UCB S.A.

Welcome to the UCB Full Year 2025 Capital Markets Call. My name is Antje, and I'm doing Investor Relations at UCB.

Before I introduce you to the agenda and hand over to the speakers today, I have some remarks. This video is being recorded.

You can find the presentation in our download center, if you dial in by the phone. The presentation and the following Q&A session are intended for institutional capital market participants only.

If you're not, please disconnect now. This presentation and the following Q&A session are covered by the disclaimer and safe harbor statement as stated on Slide 2 of the slide deck.

Kindly read this carefully. With this, I'd like you to introduce you to our speakers today: Jean-Christophe Tellier, our CEO; Emmanuel Caeymaex, Head of Patient Evidence; Fiona du Monceau, our Chief Commercial Officer; Sandrine Dufour, our CFO; and this will then be followed by a Q&A session with all presenters.

Thank you. Jean-Christophe, over to you.

Thank you, Antje, and good morning, good afternoon, good evening, everyone, and thank you for joining our full year 2025 presentation. It is really with great pleasure that with my colleagues, we will share with you our results of what has been a very strong year.

Can we move to the next slide, please? Because, as you know, we are focusing on execution of our launches, and I think it's fair to say that 2025 has demonstrated our ability to continue to deliver strong growth based on our 5 growth drivers that we have, and thanks to them, they will allow us to enter and continue to build our decade of growth.

If I want you to keep just a few elements out of this slide, I will start on the top left part by just one number. Our net sales growth versus last year at constant trend has been at plus 35%.

How we have been able to deliver this growth? It's in the arrow of the middle.

And as you can see, our 5 growth drivers have reached EUR 3.3 billion, which is more than a double of the revenue that these products have delivered last year. Bimekizumab only delivered and achieved more than EUR 2.2 billion in 2025.

So as you can see, a very strong growth that has been delivered in 2025, and Sandrine will be able to go further into the P&L. But a few highlights maybe on my side about 2025.

On top of this delivery of the growth and the growth drivers that we have, we have seen also some critical advancements in our pipeline, and that's the bottom line of the slide. First, KYGEVVI.

We achieved approval in the U.S., and we have a positive advice from the CHMP from Europe. As you know, KYGEVVI is active in an ultra-rare disease, TK2 deficiency.

And it is the only -- first and only treatment that would be available for these children and family to save their life and help them to have a better life. The second element in '25 was our bispecific.

We have 2 of them in atopic dermatitis, donzakimig and galvokimig. Both of them have achieved positive endpoints -- the primary endpoint.

But through a rigorous analysis, we have decided for the time now to focus on galvokimig and accelerate the development of these IL-13, IL-17 bispecific, not only in dermatology, but also into neurology. Then bepranemab, our anti-tau antibody in the Alzheimer's disease.

We have a positive Phase II. We have -- we think we have very strong insight that will help us to guide to develop this product for these patients.

And we have been pleased in February to receive a fast-track designation by the FDA. And finally, in '25, we have also started the development of BIMZELX in rare disease, but quite debilitating, which is the palmoplantar pustulosis.

'25 have seen also a decision, a very important and strategic decision for us, to make a significant investment in the U.S. with a total of $5 billion of direct and indirect investments into a mammalian manufacturing site to manufacture BIMZELX in the future from the U.S.

Next slide, please. So I think it's fair to say that the strong achievement that we have been able to realize in '25 guide us and promise us a bright and successful future for the decade of growth ahead.

The first reason of that is that we are one of the few companies who will have a long periods of exclusivity before the next wave of loss of exclusivity. As you can see on the top, we will start in 2033 and the last one will be BIMZELX in 2037.

This long period of exclusivity will give us the time and the space to really deliver on our growth. The second element that can also explain our confidence in the future is the ability to continue to differentiate our portfolio.

You remember that BIMZELX was the first product to be able to be launched with 3 clinical studies of superiority versus standard of care. As you know, we have started, a few years ago, one additional study in psoriatic arthritis, BE BOLD versus risankizumab.

We were expecting this result in the second half of 2026, but we are pleased to share with you that thanks to a very strong and fast recruitment, we will be able to get the result earlier already in the first half of this year. And we continue to grow our pipeline.

We'll have this year one submission, 6 Phase II -- 6 Phase III, 5 Phase II, as you can see here. And because of a strong balance sheet and particularly our ability to reduce our debt, we now, of course, have the space and the capacity to think about inorganic growth to continue to fuel, expand and accelerate our growth future.

So thank you again for participating to this call. And with this, I would like to hand over to Emmanuel.

Thank you very much, Jean-Christophe, and hello, everyone. It's a real pleasure to be able to provide you with an update on our pipeline from this new vantage point for me as Head of Patient Evidence.

So let me take you through innovating with purpose and how we translate differentiated science in durable growth. Our engine is robust, and it's focused on immunology and neurology and their intersection.

And today, I'll focus on galvokimig, FINTEPLA, our newly approved KYGEVVI after commenting on a few other key updates. So on the next slide, you can see our mid- and late-stage pipeline that's driven to -- that's built to drive medium- and long-term growth to diversify risk and deliver innovation and breakthrough aimed at high unmet need populations.

And just for ease, I'll start at the top with the BE BOLD study, which Jean-Christophe just mentioned. So it is strategically important in the sense that there is an opportunity in psoriatic arthritis to raise the standard of care.

And right now, the IL-17 A/F dual inhibition is not yet positioned as a first-line treatment and is not yet leading. Yet we believe, based on our Phase III results, that there is an opportunity to demonstrate superiority versus the IL-23 inhibitor, risankizumab, SKYRIZI.

And so we've powered the study to be able to achieve this using a pretty assertive and stringent endpoint, which is the ACR50 at week 16. And so provided this is successful, we'll have the opportunity to strengthen the positioning of BIMZELX across both rheumatology and dermatology, where many patients with concomitant psoriasis and psoriatic arthritis are treated.

And as mentioned earlier, the results are expected within the first half of this year. You also read that we started the palmoplantar pustulosis study.

And this actually is a disease that is largely IL-17F driven, and this will be an opportunity for us to continue to establish the leadership of bimekizumab in the IL-17-mediated diseases. Now for RYSTIGGO, rozanolixizumab, on the one hand, we have the MOG-antibody disease study readout in the second half of this year, and we're also very pleased to announce that we're starting a ocular myasthenia gravis Phase III study, recognizing the very good clinical performance of RYSTIGGO and the fact that most patients with generalized myasthenia gravis actually start with ocular symptoms, and so this is a logical thing to do to make sure that we enable symptoms to be tackled early and thereby prevent irreversible damage for patients with myasthenia gravis.

So looking forward to starting this study within this year. I'll briefly touch on FINTEPLA, fenfluramine, a little later.

I just wanted to say a word also about bepranemab. So we've been working very proactively and constructively with regulatory agencies, starting with the U.S.

FDA, who very recently gave us the fast-track designation for bepranemab in Alzheimer's disease. And so we're encouraged by the exchanges and the meaning of the data that we've been able to generate in our proof-of-concept study, in particular, in a subpopulation that was predefined.

And again, that data was pretty convincing across biology and also across cognition and functional endpoints. So looking forward to more with bepranemab.

And then finally, galvokimig. So Jean-Christophe mentioned, we're starting 2 studies in respiratory diseases.

And we have started the Phase IIb study in atopic dermatitis, and that's a 52-week study, which will report results by 2028. Now if we move to the next slide, we can dive a little deeper into galvokimig.

First, recognizing the fact that in atopic dermatitis, the results were pretty strong. And actually, this molecule was designed to tackle the heterogeneity of atopic dermatitis, delivered about 50% EC90 at week 12 and also very good pruritus data, each data.

So the differentiated potential is there, which we will now test in this Phase IIb and really seek to define the optimal dosing. Now what's new and what you haven't heard before is the foray that we're planning in COPD and in bronchiectasis, non-cystic fibrosis bronchiectasis.

So COPD has a massive unmet need, as many of you know, it's very prevalent. It causes 3 million deaths per year.

So the burden of disease is really very, very high. And it is entering a precision immunology decade.

So in this sense, respiratory is trailing dermatology and rheumatology. But I think that the translation of biology is now happening.

And with galvokimig, we have an agent that, through its combinatorial approach, really has the potential to addressing core mechanisms of disease in both COPD and non-cystic fibrosis bronchiectasis. So in COPD, you're aware that some products were approved and the segment of patients that are so-called high eosinophils, they're served to an extent, but that's only about 30% of the population.

And the other 70% really don't have an approved treatment or targeted treatment to go to today. And we do know that whilst the IL-13 inhibition is presenting a solution that other group probably needs a therapy that takes care of neutrophil-driven inflammation.

And that is the concept we're going to test in quite a large study that is going to start this year. Bronchiectasis is not as well known, but it's a disease which is chronic, is very debilitating, chronically diluted bronchi.

With the advent of DPP1 inhibitors, there is a level of proof that addressing neutrophilic inflammation can have an impact, and we're talking about a 20% reduction in exacerbations in patients that have at least 2 exacerbations per year. So you see there's still a lot of headroom.

And we do know that the pathobiology centers on neutrophilic inflammation, but also mucus dysfunction. And so that's offering validated targets for us and a target which by inhibiting both IL-13 and IL-17, we should be able to meet.

So we look forward to those 2 studies producing results. We certainly feel that the scientific rationale is very credible that in each case, one of the pathways is somewhat derisked and that the science underlying the second pathway in each disease is now well established.

So together, this represents a very significant opportunity for galvokimig. Now let's move forward to neurology and to FINTEPLA.

So as you know, FINTEPLA has been really focused on developmental and epileptic encephalopathies. You learned last year that in CDD, which is an ultra-rare genetic DEE that FINTEPLA has had very nice results, which now will enable us to submit a file to the regulators for approval, hopefully rapid approval given the enormous unmet need here.

The news for today is that we're taking FINTEPLA into neurodevelopmental disorders and in particular, RETT Syndrome. So Rett syndrome is a disease with a profound unmet need.

And the mechanism of action of FINTEPLA should be able to address that unmet need beyond the seizures. And so we're looking forward to initiating this Phase III, which is based on clinical observations and credible mechanistic hypothesis.

We're looking forward to starting this in the next few months. So FINTEPLA, with no generic until 2033, is representing quite a big opportunity for impacting patients, but also for UCB value creation.

So on to the next slide. And then to close KYGEVVI, where we just received FDA approval and CHMP nod.

So KYGEVVI is the first and only approved treatment for adult and pediatric patients with TK2D deficiency. This is for patients that developed the disease age 12 or below.

It is the first foray for UCB in ultra-rare diseases. It's a mitochondrial disease, and so we look forward to learning in this space and establishing capabilities.

So we're ready for an agile commercial launch that's planned in the first quarter of 2026 in the U.S. first.

So as you see, the number of diagnosed patients worldwide today is probably around 1,500. So there's probably still some space to go to identify patients.

However, many patients are already benefiting from KYGEVVI through our development program or in other ways. And so we look forward to expanding that over the next few months.

So with all of this, I hope that you're seeing that our development pipeline has gained momentum over the last year and with what is planned for this year. With COPD and bronchiectasis set for a biologics-driven decade and our programs stage for '26 to '28 catalysts, we're advancing differentiated mechanisms, disease-modifying ambition and value creation for the next few years.

And with that, it is my great pleasure to hand over to Fiona, who's just taken over as Chief Commercial Officer. Fiona, the floor is yours.

Thank you, Emmanuel, and I look forward to bringing KYGEVVI to patients. This is a unique drug with some survival benefit, which will really make a difference to these patients, but also to their families.

Good morning, good afternoon, good evening, everyone. As Emmanuel mentioned, we exchanged role 6 weeks ago, and so I'm delighted to share with you the performance of the team.

I'm just back from the U.S., and I can tell you the teams are fired up to deliver on the 2026. Next slide, please.

So let's start with BIMZELX, our IL-17 A/F. It's been reaching more patients.

It's fast, deep and durable action is really having a great impact on patients around the world. We've now been approved in more than 50 countries.

We've been helping more than 116,000 patients. And as Jean-Christophe mentioned, reached net sales of above EUR 2.2 billion.

If we look at our dynamic patient share in the IL-17, we're around 30% for psoriasis, 20% for our rheumatology indications and 45% for HS. So from a net sales split perspective, that gives you about 53% in PSO, 28% in HS and 19% in rheumatology.

Now if we move to the right-hand side of the slide and look at our uptake in the U.S. compared to analogs, you can see that we're really leading the pack and look forward to continuing on that track.

We are proud to say that we've increased our access coverage with 36 more million lives versus 2025 and so now have a coverage above 80% of the commercial lives. And as I sort of think about these progressive diseases that really creates lasting damage, it's really important that patients get access to our drug as early as possible.

If I may take sort of some metaphors, if you take PSA and you think about sort of sand in a gearbox, if you flush the sand away quickly, your car continues; if you delay at some point, your gearbox breaks. Likewise, for HS and you think about sinkholes, if you fix it quickly, it's okay; if you wait too long, the whole street comes down.

And for our HS patients, this is -- these are tunnels under the skin and lasting scars that you can never get back. So let's move to the next slide.

I know everyone is very interested in our performance on HS. So on the left-hand side, if we look at our performance in the U.S., we're now at a 32% market share.

I think back in July when Emmanuel presented, we were at 25%, and we look forward to continuing to drive our Formula 1 forwards. And we've shared some of the market shares across some of our countries around the world.

Now we often get the question on what do we think the HS market is going to look like going forward? As you know, we're learning about this new market every day, and it's growing significantly.

If we look at the number of patients back in October 2024 versus October 2025, we've seen a 24% increase in that space. And our estimates for between 2025 and '30 is that the market will continue to grow in the mid-teens CAGR and expect to reach around sort of $5 billion overall.

Now if we go to the next slide, let's talk about our rare portfolio. So first, our MG portfolio.

We are at UCB, the first and only company offering a dual therapy portfolio. We have RYSTIGGO, the FcRn and ZILBRYSQ, our self-admin C5.

Both of them are uniquely positioned. They're tailored to patient needs.

You know that this is a population of patients that's very heterogeneous, and it's also called the Snowflake patients. We are supporting these patients with an excellent patient support program.

They are now approved in 30-plus countries, have treated more than 3,700 patients and combined reach above EUR 0.5 billion in sales. And then I will finish with FINTEPLA.

With our strong heritage in epilepsy, FINTEPLA is it's now a foundational therapy in Dravet with about 20% market share in the U.S. and is gaining traction in LGS with 9% of the patients.

Worldwide, we've now treated more than 14,000 patients and delivered sales above 420 million. On that note, I'm going to hand over now to Sandrine, who will give you an overview of the overall portfolio as well as our disciplined execution and operational efficiency from a financial perspective.

Thank you very much. Sandrine, the floor is yours.

Thank you, Fiona, and good morning, good afternoon. I'm pleased to present our '25 results and our '26 guidance.

We delivered strong top line growth. We have expanded margins meaningfully, all while continuing to invest behind our launches and pipeline.

And that translated into a significant increase in profitability and clear operating leverage. And looking ahead, we remain focused on sustaining this momentum, driven by our 5 key growth drivers.

Let's start with 2025 net sales on the next page. The combined net sales of our 5 growth drivers more than doubled year-over-year, underscoring the strength of our portfolio.

This performance was primarily driven by BIMZELX, with net sales more than tripled to EUR 2.2 billion, reflecting strong volume growth across all indications with particularly robust momentum in HS. In the U.S., this was supported by a favorable payer mix with a high conversion to paid prescriptions and a meaningful proportion of unrebated scripts.

And that momentum continued into the second half where we also saw a positive gross to net true-up versus H1, driven by a more favorable channel mix than what we had initially anticipated. FINTEPLA continued its solid trajectory, delivering 26% year-on-year growth and reaching EUR 427 million in net sales, reflecting continued penetration across Dravet and Lennox-Gastaut indications.

Within the GMT franchise, RYSTIGGO and ZILBRYSQ together generated more than EUR 270 million of incremental net sales over the year. And this was achieved in an increasingly competitive environment and reflects our differentiated assets in this space.

EVENITY also delivered strong growth with net sales up 33% in Europe to EUR 137 million. It's important to note that this figure represents only the direct European net sales.

Our total economic exposure is significantly higher as reflected in the EUR 632 million net contribution from our partners in 2025, corresponding to 32% growth and which continues to be a meaningful contributor to profitability. Beyond the 5 growth drivers, CIMZIA delivered net sales of EUR 1.95 billion, down 4%, flat at constant exchange rate.

And despite being off patents, volumes grew by 4%, making CIMZIA the fastest-growing branded TNF across major markets. And this volume strength was more than offset by continued pricing pressure, particularly in the U.S.

driven by the new IRA Medicare Part D legislation and including the growing impact of 340B. BRIVIACT grew net sales by 11% to EUR 758 million with sustained growth across all regions.

The product was approved in Japan in June 2024 and has reached loss of exclusivity in the U.S. this week and will achieve loss of exclusivity in Europe in August this year.

And of course, this is reflected in our forward-looking assumptions. Briefly on ESG in '25.

We strengthened our environmental performance, improving our CDP climate change rating to A, and we were ranked An Industry Leader #2 in the Global Biotech by Sustainalytics. Our financial performance is underpinned by a consistent sustainability agenda, which we see as an important contributor to long-term value creation.

So let me now go to the financial performance and the profit drivers. And on the top of the page, let me start with revenue.

So total revenues reached EUR 7.7 billion, up 26%, 29% at constant exchange rates. This was driven by net sales of close to EUR 7.4 billion, up 32% or 35% at constant exchange rate, reflecting strong underlying demand across our growth portfolio.

Turning to profitability. Adjusted gross profit reached EUR 6.1 billion, up 27% with the gross margin improving to 79.2%, driven primarily by a more favorable product mix from our 5 growth drivers.

Operating expenses totaled EUR 3.7 billion, up a limited 5%, clearly demonstrating strong operating leverage. Marketing and selling expenses increased by 20% to EUR 2.5 billion, reflecting our continued investments behind the growth drivers, including deeper market expansion, new geographies and resource reallocation from mature to newer assets.

R&D expenses increased by 2% to EUR 1.8 billion, reflecting continued disciplined investment in the pipeline and early research, and as a result, R&D represented 24% of revenues. And finally, G&A expenses remained well controlled and decreased by 3%.

Other operating income was a positive EUR 829 million, up EUR 265 million versus '24. The majority of this, EUR 632 million, came from the net contribution from our EVENITY partners, which grew by 32%.

And in addition, we continued our portfolio simplification strategy with the sale of an asset for EUR 315 million, and this was partially offset by EUR 111 million of one-off costs related to the resolution of contractual commitments linked to a noncore asset. Altogether, this resulted in adjusted EBITDA of EUR 2.6 billion, up 79% or 87% at constant exchange rates, driven by strong top line growth, improved gross margin and significant operating leverage.

EBITDA margin increased by 10 percentage points to 34%. And if we correct for the asset sale and the one-offs, adjusted EBITDA came in at EUR 2.4 billion, representing a 31.4% margin, which is in line with the guidance that we updated back in December.

Moving to profit. Group profit reached EUR 1.6 billion, up from EUR 1.1 billion in '24.

Net financial expenses declined to EUR 126 million, driven by lower net debt. The effective tax rate was 14%, reflecting use of R&D incentives and deferred tax asset recognition despite a negative impact of Pillar 2, and it's in line with the underlying rate in '24 when adjusted for the China divestment.

Core EPS reached EUR 9.99, doubling year-on-year and closing another strong year for UCB. And finally, strong cash flow generation has allowed us to fully deleverage the balance sheet, giving us a strong and flexible platform to support future growth.

So moving to the next page. Let me now turn to our 2026 financial guidance.

First, we have evolved our approach to constant exchange rate guidance to improve comparability and transparency. Our guidance also reflects current rules and regulations.

It does not include any impact from potential MFN or tariff. We are, of course, closely monitoring the external environment.

So for revenues, we expect high single-digit to low double-digit growth at constant exchange rates. The underlying drivers remain the same 5 growth assets as in '25 with BIMZELX as the largest contributor, followed by RYSTIGGO, ZILBRYSQ, FINTEPLA and EVENITY.

On BIMZELX, we expect access expansion in the U.S. to come with a lower net price, which we anticipate will support strong volume growth.

The overall revenue growth rate will also reflect the loss of exclusivity for BRIVIACT in the U.S. and Europe, to a lesser extent, impact LOE in Japan as well as a modest negative perimeter effect related to last year asset disposal.

So overall, strong momentum from the growth portfolio, partially offset by expected headwinds from LOE and perimeter, and that's reflected in the revenue range. Moving to EBITDA.

we expect high single-digit to high-teens growth at constant exchange rate. And if we adjust the 2025 EBITDA for the product sales and the one-offs, so starting from a EUR 2.4 billion base in '25, we expect EBITDA growth at constant rate in the high-teens to high 20s, significantly outpacing revenue growth.

And there are 3 main drivers. First, continued improvement in adjusted gross margin driven by the evolving portfolio mix despite the impact of net price decrease.

Second, regarding OpEx, marketing and sales and R&D expenses will continue to increase. Their contribution to margin expansion will be lower than the exceptional operating leverage that we have achieved in '25, and this reflects higher volume-linked variable costs in marketing and sales and our continued deliberate investments in innovation.

We will maintain discipline and clear prioritization in the uncertain external environment that we operate in. And last, EVENITY's contribution is expected to grow faster than the top line, supporting further margin expansion.

While we will continue to actively manage and simplify the portfolio over the long term, we do not plan any established brand asset disposal this year. We expect the tax rate to increase to around 20%.

And we have provided you, at the bottom of this page, with the sensitivity of the guidance to foreign exchange impact on both revenues and EBITDA lines. So to conclude, overall, strong growth, accelerating profitability and a very solid financial position.

So with that, let me thank you, and I'll now hand over to Jean-Christophe.

Thank you, Sandrine. And thank you, Fiona; thank you, Emmanuel, for this overview of our performance 2025 and sharing with you our guidance for '26.

And as Sandrine has just said, I think you would agree with us that with the strong performance that we have delivered in 2025 -- next slide, please. With the strong performance of 2025, we are confident that we will be able to continue to deliver a solid growth again for 2026 and pave the way for a successful long-term growth for UCB.

And this is based mainly on 3 components. The first one is the continuous focus on innovation that have guided us for the last years and will continue.

This focus on innovation give us a possibility to build a portfolio of differentiated assets that creates very differentiated value for patients who need this asset to have the life that they want to live. Two.

Rigor and discipline in execution, the ability to be resilient, to be agile, to get the resource where we feel the highest return in order to deliver strong performance and efficiency. And three.

By creating an environment, a culture for everyone to be at their best and be purpose-led in such a way that we deliver the maximum value on the long term for all stakeholders, including, of course, the patient and shareholders. So with this in mind, we would like to move now to the Q&A, but allow me maybe a personal message before handing over to Antje for managing the Q&A.

Because today, it's quite a special day for us at UCB and maybe also for you as it will be the last full year results that Antje will have the chance to be with us, and we have the chance to be with Antje. As Antje has decided, after 27 years at UCB, to enjoy life outside of corporation, which I think it's fair for her to let her benefiting from that.

Antje, you know, has been the voice and the face of UCB for all of us and all of you. Her dedication, our energy, our engagement and commitment to serve our shareholders and all of you have really been an anchor of UCB successes in the past.

And for me, as CEO, since my very first day here, I always have had, with Antje, a very good and solid sparring partner who have been able to build and strengthen the reputation of the company and help me all along. So Antje, thank you very much.

Antje will pass the baton to Yvonne Naughton, who will take the position as of May 1 and have just joined us. So we'll have a few months of handing over.

And so, of course, we are very pleased to celebrate and welcome Yvonne, but at the same time, we are a little bit sad to let you go, Antje. So with that, I hand it over to you to reorchestrate the Q&A again for us.

Thank you.

Okay. Thank you so much.

That's indeed a very emotional moment. I'm thankful for everything.

I think we live together through so many different situations. I enjoyed it fully, even though it might sound strange, but that was good and bad.

And yes, it's time that I'm going private. I'm going to do all the things I haven't done yet from now into what's next, seeing the full potential.

And I will definitely miss you, this company and it's -- especially its people, my colleagues are fantastic and has been my life and my family. I'm here, as you say, until end of April, so we will have an opportunity to connect in the remaining weeks and also introduce Yvonne to you, who is already with us here.

And yes, for those who see us in London next week, that's for sure where you're going to meet us. Okay.

Thank you. So going back to business, we will now start the Q&A session.

[Operator Instructions]. The question session will be handled by our operator today, Kjell.

You can also e-mail your question to me under [email protected], and I will ask your question on your behalf. Kjell, operator, please explain how to ask a question.

Peter Verdult, BNP. I'm going to break with 20 years of traditional protocol because I, myself, never thank or congratulate management on public conference calls, but I will make an exception on this one and say, Antje, personally and on behalf of many people on the line, thank you for your service and professionalism.

It's been great fun, and good luck with your next chapter. Now back to business, 2 questions.

Firstly, just on R&D and then secondly, on capital allocation. Just on R&D, clinical trial risk in immunology and inflammation.

We've seen the pharma industry generate mixed data for OX40 in AD, MoonLake missed in HS, we've seen mixed data in COPD for IL-33. And some industry CEOs are claiming it's now harder to do clinical trials in I&I, citing difficulty recruiting biologically naive patients, moderate to severe patients and dealing with a higher placebo response rate.

So maybe anyone or Emmanuel, does UCB agree with this premise? And can you remind us what UCB does to ensure clinical trial success and how much of that clinical trial is done in-house versus CROs?

So sorry, a bit of a big picture question, but I think it's important when you think about galvo and the promise of that asset. And then more quickly, JC or Sandrine, your net cash found there's no interest in buybacks, and I assume your dividend policy is unlikely to change materially.

So is the message on be still about platforms and modalities and early stage pipeline efforts? Or are you now signaling that you're broadening your scope in terms of considering inorganic growth opportunities that might add revenues nearer term?

Yes, Peter, thank you very much for your question. And we see this, although there is variability across diseases.

So in certain cases, the endpoints, the duration to achieve the endpoints and the availability of patients that are moderate or severe is not as much of an issue. But clearly, the trend has been more noise.

And so the way we deal with this is, first of all, we're more prudent and careful around the design of the study. We're very careful around endpoint and time selection.

We're deploying more people, site managers to ensure that execution is tighter and that the education of the various sites around the world provides a level of homogeneity. We also tend to allow for size -- not to be too conservative on the sizing of the samples, just recognizing that there could be more noise.

And finally, in terms of CROs, we've gradually taken in more roles. But at the same time, we do acknowledge that in new areas, often CROs have a lot of experience that we can learn from.

And so we are very open in collaborating with those teams to make sure that we do not repeat mistakes or that we learn from prior experience. Thank you.

Thank you, Peter, for your second question. So you're right.

I mean, our strength in our balance sheet and the fact that we have now reduced and have no debt creates a lot of space in a sense for being able to consider investment in inorganic growth for the future. As you know, because we have our loss of exclusivity will not be before 2033 for the first one and until 2037, there is also -- we have also the time to think about it.

I used to say, and I think I've said that with you last year, that it was years of execution of launches, and we didn't want to create a potential risk to disrupt the organization by making integrations or acquisitions that will require local resources. Of course, after now several years of execution of the launches, we start to be in a phase where we can have some time to dedicate to potentially addition to our pipeline.

But the focus will be most likely on early clinical or clinical area -- assets and area where we have capabilities. And these questions of integration and complexity of integration will be, of course, also very much scrutinized.

So yes, we always have been looking. We are now a little bit more intentional on that with the objective to strengthen our capabilities, thinking about the long-term growth and be careful about not disrupting the execution of the launches.

At the risk of becoming emotional, many thanks to Antje for her key support in our coverage of UCB. Very excited for you, and we'll miss you.

So first, back to the Q&A. When we think about the revenue guidance range, the low end does suggest BIMZELX is in line with consensus and the high end of the range seemingly driven by BIMZELX outperformance.

So I would love to hear your views. And specifically, how we should think about the bio-naive HS patient segment as it relates to access and reimbursement?

Curious to get your thoughts on whether it will be different this year, as we think about upside? Second question is whether or not you all would be willing to provide additional details around donzakimig prioritization?

Does it relate to the emerging atopic dermatitis competitive landscape, your ability to think about donzakimig as a broader I&I platform? Just any additional details would be very much appreciated.

Stacy, thank you. I'm happy to start with the donzakimig question.

So indeed, as you mentioned, the atopic dermatitis field is quite competitive. And when we look at this from a portfolio point of view, we saw a big opportunity to double down on galvokimig based on the data we have in hand.

In terms of the biology of donzakimig, the combination of IL-13 and IL-22 inhibition probably is having a more narrow potential in terms of disease areas where this can make a big difference based on today's understanding of biology across autoimmune disorders. So indeed, those 2 things come to play.

Now eventually, we'll release the data, and it's an asset which we believe can have value. However, from a portfolio point of view, it wasn't prioritized at this point.

Right. And Stacy, your question on HS comparing the bio naive and the access and the reimbursement.

I think it's fair to remind that in 2025, we clearly benefited from a strong access from HS patients even in areas where there was no access coverage of formulary where there was a clear efforts from both physicians and patients to get access to the drug, and that, of course, translated into a full price. We do not expect this to repeat in '26 clearly because we have expanded access and formulary.

And so what we expect to see that there will be a coverage, which will be a mix of what we have, i.e., double-step edit, single-step edit and first line, and that expanded access will certainly trigger a stronger volume growth.

A quick follow-up then, Sandrine or Fiona. For HS, is the vast majority -- and this is obviously for the U.S., is the vast majority of coverage remaining at single-step edit access?

Yes. So 2 out of 3 of the PBMs is at single-step edits.

I would add also that, as you know, I mean, this is a market that's expanding along sort of 3 axes. One, for the moment, the diagnosis is extremely long.

It's above 7.3 years. And so we're working on accelerating that so that patients get treatments quicker to biologics in general.

Second, if you look at sort of the knowledge of the HCPs and then the number of HCPs willing to treat HS is expanding. And then there's a whole component around sort of patient activation.

And this is a disease that comes with a lot of stigma; a lot of shame, unfortunately; and helping those patients come out and ask for better treatment. Currently, if you look at sort of the split bio-naive versus not, we're at roughly sort of 40-60.

Both on BIMZELX, please. Just on the rheum indications.

Now, the BE BOLD readouts we've seen come forward six months-or-so, have you assumed any acceleration in the rheum indications in H2 in your guidance? Obviously, your MSLs will be able to talk to the data, even if your reps can't.

So just trying to get a feel for any potential upside, either included or not getting included in guidance? And secondly, just a bit more details on HS.

Something, Fiona, you didn't mention was stay time, and duration or persistence for patients on NHS. Obviously, for Humira and Cosentyx, we see very short stay time.

Just trying to get a feel for what you're seeing in the real world? I know you've got 3-year data out there, but in the real world, what are you seeing in terms of stay time on BIMZELX?

And in your $5 billion market size estimate, are you assuming increases in stay time?

Thank you for the question. So on the rheumatology indications, so we are expecting to accelerate in our rheumatology indication.

We have a strong belief that the IL-17A and F plays a difference for these indications, particularly in the joints. And as I -- sort of I was mentioning earlier, the earlier you treat sort of with a strong medication, the more you prevent lasting damage, but once it has taken place, it's difficult to reverse.

I would also say that you have a non-negligible portion of your psoriasis patients who do go on to develop psoriatic arthritis. And so we also expect sort of to have a spillover effect there.

On your second question around sort of HS. Yes, we look forward to taking advantage of the duration of some of the other therapies that we see on our sides.

We do see a longer persistence in for HS, and there is a slight difference between bio-naive and previous -- and switch. But all in all, we're -- we have a good persistence there.

And then your last question around sort of the $5 billion, I think it's -- I mean, as I mentioned, it's a combination of seeing sort of this disease being more and more recognized both by HCPs, but also, by your generalists who are gonna refer much quicker to dermatology. It's about sort of patients being more active and feeling less stigmatized and sort of pushed to the side, and an acceleration on your diagnosis times.

Thank you.

One question please, on BIMZELX as well. I think, Sandrine, you mentioned a gross-to-net adjustment in the second half.

I wondered if you could quantify that and maybe just give us a little bit more detail in the gross-to-net development from the second half of 2025 and into the first half of 2026, just to give us some color there as you increase the coverage? And then second question, just on bepranemab.

Very good news getting a fast-track designation, but this is still a pretty high-risk area relative to others in development, so just wondering about the thoughts around partnership here to share the risk of further development around that product.

Yes, so on the impact, indeed, so I said that in the second half of '25, we had a crew up of gross-to-net from H1 to H2, and it represents around 5% of our total BIMZELX, just to give you a sense. And then, you know, on the evolution from '25 to '26, we still benefited in the second half of '25 from this large proportion of unrebated scripts, and logically, as we are expanding the access, that will come with full price moving to net price, which are very in line with the ranking of the access coverage, so depending on the indications and depending on the payers, as you know, we have a mix of double-step edit, single-step edit, and first line, and so that's how it should evolve from '25 to '26.

And Peter, thank you for your question on bepranemab. So indeed, we share your view in terms of the risk that comes with Alzheimer's disease programs.

So at this point, we're open to various ways to mitigate that risk. So far, we've been really focused on unlocking and addressing critical path questions of CMC and regulatory nature, and now that this has progressed well, we are looking at this de-risking, which is both an asset and a portfolio consideration.

First of all, thank you for all the interactions and all your help, Antje, and wish you all the best. To my question, so just wondering in terms of HS, so just wondering -- thank you very much for the color in terms of the 40-60 split between bio-naive and refractory patients.

But just wondering going forward, where do you expect as a main source of growth? So do you still have big bolus of patients that hasn't had either bime or Cosentyx, or is it more from switch from Cosentyx or even just naive patients, you're kind of -- all patients who are not seeking active treatment at the moment?

Kind of linking to that so just wondering, when you mentioned the mid-teens CAGR for the HS market, linking to this question as well, so just wondering, do you expect this to be relatively linear or more back-end loaded, as you probably have to educate the physicians and everything? So that's kind of a, sorry, long first question.

Second one, on galvokimig. So on ct.gov, it still says the primary endpoint is 16 weeks, but now you're saying you're doing blinded dosing to 52 weeks with top-line data in 2028.

So just wondering would you be able to -- is ct.gov simply not updated or would you be able to potentially have a look in the middle and start Phase III before 2028?

Thank you for the question on BIMZELX. I would say, I mean, it's a combination, and it's gonna happen, of course, over time.

So first, it's about gaining market share in the IL-17 and moving that whole class sort of earlier moving from moderate to severe to moderate and as closely as possible in the pathway. Two is accelerating that diagnostic, so moving it from sort of 7.3 down to significantly lower.

Three, expanding the number of physicians who are ready to treat HS, and then in parallel, of course, activating patients. So that's going to happen over the next sort of five years in a staggered way.

Emmanuel, I'll hand over for galvokimig.

Yes. Thank you.

And thanks for your question indeed. So the study is blinded for the entire 52 weeks, we would want to ensure that not to jeopardize the study integrity.

It's a study where it's both a learned study and a dose-ranging study, right? We certainly want to make sure we get the full value of this investment.

It's designed to inform us to take the best possible step in an area which is quite competitive, but also quite complex from a heterogeneity point of view. So with this, we're not going to move earlier, as per your question.

I've got a couple. Sorry, another one just on BIMZELX then and price.

I'd just be interested to understand when you expect to reach a steady state on net price in the U.S.? Is 2026 sort of a step-change in the trajectory?

And then within 2026 specifically, do you expect price to compress through the course of the year? I'm just wondering if any of that positive effect that was -- that you mentioned in the second half of '25 holds true into the beginning of 2026.

And then second question was actually just on pipeline. So I noticed that you had the ocular myasthenia gravis phase III.

As it happens, one of your competitors shared their phase III data this morning. They showed a 2-point improvement on the primary endpoint.

Do you expect to show a similar level of efficacy, or is there room for improvement, and do you expect to use the same endpoint?

So maybe first to answer your question on BIMZELX and the net price. As Sandrine was mentioning, I mean, versus last year, we'll have much less unrebated scripts or full price, as we've sort of negotiated more and more the access across our different indications.

There is still more potentially to come, where we evaluate, of course, every decision sort of meticulously from a finance perspective on increasing access versus -- and increasing volume versus rebates. What we can tell you for the moment is, we've just increased by EUR 36 million, and we'll continue to evaluate that as opportunities and negotiations progress.

Thank you for your question on ocular MG. So I'll get back to you -- or our team will get back to you as to the endpoint.

I'm aware of the news this morning, but I haven't gone into the details yet. What I can say is that from a generalized myasthenia gravis experience point of view, two things have become clear over the last years.

Firstly, that anti-FcRNs really are used early, and therefore, going into ocular MG, where most of the patients start with eye symptoms, makes a lot of sense for the medium and long term. And second, we know from clinical practice that not only does RYSTIGGO provides a pretty robust efficacy that stays over time, but we also see that the cycle times are not too variable, relative.

We believe that there's something with this medicine that will translate to ocular MG, and again, we'll get back to you as to what we can share in terms of the details of the study.

I'd just like to also pass my thanks to Antje for all her help over the time covering the company. I think two questions on BIMZELX from me as well to maintain the theme.

Firstly, just within the psoriasis indication, one of the things we've seen in some of our prescription data is that it appears BIMZELX has started to lose share versus other novel biologic peers over 4Q 2025, particularly against some of the IL-23s, so I was wondering if you could just provide a bit more commentary on if whether or not that's a trend you're seeing and what really explains it, and what your -- specifically, therefore, what your strategy is for trying to regain that share going forward to support your broad expansion of the BIMZELX sales? And then secondly, just in terms of competition, I mean, one of the other things we've seen very recently is that MoonLake has announced that they have been -- they've received a positive confirmation from the regulator that they can file using one of their Phase III and their Phase II data, with the potential that any of their label -- any label would therefore include numerically superior efficacy results, so I'm just wondering how you're feeling about the competitive dynamics from sonelokimab across HS and psoriatic arthritis, given their Phase II positive data?

Yes, let me answer your question. So maybe there -- I mean, on the first one, so you'll see that we, over the last two weeks, we've had, 2 consecutive weeks with over 7.2.

I think it's important to realize that January and a bit February has been sort of a -- there's been a lot of noise in the system for all products because of snow days, four days a week, and the general noise that you have in January as the new year kicks off. I think we -- you'll see that we've continued to grow from an IL-17 -- within the IL-17 class.

And we look forward to having BE BOLD that reboots and gives us even more energy to continue to compete in the psoriasis area. If I take MoonLake, I would say, well, first, we are the only one on the market with significant data over all our head-to-heads and over the duration, if you include not only launch, but also all the clinical data that we've accumulated.

They have shown some efficacy. It's been mixed results, and that information and that data will need to be included should they be able to get an approval.

So I think you can't go in thinking that you can cherry-pick data. The FDA will expect to have the full package.

And let's see how they do that and what happens there. But yes, want to reinforce that by the time they come on the market, we will have been there, we will have proven how effective our drug is, and our data is consistent not only within our indications but across each of the indications.

Just on BIMZELX and coming back to HS, apologies. Could you comment on the market share evolution versus Cosentyx?

Has this now stabilized? And how should we think about the broader HS market in terms of growth expectations this year?

And are you to be confident that you can continue to meaningfully outgrow the market this year based on current scripts? And then the second one is on the change at the FDA with a single pivotal trial sufficing for approval.

How might this influence dapirolizumab for SLE? Is there a chance for an earlier approval based on the current one positive trial?

So let me start with BIMZELX, and Emmanuel, let me know if you take dapi or not? So first on BIMZELX, HS, I think you've seen the graph that I showed earlier, where we see sort of good progression with currently around 32% market share within the IL-17.

Previously, back in July, Emmanuel shared data with you that was around the 25%. We have the better drug.

The F component in the IL-17 really does make a huge difference to these patients, so it's our mission, both for the teams out in the field as well as us in the head office, to make sure that these patients are treated adequately with the best treatment option. I was speaking a few weeks ago with a patient who was in a clinical trial, who was on the placebo part, and he shared with me sort of the scars just from that simple 6 months period, and those are scars that never go away.

So I think it's not only important, but it's our duty to make sure that we continue to progress this year in the IL-17 and lead the pack there. And I think from a sort of market growth perspective, as we mentioned, it's gonna continue to grow in the mid-teens.

Between the effort of us and other players in the field, we are seeing that market continue to progress. Emmanuel, do you wanna cover dapi?

Yes, for sure. Thank you for your question.

Indeed, we did approach the FDA with that question. However, it won't apply to dapimab yet.

I think there's some intricacies around the secondary endpoints in the first phase III study as well as the phase II study, which makes that package not quite reach the level that would be acceptable today for going with a single Phase III study. Obviously, if we see more opportunities to cut the time, we'll seize them.

For now, we're busy recruiting rapidly in the second Phase III study.

Charlie here with Bank of America. I have 2, please.

First one, I'll keep it simple. BIMZELX '26 consensus is around EUR 3.1 billion, which I think if you annualize your second half sales, gets you to within 10% of that number, so How comfortable are you with consensus?

And secondly, I think by my maths, your second half U.S.-based sales are around EUR 400 million. Given in second half, you had 2/3 of the big PBMs covered, which is likely the majority of volumes.

Can you just help quantify of that EUR 400 million number, the absolute pricing benefit, sort of uplift you could have seen in second half that could reverse, as those patients become rebated?

Yes, I can take this. I don't think we comment on consensus per asset.

We typically don't do that. But overall, I think we provided the guidance.

We -- '26 for BIMZELX is going to be a combination of strong volume growth and evolution of the net price. I wanted to call out the fact that in the second half of 2025, we had a bit of this true-up that you need to factor in when you look at how H1 and H2 dynamic comes in '26.

And at this point, this is how we want to support and help you on the projection.

Of course, thank you to Antje. I just have a couple of questions.

Could you comment on the U.S. formulary position in immunology in terms of any trend you are seeing towards basically parity access for all drugs and this leading to a bit of a shift to competition more in the doctor's office?

Just wondered -- we heard it from a competitor. Just wondered if you're also sensing that trend.

And then interested in your comment that CIMZIA are still seeing volume growth, and I just wondered is that across all markets? And are you, on the whole, expecting that TNF volumes will be stable to slightly growing in the future?

Just thinking of that as a sort of a pool of patients switching to newer therapies, but overall, should we anticipate TNF stable to growing over the coming years?

Thank you for your question on the U.S. formularies.

No, so I wouldn't say that we've currently sort of seen everyone going to parity. I mean we still have sort of the double-step, single-step or first line or excluded in sort of the packages that -- yes, and how the formularies are set up for the moment in the U.S.

On your question on CIMZIA, so we continue to see increase in growth for CIMZIA. I would say it's standing out from the TNF lot in general.

So there's very different dynamics for the rest of the TNFs. And I do think it's really because of the uniqueness of CIMZIA and how it's PEgylated formulation and the impact it has on particular patient populations.

Thank you.

Congrats on a strong year. Also want to add my congrats to Antje for your new journey.

I have two questions. First is regarding BIMZELX.

For psoriasis and for the rheumatology indication, how should we think about the penetration or market share in the total biologic market beyond just IL-17? And how should we think about the gross-to-net in the longer term?

Second question is for FINTEPLA. I'm just curious about your current thoughts on the gene therapy competitor programs, including the ASO and AAV gene therapy for Duchenne syndrome.

Apparently, at the same time, you know, there are a couple [indiscernible] drug, in late-stage trials. How would these new products potentially, I mean, change the market dynamics in the coming years?

So maybe let me start with the gross-to-net. I mean, I think Sandrine has sort of mentioned it as well.

So one -- I mean, we will see a difference between last year where we had quite a few scripts, medical exception at full price. Now you will see a net price or gross-to-net more in line with where our access coverage is, whether it's first-line, single-step or double-step edit as well taking into account, of course, that the dosages across the different indications and loading doses are different.

Your question around FINTEPLA -- sorry, I'm just going back to my notes linked to the question that you asked. So your question around FINTEPLA and potentially future competition.

Well, first, in general, usually competition increases the market and is a good thing for both patients and for us. I would say what we are seeing with FINTEPLA is really a strong impact.

From an efficacy perspective, we've just, as Emmanuel mentioned, shared the outcome of the Phase III data for CDD, which reinforces not only the impact that we have on seizure, but also on the non-seizure outcomes and we hope to sort of further increase our data package and improving the efficacy and the benefits of that drug with our Rett syndrome indications. So I think that by the time that they come on the market, the wealth of data and the proven real-world evidence will support FINTEPLA as a strong option.

Thank you.

So that was the final question for today. Thank you so much.

Thanks to Jean-Christophe, Fiona, Sandrine and Emmanuel, of course, of my screen here. Thanks to the audience, you have been very patient with us.

We went definitely well above the hour. And yes, thank you all for everything.

I enjoyed every moment, and I wish you all the best. For every question that is open for any future interactions, you know where to find us.

We are here, and we are going there to continue to serve you as good as we can. Thank you.