Okay. Good morning, everyone. I'm Guy Featherstone, Investor Relations. Before we start, I'd like to remind you that any forward-looking statements or projections made by Hikma during this call are made in good faith, based on information currently available, and are subject to risks and uncertainties that may cause actual results to differ materially from those projected. For further information, please see the Principal Risks and Uncertainties section in Hikma's annual report. Thank you for joining this Q&A meeting for Hikma's 2025 full-year results. Our pre-recorded presentation is available on our website, and this will be a Q&A session. We're joined today by Said Darwazah, CEO, Mazen Darwazah, Executive Vice Chairman and Deputy CEO, Khalid Nabilsi, Deputy CEO, North America and Europe, Hafrún Friðriksdóttir , President, US and Global Head of R&D.
We're also joined by Bill Larkins, who heads up the US Injectables commercial business, and we have Areb Kurdi, recently appointed Acting CFO, and Susan Ringdal, Investor Relations, also in the room. With that, I will hand over to Said.
Thank you very much, good morning, everybody, and to my old friends, hello again. The decision for me to take over as CEO again was not really a very easy decision. Giving up the beach and the sun and the good life was difficult, but I really felt very strongly compelled to do this. Okay? I remember before we IPO'd, we were discussing what the ideas of IPO-ing and not IPO-ing, and my father saying, "My worry is that one day the team will lose sight of the long term and start looking at short term and short-term wins. This is the only thing that I'm worried about." Frankly, in many ways, this is what happened.
I think the company had sort of started looking at short-term wins and fixation on margins of the injectable, and so on, and really, you know, lost track. That's why I felt very, very strongly about coming back again. As you know also, I had to. You know, I decided to give up the chair position to concentrate 100% for the next 2 years on the CEO role. I want to also remind you that last time when I came in, we had a similar situation with the Rx business. The generic business was also doing not very well when I had to step in back again, and for a period of 1 year or so, everybody was on a, you know, on us, saying, "Get rid of this division. It's weighing you down.
You know, why are you keeping it?" We said we will do what's required. We set reasonable targets of $100 million-$130 million in EBIT, and we said we will fix it. Here we are a few years later. We're looking at that business. It has margins of close to 20% and EBIT of 200%, $200 million or so. We've done this before. We feel that we know exactly what needs to be done. It really is not a complicated formula. It's a simple formula. You need to do the right investments. You need to get the right people, the right talent, and take quick decisions. As I've said this morning, my focus is very clear. Number one, we want stability.
We want these 2 years where people can relax and focus on what is required for them, rather than worry who is going to come in and what's going to happen. We're reassuring our people, our stakeholders, our investors, this is... Hikma is a very, very strong company, and we have a slide that shows the CAGR of the last five-year growth. This company has consistently delivered growth, and quite good growth. Also, I'd like to remind you all that we have EBITDA margins of 25, while many of our competitors are striving to get to 22. The second thing is agility. We want to implement a structure of quick decision-making and to allow people across the board to take these decisions. We don't want the decision-making to be centralized with one or a few people or the executive committee.
Rather, we need to empower people across the board to take decisions. I've always said companies that empower their youngsters, they're under 40 crowd, are the ones that will be here tomorrow. Those that do not will disappear. We'll be focusing on empowering everybody across the business so that we take these decisions. Investment, we have to accelerate investment. We have to take the investments that we need to do. One of the first things we've done is we've taken the R&D budget out of the segments, so the segment heads cannot play with the R&D budget to achieve their targets. It's now a corporate decision. We have a budget for it, which is an aggressive budget. We have spent last year building the team. As you remember, we acquired a great team in Croatia.
Hafrún joined the company, what, two years ago now, and Hafrún has a long track record in R&D, and she is directly in charge of the R&D team. The other things we need to do is hire the right people. Jon took over as Commercial Head of North America or U.S. Injectables, and immediately said, "We need to hire so many people. What are you doing? We need to do this." We said, "Jon, go ahead and do it," and he's already hired so many people and added to the team. We also hired a supply chain. We have now a fantastic supply chain team in place that will be working to make sure that we don't have bottlenecks across the group....
We are still looking to hire some more people, like head of CMO. We are interviewing now. We want to hire somebody that has a lot of experience in CMO, because we feel very strongly that Hikma is well primed to be a major CMO supplier. Finally, what I started by saying, the fear of my father when we went, IPO, long-term growth. Focus on the long term, and that's what we are doing now. We are focused on the long term. We are doing the right investments. We are adding, as we said, the R&D budget is much higher than it was before.
I think we're targeting 5%-6% now to spend on R&D, hiring the right people, giving the plant managers the decision to buy the right equipment when they need it, not waiting for, you know, central engineering to come before they can buy that. All these changes that we are taking, all these changes we are implementing, I think will be excellent for the future. I think we have to look at the structure that we are, you know, saying. Why this new structure? Some people have said it looks too complex. In my opinion, for me at least, and for the team, it's a very simple structure. The MENA team is a fantastic team, strong team that has been doing an excellent job for the last 40 years. Hikma this year was number one company in MENA, among all companies.
This is a big deal. It's the MENA team that has delivered this. Mazen and his team have been doing this. It was a no-brainer that, you know, the injectables in the MENA report to them, instead of being a distraction for, you know, the whole team. Europe, and let's say, North America or USA, they share many plants and they share the products. Although doing business in Europe is different, but it's the same products and the same manufacturing teams. Khalid has been with us for quite some time now, and he has shown to be doing a great job. He understands this business, and we believe that it was time for him to step up and take a strong P&L position. I am very comfortable that he will do a great job.
Hafrún, since she's joined the company, has just wowed us all. She has done such an incredible job with Rx, such an incredible job with the with the R&D team and hiring the right people and getting the right things in place. At some point, we will be sharing a clear R&D strategy for everybody. We are more than comfortable that with the help of Jon and his team, and the Rx team that has already proven to be an extremely effective team, we are very confident that this is the right way to go. We believe it's an extremely good company. We're in a very good position. We have a strong track record, a very strong track record of growth. We will be investing heavily in the next 2 years, and we know that we will go back to the...
Moving forward, we will go back to much stronger growth than what we have shown. Although what we have done is still quite good, we believe that we will do much better than that.
Do I need a microphone or mic?
Yeah, mic. Just one second.
Thank you. Thanks. It's James Gordon from Barclays. Maybe first question just on the organizational structure you mentioned, and I do follow the logic about having people in each geography running the geography, but then at least your reporting, I believe, is still injectables, Rx, and branded. Might you actually just change the company and make it by the three geographies, rather than the three types of division? Ultimately, who is ultimately responsible for injectables now? It seems that lots of people have got responsibilities. Is the first question, maybe if I break them up.
We said that for this year and maybe for the foreseeable future, we'll continue to report the injectable margin, you know, results, because we didn't want to say, you know, "Why are you running away from that?" The reality from a management point of view, when you look at Europe and the USA, it's 90% of the injectable business. As I said, it is very different from the MENA injectables. The MENA injectables, there's a lot of products that are in-licensed and, you know, brought up from outside, while the U.S. is much more focused, Europe, on manufacturing. Khalid, Hafrún, obviously, but ultimately, Khalid is in charge of the U.S. and Europe and will be in charge. Of course, myself, I will be working very closely with them.
I think this gives us the opportunity to really focus on the business. You know, I think just forget the tail end, which is the MENA injectables. I'm, you know, as I said, I'm very comfortable that the MENA team will do a much better job than before. The bulk of the business now, there is a clear focus on it, and we will be reporting geographically as well as segmentally for the foreseeable future.
Thank you. Maybe just the second question would be: what is the outlook now for injectables, as in what's going to make it grow faster? Is the idea that now you've reset the margin to the level of this year, but you'd have a similar growth rate on the top line as you were previously hoping for?
First of all, as we said, the amount, the budget for the R&D is much bigger than it was the year before. Actually, if, you know, if R&D growth was similar to the years before, then the results will be much better. We said, "No, we have to do this. We have to take this decision now. We have to invest." Again, it's investing. There's really, it's not you have to invest in the right people, and as I said, we have hired many people, and there's still more to come. The R&D team, we will be sharing more about the R&D moving forward.
We believe that Hikma is extremely well-positioned for CMO business, and we are in the process of recruiting, a head of CMO in addition to the CMO team we have. All these things will be working together to achieve, let me say, growth in the midterm to long term for the injectables.
James, just on the outlook for the Injectables business. We know that this is not something that we would like to be growing. It's. We have challenges at 2025, and this is something that we know that, and 2026. There are different reasons for this. It's, as I said in my presentation, is reduced CMO. One of our main customers want to do a domestic manufacturing in the U.S., so we have a reduced contribution from that. This is something that we cannot offer till we have Xellia up and running in 2028. We are less optimistic on, let's say, the biosimilar that we have, although it's a very small part of our business, and the liraglutide. One of the product launches, main product launches, has been pushed.
Of course, going forward, we are going to go back to return to very good growth for the injectable on top line and in terms of the EBIT. Any company, any business, goes into challenges. 25, 2026 was a challenging year. I think from here, from 2027, we are going to see a different outlook for the injectable business as we used to see in the past.
Just some examples. Of course, Sam, TYZAVAN is important product for us. That will drive some of the growth that we achieve this year. We expect that to do even better in 2027. That will be an important growth driver. Some of the products that we expected to launch this year pushed to next year. That will be, again, another growth driver for 2027. We've got, of course, continued expansion in Europe. That's been an important growth driver for us. That will continue. MENA has been also a good business. We signed six new biosimilars in MENA. There are a lot of opportunities to grow, you know, I think as Khalid said-
So-
This is sort of a reset year.
Yeah. Though the challenge is obviously, as you rightly point out with the injectables and what we're doing with it, I also like to remind everybody, this is a much bigger company than just the injectables, right? We have three very strong divisions, two of them that are doing extremely well. The MENA is growing, you know, at a very fast rate with very good margins. The Rx, as I said, has done much better than anybody anticipated two years ago.
If I told you we'd be doing 20% margins and with this kind of EBITDA, you know, people would, "Why did we keep on pushing you to sell it?" there will be a lot of focus, there will be a lot of investment, and we feel very, very strongly that in the medium to long term, this business it is already, in my opinion, one of the best businesses. If you compare our margins to our competitors yesterday, who upgraded from 18%-19%, we are way ahead of them. other competitors saying, "We want to be at 22% EBITDA," we are at 25% EBITDA. This is a very good business.
It's driven by three engines, as we said, the focus is on long-term thought and total profitability, growth in earnings per share, rather than just focusing. I think this is what really hurt us the last 2 years, the over-focus on the margins of the injectables, where people start saying, "Don't sell anything less than 32. Don't accept anything." If I can get $300 million worth of orders at-
There were opportunities.
... at 28%, I shouldn't take them. Of course, we need. That's why the focus will be on top-line growth and bottom-line growth rather than, margins.
If I may add a little bit about the, how we are going to, the, grow the injectable business moving forward. I don't know if you had the opportunity to listen to our presentation this morning, but I mean, we talked, I at least talked a lot about the ready-to-use platform. Even though, of course, the first product is TYZAVAN, as Susan mentioned, but we have multiple others in the pipeline. But those products, they will be launched probably in early 2028, so we will not see short-term, I mean, growth because of those products , but we have multiple products in the pipeline. I talked about, I think, 15 ready-to-use products in our pipeline. So of course, moving forward, we will see.
We will see the revenue, and we will see the growth from this platform, which I'm very excited about. I just to repeat Said, I think it's a really good business, so.
Well, there's other questions I could ask, but let someone else have a go.
We take... Yeah, yeah, let's take another question, please.
Seamus Brown, JP Morgan. Thanks for taking the questions. The first question will just be a follow-up on the previous answer in terms of what you described on the CMO challenges from one of your customers wanting to switch the manufacturing from Europe to the U.S. How do you see that risk going forward for the rest of the injectables, CMO business? Just broadly, how do you see the outlook for CMO overall from here? I know you've got the there's the small molecule contract in Rx, contributing this year and ramping next year. Just to remind us how you're seeing that outlook.
The first thing we did, we looked at our plants in the USA, for instance. We looked at the Cherry Hill plant and see what were the bottlenecks? What was needed? Many times, it's a small thing that you need to do to increase capacity. We're working on increasing capacity significantly at Cherry Hill. That will help us with the CMO business as more and more companies want to manufacture in the USA. Of course, we'll talk about the Rx later, CMO, because they already have a lot of orders and business. We acquired the Bedford site specifically for this, and it's a big site. It has a lot of equipment in it. It needs to be re-engineered in a more modern way. We're working on that diligently.
Sometimes new lines take a bit long to get. This, you know, you need to order them, it takes 1.5-2 years for the lines to be again. After they come in, you have to install, qualify, and get FDA approval. It's a bit of a long process, long-winded, that's why we're guiding to 2028. With most of the CMO, the big business, you get the order and the expectation is you deliver 2-3 years down the road. They don't expect to deliver tomorrow, because it's a process of moving products in and so on. That's why we feel very strongly about hiring a head of CMO, somebody that has already strong experience, has well good knowledge of the industry, and has good contacts with the companies that want to have CMO business.
We're very confident, like, in 2028 and forward, for the injectables, we'll have a very strong CMO business. For now, we will be showing that the Rx already has very strong CMO business. Overall, it will become a quite significant part of our business, let's say, 3 years down the road.
Very helpful. second question is on R&D. it increased to 5% to 6% of group sales. Are you now comfortable with that as a ratio in terms of thinking about that level going forward?
You ask me or you ask her? If you ask her, she says, "No, we need more." If you ask me, "It's enough.
When do we see payoff from those investments? 'Cause I know you've mentioned 2028 for the ready-to-use.
Mm
some of the increase in R&D last year, so just to talk to that.
Yeah, of course, we slightly increased the investment in R&D last year, but that was, I mean, really a slight increase. We also reorganized the R&D organization, so now we have a global R&D organization, and we also moved activity from U.S. into Croatia. Of course, that is clearly helping significantly on the injectable business, but we also have a very strong team focusing on inhalations, semi-solid, and liquids, in Columbus, in Ohio. Then, of course, our team in Jordan is focusing on solid oral. I strongly believe that we have the right team in place. Would I always like more money for R&D? Yes, of course, I would.
Said is correct there, but I feel very confident, though, with 5%-6% of the revenue being spent on R&D. I think that's just in line with what our competitors are doing.
Thank you.
We are going to see these returns coming into the coming years. Some of it will come in 2027, some of it will come in 2028 and 2029 onward.
Yeah. Yeah, of course. R&D takes time. Just so everyone knows that.
Yeah. You have a question.
Yeah. Up in the chair. Yeah. Thank you. Hi, Beatrice Fairbairn at Berenberg. Thank you for taking my questions. You discussed the focus on long-term growth. I mean, one of the targets out there is this kind of 5 billion 2030 revenue target. My question really, it was, does this still stand, and would you be able to give some color in terms of what is needed to get there and how that looks like over the coming years? Just on your delay to sort of the timing of some of the product launches and injectables, do you feel like the new timelines that you've got are realistic, and kind of how confident are you that you're gonna be able to launch these products on time?
I'll take this first part about the $5 billion.
$5 billion. The $5 billion, when we set the $5 billion target, we said that this was it was an aspirational target, but we felt that it was very achievable with the business plan that we had and our business model, which has been to do bolt-on acquisitions, you know, as a matter of course. We still do feel comfortable that $5 billion is within reach.
It's very achievable, yes.
You know, it's, it is, we definitely see an acceleration of growth after 2026. You know, I think today, it would require a bit of inorganic growth, but, yeah, it is very much within reach.
It's more an organic growth.
Yeah.
It's not like we are talking about a transformational, like more of a product acquisition. We are very close to the aspirational target of $5 billion. If you look into the three businesses, like the branded is delivering very good growth, acceleration. If you look into the past, it was 5%-6%. Today, we are doing more, 7%-8%. This is driving growth, high-value products that we are getting into the MENA region. If you look into the number of licensing deals that we've been signing over the past 5 years, it increased significantly, and now we are becoming more and more the partner of choice, so this is going to be a key driver. Rx is growing with the CMO business.
We are going to see more contribution coming in 2027, 2028, 2029. This is as well going to drive the growth. Injectable, of course, with all these RTUs and the products that we are working on, it's gonna accelerate the growth for the injectable business. Remember, the injectable business has a large portfolio. There will be always opportunities, there will always be shortages. Europe, we are seeing a very good growth, very good, great potential, especially that the market is lacking products.
I would say, most reliable hospital supplier in Europe now. All hospitals are coming to us, and governments coming to us say, "We want this product." The agility that we have in Europe, providing the products on time, is differentiating us versus others. This is why we've seen 23% growth this year in the injectable in Europe. Same for MENA. It's not just like the six biosimilars. We have many products that we have, that we are going to launch in MENA for biosimilar. This is going to be the growth driver, and we are very confident of our ability to continue growing the business. As said, 2025, 2026 might look challenging for the business, but this is a business cycle. From here we are going to continue growing.
The short answer is yes, the $5 billion is very achievable. We are extremely confident in our 2026 guidance. Yes, the injectable launches that we'll be seeing in 2028 and further will deliver the kind of growth that we need to be there.
Thibault Boutherin, Bank of America. Maybe just one question on Rx. That one seems to go pretty well, and it looks like you have, like, even some room in term of margin. You've been investing even, like, more than what you're using, actually investing for injectables. Can you discuss, like, the different moving parts this year? The base business, I think there might be some competition on, you know, on certain products. On the other, on the flip side, you have some, you know, service payment from your CMO partner. Are you expecting at some point to be able to update the market on, you know, who is that CMO? What kind of...
You know, what is the product, and what are the economics behind that? I mean, just like a bit more visibility on the CMO, because it's a huge moving part for Rx, for sure.
This year, the revenue from the CMO business will probably be around 10% of our business. Our target in 2030 is up to 20%, at least my target. We are not going to share the name of our customers, but we are, though, working with not only one big customer, but actually multiple. Some of them, we're talking about contracts which have not been signed, but are in negotiation phase, and we will be signing within the next, let's say next few months. That's going very well, and you also asked about the base business. For example, a product like Advair has been doing very well last year, and we expect the same this year.
Fluticasone, we are the biggest volume driver in U.S. for fluticasone, as an example, or for nasals. That is a business which continues to do very well. All our base business has been doing really well last year, and we haven't really seen any change, at least for the first two months of the year. It's more stable than maybe most people believe it is, so...
Thank you.
Can I, just remind people that we have Jon, who's the commercial head of injectables, on the line, and Mazen, Deputy CEO for MENA. Don't hesitate to address questions to them as well.
It's early for Jon, so you should really ask him questions now because he woke up very early for you.
Thanks. Christian Glennie with Stifel. Again, not to belabor the point, but on the injectables and the margin, just to be clear around. You know, it's been quite a dramatic shift, right? From mid-30s to high 20s now. There isn't something sort of. Well, couple of things. One is you talk about the extra investments, you know, needed. Implication potentially may be that you weren't, you were underinvested before to some extent, so the margin was sort of where it was that. Is that, is that fair? The second part is: Is there something more structural around the market, from a sort of pricing and competition issue that means margin has the direction of travel has gone?
Okay. First, first one, as I said, I mean, clearly, we said we're taking the R&D budgets out of the divisions and putting it as a corporate, clearly indicating that at some point, division heads were sort of reducing R&D expenditure to give higher margins. By taking that out and, and having it as a corporate with a fixed number that we agree on, I think that will... You know, there will be lower margins a little bit to start with, but we are very confident that with the investments we are making in R&D, the new pipeline, the expansion in the manufacturing, and the CMO, that we will be achieving higher margins mid to long term. Okay. The second question was?
Structural, something in the market. You know, 'cause you've got-
The mar-
You just-
Yeah, yeah.
Actually-
There's always competition. There's always people coming in. You lose a few products. We lost two or three products that were... Not lost, we have competition coming in, two or three products that were doing extremely well, and that's why when you have such a well-diversified portfolio, and you have so many products, other products can pick up, and the new launches can pick up. The market has always been competitive. It's always been, you know, competition is coming in. Do we feel that there's more competition? In some areas, yes, in some areas, no, but we're confident that with all the changes we're making, we are fine.
It's, it's not like structural change in the market.
Yeah.
It's the pricing is around, let's say, if we exclude the two top products that we have, it's 4% or almost less. Low to mid-single digit price erosion that we've seen in this business, so nothing is abnormal.
Maybe if I may add. I think, over the last few years, the supply from third party has increased significantly, and third party, of course, is not as profitable as if you're making the product internally. I think it has been going from 20%-30% over the last few years. That's, of course, affecting the profitability. Also, I mean, there are different part of the business which has higher profit than other parts. Of course, while you are building the business, injectable business in MENA, which is less profitable than-
Yes
The business in U.S. and in Europe, of course, that will affect the overall injectable profitability. That business has clearly been growing as well. Those are at least two reasons in addition to-
If you exclude MENA margins, both for the Europe and North America injectable business, the margin is north 30%.
Thanks. Maybe the natural follow-up is, I know you're probably reluctant to guide beyond kind of 2026, but, you know, just to get a sense for that margin and, you know, is 27%-28% the floor? Then maybe that's similar until you really get into Xellia, and then margins should improve, or is this, you know?
We're saying we're very comfortable that 28 and further margins improve. I think once we assess everything and we have a You know, we have the plan, the right plan in place, are we going to be giving-
May I take this one? In a way, we've guided to 27%-28%. I said in my presentation this morning, you can assume this is for the coming a few years. It's not like if we have an opportunity that is sub 30%, we are going to say no to it. We don't want to be strictly held on these margins because we are going to focus on growing the profits and the EPS, rather than just focusing on the margin, as Said mentioned. You can consider, like, this 27% for 28% to the next three years. What has changed, just repeating to what I said this morning, from the November when we set the floor is 30%, is literally increase investments in R&D.
We are increasing $15 million this year versus last year in injectable. You look into the investments that we are having, as Said mentioned, fitting in sales on marketing, so, and the CMO. This is why we are going down, like, 2 to 3 percentage point. It's not something structural in the business, but it's more investing for the future.
Just gonna jump to the line for a call quickly now, for a question.
If you would like to ask a question, please signal by pressing star and then one on your telephone keypad. We will pause for a moment to allow the questions to come in. Your first question comes from the line of Kane Sutcliffe of Deutsche Bank. Deutsche Numis, rather. Your line is now open.
Thank you. Thanks a lot. Morning, guys. Just, sorry, could you just clarify? I missed the last point on the higher R&D in the, in injectables. Could you just sort of clarify sort of those moving factors between higher R&D versus the lower CMO work, like in terms of which has moved the needle more there? I assume it's the R&D, but if you could just clarify that. Then just, you're obviously spending some time doing the strategic review. I'm just wondering, at what point do you think you will be able to sort of reinstate a, midterm or a new midterm guide? Then just finally on the buyback, just I guess, you know, why has it sort of taken so long to do it?
You know, could we, could we see a more permanent feature going forward if shares sort of remain where they are? Thank you.
I think I can maybe take the R&D question. If I could hear him correctly, I think he was asking for the spending for R&D. The overall increase in the spending for R&D this year compared to last year is around $45 million year-over-year. I think that was your question, but I'm not really.
Kane, could you just repeat the first question? Thanks.
Yeah, I was just wondering, sort of in that lower guide, how much of it is sort of the lower CMO work you referred to versus R&D, in terms of what's impacting the guide down?
Injectables margin guide-
Yeah.
How much is CMO going versus...
I-
Sorry. I think, Kane, it's more evenly split across R&D, sales and marketing, and CMO. I would say those are the three biggest factors, and they're of more or less the same magnitude.
The buyback, I agree with you, it's taking too long. We have taken the decision to do that $250 million this year.
In terms of the medium-term guide, yeah, I think we'll get back to you on that. We know that it's important for the market. We want to get it right, and so, yeah, I think.
We'll come back to you.
You know, we'll come back to you.
All right. Cool. Thank you.
Thank you. There are no further questions. I'd now like to hand the call back to the Hikma team.
Julie Simmons, Panmure Gordon. Just on a more product-specific basis, wondering with TYZAVAN, clearly, you've just launched it. It feels like the sort of momentum's pushed out a little bit to 2027. Are you noticing anything from the first sales in the market there?
Good morning, this is Jon. Yeah, maybe I'll have to address that.
You're on mute, Jon.
Nope, I am not on mute.
You can hear me now?
Now we can hear you.
Okay, great. Hey, good morning, everybody. We are in active launch mode for TYZAVAN. Let me just frame the market, because this is important to understand, because the RTU bag platform will follow a similar pattern. Vancomycin is a widely used product within the U.S. There's about 41 million grams of the product used in multiple forms, from a very lyophilized powder to a frozen bag, to obviously our ready-to-use bag. What we are selling is a system and a process change, which in large hospital systems, and large hospital groups, that by default, TYZAVAN would become the vancomycin of choice. It is really more of a process change. Now, put it in perspective, we have already converted 13% of the entire gram market with our existing vancomycin ready-to-use bag. We have a platform. We will expand that.
Within that network, there's about 22,000 sites of care that use vancomycin within the U.S., all forms, long-term care, hospitals, and such. Our existing customer base on the existing bag product represents about 15% of those sites. There is a very large universe of hospitals and health systems that have not used our historical bag. There is a large opportunity there. You have to think in terms of it as a process progression. We're gonna expand our existing base by expanding the usage of the product without restriction, and then we're also penetrating the customer bases that have not used our bag in the past.
Yes, this is going to be a progression into the back half of the year, the momentum that we're seeing right now is very active and very encouraging.
Thank you. Just following up on that from a sort of RTU perspective, longer term, do you think once a site is switched over to one RTU, it makes it easier to switching to another for a different product?
That's exactly why the way we're approaching this first one is extremely important. We wanna make sure we have the processes in place. You know, hospitals and groups, they have to reprogram medical, electronic medical record systems, infusion pumps, SOPs, ordering patterns, storage platforms, because you're bringing in a new form. As we work with TYZAVAN as the foundational product, we wanna make sure we fully integrate it properly. I do believe that that will help us going forward with the additional bags as they come to market.
Hey, Charlie here with Bank of America. First one's just, in our models, would it be reasonable to assume that I guess at this stage, a 30% midterm injectable margin is off the table, given focus on profitable growth? I'll get to the second one in a sec.
Yes.
The second one is just on the midterm guide, which obviously, since giving it, we've seen two cuts to... First is, I guess, talk me through the decision to issue the midterm guide, if there were some underlying concerns on the spending, the short-term focus to give that? Secondly, sort of, how can you reassure us and the market that this is sort of, you know, the last of the big cuts, and we're back to something profitable, you know, we can be return something growth from here?
Again, as I said before, it's not a complicated formula. You have the right people, you have the right equipment, you have the right facilities, you have the right R&D. All of these things, when you invest properly, you take timely decisions to take, you know, to move the business forward, this is the formula for success, and we've had this formula for 40 years. We sort of slowed down in decision-making and became too centralized. We were not investing properly in the right places, and now we're reversing that. That's why we feel very confident that, you know, at midterm, we will deliver what we're talking about.
2027 is gonna be, as well, a year that we'll see a growth. It's the bottom on the injectable, and from here, we are going to grow in top line and in bottom line. In addition to the other two businesses, they continue to grow, as I said earlier.
Just a third one, if I may. You talked, obviously, heavy investment the next 2 years. How confident are you that this is a 2-year journey of heavy investment, and that won't spill into 3 or 4 as the investments start continuing?
The investment is, it's not a short term. It will continue to be, but we will see we'll start seeing the results of what we're doing now, 2 years down the road and I believe further. When we look at our 5-year CapEx, our 5-year R&D, all this will continue to grow.
May I just to add to what Said just mentioned, in terms of the R&D, it takes time to see results, as Hafrún said. In terms of sales and marketing, these are quick wins. You invest today, it's not like going to take so much time till you get the returns, and this is what Jon is focusing on. You will have these investments, and at the same time, give you an example on the supply chain. Having somebody now focusing on the global supply chain would reduce our inventory levels. We will reduce the slow-moving items-
Failure to actions.
... which it was very big this year.
Failure to supply.
Failure to supply.
Yeah.
The immediate impact will be significant improvement to margins. This is why we are seeing that we are moving in the right direction. I think the results of this will come in the coming years, and we are confident about our medium-term outlook.
Thank you.
Hi, Christopher Richardson from Jefferies. A couple, if I may. You lowered CDMO or CMO expectations, sorry, for the year as some customers require domestic production, which you said you can't offer. I was just wondering if there were any reasons for that.
It's as we said, in Xellia, our Bedford acquisition is going to be up and running towards 2028. It's the same machinery, the same lines. It's replicate what we have in Portugal. Now, we couldn't offer because we don't have that facility up and running. Once we have that facility up and running, towards the end of 2027, early 2028, we'll be able to offer.
As I said, we, again, the Cherry Hill plant and the other plants, we looked at optimizing the capacity there, looking at the bottlenecks, bringing in the lines that are required to up the manufacturing capacity.
If I can add something about our Rx business, because we are only talking about injectables. As I mentioned, I mean, we have this huge, I mean, of course, manufacturing site in Ohio, both for solid orals, for nasals, for inhalations, and that site has been getting a lot of attraction over the last year or so, since all this discussion about domestic manufacturing started to happen in U.S. There's a lot of interest in us, in producing products for different clients. I think this is going to be a big opportunity for us moving forward, both in the Rx and also in the injectable business.
Many times, clients come in let's say, for the solid oral, then they feel very comfortable with you, and they open up and move injectables and other things to you, for you.
Great, thank you. Just the guide cut in November was due to equipment delays. I was just wondering what the situation is now and what caused you to walk away from 2027 and whether the timing for Bedford has changed at all?
It's no change to the guide that we had in late November. All what we said, that we are going to ramp up, start ramping up towards the end of 2027, and the commercialization will start 2028. No change to our plans.
Great. Maybe just a quick final one. I was wondering if you could comment on the oral generics pipeline and the margins in U.S. Rx, excluding any Xyrem impact.
Excluding, sorry?
The impact of Xyrem.
Xyrem.
Sodium oxybate. Okay, last year, Sodium oxybate was dragging down our profitability. The rest of the business was actually compensating for the low profit of that product. We managed to negotiate a better deal, at least for this year and for next year, so we will have slightly better profit of that product, but so it will not be dragging down the overall profit for the Rx business. Is it helping this year? It potentially will.
Wonderful. Thank you.
James?
Um-
What's it, Moro?
I'll go with one. Seamus Brown from Morgan. Thanks for the follow-up. On CMO, you mentioned you're looking for a new head of CMO.
Yes.
Just the characteristics you're looking for in a head of CMO, in terms of the type of the kind of the profile that you're looking at, and when we could expect the appointment? Does this mark a potential shift to making CMO like a fourth division? That we've sort of thought about in the past in terms of strategically, so integrating the Rx and injectables?
Historically, we're used to the CMO as a fill up. We thought, this is extra capacity, let's get, you know, products to fill it up. When we were approached, or we found a client to come in and use the Rx site, it was more of a long-term agreement. Long-term agreements require dedicated facilities, they require dedicated lines and sometimes dedicated teams, and it's a lot, you know, it's a lot of investment to do that, and it takes time to come in. It's a long term. This is what we want to do, not just, you know, bringing in short-term fixes. To do that, you need somebody that has been doing that for a very long time, that knows which companies require CMO business.
Also, I think more importantly, when you do the contract, when you're looking at, let's say, 5 billion tablets or something, half a cent per tablet extra gives you $50 million in profitability. Having the right negotiation skills, the right contracts, 'cause all these things. This is what we're looking at. We have this, but we think that getting a very senior person that has done this successfully is the right way to go. As I said, we are interviewing. There are several people out there that are available with this kind of talent.
Makes sense.
Yes, could be a fourth division. Very much so. Yes. One more.
Just quickly on the CMO headwind for 2026, was that one customer you lost that's gone from Europe to the U.S.?
Yeah.
I guess, how was that conversation, and how are conversations with the remaining customers to ensure that won't happen with someone else before the 2028?
It was one of our customers. It's not like they are shying away completely. They still have business with us, but they decided to... Some of the manufacturing for their own benefits, they wanted to have it in the U.S. It's not like the business is going down, it's to replace, it's going to take some time to get a new customer. We are confident of our ability to continue growing the CMO business. It's a matter of time, but when we have the Xellia, of course, up and running.
Yeah
We will have much more clients, much more capacity to offer as well.
There's a lot of demand for U.S. manufacturing. I think, you know, the Bedford acquisition and what we're doing now, although it's going to take a little time. Like I said, if you want to get a client that will work with you long term, anyway, it will take 2 years before you can move in the product. Now is the right time to get, you know, to get the clients and get the orders in, so you can put the processes in and do the submissions and all these things.
Tech transfers.
The tech transfers and so on. By 2028 and more, you'll be ready to launch. The demand is there, and we are talking to a lot of companies.
What they are saying is that if we would have had capacity in U.S. to take on those product in U.S., we could have probably potentially have kept that customer. We didn't have the capacity.
Yeah
At that time, so I think that's. Now we are building that, so moving forward, we will.
If you remember as well, when we did this acquisition, and we took the Bedford site on, it was because we were reasonably capacity constrained in our existing facilities, and so we weren't really very actively selling CMO business at the moment, because we're pretty much. You know, we don't have a lot of spare capacity for CMO without the Bedford site, so.
Okay, any more? Last question, I think. If that's okay.
Thanks, it's Christian Glennie. Thanks for the follow-up. Just maybe on Rx, and just a couple ones there. I think you've alluded to a couple of the things around the moving the margin to 20%. Just to clarify, the step up this year to 20, is the 20, again, another kind of a base for the business going forward, do you think? Just finally, on nasal epinephrine, what's the update there? and obviously, it's been delayed, what's the expectation around that? I think it had been seen as potentially quite a significant product for you, just an update there.
Maybe first on the margin. Is 20% the best we can do? No, I think probably, you will probably see some improvement moving forward as, I mean, in 2027, even 2028 as well. I'm not going to give you any numbers, but I think, I don't think that's necessarily the top of the, of the pie. With regards to epinephrine, as I think we talked about last time when we, when we had this conversation, there were some requirements from FDA to run some additional study. That study is ongoing, and we are planning to submit in U.S. in, let's say, after a few months now. We did file a product in U.K. last year.
We will be filing in Europe as well, and we are actively discussing out licensing the product in Europe. That's the update. Because we have been working so closely with FDA over the last year or so on the product, I strongly believe that the review time will potentially be shorter than maybe we thought in the beginning. It will be an exciting product for us.
Somebody ask Mazen a question about the MENA. He's bored.
There's only going to be one direction.
I can't even engineer to you. The question- Thank you. James from Barclays again. Just when we're talking about margins, and we're talking about generic margin and an injectable margin-
Rx. Rx.
Sorry, Rx, apologies. I've also heard that effectively, you're going to centralize R&D spend, and that we could think of the divisions as being a bit ex R&D. You're going to think about what their ex-R &D performance is. If we're rebuilding our models after today, is that how we should be thinking about Hikma now, and are you going to start giving us then what the margins are for these three divisions without R&D and then a central R&D line? What do we do with our models?
Eventually. This year, we did not want to-
Too much change for you.
... too much changes to.
Yeah
Changing your model. Eventually, next year, you will start seeing the margin without the R&D.
With and without.
With and without.
A bridge this year, and then we do our rebuild for next year?
Yeah.
Thank you.
I guess-
Mazen, I think it would be great, maybe... I think one of the strengths for the business in the MENA in the past year has been, all of the partnerships that we've signed. We have excellent momentum in terms of signing new partnerships. Maybe you could just talk a bit about why, Hikma seems to be the partner of choice in MENA.
You're on mute. Mazen, mute.
No, he's not. He's just very... The sound is very low.
No, try again.
He is on mute.
He has been working.
Looks like he's on.
Luckily, you didn't ask him any questions.
Okay, next question, till he comes back.
I think in the absence of Mazen being able to join, I, over to you, Said, for closing remarks at this point.
Sorry?
Closing remarks.
Well, again, it's first of all, it's good for me. I'm very happy to be back as CEO. I'm very happy to give up the chair position to be able to do this. We have an extremely good team. We work very well together. We have, I think, a very strong business. As we said, if you look at the last 5-year CAGRs and the years before, you've seen how this business continues to grow. We will continue to grow it. We are taking quick decisions. We are implementing a culture of quick decision-making. I also talked about the younger people in the company. For instance, from now on, the executive committees and the leadership council and so on, we will mix and match.
It will not only be on seniority, we will be having more younger people join. There is obviously something we didn't talk about, a lot of focus on AI and seeing how AI can be implemented to move the business forward. All in all, I feel very, very positive about this, you know, this is a strong company that has been growing for a very long time, has very solid foundation, has a strong leadership team, and a lot of talent across the board, and I am very confident that we will be delivering the kind of growth that we expect from ourselves and our shareholders expect from us.
Thank you.
Thank you, everyone. Appreciate you joining us. Thank you.
Thank you.
Thank you. Thanks, Jon. Thanks, Mazen.
Thank you, Jon.