Good day, welcome to the UCB Investor Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero . After today's remarks from UCB, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. To withdraw your question, please press star then two . Please note, this event is being recorded. I would now like to turn the conference over to Antje Witte, Head of Investor Relations. Please go ahead, Antje.
Thank you, Betsy, and a warm welcome from my side. Good morning and good afternoon. It's just my privilege to remind you that this call and the Q&A session are covered with the forward-looking statements, as is laid out in the press release issued yesterday evening at 6:00 A.M., or if you refer to the RYSTIGGO press release this morning at 7:00 A.M. You'll find the appropriate disclaimers in these releases, page two or the last page. With that, thank you so much, and I'm handing over to our CEO, Jean-Christophe Tellier.
Thank you, Antje. Good morning and good afternoon, everyone. As Antje mentioned, we had a quite important sequence of news flows recently and we thought it was a good idea for us to engage with you. So thank you for your interest into the company and your participations into this call. The first topic, of course, I would like to cover is this, the BIMZELX information that we shared with you yesterday. We thought that it was a good moment to inform you that the Q2 timeline that we were confident before to receive the action from the FDA is no longer appropriate and so, w e thought it was a good.
It was appropriate to inform you on the fact that we think now that with the ongoing dialogue that we have with the FDA, it will likely be more in Q3 than in Q2. Two element that I would like to mention on top of this information. The first one is that we take the initiative of this communication. It's not because we have received any actions or letter or anything from the FDA, but it's more that, from our perspective, it's unlikely, we think that FDA could take actions between now and the end of the week. So we thought it was better to inform you from a shift of few weeks until latest at the latest in Q3.
The second element that I would like to share with you also is that we don't have any open questions that remain with them; so i t's just a question of needing more time for defining this this action but i t's not that there is new questions or thing that has been unclosed or not answered so far. We are in this phase where we have answered the question , t here is no more information request; w e are, of course, engaging with the FDA, but as we have said earlier, we keep the conversations, the dialogue with the FDA private and so we don't disclose that we thought that it was more appropriate to to switch that to Q3.
It doesn't change the guidance; and so we confirm our previously guidance range for 2023, with a revenue between EUR 5.15 billion and EUR 5.35 billion of revenue, and EBITDA between 22.5 percentage point and 23.5 percentage point. That's the first information that we wanted to come back to you and share with you live. From another product perspective, you have seen this morning that on the other end, we had an FDA approval this morning; this was granted under the priority review designations for our product RYSTIGGO, an anti-FcRn in Generalized Myasthenia Gravis (gMG). Of course, we are very pleased with these results.
It's a great additions to our portfolio, and I will let Iris comment more on the broader spectrum of education that we are very pleased that we have achieved with RYSTIGGO. Last but of course not least, from a people standpoint, you also have seen that one of our colleagues, Charles van Zyl, has been appointed future CEO of Lundbeck. We are of course, very pleased for him. I think it's a great opportunity for him. I think also it's a great recognition of the talent that we have at UCB. I'm pleased to see that our people, our talent have a tremendous value on the market and are looking by others as a very unique type of talent.
I'm wishing him the best for his next step in his career and very pleased for him. It's a great opportunity, and I'm sure it will be great. We will inform you about successions in due time, but we wanted to share that with you also as we are gathering and sharing the updated information. Now I hand over to Iris, who will maybe go a little bit deeper about this product news.
Yeah. Thank you very much, Jean-Christophe; and good morning and good afternoon to all of you on the line, I will echo and expand on Jean-Christophe's comments and I start with BIMZELX. Really, our commitments to you are very important to us, and it's important to us that we honor these commitments. We had promised to inform you if the review of the BIMZELX BLA would continue beyond second quarter and o f course, we understand the mechanics at the FDA, the processes, and the interactions; and so, we have realized that we need to adjust our timelines and that triggered last night's press release.
With four days to go to the end of the quarter, it has become quite obvious for us that based on our current knowledge of the status of the review, we will not see an FDA action before the end of the week. I really want to underscore, Jean-Christophe said it already, that yesterday's communication was triggered solely by our commitment to transparent communication to you. There's nothing else. We own this commitment to you and we feel very accountable to honor our commitments .
Let me be crystal clear. There was no trigger by FDA, there was no deferral, no major amendment, nothing. We did not receive any action letter by FDA, not even any specific communication from the agency. The review by the agency is ongoing as it has been in the past weeks. Nothing has changed.
I think we need to acknowledge that the review progresses at its own pace and it will take longer than we had hoped.
I also want to make sure that you recognize that the UCB team is very responsive to any information request or any questions from FDA. We deliver answers with highest quality and within very tight timelines. We have no open information requests at this stage. We recognize that FDA simply needs more time and we want to remain a highly collaborative partner for FDA in this process.
Based on the past experience and our understanding, we now expect FDA action on bimekizumab, BIMZELX, during the third quarter. I think I do not have to remind you of the strength of the bimekizumab data -- o ur efficacy has been proven not only versus placebo but also by superiority over standard of care.
Of course, the benefit risk is very positive; and p lease also remember that BIMZELX is already approved in 39 countries by 10 different regulatory authorities. There's 9,000 patients who are living with psoriasis and who are currently treated with BIMZELX in our global markets. You know that we have just received approval for BIMZELX in the European Union for the psoriatic arthritis and Axial Spondyloarthritis (axSpA) indications; and w e are launching in Germany as we speak, with more than 30 patients already on BIMZELX in two weeks. I hope you hear and sense that our confidence, my confidence, is rock solid and we are convinced that FDA will take action and will ensure that patients in the U.S. will have access to bimekizumab as well. Of course, let me switch gears a little bit and move over to the neurology division.
You recognize that we have many interactions with FDA these days and we are delighted, truly delighted, that Rozanolixizumab, which is now RYSTIGGO, has received FDA approval last night. You remember that following our submission end of last year, FDA assigned priority review to the asset; we did not ask for it, w e did not pay for it. The strength of our data overall and obviously, our data set in patients with Generalized Myasthenia Gravis (gMG) , who are MuSK (Muscle-Specific Tyrosine Kinase) antibody-positive -- have triggered the priority review because so far there's no targeted therapy available for these patients; and this overall very strong data package has now resulted in the first indication in the United States for the treatment of Generalized Myasthenia Gravis (gMG) in adult patients who are acetylcholine receptor (AChR) antibody or MuSK (Muscle-Specific Tyrosine Kinase) receptor antibody positive.
You can imagine that in combination with a convenient administration route and dosing scheme, we expect to make a very positive impact on the lives of people with Generalized Myasthenia Gravis (gMG) in the U.S., launching in the next weeks. As you know, we are bringing a portfolio of products with different mechanisms of action to patients with Generalized Myasthenia Gravis (gMG) . Just remember that zilucoplan, our complement C5 inhibitor, is also under review by the agency. Our ambition has been and remains to ensure that patients with Generalized Myasthenia Gravis (gMG) can have an individualized solution for their specific needs and circumstances. Please rest assured that FDA actions will continue to come, that's for sure. We will be successful with our very exciting molecules and strong and robust data packages.
With that, I thank you very much, and we will now open the call for questions.
The first question today comes from Simon Baker with Redburn. Please go ahead.
Thank you very much for taking the questions, and apologies for the background noise. I've just got off the phone. One slightly odd question but what gives you confidence that the FDA will not complete the process this week? Is there a specific event that has not yet happened? Any color on that would be helpful. A slightly broader question. I know while this has been going on, you've been working on pre-launch planning, awareness, access. I wonder if you could just give an update on where you stand with the commercial position with BIMZELX in the U.S.? Thanks so much.
Yeah, Simon, thank you. I take your question on has there been any specific event? No, there has been no specific event; of course, we are very familiar with FDA processes and FDA interactions, w here we stand right now with the review does not indicate that we will have an action by Friday and so we did not want to wait until the very last minute; again, to honor our commitment of transparency to you, we felt it was important that we let you know as soon as we ourselves were sure that no action would happen this week-- Let me repeat it -- we have not received any specific communication from FDA, t here was not anything that we expected that did not come; re ally nothing specific.
We are having this press release and the interaction today because we want to honor our transparency commitment to you and we don't see any action by FDA in the next, what is it? What's left, three days.
Maybe, Simon, on your second question, two ways to answer this question in from my side. First is, our teams are ready -- t hey are on the starting block, t hey have been on the starting block for a while, they are ready to launch the product as soon as we will have an opportunity to do so; but it's, of course, it's not linked on us, it's linked on the agenda and we are not managing the agenda completely. So we are ready, and we will be ready whenever the date is defined and will come. From a stakeholder standpoint, we are engaging with the stakeholder on the regular basis and we have been doing so for a while also.
What does it mean in terms of PBMs, payers, plans, stakeholders? As Iris said, in the same vein of transparency and commitment to you and we have the same transparency and commitment to them; w e are in dialogue with them, w e want to make sure that the purpose of the publications of yesterday also, that with that, they can also from their side, anticipate how at best manage their patients or their stakeholders with this news so w e are engaged with them, we are in a continuous dialogue with them in order to make sure that as soon as we have the opportunity to bring this product available for the patient, we will have an environment that will facilitate support and we'll be engaged to that.
The next question comes from Xian Deng with UBS. Please go ahead.
Thank you. Thank you for taking my questions. Two, please -- t he first one on bimekizumab, if I may play a bit of a devil's advocate; what could be the potential risk for approval at this stage? You know, what, for example, your form 483 [unclear audio] , just wondering, you know, anything else that you can see as a potential risk at this stage? Second question on Rozanolixizumab, please -- Because now the label actually includes MuSK (Muscle-Specific Tyrosine Kinase) positive patients. Just wondering if you could maybe remind us what, you know, the sort of the physician dynamics there. You know, what are those patients receiving at the moment? Do they have, I don't know, off-label anti-FcRns or Soliris, Ultomiris, and how should we think about the commercial opportunities there?
Thank you very much.
Yeah, Xian, thank you very much. On your first question on the risk to approval of bimekizumab at this stage, please, you know, we have a policy that we are not commenting on ongoing reviews; I will not start speculating on any potential risks, t he review is ongoing -- w e are in conversations with FDA, w e have no open information requests; our teams are responding if there will be new questions coming from the FDA and p lease, let's leave it with that; we have an ongoing interactive review.
On your topic on RYSTIGGO and the label, which includes both populations, right? The acetylcholine receptor positive patients and for the first time in the U.S., the MuSK (Muscle-Specific Tyrosine Kinase) positive patients, MuSK (Muscle-Specific Tyrosine Kinase) antibody positive patients. Acetylcholine receptor positive patients are about 80% of the population.
The MuSK (Muscle-Specific Tyrosine Kinase) , antibody-positive patients are between 10% and 15%; and t hese patients currently are being treated with unspecific treatments, corticosteroids, immunosuppressants, and of course, may also receive IVIG; it's the first time and we're very happy that we have been able to provide this data, that we have a molecule with Rozanolixizumab with RYSTIGGO, that has clearly demonstrated that the disease activity in the patients with MuSK (Muscle-Specific Tyrosine Kinase) auto-antibodies substantially decreases while these patients deteriorate under placebo; v ery happy to have provided an advantage for this subgroup. Very much in line with the overall efficacy that we are seeing with RYSTIGGO in all patients with Generalized Myasthenia Gravis (gMG).
Thank you very much.
The next question comes from Kerry Holford with Berenberg. Please go ahead.
Hi. Thank you. A couple of questions for me, please. Firstly, can I just check my understanding here based on your commentary today? It sounds as if this is not a specific delay to the timeline set by FDA, but rather a case of this falling on the other side of the quarter. Is that fair? Can you also confirm whether there's any specific timeline now by which you expect a decision going forward? Any clock that's ongoing now or we're just rolling? My second question, in the context of transparency going forwards here, can we expect UCB to inform the market here on if it receives another communication, whether that's a Form 483 or any other request for additional information from the FDA? Thank you.
Yeah, Kerry, thank you. Can I reiterate? There has been no action in any way from FDA, so there is no new clock that has been set; I've said it before -- no major amendment, no deferral, no communication from FDA that would get any way close to an official communication; really nothing, no new clock, i t's UCB in our huge accountability to be transparent to you who have decided to communicate that we think no action in the next four days; we believe if we look at the pace of the review at FDA which we have seen in the past, we will see action during the third quarter; there's no clock, it's our estimate based on past experience.
Because we are going out of our way to be transparent to you can assure that if there's any relevant communication from FDA, if we receive any action letter, we will keep you informed; I think today is really proving to you that we're very very serious about transparency and communication to you.
The next question comes from Stacy Ku with TD Cowen. Please go ahead.
Thanks very much for taking our questions; we have a few on BIMZELX and a few on RYSTIGGO -- if I could ask the previous questions differently, what gives you conviction that the BIMZELX approval may occur in Q3? The Form 483 appears very benign, but if we could explicitly ask, is there a need to reinspect the Braine facility? Then on RYSTIGGO, our consultants have discussed a wide range of patient preferences but could you also comment on managed care discussions for RYSTIGGO -- expected timing and expectations as we think about positioning in a two-player market for FcRns and myasthenia gravis? Thank you very much.
Again, with the commitment that we'll not release any details on the ongoing review, no matter from which angle you ask the question, we'll just stay firm on our policy not to release any details of our ongoing review; there is nothing to add at this stage. We have been delivering. Yeah. Jean-Christophe, will you take the second part of the question?
I will, maybe allow me to once again summarize the way we are thinking about this and the reason why we are not disclosing the private conversation that we have with the FDA; frankly, it's for me, it's the best way to be consistent, to be loyal, to be respectful and also to be fair with all of the stakeholders involved and ensure the same level of information for everyone and reduce the risk of misinterpretations or conclude on certain elements which, with very partial data. Imagine if we start to begin to answer your questions about how do we feel? What are the level of risk? What how do we interpret? What are the different steps? What are the different potential activities that we are doing?
Immediately, you know, I cannot control anymore what you will say and I don't want to control what you say, but you will interpret that in a certain way that may influence others to think about things that will be very far from the reality. To me, the best way to avoid these misinterpretations and false rumor and non-fact-based type of engagement, is really to stick to this policy, to say, "Well, it's a private conversation. We don't comment on that," and we just express what we think it's relevant. For the time being, for bimekizumab, it's, well, we cannot commit to the Q2 anymore, and we are confident that we will get an action in Q3.
I think that's the best way to ensure that everyone is the same level of information and we continue to engage with the FDA. Please, I hope that you also realize, as Iris said, that having said that, mean that we are highly committed to give you any important information as soon as this information is public, official, triggered by an action or a letter; it's not that we are hiding information, it's more with the objective to be fair, disciplined and fair with everyone. On the second question that you had on the RYSTIGGO, I mean, we have been able to illustrate in the past our view on this market in particular. Just two or three quick points on that.
Point number one -- these patients are now eager to move towards a more precisions medicines after having the need to go to the hospitals on a regular basis, i t's a major transformation for patients suffering from Generalized Myasthenia Gravis (gMG); it's great to see that there are different therapeutics, different products and different class also, to better address the need of these patients. We are already in a very unique positions because at the same time we have an anti-FcRn who target the ability of the body to recycle the IgG and to eliminate more IgG; t o do kind of a more natural IVIG or plasmapheresis outcome. At the same time, we have an anti-C5 with Zilucoplan that will provide more anti-inflammatory drug for these type of patients.
We are able to cover the different need of the patients, the different patients types and phenotype. You know, this disease is an autoimmune disease, so by nature autoimmune disease are very diverse; the patients are very different, one from the other, so it's also illustrated by the type of IgG that create the disease; s ometimes it's anti-acetylcholine receptor, sometimes it's anti-MuSK receptor, so that gives you the level of diversity of these patients. Being the first anti-FcRn with these double indications or double type of patients population, should give the physicians a huge relief that they don't have to think about what type of patients I have in front of me. Basically, with one solution, they can provide a good answer in both case -- in the anti-acetylcholine receptors and anti-MuSK positive receptors.
If you have seen the data, the data that we have on the anti-MuSK are really very significant, we are very pleased with that; we are engaging with the different stakeholders, physicians, scientific communities, managed care to make sure that we will be able to get the product as soon as possible on the market.
Our last question today comes from Charles Pitman with Barclays. Please go ahead.
Hi, guys. Thanks very much for taking my questions. Maybe just on RYSTIGGO, could you give us any guidance on what your pricing strategy is going to be here as you start these conversations with the regulator? Maybe just given your point about being in a unique position with Zilucoplan, how this could change upon a potential approval? Then just secondly, just in terms of kind of retaining your full year guidance, I know we discussed bimekizumab consensus on the call at FY 2022, I was just wondering if you were happy to reiterate your confidence in where the market currently sits for this? Thanks.
Thank you, Charles. On the RYSTIGGO and Zilucoplan, you know, once again, the ability to get the two products provide an ability to interfere with the physiopathology of the disease at a different stage and at a different level, that could help all of these type of patients. In terms of pricing, we always leverage pricing according to the markets and according to other products who are there; RYSTIGGO will be, by nature, a product which will be given to the patient with wave of dosing, w hen the level of IgG is high, then you have dosing of the drugs and then the IgG go low and then you wait until the IgG go back up again.
As you know, we are not the first one on the marketplace, so we have some kinds of price reference with the other products; Zilucoplan is a different value proposition because it's a daily injection. It's more like an insulin type of injection for patients with diabetes, so it's a much more chronic long-term treatment. Our objective for our patients is to be treated with the Zilucoplan and have more or less the same level also of pricing than ensure the control of the disease than with the other therapy.
We are not the first in the class in each of these categories, so we are looking and the different framing of these categories and we do not plan to be significantly different from a price per year to control the patient. Sorry, and on the guidance, I guess there's nothing to add to that, w e confirm the guidance from the company; w e do not comment on the consensus or we have not provided guidance specifically for BIMZELX outside of the U.S. or in the U.S. We will communicate on that later on.
Thank you very much. Maybe just a very quick, cheeky follow-up. When you said shift of weeks at the beginning of the call, can you confirm that that means you think this is more likely to occur in early Q3 rather than late?
Sorry, can you repeat the question? I mean, there was some connection issue. Sorry.
Apologies. Just earlier in the call, you highlighted that this announced transparency relating to a expectation for an FDA action in Q3 was a shift of weeks. Can you just confirm that that means it's whether it's likely to be to occur in earlier Q3 rather than later in Q3, based on your experience?
No, sorry. Sorry, I just wanted to. Thank you for the clarification. What I meant was Q3.
Thank you.
Thank you.
This concludes our question and answer session, and the UCB investor call as well. Thank you for attending today's presentation. You may now disconnect.