Ladies and gentlemen, welcome to the Lundbeck Conference Call. I'm Moritz, the call operator. I would like to remind you that all participants will be in a listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Charl van Zyl, President and CEO. Please go ahead, sir.
Good afternoon. Thank you again for joining, of course, our call today on very short notice. And we want to use this time together to engage with you on our definitive agreement that we've announced to acquire Longboard Pharmaceuticals. And of course, this is a significant step for us forward in our journey to become a focused innovator. But before we go to the more detailed points on the deal, let me go to the next slide, please. So, on this slide, again, I want to make you aware of the forward-looking statements. So, these include statements regarding the transaction between Lundbeck and Longboard, and of course, are subject to various risks and uncertainties and subject to change. If we can go to the next slide, please.
And before we then talk about the deal itself and the agreement we've reached, let me highlight a few of the following points. The tender offer is not yet commenced, and of course, this will, as highlighted in the press release. And this call is therefore only for informational purposes, and of course, neither an offer to purchase or solicitation to sell any of the shares or common stock of Longboard. I just wanted to make you aware of these points as we go into the next discussion about the deal. So, let's go to the next slide. And of course, I want to say again here that I'm really pleased that we could announce this deal today for Lundbeck to acquire Longboard Pharmaceuticals. And there are three and four important points that I want to highlight for you again around why we believe in this deal.
First of all, it's building on our future as a focused innovator in the space of neuroscience. And what this deal brings us is a real perspective on long-term growth for Lundbeck in the future and in the next decade. It really builds on our strategic ambition to build strength in the Neurorare space going forward. And of course, this complements other areas we have, like Amlinetug in an alpha-synuclein in MSA that is also part of that program in the Neurorare space. And of course, what is important in this asset that we are acquiring today, Bexicaserin, is that we are acquiring an asset with breakthrough therapy designation and the potential to address a number of severe and rare epilepsies in the space of developmental epileptic encephalopathies.
And the final point I want to make again is that this, based on what we know today, this asset and the programs that we will develop it in will have the ability to deliver peak sales in the range of $1.5 billion to 2 billion, and of course, complementing our existing mid-stage and late-stage pipeline and building therefore a strong position for long-term growth for Lundbeck. If we go to the next slide, what I would like to again emphasize, as you have heard from us many times and from myself, these are the pillars of our focused innovator strategy. The one is, of course, to grow what we have, grow in the midterm our strategic assets. And of course, we see very strong results there as we have communicated in the first half of this year.
And that, of course, continues to be a key focus of growing through the midterm with our existing strategic assets. We, of course, focus very much also on our capital allocation towards innovation for the long term. And this is where our deal today with the acquisition of Longboard fits very well. It fits into our focused innovation strategy to build sustainable growth for the long term. And what we bring into the pipeline now is an asset that is going into phase III, and phase III's trials are being initiated with the ability to launch in the Q4 of 2028. And of course, the final pillar that we will discuss in more detail also during our upcoming Capital Markets Event is, of course, our ability to also reallocate capital and fund that future in a very sustainable, profitable way.
So, if I then go to the next slide, just a few words on Lundbeck and Longboard. And I first want to take a moment to, of course, thank the Longboard employees. This is a tireless effort that this team has worked in advancing the science in this space and bringing this level of innovation into an area of very high unmet need. And so, I'm sure that the team is very proud of their achievements. And we, of course, are very grateful that we can now build on that legacy and bring this to patients in the future. So, what you have here is Bexigcitrin, which is a very selective 5-HT2C agonist with a broad potential. And we see that potential in areas like Dravet, Lennox-Gastaut, and of course, other rare developmental epileptic encephalopathies.
And so, this is an area where we see really a number of patient populations that can be addressed by this very selective mechanism. We have seen, of course, compelling phase II results that lead into phase III with also a breakthrough designation that is compelling in terms of its efficacy and safety profile that we believe could be a best-in-class treatment in this space. And of course, the fact that the phase III results were compelling, of course, also means scientifically that it's de-risked, and we have a high confidence that it will come to the market and, of course, will contribute to that $1.5 billion to 2 billion peak sales potential that we see across these multiple indications.
To now talk a bit more about the strategy and the strategic fit, I would like to hand over to Maria Alfaiate, who is our head of corporate and commercial strategy, who will share a bit more of her perspectives on the deal and the strategic fit for Lundbeck. Maria, over to you. Thank you.
Thank you very much, Charl, and as we have been, or as Charl has been mentioning, this acquisition showcases a perfect strategic alignment with our focused innovator strategy that we've been sharing with you for a while. It also showcases our ambition to continue to bring leading innovation to patients within neuropsychiatry and neurorare diseases. Charl has already alluded to the fact that this is a de-risked asset with several potential indications, with compelling evidence, convincing evidence of what could be potentially a best-in-class for Dravet and Lennox-Gastaut, but also first-in-class for other DEEs. The significant IP protection also gives us a considerable runway where we can drive the success of this asset. Of course, it has a strong fit with Lundbeck's strategy. It enhances our dedication to neurorare and also to the established presence that we have in neurorare epilepsies in the U.S..
We expect launching in Q4 2028, as already has been alluded to, and I would move on to the next slide, please. You've also seen from the press release that Longboard Pharmaceuticals has an interesting profile. They have been experts in this area, and with the initiation of the phase III DEUCE study evaluating Bexigcitrin in Dravet syndrome that is scheduled for this year, we will be playing into this rare epilepsies field, so on the asset you've read before, Bexigcitrin, we believe that this could be a best-in-class within the modality. We are going for a broad range of indications, many of those that are currently very underserved. This asset is in reality a pipeline in a product, and I will let Johan tell us a bit more about the profile of the asset itself.
Yeah, thank you very much, Maria. Let's turn to the next slide. So, before I go into some more preclinical and clinical details about Bexigcitrin, I'd like to sort of orient you a little bit in the indication space we're operating here. This is an anti-seizure medication intended to work in a certain group of epilepsy patients. Epilepsy, as you know, is a very, very broad category of diseases with still enormous unmet medical need. It's estimated that around 30%, between 25% and 40% of epilepsy patients are not really reaching any good therapeutic effect with the drugs that exist today. So, they are what we call resistant to seizure medication. If we look then in how we classify different epilepsies, we still work with the classification on how the onset of the seizures start. So, here we have the two different groups of focal and generalized seizures.
This is actually a fairly new classification in terms of epilepsy. We previously talked often about partial onset seizures when we talked about the focal seizures. But it really now recognizes the focal onset in, say, the temporal lobe and other more defined unilateral region for the focal seizures. The generalized are, as indicated by its name, something that broadly emanates from the whole brain, both sides of the brain. There are also mixed patterns of onset of seizures, and then, unfortunately, there are a number of unknown reasons for it. If we then drill down on the DE group, the developmental and epileptic encephalopathies, they can occur. The etiology of them are basically based on three different broad categories: acquired, syndromal, or genetic. The genetic ones are basically best illustrated by Dravet syndrome, where we have dominant mutations in the sodium channels.
When it comes to the acquired ones, they could be due to brain trauma, tumors, and other effects of the brain, like infections. While the syndromal ones come across a number of different syndromes that are metabolic or due to other causes. So, if we look at the DEE space, it contains a lot of different causes of epilepsies, seizure conditions. And it's only actually four of those that are today treated with any medication. So, it's a big sea of DEEs that are not reached today with approved therapies. Dravet syndrome, I just mentioned, that's a dominant mutation in sodium channels, primarily in this case. Here we have a number of drugs since several years back. Lennox-Gastaut is actually a more narrowed-down indication space than it used to be, and it's more defined now through its EEG recordings.
but it's also quite well served by its drugs, but still many, many patients that are not responding to treatment well. Tuberous Sclerosis Complex is an indication where we recently have brought a couple of drugs to the market, but it's still tremendously underserved. Then we also have seen new drugs in the CDKL5 or CDD disorder very recently. But as you can see on this list, which is just an example of the many different DEEs, there are many that are not served by approved drugs. Next slide, please. So then, if we look at the numbers of patients here, you have the approved therapies in darker blue here on the left side in the four indications I just mentioned. But as you can see, there are many other DEEs that are not served today by approved treatments.
That's approximately 100,000 patients today that are not served by any approved therapies. Bexigcitrin has the potential to address across all DEEs. That's why we're particularly interested in this drug. Next slide, please. Then, if we look a little bit at what made us very interested and excited about this drug, first of all, it has a very unique selectivity for 5-HT2C receptors. This is believed to be the validated receptor for its efficacy. The interesting thing about this selectivity here is that it's conveyed by a pretty well-understood structure-activity relationship. It's in the tricyclic structure with the amine group on the eighth position that really conveys that selectivity. The selectivity had also been seen by the major metabolites of the drug, which is very important to also look at.
This means that this drug avoids some of the in-built liabilities you see with 5-HT2B or 5-HT2C agonistic properties. Through that selectivity, it doesn't have any major in-built liabilities to have any of those cardiovascular valvular pathology liabilities or psychiatric-type psychosis liabilities that may occur also with 2A agonistic approaches. The preclinical evidence is pretty standard. There are a number of animal models that have looked at this, and it showed good efficacy across a number of models. That, of course, triggered a clinical development program in the phase I program that looked at the safety, food interactions, and drug interactions, which are very important because patients are often on the multi-drug therapies, polydrug therapies. It's very important to see that it doesn't interfere with standard of care.
Built on this, a PACIFIC study was done, which was a phase Ib/IIa proof-of-concept study with multiple DEE populations. And the top-line data were communicated early this year. And that triggered, of course, our interest. And it was well recognized by the scientific community as well. And this also triggered the company Longboard to continue with initiating a phase III program. There is also an open-label part of this PACIFIC study that has been quite recently reported. So, I'd like to drill down a little bit more on the results of the specific trials. But if you go to the next slide, please. So, on the left side here, you see from the PACIFIC study the overall effect of Bexigcitrin in reducing the countable motor seizures.
So, here we're looking at one type of readout, which is the most clinically relevant when you look at motor-induced seizures, basically epilepsy that leads to motor effects. And here you see a quite pronounced effect against placebo. And I like to call out that placebo here are patients on standard of care. So, on the overall population, we see almost a 60% reduction in the countable motor seizures versus 17% in the placebo-treated standard of care patients. If one then looks a little further at the different subpopulations, and this was a mixed group study, so obviously, it varies a little bit how many patients that were included in the various subgroups. But I think this is very interesting to look at because if you look at the bigger group, Lennox-Gastaut, it was still a very robust over 50% reduction of the countable motor seizures.
And in other DEEs, where quite a sizable group of patients was included, there was a 65%, almost 66% increase in the countable motor seizures. And then, interestingly, in the smaller set of Dravet patients that were involved, this was a very pronounced reduction of the countable motor seizures. So, this, of course, is very encouraging data, and it's the basis, of course, for the initiated phase III program. It also interested the FDA because the company has obtained a breakthrough therapy designation on July 1st for DEEs for patients at two years or older age. So, with this, I'd like to hand over to Jörg with the next slide.
Thank you, Johan. This is truly a transformative and value-creating acquisition accelerating our strategy to become a focused innovator. From a transaction details perspective, we're talking about a purchase price of $60 per share in the form of an all-cash transaction. The $60 per share constitute a 54% premium to the closing price of Longboard Pharmaceuticals as of last Friday, October 11. The total consideration for this transaction amounts to $2.5 billion net of cash, which is approximately DKK 17 billion, thereby making it the biggest deal in Lundbeck's history. We fund this transaction basically through existing cash resources and existing committed credit facilities. We see this transaction carrying deep value for Lundbeck and believe Bexigcitrin is a de-risked asset with compelling phase II data from its specific study.
The phase III DEUCE program has been initiated last month, and Bexigcitrin has an opportunity for a series of indications supporting continued growth due to its unique pharmacological profile that can deliver an unprecedented efficacy and safety profile across the DE patient population. We estimate peak sales potential between $1.5 billion to 2 billion. And the Longboard acquisition will significantly bolster our late-stage pipeline and drive growth through the next decade. We expect closing for this transaction in December 2024, and we expect to recognize integration costs in the amount of approximately $80 million, which amounts to roughly DKK 550 million, which predominantly will impact 2024 and will be adjusted for in our adjusted EBITDA financial reporting. As a result, we do not see an impact to our full year 2024 adjusted EBITDA guidance.
This transaction is, of course, also attractive from an EBITDA accretion perspective that we estimate to be two to three years after launch in Q4 2028. Bexigcitrin, together with other programs in our current portfolio, such as Anti-PACAP, Amlinetug, and Anti-ACTH, complements Lundbeck's long-term growth potential while addressing the LOE of Rexulti at the same time. From a capital allocation perspective, we do not see any significant impact to our priorities. We remain committed to our dividend policy, targeting a payout at the existing 30% range of net profit, as well as the maintenance of an investment grade rating at all times. Even though this is a very sizable deal for Lundbeck, we still have capacity for additional BD from a debt perspective, in line with our focused innovator strategy.
On all of these topics, we will elaborate further at our capital market event on October 23rd next week. With that, I will hand over to Charl for some closing remarks.
Yeah, thank you, Jörg. And if we can go to the final slide before I invite you for questions, let me just leave you with the key points. Again, it, of course, reinforces our strong position in neuroscience as a focused innovator. With this acquisition, it really perfectly fits into that strategy and contributes significantly to our long-term growth perspective. We see an adequate risk profile, in fact, scientifically quite de-risked as a late-stage asset with multiple indication opportunities. It really builds depth and strength in our neuro rare portfolio as one of our key pillars we want to continue to build as a future option for Lundbeck. And, of course, as Jörg had mentioned also here, strong, solid balance sheet here, also post-transaction. So, with that, I would like us now to go to questions and open up back to the operator. Thank you.
Ladies and gentlemen, we will now begin the Q&A session . Anyone who wishes to ask a question may press star and one on their telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode while asking questions. Anyone who has a question may press star and one at this time. One moment for the first question, please. And the first question comes from James Gordon from JP Morgan. Please go ahead. Mr. Gordon, your line is open now. Seems like he may have issues with his microphone. Then we will go to the next question, which comes from Charles Pitman-King from Barclays. Please go ahead.
Hi, guys. Thanks very much for taking my questions too from me, if I may. Just to get us started, could you just give us, Johan, maybe a little bit more information around how we should be thinking about current standard of care for these rare epilepsies and how the competitive environment has developed over time and why particularly Bexigcitrin is well placed to kind of beat these out? I mean, where in the treatment paradigm should we really be expecting it to place? And then just secondly, a question in terms of the kind of premium suggested to be being paid for this asset. What is it about this asset that makes the kind of roughly 80% premium seem appropriate? Is this the level that we should be expecting for valuations of focused innovative biotech deals that you'd be looking to do in the future?
Thank you very much.
Yeah, so I can start with your first question then. And thanks. It's a really good question. And obviously, we think it has a pretty unique space in the armamentarium of standard of care because it's profiled, the binding profile, et cetera, of this molecule. But if I walk you through a little bit more what we have in terms of competition, there is no drug approved for this broader label of DE. And what one would be aiming for here is an indication for DE, basically, for children about two years or something of age. That would be a very encompassing indication label. If you look at the specific different diseases, of course, Dravet has had a number of drugs on the market for many years. Epidiolex is there since 2018, and Fenfluramine also came in 2020. So there are some pretty efficacious medications out there.
But the little data we have so far on the molecule in Dravet syndrome indicates that it has, if you eyeball the results, a very impressive reduction of the motor seizures. So that's why we hope to see more data. And the company, Longboard, has already initiated a phase III trial in Dravet syndrome. When it comes to the other big indication in this space, sub-indication in this space in LGS, there are probably about eight approved drugs. And you have also drugs like Fenfluramine there and cannabidiol. So those drugs are active also in that space. Fenfluramine got approval quite recently in 2022. So here we have an efficacy that also definitely works against those drugs at a similar level, if not better. What we like to see here is, of course, more data.
And also with the differentiation here that I hope will play out very much in the eyes of the prescribers and the patients and caregivers is the broader safety profile that this drug should entail by its selective 5-HT2C agonistic effect and avoiding the 2B. For TSC, which is a little odd indication in this big family, there are a couple of approved drugs. In 2020, Epidiolex again, and then a new drug that came, an mTOR inhibitor in 2018, which came through treatment of other tumor effects. And then the CDD indication has, as I mentioned, a new drug. I think overall, this biggest potential of this is that here you don't have to really look at the subsegments. And here you offer a therapy that actually can work across any kind of DE, some of them very, very rare.
And that is what we intend to do in the coming trials that start up for phase III. So then I hand over to Charl maybe to handle the next part of the question.
I can take that first, I think, Charles, to come back to your question. I think we're talking about an attractive acquisition price, which is below, you can say, factor 1.5 of expected peak sales. If you compare that with precedent M&A transactions somewhere in the range of $1 billion to 5 billion post-POC data and pre-phase III data, then it's very much in line with, from a premium perspective, whether you look at unaffected 52-week high or 30-day VWAP, and it is actually even more attractive if you compare it to some of the precedent rare epilepsy transactions.
But besides multiples, I think it's much more important at the same time to look at the, as Johan said, the de-risked nature of the asset and the quality of the commercial case that we have been able to put together, which sits on the back of achieving a broad label and is, of course, work out of a very diligent due diligence we have done together with Longboard pretty much, you can say, since January of this year, so it is a strong drill down into expectations we have on expected price, market share, launch, and LOE in 2041.
Thank you so much.
The next question comes from Xian Deng from UBS. Please go ahead.
Hi, thank you. Thank you for taking my questions. Two, please. I guess the first one for Johan, please. On slide 12, so that p-value of that phase II trial is actually crosses the threshold of 5%, yet the magnitude seems to actually be very big for the active arm. So just wondering, why is that the case? Is that just multiple diseases, or is it just high variance with individual patients? And how does it translate to your expectation for the phase III, your degree of confidence of phase III success? That's the first question, please. And the second one, just sort of wondering, level of confidence of achieving that peak sales of $1.5 billion to 2 billion? Because if I look at the Fintepla, the consensus kind of with several sort of similar overlapping indications, the Fintepla consensus is actually around, is actually below EUR 1 billion.
So just wondering, given your expectations a lot higher, given the very similar mechanism, but just wondering, do you think your confidence is actually from, you think you're going to have more indications, or you think you actually have a better drug, so you will have more market share? Thank you very much.
Yeah, thanks very much for that good question. Yeah, so if you look at the PACIFIC study, obviously, it was a proof of concept study, much smaller, and it didn't include so many Dravet patients, just a handful, less than a handful. So the bigger population, as I mentioned, the focus was Lennox-Gastaut syndrome and other DEEs, including a reasonable subset of other DEEs group, but they obviously covered many different sub-indications here.
I think the confidence we have really of going into phase III is that it was consistently shown across the population to work. Remember, this is still a fairly small proof of concept study, so p-values are not really the critical aspect here. It's really the extent of effect and the variability you see almost at an individual level. So even in the few patients that were included from the Dravet subgroup, there was a very consistent effect.
Now one needs to look, particularly in the Dravet group, at the bigger population, and that's really what has been initiated now. I have to say, I have a very strong confidence that this will work out very nicely across populations. And why is that? Well, first of all, hidden in this drug is a validated mechanism, the 5-HT2C agonistic effect, while this is a super agonistic effect. So if anything, more potent, it's a very potent drug on that receptor with a remarkable selectivity. So there is no inbuilt sort of brake in dosing here. Physicians and us in clinical trials shouldn't be really concerned about liabilities inbuilt in the molecule.
So that's one aspect that I think is really very interesting with this molecule because other drugs have a little more troubling side effects or even REMS programs that try to avoid problems with other side effects that could occur, like also what has been described with, for example, Fenfluramine with the 5-HT2B liability. It took many years for that drug to build up its dosing and go into this indication space. Here, we don't have that concern. One could go straight out and really test the drug at reasonable doses. I hope that answered your question.
Yes, thank you very much. Very helpful.
The next question comes from Martin Parkhøi from SEB. Please go ahead.
Yes, Martin Parkhøi from SEB. Just a couple of questions. Firstly, just on your potential for initial launching in the Q4 of 2028, would that be on the broad use, or do you need to get a single indication in the beginning and then you get add-on indications like we are seeing and hopefully we continue to see on Rexulti? And then just secondly, do you have any interest on other parts of the pipeline of Longboard, or is this just a single asset acquisition? And in this context, was a license in the deal or a single asset sale, was that on the table as well, or was it a full acquisition which was necessary? And then finally, to Jörg, how would the additional R&D cost that you'll take in, how would it impact your midterm margin targets?
Yeah, maybe I can start, and then maybe if others can fill in a little bit. Yeah, so first of all, I think it's very important to note that the breakthrough designation that FDA has provided here is really for DEEs, unspecified in some sense. So that is, of course, the label one would aim for. So that would encompass, of course, Lennox-Gastaut and Dravet and tuberous sclerosis or whatever one may have in the trial. We really are going to aim for that sort of, what you say, broader label initially. So there is no slicing here. The idea is really to encompass the whole DEE population. Obviously, there are various variants of this, and the way you run the trials could lead up to various sub-indications also being labeled or at least mentioned because those populations are studied in the clinical section of a label.
Other pipeline assets, yes, there is one S1P modulator that is in phase I. That is an asset that I would say is not any driver at all for this deal. This is a compound that is on a mechanism that is, quite frankly, also validated, Gilenya and other drugs. But it's a very late comer, and this is something we didn't include in our evaluation of this deal, really. I hope that answered parts of your questions, but I think there could be also other parts that others can answer.
I can add, Martin, to your question around what type of deal structure was available. Of course, many of these are considered if it's in licensing or outright acquisition. Of course, it depends also on the seller, and in this case, it was an outright acquisition that was really the deal structure on the table. Jörg, you want to comment?
I'm happy to comment on the midterm targets. I think we feel comfortable to be able to handle this within the, you can say, existing bottom line range or margin targets we have given. Of course, R&D costs are going to increase, but that's also not something new. We've seen that also this year, and that's also in line with our long-term guidance, so that should be clear.
Can I just have a follow-on to Jörg? Maybe the peak sales estimate of $1.5 billion to 2 billion, how is that regionally stood?
I think it's.
Broadly.
I think it's very fair to say that the U.S. has more than a super majority in this case.
Thank you. Congratulations.
Thank you.
And the next question comes from Manos Mastorakis from Deutsche Bank. Please go ahead.
Hello, thank you very much. Looking at the Longboard's history and prior ownership, is there anything you can share about royalties, any royalties owed to other partners in the past? And second question would be on general confidence you have in the approval, is the deal still going ahead and antitrust approvals, if you can comment on this point. Thank you.
Yeah, Manos, it was quite difficult to get your question. It was not a very clear line. I think your question was around prior ownership and royalty commitments. We don't see any of those of concern for us in terms of our deal structure. I couldn't get the second part of your question very well. Could you maybe repeat if possible?
Yeah, just tell me about the confidence in the deal going ahead, any antitrust approvals, and then just how do you think about that? Thank you.
Yeah, thank you. So I think your question is around antitrust, if I understood correctly. And currently, our working assumption is by the Q4 of this year, we should expect clearance.
Thank you.
The next question comes from Marc Goodman from Leerink Partners. Please go ahead.
Hi, this is Madhu Kumar for Marc. We were just wondering, could you talk about the potential for the full DEE label outside of the U.S.? Maybe what you know the EMA's view of this is since you're going after the full label directly in the U.S.? And then the second question is, you alluded to the pipeline and the product. Are there any indications beyond epilepsy where this mechanism could make sense? And given the superior selectivity and potentially better safety of this type of asset, we were just wondering if there's any indications in your mind beyond the DEEs that are already highlighted. Thank you.
Yeah, I guess those are two questions for me. So let me try with the last question first. I think this is a pretty unique mechanism for seizure conditions. We have not considered any other indications. Of course, there are conditions that come with seizures. Famous is, for example, Alzheimer's disease, where you have seizures at some stages. So one could perceive maybe other indications, but there will still be some type of anti-seizure medication. So we're not going outside the anti-seizure medication space with this mechanism, to my knowledge. I mean, things can happen in the science field, and you remember this is a very old serotonin mechanism, really, if you think about it. But we don't expect anything else.
When it comes to the DEE indication, which is really an interesting and I think quite exciting opportunity now presented by the breakthrough designation, we are aware about Longboard having had some conversations outside the U.S., but they obviously, as a fairly small enterprise located in the U.S., have been focusing on the U.S. regulatory interactions first. But there have been some initial conversations also with, for example, Europe, and we understand that so far it's been reasonable and encouraging conversations.
But we really need to get under the hood with this and really try to pursue our own avenue with the regulatory interactions with Europe and Asian major markets to really understand the potential. I think this is a really great. I like the comment. I think this is a very great opening by the FDA because it really follows where the different organizations in the epilepsy space are working.
The International League Against Epilepsy has really adopted DEE as a broader category, and I think the FDA seems very responsive to that kind of new label.
Thank you.
Ladies and gentlemen, as a reminder, anyone who wishes to ask a question may press star and one at this time. And the next question comes from Carsten Lønborg Madsen from Danske Bank. Please go ahead.
Yeah, thank you very much. I just had one question. Maybe you could outline a little bit about the phase III trial design and whether this single phase III trial is enough to get you to this $1.5 billion to 2 billion in peak sales that you are hoping for, or whether you need to add more trials over the years, also maybe in order for us to understand a little bit more whether this DEE indication can be captured in just one single trial.
Yeah, I can start the peak sales part. Maybe someone else can comment on, but let me comment on the phase III designs here a little bit. The initiated phase III program here actually is constructed with two different trials. So there is one trial that is looking at Dravet in it by itself, and then another trial that's just about to start up that looks at Lennox-Gastaut and other DEEs. So more a bundled basket type of trial. So there will be two trials within the DEE universe that will be run. This is probably more for practical reasons, etc., and how you enroll and what kind of balance you like to have between different types of causes of DEE. But the overall intent here is that this will be bundled together according to International League Against Epilepsy definition of DEE that emerged in 2017.
So it will fulfill sort of what we see within the DEE space. Obviously, there are literally hundreds, if not thousands, causes of DEE, but the trial is really trying to capture the major parts of causes for DEE from the different buckets that I talked about, acquired, syndromic, or genetic. So the intent is really to have a design that encompasses all and de-risk to get into all those indications. If that would not be the case, there is still a very strong mechanism of action so one can even slice the cake in different ways moving forward. In terms of peak phase, etc., I think someone else should comment on this.
Maria, please go ahead.
I mean, it links a little bit to the previous question as well. The global market for DEEs was valued at roughly $7 billion in 2023, and we expect it to jump to roughly $11.4 billion by 2033. So this is an annual growth of 5%. So this is indeed an area where we could have a significant impact. And I don't know if you want to supplement, Charles.
No, I think just to add for clarification for Carsten, our current peak sales potential that we have addressed, of course, today is dependent on us achieving that broad label. Just to be very clear on that.
Yeah, all right. Makes sense. Thank you.
We do have one follow-up question from Charles Pitman-King from Barclays. Please go ahead.
Thanks very much for taking follow-up. Just to double-check, in terms of this aim to get the broad label, obviously, there are other assets approved in some of these DEEs. What's been preventing them from achieving this broad label? Is this something that you and Longboard have been pioneering, and just what is the view of the regulator around this trial setup? Thank you.
Yeah, that's a good question, I have to say. And I don't see it in the heads of other people that have been looking at this space, but I have, in my past career, worked on resinamide, one of the early Lennox-Gastaut drugs. I think the main reason for this is, quite frankly, that this has been an evolving field, and we get much, much better definitions of the different subtypes, but also DEE as an entity by itself. It's quite recent, as I said, that we really defined the developmental and epileptic encephalopathies in 2017. So I think most programs didn't really have that kind of classification to work with when they started up. Would they be able to move into this space?
I think when you have the other indications, then it's a little harder because then you have to really study those specific populations to add them into it. Here we have a program that adds for that new definition in a broader sense from the beginning. So that creates a better opportunity to really get that broader label. Yeah, we don't talk so much about this in the industry, but there is, of course, a lot of off-label use and various indications here. I think what the world should hopefully look forward to here is a characterized on-label and verified working drug on the DEE population according to the modern criteria. I hope that answers the question because I think it's a really important question.
Thank you so much.
It does.
The next question comes from Sean Hammer from Jefferies. Please go ahead.
Two for me, please. So firstly, how will Bexigcitrin fit into the current commercial infrastructure given the prior epilepsy franchises off-patent? And then also, is there any scope for earlier commercial launch, so prior to Q4 28? Thank you.
So as we have mentioned before, this asset is fully aligned with our ambition to become a significant player in the Neurorare space. And of course, you know of our own internal asset, Amlinetug. So we are considering different types of synergies with commercial footprint with regards to the way we approach these Neurorare indications. I cannot give you too much detail at this stage. With regards to an earlier launch, of course, we need to see we need to monitor how the trial is going. Having breakthrough designation for these DEEs is a sign of interest from the FDA, but breakthrough designation does not mean necessarily that we will conclude the trial earlier than expected. It's just a situation that we need to look into, as with any other event-driven trial. I don't know if you want to supplement, Johan.
Yeah, I mean, yeah, I would love to have an early commercial launch, but you need to generate the data, and you need to get the patients into the trials, I should say, because they are separated into two trials here. I think it's really very hard to estimate at this early stage. These populations are really, really challenging populations. Remember, they are young, young children, many of them. They are born with encephalopathies that develop into seizures or born with both running in parallel, so basically comorbidities. They have cognitive and developmental problems. So for caregivers, it's hard also sometimes to participate in trials. But we hope that the encouraging initial data here will trigger patients to come into the trials. But in terms of reaching the DEE population or actually any of those populations, I think one needs to run the trials for a couple of years.
Ladies and gentlemen, this was the last question. I would now like to turn the conference back over to Charl van Zyl for any closing remarks.
Yes, so again, thank you so much for joining the call today. Of course, a very important moment for Lundbeck in our focus innovative strategy, and of course, very pleased to be able to announce this important transformative acquisition for us going forward. And we, of course, look forward to engaging with you more in our Capital Markets Event that will be next week, the 23rd of October. So looking forward to further questions that you may have at that point. Thanks again for joining today.