UCB SA (UCB) Earnings Call Transcript & Summary

Ladies and gentlemen, welcome to the UCB Half Year 2020 Conference Call and Video Webcast. [Operator Instructions] Please note that this conference call will be recorded and that the replay of the video webcast will be available later today on UCB's website in the Investor Relations section. I am pleased to hand over to Mrs. Antje Witte, Head of Investor Relations, who will be the moderator of this conference. Mrs. Witte, the floor is yours.

Thank you very much. Good day to you. Welcome to our new format of our half year results 2020. We have representatives of the Senior Executive Committee here for you to answer your questions. First, we have a presentation prepared. Please note that these presentations and the following Q&A session is covered by our existing safe harbor and disclaimer slide, which you can see here, hopefully, on the screen. [Operator Instructions] Thank you very much. And I would now like to hand over to Jean-Christophe Tellier, our CEO.

Thank you, Antje, and good morning, good afternoon. It's a pleasure to welcome you on our webcast. As Antje have said, it's a new format. So hopefully, it will be -- it will allow you to ask all the questions that you want and making sure that we have these interactions as much as possible valuable for you. This is the agenda for this webcast. I would like to start with the new name that you see on this slide, Sandrine, our new CFO, that I'm -- my pleasure to introduce to you. Sandrine joined us 1st of July. So I think it's almost her fourth week now being with us, and she is already part of this call. And we feel like she is now a very warm and welcome part of the organization, and we are looking forward to continue to engage with you with Sandrine. You have seen her resume. Sandrine's background in finance is pretty impressive. She has been the CFO for Proximus for the last 5 years. And before that, she was with SFR and Vivendi when she hold various leadership positions, both in France and the U.S., covering finance, strategy, innovations and being exposed to digital transformation. As you can see, all of qualities and experiences that in the current environment is very precious to have. And on top of that, she started as a financial analyst. So for those of you, you will find with her someone who understand what you need in case also. So it's really our pleasure to have Sandrine with us, and I really feel very privileged to have her in the team right now. But before hearing from Sandrine, you will get some update on our pipeline with -- clinical pipeline with Iris. And then Emmanuel and Charl will cover both, respectively, our immuno franchises and neurology franchises. But let's get started with the overall overview of what we have shared with you this morning. And as you have seen, we are very pleased with our ability to continue to grow despite very uncertain times, and the resilience of the portfolio during the pandemic have been translated into an ability to continue to grow 9% at constant ex rate with revenues gaining up to EUR 2.5 billion -- reaching EUR 2.6 billion during this first half. The pandemic had been a disruption for all of us. I think it's fair to say that during this time, we had to look at 4 different pillars for us. One was making sure that our employees were safe and well supported. The reason for that is that you cannot really fulfill your missions and try to engage continuity of care for the patients if you are not able to operate in the best possible way. So that was really the first focus. And being disciplined towards how to engage and safe measure and to rotate people to ensure the continuity of critical tasks such as productions or research have allowed us to ensure the continuity of care, which was really the second pillar of what we were doing during the COVID-19 pandemic, keeping the patients at the heart of everything we do and making sure that all the patients could get the product and the treatment they needed in order to avoid them to be exposed to an additional risk on top of the risk of the pandemic. And I'm happy to report that during the first 6 months of the year, all patients would have been able to continue to have care and to get the access to the drug that they needed. We were able to increase supports to patients where it would have been possible. The third element was really supporting our communities. It started, of course, with local communities everywhere we were a presence commercially by helping the environments. It's continued by making sure that where we have more significant presence. We were engaging with government and health authorities to see how we can help. And I just would like to illustrate that with a few elements. One was, for example, here in Belgium, the ability to transform a part of our platform in Braine to do some testing and diagnostics of COVID, even though we were not equipped for doing that at the beginning. We recalibrate our PCR machines, and we were able to positively answer to the government here in 3 weeks by refocusing our material testing, calibrating, validating with the government and starting to test the patients here in Belgium within 3 weeks. We also refocused some of our manufacturing sites to produce at the beginning [ ethyl alcogel ] when it was missing. So just a few examples of what we have been able to [ do to ] support our communities, making sure that we can take care better of the patients, victims of the pandemic. But the final element of that was the creation of the funds that we want to dedicate to vulnerable people facing the potential issues of being infected and suffering from the pandemic. And last but not least, despite the fact that we were not involved and we are not involved into diagnostic testing or normally into vaccine, we have been able to join global forces to help the science to progress and to accelerate the potential solution that, as an industry, we want to deliver to communities. And through partnerships with academics, with biotechs or being able to offer some of our capabilities for testing and for engineering through CMCs, monoclonal antibodies, we have been able to help also there. Last but not least, we review our portfolio to see if some of our products could be helpful. And zilucoplan, the product that we have acquired from Ra Pharma, are now tested in the ARDS disease potentially here in Belgium and also in the U.K. And finally, we are part of the U.S. R&D COVID communities to try to see how we can help. So you can see that during the COVID-19 pandemic through these activities on the 4 pillars, which could be perceived as something that come on top, actually, for us, came as something which was very consistent with our patient value strategy because when we say we want to create value for patients, of course, we want to create value for patients, first, through our ability to innovate, to develop our portfolio, to potentially acquire new molecule, accelerate the differentiation of our pipeline. We want also to make sure that the patients have the best possible experience and making sure that when they are facing the pandemics, we are able to help them to face this new situation while being treated with our patients -- with our product and also making sure that they continue to have access. And we think that this patient value strategy, which start with the better connectivities between the patients and the science, is an illustration of what we want to achieve in any time and particularly, for the future. If we want to be a sustainable company, we need to connect all of this with an ability to improve our impact on environment, continue to provide access and ensure the well-being of our people also. And this is really what we have started, that you can see that in the next slide. What we have started on our strategic path in 2015, which we are now moving into the second phase, which is Accelerate & Expand. Accelerate, meaning accelerating our ability to deliver new medicines for patients and to potentially expand into new categories of patients population that we want to serve. And we are doing a good progress. And I think when you look at the deliverables for the first half of the year on all of the different pillars that I have highlighted, you can see here that we have been very active despite the pandemic. First, the solidity of our core product brands, but don't forget that we have also launched new 2 products. Evenity in Europe have been launched in the middle of the pandemic and are just starting and Nayzilam who have been launched in December '19. So it's the first year of the product in the U.S. We have also strengthened our pipeline and strengthened our ability through research and development to differentiate our pipeline. You see here on this slide, the new acquisition of zilucoplan and Staccato Alprazolam as well as the different Phase III program that we are -- we have started or continued during this semester. But I would like to illustrate that for me, all of that is also part of the strategy to, through innovations, reduce the risk and build strong platform for future growth. The pipeline have been increased by new products, Ra Pharma and Engage. The ability to differentiate have been more demonstrated by the Phase III result that we have been able to publish like the bimekizumab result that you have seen last week. And I'm sure that the rest of the team will comment on that. But the ability to very quickly and in a sustainable way, we are able to completely clean the skin of psoriasis patients versus the standard of care, what we have demonstrated last week with the BE RADIANT survey study after the 3 of the study before are unprecedented. And then we continue, of course, to focus on where we want to deliver by making sure that we are divesting drugs that are less important for our portfolio. And you have seen -- you see here with Niferex and alprostadil, that most recent divestment. But also very innovative deals that the co-promotion deal that we have done with Ferring to make sure that our U.S. operational people are really focusing on rheumatology and dermatology and leave behind that -- that will be now taken care of by Ferring. So you see all of that, a very good illustration of our strategy in the first half that not only illustrate the strategy but continue to strongly deliver on our promises. And with this, now I would like to hand over to Iris that will comment a little bit more on our clinical portfolio. Iris?

Yes. Thank you very much, Jean-Christophe, and greetings to all. Indeed, I would like to take you on a tour of our clinical stage pipeline, which is growing and progressing. Actually, it has grown now to 10 assets in clinical stage development, which is unprecedented in UCB's history. And it is progressing despite the unprecedented impact of the pandemic. And I'm very grateful to our teams who have demonstrated resilience, who have invested tremendous effort and who have innovated to ensure that we keep our clinical studies going and that we have an impactful restart of our clinical recruitment activities since early June. We've digitalized heavily. We have established tailor medicine, home nursing visits, just to name a few innovations that we have implemented throughout. So let me walk you through the details of our pipeline. We start with bimekizumab. And you see in the first line, submission in psoriasis in summer 2020. I'm very pleased to share with you that our marketing authorization application for the European Union and our Biologics License Application for the United States have gone into EMA and FDA earlier this month. Typically, we would share with you the filing of our regulatory dossier, so the acceptance by the regulatory authorities. And we will do that with a press release when the moment comes most likely in September this year. But I thought as we are together today, it's a unique opportunity to enjoy this very delightful moment of the submissions that went in. I'm also pleased to report to you that the ongoing Phase III programs with bimekizumab. And don't forget, we are talking about 6 very large comprehensive Phase III studies. So the ongoing Phase III programs with bimekizumab remain on track. We continue to recruit patients living with psoriatic arthritis, with axial spondyloarthritis and with hidradenitis suppurativa. And we are very confident that we will deliver the top line results according to the original pre-pandemic time lines. Today, I can share with you for the first time UCB validated time lines for zilucoplan, the complement C5 inhibitor that joined our pipeline through the acquisition of Ra Pharma. The myasthenia gravis Phase III trial will report top line results end of 2021, and that's a result of our internal assessment and, of course, some impact by the pandemic. We continue to expect top line results from the proof-of-concept study in immune-mediated necrotizing myopathy in the end of first half of 2021. Our rozimab development program in myasthenia gravis was affected by the pandemic. When we recruited for our FcRn inhibitor, we were really hit in the early stages, very vulnerable stages of enrollment when the pandemic started. And we have also run the study in geographies where we had an extended impact of the lockdown. You can imagine that we are working very hard to remedy these consequences, but I think it's fair and accurate if we announce that top line results will only become available in the first quarter of 2022. Again, we will do everything we can to make up for this delay, but this is the reality reflective of the pandemic impact. However, I'm very pleased to report to you that the Phase III program with rozimab in immune thrombocytopenia will read out according to the original time lines in the second half of 2022. And the same applies to the proof-of-concept study in CIDP, where we expect results in the first half of 2021. Dapirolizumab, our CD40 ligand inhibitor developed for the systemic lupus erythematosus, is about to initiate the Phase III program, and this is why we can now share with confidence for you the top line results, which are expected in early 2024. Staccato Alprazolam is the latest addition to our epilepsy portfolio and has truly the opportunity to change the way how epilepsies are treated by interrupting an ongoing single seizure very rapidly. Staccato Alprazolam came to us with the acquisition of Engage Therapeutics and has completed Phase II with a successful end of Phase II meeting with FDA. However, we still need to engage with other regulatory authorities around the globe. And there's work packages that need to be delivered before the asset is Phase III-ready. That's why we forecast Phase III with Staccato Alprazolam to start in the second half of 2021. UCB0107 is our tau antibody, which we develop in progressive supranuclear palsy. And as you all know, PSP is a very severe and ultimately lethal movement disorder. There's no treatment option available for these patients. And so innovation is in high demand. Thankfully, FDA has engaged with us in work on creating and -- actually it's co-creation with the agency, a very robust novel endpoint that will combine function and survival. And so we have an opportunity to really launch our Phase III program with our tau antibody in PSP with an endpoint that will set a new standard in this area where innovation is in such dire need. Due to the work on the endpoint with the agency and due to the pandemic impact, Phase III will start in second quarter 2021. And then you see that we have also noted 4 projects that are going through Phase I. This indicates to you that our Phase I units are up and running again, which is good news. And it also indicates to you that there's a constant flux of potentially differentiated new molecules from our colleagues in research into the pipeline leading, as I said earlier, to 10 molecules now in clinical stage development. You will have to allow me to dwell a little bit longer on bimekizumab. You have seen the BE VIVID results before, and I cannot resist to ask you to enjoy them again. Bimekizumab has been consistent in 3 dimensions of its performance. What you see is a very rapid onset of efficacy. You see a depth of efficacy that is remarkable with 85% of patients achieving PASI 90 after only 6 weeks. And then it has a duration durability of efficacy that is outstanding. We are seeing more than 60% of patients achieving PASI 100 and maintaining this complete skin clearance throughout the study duration. And as you have seen last Friday, the saga of bimekizumab continues, and we have -- again had the readout of a very important study. BE RADIANT has demonstrated that bimekizumab is superior to secukinumab Cosentyx on all primary and all prespecified endpoints. So again, a clinically very meaningful result and very consistent with what we have shared with you before. So we now have a huge package of bimekizumab data that is tremendously relevant, showing superiority over 3 comparators: adalimumab, ustekinumab and now also secukinumab. However, I have to admit that whenever we talk about bimekizumab efficacy, we do it in terms of numbers and graphs, and that's quite abstract. Please let me share with you how this efficacy actually translates into the lives of patients. You see here a series of photographs from a study participant on bimekizumab in one of our clinical trials. On the left side, the picture gives you a very good impression what a serious devastating skin disease psoriasis is. You see the thick scaly erythematous plugs. They are very often itchy, bleeding, painful. And I think it's very obvious, this is a stigmatizing disease. Vast areas of the body, not only the back that you see on this picture, are covered with the skin erosions. This patient then received bimekizumab and after a single dose at week 4, you see already a very profound improvement of the skin that would be equivalent to a PASI 75 response. And after only a single further dose at week 8, this patient had almost clear skin, PASI 90 response. Well, this is what we mean when we talk about rapid skin clearance. And then if you go to the 2 pictures on the right, you see what the lasting response mean. This patient achieved PASI 100 complete skin clearance at week 16. And this tremendous response was maintained throughout the course of the study until and including week 52. And I ask you to compare the picture on the right, with the complete clear skin, with the picture on the left at baseline before bimekizumab. And I think it illustrates to you that skin clearance, complete skin clearance is what ultimately patients should aspire because this is the freedom from symptoms. This is the state that removes the stigma from the disease, and that's ultimately desirable. And with bimekizumab, we have shown that a high proportion of patients can achieve complete skin clearance in the long term. And with that, I hand over to my colleague, Emmanuel Caeymaex, who will talk more about delivery of patient value.

Thank you, Iris, and good afternoon, good morning, everyone. So no better introduction to discuss how our immunology solutions have been contributing significantly to UCB's Accelerate & Expand phase in the first half of this year. We're focused on serving those patients who can most benefit from our differentiated offerings. And for Cimzia, this has meant a resilient performance at the market share gains in the first half of this year in the United States and in international markets. For Evenity, we've had some favorable access-related developments in the first half of this year, some pre-reimbursement use as well after the COVID-19 lockdowns eased. Amgen will comment tomorrow on the performance in U.S. and in Japan, where they are the territory commercial leads. We have strengthened and derisked our late-stage immunology pipeline to a significant extent with bimekizumab, demonstrating the straight superiority to the 3 most recent psoriasis market leaders on endpoints that matter to patients, payers and physicians at all key time points investigators. And beyond bimekizumab in psoriasis, we now have 6 Phase III indications for programs running, each aiming for clinically meaningful innovation in meeting patient needs. I would like to point out that indeed [ dapimab ] is moving into Phase III as a first-in-class anti-CD40 ligand agent. And after the failure of Stelara, the high unmet need in lupus is persisting, and we're very pleased to be partnered with Biogen with this program. We haven't spoken much in the past about zilucoplan in a type of autoimmune myopathy that is characterized by severe proximal muscle weakness and myofiber necrosis. The point here is that complement activation drives muscle necrosis, and this is the first foray with such a mode of action in this rare disease. And more broadly, the acquisition of Ra Pharma expands our options space in immunology to meet patient needs that go beyond neuroinflammation and with applications across many specialties, including rheumatology, dermatology as well as acute care, and shared care is not uncommon for some of those disorders across the various specialties. And finally, as mentioned earlier, we are very pleased to have entered into a co-promotion agreement with Ferring, a company that shares many, if not all, of our values for the co-promotion of Cimzia in Crohn's in the U.S. I think it will benefit everyone with augmented support to gastroenterologists and their patients and will enable us to focus our commercial efforts on rheumatology with a large non-radiographic axSpA opportunity as well as dermatology as we prepare for the bimekizumab launch. So when it comes to bimekizumab, we did set and actually have achieved our target product profile. And we set it with the competitive nature of this market in mind. So we've been pursuing unique outcomes, and we'll go for the best possible experience for patients. And we'll start engaging to ensure access for those patients that will most benefit. I think you've seen this slide before. Clearly, in diseases where there's overlapping pathobiology and a lot of comorbidities, it is important to offer a solution that caters to a large spectrum of these potential comorbidities. In addition, Iris has illustrated the speed of onset, as measured by PASI 75 response at week 4, the depth of response at week 16 with a completely clear skin in a majority of patients across our programs, and the durability of this effect. So with this, we feel that there's a very strong clinical foundation to offer a transformative experience to psoriasis patients. And I must say that we're also very pleased with the way our every 8-weeks dosing regimen has been performing in studies so far. So we've been building out access capabilities, are entering into prior information exchange meetings with U.S. payers and are preparing the health technology assessment submissions worldwide. We have been expanding our current dermatology footprint and continue to attract very strong dermatology leadership talent across the world. But of course, another question is, how are we going to supply bimekizumab. And with a substantial derisking of this molecule and the advances of multiple monoclonal antibodies in our pipeline, we have decided to invest in mammalian technical development and have started the construction of a large-scale mammalian drug substance manufacturing facility in Belgium. It will supply bimekizumab to market from 2024 onwards as part of a multi-sourcing strategy. The facility will be digital-ready and minimize environmental footprint. And the integration with our bio pilot in Belgium will ensure short lead times to take transfer and thereby accelerate the bringing of our future medicines to patients. Now moving over to our marketed assets. Cimzia grew, as you saw, by 7% at constant rates. This is all volume growth. Overall, across the world, net prices have been stable. Whilst the COVID-19 pandemic has costed us a few points of growth in Europe and the U.S., we are very pleased with the fundamentals. We continue to beat the TNF market growth despite the availability of TNF biosimilars. And especially in the United States, we've had particularly strong rheumatology growth and performance, driven by our non-radiographic axSpA indication, but also by improvements in benefit verification, making this process as seamless as possible for patients and physicians. The U.S. prefilled syringe and the lyophilized formulation have both grown by about 10%. And the in-office injection markets and our share in that market continued to grow significantly. In fact, we had 20% growth in the first quarter. Versus last year, the second quarter was flat, which thinking about what's happened is a good result, and we've seen a very strong recovery in June after a slow month of April and May. In terms of the prefilled syringe, rheumatology is very strong. As you have heard, I'm sure, with other companies reporting recently, the dermatology segment has been impacted more than the rheumatology one, and gastroenterology is somewhere in the middle. In international markets, we're continuing to grow with substantial market share gains. I think it's fair to say that the plus 5% growth that one is seeing here is probably a slight underrepresentation of the true growth, and this is due to late last year shipment to our partner in Japan to deliver the product with the existing labels before our indication approval for psoriasis and PsA. So that's about EUR 10 million, which otherwise would have showed up here. In Europe, the slow growth is not a surprise. We actually had some price erosion, which compensated for volume growth. And of course, with COVID-19 hitting certain markets hard, we've had a little slowdown, but we are confident that in Europe, hospitals and physician systems are now organized to treat patients and to see the new patients that perhaps haven't had the opportunity for treatment initiation or switches. So let me perhaps say a word about the indications. And of course, you saw that psoriasis is a -- it starts becoming an important growth contributor for Cimzia. But across the world, the women of childbearing age segment has continued to grow as medical guidelines continue to back up the utility of Cimzia and a more modern way to envisage the care of women of childbearing age with autoimmune disorders. And this is also supporting the continued growth of Cimzia in rheumatoid arthritis, for example. So finally, a quick word on Evenity. So you remember that about only 20% of patients with an osteoporotic fracture received any type of treatment post fracture. Now fractures in postmenopausal women are 5x more likely -- so those women are 5x more likely to suffer a fracture within a year after a first break. And these can be life-altering events. So our efforts, together with our partners, Amgen, are as much about leading in and expanding the bone-forming market segment as about supporting enhanced care for patients with severe osteoporosis who have suffered a recent osteoporotic fracture. UCB is invested in making this happen at a global scale with our partners, together with the International Osteoporosis Foundation, Oxford University. And this is through a program which is called Capture the Fracture partnership. And together, we aim for a 25% reduction in hip and vertebral fractures by 2025. And so this partnership is up and running and working well with many centers adopting its recommendations. In 2020, our focus in Europe is on gaining access with Evenity, and we're very pleased with the recognition of value that has come about with the German health technology assessment, IQWiG, which has indicated considerable added benefit for Evenity in this specific population. So this now needs to be translated with a G-BA reimbursement approval in the months to come. In addition, we've had Sweden become the first country in Europe to approve reimbursement for Evenity, again, recognizing the value that this asset can bring to society. In addition, we've received approval for Evenity for Swissmedic in the first week of July. So we are pleased to see that the picture in Europe is completing. Of course, it's been a virtual launch largely since this was first introduced in March. We've been leveraging remote education and interactions, and teams have now reinitiated in-person visits, and the response to Evenity is very positive in Germany. There's a good understanding of the label. And so we are bullish about the prospects of Evenity in Europe. Again, Amgen will comment on the U.S. and Japan tomorrow. So in conclusion, for the first half in immunology, I would say, first of all, strong fundamentals for Cimzia growth towards our EUR 2 billion peak sales target over the years to come. Positive signs for Evenity in Europe. We've achieved our target product profile for bimekizumab, which has triggered actions in the area of supply and, of course, market and launch readiness decisions. And our pipeline of immunology programs have been moving forward with the inclusion of several potential first-in-class and best-in-class solutions. And with this, it's my pleasure to hand over to Charl.

Thank you, Emmanuel, and good morning, good afternoon to everyone, and I would like to just start by making a quick couple of opening remarks. First of all, despite the challenges that the industry has faced, we have acted very fast. And I'm obviously very pleased and proud of our teams that we've been able to deliver a very strong and resilient performance in the first half of this year with our underlying performance of our epilepsy brands. You will also see through the presentation that we have significantly diversified our pipeline, of course, in urology with a very strong potential for growth in the space of neuroinflammation. So I would characterize our first half performance really as a resilient performance and one that we feel very confident about as we go forward for the remainder of the year. So as you see in the slide, we are firmly in our Accelerate & Expand phase. And on the left-hand side, you see our 4 key epilepsy assets that have consistently delivered. What is important to know here that these are trusted brands in epilepsy that serve a very broad number of needs for patients from pediatric patients to older patients to patients with comorbidity or patients that require treatment for seizure clusters like in the case of Nayzilam. So therefore, based on those trusted brands and the consistent performance we see across a number of geographies, we feel very confident that we are able to continue that performance through the remainder of the year. If we could just go back to the previous slide, I just want to make some quick comments on our diversified pipeline. As you would have heard from my colleagues and also from Jean-Christophe, our acquisitions, of course, have been very important to fortify the epilepsy pipeline in the midterm and, of course, accelerate our emphasis into neuro inflammation, into rare diseases with the acquisition of zilucoplan. So with those elements and the combined focus on the Phase III programs, we feel we have a very strong position beyond the LOE of Vimpat to continue building on top of epilepsy, a very strong expansion into neuroinflammation as well. If we then go to the next slide, just to go a little deeper into the performance. As I mentioned, it's a very resilient performance across a number of geographies and across all the assets. Notably, Vimpat at 16% and Briviact at 40%. Of course, this year also launching Nayzilam into seizure clusters has been an important addition for high unmet need area in the U.S. And we see a constant stable performance of Keppra in the background to continue to support this growth. On the right-hand side of the slide, you see our constant focus on expanding the label we have of our key assets, Vimpat and Briviact. And of course, with Nayzilam now we have a very strong offering there, as I mentioned, for addressing an area where there is no treatment today, which is seizure clusters. Now if we go a bit further, I want to make some comments on the next slide to our -- as I mentioned, we've fortified our epilepsy pipeline through the acquisition of Staccato Alprazolam. In this case, we're really addressing a much larger patient population. Most patients are well controlled, but they do have breakthrough seizures, which often lead to an emergency event or potentially hospitalization. With Staccato, we have in our hands now a rapid profile of a molecule that is rapid acting, essentially 30 seconds to 2 minutes, so a rapid-acting short duration and in a very convenient delivery device that really puts control back in the hands of the patients and caregivers. So we see this as an important solution for the future, really a paradigm shift in treatment, where we can move to more on-demand treatment and really put control back in the hands of the patient, so they can live the life they would like to live. So with this, we will continue, as Iris had mentioned, into a Phase III program in the second half of '21. If we then go to the next slide, I really want to conclude here with just a couple of quick comments, again, to emphasize how important we see the future for epilepsy, that we have a comprehensive portfolio, as I mentioned, that continues to serve a wide range of needs for patients. But we're also thinking longer term in investing in digital solutions for patients so that there is more seamless interaction between patients and health care professionals, in a sense, a greater patient experience, leading to better disease management and better outcomes for patients. So this is an area we will continue as leaders to develop further. And of course, through our science and our better understanding of the innovation, we also aim to address very specific solutions for disease modification. So when you look at epilepsy, our ambition remains unwavered to continue to lead in this space in the long term. And building on top of this foundation, as we've mentioned, an opportunity now to continue to expand in the space of neuroinflammation with our 2 very strong assets in zilucoplan and rozimab to find new vectors of growth, of course, for UCB in neurology. So with that, it's my pleasure to hand over to Sandrine and also to give Sandrine a warm welcome to the UCB team. Thank you, Sandrine.

Thank you. Good afternoon and -- I'll start again. It was the mic. Maybe it's better. So good -- thank you, Charl. Good morning. Good afternoon. It's my pleasure for this first meeting with you to present you these good financials. And I'm joining a company which is in good states, which has shown over the past years, sustainable growth, both top and bottom line growth. And the first half results, performance continue in line with this past trend. We have a solid foundation in place to accelerate growth in the coming years. So you see on the right part of the chart that this growth was driven by the continued positive and resilient performance of our UCB's product portfolio. And I think it's important to highlight that there has been no disruption in the supply chain or the production, and the company was able to maintain for patients the availability and access to their medicine. Now looking at the financials on the next slide, just starting with the net sales. The double-digit growth of net sales in the first half was driven by the resilient UCB product portfolio, as I've just mentioned, with 2 medicines, which were added in December 2019, the launch of Nayzilam; and starting in March 2020, Evenity was the first European launch. Marketing and selling expenses increase was driven by launches and prelaunch activities. Cimzia in non-radiographic axSpA in the U.S. and the launches in China and Japan. Nayzilam not -- launched in December in the U.S. and Evenity launched in Europe in March. But as well, launch preparation expenses for bimekizumab for the treatment of psoriasis. Looking at R&D expenses. They include, for the first time, the R&D expenses for the Ra Pharma development program, but as well the termination costs for a total amount of EUR 38 million of the project padsevonil, but it also includes high investments in the UCB progressing pipeline with 5 late-stage assets. So all in all, we ended up with an EBITDA -- adjusted EBITDA and revenue ratio of 30%. And by the way, you will have noted that we have changed the terminology of our performance metric into adjusted EBITDA. It's following the guidelines of ESMA, the European Security and Market Authorities (sic) [ European Securities and Markets Authority ]. And it is simply a change in terminology, it's not a change of methodology. Tax rate is at 15%, in line with guidance. And our profit evolution reflects the onetime expense of M&A activity with Ra Pharma and Engage Therapeutics activities. So all in all, core EPS is at EUR 2.77. Now looking at the next slide on evolution of cash flow and debt. You can see that cash flow from continuing operations was solid and grew versus last year with nice trends over the past years. And on the right part of the chart, you can see that the Ra Pharma acquisition increased the level of our net debt, which was at EUR 1.9 billion at the end of June. And the net debt to adjusted EBITDA ratio is at a healthy level of 1.3x. Now regarding our guidance, moving to the next slide, we confirm our 2020 outlook. Of course, we will continue to closely follow the evolving COVID-19 pandemic to assess the potential near and midterm challenges. But based on our current assessments, we remain confident in the fundamental underlying demand for our products and the prospects for the long-term growth. We confirm 2020 financial targets, and we confirm the midterm guidance for 2022, with a 31% adjusted EBITDA revenue ratio. We confirm as well the peak sales for Cimzia, Vimpat, Briviact and Neupro. And with this, let me hand over back to Jean-Christophe for concluding our presentations and ahead of opening the floor to questions.

Thank you. Thank you very much, Sandrine. My last slide before really the closing is just a reminder of where we are in the deliverables of what we committed to deliver with you for 2020. And as you can see, we are very pleased with where we stand after the first half of the year with a lot of achievements that already have been done after the first 6 months. The Phase III start in lupus for dapirolizumab will be in the near -- very near future. And then we're also very waiting for the filing acceptance of bimekizumab in psoriasis at the end of Q3. So you see a lot of things that have -- already have been achieved and we are in a good -- very confident to deliver on the 2 other elements for the rest of the year. So allow me to close with maybe a slide, which is quite unusual in a financial presentation. But considering what we have been through as an industry, as a team, as people, for all of us in the last 6 months, I would really like to give a big thank you to all of our colleagues at UCB. There have been a lot of challenges, but there have also a lot of amazing accomplishments during the first 6 months of the year, changing habits, working from home in a completely remote way, continue to ensure patients' delivery, transforming part of our manufacturing sites into diagnostic sites, being able to do much more and beyond what was the -- what was demanding, but trying to go to the extra mile. And you can see all of these faces have done that with a big smile. So I really would like to thank them. We had a hashtag, which was #strongertogether during the pandemic. We're transforming, that is stronger than ever now that we are moving into the next phase. But I think that none of the results that you have seen with my colleagues previously would have been able to be there without the individual and collective engagements of all of our colleagues at UCB. So with that, I would like to close the presentations and hand over to Antje for the Q&A session. Thank you.

Thank you very much. Thank you for sending in your questions, and we have quite a long list already. If I may start with Wimal Kapadia from Bernstein. That's going to Emmanuel, I would say. How do UCB see -- how does UCB see the potential for bimekizumab across the 3 indications? Clearly, psoriasis is ahead, but PsA and axSpA will also be key. How does management view the potential of the joint indications longer term? And what indications do you expect to see greater sales contribution?

Thank you. Thank you for this very good and relevant question. So perhaps, first, we should think about prevalence and about the size of these opportunities. So a simple way to think about it is that psoriatic arthritis, axial spondyloarthritis and hidradenitis, taken together, might near in terms of patient numbers and market size the opportunity in psoriasis long term. However, there's less choices in hidradenitis in axSpA and to an extent in psoriatic arthritis than psoriasis. So we will enter into a market that will be less competitive than the psoriasis market today. But like psoriasis, the results we've shown so far in our Phase IIb studies as well as in our HS proof-of-concept study are results where bimekizumab provides a particularly deep response to a relatively high number of patients. And so we really have a best-in-disease opportunity in those 3 indications where the relevance of IL-17A and IL-17F cytokine is suggested. So I think it's a little early to start talking about forecasts and size of indications. But clearly, with those 3 indications being less competitive and together nearing the size of the psoriasis market, I would venture to say that taken together, there's a chance there that provided our Phase III results confirm our Phase II and proof-of-concept results that bimekizumab could derive a significant portion of its sales in those 3 new indications.

Thank you very much. The next question is from Jean-Jacques Le Fur from Bryan Garnier, and it's going to Charl. Now Ra Pharma is fully integrated, how do you view the future for rozanolixizumab?

Thank you for that question. And first of all, the way we look at specifically the treatment, in this case, for myasthenia gravis is that you need multiple mode of action to be able to fully treat the condition. And having a C5 complement inhibitor, in this case, zilucoplan, as well as an anti-FcRn in the case of rozimab, make perfect sense to treat different stages of the level of control of the patients. So we see zilucoplan and the C5 inhibitor as being important to maintain a certain control and a convenient daily dosing, whereas we see anti-FcRns playing an important role, in this case, rozimab, in really treating the acute phase and therefore, avoiding the invasive situation with IVIG in the hospital setting by taking that to the home setting for the patient. So we see both coexist very strongly. And of course, our development programs are very much mirroring our ambition to develop both in the space and also potentially in other patient populations as we go forward.

Thank you very much. Jean-Christophe, Peter Verdult from Citi is asking you, can you share your thoughts on the various U.S. drug price proposals being made? Reference pricing could be particularly bad for your immunology franchise. So I'm interested to see what you perceive to be the feasible reform and worst-case scenario.

Thank you, Peter, for this good but very difficult question. So as you know, last Friday, we had this publication of these 4 executive orders around drug pricing in the U.S. It was made Friday evening U.S. time. The one that you referred to, which is the international price index and the reference to what it's been named the most favored nation was signed last Friday, but the administration have not yet released the text. So we are a little bit in the interim situation. Let's put it that way. There has been a delay that has been mentioned until August 24, to try to see how this could be implemented with the request for partners to jump in and potentially to make some additional recommendation there, and as well as CMS. And Seema Verma indicated the Medicare Part B would be implemented and would be impacted by this. So it has been months that we knew that something around these elements would be there. Now there are 2 elements that I would like to share with you. First one, it's about the clarity of the content. These executive orders have been released for some of them with very high-level mention, but it's not yet clear how that will be implemented. So we are still in the process of better understanding how it will work. And the second element is really the timing. We are already, end of July, beginning of August with elections coming in, in November. It's not really clear how much time the administration will have to put these executive orders in action. However, we know that these questions of drug pricing across the different geographies is on the table and likely will stay. What I can say is that for our part as well as for all of -- most of our colleagues, what we want as a pharmaceutical industry focusing on innovation, we want a few things. One, we want to be part of the solution. So we want to be associated in all the different discussions to try to see how we can make innovations affordable for the patient; two, we want to make sure that there is a recognition of the value which is created; and three, we want to make sure that all of that allow the patients to have access for the long term. So I think that as long as we can engage the different stakeholders into these conversations. As long as we can participate to this conversation, I think -- and as long as innovations will be recognized, I think, we'll always be there to try to make sure that the future can give a place for innovations in the best possible way.

And if I may, I continue, Jean-Christophe. The full year guidance is left unchanged, implies a kind of a step down during the second half. Could you please a little bit elaborate on the guidance kept -- being kept unchanged?

Yes, sure. We think that it's more reasonable at the current period to maintain the guidance as it is. It's not really a moment where we can try to evaluate the first half and then multiply by 2 and then evaluate what will be the second half of the year. I think that there is a lot of complexity also in the first half. We have been a little bit of a stocking effect at the beginning of the second quarter. We have some destocking effect in the end, when the economy was reopened in the European market, for example, and as well as the U.S. So we are very pleased with the strong demand, and so that's the reason why I think what you see as a performance for the first half of the year is supporting by this demand. However, we don't know exactly what the second half of the year will reserve and will unfold in terms of resurgence of cases. And so we think that during this period of time, it's more appropriate to suppose and to confirm the guidance versus doing other commitment.

And then Peter continues on Evenity, and he's also asking you to answer this, but you might decide otherwise. He says he's looking at this nice ramping of Evenity. And doctors he's speaking to are comfortable returning to Evenity in an in-patient -- in a patient that has previously received a 12 months treatment. So he wants to know a little bit about our peak sales expectations for Evenity and how big the opportunity could be.

Well, I can get started and Emmanuel, please feel free to add because I'm very happy to answer these questions, Peter, but not sure that you will be happy with my answer but -- because we will not comment on peak sales. But what I'm happy with is that you mentioned that physicians -- because it's the same message that we got that physicians are very comfortable in prescribing Evenity and are very pleased with the results. If you remember, this has always have been our stand. We always have been very impressed by the ability of Evenity to deliver strong results. It's also unprecedented. If you look at the speed by which we are able with these products to rebuild bone for osteoporotic patients. And Emmanuel mentioned that when we have a fracture already, you have 5 times more risk to get a second fracture within 12 months, meaning that it's very important, first, to be treated and secondly, to be treated with an efficient drug. So we always knew that we have a very solid drug in our portfolio which can deliver unique value for patients populations. So we are happy to see that the patients and the physicians recognize that. I think that time will tell how we can continue to evolve and develop the life cycle in terms of redosing. But so far, the first insight that we get are very positive. There is no reasons, in a sense, to not to explore further what you have mentioned, which is when will be the best time to redose. So we are looking at that right now. But from a timing perspective -- but from a content perspective, we are very pleased. Emmanuel, I don't know if you want to add something, too?