local market dynamics. Some markets are looking for a specific pack size; others are not. Based on the market feedback and weekly GLP-1 therapy availability, Embecta continues to launch tailored retail small-count packs to meet the needs of patients that are on GLP-1 therapy. As mentioned, this is a significant opportunity for our Pen Needles. Both the pharmaceutical partnerships and the retail opportunity could drive more than $100 million in revenue by 2033. Keeping the LRP period in mind, we have built-in expected revenue contributions from GLP-1s starting in fiscal year 2025 to fiscal year 2028, with the most meaningful contributions occurring post the LRP period. Now, let's discuss how we could leverage our manufacturing and commercial strengths on the next slide.
As Dev Kurdikar mentioned and you heard from Shaun Curtis, based on our manufacturing capabilities, significant expertise in high-volume plastic injection molding automated assembly, and many more manufacturing capabilities, we believe that there is an opportunity for us to leverage this expertise to make products that Embecta can sell or that another company can sell. We believe this will help Embecta to broaden and diversify our product portfolio. For products we make, we are looking to see how we can leverage our channel expertise, for example, in the retail channel to sell prescription or over-the-counter products, or expand our partnerships with distributors and wholesalers that we have strong relationships with. Lastly, we are looking at synergies with people with diabetes and the patients we serve, patients that manage chronic diseases at home. Next slide.
Dev Kurdikar laid out our goal to transform Embecta into a broad medical supplies provider and drug delivery partner that focuses on chronic care patients and therapies by leveraging our manufacturing and channel strengths. To do that, we identified our manufacturing strengths and competencies and then evaluated the world of med tech to identify product categories that are synergistic with these competencies. Ultimately, creating a short list of products and areas that we believe are attractive for Embecta and can more than double our total addressable market and would be accretive to our growth profile. On the next slide, we'll look a little bit deeper into the product categories. We have assessed a significant number of product categories and segments and narrowed it down to drug delivery, chronic care, continence care, and select med surge consumables.
These categories are where we believe we can leverage our capabilities in high-volume plastic injection molding, long-standing history of reliability and high-quality products, channel access, and significant synergies with other products or programs. Going a bit deeper, we'll turn to the next slide. We intend to initially focus on the drug delivery and chronic care product areas. These two categories and product areas of focus would more than double the Embecta TAM. In 2028 and beyond, we will look to continue to expand our portfolio based on products that we will bring to market organically through M&A or via partnerships. We will seek to expand our B2B pharmaceutical partnerships with additional opportunities and drug delivery capabilities. Ultimately, these steps would transform Embecta into a broad-based medical supplies company that serves chronic care patients and drug delivery partners while driving strong strategic growth.
I'll turn it back to Dev Kurdikar to walk through how all of these items tie to Embecta's transformation. Dev Kurdikar?
Thank you, Ginny Blocki. We covered a lot of ground in this section, but the most important thing that I want you to take away is this. We intend, over time, to transition the company into a broader medical supplies company, using our current competencies as a foundation upon which to build. We are working to bolster our foundation and expand the use of our products for GLP-1 delivery. Beyond that, we want to add products to our portfolio that can help transition the company to growth. As you will hear in the next section, this transition may be potentially sped up with opportunistic M&A once our net leverage has been brought down. Some of the seeds of this transformation have already been planted.
As we flip to the next slide, we are excited to see our vision for the future come to life. We remain committed to empowering people with diabetes today to live their lives unlimited. That has not changed. We believe our transformation will enable us to reach higher, impacting even more lives and paving the way for a life unlimited for tomorrow. Now, I'd like to invite Jake Elguicze, our Chief Financial Officer, to the podium to discuss our financial overview and long-range plan, which will then be followed by a Q&A before we close today's program. Jake Elguicze?
Good morning. I am Jake Elguicze , Embecta's Chief Financial Officer, and it is a pleasure to be here today at Embecta's first Analyst and Investor Day.
I hope that during the past few hours, you have learned more about our company, including our products and the various markets that we operate in. Additionally, I hope that you have gained some insights into the strategic vision for the company moving forward. Moving to the next slide. During the next several minutes, I will do a review of how we have performed post-spin and how that compared to the financial goals and objectives that we provided pre-spin. Next, I will quickly take you through our fiscal year 2025 financial guidance, which we have reaffirmed today. This will be followed by providing the investment community with our financial goals and objectives through fiscal year 2028. Finally, I will close with a summary and some key investment highlights. Next slide. As a reminder, Embecta became a publicly traded company on April 1st, 2022.
Just prior to that occurring in March of 2022, we had provided the investment community with two key financial metrics to judge us by. Those were that we anticipated that our fiscal year 2022 through 2024 constant currency revenue growth compound annual growth rate, or CAGR, would remain relatively flattish, and that our fully burdened Adjusted EBITDA margin would be approximately 30% by 2024. As you heard from Dev Kurdikar earlier today, over the past three years, there has been a tremendous focus on keeping the business stable. I'm pleased to say that despite having to complete very complex separation and stand-up activities in approximately 140 countries, we were able to exceed our adjusted constant currency revenue CAGR as we grew approximately 1.3% from 2022 through 2024.
Additionally, despite operating during a time of unprecedented inflation, which was an incremental headwind of approximately 500 basis points to the Adjusted EBITDA margin targets we set pre-spin, coupled with rising interest rates, foreign exchange headwinds, geopolitical tensions, and supply chain and labor disruptions, I'm also pleased to report that we exceeded the Adjusted EBITDA margin targets we provided pre-spin, ultimately generating an Adjusted EBITDA margin of 31.4% during fiscal year 2024. This was possible due to strong execution from all the Embecta associates around the globe, as positive performance within our pen needle and safety product areas offset expected declines within our U.S.-based syringe product portfolio. Turning to our fiscal year 2025 financial guidance on the next slide. During our Q2 earnings conference call held on May 9th, we provided an update to the investment community concerning our financial expectations for fiscal year 2025.
Today, we are reaffirming all financial targets. This includes an adjusted constant currency revenue guidance range of between -2.5% and -4%, an adjusted gross margin guidance range of between 62.75%-63.75%, an adjusted operating margin guidance range of between 29.75%-30.75%, an adjusted earnings per share guidance range of between $2.70-$2.90, and finally, an Adjusted EBITDA margin guidance range of between 36.25%-37.25%. As a reminder, these margin and adjusted earnings per share guidance ranges include an expected headwind from incremental U.S. and China tariffs of approximately $3 million or 25 basis points. Moving to the long-range plan timeframe on the next slide.
The financial targets from fiscal years 2026 through 2028 that I am about to walk you through reflect the execution of the three key strategic priorities that Dev Kurdikar and the leadership team have highlighted for you today, which includes strengthening the core business, expanding our product portfolio, and increasing our financial flexibility. Beginning with strengthening the core business, this goal is largely focused on successfully completing our brand transition project over the next couple of years, as well as executing on some of the growth opportunities that the team has highlighted today. Globally, we expect to maintain our leadership position within insulin devices. While in terms of expanding our product portfolio, we are focused on areas that we believe would allow us to leverage our global commercial channel, as well as our core competencies in high-volume manufacturing.
This includes development and launch of new market-appropriate pen needle and syringe products, achieving additional revenue within our pen needle products associated with the GLP-1 opportunity that Dev Kurdikar and Ginny Blocki spoke about earlier, as well as generating an increased amount of revenue during the long-range plan timeframe from distributed products. The third strategic priority is centered around increasing our financial flexibility, which includes a continued focus on additional cost optimization and maintaining tight operating expense controls. Lastly, given that our stand-up activities are largely behind us, during the long-range plan timeframe, we no longer anticipate having to use cash to the same extent that we did during fiscal years 2023 through 2025, thereby allowing us to reduce our gross debt by between $450 million and $500 million, and achieving a net leverage ratio of approximately two times by fiscal year 2028. Let's turn to the next slide.
The achievement of these strategic objectives translates into the following financial targets: a flattish constant currency growth CAGR through fiscal year 2028, an adjusted operating margin of between 28% and 30% in fiscal year 2028, an ability to generate approximately $600 million in cumulative free cash flow through fiscal year 2028, which is defined as cash flow from operations, less capital expenditures. Lastly, the ability to repay between $450 million and $500 million in debt while keeping our dividend unchanged, resulting in an expected return of capital to shareholders of approximately $107 million during 2026 through 2028. Altogether, this long-range plan reflects our continued focus on operational discipline, financial consistency, and long-term value creation, even in a flattish revenue environment. As we transition from the long-range plan framework, it's important to outline some of the key assumptions that underpin our outlook for fiscal years 2026 through 2028.
On the left-hand side of the slide, you will see what our outlook assumes. This includes that there will be general stability within the macroeconomic and operating environment, as well as an assumption that costs increase at a rate of approximately 4% over the LRP timeframe. Additionally, we expect to see annual tariffs of approximately $9 million during the long-range plan timeframe. This amount was estimated based on U.S. and China tariffs in effect on the date of our Q2 earnings conference call. We recognize that those tariffs have been temporarily reduced, and we expect to update our tariff estimates as the tariff environment evolves.
While in terms of foreign exchange and interest rates, we have assumed that the FX rates that we used when determining the second half of fiscal year 2025 remain constant during the LRP timeframe, while we have also assumed that the interest rates are aligned with the current Fed dot plot. Turning to some key things that our outlook does not assume. First, our outlook does not assume any change in the diabetes treatment paradigm due to the introduction of new drug therapies. Second, other than U.S. and China tariffs discussed previously, our outlook does not factor in any incremental tariffs that were announced and paused, or any non-tariff trade barriers. Third, during the LRP timeframe, we are not factoring in any customers losses.
Finally, our financial outlook does not assume any contribution from either M&A or additional distribution agreements that have not already been signed as of the date of this event. In short, our long-range plan reflects a disciplined and grounded approach and is rooted in what we can reasonably predict today. Now that we have reviewed the underlying assumptions supporting our long-range plan, I'd like to take a moment to unpack the first pillar in more detail: our expected revenue trajectory through 2028. Next slide, please. As shown on this slide, we expect to maintain a flattish constant currency revenue profile over the fiscal 2025-2028 time period, using the midpoint of fiscal 2025 guidance as our base. This reflects that our core injection and contract manufacturing constant currency revenue CAGR is expected to decline by approximately 1%-2%.
This decline is primarily due to anticipated pricing headwinds developed markets, somewhat offset by low to mid-single-digit growth within emerging markets. Additionally, we are also factoring in modest amounts of additional revenue associated with market-appropriate syringes and Pen Needles that we are in the process developing. While in terms of new revenue streams, we expect that revenue associated with GLP-1 B2B partnerships, as well as distribution agreements that have already been executed, will help offset base business softness and provide revenue stability. Longer- term, as Dev Kurdikar and Ginny Blocki shared earlier, the potential for post-2028 revenue growth acceleration is expected to be primarily driven by additional GLP-1 B2B opportunities, largely correlated to when certain drugs go generic post the LRP period. Based on our internal estimates, these GLP-1 opportunities have the potential to generate over $100 million in revenue by 2033.
Moving to our thoughts on longer-term adjusted operating margin on the next slide. During the LRP timeframe, we expect adjusted operating margins to remain relatively stable as compared to fiscal year 2025 and be in the range of approximately 28%-30% for fiscal year 2028. This assumes that our adjusted gross margins will modestly decline due to the combination of inflation and pricing pressure, as well as the incremental impact of tariffs. We expect these headwinds to be partially offset by cost improvement programs. While in terms of operating expenses, our outlook through 2028 assumes a modest increase in R&D expenses to support key activities such as development of market-appropriate pen needle and syringe products. Additionally, our R&D outlook also includes investments to explore the potential for additional cannula suppliers, the benefits of which fall outside the 2028 LRP timeframe.
Lastly, in terms of operating expenses, we expect SG&A to also remain relatively flat, reflecting inflationary pressures being partially offset by the annualized benefit of the recently announced restructuring program, as well as a reduction in the amortization expense associated with our ERP system. Moving to free cash flow on the next slide. Given the significant amount of cash that Embecta has had to use over the past three years post-spin, first focused on stand-up activities, and most recently focused on the shut-down of our insulin patch pump program, the free cash flow capabilities of the company have been limited, as during fiscal years 2023 through 2025, we expect to generate approximately $196 million of free cash- flow.
As we move forward throughout the LRP timeframe, given the relative stability we expect in terms of revenue and operating profit, coupled with a significant step down in terms of cash used associated with separation activities, as well as improvements in terms of working capital that we will also be focused on, we expect to be able to generate approximately $600 million in free cash flow generation from 2026 through 2028, which would represent an increase of approximately 206% from the prior three-year timeframe. What do we intend to do with all that free cash flow? Let's take a look on the next slide.
Given the significant free cash flow generation which we expect to generate over the next three years, first and foremost, we intend to reduce debt by between $450 million and $500 million, allowing our net leverage levels to reach approximately two times by the end of fiscal 2028. This is very important to us, as it would create a significant amount of balance sheet flexibility moving forward. Another important piece of our capital allocation framework relates to returning capital to shareholders. During the LRP timeframe, we anticipate maintaining our current level of dividend, which would equate to approximately $107 million in dividends. Lastly, given the additional balance sheet flexibility that we would envision beginning in the 2027 and 2028 timeframe, we would look to opportunistically broaden and diversify our product portfolio through M&A.
This balanced capital allocation strategy reflects our commitment to financial discipline, operational excellence, and long-term value creation for our shareholders. With that, let's go to the summary slide next. In closing, I would like to summarize what you have heard today from the management team of Embecta. We operate a resilient, geographically diverse, global business with a stable base and expanding opportunity set. Our strategy is clear and focused. We believe enabling to maintain solid margins, generate strong cash flow, and execute against our priorities, even within a flattish revenue environment. During the LRP timeframe, we are targeting a flattish constant currency revenue CAGR, adjusted operating margins of between 28%-30%, generating approximately $600 million in cumulative free cash flow and a net leverage ratio of approximately two times by the end of fiscal 2028.
Importantly, beyond the horizon of this long-range plan, we see significant long-term value creation potential, particularly from emerging opportunities like GLP-1 B2B partnerships with generic pharmaceutical companies. That completes my prepared remarks. We appreciate your continued support and look forward to delivering on the commitments we have laid out here today. We have a 30-minute Q&A session now for this part of the event before we break for lunch. We can now open up the floor for questions, and Pravesh Khandelwal will moderate.
Thank you, Jake Elguicze. We are open for questions, so please raise your hand in the room if you have a question. Anyone on the webcast, we will be taking your questions after that.
Hey, Kallum Titchmarsh at Morgan Stanley. Curious, Dev Kurdikar, whether there's potential to partner with these generic manufacturers beyond just GLP-1s.
Secondly, is there potential for you to push into the pen injector itself and start manufacturing that rather than just the needle? Thank you.
Yeah, the answer to the first part of your question is yes. What's perhaps not so visible is that over the last year, we have significantly deepened our relationships with generic pharma manufacturers. Obviously, right now, the conversations that Ginny Blocki talked about are about Pen Needles, but certainly now we have a channel to discuss additional opportunities. With respect to your question on pen injectors, obviously, I do not want to foreshadow exactly which products we might get into. As we have discussed in the past, that does appear as a natural adjacency for us. In Ginny Blocki's presentation, you saw her talk about drug delivery as an area that we are interested in, and certainly that would squarely fall into that.
Great.
Jake Elguicze, maybe can you just help us to understand what's being assumed at the top and bottom- end of the revenue guide?
Sure. I mean, I think if you step back, when we provided our two financial targets for through fiscal 2024, new company, new management team, we certainly wanted to provide revenue targets as well as an Adjusted EBITDA margin target through 2024 that we had a very high degree of confidence in our ability to meet. I think we also intended to take that same approach today. I think we feel very, very good about our ability to hit those longer-term financial targets, if not, hopefully, being in a position to do a little bit better.
In terms of the revenue number, it really, in terms of the core business and contract manufacturing guidance ranges of assuming to be down somewhere between 1%-2%, Kallum Titchmarsh, it really comes down to two things. It comes down to our thoughts on U.S. syringe revenue, and it comes down to our thoughts on what happens with contract manufacturing revenue. In terms of the 1% decline, we are essentially assuming that our U.S. business in syringe goes from, let's call it around $35 million or so in 2025 and gets cut in half by 2028. Likewise, in terms of our contract manufacturing business, we generated a little over $9 million in terms of contract manufacturing revenue for the first six months of 2025. If you did nothing more than annualize that, you are somewhere in that kind of like almost $19 million-$20 million type range.
When we're talking about a 1% CAGR decline, that also assumes that our contract manufacturing revenue is cut in half by 2028. That's sort of the 1%. In terms of the 2%, essentially, it assumes that our U.S. syringe revenue goes to zero by 2028. It also assumes that our contract manufacturing revenue goes to zero. That might be a slightly conservative assumption, but I think it's something that, given where the trajectory of the syringe U.S. revenue has sort of gone over the last five + years, we thought that it was prudent to sort of handicap that on the low end. Likewise, just based on the feedback that we've been receiving from BD regarding the contract manufacturing revenue, we thought that it was prudent to also handicap that going to zero.
Again, I think that sort of provides us with a high confidence level in our ability to hit kind of the 1%-2% decline. The pen needle revenue, the safety product revenue, we're assuming that those revenues remain stable throughout the LRP period. If you look back from 2019 through 2024, in aggregate, that 84%-85% of our revenue has sort of grown in the 2%-3% range. Those are sort of the working kind of base case assumptions in terms of revenue. In terms of GLP-1 and sort of new product revenues, first, I think we are factoring in a very, very modest amount of revenue associated with what we're referring to as market-appropriate products.
Those market-appropriate products are going to be, they're not expected to be developed until late 2027 and then would come into the market sometime beginning in kind of 2028. I think just sort of as a frame of reference, I think our working assumption is that maybe in 2028, that represents about 1% only of our total company revenue. A very, very small amount, somewhere around, let's call it $10 million of incremental revenue being generated from sort of these market-appropriate products. We sort of get to kind of the new revenue streams. That's really a combination of GLP-1s, which I think we've taken a relatively prudent approach in terms of what the penetration amounts are there through 2028, coupled with the distribution agreements that we have already signed. That is something where it's not predicated on something new happening.
Those are things that we know are going to happen. We factored in those new distribution agreements. That really relates, again, related to products associated with BGM, with pump in particular in China, with an ultrasound product as well. I think we feel like there's a pretty high degree of confidence in terms of our ability to achieve sort of that, both the slight declines in kind of the core and contract manufacturing business as well as the new revenue contributions that we spoke about today.
If I can just add a couple of points to that, right? The two drivers that Jake Elguicze talked about, contract manufacturing and syringe, contract manufacturing, you've heard us say that before is a very low-margin business for us, like single digits. Syringe is much lower than the other product families.
Given the variability that Jake Elguicze outlined in the revenue, this gives us high confidence that regardless of where we are on that spectrum of outcomes, the $600 million in free cash flow, we feel very highly confident about.
Anthony from Mizuho. Thanks for all the detail and presentation. Maybe one quick follow-up on the LRP, just in terms of the low- to- high range, - 1 to - 2, but tying that to the adjusted operating profit guide, which is 28%-30%. It is down from the 2025 level. And Dev Kurdikar, you mentioned these are dilutive categories, syringe and contract manufacturing. Under a scenario where they go to the lower- end of that range, essentially zero, I would assume that gets you to the high- end of that range in 2028.
Is there a scenario where it actually can bring that above that range and you would necessarily stay flat from a margin stand-point? I'll have two quick follow-ups.
Yeah, maybe I'll start it, and Dev Kurdikar can certainly jump in. I think like our thoughts on revenue guide that we wanted to set, given that we're talking about a three-year period of time and given that there could be a lot of variability that occurs over the next years, I mean, I think we certainly saw that over the first three years of being a public company. I think we absorbed around somewhere between close to 500 basis points of incremental margin pressure related to inflation that was never originally contemplated in our EBITDA margin guide. Yet we were able to exceed our EBITDA margin range by around 140 basis points.
I think we're trying to take a somewhat similar approach when we're setting those operating margin ranges. Anthony Petrone, I think if you sort of kind of bridge from the midpoint of our 2025 operating margin range, that calls for around 30.25% going to the midpoint, say, of our LRP range of 29%. It really comes down to two major things. One has to do with the incremental tariffs that we have factored in related to China and the U.S. That adds around, let's call it 60 basis points of a headwind. The other, I had mentioned that we do expect R&D to modestly tick up. That's due to a couple of things.
It's due to the development efforts that we need to make through kind of 2027 as it relates to development of these market-appropriate syringes and pen needle products, coupled with, I think, very importantly, trying to continue to move us along to become somewhat more cannula independent from our former parent. Importantly, I think we're sort of absorbing the costs into our LRP and our operating margin thoughts. Because cannula independence most likely would not come until after 2028, we're obviously not factoring any potential benefit in terms of cost reductions as a result of potentially moving some production. We'd never move all of the production that we currently have from our former parent because they're such a reliable supplier. I do think that post the 2028 LRP timeframe, there could be opportunities there to further reduce cost.
In terms of what could drive, say, going to the low- end of 28%, maybe versus the high- end of 30%, at the low- end, we're certainly factoring in incremental inflation and additional cost pressures as well as pricing pressures. I think at the high- end, we're largely assuming that Shaun Curtis and his team continue to find ways in order to create these annual cost improvement programs and generate cost reductions. They've done a tremendous job. I mean, every year, they are able to sort of find close to a 1% of revenue cost reduction, which is pretty amazing given we're talking about fractions of pennies, and yet they're able to do that. The low- end of the guide at like 28% really assumes that there's very, very little, if any, kind of cost reductions that would occur.
The high end assumes that we would be sort of able to generate those cost reductions in or around a similar level that we have historically done. I think we feel pretty confident in the long-range numbers that we put out there today.
Thanks. Two quick follow-ups. One is on GLP-1 generic. Would these deals be inclusive of clinical development units? I guess if successful, would you be standardized into those products on a commercial footing? Dev Kurdikar, the deck indicates we want to shift Embecta back to be a broader medical supplies company. There are assets out there for sale right now. Could you fast-track some of these using M&A as a lever? If so, what's the max debt ratio that the company's comfortable with?
Yeah. Why did you not take the GLP-1?
Yeah.
Regarding the GLP-1 question that you had, we currently are working with, as I mentioned, more than 20 different companies. For the companies that we have agreements with and purchase orders for, they are looking at the test quantities as well as preparing for launch. We are currently working on both of those items with a few companies right now.
We are part of their planned regulatory submissions. With respect to your question about development, submissions, the answer is yes, Anthony Petrone. Maybe I'll just talk just more broadly about M&A, and I'll let Jake Elguicze talk about sort of leverage levels that we'd be comfortable in.
Look, I mean, right now, certainly through this year and as we laid out in the plan, our priority is debt paydown and using our free cash flow to pay down debt to get to a level where I think we would be engaging in opportunistic M&A. Jake Elguicze in his prepared remarks said that would be in the sort of 2027, 2028 timeframe. Certainly near term, we are focused on using that free cash to pay down debt. I would never rule anything out particularly. If there is an opportunistic target available that would enhance our ability to create value faster, certainly we'd look at it. Our focus is currently on paying down that debt.
Yeah.
I think one of the hallmarks, I think, of this company, even when it was part of our former parent, was this was essentially a relatively low-growth but highly profitable cash flow generative business. That candidly, I think the cash flow generation has been muted because of all the separation costs that we've needed to incur over the last several years. I think that lack, it hasn't been as visible, I think, to the street. I think beginning this year and certainly throughout the LRP period, we expect to generate a lot of cash, again, on a relatively flattish to potentially even slightly declining operating margin environment. I think we feel very, very good about our ability to generate that $600 million in free cash flow.
I think in terms of debt repayment, it's probably reasonable to think that we would repay debt on a ratable basis. In terms of our sort of interest rate assumptions as it relates to kind of SOFR, we're pegged to the latest Fed dot plot that would basically indicate that we'd be somewhere to the magnitude of, let's call it 4.4% in 2025, trending down to around 3.3%, I think, for SOFR by 2028. Assuming that we would repay that $450 million-$500 million of debt ratably, I think that that would sort of put us potentially in the area of maybe $95 million-$100 million in interest expense in 2026, going to somewhere between $80 million-$85 million in interest expense in 2027, and then down to somewhere between, let's call it $70 million-$75 million in interest expense for 2028.
Again, assuming that we would repay things ratably and assuming those sort of SOFR rates, because we are focused on, right now, at least, the term loan bay. In terms of leverage ratios, I think that we're obviously, again, assuming sort of a ratable debt kind of paydown that I referred to, we could be in sort of the mid-twos by 2027. I think we could certainly be around that 2x mark, if not slightly below a 2x net levered mark as defined under our revolving credit facility by 2028. I think that obviously frees up a lot of balance sheet flexibility in order for us to potentially do M&A. Not that we would intend to do highly transformative M&A.
I do think that we need to sort of dip our toe into the M&A waters and gain the trust of the investment community in terms of our ability to execute on M&A, drive synergies, increase that revenue growth rate, and then get those leverage levels down. I think to the extent that we could find ways to repay debt quicker than sort of a ratable basis, I think that would only benefit us, right? Because it would take our net leverage levels lower. In terms of, I think, longer- term, I do not think we would want to necessarily keep, from an optimal capital structure stand-point, I do not think we would want to keep our net leverage levels below 2x .
I do not think we, nor do we want to have our leverage levels sort of at where we are today, which is sort of in the 3.7 x net levered mark. I think over the longer- term, I think we would probably like to target, again, net leverage as defined under our revolving credit facility, somewhere around a three-times mark. Over the long- term, with an ability to sort of flex that up or down depending on opportunistic M&A. Can we get a mic for—oh, I am sorry. Sorry.
Yeah, I got a mic. Hi, Bill Carpenter from Symetra. Maybe if you could just describe regional margins and whether there are opportunities within a particular region or the cost initiatives more broad-based. I was just trying to get a sense of, are there areas where there is more operating leverage opportunities greater than others?
Secondly, on the pricing headwinds, does the outlook consider more of the same, or is that increasing or decreasing? Thanks.
Yeah. Maybe I'll take the second question first. I think in terms of pricing, historically, we have been a price premium product in the market. I think through 2024, certainly we were able to continue to take price. I think we're taking the assumption through the LRP period that we are going to see some pricing pressure, largely as it relates to the U.S. and largely as it relates to the U.S. syringe. In terms of the margin profile, I would say, generally speaking, our margins actually in China tend to actually be the highest in terms of gross margins. Next, I would say our margin profile in the U.S. tends to sort of be kind of well above the company average.
From there, the rest of Asia tends to be in or around the company average. You get to EMEA, which is slightly below the company average in terms of gross margins. Lastly, Latin America makes up around 5% or so of our revenue. It's largely a distributor network, so those gross margins are a little bit lower, but we don't necessarily incur the same amount of infrastructure costs. I think from an operating margin stand-point, it's a little bit more closely aligned with the corporate average. Ginny Blocki had sort of highlighted an opportunity for that we essentially that the seven major countries that we operate in, we generate around 84% of revenue, that there's a long r evenue tail of 100+ countries that we could potentially go about in terms of change in market strategy.
Very little, if any, anything associated with the restructuring program that we announced on our Q2 earnings call is factored in. That restructuring effort is going to pay a benefit of around $78 million of reduced costs in the second half of 2025. It is going to pay a benefit of around $15 million on an annualized basis. A small part of that has to do with sort of go-to-market changes that we are making in international markets. Absent that small amount, none of the additional potential benefits that we are talking about in terms of go-to-market strategies or changing, maybe going to more of a distribution versus sort of a direct model and kind of recouping things there, reducing maybe some of the infrastructure costs, that is not necessarily factored into our LRP numbers right now.
Nor is any restructuring initiatives that we have not already announced.
Hi, Ryan Schiller from Wolfe. You sized the GLP-1 opportunity as roughly $100 million. Can you walk me through how you size up that figure? How many GLP-1 users does that consider? Maybe highlight any pricing differences between Embecta's needles for insulin versus for GLPs?
Yeah. Happy to do that. Thanks for the question. We spent a significant amount of time sizing the market in regards to what we thought would happen with GLP-1s.
We started with people that are on diabetes and people that have obesity 18 years or older, and then a segment of those that would actually seek treatment, and then took it down an algorithm, if you will, based on how long would they stay on therapy, how well would they adhere to therapy that was prescribed to them, and then ultimately coming up with numbers related to individual markets. We looked at it country by country and built it out in that manner based on what we know, having been in the market for a long time with diabetes, as well as what we had from different market research reports related to obesity. Once you get to that, we took it down to, okay, how much of it would be on weekly, how much would be on daily, how much would be on orals.
Then took it even further once you got down to what would be weekly GLP-1s as to what is currently co-packaged, what is not co-packaged with Pen Needles, and what do we anticipate will happen with generics as well based on what we see from the patent landscape. Built it out based on that at a country level and what we see pricing-wise, because to your point, pricing is very different market by market. We went that granular and then rolled it up to what you saw in regards to the potential for Pen Needles related to the different categories I just talked about, be it generic, non-co-packaged weekly, and then co-packaged weekly. Obviously, based on all of the numbers that we had, came up with the total addressable market and then what our share would be and dollarized it.
Two sources of inputs.
Obviously, we looked at patent expirations because that obviously tells you which country becomes available when. That's obviously an estimate that's factored in there. Secondly, we've been working closely with the potential generic entrants. Obviously, we got information, shared information with them as well. That served as an input into our estimates as well.
Three questions. One on pricing. Are you seeing any changes in behavior or dynamics within the generic manufacturers that might be taking your pricing assumptions lower over a period of time? Are you seeing them increase in types of packaging or their product base or anything on that front?
Not yet. We're not seeing any meaningful price pressure associated with that. Obviously, in the second half of the year, we are factoring in some additional pricing pressure in the U.S.
Again, normally related to recently announced contracts that we had signed and what those contractual agreements had indicated. We are factoring that in, and we are factoring that in throughout the LRP. We are not seeing anything associated with that right now.
I get the inflation impact and the pricing decline on your views around the modest gross margin decline, but can you bifurcate between your core business in terms of your expectations on that margin decline and what the operating leverage or contribution margin could look like on the new business? I get it, you are being conservative around the GLP-1 pricing is going to be lower, but just also trying to better understand, given the fact that you are leveraging your fixed costs, what that opportunity looks like with all the other opportunities you have coming.
Yeah. Do you want to?
Yeah.
I would say, largely speaking, these new revenue opportunities that Jake Elguicze laid out, right? I mean, I think it's fair to assume that the impact on our contribution margin would be accretive because we are leveraging a lot of the same SG&A that's essentially semi-fixed, if you will, not P&L. Sort of point number one. Point number two is, particularly in the GLP-1 space, the generic GLP-1 space. Right now, the product that we provide is all in retail packaging. But when you're working in the B2B business, it's all going to be bulk. Obviously, there is an incremental benefit over there in addition to the fact that you don't have incremental SG&A added. I think it's fair to assume that some of these new revenue opportunities, the contribution margin is going to be accretive to our operating margin.
Lastly, I know your maturities are several years out and you've laid out your targets around leverage, but do you have any targets from a credit rating stand-point? Can you just walk through your conversations that you're having today with them?
Yeah. I'd like to think that we have positive relationships with the credit agencies that follow us. We have ongoing discussions with them each and every quarter to provide them updates in terms of where we are and where we're going. I think that they have a fairly good understanding of Embecta. I think in terms of the credit rating, I don't think that we would want to be investment grade, right?
I think getting to a point where maybe we are like a solid 4B rating split between S&P and Moody's, I think is something that we would sort of look to attain over time. I think that that would be sort of a nice ratings profile that would allow us to do M&A without doing anything highly transformative, but then also having an ability to sort of lever and delever and use our balance sheet in kind of a very prudent and, I would say, conservative way. I think that's something we certainly want the flexibility to be able to take advantage of opportunistic M&A if it were to come about.
On developing market appropriate products, I believe Embecta is kind of the dominant market shareholder in most markets. Can you just maybe give a quick history lesson?
Why are these markets less than 5% share and what changes are you going to make to your products to outperform in these markets?
Yeah. I think it is fair. The markets we've been in, and you saw in the presentations, right, 80 %+ have been developed markets. We certainly have a leading share of category in those markets that we've maintained over time. Even beginning with pre-spin, there were markets that we stepped out of because we didn't think that the features that our products have that we're very proud of that allow people to have, I would argue, a superior injection experience are the right products for those markets. That essentially shows up in price conversations or in tenders where if you're a point-based tender system, a lot of emphasis is placed on price.
There were markets that we either stepped out of or, frankly, historically did not participate in. What our goal here is with market-appropriate products is to use our expertise develop products that are more suited. I am going to let Ginny Blocki talk about sort of what some of the differences are between the products that allow us to be priced at a premium in the markets we are in versus these new products that will allow us to enter segments, as you saw, where our share is less than 5%.
A lot of the markets that we are talking about are more the emerging markets, even within EMEA. You are talking about where people are looking for something since they are paying out of pocket that is more affordable.
Although our premium products are, as Dev Kurdikar said, of high quality, what we're expecting and what they're looking for is something that would have maybe a different bevel or a different wall thickness that would bring down our pricing to something more affordable and that still has the same high quality, which I mentioned during the prepared remarks, but is a little bit less out of pocket for them within those markets themselves. The teams have recognized that there truly is some opportunity where we don't have much share within select segments.
The packaging will be different. Obviously, the countries or markets that we will enter into with these products will be different than the ones that we are currently in today. I think we are going to be careful to target these products to where the specific need and the opportunity is.
A few questions from the webcast, two on revenue and one on margins. First, a clarifying question with respect to the $100 million opportunity cited for GLP-1s. Is that a cumulative revenue number through 2033 or an annual estimate for 2033?
I would say that's the annual number that we think that we could get to. Again, I would say at least $100 million in terms of revenue by 2033. It certainly could be something that is more than that. That is the annual number that we are talking about that it could reach by 2033, at least, which obviously, given a billion dollars in revenue for Embecta that we sort of are today, a billion, a billion one, I mean, obviously, that's a pretty meaningful uplift to what we think our current revenue base is. What was the second question?
The next one on revenue is, as we think about Embecta's future revenue sources, what sorts of products could you sell through your existing commercial channels? Are these products limited to diabetes, or could they be anything that goes into the retail pharmacy channel?
Yeah. I can start that, and Ginny Blocki, feel free to augment, right? I mean, I think the examples that we showed are diabetes-related. That's what we started with. But they absolutely do not have to be just diabetes, right? I want to remind everybody what we want to do. We want to take our expertise, the channel reach that we have, and the manufacturing competency we have to widen our portfolio more into broad-based devices. Yes, diabetes will always be an important part of our business as far as we can see, but we are not going to restrict ourselves to diabetes.
It has to be something that, if it's the retail channel, we want to exploit. At the same time, we showed you an example of a pump. That's because that's in a country where we do call an endocrinologist, a hospital endocrinologist. It does not have to be one size fits all either. The examples that we showed you were very country-specific. I think in the material that Tom Blount and Slobodan Radumilo went through, you saw how targeted our go-to-market is for those major markets. We want to use opportunities to leverage that. Like I said, it does not have to b diabetes-oriented.
Any more questions? All right. That concludes our event for today. Thank you for joining us on this rainy New York morning.