UCB SA (UCB) Earnings Call Transcript & Summary

Good day, and welcome to the UCB Investor Call. [Operator Instructions] 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 laid out in the press release, issued yesterday evening at 6:00 p.m. or if you refer to the RYSTIGGO press release this morning at 7:00 a.m. So you'll find the appropriate disclaimers in these releases, Page 2 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 participation 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 time line that we were confident before to receive the action from the FDA is no longer appropriate. And so we 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. 2 elements that I would like to mention on top of this information. The first 1 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. And so we thought it was better to inform you from a shift of a 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. And so it's just a question of needed more time for defining this action. But it's not that there is new questions or things that has been enclosed or not answered so far. So we are in this phase where we have answered the question. There is no more information request. We are, of course, engaging with the FDA. But as we have said earlier, we keep the conversation, the dialogue with the FDA private, and so we don't disclose that. But we thought that it was more appropriate 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 5.15 billion and 5.35 billion of revenue and EBITDA between 22.5 and 23.5 percentage point. So 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. So of course, we are very pleased with these results. It's a great addition 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. And last but, of course, not least, from a people standpoint, you also have seen that one of our colleagues, Charl 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 tremendous value on the market and are looking by others as a very unique type of talent. So I'm wishing him the best for his next step in his career and very, very pleased for him. It's a great opportunity. And I'm sure it will be great. So 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. But now I hand over to Iris, who will maybe go a little bit deeper about these product news.

Yes. 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. And really, our commitments to you are very important to us, and it's important to us that we honor these commitments. And we had promised to inform you if the review of the BIMZELX BLA would continue beyond second quarter. And of course, we understand the mechanics at the FDA, the processes and the interactions. And so we have realized that we need to adjust our time lines and that triggered last night's press release. With 4 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. And 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. So 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 time lines. So we have no open information requests at this stage. We recognize that FDA simply needs more time as we want to remain a highly collaborative partner for FDA in this process. And so based on the past experience and our understanding, we now expect FDA action on bimekizumab/BIMZELX during the third quarter. And I think I do not have to remind you of the strength of the bimekizumab data. Our efficacy has been proven not only versus placebo, but also by superiority over standard of care. And of course, the benefit risk is very positive. And please 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. And you know that we have just received approval for BIMZELX in the European Union for the psoriatic arthritis and axial spondyloarthritis indications. And we are launching in Germany as we speak with more than 30 patients already on BIMZELX in 2 weeks. So 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. And then, 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. We did not pay for it. The strength of our data overall and obviously, our data set in patients with generalized myasthenia gravis, who are MuSK antibody positive has 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 in adult patients who are acetylcholine receptor antibody or MuSK receptor antibody positive. And 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 in the U.S., launching in the next weeks. And as you know, we are bringing a portfolio of products with different mechanisms of action to patients with generalized myasthenia gravis. So just remember, that zilucoplan, our complement C5 inhibitor is also under review by the agency. So our ambition has been and remains to ensure that patients with generalized myasthenia gravis can have an individualized solution for their specific needs and circumstances. So please rest assured that FDA actions will continue to come. That's for sure. We will be exciting -- we will be successful with our very exciting molecules and strong and robust data packages. And with that, I thank you very much, and we will now open the call for questions.

[Operator Instructions] The first question today comes from Simon Baker with Redburn.

Apologies for the background noise. I just got a phone. So 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. And then a slightly broader question. I know while this has been going on, you've been working on prelaunch planning awareness access. I wonder if you could just give us an update on where you stand with the commercial position of BIMZELX in the U.S.?

Yes, Simon, thank you. I take your question on has there been any specific event. No, there has been no specific event. But of course, we are very familiar with FDA processes and FDA interactions. And where 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. But let me repeat it. We have not received any specific communication from FDA. There was not anything that we expected that did not come, really 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 last 3 days.

And maybe, Simon, on your second question, 2 ways to answer this question from my side. First is our teams are ready. They are on the starting block. They 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 stakeholders on the regulatory base and we have been doing so for a while also. And so what does it mean in terms of PBMs, payers, plans, stakeholders? As Iris said, in the same vein of transparency and commitment to you, we have the same transparency and commitment to them. So we are in dialogue with them. We want to make sure that the purpose of the publications of yesterday also that with that, they can also, from their side, anticipate how it best managed their patients or their stakeholders with this news. So we 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.

Two, please. So the first one on bimekizumab if I may play a bit of devil's advocate. So what could be the potential risk for approval at this stage? What -- for example, your own 483, Rentschler's 483, just wondering anything else that you can see as a potential risk at this stage? And second question on rozanolixizumab, please. So because now the label actually includes mask positive patients. So just wondering if you could maybe remind us what the sort of the patient dynamics there, what are those patients receiving at the moment? Do they have, I don't know, off-label anti-FcRn, Soliris, Ultomiris, and how should we think about the commercial opportunities there?

Yes, Xian, thank you very much. So on your first question on the risk to approval of bimekizumab at this stage. Please, we have a policy that we are not commenting on ongoing reviews and so I will not start speculating on any potential risks. The review is ongoing. We are in conversations with FDA. We have no open information requests. Our teams are responding if there will be new questions coming from the FDA. And please let's leave it with that. We have an ongoing interactive review. On your topic on RYSTIGGO and the label, which includes both populations, like the acetylcholine receptor positive patients and for the first time in the U.S., the MuSK-positive patients, MuSK antibody-positive patients. Acetylcholine receptor positive patients are about 80% of the population. The MuSK antibody-positive patients are between 10% and 15%. And these patients currently are being treated with unspecific treatments, corticosteroids, immunosuppressants, and of course, may also receive IVIG. And it's the first time, and we're very happy that we have been able to provide this data that we have a molecule, rozanolixizumab/RYSTIGGO that has clearly demonstrated that the disease activity in the patients with MuSK autoantibodies substantially decreases why these patients deteriorate under placebo. So very happy to have provided an advantage for this subgroup. Again, very much in line with the overall efficacy that we are seeing with RYSTIGGO in all patients with generalized myasthenia gravis.

The next question comes from Kerry Holford with Berenberg.

A couple of questions for me, please. Firstly, can I just check my understanding here based on your commentary today. It sounds that this is not a specific delay to the time line set by FDA, but rather a case of this falling on the other side of the quarter. Is that fair? And can you also confirm whether there's any specific time line now which you expect a decision going forward. So any clock is ongoing now or we're just rolling? And then my second question in the context of transparency going forward here. Can we expect UCB to inform the market here on if it receives another communication, whether that's Form 483 or any other request for additional information from the FDA?

Yes, 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 anyway close to an official communication. So really nothing, no new clock. It's UCB, in our huge accountability to be transparent to you, who has decided to communicate that we think no action in the next 4 days. And we believe if we look at the pace of the review at FDA that we have seen in the past, we will see actions during the third quarter. But there's no clock, it's our estimate based on past experience. And because we are going out of our way to be transparent to you, 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 are very, very serious about transparency and communication to you.

The next question comes from Stacy Ku with TD Cowen.

We have a few on BIMZELX and a few on RYSTIGGO. So if I could ask the previous questions differently, what gives you conviction that the BIMZELX approval make occur in Q3. The Form 483 feels very benign. But if we could explicitly ask, is there a need to reinspect the Braine facility? And then on RYSTIGGO, [indiscernible] 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 2-player market for FcRn in myasthenia gravis?

So again, with the commitment that will not release any details on the ongoing review no matter from which angle you asked the question, we'll just stay firm on our policy not to release any details of our ongoing review. There is -- yes, nothing to add at this stage, and we have been delivering, yes. Jean-Christophe, will you take the second part of the question?

I will. And 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 with very partial data. Imagine if we start to begin to answer your questions about how do we feel, what is the level of risk, how do we interpret, what are the different steps, what are the different potential activities that we are doing, then immediately 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. So to me, the best way to avoid these misinterpretations and false rumor and nonfact-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. And 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. And 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. But 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. So it's not that we are hiding information. It's more with the objective to be fair, disciplined and fair with everyone. Now on the second question that you had on RYSTIGGO. Yes, we -- I mean, we have been able to illustrate in the past our view on this market, in particular. And so just 2 or 3 quick points on that. Point number one, these patients are now eager to move towards more precision medicines after having the need to go to the hospitals on a regular base. So it's a major transformation for patients suffering from generalized myasthenia gravis. And it's great to see that there are different therapeutics, different products, different class also to better address the need of these patients. We are already in a very unique position because at the same time, we have an anti-FcRn. We target the ability of the body to recycle the IgG and to eliminate more IgG. So to do kind of a more natural IVIG or plasmapheresis' outcome. And at the same time, we have an anti C5 with zilucoplan that will provide more anti-inflammatory drug for these type of patients. And so we are able to cover the different need of the patients, the different patient types and phenotype. And you know, this disease is an autoimmune disease. So by nature, autoimmune disease are very diverse. Patients are very different one from the other. And so it's also illustrated by the type of IgG that create the disease. Sometimes it's anti-acetylcholine receptors, sometimes it's anti-MuSK receptor. So that gives you the level of diversity of these patients. So being the first anti-FcRn with these double indications or double type of patient population should give the physicians a huge relief that they don't have to think about what type of patients are in front of me, because basically, with one solution, they can provide a good answer in both cases, in the anti-acetylcholine and anti-MuSK positive receptors. And if you have seen the data, the data that we have on the anti-MuSK really very significant. So we are very pleased with that. And so 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.

We have time for one last question. If we do not have time to address your questions, please e-mail them to [email protected]. Our last question today comes from Charles Pitman with Barclays.

Maybe just on RYSTIGGO. Could you give us any guidance on what your pricing strategy is going to be here as you started this conversations with the regulator? And maybe just given your point about being in a new position with zilucoplan, how this could change upon a potential approval? And 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 '22. I was just wondering if you are happy to reiterate your confidence in where the market currently sits with this?

Thank you, Charles. So on the RYSTIGGO and zilucoplan, once again, the ability to get the 2 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 the 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. When 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. And as you know, we are not the first one in the marketplace. So we have some kind 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 treatments. And our objective for our patients is to be treated with the zilucoplan and have more or less the same level also of pricing, then ensure the control of the disease and with the other therapy. So we are not the first in the class in each of these categories. So we are looking at different framing of these categories, and we do not plan to be significantly different from a price per year to control the patient. Oh, sorry. And on the guidance, I think I guess there's nothing to add to that. We are -- we confirm the guidance from the company. We do not comment on the consensus or -- and we have not provided guidance specifically for BIMZELX outside of the U.S. or in the U.S. So we will communicate on that later on.

And maybe just a very quick cheeky follow-up. And when you said shift of weeks at the beginning of the call, can you confirm that, that means you think this is more like you took on early 3Q rather than late?

Sorry, can you repeat the question? I mean there was some connection issue.

Apologies. Just earlier in the call, you highlighted that this announced transparency relating to an expectation for an FDA action in 3Q was a shift of weeks. Can you just confirm that, that means whether it's likely to be -- to occur in earlier 3Q rather than later in 3Q based on your experience?

No, no. Sorry. Sorry, I just wanted to -- I just -- thank you for the clarification. What I meant was Q3.

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.