Welcome to the Hikma April trading update. My name is Betsy, and I am moderating your call today. If you are streaming via a web browser, kindly press the Q&A button and type in your question. If you are on the phone, please press star 1 on your telephone keypad to ask a question. I will now hand you over to your host, Riad Mishlawi, from Hikma to begin. Riad, please go ahead.
Okay, well, good morning, everyone. Thanks for coming here. Good to see you all again. As you all know, we had our press release this morning. We reiterated our guidance for this year. We had also stressed certain points. I'm just gonna go through some of the messages that we had put across. The first to start with is we're very happy that we started the year and picking up the momentum of last year, so it's been a strong approach to all three businesses. As you know, last year we talked about capacity for the Injectables for quite some time, and we did tell everyone that we had installed two new lines. So we're seeing the benefit of those two lines now. They had relieved a lot of the problems that we have with capacity.
Now we feel that the lines are giving us what we need. The Branded business is off to a good start. We were also always talking about the currency, especially the Egyptian currency in that area. And we've you know, I think Khalid will talk about it a little more, but we see it easing off and better than expected. So we feel that this division is also off to a good start. Generics is also performing well. You know all the story with the sodium oxybate and the momentum there, and we feel that this is continuing, especially on a top line. And you know we will answer some of the questions that I'm sure you have. And last week, most importantly, with this division, we had announced a change of leadership.
I think we always felt that this division in particular we needed to be, we need to improve our R&D, R&D output and new products, BD, and so forth. So we had, you know, we announced last, last week was it last week? Yeah, we announced last week that for the change of leadership and, you know, Hafrun Fridriksdottir will be joining us. She has an incredible career in R&D and in the technical aspects of this industry. And we feel that she will fill in a gap that we desperately need in that division. And overall, we're really excited. I think we are offering to a good year, and I hope this continues. We are pretty sure and confident that this will continue, and this is why we reiterated our guidance.
With that, I'll open it to all of you to ask your questions. Please go ahead.
Thank you.
Yeah.
So, thank you to Alistair Campbell from RBC. Maybe we'll just start with about that change of leadership in Generics, more specifically, increased emphasis on the pipeline R&D. Do you think you'll be able to deliver that and achieve that within the currency of broad margin construct you've set as for that business going forward?
Yeah, I think so. I think there are two different things, you know, the change of leadership will bring two different things. The first is strengthening our R&D. Our R&D output, it's been weak. We have a very soft, you know, very soft submission rate, very soft, for you know, our portfolio has been very soft for the future portfolio. So that's the first thing that we need to strengthen. I know this doesn't come overnight. That takes time to build. But the structure of this needs to be put together, and the focus on getting this started, and picking the right product for this division. I think the experience in doing this is very important and very positive.
The other thing that it brings in is, as you all know, we want to invest in this business. We want to get products. So the evaluation of which products should we go after, what companies can we co-develop products with, what companies can we acquire products with, and what should we acquire. You know, there are a lot of aspects to this that we need that deep technical knowledge to help us making that assessment. I think she will definitely bring in a lot of that value in.
Maybe just a follow-up question on the back of that, Emily Field , from Barclays. If you could just perhaps describe, you know, within Generics R&D, are there any particular therapeutic areas or, you know, looking at more complex Generics, more respiratory, if you could just maybe expound on sort of opportunities for enhanced R&D investment just within Generics?
Yeah, sure. I mean, of course, we want to go to something that we're a good technology and something that we're good at, something that we can manufacture ourselves that would be even better. So, as you know, we're good in nasals and respiratory products. We have lines for those, with a good technology. We have also a good market share with some of those products. So we just need to build on that. So this is the focus, is how to build the products that we have to develop or acquire or add to the portfolio that we currently have. I think that's the focus. Also, there's a focus on what technology should we get into. We have a huge plant in Columbus. I'm not sure if any of you have seen it, but it's an absolutely beautiful great area and has a lot of technology.
We can absorb more technologies. We can invest in those technologies. I think it's the same concept that we did with Injectables. Injectables, our success is we wanna we wanna head not only after products but also after technology. That will create differentiation. Complex products is definitely something that we wanna get into, but that takes time. We will start, you know, building that. We have some in the pipeline, but we need to build more. But also technologies is something that will create great differentiation between us and our competitors.
Great. Thanks. It's Max Herrmann from Stifel. Just one, going on to, you know, your R&D focus. A bit of an update on the Ellipta collaboration that you had and what the progress is with regards to that in the Generics division. And also, there was a big change in Advair, and it's, you know, the Generics hopes at the beginning of the year and are trying to understand what was the driver to that. Glaxo seems to have given up on defending that franchise. And then maybe with Injectables and the increasing capacity that you talked about with the two high-speed lines. I mean, obviously, the rate of growth in the division means that that capacity will be used pretty quickly. So what are the plans in terms of expanding beyond those current two high-speed lines? Thank you.
Yeah, great questions. The first one for Ellipta, I can give you more information. I can tell you that the collaboration is continuous. There's always an update and evaluation, and I'm happy that Hafrun will also help in the evaluations of where we are, what we need to do, and how can we accelerate this. This is something that would be very much, you know, our desire to add to our franchise that we already have today. So, I think, her experience and her assessment of where we are will be very valuable in this case.
As far as, you know, Advair and what's happening this year, yes, when you know, at the beginning of the year, as you know, with the Inflation Reduction Act that they had, there were a lot of, GSK seems to have decided to let go of some of the market share that they had. And, of course, as you can see, and you all probably can see that we had to increase our market share with Advair. And, you know, the two you know, we have about 45% of the market right now, and I think Mylan has the 40%. And so I think there's an opportunity for us to pick up what GSK had left off.
Of course, that needs this is a complex manufacturing, and we need to make sure that our production is up to par and we pick up the contracts that we can deliver. So we are very busy doing this, and our salespeople and commercial people are doing a great job with this thing. So it has been positive for us. As far as the capacity in Injectables, we have a good problem in Injectables. That's whenever we add that's here. Whenever we add capacity, it seems like it gets consumed very quickly. So it's good. The demand is there. The only problem with that is adding capacity in this particular technology or particular segment is not easy. You know, you need to have planning. But luckily, our engineers are always ahead of the game.
We just started building our fifth plant in Portugal. Actually, we started breaking ground around two weeks ago. Equipment has been ordered. We have huge orders that have been ordered, lines that are already on order. This will take a couple of years before it actually materializes. But we're excited about this. So as soon as we got new lines coming in as you know, as you know, the expansion of capacity in Injectables has been going on beyond Portugal. We have added a line in Cherry Hill last year. We added also a fast line in Portugal. We have completed two plants now in North Africa that will be validated this year sometime. Probably will open the doors towards the end of this year.
Italy is also, we doubled the capacity there, and they're in the last phases of, you know, validation and installation and so forth. And that should be coming in also at the beginning at the end of this year. But we also feel that, this unit can also absorb a lot more demand, especially with contract manufacturing and other with the growth of our products. As you all know, last year, we added 17 new products to our pipeline. This year, we're also adding some good number of products. So we're always growing our portfolio. Demand is growing. Contract manufacturing is growing. So capacity is definitely will always be needed. And we are planning ahead of time to continue adding capacity as we go.
Okay. So Paul Cuddon from Numis, just going back to Generics, I'm afraid, but you seem to be painting a picture of a sort of weaker pipeline to come through in the kind of years ahead. So I'm just wondering to what extent your previous $100 million-$120 million base profitability is more uncertain, or is your new plans intended to grow that baseline generic profitability? So that'd be the first question.
No, I'm very confident that the 100-120 that we had previously given the market is something that we can stick to. And that would be the minimum number if we wanna improve on that. We wanna make sure that the foundation of this division is strong, and we wanna build the future. So we don't wanna depend on what we have today but what we will have and can get in the future. I think there are two things that we wanna, you know, the changes that we're doing in this division shows. One is our commitment to this division. We believe that this division has the right foundation. We just need to make sure that we create a future for it. We have the right technology.
We are in the right location in the United States. Fantastic quality record. We have outputs, you know, one of the largest facilities in the U.S. So we have all the elements to make this more successful than the way it is. I think what stands between us and doing this is creating a future, creating a portfolio of products that, you know, it seems like we've had products coming in every other year, maybe every 2-3 years, and, you know, we shoot up, and then that product comes down, and we come down with it. We should be able to do that consistently. We should be able to have a momentum of products that when one comes and then comes down because anything that goes up is gonna come down eventually, you have one right behind it.
It seems there's a void and a gap. And this is why everybody is not trusting this division in a way, and sometimes we call, you know, the cyclicality of this division and so forth. But I think we can fix all that. And the way to fix that is with a strong portfolio and a strong pipeline. And that's what we're planning to do.
Okay. Thank you, and no de-emphasis on the specialty portfolio. That would be something that you sort of continue to kind of increase the mix of within Generics?
Yeah. The specialty is a fantastic idea, but it's a very difficult, it's something that we really need to do, but we also need to make sure that we are realistic about what we're doing. So although a specialty business is something that we wanna get into, it creates differentiation between us and other competitors. It gives us something on top of what we have today with a baseline of generic products. But we also have to know that we need to commit to it, and we need to have more than one or two products in the basket because it does require a lot of money to detail those specialty products. So, this is one of the things that we want to do.
This is one of the things that we've talked about, you know, what Hafrun can help us do and this assessing what other products can we add to that basket. Because really, it's not, no matter how big the product is, the promotion of a product, a specialty product to the market is extremely expensive. So the more you have in that basket, the better you absorb that cost. And I think, so this is where our focus is. Our focus is how can we make this specialty more successful than it is today. We're on a good start. I think we have a couple of good products. We've. They've been growing, and I think they have a good future.
But they will not have a fantastic future if we don't add to that basket most of it or be creative in getting something else to absorb the cost that we have. So we have a lot of ideas, and we're working with a lot of different ways, but this is something that we recognize that we need to fix.
Okay. Thank you. And just for me moving on to the U.S. Injectables business, obviously, Custopharm has been a fantastic acquisition. It's been a good contributor to growth. But focusing more on the organic growth drivers within Injectables, will that be lagging your 4%-6% guidance for the division, or could that be sorry, 6%-8% for the division, or could that be kind of up at that level, on an organic basis?
Yeah. We have, you know, as you have seen, the two main changes that we have made since I took over and it's only been 6-7 months is that we appointed two presidents of two of the three divisions that we have very strong in R&D, very strong technically. And this is really to make sure that because we believe that the future comes with good organic R&D, good understanding to technical good understanding to good technical knowledge that we need to get to, you know, within our company. Bill, who took over my role and president of the Injectables, is a PhD in chemistry, and he's been in the R&D for quite some time, all his career. Has great understanding.
And in the very few months he'd been in this role, he had really improved the R&D and organized the R&D. And I'm very hopeful and, obviously, if you see what we had done last year and how many products that we had introduced to the market, and this year, we have a great output coming in. But I think the output is coming from simple products. We're concentrating on the more complex ones. So that's what Bill had brought in. I think we need to do more of that. I think there are a lot of ideas of how to do it, not only organically 100%. It could be organically, but it could be with help with other people that have a specialty.
Co-development is something that we're looking at, partnership with API companies that we can make a specialty API for all of those new concepts, are things that we are very active doing in the background right now. Of course, unfortunately, this is a business that you know, I did say before, it's like a Christmas tree business. You know, you plant the tree today, so you can sell it in 6-7 years. Nothing that you do today is going to show you tomorrow. But I think you need to see the activities that happen today that you can predict what happens tomorrow. And I think this is what we're doing. We're trying to plant as many trees as possible. We're trying to make sure that we have the right processes in place and invest in the right place.
It's not the lack of investment. The most important thing about R&D starts with not investment, to be honest with you. It's about picking the right product. Picking the right product means you need to know, have a good understanding of the market, good understanding technically with the products and so forth. And I think this is where we see both the likes of Hafrun and Bill bringing in. And that's why we have made those changes, and they're actively working towards that.
Victoria Lambert from Berenberg. I just wanted to get a better sense of your biosimilar strategy. So, I know you do partnerships. It looks like you are well covered for some oncology products. But just wanted to get a sense of your exposure to immunology and ophthalmology biosimilars. Would you guys look to launching these products in MENA with a partner? And do you manufacture most of these products on behalf of your partner? And then just have a question on sterile drug compounding, how that's going, if you have all your licenses, and then you expect to be break-even.
Okay. So for the first question, biosimilars, it's, it's a very tough, tough industry as, as, you can hear about it from, from, you know, from what everybody's doing. Some people are doubling, doubling up on it. Some people are just exiting, by the way. It is not as, it's, it's a crowded market. And I think it becomes extremely lucrative when you are the first, first, second, third, maybe, you know, in the market. That's when you really make a lot of your money. We, we came in we are not, we came in with partners because we can't make this ourselves. So we had to partner with people. And I think we partnered with the right partners because we do have the right, transfer costs with them.
I don't think we are going to be number one, two, or three of those three products or two products that we have. So I think we have to wait and see. They might come to surprise us. But in either way, we feel that we can compete. If not because we are one of the first in the market, it's because we have a good cost base. I think we can compete based on that. This is in the US. In MENA, it's a different story. In MENA, we're leaders. We are partnering with Celltrion, and we have about seven products now. Is it seven? Six, seven, seven, right? We have seven products, and it's growing. We have a commitment and a great partnership with Celltrion to take their entire portfolio to MENA. We've been growing the market even more than the brands themselves.
We have captured, not only market share from the brand, but we're growing that ourselves too. We have plans to sell the product ourselves in MENA. It's something that we know we're in discussion with our partner with. So I think in MENA, we are on a good footing where we where our future is very bright. And I think we will be growing this business significantly in the next few years and adding more to the portfolio. US and Europe, we're—it's a different strategy. Again, we are not, you know, the pioneers and the leaders, but we think we will benefit from this as we get those two products approved. As far as the compounding, we are happy with where we are with the compounding.
As I always said that, you know, compounding is a great business. You know about you—you seem to know a lot about compounding, so you really know that it is a good business. You know that there's a lot of potential of that business because a lot of the hospitals that can be that business in, until they trust the partner, they really don't wanna, you know, give up what they have. But they would like to give up what they have because they're not in manufacturing. They are a hospital. But since they need they have that need, and they need to satisfy it, and they don't have many options, so many of them are choosing to keep it inside. This is where we're coming in, and we think we have the potential to grab this business.
But we need to be careful also. We need to make sure that we start very slowly. We keep growing. We create foundation and trust. And little by little, we add partners in. This is exactly what we're doing. We have all the states right now, all the significant states, not all 50. I think there are a couple that we chose not to go after. But the last one was California, and we got approval for that. It is growing month-on-month. We had the change of leadership just. We announced it internally just a couple of weeks ago. We've recruited people from good, reputable compounders, companies that do exactly that. We had built a good structure. We changed the structure to be a little bit more now that we have the infrastructure in place and the manufacturing in place.
We concentrated on what to do with the commercial. So a lot of things going on, but we are very careful. The last thing that you want to do is disappoint somebody, make a mistake, not be able to deliver a product. So we really need to build that because we feel that this is a great potential. And if we do it right from the ground up, we'll end up with a very good business in a few years.
Hi. I'm Peter from Citi. Hope you both are well. Sorry for being late. Three topics: Branded, business development, and compounding. I'll try and be quick on each. But on Branded, despite what we're seeing across the region, despite FX, geopolitics, you know, this thing this business is performing extremely well. So can is this just broad-based strength and execution and strategy, or is there anything you'd call out country-wise or product area-wise that's driving a better performance from Branded? That's question number one. On BD, Riad Mishlawi, I know you're not gonna say what you're doing, but could you at least just characterize the environment for doing BD this year? I mean, should we expect that, you know, something can get done? I know what you're, you know, you have to repeat what you are where your focus is. I know that.
But I just wanted to get a sense, you know, get a sense check [on] the environment for BD, good, bad, or ugly. And then last, just coming back to the compounding business, this partnership you have with Civica all those years ago, once you get critical mass for service levels, does that turbocharge this compounding business, or is that step too far? Because I know they're a very large hospital network. I'm just wondering whether your existing Civica collaboration would turbocharge your compounding business over time. Thank you.
I'll speak a little bit about the Branded. I'm gonna give it to Khalid to talk about the currencies and what happened there. But as you know, in the last few years, we have been really investing in the Branded business. We've been adding many facilities, especially in oncology. Our chemical facility, our API facility, has been working very hard trying to get the unique molecule for oncology to service all these new plants that we have. So we have a new plant in Algeria. We have a new plant in Morocco. We have one in Egypt. We are really covering the whole area, especially in oncology. And this has been growing very impressively. We are backward integrated, and we've been really spending a lot of money expanding our API facility.
As you know, our API facility was extremely small in the past. So we never really give it a lot of attention. But in the last, I would say, 5-7 years, we have been looking, we have changed the strategy, and we started focusing on it. And we've put some money into it. And right now, we're seeing, you know, the fruits of all that. So this is one big element of why the Branded is doing well. Also, in the last few years, we've been investing a lot in BD partnerships.
We did very well in also going from, you know, providing medicine more into the diagnostics now, more into a lot more, transferring maybe transforming the company. I wouldn't say transforming, but adding to what we have, from provider of medicines to also providing solutions to medical to more of a health company rather than just a pharmaceutical company. That has been entirely throughout all of the region. Locally, we've been expanding our facilities. As you all know, there are a lot of facilities being built in that region. The last one that we're planning to break ground very soon on is in Saudi Arabia. This is going to be happening very, very soon. So a lot of activities have been going on the Branded. Maybe we never really talked about it to everybody.
This is why, but if you look at the last two years, the Branded little by little was doing has been doing well. And this year is not an exception. So that was one element. And there's an element also of, you know, the currencies and all this. And do you want to, Khalid?
Yeah. Just maybe, before heading into currency, it's the performance has been driven across all markets. So all markets have been doing very well, even in Egypt, although we have seen the currency and one of the reasons why we've upgraded or slightly upgraded our operating profit guidance is the reason currency has been better than what was expected. When it's gonna stabilize, maybe there could be a further upside. But so far, what we are seeing, we're seeing very good momentum. And this momentum has been driven across all markets.
few questions about BD and M&A. We have talked about the strategy that we have. One of the strategies is looking for the future. I think this is one of the things that we have to strengthen because when we come to you and give you our results, you have already, you know, you want to go and say, "Okay. What's next? Where's it going in the future?" And I think this is where we have to concentrate on. I think we're confident in what we do today. We're confident in what we can deliver at the year that we're talking about. But you all want to know, and we want to assure you of what happens in the future, what will give us more in the future. This is why you're always asking about compounding. You're asking about all those, you know, potential, you know, breakthroughs.
I think this all happens with BD and M&A, and, of course, with the portfolio R&D, building an R&D. This is where our focus is. This is why Hafrun, this is why Bill, is here. That's why Hafrun is here because we feel that that is where we need technical people to evaluate. We need technical people to be able to build our R&D. And with those people added to our network, to our company, we really can do better in R&D and BD. We can evaluate better. We can be assured, you know, that this is the way to go. And I think this is exactly what we're doing. So we did that in the R&D, in the presidents, in the management.
But we also did the same thing in the structure that we have. So in our BD and M&A's department, as you know, in M&A and BD, we have restructured this department, added a lot of competent people to it. And we are focusing on this because we feel that this is an opportunity today. As you know, we have a good balance sheet. A lot of companies don't. They're highly leveraged. And we're seeing a lot of opportunities. So this is the time now that we have to evaluate to see what we can grab, what would be synergetic with what we have today. And there are targets. And currently, we're evaluating many. And I hope by, you know, end of this year, we should have some, hopefully.
Compounding? Okay.
Well, compounding, I keep saying the same thing. It's a business that you know, we all know. You know, we started out thinking that this business is very much similar to the core business that we have. And it is as far as the product, as far as the GMPs, as far as the controls that you have in manufacturing plant. Where it differs a lot is in commercial. In our core business, we have, what, 4, 5, 6 customers or wholesalers, basically, that they sell the product. In this business, you have, you know, 5,000 hospitals that you have to, you know, to individual customers that you have to vet. You have to, you know, bring them in.
And you have to go through all the credit, through all the DEA licenses and all this. It takes time. It takes time. Not from us, we're happy to do it. But it's hard to get the attention of a pharmacist to say, "Hey, Bill, you have to fill those 4 pages, and we have to go through the process to get you in." And so that is going. We're putting more and more people into it to get more customers in. We feel that we can get a few IDNs with a representation of 100+ hospitals. Maybe that would do the. So we have put a strategy together of how can we expedite this process? How can we get more and more customers in? But before we do that, we want to make sure that we have the infrastructure.
The worst thing you would do is you would get orders that you cannot satisfy. So, you know, you have to make sure that both things are balanced. You want to, you know, encourage our commercial, "Go and get orders." But you want to make sure that the back, you know, your infrastructure, your manufacturing is healthy enough that you can satisfy all these orders. And we have been working on both. We have put all our systems right now. Our latest water system has been validated. We put all the equipment in. A lot of activities are happening on the ground, on the manufacturing floor. At the same time, we're doing a lot in the commercial. So they're going hand in hand together. Progress is definitely very evident. We're very hopeful. And, you know, hopefully, we'll see a pickup pretty soon.
Do you call it it's beneficial to think you leverage the Civica strategy?
Yeah. Well, we can. I think the first thing that we wanted to do is make sure that we have all the hospitals, you know. We cannot go to Civica and say, "Okay. We'll give you, but you cannot sell in this state and that state and this state." So that was one of the obstacles that we have. Now, I think with California being online, we should be able to say that. The second thing that we should be able to say that whatever order you give us, we will guarantee we give you. The whole model of Civica is that guarantee. I think the team is working with Civica and multiple other wholesalers and GPOs. And yeah. We want to make sure that whatever we promise, we deliver.
Hi. It's Christian Sheridan with Stifel. Couple of things. The usual one on generics and pricing in the U.S. What was it like in the Q1 ? And what's your outlook for the year on pricing? And then just coming back to the BD licensing partnership, you know, talking a lot more about partnerships, you know, across your division, particularly generics and specialties and others. Is that shift a response to something that you're seeing in terms of the strategic direction, or is it more a reflection of kind of your leadership, your philosophy, and how you think, you know, you should be looking outside a bit more maybe than historically Hafrun has?
I'll do the second one. I'll give Khalid to talk about the pricing and get good at numbers. For the second one, I would say it's not a shift. It's execution. We always knew that we really need to build our pipeline. And we know that we can't make everything ourselves. We know we have to go out. And if you look at some of the specialties that we have and some of the partnerships that we have, we've done well. We've done well in partnership. But I think we could have done better in execution. Some of those contracts that we have, we really did not go the whole entire way as we expected them to do. So I think it is really not a change.
We know that the future is going to depend on what products you have, on differentiation, on efficiency, on the size of your portfolio, all of that. It's just how you execute towards that. I think it's just a matter of execution. Let's take the pricing.
Yeah. The pricing, we said at the end of last year that it's always been in the pricing erosion in the generics. It's in the mid to high. So a single digit. So it's no changes to this. We're performing very well so far. And this has been assumed in our guidance as well.
Just gonna pull some questions from the line that the operator can ask.
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Maybe, just, it's almost like summarizing what you're really saying, which is that you wanna BD is really focused on building product pipeline and helping to strengthen that. Your R&D emphasis is again pipeline. So it's kind of all really focused on building for future growth. I mean, that's pretty standard for any pharmaceutical company. But so why the change in emphasis, I guess, is that not a change in the strategy there in terms of being much more focused on it?
I don't feel it's a change of emphasis. I feel that it's something that we had always talked about. I think we just need to execute. But to understand the question, I think when you have a business that have a cyclicality like what we have in the generics today, you know, you introduce the product, and you go up. And then the product starts dying off. And then you go down. And then you create this trust with your investors, with your confidence in this business. And we've seen it. You know, we've seen a lot of people question, you know, "Why are you committing to a business that, you know, you don't have assurance in continuing to deliver every year the same way?" I think we wanna change that.
I think we did say, "Look, we think this business has the right elements. I think it's missing few. And we have to go after filling those, you know, missing elements that it needs, the weaknesses." The weakness is in that portfolio. I think we have the right everything else is not only good, but it's fantastic. The site is pretty incredible in terms of capacity, in terms of size, in terms of cost, capabilities, technology. It's got everything. We have a, you know, great automation. I went for a tour with Hafrun, the new addition to the team, the new president of this. And she's been there, done that. She's been in many companies and big companies, much bigger than ours. She said this is the nicest site I've seen.
She said the automation is incredible that we have there. She said that, you know, some of the capabilities that we have is very impressive. So why are we having difficulty in making this business bigger than it is today? And I feel it is really related to, you know, keep introducing new products, keep being very active in development. I think we kinda relaxed. And the reason why is because the reason why I think mainly, we had a lot of changes in how we set up R&D and who led the R&D. You know, we've took R&D from BI when we acquired this facility. Then that had changed. Then somebody else had come in and stayed 2, 3 years. And that had gone. And then somebody else came in.
Then we changed the structure into global R&D. So we would never really have been a very structured, focused. We know where we're going. We know what we're gonna spend. We know what we're going after. I think that's what we need to build. So it's not a shift. It's more about, you know, we knew where we need to go. We just need to execute.
Execution and efficiency as well. It's the output of the R&D rather than the spend. So it's more focus on bringing more efficiency, more output of the R&D and the investments that we are making.
We're willing to spend more. I mean, we're not spending. We always said that we would do 6%-7% of our revenue. And we're spending a little bit less, especially in that division right now. So we have capacity to spend more. And if it is justified, we'll even spend more than that. We just need to make sure that justified, we need to make sure that it makes sense and make sure that would be worthwhile.
Hi. Seb Jantet here with Liberum . Two questions, if I may. First of all, just, to hear what you're saying about the kind of pipeline in the generics business. And I'm wondering, obviously, you know, Xellia acquisition is gonna take a while to kinda build that pipeline. So how should we be thinking about the CMO business during that phase? We've seen growth in that part of the business to plug capacity, to utilize capacity in the short term. And then the second question is just on sodium oxybate. I just wanna pick up on something you said in terms of seeing volume growth there. I think the other main AG company is Volume Limited. I just wanna check whether you've got any volume limitations on your kind of AG agreement.
I'll take the first one. And the second one, do you guys want to take that one, the sodium oxybate or, as this is a very sensitive issue, so I'll just take the last part. It's you just have to be careful what to say there. But, you know, your first one is in relation to. I'm sorry. The first question was the CMO. We did, as you all know, we are in Injectables, we had built a good CMO business. The philosophy of that CMO business was, "When we build facilities, it takes a while before we fill that facilities. So it's an opportunistic type of business where we can come and sell that capacity to somebody else who's ready to take it rather than having to sit and absorb the cost." It's been a successful model.
We've done very well to a point where now we're saying, "Well, you know, maybe it should be a separate business." We're still looking at that. I think we can do it. And we're committed to do it. But we need to have the capacity before we commit to having an independent contract manufacturing unit in the Injectables. In the generics, we have the capacity. We have a very good plant, as I mentioned before, quality record, pristine quality record, in the United States. So I think it's got all the right elements to attract contract manufacturing. But contract manufacturing requires also contacts, requires, you know, who needs it, how you talk to them, how you bring it in. You transfer it. You need to transfer methods.
It goes through six, seven audits before they, it costs a lot of money to transfer products. And you don't wanna give your products to contract manufacturer, to somebody that can get you in trouble. So it does take time for you to get that trust going. It does take time for the auditing to take place. And it does take time for transferring all the methods, transferring all this. We are in this process with a few clients. But also, we feel that with the technical people that we had added with the two new presidents that we had added, both Bill and Hafrun have done this. As you all know, Hafrun's experience is in companies that done a lot of that, and also Bill. Bill was, as you know, CEO of a company that did only virtual.
So they know particularly well how this thing goes. So we're hopeful that we can with those leaders, we can grow this business well. We're committed to this business. We know that we can do good at it. But we also know that we really need to reach the right person, the right company, and offer them the right, the right, attractive, contract for them to, to be motivated to move their products to us. But definitely, it's something that we're looking very closely at. And we are optimistic that we can grow this.
So we have the good manufacturing base. We have a strong quality track record. So we want to build on that, whether on CMO. At the same time, as Riad mentioned, bringing more into the specialty. We have Advair as well as growing very well. So this business is delivering good growth. But we want, based on the output that we have, to have it much stronger. And hope with Hafrun, we are sure that we can grow this business further.
Thank you. Paul Cuddon from Numis again. Just a few GLP-1 related questions. I mean, are you distributing those for obesity applications in the MENA region? I mean, could that be an opportunity? Could you actually manufacture them yourselves with any of your kind of facilities? I know it's peptides versus sterile Injectables. But could you kind of rearrange the manufacturing? And if you're not, are you seeing any dynamic where sterile injectable manufacturers are switching capacity to GLP-1s to solve the shortages? And is that creating opportunities for you?
Yeah. Excellent question. It seems like this GLP is like the new penicillins in the world, you know? It's a new breakthrough. And we saw the acquisition of Eli Lilly just a couple days ago also for this. So definitely, it's something that we are looking at. We have partners for that, and both in MENA and in the US. Did we say anything publicly about this? Okay. So we have partners. We're looking at the different things and different options. We definitely are not ignoring this. But we know that we don't have it, you know, developed ourselves. So we have to go through partners. As far as manufacturing, yes, we can manufacture it. It's not a problem with manufacturing peptides in our facilities.
Most of those products are placed in a special delivery system like auto injectors or pre-filled syringes , both of which we can make. So I don't think it would be a problem. I think the first thing is get it out in the market. When we do talk to partners, we always have that option, especially in MENA, because you do have the preference for localization in MENA. So we can, you know, take, you know, we can, you know, consider that when we talk to people. So and for US, we are talking to partners that are able to give us the volume that we need. So it's something that we're watching very closely. We're talking to a lot of partners. Hopefully, soon, we could see something there. Let's see.
Maybe just, I know you mentioned track record in generics from a regulatory perspective. I think in some of these recent meetings you talked about the potential for greater FDA inspections or industry-wide in Injectables. I was just wondering sort of how is that materialized, and then maybe dovetailing into that, and then the question in terms of how the shortage situation looks in the U.S. for Injectables.
Yeah. The regulatory inspections, as you all know, has picked up a lot since after COVID. During the two and a half years of COVID time, there weren't much inspections, especially international inspections. Domestic and international kind of FDA had frozen. They've done a lot of virtual inspections where they ask you for the paperwork. They go through all the paperwork without having to visit the site. It has changed now. They've been very active. They've been visiting all the sites. And, you know, we've seen people that had done well and people that had done terrible. We've seen a lot of warning letters. A lot of people had stopped manufacturing. And, yeah. And the shortages continue. It's between 140-160 products now on the list. And, you know, we do have a lot of big portfolios every now and then.
We do have opportunities that come across those shortages. Our manufacturing plants are very good in turning on a dime and, you know, making sure that those opportunities are fulfilled and captured. We haven't never seen orals in shortages. But now we're seeing them. So it's not only limited to Injectables anymore. We're seeing some of the orals coming up. So this is going to continue. I think this is part of the system. It's inherent in how the system is built in the U.S. As long as there is a lot of pressure on pricing and a lot of pressure on the manufacturers to reduce their cost, there would be options where you decide to pull out from manufacturing some molecules because it gets to a point where it's not profitable anymore. And you go choose something else. So that continues.
Orals, were you referencing the ADHD meds? 'Cause it's, I've read a lot about that.
That's one of them. That's one of them. Yeah.
Okay. And antibiotics, I think.
Yeah. Antibiotics, penicillins is one. But that's different. That's more related to API. But yeah. There are a lot of different reasons why. Some have to related to quota from DEA and how they distributed some related to API. But it's new to see in orals, and shortages.
Okay. One more question, sir.
Okay. I think we'll wrap up. Riad, if you have any final words. Otherwise, we can.
Well, the final words is, look, I've been a CEO for a few months now. It's been exciting. It's been traveling a lot, trying to understand what we have, what we need, how can we satisfy the needs, how can we fix some of the problems that we have, how can we accelerate the growth. It's been very exciting. It will be more exciting when we actually show something that is substantial. And we're close. We feel that we are doing a lot now. And I think if you do a lot, then the results will show. Hopefully, you'll all see it soon. But, yeah. We have a great company, a good foundation, great people. We are a public company. We work like a small group, although we're about 10,000 people. But we work like a small company. We're a public company.
We work like a private company. So we have a lot of advantages there in, you know, capturing everybody's attention and motivation and giving the right tools to grow. I'm excited. I'm happy to where I am. I look forward to the future. Thank you very much.
Ladies and gentlemen, this concludes today's call. Thank you for joining. You may now disconnect your line.