Earnings Call: H2 2019

Feb 20, 2020

Welcome to the UCB conference call. For the first part of this call, let me remind you that all participants will be in listen-only mode, and afterwards, there will be a Q&A session. If you wish to ask a question during the Q&A session, please press 01 on your telephone keypad and you will enter the queue. After you are announced, please ask your question. Please note that this conference call will be recorded and that a replay of the webcast will be available later today on the UCB's website under the Investors section. I am pleased now to present Ms. Antje Witte, Head of Investor Relations, who will be the moderator of this conference. Ms. Witte, the floor is yours. Thank you very much, Guillaume. Good afternoon and good morning also from my side. Thanks for joining us for our full year results 2019 conference call. Before I hand over to Jean-Christophe Tellier, our CEO, who will introduce to you also the speakers with him, I like to remind you that this presentation and Q&A session and the presentation slides are under our disclaimer and safe harbor statement you find on slide 2, which I kindly ask you to read carefully. With that, I would like to hand over to Jean-Christophe, CEO of UCB. Thank you, Antje. Good afternoon, good morning, everyone, and thank you for joining our full year results call. As you may have seen in the press release already this morning, we are pleased with our 2019 performance. These are good progress on our strategic growth path, strengthen our ability to deliver sustainable growth. As Antje mentioned, I would like to go through the agenda for this call. Before that, maybe mentioning that with this goal in mind, we are strengthening our operating model to ensure more agility and collaborations across the organization. This evolution is reflected in the new composition of the executive committee that we also communicate this morning in the press release. Executive committee, which became smaller with more transversal roles across businesses and regions, and you have some of the illustration of that in the agenda that is on the screen right now. Taking the floor after me, Emmanuel Caeymaex will comment about our immunology business. We have now included Evenity in our immunology pillar, and in his new role, Emmanuel will be also in charge of the U.S. Then, Charl van Zyl will talk about the neurology franchise focusing on epilepsy. Charles was before in charge of our operation and is now responsible of our neurology pillar, as well as our European and international geographies. Finally, Detlef will lead you through the financials as usual. He will comment the 2020 outlook and our new midterm guidance. As you know and as previously announced, after a very successful tenure, Detlef will retire from UCB during the first half of 2020. As you may have seen on the press release, we are continuing to look for a successor and confident that we will be able to do that before the end of the first half of this year. As you know, our ambition for patients is to allow them to live the life that they want and not to have their life defined by a disease. This is the anchor of what we do, our main sense of purpose, and the justification of our patient value strategy. We are strengthening constantly our sense of purpose in order to reflect commitment for a sustainable development, and this is the purpose of this slide. First and foremost, we want to focus on innovations in R&D, which means for us, and that's our patient value ambition, it means for us bringing differentiated solution with unique outcome to help specific patients populations to achieve their goals, but also create for them the best possible individual experience. On top of that, it means also broadening access, and this is the second pillar that you see here on this slide. Access to the patients who may need the solutions we can propose to them in a way which is viable for them, for the community, the society, and for UCB. Value for patients, and it's the third pillar, value for the patients means also offering to UCB employees the best environment for them to be at their best, and in particularly in terms of health, safety, and well-being. Finally, we want to deliver this while minimizing our environmental footprints across the entire value chain. Building on this journey, where are we today? As you may remember, in 2019, we entered into our second phase of our strategic path, the accelerate and expand phase. We wanted to accelerate on our cycles and develop agility. We wanted to expand in new patients populations, and we also wanted to leverage our strategic flexibility, identifying and acting on potential opportunities. What have we delivered in 2019? First, we have added 2 new products in our portfolio for new patients population. Evenity with our partner Amgen in osteoporosis has been launched in U.S. and Japan and approved in South Korea, in Australia, Canada, and in Europe. This is a first-in-class innovative bone builder therapy in osteoporosis. 7 new products that we have added to our portfolio. Nayzilam, we launched in December in the U.S., a nasal spray for seizure clusters. We have also, and that's the second element that you see on the slide, we have also continued to accelerate and significantly strengthen our pipeline with already 3 positive phase III clinical trials for bimekizumab in psoriasis, and 5 new phase III programs have started in 2019. Bimekizumab in psoriatic arthritis and axial spondyloarthritis. Padsevonil in refractory epilepsy, and rozanolixizumab in myasthenia gravis and immune thrombocytopenic purpura. Last but not least, we have also leveraged our strategic flexibility that we had in our priorities. Last October, we announced and reached an agreement to acquire Ra Pharma. We wanted to join forces to improve our options for the treatment of people suffering from myasthenia gravis and other rare disease. Charles will comment about this later on. But, as we shared with you and we want to confirm that we are confident that we will be able to close this deal in Q1 2020. But acting on potential opportunities and connecting with different partners possible. It's also achieved through other elements, and you have few examples here. We have created a pioneering five years genomics R&D collaboration with the Epilepsy Society to better understand the disease, creating a new taxonomy and potentially better understand biomarkers and how to develop more appropriate treatment for sub-patients population. With SeizeIT, we have granted a consortium project agreements to develop a discrete and personalized epilepsy seizure-detecting device. And with King's College London, we have signed a three years R&D collaboration. So you can see that we are not only looking about external opportunity from an M&A perspective, but we are also strengthening our potential collaborations with other key stakeholders in the areas of our interest. So we are progressing well on our pathways and we are building our future. But of course, we are able to do that mainly because we are delivering on our key growth drivers. And it's because of the result of today, it's because of the performance of today that we can continue to strengthen our sustainable future. Building on the sixth consecutive year of growth, top and bottom line, with a revenue CAGR of 8% and a EBITDA CAGR of 19% over the period that you see on the slides, we have built a very strong platform for the future. So, and you have here the main results, pair products in terms of growth and absolute numbers. Then Charl and Emmanuel will comment furthermore. That have guided us to improve our midterm guidance. So we are pleased with the strong 2019 performance. We are pleased that we have been able to continue to grow, that allow us to accelerate our pipeline, allow us to build and strengthening our future, and delivering sustainable value for patients. So with that in mind, I would like to hand over now to Emmanuel. Thank you, Jean-Christophe, and thank you all for joining. I'm very pleased to comment on the performance and the progress of our three immunology assets, including Cimzia and its growth drivers, an update on progress and context for bimekizumab, and also on the launch of Evenity. So let's start with Cimzia and the components of the strong 14% constant currency growth that you have seen, and also how this is leading us to increase our peak sales guidance for the brand to EUR 2 billion. So the first point, it's important to note that the 2019 growth is entirely volume driven. So there is no positive contribution of net price. All geographies have been contributing to this growth, as you can see. And in the U.S., both the Lyophilized formulation as well as the PFS presentation have been growing. So, as you know, Lyo is for in-office injection, and we've had substantial market share gains there, owing to very good first-line access, but also a very strong value proposition with a room temperature product that can be injected rapidly compared to most infused products in the category. It's important to note also that use and coverage of the Lyophilized formulation is not purely Medicare Part B. In fact, 40% of this formulation is covered through commercial insurers, and that is the fastest-growing part of the two. What was great in 2019 is to see our prefilled syringe grow again, and that's been fueled by our launch in psoriasis as well as the early launch of non-radiographic axSpA. We've opened a lot of access for those patients, and I look forward to next year to see this fully translated into our sales growth. It's noteworthy also to see that Europe has been growing despite indirect competition of biosimilars affecting both net price and volumes. That growth is really down to a few points. The first one is Resilience and further increasing shares in the women of childbearing age segment, which is increasingly recognized as a segment of patients in need of specific solutions. The second one is the early days of our psoriasis launch in Europe. International markets have been strong across, as you can see. We're very pleased with that, and it's for the same reasons as Europe. If we now look on the right-hand side, you can see that the growth drivers in terms of patient populations, besides women of childbearing age that I mentioned, and that cuts across our psoriasis with about 4 points as a new entry. AxSpA, which is both non-radiographic AxSpA in the U.S., but also a general halo effect with the great data that we've been able to generate and communicate last year across the world. Looking forward, we are confident that Cimzia will achieve or exceed EUR 2 billion peak sales. We consider that the multiple growth drivers will more than compensate for volume and price erosion linked to subcutaneous TNF biosimilar competition outside the U.S., and also for the new modes of action centering the various indications. Just to recap on Cimzia, we have psoriasis, where Europe and Japan will contribute to cash sales in the future. We have AxSpA, where there's a lot of runway, a lot of unmet needs, and a lot of market shaping to do, especially in the U.S. Further gains, and certainly resilience in the women of childbearing age patient segment, where Cimzia is not readily substitutable, represents a third source of future growth. I believe that the in-office injection segment in the U.S. also have room for further market share gains, as well as our geographic expansion with a very promising start in China, which today is a small market, but a market of strategic importance longer term. All of this is good preparation and a strong foundation for us to build on as we prepare for submitting and eventually, hopefully, marketing bimekizumab in both dermatology and rheumatology. As you can see here, bimekizumab is now in 4 late-stage clinical development programs totaling 10 studies across phase III and IIIb, and we're adding hidradenitis suppurativa as a target indication for bimekizumab, and I'll come back to that a little later. But perhaps first, as a reminder, bimekizumab is a monoclonal antibody which potently and selectively inhibits two cytokines, interleukin-17A and interleukin-17F. We know that in human IL-17 biology, both 17A and 17F have pro-inflammatory function, and that they both synergize with other pro-inflammatory cytokines such as TNF, for example. So blocking both A and F should lead to more patients achieving sustained, clinically adequate responses, achieving their goals. This is what the phase II study suggested, and that is what we aim to confirm with the ongoing phase III studies. Psoriasis has been advancing very well with the three out of three in the fourth quarter last year. We are very excited with this, and we are also very pleased to share with you that the detailed results for the first two studies, BE VIVID and BE READY, will be shared in late-breaking oral presentations at the American Academy of Dermatology on March 21st this year. This includes the superiority study versus Stelara, as well as a placebo study evaluating dosing down the product. The full results of the third phase III study, BE SURE, became available after the AAD submission deadline, and so we plan to share these results in the second half of the year at a major dermatology medical conference. I can also reconfirm that we are expecting the results of the BE RADIANT superiority study versus Cosentyx by the end of the second quarter, which should be just before we submit bimekizumab with American and European regulators in the summer. The PsA and axSpA programs, which started last year, are recruiting to plan, and we are expecting to plan results by the end of next year. We are pleased that the PsA phase IIb results have been published earlier this month in The Lancet. It is available online already. It is clearly a high profile and a high impact factor medical publication, and this recognition of the potential of the clinical relevance of dual neutralization of 17A and 17F in psoriatic arthritis is very encouraging. Now a quick word about hidradenitis suppurativa. Let us call it HS. It is an area of profound patient unmet need. We look forward to making a difference for these patients and their providers. It really is a debilitating chronic inflammatory skin disease of the hair follicle with painful lesions and often abscesses in the armpits, the genital area, the groin, buttock, and breasts. It actually is not uncommon. The global prevalence is estimated to be close to 1%. This disease typically starts in the early 20s, predominantly in women, and it is associated with multiple comorbidities, including anxiety, depression, embarrassment, as well as other inflammatory conditions. So patients are not well-served by the healthcare system and also not pharmacologically, where only one drug is approved for this condition, and that is Humira. So it really is an emerging area, but an area of really very high unmet need. The basis for our phase III program is the successful phase II proof of concept study, which we conducted with bimekizumab. The results were clearly positive. We shared them at a recent Hidradenitis Suppurativa meeting, the European HS Foundation meeting early February. Based on these very encouraging results, we are starting two identical one-year placebo-controlled studies as we speak. And we are testing three dose regimens of bimekizumab and allow Humira prior exposed patients to be included. The question could be, of course, in a large growing and competitive space, how might we assess bimekizumab's potential? There are probably important factors that we should consider when selecting a medicine for these patients across these diseases. We invite you to look at four factors. The first one is that there is significant intersection and progression across diseases, certainly between psoriasis and PsA, that is well recognized, but also between psoriatic arthritis and axSpA. There is intersection. There is an emerging set of scientific articles that point to axSpA patients suffering from HS and vice versa. Maybe not in large proportions, but certainly in the range of 10%. That perhaps points to common pathobiology, which should be encouraging for a drug like bimekizumab with its axSpA phase II-B results. If the phase III and III-B data confirm our findings of phase II, bimekizumab can be regarded as a very attractive option across the spectra of these diseases by healthcare professionals, but also by payers. Next to that, of course, and thinking about the first indication that will hopefully hit the market, psoriasis. We are also looking at speed to meaningful response. Often for patients, it takes months before knowing whether the injections they are taking actually work. There is the depth of response as well. Can we fully eliminate the symptoms and enable patients to completely forget about their disease? The fourth criterion could be the durability of the desired clinical effect, because there is a lot of anxiety of symptoms coming back, and that is certainly an area which clinicians are constantly complaining about, is the loss of efficacy with many of the available agents. This kind of rounds it up for bimekizumab. Let me perhaps briefly share a few points about Evenity, which you might also have heard in the Amgen call if you participated. As Jean-Christophe said, Evenity is an innovative bone-forming treatment for post-menopausal women with osteoporosis and at a high risk of fracture. It affects 75 million people in the U.S., Europe, and Japan, and one in three women over 50 will suffer a fracture. Despite this being common, only 20% of fracture patients currently receive any type of treatment post-fracture. There is an enormous unmet need here. The question, of course, is who is at the highest risk of a major osteoporotic fracture? Clearly, it is those women who have had a fracture that then have a five-time higher likelihood of suffering a second fracture within the next year or two. That is quite an important marker, and that is also where we are positioning Evenity together with our partners, Amgen and Astellas. These fractures can be life-altering events and therefore really demand action, not just in terms of treatment, but also in screening patients and making sure that patients get sent to the appropriate physicians. With Evenity, it is more about getting patients identified and treated than about displacing other medicines. We think that with its fast and unprecedented bone-building results and fracture risk reduction, Evenity can be seen as a 12-month treatment before then transitioning to chronic therapy. We are very pleased with the December EMA approval and with the success of the launch so far. Close to 55,000 patients have already been treated with Evenity in 2019 in Japan and in the U.S. And we plan and are ready to launch Evenity in Germany in March with the support from Amgen and to gain access across Europe during the rest of this year. To conclude on the immunology portfolio, we have strong growth with Cimzia. We look forward to further growth in the years to come based on multiple drivers. With bimekizumab, we have unique mode of action that is translating to attractive clinical results, and we look forward to sharing the phase III results and discovering the phase III results as we go. And Evenity is off to a very strong start in underdeveloped markets, and it's really an important long-term commitment that we have to these patients. And with this, I would like to hand over to my colleague, Charl. Thank you, Emmanuel. First of all, good morning, good afternoon to everyone joining the call today. I'll make some quick opening remarks before I go into some more specific details. First of all, I want to express my confidence around how we're building a very diversified neurology franchise in the short and mid-term. And there are three important messages I want to just convey and three important building blocks for our neurology franchise. First of all, we are starting off with a very strong foundation in epilepsy, and we see the short-term to mid-term growth continue to be fueled by some of our core brands in our epilepsy franchise. Secondly, in the mid-term, we see also a very nice expansion into neuroinflammation, which is an area of rare diseases with a high degree of unmet need. And here we have two very strong assets, in this case, rozanolixizumab as well as our acquisition of Ra Pharma, with two modalities that could give us some strong positions in rare diseases and a variety of unmet need areas for the future growth in this area in the mid-term. And finally, in the long term, we have a very strong foundation in neurodegeneration. Clearly, we have a legacy in Neupro and a deep understanding of Parkinson's, but we also have a very strong scientific competency and understanding of this area, which leads us to some new treatments, potentially here with the confirmatory study also for anti-tau in PSP. So over those three horizons, we see a very nicely balanced position in short term as well as mid and long-term growth. And I feel very confident that we are in a strong position over the next years in our neurology franchise. So if we go a little bit deeper into the discussion on epilepsy, and I just want to again here express my confidence around our position that we have in epilepsy, and we are really here seeing a very strong portfolio of choices for patients and for physicians to treat the different stages of epilepsy. We have a very strong position in the controlled area with brands like Vimpat, our legacy of Keppra, and also strong emerging growth of Briviact. Then we have a new launch, as Jean-Christophe had mentioned, in the area of seizure relapse with Nayzilam in a very high unmet need area, and we see some very strong performance and early results there that give us confidence that we have a real winner in this particular area called seizure relapse. Finally, during this year, first quarter 2020, we will also reveal more insights into padsevonil, which we believe will address an important area of refractory patients where there's a high unmet need as well. When we think about our epilepsy position today, we have a strong portfolio that is generating for us options and solutions for many patients across a wide range spectrum, as well as a very strong position on a geographic level, which I will speak to in a little short while, where we also see the foundation of our growth across all our key geographies. Therefore, with this position we have being a trusted leader, a very strong foundation that we have in legacy as well as in our future offerings. We are very confident that we are in a position to continue to fuel the growth in the short to mid-term from our epilepsy franchise. If we spend a little bit of time just going into Vimpat, which is one of our key growth drivers, I want to express three reasons why I'm very confident that we can continue to see this nice growth path for Vimpat in the short term. First of all, the profile of Vimpat is very broad in terms of mono as well as add on. It is really the trusted choice for many physicians today. We see a broad prescription across a large number of physicians. It's really their first go-to for the early stage treatment, and it's really a trusted brand based on its very favorable tolerable profile and clearly, of course, the efficacy that it provides as well. Second reason why we are confident is when we think about our engine across our different geographies. You see that on the right-hand side, we have a broad position of presence in all the geographies with our patient numbers illustrated there. We see here again, also very strong growth across all our regions. We're very clear on how we deliver that growth with a very strong basis. Predominantly, our growth is driven by volume with some price, but we see that as being one of the foundations for continued growth. The fact that we can generate new growth through new volume and new patients with our offerings that we have today. Finally, the third reason for that continued growth is the life cycle management that we see expansion into new geographies, Japan, China, and also new indications that we've listed there with regards to submissions that we will have in the first half of 2020. I am therefore very confident at this stage with what we have in our hands to be able to continue to see this growth going forward. We are therefore very confident that we can increase the peak sales from EUR 1.4 billion to a EUR 1.5 billion guidance based on our current evidence that we have. If we then just conclude on epilepsy and just to give you a very quick, again, conclusion, we see that this is 50% today of our net sales of UCB, and we have a very strong track record of growth, as you see there, 14%, or on a constant basis, 10%. It is very much driven by our leading brands, Vimpat and also Briviact. Those two offerings are continuing to show very strong growth as we see them in the midterm, and we will continue to see the execution of each of those in all the geographies delivering that growth that we want in the short term of at least high single digit to double-digit growth. As you have heard from Emmanuel Caeymaex as well, today, we have 50% of our business in epilepsy, but we also see our position diversifying the midterm with, of course, the additional growth in Cimzia, the launch of bimekizumab, and also our position in neuroinflammation with the launches that are upcoming in rozanolixizumab and Ra Pharma. Those seven launches that you have heard Jean-Christophe Tellier talk about will diversify our position very much in the midterm. In the short term, we are very confident about the growth we can deliver and contribute from the epilepsy franchise. With that, I would like to make some remarks on rozanolixizumab. Again, here, as I mentioned in my introductory remarks, this is the new, or let us say, the future vector of growth for us in neuroinflammation. It is a clear asset that we see as a potential to address a large number of patient populations. We have started development in three of those, as you see there. But we believe there is potential for additional patient populations that could be addressed with rozanolixizumab based on a broad platform that we have of IgG-mediated diseases. Complementing that is our second modality, which is Ra Pharma acquisition, that will give us a different molecule, not a monoclonal antibody, but a peptide that will have a different mode of delivery and also a different mode of action in complement inhibition. When you put those two together, we feel very confident when we look at our platform that we have on rozanolixizumab as well as Ra Pharma, that we can diversify our neurology footprint and our position into rare diseases in areas of high unmet need and also where there is lower competition. Just to give you a sense of rozanolixizumab, clearly we are focused on developing in a broad range of patients. But we see certainly in the market of plasmapheresis, which is today an area where most patients are receiving their treatment, that there is a high unmet need there. Patient preferences for alternative ways to deliver potentially subcutaneous at the place where they choose, and we see rozanolixizumab living up to that promise and being able to address that market, which is today estimated around EUR 11 billion in plasmapheresis. A strong potential opportunity for us in the future there. Then finally, I would like to conclude on Ra Pharma, just to say some words on Ra Pharma. As you would have heard from us before when we signed the deal, we see a very strong rationale for this acquisition. It fills important components for us in our long-term growth in neurology. First of all, it fills a very clear gap in giving us the potential to lead in myasthenia gravis with an option that allows patients to be treated in a more maintenance phase or a controlled phase with zilucoplan. We see that very nicely then complemented also with rozanolixizumab in stages where patient needs are more in refractory stage, where they need more intermittent treatment. We see those two options really providing many solutions for patients to be able to treat myasthenia gravis in the most effective way going forward. Secondly, as I mentioned previously, the rozanolixizumab franchise and platform, together with Ra Pharma, gives us two modalities in rare diseases and really gives us the opportunity to expand into new patient populations that we have not been able to treat before. The third important component of this deal is that it provides us a very strong scientific platform. We are very pleased with the scientific foundation of Ra Pharma and really the ability of the macrocyclic peptide platform to be a potential discovery engine for us will be an important element of this deal as well. Finally, it allows us a stronger strategic footprint in our Boston healthcare space, which is an important ambition that we have as well to be present in that important space in the U.S. Before I hand over to Detlef, I will just again conclude and leave you with the three important messages of why we're very confident around our neurology franchise. Firstly, epilepsy remains a very strong foundational growth. We're very confident around our trusted leadership position there across many geographies to be able to deliver the sustained growth in the near term. Secondly, neuroinflammation with rozanolixizumab and also the Ra Pharma acquisition give us a very strong position to broaden our patient populations into rare diseases. Finally, our longer-term position with our strong scientific base in neurodegeneration and with the anti-tau molecule going into confirmatory stage, we believe we also have a strong position in neurodegeneration in the mid to long term. With that, I'm going to hand over to Detlef to take us through some of the financial positions. Thank you, Charles. I have to say that the financials are very good. Besides that, a bit boring when you compare to what Charl and Emmanuel were able to display in terms of what we are doing at the moment, but what we can do also in the future. Let me lead you to the main topics here, just for completeness. We achieved revenues of more than EUR 4.9 billion, as promised earlier this year, which is 6% growth, 7% on a constant base. So very nice and mainly driven by core products. When you saw the presentations, I think you got a sense of this and got a sense of the strong growth that we have been experiencing and that also have led to a very strong year of finish. When you look at the operating expenses, it is not a surprise in the situation that we are in with launching, with preparing launches, but also having a broad pipeline in phase III, that our expenses are going up. We had 10% more R&D expenses within our guidance. We had 15% increase in marketing and selling, which makes sense in terms of what you heard of the launches and also the impact that these launches had. We have taken the opportunity of a good year also to invest in all the growth pockets that we could see to really take advantage of our strong offerings. That has left us still with a very positive REBITDA, recurring REBITDA of 29.1%, which is slightly above the corridor and slightly above what we are guided. It is over proportionally on the constant rate, which is the more telling variable here. When you look to profit, one thing that might have surprised you a bit was the tax rate. This is also very easy to explain. We have been, and have been talking to you about our tax strategy and being prepared to take advantage of the different patent boxes, R&D credits, and with a bit of luck of tax reforms like they happened in the U.K. and Switzerland this year. That is exactly what has happened. With more profit, more opportunities of these tax opportunities come in. That is why these incentives were given also by the different countries to spur innovation. Earnings per share then are more or less a result of that. Over proportional growth, same like profits with EUR 5.2 per share. I would like to bridge to really 2020 with two slides. The first one is about the growth that we have been experiencing consistently over the years. Jean-Christophe has referred to it, so I will make only one point on that. We have been telling you that we will have to invest more. We have invested more, but we have also managed well and therefore have been able, despite increasing R&D and despite increasing sales and marketing, to still keep the REBITDA percentages high. The next slide is more about investing into the right things. What we have been trying to tell you is that we are very conscious about that we have to reallocate the monies to the right things. When you look to the left side of the graph, then you see that cost of goods have been going down. R&D has been going down until two years ago when we started into the preparation of our acceleration and expand phase with this broad pipeline that you see today. Marketing and selling is more or less one year later, where we are taking advantage of these products now coming to market. You have seen the launches in that year. When you see G&A, we see no peaks there because we are getting more and more efficient and with more sales, this can also be achieved. We want to leave you with this impression, I hope that you anyway have, that we are managing towards impact, and this is a good investment for the future. On the right side of the graph, it is something to be celebrated, at least internally. We have reached net cash this year after long years of being in net debt position. We will change that quickly with the expected Ra Pharma acquisition. A substantial part of that firepower that is created out of that is going away, but there is a bit of firepower left that can be used for the right things. Also here, investment into the right things and preparing yourself so that you can do that by real good reallocation. It leaves me with the midterm guidance and the 2020 guidance. Let us start with 2020. Before we forget that, this does not include the Ra Pharma acquisition. As we have not closed on it, this would not be opportune. The revenue that we are foreseeing is EUR 5.05 billion to EUR 5.15 billion. It has continued strong core product growth which you might not feel all the time when you look to the number, but there is more than these core products. There are established brands, there is supply in terms of manufacturing for the divested products, there are divested products, and there is also CapEx that is starting to erode more. Do not let yourself be tricked into this would not be ambitious. This is a good guidance with the parameters that I just offered. In terms of our EBITDA, we are expecting 28%-29% of revenue. When you have in mind that we are close to 26% today in 2019, we are now thinking that it will be 28% plus minus 1% for R&D in the coming year, which already explains to you that we are making still good progress on the reallocation and keeping the profitability. Core EPS is a resulting number more or less out of this, and we are expecting 480 to 520. The tax ratio should be staying somewhat around the mid-teens for next year. I would also encourage you to see this as a good number, a good range for your mid-term models. There will be fluctuations up and down, but when you want to model, this would be not too bad to do. Which brings me to the mid-term guidance. EBITDA revenue ratio of 31% will be 2021. Do not forget, we said it will move to 2022 when Ra Pharma will be closed, but we have given these numbers without Ra Pharma. Therefore, we are also moving back for this time. Peak sales will be more or less the same for Briviact and Neupro, and Charles van Zyl and Emmanuel Caeymaex were already talking about Cimzia being at the level of more than EUR 2 billion and Vimpat at the level of more than EUR 1.5 billion as peak sales. With that, I would like to conclude, leave you with the feeling and hopefully also your impression that these were very strong numbers and that we have delivered in the different things that we did want to deliver, and hand over back to Jean-Christophe. Thank you, Detlef. We are now at the end of this presentation. I hope you have seen through the different presentation from Charl, Emmanuel, and Detlef, the strong results in 2019, and also the confidence in the future. The future starts tomorrow, and you see here for 2020, the different trigger points that we have. It will be a rich year in terms of continuation of acceleration of the pipeline with the various step for rozanolixizumab, bimekizumab and alpataselin. You see also here the closing of Ra Pharma at Q1. The submission of bimekizumab in psoriasis at mid-year, as Emmanuel mentioned, and also another phase III starting in lupus with dapirolizumab in first half of the year, and our anti-tau UCB0107, phase III that will start in Q2 that we have not mentioned yet. You see strong year, good performance delivered, confidence in the future. This year, continuation of the acceleration of the pipeline and important trigger point as we continue to strengthen our future. You know that our plan is to launch up to seven products by 2025. This notion of six or seven is, of course, linked also to the acquisition and the closing of Ra Pharma. That's the reason of the six. We have already two launches done with Evenity and Nayzilam. This will help us to fulfill our missions to deliver sustainable patients value for the patient that you can see here as an example, Anika, Christophe, Wendy, Victoria, Lloyd, and Caroline, and so many others who aspire to live the life that they want, which is also our aspiration to be able to deliver that for them. And with that, this close the session, and I would like to open now for your questions. Just before opening to the questions, I would like to let you know that Iris have also joined us and will be available to answer your questions. Thank you. Thank you very much, Jean-Christophe. William, if you can start the question and answer session, please. Yes. Ladies and gentlemen, we will now begin our Q&A session. If you wish to ask a question, please press the code 01 on your telephone keypad to enter the queue for the Q&A session. We already have a question from Peter Verdult from Citi. Please go ahead, sir. Thank you. Peter Verdult, Citi. Three questions, please. For Detlef or Emmanuel, just on understanding the profitability flow through to UCB on Evenity, especially in light of the drug sales ramp far exceeding expectations. You booked roughly about $10 million of other operating income on 150 odd of sales. Look, the drug's on track to do more than $500 million. I mean, our back of the envelope calculations Implies that could flow through to at least EUR 100 million of other operating income coming through. I realize you are not going to talk exact numbers, but anything you are willing to share and help us better understand sort of the flow through on profitability there would be very helpful. Moving to the pipeline, for Charl, JC, or Iris, padsevonil data coming up next month, I believe. I think historically this drug has been positioned as treatment refractory epilepsy. When we speak to the docs, the profile that sort of was hinted at the phase II-A comes through, without any big issues with cognitive disorder. The message we are getting is that this could be a sort of add-on of choice or second add-on of choice. I just want to understand from a UCB positioning, is padsevonil a sort of Briviact sort of niche product, or could this blue sky be a sort of Vimpat replacement? Then lastly, Detlef, I am sad to think this might be the last time we hear your dulcet tones on the conference call. You have built a good reputation over the years, guiding conservatively at the start of the year and always coming up with higher EBITDA and a tax rate way below guidance by the end of the year. Is it safe to assume with your successor yet to be announced that the spirit in which you have approached giving the guidance for 2020 is particularly conservative this year? Thank you very much. Thank you, Peter. Emmanuel here. I will start with answering the Evenity question and invite Detlef to jump in. Our partnership with Amgen is a 50/50 profit split partnership. We have a partner in Japan, namely Astellas. The costs and the rewards that go to Astellas for the piece of work they do, is subtracted from the profit pool before we share it. That is what I can tell you at this point. In terms of future, of course, it will depend on the ramp-up as well. The price point for this agent is different than for biologics in autoimmune, for example. Relatively, the COGS is a little higher than you would see with biologics. Detlef, anything to add here? No, I think you made it perfectly clear. So on patisiran, maybe- I can start and- You can start and then- Yeah. Thank you. Thank you, Peter, for your question as well. The inclusion of criteria for patisiran was really in refractory today, and we see, as I showed in my slides, 25%-30% of patients are in this refractory segment where there is a high unmet need. So that will be our core initial positioning. I think we will learn more as we understand the data over the next months if there is a potential broader usage. But certainly today we see it strongly in the refractory space where there is a very high unmet need. So Iris, please add if you would like as well. No, there's not much to add. Peter, as you remember, padsevonil combines two of the most potent mechanisms of action in epilepsy, synaptic vesicle blockage plus a GABA A receptor interaction. It's only natural that we have selected those patients who are in most need for the initial treatment opportunity with padsevonil. You might also remember that the International League Against Epilepsy defines patients who have tried more than two anti-epileptics and have no satisfactory treatment response as drug resistant. We are enrolling in our clinical studies patients who have tried at a minimum four anti-epileptic medicines and still are not controlled. We're really, in the clinical trials, studying a highly drug-refractory patient population, and that in combination with a very potent mechanism of action should give us unique outcomes that have not been demonstrated before. We will see results before the end of this quarter, and that will give us a basis for discussion in a data-driven way, and that's the next big step. Thank you, Iris. Peter, if I may say, you have asked your questions about the spirit of the guidance in a very elegant way. Detlef, I would be curious to hear your perspective on this. Yeah. Peter, thank you very much for your perspective. I appreciate that. I have approached the guidance more or less as always. Not a lot of change. As you know, we are giving in this guidance the benefit of taking the risk on FX rates. We are taking the risk on very volatile interest rates, and therefore, we are approaching it with what we believe can be delivered for sure. Our track record shows that the company has always delivered. I would expect also that we will deliver this guidance, and if things would run as well as we saw that in 2019, which was a bit better than we were expecting, otherwise we would not have had to do the financial guidance update, then possibilities. However, we are in an investment phase, and that also means that, I mentioned that before, that we try to take any opportunity that we have throughout the year also to reinvest. So in that regard, I feel today very comfortable that this is a guidance that we can achieve as we have achieved the others. Our product portfolio is strong, therefore, we hope to have a bit of opportunity to reallocate in opportunities when they're coming. I mentioned before, perhaps that might have been lost, that the top line, I read in some of your comments, and it's very understandable from people who looks a bit cautious. But when you think that we probably have to see each for Keppra established brands, the other revenues, royalty lines and divestments, an impact of roughly, let's say around 1%, then this takes another dimension. Then you are, I think it was quoted 2.5 to 4.5, is moving up to something that looks much more in line with what you would expect from our core products. So in that regard, no, I'm very happy to also leave a guidance that can be achieved. But that is also not one that isn't given under old. Super helpful. Thank you. We have another question from Richard Parkes from Deutsche Bank. Please go ahead, sir. Hi. Thanks very much, Phil. Let me have a few questions. I would also like to say best of luck to Detlef, and I certainly don't remember you missing the guidance in 13, 14 years I've been following the stock. Thanks very much for that. It's been very helpful. My question is firstly on Evenity performance. I'm just wondering if you could talk about to what degree we're seeing a bolus of sales in the most severe patients. Can you talk about how new patient starts have continued to evolve since the launch? That's the first one. Secondly, on the anti-tau antibody, obviously there's other drugs that have failed in PSP. I wondered if you could talk about how your compound compares and what evidence you have on brain penetration and target engagement based on the data you've seen so far. I know you were looking at partnering in Alzheimer's disease and just wondered if that was still ongoing. Third question is on bimekizumab. Obviously we'll see the phase III data at AAD. You've outlined where you see the points of differentiation. Could you talk about based on the data you've seen internally, does that continue to support your optimism of demonstrating superiority to Cosentyx on PASI 100? Thank you. Richard, Emmanuel here. I'll take your two questions and my answers might be a bit disappointing, but on the first one, Evenity, I'll have to guide you to Amgen. We've agreed with them that the commentary on the markets that they're releasing is going to be for them to make. Obviously you're right to ask the question. It's a 12-month treatment, so we will need to renew the patients very regularly, and that's why we're investing across the world in ensuring that more patients are seen and are treated. In terms of bimekizumab, I'm afraid somebody else have to wait for the AAD detailed results. Thank you. This is Iris. I would like to respond to your question regarding our tau antibody and our confidence of the efficacy in PSP. You mentioned the failures of competitor developmental efforts. As you know the pathology in PSP are tau tangles, and we have designed our tau antibody in biological experiments with human material. We have learned from these experiments that addressing a central epitope results in different efficacy in terms of preventing the spread than when you address peripheral epitopes. The two molecules that you mentioned that just announced failed clinical studies are addressing peripheral epitopes while our antibody is addressing a central epitope. If you talk to our researchers, it was expected to see that failure in other molecules, and it's kind of a validation of our approach. Of course, we still have to demonstrate that the blockage of the central epitope will be efficacious. You also asked about target engagement, and please rest assured that we have almost complete target engagement at the doses that we're taking into our confirmatory study. I think while we all agree this is of course a high-risk program, we have confidence in our data that has led us to go from phase I directly into a single confirmatory trial. Based on everything that we have seen so far, we believe we have an antibody that holds high potential of being efficacious in this patient population who are very desperate and actually confronted with a death verdict when they get their diagnosis. I would like to leave the question on Alzheimer's partnering to Charles, if I may. Yeah. Thank you, Iris. To be clear, we do continue to look at partnering in Alzheimer's. But our primary focus, as Iris had stated also, is in really the development in PSP where we see the primary value of this asset. That's where we will focus. However, broadening the opportunity with a partnership would be something that we continue to talk to different possible interested parties as well. Okay. Thank you. Okay. Jo, can we have the next question, please? Yes. Next question comes from Trung Huynh from Credit Suisse. Please go ahead, sir. Hi, guys. Thanks for taking my questions. I have two product ones and one modeling question. Firstly, on padsevonil, can you clarify the definition of refractory on slide 16? In that chart, you showed 25% of people living with epilepsy are refractory. Is this segment of patients that have failed four-plus antiepileptics? When it comes to labeling, will you try and get a label for refractory patients, or given both your late-stage trials are in four-plus failures, would this be the population? Secondly, I might be reading too much into this, but the zilucoplan myasthenia gravis data, that is posted as 1H 2021. You previously said the data should be expected early 2021. Is there a slight delay there? Finally, to Detlef, thank you very much for your help over the years. I appreciate your leaving, but can you help me one last time on your midterm cost levers, given we are one year closer to your 31% margin target? On COGS, is there any opportunity for gross margin improvement here? You did 80%-82% in two years. Does 82% represent a ceiling before your patent expiries? On SG&A, can you help with the growth of your marketing spend as you launch Evenity and Vymea? Finally, on R&D, thanks for the 28% ratio for 2020. As we move forward, you are going to have higher marketing. What sort of R&D growth should we see given you expect to have margin leverage going forward? Thanks very much. Okay. Thank you for your question. I will start with padsevonil. As Iris had mentioned earlier on the call, refractory definition is really failure on two antiepileptic drugs. In this case, for padsevonil, we are setting a very high hurdle of efficacy with inclusion criteria for patients that have failed on four antiepileptic drugs. Clearly our label today and our intended label will be very much focused on refractory. We see that is essentially a third of the market of patients that still have a high unmet need, and our focus there will be to position padsevonil on the initial label to treat these refractory population. I think your second question on Ra Pharma and the timing, this is consistent with what Ra Pharma has publicly stated. We have not changed that position in terms of readout of zilucoplan. Back to the modeling. I think you got it right. Both in the cost of goods and the G&A, we have still a little bit to go, which is just also the composition of the portfolio. However, I have to say, and it's not a surprise, that our R&D expenses in the next one to two years will still go up, which leaves us then also understanding why we shifted the year from 2021 to 2022 because this potentially additional, let's say 2%-3% in R&D that is coming on top of what we need for our own late-stage pipeline could not be compensated. And that would then also bring it down a bit in the years in between. However, the marketing and selling, there is a ramp-up that is crystal clear that we have seen already now. We will see that going into the next one to two years for the key products. But we are also starting to see some opportunity with the overall product portfolio to reallocate, and that will take some of the edge out of this. So we are comfortable on the 31%, whether it's 2021 or 2022, depending on without or with Ra Pharma, and I think I have the feeling we'll make it again. By the way, for the ones that already did that, thanks for the very kind words. I will keep them with me and have them in mind. Always a pleasure. Thank you. Our next question comes from Wimal Kapadia from Bernstein. Please go ahead. Thanks very much. Wimal Kapadia from Bernstein. Just following up again on padsevonil. How much importance should we actually place on the phase II data ahead of the phase III next year, just given that the trial design size actually looks quite similar? Is there any possibility of filing on phase II-B data, just given the high unmet medical need? Just tied to that, you're clearly going after refractory population. Is it fair to assume high share, high price? Because I think it's around 10% of epilepsy patients actually have failed four antiepileptics. So, could we assume a relatively high share in that population? My second question is just on the upcoming, well, in two years time, the impact of genericization. Just to get a sense of whether we should really be using Keppra as a good benchmark given that it was a true gold standard at a larger installed base, was approved across multiple indications. So is it actually a good benchmark for how to model Vimpat genericizations, or should we expect the decline to be somewhat faster? Thank you very much. Yeah, thank you very much. I start with your padsevonil question, and you're absolutely right that the phase II-B study that will read out towards the end of this quarter is a very substantial study, 500 patients across different doses of padsevonil versus placebo. The study is indeed quite similar to the phase III study, similar patient population, fewer doses that we are testing in that study. So it's two adequate and well-controlled clinical trials. It is very clear that regulatory authority will insist on two of these studies to accept the submission. Our very early proof of concept study, you might remember, was very small, just 50 patients. So that would not qualify in the eyes of the regulators as an adequate and well-controlled study. So we are very clear that we will need both studies for an acceptable filing to the regulators. I have a lot of empathy for your statement that the unmet medical need might lead us to believe differently, but we know very clear from agency feedback that that's not the case. Perfect. Just to follow on to that, at this point, I think it's a little early to comment on price until we learn more about the profile, which we will certainly evaluate over the next months as we go forward. Then on to your second question on how would you model the LOE of Vimpat. There is obviously some differences. Keppra had a lower competition at the stage of when it went off patent. Today we see with Vimpat and the environment that we face with increased cost containment that you would probably see a slightly higher erosion of Vimpat than of Keppra. So, that's how we would give you that guidance at this point. We have another question from Richard Vosser from J.P. Morgan. Please go ahead, sir. Hi. Oh, excuse me. Hi, thanks for taking my question. A few questions, please. Firstly, just thinking about your 31% guidance in 2021, which is the same as last year. You have upgraded the Cimzia guidance and the Vimpat guidance since then, has clearly more sales. I obviously understand that there is things to invest in, but they sound relatively limited in terms of R&D, and you'll be finishing some trials. So just a question, why that 31% margin? Why the need to clarify Ra Pharma into 2022, why that hasn't actually gone up? So, that's the first question. Second question, and apologies if this has already been batted back, but I think I heard that Evenity in Europe, where you will be in charge of the marketing, you might be able to comment on. So perhaps you could give us an idea of the opportunity you think there for 2020, and also a few years out. Then the final question is on hedging losses within the sales line. Just could you give us an idea of the hedging, maybe plans for 2020 and how to think about it? Clearly, there's not much of a currency benefit in 2020 at current rates. So we should be expecting lower losses, perhaps. So just some thoughts there, and some more detailed thoughts there. Thanks very much. I can take the two questions that are more financial nature. There is this trick. When you look at absolute numbers and they are rising and you keep the percentage equal, you are tricked into believing the absolute number is also equal, but this is rising with it. That is the first part of it. The more important part is, it's a very fair point to say this is overall going up. There should be more money that is coming down. On the other hand, we also know much more than before, in terms of what we have to do. We have additional clinical studies that we are starting, that might not have been involved before. We are feeling that we can compensate that by the improving top line and the profits that are coming by that. It has not gotten easier due to the success of the portfolio, but we are compensating by what I would believe good management and increasing top line. On the FX, I think you're absolutely right. The FX at this moment is a little better than what we saw end of the year and what we saw throughout 2019. At this moment in time, from a hedging perspective, we are running slightly ahead of the game. However, this will be very marginal if it would stay this way. I would not focus on that. We'll take that throughout the year, seeing what fluctuations will be there, and if there's something that can be added, we will add it as usual. Richard, on Evenity in Europe, as you know, access and pricing and reimbursement needs to be obtained in Europe. For 2020, the only sizable market to which we will have full access to is Germany. Germany is also the most underdeveloped bone builder market in Europe. My guidance would say that contribution this year will be rather incremental in comparison with Japan and the U.S. Over time, of course, Evenity has significant potential in Europe, but it is something that will take a number of years to play out to an extent that would be really significant in light of a much more developed Japanese market and a U.S. market with different characteristics. Thank you very much. Next question comes from Peter Welford from Jefferies. Please go ahead. Hi. Yes, thanks very much for taking my questions. Thank you, Detlef. Just a few questions. Firstly, with regards to rozanolixizumab. Looking on clinicaltrials.gov, it looks as though there are now two ITP studies. I do not know if this is just some sort of error in the website, but I am just curious. It does look as though you have also slightly delayed the ITP readout timeline relative to prior expectations. Should you just comment at all as what is going on there? Secondly then, just on bimekizumab, I am curious whether or not in HS, did you consider doing a head-to-head versus Humira? If not, why not? I guess, given obviously you have done that in other indications, and it would seem like perhaps an obvious choice given that that is the only approved therapy, you could then be the clear winner. Thirdly then, looking at Evenity, going back to Europe, I wonder if you could comment at all. Presumably you have had some initial thoughts already on Germany with regards to price. If you could give us any sort of insights there, that would be much appreciated. Thank you. Peter, on rozanolixizumab in ITP, I want to confirm that one phase III study has started, and that is so far our plan. I will go back to clinicaltrials.gov and see what ambiguity there might be. But the confirmation is one study in ITP. To your question about data readout, as it just has started, I am not sure that we have given any date already. Second half 2022. 2023. 2022. 2022. Second half 2022. Thank you. On bimekizumab, thank you for your question. There are actually several factors here. The first one is that we aim to reach the market rapidly, and quite a few patients in our proof of concept study could not be included because they had been exposed to Humira. We have decided to let those patients in because this will probably represent the state of the field by the time we get there. The second reason is that we actually included a Humira reference arm in the proof of concept study, which was reported recently in a conference. We were quite encouraged by the potential for a deeper response on certain endpoints with bimekizumab, which is not unlike what has been seen in other indications, seeing 75% or 90% symptom reduction score, DLQI 0/1. We believe that getting to the market rapidly with an asset that has a significant level of rate of deep responders is going to be sufficient in such an area of unmet need to gain access and to be successful commercially. In terms of Evenity, the way it works in Germany is you are launching at a list price, and then within a year or so, you have your AMNOG price. I do not really wish to comment on the list price to start with, because it is not really going to be meaningful long term. That is great. Thank you. Next question comes from Charles Pitman from Redburn. Please go ahead. Hi. Charles Pitman from Redburn. Thank you for taking my questions. Firstly, if we assume the BE RADIANT study shows bimekizumab with superior efficacy to Cosentyx, what would be the hurdle to achieving standard of care status in psoriasis? In that case, would you need to partner to commercialize it? Could peak sales grow to be larger than Cimzia in the long term? Secondly, could you just help us with any color on initial physician uptake of Nayzilam? Thanks very much. Charles, thank you for your question on BE RADIANT. Yeah, clearly, the reason why we've picked Cosentyx as a comparator is that it is a drug with a high market share, and it's the most used of the IL-17A inhibitors. At the very minimum, the asset would then be regarded as a superior option to what has almost become a standard of care in the field. Would we need to partner bimekizumab? I think the advantage we have with our focused entry with Cimzia in psoriasis is that we've established a capability in psoriasis which we can easily scale across the U.S., Europe, and Japan. We have a lot of experience also in terms of the clinical development and medical affairs angle. I believe that our access capabilities, in particular in the U.S., are strong now, as you've seen also from the increased Cimzia results and guidance. I wouldn't say that should be a base case scenario at all. Then you had another question related to Sorry. Peak sales. Oh, peak sales. Yeah, it is way too early. Thanks for asking. Charles, to your question on Nayzilam. It is a little early to get new prescription data as yet, given that we launched essentially two months ago. I can give you just a couple of points. Estimated patients in the U.S. that have a risk of seizure relapse is around 120,000 patients. We have today an estimate of around 1,000 patients in the first two months. What is driving a lot of the early success is unrestricted access. Between 40% and 50% of our accounts have unrestricted access, and we see that trending upward very quickly. So, a very promising start and it is obviously first in class and the broad adoption that we see within the community is very promising, but too early to really give you a clear read yet on the peak view of this. Okay? Thank you very much. Next question comes from Sandra Cauwenberghs from KBC Securities. Please go ahead. Hi. First, my sincere congrats to the whole team for the nice progress that you made in 2019. I still have three small questions left. First on bimekizumab. You will start a phase III trial for fourth indication. This is still in the skin inflammation space. I was wondering if outside of dermatology and rheumatology, do you see any additional benefit of this drug in other inflammatory areas, or will you stay focused for now on these two segments in inflammation? The second question is on zilucoplan. You've mentioned earlier the plasma fractionation market or the apheresis market. Can you elaborate a little bit on the potential positioning of this drug? Will you limit yourself potentially to these orphan disease indications, or do you see broader applications? Then the last one is with regard to Neupro. I think this is already on the market since about 14 years. Do you still see an interest in continuing to pursue this particular market? Thank you. Thank you, Sandra, and thank you for your question. On bimekizumab, we intend to focus indeed on rheumatology and dermatology indications. With the strong position of Cimzia in spondyloarthritides as well as RA and our entry in psoriasis, I think we'll be in a good position to make the most of bimekizumab's impact for patients. To your question on zilucoplan and the positioning. Typically what our learning is of the MG patient today is that they start on normal steroids, and then if they lose control, they would go into a situation where they need other interventions. We see zilucoplan being very much the follow-on from steroids to a stage where they need greater control, and that we see rozanolixizumab playing a strong role where there is periods where they are out of control or in refractory or exacerbations, where they would need to have rozanolixizumab. And in that space where we talk about rozanolixizumab is really where patients are today on IVIG, and that is the opportunity that we see to potentially provide alternative solutions for patients and the preference for patients there, at least from our learnings, is to have a subcutaneous infusion at the place where they would like to have that, at home or in the office. We see the two, zilucoplan and rozanolixizumab, coexisting very nicely on that continuum of care for patients with MG. Then your second question on Neupro. Today, the treatment modality for Parkinson's is really mostly symptomatic to address the motor symptoms. We are clearly in our future view of neurodegeneration, want to address potential of disease modification. Our science and our focus on research is really in that area of really trying to intervene earlier to have a better outcome for patients, and that is where we will continue to focus in that space. Thank you. Next question comes from Jean-Jacques Le Fur from Bryan, Garnier. Please go ahead. Yes, thank you for taking my question. A quick one on Cimzia and the peak sales. You mentioned EUR 2 billion regularly during your comments. But it is just EUR 300 million more than you achieved last year. Last year you already achieved close to EUR 300 million more in just one year. Isn't it a bit conservative to have this EUR 2 billion as a peak sales? Is it fair to assume you have some chances, even great chances, to beat this EUR 2 billion peak sales, let's say by 2024, 2026? Thank you. Thank you, Jean-Jacques. Between 2019 and 2018, we had cash growth of a little more than EUR 200 million. The FX rates played a part, not a predominant part, but at least 20%. This can always reverse, of course. That's one thing to bear in mind. The second one is that whilst we are growing in a number of segments, we're also decelerating in some others. It's really in those areas that we're differentiated, that we're going to grow. All of that should more than make up for the difference by EUR 300 million. I think that with that, the FX rate, we're offering you something that we're confident we can achieve. That should also be meaningful enough for you to significantly update your models. Thank you. Our next question comes from Emily Field from Barclays. Please go ahead. Hi. Thank you. At the beginning of the year, there was a lot of enthusiasm around the Momenta M254 hypersialylated IVIG proof of concept data in ITP, and thereby the effects that could have to competition for FcRns and IVIG as well in ITP and CIDP. I was just wondering if you could make any comments on that data or perhaps more generally just on anything that you've seen in the indications outside of MG, which you've spoken a lot about for rozanolixizumab. Then just secondarily also just on the upgrade to the Cimzia peak sales guidance. Have you changed at all any of your assumptions in terms of what you would be seeing regarding the U.S. biosimilar landscape? Is the sales increase really more predicated on just continuation of trends that you're seeing in Cimzia with sort of the same underlying base assumptions on how Humira biosimilars will play out? Or if anything has changed regarding those assumptions. Thanks. On the Momenta question you had, we do not comment on competition at this point. I would just say that there is a high unmet need in the plasmapheresis space, and so we welcome more innovations there for a large number of patients. At this point, we would not like to comment on that particular question. Emily, thank you for the Cimzia question. It is a good question. Our U.S. biosimilar assumption as to the entry of adalimumab remains 2023. The upgraded guidance is independent of this. No change to our assumptions there. Our last question comes from Thomas Gill from Degroof Petercam. Please go ahead. Hello, guys. Thank you for taking my question. I have a couple just on bimekizumab and Cimzia. Could you maybe elaborate a bit on the synergies you see in terms of SG&A for both products and what midterm impact should we expect? Also, in terms of cannibalization potential between both products? That's my first question. My second question is on the oral zilucoplan or extended-release version of zilucoplan. When should we see that on clinical development? My last question, in terms of design of your ITP trial versus your peer competitor, evacuzumab, maybe could you elaborate a bit on the potential difference you see in terms of targeted population? Thank you. Thank you, Thomas. Perhaps to frame the question on potential synergies between bimekizumab and Cimzia, I should first clarify that there's going to be a more or less at least two years gap between our entry in dermatology and rheumatology if everything goes well. We would probably expand our dermatology coverage to be able to successfully launch bimekizumab. So I wouldn't factor in too many synergies as far as the launch in psoriasis is concerned. Perhaps there can be some later when bimekizumab gets introduced in axSpA and PsA. But frankly, we haven't really looked into that in great detail, and I don't think it should be a driver. So hopefully that answers your question in terms of the costs. Then in terms of co-positioning, I think it's a little early. We first would like to look at the totality of our clinical results across indications before deciding how we might possibly co-position both agents. But of course, you know that Cimzia is associated with advantages for the women of childbearing age population, which are linked to its molecular structure and specific trials we have done, which are unlikely to be reproduced in the same way for bimekizumab. So that's giving you something. Thank you, Thomas. Thomas, to your question on oral zilucoplan, obviously, we are very happy that the Ra Pharma organization has the ambition to develop an oral, and this obviously will be a great choice for patients But today it's too early to really comment on that until we have joined forces after closing. And also your question about the ITP study design, I think it's a classical study design. We are recruiting patients with confirmed ITP, who despite standard of care, have a low platelet count. And we believe that with rozanolixizumab in this patient population, we will be able to unfold a sustainable treatment effect, meaning bringing their platelets above count of 50,000, which would be the threshold for reduced bleeding risk. So that's in a nutshell, the patient population that's being enrolled. Okay, thank you. I would like to close this Q&A session with two questions from the web. The first one from Alex Tor, Cross Current. Do you have any proof of concept data in humans in any of the indications you are pursuing with bimekizumab, that bimekizumab is clinically superior to other IL-17s? And the second question is from Alex Makakawi, I hope I pronounced that correct, from Ostrom. How will you fund Ra Pharma acquisition? What is your net leverage goal after the acquisition? A midterm to long-term goal. So on bimekizumab, no. We don't have proof of concept studies in humans. So it's based on reading across and significant work with statistics and modeling. Concerning the leverage, as we are net cash at this moment in time, if you are just taking EUR 2 billion, you are ending up somewhere around 1.5. When you are taking the guidance into consideration, as I mentioned already last year, there is also some extraordinary cash outs that we will have for our manufacturing and R&D footprint, probably more than EUR 600 million in the coming years. That will add to it, and we still reserve the opportunity to do the one or other smaller topic. The general idea is to stay below 2, which does not mean that that has to be all of the time. In that phase that we are just in, and from a very long-term perspective, a 1 to 1 would be very nice. However, it always depends on the opportunities. I think we have been showing that we are willing to go up to 3.5-4, if that is really needed and we have a short-term opportunity to bring it back. We have no problem to be cash positive for some times if we are not seeing the right opportunities. Somewhat in between it will be, and the 2 is probably a good one to keep in mind as an overall wish that we would have. With this, we conclude today's call with the Q&A session. Thank you very much for your interesting questions and for your interactions. Looking forward to see you out there in London, Paris, Brussels, wherever we go in the next couple of months. I hope you have a great day and a great afternoon. Thank you very much indeed. Ladies and gentlemen, this concludes today's conference call. Thank you all for your participation. You may now disconnect.