Hi all. It's my pleasure to be here today with you. My name is Caroline Borowski, and I'm a member of the J.P. Morgan Healthcare Investment Banking team. With me is Dev Kurdikar, CEO of Embecta. Thank you and welcome.
Thanks, Caroline, and good morning, everybody. It's a real pleasure to be here and share with you the progress we've made and the priorities we have for our business in the coming years. I'm joined here with my colleagues, Jake Elguicze, our Chief Financial Officer, and Pravesh Khandelwal, our Head of Investor Relations. What did I do? Here's our FLS language. And let me start with just Embecta. We are a leader in the global marketplace for insulin injection devices. We are the number one producer of these devices in the world. We make eight billion units at three facilities, and they are used by, we estimate, approximately 30 million people around the world in over 100 countries. So wide reach. We have 2,000 employees. Over 600 of them are commercially focused, and within that group, half of them are in emerging markets.
That's particularly important because we do believe that there is going to be disproportionate growth in emerging markets over the coming years. The products that we make are shown here, and we have leadership across the injection platform in each of the product categories that we participate in. We are number one in pen needles globally. These are pen needles. They're used with insulin pen for insulin delivery. Also number one in syringes, which are used to draw insulin from insulin vials and then used for injection. And then we are also number one in safety products. Safety products are engineered for needle stick protection and typically used by caregivers who need to deliver insulin to patients under their care. We became an independent company now approaching three years ago.
Prior to that, we were a division of Becton, Dickinson, and when we did become independent, we set a three-year roadmap of strategic priorities that we wanted to execute on. And they're shown here. Number one was strengthen and optimize the core business. Clearly, we were separating. We were becoming independent. It was important that we maintain our revenue, not lose our focus on our customers and the people we serve, the people that use our products. We had to separate the organization and stand up the organization. It's worth recalling that when we separated, essentially the people that came with us were the people in our manufacturing plants and the commercial-focused employees. So all the back office, finance, IT, HR, we had to stand up, including finding offices around the world for our people.
And the third one was we were going to invest in growth, and we invested in the insulin patch pump development. I'll talk a little bit more about that. And at the same time, we laid out our projections for what our financials would look like over the next three years or so, so through the end of our fiscal 2024. And we said our adjusted constant currency revenue would be about flattish, and our adjusted EBITDA margin would be approximately 30% after we absorb all those stand-up costs. And I'm very proud to say that as we completed that period in 2024, our team accomplished what we set out to do. And here are just some proof points. We were named exclusive or dual preferred brand with three of the top Medicare Part D players. This is an important win for us.
Seniors in the U.S. are more likely to have diabetes, and because of age, perhaps more likely to need insulin. And we won several other contracts as well that are listed in this blog. We did a lot of separation and stand-up work. We implemented an ERP system. We set up our own distribution network. So we moved our products that were flowing through some 30-plus DCs that belonged to our previous parent to now our own distribution network. And we set up back office operations as well as customer service and support operations around the world. And now 98% of our revenue flows through our own systems and processes. We also completed the transfer of the Suzhou, China facility, an important plant for us that at spin still belonged to BD.
And we had to go through a pretty complex process involving governmental approvals, product registrations, quality inspections before we got that transferred. It involved a shutdown of the plant for a period of time that was required by the process as well. And we got all of that done. And then, as we had said, we had been invested in an insulin patch pump, and our team did a remarkable job. And Labor Day last year, actually, this conference last year is when we had announced the filing of the insulin patch pump. And then nine months after that, we got clearance. We also are doing what we can to take advantage of the GLP tailwinds. And I'm going to talk a little bit about that as well. And we introduced a small pack for patients in Germany who are using GLP-1s.
Now, all of this occurred in a pretty challenging macro environment. We were faced right after spin with rapidly rising inflation, rapidly rising interest rates. Obviously, geopolitical conflicts have broken out since then. And through all of this, our team persevered because all these external impacts really caused us to have to absorb about 500 basis points of margin pressure. And in spite of that, we delivered results that were ahead of those expectations that we had laid out prior to spin. Our adjusted constant currency revenue, CAGR, was 1.3%. Our adjusted EBITDA margin was 31.4%, and late fiscal 2024, we initiated a debt paydown plan because at spin, we had about $1.65 billion in gross debt. So now the question becomes, where do we go from here? And we have now embarked on the next phase of our transformation back to growth.
And here are the priorities that will guide us for the next several years. We have to strengthen our core business. We have to get brand transition done, which I'm going to speak about later as well. But the core business, I mean, it's a stable, strong business, and it really enables the execution of our second priority, which is expanding the product portfolio. We recognize that transitioning our company back to growth is going to need addition of new products to our portfolio. And then finally, we want to increase our financial flexibility because our net leverage at the end of 2024, fiscal 2024, was about 3.7, and we want to bring that down over time. And so these are really our three priorities going forward. Now, let me just go through each one of them in a little bit more detail.
This page shows you, and this is for the first time we are showing this publicly, what our key product performance has been over the last five years, and it shows you by product categories. It goes from fiscal 2019 through fiscal 2024, and the first thing, even before I dive into the numbers, I'd urge all of us to just think about what was going on over that time period. Obviously, we lived through the COVID-19 pandemic that happened in this time period, but there were a couple of other things that maybe impacted the diabetes sector a little bit more, and that was the rapid adoption of GLP-1s, as well as the continued adoption of using pumps for insulin delivery, specifically in Type 1. That penetration rate probably moved from the low 30s to the high 30s over this time period.
Now, if you look at the pen needle constant currency growth rate, that's 2.3%. And in spite of all these factors I mentioned about pen needles, which is our single largest product family within the constellation of products that we have, kept growing strong through it. And this really speaks to the commercial and operational strength of the team. But it's also an indicator of the chronic use, medically necessary characteristics of this product. If you go to the third set of rows, the safety products, those grew at 2.9%. If you sum up pen needles and safety products, that's 86% of our fiscal 2024 revenue. Syringes, you can see declined by about 6.3%. And the decline in syringes is, we believe, following the decline in insulin vials.
If you look at what's going on with insulin in the U.S., particularly, you will see that insulin prescriptions are flat to maybe slightly down, but that decrease has been driven by the decrease in insulin vials, and we can talk about why that might be. Why are vials declining at a disproportionate rate compared to pens, and I can think of a few factors that might influence it. There have been formulary changes. There have been manufacturer discontinuations. Healthcare providers still counsel patients to use pens and shift from syringes or vials to pens because obviously it's easier to dose, maybe more accurate to dose as well, and then, as I mentioned, because this was a COVID-19 pandemic that covered this period, there was obviously the impact of patient mortality because, as you remember, seniors and people with diabetes were more disproportionately impacted.
So the takeaway from this page is, in spite of all the separation work, in spite of what was going on in the external world, the key product families that we have, pen needles and safety products, performed quite strongly. What we do need to do now in our core business is execute a seamless brand transition plan. And what I mean by brand transition in the most sort of practical sense is take a look at the visuals in the bottom half of the page. That's an example of product packaging. The left-hand side is the old, or actually the current packaging. The right-hand side is the new packaging that we are moving towards. And the new packaging design was based on significant research in multiple countries. And you will see some commonalities. First, the color schemes remain the same.
The product name, Nano 2nd Gen, in this case, remains the same. The placement of the number four, which is the length of the needle, remains the same. But at the same time, we are providing a more modern, refreshed look to our packaging. Now, this is a pretty complex project because you can imagine when you're trying to change product packaging, you have to work all the way through your supplier base, through the manufacturing process. You've got to manage inventory. You've got to get product registration done and remain in compliance. We are starting that this year in fiscal 2025 with U.S. and Canada, then we'll move to Europe, and then the rest of the world. We expect to be complete with this in the next couple of years, and that is now the only real separation program that's remaining of any magnitude.
The second priority, as I mentioned, was we need to expand our product portfolio. And the way we are going to do this is we want to leverage the strengths that we naturally have in the organization. So the first thing to consider is our global commercial channel. It's extremely strong. We have 600 commercial full-time members, as I mentioned, 50% in emerging markets. We serve more than 100 countries. But perhaps what is not illustrated on this page is that in the countries we serve, our go-to-market is very customized. It's very fit for purpose. So depending upon which country we are, we call on pharmacies. We call on hospitals. We call on prescribers. We work with distributors. In some countries, we have our own sales teams. In some countries, we use distributor sales forces. We have capabilities in tender management, and we work with reimbursement bodies.
That's a pretty strong strength that we have, and we want to utilize that. And that's backed up with our distribution network. The map shows our distribution network. You can see it's in over 12 countries. And we have established partnerships with blue chip distributors and 3PLs that help us with this. So you can see that our commercial strength involves we can take product that won't be manufactured anywhere in the world, really, transport it to our distribution system, get it through the commercial channel, and get it into the hands of patients who need this. And we want to leverage this by seeking to distribute products that could be additive to our product portfolio. And over time, we want to evolve into manufacturing other products as well that leverage our strength. We start with a pretty incredible foundation.
We are the largest global supplier of injection devices: three world-class facilities, highly automated. But again, I think the magic sauce that really distinguishes us as a world-class manufacturing organization is the culture, the talent, and the operational excellence that's now been embedded into the DNA of our team. There is continuous monitoring of KPIs. There are daily stand-up meetings, discrete work plans. We know systematically how to manage a global supply chain and distribution network. We manage over 260-plus suppliers. And we have specific expertise in injection molding of plastic and assembly of plastic to make medical devices, currently each one of which enters a human body, operating under a quality system that's been audited at least a couple dozen times by external bodies over the last two and a half years. That's a pretty strong strength. I mean, I said we have 2,000 employees.
More than half of them are in our manufacturing organization, and over time, we want to see these are the strengths we have. What other medical products could we manufacture, and either candidly, somebody else can distribute them if they have the right channel, or if we have the right channel, we could distribute them. The third priority that we have is to increase our financial flexibility. We announced a couple of months ago the shutdown of the insulin patch program. That was a difficult decision. Absolutely. This was a team that had delivered, gotten the filing done, gotten clearance done, but it was a very pragmatic capital allocation decision. Continuing the program would have meant years of continued investment in clinical studies, in the commercial organization, and a marketplace that was evolving and competitive intensity was increasing.
It would have squeezed out the possibility of either paying down debt in a more substantial way or making other investments, so we decided to terminate this program. We announced that there would be pre-tax cash charges of between $25-$30 million and non-cash charges of between $10-$15 million, but we had spent somewhere between $60-$65 million on this program in 2024. That is now, if you will, dropping to the bottom line, and this will allow us to pay down debt in a more substantial way. We said we would pay down approximately $110 million this year, so to conclude my presentation, just let me run you through the latest fiscal year results. This shows the geographic breakdown of our results. U.S. and Canada, 1.1% in adjusted constant currency revenue growth total for the company, balanced across U.S. and international. Slightly different dynamics at play, though.
In the U.S., mostly driven by pricing, offset by some declines in volume. International was mostly a volume story, volumes going up in Asia, China, Canada, offset by some declines in India and Latin America. And then we also showed the product family, CAGRs across 2024 versus 2023. And you will see pen needle growth of about 2.6%. You will see safety growth of about 2.5%, and syringes declined by approximately 9%, all consistent with the trends I'd shown earlier. So to close, the last now almost three years have been a lot of work in separation and stand-up, but we are happy to have some of these complex separation projects behind us. The priorities for the next three years are clear. We need to keep strengthening our core business. We need to expand our product portfolio. We need to increase our financial flexibility, potentially would create opportunities for M&A.
We are excited about the potential for this company and look forward to sharing more on the analyst day that we are planning for spring of this year. So thank you for your time and attention. And with that, Caroline, happy to take any questions.
Awesome. Thank you. So to start, I'd like to take a step back and reflect on fiscal year 2024. It was a year of significant progress for Embecta. You substantially completed all separation and stand-up activities from your former parent while avoiding any customer disruptions. You were able to continually increase your financial guidance as you progressed throughout the year and ultimately exceeding your most recently provided expectations. Then at the end of the year, you announced a discontinuation of the patch pump program. So as we think about all this, what accomplishments are you most proud of during the year?
As you look forward ahead, now that the decision has been made to discontinue the insulin patch pump program, what is your vision for Embecta over the next three to five years, and what are you specifically looking forward to?
Yeah, thanks, Caroline. Maybe I'll start, and Jake, you can augment as necessary. So as I reflect back on the last three years, and some of this I covered in my remarks, it's been a remarkable journey. I remember when we spun off and we were about to start our ERP implementation project, we had to start by building an IT team. We had to select vendors that were going to help us undertake this journey.
I think those in the audience that have dealt with ERP implementations before, you know how fraught they are, how complex they are, and especially in our case where we are deploying an ERP, setting up a new distribution network, setting up shared services capabilities all simultaneously. We had a time crunch to get it done. We wanted to remain in compliance with the private letter ruling that had been issued, and so didn't want anything to jeopardize the tax-free nature of the spin. I'm very proud that the team did it all now. Now, I'll admit, it was expensive. Over the life of the separation work at the end of fiscal 2024, it's probably cost us around $400 million to get it done. This is expensive work.
But the one thing we wanted to make sure that we didn't jeopardize was the ability of the people that use our products to be able to walk into the pharmacy they use and be able to have access to our products. And I'm particularly proud that we did all of this work with literally zero customer disruption. The second thing I'll say is, while we were doing all of this work, we were a brand new management team, obviously setting up new operating mechanisms. And we wanted to earn your credibility as investors. So I'm also proud of the fact that as we went through this period, including last year, as you mentioned, Caroline, we were able to consistently either meet or beat the expectations and the forecast that we had laid out. I think the patch pump decision, as I mentioned, was difficult. No question about it.
I mean, this was a program that had continued under ours that had been actually initiated under a former parent. And those of you that have followed Insulin Patch Pump over years know how difficult it is to get those pumps approved. And here, too, we started with first building the team and bringing in capabilities that the company didn't have much of, including software, which, as you know, for our traditional products, there's not much software in our products. And so the team did great work in building the product, working with the FDA, getting clearance in approximately nine months. But then we had to terminate the program. And I think the reason beyond what I said is just as you step back and go, look, there are new entrants coming into the pump space. The marketplace is evolving. There's no question about it.
What that meant was, while we strongly believed that our pump had features that were differentiated, that there was value in the asset, we would just have had to spend more to get there. And that would have certainly impacted pretty significantly our ability to pay down debt. So it became a capital allocation decision. And we sort of chose to focus on bringing our debt levels down. We did a market check because once we got clearance, we scoped out the market to see if there were any potential third parties that might be interested in acquiring those assets. Unfortunately, it didn't turn up any realistic possibilities. And so we made the prompt decision. Everything between clearance to the announcement of the decision was a few months. And in between, we did a market check. Jake.
Yeah, so just to add to what Dev said and maybe thinking about where we're going moving forward, I think over the last two and a half years, obviously, there was a fair amount of time, expense, and cash that was spent towards separation and stand-up activities while trying to make sure that the business remained as stable as we possibly could, and I think we largely accomplished that. I think as we move forward here, and going back to sort of the summertime into the fall, we sort of stepped back and looked at our business and said, what really are our core competencies, and I think it really came down to two things. It came down to the fact that we have three highly automated manufacturing facilities, and we make eight billion units of single-use plastic disposable product.
So as we move forward here, what else could we put through those manufacturing facilities and sort of broaden out Embecta to be more of a broader medical supplies company in the future? So I think that's one focus moving forward. And then the second is just leveraging our commercial footprint. As Dev talked about in the presentation, we have over 600 commercial associates globally around the world, many of which are in emerging markets. And what other products, again, kind of coming back to broadening the company out into more of a medical supplies company over the next three to five years, what other types of products can we put into their bag, whether it's through distribution agreements, whether we end up manufacturing product ourselves and selling it, or manufacturing product and other companies end up getting that into the market through their commercial channels?
So I think there's real opportunities for us moving forward. Additionally, I think there's significant tailwinds from GLP-1s. I think that we have an opportunity to take advantage of. If you think about how GLP-1s are sort of administered today, they're largely administered through what's called an autoinjector, a single-use autoinjector. And I think we've been having a lot of conversations over the last 15 to 18 months with a variety of GLP-1 manufacturers, many of which are on the generic side, regarding the use of our pen needles with what they believe will be an ever-growing form of administration of GLP-1s coming in the form of pens. So sort of transitioning from a single-use autoinjector to a multi-use pen that's going to require our pen needles in many respects.
So I think from an organic standpoint, that's probably the single biggest organic growth opportunity that we have. But in the near term, I think our focus is going to be on continuing to execute on these restructuring programs, taking cost out of the organization. We announced, obviously, the shutdown of the pump. I think as we move forward here, there's opportunities for us to continue to take cost out of our structure. And that's certainly something that we're looking at. I think second then is obviously a real focus on continuing to reduce our net leverage, and not just from a net leverage standpoint, but actually reducing our gross leverage as we move through 2025 and 2026.
We said on our earnings call that by the end of 2025, we would expect our net leverage to go from sort of 3.7 times at the end of 2024 down closer to around a three-times mark by the end of 2025. And I think there's opportunities to take that even lower into 2026. And I think that's really going to allow us to create a pretty significant amount of financial flexibility as we move forward here. Thank you.
Thank you. That was awesome. So moving on to some developments, since you last reported your year-end earnings and provided fiscal year 2025 guidance, given that the restructuring was intended to strengthen financial flexibility, are there any updates on potential M&A partnership or distribution opportunities that you can speak of?
We'll certainly cover more on analyst day in spring.
But now that the pump program has been terminated, and I should mention, we said the restructuring would be complete in the first half of 2025. And certainly, that's all on track. But perhaps sort of what I should also mention is that we have sort of reorganized and refocused the organization in some cases with new leaders now on our core business. And there is renewed focus now on finding opportunities of products to distribute through the organization, as well as scoping out what other medical products we might be well suited to manufacture. So it's too early to name any specifics, but certainly, we'll provide updates as the year goes along. And certainly, this will be a topic that we'll cover during analyst day.
Great. And you mentioned that you expected to achieve between $60 million and $65 million in annualized cost savings from the restructuring.
Are there any additional cost optimization opportunities you've identified since then?
Yeah, maybe I'll start us, and Jake can augment as well. I mean, let me give you the broad picture. So over the last three years, given the time pressure we had to stand up our organization, we did a lot of, call it lift and shift, took sort of organizational models and operating mechanisms that existed in a previous parent and sort of copied them over. Now, I think over the next few years, we just need to optimize that, make sure that the models that we have, the resources that we have, the way we operate is suited for a company of our size. And so certainly, we'll be looking at that over time.
I mentioned we are in over 100 countries, but it's easy to be in that 100 country if you have a bigger portfolio of products that you're serving. Because being in a country, whether it's $1 million in revenue or $100 million in revenue, there's first just a step up in cost to be present in a country. I think that's something that we will look at over time as well. So certainly, we are going to make sure that we put time and focus on just optimizing the organization, driving efficiency as much as we can so that we can free up cash to really keep that debt under control and keeping more of it down. Jake?
I think you covered it well.
I mean, just coming back to the pump restructuring, I think everything's on track as far as that is concerned to drive those significant cost savings in 2025, and as you mentioned, I think we're going to continue to look for ways to take cost out of the system moving forward.
Great, and now maybe moving on to some product and market developments. Are you seeing any changes in market trends in the various geographies you participate in that you can speak of?
Yeah, and maybe, Caroline, I'll take the opportunity to talk about GLP-1s as well, which obviously has been a topic of investor focus for a couple of years now, and I think our fundamental view on GLP-1s haven't changed, but with perhaps now the disclosure of our product family performance over the previous five years, I can add a little bit more color.
So if you think about GLP-1s, I mentioned insulin TRXs. And I'll talk specifically about the U.S. because that's where the GLP-1 growth has been the most. Insulin total prescriptions sort of flattish to slightly down, mostly driven by vials. Ozempic was launched in the U.S. in 2018. And you saw the growth in our pen needle portfolio over that time period, 2% plus. Globally, I can comment that similar trend in the U.S. as well. Pen needles have grown. Still no evidence that certainly I've seen that GLP-1s arrest or stop the need or eliminate the need for insulin. They do slow it down, we believe. But the question for us is, is the delay in insulinization any more or greater than the delay in insulinization that was caused by prior drugs? Because GLP-1s are substituting the prior-used drugs.
Now, from an opportunity standpoint, this has gotten significantly more interesting over the last year, year and a half. As you've seen, GLP-1s indications for obesity have come through. An expansion of the patient TAM in obesity is obviously a major expansion of patient TAM for us. The number of people that are obese are far greater than the number of people that are using insulin today. Secondly, as forms of GLP-1 deliveries sort of as GLP-1 entrants grow or launches occur in countries, we are observing that more and more GLP-1 entries are in the form of pen injectors versus autoinjectors. Obviously, just a more efficient form of GLP-1 delivery, a multi-dose pen versus a single-dose autoinjector. And if you are using a pen, so Mounjaro in a KwikPen, KwikPen was the same pen, is the same pen that's used for insulin.
Our pen needles are what are needed to deliver that drug. And so as there is a shift in the delivery format from autoinjectors to pen injectors, we naturally stand to benefit. Our pen needles can be used as they are. They're generally indicated in many countries for the subcutaneous injection of drugs. In certain countries, we do have a GLP-1 indication as well. And so there's this natural tailwind of as GLP-1 adoption increases into a larger patient TAM, as the format moves towards pen, people are going to need pen needles. Now, that can benefit us in one of two ways. If you are in a country where GLP-1s are being introduced in pens, but they're out of pocket, and in Germany, we did this, we introduced small pack. So you didn't have to buy a 100-count box of pen needles.
If you were picking up a three-month prescription for a GLP-1 that you're paying out of pocket for, you could get a 14-count box of pen needles that was sufficient for a three-month delivery of a GLP-1. The second, and I believe might be a bigger opportunity, is we have been working with more than 10 generic GLP-1 potential entrants. And we are in active discussions with them for co-packaging of our product with their generic GLP-1s. And that's a big opportunity because once we sign agreements with them and we become part of their submissions, then obviously our pen needles will get co-packaged. Now, all this incremental volume that we could potentially get from the use of our pen needles to deliver GLP-1s, we don't need any significant capital investment, incremental capital investment for. The product does not require any changes.
We believe it has the data necessary to support co-packaging requirements. And you can imagine that all that incremental volume, the margin drop-through is going to be certainly higher than our corporate average. So this is why we believe that the adoption of GLP-1s is probably our largest sort of organic growth opportunity that we have, and we are very excited about it. With respect to other trends in the marketplace between developed and emerging markets, look, emerging markets will continue to be a source of growth. And there is disproportionate, first of all, the base population growth is higher. GDP per capita is rising, and there is disproportionate growth. More than 70% of the growth in the number of people with diabetes over the next couple of decades is expected to be in emerging markets. And so that trend hasn't changed.
With respect to developed markets, I already talked about sort of what we are observing for insulin in the U.S. In the U.S., we did say in fiscal 2025 in our guidance that pricing in the U.S., which has historically been strong for us, is going to be challenging. This is just a year where there were some natural sort of customer renewals, long-term contract renewals taking place. And certainly, as inflation has shown some signs of subsiding, obviously, price increases in this environment have gotten a little bit more challenging. But all of those thoughts were incorporated in the guidance that we put out in fiscal 2025 for fiscal 2025.
And maybe just moving on to the debt and financial flexibility piece a little bit more. Your fiscal year 2025 guidance assumes that you will repay approximately $110 million in debt.
Are you considering additional measures to accelerate debt repayments beyond the $110 million planned for 2025?
Jake, would you take that?
Yeah, sure. So maybe just coming back to the separation activities over the last couple of years. As Dev mentioned a bit earlier, we spent a little over $400 million in terms of those separation activities over the last two and a half to three years. And I mention it because I really think it's been something that really has sort of masked the free cash flow capabilities of this company. When you think about this company, you should think about one that is a very, very stable company, highly profitable and cash flow generative. And I think now that we're through separation, you're really going to see that play out over the next several years.
We do have some one-time costs that we need to incur associated with brand transition and with the shutdown of the pump program. But we're well on track in terms of meeting the $110 million commitment. And when we achieve that, leverage levels by the end of the year, again, are expected to sort of go from around the 3.7 times mark that we ended 2024 down closer to the 3 times mark by 2025. And we're certainly committed to reducing leverage even more into 2026. And I think that's really important because it's going to free up that additional balance sheet capacity to make those investments, whether it's into the organic initiatives to broaden out the company and become more of a medical supplies company or do things from an inorganic M&A standpoint.
Awesome. Well, I think that wraps up our time.
Thank you all for coming, and thank you.
Thank you all.