Hikma Pharmaceuticals PLC (HIK) Earnings Call Transcript & Summary

Good morning, everyone. Just before I hand to Riad, we'd just 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 latest annual report. And with that, I'll hand over to our CEO, Riad Mishlawi.

Thank you very much. Good morning, everyone. Just for the very start, I would like to read a couple of paragraphs here. I think all of that was included in our announcement this morning. Despite what's happening in the world and despite some of the uncertainties that we have, we have a really -- we feel like we have an encouraging start of the year in all of our businesses. Injectables, we delivered a solid revenue performance with good demand of our products. We see it all across our geographies in Europe, MENA and North America. And we do see also, like usual, competition in some of our products. In this case, in this -- we are facing some competition on the higher marginal products in the U.S. And the Branded business is doing well, performing according to expectations. We're benefiting from our -- from the growth of our portfolio, especially in oncology and lifestyle disease products. Generic had a good start of the year, solid demand on our nasal and inhalation products. We've seen a significant increase there. I think the best news here is we're happy to reiterate our group guidance for 2025, reflecting our confidence in our strategic execution. We continue to expect the group revenue to grow in the range of 4% to 6%, for core operating profit to be in the range of $730 million to $770 million in 2025. Due to some of the phasing of our sales and the timing of the contract manufacturing opportunity as we had last year, contract manufacturing comes later in the year, one of the -- they are probably the highest marginal products that we produce, we expect the core operating profit growth to be weighted to the second half of the year, particularly in our Injectable business. From the strategic point of view, we have been launching new products across all of our markets. We're making excellent progress in enhancing our Bedford facility. As you know, Bedford facility, we wanted to revamp it. We've done great progress. We're accelerating. In fact, we're accelerating the construction -- the reconstruction of this facility and the [indiscernible] fill and what we need to do to get it in production. We're progressing well in our Columbus facility. As you know, Columbus facility with the CMO partnership that we've had, we're required to do a lot of expansion, the equipment, installation of equipment. In fact, that has increased to the originally agreed-on scope. And we think that there would be a lot more than we thought in this relationship. So we're very happy that this is progressing well. We continue to strengthen our pipeline and R&D and looking at investments in BD. And this, we really have been concentrating on. As you know, we got the Croatia facility from our last Xellia acquisition. We feel that this facility will offer us a lot. You see that the competencies that we've had inherited here, and we are now looking at enhancing this, adding to it a lot of people and trying to benefit from not only the Injectables side, but also from other divisions like -- especially, from the Injectables side. Last paragraph, I wanted to talk about tariffs. I know you have a lot of questions about tariffs, but I'll start with telling you that we don't know what you don't know. So however, though, I think one thing interesting about our company, and thanks to the founder of the company, we -- he believed that when we expand into any territory, we expand as locals. So if you see the number of plants that we have -- in MENA alone, we have 23 plants. Across the world, we have high 30s. I don't know how many we have now, but close to 40 plants across the world. We -- the philosophy was always you hire from within the country, you create the work from within the country, you create the relationship with the regulatory, with the government, and that eventually will give you an advantage. So we happen to be acting like this for a long, long time. So in the U.S., when we came to the U.S., I think we started buying facilities, significant facilities in the U.S. back in 2010 when we acquired the Cherry Hill facility. Everybody always thought that we are really against the current. Everybody was going to India. Well, we're coming to the U.S. We did the same when we bought Bedford. We did the same when we bought Columbus, and we did just now with Xellia. So our presence in the U.S. has been always the philosophy of the company. It's not a reaction to what's happening today. But it is definitely a benefit of what's happening today. If you say, I want to go back to the U.S., we're seeing all these articles right now. All the companies are saying, yes, I'm moving this many billion dollars in the U.S. We know how long it takes to build a plant, especially a pharmaceutical plant, get it approved, get it validated, test for all your products. It won't be less than 7 years. It's a lot. It's taking us 3, 4 years to refurbish a plant. So this is not an easy task. However, we are sitting on an advantage here because all -- most of our plants are in the U.S., and we are building Bedford facility right now. We'll hire 500, 600 people. And at peak, it has 1,000 employees. It has technologies. It has robotics. It has all what we need. And when we are building something now, we are, of course, using the latest technology that is available. So that is ongoing. We accelerated that due to what's happening today. We think we can probably get it a little bit faster. There's a demand on a lot of contract manufacturing that, I think, we can capitalize on right now. People are knocking on our doors for the Columbus facility, for the Cherry Hill facility and for this facility. So we feel that this is a great advantage in the future. But again, it didn't come as a reaction. It has been there for a while, and that's why we have an advantage of the timing if you compare it to a lot of our peers. So from the tariff point of view, we do have very low -- very small amount of API and finished goods that comes from China. It has always been U.S. -- a lot of it is U.S. based. All of our materials come from the U.S. Some come from Europe. Some come from China, but very little. We think maybe it's less than 5% of the group COGS that come from China. So dependency on China is not much. However, the situation that's happening right now is not only about how much money you are paying for the tariff. This uncertainty makes the supply chain, makes your inventory management, makes your vendors, everybody uneasy and not very smooth in forecasting. And you know this business is all about forecasting. If you're good in the supply chain here, you are a winner. It's not only about how much you pay. It's about how fast you can get it. You have the material when you need it, you're delivering the product at the right time. And we are afraid that these are the things that will be impacted the most, not only by us, but also by our vendors, by our people that we buy from. Vendors don't know. Are they going to get the order? How much is the order going to be? Is it going to be 20%? Is it going to be 30%? Is it going to be 100%, 145%? We heard yesterday that the administration now is changing their mind on China altogether. So how is that going to affect us? So we really don't know. However, we do know that it's not -- we are not the only ones that are affected, and we are sitting on an advantage compared to a lot of the people that are in the same industry. So that's what I have to say, and we're open for questions.

James Gordon from JPMorgan. Maybe one on tariff and one on Injectables before we get sort of bogged down on tariffs. So on Injectables, you're calling out more H2 versus H1 weighted on both revenues and EBIT for the year. But was that anticipated as much at the beginning of the year? I don't think it was as anticipated. And assuming not, what is it that's made it become more H2 weighted? Is it more the competition? And which products, particularly, you see more competition on? And maybe I'll pause there and then ask the tariff question.

Sure. So I think it was anticipated, but you're right. It wasn't as much anticipated as now. We have 2 big products with very high margins, namely testosterone and calcitonin. Those, we found 2 entries in each actually added to the market. And as you know, in the U.S. market, you have to make a decision when a new entry come and cut your price. You either match that price or you get out. There's a lot of -- so this is -- these are very hard decisions, and I give it to the commercial team that they have to make those decisions day in, day out because you can destroy the product and destroy the profitability or you can decrease your market share. Every decision had to be weighed depending on where we are, who the customer is and how much money I was talking about. But we have seen competition, and we are reacting to competition. Of course, this happens daily. It just happened to be 2 at the same time with the biggest products that we -- margin products that we have. So of course, we react. We look at other products to see how we are going to smooth it out. We have a plan of what we need to do. So we feel that our reaction is not -- it is going to be something that we have to do something about, but there's nothing outside of the usual competition that comes in and comes out.

And at the same time, the contract manufacturing, it was anticipated that it's going to be like more second half weighted. So it's part of -- like high-margin contract manufacturing will come in the second half. So it was like a demand from our customers that, okay, if you can push and delay contract manufacturing to the second half.

We usually like that. If you look at last year, it is always -- contract manufacturing was always put to the last thing. You need to get our products out, put it in the warehouse. So you have to manage the demand. So you use your facility early on for your own products. You let contract manufacturing at a time when you are really very -- your warehouses and your supply chain is all stable. As you know, in December of last year, we had a very big month. So that empties a lot of inventory. So when you come in the next year, you really want to fill that inventory. So you put your contract manufacturing later on. You concentrate on your own products. So that's also why contract manufacturing usually is pushed to the end of the year. But of course, contract manufacturing orders are set. It's take-or-pay. We're not worried about losing them. It's just a matter of when we are producing, but that comes to the coordination with our customers, of course.

And do you have a view roughly what the phasing will be on revenues and EBIT for the year, as in what proportion could be first half, second half?

We are not yet giving any guidance on that, but it's going to be second half weighted, probably similar to last year.

And the tariff question was just so you hopefully made comments about your high level of U.S. manufacturing, which seems like a big competitive advantage. When you talk about manufacturing, there's like raw materials. Then there's APIs. Then there's fill/finish. And so I think you do -- maybe if you could elaborate what you mean by manufacturing? And how much of, say, your overall U.S. COGS is attributed to the bit that you do versus the bit that you buy from someone else because people are struggling a bit to say, is all of the API like the COGS? Or is actually most of the COGS cost actually the other stuff you are doing in the U.S.?

Yes. So to be honest with you, we're still kind of put these numbers together. But what we can tell you is that it's not a big number. So COGS usually includes API. [ This includes your ] RPM, basically, raw and packaging material, which is your excipients, your API, your packaging material, your glass, your stoppers, your bottles. All of that is included in your RPM. A lot of it comes from the U.S. The key here, a lot of -- I mean more like 85% of the $2 billion, just about of revenue that we have in the U.S. comes from the U.S. The thing that we have to go is a little bit deeper now. So what is really comes from the U.S., we buy from brokers from the U.S., but it's coming eventually from China. So how is the broker is going to react? This is all unclear right now. But we know that directly, what we get from China directly and we source is less than 5% of the group -- of our COGS, which is very, very minimal. We have finished goods like liraglutide, for example, that is coming from China. And that's also, I would say, also -- do we have a percentage? Is that what...

Like raw material is very little, but you have some finished goods that you buy liraglutide and some other products from China, but it's not going to be like -- it's not significant out of the total. So it's like 5% of the total cost of goods sold of the group, which is, let's say, it's 100-something million.

We have paid tariffs on some products that we get. We started already paid, and the last shipment that we had, we had paid some tariffs. The thing about it and the thing that is uneasy is we don't know how much it is. We wait until our broker bills us. So the last one was 20%. So...

And you don't know, and this is still like in the negotiation, how much you could pass to your supplier, how much you could pass to your customers. So the situation is very evolving. It will have an impact in the short term. But long term, as Riad mentioned, we are in a much better position than many of our peers because we can benefit from that. But it's not going to be the total impact on tariffs on just the manufacturers because many companies are going to increase prices. You can share the cost with your supplier. Still, it's an evolving situation.

Yes. But manufacturing in the U.S. is an important factor because if you think about it, usually, your COGS, your RPM is maybe, in the Injectables, much less than the Generics, but I would say between 17% and 25% to 30%, depending, of course, on the product. So if you -- if there's tariff that you are going to pay for that, that would be affected, of course. But it would be very, very different than paying for the 100% of what you're getting as the finished goods. And we know a lot of competition in the U.S. A lot of our competitors, they get a lot more -- they don't manufacture in the U.S. They get a lot more than just the 17% or the 20% of RPM with that. I think there would be a chaos in the beginning, right, as we see it now. But would that be an opportunity for us? I think this is something that we are -- we think that it would be because in contracts with the GPO, you can say, look, there's a situation that I could not control, and I want to get out of that contract. And you can. It's something that's out of your control. You can say, I want to -- you can't come and say, I want to raise the price. Many of them, or the GPOs, will not accept you just go raising the price. What they will say is we'll rebid it. You can get out. We'll rebid this item, and all your competitors will come in. Would that be an opportunity for you to raise the price? And everybody else will raise the price because would they -- would that be an opportunity for them to pass that tariff to the suppliers? It's something that we're watching very closely. I don't know. But I think we are -- we would probably have some opportunities there that we would be able to be sitting in a better situation than others.

I'll pass the mic. I guess just a final one. Can generics companies in the U.S. pass on most or all of the tariff impact as price? Or is that...

If they all act together. In the beginning, it's going to be chaos because it depends now how much inventory do you have. I might not have any inventory. So the tariff is going to start now when I'm bringing some products in. Another person would have 2 years of inventory, can afford it without having it. So in the beginning, until it kind of settles and stabilizes, it's just going to be chaotic. But eventually, it will settle, and things will become more clear.

Seb Jantet with Panmure Liberum. Two questions. If I just go back to Injectables and the 2 products that you talked where you've seen some new entrants come in. So what have you actually done with those products? Have you lowered the price? Or have you kind of reduced your volumes? I'm just trying to understand the impact. And linked into that, what are you planning in the second half to recover the lost margins from those products?

So what you do is different from one contract to the other. Some you might -- depending on the volume, depending on the importance of the customer, depending on if you want to lose it, depending on how much are they asking you to lower. In some cases, you do lower. In some case, you choose not to lower and lose some market share. At the end, the results might be the same, but you have a product. You might sometimes destroy the product at a point where there's no margins at all, or you can preserve some of that margin, just have to give up some of your market share. This happens every day in our industry. We have 175 products in the U.S. We're the second or the third largest portfolio in the U.S. And we see this competition come and go. You have to hold your breath to see what happens. You'll learn more about your competition. You'll learn about their costs. You'll learn about what they can afford, how aggressive they are. All these factors are going to determine how you act at the end. So there's not really a set formula. It's just something that you will have to assess and see. And in the meantime, you have other products that you have to work on. You might increase your volumes to make up for some of the margins. You might concentrate on some of the higher marginal products to see if you can push for more market share. It's not unusual that this thing happens. The only thing I would say is testosterone in particular, we have been operating with 6 other competitors in the same market. And we have been -- we stabilized that price or that -- the margins on that product for a while now for, I would say, 12, 13 years. This is unusual. But then when we become 8 and somebody is a lot more anxious and then you can lose control. But it's still a product that is holding value because it's difficult product. It's an oil-based product. It's hard to manufacture. It's a hormonal product, so you have to have a special part, a special way of doing it. Although it's -- there's a lot of competition there, but it is not an easy one where you really can just set it for a lot less. The margins are always high on that one.

And then I guess more of a strategic question. So your long U.S. manufacturing facilities, which is clearly a good thing right now. I guess you've got a choice here as to whether you kind of make those facilities available to others for contract manufacturing or whether you try and use your strength in terms of U.S. manufacturing facilities to go and win market share. So where strategically are you thinking you're going to go with that -- in that?

We will do both. I think our capacity that we're bringing online -- well, first of all, I think this is a very important question because you have to go beyond the first quarter and the first half and look a little bit beyond what -- the future, what we have. We have a lot of confidence in the Injectables, especially in the Injectables. And I'll tell you why. The first thing is we are bringing in not only more capacity, but very needed capacity. We have 6 facilities that will have 6 huge lyos and 3 injectable lines that will be feeding those lyos that will be online. The lyos usually are used for very high-value products, delicate products, biosimilars are used. Most of them are lyophilized. A lot of the delicate products use lyophilization, and there's always need for lyophilization. Lyophilization is a very capital intensive. Lyo -- a typical lyo costs between $5 million to $7 million. But it's not only the money that you need, but also the installation, the validation, which takes a long time. So getting into the lyo industry is a very long-termer and a huge capital investment. We are going to put a huge number of lyos, and we are in the process of doing that. The lyos are in place. We are now installing automatic loading, so all robotics. The products will go into the lyo and out of the lyo without any human intervention. That's what we're doing today. That's what we're changing from what we had bought. We bought manual operations, but we cannot -- we don't like manual operation for reasons for quality, of course, quality reasons. Machines don't make mistakes. Humans do. So we try to concentrate on robotics and because of the efficiency. So that's one. And the second one is an aseptic bag filling plant. And this is a technology that is very, very unique. It's usually the likes of Baxter and Braun are the ones that have this technology. We think we have this -- or this technology is going to help us, especially with the new product that we acquired from Xellia, which is the Vanco Ready. The Vanco Ready is a product that we're also looking for the future to be a big product. We believe that the black box will be removed, and we will have a big branded product that is needed. Right now, vancomycin that is being used in a lot of the hospitals is being compounded. The compounded product is only good for a very short-time expiration date. We will have a long-time, NDA-approved product that will be done. So we're excited about this product. So I think what's coming to the Injectables in the long -- in the medium term, there's a lot more opportunities for us to continue with the growth, to continue giving good higher margins and to feed the Injectables exactly what it needs. We'll have some contract manufacturing, of course, but we'll have also a lot of our own unique products manufactured in those facilities. Does that answer your question?

Yes.

Al Campbell from RBC. Just a couple, please. Just on inventory, I mean, ahead of the potential chaos ahead, are you working towards increasing your inventory levels of intermediates across the business? And should we be thinking about that in terms of working capital? And then maybe just a top-level view on broad capacity in the U.S. Can you sort of give us a feel for if you were to pull the levers, how much additional capacity you could get in the U.S. to manufacture both generics and injectables over like maybe a 1- to 2-year horizon?

Yes. I will answer part of the question. I'll leave it to Khalid to talk about inventory. But I will say that Khalid has been always trying to control the inventory despite our businesspeople that try to be a lot more generous than we want us to be.

And adding to this, if you look into our inventory, it's the inventory base that we have today is like higher than our peers. And this is why I always push with the management, you have to reduce. However, now...

During COVID. We always remind him during COVID times, we've had one of the best years that we've had. And it is because of the inventory. It is because of inventory management. So there's a cost of carrying more inventory than you need, but there are advantages. Especially, we pride ourselves, and we are very careful in being delivering on time, trying to not -- try to be very reliable supplier. And that sometimes have to do with the cost, and the cost is mainly the inventory. So we do have healthy inventory in most items that we have. So I think we'll ride that uncertainty for a while before we start restocking our inventory. But again, you still need, of course, buying inventory daily. But for the imported items, a lot of it is already in our warehouses.

So in like times like this time, COVID times, having higher inventory is beneficial as well.

Yes. On capacity, we have a huge amount of capacity. So we are very happy, and I hope that all of you will come to see our plants in Columbus. And you should if you're trying to still thinking about it because we want to show you what we have. And Columbus is a good example of the facilities that we've had. We have -- so Hikma, the reason why I think Hikma has been successful and has been making margins the way that we were making margins is starting with the plant. We manufacture a lot of our products ourselves. Our plants are always -- we spend 6% of our revenue in capital expenditure. A lot of it has to do with always renovating our facilities, adding more and more equipment, investing in robotics and automation. And this is something I would like to show you because these are very, very important for you to see how we are able to increase capacities the way we are, what our plants are made of and the automation or the level of automation that we have. So to answer your question, in the last 14 years, we -- since we bought Cherry Hills from Baxter Healthcare, and I personally was there for a while. I was living and managing that plant. We had built a plant within that plant, and now we are decommissioning the old plant. So we have completely all new lines. And the lines that we have are lines that run at 600 a minute, and they are all robotic. They have automatic weighing systems where you weigh the vial before you -- 100% verification of weight. So we have a lot of sophistication when it comes to our equipment. We invested a lot in the Cherry Hill facility. So Cherry Hill facility, I would say, has a capacity anywhere between 250 million vials to 400 million vials depending if you want to work over time, if you want to work 7 days a week, if you want to work 7 shifts, if you are doing the small vials, the big vials, all of that really depending on what capacity you have. But you have huge capacity in that facility. We have 12 lines, and 7 of those lines are very, very new and runs at extremely fast. And we have one line that is on order that is also coming to Cherry Hill facility. The facility that we're building right now, the Xellia facility, we have 3 lines of 600 a minute, 6 lyos, 2 lines of aseptic bags fully automated. Everything is robotic, all the bags and automatic loading and all of that. So this, I would say, you would be able to make maybe 30 million to 50 million of lyophilized products depending on the size of the vial. And in our Columbus facility, this is something also you would have a chance to see if you're coming. There's a lot of investment, I would say, around $300 million investment that we're doing today of expanding the facility. A lot of it directly related to our contract manufacturing clients that we have. We are preparing a big part of the facility for the contract that we have. And we are adding also new lines, especially in liquid and in nasal.

But we are not paying for it, anyway.

No, we're not paying for it.

But it's all part of our contract.

But, of course, it is our facility. So the capacity that we have, I think we are doing now about 7 billion units, and our capacity is probably double that. And of course, you always can increase the capacity if you're running 7 days a week, if you -- depending on the volume on the product.

I just want to add to what Riad just mentioned. We've been always investing around 5% to 6%, almost 6% of our revenue in CapEx. And half of it is replacement maintenance, and half of it is expansion. So this is across -- whether in the group or in the U.S., in the MENA, U.S. or Europe. So always, we are expanding. Every year, you have something that we are expanding the capacity. So it's an ongoing process.

James Vane-Tempest from Jefferies. Two questions. I think you said that 85% of your U.S. business is sourced -- excuse me, I'm afraid. 85% of your business is sourced within the U.S. Are you able to help us understand perhaps between injectables and orals? Because I know a few years ago, I think you realigned various capacity between Portugal and Cherry Hill to kind of get scale, and there's maybe some supply coming out of MENA into the U.S. So that would be helpful to understand. And I've got a question on R&D as well.

We can give you estimates. We are still trying to sort things out and trying to get accurate numbers, but to give you somehow. I would say 75% of our total revenue that comes -- that we make in the U.S. is made in the U.S. It's manufactured in the U.S. The rest of it is manufactured outside of the U.S., but it could be in our own facilities that Portugal, for example, does a lot of complicated products, bioproducts, oil products, antibiotics, all of that for the injectable unit. Some we get from third party, very little. We did talk about that number. But a lot of it, I think, is in intercompany made outside of the U.S. and brought into the U.S. Today, it's tariff free. It will not be impacted. It's coming from Europe. Some small number is coming from Jordan. But most of it is what Portugal sends to the U.S. in Injectables. Most of the Generics, over 90%, I would say, even 95%, we'll try to find that exact number, is made in the U.S. and sold in the U.S. So it's not sold from anywhere else. Some of the products, antibiotics that we have come from Jordan for the Generics and in the Injectables. A lot of the Portuguese products go to the Injectables.

That's helpful. And then my second question is on R&D. We've had various kind of questions about -- maybe some clarification. The 20% increase this year, how much of that is in Injectables? How much of that is in the U.S. business? Is there a bit of unallocated R&D if there's a building, which is being used for kind of both the segments? Are you able to kind of break down the overall increase of R&D by segment for us or at least qualitatively?

It's mostly going to be like for both segments, but more on the Generics side. I would say that probably the level of investments that we have today on the Injectables maybe is intensive, but because we have like now the Croatia facility, which is a lower cost than what we have in the U.S. is maybe you would not see the level of investment since cost is high relative to the U.S. But as well, as Riad mentioned, we are as well benefiting and leveraging from as well the Croatia center for the generic, and this is our plan.

I think we've been talking about R&D for a while. And I think we want to make that point that we really think R&D is important. And we want to invest in R&D, and we want to be a super R&D company. However, we cannot do it all at once. We have to do it smartly. It's not about how much you spend. It's about the effectiveness of spending. It's about the output that you put. And that's what we need to concentrate on. We have been visiting a lot of companies that we think we can have do partnerships that we don't have to start R&D from 0. We can start R&D from maybe 50 and take it to 100. There is a lot -- there are a lot of growth opportunities. But as Khalid said, the fact that we have also a big R&D center in Croatia, the fact that we have good talent in Croatia and we can recruit more, I think we can do more with less. And that's the idea. The idea is not only spending more, which we will be, but also be more effective and increase our output. In Generics, particularly, we have to do studies that we cannot avoid the cost. So you can do it in India, or you can do it in Canada, or you can do it anywhere in between. The cost is going to be significant. Especially if we talk about epinephrine, for example, nasal epinephrine, it requires 3 studies that each one is extremely expensive. So you need to spend money no matter what you need to do. In the Injectables, less studies, a lot more has to do with completing the projects, the API price of the project of what you're doing and the success rate that you have. But we really feel that we are just starting to accelerate our R&D and focus on our R&D. I think we will see that result in the next -- in the coming years. But we are more and more believers that to survive, we need to add interesting products. To keep the margins up, we need to make them ourselves. We need to manufacture them ourselves. We can always go and buy, but you'll see -- we will show you some of the -- the reason why we have some of the lower margins that we have is because we have products that are very interesting and very good, but we have to share the margins with the partner. And we are not going to keep the 30%, 35% that we usually keep in Injectables if you are going to share your margins. So you have to make that choice. You have to do both. You cannot only rely on partnership with interesting products. You have to do it yourself as well.

Just to clarify then to make sure I understood. The 20% increase, more in Generics and Injectables and not in corporate? Okay.

I've got 3 questions, please. Firstly, do you know where the competitors are manufacturing their testosterone and calcitonin? And could this be sort of a fairly temporary competitive impact? Sort of similar question really, but on biosimilars, I mean where are most of biosimilars made? And is that a real opportunity for your new Bedford site? And then I've got one follow-up.

I'll start with the second one. I think the second one is a good point. We have -- some already had asked us if we have -- if we will have some capacity to do 100 manufacturing of biosimilars in our site in the U.S. So this is a very good possibility. Of course, we'll have to weigh it out and see which is the best partner. Today, we already have a partner that we manufacture biosimilars for in Portugal. But I think whoever sells in the U.S. would like to be manufactured in the U.S., and the opportunity is there. So definitely, I think we'll have some. Where our partners or where our competitors manufacture the drugs, it's hard to tell. We can guess because we know them, so we can guess. And I don't think they are in the U.S. But again, it's hard to say. It's just a guess like anybody else.

Okay. And then finally, if more of your competitors have got to raise their manufacturing game in the U.S., are you expecting there might be sort of shortage opportunities, market share opportunities in ex U.S. markets?

Because they're manufacturing in the U.S. now?

If others have got to focus more on the U.S. with their kind of manufacturing capacity, could opportunities present elsewhere?

I mean, of course, there are always opportunities. We are global companies. And if you look at our MENA and if you look at our European sales, they're increasing significantly. So we do have Injectables globally doing very well. Of course, our MENA business, the Branded business is doing really good. I think the thinking right now is with the Generics, some of the products that we're making in the Generics can go to Europe. I think that's an evaluation that we're doing, especially with the interesting products that are coming soon. So do we expand our presence outside of the U.S.? It's always a possibility, and we're weighing it and evaluating it every day. So yes, opportunity -- there's always opportunities.

Christian Glennie with Stifel. Maybe just one on liraglutide and how you think that's performed according to expectations. I think you're still the only generic in the market, got about a 30% share unless there are new ones coming.

Yes, somebody came in a couple of weeks ago.

A couple of weeks ago, okay. Has there -- I mean has that largely performed as expected? Would there not be potentially been some benefit? I don't know what the economics are. Particularly, you might assume that it's a decent-margin product that may have helped to offset some of the other margin issues you're calling out in the first half. Just some commentary around.

Yes. I think liraglutide has been a great surprise for us that we were the only one for 2, 3 months. Somebody had entered the market. The product is made in China for the other company. We know that for sure. So it's a similar situation that we have. However, we did negotiate the RPM or the finished goods significantly in the last 3 weeks. We think it still will be a healthy product. But I can tell you why we are optimistic still for liraglutide. In the last month, in the last few weeks, the FDA and the regulatory bodies of the U.S., they are prohibiting compounding of semaglutide. Semaglutide, many, many people have had semaglutide compounded. Because of the shortages, you can compound the product as per the law in the U.S. Well, now Novo is saying there's no shortage anymore. So you cannot compound the product. And they're really trying to regulate right now. So they are not compounding -- from what I understand, the compounding of semaglutide has been very much decreased to the level that used to be just 2, 3 months ago, which means that the people that are -- that have been used to paying low cost for this drug, now they're going to pay the full price coming from Novo, especially that a lot of the insurance companies don't cover the weight loss indication. So that's what we think that a lot will probably switch to the liraglutide, which is a lot cheaper. Especially now with the competition that are coming in, it's even cheaper than it was just a month ago. So we believe that although the price might be less, the fact that we negotiated significantly a reduction in what we already buy, plus we think that the market share is -- the market is going to expand, we think we still have a good chance of keeping this product as a very valuable one.

And potentially that therefore some of your confidence around that margin improving in the second half. Is that a relevant factor?

It's really depends. Right now, you have one competitor. There are 8 applicants. So we have 3 on the market today. So how many is -- by the time it gets to 6, it will be very, very difficult now to be a higher-margin product, especially if you are sharing some of the margins with a third party. But if it stays, I would say, 4, 5, manageable, and you can still extract a lot of value. But we believe it's not -- it's still an important product.

And then maybe just we've talked about phasing in Injectables. Maybe just to confirm what you're thinking at the moment in terms of phasing on both Branded, normally typically first half weighted, and then Generics. I'm not sure where the phasing sits in Generics.

Last year, Branded was first half, let's say, weighted. This year, it's probably, I would say, 50-50. Like some of the oncology will come in the second half rather than in the first half oncology sales. Generics, it depends. But I would say similar trends that we have seen last year even.

More evenly distributed.

More evenly distributed.

Sorry, I just wanted to clarify.

Effectively, for the group overall, it's going to be more second half weighted [indiscernible], so across each of the 3 divisions, and then because of the very strong H1 across all 3 divisions last year.

Maybe one final one, if I can. I mean last time we sat here that you seem reasonably -- we touched on some of these topics, but you seem pretty confident around getting some new CMO, some contract -- winning some new business. You've got a lot of people -- more people out there now doing BD. Just maybe a sense of, obviously, things that should be moving in your favor in terms of demand for your capacity. What are you expecting in terms of potential?

Yes. If we talk about the Generics, we've had a lot that are coming our way. We are very careful, though. We need to be successful in what we're doing with this contract that we have. It's a significant contract. It's something that we need to be successful at, and we think the potential is going to be huge. So although we are weighing and we are evaluating other customers that are coming to us, we're very careful that our focus is going to be on completing what we have today. We still have a year to go of intensive construction and adding equipment. In the meantime, I think we are looking at 2 or 3 other potentials to add to what we have. So that's on the Generics side. From the Injectables side, we can't take any more contract manufacturing until we have our Xellia facility. We are evaluating customers. The good thing about the Xellia acquisition is the lyos and the lines that are in Xellia that will be in Cleveland and Bedford are the same exact ones that we have in Portugal. So that is going to help because if we are going to have a customer, for example, that want contract manufacturing, we can start doing validation in Portugal, and it will be seamless in the transfer because it's the same lyos, the same size, same bag size, same line, same filling, same automation. So it will be very easy for us to technically transfer from one end to the other. So this is one of these options that we have. But yes, today, I would love to take more contract manufacturing customers, but we will hurt our business. And if you hurt your business, it's hard to come back to it. We tried that in the past where we said, oh, it's an opportunity, let's get into contract manufacturing. But then when the contract manufacturing winds down, then it's very hard for you to pick your business. So you end up hurting your business. So you need to balance, and you need to make sure when you do one and when you do the other.

Vicky Lambert with Berenberg. I had a couple of questions. One on the announcement for the acquisition of the ANDA for trametinib. What is the kind of drug expect to contribute? And like how should we expect this to be a growth driver in the future? And then the other one was kind of just checking in again about the U.S. biosimilars, wondering if you could provide an update on that. And yes, when should we -- what sort of ramp-up should we expect for the product once approved?

Yes, a couple of comments on the product. It's not until 2031 that will be out. We will be -- it's an opportunity to be the first in the market. We think there's a value to it. We don't know -- it all depends -- just being first on the market, it's all depending on the strategy of the brand that you have. So some of the brands do authorized generic like what happened with liraglutide. They try to stuff the inventory to try to prevent you coming in and some just leave it go, they give it up -- knowing that the patent is off, they concentrate on something else and let you come in as the first generic and have the exclusivity. And it all depends on how it will happen. It's too early to say exactly what the forecast is going to be. All we can say is a good product, is very healthy. Being in the market and having the exclusivity of 6 months in the very beginning is something that would be very, very valuable. These are the type of opportunities. Some will give you a lot more return than others, but we just need to do a lot of them and hopefully that. But I think it's definitely a great opportunity. Anything you want to add, Susan or...

No, I think that's perfect.

And for the biosimilars, we expect -- I think they are submitting this quarter, right? This quarter, next quarter, something like that. I think the expectation -- yes, shortly. Expectation is towards the end of next year that we should have approval.

James again. A question just on the meet management event for Generics, I think, a bit, on Injectables. I'm not asking you to give us any information before the event, but just to set expectations of what are you going to tell us? Are you going to give us like a Generics guide? And could it be a revenue guide or an EBIT guide? How much visibility do you have now with Generics to be able to give guidance on that division?

More than you have today, I think. I think we are trying to put things together, something that we're trying to change certain things. I'll leave it to Susan to answer a little bit more. But I think we want to -- first, we want you to trust the future. So we want to give you a lot more visibility to what we're doing and how the future -- how we see the future. I think we want you to trust the medium term. We want you to not only give you numbers, but we want you to see it, to see what we're doing. And this is why we're inviting you also to go to Cleveland to see -- we'll keep talking about that facility in Cleveland. So I think with your own eyes, you can see how we're progressing. And that, I think we will reinforce it with some numbers, some outlook that we see ourselves. We also have some strategic changes that we would like to also announce, and I'll leave the rest to Susan to talk about it.

I don't think we can say more than that. The format is similar to Morocco. So we have the management team from Generics and Injectables who will be there. As we have said, the key is to meet them to get a deeper understanding of what we're trying to achieve over the medium term. And we are very comfort that you will be impressed with the team and the facilities that we have.

Maybe just as a follow-up, could it be that you talk about the group? Or is it really just Generics is the focus that you're going to be talking about in [indiscernible].

Generics.

And Injectables.

[Operator Instructions] We have a question from Miles Dixon of Peel Hunt.

And forgive me, I couldn't hear all of the Q&A. So I hope I'm not going over our ground. But could I ask you more broadly about Generics, in particular, in the U.S. So around tariffs, I mean, for instance, if there were to be more punitive tariffs that come down, especially given the lower margin and accepting the inventory build that you've already talked about, how long do you think it might be before the U.S. patient or consumer feels any potential changes from those tariffs?

Very hard to say. Well, thanks for your question, first of all. But I think you're touching on the uncertainty that we're all feeling today. So some are predictable, some, I think, wouldn't be predictable. You know that if the manufacturers or if the brokers and distributors are affected, then there's 2 choices. They can either take that extra cost themselves, or they are going to pass it to the customers. And that happens in different mechanisms, rebidding the contracts, getting out of contracts and being aggressively after contracts. So what I'm trying to say is that there are a lot that is going to happen until things are settled. The base price or the base cost of certain products might change. And that eventually somebody has to absorb it. Whether the customer is going to absorb it or the manufacturer is going to absorb it, it really depends on the level of margins that you have, on the product that you have, on the number of competitors that are out there, on where the product is sourced from. We know that China is -- manufactures a lot of the starting material, if not the API itself. So you could get the material from India, but the sourcing and starting material is from China. We could get material that is made and we buy it from the U.S., but the source is also somewhere else. All that is not clear right now. The other thing that is not clear that is really making us a little bit, I wouldn't say uneasy, but I would say curious to see how is it going to be calculated is the fact that if we have made a product in Portugal using Chinese material, is that going to be subject to tariffs or not. Today, we've heard some consultants that we've been contacting a lot and talking to a lot of experts in the area. They are confused themselves, but they told us that you have to transform the product significantly for you not to consider it as a Chinese if you use the material. But what does transformation mean? To what level? What is significant? And all these are subjective words that until now, there's no definition to.

And adding to what just Riad said, like some advisers are saying the expectation that there will be inflation on the products even that you buy in the U.S. So they started with 1.8%, then 2.2%, then now 2.7%. So still every week, you see different kind of news coming, what kind of impact it's going to have on the -- but these are all expectation estimates.

So there are, I think, 2 impacts. There's a direct cost impact that's going to be, and there's a disruption impact that is going to happen. I think today, we are in the disruption impact where all -- I would imagine everybody in this industry is -- or any industry is looking at, should I increase my inventory? Should I not wait until see maybe they change their mind and maybe things will be 0, maybe things will be more. There's a lot of those questions that are in everybody's mind. And that disruption, that creates the uncertainty that creates that disruption, and that eventually becomes cost. If you don't have inventory and you have to fly your inventory instead of having to ship it by ship, you pay 10x more than the usual shipping costs. So all of that is disruption, and all of that will eventually become cost. How much of it will be passed to the consumer is still unknown. Definitely, somebody is going to have to pay for it.

Yes. So I was just wondering the alternative as to whether some of the products are just withdrawn and the patients and consumer suffer materially, particularly over the withdrawal of some generic products given that the majority of prescriptions written in the U.S. are for generics.

Yes, that will be also another possibility. As I said, some people will just say, look, I cannot afford it anymore because half of what I was going to make, I'm going to be paying my partner. And at this point, it's just not worth the effort, and they will pull out, and shortages will happen. This is a big possibility. And this is why there has been a lot of hesitation on should we be tariff -- put tariff on the finished goods or on the API, on anything. It's still not clear, I think, because they are thinking, is this going to be an impact that would eventually impact the patient? And a lot of people say it might.

One quick one. Charlie Haywood with Bank of America. A quick question on use of transfer pricing. So if you're importing your finished goods -- or make the finished goods from Portugal, what -- how much transfer prices do you use when you transfer that to the U.S.? Or I guess another way of looking at it in terms of your tax base, have you disclosed how much U.S. corporate tax you pay or sort of where you are?

I don't think we can go into that level of detail. This is very sensitive information.

The one thing that we are also confused about is some of the -- so you have agreements usually with partners where you share royalties. And right now, we think that royalties will also be taxed. So it's not only you'll be tariffed when you bring the product in, but the tariff will apply to anything later on that you have an agreement to pass some of the profits back to your partner. It's not clear, but we have been told that if there is tariff that would be also -- if there's royalties, that will also be tariffed, and that will impact a lot of manufacturers. We don't have that much luckily, but I think a lot of our partners, a lot of our competitors.

[indiscernible] prices or not?

Yes, I mean what -- it's -- we spent a lot of time talking about the uncertainty, but it's not only for Hikma. I think we all know that there are going to be a time where a lot of changes are going to happen. How much of an impact is going to be, we don't know. We think that we will be, though, in a better situation than a lot of our competitors, having the philosophy of manufacturing locally, which we are now doing it, and we have been doing it. So I think the impact will be less. I think our business is strong. We look forward for you to come and see it on your own eyes to see how our factories, our investments, our products, our R&D center in Cleveland, if you happen to also join us to Cleveland, our new factories that we are refurbishing and expanding. There's a lot that is happening in this company, and we are really looking -- very happy with how we see the future coming. There are hiccups. There are changes. There are surprises, of course, in any business, but it's how you smooth things out and how you react to it is what counts. And I think we do this very well. So thank you very much.

This concludes today's call. Thank you for joining. You may now disconnect your lines.