Newron Pharmaceuticals S.p.A. (NWRN) Earnings Call Transcript & Summary

Ladies and gentlemen, welcome to the 2022 Results and 2023 Outlook Presentation Conference Call and Live Webcast. I'm Andre, the Chorus Call operator. [Operator Instructions]. The conference is being recorded. [Operator Instructions]. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Stefan Weber, CEO of Newron. Please go ahead, sir.

Thank you, Andre, and welcome, everybody. Good afternoon, good morning to our listeners in the United States. It's good to be back for the third time already in what seems to turn into a pretty busy year for Newron, and so for all good news. So let's keep it like that. I hope you have been able to download the deck or you have succeeded in subscribing to the webcast, and you see the slides online. I'm here today with Ravi Anand, our Chief Medical Officer; Roberto Galli, the Vice President of Finance; and Dennis Dionne, Vice President, Commercial. Ravi and Roberto will share part of the presentation, and Dennis will be with us for the Q&A session. Now given that we did just present a few weeks ago, the very exciting 6 months results with Evenamide in treatment-resistant schizophrenia. And then a few weeks later, the 12 months results. We discussed if we should today go again into all the detailed results, and we decided not to. So we will present to you a summary, but we have all the detailed results as a backup. So if you wish to review those results or ask questions on those results and walk through those results, please tell us in the Q&A section, and we'll be happy to go back to that. So Newron is all about CNS development of innovative treatments and improve the quality of life. We are Milan, Italy headquartered. We have a subsidiary in Morristown, New Jersey. We are listed on the Swiss Stock Exchange since 2006, as well as the Düsseldorf Exchange and our shares are traded on the German, et cetera. That is why I would ask you to please read the disclaimer on Slide 2 carefully. We were looking for a title again for the last 12 months, and we thought that turning the tide was the appropriate title this time because really, what we are doing with evenamide is now we are opening a new book or writing a new book, at least we are opening a new chapter to evenamide because what we are doing is we are presenting to you for the first time, results from evenamide in patients with treatment-resistant schizophrenia. We presented to you striking interim efficacy and safety results from that Phase II study with evenamide as an add-on therapy for patients with TRS after 6 weeks and January and February, 6 months and 1 year. Interesting and striking, what we saw was that the addition of evenamide at 3 doses, 7.5, 15 and 30-milligram BID did result in compelling significant meaningful improvement in assessment of symptoms of psychosis disease severity and global evaluation. It didn't matter if it was PANSS total, CGI-S, CGI and the level of functioning, whatever we looked at results were significant. And more importantly, even they increased and improved from 6 weeks to 6 months and from 6 months to 1 year. The results for 6 weeks have already been presented in Taipei, Taiwan last year, CINP. And the full results for the 6 months will be presented at the ECP in March, still this year or next week and SIRS in May. What we can tell you is that not only now, given that we presented to you so far only the interim results for the first 100 patients, but also the full study population, 161 patient enrollment has been completed. And the full study results will be available later this month. So effectively within the next 2 weeks. So please stay tuned. It's very important news to come. We would be very excited if we could confirm the efficacy of the endpoints in the full population of 161 patients compared to the 100 from the interim analysis. What we have shared with the markets on top is that evenamide is a very safe drug. So safety data represented at CINP, of more than 400 patients, we can update you such that in the meantime, we are reached for 500 patients. As a consequence of those exciting news from the first study with evenamide in patients with TRS, we have decided that we will move ahead without delay to Study 003, which will be a potentially pivotal multinational randomized double-blind 10-week placebo-controlled study assessing the efficacy, safety and tolerability of 15 and 30 milligrams of evenamide as an add-on treatment patients with TRS. We expect this study to still start in 2023 this year. But this will be the second pivotal study of 2 that it needs to file for approval. The first one, as you remember, Study 8A is already ongoing. We are enrolling actively patients and we expect results from that study to come again this year. And in order to have the pivotal study in TRS patients, we completed in a good manner, we will look into a partnering transaction later this year. Moving to Slide 6 on XADAGO. You know that we have seen some Paragraph IV Notice Letters being filed against our patents, which go until 2031. We have filed protective action with our partners Zambon and Supernus. And we are in very good mood when it comes to the procedure. As you know, this is a lengthy procedure, but we have no doubt that in the end, we should prevail in that defense for our patents. On the corporate level, we have developed an ESG strategy. For the first time, we went for a strategic approach. We did not just do some here in their activities on the environment, social and governance. But we did a real strategic analysis, we identified focus areas, we identified objectives for this year. And our reporting, starting with this annual report from this morning, will be based on 10 out of the 17 sustainable development goals by United Nations. Filippo Moriggia has been appointed Vice President of Operations this year. He has been with us for a number of years. He has taken on additional responsibility almost year-by-year. So we are very proud to present him to you as part of the management team. And we are as we have been in the past, evaluating a number of pipeline opportunities to expand CNS pipeline with the opportunity to build value and to sell compounds ourselves in some niche indications on some parts of the world at least. Into Slide 7, the company highlights. You know that our leading drug, XADAGO is on the market now for 7 years in Europe and 5 years in the United States. What we can say is it is a very safe drug, and it is efficacious, obviously. And that speaks for drugs with that matters of action, we're talking about glutamatergic drugs and evenamide is one of those drugs. We have taken them out of the usual indication for voltage-gated sodium channel blockers and that would be epilepsy. We have developed in Parkinson's disease and in schizophrenia and in both indications of our compounds are absolutely unique. The management team has taken drugs to the market before and is taking XADAGO to the market, and we are very confident that also our next compound, evenamide will reach the market in the next few years. We have massive news flow to come this year, at least 4 more announcements on evenamide, and we have the cash to make it to mid-next year beyond all the inflection points from the ongoing studies. So let us move to Slide 8, and let's look at the differentiation of evenamide in schizophrenia. You know that this is a large market. We are talking about 1% of the global population where we refer, but we have 2 kinds of issues here, all the drugs on the market work by the same mechanism of action. And therefore, they all do the same. And what we need for about 70% of the patients who wants a few years into the disease, we'll have to switch medication about every 18 months on average is another response and that is an add-on drug in our case. So by adding evenamide to the current antipsychotics, we can change nonresponders and to responders. We do not have to change the current medication. There's no risk of relapse and hospitalization. And therefore, the risk for the patient and the doctor is minimized. It's ease of use for patients and physicians. And the second group that is urgently needing some support with those patients who are treatment resistant. Strictly speaking, that is about 30% of patients. But any doctor we are talking to says that he could at any time, qualify up to 50% of his patients to be treatment resistant. So there's an overlap here. Importantly, for that patient population, there's only clozapine with all the good and the bad. But as a matter of fact, 90% of patients in the U.S. were treatment resistant with not clozapine, and the same number here was 80%. What do we have to show to you? We already have positive results from Phase II in non-TRS patients. In that indication, the first pivotal study is already ongoing. We do have the pilot study results in treatment-resistant patients with 6 weeks, 6 months and 12 months interim results presented and the full results of the 161 patients at 6 weeks coming to the next weeks. This drug could be approved in TRS based on only 1 pivotal study with a chance for an early market access, that means we could be on the market even before the drug is formally approved. We have long exclusivity the composition of Midas 2033, so 11 years. And in the European Union, we will have 10 years exclusivity post approval of the drug in the European Union. That all said, I hand over to Ravi Anand. Ravi, we are moving to Slide 9.

Thank you, Stefan. Good morning and good afternoon to folks in the U.S. and in Europe. I think Stefan has already talked a little bit about schizophrenia. So I'm not going to repeat it. We all know that this is probably the most malignant of the CNS conditions. I call it malignant because the onset is already at the age of about 16, 18, 20 and 25 in the case of females. And unlike what is said in the literature, the disease does not burn out. Patients will still continue to take medication till the time they're in the 70s. So it's a very long period of time during which the patient cannot lead a fruitful life. The families affected, everybody's affected. The worldwide, the prevalence is around 1% of the disease, of all patients, and the cost to society is enormous. If you just look at direct costs and only for the U.S. alone, that's over $63 billion. Now the problem with schizophrenia is now that there is no treatment. There are lots of treatments. Unfortunately, most of these treatments are all modeled of the same mechanism, which is basically modulation of D2 receptors. Could be directly, could be indirectly, could be with serotonin, could be without serotonin, could be with D1 also, could it be D4 also, could be with alpha receptors. But ultimately, what produces antipsychotic efficacy appears to be dopamine blockade. This dopamine blockade seems to work in some of the patients for some of the time. But unfortunately, there are about at least 30% of the patients who will not respond to dopamine blockade. About 80%, 90% of these patients who become treatment resistant. And actually resistant to dopamine blockade right from the time they have the first episode of schizophrenia in the early teen years -- late teen years, some patients become resistant over time. The problem with the current antipsychotics is that since they modulate only dopaminergic and monoaminergic systems, they cannot help these patients because their disease is not because of monoaminergic problems, it's because it appears to be linked largely to glutamate disfunction. Glutamate is ubiquitous in the plan. It has got a lot of housekeeping functions, and any abnormalities in glutamate transmission affect patients' behavior cognition profoundly. If you could go to the next slide, please. We decided to develop evenamide not because of the market opportunity. Because its preclinical profile appeared to be something which was completely unique. It's a sodium channel blocker but it doesn't affect any other neurotransmitter system. It only uniquely normalizes excessive release of glutamate, why is that important? Because excessive release of glutamate has been linked to all kinds of CNS problems affecting transmission, positive symptoms, negative symptoms, cognition and furthermore, synaptic efficacy. We also realized that most patients derive some small benefit from the current 5-HT2/D2. So rather than go it alone as monotherapy in these patients, we decided to check what is efficacy would be if you go to add it to the existing drugs. Therefore, taking advantage of the mesolimbic and mesocortical dopamine blockade. And adding to that, the unique properties of glutamate release inhibition and reduction of firing. So we decided on 2 patient populations, basically. The first would be patients who are not treatment-resistant, but they're beginning to lose their response. They're no longer responding as well as they used to. This is what we call as inadequately responding patients. The vast majority of patients with schizophrenia are in this category. Here, what you need is a drug which could be added to the existing medication without any additional liability. The second population will be the treatment-resistant patients. Unfortunately, for this patient population, other than clozapine, which is barely used, there is no breakthrough at all. What happens currently is patients are treated with a concoction of drugs, which have no basis for efficacy. But the value that we would derive is that we will be providing a mechanistic answer to the problem of schizophrenia. And therefore, it's likely to be very well supported in terms of pharmacoeconomics and health technology assessments. But let me talk about a subpopulation of the treatment-resistant patients. That is the patients who are in clozapine, that's only, as I said, only 30% that are qualified for that. And barely 5% to 10% whoever using it, depending upon the country. The maximum use would be in Europe would be about 17%. But out of these clozapine patients, less than 30% are full responders, and 30% derives no benefit. And of those 30 patients, 30% of the patients, the addition of evenamide to clozapine in all the animal models that we have done seems to confirm benefit. So this could be a unique population. It's more like an orphan-like population, but we will be able to capitalize on the small population and even market the drug ourselves. If you go to the next slide. Just to very briefly give you the summary of safety to the state. We are actually close to now 500 subjects that we have treated, unique subjects with evenamide. We have treated healthy volunteers up to doses of 60 milligrams single dose patients, 30-milligram BID. We have gone up to 1 year and past 1 year of treatment, very few dropouts due to adverse events. And if I look at the adverse event column, the ones that have reported, headache, dizziness, abdominal pain and discomfort, actually, the incidence is the same as in placebo. We don't really see any difference in this at this moment. I'm sure by the time we have 3,000 patients, we will see some difference. But at the present moment, there is really nothing. The completion rate in the trials is extremely high as I will show you in the next few slides. So currently, we have actually by now more than 150 patients who are ongoing in different trials. If you go to the next slide, please. This is the first study that we did with this compound. We're at this stage when we did not have much data. This was a study, a 4-week study done under the IND in the U.S. and in India. Where we added this drug to patients on risperidone and aripiprazole, who had responded in the past, but now are beginning to lose their response. What we realize is that the moment we added this drug at the very first assessment at day 8, when the patients were on 15 milligram, we could see a significant improvement in terms of PANSS positive symptoms, mean change, responder rate, the clinical global impression of change. And since a small study, so not everything could be significant because the sample size is so small. But virtually every efficacy measure showed to be in favor of treatment compared to placebo. And placebo here with aripiprazole or risperidone. So this was sort of a proof of concept for us that the glutamatergic mechanism of action appears to work in this patient population. And this led us to further advancement. Next slide, please, which is to interact with the regulatory authorities. We have shared the data to the state. And basically, whether it be in EU, where we have met with Spanish, Danish, Swedish, German, U.K., CHMP. And in the U.S., we also met also in Canada authorities, all on an agreement on the Phase III plan. Basically, the Phase III plan will be -- basically, we will pursue 2 indications I've talked about before. But before that, we had the requirement to do some preclinical work, which has been done. We needed to do some clinical safety work, which has been done and submitted to FDA and to all the health authorities. And basically, we are now at the stage where the data from the treatment resistance study we will be submitting to the FDA to start the Phase III program. Next slide. So in the Phase II treatment resistant study. This has been a revolution. This was a pilot study, which we did really for looking at safety and tolerability because nobody in the world has ever treated treatment-resistant patients with a glutamate release inhibitor. It was anxiety that this could actually worsen patients. So we were very, very cautious. We initially started the study only at 2 doses, which is 7.5 and 15. Only when they were well tolerated after discussing with the safety monitoring board, we added a 30-milligram BID dose. Overall, we completed the study with 161 patients randomized. And the primary efficacy measure, as in all efficacy trials or the PANSS total score. What we see is a very high completion rate. 97 of the first 100 patients randomized when we had analyzed completed 6 weeks of treatment. The usual dropout rate is around 30%. Of the 97 who completed offered a chance to continue, 90 of the 97 chose to continue treatment. Despite the ongoing COVID, despite the numerous requirement for visits, et cetera. Usually, 30% to 50% of patients decline to continue an extension. Out of these 90 patients, 85 of the 90 completed 6 months of treatment. Again, a very high completion rate. Usually, by this time, we have about 40% to 50% of patients having had dropped out. And out of these 85, 77 completed 12 months of treatment. In fact, I could even tell you that as of today, we are now filing amendments to allow these patients to continue beyond 1 year. They still want to continue with treatment. That tells us 2 things. First, the drug must be well tolerated because no schizophrenic patient is going to remain on drug if they're not tolerating it. Secondly, caregivers must be seeing some benefit. Otherwise, they would not have continued. We now have analyzed all 161 patients who have been treated for 6 weeks, and the results will probably be released next week or so and final results up to 1 year of the 161 patients would come next year. Next slide, please. What did we find from the study? I mean, I'm not going to go through all the data since we just recently reviewed it, but these slides are available, as Stefan has mentioned. First of all, unlike conventional wisdom. What we found was that patients not only tolerated the drug given for 1 year, but a very high number completed without any evidence of any causally related safety issue. Looking at the efficacy, it was a revolution because the PANSS score improved. Firstly, it improved very gradually, which could be sort of a disappointment as to why we didn't see an abrupt benefit. But then what we were really surprised by the fact was that it kept on improving. In schizophrenia, the usual teaching is the patients improve between 3 and 4 weeks of treatment. And after that, there's very little treatment. So if you're not a responder within 3 to 4 weeks, the likelihood of your improving from drug is very low. However, in this study, what we found is that even patients who had -- were not responders at 6 weeks, were responders at 6 months. And those who are not responders at 6 months, many of them converted to responder status at 1 year. This is a message of hope not just for this drug for the people resistant population, which is to say, don't give up hope stay with your medication. It may come late, but you will see the benefit. And we saw the same thing they were rating for the clinical global impression of change, which was done by psychiatrist. Patients were, in the end, consider a large proportion were considered much improved or very much improved. These are clinically meaningful impression improvements on these patients. And lastly, we saw a scale, which is known as the level of functioning scale. That also showed functioning was improving continuously till the end of the year till the last assessment the patients were improving. So really, overall, a very positive message from this trial, which puts us in very good shape for being able to initiate the next study. Next slide, please. In our regulatory program, you're going to have 2 studies. As I mentioned, 1 will be the non-TRS inadequate responder study. This is a placebo-controlled 4-week study because these are patients who are not treated with responders, they respond pretty quickly. This is a study looking at the effect of 30-milligram BID on top of a second-generation antipsychotic compared to placebo. The 260 patients that are to be enrolled in this study, which is being done almost in 6, 7 countries in Europe, Asia and then in Latin America. We expect the results by the end of this year. The second study, which is a very interesting landmark study in the making is a study in TRS patients, which we expect to start by the end of this year. This will be a study in which the primary endpoint now we think would be the 10 weeks or 12 weeks. Initially, we had thought 6 weeks after discussion with the FDA, FDA asked us to make it 8 weeks after looking at the results which I just shared with you, we think probably 10 to 12 weeks would be great. With this, we'll carry the study out for 1 full year placebo-controlled, but the primary analysis would be done after 10 weeks or so. Why 1 year placebo control? Because we want to be able to demonstrate that not only do we have a response for 10 weeks, but this response is maintained long term for efficacy. And this is a study which we are really anxious to start. This will be at least 450 patients will be randomized equally to 15-, 30-milligram BID or placebo. The study will probably take about 18 months to complete from the time we start. Next slide, please. XADAGO, our first compound, sodium channel blocker, also having the propensity to inhibit excessive release of glutamate, and shown efficacy in patients with dyskinesia, but approved currently for treatment of motor fluctuations in patients on L-Dopa. This drug was almost completely developed by neuron. It was the first drug to be approved in 10 years. The new chemical entity in Europe and the U.S. when we got this approved in '19 -- in 2015, is globally licensed, royalties are coming in, is growing but at a slow rate, but we expect that this drug will continue to be a source of income for the next few years. Next slide. As I mentioned before, XADAGO or safinamide is marketed worldwide. You can see that in different regions of the brain, of the world. Basically, we have different partners to whom the drug has been licensed. Parkinson's disease, as you all know, is a massive disease. Again, it's about 7 million to 10 million people worldwide, and patients will take medication for about good 20 to 30 years. We have -- in Europe, the drug is marketed by Zambon our partner, as also in parts of Latin America and Israel, we have medicine in Japan. We have Eisai and Meiji. And Australia and New Zealand, with Seqirus is our partner. So again, the following this model, we expect that we might be having different partners as we go along for evenamide. Next slide, please. I think I'm going to at this stage, turn over to Roberto Galli, the Chief Financial Officer for Newron to walk us through the financial situation. Roberto?

Yes. Thank you, Ravi. So Newron number of shares of listed shares at the end of the year were 17.8 million. They are ordinary shares, and they are listed at SIX and separated, as Stefan was saying before, on the electronic platform, et cetera. Out of those 17 million shares, the senior managers and directors, hold about 0.6%. Newron during its life has issued also several options or very lately also warrants, we have about 2.5 million of those collections outside of which is 4.7% is held by managers and directors while EIB holds all the warrants, so 4% fully diluted. No need to say that if you want additional information, you can double check on the Corporate Governance section of our annual report. As usual, I want also to say thank you to all our analysts so let's start from Samir and Bob that are joining us that are on the call as well, plus Leonildo from Baader Helvea and Soo Romanoff from Edison. We have a Zambon that is the only material shareholders, at least at the best of our knowledge that has about 4% of the company. Moving on the next slide. As Ravi was saying, royalties are increasing 4% if compared to the 10% of last year, and we might expect additional increase in sales in '20 this year and the year to come because we know that some money is very active in finding partners, for example, right now in Eastern Europe. R&D expenses grew slightly as compared to 2021, mainly because of the start of the pivotal study, the 008A study that Ravi was mentioning to you during his presentation. And the delta between operating loss and bank loss is mainly financial losses that increased up to EUR 4.2 million, mainly because of the EIB loan. So last year, at the end of 2021, we called the full EUR 40 million. So the impact now is the interest that we pay on those EUR 40 million. The balance sheet, noncurrent assets decreased mainly because the use of the R&D tax credit, you know that we have this benefit in Italy through which companies investing in R&D doesn't pay a certain amount of taxes. It's better to say we pay them, but we can use this receivable. And in the 2022, it decreased by EUR 2.3 million. That is the quote that we have used. And more or less, this is also what we expect to use in 2023. Noncurrent liabilities increased mainly because I said before, we called the last tranche of the EIB loan. The -- if you look at the right, on the right box, so the cash flow, please note that the blue bar shows not only the cash, but cash and other financial assets. The working capital movement are as usual adjustment for nonmonetary items, and then the movement -- and the standard movement in payable and receivable. Given that we are talking about cash, please note that recently, we following what happened to the Silicon Valley Bank, we checked our investment in the financial assets. And we realize that we are not directly -- they are not directly or even indirectly invested in Silicon Valley Bank or the other banks that are currently facing trouble in U.S. Our funds are also well spread among different assets and assets are only in Europe. So next slide is the one that refers to the shareholders' meeting that will happen on April 18 at 10 a.m. here in Newron. As usual, we will ask shareholders to approve the 2022 financials. And in this year, we have to reappoint the full Board of Directors. We are going to ask shareholders to approve as last year as in those years, Ulrich Köstlin as Chairman, Stefan Weber as CEO; Patrick Langlois and Luca Benatti. And then we are adding Gillian Dines, a new member. If you want to have a look to her bio, you can go to the Board report on the 2023 shareholders' meeting that is on our website. But just to give you an idea, Gillian is the Senior Vice President of Jazz Pharmaceutical. She has more than 20 years of experience in R&D, starting from research and development, approval and commercialization. She has experienced -- a lot of experience both in big pharma like GW Pharma, UCB and GSK, but she has also experienced in the biotech environment. She is English and she has a Master of in Technology -- in Toxicology, sorry. So having said that, I have finished, and I will leave the word to Andre.

[Operator Instructions] The first question comes from the line of Bob Pooler from ValuationLAB.

Again, congratulations on a solid 2022 and the progress you made with evenamide. A few questions first on the guidance of cash well into 2024. Firstly, does that include the Zambon fee for the PD-LID trial that has been discontinued?

Yes, absolutely, yes.

Okay. And does it include any revenues from partnering of evenamide this year?

No, no, no. Absolutely not. I mean, as usual, what we are taking into consideration are real stuff. So what I can add on top is that we have considered, of course, royalties coming in and the use of the R&D tax credit. So this is what it is in our cash balance. I mean nothing fancy.

Okay. So they could add on top of it. And then just finally on the guidance there, do you expect to have similar costs in 2023 as seen in 2022, roughly?

Sorry, I didn't get.

Do you expect similar -- the cost that you're going to spend this year, operating expenses this year, will they be roughly similar to last year's?

Well, I think, yes, because -- yes, I think, yes, until the 003 study won't start. But in that very case, most likely, it will be financed by a partner.

Okay. Then going to XADAGO. What is the reason to discontinue the label extension in PD-LID?

Thank you for the question, Bob. Stefan here. I think it was us looking into the mirror and accepting as a fact that our partners who, in that case, our clients were not interested to perform that study. XADAGO has acquired, as you know, Adamas competing compound. Now we can dispute if they did well. I am convinced that XADAGO would have been a better compound. But no need and Zambon confirms that they would not wish to perform the study, and then we have to face the reality and we have to talk to someone and say, okay, how do we settle and they gave us a settle payment and that's it. And we take the money and we start something which builds more value for our shareholders.

Okay. Okay. Then just on Study 14. That is the final safety trial that's required with the FDA before we Study 003. When do you expect to have discussions with the FDA on the trial results, which are imminent probably next week or over 2 weeks?

Yes. I think Bobby will be submitting the package with the new protocol. As you know, you have new protocol also for discussion. So we expect to do that end of March or beginning of April. So that is usually about 45 days.

Okay. So around that time after that time, we could expect then maybe some news flow on the Study 003 on the trial design and when to use that.

Will probably announce that at some time with the final trial define.

Okay. And then just one final one. How are the partnering discussions ongoing, especially on the exciting news evenamide? And do you expect anything starting maybe even before Study 003?

Yes, Bob, I think we saw a lot of dynamics, thanks to the results in treatment-resistant schizophrenia. Our business development is very busy these days. And we are looking forward to getting some promising partners on board. And yes, we would expect that a partner would join Newron before Study 003 effectively start to this year.

[Operator Instructions] The next question comes from the line of Samir Devani from Rx Securities.

Maybe I'll just pick up from where Bob left off perhaps just on the PD-LID study and the settlement payment. Was that booked in the '22 accounts? Or has the cash been received, I guess, is the question?

No, it will be booked in 2023 accounts because the deal was closed yesterday night.

Yes, I know. And can you maybe comment on how meaningful that settlement payment is? Is it over EUR 1 million?

It is 7-digit and it is low 7 digits. I mean, I think that is as far as we can go. So it makes a difference, but it doesn't change the world.

Okay. Perfect. And then I guess the remaining question is really on XADAGO. We're obviously going to be talking about evenamide in a couple of weeks. Can you just help us understand maybe a little bit more of the sort of geographic split on the royalty line? I mean, approximately how much is U.S. ex-U.S. in terms of the royalties currently?

The only thing what we can, that we can say, Samir, given that we don't have access to the sources, but we are just getting reports. It is one of the rare drugs where the vast, the very vast majority of revenues comes from Europe that you might say that is more than 75% coming from Europe and a very small share is coming from the United States. That's as far as we can give.

Yes. That's perfectly helpful. And then I guess, just thinking about the sort of litigation case that's ongoing. Can you just -- can you comment at all as to -- is that focusing on one of the patents being infringed? Or could you make any comment in terms of the details on that at all?

No, we cannot. Samir. I ask for your understanding. This is a business between us, Zambon and Supernus. We can't tell you that we are at core, it takes up to 2 years to defend the patent. Our understanding from our discussions with our partners is that we have all good reasons to be very confident that we will prevail over those generic suppliers, but more, I can't tell you.

Okay. I guess the reason for the question is, as you highlighted, there's more revenue coming from Europe, we don't get a huge amount of visibility on generics in Europe. So when you talk about having -- are these the same 3 -- the Orange Book patents, are they the same patents that would defend your position in Europe? Or is there any distinction between the IP positions in the 2 territories?

No, basically the same patents.

There are no more questions from the phone.

Thank you, Andre. So we check for the questions from the webcast. We have a question from Carlos Borges from TPL company. And the question is, how large is the present world market for schizophrenia medication? I think what we can say is we found late alias market research information, which says that the market right now is at $7.2 billion. That's 2021, so that's 2 years ago. And the market is expected to grow to $12.5 billion in 2031. That's an average growth of 5.8%. I think it is very important, Carlos, to mention that the vast majority of prescriptions will be for generic drugs. That means the large chunk of the market is for generic drugs and that any innovation will obviously drive the sales substantially up, and we know that any new drug that is approved and is coming with patent protection, will do more than $1 billion of sales easily. Anything that Ravi or Dennis would want to add to those?

Yes. I think you just have to keep in mind that the current sales have been really not reflective in number of prescriptions because almost all the drugs are generic. But starting from last year and continuing in the next 2, 3 years, there are expected to be about 4 to 5 new product launches they definitely will increase the size of the market because they'll be much more expensive than the generic mark.

Thank you. We don't see any other questions right now in the webcast. Let me ask a last time for an update. That is not the case. Then I would like to thank you all for attending this call and for asking the questions. Thank you for staying tuned on Newron. Please remember that it is less than 2 weeks' time that you will hear from us from evenamide. More fascinating news as we hope and expect. It will be a good year for Newron and our shareholders and for the patients soon, hopefully. Thank you. Stay tuned. Have a good day.

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