Welcome to Day 3 at the JP Morgan Healthcare Conference. I'm Richard Vosser, European Pharma Analyst at JP Morgan, and it's my great pleasure to introduce the UCB CEO, Jean-Christophe Tellier, to you. Just before I hand over to Jean-Christophe for his presentation, I just remind you that if you have a question, please stick up your hand and wait for a microphone, or you can put your questions on the portal, and I'll ask them for you. With that, Jean-Christophe, welcome to the conference.
Thank you, Richard. Good morning, everyone, and thank you for joining me this morning for the UCB presentation. It's always a pleasure to be in front of you and share with you some updates about the company and give you the confidence that you need to get with the progress that we are making and the future and the perspective of the company, so thank you for being here. If there is only one message that I would like you (it's not a disclaimer, by the way) if I have only one message that I would like to leave you with today, it's the fact that we are in a position of strength, and the level of performance that we have been able to deliver for the last couple of years is the best possible introduction to the decade of growth that we have ahead of us.
The strength that we have today is built on a lot of different pillars that I would like to highlight with you in the next few slides. So, of course, the first element that you should be confident with is the fact that this decade of growth has been built on a very solid and strong foundation. We have a company of almost one century of history. We will celebrate our century in 2028, so it's getting closer. The foundation of the company has been a family which has always believed in the future and in innovation. These strong foundations on innovations and sustainability and success have been executed towards today two pillars. One is immunology, and the second is neurology, and is today translating in these five growth drivers that you have on the right-hand side of the slide.
Of course, the first one that you think of when you think about UCB today, it's BIMZELX, with the five indications of the product that we have been able to launch a few years ago. But it's not just BIMZELX. You see here the other products, generalized myasthenia gravis in Dravet, Lennox-Gastaut, fragility fracture that you have here. Five growth drivers is the first pillar of the growth and the first reason of this decade of growth ahead of us. The second element, sorry, I should mention another thing on this slide. The second pillar of growth that you have to think of when you think about UCB is the fact that we have a huge visibility ahead of us. The green dot that you see on the right part of the slide, almost outside of the slide, actually, it's the delay between now and the loss of exclusivity.
BIMZELX, for example, the loss of exclusivity will be in 2037. So with these five growth drivers, we have ahead of us a huge period between 2033 and 2037 before we will have to face the next round of loss of exclusivity. So strength with the growth driver, strength with the visibility that we have ahead of us. The strength that we have today is also the result of a strategy that has been executed with agility and resilience. And it's also something that illustrates UCB and has been illustrating UCB for a while. So if you think about the first element, which is the innovation piece, we always have invested more than our peer in R&D. And this level of investment for the last years, at least the last decades, has created the strength that we have today.
The second element is we are continuously investing in areas and in geographies that support innovation, and in the current environment, and particularly here in the U.S., we have decided last June to expand our manufacturing capacity and build a state-of-the-art mammalian factory in the U.S., which will be an investment of $5 billion for a company our size. It's quite a significant investment, but it's also an illustration of the growth that we have ahead of us and the ability that we will have to produce more regionally and to be closer to where the innovation is, and at last but not least, investing in our own research is, of course, very important, but it's not everything. I don't think there is any company today which is able to grow long-term without a combination of organic and inorganic growth.
And the other pillar of strength that we have today, it's our strong balance sheet and the strategic flexibility that we have already today to invest in potential inorganic growth in order to strengthen, accelerate, and give us even more solidity in the future. So if you think about that, for us, we will, of course, start with early stage with research, strengthening our discovery engine, because with five growth engines right now, we have enough on our plate, and we don't want to add additional elements now. I cannot resist the pleasure of spending a little bit of time on this slide, right? Because when you look at the strength of UCB, it's the ability to deliver results, which, of course, is the most important one to give confidence in the future. And this is not the result of the growth of the last 10 years, actually.
It's just 2025 versus 2024. So you can see 24% of growth, and you can see 700 basis points of improvement of EBITDA. Being here for the last 12 years, I have heard a lot of the time skepticism. When we put the guidance to say we will reach more than 30% by 2025 of EBITDA, there have been some questions about how you will get there. Now it looks like 31% is quite conservative. Frankly, I like to be in this position on making sure that we can deliver what we have promised and show confidence in the future. When we look at the strategy in action, I would like now to zoom a bit on a few elements. The first one, it looks maybe general, but it's the reality of the company, and it's the reality of where we are today.
The focus on innovations, the ability to invest in research and science, is the heart of the company because we always believed that if we are able, and as long we are able, to translate science into differentiated candidates, we can deliver additional value for people suffering from chronic disease. And the way to do that is, on paper, quite simple, not that easy to execute. But the first thing is, first, better understanding of biology. If you understand better the human biology, if you really put connections between the patient and the science, then you can extract from this knowledge an ability to formulate differentiated hypotheses, scientific hypotheses, that then you can translate into different candidates.
If you are able to execute on these sciences, develop faster with a higher probability of success, which we have been able to demonstrate with BIMZELX, for example, and execute commercially, which we are demonstrating today, then you completed the circle from innovations to results that should give you confidence in our future. The last product of the portfolio is KYGEVVI. KYGEVVI is a product which is the first and only treatment today. Just got approved in the U.S. It's a rare disease. It's even an ultra-rare disease for kids suffering from TK2d deficiency. And this is really a very severe disease for the kids. The only treatment available. So it's not a big patient population, but it's here also a good illustration of what one patient's value means and what unique differentiations can create. The second element of the pipeline that I would like to illustrate is galvokimig.
Galvokimig is an illustration of a multispecific antibody targeting different pathways. It's a natural evolution. If you think about science, it's a natural evolution of how we can evolve and how we can progress in the treatment of autoimmune disease. By nature, autoimmune disease is not just the result of a dysfunctioning of one pathway. It's multiple complex consequences of malfunctioning of the immune system. And so after targeting one interleukin in certain disease, it looks natural to try to combine different targets together and have in one monoclonal antibody an ability to target different interleukin. With galvokimig , we have the combination of an IL-13 and an IL-17A and F. And by doing so, we hope that we will be able to provide additional clinical value for patients suffering from atopic dermatitis in the first disease that we have evaluated the drug here.
If I move now just to get one example in neurology after having covered immunology. Alzheimer's disease is a very complex disease, of course, and it's not an easy one. We think that with bepranemab, we have something quite unique there, the first time that we have been able to demonstrate clinically some improvements in patients suffering from Alzheimer's disease with an anti-tau treatment, and we think we have a good option there because we have been able to demonstrate with human cells that we were targeting the right epitope that can translate an anti-tau into a clinical positive outcome, so as you can see from a pipeline standpoint, I just highlighted three components. I could have added dapirolizumab for lupus that we have with our partner, Biogen, which is in the second Phase III now, and it's also a huge unmet patient's need, right?
You can see multispecific, dapirolizumab pegol in lupus, bepranemab in Alzheimer, KYGEVVI in rare disease. You can see that we have already in the phase of preparations of the future of the company. Pipeline is one. Execution is also another one, right? And you can see here what has been very specific for us, and we have not been used to that before, on the launch of BIMZELX, is the speed by which we have been able to complement the first launch of one indication in one country by a launch globally in multiple indications. In less than two years, we have been able to reach 50 countries, five indications. And we have still some to come with pediatric studies and with PPP that we have started to develop. And that's how it translates into results, right?
More than 100,000 patients have been treated already today with BIMZELX in just two years of treatment in most of the countries where we have been able to launch. We have no additional elements there, no signal. Things are going very well. The feedback of the patients and the physicians on the product has been amazing, which is translated in the graph below where you see the dark green in terms of patient acquisition, which is above competition. Once again, I think with the level of competition that we are facing, I think it's pretty remarkable there. For 2026, we are happy, and we have published that yesterday in the press release. We are happy to add 36 million lives covered.
And so we will be able, which is an increase of 25% versus 25, which means that now we are able to cover already 80%, less than three years after the launch of a product in such a competitive market. We are already covered 80% of the commercial lives. But as I said, the growth drivers are not just about BIMZELX. We have also other products that drive the growth of the company for the next 10 years. And all of them illustrate very unique specificity and outcome for patients. EVENITY is still today the only anti-sclerostin which is able to build back bone at a moment where you need it, which is able to translate into 50% reduction of fragility fracture. And what means life expectancy going up if you are not able to get the bone and the quality of the bone that goes with it.
RYSTIGGO and ZILBRYSQ are two portfolio brands that we have in generalized myasthenia gravis. RYSTIGGO is the only one that has the indications broader between MuSK and anti-AChR, and ZILBRYSQ is an anti-C5 on a daily indication, daily prescriptions and dosing, which is a very important one for younger patients who want to stay active and to control the disease all over the year. And last but not least, FINTEPLA and BRIVIACT and EVENITY. So you see a full portfolio who will drive the growth and behind the pipeline. So the last thing that I wanted to share with you is really to leave you with this message.
UCB is a company today which is very uniquely positioned in the industry today in terms of ability to enter into a decade of growth, visibility with very limited numbers of products with a lot of exclusivity in the next 10 years, plus the evolutions and the investments in innovation that translate into a solid pipeline, and an ability to execute both from research to development and to commercial executions that fully provide the results that we want to see from research to the patients. Thank you very much for your attention. Thank you for your confidence. And with that, Richard, I hand over for the question. Thank you.
If there are any questions in the room, please put your hand up. Maybe I'll kick off. Jean-Christophe, you highlighted the incremental patients and lives covered on BIMZELX that you've been able to achieve. That presumably comes with elements of increased rebates to the payers. How should we think about that, the balance of that as we go forward for the growth of the brand in the U.S.?
Yes. No, Richard, it's a great question, of course. And it's a fine line, finding the right balance of how much you want to cover patients and get access to the patients versus the gross to net that you leave on the table. So two elements that I would like to illustrate on that. The first one is we have never considered price as a way to capture new patients. We wanted to be at the level of the market. We wanted to make sure that we follow the rules of the market, and we provide the best access that we can. But we didn't want to push the rebates to a level that can stimulate even further competitions on price. Why? Because we have the differentiations, and we have the outcome. Don't forget we have already published three cooperative studies versus standard of care where we have demonstrated superiority.
These have been really instrumental to make sure that all of the three major PBMs include us since the beginning in their formulary. And so we are very happy that just at the first year already, we had already a very solid coverage. And these positive coverages give us an additional opportunity to switch patients from our bridge program, which was ability for the patients to get access to the drug but didn't create any revenue for us, and shift the patients faster to commercial coverage, which have helped us in 2025 to increase and to get a good level of revenue. So yes, 36 million additional lives covered in 2026 translate, of course, into fewer medical exceptions and fewer patients who pay full price and additional pressure on the net price. But once again, we had already the contract. We had already the coverage.
We have no exception in the PBMs and for the major indication, and then we are able to expand that now, which means that after three years, we can be very confident that if a patient needs our drugs and if the physicians want to prescribe the drug, it will be able for the patients to get the drug, and you know how important it is, particularly in this market, where sometimes the time between getting the prescriptions to being able to actually benefit for the treatment is sometimes weeks and even months, so it was important to get this volume in order to make sure that the environment was not creating additional hurdle if the willingness to prescribe is here, but doing that with a minimum impact on the net price is something that we wanted to achieve, and I think we have a very good balance now.
One of the indications that boosted the growth in 2025 was HS. And that was a relatively new market. So how's been the ability and what's the ability going forward for you to sort of expand that market with there is another IL-17 as well?
Yes. Yes. Yes. No, absolutely. I mean, HS is a new market. It's a new indication. And it's a market where it's not so easy to treat patients. And you just need to keep in mind two things on HS. First is patients suffering from HS very often, we are very disappointed by the treatments they have been able to get so far. And because of the disappointments, patients have left the classical circuit of treatment or connection with the healthcare system. And many of them actually are out of the system, treated from time to time with antibiotic or with a surgery, but are not connected completely with the dermatologic environment. So we have to bring them back, and we have to educate them also and to let them know that there are new solutions available for them that will help them to treat their patients.
HS growth is there. It will be there for the long term. Epidemiology said that basically 1% of the populations may suffer from HS. We are far from having these patients connected to the system, being diagnosed. Average time between early symptoms and diagnosis is more than seven years. We need to reduce that, and we need to treat patients earlier and earlier in order for them to benefit, but the benefit of the treatment, and particularly BIMZELX, is real. I just want to give you one illustration of that. In our Phase III clinical trial in HS, the patients were all severe at the beginning of the study. None of them described their state as mild or moderate. At the end of the study, more than 50% of the patients considered that they had a mild disease expression.
You can see the impact of the drug on the disease. I'm very confident that we can leverage the differentiations and the power of dual inhibition of the IL-17A and IL-17F for these patient populations. The growth in this indication is just at the starting point because we will bring more patients to consultation. We will shorten the time of the diagnostic. Because of that, patients will be better treated. There will be much more motivation to follow the treatments and to continue to be adherent to the treatment. Today, we have already three years of exposure to the product in our open label extension. More than 80%, 86% of the patients who have been controlled at the beginning continue to be controlled after three years.
We are very confident that despite the severity of the disease, despite the complexity of the treatment, BIMZELX is a huge potential tool in the toolbox of the physicians to provide to the patients the relief that they need.
I think in the excitement on HS last year, we sometimes forget that psoriasis is a very, very large market and still growing today with biologic penetration and PsA too. So maybe you could give us some color on how BIMZELX is performing there and what the opportunity set you see?
Yes. I mentioned in the slide that you have noticed that what was very different from UCB before UCB with BIMZELX was the ability to launch in many markets at the same times almost and in many indications, so we have five indications now, and as you mentioned, HS is just one of them, which creates a lot of excitement because there is not a lot of solution, and so you can feel and see the growth for the future, but the other indications are also very much present: psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axSpA. We are present in all of these indications, and we are doing well, and we are growing in all of these indications. There is one element that I would like to highlight here maybe. It's the psoriatic arthritis.
I mentioned already the growth opportunity with the additional coverage and access in the U.S. I have not mentioned the other elements in 2026, which is our head-to-head study versus IL-23 in psoriatic arthritis. We will expect results in this study in the second half of this year, and our expectation is that we will be able to demonstrate superiority versus IL-23 in psoriatic arthritis. It will be the first time that we can demonstrate superiority versus this product in this class. The reason why we have chosen psoriatic arthritis is because we feel that the pathways of IL-17A and IL-17F is very important in psoriatic arthritis. Actually, it was the reason why initially we had this hypothesis that targeting both interleukin will create more patient value because of the high level of IL-17F in the joint of patients suffering from psoriatic arthritis.
So of course, if we are able to demonstrate that we are superior to IL-23, you can imagine that we can have an additional growth there. But we feel also that the growth will not be just for psoriatic arthritis, but also for psoriasis. Because one patient out of three today suffering from psoriasis will have psoriatic arthritis one day. The problem is you don't know which patients will have and which will not have. And so if it was you and if you suffer from psoriasis and you don't know if you may be subject to have psoriatic arthritis in the near future, it's probably better to choose immediately in psoriasis to be treated with the product which offers the best coverage for your skin and your joint at the same time. So as you said, Richard, HS is the most recent indication, but we have others.
In particular, the ability to provide other and further elements of differentiation, in this case, psoriatic arthritis versus IL-23, will help us also to grow in other indications such as psoriasis.
I think you snuck on the slide PPP as well. What's the opportunity there and what could we see?
From a clinical standpoint, the PPP opportunity is a very important one. If you think of a disease where basically you cannot walk and you cannot hold anything in your hands because you have trouble on both palmar and plantar. It's another illustration that sometimes quantitative percentage of skin touched with the disease doesn't mean a lot. Because if you look at palmoplantar pustulosis, it's basically probably 5% of your skin. But these 5% are so critical that you cannot live a normal life. So it's a rare disease. It's not a big patient population. But it's a very damaging disease.
It's a disease that creates when you suffer from it, which creates a huge impact on your quality of life, on your inability to have a normal life, to go to work, and just to walk and just hold and do the normal things of the daily life. It's a quite damaging disease. We've started the study right now. So far, there is no treatment available. Even if it's a small patient population, it's a nice and it's a very important addition to what we currently have.
Maybe we could pivot to the pipeline. You highlighted on the slides galvokimig, which we've seen strong data in AD. You also have donzakimig as well, potentially, with data coming up at your results. How should we think about the early positioning of those two products in AD? And you have a large R&D budget, but how do you think about progressing both those agents?
I think it's a very fair question. As I said in the presentation, I do feel that multispecific antibodies in autoimmune disease in particular, it's a big part of future treatment for these patients. And the reason is the diversity and the complexity of autoimmune disease and immunology in particular. If you think about all of these diseases, you don't just allocate or dedicate one disease to one pathway. It's much more complex than that. It's not an anomaly of one pathway that creates the disease. It's much more complex than that. So it seems natural if you feel and if you understand better the biology of autoimmunity and the fact that the system does not recognize itself and stimulates antibody towards targets, which are normally your own targets.
You can think that multispecificity and addressing different targets at the same time is the way to go moving forward for autoimmune disease. So that's the point number one. The point number two is it's, of course, very natural for UCB to dedicate time and resource for this potential evolution. Because with our centers in Slough in particular, we are very strong in our ability to engineer antibodies and to make sure that we get the best possible antibody to address the target. I think EVENITY is one illustration of that. BIMZELX is another illustration of that. It's not just that you need to identify the target to potentially translate that into a strong medicine. You need to engineer an antibody that creates the affinity and creates the ability to interact with the system.
So multispecific, I think, will be not only just for one disease, but for a lot of different autoimmune diseases will be a way to go. Now, having said that, once again, it's not necessary that by combining two that you treat only one disease. So we have with galvokimig and donzakimig, we have the first clinical study has been done in atopic dermatitis. It doesn't mean that the two drugs will be developed in this indication. Indications have been chosen because of the ability to execute the potential affinity and knowledge of the targets and the potential differentiation. And I think what you have seen with galvo, first set of data demonstrates this ability that there is still an unmet medical need and there is still value for differentiation and value for the patient.
In a nutshell, we have here another illustration of what we have been able to do with BIMZELX. The target was well known. The IL-17 role in psoriasis was well known, but the combination of A plus F was not done and was able to be translated into added value for the patient. It's what we aim with this bispecific. It's delivering more than what is currently available by just targeting one pathway. Galvo is 13 plus 17A and F, so here, the objective is to get the synergies of the interleukin on inflammation. Donzakimig is 13 plus 22, and here, it's a different type of combination. It's the classical inflammation on one side.
And on the other side is the ability to target the skin and making sure that we can restore the skin barrier, which is such an important element of the morbidity in the case of atopic dermatitis, for example. But to complete the answer to your question, for the time being, we are looking at the data in this indication. We are evaluating the strength of the data that we have and the potential other indication where these different types of combinations may create the best possible value for the patient. And then we will evaluate the ability to execute, the speed by which we can get, and the level of unmet patients' need before deciding which indication for which patients and for which asset.
You mentioned bepranemab as well, the anti-tau. Different sort of risk profile, I would say, in Alzheimer's. So how do you think about managing that risk in terms of that asset? We've seen some Phase II data with some signals there. When you're allocating capital between the things, how do you think about it?
On the capital allocation question, I think even when you focus on innovation, you need to profile your allocation of resources in a way that maximizes the long term of the company. Based on that, it will not be reasonable to dedicate 100% of your budget of research on identifications of new targets and potentially translating that into new mechanism. Because new mechanism, it's great. It's high risk, high reward. We feel that you should dedicate a certain amount of your portfolio on these types of assets, but not all. 25%-30% is fair. Certainly not 80% or 90% would put the company at too much risk. This is what we have with bepranemab. With bepranemab, we wanted to leverage our knowledge of biology by identifications of a new target, an anti-tau. There is no anti-tau on the market today for Alzheimer's disease.
At the very early stage, we were able to reproduce what other anti-tau could have done and try to connect that with the epitope where we feel there was the highest probability of success to translate the binding of the antibody on the target to a clinical outcome. So we are not surprised to see how the other anti-tau results unfold because we knew that they were not binding at the right position in the right place. And we have confirmation of that in the Phase II. Because in the Phase II, we have been able to have some signals. And we think we have a signal in the Phase II where we can see improvement for the patient. Now, for the next phase, we need two things.
We need to define what is the population which will at best improve or increase the probability of success and the magnitude of the outcome. And two, we need to define at what stage of the disease we have a higher likelihood of delivering this. So there is an element of patient profile and an element of timing of the disease. But it's still a very high risk. And so, as you know, when you have a high risk in your portfolio like that, basically, you can also think about partnering. Because partnering is a way to either develop capabilities where you don't, get the skill where you don't have, or share the risks that you don't want to do by yourself. Because by sharing the risk, it gives you space to do other things. So this is what we are exploring today.
Maybe one last pipeline question in this area. Dapirolizumab pegol, you had a full successful Phase III trial with your partner, Biogen. How's the next Phase III? You need another Phase III, I think, to get to market. How's that going?
Yes. We needed and we had a lot of discussion with the FDA on this topic. And the outcome was we needed a second Phase III. And I guess the reason was we needed sufficient patient exposure to get an ability to evaluate particularly the safety of the drug on a sufficient scale for the FDA to be comfortable to have a regulatory pathway. So this is what we are doing. I think if you ask me, I think that in the future, real-world evidence would be able to cover what is needed to be covered right now. But we are not yet there in this phase. So we are still in the phase of doing another Phase III with our partner, Biogen. We are very optimistic and positive because, once again, we have done one already and we know the result and what the result is.
So we are quite confident that we will be able to confirm in the second Phase III. And the first Phase III doesn't have a signal of a safety element, which you may remember, but was sometimes the case with an anti-CD40 ligand. So with an anti-CD40 ligand. So so far, we are in a very good position. We need to do the second Phase III. We are doing the second Phase III. We are very bullish on the product because we feel that with the result we have been able to achieve with the first Phase III, there is a huge unmet patient need there also. And the market in lupus, I don't feel has got the development that was needed. And a lot of patients are not really treated at the level of quality which is required for them. So they are expecting something else.
I think the market will grow when we will be able to put on the market a product that can help the patient. And certainly, the market size will grow. I don't think that the current solutions available on the market are sufficient to accelerate the market growth and help the market to mature. I think dapirolizumab will be a product that will do that. And so we are really looking forward to the launch of this product.
We've talked through a number of late-stage pipeline assets and mid-stage, or pretty late actually, with galvo and donzer as well. You highlighted on the slides the long LOE time to 2037, 2035 for some of the assets. So what do you think you need to allocate capital outside of your R&D budget, outside of the late stage? What are you thinking about the growth and preparing for that longer-term period?
Yeah, so first thing first, for a company like UCB, if you want to be successful for the long term, the only way to do it, in my perspective, is to be able to have a discovery engine which is at the best of the hearts and the best of the industry, so focusing on research, focusing on the ability to better understand human biology. I mean, I mentioned that in the slide, but it's really the heart of UCB, and as long as we are doing that the right way, the rest is possible. If you don't have this, you may have best for the rest, but it's more difficult.
So in terms of capital allocation, think about that in the near future, that we're continuously looking at how we need to be connected to science, to the evolution of the pipeline and the platforms in the environments to make sure that we can integrate, collaborate, partner in order to build an engine that increases the probability of success, of better understanding human biology, and translate that into scientific hypotheses. So it starts with AI, but it starts also with immune research for immunology, better understanding neurodegeneration, better understanding blood-brain barrier. So all of these components, if you look at the evaluation and the evolution of the science, you can feel and see that science is booming right now. And it will be very unreasonable to stay and to stick just on what we are doing now and hoping that we will continue to provide innovation for the future.
So the first thing is a discovery engine and continue to build the state of the art, leveraging what the science and the environment is creating today. Two, as I said, growth on the long term, it's organic and inorganic. In our five growth drivers today, we have organic products that we have discovered and we have also products that we have acquired. Acquisition for commercial products has been in the past focusing on strengthening the pillars that we had and the therapeutic area that we had because we didn't want to increase our OpEx, our P&L, by additional new therapeutic areas. But with the growth driver that we have today, adding a commercial asset now will be too early. So we have time. And so for the short term, it's probably more early stage that you need to think about us from capital allocation. So research, platform, early stage.
And then moving forward, when we get closer to the end of this decade, we will probably be looking at what's next. But as I said, we have a very strong balance sheet. We have a strong financial situation. So we have everything in our hands to be able to leverage these resource allocations and capital allocations in the best possible way. We have never been in this situation, at least for many years. And so now we are really in a very good place there.
Any questions from the room? Then I think we're probably at the end of our time. Thank you very much for the chat.
Thank you, Richard.
Thanks, everyone.