Neuren Pharmaceuticals Limited (NEU) Earnings Call Transcript & Summary

Good morning, and welcome to today's investor webinar to discuss Neuren's First Half 2026 Financial Results and the company's first ever dividend program. My name is Gerry Zhao, Chief Business Officer at Neuren. Joining me today are our Chairman, Patrick Davies; and Chief Executive Officer, Jon Pilcher. Jon will make the presentation followed by a Q&A session. A copy of today's presentation has been released to the ASX and is also available on our website. [Operator Instructions] Before proceeding, please note that today's webinar will include forward-looking statements, which are subject to risks and uncertainties that may lead to different outcomes. I'll now hand over to Jon to commence the presentation.

Thanks very much, Gerry. Good morning, everyone. Thank you for sparing your time to listen to us this morning. We are going to try and keep this to 40 minutes, if we can. We've had some pre-submitted questions, many of which I'll address during the slides that I go through, and then we'll come to the other questions. But apologies in advance if we don't get to your questions as we are going to stop after 40 minutes. So, I want to start with this slide, which we've used for a while. And this is my mantra to investors that I strongly believe you can get the best of both worlds with Neuren. So, you have $287 million of cash -- the cash generation, strong generation from DAYBUE. And that picture has just got stronger again with the approval yesterday in Europe, which I'll come to in a minute. So, you have all of that. But then you also get to participate in the potentially big value capital upside of NNZ-2591, being developed in multiple indications, but with Phelan-McDermid syndrome strongly leading the way and the Phase III results in that being the big catalyst from a value point of view. And very rare to be able to participate in that, but have your downside protected by the value of DAYBUE and you're not facing dilution from capital raises or any pressure on the share price from capital raises. So, I really think it is a unique position that we're in and a unique proposition for investors. And I guess we've recognized that to a little bit more of an extent today and recognize the great success of DAYBUE by announcing our first ever dividend program linked to DAYBUE. So, let me go into the details of that. So, this is an ongoing program. We anticipate it will be semi-annual payments, so an interim and final. And we've identified what we're calling an available pool, which is the royalty income from DAYBUE, less our corporate and admin costs, less tax that becomes our available pool. And then we've set a 70% to 100% range of payout of that pool. And today, we started at the 90% level. So, we're paying out 90% of that pool in that $0.15 per share interim dividend and it's fully franked. As most of you will be well aware, we have a large pool of franking credits. It's about $76 million, I believe. So, this dividend is fully franked, and we intend to frank future dividends to the maximum extent that we can. That dividend is going to be paid on the 7th of October, and there will be some extra communication coming from our share registry to shareholders in coming days. But I wanted to tell you today, those of you on the call who are shareholders, very important that you have your account details of where you want that dividend paid to registered with the share registry, very important that you get on and do that. There will be, as I said, more correspondence coming out around that in coming days. Just let me touch on the full year. So in this table here and in the announcement this morning, we set out both the calculation of this interim dividend, but also what the full year may look like. Of course, we have guidance from Acadia for sales, which allows us to have our guidance for royalty income. And therefore, it gives you a range of what the available pool might look like, and it's $48 million to $51.6 million for the full year. So, that gives you some indication of what the available pool might be in the second half for the final dividend. So, I think a big moment for us, and I see this as an ongoing incentive -- added incentive to hold the share. Now, what I want to say is it doesn't mean that capital growth is not important, and it's still the most important thing for me personally as a shareholder, it's absolutely the most important thing. And the progression of 2591, obviously, is a critical part of that. But I think this is a very good addition that optimizes the return to all of us as shareholders. Let me just have a few words about the half 1 result beyond the dividend. So in U.S. dollar terms, just over USD 23 million of royalty income earned in the first half and USD 53 million to USD 56 million being the expected outcome based on Acadia's guidance. As you know, historically, very modest corporate and admin costs that continues $3 million for the half year, more than offset by our interest income of $5.6 million. So, that obviously remains a very strong position. A feature of this half was quite a big step-up in R&D investment. So, that grew to $27.4 million, which was completely expected given the progression of the Koala Phase III study. The overall cost of the PMS program to get to new drug application remains within the range that we've set from the start, USD 80 million to USD 90 million. And that step-up in R&D will obviously will continue as we go through the remainder of the trial. So at 30th of June, really strong cash position, still $287 million, and that means all of our 2591 programs are fully funded. So again, if you think about the dividend pool versus the rest of the business, the R&D really then gets funded by the cash and the future milestone payments. And the extent of that funding is going to depend a little bit on how we progress with the programs, not PMS, which is sort of set in stone, but how we progress with Pitt Hopkins and HIE and our interactions with FDA, which I'll come on to later in the presentation. So, really strong financial half for us again, and we're in a great position. Moving on from the financials. If we think sort of qualitatively about what has happened since 1st of January, you get this incredibly busy crammed slide, which I think is a reflection of the huge amount that's happened in those 8 months. And I think -- so we've got DAYBUE at the top of the slide here and 2591 at the bottom. So, let me start with DAYBUE. I mean, an incredible period really, limited launch of 6 in the first quarter, then broadly the broader launch in the second quarter and the great outcome from that, which continues. Of course, we had the big disappointment in February of the CHMP giving a negative opinion on the European approval. But then we got the fantastic turnaround in June where that opinion was reversed. And then yesterday, we got the formal approval from the European Commission. So, what a fantastic outcome. I mean, for the Rett community, as I've said before, it's was a terrible outcome back in February and a fantastic outcome now. And I have to give huge credit to Acadia for the determination they showed to get that turned around and obviously, with the big support of the Rett community. So, fantastic outcome for us and I'll come back to that again in a minute. Another important thing that happened was the Delphi expert consensus report, which formally recommended DAYBUE as part of the standard of care for Rett in the U.S. That was an important step forward. So, I think the great performance of STIX then led to Acadia upgrading their guidance for the year, which was obviously fantastic to see. So, a really strong period for DAYBUE. And then if we switch to 2591, started with the publication of our Phase II study, which is important from a sort of scientific credibility in the scientific community. Then really importantly, we had the first patient dosed in the Koala study in the placebo-controlled part of the Koala study that was in February. And then a few months later, we have the first patients going into the open-label extension part of that study. We got our feedback on -- from the FDA on Hopkins and HIE, which I'll return to in a minute. And then importantly, the Priority Review Voucher program, which we tend to forget about, got reauthorized by the U.S. Congress and the latest sale of a voucher was USD 215 million. And remember, we own the right to this, ourselves, 100% this time. So, that was a very important thing that happened during the period. And then more recently, the study that was published showing that the prevalence of PMS is higher than previously thought of before. And then we had a big presence at the PMSF Family Conference, which I'll again come back to in a minute. So, an amazing 8 months really and has just left us in, I think, the strongest position we've ever been in. So, I'm going to spend a few minutes just talking more about DAYBUE and then a few more talking about 2591 before we conclude. So DAYBUE, which obviously, the strong momentum in sales and therefore, the royalty has obviously driven the dividend announcement today. So, Cathy's Q2 earnings call was fantastic, really strong growth in Q2 versus both Q2 in the previous year and Q1 this year and the upgraded guidance of both the lower and upper ends of that guidance were raised by USD 20 million, so USD 480 million to USD 510 million now, the guidance for the year and with the consequential increase in our royalty guidance. STIX, I think we had high hopes for it, but I think that's been exceeded really. And Cathy said that by 30th of June, 40% of DAYBUE patients were on STIX. So, that's an incredible outcome really when you think about how recently have been launched and a lot of new patients and returning patients. And that's the most important thing for us. I mean, the switch from the liquid to STIX doesn't really have any impact on us from a revenue point of view. I mean, it's good to see if families are doing better on STIX. But really, the impact on us from a revenue point of view is the new and returning patients and certainly very encouraging early signs on that. But I'm obviously more excited by the long-term story now. So remember in the U.S. that we've still got many, many patients who haven't tried treatment yet. I mean, Acadia didn't provide updated numbers in this quarter, but in the previous quarter, the penetration into the centers of excellence was 60% and only 28% in outside that setting, and that's 2/3 of the patients. So there's still -- the scope for growth in the U.S. alone is still very significant. But now we have the intact story that was always there. You've got that growth in the U.S., but then you've got following behind it, Europe, and then you've got following behind that Japan. So, a really strong long-term growth story, which financially for us, both in terms of milestone payments and royalties is just really strong. Let me just talk about a couple of milestone payments here. So on the left-hand side there for the U.S., and it's actually North America. So technically, it's U.S., Canada, Mexico. So the next milestone payment we could earn is when sales in a calendar year exceed USD 500 million. We get a USD 50 million one-off milestone payment. Now, I just want to make sure people understand the guidance that Acadia has given for this year, which I guess the brackets, $500 million is for global sales. It's not the North American sales. And so the top end of the guidance is $510 million, and I would expect there to be more than $10 million in ex-North America sales this year. So, I don't want you thinking that, that guidance range means that, that milestone payment necessarily will come this year. Of course, it could if they significantly exceed that guidance. But we're certainly very optimistic about that for the following year. Acadia has reiterated a forecast of $700 million of global sales in 2028. So, that just shows the continuing growth that's expected. Then the other milestone payment I want to highlight is that the first commercial sale in Europe triggers a USD 35 million milestone payment. Acadia said that they intend to launch early in Q4 in Germany. And so we would expect that to trigger that milestone payment. And then also, it obviously unlocks a series of potentially -- a series of sales milestone payments and also royalties that, as you know, are higher than the U.S. royalties. And while I'm on this slide, I just want to mention one more thing I forgot to mention with the dividend. One nice thing about linking it to the royalties that there is a pattern of second half being bigger than the first half. And it's for 2 reasons. One is that there's that pattern of sales from DAYBUE anyway. But then if you think about our royalty structure in the first half, the first $250 million is at 10%, and then it jumps to 12% after that. So, there's a sort of natural growth of half 2 versus half 1, which I think is good from that dividend pool point of view. The last thing I'll mention on this slide is Japan, which is an exciting follow-on as well. So, Acadia is running a Phase III trial at the moment, which is due to read out September to November time frame. And hopefully, you know this, but I just want to reiterate, this is not a big Phase III trial where you're looking for statistical significance. It's a small trial. I think it's 24 patients. It is placebo-controlled, but all they're looking for is trends, not statistical significance. The application, the regulatory application in Japan is mainly based on LAVENDER and all the U.S. application, but this is a supplement to that that's required by the Japanese authority. So, very excited about that. We expect a regulatory submission in 2027 following the result of that trial. And there's a $15 million milestone payment coming to us on the first commercial sale and again, with the higher royalty rates. So, I think, as I said, really, the DAYBUE position couldn't be any better and strengthened very significantly during this period, which is fantastic to see. Okay. Let me move to 2591. And obviously, I'm going to spend most of the time here talking about PMS, but I will come on to the others at the end. So just a reminder, this is a big deal. This is the first ever Phase III trial for Phelan-McDermid syndrome. We're trying to be the first ever treatment approved as we were in Rett. We've got all the designations you would expect, Orphan Drug, Rare Pediatric Disease, which gives you that -- the ability to get that Priority Review Voucher. We were highly encouraged by our results in our Phase II trial. We went through a painstaking process with the FDA to agree the design of the Phase III and agree that if we get a positive result, we can file a new drug application. And the Phase III trial, the Koala trial is up and running and enrolling in both the U.S. and Canada now. So, let me just very quickly recap on what the trial looks like. So, a single Phase III trial. We're looking for 160 kids. They'll be randomized half and half to drug and placebo. They get treated for 13 weeks. And the result drug versus placebo at the end of 13 weeks is the primary outcome of the study. But they can then continue treatment for another 12 months, with everyone getting drug under the open-label extension. We've kept this as similar as we could to the Phase II. So it's the same age range, the same length of treatment, both is the same. We've kept the study mainly in the U.S. We've got one site so far in Canada, but mainly it's the U.S., which reduces the heterogeneity. So, we think this has got the best chance we can possibly have the success. As you know, 2591 closely related to DAYBUE from a biological point of view. So, we've always felt very good about the prospects here. And the other nice thing about it is that, of course, it was fully funded from our existing cash, as I said earlier. So, great position to be in. So how are we going? So, I'm going to talk about 3 different things on this slide, but we'll start with the right-hand side. So, we're gaining some great momentum here. So at the start of the year, we had only 2 sites activated and enrolling, but we've now got 15 sites in the U.S. and Canada activated. We're still expecting that to end up at somewhere between 20 to 24. So, there are still more sites coming, but we've now got 15 sites, which is a real good critical mass of sites all enrolling. We said this before, we've got more than 100 patients whose families have approached us, and we've referred them to sites who are either open or still awaiting activation. Of the 15 sites, 8 of them have now been activated for the open-label extension as well, which means that people completing the 13-week study can roll seamlessly into the open-label extension. And again, as the sites start the main trial, they'll get activated for the open-label extension too. Also had one nice thing that the first patient from our Phase II study has enrolled in the open-label extension. So, we've offered that to those Phase II patients. We couldn't do that, unfortunately, when we ran the Phase II trial. So, we're pleased to be able to offer that. Whether they all enroll is going to completely depend on their family circumstances and whether they meet the enrollment criteria for this trial, but we certainly hope that they will and the first patient is up and running. So, lots of pre-submitted questions about how long is this going to take? When are we going to get results? So, let me deal with that. And I'll say that at some point, we will give out formal guidance of when to expect top line results. We're not there yet. We're not far enough through our enrollment to do that yet. which means I will use the sort of the informal benchmark that I've used from the start, and many of you will have heard before. And that's the LAVENDER trial in Rett syndrome that Acadia ran. And it's a good benchmark because the number of patients is similar. The trial design is very similar. Some of the sites are the same. So, there's a lot of similarities. So, Acadia took 2 years from start to top line results for that trial. And before I talk about how we are going against that, I just want to make sure everyone knows this and apologies to many of you, I'm probably teaching you to suck eggs. But just in case anyone is not familiar with this, you might say, well, hold on, you've got 100 patients referred to sites. How can it take 2 years to get to the end of the study? These studies are very onerous, not just for the patients and their families, but for the sites as well. And so they can't have loads of patients all turning up at the same time on day 1. It doesn't work like that. They have to take them stepwise, patient by patient. And of course, you start with not many sites and then gradually build out the number of sites as we have. So therefore, it takes quite a long time to enroll all the patients. And the results of the study all depend on when you enroll your last patient who then goes through the 3 months of treatment. So for Acadia, it actually took -- it was more than 18 months to enroll the patients. It took about 20 months to enroll the patients in order to get that 2-year results time line. So, how are we going compared with that sort of informal benchmark, I guess, our aspirational benchmark? So, I think with 15 sites all enrolling now, we're in a great position. And I'll give you an important statistic is that right now, there are 15 patients in screening. And so I just want you to think about the math here. There's a 4- to 6-week screening period in this trial. So if those 15 patients don't screen fail, then they all become enrolled patients a month later. So if we keep that trajectory, you're talking about sort of a 1 patient per site per month sort of trajectory. And it doesn't mean it will be that for every site. Some sites might have more, some sites might have less, but that's the sort of average. If we can continue that trajectory, then we're in very good shape for that sort of informal aspirational benchmark. So, that's as much as I'm going to tell you today. I think as I said, at some point, we will turn that into a formal guidance on results. And we'll also -- when we reach something like a 50% enrollment milestone, we'll certainly tell you that as well. But overall, feeling really good. I think momentum is building now. As I said, we started in a very small way with 2 sites. Now we've got 15 sites, which is -- the power of that is infinitely bigger. So, we're in a good position. Two more things to mention on this slide. So, I referred to it earlier. So, this new study suggesting the prevalence of PMS 1 in 7,300 people or could be 39,000 in North America. Again, just emphasizes the huge need here and the need, not just for treatment, but for better diagnosis because it's just so heavily underdiagnosed, but that's really -- that's a fantastic target to have to try and raise the diagnosis towards that sort of number. Then the last thing I want to talk about in this slide is the Phelan-McDermid Syndrome Foundation Family Conference. So, we put out an update last month from the conference, we were the presenting sponsor. We were there en masse 12. 12 of us attended that conference. I was there for the whole time in Colorado, in the U.S. And I have to say for the whole Neuren team, it was incredibly inspiring and energizing. There were more than 800 people involved in the conference, which was incredible and shows the huge progression the Phelan-McDermid syndrome community has made in recent years. You wouldn't have had anything like that a few years ago. And the energy in the conference was amazing. But the most amazing thing was spending time talking to both parents and siblings of PMS kids and hearing their stories, not just about the kids and what's important and what they're looking for in a treatment, but diagnosis stories from diagnosis at 6 months old, which is great, to diagnosis at 42 years old, which is terrible. So it was just incredible for me to have all of those conversations and hear all of that and incredibly valuable. And I have to say that personally, it's made me doubly determined that we make a success of this because we can have a huge impact here if we're successful here and get the first treatment approved. And I think that's going to be incredibly rewarding for all of us and also for all of you as shareholders. So, really doubly determined, and it was a very important few days that we spent there. So, let me just move on and bring in the other indications. So this, I guess, is the mirror image of what I showed at the start, which was what had happened in the last 8 months. This is what's coming up. Again, a lot of milestones, important catalysts coming up. This time, I'll start at the bottom of the slide with 2591 and then move to DAYBUE. So, let me now talk about the 2 other indications. And I'll start with Hopkins syndrome. So, I'm really, really pleased to have announced this morning within our update that we have now got a scheduled date in October for a Type B End of Phase II face-to-face meeting with FDA, and I deliberately go through each of those things because they're important. You remember, I complained that we just got written responses in that previous meeting, which was really unhelpful. This time, we have been granted a face-to-face meeting, and that is good. It's actually not common these days to get that. So, I'm really pleased to have got that. And also its designation as an End of Phase II meeting, again, acknowledges that what we're talking about here is the Phase III study. So, you'll remember that FDA said that we did the same thing as we're doing with PMS from an endpoint and design point of view that will be acceptable and our position was, well, it's just not executable. And it's not -- you shouldn't have to do that for a condition this rare and this severe. So, we spent a lot of time looking at alternative designs and alternative ways of analyzing the endpoints. And we're now really looking forward to getting to Washington in October and discussing that with FDA. So, very pleased about that. And then another interesting thing, I think, with Pitt Hopkins, which just shows again that, that community is on the move and things are moving. And that's the externally led patient-focused drug development meeting, which is going to be held in November and that's where FDA and the community come together to talk about it. There was one for PMS and there was also one for Rett syndrome, and both of those were very useful. Really does give the community the opportunity to educate everyone about what Pitt Hopkins is, what they're dealing with, what's important, what's important to do something about from a treatment point of view and a diagnosis point of view and really get FDA's head around all of that. So, that's going to be an important meeting that we'll support as much as we can. Then let me move to HIE. So if you remember that what happened in February was we proposed a study to be able to file an IND and FDA was broadly okay with that, but said we want you to do an additional juvenile animal tox study before you do that, which was frustrating, but we were okay to do that. We actually submitted the protocol to them for review in mid-May, and we still haven't received feedback. We are expecting to receive feedback very soon, and we've been ready to start for a long time. We're ready to start as soon as we get that feedback, and we expect it to be imminent. It's a 3-month study. So, what it does mean is it pushes our ability to file an IND from Q4 this year into the first half of next year. But that's all it is. It's a delay. I mean -- and I think one thing to just point out to the different divisions of FDA to the one we're dealing with all the other programs, just importantly, understand that. So, obviously, I would like to have got some feedback much sooner. We expected it much sooner, but we still anticipate we're going to get it. So, then the last thing I'll say on the 2591, on the forward-looking road map, of course, the most important thing here is Koala progress. So, we'll be giving updates on that. As I said, at some point, we'll give you guidance on the top line results, timing and also some milestones along the way. Then if we shift to the top of the slide. So again, a great cascade of stuff coming with DAYBUE. So the results from that Japan trial between September and November. Acadia will give their Q3 results. So, we'll get more insight into how STIX is going. They've said commercial launch in Germany early Q4. There will be our milestone payment that gets triggered by first commercial sale. Then, obviously, be their Q4 results and then a Japan NDA submission. So again, a real rich series of stuff coming on DAYBUE. So, I think that's a great period coming up for us, which if all of this again goes our way, then we'll be in an even stronger position when we next look back on this progress. So, I think I will stop there. All I'll just say in conclusion is, as you know -- as you all know, I have been at Neuren for 13 years. It's been a hell of a long journey with ups and downs, but I really think we've never been in a better position than the one we're in today. And I think the dividend program is a reflection of that, but only part of it. We really are in a great position and determined to make the absolute most of it for all of us. So, thank you very much. We'll now turn to Q&A.

So, first question was a little bit of a follow-on about Koala. So, assuming that the Phase III trial is successful, what is your strategy for the company from there on? And then there's actually another question, which is probably I'll bracket with this. Has Neuren's stronger balance sheet made self-commercialization in the U.S. a realistic alternative? So, I think the position remains as it has been in the past that there are multiple options, I think, open to us post-Phase III. And I think they fall broadly into 3 camps; M&A of some sort, a licensing deal or deals, or could we commercialize it ourselves in the U.S.? And I still think those 3 remain live options. So, I think the commercialization one, I think, is less likely than the others as we stand today, but it's still a possible option if shareholders wanted it at that point in time. But I've said before, that would require a very big change to the company, probably a move to the U.S., different people, a big change. Now, one thing we do have to do. We do have to do some groundwork in that regard in advance of the -- certainly of the new drug application because if we're going to partner with someone or have an M&A, you don't want them starting from scratch and being held back from a time line point of view. So, we are already in the background, doing some groundwork in that regard, but it's not a big cost or big change. But I think it's important to have all those options as live options. If we're going to do any negotiating at the end, we want all of those things to be live options. Next question. Of the 2 co-primary endpoints agreed with FDA, this is for the Phase III trial, which do you consider the greater execution risk? And what gives you confidence that the Phase II treatment effect will translate into a placebo-controlled study? So, I didn't talk about this in the slides, but yes, there is 2 co-primary endpoints that we have to hit from an efficacy point of view. One is a physician measure. One is a caregiver measure. So, we have very conservatively powered this trial. So the more people you have in the trial, the greater your statistical significance of your result. And we have powered it based on the weaker endpoint. And that of the 2 is the Vineland, the caregiver 1 of the 2 endpoints. So it's 90% powered to get a result on that, which means the power is much higher on the other one. So, I think the straight answer to the question is that that's theoretically the riskier, but we think we've powered it to such an extent that we think the probability of success is high. And then if I think about Phase II to Phase III, as I mentioned, we've kept everything that we could the same. So the only difference is we're bringing in a placebo group, which is not a trivial difference, but we've done a lot of analysis on how placebo group performed in a Phase II trial that was run by one of our investigators in using IGF-1, and we've been able to make, again, some very conservative assumptions from that to give us a number of patients in the trial. So, there's no slam dunk ever in the clinical trial, but we feel as good as we can do about this one. Okay. This is switching to HIE. When are the results of the HIE Juvenile animal study expected? And will the results only be safety related? Or will there be any behavior change or brain scan data as well? So look, this is purely a safety study, and it's a standard safety study that you have to do in normal animals before you can get into humans. So if we're able to start imminently, as I said, then we would get our results December and then early next year. But you are right, I don't expect them to be announced. You don't announce the results of these sort of studies. All they are is data that you need to put into the IND. There's no efficacy involved here. Assuming the Koala study is successful and 2591 is approved, can you envisage clinicians might try to use it off-label for Pitt Hopkins and HIE before those trials are completed? So look, formally, companies, they certainly kind of encourage off-label use. In fact, they should discourage it. So, we're certainly not going to be trying to make that happen. And I think I always feel in all these indications, it's unlikely because the cost is high and it's generally funded by insurers or by governments, and they will typically require evidence of a diagnosis. And in our syndrome cases, it's a genetic test in order to agree to fund it. So, I do think it's very unlikely that you get cross-use for that reason. Next question. Could you please give specific details on European sales milestones and royalties? When can we see the breakdown of the USD 170 million sales milestone payments? Thank you. In case, you remember my slide I showed with the sales milestones and then royalties, but not the same detail as the U.S. So, look, Acadia hasn't disclosed any of that yet. So, we can't. I think we will at some point, we will need to discuss that with them. That happened with the U.S. We didn't disclose that until the drug was launched and being sold. The pattern is similar to the U.S. as you saw on that slide. But yes, we can't tell you that at this time. Next question. Does the success of DAYBUE surprise you? Do you have the same positivity within NNZ-2591 as you did with DAYBUE? So, success of DAYBUE doesn't surprise me. I mean, I think the unmet need is enormous in these conditions. Obviously, I've been here 13 years. I was always a believer in DAYBUE and the results we got. So no, it doesn't surprise me. I do think Acadia has done a great job, continues to do a great job with that community, but certainly doesn't surprise me. And then the second part of the question, well, any of you who've been following me for a number of years will know that I have more positivity with 2591 than DAYBUE. I've always been a big believer in 2591 and was a big component for us propelling it forward from the start. So yes -- and I still have that same positivity. We're excited about the prospects for 2591 and what we might be able to do with it. Okay. Right. I think I've sort of answered this, but let's reiterate it. So, Koala trial progress, 15 sites, open 8, managing open-label extension patients. Any color on the number of completed patients thus far? And will you provide the market recruitment milestone updates like 25% or 50% or enrollment complete? So yes, I think I already said we will provide those sort of milestone updates. I'm not going to talk about specific patient numbers other than you're right, we've got multiple sites with open-label extension patients in them. Okay. Next question. Any particular reason the meeting with FDA for Pitt Hopkins is before the caregiver meeting with FDA in November? Would it be more logical to do it after? That's easier to get alignment on the trial design. Yes, it's a fair question and we've considered that. The trouble is we've already waited so long for that meeting. And really to get a face-to-face meeting, there were limited options. And so if we said no to that date to get a face-to-face meeting, we may well have been not 2 weeks later, but a very significant amount of time later. So, we don't think that's the right thing to do. We need to get going. And we don't think that, that meeting is not going to change our approach and what we think is the best thing to do. I think it's just going to increase the knowledge of all the components, which will be very useful, but I don't think it wouldn't make any difference to our approach to the meeting. Okay. A question, obviously, I think from a New Zealand holder. Will the dividend have any NZ imputation credits? So, look, we've paid a huge amount of Australian tax. We haven't paid any New Zealand tax, and that's partly because we had a very large amount of New Zealand tax losses from the early days of Neuren before my time. So no, we don't have any imputation credits for New Zealand, I'm afraid. But one thing also because it's fully franked, there'll be no withholding tax for overseas holders. All right. Another question about Koala. How is R&D expense tracking versus expectations for Koala and other pipeline investments? How lumpy is half year R&D expense, and then looking for some guidance on that. So, I think I said during the presentation, our USD 80 million to USD 90 million guidance for the total cost still intact. So, that hasn't changed. The other pipeline investment, to be honest, it's uncertain because until we have that agreement with the FDA on Hopkins and on HIE, we won't know the total quantum of that. I mean, I think, obviously, we're expecting and trying to have a smaller trial of Pitt Hopkins than the PMS trial, and we won't need to do some of the ancillary stuff. So, I would expect the overall cost of Pitt Hopkins to be less than PMS. But that's probably about as much as I can tell you other than, obviously, the step-up in this half. You'd expect that to continue through this year and next year given the PMS program progression. Okay. A question about the dividend. Okay. So, why doesn't the full-year dividend earnings -- so we're now talking about, I think, the available pool that I talked about that calculation. Why doesn't include the potential of USD 35 million milestone payment for the first sale in Europe? And if the first sale is made, will the dividend be increased to reflect the same? So, we've deliberately set the policy is linked to the royalty and the growth path that gives you, so the growing pool available for dividends. I think as I mentioned in the presentation, on the face of it, our R&D has now got to be funded by the cash and the milestone payments. And whether all the milestone payments are needed for that or not will be a judgment that we'll make as we go along. So, we don't have -- we haven't got that milestone payment yet. Obviously, we expect to get it. And there's a lag between earning it and receiving it. So, we wouldn't receive it anyway until first quarter next year. But with all those milestone payments, we'll just -- we'll make a judgment as our certainty around the R&D, obviously, crystallizes a little bit over the coming months. Okay. The Acadia guidance was given pre-EU approval. I found their commentary a little unclear as to whether Q4 EU launch or the Germany launch was included in their guidance. So, look, I think, obviously, it was given pre-approval, but it was given post the decision, the positive recommendation, which I think everyone felt was 95% likely to result in approval. So, I think they will have factored that in. Now whether how conservative they've been or not, it's up to them. But it was given post the change in recommendation. Okay. Question on -- sorry, I'm just conscious of time. I said I'd stop after 40 minutes. We've gone past that, so we'll try and wrap it up very soon. Any progress on Canada insurance coverage for Rett? So, I did see a report that On Fund had said they were going to fund it. I don't have any update beyond that. So yes, nothing to add on that, I'm afraid. Right. Let's take this as the last question. So, I noted there's a Type B meeting for Pitt Hopkins in late October. What do you anticipate the outcomes of this meeting are, i.e., will you come away with the ability to start a Phase II/III trial or anticipate further FDA meetings before any trial start? So, we're going to that meeting proposing what a Phase III trial should be. And so the best outcome is going to be, yes, we can go on and do that. I mean, that's certainly what we're hoping for. I guess the fallback from that is there's some aspect of it that needs further refinement, but that's certainly not what we're hoping for. We're hoping to be able to proceed following the meeting. All right. Thank you so much all of you for sticking with us for 48 minutes. Eight minutes over my stated deadline and look forward to talking to you again next time. Thank you.