ACADIA Pharmaceuticals Inc. (ACAD) Earnings Call Transcript & Summary

Welcome to the Morgan Stanley Global Healthcare Conference. I'm Jeff Hung, one of the biotech analysts. For important disclosures, please see the Morgan Stanley research disclosures website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. For this session, we have ACADIA Pharmaceuticals with CEO, Steve Davis; CFO, Mark Schneyer; and Head of R&D, Elizabeth Thompson.

Thank you.

So for those who may not be as familiar with ACADIA Pharmaceuticals, can you provide a brief introduction?

Yes, sure. So at Acadia, we focus on areas of high unmet need where typically, there are no drugs approved. So we have two commercial products: NUPLAZID for Parkinson's disease psychosis, where we are in our eighth year since launch and DAYBUE for Rett syndrome, where we have we're in our first full calendar year of launch this year. Each of those franchises are cash flow positive. We're a very cash flow positive company as an entity and with a very strong balance sheet. And in addition to leveraging those 2 franchises, we have 2 late-stage programs, one in -- for Prader-Willi syndrome, another rare disease in addition to Rett syndrome. And then we have a Phase II, Phase III program in Alzheimer's disease psychosis with our next-generation 5HT2A blocker. So this is a molecule that's in the same general class and category as NUPLAZID, our drug for Parkinson's psychosis. And for this drug, again, we're pursuing it for Alzheimer's disease psychosis, which is about 7x the size as Parkinson's disease psychosis. We have a robust early-stage portfolio beyond that. A little over half of it is not disclosed and almost half is disclosed. And business development continues to be a very important pillar of our business DAYBUE, our Prader-Willi program are good examples of some of the success we've had in business development, and we continue to focus on both our neuropsychiatric franchise as well as our rare disease franchise. As I've said for a couple of years now, you'll see a firm footing in both of those franchises, but you'll see the mix shift more and more towards rare disease.

Great. Let's start with DAYBUE. Now that we're about 1.5 years into the launch, how should we be framing our expectations for the cadence or trends of new patient starts?

So there's a little bit to unpack there. Let me -- I'll start with just kind of a brief history. So when we launched DAYBUE, the first and only drug approved to treat Rett syndrome, we had a big surge of demand that came through. Now many times on rare disease launches -- actually, if you look at rare disease launches, you'll see that there -- those listening in, I know you can see a hand that there's a kind of a linear curve that they typically follow. What you don't see that's behind that is there usually is a lot of demand, in particular, this is the first drug approved for that indication for -- in rare disease. That demand, though, gets metered out over multiple quarters, primarily due to just the time it takes to establish access with payers. This also gets metered out a little bit due to just time it takes for patients to get in to see their physicians. And -- but in our case, we had done a lot of work with payers before we launched, and so we -- the access came really quickly. So what that meant is that what typically is kind of a bolus and a backlog of demand that bleeds out over 4, 5, 6 quarters came all in a couple of quarters. And so we gained -- obviously, a real benefit to the community being able to get them started much more quickly. And an advantage to us as the sponsor of the drug, is it put us in a position where we almost like leapfrogged a year forward in terms of the amount of data that we have in the commercial marketplace. So we're doing a real-world evidence study. We call it our LOTUS study to collect data about the real-world experience that patients have on therapy. And that's really important when you launch a drug, particularly in a rare disease case in particular, where there's never been a drug approved before to be able to gather that information, distill it and then feed it back to the medical community and in this case, also the caregiver community. So we're well ahead of plan in being able to do that today. Where we stand today is we have a more steady cadence of new patient starts, which is much more similar to what we projected before we started and before we saw this big bolus of activity coming through. We -- there are 3 different types of treating practices or physicians, those that practice at a center of excellence. There are 20 centers of excellence currently for Rett syndrome. That -- and they treat about 25% of the patient population. About 60% of patients are treated, what we refer to as high-volume institutions. So these are not COEs, but many times, they have the look and feel of a COE. Sometimes they have the infrastructure of a COE, sometimes they don't, but they typically tend to be academic centers or just very large medical practices that have a higher density of patients. And then the final 15% come from community practicing solo practitioners. So we have good penetration in all of those. We're about 50% penetrated in COEs. As I mentioned, they treat about 25% of Rett patients, they represent about 1/3 of the prescriptions we have to date. That middle category, which is the largest at 60% of high-volume institutions, a good penetration there, and it's an area of focus for us today to continue to penetrate that further, which is, obviously, the largest component of Rett patients. And then in the community practices where many times physicians maybe 1 patient or 2 Rett patients, we have very good penetration there. So when we look at the totality of prescribing physicians, we have over 750 physicians that have prescribed DAYBUE at this point, that's a very, very high number this early in the launch. And our area of focus today tends to be -- is focused on continuing to draw patients from COEs. We have a lot more penetration to be gained there, really maximize the penetration in high-volume institutions and continue to pull from the community.

Great. Now you lowered guidance during last quarter's earnings. Can you just talk more about what factors go into achieving either the high end or the lower end?

Yes. I'm going to start and let Mark add a little bit of additional color here. But the -- where we're tracking at the moment would put us just below the midpoint of the guidance. And so what that tells us is there's -- we feel like there's more upside in the guidance than the downside. So things would need to deteriorate from where we're trending and tracking at the moment to be at the low end. And at the up end -- the higher end, we felt like it was appropriate to have a higher -- or more on the upside on the high end to reflect the fact that we're only 16 months into the launch. There's still the error bars, as we like to say, are still relatively wider than they will be a year from now or 2 years from now. And so there's still quite a bit of potential upside in terms of just how far we advance this year. When we look at maybe more broadly at all of the key factors that would inform our view of what the long-term success of the drug will be, what are the long-term revenues, we know all the key inputs for that. We've shared all of the key inputs with Wall Street. And all of those key performance indicators remain intact today. So we continue to see a very, very bright long-term future for DAYBUE and continue to be very optimistic about the benefits that we're seeing in our real-world evidence studies, the overall profile that we're seeing with the drug and continue to support, as I've said many times that we believe this will be a very substantial drug. Mark, anything...

When you just think about this year's for revenue, it really comes down to how many patients are on therapy and how much of the product are they utilizing. And so I think the biggest factor is kind of the patients on therapy, both gross adds, net of discontinuations. And that's kind of the biggest assumption that kind of factors the widest element of the range and then some element on what's the utilization of the patient base, and that gets us to the range that we put out on the second quarter comp.

And Steve, you talked about the proportion of patients coming from centers of excellence or high-volume centers. But I guess as launch matures, can you just talk about your expectations because you also mentioned that you see that shifting. But can you just talk about your expectations for the proportion of new patient starts that you see coming from those different segments?

Yes. So as I mentioned, we continue to get a high volume of patients from centers of excellence. So there's still a lot of additional penetration to be gained there. On the high-volume institutions, those are institutions that typically did not participate in our Phase III program. They don't have as much familiarity with the drug. They're gaining that. And so a big area of focus for us currently is to educate them further about the drug. We do that through sharing results of our real-world evidence, as I described, both on the benefit side as well as job management strategies. We do that through encouraging and help [indiscernible] to facilitate peer-to-peer discussions through case study publications from physicians that operate typically as COEs. And so there's a very large education campaign going on right now to try to bring that group of physicians up to kind of a parity or a similar level of knowledge and understanding of the drug. Neurologists tend to be -- people oftentimes say that they tend to be relatively conservative as treating physicians. And so some physicians even in -- when it's a rare disease and it's the only drug approved, to get a little bit of experience before they put a higher number of patients on therapy or they like to have more peer-to-peer discussions and just see how the drug is doing. Some physicians just has a policy, say I don't [ like ] the drug for the first year. So all those things factor into where we stand today. But as I've mentioned, we feel very good about the penetration at this point. We're well ahead of where we projected it would be prior to the launch.

And then given that DAYBUE is the only approved therapy for Rett syndrome, and there's relatively high rates of awareness amongst physicians and patients, why do you think that only 30% have initiated DAYBUE treatments after 1.5 years and what kind of gating factors do you see for patients?

Yes. I understand the question. It's a natural one when you have a rare disease and no drug ever approved. It's tempting to think, well, everyone will get on therapy as soon as the drug is approved. A lot of the factors that I just described in terms of physicians and how they tend to manage new drugs come into play here. I think importantly, and maybe this is just a helpful context. We've looked at a number of analogs of rare disease drugs to see where they stand in terms of their overall penetration at about this point in time. And again, we're just over 16 months on the market, and we are ahead of the norm or the average of those comparators. So it just underscores that even when you have a rare disease, even when you have a very, very high unmet need, very significant medical issues, it just takes time. It takes time to get physicians with sufficient experience to understand the drug, have confidence in prescribing the drug. It takes time for families many times to get in to see their physicians. We still have some families that are 6 months or more out from being able to see their doctor that -- who have expressed interest in getting on DAYBUE. So there are a number of things that take time. And what we're experiencing is not uncommon at all. In fact, as I mentioned, we're running a little bit ahead of the analogs that we see.

And do you have updated thoughts on the long-term persistency rate and have discontinuations have been -- have they been fairly stable? Or is there any reason to believe that this could still change meaningfully over time?

Yes. So there are three observations here. One is we -- well, first of all, let me just lay a little bit of a foundation. Any time you have a drug that's approved on subjective endpoints. So you're not measuring blood pressure, looking at a biomarker in a plasma sample, et cetera, you'll have some patients that don't respond or they don't perceive response or they don't perceive a response in the time frame that's relevant to them. That happens all the time in neuropsychiatry where we have subjective endpoints. And we see that in areas like Rett also where DAYBUE is approved based on subjective assessments. So you'll always have some of that. I would say in terms of the overall response that we're seeing, particularly as we look at our real-world evidence study, we're very pleased with that. So while that's a component of patients discontinuing, we're very pleased overall with the response that we're seeing. The patients who start on DAYBUE and started on DAYBUE in our clinical trial studies and particularly those that or specifically those that rolled over to DAYBUE that started on placebo in our Phase III program, but then in open-label extension rolled over to DAYBUE, are the most similar to what -- to the real-world experience that we're living in the commercial world. And so we have that data set. What was the persistency rate of those patients in that most like the real world experience, what was their persistency rate in a month, 3 months, 6 months, 9 months. And so we have that data set. And from the time we've launched, we've very consistently run about 10 percentage points above that persistency experience from our clinical trials. That clinical trial, that comparison ran for 9 months. We obviously have patients that have been on now more than 9 months. So we're continuing to see data from that curve. And from our clinical trial experience, we don't have DAYBUE at 9 months, but we kind of skip all the way forward to 2 or 3 years on therapy. So all the patients that started on DAYBUE in our clinical trials, of all of those patients have started, 40% are still on therapy today. That means, at this point in time, they've been on -- well over 3 years when the drug was launched, they were on therapy over 2 years. Almost all of the patients that rolled over from our clinical trial experience to commercial product remain on therapy today. And I mentioned it's about 40% of those who started on therapy. That tells us there's a sizable enduring population. I mentioned also that we're running about 10 percentage points as far as we have a comparison that's out through 9 months. And if we continue that 10 percentage points advantage, then that would suggest that longer term, we should expect half of patients that start therapy to stay on DAYBUE's long-term enduring patients. I think we can do even better than that. Today, we're 16 months into the launch. We still see a quite a bit of variability in how physicians initiate therapy, some titrate, some start at full dose and dose adjust as appropriate. Some remain in very close contact with their patients and set up a follow-up visit immediately when they start on therapy, some might longer. This will all resolve into kind of a set of best practices over time. And we're doing everything we can to facilitate that and try to have that evolve as quickly as we can. So this 10 percentage point advantage over what we observed in clinical studies that I referred to earlier, we feel like that's despite the fact that we don't yet have a really consistent set of best practices that are being adhered to. That's obviously something we're very, very focused on. And I think over time, there's an opportunity for us to improve on the persistency even more than the 10 percentage points above our clinical trial experience that we're seeing today.

Now it seems that many of the discontinuations are currently occurring early on in treatment. Is there an opportunity to retreat those patients? And do you have any numbers or anecdotal stories of patients who are retreated?

We do. So there are a few takeaways from that. We -- it's just -- it's important to underscore that Rett patients have very complicated medical histories. They are in and out of the hospital from time to time. They frequently have seizures, they have respiratory issues. So they have a lot of Rett. They have a lot of GI issues. And so as a consequence, sometimes patients will come off and on therapy. And so as we learn more about the drug, learn more about practice in the community, I think we'll be able to feed that information back. But at this point in time, very pleased with what we're seeing.

Okay. Can you just talk about your expanded license agreement with Neuren Pharmaceuticals? And just remind us of the time lines for potentially ex U.S. launches?

I'll take the first part. I'll ask Liz to handle the second part. So when we start our first deal with Neuren to acquire rights to DAYBUE, our rights for North American only. Neuren retained rights outside of North America. Soon after launching, we -- so a little over a year ago, we struck a deal with Neuren to acquire global rights so all of the ex North American rights. That deal had 2 components. One was to acquire those ex North American rights. The other was to get rights to another molecule that Neuren is developing for other indications, and we acquired rights to that molecule in Rett and in Fragile X. So that's the nature of the deal. Liz, I will turn it over you to speak to potential approvals in other geographies.

We're making good progress on our aims to bring DAYBUE to patients living outside of the U.S. First off, we have already applied in Canada. That's under priority review at this point. And so we'd look for an answer on that towards the latter part of the year. The next big milestone there is in the first quarter of next year, which is when we plan to make our European applications and could look to a decision there, roughly a year thereafter. We have had some initial and encouraging discussions with PMDA to explore the possibility in Japan as is typically the case, they are looking for some Japanese patient-specific data. So there's going to be some clinical work that's necessary there. But we're in good discussions about what that program could look like. So a number of different frontiers from a geography perspective.

And maybe to follow up on the geographies. How should we be thinking about the market and patient opportunities in Canada, Europe and Japan?

So the [ prevalent ] population in Europe is a little bit larger than in the United States. As we've said, the United States population is estimated to be between 6,000 and 9,000 patients. In Europe, it's estimates are more than 9,000 to 14,000. Vicinity in Japan, they're a little bit smaller than in the United States. So they're sizable populations. There are typically geographical differences in pricing and other considerations as well. But we view the ex U.S. and the ex North American opportunity to be very attractive.

Great. Let's shift to ACP-204. Can you just remind us how it's differentiated from NUPLAZID and when we might see updates from this program?

Sure. Liz, do you want to take that?

All right. So as a bit of a reminder, a backgrounder, ACP-204 is our next generation. So NUPLAZID is a 5HT2A inhibitor, and we look at the same mechanism with 204. NUPLAZID is a good strong foundation. But as we were looking at ways that we might want to improve on that, there were a few key pieces in our target product profile. The first of these is about QT prolongation. We do have a signal. It's at a low level with NUPLAZID, but it is there. It was obvious from a preclinical perspective and then showed itself clinically. With 204, we are not seeing that. That's important for a couple of reasons. The first of those is just the possibility of avoiding QT prolongation in older populations that can be pretty vulnerable. But also, what that did for NUPLAZID was it limited our ability to really dose range. There is some possibility that higher exposures might be associated with additional efficacy. We're going to be able to explore that with 204. So in our current study, we're looking at a dose range that the lower dose in the study is roughly equivalent to the exposure that NUPLAZID provides and higher dose is roughly twice. So that will let us actually explore the hypothesis about whether additional exposure will give you additional efficacy. And then finally, we are able to get to steady state a little bit faster with 204, roughly twice as fast. There is some potential that, that could lead to an increase in how quickly you're able to get to efficacy. We'll be able to explore all of those in the clinical program. So those are the pieces of differentiation that we're looking for. We've been able to check all of them nicely off in terms of what we've seen both frequently and from a Phase 1 perspective at this point and currently have taken 204 into a Phase II, Phase III master protocol program in Alzheimer's disease psychosis.

And for that master protocol, when might we hear an update from the EU on whether they reached agreement on the master protocol?

Yes. So my anticipation at this point, again, for people who may not have heard the earnings call, we talked about the fact that Europe was interested in participating in the Phase II, but was not yet ready to prepare -- to participate in the Phase III portion that was under our master protocol. We anticipate that we'd be going back to them once we have data from the Phase II trial in hand. We haven't given specifics around that, but think about that in the course of the next couple of years.

And how are you trying to mitigate placebo response in the 204 studies?

There are a lot of things that we have learned from NUPLAZID development as well as things that have come about as a result of really an evolving paradigm in the Alzheimer's field generally speaking. So it's one of the key things we've really been focusing in on is the patient population, and that has a couple of different aspects to it. One is from our prior work. We did see some indication that more severe patients were more likely to have a response. And so we are looking at a more severe patient subset. A component that really is reflective of the way Alzheimer's. Alzheimer's treatment generally is evolving is that we are also looking for biomarker confirmed Alzheimer's disease. Historically, this has really been a clinical diagnosis, but this is very much an evolving space. And we think that having that biomarker confirmed patient population is going to give us really the most robust data set. There are other things that we're doing in terms of pretty rigorous training and testing of sites around the instruments that we're using and some tools that we're giving to caregivers and importantly, that we're giving to caregivers during the screening period to make sure they are best supporting their loved ones. That's great from an individual patient care perspective. But doing that during the screening period, also means, hopefully, you've hit stability by the time you get to baseline. And so you're less likely to see that come out as a placebo response.

Okay. Great. Maybe shifting to ACP-101. Can you just walk us through your Prader-Willi program and where you see ACP-101 fitting into the treatment landscape?

Liz?

Sure. So ACP-101 right now, we have in a Phase III trial. It is a randomized double-blind, placebo-controlled multisite trial. This is a follow-on from a previous Phase III trial where this agent was investigated both at a higher dose and a lower dose. The higher dose had some numerical improvements, but it wasn't statistically significant. The lower dose had some pretty consistent data that had nominal statistical significance and a larger delta from placebo. We've taken the learnings from that trial into this new trial. We're looking at the same endpoint that we looked at previously. We're looking at the 3.2 milligram dose. That's the lower dose. And we think that we have a program such that if we replicate the kind of effects that we saw in the previous trial was a 3.2 milligram dose, we should have a robust data package to take to regulators. As I think about the treatment landscape, there are a number of different agents out there. Obviously, the most advanced is from Soleno. They very recently announced that their drug was considered filed, that they were going to have an advisory committee and that they were going to get priority review. We're obviously watching that very closely. But I'll say a couple of things. One, I think that we are heartened to see that FDA is thinking of this as I think they should, is the kind of disease where you do think about things like priority review, et cetera. This is a disease with serious unmet needs that has no real treatment options. And along those lines, the unmet need in this patient population is so significant that assuming Soleno gets to market, assuming we get to market, I think this is the kind of space where it is very likely that there are going to be multiple medications that are going to be relevant depending on the specifics of the patient population can be used either sequentially or frankly, possibly even in combination in future.

And I think just to maybe annotate Liz's final point. We've seen this before in rare disease. A couple of examples are SMA, HAE, where multiple drugs are approved and where the unmet needs are sufficiently high that it accommodates multiple successful drugs.

And so how is enrollment in the Phase III study been going?

So this is a new space for us. And when you go into a new space, one of the things that's always pretty important to get a gauge on is investigator enthusiasm. And I have to say, we've been really pleased with the degree of enthusiasm we're seeing from the sites and investigators participating in the program. Overall, I consider the enrollment to be going well. We're not providing further specifics on it just yet, but will as the program continues.

And this patient population may be more prone to obesity or conditions, such as Type 2 diabetes. So how are you accounting for background therapies in the study? And do you expect this to have any impact on the study results?

Do you want me to jump in?

Yes, please go ahead. You're on a roll.

I'll keep on going. So absolutely right that these patients have a number of difficult comorbidities that they're dealing with. We are typically allowing a pretty wide variety of background medications that deal with aspects of the disease that we really don't anticipate that 101 is likely to touch. We are generally requiring that those stay stable for different periods of time depending on what they are. There are, of course, some agents that we're not allowing in the study, those places where we thought that there was a likelihood to actually impact on the clinical trial results. But generally, we're looking for stability in medications and trying to make sure these patients are supported in all the ways they need to be.

And then for the primary endpoint of hyperphagia questionnaire for clinical trials, what would be considered clinically meaningful?

There are a lot of different ways to answer that question. In terms of the literature, there are values for a minimum clinically important difference that are as low as about $2.5 million. I'd say, again, if we see data in our Phase III trial that are similar in their magnitude to what was seen in the prior Phase III for the 3.2 milligram dose, I think we feel very confident that we had something that was clinically meaningful. I will note, there are also in the literature data supporting responder levels that are quite a bit higher than that. So roughly 8 points of change. It's not our primary endpoint, but we are looking at responder analyses in addition to the change from baseline that's our primary.

Great. Well, maybe in the last few minutes, just one last question on NUPLAZID. You've noted seeing growth in this stabilized PDP market. So how are you thinking about future growth opportunities, with potential impact from your DTC campaign and how it complements your upcoming disease awareness campaign?

So I need to provide just a little bit of context here. So when we launched NUPLAZID in Parkinson's disease psychosis, we saw this very linear growth curve that produced attractive revenue growth quarter-over-quarter, year-over-year. One important element of that growth was disease awareness. It's important in this indication in particular, because many times when physicians diagnose a patient with Parkinson's, they many times don't say there's a 50-50 shot that in 10, 12, 15 years, you may start seeing things that aren't there or believing things that are not real, having hallucinations or delusions. And so when it happens, and it does happen in almost 50% of Parkinson's patients, it happens later in the disease state. And families just don't connect the dots. They just don't -- it doesn't -- I don't know of a reason to think that it would be related to Parkinson's because they think of it more as a movement disorder. And so -- and because it happens late, the lifespan of average Parkinson's patients once they have psychosis is 4 or 5 years. And so it's a pretty dynamic population that turns over. And so providing additional disease education to this community is very important because if we're not doing that and helping encourage a dialogue between patients, families and their doctors, then many times, it just doesn't happen. Patients go untreated or they go and treat it for a very long time, many times they want to be in ER and kind of a desperate situation. The pandemic hit this population very hard. So we pulled back on the disease awareness work that we were doing because we felt like it was just not an environment where it was having the advantages that we had previously seen. Our sales went much more flattish for a few years. And -- but we said at the time that if we -- if the environment changes, we reserve the right to come back and we may make some additional investments here on a very prudent basis. The PDP market is now stabilized. So the environment has changed. And in the meantime, we've seen awareness of hallucinations and delusions in Parkinson's patients and their families plummet. It's gone down dramatically since we've not been out there providing that level of disease education. The awareness of NUPLAZID has gone down significantly. The awareness -- or the number of times that patients make a request with their physician for NUPLAZID, it's gone down significantly. The one thing that hasn't changed is physicians' willingness to honor a branded request when it's made. So we feel like now that the part of the market has stabilized, there's an opportunity to really fill that gap now. And so we've recently announced -- we've initiated a very extensive disease awareness campaign to fill that gap, and we think the environment is now ripe to leverage that for the benefit of the community and also we think it will have an impact on our business as well. We're doing that on the heels of some really nice organic growth that we're seeing in our PDP franchise. And that's -- there are really 2 undercurrents there that are providing that organic growth. One is there have been 3 real-world evidence studies published in the last 1.5 years, two of which show a statistically significant advantage on mortality for patients treated with NUPLAZID versus other atypical antipsychotics; and the third showed a statistically significant benefit on -- for NUPLAZID on health care utilization cost versus other atypical antipsychotics. That's one undercurrent. We've been getting that information out into the medical community. It's been resonating and we're seeing growth as a consequence of that. And the second is there was a part of the label that was kind of worded awkwardly and some physicians found it confusing and mistakenly believe that a Parkinson's patient with psychosis that -- and also had dementia they couldn't prescribe the drug for them. We worked with the FDA. We got that clarified, label changed. And now, we can say very confidently with a high degree of conviction, doctor, if you have a patient that has Parkinson's psychosis and they have dementia, is on label, you can treat them with NUPLAZID. And so we're seeing growth as a consequence of that, too. So we have these 2 undercurrents that have caused some really nice organic growth with NUPLAZID. And then on top of that, we've just launched this disease awareness campaign. There are 2 components to that. One is branded campaign similar to the types of campaigns we've heard in the past. The other is a disease awareness, unbranded campaign, where we partnered with Ryan Reynolds. Some of you may have seen some of the work that we've done with him. He's a very outspoken advocate of mental health. He's also a very strong supporter of the Parkinson's community. He's on the Board of Directors of the Michael J. Fox Foundation. He's good friends with Michael J. Fox. And he's never done any work with pharmaceutical companies. This resonated with him. We're working with him not because he's Ryan Reynolds, but because his family story is so compelling. He's father had Parkinson's. He had Parkinson's psychosis. He died a year before NUPLAZID was approved. And he and his family struggle with all the things we hear on a regular basis for Parkinson's families. They don't associate the psychosis with the disease. It is very disruptive. It's very debilitating to the patient. And all of the things that we hear and have been hearing on a regular basis prior years, he lived. He's just a fantastic spokesman. He -- for those of you who are familiar with his work, he is highly compelling. He speaks with a high degree of conviction and he's super excited about helping this community.

Great. Well, looks like we'll have to leave it there. Thanks so much for your time.

Thanks a lot.

Thank you.