Home / Transcripts / UCB SA (UCB) · February 25, 2021

UCB SA (UCB) Earnings Call Transcript

February 25, 2021

Euronext Brussels BE Health Care Pharmaceuticals earnings 84 min

Earnings Call Speaker Segments

Operator operator
#1

Ladies and gentlemen, welcome to today's investor call [indiscernible] on Full Year 2020 Financial Results Conference call and webcast. [Operator Instructions] Please note that this conference call will be recorded and that a replay of the video webcast will be available later today. I am now 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.

Antje Witte executive
#2

Thank you very much. Hello. Hope you're doing well, safe and sound. Good day to you. Welcome to this call. On the next slide, you will find our disclaimer and safe harbor statement under which this call and the following Q&A session, as usual, is to be seen, and we kindly request that you read this carefully. On the next slide, you find the panel of today's presentation. And very soon, I will hand over to Jean-Christophe Tellier, our CEO. We then have Emmanuel Caeymaex, our Vice President -- Executive Vice President, sorry, for Immunology Solutions, who will talk to you about Cimzia, Evenity and of course, bimekizumab. We have our Chief Medical Officer, Iris Löw-Friedrich, to introduce your 2 myasthenia gravis treatment options and give you the pipeline update. Followed by our CFO, Sandrine Dufour, who will give you the solid foundation, enabling our future growth. And we will finish with Jean-Christophe to give you the insights where we want to be in 2025. Thank you so much. Jean-Christophe, the floor is yours.

Jean-Christophe Tellier executive
#3

Thank you very much, Antje. Good morning and good afternoon, everyone. I hope you are all well. And a warm welcome from my side also to our 2020 full year results. 2020 has been by many ways, an exceptional year and a year which tested resilience, agility and efficiency of teams and organization. And in this context, I'm particularly happy to report strong results for UCB. As you can see in this slide, we delivered a seventh year in a row of growth as our revenue moved up 19% to reach EUR 5.3 billion. Our underlying profitability remained at EUR 1.4 billion, which is a testimony on our ability to continue to invest in our pipeline and also to invest in our future launch product. Future products, which is illustrated here by bimekizumab, which has been filed with the FDA and EMA for psoriasis in time has -- we have no delay from the pandemic. And with this very solid and strong results from 2020. As you have seen, we are happy to share with you our outlook for 2021. Where we will be able to deliver revenue between EUR 5.45 billion and EUR 5.65 billion and an adjusted EBITDA from 27% and 28%. But we didn't want to stop there, and we wanted also to give you the confidence that we have and share with you the confidence that we have in our future by sharing with you for the first time, our outlook for 2025 and where we aim to be. And for 2025, we will be pleased to get at least EUR 6 billion of revenue and improve our profit to low to mid-30s. If I can have the next slide, please. So as I said in introduction, 2020 was a very particular year you can argue that the pandemic was an accelerator for a lot of emerging trends, which was already there before and not just a disruption. You see here 4 of them, which I think are maybe important to keep in mind. First, the pandemic has created a tremendous acceleration of digital transformation. Things that we thought was not possible before suddenly became a habit within days. It's also create even more uncertainty and volatility in our environment from an access, pricing and demand management. But it's also -- and you see that on the left side of the slide, you can see also that, for me, it's critical and it was a critical demonstration of the value of innovation. And it was also a revelation of how important the sustainability and the societal impact is for our business. Next slide. And with this in mind, I think that for us, like for everybody, it's even more important to be more connected to our sense of purpose. It is very clear that, for us, creating more value for patients, meaning more differentiated clinical outcome, best experience and access for the patient's who need them, will even more ensure our success in the long term. And so focusing on these elements were even more important in 2020. But focusing on purpose, it's also an objective and a way to stimulate everyone, energy and engagements to what they are doing and contributing to our common goal and objectives. It's an opportunity for each of us to be even more at our best. So gaining efficiency through focus and being even more at our best by managing our sense driven leadership was maybe 2 elements that I would like to take away also from 2020. Next slide, please. And the final element, which I take away from 2020 is the necessity for all of us to integrate even more sustainability in our business approach. Because we cannot create value for patients if it is not connected for value for society. And the 4 pillars of our sustainability engagement, focus on innovation, access, well-being of our people and health for the planet are fully integrated into everything we do in our patient value strategy. Next slide, please. And so all of that help us to continue to deliver on our strategic growth path in 2020. And you have seen this slide before, is a slide that we are presenting to you every year, our strategic growth path. We are now in the Accelerate and Expand phase, and you have seen what we have been able to deliver so far on this accelerated growth phase. 2020 in this context was a very important year as a year, where we were able to demonstrate our ability to care, to grow and to deliver. To care first, caring for our people, caring for our patients, ensuring continuity of care for them, caring for our communities, but also caring for science and making sure that we contribute to the science in this period of COVID-19 was an important element to remind us how valuable our industry is for society. Growth, because we were able to grow in that context for the 7-year in a row and this was based on the solid performance of our core drivers. And deliver, because we continue to deliver on the pipeline, delivering the third Phase III clinical trials on bimekizumab plus the Phase IIIb against treatment of psoriasis was an illustration of this positive evolution of the pipeline. But deliver also on our strategic agenda with acquisitions of Ra Pharma of Engage Therapeutics, the partnership with Ferring, the acquisitions of Handl Therapeutics, the partnership with Lacerta, all of these elements demonstrates our continued focus to make sure that we are delivering on our strategic agenda. And now I would invite you to go a little bit deeper in these elements, and I would like to hand over to Emmanuel.

Emmanuel Caeymaex executive
#4

Thank you very much, Jean-Christophe. And greetings, everyone. Over the next few minutes, I will briefly touch on how our immunology business is strengthening by touching on Cimzia's continued growth, on Evenity with the first full year of results as well as bimekizumab and our launch readiness as well as the progress in the clinical field. So starting with Cimzia, you can see that we achieved to grow our sales to EUR 1.8 billion in 2020. That is a 7% growth at constant rates. The -- all the regions contributed to the volume growth. The U.S. was the main driver for value growth. And it is note worthy that in 2020, our at-home prefilled syringe formulation growth exceeded that of the in-office lyophilized formulation. The prefilled syringe business in the U.S. represents 37% of our worldwide sales, whereas the lyophilized formulation accounts for 28% of worldwide Cimzia sales in 2020. Now the asset has grown particularly in fields where we have had recent label expansions or indications. And as you can see on the left panel of the slide here, psoriasis was an important growth contributor as well as the two spondyloarthritis. Looking forward to 2021, I would say that with a strong exit in 2020, with those growth drivers being intact, I would see continued strong volume growth and also anticipate further price pressure as a result of the availability of biosimilars, but also government induced pricing measures that are likely to take place. I'm very proud about the agility that our teams have shown in 2020 in engaging in a meaningful way with our customers. And I believe that, that is one of the reasons why Cimzia has continued to grow. Now if we think about the TNF market, Cimzia has actually exceeded the growth of the TNF market very significantly in the U.S. and significantly in Japan and has been able to continue to grow in Europe, even though the market has grown a little faster. So if we now move to Evenity. Evenity has reached more than 100,000 people since it was first approved about 1.5 years ago. 2020 was the first full year of launch. And in the context of the pandemic, which obviously impacts on the ability for the target demographic to physicians in the clinic as well as our and our partners' ability to detail those physicians, it has been a very good result. And in fact, we have achieved breakeven with Evenity in 2020. Evenity is now a net contributor. The asset is very well differentiated, as you can see on the left panel, and it is very well positioned now as the treatment to grow bone after a fracture in a person, women mostly with severe osteoporosis. So based on that and based on the fact that the asset has achieved more than $400 million in-market sales across our partnership with Amgen and their partner, Astellas, we can look forward to the future with a lot of optimism. Europe contributed $2 million in that $400 million, arguably still small, but the feedback of payers has been very positive. And I would say also that the market share uptake in Germany is actually tracking the uptick we have had in the U.S. And so I believe that the main area of focus will need to be to actually grow these markets, and that is why we have captured the fracture partnership with Oxford University, the IOF as well Amgen, and our aim is to reduce the incidence of osteoporosis related hip and vertebral fractures by 25% by 2025. So in summary, the outlook is very promising for Evenity. When the pandemic restrictions will lift, I am sure that this will translate into reacceleration and this will also be a good time to start focusing on addressing the silent epidemic, which osteoporosis and osteoporotic fractures are. Next, we'll move to bimekizumab. We've been very pleased in 2020 to be able to share the Phase III results of bimekizumab in psoriasis. We know that patients prefer achieving completely clear skin and that it is very important for that result to be maintained over time. And as we've said it out in the last few years, we believe that the IL-17A and IL-17F inhibition is a mechanism with an elegant antibody that enables us to achieve truly unique outcomes. That is true for speed with a single dose achieving what is commonly regarded as a TNF efficacy, more than 75% of patients achieving PASI 75. The depth of response is very impressive with 6 out of 10 patients achieving PASI 100, completely clear skin at week 16, which is the typical duration for a primary endpoint. And then very importantly, the ability to maintain this. And on an intention to treat population, you can see or you have seen for example, in the BE SURE study, that 70% of patients achieved completely clear skin, so essentially expanding the number of people that benefit from that unique outcome between week 16 and week 56. Now what is remarkable is that, that has been achieved at an every 4-week dose, but it also seems that the every 8-week dose is achieving similarly impressive results and that is very intriguing, not only as a differentiator in the IL-17 category, but also from a model action point. Now PASI 100 at week 16 and at 1 year are also the primary and the key secondary endpoints in the superiority head-to-head study, which we will report the results about with psoriatic as an active comparator. So this is hopefully going to be shared end of April at the American Academy of Dermatology. Now if we move beyond psoriasis on the next slide, you know that we have 3 Phase III programs in different indications. It is important to explore those indications because many patients suffer from progression from one disease to another, most well-known from psoriasis to psoriatic arthritis, but also because of the considerable overlap between those conditions. For example, there seems to be a 10% overlap between HS and axial spondyloarthritis. The Phase IIb data in PsA and in axial spondyloarthritis with bimekizumab were very impressive and have been published. And our proof-of-concept results including HUMIRA as an active comparator in a get equally shows that bimekizumab has the potential to bring unique outcomes and a unique depth of response for HS patients. The PsA and the axial spondyloarthritis Phase III results will start yielding results at the end of this year as per plan. And so we are looking forward to updating you in due time towards the end of the year. So if we move to the next slide, a few data points here to share, be awareness and the high anticipation that exists for bimekizumab with dermatologists. With the scientific meetings and the publications, it has really become an asset that health care professionals are waiting for, and we were pleased to see that their understanding of the relevance of the dual inhibition of IL-17A and IL-17F. Our launch readiness is progressing very well. We have fully staffed our teams in sales, marketing, medical affairs and access in Europe and in the U.S. And of course, with Cimzia, we have an opportunity to practice. And the discussions with the regulators, the payers and reactive scientific engagements are going on with the high intensity. So we are very much looking forward to bring bimekizumab to patients with psoriasis, a transformational experience. And with this, we will have 3 growth drivers in our portfolio. And with this, I would like to hand over to Iris.

Iris Löw-Friedrich executive
#5

Thank you very much, Emmanuel. And a very warm welcome to all of you. I will take you on a deep dive into generalized myasthenia gravis, GMG. As you all know, this is an autoimmune disorder that occurs in about 10 out of 100,000 people, and we all know that estimates vary quite widely. GMG can strike any person, any age, any social and ethnic background. It's clinically characterized by severe weakness in several muscle groups. Accordingly, there's typical symptoms, grouping eyelids, double vision, difficulties to speak and swallow, to raise to stand, to walk stairs or to exert firm grips. This means that patients quality of life is quite severely impacted, starting with the inability to perform activities of daily living. Like, for example, combing, preparing chewing solid food, participating in a conversation. For many patients, it becomes almost impossible to concentrate and to fulfill the demands of a drop. For some patients even breathing can be difficult. The underlying biology of gMG is well understood. It is a efficient transmission of nerve impulses to muscles. The normal communication between the nerves and the muscles they control is interrupted at their natural interface, which we call the neuromuscular junction. In health, the nerves release a transmitter acetylcholine that binds to its receptor on the muscle, thereby acetylcholine activates the muscle and causes the contracture. In gMG, autoantibodies block signal transmission and alter or destroy the micro architecture of the neuromuscular junction. This then prevents the muscle from contracting and causes the nerve weakness. Autoantibodies against the acetylcholine receptor, I will abbreviate this as AChR going forward are the most frequent source of damage and they occur in about 80% of the gMG patients. However, other auto antibodies like those against muscle specific kinase, MuSK, also have harmful effects and they occur in about 10% of patients. AChR autoantibodies are mainly of IgG1 and IgG3 isotype, and there are 3 different ways to attack. They can directly block individual acetylcholine receptors, they can lead to receptor internalization as they activate the complement cascade. Activation of the complement cascade leads to the formation of the membrane attack complex, which destroys the postsynaptic membrane of the neuromuscular junction and thereby impacts muscle function. Mass antibodies act similarly, but due to their IgG4 isotype, they do not affect the complement cascade. Next slide, please. In consequence, there are 2 potent and complementary novel ways to treat gMG. One pathway is the enhanced degradation of all auto antibodies via blockage of the neonatal Fc receptor, which leads to the reduction of AChR and MuSK antibodies. This is, of course, the mechanism of rozanolixizumab. The other approach, which is very specific for AChR autoantibody mediated gMG is through complement inhibition. This is the mechanism of zilucoplan which blocks the terminal complement pathway very effectively. In UCB, we are very mindful that each patient is different and that each person living with gMG will need different medicines at different times in their lives. In the spirit of tailoring treatments to the disease biology for each individual patient, we have identified an emerging treatment algorithm for gMG, which look like this. Initially, treatments are allocated based on a patient's dominant autoantibody. For the 80% of patients with AChR autoantibodies, treatment with a complement C5 inhibitor, zilucoplan, might address the root cause of their disease in the most effective way. And this is where we see the place for zilucoplan in future treatment regimens. We aspire an efficacious and safe treatment for patients with AChR autoantibody positive gMG. Zilucoplan in these patients would offer a maintenance therapy that will allow high-quality of life, stable symptom control and ideally also reduction of immunosuppressants and corticosteroids. Zilucoplan is easy to administer with a quick, well tolerated daily subcutaneous injection. It's truly suitable for lifetime therapy, we imagine. We believe that patients with moderate-to-severe disease should be able to access zilucoplan regardless of disease duration or treatment history. We are very conscious that zilucoplan might not work for each patient. There are 3 distinct patient groups who will need the elimination of their autoantibodies and therefore, treatment with an FcRn blocker, rozimab. First, these are the people with MuSK antibodies, still 10% of the gMG population who due to their pathogenic autoantibody will not benefit at all 4-complement inhibition. Then there are also the AChR antibody positive patients who may not respond to zilucoplan. And then there are those patients who experience an exacerbation of their disease, while being treated with zilucoplan. For these 3 very distinct patient groups, the treatment with an FcRn inhibitor, rozimab is an obvious solution. This is our vision for the future of gMG treatment. And it's very much in line with our commitment to develop individualized treatment approaches, connecting truly our scientific understanding with the patient. Our confirmatory studies with zilucoplan and rozimab are designed to address these options. The RAISE study, that is the confirmatory study with zilucoplan, is recruiting patients with moderate-to-severe gMG, who are AChR antibody positive. And these are patients who are recruited irrespective of their prior treatment. The study is placebo-controlled and offers daily treatment over 12 weeks, followed by an open-label extension study. In contrast, the Phase III study with rozimab is recruiting patients with moderate-to-severe gMG, those who are AChR antibody or MuSK antibody positive, those who are treatment-refractory and who are considered for IVIG or plasmapheresis treatment. The study is also placebo-controlled versus 2 different doses of rozimab. And of course, the study has a short treatment duration, 6 weeks and is followed by an open-label extension study that supports further treatment cycles as necessary. Of course, our results and our regulatory submissions and approvals are still to come. But I'd wanted to share our vision with you. We expect the RAISE study with zilucoplan to read out in the end of this year, and we expect the Phase III study with rozimab to read out in first quarter next year. And if I could please have the next slide. This is our pipeline chart, and you are very familiar with it. I will stay for a moment on rozimab, you have heard about our commitment to rozimab. It stands firm. The mechanism of action is largely derisked. And we have Phase III programs in gMG and in immune thrombocytopenia underway. We also continue to focus our resources on those new patient populations where autoantibodies are clearly the underlying disease biology and where there is high unmet need. Following this paradigm, we are preparing the start of 2 additional clinical programs already in 2021 in new patient populations. Please stay tuned. In contrast, people living with CIDP, chronic inflammatory demyelinating polyneuropathy are heterogeneous patient population with very few [indiscernible] with only 30% of detectable autoantibodies. This is well researched, well understood, and you will find publications there, for example, in nature. While it's understood that the disease biology is complex, again, we are lacking the research to really identify the underlying route causes for CIDP. So while our Phase IIa study in CIDP patients supports the conduct of a confirmatory clinical study, we decided to prioritize those conditions that are solely autoantibody mediated in underserved populations over CIDP. So now let's really take a quick look at the clinical stage pipeline in its entirety. We have commented on most of our assets already, and I'll not go into any further details. However, I'm really pleased that I can confirm the timelines for all of our ongoing programs, which we shared with you last summer. These timelines stand solid and are still valid despite the still very palpable impact of the pandemic. Pandemic is really omnipresent and unpredictable. And I'm deeply grateful, and we owe this performance to the resilience of our patients, our investigator site and of our clinical teams and also to our stringent digitalization. So again, we will deliver as we have promised last summer. And with this, I'm pleased to hand over to Sandrine Dufour, our CFO. Over to you, Sandrine.

Sandrine Dufour executive
#6

Thank you, Iris. Good morning, everyone. It's my pleasure to present solid performance for our 2020 financials. Our results reflect the continued growth of our product portfolio, investments to support the rich development pipeline that Iris has just presented and the preparation for launches. And these 3 factors will enable our future growth. So what you see on this slide is how to position these 2020 financial results in a long-term trajectory. We can highlight a solid growth, both top line and bottom line, with 8% of revenue CAGR for the revenue over the last 7 years and a faster double-digit EBITDA growth of 16%. So very solid foundation. And on this trajectory, 2020 is the second year of the Accelerate & Expand phase. And in the challenging context of the pandemic, it has shown a very resilient growth and profitability level. So moving to the next slide. What we show here is where the 7% constant rate net sales growth originates, driven by the continued positive and resilient performance of the product portfolio. So what you see on the left side is by therapeutic areas and on the right side by product. So Emmanuel has already commented on Cimzia and Evenity. So let me share some highlights on our epilepsy portfolio. It represents more than half of our net sales. As you can see on the left side of the chart, the total net sales in epilepsy grew by 12% at constant rate. We now have 3 million patients using UCB epilepsy treatment and UCB is ranked #1 on the global epilepsy market with a market share of 20%. And I would like to highlight the 12% growth at concentrate for the impact, which is quite remarkable at this stage of the life cycle of the product. And also another element to highlight is that since October last year, in Japan, UCB has been distributing directly E Keppra while before it was co-promoted with our local partner, Otsuka. And this is having a positive effect on sales in Japan for Keppra. And the last comment in the epilepsy portfolio, you can see as well that Nayzilam was successfully launched and has reached a EUR 26 million net sales in 2020. So all in all, a solid growth of our core products. Next slide. We're moving to the financials, and let me take you through our P&L and how our revenues are flowing down to the earnings. So revenue growth is largely driven by the net sales progression that we've just seen. And on the OpEx at this stage of our strategy, the OpEx are growing faster than the revenues as we are supporting launches, the prelaunches and the R&D pipeline. So assuming on marketing and selling expenses, they increased by 10%, and this was driven by the launches in the prelaunch activity. So Cimzia in non-radiographic, axial spondyloarthritis in the U.S., launches in China, launches in Japan. For Nayzilam, it was launched in December '19 in the U.S. And Evenity was launched in Europe in March. As well you have, as Emmanuel commented, the launch preparations for bimekizumab for the treatment of psoriasis. Also to note in the context of the pandemic, we have accelerated our digital transformation in the way we interact remotely with physicians in our targeted marketing approach, in our data and analytics capabilities, in our CRM tool. So all this explains as well a part of the increase. Now if I move to R&D expenses, they represent 29% of our revenues and they have grown by 23%, and that includes the impact of our new acquisition. So the R&D development program for Ra Pharma, Engage Therapeutics and Handl Therapeutics. They also reflect the investment in the progress of our pipeline with 5 late-stage assets. Also digital transformation, I wish to mention that, investment as well. And lastly, it includes the termination cost of the projects at padsevonil. And in the first half, remember, we had slightly lower R&D expense growth due to the recruitment cost. In the second half of 2020, we were able to progress on the recruitment of patients. We had new R&D programs, and we also put in place some measures for the patient safety, which were linked to the COVID-19 context. So all in all, we end up with an adjusted EBITDA margin ratio of 27% at the top end of our guidance. It includes, as Emmanuel said, for the first time, the contribution of Evenity, as you know, it's only consolidated for the European sales on the top line, so EUR 2 million, but it supports our costs, it supports what we recharge to our partner and also the part of the profit we get from our partners. So the whole contribution has turned positive for the first time in 2020. Now if I move to the profit, here the evolution reflects the one-off expense of the M&A activity with Ra Pharma and Engage Therapeutics acquisition, but it also reflects a 13% tax rate in 2020. And our core EPS is at EUR 5.36 per share. And here, it reflects the lower tax rate, but also below of financial expenses. And for that, on the one side, we had lower hedging costs, and we repaid a bond in March 2020. And on the other hand, we had the interest expenses due to the debt financing of the Ra Pharma acquisition. So all in all, solid results, profitability, which reflects the higher investments we are making into the future growth of UCB. Now If we move to the next slide. I would like to share with you how we articulate our capital allocation. Supporting our strategic priorities, ensuring a sustainable return to our shareholders and maintaining a strong and flexible balance sheet. So starting with the capital we allocate to our strategic priorities. First, as you know, we are investing in innovation for patients with a high level of R&D expenses. Second, we are also funding some growth initiatives and key transformation programs, digital transformation, production and manufacturing capabilities. And on that, remember, we had announced EUR 300 million investment in the biotech plant. We also announced last October, the acquisition of a new research and development campus in the U.K. and this will explain the temporary increase of our CapEx. And last, our M&A and business development approach. So the strategy is to sustain and continue growth in key strategic areas. We are more focused, as you've seen with the examples in 2020 with Ra Pharma, Engage Therapeutics and Handl, we are more focused on bolt-on transactions than on transformational deals. Second, our dividend distribution. So our cash flow generation has been solid, and it allows to offer a gradual increase of our dividend, which is consistent with the long-term growth prospects of the company, and the Board of Directors will propose a dividend of EUR 1.27 per share to the next AGM. And just as a reminder, we have a share purchase program in place to compensate for the dilution of our equity-based long-term incentives. And last point on our balance sheet, despite the acquisitions done in 2020, we end up with a net debt to adjusted EBITDA ratio at a healthy level of onetime, which is directionally where we want to be, and of course, without the temporary impact of potential acquisitions, which can take us above this level if we have the right investment opportunity. Now moving to the next slide on our guidance in 2021. We have framed it in the global context of the pandemic. And of course, we will continue to closely monitor the impact it can have. So for 2021, we're guiding revenue between EUR 5.45 billion and 5.65 billion, which reflects the continued growth of our core products. There is a bit of an FX headwind, which is included in these numbers. And as you can see on the right side of the slide, we confirm our estimated peak sales for the future sales of Cimzia, Vimpat and Briviact. And I can add that we should achieve the EUR 1.5 billion peak sales of the impact already this year. Adjusted EBITDA margin is estimated between 27% and 28%, with R&D expenses around 30%. And our EPS is estimated between EUR 5.6 and EUR 6.1 per share. It's built with an estimated tax rate around mid-teens. And I would add that the second half of our financial cost in 2020 is more reflective of our expectations for the financial cost in 2021. So that's it for our '21 guidance. And with that, let me hand over to Jean-Christophe.

Jean-Christophe Tellier executive
#7

Thank you very much, Sandrine. And to close this -- the first part of this presentation, let me explain to you a little bit where we aim to be in 2025. You have seen the progress that we have made in our pipeline. You have seen the strong financial results that we are delivering this year. And Sandrine has just shared with you the guidance and the outlook for 2021, which will represent an eighth year of continuous growth for the company. But we wanted to go further and we wanted also to share with you the confidence that we have on our long-term and sustainable growth. And that's the reason why we would like to share with you where we want to be in 2025. so I think you will see that on the next slide. I think I mentioned that in introductuion, we are living in a transition period from an environment standpoint. In the pandemic, no doubt will create a new environment going forward. But I would like also to share with you that we are also transforming the company and you see progress year after year of our growth strategy and the addition of the pipeline that we are putting together. And so UCB is transforming itself. First, by these new products and these new products will create additional growth and will help us to, of course, overcome the loss of exclusivity that we will have in the coming years. But on top of new potential launches and new products in our portfolio, we are also investing into new platform and new technology. The partnership with Lacerta, the acquisitions of Handl Therapeutics earlier at the end of last year, demonstrated -- illustrates this desire and this strategic objective to strengthen our capabilities in gene therapy. The third element of this slide is the digital transformations. I mentioned it as an accelerator because of COVID, and UCB is also transforming itself through this digital transformation. I just would like to illustrate this point with a few concrete examples. The first is the partnership that you have seen that we have signed 2 days ago with Microsoft. This partnership is a follow-up of the first partnership that we had with them around the year, COVID won't shut the initiative. This partnership for us is built on 4 key elements and pillars. Four: First is the ability to accelerate the cycle of discovery, leveraging their ability and our scientist to try to accelerate the ability to detect earlier on and to fast track the discovery of new candidates; Two, it's also with the aim in mind to accelerate clinical development; three, it's making sure that we get a better understanding of human biology, and by doing so, create new insights on the causes of diseases, particularly the chronic disease we are particularly interested in. And finally, thanks to these partnerships, we aim to better understand the whole patient journey and discover more patient treated outcome that can help to understand different phenotypes that can be translated into more precisions in the treatment that we will create. Microsoft is a partnership that we have started and continue in the future, but the digital transformation started a few years ago at UCB. And we are today already benefiting from some of that. I would like to illustrate that quickly with you example. Iris mentioned the digitalization of our clinical development program. Roughly now 60% of our patients' visits are done remotely. By doing so, we increase, of course, the security and we protect the clinical continuity of our trials as well as the patient safety. Two, because of COVID, of course, we had to move to a virtual contact with a lot of our stakeholders. In 2020, thanks to the digitalization's of these operating model, we have been able to compensate almost fully the lack of face-to-face meetings with our stakeholders. We have also been able through predictive analytics, and Emmanuel mentioned that, to improve the efficiency of our go-to-market model by being much more precise and value-based on our activities. And the last example that I can illustrate with you is our patient safety monitoring and processes where, thanks to digitalization, we have been able to reduce cost by 70% and increased speed of treatment of the cases. These are just few elements to illustrate that the digitalization is already ongoing, and it is something that will accelerate in the future. And last, but not least, we are able to do all of that because of our people, the ability to create an environment that allow our people to be at their best is a critical component of building a strong future for the company. Next slide. And so that's the reason why we are optimistic in our ability to lead in 5-patients population in the future. You can see here these different patient populations and the products that will help us to lead in these indications. You will not see any surprises here. We do feel that we are already leading, and we will continue to lead in the in the [indiscernible] in the 5 years period. Thanks to the portfolio in autoimmune information. We are confident that we will be able to lead with our differentiated assets and the complement that bimekizumab will create to Cimzia in the near future in psoriatic arthritis patients. You know that Cimzia and the unique structure of the molecule, but also with Keppra and the experience that we have acquired with Keppra, we are on our way to lead for treating this disease for woman of childbearing age. And Iris mentioned the complementarity and the synergy in our portfolio in myasthenia gravis with zilucoplan and rozanolixizumab that will allow us to lead in this disease population. So our aim, our objective is clearly to become leader, if not already there, for these patient populations, thanks to the pipeline that we have and the product that we have in our hands. I forgot to mention Evenity, Emmanuel had mentioned. Evenity with the unique ability to build bone after a fragility fracture, which is an important medical need. Evenity is a unique product that can deliver that. Next slide, please. And so that's the reason why building on this ability to lead in these 5 patient populations, we are confident that we will be able to overcome the loss of exclusivity of a few products in the coming years and continue to grow. And we will be able to reach at least EUR 6 billion of top line revenue by 2025, with the ambitions to continue to grow and to be able to be more profitable in the future and reach low to mid-30s EBITDA by the same period of time. You see here also our green strategic objective that we have already disclosed a few years ago for 2030, that are confirmed with this carbon neutrality by 2030, the reductions by 20% of water consumption and waste production by 25%. So really strong ambitions, a very good confidence in our pipeline moving forward and an ability to continue to grow and to provide sustainable growth for the company based -- and it's the last slide, if I can move to the next slide, based on our ability to really create value for patients, which is our sense of purpose. With that, I would like to thank you for your patience and we'll go back to Antje to open up the Q&A. Antje?

Antje Witte executive
#8

Thank you very much. So I'm happy to start the Q&A session as of now, please you have done so very many, many questions. If I may, I start with Richard Vosser from JPMorgan. And he is asking how -- on the midterm targets, could you give us an idea how you see the trajectory of margins developing through to 2025. And I think this goes to Sandrine. Second question, this goes to Sandrine from Richard is how should we think about the other revenue line developing through 2021 and 2022 and beyond? And he also had a question about CIDP. He's asking -- you mentioned that the rozanolixizumab Phase II CIDP efficacy data would support a confirmatory trial in the 30% of CIDP patients you've site this detectable autoantibodies. How strong was the efficacy you saw with the roza-combo and was it similar to ig-mono or substantially better? I think this goes to Iris. Perhaps Sandrine you'll start it.

Sandrine Dufour executive
#9

Yes. Thank you, Antje. Thank you for the question. So I will start by the question on the '25 trajectory. And what I would say is that we are committed to this long-term growth and improve profitability. I don't want to comment on the shape of that. But what I would say is that when you model that, we certainly take into account the dynamic of the sales, including the expected launches, including the loss of exclusivity and I think that's what we can say now on that. And on the second question, which was on the other revenue line, how we see this? So it was a one-off, I would say, in our 2020 numbers. So you should more look at the level of 2019 to get a sense of what we would expect that this year.

Iris Löw-Friedrich executive
#10

Yes. And Richard, thank you for the question on CIDP. So I indicated that the Phase III study would support going into confirmatory development. We still have, I believe, the last patient ongoing in the Phase II study, and as always, we will share the results at an upcoming congress. Of course, we have independent data monitoring committee that continues to monitor patients efficacy and safety, and that has assured us that rozimab has behaved as it should behave. The decision related to CIDP is a strategic decision. I want to reiterate that because we have evaluated and we have discussed that before, the potential patient populations that are underserved and where we have auto antibodies as the sole or predominant reason for the disease biology. And this is where we have identified in the strategic review, patient population underserved, high unmet medical need and where the disease biology is clear, mainly related to autoantibodies. With CIDP, as I have mentioned, the picture is less clear. Now HUMIRA and you have cellular immunology involved. There's not enough basic research and understanding. It's a heterogeneous patient population, and we see that heterogeneity also in our blinded Phase II data. So we think that we can allocate our resources to more targeted therapeutic approach for those patients with clearly different autoantibodies as a sole of primary underlying disease condition. And that's the only driver for the decision to not continue in CIDP, but to move into new patient populations. And we'll update you in due time on this population.

Antje Witte executive
#11

Thank you very much Iris. Next questions are coming from Laura Sutcliffe from UBS. And I think this goes to Emmanuel and Charl. What impacts do you think anti-TNF reference pricing in Europe will have for UCB? And to what extent is this captured in your guidance? How do you see Cimzia's price evolving in major European markets over the coming 2 to 3 years? And question on Vimpat, do you think consensus already adequately captures the erosion you expect for Vimpat. Perhaps, Emmanuel, you start?

Emmanuel Caeymaex executive
#12

Yes. Thank you. So on reference pricing in Europe, it is not necessarily a mechanism that every country is using. I believe, Laura, you're referring to the Jumbo group in Germany, which has been moved forward by 6 months from October to April. So first, it is limited to anti-TNFs. Second, yes, we have included this in our guidance. And to give you a sense, it's costing us a point of growth on Cimzia growth of sales. I wouldn't expect the erosion of prices in Europe to go much beyond that on an annual basis, given that this is the largest market, and it's also pretty significant move. And the last point I would say is, as those things take place, it gives us an opportunity to reduce other rebates as well. So there are some compensating effects of this year as well. Was there another question about Cimzia?

Antje Witte executive
#13

What do you expect in the European markets in the next 2 to 3 years, I think you answered this? So I think you can give it to Charl for the Vimpat question.

Charl Van Zyl executive
#14

Yes. Thank you, Laura, for that question. And I think just to reiterate how we've also given guidance in the past, our assumptions for the Vimpat LOE is that the U.S. erosion will be 80% in the first 12 months; and for the European markets, 50% in a period of 2 years. So from all the assumptions we have today, we see that guidance remain firm. And that's what you would use as your modeling guidance for your understanding of Vimpat LOE impact.

Antje Witte executive
#15

Thank you very much. This also is preempting one of the questions I got from Trung Huynh, Crédit Suisse, there's still left something, Sandrine, the 2022 guidance, how do you stand to your guidance of 31% for 2022 given earlier? Then he wants to talk about a little bit about '25 guidance. Is the EUR 6 billion revenue guidance, probability adjusted or an aspirational guidance. And on rozimab, he would like to know from Charl or Iris, I would say, Iris. What are the other neurology indications you pursue for the rozimab and he's proposing 2 acronyms, NMO and ALS as a proposal? Sandrine, do you want to start with the 2 guidance questions?

Sandrine Dufour executive
#16

Yes. Can you give me?

Antje Witte executive
#17

Yes.

Sandrine Dufour executive
#18

Yes. So on the first one, what I would say is that we are committed to the long-term growth and the improved profitability, and we are confident to achieve the low to mid-30 EBITDA margin by; '25. And as for '22, we will come back in 1 year with providing the detailed guidance, all the KPI 1 year from now. So that's really to frame how we want to project the guidance for the future. And on your question on the '25 one, the way it is -- it's based on what we call our working scenario. So it's not probabilized, It reflects our best estimates of the future outcomes.

Iris Löw-Friedrich executive
#19

Yes. And Trung, thank you very much for your engagement and for your contribution to our strategic discussions, much appreciated. You will understand that I reiterate that we will talk about the 2 additional patient populations with autoantibodies as underlying disease in the neurology space when the right moment comes. And I'm really looking forward at the right point in time to share in more details with you. Thanks very much for your understanding.

Antje Witte executive
#20

Thank you. The next question is from Jean-Jacques Le Fur from Bryan Garnier. Emmanuel, he likes to know for Evenity, should we expect another difficult year in 2021? Or do you see some encouraging signals since the beginning of this year? And second, how do you see the battle with argenx in myasthenia gravis, ITP, CIDP, since they are slightly ahead of you. Emmanuel, you start?

Emmanuel Caeymaex executive
#21

Yes. Thank you, Antje, and thank you, Jean-Jacques. 2020 has been a pretty good year for Evenity. Of course, without the pandemic our alliance would have achieved further growth. That is for sure. So it's probably too early to speak to 2021 in terms of the first 1.5 months. But I do think that for Europe, we will be in a situation with a full year in the markets where Evenity has been launched in the middle of the pandemic, and that is Germany, Sweden, Denmark, a few markets like that. We will also have new markets joining with nice reviewing Evenity in the first half of the year and other markets to follow suit. So there's a lot of sources of growth there. And for out of Europe, I would just refer to the optimism from our Amgen partners, which they voice that their results offers?

Charl Van Zyl executive
#22

Jean-Jacques, thank you for your question as well on argenx. So first of all, I think just as Iris reiterated earlier, we have a very strong value proposition with our solutions. We have essentially 2 modes of actions with zilucoplan and rozimab and provides essentially 2 options or choices for physicians to treat myasthenia gravis on a continuum of care. So our scientific value proposition. Our proposition of these 2, we feel is very compelling to provide options and to meet patients with the needs that they have. In a sense, where I would say the anti-FcRns will really be an important solution in patients who require IVIG treatment here. This is an 11 billion plasmapheresis market. So we really should not compete with each other, but really look at the unmet needs in the sense where IVIG patients require a new solution, and we believe anti-FcRns can significantly improve the quality of life, the outcomes for patients in that space.

Antje Witte executive
#23

Thank you. I have another question from Wimal Kapadia of Bernstein. And I think it again goes to you, Sandrine, about the guidance. He likes to have some more context on the '25 guidance. In particular, what assumptions have been made on Cimzia biosimilars, success of rozimab and myasthenia gravis in ITP and bimekizumab across the multiple indications. And he also would like to know, perhaps, again, a reminder, Charl, on the patent expiration expected for Vimpat in the United States, what speed of decline should we just consider. And from you, Emmanuel, he likes to have a little context on the assumptions for the bimekizumab launch in our 2021 guidance, what level of contribution could we expect from the product? How should we think about coverage for the product at launch? You want to start, Sandrine?

Sandrine Dufour executive
#24

Okay. Well, I'll start. I'll be quick because the intention is not to give detail on the underlying assumptions of the '25 guidance, but we have reflected as part of our plan, the key underlying assumptions, including the pricing environments, and we feel confident with the number that we are aiming to achieve at least EUR 6 billion.

Charl Van Zyl executive
#25

Antje, we move to the question on ITP and rozimab, if that is the next question, then I would just reiterate that. As Iris had mentioned our commitment to rozimab remains unchanged of -- potential we see is unchanged. We see this asset as a 1 billion-plus potential in peak sales, the indications, and in due course, as we progress, we will be able to disclose more specifically on ITP. I think the second question was related to more specificity on Vimpat LOE. So the date for the LOE is March 2022 in the U.S. And the expectation from all the historical modeling, we see is 80% erosion in the first 12 months post LOE for the U.S. market specifically.

Emmanuel Caeymaex executive
#26

And to follow-up on the question related to bimekizumab's contribution to our 2021 goals. Both -- I'd say the first determinant is to actually gain approval for newly launched assets, the time of approval is conditioning the sales in a given year to a very high extent. That is, of course, in the hand of the regulators. And as mentioned earlier, we are expecting to enter the U.S. and certain European markets in the second half of this year. In terms of coverage and access, with the quality of the evidence that we have available, I would say that for most payers, it's a relatively straightforward equation. Of course, in the U.S., we will enter a market which has existing contracts in place. And what I can say is that there's a good level of eagerness with payers to make these new and differentiated assets available to their patients with moderate-to-severe psoriasis. Thank you.

Antje Witte executive
#27

Yes. Thank you. Next question is from Richard Parkes from Exane. And Iris, he likes to go back to the 30% of patients with an identified autoantibody. He thinks that there is a hypothesis of a higher portion of patients than that, who might benefit from treatment. So he is trying to understand whether our decision reflects lowered expectations of these percentage of patients that might benefit versus identifying those patients upfront versus simply a case of seeing greater opportunities elsewhere. And if you want to add something to the bimekizumab comment you just made, Emmanuel, he's asking, can you talk about expectations for bimekizumab market access when you launch. I presume you will initially be limited to the commercial channel. So can you talk about what we might expect for the pace of the launch given the -- given need to negotiate access. Iris?

Iris Löw-Friedrich executive
#28

Yes. Thank you, Antje. Richard, thank you. I want to reiterate this is a strategic decision that we have taken in the light of opportunities around patient populations with unmet need and a very crystal clear described autoantibody pathology. You're aware that there is different autoantibodies, you even have autoantibody populations in CIDP, which do not respond to IVIG. There's a lot of unknown around the cellular contribution -- cellular immunity contribution to the pathology. There's other mechanisms that are at play. And for us in the light of this complexity, in the light of the very limited clear contribution of autoantibodies, we have taken a strategic decision to focus on those populations where our paradigm of high unmet medical need and autoantibodies as the clear disease pathology is the most robust. So that's the explanation. We do not want to participate in basic research in CIDP at this stage. There's a lot of work that still needs to be done to understand the disease mechanisms, which are very broad and again, largely unknown. Thank you.

Antje Witte executive
#29

Thank you, Iris. Emmanuel, anything you want to add?

Emmanuel Caeymaex executive
#30

Yes. perhaps to say that in the U.S., the market is mostly a commercial market. So the public portion is actually quite limited. We are very focused on commercial payers. And it's a little too early to be able to describe in detail how that might look like. But of course, we're working very hard to make these assets available for those patients that needed the most. And in Europe, we have a number of markets which, where access is actually available from approval date onwards, I would say Germany with pricing and reimbursement negotiations going on in parallel with commercial launch. And of course, we started early with other payers like in the U.K., for example. So I would expect to derive sales and the fairly good access in these places as well.

Antje Witte executive
#31

Thank you. Next question from Lenny from KBC. Sandrine, he is showing little bit on our margin guidance. And wonders why we are maintaining a strong revenue outlook, it indicates higher-than-expected spending. And he's asking, does this signify increased cost of ongoing commercial rollout and clinical experts or does it reflect an increased willingness to invest into expansion?

Sandrine Dufour executive
#32

What I would say on the guidance is that one of the elements that we have mentioned, an expected level of R&D, which is around 30% in '21. So it's a percentage point higher than in 2020. And so that's one element which explains where we are. And of course, as we said, 2021 is the year of launching bimekizumab, and this is reflected as well in our marketing and sales expenditure. So that's the key underlying assumptions for the year.

Antje Witte executive
#33

Okay. I have -- I'm going to combine 2 questions, 1 from Charles Pitman and 1 from Rosie Turner, if you allow me. They want to know from you, Emmanuel. Again, formulary access for bimekizumab, do you think you will have a stepped access, meaning after having failed Cosentyx. And also, Charl, want to like -- want to know if the Cimzia drop in rheumatoid arthritis, how we should think about the impact of generics and can you expand a little bit on the mentioned government induced price pressure expectations or perhaps you talk a little bit about volume growth, price impact in Europe. Emmanuel?

Emmanuel Caeymaex executive
#34

Yes. Thank you. So obviously, a lot of interest around the payer position with bimekizumab. You understand it is really early to be able to comment here. What I would encourage you to do is to think about access as something that is dynamic with every 6 months, every year, negotiations and renegotiations. And also with the fact that in 2023, the U.S. market will undergo profound change with HUMIRA, losing its exclusivity, which, of course, will have a high-impact on rebates in the immunology field, which, of course, are an important factors that the [indiscernible] are looking at. Could you just repeat the question on Cimzia, Antje, please?

Antje Witte executive
#35

The decline of rheumatoid arthritis, and the government induced price reductions you were alluding to during your presentation. What -- if you could elaborate a little bit more on that?

Emmanuel Caeymaex executive
#36

Yes. So the decline in RA is actually incremental. What we're seeing is that woman of childbearing age suffering from RA are actually a fast-increasing proportion of our rheumatoid arthritis patients. So you have a decline that is triggered by biosimilars and also the expand of JAK inhibitors, although with the latest that might abate a little bit. And that is almost fully compensated by the increasing market share of Cimzia in the woman of childbearing age demographics. So I see this continuing. And thereby, I'm not foreseeing an acceleration -- a very significant acceleration of the decline. And then in terms of the pricing pressures, I think it's -- frankly, it's anybody's guess, right? What we do know is that governments are -- we'll be looking for funds to finance COVID-19 related packages as well as from a little closer to trying to limit debt. And therefore, we are expecting that over time, in different geographies, there will be additional asks compared to what we already know. So it is baked in our guidance to the extent that those things are clear and confirmed. So it's -- I can't give you more. It's hard to predict. But I do think that in a large market like immunology with the presence of biosimilars, clearly this will be one of the first places that payers will go at.

Antje Witte executive
#37

Yes. And looking to the time, I take the liberty to call out the last 3 questions, if you allow me. And please, we will -- you know where to find us, so that we can continue the conversation. Alex is asking, given your vision for the treatment of generalized myasthenia gravis patients, what kind of patient numbers do you expect to be markers for zilucoplan and rozimab? I think this goes to you, Charl. And to Iris, the question about the bepranemab situation? And a last question on taxes. Peter Welford from Jefferies is asking Sandrine. Can you explain the midterm tax trajectory? And why it's now -- Why is it now lower than before? Thank you very much. Charl, you like to start?

Charl Van Zyl executive
#38

Yes, I can just -- Alex, thank you for your question. We will not disclose specific patient numbers at this point, but I would just, again, emphasize that what we know today from our insights on patients in myasthenia gravis is that at least 50% of patients are well controlled. And so there's a significant market opportunity for the new entrants and the new solutions we are providing. So we feel very confident with the potential that we see in this market and for these patients.

Iris Löw-Friedrich executive
#39

Yes. And Alex, thank you for your question about the bepranemab which is our tau antibody, and you remember that our tau antibody was designed and developed based on human material. So we are targeting central epitope, which is quite different from other tau antibodies. We have partnered bepranemab last summer and that has given us the opportunity to merge our Phase II aspirations into Alzheimer’s disease Phase II study. What we want to do is, of course, provide proof-of-concept in a tauopathy and tau plays a role in Alzheimer's disease. And in the context of the partnership that tau represents a derisked option and, of course, great potential. So on 2 Phase II studies, we've settled together with our partner on 1 study showed proof-of-concept for bepranemab and our tauopathy in Alzheimer's.

Sandrine Dufour executive
#40

I'll take the question on tax, you see we transform the tax rate?

Antje Witte executive
#41

Yes.

Sandrine Dufour executive
#42

Okay. So maybe I can start just on 2020 before looking at the tax ratio going forward. And on 2020, the effective tax rate of 13.5% to be precise, was driven by one-off transactions, which increased the benefit of previously a new [indiscernible] tax And as you know, the company continues to benefit from tax incentives, which are linked to innovation and R&D. And If I look at the projection of the tax ratio, we forecast ratio in the mid-teens going forward, driven by the tax intensive linked to innovation and R&D. Now I'd like to say that there's a large amount of unrecognized tax reductions, which we carried forward from prior years. And it's expected that the rate will temporarily drop in the near-term future, not for this year, probably not for next year, but beyond.

Antje Witte executive
#43

Okay. Thank you very much. While not everybody was able to ask every question. I hope I was able to collect those because the main interest was around the guidance, '21 and '25 as well as CIDP and as well as bimekizumab. So all on me, if you have open questions, please come back to us and the Investor Relations team. We are here for you. And for all investors, we are looking forward to meet you on the virtual stream in the coming weeks. Thank you very much, all. Stay well and safe and take care. Bye-bye.

Operator operator
#44

Thank you. Ladies and gentlemen, this concludes the call and webcast has now concluded. Thank you for joining, and have a good day.

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