Hello, and welcome to UCB's half-year 2026 presentation conference call and webcast for investors and analysts. I'm Yvonne Naughton, Head of Investor Relations. Before I hand over to Jean-Christophe and members of our executive team, I would like to cover some housekeeping items. Today's presentation is available for download on the Investor Relations section of our website. The presentation and Q&A session are subject to the disclaimer and safe harbor statement contained on slide two of the presentation.
Moving to slide three, our speakers today are Jean-Christophe Tellier, Chief Executive Officer, Emmanuel Caeymaex, Executive Vice President and Head of Patient Evidence, Fiona du Monceau, Executive Vice President and Chief Commercial Officer, and Sandrine Dufour, Executive Vice President and Chief Financial Officer. Following our prepared remarks, we will open the line for questions. As usual, we will try to address as many questions as we can. Please limit your questions to allow others a fair chance to participate in the Q&A. With that, I'll hand over to you, Jean-Christophe.
Thank you, Yvonne. Good morning, good afternoon, and good evening, everyone. It's a pleasure to welcome you to our half-year result presentation, and thank you for joining. Next slide, please. As you have seen in our press release this morning, we are very pleased with the result that we have been able to deliver during the first half of the year, continuing to build on the strength of our growth that we had delivered in 2025. If I want you to keep just one or two numbers illustrating this growth, I will look at the top left-hand side of this slide and show that basically our big growth drivers, our five products that currently are driving our growth, are already delivering more than 50% of our revenue, which is quite exceptional.
That has been able to show more than 28% of growth at constant rate for our net sales. So definitely a strong growth at the beginning of the year, built upon the portfolio of the growth driver that we have, which allow us to move on the right-hand side of the slide, where you can see, and Sandrine will comment on that we have upgraded our guidance for 2026 versus what we had shared with you earlier.
On top of that, we have also published this morning a new peak sales of BIMZELX, above EUR 7 billion of revenue. That put us in a quite unique position, and the reason why we are in this quite unique position is exactly summarized here. A group of products which are growing very significantly today already, and we will have enjoyed a period of growth without a loss of exclusivity. This is what you see on the bottom of the slide. The first product that will lose exclusivity in the near future is FINTEPLA in 2033, and the last one will be BIMZELX in 2037. We still have ahead of us 10 years of growth with BIMZELX.
Moving to the next slide. You can see that the growth that we see today is based, of course, of what we have been able to deliver. The first half, we had also very good news to expand the growth beyond what we see today. I would like to start with BE BOLD and with BIMZELX. For the first time ever, a product has been able to demonstrate superiority versus standard of care, in our case, versus IL-23, SKYRIZI, in psoriatic arthritis, based on a very severe criteria, or difficult criteria to reach, if I may say, ACR 50.
We have been able to confirm with this study what we have been able to deliver already in psoriatic. This is the fourth superiority clinical trial achieved with BIMZELX. Each of these results confirm the unique profile of BIMZELX. Fast onset of action. The case of BE BOLD, we see the difference already in the fourth week. The depth of the efficacy, ACR 50 in the case of BE BOLD. The duration of activity, we see the curve continue to differentiate up to 24 weeks and will be beyond. The safety profile, which is comparable for the two products. There is no difference in terms of drop of treatment or treatment discontinuation between SKYRIZI and BIMZELX. This is quite unique, and this is also what give us a very strong confidence moving forward with the potential growth of BIMZELX.
BE BOLD have been published in June 2026, but we have also a way to continue to maximize the value of our growth with the life cycle extension. In the case of BIMZELX, for example, it's the extension to child and adolescents in HS and other rheumatoid disease. In FINTEPLA, we have already filed CDD, CDKL5 disease disorder, deficit disorder, and we are starting also a study in the Rett syndrome. If we think about beyond this phase of the current growth that we have with our current portfolio, the first half has been also very rich for UCB in terms of preparing the future beyond 2035, 2037. In the case of our own pipeline, we have decided to move with bepranemab into a confirmatory phase II study.
Despite the fact that our primary endpoint was not positive on the POC, we thought that we have a very strong signal in a subpopulation of low tau activity, and we have decided to do a confirmatory study phase II on this population that will start soon. Galvokimig, our bispecific IL-13, IL-17A and F, after having done and started a clinical trial in atopic dermatitis, where the recruitment is doing very well and faster than expected, we have decided to move on into respiratory and evaluating the product in two diseases in phase II, COPD and non-cystic fibrosis bronchiectasis. On top of our internal pipeline, you have seen also that during the first half, we have moved into inorganic growth with four acquisition. Each of these acquisition will strengthen UCB for the long-term sustainable growth and success.
IMIDomics is a Barcelona-based biotech company where we give us access to more than 17,000 of DNA material that we can evaluate, target potentially, and switch patients' population. Neurona is a biotech where first of all, for us first, we will get in cell therapy in a very severe epileptic disease, a major temporal epilepsy. With cell therapy, we are an ability to reduce the level of the numbers of seizure and to significantly increase patients, so in our core of neurological focus. In immunology, the in-licensing of an asset for Antengene and the acquisitions of Candid Therapeutics give us a very solid now additions to our own pipeline in T-cell engagers, and Emmanuel will comment on that.
As a summary, a very strong first half of the year based on solid execution that give us huge leverage moving forward. Visibility and a unique position because a lot of exclusivity will come late. Strengthening the data set that we have with BIMZELX in particular. Continuing and developing our asset and pipeline, acquiring new companies, and preparing the long-term future. This is in a nutshell, the summary of a very rich first half of the year. With that, I hand over to Emmanuel. Thank you.
Thank you very much, Jean-Christophe, greetings everyone. Indeed, it's going to be my pleasure to give you some more details on our two acquisitions, namely Candid Therapeutics and Neurona. Clearly, very good strategic fits, but also potentially paradigm-shifting therapies. Before I do that, let me just set the scene. On the next slide, you'll see that we're really focused on shaping the next phase of growth with these acquisitions, and it started from first of all, our purpose and our strategy to expanding the horizons of what's possible for patients. Be ambitious in terms of the clinical endpoints that we're going after. Moving from deeper clinical response, where we are today, to an ambition of long-lasting drug-free remission, and ultimately, potentially even cure. If you take BIMZELX, for example, as a first modality, it's a dual cytokine inhibitor.
In psoriasis, for example, BIMZELX has been able, as the first drug ever, to bring seven out of 10 psoriasis patients to a state of totally clear skin for a full year. That wasn't possible before BIMZELX. Likewise, BIMZELX in other indications may not be able to achieve such deep level of disease control and potentially remission. We've been continuing to look for solutions for diseases that are more heterogeneous than psoriasis. Galvokimig is a good example where from the phase II study, we had about 90%, sorry, EASI 90 achieved in about half of the patients. That's probably only possible because we inhibit multiple pathways. Really leveraging the power of combinatorial biology in a well-informed manner represents another strategy to achieve deeper clinical response.
Now, really for a step change, one needs to look at different technologies, we've been observing the field of CAR T for quite a few years, and have decided to invest in T-cell engagers. First with the licensing of ATG-201, and second with the acquisition of Candid Therapeutics. Because those medicines really promise transformative potential, meaning drug-free remission for potentially quite a long period of time, in a manner that is scalable. Scalable, not just from an accessibility and a cost point of view, but also scalable from a safety and tolerability point of view. With cizutamig, we have a BCMA T-cell engager, really going after autoantibodies about the autoantibody production. Very complementary to the earlier license of ATG-201, which is targeted at CD19, which is a broader B-cell strategy.
We are aiming to redefine the outcomes, and really this can be our next step in immunology. It's a large market opportunity. I think we're still defining what B-cell diseases truly are, and that seems to be a pool that is expanding as we discover empirically what the impact is of those molecules and others. This focus on B-cell driven diseases is one that we're now pursuing with Cizutamig. We are focused on depleting pathogenic plasma cells, and it's really focused on deep depletion, with potentially a best-in-class profile. I'm referring here to the fact that the incidence of cytokine release syndromes and of neurotoxicity, ICANS, has been low and has been favorable. That's really been factored in our choice for Candid Therapeutics.
This has been presented recently at the EULAR Rheumatology Congress, where one has an overview of about 50 patients treated both in Europe and in Asia in phase I type studies, signal-seeking studies. You see there's a variety of conditions here that are depicted. The efficacy has been remarkable. Not much of this is published, but more to come next year. What's really been of interest here is the favorable safety. So there's been no CRS higher than Grade 2, and in fact, only one Grade 2 CRS. No death reported in those autoimmune studies, despite, of course, dealing with very sick patients, and no incidents of ICANS at all. That, I think, is the early clinical signal, let's say, that this balance between potentially revolutionary efficacy and the favorable safety and tolerability profile is achievable.
In 2026, we are planning to get cizutamig into phase II exploratory studies, one in myasthenia gravis, and another one in interstitial lung disease that's associated with chronic rheumatology conditions. Very exciting times ahead for our autoimmune franchise. Likewise, on the next slide, you will see that we're equally excited with our acquisition of Neurona Therapeutics. Obviously, it's going to build on 30 years of UCB presence and leadership in epilepsy and take a resolute step forward to disease modification. We've decided to focus on a technology and a potential therapy that can really address seizures and potentially the underlying disease in patients that have failed on many of those oral anti-seizure medications. Rezanecel, as it is called, is an allogeneic off-the-shelf GABA interneuron therapy. It is delivered in a one-time, minimally invasive intracranial procedure.
We've seen in the data published or available so far that there's been no serious adverse events related to the cells or the procedure. It's remarkable in terms of its results, of course, as we were looking into the data, we were very impressed a few years ago reading about and hearing about this first patient who had about 30 seizures a month. After that single administration of these interneuron cells, the seizure count for disabling seizures went down to less than a handful. Really life-changing. In fact, for this particular patient, the difference between staying at home feeling hostage to unpredictable seizures occurring, to actually being at work.
If one looks at the broader data set that's available now, you see that on the bottom of the right-hand panel, we see, for example, that in unilateral mesial temporal lobe epilepsy, we have close to 90% of seizure reduction as a median in 7-12 months into the therapy. Bilateral patients who are not even candidates for epilepsy resective surgery, so destructive surgery, the first patient there achieved 100% seizure freedom for a year. This really tells us that this could be life-changing for many patients and is definitely something that, from a patient point of view, will be potentially very attractive as an alternative to epilepsy surgery, which of course comes with the threat of cognitive and behavioral adverse events, let alone the waiting lists and the costs.
The regulators have recognized the promise of this investigational therapy with the RMAT and PRIME designations. I'm pleased to announce that we will start phase III in the first half of next year. We regard this as a great opportunity for patients and also a way for UCB to continue to build on its leadership in epilepsy. With that, it's my pleasure to hand over to Fiona now, who will take us to our growth drivers. Fiona?
Thank you, Emmanuel, and thank you for the update on the pipeline. I'll now focus on our five growth drivers with the title, Winning Through Execution. If we go to the next slide, I'm really happy to share with you our revised peak sales potential of at least EUR 7 billion, like J-C mentioned earlier today, for BIMZELX. This is very much based on the strong execution that we see again this half year. The teams out in the field, the very diligent mixed channel between field and other DTC, as well as using AI where appropriate, and expanding strategically our access. Second, our evidence base. We now have four head-to-head superiority studies, with most recently, as J-C mentioned, the BE BOLD, where we shared our data at EULAR back in June. It's a head-to-head study against SKYRIZI.
We are the only company who has shown superiority against a biologic in psoriatic arthritis. On top of that, we measured it on ACR 50, really raising the bar for our patients. We are increasing our real-world evidence. We now have five-year data for PSO, four-year data for psoriatic arthritis, and three-year data for HS. The third lever is around expanding our indications. Our PPP trial is recruiting well, and our pediatric studies as well. As J-C mentioned, you will have the top-line results for adolescent HS trial in H1 2027. Now let's focus on the execution with the next slide. Bimzelx is continuing its great momentum.
We have now approved in more than 50 countries. We have helped more than 135,000 patients, and our net sales for this half year are EUR 1.5 billion, twice from last year. On the IL-17 dynamic shares, we continue to progress with now 35% in PSO, 30% in our rheumatology indications, and more than 45% in HS. Our net sales splits across the indications of 45% for PSO, 33% for HS, and 22% for rheumatology. I'd like you to pause and look at the top right corner with Bimzelx performance versus other analogues.
As you can see, we continue to have great momentum versus the others, and we're still very early on in our journey, in our growth journey. On the access side, back in February, we shared with you that we now have 80% of commercial lives that have access to Bimzelx across all indication, as well as the vast majority of Medicare and Medicaid patients. We've also progressed the mix. On 1st of June, across all indications, we have now first-line with one of the PBMs.
We really think about this as sort of what stage, what coverage to have with the access based on three dimensions. Sort of one, the experience we want to have with our physicians and our patients, moving at the right time and at the right speed so that the access matches the prescribing line of our physicians. If we move to HS on the next slide. In the U.S., we continue to see great momentum after a temporary spike of biosimilars early January. We see the nice trend going back up with a 34% dynamic market share.
In the rest of the world where we launched earlier than in the U.S., we now have dynamic shares in Italy of above 60%, in Spain of above 55%, and in Japan above 70%. Our ambition is really to lead in HS. We are the best product for our patients. It's still a market that has huge potential to grow. It needs to grow, one, because a lot of our patients are lost in the system of finding it difficult to find the right physicians to treat them. They are often sort of pushed away.
So it's really important that, one, these patients get diagnosed earlier, get access to the right physicians as quickly as possible, and then are treated with biologics, where there's huge room to progress. This all leads us to believe that the global market potential for HS, by 2030, should be around EUR 5 billion. Now let's focus on the other four growth drivers. First, Evenity. Evenity is our bone builder, which we have in partnership with Amgen. It might now has leadership in quite a few markets. It's treated more than 1.5 million patients since launch.
The net contribution with our partner is EUR 379 million. The net sales for UCB are above EUR 88 million, and shows a growth of 34% versus last year. In the middle, you see our gMG portfolio. As a reminder, UCB is the first and only company with a dual therapy portfolio. This enables us to tailor treatments to the right patients. The portfolio has now treated more than 4,100 patients, with net sales of EUR 330 million, and a growth of 38% year-on-year.
To finish, FINTEPLA, with our long history in epilepsy, again, here is treating more and more patients with strong differentiated data. 16,000 patients have been treated, net sales of EUR 239 million, and a growth of 18%. Really excited about the performance of our growth drivers and about the revised peak sales potential of at least EUR 7 billion for BIMZELX. Now I'd like to hand over to Sandrine, who will cover the finance. Thank you very much.
Thank you, Fiona. Good morning, good afternoon, everyone. Let me first comment on the first half performance, and then we'll see how it translates for the year with an upgraded guidance. If we move to the next slide, we continued our long-term sustainability journey for the first half of 2026. We delivered strong top-line growth with expanded margins meaningfully, as we actively invest behind our next phase of growth. The total net sales grew by 23% to EUR 4.1 billion, driven by the strong underlying demand of our growth portfolio, supported by a solid performance of CIMZIA. The combined net sales of our five growth drivers make up more than 50% of our total net sales, and Fiona just commented on the underlying drivers of growth.
Beyond the five growth drivers, CIMZIA delivered a solid performance of EUR 954 million, down 1%, but still growing by 4% at constant rate. Performance was driven by volume growth as CIMZIA continues to be the fastest growing branded anti-TNF across Europe, Japan, and international markets. This reflected the differentiated profile of CIMZIA as the only Fc-free TNF inhibitor and our ability to maintain competitiveness through the life cycle of our drugs. BRIVIACT contributed net sales of EUR 327 million, down 13%, and reflecting entry of generics in the U.S. in February. We expect to see in the U.S. an 80% decline in sales over the 12 months from the loss of exclusivity and 50% decline in Europe, when losses of exclusivity is expected in August this year.
Regarding sustainability, we continue to maintain our leadership position across ESG ratings with TIME and Statista recently recognizing UCB as one of the world's most sustainable companies, this is reinforcing our commitment to long-term value creation. Moving to the next slide and the financial performance and the profit drivers. On the top of the page, I'll start with the revenue, we've highlighted the very good top-line momentum in the first half with total revenue increasing by 22%, 27% at constant rate to EUR 4.3 billion. This was driven by the net sales of EUR 4.1 billion up 23%. Revenue in the first half also benefited from a number of phasing dynamics, which should be accounted for when considering the second half trajectory.
That includes the BRIVIACT loss of exclusivity, which is second half weighted, given the fact U.S. went off patent late February, we expect the loss of exclusivity in Europe in August. The first half of 2026 full portfolio and predominantly BIMZELX and CIMZIA benefited from around EUR 100 million prior year gross to net adjustments. As every year, there's significant lags for some channels, this is reflected in this amount. Finally, we secured meaningful new access for BIMZELX, as Fiona mentioned, including one significant agreement effective as of 1st of June in first line in all indications. This is expected to create additional net price pressure in the second half, while the related volume benefits will take more time to build and contribute positively to growth. If I turn to profitability.
Adjusted gross profit reached EUR 3.5 billion, up 27%, 33% at constant exchange rate, with the gross margin improving to 82%. This was driven primarily by a more favorable product mix also benefiting from the pricing effect, the prior gross to net adjustment. Even if less pronounced than the first half, we still expect to see a net improvement versus 2025 for the full year, thanks to favorable product mix more than compensating the pricing effects. Operating expenses were EUR 1.9 billion, up a limited 2%, clearly demonstrating strong operating leverage. Marketing and selling expenses increased by 6% to EUR 1.2 billion, reflecting our continued investment behind the growth drivers including deeper market expansion. R&D expenses increased by 6% to EUR 903 million, reflecting continued disciplined investments and pipeline prioritization.
We expect the full year R&D ratio to be closer to 25%, first, as a result of some phasing as every year, second, considering R&D expenses following the acquisitions of Neurona and Candid. Finally, G&A expenses increased 20%, reflecting digital transformation programs across the value chain as well as some phasing effects, we do not expect this level of increase to be representative of the full year trajectory. The other operating income was a EUR +394 million, driven by EUR 379 million net contribution from our affinity partners, it's a growth of 34%. This resulted in adjusted EBITDA of EUR 1.7 billion, up 68% or 79% at constant rates, driven by strong top-line growth, the improved gross margin, significant operating leverage.
The EBITDA margin reached 40.7% in the first half, also reflecting the phasing dynamics in net sales and the R&D investment timing that I have just outlined and should therefore be considered in the context of our full-year guidance. Moving to profits. Group profits reached EUR 1.1 billion, up from EUR 475 last year. Net financial expenses declined to EUR 69 million, of which EUR 25 million of net interest expenses that is expected to increase following the recent debt-financed acquisition, while the hedging costs linked to the acquisitions are included in other financial expenses will not reoccur. We ended the period with a total net financial debt of EUR 2.8 billion, lower than one-time EBITDA. Effective tax rate is 15%, as expected for the full year, reflecting strong business performance and partially offset by the continued use of R&D incentives and additional recognition of deferred tax assets on losses.
Core EPS reached EUR 6.84, almost doubling year-on-year. In summary, this first half was very strong, and it gives us the confidence to upgrade our guidance for the year. Moving to the next slide. We remain focused on sustaining our growth momentum at both top and bottom line, and we're increasing our full-year guidance. For revenues, we expect low teens to mid-teens growth at constant exchange rate, the underlying drivers remain the same five growth assets with BIMZELX as the largest contributor. Year-on-year H2 evolution versus H1 growth will reflect the various phasing dynamics that I have explained.
Moving to EBITDA, we expect mid teens to low 20s growth at constant exchange rate, and this is the direct result of revenue growth, and it's also driven by continued investment behind our five growth drivers, focused R&D execution, and integration of our recent acquisitions, Neurona and Candid. EVENITY's contribution is expected to grow faster than the old top line, supporting further margin expansion, and we expect the core tax rate to be around 15%. 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.
As a reminder, our guidance reflects the current rules and regulation. It does not include any impact from potential MFN or tariffs. To conclude, a very strong first half with continued top-line momentum, significant operating leverage, and a solid financial position, giving us the confidence to upgrade our full-year guidance while continuing to invest behind our next phase of growth. With that, I thank you and I hand back to Jean-Christophe.
Thank you, Sandrine. Thank you, Fiona, and thank you, Emmanuel. I think we have been able to cover the different part of this first half, moving from strong executions to strengthening the portfolio and the confidence in the future, as well as the ability to deliver on the various line on the P&L, a very strong performance. Next slide, please. What I would like to leave you with is a very simple message. The strategy of UCB always have been to concentrate on innovations and making sure that through innovation, we are able to deliver a very unique patient value.
This is what we are delivering year after year and semester after semester, like we are doing this time. Two, with the space and the strategic flexibility that we are gaining through this execution, we are delivering not only strong data, but we are also investing in order to make sure that the pipeline continues to develop and that we are also able, through inorganic growth, to strengthen our offering.
That in the end, we are not able to be in the positions to deliver growth today, but to continue to deliver growth tomorrow and to be in the best possible solution for the long-term success of the company. With that, we hope, and that you have been able to be convinced by what we are sharing with you today, because our job is to, of course, deliver sustainable value for our shareholders, for the patient, and for society. With that, I would like to thank you for your attention and moving to the Q&A session. Thank you.
Thank you. Ladies and gentlemen, we will now begin our Q&A session. If you have a question, we ask that you please use the raise hand function at the bottom of your Zoom screen. Once your name has been announced, you can ask a question. If you want to withdraw your question, please lower your hand using the raise hand function in the Zoom app. Thank you. Our first question comes from Peter Verdult from BNP. Please unmute your line and ask your question.
Yeah. Thanks. Peter Verdult, BNP. Just a few. Some are very quick yes or no answers. Firstly, on the Galvo AD data, you're calling out faster recruitment rates. If they continue, could we actually see that data next year? Question number one. Secondly, the only investor debate until February full year results is going to be BIMZELX volume price trends and compared to the HS data sets. I know, J-C, that you don't guide to individual drugs, in light of today's share price reaction, perhaps you'll make an exception and describe your level of comfort with consensus expectations of EUR 3.5 billion in 2026, and any potential for upside there.
When you think BE BOLD will have an impact on trends, and your thoughts on what looks like flattening NBRx trends. If I could, forgive me, you can always say no. Squeeze in one just on EVENITY. Almost 25% of your profits. In the past, I think, Emmanuel Caeymaex, you've cited that could be a EUR 4 billion drug. Just wanted to explore, is there any life cycle management opportunities to consider here that could extend life beyond 2033? Thank you.
Thank you, Peter. Perhaps I can start with the Galvokimig question. As we've discussed in the past, our aim with Galvokimig's current phase II study is to have a phase III-enabling study that really will inform potential comparator strategies, potential subpopulation strategies. Indeed, recruitment's been accelerating very nicely. As of now, we're looking at early 2028. Obviously, I'm not going to exclude that it could be earlier, and we'll give you an update at the next opportunity.
I can take.
Thank you. Our next question.
I can take the question on-
Go on, Sandrine.
the BIMZELX consensus, if that's okay.
Yeah, BIMZELX and EVENITY. Thanks, Sandrine.
Yeah. As you know, Peter, we do not guide for product net sales, but we can confirm that we're comfortable with where the Visible Alpha consensus is for 2026 as published on our website.
Fiona, do you want to take BE BOLD?
Yes. On the BE BOLD, it's still early days. The data came out at EULAR, which was in June. Response from the market and from physicians is very positive. It reinforces the strong efficacy, the long-term impact that it has in psoriatic arthritis, which, as you know, is a really devastating disease and where, if you don't treat it early with something strong, it has irreversible damage.
It's really early days, but based on the initial reactions from physicians, some markets we can use it proactively, other markets, we still have to wait for the publications. We're very confident that you will continue to see the great performance of BIMZELX. I think it's important to realize it's not only on the rheumatology, but one-third of our PSO patients will progress to PsA, it has an impact there as well. Thank you for the question, Peter.
There's one last question on EVENITY. Do you want to take that, Fiona or Sandrine?
Well, with the partner we have, we cannot guide on the long-term sales of EVENITY, we have not changed on that. True, it's very strong growth, contributing a meaningful part of our overall profitability and has been so, we are confident on the future growth trajectory as well of EVENITY.
Maybe, Peter, one thing to keep in mind that osteoporosis is slightly different than quite a lot of therapeutic areas, where it's a really underserved market. The market potential is really significant, as you've got one out of three women and one out of five men who will have a fragility fracture. People don't take care enough of their bones yet, it's really a market that can continue to grow over time. Thank you.
Thanks.
Thank you. Our next question is from Sarita Kapila from Morgan Stanley. Please unmute your line and ask your question.
Hi. Thanks for taking my question. Sorry if I missed it, just to come back to the emerging competition in HS, how are you thinking about particularly Novartis' remibrutinib oral and potentially coming in earlier than BIMZELX and AbbVie's lutikizumab, and the potential headwind that more entrenched players may create on pricing? Thank you.
Yeah.
Thank you. Go ahead, Emmanuel.
Yes. Thanks for that question. I think it's fair to say that BIMZELX with the dual IL-17A and F blockade is very central in terms of mechanism in HS. From the data that we've seen so far from oral or antibody products in mid-stage development, there is nothing there that suggests stronger efficacy. The question is whether an oral mode of action might represent an advantage and also a broad mode of action. I think HS is, as we all know, a very heterogeneous disease, I would foresee that patients will benefit from different approaches to the HS biology. Let's see how the phase III studies read out.
We've been there before with other products. In terms of the anti-IL-1, clearly the mode of action is promising. We know that IL-1 beta in particular is expressed in HS lesions. However, mid-stage study results do not suggest a deeper broad-based efficacy. However, there are probably segments of patients that will benefit from IL-1 blockade. There's been reports anecdotally from trialists that patients not doing well on BIMZELX were responding well on such a product. To me, it's good news for patients, and hopefully an oral mechanism will also enable to accelerate the market growth. Thank you.
Thank you. Our next question is from Sophia Graeff Buhl-Nielsen from JPMorgan. Please unmute your line and ask your question.
Good afternoon. Thanks for taking my questions. One just on BIMZELX channel mix. How much of a channel mix are you seeing year-on-year? Have you seen a meaningful step up in the proportion of volume through government channels? How much did your assumptions on this change from the beginning of last year versus the beginning of this year? Then maybe just to this point on the heterogeneity within HS, are you gaining further insights into the patients which respond best to IL-17? Are you yourselves exploring other pathways such as JAK/STAT that could address some of the continued unmet need in the indication will be used in combination with BIMZELX? Thank you.
Thank you for your question. We don't share details on exactly how our channel mix is split. What I can say is that we're seeing progression across the board, both on our commercial and government programs. Again, I would say feedback from patients and physicians is really astonishing on the impact that BIMZELX is having on the HS patients. From a heterogeneity, I think it's too early to say for the moment on where there may be a difference. We have as much, I would say, bio-naive as switch patients from different classes. Again, there we continue to see sort of nice progression. Emmanuel, I don't know if you want to add anything from the pipeline perspective.
Yeah, from an R&D point of view, we're continuing to interrogate tissues actually that we collect and to perform mechanistic studies to uncover segments of patients, and figure out how to best bring an approach that either serves more patients or helps patients that are difficult to treat to achieve the same high score and internal results that we've seen with BIMZELX in responders.
Thank you. Our next question is from Xian Deng from UBS. Please unmute your line and ask your question.
Hi, thank you very much for taking my questions. Two please, if I may. The first one is on BIMZELX, this improved mix towards the frontline access. Just wondering if you could maybe give us a bit more color on this particular PBM. As you mentioned, this is one particular player that actually have frontline for everything. Just wondering, is this the same PBM that used to have frontline psoriasis, now it's just frontline for everything, or it's from a different pair? Just wondering, just trying to understand, how should we think about the net price erosion in the second half? The second question is, if I may ask maybe a bit on the BIMZELX peak sales, the EUR 7 billion peak sales.
If we look at the consensus, which is already almost towards EUR 8 billion, which is, let's say, EUR 3 billion each for HS and psoriasis, EUR 1 billion each for PsA and axSpA. Just wondering from your internal projection, just wondering, is there any of the indications that you are actually very different in either way from consensus? Thank you very much.
Thank you very much for your question. First on the access. Just to remind everyone, we had an increase of 36 million lives back in January, then this move 1st of June across all three indications in one of the large PBMs. You will see the impact on net price in the second half. We are assuming the growth of the volume will come with that. I think it's really important as we sort of think about both the short term and the long term. We're here for the long term.
This is a marathon, we want to make sure that we're constantly improving the experience that our physicians and our patients are having and making it easier to use BIMZELX, particularly as they start to prescribe it earlier and earlier in their prescription patterns. On your question around peak sales, our intention is at least EUR 7 billion. We will see where the market takes us. We're seeing strong progression across all three indications. Of course, the three indications are at different stages from a competition perspective and from a penetration. We don't share for the moment how that split will be across our peak sales. Thank you very much for the question.
Thank you. Our next question is from Charles Pitman-King from Barclays. Please unmute your line and ask your question.
Hi. Thanks so much for taking my questions. Maybe a first one just to try and push you a little bit more on the BIMZELX pricing. This has been a key component of the debate today in the market. I understand you hope long-term volumes, just are you able to give us any indicative change in the net price you are expecting across on a kind of global or U.S. level into the 2H, just noting the change seen at 1H? Just anything else you're able to give us in terms of trying to quantify that net price change.
Secondly, just on R&D, noting the strong acquisitions that have been made by UCB over the first half, you obviously have to fund the various trials. They indicated 25% for the full year, imply the high 20s R&D rate by the end of this year. Just wondering, is this a sensible exit rate that we should be assuming for R&D going into 2027? Or should we still assume some phasing on 1H, 2H? Just how should we think about the R&D that's necessary to support your expanding pipeline, given the primary readouts of the phase II, III trials aren't expected till 2028? Thank you.
Yeah, I can take this question. On the net price dynamic, we're not giving trends on the net price, but I think the way to look at it is really the net price is clearly reflecting the access coverage mix, and it's ranging from double step edit to single step edit and now to first line. Maybe to add on what Fiona said earlier, the improved one large contract for first line for all indication is coming from a position where there was no first line previously. That gives you know the difference there is in terms of net price between double step edit and first line. You can certainly form a judgment of what it can mean on how the improved access first weigh on the price and then of course, drive volume growth. On your question on R&D.
We have a midterm view of our focus is really strongly on differentiation and innovation. Our midterm view of our R&D as a percentage of net sales is around 25%. Of course, depending on organic, inorganic can move slightly. Historically, we've seen indeed that there was a phasing between H1 and H2. Typically, that's how we operate decision internal. We tend to design the phase and then start them in the second half. When I look at 2026, there's a lot of life cycle and new phases starting plus the acquisition. I will not give elements regarding 2027. It's too early, directionally, I think the 25% as a percentage of net sales for R&D is a good indicator.
Thank you so much.
Thank you. Our next question is from Charlie Haywood from Bank of America. Please unmute your line and ask your question.
Hi, Charlie here, Bank of America. Thanks for taking the questions. First one's just trying to understand the implied second half EBITDA margin step down in your guidance. I guess firstly, it assumes no gross to net in second half. On two questions, gross margin and OpEx. Gross margin commented to expansion year-on-year. Any magnitude we should consider after what we've seen 1H?
How do you expect sort of gross margin to evolve over the years to come as your growth drivers increase as a percent of mix? Secondly, on the total OpEx growth, we've seen 2% reported growth or mid-single digit CER growth for 1H. Is that a good proxy for how we should think of second half ex your acquisitions? Any sort of magnitude of dilution in terms of total R&D we should expect from the acquisitions to hit in second half? Thank you.
Okay. On the dynamic of H1 and H2, I think you really need to take into account what I've said earlier on the elements which are going to be impacting the difference between H1 and H2 trends. On the net sales, of course, BRIVIACT loss of exclusivity is really second half weighted. If you think about the fact that Europe will be off patents in August, and U.S. went off patents at the end of February.
I think that's one key element, when you measure the two semester. What I've mentioned on the gross to net prior adjustments that's also an element. The other, I would say, potential element to reflect is this improved market access. Because the 1st of June contract, as I said, translates first in higher pricing erosion, while the volume benefit takes a bit more time to build.
Once you look at these different elements, you can better understand the underlying trends between H1 and H2. The translation on the margin and in the gross margin is reflected as well, because some of the big increase in the first half is linked to this pricing effect, which we will not see in the second half. However, as I said, overall, we expect to see an improved gross margin for the full year compared to last year, which means that the mix product effects more than compensate the pricing dynamics.
If I go to OpEx, I will not comment line by line on the trends. I think what you should keep in mind is that there was certainly phasing elements linked to R&D. Even excluding the integration of the new acquisition, we expect more R&D spend in the second half. We will continue to support the growth of our assets, and we will continue to invest in terms of marketing and DTC in the second half. That's why there is also a difference, an asymmetry between the first and the second half expected margin. Thank you.
Thank you. Our next question is from Kerry Holford from Berenberg. Please unmute your line and ask your question.
Hi there. Thank you for taking my questions. Just sticking on the margin. Clearly, we saw that just exceed 40% in the first half of the year. I was wondering if you're prepared to talk about what a long-term sustainable margin is like UCB is going forward, what's an appropriate level there longer term? Second question here on myasthenia gravis. Slightly softer performance than we're expecting in H1.
Wonder if you can give an update on your two key brands there, and the future growth potential from line extensions and how you intend to grow that position in this increasingly competitive market. If I may just squeeze in one final one, a broader point on BD. You've been very busy clearly since the start of the year with various M&A and in-licensing. What's your appetite and capacity as we look forward from here? Thank you.
I'll start with the margin. I think I answered in the previous question that the strong H1 margin should be read as phasing related rather than a new run rate. I hope I explained the factors, explaining what's expected in the second half. In more long-term perspective, as you know, we're not providing long-term guidance on the margin. If I look at our 25 last year margin level, we aim to continue to improve our margin level over time. We aim to continue to grow our top line and improve our margin level over time in a more gradual way. Clearly, reflecting also the higher base from which we are now operating compared to where we were a few years ago. Clearly an ambition to continue to grow top line and margin.
On the MG portfolio, as mentioned earlier, we have a year-on-year growth of 38%. I think the fact that we have two differentiated therapies both in the FcRn and the C5 class, that positions us uniquely to address the heterogeneity of the patients, the snowflake patients, as we call them, with really strong and robust molecules who also can be tailored to both the physician's preference, but also patient's preference with self-admin versus physician administration. Our intent is to serve over time 20,000 patients annually as we progress.
Thank you. Our next question is from Rudy Li from Wolfe Research.
Oh, hi-
Oh, sorry.
Please unmute.
Sorry.
There was one other question there. Yeah.
Yeah. I may t ake the questions of the BD appetite and capacity if you will. Thank you for the question. As you said, the first half of the year I've been quite busy on that extent. From a strategic standpoint, as we were, and we still are, with a very strong execution phase. We dedicated our focus more on the early stage and trying to make sure that we can either strengthen and diversify our platform and modalities and integrated asset in our portfolio at a relatively earlier stage, which is what we did with IMIDomics and with the T-cell engager. Neurona, it's a little bit different, but it's a very small niche. With that in mind, I think you need to reflect about our ability to engage furthermore, with these two components. One is the ability to integrate and to execute.
We have a quite a busy now pipeline and portfolio to develop clinically, monitoring first our ability to manage that through the P&L, as well as understanding what is the best way to phase our future growth, as we are reasonably well-equipped until 2035+. The second element is opportunity. We still have the huge flexibility from a strategic standpoint. Sandrine mentioned it. Despite this recent acquisition, we still have an ability to execute on others. We will not say no to something which is really significant, but we need to pay attention to the ability to integrate, to absorb the impact on the P&L, and making sure that it is strengthening our long-term view.
Thank you.
Thank you. Our next question is from Rudy Li from Wolfe Research. Please unmute your line and ask your question.
Yes. Thanks for taking my question. First, maybe just a quick follow-up to the BD question. Would you continue to focus on early-stage products, or do you consider commercial-stage assets, especially for epilepsy? Secondly, it's about your EUR 7 billion BIMZELX guidance. Maybe can you provide additional color on your current key assumptions, and what can drive additional upside to that number? Thanks.
I can take the first one as a follow-up of the previous one on the BD. As I said earlier, the reason why we are focusing on the early-stage was two. First, it was the ability and the willing to continue to execute on what we have today. We have five growth drivers at relatively early-stage that we want to push in different indications and different patient population, and that keep us quite busy. We need to pay attention to the phasing of adding new patient populations on new assets moving forward. Two, it was also the timing of the additional growth that we were needed. That was the reason of the early-stage at that stage. We don't see in the near future an appetite to move to commercial-ready asset with the current portfolio that we currently have.
Maybe on the BIMZELX, the at least EUR 7 billion, it's really based on sort of the three key drivers. One, of course, execution, every day out in the field, as well as across all the different channels, DTC, improving our access, in a strategic systematic way. Two, it's the key data. We've recently published the BE BOLD, but we continue to enhance our real-world evidence and improve the insights that we get with BIMZELX.
We have a long room. I mean, for the moment, it's still held sometimes as sort of the best for last. We know that these diseases need to be treated early with something very effective. The combination of IL-17A and F really makes a difference in these different indications. Finally, the life cycle that we're working on. PPP, of course, and the adolescent indications. Thank you very much for the question.
Got it. Thanks for the color.
Thank you. Our next question is Michael Leuchten from Jefferies. Please unmute your line and ask your question.
Thank you. It's Michael Leuchten from Jefferies. Two questions, please. One on the DTC campaign around BIMZELX. Looking at the NBRx scripts, it looked like it had an impact, and then it kind of stopped doing it. I just wondered if there's anything special in here that is unusual or whether you have reduced the DTC intensity that would be reflected as such in the NBRx trends. A question on your decision to take the tau antibody forward in context of the Biogen data that we just saw at AAIC, sort of your thinking around antibodies versus other platforms, internal tau versus external tau. It's an expensive program, just interested in that asset at that capital allocation decision. Thank you.
I'll take the DTC one. Yeah, we heavily invest in DTC. We did have a quiet period back in November, which may explain what you're suggesting. We're back in full blast, and we'll continue to have significant investment in DTC for BIMZELX across all indications. Emmanuel, maybe you want to answer any time?
Yeah, for sure. Indeed, we've decided to take bepranemab in a phase II study. I think the Alzheimer's space is really moving into an area of future precision therapies. Over the last year or so, it's become more and more clear that tau is a target of choice, that there is space for anti-amyloid plaque products as well as anti-tau products, potentially sequentially, potentially in some patients even concomitantly. As to the recent Biogen results, on the one hand, we see them as supportive of the tau hypothesis. On the other hand, there's clearly a dose response question.
It's probably comforting our hypothesis that going for extracellular pathogenic tau is an approach that makes sense. I think that's the strategy we've been following, and I think that study is encouraging, but also is asking a few questions. No, we haven't waited for that Biogen study outcome to actually make our decision, right? We've been in contact with the four large regulators worldwide over the last six months to really align on what the features should be of a program and also align on the CMC aspects of such program. That is why we're now in a position to announce that we're taking bepranemab in phase II. Thank you.
Thank you. If our next questions are from the last four people, if you could please limit yourself to one question so we have time for everyone. Thank you. Our next question is from Rajan Sharma from Goldman Sachs. Please unmute your line and ask your question.
Hi, thanks for taking my question. I just wanted to go back to that new contract that you secured in June for BIMZELX. Could you just help us understand the volume uplift there? When you reported full-year earnings in February, you mentioned a 25% increase in covered lives since 2025. Has there been a change there? Thank you.
Back in February, we mentioned a 25% increase because that was sort of the first win with the PBM. Here, what we're saying is we're improving the positioning within one of the PBMs. I hope that answers your question. Thank you.
Yeah, I was just wondering if there's been an increase in the covered lives ex that contract.
No. We're at 80% for covered lives.
Okay. Thank you.
Thank you.
Thank you. Our next question is from Stacy Ku from TD Cowen. Please unmute your line and ask your question.
Hi. Thanks so much for taking our question. Just to follow up on the payer comments. Can you further clarify what's happening with the HS third payer, that at least for the first half was not covering? And when you talk about the favorable dynamics related to gross net, maybe can you talk about that in the context of the roughly 40% of HS patients treated with BIMZELX that are bio-naive? And again, related to the payer dynamics, if you're able to comment on 2027, believe these conversations are now ongoing. Just help us understand your strategy in HS, and in whether it's going to be related to any competitive entrants. Thanks so much.
Thank you for your question. On the HS, as for the moment, yeah, the situation hasn't changed. With the strong efficacy of the drug, we do get a lot of medical exceptions, as well as we have our bridge program, which ensures that we're continuing to ensure physicians are getting more and more experience with the drug and that patients have access to it. As you can imagine, we're under negotiation on a constant basis, and we will see how we progress things. However, for us, it's really important to find that right balance between when do we trade off price versus volume. We'll do that in a very, I would say, cost-mindful way.
Understood. The favorable dynamics for gross net, whether it's related to the HS patients that are bio-naive.
You mean from last year?
From last year that were applied to the first half this year.
I'd say that's, yeah, we don't go into the detail of where it comes from which PBM and which indications.
Okay. Understood. Thank you so much.
Thank you.
Thank you. Our next question is from Qize Ding from Rothschild & Co Redburn. Please unmute your line and ask your question.
Hi. Thanks for taking my question. Just a quick follow-up question on the EUR 7 billion peak sales guidance for BIMZELX. Can you give some color on how much of that is from the new indication PPP and also the pediatric expansion opportunity? Maybe just can I squeeze a second question? On the BCMA bispecific antibody you acquire, can you talk about the rationale for choosing those two indications? Also, do you think there would be some potential indication expansion opportunity for this bispecific antibody? Thanks.
Maybe let me take the first one, and then Emmanuel, I will hand over to you for the second one. On the at least EUR 7 billion for BIMZELX, it is a mix of course, the indications that we have now, the market growth potential of each of those indication, and the further penetration, as well as our three adolescents and PPP. I would say I am not going to speculate exactly on how sort of those are going to progress. If you take, for example, HS, a significant amount of patients are actually their first symptoms take place during the adolescence. As we progress sort of the market awareness and how people are treated with this disease, it will have an increasing impact over time. Thank you very much for the question. Emmanuel.
Yeah. Thank you. On cizutamig, these decisions really are based on data, and the quality of the data, the transformative potential of this molecule, in gMG and in SARD-ILD. As we look forward, there are many opportunities that are very sizable, that we are obviously continuing to study. This is a start, but we will continue to be very data-driven and to keep an eye on the quality of the opportunity, and of course, therefore, the unmet need.
Okay. Thanks.
Thank you. Our final question is from Xian Deng from UBS. Please unmute your line and ask your question.
Hi. Thank you very much, again, for a quick follow-up on the net price BIMZELX comment. Just wondering, if we think, let's say, this industrial average amount of rebate in autoimmune, let's say Gevotec is around 50% for the longer term. Just wondering, because if I remember correctly, this time last year, you already said your Bemi rebate is broadly comparable to that. Just wondering, is your target a bit higher than the, let's say, sector average because of HS? Whatever that level is, just wonder, are you actually very far from that by now? Yeah. Thank you.
Thank you for the question. I'm not going to come on into detail, but what I will say is we are in the industry average, depending on the sort of course, if you're first line, second line, or double stepped, added or excluded. I will let you make the calculation across the indications and the channels. Thank you very much.
Thank you. That was our final question. This concludes today's call. Thank you everyone for joining. You may now disconnect.