Morning, everyone. Hope this is on. Hope you can hear me okay. Welcome to, I think the last session before lunch. I am Charlie Haywood from the Bank of America European Pharma Team. My pleasure to be hosting Sandrine Dufour, UCB CFO. Welcome. Thank you for joining us today. I think that is our big picture. Any sort of opening intro remarks? How are we feeling about things? Obviously, good start to the year.
Yeah.
Lots of interesting stuff coming up, which I am sure we will get into.
I am sure, yeah. No, and thanks. Happy to start with just the big picture. As you know, UCB is on this 10-year growth trajectory, and I think what makes UCB quite unique is that we have more than 10 years of exclusivity with our largest growth driver, which is BIMZELX. You have seen, talking about recent trends, that building on last year's growth, we have put out H1 numbers, which were quite strong for the first half. 27% growth net sales, very strong EBITDA growth, margin expansion.
We have also upgraded the financial guidance for the year, and we also came with revised peak sales expectations for BIMZELX at at least EUR 7 billion. So, very nice start of this year. I think the other part that we also really focused on is to work on shaping the future growth beyond the current commercial growth.
We continue to invest in innovation, come up with establishing further differentiations of our assets, and we were very pleased with the BE BOLD study, on BIMZELX that is establishing the superiority of BIMZELX over SKYRIZI, and also very strong safety profile. Beyond that, you have seen us moving also external acquisition with Neurona and Candid, and there again, it is about further innovating and bringing potentially disruptive medicines both in the epilepsy side with Neurona, which is addressing a quite severe epilepsy domain, but also potentially changing the immunology paradigm with T-cell engagers with Candid. So that really has been the intense focus during the first half of the year, to come up with potential growth drivers beyond the current commercial portfolio growth.
Got it. No, that is very clear. As you look at your pipeline as it sits, are there any assets you would call out specifically, like one or two assets particularly exciting, and any data points that is worth the market tracking in the next couple of years?
Yeah, it is always difficult to pick up one side when you look at the pipeline. But if I take it from my point of view, and again, it is not total management, it is really my point of view, I tend to look at what has the biggest potential because I am focusing on establishing long-term sustainable growth. Of course, having in our hands galvokimig on the one side, that comes with multiple indication, which is the multispecific, that we announced, by the way, yesterday that we are having enrolled faster the atopic dermatitis clinical trial.
On the other side, the acquisition we have done with Candid, which brings early assets, cizutamig, that has the potential to bring free drug remission and shape the next phase of immunology and also capturing large potential of autoimmune disease. These two assets, they can certainly if things, of course, it is early stage, but if they are progressing, they have the potential to help us establish long-term growth, so growth beyond growth. That is why I pay particular attention to this. Now, I could have answered you, Neurona is very innovative treatment in the domain of epilepsy, but you asked for two, so
Got it. As you look at your current sort of BD strategy, how would you You have obviously done two mega deals since we last properly spoke, but two big deals or two decent-sized deals going forward, you look into more early stage, anything sort of later stage, clinical, commercial? What is your current further BD appetite as we think about the various-
What we said is that we would focus more on early stage of the pipeline, to think about the long-term potential. Specifically because if you look at the current pipeline we have, as of, I would say end of 2027, with the galvokimig data and atopic dermatitis, and then on the next years, we will have a lot of data readouts.
That will tell us what is in our hands and potentially the need for investing behind the pipeline we have. Also the fact that we have very good visibility in mid next decade with our current commercial portfolio. These two elements do not push us to go for late stage at this point and more earlier stage. Then, of course, when we have these readouts that will shape the next phase of our potential inorganic approach.
Got it. I think the galvokimig phase II-B data end of next year now, that will be fairly sort of gating of how you are thinking about-
Yeah. This and-
Further investing in that-
This and other results coming at that period of time. Yeah.
Okay. Got it. That is very clear. Then wanted to move on to BIMZELX. I think just in starting high level, basically sort of feedback sentiment, how you are feeling about growth trends, et c. Just sort of what is top of mind for you, and then we will go to a few questions.
Yeah. So I think the BE BOLD data, we are really coming with, for the first time, the ability to establish the superiority of SKYRIZI in the joints and very strong safety profile. And for us to communicate about this with rheumatologists, but not just rheumatologists, also dermatologists. This is clearly something that continue to establish the differentiation of BIMZELX. We have now a body of evidence of efficacy and also the efficacy in duration.
So we have five years data now in PSO, four year in PsA, three year in HS. And clearly we have progressed as well in terms of our access. That speaks to the differentiation of the profile. We are growing our impact on HS, and HS, as you know, is a market where we need to continue to work on elevating the awareness because it takes a very long time for patients to be treated.
But all of that goes in the same direction. The consistency of the data of BIMZELX, the real-world evidence that we have and the feedback, the very homogeneous feedback we get from all physicians around the world. And that gives us the confidence behind BIMZELX potential. And we do see this translated in the continued growth of our volumes throughout the various geographies.
Got it. That is very clear. On your guide that you gave at 1H the EUR 7 billion guide, I think you sort of have not given too much in terms of contribution.
At least EUR 7 billion.
At least EUR 7 billion.
I insist on that.
At least EUR 7 billion. You haven't given too much in terms of the specific contributors within that. I know you historically always said psoriasis was your largest indication. Is it fair to think HS is now not dissimilar from psoriasis? Then second point is the timing of the guide was interesting. I guess, what prompted you to give it at 1H results?
Yeah. So, maybe I'll start with the second part, where I think, we were waiting for BE BOLD results. So there was a set of assumptions in our internal model, but getting the BE BOLD result that gave us the confidence that I was expressing before, I think was an important moment for us to move ahead. All the other factors that I've mentioned, the launch in HS, the potential there, the fact that we are confident that we'll continue to work on elevating the awareness, the potential of this market, which is still being shaped.
We started with much lower prevalence, and as we move, we see that we're talking about 1% prevalence in this disease. So all of these were building on the overall confidence added to the data we have. Then, we are also continuing to invest in life cycle in BIMZELX with our PPP, which is another smaller indication, but we are convinced that it will help also on the halo effect that new indication can have. Also in adolescents, we are also exploring developing the adolescent. So all of that together and the traction that we're getting gave us the confidence to come up and share the new revised at least EUR 7 billion peak sales. Remember the context we were in when we put the first guidance of BIMZELX.
I was sitting in these rooms with people telling me we would never do more than EUR 500 million in BIMZELX. So we came out with this number, and at some point, the more we were moving, we thought that we were not credible enough with the last guidance we got. That prompted the change. Now to your earlier question on how do we see the contributions per indication. So considering the size of the PSO market, we still see this as your lead indication overall. But to your point, HS certainly would come as a solid number two in terms of our relative weight.
That's very clear. Is PPP and the adolescent trials, were they included in there as a base case? They included risk-adjusted within the EUR 7 billion or have you not-
It is included, yeah.
Got it. On your 1H call, you're very calm. You got incremental access with one of the large U.S. PBMs, and I think a big investor debate and question we've had is obviously, prescription data since then, the volumes that you can see. Obviously, there was maybe some summary influence, et c. How are you feeling about life since you've got that incremental access? How are your conversations? Were you expecting a quick ramp, slow ramp? Will it moving parts on the volume uptake, given that?
Yeah. In terms of access, maybe just stepping back a bit on access, because I think it's a very important strategic topic there. From the very beginning, we've said that we wanted to progressively move on access. There was no point for us to rush in and investing in very high rebates and earlier lines formulary position at a time when BIMZELX was not experienced and in the hands of physicians. We've progressed, and honestly, if I look at analog, we've been able to gain fairly fast, a very large access, 80% coverage in commercial contracts and a vast majority of Medicare and Medicaid.
In June this year, we continued on this strategy of steady progress, and we gained our first-line access, with one of the large PBM, moving from a double-step position to a first. What that does is that it opens a much larger eligible pool of patients that all have to step through and can be immediately available first line. That comes to your point with higher rebates. What you see is our strategy then is to make sure that we push through as fast as possible and in the boundaries of this contract, make sure that we gain market share so that it becomes as fast as possible accretive to growth.
We are very pleased with what we have seen in the boundaries of this contract since June 1st in terms of how fast we were able to gain share in the coverage of this large PBM. So that is effective. I honestly also see that we are improving to do that. Because what it takes is that you need to be targeted. You need to assess where are the physicians and the potential patients which are covered by these payers and to address them. I think we have really done a nice job of having a much more targeted approach to make sure that we are going through an accelerated gain momentum in this contract.
Got it. That is very clear. I guess, looking at IQVIA U.S. script data, it looked like you are flat for 10, 11 weeks after you gained the access. I know this is obviously a very short time, but some people were expecting a quick uptick in acceleration or whatever, and it looked like you did not necessarily get that. If you are gaining share within the contract, is there something else where, was there some summer impact? Was there some other impact in other contracts, or have you got sort of any specific comment to that then?
I tend to look at it relative. First, I am not looking at every week. I look at average because there is peak and trough, there is whatever holidays and seasonality, or you name it. But then I also look at relative performance, not just us in absolute, but what others are doing. Honestly, we have been, I think more than 9,000 scripts for many weeks now, so we do see that we are progressing. If I look at where we were at the beginning of the year and we were on track with our trajectory.
Got it. When you say well on track with trajectory, I know sort of, I know on the Folio article you said you are comfortable with where consensus was. I think consensus has not moved that much. Have you given any updated commentary around
I repeat, I am comfortable where the consensus is of EUR 3.2 billion for BIMZELX this year.
Got it. That is very clear. The data we were looking at, I think the August, there was a report that August TV spend, BIMZELX was the highest drug TV spend of any company, any drug.
Oh.
That was reported. Trying to understand, was that proactive? Was that reactive in any way? Was that base case? How should we think about that? Because it feels like a step change from prior.
Well, first, we are now quite experienced in direct consumer investments, advertising campaign. We started this in 2024, with good established return as well. It is really something that is clearly well thought through in terms of our calibrating the spend, in terms of the expected return, and in terms of looking at our relative share of voice. We see that there is still for us, a real potential to elevate the awareness. You need to target multiple channels. Here it is free to speak to potential patients. We are supporting this through all indications.
Of course, with BIMZELX there is something for us new to voice. With HS, remember, there is such an amount of patients who are not aware that there are treatments or even of their disease or even putting a name of the disease that they have. The return of investing behind this is really significant because the demand is there. How to stimulate this demand so that it triggers awareness, attention, share of voice, so that then patient goes through their healthcare journey, meets with their physician, and that turns into prescriptions. I am very demanding in terms of how we allocate our resources and look at the expected return.
When we do that, we do this with the very high comfort that it is going to be accretive on growth and generating a return which is very good. That is why we keep investing. It is something that today we also constantly assess whether what is the right balance. Because we are at the beginning of our journey, we think the potential is there. For us, as long as the return is there, we continue to push and support the potential growth. The objective is really to maximize what we have in our hands and with the building of evidence, the efficacy, where we are, that is really pushing the growth with BIMZELX.
Got it. Okay. It is fair to think of, obviously it is only one data point, but I think UCB currently has some sort of spending data points in terms of TV spend or et c. It is fair to think that this was a targeted time where people are coming out to summer, and it was sort of strategically an interesting time rather than reacting to anything that you are seeing in terms of trends or prescriptions.
Yeah, absolutely.
Got it. That is very clear. On 2026, I think it depends on how you do the math. Obviously, the biggest unknown for us is the price cut that you took and sort of the impact of that. Is it fair to assume to reach your guide, to reach the numbers that you would expect some script acceleration to get there? Or what sort of trajectory were you expecting-
Yeah.
...within that?
I do not call it a price cut. It is not something where you cut the price. It is an access strategy that translates into a change in positioning on your formulary that translates into an evolution of your mix. I think it is very important to invest in access, and access comes with different level of price, but it is not as if there is a price cut. It is a different positioning in the formulary. What is important also to get is that there are various channels today. We have mentioned the one where there is a PBM with a certain level of first line.
As you know, we still have a proportion of the patients which are going through medical exception, and they come with 100% price. The channel mix translation is what drives the evolution of the price. Now, we expect the investment in access should translate and is translating into a growth of volumes, which will deliver on the expected total revenue that we said we were comfortable with, the EUR 3.2 billion in consensus. Clearly, this is the plan and this is what we are executing there.
Got it. That's clear. Then just on, I think one of your PBMs is still being blocked on the HS access side, which obviously is driving the unrebased volumes. I think there's certainly some risk that the company that's blocking or parts of the blocking has upcoming competition coming and might launch next year in that setting with a new drug, and therefore might want to keep fairly exclusive access on the contract. How do you assess that risk, and do you want to get access to that contract before then?
What strikes us today is the proportion of medical exceptions still in HS, which speaks to the fact that BIMZELX is the most efficacious to the point where physicians are able to take the hurdle it is in the U.S. to get through and have the drugs and the treatments in the hands of the patients. That's why access is a strategy, but at some point, it's not in our hands to say we need to look at the benefits of conceding high rebates to gain volumes and does it make sense or not. Today, apparently someone's giving much more money, but we still see that there's very good traction in our current trajectory.
Then to the competitive profile of what's coming, we have built a certain duration of real-world evidence in HS. As you know, because it's a progressive disease that can get more severe, it's very important to come with certain years of data. Let's see what competition comes up with. Today, the standard, the efficacy is there. We know it's heterogeneous, so it's good that new modes of action comes and help us elevate the awareness so that there's more patients who are aware of the disease.
But we will see what data are coming from this competitive asset. One thing is to have access, but the other is almost ethical responsibility of a physician to put patient late on a treatment that then leads to irreversible tunnels and affection that then goes to surgery. Do you want to put a patient on the less efficacious drug when you know where that leads you is a key question.
That's very clear. I did want to touch on competition quickly because, last time we were waiting for the main late data, which ended up all right for you. But in terms of your guide, EUR 7 billion, how much of that. Obviously competition's coming. You don't know how they'll play out. I think you've got strong rebuttals, and we're a strong believer in your data. But how much in that guide is reflective of potential HS competition over time?
Well, we aim at leadership position in HS, and that's the assumption. We think that the market potential is there and that we have enough longevity of data as well and a position when competition is not coming tomorrow there as well, and still needs to establish, where they are in terms of efficacy, safety. Safety matters as well.
If you look at the fact that these patients potentially can end up in surgery and the fact that dermatologists are quite conservative, things in labels such as bleeding or bruising can be element that they may think twice before electing this type of treatment. So I think we've put out data where after three years on HS, 86% of patients are still seeing efficacy and improving efficacy. So that's the strength of the data that needs to be coming at par or being beaten, and that's why we're very confident.
Got it. Last one on competition BIMZELX. I guess from your seat, we'll see how data plays out in terms of competition, see how that looks. From your seat, from the UCB side, how should we expect you to react as such? What can you do from your seat? Is this heavier DTC? Is it spending down the line? Is it some sort of heavier pricing, better access? What's your sort of potential rebuttal if competition plays out?
Back to what we were saying, I think investing now is important. There is a window we are not talking about. Before any competitor comes with the same body of evidence, there is time. But now is the window really to supporting and establishing the awareness and creating this real-world evidence and continuing as well to come up with more data. Data that the IL-17A/ F. The F plays a key role in that.
So continuing to invest in the scientific understanding of the biology, the longevity of the data, that is really what we will continue to do before even competition comes on the market. Anyone that is going to invest behind awareness will help grow the market. One of the lever is not just market share, but it is the fact if we are able to move the time of diagnostic from 7- 10 years where it is today, much earlier, this is the more eligible pool of patient that will benefit all payers as well.
Got it. That is clear. Then I wanted to touch on 2027, just sort of moving parts from where you sit, obviously. I guess, what would you call out in terms of 2027 moving parts or the street, the market to be aware of? Then I think sort of guide philosophy, typically, you have been sort of, I think historically BIMZELX, there are some very big moving parts in terms of pricing, volumes, et c. You are obviously now at the stage where there is a reasonable amount more certainty or conviction, I would imagine, in volume growth. So how are you thinking of guide philosophy given BIMZELX and dynamics there as well?
As you know, we will come in February with our guidance on 2027. But a bit of months between today and February. But overall, one thing one should not forget is BRIVIACT LOE, which started this year, but of course, the effect will be also visible still in 2027. That is on the adverse. Then we aim to continue to push the growth of our five growth drivers, BIMZELX being the largest one. I do not think in 2027 we are yet in a cruising altitude in terms of the mix.
I insist on this because the volume price combination is also where the volume is breaking down in terms of channels, has an impact on the range of potential net price. 2027, we are not yet at a point where we have completely gone through a very stable mix. This can create still some, I would say, range of outcomes, may I say so, a bit like in 2026, in fact.
We'll see where we are. Of course, the exit in 2026 will help us inform better for 2027. For sure, we'll keep aiming at continuing to grow the assets, confidence in the volume, get the data, and with the DTC, with BE BOLD, we have enough behind to create this volume continued growth next year that will help position the guidance on the continuous growth trajectory.
Got it. That's clear. I mean, I don't know if you've— I think consensus gets to a 37% EBITDA margin next year. Obviously, you're talking to continued leverage from BIMZELX side of things. Just wonder if there's any thoughts on that, if you think any of the cost lines, any of the recent deals are well reflected or if that is a reasonable scenario of where you could look.
Yeah. I will not comment on your consensus next year, but directionally, what we set for the mid to long term is that we aim to continue the growth top line, bottom line, and also we have room to further expand margin. Of course, if you look at where we've come from the margin, we've been able to gain significant uplift in margin towards more in line with peers. But with operating leverage ahead, there's still room for further expanding the margin.
Now, 2027, we looked at what's coming with, on the one side is the BRIVIACT LOE, on the other is the impact of the acquisition. But overall, if I look at the R&D expenses, we said that intentionally, we intend to invest around 25% of our top line in R&D. That gives you an idea of where to position the investment. That's really the core of our strategy to invest in innovation. That's why it's something that we indicate that you have this in mind on our innovation strategic approach.
Got it. Last one on this, I think you've alluded to this already, but it's sounding like your exit rates will be almost the most important guide of how you should think about 2027 in terms of from what we've discussed earlier, BIMZELX was a bit soft in the summer. It usually is. You've got the better access that should start to play through. As the market, should we look at your script rate and exit of out to the end of the year as the best proxy of how to think about volume into next year?
Well, of course, where you end the year is the beginning of next year. That's helping giving you a view on volume, price, mix, and that's a good way to. That's helping shaping what 2027 can look like.
Got it. I forgot to ask, actually, any more questions on BIMZELX or 2027? No, I think we're good. I wanted to jump to galvokimig, actually. The phase II obviously recruited quickly. Now data's coming end of 2027. I think there's definitely an investor perception that the asset could be accelerated quicker potentially, how you could read out at the 16-week, which is the primary endpoint versus the 52-week pill data we're seeing.
[Retatrutide] got triple agonist that's gone straight to phase III. It's a competitive space. Your differentiation, I believe you still frame as efficacy, not dosing. How are you thinking about that program? Is there anything that would make you decide to go quicker to phase III or are you happy with your current timeline?
I think we're pleased with how we approach it, because what we want to establish, to your point, is really differentiation and the space in that domain to build on the existing standard of care. What we bring is an asset that captures a broader biology. We are aiming at Th2 and Th17 inflammatory pathways here. Running a phase II will allow us to get some 52 weeks data, and in a disease which is progressing, it's important to have this.
We did the first one in IV. Now it's going to be subcutaneous. Then dose ranging, which is very important as well. All of this is important for us to design the best phase III, and that's why we prefer to continue on our history of very high success rates of phase III. 86% success rate in phase III. We are consistent with how we have approached this. We do not intend to release the 16-week data because of IP issue as well.
Okay. Interesting. The end study will remain blinded post the 16 weeks?
Decided for two years on, yes.
Got it. How are you feeling about the. Obviously, you have got two respiratory signal seeking studies you started. How should we think about the next step for galvokimig? Could you start further proof of concept trials ahead of those reading outs or are you waiting for the initial phase II-B to read out and then see how the asset looks? I think I am more coming from the asset looks potentially very exciting, but you are going into a market which is getting increasingly competitive across some of the indications. Speed to market-
Yeah.
...matters as well.
We answer it in a way. I think even the science is preliminary. This is quite new. For us, it's good to have the evidence on these before making new decisions. We'll see what we have.
Got it. On Neurona, just because I get asked, is there any chance you could file the data in 2027 given the sort of pathway filing you have? I think you've got FDA RMAT designation. Is there any potential for an early file from that data?
Let's see. We must finish it phase III next year.
Okay. So no path from the phase II based on designation.
No
Got it. That is very clear. Then on doxecitine, I just wonder, obviously you will be sort of in the launch of that, feedback so far, how should the marketing campaigns have launched into next year? What are the moving parts there?
Yeah. First, it is a very ultra-rare, as you know, and it was approved and launched in the U.S. It is basically saving life of kids. So it is a treatment where we started before the access and giving the drugs, and now we are moving to pain. It is going well, actually, but it is fairly small in the overall portfolio. But considering the impact it has, it is clearly something that is getting us some traction in the ultra-rare segments where we bring it. So good start.
Got it. Then one bigger picture one, obviously, you talked your decade of growth. Should we read that as ambition to grow every year out to 2035 or is this, is that the correct read?
Well, they are analog of the shape of the growth. As you know, many times peak phase is achieved, not the last year. So far we do not see difference, which means that the shape of the growth might not be necessarily linear towards 2035, but it is fairly early, so let us see what else can we do with time to work on the shape of the growth.
Got it. That is clear. Actually, I moved up in the decks, but I had more questions there, so I will jump back. Just sort of HS markets. How are you feeling about sort of latest dynamics, your sort of mid-teens growth, ambition, market outlook, et c? Are you seeing any sort of uptick, any change in diagnosis rates, anything you are seeing changing there?
Yeah. Well, we continue to grow. It is interesting to look at different markets here because that shows the difference, how access can have an impact. In geographies where access is the same throughout the country, we see that we are really already leading. That gives us the confidence that if you think about the efficacy and the impact, that justifies the confidence we have in our ability to lead in the space. But back to what we were discussing before, we are restricted with one PBM. We still are surprised to see the rates of medical exception in HS. All of that gives us the confidence that we will establish the leadership in that space.
Got it. Actually, on that medical exception, on those volumes, I think that obviously grew slower in 1H than it had done in 2025, for example. If you do not get access to that contract, how should we think about those volumes? Do you imagine they will be increasingly restricted through that contract or are we at a level where they are sort of stabilized fairly well?
We started in 2025 where we were surprised because they were not that restricted. Then at some point, it probably hits the payer in terms of having to reimburse full price. It is visible on their financials. They were a bit more demanding at closing the door, if I may say so, but I was expecting to see a faster decrease than what we have seen. There is still a portion of medical exception that goes through, which shows that if I translate this in the benefits for patients, because it is so efficacious, physicians are ready to really go through the process and make sure that in the end, patients ends up on this treatment.
That is clear. Then, sorry, just going through my main incoming. Pricing into 2027 for BIMZELX. What moving parts should we consider? Obviously, we are going to be lapping the year where you had the concession that you gave for the contract. What are the big moving parts to think of? Is it fair for the market to assume what you have done at 1H , to assume there will be some incremental access coming at some point? As the direction of travel said, what are the moving parts where you lag into 2027?
The two moving parts we have discussed, it is this progress in access that comes with our investment in price. That takes time to go through the established base and the growing volume. The other one is what we have just discussed. At some point, if we improve coverage, you translate your medical exceptions into patients which are covered. This mixed dimension, that is why I talk about channel mix. This mixed evolution drives an average net price evolution.
That is the dynamic you should see next year. I think, if you remember last year, we were talking a lot about the bridge program. We still have this bridge because it is making sure that we ease the access to patient, but this has been more stabilized in terms of our use. We still have this program, which we think is important, but in terms of variation over time, we think it is fairly stabilized.
Okay. Got it. Yeah. That is clear. The one that does not come up as much, I am just wondering if there is any sort of major moving parts to consider is ex U.S. BIMZELX as we go through second half this year into next year. It builds its smaller moving parts in general, continue good growth. Is there anything we should consider there or worth factoring in?
We continue to see a very good momentum in terms of growth in the various geographies we are. Interesting to see that the latest country we have launched into because of more data, specifically ZILBRYSQ, etc, we are positioning it in the entire IL, not just IL-17, but IL-17 and IL-23, because we are able to come with superior data versus SKYRIZI. We see that we benefit from this body of evidence that helps us positioning in terms of market share, and that is clear on the latest country we have launched into the market. That is good dynamics.
Got it. Are there further country launches to be considering?
Right now it is getting marginal, but we have not launched all indications in all markets. We continue to gradually roll this out in Taiwan, Brazil, etc. There is any given markets where we still have potential to get coverage and launch.
Got it. That is very clear. I think we are just up on time. Sandrine, thank you very much for joining us.
Thank you.
Thank you everyone for coming.
Thank you.
Enjoy the rest of the day.